Q4 2025 Amphastar Pharmaceuticals Inc Call

February 26, 2026

Speaker #1: Greetings and welcome to the Amphastar Pharmaceuticals, Inc. fourth quarter earnings call . At this time , all participants are in a listen only mode .

Speaker #1: A question and answer session will follow the formal presentation . If anyone should require operator assistance during the conference , please press Star Zero on your telephone keypad .

Speaker #1: 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 .

Speaker #1: These statements are based solely on information that is now available to us . We encourage you to review the session entitled Forward looking Statements in the press release issued today and the presentation on the company's website Also , please refer to our SEC filings , which can be found on our website and the SEC's website for a discussion of numerous factors that may impact our future performance .

Operator: We encourage you to review the session 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 our website and the SEC's website for a discussion of numerous factors that may impact our future performance. 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.

Operator: We encourage you to review the session 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 our website and the SEC's website for a discussion of numerous factors that may impact our future performance. 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 Dolin, 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.

Speaker #1: 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 .

Speaker #1: Please note , this conference is being recorded Our speakers today are . Mr. . Bill Peters , CFO . Mr. Dan Dischner , Senior Vice President of Corporate Communications .

Speaker #1: And Mr. Tony Mars , 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 .

Speaker #2: Thank you . Paul . Good afternoon , everyone , and thank you for joining Amphastar . Fourth quarter 2020 Earnings call . 2025 was a pivotal year for the company , demonstrating the strength and balance of our business model with our continued focus on both commercial execution and scientific innovation Vaccine maintained its strong double digit growth trajectory , reinforcing the durability of our franchise , and continued execution .

Dan Dischner: Thank you, Paul. Good afternoon, everyone. Thank you for joining Amphastar's Q4 2025 earnings call. 2025 was a pivotal year for the company, demonstrating the strength and balance of our business model with our continued focus on both commercial execution and scientific innovation. Saxeny maintained its strong double-digit growth trajectory, reinforcing the durability of our franchise and continued execution. FDA approvals for iron sucrose and teriparatide highlighted our technical depth in complex generics. Just this week, we achieved another major regulatory milestone with the FDA approval of our Ipratropium Bromide HFA inhalation aerosol. Previously referenced as AMP-007, the FDA also confirmed that this product is eligible for 180 days of generic drug exclusivity as we were the first ANDA applicant with Paragraph IV certification.

Speaker #2: While FDA approvals for iron , sucrose and teriparatide highlighted our technical depth in complex generics . And just this week , we achieved another major regulatory milestone with the FDA approval of our ipatropium bromide HFA inhalation aerosol , previously referenced as AMP 007 .

Speaker #2: The FDA also confirmed that this product is eligible for 180 days of generic drug exclusivity . As we were the first Anda applicant with paragraph four certification , this approval reinforces the strength of our integrated R&D and manufacturing model and represents a meaningful addition to our respiratory portfolio .

Dan Dischner: This approval reinforces the strength of our integrated R&D and manufacturing model and represents a meaningful addition to our respiratory portfolio. We expect to launch this product commercially early in Q2 2026, positioning it as a significant near-term growth driver. Across the pipeline, we advanced and expanded our proprietary portfolio with the addition of three novel peptides in oncology and ophthalmology and a fully synthetic corticotropin program in immunology. These additions support our transition towards a portfolio increasingly anchored in high-value proprietary and biosimilar assets. On the commercial side, we remain attentive to the competitive pressures in certain legacy products and continue to prioritize resources towards our strongest growth opportunities. Our performance this year was driven by three core pillars: resilient commercial momentum, strategic pipeline progress, and disciplined operational execution supported throughout our US-based manufacturing advantage.

Speaker #2: We expect to launch this product commercially early in the second quarter of 2026 , positioning it as a significant near-term growth driver across the pipeline .

Speaker #2: We advanced and expanded our proprietary portfolio with the addition of three novel peptides in oncology and ophthalmology , and a fully synthetic corticotropin program in immunology These additions support our transition towards a portfolio increasingly anchored in high value , proprietary and biosimilar assets On the commercial side , we remain attentive to the competitive pressures in certain legacy products and continue to prioritize resources towards our strongest growth opportunities , our performance this year was driven by three core pillars resilient , commercial momentum , strategic pipeline progress , and disciplined operational execution .

Speaker #2: Supported throughout our US based manufacturing advantage . For the full year , net revenues were 719.9 million . Vaccine remained a key contributor , generating 185.4 million in revenue , up 12% year over year , driven by higher US unit volumes and the successful transition to direct global .

Dan Dischner: For the full year, net revenues were $719.9 million. BAQSIMI remained a key contributor, generating $185.4 million in revenue, up 12% year-over-year, driven by higher US unit volumes and the successful transition to direct global distribution. Primatene MIST also performed well, with sales rising 7% to $108.7 million, supported by strong consumer demand and continued marketing investments. We saw additional contributions from newer and expanding products, including $4.4 million from iron sucrose following its August launch, and a strong growth in albuterol driven by market demand. These gains helped offset competitive pressures in epinephrine and glucagon. Full-year revenue declined modestly by 2%, reflecting greater than expected headwinds in legacy products.

Speaker #2: Primatene Mist also performed well , with sales rising 7% to 108.7 million , supported by strong consumer demand , and continued marketing investments we saw additional contributions from newer and expanding products , including 4.4 million from iron , sucrose .

Speaker #2: Following its August launch and a strong growth in albuterol driven by market demand . These gains helped offset competitive pressures in epinephrine and glucagon Full year revenue declined modestly by 2% , reflecting greater than expected headwinds in legacy products Even so , we maintained strong operational discipline , tightening expenses , prioritizing long term investments and mitigating margin pressures in areas facing pricing challenges , operating cash flow totaled 156.1 million , demonstrating the resilience of our model and our ability to continue investing in strategic priorities on the pipeline side , we achieved several major regulatory milestones with approvals for iron , sucrose , teriparatide , and most recently Ipratropium bromide HFA .

Dan Dischner: Even so, we maintained strong operational discipline, tightening expenses, prioritizing long-term investments, and mitigating margin pressures in areas facing pricing challenges. Operating cash flow totaled $156.1 million, demonstrating the resilience of our model and our ability to continue investing in strategic priorities. On the pipeline side, we achieved several major re-regulatory milestones with approvals for iron sucrose, teriparatide, and most recently, Ipratropium Bromide HFA. These achievements broadened our capabilities across complex injectables and inhalation products. We also expanded our proprietary pipeline with high-value assets, including AMP-105, AMP-109, AMP-110, and AMP-107, programs that collectively open more than $60 billion in addressable market opportunity and strengthen the long-term foundation of our portfolio. We also continue to advance several high-impact programs that remain on track for near-term launches.

Speaker #2: These achievements broadened our capabilities across complex injectables and inhalation products . We also expanded our proprietary pipeline with high value assets , including AMP 105 , AMP , 109 , AMP , 110 and AMP 107 .

Speaker #2: Programs that collectively open more than 60 billion in addressable market opportunity and strengthen the long term foundation of our portfolio . We also continue to advance several high impact programs that remain on track for near-term launches .

Speaker #2: Our insulin Aspart Bla for AMP 004 and our GLP one Anda for AMP 018 are moving steadily through regulatory proceedings with anticipated commercialization for each expected in 2027 .

Dan Dischner: Our insulin aspart BLA for AMP-004 and our GLP-1 ANDA for AMP-018 are moving steadily through regulatory proceedings with anticipated commercialization for each expected in 2027. Together, these programs represent meaningful near and midterm value drivers as we expand our presence across complex formulations and high-demand therapeutics. To support this expanding pipeline, our US manufacturing investment in Rancho Cucamonga remains a critical pillar of our long-term strategy. The expansion will quadruple production capacity at the site, significantly enhancing scalability and improving supply reliability. The upgraded footprint positions us to meet future demand as our proprietary programs and complex generics advance towards commercialization, ensuring we can execute with the speed and consistency required in these high-growth markets.

Speaker #2: Together , these programs represent meaningful near and mid-term value drivers as we expand our presence across complex formulations and high demand therapeutics . To support this expanding pipeline .

Speaker #2: Our US manufacturing investment in Rancho Cucamonga remains a critical pillar of our long term strategy . The expansion will production capacity at the site significantly enhancing scalability and improving supply reliability .

Speaker #2: The upgraded footprint positions us to meet future demand as our proprietary programs and complex generics advance towards commercialization , ensuring we could execute with the speed and consistency required in these high growth I will now turn the call over to Bill Peters , our CFO and Executive Vice President of Finance .

Dan Dischner: I will now turn the call over to Bill Peters, our CFO and Executive Vice President of Finance, for more detailed financial review of the Q4 and full year.

Speaker #2: For more detailed financial review of the fourth quarter and full year Thank you , Dan , and good afternoon , everyone , and my comments today I will discuss the fourth quarter results and then our assumptions for 2026 .

Bill Peters: Thank you, Dan, and good afternoon, everyone. In my comments today, I will discuss the Q4 results and then our assumptions for 2026. Sales for the Q4 of 2025 decreased 2% to $183.1 million from $186.5 million in the previous year's period. BAQSIMI sales grew 12% to $46.7 million from $41.8 million in the prior year period as we continue our sales and marketing efforts in the United States. Primatene MIST sales dropped 3% to $27.9 million from $28.9 million in the prior year period.

Speaker #2: Sales for the fourth quarter of 2025 decreased 2% to $183.1 million , from $186.5 million in the previous year's period Vaccine sales grew 12% to $46.7 million , from $41.8 million in the prior year period .

Speaker #2: As we continue our sales and marketing efforts in the United States , Primatene mist sales dropped 3% to 27.9 million from $28.9 million in the prior year period Glucagon sales declined 45% to $14.1 million from $25.6 million in the prior year period , due to increased competition , as well as a market move toward ready to use products such as vaccine Epinephrine sales declined 9% to $17.1 million from $18.7 million in the previous year's period , due to increased competition for epinephrine multi-dose vial product .

Bill Peters: Glucagon sales declined 45% to $14.1 million from $25.6 million in the prior year period due to increased competition as well as a market move toward ready-to-use products such as BAQSIMI. Epinephrine sales declined 9% to $17.1 million from $18.7 million in the previous year's period due to increased competition for our epinephrine multi-dose vial product. This decrease was partially offset by an increase in unit volumes for our epinephrine prefilled syringe, driven by increased demand caused by shortages from other suppliers during the quarter. Other pharmaceutical product revenue grew 8% to $62.4 million from $57.5 million in the previous year's period, primarily due to increased sales of albuterol and iron sucrose, which we launched in August 2024 and August 2025 respectively.

Speaker #2: This decrease was partially offset by an increase in unit volumes for our epinephrine prefilled syringe , driven by increased demand caused by shortages from other suppliers during the quarter Other pharmaceutical product revenue grew 8% to $62.4 million , from $57.5 million in the previous year's period , primarily due to increased sales of albuterol and iron sucrose , which we launched in August 2024 and August 2025 , respectively Gross margins remained flat at 47% of revenues , as we saw increased sales of vaccine and iron .

Bill Peters: Gross margins remained flat at 47% of revenues as we saw increased sales of BAQSIMI and iron sucrose. This is offset by a decrease in pricing of glucagon and our epinephrine multi-dose vial products. Selling, distribution and marketing expenses were essentially unchanged at $10.3 million in Q4 2025 compared to $10.4 million in the previous year's period. General and administrative expenses increased 27% to $16.5 million compared to $12.9 million in the prior year, primarily due to increased legal expenses and expenses related to the implementation of a new ERP system. Research and development expenditures increased 29% in the quarter to $23.3 million from $18.1 million in the comparable quarter of 2024, primarily due to increased spending on our insulin and proprietary pipelines.

Speaker #2: Sucrose . This was offset by a decrease in pricing of glucagon and epinephrine . Multi-dose vial product selling , distribution and marketing expenses were essentially unchanged at $10.3 million in the fourth quarter of 2025 , compared to $10.4 million in the previous year's period General and administrative expenses increased 27% to $16.5 million , compared to $12.9 million in the prior year , primarily due to increased legal expenses and expenses related to the implementation of a new ERP system .

Speaker #2: Research and development expenditures increased 29% in the quarter to $23.3 million, from $18.1 million in the comparable quarter of 2024, primarily due to increased spending on our insulin and proprietary pipeline.

Speaker #2: Nonoperating expenses in the fourth quarter of 2025 were $3.7 million , compared to $1.2 million in the prior year period , primarily as a result of foreign currency fluctuations .

Bill Peters: Non-operating expenses in Q4 2025 were $3.7 million compared to $1.2 million in the prior year period, primarily as a result of foreign currency fluctuations, mark-to-market adjustments related to our interest rate swap contract. We reported net income of $24.4 million, or $0.51 per share, compared to the previous year's Q4 net income of $38 million, or $0.74 per share. Adjusted net income was $34.2 million, or $0.73 per share, compared to an adjusted net income of $47.2 million, or $0.92 per share in Q4 of the previous year. Adjusted earnings exclude amortization, equity compensation, and one-time events.

Speaker #2: Mark to market adjustments related to our interest rate swap contracts We reported net income of $24.4 million , or $0.51 per share , compared to the previous year's fourth quarter .

Speaker #2: Net income of $38 million , or $0.74 per share . Adjusted net income was $34.2 million , or $0.73 per share , compared to an adjusted net income of $47.2 million , or $0.92 per share , in the fourth quarter of the previous year .

Speaker #2: Adjusted earnings exclude amortization , equity compensation and one time events in the fourth quarter , we had cash flows provided by operations of approximately $32.9 million , and for the full year , cash flow from operations were $156.1 million .

Bill Peters: In Q4, we had cash flows provided by operations of approximately $32.9 million. For the full year, cash flow from operations were $156.1 million. As we look ahead to 2026, we are basing our outlook on several key financial assumptions. For BAQSIMI, we expect mid-single-digit unit growth in the US, partially offset by a planned reduction in international volume as we exit a handful of unprofitable markets later in the year. We do not expect to take any price increases in 2026 as our primary focus is on unit growth. For Primatene Mist, we expect unit growth in the mid-to-high single digits this year, we plan to take a 5% increase on price in Q2.

Speaker #2: As we look ahead to 2026 , we are basing our outlook on several key financial assumptions for vaccine . We expect mid-single digit unit growth in the US , partially offset by a planned reduction in international volume as we exit a handful of unprofitable markets later in the year .

Speaker #2: We do not expect to take any price increases in 2026 as our primary focus is on unit growth . For Primatene mist , we expect unit growth in the mid to high single digits this year , and we don't plan and we plan to take a 5% increase in price in the second quarter .

Speaker #2: We expect the largest driver of growth will be the launch of ipratropium with a planned launch in early the second quarter . Our third metered dose inhalation product is poised to be a meaningful contributor as sales ramp up .

Bill Peters: We expect the largest driver of growth will be the launch of ipratropium bromide. With a planned launch in early Q2, our third metered dose inhalation product is poised to be a meaningful contributor as sales ramp up. We also expect increased contributions from third-party API sales from our ANP subsidiary. Offsetting these growth trends will be expected sales declines due to increased competition for glucagon, and to a lesser extent, epinephrine and Phytonadione. Overall, we expect these dynamics to drive consolidated revenue growth in the mid to high single digit range for 2026. We expect gross margins to be lower, primarily driven by continued pricing pressure on glucagon, epinephrine, and Phytonadione, which are high margin products. In addition, we are seeing higher input costs, including labor and supplier-related increases, which will further impact margins.

Speaker #2: We also expect increased contributions from third party API sales from our AMP subsidiary . Offsetting these growth trends will be expected . Sales declines due to increased competition for glucagon and to a lesser extent , epinephrine and phytonadione Overall , we expect these dynamics to drive consolidated revenue growth in the mid to high single digit range for 2026 .

Speaker #2: We expect gross margins to be lower , primarily driven by continued pricing pressure on glucagon , epinephrine , and phytonadione , which are high margin products .

Speaker #2: In addition , we are seeing higher input costs , including labor and supplier related increases , which will further impact margins . Our selling and marketing expense will increase slightly as a percentage of sales due to increased sales and marketing efforts for both vaccine and myth .

Bill Peters: Our selling and marketing expense will increase slightly as a percentage of sales due to increased sales and marketing efforts for both BAQSIMI and Primatene MIST. General and administrative spending will be flat to up as a percentage of sales due to one-time spending associated with the implementations of our new ERP system. Turning to research and development, we plan to ramp up spending on clinical trials and purchases of materials and supplies for inhalation and proprietary pipeline products. We also anticipate a significant increase in capital spending from the expansion project at our Rancho Cucamonga facility, which we announced last year. Spending on this major project was slower than we anticipated in 2025, but will ramp up more significantly in 2026. We plan to finance this expansion with cash flow from operations.

Speaker #2: General and administrative spending will be flat to up as a percentage of sales due to one time spending associated with implementations of our new ERP system Turning to research and development , we plan to ramp up spending on clinical trials and purchases of materials and supplies for inhalation and proprietary pipeline products .

Speaker #2: We also anticipate a significant increase in capital spending from the expansion project at our Rancho Cucamonga facility , which we announced last year Spending on this major project is slower than we anticipated in 2025 , but will ramp up more significantly in 2026 .

Speaker #2: We plan to finance this expansion with cash flow from operations as of today , we have over $300 million in cash and short term investments on our hands , and we plan to utilize a portion of our strong cash position to continue our stock buyback program Additionally , we continue to look for business development opportunities which fit Amphastar strategy .

Bill Peters: As of today, we have over $300 million in cash and short-term investments on our hands, and we plan to utilize a portion of our strong cash position to continue our stock buyback programs. Additionally, we continue to look for business development opportunities which fit Amphastar's strategy. I will now turn the call back over to Dan.

Speaker #2: I will now turn the call back over to Dan . Thank you . Bill In summary , 2025 was a year of meaningful progress and disciplined execution .

Dan Dischner: Thank you, Bill. In summary, 2025 was a year of meaningful progress and disciplined execution. We strengthened our commercial foundation with resilient performance from BAQSIMI and Primatene MIST, advanced our regulatory pipeline with FDA approvals of iron sucrose, teriparatide, and most recently, Ipratropium Bromide HFA inhalation aerosol, and made significant progress across our AMP-004 and AMP-018 near-term commercial product candidates. We also expanded our proprietary pipeline portfolio into high-growth therapeutic areas through the addition of novel product candidates in oncology, ophthalmology, and immunology. These achievements reinforce the depth of our scientific capabilities, the strategic value of our US manufacturing footprint, and our commitment to delivering high-quality therapies that improve patient access and outcomes. The momentum we've built positions Amphastar for significant long-term value creation through focused execution, innovation, and a robust pipeline designed to support sustainable growth. With that, we'll take your questions. Paul?

Speaker #2: We strengthen our commercial foundation with resilient performance from vaccine and primatene mist advanced our regulatory pipeline with FDA approvals of iron , sucrose , teriparatide and most recently .

Speaker #2: Ipatropium bromide HFA inhalation and made significant progress across our AMP . 004 and AMP 018 near-term commercial product candidates . We also expanded our proprietary pipeline portfolio into high growth therapeutic areas through the addition of novel product candidates in oncology , ophthalmology , and immunology .

Speaker #2: These achievements reinforce the depth of our scientific capabilities . The strategic value of our US manufacturing footprint , and our commitment to delivering high quality therapies that improve patient access and outcomes .

Speaker #2: The momentum we've built positions and for significant long term value creation through focused execution , innovation and a robust pipeline designed to support sustainable growth .

Speaker #2: With that , we'll take your questions Paul

Speaker #1: Thank 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 .

Operator: Thank 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 to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys. One moment please while we poll for questions. Thank you. Our first question is from Dennis Ding with Jefferies. Dennis, is your line on mute? Our next question is from Ekaterina Knyazkova with JPMorgan.

Speaker #1: A confirmation tone will indicate your line is in the question queue . You may press star two to remove your question from the queue .

Speaker #1: For participants using speaker equipment , and may be necessary to pick up the handset before pressing the star keys . One moment please , while we pull for questions Thank you .

Speaker #1: Our first question is from Dennis Ding with Jefferies Dennis , is your line on mute Our next question is from Ekaterina makarova with J.P.

Speaker #1: Morgan .

Speaker #3: Thank you so much . So first question is just on amp 110 . The corticotrophin asset . Just have you had any conversations with with the FDA on just what the development path could look like ?

Ekaterina Knyazkova: Thank you so much. First question is just on AMP-110, the corticotrophin asset. Just have you had any conversations with the FDA on just what the development path could look like? If there's anything you can share on that would be helpful. Second question is just on business development, just latest thoughts on appetite and priorities, just what kind of assets are you most interested in and how big of a priority is BD for you guys in 2026? Thank you.

Speaker #3: And if there's anything you can share on that , that would be helpful . And then second question is just on business development .

Speaker #3: Just latest thoughts on appetite and priorities . Just what kind of assets are they most interested in and how big of a priority is BD for you guys in 2026 ?

Speaker #3: Thank you .

Speaker #2: Thank you . I'll take the first .

Dan Dischner: Thank you. I'll take the first question for AMP-110. We have not engaged the FDA with conversation on that. We're internally still having the discussion and putting our program on paper. We'll be doing that in the relative near future.

Speaker #4: Question for 110 . We have not engaged the FDA with conversation on that . We're internally still having the discussion and putting our program on paper .

Speaker #4: We'll be doing that in the relatively near future

Speaker #2: And the second one for business development , our focus will be on areas where we either have a presence or planned presence . And that would include endocrinology .

Bill Peters: The second one for business development. Our focus will be on areas where we either have a presence or a planned presence, and that would include endocrinology because of our vaccinia product, and also the oncology, ophthalmology, and immunology spaces. Those are the areas where we have early-stage proprietary pipeline products.

Speaker #2: Because of a vaccine product . And also the oncology , ophthalmology and immune immunology spaces . And some of the areas where we have early stage proprietary pipeline products

Speaker #3: Thank you

Ekaterina Knyazkova: Thank you.

Speaker #1: Our next question is from Serge Belanger with Needham and Company

Operator: Our next question is from Serge Belanger with Needham & Company.

Speaker #5: Hi . Good afternoon . First question around back semi expectations for 2026 . Phil , I think you mentioned you expect mid-single digit growth on units .

Serge Belanger: Hi, good afternoon. First question around BAQSIMI expectations for 2026. Bill, I think you mentioned you expect mid-single-digit growth on units, but to be offset by some discontinuation of international sales. Just curious what the level of those international sales are and what that means if you expect growth from the franchise at all for the year. The second question around AMP-007. You know, just how big of an opportunity is this? I guess, have you gotten any news whether there's an authorized generic coming on the market and whether you think the Atrovent market is now stabilized after a significant step down in 2025 from 2024? Thanks.

Speaker #5: But to be offset by some discontinuation of international sales . Just curious what the level of those international sales are and what that means .

Speaker #5: If you expect growth from the franchise at all for for the year ? And then the second question around AMP 007 , you know , just how big of an opportunity is this , I guess , have you gotten any news whether there's an authorized generic coming on the market and whether you think the the atrovent market is now stabilized after a significant step down from in 2025 , from 2024 , thanks .

Speaker #2: Yeah . So vaccine , we do expect to see that mid single digit increase in units in the United States . And the international decline will come in the second half of the year .

Bill Peters: Yeah, BAQSIMI, we do expect to see that mid single-digit increase in units in the United States. The international decline will come in the second half of the year. We had a three-year commitment to keep marketing the product in all countries where Lilly was selling the product, and that commitment is up in July. At that time, we're likely to discontinue from a handful of countries. There are several countries where either the regulatory requirements are very hard and expensive, or their sales are just very minimal. Those are the two things that we're looking at. That will offset some of the price, some of the growth in the US.

Speaker #2: We had a three year commitment to keep marketing the product in all countries where Lilly was selling the product , and that commitment is up .

Speaker #2: In July . So at that time , we are likely to discontinue from a handful of countries . There's several countries where either the regulatory requirements are very hard and expensive , or their sales are just very minimal .

Speaker #2: So those are the two things that we're looking at . So that will offset some of the price . Some of the growth in the US .

Speaker #2: But we do still see this as growing this year , especially in the first half of the year . As you know , the international sales will keep going on until until the third quarter .

Bill Peters: We do still see this as growing this year, especially in the first half of the year, as, you know, the international sales will keep going on until Q3.

Speaker #2: And for your a07 question , the data for last year was 112 million . We think that there's a meaningful market share for being the the first and having 180 days of exclusivity with the product .

Dan Dischner: For your AMP-007 question, the Atrovent data for last year was $112 million. We think that there's a meaningful market share for being the first and having 180 days of exclusivity with the product. There's a meaningful opportunity for us. We don't currently have any visibility into whether an authorized generic could or will be launched. As far as the decline, I think we saw that mostly as a more of a pricing decline last year and not so much in a demand decline, demand driven. We think it's fairly stable at this point.

Speaker #2: There's a meaningful opportunity for us . We don't currently have any visibility into whether authorized generic could or will be launched . But as far as the the decline , I think we saw that mostly as a more of a pricing decline last year and not so much in a demand decline .

Speaker #2: Demand driven . So we think it's fairly stable at this point . Usually when you see a market go generic , you'll see that tend to stabilize because of the price considerations and because of payers wanting that people on a generic product .

Bill Peters: Yeah, usually when you see a market go generic, you'll see that tend to stabilize because of the price considerations and because of payers wanting to have people on a generic product. We think that this will lead to stabilization in terms of units for the product.

Speaker #2: So we think that this will lead to stabilization in terms of units for the product

Speaker #5: Got it . So I guess just a follow up . If there's no AG , would that be an upside to this mid to high single digit growth expectation for this year ?

Serge Belanger: Got it. I guess just a follow-up. If there's no AG, would that be an upside to this mid to high single-digit growth expectation for this year?

Speaker #2: I'll say it's you potentially one of the differences between mid and high single digits

Bill Peters: I'll say it's, you know, potentially one of the differences between mid and high single digit.

Speaker #1: Our next question is from Paisarn Patel with Bank of America

Operator: Our next question is from Pavan Patel with Bank of America.

Speaker #6: Hey guys . Thanks for taking my questions . My first is on gross margins . I know you commented that you expect it to be lower in 2026 , but maybe if you can help me understand to what degree pricing pressure on glucagon and epinephrine and these legacy products can be offset by growth .

Pavan Patel: Hey, guys. Thanks for taking my questions. My first is on gross margins. I know you commented that you expect it to be lower in 2026, but maybe if you can help me understand to what degree pricing pressure on glucagon, epinephrine, and these legacy products can be offset by BAQSIMI growth. Maybe if you could just frame the sizing between those pushes and pulls there. My second question is with regards to buybacks. I know you said that you plan to use a portion of your cash, and you have about $300 million of cash, so maybe if you're able to help me size what proportion of that is gonna be used potentially for buybacks versus BV. If you can't speak in terms of, like, absolute value numbers, totally fine.

Speaker #6: Maybe if you could just frame the sizing between those pushes and pulls there . And then my second question is with regards to buybacks , I know you said that you plan to use a portion of your cash and you have about 300 million of cash .

Speaker #6: So maybe if you're able to help me size , what proportion of that is going to be used potentially for buybacks versus BD ?

Speaker #6: And if you can't speak in terms of absolute value numbers , totally fine . If you could just frame which is a higher priority , that would also be helpful .

Pavan Patel: If you could just frame, which is a higher priority, that would also be helpful. Thank you.

Speaker #6: Thank you .

Speaker #2: Yeah , sure . So Baqsimi that that will definitely help us grow our gross margins next year because two things . One , the growth in the United States of the sales there and two , in the second half of the year , the countries where we'll discontinue it have negative gross margins .

Bill Peters: Yeah, sure. BAQSIMI, that, you know, that will definitely help us grow our gross margins next year, because two things. One, the growth in the United States of the sales there. Two, in the second half of the year, the countries where we'll discontinue it have negative gross margins, so we're actually losing money in those countries. That will help our margins. However, the glucagon reduction is fairly large. Those products, the epi vial and the fentanyl citrate, also are high margin products, and we're expecting to see sales declines in those products as well. As well as we're seeing just cost increases from our vendors or our suppliers at this time. That's also eating into the margins.

Speaker #2: So we're actually losing money in those countries so that that will help our margins . But however , the glucagon reduction is fairly large .

Speaker #2: And so those products , the EPI and the phytonadione also are high margin products . And we're expecting to see sales declines in those products as well as well as we're seeing just cost increases from our vendors and our suppliers at this time .

Speaker #2: So that's that's also eating into the margins . Also , another thing I didn't mention is that we did mention the higher API sales from our China business next year .

Bill Peters: Also another thing didn't mention is that we did mention the higher API sales from our China business next year. That's gonna be at a generally lower than corporate average gross margin as well, which will impact the overall margins. As far as buybacks go, we have about last year we did about $75 million in buybacks. I think that would be like the high end of the range for what we have. We have about $15 million left on the current buyback as of today. We did buy back some stock in January and February as well. We're likely to authorize have another authorization later this year.

Speaker #2: That's going to be at a generally lower than corporate average gross margin as well , which will impact the overall margins . And then as far as buybacks go , we have about last year we did about $75 million of buybacks .

Speaker #2: I think that would be like the high end of the range for what we are , what we have , we have about $15 million left on the buyback as of today .

Speaker #2: So, we did buy back some stock in January and February as well. So we're likely to have another authorization later this year.

Speaker #2: But a lot of it will depend on do we have business development opportunities and how close are we to potentially executing on those likely to slow the buyback down if we have a have a need for cash utilization

Bill Peters: A lot of it will depend on, you know, do we have business development opportunities, and how close are we to potentially executing on those, likely to slow the buyback down if we have a need for cash utilization.

Speaker #1: Our next question is from David Amsellem with Piper Sandler.

Operator: Our next question is from David Amsellem with Piper Sandler.

Speaker #7: Hi . Thank you . This is Naoki on for David . Just a couple from us . First , regarding Primatene mist , how are you thinking about competition for the product ?

[Analyst] (Piper Sandler): Hi. Thank you. This is now Keon for David. Just a couple from us. First, regarding Primatene MIST, how are you thinking about competition for the product considering that the patent expires this year? Can you also remind us about lifecycle management activities for the product? That's one. Number 2, how should we think about the cadence of filings this year compared to prior years? Is your primary focus on inhalation products? Thank you.

Speaker #7: Considering that the patent expires this year ? And can you also remind us about lifecycle management activities for the product ? So that's one .

Speaker #7: Number two , how should we think about the cadence of filings this year compared to prior years ? And is your primary focus on inhalation products ?

Speaker #7: Thank you

Speaker #2: So, pricing—the patent has already expired. So we don't see any competition now. We think it's unlikely to, given the economics for this.

Bill Peters: Primatene, the patent has already expired, so we don't see any competition now. We think it's unlikely too, given the economics for this. We think, you know, you know, it's a strong product.

Speaker #2: We think , you know you know it's a strong product . Yeah I think I think with the OTC market it's a different dynamic when it comes to generics .

Tony Marrs: Yeah. I think with the OTC market it's a different dynamic when it comes to generics. You know, Primatene Mist has 60 years of brand equity in it. We feel like we're in a good position, even if there was competition, we're in a good position of maintaining a large market share with that product. At the same time we're in the process of developing a new formulation of Primatene Mist. We've secured 1 patent and we're currently working on another. That's kind of our strategy as we move through that brand. The second question was about the cadence of the filings. We expect late this year, early next year to have 2 filings, and then next year total 2 to 3 filings.

Tony Dolin: Yeah. I think with the OTC market it's a different dynamic when it comes to generics. You know, Primatene Mist has 60 years of brand equity in it. We feel like we're in a good position, even if there was competition, we're in a good position of maintaining a large market share with that product. At the same time we're in the process of developing a new formulation of Primatene Mist. We've secured 1 patent and we're currently working on another. That's kind of our strategy as we move through that brand. The second question was about the cadence of the filings. We expect late this year, early next year to have 2 filings, and then next year total 2 to 3 filings.

Speaker #2: You know , Primatene mist has 60 years of of brand equity in it . And so we feel like we're in a good position , even if there was competition , we're in a good position of maintaining a large market share with that product .

Speaker #2: And at the same time, we're in the process of developing a new formulation of Primatene Mist. We've secured one patent, and we're currently working on another.

Speaker #2: So that's kind of our strategy as we move through that franchise on the second , the second question was about

Speaker #4: Cadence of the filing. So we expect late this year, early next year, to have two filings in. Then, next year, total filing.

Tony Marrs: We think that should be the cadence moving forward.

Speaker #4: And we think that should be the cadence moving forward

Tony Dolin: We think that should be the cadence moving forward.

Speaker #1: Our next question is from Ben Burnette with Wells Fargo Hi . Hello . This is calling in for

Operator: Our next question is from Ben Burnett with Wells Fargo.

Tianxi: Hi. Hello, this is Tianxi calling in for Ben. Thanks for taking our question. Wanted to ask you about the Nanjing Anji set in licensed assets. Just see if you can have any updates on that. What kind of level of confidence do you have on these assets? What does the clinical development path look like in their respective indications? Thank you very much.

[Analyst] (Wells Fargo): Hi. Hello, this is Tianxi calling in for Ben. Thanks for taking our question. Wanted to ask you about the Nanjing Anji set in licensed assets. Just see if you can have any updates on that. What kind of level of confidence do you have on these assets? What does the clinical development path look like in their respective indications? Thank you very much.

Speaker #5: Ben . Thanks for taking our question . So I wanted to ask you about the Nanjing Ng In-licensed assets . Just see if you can have any updates on that .

Speaker #5: What kind of level of confidence do you have on these assets , and what does the clinical development path look like in their respective indications ?

Speaker #5: Thank you very much .

Speaker #4: Yeah , we're very excited about those products . We are currently in the pre-clinical stage of those . We're getting the getting our packages together to have conversation early conversation with the agency on it .

Tony Marrs: Yeah, we're very excited about those products. We are currently in the preclinical stage of those. We're getting our packages together to have early conversation with the FDA on it. We think these products are very exciting. Internally we have a lot of positive excitement around them. We're building teams and coming up with priorities of these projects. These will be new drugs, so they'll be going through the standard NDA process. Whether we have expedited pathways or not remains to be seen. We're optimistic that we should have some for those. We have some oncology products that we think likely will have some of that, but we've not yet engaged the FDA with conversations of that.

Tony Dolin: Yeah, we're very excited about those products. We are currently in the preclinical stage of those. We're getting our packages together to have early conversation with the FDA on it. We think these products are very exciting. Internally we have a lot of positive excitement around them. We're building teams and coming up with priorities of these projects. These will be new drugs, so they'll be going through the standard NDA process. Whether we have expedited pathways or not remains to be seen. We're optimistic that we should have some for those. We have some oncology products that we think likely will have some of that, but we've not yet engaged the FDA with conversations of that.

Speaker #4: We think these products are very , very exciting internally . We have a lot of positive excitement around them . We're building teams and coming up with priorities of these projects .

Speaker #4: These will be new drugs, so they'll be going through the standard NDA process. Whether we have expedited pathways or not remains to be seen.

Speaker #4: We're optimistic that we should have some for those . We have some oncology products that we think likely will have some of that , but we've not yet engaged the FDA with conversations of that .

Speaker #4: But we're just kind of in the in the preclinical evaluation of of that . And looking at the prioritization of that . But overall , I think we're very , very excited , encouraged by these products

Tony Marrs: We're just kind of in the preclinical evaluation of that and looking at the prioritization of that. Overall, I think we're very excited, encouraged by these products.

Tony Dolin: We're just kind of in the preclinical evaluation of that and looking at the prioritization of that. Overall, I think we're very excited, encouraged by these products.

Speaker #1: Thank you . There are no further questions at this time . I would like to hand the floor back over to management for any closing remarks .

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

Speaker #2: Thank you , Paul , and thank you all . Once again for joining . We appreciate continued engagement and support , and we look forward to keeping you updated on our progress throughout 2026 .

Dan Dischner: Thank you, Paul. Thank you all once again for joining us today. We appreciate your continued engagement and support, and we look forward to keeping you updated on our progress throughout 2026. Have a wonderful evening. This concludes today's conference call. You may disconnect your lines at this time. Thank you again for your participation.

Speaker #2: Have a wonderful evening

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

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