Every 8-K that Amphastar Pharmaceuticals, Inc. (AMPH) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow AMPH and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full AMPH filings page.
Amphastar Pharmaceuticals reported second-quarter 2026 results with net revenues of $183,903 (in thousands), up 5% from the prior-year quarter. Product performance was mixed, with declines in BAQSIMI, Primatene MIST, Epinephrine and Glucagon offset by growth in other products and the launch of Ipratropium bromide. Gross profit rose to $93,470 (in thousands), expanding gross margin to 50.8% from 49.6%.
Operating expenses increased across selling, general and administrative, and R&D, leading to GAAP net income of $30,348 (in thousands) versus $31,030 a year earlier. Diluted EPS was $0.67, while adjusted non-GAAP net income was $40,759 (in thousands) and adjusted diluted EPS was $0.91. For the first six months of 2026, net revenues were $355,074 (in thousands) and GAAP net income was $36,768 (in thousands), compared with $344,942 and $56,315 (in thousands), respectively, with operating cash flow of $99.2 million.
As of June 30, 2026, the company held cash and cash equivalents of $223,614 (in thousands), short-term investments of $66,509 (in thousands), total assets of $1,743,766 (in thousands), and stockholders’ equity of $768,157 (in thousands). The pipeline includes one ANDA and one biosimilar insulin filed with the FDA targeting markets with a combined size exceeding $1.6 billion, plus additional biosimilar and generic candidates aimed at markets exceeding $3.5 billion and over $1.2 billion, respectively.
Amphastar Pharmaceuticals, Inc. increased the size of its Board of Directors from ten to eleven members and appointed Anthony Pierce as a Class III director, effective July 9, 2026. He will serve until the company’s 2028 annual meeting of stockholders, or earlier if he departs.
The Board determined that Mr. Pierce is independent under Nasdaq listing standards and noted there are no related-party arrangements or transactions requiring disclosure. His compensation includes an annual cash retainer of $55,000 (pro-rated for his start date) and an initial equity grant split 50% restricted stock units and 50% stock options with an aggregate grant date fair value of $300,000, vesting on the first anniversary of grant, subject to continued service. He will also enter into the company’s standard indemnification agreement.
Amphastar Pharmaceuticals reported that its subsidiary, International Medication Systems, received an FDA Warning Letter on July 2, 2026 for its drug manufacturing facility in South El Monte, California. The letter follows a December 2025 FDA inspection and cites violations of current Good Manufacturing Practice regulations.
The observations relate to investigation procedures, environmental monitoring and handling procedures, and manufacturing equipment. IMS has not been directed to stop or restrict product from the facility or conduct a further recall, and it continues to manufacture while implementing a remediation plan and risk assessment requested by the FDA.
The company is evaluating the impact on its operations and acknowledges there is no assurance the FDA will be satisfied with its response. Until the deficiencies are resolved to the FDA’s satisfaction, additional regulatory or legal action may be taken without further notice.
Amphastar Pharmaceuticals, Inc. reported results from its annual stockholder meeting. Stockholders elected three directors — David Gaugh, William J. Peters, and Jacob Liawatidewi — to serve until the 2029 annual meeting. They also ratified Ernst & Young LLP as independent auditor for the fiscal year ending December 31, 2026.
Stockholders approved, on a non-binding basis, the compensation of the company’s named executive officers. In a separate advisory vote, stockholders indicated a preference for holding say‑on‑pay votes every year, and the board decided to schedule future advisory votes on executive compensation annually, with the next required frequency vote to occur no later than the 2032 annual meeting.
Amphastar Pharmaceuticals reported first quarter 2026 results showing flat revenue but significantly lower profit. Net revenues were $171.2 million, essentially unchanged from $170.5 million a year earlier, while GAAP net income fell to $6.4 million from $25.3 million. GAAP diluted EPS declined to $0.14 from $0.51, and adjusted non-GAAP diluted EPS decreased to $0.42 from $0.74.
Gross profit dropped to $70.3 million from $85.3 million as gross margin narrowed to 41.1% from 50.0%, reflecting an 18% rise in cost of revenues. Research and development spending increased 33% to $26.7 million and general and administrative expense rose 13% to $18.0 million. Despite lower earnings, cash flow provided by operating activities was $47.8 million.
The company highlighted the approval and launch of Ipratropium Bromide HFA, an exclusive license for a fully synthetic corticotropin compound, and progress across a proprietary and biosimilar pipeline. Current filings include one ANDA and one biosimilar insulin candidate targeting markets over $1.6 billion, plus additional biosimilar and generic programs addressing several billion dollars of estimated market opportunity.
Amphastar Pharmaceuticals reported that its Board of Directors authorized a $50 million increase to the company’s share buyback program, effective March 12, 2026. The program is intended primarily to offset dilution from equity compensation grants over time.
Repurchases may occur over an indefinite period through open-market purchases, private block trades, Rule 10b5-1 plans, privately negotiated deals, or other methods permitted by law. The timing and actual number of shares bought back will depend on the share price, corporate and regulatory requirements, and other conditions.
Amphastar Pharmaceuticals, Inc. reported new executive employment agreements for Jacob Liawatidewi and Rong Zhou effective March 3, 2026. Each agreement has a one-year term that automatically renews unless either party gives 90 days’ notice and can be terminated at any time with or without cause or good reason.
Liawatidewi will receive an annual base salary of $525,800 with a target cash bonus equal to 55% of base salary, while Zhou will receive $590,000 with a 53% target bonus. Both are eligible for equity incentives and standard company benefit plans.
On a qualifying termination, they may receive severance benefits subject to signing a release, with additional severance if it occurs within one year after a change in control. Upon any change in control during employment, 100% of their unvested equity awards will vest. Payments are also structured to address potential Section 280G excise taxes.
Amphastar Pharmaceuticals outlined two agreements with Chinese affiliates that it does not view as material to its financial results. Its subsidiary Amphastar Nanjing Pharmaceuticals signed a five-year supply agreement with Nanjing Letop Biotechnology, under which Letop will provide chemical intermediates. Amphastar can choose order volumes at its discretion and is not required to buy any minimum quantity. Payments will be made in Chinese yuan, and Amphastar retains ownership of shared confidential information.
Separately, Amphastar amended its contract research arrangement with Nanjing Hanxin Pharmaceutical Technology. The company will use Hanxin’s research cell banks to develop Master Cell Banks for product candidate AMP-105 instead of AMP-107. This change increases the total contract cost by about $0.6 million. Both Letop and Hanxin are majority-owned by family members of senior executives, and Amphastar’s Audit Committee reviewed and approved these related party transactions.
Amphastar Pharmaceuticals reported fourth-quarter and full-year 2025 results showing modestly lower sales but a sharp drop in profit. Full-year net revenues were $719,887,000 versus $731,967,000 a year earlier, while GAAP net income declined to $98,094,000 from $159,519,000, and GAAP diluted EPS fell to $2.03 from $3.06.
Adjusted non-GAAP net income decreased to $156,618,000 from $200,806,000, with adjusted diluted EPS of $3.25 compared with $3.86. BAQSIMI® was a key growth driver, with 2025 product revenues of $185,358,000 up from $126,898,000, while glucagon and epinephrine products declined. Operating expenses rose, particularly general and administrative and research and development.
The company generated cash flow from operating activities of $156,100,000 for 2025 and ended the year with cash, cash equivalents, and short-term investments totaling $282,812,000. Amphastar highlighted recent FDA approvals for iron sucrose and teriparatide injections and expanded its proprietary pipeline with three novel peptides and a fully synthetic corticotropin compound targeting oncology, ophthalmology, and immunology markets.
Amphastar Pharmaceuticals entered an exclusive license with Nanjing Hanxin to develop and sell a corticotropin product in the United States and Canada. Amphastar paid an upfront $2 million and may owe up to $14 million in development milestones, up to $75 million in sales milestones, and annual royalties capped at $7.5 million with a lifetime cap of $60 million for this product. Hanxin will pay Amphastar royalties on sales of licensed products that use Amphastar patents or regulatory exclusivity outside this territory.
The license term runs at least ten years from first commercial sale in each region, with an option for Amphastar to extend. Amphastar and Hanxin also expanded their existing distribution and manufacturing agreements to cover additional regions and products, which the company does not consider material to its financial condition or results. These agreements are related-party transactions because Amphastar’s founders and their family beneficially own a majority of Hanxin; the company states its audit committee evaluated and approved the new arrangements.
Amphastar Pharmaceuticals filed an 8-K stating it issued a press release announcing financial results for the three months ended September 30, 2025. The press release is furnished as Exhibit 99.1.
The company notes the furnished information is not deemed “filed” for purposes of Section 18 of the Exchange Act and is not incorporated by reference into other filings unless specifically referenced.
Amphastar Pharmaceuticals entered a Distribution Agreement effective October 21, 2025 with Nanjing Chengong Pharmaceutical to expand sales of BAQSIMI nasal powder across Mainland China, Taiwan, Hong Kong, and Macau. Amphastar appointed Chengong as the exclusive distributor in the Greater China region. Chengong will obtain regulatory approvals and conduct required post‑marketing clinical trials.
The agreement includes minimum purchase amounts per contract year and a profit‑sharing structure on earnings above a floor price per unit, determined using Chengong’s per‑unit net revenue. The term is 10 years, with both parties holding termination rights without cause after the fourth Contract Year. Payments will be in U.S. dollars, and total revenue over the term is not determinable based on the filing. The transaction is a related party arrangement: executives and certain family members beneficially own a majority of Hanxin, Chengong’s parent. The Company’s independent and disinterested Audit Committee members evaluated and approved the agreement.
Amphastar Pharmaceuticals entered into a three-year contract research agreement with Nanjing Hanxin Pharmaceutical Technology effective September 15, 2025. Under this deal, Hanxin will develop Recombinant Peptide Research Cell Banks (RCBs) for Amphastar’s product candidate AMP-107 and license them under a fully paid, exclusive, perpetual, transferable, sub-licensable worldwide license.
All title to the RCBs and related development and manufacturing know-how, including engineering, scientific data, designs, and procedures, will belong to Amphastar. The total cost of the agreement will not exceed approximately $2.8 million, paid in Chinese yuan, including an initial payment of about $0.3 million on the effective date, with any extra work billed on a cost-plus basis subject to prior approval.
The filing notes this is a related-party transaction because Amphastar CEO Dr. Jack Zhang, COO and Chairman Dr. Mary Luo, and certain family members beneficially own a majority of Hanxin’s equity. The independent and disinterested members of the Audit Committee evaluated and approved Amphastar’s entry into the agreement.
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.