NASDAQ:AMPH Amphastar Pharmaceuticals Q2 2026 Earnings Report $20.87 +0.69 (+3.44%) As of 12:34 PM Eastern This is a fair market value price provided by Massive. Learn more. ProfileEarnings HistoryForecast Amphastar Pharmaceuticals EPS ResultsActual EPS$0.91Consensus EPS $0.62Beat/MissBeat by +$0.29One Year Ago EPSN/AAmphastar Pharmaceuticals Revenue ResultsActual Revenue$183.90 millionExpected Revenue$179.92 millionBeat/MissBeat by +$3.98 millionYoY Revenue GrowthN/AAmphastar Pharmaceuticals Announcement DetailsQuarterQ2 2026Date8/6/2026TimeAfter Market ClosesConference Call DateThursday, August 6, 2026Conference Call Time5:00PM ETConference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress Release (8-K)Quarterly Report (10-Q)SEC FilingEarnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by Amphastar Pharmaceuticals Q2 2026 Earnings Call TranscriptProvided by QuartrAugust 6, 2026ShareShareShare This ReportLink copied to clipboard.Key Takeaways Positive Sentiment: Second-quarter revenue rose 5% year over year to $183.9 million, with gross margin improving to 51% as recently launched products, including ipratropium bromide, teriparatide, and iron sucrose, contributed higher-margin sales. Management maintained its 2026 corporate sales-growth outlook of mid-single-digit to high-single-digit growth. Positive Sentiment: Ipratropium bromide launched successfully in April, generating $8.4 million in quarterly sales, and management said the product is approaching its targeted 50%–80% market-share range. BAQSIMI prescriptions also increased 17% year over year, and the product exceeded its annual sales milestone, triggering a $100 million payment to Eli Lilly. Negative Sentiment: IMS received an FDA warning letter and expects an additional $2 million to $3 million per quarter in remediation expenses for the next several quarters, along with somewhat slower sales and possible production delays. Management does not currently expect a material impact on overall operations and said manufacturing and distribution are continuing. Negative Sentiment: Glucagon sales fell 42% year over year to $11.9 million because of intensified competition; management expects the decline to moderate but does not anticipate the product returning to growth. BAQSIMI sales also declined 3% because of lower pricing, rebates, and 340B discounts despite higher prescription volumes. Positive Sentiment: The company advanced several pipeline programs, including initiating a Phase I trial for AMP-101 epinephrine nasal spray and continuing preparations for its insulin aspart biosimilar, which remains on track for a potential 2027 launch subject to approval. Amphastar also repurchased approximately $45 million of shares during the quarter. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallAmphastar Pharmaceuticals Q2 202600:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Operator00:00:00Greetings. Welcome to the Amphastar Pharmaceuticals Inc. second 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 this conference, please press star zero on your telephone keypad. 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 section entitled Forward-Looking Statements in the press release issued today and the presentation on the company's website. Please refer to our SEC filings, which can be found on the company's website and the SEC's website, for a discussion of numerous factors that may impact our future performance. Operator00:00:51We will also discuss certain non-GAAP measures. Important information on our use of these measures and reconciliations to U.S. 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 DischnerSVP of Human Resources and Corporate Communications at Amphastar Pharmaceuticals00:01:24Thank you, Paul. Good afternoon, everyone. Thank you for joining Amphastar's second quarter 2026 earnings call. Earlier today, we reported the financial results for the second quarter ended June thirtieth, 2026, which are available on the Investors page of our website. The second quarter was marked by strong execution across each of our strategic growth pillars. We observed continued demand across our commercial portfolio. We expanded our manufacturing capabilities and advanced both our development pipeline and regulatory programs. As a result, we generated improved financial performance during the second quarter. Revenue increased to approximately $184 million, reflecting both sequential and year-over-year growth. Profitability also improved significantly from the first quarter, driven by increased revenue, margin expansion, and enhanced operating performance. Despite a dynamic operating environment, our strategic priorities have remained consistent. Dan DischnerSVP of Human Resources and Corporate Communications at Amphastar Pharmaceuticals00:02:27We continue to focus on building a diversified pharmaceutical company supported by three complementary growth pillars. First, expanding and optimizing our branded and differentiated commercial portfolio. Second, advancing our pipeline of complex generic and biosimilar products. Third, progressing our proprietary development programs that have the potential to create significant long-term value. We believe this diversified business model provides multiple avenues for growth, enhances resilience, and reduces our dependence on any single product, market, or revenue stream. Turning to the first pillar of our growth strategy, expanding and optimizing our branded and differentiated commercial portfolio. We continued to make meaningful progress during the second quarter. Products such as BAQSIMI and Primatene MIST remain central to our long-term strategy and continue to demonstrate strong consumer demand. BAQSIMI remained an important contributor to our business. Dan DischnerSVP of Human Resources and Corporate Communications at Amphastar Pharmaceuticals00:03:33Total prescriptions increased approximately 17% compared with the second quarter of last year, demonstrating continued growth in patient demand. BAQSIMI's net sales were approximately $45.5 million, a decrease of approximately 3% compared to the prior year quarter. The difference primarily reflects pricing, rebates, and commercial dynamics. Importantly, strong prescription growth continues to reinforce our confidence in the long-term strength of the franchise. In June, we also completed the third contract year following our acquisition of BAQSIMI from Eli Lilly. During the contract year, BAQSIMI generated $178.3 million in net sales, exceeding the $175 million threshold and triggering our first milestone payment to Lilly. Achieving this milestone reflects the continued strength of the franchise and the successful execution of our commercial strategy since acquiring the product. Dan DischnerSVP of Human Resources and Corporate Communications at Amphastar Pharmaceuticals00:04:35Our focus remains on expanding patient access, supporting continued prescription growth, and managing the business with disciplined commercial execution to maximize long-term value. Primatene MIST continued to demonstrate strong consumer demand during the quarter. Each in-store sales increased compared with both the prior year quarter and the first quarter of 2026, reflecting continued brand strength and market penetration. While reported net sales declined, the decrease was largely attributable to consumer ordering patterns and the timing of shipments associated with pricing discussions with certain retailers. We believe these were temporary channel-related effects rather than a change in consumer demand. Retail performance remained healthy throughout the quarter, reinforcing our confidence in the Primatene MIST franchise and the effectiveness of our marketing investments and commercial execution. At the same time, performance across our broader portfolio reflected the competitive dynamics that are characteristic of the generic pharmaceutical market. Dan DischnerSVP of Human Resources and Corporate Communications at Amphastar Pharmaceuticals00:05:44Glucagon sales declined compared with the prior year as a result of increased competition. We believe this underscores the importance of continuing to diversify our commercial portfolio and advance new products, which can create multiple sources of growth and enhance the resilience of our business over the long term. Furthermore, during the quarter, our manufacturing facility, Armstrong, benefited from the successful launch of our ipratropium bromide product in April. The launch further demonstrates our ability to advance technically complex generic products from development through regulatory approval and into commercial production, reinforcing a core capability that differentiates our platform. Based on early demand and the current competitive landscape, we believe ipratropium bromide represents an attractive long-term opportunity for Amphastar. We continue to invest strategically across our U.S. manufacturing network to strengthen quality and efficiency, expand automation and capacity, and prepare for upcoming pipeline products. Dan DischnerSVP of Human Resources and Corporate Communications at Amphastar Pharmaceuticals00:06:50As policymakers and consumers place greater emphasis on domestic pharmaceutical manufacturing and supply chain resilience, we believe our U.S.-based manufacturing footprint, combined with our vertically integrated development and commercialization capabilities, represents a meaningful competitive advantage. These investments not only support our current commercial portfolio, but also provide a strong foundation for future product launches and sustainable long-term growth. IMS, one of our subsidiaries, recently received an FDA warning letter related to the FDA inspection conducted in December 2025. Since the inspection, IMS has continued implementing corrective actions. We have responded to the FDA in a timely manner regarding our remediation plan and continue to work closely with the agency to address the items identified in the warning letter. The warning letter does not require IMS to stop manufacturing or distributing its products. Dan DischnerSVP of Human Resources and Corporate Communications at Amphastar Pharmaceuticals00:07:50While the remediation effort will require additional resources, at this time, we do not currently anticipate a material adverse effect on Amphastar's overall business operations, commercial portfolio, development pipeline, or sales. We remain committed to addressing the FDA's observations thoroughly and sustainably. Quality remains a fundamental responsibility throughout Amphastar, and we will continue strengthening the overall effectiveness of our quality systems. Turning to our third pillar of growth strategy, advancing our development pipeline, we continue to achieve important regulatory and clinical milestones during the second quarter. For our insulin aspart biosimilar and interchangeable program, we continue preparing for potential commercialization in 2027, subject to regulatory approval. We have also made meaningful progress with our proprietary pipeline. During the second quarter, we initiated the phase I clinical program for AMP-101, our epinephrine nasal product. For AMP-109, our targeted oncology program, non-clinical studies are underway. Dan DischnerSVP of Human Resources and Corporate Communications at Amphastar Pharmaceuticals00:09:02During the quarter, we received constructive feedback from the FDA and are continuing preparation for regulatory interactions in the near future and an anticipated IND submission. Development activities are ongoing for AMP-110, our synthetic human corticotropin program, and AMP-107, our eye drop program for wet age-related macular degeneration and diabetic macular edema, as we look to advance both towards a future IND submission. While these programs remain in early stages of development, we believe they represent meaningful long-term opportunities. Leveraging our scientific, regulatory, and manufacturing capabilities, these programs have the potential to expand our presence into larger proprietary markets and create additional drivers of future growth and value creation. 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 second quarter. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:10:06Thank you, Dan, and good afternoon, everyone. In my comments today, I will discuss the second quarter results and then update some of our assumptions for 2026. Revenues for the second quarter increased 5% to $183.9 million from $174.4 million in the previous year's period. Ipratropium Bromide Inhalation, which we launched in April, led to growth with strong sales of $8.4 million. BAQSIMI revenues decreased 3% to $45.5 million, compared to $46.7 million in the prior year. An increase in units sold, contributing $6.9 million in sales, was driven by our continued marketing efforts. Lower average selling prices negatively impacted sales by approximately $8.1 million, primarily as a result of higher rebates and higher 340B pharmacy discounts, some of which may have been duplicated. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:11:05In May, in response to these pricing dynamics we had seen over the past few quarters, we engaged a third party to support data-driven identification, validation, and resolution of potential 340B duplicate discounts, which led to a smaller impact than we saw in the first quarter. Primatene sales were $21 million in the second quarter, down 8% from $22.9 million in the second quarter of last year due to the timing of customer purchases. Epinephrine sales were relatively flat, as weakness in the vial product was offset by increased demand for our pre-filled syringe product. Glucagon sales declined 42% to $11.9 million from $20.6 million due to increased competition. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:11:51Sales of other products increased 25% to $66.2 million from $53.1 million, primarily due to recently launched products, including iron sucrose, with sales of $3.5 million, and teriparatide, with sales of $4.5 million, which we launched in August 2025 and December 2025, respectively. An increase in albuterol sales of $2.4 million, which we launched in 2024, also contributed to the increase. Additionally, an increase in phytonadione and sodium bicarbonate sales, driven by higher demand resulting from supplier shortages, and an increase in sales of API from our AMP subsidiary, had a positive impact on sales. Cost of revenues increased 3% to $90.4 million from $87.9 million. Gross margins increased to 51% of revenues in the second quarter of 2026 compared to 50% in the previous year period. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:12:53The primary drivers of the change were sales of recently launched products with higher margins such as ipratropium bromide, teriparatide, and iron sucrose. This trend was partially offset by a lower average selling price for BAQSIMI, glucagon, and epinephrine multidose vials. Additionally, we had increased manufacturing costs at our Amphastar facility. Selling, distribution, and marketing expenses increased 30% to $13.3 million from $10.2 million, primarily due to an increase in marketing efforts for BAQSIMI and higher freight expenses. General and administrative spending increased 30% to $18.2 million from $14 million, driven by higher legal expenses, salary and personnel-related expenses, as well as expenses related to the implementation of a new ERP system. Research and development expenditures increased 10% to $22.2 million from $20.1 million, primarily due to an increase in clinical trial expense, largely for our insulin pipeline. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:13:56Our non-operating expense of $1.2 million during the period compares to a non-operating expense of $2.8 million in the prior year period, primarily due to foreign currency fluctuations and mark-to-market adjustments related to our interest rate swap contract during the quarter. Net income decreased slightly to $30.3 million, but increased on a per-share basis to $0.67 in the second quarter from $31 million, or $0.64 per share in the second quarter of 2025. Adjusted net income was relatively flat at $40.8 million, but increased on a per-share basis to $0.91 in the second quarter compared to an adjusted net income of $40.9 million or $0.85 per share in the second quarter of last year. Adjusted earnings excludes amortization, equity compensation, and one-time events. In the second quarter, we had cash flow from operations of approximately $51.3 million. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:14:53During the quarter, we accelerated our share repurchase program and bought back approximately $45 million worth of shares. Separately, in June, we achieved the first annual BAQSIMI net sales milestone under our asset purchase agreement with Eli Lilly, which triggers a $100 million payment due in the third quarter of 2026. Before I turn the call back over to Dan, I would like to update some of our guidance for 2026. Due to remediation efforts at our IMS facility, we expect expenses there will increase by $2 million to $3 million per quarter for the next several quarters. Capital expenditures will also increase at this facility, but there will be no change to our previously communicated capital expenditure profile as we redirect spending from our Amphastar facility to our IMS facility. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:15:45We also expect a slight slowing of sales from IMS as we concentrate on addressing corrective actions, thus improving the quality and manufacturing systems. Importantly, even with this revised outlook, we maintain our overall corporate sales guidance of mid-single digit to high single-digit sales growth, reflecting the strength of our broader portfolio. I will now turn the call back over to Dan. Dan DischnerSVP of Human Resources and Corporate Communications at Amphastar Pharmaceuticals00:16:09Thank you, Bill. Looking ahead, our priorities remain clear. We are focused on supporting continued growth across our commercial portfolio, expanding our U.S. manufacturing capabilities, completing the IMS remediation activities, advancing our near-term regulatory programs, and continuing disciplined investment in our proprietary pipeline. We believe the second quarter highlighted the strength and resilience of Amphastar's diversified business model. Dan DischnerSVP of Human Resources and Corporate Communications at Amphastar Pharmaceuticals00:16:37Faced with a dynamic operating environment, we delivered improved financial performance, generated continued demand across our key commercial brands, and achieved important regulatory and development milestones. These results reflect the benefits of our diversified growth strategy and the balanced foundation we have built across our commercial portfolio, development pipeline, and manufacturing platform. We also believe Amphastar is well-positioned for the evolving pharmaceutical landscape. Our diversified product portfolio, our U.S.-based finished product manufacturing footprint, vertically integrated capabilities, and growing development pipeline provide multiple avenues of growth and support long-term value creation. Dan DischnerSVP of Human Resources and Corporate Communications at Amphastar Pharmaceuticals00:17:21With that, we will now take your questions. Paul? Operator00:17:27Thank you. We'll now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we call for questions. Thank you. Our first question is from Ekaterina Knyazkova with JPMorgan. Ekaterina KnyazkovaEquity Research Associate at JPMorgan00:18:02Thanks so much. First question is just on operating costs. Can you just elaborate a bit on how we should think about spend from here and what both R&D and SG&A could look like over the next several quarters? A related question just on adjusted gross margins. Seems like there's been quite a bit of volatility in that number over the past few quarters. Just what's been driving that, and what's a good baseline to use for gross margins in the second half of the year? Thanks. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:18:24Yes. There's a couple things driving the decrease in the first quarter. The primary thing was the BAQSIMI double dip counting that we saw there. That had a pretty negative impact. We had some better impacts in the second quarter as we began some procedures to mitigate that and hired an independent party that's going to help reduce that double discount. The second thing in the second quarter was that we had the launch of Ipratropium Bromide HFA, which is a higher margin product, that really helped out a lot. On a going forward basis, I would expect to see the coming quarter similar to this quarter, because remember, we'll have higher BAQSIMI sales next quarter, those higher sales should offset some of the costs that we're expecting at IMS. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:19:13Additionally, on the G&A and selling expense, I think the second quarter is also a good comp for those. The R&D expense, we do expect that to tick up a little bit as a percentage of sales on a going forward basis. Ekaterina KnyazkovaEquity Research Associate at JPMorgan00:19:32Thanks. Operator00:19:36Our next question is from Dennis Ding with Jefferies. Dennis DingSVP and Analyst at Jefferies00:19:41Hi. Thanks for taking the questions. I have two questions. Number one, remind us what's going on with the IMS facility that got the warning letter. If I recall, you guys probably responded to it in late July. Remind us the revenue exposure here again from this facility, what are the next steps from the FDA and when, and then would remediation plans require shutting down some of the production lines? That's question number one. Question number two, on BAQSIMI's 340B dynamic, I think you said 80% of that pricing pressure can ultimately go away. Can you reiterate that number on the call today, and how much of that 80% was recovered in Q2, and how much is left to recover in Q3? Thanks so much. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:20:30Okay. Let me start with the revenue. IMS makes, the sales are probably about a third of our overall corporate sales on a big picture. However, we are still shipping there. We don't expect to stop shipping there. We still are producing at the same rate that we've been. We have taken some quality steps which have slowed down some of the releases, some of the batches right now to make sure that they've gone through an extra quality review, so that's led to a small delay right now for that. I'll turn it over to Tony for some of the other next steps that we have going on there. Tony MarrsEVP of Regulatory Affairs and Clinical Operations at Amphastar Pharmaceuticals00:21:12Yeah. As you mentioned, we did respond to the warning letter in late July. Essentially the way these are is you have an interaction where you update the FDA on a routine basis, generally every month or two, just to go over your plan and the program. We've hired a third-party independent consultant that has great experience in helping to work with these kind of projects. We'll continue to just work with them and if there are any remediation efforts, we'll work with them and keep the FDA in the loop with that. If there are any shutdowns, as you mentioned, which is definitely a possibility, we'll do those as needed. We routinely do those now. Whether it's a little bit longer or not remains to be depending on what they find during the remediation and during the assessments. Tony MarrsEVP of Regulatory Affairs and Clinical Operations at Amphastar Pharmaceuticals00:22:14We do routinely have those, unlikely at this point. We don't have any expectation that there'll be any of those, again, it sort of remains to be seen based on the assessments. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:22:28going back to the last question on BAQSIMI on the 340B. We just implemented that consultant, or that firm that helps us with this in May. We only covered two months, and I'll say not all of their actions took place right away. When we talked about reducing 80% of the double-dipping on the last call, I'd say that we probably are halfway there at this point. Dennis DingSVP and Analyst at Jefferies00:22:59Thank you. Operator00:23:03Our next question is from David Amsellem with Piper Sandler. Malcolm ArmourResearch Associate at Piper Sandler00:23:09Hi, this is Malcolm Armour for David. Thank you for taking our questions. First, with respect to BD, is your priority acquiring immediately accretive commercial products, or would you accept some development spending for a differentiated late-stage asset? That's number one. Number two, also with respect to BD, are you willing to establish a new commercial organization in a new vertical or will any potential targets need to leverage existing commercial infrastructure? Thank you. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:23:35Yeah. Good question. As far as the development goes, we have been looking at both development programs and things that would be immediately accretive or soon to be accretive, I'll say, things that are very late stage, essentially filed. Right now, because we in-licensed three products last year that are early stage, our real focus and what we prefer to look at are things that would be either immediately accretive or accretive to earnings within a year. That's the strong preference. However, we're looking at multiple things, and if we saw the right thing that was an early stage, we'd probably do that. I think the cost structure of those is very different. For example, when we took a look at the four products that we in-licensed last year, the upfront cost was $2 million each. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:24:29Much, much lower than a BAQSIMI or something else that's already on the market. As far as new commercial verticals, we would consider new commercial verticals, but they would probably be in the areas where we have either some kind of planned product, such as the in-license assets that are in oncology, ophthalmology, and immunology. Those are the three areas that we would consider new verticals, in addition to the endocrinology where we have BAQSIMI. I don't see us moving outside of those verticals. Malcolm ArmourResearch Associate at Piper Sandler00:25:07Thank you. Operator00:25:12Our next question is from Serge Belanger with Needham & Company. Analyst at Needham & Company00:25:19Hi, this is John on for Serge today. Thanks for taking our questions. Just a couple on your current product portfolio. The first being the generic Atrovent launch that came about in mid-April. I believe you've highlighted previously that you see this product capturing as much as 50%-80% of the market. Curious what the early stages of the launch have shown thus far and whether you've narrowed that market share goal at this time. Second, on glucagon, you highlighted that it's still seeing some competitive pressures. Although it increased a little bit in the second quarter over the first quarter, I'm curious if you think that this product is now at a stabilization period and could return to growth in the second half of the year. Thanks. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:26:11Yeah. Generic Atrovent, we've got a nice market share, and we are closing in on that goal range that we have put out there, but we're not quite there yet. We're really happy with where we are at this point, and that product launch has gone really well for us. As far as glucagon goes, we saw several new competitors come in over about an 18-month period, including all the way into late last year. Year-over-year, we haven't finished the decline. On a go-forward basis, that rate of decline, we think will diminish. The worst of that decline is over. However, we don't see this as becoming a growth product again. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:27:04In all likelihood, it's something where we're finding that we think that the portion of the market that's for diagnostic will grow slightly, but the portion that's for the anti-hypoglycemia will continue to decline somewhat. We don't see this as being a growth thing. It's going to decline. The decline is more muted than it's been over the last several quarters. Analyst at Needham & Company00:27:37Great. Thank you. Operator00:27:42Our next question is from Jason Gerberry with BofA Securities. Analyst at BofA Securities00:27:48Hi, this is Melanie on for Jason. Thanks for taking our question. Just on AMP-004, your insulin aspart. Based on current price levels and anticipated concessions, do you see the product gross margin being relative to corporate levels? Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:28:06Yes. This is something that we think will probably be at or slightly below the current corporate gross margin levels, given the competition that we see in those today. It is still being something where we have a fairly large sales potential for us. We think sales will be meaningful for us. Operator00:28:38Our next question is from Ben Burnett with Wells Fargo. Ken ShihAnalyst at Wells Fargo00:28:44Hi. Hello, this is Ken Shih on for Ben Burnett. Thanks for taking our questions. One question we have is that on the insulin aspart bioavailability study, recently it's shown up as completed on ClinicalTrials.gov. Is this something that you can touch on? What does the data look like? What is the path forward on this? Thank you. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:29:05Okay. Could you please repeat the question again? I think we were having a little hard time understanding. Ken ShihAnalyst at Wells Fargo00:29:12Oh, sorry. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:29:13Which product are you referring to? Ken ShihAnalyst at Wells Fargo00:29:17Yeah, sorry, let me repeat again. Yeah, it's the insulin aspart bioavailability study showing up recently on clinicalTrials.gov as completed. Is this something that you can touch on? Have you seen the data? What's the path forward in terms of resubmitting, et cetera? Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:29:38The question is about the trial. If you had seen on it's a bioequivalent PK type trial, and it's just measuring the AUC between the two products, the reference and the other one. I think that's what it is. What I'll say about that product is we're on schedule for that to have our commercial launch of the product next year in 2027. Ken ShihAnalyst at Wells Fargo00:30:13Thanks for the color. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:30:15Thanks. Operator00:30:19Thank you. There are no further questions at this time. I would like to hand the floor back over to management for any closing remarks. Dan DischnerSVP of Human Resources and Corporate Communications at Amphastar Pharmaceuticals00:30:26Thank you, Paul, and thank you all for the questions today. As highlighted in our remarks today, we remain focused on executing our long-term strategy, strengthening our commercial portfolio, advancing our pipeline, and continuing to invest in our U.S. manufacturing capabilities. Thank you for your continued interest in Amphastar. We appreciate your support and look forward to updating you on our progress next quarter. Operator00:30:54This concludes today's conference. You may disconnect your lines at this time. Thank you again for your participation.Read moreParticipantsExecutivesDan DischnerSVP of Human Resources and Corporate CommunicationsBill PetersEVP and CFOTony MarrsEVP of Regulatory Affairs and Clinical OperationsAnalystsEkaterina KnyazkovaEquity Research Associate at JPMorganDennis DingSVP and Analyst at JefferiesMalcolm ArmourResearch Associate at Piper SandlerAnalyst at Needham & CompanyAnalyst at BofA SecuritiesKen ShihAnalyst at Wells FargoPowered by Earnings DocumentsSlide DeckPress Release(8-K)Quarterly report(10-Q) Amphastar Pharmaceuticals Earnings HeadlinesAmphastar (AMPH) Q2 2026 Earnings Call TranscriptAugust 14 at 7:34 AM | finance.yahoo.comThe Top 5 Analyst Questions From Amphastar Pharmaceuticals’s Q2 Earnings CallAugust 13 at 10:10 AM | msn.comBSEM Is Officially on Nasdaq... The Next Chapter Begins!BioStem Technologies (NASDAQ: BSEM) debuted on Nasdaq August 7th, marking its move from OTC markets into a new phase of visibility for the regenerative medicine company. The company's acquisition of BioTissue assets expanded its Neox and Clarix product portfolios and strengthened hospital relationships, following seven consecutive profitable quarters and its proprietary BioREtain technology platform. With expanding clinical validation and a focus on the multi-billion-dollar wound care market, BSEM is drawing attention as it scales hospital adoption.August 14 at 1:00 AM | Huge Alerts (Ad)AMPH Q2 Deep Dive: Portfolio Expansion and Pipeline Progress Drive ResultsAugust 11 at 9:37 AM | finance.yahoo.comPiper Sandler Cuts Amphastar Pharmaceuticals (NASDAQ:AMPH) Price Target to $20.00August 10, 2026 | americanbankingnews.comAmphastar Pharmaceuticals (NASDAQ:AMPH) Price Target Raised to $20.00August 10, 2026 | americanbankingnews.comSee More Amphastar Pharmaceuticals Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Amphastar Pharmaceuticals? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Amphastar Pharmaceuticals and other key companies, straight to your email. Email Address About Amphastar PharmaceuticalsAmphastar Pharmaceuticals (NASDAQ:AMPH) is a specialty pharmaceutical company headquartered in Rancho Cucamonga, California. Founded in 2004, Amphastar focuses on the development, manufacturing and commercialization of injectable and inhalation products. The company’s manufacturing facilities in California produce both generic and proprietary formulations designed to address urgent and chronic medical conditions. Amphastar’s portfolio includes a range of injectable generics such as epinephrine, naloxone and lidocaine, serving hospital, emergency medical and retail pharmacy channels. The company also markets proprietary respiratory therapies, including over-the-counter inhaled products. Amphastar leverages its in-house drug delivery technologies to support both its own product lines and contract manufacturing services for third-party partners. In addition to marketed products, Amphastar maintains a pipeline of new drug candidates and device enhancements, including next-generation inhalation systems and branded formulations. The company’s research and development efforts are centered on improving patient access to essential medications while advancing delivery platforms that enhance convenience and dosing precision. Amphastar primarily serves the U.S. pharmaceutical market, with select international distribution partnerships. Leadership is anchored by Chief Executive Officer Enno Walther, who oversees strategic growth initiatives and manufacturing operations. The company is governed by a board of directors with experience in pharmaceutical development, regulatory affairs and commercial strategy.View Amphastar Pharmaceuticals ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Latest Articles Cerebras Sells Off After Earnings: Is This a Market Disconnection?Nebius Just Exploded 34% on Blowout Earnings—Is It Time to Buy?Sandisk’s Margins Look Like Software. 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PresentationSkip to Participants Operator00:00:00Greetings. Welcome to the Amphastar Pharmaceuticals Inc. second 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 this conference, please press star zero on your telephone keypad. 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 section entitled Forward-Looking Statements in the press release issued today and the presentation on the company's website. Please refer to our SEC filings, which can be found on the company's website and the SEC's website, for a discussion of numerous factors that may impact our future performance. Operator00:00:51We will also discuss certain non-GAAP measures. Important information on our use of these measures and reconciliations to U.S. 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 DischnerSVP of Human Resources and Corporate Communications at Amphastar Pharmaceuticals00:01:24Thank you, Paul. Good afternoon, everyone. Thank you for joining Amphastar's second quarter 2026 earnings call. Earlier today, we reported the financial results for the second quarter ended June thirtieth, 2026, which are available on the Investors page of our website. The second quarter was marked by strong execution across each of our strategic growth pillars. We observed continued demand across our commercial portfolio. We expanded our manufacturing capabilities and advanced both our development pipeline and regulatory programs. As a result, we generated improved financial performance during the second quarter. Revenue increased to approximately $184 million, reflecting both sequential and year-over-year growth. Profitability also improved significantly from the first quarter, driven by increased revenue, margin expansion, and enhanced operating performance. Despite a dynamic operating environment, our strategic priorities have remained consistent. Dan DischnerSVP of Human Resources and Corporate Communications at Amphastar Pharmaceuticals00:02:27We continue to focus on building a diversified pharmaceutical company supported by three complementary growth pillars. First, expanding and optimizing our branded and differentiated commercial portfolio. Second, advancing our pipeline of complex generic and biosimilar products. Third, progressing our proprietary development programs that have the potential to create significant long-term value. We believe this diversified business model provides multiple avenues for growth, enhances resilience, and reduces our dependence on any single product, market, or revenue stream. Turning to the first pillar of our growth strategy, expanding and optimizing our branded and differentiated commercial portfolio. We continued to make meaningful progress during the second quarter. Products such as BAQSIMI and Primatene MIST remain central to our long-term strategy and continue to demonstrate strong consumer demand. BAQSIMI remained an important contributor to our business. Dan DischnerSVP of Human Resources and Corporate Communications at Amphastar Pharmaceuticals00:03:33Total prescriptions increased approximately 17% compared with the second quarter of last year, demonstrating continued growth in patient demand. BAQSIMI's net sales were approximately $45.5 million, a decrease of approximately 3% compared to the prior year quarter. The difference primarily reflects pricing, rebates, and commercial dynamics. Importantly, strong prescription growth continues to reinforce our confidence in the long-term strength of the franchise. In June, we also completed the third contract year following our acquisition of BAQSIMI from Eli Lilly. During the contract year, BAQSIMI generated $178.3 million in net sales, exceeding the $175 million threshold and triggering our first milestone payment to Lilly. Achieving this milestone reflects the continued strength of the franchise and the successful execution of our commercial strategy since acquiring the product. Dan DischnerSVP of Human Resources and Corporate Communications at Amphastar Pharmaceuticals00:04:35Our focus remains on expanding patient access, supporting continued prescription growth, and managing the business with disciplined commercial execution to maximize long-term value. Primatene MIST continued to demonstrate strong consumer demand during the quarter. Each in-store sales increased compared with both the prior year quarter and the first quarter of 2026, reflecting continued brand strength and market penetration. While reported net sales declined, the decrease was largely attributable to consumer ordering patterns and the timing of shipments associated with pricing discussions with certain retailers. We believe these were temporary channel-related effects rather than a change in consumer demand. Retail performance remained healthy throughout the quarter, reinforcing our confidence in the Primatene MIST franchise and the effectiveness of our marketing investments and commercial execution. At the same time, performance across our broader portfolio reflected the competitive dynamics that are characteristic of the generic pharmaceutical market. Dan DischnerSVP of Human Resources and Corporate Communications at Amphastar Pharmaceuticals00:05:44Glucagon sales declined compared with the prior year as a result of increased competition. We believe this underscores the importance of continuing to diversify our commercial portfolio and advance new products, which can create multiple sources of growth and enhance the resilience of our business over the long term. Furthermore, during the quarter, our manufacturing facility, Armstrong, benefited from the successful launch of our ipratropium bromide product in April. The launch further demonstrates our ability to advance technically complex generic products from development through regulatory approval and into commercial production, reinforcing a core capability that differentiates our platform. Based on early demand and the current competitive landscape, we believe ipratropium bromide represents an attractive long-term opportunity for Amphastar. We continue to invest strategically across our U.S. manufacturing network to strengthen quality and efficiency, expand automation and capacity, and prepare for upcoming pipeline products. Dan DischnerSVP of Human Resources and Corporate Communications at Amphastar Pharmaceuticals00:06:50As policymakers and consumers place greater emphasis on domestic pharmaceutical manufacturing and supply chain resilience, we believe our U.S.-based manufacturing footprint, combined with our vertically integrated development and commercialization capabilities, represents a meaningful competitive advantage. These investments not only support our current commercial portfolio, but also provide a strong foundation for future product launches and sustainable long-term growth. IMS, one of our subsidiaries, recently received an FDA warning letter related to the FDA inspection conducted in December 2025. Since the inspection, IMS has continued implementing corrective actions. We have responded to the FDA in a timely manner regarding our remediation plan and continue to work closely with the agency to address the items identified in the warning letter. The warning letter does not require IMS to stop manufacturing or distributing its products. Dan DischnerSVP of Human Resources and Corporate Communications at Amphastar Pharmaceuticals00:07:50While the remediation effort will require additional resources, at this time, we do not currently anticipate a material adverse effect on Amphastar's overall business operations, commercial portfolio, development pipeline, or sales. We remain committed to addressing the FDA's observations thoroughly and sustainably. Quality remains a fundamental responsibility throughout Amphastar, and we will continue strengthening the overall effectiveness of our quality systems. Turning to our third pillar of growth strategy, advancing our development pipeline, we continue to achieve important regulatory and clinical milestones during the second quarter. For our insulin aspart biosimilar and interchangeable program, we continue preparing for potential commercialization in 2027, subject to regulatory approval. We have also made meaningful progress with our proprietary pipeline. During the second quarter, we initiated the phase I clinical program for AMP-101, our epinephrine nasal product. For AMP-109, our targeted oncology program, non-clinical studies are underway. Dan DischnerSVP of Human Resources and Corporate Communications at Amphastar Pharmaceuticals00:09:02During the quarter, we received constructive feedback from the FDA and are continuing preparation for regulatory interactions in the near future and an anticipated IND submission. Development activities are ongoing for AMP-110, our synthetic human corticotropin program, and AMP-107, our eye drop program for wet age-related macular degeneration and diabetic macular edema, as we look to advance both towards a future IND submission. While these programs remain in early stages of development, we believe they represent meaningful long-term opportunities. Leveraging our scientific, regulatory, and manufacturing capabilities, these programs have the potential to expand our presence into larger proprietary markets and create additional drivers of future growth and value creation. 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 second quarter. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:10:06Thank you, Dan, and good afternoon, everyone. In my comments today, I will discuss the second quarter results and then update some of our assumptions for 2026. Revenues for the second quarter increased 5% to $183.9 million from $174.4 million in the previous year's period. Ipratropium Bromide Inhalation, which we launched in April, led to growth with strong sales of $8.4 million. BAQSIMI revenues decreased 3% to $45.5 million, compared to $46.7 million in the prior year. An increase in units sold, contributing $6.9 million in sales, was driven by our continued marketing efforts. Lower average selling prices negatively impacted sales by approximately $8.1 million, primarily as a result of higher rebates and higher 340B pharmacy discounts, some of which may have been duplicated. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:11:05In May, in response to these pricing dynamics we had seen over the past few quarters, we engaged a third party to support data-driven identification, validation, and resolution of potential 340B duplicate discounts, which led to a smaller impact than we saw in the first quarter. Primatene sales were $21 million in the second quarter, down 8% from $22.9 million in the second quarter of last year due to the timing of customer purchases. Epinephrine sales were relatively flat, as weakness in the vial product was offset by increased demand for our pre-filled syringe product. Glucagon sales declined 42% to $11.9 million from $20.6 million due to increased competition. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:11:51Sales of other products increased 25% to $66.2 million from $53.1 million, primarily due to recently launched products, including iron sucrose, with sales of $3.5 million, and teriparatide, with sales of $4.5 million, which we launched in August 2025 and December 2025, respectively. An increase in albuterol sales of $2.4 million, which we launched in 2024, also contributed to the increase. Additionally, an increase in phytonadione and sodium bicarbonate sales, driven by higher demand resulting from supplier shortages, and an increase in sales of API from our AMP subsidiary, had a positive impact on sales. Cost of revenues increased 3% to $90.4 million from $87.9 million. Gross margins increased to 51% of revenues in the second quarter of 2026 compared to 50% in the previous year period. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:12:53The primary drivers of the change were sales of recently launched products with higher margins such as ipratropium bromide, teriparatide, and iron sucrose. This trend was partially offset by a lower average selling price for BAQSIMI, glucagon, and epinephrine multidose vials. Additionally, we had increased manufacturing costs at our Amphastar facility. Selling, distribution, and marketing expenses increased 30% to $13.3 million from $10.2 million, primarily due to an increase in marketing efforts for BAQSIMI and higher freight expenses. General and administrative spending increased 30% to $18.2 million from $14 million, driven by higher legal expenses, salary and personnel-related expenses, as well as expenses related to the implementation of a new ERP system. Research and development expenditures increased 10% to $22.2 million from $20.1 million, primarily due to an increase in clinical trial expense, largely for our insulin pipeline. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:13:56Our non-operating expense of $1.2 million during the period compares to a non-operating expense of $2.8 million in the prior year period, primarily due to foreign currency fluctuations and mark-to-market adjustments related to our interest rate swap contract during the quarter. Net income decreased slightly to $30.3 million, but increased on a per-share basis to $0.67 in the second quarter from $31 million, or $0.64 per share in the second quarter of 2025. Adjusted net income was relatively flat at $40.8 million, but increased on a per-share basis to $0.91 in the second quarter compared to an adjusted net income of $40.9 million or $0.85 per share in the second quarter of last year. Adjusted earnings excludes amortization, equity compensation, and one-time events. In the second quarter, we had cash flow from operations of approximately $51.3 million. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:14:53During the quarter, we accelerated our share repurchase program and bought back approximately $45 million worth of shares. Separately, in June, we achieved the first annual BAQSIMI net sales milestone under our asset purchase agreement with Eli Lilly, which triggers a $100 million payment due in the third quarter of 2026. Before I turn the call back over to Dan, I would like to update some of our guidance for 2026. Due to remediation efforts at our IMS facility, we expect expenses there will increase by $2 million to $3 million per quarter for the next several quarters. Capital expenditures will also increase at this facility, but there will be no change to our previously communicated capital expenditure profile as we redirect spending from our Amphastar facility to our IMS facility. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:15:45We also expect a slight slowing of sales from IMS as we concentrate on addressing corrective actions, thus improving the quality and manufacturing systems. Importantly, even with this revised outlook, we maintain our overall corporate sales guidance of mid-single digit to high single-digit sales growth, reflecting the strength of our broader portfolio. I will now turn the call back over to Dan. Dan DischnerSVP of Human Resources and Corporate Communications at Amphastar Pharmaceuticals00:16:09Thank you, Bill. Looking ahead, our priorities remain clear. We are focused on supporting continued growth across our commercial portfolio, expanding our U.S. manufacturing capabilities, completing the IMS remediation activities, advancing our near-term regulatory programs, and continuing disciplined investment in our proprietary pipeline. We believe the second quarter highlighted the strength and resilience of Amphastar's diversified business model. Dan DischnerSVP of Human Resources and Corporate Communications at Amphastar Pharmaceuticals00:16:37Faced with a dynamic operating environment, we delivered improved financial performance, generated continued demand across our key commercial brands, and achieved important regulatory and development milestones. These results reflect the benefits of our diversified growth strategy and the balanced foundation we have built across our commercial portfolio, development pipeline, and manufacturing platform. We also believe Amphastar is well-positioned for the evolving pharmaceutical landscape. Our diversified product portfolio, our U.S.-based finished product manufacturing footprint, vertically integrated capabilities, and growing development pipeline provide multiple avenues of growth and support long-term value creation. Dan DischnerSVP of Human Resources and Corporate Communications at Amphastar Pharmaceuticals00:17:21With that, we will now take your questions. Paul? Operator00:17:27Thank you. We'll now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we call for questions. Thank you. Our first question is from Ekaterina Knyazkova with JPMorgan. Ekaterina KnyazkovaEquity Research Associate at JPMorgan00:18:02Thanks so much. First question is just on operating costs. Can you just elaborate a bit on how we should think about spend from here and what both R&D and SG&A could look like over the next several quarters? A related question just on adjusted gross margins. Seems like there's been quite a bit of volatility in that number over the past few quarters. Just what's been driving that, and what's a good baseline to use for gross margins in the second half of the year? Thanks. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:18:24Yes. There's a couple things driving the decrease in the first quarter. The primary thing was the BAQSIMI double dip counting that we saw there. That had a pretty negative impact. We had some better impacts in the second quarter as we began some procedures to mitigate that and hired an independent party that's going to help reduce that double discount. The second thing in the second quarter was that we had the launch of Ipratropium Bromide HFA, which is a higher margin product, that really helped out a lot. On a going forward basis, I would expect to see the coming quarter similar to this quarter, because remember, we'll have higher BAQSIMI sales next quarter, those higher sales should offset some of the costs that we're expecting at IMS. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:19:13Additionally, on the G&A and selling expense, I think the second quarter is also a good comp for those. The R&D expense, we do expect that to tick up a little bit as a percentage of sales on a going forward basis. Ekaterina KnyazkovaEquity Research Associate at JPMorgan00:19:32Thanks. Operator00:19:36Our next question is from Dennis Ding with Jefferies. Dennis DingSVP and Analyst at Jefferies00:19:41Hi. Thanks for taking the questions. I have two questions. Number one, remind us what's going on with the IMS facility that got the warning letter. If I recall, you guys probably responded to it in late July. Remind us the revenue exposure here again from this facility, what are the next steps from the FDA and when, and then would remediation plans require shutting down some of the production lines? That's question number one. Question number two, on BAQSIMI's 340B dynamic, I think you said 80% of that pricing pressure can ultimately go away. Can you reiterate that number on the call today, and how much of that 80% was recovered in Q2, and how much is left to recover in Q3? Thanks so much. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:20:30Okay. Let me start with the revenue. IMS makes, the sales are probably about a third of our overall corporate sales on a big picture. However, we are still shipping there. We don't expect to stop shipping there. We still are producing at the same rate that we've been. We have taken some quality steps which have slowed down some of the releases, some of the batches right now to make sure that they've gone through an extra quality review, so that's led to a small delay right now for that. I'll turn it over to Tony for some of the other next steps that we have going on there. Tony MarrsEVP of Regulatory Affairs and Clinical Operations at Amphastar Pharmaceuticals00:21:12Yeah. As you mentioned, we did respond to the warning letter in late July. Essentially the way these are is you have an interaction where you update the FDA on a routine basis, generally every month or two, just to go over your plan and the program. We've hired a third-party independent consultant that has great experience in helping to work with these kind of projects. We'll continue to just work with them and if there are any remediation efforts, we'll work with them and keep the FDA in the loop with that. If there are any shutdowns, as you mentioned, which is definitely a possibility, we'll do those as needed. We routinely do those now. Whether it's a little bit longer or not remains to be depending on what they find during the remediation and during the assessments. Tony MarrsEVP of Regulatory Affairs and Clinical Operations at Amphastar Pharmaceuticals00:22:14We do routinely have those, unlikely at this point. We don't have any expectation that there'll be any of those, again, it sort of remains to be seen based on the assessments. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:22:28going back to the last question on BAQSIMI on the 340B. We just implemented that consultant, or that firm that helps us with this in May. We only covered two months, and I'll say not all of their actions took place right away. When we talked about reducing 80% of the double-dipping on the last call, I'd say that we probably are halfway there at this point. Dennis DingSVP and Analyst at Jefferies00:22:59Thank you. Operator00:23:03Our next question is from David Amsellem with Piper Sandler. Malcolm ArmourResearch Associate at Piper Sandler00:23:09Hi, this is Malcolm Armour for David. Thank you for taking our questions. First, with respect to BD, is your priority acquiring immediately accretive commercial products, or would you accept some development spending for a differentiated late-stage asset? That's number one. Number two, also with respect to BD, are you willing to establish a new commercial organization in a new vertical or will any potential targets need to leverage existing commercial infrastructure? Thank you. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:23:35Yeah. Good question. As far as the development goes, we have been looking at both development programs and things that would be immediately accretive or soon to be accretive, I'll say, things that are very late stage, essentially filed. Right now, because we in-licensed three products last year that are early stage, our real focus and what we prefer to look at are things that would be either immediately accretive or accretive to earnings within a year. That's the strong preference. However, we're looking at multiple things, and if we saw the right thing that was an early stage, we'd probably do that. I think the cost structure of those is very different. For example, when we took a look at the four products that we in-licensed last year, the upfront cost was $2 million each. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:24:29Much, much lower than a BAQSIMI or something else that's already on the market. As far as new commercial verticals, we would consider new commercial verticals, but they would probably be in the areas where we have either some kind of planned product, such as the in-license assets that are in oncology, ophthalmology, and immunology. Those are the three areas that we would consider new verticals, in addition to the endocrinology where we have BAQSIMI. I don't see us moving outside of those verticals. Malcolm ArmourResearch Associate at Piper Sandler00:25:07Thank you. Operator00:25:12Our next question is from Serge Belanger with Needham & Company. Analyst at Needham & Company00:25:19Hi, this is John on for Serge today. Thanks for taking our questions. Just a couple on your current product portfolio. The first being the generic Atrovent launch that came about in mid-April. I believe you've highlighted previously that you see this product capturing as much as 50%-80% of the market. Curious what the early stages of the launch have shown thus far and whether you've narrowed that market share goal at this time. Second, on glucagon, you highlighted that it's still seeing some competitive pressures. Although it increased a little bit in the second quarter over the first quarter, I'm curious if you think that this product is now at a stabilization period and could return to growth in the second half of the year. Thanks. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:26:11Yeah. Generic Atrovent, we've got a nice market share, and we are closing in on that goal range that we have put out there, but we're not quite there yet. We're really happy with where we are at this point, and that product launch has gone really well for us. As far as glucagon goes, we saw several new competitors come in over about an 18-month period, including all the way into late last year. Year-over-year, we haven't finished the decline. On a go-forward basis, that rate of decline, we think will diminish. The worst of that decline is over. However, we don't see this as becoming a growth product again. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:27:04In all likelihood, it's something where we're finding that we think that the portion of the market that's for diagnostic will grow slightly, but the portion that's for the anti-hypoglycemia will continue to decline somewhat. We don't see this as being a growth thing. It's going to decline. The decline is more muted than it's been over the last several quarters. Analyst at Needham & Company00:27:37Great. Thank you. Operator00:27:42Our next question is from Jason Gerberry with BofA Securities. Analyst at BofA Securities00:27:48Hi, this is Melanie on for Jason. Thanks for taking our question. Just on AMP-004, your insulin aspart. Based on current price levels and anticipated concessions, do you see the product gross margin being relative to corporate levels? Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:28:06Yes. This is something that we think will probably be at or slightly below the current corporate gross margin levels, given the competition that we see in those today. It is still being something where we have a fairly large sales potential for us. We think sales will be meaningful for us. Operator00:28:38Our next question is from Ben Burnett with Wells Fargo. Ken ShihAnalyst at Wells Fargo00:28:44Hi. Hello, this is Ken Shih on for Ben Burnett. Thanks for taking our questions. One question we have is that on the insulin aspart bioavailability study, recently it's shown up as completed on ClinicalTrials.gov. Is this something that you can touch on? What does the data look like? What is the path forward on this? Thank you. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:29:05Okay. Could you please repeat the question again? I think we were having a little hard time understanding. Ken ShihAnalyst at Wells Fargo00:29:12Oh, sorry. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:29:13Which product are you referring to? Ken ShihAnalyst at Wells Fargo00:29:17Yeah, sorry, let me repeat again. Yeah, it's the insulin aspart bioavailability study showing up recently on clinicalTrials.gov as completed. Is this something that you can touch on? Have you seen the data? What's the path forward in terms of resubmitting, et cetera? Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:29:38The question is about the trial. If you had seen on it's a bioequivalent PK type trial, and it's just measuring the AUC between the two products, the reference and the other one. I think that's what it is. What I'll say about that product is we're on schedule for that to have our commercial launch of the product next year in 2027. Ken ShihAnalyst at Wells Fargo00:30:13Thanks for the color. Bill PetersEVP and CFO at Amphastar Pharmaceuticals00:30:15Thanks. Operator00:30:19Thank you. There are no further questions at this time. I would like to hand the floor back over to management for any closing remarks. Dan DischnerSVP of Human Resources and Corporate Communications at Amphastar Pharmaceuticals00:30:26Thank you, Paul, and thank you all for the questions today. As highlighted in our remarks today, we remain focused on executing our long-term strategy, strengthening our commercial portfolio, advancing our pipeline, and continuing to invest in our U.S. manufacturing capabilities. Thank you for your continued interest in Amphastar. We appreciate your support and look forward to updating you on our progress next quarter. Operator00:30:54This concludes today's conference. You may disconnect your lines at this time. Thank you again for your participation.Read moreParticipantsExecutivesDan DischnerSVP of Human Resources and Corporate CommunicationsBill PetersEVP and CFOTony MarrsEVP of Regulatory Affairs and Clinical OperationsAnalystsEkaterina KnyazkovaEquity Research Associate at JPMorganDennis DingSVP and Analyst at JefferiesMalcolm ArmourResearch Associate at Piper SandlerAnalyst at Needham & CompanyAnalyst at BofA SecuritiesKen ShihAnalyst at Wells FargoPowered by