Greetings and welcome to the Amphastar Pharmaceuticals Fourth Quarter Earnings Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] 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. 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. We will also discuss certain non-GAAP measures. Important information on our use of these measures and reconciliation to U.S. GAAP may be found in our earnings release. Please note, this conference call 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.

Thank you, Paul. Good afternoon and thank you for joining us today for our fourth quarter earnings call of 2024. Joining me on the call will be Bill Peters, CFO and Executive Vice President of Finance; and Tony Marrs, Executive Vice President of Regulatory Affairs and Clinical Operations. Earlier today, we announced our financial results for the 2024 fiscal year, achieving revenues of $732 million, a strong 14% increase compared to the prior year. For the fourth quarter alone, we recorded $186 million, demonstrating a solid 5% year-over-year growth. This performance highlights the resilience of our portfolio, driven by contributions from key products such as Primatene MIST and the integration of BAQSIMI into our expanding diabetes franchise. As we concluded the fourth quarter, BAQSIMI operations have fully transitioned to Amphastar and distribution responsibility is now completely under our control. Building on this momentum, we are thrilled to announce a new strategic partnership with MannKind. Effective January 1 of this year, MannKind's experienced sales force has started promoting BAQSIMI, expanding our sales reach. This collaboration represents a strategic step towards -- forward in amplifying BAQSIMI's growth trajectory and strengthening our position in the diabetes care market. Primatene MIST, a cornerstone of our branded product offering has reached a significant milestone with annual sales of $102 million, representing a 14% increase from 2023. Continuing to build on that momentum, we are pleased to announce that as of late January, our physician sampling program has been expanded with the launch of our pilot sales program targeting primary care physicians and enhancing our market penetration and engagement with health care providers. As we look to the future, we remain confident that Primatene MIST and BAQSIMI will continue to be key contributors to our revenue growth through 2025. These products highlight our ability to innovate…

Thank you, Dan. Sales for the fourth quarter of 2024 increased 5% to $186.5 million from $178.1 million in the fourth quarter of 2023. Total BAQSIMI sales at the factory level grew 12%, with BAQSIMI contributing $41.8 million to Amphastar's net product sales. Lilly sales of BAQSIMI totaled $300,000 which led to a net economic benefit of negative $455,000 after a true-up of certain expenses. Throughout the year, Amphastar's BAQSIMI sales have increased, while the net economic benefit has decreased as we have taken over distribution responsibilities of BAQSIMI in various countries around the world. As of January 1, 2025, we assume distribution responsibilities for BAQSIMI in the final 2 countries. Primatene MIST continues to show strong sales growth during the quarter with sales of $28.9 million, up 18% from $24.5 million in the prior year period. For the year, Primatene MIST sales were $102 million, surpassing our $100 million annual goal we set 3 years ago. Glucagon sales declined to $25.6 million from $31.2 million in the prior year period due to increased competition and a market move to ready-to-use products such as BAQSIMI. Epinephrine sales declined to $18.7 million from $24.6 million in the previous year's period due to increased competition for our epinephrine vial product. Gross margins decreased to 46.5% of revenues in the fourth quarter of 2024 compared to 54% of revenues in the fourth quarter of 2023, primarily due to BAQSIMI sales which were recorded net of Lilly's expenses in the prior year, so there was no associated cost of sales. We were also impacted by higher labor and component costs. Strong sales of higher-margin Primatene MIST partially offset this trend. Selling, distribution and marketing expenses increased 21% to $10.4 million from $8.6 million due to the expansion of our sales and marketing efforts for…

[Operator Instructions] Our first question is from Jason Gerberry with Bank of America.

I just -- I know you guys aren't offering any 2025 guidance but I was wondering if you could speak to your outlook on Primatene MIST and glucagon heading into the next year. Those seem like the key products to me. Thanks in advance.

Yes. So Primatene MIST, we are going to -- we're expecting to see single-digit sales growth, high single-digit sales growth for that product. For BAQSIMI, as I mentioned, we took a 3% price increase in the United States. The United States is about 80% of the sales for that product. Additionally, we're expecting to see high single-digit unit growth for that product. And glucagon, because of the increased competition, we're expecting both pricing and unit volume drops for that product.

Our next question is from Cerena Chen with Wells Fargo.

Congrats on the solid quarter. I was wondering for the products with GDUFA dates coming up in Q2, AMP-007 and 018, how prepared are you to launch these products if they do get approved. And for the GLP-1, are you aware if competitors have generally been able to get first cycle approvals? Or do you think this product typically requires more review cycles?

As far as preparing to launch with these products being on their first cycle, our thought is that we probably wouldn't be ready to launch until the following quarter. So if it's a second quarter approval, then we would launch it in the third quarter. I'll turn it over to Tony for the other portion of that question.

Yes. For the GLP-1s, we think first cycle reviews are possible. But given that these are peptide type products, I think it's optimistic for that for the majority of companies.

Our next question is from Ekaterina Knyazkova with JPMorgan.

So first question is just on BAQSIMI. I know it's early but what kind of impact are you seeing from the expanded sales force and the collaboration with MannKind. Are you kind of seeing the kind of traction you're expecting? And maybe latest thoughts of how you're thinking about the commercial footprint beyond 2025? And then, second question is just on AMP-004. Just can you remind us how you're thinking about the size of that opportunity? And just the latest on timing, is this something that could potentially launch later this year? Or is this more 2026?

I'll start with the BAQSIMI question. Obviously, it's still a little early to tell. They just started detailing it in the beginning of January. But because of the -- we haven't disclosed the exact number but it's quite large -- quite a larger number of sales reps than what we've been utilizing. So we do expect -- and I also want to point out that they actually have experience in the endocrinology space. So we really feel like it's a great fit for us that they can get in and promote the product. So we're looking forward to that. And we'll keep you updated as that goes on. For AMP-004, have Tony kind of address that issue.

Yes. So as far as getting ready to participate in that market, we don't see that getting approved this year or probably it's unlikely to get approved until late next year. So that's something that we'll be prepared for at that time.

Our next question is from David Amsellem with Piper Sandler.

So I'm going to come back to the informal guidance topic or question. So you've got 2 products that you expect to be launching and that's in your numbers and then there's competition from the products you called out. I guess, a couple of questions on that is, you got GDUFA is on 3 products this year. Can you say which of the 3 is between 015, 018 and 007 you expect to launch? Are you factoring in risk-adjusted contribution from those products? And is there any way you can quantify how much in the way of new launches you're guiding to versus how much decline from competition you are expecting? I think that kind of color would be helpful.

Sure. So we've got 4 candidates that could be approved. And we actually think that there's a possibility of any of them being approved and possibility having contribution from all of them. So this is a risk-adjusted basis for 2. And what we've decided to do this year is as we took a look at the potential timing for these things, we're expecting, I'll say, fourth quarter sales from 2 products. So no new launches until then for our guidance and that's on a risk-adjusted basis. So it's certainly possible that it happens and we get some in the third quarter or even all 4 by the fourth quarter. But on a risk-adjusted basis, we think based on the way we see things and some uncertainty for some of these products that 2 of them is what we're looking at for the fourth quarter.

Okay. And if I may follow up, just is one of those 4 AMP-002 which I know has kind of been in flux since the GDUFA came and went back in 2023?

So I'll say on a risk-adjusted basis, it's possible but we think it's probably more likely that, that's a first quarter of 2026 event.

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

Few questions. I guess, first on BAQSIMI and the MannKind collaboration. Can you just give us a little more color on what the collaboration represents in terms of additional sales force regarding what you previously had and if they'll be targeting a different set of prescribers. And I guess, if it increases your peak sales estimates for the product? And secondly, just can you update us on the competitive overview of epinephrine and whether you expect Pfizer to come back in the market at some point? And when?

Sure. So let me start with the sales force of MannKind. With their sales force, that more than doubles the number of salespeople that are going to be detailing the product. So it covers more of the country than it had previously. Now keep in mind that for the MannKind portion of this, it's a secondary product for them. So they're detailing Afrezza first and BAQSIMI second but I think it's a really good product for them because it gets them -- gives them something else to talk about than Afrezza they've been talking about for a long while. I think it gets them into doctors' offices. So I think they're really excited about it and we're really excited about it, too. So we do think that it takes some time to get that ramp-up going and that going. So the way we're looking at it is that the sales should accelerate going into the latter half of the year as well. So that's another thing that we're looking at there. As far as epi goes, remember, we sell both the prefilled syringe and the multi-dose vial. And now there's 4 or 5 players now in the multi-dose vial. That's why we saw the epinephrine sales drop in the fourth quarter of last year. But on the prefilled syringe, as of right now, we're still the only player in the United States that's selling that product. So right now, it's us. Our competition there has repeatedly changed the date when they expect to get back into the market. So it's hard to say but I don't think it's the first quarter or probably not a second quarter event.

Thank you. There are no further questions at this time. I would like to hand the floor back over to Mr. Dan Dischner for any closing comments.

Thank you all for joining us on today's call. We are excited about the opportunities ahead, especially with 2 upcoming GDUFA dates in the second quarter. We will also provide updates on our branded proprietary and pipeline products in the future quarters. We look forward to sharing more information with you on our next call. Thank you. Have a good day.

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