Item 9A. Controls and Procedures
Item 9A.
Controls and Procedures
Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2022. The term “disclosure
controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that
it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures
designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal
financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any set of controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of
achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of December 31, 2022,
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.
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Management’s Annual Report on Internal Control Over Financial Reporting
The Management of ADMA Biologics, Inc. (the “Company”) is responsible for establishing and maintaining adequate internal control over financial reporting for the Company. Internal control over financial reporting is
defined in Rule 13a-15(f) or 15d-15(f) promulgated under the Exchange Act, as amended, as a process designed by, or under the supervision of, the Company’s principal executive and principal financial officers and effected by the Company’s board
of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with accounting principles generally
accepted in the United States of America (“U.S. GAAP”) and includes those policies and procedures that: (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the
assets of the Company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with U.S. GAAP, and that receipts and expenditures of our company are being made only
in accordance with authorizations of management and directors of the Company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the Company’s assets that could have
a material effect on the financial statements.
Internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements prepared for external purposes in
accordance with U.S. GAAP. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that
controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Management, with the participation of the Company’s Chief Executive Officer and Chief Financial Officer, assessed the effectiveness of its internal control over financial reporting as of December 31, 2022. In making
this assessment, management used the criteria set forth in the Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on its assessment, management concluded that the
Company’s internal control over financial reporting was effective as of December 31, 2022 based on those criteria.
As a Smaller Reporting Company, the Company is not required to include in this Annual Report on Form 10-K a report on the effectiveness of its internal control over financial reporting by the Company’s independent
registered public accounting firm.
Changes in Internal Control Over Financial Reporting
There has been no change in our internal control over financial reporting during the quarter ended December 31, 2022 that has materially affected, or is reasonably likely to materially affect, our internal control
over financial reporting.
Item 9B.
Other Information
None.
Item 9C.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
None.
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PART III
Item 10.
Directors, Executive Officers and Corporate Governance
Information required to be disclosed by this Item with respect to our executive officers is incorporated into this Annual Report on Form 10-K by reference from the section entitled “Executive Officers and Director
and Officer Compensation: Executive Officers” contained in our definitive proxy statement for our 2023 annual meeting of stockholders, which we intend to file within 120 days of the end of our fiscal year ended December 31, 2022.
Information required to be disclosed by this Item about our Board of Directors (the “Board”) is incorporated into this Annual Report on Form 10-K by reference from the section entitled “Proposal
No. 1: Election of Directors” contained in our definitive proxy statement for our 2023 annual meeting of stockholders, which we intend to file within 120 days of the end of our fiscal year ended December 31, 2022.
To the extent necessary, information required to be disclosed by this Item about the Section 16(a) compliance of our directors and executive officers is incorporated into this Annual Report on
Form 10-K, as applicable, by reference from the section entitled “Delinquent Section 16(a) Reports” contained in our definitive proxy statement for our 2023 annual meeting of stockholders, which we intend to file within 120 days of the end of our
fiscal year ended December 31, 2022.
Information required to be disclosed by this Item about our Board, the Audit Committee of our Board, our audit committee financial expert, our Code of Ethics and Business Conduct Standards, and other corporate
governance matters is incorporated into this Annual Report on Form 10-K by reference from the section entitled “Corporate Governance” contained in our definitive proxy statement for our 2023 annual meeting of stockholders, which we intend to file
within 120 days of the end of our fiscal year ended December 31, 2022.
The text of our Code of Ethics and Business Conduct Standards, which applies to our directors and employees (including our principal executive officer, principal financial officer, principal accounting officer or
controller and persons performing similar functions), is posted in the “Corporate Governance” section of the Investors section of our website, www.admabiologics.com. A copy of the Code of Ethics and Business Conduct Standards can be obtained free
of charge on our website. We intend to disclose on our website any amendments to, or waivers from, our Code of Ethics and Business Conduct Standards that are required to be disclosed pursuant to the rules of the SEC and The Nasdaq Stock Market.
The information presented on our website is not a part of this Annual Report on Form 10-K and the reference to our website is intended to be an inactive textual reference only.
Item 11.
Executive Compensation
Information required to be disclosed by this Item is incorporated into this Annual Report on Form 10-K by reference from the section entitled “Executive Officers and Director and Officer Compensation” contained in
our definitive proxy statement for our 2023 annual meeting of stockholders, which we intend to file within 120 days of the end of our fiscal year ended December 31, 2022.
Item 12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Information required to be disclosed by this Item is incorporated into this Annual Report on Form 10-K by reference from the sections entitled “Security Ownership of Certain Beneficial Owners and Management and
Related Stockholder Matters” contained in our definitive proxy statement for our 2023 annual meeting of stockholders, which we intend to file within 120 days of the end of our fiscal year ended December 31, 2022.
Item 13.
Certain Relationships and Related Transactions, and Director Independence
The information required to be disclosed by this Item is incorporated in this Annual Report on Form 10-K by reference from the section entitled “Certain Relationships and Related Transactions, and Director
Independence” contained in our definitive proxy statement for our 2023 annual meeting of stockholders, which we intend to file within 120 days of the end of our fiscal year ended December 31, 2022.
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Item 14.
Principal Accounting Fees and Services
The information required to be disclosed by this Item is incorporated into this Annual Report on Form 10-K by reference from the section entitled “Audit and Other Fees” contained in our definitive proxy statement for
our 2023 annual meeting of stockholders, which we intend to file within 120 days of the end of our fiscal year ended December 31, 2022.
PART IV
Item 15.
Exhibits, Financial Statement Schedules
Financial Statement Schedules
(a) The following documents are filed as part of this Annual Report on Form 10-K:
(1) Consolidated Financial Statements.
Page
Report of Independent Registered Public Accounting Firm
F-2
Consolidated Balance Sheets as of December 31, 2022 and 2021
F-4
Consolidated Statements of Operations for the years ended December 31, 2022 and 2021
F-5
Consolidated Statements of Changes in Stockholders’ Equity for the years ended December 31, 2022 and 2021
F-6
Consolidated Statements of Cash Flows for the years ended December 31, 2022 and 2021
F-7
Notes to Consolidated Financial Statements
F-8
(2) Financial Statement Schedules.
Required information is included in the footnotes to the financial statements.
(3) Index to Exhibits.
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INDEX TO EXHIBITS
Exhibit
No.
Description
2.1
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
reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K, filed with the SEC on January 23, 2017).
3.1
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).
3.1.1
Certificate of Amendment of the Second Amended and Restated Certificate of Incorporation of ADMA Biologics, Inc., dated as of May 27, 2021 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on
May 28, 2021).
3.2
Amended and Restated Bylaws (incorporated herein by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K, filed with the SEC on October 7, 2016).
3.3
Certificate of Designation of Series A Junior Participating Preferred Stock of ADMA Biologics, Inc. (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).
4.1
Specimen Common Stock Certificate (incorporated herein by reference to Exhibit 4.1 to Amendment No. 1 to the Company’s Current Report on Form 8-K/A, filed with the SEC on March 29, 2012).
4.2
Warrant Agreement, dated December 21, 2012, issued by the Company to Hercules Technology Growth Capital, Inc. (incorporated herein by reference to Exhibit 4.3 to the Company’s Registration Statement on Form S-1, filed with the SEC on
February 11, 2013).
4.3
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).
4.4
Warrant to Purchase Stock, dated October 10, 2017, issued by the Company to Marathon Healthcare Finance Fund, L.P. (incorporated herein by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K, filed with the SEC on
October 11, 2017).
4.5
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
12, 2019).
4.6
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).
4.7
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,
filed with the SEC on March 24, 2021).
4.8
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).
4.9
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).
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4.10
Note, dated December 8, 2020, issued by the Company to Perceptive Credit Holdings II, L.P. (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).
4.11
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).
4.12
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
10-K, filed with the SEC on March 24, 2022).
10.1†
2007 Employee Stock Option Plan, as amended by Amendment No. 3 (incorporated herein by reference to Exhibit A to the Information Statement on Schedule 14C, filed with the SEC on October 29, 2012).
10.2†
Amended and Restated ADMA Biologics, Inc. 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).
10.3†
Amended and Restated Employment Agreement, dated January 29, 2019, by and between ADMA Biologics, Inc. and Adam Grossman (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed with the SEC
on January 29, 2019).
10.3.1†
Amendment to Employment Agreement, dated as of September 29, 2021, by and between ADMA Biologics, Inc. 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
October 1, 2021).
10.4†
Amended and Restated Employment Agreement, dated January 29, 2019, by and between ADMA Biologics, Inc. and Brian Lenz (incorporated herein by reference to Exhibit 10.3 to the Company’s
Current Report on Form 8-K, filed with the SEC on January 29, 2019).
10.4.1†
Amendment to Employment Agreement, dated as of September 29, 2021, by and between ADMA Biologics, Inc. 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
1, 2021).
10.5+
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
between Biotest Pharmaceuticals Corporation and ADMA Biologics, Inc. (incorporated herein by reference to Exhibit 10.9 to Amendment No. 3 to the Company’s Current Report on Form 8-K/A, filed with the SEC on June 22, 2012).
10.5.1+
Second Amendment to Plasma Purchase Agreement, dated as of December 18, 2015, by and between Biotest Pharmaceuticals Corporation and ADMA Biologics, Inc. (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).
10.5.2
Third Amendment to Plasma Purchase Agreement, dated as of April 8, 2016, by and between Biotest Pharmaceuticals Corporation and ADMA Biologics, Inc. (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).
10.5.3
Fourth Amendment to Plasma Purchase Agreement, dated as of June 6, 2017, by and between Biotest Pharmaceuticals Corporation and ADMA Biologics, Inc. (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).
10.5.4+
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. (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).
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10.6+
Plasma Supply Agreement, dated as of June 6, 2017, by and between ADMA BioManufacturing, LLC and Biotest Pharmaceuticals Corporation (incorporated herein by reference to Exhibit 10.5 to the Company’s Quarterly Report on Form 10-Q,
filed with the SEC on August 11, 2017).
10.6.1+
Amendment #1 to the Plasma Supply Agreement, dated as of July 19, 2018, by and between Biotest Pharmaceuticals Corporation and ADMA BioManufacturing, LLC (incorporated herein by reference to Exhibit 10.2 to the Company’s Quarterly
Report on Form 10-Q, filed with the SEC on August 10, 2018).
10.7+
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,
filed with the SEC on August 11, 2017).
10.7.1+
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
Form 10-Q, filed with the SEC on August 10, 2018).
10.8
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
10-Q, filed with the SEC on August 12, 2016).
10.9
Lease, effective as of February 17, 2017, by and between Home Center Properties, LLC and ADMA BioCenters Georgia Inc. (incorporated herein by reference to Exhibit 10.22 to the Company’s Annual Report on Form 10-K, filed with the SEC on
February 24, 2017).
10.10
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).
10.11
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
by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed with the SEC on February 12, 2019).
10.12
Amendment No. 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
(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).
10.13
Amendment No. 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).
10.14
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. (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).
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10.15+
License Agreement, effective as of December 31, 2012, by and between ADMA Biologics, Inc. 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
February 11, 2013).
10.15.1
First Amendment to License Agreement, dated as of June 6, 2017, by and between the Company and Biotest AG (incorporated herein by reference to Exhibit 10.8 to the Company’s Quarterly Report on Form 10-Q, filed with the SEC on August
11, 2017).
10.16+
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. (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).
10.16.1+
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. (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).
10.16.2+
Amendment #3 to the Manufacturing Agreement, effective as of December 21, 2017, by and between ADMA BioManufacturing, LLC and Sanofi Pasteur S.A. (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).
10.17
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
June 12, 2017).
10.18+
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
the SEC on March 13, 2019).
10.19++
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,
filed on September 5, 2019).
10.20
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
Form 10-K filed March 12, 2020).
10.21
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).
10.22
Distribution Agreement, dated September 3, 2021, by and between ADMA Biologics, Inc. and Raymond James & Associates, Inc. (incorporated by reference to Exhibit 1.1 to the Company’s Current Report on Form 8-K filed on September 3,
2021).
10.23
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).
10.24
Separation Agreement and Release, dated August 6, 2021, by and between ADMA Biologics, Inc. 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).
10.25
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
the SEC on March 24, 2022).
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10.25.1*
Amendment No. 1 to Credit Agreement and Guaranty, dated March 23, 2023 by and among the Company, Hayfin Services LLP and the lenders party thereto.
10.26
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
the SEC on March 24, 2022).
10.27†
ADMA Biologics, Inc. 2022 Equity Compensation Plan (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed with the Commission on June 21, 2022)
21.1*
Subsidiaries of the Company.
23.1*
Consent of CohnReznick LLP.
31.1*
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.
31.2*
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.
32.1**
Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2**
Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101*
The following materials from ADMA Biologics, Inc. Form 10-K for the year ended December 31, 2022, formatted in Extensible Business Reporting Language (XBRL): (i) Consolidated Balance Sheets at December 31, 2022 and December 31, 2021,
(ii) Consolidated Statements of Operations for the years ended December 31, 2022 and 2021, (iii) Consolidated Statements of Changes in Stockholders’ Equity for the years ended December 31, 2022 and 2021, (iv) Consolidated Statements of
Cash Flows for the years ended December 31, 2022 and 2021; and (v) Notes to Consolidated Financial Statements.
104
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
+ Confidential treatment has been granted with respect as to certain portions of this exhibit. Such portions have been redacted and submitted separately to the SEC.
++ Portions of this exhibit and the schedules thereto have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K.
* Filed herewith.
** Furnished herewith.
† Management compensatory plan, contract or arrangement.
Item 16.
Form 10-K Summary
None.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
ADMA Biologics, Inc.
Date: March 23, 2023
By:
/s/ Adam S. Grossman
Name:
Title:
Adam S. Grossman
President and Chief Executive Officer
Pursuant to the requirements of the Securities Exchange Act of 1934, report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated:
Signature
Title
Date
/s/ Adam S. Grossman
Adam S. Grossman
President and Chief Executive Officer (Principal Executive Officer) and Director
March 23, 2023
/s/ Brian Lenz
Brian Lenz
Executive Vice President and Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)
March 23, 2023
/s/ Steven A. Elms
Steven A. Elms
Chairman of the Board of Directors
March 23, 2023
/s/ Dr. Jerrold B. Grossman
Dr. Jerrold B. Grossman
Vice Chairman of the Board of Directors
March 23, 2023
/s/ Martha J. Demski
Martha J. Demski
Director
March 23, 2023
/s/ Bryant E. Fong
Bryant E. Fong
Director
March 23, 2023
/s/ Lawrence P. Guiheen
Lawrence P. Guiheen
Director
March 23, 2023
/s/ Young T. Kwon
Young T. Kwon
Director
March 23, 2023
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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
CONSOLIDATED FINANCIAL STATEMENTS
TABLE OF CONTENTS
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID ) 596
F-2
Consolidated Balance Sheets as of December 31, 2022 and 2021
F-4
Consolidated Statements of Operations for the years ended December 31, 2022 and 2021
F-5
Consolidated Statements of Changes in Stockholders’ Equity for the years ended December 31, 2022 and 2021
F-6
Consolidated Statements of Cash Flows for the years ended December 31, 2022 and 2021
F-7
Notes to Consolidated Financial Statements
F-8
F-1
Table of Contents
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and
Stockholders of ADMA Biologics, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of ADMA Biologics, Inc. and subsidiaries (the “Company”) as of December 31, 2022 and 2021; the related
consolidated statements of operations, changes in stockholders’ equity, and cash flows for the years then ended; and, the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated
financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for the years then ended in conformity with accounting
principles generally accepted in the United States of America.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated
financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with
the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance
about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial
reporting. 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. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and
performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting
principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
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
and that: (1) relate to accounts or disclosures that are material to the consolidated financial statements, and (2) involved especially challenging, subjective, or complex judgments. The 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 critical audit matters or on the accounts or disclosures to
which they relate.
Inventory
Description of the matter
As of December 31, 2022, the Company’s inventory totaled $163,280,047. As described in the notes to the consolidated financial statements, the valuation of inventory
involves significant estimates relating to the capitalization of labor and overhead costs to the work in process and finished goods inventories as well as lower of cost or net realizable value considerations. Given the significance of the
inventory value, the importance of inventory to the Company’s operations, the various components and the multiple locations and the complexity of the computations, auditing the inventory was challenging and involved a relatively high degree of
auditor judgement and subjectivity, extensive testing, and the involvement of more senior members of the engagement team to design the appropriate responsive audit procedures and to supervise, execute and review the test results.
F-2
Table of Contents
How we addressed the matter in our audit
We obtained an understanding of and tested the Company’s process to estimate labor and overhead in the inventory to devise our responsive audit approach. We
performed substantive test procedures relating to the inventory valuation, which included verifying significant components of the valuation to supporting records, assessing the application of direct labor costs included in the valuation and
assessing the appropriateness of the components of the indirect overhead pools as well as the application of such pool to the valuation. We verified the completeness and accuracy of the data used in management’s valuation and the mathematical
accuracy of the direct labor and overhead applications. To assess management’s assertion that inventory is carried at the lower of cost or net realizable value, we tested subsequent sales transactions and net sales proceeds.
Sales Rebate Liabilities
Description of the matter
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,
wholesaler chargebacks and other wholesaler fees. 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. Medicaid, Medicare Part D, and managed care is complex because of the subjectivity of certain assumptions
and judgments required to develop estimates. These significant assumptions and judgments include consideration of legal interpretations of applicable laws and regulations, historical claims experience, payer channel mix, current contract
prices, unbilled claims and claims submission time lags. Additionally, auditing this matter is challenging given the Company’s limited history in selling certain of its products.
How we addressed the matter in our audit
We obtained an understanding of the Company’s process to estimate rebate liabilities to devise our responsive audit approach. We performed substantive test procedures related to the rebate accruals, which included testing the significant
assumptions and mathematical accuracy. We tested the completeness and accuracy of the data used in the estimates and developed expectations of the key inputs using independent sources. 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. Finally, we considered subsequent events and any new information after the financial statement
date that would require an adjustment to the accruals.
Liquidity Analysis
Description of the matter
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
issuance of these consolidated financial statements. 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. 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 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. We obtained and audited management’s projections, considering their completeness with respect to cash obligations.
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. We compared the data provided to sensitivity adjusted
projections, made inquiries of management and applied our industry knowledge. Finally, we considered management’s overall ability to put forth reasonable projections based on the performance of retrospective audit procedures on historic cash
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.
Parsippany, New Jersey
March 23, 2023
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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
December 31, 2022 and 2021
December 31,
December 31,
2022
2021
ASSETS
Current assets:
Cash and cash equivalents
$
86,521,542
$
51,089,118
Accounts receivable, net
15,505,048
28,576,857
Inventories
163,280,047
124,724,091
Prepaid expenses and other current assets
5,095,146
4,339,245
Total current assets
270,401,783
208,729,311
Property and equipment, net
58,261,481
50,935,074
Intangible assets, net
1,013,415
1,728,768
Goodwill
3,529,509
3,529,509
Right to use assets
10,485,447
7,262,658
Deposits and other assets
4,770,246
4,067,404
TOTAL ASSETS
$
348,461,881
$
276,252,724
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$
13,229,390
$
12,429,409
Accrued expenses and other current liabilities
24,989,349
17,214,988
Current portion of deferred revenue
142,834
142,834
Current portion of lease obligations
905,369
591,084
Total current liabilities
39,266,942
30,378,315
Senior notes payable, net of discount
142,833,063
94,866,239
Deferred revenue, net of current portion
1,833,031
1,975,865
End of term fee
1,500,000
-
Lease obligations, net of current portion
10,704,176
7,462,388
Other non-current liabilities
350,454
397,351
TOTAL LIABILITIES
196,487,666
135,080,158
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS’ EQUITY
Preferred Stock, $ 0.0001 par value, 10,000,000 shares authorized, no
shares issued and outstanding
-
-
Common Stock - voting, $ 0.0001 par value, 300,000,000 shares authorized, 221,816,930
and 195,813,817 shares issued and outstanding
22,182
19,581
Additional paid-in capital
629,968,704
553,265,706
Accumulated deficit
( 478,016,671
)
( 412,112,721
)
TOTAL STOCKHOLDERS’ EQUITY
151,974,215
141,172,566
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$
348,461,881
$
276,252,724
The accompanying notes are an integral part of these consolidated financial statements.
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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF
OPERATIONS
Years Ended December 31, 2022 and 2021
Years Ended December 31,
2022
2021
REVENUES:
Product revenue
$
153,936,858
$
80,799,791
License revenue
142,834
142,834
Total revenues
154,079,692
80,942,625
Cost of product revenue
118,814,535
79,769,341
Gross profit
35,265,157
1,173,284
OPERATING EXPENSES:
Research and development
3,613,764
3,646,060
Plasma center operating expenses
17,843,096
12,288,723
Amortization of intangible assets
715,353
715,353
Selling, general and administrative
52,458,024
42,896,889
Total operating expenses
74,630,237
59,547,025
LOSS FROM OPERATIONS
( 39,365,080
)
( 58,373,741
)
OTHER INCOME (EXPENSE):
Interest income
44,833
34,532
Interest expense
( 19,279,373
)
( 13,056,834
)
Loss on extinguishment of debt
( 6,669,941
)
-
Other expense
( 634,389
)
( 251,575
)
Other expense, net
( 26,538,870
)
( 13,273,877
)
NET LOSS
$
( 65,903,950
)
$
( 71,647,618
)
BASIC AND DILUTED LOSS PER COMMON SHARE
$
( 0.33
)
$
( 0.51
)
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:
Basic and Diluted
197,874,895
139,578,538
The accompanying notes are an integral part of these consolidated financial statements.
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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’
EQUITY
Years Ended December 31, 2022 and 2021
Additional
Total
Common Stock
Paid-in
Accumulated
Stockholders’
Shares
Amount
Capital
Deficit
Equity
Balance at December 31, 2020
104,902,888
$
10,490
$
428,704,039
$
( 340,465,103
)
$
88,249,426
Stock-based compensation
-
-
3,488,253
-
3,488,253
Issuance of common stock, net of offering expenses
90,846,029
9,085
121,135,018
-
121,144,103
Vesting of Restricted Stock Units, net of shares withheld for taxes and retired
64,900
6
( 61,604
)
-
( 61,598
)
Net loss
-
-
-
( 71,647,618
)
( 71,647,618
)
Balance at December 31, 2021
195,813,817
19,581
553,265,706
( 412,112,721
)
141,172,566
Stock-based compensation
-
-
5,214,531
-
5,214,531
Warrants issued in connection with note payable
-
-
9,569,604
-
9,569,604
Vesting of Restricted Stock Units, net of shares withheld for taxes
1,808,561
181
( 2,899,021
)
-
( 2,898,840
)
Stock options exercised
68,679
7
175,008
-
175,015
Issuance of common stock, net of offering expenses
24,125,873
2,413
64,642,876
-
64,645,289
Net loss
-
-
-
( 65,903,950
)
( 65,903,950
)
Balance at December 31, 2022
221,816,930
$
22,182
$
629,968,704
$
( 478,016,671
)
$
151,974,215
The accompanying notes are an integral part of these consolidated financial statements.
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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF
CASH FLOWS
Years Ended December 31, 2022 and 2021
Years Ended December 31,
2022
2021
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$
( 65,903,950
)
$
( 71,647,618
)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
7,113,369
5,495,502
Loss on disposal of fixed assets
426,536
220,761
Interest paid in kind
2,997,746
-
Stock-based compensation
5,214,531
3,488,253
Amortization of debt discount
2,401,669
1,897,373
Loss on extinguishment of debt
6,669,941
-
Amortization of license revenue
( 142,834
)
( 142,834
)
Changes in operating assets and liabilities:
Accounts receivable
13,071,809
( 15,339,567
)
Inventories
( 38,555,957
)
( 43,188,489
)
Prepaid expenses and other current assets
( 755,900
)
( 1,292,779
)
Deposits and other assets
122,468
( 1,775,205
)
Accounts payable
799,981
1,355,700
Accrued expenses
7,534,572
8,341,341
Other current and non-current liabilities
( 502,238
)
218,580
Net cash used in operating activities
( 59,508,257
)
( 112,368,982
)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment
( 13,911,171
)
( 13,511,258
)
Net cash used in investing activities
( 13,911,171
)
( 13,511,258
)
CASH FLOWS FROM FINANCING ACTIVITIES:
Principal payments on notes payable
( 100,000,000
)
-
Proceeds from issuance of common stock, net of offering expenses
64,645,289
121,144,103
Payment of debt refinancing fees
( 2,000,000
)
-
Proceeds from issuance of note payable
151,750,000
-
Taxes paid on vested Restricted Stock Units
( 2,898,840
)
( 61,598
)
Payments on finance lease obligations
( 36,684
)
( 34,299
)
Proceeds from the exercise of stock options
175,015
-
Payment of deferred financing fees
( 2,782,928
)
-
Net cash provided by financing activities
108,851,852
121,048,206
Net increase (decrease) in cash and cash equivalents
35,432,424
( 4,832,034
)
Cash and cash equivalents - beginning of year
51,089,118
55,921,152
Cash and cash equivalents - end of year
$
86,521,542
$
51,089,118
The accompanying notes are an integral part of these consolidated financial statements.
F-7
Table of Contents
ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2022 AND 2021
1.
ORGANIZATION AND BUSINESS
ADMA Biologics, Inc. (“ADMA” or the “Company”) is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing
and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. The Company’s targeted patient populations include immune-compromised
individuals who suffer from an underlying immune deficiency disorder or who may be immune-suppressed for medical reasons.
ADMA operates through its wholly-owned subsidiaries ADMA BioManufacturing, LLC (“ADMA BioManufacturing”) and ADMA BioCenters Georgia Inc.
(“ADMA BioCenters”). ADMA BioManufacturing was formed in January 2017 to facilitate the acquisition of the Biotest Therapy Business Unit (“BTBU”) from BPC Plasma, Inc. (formerly Biotest Pharmaceuticals Corporation) (“BPC” and, together with
Biotest AG, “Biotest”) on June 6, 2017. The acquisition included certain assets (the “Biotest Assets”) of BTBU, which included the U.S. Food and Drug Administration (“FDA”)-licensed BIVIGAM and Nabi-HB immunoglobulin products, and an FDA-licensed
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. ADMA BioCenters is the Company’s source plasma
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
FDA-approved products, all of which are currently marketed and commercially available: (i) BIVIGAM (Immune Globulin Intravenous, Human), an Intravenous Immune Globulin (“IVIG”) product indicated for the treatment of Primary Humoral
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; (ii) ASCENIV (Immune
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; and (iii) Nabi-HB (Hepatitis B
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. In addition to its commercially available immunoglobulin
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. The Company seeks to
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. Based
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,
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
cash flow from operations. 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 the acceptability of ADMA’s immune globulin products by physicians, patients or payers. 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 capital improvements will be successfully completed or that any product developed in the future will be approved. The Company is subject to risks common to companies in the biotechnology and pharmaceutical manufacturing
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,
protection of proprietary technology, and compliance with FDA and other governmental regulations and approval requirements.
F-8
Table of Contents
ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2022 AND 2021
The Company continues to evaluate a variety of strategic alternatives through its ongoing engagement with Morgan Stanley. The exploration
of value-creating opportunities remains a top corporate priority for ADMA.
On December 9, 2022, the Company issued 24,125,873
shares of its common stock through an underwritten public offering and received net proceeds of $ 64.6 million, and on March 23, 2022
the Company received approximately $ 47.0 million in net proceeds from the refinancing of its senior credit facility (see Note 7).
2.
SIGNIFICANT ACCOUNTING POLICIES
Principles of consolidation and basis of presentation
The accompanying consolidated financial statements include the accounts of ADMA and its wholly-owned subsidiaries, and have been prepared
in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and in accordance with Article 8 of Regulation S-X of the Securities and Exchange Commission (the “SEC”). All intercompany balances have
been eliminated in consolidation. Any reference in these notes to applicable guidance is meant to refer to U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting
Standards Board (the “FASB”). During the years ended December 31, 2022 and 2021, comprehensive loss was equal to the net loss amounts presented for the respective periods in the accompanying consolidated statements of operations.
Use of estimates
The preparation of financial statements requires management to make estimates and assumptions that affect the reported amounts of assets
and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
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
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
The Company considers all highly liquid instruments purchased with a maturity of three months or less to be cash equivalents.
The Company regularly maintains cash and cash equivalents at third-party financial institutions in excess of the Federal Deposit Insurance
Corporation insurance limit. Although the Company monitors the daily cash balances in its operating accounts and adjusts the balances as appropriate, these balances could be impacted, and there could be a material adverse effect on the Company’s
business, if one or more of the financial institutions with which the Company has deposits fails or is subject to other adverse conditions in the financial or credit markets. To date, the Company has not experienced a loss or lack of access to
its deposited cash or cash equivalents; however, the Company cannot provide assurance that access to its cash and cash equivalents will not be impacted by adverse conditions in the financial and credit markets in the future.
Accounts receivable
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
December 31, 2022 and 2021, respectively, which are recognized in the period the related revenue is recorded. The Company extends credit to its customers based upon an evaluation of each customer’s financial
condition and credit history. Evaluations of the financial condition and associated credit risk of customers are performed on an ongoing basis. Based on these evaluations, the Company has concluded that its credit risk is minimal (see
Note 16).
Inventories
Raw materials inventory consists of various materials purchased from suppliers, including normal source plasma, used in the production of
the Company’s products. Work-in-process and finished goods inventories (see Note 3) reflect the cost of raw materials as well as costs for direct and indirect labor, primarily salaries, wages and benefits for applicable employees, as well as an
allocation of overhead costs related to the Boca Facility including utilities, property taxes, general repairs and maintenance, consumable supplies and depreciation. The allocation of Boca Facility overhead to inventory is generally based upon
the estimated square footage of the Boca Facility that is used in the production of the Company’s products relative to the total square footage of the facility.
F-9
Table of Contents
ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2022 AND 2021
Inventories, including plasma intended for resale and plasma intended for internal use in the Company’s manufacturing, commercialization
or research and development activities, are carried at the lower of cost or net realizable value determined by the first-in, first-out method. For both the Company’s immune globulin products and plasma intended for resale and internal use, net
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. The estimates for net realizable value of inventory are based
on contractual terms or upon historical experience and certain other assumptions, and the Company believes that such assumptions are reasonable. 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 charge to cost of product revenue, when the carrying value or historical cost exceeds its estimated net realizable value. In addition, costs
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
Assets comprising property and equipment (see Note 4) are stated at cost less accumulated depreciation. Depreciation is calculated using
the straight-line method over the asset’s estimated useful life. Land is not depreciated. The buildings have been assigned a useful life of 30 years .
Property and equipment other than land and buildings have useful lives ranging from 3 to 15 years . Leasehold improvements are amortized over the lesser of the lease term or their estimated useful lives.
Goodwill
Goodwill represents the excess of purchase price over the fair value of net assets acquired by the Company. Goodwill at December 31, 2022
and 2021 was $ 3.5 million, all of which is attributable to the Company’s ADMA BioManufacturing business segment. There were no changes to the carrying amount of goodwill during the years ended December 31, 2022 and 2021.
Goodwill is not amortized but is assessed for impairment on an annual basis or more frequently if impairment indicators exist. The Company
has the option to perform a qualitative assessment of goodwill to determine whether it is more likely than not that the fair value of its reporting unit is less than its carrying amount, including goodwill and other intangible assets. If the
Company concludes that this is the case, then it must perform a goodwill impairment test by comparing the fair value of the reporting unit to its carrying value. An impairment charge is recorded to the extent the reporting unit’s carrying value
exceeds its fair value, not to exceed the total amount of goodwill allocated to that reporting unit. The Company performs its annual goodwill impairment test as of October 1 of each year. The Company’s annual goodwill impairment tests as of
October 1, 2022 and 2021 did not result in any impairment charges related to goodwill for the years ended December 31, 2022 and 2021.
Impairment of long-lived assets
The Company assesses the recoverability of its long-lived assets, which include property and equipment and finite-lived intangible assets,
whenever significant events or changes in circumstances indicate impairment may have occurred. If indicators of impairment exist, projected future undiscounted cash flows associated with the asset are compared to its carrying amount to determine
whether the asset’s carrying value is recoverable. Any resulting impairment is recorded as a reduction in the carrying value of the related asset in excess of fair value and a charge to operating results. For the years ended December 31, 2022 and
2021, the Company determined that there was no impairment of its long-lived assets.
Revenue recognition
Revenues for the years ended December 31, 2022 and 2021 are comprised of (i) revenues from the sale of the Company’s immunoglobulin
products, BIVIGAM, ASCENIV and Nabi-HB, (ii) product revenues from the sale of human plasma collected by the Company’s Plasma Collection Centers business segment, (iii) contract manufacturing and laboratory services revenue, (iv) revenues from
the sale of intermediate by-products; and (v) license and other revenues primarily attributable to the out-licensing of ASCENIV to Biotest in 2012 to market and sell this product in Europe and selected countries in North Africa and the Middle
East. Biotest has provided the Company with certain services and financial payments in accordance with the related Biotest license agreement and is obligated to pay the Company certain amounts in the future if certain milestones are achieved.
Deferred revenue is amortized into income over the term of the Biotest license, representing a period of approximately 22 years .
F-10
Table of Contents
ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2022 AND 2021
Product revenue is recognized when the customer is deemed to have control over the product. Control is determined based on when the
product is shipped or delivered and title passes to the customer. Revenue is recorded in an amount that reflects the consideration the Company expects to receive in exchange. Revenue from the sale of the Company’s immunoglobulin products is
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.
These estimates are based on contractual arrangements, historical experience and certain other assumptions, and the Company believes that such estimates are reasonable. For revenues associated with contract manufacturing and the sale of
intermediates, control transfers to the customer and the performance obligation is satisfied when the customer takes possession of the product from the Boca Facility or from a 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
the product has been transferred to the customer, which generally occurs at the time of shipment. Product revenues are recognized at the time of delivery if the Company retains control of the product during shipment.
Cost of product revenue
Cost of product revenue includes costs associated with the manufacture of the Company’s FDA approved products and intermediates and for
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. When the activities of
these operations are attributable to new products in development, the expenses are classified as research and development expenses.
Research and development expenses
Research and development expenses consist of clinical research organization costs, costs related to clinical trials, post-marketing
commitment studies for BIVIGAM and ASCENIV, wages, benefits and stock-based compensation for employees directly related to research and development activities. All research and development costs are expensed as incurred.
Plasma center operating expenses
Plasma center operating expenses consist of certain general and administrative plasma center costs, initial opening, marketing and
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
Advertising and marketing expense includes cost for promotional materials and trade show expenses for the marketing of the Company’s
products and services and expenses incurred for attracting donors to the Company’s plasma collection centers. All advertising and marketing expenses are expensed as incurred. Advertising and marketing expenses were $ 2.2 million and $ 1.4 million for the
years ended December 31, 2022 and 2021, respectively.
Stock-based compensation
The Company follows recognized accounting guidance which requires all equity-based payments, including grants of stock options, to be
recognized in the statement of operations as compensation expense based on their fair values at the date of grant. Compensation expense related to awards to employees and directors with service-based vesting conditions is recognized on a
straight-line basis over the associated vesting period of the award based on the grant date fair value of the award. Stock options granted under the Company’s equity incentive plans generally have a four-year vesting period and a term of 10 years . For
milestone-based equity awards (see Note 8) the Company periodically assesses the probability of vesting for each milestone-based award and adjusts compensation expense based on its probability assessment. Pursuant to ASU No. 2016-09, Improvements to Employee Share-Based Payment Accounting (Topic 718) , the Company has elected not to establish a forfeiture rate, as stock-based compensation expense related to forfeitures of unvested equity
awards is fully reversed at the time of forfeiture.
F-11
Table of Contents
ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2022 AND 2021
Income taxes
The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in
the consolidated financial statements or its tax returns. Under this method, deferred tax assets and liabilities are recognized for the temporary differences between the tax bases of assets and liabilities and their respective financial reporting
amounts at enacted tax rates in effect for the years in which the temporary differences are expected to reverse. The Company records a valuation allowance on its deferred tax assets if it is more likely than not that the Company will not generate
sufficient taxable income to utilize its deferred tax assets (see Note 11). The Company is subject to income tax examinations by major taxing authorities for all tax years since 2018 and for previous periods as it relates to the Company’s net
operating loss carryforwards.
Loss Per Share
Basic loss per share is computed by dividing net loss attributable to common stockholders by the weighted average number of shares of
common stock outstanding during the period. Diluted loss per share is calculated by dividing net loss attributable to common stockholders as adjusted for the effect of dilutive securities, if any, by the weighted average number of shares of
common stock and dilutive common stock outstanding during the period. Potentially dilutive common stock includes the shares of common stock issuable upon the exercise of outstanding stock options and warrants (using the treasury stock method).
Potentially dilutive common stock in the diluted net loss per share computation is excluded to the extent that it would be anti-dilutive. No potentially dilutive securities are included in the computation of any diluted per share amounts as the
Company reported a net loss for all periods presented. For the years ended December 31, 2022 and 2021, the following securities were excluded from the calculation of diluted loss per common share because of their anti-dilutive
effects:
For the Years Ended December 31,
2022
2021
Stock options
8,256,211
7,862,722
Restricted Stock Units
2,866,987
4,485,133
Warrants
13,525,148
4,528,160
24,648,346
16,876,015
Fair value of financial instruments
The carrying amounts of certain of the Company’s financial instruments, including cash and cash equivalents, accounts receivable and
accounts payable are shown at cost, which approximates fair value due to the short-term nature of these instruments. The debt outstanding under the Company’s senior notes payable (see Note 7) approximates fair value due to the variable interest
rate on this debt.
Recent Accounting Pronouncements
There were no new accounting
pronouncements adopted during the years ended December 31, 2022 and 2021 that had a significant impact on the Company’s consolidated financial statements.
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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2022 AND 2021
3.
INVENTORIES
The following table provides the components of inventories:
December 31,
2022
December 31,
2021
Raw materials
$
48,644,527
$
36,755,720
Work-in-process
56,170,853
58,968,535
Finished goods
58,464,667
28,999,836
Total inventories
$
163,280,047
$
124,724,091
Raw materials includes plasma and other materials expected to be used in the production of BIVIGAM, ASCENIV and Nabi-HB. These materials
will be consumed in the production of goods expected to be available for sale or otherwise have alternative uses that provide a probable future benefit. All other activities and materials associated with the production of inventories used in
research and development activities are expensed as incurred.
Work-in-process inventory primarily consists of bulk drug substance and unlabeled filled vials of the Company’s immunoglobulin products.
Finished goods inventory is comprised of immunoglobulin product inventory and related intermediates that are available for commercial
sale, as well as plasma collected at the Company’s plasma collection centers which is expected to be sold to third-party customers.
4.
PROPERTY AND EQUIPMENT
Property and equipment at December 31, 2022 and 2021 is summarized as follows:
December 31, 2022
December 31, 2021
Manufacturing and laboratory equipment
$
18,767,807
$
16,702,991
Office equipment and computer software
5,318,669
4,082,462
Furniture and fixtures
5,109,898
3,389,140
Construction in process
6,726,995
5,496,222
Leasehold improvements
17,930,905
11,129,639
Land
4,339,441
4,339,441
Buildings and building improvements
19,544,307
19,067,032
77,738,022
64,206,927
Less: Accumulated depreciation
( 19,476,541
)
( 13,271,853
)
Total property, plant and equipment, net
$
58,261,481
$
50,935,074
The Company recorded depreciation expense on property and equipment of $ 6.4 million and $ 4.8 million for the years ended December 31,
2022 and 2021, respectively.
5.
INTANGIBLE ASSETS
Intangible assets at December 31, 2022 and 2021 consist of the following:
December 31, 2022
December 31, 2021
Cost
Accumulated Amortization
Net
Cost
Accumulated Amortization
Net
Trademark and other intangible rights related to Nabi-HB
$
4,100,046
$
3,270,276
$
829,770
$
4,100,046
$
2,684,554
$
1,415,492
Rights to intermediates
907,421
723,776
183,645
907,421
594,145
313,276
$
5,007,467
$
3,994,052
$
1,013,415
$
5,007,467
$
3,278,699
$
1,728,768
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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2022 AND 2021
Under the previous contract manufacturing agreement between ADMA and BPC, intermediate by-products derived from
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 .
Amortization expense related to the Company’s intangible assets for the years ended December 31, 2022 and 2021 was
$ 0.7 million. Estimated aggregate future aggregate amortization expense is expected to be as follows:
2023
715,352
2024
298,063
6.
ACCRUED EXPENSES AND OTHER LIABILITIES
Accrued expenses and other current liabilities at December 31, 2022 and 2021 are as follows:
December 31, 2022
December 31, 2021
Accrued rebates
$
11,436,484
$
5,040,200
Accrued distribution fees
3,166,896
4,739,651
Accrued incentives
4,193,919
4,066,109
Accrued testing
309,867
1,189,970
Accrued payroll and other compensation
4,086,379
1,197,337
Other
1,795,804
981,721
Total accrued expenses and other current liabilities
$
24,989,349
$
17,214,988
7.
NOTES PAYABLE
Senior Notes Payable
A summary of outstanding senior notes payable is as follows:
December 31, 2022
December 31, 2021
Notes payable
$
154,747,746
$
100,000,000
Less:
Debt discount
( 11,914,683
)
( 5,133,761
)
Senior notes payable
$
142,833,063
$
94,866,239
On March 23, 2022 (the “Hayfin Closing Date”), the Company and all of its subsidiaries entered into a Credit and Guaranty Agreement (the “Hayfin
Credit Agreement”) with Hayfin Services LLP (“Hayfin”). 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
amount of $ 25.0 million (the “ Hayfin Delayed Draw Loan ” and, together with the Hayfin Closing Date Loan, the “Hayfin Loans ”). The obligation of the lenders to make the Hayfin Delayed Draw Loan was to expire on March 22, 2023
(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. 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 Credit Agreement).
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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2022 AND 2021
On the
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
obligations under the Company’s previously existing credit facility (the “Perceptive Credit Facility”) with Perceptive Credit Holdings II, LP (“Perceptive”). 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. In addition, a $ 1.8 million upfront fee payable to Hayfin was paid “in kind” and was added to the outstanding principal balance in accordance with the terms of the
Hayfin Credit Agreement. 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.
Borrowings under the Hayfin
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
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 %),
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
Margin”); provided, however, that upon, and during the continuance of, an Event of Default, the Applicable Margin shall increase by an additional 3 %
per annum. 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. The rate of interest in effect as of the Hayfin Closing Date and as of December 31,
2022 was 10.75 % and approximately 13.9 %,
respectively. 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. From the Hayfin Closing Date through December 31, 2022,
approximately $ 3.0 million of interest was paid in kind and added to the balance of the outstanding Hayfin Loans.
On the Hayfin Maturity Date, the
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. This exit fee is recorded separately as a non-current liability on the accompanying consolidated balance sheet as of December 31, 2022. Prior to the Hayfin
Maturity Date, there are no scheduled principal payments on the Hayfin Loans. The Company may prepay outstanding principal 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 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 %
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 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. 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.
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
equity interests in the Company’s subsidiaries. The Hayfin
Credit Agreement contains certain representations and warranties, affirmative covenants, negative covenants and conditions that are customarily required for similar financings. The negative covenants restrict or limit the ability of the Company
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; engage in certain fundamental corporate changes, such as mergers or acquisitions, or changes to the Company’s or its
subsidiaries’ business activities; make certain Investments or Restricted Payments (each as defined in the Hayfin Credit Agreement); change its fiscal year; pay dividends; repay certain other indebtedness; engage in certain affiliate transactions; or enter into, amend or terminate any
other agreements that have the impact of restricting the Company’s ability to make loan repayments under the Hayfin Credit Agreement. 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; and (ii) as of the last day of each fiscal quarter, report IVIG product and related revenues for the trailing 12-month period that exceed
the amounts set forth in the Hayfin Credit Agreement,
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. As of December 31, 2022, the Company was in compliance with all of the covenants contained in the Hayfin Credit Agreement.
As consideration for the Hayfin
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
shares of the Company’s common stock (the “Hayfin Warrants”). The Hayfin Warrants have an 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 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 .
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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2022 AND 2021
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
Hayfin Loans in the amount of $ 13.9 million. The Company records debt discount as a reduction to the face amount of the debt, and
the debt discount is amortized as interest expense over the life of the debt using the interest method. Based on the fair value of the Hayfin Warrants and the aggregate amount of fees and expenses associated with obtaining the Hayfin Credit
Facility, the effective interest rate on the Hayfin Loans as of the Hayfin Closing Date and as of December 31, 2022 was approximately 13.0 %
and 16.1 %, respectively.
8.
STOCKHOLDERS ’ EQUITY
Preferred Stock
The Company is currently authorized to issue up to 10 million shares of preferred stock, $ 0.0001 par value per share. There were no shares of preferred stock outstanding at December 31, 2022 and 2021.
Common Stock
As of
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
and 195,813,817 shares of common stock were outstanding as of December 31, 2022 and 2021, respectively. 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 Company is authorized to issue from 150,000,000 to 300,000,000 . After giving effect to shares reserved for the
issuance of warrants and for awards issued under the Company’s equity incentive plans, 29,177,763 shares of common stock were
available for issuance as of December 31, 2022.
On December 9, 2022, the Company completed an underwritten public offering whereby the Company issued 24,125,873
shares of its common stock. Net proceeds after underwriting discounts and expenses associated with the offering were approximately $ 64.6
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,
capital expenditures and general corporate purposes.
During the year
ended December 31, 2022, outstanding stock options aggregating to 68,679 shares of common stock were exercised, and the Company
received net proceeds from the exercises of approximately $ 0.2 million.
On October 25, 2021,
the Company completed an underwritten public offering whereby the Company issued 57.5 million shares of common stock and received
gross proceeds of $ 57.5 million. Net proceeds after underwriting discounts and expenses associated with the offering were approximately
$ 53.8 million, and were used to advance the commercial sales of the Company’s FDA approved products through the procurement of raw
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
compliance, to explore business development opportunities and for general corporate purposes and other capital expenditures.
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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2022 AND 2021
On
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,
up to an aggregate of $ 50 million of shares of the Company’s common stock (the “Distribution Agreement”). The Company currently
intends to use any net proceeds from the sale of its common stock under the Distribution Agreement for general corporate purposes, including procurement of source plasma and other raw materials, supply chain initiatives and production
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. T he Company currently has approximately $ 42.8
million of shares available to sell under the Distribution Agreement. There were no sales under the Distribution Agreement during the year ended December 31, 2022 . 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.
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 option, through or to Jefferies, up to an aggregate of $ 50 million of shares of the Company’s common stock. On November 5, 2020 and 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. The Sale Agreement was terminated on August 31, 2021. 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.
Warrants
On March 23, 2022, the Company issued the Hayfin Warrants, whereby affiliates
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). The Hayfin Warrants was valued at $ 9.6 million, using the Black-Scholes option pricing model assuming an expected term of 7
years, a volatility of 68.1 %, a dividend yield of 0 % and a risk-free interest rate of 2.36 %.
During the year ended December 31, 2022, warrants to
purchase 31,750 shares of common stock that had been issued to a former noteholder of the Company expired. At December 31,
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
dates ranging between May 2023 and December 2030.
Equity Incentive Plans
From
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
amended, was approved by the Company’s Board of Directors (the “Board”) on March
15, 2017 and by the Company’s stockholders on May 25, 2017. The maximum number of shares that were reserved for grant under the 2014 Plan was: (a) 2,334,940 shares; plus (b) an annual increase as of the first day of the Company’s fiscal year, beginning in 2018 and occurring each year thereafter through 2022, equal to 4 % of the outstanding shares of common stock as of the end of the Company’s immediately preceding fiscal year, or any lesser number of shares
determined by the Board; provided, however, that no more than an aggregate of 10 million shares of common stock may be issued
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
shares were available for issuance under the 2014 Plan. In accordance with the foregoing, on January 1, 2022 the aggregate number of shares available for issuance increased to 7,901,643 .
F-17
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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2022 AND 2021
During the years
ended December 31, 2022 and 2021, the Company granted options to purchase an aggregate of 1,194,032 and 1,895,550 shares of common stock, respectively, to its directors and employees under the 2014 Plan. The fair value of stock options granted was
determined on the date of grant using the Black-Scholes model. 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
transferable. 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. To
determine the risk-free interest rate, the Company utilized the U.S. Treasury yield curve in effect at the time of the grant with a term consistent with the term of the awards granted by the Company. 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 terms. The expected dividend yield reflects the Company’s current and expected future policy for dividends on
the Company’s common stock. 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
stock became publicly traded in the fourth quarter of 2013.
The grant
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:
Years Ended
December 31,
2022
December 31,
2021
Expected term
5.5 - 6.3 years
5.5 - 6.3 years
Volatility
68
%
68 - 70
%
Dividend yield
0.0
0.0
Risk-free interest rate
1.72 - 1.73
%
0.80 - 1.27
%
On June 21, 2022, the Company’s stockholders approved the ADMA Biologics, Inc. 2022 Compensation Plan (the “2022 Equity Plan”). Approval of the 2022 Equity Plan resulted in approximately 18
million additional shares of the Company’s common stock being reserved for future awards. 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
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. 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. ISOs and NQOs may be granted to employees, consultants or Board members at an option price not less than the fair market
value of the common stock subject to the stock option agreement. The following
table summarizes information about stock options outstanding as of December 31, 2022 and 2021:
Shares
Weighted
Average
Exercise Price
Options outstanding, vested and expected to vest at December 31, 2020
6,922,931
$
4.40
Forfeited
( 529,202
)
$
2.89
Expired
( 426,557
)
$
4.91
Granted
1,895,550
$
2.14
Exercised
-
$
-
Options outstanding, vested and expected to vest at December 31, 2021
7,862,722
$
3.93
Forfeited
( 31,540
)
$
2.37
Expired
( 700,324
)
$
6.86
Granted
1,194,032
$
1.67
Exercised
( 68,679
)
$
2.55
Options outstanding, vested and expected to vest at December 31, 2022
8,256,211
$
3.37
Options exercisable
6,213,959
$
3.80
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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2022 AND 2021
As of December 31, 2022, the Company had $ 2.3
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. The following table summarizes additional
information regarding outstanding and exercisable options under the stock option plans at December 31, 2022:
Stock Options Outstanding
Stock Options Exercisable
Range of
Exercise Prices
Options Outstanding
Weighted
Average
Remaining
Contractual
Life (Years)
Weighted Average Exercise Price
Aggregate Intrinsic Value
Options Outstanding
Weighted
Average
Remaining
Contractual
Life (Years)
Weighted Average Exercise Price
Aggregate Intrinsic Value
$ 1.10 - $ 1.67
1,523,824
9.1
$
1.61
$
3,452,237
406,160
9.0
$
1.52
$
959,663
$ 1.73 - $ 2.60
1,623,353
8.0
$
2.35
2,491,181
943,200
8.0
$
2.36
1,430,931
$ 2.62 - $ 3.93
4,083,311
5.0
$
3.46
1,696,824
3,852,447
4.8
$
3.49
1,495,461
$ 3.98 - $ 5.97
470,428
4.7
$
5.03
-
456,857
4.6
$
5.06
-
$ 6.02
- $ 9.03
307,795
1.5
$
8.05
-
307,795
1.5
$
8.05
-
$ 9.37 - $ 10.80
247,500
1.9
$
10.28
-
247,500
1.9
$
10.28
-
8,256,211
6.1
$
3.37
$
7,640,242
6,213,959
5.3
$
3.80
$
3,886,055
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
shares, respectively, to certain management employees of the Company and during 2022, to members of the Board. Except for the RSUs granted under the Company’s retention incentive program discussed below, the RSUs generally vest annually over a
period of four years for employees and semi-annually over a period of one year for directors. 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 Company issued an aggregate of 2,685,000 time-based RSUs and 1,147,500 milestone-based RSUs. Fifty percent of the time-based RSUs granted under the retention incentive program vested on December 31, 2022, with the remainder vesting in
quarterly installments through December 31, 2024. The milestone-based RSUs vested upon achievement of the applicable milestone, and all of the milestone-based RSUs vested during the
year ended December 31, 2022. 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 .
During the years ended December 31, 2022 and 2021, 2,727,412
and 92,750 shares, respectively,
vested in connection with grants of RSUs. With respect to the RSUs vested during the year ended December 31, 2022, 918,851 shares
valued at approximately $ 2.9 million were withheld by the Company to cover employees’ tax liabilities . For the RSUs vested during the year ended December 31, 2021 , 27,850
shares valued at approximately $ 62,000 were withheld by the Company to cover employees’ tax liabilities. These shares have been retired by the
Company or were otherwise no longer outstanding as of December 31, 2022 . A summary of the Company’s unvested RSU activity and related information is as
follows:
Shares
Weighted
Average Grant
Date Fair Value
Balance at December 31, 2020
326,000
$
2.81
Granted
4,384,744
$
1.30
Vested
( 92,750
)
$
2.82
Forfeited
( 132,861
)
$
2.51
Balance at December 31, 2021
4,485,133
$
1.34
Granted
1,174,266
$
1.74
Vested
( 2,727,412
)
$
1.25
Forfeited
( 65,000
)
$
1.40
Balance at December 31, 2022
2,866,987
$
1.59
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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2022 AND 2021
As of December 31, 2022, the Company had $ 3.8 million of unrecognized compensation expense related to unvested RSUs granted
under the Company’s equity incentive plans, which is expected to be recognized over a weighted-average period of 2.4 years.
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:
2022
2021
Research and development
$
19,476
$
153,924
Plasma center operating expenses
81,668
60,257
Selling, general and administrative
4,716,219
2,958,008
Cost of product revenue
397,168
316,064
Total stock-based compensation expense
$
5,214,531
$
3,488,253
9.
RELATED PARTY TRANSACTIONS
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
to time , and pays monthly rent on this facility in the amount of $ 10,000 . On October 18, 2022 , the Company amended the agreement to extend its term to December 31, 2026 , with automatic successive one-year
renewals thereafter. Either party may terminate the agreement by providing the other party with one year ’s prior written notice . Rent expense for the years ended December 31, 2022 and 2021 amounted to $ 0.1
million. Areth is a company controlled by Dr. Jerrold B. Grossman, the Vice Chairman of the Board, and Adam S. Grossman, the Company’s President and Chief Executive Officer. The Company also reimburses Areth for office, warehousing and building
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
million. Genesis is owned by Dr. Grossman and Adam Grossman.
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.
During
the year ended December 31, 2021, in connection with the resignation of Dr. 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. Mond. These payments were made in scheduled installments over
a period of 10 months.
In
connection with the 2022 public offering of the Company’s common stock (see Note 8) on December 9, 2022: (i) Mr. Grossman purchased 14,983
shares of common stock directly and 14,982 shares of common stock indirectly through an entity he controls, and (ii) Brian Lenz, the
Company’s Executive Vice President and Chief Financial Officer, purchased 6,993 shares of common stock, all at the public offering
price of $ 2.86 per share.
In connection with
the 2021 public offering of the Company’s common stock (see Note 8) on October 25, 2021: (i) Mr. Grossman purchased 100,000 shares of
common stock directly and 250,000 shares of common stock indirectly
through an entity he controls, (ii) Dr. Grossman purchased 100,000 shares of common stock, (iii) Dr. 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
share.
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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2022 AND 2021
10.
COMMITMENTS AND CONTINGENCIES
General Legal Matters
From time to time the Company is or may become subject to certain legal proceedings and claims arising in connection with the normal
course of its business. Management does not expect that the outcome of any such claims or actions will have a material effect on the Company’s liquidity, results of operations or financial condition.
COVID-19 Pandemic
The Company continues to monitor the ongoing developments related to the COVID-19 pandemic, including the emergence of the
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
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. A substantial portion of such testing has historically
been performed by contract laboratories outside the United States.
Due to a combination of previously mandated state and local “shelter-in-place” orders, as well as government stimulus
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. The Company was also subject
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
distribution of its products. 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 elected to carry more raw materials inventory than it has in the past. The COVID-19 pandemic previously impacted, to a certain degree, the Company’s customer engagement initiatives, whereby ADMA’s sales and medical
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
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. Although the Company received FDA approvals for four
of its plasma collection centers during the year ended December 31, 2022 and received several FDA approvals and two 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 future regulatory submissions or applications that may be impacted by restrictions related to
COVID-19.
During the years ended December 31, 2022 and 2021, revenue attributable to international customers was approximately 5 % and 13 %, respectively, of the
Company’s total revenues. 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
of operations, and the Company does not believe that its production operations at the Boca Facility, the Company’s contract fill/finishers or its plasma collection facilities have been significantly impacted by the COVID-19 pandemic. As a result,
the Company does not anticipate and has not experienced any material impairments with respect to any of its long-lived assets, including the Company’s property and equipment, goodwill or intangible assets.
Although the COVID-19 pandemic has not, to date, materially adversely impacted the Company’s capital and financial resources, because the
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
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
operations.
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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2022 AND 2021
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
Company agreed to purchase from BPC an annual minimum volume of source plasma containing antibodies to RSV to be used in the manufacture of ASCENIV. The Company must purchase a to-be-determined and agreed upon annual minimum volume from BPC, but
may also collect high-titer RSV plasma from up to five wholly-owned ADMA plasma collection facilities. During 2015, the Company and
BPC amended the 2011 Plasma Purchase Agreement to allow the Company the ability to collect its raw material RSV high-titer plasma from other third-party collection organizations, thus allowing the Company to expand its reach for raw material
supply as it executes its commercialization plans for ASCENIV. As part of the closing of the Biotest Transaction, the parties amended the 2011 Plasma Purchase Agreement to extend the initial term through the ten-year anniversary of the closing date of the Biotest Transaction. Unless terminated earlier, the 2011 Plasma Purchase Agreement expires in June
2027, after which it may be renewed for two additional five-year periods if agreed to by the parties. On December 10, 2018, BPC assigned its rights and obligations under the 2011 Plasma Purchase Agreement to Grifols Worldwide Operations
Limited (“Grifols”) as its successor-in-interest, effective January 1, 2019. 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
antibodies to RSV from Grifols. Pursuant to this amendment, until January 1, 2022, the Company could 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). Effective January 1, 2022, RSV
plasma purchased from these two plasma collection centers are subject to the pricing terms in effect for RSV plasma purchased from
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
to certain exceptions, to ADMA BioManufacturing an annual minimum volume of hyperimmune plasma that contain antibodies to the Hepatitis B virus for the manufacture of Nabi-HB. The Plasma Supply Agreement has a 10-year term. On July 19, 2018, the Company and BPC entered into an amendment to the Plasma Supply Agreement to provide, among other things, that in
the event BPC elects not to supply in excess of ADMA BioManufacturing’s specified amount of Hepatitis B plasma and ADMA BioManufacturing is unable to secure Hepatitis B plasma from a third party at a price that is within a low double- digit
percentage of the price that ADMA BioManufacturing pays to BPC, then BPC shall reimburse ADMA BioManufacturing for the difference in price ADMA BioManufacturing incurs. On December 10, 2018, BPC assigned its rights and obligations under the
Plasma Supply Agreement to Grifols, effective January 1, 2019.
On June 6, 2017, the Company and BPC entered into a Plasma Purchase Agreement (the “2017 Plasma Purchase Agreement”), pursuant to which
ADMA BioManufacturing purchases normal source plasma (“NSP”) from BPC at agreed upon annual quantities and prices. The 2017 Plasma Purchase Agreement has an initial term of five years after which the 2017 Plasma Purchase Agreement may be renewed for additional two
terms of two years each upon the mutual written consent of the parties. On July 19, 2018, the Company and BPC entered into an
amendment to the 2017 Plasma Purchase Agreement to, among other things, provide agreed upon amounts of normal source plasma to be supplied by BPC to ADMA BioManufacturing in calendar year 2019 at a specified price per liter, provided that ADMA
BioManufacturing delivers a valid purchase order to BPC. Additionally, pursuant to the amendment to the 2017 Plasma Purchase Agreement, BPC agreed that, for calendar years 2020 and 2021, it shall supply no less than a high double-digit percentage
of ADMA BioManufacturing’s requested NSP amounts, provided that such requested NSP amounts are within an agreed range, at a price per liter to be mutually determined. Furthermore, pursuant to the amendment to the 2017 Plasma Purchase Agreement,
in the event BPC fails to supply ADMA BioManufacturing with at least a high double-digit percentage of ADMA BioManufacturing’s requested NSP amounts, BPC shall promptly reimburse ADMA BioManufacturing the difference in price ADMA BioManufacturing
incurs due to BPC’s election not to supply NSP to ADMA BioManufacturing in such amounts as requested. On December 10, 2018, BPC assigned its rights and obligations under the Plasma Purchase Agreement to Grifols, effective January 1, 2019.
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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2022 AND 2021
Effective as of May 12, 2021, the Company and Grifols
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. The 2017 Plasma Purchase Agreement expired on
December 31, 2022 and was not renewed. 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. The Company has also increased its
number of planned plasma collection center buildouts such that the Company expects to have ten FDA-approved plasma collection
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
In connection with the FDA approval of the BLA for BIVIGAM on December 19, 2012, Biotest committed to perform two additional
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
BIVIGAM-treated patients with primary humoral immunodeficiency. The Pediatric study for BIVIGAM has been completed, and the safety study is still pending completion. ADMA has assumed the remaining obligations, and the costs of the studies will be
expensed as incurred as research and development expenses. 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. The Company currently expects to incur expenses of
approximately $ 2.0 million to complete these studies, with both studies anticipated to be completed by June of 2023.
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. 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. The Company expects
to incur expenses of approximately $ 1.5 million to complete this study, which is required to be completed by June of 2023.
Employment Contracts
The Company has entered into employment agreements with Mr. Grossman and Mr. Lenz.
Other Commitments
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
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. The
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. The retention awards were granted considering the nationwide labor
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.
The cash portion of the retention program consisted of two tranches. The first tranche was paid to employees on September 30, 2021 in the amount of $ 1.3
million, and the second tranche aggregating to approximately $ 1.3 million was paid on June 15, 2022. Based on the terms of the
retention agreements the Company entered into with each applicable executive and employee, approximately $ 0.8 million of each tranche
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.
In the normal course of business, the Company enters into contracts that contain a variety of indemnifications with its employees, licensors, suppliers and service
providers. Further, the Company indemnifies its directors and officers who are, or were, serving at the Company’s request in such capacities. The Company’s maximum exposure under these arrangements is unknown as of December 31, 2022. The
Company does not anticipate recognizing any significant losses relating to these arrangements.
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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2022 AND 2021
11.
INCOME TAXES
A reconciliation of income taxes at the U.S. federal statutory rate to the benefit for income taxes is as follows:
Year Ended December 31,
2022
2021
Benefit at U.S. federal statutory rate
$
( 13,839,830
)
$
( 15,045,999
)
State taxes - deferred
( 1,773,349
)
( 251,839
)
Increase in valuation allowance
15,117,100
14,618,762
Research and development credits
( 211,343
)
( 239,585
)
Decrease in federal net operating loss
-
623,679
162(m) disallowance
862,027
63,515
Other
( 154,605
)
231,467
Benefit for income taxes
$
-
$
-
A summary of the Company’s deferred tax assets is as follows:
Year Ended December 31,
2022
2021
Federal and state net operating loss carryforwards
$
81,526,316
$
73,036,983
Federal and state research credits
407,280
31,333
Interest expense limitation carryforwards
12,194,369
6,013,040
Transaction costs
881,782
977,046
Deferred revenue
479,510
519,819
Accrued expenses and other
1,236,128
1,030,064
Total gross deferred tax assets
96,725,385
81,608,285
Less: valuation allowance for deferred tax assets
( 96,725,385
)
( 81,608,285
)
Net deferred tax assets
$
-
$
-
As of December 31, 2022, the Company had federal and state (post-apportioned
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
to such time. 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.
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. If the Company is limited in its ability to use its NOLs in future years in which it
has taxable income, then the Company will pay more taxes than if it were otherwise able to fully utilize its NOLs. The Company may experience ownership changes in the future as a result of subsequent shifts in ownership of the Company’s capital
stock that the Company cannot predict or control that could result in further limitations being placed on the Company’s ability to utilize its federal NOLs. As of December 31, 2022, the Company performed a preliminary analysis of limitations
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.
As of December 31, 2021, the Company performed an analysis of limitations imposed
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. 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. When determining the amount of net
deferred tax assets that are more likely than not to be realized, the Company assesses all available positive and negative evidence. This evidence includes, but is not limited to, prior earnings history, expected future earnings, carry-back and
carry-forward periods and the feasibility of ongoing tax strategies that could potentially enhance the likelihood of the realization of a deferred tax asset. The weight given to the positive and negative evidence is commensurate with the extent
the evidence may be objectively verified. As such, it is generally difficult for positive evidence regarding projected future taxable income, exclusive of reversing taxable temporary differences, to outweigh objective negative evidence of recent
financial reporting losses. Based on these criteria and the relative weighting of both the positive and negative evidence available, management continues to maintain a full valuation allowance against its net deferred tax assets.
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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2022 AND 2021
In accordance with U.S. GAAP, the Company is required to determine whether a tax position of the Company is more likely than not to be
sustained upon examination by the applicable taxing authority, including resolution of any related appeals or litigation processes, based on the technical merits of the position. The tax benefit to be recognized is measured as the largest amount
of benefit that is greater than fifty percent likely of being realized upon ultimate settlement. Derecognition of a tax benefit previously recognized could result in the Company recording a tax liability that would reduce net assets. The amount
of the liability for which an exposure exists is measured as the largest amount of benefit determined on a cumulative probability basis that the Company believes is more likely than not to be realized upon ultimate settlement of the position.
Components of the liability are classified as either a current or a long-term liability in the accompanying consolidated balance sheets based on when the Company expects each of the items to be settled. The Company does no t have any unrecognized tax benefits as of December 31, 2022 and 2021 and does not anticipate a significant change in unrecognized tax benefits
during the next 12 months.
12.
LEASE OBLIGATIONS
The Company leases certain properties and equipment for its ADMA BioCenters and ADMA BioManufacturing subsidiaries, 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. The Company’s lease agreements do not contain any material residual value guarantees or material
restrictive covenants.
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. 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 liabilities representing the obligation to make lease payments arising from the lease. 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 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. For the lease liabilities recognized during the years ended December 31, 2022 and 2021, the Company used
discount rates of 13 % to 14 %
to determine the present value of its lease obligations. 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 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. Aggregate cash
paid on these leases for the years ended December 31, 2022 and 2021 was $ 1.8 million and $ 1.4 million, respectively.
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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2022 AND 2021
During the year ended December
31, 2022, the Company recognized additional right-to-use assets and corresponding lease liabilities aggregating to approximately $ 4.0
million in connection with two new property leases where the Company has opened additional plasma collection facilities, a
property lease for the storage of raw materials inventory and a property lease for the building that the Company utilizes as its corporate headquarters (see Note 9). During the year ended December 31, 2021, the Company recognized 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 additional plasma collection facilities. Including a finance lease the Company entered into
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. The
Company’s operating leases have a weighted average remaining term of 8.4 years. Scheduled payments under the Company’s lease
obligations are as follows:
Year ended December 31, 2023
$
2,367,057
2024
2,343,314
2025
2,366,432
2026
2,116,036
2027
2,040,690
Thereafter
8,238,571
Total payments
19,472,100
Less: imputed interest
( 7,862,555
)
Current portion
( 905,369
)
Balance at December 31, 2022
$
10,704,176
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
of 2023. The current monthly payment for this lease is approximately $ 10,000 . The Company intends to renew the lease for an additional
five years in accordance with the terms of the lease, however no renewal agreement has been finalized.
13.
SEGMENTS
The Company is engaged in manufacturing, marketing and developing specialty plasma-derived biologics. The Company’s ADMA BioManufacturing
segment reflects the Company’s immune globulin manufacturing and development operations in Florida, acquired on June 6, 2017. The Plasma Collection Centers segment consists of ten plasma collection facilities as of December 31, 2022, nine of which were
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
immunization program). The Corporate segment includes general and administrative overhead expenses. The Company defines its segments as those business units whose operating results are regularly reviewed by the chief operating decision maker
(“CODM”) to analyze performance and allocate resources. The Company’s CODM is its President and Chief Executive Officer. Summarized financial information concerning reportable segments is shown in the following tables:
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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2022 AND 2021
Year Ended December 31, 2022
ADMA
BioManufacturing
Plasma Collection
Centers
Corporate
Consolidated
Revenues
$
144,069,543
$
9,867,315
$
142,834
$
154,079,692
Cost of product revenue
108,881,938
9,932,597
-
118,814,535
Income (loss) from operations
879,387
( 17,908,378
)
( 22,336,089
)
( 39,365,080
)
Interest and other expense, net
( 504,787
)
( 3,266
)
( 19,360,876
)
( 19,868,929
)
Loss on extinguishment of debt
-
-
( 6,669,941
)
( 6,669,941
)
Net income (loss)
374,600
( 17,911,644
)
( 48,366,906
)
( 65,903,950
)
Capital expenditures
5,246,860
8,664,311
-
13,911,171
Depreciation and amortization expense
4,708,879
2,403,572
918
7,113,369
Total assets
238,159,534
37,070,535
73,231,812
348,461,881
Year Ended December 31, 2021
ADMA
BioManufacturing
Plasma Collection
Centers
Corporate
Consolidated
Revenues
$
74,935,528
$
5,864,263
$
142,834
$
80,942,625
Cost of product revenue
74,124,999
5,644,342
-
79,769,341
Loss from operations
( 29,293,309
)
( 12,056,364
)
( 17,024,068
)
( 58,373,741
)
Interest and other expense, net
( 218,053
)
( 5,660
)
( 13,050,164
)
( 13,273,877
)
Net loss
( 29,511,362
)
( 12,062,024
)
( 30,074,232
)
( 71,647,618
)
Capital expenditures
4,876,983
8,634,275
-
13,511,258
Depreciation and amortization expense
4,217,771
1,272,397
5,334
5,495,502
Total assets
208,391,019
24,681,691
43,180,014
276,252,724
14.
OTHER EMPLOYEE BENEFITS
The Company sponsors a 401(k) savings plan. Under the plan, employees may make contributions which are eligible for a Company
discretionary percentage contribution as defined in the plan and determined by the Board of Directors. The Company recognized $ 1.3
million and $ 1.1 million of related compensation expense for the years ended December 31, 2022 and 2021, respectively.
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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2022 AND 2021
15.
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION
Supplemental cash flow information for the years ended December 31, 2022 and 2021 is as follows:
2022
2021
SUPPLEMENTAL CASH FLOW INFORMATION:
Cash paid for interest
$
13,879,958
$
11,159,461
Noncash Financing and Investing Activities:
Equipment acquired reflected in accounts payable and accrued liabilities
$
1,494,916
$
1,352,627
Right-to-use assets in exchange for lease obligations
$
4,048,099
$
3,554,473
Warrants issued in connection with notes payable
$
9,569,604
$
-
16.
CONCENTRATIONS
Financial instruments that potentially subject the Company to concentrations of credit risk consist of cash and cash equivalents and
accounts receivable. 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.
For the year ended December 31, 2022, two
customers accounted for approximately 74 % of the Company’s consolidated revenues. For the year ended December 31, 2021, four customers accounted for approximately 81 % of the Company’s consolidated revenues.
During the years ended December 31, 2022 and 2021, plasma purchases from Grifols totaled approximately $ 47.7 million and $ 42.0 million,
respectively, or approximately 65 % and 69 %, respectively, of the Company’s total inventory purchases.
Net revenues according to geographic
area, based on the location of where the product is shipped, is as follows:
Year Ended December 31,
2022
2021
United States
$
146,426,617
$
70,625,848
International
7,653,075
10,316,777
Total revenues
$
154,079,692
$
80,942,625
17.
SUBSEQUENT EVENTS
On March 22, 2023, the Company and Hayfin entered into an amendment to the Hayfin Credit Agreement whereby the lenders’ obligation to
make the Hayfin Delayed Draw Loan (see Note 7) was extended to June 30, 2023.
F-23
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.