Amarin Corporation plc

Welcome to Ameren Corporation's conference call to discuss its third quarter 2024 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 afternoon, 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 factors section of our annual report on Form 10-K for the year ended December 31st, 2023, and our quarterly report on Form 10-Q for the quarter ended September 30th, 2024, which has been filed with the SEC and is 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 the Ameren business. Pete Fishman, Ameren's Vice President and Global Controller, and currently overseeing all finance-related matters for the business, will review our third quarter 2024 financial results. At the end of the presentation, there will be the chance to ask questions. I will now turn the call over to Aaron Berg, President and Chief Executive Officer of Ameren. Aaron?

Thanks, Mark. Good afternoon, everyone, and thanks for joining us today. In my first full quarter as the President and CEO, I spent time with our teams both in the U.S. and Europe, as well as valuable time with many of our partners and scientific experts from around the world. My aim has been straightforward. to determine our path forward and execute the best strategies to drive access to and use of Vesepa, Veskepa for the millions of at-risk patients across the globe. What I've known for years from the U.S. experience with Vesepa was confirmed by those stakeholders I've heard from in Europe and around the world. Veskepa has the potential for significant growth, value, and impact globally that remains substantially untapped. These dynamics create a tremendous opportunity, one that directly addresses cardiovascular risk worldwide, and it's our obligation to patients, providers, and payers, as well as to shareholders, to accelerate access to and use of this tremendous product. While our team has been working very hard and has made progress, this progress has not been enough. We're still in the early stages of launch in many regions around the world with a long runway, and there remains much more to do to maximize the value we know is inherent in the global Vesepa and Veskepa franchise. This is based on the need, the science, and the impact this product can bring for patients. Let me start with the most critical component of all, the global unmet need to reduce cardiovascular disease. Despite more than four decades of progress in cardiovascular medicine, cardiovascular disease remains the number one killer globally. In 2021, roughly 20 million deaths were estimated for cardiovascular disease globally, which amounted to an increase of almost 22% for the prior decade. It's astonishing. that with even all the therapeutic innovation and progress we've made, this disease remains such a burden for patients, families, healthcare professionals, and systems globally. As a result, the reduction of cardiovascular events remains a top priority for healthcare providers, patients, caretakers, and payers, public and private. While LDL cholesterol is the primary target of lipid therapy, reduction of LDL isn't enough. More can and should be done to help patients reduce the risk of cardiovascular events through expanded access to existing and future treatment options that have been proven to reduce that risk, namely products like Vasepa and Vaskepa. Just in Europe alone, there are more than 6 million at-risk patients who are eligible for Vaskepa based on the approved label. And this does not include the millions of patients in Europe and around the world treated with triglyceride-lowering fibrate and omega-3 mixture products for patients being improperly used these drugs to treat cardiovascular risk. Even though these products may impact biomarkers, the large, well-controlled cardiovascular outcome trials with tens of thousands of patients have failed to demonstrate a reduction in cardiovascular events. Changing lipid biomarkers is no longer enough and can create a false sense of security for providers and patients alike. Many of these patients need to be on a treatment proven to reduce cardiovascular events. Doing more for many of these patients should include the use of Vescepa. And this is not just our opinion. When we look at Vescepa Vescepa, it's a proven product backed by science and strong support across the global medical community Over the last 10 years, more than 300 scientific publications have been generated confirming the unique attributes of Vesepa and Veskepa, anchored by the landmark REDUCE-IT trial, and confirming that Vesepa and Veskepa, in combination with the statin, provides an important option for patients globally who need to further reduce their risk of a cardiovascular event. As a result, this science has been recognized by the global medical community, evidenced by the more than 50 leading medical societies across 20 countries that have issued guidelines and scientific statements supporting the therapeutic value of icosapenethyl to address cardiovascular risk. In addition, thousands of scientific leaders and prescribers, as well as numerous payer and reimbursement authorities around the world, support the product. The scientific community continues to build on the existing science by conducting and publishing further studies and analyses of its utility in certain at-risk subpopulations and continued ongoing work to further elucidate the mechanism of action. We also know that this product has significant value and a long runway for growth, particularly in Europe, with recently granted IP out to 2039. Our confidence is evidenced by the experience we've had with the product over the last five years in the U.S. since the FDA approval of the cardiovascular risk reduction indication. In the U.S., following the readout of the REDUCE-IT trial, the reception was remarkable for this product by the scientific community and the potential to positively impact millions of patients with VSEPA. The REDUCE-IT data generated incredible demand for VSEPA. prescriptions increased significantly and product revenue rose substantially. We witnessed a greater than 50% increase in the number of prescribers, totaling 200,000 in the U.S., resulting in more than 80% growth in new prescriptions in the first year post-publication of Reduce-It. This history of uptake and market response provides evidence that, with time to promote and educate, and supported by outstanding execution, providers respond favorably to the SEPA as a therapy that can benefit their patients. If we apply that experience and learnings from the U.S. to Europe, we know that SEPA has the potential to grow substantially with a large eligible patient population based on the approved label and the extended runway out to 2039. We know we're still in the early days of this opportunity in Europe. Our teams in many markets in Europe are just now beginning the education process, and we have only scratched the surface of our pricing and reimbursement and launch progress in many markets. To date, we've unlocked access and launched in eight European countries, but this only represents about half the market access opportunity in Europe. We've learned that launching in Europe takes time, and there remains significant potential to further expand access to Veskepa for at-risk patients in a number of additional European countries. The same holds true for many markets in the rest of the world, and we've been opportunistic in many of these markets. We currently have nine partners who we're collaborating with across a number of markets. and we're in the early stages of obtaining reimbursement and launching in some of these important regions. As for the U.S., the company benefits from continued cash generation from the brand tail as we continue to focus on extracting maximum value. The cash generated from our U.S. sales continues to support operations for the company. In summary, the combination of the current unmet need for patience, the strength and extent of scientific community support of clinical data, extended runway in Europe, and the opportunity for expanded access, as well as the proven uptake and clear impact on reducing cardiovascular risk around the world, translate into a growth and value opportunity for Vespa, Vescapa, that we remain laser-focused on further expanding every single day. And to that end, our focus is clear. To prioritize execution and performance, while urgently evaluating all opportunities to expand the impact of ESCEPA to millions of patients worldwide. That's our commitment to patients, providers, payers, and, of course, to shareholders. Now let me turn to some of the operational highlights our team has delivered in the third quarter and year to date. Turning to slide six, our recent progress provides yet further evidence that the value and opportunity of Vescepa Vescepa is being recognized and validated. In Europe, our focus has been on accelerating revenue in key launch markets while advancing pricing and reimbursement processes. Earlier this year, as mentioned, our team successfully advanced our intellectual property position in Europe, extending our IP for Vescepa through 2039. This is important as it extends the runway to realize the true value of this product for patients in Europe. On the commercialization front, while our revenues continue to grow, powered by continued sales growth in the UK, Spain, and in Central and Eastern Europe markets, we're in the early stages and know we must accelerate growth where Vescepa has been launched. We've also continued to advance our pricing and reimbursement efforts to extend access to Vescepa for more patients across Europe. Year-to-date, we have now secured pricing and reimbursement in Greece and Portugal. And in Italy, our team has continued to take steps with pricing and reimbursement authorities, and we hope to be in a position to share news soon in this key market. Turning to the U.S., our team remains focused on retaining a co-spin-athlete market leadership for Vesipa and extracting as much value as possible for this business, despite additional generic competition and pricing challenges. Through the first three quarters of the year, BESIPA has maintained a leadership position with greater than 50% share of the IPE market. We continue to follow the competitive landscape as well as reimbursement and pricing dynamics and will continue efforts to maintain a leadership position. As an important reminder, we've been sustaining a high level of market share capture with BESIPA following the shift to a generic market in 2020. a noteworthy track record due to the unique attributes of this product. The US market remains the main source of revenue for the company and currently the primary funding source in support of our expansion plans. And of course, we also continue to assess the optimal time to launch an authorized generic into the US market. Across the rest of the world, our focus has been to extend access to Vesepa Veskepa through partnerships, growing the sustainable opportunity across these markets. We're making important progress in this effort through pricing and reimbursement processes and commercialization with our partners. Let me touch on two examples. In Australia, our partner CSL Securus secured Australia's Pharmaceutical Benefits Scheme price listing for Veskepa unlocking public access to the product for patients in that market. CSL is now launching Vescepa, and we expect to realize the impact of such partnership-based sales beginning in 2025. And in China, through the first nine months of 2024, our partner, Edding Farm, received regulatory approval for Vescepa for the cardiovascular risk reduction indication, which is a significant milestone for the drug, given that China is the largest market for cardiovascular-related products. Edding is following up that success with continued efforts to secure a national reimbursement drug listing in China. Supporting all of our commercialization and expanded access efforts worldwide are our medical affairs, R&D, and regulatory teams who expertly and tirelessly advocate for and conduct the critical work to advance the science behind Vesepa and Veskepa. Nearly five years from the approval of Vesepa 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 value of vasepa-vaskepa to reduce cardiovascular risk when used as an adjunct to statin therapy to benefit patients further. So far this year, our teams, along with KOL partners, have presented more than 25 publications and abstracts that both individually and in aggregate help to advance an ever-broadening understanding of the science and value of IPE and EPA. Two recent examples of this important study drumbeat include recent abstracts and presentations at the European Society of Cardiology meeting in August and the European Association for the Study of Diabetes meeting in September. Importantly, this recent research has provided new insights on EPA's potential effect when elevated levels of lipoprotein little a thought to be a key factor in cardiovascular risk and mortality for at-risk patients. And our team will be supporting three abstracts at the upcoming American Heart Association meeting in November. We intend to continue to further advance this evidence on the utility and value of the SEPA, the SCEPA, and IPE. Our teams have also made regulatory progress so far this year with approvals for our product for cardiovascular risk reduction in South Africa and China. In summary, it's our obligation to get the SEPA VSCEPA into the hands of as many patients around the world as possible. We've made progress under sometimes difficult market and reimbursement challenges, but as more stakeholders become increasingly educated on the strength of the VSCEPA clinical data and what it means for patient care, our confidence in this product's global potential continues to grow. Now, let me turn the call over to Pete Fishman, who will review our third quarter 2024 financial results. Pete.