Amarin Corporation plc

Good day, and welcome to Ameren Corporation's conference call to discuss its first quarter 2024 financial results and business updates. I would now like to turn the conference over to Mark Murmer, Vice President, Corporate Communications and Investor Relations at Ameren. Please go ahead.

Good morning, everyone, and thank you for joining us. Turning to 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 murders, 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, 2023, and our quarterly report on Form 10-Q for the quarter ended March 31, 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 Ameren's website in the Investor Relations section. Turning to today's agenda, Patrick Holt, Ameren's President and Chief Executive Officer, will provide a brief overview of our first quarter 2024 business update. Jonathan Provost, Ameren's Chief Legal and Compliance Officer, will provide an intellectual property and legal update. Steve Ketchum, Ameren's President of R&D and Chief Scientific Officer, will provide an update on key data presented at ACC24. And Tom Riley, Ameren's Chief Financial Officer, will provide a review of our first quarter of 2024 financial results. Following prepared remarks, we will open the call to your questions. I will now turn the call over to Patrick Holt, President and Chief Executive Officer of Ameren. Pat?

Thank you, Mark. Good morning, everyone, and thank you for joining us today. So turning to slide five, look, every day our team in Ameren is focused on making progress to enhance the value of our business and maximize the patient update of the CEPA and VASCEPA. We firmly believe this focus is the best plan forward for Ameren and it will more strongly position us for the future. In Q1, our team continued to deliver considerable progress. So turning to our business highlights first. In the first quarter, we were successful in both defending and extending our IP position in Europe. This effort delivered an extended IP runway in Europe until 2039. This is really important as it enhances the value of our business considerably. Jonathan will provide more details on this achievement later in the call. From a commercial perspective in Europe, our teams delivered approximately 65% in-market sales growth in Q1 2024 versus Q4 2023, led by Spain and the United Kingdom. On the pricing and reimbursement front in Europe, we resubmitted our dossier in Italy. In France, plans remain on track to submit our strengthened dossier in 2024. And in Germany, continued work is being done for a potential resubmission. Additionally, we remain on track to secure pricing reimbursement in five additional markets in 2024 in Europe. We expect to share pricing and reimbursement outcomes in Greece and Portugal in the near future. Our team continues to focus on prudent spending and our cash position. We ended the first quarter with a cash position of $308 million, marking a stable cash position over seven quarters. Importantly, we also secured shareholder approval for our share repurchase program of up to $50 million. Our next step is to secure UK High Court approval and the share repurchases are anticipated to begin in the second quarter. So let's now dive into each of our business areas and the performance in the first quarter. Turning to slide six and more specifically to Europe. Before we get into the results for the quarter, let me reiterate an important point that drives our confidence in the opportunity across Europe. Underpinning our progress and our path forward in Europe is our intellectual property position for Vaskep, which is now being extended into 2039. This provides additional value for both patients and our company. So turning to the first quarter's commercial progress in Europe. In Spain, our team is delivering robust launch growth, and this market continues to prove the value of ESCEPA for the region and, frankly, globally, and the new approach we have taken to the region following new leadership changes last year. As at the end of the first quarter, the number of patients on VASCAPA therapy in Spain has increased 91% in quarter one 2024 versus quarter four 2023. The team continues to focus on HTPs who are early adopters of cardiovascular products. In the United Kingdom, our team is executing against a more focused strategy and has new leadership in the form of a new country manager in place. At the end of the first quarter, the number of patients on vascapotherapy in the UK has increased 28% in Q1 2024 versus Q4 2023. Turning to pricing and reimbursement progress, we have strengthened focus on advancing our opportunities in key EU5 markets. In Italy, we resubmitted our dossier and we're advancing this process with the authorities to potentially achieve market access for VASCEFA by the end of 2024. In France, plans remain on track to submit our strengthened dossier in 2024. And in Germany, continued work is being done on plans for a potential resubmission. We will continue to communicate progress on France and Germany as additional steps are achieved. In addition, we're pleased to share today that we're well on track to reach our goal of securing positive pricing reimbursement DOTS decisions in at least five additional markets in 2024. We expect to share news on pricing reimbursement outcomes in Greece and Portugal in the near future. Turning now to the United States, in the first quarter, the team maintained IPE market leadership. We have retained exclusive accounts representing more than 50% of the IPE market. Market share has remained stable in the U.S. for the sixth consecutive quarter. These results are a testament to the work our managed care, trade, and medical affairs teams have done to extend the CESA's life cycle despite the elimination of our sales force and reduce marketing spend. While we are encouraged to start the year in a solid managed care position, the market remains highly dynamic. Whilst our revenues in the quarter were impacted primarily by a decline in net selling price due to generic competition, the US business remains highly profitable, funding our efforts in Europe. Our U.S. team is skilled at analyzing market dynamics, and we are prepared to change our approach to this business as the market continues to develop, including the potential future launch of an authorized generic, which would be bolstered by our strong supply position in order to retain IP market leadership. Moving to slide A, in the rest of the world, Ameritrade and its partners continue to make regulatory market access and commercial launch progress across key markets. In China, the second largest cardiovascular market globally by population, Ameren's partner, Edding, continues to launch the CIPA for very high triglycerides with a focused strategy. In the first quarter of 2024, Edding delivered a 100% increase in sales growth versus the fourth quarter of 2023. The NMPA review of the cardiovascular risk reduction indication remains on track, and as a reminder, an approval for this indication would open up the potential of National Reimbursement and Drug Listing, or NRDA. In Canada, HLS continues to make important progress across the market. In British Columbia, HLS recently secured public access and listing with the leading private payer, Pacific Blue Cross, for Vaskepa. And in Australia, Ameren's partner, CSL Securus, continued to advance the submission for Vaskepa reimbursement with local health authorities, and timelines for potential reimbursement remain on track. In summary, our teams and our partners have made significant progress in the first quarter across the business, advancing momentum needed for Amazon. Like all biopharmaceutical companies, intellectual property is a foundational element of our business and our ability to provide our product to patients. I would now like to turn the call over to Jonathan Provost to provide more detail on our IP extension for Vescapra in Europe. Jonathan?