Amarin Corporation plc

Welcome to Ameren Corporation's conference call to discuss its second quarter and six-month 2021 financial results and operational updates. This conference call is being recorded today, August 5th, 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. Turning to slide two of the presentation accompanying today's call, which can be found in the investor relations section of our website at www.amroncorp.com, 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, August 5th, 2021. 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 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 June 30th, 2021 and our annual report on Form 10-K for the year ended December 31st, 2020. which have been filed with the SEC and are available through the investor relations sections 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 SEPA outside its improved indications. An archive of this call will be posted on Amron's website within the investor relations section. Kareem McHale, Amerind'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 review of the business.

Good morning and thank you all for joining us this morning. I'm particularly pleased to be addressing you for the first time as the President and CEO of Ameren following John Thoreau's planned retirement which officially took place earlier this week. On behalf of the entire Ameren team, I'd like to thank John for his considerable contributions to the company and to patient care around the world. We wish him much success and happiness as he embarks on his retirement following his distinguished career as the President and CEO of Ameren. I joined Ameren as Senior Vice President and Head of Commercial for Europe approximately one year ago because I was attracted by the magnitude of the evidence in the reduced study and excited by the tremendous European opportunity we have to change the treatment paradigm in preventative cardiovascular care. Turn to slide three, please. Developing and commercializing cardiometabolic assets is a daunting mission and many companies stepped away from this space due to two main challenges. First, for numerous indications, you need cardiovascular outcomes data, which take years to generate and are a challenge to fund. And second, in order to ensure that as many patients can benefit from the new CV drug, you need to reach a broad prescribing audience. With the REDUCE-IT study, Ameren has already succeeded in developing the first and only approved medication for reducing cardiovascular risk beyond LDL lowering therapies in high risk statin treated patients. This foundational scientific rigor is the main driver for the consistent recognition of 19 global medical societies with the latest edition of the American College of Cardiology. In terms of broad prescriber reach, Ameren has established a go-to-market model in Europe that allows us to reach larger prescribing audiences through efficient omni-channel engagements that amplify our essential field force efforts and Ameren is leading the way in terms of innovation in this space. Our overarching goal for this exciting and new chapter of Ameren's future is to drive our profitable growth, primarily by unlocking the vast potential of Vascepa to reduce cardiovascular risk worldwide. But before I share with you my vision and our plans for the future, let me first update you on our progress in general and more specifically in the US, Europe and the rest of the world. Turning to slide number four, starting with our revenue growth during the quarter, as you saw in our press release this morning, we reported the net total revenue for the second quarter of 2021 of $154.5 million compared to $135.3 million in the same period in 2020. The bulk of this revenue is from U.S. product sales of the SEPA. Importantly, and as Mike will discuss later in this call, our U.S. the SEPA franchise is profitable and along with our strong balance sheet continues to support our growth and expansion plans. Now more specifically in the U.S., we remain focused on execution and driving the SEPA growth in the U.S. Thank you for joining us today. and or heart disease as well as cardiologists, primary care physicians and pharmacists conducted on behalf of Ameren showed that COVID-19 pandemic has reduced the prevalence of in-person check-ins with healthcare professionals with approximately one-third of the general adult population. Adult diabetes patients and heart disease patients avoiding seeing a healthcare professionals due to the fear of contracting COVID-19. and while in-person visits have increased after the introduction of vaccines, the poll results shows that 62% of cardiologists and 70% of PCPs say that they are seeing fewer patients in person than before the pandemic. As vaccinations take hold in the US and COVID-19 recedes with the hope that market recovery will not be further disrupted by the COVID-19 resurgence, driven by the Delta variant, we see a significant opportunity to generate additional awareness. We never had the chance to build with the pandemic hitting during our first launch quarter and to drive the much needed demand for the SEPA and the cardiovascular risk reduction indication. Due to possible lasting changes that COVID-19 brought to the market, We are planning to achieve our objectives in a different and new way moving forward. While technological advances over the past several years have provided the tools to modernize sales and marketing activities to enhance their impact and efficiency, the COVID-19 pandemic has accelerated the adoption of such technologies and those advances are now playing a central role in pharmaceutical sales and marketing and we believe they will continue to do so after the COVID-19 pandemic is behind us. Moving forward, we intend to significantly increase the use and integration of these robust digital omni-channel platforms to enhance our reach and customer engagement and improve efficiencies as we advance our branded and unbranded educational and promotional efforts to drive HCP and patient use of Branded Vasipa in the US. Turning to slide five, please. To address our unique market challenges in the US, we must engage effectively and efficiently with all four key stakeholders in the market. Firstly, physicians. We continue to inform and reinforce the unprecedented reduced results, the broad managed care access, that branded vesipa is the only available product FDA approved for cardiovascular risk reduction in at-risk patients with elevated triglyceride, that generics do not have an approval for the cardiovascular risk reduction indication, and that the FDA revoked the indication of older triglyceride-lowering classes such as phenofibrates with statin to reduce cardiovascular risk. Secondly, with Peyers, We continue to make inroads with additional favorable managed care wins and enhancements that help to validate the SEPA value proposition in persistent cardiovascular risk. Thirdly, pharmacists. We have been working with major national and regional chains to ensure that CV risk patients obtain proper FDA approved the SEPA. Many of these major chains have confirmed significant difficulties and disruption as a result of limited inconsistent supply of generic IPE. This disruption has not only caused patients to leave the pharmacy without needed medication, but the pharmacy retailers have faced lost sales. In addition, we are working diligently within the total prescribing ecosystem to ensure that all references such as the key compendia, retail pharmacy systems, and e-prescribing platforms used by HCPs accurately reflect the vesipa cardiovascular risk reduction indication and importantly understand that the generic products do not share this indication and are limited to lowering triglyceride in patients with triglycerides equal to or above 500 milligram per deciliter, which is effectively less than 10% of the patients in need of vesipa. Finally, with persistent CV risk patients, We are working to efficiently educate patients about the benefits of Vaseepa to drive patients to ask their doctor about Vaseepa, especially when they search out information on statins, triglyceride, CV risk reduction. We also inform them that Vaseepa is widely covered by Medicare and commercial providers and that our $9 for 90 days supply copay program for commercially insured patients is still available to them. We remain confident in the potential for growth of the SEPA in the US, even with the entry of generic competition. Thus far, generic penetration in the market is around 12% of the IPE market. Not your expected generic erosion, which at this point, if the SEPA were a typical product with generic entry, would have exceeded 90% months ago. We believe we have the opportunity and that is our obligation to continue to educate the market about the benefits of the CIPA and continue to drive demand. I will share more about how we will do this differently later in the call when I discuss my vision and future plans. Looking now to our very exciting opportunity in Europe, turn to slide six please. As in the US, the need for effective cardiovascular preventative care across Europe is significant. We see the European market opportunity at least as equal to or potentially larger than the US. It usually takes an agile biopharma company two to three years to establish itself in Europe and prepare for a product launch. The Ameren team established its presence in 15 European countries in what I consider a record time. And we now have employees covering 10 of the top 15 markets with the very large majority of our team based in Germany as we prepare for our first country launch. Outside of Germany, we have a limited core team in each large country or cluster of countries focusing on market access success and scientific engagement. Moving forward, we will not be adding additional commercial roles in any country until we see the green light for reimbursement on the horizon. This staged rollout allows us to control the timing of our investment as to when and where we can have immediate impact to drive revenue. We believe this model will best position us to achieve our goal to maximize the SCEPA reach in Europe and to become profitable on a country by country basis as soon as possible. Despite the limited time we had to prepare the market, We expect to have strong sequenced country launches and over time solid adoption as we continue to educate European audiences on the value of VASCIP. It's broad label and the fact that it's the only approved medication for cardiovascular risk reduction beyond LDL treatments in Europe. We previously communicated that our goal is to file 10 market access dossiers and I'm proud to report that we submitted these dossiers in four important markets. The markets are the United Kingdom, France, Italy and Denmark. The German dossier is ready for submission just prior to the launch date in September 2021. This was a big accomplishment in a short period of time. These submissions are extensive and include the data demonstrating the uniqueness of Vaskepa from a scientific perspective, various country-specific demographic data sets to define the eligible patient population based on the label and the targeted list pricing of approximately 200 euros or $240 monthly. This price is proposed based on a value-based strategy and we believe is justified based on the demonstrated clinical effectiveness of the SCIPA. The high economic burden and societal cost of heart attacks, strokes and other cardiovascular events that VASCEPA can help avoid. After the first 10 countries submissions for market access, we plan to pursue a second wave of reimbursement filings in other European countries. We also plan to implement an agency distributorship model in most Central and Eastern European markets. where it does not make business sense for us to have our own Ameren presence. Now that you have the big picture for Europe, let me share more details about our German launch. In preparation for this launch, we have hired a seasoned German team and have deployed a field force of approximately 150 sales reps to advance pre-launch disease and brand awareness initiatives. As a reminder, based on AMA rules, and Aaron could not promote the product nor mentioned the trade name until the EC approval date in April 2021. Additionally, and similar to the US, access to German physician is still limited as the fight against COVID-19 continues, despite increasing vaccination rates. Our team is making every effort to reach our target audience both physically and virtually as we prepare for the launch. We are ready to officially launch in September where we will debut our rollout with a dynamic launch event. The event will be led by nine leading key opinion leaders who will highlight the scientific underpinnings and clinical benefits of VASCEPA to reduce cardiovascular risk before an audience of approximately 200 German specialists in Berlin. This is the maximum attendance allowed by current German guidelines. for in-person events. In addition, the event will be offered as a live broadcast with the possibility to reach thousands of physicians in Germany and across Europe. The timing of our German launch falls immediately on the heels of the European Society of Cardiology annual meeting taking place the last week of August and into early September. This global meeting will provide a great backdrop for us to highlight the SCIPA's benefit through a series of scientific and clinical presentations. In addition, Ameren will have a considerable presence at this virtual meeting where our digital platforms for engagement will be showcased in our exhibit booth, product theater, and more. The combination of the ESC meeting and the launch event provide an ideal opportunity to amplify our messages before audiences of leading cardiologists in our target markets. with compelling clinical data in support of the use of Vaskepa to reduce cardiovascular risk. As we developed our European omni-channel engagement go-to-market model, we will be complementing all efforts by intensifying our digital channels to accelerate and enhance customer engagement and ultimately to drive awareness of the need to treat CV risk and the benefits of Vaskepa to reduce it. As we are launching in the last few months of 2021, 2022 will be the first launch year where we will have one year of German revenue and hopefully multiple additional countries joining the European Launch League. This is an exciting opportunity for Ameren to make a difference in the lives of the many millions of patients throughout Europe who are at risk of a cardiovascular event. I'm also excited to announce that Laurent Abouaf, will be succeeding me as Senior Vice President and President for Europe. Laurent is a seasoned leader with significant cardiometabolic experience from his time at AstraZeneca. He has experience in large, medium, and small-sized markets in both Europe and Asia, and I'm confident that he is the right leader to pick up the baton and lead Ameren for a big win in Europe. Finally, let me turn your attention to the rest of the world. In China, our partner Edding has made progress and still expects to receive approval of VASIPA in mainland China and Hong Kong near the end of 2021. With these approvals, Edding plans to launch in these territories in 2022. As in the US and Europe, VASIPA 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 a significant medical need and a meaningful market opportunity for Wasipa in China. Turning now to slide seven, let me share with you my vision for Ameren and a glimpse of our plans. As I officially assumed my new leadership role only five days ago, these are still early days That said, I am keen to share my excitement about the potential opportunities for growth and my confidence in Ameren's ability to deliver on these objectives. I envision Ameren growth will be delivered through three main directions on slide seven. Firstly, the breadth dimension or geographic expansion. We launched the cardiovascular risk reduction indication in the US in the first quarter of 2020. Our first country launch in Europe is planned toward the end of the third quarter 2021. So we have already embarked on this journey of global expansion, but now we want to take this to a different level. Our vision is to bring the cardioprotective benefits of Vascepa to patients worldwide, specifically to what most pharma companies consider to be the top 50 global cardiometabolic markets. Currently, We have access to approximately 30 of these between our North American, European and Chinese efforts. A new key priority moving forward is to ensure that we unlock the potential of the SEPA in the balance of these markets including Australia, New Zealand, select Latin American and additional Asian markets. We plan to initiate the regulatory filing processes in a number of these markets in the coming months. We have the clinical data to support these submissions and expect the regulatory review and approval times to range from 6 to 18 months from submission depending on the market. In many of these markets, we may not choose to be present ourselves and have already received requests for agency distributorship partnerships. 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. Collectively, this international expansion gives us access to another billion-dollar market opportunity for Ameren to leverage while making a difference in the lives of many millions of patients across the globe. Secondly, the height dimension or diversification. With our strong presence in the U.S. and the global expansion of ASEPA underway, Amarin has invested in building commercial infrastructure across the globe, which has created a great commercial asset for our company. We believe this asset makes Amarin an extremely attractive candidate for commercial partnerships. While our primary focus is squarely on growing branded Vesipa in the US, building Vaskepa in Europe and globally expanding the opportunity for Vesipa and other international markets, We plan not to waste any opportunity that will allow us to leverage the investment in our global commercial infrastructure. The first work stream we are prioritizing is our own life cycle planning for the SEPA. Eicosapent ethyl has proven to be a beneficial molecule in a number of clinical settings and we are actively evaluating other potential research settings in which to further explore and characterize the drug's activity. and these efforts will align with clinical and commercial needs across individual and global markets for the brand. The second work stream we are prioritizing is our business development effort. We have been active in the BD space, but we intend to intensify, accelerate and bolster our BD program. This is an opportunity to capitalize on the commercial and R&D infrastructure and expertise we already have in-house. Let me remind you that such efforts require time both because there are few true value creating opportunities and because we need to be very selective as to where we focus to ensure we continue to drive shareholder value. Thirdly, the depth dimension or go to market and operational evolution. The pharmaceutical market has been evolving for several years and now with COVID-19, we arrived at the tipping point. Access to physicians is becoming more and more limited via traditional channels and the significance and impact of payers is increasing. The role of the pharmacist is becoming more central with the complexity of care delivery and more importantly, patients need support to seek and adhere to therapies and solutions that will impact their health positively. So it is critical for us to rethink our go-to-market model and to continue to evolve it. We need to ensure that we are both effective and efficient in the way we run our operation, prioritize our choices among various key stakeholders and the different channels we use to engage with our customers. Earnestly revisiting what we are doing, why we are doing it, and how are we doing it is key to this effort. Our evolved orchestrated engagement model provides us with the breadth and depth of interaction we need to drive awareness, adoption and consistent usage in order to deliver growth. Finally, let me share some perspective on the timelines for executing on our three growth dimensions. Evolving the go-to-market model is immediate and the model we implemented in Europe is already aligned with this vision. When we look at our global expansion efforts, some of these are short term, such as our imminent launch in Germany. Many other European countries, along with our international expansion plans discussed today, will be more medium term. Finally, although our diversification effort is very active and ongoing, these initiatives tend to take more time and require substantial diligence to ensure they will add true shareholder value. With this overview of our vision and plans for the future, let me turn the call over to Mike called our CFO for a more detailed discussion of our financials. Mike?