Amphastar Pharmaceuticals(AMPH)

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Amphastar Secures FDA Nod For Iron Sucrose Injection, Analysts Eye Major Sales Momentum
Benzinga· 2025-08-12 17:38
On Monday, the U.S. Food and Drug Administration (FDA) approved Amphastar Pharmaceuticals, Inc.’s AMPH Abbreviated New Drug Application (ANDA) for Iron Sucrose Injection, USP 50mg/2.5mL, 100mg/5mL, and 200mg/10mL in single-dose vials, previously referred to as AMP-002.Iron sucrose injection is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).“We look forward to launching our iron sucrose injection in the third quarter of 20 ...
Amphastar (AMPH) Reports Q2 Earnings: What Key Metrics Have to Say
ZACKS· 2025-08-07 22:31
For the quarter ended June 2025, Amphastar Pharmaceuticals (AMPH) reported revenue of $174.41 million, down 4.4% over the same period last year. EPS came in at $0.85, compared to $0.94 in the year-ago quarter.The reported revenue compares to the Zacks Consensus Estimate of $169.84 million, representing a surprise of +2.69%. The company delivered an EPS surprise of +19.72%, with the consensus EPS estimate being $0.71.While investors closely watch year-over-year changes in headline numbers -- revenue and earn ...
Amphastar Pharmaceuticals (AMPH) Q2 Earnings and Revenues Beat Estimates
ZACKS· 2025-08-07 22:15
Amphastar Pharmaceuticals (AMPH) came out with quarterly earnings of $0.85 per share, beating the Zacks Consensus Estimate of $0.71 per share. This compares to earnings of $0.94 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of +19.72%. A quarter ago, it was expected that this specialty pharmaceutical company would post earnings of $0.66 per share when it actually produced earnings of $0.74, delivering a surprise of +12.12%.Over ...
Amphastar Pharmaceuticals(AMPH) - 2025 Q2 - Earnings Call Transcript
2025-08-07 22:00
Amphastar Pharmaceuticals (AMPH) Q2 2025 Earnings Call August 07, 2025 05:00 PM ET Speaker0Please note that certain statements made during this call regarding matters that are not historical facts, including, but not limited to management's outlook or predictions for future periods, are forward looking statements. These statements are based solely on information that is now available to us.We encourage you to review the session entitled Forward Looking Statements in the press release issued today and the pr ...
Amphastar Pharmaceuticals(AMPH) - 2025 Q2 - Earnings Call Presentation
2025-08-07 21:00
Corporate Presentation August 2025 Highly Purified Peptide/Protein Proprietary Injectables Inhalation Intranasal Biosimilar Interchangeable Complex Generic Combination Products Forward Looking Statements This presentation and the accompanying oral presentation contain forward-looking statements, of Amphastar Pharmaceuticals, Inc. ("Amphastar", "we". "our" and that are based on our management's current expectations and assumptions and on information currently available to management. Forward-looking statemen ...
Amphastar Pharmaceuticals(AMPH) - 2025 Q2 - Quarterly Report
2025-08-07 20:43
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ◻ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-36509 AMPHASTAR PHARMACEUTICALS, INC. (Exact name of Registrant as specified in its charter) Delaware 33-0702205 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 11570 6 th Street Rancho Cucamonga, CA 91730 (Address of ...
Amphastar Pharmaceuticals(AMPH) - 2025 Q2 - Quarterly Results
2025-08-07 20:31
EXHIBIT 99.1 Amphastar Pharmaceuticals Reports Financial Results for the Three Months Ended June 30, 2025 RANCHO CUCAMONGA, CA – August 7, 2025 – Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) ("Amphastar" or the "Company"), a biopharmaceutical company focused on developing, manufacturing, and marketing complex generic and proprietary injectable, inhalation, and intranasal products, today reported results for the three months ended June 30, 2025. "We are pleased to report strong second-quarter performance, ...
What Makes Amphastar (AMPH) a New Buy Stock
ZACKS· 2025-07-23 17:00
Core Viewpoint - Amphastar Pharmaceuticals (AMPH) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system emphasizes the importance of changing earnings estimates, which are closely correlated with stock price movements, particularly due to institutional investors' reliance on these estimates for valuation [4][6]. - For Amphastar, the recent upgrade reflects an improvement in the company's underlying business, suggesting that investor sentiment may drive the stock price higher [5][10]. Earnings Estimate Revisions - For the fiscal year ending December 2025, Amphastar is expected to earn $3.17 per share, which remains unchanged from the previous year, but the Zacks Consensus Estimate has increased by 0.5% over the past three months [8]. Zacks Rank System - The Zacks Rank system categorizes stocks based on earnings estimate revisions, with only the top 20% of stocks receiving a "Strong Buy" or "Buy" rating, indicating superior potential for market-beating returns [9][10].
Here's Why Amphastar (AMPH) is Poised for a Turnaround After Losing 13.1% in 4 Weeks
ZACKS· 2025-07-23 14:36
Core Viewpoint - Amphastar Pharmaceuticals (AMPH) has experienced a significant downtrend, with a 13.1% decline in stock price over the past four weeks, but it is now in oversold territory, suggesting a potential turnaround due to improved earnings expectations from analysts [1]. Group 1: Technical Analysis - The Relative Strength Index (RSI) is a key technical indicator used to determine if a stock is oversold, with readings below 30 indicating oversold conditions [2]. - AMPH's current RSI reading is 29.97, suggesting that the heavy selling pressure may be exhausting, indicating a possible bounce back towards equilibrium in supply and demand [5]. Group 2: Fundamental Analysis - Analysts have shown strong consensus in raising earnings estimates for AMPH, with a 3.4% increase in the consensus EPS estimate over the last 30 days, which typically correlates with price appreciation [7]. - AMPH holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further supporting the potential for a near-term turnaround [8].
Amphastar Pharmaceuticals (AMPH) 2025 Conference Transcript
2025-06-05 19:02
Amphastar Pharmaceuticals Conference Call Summary Company Overview - Amphastar Pharmaceuticals is a biopharmaceutical company focused on injectable and inhalation products, emphasizing complex generic injectables and proprietary products [4][5] - Key products include Primatene Mist, the only OTC FDA-approved asthma medication, and Baqsimi, a nasal glucagon product acquired from Eli Lilly [5] Financial Performance - The company anticipates flat revenues for the year, with slight declines in earnings due to increased competition affecting gross margins on key products [7] - A significant increase in R&D budget is noted as the company explores more complex generic products and proprietary offerings [7] - The goal is to return to double-digit sales growth in the following year [8] Product Insights Baqsimi - Baqsimi is a major growth driver, with growth attributed to increased awareness and feasibility among insulin-prescribing patients [9] - Currently, only about 12% of insulin patients have glucagon on hand, indicating significant room for growth [10][11] - The product's ease of use compared to traditional glucagon kits is highlighted as a competitive advantage [15][19] - Baqsimi is expected to see high single-digit growth for the year, with a price increase of 3% in the U.S. contributing to overall sales growth [22][28] Primatene Mist - Primatene Mist is projected to grow by high single digits this year, supported by national media coverage and expanded marketing efforts targeting primary care physicians [30][31] - The company is piloting a small sales force to enhance brand growth, with plans to evaluate its success in 2026 [32][35] Competitive Landscape - Baqsimi is the leading prescribed glucagon in the U.S., outperforming competitors like Gvoke due to its intranasal delivery method, which is preferred by caregivers [18][20] - The company is optimistic about maintaining its market position and continuing to grow its share [16][19] Pipeline and Future Growth - Amphastar has four ANDAs under FDA review, with expectations to receive approvals for two products by year-end [39] - The pipeline includes complex generics and an inhalation product, which is seen as promising due to the lack of existing generics in the market [53][56] - The company anticipates peak sales for Baqsimi in the range of $250 million to $275 million over the next several years [26] Manufacturing and Tariff Exposure - All finished products are manufactured in the U.S., with some active ingredients sourced from China and France [63] - The company estimates a quarterly impact of approximately $500,000 due to tariffs on certain APIs, but this is not considered material [64] R&D Strategy - Amphastar's strategy focuses on internal R&D, leveraging the expertise of its scientific founders [69] - The company is open to future acquisitions that align with its manufacturing capabilities and product focus, particularly in the endocrinology space [70]