Amarin Corporation plc

Good morning and welcome to Ameren Corporation's conference call to discuss its second quarter 2026 financial results. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I would now like to turn the conference call over to Devin Sullivan Investor Relations for Ameren.

Thank you for your time and attention this morning as we discuss Ameren's 2026 second quarter financial results. On the call today are Aaron Berg, President and Chief Executive Officer, Steve Ketchum, President R&D and Chief Scientific Officer, and Pete Fishman, Chief Financial Officer. Other members of the senior management team will be available as needed during a Q&A session that will follow these prepared comments. Aaron will provide a state of the company. Steve will provide an update on recent medical and regulatory activities. And Pete will walk us through the numbers. Before we begin, I'd like to remind everyone that today's press release and related quarterly report on Form 10Q will be available on the investor relations section of the company's website. www.amroncorp.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 Ameren's President and CEO Aaron Berg Aaron, please go ahead.

Thanks, Devin, and thank you all for joining us today. Q2 2026 marked an inflection point for Ameren, highlighting the one year anniversary of our dual commercial strategy that combines continued execution of our U.S. business with a fully partnered international commercial platform. The successful implementation of these actions has resulted in a scalable business model while defining a clear path towards sustainable growth and profitability. We're seeing a promising early stage international sales trajectory in a number of markets where there remains significant unmet need and long-term potential for VSCEPA while preserving a leading US presence for VSCEPA supported by a financial foundation that includes a growing cash position and no debt. Our restructuring activities are now complete, resulting in a significantly lower cost base. This refined organizational structure and expense framework will enhance our ability to efficiently execute our long term growth strategy. As you may have noticed in our press release, were now able to provide an outlook for certain key metrics for full year 2026, reflecting the clarity afforded by our new operating model and the strong partnerships that make up its foundation. This underscores how far the business has progressed in the past year while validating our global go-to-market initiatives and reinforcing the continued outstanding execution of our talented, committed team. As of June 30th, 2026, the SEPA was commercially available in 22 countries via both our fully partnered international commercial strategy and company managed US presence. Our accelerating international growth is being driven primarily by our exclusive license and supply agreement with Record Audi, which covers 59 countries across Europe, as well as our six other commercial partnerships in the rest of the world. that cover regions including Canada, China, Israel, the Middle East, Asia, Australia, and New Zealand. Across this combined global partner network, in-market demand for Vesipa rose by 59% in cumulative year-over-year volume as of June 30th compared to the same period last year. As of the end of Q2, Beskepa is commercialized in 11 countries in Europe, including a recent launch in Romania, and Recordati continues to invest meaningfully with pricing, reimbursement, market access, and adoption, advancing in numerous additional countries across the licensed territory. Under Recordati's leadership, Beskepa is in an early but promising stage of commercialization in Europe's large cardiovascular market, where the disease affects an estimated 62 million people and carries an annual economic burden of approximately 282 billion euro across the European Union. In-market demand in Europe from Escefa under the Recordati partnership rose by 69% in Q2 2026 from Q2 2025. Spain and the UK, though early, are leading commercial adoption providing a strong foundation for future growth as pricing, reimbursement, and commercialization efforts continue across the broader territory. In Italy, where Recordati is one of the country's most established pharmaceutical commercial organizations, Vescappa launched with significant commercial support and has demonstrated strong early uptake. Vaskepa is positioned by Recordati as a priority brand in its cardiovascular portfolio, backed by an expanded cardiovascular commercial infrastructure across Europe, including dedicated field representatives, medical science liaisons, and marketing investment. In its 2025 annual report, Recordati referred to Vaskepa as a best-in-class treatment option that complements its existing cardiovascular portfolio is supported by a robust clinical data package and makes a meaningful impact for cardiovascular patients with residual cardiovascular risk. While driving utilization in launch markets, Recordati is actively progressing pricing, reimbursement, and market access across additional territories, building a meaningful base for long-term royalty and milestone growth as additional countries come online. While very early, the commercial performance since the June 2025 licensing transaction is encouraging in that Recordati's established cardiovascular infrastructure, broader geographic footprint, and tremendous execution have unlocked substantially greater value from Vescapa than would have otherwise been possible had Ameren continued Vescapa commercialization throughout Europe alone. The commercial momentum generated by Recordati thus far materially exceeds historical European growth rates achieved by Ameren prior to the licensing transaction. As a reminder, European markets each follow their own regulatory process for pricing, reimbursement, and market access, so commercial launches can progress at different speeds and under varying requirements across countries despite an overarching EU framework. In the U.S., our core business continues to serve as a highly efficient cash generating base with FACIPA retaining a leading position in the eicosapent ethyl market despite ongoing generic pressure. We continue to expect to maintain our exclusives with key payers through the end of 2026. The overall US IPE market, based on third party data, rose by 3% in Q2 2026 compared to Q2 2025. The SEPA share of the market rose to 48% as of June 30th, 2026, up from 43% in the same period last year. Despite continued pricing pressure, the SEPA branded prescriptions increased 14% year over year in the second quarter of 2026, reflecting continued commercial execution in the competitive market. We expect US volumes to remain stable through the end of 2026. Outside of Europe and the US, we continue to support our partners in advancing regulatory submissions in various other countries across Asia. We recently received approvals in Singapore and South Korea and look forward to the launches in these territories in 2027. As our international footprint continues to expand, the work of our medical affairs, regulatory, and R&D teams becomes increasingly important. Beyond supporting IMRN's own scientific objectives, these teams provide critical expertise to our commercialization partners around the world to contribute to our joint success, helping them navigate local regulatory requirements continuing to contribute to an already robust library of scientific evidence supporting the benefits and unique attributes of icosapen ethyl, engage with key scientific leaders, support reimbursement discussions, and prepare for successful product launches. Through scientific exchange, Congress participation, publication support, medical education initiatives, and ongoing regulatory collaboration, These teams help ensure that our partners have access to the latest data and insights supporting the SEPA as they work to improve access for patients in their respective markets. To provide additional perspective on the scientific, medical, and regulatory activities supporting our global growth strategy, I'll now turn the call over to Steve Ketchum.

Steve? Thank you, Aaron. Supporting our global commercialization strategy is an experienced medical affairs Regulatory, Technical Operations, and R&D organization that works closely with our partners throughout the product lifecycle, from regulatory submissions and scientific exchange to market access and commercial launch. Together, these teams help advance the science behind VSIPA and VSCEPA while enabling successful regional commercialization across our global partner network. Our commitment extends well beyond supplying products. We believe sustained scientific leadership is one of the most important ways we create value for patients, healthcare providers, and our partners. More than seven years after the landmark REDUCE-IT results and more than six years after the US approval of the CIPA for cardiovascular risk reduction, we continue to invest in meaningful scientific research that expands our understanding of cardiovascular risk and reinforces the role of high-dose FACIPA in contemporary clinical practice. Beyond generating new evidence, our teams work closely with partners through publication initiatives, scientific congresses, key opinion leader engagement, launch planning, regulatory support and medical education, helping ensure they are equipped with the latest evidence to support successful commercialization and expand patient access across global markets. That commitment is reflected in a steady cadence of scientific advancements, guideline recognition, and partner-led educational initiatives that continue to strengthen the global evidence space for high-dose vasepa icospin ethyl. In May, We announced new data from a post hoc analysis of the REDUCE-IT trial that was presented at the European Atherosclerosis Society or EAS Congress in Athens, Greece. The analysis conducted in the REDUCE-IT placebo arm found that among statin treated patients with elevated triglycerides, risk-weighted apolipoprotein B or ApoB more effectively identified patients who remained at increased residual cardiovascular risk compared with traditional lipid biomarkers. These recent findings add to the body of evidence that many high-risk patients continue to face substantial residual cardiovascular risk despite statin therapy and highlight the potential value of more refined lipid metrics to better identify patients who may benefit from evidence-based treatment. Prior findings from REDUCE-IT have shown that Vazepa consistently reduced major adverse cardiovascular event risk across the spectrum of lipoprotein A levels, including in patients with elevated lipoprotein A, an increasingly recognized contributor to residual risk. These previously published findings suggest that any future benefits from emerging lipoprotein A lowering therapies may be complementary to the established cardiovascular risk reduction demonstrated with Faseepa. This growing body of evidence complements the continued recognition of high-dose icosphen ethyl and leading international treatment guidelines. Both the 2026 ACC AHA Multisociety Dyslipidemia Guideline and the more recently released ACC AHA Multisociety and the cardiovascular kidney metabolic syndrome guideline, formally recommend high dose of glycose and ethyl for appropriate high risk patients. Together with recommendations from more than 70 medical societies worldwide, these endorsements underscore the strength of the evidence supporting the CIPA and reinforce its important role in addressing residual cardiovascular risk. Looking ahead, We remain committed to advancing the science that supports patients, clinicians, and our commercialization partners. Early next month, we will support our Australian partner, CSL Securus, at the Cardiac Society of Australia and New Zealand, or CSANS, annual scientific meeting in Sydney. As one of the region's premier cardiovascular congresses, CSANS provides an important forum for scientific exchange and physician education. During the meeting, CSL Securus will sponsor a medical education session entitled Transforming Secondary Prevention After MI, Imaging Residual Risk and Targeting What Remains, featuring professors Peter Saltis and Adam Nelson, in addition to presenting a mini oral abstract entitled Benefits of Icosapent Ethyl in Patients with Prior Peripheral Artery Disease, Reducid PAD. We are proud to support these efforts as part of our broader commitment to advancing cardiovascular science and helping our partners educate clinicians with the latest evidence. Later in August, we will also participate in the European Society of Cardiology Congress in Munich. As one of the world's largest cardiovascular meetings, Bringing together more than 33,000 healthcare professionals from nearly 170 countries, ESC provides an important platform to share new scientific findings. We are pleased to have five scientific abstracts accepted, including multiple new reduced analyses and mechanistic data that continue to deepen our understanding of the clinical benefits of high-dose placebo. We also anticipate the release of the European cardiovascular kidney metabolic guideline during the ESC meeting, representing another important milestone for cardiovascular care and providing an additional opportunity to engage the global scientific and clinical community. Our continued investment in science reflects a simple belief. Strong clinical evidence drives better patient care while creating long-term commercial opportunity. Beyond supporting current commercialization efforts, we continue to evaluate cost-effective opportunities to further advance the science of icosaphen ethyl and explore potential future lifecycle management initiatives. While these efforts remain in the early stages and no development decisions have been made that are appropriate for public disclosure today, We believe disciplined scientific innovation remains an important component of long-term value creation. We will communicate developments when there are meaningful updates to share without setting unrealistic expectations. By continually expanding the evidence base and providing our partners with ongoing scientific, regulatory, technical, operational, and medical expertise, we are helping accelerate global access to the SEPA and the SCEPA support successful commercialization across international markets and ultimately improve cardiovascular outcomes for patients worldwide. With that overview of our scientific progress and partner support activities, I'll turn the call back to Aaron. Thanks, Steve.

Before turning things over to Pete, I want to emphasize that the story we've authored is functioning as intended, with each chapter of execution adding momentum that supports the next phase of growth. We continue to advance our organic growth initiatives and execute with a high level of financial and operational discipline. Additionally, we continue to work closely with our exclusive financial advisor Barclays as we actively evaluate additional potential opportunities to enhance shareholder value. Our commitment to patient care remains the foundation of everything we do, shaping our strategy, guiding our decisions and directing our investments. With that, I'll now turn the call over to Pete to take us through the numbers.

Thanks, Aaron. As Aaron mentioned, the benefits of our dual sales model and now completed restructuring plan are becoming increasingly clear with execution against three key priorities. Advancing international growth through our partners, operating with a significantly lower cost base, and continuing to strengthen cash generation. In summary, European product revenue increased from Q1 2026 and total operating expenses excluding restructuring charges materially declined from Q2 2025. We also generated positive cash flows for the third consecutive quarter and improved our cash position by 12 million from year end 2025. Total net revenue in Q2 2026 was 42.2 million compared to $72.7 million in last year's second quarter, which included a $25 million upfront payment associated with the commencement of the Recordati transaction. Product revenue was $39.1 million compared to $46.6 million. By geography, U.S. product revenues declined to $32.2 million from $36.5 million in Q2 2025 driven by ongoing pricing pressure in the competitive generic market, partially offset by higher product volumes. Importantly, despite this pricing pressure, the US business remains profitable and continues to generate cash. Second quarter product revenue in Europe was 5.4 million under our new corporate model and consisted entirely of supply shipments to RecordEye. This compared to 6.6 million in the second quarter of 2025 under our previous sales model. Lower revenue despite the increase in market demand of 69% reflected the transition to record high. Q2 2026 European revenue increased 11% from Q1 2026 and was up by 140% from Q4 2025. We're encouraged by this early momentum. The world's revenue in Q2 2026 was $1.4 million, down from $3.5 million in the prior year period, reflecting normal variances across multiple geographies as these respective markets continued to develop. Cost of goods sold in Q2 2026 rose 22% to $27.2 million from $22.4 million due to increased product volumes primarily associated with regaining an exclusive PBM relationship in the US beginning in Q3 2025. Lower operating expenses reflected the success of the now completed global restructuring which we commenced in mid 2025. The decrease was in line with the previously announced approximately 70 million in annual cost savings and established a more efficient operating expense baseline. Q2 2026 total operating expenses declined by 59% or $39.3 million to $27 million. Excluding the restructuring charge of $22.8 million in Q2 2025, total operating expenses decreased 38% from prior year period. We incurred no material restructuring charges in Q2 2026. Selling general and administrative expense for Q2 2026 was $22.2 million, a 43% decline from $38.7 million one year ago. R&D expenses were in line with our ongoing commitments and our partners' ongoing expansion into new markets. R&D reflects our commitment to global regulatory support and to the science underlying our global branded product. Our operating loss in the second quarter narrowed to $12 million from an operating loss of $16 million in last year's second quarter. Despite the increase in cost of goods for the quarter, we narrowed our operating loss by 25%. Turning to the balance sheet, we ended the quarter with cash and investments of $314.6 million, up from $303 million at year end 2025 with no debt and working capital of $439 million. Importantly, we generated $7 million of positive cash flow from operations in the second quarter, our third consecutive quarter of positive cash flow, and we continue to expect positive cash flow for full year 2026. Given this stronger cash position and continued cash generation, I also wanted to briefly address our previously authorized share repurchase program. We recognize that many shareholders are eager for an update and we appreciate your continued interest. As we have discussed previously, the UK High Court approval obtained in connection with the authorization remains in effect through Q2, 2029. Since obtaining that approval in 2024, the business has evolved considerably. Today we are operating from a stronger financial position with improved cash generation. We understand our responsibility to deploy capital in a way that benefits shareholders. Capital deployment can take a number of forms and we will continue to evaluate our options carefully and provide updates if and when there are material developments. Disciplined inventory management remains a high operational priority and an important driver of cash flow and overall business health. As of June 30, 2026, inventory declined by $19.5 million from March 31, 2026 and by $31.8 million from December 31, 2025. This reflects our multi-year approach to purchasing API at the appropriate time, considering manufacturing lead times, supply continuity requirements, and evolving demand trends across our markets. This discipline allows us to support expected commercial demand while avoiding unnecessary working capital tied up in inventory. The business continues to strengthen supported by key milestones achieved over the past year. Under our new operating model, we are operating with a leaner cost structure, working capital discipline, and greater financial flexibility to support our US profitability and sustainable international growth through our partners. I now ask the operator to open the call to questions.

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. One moment please while we poll for questions. Your first question for today is from Paul Choi with Goldman Sachs.

Hi, good morning, and thanks for taking our questions. Aaron, first one is just on sort of the reimbursement landscape in Europe. Appreciate that it's country by country, but in terms of sort of the major markets, can you maybe give us an update on sort of what still needs to be done in the various key geographies in Europe? And my second question for Pete is just on cost of goods came in a little bit higher than I think the street had been modeling. Can you maybe just help us understand if this is sort of the sustainable rate that you're expecting, given volume growth that you're anticipating here on a go-forward basis? Thanks for taking our questions.

Hi, Paul. Thanks for the questions. Appreciate it. And thanks for joining us. Regarding Europe, and reimbursement. As you noted, it's a different pace and different rate across all the countries. So where we launched or now Recordati commercializing primarily UK, Spain, Portugal, as well as now getting off the ground in Italy. The reimbursement is there, always looking for ways to improve regionally, but given the growth and in-market demand, we're very pleased with where we are and how Recordati has made commercializing Fiskep a priority. And they even noted the strong growth yesterday themselves in their earnings call. They're also evaluating a number of other countries. I mean, ultimately we'd like to see the ability to launch in France. That would be of course sometime in the future but obviously we have confidence in in our partner to be able to do something there but we just don't have an update at this time as you know it's a lengthy lengthy process there they have partnered with us for 59 countries they're exploring a number of countries that we as Ameren would never even have considered and some of those are sizable markets and and hopefully we'll see how that plays out and we can get reimbursement in those countries and ultimately launch as well so off the ground early back to Italy that's a very big omega-3 market it certainly is one that Recordati knows extremely well very established competent cardiovascular organization and they're off the ground strong and the more they get regional reimbursement and favorable reimbursement there we were excited about what they could do there so overall we're pleased with Europe a lot of work to do very early 15-year partnership as you know and right now we're extremely encouraged. Pete, do you want to touch on the COGS?

Thanks, Aaron. So as you know, COGS is calculated using a weighted average cost of our inventory on hand, which is primarily driven by our API for the volume sold in the quarter. When you look at the comparison from Q2 26 to Q2 25, The increase is due to regaining that PVM exclusive, which was effective in Q3 2025. So when you look at Q3 compared to Q2 in 2026, that material variance and also when you look at Q3 2025 to Q3 2026, that material difference, you should start to see it to level off. You're right that, you know, the primary drivers is that increase in volume. But as we've talked about in the past, we've spent the last few years renegotiating our supply agreements. That's enabled us to drive our inventory levels down to more appropriate levels. But it's also allowed us to manage the cost structure in our purchasing.

Great. Thank you. Thank you, Paul.

Your next question is from Jessica Fai with J.P. Morgan.

Good morning. Thanks for taking our questions. This is Joseon for Jess. On the licensing revenues of $3.1 million in the second quarter, I'm curious if you're seeing any revenues from Record Audio starting to roll in this year, and if so, what should we expect as Record Audio revenues from our public that can happen beyond? Thank you.

I'll comment on growth from an in-market perspective, and then I'll have Pete talk about the revenue side of things. As you know, we're not a business to give revenue guidance, but Pete commented on that. Obviously, the more that they grow in market demand, the greater the acceleration in revenue growth as well. The in-market demand has been tremendous at 69%. for Recordati for Europe. And they just got started. So we're encouraged by what that will do. Obviously, the more we can help them, the more they invested in market demand, the more we'll drive revenue. Pete, do you want to comment on the numbers on revenue specifically?

Yes. On the licensing revenue, that also includes royalty revenue. And so there is a portion of that that is made up from Recordati. There was $1.4 million in royalty revenue for the quarter, which is a growth from Q1. So as you're seeing that in market demand growth, you're also seeing product revenue growth of 11% from Q1 26. So we are seeing that growth. We're encouraged by the continued momentum, the early stages from Recordati. But yes, when you look at the licensing revenue line of 3 million. There is a portion of that related to Recordati. Thank you.

Thank you.

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

thank you operator uh we continue to have strong confidence in our strategy we've got optimism about the scale of the opportunities that lie ahead long-term partnerships a lot of untapped potential uh worldwide and uh certainly we have a tremendous product that continues to provide that benefit so uh we're executing extremely well we've got enormous pride in our team and the commitment and the progress that we're making with this new strategy and we look forward to continued uh to continuing to report those results to you. So thank you all for joining us today. Appreciate you taking the time and look forward to keeping you apprised of our progress. Have a good day.

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