Amarin Corporation plc

Welcome to Ameren Corporation's conference call to discuss its third quarter 2025 financial results. I would like to turn the conference call over to Bob Burrows, Investor Relations for Ameren.

Good morning. Again, I'm Bob Burrows, Ameren's investor relations contact. For those that don't know me, for nearly 30 years, I've served as an in-house investor relations officer at various public companies. And I've been a consultant for the Ameren team since August of 2024. Thank you for your time and attention this morning as we discuss Ameren's third quarter of 2025 financial results. Joining me with prepared comments 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. In terms of reporting housekeeping, please take note of the following. Today's press release and related quarterly report on Form 10Q are all available on the Investor Relations portion of the company website. An archive of this call will be posted on the Investor Relations portion of the company website shortly after the call. And finally, please be aware 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 forwarding statements. Additionally, we assume no obligation to update these statements as circumstances change. For 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. And with that, I'd like to turn the call over to Ameren's President and CEO, Aaron Berg. Aaron? Thank you, Bob. Good morning, everyone, and thank you for joining us. My comments today will focus on three themes. What we've done to get to this point, how the business is operating today, and most importantly, where we're going and why it's compelling as an opportunity for all our stakeholders. First, a recap of the series of critical strategic steps we've taken to solidify our core business and position us for the future. With the announced partnership with Record Adi in June of this year, we transitioned to a fully partnered commercial model across international XUS markets. We're now focused on leveraging a global syndicate of seven reputable and well-established partners with significant geographic expertise, covering a total of close to 100 markets worldwide. What's particularly exciting is the fact that we're still early in the lifecycle in many countries, especially key European markets, where Vescapa benefits from extended patent protection until 2039, and there remains significant untapped potential for high-risk cardiovascular disease patients. Critically, the long-term partnership for the European business enables us to capitalize on the capabilities and synergies of Recordati in Europe to efficiently generate revenue and build on the great foundation our team built over the past several years. This was the right step at an opportune time with a very strong partner and the culmination of a series of strategic moves that solidified our business foundation while also enabling the potential for a more accelerated expansion of the product to more patients. All of this has been done in direct alignment with our mission of doing all we can to reduce the cardiovascular disease burden for patients and communities around the world. In concert with partnering the European business, we took the painful but necessary step to implement an organizational restructuring that has resulted in right-sizing our operating footprint globally. As discussed previously, we look to realize aggregate OPEC savings of $70 million over the next year, the impact of which has begun to flow through in this latest reporting period, and we're now better positioned for the next phase of growth and value creation. As of today, the European transition with Recordati has progressed exceptionally well. During the quarter, the Ameren and Recordati teams completed the knowledge transfer and established working connections with all in-market country teams, resulting in what has been a very smooth handoff. We anticipate Recordati to be fully managing European commercialization and promotion in all launch countries by the end of 2025. Overall, since the signing of the Recordati partnership, momentum has been sustained throughout the commercial transition as both volume and demand continue to grow across all commercialized European markets. We remain extremely confident in Recordati's ability over time to accelerate the depth and reach of ASCEPA for patients across Europe who are at risk for cardiovascular events. And we look forward to providing a further update on this front when we report the year-end 2025 results in early 2026. Pivoting to the opportunities across the rest of the world markets, we're continuing to actively support our partners' ongoing initiatives to expand patient access in these key additional growth geographies. Our partners are focused on driving patient uptake, by highlighting the tremendous value and potential for the SEPA in their respective markets and continue to make progress in commercialization and regulatory processes locally. Overall, success of our partners in both Europe and the rest of the world is fundamental to our global strategy of making the SEPA available to the millions of patients in need of cardiovascular risk reduction today. All our partners are leveraging their established infrastructure, capabilities, people, and passion to drive growth in our core franchise and to maximize its global reach. The pieces are now firmly in place, and we're excited by what the future will bring as these initiatives continue to progress. Turning to the U.S. business, we continue to manage and maintain this important commercial arm of the company. To the end of the quarter, Masipa stood at greater than 50% share of the IPE market, a remarkable achievement five years since the first generic product was introduced. In addition, we retained the major exclusive accounts, and as of July 1st, we regained exclusive status with a large national pharmacy benefit manager. As expected, this shift positively impacted volumes with minimal revenue impact. Based on the current market dynamics and feedback from key accounts, we're confident we will retain our major exclusives at least to the end of 2025. Since our exclusive accounts deliver the majority of our US product sales, we continue to work with payers to keep the SEPA affordable and provide patient access to the sole branded product within a diverse competitive market. Overall, We have consistently and aggressively pursued a strategy to remain competitive. We'll continue to take the right steps to manage the Vesepa brand moving forward, always with patients at the center of our strategy. Our focus remains on maximizing both the clinical impact of Vesepa for cardiovascular risk reduction and the financial strength of the U.S. business. From a scientific perspective, We continue to demonstrate our commitment to advancing cardiovascular care through a sustained and consistent presence at major medical meetings. This quarter, we not only supported partners in their own efforts around medical meetings, but also marked our strongest presence ever at the European Society of Cardiology 2025 conference. At ESC 2025, we had five accepted abstracts presented, and importantly, that SCEPA was again included in a 2025 ESC EAS dyslipidemia guideline-focused update, which reaffirmed high-dose icosaminethyl as a class 2A recommended therapy for high-risk or very high-risk patients based on the landmark reduce-it results. These insights are a direct result of our sustained commitment to generate meaningful data that informs clinical practice and supports our mission to address residual cardiovascular risk, a persistent threat to millions of patients worldwide. Cardiovascular disease remains the leading cause of death globally, and far too many high-risk patients remain vulnerable despite being treated with standard of care therapies. Given this reality, it's well understood that addressing cardiovascular disease is a complex challenge, one that many stakeholders across the healthcare ecosystem are working to solve. And as a result, the science related to heart disease is continually evolving. As a case in point, and as we commented on Monday of this week, we're deeply appreciative of the FDA's recent action to revise the labeling of fetal fibrates prompted by the Healthy Women's Citizens Petitions. These drugs have been used for decades under the belief they reduce major cardiovascular events, leaving patients thinking they're receiving appropriate care. Yet multiple large cardiovascular outcome trials have shown that fibrates and another related fibrate compound fail to reduce those events, even in high-risk patients on background statin therapy. The updated labeling now includes a clear statement on the lack of cardiovascular benefit, relevant safety data, and a refined indication as follows. Well, phenofibrate did not reduce cardiovascular disease morbidity or mortality in two large randomized controlled trials of patients with type 2 diabetes mellitus. Risk for rhabdomyolysis is increased when fibrates are co-administered with a statin. Avoid concomitant use unless the benefit of further alterations in triglyceride levels is likely to outweigh the increased risk of this drug combination. Phenofibrates are now indicated for the reduction in elevated LDL-C in adults with primary hyperlinkedemia when use of recommended LDL-C low-rank therapy is not possible." This FDA action is crucial. because fibrates remain widely prescribed with more than half of fibrate patients also on statins. The FDA concurs that there is no scientific justification for suggesting that statin-treated patients may benefit from the addition of phenofibrate. The FDA also supports updating phenofibrate labeling to reflect findings from the prominent cardiovascular outcomes trial, which evaluated another fibrate compound. This revision marks a critical step toward lasting reform in prescribing practices and a renewed opportunity to ensure patients receive the care they require by shifting clinical practice away from treatments that lack cardiovascular benefit and toward effective and safe therapies backed by robust outcomes data. As we've long advocated, cardiovascular risk reduction must be rooted in proven outcomes, not solely on improving biomarkers, such as reducing triglycerides in patients with elevated triglycerides. The FDA's decision reinforces this principle, helping to correct longstanding risk perceptions and guiding healthcare providers, payers, and patients toward evidence-based care that truly provides cardiovascular protection. Our data continues to validate the role of the SEPA in reducing major adverse cardiovascular events across diverse patient subgroups. These findings not only strengthen the scientific foundation, but also underscore the urgency of delivering proven therapy to those who need protection now. With that, let me finish with where this all leads and what we see for the company going forward. Looking ahead, we see significant untapped potential for the company. With patients at the core of our mission, Vesipa stands as a globally differentiated and complementary asset, clinically proven to reduce cardiovascular risk, and uniquely positioned to unlock significant value across underpenetrated markets. The partnership with Recordati initiated an entirely new phase for the company, as we've now transitioned to a fully partnered commercial model across all international markets. Our syndicate of seven partners across the globe are rapidly pursuing the expansion of the market for Vesipa. We've continued to efficiently generate Vesipa revenue in the US, successfully defended the brand in the US via competitive pricing, and expect that market to remain a significant contributor of cash and profit to the company moving forward. Vesipa continues to garner strong support globally within the scientific community particularly among key opinion leaders, clinicians, and other influencers around the safety, efficacy, and unique mechanism of action of IPE and EPA. And we're just getting started on realizing the full benefit of our newly right-sized operating footprint, including expanded operating margins and an accelerated path to positive free cash flow over the next year. In summary, we're confident in the strategic actions we've already taken, optimistic about the potential and future of our global business, and actively working to identify value-building opportunities that capitalize on and leverage all our strengths. As always, we look forward to reporting on our future progress. And with that, I'll now turn the call over to Pete to take us to a review of the numbers. Pete.

Thank you, Aaron. At the end of the third quarter of 2025, our business continues to demonstrate financial discipline with operating margin and cash flow trends positioned for steady improvement. The third quarter marked the first full quarter following the record ID partnership agreement as we transitioned to a fully partnered model outside of the U.S. The results offer early indications that the strategic decisions implemented have positioned the company to enhance shareholder value, and we are optimistic about the path forward. I will now turn to the financial results for the most recent reporting period. Total net revenue was $49.7 million, an increase of $7.4 million, or 17% versus the prior year period, primarily reflecting the impact of higher U.S. sales. Net product revenue was 48.6 million, an increase of 6.7 million, or 16%. For the U.S. business, net product revenue was 40.9 million, an increase of 10.3 million, or 34%, primarily driven by an increase in net selling price from a change in customer mix and an increase in volume by regaining exclusive status with a large PBM during the quarter. As of Q3 2025, we maintained a majority share of over 50% of the IPE market, further validating the resilience of our BESIPA franchise, now five years post-generic entry. A track record we will continue to manage, primarily through our commitment to competitive pricing. For the Europe business, as Aaron mentioned earlier, the transition of our commercialization operations to Recordati is progressing and remains on track for completion by year end. Q3 2025 was the first reporting period with the Recordati licensing agreement in full effect. Product revenue is $4.1 million, consistent with the prior year period. Current period product revenue includes $1.7 million in supply shipments to Recordati and reflects the shift in the European business model. We are pleased by the continued in-market demand growth across all launch geographies, particularly as we navigate this transition phase with Record On. It's important to note that by moving to a partnering model consistent with our rest of the world business, product revenue will be variable quarter to quarter, reflecting the current scale of operations, as well as the impact of launch timing, in-market demand, and the structure of individual partnership agreements. For the rest of world business, product revenue was $3.6 million, a decline from the prior year, but consistent with the second quarter of 2025. Licensing and royalty revenue was $1.1 million, an increase of $0.7 million, reflecting our partners' continuing to drive in market demand. We are encouraged by the potential of these international markets and remain committed to collaborating closely with our partners to unlock the full potential and reach of these evolving markets while we continue to efficiently compete on volume and price in the U.S. We look forward to sharing continued progress in the quarters ahead. Turning to expenses, during Q3 2025, we began to realize the savings as part of our global restructuring that was announced in conjunction with the Recordati partnership. Specifically, SG&A was $19.7 million, a reduction of $17.2 million, or 47% over the prior year period. This begins to give an indication of our right-sized operating footprint. R&D expense was $4.2 million, in line with our ongoing commitment to global regulatory support and the science underlying our global branded product franchise. We expect these cost savings to continue to flow through the income statement in future quarters. Restructuring expense was $9.4 million, bringing our total cost to date to $32.2 million, of which $17.2 million has been paid as of September 30, 2025. We expect these costs to trend lower going forward as we complete the operational transition. As a result, operating loss was $11.1 million, which is 14.1 million or 56% lower than Q3 2024, a clear indication of a path to more efficient and cost-appropriate operations. In addition, Q3 2025 operating margin was negative 22%, a substantial improvement from the negative 60% margin in the prior year period. Now turning to the balance sheet, we ended the quarter with $286.6 million in cash and investments no debt, and working capital, $446 million, supporting our confidence in the current stability of our capital structure as we move forward with our new business model in Europe. We remain focused on prudent cash deployment to support growth opportunities and drive shareholder value. To wrap up, our Q3 2025 results reflect the combination of elements, the first full quarter under the terms of the Record Audi Agreement, a new norm in terms of ongoing OpEx levels, and the continued resilience of our U.S. business. These factors, along with growing in-market momentum across our international markets, have positioned the company on solid financial footing, both now and for the future. We remain sufficiently capitalized to finance our operations while we continue to take steps to progress on an accelerated path to positive free cash flow, which we anticipate achieving in 2026. I'll now turn it over to the operator to begin the question and answer session. Operator?

Certainly. At this time, we will 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 would 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. Once again, that is star one to ask a question. One moment, please, while we poll for questions.

Your first question for today is from Jessica Fye with JP Morgan.

Hey guys, good morning. Thanks for taking your questions. Two from us, or maybe three. First, how should we think about the U.S. net price trajectory for the back half of 25 and ideally into 26, if you can comment there? Second, any framework for how we should think about future milestone payments from Recordati? Can you talk about what could trigger those payments? And then lastly, Thinking about gross margin over time, I'm curious how you would advise us to think about the trajectory over the next few years in light of what seems like it could be a mixed shift within product sales from U.S. sales towards a higher proportion of, like, supply sales to partners, if that makes sense. Thank you.

Thanks, Jess. Thanks for joining us. Thanks for the questions.

I'll address the milestone question first, and I'll turn it over to Pete Fishman to talk about the net price trajectory as well as gross margin over time. As far as the milestones, the structure of the deal is based on sales performance. So as they start off at $100 million in sales, and as it goes up from there, as Recordati surpasses that, then that's where we trigger the milestone payments. So they're focused on Vescapa as a priority. They are moving very, very quickly. It'll take some time for the growth, but we're confident. It's a long-term partnership, so we have confidence in their ability to drive sales and hopefully achieve those milestones. Pete, do you want to touch on that price as well, the gross margin?

Sure. Thanks, Aaron. On the U.S. side for the net price, as we look to the remainder of 2025, we do anticipate that it will be relatively consistent from what you've seen over the last few quarters of this year. As we look into 2026, we're still in early negotiations or conversations with the payers for our exclusives to determine what our rebate percentages will be. But if you look historically, you have seen a bit of a decline in the beginning of the year going into the next year based off of those contracts and agreements with our exclusives. In terms of the gross margin percentages, you're right, as we move to more of a partnered model, you're going to see a decline in the gross margin percentages going forward. That said, with a decline in our operating expenses moving forward, too, based off of this model, when we look at operating margin moving forward, we will start to see the benefit from these partnership agreements and lower operating expense.

Thank you. Thanks, Jess.

Your next question is from Mazi Ali Muhammad with Lyric.

Hey everyone. Good morning. Um, it's amazing on for honoraries. Um, just two from us. Um, I guess first, you know, so, so Europe sales dips slightly this quarter because of the transition record. It makes sense, but, but could you outline the cadence of expected royalties or milestones from record already going forward? And whether the, I guess you just answered that. So really, so most on this question, with the 4Q25, does that mark like the trough of European contribution as the transition normalizes? And then a second question for me is, you know, with the recent phenofibrate update, like how do we think about the split or kind of the use of phenofibrate in the U.S. versus rest of world? And how do you think about this update kind of impacting rest of world practices where there may be more phenofibrate use? Could this be like an added tailwind in those markets? Thank you.

Thanks, Basie. Thanks for joining us, and thanks for the questions.

As far as the trough, could you just clarify the European question?

When you say Q4 and the trough, could you provide a little bit more clarity on that so we answer it the right way? Sure.

I guess I was getting at, like, do we think that in terms of the transition period and then some of the costs or the added kind of added expenses that would come with the transition period, do we expect that kind of that's now going to be at the end of the year and then starting, you know, 26 and onwards, we expect that all the kind of issues or costs that were associated with that would be over and now we would just be moving forward is kind of what I meant with that first part, if that makes sense.

Yeah. Okay. So, Pete, do you want to talk about the restructuring costs? We had Q3 and then into Q4 and

Yeah, sure. So as you've seen over the last couple of quarters, we have had the restructuring costs. It has trended downwards. We do anticipate additional charges within Q4 at a lower level. And then moving into next year, seeing those restructuring charges and continuing to see that benefit on operating side of supply. the expense side. As a reminder, what we talked about in our initial release are restructuring charges in the range of $30 million to $37 million, and we are within that range and expect by the end of the year to remain within that range. And as we also look forward, the transition completing, you'll start to see that normalization of revenue more in line with our typical partnership model of rest of the world with that variability on the supply side, but continued royalty sharing as well.

Regarding the question on phenofibrate, First, I'll talk about the U.S. and why it matters and then how that works or what our perspective is versus ex-U.S. So the issue in the U.S. is fibrates are used extensively in combination with statins for reducing cardiovascular risk reduction and have been used as such for decades. There are more prescriptions written for fibrates in combination with statins than total IPE, that's the CEPA plus generics combined. Yet, the data continues to show that there is not a reduction in cardiovascular events when you add fibrates to statins. Yet, there is an increase in the risks, and certainly on the safety side, as noted in the label. FDA has reacted to that. Science continually evolves. It's good to see FDA step up and acknowledge that because there are a lot of patients at risk when it comes to that. So how that will work out for the U.S. and whether or not that drives the IPE category depends on whether or not there is change by providers and change by payers. They are cheap drugs and there's a lot of apathy around it. It's a habit that's been instilled But the science has evolved, and hopefully all of those stakeholders will respond to how the science has evolved, and they can do better for patients. And patients need to have better therapies. And frankly, one of those therapies is vasepa, because we have the cardiovascular outcomes and the FDA indication as such. In terms of the rest of the world, Europe and the rest of the world, there is extensive fibrate use everywhere. There are some countries where it's more than others. They're used primarily with the hope that they prevent cardiovascular events. Even though they're triglyceride-lowering drugs, which is why they're a direct competitor to IPE, to Vascepa in Europe, bottom line is they're used in a way that really should change, given that the science has evolved. And the hope is that while the label change from FDA is U.S.-centric, that this The science has recognized the rationale for changing that is not a U.S. issue. That's a global issue. The fibroids don't work to reduce cardiovascular events anywhere, and hopefully that's something that will make a difference in the business. If there's change, then those patients that have elevated triglycerides and are on statins, have controlled LDLs, fit the reducing criteria, fit our label, fit our reimbursement in these countries, then the option should be the SEPA. And hopefully the providers and the payers, where reimbursement is, and for that matter, where we have regulatory activity going on for future approvals, hopefully they all respond to that and we see the benefit for years to come.

Thank you so much. That makes a lot of sense. Thank you.

Your next question for today is from Paul Choi with Goldman Sachs.

Good morning, this is Daniel on for Paul. Thanks for taking our question. So we're curious about like why is the rest of the world revenue declining by half compared to 3Q2034? If you could provide some colors on that.

Thank you very much. Pete, do you want to comment on that? Sure.

So as we've talked about in the past, The rest of the world revenue in this partnership model is based off of supply shipments to our partners. There is going to be variability within that based off of the in-market demand, the timing of the launches, and other factors. And leading into last year, there was additional supply purchases as a result of launch in in-market with our different partners. we've seen kind of more of a steady state where there hasn't been any of those larger launches in this quarter, and we expect that variability to continue as we look forward in each of these markets.

Thank you.

We have reached the end of the question and answer session, and I will now turn the call over to Aaron Berg for closing remarks.

Thank you. Thank you to everyone for joining us today. Thank you for the questions, and enjoy the rest of your day.

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