Amphastar Pharma Stock Price, News & Analysis

Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) is a biopharmaceutical company in the pharmaceutical preparation manufacturing sector. According to the company’s disclosures and press releases, Amphastar focuses primarily on developing, manufacturing, marketing, and selling technically challenging generic and proprietary injectable, inhalation, and intranasal drug products. In addition, the company sells insulin active pharmaceutical ingredient (insulin API) products.

Amphastar states that many of its finished pharmaceutical products are used in hospital and urgent care clinical settings. These products are primarily contracted and distributed through group purchasing organizations and drug wholesalers, reflecting a business model centered on supplying institutional healthcare channels. The company’s common stock trades on the Nasdaq Stock Market under the ticker symbol AMPH.

Business focus and product portfolio

Across multiple investor and earnings communications, Amphastar describes itself as a company focused on complex generic and proprietary injectable, inhalation, and intranasal products. The company highlights commercial products and brands such as BAQSIMI®, Primatene MIST®, REXTOVY®, Amphadase®, and Cortrosyn®, which it identifies as trademarks or service marks owned by Amphastar. The company also reports having multiple peptide and protein products commercialized in the U.S. market and under development.

Amphastar has disclosed that it manufactures all of its drug products in the United States and manufactures active pharmaceutical ingredients in the United States, China, and France. The company notes that many injectable finished products are used in hospital or urgent care settings, while certain inhalation products are sold in retail pharmacies. Insulin API products are an additional part of its offering, reflecting a role in both finished dosage forms and active ingredient supply.

Strategic emphasis on proprietary and peptide-based medicines

In recent communications, Amphastar has stated that the development of proprietary medicines has become a major strategic direction for the company. It reports building a growing proprietary peptide portfolio and has entered into licensing and research agreements to expand this pipeline.

For example, Amphastar announced an exclusive license agreement with Nanjing Anji Biotechnology Co., Ltd. for three proprietary peptide products. According to the company, these licensed products are intended for use in oncology and ophthalmology indications and are part of a broader effort to expand its proprietary peptide pipeline. Amphastar also disclosed a contract research agreement with Nanjing Hanxin Pharmaceutical Technology Co., Ltd. under which Hanxin develops recombinant peptide research cell banks (RCBs) for one of Amphastar’s product candidates, AMP-107, with Amphastar receiving an exclusive, perpetual license to use those RCBs.

In another transaction, Amphastar entered into an exclusive license agreement with Nanjing Hanxin Pharmaceutical Technology Co., Ltd. for a fully synthetic and highly purified human adrenocorticotropic hormone (ACTH) analog, designated AMP-110, intended for inflammatory and autoimmune conditions. The company describes AMP-110 as part of its proprietary peptide portfolio and notes that the compound is in early-phase human clinical development.

Complex generics and regulatory milestones

Amphastar regularly reports on the development and approval of complex generic products. The company announced that the U.S. Food and Drug Administration approved its Abbreviated New Drug Application (ANDA) for Iron Sucrose Injection, USP, in multiple vial strengths. Amphastar describes this product as a generic iron sucrose injection indicated for the treatment of iron deficiency anemia in patients with chronic kidney disease, and notes that the FDA determined the product meets criteria for bioequivalence and therapeutic equivalence to a reference listed drug.

The company also discloses that it has multiple ANDAs and biosimilar candidates filed with the U.S. FDA, as well as additional biosimilar and generic products in development. Amphastar states that these filings and development programs target products with substantial aggregate market sizes, based on third-party market data, and that it is developing multiple proprietary products with injectable and intranasal dosage forms.

Manufacturing footprint and supply relationships

Amphastar reports that it manufactures all of its finished drug products in the United States, while manufacturing APIs in the United States, China, and France. The company has also described a multi-year plan to significantly expand manufacturing capacity at its headquarters in Rancho Cucamonga, California, characterizing this as a major domestic infrastructure investment intended to increase production capacity and support its research and development pipeline.

Several SEC filings describe manufacturing and distribution agreements with related-party entities affiliated with Nanjing Hanxin Pharmaceutical Technology Co., Ltd. These include amendments to manufacturing and distribution agreements that expand territories for certain products such as lidocaine, corticotropin, and semaglutide-related products, and clarify intellectual property and liability terms. Amphastar’s Audit Committee has reviewed and approved these related-party agreements, according to the company’s 8-K disclosures.

Distribution, markets, and channels

Based on company statements, Amphastar’s finished products are primarily distributed through group purchasing organizations and drug wholesalers, reflecting a focus on institutional and clinical settings. The company has also entered into a distribution agreement with Nanjing Chengong Pharmaceutical Co., Limited, a subsidiary of Hanxin, appointing Chengong as the exclusive distributor to market and sell BAQSIMI® in Mainland China, Taiwan, Hong Kong, and Macau. Under this agreement, Chengong is responsible for obtaining regulatory approvals and conducting post-marketing clinical trials in the region, with minimum purchase obligations and a profit-sharing structure above a defined floor price per unit.

In addition to these arrangements, Amphastar’s public filings and press releases indicate that the company’s business presence includes the United States, China, and France, with the United States accounting for a majority of its revenue according to prior descriptions of its geographic segments.

Research, development, and pipeline

Amphastar’s disclosures emphasize ongoing research and development activities across complex generics, biosimilars, and proprietary products. The company reports:

• Multiple ANDAs filed with the FDA.
• A biosimilar insulin candidate filed with the FDA and additional biosimilar products in development.
• Proprietary peptide and protein products in oncology and ophthalmology, licensed from Anji.
• Development of proprietary products with injectable and intranasal dosage forms.
• Use of recombinant peptide research cell banks for product candidates such as AMP-107.

The company also notes that it uses non-GAAP financial measures, such as adjusted non-GAAP net income and adjusted non-GAAP diluted EPS, to supplement its GAAP financial reporting when discussing financial performance and to support internal forecasting and budgeting.

Capital markets and corporate profile

Amphastar’s common stock is listed on the Nasdaq Stock Market under the symbol AMPH. The company files periodic and current reports with the U.S. Securities and Exchange Commission, including Forms 10-K, 10-Q, and 8-K, which disclose material agreements, financial results, and corporate governance matters. For example, the company has reported:

• Quarterly financial results, including net revenues and net income for recent quarters.
• A share repurchase program authorized by its Board of Directors, intended in part to offset dilution from equity compensation programs.
• Board-level changes, such as the appointment of additional independent directors.

Amphastar also participates in healthcare and investor conferences, including events hosted by J.P. Morgan, Piper Sandler, Jefferies, and Wells Fargo. In its announcements, the company typically reiterates its focus on complex generics, proprietary injectable, inhalation, and intranasal products, and insulin API products, as well as its emphasis on proprietary pipeline growth.

Use cases for investors and researchers

Investors and researchers examining AMPH stock may focus on several aspects of Amphastar’s business as described in its public communications:

• The balance between generic and proprietary products, including complex generics such as iron sucrose injection and proprietary peptide-based therapies.
• The company’s manufacturing footprint in the U.S., China, and France, and its plans to expand domestic capacity.
• Its distribution channels through group purchasing organizations, wholesalers, and regional distribution partners.
• The pipeline of ANDAs, biosimilars, and proprietary candidates, and related licensing and research agreements.
• Related-party arrangements with entities affiliated with Hanxin, as described in multiple 8-K filings and proxy materials.

FAQs about Amphastar Pharmaceuticals, Inc. (AMPH)

Q: What does Amphastar Pharmaceuticals, Inc. do?
A: Amphastar describes itself as a biopharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically challenging generic and proprietary injectable, inhalation, and intranasal products. The company also sells insulin API products, and many of its finished products are used in hospital or urgent care clinical settings and distributed through group purchasing organizations and drug wholesalers.

Q: On which exchange does AMPH trade?
A: Amphastar Pharmaceuticals, Inc. states in its press releases that its common stock trades on the Nasdaq Stock Market under the ticker symbol AMPH.

Q: What types of products are in Amphastar’s portfolio?
A: The company reports a portfolio that includes complex generic and proprietary injectable, inhalation, and intranasal products, as well as insulin API products. Amphastar identifies trademarks such as BAQSIMI®, Primatene MIST®, REXTOVY®, Amphadase®, and Cortrosyn® as belonging to the company.

Q: How does Amphastar describe its strategic focus?
A: Amphastar states that in recent years the development of proprietary medicines has been a major strategic direction. It highlights a growing proprietary peptide pipeline, including licensed peptide products targeting oncology and ophthalmology, and proprietary candidates such as AMP-110 and AMP-107.

Q: Where does Amphastar manufacture its products?
A: According to 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.

Q: In which settings are Amphastar’s products typically used?
A: Amphastar reports that many of its injectable finished products are used in hospital or urgent care settings, while some inhalation products are sold in retail pharmacies. Distribution is primarily through group purchasing organizations and drug wholesalers.

Q: What recent regulatory milestones has Amphastar reported?
A: The company has announced FDA approval of its ANDA for Iron Sucrose Injection, USP, which it describes as a generic iron sucrose injection indicated for iron deficiency anemia in chronic kidney disease. Amphastar also reports multiple ANDAs and a biosimilar insulin candidate filed with the FDA, as well as additional biosimilar and generic products in development.

Q: Does Amphastar have any notable licensing or research agreements?
A: Yes. Amphastar has disclosed an exclusive license agreement with Nanjing Anji Biotechnology Co., Ltd. for three proprietary peptide products, and an exclusive license agreement with Nanjing Hanxin Pharmaceutical Technology Co., Ltd. for AMP-110, a fully synthetic ACTH analog. It has also entered into a contract research agreement with Hanxin for the development of recombinant peptide research cell banks for AMP-107.

Q: How does Amphastar describe its pipeline?
A: The company states that it has several ANDAs and a biosimilar insulin candidate filed with the FDA, additional biosimilar products in development, and multiple proprietary products with injectable and intranasal dosage forms under development. It also highlights proprietary peptide and protein products in oncology and ophthalmology through its agreement with Anji.

Q: What is Amphastar’s relationship with Hanxin and its affiliates?
A: Amphastar’s SEC filings explain that certain executives and their family members beneficially own a majority of the equity interest in Nanjing Hanxin Pharmaceutical Technology Co., Ltd. and its affiliates. As a result, licensing, manufacturing, distribution, and research agreements with Hanxin and its subsidiaries are treated as related-party transactions and are reviewed and approved by the independent and disinterested members of Amphastar’s Audit Committee.

Q: Does Amphastar use non-GAAP financial measures?
A: In its earnings releases, Amphastar discloses non-GAAP financial measures such as adjusted non-GAAP net income and adjusted non-GAAP diluted EPS. The company states that these measures are used internally for forecasting, budgeting, and assessing operating performance, and provides reconciliations to the most directly comparable GAAP measures in its financial tables.