3 unchanged sentences
The term “disclosure
−Removed: controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that
−Removed: it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms.
−Removed: Disclosure controls and procedures include, without limitation, controls and procedures
−Removed: designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal
−Removed: financial officers, as appropriate to allow timely decisions regarding required disclosure.
−Removed: Management recognizes that any set of controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of
−Removed: achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
−Removed: Based on the evaluation of our disclosure controls and procedures as of December 31, 2022,
−Removed: our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
+Added: controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it
+Added: files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms.
+Added: Disclosure controls and procedures include, without limitation, controls and procedures designed
+Added: to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial
+Added: officers, as appropriate to allow timely decisions regarding required disclosure.
+Added: Management recognizes that any set of controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their
+Added: objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
+Added: Based on the evaluation of our disclosure controls and procedures as of December 31, 2023, our Chief
+Added: Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Management’s Annual Report on Internal Control Over Financial Reporting
−Removed: The Management of ADMA Biologics, Inc.
−Removed: (the “Company”) is responsible for establishing and maintaining adequate internal control over financial reporting for the Company.
−Removed: Internal control over financial reporting is
−Removed: defined in Rule 13a-15(f) or 15d-15(f) promulgated under the Exchange Act, as amended, as a process designed by, or under the supervision of, the Company’s principal executive and principal financial officers and effected by the Company’s board
−Removed: of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with accounting principles generally
−Removed: accepted in the United States of America (“U.S.
−Removed: GAAP”) and includes those policies and procedures that:
−Removed: (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the
−Removed: assets of the Company;
−Removed: (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with U.S.
−Removed: GAAP, and that receipts and expenditures of our company are being made only
−Removed: in accordance with authorizations of management and directors of the Company;
−Removed: and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the Company’s assets that could have
−Removed: a material effect on the financial statements.
−Removed: Internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements prepared for external purposes in
−Removed: accordance with U.S.
−Removed: Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.
−Removed: Also, projections of any evaluation of effectiveness to future periods are subject to the risk that
−Removed: controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
−Removed: Management, with the participation of the Company’s Chief Executive Officer and Chief Financial Officer, assessed the effectiveness of its internal control over financial reporting as of December 31, 2022.
−Removed: this assessment, management used the criteria set forth in the Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.
−Removed: Based on its assessment, management concluded that the
−Removed: Company’s internal control over financial reporting was effective as of December 31, 2022 based on those criteria.
−Removed: As a Smaller Reporting Company, the Company is not required to include in this Annual Report on Form 10-K a report on the effectiveness of its internal control over financial reporting by the Company’s independent
−Removed: registered public accounting firm.
+Added: Management’s annual report on internal control over financial reporting (as defined in Rule 13a- 15(f) under the Exchange Act) is included with the financial statements reflected in Item 8 of this Annual Report on Form
+Added: 10-K and is incorporated herein by reference.
+Added: Report of Independent Registered Public Accounting Firm
+Added: The effectiveness of our internal control over financial reporting as of December 31, 2023 has been audited by CohnReznick LLP, an independent registered public accounting firm, as stated in their report which appears
+Added: in Item 8 of this Annual Report on Form 10-K.
Changes in Internal Control Over Financial Reporting
−Removed: There has been no change in our internal control over financial reporting during the quarter ended December 31, 2022 that has materially affected, or is reasonably likely to materially affect, our internal control
−Removed: over financial reporting.
+Added: There has been no change in our internal control over financial reporting during the quarter ended December 31, 2023 that has materially affected, or is reasonably likely to materially affect, our internal control over
+Added: financial reporting.
Other Information
1 unchanged sentence
Directors, Executive Officers and Corporate Governance
−Removed: Information required to be disclosed by this Item with respect to our executive officers is incorporated into this Annual Report on Form 10-K by reference from the section entitled “Executive Officers and Director
−Removed: and Officer Compensation:
+Added: Information required to be disclosed by this Item with respect to our executive officers is incorporated into this Annual Report on Form 10-K by reference from the section entitled “Executive Officers and Director and
+Added: Officer Compensation:
Executive Officers” contained in our definitive proxy statement for our 2024 annual meeting of stockholders, which we intend to file within 120 days of the end of our fiscal year ended December 31, 2023.
1 unchanged sentence
Election of Directors” contained in our definitive proxy statement for our 2024 annual meeting of stockholders, which we intend to file within 120 days of the end of our fiscal year ended December 31, 2023.
−Removed: To the extent necessary, information required to be disclosed by this Item about the Section 16(a) compliance of our directors and executive officers is incorporated into this Annual Report on
−Removed: Form 10-K, as applicable, by reference from the section entitled “Delinquent Section 16(a) Reports” contained in our definitive proxy statement for our 2023 annual meeting of stockholders, which we intend to file within 120 days of the end of our
−Removed: fiscal year ended December 31, 2022.
−Removed: Information required to be disclosed by this Item about our Board, the Audit Committee of our Board, our audit committee financial expert, our Code of Ethics and Business Conduct Standards, and other corporate
−Removed: governance matters is incorporated into this Annual Report on Form 10-K by reference from the section entitled “Corporate Governance” contained in our definitive proxy statement for our 2023 annual meeting of stockholders, which we intend to file
−Removed: within 120 days of the end of our fiscal year ended December 31, 2022.
−Removed: The text of our Code of Ethics and Business Conduct Standards, which applies to our directors and employees (including our principal executive officer, principal financial officer, principal accounting officer or
−Removed: controller and persons performing similar functions), is posted in the “Corporate Governance” section of the Investors section of our website, www.admabiologics.com.
−Removed: A copy of the Code of Ethics and Business Conduct Standards can be obtained free
−Removed: of charge on our website.
−Removed: We intend to disclose on our website any amendments to, or waivers from, our Code of Ethics and Business Conduct Standards that are required to be disclosed pursuant to the rules of the SEC and The Nasdaq Stock Market.
+Added: To the extent necessary, information required to be disclosed by this Item about the Section 16(a) compliance of our directors and executive officers is incorporated into this Annual Report on Form
+Added: 10-K, as applicable, by reference from the section entitled “Delinquent Section 16(a) Reports” contained in our definitive proxy statement for our 2024 annual meeting of stockholders, which we intend to file within 120 days of the end of our fiscal
+Added: year ended December 31, 2023.
+Added: Information required to be disclosed by this Item about our Board, the Audit Committee of our Board, our audit committee financial expert, our Code of Ethics and Business Conduct, and other corporate governance matters
+Added: is incorporated into this Annual Report on Form 10-K by reference from the section entitled “Corporate Governance” contained in our definitive proxy statement for our 2024 annual meeting of stockholders, which we intend to file within 120 days of
+Added: the end of our fiscal year ended December 31, 2023.
+Added: The text of our Code of Ethics and Business Conduct, which applies to our directors and employees (including our principal executive officer, principal financial officer, principal accounting officer or controller and
+Added: persons performing similar functions), is posted in the “Corporate Governance” section of the Investors section of our website, www.admabiologics.com.
+Added: A copy of the Code of Ethics and Business Conduct can be obtained free of charge on our website.
+Added: We intend to disclose on our website any amendments to, or waivers from, our Code of Ethics and Business Conduct that are required to be disclosed pursuant to the rules of the SEC and The Nasdaq Stock Market.
The information presented on our website is not a part of this Annual Report on Form 10-K and the reference to our website is intended to be an inactive textual reference only.
Executive Compensation
−Removed: Information required to be disclosed by this Item is incorporated into this Annual Report on Form 10-K by reference from the section entitled “Executive Officers and Director and Officer Compensation” contained in
−Removed: our definitive proxy statement for our 2023 annual meeting of stockholders, which we intend to file within 120 days of the end of our fiscal year ended December 31, 2022.
+Added: Information required to be disclosed by this Item is incorporated into this Annual Report on Form 10-K by reference from the section entitled “Executive Officers and Director and Officer Compensation” contained in our
+Added: definitive proxy statement for our 2024 annual meeting of stockholders, which we intend to file within 120 days of the end of our fiscal year ended December 31, 2023.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
−Removed: Information required to be disclosed by this Item is incorporated into this Annual Report on Form 10-K by reference from the sections entitled “Security Ownership of Certain Beneficial Owners and Management and
−Removed: Related Stockholder Matters” contained in our definitive proxy statement for our 2023 annual meeting of stockholders, which we intend to file within 120 days of the end of our fiscal year ended December 31, 2022.
+Added: Information required to be disclosed by this Item is incorporated into this Annual Report on Form 10-K by reference from the sections entitled “Security Ownership of Certain Beneficial Owners and Management and Related
+Added: Stockholder Matters” contained in our definitive proxy statement for our 2024 annual meeting of stockholders, which we intend to file within 120 days of the end of our fiscal year ended December 31, 2023.
Certain Relationships and Related Transactions, and Director Independence
8 unchanged sentences
(1) Consolidated Financial Statements.
−Removed: Report of Independent Registered Public Accounting Firm
+Added: Management’s Annual Report on Internal Control Over Financial Reporting
+Added: Report of Independent Registered Public Accounting Firm (PCAOB ID 596)
Consolidated Balance Sheets as of December 31, 2023 and 2022
7 unchanged sentences
INDEX TO EXHIBITS
−Removed: Master Purchase and Sale Agreement, dated as of January 21, 2017, by and among Biotest Pharmaceuticals Corporation, ADMA BioManufacturing, LLC, ADMA Biologics, Inc., Biotest AG and Biotest US Corporation (incorporated herein by
−Removed: reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K, filed with the SEC on January 23, 2017).
Second Amended and Restated Certificate of Incorporation of the Company (incorporated herein by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K, filed with the SEC on August 23, 2019).
−Removed: Certificate of Amendment of the Second Amended and Restated Certificate of Incorporation of ADMA Biologics, Inc., dated as of May 27, 2021 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on
−Removed: May 28, 2021).
+Added: Certificate of Amendment of the Second Amended and Restated Certificate of Incorporation of ADMA Biologics, Inc., dated as of May 27, 2021 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on May
Amended and Restated Bylaws (incorporated herein by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K, filed with the SEC on October 7, 2016).
3 unchanged sentences
1 to the Company’s Current Report on Form 8-K/A, filed with the SEC on March 29, 2012).
−Removed: Warrant Agreement, dated December 21, 2012, issued by the Company to Hercules Technology Growth Capital, Inc.
−Removed: (incorporated herein by reference to Exhibit 4.3 to the Company’s Registration Statement on Form S-1, filed with the SEC on
−Removed: February 11, 2013).
Form of Warrant Agreement, dated May 13, 2016, issued by the Company to Oxford Finance LLC (incorporated herein by reference to Exhibit 4.6 to the Company’s Quarterly Report on Form 10-Q, filed with the SEC on May 13, 2016).
6 unchanged sentences
filed with the SEC on March 24, 2021).
−Removed: Note, dated February 11, 2019, issued by the Company to Perceptive Credit Holdings II, LP (incorporated herein by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K, filed with the SEC on February 12, 2019).
−Removed: Note, dated May 3, 2019, issued by the Company to Perceptive Credit Holdings II, LP (incorporated herein by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K, filed with the SEC on May 3, 2019).
−Removed: Note, dated December 8, 2020, issued by the Company to Perceptive Credit Holdings II, L.P.
−Removed: (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on December 9, 2020).
Description of Securities Registered under Section 12 of the Securities Exchange Act of 1934 (incorporated by reference to Exhibit 4.11 to the Company’s Annual Report on Form 10-K, filed with the SEC on March 24, 2022).
−Removed: Form of Warrant to Purchase Stock, in the form issued by the Company to various entities affiliated with Hayfin Services LLP, dated as of March 23, 2022 (incorporated by reference to Exhibit 4.13 to the Company’s Annual Report on Form
−Removed: 10-K, filed with the SEC on March 24, 2022).
+Added: Form of Warrant to Purchase Common Stock, in the form issued by the Company to various entities affiliated with Hayfin Services LLP, dated as of March 23, 2022 (incorporated by reference to Exhibit 4.13 to the Company’s Annual Report on
+Added: Form 10-K, filed with the SEC on March 24, 2022).
+Added: Form of Warrant to Purchase Common Stock, in the form issued by the Company to various entities affiliated with Hayfin Services LLP, dated as of May 1, 2023 (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on
+Added: Form 8-K, filed with the SEC on May 2, 2023).
2007 Employee Stock Option Plan, as amended by Amendment No.
3 unchanged sentences
Amended and Restated Employment Agreement, dated January 29, 2019, by and between ADMA Biologics, Inc.
−Removed: and Adam Grossman (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed with the SEC
−Removed: on January 29, 2019).
+Added: and Adam Grossman (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed with the SEC on
+Added: January 29, 2019).
Amendment to Employment Agreement, dated as of September 29, 2021, by and between ADMA Biologics, Inc.
2 unchanged sentences
Amended and Restated Employment Agreement, dated January 29, 2019, by and between ADMA Biologics, Inc.
−Removed: and Brian Lenz (incorporated herein by reference to Exhibit 10.3 to the Company’s
−Removed: Current Report on Form 8-K, filed with the SEC on January 29, 2019).
+Added: and Brian Lenz (incorporated herein by reference toExhibit 10.3 to the Company’s Current Report on Form 8-K, filed with the SEC on
+Added: January 29, 2019).
Amendment to Employment Agreement, dated as of September 29, 2021, by and between ADMA Biologics, Inc.
5 unchanged sentences
Second Amendment to Plasma Purchase Agreement, dated as of December 18, 2015, by and between Biotest Pharmaceuticals Corporation and ADMA Biologics, Inc.
−Removed: (incorporated herein by reference to Exhibit 10.3.1 to the Company’s Annual
−Removed: Report on Form 10-K, filed with the SEC on March 23, 2016).
+Added: (incorporated herein by reference to Exhibit 10.3.1 to the Company’s Annual Report
+Added: on Form 10-K, filed with the SEC on March 23, 2016).
Third Amendment to Plasma Purchase Agreement, dated as of April 8, 2016, by and between Biotest Pharmaceuticals Corporation and ADMA Biologics, Inc.
−Removed: (incorporated herein by reference to Exhibit 10.3.2 to the Company’s Quarterly Report
−Removed: on Form 10-Q, filed with the SEC on May 13, 2016).
+Added: (incorporated herein by reference to Exhibit 10.3.2 to the Company’s Quarterly Report on
+Added: Form 10-Q, filed with the SEC on May 13, 2016).
Fourth Amendment to Plasma Purchase Agreement, dated as of June 6, 2017, by and between Biotest Pharmaceuticals Corporation and ADMA Biologics, Inc.
4 unchanged sentences
herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed with the SEC on January 2, 2019).
−Removed: Plasma Supply Agreement, dated as of June 6, 2017, by and between ADMA BioManufacturing, LLC and Biotest Pharmaceuticals Corporation (incorporated herein by reference to Exhibit 10.5 to the Company’s Quarterly Report on Form 10-Q,
−Removed: filed with the SEC on August 11, 2017).
−Removed: Amendment #1 to the Plasma Supply Agreement, dated as of July 19, 2018, by and between Biotest Pharmaceuticals Corporation and ADMA BioManufacturing, LLC (incorporated herein by reference to Exhibit 10.2 to the Company’s Quarterly
−Removed: Report on Form 10-Q, filed with the SEC on August 10, 2018).
−Removed: Plasma Purchase Agreement, dated as of June 6, 2017, by and between ADMA BioManufacturing, LLC and Biotest Pharmaceuticals Corporation (incorporated herein by reference to Exhibit 10.6 to the Company’s Quarterly Report on Form 10-Q,
−Removed: filed with the SEC on August 11, 2017).
−Removed: Amendment to Plasma Purchase Agreement, dated as of July 19, 2018, by and between Biotest Pharmaceuticals Corporation and ADMA BioManufacturing, LLC (incorporated herein by reference to Exhibit 10.3 to the Company’s Quarterly Report on
+Added: Plasma Supply Agreement, dated as of June 6, 2017, by and between ADMA BioManufacturing, LLC and Biotest Pharmaceuticals Corporation (incorporated herein by reference to Exhibit 10.5 to the Company’s Quarterly Report on Form 10-Q, filed
+Added: with the SEC on August 11, 2017).
+Added: Amendment #1 to the Plasma Supply Agreement, dated as of July 19, 2018, by and between Biotest Pharmaceuticals Corporation and ADMA BioManufacturing, LLC (incorporated herein by reference to Exhibit 10.2 to the Company’s Quarterly Report
+Added: on Form 10-Q, filed with the SEC on August 10, 2018).
+Added: Amended and Restated Agreement for Services, effective as of January 1, 2016, as amended, by and between ADMA BioManufacturing, LLC and Areth LLC (incorporated herein by reference to Exhibit 10.18 to the Company’s Quarterly Report on
Form 10-Q, filed with the SEC on August 12, 2016).
−Removed: Amended and Restated Agreement for Services, effective as of January 1, 2016, as amended, by and between ADMA Biologics, LLC and Areth LLC (incorporated herein by reference to Exhibit 10.18 to the Company’s Quarterly Report on Form
−Removed: 10-Q, filed with the SEC on August 12, 2016).
−Removed: Lease, effective as of February 17, 2017, by and between Home Center Properties, LLC and ADMA BioCenters Georgia Inc.
−Removed: (incorporated herein by reference to Exhibit 10.22 to the Company’s Annual Report on Form 10-K, filed with the SEC on
−Removed: February 24, 2017).
Form of Indemnification Agreement (incorporated herein by reference to Exhibit 10.12 to the Company’s Current Report on Form 8-K, filed with the SEC on February 13, 2012).
−Removed: Credit Agreement and Guaranty, dated as of February 11, 2019, by and among the Company, ADMA Plasma Biologics, Inc., ADMA BioCenters Georgia Inc., ADMA BioManufacturing, LLC, and Perceptive Credit Holdings II, LP.
−Removed: (incorporated herein
−Removed: by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed with the SEC on February 12, 2019).
−Removed: Amendment No.
−Removed: 1 to Credit Agreement and Guaranty, dated as of May 3, 2019, by and among the Company, ADMA Plasma Biologics, Inc., ADMA BioCenters Georgia Inc., ADMA BioManufacturing, LLC and Perceptive Credit Holdings II, LP
−Removed: (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on May 3, 2019).
−Removed: Amendment No.
−Removed: 2 to the Credit Agreement and Guaranty, dated December 8, 2020, by and among the Company, ADMA Plasma Biologics, Inc., ADMA BioCenters Georgia Inc., ADMA BioManufacturing, LLC and Perceptive Credit Holdings II, LP.
−Removed: (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on December 9, 2020).
−Removed: Security Agreement, dated as of February 11, 2019, by and among the Company, ADMA Plasma Biologics, Inc., ADMA Bio Centers Georgia Inc., ADMA BioManufacturing, LLC, and Perceptive Credit Holdings II, LP.
−Removed: (incorporated herein by
−Removed: reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K, filed with the SEC on February 12, 2019).
License Agreement, effective as of December 31, 2012, by and between ADMA Biologics, Inc.
2 unchanged sentences
First Amendment to License Agreement, dated as of June 6, 2017, by and between the Company and Biotest AG (incorporated herein by reference to Exhibit 10.8 to the Company’s Quarterly Report on Form 10-Q, filed with the SEC on August 11,
−Removed: Manufacturing Agreement, dated as of September 30, 2011, by and between ADMA BioManufacturing, LLC (as successor-in-interest to Biotest Pharmaceuticals Corporation) and Sanofi Pasteur S.A.
−Removed: (incorporated herein by reference to Exhibit
−Removed: 10.24 to the Company’s Annual Report on Form 10-K, filed with the SEC on March 29, 2018).
−Removed: Amendment #2 to the Manufacturing Agreement, effective as of August 1, 2016, by and between ADMA BioManufacturing, LLC (as successor-in-interest to Biotest Pharmaceuticals Corporation) and Sanofi Pasteur S.A.
−Removed: (incorporated herein by
−Removed: reference to Exhibit 10.24.1 to the Company’s Annual Report on Form 10-K, filed with the SEC on March 29, 2018).
−Removed: Amendment #3 to the Manufacturing Agreement, effective as of December 21, 2017, by and between ADMA BioManufacturing, LLC and Sanofi Pasteur S.A.
−Removed: (incorporated herein by reference to Exhibit 10.24.2 to the Company’s Annual Report on
−Removed: Form 10-K, filed with the SEC on March 29, 2018).
−Removed: Stockholders Agreement, dated as of June 6, 2017, by and between the Company and Biotest Pharmaceuticals Corporation (incorporated herein by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K, filed with the SEC on
−Removed: June 12, 2017).
−Removed: Transition Services Agreement, dated as of January 1, 2019, by and between the Company and Biotest Pharmaceuticals Corporation (incorporated herein by reference to Exhibit 10.22 to the Company’s Annual Report on Form 10-K, filed with
−Removed: the SEC on March 13, 2019).
−Removed: Amendment #1 to Transition Services Agreement, dated as of August 29, 2019, by and between ADMA BioManufacturing, LLC and Biotest Pharmaceuticals Corporation (incorporated by reference from Exhibit 10.1 to Current Report on Form 8-K,
−Removed: filed on September 5, 2019).
−Removed: Amendment 3 to the Amended and Restated Agreement for Services, effective as of November 7, 2019, by and between ADMA Biologics, LLC and Areth LLC (incorporated herein by reference to the Exhibit 10.27 to the Company’s Annual Report on
−Removed: Form 10-K filed March 12, 2020).
+Added: Amendment 3 to the Amended and Restated Agreement for Services, effective as of November 7, 2019, by and between ADMA BioManufacturing, LLC and Areth LLC (incorporated herein by reference to the Exhibit 10.27
+Added: to the Company’s Annual Report on Form 10-K filed March 12, 2020).
Amendment 4 to the Amended and Restated Agreement For Services Between ADMA BioManufacturing, LLC and Areth LLC (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed on November 9, 2022).
3 unchanged sentences
Form of Retention Bonus Agreement (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on October 1, 2021).
−Removed: Separation Agreement and Release, dated August 6, 2021, by and between ADMA Biologics, Inc.
−Removed: and James Mond (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed on August 11, 2021).
−Removed: Credit Agreement and Guaranty, dated as of March 23, 2022, by and among the Company, Hayfin Services LLP and the lenders party thereto (incorporated by reference to Exhibit 10.24 to the Company’s Annual Report on Form 10-K, filed with
−Removed: the SEC on March 24, 2022).
−Removed: Amendment No.
−Removed: 1 to Credit Agreement and Guaranty, dated March 23, 2023 by and among the Company, Hayfin Services LLP and the lenders party thereto.
−Removed: Security Agreement, dated as of March 23, 2022, by and among the Company, certain subsidiaries of the Company and Hayfin Services LLP (incorporated by reference to Exhibit 10.25 to the Company’s Annual Report on Form 10-K, filed with
−Removed: the SEC on March 24, 2022).
ADMA Biologics, Inc.
2022 Equity Compensation Plan (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed with the Commission on June 21, 2022)
+Added: Credit Agreement, dated as of December 18, 2023, by and among the Company, as Administrative Borrower, ADMA BioManufacturing, LLC, ADMA Plasma Biologics, Inc.
+Added: and ADMA BioCenters Georgia Inc., each as Borrowers, certain subsidiaries of
+Added: the Company, as Guarantors, from time to time party thereto, the Lenders from time to time party thereto, Ares Capital Corporation, as Administrative Agent and as Collateral Agent, and ACF FINCO I LP, as Revolving Agent (incorporated herein
+Added: by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed with the Commission on December 18, 2023)
+Added: Security Agreement, dated as of December 18, 2023, by and among the Company, ADMA BioManufacturing, LLC, ADMA Plasma Biologics, Inc.
+Added: and ADMA BioCenters Georgia, Inc., as Grantors, and Ares Capital Corporation, as Collateral Agent
+Added: (incorporated herein by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed with the Commission on December 18, 2023)
Subsidiaries of the Company.
6 unchanged sentences
Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
+Added: ADMA Biologics, Inc.
+Added: Compensation Recoupment Policy
The following materials from ADMA Biologics, Inc.
1 unchanged sentence
(i) Consolidated Balance Sheets at December 31, 2023 and December 31, 2022,
−Removed: (ii) Consolidated Statements of Operations for the years ended December 31, 2022 and 2021, (iii) Consolidated Statements of Changes in Stockholders’ Equity for the years ended December 31, 2022 and 2021, (iv) Consolidated Statements of
−Removed: Cash Flows for the years ended December 31, 2022 and 2021;
+Added: (ii) Consolidated Statements of Operations for the years ended December 31, 2023, 2022 and 2021, (iii) Consolidated Statements of Changes in Stockholders’ Equity for the years ended December 31, 2023, 2022 and 2021, (iv) Consolidated
+Added: Statements of Cash Flows for the years ended December 31, 2023, 2022 and 2021;
and (v) Notes to Consolidated Financial Statements.
9 unchanged sentences
ADMA Biologics, Inc.
−Removed: March 23, 2023
+Added: February 28, 2024
President and Chief Executive Officer
1 unchanged sentence
President and Chief Executive Officer (Principal Executive Officer) and Director
−Removed: March 23, 2023
+Added: February 28, 2024
/s/ Brian Lenz
Executive Vice President and Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)
−Removed: March 23, 2023
+Added: February 28, 2024
/s/ Steven A.
Chairman of the Board of Directors
−Removed: March 23, 2023
+Added: February 28, 2024
Vice Chairman of the Board of Directors
−Removed: March 23, 2023
−Removed: /s/ Martha J.
−Removed: March 23, 2023
+Added: February 28, 2024
+Added: /s/ Alison Finger
+Added: Alison Finger
+Added: February 28, 2024
/s/ Bryant E.
−Removed: March 23, 2023
+Added: February 28, 2024
/s/ Lawrence P.
−Removed: March 23, 2023
−Removed: March 23, 2023
+Added: February 28, 2024
+Added: February 28, 2024
ADMA BIOLOGICS, INC.
1 unchanged sentence
CONSOLIDATED FINANCIAL STATEMENTS
+Added: Management’s Annual Report on Internal Control Over Financial Reporting
Report of Independent Registered Public Accounting Firm (PCAOB ID 596 )
4 unchanged sentences
Notes to Consolidated Financial Statements
+Added: Management’s Annual Report on Internal Control Over Financial Reporting
+Added: The Management of ADMA Biologics, Inc.
+Added: (the “Company”) is responsible for establishing and maintaining adequate internal control over financial reporting for the Company.
+Added: Internal control over financial reporting is defined in
+Added: Rule 13a-15(f) or 15d-15(f) promulgated under the Securities Exchange Act of 1934, as amended, as a process designed by, or under the supervision of, the Company’s principal executive and principal financial officers and effected by the Company’s
+Added: Board of Directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with accounting principles
+Added: generally accepted in the United States of America (“U.S.
+Added: GAAP”) and includes those policies and procedures that:
+Added: (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions
+Added: of the assets of the Company;
+Added: (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with U.S.
+Added: GAAP, and that receipts and expenditures of our Company are being made
+Added: only in accordance with authorizations of management and Directors of the Company;
+Added: and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of our Company’s assets that could
+Added: have a material effect on the financial statements.
+Added: Internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements prepared for external purposes in
+Added: accordance with U.S.
+Added: Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.
+Added: Also, projections of any evaluation of effectiveness to future periods are subject to the risk that
+Added: controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
+Added: Management, with the participation of the Company’s Chief Executive Officer and Chief Financial Officer, assessed the effectiveness of its internal control over financial reporting as of December 31, 2023.
+Added: In making this
+Added: assessment, management used the criteria set forth in the Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.
+Added: Based on its assessment, management concluded that the Company’s
+Added: internal control over financial reporting was effective as of December 31, 2023 based on those criteria.
+Added: Our independent registered public accounting firm, which has audited the consolidated financial statements included in this Annual Report on Form 10-K, has also issued an audit report on the effectiveness of our internal
+Added: control over financial reporting as of December 31, 2023.
+Added: Their report appears on page F-3 of this Annual Report on Form 10-K.
+Added: /s/ Brian Lenz
+Added: President and Chief Executive Officer
+Added: Executive Vice President and Chief Financial Officer
+Added: February 28, 2024
+Added: February 28, 2024
Report of Independent Registered Public Accounting Firm
−Removed: To the Board of Directors and
−Removed: Stockholders of ADMA Biologics, Inc.
−Removed: Opinion on the Financial Statements
+Added: Board of Directors and Stockholders
+Added: ADMA Biologics, Inc.
+Added: Opinion on the Consolidated Financial Statements and Internal Control Over Financial Reporting
We have audited the accompanying consolidated balance sheets of ADMA Biologics, Inc.
−Removed: and subsidiaries (the “Company”) as of December 31, 2022 and 2021;
−Removed: consolidated statements of operations, changes in stockholders’ equity, and cash flows for the years then ended;
−Removed: and, the related notes (collectively referred to as the “consolidated financial statements”).
−Removed: In our opinion, the consolidated
−Removed: financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for the years then ended in conformity with accounting
−Removed: principles generally accepted in the United States of America.
+Added: and subsidiaries (the “Company”) as of December 31, 2023 and 2022, and the
+Added: related consolidated statements of operations, changes in stockholders’ equity, and cash flows for each of the years in the three-year period ended December 31, 2023 and the related notes and financial statement schedule II – valuation and
+Added: qualifying accounts (collectively referred to as the “consolidated financial statements”).
+Added: We also have audited the Company’s internal control over financial reporting as of December 31, 2023, based on criteria established in Internal
+Added: Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.
+Added: In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of
+Added: December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the years in the three-year period ended December 31, 2023, in conformity with accounting principles generally accepted in the United States of
+Added: Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control-Integrated Framework (2013) issued
+Added: by the Committee of Sponsoring Organizations of the Treadway Commission.
Basis for Opinion
−Removed: 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
−Removed: financial statements based on our audits.
−Removed: We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with
+Added: The Company’s management is responsible for these consolidated financial statements, for maintaining effective internal control over financial reporting, and for
+Added: its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s Annual Report on Internal Control over Financial Reporting.
+Added: Our responsibility is to express opinions on the entity’s
+Added: consolidated financial statements and on the entity’s internal control over financial reporting based on our audits.
+Added: We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and
+Added: are required to be independent with respect to the Company in accordance with the U.S.
federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB.
−Removed: Those standards require that we plan and perform the audit to obtain reasonable assurance
−Removed: about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.
−Removed: The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial
−Removed: As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial
−Removed: Accordingly, we express no such opinion.
−Removed: Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and
−Removed: performing procedures that respond to those risks.
+Added: Those standards require that we plan and perform the audits to obtain reasonable assurance
+Added: about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud, and whether effective internal control over financial reporting was maintained in all material respects.
+Added: Our audits of the consolidated financial statements included performing procedures to assess the risks of material misstatement of the consolidated financial
+Added: statements, whether due to error or fraud, and performing procedures that respond to those risks.
Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements.
−Removed: Our audits also included evaluating the accounting
−Removed: 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 our opinion.
+Added: Our audits 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.
+Added: Our audit of internal control over
+Added: financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control
+Added: based on the assessed risk.
+Added: Our audits also included performing such other procedures as we considered necessary in the circumstances.
+Added: We believe that our audits provide a reasonable basis for our opinions.
+Added: Definition and Limitations of Internal Control Over Financial Reporting
+Added: An entity’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and
+Added: the preparation of consolidated financial statements for external purposes in accordance with accounting principles generally accepted in the United States of America.
+Added: An entity’s internal control over financial reporting includes those
+Added: policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the entity;
+Added: (ii) provide reasonable assurance that
+Added: transactions are recorded as necessary to permit preparation of consolidated financial statements in accordance with accounting principles generally accepted in the United States of America, and that receipts and expenditures of the entity
+Added: are being made only in accordance with authorizations of management and directors of the entity;
+Added: and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the entity’s
+Added: assets that could have a material effect on the consolidated financial statements.
+Added: Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.
+Added: Also, projections of any evaluation of
+Added: effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Critical Audit Matters
−Removed: The critical audit matters communicated below are matters arising from 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 especially challenging, subjective, or complex judgments.
−Removed: The communication of critical audit matters does not alter in
−Removed: any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing a separate opinion on the critical audit matters or on the accounts or disclosures to
−Removed: which they relate.
+Added: The critical audit matters communicated below are matters arising from the current period audit of the consolidated financial statements that were communicated or
+Added: required to be communicated to the audit committee and that:
+Added: (i) relate to accounts or disclosures that are material to the consolidated financial statements and (ii) involved our especially challenging, subjective, or complex judgments.
+Added: communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the
+Added: critical audit matters or on the accounts or disclosures to which they relate.
+Added: Valuation of Inventory
Description of the matter
−Removed: As of December 31, 2022, the Company’s inventory totaled $163,280,047.
−Removed: As described in the notes to the consolidated financial statements, the valuation of inventory
−Removed: involves significant estimates relating to the capitalization of labor and overhead costs to the work in process and finished goods inventories as well as lower of cost or net realizable value considerations.
−Removed: Given the significance of the
−Removed: inventory value, the importance of inventory to the Company’s operations, the various components and the multiple locations and the complexity of the computations, auditing the inventory was challenging and involved a relatively high degree of
−Removed: auditor judgement and subjectivity, extensive testing, and the involvement of more senior members of the engagement team to design the appropriate responsive audit procedures and to supervise, execute and review the test results.
+Added: As of December 31, 2023, the Company’s inventory totaled $172.9 million.
+Added: As described in the notes to the consolidated financial statements, the valuation of
+Added: inventory involves significant estimates relating to the capitalization of labor and overhead costs to the work in process and finished goods inventories as well as lower of cost or net realizable value considerations.
+Added: Given the significance of
+Added: the inventory value, the importance of inventory to the Company’s operations, the various components and the multiple locations and the complexity of the computations, auditing the inventory was challenging and involved a relatively high degree
+Added: of auditor judgment and subjectivity, extensive testing, and the involvement of more senior members of the engagement team to design the appropriate responsive audit procedures and to supervise, execute and review the test results.
How we addressed the matter in our audit
−Removed: We obtained an understanding of and tested the Company’s process to estimate labor and overhead in the inventory to devise our responsive audit approach.
−Removed: performed substantive test procedures relating to the inventory valuation, which included verifying significant components of the valuation to supporting records, assessing the application of direct labor costs included in the valuation and
−Removed: assessing the appropriateness of the components of the indirect overhead pools as well as the application of such pool to the valuation.
−Removed: We verified the completeness and accuracy of the data used in management’s valuation and the mathematical
−Removed: accuracy of the direct labor and overhead applications.
−Removed: To assess management’s assertion that inventory is carried at the lower of cost or net realizable value, we tested subsequent sales transactions and net sales proceeds.
−Removed: Sales Rebate Liabilities
+Added: We obtained an understanding of, and tested controls related to the Company’s process to estimate labor and overhead in the inventory as well as controls over
+Added: estimating the lower of cost or net realizable value.
+Added: We performed substantive procedures relating to the inventory valuation, which included verifying significant components of the valuation to supporting records, assessing the application of
+Added: direct labor costs included in the valuation and assessing the appropriateness of the components of the indirect overhead pools as well as the application of such pool to the valuation.
+Added: We tested the completeness and accuracy of the data used
+Added: in management’s valuation and the mathematical accuracy of the direct labor and overhead applications.
+Added: To assess management’s assertion that inventory is carried at the lower of cost or net realizable value, we tested subsequent sales
+Added: transactions and net sales proceeds.
+Added: Variable Consideration Estimates - Rebates
Description of the matter
−Removed: As disclosed in Note 2 to the consolidated financial statements, revenue from the sale of the Company’s products is recorded net of estimated rebates, price protection arrangements and customer incentives, including prompt pay discounts,
−Removed: wholesaler chargebacks and other wholesaler fees.
−Removed: Estimated rebates are also attributable to government programs that mandate various reductions from list price, which are reflected as liabilities and settled through cash payments.
−Removed: Auditing the sales rebate liabilities related to U.S.
−Removed: Medicaid, Medicare Part D, and managed care is complex because of the subjectivity of certain assumptions
−Removed: and judgments required to develop estimates.
−Removed: These significant assumptions and judgments include consideration of legal interpretations of applicable laws and regulations, historical claims experience, payer channel mix, current contract
−Removed: prices, unbilled claims and claims submission time lags.
+Added: As disclosed in Note 2 to the consolidated financial statements, revenue from the sale of the Company’s products is recorded net of estimated rebates, price
+Added: protection arrangements and customer incentives, including prompt pay discounts, wholesaler chargebacks and other wholesaler fees.
+Added: Estimated rebates are also attributable to government programs that mandate various reductions from list price,
+Added: which are reflected as liabilities and settled through cash payments.
+Added: Auditing the variable consideration estimates, more specifically rebates related to U.S.
+Added: Medicaid, Medicare Part D, and managed care is complex because of the
+Added: subjectivity of certain assumptions and judgements required to develop estimates.
+Added: These significant assumptions and judgments include consideration of legal interpretations of applicable laws and regulations, historical claims experience, payer
+Added: channel mix, current contract prices, unbilled claims and claims submission time lags.
Additionally, auditing this matter is challenging given the Company’s limited history in selling certain of its products.
How we addressed the matter in our audit
−Removed: We obtained an understanding of the Company’s process to estimate rebate liabilities to devise our responsive audit approach.
−Removed: We performed substantive test procedures related to the rebate accruals, which included testing the significant
−Removed: assumptions and mathematical accuracy.
−Removed: We tested the completeness and accuracy of the data used in the estimates and developed expectations of the key inputs using independent sources.
−Removed: To address the completeness of the reserves, we also
−Removed: assessed the historical accuracy of management’s estimates by comparing actual activity to previous estimates and performing analytical procedures.
−Removed: Finally, we considered subsequent events and any new information after the financial statement
−Removed: date that would require an adjustment to the accruals.
−Removed: Liquidity Analysis
−Removed: Description of the matter
−Removed: The Company asserts that the cash on hand and certain other sources of funding as described in Note 1 to the consolidated financial statements provide sufficient liquidity to satisfy obligations for at least one year from the date of
−Removed: issuance of these consolidated financial statements.
−Removed: We concluded that liquidity considerations involved in the Company’s ability to continue as a going concern are complex and therefore a critical audit matter as such are complex.
−Removed: there is a high degree of subjectivity in the estimates prepared by management and in our selection of appropriate audit procedures, resulting in this to be a challenging audit area.
−Removed: How we addressed the matter in our audit
−Removed: We obtained an understanding the Company’s process to prepare cash flow projections to devise our responsive audit approach.
−Removed: We obtained and audited management’s projections, considering their completeness with respect to cash obligations.
−Removed: Through cumulative audit knowledge, we applied judgement in obtaining evidence to support the projections and scrutinized the sources and probability of realization of the projected funds.
−Removed: We compared the data provided to sensitivity adjusted
−Removed: projections, made inquiries of management and applied our industry knowledge.
−Removed: Finally, we considered management’s overall ability to put forth reasonable projections based on the performance of retrospective audit procedures on historic cash
−Removed: flow projections and based on the results of audit procedures applied to other estimates .
+Added: We obtained an understanding of, and tested controls related to the Company’s process to estimate variable consideration as it relates to rebates, specifically
+Added: Medicaid, Medicare Part D and managed care.
+Added: We performed a combination of substantive procedures including recalculations of the percentages of rebates processed against related rebate eligible revenue for certain products, confirmations
+Added: of underlying data used in the calculations and an evaluation of actual rebates processed against historical estimates.
+Added: Our testing focused on the appropriateness of significant assumptions and mathematical accuracy used in the calculation and
+Added: the completeness and accuracy of the data used in the estimates.
+Added: To address the completeness of the reserves, we also assessed the historical accuracy of management’s estimates by comparing actual activity to previous estimates (lookback).
+Added: Finally, we considered subsequent events and any new information after the financial statement date that would require an adjustment to the accruals.
/s/ CohnReznick LLP
1 unchanged sentence
Parsippany, New Jersey
−Removed: March 23, 2023
+Added: February 28, 2024
ADMA BIOLOGICS, INC.
1 unchanged sentence
BALANCE SHEETS
−Removed: December 31, 2022 and 2021
+Added: Years Ended December 31, 2023 and 2022
+Added: (In thousands, except share data)
Current assets:
28 unchanged sentences
Accumulated deficit
−Removed: ( 478,016,671
−Removed: ( 412,112,721
TOTAL STOCKHOLDERS’ EQUITY
4 unchanged sentences
CONSOLIDATED STATEMENTS OF
−Removed: Years Ended December 31, 2022 and 2021
Years ended December 31,
−Removed: Product revenue
−Removed: License revenue
−Removed: Total revenues
+Added: (In thousands, except share and per share data)
Cost of product revenue
5 unchanged sentences
Total operating expenses
−Removed: LOSS FROM OPERATIONS
+Added: INCOME (LOSS) FROM OPERATIONS
OTHER INCOME (EXPENSE):
10 unchanged sentences
AND SUBSIDIARIES
−Removed: CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’
−Removed: Years Ended December 31, 2022 and 2021
+Added: CONSOLIDATED STATEMENTS OF CHANGES IN
STOCKHOLDERS’
+Added: (In thousands, except share data)
+Added: Stockholders’
Balance at December 31, 2020
−Removed: ( 340,465,103
Stock-based compensation
2 unchanged sentences
Balance at December 31, 2021
−Removed: ( 412,112,721
Stock-based compensation
+Added: Issuance of common stock, net of offering expenses
+Added: Vesting of Restricted Stock Units, net of shares withheld for taxes
Warrants issued in connection with note payable
+Added: Exercise of stock options
+Added: Balance at December 31, 2022
+Added: Stock-based compensation
Vesting of Restricted Stock Units, net of shares withheld for taxes
−Removed: Stock options exercised
−Removed: Issuance of common stock, net of offering expenses
+Added: Warrants issued in connection with notes payable
+Added: Exercise of stock options
+Added: Cashless exercise of warrants
Balance at December 31, 2023
−Removed: ( 478,016,671
The accompanying notes are an integral part of these consolidated financial statements.
2 unchanged sentences
CONSOLIDATED STATEMENTS OF
−Removed: Years Ended December 31, 2022 and 2021
−Removed: Years Ended December 31,
+Added: Year Ended December 31,
+Added: (In thousands)
CASH FLOWS FROM OPERATING ACTIVITIES:
−Removed: Adjustments to reconcile net loss to net cash used in operating activities:
+Added: Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
Depreciation and amortization
12 unchanged sentences
Other current and non-current liabilities
−Removed: Net cash used in operating activities
−Removed: ( 112,368,982
+Added: Net cash provided by (used in) operating activities
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment
+Added: Acquisition of intangible assets
Net cash used in investing activities
1 unchanged sentence
Principal payments on notes payable
−Removed: ( 100,000,000
Proceeds from issuance of common stock, net of offering expenses
3 unchanged sentences
Payments on finance lease obligations
−Removed: Proceeds from the exercise of stock options
+Added: Net proceeds from the exercise of stock options
+Added: Payment of end of term fee
Payment of deferred financing fees
−Removed: Net cash provided by financing activities
−Removed: Net increase (decrease) in cash and cash equivalents
+Added: Net cash (used in) provided by financing activities
+Added: Net (decrease) increase in cash and cash equivalents
Cash and cash equivalents - beginning of year
4 unchanged sentences
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: DECEMBER 31, 2022 AND 2021
ORGANIZATION AND BUSINESS
1 unchanged sentence
(“ADMA” or the “Company”) is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing
−Removed: and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases.
−Removed: The Company’s targeted patient populations include immune-compromised
−Removed: individuals who suffer from an underlying immune deficiency disorder or who may be immune-suppressed for medical reasons.
+Added: and developing specialty biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases.
+Added: The Company’s targeted patient populations include immune-compromised individuals who
+Added: suffer from an underlying immune deficiency disorder or who may be immune-suppressed for medical reasons.
ADMA operates through its wholly-owned subsidiaries ADMA BioManufacturing, LLC (“ADMA BioManufacturing”) and ADMA BioCenters Georgia Inc.
(“ADMA BioCenters”).
−Removed: ADMA BioManufacturing was formed in January 2017 to facilitate the acquisition of the Biotest Therapy Business Unit (“BTBU”) from BPC Plasma, Inc.
−Removed: (formerly Biotest Pharmaceuticals Corporation) (“BPC” and, together with
−Removed: Biotest AG, “Biotest”) on June 6, 2017.
−Removed: The acquisition included certain assets (the “Biotest Assets”) of BTBU, which included the U.S.
−Removed: Food and Drug Administration (“FDA”)-licensed BIVIGAM and Nabi-HB immunoglobulin products, and an FDA-licensed
−Removed: plasma fractionation manufacturing facility located in Boca Raton, FL (the “Boca Facility”) (the “Biotest Transaction”).
−Removed: BTBU had previously been the Company’s third-party contract manufacturer.
−Removed: ADMA BioCenters is the Company’s source plasma
−Removed: collection business with ten plasma collection facilities located throughout the U.S., eight of which hold an approved license with the FDA.
+Added: ADMA BioManufacturing was formed in January 2017 to facilitate the acquisition of certain assets held by the Company’s former third-party contract manufacturer, which included the U.S.
+Added: Food and Drug Administration
+Added: (“FDA”)-licensed BIVIGAM and Nabi-HB immunoglobulin products, and an FDA-licensed plasma fractionation manufacturing facility located in Boca Raton, FL (the “Boca Facility”).
+Added: ADMA BioCenters is the Company’s source plasma collection business with
+Added: ten plasma collection facilities located throughout the U.S., all of which hold an approved license with the FDA.
The Company has three
FDA-approved products, all of which are currently marketed and commercially available:
−Removed: (i) BIVIGAM (Immune Globulin Intravenous, Human), an Intravenous Immune Globulin (“IVIG”) product indicated for the treatment of Primary Humoral
−Removed: Immunodeficiency (“PI”), also known as Primary Immunodeficiency Disease (“PIDD”) or Inborn Errors of Immunity, and for which the Company received FDA approval on May 9, 2019 and commenced commercial sales in August 2019;
−Removed: (ii) ASCENIV (Immune
−Removed: Globulin Intravenous, Human – slra 10% Liquid), an IVIG product indicated for the treatment of PI, for which the Company received FDA approval on April 1, 2019 and commenced first commercial sales in October 2019;
−Removed: and (iii) Nabi-HB (Hepatitis B
−Removed: Immune Globulin, Human), which is indicated for the treatment of acute exposure to blood containing Hepatitis B surface antigen (“HBsAg”) and other listed exposures to Hepatitis B.
−Removed: In addition to its commercially available immunoglobulin
−Removed: products, the Company provides contract manufacturing and laboratory services for certain clients and generates revenues from the sale of intermediate by-products that result from the immunoglobulin production process.
−Removed: The Company seeks to
−Removed: develop a pipeline of plasma-derived therapeutics, and its products and product candidates are intended to be used by physician specialists focused on caring for immune-compromised patients with or at risk for certain infectious diseases.
−Removed: As of December 31, 2022, the Company had working capital of $ 231.1 million, including $ 86.5 million of cash and cash equivalents.
−Removed: upon the Company’s current projected revenue and expenditures, including capital expenditures and continued implementation of the Company’s commercialization and expansion activities, the Company’s management currently believes that its cash,
−Removed: cash equivalents, projected revenue and accounts receivable will be sufficient to fund ADMA’s operations, as currently conducted, through the end of the first quarter of 2024, at which time the Company believes it will begin to generate positive
−Removed: cash flow from operations.
−Removed: These estimates may change based upon several factors, including the success of the Company’s commercial sales of its products, whether or not the assumptions underlying the Company’s projected revenues and expenses are
−Removed: correct and the acceptability of ADMA’s immune globulin products by physicians, patients or payers.
−Removed: There can be no assurance that the Company’s approved products will be commercially viable, or that plant capacity expansion, plasma center
−Removed: buildouts or other capital improvements will be successfully completed or that any product developed in the future will be approved.
−Removed: The Company is subject to risks common to companies in the biotechnology and pharmaceutical manufacturing
−Removed: industries including, but not limited to, dependence on collaborative arrangements, development by the Company or its competitors of new technological innovations, dependence on key personnel, inflationary pressures, supply chain constraints,
−Removed: protection of proprietary technology, and compliance with FDA and other governmental regulations and approval requirements.
−Removed: ADMA BIOLOGICS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: DECEMBER 31, 2022 AND 2021
−Removed: The Company continues to evaluate a variety of strategic alternatives through its ongoing engagement with Morgan Stanley.
−Removed: The exploration
−Removed: of value-creating opportunities remains a top corporate priority for ADMA.
−Removed: On December 9, 2022, the Company issued 24,125,873
−Removed: shares of its common stock through an underwritten public offering and received net proceeds of $ 64.6 million, and on March 23, 2022
−Removed: the Company received approximately $ 47.0 million in net proceeds from the refinancing of its senior credit facility (see Note 7).
+Added: (i) ASCENIV (Immune Globulin Intravenous, Human – slra 10% Liquid), an intravenous immune globulin (“IVIG”) product indicated for the treatment of Primary Humoral Immunodeficiency (“PI”), also known as Primary
+Added: Immunodeficiency Disease (“PIDD”) or Inborn Errors of Immunity, for which the Company received FDA approval on April 1, 2019 and commenced first commercial sales in October 2019;
+Added: (ii) BIVIGAM (Immune Globulin Intravenous, Human), an IVIG
+Added: product indicated for the treatment of PI, and for which the Company received FDA approval on May 9, 2019 and commenced commercial sales in August 2019;
+Added: and (iii) Nabi-HB (Hepatitis B Immune Globulin, Human), which is indicated for the
+Added: treatment of acute exposure to blood containing Hepatitis B surface antigen (“HBsAg”) and other listed exposures to Hepatitis B.
+Added: In addition to its commercially available immunoglobulin products, the Company generates revenues from the sale of
+Added: intermediate by-products that result from the immunoglobulin production process and from time to time provides contract manufacturing and laboratory services for certain clients.
+Added: The Company seeks to develop a pipeline of plasma-derived
+Added: therapeutics, and its products and product candidates are intended to be used by physician specialists focused on caring for immune-compromised patients with or at risk for certain infectious diseases .
+Added: As of December 31, 2023, the Company had working capital of $ 207.2 million, including $ 51.4 million of cash and cash equivalents, accounts receivable of $ 27.4 million and $ 172.9 million of
+Added: inventories, partially offset by $ 49.8 million of current liabilities.
+Added: Based upon the Company’s current projected revenue and
+Added: expenditures, including capital expenditures and continued implementation of the Company’s commercialization and expansion activities, the Company’s management currently believes that its cash, cash equivalents and accounts receivable, along
+Added: with its projected future operating cash flow, will be sufficient to fund ADMA’s operations, as currently conducted, through the end of the first quarter of 2025.
+Added: However, the Company’s current outlook on cash flows and profitability may change
+Added: based upon several factors, including the success of the Company’s commercial sales of its products, whether or not the assumptions underlying the Company’s projected revenues and expenses are correct and the continued acceptability of ADMA’s
+Added: immune globulin products by physicians, patients or payers.
+Added: The Company is subject to risks common to companies in the biotechnology and pharmaceutical manufacturing industries including, but not limited to, dependence on collaborative
+Added: arrangements, development by the Company or its competitors of new technological innovations, dependence on key personnel, inflationary pressures, supply chain constraints, protection of proprietary technology, and compliance with FDA and other
+Added: governmental regulations and approval requirements .
SIGNIFICANT ACCOUNTING POLICIES
13 unchanged sentences
Actual results could differ from those estimates.
−Removed: Significant estimates include rebates and chargebacks deducted from gross revenues, the realizable value of accounts receivable, valuation of inventory, assumptions used in projecting future liquidity and capital requirements, assumptions used in
−Removed: the fair value of awards granted under the Company’s equity incentive plans and warrants issued in connection with the issuance of notes payable and the valuation allowance for the Company’s deferred tax assets.
+Added: Significant estimates include rebates and chargebacks deducted from gross revenues, valuation of inventory, assumptions used in projecting future liquidity and capital requirements, assumptions used in the fair value of awards granted under the
+Added: Company’s equity incentive plans and warrants issued in connection with the issuance of notes payable and the valuation allowance for the Company’s deferred tax assets.
Cash and cash equivalents
8 unchanged sentences
Accounts receivable
−Removed: Accounts receivable is reported at realizable value, net of allowances for contractual credits and doubtful accounts in the amount of $ 0.1 million and $ 0.2 million at
−Removed: December 31, 2022 and 2021, respectively, which are recognized in the period the related revenue is recorded.
−Removed: The Company extends credit to its customers based upon an evaluation of each customer’s financial
−Removed: condition and credit history.
−Removed: Evaluations of the financial condition and associated credit risk of customers are performed on an ongoing basis.
−Removed: Based on these evaluations, the Company has concluded that its credit risk is minimal (see
−Removed: Raw materials inventory consists of various materials purchased from suppliers, including normal source plasma, used in the production of
−Removed: the Company’s products.
−Removed: Work-in-process and finished goods inventories (see Note 3) reflect the cost of raw materials as well as costs for direct and indirect labor, primarily salaries, wages and benefits for applicable employees, as well as an
−Removed: allocation of overhead costs related to the Boca Facility including utilities, property taxes, general repairs and maintenance, consumable supplies and depreciation.
−Removed: The allocation of Boca Facility overhead to inventory is generally based upon
−Removed: the estimated square footage of the Boca Facility that is used in the production of the Company’s products relative to the total square footage of the facility.
−Removed: ADMA BIOLOGICS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: DECEMBER 31, 2022 AND 2021
+Added: Accounts receivable is reported at realizable value, net of allowances for contractual credits and doubtful accounts in the amount of $ 0.1 million at December 31, 2023 and 2022, which are recognized in the period the related revenue is recorded.
+Added: The Company extends credit to its customers based upon an evaluation of each customer’s financial condition and credit history.
+Added: Evaluations of the financial condition and associated credit risk of customers are performed on an ongoing
+Added: Based on these evaluations, the Company has concluded that its credit risk is minimal (see Note 16).
+Added: Raw materials inventory consists of normal source plasma (“NSP”) and Respiratory Syncytial Virus (“RSV”) high titer plasma collected
+Added: at the Company’s plasma collection facilities, along with various materials purchased from suppliers, used in the production of the Company’s products.
+Added: Work-in-process and finished goods inventories (see Note 3) reflect the
+Added: cost of raw materials as well as costs for direct and indirect labor, primarily salaries, wages and benefits for applicable employees, as well as an allocation of overhead costs related to the Boca Facility including utilities, property taxes,
+Added: general repairs and maintenance, consumable supplies and depreciation.
+Added: The allocation of Boca Facility overhead to inventory is generally based upon the estimated square footage of the Boca Facility that is used in the production of the Company’s
+Added: products relative to the total square footage of the facility.
Inventories, including plasma intended for resale and plasma intended for internal use in the Company’s manufacturing, commercialization
7 unchanged sentences
In addition, costs
−Removed: associated with the production of conformance or engineering lots that would not qualify as immediately available for commercial sale are charged to cost of product revenue and not capitalized into inventory.
+Added: associated with the production of engineering lots that would not qualify as immediately available for commercial sale are charged to cost of product revenue and not capitalized into inventory.
Property and equipment
24 unchanged sentences
Any resulting impairment is recorded as a reduction in the carrying value of the related asset in excess of fair value and a charge to operating results.
−Removed: For the years ended December 31, 2022 and
−Removed: 2021, the Company determined that there was no impairment of its long-lived assets.
+Added: For the years ended December 31, 2023,
+Added: 2022 and 2021, the Company determined that there was no impairment of its long-lived assets.
Revenue recognition
Revenues for the years ended December 31, 2023, 2022 and 2021 are comprised of (i) revenues from the sale of the Company’s immunoglobulin
−Removed: products, BIVIGAM, ASCENIV and Nabi-HB, (ii) product revenues from the sale of human plasma collected by the Company’s Plasma Collection Centers business segment, (iii) contract manufacturing and laboratory services revenue, (iv) revenues from
−Removed: the sale of intermediate by-products;
−Removed: and (v) license and other revenues primarily attributable to the out-licensing of ASCENIV to Biotest in 2012 to market and sell this product in Europe and selected countries in North Africa and the Middle
−Removed: Biotest has provided the Company with certain services and financial payments in accordance with the related Biotest license agreement and is obligated to pay the Company certain amounts in the future if certain milestones are achieved.
+Added: products, ASCENIV, BIVIGAM and Nabi-HB, (ii) product revenues from the sale of human plasma collected by the Company’s Plasma Collection Centers business segment, (iii) contract manufacturing and laboratory services revenue, (iv) revenues from
+Added: the sale of intermediate by-products and (v) license and other revenues primarily attributable to the out-licensing of ASCENIV to Biotest, AG (“Biotest”) in 2012 to market and sell this product in Europe and selected countries in North Africa and
+Added: the Middle East.
+Added: Biotest has provided the Company with certain services and financial payments in accordance with the related Biotest license agreement and is obligated to pay the Company certain amounts in the future if certain milestones are
Deferred revenue is amortized into income over the term of the Biotest license, representing a period of approximately 22 years .
−Removed: ADMA BIOLOGICS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: DECEMBER 31, 2022 AND 2021
Product revenue is recognized when the customer is deemed to have control over the product.
3 unchanged sentences
Revenue from the sale of the Company’s immunoglobulin products is
−Removed: recognized when the product reaches the customer’s destination, and is recorded net of estimated rebates, price protection arrangements and customer incentives, including prompt pay discounts, wholesaler chargebacks and other wholesaler fees.
−Removed: These estimates are based on contractual arrangements, historical experience and certain other assumptions, and the Company believes that such estimates are reasonable.
−Removed: For revenues associated with contract manufacturing and the sale of
−Removed: intermediates, control transfers to the customer and the performance obligation is satisfied when the customer takes possession of the product from the Boca Facility or from a third-party warehouse that is utilized by the Company.
+Added: recognized when the product reaches the customer’s destination, and is recorded net of estimated rebates, wholesaler distribution and related fees, customer incentives, including prompt pay discounts, wholesaler chargebacks, group purchasing organization fees and reimbursements for patient assistance.
+Added: estimates are based on contractual arrangements, historical experience and certain other assumptions, and while the Company believes that such estimates are reasonable, they are subject to change based on future developments and other factors.
+Added: For revenues associated with contract manufacturing and the sale of intermediates, control transfers to the customer and the performance obligation is satisfied when the customer takes possession of the product from the Boca Facility or from a
+Added: third-party warehouse that is utilized by the Company .
Product revenues from the sale of human plasma collected at the Company’s plasma collection centers are recognized at the time control of
8 unchanged sentences
Research and development expenses consist of clinical research organization costs, costs related to clinical trials, post-marketing
−Removed: commitment studies for BIVIGAM and ASCENIV, wages, benefits and stock-based compensation for employees directly related to research and development activities.
+Added: commitment studies for BIVIGAM and ASCENIV and salaries, benefits and stock-based compensation for employees directly related to research and development activities.
All research and development costs are expensed as incurred.
1 unchanged sentence
Plasma center operating expenses consist of certain general and administrative plasma center costs, initial opening, marketing and
−Removed: start-up costs, rent expense, maintenance, utilities, compensation and benefits for center and administrative staff, advertising and promotion expenses and computer software fees related to donor collections.
+Added: start-up costs, rent expense, maintenance, utilities and compensation and benefits for administrative staff.
Advertising and marketing expenses
Advertising and marketing expense includes cost for promotional materials and trade show expenses for the marketing of the Company’s
−Removed: products and services and expenses incurred for attracting donors to the Company’s plasma collection centers.
+Added: products and expenses incurred for attracting donors to the Company’s plasma collection centers.
All advertising and marketing expenses are expensed as incurred.
−Removed: Advertising and marketing expenses were $ 2.2 million and $ 1.4 million for the
−Removed: years ended December 31, 2022 and 2021, respectively.
+Added: Advertising and marketing expenses were $ 3.3 million, $ 2.2 million and $ 1.4 million for the years ended December 31, 2023, 2022 and 2021, respectively.
Stock-based compensation
−Removed: The Company follows recognized accounting guidance which requires all equity-based payments, including grants of stock options, to be
−Removed: recognized in the statement of operations as compensation expense based on their fair values at the date of grant.
−Removed: Compensation expense related to awards to employees and directors with service-based vesting conditions is recognized on a
−Removed: straight-line basis over the associated vesting period of the award based on the grant date fair value of the award.
−Removed: Stock options granted under the Company’s equity incentive plans generally have a four-year vesting period and a term of 10 years .
−Removed: milestone-based equity awards (see Note 8) the Company periodically assesses the probability of vesting for each milestone-based award and adjusts compensation expense based on its probability assessment.
+Added: The Company follows recognized accounting guidance which requires all equity-based payments, including grants of stock options and
+Added: restricted stock unit awards (“RSUs”), to be recognized in the statement of operations as compensation expense based on their fair values at the date of grant.
+Added: Compensation expense related to awards to employees and directors with service-based
+Added: vesting conditions is recognized on a straight-line basis over the associated vesting period of the award based on the grant date fair value of the award.
+Added: Stock options granted to employees under the Company’s equity incentive plans generally
+Added: have a four-year vesting period and a term of 10 years .
+Added: RSUs granted to employees also have a four-year vesting period.
+Added: For milestone-based equity
+Added: awards (see Note 8) the Company periodically assesses the probability of vesting for each milestone-based award and adjusts compensation expense based on its probability assessment.
Pursuant to ASU No.
−Removed: 2016-09, Improvements to Employee Share-Based Payment Accounting (Topic 718) , the Company has elected not to establish a forfeiture rate, as stock-based compensation expense related to forfeitures of unvested equity
−Removed: awards is fully reversed at the time of forfeiture.
−Removed: ADMA BIOLOGICS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: DECEMBER 31, 2022 AND 2021
+Added: 2016-09, Improvements
+Added: to Employee Share-Based Payment Accounting (Topic 718) , the Company has elected not to establish a forfeiture rate, as stock-based compensation expense related to forfeitures of unvested equity awards is fully reversed at the time of
The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in
25 unchanged sentences
Recent Accounting Pronouncements
+Added: In November of 2023 the FASB issued ASU No.
+Added: 2023-07, Segment Reporting (Topic 280):
+Added: Improvements to
+Added: Reportable Segment Disclosures.
+Added: The amendments in this Update are intended to provide financial statement users with more disaggregated expense information about a public entity’s reportable segments, however the Update does not change the
+Added: definition of a business segment or the method for determining reportable segments.
+Added: This update becomes effective for fiscal years beginning after December 15, 2023.
+Added: The Company does not expect this update to have a material impact on its
+Added: consolidated financial statements.
+Added: In December of 2023 the FASB issued ASU 2023-09, Income Taxes (Topic 740):
+Added: Improvements to Income Tax Disclosures.
+Added: This Update requires disaggregated
+Added: information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid and becomes effective for public business entities for fiscal years beginning after December 15, 2024.
+Added: The Company has yet to
+Added: determine the impact this Update may have on the Company’s consolidated financial statements.
There were no new accounting
pronouncements adopted during the years ended December 31, 2023, 2022 and 2021 that had a significant impact on the Company’s consolidated financial statements.
−Removed: ADMA BIOLOGICS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: DECEMBER 31, 2022 AND 2021
The following table provides the components of inventories:
+Added: (In thousands)
Raw materials
2 unchanged sentences
Total inventories
−Removed: Raw materials includes plasma and other materials expected to be used in the production of BIVIGAM, ASCENIV and Nabi-HB.
+Added: Raw materials includes plasma and other materials expected to be used in the production of ASCENIV, BIVIGAM and Nabi-HB.
These materials
−Removed: will be consumed in the production of goods expected to be available for sale or otherwise have alternative uses that provide a probable future benefit.
+Added: will be consumed in the production of products expected to be available for sale or otherwise have alternative uses that provide a probable future benefit.
All other activities and materials associated with the production of inventories used in
research and development activities are expensed as incurred.
−Removed: Work-in-process inventory primarily consists of bulk drug substance and unlabeled filled vials of the Company’s immunoglobulin products.
−Removed: Finished goods inventory is comprised of immunoglobulin product inventory and related intermediates that are available for commercial
−Removed: sale, as well as plasma collected at the Company’s plasma collection centers which is expected to be sold to third-party customers.
+Added: Work-in-process inventory primarily consists of the Company’s IVIG products that are manufactured to the bulk drug substance and unlabeled filled vials stage of
+Added: Finished goods inventory is comprised of the Company’s immunoglobulin products that have reached the filled, labeled and serialized vial stage of production and related
+Added: intermediates that are available for commercial sale, as well as plasma collected at the Company’s plasma collection centers which is expected to be sold to third-party customers .
PROPERTY AND EQUIPMENT
2 unchanged sentences
December 31, 2022
+Added: (In thousands)
Manufacturing and laboratory equipment
6 unchanged sentences
Total property, plant and equipment, net
−Removed: The Company recorded depreciation expense on property and equipment of $ 6.4 million and $ 4.8 million for the years ended December 31,
−Removed: 2022 and 2021, respectively.
+Added: The Company recorded depreciation expense on property and equipment of $ 7.6 million, $ 6.4 million and $ 4.8 million for the years ended December 31, 2023, 2022 and 2021, respectively.
INTANGIBLE ASSETS
2 unchanged sentences
December 31, 2022
−Removed: Accumulated Amortization
−Removed: Accumulated Amortization
+Added: (In thousands)
Trademark and other intangible rights related to Nabi-HB
+Added: Internally developed software
Rights to intermediates
−Removed: ADMA BIOLOGICS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: DECEMBER 31, 2022 AND 2021
−Removed: Under the previous contract manufacturing agreement between ADMA and BPC, intermediate by-products derived from
−Removed: the manufacture of ASCENIV were property of Biotest.
−Removed: As a result of the Biotest Transaction, ADMA obtained the right to these intermediate products, which are being amortized over a period of seven years .
+Added: Under the previous contract manufacturing agreement between ADMA and Biotest, intermediate by-products derived
+Added: from the manufacture of ASCENIV were property of Biotest.
+Added: As a result of the acquisition of certain assets from Biotest on June 6, 2017, ADMA obtained the right to these intermediate products, which are being amortized over a period of seven years .
The intangible rights to Nabi-HB are also being amortized over a period of seven years .
−Removed: Amortization expense related to the Company’s intangible assets for the years ended December 31, 2022 and 2021 was
−Removed: $ 0.7 million.
−Removed: Estimated aggregate future aggregate amortization expense is expected to be as follows:
+Added: During the year ended December 31, 2023, the Company implemented an internally developed data intelligence and analytics program at a cost of approximately $ 0.2 million which is being amortized over a period of four years .
+Added: Amortization expense related to the Company’s intangible assets for the years ended December 31, 2023, 2022 and
+Added: 2021 was $ 0.7 million.
+Added: Estimated aggregate future aggregate amortization expense is expected to be as follows (in thousands):
ACCRUED EXPENSES AND OTHER LIABILITIES
2 unchanged sentences
December 31, 2022
+Added: (In thousands)
Accrued rebates
9 unchanged sentences
December 31, 2022
−Removed: Notes payable
+Added: (In thousands)
+Added: Revolving credit facility
Debt discount
Senior notes payable
−Removed: On March 23, 2022 (the “Hayfin Closing Date”), the Company and all of its subsidiaries entered into a Credit and Guaranty Agreement (the “Hayfin
−Removed: Credit Agreement”) with Hayfin Services LLP (“Hayfin”).
−Removed: The Hayfin Credit Agreement provides for a senior secured term loan facility in a principal amount of up to $ 175.0 million (the “ Hayfin Credit Facility ”), composed of (i) a term loan made on the Hayfin Closing Date in the principal amount of $ 150.0 million ( the “Hayfin Closing Date Loan”), and (ii) a delayed draw term loan in the principal
−Removed: amount of $ 25.0 million (the “ Hayfin Delayed Draw Loan ” and, together with the Hayfin Closing Date Loan, the “Hayfin Loans ”).
−Removed: The obligation of the lenders to make the Hayfin Delayed Draw Loan was to expire on March 22, 2023
−Removed: (see Note 17) and is subject to the satisfaction of certain conditions, including, but not limited to, the Company’s meeting certain 12-month revenue targets as set forth in the Hayfin Credit Agreement, which the Company has met.
−Removed: Credit Facility has a maturity date of March 23, 2027 (the “Hayfin Maturity Date”), subject to acceleration pursuant to the Hayfin
−Removed: Credit Agreement, including upon an Event of Default (as defined in the Hayfin Credit Agreement).
−Removed: ADMA BIOLOGICS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: DECEMBER 31, 2022 AND 2021
+Added: On December 18, 2023 (the “Ares Closing Date”), the Company
+Added: and all of its subsidiaries entered into a new senior secured credit facility (the “Ares Credit Agreement”) with Ares Capital Corporation and certain credit funds affiliated with Ares Capital Corporation (collectively, “Ares”).
+Added: The Ares Credit
+Added: Agreement provides for a total of $ 135.0 million in senior secured credit facilities (the “Ares Credit Facility”) consisting of (i) a
+Added: term loan in the aggregate principal amount of $ 62.5 million and (ii) a revolving credit facility in the aggregate principal amount
+Added: of $ 72.5 million (collectively, the “Ares Loans”), both of which were fully drawn on the Ares Closing Date.
+Added: The Ares Credit Facility
+Added: has a maturity date of December 20, 2027 (the “Ares Maturity Date”).
+Added: On the Ares Closing Date, the Company used the proceeds from
+Added: the Ares Loans, along with a portion of its existing cash on hand, to terminate and pay in full all of the outstanding obligations under the Company’s previous senior credit facility (the “Hayfin Credit Facility”) with Hayfin Services LLP
+Added: (“Hayfin”) including the outstanding principal in the amount of $ 158.6 million, a prepayment penalty in the amount $ 11.1 million, an exit fee of $ 1.6
+Added: million, all accrued and unpaid interest outstanding on the Hayfin Credit Facility as of the Ares Closing date, as well as certain fees and expenses related thereto.
+Added: In connection with the payoff and termination of the Hayfin Credit Facility,
+Added: the Company also wrote off $ 15.0 million of unamortized debt discount related to the Hayfin Credit Facility.
+Added: As a result of this
+Added: transaction, the Company recorded a loss on the extinguishment of the Hayfin Credit Facility in the amount of $ 26.2 million, which is
+Added: mainly comprised of the write-off of unamortized debt discount and the prepayment penalty.
+Added: Borrowings under the term loan initially bear interest at the
+Added: adjusted Term SOFR for a three-month tenor in effect on the day that is two business days prior to the first day of the applicable calendar quarter plus 6.50 %
+Added: (the “Initial SOFR Term Loan Applicable Margin”).
+Added: Borrowings under the revolving facility initially bear interest at the adjusted Term SOFR for a three-month
+Added: tenor in effect on the day that is two business days prior to the first day of the applicable calendar quarter plus 3.75 % (the “SOFR Revolving Facility Applicable Margin”).
+Added: On the Ares Closing Date, the interest rate on the term loan was 11.87774 % and the interest rate on the revolving facility was 9.12774 %.
+Added: On the Ares Maturity Date, the Company is required to pay Ares the entire outstanding principal amount underlying the Ares Loans and any accrued
+Added: and unpaid interest thereon.
+Added: Prior to the Ares Maturity Date, there are no scheduled principal payments on the Ares Credit
+Added: Facilities, and the Company is required to make quarterly interest payments to Ares of approximately $ 3.7 million.
+Added: The Company may prepay the outstanding principal under the revolving facility, together with any accrued but unpaid interest on the
+Added: prepaid principal amount, at any time and from time to time upon three business days’ prior written notice with no prepayment premium.
+Added: However, in the event the Company prepays an amount under the Revolving Facility that is greater than 50 % of the current $ 72.5 million
+Added: outstanding balance, the Company will still be required to pay interest on 50 % of this balance, or $ 36.3 million, through the term of Ares Credit Facility.
+Added: The Company may prepay the outstanding principal on the term loan, together with any accrued
+Added: but unpaid interest on the prepaid principal amount, at any time and from time to time upon three business days’ prior written
+Added: notice, subject to the payment to Ares of a prepayment premium equal to (i) the present value as of such date of all remaining required interest payments on the principal amount being repaid plus 1.5 % of the prepaid principal amount, if prepaid on or prior to the first anniversary of the Ares Closing Date, (ii) 1.5 % of the prepaid principal amount, if prepaid after the first anniversary of the Ares Closing Date and on or prior to the second anniversary of the Ares Closing
+Added: Date, or (iii) 1.0 % of the prepaid principal amount, if prepaid on or prior to the third anniversary of the Ares Closing Date.
+Added: In connection with the closing of the Ares Credit Facility, the Company incurred fees and expenses related to the transaction of $ 2.8 million, including a $ 1.7 million
+Added: original discount payable to Ares, all of which was deducted from the Ares loan proceeds.
+Added: In addition, the Company is also required to pay Ares an exit fee of $ 1.7 million upon the earlier of any prepayment date or the Ares Maturity Date, and this amount has been accrued as a separate liability in the Company’s consolidated balance sheet as of
+Added: December 31, 2023.
+Added: As a result, the Company recognized an aggregate debt discount of $ 4.4 million as of the Ares Closing Date, and
+Added: the weighted-average effective interest rate on the Ares Loans as of December 31, 2023 was 11.39 %.
+Added: This debt discount was recorded
+Added: as a reduction to the face amount of the debt and is being amortized as interest expense over the term of the debt using the interest method.
+Added: All of the Company’s obligations under the Ares Credit Agreement are secured by a first-priority lien and security interest in substantially all
+Added: of the Company’s tangible and intangible assets, including intellectual property and all of the equity interests in the Company’s subsidiaries.
+Added: The Ares Credit Agreement contains certain representations and warranties, affirmative covenants,
+Added: negative covenants and conditions that are customarily required for similar debt financings.
+Added: The negative covenants include certain financial covenants, including maximum total leverage ratios and a $ 15,000,000 minimum liquidity covenant, and also restrict or limit the Company’s ability and the ability of the Company’s subsidiaries to, among other things and subject
+Added: to certain exceptions contained in the Ares Credit Agreement, incur new indebtedness;
+Added: create liens on assets;
+Added: engage in certain fundamental corporate changes, such as mergers or acquisitions, or changes to the Company’s or the Company’s
+Added: subsidiaries’ business activities;
+Added: make certain Investments or Restricted Payments (each as defined in the Ares Credit Agreement);
+Added: engage in certain affiliate transactions;
+Added: or enter into, amend or terminate any other agreements that have the
+Added: impact of restricting the Company’s ability to make loan repayments under the Ares Credit Agreement.
+Added: As of December 31, 2023 the Company was in compliance with all of the covenants contained in the Ares Credit Agreement.
+Added: Events of Default on the Ares Loans include, among others, non-payment of principal, interest or fees, violation of covenants, inaccuracy of
+Added: representations and warranties, bankruptcy and insolvency events, material judgments, cross-defaults to material contracts and events constituting a change of control.
+Added: If there is an event of default, the Company will incur an increase in the
+Added: rate of interest on the Ares Loans of 2 % per annum.
+Added: On March 23, 2022 (the “Hayfin Closing Date”), the Company and all of its subsidiaries entered into the Hayfin Credit Agreement with Hayfin.
+Added: Hayfin Credit Agreement provided for a senior secured term loan facility in a principal amount of up to $ 175.0 million (the “ Hayfin Credit Facility ”), composed of (i) a term loan made on the Hayfin Closing Date in the principal amount of
+Added: $ 150.0 million ( the “Hayfin Closing Date Loan”), and (ii) a delayed draw term loan in the principal amount of $ 25.0 million (the “ Hayfin Delayed Draw Loan ” and, together with the Hayfin Closing
+Added: Date Loan, the “Hayfin Loans ”).
+Added: The Hayfin Delayed Draw Loan was not
+Added: drawn prior to the Ares Closing Date.
+Added: The Hayfin Credit Facility had a maturity date of March 23, 2027 (the “Hayfin Maturity Date”),
+Added: subject to acceleration pursuant to the Hayfin Credit Agreement, including upon an Event of Default (as defined in the Hayfin Credit Agreement).
Hayfin Closing Date, the Company used $ 100.0 million of the Hayfin Closing Date Loan to terminate and pay in full all of the outstanding
1 unchanged sentence
The Company also used $ 2.0 million of the Hayfin Closing Date Loan proceeds to pay a redemption premium to Perceptive and used approximately $ 1.0 million of the Hayfin Closing Date Loan proceeds to pay certain fees and expenses incurred in connection with this transaction.
−Removed: In addition, a $ 1.8 million upfront fee payable to Hayfin was paid “in kind” and was added to the outstanding principal balance in accordance with the terms of the
−Removed: Hayfin Credit Agreement.
−Removed: In connection with the retirement of the Perceptive Credit Facility and all of the obligations thereunder, the Company recorded a loss on extinguishment of debt in the amount of $ 6.7 million, consisting of the write-off of unamortized discount related to the Perceptive indebtedness and the redemption premium paid to Perceptive.
+Added: In addition, a $ 1.8 million upfront fee payable to Hayfin was paid “in kind” and was added to the outstanding principal balance in accordance with the terms of the Hayfin Credit Agreement.
+Added: connection with the retirement of the Perceptive Credit Facility and all of the obligations thereunder, the Company recorded a loss on extinguishment of debt in the amount of $ 6.7 million, consisting of the write-off of unamortized discount related to the Perceptive indebtedness and the redemption premium paid to Perceptive.
Borrowings under the Hayfin
−Removed: Credit Agreement bear interest, at the Company’s election, at either (a) a base rate (equal to the highest of (i) the rate of interest per annum last quoted by The Wall Street Journal as the “Prime Rate” in the United States, (ii) the federal
−Removed: funds rate in effect on such day plus 0.50 % and (iii) adjusted Term Secured Overnight Financing Rate (“SOFR”) for a one-month tenor in effect on such day plus 1.00 %),
−Removed: plus an applicable margin of 8.5 %, or (b) adjusted Term SOFR for either a one-month or three-month tenor, as elected by the Company, and subject to a floor of 1.25 %, plus an applicable margin of 9.5 % (the “Applicable
−Removed: provided, however, that upon, and during the continuance of, an Event of Default, the Applicable Margin shall increase by an additional 3 %
−Removed: On the last day of each calendar month or quarter during the term of the Hayfin Credit Facility, the Company will pay accrued interest to Hayfin.
−Removed: The rate of interest in effect as of the Hayfin Closing Date and as of December 31,
−Removed: 2022 was 10.75 % and approximately 13.9 %,
−Removed: respectively.
−Removed: The Company is also permitted to pay “in kind” a portion of the interest on the Hayfin Loans for each monthly or quarterly interest period in an amount equal to 2.5 % per annum, which is added to the principal amount of the outstanding debt under the Hayfin Credit Facility.
−Removed: From the Hayfin Closing Date through December 31, 2022,
−Removed: approximately $ 3.0 million of interest was paid in kind and added to the balance of the outstanding Hayfin Loans.
−Removed: On the Hayfin Maturity Date, the
−Removed: Company will pay Hayfin the entire outstanding principal amount underlying the Hayfin Loans and any accrued and unpaid interest thereon, as well as an exit fee of 1.0 % of the outstanding principal amount being paid.
−Removed: This exit fee is recorded separately as a non-current liability on the accompanying consolidated balance sheet as of December 31, 2022.
−Removed: Prior to the Hayfin
−Removed: Maturity Date, there are no scheduled principal payments on the Hayfin Loans.
−Removed: The Company may prepay outstanding principal on the
−Removed: Hayfin Loans at any time and from time to time upon five business days’ prior written notice, subject to the payment to Hayfin of,
−Removed: (A) any accrued but unpaid interest on the prepaid principal amount plus (B) an early prepayment fee in the amount equal to (i) 7.0 %
−Removed: of the prepaid principal amount, if prepaid on or prior to the first anniversary of the Hayfin Closing Date, (ii) 3.0 % of the
−Removed: prepaid principal amount, if prepaid after the first anniversary of the Hayfin Closing Date and on or prior to the second anniversary of the Hayfin Closing Date, or (iii) 1.0 % of the prepaid principal amount, if prepaid after the second anniversary of the Hayfin Closing Date and on or prior to the third anniversary of the Hayfin Closing
−Removed: In addition, for any prepayments of principal or payment of principal on the Hayfin Maturity Date, the Company is also required to pay the exit fee.
−Removed: All of the Company’s obligations under the Hayfin Credit Agreement are secured by a first-priority lien and security interest in substantially all of the Company’s tangible and intangible assets, including intellectual property, and all of the
−Removed: equity interests in the Company’s subsidiaries.
−Removed: Credit Agreement contains certain representations and warranties, affirmative covenants, negative covenants and conditions that are customarily required for similar financings.
−Removed: The negative covenants restrict or limit the ability of the Company
−Removed: and its subsidiaries to, among other things and subject to certain exceptions contained in the Hayfin Credit Agreement, incur new indebtedness;
+Added: Credit Agreement bore interest, at the Company’s election, at the adjusted Term SOFR for a one-month tenor, subject to a floor of 1.25 %, plus an applicable margin of 9.5 %
+Added: (the “Applicable Margin”);
+Added: provided, however, that upon, and during the continuance of, an Event of Default, the Applicable Margin would increase by an additional 3 % per annum.
+Added: On May 1, 2023 the Hayfin Credit Agreement was amended to reduce the Applicable Margin from 9.5 % to 8.5 %.
+Added: On the last day of each calendar month prior to the Ares
+Added: Closing Date, the Company paid accrued interest to Hayfin.
+Added: The rate of interest in effect as of the Hayfin Closing Date, December 31, 2022 and the Ares Closing Date was 10.75 %, approximately 13.7 % and approximately 13.9 %, respectively.
+Added: The Company was also permitted to pay “in kind” a portion of the interest on the Hayfin Loans for each monthly interest period
+Added: in an amount equal to 2.5 % per annum, which was added to the principal amount of the outstanding debt under the Hayfin Credit
+Added: From the Hayfin Closing Date through December 31, 2022, $ 3.0 million of interest was paid in kind and added to the balance
+Added: of the outstanding Hayfin Loans.
+Added: For the year ended December 31, 2023, $ 3.8 million of interest was paid in kind and added to the
+Added: balance of the outstanding Hayfin Loans.
+Added: On the Ares Closing Date, the Company
+Added: paid Hayfin the entire outstanding principal amount underlying the Hayfin Loans and all accrued and unpaid interest thereon, as well as the exit fee of 1.0 % of the outstanding principal amount paid.
+Added: This exit fee had been recorded separately as a non-current liability on the accompanying consolidated balance sheet as of December 31,
+Added: In accordance with the terms of the Hayfin Credit Agreement, the Company also paid Hayfin the early prepayment fee in the amount equal 7.0 %
+Added: of the prepaid principal amount of $ 158.6 million, or $ 11.1 million.
+Added: All of the Company’s obligations under the Hayfin Credit Agreement were secured by a first-priority lien and security interest in substantially all of the Company’s tangible and intangible assets,
+Added: including intellectual property, and all of the equity interests in the Company’s subsidiaries.
+Added: The Hayfin Credit Agreement contained certain representations and warranties, affirmative covenants, negative covenants and conditions that are
+Added: customarily required for similar debt financings.
+Added: The negative covenants restricted or limited the ability of the Company and its subsidiaries to, among other things and subject to certain exceptions contained in the Hayfin Credit Agreement,
+Added: incur new indebtedness;
create liens on assets;
−Removed: engage in certain fundamental corporate changes, such as mergers or acquisitions, or changes to the Company’s or its
−Removed: subsidiaries’ business activities;
−Removed: make certain Investments or Restricted Payments (each as defined in the Hayfin Credit Agreement);
+Added: engage in certain fundamental corporate changes, such as mergers or acquisitions, or changes to the Company’s or its subsidiaries’ business activities;
+Added: make certain Investments or Restricted
+Added: Payments (each as defined in the Hayfin Credit Agreement);
change its fiscal year;
2 unchanged sentences
engage in certain affiliate transactions;
−Removed: or enter into, amend or terminate any
−Removed: other agreements that have the impact of restricting the Company’s ability to make loan repayments under the Hayfin Credit Agreement.
−Removed: In addition, the Company is required (i) at all times prior to the Maturity Date to maintain a minimum cash balance of $ 6.0 million;
+Added: or enter into, amend or terminate any other agreements that have the
+Added: impact of restricting the Company’s ability to make loan repayments under the Hayfin Credit Agreement.
+Added: In addition, the Company was required (i) at all times prior to the Hayfin Maturity Date to maintain a minimum cash balance of $ 6.0 million;
and (ii) as of the last day of each fiscal quarter, report IVIG product and related revenues for the trailing 12-month period that exceed
the amounts set forth in the Hayfin Credit Agreement,
−Removed: which range from $ 75.0 million for the fiscal quarter ended June 30, 2022 to $ 250.0 million for the fiscal quarter ended December 31, 2026.
−Removed: As of December 31, 2022, the Company was in compliance with all of the covenants contained in the Hayfin Credit Agreement.
+Added: which ranged from $ 75.0 million for the fiscal quarter ended June 30, 2022 to $ 110.0 million for the fiscal quarter ended September 30, 2023.
+Added: As of the Ares Closing Date and December 31, 2022, the Company was in compliance with all of the covenants contained in the
+Added: Hayfin Credit Agreement.
As consideration for the Hayfin
−Removed: Credit Agreement, the Company issued to various entities affiliated with Hayfin, on the Hayfin Closing Date, warrants to purchase an aggregate of 9,103,047
+Added: Credit Agreement, on the Hayfin Closing Date the Company issued to various entities affiliated with Hayfin warrants to purchase an aggregate of 9,103,047
shares of the Company’s common stock (the “Hayfin Warrants”).
3 unchanged sentences
The Hayfin Warrants were valued by the Company at approximately $ 9.6 million as of the Hayfin Closing
−Removed: Date and have an expiration date of March 23, 2029 .
−Removed: ADMA BIOLOGICS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: DECEMBER 31, 2022 AND 2021
−Removed: As a result of the upfront fee and exit fee paid or payable to Hayfin, the expenses incurred by the Company in connection with this transaction and the value of the Hayfin Warrants, the Company recognized an aggregate discount on the
−Removed: Hayfin Loans in the amount of $ 13.9 million.
−Removed: The Company records debt discount as a reduction to the face amount of the debt, and
−Removed: the debt discount is amortized as interest expense over the life of the debt using the interest method.
−Removed: Based on the fair value of the Hayfin Warrants and the aggregate amount of fees and expenses associated with obtaining the Hayfin Credit
−Removed: Facility, the effective interest rate on the Hayfin Loans as of the Hayfin Closing Date and as of December 31, 2022 was approximately 13.0 %
−Removed: and 16.1 %, respectively.
+Added: Date and have an expiration date of March 23, 2029 (see Note 8).
+Added: As consideration for the foregoing amendment to the Hayfin Credit
+Added: Agreement on May 1, 2023, the Company issued additional warrants to the lenders to purchase 2,391,244 shares of the Company’s common
+Added: stock at an exercise price of $ 3.2619 per share (the “Hayfin Second Amendment Warrants”).
+Added: The Hayfin Second Amendment Warrants were
+Added: valued at approximately $ 5.6 million and have an expiration date of May 1, 2030 .
+Added: As a result of the upfront fee and exit fee paid or payable to Hayfin, the expenses incurred by the Company in connection with this transaction and
+Added: the value of the Hayfin Warrants and Hayfin Second Amendment Warrants, the Company recognized a discount on the Hayfin Loans in the amount of $ 13.9
+Added: million for the year ended December 31, 2022 and an additional debt discount in the year ended December 31, 2023 in the amount of $ 5.7
+Added: The Company records debt discount as a reduction to the face amount of the debt, and the debt discount is amortized as interest expense over the life of the debt using the interest method.
+Added: As of the Ares Closing Date, $ 15.0 million of the aggregate debt discount associated with the Hayfin Credit Facility was unamortized, and this amount is reflected in the loss on
+Added: extinguishment of debt for the year ended December 31, 2023.
+Added: Based on the fair value of the Hayfin Warrants and the aggregate amount of fees and expenses associated with obtaining the Hayfin Credit Facility, the effective interest rate on the
+Added: Hayfin Loans as of the Hayfin Closing Date and as of December 31, 2022 was approximately 13.0 % and 16.1 %, respectively .
STOCKHOLDERS ’ EQUITY
12 unchanged sentences
Net proceeds after underwriting discounts and expenses associated with the offering were approximately $ 64.6
−Removed: million and are being used to accelerate commercialization and production activities, complete plasma center buildouts and obtain FDA approvals, to conclude post‑FDA marketing approval research and development projects, and for working capital,
+Added: million and were used to accelerate commercialization and production activities, complete plasma center buildouts and obtain FDA approvals, to conclude post‑FDA marketing approval research and development projects, and for working capital,
capital expenditures and general corporate purposes.
9 unchanged sentences
compliance, to explore business development opportunities and for general corporate purposes and other capital expenditures.
−Removed: ADMA BIOLOGICS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: DECEMBER 31, 2022 AND 2021
September 3, 2021, the Company entered into a distribution agreement with Raymond James & Associates, Inc., as agent (“Agent”), pursuant to which the Company may offer and sell, from time to time, at its option, through or to the Agent,
2 unchanged sentences
intends to use any net proceeds from the sale of its common stock under the Distribution Agreement for general corporate purposes, including procurement of source plasma and other raw materials, supply chain initiatives and production
−Removed: expenditures, funding expansion of plasma centers, working capital, capital expenditures, expansion and resources for commercialization activities, and other potential research and development and business opportunities.
−Removed: T he Company currently has approximately $ 42.8
−Removed: million of shares available to sell under the Distribution Agreement.
+Added: expenditures, working capital, capital expenditures, expansion and resources for commercialization activities, and other potential research and development and business opportunities.
+Added: T he Company currently has approximately $ 42.8 million of shares
+Added: available to sell under the Distribution Agreement.
There were no sales under the Distribution Agreement during the year ended December 31, 2022 .
7 unchanged sentences
Company issued and sold 27,805,198 shares of common stock under the 2020 Sale Agreement and received net proceeds of $ 60.4 million.
+Added: On June 16, 2023, various entities affiliated with Hayfin exercised 3,388,686 Hayfin Warrants in a cashless exercise transaction resulting in the Company issuing 1,967,847 shares of its common stock to such entities.
+Added: On May 1, 2023 the Company issued the Hayfin Second Amendment Warrants (see Note 7), which were valued at $ 5.6 million using the Black-Scholes option-pricing model assuming an expected term of seven years , a volatility of 67.8 %, a dividend yield
+Added: of 0 % and a risk-free rate of interest of 3.62 %.
On March 23, 2022, the Company issued the Hayfin Warrants, whereby affiliates
−Removed: of Hayfin may purchase an aggregate of 9,103,047 shares of common stock at an exercise price $ 1.6478 per share (see Note 7).
−Removed: The Hayfin Warrants was valued at $ 9.6 million, using the Black-Scholes option pricing model assuming an expected term of 7
+Added: of Hayfin may purchase an aggregate of 9,103,047 shares of common stock at an exercise price of $ 1.6478 per share (see Note 7).
+Added: The Hayfin Warrants were valued at $ 9.6 million, using the Black-Scholes option pricing model assuming an expected term of 7
years, a volatility of 68.1 %, a dividend yield of 0 % and a risk-free interest rate of 2.36 %.
During the year ended December 31, 2022, warrants to
−Removed: purchase 31,750 shares of common stock that had been issued to a former noteholder of the Company expired.
+Added: purchase 106,059 shares of common stock that had been issued to former noteholders of the Company expired.
At December 31,
1 unchanged sentence
dates ranging between May 2023 and December 2030.
+Added: The following table summarizes information about warrants outstanding as of December 31, 2023, 2022 and 2021:
+Added: Exercise Price
+Added: Warrants outstanding at December 31, 2020
+Added: Warrants outstanding at December 31, 2021
+Added: Warrants outstanding at December 31, 2022
+Added: Warrants outstanding at December 31, 2023
Equity Incentive Plans
12 unchanged sentences
In accordance with the foregoing, on January 1, 2022 the aggregate number of shares available for issuance increased to 7,901,643 .
−Removed: ADMA BIOLOGICS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: DECEMBER 31, 2022 AND 2021
During the years
ended December 31, 2022 and 2021, the Company granted options to purchase an aggregate of 1,194,032 and 1,895,550 shares of common stock, respectively, to its directors and employees under the 2014 Plan.
−Removed: The fair value of stock options granted was
−Removed: determined on the date of grant using the Black-Scholes model.
−Removed: The Black-Scholes option pricing model was developed for use in estimating the fair value of publicly traded options, which have no vesting restrictions and are fully
−Removed: transferable.
−Removed: The Company’s employee stock options have characteristics significantly different from those of traded options, and changes in the underlying Black-Scholes assumptions can materially affect the fair value estimate.
−Removed: determine the risk-free interest rate, the Company utilized the U.S.
+Added: On June 21, 2022, the Company’s
+Added: stockholders approved the ADMA Biologics, Inc.
+Added: 2022 Compensation Plan (the “2022 Equity Plan”).
+Added: Approval of the 2022 Equity Plan resulted in approximately 18 million additional shares of the Company’s common stock being reserved for future awards.
+Added: The 2022 Equity Plan provides for the Board or a Committee of the Board (the “Committee”) to grant awards to
+Added: optionees and to determine the exercise price, vesting term, expiration date and all other terms and conditions of the awards, including acceleration of the vesting of an award at any time.
+Added: Any options granted under the 2022 Equity Plan
+Added: are intended to be Incentive Stock Options (“ISOs”), unless specified by the Committee to be Non-Qualified Options (“NQOs”) as defined by the Internal Revenue Code.
+Added: ISOs and NQOs may be granted to employees, consultants or Board members
+Added: at an option price not less than the fair market value of the common stock subject to the stock option agreement.
+Added: For the year ended December 31,
+Added: 2023, the Company granted options to purchase an aggregate of 1,826,380 shares of common stock to employees and directors
+Added: under the 2022 Equity Plan.
+Added: Also during the year ended December 31, 2023, options to purchase 3,814,122 shares of common stock
+Added: were exercised, for which 2,109,722 shares were withheld to cover the aggregate exercise prices and 259,867 shares were withheld to cover payroll taxes, and the Company received aggregate net exercise proceeds of $ 1.1 million.
+Added: The fair value of
+Added: stock options granted was determined on the date of grant using the Black-Scholes model.
+Added: The Black-Scholes option pricing model was developed for use in estimating the fair value of publicly traded options, which have no vesting
+Added: restrictions and are fully transferable.
+Added: The Company’s employee stock options have characteristics significantly different from those of traded options, and changes in the underlying Black-Scholes assumptions can materially affect the fair
+Added: value estimate.
+Added: To determine the risk-free interest rate, the Company utilized the U.S.
Treasury yield curve in effect at the time of the grant with a term consistent with the term of the awards granted by the Company.
−Removed: The expected term of the options granted
−Removed: is in accordance with Staff Accounting Bulletins 107 and 110, which is based on the average between vesting terms and contractual terms.
−Removed: The expected dividend yield reflects the Company’s current and expected future policy for dividends on
−Removed: the Company’s common stock.
−Removed: For the years ended December 31, 2022 and 2021, the expected stock price volatility for the Company’s stock options was calculated by examining the historical volatility of the Company’s common stock since the
−Removed: stock became publicly traded in the fourth quarter of 2013.
−Removed: date fair values of stock options awarded during the years ended December 31, 2022 and 2021 were determined using the Black-Scholes option pricing model with the following assumptions:
+Added: The expected term of
+Added: the options granted is in accordance with Staff Accounting Bulletins 107 and 110, which is based on the average between vesting terms and contractual terms.
+Added: The expected dividend yield reflects the Company’s current and expected future
+Added: policy for dividends on the Company’s common stock.
+Added: For the years ended December 31, 2023, 2022 and 2021, the expected stock price volatility for the Company’s stock options was calculated by examining the historical volatility of the
+Added: Company’s common stock since the stock became publicly traded in the fourth quarter of 2013.
+Added: The grant date fair values of stock options
+Added: awarded during the years ended December 31, 2023, 2022 and 2021 were determined using the Black-Scholes option pricing model with the following assumptions:
Expected term
1 unchanged sentence
5.5 - 6.3 years
+Added: 5.5 - 6.3 years
Dividend yield
Risk-free interest rate
−Removed: On June 21, 2022, the Company’s stockholders approved the ADMA Biologics, Inc.
−Removed: 2022 Compensation Plan (the “2022 Equity Plan”).
−Removed: Approval of the 2022 Equity Plan resulted in approximately 18
−Removed: million additional shares of the Company’s common stock being reserved for future awards.
−Removed: The 2022 Equity Plan provides for the Board or a Committee of the Board (the “Committee”) to grant awards to optionees and to determine the exercise
−Removed: price, vesting term, expiration date and all other terms and conditions of the awards, including acceleration of the vesting of an award at any time.
−Removed: Any options granted under the 2022 Equity Plan are intended to be Incentive Stock Options
−Removed: (“ISOs”), unless specified by the Committee to be Non-Qualified Options (“NQOs”) as defined by the Internal Revenue Code.
−Removed: ISOs and NQOs may be granted to employees, consultants or Board members at an option price not less than the fair market
−Removed: value of the common stock subject to the stock option agreement.
−Removed: The following
−Removed: table summarizes information about stock options outstanding as of December 31, 2022 and 2021:
+Added: The following table
+Added: summarizes information about stock options outstanding as of December 31, 2023, 2022 and 2021:
Exercise Price
2 unchanged sentences
Options outstanding, vested and expected to vest at December 31, 2022
+Added: Options outstanding, vested and expected to vest at December 31, 2023
Options exercisable
−Removed: ADMA BIOLOGICS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: DECEMBER 31, 2022 AND 2021
As of December 31, 2023, the Company had $ 3.8
18 unchanged sentences
$ 10.80 - $ 16.20
−Removed: During the years ended December 31, 2022 and 2021, the Company granted Restricted Stock Units (“RSUs”) representing an
−Removed: aggregate of 1,174,266 and 4,384,744
−Removed: shares, respectively, to certain management employees of the Company and during 2022, to members of the Board.
−Removed: Except for the RSUs granted under the Company’s retention incentive program discussed below, the RSUs generally vest annually over a
−Removed: period of four years for employees and semi-annually over a period of one year for directors.
−Removed: The RSUs granted during the year ended December 31, 2021 include 3,832,500
−Removed: shares granted under a retention incentive program implemented by the Company for its executive management and certain employees (see Note 10), whereby the Company issued an aggregate of 2,685,000 time-based RSUs and 1,147,500 milestone-based RSUs.
−Removed: Fifty percent of the time-based RSUs granted under the retention incentive program vested on December 31, 2022, with the remainder vesting in
−Removed: quarterly installments through December 31, 2024.
−Removed: The milestone-based RSUs vested upon achievement of the applicable milestone, and all of the milestone-based RSUs vested during the
−Removed: year ended December 31, 2022.
−Removed: The milestones required to be achieved in order for the milestone-based RSUs to vest were determined by the Board and were consistent with the 2022 operating plan approved by the Board .
+Added: During the years ended December 31, 2023, 2022 and 2021, the Company granted RSUs representing an aggregate of 3,389,760 , 1,174,266 and 4,384,744 shares, respectively, to certain employees of the Company and to
+Added: members of the Board.
+Added: Except for the RSUs granted under the Company’s retention incentive program discussed below, the RSUs generally vest annually over a period of four years for employees and semi-annually over a period of one year for
+Added: The RSUs granted during the year ended December 31, 2021 include 3,832,500 shares granted under a retention incentive
+Added: program implemented by the Company for its executive management and certain employees (see Note 10), whereby the Company issued an aggregate of 2,685,000
+Added: time-based RSUs and 1,147,500 milestone-based RSUs.
+Added: Fifty percent of the time-based RSUs granted under the retention incentive program vested on December 31, 2022, with the remainder vesting in quarterly installments through December 31,
+Added: The milestone-based RSUs vested upon achievement of the applicable milestone, and all of the milestone-based RSUs vested during the year ended December 31, 2022.
+Added: milestones required to be achieved in order for the milestone-based RSUs to vest were determined by the Board and were consistent with the 2022 operating plan approved by the Board .
During the years ended December 31, 2023, 2022 and 2021, 1,199,445 ,
−Removed: and 92,750 shares, respectively,
−Removed: vested in connection with grants of RSUs.
−Removed: With respect to the RSUs vested during the year ended December 31, 2022, 918,851 shares
−Removed: valued at approximately $ 2.9 million were withheld by the Company to cover employees’ tax liabilities .
−Removed: For the RSUs vested during the year ended December 31, 2021 , 27,850
−Removed: shares valued at approximately $ 62,000 were withheld by the Company to cover employees’ tax liabilities.
−Removed: These shares have been retired by the
−Removed: Company or were otherwise no longer outstanding as of December 31, 2022 .
−Removed: A summary of the Company’s unvested RSU activity and related information is as
+Added: 2,727,412 and 92,750
+Added: shares, respectively, vested in connection with grants of RSUs.
+Added: respect to RSUs vested during the year ended December 31, 2023, 365,722 shares valued at approximately $ 1.3 million were withheld by the Company to cover employees’ tax liabilities.
+Added: With respect to the RSUs vested during the year ended
+Added: December 31, 2022, 918,851 shares valued at approximately $ 2.9 million were withheld by the Company to cover employees’ tax liabilities .
+Added: For the RSUs vested during
+Added: the year ended December 31, 2021 , 27,850 shares valued at approximately $ 62,000 were withheld by the Company to cover employees’ tax liabilities.
+Added: All of these shares have been retired by the Company or were otherwise no longer outstanding as of December 31, 2023 .
+Added: A summary of the Company’s unvested RSU activity and related information is as follows:
Average Grant
3 unchanged sentences
Balance at December 31, 2022
−Removed: ADMA BIOLOGICS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: DECEMBER 31, 2022 AND 2021
+Added: Balance at December 31, 2023
As of December 31, 2023, the Company had $ 10.4 million of unrecognized compensation expense related to unvested RSUs granted
under the Company’s equity incentive plans, which is expected to be recognized over a weighted-average period of 2.9 years.
−Removed: Total stock-based compensation expense for all awards granted under the Company’s equity incentive plans for the years ended December 31, 2022 and 2021 was as follows:
+Added: Total stock-based compensation
+Added: expense for all awards granted under the Company’s equity incentive plans for the years ended December 31, 2023, 2022 and 2021 was as follows (in thousands):
Research and development
15 unchanged sentences
related (common area) expenses, equipment and certain other operational expenses, which were not material to the consolidated financial statements for the years ended December 31, 2023, 2022 and 2021.
−Removed: During the years ended December 31, 2022 and 2021, the Company purchased certain specialized medical equipment and services related to the
−Removed: Company’s plasma collection centers, as well as personal protective equipment, from GenesisBPS and its affiliates (“Genesis”) in the amount of $ 0.2
+Added: During the years ended December 31, 2023, 2022 and 2021, the Company purchased certain specialized medical equipment and services related
+Added: to the Company’s plasma collection centers, as well as personal protective equipment, from GenesisBPS and its affiliates (“Genesis”) in the amount of $ 0.4
+Added: million, $ 0.2 million and $ 0.2
+Added: million, respectively.
Genesis is owned by Dr.
Grossman and Adam Grossman.
+Added: On August 15, 2023, two of the Company’s executive
+Added: officers exercised options to purchase 2,909,721 shares of the Company’s common stock on a cashless basis, and 688,657 shares of common stock were issued to these executive officers, net of 257,867 shares of common stock to cover a portion of their tax liabilities (see Note 8) .
See Note 7 for a discussion of the Company’s prior credit facility and related transactions with Perceptive, a holder of more
−Removed: than 5 % of the Company’s common stock.
+Added: than 5 % of the Company’s common stock during the year ended December 31, 2022.In connection with the 2022 public offering of the
+Added: Company’s common stock (see Note 8) on December 9, 2022:
+Added: Grossman purchased 14,983 shares of common stock directly and 14,982 shares of common stock indirectly through an entity he controls, and (ii) Brian Lenz, the Company’s Executive Vice President and Chief
+Added: Financial Officer, purchased 6,993 shares of common stock, all at the public offering price of $ 2.86 per share.
the year ended December 31, 2021, in connection with the resignation of Dr.
2 unchanged sentences
a period of 10 months.
−Removed: connection with the 2022 public offering of the Company’s common stock (see Note 8) on December 9, 2022:
−Removed: Grossman purchased 14,983
−Removed: shares of common stock directly and 14,982 shares of common stock indirectly through an entity he controls, and (ii) Brian Lenz, the
−Removed: Company’s Executive Vice President and Chief Financial Officer, purchased 6,993 shares of common stock, all at the public offering
−Removed: price of $ 2.86 per share.
In connection with
4 unchanged sentences
Grossman purchased 100,000 shares of common stock, (iii) Dr.
−Removed: Young Kwon, a member of the Board, purchased 100,000 shares of common stock, and (iv) Brian Lenz, the Company’s Executive Vice President and Chief Financial Officer, purchased 30,000 shares of common stock, all at the public offering price of $ 1.00 per
−Removed: ADMA BIOLOGICS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: DECEMBER 31, 2022 AND 2021
+Added: Young Kwon, a member of the Board, purchased 100,000 shares of common stock, and (iv) Brian Lenz, the Company’s Executive Vice President and Chief Financial Officer, purchased 30,000 shares of common stock, all at the public offering price of $ 1.00
COMMITMENTS AND CONTINGENCIES
3 unchanged sentences
Management does not expect that the outcome of any such claims or actions will have a material effect on the Company’s liquidity, results of operations or financial condition.
−Removed: COVID-19 Pandemic
−Removed: The Company continues to monitor the ongoing developments related to the COVID-19 pandemic, including the emergence of the
−Removed: Delta, Omicron and BA.2 variants and other resistant strains of the coronavirus, and its impacts to the Company’s commercial and manufacturing operations and plasma collection facilities, including collections of source plasma, procurement of raw
−Removed: materials and packaging materials, a portion of which are sourced internationally, and the testing of finished drug product that is required prior to its availability for commercial sale.
−Removed: A substantial portion of such testing has historically
−Removed: been performed by contract laboratories outside the United States.
−Removed: Due to a combination of previously mandated state and local “shelter-in-place” orders, as well as government stimulus
−Removed: packages, persisting social distancing measures and varying roll-outs of vaccinations by state, the Company experienced lower than normal donor collections at its FDA approved plasma collection centers during 2021.
−Removed: The Company was also subject
−Removed: to delays in shipments of source plasma from its contracted third-party suppliers, as well as delays in deliveries for personal protective equipment, reagents and other non-plasma raw materials and supplies used in the manufacture and
−Removed: distribution of its products.
−Removed: In addition, the Company is subject to supply chain delays as a result of certain of its suppliers diverting significant resources towards the rapid development and distribution of COVID-19 vaccines and, as a
−Removed: result, the Company has elected to carry more raw materials inventory than it has in the past.
−Removed: The COVID-19 pandemic previously impacted, to a certain degree, the Company’s customer engagement initiatives, whereby ADMA’s sales and medical
−Removed: affairs field personnel faced difficulties communicating directly with physicians and other healthcare professionals, as well as the cancellation or postponement of a number of key scientific and medical meetings, further limiting the Company’s
−Removed: ability to communicate with potential customers.
−Removed: The pandemic could also impact the Company’s ability to interact with the FDA or other regulatory authorities and may result
−Removed: in delays in the conduct of inspections or review of pending applications or submissions.
−Removed: Although the Company received FDA approvals for four
−Removed: of its plasma collection centers during the year ended December 31, 2022 and received several FDA approvals and two FDA inspections
−Removed: of the Boca Facility were completed during the year ended December 31, 2021, no assurances can be provided as to the timing for completion of any future regulatory submissions or applications that may be impacted by restrictions related to
−Removed: During the years ended December 31, 2022 and 2021, revenue attributable to international customers was approximately 5 % and 13 %, respectively, of the
−Removed: Company’s total revenues.
−Removed: As the Company seeks to grow this aspect of its business, it may also be subject to the impacts of the COVID-19 pandemic in locations outside the United States.
−Removed: Notwithstanding the foregoing, the COVID-19 pandemic to date has not had a material impact on the Company’s financial condition or results
−Removed: of operations, and the Company does not believe that its production operations at the Boca Facility, the Company’s contract fill/finishers or its plasma collection facilities have been significantly impacted by the COVID-19 pandemic.
−Removed: the Company does not anticipate and has not experienced any material impairments with respect to any of its long-lived assets, including the Company’s property and equipment, goodwill or intangible assets.
−Removed: Although the COVID-19 pandemic has not, to date, materially adversely impacted the Company’s capital and financial resources, because the
−Removed: Company is unable to determine the ultimate severity or duration of the COVID-19 pandemic or other pandemics or their long-term effects on, among other things, the global, national or local economies, the capital and credit markets or the
−Removed: Company’s workforce, customers or our suppliers, at this time the Company is unable to predict whether COVID-19 or other pandemics will have a material adverse impact on the Company’s business, financial condition, liquidity or results of
−Removed: ADMA BIOLOGICS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: DECEMBER 31, 2022 AND 2021
+Added: IT Systems Disruption
+Added: On June 19, 2023, the Company experienced an IT systems disruption, which rendered certain of the Company’s IT technology
+Added: systems inaccessible for less than one week.
+Added: The Company’s investigation of the disruption has essentially been completed with the
+Added: assistance of third-party consultants, and no definitive root cause was identified.
+Added: At the time of the disruption, the Company was in production of two
+Added: batches of BIVIGAM, and after a prolonged hold time, it was deemed to be a prudent GMP quality decision to discard these two
+Added: in-process production batches as these batches were no longer viable for further production or had any alternative use.
+Added: As a result, the Company recorded a one-time, non-recurring charge of $ 2.1 million in the second quarter of 2023 for this inventory, which is reflected in Cost of product revenue in the accompanying consolidated statements of operations for the
+Added: year ending December 31, 2023.
+Added: In addition, the Company’s Plasma center operating expenses were adversely impacted by approximately $ 0.7
+Added: million due to the temporary closing of the Company’s plasma collection centers while their IT systems were restored.
+Added: The Company carries appropriate insurance for these types of instances, and while there can be no assurances ADMA will be
+Added: reimbursed for the insurance claims made pertaining to these charges, the Company is actively working with its insurance broker and carriers.
Vendor Commitments
−Removed: Pursuant to the terms of a plasma purchase agreement with BPC dated as of November 17, 2011 (the “2011 Plasma Purchase Agreement”), the
−Removed: Company agreed to purchase from BPC an annual minimum volume of source plasma containing antibodies to RSV to be used in the manufacture of ASCENIV.
−Removed: The Company must purchase a to-be-determined and agreed upon annual minimum volume from BPC, but
−Removed: may also collect high-titer RSV plasma from up to five wholly-owned ADMA plasma collection facilities.
−Removed: During 2015, the Company and
−Removed: BPC amended the 2011 Plasma Purchase Agreement to allow the Company the ability to collect its raw material RSV high-titer plasma from other third-party collection organizations, thus allowing the Company to expand its reach for raw material
−Removed: supply as it executes its commercialization plans for ASCENIV.
−Removed: As part of the closing of the Biotest Transaction, the parties amended the 2011 Plasma Purchase Agreement to extend the initial term through the ten-year anniversary of the closing date of the Biotest Transaction.
−Removed: Unless terminated earlier, the 2011 Plasma Purchase Agreement expires in June
−Removed: 2027, after which it may be renewed for two additional five-year periods if agreed to by the parties.
−Removed: On December 10, 2018, BPC assigned its rights and obligations under the 2011 Plasma Purchase Agreement to Grifols Worldwide Operations
−Removed: Limited (“Grifols”) as its successor-in-interest, effective January 1, 2019.
−Removed: On January 1, 2019, Grifols and the Company entered into an additional amendment to the 2011 Plasma Purchase Agreement for the purchase of source plasma containing
−Removed: antibodies to RSV from Grifols.
−Removed: Pursuant to this amendment, until January 1, 2022, the Company could purchase RSV plasma from Grifols from the two
−Removed: plasma collection centers that were transferred to BPC on January 1, 2019 at a price equal to cost plus five percent ( 5 %) (without any additional increase due to inflation).
−Removed: Effective January 1, 2022, RSV
−Removed: plasma purchased from these two plasma collection centers are subject to the pricing terms in effect for RSV plasma purchased from
−Removed: other plasma collection centers owned by Grifols.
−Removed: On June 6, 2017, the Company and BPC entered into a Plasma Supply Agreement pursuant to which BPC supplies, on an exclusive basis subject
−Removed: to certain exceptions, to ADMA BioManufacturing an annual minimum volume of hyperimmune plasma that contain antibodies to the Hepatitis B virus for the manufacture of Nabi-HB.
−Removed: The Plasma Supply Agreement has a 10-year term.
−Removed: On July 19, 2018, the Company and BPC entered into an amendment to the Plasma Supply Agreement to provide, among other things, that in
−Removed: the event BPC elects not to supply in excess of ADMA BioManufacturing’s specified amount of Hepatitis B plasma and ADMA BioManufacturing is unable to secure Hepatitis B plasma from a third party at a price that is within a low double- digit
−Removed: percentage of the price that ADMA BioManufacturing pays to BPC, then BPC shall reimburse ADMA BioManufacturing for the difference in price ADMA BioManufacturing incurs.
−Removed: On December 10, 2018, BPC assigned its rights and obligations under the
−Removed: Plasma Supply Agreement to Grifols, effective January 1, 2019.
−Removed: On June 6, 2017, the Company and BPC entered into a Plasma Purchase Agreement (the “2017 Plasma Purchase Agreement”), pursuant to which
−Removed: ADMA BioManufacturing purchases normal source plasma (“NSP”) from BPC at agreed upon annual quantities and prices.
−Removed: The 2017 Plasma Purchase Agreement has an initial term of five years after which the 2017 Plasma Purchase Agreement may be renewed for additional two
−Removed: terms of two years each upon the mutual written consent of the parties.
−Removed: On July 19, 2018, the Company and BPC entered into an
−Removed: amendment to the 2017 Plasma Purchase Agreement to, among other things, provide agreed upon amounts of normal source plasma to be supplied by BPC to ADMA BioManufacturing in calendar year 2019 at a specified price per liter, provided that ADMA
−Removed: BioManufacturing delivers a valid purchase order to BPC.
−Removed: Additionally, pursuant to the amendment to the 2017 Plasma Purchase Agreement, BPC agreed that, for calendar years 2020 and 2021, it shall supply no less than a high double-digit percentage
−Removed: of ADMA BioManufacturing’s requested NSP amounts, provided that such requested NSP amounts are within an agreed range, at a price per liter to be mutually determined.
−Removed: Furthermore, pursuant to the amendment to the 2017 Plasma Purchase Agreement,
−Removed: in the event BPC fails to supply ADMA BioManufacturing with at least a high double-digit percentage of ADMA BioManufacturing’s requested NSP amounts, BPC shall promptly reimburse ADMA BioManufacturing the difference in price ADMA BioManufacturing
−Removed: incurs due to BPC’s election not to supply NSP to ADMA BioManufacturing in such amounts as requested.
−Removed: On December 10, 2018, BPC assigned its rights and obligations under the Plasma Purchase Agreement to Grifols, effective January 1, 2019.
−Removed: ADMA BIOLOGICS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: DECEMBER 31, 2022 AND 2021
−Removed: Effective as of May 12, 2021, the Company and Grifols
−Removed: amended the foregoing 2017 Plasma Purchase Agreement whereby, among other things, the term of the agreement was extended through December 31, 2022, while certain historical provisions were deleted.
−Removed: The 2017 Plasma Purchase Agreement expired on
−Removed: December 31, 2022 and was not renewed.
−Removed: In order to maintain a reliable supply of raw material plasma thereafter, the Company has executed additional agreements with multiple third-party suppliers of NSP.
−Removed: The Company has also increased its
−Removed: number of planned plasma collection center buildouts such that the Company expects to have ten FDA-approved plasma collection
−Removed: centers in operation by the end of 2023, while also continuing to increase its plasma collection capabilities at its ADMA BioCenters plasma collection centers business segment.
+Added: Pursuant to the terms of a plasma purchase agreement dated as of November 17, 2011 (the “2011 Plasma Purchase Agreement”), the Company
+Added: agreed to purchase from its former contract manufacturer an annual minimum volume of source plasma containing antibodies to RSV to be used in the manufacture of ASCENIV.
+Added: The Company must purchase a to-be-determined and agreed upon annual minimum
+Added: volume from the counterparty, and under the original 2011 Plasma Purchase Agreement the Company was permitted to also collect high-titer RSV plasma from up to five wholly-owned ADMA plasma collection facilities.
+Added: During 2015, the Company amended the 2011 Plasma Purchase Agreement to (i) allow the Company to collect its raw material RSV high-titer plasma from any number
+Added: of wholly-owned ADMA plasma collection facilities and (ii) allow the Company to purchase its raw material RSV high-titer plasma from other third-party collection organizations, in each case, provided that the annual minimum volumes from the
+Added: Company’s former contract manufacturer were met, thus allowing the Company to expand its reach for raw material supply as it executes its commercialization plans for ASCENIV.
+Added: Unless terminated earlier, the 2011 Plasma Purchase Agreement expires
+Added: in June 2027, after which it may be renewed for two additional five-year periods if agreed to by the parties.
+Added: On December 10, 2018, the Company’s former contract manufacturer assigned its rights and obligations under the 2011 Plasma
+Added: Purchase Agreement to Grifols Worldwide Operations Limited (“Grifols”) as its successor-in-interest, effective January 1, 2019.
+Added: On June 6, 2017, the Company entered into a Plasma Supply Agreement with its former contract manufacturer, pursuant to which the
+Added: counterparty supplies, on an exclusive basis subject to certain exceptions, to ADMA BioManufacturing an annual minimum volume of hyperimmune plasma that contain antibodies to the Hepatitis B virus for the manufacture of Nabi-HB.
+Added: The Plasma Supply
+Added: Agreement has a 10-year term.
+Added: On July 19, 2018, the Plasma
+Added: Supply Agreement was amended to provide, among other things, that in the event the counterparty elects not to supply in excess of ADMA BioManufacturing’s specified amount of Hepatitis B plasma and ADMA BioManufacturing is unable to secure
+Added: Hepatitis B plasma from a third party at a price that is within a low double- digit percentage of the price that ADMA BioManufacturing pays to the counterparty, then the counterparty shall reimburse ADMA BioManufacturing for the difference in
+Added: price ADMA BioManufacturing incurs.
+Added: On December 10, 2018, the Company’s former contract manufacturer assigned its rights and obligations under the Plasma Supply Agreement to Grifols, effective January 1, 201 9.
Post-Marketing Commitments
2 unchanged sentences
BIVIGAM-treated patients with primary humoral immunodeficiency.
−Removed: The Pediatric study for BIVIGAM has been completed, and the safety study is still pending completion.
−Removed: ADMA has assumed the remaining obligations, and the costs of the studies will be
−Removed: expensed as incurred as research and development expenses.
−Removed: For the years ended December 31, 2022 and 2021, the Company incurred expenses related to these studies of $ 2.2 million and $ 1.7 million, respectively.
−Removed: The Company currently expects to incur expenses of
−Removed: approximately $ 2.0 million to complete these studies, with both studies anticipated to be completed by June of 2023.
+Added: These studies were required to be completed by June 30, 2023.
+Added: Both studies have been completed and the study reports have been submitted to the FDA.
+Added: ADMA had assumed the remaining
+Added: obligations, and the costs of the studies were expensed as incurred as research and development expenses.
+Added: For the years ended December 31, 2023, 2022 and 2021, the Company incurred expenses related to these studies of $ 1.7 million, $ 2.2 million and $ 1.7 million, respectively.
In connection with the FDA approval of ASCENIV on April 1, 2019, the Company is required to perform a pediatric study to evaluate the
safety and efficacy of ASCENIV in children and adolescents.
−Removed: For the years ended December 31, 2022 and 2021, the Company incurred expenses related to this study in the amount of $ 0.5 million and $ 0.6 million, respectively.
−Removed: The Company expects
−Removed: to incur expenses of approximately $ 1.5 million to complete this study, which is required to be completed by June of 2023.
+Added: For the years ended December 31, 2023, 2022 and 2021, the Company incurred expenses related to this study in the amount of $ 1.0 million, $ 0.5 million and $ 0.6 million, respectively.
+Added: The Company expects to incur expenses of approximately $ 1.5 million to complete this study, which is required to be completed by June of 2026.
Employment Contracts
6 unchanged sentences
Lenz, and to certain other employees.
−Removed: purpose of the retention program was to promote and ensure business continuity and provide an incentive to the Company’s executive management and certain other employees considering the operational challenges presented by the ongoing COVID -19 pandemic and the competitive work environment in which the Company operates as an FDA regulated manufacturer of specialized biologic therapies.
+Added: purpose of the retention program was to promote and ensure business continuity and provide an incentive to the Company’s executive management and certain other employees, considering the operational challenges presented by the COVID -19 pandemic and the competitive work environment in which the Company operates as an FDA regulated manufacturer of specialized biologic therapies.
The retention awards were granted considering the nationwide labor
10 unchanged sentences
Company does not anticipate recognizing any significant losses relating to these arrangements.
−Removed: ADMA BIOLOGICS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: DECEMBER 31, 2022 AND 2021
A reconciliation of income taxes at the U.S.
federal statutory rate to the benefit for income taxes is as follows:
−Removed: Year Ended December 31,
+Added: Years Ended December 31,
+Added: (In thousands)
Benefit at U.S.
17 unchanged sentences
Net deferred tax assets
−Removed: As of December 31, 2022, the Company had federal and state (post-apportioned
−Removed: basis) net operating losses (“NOLs”) of $ 334.5 million and $ 211.7 million, respectively, as well as federal research and development tax credit carryforwards of approximately $ 0.4 million.
−Removed: Approximately $ 55.2 million and $ 91.8 million of the foregoing federal and state NOLs, respectively, will expire at various dates from 2027 through 2042 , if not limited by triggering events prior
−Removed: to such time.
−Removed: Under the provisions of the Internal Revenue Code, changes in ownership of the Company, in certain circumstances, would limit the amount of federal NOLs that can be utilized annually in the future to offset taxable income.
−Removed: In particular, Section 382 of the Internal Revenue Code (“Section 382”) imposes limitations on an entity’s ability to use NOLs upon certain changes in ownership.
−Removed: If the Company is limited in its ability to use its NOLs in future years in which it
−Removed: has taxable income, then the Company will pay more taxes than if it were otherwise able to fully utilize its NOLs.
−Removed: The Company may experience ownership changes in the future as a result of subsequent shifts in ownership of the Company’s capital
−Removed: stock that the Company cannot predict or control that could result in further limitations being placed on the Company’s ability to utilize its federal NOLs.
−Removed: As of December 31, 2022, the Company performed a preliminary analysis of limitations
−Removed: imposed by Section 382 and determined that no ownership changes occurred in the current year which would cause additional limitations on the use of the NOLs.
−Removed: As of December 31, 2021, the Company performed an analysis of limitations imposed
−Removed: by Section 382 and as a result the Company wrote off the deferred tax assets related to $ 3.0 million of federal NOLs, $ 1.0 million of federal research and development tax credits and $ 28.1 million of state NOLs which were limited by historical ownership changes.
−Removed: As a result, there was a $ 3.9 million reduction to the Company’s net deferred tax assets, which was offset by a corresponding $ 3.9 million reduction in the Company’s valuation allowance, resulting in no net impact to the Company’s provision for income taxes for the year ended December 31, 2021.
+Added: As of December 31, 2023, the Company had federal and state (post-apportioned basis) net operating losses (“NOLs”) of $ 315.6 million and $ 216.4 million, respectively, as well as
+Added: federal research and development tax credit carryforwards of approximately $ 0.1 million.
+Added: Approximately $ 35.6 million and $ 95.1 million of the
+Added: foregoing Federal and state NOLs, respectively, will expire at various dates from 2028 through 2043 , if not limited by triggering events prior to such time.
+Added: Under the provisions of the Internal Revenue Code, changes in ownership of the
+Added: Company, in certain circumstances, would limit the amount of federal NOLs that can be utilized annually in the future to offset taxable income.
+Added: In particular, Section 382 of the Internal Revenue Code (“Section 382”) imposes limitations on an
+Added: entity’s ability to use NOLs upon certain changes in ownership.
+Added: If the Company is limited in its ability to use its NOLs in future years in which it has taxable income, then the Company will pay more taxes than if it were otherwise able to fully
+Added: utilize its NOLs.
+Added: The Company may experience ownership changes in the future as a result of subsequent shifts in ownership of the Company’s capital stock that the Company cannot predict or control that could result in further limitations being
+Added: placed on the Company’s ability to utilize its Federal NOLs.
+Added: As of December 31, 2023, the Company performed a substantive analysis of limitations imposed by Section 382 on historical information and concluded that no ownership changes occurred as
+Added: of December 31, 2023 and 2022.
+Added: As part of the substantive analysis, the Company did determine that an additional $ 14.2 million of state
+Added: NOLs were not subject to limitation of prior ownership changes and are therefore available to offset future taxable income.
A valuation allowance, if needed, reduces deferred tax assets to the amount expected to be realized.
8 unchanged sentences
Based on these criteria and the relative weighting of both the positive and negative evidence available, management continues to maintain a full valuation allowance against its net deferred tax assets.
−Removed: ADMA BIOLOGICS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: DECEMBER 31, 2022 AND 2021
In accordance with U.S.
2 unchanged sentences
The tax benefit to be recognized is measured as the largest amount
−Removed: of benefit that is greater than fifty percent likely of being realized upon ultimate settlement.
+Added: of benefit that is greater than 50% likely of being realized upon ultimate settlement.
Derecognition of a tax benefit previously recognized could result in the Company recording a tax liability that would reduce net assets.
−Removed: of the liability for which an exposure exists is measured as the largest amount of benefit determined on a cumulative probability basis that the Company believes is more likely than not to be realized upon ultimate settlement of the position.
−Removed: Components of the liability are classified as either a current or a long-term liability in the accompanying consolidated balance sheets based on when the Company expects each of the items to be settled.
+Added: The amount of the
+Added: liability for which an exposure exists is measured as the largest amount of benefit determined on a cumulative probability basis that the Company believes is more likely than not to be realized upon ultimate settlement of the position.
+Added: of the liability are classified as either a current or a long-term liability in the accompanying consolidated balance sheets based on when the Company expects each of the items to be settled.
The Company does no t have any unrecognized tax benefits as of December 31, 2023 and 2022 and does not anticipate a significant change in unrecognized tax benefits
6 unchanged sentences
The Company determines if an arrangement is an operating lease at inception.
−Removed: Leases with an initial term of 12 months or less are not recorded on the balance sheet.
−Removed: other leases are recorded on the balance sheet with assets representing the right to use the underlying asset for the lease term and lease liabilities representing the obligation to make lease payments arising from the lease.
−Removed: assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term and include options to extend or terminate the lease when they are reasonably certain to be exercised.
+Added: Leases with an initial term of 12 months or less are not recorded on the balance sheet and
+Added: lease expense for such leases are recognized on a straight-line basis over the lease term.
+Added: All other leases are recorded on the balance sheet with assets representing the right to use the underlying asset for the lease term and lease
+Added: liabilities representing the obligation to make lease payments arising from the lease.
+Added: Right-to-use assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term and
+Added: include options to extend or terminate the lease when they are reasonably certain to be exercised.
The present value of the lease payments is determined using the Company’s incremental borrowing rate as of the lease commencement date.
−Removed: For the lease liabilities recognized during the years ended December 31, 2022 and 2021, the Company used
−Removed: discount rates of 13 % to 14 %
−Removed: to determine the present value of its lease obligations.
−Removed: The Company’s operating lease expense is recognized on a straight-line basis over the lease term and is reflected in Plasma center operating expenses and Selling, general and
−Removed: administrative expenses in the accompanying consolidated statements of operations.
−Removed: Aggregate lease expense for the Company’s operating leases for the years ended December 31, 2022 and 2021 was $ 2.1 million and $ 1.4 million, respectively.
−Removed: Aggregate cash
−Removed: paid on these leases for the years ended December 31, 2022 and 2021 was $ 1.8 million and $ 1.4 million, respectively.
−Removed: ADMA BIOLOGICS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: DECEMBER 31, 2022 AND 2021
−Removed: During the year ended December
−Removed: 31, 2022, the Company recognized additional right-to-use assets and corresponding lease liabilities aggregating to approximately $ 4.0
−Removed: million in connection with two new property leases where the Company has opened additional plasma collection facilities, a
−Removed: property lease for the storage of raw materials inventory and a property lease for the building that the Company utilizes as its corporate headquarters (see Note 9).
−Removed: During the year ended December 31, 2021, the Company recognized additional
−Removed: right-to-use assets and corresponding lease liabilities of $ 3.6 million in connection with four new property leases where the Company has opened additional plasma collection facilities.
−Removed: Including a finance lease the Company entered into
−Removed: in June 2018, the Company has aggregate lease liabilities of $ 11.6 million and $ 8.1 million as of December 31, 2022 and 2021, respectively, which are comprised primarily of the leases for the Company’s plasma collection centers.
−Removed: Company’s operating leases have a weighted average remaining term of 8.4 years.
−Removed: Scheduled payments under the Company’s lease
−Removed: obligations are as follows:
+Added: lease liabilities recognized during the years ended December 31, 2023 and 2022, the Company used discount rates of 13 % to 16 % to determine the present value of its lease obligations.
+Added: The Company’s operating lease expense is recognized on a straight-line basis over the
+Added: lease term and is reflected in Plasma center operating expenses and Selling, general and administrative expenses in the accompanying consolidated statements of operations.
+Added: Aggregate lease expense for the Company’s operating leases for the years
+Added: ended December 31, 2023, 2022 and 2021 was $ 2.4 million, $ 2.1 million and $ 1.4 million , respectively.
+Added: Aggregate cash paid on these leases for the
+Added: years ended December 31, 2023, 2022 and 2021 was $ 2.4 million, $ 1.8 million and $ 1.4 million, respectively.
+Added: During the year ended December 31, 2023, the Company recognized one additional right-to-use
+Added: asset and corresponding lease liability in the amount of $ 0.1 million for office equipment leased for the Boca Facility.
+Added: During the year ended December 31, 2022, the Company recognized additional right-to-use assets and corresponding lease liabilities aggregating to approximately $ 4.0 million in connection with two new property leases where the Company
+Added: has opened additional plasma collection facilities, a property lease for the storage of raw materials inventory and a property lease for the building that the Company utilizes as its corporate headquarters (see Note 9).
+Added: Including a finance
+Added: lease the Company entered into in June 2018, the Company has aggregate lease liabilities of $ 10.8 million and $ 11.6 million as of December 31, 2023 and 2022, respectively, which are comprised primarily of the leases for the Company’s plasma collection
+Added: The Company’s operating leases have a weighted average remaining term of 7.6 years.
+Added: Scheduled payments
+Added: under the Company’s lease obligations are as follows (in thousands) :
Year ended December 31, 2024
3 unchanged sentences
Balance at December 31, 2023
−Removed: One of the Company’s operating leases, pertaining to the administrative offices for its Plasma Collection Centers business segment, is scheduled to expire in November
−Removed: The current monthly payment for this lease is approximately $ 10,000 .
−Removed: The Company intends to renew the lease for an additional
−Removed: five years in accordance with the terms of the lease, however no renewal agreement has been finalized.
−Removed: The Company is engaged in manufacturing, marketing and developing specialty plasma-derived biologics.
−Removed: The Company’s ADMA BioManufacturing
−Removed: segment reflects the Company’s immune globulin manufacturing and development operations in Florida, acquired on June 6, 2017.
−Removed: The Plasma Collection Centers segment consists of ten plasma collection facilities as of December 31, 2022, nine of which were
−Removed: operational and collecting plasma, and seven of which hold an approved license with the FDA (and of which three facilities have received approvals from the Korean Ministry of Food and Drug Safety as well as FDA approval to implement a Hepatitis B
+Added: The Company is dedicated to manufacturing, marketing and developing specialty plasma-derived biologics.
+Added: The Company’s ADMA
+Added: BioManufacturing segment reflects the Company’s immune globulin manufacturing and development operations in Florida, acquired on June 6, 2017.
+Added: The Plasma Collection Centers segment consists of ten plasma collection facilities as of December 31, 2023, all of which were operational,collecting plasma, and hold an approved license with the FDA (and of which three facilities have received approvals from the Korean Ministry of Food and Drug Safety as well as FDA approval to implement a Hepatitis B
immunization program).
4 unchanged sentences
Summarized financial information concerning reportable segments is shown in the following tables:
−Removed: ADMA BIOLOGICS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: DECEMBER 31, 2022 AND 2021
Year Ended December 31, 2023
+Added: (in thousands)
BioManufacturing
8 unchanged sentences
Year Ended December 31, 2022
+Added: (in thousands)
BioManufacturing
1 unchanged sentence
Cost of product revenue
+Added: Income (loss) from operations
+Added: Interest and other expense, net
+Added: Loss on extinguishment of debt
+Added: Net income (loss)
+Added: Capital expenditures
+Added: Depreciation and amortization expense
+Added: Year Ended December 31, 2021
+Added: (in thousands)
+Added: BioManufacturing
+Added: Plasma Collection
+Added: Cost of product revenue
Loss from operations
5 unchanged sentences
Under the plan, employees may make contributions which are eligible for a Company
−Removed: discretionary percentage contribution as defined in the plan and determined by the Board of Directors.
−Removed: The Company recognized $ 1.3
−Removed: million and $ 1.1 million of related compensation expense for the years ended December 31, 2022 and 2021, respectively.
−Removed: ADMA BIOLOGICS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: DECEMBER 31, 2022 AND 2021
+Added: discretionary percentage contribution as defined in the plan and determined by the Board.
+Added: The Company recognized $ 1.3 million, $ 1.3 million and $ 1.1 million of related
+Added: compensation expense for the years ended December 31, 2023, 2022 and 2021, respectively.
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION
Supplemental cash flow information for the years ended December 31, 2023, 2022 and 2021 is as follows:
+Added: (In thousands)
SUPPLEMENTAL CASH FLOW INFORMATION:
7 unchanged sentences
accounts receivable.
−Removed: At December 31, 2022, two customers accounted for approximately 92 % of the Company’s consolidated accounts receivable.
−Removed: At December 31, 2021, three
+Added: At December 31, 2023, five customers accounted for approximately 98 % of the Company’s consolidated accounts receivable.
+Added: At December 31, 2022, two
customers accounted for approximately 92 % of the Company’s consolidated accounts receivable.
−Removed: For the year ended December 31, 2022, two
−Removed: customers accounted for approximately 74 % of the Company’s consolidated revenues.
−Removed: For the year ended December 31, 2021, four customers accounted for approximately 81 % of the Company’s consolidated revenues.
+Added: For the year ended December 31, 2023, two customers accounted
+Added: for approximately 72 % of the Company’s consolidated revenues.
+Added: For the year ended December 31, 2022, two customers accounted for approximately 74 %
+Added: of the Company’s consolidated revenues.
+Added: For the year ended December 31, 2021, four customers accounted
+Added: for approximately 81 % of the Company’s consolidated revenues.
During the years ended December 31, 2023 and 2022, plasma purchases from Grifols totaled approximately $ 9.5 million and $ 47.7 million,
2 unchanged sentences
area, based on the location of where the product is shipped, is as follows:
−Removed: Year Ended December 31,
+Added: Years Ended December 31,
+Added: (in thousands)
United States
1 unchanged sentence
Total revenues
−Removed: SUBSEQUENT EVENTS
−Removed: On March 22, 2023, the Company and Hayfin entered into an amendment to the Hayfin Credit Agreement whereby the lenders’ obligation to
−Removed: make the Hayfin Delayed Draw Loan (see Note 7) was extended to June 30, 2023.
+Added: Schedule II – Valuation and Qualifying Accounts
+Added: Years ended December 31, 2023, 2022 and 2021
+Added: (in thousands)
+Added: beginning of year
+Added: Charged to costs
+Added: Year ended December 31, 2023
+Added: Accrued rebates
+Added: Inventory valuation allowance
+Added: Deferred tax asset valuation allowance
+Added: Year ended December 31, 2022
+Added: Accrued rebates
+Added: Inventory valuation allowance
+Added: Deferred tax asset valuation allowance
+Added: Year ended December 31, 2021
+Added: Accrued rebates
+Added: Inventory valuation allowance
+Added: Deferred tax asset valuation allowance
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.