Amarin Corporation plc (AMRN) Q1 2026 Earnings Report, Transcript and Summary

Good day, ladies and gentlemen, and welcome to the Amarin Corporation's First Quarter 2026 Results Conference Call. [Operator Instructions] And please note, this conference is being recorded. I will now turn the conference over to your host, Mr. Devin Sullivan. Sir, you may begin.

Thank you for your time and attention this morning as we discuss Amarin's 2026 first quarter financial results. On the call today are Aaron Berg, President and Chief Executive Officer; and Pete Fishman, Chief Financial Officer. Other members of the senior management team will be available as needed during the Q&A session that will follow these prepared comments. Turning to today's agenda. Aaron will provide a state of the company, and Pete will walk through the numbers. Before we begin, I'd like to remind everyone that today's press release and related quarterly report on Form 10-Q are available on the Investor Relations section of the company's website, www.amarincorp.com, as will a replay of this call shortly after its completion. Please be aware that during this call, we may make certain statements related to our business that are deemed forward-looking statements under federal securities laws. These statements are not guarantees of future performance, but rather are subject to a variety of risks and uncertainties. Our actual results could differ materially from expectations reflected in any forward-looking statements. Additionally, we assume no obligation to update these statements as circumstances change. For a discussion of the material risks and important factors that could affect our actual results, please refer to our SEC filings, which are available either on our company website or the Securities and Exchange Commission's EDGAR system. With that said, I'd now like to turn the call over to Amarin's President and CEO, Aaron Berg. Aaron, please go ahead.

Thanks, Devin, and thank you all for joining us today. The momentum that started to build in late 2025 continued in the first quarter of 2026. Our results and cash generation in the quarter demonstrate our progress in advancing our new business model and expanding the global market for VASCEPA through our new and more efficient operating platform. We've substantially completed our previously announced global restructuring, and we remain on track to achieve the estimated $70 million in total operating expense savings by June 30, 2026. Our financial position continued to improve. Our cash balance of $308 million rose from year-end 2025. We reported a second consecutive quarter of positive cash flow and ended the quarter with no debt. 2026 will be the first full year in which we've employed our new and more efficient operating model comprised of 2 distinct but complementary businesses, a well-established and durable commercial business in the U.S. that continues to generate meaningful revenue and cash flow and a fully partnered commercial strategy for all other markets. I'll now provide some high-level commentary on each business. Our growth engine is comprised of a fully partnered international commercial strategy that's anchored by our exclusive license and supply agreement with Recordati. This relationship is focused in Europe, where we have IP protection through 2039 and covers 59 countries. European revenue in Q1 2026 rose significantly from Q4 2025, reflecting the promise of this partnership. As of March 31, 2026, Recordati had commenced sales of VAZKEPA in 10 countries, including a Q4 2025 launch in Italy. Overall, commercial momentum in Europe continues to build, driven by growth in in-market demand in key launch markets. We remain encouraged by these early performance trends. Lipid management in Europe is an increasingly important area of focus given the combination of aging populations, significant unmet need, evolving treatment standards and attractive long-term market potential. The potential for VAZKEPA to address the significant unmet need in cardiovascular disease beyond LDL lowering is similar to what we saw in the U.S. when we launched VASCEPA for cardiovascular risk reduction based on the strength of the REDUCE-IT trial. Recordati recognizes this as well and has prioritized the rollout of VAZKEPA in its active markets and those targeted for commercialization. We're also seeing continued growth in the rest of the world outside of Europe with our additional international partners, in China, Australia, Canada and the Middle East. Also, as we discussed on our fourth quarter call, we're preparing for early 2027 launches in South Korea and Singapore, are monitoring regulatory reviews of previously submitted applications in Thailand and the Philippines. And following the submission of Vietnam in Q1 2026, we're on track to submit a new filing in Malaysia in Q2 2026. Our U.S. team continues to operate the core business, which serves as a cash-generating base. As we've stated, while our U.S. franchise continues to see revenue declines due to the pressures of generic competition, VASCEPA remains the clear U.S. market leader across all available icosapent ethyl products more than 5 years after the introduction of a generic product. The overall IPE market based on third-party data rose by 3% in Q1 2026 compared to Q1 2025. Our share of the market rose to 48% at March 31, 2026, up from 42% in the same period last year. Most impressive is that VASCEPA branded prescriptions rose by 17% in Q1 2026 versus Q1 2025. The steps we've taken to rightsize our U.S. operations continue to allow our U.S. franchise to deliver efficient and profitable revenue. To that end, we expect to maintain our exclusives with key payers through the end of 2026, while also retaining coverage in our nonexclusive accounts. This remarkable achievement is a testament to the hard work of our team members, the reputation of our brand and the growing library of supporting scientific evidence that validates VASCEPA's ability to reduce cardiovascular events by 25% when added to a stat. In summary, both of our businesses are performing well. I ended last quarter's call by emphasizing the progress we've achieved to date and the important work that remains ahead. That message has not changed. What has changed is the building momentum behind our execution and the tangible progress we've delivered. We intend to continue to advance our organic growth initiatives and execute with a high level of financial and operational discipline. Additionally, we continue to collaborate closely with our exclusive adviser, Barclays, and exploring additional potential pathways to further enhance shareholder value. Now let me talk about some additional VASCEPA developments. In late 2025 and early 2026, we highlighted new post-hoc analysis from the REDUCE-IT study of statin-treated patients with elevated triglycerides and known cardiovascular disease or with diabetes and other risk factors. In these analyses, treatment with VASCEPA on top of statin therapy significantly lowered cardiovascular risk across a diverse range of patient subgroups in the REDUCE-IT study, including in patients with cardiovascular kidney metabolic or CKM syndrome, in patients with common risk factors like hypertension, diabetes, smoking and hypercholesterolemia as well as in patients at extreme or very high risk for cardiovascular events. Another analysis of REDUCE-IT showed that patients treated with VASCEPA on top of statin therapy experienced fewer total hospitalizations and fewer days lost due to hospitalizations and death during the study, providing additional insights on the effects of VASCEPA on patient-centered measures of total disease burden. Everything we do as a company is guided by our commitment to reduce cardiovascular disease as the leading cause of death. We're encouraged to see increasing momentum around the importance of addressing the numerous risks associated with elevated triglycerides, driven by the growing body of clinical evidence linking elevated levels to cardiovascular risk, independent of LDL and by evolving guidelines that formally integrate triglyceride treatments into cardiovascular risk assessment and treatment pathways. In March of this year, the American College of Cardiology, the American Heart Association and 9 other leading U.S. medical associations jointly issued an updated 2026 guideline for the management of lipids, including cholesterol and triglycerides. This updated guideline includes new recommendations based on high-quality evidence from major randomized controlled clinical trials that have been completed and published since the prior 2018 guideline, including our REDUCE-IT cardiovascular outcome study in VASCEPA. Within this updated ACC/AHA clinical treatment guideline, icosapent ethyl is positioned as the only primary triglyceride-lowering medication that reduces cardiovascular event risk in combination with statin therapy in individuals at high risk of cardiovascular disease with moderate triglyceride elevations after achieving sufficient LDL lowering. This reinforces that patients on statin therapy can continue to experience residual cardiovascular risk driven by elevated triglyceride levels and underscores the need for complementary therapeutic approaches beyond LDL-lowering therapy alone in these patients. Importantly, the guideline distinguishes therapies intended for pancreatitis prevention from those proven to reduce atherosclerotic cardiovascular disease events, reinforcing that cardiovascular outcomes, not biomarker changes alone must be the focus of and guide treatment decisions. For patients who remain at elevated cardiovascular risk despite optimized LDL therapy, the guideline supports the addition of evidence-based therapies specifically proven to reduce cardiovascular events such as icosapent ethyl. This position is consistent with guidance from other cardiovascular societies, including the 2025 ESC EAS dyslipidemias guideline focused update, which states that high-dose icosapent ethyl as in the REDUCE-IT trial should be considered for high-risk or very high-risk patients with elevated triglyceride levels despite statin therapy to lower cardiovascular events. Together, these guideline updates reflect growing global consensus around the importance of addressing residual cardiovascular risk beyond LDL lowering alone. Against this backdrop, and as we've highlighted previously, the introduction of promising new therapies is also elevating awareness of triglyceride-associated risk, catalyzing doctor-patient conversations, changes in behavior and in some cases, prescribed therapies. As a result, we believe VASCEPA is well positioned to benefit from the continued evolution of the lipid management landscape, specifically as it relates to the increasing attention on risks and unmet needs in patients with elevated triglycerides. I want to take a moment to explain why these developments may very well benefit sales of VASCEPA by strengthening its inclusion in the treatment flow from physician to formulary to patient. More than 500 peer-reviewed publications validate the science behind VASCEPA, including its ability to reduce major adverse cardiovascular events across diverse patient populations, and this groundbreaking therapy has been prescribed more than 30 million times by over 250,000 health care professionals. For new patients, treatment often begins with an established lower-cost therapy that has proven effectiveness with newly approved premium-priced, sometimes injectable therapies typically reserved for patients who need additional options or fail initial treatment. Coverage approval can reinforce this sequence through step edits requiring documentation that the preferred therapy was tried first before a costly alternative is authorized. VASCEPA taken orally is widely available, well established and supported by a clinically proven efficacy and safety profile. While the treatment landscape continues to evolve, our view remains straightforward. Therapies that are accessible today and backed by strong evidence should not be overlooked simply because newer options are gaining attention. Again, we applaud these new discoveries that may over time add to the array of options available to address this widespread health concern in patients at risk. I ended last quarter's call by emphasizing the progress we've achieved to date and the important work that remains ahead. That message has not changed. What has changed is the building momentum behind our execution and the tangible progress we've delivered. We intend to continue to advance our growth initiatives and execute with a high level of financial and operational discipline. With that, I'll now turn the call over to Pete to take us through the numbers.

Thanks, Aaron. Our results for the first quarter of 2026 reflected the continuing traction of our new business model and our global restructuring plan. Given the adoption of our new agreement with Recordati, I will, in some cases, also compare consecutive quarterly results, Q4 2025 to Q1 2026 to highlight recent progress. Total net revenue in Q1 2026 rose to $45.1 million from $42 million in last year's first quarter. By geography, U.S. was consistent with Q1 2025. While volume was higher due to regaining exclusive status with a PBM beginning in Q3 2025, this was offset by pricing based on annual changes for payers. First quarter product revenue in Europe was $4.9 million under our new partnered model as compared to $5.4 million in the first quarter of 2025 under our previous sales model. Notably, Q1 2026 revenue was generated at a significantly lower cost with improved operating margins when compared to first quarter of 2025. On a consecutive quarterly basis, Q1 2026 European revenue more than doubled, up 113% from Q4 2025 revenue of $2.3 million. European product revenue in the first quarter included $3 million of supply shipments to Recordati compared to $900,000 of such shipments in Q4 2025, reflecting initial stocking from the transition of our international commercial activities. With the transition now complete, going forward, Europe product revenue will come entirely from supply shipments to Recordati. Rest of World revenue in Q1 2026 was $2.8 million, whereas there were no supply shipments to our other partners in Q1 2025. As a reminder, our partnered model will result in revenue variability quarter-to-quarter, driven by the current scale of operations as well as the impact of launch timing, end market demand and the structure of individual partnership agreements. Cost of goods sold rose by $10.5 million or 62%, reflecting increased product volumes associated with regaining an exclusive PBM relationship in the U.S. and the effect of shipments to our rest of world commercial partners, both of which did not exist in last year's first quarter. Looking ahead, on a comparative quarterly basis, we expect our cost of goods sold to continue to be higher until Q3 2026, the anniversary of regaining this exclusive relationship. Our expense profile continues to reflect the success of global restructuring we commenced in mid-2025. In the first quarter, total operating expenses declined by 31% or $12.8 million to $29.1 million. Excluding the restructuring charge of $3.3 million, total operating expenses of $25.8 million declined by 38% from last year's first quarter. Q1 2026 operating expenses were relatively stable compared to Q4 2025 of $25.4 million. SG&A declined by 42% and represented 47% of total net sales compared to 87% of total net sales in last year's first quarter. R&D expenses were in line with our ongoing commitment to global regulatory support and to the science underlying our global branded product. As noted above, restructuring expenses were $3.3 million, down from $4.1 million in Q4 2025, bringing our total restructuring expense to $39.6 million. We incurred the majority of these restructuring expenses through March 31, 2026, with the remaining nominal expense to be recognized in Q2 2026. Our operating loss in the first quarter narrowed to $11.3 million from an operating loss of $16.8 million in last year's first quarter. Excluding restructuring charges, operating loss in Q1 2026 was $8 million. I also want to point out that despite the increase in cost of goods for the quarter, we were still able to drive down our total OpEx by 31% and excluding restructuring costs, cut our operating loss by more than 32%. I'll emphasize that it is early, but the Europe partnership model we adopted in 2025 is working. Turning to the balance sheet. We ended the quarter with cash and investments of $308 million, up from $303 million at year-end 2025, no debt and working capital of $450 million. We generated positive cash flow from operations of $6.4 million in the first quarter, the second consecutive quarter of positive cash flow. I would like to reiterate that we expect to generate positive cash flow for 2026. The business continues to evolve and improve, driven by key achievements realized over the past year. Under our new operating model, we rightsized the company to support both our U.S. business and our global partners in generating long-term international sales growth with an expense profile that is significantly lower than in prior years, reflecting the approximately $70 million in annualized savings to be achieved by the end of Q2 2026. Thank you again, and I now ask the operator to open the call to questions.

[Operator Instructions] Our first question is coming from Jessica Fye with JPMorgan.

I was hoping you could talk about the right way to think about the trend in U.S. net price over the remainder of the year. And then also related to the expectation for positive cash flow in 2026, can you talk about the degree to which you see that as sustainable beyond '26?

Sure. Good morning, and thanks for joining us this morning. Pete, why don't you cover both the questions, the net price and cash flow beyond '26. I know we have confidence going forward and touch on those.

Right. Thanks, Aaron, and thanks for the question. For the U.S. NSP, as you've seen in past years, the bulk of our year-over-year change occurs in Q1. And as we look forward to the rest of the year, we'd expect the NSP volumes to be relatively consistent. As we've said in the past, this is driven by our exclusive contracts. We expect to keep them through the rest of 2026. However, if there are changes, that would have an impact there. For the cash flow expectations beyond 2026, we are confident that as we've turned into a cash flow positive position that, that will continue into the future. But that -- again, that is driven by how we retain those exclusive contracts. But we feel confident that we will continue this trend going forward.

Great. And can I ask just a couple of follow-ups on the expense side, and I appreciate the commentary you gave on the COGS trend. So I guess maybe the other side of that is just like the gross margin percentage over the remainder of the year that be kind of stable? Is that going to be a little lumpy depending on supply shipments, is that a good way to think about that? And then on SG&A, sort of if we exclude the restructuring charges, is that a good run rate from here? And I know you mentioned restructuring expense would be kind of nominal in 2Q. Does nominal mean a similar size to 1Q or is that something different?

Yes. So starting on the COGS, as mentioned, a piece of that is the -- regaining that exclusive. So as you look into Q2, that will have an impact on the comparative for our COGS amount. And you're right on overall COGS and gross margin. It will be in part dependent on the supply shipments to our partners. As you know, in that partnership model, it does have a different margin point than the U.S. business and will have an impact in that. And you saw that again in this quarter as we had greater supply shipments compared to Q1 of 2025 and saw that lower margin percentage compared to that comparative year. On the SG&A side, excluding the restructuring, yes, this is a good way to look at that ongoing run rate. We'll continue to have the remainder savings as we've talked about in the past, but this is a good way to look at that run rate going forward. And finally, as far as the restructuring, you should look at that as a pretty nominal amount compared to past quarters and would not be at the same levels that you saw in the Q1 of the $3 million. It will be lower than that.

Our next question is coming from Paul Choi with Goldman Sachs.

I know it's early days since the most recent guidelines were issued. But Aaron, can you maybe just comment on physician feedback and any change in thought processes with regard to utilizing VASCEPA in light of the guideline changes? And then I have a follow-up as well.

Sure. So the guidelines, and it's also combined with news we've had over the last -- really over the last year, which saw -- the fibrate change. As you'll recall, we've spoken about, Paul, previously, where the label change and the emphasis on the fact that fibrates do not provide cardiovascular risk reduction yet. They're widely used in combination with statin for cardiovascular risk reduction. So that's one thing. That was also noted in the guidelines. And then this increasing focus around triglycerides, patients with elevated triglycerides and the risks of those patients. And as you know, there's a significantly increasing focus, and that also is noted in the guidelines. So qualitatively, what we're seeing from all of this and what we're hearing is very positive. Right now, it's qualitative. It will take time as these guidelines do and as news does for it to actually impact growth. And there are a number of dynamics that are related to all of these that are impacting growth, in particular, also, as we've noted previously, now with some of these newer triglyceride-lowering agents, these very good agents for FCS and severely high triglycerides, a lot of the payers are stepping them through existing triglyceride-lowering drugs, proven effective approved drugs like VASCEPA. So that will also wind at our back a little bit. So it will take time for all these to play out. Hard to quantify exactly what it will be, but it's all very timely. It's all happening at once, and it's very positive. I've got Steve Ketchum here with me as well. And Steve can speak to the guidelines and what the scientific community is saying about the impact as well.

Yes. Thanks, Aaron. Yes, we do see, Paul, these updated guidelines, both in the U.S. from the American College of Cardiology, American Heart Association, that were issued in March 2026. And of course, they're also consistent with the European equivalents that were issued last August. And although our REDUCE-IT results have been published back in 2018, 2019 time frame, that's when the prior version of this guideline, this dyslipidemia guideline was released, and it had not yet incorporated the REDUCE-IT results in other landmark cardiovascular outcomes trials such as those that showed that fibrates did not add any benefit on top of statin therapy. So we see these, as Aaron mentioned, as important, timely and major updates that position icosapent ethyl as an important consideration for patients with elevated triglycerides and that cardiovascular risk. So we see it as an exciting development.

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Yes. My follow-up is, as you transition to consistent cash flow profitability over the coming quarters, just with the stock price where it is, can you maybe just provide your -- maybe your high-level thoughts or maybe the Board's thoughts on -- in the future, returning some of this cash to shareholders as it starts to accumulate either in one form or another possibly?

Sure. That's a topic we talk about on a regular basis. As we've mentioned previously, we have -- we've been working with Barclays as our exclusive adviser and looking at strategic opportunities to capitalize on the value of the company. We feel like we've put the company on very sure footing, cash flow positive moving forward and sitting on that cash. But clearly, there are some things we can do to extract value. What shape or form that is yet to be determined because we're not in any type of desperate situation. We are being opportunistic, and we're focused on value for shareholders. In that context, cash -- buyback, cash back to shareholders, of some sort is a concept that is being discussed and could possibly happen at the right time. But we're thinking more holistically, strategically about the total value of the company. And when we have something tangible to report, we'll certainly do so.

Our next question is coming from Michael Ahn with Leerink Partners.

This is Michael on for Roanna Ruiz at Leerink Partners. I have two questions today. The first one is, do you have any update on your strategy around launching an authorized generic and what would trigger that decision? And the second question is, what's the underlying growth demand in the rest of the world market? And are there any milestone payments from rest of the world market that you're expecting in 2026?

Michael, so regarding the authorized generic, we've been -- we've done very well maintaining our branded business profitably in the U.S. We're incredibly efficient, maintaining the lion's share of the IPE category, and we're doing so with the strategy that we implemented a number of years ago, which is focusing on payers and the exclusives. That's proven to be very beneficial. And given that we've been able to maintain the exclusives and we believe we're maintaining those exclusives at least through 2026, then we don't believe that it's in our best interest to launch an authorized generic at this time, even though we're ready to do so when the opportunity arises. Once we find we can't compete any longer with this strategy, then that would be the opportunity to launch an authorized generic. But we've said this over the last couple of years, and being prepared to do so, but the strategy has paid off. We've been very patient. We haven't overreacted to the market, and that's turned out to be a very wise approach given how our financial results are and the revenue we're generating in the U.S. by investing very little in the U.S. So that's where we are with the AG. Once we feel the market dynamics turn, then we'll certainly do so. We see that as an opportunity to generate revenue, generate cash into perpetuity, frankly, as long as there's an IPE category and we have an authorized generic that can be distributed. Regarding growth in rest of the world and milestone payments, I'll let Pete address what's going on there and tied to into those partnership agreements.

Thanks, Aaron. We have been pleased with the end market demand growth within each of the regions and our partners. We have seen that consistent growth throughout. It is early stages in most of these markets. So we'll continue to monitor that, and we have been working very closely with each of our partners to support them in that growth. As far as the milestone payments go, we haven't been providing specific guidance around those growth. And there are milestones, as we've talked about with Recordati, for example, based off of in-market sales for them that will trigger milestones. But at this time, haven't been providing specific guidance on that outside of just that we've been pleased with what -- with each of our partners and what they've been able to accomplish to date.

And we're at the early stages, too, right? I mean it's -- again, as you said, it's kind of the tale of two companies. The U.S. is at one end of the life cycle. But in so many of these other regions, we're just getting going. And we've got very good partners. They've made VASCEPA/VAZKEPA a priority. We're really fortunate to have these partners, and our job is simply to execute and support them, but we look forward to what they can do, and they're certainly committed.

As we have no further questions in the queue at this time, this will conclude our question-and-answer session. And I would like to turn the call back over to Mr. Berg for any closing remarks.

I'd just like to thank everyone for participating today. I hope that we've been able to communicate the progress that we've made and our confidence about Amarin moving forward. We look forward to keeping you updated about our progress. And again, thank you for the continued interest in Amarin. Have a good day.

Thank you. Ladies and gentlemen, this concludes today's call, and you may disconnect your lines at this time. And we thank you for your participation.