Controls and Procedures
−Removed: As of the end of the period covered by this Annual
−Removed: Report on Form 10-K, we carried out an evaluation, under the supervision and with the participation of our management, including our
−Removed: Chief Executive Officer and our Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls
−Removed: and procedures (as defined in the Exchange Act Rules 13a-15(e) and 15d-15(e)) (the “Exchange Act”).
−Removed: Based on the foregoing
−Removed: evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures are effective
−Removed: to ensure that information required to be disclosed by us in the reports we file or submit under the Exchange Act is recorded, processed,
−Removed: summarized and reported within the time periods specified in the rules and forms of the SEC, and that such information is accumulated
−Removed: and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding
−Removed: required disclosures.
−Removed: Changes in Internal Control Over Financial Reporting
−Removed: Other than the appointment of our current Chief
−Removed: Financial Officer as interim Chief Executive Officer in addition to his role as our Chief Financial Officer on October 4, 2021, there
−Removed: were no changes in our internal control over financial reporting during our fourth quarter ended December 31, 2021, or in other factors
−Removed: that could significantly affect these controls, that materially affected, or are reasonably likely to materially affect, our internal
−Removed: control over financial reporting.
−Removed: Management’s Annual Report on Internal Controls Over Financial
−Removed: Our management is responsible
−Removed: for establishing and maintaining adequate internal control over financial reporting and for the assessment of the effectiveness of internal
−Removed: control over financial reporting.
−Removed: As defined by the Securities and Exchange Commission, internal control over financial reporting is
−Removed: a process designed by, or under the supervision of, our principal executive and principal financial officers and effected by our Board
−Removed: of Directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the
−Removed: preparation of the consolidated financial statements in accordance with U.S.
−Removed: generally accepted accounting principles.
−Removed: Our internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that,
−Removed: in reasonable detail, accurately and fairly reflect our transactions and dispositions of our assets;
+Added: of the end of the period covered by this Annual Report on Form 10-K, we carried out an evaluation, under the supervision and with the
+Added: participation of our management, including our Chief Executive Officer and our Chief Financial Officer, of the effectiveness of the design
+Added: and operation of our disclosure controls and procedures (as defined in the Exchange Act Rules 13a-15(e) and 15d-15(e)).
+Added: Based on the foregoing evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure
+Added: controls and procedures are effective to ensure that information required to be disclosed by us in the reports we file or submit under
+Added: the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC,
+Added: and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial
+Added: Officer, to allow timely decisions regarding required disclosures.
+Added: in Internal Control Over Financial Reporting
+Added: than the appointment of our Chief Executive Officer, effective May 10, 2022, there were no changes in our internal control over financial reporting
+Added: during our year ended December 31, 2022, or in other factors that could significantly affect these controls, that materially affected,
+Added: or are reasonably likely to materially affect, our internal control over financial reporting.
+Added: Annual Report on Internal Controls Over Financial Reporting
+Added: management is responsible for establishing and maintaining adequate internal control over financial reporting and for the assessment
+Added: of the effectiveness of internal control over financial reporting.
+Added: As defined by the Securities and Exchange Commission, internal control
+Added: over financial reporting is a process designed by, or under the supervision of, our principal executive and principal financial officers
+Added: and effected by our Board of Directors, management and other personnel, to provide reasonable assurance regarding the reliability of
+Added: financial reporting and the preparation of the consolidated financial statements in accordance with U.S.
+Added: generally accepted accounting
+Added: Our internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records
+Added: that, in reasonable detail, accurately and fairly reflect our transactions and dispositions of our assets;
(2) provide reasonable assurance
4 unchanged sentences
of our assets that could have a material effect on the consolidated financial statements.
−Removed: Because of its inherent limitations, internal
−Removed: control over financial reporting may not prevent or detect misstatements.
−Removed: Also, projections of any evaluation of effectiveness to future
−Removed: periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance
−Removed: with the policies or procedures may deteriorate.
−Removed: In connection with the preparation of our annual
−Removed: consolidated financial statements, management, including, our Principal Executive and Financial Officer, has undertaken an assessment
−Removed: of the effectiveness of our internal control over financial reporting as of December 31, 2021, based on the criterial established
−Removed: in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
−Removed: Management’s assessment included an evaluation of the design of our internal control over financial reporting and testing of the
−Removed: operational effectiveness of those controls.
−Removed: Based on this evaluation, management has concluded
−Removed: that our internal control over financial reporting was effective as of December 31, 2021.
+Added: of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.
+Added: Also, projections of
+Added: any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions,
+Added: or that the degree of compliance with the policies or procedures may deteriorate.
+Added: connection with the preparation of our annual consolidated financial statements, management, including, our Principal Executive and Financial
+Added: Officer, has undertaken an assessment of the effectiveness of our internal control over financial reporting as of December 31, 2022,
+Added: based on the criterial established in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations
+Added: of the Treadway Commission (“COSO”).
+Added: Management’s assessment included an evaluation of the design of our internal control
+Added: over financial reporting and testing of the operational effectiveness of those controls.
+Added: on this evaluation, management has concluded that our internal control over financial reporting was effective as of December 31,
Other Information
−Removed: Not applicable.
−Removed: Disclosure Regarding Foreign Jurisdictions that Prevent
−Removed: Not applicable.
+Added: Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Directors, Executive Officers, and Corporate Governance
−Removed: We have adopted a written Code of Conduct and
−Removed: Ethics that applies to our directors, executive officers and all employees.
−Removed: We intend to disclose any amendments to, or waivers from,
−Removed: our code of ethics and business conduct that are required to be publicly disclosed pursuant to rules of the SEC by filing such amendment
−Removed: or waiver with the SEC.
−Removed: This code of ethics and business conduct can be found in the “Investors - Corporate Governance” section
−Removed: of our website, www.cormedix.com .
−Removed: Delinquent Section 16(a) Reports
−Removed: Section 16(a) of the Exchange Act requires our
−Removed: directors, executive officers and holders of more than 10% of our common stock to file with the SEC initial reports of ownership and reports
−Removed: of changes in the ownership of our common stock and other equity securities.
−Removed: Such persons are required to furnish us copies of all Section
−Removed: 16(a) filings.
−Removed: To our knowledge, based solely on a review of the copies of such reports furnished to us and representations that no other
−Removed: reports were required, during the fiscal year ended December 31, 2021, all Section 16(a) filing requirements applicable to its officers,
−Removed: directors and greater than ten percent beneficial owners were complied with, except as to the following:
−Removed: (i) Dr, David was not timely
−Removed: in filing a Form 4 for changes in beneficial ownership that occurred on November 1, 2021, the changes in beneficial ownership were reported
−Removed: on November 10, 2021;
−Removed: Kaplan was not timely in filing a Form 4 for changes in beneficial ownership that occurred on November
−Removed: 16, 2021, the changes in beneficial ownership were reported on November 19, 2021.
−Removed: The following table sets forth the name, age and position of each of
−Removed: our directors as of March 25, 2022:
+Added: have adopted a written Code of Conduct and Ethics that applies to our directors, executive officers and all employees.
+Added: We intend to disclose
+Added: any amendments to, or waivers from, our code of ethics and business conduct that are required to be publicly disclosed pursuant to rules
+Added: of the SEC by filing such amendment or waiver with the SEC.
+Added: This code of ethics and business conduct can be found in the “Investors
+Added: – Corporate Governance” section of our website, www.cormedix.com .
+Added: following table sets forth the name, age and position of each of our directors as of March 15, 2023:
Director Since
Position(s) with CorMedix
+Added: Joseph Todisco
+Added: Director and Chief Executive Officer
September 2020
4 unchanged sentences
Steven Lefkowitz
−Removed: Joseph Todisco
−Removed: Costa has been a director
−Removed: of CorMedix since September 2020.
−Removed: Costa previously served as President and Chief Executive Officer of Novartis U.S.
−Removed: from October 2005 to August 2008.
+Added: Todisco became a director of CorMedix in March 2022.
+Added: Prior to joining CorMedix as our Chief Executive Officer, he was a senior
+Added: executive at Amneal Pharmaceuticals, where for the past 11 years he has held various roles, most recently as Executive Vice President,
+Added: Chief Commercial Officer where he was responsible for Amneal Specialty, a growing branded products business.
+Added: During his tenure at Amneal,
+Added: Todisco held roles overseeing corporate development and international operations, leading commercial teams in several international
+Added: markets including the UK, Australia and Germany, as well as leading Amneal’s merger integration with Impax Laboratories in 2018.
+Added: He was previously Co-Founder and managing executive of Gemini Laboratories, a specialty pharmaceutical company focused on the sales and
+Added: marketing for niche branded products in the US Market.
+Added: Gemini Laboratories was established as an affiliate of Amneal Pharmaceuticals
+Added: and was subsequently acquired by Amneal in 2018.
+Added: Prior to joining Amneal, Mr.
+Added: Todisco was Vice President, Business Development &
+Added: Licensing at Ranbaxy, Inc.
+Added: where he was responsible for developing and executing Ranbaxy’s North American commercial business strategy.
+Added: Prior to Ranbaxy, he held various roles at Par Pharmaceutical, and in his earlier career held positions at Oppenheimer & Company
+Added: and Marsh & McLennan Companies.
+Added: Todisco obtained his MBA in finance from Fordham Graduate School of Business and his BA in Economics
+Added: from Georgetown University.
+Added: Among other qualifications, attributes and skills, Mr.
+Added: Todisco’s business expertise and significant
+Added: executive management experience in the pharmaceutical industry led to the conclusion of our Board that he should serve as a director
+Added: of our Company in light of our business and structure.
+Added: Costa has been a director of CorMedix since September 2020.
+Added: Costa previously served as President and Chief Executive Officer
+Added: of Novartis U.S.
+Added: Corporation, from October 2005 to August 2008.
Prior to his work at Novartis U.S.
Corporation, Mr.
−Removed: Costa was President and Chief
−Removed: Executive Officer of Novartis Pharmaceuticals, U.S.
+Added: Costa was President
+Added: and Chief Executive Officer of Novartis Pharmaceuticals, U.S.
from July 1999 to September 2005.
1 unchanged sentence
spent 30 years at Johnson & Johnson, including as President of Janssen Pharmaceutica, Inc.
−Removed: From August 2009 to August 2012,
−Removed: Costa served as Chairman of the Board of Amylin Pharmaceuticals Inc, a commercial stage biopharma company, until its sale to
−Removed: Bristol-Myers Squibb and AstraZeneca in a $7 billion transaction in 2012.
−Removed: Costa currently serves as Chairman of the Board
−Removed: of MacroGenics, Inc., a public late stage biopharma company focused on oncology.
−Removed: Costa received his undergraduate degree from
−Removed: São Paulo School of Business Administration and earned a master’s degree in business administration from Harvard Business
+Added: from 1992 to 1998.
+Added: From August 2009 to
+Added: August 2012, Mr.
+Added: Costa served as Chairman of the Board of Amylin Pharmaceuticals Inc, a commercial stage biopharma company, until its
+Added: sale to Bristol-Myers Squibb and AstraZeneca in a $7 billion transaction in 2012.
+Added: Costa served as Director from June 2009 to October
+Added: 2013 and Chairman until May 2022 of MacroGenics, Inc., a public oncology focused biopharma company.
+Added: Costa received his undergraduate
+Added: degree from São Paulo School of Business Administration and earned a master’s degree in business administration from Harvard
+Added: Business School.
Among other experience, qualifications, attributes and skills, Mr.
−Removed: Costa’s significant depth of experience in the
−Removed: pharmaceutical industry, including service as a director and executive of pharmaceutical companies, led to the conclusion of our Board
−Removed: that he should serve as a director of our Company in light of our business and structure.
−Removed: Janet Dillione has been a director
−Removed: of CorMedix since August 2015.
+Added: Costa’s significant depth of experience in
+Added: the pharmaceutical industry, including service as a director and executive of pharmaceutical companies, led to the conclusion of our
+Added: Board that he should serve as a director of our Company in light of our business and structure.
+Added: Dillione has been a director of CorMedix since August 2015.
Since November 2020, Ms.
−Removed: Dillione currently serves as the Chief Executive Officer of Connect
−Removed: America, a nationally recognized leader in comprehensive telehealth and remote patient monitoring solutions.
−Removed: Prior to joining Connect
−Removed: America, she served as Chief Executive Officer of Bernoulli Enterprise, Inc.
−Removed: since May 2014, a real-time connected healthcare information
−Removed: technology company.
−Removed: Previously, she was at Nuance Communications, Inc., a leading provider of voice and language solutions for businesses
−Removed: and consumers around the world, having joined Nuance in April 2010 as Executive Vice President and General Manager of the Healthcare
−Removed: Division and serving as an executive officer from March 2010 until May 2014.
−Removed: From June 2000 to March 2010, Ms.
−Removed: held several senior level management positions at Siemens Medical Solutions, a global leader in medical imaging, laboratory diagnostics,
−Removed: and healthcare information technology, including President and CEO of the global healthcare IT division.
−Removed: Dillione currently serves
−Removed: as a director of Vizient, Inc., a private health care performance improvement company.
−Removed: Dillione received her B.A.
−Removed: from Brown University
−Removed: in 1981 and completed the Executive Program at The Wharton School of Business of the University of Pennsylvania in 1998.
−Removed: 25 years of experience leading global teams in the development and delivery of healthcare technology and services.
−Removed: Among other qualifications,
−Removed: attributes and skills, Ms.
−Removed: Dillione’s financial expertise and significant executive management experience with medical device and
−Removed: healthcare companies led to the conclusion of our Board that she should serve as a director of our Company in light of our business and
−Removed: Gregory Duncan has been a director
−Removed: of CorMedix since November 2020.
−Removed: Duncan currently serves as the Chairman and CEO of Virios Therapeutics, a clinical-stage
−Removed: biopharmaceutical company developing and commercializing innovative antiviral therapies to treat diseases associated with a viral triggered
−Removed: abnormal immune response, such as fibromyalgia (FM), and has served since April 2020.
−Removed: From 2014 and prior to joining his current
−Removed: company earlier this year, Mr.
−Removed: Duncan served as President and CEO of Celtaxsys, a privately held biotechnology company focused on
−Removed: cystic fibrosis and other rare, inflammatory diseases.
−Removed: Duncan has spent the majority of his career in senior leadership roles
−Removed: in commercial stage pharmaceutical companies.
−Removed: From 2007 to 2013, he served as a senior executive at UCB, including as President of its
−Removed: North America business, as well as an executive committee member.
+Added: Dillione has served as the Chief Executive
+Added: Officer of Connect America, a nationally recognized leader in comprehensive telehealth and remote patient monitoring solutions.
+Added: to joining Connect America and starting in May 2014, she served as Chief Executive Officer of Bernoulli Enterprise, Inc., a real-time
+Added: connected healthcare information technology company.
+Added: Previously, she was at Nuance Communications, Inc., a leading provider of voice
+Added: and language solutions for businesses and consumers around the world, having joined Nuance in April 2010 as Executive Vice President
+Added: and General Manager of the Healthcare Division and serving as an executive officer from March 2010 until May 2014.
+Added: From June 2000 to
+Added: March 2010, Ms.
+Added: Dillione held several senior level management positions at Siemens Medical Solutions, a global leader in medical imaging,
+Added: laboratory diagnostics, and healthcare information technology, including President and CEO of the global healthcare IT division.
+Added: Dillione currently serves as a director of Vizient, Inc., a private health care performance improvement company.
+Added: Dillione received
+Added: from Brown University in 1981 and completed the Executive Program at The Wharton School of Business of the University of Pennsylvania
+Added: She has over 25 years of experience leading global teams in the development and delivery of healthcare technology and services.
+Added: Among other qualifications, attributes and skills, Ms.
+Added: Dillione’s financial and IT expertise and significant executive management
+Added: experience with medical device and healthcare companies led to the conclusion of our Board that she should serve as a director of our
+Added: Company in light of our business and structure.
+Added: Duncan has been a director of CorMedix since November 2020.
+Added: Duncan currently serves as the Chairman and CEO of Virios Therapeutics,
+Added: a clinical-stage biopharmaceutical company developing and commercializing innovative antiviral therapies to treat diseases associated
+Added: with a viral triggered abnormal immune response, such as fibromyalgia (FM), and has served since April 2020.
+Added: From 2014 and prior to joining
+Added: his current company, Mr.
+Added: Duncan served as President and CEO of Celtaxsys, a privately held biotechnology company focused on cystic fibrosis
+Added: and other rare, inflammatory diseases.
+Added: Duncan has spent the majority of his career in senior leadership roles in commercial stage
+Added: pharmaceutical companies.
+Added: From 2007 to 2013, he served as a senior executive at UCB, including as President of its North America business,
+Added: as well as an executive committee member.
Prior to his roles with UCB, Mr.
−Removed: Duncan spent approximately 17 years
−Removed: at Pfizer where he gained significant experience across sales and marketing functions including serving as SVP of US Marketing and later
−Removed: as President of Pfizer’s Latin America business from 2005 to 2007.
−Removed: Duncan received his undergraduate degree from the State
−Removed: University of New York, Albany, and earned an MBA degree from Emory University.
−Removed: Among other experience, qualifications, attributes
−Removed: and skills, Mr.
−Removed: Duncan’s significant depth of experience in the pharmaceutical industry led to the conclusion of our Board
−Removed: that he should serve as a director of our Company in light of our business and structure.
−Removed: a director of CorMedix since March 2019.
−Removed: He is the founder and principal consultant of Danerius, LLC, a biotechnology and pharmaceutical
−Removed: consulting business which he started in 2006.
−Removed: From 1994, he served in senior positions in Research and Development in the Pharmaceutical
−Removed: Division of Johnson and Johnson including President and Managing Director of the Janssen, the major research, development and regulatory
−Removed: arm of the pharmaceuticals division at Johnson & Johnson.
−Removed: From January 2007 through March 2009, Dr.
−Removed: Dunton served
−Removed: as President and Chief Executive Officer of Panacos Pharmaceuticals, Inc.
+Added: Duncan spent approximately 17 years at Pfizer where he gained
+Added: significant experience across sales and marketing functions including serving as SVP of US Marketing and later as President of Pfizer’s
+Added: Latin America business from 2005 to 2007.
+Added: Duncan received his undergraduate degree from the State University of New York, Albany,
+Added: and earned an MBA degree from Emory University.
+Added: Among other experience, qualifications, attributes and skills, Mr.
+Added: Duncan’s significant
+Added: depth of experience in the pharmaceutical industry led to the conclusion of our Board that he should serve as a director of our Company
+Added: in light of our business and structure.
+Added: has been a director of CorMedix since March 2019.
+Added: He is the founder and principal consultant of Danerius,
+Added: LLC, a biotechnology and pharmaceutical consulting business which he started in 2006.
+Added: From 1994, he served in senior positions in Research
+Added: and Development in the Pharmaceutical Division of Johnson and Johnson including President and Managing Director of Janssen, the major
+Added: research, development and regulatory arm of the pharmaceuticals division at Johnson & Johnson.
+Added: From January 2007 through March 2009,
+Added: Dunton served as President and Chief Executive Officer of Panacos Pharmaceuticals, Inc.
From November 2015 through March 2018, Dr.
−Removed: was the Head/Senior Vice President of Research, Development and Regulatory Affairs of Purdue Pharma L.P., a private pharmaceutical company.
+Added: Dunton was the Head/Senior Vice President of Research, Development and Regulatory Affairs of Purdue Pharma L.P., a private pharmaceutical
Dunton received his Bachelor of Science degree in biochemistry, magna cum laude, from State University of New York at Buffalo,
2 unchanged sentences
In addition to CorMedix, Dr.
−Removed: Dunton currently serves on
−Removed: the boards of three public companies, as a Director at Palatin Technologies, Inc.
+Added: Dunton currently serves on the boards
+Added: of three public companies, as a Director at Palatin Technologies, Inc.
and Oragenics, Inc.
−Removed: he chairs the Compensation Committees
−Removed: of both companies.
+Added: he chairs the Compensation Committees of both
He also serves as a member of the Audit Committees of these companies.
Additionally, Dr.
−Removed: Dunton is a member of
−Removed: the board of Recce Pharma Ltd., an Australian public biotechnology company focused on developing novel anti-infectives for serious and
−Removed: life threatening diseases.
+Added: Dunton is a member of the board of
+Added: Recce Pharma Ltd., an Australian public biotechnology company focused on developing novel anti-infectives for serious and life threatening
Among other qualifications, Dr.
−Removed: Dunton’s significant depth of experience in the pharmaceutical
−Removed: industry, including service as a director of public pharmaceutical companies, led to the conclusion of our Board that he should serve
−Removed: as a director of our Company in light of our business and structure.
−Removed: Myron Kaplan became a director
−Removed: of CorMedix in April 2016.
−Removed: He is a founding partner of Kleinberg, Kaplan, Wolff & Cohen, P.C., a New York City general
−Removed: practice law firm, where he has practiced corporate and securities law for more than forty years.
−Removed: Kaplan became
−Removed: a trustee of the Lehman Brothers Plan Holding Trust.
−Removed: Previously, he served as a member of the board of directors of SAirGroup Finance
−Removed: (USA) Inc., a subsidiary of SAirGroup that had publicly issued debt securities, Trans World Airlines, Inc.
+Added: Dunton’s significant depth of experience in the pharmaceutical industry, including service
+Added: as a director of public pharmaceutical companies, led to the conclusion of our Board that he should serve as a director of our Company
+Added: in light of our business and structure.
+Added: Kaplan became a director of CorMedix in April 2016 and became Chairman of the Board in August 2017.
+Added: He is a founding partner
+Added: of Kleinberg, Kaplan, Wolff & Cohen, P.C., a New York City general practice law firm, where he has practiced corporate and securities
+Added: law for more than forty years.
+Added: Kaplan became a trustee of the Lehman Brothers Plan Holding Trust.
+Added: Previously, he served
+Added: as a member of the board of directors of SAirGroup Finance (USA) Inc., a subsidiary of SAirGroup that had publicly issued debt securities,
+Added: Trans World Airlines, Inc.
and Kitty Hawk, Inc.
−Removed: his business and civic involvements, Mr.
−Removed: Kaplan currently serves on the boards of directors of a number of private companies and
−Removed: has been active for many years on the boards of trustees and various board committees of The Children’s Museum of Manhattan
−Removed: and JBI International (formerly The Jewish Braille Institute of America).
−Removed: Kaplan graduated from Columbia College and holds a
−Removed: Juris Doctor from Harvard Law School.
−Removed: Among other experience, qualifications, attributes and skills, Mr.
−Removed: Kaplan’s experience
−Removed: in a broad range of corporate and securities matters and service as a director of public companies led to the conclusion of our Board
−Removed: that he should serve as a director of our Company in light of our business and structure.
−Removed: Steven Lefkowitz was a director of
−Removed: CorMedix from August 2011 to June 2016.
+Added: Among his business and civic involvements, Mr.
+Added: Kaplan currently serves on the boards
+Added: of directors of a number of private companies and has been active for many years on the boards of trustees and various board committees
+Added: of The Children’s Museum of Manhattan and JBI International (formerly The Jewish Braille Institute of America).
+Added: Kaplan graduated
+Added: from Columbia College and holds a Juris Doctor from Harvard Law School.
+Added: Among other experience, qualifications, attributes and skills,
+Added: Kaplan’s experience in a broad range of corporate and securities matters and service as a director of public companies led
+Added: to the conclusion of our Board that he should serve as a director of our Company in light of our business and structure.
+Added: Lefkowitz was a director of CorMedix from August 2011 to June 2016.
He was reappointed to the Board in June 2017.
−Removed: He also served as our acting Chief
−Removed: Financial Officer from August 2013 to July 2014.
−Removed: Lefkowitz has been the President and Founder of Wade Capital Corporation,
−Removed: a financial advisory services company, since June 1990.
+Added: He also served
+Added: as our acting Chief Financial Officer from August 2013 to July 2014.
+Added: Lefkowitz has been the President and Founder of Wade Capital
+Added: Corporation, a financial advisory services company, since June 1990.
Lefkowitz has been a director of both public and private companies.
4 unchanged sentences
qualifications, attributes and skills, Mr.
−Removed: Lefkowitz’s education, experience and financial expertise led to the conclusion
−Removed: of our Board that he should serve as a director of our Company in light of our business and structure.
−Removed: Joseph Todisco became a director
−Removed: of CorMedix in March 2022.
−Removed: Prior to joining CorMedix, he was a senior executive at Amneal Pharmaceuticals, where for the past 11 years
−Removed: he has held various roles, most recently as Executive Vice President, Chief Commercial Officer where he was responsible for Amneal Specialty,
−Removed: a growing branded products business.
−Removed: During his tenure at Amneal, Mr.
−Removed: Todisco held roles overseeing corporate development and international
−Removed: operations, leading commercial teams in several international markets including the UK, Australia and Germany, as well as leading Amneal’s
−Removed: merger integration with Impax Laboratories in 2018.
−Removed: He was previously Co-Founder and managing executive of Gemini Laboratories, a specialty
−Removed: pharmaceutical company focused on the sales and marketing for niche branded products in the US Market.
−Removed: Gemini Laboratories was established
−Removed: as an affiliate of Amneal Pharmaceuticals and was subsequently acquired by Amneal in 2018.
−Removed: Prior to joining Amneal, Mr.
−Removed: Todisco was Vice
−Removed: President, Business Development & Licensing at Ranbaxy, Inc.
−Removed: where he was responsible for developing and executing Ranbaxy’s
−Removed: North American commercial business strategy.
−Removed: Prior to Ranbaxy, he held various roles at Par Pharmaceutical, and in his earlier career
−Removed: held positions at Oppenheimer & Company and Marsh & McLennan Companies.
−Removed: Todisco obtained his MBA in finance from Fordham Graduate
−Removed: School of Business and his BA in Economics from Georgetown University.
−Removed: Among other qualifications, attributes and skills, Mr.
−Removed: business expertise and significant executive management experience in the pharmaceutical industry led to the conclusion of our Board that
−Removed: he should serve as a director of our Company in light of our business and structure.
−Removed: Board Independence
−Removed: Our Board has undertaken a review of the independence
−Removed: of our directors and has determined that (i) all current directors are independent within the meaning of Section 5605(b) of the Nasdaq
−Removed: Marketplace Rules, (ii) all members of our Audit Committee meet the additional test for independence for audit committee members imposed
−Removed: by SEC regulation and Section 5605(c) of the Nasdaq Marketplace Rules, (iii) all of the members of our Compensation Committee are independent
−Removed: within the meaning of Section 5605(d) of the Nasdaq Marketplace Rules, and (iv) all of the members of our Nominating and Governance Committee
−Removed: are independent within the meaning of Section 5605(e) of the Nasdaq Marketplace Rules.
−Removed: Board Committees
−Removed: Our Board has established an Audit Committee, a
−Removed: Compensation Committee and a Nominating and Governance Committee.
−Removed: Our Audit Committee currently consists of Mr.
−Removed: Lefkowitz (Chair),
+Added: Lefkowitz’s education, experience and financial expertise led to the conclusion of our
+Added: Board that he should serve as a director of our Company in light of our business and structure.
+Added: Board has undertaken a review of the independence of our directors and has determined that (i) all current directors, except Mr.
+Added: Todisco, our Chief Executive Officer, are independent
+Added: within the meaning of Section 5605(b) of the Nasdaq Marketplace Rules, (ii) all members of our Audit Committee meet the additional test
+Added: for independence for audit committee members imposed by SEC regulation and Section 5605(c) of the Nasdaq Marketplace Rules, (iii) all
+Added: of the members of our Compensation Committee are independent within the meaning of Section 5605(d) of the Nasdaq Marketplace Rules, and
+Added: (iv) all of the members of our Nominating and Governance Committee, except Mr.
+Added: Todisco, our Chief Executive Officer, are independent within the meaning of Section 5605(e) of the Nasdaq
+Added: Marketplace Rules.
+Added: Board has established an Audit Committee, a Compensation Committee and a Nominating and Governance Committee.
+Added: Our Audit Committee currently
+Added: consists of Mr.
+Added: Lefkowitz (Chair), Dr.
Dunton and Mr.
Our Compensation Committee currently consists of Ms.
−Removed: Dillione (Chair), Dr.
+Added: Dillione (Chair),
Dunton and Mr.
1 unchanged sentence
Costa (Chair), Mr.
−Removed: Kaplan and Ms.
−Removed: The membership
−Removed: of these Committees may be changed after our next annual meeting.
−Removed: Each of the above-referenced committees operates
−Removed: pursuant to a formal written charter.
−Removed: The charters for each committee, which have been adopted by our Board, contain a detailed description
−Removed: of the respective committee’s duties and responsibilities and are available on our website at www.cormedix.com under the “Investor
−Removed: Relations—Corporate Governance” tab.
−Removed: Audit Committee
−Removed: The Audit Committee monitors our corporate financial
−Removed: statements and reporting and our external audits, including, among other things, our internal controls and audit functions, the results
−Removed: and scope of the annual audit and other services provided by our independent registered public accounting firm and our compliance with
−Removed: legal matters that have a significant impact on our financial statements.
−Removed: The Audit Committee also consults with our management and our
−Removed: independent registered public accounting firm prior to the presentation of financial statements to stockholders and, as appropriate,
−Removed: initiates inquiries into aspects of our financial affairs.
−Removed: The Audit Committee is responsible for establishing procedures for the receipt,
−Removed: retention and treatment of complaints regarding accounting, internal accounting controls or auditing matters, and for the confidential,
−Removed: anonymous submission by our employees of concerns regarding questionable accounting or auditing matters.
−Removed: In addition, the Audit Committee
−Removed: is directly responsible for the appointment, retention, compensation and oversight of the work of our independent registered public accounting
−Removed: firm, including approving services and fee arrangements.
−Removed: All related party transactions will be approved by the Audit Committee before
−Removed: we enter into them.
−Removed: Both our independent registered public accounting
−Removed: firm and internal financial personnel regularly meet with, and have unrestricted access to, the Audit Committee.
−Removed: The Board has determined that each of Mr.
+Added: The membership of these Committees may be changed after our next annual meeting.
+Added: of the above-referenced committees operates pursuant to a formal written charter.
+Added: The charters for each committee, which have been adopted
+Added: by our Board, contain a detailed description of the respective committee’s duties and responsibilities and are available on our
+Added: website at www.cormedix.com under the “Investor Relations—Corporate Governance” tab.
+Added: Audit Committee monitors our corporate financial statements and reporting and our external audits, including, among other things, our
+Added: internal controls and audit functions, the results and scope of the annual audit and other services provided by our independent registered
+Added: public accounting firm and our compliance with legal matters that have a significant impact on our financial statements.
+Added: The Audit Committee
+Added: also consults with our management and our independent registered public accounting firm prior to the presentation of financial statements
+Added: to stockholders and, as appropriate, initiates inquiries into aspects of our financial affairs.
+Added: The Audit Committee is responsible for
+Added: establishing procedures for the receipt, retention and treatment of complaints regarding accounting, internal accounting controls or
+Added: auditing matters, and for the confidential, anonymous submission by our employees of concerns regarding questionable accounting or auditing
+Added: In addition, the Audit Committee is directly responsible for the appointment, retention, compensation and oversight of the work
+Added: of our independent registered public accounting firm, including approving services and fee arrangements.
+Added: All related party transactions
+Added: will be approved by the Audit Committee before we enter into them.
+Added: our independent registered public accounting firm and internal financial personnel regularly meet with, and have unrestricted access
+Added: to, the Audit Committee.
+Added: Board has determined that each of Mr.
+Added: Lefkowitz, Dr.
Dunton and Mr.
−Removed: Duncan qualifies as an “audit committee financial expert” as that term is defined in the rules
−Removed: and regulations of the SEC.
+Added: Duncan qualifies as an “audit committee financial expert”
+Added: as that term is defined in the rules and regulations of the SEC.
The designation of each of Mr.
1 unchanged sentence
Dunton and Mr.
−Removed: Duncan as an “audit
−Removed: committee financial expert” does not impose on them any duties, obligations or liability that are greater than those that are generally
−Removed: imposed on them as a member of the Audit Committee and the Board, and their designation as an “audit committee financial expert”
−Removed: pursuant to this SEC requirement does not affect the duties, obligations or liability of any other member of the Audit Committee or the
−Removed: Compensation Committee
−Removed: The Compensation Committee reviews and approves
−Removed: our compensation policies and all forms of compensation to be provided to our executive officers, including, among other things, annual
−Removed: salaries, bonuses, and other incentive compensation arrangements.
−Removed: In addition, the Compensation Committee administers our equity compensation
−Removed: plans, including granting stock options to our executive officers.
−Removed: The Compensation Committee also reviews and approves employment agreements
−Removed: with executive officers and other compensation policies and matters.
−Removed: Since 2016, we have periodically engaged Frederic
−Removed: Cook & Co., an independent compensation consultant, for input on the compensation of our Named Executive Officers and
+Added: as an “audit committee financial expert” does not impose on them any duties, obligations or liability that are greater than
+Added: those that are generally imposed on them as a member of the Audit Committee and the Board, and their designation as an “audit committee
+Added: financial expert” pursuant to this SEC requirement does not affect the duties, obligations or liability of any other member of
+Added: the Audit Committee or the Board.
+Added: Compensation Committee reviews and approves our compensation policies and all forms of compensation to be provided to our executive officers,
+Added: including, among other things, annual salaries, bonuses, and other incentive compensation arrangements.
+Added: In addition, the Compensation
+Added: Committee administers our equity compensation plans, including granting stock options to our executive officers.
+Added: The Compensation Committee
+Added: also reviews and approves employment agreements with executive officers and other compensation policies and matters.
+Added: 2016, we have periodically engaged Frederic W.
+Added: Cook & Co., an independent compensation consultant, for input on the compensation
+Added: of our Named Executive Officers and directors.
The Compensation Committee assessed the independence of Frederic W.
−Removed: Cook & Co., considering the factors required
−Removed: by the Nasdaq Global Market Listing Rules and concluded that no conflict of interest exists that would prevent Frederic W.
+Added: Cook & Co., considering
+Added: the factors required by the Nasdaq Global Market Listing Rules and concluded that no conflict of interest exists that would prevent Frederic
from independently representing our Company.
−Removed: In the future, we, or the Compensation Committee, may engage or seek the advice of Frederic
+Added: In the future, we, or the Compensation Committee, may engage or seek the
+Added: advice of Frederic W.
Cook & Co., or another compensation consultant.
−Removed: At our 2021 annual meeting of stockholders, our
−Removed: stockholders indicated their preference that we solicit a non-binding advisory vote on the compensation of the named executive officers,
−Removed: commonly referred to as a “Say-On-Pay” vote, every year.
−Removed: This vote is not intended to address any specific item of compensation,
−Removed: but rather the overall compensation of our named executive officers and the philosophy, policies and practices described in this Annual
−Removed: Report on Form 10-K.
−Removed: The Compensation Committee evaluates our executive compensation program in light of our benchmarking of peer companies
−Removed: with the advice of Frederic W.
−Removed: Cook as well as our shareholders’ views’ including the “Say-On-Pay” votes when
−Removed: making future decisions regarding executive compensation.
−Removed: The next “Say-On-Pay” vote will occur at the 2022 annual meeting
−Removed: of stockholders.
−Removed: Each member of the Compensation Committee is a
−Removed: non-employee director, as defined pursuant to Rule 16b-3 promulgated under the Exchange Act.
−Removed: Nominating and Governance Committee
−Removed: The Nominating and Governance Committee identifies,
−Removed: evaluates and recommends nominees to the Board and committees of the Board, conducts searches for appropriate directors and evaluates
−Removed: the performance of the Board and of individual directors.
−Removed: The Nominating and Governance Committee also is responsible for reviewing developments
−Removed: in corporate governance practices, evaluating the adequacy of our corporate governance practices and reporting and making recommendations
−Removed: to the Board concerning corporate governance matters.
−Removed: Executive Officers
+Added: our 2021 annual meeting of stockholders, our stockholders indicated their preference that we solicit a non-binding advisory vote on the
+Added: compensation of the named executive officers, commonly referred to as a “Say-On-Pay” vote, every year.
+Added: This vote is not intended
+Added: to address any specific item of compensation, but rather the overall compensation of our named executive officers and the philosophy,
+Added: policies and practices described in this Annual Report on Form 10-K.
+Added: The Compensation Committee evaluates our executive compensation
+Added: program in light of our benchmarking of peer companies with the advice of Frederic W.
+Added: Cook as well as our shareholders’ views’
+Added: including the “Say-On-Pay” votes when making future decisions regarding executive compensation.
+Added: We solicited a “Say-On-Pay
+Added: vote at our 2022 annual meeting of stockholders, and the next “Say-On-Pay” vote will occur at the 2023 annual meeting of
+Added: stockholders.
+Added: member of the Compensation Committee is a non-employee director, as defined pursuant to Rule 16b-3 promulgated under the Exchange Act.
+Added: and Governance Committee
+Added: Nominating and Governance Committee identifies, evaluates and recommends nominees to the Board and committees of the Board, conducts
+Added: searches for appropriate directors and evaluates the performance of the Board and of individual directors.
+Added: The Nominating and Governance
+Added: Committee also is responsible for reviewing developments in corporate governance practices, evaluating the adequacy of our corporate
+Added: governance practices and reporting and making recommendations to the Board concerning corporate governance matters.
The following table sets forth the name, age and
−Removed: position of each of our executive officers as of December 31, 2021:
+Added: position of each of our executive officers as of March 15, 2023:
Position(s) with CorMedix
+Added: Joseph Todisco
+Added: Chief Executive Officer
Matthew David
−Removed: Interim Chief Executive Officer, Chief Financial Officer
+Added: Chief Financial Officer
Phoebe Mounts
Executive Vice President and General Counsel and Head of Regulatory, Compliance and Legal
−Removed: Elizabeth Masson-Hurlburt
+Added: Elizabeth Hurlburt
Executive Vice President and Head of Clinical Operations
−Removed: Thomas Nusbickel
Executive Vice President and Chief Commercial Officer
−Removed: Matthew David became our Executive
−Removed: Vice President and Chief Financial Officer in May 2020 and is currently serving as interim Chief Executive Officer since the retirement
−Removed: Baluch on October 4, 2021.
−Removed: Prior to joining us, he most recently served as Head of Strategy at Ovid Therapeutics Inc,
−Removed: a late-stage clinical biopharmaceutical company focused on developing treatments for rare neurological disorders, where he was responsible
−Removed: for financing strategy and investor relations, and joined in October 2018.
−Removed: Prior to Ovid, Dr.
−Removed: David was a Strategic Advisor
−Removed: to Frequency Therapeutics, advising on financing, investor relations and strategic initiatives from 2017 to early 2019.
−Removed: Prior to Frequency,
−Removed: David spent the majority of his career as an investment banker specialized in the life sciences sectors, including at Piper Jaffray,
−Removed: Thomas Weisel Partners, Ferghana Partners and most recently at Bank of America Merrill Lynch.
−Removed: As part of his experience as an investment
+Added: the biography for Joseph Todisco under “Directors.”
+Added: David became our Chief Financial Officer in May 2020.
+Added: From October 4, 2021 through May 10, 2022, Dr.
+Added: David also served as
+Added: our interim Chief Executive Officer in addition to his role as Chief Financial Officer.
+Added: Prior to joining us, he most recently served
+Added: as Head of Strategy at Ovid Therapeutics Inc, a late-stage clinical biopharmaceutical company focused on developing treatments for rare
+Added: neurological disorders, where he was responsible for financing strategy and investor relations, and joined in October 2018.
+Added: David was a Strategic Advisor to Frequency Therapeutics, advising on financing, investor relations and strategic initiatives
+Added: from 2017 to early 2019.
+Added: Prior to Frequency, Dr.
+Added: David spent the majority of his career as an investment banker specialized in the life
+Added: sciences sectors, including at Piper Jaffray, Thomas Weisel Partners, Ferghana Partners and most recently at Bank of America Merrill
+Added: As part of his experience as an investment banker, Dr.
David has advised on a broad range of capital raising and strategic transactions.
Earlier in his career, Dr.
−Removed: was part of the equity research team at Lehman Brothers, focusing on Large Pharma.
−Removed: David began his career as a surgical resident
−Removed: at Beth Israel Hospital, after receiving an M.D.
+Added: David was part of the equity research team at Lehman Brothers, focusing on Large Pharma.
+Added: David began his
+Added: career as a surgical resident at Beth Israel Hospital, after receiving an M.D.
from NYU School of Medicine.
−Removed: David earned his Bachelor of Arts degree in Chemistry,
−Removed: magna cum laude , from Dartmouth College.
−Removed: Phoebe Mounts became our Executive
−Removed: Vice President and General Counsel and Head of Regulatory, Compliance and Legal in May 2019.
+Added: David earned his Bachelor
+Added: of Arts degree in Chemistry, magna cum laude, from Dartmouth College.
+Added: Mounts became our Executive Vice President and General Counsel and Head of Regulatory, Compliance and Legal in May 2019 and Technical
+Added: Operations in October 2021.
Prior to her employment with us, Dr.
−Removed: was a partner at Morgan, Lewis & Bockius LLP, where she provided legal counsel to life sciences companies for over 20 years.
+Added: Mounts was a partner at Morgan, Lewis & Bockius LLP, where she provided
+Added: legal counsel to life sciences companies for over 20 years.
As part of her work at Morgan Lewis, Dr.
−Removed: Mounts had been providing us legal services as outside counsel since 2013, with responsibility
−Removed: for developing our FDA regulatory strategies for DefenCath.
−Removed: Prior to graduating from Georgetown University Law Center, Dr.
−Removed: was on the faculty of the Johns Hopkins University School of Public Health for 16 years, specializing in molecular biology and infectious
+Added: Mounts had been providing us legal
+Added: services as outside counsel since 2013, with responsibility for developing our FDA regulatory strategies for DefenCath.
+Added: Prior to graduating
+Added: from Georgetown University Law Center, Dr.
+Added: Mounts was on the faculty of the Johns Hopkins University School of Public Health for 16 years,
+Added: specializing in molecular biology and infectious disease.
She received her Ph.D.
−Removed: in molecular biology from the University of Edinburgh in Scotland.
−Removed: Elizabeth Masson-Hurlburt became
+Added: in molecular biology from the University of Edinburgh
+Added: Elizabeth Hurlburt became
our Executive Vice President and Head of Clinical Operations in March 2018.
+Added: Her current role is Executive Vice President and Head of
+Added: Clinical and Medical Affairs, effective May 2022.
Prior to her employment, Ms.
−Removed: Masson-Hurlburt had been providing
−Removed: us clinical operations expertise as a consultant since late November 2017.
−Removed: Before she began her consulting career, she held several progressive
−Removed: management roles in clinical operations, most recently at Gemphire Therapeutics, as a Senior Director, Clinical Operations from April
−Removed: 2015 to October 2016, then as Vice President, Clinical Operations from October 2016 to March 2018.
−Removed: Masson-Hurlburt received her B.A.
−Removed: in Leadership and Organizational Management from Bay Path College.
−Removed: Thomas Nusbickel became our Executive
−Removed: Vice President and Chief Commercial Officer in May 2021.
−Removed: Prior to his employment, Mr.
−Removed: Nusbickel held several leadership roles
−Removed: in the commercial strategy and renal disease space, most recently at Coherus Biosciences, as Vice President of Market Access and Government
−Removed: Affairs, Opko Inc., as Chief Commercial Officer, and served for more than two decades at Amgen.
−Removed: Nusbickel has an undergraduate
−Removed: degree from Eckerd College and an M.B.A.
−Removed: from Pepperdine University.
−Removed: On October 1, 2021, the Company and Khoso
−Removed: Baluch came to a mutual agreement pursuant to which Mr.
−Removed: Baluch retired from his position as our Chief Executive Officer, effective
−Removed: October 4, 2021.
−Removed: Baluch also resigned from our Board of Directors.
−Removed: David is serving as interim Chief Executive Officer
−Removed: and Chief Financial Officer.
−Removed: The Board of Directors appointed Joseph Todisco as the Chief Executive Officer on March 16, 2022, commencing
−Removed: no later than May 16, 2022, and appointed Mr.
−Removed: Todisco to serve as a member of the Board on March 18, 2022.
−Removed: David will continue to
−Removed: serve as interim Chief Executive Officer and Chief Financial Officer until Mr.
−Removed: Todisco commences employment, after which Dr.
−Removed: continue to serve as our Chief Financial Officer.
−Removed: On October 4, 2021, we and John L.
−Removed: came to a mutual agreement pursuant to which Mr.
−Removed: Armstrong retired from his position as our Executive Vice President, Technical
−Removed: Operations, effective October 4, 2021.
+Added: Hurlburt had been providing us clinical operations expertise
+Added: as a consultant since late November 2017.
+Added: Before she began her consulting career, she held several progressive management roles in clinical
+Added: operations, most recently at Gemphire Therapeutics, as a Senior Director, Clinical Operations from April 2015 to October 2016, then as
+Added: Vice President, Clinical Operations from October 2016 to March 2018.
+Added: Hurlburt received her B.A.
+Added: in Leadership and Organizational
+Added: Management from Bay Path College and a M.S.
+Added: in Management and Leadership from Western Governors University.
+Added: Erin Mistry became our Senior Vice
+Added: President of Payer Strategy, Government Affairs and Trade in March 2020.
+Added: Her current role is Executive Vice President and Chief Commercial
+Added: Officer, effective January 2023.
+Added: Prior to joining CorMedix, Erin held roles as VP market access at Intarcia therapeutics as well as Senior
+Added: Managing Director of the global Value and Access practice at Syneos Health.
+Added: During her career, Erin has worked with emerging, mid-size,
+Added: and large biopharma companies with a focus on pricing, access and reimbursement.
+Added: She currently serves on the boards of Incubate Coalition
+Added: and the AntiMicrobial Working Group, both in Washington, DC.
+Added: Erin holds a B.S.
+Added: in Industrial Engineering (healthcare) and an M.S.
+Added: in Biomechanical
+Added: Engineering from North Carolina State University.
+Added: On May 10, 2022, Thomas Nusbickel, our former Chief
+Added: Commercial Officer, and CorMedix mutually agreed to part ways, effective June 1, 2022.
Executive Compensation
−Removed: DIRECTOR COMPENSATION
−Removed: Director Compensation in Fiscal 2021
−Removed: The following table shows the compensation earned
−Removed: by each non-employee director of our Company for the year ended December 31, 2021.
+Added: Compensation in Fiscal 2022
+Added: following table shows the compensation earned by each non-employee director of our Company for the year ended December 31, 2022:
Awards (1) (2)
2 unchanged sentences
Steven Lefkowitz
−Removed: The amounts included in this column are the dollar amounts representing the full grant date fair value of each stock option award calculated in accordance with FASB ASC Topic 718 and do not represent the actual value that may be recognized by the directors upon option exercise.
−Removed: For information on the valuation assumptions used in calculating these amounts, see Note 7 to our audited financial statements included in this Annual Report on Form 10-K.
−Removed: (2) As of December 31, 2021, the number of shares underlying
−Removed: options held by each non-employee director was as follows:
+Added: (1) The amounts included in this
+Added: column are the dollar amounts representing the full grant date fair value of each stock option award calculated in accordance with
+Added: FASB ASC Topic 718 and do not represent the actual value that may be recognized by the directors upon option exercise.
+Added: information on the valuation assumptions used in calculating these amounts, see Note 9 to our audited financial statements included
+Added: in this Annual Report on Form 10-K.
+Added: of December 31, 2022, the number of shares underlying options held by each non-employee director was as follows:
63,750 shares for Mr.
2 unchanged sentences
92,500 shares for Dr.
−Removed: 86,000 shares
−Removed: and 83,000 shares for Mr.
−Removed: Director Compensation Plan
−Removed: We maintain a Deferred Compensation Plan for Directors,
−Removed: pursuant to which our non-employee directors may defer all of their cash director fees and restricted stock units.
−Removed: Any cash fees due to
−Removed: a participating director will be converted into a number of shares of our common stock by dividing the dollar amount of fees payable by
−Removed: the closing price of our common stock on the date such fees would be payable, and the director’s unfunded account is credited with
−Removed: The shares that accumulate in a director’s account will be paid to the director on the tenth business day in January
−Removed: following the year in which the director’s service terminates for whatever reason, other than death, in which case the account will
−Removed: be paid within 30 days of the date of death to the designated beneficiary, as applicable.
−Removed: In the event of a change in control of
−Removed: our Company, the director would receive cash in an amount equal to the number of shares in the account multiplied by the fair market value
−Removed: of our common stock on the change in control date, and the payment would be accelerated to five business days after the effective
−Removed: date of the change in control.
−Removed: In January 2021, the Board, following the recommendation
−Removed: of the Compensation Committee and based on advice of Frederic W.
−Removed: Cook & Co., determined that no adjustment was needed with regard
−Removed: to Board and committee cash compensation.
−Removed: Following a review of board compensation practices of the Company’s peer group, the Board
−Removed: made the following changes to equity compensation effective as of January 2021, (i) increased the annual grant of stock options to each
−Removed: non-employee director from 15,000 to 20,000 shares, (ii) increased the initial grant of stock options to new non-employee directors from
−Removed: 20,000 to 25,000 shares;
−Removed: and (iii) provided a one-time 10,000 share grant of stock options as of January 11, 2021 for non-employee directors
−Removed: who joined the Board prior to 2020.
−Removed: The 2020 and 2021 compensation programs are set forth below in the
+Added: 106,000 shares for Mr.
+Added: shares for Mr.
+Added: Compensation Plan
+Added: Board, following the recommendation of the Compensation Committee and, based on advice of Frederic W.
+Added: Cook & Co., determined that
+Added: no adjustment was needed with regard to Board and committee cash compensation for 2022.
+Added: 2022 compensation program is set forth below in the table.
+Added: Each year we make an annual grant of stock options to each non-employee director
+Added: with respect to 20,000 shares and we make an initial grant of stock options to new non-employee directors with respect to 25,000 shares,
+Added: prorated as appropriate.
All stock options are subject to continued service on the Board through the vesting date.
−Removed: The exercise price per share of each
−Removed: stock option granted to our non-employee directors is equal to the fair market value of our common stock as determined based upon the
−Removed: closing sales price for our stock on the date of grant.
−Removed: On January 11, 2021, our Board amended outstanding
−Removed: stock options to purchase shares of our common stock held by the non-employee directors to extend the post-termination exercise period
−Removed: of such options such that each vested stock option held by a director as of the date of separation from service will remain exercisable
−Removed: for the 12-month period following the date of separation from service, but in no event later than the end of the term of the option.
−Removed: Effective January 1,
−Removed: Effective January 1,
+Added: The exercise price
+Added: per share of each stock option granted to our non-employee directors is equal to the fair market value of our common stock as determined
+Added: based upon the closing sales price for our stock on the date of grant.
First Election to Board
8 unchanged sentences
Additional Annual Fee - Strategic Committee Members
−Removed: Additional Annual Fee – Strategic Finance Committee Two Co-Chairs
−Removed: (1) Vest one third each on the date
−Removed: of grant and the first and second anniversary date of grant.
−Removed: Vest monthly over one year after the grant date.
−Removed: (3) The Additional Annual Fee for the
−Removed: Strategic Finance Committee Co-Chairs ended on June 30, 2020.
−Removed: EXECUTIVE COMPENSATION
−Removed: Components of Compensation
+Added: Additional One-Time Fee - Search Committee for CEO
+Added: one third each on the date of grant and the first and second anniversary date of grant.
+Added: monthly over one year after the grant date.
+Added: additional one-time fee for the Search Committee for CEO was paid in Q2 2022.
+Added: maintain a Deferred Compensation Plan for Directors, pursuant to which our non-employee directors may defer all of their cash director
+Added: fees and restricted stock units.
+Added: Any cash fees due to a participating director will be converted into a number of shares of our common
+Added: stock by dividing the dollar amount of fees payable by the closing price of our common stock on the date such fees would be payable,
+Added: and the director’s unfunded account is credited with the shares.
+Added: The shares that accumulate in a director’s account will
+Added: be paid to the director on the tenth business day in January following the year in which the director’s service terminates for
+Added: whatever reason, other than death, in which case the account will be paid within 30 days of the date of death to the designated beneficiary,
+Added: as applicable.
+Added: In the event of a change in control of our Company, the director would receive cash in an amount equal to the number of
+Added: shares in the account multiplied by the fair market value of our common stock on the change in control date, and the payment would be
+Added: accelerated to five business days after the effective date of the change in control.
+Added: of Compensation
The key components of our executive compensation
3 unchanged sentences
Executive Officers.
−Removed: During 2021, our Named Executive Officers were Khoso Baluch, Matthew David, John Armstrong, Phoebe
−Removed: Mounts, Elizabeth Masson-Hurlburt and Thomas Nusbickel.
−Removed: Baluch retired as our Chief Executive Officer effective October 4,
−Removed: 2021, and Mr.
−Removed: Armstrong retired as our Executive Vice President for Technical Operations effective October 4, 2021.
−Removed: who has served as our Executive Vice President and Chief Financial Officer since May 11, 2020, has from October 4, 2021, also
−Removed: served as our interim Chief Executive Officer in addition to his role as Chief Financial Officer.
−Removed: It is the Compensation Committee’s objective
−Removed: to set a competitive rate of annual base salary for each Named Executive Officer.
−Removed: The Compensation Committee believes competitive base
−Removed: salaries are necessary to attract and retain top quality executives, since it is common practice for public companies to provide their
−Removed: named executive officers with a guaranteed annual component of compensation that is not subject to performance risk.
−Removed: The Compensation
−Removed: Committee, on its own or with outside consultants, may establish salary ranges for the Named Executive Officers, with minimum to maximum
−Removed: opportunities that cover the normal range of market variability.
−Removed: The actual base salary for each Named Executive Officer is then derived
−Removed: from those salary ranges based on his or her responsibility, tenure and past performance and market comparability.
−Removed: Annual base salaries
−Removed: for the Named Executive Officers are reviewed and approved by the Compensation Committee in the first quarter following the end of the
−Removed: previous performance year.
−Removed: Changes in base salary are based on the scope of an individual’s current job responsibilities, individual
−Removed: performance in the previous performance year, target pay position relative to the peer group, and our salary budget guidelines.
−Removed: The Compensation
−Removed: Committee reviews established goals and objectives, and determines an individual’s achievement of those goals and objectives and
−Removed: considers the recommendations provided by the Chief Executive Officer to assist it in determining appropriate salaries for the Named Executive
−Removed: Officers other than the Chief Executive Officer.
−Removed: For the years ended December 31, 2020 and
−Removed: 2021, with the advice of outside consultants, including Frederic W.
−Removed: Cook & Co., the Compensation Committee increased the
−Removed: salaries of certain of our Named Executive Officers to account for adjustments in the market.
−Removed: See under the caption “Employment
−Removed: In May 2020, March 2019, March 2021
−Removed: and May 2021, respectively, we entered into an employment agreement with each of Matthew David, our Executive Vice President and Chief
−Removed: Financial Officer, Phoebe Mounts, our Executive Vice President and General Counsel and Head of Regulatory, Compliance and Legal, Elizabeth
−Removed: Masson-Hurlburt, our Executive Vice President and Head of Clinical Operations, and Thomas Nusbickel, our Chief Commercial Officer.
−Removed: agreements provide for a salary for each Named Executive Officer and are described under the caption “Employment Agreements.”
−Removed: Effective October 4, 2021, Matthew David,
−Removed: our Chief Financial Officer, began serving as interim Chief Executive Officer, until a new Chief Executive Officer is appointed.
−Removed: new base salary as an interim Chief Executive Officer is described under the caption “Employment Agreements.” Dr.
−Removed: new base salary was increased to account for the additional responsibilities associated with serving as interim Chief Executive Officer.
−Removed: David’s new base salary was increased from $330,000 to $425,000 to account for the additional responsibilities associated with
−Removed: serving as the interim Chief Executive Officer.
−Removed: David continue to serve as the interim Chief Executive for six months after
−Removed: October 4, 2021, the Board, or its Compensation Committee, will review such base salary to determine whether an increase is appropriate
−Removed: at that time.
−Removed: David ceases to serve as interim Chief Executive Officer, and as he continues to serve as Chief Financial Officer,
−Removed: we will provide him with an annual base salary of $375,000, representing a $45,000 increase from his current salary level under the employment
−Removed: The base salary information for our Named Executive
−Removed: Officers for 2020 and 2021 is set forth in the Summary Compensation Table below.
−Removed: Annual Bonuses
−Removed: As part of their compensation package, our Named
−Removed: Executive Officers generally have the opportunity to earn annual non-equity incentive bonuses.
+Added: During 2022, our Named Executive Officers were Joseph Todisco, Matthew David, Phoebe Mounts, Elizabeth Hurlburt and
+Added: Thomas Nusbickel.
+Added: Todisco’s service as our Chief Executive Officer was effective May 10, 2022.
+Added: Nusbickel separated from
+Added: service as our Chief Commercial Officer effective June 1, 2022.
+Added: is the Compensation Committee’s objective to set a competitive rate of annual base salary for each Named Executive Officer.
+Added: Compensation Committee believes competitive base salaries are necessary to attract and retain top quality executives, since it is common
+Added: practice for public companies to provide their named executive officers with a guaranteed annual component of compensation that is not
+Added: subject to performance risk.
+Added: The Compensation Committee, on its own or with outside consultants, may establish salary ranges for the
+Added: Named Executive Officers, with minimum to maximum opportunities that cover the normal range of market variability.
+Added: The actual base salary
+Added: for each Named Executive Officer is then derived from those salary ranges based on his or her responsibility, tenure and past performance
+Added: and market comparability.
+Added: Annual base salaries for the Named Executive Officers are reviewed and approved by the Compensation Committee
+Added: in the first quarter following the end of the previous performance year.
+Added: Changes in base salary are based on the scope of an individual’s
+Added: current job responsibilities, individual performance in the previous performance year, target pay position relative to the peer group,
+Added: and our salary budget guidelines.
+Added: The Compensation Committee reviews established goals and objectives, and determines an individual’s
+Added: achievement of those goals and objectives and considers the recommendations provided by the Chief Executive Officer to assist it in determining
+Added: appropriate salaries for the Named Executive Officers other than the Chief Executive Officer.
+Added: the years ended December 31, 2022 and 2021, with the advice of outside consultants, including Frederic W.
+Added: the Compensation Committee increased the salaries of certain of our Named Executive Officers to account for adjustments in the market.
+Added: See under the caption “Employment Agreements.”
+Added: March 2019, May 2020, March 2021 and March 2022, respectively, we entered into an employment agreement with each of Phoebe Mounts, our
+Added: Executive Vice President and General Counsel and Head of Regulatory, Compliance and Legal, Matthew David, our Executive Vice President
+Added: and Chief Financial Officer, Elizabeth Hurlburt, our Executive Vice President and Head of Clinical Operations, and Joseph Todisco, our
+Added: Chief Executive Officer.
+Added: These agreements provide for a salary for each Named Executive Officer and are described under the caption “Employment
+Added: David, our Chief Financial Officer, served as interim Chief Executive Officer until Mr.
+Added: Todisco was appointed Chief Executive Officer,
+Added: effective May 10, 2022.
+Added: David’s base salary was increased from $330,000 to $425,000 to account for the additional responsibilities
+Added: associated with serving as the interim Chief Executive Officer.
+Added: His compensation as the interim Chief Executive Officer is described
+Added: under the caption “Employment Agreements.” Following Dr.
+Added: David’s tenure as the interim Chief Executive Officer, and
+Added: as he continues to serve as Chief Financial Officer, his annual base salary was $375,000.
+Added: March 16, 2022, we entered into an employment agreement with Mr.
+Added: Todisco to serve as our Chief Executive Officer, effective May 10, 2022.
+Added: base salary information for our Named Executive Officers for 2022 is described under the caption “Employment Agreements.”
+Added: maintain the CorMedix Inc.
+Added: Executive Bonus Plan (the “Bonus Plan”), which is used to grant annual and other performance bonuses
+Added: to executives, including our Named Executive Officers.
+Added: The Bonus Plan provides for bonuses based on achievement of performance objectives,
+Added: as determined by the Compensation Committee for each performance period.
+Added: As part of their compensation package, our Named Executive Officers
+Added: generally have the opportunity to earn annual non-equity incentive bonuses under the Bonus Plan.
Annual non-equity bonuses are designed
to reward superior executive performance while reinforcing our short-term strategic operating goals.
−Removed: The Board approves, based on
−Removed: the Compensation Committee’s recommendation, an annual corporate target award for the Named Executive Officers based on a percentage
+Added: The Board approves, based on the
+Added: Compensation Committee’s recommendation, an annual corporate target award for the Named Executive Officers based on a percentage
of base salary and any applicable terms in any individual employment agreements.
1 unchanged sentence
with executive rank so that for the more senior executives, a greater proportion of their total cash compensation is contingent upon annual
−Removed: For 2021, Messrs.
−Removed: Baluch and Armstrong, Dr.
−Removed: Masson-Hurlburt and Mr.
−Removed: Nusbickel were each eligible for
−Removed: an annual target bonus of 80%, 35%, 30%, 30% and 30% of base salary, respectively, of his or her base salary then in effect.
−Removed: was eligible for an annual target bonus of 30% of base salary prior to serving as interim Chief Executive Officer and the target was increased
−Removed: to 60% of base salary while serving in that role.
−Removed: David’s new annual target bonus as interim Chief Executive Officer is described
−Removed: under the caption “Employment Agreements.”
−Removed: On December 20, 2021, the Board adopted the
−Removed: CorMedix Inc.
−Removed: Executive Bonus Plan (the “Bonus Plan”), which will be used to grant annual and other performance bonuses to
−Removed: executives, including our Named Executive Officers.
−Removed: The Bonus Plan provides for bonuses based on achievement of performance objectives,
−Removed: as determined by the Compensation Committee for each performance period.
−Removed: Participants may receive bonuses based on a target
−Removed: bonus amount, which may be a percentage of the participant’s base salary or such other amount as the Compensation Committee determines,
−Removed: and achievement of the applicable performance objectives.
−Removed: Bonuses are subject to continued employment through the end of the applicable
−Removed: performance period and compliance with restrictive covenant agreements.
−Removed: The Compensation Committee will set the performance periods, target
−Removed: bonuses and performance objectives and will select the eligible executives for each performance period.
−Removed: The performance metrics may include
−Removed: (but shall not be limited to) any of the following:
−Removed: (i) net earnings or net income (before or after taxes);
−Removed: (ii) earnings per share;
−Removed: net sales growth;
−Removed: (iv) net operating profit;
−Removed: (v) return measures (including, but not limited to, return on assets, capital, equity, or
−Removed: (vi) cash flow (including, but not limited to, operating cash flow, free cash flow, and cash flow return on capital);
−Removed: flow per share;
−Removed: (viii) earnings before or after taxes, interest, depreciation, and/or amortization;
−Removed: (ix) gross or operating margins;
−Removed: productivity ratios;
−Removed: (xi) share price (including, but not limited to, growth measures and total stockholder return);
−Removed: (xii) expense targets
−Removed: (xiii) charge-off levels;
−Removed: (xiv) improvement in or attainment of revenue levels;
−Removed: (xv) margins;
−Removed: (xvi) operating efficiency;
−Removed: operating expenses;
−Removed: (xviii) economic value added;
−Removed: (xix) improvement in or attainment of expense levels;
−Removed: (xx) improvement in or attainment
−Removed: of working capital levels;
−Removed: (xxi) debt reduction;
−Removed: (xxii) capital targets;
−Removed: (xxiii) regulatory, clinical, or manufacturing milestones;
−Removed: consummation of acquisitions, dispositions, projects or other events or transactions;
−Removed: (xxv) developing strategic plans, (xxvi) objectives
−Removed: related to product development, testing, product design, regulatory approval, product manufacturing and other business needs, and (xxvii)
−Removed: personal objectives for the participant.
−Removed: Bonuses are to be paid in a cash lump sum within 2 ½ months following the end of the applicable
−Removed: performance period (but no later than March 15 of the calendar year following the calendar year in which the performance period ends).
−Removed: Effective as of the inception of the Bonus Plan,
−Removed: the Compensation Committee approved a special performance bonus opportunity under the Bonus Plan for Dr.
−Removed: Matthew David, interim Chief
−Removed: Executive Officer, Executive Vice President and Chief Financial Officer, Dr.
−Removed: Phoebe Mounts, Executive Vice President and General Counsel,
−Removed: Liz Masson-Hurlburt, Executive Vice President and Head of Clinical Operations, to provide an incentive for the Company’s
−Removed: leadership team to accomplish specific performance objectives during a performance period beginning October 1, 2021 and ending March 31,
−Removed: The executives have an opportunity to earn a performance bonus of up to 30% of salary for Dr.
−Removed: Mounts and Ms.
−Removed: Masson-Hurlburt and
−Removed: up to 60% of salary for Dr.
−Removed: David based on attainment of key performance objectives, continued employment and compliance with restrictive
−Removed: With new leadership under Dr.
−Removed: David as interim Chief Executive Officer, the Compensation Committee determined that it was appropriate
−Removed: to provide specific targeted performance objectives tied to incentive payments to drive performance that is intended to support our long-term
+Added: For 2022, Dr.
+Added: Hurlburt and Mr.
+Added: Nusbickel were each eligible for an annual target bonus of 30% each of their respective
+Added: base salary then in effect.
+Added: David was eligible for an annual target bonus of 30% of base salary prior to serving as interim Chief
+Added: Executive Officer and the target was increased to 60% of base salary while serving in that role.
+Added: Following Dr.
+Added: David’s tenure as
+Added: the interim Chief Executive Officer, and as he continues to serve as Chief Financial Officer, his current annual target bonus is 40%.
+Added: Todisco joined the Company on May 10, 2022 and his bonus is described in more detail under the caption “Employment Agreements.”
At the beginning of the performance year, the Board
6 unchanged sentences
measure of how the Named Executive Officer contributed to business results.
−Removed: The Compensation Committee determined that it was
−Removed: appropriate to pay discretionary bonuses to Dr.
−Removed: Masson-Hurlburt and Mr.
−Removed: Nusbickel based on individual performance
−Removed: and the challenges the Company had faced during 2021.
−Removed: Masson-Hurlburt and Mr.
−Removed: Nusbickel received discretionary
−Removed: bonuses of $75,900, $61,875, $37,800 and $75,000, respectively.
−Removed: In 2021, we paid our Named Executive Officers annual
−Removed: bonuses equal to their target annual bonuses for 2020, and we paid Dr.
+Added: For 2022, the Compensation Committee determined that it was
+Added: appropriate to pay bonuses to Mr.
+Added: David and Ms.
+Added: Hurlburt based on achievement of corporate goals and individual
+Added: performance in 2022.
+Added: David and Ms.
+Added: Hurlburt received performance bonuses of $305,760, $88,200, $147,235
+Added: and $84,848, respectively.
+Added: In the case of Dr.
+Added: David, his bonus reflected his bonus targets as both the interim Chief Executive Officer
+Added: and Chief Financial Officer, on a prorated basis.
+Added: These bonuses were paid in early 2023.
+Added: Nusbickel received a bonus in accordance
+Added: with the terms of his separation agreement as described under “Employment Agreements” below.
+Added: 2021, the Compensation Committee approved a special performance bonus opportunity under the Bonus Plan for Dr.
+Added: Matthew David, then interim
+Added: Chief Executive Officer, Executive Vice President and Chief Financial Officer, Dr.
+Added: Phoebe Mounts, Executive Vice President and General
+Added: Counsel and Head of Technical Operations, and Ms.
+Added: Elizabeth Hurlburt, Executive Vice President and Head of Clinical Operations, to provide
+Added: an incentive for the Company’s leadership team to accomplish specific performance objectives during a performance period beginning
+Added: October 1, 2021 and ending March 31, 2022.
+Added: The executives had an opportunity to earn a performance bonus of up to 30% of salary for Dr.
Mounts and Ms.
−Removed: Masson-Hurlburt each a special bonus equal to two
−Removed: months of base salary on account of their work on the submission of the New Drug Application for DefenCath.
−Removed: The Board, based on the recommendation
−Removed: of the Compensation Committee, approved bonuses at these levels as a result of corporate and individual performance and the submission
−Removed: of the New Drug Application for DefenCath.
−Removed: Long-Term Incentive Equity Awards
−Removed: We believe that long-term performance is achieved
−Removed: through an ownership culture that encourages high performance by our Named Executive Officers through the use of stock-based awards.
−Removed: long-term incentive plans were established to provide our employees, including our Named Executive Officers, with incentives to help align
−Removed: employees’ interests with the interests of our stockholders.
−Removed: The Compensation Committee believes that the use of stock-based awards
−Removed: offers the best approach to achieving our long-term compensation goals.
−Removed: We have historically elected to use stock options as the primary
−Removed: long-term equity incentive vehicle;
−Removed: however, the Compensation Committee may in the future utilize other forms of equity grants as part
−Removed: of our long-term incentive program.
−Removed: We have selected the Black-Scholes method of valuation for share-based compensation.
−Removed: Due to the early
−Removed: stage of our business and our desire to preserve cash, we may provide a greater portion of total compensation to our Named Executive Officers
−Removed: through stock options and other equity grants than through cash-based compensation.
−Removed: The Compensation Committee generally oversees the
−Removed: administration of our equity plans.
−Removed: Stock Options
−Removed: Our 2019 Omnibus Stock Incentive Plan (the 2019
−Removed: Plan), which was approved by the shareholders on November 26, 2019, authorizes us to grant options to purchase shares of our common
−Removed: stock and other equity awards to our employees, directors and consultants.
−Removed: The Compensation Committee or the Board, based
−Removed: on Compensation Committee recommendations, makes stock option awards to Named Executive Officers based upon a review of competitive compensation
−Removed: data, its assessment of individual performance, a review of each Named Executive Officer’s existing long-term incentives, and retention
−Removed: considerations.
−Removed: Periodic stock option grants are made, or recommended to the Board, at the discretion of the Compensation Committee to
−Removed: eligible employees and, in appropriate circumstances, the Compensation Committee considers the recommendations of our Chief Executive
+Added: Hurlburt and up to 60% of salary for Dr.
+Added: David based on attainment of key performance objectives, continued employment
+Added: and compliance with restrictive covenants.
+Added: With new leadership while Dr.
+Added: David served as interim Chief Executive Officer, the Compensation
+Added: Committee determined that it was appropriate to provide specific targeted performance objectives tied to incentive payments to drive
+Added: performance that is intended to support our long-term performance.
+Added: In May 2022, Dr.
+Added: Mounts and Ms.
+Added: Hurlburt received performance
+Added: bonuses of $242,250, $106,875 and $89,775, respectively.
+Added: Incentive Equity Awards
+Added: believe that long-term performance is achieved through an ownership culture that encourages high performance by our Named Executive Officers
+Added: through the use of stock-based awards.
+Added: Our long-term incentive plans were established to provide our employees, including our Named Executive
+Added: Officers, with incentives to help align employees’ interests with the interests of our stockholders.
+Added: The Compensation Committee
+Added: believes that the use of stock-based awards offers the best approach to achieving our long-term compensation goals.
+Added: We have historically
+Added: elected to use stock options as the primary long-term equity incentive vehicle;
+Added: however, the Compensation Committee may in the future
+Added: utilize other forms of equity grants as part of our long-term incentive program.
+Added: We have selected the Black-Scholes method of valuation
+Added: for share-based compensation.
+Added: Due to the early stage of our business and our desire to preserve cash, we may provide a greater portion
+Added: of total compensation to our Named Executive Officers through stock options and other equity grants than through cash-based compensation.
+Added: The Compensation Committee generally oversees the administration of our equity plans.
+Added: On October 13, 2022, our shareholders approved the Amended and Restated
+Added: 2019 Omnibus Stock Incentive Plan, which, subject to certain adjustments, authorizes us to issue up to 4,800,000 additional shares of
+Added: our common stock as long-term equity incentives to our employees, consultants and directors.
+Added: The long-term incentives may be in the form
+Added: of stock options, stock appreciation rights, restricted stock, restricted stock units, dividend equivalent rights, or other rights or
+Added: benefits to employees, consultants, and directors of our Company or a related entity.
+Added: Compensation Committee or the Board, based on Compensation Committee recommendations, makes stock option awards to Named Executive Officers
+Added: based upon a review of competitive compensation data, its assessment of individual performance, a review of each Named Executive Officer’s
+Added: existing long-term incentives, and retention considerations.
+Added: Periodic stock option grants are made, or recommended to the Board, at the
+Added: discretion of the Compensation Committee to eligible employees and, in appropriate circumstances, the Compensation Committee considers
+Added: the recommendations of our Chief Executive Officer.
Stock options granted to employees have an exercise
−Removed: price equal to the fair market value of our common stock on the day of grant, typically vest based on continued employment and,
−Removed: for performance-based grants, upon the achievement of certain performance-based milestones, and generally expire 10 years after
−Removed: the date of grant.
−Removed: The fair value of the options granted to the Named Executive Officers in the Summary Compensation Table is determined
−Removed: in accordance with the Black-Scholes method of valuation for share-based compensation.
−Removed: Incentive stock options also include certain other
−Removed: terms necessary to ensure compliance with the Code.
−Removed: In 2021, the Board, based on the recommendation
−Removed: of the Compensation Committee, granted a mix of time-based and performance-based stock options to our Named Executive Officers.
−Removed: The time-based
−Removed: stock options vest annually in four increments while the executive remains employed by the Company.
−Removed: The performance-based stock options
−Removed: generally vest based upon achievement of performance milestones and continued employment.
−Removed: In January 2021, the Board granted 70,000 time-based
−Removed: stock options to Dr.
−Removed: Armstrong, and Ms.
−Removed: Masson-Hurlburt, respectively, 40,000 time-based stock options to Dr.
−Removed: David, and 160,000
−Removed: time-based stock options to Mr.
−Removed: Baluch, and granted the same number of performance-based stock options to each, respectively.
−Removed: In November 2021, the Board, based on the recommendation
−Removed: of the Compensation Committee, granted additional stock options to Drs.
−Removed: David and Mounts, in order to recognize their increased responsibilities,
−Removed: including assuming the additional obligations associated with the interim Chief Executive Director role in the case of Dr.
−Removed: overseeing the Company’s technical operations group, in the case of Dr.
−Removed: David was granted a stock option with respect
−Removed: to 125,000 shares of our common stock and Dr.
−Removed: Mounts was granted a stock option with respect to 100,000 shares of our common stock, both
−Removed: with an exercise price of $5.56 per share, which was the closing price of our common stock on the Nasdaq Global Market on the date of
−Removed: The options will vest over four years in four equal annual installments beginning on the date of grant, subject to Drs.
−Removed: Mounts’ continued employment, consistent with the terms of our standard form of option agreement.
−Removed: In February 2021, the Compensation Committee
−Removed: amended outstanding time-based stock options held by our Named Executive Officers to extend the post-termination exercise periods with
−Removed: respect to such stock options that are vested as of the date of termination of employment:
−Removed: (i) from 90 days to 12 months
−Removed: following the date of termination in the event of an involuntary termination without Cause, a termination for Good Reason, death or disability
−Removed: and (ii) by implementing a new three-year post-termination exercise period following the date of termination of employment in the
−Removed: event of a termination by reason of retirement (i.e., termination after reaching age 62 with five years of continuous service or
−Removed: age 55 with ten years of continuous service), but not beyond the date of expiration of the term of the option in either case.
−Removed: amendment did not apply to outstanding incentive stock option so as to not affect their tax status.
−Removed: We expect to continue to use stock options as
−Removed: a long-term incentive vehicle because:
−Removed: ● Stock options align the interests of our Named Executive Officers
−Removed: with those of our stockholders, supporting a pay-for performance culture, foster employee stock ownership, and focus the management team
−Removed: on increasing value for our stockholders.
−Removed: Stock options are performance-based.
+Added: price equal to the fair market value of our common stock on the day of grant, typically vest based on continued employment and, for performance-based
+Added: grants, upon the achievement of certain performance-based milestones, and generally expire 10 years after the date of grant.
+Added: value of the options granted to the Named Executive Officers in the Summary Compensation Table is determined in accordance with the Black-Scholes
+Added: method of valuation for share-based compensation.
+Added: Incentive stock options also include certain other terms necessary to ensure compliance
+Added: with the Code.
+Added: In February 2023, the Board, based on the recommendation
+Added: of the Compensation Committee, granted time-based stock options to our Named Executive Officers based on 2022 metrics as determined by
+Added: The time-based stock options vest annually in four increments while the executive remains employed by the Company.
+Added: granted 125,000 time-based stock options each to Dr.
+Added: Mounts and Ms.
+Added: Hurlburt, all with an exercise price of $4.43 per share,
+Added: and 400,000 time-based stock options to Mr.
+Added: Todisco with an exercise price of $4.43 per share.
+Added: January 2021, the Board, based on the recommendation of the Compensation Committee, granted a mix of time-based and performance-based
+Added: stock options to Drs.
+Added: Mounts and David, Messrs.
+Added: Armstrong and Baluch, and Ms.
+Added: Hurlburt, which vested annually in four increments while
+Added: the executive remained employed by the Company.
+Added: These performance-based stock options were forfeited in December 2022 because the performance
+Added: was not achieved and, in the case of Messrs.
+Added: Armstrong and Baluch, they no longer remained employed by us.
+Added: expect to continue to use stock options as a long-term incentive vehicle because:
+Added: options align the interests of our Named Executive Officers with those of our stockholders, supporting a pay-for-performance culture,
+Added: foster employee stock ownership, and focus the management team on increasing value for our stockholders.
+Added: options are performance-based.
All of the value received by the recipient of a stock option is based on the growth of the stock price.
In addition, stock options can be issued with vesting based on the achievement of performance goals.
−Removed: ● Stock options help to provide balance to the overall executive
−Removed: compensation program as base salary and annual bonuses focus on short-term compensation, while the vesting of stock options increases
−Removed: stockholder value over the longer term.
−Removed: ● The vesting period of stock options encourages executive retention
−Removed: and the preservation of stockholder value.
−Removed: In determining the number of stock options to be granted to our Named Executive Officers,
−Removed: we take into account the individual’s position, scope of responsibility, ability to affect profits and stockholder value and the
−Removed: individual’s historic and recent performance and the value of stock options in relation to other elements of the individual Named
−Removed: Executive Officer’s total compensation.
−Removed: Executive Benefits and Perquisites
−Removed: Our Named Executive Officers are parties to employment
−Removed: agreements as described below.
−Removed: In addition, consistent with our compensation philosophy, we intend to continue to maintain our current
−Removed: benefits for our Named Executive Officers, including medical, dental and life insurance and the ability to contribute to a 401(k) plan;
−Removed: however, the Compensation Committee in its discretion may revise, amend, or add to the officer’s executive benefits if it deems
−Removed: it advisable.
−Removed: We believe these benefits are currently comparable to benefit levels for comparable companies.
−Removed: Employment Agreements
−Removed: Employment Agreements with Current Named Executive Officers
−Removed: On September 26, 2019, we entered into an
−Removed: employment agreement with Mr.
−Removed: Baluch, our former Chief Executive Officer.
−Removed: In connection with Mr.
−Removed: Baluch’s separation from service
−Removed: on October 4, 2021, we and Mr.
−Removed: Baluch entered into a separation agreement and release dated as of October 1, 2021 (the “Baluch
−Removed: Separation Agreement”).
−Removed: Baluch’s retirement was treated as a termination without Cause (as defined below) under the
−Removed: employment agreement, based on the circumstances of his retirement.
−Removed: Under the Baluch Separation Agreement, Mr.
−Removed: Baluch received the
−Removed: severance payments and benefits described in his employment agreement as follows:
−Removed: (i) lump sum payment of 60 days compensation, payment
−Removed: of any accrued compensation and any unpaid bonus for the prior year, as well as rights to indemnification and directors’ and officers’
−Removed: liability insurance and any rights or privilege otherwise required by law;
−Removed: (ii) payment of base salary for a period of 12 months following
−Removed: October 4, 2021;
−Removed: (iii) payment on a prorated basis, if any, for the 2021 year, based on the actual achievement of the specified bonus
−Removed: Baluch elected to continue health insurance coverage under COBRA, monthly payment of a portion of his COBRA premium
−Removed: for a period of 12 months following October 4, 2021 or until he became eligible for group health insurance coverage under another employer’s
−Removed: plan, whichever occurs first;
−Removed: and (v) all equity awards and stock options that are scheduled to vest on or before the next succeeding
−Removed: anniversary of the date of termination shall be accelerated and deemed to have vested as of the termination date, provided that any performance-based
−Removed: equity awards and stock options whose vesting requirements have not been successfully met as of the date of termination will not accelerate.
−Removed: Baluch met the eligibility requirements for retirement as of the date of his separation, so certain of Mr.
−Removed: vested stock options will be exercisable for up to three years after the date of his separation under the terms of the applicable
−Removed: grant agreements.
−Removed: The Baluch Separation Agreement provides this retirement treatment for all of Mr.
−Removed: Baluch’s outstanding vested
−Removed: We reimbursed Mr.
−Removed: Baluch for reasonable legal fees up to $20,000 incurred in connection with the review of the Baluch Separation
−Removed: Baluch is bound by confidentiality, non-solicitation and non-competition covenants under his employment agreement,
−Removed: and an extended covenant not to solicit employees under the Baluch Separation Agreement, among other terms.
−Removed: On April 17, 2020, we entered into an employment
−Removed: agreement with Mr.
−Removed: Armstrong, our former Executive Vice President for Technical Operations.
−Removed: In connection with Mr.
−Removed: Armstrong’s separation from service on October 4, 2021, we and Mr.
−Removed: Armstrong entered into a separation agreement and release
−Removed: dated as of October 4, 2021 (the “Armstrong Separation Agreement”).
−Removed: Armstrong’s retirement was treated
−Removed: as a termination without Cause under the employment agreement, based on the circumstances of his requirement.
−Removed: Under the Armstrong Separation
−Removed: Agreement, Mr.
−Removed: Armstrong received the severance payments and benefits described in his employment agreement are as follows:
−Removed: sum payment of 60 days compensation, payment of any accrued compensation and any unpaid bonus for the prior year, as well as rights to
−Removed: indemnification and directors’ and officers’ liability insurance and any rights or privilege otherwise required by law;
−Removed: payment of base salary for a period of nine months following October 4, 2021;
−Removed: (iii) payment on a prorated basis, if any, for the 2021
−Removed: year, based on the actual achievement of the specified bonus objectives;
−Removed: Armstrong elected to continue health insurance coverage
−Removed: under COBRA, then monthly payment of a portion of his COBRA premium for a period of nine months following October 4, 2021 or until he
−Removed: became eligible for group health insurance coverage under another employer’s plan, whichever occurs first;
−Removed: and (v) all equity awards
−Removed: and stock options that are scheduled to vest on or before the next succeeding anniversary of the date of termination shall be accelerated
−Removed: and deemed to have vested as of the termination date, provided that any performance-based equity awards and stock options whose vesting
−Removed: requirements have not been successfully met as of the date of termination will not accelerate.
−Removed: Armstrong met the eligibility
−Removed: requirements for retirement as of the date of his separation, so certain of Mr.
−Removed: Armstrong’s vested stock options will be exercisable
−Removed: for up to three years after the date of his separation under the terms of the applicable grant agreements.
−Removed: The Armstrong Separation
−Removed: Agreement provides this retirement treatment for all outstanding vested options.
−Removed: We reimbursed Mr.
−Removed: Armstrong for reasonable legal
−Removed: fees up to $10,000 incurred in connection with the review of the Armstrong Separation Agreement.
−Removed: Armstrong is bound by confidentiality,
−Removed: non-solicitation and non-competition covenants under his employment agreement, and an extended covenant not to solicit employees under
−Removed: the Armstrong Separation Agreement, among other terms.
−Removed: On March 10, 2021, we entered into a new employment
−Removed: agreement with Ms.
−Removed: Masson-Hurlburt to serve as our Executive Vice President and Head of Clinical Operations.
−Removed: 2019, we entered into an employment agreement with Dr.
−Removed: Mounts to serve as our Executive Vice President and General Counsel and Head of
−Removed: Regulatory, Compliance and Legal, effective May 1, 2019.
−Removed: On April 29, 2021, we entered into an employment agreement with Mr.
−Removed: to serve as our Executive Vice President and Chief Commercial Officer, effective May 13, 2021.
+Added: options help to provide balance to the overall executive compensation program as base salary and annual bonuses focus on short-term compensation,
+Added: while the vesting of stock options increases stockholder value over the longer term.
+Added: vesting period of stock options encourages executive retention and the preservation of stockholder value.
+Added: In determining the number of
+Added: stock options to be granted to our Named Executive Officers, we take into account the individual’s position, scope of responsibility,
+Added: ability to affect profits and stockholder value, the individual’s historic and recent performance and the value of stock options
+Added: in relation to other elements of the individual Named Executive Officer’s total compensation.
+Added: Benefits and Perquisites
+Added: Named Executive Officers are parties to employment agreements as described below.
+Added: In addition, consistent with our compensation philosophy,
+Added: we intend to continue to maintain our current benefits for our Named Executive Officers, including medical, dental and life insurance
+Added: and the ability to contribute to a 401(k) plan;
+Added: however, the Compensation Committee in its discretion may revise, amend, or add
+Added: to the officer’s executive benefits if it deems it advisable.
+Added: We believe these benefits are currently comparable to benefit levels
+Added: for comparable companies.
+Added: Agreements with Current Named Executive Officers
+Added: March 16, 2022, we entered into an employment agreement with Mr.
+Added: Todisco, our Chief Executive Officer.
+Added: After the initial term, the term
+Added: of the employment agreement will automatically renew for additional successive one-year periods, unless either party notifies the other
+Added: in writing at least 90 days before the expiration of the then-current term that the term will not be renewed.
+Added: The terms of Mr.
+Added: employment agreement are further described below.
+Added: May 11, 2020, we entered into an employment agreement with Dr.
+Added: David to serve as our Chief Financial Officer.
After the initial three-year
−Removed: term of each employment agreement, the term of the employment agreement will automatically renew for additional successive one-year periods,
+Added: term of the employment agreement, the term of the employment agreement will automatically renew for additional successive one-year periods,
unless either party notifies the other in writing at least 90 days before the expiration of the then-current term that the term will
not be renewed.
−Removed: On May 11, 2020, we entered into an employment
−Removed: agreement with Dr.
−Removed: David to serve as our Chief Financial Officer.
−Removed: After the initial three-year term of the employment agreement, the term
−Removed: of the employment agreement will automatically renew for additional successive one-year periods, unless either party notifies the other
−Removed: in writing at least 90 days before the expiration of the then-current term that the term will not be renewed.
−Removed: On October 26, 2021,
−Removed: we entered into a letter agreement with Dr.
−Removed: David which modified certain terms of his employment agreement and provided other compensation
−Removed: as a result of Dr.
−Removed: David serving as our interim Chief Executive Officer effective as of October 4, 2021.
−Removed: Pursuant to the letter agreement,
−Removed: during the period in which Dr.
−Removed: David serves as interim Chief Executive Officer, his base salary was increased to $425,000 from $330,000,
−Removed: which is the amount set forth in his employment agreement.
−Removed: David continue to serve as the interim Chief Executive Officer for
−Removed: six months after October 4, 2021, the Board or Compensation Committee will review such base salary to determine whether an increase is
−Removed: appropriate at that time.
−Removed: David ceases to serve as interim Chief Executive Officer, and as he continues to serve as Chief Financial
−Removed: Officer, we will provide him with an annual base salary of $375,000, representing a $45,000 increase from his current salary level under
−Removed: the employment agreement.
−Removed: The Board or Compensation Committee will review such base salary to determine whether an increase is appropriate
−Removed: in 2022 as part of the 2022 compensation review cycle and benchmarking review.
+Added: October 26, 2021, we entered into a letter agreement with Dr.
+Added: David which modified certain terms of his employment agreement, dated as
+Added: of May 11, 2020, and provided other compensation as a result of Dr.
+Added: David serving as our interim Chief Executive Officer, effective as
+Added: of October 4, 2021 through May 10, 2022.
+Added: Pursuant to the letter agreement, during the period in which Dr.
+Added: David served as interim Chief
+Added: Executive Officer, his base salary was increased to $425,000 from $330,000, which is the amount set forth in his employment agreement.
+Added: David ceased to serve as interim Chief Executive Officer and while he serves as Chief Financial Officer, he receives an annual
+Added: base salary of $375,000, effective May 10, 2022.
Under the letter agreement, Dr.
−Removed: David’s target annual
−Removed: bonus with respect to the period during which he serves as interim Chief Executive Officer is increased to 60% from 30% of his base salary.
−Removed: David ceases to serve as interim Chief Executive Officer, and as he continues to serve as Chief Financial Officer, his target
−Removed: annual bonus will increase to 40% of his base salary.
−Removed: Under the letter agreement, in the event Dr.
−Removed: David’s employment is terminated
−Removed: by us other than as a result of his death or disability or notice of nonrenewal of the employment agreement, and other than for Cause,
−Removed: or if he resigns for Good Reason, in either case during the period he serves as interim Chief Executive Officer, he will be eligible for
−Removed: severance equal to his base salary for a period of 12 months following his termination date, which is increased from nine months as is
−Removed: otherwise provided for in his employment agreement.
−Removed: David has agreed to waive any rights he may have under his employment agreement
−Removed: to a Good Reason termination as a result of his ceasing to serve as our interim Chief Executive Officer at a future date.
−Removed: In connection
−Removed: David serving as interim Chief Executive Officer, the Board granted Dr.
−Removed: David a stock option with respect to 125,000 shares of
−Removed: our common stock with an exercise price of $5.56 per share, which was the closing price of our common stock on the Nasdaq Global Market
−Removed: on the date of grant.
−Removed: The option will vest over four years in four equal annual installments beginning on the date of grant, subject to
−Removed: David’s continued employment, consistent with the terms of our standard form of option agreement.
−Removed: Pursuant to their respective employment agreements,
−Removed: Baluch received an annual salary of $425,000, Mr.
−Removed: Armstrong received an annual salary of $325,000, Ms.
−Removed: Masson-Hurlburt
−Removed: receives an annual salary of $315,000 (effective March 2021), Dr.
−Removed: Mounts receives an annual salary of $350,000 (amended to $375,000
−Removed: in January 2021), Mr.
−Removed: Nusbickel receives and annual salary of $375,000 and Dr.
−Removed: David receives an annual salary of $330,000 (amended
−Removed: to $425,000 while he serves as interim Chief Executive Officer).
−Removed: Such salaries cannot be decreased unless all officers and/or members
−Removed: of our executive management team experience an equal or greater percentage reduction in base salary and/or total compensation, provided
−Removed: that any reduction in an executive’s salary may be no greater than 25%.
−Removed: Baluch and Armstrong were eligible for an annual
−Removed: bonus, of up to 80% of his base salary for Mr.
−Removed: Baluch (the target amount is 80%, but the bonus could exceed that amount) and up to
−Removed: 35% of his base salary for Mr.
−Removed: Armstrong, as determined by our Board or the Compensation Committee.
−Removed: Each other executive will be
−Removed: eligible for an annual bonus of up to 30% for Ms.
−Removed: Masson-Hurlburt, up to 30% for Dr.
−Removed: Mounts, up to 30% for Mr.
−Removed: Nusbickel and up to
−Removed: David (and up to 60% while he serves as interim Chief Executive Officer), of his or her base salary then in effect, as
−Removed: determined by our Board or the Compensation Committee.
−Removed: In determining such bonus payment, our Board or the Compensation Committee will
−Removed: take into consideration the achievement of specified Company objectives, predetermined by our Board or the Compensation Committee and
−Removed: Chief Executive Officer, and such other factors as our Board or the Compensation Committee deems appropriate.
−Removed: Each executive generally
−Removed: must be employed through December 31 of a given year to be eligible to earn that year’s annual bonus.
−Removed: The following provisions of the employment
−Removed: agreements with Dr.
−Removed: Masson-Hurlburt and Messrs.
−Removed: Nusbickel, Baluch and Armstrong are identical except where noted.
−Removed: If we terminate the executive’s employment
−Removed: for Cause, the executive will be entitled to receive only the accrued compensation due to him or her as of the date of such
−Removed: termination, rights to indemnification and directors’ and officers’ liability insurance, and as otherwise required by
−Removed: law, and certain equity awards will be forfeited.
−Removed: If we terminate the executive’s
−Removed: employment other than for Cause, and other than for death, disability or notice of nonrenewal, or if the executive resigns for Good Reason
−Removed: (as defined below), the executive will receive the following benefits:
−Removed: (i) payment of any accrued compensation and any unpaid bonus
−Removed: relating to the completed prior year, as well as rights to indemnification and directors’ and officers’ liability insurance
−Removed: and any rights or privilege otherwise required by law;
−Removed: (ii) we will continue to pay the executive’s base salary for a
−Removed: period of twelve months in the case of Mr.
−Removed: Baluch, and in the case of Dr.
−Removed: David while he is serving as interim Chief Executive
−Removed: Officer, following termination of employment and nine months for the other executives, and for Dr.
−Removed: David while he is not serving
−Removed: as interim Chief Executive Officer, following termination of employment;
−Removed: (iii) payment on a prorated basis for any target bonus for
−Removed: the year of termination based on the actual achievement of the specified bonus objectives;
−Removed: (iv) if the executive timely elects continued
−Removed: health insurance coverage under COBRA, then we will pay the premium to continue such coverage for him or her and his or her eligible dependents
−Removed: in an amount equal to the portion paid for by us during the executive’s employment until the conclusion of the time when he
−Removed: or she is receiving continuation of base salary payments or until he or she becomes eligible for group health insurance coverage under
−Removed: another employer’s plan, whichever occurs first, provided however that we have the right to terminate such payment of COBRA premiums
−Removed: on behalf of the executive and instead pay him or her a lump sum amount equal to the COBRA premium times the number of months remaining
−Removed: in the specified period if we determine in our discretion that continued payment of the COBRA premiums is or may be discriminatory under
−Removed: Section 105(h) of the Code;
−Removed: and (v) unvested equity awards that are scheduled to vest on or before the next succeeding
−Removed: anniversary of the date of termination shall be accelerated and deemed to have vested as of the termination date;
−Removed: provided that any performance
−Removed: based equity awards or stock options whose vesting requirements have not been successfully met as of the date of termination of employment
−Removed: or resignation with Good Reason will not accelerate.
−Removed: In addition, the event of a termination by the Company without Cause or the executive’s
−Removed: resignation of employment for Good Reason, in either case within 24 months following a Corporate Transaction (as defined in the employment
−Removed: agreement), all equity awards and stock options shall become fully vested and exercisable, and vested stock options will remain exercisable
−Removed: for a specified period of time following termination or resignation or, if earlier, the expiration date of the stock option.
−Removed: The separation
−Removed: benefits set forth above are conditioned upon the executive executing a release of claims against us, our parents, subsidiaries, and affiliates,
−Removed: and each such entities’ officers, directors, employees, agents, successors, and assigns in a form acceptable to us, within a time
−Removed: specified therein, which release is not revoked within any time period allowed for revocation under applicable law.
−Removed: For purposes of the agreement, “Cause”
−Removed: is defined as:
−Removed: (i) the willful failure, disregard, or refusal by the executive to perform his or her material duties or obligations
−Removed: under the employment agreement (other than as a result of executive’s mental incapacity or illness;
−Removed: (ii) any willful, intentional,
−Removed: or grossly negligent act by the executive having the effect of materially injuring (whether financially or otherwise) our business or
−Removed: reputation or any of our affiliates;
−Removed: (iii) executive’s conviction of any felony involving moral turpitude (including entry
−Removed: of a guilty or nolo contendere plea);
−Removed: (iv) the executive’s qualification as a “bad actor,” as defined by 17 CFR
−Removed: (v) the good faith determination by the Board, after a reasonable and good-faith investigation by us that the executive
−Removed: engaged in some form of harassment or discrimination prohibited by law (including, without limitation, harassment on the basis of age,
−Removed: sex or race) unless the executive’s actions were specifically directed by the Board;
−Removed: (vi) any material misappropriation or
−Removed: embezzlement by the executive of our or our affiliates’ property (whether or not a misdemeanor or felony);
−Removed: or (vii) material
−Removed: breach by the executive of the employment agreement that is materially injurious to us and that is not cured, to the extent subject to
−Removed: cure, by executive to our reasonable satisfaction.
−Removed: For purposes of the agreement, “Good Reason”
−Removed: is defined as any of the following without the executive’s consent:
−Removed: (i) any material breach of the employment agreement by
−Removed: (ii) any material diminution by us of the executive’s duties, responsibilities, or authority;
−Removed: (iii) a material reduction
−Removed: in the executive’s annual base salary unless all officers and/or members of our executive management team experience
−Removed: an equal or greater percentage reduction in annual base salary and/or total compensation, provided that any reduction may be no
−Removed: greater than 25%;
−Removed: (iv) a material reduction in the executive’s target bonus level unless all officers and/or members of our
−Removed: executive management team experience an equal or greater percentage reduction related to target bonus levels, provided that any reduction
−Removed: may be no greater than 25%.
−Removed: If the executive terminates his or her
−Removed: employment by written notice of termination or if the executive or we terminate his or her employment by providing a notice of nonrenewal
−Removed: at least 90 days before the employment agreement is set to expire, the executive will not be entitled to receive any payments or
−Removed: benefits other than any accrued compensation, any unpaid prior year’s bonus, rights to indemnification and directors’
−Removed: and officers’ liability insurance and as otherwise required by law.
−Removed: If the executive’s employment is terminated
−Removed: as a result of his or her death or disability, we will pay the executive or the executive’s estate, as applicable, any accrued compensation
−Removed: and any unpaid prior year’s bonus.
−Removed: Our employment agreements with Dr.
−Removed: Masson-Hurlburt and Messrs.
−Removed: Nusbickel, Baluch and Armstrong each contain a non-compete provision that provides that during the employment
−Removed: and for a specified period immediately following the executive’s separation from employment for any reason, the executive is prohibited
−Removed: from engaging in any business involving the development or commercialization of a preventive anti-infective product that would be a direct
−Removed: competitor of Defencath/Neutrolin or a product containing taurolidine or any other product being actively developed or produced by us
−Removed: within the United States and the European Union (or in the case of Dr.
−Removed: Masson-Hurlburt and Mr.
−Removed: Nusbickel, worldwide)
−Removed: on the date of termination of his or her employment.
−Removed: Tax and Accounting Considerations
−Removed: federal income tax generally limits the
−Removed: tax deductibility of compensation we pay to our Named Executive Officers and certain other officers to $1.0 million each in the
−Removed: year the compensation becomes taxable to the executive officers.
−Removed: Although deductibility of compensation is preferred, tax deductibility
−Removed: is not a primary objective of our compensation programs.
−Removed: Rather, we seek to maintain flexibility in how we compensate our executive
−Removed: officers so as to meet a broader set of corporate and strategic goals and the needs of stockholders, and as such, we may be limited in
−Removed: our ability to deduct amounts of compensation from time to time.
−Removed: Accounting rules require us to expense the cost of our stock
−Removed: option grants.
−Removed: Because of option expensing and the impact of dilution on our stockholders, we pay close attention to, among other
−Removed: factors, the type of equity awards we grant and the number and value of the shares underlying such awards.
−Removed: Pension Benefits
−Removed: We do not maintain any qualified or nonqualified defined benefit pension
−Removed: As a result, none of our Named Executive Officers participate in or have benefits under qualified or nonqualified defined benefit
−Removed: pension plans sponsored by us.
−Removed: Our Compensation Committee may elect to adopt qualified or nonqualified pension benefit plans in the future
−Removed: if it determines that doing so is in our best interests.
−Removed: Nonqualified Deferred Compensation
−Removed: None of our Named Executive Officers participate in nonqualified defined
−Removed: contribution plans or other nonqualified deferred compensation plans maintained by us.
−Removed: Our Compensation Committee may elect to provide
−Removed: our officers and other employees with nonqualified deferred compensation benefits in the future if it determines that doing so is in our
−Removed: best interests.
−Removed: Summary Compensation Table
−Removed: The following table sets forth information with
−Removed: respect to compensation earned by our Named Executive Officers in the years ended December 31, 2021 and 2020:
+Added: David’s target annual bonus with respect to the
+Added: period during which he served as interim Chief Executive Officer was increased to 60% from 30% of his base salary.
+Added: to service as interim Chief Executive Officer, his target annual bonus is 40% of his base salary.
+Added: March 10, 2021, we entered into an employment agreement with Ms.
+Added: Hurlburt to serve as our Executive Vice President and Head of Clinical
+Added: After the initial three-year term of the employment agreement, the term of the employment agreement will automatically renew
+Added: for additional successive one-year periods, unless either party notifies the other in writing at least 90 days before the expiration
+Added: of the then-current term that the term will not be renewed.
+Added: March 19, 2019, we entered into an employment agreement with Dr.
+Added: Mounts to serve as our Executive Vice President and General Counsel
+Added: and Head of Regulatory, Compliance and Legal, effective May 19, 2019.
+Added: The term of the employment agreement will automatically renew for
+Added: additional successive one-year periods, unless either party notifies the other in writing at least 90 days before the expiration of the
+Added: then-current term that the term will not be renewed.
+Added: On April 29, 2021, we entered into an employment agreement with Mr.
+Added: Nusbickel, our Chief Commercial Officer.
+Added: In connection with Mr.
+Added: Nusbickel’s separation from service effective June 1, 2022, we and
+Added: Nusbickel entered into a separation agreement and release dated as of May 10, 2022 (the “Nusbickel Separation Agreement”).
+Added: Nusbickel was eligible to receive severance benefits on account of termination without Cause under the employment agreement.
+Added: the Nusbickel Separation Agreement, Mr.
+Added: Nusbickel received the severance payments and benefits described in his employment agreement as
+Added: (i) lump sum payment of 44 days compensation in lieu of notice;
+Added: (ii) payment of base salary for a period of nine months following
+Added: June 1, 2022;
+Added: (iii) payment of an annual bonus on a prorated basis, for the 2022 year, based on achievement of specified bonus objectives;
+Added: (iv) the monthly payment of a portion of his COBRA premium for a period of nine months following June 1, 2022 or until he became eligible
+Added: for group health insurance coverage under another employer’s plan, whichever occurs first;
+Added: and (v) all equity awards and stock options
+Added: that are scheduled to vest on or before the next succeeding anniversary of the date of termination shall be accelerated and deemed to
+Added: have vested as of the termination date, provided that any performance-based equity awards and stock options will not accelerate, as such
+Added: vesting requirements have not been successfully met as of the date of termination.
+Added: Nusbickel is bound by confidentiality, non-solicitation
+Added: and non-competition covenants under his employment agreement, among other terms.
+Added: to their respective employment agreements, Mr.
+Added: Todisco receives an annual salary of $600,000 (effective May 2022), Dr.
+Added: Mounts receives
+Added: an annual salary of $375,000, Dr.
+Added: David receives an annual salary of $375,000 (effective May 2022), and Ms.
+Added: Hurlburt receives an annual
+Added: salary of $365,000 (effective May 2022).
+Added: David’s salary was increased to $425,000 from October 2021 to May 2022 while he served
+Added: as interim Chief Executive Officer.
+Added: Such salaries cannot be decreased unless all officers and/or members of our executive management
+Added: team experience an equal or greater percentage reduction in base salary and/or total compensation, provided that any reduction in an
+Added: executive’s salary may be no greater than 25%.
+Added: Each executive is eligible for an annual bonus
+Added: of up to 30% for Ms.
+Added: Hurlburt, up to 30% for Dr.
+Added: Mounts, up to 40% for Dr.
+Added: David (which was increased up to 60% while he served as interim
+Added: Chief Executive Officer) and up to 65% for Mr.
+Added: Todisco (solely with respect to the 2022 fiscal year, Mr.
+Added: Todisco will receive an annual
+Added: bonus not less than $195,000), of his or her base salary then in effect, as determined by our Board or the Compensation Committee.
+Added: determining such bonus payment, our Board or the Compensation Committee will take into consideration the achievement of specified Company
+Added: objectives, predetermined by our Board or the Compensation Committee and Chief Executive Officer, and such other factors as our Board
+Added: or the Compensation Committee deems appropriate.
+Added: Each executive generally must be employed through December 31 of a given year to be eligible
+Added: to earn that year’s annual bonus.
+Added: The following provisions
+Added: of the employment agreements with Mr.
+Added: Todisco, Drs.
+Added: David and Mounts and Ms.
+Added: Hurlburt are identical except where noted.
+Added: we terminate the executive’s employment for Cause (as defined in the employment agreement), the executive will be entitled to receive
+Added: only the accrued compensation due to him or her as of the date of such termination, rights to indemnification and directors’ and
+Added: officers’ liability insurance, and as otherwise required by law, and certain equity awards will be forfeited.
+Added: we terminate the executive’s employment other than for Cause, and other than for death, disability or notice of nonrenewal, or
+Added: if the executive resigns for Good Reason (as defined in the employment agreement), the executive will receive the following benefits:
+Added: (i) payment of any accrued compensation and any unpaid bonus relating to the completed prior year, as well as rights to indemnification
+Added: and directors’ and officers’ liability insurance and any rights or privilege otherwise required by law;
+Added: (ii) we will continue
+Added: to pay the executive’s base salary for a period of twelve months in the case of Mr.
+Added: Todisco following termination of employment
+Added: and nine months for the other executives;
+Added: (iii) payment on a prorated basis for any target bonus for the year of termination based on
+Added: the actual achievement of the specified bonus objectives;
+Added: (iv) if the executive timely elects continued health insurance coverage under
+Added: COBRA, then we will pay the premium to continue such coverage for him or her and his or her eligible dependents in an amount equal to
+Added: the portion paid for by us during the executive’s employment until the conclusion of the time when he or she is receiving continuation
+Added: of base salary payments or until he or she becomes eligible for group health insurance coverage under another employer’s plan,
+Added: whichever occurs first, provided however that we have the right to terminate such payment of COBRA premiums on behalf of the executive
+Added: and instead pay him or her a lump sum amount equal to the COBRA premium times the number of months remaining in the specified period
+Added: if we determine in our discretion that continued payment of the COBRA premiums is or may be discriminatory under Section 105(h) of the
+Added: and (v) unvested equity awards that are scheduled to vest on or before the next succeeding anniversary of the date of termination
+Added: shall be accelerated and deemed to have vested as of the termination date, and in the case of Mr.
+Added: Todisco, accelerated vesting of the
+Added: restricted stock units granted to him on May 10, 2022;
+Added: provided that any performance based equity awards or stock options whose vesting
+Added: requirements have not been successfully met as of the date of termination of employment or resignation with Good Reason will not accelerate.
+Added: In addition, in the event of a termination by the Company without Cause or the executive’s resignation of employment for Good Reason,
+Added: in either case within 24 months following a Corporate Transaction (as defined in the employment agreement), all equity awards and stock
+Added: options shall become fully vested and exercisable, and vested stock options will remain exercisable for a specified period of time following
+Added: termination or resignation or, if earlier, the expiration date of the stock option, and, in the case of Mr.
+Added: Todisco, a payment in the
+Added: amount of 150% of the sum of Mr.
+Added: Todisco’s then-current base salary and his target bonus in effect will be paid in equal monthly
+Added: installments over 18 months following termination.
+Added: The separation benefits set forth above are conditioned upon the executive executing
+Added: a release of claims against us, our parents, subsidiaries, and affiliates, and each such entities’ officers, directors, employees,
+Added: agents, successors, and assigns in a form acceptable to us, within a time specified therein, which release is not revoked within any
+Added: time period allowed for revocation under applicable law.
+Added: the executive terminates his or her employment by written notice of termination or if the executive or we terminate his or her employment
+Added: by providing a notice of nonrenewal at least 90 days before the employment agreement is set to expire, the executive will not be entitled
+Added: to receive any payments or benefits other than any accrued compensation, any unpaid prior year’s bonus, rights to indemnification
+Added: and directors’ and officers’ liability insurance and as otherwise required by law.
+Added: the executive’s employment is terminated as a result of his or her death or disability, we will pay the executive or the executive’s
+Added: estate, as applicable, any accrued compensation and any unpaid prior year’s bonus.
+Added: employment agreements with Mr.
+Added: Todisco, Drs.
+Added: David and Mounts and Ms.
+Added: Hurlburt each contain a non-compete provision that provides that
+Added: during the employment and for a specified period immediately following the executive’s separation from employment for any reason,
+Added: the executive is prohibited from engaging in any business involving the development or commercialization of a preventive anti-infective
+Added: product that would be a direct competitor of DefenCath/Neutrolin or a product containing taurolidine or any other product being actively
+Added: developed or produced by us within the United States and the European Union (or in the case of Dr.
+Added: Todisco and Ms.
+Added: worldwide) on the date of termination of his or her employment.
+Added: and Accounting Considerations
+Added: federal income tax generally limits the tax deductibility of compensation we pay to our Named Executive Officers and certain other officers
+Added: to $1.0 million each in the year the compensation becomes taxable to the executive officers.
+Added: Although deductibility of compensation is
+Added: considered, tax deductibility is not a primary objective of our compensation programs.
+Added: Rather, we seek to maintain flexibility in how
+Added: we compensate our executive officers so as to meet a broader set of corporate and strategic goals and the needs of stockholders, and
+Added: as such, we may be limited in our ability to deduct amounts of compensation from time to time.
+Added: Accounting rules require us to expense
+Added: the cost of our stock option grants.
+Added: Because of option expensing and the impact of dilution on our stockholders, we pay close attention
+Added: to, among other factors, the type of equity awards we grant and the number and value of the shares underlying such awards.
+Added: do not maintain any qualified or nonqualified defined benefit pension plans.
+Added: As a result, none of our Named Executive Officers participate
+Added: in or have benefits under qualified or nonqualified defined benefit pension plans sponsored by us.
+Added: Our Compensation Committee may elect
+Added: to adopt qualified or nonqualified pension benefit plans in the future if it determines that doing so is in our best interests.
+Added: Deferred Compensation
+Added: of our Named Executive Officers participate in nonqualified defined contribution plans or other nonqualified deferred compensation plans
+Added: maintained by us.
+Added: Our Compensation Committee may elect to provide our officers and other employees with nonqualified deferred compensation
+Added: benefits in the future if it determines that doing so is in our best interests.
+Added: Compensation Table
+Added: following table sets forth information with respect to compensation earned by our Named Executive Officers in the years ended December
+Added: 31, 2022 and 2021:
Name and Principal Position
Incentive Plan
+Added: Compensa-tion
+Added: Compen-sation
+Added: Joseph Todisco (2)
+Added: Chief Executive Officer
Matthew David (5)
−Removed: Interim Chief Executive Officer and Chief Financial Officer
+Added: Chief Financial Officer
Phoebe Mounts
Executive Vice President and General Counsel and Head of Regulatory, Compliance and Legal
−Removed: Elizabeth Masson-Hurlburt
+Added: Elizabeth Hurlburt
Executive Vice President and Head of Clinical Operations
Thomas Nusbickel (10)
−Removed: Executive Vice President and Chief Commercial Officer
−Removed: Khoso Baluch (6)
−Removed: Former Chief Executive Officer
−Removed: John Armstrong (8)
−Removed: Former Executive Vice President for Technical Operations
−Removed: (1) The amounts included in this column are the dollar amounts representing
−Removed: the full grant date fair value of each award calculated in accordance with FASB ASC Topic 718 and do not represent the actual value that
−Removed: may be recognized by the Named Executive Officers upon option exercise.
−Removed: David became our Executive Vice President and Chief Financial
−Removed: Officer on May 11, 2020 and is also serves as the interim Chief Executive Officer
−Removed: effective October 4, 2021.
−Removed: Nusbickel became our Executive Vice President and Chief Commercial
−Removed: Officer on May 13, 2021.
−Removed: His salary does not include the sign-in bonus in cash amounting to $50,000, to be paid on the first anniversary
−Removed: of his employment, subject to his continued employment with us.
−Removed: (4) The non-equity incentive plan compensation are bonuses reflected in
−Removed: 2021 were for the performance for the year 2021 which were accrued in 2021 but will be paid in 2022.
−Removed: (5) Consists of health benefits and 401(k) employer match.
−Removed: (6) On October 1, 2021, the Company and Khoso Baluch came to a mutual agreement
−Removed: pursuant to which Mr.
−Removed: Baluch retired from his position as the Company’s Chief Executive Officer, effective October 4, 2021.
−Removed: awards include 240,000 options that were forfeited when he retired, with a grant date fair value of $1,196,240.
−Removed: Consists of health benefits, 401(k) employer match and severance pay
−Removed: of $495,833 of which $177,492 was paid in 2021 and the remaining balance of $318,341 will be paid in 2022.
−Removed: (8) On October 4,
−Removed: 2021, the Company and John Armstrong came to a mutual agreement pursuant to which Mr.
−Removed: Armstrong retired from his position as the
−Removed: Company’s Executive Vice President, Technical Operations, effective October 4, 2021.
−Removed: Option awards include 105,000 options
−Removed: that were forfeited when he retired, with a grant date fair value of $523,355.
−Removed: Consists of health benefits and severance pay of $297,917 of which
−Removed: $134,514 was paid in 2021 and the remaining balance of $163,403 will be paid in 2022.
−Removed: (10) Consists of health benefits, 401(k) employer match, and reimbursed
−Removed: commuter expenses
−Removed: (11) Consists of health benefits.
−Removed: Outstanding Equity Awards at Fiscal Year-End 2021
−Removed: The following table contains certain information
−Removed: concerning unexercised options for the Named Executive Officers as of December 31, 2021.
−Removed: Options (#) –
−Removed: Options (#) –
−Removed: Unexercisable (1)
−Removed: Incentive Plan
−Removed: Options # (2)
+Added: Former Executive Vice President and Chief Commercial Officer
+Added: The amounts included in this column are the dollar amounts representing the full grant date fair value of each award calculated in accordance with FASB ASC Topic 718 and do not represent the actual value that may be recognized by the Named Executive Officers upon option exercise.
+Added: Todisco became our Chief Executive Officer on May 10, 2022.
+Added: Represents annual bonus for the 2022 year that was accrued in fiscal year 2022 paid in 2023.
+Added: Represents premiums paid by us for health benefits and 401(k) plan employer match.
+Added: David served as the interim Chief Executive Officer effective October 4, 2021 through May 10, 2022.
+Added: Represents (i) an incentive cash award of $242,250, which was earned as a result of our performance during the period October 2021 through March 2022 and paid in 2022, under a special performance bonus opportunity, and (ii) $147,235 annual bonus for the 2022 year that was accrued in fiscal year 2022 and paid in 2023.
+Added: Solely with respect to (i) herein, $89,250 of the payment was accrued on an estimated basis during the year ended December 31, 2021 and the balance of $153,000 was booked during the year ended December 31, 2022.
+Added: Represents discretionary annual bonuses accrued in fiscal year 2021 paid in 2022.
+Added: Represents i) an incentive cash award of $106,875, which was earned as a result of our performance during the period October 2021 through March 2022 and paid in 2022, under a special performance bonus opportunity, and (ii) $88,200 annual bonus for the 2022 year that was accrued in fiscal year 2022 and paid in 2023.
+Added: Solely with respect to (i) herein, $39,375 of the payment was accrued on an estimated basis during the year ended December 31, 2021 and the balance of $67,500 was booked during the year ended December 31, 2022.
+Added: Represents (i) an incentive
+Added: cash award of $89,775, which was earned as a result of our performance during the period October 2021 through March 2022 and paid in
+Added: 2022, under a special performance bonus opportunity, and (ii) $85,848 annual bonus for the 2022 year that was accrued in fiscal
+Added: year 2022 and paid in 2023.
+Added: Solely with respect to (i) herein, $33,075 of the payment was accrued on an estimated basis during the
+Added: year ended December 31, 2021 and the balance of $56,700 was booked during the year ended December 31, 2022.
+Added: On May 10, 2022, we and Thomas Nusbickel came to a mutual agreement pursuant to which Mr.
+Added: Nusbickel separated from service as our Chief Commercial Officer, effective June 1, 2022.
+Added: Stock options granted in 2022 include 50,000 options that were forfeited when his employment was terminated, with a grant date fair value of $152,950.
+Added: Represents an annual bonus for the 2022 year paid in 2023.
+Added: Represents premiums paid by us for health benefits, 401(k) plan employer match, sign-on bonus in cash amounted to $50,000 and severance pay for Mr.
+Added: Nusbickel of $320,673 of which $251,215 was paid in 2022 and the remaining balance of $69,458 is payable in 2023.
+Added: Equity Awards at Fiscal Year-End 2022
+Added: following table contains certain information concerning unexercised options for the Named Executive Officers as of December 31, 2022.
+Added: Option Awards
+Added: Number of Shares Underlying Unexercised Options (#) Exercisable
+Added: Number of Shares Underlying Unexercised Options (#) Unexercisable (1)
+Added: Equity Incentive Plan Awards:
+Added: Number of Shares Underlying Unexercised Unearned Options # (2)
+Added: Option Exercise Price ($)
+Added: Option Expiration Date
+Added: Equity Incentive Plan Awards:
+Added: Number of Unearned Shares, Units or Other Rights That Have Not Vested (#)
+Added: Equity Incentive Plan Awards:
+Added: FMV or Payout Value of Unearned Shares, Units or Other Rights That Have Not Vested ($) (3)
+Added: Joseph Todisco
Matthew David
Phoebe Mounts
−Removed: Elizabeth Masson-Hurlburt
−Removed: Thomas Nusbickel
−Removed: John Armstrong
−Removed: (1) Options vest based on continued employment over three or four
−Removed: (2) Options vest based on achievement of specific milestones and continued
−Removed: employment and become exercisable if and when a milestone is achieved.
−Removed: Option Repricings
−Removed: We did not engage in any repricings or other modifications
−Removed: to any of our Named Executive Officers’ outstanding options during the year ended December 31, 2021.
−Removed: Potential Payments on a Qualifying Termination
−Removed: the severance payments called for in our employment agreements for Dr.
−Removed: Masson-Hurlburt and Mr.
−Removed: Nusbickel had been
−Removed: triggered on December 31, 2021, we would have been obligated to make the following payments:
+Added: Elizabeth Hurlburt
+Added: based on continued employment over four years.
+Added: vest based on achievement of specific milestones and continued employment and become exercisable if and when a milestone is achieved.
+Added: market value of the shares that could be acquired based on the closing sale price per share of our common stock on the Nasdaq Global
+Added: Market on December 31, 2022, which was $4.22.
+Added: restricted stock unit represents the right to receive one share of our common stock.
+Added: The restricted stock units vest 50%
+Added: on the first anniversary of the grant date, 30% on the second anniversary of the grant date, and the remaining 20% on the third anniversary
+Added: of the grant date, subject to continued service through the applicable vesting date.
+Added: did not engage in any repricings or other modifications to any of our Named Executive Officers’ outstanding options during the
+Added: year ended December 31, 2022.
+Added: Payments on a Qualifying Termination
+Added: the severance payments called for in our employment agreements for Mr.
+Added: Mounts and Ms.
+Added: Hurlburt had been triggered
+Added: on December 31, 2022, we would have been obligated to make the following payments:
Cash Severance
1 unchanged sentence
(# of months paid)
−Removed: Severance Benefits
−Removed: ($ per month) and
−Removed: (# of months paid) (1)
+Added: ($ per month)
+Added: and (# of months
Number of Options
−Removed: (# that would vest) and
+Added: (# that would vest)
($ market value) (2)
+Added: Restricted Stock
+Added: (# that would vest)
+Added: ($ market value) (3)
+Added: Joseph Todisco
Matthew David
Phoebe Mounts
−Removed: Elizabeth Masson-Hurlburt
−Removed: Thomas Nusbickel
+Added: Elizabeth Hurlburt
of COBRA payments.
−Removed: market value equals the difference between the fair market value of the shares that could
−Removed: be acquired based on the closing sale price per share of our common stock on the Nasdaq Global
−Removed: Market on December 31, 2021, which was $4.55, and the exercise prices of the applicable stock
−Removed: (3) Represents
−Removed: severance based on monthly base salary, payable for 12 months.
−Removed: Any bonus for the year of
−Removed: termination based on performance would also be paid.
−Removed: (4) Represents
−Removed: severance based on monthly base salary, payable for 9 months.
−Removed: Any bonus for the year of termination
−Removed: based on performance would also be paid.
−Removed: (5) Represents
−Removed: severance based on monthly base salary, payable for 9 months.
−Removed: Any bonus for the year of termination
−Removed: based on performance would also be paid.
+Added: market value equals the difference between the fair market value of the shares that could be acquired based on the closing sale price
+Added: per share of our common stock on the Nasdaq Global Market on December 31, 2022, which was $4.22, and the exercise prices of the applicable
+Added: stock options.
+Added: fair market value of the shares that could be acquired was based on the closing sale price per share of our common stock on the Nasdaq
+Added: Global Market on December 31, 2022, which was $4.22.
(4) Represents
severance based on monthly base salary, payable for 12 months.
−Removed: Any bonus for the year of termination
−Removed: based on performance would also be paid.
+Added: Any bonus for the year of termination based on performance would also
(5) Represents
severance based on monthly base salary, payable for 9 months.
−Removed: Any bonus for the year of termination
−Removed: based on performance would also be paid.
−Removed: The severance payments called for in the employment
−Removed: agreements with Messrs.
−Removed: Baluch and Armstrong were both triggered on October 4, 2021, and the Company was obligated to make the following
−Removed: payments pursuant to their respective separation agreements:
+Added: Any bonus for the year of termination based on performance would also be
+Added: severance payment called for in the employment agreement with Thomas Nusbickel was triggered on June 1, 2022.
+Added: We were obligated to make
+Added: the following payment pursuant to the Separation Agreement with Mr.
+Added: Nusbickel, dated May 10,2022:
Cash Severance
5 unchanged sentences
Number of Options
−Removed: (# that vested) and
+Added: (# that would vest) and
($ market value) (2)
−Removed: Khoso Baluch (3)
−Removed: Armstrong, Jr.
−Removed: Consists of COBRA payments.
−Removed: The market value equals the difference between the fair market value of the shares that could be acquired based on the closing sale price per share of our common stock on the Nasdaq Global Market on December 31, 2021, which was $4.55, and the exercise prices of the applicable stock options.
−Removed: We entered into a Separation Agreement with Mr.
−Removed: Baluch on October 4, 2021, and pursuant to that agreement, we paid Mr.
−Removed: Baluch an additional lump sum payment of $70,833 which represented base salary for 60 days as pay in lieu of notice.
−Removed: We entered into a Separation Agreement with Mr.
−Removed: Armstrong on October 4, 2021, and pursuant to that agreement, we paid Mr.
−Removed: Armstrong an additional lump sum payment of $54,167 which represented base salary for 60 days as pay in lieu of notice.
−Removed: Represents severance pay based on monthly base salary.
+Added: Thomas Nusbickel (3)
+Added: of COBRA payments.
+Added: market value equals the difference between the fair market value of the shares that could be acquired based on the closing sale price
+Added: per share of our common stock on the Nasdaq Global Market on December 31, 2022, which was $4.22, and the exercise prices of the applicable
+Added: stock options.
+Added: (3) Pursuant to Mr.
+Added: Nusbickel’s Separation Agreement, we paid Mr.
+Added: Nusbickel an additional lump sum payment of $39,423 which represented base salary for 44 days as pay in lieu of notice, and a prorated
+Added: bonus for the year of termination of $31,384.
+Added: (4) Represents
+Added: severance pay based on monthly base salary.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
−Removed: The following table shows
−Removed: the number of shares of our common stock beneficially owned as of March 25, 2022 by:
−Removed: each person known by us
−Removed: to own beneficially more than 5% of the outstanding shares of our common stock;
−Removed: each director;
−Removed: each of our Named Executive
−Removed: all of our current directors
−Removed: and executive officers as a group.
+Added: following table shows the number of shares of our common stock beneficially owned as of March 15, 2023 by:
+Added: person known by us to own beneficially more than 5% of the outstanding shares of our common stock;
+Added: of our Named Executive Officers;
+Added: of our current directors and executive officers as a group.
This table is based upon the information supplied
3 unchanged sentences
stock shown, and their address is c/o CorMedix Inc., 300 Connell Drive, Suite 4200, Berkeley Heights, New Jersey 07922.
−Removed: As March 25, 2022
+Added: At March 15, 2023
we had 44,499,788 shares of common stock outstanding.
−Removed: Beneficial ownership in each case also includes shares issuable upon exercise of
−Removed: outstanding options that can be exercised within 60 days after March 25, 2022 for purposes of computing the percentage of common stock
−Removed: owned by the person named.
−Removed: Options owned by a person are not included for purposes of computing the percentage owned by any other person.
+Added: Beneficial ownership in each case also includes shares issuable upon vesting of
+Added: restricted stock units within 60 days from March 15, 2023 and exercise of outstanding options that can be exercised within 60 days after
+Added: March 15, 2023 for purposes of computing the percentage of common stock owned by the person named.
+Added: Options owned by a person are not included
+Added: for purposes of computing the percentage owned by any other person.
Name and Address of Beneficial Owner
1 unchanged sentence
5% or Greater Stockholders
−Removed: Elliott Associates, L.P.
−Removed: BlackRock, Inc.
Nomura Global Financial Products, Inc.
3 unchanged sentences
Steven Lefkowitz (8)
−Removed: Joseph Todisco
Named Executive Officers:
+Added: Joseph Todisco (9)
Matthew David (10)
Phoebe Mounts (11)
−Removed: Elizabeth Masson-Hurlburt (13)
+Added: Elizabeth Hurlburt (12)
Thomas Nusbickel (13)
−Removed: Khoso Baluch (15)
−Removed: John Armstrong (16)
All executive officers and directors as a group (11 persons) (14)
* Less than 1%
−Removed: (1) Based upon 38,727,979 shares of our common stock outstanding on March
−Removed: 25, 2022 and, with respect to each individual holder, rights to acquire our common stock exercisable within 60 days of March 25, 2022.
−Removed: (2) Based solely on information contained in Amendment No.
−Removed: the Statement on Schedule 13D filed with the SEC on February 11, 2021 by Elliott Associates, L.P.
−Removed: (“Elliott Associates”),
−Removed: Elliott International, L.P.
−Removed: (“Elliott International”) and Elliott International Capital Advisors Inc.
−Removed: (“Elliott International
−Removed: Capital Advisors”, and together with Elliott Associates and Elliott International, the “Elliott Reporting Entities”),
−Removed: the investment manager of Elliott International, and other information known to us.
−Removed: The Elliott Reporting Entities may be deemed to collectively
−Removed: beneficially own 7,136,979 shares of our common stock, including (i) 1,184,889 shares of common stock outstanding, (ii) 391,953 shares
−Removed: of common stock issuable upon conversion of the Series E preferred stock, and (iii) 5,560,137 shares of common stock issuable upon conversion
−Removed: of the Series G preferred stock.
−Removed: The number of shares of our common stock into which the Series E and Series G preferred stock
−Removed: are convertible into, as applicable, are limited pursuant to the terms of the convertible securities to that number of shares of our
−Removed: common stock which would result in the Elliott Reporting Entities having aggregate beneficial ownership of not more than 4.99% (calculated
−Removed: in accordance with Rule 13d-4 under the Exchange Act) of the total issued and outstanding shares of our common stock (the “Ownership
−Removed: Limitation”).
−Removed: The Elliott Reporting Entities disclaim beneficial ownership of any and all shares of our common stock issuable upon
−Removed: any conversion of the convertible securities if such conversion would cause the Elliott Reporting Entities aggregate beneficial ownership
−Removed: of our common stock to exceed or remain above the Ownership Limitation.
−Removed: Therefore, the Elliott Reporting Entities disclaim beneficial
−Removed: ownership of any shares of our common stock, issuable upon any conversion of the Series E preferred stock and the Series G
−Removed: preferred stock, which conversion would be prohibited by the Ownership Limitation.
−Removed: The Ownership Limitation does not prevent the Elliott
−Removed: Reporting Entities or their affiliates from voting the shares of Series E and Series G preferred stock held by Elliott Associates
−Removed: and Elliott International.
−Removed: Accordingly, the shares of Series E preferred stock and Series G preferred stock, as of the record
−Removed: date, will be entitled to an aggregate of 2,682,477 votes.
−Removed: The business address of Elliott Investment Management L.P., the investment
−Removed: manager of the Elliott Reporting Entities, is 40 West 57 th Street, 30 th Floor, New York, New York 10019.
+Added: upon 44,499,788 shares of our common stock outstanding on March 15, 2023 and, with respect to each individual holder, rights to acquire
+Added: our common stock exercisable within 60 days of March 15, 2023.
Based solely on information contained in Amendment No.
−Removed: 1 to the Statement
−Removed: on Schedule 13G filed with the SEC on February 3, 2022 by BlackRock, Inc.
−Removed: (“BlackRock”).
−Removed: BlackRock has the sole voting
−Removed: power with respect to 2,450,933 shares of our common stock and the sole dispositive power with respect to 2,500,721 shares of our common
−Removed: The business address of BlackRock is 55 East 52 nd Street, New York, New York 10055.
−Removed: (4) Based solely on information contained on Schedule 13G filed
−Removed: with the SEC on February 14, 2022 by Nomura Global Financial Products, Inc.
−Removed: NGFP is a wholly owned subsidiary
−Removed: of Nomura Holdings, Inc., which accordingly may be deemed to beneficially own the shares beneficially owned by NGFP.
−Removed: shared voting power with respect to 2,003,612 shares of our common stock and the shared dispositive power with respect to 2,003,612 shares
−Removed: of our common stock.
+Added: 1 to the Statement on Schedule 13G filed with the SEC on February 14, 2023 by Nomura Global Financial Products, Inc.
+Added: NGFP is a wholly owned subsidiary of Nomura Holdings, Inc., which accordingly may be deemed to beneficially own the shares beneficially owned by NGFP.
+Added: NGFP has the shared voting power with respect to 2,952,334 shares of our common stock and the shared dispositive power with respect to 2,952,334 shares of our common stock.
The business address of NGFP is Worldwide Plaza, 309 West 49 th Street, New York, NY 10019.
−Removed: address of Nomura Holdings, Inc.
+Added: The business address of Nomura Holdings, Inc.
is 13-1, Nihonbashi 1-chome, Chuo-ku, Tokyo 103-8645, Japan.
−Removed: (5) Consists of 42,083 shares of our common stock issuable upon exercise
−Removed: of stock options.
+Added: Consists of 70,417 shares of our common stock issuable upon exercise of stock options.
Consists of (i) 53,473 shares of our common stock, and (ii) 131,667 shares of our common stock issuable upon exercise of stock options.
2 unchanged sentences
Consists of (i) 6,250 shares of our common stock, and (ii) 99,167 shares of our common stock issuable upon exercise of stock options.
−Removed: Consists of (i) 140,034 shares of our common stock held directly, (ii)
−Removed: 30,000 shares of our common stock held by Mr.
−Removed: Kaplan’s wife, 20,000 of which are held by her individually and 10,000 of which are
−Removed: held as a custodian for two of Mr.
−Removed: Kaplan’s grandchildren, and (iii) 91,000 shares of our common stock issuable upon exercise of
−Removed: stock options.
Consists of (i) 145,034 shares of our common stock held directly, (ii) 30,000 shares of our common stock held by Mr.
+Added: Kaplan’s wife, 20,000 of which are held by her individually and 10,000 of which are held as a custodian for two of Mr.
+Added: Kaplan’s grandchildren, and (iii) 112,667 shares of our common stock issuable upon exercise of stock options.
+Added: Consists of (i) 60,498 shares of our common stock held directly, (ii) 2,000 shares of our common stock held by Mr.
Lefkowitz’s wife, (iv) 30,152 shares of our common stock held by Wade Capital Corporation Money Purchase Plan, an entity for which Mr.
Lefkowitz has voting and investment control, and (v) 109,667 shares of our common stock issuable upon exercise of stock options.
−Removed: Consists of (i) 3,150 shares of our common stock, and (ii) 203,584 shares of our common stock issuable upon exercise of stock options.
+Added: Consists of (i) 34,700 shares of our common stock, (ii) 103,734 shares of our common stock issuable upon vesting of restricted stock units, and (iii) 225,000 shares of our common stock issuable upon exercise of stock options.
+Added: Consists of (i) 3,150 shares of our common stock, (ii) 342,584 shares of our common stock issuable upon exercise of stock options.
Consists of (i) 7,200 shares of our common stock, and (ii) 388,514 shares of our common stock issuable upon exercise of stock options.
1 unchanged sentence
Consists of 137,500 shares of our common stock issuable upon exercise of stock options.
−Removed: Consists of (i) 60,905 shares of our common stock, and (ii) 625,072 shares of our common stock issuable upon exercise of stock options.
−Removed: On October 1, 2021, we came to a mutual agreement with Mr.
−Removed: Baluch pursuant to which, Mr.
−Removed: Baluch retired from his position as our Chief Executive Officer, effective October 4, 2021.
−Removed: Baluch also resigned from our Board of Directors.
−Removed: Consists of (i) 96,878 shares of our common stock, and (ii) 169,253 shares of our common stock issuable upon exercise of stock options.
−Removed: On October 4, 2021, we came to a mutual agreement with Mr.
−Removed: Armstrong pursuant to which Mr.
−Removed: Armstrong retired from his position as our Executive Vice President, Technical Operations, effective October 4, 2021.
−Removed: Consists of the following held by our directors and executive officers
−Removed: (A) 302,757 shares of our common stock, and (B) 1,173,276 shares of our common stock issuable upon exercise of stock options.
−Removed: Stock Performance Graph
−Removed: The following performance graph shall not be deemed
−Removed: to be “soliciting material” or “filed” or incorporated by reference in future filings with the SEC, or subject
−Removed: to the liabilities of Section 18 of the Exchange Act except as shall be expressly set forth by specific reference in such filing.
−Removed: performance graph compares the performance of our common stock to the Russel 2000 Index and the NASDAQ Biotechnology Index.
−Removed: covers the most recent five-year period ended December 31, 2021.
−Removed: The graph assumes that the value of the investment in our common
−Removed: stock and each index was $100.00 at December 31, 2016, and that all dividends are reinvested.
+Added: On May 10, 2022, we came to a mutual agreement to part ways with Mr.
+Added: Nusbickel, our former Chief Commercial Officer, effective June 1, 2022.
+Added: Consists of the following held by our directors and executive officers (A) 376,357 shares of our common stock, (B) 103,734 shares of our common stock issuable upon vesting of restricted stock units, and (C) 1,986,910 shares of our common stock issuable upon exercise of stock options.
+Added: Compensation Plan Information
+Added: following table provides information as of December 31, 2022 about our common stock that may be issued upon the exercise of options,
+Added: warrants and rights under all of our existing equity compensation plans (including individual arrangements):
+Added: Plan Category
+Added: Number of securities
+Added: to be issued upon
+Added: exercise of outstanding
+Added: options, warrants and
+Added: Weighted-average
+Added: exercise price of
+Added: outstanding options,
+Added: warrants and rights
+Added: securities remaining
+Added: available for future
+Added: issuance under equity
+Added: compensation plans
+Added: (excluding securities
+Added: reflected in column
+Added: Equity compensation plans approved by security holders (1)
+Added: 4,661,838 (2)
+Added: 2013 Stock Incentive Plan was approved by our stockholders on July 30, 2013.
+Added: Our 2019 Omnibus Stock Incentive Plan was approved by our
+Added: stockholders on November 26, 2019.
+Added: Our Amended and Restated 2019 Omnibus Stock Incentive Plan was approved by our stockholders on October
+Added: of 4,454,369 underlying stock options and 207,469 underlying restricted stock units.
+Added: (3) Applicable
+Added: to shares underlying outstanding stock options only.
+Added: Performance Graph
+Added: following performance graph shall not be deemed to be “soliciting material” or “filed” or incorporated by reference
+Added: in future filings with the SEC, or subject to the liabilities of Section 18 of the Exchange Act except as shall be expressly set forth
+Added: by specific reference in such filing.
+Added: The performance graph compares the performance of our common stock to the NASDAQ Composite and
+Added: the NASDAQ Biotechnology Index.
+Added: The graph covers the most recent five-year period ended December 31, 2022.
+Added: The graph assumes that
+Added: the value of the investment in our common stock and each index was $100.00 at December 31, 2017, and that all dividends are reinvested.
Cumulative Total Return
CorMedix Inc.
+Added: NASDAQ Composite
NASDAQ Biotechnology
Certain Relationships and Related Transactions and Director Independence
−Removed: Related Party Transactions
−Removed: February 2021, Manchester Securities Corp., Elliott Associates LP and Elliott International LP (collectively, “Elliott”),
−Removed: an existing institutional investor who collectively beneficially own the largest portion of the Company’s common stock,
−Removed: converted an aggregate of 10,001 Series G preferred shares into an aggregate of 556,069 shares of our common stock.
−Removed: Procedures for Review and Approval
−Removed: of Transactions with Related Persons
−Removed: Pursuant to the Audit Committee Charter, the Audit
−Removed: Committee is responsible for reviewing and approving all related party transactions as defined under Item 404 of Regulation S-K, after
−Removed: reviewing each such transaction for potential conflicts of interests and other improprieties.
−Removed: Our policies and procedures for review
−Removed: and approval of transactions with related persons are in writing in our Code of Conduct and Ethics available on our website at www.cormedix.com
−Removed: under the “Investor Relations—Corporate Governance” tab.
+Added: Party Transactions
+Added: related party transactions occurred during the Fiscal year ended December 31, 2022.
+Added: In February 2021, Manchester Securities Corp., Elliott
+Added: Associates LP and Elliott International LP (collectively, “Elliott”), an existing institutional investor who collectively
+Added: beneficially own the largest portion of the Company’s common stock, converted an aggregate of 10,001 Series G preferred shares
+Added: into an aggregate of 556,069 shares of our common stock.
+Added: for Review and Approval of Transactions with Related Persons
+Added: to the Audit Committee Charter, the Audit Committee is responsible for reviewing and approving all related party transactions as defined
+Added: under Item 404 of Regulation S-K, after reviewing each such transaction for potential conflicts of interests and other improprieties.
+Added: Our policies and procedures for review and approval of transactions with related persons are in writing in our Code of Conduct and Ethics
+Added: available on our website at www.cormedix.com under the “Investor Relations—Corporate Governance” tab.
The information on Board independence is found
−Removed: in Item 10 of this Report under the heading “Board Independence.”
+Added: in Item 10 of this Annual Report on Form 10-K under the heading “Board Independence.”
Principal Accounting Fees and Services
−Removed: Fees Paid to the Independent Registered Public Accounting Firm
−Removed: The following table sets forth fees billed to
−Removed: us by Friedman LLP, our independent registered public accounting firm for the years ended December 31, 2021 and 2020, for services relating
+Added: Paid to the Independent Registered Public Accounting Firm
+Added: following table sets forth fees billed to us by Friedman LLP and Marcum LLP, our independent registered public accounting firms for the
+Added: years ended December 31, 2022 and 2021, for services relating to:
auditing our annual financial statements;
−Removed: reviewing our financial statements included in our quarterly reports on Form 10-Q;
−Removed: registration statements during 2021 and 2020;
−Removed: financing activities in 2021 and 2020;
−Removed: and services rendered in connection with tax compliance,
−Removed: tax advice and tax planning, and all other fees for services rendered.
−Removed: Audit Related Fees
+Added: reviewing our financial statements
+Added: included in our quarterly reports on Form 10-Q;
+Added: reviewing registration statements during 2022 and 2021;
+Added: financing activities in 2022
+Added: and services rendered in connection with tax compliance, tax advice and tax planning, and all other fees for services rendered.
+Added: Audit Fees (Friedman LLP)
+Added: Audit Fees (Marcum LLP)
+Added: Audit Related Fees (Friedman LLP)
All Other Fees
−Removed: Audit Committee Pre-Approval Policies and Procedures
−Removed: Pursuant to its charter, the Audit Committee is responsible for reviewing
−Removed: and approving in advance any audit and any permissible non-audit engagement or relationship between us and our independent registered
−Removed: public accounting firm.
−Removed: The Audit Committee may delegate to one or more designated members of the Audit Committee the authority to grant
−Removed: pre-approvals, provided such approvals are presented to the Audit Committee at a subsequent meeting.
−Removed: If the Audit Committee elects to
−Removed: establish pre-approval policies and procedures regarding non-audit services, the Audit Committee must be informed of each non-audit service
−Removed: provided by our independent registered public accounting firm.
−Removed: Audit Committee pre-approval of audit and non-audit services will not be
−Removed: required if the engagement for the services is entered into pursuant to pre-approval policies and procedures, provided the policies and
−Removed: procedures are detailed as to the particular service, the Audit Committee is informed of each service provided and such policies and procedures
−Removed: do not include delegation of the Audit Committee’s responsibilities under the Exchange Act to our management.
−Removed: Audit Committee pre-approval
−Removed: of non-audit services (other than review and attestation services) also will not be required if such services fall within available exceptions
−Removed: established by the SEC.
−Removed: All services performed by our independent registered public accounting firm during 2021 were pre-approved by the
−Removed: Audit Committee.
+Added: Committee Pre-Approval Policies and Procedures
+Added: Pursuant to its charter, the Audit Committee is
+Added: responsible for reviewing and approving in advance any audit and any permissible non-audit engagement or relationship between us and our
+Added: independent registered public accounting firm.
+Added: The Audit Committee may delegate to one or more designated members of the Audit Committee
+Added: the authority to grant pre-approvals, provided such approvals are presented to the Audit Committee at a subsequent meeting.
+Added: Committee elects to establish pre-approval policies and procedures regarding non-audit services, the Audit Committee must be informed
+Added: of each non-audit service provided by our independent registered public accounting firm.
+Added: Audit Committee pre-approval of audit and non-audit
+Added: services will not be required if the engagement for the services is entered into pursuant to pre-approval policies and procedures, provided
+Added: the policies and procedures are detailed as to the particular service, the Audit Committee is informed of each service provided and such
+Added: policies and procedures do not include delegation of the Audit Committee’s responsibilities under the Exchange Act to our management.
+Added: Audit Committee pre-approval of non-audit services (other than review and attestation services) also will not be required if such services
+Added: fall within available exceptions established by the SEC.
+Added: All services performed by our independent registered public accounting firm during
+Added: 2022 were pre-approved by the Audit Committee.
Exhibits, Financial Statement Schedules
−Removed: (a) List of documents filed as part of this report:
−Removed: Financial Statements:
−Removed: The financial statements of
−Removed: the Company and the related reports of the Company’s independent registered public accounting firms thereon have been filed under
−Removed: Item 8 hereof.
−Removed: Financial Statement Schedules:
+Added: List of documents filed as part of this report:
+Added: financial statements of the Company and the related reports of the Company’s independent registered public accounting firms thereon
+Added: have been filed under Item 8 hereof.
+Added: Statement Schedules:
Exhibit Index
−Removed: The following is a list of
−Removed: exhibits filed as part of this Form 10-K:
+Added: following is a list of exhibits filed as part of this Annual Report on Form 10-K:
Description of Document
−Removed: At Market Issuance Sales Agreement, dated March 9, 2018, between CorMedix Inc.
+Added: Exhibit Number
+Added: Filed Herewith
+Added: At-the-Market Issuance Sales Agreement, dated March 9, 2018, between CorMedix Inc.
Riley FBR, Inc.
−Removed: Amended and Restated At Market Issuance Sales Agreement, dated November 27, 2020, by and among CorMedix Inc., B.
+Added: Amended and Restated At-the-Market Issuance Sales Agreement, dated November 27, 2020, by and among CorMedix Inc., B.
Riley Securities, Inc.
and Needham & Company LLC
−Removed: At Market Issuance Sales Agreement, dated August 12, 2021, by and among CorMedix Inc., Truist Securities, Inc.
+Added: At-the-Market Issuance Sales Agreement, dated August 12, 2021, by and among CorMedix Inc., Truist Securities, Inc.
and JMP Securities LLC
1 unchanged sentence
Certificate of Amendment to Amended and Restated Certificate of Incorporation, dated February 24, 2010
−Removed: Description of Document
Second Amended and Restated Bylaws as amended October 8, 2020
12 unchanged sentences
License and Assignment Agreement, dated as of January 30, 2008, between the Company and ND Partners LLC
+Added: Description of Document
+Added: Exhibit Number
+Added: Filed Herewith
Escrow Agreement, dated as of January 30, 2008, among the Company, ND Partners LLC and the Secretary of the Company, as Escrow Agent
1 unchanged sentence
2013 Stock Incentive Plan
−Removed: Executive Employment Agreement, dated as of September 26, 2019, between CorMedix Inc.
−Removed: and Khoso Baluch
−Removed: Separation Agreement and Release, dated October 4, 2021, between CorMedix Inc.
−Removed: and Khoso Baluch.
Executive Employment Agreement, dated and effective May 11, 2020, between CorMedix Inc.
2 unchanged sentences
and Matthew David, M.D.
−Removed: Description of Document
−Removed: Executive Employment Agreement, dated and effective April 17, 2020, between CorMedix Inc.
−Removed: and John Armstrong.
−Removed: Separation Agreement, dated October 4, 2021, between CorMedix Inc.
−Removed: Armstrong, Jr.
Form of Securities Purchase Agreement, dated November 17, 2017, between CorMedix Inc.
8 unchanged sentences
Executive Employment Agreement, dated and effective March 10, 2021, between CorMedix Inc.
−Removed: and Elizabeth Masson-Hurlburt
+Added: and Elizabeth Hurlburt
Securities Purchase Agreement, dated December 31, 2018, between CorMedix Inc.
8 unchanged sentences
2019 Omnibus Stock Incentive Plan
+Added: Amended and Restated 2019 Omnibus Stock Incentive Plan
Executive Employment Agreement, dated April 29, 2021, between CorMedix Inc.
5 unchanged sentences
Consent of Independent Registered Public Accounting Firm
+Added: Consent of Independent Registered Public Accounting Firm
+Added: Description of Document
+Added: Exhibit Number
+Added: Filed Herewith
Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
−Removed: Certification of Principal Executive Officer and Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
+Added: Certification of Principal Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
+Added: Certification of Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
The following materials from CorMedix Inc.
−Removed: Form 10-K for the year ended
−Removed: December 31, 2021, formatted in Extensible Business Reporting Language (XBRL):
−Removed: (i) Balance Sheets at December 31, 2021 and 2020, (ii)
−Removed: Statements of Operations for the years ended December 31, 2021 and 2020, (iii) Statements of Changes in Stockholders’ Equity for
−Removed: the years ended December 31, 2021 and 2020, (iv) Statements of Cash Flows for the years ended December 31, 2021 and 2020 and (v) Notes
−Removed: to the Financial Statements.**
+Added: Form 10-K for the year ended December 31, 2022, formatted in Extensible Business Reporting Language (XBRL):
+Added: (i) Balance Sheets at December 31, 2022 and 2021, (ii) Statements of Operations for the years ended December 31, 2022 and 2021, (iii) Statements of Changes in Stockholders’ Equity for the years ended December 31, 2022 and 2021, (iv) Statements of Cash Flows for the years ended December 31, 2022 and 2021 and (v) Notes to the Financial Statements.**
Inline XBRL Instance Document.
5 unchanged sentences
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
−Removed: Confidential treatment has been granted for portions of this document.
−Removed: The omitted portions of this
−Removed: document have been filed separately with the SEC.
−Removed: Portions of the exhibit have been omitted in reliance on Item 601(b)(10)(iv) of Regulation S-K.
−Removed: Indicates management contract or compensation plan.
+Added: of the exhibit have been omitted in reliance on Item 601(b)(10)(iv) of Regulation S-K.
+Added: management contract or compensation plan.
Form 10-K Summary
−Removed: Not applicable.
−Removed: Pursuant to the requirements
−Removed: of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto
+Added: Pursuant to the requirements of the Securities
+Added: Exchange Act of 1934, the Registrant has duly caused this Annual Report on Form 10-K to be signed on its behalf by the undersigned thereunto
duly authorized.
−Removed: CORMEDIX INC.
−Removed: March 29, 2022
−Removed: /s/ Matthew David
−Removed: Matthew David
−Removed: Interim Chief Executive Officer and Chief Financial Officer
−Removed: (Principal Executive Officer)
−Removed: March 29, 2022
+Added: /s/ Joseph Todisco
+Added: Executive Officer
+Added: Executive Officer)
/s/ Matthew David
−Removed: Matthew David
−Removed: Interim Chief Executive Officer and Chief Financial Officer
−Removed: (Principal Financial and Accounting Officer)
−Removed: Pursuant to the requirements
−Removed: of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in
+Added: Financial Officer
+Added: Financial and Accounting Officer)
+Added: Pursuant to the requirements of the Securities
+Added: Exchange Act of 1934, this Annual Report on Form 10-K has been signed below by the following persons on behalf of the Registrant and in
the capacities and on the dates indicated:
−Removed: /s/ Matthew David
−Removed: Interim Chief Executive Officer and Chief Financial Officer
−Removed: March 29, 2022
−Removed: Matthew David
−Removed: (Principal Executive Officer)
−Removed: /s/ Matthew David
−Removed: Interim Chief Executive Officer and Chief Financial Officer
−Removed: March 29, 2022
+Added: Joseph Todisco
+Added: Executive Officer and Director
+Added: Executive Officer)
Matthew David
−Removed: (Principal Financial and Accounting Officer)
−Removed: /s/ Myron Kaplan
−Removed: Director and Chairman of the Board
−Removed: March 29, 2022
−Removed: /s/ Paulo Costa
−Removed: March 29, 2022
−Removed: /s/ Janet Dillione
−Removed: March 29, 2022
+Added: Financial Officer
+Added: Financial and Accounting Officer)
+Added: and Chairman of the Board
Janet Dillione
−Removed: /s/ Gregory Duncan
−Removed: March 29, 2022
Gregory Duncan
−Removed: /s/ Alan Dunton
−Removed: March 29, 2022
−Removed: /s/ Steven Lefkowitz
−Removed: March 29, 2022
Steven Lefkowitz
−Removed: /s/ Joseph Todisco
−Removed: March 29, 2022
−Removed: Joseph Todisco
CORMEDIX INC.
1 unchanged sentence
FINANCIAL STATEMENTS
−Removed: Financial Statements Index
−Removed: Report of Independent Registered Public Accounting Firm (PCAOB ID # 711 ) F-2
+Added: Financial Statements
+Added: Reports of Independent Registered Public Accounting Firms Marcum LLP , (PCAOB ID 688), Friedman LLP, (PCAOB ID 711 ) F-2
Consolidated Balance Sheets as of December 31, 2022 and 2021 F-4
−Removed: Consolidated Statements of Operations and Comprehensive Income (Loss) Years Ended December 31, 2021 and 2020 F-5
−Removed: Consolidated Statements of Changes in Stockholders’ Equity Years Ended December 31, 2021 and 2020 F-6
−Removed: Consolidated Statements of Cash Flows Years Ended December 31, 2021 and 2020 F-7
+Added: Consolidated Statements of Operations and Comprehensive Income (Loss) Years Ended December 31, 2022 and 2021
+Added: Consolidated Statements of Changes in Stockholders’ Equity Years Ended December 31, 2022 and 2021
+Added: Consolidated Statements of Cash Flows Years Ended December 31, 2022 and 2021
Notes to Consolidated Financial Statements F-8
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
−Removed: To the Board of Directors and
−Removed: Stockholders of CorMedix Inc.
−Removed: Opinion on the Consolidated Financial Statements
−Removed: We have audited the accompanying consolidated
−Removed: balance sheets of CorMedix, Inc.
−Removed: and Subsidiaries (the “Company”) as of December 31, 2021 and 2020, and the related consolidated
−Removed: statements of operations and comprehensive income (loss), changes in stockholders’ equity, and cash flows for each of the years
−Removed: in the two-year period ended December 31, 2021, and the related notes (collectively referred to as the “consolidated financial statements”).
−Removed: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company
−Removed: as of December 31, 2021 and 2020, and the results of its operations and its cash flows for each of the years in the two-year period ended
+Added: To the Stockholders and
+Added: Board of Directors of CorMedix Inc.
+Added: Opinion on the Financial Statements
+Added: We have audited the accompanying consolidated balance sheet of CorMedix
+Added: and Subsidiaries (the “Company”) as of December 31, 2022, the related consolidated statements of operations and comprehensive
+Added: income (loss), changes in stockholders’ equity and cash flows for the year ended December 31, 2022, and the related notes (collectively
+Added: referred to as the “financial statements”).
+Added: In our opinion, the financial statements present fairly, in all material respects,
+Added: the financial position of the Company as of December 31, 2022, and the results of its operations and its cash flows for the year ended
December 31, 2022, in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
+Added: These financial statements are the responsibility
+Added: of the Company’s management.
+Added: Our responsibility is to express an opinion on the Company’s financial statements based on our audit.
+Added: are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are
+Added: required to be independent with respect to the Company in accordance with the U.S.
+Added: federal securities laws and the applicable rules and
+Added: regulations of the Securities and Exchange Commission and the PCAOB.
+Added: We conducted our audit in accordance with the
+Added: standards of the PCAOB.
+Added: Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial
+Added: statements are free of material misstatement, whether due to error or fraud.
+Added: The Company is not required to have, nor were we engaged
+Added: to perform, an audit of its internal control over financial reporting.
+Added: As part of our audit we are required to obtain an understanding
+Added: of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal
+Added: control over financial reporting.
+Added: Accordingly, we express no such opinion.
+Added: Our audit included performing procedures to assess the risks of material
+Added: misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks.
+Added: Such procedures
+Added: included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
+Added: Our audit also included
+Added: evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation
+Added: of the financial statements.
+Added: We believe that our audit provides a reasonable basis for our opinion.
+Added: Critical Audit Matters
+Added: Critical audit matters are matters arising from
+Added: the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and
+Added: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging,
+Added: subjective, or complex judgments.
+Added: We determined that there are no critical audit matters.
+Added: /s/ Marcum LLP
+Added: We have served as the Company’s auditor since
+Added: 2014 (such date takes into account the acquisition of certain assets of Friedman LLP by Marcum LLP effective September 1, 2022).
+Added: Marlton, New Jersey
+Added: March 30, 2023
+Added: REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
+Added: To the Stockholders and
+Added: Board of Directors of CorMedix Inc.
+Added: Opinion on the Consolidated Financial Statements
+Added: We have audited the accompanying consolidated balance sheet of CorMedix
+Added: and Subsidiaries (the “Company”) as of December 31, 2021, and the related consolidated statements of operations, stockholders’
+Added: deficit, and cash flows for the year ended December 31, 2021, and the related notes (collectively referred to as the “consolidated
+Added: financial statements”).
+Added: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial
+Added: position of the Company as of December 31, 2021, and the results of its operations and its cash flows for the year ended December 31,
+Added: 2021, in conformity with accounting principles generally accepted in the United States of America.
+Added: Basis for Opinion
These consolidated financial statements are the responsibility of the
Company’s management.
−Removed: Our responsibility is to express an opinion on the Company’s consolidated financial statements based
−Removed: on our audits.
+Added: Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audit.
We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and
2 unchanged sentences
and regulations of the Securities and Exchange Commission and the PCAOB.
−Removed: We conducted our audits in accordance with the standards of the PCAOB.
+Added: We conducted our audit in accordance with the standards of the PCAOB.
Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements
2 unchanged sentences
an audit of its internal control over financial reporting.
−Removed: As part of our audits, we are required to obtain an understanding of internal
−Removed: control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal
−Removed: control over financial reporting.
+Added: As part of our audit we are required to obtain an understanding of internal
+Added: control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control
+Added: over financial reporting.
Accordingly, we express no such opinion.
−Removed: Our audits included performing procedures to assess the risks of material
+Added: Our audit included performing procedures to assess the risks of material
misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those
Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial
−Removed: Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as
+Added: Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as
evaluating the overall presentation of the consolidated financial statements.
−Removed: We believe that our audits provide a reasonable basis for
−Removed: Critical Audit Matter
−Removed: The critical audit matters communicated below are matters arising from
−Removed: the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee
−Removed: (1) relate to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially
−Removed: challenging, subjective, or complex judgments.
−Removed: The communication of critical audit matters does not alter in any way our opinion on the
−Removed: consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate
−Removed: opinions on the critical audit matters or on the accounts or disclosures to which they relate.
−Removed: Critical Audit Matter Description
−Removed: Stock Based Compensation
−Removed: During the year ended December 31, 2021, the Company recorded stock-based
−Removed: compensation expense of approximately $5.0 million.
−Removed: As discussed in Note 7 to the consolidated financial statements, the Company issues
−Removed: various types of equity awards, including stock options and restricted stock units.
−Removed: Auditing the Company’s accounting for stock-based compensation
−Removed: required complex auditor judgment due to the number and variety of equity awards outstanding, the inclusion of market and performance
−Removed: vesting criteria in certain awards, and the subjectivity of assumptions used to value stock-based awards.
−Removed: In particular, judgment was
−Removed: required to evaluate the nature of the performance conditions, as well as to assess the satisfaction of the performance targets.
−Removed: How We Addressed the Matter in Our Audit
−Removed: To test stock based-compensation expense, we performed audit procedures
−Removed: that included, among others, obtaining an understanding of the Company’s controls over stock-based compensation, assessing the completeness
−Removed: of the awards granted and evaluating the methodologies used to estimate the fair value of these awards.
−Removed: We also tested the accuracy of
−Removed: the data used in measuring the awards by agreeing the underlying inputs, such as grant date, grant price, performance targets and vesting
−Removed: terms, among others, back to source documents, such as compensation meeting minutes or award letters and testing the clerical accuracy
−Removed: of the calculation of the expense recorded.
−Removed: We determined whether milestone targets were satisfied in accordance with the contractual
−Removed: conditions and recalculated grant date fair value.
−Removed: We also evaluated the adequacy of the Company’s stock-based compensation disclosures
−Removed: included in Note 7 in relation to these matters.
+Added: We believe that our audit provides a reasonable basis for
/s/ Friedman LLP
−Removed: We have served as the Company’s auditor since 2014.
+Added: We served as the Company’s auditor from 2014 through 2022.
March 29, 2022
8 unchanged sentences
Prepaid research and development expenses
−Removed: Security deposit
Other prepaid expenses and current assets
15 unchanged sentences
2,000,000 shares authorized;
−Removed: 181,622 and 241,623 shares issued and outstanding at December 31, 2021 and 2020, respectively
+Added: 181,622 shares issued and outstanding at December 31, 2022 and 2021
Common stock - $ 0.001 par value:
14 unchanged sentences
Years Ended December 31, 2022
−Removed: 2021 and 2020
Cost of sales
14 unchanged sentences
Interest income
−Removed: Foreign exchange transaction loss
+Added: Foreign exchange transaction income (loss)
Interest expense
6 unchanged sentences
Other Comprehensive Income (Loss):
−Removed: Unrealized loss from investments
−Removed: Foreign currency translation (loss) gain
−Removed: Total other comprehensive (loss) income
+Added: Unrealized gain (loss) from investments
+Added: Foreign currency translation loss
+Added: Total other comprehensive loss
Comprehensive Loss
6 unchanged sentences
CORMEDIX INC.
−Removed: AND SUBSIDIARY
−Removed: CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIENCY)
+Added: AND SUBSIDIARIES
+Added: CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
Years Ended December 31, 2022 and 2021
4 unchanged sentences
Comprehensive
+Added: Stockholders’
Balance at December 31, 2020
1 unchanged sentence
$ ( 217,448,855 )
−Removed: Stock issued in connection with public offering, net
Stock issued in connection with ATM sale of common stock, net
−Removed: Stock issue in connection with warrants exercised
−Removed: Issuance of vested restricted stock
+Added: Stock issued in connection with warrants exercised, cash
+Added: Stock issued in connection with warrants exercised, cashless
+Added: Stock issued in connection with options exercised
+Added: Conversion of Series G preferred shares to common stock
+Added: Conversion of Series C-3 preferred shares to common stock
Stock-based compensation
−Removed: Other comprehensive income
+Added: Other comprehensive loss
( 28,210,226 )
5 unchanged sentences
Stock issued in connection with warrants exercised, cash
−Removed: Stock issued in connection with warrants exercised, cashless
−Removed: Stock issued in connection with options exercised
−Removed: Conversion of Series G preferred shares to common stock
−Removed: Conversion of Series C-3 preferred shares to common stock
Stock-based compensation
17 unchanged sentences
Change in right-of-use assets
−Removed: Inventory reserve
Changes in operating assets and liabilities:
−Removed: Change in operating lease liabilities
−Removed: Increase in trade receivables
+Added: Decrease (Increase) in trade receivables
Decrease in inventory
−Removed: Decrease (Increase) in prepaid expenses and other current assets
−Removed: Increase in accounts payable
−Removed: Decrease in accrued expenses
−Removed: ( 1,883,149 )
−Removed: Decrease in deferred revenue
+Added: Decrease in prepaid expenses and other current assets
+Added: (Decrease) Increase in accounts payable
+Added: Increase in accrued expenses
+Added: Decrease in operating lease liabilities
Net cash used in operating activities
8 unchanged sentences
( 1,425,329 )
−Removed: Net cash (used in) provided by investing activities
+Added: Net cash used in investing activities
( 3,709,364 )
+Added: ( 9,134,915 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from sale of common stock from at-the-market program, net
−Removed: Proceeds from the public offering, net
Proceeds from exercise of warrants
2 unchanged sentences
Foreign exchange effects on cash
−Removed: NET INCREASE IN CASH AND CASH EQUIVALENTS
+Added: NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS
+Added: ( 10,176,532 )
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH – BEGINNING OF YEAR
4 unchanged sentences
Conversion of Series C-3 preferred stock to common stock
−Removed: Unrealized loss from investments
+Added: Unrealized gain (loss) from investments
Deposit on equipment reclassified from prepaid expenses and current assets to property and equipment, net
−Removed: Right-of-use assets obtained in exchange for lease liability
−Removed: Issuance of common stock for vested restricted stock units
The accompanying notes are integral part of these
3 unchanged sentences
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Note 1 — Organization, Business and Basis of
−Removed: Presentation:
+Added: Note 1 — Organization, Business and Basis of Presentation:
Organization and Business:
CorMedix Inc.
−Removed: (“CorMedix” or the “Company”)
−Removed: was incorporated in the State of Delaware on July 28, 2006.
−Removed: The Company is a biopharmaceutical company focused on developing and commercializing
−Removed: therapeutic products for the prevention and treatment of infectious and inflammatory diseases.
−Removed: In 2013, the Company formed a wholly-owned
−Removed: subsidiary, CorMedix Europe GmbH and in May 2020, the Company formed a wholly-owned Spanish subsidiary, CorMedix Spain, S.L.U.
+Added: (“CorMedix” or the
+Added: “Company”) was incorporated in the State of Delaware on July 28, 2006.
+Added: The Company is a biopharmaceutical company
+Added: focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory
+Added: In 2013, the Company formed a wholly-owned subsidiary, CorMedix Europe GmbH and in May 2020, the Company formed a
+Added: wholly-owned Spanish subsidiary, CorMedix Spain, S.L.U.
+Added: As announced in May 2022, the Company began the process of winding down its
+Added: operations in the EU and expects to discontinue Neutrolin sales in both the EU and the Middle East by the end of 2022.
The Company’s primary focus is to develop
its lead product candidate, DefenCath™, for potential commercialization in the United States (“U.S.”) and other key
−Removed: The Company has in-licensed the worldwide rights to develop and commercialize DefenCath/Neutrolin®, which is a novel anti-infective
−Removed: solution (a formulation of taurolidine 13.5 mg/mL, and heparin 1000 USP Units/mL) intended for the reduction and prevention of catheter-related
−Removed: infections and thrombosis in patients requiring central venous catheters in clinical settings such as hemodialysis, total parenteral nutrition,
−Removed: and oncology.
+Added: The Company has in-licensed the worldwide rights to develop and commercialize DefenCath and Neutrolin ® , which
+Added: is a novel anti-infective solution (a formulation of taurolidine 13.5 mg/mL, and heparin 1000 USP Units/mL) intended for the reduction
+Added: and prevention of catheter-related infections and thrombosis in patients requiring central venous catheters in clinical settings such
+Added: as hemodialysis, total parenteral nutrition, and oncology.
The name DefenCath is the U.S.
−Removed: proprietary name conditionally approved by the U.S.
−Removed: Food and Drug Administration (“FDA”),
−Removed: while the name Neutrolin is currently used in the European Union (“EU”) and other territories where the Company has received
−Removed: CE-Mark approval for the commercial distribution of Neutrolin as a catheter lock solution (“CLS”) regulated as a medical device.
−Removed: In January 2015, the FDA designated DefenCath
−Removed: as a Qualified Infectious Disease Product (“QIDP”) for prevention of catheter-related blood stream infections in patients
−Removed: with end stage renal disease receiving hemodialysis through a central venous catheter.
−Removed: Catheter-related blood stream infections and clotting
−Removed: can be life-threatening.
−Removed: The QIDP designation provides five years of market exclusivity in addition to the five years granted for a New
−Removed: Chemical Entity upon approval of a New Drug Application (“NDA”).
−Removed: In addition, in January 2015, the FDA granted Fast Track
−Removed: designation to DefenCath Catheter Lock Solution, a designation intended to facilitate development and expedite review of drugs that treat
−Removed: serious and life-threatening conditions so that the approved drug can reach the market expeditiously.
−Removed: The Fast Track designation of DefenCath
−Removed: provides us with the opportunity to meet with the FDA on a more frequent basis during the development process, and also ensures eligibility
−Removed: to request priority review of the marketing application.
−Removed: In December 2015, the Company launched its Phase
−Removed: 3 Prospective, Multicenter, Double-blind, Randomized, Active Control Study to Demonstrate Safety & Effectiveness of DefenCath/Neutrolin
−Removed: in Preventing Catheter-related Bloodstream Infection in Subjects on Hemodialysis for End Stage Renal Disease (“LOCK-IT-100”),
−Removed: in patients with hemodialysis catheters in the U.S.
−Removed: The clinical trial was designed to demonstrate the safety and effectiveness of DefenCath
−Removed: compared to the standard of care CLS, Heparin, in preventing CRBSIs.
−Removed: The primary endpoint for the trial assessed the incidence of CRBSI
−Removed: and time to CRBSI for each study subject.
−Removed: Secondary endpoints were catheter patency, which was defined as required use of tissue plasminogen
−Removed: activating factor, or tPA, or removal of catheter due to dysfunction, and removal of catheter for any reason.
−Removed: As previously agreed with the FDA, an interim
−Removed: efficacy analysis was performed when the first 28 potential CRBSI cases were identified in our LOCK-IT-100 study that occurred through
−Removed: early December 2017.
−Removed: Based on these first 28 cases, there was a highly statistically significant 72% reduction in CRBSI by DefenCath
−Removed: relative to the active control of heparin (p=0.0034).
−Removed: Because the pre-specified level of statistical significance was reached for the
−Removed: primary endpoint and efficacy had been demonstrated with no safety concerns, the LOCK-IT-100 study was terminated early.
−Removed: The study continued
−Removed: enrolling and treating subjects until study termination, and the final analysis was based on a total of 795 subjects.
−Removed: In a total of 41
−Removed: cases, there was a 71% reduction in CRBSI by DefenCath relative to heparin, which was highly statistically significant (p=0.0006), with
−Removed: a good safety profile.
−Removed: The FDA granted the Company’s request for
−Removed: a rolling submission and review of the NDA which is designed to expedite the approval process for products being developed to address
−Removed: an unmet medical need.
−Removed: Although the FDA usually requires two pivotal clinical trials to provide substantial evidence of safety and effectiveness
−Removed: for approval of an NDA, the FDA will in some cases accept one adequate and well-controlled trial, where it is a large multicenter trial
−Removed: with a broad range of subjects and investigation sites with procedures to include trial quality that has demonstrated a clinically meaningful
−Removed: and statistically very persuasive effect on prevention of a disease with potentially serious outcome.
−Removed: CORMEDIX INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
−Removed: In March 2020, the Company began the modular submission
−Removed: process for the NDA for DefenCath for the prevention of CRBSI in hemodialysis patients, and in August 2020, the FDA accepted for filing
−Removed: the DefenCath NDA.
−Removed: The FDA also granted the Company’s request for priority review, which provides for a six-month review period
−Removed: instead of the standard ten-month review period.
−Removed: As announced in March 2021, the FDA informed in its Complete Response Letter (“CRL”),
−Removed: to the Company that it cannot approve the NDA for DefenCath in its present form.
−Removed: The FDA noted concerns at the third-party manufacturing
−Removed: facility after a review of records requested by the FDA and provided by the contract manufacturing organization (“CMO”).
−Removed: Additionally,
−Removed: the FDA is requiring a manual extraction study to demonstrate that the labeled volume can be consistently withdrawn from the vials despite
−Removed: an existing in-process control to demonstrate fill volume within specifications.
−Removed: In April 2021, the Company and the CMO met with
−Removed: the FDA to discuss proposed resolutions for the deficiencies identified in the CRL to the Company and the Post-Application Action Letter
−Removed: (“PAAL”), received by the CMO from the FDA for the NDA for DefenCath.
−Removed: There was an agreed upon protocol for the manual extraction
−Removed: study identified in the CRL, which now has been successfully completed.
−Removed: Addressing the FDA’s concerns regarding the qualification
−Removed: of the filling operation necessitated adjustments in the process and generation of additional data on operating parameters for manufacture
−Removed: of DefenCath.
−Removed: The Company and the CMO determined that additional process qualification is needed with subsequent validation to address
−Removed: these issues.
−Removed: The FDA did not request additional clinical data and did not identify any deficiencies related to the data submitted on
−Removed: the efficacy or safety of DefenCath from LOCK-IT-100.
−Removed: In draft labeling discussed with the FDA, the FDA added that the initial approval
−Removed: will be for the limited population of patients with kidney failure receiving chronic hemodialysis through a central venous catheter.
−Removed: This is consistent with the Company’s request for approval pursuant to the Limited Population Pathway for Antibacterial and Antifungal
−Removed: Drugs (“LPAD”).
−Removed: LPAD, passed as part of the 21st Century Cures Act, is a new program intended to expedite the development
−Removed: and approval of certain antibacterial and antifungal drugs to treat serious or life-threatening infections in limited populations of
−Removed: patients with unmet needs.
−Removed: LPAD provides for a streamlined clinical development program involving smaller, shorter, or fewer clinical
−Removed: trials and is intended to encourage the development of safe and effective products that address unmet medical needs of patients with
−Removed: serious bacterial and fungal infections.
−Removed: The Company believes that LPAD will provide additional flexibility for the FDA to approve DefenCath
−Removed: to prevent CRBSIs in the limited population of patients with kidney failure receiving hemodialysis through a central venous catheter.
−Removed: On February 28, 2022, the Company announced that
−Removed: it resubmitted the NDA for DefenCath to address the CRL issued by the FDA.
−Removed: In parallel, the Company’s third-party manufacturer
−Removed: submitted responses to the deficiencies identified at the manufacturing facility in the PAAL issued by the FDA concurrently with the
−Removed: The FDA will evaluate the submission to accept for filing and determine the review timeline.
−Removed: The FDA has stated that it expected
−Removed: all corrections to facility deficiencies to be complete at the time of resubmission so that all corrective actions may be verified during
−Removed: an onsite evaluation of the manufacturing facility in the next review cycle, if the FDA determines it will do an onsite evaluation.
−Removed: an onsite inspection is required, the Company may encounter delays in obtaining FDA approval because the FDA is currently facing a backlog
−Removed: due to the COVID-19 pandemic.
−Removed: The FDA issued a guidance document on its plan to use voluntary remote interactive evaluations at facilities,
−Removed: including for a pre-approval inspection to assess a marketing application.
−Removed: The FDA will request the manufacturing facility to participate
−Removed: in a voluntary remote interactive evaluation, if the FDA believes it is appropriate.
−Removed: A manufacturing facility cannot request the remote
−Removed: The FDA expects the use of remote interactive evaluations should help the FDA operate within normal timeframes in spite
−Removed: of the COVID-19 pandemic.
−Removed: The Company intends to pursue additional indications
−Removed: for DefenCath use as a CLS in populations with an unmet medical need that also represent potentially significant market opportunities.
−Removed: While the Company is continuing to assess these areas, potential future indications may include use as a CLS to reduce CRBSIs in total
−Removed: parenteral nutrition patients using a central venous catheter and in oncology patients using a central venous catheter.
−Removed: In addition to DefenCath, the Company is sponsoring
−Removed: a pre-clinical research collaboration for the use of taurolidine as a possible treatment for rare orphan pediatric tumors.
−Removed: 2018, the FDA granted orphan drug designation to taurolidine for the treatment of neuroblastoma in children.
−Removed: The Company may seek one
−Removed: or more strategic partners or other sources of capital to help develop and commercialize taurolidine for the treatment of neuroblastoma
−Removed: The Company is also evaluating opportunities for the possible expansion of taurolidine as a platform compound for use in
−Removed: certain medical devices.
−Removed: Patent applications have been filed in several indications, including wound closure, surgical meshes, and wound
−Removed: Based on initial feasibility work, the Company is advancing pre-clinical studies for taurolidine-infused surgical meshes,
−Removed: suture materials and hydrogels.
−Removed: The Company will seek to establish development/commercial partnerships as these programs advance.
−Removed: CORMEDIX INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
−Removed: The Company was granted a deferral by the FDA
−Removed: under the Pediatric Research Equity Act (“PREA”), that requires sponsors to conduct pediatric studies for NDAs for a new
−Removed: active ingredient, such as taurolidine in DefenCath, unless a waiver or deferral is obtained from the FDA.
−Removed: A deferral acknowledges that
−Removed: a pediatric assessment is required but permits the applicant to submit the pediatric assessment after the submission of an NDA.
−Removed: has made a commitment to conduct the pediatric study after approval of the NDA for use in adult hemodialysis patients.
−Removed: Pediatric studies
−Removed: for an approved product conducted under PREA may qualify for pediatric exclusivity, which if granted would provide an additional six
−Removed: months of marketing exclusivity.
−Removed: DefenCath would then have the potential to receive a total marketing exclusivity period of 10.5 years,
−Removed: including exclusivity pursuant to NCE and QIDP.
−Removed: The FDA regards taurolidine as a new chemical
−Removed: entity and therefore, it is currently an unapproved new drug.
−Removed: The Company might in the future pursue product candidates that would involve
−Removed: devices impregnated with taurolidine, and the Company believes that at the current time such products would be combination products subject
−Removed: to device premarket submission requirements (while subject also, under review by the FDA, to the standards for drug approvability).
−Removed: Consequently,
−Removed: given that there is no appropriate predicate medical device currently marketed in the U.S.
−Removed: on which a 510(k) approval process could be
−Removed: based and that taurolidine is not yet approved in any application, the Company anticipates that it would be required to submit a premarket
−Removed: approval application (“PMA”) for marketing authorization for any medical device indications that we may pursue for devices
−Removed: containing taurolidine.
−Removed: In the event that an NDA for DefenCath is approved by the FDA, the regulatory pathway for these medical device
−Removed: product candidates may be revisited with the FDA.
−Removed: Although there may be no appropriate predicate, de novo Class II designation can be
−Removed: proposed, based on a risk assessment and a reasonable assurance of safety and effectiveness.
−Removed: In the European Union (“EU”), Neutrolin
−Removed: is regulated as a Class 3 medical device.
−Removed: In July 2013, the Company received CE Mark approval for Neutrolin.
−Removed: In December 2013, the Company
−Removed: commercially launched Neutrolin in Germany for the prevention of CRBSI, and maintenance of catheter patency in hemodialysis patients using
−Removed: a tunneled, cuffed central venous catheter for vascular access.
−Removed: To date, Neutrolin is registered and may be sold in certain European Union
−Removed: countries for such treatment.
−Removed: In September 2014, the TUV-SUD and The Medicines
−Removed: Evaluation Board of the Netherlands (“MEB”), granted a label expansion for Neutrolin to include use in oncology patients
−Removed: receiving chemotherapy, intravenous (“IV”) hydration and IV medications via CVC for the EU.
−Removed: In December 2014, the Company
−Removed: received approval from the Hessian District President in Germany to expand the label for these same expanded indications.
−Removed: The expansion
−Removed: also adds patients receiving medication and IV fluids via CVC in intensive or critical care units (cardiac care unit, surgical care unit,
−Removed: neonatal critical care unit, and urgent care centers).
−Removed: An indication for use in total parenteral nutrition was also approved.
−Removed: In September 2019, the Company’s registration
−Removed: with the Saudi Arabia Food and Drug Administration, or the SFDA, expired.
−Removed: As a result, the Company cannot sell Neutrolin in Saudi Arabia.
−Removed: The Company intends to complete the documentation required to renew its registration with the SFDA, however, the Company cannot predict
−Removed: how long the renewal process will take.
−Removed: There is no assurance that the registration will be renewed by the SFDA.
+Added: proprietary name conditionally approved by the
+Added: Food and Drug Administration (“FDA”), while the name Neutrolin was used in the European Union (“EU”) and
+Added: other territories where the Company has received CE-Mark approval for the commercial distribution of Neutrolin as a catheter lock solution
+Added: (“CLS”) regulated as a medical device.
+Added: Note 2 — Liquidity and Uncertainties:
+Added: The consolidated financial statements have
+Added: been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”) which
+Added: contemplate continuation of the Company as a going concern.
+Added: To date, the Company’s commercial operations have not generated
+Added: sufficient revenues to enable profitability.
+Added: Company’s current development plans for DefenCath/Neutrolin in both the U.S.
+Added: and foreign markets and its other operating
+Added: requirements, the Company’s existing cash and cash equivalents and short-term investments at December 31, 2022 are expected to
+Added: fund its operations for at least twelve months from the issuance of this Annual Report on Form 10-K, after taking into consideration
+Added: the costs for resubmission of the NDA and initial preparations for the commercial launch for DefenCath.
CORMEDIX INC.
1 unchanged sentence
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
−Removed: Note 2 — Liquidity and Uncertainties:
−Removed: The consolidated financial statements have been
−Removed: prepared in conformity with generally accepted accounting principles which contemplate continuation of the Company as a going concern.
−Removed: To date, the Company’s commercial operations have not generated sufficient revenues to enable profitability.
−Removed: As of December 31,
−Removed: 2021, the Company had an accumulated deficit of $ 245.7 million, and incurred net losses of $ 28.2 million and $ 22.0 million for the years
−Removed: ended December 31, 2021 and 2020, respectively.
−Removed: Based on the Company’s current development plans for DefenCath/Neutrolin in both
−Removed: and foreign markets and its other operating requirements, the Company’s existing cash and cash equivalents and short-term
−Removed: investments at December 31, 2021 are expected to fund its operations at least through the first half of 2023, after taking into consideration
−Removed: the costs for resubmission of the NDA and initial preparations for the commercial launch for DefenCath.
−Removed: The Company’s continued operations will
−Removed: depend on its ability to raise additional capital through various potential sources, such as equity and/or debt financings, strategic
−Removed: relationships, potential strategic transactions or out-licensing of its products in order to commercially launch DefenCath upon NDA approval
−Removed: and until profitability is achieved, if ever.
−Removed: Management can provide no assurances that such financing or strategic relationships will
−Removed: be available on acceptable terms, or at all.
−Removed: As of December 31, 2021, the Company has $ 50.0 million available under its At-the-Market
−Removed: Issuance Sales Agreement (the “ATM program”) and has $ 150.0 million available under its current shelf registration for the
−Removed: issuance of equity, debt or equity-linked securities (see Note 7).
−Removed: The Company’s operations are subject to
−Removed: a number of other factors that can affect its operating results and financial condition.
+Added: The Company’s continued operations will depend
+Added: on its ability to raise additional capital through various potential sources, such as equity and/or debt financings, strategic relationships,
+Added: potential strategic transactions or out-licensing of its products in order to commercially launch DefenCath upon NDA approval and until
+Added: profitability is achieved, if ever.
+Added: Management can provide no assurances that such financing or strategic relationships will be available
+Added: on acceptable terms, or at all.
+Added: As of December 31, 2022, the Company has $ 50.0 million available under its At-the-Market Issuance Sales
+Added: Agreement (the “ATM program”) and has $ 150.0 million available under its current shelf registration for the issuance of equity,
+Added: debt or equity-linked securities (see Note 9).
+Added: The Company’s operations are subject to a
+Added: number of other factors that can affect its operating results and financial condition.
Such factors include, but are not limited to:
−Removed: the results of clinical testing and trial activities of the Company’s product candidates;
+Added: results of clinical testing and trial activities of the Company’s product candidates;
the ability to obtain regulatory approval
7 unchanged sentences
and the Company’s ability to raise capital to support its operations.
−Removed: The novel coronavirus has been declared a pandemic and has spread to
−Removed: multiple global regions.
−Removed: The outbreak and government measures taken in response have also had a significant impact, both direct and indirect,
−Removed: on businesses and commerce, as worker shortages have occurred;
−Removed: supply chains have been disrupted;
−Removed: facilities and production have been
−Removed: and demand for certain goods and services, such as medical services and supplies, has spiked, while demand for other goods
−Removed: and services, such as travel, has fallen.
−Removed: In response to the COVID-19 outbreak, “shelter in place” orders and other public
−Removed: health guidance measures have been implemented across much of the United States, Europe and Asia, including in the locations of the Company’s
−Removed: offices, clinical trial sites, key vendors and partners.
−Removed: The Company’s program timelines may be negatively affected by COVID-19,
−Removed: which could materially and adversely affect its business, financial conditions and results of operations.
Note 3 — Summary of Significant Accounting Policies:
1 unchanged sentence
The preparation of financial
−Removed: statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates
+Added: statements in conformity with GAAP requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the
2 unchanged sentences
from those estimates.
−Removed: Reclassifications
−Removed: Certain reclassifications were made to the prior
−Removed: year’s amounts to conform to the 2021 presentation.
−Removed: Non-cash lease expense, as presented on the Company’s consolidated statement
−Removed: of cash flows for the year ended December 31, 2020, is now presented as change in right-of-use assets and change in operating lease liabilities.
Basis of Consolidation
4 unchanged sentences
accounts and transactions have been eliminated in consolidation.
−Removed: CORMEDIX INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
Financial Instruments
−Removed: Financial instruments that potentially
−Removed: subject the Company to concentrations of credit risk consist principally of cash and cash equivalents and short-term investments.
−Removed: Company maintains its cash and cash equivalents in bank deposit and other interest-bearing accounts, the balances of which, at times,
−Removed: may exceed federally insured limits.
+Added: Financial instruments that potentially subject
+Added: the Company to concentrations of credit risk consist principally of cash and cash equivalents and short-term investments.
+Added: maintains its cash and cash equivalents in bank deposit and other interest-bearing accounts, the balances of which exceed federally insured
The following table is the reconciliation
4 unchanged sentences
Total cash, cash equivalents and restricted cash
+Added: CORMEDIX INC.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
The appropriate classification of marketable securities
15 unchanged sentences
at December 31, 2022 or 2021.
−Removed: The Company’s marketable securities are
−Removed: highly liquid and consist of U.S.
+Added: The Company’s marketable securities are highly
+Added: liquid and consist of U.S.
government agency securities, high-grade corporate obligations and commercial paper with original maturities
of more than 90 days.
−Removed: As of December 31, 2021 and 2020, all of the Company’s investments had contractual maturities which were
−Removed: less than one year.
+Added: As of December 31, 2022 and 2021, all of the Company’s investments had contractual maturities which were less
+Added: than one year.
The following table summarizes the amortized cost, unrealized gains and losses and the fair value at December 31, 2022
−Removed: 2021 and 2020:
December 31, 2022:
+Added: Gross Unrealized
Money Market Funds and Cash Equivalents
5 unchanged sentences
Money Market Funds and Cash Equivalents
+Added: Government Agency Securities
Corporate Securities
1 unchanged sentence
Total December 31, 2021
+Added: Fair Value Measurements
+Added: The Company’s financial instruments
+Added: recorded in the consolidated balance sheets include cash and cash equivalents, accounts receivable, investment securities and
+Added: accounts payable.
+Added: The carrying value of certain financial instruments, primarily cash and cash equivalents,
+Added: accounts receivable, accounts payable, and accrued expenses approximate their estimated fair values based upon the short-term nature
+Added: of their maturity dates.
+Added: The Company categorizes its financial instruments
+Added: into a three-level fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value, which is set out
+Added: The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets (Level 1) and the lowest
+Added: priority to unobservable inputs (Level 3).
+Added: If the inputs used to measure fair value fall within different levels of the hierarchy, the
+Added: category level is based on the lowest priority level input that is significant to the fair value measurement of the instrument.
+Added: ● Level 1 inputs—Observable inputs that reflect quoted
+Added: prices (unadjusted) for identical assets or liabilities in active markets.
+Added: ● Level 2 inputs— Significant other observable inputs
+Added: (e.g., quoted prices for similar items in active markets, quoted prices for identical or similar items in markets that are not active,
+Added: inputs other than quoted prices that are observable such as interest rate and yield curves, and market-corroborated inputs).
+Added: ● Level 3 inputs—Unobservable inputs for the asset or
+Added: liability, which are supported by little or no market activity and are valued based on management’s estimates of assumptions that
+Added: market participants would use in pricing the asset or liability.
CORMEDIX INC.
1 unchanged sentence
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
−Removed: Fair Value Measurements
−Removed: The Company’s financial instruments recorded
−Removed: in the consolidated balance sheets include cash and cash equivalents, accounts receivable, investment securities, accounts payable and
−Removed: accrued expenses.
−Removed: The carrying value of certain financial instruments, primarily cash and cash equivalents, accounts receivable,
−Removed: accounts payable, and accrued expenses approximate their estimated fair values based upon the short-term nature of their maturity dates.
−Removed: The Company’s senior secured convertible note (prior to its extinguishment in August 2019) falls into the Level 3 category within
−Removed: the fair value level hierarchy.
−Removed: The fair value was determined using market data for valuation.
−Removed: The Company categorizes its financial instruments
−Removed: into a three-level fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value, which is set
−Removed: The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets (Level 1) and
−Removed: the lowest priority to unobservable inputs (Level 3).
−Removed: If the inputs used to measure fair value fall within different levels of the hierarchy,
−Removed: the category level is based on the lowest priority level input that is significant to the fair value measurement of the instrument.
−Removed: ● Level 1 inputs—Observable inputs that reflect quoted prices
−Removed: (unadjusted) for identical assets or liabilities in active markets.
−Removed: ● Level 2 inputs— Significant other observable inputs (e.g.,
−Removed: quoted prices for similar items in active markets, quoted prices for identical or similar items in markets that are not active, inputs
−Removed: other than quoted prices that are observable such as interest rate and yield curves, and market-corroborated inputs).
−Removed: ● Level 3 inputs—Unobservable inputs for the asset or liability,
−Removed: which are supported by little or no market activity and are valued based on management’s estimates of assumptions that market participants
−Removed: would use in pricing the asset or liability.
The following table provides the carrying value
8 unchanged sentences
December 31, 2021:
−Removed: Money Market Funds and Cash
+Added: Money Market Funds and Cash Equivalents
+Added: Government Agency Securities
Corporate Securities
1 unchanged sentence
Total December 31, 2021
−Removed: CORMEDIX INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
Foreign Currency Translation and Transactions
7 unchanged sentences
and losses are included in other comprehensive income (loss).
−Removed: The Company had a foreign currency translation loss of $ 10,221 in 2021 and
−Removed: a gain of $ 6,020 in 2020.
+Added: The Company had a foreign currency translation loss of $ 9,442 and $ 10,221
+Added: for the year ended December 31, 2022 and 2021, respectively.
Foreign currency exchange transaction gain (loss)
is the result of re-measuring transactions denominated in a currency other than the functional currency of the entity recording the transaction.
−Removed: Geographic Information
−Removed: The following table summarizes the geographic
−Removed: Reported revenues
−Removed: Revenues attributable to European and Mideast operations, which are based in Germany
−Removed: Total assets located in the United States, with the remainder in the European Union
Restricted Cash
−Removed: As of December 31, 2021, and 2020 the Company
−Removed: has restricted cash in connection with the patent and utility model infringement proceedings against TauroPharm (see Note 7).
−Removed: Company was required by the District Courts of Mannheim to provide security deposit to cover legal fees in the event TauroPharm is entitled
−Removed: to reimbursement of these costs.
−Removed: The Company furthermore had to provide a deposit for the first and second instances, respectively, in
−Removed: connection with the unfair competition proceedings in Cologne.
−Removed: During the year ended December 31, 2021, approximately $ 48,000 was released
−Removed: by the court for the reimbursement of legal fees and other costs which was removed from restricted cash.
−Removed: As of December 31, 2021 and
−Removed: 2020, restricted cash in connection with the patent and utility model infringement proceedings were $ 132,000 and $ 191,000 , respectively.
+Added: As of December 31, 2022, and 2021 the Company has
+Added: restricted cash in connection with the patent and utility model infringement proceedings against TauroPharm (see Note 8).
+Added: was required by the District Courts of Mannheim to provide security deposit to cover legal fees in the event TauroPharm is entitled to
+Added: reimbursement of these costs.
+Added: The Company furthermore had to provide a deposit for the first and second instances, respectively, in connection
+Added: with the unfair competition proceedings in Cologne.
+Added: During the year ended December 31, 2021, approximately $ 48,000 was released by the
+Added: court for the reimbursement of legal fees and other costs which was removed from restricted cash.
+Added: As of December 31, 2022 and 2021, restricted
+Added: cash in connection with the patent and utility model infringement proceedings were $ 124,000 and $ 132,000 , respectively.
As of December 31, 2022, the Company had $ 102,000
in long-term restricted cash for a lease security deposit.
+Added: CORMEDIX INC.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
Prepaid Research and Development and Other Prepaid Expenses
−Removed: Prepaid expenses consist of
−Removed: payments made in advance to vendors relating to service contracts for clinical trial development, manufacturing, pre-clinical development
−Removed: and insurance policies.
−Removed: These advanced payments are amortized to expense either as services are performed or over the relevant service
−Removed: period using the straight-line method.
+Added: Prepaid expenses consist of payments
+Added: made in advance to vendors relating to service contracts for clinical trial development, manufacturing, pre-clinical development and insurance
+Added: These advanced payments are amortized to expense either as services are performed or over the relevant service period using
+Added: the straight-line method.
Inventories are valued at the lower of cost or
4 unchanged sentences
Finished goods
−Removed: CORMEDIX INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
Property and Equipment
−Removed: Property and equipment consist primarily of furnishings,
−Removed: fixtures, leasehold improvements, office equipment and computer equipment all of which are recorded at cost.
−Removed: Depreciation is provided
−Removed: for by the straight-line method over the estimated useful lives of the related assets.
−Removed: Leasehold improvements are amortized
−Removed: using the straight-line method over the remaining lease term or the life of the asset, whichever is shorter.
−Removed: Property and equipment,
−Removed: as of December 31, 2021 and 2020 were $ 1,474,937 and $ 111,499 , respectively, net of accumulated depreciation of $ 365,169 and $ 303,279 ,
−Removed: respectively.
−Removed: Depreciation and amortization of property and equipment is included in selling, general and administrative expenses.
+Added: Property and equipment consist
+Added: primarily of furnishings, fixtures, leasehold improvements, office equipment and computer equipment all of which are recorded at cost.
+Added: Depreciation is provided for by the straight-line method over the estimated useful lives of the related assets.
+Added: Leasehold improvements
+Added: are amortized using the straight-line method over the remaining lease term or the life of the asset, whichever is shorter.
+Added: and equipment, as of December 31, 2022 and 2021 were $ 1,609,679 and $ 1,474,937 , respectively, net of accumulated depreciation of $ 449,787
+Added: and $ 365,169 , respectively.
+Added: Depreciation and amortization of property and equipment is included in selling, general and administrative
Estimated Useful Life
1 unchanged sentence
Leasehold improvements
+Added: 7 years or remaining term of the lease
Computer equipment
2 unchanged sentences
Operating leases are included in operating lease right-of-use (“ROU”)
−Removed: assets, current portion of operating lease liabilities (included in accrued expenses), and operating lease liabilities, net of current
+Added: assets, current portion of operating lease liabilities, and operating lease liabilities, net of current
portion, on the consolidated balance sheet (see Note 11).
6 unchanged sentences
may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option.
−Removed: expense for minimum lease payments is recognized on a straight-line basis over the lease term.
+Added: Lease expense
+Added: for minimum lease payments is recognized on a straight-line basis over the lease term.
Company has elected, as an accounting policy, not to apply the recognition requirements in ASC 842 to short-term leases.
4 unchanged sentences
over the lease term.
+Added: CORMEDIX INC.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
Company has also elected, as a practical expedient, by underlying class of asset, not to separate lease components from non-lease components
and, instead, account for them as a single component.
−Removed: Accrued Expenses
−Removed: Accrued expenses consist
−Removed: of the following:
−Removed: Professional and consulting fees
−Removed: Accrued payroll and payroll taxes
−Removed: Manufacturing development related
Revenue Recognition
6 unchanged sentences
and (v) recognizing
−Removed: CORMEDIX INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
The Company recognizes net sales upon shipment
of product to the dialysis centers and upon meeting the five-step model prescribed by ASC 606 outlined above.
−Removed: Deferred Revenue
−Removed: In August 2014, the Company entered into an exclusive
−Removed: distribution agreement (the “Wonik Agreement”) with Wonik Corporation, a South Korean company, to market, sell and distribute
−Removed: Neutrolin for hemodialysis and oncolytic patients upon receipt of regulatory approval in South Korea.
−Removed: Upon execution, Wonik paid the
−Removed: Company a non-refundable $ 50,000 payment and will pay an additional $ 50,000 upon receipt of the product registration necessary to sell
−Removed: Neutrolin in South Korea (the “Territory”).
−Removed: The term of the Wonik Agreement commenced on August 8, 2014 and will continue
−Removed: for three years after the first commercial sale of Neutrolin in the Territory.
−Removed: The non-refundable up-front payment has been recorded
−Removed: as deferred revenue and will be recognized as revenue on a straight-line basis over the contractual term of the Agreement.
−Removed: Deferred revenue
−Removed: related to this agreement was fully amortized at December 31, 2020.
Loss Per Common Share
−Removed: Basic loss per common share
−Removed: excludes dilution and is computed by dividing net loss by the weighted average number of common shares outstanding during the period.
−Removed: Diluted loss per common share reflects the potential dilution that could occur if securities or other contracts to issue common stock
−Removed: were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the entity.
+Added: Basic loss per common share excludes
+Added: dilution and is computed by dividing net loss by the weighted average number of common shares outstanding during the period.
+Added: per common share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised
+Added: or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the entity.
The Company’s outstanding shares of Series E preferred
2 unchanged sentences
Series E preferred stock meet the definition of participating securities requiring the application of the two-class method.
−Removed: two-class method, earnings available to common shareholders, including both distributed and undistributed earnings, are allocated to
−Removed: each class of common stock and participating securities according to dividends declared and participating rights in undistributed earnings,
+Added: two-class method, earnings available to common shareholders, including both distributed and undistributed earnings, are allocated to each
+Added: class of common stock and participating securities according to dividends declared and participating rights in undistributed earnings,
which may cause diluted earnings per share to be more dilutive than the calculation using the treasury stock method.
6 unchanged sentences
from the calculation of diluted net loss per share due to their anti-dilutive effect:
−Removed: Number of Shares of
−Removed: Common Stock Issuable At
+Added: Number of Shares of Common Stock Issuable At
Series C non-voting preferred stock
4 unchanged sentences
Shares underlying outstanding stock options
+Added: Restricted stock units
Total potentially dilutive shares
+Added: CORMEDIX INC.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
Stock-Based Compensation
5 unchanged sentences
using the Monte Carlo option pricing model and the expense is recognized over the derived service period.
−Removed: CORMEDIX INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
Research and Development
1 unchanged sentence
are charged to expense as incurred.
−Removed: Research and development include fees associated with operational consultants, contract clinical
−Removed: research organizations, contract manufacturing organizations, clinical site fees, contract laboratory research organizations, contract
−Removed: central testing laboratories, licensing activities, and allocated executive, human resources and facilities expenses.
−Removed: The Company accrues
−Removed: for costs incurred as the services are being provided by monitoring the status of the trial and the invoices received from its external
−Removed: service providers.
+Added: Research and development include fees associated with operational consultants, contract clinical research
+Added: organizations, contract manufacturing organizations, clinical site fees, contract laboratory research organizations, contract central
+Added: testing laboratories, licensing activities, and allocated executive, human resources and facilities expenses.
+Added: The Company accrues for
+Added: costs incurred as the services are being provided by monitoring the status of the trial and the invoices received from its external service
As actual costs become known, the Company adjusts its accruals in the period when actual costs become known.
−Removed: related to the acquisition of technology rights and patents for which development work is still in process are charged to operations
−Removed: as incurred and considered a component of research and development expense.
+Added: Costs related
+Added: to the acquisition of technology rights and patents for which development work is still in process are charged to operations as incurred
+Added: and considered a component of research and development expense.
tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial
7 unchanged sentences
tax assets will not be realized.
−Removed: Recently Adopted Authoritative Pronouncements
−Removed: In June 2016, the Financial Accounting Standards
−Removed: Board (“FASB”) issued new guidance which replaces the incurred loss impairment methodology in current GAAP with a methodology
−Removed: that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform
−Removed: credit loss estimates.
−Removed: This adoption on January 1, 2020 did not have a material impact on the Company’s consolidated financial
−Removed: In August 2018, the FASB issued new guidance which
−Removed: modifies the disclosure requirements on fair value measurements.
−Removed: The guidance was effective for the Company beginning in the first quarter
−Removed: of fiscal year 2020.
−Removed: This adoption on January 1, 2020 did not have a material impact on the Company’s consolidated financial statements.
−Removed: In November 2018, the FASB issued new guidance
−Removed: to clarify the interaction between the authoritative guidance for collaborative arrangements and revenue from contracts with customers.
−Removed: The new guidance clarifies that, when the collaborative arrangement participant is a customer in the context of a unit-of-account, revenue
−Removed: from contracts with customers guidance should be applied, adds unit-of-account guidance to collaborative arrangements guidance, and,
−Removed: in a transaction with a collaborative arrangement participant who is not a customer, precludes presenting the transaction together with
−Removed: revenue recognized under contracts with customers.
−Removed: The guidance was effective for the Company beginning in the first quarter of fiscal
−Removed: This adoption on January 1, 2020 did not have a material impact on the Company’s consolidated financial statements.
−Removed: In November 2019, the FASB issued new guidance
−Removed: which requires that an entity measure and classify share-based payment awards granted to a customer by applying the guidance in FASB
−Removed: The guidance was effective for the Company beginning in the first quarter of fiscal year 2020.
−Removed: This adoption on January 1, 2020
−Removed: did not have a material impact on the Company’s consolidated financial statements.
−Removed: In December 2019, the FASB issued ASU 2019-12
−Removed: which removes certain exceptions to the general principles of the accounting for income taxes and also improves consistent application
−Removed: of and simplification of other areas when accounting for income taxes.
−Removed: The guidance was effective for the Company beginning in the first
−Removed: quarter of fiscal year 2021.
−Removed: Early adoption was permitted.
−Removed: This adoption on January 1, 2021 did not have a material impact on the Company’s
−Removed: consolidated financial statements.
−Removed: CORMEDIX INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
+Added: The Company records legal
+Added: costs associated with loss contingencies when they are probable and reasonably estimable.
+Added: Note 4 — Geographic Information:
+Added: Geographic Information
+Added: The following table summarizes the geographic information:
+Added: Reported revenues
+Added: Revenues attributable to European and Mideast operations, which are based in Germany
+Added: Total assets located in the United States, with the remainder in the European Union
+Added: Note 5 — Accrued Expenses:
+Added: Accrued Expenses
+Added: Accrued expenses consist of
+Added: the following:
+Added: Professional and consulting fees
+Added: Accrued payroll and payroll taxes
+Added: Manufacturing development related
Note 6 — Related Party Transactions:
1 unchanged sentence
Elliott Associates LP and Elliott International LP (collectively, “Elliott”), an existing institutional investor who collectively
−Removed: beneficially own the largest portion of the Company’s common stock, converted an aggregate of 10,001 Series G preferred shares
−Removed: into an aggregate of 556,069 shares of the Company’s common stock.
+Added: beneficially own the largest portion of the Company’s common stock, converted an aggregate of 10,001 Series G preferred shares into
+Added: an aggregate of 556,069 shares of the Company’s common stock.
+Added: CORMEDIX INC.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
Note 7 — Income Taxes:
7 unchanged sentences
$ ( 29,460,412 )
−Removed: There were no current or deferred income tax provision
+Added: There were no current or deferred income tax provisions
for the years ended December 31, 2022 and 2021 because the Company has incurred operating losses since inception.
7 unchanged sentences
Accrued compensation
+Added: Section 174 capitalization
Less valuation allowance
6 unchanged sentences
$ 209,930,000
−Removed: The net operating losses generated will start
−Removed: to expire in 2026 for Federal purposes whereas the operating losses for state purposes will begin expiring in 2038.
−Removed: The Tax Cuts and
−Removed: Jobs Act of 2017 (the “Act”) limits the net operating loss deduction to 80 % of taxable income for losses arising in tax years
−Removed: beginning after December 31, 2017.
−Removed: However, the net operating losses now have an indefinite carryforward as opposed to the former
−Removed: 20-year carryforward.
+Added: The net operating losses generated will start to
+Added: expire in 2026 for Federal purposes whereas the operating losses for state purposes will begin expiring in 2040.
+Added: The Tax Cuts and Jobs
+Added: Act of 2017 (the “Act”) limits the net operating loss deduction to 80 % of taxable income for losses arising in tax years beginning
+Added: after December 31, 2017.
+Added: However, the net operating losses now have an indefinite carryforward as opposed to the former 20-year
+Added: carryforward.
The foreign net operating loss tax carryforwards do not expire.
1 unchanged sentence
include windfall tax deductions from stock option exercises.
+Added: The utilization of the Company’s net operating losses may be
+Added: subject to a substantial limitation due to the “change of ownership provisions” under Section 382 of the Internal Revenue
+Added: Code and similar state provisions.
+Added: Such limitation may result in the expiration of the net operating loss carryforwards before their utilization.
During 2021, the Company’s German subsidiary
7 unchanged sentences
The foreign net operating loss carryforward relates to the Company’s Spanish subsidiary.
−Removed: The utilization of the Company’s net operating
−Removed: losses may be subject to a substantial limitation due to the “change of ownership provisions” under Section 382 of the Internal
−Removed: Revenue Code and similar state provisions.
−Removed: Such limitation may result in the expiration of the net operating loss carryforwards before
−Removed: their utilization.
+Added: CORMEDIX INC.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
The Company’s foreign earnings are derived
2 unchanged sentences
in the near future.
−Removed: CORMEDIX INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
−Removed: The Company’s effective tax rate varied
−Removed: from the statutory rate as follows:
+Added: in May 2022, the Company began the process of winding down its operations in the EU and expects to derive no income after the end of 2022.
+Added: The Company’s effective tax rate varied from
+Added: the statutory rate as follows:
Statutory federal tax rate
State income tax rate (net of federal)
−Removed: Effect of foreign operations
Change in foreign NOL
6 unchanged sentences
The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income of the appropriate character
−Removed: during the periods in which those temporary differences become deductible and the loss carryforwards are available to reduce taxable
−Removed: In making its assessment, the Company considered all sources of taxable income including carryback potential, future reversals
−Removed: of existing deferred tax liabilities, prudent and feasible tax planning strategies, and lastly, objectively verifiable projections of
−Removed: future taxable income exclusive of reversing temporary differences and carryforwards.
−Removed: At December 31, 2021 and 2020, the Company maintained
−Removed: a full valuation allowance against its net deferred tax assets.
−Removed: The Company will continue to assess all available evidence during future
−Removed: periods to evaluate the realization of its deferred tax assets.
+Added: during the periods in which those temporary differences become deductible and the loss carryforwards are available to reduce taxable income.
+Added: In making its assessment, the Company considered all sources of taxable income including carryback potential, future reversals of existing
+Added: deferred tax liabilities, prudent and feasible tax planning strategies, and lastly, objectively verifiable projections of future taxable
+Added: income exclusive of reversing temporary differences and carryforwards.
+Added: At December 31, 2022 and 2021, the Company maintained a full valuation
+Added: allowance against its net deferred tax assets.
+Added: The Company will continue to assess all available evidence during future periods to evaluate
+Added: the realization of its deferred tax assets.
The following table presents the changes in the
deferred tax asset valuation allowance for the periods indicated:
−Removed: (Credited) to
+Added: Balance at Beginning of
+Added: Increase (Decrease) Charged (Credited) to
+Added: Income Taxes (Benefit)
+Added: Increase (Decrease) Charged (Credited)
+Added: Balance at End of
December 31, 2022
2 unchanged sentences
uncertain tax positions to be classified as non-current income tax liabilities unless they are expected to be paid within one year.
−Removed: Company has concluded that there are no uncertain tax positions requiring recognition in its consolidated financial statements as of
−Removed: December 31, 2021 and 2020.
−Removed: The Company recognizes interest and penalties related to uncertain tax positions if any as a component of
−Removed: income tax expense.
+Added: Company has concluded that there are no uncertain tax positions requiring recognition in its consolidated financial statements as of December
+Added: 31, 2022 and 2021.
+Added: The Company recognizes interest and penalties related to uncertain tax positions if any as a component of income tax
The Company files U.S.
2 unchanged sentences
federal, state and local
−Removed: perspective the years that remains open to examination are consistent with each jurisdiction’s statute of limitations.
+Added: perspective the years that remain open to examination are consistent with each jurisdiction’s statute of limitations.
From a foreign
1 unchanged sentence
During the years ended December 31, 2022 and 2021,
−Removed: the Company received net proceeds of $ 1,250,186 and $ 5,169,395 , respectively, from the sale of most of its remaining unused New Jersey
−Removed: net operating losses (“NOL”) eligible for sale under the State of New Jersey’s Economic Development Authority’s
−Removed: New Jersey Technology Business Tax Certificate Transfer program (“NJEDA Program”).
−Removed: The NJEDA Program allowed the Company
−Removed: to sell $ 1,337,000 of its total $ 1,337,000 in available NOL tax benefits for the state fiscal year 2020 and $ 5,529,000 of its total $ 6,018,000
−Removed: for the state fiscal year 2019.
+Added: the Company received net proceeds of $ 586,000 and $ 1,250,000 , respectively, from the sale of most of its remaining unused New Jersey net
+Added: operating losses (“NOL”) eligible for sale under the State of New Jersey’s Economic Development Authority’s New
+Added: Jersey Technology Business Tax Certificate Transfer program (“NJEDA Program”).
+Added: The NJEDA Program allowed the Company to sell
+Added: $ 626,000 of its total $ 626,000 in available NOL tax benefits for the state fiscal year 2021 and $ 1,337,000 of its total $ 1,337,000 for
+Added: the state fiscal year 2020.
CORMEDIX INC.
6 unchanged sentences
Securities Litigation, Case No.
−Removed: 2:21-cv014020-JXN-CLW,
−Removed: two putative class action lawsuits filed on or about July 22, 2021 and September 13, 2021, respectively, and appointed lead counsel and
−Removed: lead plaintiff, a purported stockholder of the Company.
+Added: 2:21-cv014020-JXN-CLW, two
+Added: putative class action lawsuits filed on or about July 22, 2021 and September 13, 2021, respectively, and appointed lead counsel and lead
+Added: plaintiff, a purported stockholder of the Company.
The lead plaintiff filed a consolidated amended class action complaint on December
1 unchanged sentence
11 and 15 of the Securities Act of 1933.
−Removed: The complaint names as defendants the Company, Khoso Baluch, Matthew David, Phoebe Mounts, John
−Removed: Armstrong, Robert Cook, Janet Dillione, Alan W.
−Removed: Dunton, Myron Kaplan, Steven Lefkowitz, Paulo F.
−Removed: Costa, and Greg Duncan, as well as
−Removed: two underwriters of the Company’s secondary stock offering, B.
−Removed: Riley Securities, Inc.
−Removed: and Needham & Company, LLC.
−Removed: The purported
−Removed: bases for these claims are alleged misstatements and omissions in connection with the NDA submitted to the FDA for DefenCath, and the
−Removed: subsequent notification by the FDA that the NDA could not be approved in its present form.
−Removed: The lead plaintiff purports to assert the Exchange
−Removed: Act claims on behalf of persons that purchased or otherwise acquired shares of the Company’s securities between October 16, 2019,
−Removed: and September 6, 2021, and purports to assert the Securities Act claims on behalf of persons that purchased shares of the Company’s
−Removed: securities pursuant or traceable to a secondary offering of stock that commenced on November 27, 2020.
−Removed: The Company intends to vigorously
−Removed: contest such claims and filed a motion to dismiss the current complaint in full, with prejudice, on February 21, 2022.
−Removed: As of this filing,
−Removed: the current schedule set by the Court requires the Company and the other defendants to refile their motion to dismiss on March 28, 2022,
−Removed: requires the lead plaintiff to file an opposition to the Company’s motion to dismiss on or before April 27, 2022 and requires that
−Removed: the Company file a reply on or before May 27, 2022.
+Added: On October 10, 2022, the lead plaintiff filed a second amended consolidated complaint that superseded
+Added: the original complaints in In re CorMedix Securities Litigation.
+Added: In the second amended complaint, the lead plaintiff seeks to represent
+Added: two classes of shareholders:
+Added: (i) shareholders who purchased or otherwise acquired CorMedix securities between October 16, 2019 and August
+Added: 8, 2022, inclusive;
+Added: and (ii) shareholders who purchased CorMedix securities pursuant or traceable to the Company’s November 27,
+Added: 2020 offering pursuant to CorMedix’s Form S-3 Registration Statement, its Prospectus Supplement, dated November 27, 2020, and its
+Added: Prospectus Supplement, dated August 12, 2021.
+Added: The second amended complaint names as defendants the Company and twelve (12) current and
+Added: former directors and officers of CorMedix, namely Khoso Baluch, Robert Cook, Matthew David, Phoebe Mounts, John L.
+Added: Armstrong, and Joseph
+Added: Todisco (the “Officer Defendants” and collectively with CorMedix, the “CorMedix Defendants”) as well as Janet
+Added: Dillione, Myron Kaplan, Alan W.
+Added: Dunton, Steven Lefkowitz, Paulo F.
+Added: Costa, Greg Duncan (the “Director Defendants”).
+Added: amended complaint alleges that the CorMedix Defendants violated Section 10(b) of the Exchange Act (and Rule 10b-5), the Officer Defendants
+Added: violated Section 20(a), the Director Defendants, CorMedix, Baluch, and David violated Section 11 of the Securities Act, and that the Director
+Added: Defendants, Baluch, and David violated Section 15.
+Added: In general, the purported bases for these claims are allegedly false and misleading
+Added: statements and omissions related to the NDA submissions to the FDA for DefenCath, subsequent complete response letters, as well as communications
+Added: from the FDA related and directed to the Company’s contract manufacturing organization and heparin supplier.
+Added: The Company intends
+Added: to vigorously contest such claims.
+Added: The Company and the other Defendants filed their motion to dismiss the second amended complaint on
+Added: November 23, 2022;
+Added: the lead plaintiff filed his opposition to the Defendants’ motions to dismiss on January 7, 2023;
+Added: and Defendants
+Added: filed their reply brief on February 6, 2023.
On or about October 13, 2021, a purported shareholder,
1 unchanged sentence
of New Jersey, in a case entitled Voter v.
+Added: Baluch, et al., Case No.
+Added: 2:21-cv-18493-JXN-LDW (the “Derivative Litigation”).
+Added: complaint names as defendants Khoso Baluch, Janet Dillione, Alan W.
+Added: Dunton, Myron Kaplan, Steven Lefkowitz, Paulo F.
+Added: Costa, Greg Duncan,
+Added: Matthew David, and Phoebe Mounts along with the Company as Nominal Defendant.
+Added: The complaint alleges breaches of fiduciary duties, abuse
+Added: of control, and waste of corporate assets against the defendants and a claim for contribution for purported violations of Sections 10(b)
+Added: and 21D of the Exchange Act against certain defendants.
+Added: The individual defendants intend to vigorously contest such claims.
+Added: 21, 2022, pursuant to a stipulation between the parties, the Court entered an order staying the case while the motion to dismiss the class
+Added: action lawsuit described in the foregoing paragraph is pending.
+Added: The stay may be terminated before the motion to dismiss is resolved according
+Added: to certain circumstances described in the stipulation available on the Court’s public docket.
+Added: The case was administratively terminated
+Added: on March 16, 2022 while the stay is pending.
+Added: On or about January 13, 2023, another purported
+Added: shareholder, derivatively and on behalf of the Company, filed a shareholder derivative complaint in the United States District Court for
+Added: the District of New Jersey, in a case entitled DeSalvo v.
+Added: Costa, et al.
+Added: 2:23-cv-00150-JXN-CLW.
+Added: Defendants Paulo F.
+Added: Dillione, Greg Duncan, Alan Dunton, Myron Kaplan, Steven Lefkowitz, Joseph Todisco, Khoso Baluch, Robert Cook, Matthew David,
+Added: Phoebe Mounts, and John L.
+Added: Armstrong along with the Company as Nominal Defendant.
+Added: The complaint alleges breaches of fiduciary duty and
+Added: unjust enrichment against the individual defendants.
+Added: The individual defendants intend to vigorously contest such claims.
+Added: The case is in
+Added: the early stages.
+Added: CORMEDIX INC.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
+Added: On or about January 25, 2023, another purported
+Added: shareholder, derivatively and on behalf of the Company, filed a shareholder derivative complaint in the United States District Court for
+Added: the District of New Jersey, in a case entitled Scullion v.
Baluch, et al.
−Removed: 2:21-cv-18493-JXN-LDW.
−Removed: The complaint names as defendants Khoso
−Removed: Baluch, Janet Dillione, Alan W.
+Added: 2:23-cv-00406-ES-ESK.
+Added: Defendants Khoso Baluch,
+Added: Janet Dillione, Alan W.
Dunton, Myron Kaplan, Steven Lefkowitz, Paulo F.
−Removed: Costa, Greg Duncan, Matthew David, and Phoebe Mounts
−Removed: along with the Company as Nominal Defendant.
−Removed: The complaint alleges breaches of fiduciary duties, abuse of control, and waste of
−Removed: corporate assets against the defendants and a claim for contribution for purported violations of Sections 10(b) and 21D of the Exchange
−Removed: Act against certain defendants.
−Removed: The Company intends to vigorously contest such claims.
−Removed: On January 21, 2022, pursuant to a stipulation
−Removed: between the parties, the Court entered an order staying the case while the motion to dismiss the class action lawsuit described in the
−Removed: foregoing paragraph is pending.
−Removed: The stay may be terminated before the motion to dismiss is resolved according to certain circumstances
−Removed: described in the stipulation available on the Court’s public docket.
+Added: Costa, Gregory Duncan, Matthew David, and Phoebe Mounts, along
+Added: with the Company as Nominal Defendant.
+Added: The complaint alleges breaches of fiduciary duties.
+Added: The individual defendants intend to vigorously
+Added: contest such claims.
+Added: The case is also in the early stages.
+Added: On or about June 23, 2022, the Company’s
+Added: Board received a letter demanding it investigate and pursue causes of action, purportedly on behalf of Company, against certain current
+Added: and former directors, officers, and/or other employees of the Company (the “Letter”), which the Board believes are duplicative
+Added: of the claims already asserted in the Derivative Litigation.
+Added: As set forth in the Board’s response to the Letter, the Board will
+Added: consider the Letter at an appropriate time, as circumstances warrant, as it continues to monitor the progress of the Derivative Litigation.
On September 9, 2014, the Company filed in the
−Removed: District Court of Mannheim, Germany, a patent infringement action against TauroPharm GmbH and Tauro-Implant GmbH as well as their respective
−Removed: CEOs (the “Defendants”) claiming infringement of the Company’s European Patent EP 1 814 562 B1, which was granted by
−Removed: the European Patent Office (the “EPO”) on January 8, 2014 (the “Prosl European Patent”).
−Removed: The Prosl European
−Removed: Patent covers the formulation of taurolidine and citrate with low dose heparin in a catheter lock solution for maintaining patency and
−Removed: preventing infection in hemodialysis catheters.
−Removed: In this action, the Company claims that the Defendants infringe on the Prosl European
−Removed: Patent by manufacturing and distributing catheter locking solutions to the extent they are covered by the claims of the Prosl European
−Removed: The Company believes that its patent is sound and is seeking injunctive relief and raising claims for information,
−Removed: rendering of accounts, calling back, destruction and damages.
−Removed: Separately, TauroPharm has filed an opposition with the EPO against the
−Removed: Prosl European Patent alleging that it lacks novelty and inventive step.
−Removed: The Company cannot predict the ultimate outcome of
−Removed: either of these related matters.
−Removed: At present, the EPO has revoked the Prosl European Patent as invalid, and the Company has filed an appeal,
−Removed: which is currently pending.
+Added: District Court of Mannheim, Germany, (the “Court”) a patent infringement action against TauroPharm GmbH and Tauro-Implant
+Added: GmbH as well as their respective CEOs (the “Defendants”) claiming infringement of the Company’s European Patent EP 1
+Added: 814 562 B1, which was granted by the European Patent Office (the “EPO”) on January 8, 2014 (the “Prosl European Patent”).
+Added: The Prosl European Patent covers the formulation of taurolidine and citrate with low dose heparin in a catheter lock solution for maintaining
+Added: patency and preventing infection in hemodialysis catheters.
+Added: In this action, the Company claims that the Defendants infringe on the Prosl
+Added: European Patent by manufacturing and distributing catheter locking solutions to the extent they are covered by the claims of the Prosl
+Added: European Patent.
+Added: The Company is seeking injunctive relief and raising claims for information, rendering of accounts, calling
+Added: back, destruction and damages.
+Added: Separately, TauroPharm has filed an opposition with the EPO against the Prosl European Patent alleging
+Added: that it lacks novelty and inventive step.
In the same complaint against the same Defendants,
the Company also alleged an infringement (requesting the same remedies) of ND Partners’ utility model DE 20 2005 022 124 U1 (the
−Removed: “Utility Model”), which the Company believes is fundamentally identical to the Prosl European Patent in its main aspects
+Added: “Utility Model”), which the Company believes is fundamentally identical to the Prosl European Patent in its main aspects and
The Court separated the two proceedings and the Prosl European Patent and the Utility Model claims were tried separately.
−Removed: TauroPharm has filed a cancellation action against the Utility Model before the German Patent and Trademark Office (the “German
−Removed: PTO”) based on the similar arguments as those in the opposition against the Prosl European Patent.
−Removed: CORMEDIX INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
+Added: has filed a cancellation action against the Utility Model before the German Patent and Trademark Office (the “German PTO”)
+Added: based on the similar arguments as those in the opposition against the Prosl European Patent.
The Court issued its decisions on May 8, 2015,
12 unchanged sentences
underlying validity of the Prosl European Patent and the Utility Model.
−Removed: The opposition proceeding against the Prosl European
−Removed: Patent before the EPO is ongoing.
−Removed: The EPO held a hearing in the opposition proceeding on November 25, 2015.
−Removed: However, the EPO did not
−Removed: issue a decision at the end of the hearing but adjourned the matter due to the fact that the panel was of the view that Claus Herdeis,
−Removed: one of the managing directors of TauroPharm, had to be heard as a witness in a further hearing in order to close some gaps in the documentation
−Removed: presented by TauroPharm as regards the publication of the prior art.
+Added: The EPO held a hearing in the opposition proceeding
+Added: on November 25, 2015.
+Added: However, the EPO did not issue a decision at the end of the hearing but adjourned the matter due to the fact that
+Added: the panel was of the view that Claus Herdeis, one of the managing directors of TauroPharm, had to be heard as a witness in a further hearing
+Added: in order to close some gaps in the documentation presented by TauroPharm as regards the publication of the prior art.
+Added: CORMEDIX INC.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
The German PTO held a hearing in the validity proceedings
16 unchanged sentences
with this decision and has appealed the decision.
−Removed: The Company continues to believe that the Prosl European Patent is indeed novel and
−Removed: that its validity should be maintained.
−Removed: There can be no assurance that the Company will prevail in this matter.
−Removed: On January 16, 2015, the Company filed a complaint against TauroPharm
−Removed: GmbH and its managing directors in the District Court of Cologne, Germany.
−Removed: In the complaint, the Company alleged violation
−Removed: of the German Unfair Competition Act by TauroPharm and that TauroPharm is improperly and unfairly using its proprietary information relating
−Removed: to the composition and manufacture of Neutrolin, in the manufacture and sale of TauroPharm’s products TauroLock TM , TauroLock-HEP100
−Removed: and TauroLock-HEP500.
−Removed: The Company sought a cease and desist order against TauroPharm from continuing to manufacture and sell any product
−Removed: containing taurolidine (the active pharmaceutical ingredient (“API”) of Neutrolin) and citric acid in addition to possible
−Removed: other components, damages for any sales in the past and the removal of all such products from the market.
−Removed: Hearings in this matter
−Removed: were held in the District Court of Cologne, Germany on November 19, 2015, on November 15, 2016 and on November 20, 2018.
−Removed: A decision was
−Removed: rendered by the court on December 11, 2018, dismissing the complaint in its entirety.
+Added: In a hearing on October 27, 2022 before the EPO Board of Appeals, the Board expressed
+Added: the view that the patent claims of the Prosl European Patent on file were not inventive over prior art presented by TauroPharm.
+Added: thus withdrew its appeal against the first instance decision.
+Added: This means that the invalidation of the patent has become final and that,
+Added: as a consequence, the infringement proceedings, which are formally still ongoing, will also be closed because there is no underlying patent
+Added: In view of the invalidation of the Prosl European Patent, on November 9, 2022, the Defendants requested the infringement
+Added: proceedings (docket number 7 O 118/14) to be resumed and to dismiss our infringement action.
+Added: In order to avoid a dismissal,
+Added: on January 12, 2023, the Company withdrew the infringement action with prejudice.
+Added: The Defendants consented to the withdrawal on February
+Added: 2, 2023 and requested that the Company, as plaintiff, bears the costs of the proceedings.
+Added: Given that pursuant to statutory law, a plaintiff
+Added: that withdraws an action, has to bear the costs of the proceedings, The Company put the decision on who has to bear the costs in the District
+Added: Court of Mannheim’s discretion.
+Added: Due to the withdrawal, there will be no decision on the merits, however, the District Court of Mannheim
+Added: will issue a decision that the Company has to bear the cost of the proceedings.
+Added: Given that the court fees have already been paid by the
+Added: Company, the cost of the proceedings are the costs that will have to be reimbursed to the Defendants, i.e mainly statutory attorney’s
+Added: fees and expenses.
+Added: On January 16, 2015, the Company filed a complaint
+Added: against TauroPharm GmbH and its managing directors in the District Court of Cologne, Germany.
+Added: In the complaint, the Company
+Added: alleged violation of the German Unfair Competition Act by TauroPharm and that TauroPharm is improperly and unfairly using its proprietary
+Added: information relating to the composition and manufacture of Neutrolin, in the manufacture and sale of TauroPharm’s products TauroLock TM ,
+Added: TauroLock-HEP100 and TauroLock-HEP500.
+Added: The Company sought a cease and desist order against TauroPharm from continuing to manufacture and
+Added: sell any product containing taurolidine (the active pharmaceutical ingredient (“API”) of Neutrolin) and citric acid in addition
+Added: to possible other components, damages for any sales in the past and the removal of all such products from the market.
+Added: this matter were held in the District Court of Cologne, Germany on November 19, 2015, on November 15, 2016 and on November 20, 2018.
+Added: decision was rendered by the court on December 11, 2018, dismissing the complaint in its entirety.
The Company therefore appealed in January
14 unchanged sentences
legal counsel of the Company.
−Removed: The Company will have to reimburse costs in the amount of approximately $ 41,000 plus interest to TauroPharm.
+Added: The Company reimbursed costs in the amount of approximately $ 41,000 plus interest to TauroPharm.
+Added: In connection with the aforementioned patent and
+Added: utility model infringement and unfair competition proceedings against TauroPharm, the Company was required by the District Courts of Mannheim
+Added: and Cologne to provide security deposits to cover legal fees in the event TauroPharm is entitled to reimbursement of these costs.
+Added: of December 31, 2022, the aggregate deposit was approximately $ 124,000 , which the Company recorded as restricted cash on the consolidated
+Added: balance sheets.
+Added: On February 8, 2023, the Regional Court of Cologne informed the Company that the security deposit in two proceedings
+Added: (81 HL 448/15 and 81 HL 903/19), in the amount of 36,000 EUR and 10,000 EUR, (approximately in aggregate of $ 49,000 ),
+Added: will be refunded to CorMedix and that it instructed their accounting department to wire transfer the two security deposits.
+Added: The remaining
+Added: aggregate deposit of about $ 75,000 remains in security deposit.
CORMEDIX INC.
1 unchanged sentence
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
−Removed: In connection with the aforementioned patent and
−Removed: utility model infringement and unfair competition proceedings against TauroPharm, the Company was required by the District Courts of
−Removed: Mannheim and Cologne to provide security deposits to cover legal fees in the event TauroPharm is entitled to reimbursement of these costs.
−Removed: of December 31, 2021, the aggregate deposit was approximately $ 132,000 , which the Company recorded as restricted cash on the condensed
−Removed: consolidated balance sheets, after deducting approximately $ 48,000 released by the court to the Company during the year ended December
In 2008, the Company entered into a License and
29 unchanged sentences
the Company’s rights to the NDP Technology will revert back to NDP.
−Removed: Employment Agreements
−Removed: On September 27, 2016, the Company entered
−Removed: into an employment agreement with Khoso Baluch, its former Chief Executive Officer, which upon its expiration in September 2019,
−Removed: was replaced with a new agreement, dated September 26, 2019.
−Removed: On October 4, 2021, Mr.
−Removed: Baluch retired from the Company and
−Removed: his employment agreement was terminated.
−Removed: In connection with his separation from service, the Company and Mr.
−Removed: Baluch entered into
−Removed: a separation agreement and release dated as of October 1, 2021 (the “Baluch Separation Agreement”).
−Removed: retirement was treated as a termination without Cause (as defined below) under the employment agreement.
−Removed: Under the Baluch Separation Agreement,
−Removed: Baluch received the severance payments and benefits described below with respect to a termination by the Company without Cause.
−Removed: Baluch met the eligibility requirements for retirement as of the date of his separation, so certain of Mr.
−Removed: vested stock options will be exercisable for up to three years after the date of his separation under the terms of the applicable
−Removed: grant agreements.
−Removed: The Baluch Separation Agreement provides this retirement treatment for all of Mr.
−Removed: Baluch’s outstanding vested
−Removed: The Company reimbursed Mr.
−Removed: Baluch for legal fees incurred in connection with the review of the Baluch Separation Agreement.
−Removed: Baluch is bound by confidentiality, non-solicitation and non-competition covenants under his employment agreement, and an extended
−Removed: covenant not to solicit employees under the Baluch Separation Agreement, among other terms.
−Removed: Total severance amount was $ 495,833 of which
−Removed: $ 177,492 was paid and $ 318,341 was accrued as of December 31, 2021.
−Removed: CORMEDIX INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
−Removed: On March 1, 2017, the Company entered into an employment agreement
−Removed: with John Armstrong, its former Executive Vice President for Technical Operations, which upon its expiration in March 2020,
−Removed: was replaced with a new agreement dated April 17, 2020.
−Removed: On October 4, 2021, Mr.
−Removed: Armstrong retired from the Company and
−Removed: his employment agreement was terminated.
−Removed: In connection with his separation from service, the Company and Mr.
−Removed: Armstrong entered into
−Removed: a separation agreement and release dated as of October 4, 2021 (the “Armstrong Separation Agreement”).
−Removed: retirement was treated as a termination without Cause under the employment agreement.
−Removed: Under the Armstrong Separation Agreement, Mr.
−Removed: received the severance payments and benefits described below with respect to a termination by the Company without Cause.
−Removed: met the eligibility requirements for retirement as of the date of his separation, so certain of Mr.
−Removed: Armstrong’s vested stock
−Removed: options will be exercisable for up to three years after the date of his separation under the terms of the applicable grant agreements.
−Removed: The Armstrong Separation Agreement provides this retirement treatment for all outstanding vested options.
−Removed: The Company reimbursed Mr.
−Removed: for legal fees incurred in connection with the review of the Armstrong Separation Agreement.
−Removed: Armstrong is bound by confidentiality,
−Removed: non-solicitation and non-competition covenants under his employment agreement, and an extended covenant not to solicit employees under
−Removed: the Armstrong Separation Agreement, among other terms.
−Removed: Total severance amount was $ 297,917 of which $ 134,514 was paid and $ 163,403 was
−Removed: accrued as of December 31, 2021.
−Removed: On March 19, 2018, the Company entered into
−Removed: an employment agreement with Elizabeth Masson-Hurlburt to serve as its Executive Vice President and Head of Clinical Operations,
−Removed: which upon its expiration in March 2021, was replaced with a new agreement dated March 10, 2021.
−Removed: On March 19, 2019, the
−Removed: Company entered into an employment agreement with Phoebe Mounts to serve as its Executive Vice President and General Counsel and Head
−Removed: of Regulatory, Compliance and Legal, effective May 1, 2019.
−Removed: On April 29, 2021, the Company entered into an employment agreement
−Removed: with Thomas Nusbickel to serve as its Executive Vice President and Chief Commercial Officer, effective May 13, 2021.
−Removed: the initial three-year term of each employment agreement, the term of the employment agreement will automatically renew for additional
−Removed: successive one-year periods, unless either party notifies the other in writing at least 90 days before the expiration of the then-current
−Removed: term that the term will not be renewed.
−Removed: On May 11, 2020, the Company entered into
−Removed: an employment agreement with Matthew David to serve as its Chief Financial Officer.
−Removed: After the initial three-year term of the employment
−Removed: agreement, the term of the employment agreement will automatically renew for additional successive one-year periods, unless either party
−Removed: notifies the other in writing at least 90 days before the expiration of the then-current term that the term will not be renewed.
−Removed: On October 26, 2021, the Company entered into a letter agreement with Dr.
−Removed: David which modified certain terms of his employment agreement
−Removed: and provided other compensation as a result of Dr.
−Removed: David serving as the Company’s interim Chief Executive Officer effective as
−Removed: of October 4, 2021.
−Removed: Pursuant to the letter agreement, during the period in which Dr.
−Removed: David serves as interim Chief Executive Officer,
−Removed: his base salary will increase to $ 425,000 from $ 330,000 , which is the amount set forth in his employment agreement and will be reviewed
−Removed: and increased, if appropriate, by the Company’s Compensation Committee six months following October 4, 2021 if Dr.
−Removed: David continues
−Removed: to serve as interim Chief Executive Officer on such date.
−Removed: David ceases to serve as interim Chief Executive Officer, and as
−Removed: he continues to serve as Chief Financial Officer, the Company will provide him with an annual base salary of $ 375,000 , representing a
−Removed: $ 45,000 increase from his current salary level under the employment agreement.
−Removed: The Board, or the Company’s Compensation Committee,
−Removed: will review such base salary to determine whether an increase is appropriate in 2022 as part of the 2022 compensation review cycle and
−Removed: benchmarking review.
−Removed: Under the letter agreement, Dr.
−Removed: David’s target annual bonus with respect to the period during which he serves
−Removed: as interim Chief Executive Officer is increased to 60 % from 30 % of his base salary, which is otherwise set forth in his employment agreement.
−Removed: David ceases to serve as interim Chief Executive Officer, and as he continues to serve as Chief Financial Officer, his target
−Removed: annual bonus will increase to 40 % of his base salary.
−Removed: Under the letter agreement, in the event Dr.
−Removed: David’s employment is terminated
−Removed: by the Company other than as a result of his death or disability or notice of nonrenewal of the employment agreement, and other than
−Removed: for Cause, or if he resigns for Good Reason, in either case during the period he serves as interim Chief Executive Officer, he will be
−Removed: eligible for severance equal to his base salary for a period of 12 months following his termination date, which is increased from nine
−Removed: months as is otherwise provided for in his employment agreement.
−Removed: David has agreed to waive any rights he may have under his employment
−Removed: agreement to a Good Reason termination as a result of his ceasing to serve as our interim Chief Executive Officer at a future date.
−Removed: connection with Dr.
−Removed: David serving as interim Chief Executive Officer, the Board granted Dr.
−Removed: David a stock option with respect to 125,000
−Removed: shares of the Company’s common stock with an exercise price of $ 5.56 per share, which was the closing price of the Company’s
−Removed: common stock on the Nasdaq Global Market on the date of grant.
−Removed: The option vests over four years in four equal annual installments beginning
−Removed: on the date of grant, subject to Dr.
−Removed: David’s continued employment, consistent with the terms of the Company’s standard form
−Removed: of option agreement.
−Removed: CORMEDIX INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
−Removed: Pursuant to their respective employment agreements,
−Removed: Baluch received an annual salary of $425,000, Mr.
−Removed: Armstrong received an annual salary of $325,000, Ms.
−Removed: Masson-Hurlburt
−Removed: receives an annual salary of $315,000 (effective March 2021), Dr.
−Removed: Mounts receives an annual salary of $350,000 (amended to
−Removed: $375,000 in January 2021), Mr.
−Removed: Nusbickel receives and annual salary of $375,000 and Dr.
−Removed: David receives an annual salary of
−Removed: $330,000 (amended to $425,000 while he serves as interim Chief Executive Officer).
−Removed: Such salaries cannot be decreased unless all officers
−Removed: and/or members of the Company’s executive management team experience an equal or greater percentage reduction in base salary and/or
−Removed: total compensation, provided that any reduction in an executive’s salary may be no greater than 25%.
−Removed: Each executive will be eligible
−Removed: for an annual bonus, which may equal up to 80% for Mr.
−Removed: Baluch (the target amount is 80%, but the bonus may exceed that amount),
−Removed: up to 35% for Mr.
−Removed: Armstrong, up to 30% for Ms.
−Removed: Masson-Hurlburt, up to 30% for Dr.
−Removed: Mounts, up to 30% for Mr.
−Removed: Nusbickel and up
−Removed: to 30% for Dr.
−Removed: David (and up to 60% while he serves as interim Chief Executive Officer), of his or her base salary then in effect,
−Removed: as determined by the Company’s Board or the Compensation Committee.
−Removed: In determining such bonus payment, the Company’s Board
−Removed: or the Compensation Committee will take into consideration the achievement of specified Company objectives, predetermined by the Company’s
−Removed: Board or the Compensation Committee and Chief Executive Officer, and such other factors as the Company’s Board or the Compensation
−Removed: Committee deems appropriate.
−Removed: Each executive must be employed through December 31 of a given year to be eligible to earn that year’s
−Removed: annual bonus.
−Removed: The following provisions of the employment
−Removed: agreements with Dr.
−Removed: Masson-Hurlburt and Mr.
−Removed: Nusbickel are identical except where noted.
−Removed: If the Company terminates the executive’s
−Removed: employment for Cause, the executive will be entitled to receive only the accrued compensation due to him or her as of the date
−Removed: of such termination, rights to indemnification and directors’ and officers’ liability insurance, and as otherwise required
−Removed: by law, and certain equity awards will be forfeited.
−Removed: If the Company terminates the executive’s
−Removed: employment other than for Cause, and other than for death, disability or notice of nonrenewal, or if the executive resigns for Good Reason
−Removed: (as defined below), the executive will receive the following benefits:
−Removed: (i) payment of any accrued compensation and any unpaid bonus
−Removed: relating to the completed prior year, as well as rights to indemnification and directors’ and officers’ liability insurance
−Removed: and any rights or privilege otherwise required by law;
−Removed: (ii) the Company will continue to pay his or her base salary for a period
−Removed: of twelve months in the case of Mr.
−Removed: Baluch and Dr.
−Removed: David while he is serving as interim Chief Executive Officer, and nine months
−Removed: for the other executives following the effective date of the termination of employment;
−Removed: (iii) payment on a prorated basis for any
−Removed: target bonus for the year of termination based on the actual achievement of the specified bonus objectives;
−Removed: (iv) if the executive
−Removed: timely elects continued health insurance coverage under COBRA, then the Company will pay the premium to continue such coverage for him
−Removed: or her and his or her eligible dependents in an amount equal to the portion paid for by the Company during the executive’s employment until
−Removed: the conclusion of the time when he or she is receiving continuation of base salary payments or until he or she becomes eligible for group
−Removed: health insurance coverage under another employer’s plan, whichever occurs first, provided however that the Company has the right
−Removed: to terminate such payment of COBRA premiums on behalf of the executive and instead pay him or her a lump sum amount equal to the COBRA
−Removed: premium times the number of months remaining in the specified period if the Company determines in its discretion that continued
−Removed: payment of the COBRA premiums is or may be discriminatory under Section 105(h) of the Code;
−Removed: and (v) unvested equity awards
−Removed: that are scheduled to vest on or before the next succeeding anniversary of the date of termination shall be accelerated and deemed to
−Removed: have vested as of the termination date;
−Removed: provided that any performance based equity awards or stock options whose vesting requirements
−Removed: have not been successfully met as of the date of termination of employment or resignation with Good Reason will not accelerate.
−Removed: the event of a termination by the Company without Cause or the executive’s resignation of employment for Good Reason, in either
−Removed: case within 24 months following a Corporate Transaction (as defined in the employment agreement), all equity awards and stock options
−Removed: shall become fully vested and exercisable, and vested stock options will remain exercisable for a specified period of time following
−Removed: termination or resignation or, if earlier, the expiration date of the stock option.
−Removed: The separation benefits set forth above are conditioned
−Removed: upon the executive executing a release of claims against us, our parents, subsidiaries, and affiliates, and each such entities’
−Removed: officers, directors, employees, agents, successors, and assigns in a form acceptable to us, within a time specified therein, which release
−Removed: is not revoked within any time period allowed for revocation under applicable law.
−Removed: CORMEDIX INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
−Removed: For purposes of the agreement, “Cause”
−Removed: is defined as:
−Removed: (i) the willful failure, disregard, or refusal by the executive to perform his or her material duties or obligations
−Removed: under the employment agreement (other than as a result of executive’s mental incapacity or illness;
−Removed: (ii) any willful, intentional,
−Removed: or grossly negligent act by the executive having the effect of materially injuring (whether financially or otherwise) our business or
−Removed: reputation or any of our affiliates;
−Removed: (iii) executive’s conviction of any felony involving moral turpitude (including entry
−Removed: of a guilty or nolo contendere plea);
−Removed: (iv) the executive’s qualification as a “bad actor,” as defined by 17 CFR
−Removed: (v) the good faith determination by the Board, after a reasonable and good-faith investigation by the Company that the
−Removed: executive engaged in some form of harassment or discrimination prohibited by law (including, without limitation, harassment on the basis
−Removed: of age, sex or race) unless the executive’s actions were specifically directed by the Board;
−Removed: (vi) any material misappropriation
−Removed: or embezzlement by the executive of the Company or its affiliates’ property (whether or not a misdemeanor or felony);
−Removed: or (vii) material
−Removed: breach by the executive of the employment agreement that is materially injurious to the Company and that is not cured, to the extent
−Removed: subject to cure, by executive to our reasonable satisfaction.
−Removed: For purposes of the agreement, “Good Reason”
−Removed: is defined as any of the following without the executive’s consent:
−Removed: (i) any material breach of the employment agreement by
−Removed: (ii) any material diminution by the Company of the executive’s duties, responsibilities, or authority;
−Removed: material reduction in the executive’s annual base salary unless all officers and/or members of the Company’s executive
−Removed: management team experience an equal or greater percentage reduction in annual base salary and/or total compensation, provided that
−Removed: any reduction may be no greater than 25%;
−Removed: (iv) a material reduction in the executive’s target bonus level unless all officers
−Removed: and/or members of our executive management team experience an equal or greater percentage reduction related to target bonus levels, provided
−Removed: that any reduction may be no greater than 25%.
−Removed: If the executive terminates his or her
−Removed: employment by written notice of termination or if the executive or the Company terminates his or her employment by providing a notice
−Removed: of nonrenewal at least 90 days before the employment agreement is set to expire, the executive will not be entitled to receive any
−Removed: payments or benefits other than any accrued compensation, any unpaid prior year’s bonus, rights to indemnification and directors’
−Removed: and officers’ liability insurance and as otherwise required by law.
−Removed: If the executive’s employment is terminated
−Removed: as a result of his or her death or disability, the Company will pay him or her or his or her estate, as applicable, any accrued compensation
−Removed: and any unpaid prior year’s bonus.
−Removed: The Company’s employment agreements with
−Removed: Masson-Hurlburt and Mr.
−Removed: Nusbickel each contain a non-compete provision that provides that during the employment
−Removed: and for a specified period immediately following the executive’s separation from employment for any reason, the executive is prohibited
−Removed: from engaging in any business involving the development or commercialization of a preventive anti-infective product that would be a direct
−Removed: competitor of Defencath/Neutrolin or a product containing taurolidine or any other product being actively developed or produced by the
−Removed: Company within the United States and the European Union (or in the case of Dr.
−Removed: Masson-Hurlburt and Mr.
−Removed: worldwide) on the date of termination of his or her employment.
−Removed: The Company entered into a seven-year operating
−Removed: lease agreement in March 2020 for an office space at 300 Connell Drive, Berkeley Heights, New Jersey 07922.
−Removed: The lease agreement, with
−Removed: a monthly average of approximately $ 17,000 commenced on September 16, 2020.
−Removed: The Company’s sublease on its previous premises at
−Removed: 400 Connell Drive, Berkeley Heights, New Jersey 07922 terminated on November 30, 2020 (see Note 10).
Note 9 — Stockholders’ Equity:
Common Stock:
−Removed: On July 30, 2020, the Company completed an underwritten
−Removed: public offering of its common stock, par value $ 0.001 per share, which yielded net proceeds of approximately $ 21.3 million.
−Removed: The public offering was made pursuant to an underwriting agreement with SunTrust Robinson Humphrey, Inc.
−Removed: and JMP Securities LLC (collectively,
−Removed: the “Underwriters”), relating to the issuance and sale of an aggregate of 5,111,110 shares of common stock, including 666,666 shares
−Removed: of common stock pursuant to the full exercise of the Underwriters’ option to purchase additional shares, at a public offering price
−Removed: of $ 4.50 per share.
−Removed: The offering was made pursuant to the Company’s effective registration statement on Form S-3 Registration
−Removed: Statement No.
−Removed: 333-223562 previously filed with and declared effective by the SEC and a prospectus supplement and accompanying prospectus
−Removed: filed with the SEC.
+Added: In November 2020, the Company filed a shelf registration
+Added: statement, (the “2020 Shelf Registration”), under which the Company could issue and sell up to an aggregate of $100,000,000
+Added: of shares of its common stock, $0.001 par value per share.
+Added: On November 27, 2020, the Company entered into an Amended and Restated At Market
+Added: Issuance Sales Agreement (the “Amended Sales Agreement”) with FBR Securities, Inc.
+Added: (formerly known as B.
+Added: Riley FBR Inc.) and
+Added: Needham & Company, LLC as sales agents.
+Added: The Amended Sales Agreement relates to the sale of shares of up to $50,000,000 of its common
+Added: stock under its at-the-market program (the “ATM program”), of which the Company may issue and sell common stock from time
+Added: to time through the sales agents, subject to limitations imposed by the Company and subject to the sales agents’ acceptance, such
+Added: as the number or dollar amount of shares registered under the 2020 Shelf Registration to which the offering relates.
+Added: Sales agents are
+Added: entitled to a commission of up to 3% of the gross proceeds from the sale of common stock sold under the ATM program.
+Added: During the year ended
+Added: December 31, 2021, the ATM program under the Amended Sales Agreement had been fully sold.
+Added: On August 12, 2021, the Company entered into a
+Added: new At Market Issuance Sales Agreement with Truist Securities, Inc.
+Added: and JMP Securities LLC, as sales agents, pursuant to which the Company
+Added: may sell, from time to time, an aggregate of up to $ 50,000,000 of its common stock through the sales agents under its ATM program, subject
+Added: to limitations imposed by the Company and subject to the sales agents’ acceptance, such as the number or dollar amount of shares
+Added: registered under the 2020 Shelf Registration to which the offering relates.
+Added: The sales agents are entitled to a commission of up to 3 %
+Added: of the gross proceeds from the sale of common stock sold under the ATM program.
+Added: As of December 31, 2022, the Company has $ 31,600,000 available
+Added: under its ATM program relating to its 2020 Shelf Registration filed in November 2020.
CORMEDIX INC.
1 unchanged sentence
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
−Removed: The Company had a prior sales agreement with FBR
−Removed: Securities, Inc., (formerly known as B.
−Removed: Riley FBR, Inc.) (“B.
−Removed: Riley”) for its ATM program, which expired on April 16, 2018,
−Removed: under which the Company could issue and sell up to an aggregate of $60.0 million of shares of its common stock.
−Removed: On March 9, 2018, the
−Removed: Company entered into a new agreement with B.
−Removed: Riley for the sale of up to $14.7 million of the Company’s common stock under the ATM
−Removed: program, pursuant to a registration statement filed on March 9, 2018 for an aggregate of $70 million of the Company’s securities,
−Removed: which became effective on April 16, 2018.
−Removed: This new ATM agreement replaced a prior sales agreement with B.
−Removed: Riley that expired on April
−Removed: The ATM program amount was increased by $25.0 million in November 2018.
−Removed: Under the ATM program, the Company may issue and sell
−Removed: common stock from time to time through B.
−Removed: Riley acting as agent, subject to limitations imposed by the Company and subject to B.
−Removed: acceptance, such as the number or dollar amount of shares registered under the registration statement to which the offering relates.
−Removed: Riley is entitled to a commission of up to 3% of the gross proceeds from the sale of common stock sold under the ATM program.
−Removed: year ended December 31, 2020, the Company sold 1,854,970 shares of common stock under the new and expired ATM programs, and realized net
−Removed: proceeds of approximately $11.4 million.
−Removed: At December 31, 2020, this ATM program and the current shelf registration for the issuance of
−Removed: equity, debt or equity-linked securities has been exhausted.
−Removed: In November 2020, the Company filed a new registration
−Removed: statement, under which the Company could issue and sell up to an aggregate of $100.0 million of shares of its common stock.
−Removed: 27, 2020, the Company entered into an Amended and Restated At Market Issuance Sales Agreement (“Amended Sales Agreement”)
−Removed: Riley FBR Inc.
−Removed: and Needham & Company, LLC as sales agents.
−Removed: The Amended Sales Agreement relates to the sale of shares of up
−Removed: to $25.0 million of the Company’s common stock under its ATM program, of which the Company may issue and sell common stock from
−Removed: time to time through the sales agents, subject to limitations imposed by the Company and subject to the sales agents’ acceptance,
−Removed: such as the number or dollar amount of shares registered under the registration statement to which the offering relates.
−Removed: The sales agents
−Removed: are entitled to a commission of up to 3% of the gross proceeds from the sale of common stock sold under the ATM program.
−Removed: During the year
−Removed: ended December 31, 2020, the Company sold 832,676 shares of common stock under the Amended Sales Agreement and realized net proceeds of
−Removed: approximately $ 7.0 million.
−Removed: At December 31, 2020, the Company had approximately $17.8 million available under the Amended Sales Agreement
−Removed: and $75.0 million available under its shelf registration statement for the issuance of equity, debt or equity-linked securities unrelated
−Removed: to the Amended Sales Agreement.
−Removed: On February 5, 2021, the Company allocated to its ATM program an additional $25.0 million of the remaining
−Removed: $75.0 million available under its shelf registration statement.
−Removed: Giving effect to the additional $25.0 million, plus the $17.8 million
−Removed: available at December 31, 2020, the Company had a total of $42.8 million available under the ATM program at February 5, 2021.
−Removed: year ended December 31, 2021, the Company sold an aggregate of 3,737,862 shares of its common stock under the ATM program and realized
−Removed: net proceeds of approximately $41.5 million.
−Removed: On August 12, 2021, the Company entered into an
−Removed: At Market Issuance Sales Agreement with Truist Securities, Inc.
−Removed: and JMP Securities LLC, as sales agents, pursuant to which the Company
−Removed: may sell, from time to time, an aggregate of up to $50.0 million of its common stock through the sales agents under its ATM program, subject
−Removed: to limitations imposed by the Company and subject to the sales agent’s acceptance, such as the number or dollar amount of shares
−Removed: registered under the registration statement to which the offering relates.
−Removed: The sales agents are entitled to a commission of up to 3% of
−Removed: the gross proceeds from the sale of common stock sold under the ATM program.
−Removed: As of December 31, 2021, the Company has $ 50.0 million available
−Removed: under its ATM program relating to its shelf registration statement filed in November 2020 and it has $ 150.0 million available under its
−Removed: new shelf registration statement filed on August 12, 2021 for the issuance of equity, debt or equity-linked securities.
−Removed: During the year ended December 31, 2021, the Company
−Removed: issued an aggregate of 656,069 shares of its common stock upon conversion of 50,000 Series C-3 preferred shares by an unrelated party
−Removed: and 10,001 Series G preferred shares by a related party.
+Added: Also, on August 12, 2021, the Company filed a new
+Added: shelf registration statement (the “2021 Shelf Registration”) for the issuance of up to $ 150,000,000 of shares of its common
+Added: stock which is currently available for the issuance of equity, debt or equity-linked securities.
During the year ended December 31, 2022 and 2021,
+Added: the Company sold an aggregate of 4,704,259 and 3,737,862 shares of its common stock under the ATM program, respectively, and realized
+Added: net proceeds of $ 17,770,000 and $ 41,456,000 , respectively.
+Added: During the year ended December 31, 2022 and 2021,
the Company issued an aggregate of 24,500 and 31,407 shares of its common stock, respectively, upon cash exercise of warrants, resulting
1 unchanged sentence
During the year ended December 31, 2021, the Company
+Added: issued an aggregate of 656,069 shares of its common stock upon conversion of 50,000 Series C-3 preferred shares by an unrelated party
+Added: and 10,001 Series G preferred shares by a related party.
+Added: During the year ended December 31, 2021, the Company
issued an aggregate of 70,269 shares of its common stock upon cashless exercise of 95,286 warrants.
−Removed: CORMEDIX INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
−Removed: During the year ended December 31, 2021, there
−Removed: were no restricted stock units issued by the Company and for the year ended December 31, 2020, the Company issued an aggregate of 2,490
−Removed: shares of its common stock upon the vesting of restricted stock units issued to the Company’s board of directors.
During the year ended December 31, 2021, the Company
issued an aggregate of 32,734 shares of its common stock upon exercise of stock options, resulting in net proceeds to the Company of $ 137,000 .
−Removed: No stock options were exercised during the year ended December 31, 2020.
Restricted Stock Units
−Removed: During the years ended December 31, 2021 and 2020
−Removed: the Company did not grant any restricted stock units (“RSUs”) to its officers and directors.
−Removed: During the year ended December
−Removed: 31, 2020, the compensation expense recorded for the 2,490 RSUs that vested was $ 11,000 .
−Removed: At December 31, 2021 and 2020, there were no RSUs
+Added: On May 10, 2022, the Company granted 207,469 restricted
+Added: stock units (“RSUs”) to its chief executive officer under its Amended and Restated 2019 Omnibus Stock Incentive Plan with
+Added: a weighted average grant date fair value of $ 3.38 per share.
+Added: The fair market value of the RSUs was estimated to be the closing price of
+Added: the Company’s common stock on the date of grant.
+Added: These RSUs vest as to 50 % on the first anniversary of the grant date, as to 30 %
+Added: on the second anniversary of the grant date, and as to 20 % on the third anniversary of the grant date, subject to continued service as
+Added: an employee or consultant through the applicable vesting date.
+Added: During the year ended December 31, 2022, compensation
+Added: expense recorded for the RSUs was $ 226,000 .
+Added: Unrecognized compensation expense for these RSUs amounted to $ 475,000 .
+Added: The expected weighted
+Added: average period for the expense to be recognized is 1.4 years.
+Added: CORMEDIX INC.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
Preferred Stock
6 unchanged sentences
Company’s board of directors has designated (all with par value of $ 0.001 per share) the following:
−Removed: As of December 31, 2021
−Removed: As of December 31, 2020
+Added: As of December 31, 2022 and 2021
+Added: Preferred Shares
+Added: Liquidation Preference
+Added: Total Liquidation
During the year ended December 31, 2021, 50,000
6 unchanged sentences
stock will rank senior to our common stock;
−Removed: senior to any class or series of capital stock created after the issuance of
−Removed: the Series C-3 non-voting preferred stock;
−Removed: and junior to the Series E voting convertible preferred stock in each case, as to dividends
−Removed: or distributions of assets upon our liquidation, dissolution or winding up whether voluntarily or involuntarily.
+Added: senior to any class or series of capital stock created after the issuance of the
+Added: Series C-3 non-voting preferred stock;
+Added: and junior to the Series E voting convertible preferred stock in each case, as to dividends or
+Added: distributions of assets upon our liquidation, dissolution or winding up whether voluntarily or involuntarily.
Each share of Series C-3 preferred
stock is convertible into 2 shares of our common stock (subject to adjustment in the event of stock dividends and distributions, stock
−Removed: splits, stock combinations, or reclassifications affecting our common stock) at a per share price of $ 5.00 at any time at the option
−Removed: of the holder, except that a holder will be prohibited from converting shares of Series C-3 preferred stock into shares of common stock
−Removed: if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than 9.99 % of the total number
+Added: splits, stock combinations, or reclassifications affecting our common stock) at a per share price of $ 5.00 at any time at the option of
+Added: the holder, except that a holder will be prohibited from converting shares of Series C-3 preferred stock into shares of common stock if,
+Added: as a result of such conversion, such holder, together with its affiliates, would beneficially own more than 9.99 % of the total number
of shares of our common stock then issued and outstanding.
6 unchanged sentences
terms senior to the Series C-3 preferred stock and holders of Series C-3 preferred stock will participate ratably in the distribution
−Removed: of any remaining assets with the common stock and any other class or series of our capital stock hereafter created that participates
−Removed: with the common stock in such distributions.
+Added: of any remaining assets with the common stock and any other class or series of our capital stock hereafter created that participates with
+Added: the common stock in such distributions.
CORMEDIX INC.
7 unchanged sentences
Holders of Series C-3
−Removed: preferred stock are entitled to receive, and we are required to pay, dividends on shares of the Series C-3 preferred stock equal (on
−Removed: an as-if-converted-to-common-stock basis) to and in the same form as dividends (other than dividends in the form of common stock) actually
+Added: preferred stock are entitled to receive, and we are required to pay, dividends on shares of the Series C-3 preferred stock equal (on an
+Added: as-if-converted-to-common-stock basis) to and in the same form as dividends (other than dividends in the form of common stock) actually
paid on shares of the common stock when, as and if such dividends (other than dividends in the form of common stock) are paid on shares
2 unchanged sentences
to redeem or repurchase any shares of Series C-3 preferred stock.
−Removed: Shares of Series C-3 preferred stock are not otherwise entitled to
−Removed: any redemption rights, or mandatory sinking fund or analogous fund provisions.
+Added: Shares of Series C-3 preferred stock are not otherwise entitled to any
+Added: redemption rights, or mandatory sinking fund or analogous fund provisions.
There is no established
public trading market for the Series C-3 preferred stock, and we do not expect a market to develop.
−Removed: In addition, we do not intend to
−Removed: apply for listing of the Series C-3 preferred stock on any national securities exchange or trading system.
+Added: In addition, we do not intend to apply
+Added: for listing of the Series C-3 preferred stock on any national securities exchange or trading system.
Fundamental Transactions .
10 unchanged sentences
senior to the Series C-3 non-voting convertible preferred stock;
−Removed: and on parity with the Series G voting
−Removed: convertible preferred stock in each case, as to dividends or distributions of assets upon our liquidation, dissolution or winding up
−Removed: whether voluntarily or involuntarily.
+Added: and on parity with the Series G voting convertible
+Added: preferred stock in each case, as to dividends or distributions of assets upon our liquidation, dissolution or winding up whether voluntarily
+Added: or involuntarily.
Each share of Series E preferred
6 unchanged sentences
our liquidation, dissolution or winding up, holders of Series E preferred stock will receive a payment equal to $ 49.20 per share of Series
−Removed: E preferred stock on parity with the payment of the liquidation preference due the Series G preferred stock, but before any proceeds
−Removed: are distributed to the holders of common stock, and the Series C-3 non-voting convertible preferred stock.
−Removed: After the payment of this
−Removed: preferential amount, holders of Series E preferred stock will participate ratably in the distribution of any remaining assets with the
−Removed: common stock and any other class or series of our capital stock that participates with the common stock in such distributions.
+Added: E preferred stock on parity with the payment of the liquidation preference due the Series G preferred stock, but before any proceeds are
+Added: distributed to the holders of common stock, and the Series C-3 non-voting convertible preferred stock.
+Added: After the payment of this preferential
+Added: amount, holders of Series E preferred stock will participate ratably in the distribution of any remaining assets with the common stock
+Added: and any other class or series of our capital stock that participates with the common stock in such distributions.
+Added: CORMEDIX INC.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
Voting Rights.
3 unchanged sentences
stock are entitled to receive, and we are required to pay, dividends on shares of the Series E preferred stock equal (on an as-if-converted-to-common-stock
−Removed: basis) to and in the same form as dividends (other than dividends in the form of common stock) actually paid on shares of the common
−Removed: stock when, as and if such dividends (other than dividends in the form of common stock) are paid on shares of the common stock.
+Added: basis) to and in the same form as dividends (other than dividends in the form of common stock) actually paid on shares of the common stock
+Added: when, as and if such dividends (other than dividends in the form of common stock) are paid on shares of the common stock.
We are not obligated to redeem
6 unchanged sentences
listing of the Series E preferred stock on any national securities exchange or trading system.
−Removed: CORMEDIX INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
Fundamental Transactions.
9 unchanged sentences
trade payables incurred in the ordinary course of business consistent with past practice, and (ii) up to $ 10 million aggregate principal
−Removed: amount of indebtedness with a maturity less than twelve months outstanding at any time, which amount may include up to $5 million of
−Removed: letters of credit outstanding at any time.
+Added: amount of indebtedness with a maturity less than twelve months outstanding at any time, which amount may include up to $ 5 million of letters
+Added: of credit outstanding at any time.
Other Covenants.
3 unchanged sentences
or suffer to exist any encumbrances on any of our assets or property;
−Removed: redeem, repurchase or pay any cash dividend or distribution on
−Removed: any of our capital stock (other than as permitted, which includes the dividends on the Series E preferred stock and Series G preferred
+Added: redeem, repurchase or pay any cash dividend or distribution on any
+Added: of our capital stock (other than as permitted, which includes the dividends on the Series E preferred stock and Series G preferred stock);
redeem, repurchase or prepay any indebtedness (other than as permitted);
−Removed: or engage in any material line of business substantially
−Removed: different from our current lines of business.
+Added: or engage in any material line of business substantially different
+Added: from our current lines of business.
Purchase Rights.
−Removed: In the event we issue
−Removed: any options, convertible securities or rights to purchase stock or other securities pro rata to the holders of common stock, then a holder
−Removed: of Series E preferred stock will be entitled to acquire, upon the same terms a pro rata amount of such stock or securities as if the
−Removed: Series E preferred stock had been converted to common stock.
+Added: In the event we issue any
+Added: options, convertible securities or rights to purchase stock or other securities pro rata to the holders of common stock, then a holder
+Added: of Series E preferred stock will be entitled to acquire, upon the same terms a pro rata amount of such stock or securities as if the Series
+Added: E preferred stock had been converted to common stock.
Series G Voting Convertible Preferred Stock
7 unchanged sentences
or distributions of assets upon our liquidation, dissolution or winding up whether voluntarily or involuntarily.
+Added: CORMEDIX INC.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
Each share of Series G preferred
5 unchanged sentences
In the event of
−Removed: our liquidation, dissolution or winding up, holders of Series E preferred stock will receive a payment equal to $ 187.36452 per share
−Removed: of Series G preferred stock on parity with the payment of the liquidation preference due the Series E preferred stock, but before any
−Removed: proceeds are distributed to the holders of Series C-3 preferred stock (pending the consent of the holders of such series to the subordination
−Removed: thereof) and any proceeds are distributed to the holders of common stock.
−Removed: After the payment of this preferential amount, holders of Series
−Removed: G preferred stock will participate ratably in the distribution of any remaining assets with the common stock and any other class or series
−Removed: of our capital stock that participates with the common stock in such distributions.
+Added: our liquidation, dissolution or winding up, holders of Series E preferred stock will receive a payment equal to $ 187.36452 per share of
+Added: Series G preferred stock on parity with the payment of the liquidation preference due the Series E preferred stock, but before any proceeds
+Added: are distributed to the holders of Series C-3 preferred stock (pending the consent of the holders of such series to the subordination thereof)
+Added: and any proceeds are distributed to the holders of common stock.
+Added: After the payment of this preferential amount, holders of Series G preferred
+Added: stock will participate ratably in the distribution of any remaining assets with the common stock and any other class or series of our
+Added: capital stock that participates with the common stock in such distributions.
Voting Rights .
3 unchanged sentences
stock are entitled to receive, and we are required to pay, dividends on shares of the Series G preferred stock equal (on an as-if-converted-to-common-stock
−Removed: basis) to and in the same form as dividends (other than dividends in the form of common stock) actually paid on shares of the common
−Removed: stock when, as and if such dividends (other than dividends in the form of common stock) are paid on shares of the common stock.
+Added: basis) to and in the same form as dividends (other than dividends in the form of common stock) actually paid on shares of the common stock
+Added: when, as and if such dividends (other than dividends in the form of common stock) are paid on shares of the common stock.
We are not obligated to redeem
2 unchanged sentences
rights, or mandatory sinking fund or analogous fund provisions.
−Removed: CORMEDIX INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
There is no established public
13 unchanged sentences
trade payables incurred in the ordinary course of business consistent with past practice, and (ii) up to $ 10 million aggregate principal
−Removed: amount of indebtedness with a maturity less than twelve months outstanding at any time, which amount may include up to $5 million of
−Removed: letters of credit outstanding at any time.
+Added: amount of indebtedness with a maturity less than twelve months outstanding at any time, which amount may include up to $ 5 million of letters
+Added: of credit outstanding at any time.
+Added: CORMEDIX INC.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
Other Covenants .
3 unchanged sentences
or suffer to exist any encumbrances on any of our assets or property;
−Removed: redeem, repurchase or pay any cash dividend or distribution on
−Removed: any of our capital stock (other than as permitted, which includes the dividends on the Series E preferred stock and the Series G preferred
+Added: redeem, repurchase or pay any cash dividend or distribution on any
+Added: of our capital stock (other than as permitted, which includes the dividends on the Series E preferred stock and the Series G preferred
redeem, repurchase or prepay any indebtedness (other than as permitted);
2 unchanged sentences
Purchase Rights .
−Removed: In the event we issue
−Removed: any options, convertible securities or rights to purchase stock or other securities pro rata to the holders of common stock, then a holder
−Removed: of Series G preferred stock will be entitled to acquire, upon the same terms a pro rata amount of such stock or securities as if the
−Removed: Series G preferred stock had been converted to common stock.
+Added: In the event we issue any
+Added: options, convertible securities or rights to purchase stock or other securities pro rata to the holders of common stock, then a holder
+Added: of Series G preferred stock will be entitled to acquire, upon the same terms a pro rata amount of such stock or securities as if the Series
+Added: G preferred stock had been converted to common stock.
Stock Options:
−Removed: On November 26, 2019, the Company’s shareholders
−Removed: approved the CorMedix Inc.
−Removed: 2019 Omnibus Stock Incentive Plan (the “2019 Plan”).
−Removed: Pursuant to the 2019 Plan and subject to
−Removed: certain adjustments as described below, the Company may issue up to 3,000,000 shares of its common stock, plus any shares that remain
−Removed: available for grant under its 2013 Stock Incentive Plan (the “2013 Plan”) as of the effective date (up to a maximum carry-forward
−Removed: of 522,606 shares plus any outstanding options under the 2013 Plan that were canceled, forfeited and expired after the approval of the
−Removed: 2019 Plan), as long-term equity incentives to the Company’s employees, consultants, and directors.
−Removed: The long-term incentives may
−Removed: be in the form of stock options, stock appreciation rights, restricted stock, restricted stock units, dividend equivalent rights, or
−Removed: other rights or benefits (collectively, stock rights) to employees, consultants, and directors of the Company or a related entity (collectively,
−Removed: participants).
−Removed: The Company believes that the effective use of long- term equity incentives is essential to attract, motivate, and retain
−Removed: employees, consultants and directors, to further align participants’ interests with those of the Company’s stockholders,
−Removed: and to provide participants incentive compensation opportunities that are competitive with those offered by other companies in the same
−Removed: industry and locations as the Company.
−Removed: The 2019 Plan is a new equity compensation plan
−Removed: for the Company’s employees, consultants, and directors which replaced the 2013 Plan.
−Removed: The 2013 Plan and the Amended and Restated
−Removed: 2006 Stock Incentive Plan are referred to collectively as the “Prior Plans”.
+Added: On October 13, 2022, the Company’s shareholders approved the
+Added: CorMedix Inc.
+Added: Amended and Restated 2019 Omnibus Stock Incentive Plan (the “A&R 2019 Plan”), pursuant to which the Company
+Added: may issue an additional 4,800,000 shares of its common stock, plus any shares that remain available for grant under its existing plan
+Added: as of the effective date, as long-term equity incentives to the Company’s employees, consultants, and directors.
+Added: The long-term incentives
+Added: may be in the form of stock options, stock appreciation rights, restricted stock, restricted stock units, dividend equivalent rights,
+Added: or other rights or benefits (collectively, “stock rights”) to employees, consultants, and directors of the Company or a related
+Added: entity (collectively, “participants”).
+Added: The Company believes that the effective use of long- term equity incentives is essential
+Added: to attract, motivate, and retain employees, consultants and directors, to further align participants’ interests with those of the
+Added: Company’s stockholders, and to provide participants incentive compensation opportunities that are competitive with those offered
+Added: by other companies in the same industry and locations as the Company.
+Added: The A&R 2019 Plan is a new equity compensation plan for the Company’s
+Added: employees, consultants, and directors which replaced the 2019 Omnibus Stock Incentive Plan.
+Added: The 2013 Stock Incentive Plan and the 2019
+Added: Omnibus Stock Incentive Plan are referred to collectively as the “Prior Plans”.
No further awards will be granted under the
−Removed: Prior Plans after the approval of the 2019 Plan.
−Removed: Awards outstanding under the Prior Plans will remain outstanding in accordance with
−Removed: their terms and the Prior Plans.
+Added: Prior Plans after the approval of the A&R 2019 Plan.
+Added: Awards outstanding under the Prior Plans will remain outstanding in accordance
+Added: with their terms and the Prior Plans.
During the years ended December 31, 2022 and 2021,
3 unchanged sentences
exercise price of these options is $ 3.83 and $ 7.98 per share, respectively.
−Removed: CORMEDIX INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
During the years ended December 31, 2022 and 2021,
−Removed: total compensation expense for stock options issued to employees, directors, officers and consultants was $ 5,043,000 and $ 2,489,000 ,
−Removed: respectively.
−Removed: As of December 31, 2021, there was $ 5,516,000 total unrecognized compensation expense related to unvested stock options
−Removed: granted which expense is expected to be recognized over an expected remaining weighted average period of 1.6 years.
−Removed: All share-based awards
−Removed: are recognized on a straight-line method, assuming all awards granted will vest.
−Removed: Forfeitures of share-based awards are recognized in
−Removed: the period in which they occur.
−Removed: The fair value at grants dates of the grants issued
+Added: total compensation expense for stock options issued to employees, directors, officers and consultants was $ 3,843,000 and $ 5,043,000 , respectively.
+Added: As of December 31, 2022, there was $ 4,985,000 total unrecognized compensation expense related to unvested stock options granted which
+Added: expense is expected to be recognized over an expected remaining weighted average period of 1.5 years.
+Added: All share-based awards are recognized
+Added: on a straight-line method, assuming all awards granted will vest.
+Added: Forfeitures of share-based awards are recognized in the period in which
+Added: The fair value at grant dates of the grants issued
subject to service and performance-based vesting conditions were determined using the Black-Scholes option pricing model with the following
8 unchanged sentences
2.75 – 5 years
+Added: 1.97 - 5 years
Expected dividend yield
Weighted-average grant date fair value of options granted during the period
+Added: CORMEDIX INC.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
The Company estimated the expected term of the
11 unchanged sentences
the Company’s stock options activity and related information for the year ended December 31, 2022:
+Added: Shares Underlying Stock Options
+Added: Remaining Contractual Term (Years)
+Added: Aggregate Intrinsic Value
Outstanding at December 31, 2021
4 unchanged sentences
The aggregate intrinsic value is calculated as
−Removed: the difference between the exercise prices of the underlying options and the quoted closing price of the common stock of the Company
−Removed: at the end of the reporting period for those options that have an exercise price below the quoted closing price.
+Added: the difference between the exercise prices of the underlying options and the quoted closing price of the common stock of the Company at
+Added: the end of the reporting period for those options that have an exercise price below the quoted closing price.
During the years ended December 31, 2022 and 2021,
1 unchanged sentence
in net proceeds to the Company of $ 129,000 and $ 165,000 , respectively.
−Removed: CORMEDIX INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
During the year ended December 31, 2021, the Company
issued an aggregate of 70,269 shares of its common stock upon cashless exercise of 95,286 warrants.
−Removed: The following table is the summary of warrant
+Added: The following table is the summary of warrant activities:
+Added: Shares Underlying Warrants
+Added: Weighted Average Remaining Contractual Life
Outstanding at December 31, 2021
Outstanding at December 31, 2022
+Added: CORMEDIX INC.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
Stock-based Deferred Compensation Plan for Non-Employee Directors
10 unchanged sentences
The Company accounts for this plan as stock-based compensation under ASC 718.
−Removed: During the year ended December 31,
−Removed: 2021, no compensation was deferred under this plan and during the year ended December 31, 2020, the amount of compensation that was deferred
−Removed: under this plan was $ 62,250 .
+Added: During the years ended December 31,
+Added: 2022 and 2021 no compensation was deferred under this plan.
Note 10 — Concentrations:
−Removed: At December 31, 2021 and 2020, one customer exceeded
−Removed: 10 % of the Company’s accounts receivable ( 100 % and 95 %).
−Removed: During the year ended December 31, 2021, the Company had revenue from
−Removed: three customers that exceeded 10 % of its total sales ( 60 %, 14 % and 10 %) and the Company had revenue from two customers that exceeded
−Removed: 10 % of its total sales ( 58 %, 12 %) for the year ended December 31, 2020.
+Added: At December 31, 2022, there were no net accounts
+Added: receivable from a customer that exceeded 10 % of the Company’s accounts receivable and at December 31, 2021, one customer had exceeded
+Added: 10% of the Company’s accounts receivable ( 100 %).
+Added: During the year ended December 31, 2022, the Company had revenue from two customers
+Added: that exceeded 10 % of its total sales ( 55 % and 29 %) and the Company had revenue from three customers that exceeded 10 % of its total sales
+Added: ( 60 %, 14 % and 10 %) for the year ended December 31, 2021.
Note 11 — Leases:
3 unchanged sentences
a monthly average cost of approximately $ 17,000 commenced on September 16, 2020.
−Removed: The Company’s sublease on its previous premises
−Removed: at 400 Connell Drive, Berkeley Heights, New Jersey 07922 terminated on November 30, 2020.
The Company entered into an operating lease for
office space in Germany that began in July 2017.
−Removed: The rental agreement has a three-month term which automatically renews and includes
−Removed: a monthly cost of 400 Euros.
+Added: The rental agreement has a three-month term which automatically renews and includes a
+Added: monthly cost of 400 Euros.
The Company elected to apply the short-term practical expedient to the office lease.
−Removed: The Company also has
−Removed: an operating lease for office equipment.
+Added: The Company also has an
+Added: operating lease for office equipment.
Operating lease expense in the Company’s
3 unchanged sentences
a total operating lease liability of $ 803,000 and $ 924,000 , respectively.
−Removed: At December 31, 2021, approximately $ 122,000 and $ 802,000
−Removed: were classified as operating lease liabilities, short-term and operating lease liabilities, net of current portion, respectively, on the
−Removed: consolidated balance sheet.
+Added: At December 31, 2022, approximately $ 135,000 and $ 668,000 were
+Added: classified as operating lease liabilities, short-term and operating lease liabilities, net of current portion, respectively, on the consolidated
+Added: balance sheet.
Operating ROU assets as of December 31, 2022 and 2021 are $ 775,000 and $ 900,000 , respectively.
−Removed: CORMEDIX INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
For the year ended December 31, 2022 and 2021,
9 unchanged sentences
Less imputed interest
+Added: CORMEDIX INC.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS,
Note 12 — Subsequent Events:
−Removed: During the first quarter of 2022, the Company sold
−Removed: an aggregate of 641,542 shares of its common stock under the ATM program (see Note 7) and realized net proceeds of approximately $3.0
−Removed: As of the filing of this Annual Report on Form 10-K, the Company has $46.9 million available balance under its ATM program and
−Removed: it has $150.0 million available under its current shelf registration for the issuance of equity, debt or equity-linked securities.
−Removed: On March 16, 2022, the Company’s Board of Directors (the “Board”)
−Removed: appointed Joseph Todisco as the Company’s Chief Executive Officer, commencing on such date as mutually agreed by Mr.
−Removed: the Board, but in no event later than May 16, 2022.
−Removed: Todisco was appointed to serve as a member of the Board on March 18, 2022.
−Removed: Todisco will receive an annual salary of $ 600,000 , which may be adjusted from time to time.
−Removed: He will be eligible for an annual bonus, based
−Removed: on a target of 65 % of his base salary, as determined by the Board or the Compensation Committee of the Board (“Compensation Committee”).
−Removed: In determining such bonus, the Board or Compensation Committee will take into consideration the achievement of specified company objectives
−Removed: and personal objectives.
−Removed: Todisco generally must be employed through December 31 of a given year to earn that year’s annual bonus.
−Removed: Solely with respect to the 2022 fiscal year, Mr.
−Removed: Todisco will be paid an annual bonus in an amount that is not less than $ 195,000 (equal
−Removed: to 50 % of the 2022 target bonus amount).
−Removed: Effective as of the date Mr.
−Removed: Todisco’s employment with the Company commences (the “Start
−Removed: Date”), the Company will grant Mr.
−Removed: Todisco stock option to purchase 500,000 shares of the Company’s common stock, with an
−Removed: exercise price equal to the closing price of the Company’s stock on the date of grant.
−Removed: The option will vest over four years in four
−Removed: equal annual installments on the first four anniversaries of the Start Date, provided that Mr.
−Removed: Todisco remains an employee or consultant
−Removed: through the applicable vesting date.
−Removed: Todisco will also be granted 207,469 restricted stock units (“Initial RSUs”), which
−Removed: will vest as to 50 % on the first anniversary of the Start Date, as to 30 % on the second anniversary of the Start Date, and as to 20 % on
−Removed: the third anniversary of the Start Date, provided that Mr.
−Removed: Todisco remains an employee or consultant through the applicable vesting date.
−Removed: Matthew David will continue to serve as interim Chief Executive Officer and Chief Financial Officer until Mr.
−Removed: Todisco commences employment,
−Removed: after which Dr.
−Removed: David will continue to serve as the Company’s Chief Financial Officer.
−Removed: On March 28, 2022, the Company announced that the
−Removed: resubmission of the NDA for DefenCath has been accepted for filing by the FDA.
−Removed: The FDA considers the resubmission as a complete, Class
−Removed: 2 response with a six-month review cycle.
+Added: On January 15, 2023, the Company entered into an
+Added: employment agreement with Erin Mistry, pursuant to which she was promoted to the role of Executive Vice President and Chief Commercial
+Added: The Board further appointed Ms.
+Added: Mistry an officer, for purposes of Section 16 of the Securities Exchange Act of 1934.
+Added: Through March 30, 2023, the Company sold an aggregate of 1,684,592
+Added: shares of its common stock under the ATM program (see Note 9) and realized net proceeds of approximately $7,200,000.
+Added: As of the filing
+Added: of this Annual Report on Form 10-K, the Company has $24,200,000 available balance under its ATM program and it has $150,000,000 available
+Added: under its current shelf registration for the issuance of equity, debt or equity-linked securities.
+Added: On March 2, 2023, the Company provided regulatory
+Added: and manufacturing updates related to the FDA compliance remediation activities at its primary CMO and heparin API supplier, as well as
+Added: updated timelines for potential resubmission of its NDA under various scenarios.
+Added: More specifically:
+Added: 1) The Company has been informed by
+Added: its primary CMO (“CMO 1”) that all corrective actions stemming from the FDA’s June 2022 inspection have been completed
+Added: and the CMO has provided to FDA documentation showing effectiveness of the corrective actions.
+Added: The primary CMO awaits feedback from the
+Added: FDA with respect to the compliance status of the facility, and 2) The Company has been informed by its existing supplier of heparin API
+Added: (“API 1”) that all corrective actions related to its June 2022 FDA Warning Letter for a non-heparin API have been completed
+Added: and implementation is underway, however it is unclear to the Company based on recent FDA actions if full resolution of the outstanding
+Added: warning letter would still be required prior to approving the DefenCath NDA with reference to API 1.
+Added: The supplier has informed the Company
+Added: that it has made updates to the US Heparin Drug Master File (“DMF”) clarifying which activities take place at the site which
+Added: is identified in the warning letter (early-stage processing) and which activities take place at a different FDA registered facility (final
+Added: processing and release).
+Added: The supplier has also informed the Company that subsequent to those updates, a supplement to an approved application
+Added: referring to this DMF was recently approved by FDA.
+Added: Based on this recent approval and the update to the DMF, it is possible that full
+Added: resolution of the outstanding warning letter is no longer a barrier to FDA approval of the DefenCath NDA.
+Added: The Company intends to seek
+Added: confirmation from FDA on this issue set as follows:
+Added: Given the progress made by CMO 1 on remediation of the inspectional observations and
+Added: the potential precedent created by FDA’s approval of a supplement referencing the same heparin DMF utilized for DefenCath, the Company
+Added: has submitted a Type A meeting request seeking additional guidance from the FDA prior to resubmission of the NDA application.
+Added: granted the meeting request, and the meeting has been scheduled for mid-April.
+Added: On March 23, 2023, Plaintiffs filed a letter, attaching
+Added: a joint stipulation, requesting that the Voter v.
+Added: Baluch , et al ., Case No.
+Added: 2:21-cv-18493-JXN-LDW be re-opened and consolidated
+Added: with DeSalvo v.
+Added: Costa, et al., Case No.
+Added: 2:23-cv-00150-JXN-CLW and Scullion v.
+Added: Baluch, et al., Case No.
+Added: 2:23-cv-00406-ES-ESK
+Added: to consolidate all three derivative actions and continue the temporary stay for all three derivative actions.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.