Back to Rankings

AMPH

AmphastarD
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
Last Price
At close
2026-06-02
View Chart
Documents
70
Stored
Transcripts
1
Recent loaded
Latest report
2026-05-17
Investor release

Document history

Earnings documents stored for AMPH.

12 shown
Investor releaseQuarter not tagged2026-05-17

The 5 Most Interesting Analyst Questions From Amphastar Pharmaceuticals’s Q1 Earnings Call

StockStory

Amphastar Pharmaceuticals’ first quarter was marked by flat revenue and a significant shortfall in non-GAAP profit compared to analyst expectations, prompting a negative market reaction. Management cited continued pricing pressure, especially in its branded diabetes product BAQSIMI, and increased competition in selected product categories as key drivers behind the results. CFO William Peters acknowledged, “The pricing issue that we've been encountering appears to be potentially the increase of -- there's multiple things going on there. One, there's some increased rebates, but also potentially, we believe some duplicate rebates, which seems to be a 340B pharmacy issue.” Is now the time to buy AMPH? Find out in our full research report (it’s free). Revenue: $171.2 million vs analyst estimates of $173.1 million (flat year on year, 1.1% miss) Adjusted EPS: $0.42 vs analyst expectations of $0.71 (40.5% miss) Adjusted EBITDA: $60.21 million vs analyst estimates of $77.47 million (35.2% margin, 22.3% miss) Operating Margin: 8%, down from 21.9% in the same quarter last year Market Capitalization: $807.8 million While we enjoy listening to the management's commentary, our favorite part of earnings calls are the analyst questions. Those are unscripted and can often highlight topics that management teams would rather avoid or topics where the answer is complicated. Here is what has caught our attention. Serge Belanger (Needham & Company) asked about the duration and nature of BAQSIMI pricing pressures and the impact of exiting certain international markets. CFO William Peters explained that pricing issues stem from increased and potentially duplicate rebates, and that international exits will be gradual, with limited top-line impact. Anthea Li (Jefferies) inquired about timelines and regulatory status for the synthetic corticotropin and insulin aspart biosimilar programs. EVP Tony Marrs confirmed that regulatory meetings have not yet occurred for corticotropin and reaffirmed a 2027 launch target for insulin aspart. Ekaterina Knyazkova (JPMorgan) questioned the commercial potential and ramp for the insulin aspart biosimilar as well as future trends in glucagon sales. Peters indicated that the product represents a significant market opportunity but will require time to ramp depending on interchangeability status, while glucagon sales are expected to decline further but a...

Investor releaseQuarter not tagged2026-05-16

Q1 Earnings Roundup: Amphastar Pharmaceuticals (NASDAQ:AMPH) And The Rest Of The Pharmaceuticals Segment

StockStory

As the craze of earnings season draws to a close, here’s a look back at some of the most exciting (and some less so) results from Q1. Today, we are looking at pharmaceuticals stocks, starting with Amphastar Pharmaceuticals (NASDAQ:AMPH). The pharmaceuticals sector develops, manufactures, and distributes drugs, benefiting from diversified portfolios of branded and generic medications. Looking ahead, growth will be driven by innovations in precision medicine, such as genetic therapies and advanced biologics, and the increasing use of AI to speed and increase the efficiency of drug discovery. These could specifically magnify the advantages of the most scaled players. Conversely, the sector faces considerable headwinds from intense, bipartisan political pressure on drug pricing, scrutiny of patent practices, and growing competition from biosimilars. These could specifically stymie the growth of smaller companies or ones facing patent expirations on key drugs. The 17 pharmaceuticals stocks we track reported a mixed Q1. As a group, revenues beat analysts’ consensus estimates by 1.5% while next quarter’s revenue guidance was in line. While some pharmaceuticals stocks have fared somewhat better than others, they have collectively declined. On average, share prices are down 4.1% since the latest earnings results. Founded in 1996 and known for its expertise in complex drug formulations, Amphastar Pharmaceuticals (NASDAQ:AMPH) develops and manufactures technically challenging injectable and inhalation medications, including both generic and proprietary pharmaceutical products. Amphastar Pharmaceuticals reported revenues of $171.2 million, flat year on year. This print fell short of analysts’ expectations by 1.1%. Overall, it was a disappointing quarter for the company with a significant miss of analysts’ EPS and revenue estimates. Unsurprisingly, the stock is down 25.1% since reporting and currently trades at $18.00. Read our full report on Amphastar Pharmaceuticals here, it’s free. Founded in 1876 by a Civil War veteran and pharmacist frustrated with the poor quality of medicines, Eli Lilly (NYSE:LLY) discovers, develops, and manufactures pharmaceutical products for conditions including diabetes, obesity, cancer, immunological disorders, and neurological diseases. Eli Lilly reported revenues of $19.8 billion, up 55.5% year on year, outperforming analysts’ expectations...

Investor releaseQuarter not tagged2026-05-15

Amphastar Pharmaceuticals' (NASDAQ:AMPH) Conservative Accounting Might Explain Soft Earnings

Simply Wall St.

Amphastar Pharmaceuticals, Inc.'s (NASDAQ:AMPH) earnings announcement last week didn't impress shareholders. However, our analysis suggests that the soft headline numbers are getting counterbalanced by some positive underlying factors. AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. Importantly, our data indicates that Amphastar Pharmaceuticals' profit was reduced by US$23m, due to unusual items, over the last year. It's never great to see unusual items costing the company profits, but on the upside, things might improve sooner rather than later. When we analysed the vast majority of listed companies worldwide, we found that significant unusual items are often not repeated. And that's hardly a surprise given these line items are considered unusual. If Amphastar Pharmaceuticals doesn't see those unusual expenses repeat, then all else being equal we'd expect its profit to increase over the coming year. That might leave you wondering what analysts are forecasting in terms of future profitability. Luckily, you can click here to see an interactive graph depicting future profitability, based on their estimates. Because unusual items detracted from Amphastar Pharmaceuticals' earnings over the last year, you could argue that we can expect an improved result in the current quarter. Because of this, we think Amphastar Pharmaceuticals' earnings potential is at least as good as it seems, and maybe even better! On the other hand, its EPS actually shrunk in the last twelve months. The goal of this article has been to assess how well we can rely on the statutory earnings to reflect the company's potential, but there is plenty more to consider. If you want to do dive deeper into Amphastar Pharmaceuticals, you'd also look into what risks it is currently facing. To help with this, we've discovered 3 warning signs (1 is significant!) that you ought to be aware of before buying any shares in Amphastar Pharmaceuticals. Today we've zoomed in on a single data point to better understand the nature of Amphastar Pharmaceuticals' profit. But there are plenty of other ways to inform your opinion of a company. For example, many people consider a high return on equity as an indication of favorable business economics, while othe...

Investor releaseQuarter not tagged2026-05-11

Earnings Miss: Amphastar Pharmaceuticals, Inc. Missed EPS By 75% And Analysts Are Revising Their Forecasts

Simply Wall St.

There's been a notable change in appetite for Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) shares in the week since its first-quarter report, with the stock down 16% to US$19.00. Statutory earnings per share fell badly short of expectations, coming in at US$0.14, some 75% below analyst forecasts, although revenues were okay, approximately in line with analyst estimates at US$171m. Following the result, the analysts have updated their earnings model, and it would be good to know whether they think there's been a strong change in the company's prospects, or if it's business as usual. With this in mind, we've gathered the latest statutory forecasts to see what the analysts are expecting for next year. We've found 21 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free. After the latest results, the six analysts covering Amphastar Pharmaceuticals are now predicting revenues of US$747.5m in 2026. If met, this would reflect a satisfactory 3.7% improvement in revenue compared to the last 12 months. Per-share earnings are expected to surge 20% to US$2.16. In the lead-up to this report, the analysts had been modelling revenues of US$754.7m and earnings per share (EPS) of US$3.27 in 2026. So there's definitely been a decline in sentiment after the latest results, noting the large cut to new EPS forecasts. Check out our latest analysis for Amphastar Pharmaceuticals The average price target fell 6.3% to US$25.17, with reduced earnings forecasts clearly tied to a lower valuation estimate. It could also be instructive to look at the range of analyst estimates, to evaluate how different the outlier opinions are from the mean. The most optimistic Amphastar Pharmaceuticals analyst has a price target of US$30.00 per share, while the most pessimistic values it at US$21.00. As you can see, analysts are not all in agreement on the stock's future, but the range of estimates is still reasonably narrow, which could suggest that the outcome is not totally unpredictable. One way to get more context on these forecasts is to look at how they compare to both past performance, and how other companies in the same industry are performing. We would highlight that Amphastar Pharmaceuticals' revenue growth is expected to slow, with the forecast 5.0% annualised growth rate until the end of 2026 being well below the historical 14% p.a. growth ove...

Investor releaseQuarter not tagged2026-05-08

Amphastar Pharmaceuticals, Inc. Q1 2026 Earnings Call Summary

Moby

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Performance was driven by a return to growth from recent product launches, which offset pricing and competitive pressures across legacy product lines. BAQSIMI revenue declined 15% despite an 8% increase in unit volume, primarily due to higher rebates and potential duplicate 340B pharmacy discounts. Primatene MIST maintained momentum with a 6.5% increase in store-level sales, reflecting sustained consumer adoption and brand strength in the OTC market. The company successfully launched AMP-007 (Ipratropium Bromide) in April as the first and only generic inhalation product of its kind currently on the market. Management is addressing margin compression by engaging third-party consultants to validate rebate claims and implementing a 3% list price increase for BAQSIMI. Vertical integration remains a core strategic advantage, allowing the company to maintain control over quality and costs while advancing complex biosimilars. Full-year corporate sales guidance is maintained at mid-single-digit to high single-digit unit growth, supported by the exclusive market position of AMP-007. BAQSIMI revenue growth expectations have been revised to flat or up low single-digits for 2026 due to ongoing pricing dynamics. The insulin aspart biosimilar (AMP-004) and GLP-1 ANDA programs remain on track for planned commercial launches in 2027. Management expects to begin withdrawing BAQSIMI from a handful of non-core international markets starting in July to optimize the portfolio, while remaining in most foreign countries and all top-selling markets. Next-generation proprietary programs in oncology and immunology are advancing toward IND submissions and clinical development. Gross margins were 71% in the first quarter of 2026, compared to 50% in the previous year, though the company noted this as a decline due to lower average selling prices for BAQSIMI and other higher-margin products., impacted by BAQSIMI pricing, lower sales of high-margin legacy products, and increased facility costs. R&D spending increased 33% to $26.7 million, including a $2 million upfront payment for a new corticotropin product license. G&A expenses rose 13% due to higher legal costs and the implementation of a new ERP system. Glucagon injection sales fell 5...

Investor releaseQuarter not tagged2026-05-08

Amphastar (AMPH) Q1 2026 Earnings Transcript

Motley Fool

Image source: The Motley Fool. Thursday, May 7, 2026 at 5 p.m. ET Chief Executive Officer — Dan Dischner Chief Financial Officer & Executive Vice President, Finance — William J. Peters Senior Vice President, Regulatory & Clinical Affairs — Tony Marrs Dan Dischner: Thank you, Paul. Good afternoon, everyone, and thank you for joining Amphastar Pharmaceuticals, Inc.'s first quarter 2026 earnings call. Before we begin, I would like to recognize the continued dedication of our employees across Amphastar Pharmaceuticals, Inc. Their commitment to ensuring reliable access to essential medicines remains central to who we are and how we operate. Our first quarter performance demonstrated the continued strength and balance of our underlying business amid a rapidly evolving market landscape, with solid commercial execution across our branded and differentiated portfolio, alongside meaningful progress in our pipeline. We are actively managing near-term pricing and competitive pressures across certain legacy products with discipline and focus, and we remain confident that the strategic investments we are making today in our branded portfolio, biosimilars, complex generic pipeline, and manufacturing infrastructure are building the foundation for durable long-term growth. We reported net revenues of approximately 1.712 billion dollars for the first quarter, reflecting a return to growth, driven primarily by contributions from recent product launches, while overall performance across the base business remained stable. We saw continued strength in key areas, partially offset by pricing pressure, product mix shift, and increased competition—trends that are broadly consistent with the current market environment. We continue to deploy capital towards initiatives that we believe will drive long-term growth, and while the full benefits of these investments are not yet visible in our financials, we remain confident in the value they will create. From a strategic perspective, our focus remains centered on three key priorities: one, strengthening the resilience of our business; two, expanding and optimizing our branded and differentiated portfolio; and three, advancing our pipeline of complex and proprietary products. First, strengthening the resilience of our core business. We continue to see variability in pricing and competitive intensity across certain legacy products. We remain...

Investor releaseQuarter not tagged2026-05-08

Amphastar Pharmaceuticals (AMPH) Q1 Earnings Lag Estimates

Zacks

Amphastar Pharmaceuticals (AMPH) came out with quarterly earnings of $0.42 per share, missing the Zacks Consensus Estimate of $0.7 per share. This compares to earnings of $0.74 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -40.28%. A quarter ago, it was expected that this specialty pharmaceutical company would post earnings of $0.97 per share when it actually produced earnings of $0.73, delivering a surprise of -24.74%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Amphastar, which belongs to the Zacks Medical - Generic Drugs industry, posted revenues of $171.17 million for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 0.27%. This compares to year-ago revenues of $170.53 million. The company has topped consensus revenue estimates three times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Amphastar shares have lost about 10.8% since the beginning of the year versus the S&P 500's gain of 7.6%. While Amphastar has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Amphastar was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of...

Investor releaseQuarter not tagged2026-05-08

Compared to Estimates, Amphastar (AMPH) Q1 Earnings: A Look at Key Metrics

Zacks

Amphastar Pharmaceuticals (AMPH) reported $171.17 million in revenue for the quarter ended March 2026, representing a year-over-year increase of 0.4%. EPS of $0.42 for the same period compares to $0.74 a year ago. The reported revenue represents a surprise of +0.27% over the Zacks Consensus Estimate of $170.71 million. With the consensus EPS estimate being $0.70, the EPS surprise was -40.28%. While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expectations to determine their next move, some key metrics always offer a more accurate picture of a company's financial health. As these metrics influence top- and bottom-line performance, comparing them to the year-ago numbers and what analysts estimated helps investors project a stock's price performance more accurately. Here is how Amphastar performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts: Net revenues- Primatene MIST: $29.76 million versus $28.92 million estimated by two analysts on average. Compared to the year-ago quarter, this number represents a +2.5% change. Net revenues- Epinephrine: $19.21 million versus the two-analyst average estimate of $16.71 million. The reported number represents a year-over-year change of +3.4%. Net revenues- BAQSIMI: $32.43 million versus the two-analyst average estimate of $40.83 million. The reported number represents a year-over-year change of -15.4%. Net revenues- Glucagon: $9.17 million versus $13.23 million estimated by two analysts on average. Compared to the year-ago quarter, this number represents a -56% change. Net revenues- Lidocaine: $13.46 million versus the two-analyst average estimate of $14.54 million. The reported number represents a year-over-year change of -1.4%. View all Key Company Metrics for Amphastar here>>> Shares of Amphastar have returned +17.2% over the past month versus the Zacks S&P 500 composite's +11.4% change. The stock currently has a Zacks Rank #3 (Hold), indicating that it could perform in line with the broader market in the near term. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Amphastar Pharmaceuticals, Inc. (AMPH) : Free Stock Analysis Report This article originally published on Zacks Investment Research (...

Investor releaseQuarter not tagged2026-05-08

Amphastar Pharmaceuticals Q1 Earnings Call Highlights

MarketBeat

Interested in Amphastar Pharmaceuticals, Inc.? Here are five stocks we like better. Q1 revenue was roughly flat at about $171.2 million, but profitability fell sharply—net income dropped to $6.4 million (from $25.3 million) and adjusted net income fell to $19.5 million—while the company repurchased $29.5 million of shares. BAQSIMI revenue fell ~15% to $32.4 million due to lower average selling prices driven by higher rebates and 340B discounts despite an ~8% rise in units; Amphastar is auditing potential duplicate 340B rebates, raised BAQSIMI list prices 3% effective May 1, and will gradually exit a few international markets. New-product momentum is driving outlook: AMP-007 (ipratropium inhalation) launched in April as the first generic on the market and is expected to be the biggest growth driver this year, while insulin-aspart and GLP‑1 biosimilar programs remain on track for 2027 commercialization. Top 2 Small Cap Healthcare Stocks to Buy Before Rate Cuts Amphastar Pharmaceuticals (NASDAQ:AMPH) reported first-quarter 2026 net revenues of approximately $171.2 million, up slightly from $170.5 million in the prior-year period, as recently launched products helped offset pricing pressure and increased competition across parts of its legacy portfolio. On the company’s earnings call, Senior Vice President of Corporate Communications Dan Dischner said the quarter reflected “continued strength and balance” in Amphastar’s underlying business despite a “rapidly evolving market landscape.” Dischner added that Amphastar is “actively managing near-term pricing and competitive pressures across certain legacy products” while continuing to invest in its branded portfolio, biosimilars, complex generics, and manufacturing infrastructure. → Berkshire Hathaway’s Record Cash Hoard: Why and What's Next? Promising Small Biotech Amphastar Sees Actionable Pullback BAQSIMI generated about $32 million in quarterly revenue, which Dischner said was impacted by “higher rebates, channel mix, and increased utilization of government programs,” dynamics he characterized as industry-wide. He noted that underlying demand remained positive, with U.S. unit volumes increasing approximately 8% year-over-year. CFO Bill Peters provided additional detail, stating BAQSIMI revenue decreased 15% to $32.4 million from $38.4 million a year ago due to lower average selling prices, partially offset by th...

Investor releaseQuarter not tagged2026-05-08

Amphastar Pharmaceuticals Reports Financial Results for the Three Months Ended March 31, 2026

ACCESS Newswire

Net revenues of $171.2 million for the three months ended March 31, 2026 GAAP net income of $6.4 million, or $0.14 per share, for the first quarter Adjusted non-GAAP net income of $19.5 million, or $0.42 per share, for the first quarter Company to hold a conference call today at 2:00 p.m. Pacific Time RANCHO CUCAMONGA, CA / ACCESS Newswire / May 7, 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 ended March 31, 2026. "In the first quarter of 2026, we continued to strengthen our commercial foundation and core business, highlighted by the approval and subsequent launch of Ipratropium Bromide HFA, while also making meaningful advancements across our pipeline that will support our long‑term strategy," said Dr. Jack Zhang, Amphastar's President and Chief Executive Officer. "To begin the year, we broadened our portfolio through an exclusive license agreement for a fully synthetic corticotropin compound. At the same time, we remain committed to investing in our proprietary pipeline and capabilities, which we believe will support sustainable long-term growth." ________________________________ * Adjusted non-GAAP net income and adjusted non-GAAP diluted EPS are non-GAAP financial measures. Please see the discussion in the section entitled "Non-GAAP Financial Measures" and the reconciliation of GAAP to non-GAAP financial measures in Table III of this press release. First Quarter Results Changes in net revenues as compared to the first quarter of the prior year were primarily driven by: BAQSIMI® sales decreased primarily due to a lower average selling price, as a result of a change in gross-to-net discounts due to changes in chargebacks and rebates and changes to the customer mix, impacting sales of approximately $8.0 million. This decrease was partially offset by an increase in unit volumes, contributing $2.0 million in sales driven by our continued marketing efforts Primatene MIST® sales increased due to an increase in unit volumes Epinephrine sales increased primarily due to an increase in demand for our epinephrine pre-filled syringe, as a result of other supplier shortages, contributing $4.1 million in sa...

Investor releaseQuarter not tagged2026-05-08

Amphastar: Q1 Earnings Snapshot

Associated Press

RANCHO CUCAMONGA, Calif. (AP) — RANCHO CUCAMONGA, Calif. (AP) — Amphastar Pharmaceuticals Inc. (AMPH) on Thursday reported first-quarter earnings of $6.4 million. On a per-share basis, the Rancho Cucamonga, California-based company said it had net income of 14 cents. Earnings, adjusted for one-time gains and costs, were 42 cents per share. The results fell short of Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for earnings of 70 cents per share. The specialty pharmaceutical company posted revenue of $171.2 million in the period. Amphastar shares have dropped 10% since the beginning of the year. In the final minutes of trading on Thursday, shares hit $24.03, a fall of nearly 2% in the last 12 months. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on AMPH at https://www.zacks.com/ap/AMPH

TranscriptFY2026 Q12026-05-07

FY2026 Q1 earnings call transcript

Earnings source - 42 paragraphs
Operator

Greetings and welcome to the Amphastar Pharmaceuticals first quarter earnings call. Please 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 in the presentation on the company's website. Also, please refer to our SEC filings, which can be found on our company's website and the SEC website for a discussion of numerous factors that may impact our future performance.

Operator

We will also discuss certain non-GAAP measures. Important information on our use of these measures and reconciliations to US GAAP may be found in our earnings release. Please note this conference is being recorded. Our speakers today are Mr. Bill Peters, CFO, Mr. Dan Dischner, Senior Vice President of Corporate Communications, and Mr. Tony Marrs, Executive Vice President of Regulatory Affairs and Clinical Operations. I will now turn the conference over to your host, Mr. Dan Dischner, Senior Vice President of Corporate Communications. Dan, you may begin.

Dan Dischner

Thank you, Paul. Good afternoon, everyone, and thank you for joining Amphastar's first quarter 2026 earnings call. Before we begin, I'd like to recognize the continued dedication of our employees across Amphastar. Their commitment to ensuring reliable access to essential medicines remains central to who we are and how we operate. Our first quarter performance demonstrated the continued strength and balance of our underlying business amid a rapidly evolving market landscape. With solid commercial execution across our branded and differentiated portfolio, alongside meaningful progress in our pipeline. We are actively managing near-term pricing and competitive pressures across certain legacy products with discipline and focus, and we remain confident that the strategic investments we are making today in our branded portfolio, biosimilars, complex generic pipelines, and manufacturing infrastructure are building the foundation for durable long-term growth.

Dan Dischner

We reported net revenues of approximately $171.2 million for the first quarter, reflecting a return to growth, driven primarily by contributions from recent product launches, while overall performance across the base business remained stable. We saw continued strength in key areas, partially offset by pricing pressure, product mix shifts, and increased competition, trends that are broadly consistent with the current market environment. We continue to deploy capital towards initiatives that we believe will drive long-term growth. While the full benefits of these investments are not yet visible in our financials, we remain confident in the value they will create. From a strategic perspective, our focus remains centered on three key priorities. One, strengthening the resilience of our business. Two, expanding and optimizing our branded and differentiated portfolio. Three, advancing our pipeline of complex and proprietary products.

Dan Dischner

First, strengthening the resilience of our core business. We continue to see variability in pricing and competitive intensity across certain legacy products. We remain disciplined in managing costs and focusing on operational efficiency, ensuring supply reliability, and maintaining our position in essential product categories. This stability provides the foundation that supports both our near-term performance and our ability to invest in future growth. Second, expanding and optimizing our branded and differentiated portfolio. Products such as BAQSIMI and Primatene MIST remain center to our long-term growth strategy and continue to demonstrate underlying demand in the first quarter. BAQSIMI generated approximately $32 million in revenue this quarter. While reported revenue was impacted by higher rebates, channel mix, and increased utilization of government programs, these dynamics did not reflect the underlying demand.

Dan Dischner

It is also important to note that rebate pressure across these channels is an industry-wide dynamic and not unique to our portfolio. Demand trends remain positive, with U.S. sales unit volumes increasing approximately 8% year-over-year. We are actively addressing these factors through investments in rebate management, contracting strategy, and program optimization. We expect these pressures to moderate over time and remain confident in BAQSIMI's long-term growth trajectory. Primatene MIST generated approximately $30 million in revenue in the quarter, with performance driven by sustained consumer demand, continued commercial investment, and brand strength. The brand maintained strong momentum, with store-level sales increasing approximately 6.5% year-over-year, reflecting incremental consumer adoption and an ongoing impact of our marketing programs. We recently received FDA approval for AMP-007, our ipratropium bromide inhalation product, and successfully launched the product in April.

Dan Dischner

The launch is progressing as planned and reinforces our ability to execute across development, regulatory approval, manufacturing, and commercialization in technically complex product categories. Importantly, our product is currently the first and only generic ipratropium inhalation product on the market, which we believe positions us for a meaningful near-term commercial opportunity. Third, advancing our pipeline of complex and proprietary products. We are continuing to expand our efforts towards higher value opportunities, including proprietary and biosimilar programs, which now represent a significant and growing portion of our pipeline. Our strategy is built on a foundation that we have developed over many years, combining regulatory expertise, vertically integrated manufacturing, and commercial capabilities to efficiently advance complex products from development through commercialization. This integrated platform allows us to move efficiently while maintaining control over quality, timelines, and cost.

Dan Dischner

We continue to make steady progress across key programs, including our insulin aspart biosimilar and our GLP-1 ANDA program, both of which remain on track for planned commercial launches in 2027. At the same time, we continue to develop our next-generation proprietary assets, including programs in oncology and immunology. While these programs remain in early stages, we are encouraged by the progress to date and are focused on advancing them through IND submissions and into clinical development. Together, these efforts reflect our broader objective of expanding into higher-value therapeutic areas over time. Our continued investment in these programs is underpinned by a strong financial position. The cash flow generated by our commercial portfolio supports ongoing internal R&D while allowing flexibility in how we allocate capital. This enables us to advance our proprietary programs in a disciplined manner without relying on external financing or partnerships.

Dan Dischner

We also continue to actively evaluate targeted acquisitions and licensing opportunities that align with our existing capabilities, and our balance sheet provides the capacity to pursue these in a disciplined and selective manner. Looking ahead, we expect the operating environment to remain dynamic, particularly regarding pricing and competitive pressures. Against this backdrop, we are focused on disciplined execution while continuing to invest in the capabilities that underpin our long-term strategy. We believe this balanced approach, grounded in diversification, operational rigor, and sustained investment in our proprietary pipeline, positions us to navigate near-term variability and support durable long-term growth. Over the next 12 to 18 months, we expect continued contribution from our commercial portfolio, supported by BAQSIMI, Primatene MIST, and the recent launch of our ipratropium bromide. In parallel, we are focused on executing the next phase of our pipeline strategy with several important regulatory and development milestones ahead.

Dan Dischner

This includes progress across our biosimilar programs as well as our continued advancement of our emerging proprietary assets, which we believe are centered to the long-term growth profile. We have updated the corporate presentation on our website with timelines for our proprietary candidates. I will now turn the call over to Bill Peters, our CFO and Executive Vice President of Finance, for a more detailed financial review of the first quarter.

Bill Peters

Thank you, Dan. Good afternoon, everyone. In my comments today, I will discuss the first quarter results and then update some of our assumptions for 2026. Revenues for the first quarter increased to $171.2 million from $170.5 million in the previous year's period. BAQSIMI revenues decreased 15% to $32.4 million compared to $38.4 million in the prior year period as a result of lower average selling prices, which were partially offset by an 8% increase in units sold. The lower average selling price of BAQSIMI was driven by higher rebates and higher 340B pharmacy discounts, some of which may have been duplicated.

Bill Peters

Primatene MIST sales grew to $29.8 million in the first quarter, up 2% from $29.1 million in the first quarter of last year. epinephrine sales increased 3% to $19.2 million from $18.6 million as increased demand for our prefilled syringe product was partially offset by increased competition for our multidose vial products. glucagon injection sales declined 56% to $9.2 million from $20.8 million due to increased competition and a shift to ready-to-use products.

Bill Peters

Other finished pharmaceutical product sales increased 34% to $67.1 million from $50 million, primarily due to recently launched products, including an increase in albuterol sales of $2.8 million, iron sucrose sales of $1.4 million, and teriparatide sales of $2.2 million, which we launched in August 2024, August 2025, and December 2025, respectively. dextrose sales also increased due to shortages from other suppliers while phytonadione sales declined due to increased competition. Cost of revenues increased to $100.8 million from $85.3 million. Gross margins declined to 71% of revenues in the first quarter of 2026 from 50% in the previous year.

Bill Peters

The primary drivers of the change were a lower average selling price for BAQSIMI, as well as lower sales of glucagon, phytonadione, and epinephrine multidose vials, which are higher-margin products. Additionally, increased costs at our Amphastar facility negatively impacted margins. Selling, distribution, and marketing expenses were relatively unchanged at $11.9 million. General and administrative spending increased 13% to $18 million from $16 million driven by higher legal expenses, salary and personnel-related expenses, and expenses related to the implementation of our new ERP system. Research and development expenditures increased 33% to $26.7 million from $20.1 million due to the $2 million upfront payment made to in-license a new corticotropin product and spending on our insulin, inhalation, and proprietary product pipeline.

Bill Peters

Our non-operating expense of $3.6 million compares to a non-operating expense last year of $6.4 million, primarily due to foreign currency fluctuations as well as mark-to-market adjustments related to our interest rate swap contracts in the quarter. Net income decreased to $6.4 million or $0.14 per share in the first quarter from $25.3 million or $0.51 per share in the first quarter of 2025. Adjusted net income decreased to $19.5 million or $0.42 per share compared to an adjusted net income of $36.9 million or $0.74 per share in the first quarter of last year. Adjusted earnings exclude amortization, equity compensation, and one-time events. In the first quarter, we had cash flow from operations of approximately $47.8 million.

Bill Peters

During the quarter, we accelerated our share repurchase program and bought back $29.5 million worth of shares, which represents about 3% of our share count. Before I turn the call back over to Dan, I would like to update some of our guidance for 2026. We now believe that BAQSIMI revenue growth will be flat to up low single-digit percentages compared to last year due to the previously mentioned pricing pressures. In response to these pricing dynamics, we have taken additional steps to strengthen the durability of this business, including engaging a third party to support data-driven identification, validation, and resolution of potential 340B duplicate discounts. Additionally, we've implemented a 3% list price increase on BAQSIMI as of May 1st.

Bill Peters

Importantly, even with this revised outlook for BAQSIMI, we are maintaining our overall corporate sales guidance of mid-single digit to high single-digit unit growth. This reflects the strength of our broader portfolio, including ipratropium bromide inhalation, which we launched in April and currently does not face any generic competitors. I'll now turn the call back over to Dan.

Dan Dischner

Thanks, Bill. In summary, our first quarter performance reflects our resilience and ability to execute in a dynamic market and environment. Growth was supported by new product launches and stable performance across our base portfolio while actively managing pricing and competitive pressures. BAQSIMI and Primatene MIST continue to demonstrate solid underlying demand, and we are taking targeted actions to improve net pricing and optimize performance over time. The recent approval and launch of our ipratropium bromide inhalation product adds an important near-term growth driver. We remain on track with late-stage programs, including our insulin aspart biosimilar and our GLP-1 ANDA, both expected in 2027, while continuing to advance our early-stage proprietary pipeline. With a strong financial position, we are focused on executing against our strategy, navigating near-term variability, and positioning the business for sustained long-term growth. With that, we will now take your questions. Operator?

Operator

Thank you. We'll now be conducting a question-and-answer session. Thank you. Our first question is from Serge Belanger with Needham & Company.

Serge Belanger

Hey, good afternoon. A couple questions on BAQSIMI. Obviously, there were some headwinds in the first quarter. Just curious how much of it was seasonality peculiar to the first quarter? How much of it will continue to linger into the continuing quarters here? Specifically on price, can you talk about the price decrease and where you think you can get it to with the activities you'll be undertaking? Last one on BAQSIMI. In the past, you had talked about discontinuing commercialization in some international markets. Has that started to occur, and what impact would that have on sales levels? Thank you.

Bill Peters

The pricing issue that we've been encountering appears to be potentially, you know, there's multiple things going on there. One, there's some increased rebates, but also potentially, we believe some duplicate rebates, which seems to be a 340B pharmacy issue. What we've undertaken is to engage an outside consultant or outside firm to basically validate these claims before they're paid. We believe that in doing that, we will stop that practice. We just, you know, engaged that firm and that process began at the beginning of May. That trend continues into April, but we hope that changes in May. Additionally, the 3% price increase that we took is also effective May 1st.

Bill Peters

We believe that we could get at least partway back to the pricing where we were last year, or most of the way back by later this year, but part of the way back this quarter. Seasonality did not have anything to do with that. As far as the discontinuation from certain international markets, we've talked about withdrawing from a handful of markets. That situation is that we have given notice in some countries that require a lengthy notice period. Also we have some inventory in other countries that we plan to discontinue.

Bill Peters

The discontinuation would begin in July, but it's not going to be all at once because some, like I said, some countries are going to have inventory that might extend into August or September, and others with a notice period requirement will keep selling probably through the end of this year and into the first quarter of next year. It's not going to be a fall off. Remember, we've also characterized this as, you know, 80% of our sales were in the United States last year, only 20% were foreign, and we're only going to drop out of a handful of countries out of the 20-something foreign countries. We're going to remain in most of the foreign countries, including all of the top-selling markets. It's not going to be a significant decrease in the third quarter.

Bill Peters

Also the other way to think about it is that, you know, last year, U.S. sales were 80%. This year, they're probably gonna be closer to 85%.

Serge Belanger

Thank you.

Operator

Our next question is from Dennis Ding.

Speaker 5

Hi, this is Anthea on for Dennis. Thanks for taking our questions. We just had two on the pipeline. First, on the synthetic corticotropin, I see in your slides that you're thinking to go into phase I in 2027. I'm curious if you've met with the FDA and had, like, regulatory alignment there, and whether there could be an accelerated path. Then second, any updates on AMP-004, the insulin aspart? I think the prior PDUFA was planned for Q4 2026, just curious on any additional color there. Thank you.

Bill Peters

I'll take the first one, the update on AMP-004. It's still in progress and nothing's changed. We still plan on commercializing it in 2027. On your other question regarding Tony, can you take that one? Sure. For AMP-110, we have not met with the agency for that. We think the possibility is there for among these pipeline products for expedited approvals. We haven't met with the agency and we don't have alignment with them on that.

Speaker 5

Okay. Thank you.

Operator

Our next question is from Ekaterina Knyazkova with J.P. Morgan.

Ekaterina Knyazkova

Thank you so much. Actually, another one on AMP-004. Just can you remind us how you're thinking about the size of that opportunity and just, you know, how quickly it could ramp in 2027? Second question is just on glucagon. Is the Q1 number a good kind of tail end for the product, or would you expect sequential erosion from that Q1 number? Thank you.

Bill Peters

Yeah. For the first one, you know, this is a product that, you know, still has over $1 billion in sales. We think that it's gonna be a relatively large product for us and a meaningful product for us when we launch that. We do think it'll take a little time to get sales, and also will depend on whether we have the interchangeability or not, which we would like to get right away. There's gonna be a couple different drivers, and we should have a little more idea of that timing and pathway, you know, next year. And as far as glucagon, I will say that no, we have not reached the bottom of that yet.

Bill Peters

I'll say the rate of decline is slowing significantly. It will decline from here, but not at the same rate that it's been declining.

Operator

Our next question is from David Amsellem with Piper Sandler.

Speaker 6

Thanks for taking my question. This is Nakion for David. First on Primatene MIST, how should we think about generic competition, and do you have any updates regarding lifecycle management? That's number one. Number two, how should we think about revenue contribution from AMP-007 and the extent of the opportunity here? Thank you.

Bill Peters

With the Primatene MIST, we have not been notified or have no visibility on whether or not there is a generic in place. We've always taken the position that we believe it would be very difficult to genericize this product. Primatene MIST has 60 years of brand recognition. You know, it's over the counter. It would be difficult regulatory-wise. Because it's retail and it's over the counter, it has different market dynamics than what you would see with a typical generic. We haven't really. We have no visibility outside of that. As far as our next generation, we have, as we said, in our pipeline, we have a green version that we're working on.

Bill Peters

We have one patent already and another one pending, and we continue to advance that through development. On AMP-007, we haven't given a sales forecast on that. However, we have said that that would be our biggest growth driver this year, and we had a couple different scenarios. We said that even when we thought that there might be a generic competitor on the market with us. As of today, there isn't, and we launched this in mid-April. Right now we're almost a month into it without a generic competitor.

Bill Peters

That's one of the reasons why we're able to maintain our high mid-single digit to high single digit sales growth guidance for the year is that believe that this product will outpace our original assumptions.

Speaker 6

Great. Thank you.

Operator

There are no further questions at this time. I would like to hand the floor back over to management for any closing remarks.

Dan Dischner

Thank you, Paul. Thank you all for your questions and your continued interest in Amphastar. We remain focused on executing against our strategy and advancing the initiatives we discussed today. We appreciate your continued support and look forward to updating you on our progress next quarter. Have a great day.

Operator

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.

As of 2026-05-30 • Updated weeklySource: Earnings sourceIngestion runbook