Amphastar Pharmaceuticals (NASDAQ:AMPH) Q3 2026 Earnings Call

0:00 Greetings and welcome to the Amphistar Pharmaceuticals, Inc. third quarter earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow a formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note that certain statements made during this call regarding matters that 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 this 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.

0:49 We 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.

1:21 Thank you, Paul. Good afternoon, everyone, and thank you for joining Amphistar's third quarter 2026 earnings call. Earlier today, we reported our financial results for the third quarter ended September 30, 2026, which are available on the investors' page of our website. The third quarter was marked by record commercial performance, continued progress on our IMS remediation efforts, and further advancements of our development pipelines. We achieved quarterly revenue of $207.6 million, up approximately 8% year-over-year and 13% sequentially. Growth was driven primarily by strong performance from Baximi and Primatine Mist, supplemented by contributions from recently launched products.

2:09 Gross margin decreased during the quarter, primarily driven by the impact of lower net pricing on certain products and higher manufacturing expenses, including costs associated with the remediation efforts at our IMS manufacturing facility. Bill will provide additional detail on these factors as well as the year-over-year earnings comparison in the financial review. Our strategy remains focused on three complementary growth priorities. First, maximizing the growth of Baximi and Primatine MIS while expanding our differentiated commercial portfolio. advancing our pipeline of complex generics and biosimilars. And third, progressing our proprietary development program.

2:57 Our scientific, manufacturing, and commercial capabilities support each of these initiatives. I would like to provide an update on each, beginning with our commercial portfolio. Vaccini delivered record quarterly net sales of 58.8 million, representing growth of approximately 10% compared to the prior year's period. The increase was driven by higher unit volumes partially offset by lower net pricing associated with commercial discounts and customer mix. During the quarter, the measures we implemented to address duplicate 340B discounts continued to produce results, further reducing their impact relative to the second quarter. We remain focused on driving prescription growth, expanding patient access, and executing our commercial strategy to maximize the long-term value of the franchise.

3:50 Private Key Miss delivered record quarterly net sales of 31.5 million, an increase of approximately 9% compared to the prior year's period. Growth was driven by both the price increase implemented in the second quarter and higher unit volumes with in-store unit sales increasing approximately 2.5% year-over-year. These results highlighted the strength of our commercial operations and our ability to successfully manage differentiated pharmaceutical products across multiple markets and distribution channels. More recent product launches also contributed meaningfully during the quarter. Specifically, Ipitropium bromide, which launched in April, generated $6.6 million in sales, while teriparatide contributed $6.4 million.

4:38 These launches supported overall portfolio growth and partially offset headwinds affecting certain established products, including glucagon injections. Our commercial portfolio continues to provide the cash flow and operational foundation needed to invest in the development, manufacturing, and commercial capabilities that support our pipeline of complex generics, biosimilars, and proprietary medicine. During the quarter, we continue to invest in manufacturing initiatives that support both our existing portfolio and future growth opportunities. and activities related to our insulin and proprietary development program. Our US-based manufacturing footprint and vertically integrated operating model remain important competitive advantages as we prepare for future product launches.

5:25 We also remain focused on addressing matters related to our IMS facility. Following the FDA's warning letter received earlier this year, we continue to implement corrective actions and advance our remediation efforts. These activities affected production schedules, and the timing of certain product releases during the quarter, resulting in lower sales of certain IMS manufacturing products and higher manufacturing expenses. It is important to note the impact to date has been primarily operational in nature rather than demand related. We continue to work closely with the FDA while maintaining the supply of essential medicines, including products that help address ongoing drug shortages. At the same time, we remain committed to fully addressing the agency's observations, maintaining the supply of important medicines, and achieving sustainable improvements in our quality and manufacturing system. Bill will provide additional detail on the financial impact of these activities, our current expectations for remediation-related spending, and our broader business outlook. Turning to the second and third pillars of our growth strategy, we continue to make progress across our development pipeline during the quarter.

6:39 For our Insulin Aspart Biosimilar and Interchangeable Program, we remain on track to support a potential commercial launch in 2027, subject to FDA approval. During the quarter, we advance the clinical and manufacturing activities needed to support the program and continue preparing for commercialization. Development activities also remain ongoing across our broader biosimilar portfolio, as well as additional complex inhalation and injectable product candidates. Our proprietary pipeline also remains an important part of our long-term growth strategy. For AMP 101, our intranasal epinephrine program, we continued clinical development activities following the initiation of our phase one program in the second quarter. In the third quarter, we refined the study design and formulation based on regulatory feedback as we continue to advance the clinical development program.

7:33 We believe AMP 101 has the potential to provide patients with an additional non-injectable treatment option for severe allergic reactions, including anaphylaxis. For AMP109, our peptide coupled doxotexyl oncology program, we continued non-clinical studies and manufacturing preparations during the quarter, building on the constructive FDA feedback received earlier this year regarding our proposed development approach. We also continued development of AMP110, are synthetic human corticotropin program, including the evaluation of potential therapeutic indications and additional non-clinical studies to support a clinical development program. Development activities also continue for AMP107, our proprietary ophthalmic program targeting wet age-related macular degeneration and diabetic macular edema. Our goal is to develop a differentiated eye drop treatment Alternative for conditions currently treated primarily through interocular injection, which we believe significant unmet needs remain.

8:43 While these programs remain in early stages of development, we believe they represent meaningful long-term opportunities, and we are focused on disciplined investment as we advance them toward key development milestones. I will now turn the call over to Bill Peters, our CFO and Executive Vice President of Finance, for a more detailed third quarter financial review. Bill?

9:05 Thank you, Dan. Good afternoon, everyone. In my comments today, I will discuss the third quarter results and then update some of our assumptions for 2026. Revenues for the third quarter increased 8% to $207.6 million, which is the highest amount we have ever recorded in one quarter. This compares to $191.8 million of revenue in the previous year's period. at Protoprium Bromide Inhalation, which we launched in April, led the growth with strong sales of $6.6 million. Vaccine revenues increased 10% to $58.8 million compared to $53.6 million in the prior year period, primarily due to an increase in units sold, contributing $7.4 million in sales driven by our continued marketing effort.

9:54 This increase was partially offset by lower average selling prices, which negatively impacted sales by approximately $2.2 million, primarily as a result of higher rebates and higher 340B pharmacy discounts, some of which may have been duplicated. Although rebates and 340B discounts remained a year-over-year pricing headwind, the impact was significantly smaller than in the previous two quarters, reflecting the positive impact of the measures we implemented to identify and resolve potential duplicate 340B discounts. Primatine mid-sales rose 9% to $31.5 million in the third quarter, up from $28.8 million in the third quarter of last year, due to both a recent price increase and an increase in unit volume, as we continue to see strong in-store demand.

10:48 Bills of lidocaine increased 29% to $16.6 million from $12.9 million in the prior year's period, driven by higher demand due to a shortage from another supplier. Epinephrine sales decreased 19% to $15.3 million from $18.8 million in the prior year period, primarily due to slower product releases at our IMS facility as a result of the remediation efforts related to the FDA warning letter. Glucagon sales declined 37% to $8.6 million from $13.6 million due to increased competition. Other pharmaceutical product sales increased 9% to $70.2 million from $64.1 million, primarily due to sales of teraparotide contributing $6.4 million, which we launched in December 2025.

11:37 API sales of $6.2 million from our ANP subsidiary also had a positive impact on sales. These increases were partially offset by a decrease in sales for several IMS products as a result of the remediation efforts at that facility. Cost of revenues increased 16% to $108 million from $93.2 million, and gross margins decreased to 48% of revenues in the third quarter of 2026 compared to 51% in the previous year's period. The primary drivers of the change were lower average selling prices for Beximi, Glucagon, and our epinephrine multi-dose file product. Additionally, we had increased manufacturing costs at our IMS facility related to the remediation efforts. These factors were partially offset by sales of recently launched products at higher margins, such as infratropium bromide and teriparatide.

12:34 Selling, distribution, and marketing expenses increased 4% to $11.9 million from $11.5 million, primarily due to higher freight expense. General and administrative spending decreased 57% to $16.8 million from $39.5 million, primarily because the prior year period included illegal settlement. Research and Development Expenditures decreased 10% to $20.1 million from $22.3 million as the previous year period included a one-time payment for a licensing agreement. This decrease was partially offset by higher expenses for our insulin and proprietary product pipeline. Our non-operating expenses of $1.7 million during the period compared to non-operating expense of $3.8 million in the prior year period primarily due to foreign currency fluctuations as well as market-to-market adjustments related to our interest rate swap.

13:34 Net income in the third quarter increased to $37.8 million and increased on a per share basis to 87 cents from $17.4 million or 37 cents per share in the third quarter of 2025. Adjusted net income rose to $49.3 million or $1.14 per share in the third quarter compared to an adjusted net income of $44.7 million, or $0.93 per share, in the third quarter of last year. Adjusted earnings exclude amortization, equity compensation, impairment of long-lived assets, and one-time events. In the third quarter, we had cash flow from operations of approximately $43.3 million. Separately, our board of directors authorized an additional $50 million for our share buyback program.

14:24 Looking ahead to the fourth quarter, we expect sales to increase in the high single-digit range compared to the fourth quarter of last year. This guidance incorporates a modest slowdown in IMS sales as we prioritize corrective actions to strengthen our quality manufacturing system. I will now turn the call back over to Dan. Thank you, Bill.

14:44 The third quarter reflects continued execution across our business, led by record sales of Baximi and Primatine Mist. along with contributions from recently launched products. These results reinforce the value of our commercial platform we have built to provide an important foundation for our long-term strategy. We also continue to make progress on several important operational and strategic initiatives during the quarter. At IMS, we advanced our remediation efforts and continue working closely with the FDA while maintaining supply of essential medicines. Across our development portfolio, we continue to advance our complex generics, biosimilars, and proprietary programs while maintaining a disciplined approach to capital allocation and investment. We believe Amphistar is well-positioned as a diversified pharmaceutical company with established commercial products, a US-based manufacturing footprint, vertically integrated capabilities, and a growing pipeline of differentiated opportunities.

15:49 Our priorities remain clear. Sustaining commercial performance, strengthening our operations, advancing our pipeline, and creating long-term value for our shareholders. With that, we will take your questions. Paul? Thank you. We'll now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 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 poll for questions. Thank you. Our first question is from Ekaterina Nyakova with JP Morgan.

16:36 Thanks so much. So first it's just on vaccine, and I think you've mentioned this, but just in terms of the double dipping, how much of it has been addressed at this point? I remember you were targeting 80%. Just how close are we to that 80% and is that still the target or do you think you can kind of even go beyond that? And then second question is just, you know, I know it's early, but just as you kind of start thinking about 2027, just any early thoughts on, you know, pushes and pulls both on the revenue side and EPS side as we think about next year? Thanks.

17:05 Sure. On the first question, we're not at that 80% yet, but we're getting closer. We don't think we'll get past that, because that's where the other companies that are using the same resources have gotten to. So we think there's a little bit more room to go, but not a lot. As I mentioned, we still had a $2.2 million headwind this quarter from pricing. That was primarily, I think, these duplicate discounts. As you can see from the numbers, it was a lot better than it has been for the last two quarters, so we're really happy with the progress we've made there. Looking forward to 2027, we're not prepared to give guidance at this point, but I will say that we are still expecting strong growth from Baximi, growth from primatine mist, annualized sales of vitratropium bromide, so we have a lot of positive things for next year.

17:58 And then if I can squeeze in one more, just on the IMS facility and the remediation, can you just quantify the impact in Q3 a bit more as, you know, 5 million, 10 million, and just how should we think about impact in the fourth quarter and any impact that we should potentially think in 2027? Sure.

18:15 So it's probably between $2 and $3 million of extra expense in this quarter, and it'll probably be a little bit higher than that in each of the next two or three quarters. Thank you. Thank you. Our next question is from David Amsalem with Piper Sandler. Hi, this is Naoki on for David. Thank you for taking our questions. The first one on vaccine, as you work through the duplicate discounting issue, is it reasonable to expect some net pricing recovery toward historical levels in 2027? So that's number one. And next, also on vaccine, scripts have continued to look strong here. So can you give us some color on what's driving the growth? Are these new patients of the category switches?

19:00 Any color would be helpful here. Thank you.

19:04 Sure. So we don't think we'll get back to the pricing that we had previously because of this double dipping. And even the 3% price increase that we took this year doesn't fully offset that. So we still have that pricing headwind going into next year. But remember, we had a bigger pricing problem in the first quarter of last year because that's when the peak double discounting. So we'll have some easier comps as we move on into the year. And then what's driving the growth?

19:40 Primarily is our marketing commercialization efforts. It's sort of how we've expected since we acquired the product to be at around these levels. Maybe it's a little higher than we expected, but it's right around where we expect it. is bringing awareness to vaccine and our team has been working on those efforts throughout. So I think that's really what's driving the growth.

20:08 Great. Thank you. Our next question is from Dennis Ding with Jefferies.

20:17 Hey, guys. Thanks for taking my questions. I have two. So in regards to the INS, It sounds like it'll be mid-2027 before it gets back to full capacity. How involved is the FDA in doing some of these quality control checks, or how involved are they in the process? And is there a risk of them having to shut down that specific prefilled syringe line? And then question number two on ipratropium. It's annualizing at around 25 million, but I believe historically you've characterized this as a $50 million opportunity. Given that we haven't seen an AG yet, do you expect this to keep growing and we eventually get to $50 million, or what's gating that from happening?

21:05 Thanks so much.

21:08 Yeah, Dennis, for your first question about the IMS facility, we send routine updates to the agency. We gave them an overall plan. and this is in conjunction with working with our third party partner and essentially we just provide routine updates to them on the progress of each of the different work streams that we're working through. So the progress of that is going very well. We're progressing through it and we'll continue those updates into the year.

21:40 And also to add on that, the FDA was looking for several things specifically and what we've done is a more comprehensive plan. So we're working on things that weren't even asked for by them as well. So there's multiple things that we're working on all at once. We will continue to work on that. And as far as getting back to capacity, I think we're pretty close to actually being there because part of what we had to do was add some additional resources to the quality group to help because we've added some controls there. And because we've added these controls, we needed some more resources. So now we're adding those resources

22:17 and we think that we should be able to pick up relatively soon back to where we were before.

22:24 And as far as the procuring goes, yeah, we think that sales should continue to increase from where we were this quarter because what we've seen is that we had a little bit of loading in the second quarter so that was partially why the third quarter was a little lower than the second quarter. But what we're seeing is continued share growth for our market share. So as those prescriptions keep to grow, we expect that our sales will continue to grow. And we don't know when there will be another generic, but as of right now, we are the only generic in that market. Perfect. Thank you. Our next question is from Serge Bellinger with Needham & Company.

23:13 Good afternoon. Thanks for taking my questions. First one, regarding lidocaine, looks like you benefited from some supplier shortages. Do you expect these shortages will continue being a benefit into 2027? And then secondly, as we approach 2027 and look at the potential new launches, I think you've talked about the GLP-1 generic, which is expected to be competitive. as well as the insulin biosimilar. I'm just curious if you could frame the opportunity of the insulin biosimilar. Could it be another opportunity similar to the ipratropium launch or will it be drastically different from that?

24:04 Thank you.

24:06 Yeah, as far as the lidocaine goes, we do expect the demand for that product to continue into next year. But it does become a matter of overall resources on what we were able to deliver from that facility because of the tightness that we've had into the things. So if you take a look at our 10Q, which we put out today, one of the things is that we have a larger backorder from that facility than we've had in the past. It's up to $12.5 million now. So we have competing demands on our resources there. We were able to ship lidocaine this quarter. We plan and intend to try to get out as much as we can next quarter. But as of right now, we do see the demand for that product continuing to hold up, as well as demand for other products that we weren't able to execute on yet.

24:57 The new launches, as we pointed out before, on A&P 018, We do expect that to be a limited opportunity for us due to the competitive nature of that environment. However, we do remain on track for the 2027 commercialization. And then the insulin biosimilar, our insulin Aspart product, we also know that there's three or four competitive generics already in the market. So we've said all along it's a large market. We feel like there is still room for us to fit into that. Thank you.

25:44 Our next question is from Jason Gerberry with Bank of America.

25:50 Hey, guys. Thanks for taking my question. Just wanted to tease out a little bit, if you can, to sort of, you know, the drag on gross margins this quarter. Was that mainly IMS? Was it more the Baximi price? called out, and when would you kind of expect GMs to kind of bounce back to kind of more normalized levels? Thanks.

26:12 Sure. So a pricing issue more than anything else, and that pricing reduction comes from Baximi and from Glucagon and from the EpiVial. So we had three products that were high-margin products that had some margin pressures on them. Additionally, we did have that increase to $3 million of expense at IMS, plus some additional expense at the Amphistar facility as we're building out some, as we've taken on some new capacity here. So I think in order to get the gross margins back to where they were, I think we need to get our volumes up a little higher with some things. And I think one of the things that could do that is the insulin ask part, because that'll be taking advantage of both Thank you.

27:15 Our next question is from Glenn Santangelo with Barclays.

27:20 Yeah, good afternoon. Thanks for taking my question. Just two quick ones for me. You know, Bill, I want to talk to you about sort of the other category. I mean, you put a pretty decent growth there, and you called out specifically Terra Paratide and the API sales. And, you know, we're obviously, I think, going to launch the or get to the anniversary of the launch of Terra Paratide. And so I'm just trying to think about the durability of that growth as we head into 2027. Any sort of commentary you can give us around that I think would be helpful. And then secondly, you know, as you look to 2027, I also wanted to follow up on the insulin biosimilar. I mean, it feels like the company's sort of biggest incremental opportunity in 27. I was wondering if you could maybe just give us a little bit more detail about, you know, sort of probability of that launch, the timing of that launch, the margin profile of that product. Anything you can sort of, you know, give us to help us think about that opportunity would be helpful. Thanks.

28:20 Sure, as far as the other income goes, you know, you're right, Terra Paratide does annualize into the fourth quarter this year, but, you know, the sales of that are holding up strong, so maybe we don't get growth out of that, but I think we still will have strong sales. Additionally, with the API sales out of the A&P facility. We've had two quarters of about the same level of sales and we expect sales to continue around that level. However, those are a little bit lumpy because they're shipping out batches of API one at a time and sometimes the timing of those things can be a little off from our quarterly growth. The other thing is, I'll just go back to what I was saying on the last question, which is We have a growing backlog because of some of the increased controls that we added at the IMS facility.

29:15 So we have an opportunity there as well to reduce that backlog. And so there were several products in that other category where we were unable to ship because of some of the things we were doing there. So our goal for this quarter would be to reduce that backlog and get those sales out. And then as far as the insulin biosimilar, we've set a next year launch. If it was, I'll say, imminent, then we'd probably talk about a first quarter launch. So it's not something that we can really, you know, we don't have a firm date on that launch at this point. Our next question is from Ben Burnett with Wells Fargo.

30:10 Good afternoon, Bill and Tim. This is Orpheus on for Ben. Thank you for taking our question. There seems to have been a small delay in the AMP005 and 017 filings from the first half of 27 to the second half. Do you want us to understand what drove that? Would the delay be related to data, FDA feedback, or is it more of a capacity issue? Thank you very much.

30:35 I wouldn't categorize it as any of those. I think it's just a normal development process delay. Nothing in particular as far as an interaction with the FDA or anything like that. I think it's just a normal part of the development process. Thank you. And if I may, just quickly on A&P 104, we noticed that's a next-generation pre-modeling program in your pipeline. Do you help us understand what drove the new program and what the development path looks like there? And secondly, would you expect it to extend Primatine's IP protection? Thank you.

31:12 Yeah, so this is the new Primatine mist formulation that we've been talking about for a little while now. It has a lower global warming potential. We're just including that on the proprietary slide. We haven't included it in the past, but we wanted to add it there just to give some people an idea of the timeline for that. and yeah, we've already filed and have one patent approved and we've filed another one. So we're hoping to have significant patent protection on that product as well. And we just thought we'd add it to the deck so you'd understand our goal is to file that by the end of 2028. So we think it's an important development to protect the long-term primatine mist brand.

31:58 and I'll add a little bit of context to that is the EPA has drawn back some of the, is on a draw down for HSA and so this is something the FDA has taken to eventually get rid of that as a propellant and so this is just our development program to maintain being compliant with those regulations. Makes sense, thank you. Thank you. There are no further questions at this time. I'd like to hand the floor back over to management for any closing remarks.

32:37 Thank you, Paul, and thank you all for your questions today. We appreciate your continued interest in Amphistar and look forward to updating you on our progress next quarter. Have a great day.