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Amphastar Pharmaceuticals Inc (AMPH)
:AMPH
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Amphastar Pharmaceuticals (AMPH) AI Stock Analysis

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AMPH

Amphastar Pharmaceuticals

(NASDAQ:AMPH)

Rating:68Neutral
Price Target:
$32.00
▲(5.47% Upside)
Amphastar Pharmaceuticals' overall stock score is driven by its strong financial performance and undervaluation, despite recent revenue and cash flow challenges. Technical indicators suggest caution due to overbought conditions, while strategic initiatives in R&D and manufacturing expansion provide a positive outlook.
Positive Factors
FDA Approval
AMP-002 is an iron sucrose injection product that received FDA approval as an equivalent to Venofer, a ~$515MM product based on last 12mths of IQVIA sales.
Market Opportunity
AMP-002 will compete in the 2/3's of the Venofer market or the dialysis setting that isn't controlled by Fresenius and could generate sales of $80MM-$100MM for AMPH.
Valuation
AMPH is considered to be at an attractive valuation for potential entry.
Negative Factors
Competition
The only downside to the approval news, which comes with a 6-month exclusivity period, is an equivalent generic product by Viatris was also approved.
Pipeline Setbacks
The company has seen continued setbacks on the pipeline front, including the two most recent CRLs on AMP-007 and AMP-018, which along with AMP-002 were key to offsetting erosion for the generic portfolio.
Revenue Decline
AMPH is facing several headwinds in 2025/2026, which should also pressure margins, with expected significant revenue decline in Glucagon and cautious outlook on epinephrine.

Amphastar Pharmaceuticals (AMPH) vs. SPDR S&P 500 ETF (SPY)

Amphastar Pharmaceuticals Business Overview & Revenue Model

Company DescriptionAmphastar 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.
How the Company Makes MoneyAmphastar Pharmaceuticals generates revenue primarily through the sale of its pharmaceutical products, which are categorized into generic and proprietary offerings. The company has established key revenue streams from its injectable products, including the sale of generic versions of high-demand medications. Additionally, Amphastar benefits from partnerships with healthcare organizations and distributors that enhance its market reach and product availability. The company's revenue model is supported by pricing strategies that take into account market demand and competition, as well as potential cost savings associated with its manufacturing processes. Moreover, the company is involved in the development of new products, which can lead to increased revenue through patent protections and exclusivity periods. Significant partnerships with other pharmaceutical firms also play a role in expanding Amphastar's product portfolio and distribution channels, contributing to its overall earnings.

Amphastar Pharmaceuticals Earnings Call Summary

Earnings Call Date:Aug 07, 2025
(Q2-2025)
|
% Change Since: 40.33%|
Next Earnings Date:Nov 10, 2025
Earnings Call Sentiment Neutral
The call highlighted strong performance in certain products like BAQSIMI and strategic expansions in manufacturing. However, there were significant challenges including a decline in overall revenue, competition affecting multiple product lines, and pressure on margins, leading to a lower net income.
Q2-2025 Updates
Positive Updates
Strong BAQSIMI Performance
BAQSIMI sales grew to $46.7 million, up 21% year-over-year, driven by successful global commercialization and increased unit volume and higher average selling prices.
California Headquarters Expansion
Announced a significant expansion aimed at quadrupling manufacturing capacity, enhancing operational resilience and R&D pipeline advancement.
R&D and Regulatory Progress
R&D expense rose 14% year-over-year. Optimism for near-term approval of AMP-002 and progress in other regulatory programs, like AMP-007 and AMP-015, is on track.
Continued Success of Primatene MIST
Stable performance with sales holding steady at $22.9 million, reflecting consistent consumer demand.
Negative Updates
Overall Revenue Decline
Second quarter revenues decreased by 4% to $174.4 million due to increased competition in legacy products.
Glucagon Injection Sales Drop
Sales declined 25% to $20.6 million due to increased competition and a shift to ready-to-use products.
Epinephrine Sales Decline
Sales decreased 42% to $16.2 million due to increased competition and market share erosion.
Margin Pressure
Gross margins declined to 49.6% from 52.2% due to pricing declines from competition.
Net Income Decrease
Net income decreased to $31 million from $37.9 million in the previous year.
Company Guidance
During Amphastar Pharmaceuticals' second-quarter 2025 earnings call, the company reported net revenues of $174.4 million, a 4% decrease from the previous year's period, and a GAAP net income of $31 million or $0.64 per diluted share. The non-GAAP adjusted net income was $40.9 million or $0.85 per diluted share. BAQSIMI emerged as a significant contributor, with sales growing 21% year-over-year to $46.7 million due to increased unit volume and pricing. Primatene MIST maintained stable performance with $22.9 million in sales. However, glucagon injection and epinephrine sales fell 25% and 42%, respectively, due to increased competition. The company is expanding its California headquarters to quadruple domestic manufacturing capacity, enhancing operational resilience amid geopolitical challenges. Amphastar is optimistic about near-term FDA approval for its AMP-002 product and anticipates a GDUFA date for AMP-007 in the first half of 2026. The company is strategically focused on sustainable growth through pipeline advancement and increased R&D investment, with a 14% rise in R&D expenses year-over-year.

Amphastar Pharmaceuticals Financial Statement Overview

Summary
Amphastar Pharmaceuticals shows strong financial health with consistent revenue growth and solid profitability margins. While there is a slight decline in net profit margin, the company's operational efficiency and effective cash flow management provide a strong foundation. The balanced leverage and robust ROE further underline its financial stability. Overall, Amphastar is well-positioned for sustainable growth, with some areas for improvement in margin expansion and liability management.
Income Statement
85
Very Positive
Amphastar Pharmaceuticals demonstrates strong financial performance with consistent revenue growth, evidenced by a TTM revenue of $728.26M, a 3.24% growth from the previous year. The gross profit margin remains solid at 50.24%, indicating effective cost management. However, the net profit margin has slightly decreased to 19.45% in the TTM period from 22.37% in 2024, suggesting some pressure on profitability. The EBIT margin is stable at 26.74%, while the EBITDA margin is healthy at 33.03%, reflecting strong operational efficiency.
Balance Sheet
78
Positive
The company's balance sheet shows a moderate debt-to-equity ratio of 0.87, indicating a balanced approach to leveraging. Return on Equity (ROE) is robust at 18.85%, showcasing effective use of equity capital. The equity ratio stands at 46.19%, suggesting a solid capital structure with room for improvement in reducing liabilities further.
Cash Flow
82
Very Positive
Amphastar has demonstrated strong cash flow generation with a free cash flow growth of -12.84% in the latest TTM period, which is a decline but still positive in absolute terms at $150.23M. The operating cash flow to net income ratio is impressive at 1.36, indicating good cash generation from operations. The free cash flow to net income ratio is 1.06, reflecting efficient capital expenditure management.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue720.28M712.81M644.39M498.99M437.77M349.85M
Gross Profit360.33M373.86M351.12M248.86M199.74M143.34M
EBITDA248.07M277.31M240.29M146.16M111.78M30.19M
Net Income134.71M159.52M137.54M91.39M62.12M1.40M
Balance Sheet
Total Assets1.62B1.58B1.51B741.99M671.53M631.24M
Cash, Cash Equivalents and Short-Term Investments231.75M221.65M256.81M175.76M136.67M105.62M
Total Debt47.77M650.55M623.64M102.58M104.66M67.27M
Total Liabilities857.85M845.17M873.49M213.33M226.01M182.51M
Stockholders Equity757.48M732.30M639.42M528.66M445.52M402.31M
Cash Flow
Free Cash Flow112.19M172.34M145.34M65.15M70.54M23.41M
Operating Cash Flow159.66M213.39M183.50M89.18M97.99M57.27M
Investing Cash Flow-60.41M-124.93M-649.12M-32.78M-28.67M-36.41M
Financing Cash Flow-101.36M-80.95M454.09M-26.44M-37.02M-2.25M

Amphastar Pharmaceuticals Technical Analysis

Technical Analysis Sentiment
Neutral
Last Price30.34
Price Trends
50DMA
24.25
Positive
100DMA
24.53
Positive
200DMA
30.49
Negative
Market Momentum
MACD
2.07
Negative
RSI
68.91
Neutral
STOCH
58.34
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For AMPH, the sentiment is Neutral. The current price of 30.34 is above the 20-day moving average (MA) of 26.11, above the 50-day MA of 24.25, and below the 200-day MA of 30.49, indicating a neutral trend. The MACD of 2.07 indicates Negative momentum. The RSI at 68.91 is Neutral, neither overbought nor oversold. The STOCH value of 58.34 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral sentiment for AMPH.

Amphastar Pharmaceuticals Risk Analysis

Amphastar Pharmaceuticals disclosed 85 risk factors in its most recent earnings report. Amphastar Pharmaceuticals reported the most risks in the "Legal & Regulatory" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Amphastar Pharmaceuticals Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
76
Outperform
$2.49B38.836.38%5.55%1145.24%
73
Outperform
$1.22B37.4316.16%22.61%-63.00%
68
Neutral
$1.41B11.3618.32%1.37%-18.10%
66
Neutral
$1.44B-3.63%132.35%97.34%
66
Neutral
$1.96B-2.82%38.68%-160.14%
61
Neutral
$1.14B-15.57%2.25%-301.59%
51
Neutral
$7.83B-0.15-40.10%2.29%21.46%-2.01%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
AMPH
Amphastar Pharmaceuticals
30.34
-18.22
-37.52%
AVDL
Avadel Pharmaceuticals
14.85
>-0.01
-0.07%
PCRX
Pacira Pharmaceuticals
25.99
11.09
74.43%
SUPN
Supernus Pharmaceuticals
44.32
9.68
27.94%
ANIP
ANI Pharmaceuticals
91.89
29.17
46.51%
COLL
Collegium Pharmaceutical
38.58
1.49
4.02%

Amphastar Pharmaceuticals Corporate Events

Business Operations and Strategy
Amphastar Pharmaceuticals Enters Strategic Licensing Agreement
Positive
Aug 12, 2025

On August 8, 2025, Amphastar Pharmaceuticals entered into a strategic licensing agreement with Nanjing Anji Biotechnology Co., Ltd. to develop and commercialize three proprietary peptides in the United States and Canada. This collaboration aims to enhance Amphastar’s pipeline in oncology and ophthalmology, with potential milestone payments to Anji reaching up to $453 million over the agreement’s term. The partnership underscores Amphastar’s commitment to advancing peptide therapeutics and expanding its market presence in high-growth areas.

Executive/Board ChangesShareholder MeetingsBusiness Operations and Strategy
Amphastar Pharmaceuticals Stockholders Approve Key Amendments
Neutral
Jun 4, 2025

At the 2025 Annual Meeting of Stockholders held on June 2, 2025, Amphastar Pharmaceuticals‘ stockholders approved several key amendments to the company’s Charter and Bylaws. These included changes to reflect Delaware law provisions regarding officer exculpation and the removal of the forum selection provision. Additionally, the election of three Class III directors, the ratification of Ernst & Young LLP as the independent accounting firm, and the approval of executive compensation were confirmed. These decisions are expected to impact the company’s governance structure and operational flexibility, potentially influencing its strategic direction and stakeholder relations.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Aug 19, 2025