8 unchanged sentences
financial officers, as appropriate to allow timely decisions regarding required disclosure.
−Removed: Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their
−Removed: 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, 2021, our Chief
−Removed: 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: Management recognizes that any set of controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of
+Added: achieving their 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, 2022,
+Added: 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.
Management’s Annual Report on Internal Control Over Financial Reporting
70 unchanged sentences
(2) Financial Statement Schedules.
−Removed: Required information is included in the footnotes to the financial
+Added: Required information is included in the footnotes to the financial statements.
(3) Index to Exhibits.
INDEX TO EXHIBITS
−Removed: Master Purchase and Sale Agreement, dated as of January 21, 2017, by and among Biotest Pharmaceuticals Corporation, ADMA BioManufacturing,
−Removed: LLC, ADMA Biologics, Inc., Biotest AG and Biotest US Corporation (incorporated herein by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K, filed with the SEC on January 23, 2017).
−Removed: Second Amended and Restated Certificate of Incorporation of the Company (incorporated herein by reference to Exhibit 3.1 to the Company’s
−Removed: 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
−Removed: (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on May 28, 2021).
−Removed: 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
−Removed: on October 7, 2016).
+Added: 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
+Added: reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K, filed with the SEC on January 23, 2017).
+Added: 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).
+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
+Added: May 28, 2021).
+Added: 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).
Certificate of Designation of Series A Junior Participating Preferred Stock of ADMA Biologics, Inc.
−Removed: (incorporated by reference to
−Removed: Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the SEC on December 21, 2021).
+Added: (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the SEC on December 21, 2021).
Specimen Common Stock Certificate (incorporated herein by reference to Exhibit 4.1 to Amendment No.
−Removed: 1 to the Company’s Current Report on
−Removed: Form 8-K/A, filed with the SEC on March 29, 2012).
+Added: 1 to the Company’s Current Report on Form 8-K/A, filed with the SEC on March 29, 2012).
Warrant Agreement, dated December 21, 2012, issued by the Company to Hercules Technology Growth Capital, Inc.
−Removed: (incorporated herein by
−Removed: reference to Exhibit 4.3 to the Company’s Registration Statement on Form S-1, filed with the SEC on February 11, 2013).
−Removed: Form of Warrant Agreement, dated May 13, 2016, issued by the Company to Oxford Finance LLC (incorporated herein by reference to Exhibit 4.6
−Removed: to the Company’s Quarterly Report on Form 10-Q, filed with the SEC on May 13, 2016).
+Added: (incorporated herein by reference to Exhibit 4.3 to the Company’s Registration Statement on Form S-1, filed with the SEC on
+Added: February 11, 2013).
+Added: 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).
Warrant to Purchase Stock, dated October 10, 2017, issued by the Company to Marathon Healthcare Finance Fund, L.P.
−Removed: (incorporated herein by
−Removed: reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K, filed with the SEC on October 11, 2017).
−Removed: Warrant to Purchase Stock, dated February 11, 2019, issued by the Company to Perceptive Credit Holdings II, LP (incorporated herein by
−Removed: reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K, filed with the SEC on February 12, 2019).
−Removed: Warrant to Purchase Stock, dated May 3, 2019, issued by the Company to Perceptive Credit Holdings II, LP (incorporated by reference to
−Removed: Exhibit 4.2 to the Company’s Current Report on Form 8-K filed with the SEC on May 3, 2019).
−Removed: Warrant to Purchase Stock, dated December 8, 2020, issued by the Company to Perceptive Credit Holdings II, LP (incorporated by reference to
−Removed: Exhibit 4.7 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, 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
−Removed: 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
−Removed: Company’s Current Report on Form 8-K, filed with the SEC on May 3, 2019 ).
+Added: (incorporated herein by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K, filed with the SEC on
+Added: October 11, 2017).
+Added: Warrant to Purchase Stock, dated February 11, 2019, issued by the Company to Perceptive Credit Holdings II, LP (incorporated herein by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K, filed with the SEC on February
+Added: Warrant to Purchase Stock, dated May 3, 2019, issued by the Company to Perceptive Credit Holdings II, LP (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed with the SEC on May 3, 2019).
+Added: Warrant to Purchase Stock, dated December 8, 2020, issued by the Company to Perceptive Credit Holdings II, LP (incorporated by reference to Exhibit 4.7 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2020,
+Added: filed with the SEC on March 24, 2021).
+Added: 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).
+Added: 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).
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
−Removed: Company’s Current Report on Form 8-K filed with the SEC on December 9, 2020).
−Removed: Description of Securities Registered under Section 12 of the Securities Exchange Act of 1934.
−Removed: Rights Agreement, dated as of December 20, 2021, by and between ADMA Biologics, Inc.
−Removed: and Continental Stock Transfer and Trust Company,
−Removed: as rights agent (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on December 21, 2021).
−Removed: Form of Warrant to
−Removed: Purchase Stock, in the form issued by the Company to various entities affiliated with Hayfin Services LLP, dated as of March 23, 2022
+Added: (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).
+Added: 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).
+Added: 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
+Added: 10-K, filed with the SEC on March 24, 2022).
2007 Employee Stock Option Plan, as amended by Amendment No.
−Removed: 3 (incorporated herein by reference to Exhibit A to the Information
−Removed: Statement on Schedule 14C, filed with the SEC on October 29, 2012).
+Added: 3 (incorporated herein by reference to Exhibit A to the Information Statement on Schedule 14C, filed with the SEC on October 29, 2012).
Amended and Restated ADMA Biologics, Inc.
−Removed: 2014 Omnibus Incentive Compensation Plan (incorporated herein by reference to Exhibit 10.1 to the
−Removed: Company’s Registration Statement on Form S-8, filed with the SEC on August 18, 2017).
+Added: 2014 Omnibus Incentive Compensation Plan (incorporated herein by reference to Exhibit 10.1 to the Company’s Registration Statement on Form S-8, filed with the SEC on August 18, 2017).
Amended and Restated Employment Agreement, dated January 29, 2019, by and between ADMA Biologics, Inc.
−Removed: and Adam Grossman (incorporated
−Removed: herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed with the SEC 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
+Added: on January 29, 2019).
Amendment to Employment Agreement, dated as of September 29, 2021, by and between ADMA Biologics, Inc.
−Removed: and Adam Grossman (incorporated
−Removed: by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K, filed with the SEC on October 1, 2021).
+Added: and Adam Grossman (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K, filed with the SEC on
+Added: October 1, 2021).
Amended and Restated Employment Agreement, dated January 29, 2019, by and between ADMA Biologics, Inc.
−Removed: and Brian Lenz (incorporated herein
−Removed: by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K, filed with the SEC on January 29, 2019).
+Added: and Brian Lenz (incorporated herein by reference to Exhibit 10.3 to the Company’s
+Added: Current Report on Form 8-K, filed with the SEC on January 29, 2019).
Amendment to Employment Agreement, dated as of September 29, 2021, by and between ADMA Biologics, Inc.
−Removed: and Brian Lenz (incorporated by
−Removed: reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K, filed with the SEC on October 1, 2021).
−Removed: Plasma Purchase Agreement, dated as of November 17, 2011, by and between Biotest Pharmaceuticals Corporation and ADMA Biologics, Inc., as
−Removed: amended by First Amendment to Plasma Purchase Agreement, dated as of December 1, 2011, by and between Biotest Pharmaceuticals Corporation and ADMA Biologics, Inc.
+Added: and Brian Lenz (incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K, filed with the SEC on October
+Added: Plasma Purchase Agreement, dated as of November 17, 2011, by and between Biotest Pharmaceuticals Corporation and ADMA Biologics, Inc., as amended by First Amendment to Plasma Purchase Agreement, dated as of December 1, 2011, by and
+Added: between Biotest Pharmaceuticals Corporation and ADMA Biologics, Inc.
(incorporated herein by reference to Exhibit 10.9 to Amendment No.
−Removed: the Company’s Current Report on Form 8-K/A, filed with the SEC on June 22, 2012).
−Removed: Second Amendment to Plasma Purchase Agreement, dated as of December 18, 2015, by and between Biotest Pharmaceuticals Corporation and ADMA
−Removed: Biologics, Inc.
−Removed: (incorporated herein by reference to Exhibit 10.3.1 to the Company’s Annual Report on Form 10-K, filed with the SEC on March 23, 2016).
−Removed: Third Amendment to Plasma Purchase Agreement, dated as of April 8, 2016, by and between Biotest Pharmaceuticals Corporation and ADMA
−Removed: Biologics, Inc.
−Removed: (incorporated herein by reference to Exhibit 10.3.2 to the Company’s Quarterly Report on Form 10-Q, filed with the SEC on May 13, 2016).
−Removed: Fourth Amendment to Plasma Purchase Agreement, dated as of June 6, 2017, by and between Biotest Pharmaceuticals Corporation and ADMA
−Removed: Biologics, Inc.
−Removed: (incorporated herein by reference to Exhibit 10.9 to the Company’s Quarterly Report on Form 10-Q, filed with the SEC on August 11, 2017).
−Removed: Fifth Amendment to Plasma Purchase Agreement, dated as of January 1, 2019, by and between Grifols Worldwide Operations Limited (as
−Removed: successor-in-interest to Biotest Pharmaceuticals Corporation) and ADMA Biologics, Inc.
−Removed: (incorporated 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
−Removed: (incorporated herein by reference to Exhibit 10.5 to the Company’s Quarterly Report on Form 10-Q, 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
−Removed: BioManufacturing, LLC (incorporated herein by reference to Exhibit 10.2 to the Company’s Quarterly 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
−Removed: (incorporated herein by reference to Exhibit 10.6 to the Company’s Quarterly Report on Form 10-Q, 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
−Removed: BioManufacturing, LLC (incorporated herein by reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q, filed with the SEC on August 10, 2018).
−Removed: Amended and Restated Agreement for Services, effective as of January 1, 2016, as amended, by and between ADMA Biologics, LLC and Areth LLC
−Removed: (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).
+Added: 3 to the Company’s Current Report on Form 8-K/A, filed with the SEC on June 22, 2012).
+Added: Second Amendment to Plasma Purchase Agreement, dated as of December 18, 2015, by and between Biotest Pharmaceuticals Corporation and ADMA Biologics, Inc.
+Added: (incorporated herein by reference to Exhibit 10.3.1 to the Company’s Annual
+Added: Report on Form 10-K, filed with the SEC on March 23, 2016).
+Added: Third Amendment to Plasma Purchase Agreement, dated as of April 8, 2016, by and between Biotest Pharmaceuticals Corporation and ADMA Biologics, Inc.
+Added: (incorporated herein by reference to Exhibit 10.3.2 to the Company’s Quarterly Report
+Added: on Form 10-Q, filed with the SEC on May 13, 2016).
+Added: Fourth Amendment to Plasma Purchase Agreement, dated as of June 6, 2017, by and between Biotest Pharmaceuticals Corporation and ADMA Biologics, Inc.
+Added: (incorporated herein by reference to Exhibit 10.9 to the Company’s Quarterly Report on
+Added: Form 10-Q, filed with the SEC on August 11, 2017).
+Added: Fifth Amendment to Plasma Purchase Agreement, dated as of January 1, 2019, by and between Grifols Worldwide Operations Limited (as successor-in-interest to Biotest Pharmaceuticals Corporation) and ADMA Biologics, Inc.
+Added: (incorporated
+Added: 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).
+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,
+Added: filed 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
+Added: Report on Form 10-Q, filed with the SEC on August 10, 2018).
+Added: 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,
+Added: filed with the SEC on August 11, 2017).
+Added: 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: 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 Biologics, LLC and Areth LLC (incorporated herein by reference to Exhibit 10.18 to the Company’s Quarterly Report on Form
+Added: 10-Q, filed with the SEC on August 12, 2016).
Lease, effective as of February 17, 2017, by and between Home Center Properties, LLC and ADMA BioCenters Georgia Inc.
+Added: (incorporated herein by reference to Exhibit 10.22 to the Company’s Annual Report on Form 10-K, filed with the SEC on
+Added: February 24, 2017).
+Added: 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).
+Added: 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.
(incorporated herein
−Removed: by reference to Exhibit 10.22 to the Company’s Annual Report on Form 10-K, filed with the SEC on February 24, 2017).
−Removed: Form of Indemnification Agreement (incorporated herein by reference to Exhibit 10.12 to the Company’s Current Report on Form 8-K, filed
−Removed: 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
−Removed: Georgia Inc., ADMA BioManufacturing, LLC, and Perceptive Credit Holdings II, LP.
−Removed: (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed with the SEC on February 12, 2019).
+Added: by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed with the SEC on February 12, 2019).
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
−Removed: BioCenters Georgia Inc., ADMA BioManufacturing, LLC and Perceptive Credit Holdings II, LP (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).
+Added: 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
+Added: (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).
Amendment No.
−Removed: 2 to the Credit Agreement and Guaranty, dated December 8, 2020, by and among the Company, ADMA Plasma Biologics, Inc., ADMA
−Removed: BioCenters Georgia Inc., ADMA BioManufacturing, LLC and Perceptive Credit Holdings II, LP.
+Added: 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.
(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.,
−Removed: ADMA BioManufacturing, LLC, and Perceptive Credit Holdings II, LP.
−Removed: (incorporated herein by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K, filed with the SEC on February 12, 2019).
+Added: 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.
+Added: (incorporated herein by
+Added: 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.
−Removed: and Biotest AG (incorporated herein by reference
−Removed: to Exhibit 10.21 to the Company’s Registration Statement on Form S-1, filed with the SEC on February 11, 2013).
−Removed: First Amendment to License Agreement, dated as of June 6, 2017, by and between the Company and Biotest AG (incorporated herein by reference
−Removed: to Exhibit 10.8 to the Company’s Quarterly Report on Form 10-Q, filed with the SEC on August 11, 2017).
−Removed: Manufacturing Agreement, dated as of September 30, 2011, by and between ADMA BioManufacturing, LLC (as successor-in-interest to Biotest
−Removed: Pharmaceuticals Corporation) and Sanofi Pasteur S.A.
−Removed: (incorporated herein by reference to Exhibit 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
−Removed: successor-in-interest to Biotest Pharmaceuticals Corporation) and Sanofi Pasteur S.A.
−Removed: (incorporated herein by 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
−Removed: (incorporated herein by reference to Exhibit 10.24.2 to the Company’s Annual Report on Form 10-K, filed with the SEC on March 29, 2018).
−Removed: Stockholders Agreement, dated as of June 6, 2017,
−Removed: 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 June 12, 2017).
−Removed: Transition Services Agreement, dated as of
−Removed: January 1, 2019, by and between the Company and Biotest Pharmaceuticals Corporation.
−Removed: (incorporated herein by reference to Exhibit 10.22 to the Company’s Annual Report on Form 10-K, filed with the SEC on March 13, 2019)
−Removed: Amendment #1 to Transition Services Agreement,
−Removed: 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, 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
−Removed: Areth LLC (incorporated herein by reference to the Exhibit 10.27 to the Company’s Annual Report on Form 10-K filed March 12, 2020).
+Added: and Biotest AG (incorporated herein by reference to Exhibit 10.21 to the Company’s Registration Statement on Form S-1, filed with the SEC on
+Added: February 11, 2013).
+Added: 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
+Added: 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.
+Added: (incorporated herein by reference to Exhibit
+Added: 10.24 to the Company’s Annual Report on Form 10-K, filed with the SEC on March 29, 2018).
+Added: 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.
+Added: (incorporated herein by
+Added: reference to Exhibit 10.24.1 to the Company’s Annual Report on Form 10-K, filed with the SEC on March 29, 2018).
+Added: Amendment #3 to the Manufacturing Agreement, effective as of December 21, 2017, by and between ADMA BioManufacturing, LLC and Sanofi Pasteur S.A.
+Added: (incorporated herein by reference to Exhibit 10.24.2 to the Company’s Annual Report on
+Added: Form 10-K, filed with the SEC on March 29, 2018).
+Added: 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
+Added: June 12, 2017).
+Added: 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
+Added: the SEC on March 13, 2019).
+Added: 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,
+Added: filed on September 5, 2019).
+Added: 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
+Added: Form 10-K filed March 12, 2020).
+Added: 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).
Distribution Agreement, dated September 3, 2021, by and between ADMA Biologics, Inc.
1 unchanged sentence
(incorporated by reference to Exhibit 1.1 to the Company’s Current Report on Form 8-K filed on September 3,
−Removed: Form of Retention Bonus Agreement (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on
−Removed: October 1, 2021).
+Added: 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).
Separation Agreement and Release, dated August 6, 2021, by and between ADMA Biologics, Inc.
−Removed: and James Mond (incorporated by reference
−Removed: to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed on August 11, 2021).
−Removed: Credit Agreement and
−Removed: Guaranty, dated as of March 23, 2022, by and among the Company, Hayfin Services LLP and the lenders party thereto
−Removed: Security Agreement,
−Removed: dated as of March 23, 2022, by and among the Company, certain subsidiaries of the Company and Hayfin Services LLP.
+Added: 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).
+Added: 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
+Added: the SEC on March 24, 2022).
+Added: Amendment No.
+Added: 1 to Credit Agreement and Guaranty, dated March 23, 2023 by and among the Company, Hayfin Services LLP and the lenders party thereto.
+Added: 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
+Added: the SEC on March 24, 2022).
+Added: ADMA Biologics, Inc.
+Added: 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)
Subsidiaries of the Company.
Consent of CohnReznick LLP.
−Removed: Certification of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a), as adopted pursuant to
−Removed: Section 302 of the Sarbanes-Oxley Act of 2002.
−Removed: Certification of Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a), as adopted pursuant to
−Removed: Section 302 of the Sarbanes-Oxley Act of 2002.
+Added: Certification of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
+Added: Certification of Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
Certification of Principal Executive Officer pursuant to 18 U.S.C.
−Removed: Section 1350, as adopted pursuant to Section
−Removed: 906 of the Sarbanes-Oxley Act of 2002.
+Added: Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
Certification of Principal Financial Officer pursuant to 18 U.S.C.
−Removed: Section 1350, as adopted pursuant to Section
−Removed: 906 of the Sarbanes-Oxley Act of 2002.
+Added: Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
The following materials from ADMA Biologics, Inc.
63 unchanged sentences
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 reporting.
−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 reporting.
+Added: The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial
+Added: 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
Accordingly, we express no such opinion.
6 unchanged sentences
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
−Removed: required to be communicated to the audit committee and that:
−Removed: (1) relate to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments.
−Removed: 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 a separate opinion on the
−Removed: critical audit matters or on the accounts or disclosures to 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 required to be communicated to the audit committee
+Added: (1) relate to accounts or disclosures that are material to the consolidated financial statements, and (2) involved especially challenging, subjective, or complex judgments.
+Added: The communication of critical audit matters does not alter in
+Added: 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
+Added: which they relate.
Description of the matter
14 unchanged sentences
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
−Removed: protection arrangements and customer incentives, including prompt pay discounts, wholesaler chargebacks and other wholesaler fees.
−Removed: Estimated rebates are also attributable to government programs that mandate various reductions from list price,
−Removed: which are reflected as liabilities and settled through cash payments.
+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 protection arrangements and customer incentives, including prompt pay discounts,
+Added: wholesaler chargebacks and other wholesaler fees.
+Added: 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.
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 and
−Removed: judgements 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 prices,
−Removed: unbilled claims and claims submission time lags.
+Added: Medicaid, Medicare Part D, and managed care is complex because of the subjectivity of certain assumptions
+Added: and judgments required to develop estimates.
+Added: These significant assumptions and judgments include consideration of legal interpretations of applicable laws and regulations, historical claims experience, payer channel mix, current contract
+Added: 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 the Company’s process to estimate rebate liabilities to devise our responsive audit approach.
−Removed: We performed substantive test procedures
−Removed: related to the rebate accruals, which included testing the significant 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
−Removed: To address the completeness of the reserves, we also assessed the historical accuracy of management’s estimates by comparing actual activity to previous estimates and performing analytical procedures.
−Removed: Finally, we considered subsequent
−Removed: events and any new information after the financial statement date that would require an adjustment to the accruals.
+Added: We obtained an understanding of the Company’s process to estimate rebate liabilities to devise our responsive audit approach.
+Added: We performed substantive test procedures related to the rebate accruals, which included testing the significant
+Added: assumptions and mathematical accuracy.
+Added: We tested the completeness and accuracy of the data used in the estimates and developed expectations of the key inputs using independent sources.
+Added: To address the completeness of the reserves, we also
+Added: assessed the historical accuracy of management’s estimates by comparing actual activity to previous estimates and performing analytical procedures.
+Added: Finally, we considered subsequent events and any new information after the financial statement
+Added: date that would require an adjustment to the accruals.
Liquidity Analysis
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
−Removed: liquidity to satisfy obligations for at least one year from the date of 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
−Removed: and therefore a critical audit matter as such are complex.
−Removed: Finally, 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
+Added: 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
+Added: issuance of these consolidated financial statements.
+Added: 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.
+Added: 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.
How we addressed the matter in our audit
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
−Removed: 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
−Removed: the projected funds.
−Removed: We compared the data provided to sensitivity adjusted projections, made inquiries of management and applied our industry knowledge.
−Removed: Finally, we considered management’s overall ability to put forth reasonable projections based
−Removed: on the performance of retrospective audit procedures on historic cash flow projections and based on the results of audit procedures applied to other estimates .
+Added: We obtained and audited management’s projections, considering their completeness with respect to cash obligations.
+Added: 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.
+Added: We compared the data provided to sensitivity adjusted
+Added: projections, made inquiries of management and applied our industry knowledge.
+Added: Finally, we considered management’s overall ability to put forth reasonable projections based on the performance of retrospective audit procedures on historic cash
+Added: flow projections and based on the results of audit procedures applied to other estimates .
/s/ CohnReznick LLP
We have served as the Company’s auditor since 2008.
−Removed: Holmdel, New Jersey
+Added: Parsippany, New Jersey
March 23, 2023
1 unchanged sentence
AND SUBSIDIARIES
−Removed: CONSOLIDATED BALANCE SHEETS
+Added: BALANCE SHEETS
December 31, 2022 and 2021
17 unchanged sentences
Deferred revenue, net of current portion
+Added: End of term fee
Lease obligations, net of current portion
3 unchanged sentences
STOCKHOLDERS’ EQUITY
−Removed: Preferred Stock, $ 0.0001 par value, 10,000,000 shares authorized, no shares issued
−Removed: and outstanding
−Removed: Common Stock - voting, $ 0.0001 par value, 300,000,000 and 150,000,000 shares authorized, 195,813,817 and 104,902,888
+Added: Preferred Stock, $ 0.0001 par value, 10,000,000 shares authorized, no
shares issued and outstanding
+Added: Common Stock - voting, $ 0.0001 par value, 300,000,000 shares authorized, 221,816,930
+Added: and 195,813,817 shares issued and outstanding
Additional paid-in capital
7 unchanged sentences
AND SUBSIDIARIES
−Removed: CONSOLIDATED STATEMENTS OF OPERATIONS
+Added: CONSOLIDATED STATEMENTS OF
Years Ended December 31, 2022 and 2021
4 unchanged sentences
Cost of product revenue
−Removed: Gross profit (loss)
OPERATING EXPENSES:
8 unchanged sentences
Interest expense
−Removed: Gain on extinguishment of debt
+Added: Loss on extinguishment of debt
Other expense
6 unchanged sentences
AND SUBSIDIARIES
−Removed: CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
+Added: CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’
Years Ended December 31, 2022 and 2021
3 unchanged sentences
Stock-based compensation
−Removed: Warrants issued in connection with note payable
−Removed: Vesting of Restricted Stock Units
Issuance of common stock, net of offering expenses
−Removed: Stock options exercised
+Added: Vesting of Restricted Stock Units, net of shares withheld for taxes and retired
Balance at December 31, 2021
1 unchanged sentence
Stock-based compensation
−Removed: Vesting of Restricted Stock Units, net of shares withheld for taxes and retired
+Added: Warrants issued in connection with note payable
+Added: Vesting of Restricted Stock Units, net of shares withheld for taxes
+Added: Stock options exercised
Issuance of common stock, net of offering expenses
4 unchanged sentences
AND SUBSIDIARIES
−Removed: CONSOLIDATED STATEMENTS OF CASH FLOWS
+Added: CONSOLIDATED STATEMENTS OF
Years Ended December 31, 2022 and 2021
4 unchanged sentences
Loss on disposal of fixed assets
+Added: Interest paid in kind
Stock-based compensation
Amortization of debt discount
−Removed: Gain on extinguishment of debt
+Added: Loss on extinguishment of debt
Amortization of license revenue
8 unchanged sentences
( 112,368,982
−Removed: ( 102,002,958
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment
−Removed: Proceeds from the sale of property and equipment
Net cash used in investing activities
1 unchanged sentence
Principal payments on notes payable
+Added: ( 100,000,000
Proceeds from issuance of common stock, net of offering expenses
−Removed: Proceeds from the exercise of stock options
Payment of debt refinancing fees
2 unchanged sentences
Payments on finance lease obligations
+Added: Proceeds from the exercise of stock options
+Added: Payment of deferred financing fees
Net cash provided by financing activities
−Removed: Net (decrease) increase in cash and cash equivalents
+Added: Net increase (decrease) in cash and cash equivalents
Cash and cash equivalents - beginning of year
16 unchanged sentences
Biotest AG, “Biotest”) on June 6, 2017.
−Removed: The acquisition included certain assets (the “Biotest Assets”) of BTBU, which included the FDA-licensed BIVIGAM and Nabi-HB immunoglobulin products, and an FDA-licensed plasma fractionation manufacturing
−Removed: facility located in Boca Raton, FL (the “Boca Facility”) (the “Biotest Transaction”).
+Added: The acquisition included certain assets (the “Biotest Assets”) of BTBU, which included the U.S.
+Added: Food and Drug Administration (“FDA”)-licensed BIVIGAM and Nabi-HB immunoglobulin products, and an FDA-licensed
+Added: plasma fractionation manufacturing facility located in Boca Raton, FL (the “Boca Facility”) (the “Biotest Transaction”).
BTBU had previously been the Company’s third-party contract manufacturer.
−Removed: ADMA BioCenters is the Company’s source plasma collection business with ten plasma collection facilities in various stages of approval and development located throughout the U.S., five of which hold an approved license with the U.S.
−Removed: Food and Drug Administration (the “FDA”).
+Added: ADMA BioCenters is the Company’s source plasma
+Added: collection business with ten plasma collection facilities located throughout the U.S., eight of which hold an approved license with the FDA.
The Company has three
1 unchanged sentence
(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”), and for which the Company received FDA approval on May 9, 2019 and commenced commercial sales in August 2019;
−Removed: (ii) ASCENIV (Immune Globulin Intravenous, Human –
−Removed: 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 Immune Globulin, Human), which
−Removed: 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 products, the Company provides contract
−Removed: 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 develop a pipeline of plasma-derived
−Removed: 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: 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;
+Added: (ii) ASCENIV (Immune
+Added: 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;
+Added: and (iii) Nabi-HB (Hepatitis B
+Added: 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.
+Added: In addition to its commercially available immunoglobulin
+Added: 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.
+Added: The Company seeks to
+Added: 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.
As of December 31, 2022, the Company had working capital of $ 231.1 million, including $ 86.5 million of cash and cash equivalents.
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, together with the remaining available funds under the distribution agreement discussed in Note 8 and the net proceeds received and expected to be received from the refinancing of the
−Removed: Company’s senior debt on March 23, 2022 (see Note 17), will be sufficient to fund ADMA’s operations, as currently conducted, into the first quarter of 2024, at which time the Company believes it will begin to generate positive cash flow from
−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 correct and
−Removed: 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 buildouts or other
−Removed: 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 industries including, but
−Removed: 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, protection of proprietary
−Removed: technology, and compliance with FDA and other governmental regulations and approval requirements.
−Removed: The Company is also continuing to evaluate a variety of strategic and financing alternatives through its ongoing engagement with Morgan Stanley as a
−Removed: financial advisor.
+Added: 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
+Added: cash flow from operations.
+Added: 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
+Added: correct and the acceptability of ADMA’s immune globulin products by physicians, patients or payers.
+Added: There can be no assurance that the Company’s approved products will be commercially viable, or that plant capacity expansion, plasma center
+Added: buildouts or other capital improvements will be successfully completed or that any product developed in the future will be approved.
+Added: The Company is subject to risks common to companies in the biotechnology and pharmaceutical manufacturing
+Added: 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,
+Added: protection of proprietary technology, and compliance with FDA and other governmental regulations and approval requirements.
ADMA BIOLOGICS, INC.
2 unchanged sentences
DECEMBER 31, 2022 AND 2021
−Removed: During the year ended December 31, 2021, the Company issued 90,846,029 shares of its common stock through an underwritten public offering and various open market sale agreements for its common stock and received net proceeds of $ 121.1 million.
+Added: The Company continues to evaluate a variety of strategic alternatives through its ongoing engagement with Morgan Stanley.
+Added: The exploration
+Added: of value-creating opportunities remains a top corporate priority for ADMA.
+Added: On December 9, 2022, the Company issued 24,125,873
+Added: shares of its common stock through an underwritten public offering and received net proceeds of $ 64.6 million, and on March 23, 2022
+Added: the Company received approximately $ 47.0 million in net proceeds from the refinancing of its senior credit facility (see Note 7).
SIGNIFICANT ACCOUNTING POLICIES
13 unchanged sentences
Actual results could differ from those estimates.
−Removed: Significant estimates include the realizable value of accounts receivable, valuation of inventory, assumptions used in projecting future liquidity and capital requirements, assumptions used in the fair value of awards granted under the Company’s
−Removed: 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, the realizable value of accounts receivable, valuation of inventory, assumptions used in projecting future liquidity and capital requirements, assumptions used in
+Added: 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.
Cash and cash equivalents
9 unchanged sentences
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, 2021 and December 31, 2020, 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
−Removed: customer’s financial condition and credit history.
+Added: December 31, 2022 and 2021, respectively, 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
+Added: condition and credit history.
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
−Removed: risk is minimal.
−Removed: (see Note 16).
+Added: Based on these evaluations, the Company has concluded that its credit risk is minimal (see
Raw materials inventory consists of various materials purchased from suppliers, including normal source plasma, used in the production of
10 unchanged sentences
or research and development activities, are carried at the lower of cost or net realizable value determined by the first-in, first-out method.
−Removed: Net realizable value is generally determined based upon the consideration the Company expects to
−Removed: receive when the inventory is sold, less costs to deliver the inventory to the recipient.
−Removed: The estimates for net realizable value of inventory are based on contractual terms or upon historical experience and certain other assumptions, and the
−Removed: Company believes that such assumptions are reasonable.
−Removed: Inventory is periodically reviewed to ensure that its carrying value does not exceed its net realizable value, and adjustments are recorded to write down such inventory, with a corresponding
−Removed: charge to cost of product revenue, when the carrying value or historical cost exceeds its estimated net realizable value.
−Removed: In addition, costs associated with the production of conformance or engineering lots that would not qualify as immediately
−Removed: available for commercial sale are charged to cost of product revenue and not capitalized into inventory.
+Added: For both the Company’s immune globulin products and plasma intended for resale and internal use, net
+Added: realizable value is generally determined based upon the consideration the Company expects to receive when the inventory is sold, less costs to deliver the inventory to the recipient.
+Added: The estimates for net realizable value of inventory are based
+Added: on contractual terms or upon historical experience and certain other assumptions, and the Company believes that such assumptions are reasonable.
+Added: Inventory is periodically reviewed to ensure that its carrying value does not exceed its net
+Added: realizable value, and adjustments are recorded to write down such inventory, with a corresponding charge to cost of product revenue, when the carrying value or historical cost exceeds its estimated net realizable value.
+Added: In addition, costs
+Added: 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.
Property and equipment
43 unchanged sentences
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 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 intermediates, control transfers to
−Removed: 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: These estimates are based on contractual arrangements, historical experience and certain other assumptions, and the Company believes that such estimates are reasonable.
+Added: For revenues associated with contract manufacturing and the sale of
+Added: 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.
Product revenues from the sale of human plasma collected at the Company’s plasma collection centers are recognized at the time control of
2 unchanged sentences
Cost of product revenue
−Removed: Cost of product revenue includes costs associated with the manufacture of the Company’s FDA approved products, intermediates and the sale
−Removed: of human source plasma, as well as expenses related to conformance batch production, process development and scientific and technical operations when these operations are attributable to marketed products.
−Removed: When the activities of these operations
−Removed: are attributable to new products in development, the expenses are classified as research and development expenses.
+Added: Cost of product revenue includes costs associated with the manufacture of the Company’s FDA approved products and intermediates and for
+Added: the collection of human source plasma, as well as expenses related to conformance batch production, process development and scientific and technical operations when these operations are attributable to marketed products.
+Added: When the activities of
+Added: these operations are attributable to new products in development, the expenses are classified as research and development expenses.
Research and development expenses
2 unchanged sentences
All research and development costs are expensed as incurred.
+Added: Plasma center operating expenses
+Added: Plasma center operating expenses consist of certain general and administrative plasma center costs, initial opening, marketing and
+Added: 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.
Advertising and marketing expenses
45 unchanged sentences
Recent Accounting Pronouncements
−Removed: In June 2016, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) No.
−Removed: 2016-13, Financial
−Removed: Instruments – Credit Losses (Topic 326) (“ASU 2016-13”), which requires financial assets to be presented at the net amount expected to be collected, with an allowance for credit losses to be deducted from the amortized cost basis of the
−Removed: financial asset such that the net carrying value of the asset is presented as the amount expected to be collected.
−Removed: Under ASU 2016-13, the entity’s statement of operations is required to reflect the measurement of credit losses for newly
−Removed: recognized financial assets, as well as expected increases or decreases in expected credit losses that have taken place during the period.
−Removed: For public business entities, ASU 2016-13 is effective for fiscal years beginning after December 15, 2019.
−Removed: The Company adopted ASU No.
−Removed: 2016-13 on January 1, 2020, and the adoption of this update did not have a significant impact on the Company’s consolidated financial statements.
+Added: There were no new accounting
+Added: pronouncements adopted during the years ended December 31, 2022 and 2021 that had a significant impact on the Company’s consolidated financial statements.
ADMA BIOLOGICS, INC.
14 unchanged sentences
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 center which is expected to be sold to third-party customers.
+Added: 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
Property and equipment at December 31, 2022 and 2021 is summarized as follows:
+Added: December 31, 2022
+Added: December 31, 2021
Manufacturing and laboratory equipment
20 unchanged sentences
DECEMBER 31, 2022 AND 2021
−Removed: Under the previous contract manufacturing agreement between ADMA and BPC, intermediate by-products derived from the manufacture of ASCENIV
−Removed: were property of Biotest.
+Added: Under the previous contract manufacturing agreement between ADMA and BPC, intermediate by-products derived from
+Added: the manufacture of ASCENIV were property of Biotest.
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 .
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, 2021 and 2020 was $ 0.7 million.
+Added: Amortization expense related to the Company’s intangible assets for the years ended December 31, 2022 and 2021 was
+Added: $ 0.7 million.
Estimated aggregate future aggregate amortization expense is expected to be as follows:
7 unchanged sentences
Accrued testing
−Removed: Accrued payroll
+Added: Accrued payroll and other compensation
Total accrued expenses and other current liabilities
2 unchanged sentences
A summary of outstanding senior notes payable is as follows:
+Added: December 31, 2022
+Added: December 31, 2021
Notes payable
1 unchanged sentence
Senior notes payable
−Removed: On February 11, 2019 (the “Perceptive Closing Date”), the Company and all of its subsidiaries entered into a Credit Agreement and Guaranty
−Removed: (the “Perceptive Credit Agreement”) with Perceptive Credit Holdings II, LP, as the lender and administrative agent (“Perceptive”).
−Removed: The Perceptive Credit Agreement, as amended, provides for a senior secured term loan facility in a principal amount
−Removed: of $ 100.0 million (the “Perceptive Credit Facility”), comprised of (i) a term loan made on the Perceptive Closing Date in the principal
−Removed: amount of $ 45.0 million, as evidenced by the Company’s issuance of a promissory note (the “Perceptive Tranche I Note”) in favor of
−Removed: Perceptive on the Perceptive Closing Date (the “Perceptive Tranche I Loan”), (ii) a term loan in the principal amount of $ 27.5 million
−Removed: (the “Perceptive Tranche II Loan”) evidenced by the Company’s issuance of a promissory note (the “Perceptive Tranche II Note”) in favor of Perceptive on May 3, 2019, (iii) a term loan in the principal amount of $ 12.5 million evidenced by the Company’s issuance of a promissory note (the “Perceptive Tranche III Note”) in favor of Perceptive on March 20, 2020
−Removed: (the “Perceptive Tranche III Loan”);
−Removed: and (iv) a term loan in the principal amount of $ 15 million evidenced by our issuance of a
−Removed: promissory note in favor of Perceptive on December 8, 2020 (the “Perceptive Tranche IV Loan”, and together with the Perceptive Tranche I Loan, the Perceptive Tranche II Loan and the Perceptive Tranche III Loan, the “Perceptive Loans”).
−Removed: Perceptive Tranche III Loan is the result of an amendment to the Perceptive Credit Agreement that the Company and Perceptive entered into on May 3, 2019 (the “First Perceptive Amendment”), and the Perceptive Tranche III Loan became available to
−Removed: the Company upon the approval of BIVIGAM on May 9, 2019.
−Removed: The Perceptive Tranche IV Loan is the result of an amendment to the Perceptive Credit Facility entered into on December 8, 2020 (the “Second Perceptive Amendment”), which also extended the
−Removed: maturity date of the Perceptive Credit Facility to March 1, 2024 (the “Maturity Date”), subject to acceleration pursuant to the
−Removed: Perceptive Credit Agreement, including upon an Event of Default (as defined in the Perceptive Credit Agreement).
−Removed: Also on December 8, 2020, the Company retired a subordinated note payable to Biotest in the principal amount of $ 15.0 million with the proceeds from the Perceptive Tranche IV Loan.
−Removed: As part of this transaction, Biotest agreed to a 7 % discount from the principal, and the obligation under the note was satisfied by a payment by the Company of approximately $ 14.0 million.
−Removed: As a result, the Company recorded a gain on the extinguishment of the note of approximately $ 1.0 million.
+Added: On March 23, 2022 (the “Hayfin Closing Date”), the Company and all of its subsidiaries entered into a Credit and Guaranty Agreement (the “Hayfin
+Added: Credit Agreement”) with Hayfin Services LLP (“Hayfin”).
+Added: 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
+Added: amount of $ 25.0 million (the “ Hayfin Delayed Draw Loan ” and, together with the Hayfin Closing Date Loan, the “Hayfin Loans ”).
+Added: The obligation of the lenders to make the Hayfin Delayed Draw Loan was to expire on March 22, 2023
+Added: (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.
+Added: Credit Facility has a maturity date of March 23, 2027 (the “Hayfin Maturity Date”), subject to acceleration pursuant to the Hayfin
+Added: Credit Agreement, including upon an Event of Default (as defined in the Hayfin Credit Agreement).
ADMA BIOLOGICS, INC.
2 unchanged sentences
DECEMBER 31, 2022 AND 2021
−Removed: under the Perceptive Credit Agreement bear interest at a rate per annum equal to 7.5 % plus the greater of (i) one-month LIBOR and (ii) 3.5 %;
−Removed: provided, however, that upon, and during the continuance of, an Event of Default, the interest rate will automatically increase by an additional 400
−Removed: basis points.
−Removed: Accrued interest was payable to Perceptive on the last day of each month during the term of the Perceptive Credit Facility.
−Removed: The rate of interest in effect as of the Perceptive Closing Date and at December 31, 2021 was 11.0 %.
−Removed: the Maturity Date, the Company was to have paid Perceptive the entire outstanding principal amount underlying the Perceptive Loans and any accrued and unpaid interest thereon.
−Removed: There were no scheduled principal payments on the Perceptive Loans
−Removed: prior to the Maturity Date.
−Removed: On March 23, 2022, the Company retired in full all of its outstanding obligations under the Perceptive Credit Agreement, including a redemption premium of $ 2.0 million per the amended terms of the Perceptive Credit Agreement, using the proceeds received from a new senior credit facility the Company entered into on that date (see Note 17).
−Removed: Company’s obligations under the Perceptive Credit Agreement were 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 equity
−Removed: interests in the Company’s subsidiaries.
−Removed: The Perceptive Credit Agreement contained certain representations and warranties, affirmative covenants, negative covenants and conditions that are customarily required for similar financings.
−Removed: covenants restricted or limited the ability of the Company and its subsidiaries to, among other things and subject to certain exceptions contained in the Perceptive Credit Agreement, incur new indebtedness;
+Added: 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
+Added: obligations under the Company’s previously existing credit facility (the “Perceptive Credit Facility”) with Perceptive Credit Holdings II, LP (“Perceptive”).
+Added: 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.
+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
+Added: Hayfin Credit Agreement.
+Added: 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: Borrowings under the Hayfin
+Added: 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
+Added: 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 %),
+Added: 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
+Added: provided, however, that upon, and during the continuance of, an Event of Default, the Applicable Margin shall increase by an additional 3 %
+Added: 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.
+Added: The rate of interest in effect as of the Hayfin Closing Date and as of December 31,
+Added: 2022 was 10.75 % and approximately 13.9 %,
+Added: respectively.
+Added: 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.
+Added: From the Hayfin Closing Date through December 31, 2022,
+Added: approximately $ 3.0 million of interest was paid in kind and added to the balance of the outstanding Hayfin Loans.
+Added: On the Hayfin Maturity Date, the
+Added: 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.
+Added: This exit fee is recorded separately as a non-current liability on the accompanying consolidated balance sheet as of December 31, 2022.
+Added: Prior to the Hayfin
+Added: Maturity Date, there are no scheduled principal payments on the Hayfin Loans.
+Added: The Company may prepay outstanding principal on the
+Added: Hayfin Loans at any time and from time to time upon five business days’ prior written notice, subject to the payment to Hayfin of,
+Added: (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 %
+Added: of the prepaid principal amount, if prepaid on or prior to the first anniversary of the Hayfin Closing Date, (ii) 3.0 % of the
+Added: 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
+Added: 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.
+Added: 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
+Added: equity interests in the Company’s subsidiaries.
+Added: Credit Agreement contains certain representations and warranties, affirmative covenants, negative covenants and conditions that are customarily required for similar financings.
+Added: The negative covenants restrict or limit the ability of the Company
+Added: and its subsidiaries to, among other things and subject to certain exceptions contained in the Hayfin Credit Agreement, incur new indebtedness;
create liens on assets;
−Removed: certain fundamental corporate changes, such as mergers or acquisitions, or changes to the Company’s or its subsidiaries’ business activities;
−Removed: make certain Investments or Restricted Payments (each as defined in the Perceptive Credit Agreement);
+Added: engage in certain fundamental corporate changes, such as mergers or acquisitions, or changes to the Company’s or its
+Added: subsidiaries’ business activities;
+Added: make certain Investments or Restricted Payments (each as defined in the Hayfin Credit Agreement);
change its fiscal year;
pay dividends;
−Removed: repay other certain indebtedness;
+Added: repay certain other indebtedness;
engage in certain affiliate transactions;
−Removed: or enter into, amend or terminate any other agreements that had the impact of restricting the Company’s ability to make loan
−Removed: repayments under the Perceptive Credit Agreement.
−Removed: In addition, the Company was required (i) at all times prior to the Maturity Date to maintain a minimum cash balance of $ 3.0 million;
−Removed: and (ii) as of the last day of each fiscal quarter commencing with the fiscal quarter ended June 30, 2019, report revenues for the trailing 12-month period that exceed the
−Removed: amounts set forth in the Perceptive Credit Agreement, which ranged from $ 7.0 million for the fiscal quarter ended June 30, 2019 to $ 55.0 million for the fiscal quarter ending December 31, 2021.
−Removed: At December 31, 2021, the Company was in compliance with all of the covenants contained
−Removed: in the Perceptive Credit Agreement.
−Removed: consideration for the Perceptive Credit Agreement, the Company issued to Perceptive a warrant to purchase 1,360,000 shares of the
−Removed: Company’s common stock (the “Perceptive Warrant”) on the Perceptive Closing Date.
−Removed: The Perceptive Warrant has an exercise price equal to $ 3.28
−Removed: per share, which is equal to the trailing 10-day volume weighted average price (“VWAP”) of the Company’s common stock on the business
−Removed: day immediately prior to the Perceptive Closing Date multiplied by 1.15 .
−Removed: The Company valued the Perceptive Warrant at $ 2.7 million as of the Perceptive Closing Date and it has an expiration date of February 11, 2029 .
−Removed: In connection with the First Perceptive Amendment, the Company issued an additional warrant (the “Perceptive Tranche III Warrant”) to purchase 250,000 shares of the Company’s common stock to Perceptive with an exercise price equal to $ 4.64 per share, which represents the trailing 10-day VWAP of the Company’s
−Removed: common stock as of May 2, 2019.
−Removed: The Perceptive Tranche III Warrant was valued by the Company at $ 0.9 million and has an expiration date
−Removed: of May 3, 2029 .
−Removed: As consideration for the Second Perceptive Amendment, the Company issued an additional warrant (the “Perceptive
−Removed: Tranche IV Warrant” and, together with the Perceptive Warrant and the Perceptive Tranche III Warrant, the “Perceptive Warrants”) to purchase 2,390,000
−Removed: shares of the Company’s common stock to Perceptive with an exercise price of $ 1.94 per share, which is equal to the trailing 10-day VWAP of the Company’s common stock on the business day immediately prior to the date of the Perceptive Second Amendment.
−Removed: The Perceptive Tranche
−Removed: IV Warrant was valued by the Company at $ 3.7 million and has an expiration date of December 8, 2030 .
−Removed: Perceptive had represented to the Company, among other things, that it was an “accredited investor” (as such term is defined in Rule 501(a) of Regulation D
−Removed: under the Securities Act) and the Company issued the Perceptive Warrants in reliance upon an exemption from registration contained in Section 4(2) under the Securities Act.
−Removed: The Perceptive Warrants and the shares of common stock issuable
−Removed: thereunder may not be offered, sold, pledged or otherwise transferred in the U.S.
−Removed: absent registration or an applicable exemption from the registration requirements under the Securities Act.
+Added: or enter into, amend or terminate any
+Added: other agreements that have the impact of restricting the Company’s ability to make loan repayments under the Hayfin Credit Agreement.
+Added: 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: 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
+Added: the amounts set forth in the Hayfin Credit Agreement,
+Added: 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.
+Added: As of December 31, 2022, the Company was in compliance with all of the covenants contained in the Hayfin Credit Agreement.
+Added: As consideration for the Hayfin
+Added: 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: shares of the Company’s common stock (the “Hayfin Warrants”).
+Added: The Hayfin Warrants have an exercise price equal to $ 1.6478 per share,
+Added: which is equal to the trailing 30 -day Volume Weighted-average Price of the Company’s common stock on the business day immediately
+Added: prior to the Hayfin Closing Date.
+Added: The Hayfin Warrants were valued by the Company at approximately $ 9.6 million as of the Hayfin Closing
+Added: Date and have an expiration date of March 23, 2029 .
ADMA BIOLOGICS, INC.
2 unchanged sentences
DECEMBER 31, 2022 AND 2021
−Removed: As a result of the fees paid to Perceptive and the value of the Perceptive Warrants, the Company recognized an aggregate discount on the Perceptive Loans in the amount of $ 7.1 million.
−Removed: The Company records debt discount as a reduction to the face amount of the debt, and the debt discount is amortized as interest expense
−Removed: over the life of the debt using the interest method.
−Removed: Based on the fair value of the Perceptive Warrants and the aggregate amount of fees and expenses associated with obtaining the Perceptive Credit Facility, the effective interest rate on the
−Removed: Perceptive Loans since December 8, 2020 was approximately 13.7 %.
+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 the value of the Hayfin Warrants, the Company recognized an aggregate discount on the
+Added: Hayfin Loans in the amount of $ 13.9 million.
+Added: The Company records debt discount as a reduction to the face amount of the debt, and
+Added: the debt discount is amortized as interest expense over the life of the debt using the interest method.
+Added: Based on the fair value of the Hayfin Warrants and the aggregate amount of fees and expenses associated with obtaining the Hayfin Credit
+Added: 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 %
+Added: and 16.1 %, respectively.
STOCKHOLDERS ’ EQUITY
1 unchanged sentence
The Company is currently authorized to issue up to 10 million shares of preferred stock, $ 0.0001 par value per share.
−Removed: were no shares of preferred stock outstanding at December 31, 2021 and 2020.
−Removed: December 31, 2021 and 2020, the Company was authorized to issue 300,000,000 and 150,000,000 shares, respectively, of its common stock, $ 0.0001
−Removed: par value per share, and 195,813,817 and 104,902,888
−Removed: shares of common stock were outstanding as of December 31, 2021 and 2020, respectively.
−Removed: On May 27, 2021, the Company amended its Second Amended and Restated Certificate of Incorporation to increase the number of shares of common stock that the
−Removed: Company is authorized to issue from 150,000,000 to 300,000,000 .
−Removed: After giving effect to shares reserved for the issuance of warrants and for awards issued under the Company’s equity incentive plans, 87,241,078 shares of common stock were available for issuance as of December 31, 2021.
−Removed: On October 25, 2021, the Company completed an underwritten public offering whereby the Company issued 57.5
−Removed: million shares of common stock and received gross proceeds of $ 57.5 million.
−Removed: Net proceeds after underwriting discounts and expenses
−Removed: associated with the offering, were approximately $ 53.8 million, and are being used (i) to advance the commercial sales of the Company’s
−Removed: FDA approved products through the procurement of raw materials for the manufacturing of BIVIGAM and ASCENIV;
−Removed: (ii) to expand the Company’s plasma collection facility network;
−Removed: (iii) to scale up the manufacturing capacity of the Boca Facility
−Removed: and make continuous improvements in order to adhere to cGMP compliance;
−Removed: (iv) to explore business development opportunities;
−Removed: and (v) for general corporate purposes and other capital expenditures.
+Added: There were no shares of preferred stock outstanding at December 31, 2022 and 2021.
+Added: December 31, 2022 and 2021, the Company was authorized to issue 300,000,000 shares of its common stock, $ 0.0001 par value per share, and 221,816,930
+Added: and 195,813,817 shares of common stock were outstanding as of December 31, 2022 and 2021, respectively.
+Added: On May 27, 2021, the Company
+Added: amended its Second Amended and Restated Certificate of Incorporation to increase the number of shares of common stock that the Company is authorized to issue from 150,000,000 to 300,000,000 .
+Added: After giving effect to shares reserved for the
+Added: issuance of warrants and for awards issued under the Company’s equity incentive plans, 29,177,763 shares of common stock were
+Added: available for issuance as of December 31, 2022.
+Added: On December 9, 2022, the Company completed an underwritten public offering whereby the Company issued 24,125,873
+Added: shares of its common stock.
+Added: Net proceeds after underwriting discounts and expenses associated with the offering were approximately $ 64.6
+Added: 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: capital expenditures and general corporate purposes.
+Added: During the year
+Added: ended December 31, 2022, outstanding stock options aggregating to 68,679 shares of common stock were exercised, and the Company
+Added: received net proceeds from the exercises of approximately $ 0.2 million.
+Added: On October 25, 2021,
+Added: the Company completed an underwritten public offering whereby the Company issued 57.5 million shares of common stock and received
+Added: gross proceeds of $ 57.5 million.
+Added: Net proceeds after underwriting discounts and expenses associated with the offering were approximately
+Added: $ 53.8 million, and were used to advance the commercial sales of the Company’s FDA approved products through the procurement of raw
+Added: materials for the manufacturing of BIVIGAM and ASCENIV, to expand the Company’s plasma collection facility network, to scale up the manufacturing capacity of the Boca Facility and make continuous improvements in order to adhere to cGMP
+Added: compliance, to explore business development opportunities and for general corporate purposes and other capital expenditures.
+Added: ADMA BIOLOGICS, INC.
+Added: AND SUBSIDIARIES
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: 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,
3 unchanged sentences
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: During the year ended
−Removed: December 31, 2021, the Company issued 5,540,831 shares of its common stock under the Distribution Agreement and received net
−Removed: proceeds of $ 6.9 million.
−Removed: ADMA BIOLOGICS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: DECEMBER 31, 2021 AND 2020
−Removed: On August 5, 2020, the Company entered into an open market sale agreement (as amended from time to time, the “Sale Agreement”) with Jefferies LLC (“Jefferies”), pursuant to which the Company could offer and sell, from time to time, at its
−Removed: option, through or to Jefferies, up to an aggregate of $ 50 million of shares of the Company’s common stock.
−Removed: On November 5, 2020 and
−Removed: February 3, 2021, the Company and Jefferies amended the Sale Agreement to provide for increases in the aggregate offering amount under the Sale Agreement such that the Company could sell shares having an aggregate offering price of up to $ 105.4 million under the Sale Agreement, as amended.
−Removed: For the year ended December 31, 2021, the Company issued and sold 27,805,198 shares of common stock under the 2020 Sale Agreement and received net proceeds of $ 60.4 million.
−Removed: For the year ended December 31, 2020, the Company sold 18,537,907
−Removed: shares of common under the Sale Agreement and received net proceeds of $ 42.5 million.
−Removed: On February 11, 2020, the Company completed an underwritten public offering of 23,500,000 shares of its common stock for gross
−Removed: proceeds of $ 82.3 million.
−Removed: On February 21, 2020, the Company sold an additional 3,525,000 shares pursuant to the underwriters’ exercise of their option to purchase additional shares of the Company’s common stock for additional gross proceeds of $ 12.3 million.
−Removed: The Company received net proceeds, after underwriting discounts and other expenses associated with the offering, of approximately $ 88.7 million.
−Removed: During the year ended December 31, 2020, the Company issued 6,626 shares of common stock in connection with the exercise of
−Removed: stock options that had been granted to employees.
−Removed: On December 8, 2020, the Company issued the Perceptive Tranche IV Warrant, whereby Perceptive may purchase an aggregate of 2,390,000
−Removed: shares of common stock at an exercise price $ 1.94 per share (see Note 7).
−Removed: The warrant was valued at $ 3.7 million, using the Black-Scholes option-pricing model assuming an expected term of 10 years , a volatility of 69.3 %, a dividend yield of 0 % and a risk-free interest rate of 0.92 %.
−Removed: At December 31, 2021 and 2020, the Company had outstanding warrants to purchase an aggregate of 4,528,160 shares of common stock, with a weighted average exercise price of $ 2.82 per share and expiration dates ranging between June 2022 and December 2030.
−Removed: Incentive Plans
−Removed: From time to time the Company grants stock options or other equity-based awards under the Company’s Amended and Restated 2014 Omnibus Incentive Compensation Plan (the “2014 Plan”).
+Added: T he Company currently has approximately $ 42.8
+Added: million of shares available to sell under the Distribution Agreement.
+Added: There were no sales under the Distribution Agreement during the year ended December 31, 2022 .
+Added: During the year ended December 31, 2021, the Company issued 5,540,831 shares of its common stock under the Distribution Agreement and received net proceeds of $ 6.9 million.
+Added: On August 5, 2020, the Company entered into an open market sale agreement (as
+Added: amended from time to time, the “Sale Agreement”) with Jefferies LLC (“Jefferies”), pursuant to which the Company could offer and sell, from time to time, at its option, through or to Jefferies, up to an aggregate of $ 50 million of shares of the Company’s common stock.
+Added: On November 5, 2020 and February 3, 2021, the Company and Jefferies amended the Sale
+Added: Agreement to provide for increases in the aggregate offering amount under the Sale Agreement such that the Company could sell shares having an aggregate offering price of up to $ 105.4 million under the Sale Agreement, as amended.
+Added: The Sale Agreement was terminated on August 31, 2021.
+Added: For the year ended December 31, 2021, the
+Added: 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 March 23, 2022, the Company issued the Hayfin Warrants, whereby affiliates
+Added: 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).
+Added: The Hayfin Warrants was valued at $ 9.6 million, using the Black-Scholes option pricing model assuming an expected term of 7
+Added: years, a volatility of 68.1 %, a dividend yield of 0 % and a risk-free interest rate of 2.36 %.
+Added: During the year ended December 31, 2022, warrants to
+Added: purchase 31,750 shares of common stock that had been issued to a former noteholder of the Company expired.
+Added: At December 31,
+Added: 2022 and 2021, the Company had outstanding warrants to purchase an aggregate of 13,525,148 and 4,528,160 shares, respectively, of common stock, with a weighted average exercise price of $ 1.99 and $ 2.82 per share, respectively, and expiration
+Added: dates ranging between May 2023 and December 2030.
+Added: Equity Incentive Plans
+Added: time to time the Company granted stock options or other equity-based awards under the Company’s Amended and Restated 2014 Omnibus Incentive Compensation Plan (the “2014 Plan”).
The 2014 Plan, as
−Removed: amended, was approved by the Board on March 15, 2017 and by the Company’s stockholders on May 25, 2017.
−Removed: Currently, the maximum number of shares reserved for grant under the 2014 Plan is:
+Added: amended, was approved by the Company’s Board of Directors (the “Board”) on March
+Added: 15, 2017 and by the Company’s stockholders on May 25, 2017.
+Added: The maximum number of shares that were reserved for grant under the 2014 Plan was:
(a) 2,334,940 shares;
1 unchanged sentence
determined by the Board;
−Removed: provided, however, that no more than an aggregate of 10 million shares of common stock may be issued pursuant
−Removed: to incentive stock options intended to qualify under Section 422 of the Internal Revenue Code.
+Added: provided, however, that no more than an aggregate of 10 million shares of common stock may be issued
+Added: pursuant to incentive stock options intended to qualify under Section 422 of the Internal Revenue Code.
As of December 31, 2021, an aggregate of 69,090
5 unchanged sentences
DECEMBER 31, 2022 AND 2021
−Removed: During the years ended December 31, 2021 and 2020, the Company granted options to purchase an aggregate of 1,895,550 and 1,468,412 shares of
−Removed: common stock, respectively, to its directors, employees and certain third-party service providers.
−Removed: The fair value of stock options granted was determined on the date of grant using the Black-Scholes model.
−Removed: The Black-Scholes option valuation
−Removed: model was developed for use in estimating the fair value of publicly traded options, which have no vesting restrictions and are fully transferable.
−Removed: The Company’s employee stock options have characteristics significantly different from those of
−Removed: traded options, and changes in the underlying Black-Scholes assumptions can materially affect the fair value estimate.
−Removed: To determine the risk-free interest rate, the Company utilized the U.S.
−Removed: Treasury yield curve in effect at the time of the grant
−Removed: with a term consistent with the term of the awards granted by the Company.
−Removed: The expected term of the options granted is in accordance with Staff Accounting Bulletins 107 and 110, which is based on the average between vesting terms and contractual
−Removed: The expected dividend yield reflects the Company’s current and expected future policy for dividends on the Company’s common stock.
−Removed: For the years ended December 31, 2021 and 2020, the expected stock price volatility for the Company’s stock
−Removed: options was calculated by examining the historical volatility of the Company’s common stock since the stock became publicly traded in the fourth quarter of 2013.
−Removed: The grant date fair values of stock options awarded during the years ended December 31, 2021 and 2020 were determined using the
−Removed: Black-Scholes option-pricing model with the following assumptions:
+Added: During the years
+Added: 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.
+Added: The fair value of stock options granted was
+Added: 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 restrictions and are fully
+Added: 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 value estimate.
+Added: determine the risk-free interest rate, the Company utilized the U.S.
+Added: 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.
+Added: The expected term of the options granted
+Added: 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 policy for dividends on
+Added: the Company’s common stock.
+Added: 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
+Added: stock became publicly traded in the fourth quarter of 2013.
+Added: 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:
Expected term
3 unchanged sentences
Risk-free interest rate
−Removed: The 2014 Plan provides for the Board or a Committee of the Board (the “Committee”) to grant awards to optionees and to determine the
−Removed: 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.
−Removed: All options granted under the 2014 Plan are intended to be incentive stock options
+Added: On June 21, 2022, the Company’s 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
+Added: 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 optionees and to determine the exercise
+Added: 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 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.
1 unchanged sentence
value of the common stock subject to the stock option agreement.
−Removed: The following table summarizes information about stock options outstanding as of December 31, 2021 and 2020:
+Added: The following
+Added: table summarizes information about stock options outstanding as of December 31, 2022 and 2021:
Exercise Price
8 unchanged sentences
As of December 31, 2022, the Company had $ 2.3
−Removed: million of unrecognized compensation expense related to stock options granted under the Company’s equity incentive plan, which is expected to be recognized over a weighted-average period of 2.4 years.
+Added: million of unrecognized compensation expense related to stock options granted under the Company’s equity incentive plans, which is expected to be recognized over a weighted-average period of 2.2 years.
The weighted average remaining contractual term of stock options outstanding and expected to vest at December 31, 2022 is 6.1 years.
The weighted average remaining contractual term of stock options exercisable at December 31, 2022 is 5.3 years.
−Removed: The following table summarizes additional information regarding outstanding and exercisable options under the stock option plans at December 31, 2021:
+Added: The following table summarizes additional
+Added: information regarding outstanding and exercisable options under the stock option plans at December 31, 2022:
Stock Options Outstanding
12 unchanged sentences
$ 9.37 - $ 10.80
−Removed: $ 9.37 - $ 10.80
During the years ended December 31, 2022 and 2021, the Company granted Restricted Stock Units (“RSUs”) representing an
aggregate of 1,174,266 and 4,384,744
−Removed: shares, respectively, to certain management employees of the Company and, during 2020, to members of its Board of Directors (the “Board”).
−Removed: Except for the RSUs granted under the Company’s retention incentive program discussed below, the RSUs
−Removed: generally vest annually over a 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 shares granted under a retention incentive program implemented by the Company for its executive management and certain employees (see Note 10), whereby the
−Removed: Company issued an aggregate of 2,685,000 time-based RSUs and 1,147,500 milestone-based RSUs.
−Removed: Fifty percent of the
−Removed: time-based RSUs granted under the retention incentive program vest on December 31, 2022, with the remainder vesting in quarterly installments through December 31, 2024.
−Removed: The milestone-based RSUs will vest upon achievement of the applicable
−Removed: milestone, with each milestone required to be achieved on or prior to 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 are
−Removed: consistent with the 2022 operating plan approved by the Board.
−Removed: The Company will periodically assess the probability of vesting for each milestone-based RSU and will adjust compensation expense based on its probability assessment.
−Removed: In connection
−Removed: with the completion of the refinancing of the Company’s senior credit facility on March 23, 2022 (see Note 17), 254,745
−Removed: milestone-based RSUs vested.
−Removed: During the year ended December 31, 2021, 92,750
−Removed: shares vested in connection with grants of RSUs.
−Removed: With respect to these vested RSUs, 27,850 shares valued at approximately $ 62,000 were withheld by the Company to cover employees’ tax liabilities.
−Removed: These shares have been retired by the Company and were no longer
−Removed: outstanding as of December 31, 2021.
−Removed: summary of the Company’s unvested RSU activity and related information is as follows:
+Added: shares, respectively, to certain management employees of the Company and during 2022, to 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
+Added: period of four years for employees and semi-annually over a period of one year for directors.
+Added: The RSUs granted during the year ended December 31, 2021 include 3,832,500
+Added: 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.
+Added: Fifty percent of the time-based RSUs granted under the retention incentive program vested on December 31, 2022, with the remainder vesting in
+Added: quarterly installments through December 31, 2024.
+Added: The milestone-based RSUs vested upon achievement of the applicable milestone, and all of the milestone-based RSUs vested during the
+Added: year ended December 31, 2022.
+Added: 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, 2022 and 2021, 2,727,412
+Added: and 92,750 shares, respectively,
+Added: vested in connection with grants of RSUs.
+Added: With respect to the RSUs vested during the year ended December 31, 2022, 918,851 shares
+Added: valued at approximately $ 2.9 million were withheld by the Company to cover employees’ tax liabilities .
+Added: For the RSUs vested during the year ended December 31, 2021 , 27,850
+Added: shares valued at approximately $ 62,000 were withheld by the Company to cover employees’ tax liabilities.
+Added: These shares have been retired by the
+Added: Company or were otherwise no longer outstanding as of December 31, 2022 .
+Added: A summary of the Company’s unvested RSU activity and related information is as
Average Grant
7 unchanged sentences
DECEMBER 31, 2022 AND 2021
−Removed: As of December 31, 2021, the Company had $ 5.1 million of unrecognized compensation expense related to unvested RSUs granted under the Company’s equity incentive plan, which is expected to be recognized over a
−Removed: weighted-average period of 2.6 years.
−Removed: stock-based compensation expense for all awards granted under the Company’s equity incentive plan for the years ended December 31, 2021 and 2020 was as follows:
+Added: As of December 31, 2022, the Company had $ 3.8 million of unrecognized compensation expense related to unvested RSUs granted
+Added: under the Company’s equity incentive plans, which is expected to be recognized over a weighted-average period of 2.4 years.
+Added: 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:
Research and development
4 unchanged sentences
RELATED PARTY TRANSACTIONS
−Removed: The Company leases an office building and equipment from Areth, LLC (“Areth”) pursuant to an agreement for services effective as of
−Removed: January 1, 2016, as amended from time to time.
−Removed: Effective October 1, 2017, monthly rent on this facility was reduced to $ 10,000 .
−Removed: September 27, 2018, the agreement was amended to extend the term of the agreement through September 30, 2019.
−Removed: On November 7, 2019, an additional amendment was entered into between Areth and the Company to extend the term of this agreement through
−Removed: September 30, 2020, and to provide for automatic one-year renewals unless ADMA gives written notice of termination to Areth 60 days prior to the end of the term.
−Removed: The Company did not provide such written notice to Areth as of July 31, 2021.
−Removed: Rent expense for the years ended
−Removed: December 31, 2021 and 2020 amounted to $ 0.1 million.
+Added: The Company leases an office building and equipment from Areth, LLC (“Areth”) pursuant to an agreement for services effective as of January 1, 2016, as amended from time
+Added: to time , and pays monthly rent on this facility in the amount of $ 10,000 .
+Added: On October 18, 2022 , the Company amended the agreement to extend its term to December 31, 2026 , with automatic successive one-year
+Added: renewals thereafter.
+Added: Either party may terminate the agreement by providing the other party with one year ’s prior written notice .
+Added: Rent expense for the years ended December 31, 2022 and 2021 amounted to $ 0.1
Areth is a company controlled by Dr.
−Removed: Grossman, the Vice Chairman of
−Removed: the Company’s Board of Directors, and Adam S.
+Added: Grossman, the Vice Chairman of the Board, and Adam S.
Grossman, the Company’s President and Chief Executive Officer.
−Removed: The Company also reimburses Areth for office, warehousing and building related (common area) expenses, equipment and certain other
−Removed: operational expenses, which were not material to the consolidated financial statements for the years ended December 31, 2021 and 2020.
+Added: The Company also reimburses Areth for office, warehousing and building
+Added: 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, 2022 and 2021.
During the years ended December 31, 2022 and 2021, the Company purchased certain specialized medical equipment and services related to the
Company’s plasma collection centers, as well as personal protective equipment, from GenesisBPS and its affiliates (“Genesis”) in the amount of $ 0.2
−Removed: million and $ 0.1 million, respectively.
Genesis is owned by Dr.
Grossman and Adam Grossman.
−Removed: See Notes 7 and 17 for a discussion of the Company’s credit facility and related transactions with Perceptive, a holder of more
+Added: See Note 7 for a discussion of the Company’s prior credit facility and related transactions with Perceptive, a holder of more
than 5 % of the Company’s common stock.
1 unchanged sentence
James Mond, the Company’s former Chief Scientific and Medical Officer, the Company recognized an expense and corresponding liability in the amount of $ 0.8 million for payments to be made under a separation and transition agreement with Dr.
−Removed: Such payments are to be made in scheduled installments
−Removed: over a period of 10 months.
−Removed: connection with the 2021 public offering of the Company’s common stock (see Note 8) on October 25, 2021:
+Added: These payments were made in scheduled installments over
+Added: a period of 10 months.
+Added: connection with the 2022 public offering of the Company’s common stock (see Note 8) on December 9, 2022:
Grossman purchased 14,983
−Removed: shares of common stock directly and 250,000 shares of common stock indirectly through an entity he controls, (ii) Dr.
−Removed: purchased 100,000 shares of common stock, (iii) Dr.
−Removed: Young Kwon, a member of the Company’s Board of Directors, 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 share.
+Added: shares of common stock directly and 14,982 shares of common stock indirectly through an entity he controls, and (ii) Brian Lenz, the
+Added: Company’s Executive Vice President and Chief Financial Officer, purchased 6,993 shares of common stock, all at the public offering
+Added: price of $ 2.86 per share.
In connection with
−Removed: the 2020 public offering of the Company’s common stock (see Note 8) on February 11, 2020:
−Removed: (i) Perceptive Advisors, a principal stockholder of ADMA, purchased 4,563,700 shares of common stock through one of its affiliates, (ii) Dr.
−Removed: Grossman purchased 22,857
−Removed: shares of common stock directly and 22,857 shares indirectly through an entity he controls, (iii) Lawrence P.
−Removed: Guiheen, a director of
−Removed: the Company, purchased 20,000 shares of common stock, (iv) Mr.
−Removed: Grossman purchased 28,571 shares of common stock directly and 57,143 shares
−Removed: indirectly through an entity he controls, (v) Mr.
−Removed: Lenz purchased 7,142 shares of common stock, and (vi) Dr.
−Removed: Mond purchased 4,285 shares of common stock, all at the public offering price of $ 3.50 per share.
+Added: the 2021 public offering of the Company’s common stock (see Note 8) on October 25, 2021:
+Added: Grossman purchased 100,000 shares of
+Added: common stock directly and 250,000 shares of common stock indirectly
+Added: through an entity he controls, (ii) Dr.
+Added: Grossman purchased 100,000 shares of common stock, (iii) Dr.
+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 per
ADMA BIOLOGICS, INC.
8 unchanged sentences
COVID-19 Pandemic
−Removed: The Company continues to monitor the ongoing developments related to the COVID-19 pandemic, including the emergence of the Delta
−Removed: and Omicron 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 materials
−Removed: 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 been
−Removed: performed by contract laboratories outside the United States.
−Removed: Due to a combination of previous state and local “shelter-in-place” orders, as well as government stimulus packages,
−Removed: persisting social distancing measures and varying roll-outs of vaccinations by state, the Company has experienced lower than normal donor collections at its FDA approved plasma collection centers.
−Removed: The Company was also subject to delays in
−Removed: 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 distribution of its
−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 result, the Company has
−Removed: elected to carry more raw materials inventory than it has in the past.
−Removed: The COVID-19 pandemic has also impacted, to a certain degree, the Company’s customer engagement initiatives, whereby ADMA’s sales and medical affairs field personnel have
−Removed: 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 ability to communicate
−Removed: with potential customers.
−Removed: The Company has implemented a comprehensive suite of virtual engagement initiatives;
−Removed: however, clinician engagement has been reduced due to rapidly evolving COVID-19 priorities at U.S.
−Removed: medical centers.
+Added: The Company continues to monitor the ongoing developments related to the COVID-19 pandemic, including the emergence of the
+Added: 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
+Added: 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.
+Added: A substantial portion of such testing has historically
+Added: been performed by contract laboratories outside the United States.
+Added: Due to a combination of previously mandated state and local “shelter-in-place” orders, as well as government stimulus
+Added: 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.
+Added: The Company was also subject
+Added: 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
+Added: distribution of its products.
+Added: 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
+Added: result, the Company has elected to carry more raw materials inventory than it has in the past.
+Added: The COVID-19 pandemic previously impacted, to a certain degree, the Company’s customer engagement initiatives, whereby ADMA’s sales and medical
+Added: 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
+Added: ability to communicate with potential customers.
The pandemic could also impact the Company’s ability to interact with the FDA or other regulatory authorities and may result
in delays in the conduct of inspections or review of pending applications or submissions.
−Removed: Although the Company received several FDA approvals and two
−Removed: FDA inspections 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 other regulatory submissions or applications that may be impacted by restrictions
−Removed: related to COVID-19.
−Removed: During the years ended December 31, 2021 and 2020, revenue attributable to international customers was approximately 13 % of the 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
−Removed: COVID-19 pandemic in locations outside the United States.
+Added: Although the Company received FDA approvals for four
+Added: of its plasma collection centers during the year ended December 31, 2022 and received several FDA approvals and two FDA inspections
+Added: 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
+Added: During the years ended December 31, 2022 and 2021, revenue attributable to international customers was approximately 5 % and 13 %, respectively, of the
+Added: Company’s total revenues.
+Added: 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.
Notwithstanding the foregoing, the COVID-19 pandemic to date has not had a material impact on the Company’s financial condition or results
2 unchanged sentences
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 pandemic or its long-term effects on, among other things, the global, national or local economies, the capital and credit markets or the Company’s workforce, customers or our
−Removed: suppliers, at this time the Company is unable to predict whether COVID-19 will have a material adverse impact on the Company’s business, financial condition, liquidity and results of operations.
+Added: 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
+Added: 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
ADMA BIOLOGICS, INC.
2 unchanged sentences
DECEMBER 31, 2022 AND 2021
−Removed: Vendor and Licensor Commitments
+Added: Vendor Commitments
Pursuant to the terms of a plasma purchase agreement with BPC dated as of November 17, 2011 (the “2011 Plasma Purchase Agreement”), the
11 unchanged sentences
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 (see Note 16).
−Removed: Pursuant to this amendment, until January 1, 2022, the Company may purchase RSV plasma from Grifols from the two 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 plasma purchased from these two
−Removed: plasma collection centers will be subject to the pricing terms in effect for RSV plasma purchased from other plasma collection centers owned by Grifols.
+Added: antibodies to RSV from Grifols.
+Added: Pursuant to this amendment, until January 1, 2022, the Company could purchase RSV plasma from Grifols from the two
+Added: 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).
+Added: Effective January 1, 2022, RSV
+Added: plasma purchased from these two plasma collection centers are subject to the pricing terms in effect for RSV plasma purchased from
+Added: other plasma collection centers owned by Grifols.
On June 6, 2017, the Company and BPC entered into a Plasma Supply Agreement pursuant to which BPC supplies, on an exclusive basis subject
23 unchanged sentences
DECEMBER 31, 2022 AND 2021
−Removed: Effective as of May 12, 2021, the Company and Grifols amended the foregoing
−Removed: 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: In order to maintain a reliable supply of raw material plasma
−Removed: thereafter, the Company has executed additional agreements with multiple third-party suppliers of NSP to supplement the 2017 Plasma Purchase Agreement.
−Removed: The Company has also increased its number of planned plasma collection center buildouts such
−Removed: that the Company expects to have 10 FDA-approved plasma collection centers in operation by the end of 2023, while also continuing to
−Removed: increase its plasma collection capabilities at its ADMA BioCenters plasma collection centers business segment.
+Added: Effective as of May 12, 2021, the Company and Grifols
+Added: 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.
+Added: The 2017 Plasma Purchase Agreement expired on
+Added: December 31, 2022 and was not renewed.
+Added: 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.
+Added: The Company has also increased its
+Added: number of planned plasma collection center buildouts such that the Company expects to have ten FDA-approved plasma collection
+Added: 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.
Post-Marketing Commitments
−Removed: In connection with the approval of the BLA for BIVIGAM, on December 19, 2012 Biotest committed to perform two additional post-marketing
−Removed: studies, a pediatric study to evaluate the efficacy and safety of BIVIGAM in children and adolescents, and a post-authorization safety study to further assess the potential risk of hypotension and hepatic and renal impairment in BIVIGAM-treated
−Removed: patients with primary humoral immunodeficiency.
−Removed: These studies are still pending completion.
−Removed: ADMA has assumed the remaining obligations, and the costs of the studies will be expensed as incurred as research and development expenses.
−Removed: currently expects to incur expenses of approximately $ 3.0 million to $ 4.0 million to complete these studies, with both studies to be completed by June of 2023.
−Removed: In connection with the FDA’s approval of ASCENIV on April 1, 2019, the Company is required to perform a pediatric study to evaluate the
+Added: In connection with the FDA approval of the BLA for BIVIGAM on December 19, 2012, Biotest committed to perform two additional
+Added: post-marketing studies, a pediatric study to evaluate the efficacy and safety of BIVIGAM in children and adolescents, and a post-authorization safety study to further assess the potential risk of hypotension and hepatic and renal impairment in
+Added: BIVIGAM-treated patients with primary humoral immunodeficiency.
+Added: The Pediatric study for BIVIGAM has been completed, and the safety study is still pending completion.
+Added: ADMA has assumed the remaining obligations, and the costs of the studies will be
+Added: expensed as incurred as research and development expenses.
+Added: 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.
+Added: The Company currently expects to incur expenses of
+Added: approximately $ 2.0 million to complete these studies, with both studies anticipated to be completed by June of 2023.
+Added: 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: The Company expects to incur expenses of approximately $ 2 million to
−Removed: complete this study, which is required to be completed by June of 2023.
+Added: 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.
+Added: The Company expects
+Added: to incur expenses of approximately $ 1.5 million to complete this study, which is required to be completed by June of 2023.
Employment Contracts
2 unchanged sentences
Other Commitments
−Removed: On September 28, 2021, following the approval of the Company’s Board of Directors upon recommendation of the Compensation Committee of the Board of Directors, and in consultation with an independent compensation consultant,
−Removed: the Company implemented a retention incentive program, consisting of cash payments and awards of RSUs (see Note 8), to the Company’s management, including Mr.
+Added: On September 28, 2021, following the approval of the Board upon recommendation of the Compensation Committee of the Board, and in consultation with an independent
+Added: compensation consultant, the Company implemented a retention incentive program, consisting of cash payments and awards of RSUs (see Note 8), to the Company’s management, including Mr.
Grossman and Mr.
Lenz, and to certain other employees.
−Removed: The purpose of the retention
−Removed: program is 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.
−Removed: The retention awards were granted considering the nationwide labor shortages and the
−Removed: increased employee turnover rates that the Company, its pharmaceutical peers and other companies outside of the Company’s industry have reported experiencing.
−Removed: The cash portion of the retention program consists of two tranches.
−Removed: The first tranche was paid to employees on
−Removed: September 30, 2021 in the amount of $ 1.3 million, and the second tranche aggregating to approximately $ 1.3 million will be paid on June 15, 2022.
−Removed: Based on the terms of the retention agreements the Company entered into with each applicable executive and
−Removed: employee, $ 0.8 million of the first tranche is being recognized over the retention service period, which ends on December 31, 2022,
−Removed: with the remainder having been recognized as expense on September 30, 2021.
−Removed: The second tranche will be recognized as compensation expense over a 15 -month
−Removed: period from October 1, 2021 through December 31, 2022.
−Removed: In the normal course of business, the Company enters into contracts that contain a variety of indemnifications with its employees,
−Removed: licensors, suppliers and service providers.
+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 ongoing COVID -19 pandemic and the competitive work environment in which the Company operates as an FDA regulated manufacturer of specialized biologic therapies.
+Added: The retention awards were granted considering the nationwide labor
+Added: shortages and the increased employee turnover rates that the Company, its pharmaceutical peers and other companies outside of the Company’s industry have reported experiencing.
+Added: The cash portion of the retention program consisted of two tranches.
+Added: The first tranche was paid to employees on September 30, 2021 in the amount of $ 1.3
+Added: million, and the second tranche aggregating to approximately $ 1.3 million was paid on June 15, 2022.
+Added: Based on the terms of the
+Added: retention agreements the Company entered into with each applicable executive and employee, approximately $ 0.8 million of each tranche
+Added: was recognized over the retention service period, which began on October 1, 2021 and ended on December 31, 2022, with the remainder having been recognized as expense when paid.
+Added: In the normal course of business, the Company enters into contracts that contain a variety of indemnifications with its employees, licensors, suppliers and service
Further, the Company indemnifies its directors and officers who are, or were, serving at the Company’s request in such capacities.
−Removed: The Company’s maximum exposure under these arrangements is unknown as
−Removed: of December 31, 2021.
−Removed: The Company does not anticipate recognizing any significant losses relating to these arrangements.
+Added: The Company’s maximum exposure under these arrangements is unknown as of December 31, 2022.
+Added: Company does not anticipate recognizing any significant losses relating to these arrangements.
ADMA BIOLOGICS, INC.
11 unchanged sentences
Decrease in federal net operating loss
+Added: 162(m) disallowance
Benefit for income taxes
11 unchanged sentences
As of December 31, 2022, the Company had federal and state (post-apportioned
−Removed: basis) net operating losses (“NOLs”) of $ 299.9 million and $ 185.0 million, respectively.
+Added: 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.
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
1 unchanged sentence
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: particular, Section 382 of the Internal Revenue Code 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 has taxable
−Removed: 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 stock that
−Removed: 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, 2021, the Company performed an analysis of limitations imposed by Section 382
−Removed: of the Internal Revenue Code and as a result has written 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 are 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 is 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: 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.
+Added: If the Company is limited in its ability to use its NOLs in future years in which it
+Added: has taxable income, then the Company will pay more taxes than if it were otherwise able to fully 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
+Added: 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.
+Added: As of December 31, 2022, the Company performed a preliminary analysis of limitations
+Added: 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.
+Added: As of December 31, 2021, the Company performed an analysis of limitations imposed
+Added: 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.
+Added: 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.
A valuation allowance, if needed, reduces deferred tax assets to the amount expected to be realized.
23 unchanged sentences
LEASE OBLIGATIONS
−Removed: The Company leases certain properties and equipment for its ADMA BioCenters subsidiary and certain equipment for its ADMA BioManufacturing
−Removed: subsidiary, which leases provide the right to use the underlying assets and require lease payments through the respective lease terms which expire at various dates through 2033.
−Removed: The Company’s lease agreements do not contain any material residual
−Removed: value guarantees or material restrictive covenants.
−Removed: The Company determines if an arrangement is an operating lease
−Removed: at inception.
+Added: The Company leases certain properties and equipment for its ADMA BioCenters and ADMA BioManufacturing subsidiaries, which leases provide
+Added: the right to use the underlying assets and require lease payments through the respective lease terms which expire at various dates through 2033.
+Added: The Company’s lease agreements do not contain any material residual value guarantees or material
+Added: restrictive covenants.
+Added: The Company determines if an arrangement is an operating lease at inception.
Leases with an initial term of 12 months or less are not recorded on the balance sheet.
−Removed: 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
−Removed: liabilities representing the obligation to make lease payments arising from the lease.
−Removed: 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
−Removed: include options to extend or terminate the lease when they are reasonably certain to be exercised.
+Added: 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.
+Added: 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.
The present value of the lease payments is determined using the Company’s incremental borrowing rate as of the lease commencement date.
−Removed: lease liabilities recognized during the years ended December 31, 2021 and 2020, the Company used a discount rate of 13 % to determine
−Removed: 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 administrative expenses.
+Added: For the lease liabilities recognized during the years ended December 31, 2022 and 2021, the Company used
+Added: discount rates of 13 % to 14 %
+Added: 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 lease term and is reflected in Plasma center operating expenses and Selling, general and
+Added: administrative expenses in the accompanying consolidated statements of operations.
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 paid on these leases for the years ended December 31, 2021 and 2020 was $ 1.1 million and $ 0.5 million,
−Removed: respectively.
+Added: Aggregate cash
+Added: paid on these leases for the years ended December 31, 2022 and 2021 was $ 1.8 million and $ 1.4 million, respectively.
ADMA BIOLOGICS, INC.
2 unchanged sentences
DECEMBER 31, 2022 AND 2021
−Removed: During the year ended December 31, 2021, the Company recognized
−Removed: additional right-to-use assets and corresponding lease liabilities of $ 3.6 million in connection with four new property leases where the Company has opened or intends to open additional plasma collection facilities.
−Removed: Including a finance lease the
−Removed: Company entered into in June 2018, the Company has aggregate lease liabilities of $ 8.1 million and $ 4.7 million as of December 31, 2021 and 2020, respectively, which are comprised primarily of the leases for the Company’s plasma collection
+Added: During the year ended December
+Added: 31, 2022, the Company recognized additional right-to-use assets and corresponding lease liabilities aggregating to approximately $ 4.0
+Added: million in connection with two new property leases where the Company has opened additional plasma collection facilities, a
+Added: 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: During the year ended December 31, 2021, the Company recognized additional
+Added: 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.
+Added: Including a finance lease the Company entered into
+Added: 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.
Company’s operating leases have a weighted average remaining term of 8.4 years.
6 unchanged sentences
Balance at December 31, 2022
−Removed: On June 11, 2021, t he Company entered into an additional property lease that the Company intends to use to store certain
−Removed: inventory for its ADMA BioManufacturing business segment.
−Removed: The Company has not taken possession of this leased property and its lease commencement date has not been determined.
−Removed: With the exception of a security deposit and six months’ rent totaling $ 0.3 million, no payments have been
−Removed: made under this lease.
−Removed: The initial term of the lease is for 90 months with monthly rental payments varying between approximately $ 14,000 and $ 24,000 , including common
−Removed: area maintenance charges.
−Removed: On January 22, 2022, the Company entered into an additional property lease for its ninth plasma collection
−Removed: The Company has not taken possession of this leased property and its
−Removed: lease commencement date has not been determined.
−Removed: With the exception of a security deposit and an initial month’s rent totaling approximately $ 44,000 , no payments have been made under this lease.
−Removed: The initial term of the lease is for 126 months with monthly rental payments varying between approximately $ 18,000
−Removed: and $ 25,000 , including common area maintenance charges.
−Removed: The Company is engaged in the manufacture, marketing and development of specialty plasma-derived biologics.
−Removed: The Company’s ADMA
−Removed: BioManufacturing 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 in various stages of development as of December 31, 2021, six of which are operational and collecting plasma, and five of which hold an approved license with
−Removed: the FDA (and of which one facility has received approvals from the Korean Ministry of Food and Drug Safety as well as FDA approval to
−Removed: implement a Hepatitis B immunization program).
+Added: 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
+Added: The current monthly payment for this lease is approximately $ 10,000 .
+Added: The Company intends to renew the lease for an additional
+Added: five years in accordance with the terms of the lease, however no renewal agreement has been finalized.
+Added: The Company is engaged in manufacturing, marketing and developing specialty plasma-derived biologics.
+Added: The Company’s ADMA BioManufacturing
+Added: 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, 2022, nine of which were
+Added: 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: immunization program).
The Corporate segment includes general and administrative overhead expenses.
−Removed: The Company defines its segments as those business units whose operating results are regularly reviewed by the chief
−Removed: operating decision maker (“CODM”) to analyze performance and allocate resources.
+Added: The Company defines its segments as those business units whose operating results are regularly reviewed by the chief operating decision maker
+Added: (“CODM”) to analyze performance and allocate resources.
The Company’s CODM is its President and Chief Executive Officer.
−Removed: Summarized financial information concerning reportable segments is shown in the following
+Added: Summarized financial information concerning reportable segments is shown in the following tables:
ADMA BIOLOGICS, INC.
6 unchanged sentences
Cost of product revenue
−Removed: Loss from operations
+Added: Income (loss) from operations
Interest and other expense, net
+Added: Loss on extinguishment of debt
+Added: Net income (loss)
Capital expenditures
6 unchanged sentences
Interest and other expense, net
−Removed: Gain on extinguishment of debt
Capital expenditures
21 unchanged sentences
accounts receivable.
−Removed: At December 31, 2021, three customers accounted for approximately 94 % 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.
At December 31, 2021, three
customers accounted for approximately 94 % of the Company’s consolidated accounts receivable.
−Removed: For the year ended December 31, 2021, four
+Added: For the year ended December 31, 2022, two
customers accounted for approximately 74 % of the Company’s consolidated revenues.
−Removed: For the year ended December 31, 2020, three customers represented an aggregate of 82 %
−Removed: of the Company’s consolidated revenues.
−Removed: The Company purchases substantially all of its raw material plasma from Grifols.
−Removed: For the year ended December 31, 2021, plasma purchases
−Removed: from Grifols were approximately $ 42.0 million, or 69 % of the Company’s total inventory purchases.
−Removed: For the year ended December 31, 2020, plasma purchases from Grifols were approximately $ 25.0 million, or 68 % of the Company’s total inventory
−Removed: Net revenues according
−Removed: to geographic area, based on the location of where the product is shipped, is as follows:
+Added: For the year ended December 31, 2021, four customers accounted for approximately 81 % of the Company’s consolidated revenues.
+Added: During the years ended December 31, 2022 and 2021, plasma purchases from Grifols totaled approximately $ 47.7 million and $ 42.0 million,
+Added: respectively, or approximately 65 % and 69 %, respectively, of the Company’s total inventory purchases.
+Added: Net revenues according to geographic
+Added: area, based on the location of where the product is shipped, is as follows:
Year Ended December 31,
3 unchanged sentences
SUBSEQUENT EVENTS
−Removed: Refinancing of Senior Credit Facility
−Removed: On March 23, 2022, (the “Hayfin Closing Date”) the Company and all of its subsidiaries entered into a Credit and Guaranty Agreement (the
−Removed: “Hayfin Credit Agreement”) with Hayfin Services LLP (“Hayfin”).
−Removed: T he 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 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
−Removed: make the Hayfin Delayed Draw Loan expires on March 22, 2023 and is subject to the satisfaction of certain conditions, including, but
−Removed: not limited to, the Company’s meeting certain 12-month revenue targets as set forth in the Hayfin Credit Agreement.
−Removed: The Hayfin Credit Facility has a maturity date of March 23, 2027 (the “Hayfin Maturity Date”), subject to acceleration pursuant to the Hayfin Credit Agreement, including upon an Event of Default (as defined in the Hayfin
−Removed: Credit Agreement) .
−Removed: On the Hayfin Closing Date, the Company used $ 100.0
−Removed: million of the Hayfin Closing Date Loan to terminate and pay in full all of the outstanding obligations under the Perceptive Credit Facility (see Note 7).
−Removed: The Company also used $ 2.0 million of the Hayfin Closing Date Loan proceeds to pay a redemption premium to Perceptive and used approximately $ 0.3 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 Hayfin Credit
−Removed: In connection with the repayment of the Perceptive Loans, the Company will record a loss on extinguishment of debt in the approximate amount of $ 6.7 million, consisting of the write-off of unamortized discount related to the Perceptive Loans and the redemption premium paid to Perceptive.
−Removed: ADMA BIOLOGICS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: DECEMBER 31, 2021 AND 2020
−Removed: Borrowings under the Hayfin Credit Agreement will bear interest, at the Company’s election, at either (a) a base rate (equal to the
−Removed: 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 funds rate in effect on such day plus 0.50 % and (iii) adjusted Term Secured Overnight Financing Rate (“SOFR”) for a one-month
−Removed: tenor in effect on such day plus 1.00 %) 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 was 10.75 %.
−Removed: The Company will also pay “in kind” a portion of the interest on the Hayfin Loans for each monthly or quarterly interest period in an amount
−Removed: equal to 2.5 % per annum, which will be added to the principal amount of the outstanding debt under the Hayfin Credit Facility.
−Removed: On the Hayfin Maturity Date, the Company will pay Hayfin the entire outstanding principal amount underlying the Hayfin Loans and any
−Removed: accrued and unpaid interest thereon, as well as an exit fee of 1.0 % of the outstanding principal amount being paid.
−Removed: Hayfin Maturity Date, there will be no scheduled principal payments on the Hayfin Loans.
−Removed: The Company may prepay outstanding principal
−Removed: on the Hayfin Loans at any time and from time to time upon five business days’ prior written notice, subject to the payment to Hayfin
−Removed: of, (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 prepaid
−Removed: 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 Date.
−Removed: In addition, for any prepayments of
−Removed: principal or payment of principal on the Hayfin Maturity Date, the Company is required to pay an exit fee of 1.0 % of the amount of
−Removed: principal being paid.
−Removed: All of the Company’s obligations under the Hayfin Credit Agreement are secured by a first-priority lien and security interest in
−Removed: substantially all of the Company’s tangible and intangible assets, including intellectual property and all of the equity interests in the Company’s subsidiaries.
−Removed: The Hayfin Credit Agreement contains certain representations and warranties,
−Removed: 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 and its subsidiaries to, among other things and subject to certain
−Removed: exceptions contained in the Hayfin Credit Agreement, incur new indebtedness;
−Removed: create liens on assets;
−Removed: engage in certain fundamental corporate changes, such as mergers or acquisitions, or changes to the Company’s or its subsidiaries’ business
−Removed: make certain Investments or Restricted Payments (each as defined in the Hayfin Credit Agreement);
−Removed: change its fiscal year;
−Removed: pay dividends;
−Removed: repay other certain indebtedness;
−Removed: engage in certain affiliate transactions;
−Removed: or enter into, amend
−Removed: or terminate any 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
−Removed: minimum cash balance of $ 6.0 million;
−Removed: and (ii) as of the last day of each fiscal quarter commencing with the fiscal quarter ending June
−Removed: 30, 2022, report IVIG product and related revenues for the trailing 12-month period that exceed the amounts set forth in the Hayfin Credit Agreement, which range from $ 75.0 million for the fiscal quarter ending June 30, 2022 to $ 250.0 million for the fiscal quarter
−Removed: ending December 31, 2026.
−Removed: ADMA BIOLOGICS, INC.
−Removed: AND SUBSIDIARIES
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: DECEMBER 31, 2021 AND 2020
−Removed: As consideration for the Hayfin Credit Agreement, the Company issued to various entities affiliated with Hayfin, on the Hayfin Closing
−Removed: Date, warrants to purchase 9,103,047 shares of the Company’s common stock (the “Hayfin Warrants”).
−Removed: The Hayfin Warrants have an
−Removed: exercise price equal to $ 1.6478 per share, which is equal to the trailing 30 -day Volume Weighted-average Price of the Company’s common stock on the business day immediately prior to the Hayfin Closing Date (the “Closing Date Exercise Price”).
−Removed: Hayfin Warrants were valued by the Company at approximately $ 9.6 million as of the Hayfin Closing Date and have an expiration date of March 23, 2029 .
−Removed: As a result of the fees paid to Hayfin and the value
−Removed: of the Hayfin Warrants, the Company recognized an aggregate discount on the Hayfin Loans in the amount of $ 13.2 million.
−Removed: 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.
−Removed: Based on the fair value of the Hayfin Warrants and the aggregate
−Removed: amount of fees and expenses associated with obtaining the Hayfin Credit Facility, the effective interest rate on the Hayfin Loans as of March 23, 2022 was approximately 12.9 % .
+Added: On March 22, 2023, the Company and Hayfin entered into an amendment to the Hayfin Credit Agreement whereby the lenders’ obligation to
+Added: make the Hayfin Delayed Draw Loan (see Note 7) was extended to June 30, 2023.
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.