AMPH - NASDAQ

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 and meet market demands, reinforcing our commitment to sustaining growth through branded products. Turning to glucagon; we recorded annual sales of $108 million in 2024. While this represents a modest 5% decline in the previous year, we expect glucagon to face increasing competitive pressures. Nevertheless, we view this as a natural evolution in a dynamic market for a generic product. Part of the market evolution in the glucagon space involves the shift to ready-to-use products such as BAQSIMI which we believe positions us to seize new opportunities in the coming year. Our hospital and clinic use products also experienced heightened competitive pressures in the fourth quarter. Despite these obstacles, we continue to benefit from ongoing drug shortages in other areas of our product portfolio. Given the cyclical nature of these shortages, we anticipate that similar market dynamics will persist throughout the coming year. Our diverse product portfolio and proactive supply chain strategy supported by our vertically integrated business structure are designed to effectively navigate these fluctuations, ensuring a consistent supply and strong competitive positioning in the market. Shifting the discussion to our regulatory and pipeline developments, we are optimistic about the potential approval of 4 key products in 2025. AMP-002; AMP-007, an inhalation product; AMP-015 which is teriparatide; and AMP-018 marking our GLP-1 ANDA. Regarding AMP-002, despite a delay in its GDUFA date since the second quarter of 2023, we continue to engage in proactive discussions with senior-level FDA officials. This product is still without a generic competitor and we expect further clarification on the optimal path forward in the coming months. For AMP-015 or teriparatide, we have completely responded to the CRL we received in the fourth quarter of this -- as of this month, with an anticipated GDUFA goal date in the second half of this year. Regarding our remaining ANDAs, both AMP-007 and AMP-018, both are progressing well with first cycle GDUFA goal dates in the second quarter of this year. Turning to our insulin BLA, AMP-004 or insulin aspart, we have refiled this application after further request from the FDA. Our commitment to achieving the highest technical standards remains firm, particularly as we work towards obtaining interchangeability status for insulin product. Turning beyond our ANDAs and diabetes portfolio, I'd like to offer brief comments on recent developments concerning international trade and Amphastar's current business strategy. Regardless of current or future U.S. trade policies and trade balances, we believe our vertically integrated business model positions us exceptionally well to mitigate any significant impact. Moreover, our robust U.S.-based manufacturing footprint where 100% of our finished products are produced domestically shields us from tariffs on finished pharmaceutical goods. This domestic production capacity ensures supply chain resilience and aligns with potential policy initiatives to bolster U.S. manufacturing. As we look to the future, Amphastar is optimistic about our growth as we shift our focus towards our branded and proprietary portfolio and pipeline. The year 2024 was particularly significant for us as we achieved a milestone of $100 million in sales with our proprietary product, Primatene MIST. Additionally, BAQSIMI has shown the expected growth potential and we continue to see positive trends for these products. I'm also pleased to announce that we will introduce more proprietary pipeline products by the end of this year. We are eager to share recent developments regarding these products, along with updates on the progress of our current filings towards approval and launch. I would like to hand the call over to our CFO and Executive Vice President of Finance, Bill Peters, to discuss the fourth quarter and year ending financial results.

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 BAQSIMI. General and administrative expenses remained relatively unchanged at $12.9 million compared to $13.1 million in the prior year. Research and development expenditures decreased 11% in the quarter to $18.1 million from $20.4 million in the comparable quarter of 2023, primarily due to lower spending on clinical trials and materials and supplies. Non-operating expenses in the fourth quarter of 2024 were $1.2 million compared to $12.6 million in the prior year period, primarily related to the accretion of the $129 million deferred cash payment to Lilly which was made in June 2024 as well as lower principal balance on our debt, foreign currency fluctuations and mark-to-market adjustments on our interest rate swaps. Additionally, in 2023, we wrote off unamortized debt issuance costs related to one of our term loans. The company reported net income of $34 million or $0.74 per share compared to the previous year's fourth quarter net income of $36.2 million or $0.68 per share which was up 5% and 9%, respectively. The company reported an adjusted net income of $47.2 million or $0.92 per share compared with an adjusted net income of approximately $46.9 million or $0.88 per share in the fourth quarter of the previous year. Adjusted earnings exclude amortization, equity compensation, impairments of long-lived assets and onetime events. In the fourth quarter, we had cash flow provided by operations of approximately $29 million and for the full year, cash flows from operations were $213.4 million. Let me take this time now to review a few of the financial assumptions we are using as we look forward to 2025 and beyond. We took a 3% price increase on BAQSIMI in the United States and we anticipate continued unit growth in the high single-digit range for this product. For Primatene MIST, we expect sales to grow in the high single digits this year as we continue to expand our physician sampling program. We are forecasting 2 product launches later this year from products on file at the FDA. Offsetting these growth trends will be sales declines due to increased competition for glucagon, epinephrine, phytonadione and enoxaparin. This will lead sales to be relatively flat in 2025 before returning to double-digit growth rates in 2026. We expect gross margins to be lower due to pricing pressures on glucagon, epinephrine and phytonadione which are higher-margin products. Additionally, the portion of our BAQSIMI sales made by Lilly in 2024 did not have cost of sales associated with them and these sales will be recorded by Amphastar this year, so they will have cost of sales, thus lowering our gross margin. Our selling and marketing expenses will increase slightly as a percentage of sales due to increased efforts related to BAQSIMI. Turning to research and development. We plan to ramp up spending on clinical trials and purchases of materials and supplies as we increased spending on our insulin portfolio, 2 inhalation candidates and our proprietary products. We also anticipate a significant increase in capital spending this year as we prepare to break ground on our expansion project that will significantly increase capacity at our Rancho Cucamonga facility as we look to commercialize major insulin and complex injectable opportunities. Spending on this major project began last year but will ramp up more significantly in 2025. We plan to finance this expansion with cash flow from operations. Additionally, we plan to utilize our strong cash position to continue to buy back our stock. I'll now turn the call back over to the operator for Q&A.

[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.