Amarin Corporation plc

Good day ladies and gentlemen and welcome to the Ameren Corporation's first quarter 2026 results conference call. At this time all participants are in a listen only mode and 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. And please note, this conference is being recorded. I will now turn the conference over to your host, Mr. Devon Sullivan. Sir, you may begin.

Thank you for your time and attention this morning as we discuss Ameren'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.amerincorp.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 Security 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. The momentum that started to build in late 2025 continued in the first quarter of 2026. Our results in cash generation in the quarter demonstrate our progress in advancing our new business model and expanding the global market for Resipa to our new and more efficient operating platform. We've substantially completed our previously announced global restructuring, and we've remained on track to achieve the estimated $70 million in total operating expense savings by June 30th, 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 two 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 31st, 2026, Recordati had commenced sales of Vescappa 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 and key launch markets. We remain encouraged by these early performance trends. Liquid 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 Vescepa 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 Vescepa for cardiovascular risk reduction based on the strength of the reduced trial. Recordati recognizes this as well and has prioritized the rollout of Vescepa 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 a submission in Vietnam in Q1 2026, We're on track to submit a new filing in Malaysia in Q2, 2026. Our US team continues to operate the core business, which serves as a cash generating base. As we've stated, while our US franchise continues to see revenue declines due to the pressures of generic competition, that SEPA remains the clear U.S. market leader across all available icosapid ethyl products more than five 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 31st, 2026, up from 42% in the same period last year. Most impressive is that the SEPA branded prescriptions rose by 17% in Q1 2026 versus Q1 2025. The steps we've taken to right-size 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 non-exclusive 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 that SEPA's ability to reduce cardiovascular events by 25% when added to a statin. 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 advisor, Barclays, in exploring additional potential pathways to further enhance shareholder value. Now let me talk about some additional VSIPA developments. In late 2025 and early 2026, we highlighted new post hoc analyses from the REDUCED study of statin-treated patients with elevated triglycerides and known cardiovascular disease or with diabetes and other risk factors. In these analyses, treatment with VSIPA 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 Vesepa 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 the SEPA 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 nine other leading US 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 reduced cardiovascular outcome study in the SEPA. Within this updated ACC AHA clinical treatment guideline, icospin 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 icosapenethyl. This position is consistent with guidance from other cardiovascular societies, including the 2025 ESC-EAS Dyslipidemias Guideline-focused update, which states that high-dose icosapenethyl, 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 risk 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 the SEPA 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 Vasepa by strengthening its inclusion in the treatment flow from physician to formulary to patient. More than 500 peer-reviewed publications validate the science behind Vasepa. 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 healthcare 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. A SEPA taken orally is widely available, well-established, and supported by a clinically proven efficacy and safety profiles. 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.