Amarin Corporation plc

Welcome to Ameren Corporation's conference call to discuss its third quarter and nine month 2021 financial results and operational updates. This conference call is being recorded today, November 3rd, 2021. I would like to turn the conference call over to Michael Kolb, Chief Financial Officer 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 by the Private Securities Litigation Reform Act. Examples of such statements include, but are not limited to, these statements are based on information available to us today, November 3rd, 2021. We may not actually 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 factors that could cause actual results to differ materially, Please see the risk factors section of our quarterly report on Form 10-Q for the quarter ended September 30, 2021, and our annual report on Form 10-K for the year ended December 31, 2020, which have been filed with the SEC and are available through the investor relations section of our website at www.amroncorp.com. We encourage everyone to read these documents. This call is intended for investors in Amron and is not intended to promote the use of a SIPA. An archive of this call will be posted on Ameren's website in the investor relations section. Karine McHale, Ameren's president and chief executive officer, will lead our discussion and I will provide a more detailed review of our financial results. After prepared remarks, we will open the call to your questions. I remind you that multiple audiences typically listen to calls of this nature, including existing investors, potential new investors, employees, current and potential collaborators, and current and potential competitors. As always in this call, we will attempt to provide constructive information without compromising our competitive and strategic positioning. I now turn the call over to Karim Mikhael for a view of the business.

Good morning and thank you all for joining us this morning. The third quarter of 2021 was a critical quarter for Ameren as we continue to make important strides toward our goal to bring the SEPA, the SCEPA and its CV risk reduction benefits to at-risk patients around the world. These advances were led by the meaningful progress we made commercializing Vaskepta in Europe, as highlighted by our successful product launch in Germany in mid-September. This was followed by the announcement of our transformative go-to-market strategy in the US, which underscores our commitment to the US market, and it's designed to enhance awareness and drive demand for branded vasepa and the cardiovascular risk reduction indication. Last quarter, when I had just taken over the CEO position, I shared with you the vision for our three-dimensional growth strategy, breadth, geographic expansion, height, representing diversification, and depth or operational evolution. Today, I'm happy to report on the progress we've made executing the strategy. including a number of milestone achievements demonstrating that we are well on our way to become the global cardiometabolic commercial player we envision. Let me begin with a brief review of our results for the third quarter. Starting with our revenue, as you saw in our press release this morning, we reported net total revenue for the third quarter of 2021 of $142 million compared with 156.5 million dollars in the same period in 2020. We reported net total revenue year-to-date of 438.7 million dollars compared with 446.8 million dollars for the first nine months of 2020. The bulk of this revenue is from U.S. product sales of Vesipa. Importantly, and as Mike will discuss later in the call, our U.S. Vesipa franchise remains profitable and along with our strong balance sheet continues to support our growth and expansion plans. Now for a deeper dive into the U.S. market. This has been a particularly challenging quarter as a number of market and competitive dynamics impeded the potential for growth in the U.S. First, the impact of the resurgent COVID-19 Delta variant caused patient visits and lab visits to drop by 6% and 7%, respectively, compared with the prior quarter. Additionally, the lipid market flattened for the first eight weeks of the quarter. Finally, and for the first time, there were two generics available on the market for an entire quarter. These dynamics created both the need and the opportunity to reevaluate our strategy. So let me walk you through our thinking. We needed to better understand the key gating factors to building more significant adoption of the SEPA for its cardiovascular risk reduction indication and to develop a plan to tackle them. Perhaps the biggest rival for growth is improving physician access and engagement. Long before the COVID-19 pandemic hit, access to physicians was on the decline. For example, according to ZS Access Monitor, access to physicians in 2007 was approximately 80 percent or four out of five by the end of 2019 that access had fallen to about 50 percent during the early days of the quarantine in 2020 those levels were at mere seven percent and they currently stand at only 29 percent in other words less than one out of three physicians on average is accessible for visits by the field force our new strategy employs a digital omni-channel approach to enhancing our reach to healthcare professionals allowing us to target a far greater number of the almost 700 000 statin prescribers through high frequency customized and impactful messaging regarding the significant benefits of the SEPA for cv risk reduction simply This creates a model of engagement with prescribers in the ways they want. We intend to significantly increase the use of these robust digital platforms and integrate them with in-person visits by our sales force to enhance our reach and customer engagement and improve efficiencies optimizing our educational and promotional efforts to drive healthcare provider and patient use of branded vesipa in the US. These digital platforms include a variety of offerings such as virtual detailing, email campaigns, websites and medical portals, digital CMEs, social media, and more. Our next area of focus is managed care. While several large commercial and Medicare Part D payers currently cover the SEPA as the exclusive icosapent ethyl product, We are intensifying efforts to remove remaining barriers to the SIPA prescription to improve access to patients with real medical need. We are confident in our ability to drive further volume growth by continuing to focus on enhancing payer access. Finally, our last equally important area of focus is to clarify the difference in approved indications between the SIPA and the generics. Generics are not FDA approved for cardiovascular risk reduction. We are taking a variety of steps to eliminate confusion created by the limited indication of the generics and educate the market regarding the substitution of the SEPA with generics for non-indicated uses, particularly at the pharmacy level. Our goal is to continue to correct factual inaccuracies within the total prescribing ecosystem. from the references compendia to retail pharmacy systems to e-prescribing platforms used by physicians in order to reduce substitution for non-indicated uses and minimize any disruption in patient care. Correcting these systems is a complex process and it will take some time, but we are making progress and we expect that we can make a significant difference in keeping genetics usage within their narrow approved label. for all the above. At the end of September, we announced what we believe will be our transformative go-to-market strategy, which underscores our commitment to the U.S. market and addresses three key areas for improvement, expanding physician engagement and access, enhancing managed care access, and optimizing the SEPA prescription for CV risk reduction. Our goal is to deliver a simple, streamlined platform to manage end-to-end slow prescription and to ensure an optimized patient and prescriber user experience. While these new go-to-market initiatives are in the early days, we will be driving their implementation with a focused sense of purpose while tracking and re-evaluating our decisions. We have three measurements for success. Execution, did we successfully and urgently implement these initiatives? strategic impact, did they deliver their expected impact, revenue, and ultimately did these initiatives produce greater patient and provider usage resulting in prescription and revenue increases. We are confident that this new go-to-market strategy will be successful by all measurements and look forward to reporting more on this front as it unfolds. We also continue to consider and entertain numerous strategic initiatives which, if feasible and successful, could allow us to further differentiate versus the generics. While in early stages, we believe that such efforts aimed at truly differentiating ourselves versus generics would have a significant impact on the future potential of the SEPA in the US. Turning now to our progress in Europe. During the third quarter, Ameren demonstrated its commitment to becoming a global commercial player with its launch of VSCEPA in Germany. As a reminder, when Ameren announced in August 2020 that it would self-launch in Europe, we had no legal entities in Europe beyond Ireland, no infrastructure and no commercial presence. We did not even have a regulatory approval for VSCEPA. Today, just a little over one year since that announcement, We have an EMA approved label that is totally consistent with the broad patient population of Reducit. We have 15 legal entities and branches, including a commercial hub in Zug, Switzerland, 300 employees, and have executed our initial commercial launch in Germany. We are especially pleased that our teams were able to launch in Germany on such an expedited schedule. The launch debited with a successful scientific conference that was led by 11 internationally renowned cardiovascular specialists and was attended in person by more than 200 healthcare professionals from Germany with a live stream to many more physicians across the continent. The medical and commercial teams have made great strides introducing the cardioprotective benefits of Vescapa to the German market with 60 events hosted to date and more than 50 events approved and ready to execute before year end. This is a very proactive plan and our team is making every effort to reach our target audience both physically and virtually as access to physicians and hospitals in Germany is still limited due to COVID. In these early days and for the next couple of quarters, we believe the best proxy for a successful launch will be illustrated by the scientific endorsement from the key thought leaders and top societies and our ability to engage, educate and promote the SCIPA to our targeted audience. We are pleased to report that the SCIPA has been included in Germany's electronic prescribing system, which is updated quarterly effective October 1st. This is an important step in making the SCIPA more readily accessible as paper prescriptions represent a very small portion of total prescriptions today. We were honored to be one of three finalists for the Gallinus von Pergamon Prize or Prix Gallien in Germany, a prestigious scientific prize awarded for a particularly innovative medicinal product that has been approved in Germany at the time of submission. This year's prize went to Biontech Pfizer for their COVID-19 vaccine. So we are truly honored to have achieved the second place and we have been widely recognized for this achievement in the German press. Now on a European regional level, we previously communicated that our goal is to file 10 market access dossier by year end and I'm proud to report that we have already submitted all 10. This really allows Ameren to initiate the negotiation process with the reimbursement agencies of the largest 10 markets in Europe. Those markets are Germany, UK, Italy, France, Spain, Denmark, Sweden, Finland, Norway and the Netherlands. We have already engaged extensively with several of these countries and in our next earnings call we will provide an update on our exchanges and expected timelines for reimbursement approvals. I can also confirm that all 10 submissions included data demonstrating the uniqueness of Baskepa from a scientific perspective, various country-specific demographic data to define the eligible patient population based on the label, and the same targeted list pricing of approximately 200 euros or $240 monthly. The next wave of country submissions is being initiated now and will include five additional countries in Europe. We have also initiated the first steps to identify the partner or partners we plan to collaborate with in the Central Eastern Europe countries starting with Greece. Over the past year, we have been prudent yet agile, fast and at the same time measured in how we have built investments and infrastructure in Europe. We are prioritizing and structuring our markets organizations in a focused way driven by our belief that a tremendous opportunity exists to change the treatment paradigm in preventative cardiovascular care across Europe. Beyond Germany, in the vast majority of our targeted markets, we are in the important pre-launch phase, which means that we are establishing relationships with healthcare professionals, providing education on the cardioprotective benefits of the SCIPA and negotiating market access. Our digital first strategy and the capabilities we've developed implementing it allow us to quickly navigate and access our customers differently while complementing all of our field force efforts. We recognize that not all markets are the same and our approach to each must be tailored and bespoke. The technology behind our customer engagement ecosystem allows us to have an aligned commercial model that can be easily adapted to the specificities of the individual market and enables us to successfully integrate our digital and face-to-face channels in one single cross-functional plan. We are very excited about the opportunity for Vescapa in Europe. As CBD is an increasingly common health problem that causes 3.9 million deaths per year in Europe and costs the European Union 210 billion euros every year. Our mission to rethink the treatment of residual cardiovascular risk across Europe is no small feat, but we're up for the challenge. We are committed to improving the lives of high risk cardiovascular patients across Europe by establishing a new treatment for CVD. Setting a new standard in cardioprotective care won't happen overnight. However, we have a high level of confidence that we've got the drive, the scientific evidence, the strategy, and the people to make it happen. Beyond the significant multi-billion dollar market potential in Europe, let me turn to the other international opportunities we are pursuing. Last quarter, we announced our ambition to bring the cardioprotective benefits of the SEPA, the SCEPA, to the top 50 cardiometabolic markets worldwide. We currently have access to approximately 30 of these markets and have now mapped our strategy to obtain access in the other 20. Our plan will take place in three waves. The first will begin in 2022 when we plan to submit regulatory filings and obtain product approval in up to six countries, including Australia, New Zealand and Israel. The second wave will come in 2023. when we will seek approvals in up to nine countries. The third wave follows in 2024 when we will be seeking approvals in the remaining five countries we have targeted. These filings will all be supported by long-term cardiovascular outcome data from the REDUCE-IT study and the FDA and EMA approvals of the SEPA, the SCEPA for the cardiovascular risk reduction indication. We will be specifically seeking our EMA broad-level language in all of these countries. In most of these markets, we will potentially opt for an agency-distributorship partnership. Such collaborations have the advantage of giving us control over the marketing authorization of our product and providing optionality as we grow the business globally. We believe expanding the Ameren reach to these additional 20 markets has the potential to benefit millions of patients at risk of a CV event and represents a market opportunity of around $1 billion. Moving on to other international markets where we already have partners. In China, our partner Edding continues to expect to receive approval of the CIPA in mainland China and Hong Kong near the end of 2021. With these approvals, Edding has plans to launch in these territories in 2022. As in the US and Europe, Vesipa will launch with the support of the two key Chinese cardiology societies. With the burden of CV disease in China and with two branded statins collectively selling more than $1 billion, there is both a significant medical need and a meaningful market opportunity for Vesipa in China. In August 2021, our partner in Canada, HLS Therapeutics announced a promotional agreement with Pfizer expanding promotion of Vesipa to primary care physicians in Canada. HLS existing sales force of approximately 30 field personnel and support staff will remain primarily focused on the specialist physician audience. We believe this new agreement should bode well for Vesipa in Canada as the primary care physician market is a good gateway to patients at risk for CVD and the Pfizer name is well respected and known for excellence in the pharmaceutical industry. Finally, let me share some perspective on our thoughts around diversification, the high dimension. We continue our systematic review of all potential assets in the cardio metabolic and obesity space. We are not limiting ourselves to those that lend themselves to primary care and large populations alone. We're also considering unique assets including in the specialty and rare diseases spaces where there remains tremendous unmet need. We are prioritizing two types of assets, assets with near-term commercial potential and development stage assets that have the potential of significantly enhancing and transforming our portfolio. As you can appreciate and due to our primary focus on the cardiometabolic space, This process requires time in scientific, commercial, and financial diligence. We are dedicating the needed resources and continue to believe that this is an important leverage for future growth. With this overview of our business, let me turn the call over to Mike Cobb, our CFO, for a more detailed discussion of our financials. Mike?