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1. Company Snapshot

1.a. Company Description

Amphastar Pharmaceuticals, Inc., a bio-pharmaceutical company, develops, manufactures, markets, and sells generic and proprietary injectable, inhalation, and intranasal products in the United States, China, and France.The company operates through two segments, Finished Pharmaceutical Products and API.It offers Primatene Mist, an over-the-counter epinephrine inhalation product for the temporary relief of mild symptoms of intermittent asthma; Enoxaparin, a low molecular weight heparin to prevent and treat deep vein thrombosis; Naloxone for opioid overdose; Glucagon for injection emergency kit; and Cortrosyn, a lyophilized powder for use as a diagnostic agent in the screening of patients with adrenocortical insufficiency.


The company also provides Amphadase, a bovine-sourced hyaluronidase injection to absorb and disperse other injected drugs; Epinephrine injection for the emergency treatment of allergic reactions; lidocaine jelly, an anesthetic product for urological procedures; lidocaine topical solution for various procedures; phytonadione injection, a vitamin K1 injection for newborn babies; emergency syringe products for emergency use in hospital settings; morphine injection for use with patient controlled analgesia pumps; and lorazepam injection for surgery and medical procedures.In addition, it offers neostigmine methylsulfate injection to treat myasthenia gravis and to reverse the effects of muscle relaxants; and Isoproterenol hydrochloride injection for mild or transient episodes of heart block.Further, the company distributes recombinant human insulin active pharmaceutical ingredients (API) and porcine insulin API.


It serves hospitals, care facilities, alternate care sites, clinics, and doctors' offices.The company was founded in 1996 and is headquartered in Rancho Cucamonga, California.

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1.b. Last Insights on AMPH

Amphastar Pharmaceuticals' recent performance was negatively impacted by a series of setbacks. The company's Q4 earnings missed market expectations, with adjusted EPS of 92 cents, falling short of the consensus estimate of 94 cents. Additionally, Amphastar's margins dropped, contributing to the disappointing results. Furthermore, the company received a secondary complete response letter (CRL) from the FDA for its generic teriparatide ANDA, AMP-015, following months of delays surrounding the submission of the drug. This regulatory hurdle has likely weighed on investor sentiment and may have a lasting impact on the company's growth prospects.

1.c. Company Highlights

2. Amphastar Pharmaceuticals' Q3 2025 Earnings: Strong Execution and Pipeline Expansion

Amphastar Pharmaceuticals reported net revenues of $191.8 million and GAAP net income of $17.4 million, or $0.37 per diluted share, for the third quarter of 2025. On a non-GAAP basis, adjusted net income was $44.7 million, or $0.93 per diluted share, beating analyst estimates of $0.77. The company's financial performance was driven by strong commercial execution, with revenues increasing slightly from $191.2 million in the previous year period. The company's CFO, William Peters, noted that BAQSIMI recorded its highest quarterly sales ever, growing to $53.6 million.

Publication Date: Nov -18

📋 Highlights
  • Net Revenues & Profitability: Amphastar reported $191.8M net revenues, with GAAP net income of $17.4M ($0.37/share) and non-GAAP adjusted net income of $44.7M ($0.93/share).
  • BAQSIMI Growth: BAQSIMI reached $53.6M in sales (+14% YoY), recording its highest quarterly revenue ever due to seasonal demand and expanded sales efforts.
  • In-Licensed Peptide Candidates: Secured U.S./Canadian rights to three early-stage oncology/ophthalmology peptide candidates via an exclusive agreement with Nanjing Anji.
  • Manufacturing Expansion: U.S. manufacturing capacity will quadruple, enhancing operational agility to support portfolio growth and capture higher value.
  • Pipeline & Regulatory Progress: FDA-approved iron sucrose injection expanded patient access, and the company aims for 50% proprietary products in its pipeline by 2026.

Segment Performance

The company's segment performance was a key highlight, with BAQSIMI delivering $53.6 million in sales, up 14% year-over-year, driven by seasonal demand and expanded sales execution. Primatene MIST sales also increased 11% year-over-year, validating consumer engagement in the OTC respiratory space. The company's U.S. manufacturing expansion will quadruple production capacity, strengthening operational agility and positioning the company to capture greater value across its portfolio.

Pipeline Expansion and Regulatory Progress

Amphastar also made significant progress in its pipeline expansion and regulatory initiatives. The company announced an exclusive in-licensing agreement with Nanjing Anji Biotechnology, securing U.S. and Canadian rights to three early-stage novel peptide candidates targeting high-growth markets across oncology and ophthalmology. The company is on track to reach its target of proprietary products comprising 50% of its pipeline by 2026. Regulatory initiatives include the FDA approval of iron sucrose injection, which expands patient access to affordable therapies and contributes to revenue growth.

Valuation and Growth Prospects

With a P/E Ratio of 10.83 and an EV/EBITDA of 8.0, Amphastar's valuation appears reasonable. Analysts estimate next year's revenue growth at 5.1%. The company's guidance suggests flat growth this year and high single-digit to low double-digit growth next year. The company's peak sales forecast for BAQSIMI is $250-275 million, indicating significant growth potential. With a strong track record of execution and a growing pipeline, Amphastar is well-positioned to deliver innovation and value to its shareholders.

Competitive Landscape and Strategy

During the Q&A session, management addressed various topics, including the competitive dynamics of generic Venofer and the potential opportunity for iron sucrose. They expressed excitement about the newly licensed peptide candidates and their potential for broad applications in cancer treatments. The company is also working on a follow-on product for Primatene MIST with a lower global warming propellant and has filed a patent. With a robust manufacturing infrastructure and a growing pipeline, Amphastar is poised to navigate the competitive landscape effectively.

3. NewsRoom

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Amphastar Pharmaceuticals to Present at the 37th Annual Piper Sandler Healthcare Conference

Nov -24

Source: accessnewswire.com

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Amphastar Pharmaceuticals to Present at the Jefferies Global Healthcare Conference

Nov -12

Source: accessnewswire.com

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Amphastar Pharmaceuticals, Inc. (AMPH) Q3 2025 Earnings Call Transcript

Nov -08

Source: seekingalpha.com

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Here's What Key Metrics Tell Us About Amphastar (AMPH) Q3 Earnings

Nov -07

Source: zacks.com

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Amphastar Pharmaceuticals (AMPH) Q3 Earnings and Revenues Top Estimates

Nov -06

Source: zacks.com

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Amphastar Pharmaceuticals Reports Financial Results for the Three Months Ended September 30, 2025

Nov -06

Source: accessnewswire.com

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Amphastar Pharmaceuticals to Release Third Quarter Earnings and Hold Conference Call on November 6th, 2025

Oct -27

Source: accessnewswire.com

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IFP Advisors Inc Buys 877 Shares of Amphastar Pharmaceuticals, Inc. $AMPH

Oct -22

Source: defenseworld.net

4. Business Breakdown

4.a. Revenues by Country

4.b. Revenues by Segment

5. Expected revenues mid-term growth (12.09%)

6. Segments

Finished Pharmaceutical Products

Expected Growth: 12%

Amphastar Pharmaceuticals' Finished Pharmaceutical Products segment growth is driven by increasing demand for generic injectables, expansion into new markets, and a strong product pipeline. Additionally, the company's focus on quality and reliability, as well as its ability to capitalize on industry trends such as outsourcing and consolidation, contribute to its 12% growth.

Active Pharmaceutical Ingredients

Expected Growth: 16%

Amphastar Pharmaceuticals' 16% growth in Active Pharmaceutical Ingredients is driven by increasing demand for generic injectables, strategic partnerships, and expansion into new markets. Additionally, the company's focus on R&D and regulatory approvals for new products has contributed to the growth. Furthermore, the rising need for affordable healthcare solutions and the growing importance of pharmaceutical outsourcing also support the segment's growth.

7. Detailed Products

Primatene MIST

An over-the-counter (OTC) inhaler used to treat mild, intermittent asthma

Methyldopate HCL

An injectable medication used to treat hypertension

Phytonadione

A vitamin K1 injection used to treat bleeding disorders

Sodium Thiosulfate

An injectable medication used to treat cyanide poisoning

Naloxone HCL

An injectable medication used to treat opioid overdose

8. Amphastar Pharmaceuticals, Inc.'s Porter Forces

Forces Ranking

Threat Of Substitutes

The threat of substitutes for Amphastar Pharmaceuticals, Inc. is medium due to the presence of alternative pharmaceutical products in the market.

Bargaining Power Of Customers

The bargaining power of customers for Amphastar Pharmaceuticals, Inc. is low due to the company's strong brand presence and limited switching options for customers.

Bargaining Power Of Suppliers

The bargaining power of suppliers for Amphastar Pharmaceuticals, Inc. is medium due to the presence of multiple suppliers in the market, but the company's large scale of operations gives it some negotiating power.

Threat Of New Entrants

The threat of new entrants for Amphastar Pharmaceuticals, Inc. is high due to the relatively low barriers to entry in the pharmaceutical industry and the presence of venture capital funding for new startups.

Intensity Of Rivalry

The intensity of rivalry for Amphastar Pharmaceuticals, Inc. is high due to the presence of multiple established players in the market, leading to intense competition for market share.

9. SWOT Analysis

Strength

Weaknesses

Opportunities

Threats

10. Capital Structure

10.a. Balance Sheet

10.b. Weighted Average Cost of capital

Value
Debt Weight 48.14%
Debt Cost 5.74%
Equity Weight 51.86%
Equity Cost 8.21%
WACC 7.02%
Leverage 92.82%

11. Quality Control: Amphastar Pharmaceuticals, Inc. passed 5 out of 9 key points

12.a Historical Valuation

12.b Price/Earnings Ratio

12.c Margin Valuation

12.d Peers Valuation

Peers Group Analysis

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Peers Metrics

12.e Scoring Insights

12.f DCF BETA

Parameters

Short Term Growth

Short term Time

Long-Term Growth

WACC

Target Price

26.77$

Current Price

26.77$

Potential

-0.00%

Expected Cash-Flows