Amphastar Pharmaceuticals Inc. filed SEC Form 8-K: Entry into a Material Definitive Agreement, Regulation FD Disclosure, Financial Statements and Exhibits
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Item 1.01. Entry into a Material Definitive Agreement.
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
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.
Item 7.01. Regulation FD Disclosure
On August 12, 2025, the Company issued a press release announcing the Agreement.
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.
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.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits
Exhibit |
| 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). |
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.
| AMPHASTAR PHARMACEUTICALS, INC. | ||
Date: August 12, 2025 |
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By: | /S/WILLIAM J. PETERS |
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| William J. Peters | ||
| Chief Financial Officer, Executive Vice President and Treasurer | ||
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