Amarin Corporation plc

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 will contain 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 factor section of our annual report on Form 10-K for the year ended December 31st, 2024, which has been filed with the SEC and is available through the investor relations section of our website at www.amarincorp.com. We encourage everyone to read these documents. An archive of this call will be posted on Ameren's website in the investor relations section. Turning to slide three in today's agenda, Aaron Burr, Ameren's president and chief executive officer, will provide an update on the state of the Ameren business. Pete Fishman, Ameren's chief financial officer, will review our fourth quarter financial results. And Steve Ketchum, Ameren's Executive Vice President, President of R&D, and Chief Scientific Officer, will provide an update on recent and upcoming BESIPA-BESCEPA research. And at the end of the presentation, Aaron Berg 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 thank you for joining us here today. Let me begin my comments by focusing on our progress and the opportunity ahead to realize the value of ASEPA globally, as well as the ADS ratio change referenced in the press releases this morning, a strategic action we've taken to address a key issue for the company. Since taking on the role of CEO in the middle of last year, I've spent a significant part of that time working with our leadership team and in coordination with the board of directors, to identify and take advantage of opportunities to rapidly accelerate momentum, strengthen the foundation for long-term growth, and drive greater value now and for the future. We've made progress in this effort, and the opportunity that we have ahead with the SEPA is built on a strong foundation. We have a strong foundation financially with 2024 revenues of over $200 million, and a cash position of almost $300 million and no debt. This financial position helps solidify a long runway for Ameren. The science of ASEPA, which is underpinned by the REDUCE-IT study and more than 500 additional publications advancing understanding of the icosapent ethyl clinical benefits and mechanism of action and its complementary position to impact the cardiovascular risk burden and unmet need around the world. This extensive science has helped to drive regulatory progress globally. To date, we've secured approvals in 49 markets around the world where we're in the early stages of obtaining pricing and reimbursement agreements, commercial launches, or still progressing through the regulatory approval processes, all of which set the stage for future growth. Increasingly, we've expanded access to commercial penetration with the product launched in more than 20 markets globally, either directly or through our nine partnerships in place currently. There are also 16 additional countries in various stages of progress toward commercialization. The significant revenue generation led by continued capture of efficient brands and revenue in the U.S., followed by growth in Europe and rest of the world markets. This solid and growing foundation positions for the SIPA franchise to deliver on its tremendous opportunity globally. We know we have much more work to do to capitalize on this opportunity, but overall, taking into consideration the considerable untapped potential of the franchise, our continued progress in its global expansion, and the financial foundation and long cash runway we have in place, we believe there is a disconnect between the value potential and our current company valuations. Regarding the ADS ratio change, as a publicly traded company, we see considerable value in maintaining our NASDAQ listing. To that end, today we announced our intent to initiate a ratio change to our ADS program in order to preserve our NASDAQ listing. This step is an expression of our determination and commitment to realizing the full value potential of Ameren. Pete will cover this in greater detail later in the presentation. and I encourage everyone to review today's press release on this matter for additional information. Turning to slide six, let me now briefly walk you through the past 12 months plus and provide details on our progress and key accomplishments, including the strategic decisions and steps we've taken that have helped us drive value. From a strategic standpoint, we successfully extended our intellectual property position in Europe, widening our IP horizon for Vescepa, through 2039. This is important as it extends the runway for exclusivity and the opportunity for this brand in Europe. We've continued to execute our new commercial and pricing and reimbursement strategy in Europe, tailored to each country and focused on very high-risk patients. These are patients with established cardiovascular disease, and there are currently over 5 million such patients in Europe, a significant opportunity to impact a large patient population. This strategy has accelerated our progress in the region. We've secured pricing and reimbursement in 10 markets since adopting this new strategy, and in-market demand grew in every launch market in Q4 versus Q3. We've also continued to focus our financial strategy on efficient cash management and operating expense deployment, focused only on the most value-driving efforts. This has helped us extend our cash runway. Finally, as I mentioned, we announced earlier this morning that we're taking steps to maintain one of our critical corporate assets, our NASDAQ listing. Operationally, we've made continued progress across the business. In Europe, on the commercialization front, the SCEPA revenues continue to gradually increase throughout 2024, driven by growth in Spain, the UK, and Central Eastern Europe markets. While we've seen early demand in a number of these markets, we must find ways to accelerate growth where Vescepa has been launched. Pricing reimbursement efforts have also advanced, with pricing reimbursement secured in Italy, Portugal, Greece, and most recently last month, in Austria. Importantly, in Italy, we've already secured access in nine regions, which represent more than 50 percent of the total eligible market in that country. reflecting strong interest in gaining access to the product in the market. In the US, throughout 2024, we've continued to efficiently generate cash with Basipa more than four years after the introduction of generic products. Exclusives, which now represent 74% of the total Basipa branded business, cover approximately 43 million total lives which represents approximately 40% of the total commercial and Medicare Part D IPE volume. Additionally, as we previously stated, we have a plan of action and are prepared to launch an authorized generic when the time is optimal. Across various regions of the rest of the world, 2024 saw continued progress in regulatory efforts, expanding access and generating demand for VSIPA through existing partnerships. While early in the launch phase for a number of these markets, all partners saw growth in market demand for the product in Q4 and continued to work to expand access and further accelerate growth. Two of our partners launched in cardiovascular risk reduction, Edding Farm in China and CSL Securus in Australia. Edding Farm received regulatory approval in China mid-year for cardiovascular risk reduction and are now focused on promoting for at-risk patients with access to private hospitals and high-risk patients in public hospitals, with inpatient acute coronary syndrome patients as the priority in this initial stage of the commercial cardiovascular risk reduction launch. Their effort is currently focused on the self-pay market in China as they continue advancing efforts to support inclusion on the National Retail Drug Listing, or NRDL. In Australia, our partner, CSL Securus, secured Australia's pharmaceutical or PBS price listing for Vescapa, unlocking public access to the product for patients with ASCBD and elevated triglycerides in that market. CSL officially launched at the annual scientific meeting of the Cardiac Society of Australia and New Zealand in August 2024, the largest cardiology meeting in Australia and New Zealand, with more than 400 delegates attending. While very early, they're seeing strong in-market demand in Australia. HLS received reimbursement in Alberta to round out their full public access across the country, adding opportunity for growth beyond their significant private insurance coverage for Canada. Biologics in the MENA region progressed their commercial efforts and saw increased sales in the region. They worked to continue their growth in Saudi Arabia specifically as they worked with the health authorities to further expand access to the patients with public reimbursement there. We continue to progress our regulatory efforts in Southeast Asia, where our partner is Lotus, and expect first approvals to be sometime in 2026. Ameren continues to support our partners with our medical team through attendance and international scientific leader involvement at multiple medical conferences, specific scientific leader programs, launch efforts, as well as working to secure publications locally for the commercialized regions. Supporting our efforts to generate worldwide growth are our medical affairs, R&D, and regulatory teams who continue to expertly and tirelessly advocate for and advance the science behind the CIPA. More than five years from the approval of the CIPA in the U.S. for cardiovascular risk reduction, we and others are continuing to generate meaningful data that helps the clinical community further understand the underlying science and the potential added benefit of the CEPA to further reduce the risk of cardiovascular events in patients on standard of care therapy with well-controlled LDL levels. This significant and continuously expanding body of evidence helps propel our commercial, medical advocacy, and regulatory progress, which Steve will review in greater detail later. And finally, from a financial perspective, we continue to make smart decisions to balance operating expenses and cash preservation with the urgent need to accelerate global revenue growth. Specifically, we closed out 2024, having generated $228.6 million in total revenue and a stable capital structure. For the year, we reduced our year-over-year operating expenses by 26%, including the $50 million annual operating expense reduction we committed to in 2023. We ended the year with a strong cash position of $294 million, underscoring our prudent cash management and continued focus on strengthening our financial foundations. Financial accomplishments were accompanied by our successful efforts to renegotiate product supply agreements. These successful negotiations allow us to align our short-term supply commitments based on current demand in order to conserve important capital while ensuring we can supply the brand across markets as we build momentum with a growing global customer base. In summary, 2024 was a year of continued progress in numerous aspects of our business, driven by the execution of the entire Ameren organization. We take very seriously our obligation to drive shareholder value, and while we've made progress, we have much more work to do to drive shareholder value, primarily by urgently getting Vesipa into the hands of as many at-risk patients around the world as possible. We know the unmet need is there, And while the last several years have been challenging, we've remained steadfast in our efforts to drive continued positive progress in realizing this product's global potential. We've remained confident we will generate further momentum in 2025, building off 2024. With that, let me turn the call over to Pete Fishman, who will take us through the financial results, as well as the specifics regarding the ADS ratio change announced earlier this morning. Pete.