Amarin Corporation plc

Welcome to Amron's Corporation conference call to discuss its third quarter 2020 financial results and operational updates. This conference's call is being recorded today, November 5th, 2020. I would now like to turn the conference over to Elizabeth Schwartz, Senior Director of Investor Relations for Amron. Please proceed.

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, our current expectations regarding our commercial and financial performance, including levels of the SEPA prescription, the SEPA product and licensing revenues, cost, gross margin, and other commercial metrics. Our current plans and expectations regarding spending, including expenditures for promotion of the SEPA and for purchases of additional supply of the SEPA. Our current expectations regarding the adequacy of our financial resources. Our current plans and expectations for product revenue growth, salesforce productivity, and product promotion in light of COVID-19 and the potential for added attention to cardiovascular risk reduction drugs like the SEPA as a result of COVID-19. Our current plans and expectations related to patent litigation and expectations related to the potential loss of generic versions of the SEPA by generic companies and by ourselves. Our current expectations for regulatory reviews outside the United States regarding the SEPA approval. Our goals regarding the timing, scope, and success of international expansion including expectations regarding our ability to launch the CIPA in Europe and our expectations in China for clinical trial results and potential to bridge reduce it results in labeling and promotion of the CIPA through our partner in China. Our current plans and expectations regarding the CIPA exclusivity outside the United States including Europe and China. Our current plans for commercial expansion in the United States with and without entry of potential generic competition and Our current plans and expectations regarding clinical study of the SEPA related to COVID-19. These statements are based on information available to us today, November 5, 2020. 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 annual report on Form 10-K for the year ended December 31, 2019 and the Forum 10Q filed for the quarter ended September 30th, 2020. These documents have been filed with the SEC and are available through the investor relations section of our website at Amerincorp.com. We encourage everyone to read these documents. This call is intended for investors in Amerin and is not intended to promote the use of the SEPA outside its approved indication. An archive of this call will be posted on the Amerin website, also in the investor relations section. Making prepared remarks on today's call will be John Farrell, President and Chief Executive Officer, Craig Granowitz, Chief Medical Officer, and Michael Kalb, Chief Financial Officer. After prepared remarks, we'll respond to questions. Some of you submitted questions in advance and were practical. We have tried to cover responses in our prepared comments. I remind you that typically listening to calls of this nature are multiple audiences, including existing investors, potential new investors, Employees, Regulatory Authorities, 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 will now turn the call over to John Tharo, President and Chief Executive Officer of Ameren. John?

Good morning and thank you for joining us. As we announced in our press release earlier this morning, Amarin reported record revenue in the third quarter. Since our last investor conference call, we made progress across a number of areas key to our growth strategy, including advancing our plans for commercial launch of Vaseepa in Europe, increasing promotion of Vaseepa in the United States, and publication and presentation of several robust data sets in support of Vaseepa's demonstrated cardiovascular risk reduction and multifactorial mechanisms of action. Turning to our revenue, we achieved a year over year total net revenue increase of 39% in the third quarter and 56% for the first nine months of 2020. The 39% growth in the third quarter represents significant growth from the second quarter, but remains below the greater than 100% year over year growth reported in the first quarter of 2020 Thank you for joining us. We've all faced with the COVID-19 pandemic. Based upon TRX data from Symphony Health, the SEPA growth during the third quarter and year to date continued to outpace the growth rates for more established drugs with positive cardiovascular outcomes data, such as statins. Moreover, the SEPA's growth in these periods also outpaced the growth of nearly all branded drugs for which positive cardiovascular outcome results were reported within the past four years. While vasepa does not compete against these other drugs, we are proud that in these challenging COVID-19 times, and despite commercial spending to promote vasepa being lower than spending for many such drugs, vasepa's growth exceeded that of such peer drugs. After the impact of COVID-19 becomes less pronounced, we expect that Vespa prescription growth will accelerate. In July, we initiated our first direct consumer promotion of Vespa for cardiovascular risk reduction in the United States. The goal of this promotion is to increase awareness of Vespa and to encourage at-risk patients and healthcare professionals to inquire further about the SEPA. While the impact of any such promotion is typically not immediate, we believe it is important and it will help because recent survey data suggests that just 32% of physicians and less than 1% of at-risk patients were aware of the SEPA as a proven therapy for cardiovascular risk reduction. This is not surprising We believe the potential for even greater growth justifies our continued investment in expanded promotion for VSIPA despite expectations for future generic competition. which leads me to comments regarding potential competition from generics companies. As you know, we are very disappointed that the federal circuit upheld the district court's earlier patent decision. On November 4th, 2020, our rehearing and en banc petitions were denied. We plan within 90 days of such denial to ask the US Supreme Court to hear our appeal. We believe the courts were wrong in their decisions and we will continue to pursue this matter although we cannot provide any guarantee of success in this pursuit. Unfortunately, the decisions were not only wrong for the reasons we articulated in our litigation but they also have the effect of harming patient care in the United States as fewer patients may ultimately benefit from VSIPA. As a reminder, the patent loss for VSIPA is only in the United States and relates only to the niche vasepa indication approved in 2012 triglyceride lowering in patients with severely high triglyceride levels which is defined by the FDA approved label and by medical guidelines as triglyceride levels greater than or equal to 500 milligrams per deciliter. Importantly, such patents are not related to Vesipa's more recently approved indication for cardiovascular risk reduction for which over 90% of Vesipa prescriptions in the United States are written. Typically, even when generic companies have so-called skinny labels, meaning labels that in one way or another communicate less than a brand's full label, brand companies typically experience a more complete loss of sales. We thank the many investors who sent us constructive suggestions on our legal options. Know that we have been tracking the GSK versus Teva case for some time. The legal team representing GSK at trial and on appeals substantially overlaps with the legal team that represented Ameren before the federal circuit. and the attorneys that submitted a brief for pharma on appeal in GSK versus Teva represented us at trial and on appeal. We do not intend during this call to get into further detail regarding our legal strategy or interpretations of case law in this area. Doing so could be counterproductive to our interests. As in the past, we refer you to our current and future disclosures in our 10Q, to court filings, and to the frequently asked questions section of our corporate website, which we plan to continue to update periodically as events develop at Ameren. Typically generic products enter markets where branded products have been promoted for a decade or longer, and such products are well understood by the applicable medical and patient communities. The Cardiovascular Risk Reduction Indication for VSIPA was launched in January of 2020. We have only begun educational and promotional initiatives for VSIPA with respect to this broader and very important indication. Undoubtedly, Ameren ceasing initiatives to educate and promote VSIPA for cardiovascular risk reduction is not in the best interest of patient care are not anticipated to replace such initiatives with broad public education or promotion. Without significant public educational and promotional initiatives, many healthcare professionals and at-risk patients who should learn about Bacepa's proven effectiveness may never do so. In such a scenario, the significant reduction in heart attacks, strokes, and cardiovascular death We believe that increased promotion and education on the cardiovascular risk reduction indication will build market share for branded vasepa, even with generics in the market for the narrower label of triglyceride lowering. While Ameren's continued educational and promotional initiatives in the United States are clearly best for patient care, we also believe that such initiatives are best for Ameren shareholders. Together with our advisors, we have conducted extensive analysis of the potential value to Ameren of continuing initiatives to expand the use of the SEPA in the United States compared to launching our own generic version of the SEPA. The results of this analysis overwhelmingly favor continuing our educational and promotional initiatives of the SEPA to grow the market. Unless our assumptions change significantly, we intend to continue with all such forms of initiatives including direct sales and direct to consumer promotion. We are aware that we will likely lose some portion of Vesipa prescriptions in the United States to generic versions of Vesipa, but we're confident that with continued promotion, we can build the market. The need for Vesipa in the United States is large, and we aim to grow the market faster than generic companies can take meaningful market share due to anticipated generic manufacturing capacity limitations and associated time and costs for them to supply the market. As we continue to grow the vasepa brand in the United States, we are also advancing this important product in countries around the world where we see a myriad of opportunities to benefit at-risk patients while building the vasepa franchise. In Europe, regulatory review by the European Medicines Agency continues to progress. We look forward to Vaseepa becoming the first and only cardiovascular risk reduction therapy for patients with persistent cardiovascular risk. We continue to expect approval of Vaseepa in Europe in early 2021. There is a large and growing opportunity for Amarin to bring this potentially life-saving therapy to millions of patients throughout Europe at high risk for cardiovascular events. 3.9 million Europeans die annually of cardiovascular disease, representing approximately 45% of all deaths, and over 49 million Europeans have cardiovascular disease. A recent survey shows that about 25% of a representative sample of more than 7,800 patients in 27 European countries with coronary heart disease and controlled LDL cholesterol levels had elevated triglyceride levels greater than 150 milligrams per deciliter, illustrating the potential pervasiveness of high-risk cardiovascular disease in Europe beyond currently available therapies. For purposes of context, there are 44 million patients on statin therapy in the European Union, including 32 million statin-treated patients within the five largest markets. of the European Union. This compares to approximately 38 million statin-treated patients in the United States. As we have pointed out in the past, not every statin-treated patient is indicated for VSEPA. However, these statin patient numbers suggest that the size of the opportunity for VSEPA in Europe is comparable to the size of the opportunity in the United States. This represents a multi-billion dollar market opportunity for VSIPA in Europe. As described previously, our analysis reflects that self-launching in Europe, rather than licensing a substantial portion of the upside to a third-party company, allows us to create the greatest value for Ameren. In doing so, we will be leveraging our in-depth knowledge of the science and clinical data without incurring royalty costs for third-party support in most countries. Towards that end, we are making great strides in building our team and finalizing our go-to-market strategies. In July, we were delighted to welcome Karim Mikhael to the Ameren team to lead our commercial efforts in Europe. Karim is making tremendous progress building off the work we have done over the past year to prepare for commercial launch in Europe. He is actively recruiting an exceptional cross-border team and preparing for medical access negotiations, which we plan to more formally begin on a country-by-country basis after POSIPA is approved in Europe. As you are aware, there has been a resurgence of COVID-19 in Europe. At this time, we do not anticipate COVID-19 to significantly delay the regulatory approval of POSIPA in Europe. While we are experiencing some headwinds from COVID-19, In our commercial planning, hiring, and execution regarding commercialization of VSIPA in Europe, considerable progress is being accomplished. Our commercial planning assumes that the impact of COVID-19 subsides significantly by the time that we get through the reimbursement processes in many countries. We are assuming that digital promotion will need to be an important part of our promotional and educational initiatives for VSIPA in Europe. Launching of Vaseepa in Europe compared to launch in the United States where Vaseepa was launched for treating very high triglyceride levels will be for a much larger indication, the cardiovascular risk reduction indication, with demonstrated outcomes, trial results, and no direct competition. In addition, launch in Europe will be aided by the fact that Vaseepa is already indicated in the medical treatment guidelines of the European Society of Cardiology, ESC, and the European Atherosclerosis Society, EAS. Notably, in September 2020, the ESC expanded their guidelines to also include patients with acute coronary syndrome. As we launch POSIPA in each country in Europe, while we intend to do this in a staged manner gated by the timing of payer access, we intend to do so robustly. Our primary emphasis will be on educating specialists, particularly cardiologists, about the SEPA, although we also intend to target other specialists like endocrinologists and select general practitioners. In Europe, compared to the United States, a greater proportion of statin treated patients see cardiologists, which should create some relative efficiency in our promotion. both because of the greater concentration of at-risk patients and because cardiologists tend to be more data driven. For example, in the United States, cardiologists have been the fastest group of physicians to increase vasepa prescriptions following the positive results of the reduced cardiovascular outcome study. I do not want to suggest that with approval of vasepa in Europe, that growth will be immediate. As you are likely aware, Payor access in Europe needs to be negotiated on a country-by-country basis, and this requires time. Ameren currently is taking preliminary steps to prepare for such access negotiations. Until such access is secured, in most countries of Europe, it would be futile to launch. However, unlike in the United States, where when Visipa was launched, reimbursement needed to be built on a payer-by-payer basis, In most countries of Europe, once the reimbursement is established, physicians do not have to worry about managed care surprises, which in the United States makes some physicians reluctant to prescribe new drugs. We will comment further on our plans for VSIPA in Europe after the drug is approved and we have further advanced our market access initiatives. In parallel to our efforts to prepare for commercialization of VSIPA in Europe, Our medical affairs and research and development teams continue to present compelling data which is gaining attention of thought leaders throughout the world. To discuss more of our progress in these areas, I now turn the discussion over to Dr. Craig Granowitz, our Chief Medical Officer.