0001558370-25-011134.txt : 20250812 0001558370-25-011134.hdr.sgml : 20250812 20250812061042 ACCESSION NUMBER: 0001558370-25-011134 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20250808 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20250812 DATE AS OF CHANGE: 20250812 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Amphastar Pharmaceuticals, Inc. CENTRAL INDEX KEY: 0001297184 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences EIN: 330702205 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36509 FILM NUMBER: 251203920 BUSINESS ADDRESS: STREET 1: 11570 SIXTH STREET CITY: RANCHO CUCAMONGA STATE: CA ZIP: 91730 BUSINESS PHONE: 909-980-9484 MAIL ADDRESS: STREET 1: 11570 SIXTH STREET CITY: RANCHO CUCAMONGA STATE: CA ZIP: 91730 8-K 1 amph-20250808x8k.htm 8-K _
0001297184false00012971842025-08-082025-08-08

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

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CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

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Date of Report (Date of earliest event Reported): August 8, 2025

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Amphastar Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Charter)

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Delaware

001-36509

33-0702205

(State or Other Jurisdiction of
Incorporation)

(Commission File Number)

(I.R.S. Employer Identification
Number)

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11570 6th Street

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Rancho Cucamonga, California

91730

(Address of Principal Executive Offices)

(Zip Code)

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Registrant's telephone number, including area code: (909) 980-9484

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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

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☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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Securities registered pursuant to Section 12(b) of the Act:

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T

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Title of each class

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Trading Symbol(s)

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Name of each exchange on which registered

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Common Stock, par value $0.0001 per share

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AMPH

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The Nasdaq Stock Market LLC

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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).

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Emerging growth company ☐

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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. ☐

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Item 1.01. Entry into a Material Definitive Agreement.

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On August 8, 2025 Amphastar Pharmaceuticals, Inc. (“Amphastar”) and Nanjing Anji Biotechnology Co., Ltd. (“Anji”) entered into a License Agreement (the “Agreement”) pursuant to which Anji is granting an exclusive license to certain intellectual property controlled by Anji to develop, make, use and commercialize products incorporating or comprising certain compounds, including three identified products (“Licensed Products”) in the United States and Canada (the “Territory”). Anji is also granted a non-exclusive license under certain intellectual property controlled by Amphastar to develop, make, use and commercialize Licensed Products outside the Territory. Amphastar made an earnest money payment of $0.75 million and an upfront payment of $5.25 million to Anji upon signing the Agreement. Amphastar is also required to make payments to Anji consisting of up to $42 million in development milestone payments and up to $225 million in sales milestone payments, subject to the achievement of the applicable development and sales milestone events respectively, and royalty payments, not to exceed a maximum annual amount of $22.5 million each calendar year for each Licensed Product and a maximum accumulated amount of $60 million for each Licensed Product. Amphastar will pay to Anji certain percentage of sublicense income received from sublicense transactions. Anji will pay to Amphastar a royalty payment of net sales of Licensed Products that are based on any patents licensed by Amphastar to Anji under the Agreement or regulatory exclusivity covering such Licensed Products. The term of this Agreement will expire, on a Licensed Product-by-Licensed Product and region-by-region basis, on the tenth anniversary of the first commercial sale of such Licensed Product in the applicable region in the Territory, with Amphastar having the right to extend the Agreement until the earlier of ten additional years or the expiration, lapse, or invalidation of the last remaining valid claim of the patents licensed by Anji to Amphastar that covers the Licensed Products in the Territory.

The foregoing is a brief description of the material terms of the Agreement, does not purport to be a complete description of the rights and obligations of the parties thereunder, and is qualified in its entirety by reference to the copy of the Agreement that will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q to be filed with the Securities and Exchange Commission for the fiscal quarter ending September 30, 2025, and is incorporated herein by reference.

Forward-Looking Statements

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All statements in this current report that are not historical are forward-looking statements, including, among other things, statements relating to the performance of the parties under the Agreement and the expected payments thereunder. These statements are not facts but rather are based on Amphastar’s historical performance and our current expectations, estimates, and projections regarding our business, operations, and other similar or related factors. Words such as "may," "might," "will," "could," "would," "should," "anticipate," "predict," "potential," "continue," "expect," "intend," "plan," "project," "believe," "estimate," and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Amphastar’s control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including the failure to receive regulatory approval for the Licensed Products, the inability to successfully commercialize the Licensed Products, changes in laws and regulations and disruptions in supply chains as well as others described in Amphastar’s filings with the Securities and Exchange Commission, including in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 3, 2025, in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 filed with the SEC on May 8, 2025, and in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025 filed with the SEC on August 7, 2025. You can locate these reports through our website at http://ir.amphastar.com and on the SEC's website at www.sec.gov. The forward-looking statements in this current report speak only as of the date of the report. Amphastar undertakes no obligation to revise or update information or any forward-looking statements in this current report to reflect events or circumstances in the future, even if new information becomes available or if subsequent events cause our expectations to change.

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Item 7.01. Regulation FD Disclosure

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On August 12, 2025, the Company issued a press release announcing the Agreement.

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A copy of the press release is being furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

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The information in Item 7.01 of this Current Report on Form 8-K is not deemed to be “filed” for the purpose of Section 18 of the Securities Act of 1933, or the Securities Act of 1934, except as expressly set forth by specific reference in such filing.

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Item 9.01. Financial Statements and Exhibits

(d) Exhibits

 

Exhibit
No.

 

Description

99.1

 

Press Release, dated August 12, 2025 of Amphastar Pharmaceuticals, Inc.

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document).

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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.

 

 

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AMPHASTAR PHARMACEUTICALS, INC.

Date: August 12, 2025

 

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By:

/S/WILLIAM J. PETERS

 

 

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William J. Peters

 

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Chief Financial Officer, Executive Vice President and Treasurer

 

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 EX-99.1 2 amph-20250808xex99d1.htm EX-99.1

Exhibit 99.1

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Amphastar Pharmaceuticals Bolsters Proprietary Pipeline Through Exclusive Licensing Agreement with Nanjing Anji Biotechnology Co., Ltd.

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Agreement strengthens proprietary peptide pipeline targeting high-value oncology and ophthalmology indications

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RANCHO CUCAMONGA, CA – August 12, 2025 – Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) (“Amphastar”), a biopharmaceutical company focused on developing, manufacturing, and marketing complex generic and proprietary injectable, inhalation, and intranasal products, today announced that it has entered into an exclusive license agreement (“Agreement”) with Nanjing Anji Biotechnology Co., Ltd. ("Anji") for the development, manufacturing, use, and commercialization of three proprietary peptides, ("Licensed Products"), in the United States and Canada (“Territory”).

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The first product is based on the discovery by Anji of an endogenous peptide that demonstrates a novel mechanism of action that potentially suppresses the growth and metastasis of multiple poorly treated cancers.

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The second product is a novel peptide-docetaxel conjugate that targets a specific receptor, designed to improve the selectivity and bioavailability of docetaxel. It is designed to reduce docetaxel-induced toxicity, which will improve the efficacy and safety of current taxane therapies.

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The third product is an anti-vascular endothelial growth factor receptor (VEGFR) peptide of novel design, developed as a topical eye drop for the treatment of wet age-related macular degeneration (wAMD). It is intended to be an alternative to the routine eye injections used for current treatment.

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“We are delighted to announce a strategic licensing agreement with Anji, whose cutting edge research and development expertise in peptide and polypeptide therapeutics aligns perfectly with Amphastar’s mission to develop novel, proprietary, and innovative products,” said Dr. Jack Zhang, Amphastar's President and Chief Executive Officer “This collaboration significantly expands our pipeline with three potentially best-in-class peptide assets, targeting high-growth markets across oncology and ophthalmology. We believe this partnership builds upon Amphastar’s legacy in successfully developing and commercializing peptide products and underscores our shared commitment to bringing transformative therapies to patients.”

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Under the terms of the Agreement, Anji grants Amphastar an exclusive license to intellectual property controlled by Anji related to the Licensed Products in the Territory. Additionally, Anji will receive a non-exclusive license from Amphastar for certain intellectual property to develop, make, use, and commercialize Licensed Products outside the Territory.

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Amphastar made an earnest money payment of $0.75 million and an upfront payment of $5.25 million to Anji upon signing the Agreement. The Agreement also includes additional potential development milestone payments of up to $42 million and sales milestone payments of up to $225 million, contingent upon the achievement of certain milestones based on annual net sales.

Furthermore, Amphastar will pay Anji 5% royalty payments on net sales, with a maximum accumulated amount of $60 million for each Licensed Product. Anji will also pay Amphastar low single-digit royalty payments on net sales of Licensed Products based on any patents licensed by Amphastar to Anji under the Agreement. Anji may receive up to $453 million in total payments over the lifetime of the Agreement.

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The term of the Agreement will expire, on a Licensed Product-by-Licensed Product and region-by-region basis, on the tenth anniversary of the first commercial sale of such Licensed Product in the applicable region in the Territory, with Amphastar having the right to extend the Agreement until the earlier of an additional ten years or until the expiration, lapse, or invalidation of the last remaining valid claim of the patents licensed by Anji to Amphastar that cover the Licensed Products in the Territory.

About Amphastar Pharmaceuticals, Inc.

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Amphastar is a biopharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable, inhalation, and intranasal products. In recent years, the development of proprietary medicines has been a major strategic direction for the Company. Amphastar manufactures all of its drug products in the United States, and manufactures active pharmaceutical ingredients in the United States, China and France. Amphastar has multiple peptide and protein products commercialized in the US market and under development. Many of the Company's injectable finished products are used in hospital or urgent care settings while the inhalation products are sold in retail pharmacies. More information and resources are available at www.amphastar.com.

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Amphastar's logo and other trademarks or service marks of Amphastar, including, but not limited to Amphastar®, BAQSIMI®, Primatene MIST®, REXTOVY®, Amphadase®, and Cortrosyn®, are the property of Amphastar.

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About Nanjing Anji Biotechnology Co., Ltd.

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Nanjing Anji Biotechnology Co., Ltd. is a high-tech enterprise located in Nanjing, China, focusing on the research and development of innovative peptide drugs and peptide-drug conjugates. The company possesses key technologies: (i) high-throughput endogenous micropeptide discovery technology (ii) computer-aided peptide drug design technology, along with (iii) a comprehensive preclinical drug evaluation platform.

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Forward-Looking Statements

All statements in this press release referenced above that are not historical are forward-looking statements, including, among other things, statements relating to our expectations regarding the Agreement with Anji including its effects on Amphastar’s pipeline, ability to bring additional products to market, ability to meet customer demand and other future events. These statements are not facts but rather are based on Amphastar’s historical performance and our current

​

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expectations, estimates, and projections regarding our business, operations, and other similar or related factors. Words such as “may,” “might,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expect,” “intend,” “plan,” “project,” “believe,” “estimate,” and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Amphastar’s control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Amphastar’s filings with the Securities and Exchange Commission, including in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 3, 2025, in our Quarterly Report on Form 10-Q for the quarter ending June 30, 2025, filed with the SEC on August 7, 2025. You can locate these reports through our website at http://ir.amphastar.com and on the SEC’s website at www.sec.gov. The forward-looking statements in this release speak only as of the date of the release. Amphastar undertakes no obligation to revise or update information or any forward-looking statements in this press release referenced above to reflect events or circumstances in the future, even if new information becomes available or if subsequent events cause our expectations to change.

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Contact Information:

Amphastar Pharmaceuticals, Inc.
Bill Peters
Chief Financial Officer
(909) 980-9484

​

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