Amarin Corporation plc

Welcome to Ameren Corporation's conference call to discuss its third quarter 2023 financial results and business updates. I would now like to turn the conference call over to Jordan Zwick, Senior Vice President, Business Development and Investor Relations 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 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, We 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 September 30, 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. Turning to today's agenda, Patrick Holt, Ameren's President and Chief Executive Officer, will lead our discussion, and Tom Riley, Ameren's Chief Financial Officer, will provide a detailed review of our third quarter 2023 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, Jordan. Good morning, and thank you, everyone, for joining us today. During my three months with Ameren, I've been focused on ways to drive shareholder value. What I have learned is clear. First, we have a company and a product in Vesipa Vescafa with significant global potential. backed by tremendous scientific data, including a 25% relative risk reduction on top of statin, and is therefore a medicine that can have profound impact on cardiovascular patients globally. In addition, the company has a strong balance sheet with $321 million in cash, delivering five quarters of cash flow positive results and no debt, I also know that delivering and showing results is what will drive shareholder value at Ameren. Whether it's commercial, market access, operational, or R&D, what matters moving forward is that we demonstrate results. As we look to our path forward, it's important to acknowledge the meaningful and important results we are delivering. Following the third quarter, we have now reported five consecutive quarters of positive cash flow. This has been achieved through tough but net decisions to reduce headcount and operational expense, as well as ongoing discussions with supply partners to renegotiate supply agreements. Today, we have $320 million in cash on hand, an increase of $15 million versus Q3 2022 and no debt. whilst our European business has not delivered what we have expected to date. And we know we need to do more. We are encouraged by the focus and impact of our new leadership and team is demonstrating and by early progress from initial launches in key countries. Fundamentally, we are confident in our European opportunity given our IP position with the potential to have protection up to 2039. We will discuss this in more detail later in the call. November marks three years since the first generic entrance in the US. Despite this challenge, our team has extended the lifecycle and market leadership of ASEPA, maintaining 57% market share. The durability of this business has been extended by sustained investments in managed care and trade capabilities, despite the elimination of the US sales force. In the rest of the world, overall, we are at early stages of expansion via partnerships. Whilst we have revenue from partners in Canada and the Middle East, we have tremendous opportunity in key markets such as China, as well as Australia and New Zealand. Notably, China launched the very high triglyceride indication in September and submitted its filing for cardiovascular risk reduction last week. Recently, we discussed the progress to date and path forward with our board of directors. In those discussions, it was clear that the best path forward for Ameren today is to remain focused on accelerating operational momentum. In Europe, our teams will continue to be focusing on key launches, including the UK, Netherlands, and Spain, while also continuing to advance pricing and reimbursement efforts in a number of markets, particularly Italy, France, and Germany. In the US, we'll continue to support our business through targeted efforts, including managed care and trade initiatives to secure exclusive contracts. And in the rest of the world, we'll continue to support our partners to get our product into the hands of as many patients as possible. We believe this focus on operational momentum will maximize shareholder value and position us for future strategic options. Moving to Europe, our teams continue to work to deliver both pricing and reimbursement as well as commercial progress in a region which is challenging for the entire industry. From a commercial perspective, whilst it remains early in the commercial launch process in key countries, we are beginning to see initial signs that our local country strategies are working. In the United Kingdom, first, it's important to note that this is traditionally a slower uptake market. This is driven by a number of factors, but mainly the complex healthcare system in the market. Whilst the team faces that challenge, they have successfully unlocked all formularies within the first few months post-launch in England and Wales. We now have a more focused strategy in place, including driving uptake in key accounts that is delivering now more than 30% quarter-over-quarter pharmacy sales growth. In Scotland, following recent reimbursement approval, the team is progressing access to formularies. In Spain, our commercial team is focused on HCPs who are early adopters of cardiovascular products, and we are seeing promising yet early sales across all regions, We now estimate 500 patients are on therapy one month post-launch. And in the Netherlands, our team is executing on a focus strategy based on identified key accounts to drive adoption. This is backed by extensive local market research. We now estimate more than 100 patients are on therapy one month post-launch. On the pricing and reimbursement front, we have now secured pricing and reimbursement across nine countries in Europe, including Spain, the Netherlands, and Scotland in the third quarter. This continued pricing and reimbursement progress strengthens the foundations for VASCEPA in additional markets where we are seeking pricing and reimbursement decisions. In Italy, Ameren has finalized a new path forward to pursue market access for VASCEPA by the end of 2024. In France, we are progressing a new access strategy for Vesca with the national authorities. We do not expect this process to conclude in 2024. And in Germany, we are continuing to evaluate potential options to secure pricing reimbursement for German patients. We will share more on Germany in the coming quarters. In terms of other markets where we have ongoing pricing and reimbursement processes underway, we do not expect to receive additional decisions in 2023. We remain confident in our path forward in Europe, particularly given our intellectual property in the region. We have regulatory data protection in Europe until and we also have patents and applications that have the potential to extend our IP well into the decade, indeed potentially up to 2039. Turning to our US business, November marks three years since the launch of the first generic IP into the market. As we all know, most generic markets quickly erode the brand in the United States. As we sit here today, Branded BESIPA continues to hold market leadership with 57% market share and 43% of all Part D lives covered in the US. This market leadership and the work done by a US team to extend the lifecycle of the product has continued to deliver the revenues needed to sustain our business and bolster our financial position. In the third quarter, we had net product revenue of $62.4 million, which is stable versus the second quarter of 2023. We have achieved this by being very efficient with our U.S. operations, sustaining our investments in managed care and trade efforts to support our exclusive contracts, which continue to represent approximately 75% of the U.S. business. Our focus in the U.S. is on continuing to maintain and extend the lifecycle of the Vespa branded business. With that said, aligned to our strong supply position, and as we have stated previously, we stand ready to execute different aggressive scenarios, including the potential future launch of an authorized generic in order to retain market leadership of the IP market. These scenarios are centered around preserving our profitability and of course, our cash. Turning to the rest of world, our approach is focused and clear, that is to expand via partnerships to bring the unique value of our product to maximize the number of patients globally on therapy. We have continued to make progress in our strategy by supporting the efforts of existing partners to deliver market access and by securing agreements with new partners. Beyond partnered markets, we are in the second year of a three-year plan to submit and obtain regulatory approval in 20 or more additional countries and regions to ensure that patients in the top 50 cardiometabolic markets worldwide can benefit from our product. From a commercial perspective, our partners are continuing to make significant, yet early progress as well. In China, the second largest cardiovascular market globally, Amarin's partner, Edding Farm, launched the Cepha in October for the very high triglyceride indication. Edding has also submitted its regulatory filing for a potential indication for cardiovascular risk reduction. It's important to note that this filing has been submitted with a clinical waiver, meaning that an additional regulatory study will not be required to review the new indication. The company is now awaiting the agency's acceptance of that filing. From a partnering perspective, in the third quarter, we signed an exclusive agreement with Lotus Pharmaceuticals to commercialize VASCEPA across 10 countries in Southeast Asia and South Korea. We also signed an exclusive commercialization agreement with Nirofarm for VASCEPA in Israel. In each of these markets, as well as Australia and New Zealand with our partner CSL, Seqirus, regulatory market access and pre-launch activities are well underway. In summary, we are making progress in our efforts to get our product in the hands of as many patients as possible around the world. Our team is doing this with a core focus on operational momentum and with a tremendous sense of urgency to accelerate that progress. We believe this is what will create shareholder value. We are listening to and we appreciate the input from our important retail and institutional shareholders. Now, I'd like to hand the call over to Tom Riley to review our third quarter 2023 financial performance. Tom?