UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 5.02 | Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. |
On July 29, 2022, the Board of Directors (the “Board”) of Amneal Pharmaceuticals, Inc. (the “Company”) appointed Deborah M. Autor to the Company’s Board. Ms. Autor will serve on the Board until the Company’s 2023 annual meeting of stockholders and until her earlier death, resignation successor is duly elected and qualified. The Board affirmatively determined that Ms. Autor is independent under the applicable rules and regulations of the Securities and Exchange Commission (the “SEC”) and the listing standards of the New York Stock Exchange. Ms. Autor will also serve on the Board’s Conflicts Committee.
From 2019-2021, Ms. Autor was Global Head of Regulatory Excellence at AstraZeneca, where she led regulatory operations, policy and intelligence for AstraZeneca submissions globally. Before joining AstraZeneca, Ms. Autor served at Mylan N.V. from 2013-2019, where she was Head of Strategic Global Quality and Regulatory Policy and Head of Global Quality, where she led Mylan’s largest function globally (5,000 people), overseeing the quality of 60 billion doses of medicine annually. Ms. Autor was a senior leader at the Food and Drug Administration (“FDA”) from 2001-2013, most recently as Deputy Commissioner for Global Regulatory Operations and Policy where she oversaw all FDA inspections, criminal investigations and international operations for human and veterinary drugs, biologics, medical devices, tobacco and food. Before that, Ms. Autor served as Director of the Office of Compliance of the Center for Drug Evaluation and Research, leading enforcement and policy making for compliance with all drug requirements, including, drug approval; current good manufacturing practices (GMP); human subject protection and bioresearch monitoring (GCP); import and export; and recalls. Before joining FDA, Ms. Autor was a Trial Attorney in the Office of Consumer Litigation of the U.S. Department of Justice, where she litigated civil and criminal cases on behalf of the FDA. Ms. Autor received a Juris Doctor, Magna Cum Laude, from Boston University School of Law and a Bachelor of Arts in Psychology from Columbia University, Barnard College.
Ms. Autor will participate in all non-employee director compensation and benefit programs in which the Company’s other non-employee directors participate pursuant to the Company’s Non-Employee Director Compensation Policy.
There are no arrangements or understandings between Ms. Autor and any other persons pursuant to which she was appointed as a member of the Board. There are no family relationships between Ms. Autor and any director, executive officer or any other person nominated or chosen by the Company to become a director or executive officer. There are no related party transactions involving (within the meaning of Item 404(a) of Regulation S-K promulgated by the SEC) between Ms. Autor and the Company.
| Item 7.01 | Regulation FD Disclosure. |
A copy of the Company’s press release regarding the matters described above has been furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this report furnished pursuant to Item 7.01, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. It may only be incorporated by reference in another filing under the Exchange Act or the Securities Act of 1933, as amended, if such subsequent filing specifically references the information furnished pursuant to Item 7.01 of this report.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit |
Description of Exhibit | |
| 99.1 | Press Release, dated August 3, 2022. | |
| 104 | Cover Page Interactive Data File - the cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: August 3, 2022 | AMNEAL PHARMACEUTICALS, INC. | |||||
| By: | /s/ Jason B. Daly | |||||
| Name: | Jason B. Daly | |||||
| Title: | Chief Legal Officer & Corporate Secretary | |||||
Exhibit 99.1
Amneal Appoints Deborah M. Autor to Board of Directors
- Adds new independent director with deep biopharmaceutical industry expertise in quality, regulatory and policy
August 3, 2022
BRIDGEWATER, N.J. – Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that Deborah M. Autor has been appointed to the Company’s Board of Directors, effective July 29, 2022.
Chirag and Chintu Patel, Co-Chief Executive Officers, stated, “Deb brings decades of global public and private expertise in the biopharmaceutical sector to our board at an important time of growth for Amneal. She has a proven track record of service and impact throughout her distinguished career in quality, regulatory, and policy. We are delighted to welcome Deb to the board and look forward to working closely with her as we execute our strategy and expand our business into new and more complex high growth areas.”
Most recently, Ms. Autor held global quality and regulatory leadership roles at AstraZeneca and Mylan N.V. From 2019 to 2021, Ms. Autor was Global Head of Regulatory Excellence at AstraZeneca, where she led regulatory operations, policy and intelligence for their submissions globally. Prior to that, Ms. Autor was at Mylan N.V. from 2013 to 2019, where she was Head of Strategic Global Quality and Regulatory Policy and Head of Global Quality. Prior to her leadership within the industry, she served at the U.S. Food and Drug Administration (“FDA”) for over a decade, including as Deputy Commissioner for Global Regulatory Operations and Policy where she oversaw all FDA inspections, criminal investigations and international operations for human and veterinary drugs, biologics, medical devices, tobacco and food. Before that, Ms. Autor served as Director of the Office of Compliance of the Center for Drug Evaluation and Research, leading enforcement and policymaking for compliance with all drug requirements, including, drug approval; current good manufacturing practices (GMP); human subject protection and bioresearch monitoring (GCP); import and export; and recalls. During her time at the FDA, she won several public service awards. Before joining the FDA, Ms. Autor was a Trial Attorney in the Office of Consumer Litigation of the U.S. Department of Justice, where she litigated civil and criminal cases on behalf of the FDA. She received a Juris Doctor, Magna Cum Laude, from Boston University School of Law and a Bachelor of Arts in Psychology from Columbia University, Barnard College. Ms. Autor also has diverse board experience, including currently serving as a Board Director for Pardes Biosciences, Inc. and Chair of Board for the FDA Alumni Association.
As a result of Ms. Autor’s appointment, the Amneal Board will comprise of eleven directors.
About Amneal
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals, primarily within the United States. The Company has a diverse portfolio of over 250 products in its Generics segment and is expanding across a broad range of complex products and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceutical products focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more, please visit www.amneal.com.
Cautionary Statement on Forward-Looking Statements
Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, strategies, beliefs, expectations or forecasts for the future, including among other things: product research and development; discussions of future operations; expected operating results and financial performance, including pro forma results; impact of acquisitions and dispositions, and estimated returns or assumptions underlying acquisitions and dispositions; the Company’s strategy for growth; regulatory approvals and actions; market position, saturation, and expenditures. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates” and similar words are intended to identify estimates and forward-looking statements.
The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company.
Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry in general, including from brand and generic drug product companies, and the impact of that competition on our ability to execute on pricing strategies; our ability to obtain exclusive marketing rights for our products; our ability to manage our growth through acquisitions and otherwise; our dependence on the sales of a limited number of products for a substantial portion of our total revenues; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods and any associated supply chain disruptions; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or curb Amneal’s ability to sell its products; the impact of severe weather; the impact of the ongoing COVID-19 pandemic; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of product liability and other claims against us by consumers and other third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to FDA product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our dependence on third-party agreements for a portion of our product offerings; the impact of global economic conditions, including any economic effects stemming from adverse geopolitical events, an economic downturn and inflation rates; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; our obligations under a tax receivable agreement may be significant; and the high concentration of ownership of our Class A Common Stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent
reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.
Contact
Anthony DiMeo
Head of Investor Relations
anthony.dimeo@amneal.com
Document and Entity Information |
Jul. 29, 2022 |
|---|---|
| Cover [Abstract] | |
| Amendment Flag | false |
| Entity Central Index Key | 0001723128 |
| Document Type | 8-K |
| Document Period End Date | Jul. 29, 2022 |
| Entity Registrant Name | AMNEAL PHARMACEUTICALS, INC. |
| Entity Incorporation State Country Code | DE |
| Entity File Number | 001-38485 |
| Entity Tax Identification Number | 32-0546926 |
| Entity Address, Address Line One | 400 Crossing Blvd |
| Entity Address, City or Town | Bridgewater |
| Entity Address, State or Province | NJ |
| Entity Address, Postal Zip Code | 08807 |
| City Area Code | (908) |
| Local Phone Number | 947-3120 |
| Written Communications | false |
| Soliciting Material | false |
| Pre Commencement Tender Offer | false |
| Pre Commencement Issuer Tender Offer | false |
| Security 12b Title | Class A Common Stock, par value $0.01 per share |
| Trading Symbol | AMRX |
| Security Exchange Name | NYSE |
| Entity Emerging Growth Company | false |
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