Amarin Corporation plc

Welcome to Ameren Corporation's conference call to discuss its fourth quarter and full year 2022 financial results and operational updates. I would like to turn the conference call over to Lisa DeFrancesco, Senior Vice President, Investor Relations and Corporate Affairs at Ameren.

Thank you, Holly. Good morning, everyone, and thank you for joining us. Please be aware that this conference call will contain forward-looking statements that are intended to be covered under the safe harbor provided under the federal securities law. We may not achieve our goals, carry out our plans or intentions, or meet the expectations disclosed in our forward-looking statement. Actual results or events could differ materially. She should not place under 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 31, 2022, 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. The call is intended for investors in Amron and is not intended to promote the use of the SEPA-VSCEPA. An archive of this call will be posted on Amron's website in the Investor Relations section. Green McHale, Ameren's President and Chief Executive Officer will lead our discussion, and Tom Riley, Ameren's Chief Financial Officer, will provide a more detailed review of our fourth quarter 2022 financial results. After prepared remarks, we will open the call to your questions. I will now turn the call over to Karim Mikhael, President and Chief Executive Officer of Ameren. Karim?

Thank you, Lisa. Good morning, and thank you all for joining us today. While 2022 was a challenging year for Ameren, it was also a year filled with significant accomplishments that we believe have created the foundation for our future and gives us confidence that 2023 will be a year of tremendous evolution for the company. We're only beginning to see the results of the actions we took in 2022 and already in 2023. Throughout the remainder of this year, as each piece falls into place, we will be able to see more clearly the successful turnaround and the growing business that we have been building internationally. Ameren is in a unique position. As we are building value for a product outside of the U.S., while facing increasing generic competition in the U.S. market, Our company is made up of people who come to work every day because they believe in our bold vision to stop cardiovascular disease from being a leading cause of death. This vision is what drives us. I'm proud of this team and what we have been able to accomplish together, and I'm excited for what we are able of accomplishing in the future as we continue to execute on our strategy. Today, I will briefly summarize the actions that we took in 2022 in the spirit of operational excellence to create value over the long term and bring the SEPA to as many eligible patients as possible across the globe. I will also provide an update on our launch in the UK and where we stand with our plans for global expansion. I will provide an update on our results in the U.S. where the team's efforts to stabilize this business is providing the support for our global commercialization efforts. I will then briefly discuss Ameren's presence at the upcoming ACC meeting. Tom will then discuss our financial results for the fourth quarter and our guidance for 2023. And I will conclude with a look ahead at the remainder of 2023. In 2022, we focused on three main areas, global commercialization, preserving our cash, and ensuring that we have the right talent to execute on our new global strategy. We began the year 2022 negotiating pricing in one market in Europe and ended the year with our product available in five European markets. Since the beginning of 2023, we have added a sixth country with Switzerland where we have received individual reimbursement in February. We also have an additional five European markets in advanced stages of pricing and reimbursement negotiations. Our objective is to conclude the vast majority by the end of 2023 as we focus on building a diverse and sustainable revenue stream in Europe. In Spain, we remain active in the reimbursement process and are confident in our ability to secure pricing in this market we have gone through two rounds of review and made solid progress. We anticipate a potential third round of review imminently. In the Netherlands and Italy, we are in advanced stages of our price negotiations and are optimistic a decision could come around mid-year for these markets. We're also making good progress in France, which typically can take slightly longer than the other markets based on historical benchmarks. Other markets such as Norway, Portugal, Israel, and others are also progressing with potential decisions expected this year. We focused on preserving our cash. In the first quarter of 2022, we saw almost $100 million in cash burn. With new members on our management team, we took swift action to renegotiate supply purchase arrangements, We also implemented a comprehensive cost-saving plan in June, and today we are excited to announce that we are on track to exceed our $100 million cost-saving target, thanks to our continued fiscal discipline and cost-cutting efforts, which Tom will discuss in more details later in the call. These actions resulted in a cash flow positive fourth quarter and a year-end cash balance of more than $300 million. And lastly, we also built a strong European commercial organization with expertise in medical affairs, product launches, and with extensive cardiovascular product knowledge. Many of our team members come from companies where they successfully commercialized blockbuster drugs and have significant contacts, expertise, and knowledge of their respective markets. These professionals came to Ameren because of our leading product, our unmatched data, and our entrepreneurial culture. And they are utilizing their background and leveraging their experience to build the Ameren business and brand in Europe. This European team also benefited from the valuable experience that our U.S. colleagues had building the brand successfully over several years in the U.S. market. I'd like now to focus on providing an update on the UK. First, I think it's useful to provide a reminder of the key highlights. We completed our NICE application in July of 2021. Spent the year focusing on securing final NICE approval, which came in July of 2022. 90 days later, in October of 2022, the NHS funding was made available to begin adding VASCEPA to formularies in November of 2022, the national guidelines were published and they included Vaskepa's place in therapy for UK patients. All of these steps and achievements were critical to help us establish a strong position for launch in this market. When we look at the pricing of Vaskepa compared to other oral analogs in the UK, we are extremely well positioned, thanks in large part to the effort of our local team. Given the volume of data available for Vascepa and the efforts of our local team in conveying the value this product brings for patients, our pricing from a daily treatment price perspective far exceeds oral analogs across the cardiometabolic spectrum of products in the UK. When we look at the market access picture of Vaskepa in the UK, initial market access is trending ahead of other recent compatible launches in the market. Our team has unlocked 19 out of the first 20 priority accounts, which collectively represents 50% of the eligible patient population for Vaskepa in the UK. As a reminder, the UK is a market that has a historically slower growing initially in terms of revenue. Based on these trends and the price achieved, we believe there is a viable, strong and long-term business opportunity for Vaskepa in the UK. Moving now to our progress on global expansion outside of Europe. As a reminder, we set out to achieve more than 20 regulatory approvals between 2022, 2024 in international markets. We achieved our 2022 objective of getting approvals in six markets. And already in 2023, we received an additional regulatory approval in New Zealand. And yesterday, following this important approval, we announced an exclusive license and distribution agreement with CSL Sequeiras in Australia and New Zealand. We are excited to announce this agreement with CSL Sequeiras, a world-class pharmaceutical licensing and distribution partner. CSL Sequeres brings highly experienced market access and commercialization teams in Australia and New Zealand that are well positioned to support pricing and reimbursement efforts for Vascepa, particularly with their strong record in successfully supporting pharmaceutical benefits listings and eventual marketing and promotion to help us to deliver this important medicine to patients in these countries. Importantly, Both Australia and New Zealand contributed significant number of patients to reduce it, so it is gratifying to know that we are moving in the direction of giving patients and physicians access to the product there. We expect the next wave of approvals to include China through our partner, Edding Farm. Regarding China, our partner, Edding Farm, is in charge of the regulatory review process. In their latest updates, Edding indicated they expect an approval by mid-year as a result of delays related to the shutdown of the regulatory process in China for a period of time due to COVID-19 restrictions. We are working very closely with Edding to ensure we have the latest update from our partner. As of today, we have not received any indication that there are any open questions or concerns regarding the regulatory filing for our product. In Canada, HLS Therapeutics has obtained reimbursement from all major private and public payers, gaining access to a majority of eligible patients in Canada. HLS continues to be in the launch phase in the public sector, and they are seeing stronger growth for the product in provinces where public access was secured. We're also actively negotiating potential agreements in the Asia Pacific and Central Eastern European regions which would enable us to get this important product into the hands of clinicians and patients and ensure we can extract value from these important markets. I'm pleased with the progress we've made advancing our international expansion plans. We remain focused on our core future objective, which is global growth and expansion for VSIPA, VSCEPA in Europe and internationally, as we believe expansion is the key to creating value for shareholders. we remain confident in the multi-billion dollar market opportunity for Gacipa Vescapa in Europe and internationally. Moving to our U.S. business and our plans for ACC 2023, in the fourth quarter of 2022, we recorded $90.2 million in total net revenue, including $88 million in U.S. product sales, in line with last quarter, despite the continued pressure from genetic competitions. This is the fourth quarter of four consecutive quarters of revenue stabilization in the U.S. in 2022. This unique achievement was only possible through the relentless dedication and efforts of our highly experienced U.S. team on the field and with the managed care organizations. We are continuing to maintain our share in the IT market. Our trends in January and February support continued stabilization of the business. In the first quarter, we're experiencing typical pharma seasonal trends that branded products like the CPEC can expect in the U.S. from fourth quarter to first quarter, driven by co-pays and deductibles resetting for patients and their healthcare plans with a new calendar year. We also expect to see some continued price erosion this year as we continue to experience generic competition. Tom will talk in more details about what we can expect shortly. One compelling fact is that our U.S. team has generated more than $1 billion in sales since generic launched in 2020. And we continue to have multiple levers we can consider to maintain our profitability. As I mentioned earlier, our cost savings are ahead of plan and we have the ability to launch either a brand generic or an authorized generic as needed and at the right time. While we are planning carefully for all potential scenarios, it is clear today that the strong and nimble infrastructure we retained in the U.S. provides us with the right team to continue to support business stabilization in the near term. Lastly, we continue to benefit from the strong data that we have generated with reduces. Four abstracts were accepted and will be presented at the American College of Cardiology, meeting taking place later this week in New Orleans. We are excited to share new findings from the REDUCE-IT trial that add to the wealth of data that has consistently validated the utility of the CEPA in treating patients' populations at high risk of cardiovascular disease. This important information coupled with the analyses comparing the antioxidant effects of EPA, DHA, mineral oil, and corn oil, should help advance the medical community's understanding of the role and value of the SEPA and EPA to reduce cardiovascular events in at-risk patients globally. We remain committed to investing in our data and our medical presence with a global focus to support the medical education efforts for the launches of Vesepa, Veskepa around the world. With that, I'll turn it over to Tom to talk more about our progress and strong results this quarter. Tom?