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Compared to Estimates, Amphastar (AMPH) Q4 Earnings: A Look at Key Metrics
ZACKS· 2026-02-27 02:30
Core Insights - Amphastar Pharmaceuticals reported a revenue of $183.11 million for the quarter ended December 2025, reflecting a year-over-year decline of 1.8% and an EPS of $0.73, down from $0.92 a year ago [1] - The revenue fell short of the Zacks Consensus Estimate of $194.03 million by 5.63%, while the EPS was 24.49% below the consensus estimate of $0.97 [1] Revenue Performance - BAQSIMI generated net revenues of $46.71 million, which is 11.8% higher year-over-year but below the average estimate of $52.07 million from two analysts [4] - Primatene MIST reported net revenues of $27.93 million, a decrease of 3.5% compared to the previous year and below the estimated $31.48 million [4] - Lidocaine achieved net revenues of $14.9 million, exceeding the estimate of $13.51 million and showing a year-over-year increase of 3.5% [4] - Epinephrine's net revenues were $17.09 million, down 8.6% year-over-year and below the average estimate of $19.78 million [4] - Glucagon reported net revenues of $14.08 million, significantly higher than the estimated $10.59 million, but this represents a drastic year-over-year decline of 45% [4] Stock Performance - Amphastar's shares have returned +7.1% over the past month, outperforming the Zacks S&P 500 composite, which saw a change of +0.6% [3] - The stock currently holds a Zacks Rank 4 (Sell), indicating potential underperformance relative to the broader market in the near term [3]
Amphastar Pharmaceuticals(AMPH) - 2025 Q4 - Earnings Call Transcript
2026-02-26 23:02
Financial Data and Key Metrics Changes - For the full year 2025, net revenues were $719.9 million, with a modest decline of 2% year-over-year due to headwinds in legacy products [6][7] - Fourth quarter sales decreased 2% to $183.1 million from $186.5 million in the previous year, with net income reported at $24.4 million, or $0.51 per share, down from $38 million, or $0.74 per share in the prior year [11][14] - Adjusted net income for the fourth quarter was $34.2 million, or $0.73 per share, compared to $47.2 million, or $0.92 per share in the previous year [15] Business Line Data and Key Metrics Changes - BAQSIMI generated $185.4 million in revenue for the full year, up 12% year-over-year, while Primatene MIST sales rose 7% to $108.7 million [6][7] - In the fourth quarter, BAQSIMI sales grew 12% to $46.7 million, while Primatene MIST sales dropped 3% to $27.9 million [11][12] - Glucagon sales declined 45% to $14.1 million due to increased competition, and epinephrine sales decreased 9% to $17.1 million [12] Market Data and Key Metrics Changes - The company expects mid-single-digit unit growth for BAQSIMI in the U.S., offset by a planned reduction in international volume as it exits unprofitable markets [16][29] - The Atrovent market, associated with Ipratropium Bromide, was valued at $112 million last year, with expectations of meaningful market share due to 180 days of exclusivity [32] Company Strategy and Development Direction - The company aims to transition towards a portfolio anchored in high-value proprietary and biosimilar assets, with significant investments in R&D and manufacturing capabilities [5][9] - The expansion of the U.S. manufacturing facility in Rancho Cucamonga is a critical part of the long-term strategy, expected to quadruple production capacity [9][18] - The company plans to ramp up spending on clinical trials and materials for inhalation and proprietary pipeline products, with a focus on oncology, ophthalmology, and immunology [18][25] Management's Comments on Operating Environment and Future Outlook - Management highlighted the importance of resilient commercial momentum and strategic pipeline progress, with expectations for consolidated revenue growth in the mid-to-high single-digit range for 2026 [20][17] - Gross margins are expected to be lower in 2026 due to pricing pressures on glucagon and epinephrine, alongside increased input costs [17][39] Other Important Information - The company has over $300 million in cash and short-term investments, with plans to utilize a portion for stock buybacks while also exploring business development opportunities [18][40] - The company achieved several major regulatory milestones in 2025, including FDA approvals for iron sucrose, teriparatide, and Ipratropium Bromide HFA [20][8] Q&A Session Summary Question: Development path for AMP-110 and business development priorities - Management has not yet engaged the FDA regarding AMP-110 but is preparing the program [24] - Business development will focus on areas where the company has or plans to have a presence, including endocrinology and oncology [25] Question: BAQSIMI expectations for 2026 and international sales - BAQSIMI is expected to see mid-single-digit growth in the U.S., with international sales declining in the second half of the year [29][30] Question: Gross margins and buyback plans - BAQSIMI growth will help margins, but declines in glucagon and epinephrine will offset this [39] - The company plans to continue buybacks, with $75 million as a potential high end for the year [40] Question: Competition for Primatene MIST and filing cadence - The patent for Primatene MIST has expired, but management does not anticipate significant competition [45] - The company expects to have 2 filings late this year and 2-3 filings next year [47] Question: Updates on Nanjing Anji in-licensed assets - The company is in the preclinical stage for these assets and is optimistic about their potential [50][51]
Amphastar Pharmaceuticals(AMPH) - 2025 Q4 - Earnings Call Transcript
2026-02-26 23:02
Amphastar Pharmaceuticals (NasdaqGS:AMPH) Q4 2025 Earnings call February 26, 2026 05:00 PM ET Company ParticipantsBill Peters - CFODan Dischner - SVP of Corporate CommunicationsPavan Patel - Associate of Biotech & Pharma Equity ResearchSerge Belanger - Managing Director of BioPharma Equity ResearchTony Marrs - EVP of Regulatory Affairs and Clinical OperationsConference Call ParticipantsDavid Amsellem - Managing Director and Senior Research AnalystEkaterina Knyazkova - Equity Research AnalystTianxi Cai - Ana ...
Amphastar Pharmaceuticals(AMPH) - 2025 Q4 - Earnings Call Transcript
2026-02-26 23:00
Amphastar Pharmaceuticals (NasdaqGS:AMPH) Q4 2025 Earnings call February 26, 2026 05:00 PM ET Speaker4Greetings, and welcome to the Amphastar Pharmaceuticals fourth quarter earnings call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note that certain statements made during this call regarding matters that a ...
Amphastar Pharmaceuticals(AMPH) - 2025 Q4 - Earnings Call Presentation
2026-02-26 22:00
Corporate Presentation February 2026 Highly Purified Peptide/Protein Biosimilar Interchangeable Proprietary Injectables Inhalation Intranasal New Molecular Peptides Oncology Ophthalmology Rheumatology 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. ...
Amphastar Pharmaceuticals(AMPH) - 2025 Q4 - Annual Report
2026-02-26 21:41
Financial Position - The company has $111.4 million in cash equivalents, including money market accounts, as of December 31, 2025[582]. - The company had $96.1 million in investment grade corporate and municipal bonds as of December 31, 2025[582]. - The company experienced a decline in cash equivalents from $102.1 million in 2024 to $111.4 million in 2025, indicating a growth in liquidity[582][583]. - The company maintains significant cash balances exceeding federally insured limits, which poses a normal business risk[584]. - As of December 31, 2025, the company had $610.4 million in long-term debt and finance leases, all with fixed interest rates or locked-in fixed rates through swap contracts[586]. Tax and Regulatory Risks - The company is subject to changes in tax laws, such as the 1% excise tax on stock repurchases and a 15% alternative minimum tax on adjusted financial statement income[468]. - The company is evaluating the impact of the OBBB Act on its financial position and results of operations[468]. - The company is subject to significant judgment in determining its worldwide provision for income taxes, which may lead to material differences in tax audits[469]. Market Risks - The company is exposed to market risks including investment risk, interest rate risk, and foreign currency exchange risk[580]. - The company is primarily exposed to interest rate risk through interest rate sensitive investments and credit facilities, but believes it is not subject to material risk with respect to short-term investments[585]. - The company's operations in France are exposed to market risk related to changes in foreign currency exchange rates due to sales contracts frequently denominated in euros[587]. Foreign Currency Exposure - A theoretical 10% unfavorable change in the exchange rate of the U.S. dollar against foreign currencies would result in approximately $0.1 million reduction of foreign currency gains and approximately $3.6 million reduction in other comprehensive income as of December 31, 2025[591]. - As of December 31, 2024, a theoretical 10% unfavorable change in the exchange rate would lead to approximately $1.2 million reduction of foreign currency gains and approximately $3.1 million reduction in other comprehensive income[592]. - The company's foreign subsidiaries had cash balances in foreign currencies amounting to $7.7 million and $6.6 million as of December 31, 2025 and 2024, respectively[592]. - The company may enter into derivative contracts to manage interest-rate exposures and achieve a balance between fixed- and floating-rate debt[585]. - The unrealized gains or losses from intercompany foreign currency transactions of a long-term investment nature are reported in other accumulated comprehensive income (loss)[589]. - The company's Chinese subsidiary maintains its books in Chinese yuan, which are remeasured into USD using current or historical exchange rates[588]. - The company is exposed to potential earnings effects from intercompany foreign currency assets and liabilities arising from normal trade receivables and payables[590]. Operational Risks - The company’s operating results may fluctuate significantly due to various factors, including the commercial success of key products and regulatory actions[475]. - The company recorded no declines in fair value of investments that are considered other than temporary as of December 31, 2025[581].
Amphastar Pharmaceuticals(AMPH) - 2025 Q4 - Annual Results
2026-02-26 21:24
EXHIBIT 99.1 Amphastar Pharmaceuticals Reports Financial Results for the Three Months and Full Year Ended December 31, 2025 RANCHO CUCAMONGA, CA – February 26, 2026 – Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) ("Amphastar" or the "Company"), a biopharmaceutical company focused on developing, manufacturing, and commercializing technically challenging generic and proprietary injectable, inhalation, and intranasal products, today reported results for the three months and full year ended December 31, 2025. ...
Amphastar Pharmaceuticals Reports Financial Results for the Three Months and Full Year Ended December 31, 2025
Accessnewswire· 2026-02-26 21:05
Net revenues of $183.1 million and $719.9 million, respectively, for the three months and fiscal year ended December 31, 2025 GAAP net income of $24.4 million, or $0.51 per share and $98.1 million, or $2.03 per share, respectively, for the fourth quarter and fiscal year Adjusted non-GAAP net income of $34.2 million, or $0.73 per share and $156.6 million, or $3.25 per share, respectively, for the fourth quarter and fiscal year Company to hold a conference call today at 2:00 p.m. Pacific Time RANCHO CUCAMONGA ...
Amphastar Announces FDA Approval for Ipratropium Bromide HFA
Accessnewswire· 2026-02-24 11:00
Amphastar Announces FDA Approval for Ipratropium Bromide HFA ELEMENT--[Back to the Newsroom]# Amphastar Announces FDA Approval for Ipratropium Bromide HFARANCHO CUCAMONGA, CA / [ACCESS Newswire]/ February 24, 2026 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced that the U.S. Food and Drug Administration ("FDA") has approved the Company's Abbreviated New Drug Application ("ANDA") for Ipratropium Bromide HFA Inhalation Aerosol 17mcg/actuation. The FDA determined that Amphastar's Ipratropium Bromide ...
Amphastar Pharmaceuticals to Release Fourth Quarter Earnings and Hold Conference Call on February 26, 2026
Accessnewswire· 2026-02-20 11:00
Core Viewpoint - Amphastar Pharmaceuticals, Inc. will announce its fourth quarter results for 2025 on February 26, 2026, after market close [1] Financial Results Announcement - The financial results will cover the period ended December 31, 2025 [1] - A conference call to discuss these results is scheduled for 2:00 p.m. Pacific Time on the same day [1]