Amarin Corporation plc

Welcome to Ameren Corporation's conference call to discuss its first quarter 2025 business update and financial results. I would like to turn the conference call over to Mark Marmer, Vice President, Corporate Communications and Investor Relations at Ameren.

Good morning, everyone, and thank you for joining us. Turning to slide two in our forward-looking statements. Please be aware that this conference call contains forward-looking statements that are intended to be covered under the safe harbor provided under federal securities law. We may not achieve our goals, carry out our plans or intentions, or meet the expectations disclosed in our forward-looking statements. Actual results or events could differ materially, so you should not place undue reliance on these statements. We assume no obligation to update these statements as circumstances change. Our forward-looking statements do not reflect the potential impact of significant transactions we may enter into, such as mergers, acquisitions, dispositions, joint ventures, or any material agreements that we may enter into, amend, or terminate. For additional information concerning the risk factors that could cause actual results to differ materially, please see the risk factors section of our annual report on Form 10-K for the year ended December 31st, 2024, and the quarterly report on Form 10-Q for the quarter ended March 31st, 2025, which have been filed with the SEC and are available through the investor relations section of our website at www.amroncorp.com. We encourage everyone to read these documents. An archive of this call will be posted on Amron's website in the investor relations section. Turning to slide three in today's agenda, Aaron Berg, Ameren's President and Chief Executive Officer, will provide an update on the state of our business. Pete Fishman, Ameren's Chief Financial Officer, will review our first quarter 2025 financial results. And at the end of the presentation, Aaron will provide closing remarks followed by a question and answer session. I will now turn the call over to Aaron Berg, President and Chief Executive Officer of Ameren. Aaron?

Thank you, Mark. Good morning, everyone, and thanks for joining us today. I want to start by sharing some of the key accomplishments that point to the foundational work that's been done over the last two years, setting the stage for meaningful future growth for the company. In the U.S., we continued our strategy of focusing on managed care access to maximize branded revenue in an increasingly genericized market. In Europe, our revamped leadership team implemented a new targeted strategy focused on a very high-risk patient group, those with established cardiovascular disease, or ECVD. This population eligible for the SCEPA is estimated to be more than 6 million patients in secondary prevention in Western Europe alone. This strategy has been pulled through in both pricing and reimbursement efforts, as well as the overall brand strategy. We also extended our European IP out to 2039, providing a much longer runway to maximize the value of the SCEPA. We expanded our rest of the world presence by entering into additional regional partnerships, including in Southeast Asia, MENA, and Australia. Our R&D and medical affairs teams continue their efforts on advancing medical community understanding around the science and potential of the SCEPA to impact CV risk globally. And we also took aggressive, meaningful steps to reduce operating costs, manage our cash, and improve our supply position. With these strategic and operational actions, we've strengthened the foundation of the company, improving the potential for future growth, and while still early on, we are seeing tangible results. Since the first quarter of 2023, we've significantly increased the number of countries globally where Vesipa is reimbursed and launched, from 7 in 2023 to 21 today. While many of these countries remain in the early stages of commercialization, the steps we've taken widen and deepen the footprint for broader patient impact and further diversify sources of revenue generation. We've stabilized Vesepa as a profitable enterprise in the US and have maintained a leading market share. Vesepa is accelerating revenue growth, albeit off a small base, across European markets with patent protection through 2039. While encouraging, we know there's tremendous untapped opportunity in Europe and room for significant growth. We've achieved regulatory and early commercial success through our rest of the world partnerships. Vesipa is now commercialized in nine rest-of-the-world markets to date through these partnerships. Our R&D and medical affairs teams have continued to advance the science behind Vesipa with nearly 100 abstracts and publications, more than 150 educational initiatives since 2023 across Europe, and a strong presence at major global medical congresses. And we've efficiently managed our cash over 10 consecutive quarters while maintaining a debt-free balance sheet. While we're proud of this progress, we know we're just scratching the surface of the SIPA's full potential in many markets globally. And we have much more work to do in pursuit of opportunities to unlock the value of the product and the company as a whole. We're moving with purpose. determined to advance patient treatment and reduce cardiovascular risk globally while delivering value to shareholders. And we will continue to take any steps to assure we're on the right path to realizing the full potential in the near term. This is very much top of mind for our board and management team and has been the guiding force behind the transformational strategic, operational, and financial improvements we've made over the last several years. Now let's turn to our first quarter performance. Turning to slide five, in the first quarter of 2025, we made meaningful progress across every facet of the business, strategically, operationally, and financially. Progress that continues to position us well to realize the full potential of the Vesipa franchise and maximize value for patients and shareholders. Overall, we've made progress in our three key segments. First, in Europe, on the commercialization front, Vescapa revenues continued the gradual growth we saw in 2024, with $5.4 million in revenues in the quarter, representing 16% sequential quarterly growth. This early yet meaningful growth was driven by continued success in Spain, the UK, and Central Eastern Europe markets. Building on this success, we continue to find ways to accelerate growth where Vescapa has been launched. In Italy, the team has been focused on pricing and reimbursement to expand regional access. We've secured access in 14 of 21 local regions to date, which represent more than 85% of the total eligible market in Italy, reflecting positive interest in high-density areas. This initial market access work sets the stage for a more efficient and effective broad commercial launch to drive anticipated growth later in 2025. Elsewhere in Europe, our team has made meaningful progress on market access and advancing pricing and reimbursement efforts. Specifically, we secured reimbursement in Austria and launched commercially in April. We also continue active engagement with authorities in Norway and Ireland with decisions in those markets expected later this year. Second, in the U.S., we are continuing to efficiently generate cash with this SEPA more than four years after the introduction of the first generic products. We began 2025 by retaining all of our major exclusive accounts from Q4 2024, and that continued through the first quarter. This is a positive sign as we continue focusing on generating revenue and maximizing the profitability of the U.S.-branded business. Similar to the seasonality impact we experienced in 2023 and 2024, we expect to see prescription volume pick up in the second quarter with possible declines in the third and fourth quarter. Moving forward, given market dynamics, while we anticipate year-over-year declines consistent with prior years, we continue to extract strong value from the U.S. through efficient, focused commercial execution and remain prepared to launch our authorized generic when deemed necessary and advantageous to the company to fully maximize the contribution for the product through its lifecycle. And third, across various regions in the rest of the world, 2024 was a year where together with our partners, we drove regulatory progress in many markets and in 2025 have shifted to focusing on early commercialization. We began 2025 by working with our partners to drive early demand for Vesepa across many markets. Benning Farm in China continued advancing promotional efforts in cardiovascular risk reduction for at-risk patients with access to private hospitals and high-risk patients in public hospitals with inpatient ACS patients as the priority in this initial stage of the commercial CVRR launch. Their efforts are currently focused on the self-pay market in China as they continue working towards inclusion on the National Retail Drug Listing, or NRDL, for 2026. As a reminder, China is a very large market opportunity for Vasepa, with an estimated 330 million CBD patients and one of the highest CBD death rates in the world. According to a recent report on cardiovascular health and disease in China, CBD accounted for 44 to 47% of all deaths in urban and rural areas, meaning two out of every five deaths were due to CBD. We're confident Edding can make a difference in this critical market with the CIPA. In Australia, through the efforts with our partner CSL Securus, ASCEPA was included in a new clinical guideline for diagnosing and managing acute coronary syndromes issued by the National Heart Foundation of Australia and Cardiac Society of Australia and New Zealand. And most recently, the 2024 edition of Management of Type 2 Diabetes, a Handbook for General Practice by the Royal Australian College of General Practitioners, now includes Vescapa in the lipid lowering medication overview section under complications, type 2 diabetes, and cardiovascular risk. This means we now have two strong local clinical recommendations supporting Vescapa use. These are important milestones that reinforce the value of Vescapa in helping reduce cardiovascular risk in high-risk patients, from those patients with recent ACS to those living with diabetes. While still very early in the launch, CSL Securus is continuing to see strong in-market demand for Veskepa. The opportunity to make an impact on cardiovascular disease risk in this market is notable, and we've seen a steady in-market demand increase since launch in January. According to the Australian Institute of Health and Welfare, approximately 1.3 million patients in Australia have established cardiovascular disease, which represents a significant opportunity for Mesquepa. Biologics continue to advance market access efforts in the MENA region, including important progress with the Ministry of Health in Saudi Arabia to further expand access for patients with public reimbursement there. This progress is important because with over 30% of adults over 18 at risk of CBD in the Kingdom of Saudi Arabia, there is an urgent need to address CBD there. Across Southeast Asia, regulatory efforts advanced in seven additional markets led by our partner, Lotus, currently keeping us on track for first approval in the region in 2026. These markets provide additional opportunities to drive future growth. In addition, We continue to advance the science supporting the SEPA globally by leveraging our medical affairs team through attendance and international KOL involvement in education and multiple major global and regional medical conferences, complemented by local educational efforts to strengthen scientific advocacy and launch activities. We also continue to pursue securing additional scientific publications in numerous regions locally, primarily focused on commercialized markets. Together, these efforts reinforced the growing global demand and potential for Vesipa, backed by a solid foundation of science, regulatory approvals, and partnerships with strong commercial presence. From a financial perspective, we took decisive action to address a key overhang for the company and continued to make smart decisions to balance spending with cash preservation, always with a focus on driving shareholder value. Specifically, we took proactive action to address our listing status on NASDAQ by completing a 1 for 20 ADS ratio change to preserve our NASDAQ listing. With this complete, we have regained full compliance with NASDAQ. And we continue to keep our operating expenses in line and importantly, retained a solid cash position with no debt. In summary, the first quarter provided continued foundational progress for our path ahead. We have a global product with a broad label in many markets, demonstrating proven therapeutic impact and value in the fight against CBD, the number one killer worldwide, and in changing the lives of at-risk patients wherever it's available. We have a global network supporting the SEPA, Ameren has a solid financial base with no debt that can support our operations and growth into the future, and we have a dedicated team committed to seeing through the realization of the true potential of a SEPA and further cementing our role in impacting the lives of patients worldwide. While we focus on the opportunity for this product around the world, we will do so prudently and with a significant focus on the bottom line. As we've always done, We will continue to look for opportunities to reduce operating expenses while investing wisely to maximize the value of the product globally. And with that, let me turn the call over to Pete Fishman, who will take us through the financial results. Pete?