AMPH Inks License with Nanjing Anji — Up to $267M in Milestones

Rhea-AI Filing Summary

Amphastar Pharmaceuticals entered a license agreement with Nanjing Anji Biotechnology granting Amphastar exclusive rights in the United States and Canada to develop, make, use and commercialize products incorporating certain compounds, including three identified Licensed Products. Amphastar paid an $0.75 million earnest payment and a $5.25 million upfront fee on signing and agreed to up to $42 million in development milestones and up to $225 million in sales milestones, plus royalty payments capped at $22.5 million per product per year and a $60 million accumulated cap per product. Amphastar will share a percentage of sublicense income with Anji, and Anji will pay Amphastar royalties on net sales tied to Amphastar-licensed patents outside the Territory.

The agreement term runs product-by-product and region-by-region to the tenth anniversary of first commercial sale with an Amphastar option to extend up to ten additional years or until patent claims lapse. The company disclosed customary forward-looking statements and identified risks including regulatory approval, commercialization success, legal and regulatory changes, and supply-chain disruptions, and incorporated the full Agreement by reference to be filed as an exhibit.

Positive

• Exclusive U.S. and Canada rights to develop and commercialize specified compounds, including three identified Licensed Products
• Upfront and earnest payments are limited to $5.25M and $0.75M, respectively, giving Amphastar immediate control in the Territory
• Large upside through contingent payments: up to $42M in development milestones and up to $225M in sales milestones
• Royalty payment caps limit annual and lifetime royalty exposure to $22.5M per year and $60M accumulated per product, respectively
• Sublicense income sharing provides an additional revenue pathway tied to any sublicensing transactions

Negative

• Significant contingent cash obligations (up to $42M development and $225M sales milestones) that Amphastar must pay upon achievement of milestones
• Commercial and regulatory risks explicitly identified, including potential failure to obtain regulatory approval and inability to commercialize Licensed Products
• Incomplete public disclosure in the summary; full Agreement terms (e.g., detailed royalty rates, termination rights, and milestones) are not yet filed and are only incorporated by reference
• Long-term obligations tied to product-by-product terms with possible extensions up to ten additional years could prolong liabilities

Insights

Financial Analyst

TL;DR: Exclusive U.S./Canada license with modest upfront, significant contingent payments; creates revenue upside and predictable milestone obligations.

The Agreement provides Amphastar exclusive commercialization rights in the U.S. and Canada for specified compounds, anchoring potential future product revenue streams. The $5.25M upfront and are near-term cash outflows followed by contingent obligations that could total $42M in development and $225M in sales milestones; royalties are capped at $22.5M per product annually and $60M accumulated per product. From a financial standpoint, the structure shifts a portion of commercialization risk to milestone-based payments, linking cash needs to development and sales outcomes. Investors should note the explicit payment caps and sublicense sharing, which define both upside and cost exposure.

M&A / Licensing Specialist

TL;DR: Material exclusive territory rights plus extension option create a long commercialization runway but establish multi-year contingent obligations.

The deal’s territorial exclusivity for Amphastar in the U.S. and Canada, combined with a product-by-product, region-by-region term tied to first commercial sale and a possible ten-year extension, secures a long window for market exploitation. The inclusion of sublicense income sharing and reciprocal royalty obligations for Anji on Amphastar-licensed patents outside the Territory indicates bilateral commercial opportunities. The Company’s statement that the full Agreement will be filed as an exhibit is important for complete diligence because the summary limits visibility into covenants, termination rights, and detailed royalty formulas.

0001297184false00012971842025-08-082025-08-08

​

​

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

​

​

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

​

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

​

Amphastar Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Charter)

​

​

​	​	​
Delaware	001-36509	33-0702205
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(I.R.S. Employer Identification Number)

​

​

​	​
11570 6th Street	​
Rancho Cucamonga, California	91730
(Address of Principal Executive Offices)	(Zip Code)

​

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

​

​

​

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:

​

☐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))

​

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

​

T	​	​	​	​	​	​
Title of each class	​	Trading Symbol(s)	​	Name of each exchange on which registered
​	​		​		​
Common Stock, par value $0.0001 per share	​	AMPH	​	The Nasdaq Stock Market LLC
​	​	​	​	​	​	​

​

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 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 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).

​

​

​

​

​

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
​	By:	/S/WILLIAM J. PETERS
	​	William J. Peters
	​	Chief Financial Officer, Executive Vice President and Treasurer
	​

​

​

​

​

FAQ

What did Amphastar (AMPH) agree to with Nanjing Anji Biotechnology?

Amphastar obtained an exclusive license for the U.S. and Canada to develop, make, use and commercialize certain compounds, including three identified Licensed Products.

How much did Amphastar pay up front in the AMPH license agreement?

Amphastar paid an $0.75 million earnest payment and an $5.25 million upfront payment upon signing.

What are the maximum milestone and royalty obligations under the agreement?

Amphastar may pay up to $42 million in development milestones and up to $225 million in sales milestones, plus royalties capped at $22.5 million per product per year and $60 million accumulated per product.

Will Amphastar receive any payments from Anji under the deal?

Yes. Anji will pay Amphastar royalties on net sales of Licensed Products that are based on patents licensed by Amphastar to Anji outside the Territory.

How long does the license term last under the AMPH agreement?

The term runs product-by-product and region-by-region to the tenth anniversary of the first commercial sale in the applicable region, with Amphastar able to extend up to ten additional years or until relevant patent claims lapse.