Amarin Corporation plc

Greetings, and welcome to Ameren Corporation's conference call to discuss its first quarter 2023 financial results and operational updates. I would now like to turn the conference call over to Lisa DiFancesco, Senior Vice President of Investor Relations and Corporate Affairs at Ameren.

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 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 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, and our quarterly report on Form 10-Q for the quarter ended March 31, 2023, 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 Ameren's website in the Investor Relations section. Now turning to today's agenda. Aaron Berg, Ameren's Interim President and Chief Executive Officer, will lead our discussion, and Tom Riley, Ameren's Chief Financial Officer, will provide a detailed overview of our first quarter 2023 financial results. Following prepared remarks, we will open the call to your questions. Steve Ketchum, President of R&D and Chief Scientific Officer, will also be available for Q&A. I will now turn the call over to Aaron Burr, interim president and chief executive officer of Ameren. Aaron.

Thank you, Lisa. Good morning. And thank you everyone for joining us today. I want to start by saying I'm truly honored to lead Ameren during a time of significant transition. Turning Ameren back into a growth story as quickly as possible is what I'm focused on and what I believe will create shareholder value. I'm working with a tremendous sense of urgency and the entire team is focused on driving tangible results. I made the choice to step forward with the support of our new board to serve in this role for a number of reasons. First, my history with this company. I've been with Ameren for more than 10 years now, serving predominantly in my role as head of the US business. Together with my talented, resilient colleagues here at Ameren, I have experienced many ups and downs, and I've come to care deeply for the company, its people, and the patients we serve collectively. And I remain committed to continuing this journey. I believe in our product and our data. We have a tremendous asset in vasepa and vaskepa supported by a wealth of data, particularly the REDUCE-IT trial. Third, I truly believe in our mission to help stop cardiovascular disease from being the leading cause of death globally. And lastly, I believe in the significant value of the opportunity that we have to introduce as many patients as possible to Vasepa and Vaskepa around the world, where there remains significant unmet need in cardiovascular disease. There are millions of patients who can benefit from our product, and we have a real opportunity to make a difference in their lives. The focus on cardiovascular disease prevention is a priority for healthcare providers, patients, and the investment community, because even today, it remains a leading cause of death in many markets around the world. While I've been a member of the leadership team for many years, my focus has been predominantly on the U.S. commercial side, and I'm proud of how we are maneuvering while faced with a very difficult situation in the U.S., and we'll summarize where we are at the moment there. My focus now is on deepening my understanding of the area of business where I have not had any involvement, which is our European efforts. And since my appointment two short weeks ago, I immediately dove right in and spent time with our teams in both Dublin and Switzerland to better understand and evaluate our progress. I look forward to working with the teams cross-functionally to share our many learnings and best practices across the organization. 2023 for Ameren so far has been marked by unprecedented change and evolution. This was driven by a number of factors, including the addition of an entire set of new board members and the appointment of myself as interim president and chief executive officer. The new board and leadership team of Ameren have been working together collaboratively on a regular basis as we rapidly evaluate the path forward for the company. In my view, our near-term strategies are simple. We need to continue to efficiently generate substantial profit in the U.S. In Europe, we're not where we need to be and must immediately work with the team to find ways to accelerate our activities. This means looking at ways to accelerate our revenue growth where we've launched and finding a way to accelerate our pricing and reimbursement access where we still are in negotiations. And we have to do all of this while maximizing cash. This means scrutinizing our spending and implementing additional opportunities to save as we aggressively drive our business. Europe is a difficult macro environment right now, with many of our target markets experiencing economic challenges that impact reimbursement for innovative medications like Veskepa. With consideration given to these conditions, the strong European team agrees we are still not where we hope to be. And I can say, together, we are determined to rapidly identify positive adjustments and execute any additional actions possible to accelerate the pace of progress there. We're doing this with a sense of urgency while also scrutinizing very heavily every dollar that we spend. We have a talented team in Europe with strong expertise. Together with my background and experience with Vespa and Reducit over a number of years, with the opportunities and challenges our team has faced in the U.S., I believe we'll be able to introduce new perspectives and perpetuate some new thinking and fresh ideas. I'll continue to focus on operational excellence in partnership with Tom and the rest of the team as we drive positive progress while scrutinizing investments and preserving cash. Now moving to our business update for first quarter of this year. We reported a solid quarter of stable revenue and lower expenses. This was driven by our business in the U.S., which continues to remain stable. We did experience typical brand dynamics that occur between the fourth quarter and first quarter. We saw volumes decline modestly as expected, but our exclusive contracts with many of our major customers remain intact, and we were even able to improve favorable access and a major plan, which attests to the strong work of our talented team. While Teva, the fourth generic available, has listed both the half gram and the one gram for a number of weeks, we have not yet experienced any significant impact from their launch. We've also seen the approval of a potential fifth generic, which has not yet launched. While our US team remains determined to continue to drive revenue by maintaining branded volume, we stand ready to execute a number of different aggressive scenarios moving forward at the right time, which would ensure we retain our leadership in the IPE market. These scenarios are centered around preserving our profitability and, of course, our cash. Moving to Europe, the teams are continuing to work smart and hard in a challenging environment. We reported $400,000 in net revenues this quarter, reflecting very early revenues from the UK. In the UK, as a reminder, we received final NICE guidance in July of 2022, funding allocation in October, which allows you to begin the process of gaining access to regional formularies, and an update to the National LIPID Guidelines, including VASCEPA, was published in November of 2022, which has been a significant achievement of the local team so quickly after NICE guidance. And the team is making solid progress with access to the market in England and Wales, and that will continue throughout the year. Once you have achieved a good portion of that full access, growth in this market tends to accelerate in a more meaningful way. As we look to the rest of Europe, in Sweden, We're evaluating opportunities to accelerate performance. And we now have Finland with national reimbursement, which could help us drive prescription growth in this region. Our pricing and reimbursement processes in other markets where we filed remain underway. The objective of our commentary is to provide you with an update based on where we are today, as these processes are often difficult to predict. The team continues to navigate through the unique pricing and reimbursement processes in Spain, Italy, and France. In Spain, we've completed a third round of negotiations, which is not uncommon in this market, and the process is ongoing. The next step is another round of negotiations expected in the near term. In Italy, the team is anticipating additional feedback and minutes from a recent round of negotiations in order to determine the best next steps. The process in France is difficult, and we don't expect a decision this year. In the meantime, we're managing the process diligently as we continue to build scientific support. Within the UK and Scotland, we expect to receive feedback shortly with some anticipated additional work needed over the coming weeks to finalize the process there. Overall, what I've learned in recent weeks is that these processes are not easy, that they are complex and do not have consistent structure nor timelines. In addition, the macroeconomic context is unprecedented in Europe, and many companies and assets are facing similar challenges. Regardless of these challenges, we're here and accountable to drive and deliver tangible results. Our path to get there in Europe is to look at ways to do things differently and urgently in both our pricing and reimbursement efforts and our launch efforts. We're looking at everything through a fresh lens across the business to drive results and deliver value. Our team in Europe has recorded important reimbursement successes to date, but there's a long way to go. The teams on the ground in these markets are working tirelessly, and they are not afraid to utilize learnings to take different approaches that can resonate with the pricing and reimbursement authorities. I support and am working closely with them to help accelerate our progress immediately. In our markets outside of Europe, we received approvals this quarter in New Zealand and Israel. The recent approval in New Zealand follows the earlier approval in Australia in November of 2022, and we recently announced a partnership agreement with CSL Securus, who are well positioned to support the pricing and reimbursement efforts in this market. particularly with their strong record in successfully supporting pharmaceutical benefits listings and eventual marketing and promotion for Vescapa and help us deliver this important medicine to patients in these countries. And we're pursuing other partnership discussions in Southeast Asia to expand access to Vescapa in this region. In summary, I'm working closely with the board and with a tremendous sense of urgency as we focus on turning Ameren back into a growth story, because I believe that that is what will create shareholder value. We know that this value will come from generating revenue and doing so with tremendous urgency. That's our focus. We're listening to and we appreciate the input from our important retail and institutional shareholders. I'm committed to keeping the market informed as we evolve through this transition period. With that, I'll turn it over to Tom to talk more about our progress and strong results this quarter.