Amarin Corporation plc

Welcome to Ameren Corporation's conference call to discuss its first quarter 2022 financial results and operational updates. This conference call is being recorded today, May 4, 2022. I would like to turn the conference call over to Lisa DeFrancisco, Senior Vice President, 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 by the Private Securities Litigation Reform Act. 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 factors that could cause our actual results to differ materially, please see the risk factors section of our annual report on Form 10-K for the year ended December 31st, 2021, and our Form 10-Q for the quarter ended March 31st, 2022, which have been filed with the SEC and are now available through the investor relations section of our website at www.investorrelations.com. We encourage everyone to read these documents. This call is intended for investors in Ameren and is not intended to promote the use of the SEPA. An archive of this call will be posted on Ameren's website in the Investor Relations section. Karim Mikhael, Ameren's President and Chief Executive Officer, will lead our discussion. Dr. Steve Ketchum, President of R&D and Chief Scientific Officer, will provide an update on our FTC program as well as recent clinical data and publications And Mike Kalb, Amherst's Chief Financial Officer, will provide a more detailed review of our first quarter 2022 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 positionings. I'll now turn the call over to Karim Mikhael, President and Chief Executive Officer of Ameren.

Thank you, Lisa. Good morning, and thank you all for joining us today. We enter 2022 noting that this is a year of execution for Ameren, and to date, we have accomplished important milestones and are on track to achieve the goals we have set for the year. 2022 thus far for Ameren is marked by progress across all three pillars of our growth strategy, breadth or geographic expansion, height representing diversification, and depth or operational evolution. Before I discuss the considerable progress we are making in Europe and across our business, I want to touch on our results this quarter and the dynamics we are facing within our US business. we recorded $94.6 million in total net revenue, including $93.5 million in U.S. product sales during the first quarter of 2022, a decline from both the same period in the prior year as well as the prior quarter. The results were impacted by the launch of a third generic entrant, which disrupted the market considerably at the wholesaler level. and resulted in lower volume as well as lower average net selling price as we focused our efforts on securing exclusive business in the face of this additional generic competition. The decrease in volume for VASIPA sales was predominantly due to Ameren customers in the United States who have not availed themselves of competitive pricing programs and exclusivity. In addition to the generic market disruption, the decrease in revenue was exacerbated by the first quarter seasonality we typically experience with beginning of the year deductibles under patient insurance plans. Mike will discuss these dynamics in more detail shortly. While our U.S. revenue is currently supporting our growth strategy, we are very aware of the challenges we face with additional generic competition. We continue to vigilantly monitor key performance indicators in this market to support our strategy moving forward, including generic penetration rates, market supply, and icosapent ethyl market growth, among other metrics. Importantly, as we are closely monitoring the market dynamics in the U.S., including prescription trends, we have not seen an acceleration of total generic penetration with the third entrant on the market. Our goal is to offset these challenges with a focus on operational excellence, where we have identified and began implementing an approximately $30 million reduction in annual marketing expenses. With these initial savings and future potential efficiencies, it is our objective to maintain our positive contribution margin defined as U.S. gross profit less US sales and marketing-related expenses. In the US this year, while we focus on gaining pricing and reimbursement to set the right foundation for sales in Europe and for expanding our international business over time, noting that our global growth strategy in its initial stage We believe we are making headway in the U.S. with our go-to-market strategy, and we continue to focus on stabilizing the SIPA revenue with this focused approach, which includes expanded provider engagement, optimized fulfillment of the SIPA prescriptions for CV risk reduction, and enhanced managed care access. As of March 31, 2022, through our offerings designed to be competitive with the current market landscape, We expanded coverage to approximately 45% of the total commercial and Medicare Part D lives on a weighted average basis with the SEPA as the exclusive IPE product. We believe that although these arrangements do have an adverse impact on the average net selling price, they may support greater volume stabilization of the business over the medium and longer term, which is one of our key objectives. Our ongoing efforts to expand provider engagements have been progressing. We are seeing the benefits of our digital omnichannel efforts, which are giving us great insight into the prescribers and how best to reach and influence them. We are using these tools to reach our target audience of physicians who treat prior MI patients and the doctor who currently prescribed fibrates for their patient at risk for CV event. In addition, Our prescription fulfillment optimization strategy is progressing with our BlinkRx partnership, which has provided early wins as we begin to implement this program. We're also encouraging the use of Dispense as Written, or DAW, through in-person and digital initiatives to ensure patients receive branded VSIPA when prescribed for CV risk reduction indication. Lastly, we have had some recent and significant developments that I would like to highlight. As you know, we are optimizing fulfillment of the CIPA prescription for CV risk reduction with a new campaign focused on prior myocardial infarction patients at a heightened risk of a subsequent event. Supporting this campaign is the compelling data from Reduce-It that shows the CIPA reduced CV events by 35%, in prior MI patient. The benefits of the SEPA in these patients who have experienced a heart attack and are at risk for another cardiovascular event are particularly important given these patients are at elevated risk of recurrent CD problems. These results further strengthen the case we are making to physicians. who care for these high-risk patients for pure EPA in the form of prescription icosapent ethyl as a key intervention beyond statin for meaningful risk reduction. Another area for continued focus comes very recently following the announcement of discontinuation by another pharmaceutical company of their study Prominent, which looked at a new Fibrate for CV risk reduction. As many of you know, as a result of previous failed cardiovascular outcome trials, the FDA revoked the approval of phenofibrates to manage CV risk back in 2015 after concluding that they should not be used in combination with statins because the risks outweighed the benefits. This latest study discontinuation is further evidence that the fibrate drug class does not provide proven CV risk reduction. Important to note that 2 million patients in the U.S. are prescribed fibrates for CV risk with 60% also receiving a statin. It is clearly not well known within the physician medical community that these patients remain at risk. We see this as an opportunity to ensure that patients with high CV risk on statins are aware and should consider the switch to Vaseba. In summary, we will continue to closely monitor the market dynamics in the US where we again have not seen an acceleration of total generic penetration with the third entrant on the market. Now moving to Europe where we have made considerable progress on our strategy. We were delighted to announce our first national reimbursement in Sweden as it kicked off the next stage of our European growth strategy. we were particularly pleased to have Sweden as our first reimbursement as it is known to be at the forefront in the prevention and treatment of cardiovascular disease and with a disclosed price of approximately 160 euros per month or around 180 US dollars. It should also be noted that this pricing in Sweden is essentially a net price with only distribution-related fees deducted. As a reminder, net prices in Europe, especially for chronic treatments, tend to be much lower than US prices. This achievement acknowledges the value of ASCEPA and our ability to demonstrate this value to payers in Europe. We also have clinical and health technology assessment processes and reimbursement discussions progressing across all of the target markets in Europe, where we submitted market access dossiers. including the United Kingdom, Germany, Norway, Finland, France, Italy, Spain, Denmark, and the Netherlands. Turning to the UK, we are having ongoing active work underway with the National Institute for Health and Care Excellence, NICE, and recently received a second appraisal consultation document, or ACD. A second ACD means that the committee was still not able to reach a final recommendation and will require further consultation with stakeholders. Receipt of a second ACD is not uncommon for innovative treatments seeking reimbursement from the national health system in the UK. We continue to conduct constructive, scientifically substantive discussions with NICE and are actively collaborating with all stakeholders involved in this process. Toward that end, we are receiving positive feedback with strong support from the scientific community who wants to ensure that Vaskepa is made available to all relevant patients who are at risk of having a cardiovascular event. It is important to note that, based on our information, we understand that NICE received, in this round of consultation alone, a significant number of formal positive recommendations from experts from across the UK. We expect a final decision later this year and will update you on our progress in this important market. Let me move on to our progress in Germany, where we are on the market with temporary reimbursement. We have started and are in early stages of formal price negotiations in Germany, which entails four to five rounds of negotiations. During these early proceedings, Corrections were requested from GBA due to their scientific and data misinterpretations and misrepresentations, and we are in parallel discussions on how to resolve these. We plan to continue with these corrective efforts and negotiations and are relentless in defending the strength of the long-term outcome data from Reduce-It, with significant support from the major medical societies and the medical community. Our initial sales in Germany continue to be impacted by local market conditions, predominantly the ongoing impact from COVID-19, which had a second peak during the quarter, which experienced a 320% increase in new cases for a total of 19 million cases that affected 25% of the German population and resulted in significant disruption of the activity of the practices and hospitals. Local market conditions in Germany are also affected by newly proposed healthcare austerity measures, which are being implemented as a result of the challenging political situation in Europe, which has impacted our initial sales during this launch period. And beyond Germany, we have important progress to announce in France, where we received a positive reimbursement assessment from French National Authority for Health, or HAS, in France. and that we have started the process of price negotiation. France is a very significant cardiometabolic market where no omega-3 product has ever been assessed positively by HHS. But due to the strength of reduced data, the team was able to achieve this very important milestone. Finally, discussions in Central and Eastern Europe have been impacted by the local political conditions. However, our partnership discussions in Greece which is a key market in the region, are advancing well. Reimbursement discussions are in various stages of progress in the other markets where we have submitted market access dossiers. We remain on track to receive pricing decisions in up to eight countries with plan to launch VASCEPA in up to six European countries this year. We expect to have updates on at least two major markets by our next earnings call. In Europe, it's important to note that we are taking a regional approach to growth and expansion, where our goal is to build a strong, sustainable, diverse revenue stream based on multiple markets, and this has driven our market access strategy to submit our dossiers in 10 countries in parallel. Also remember that the achieved price anchor in Sweden is very positive and is allowing us to evolve our price negotiations in multiple European countries. With this regional strategy and diversity of product launch times and penetration curves, we are confident that we are laying the right foundation to achieve revenue potential in Europe of over $1 billion. Beyond Europe and the US, at the end of last year, we introduced a bold plan to unlock the potential of Vespa internationally. The plan calls for three waves of regulatory submissions for approval, of VASIPA in 20 additional countries in order to ensure that patients in the top 50 cardiometabolic markets worldwide can benefit from VASIPA. Toward that end, we continue to make meaningful progress in the first wave of these efforts. Following the acceptances for regulatory review of VASIPA in Australia and New Zealand, the dossiers have now entered full assessment by the respective national regulatory authorities in these countries. In Israel, the SIPA was accepted for regulatory review by the relevant authority, and our submission is advancing as per local processes. We were also successful in submitting our reimbursement file at the same time to ensure market access for the SIPA in Israel as soon as possible. Biologics, our partner in the Middle East and North Africa, MENA, received the official registration certificate for the Kingdom of Saudi Arabia, KSA, regulatory authority for the treatment of severe hypertriglycemia on March 8th. This first approval in KSA enables the preparation and submission of a variation to seek review and approval for the cardiovascular risk reduction indication. This brings the total of number of countries approved in the MENA region to six, being Saudi Arabia, United Arab Emirates, Lebanon, Kuwait, Bahrain, and Qatar. In Canada, our partner HLS completed negotiation with Canada's Pan-Canadian Pharmaceutical Alliance for the terms and conditions under which the SIPA would qualify for public market reimbursement in Canada. Following these negotiations, HLS signed a letter of intent allowing them to work with all participating provincial jurisdiction to secure coverage from publicly funded drug plants across Canada and for VSIPA to potentially be added to their respective plants. We look forward to an update on their progress in the coming months. Public market reimbursement for VSIPA in a large single payer country like Canada is a validation of the CV risk reduction benefit of the product and underscoring its pharmacoeconomic value. As a reminder, we have agreed to a partnership of HLS with Pfizer, by which HLS will promote to specialists and Pfizer will promote to the large primary care physician group. This signed letter of intent with PCPA will further maximize the value of this partnership with the SEPA being accessible to patients in the public sectors in Canada. Lastly, Our current partnership approval for Vaseepa in Hong Kong for a CV risk reduction indication has been recently received, and a commercial launch is planned for Hong Kong later in the year. The new drug application for Vaseepa in mainland China remains under review by the Chinese National Medical Product Administration, and the NDA includes the previously announced successful results of Phase III studies, including Reduce-It, we believe that a decision can still be expected by the end of this year. Moving forward, we remain confident in the multi-billion dollar global market opportunity for VASIPA and VASCEPA in Europe and internationally and are beginning to see this opportunity come to fruition. Before I turn the call over to Dr. Steve Ketchum, Ameren's EVP, President of R&D and Chief Scientific Officer, to discuss portions of the height or diversification pillar of our core GOES strategy, including our fixed dose combination and recent advancements in our data, I wanted to note that we continue to search for opportunities for business development in the cardiometabolic space while continuing to advance our internal development of a fixed-dose combination portfolio for Vaseba. We also continue to strengthen our leadership team, where I would like to welcome two new members. I'm pleased to welcome David Keenan, a Senior Vice President of Technical Operations, who will be joining us in mid-May and will be based in our Dublin offices, and Dr. Nabil Abadir, Senior Vice President and Chief Medical Officer, who joined us last week and will be based in our offices in Zug, Switzerland, to build a global cross-functional medical organization as we build support for Vespa Vescapa globally. Now, I will turn it over to Dr. Steve Ketchum. Steve?