Amarin Corporation plc

Welcome to Ameren Corporation's conference call to discuss its second quarter 2022 financial results and operational updates. This conference call is being recorded today, August 3, 2022. I would like to turn the conference call over to Lisa DeFrancesco, 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 risk 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 31st, 2021 in our Form 10-Q for the quarter ended June 30, 2022, 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 the SEPA. An archive of this call will be posted on Amron's website in the Investor Relations section. Corrine McHale, Amron'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 recent clinical data and publications, and Tom Riley, Airman's new Chief Financial Officer, will provide a more detailed review of our second 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 positioning. I will 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. As we enter the second half of this pivotal year for Ameren, we continue to focus on our three-dimensional growth strategy, breadth or geographic expansion, height representing diversification, and depth or core operational evolution. Recently, I surpassed my one-year anniversary as president and CEO of Ameren and have had the chance to reflect on the significant transformation of the company over the past year. In the U.S., we faced continued pressure from additional generic competition. We focused on maintaining profitability, and through our commercial efforts, we were able to retain a level of market share even to this day, that is unprecedented in any generic market. And more importantly, continued to deliver significant positive contribution margin, allowing Ameren to self-fund the expansion to Europe and internationally. During this past year, we made the difficult decision to implement two major restructures. The first was fully focused on the U.S. commercial structure, and the second impacted our company more broadly, in order to manage our costs throughout the period and to address the evolving and challenging U.S. market dynamics. We did this while undertaking a bold strategy for global expansion, which was highlighted by more than 10 market access filings in Europe and multiple regulatory filings in other geographies. With recent achievements, including three country reimbursement wins in Europe and a number of international product approvals for the SIPA, we are beginning to see the bold strategy take shape. In addition, we completely reshaped our leadership team with over 70% of our executive team joining Ameren in the past year, many in the last six months. These accomplishments provide us an even greater confidence that our long-term objectives for Ameren are ambitious but also achievable. Now to touch on the second quarter, beginning with comments on Europe, where we have made considerable progress executing our strategy, and because it is the source of future growth, expansion, and value creation for Ameren shareholders. 2022 has been about laying the foundation for our future across Europe. Midway through the year, we have made considerable progress in key markets, with more to come in the second half of 2022. It's important to note that we have taken a regional approach to growth and expansion in Europe, where our success does not rely on any single market, but rather on building strong, sustainable, diverse revenue streams in individual markets across the continent. And we were delighted to have achieved final positive reimbursement from NICE with reimbursement secured for patients in England and Wales at a strong net price of approximately $176. This was a big milestone as it marks our first positive final reimbursement decision from a large EU5 market. Note that net prices in Europe, especially for chronic treatments, tend to be much lower than U.S. prices. This achievement, and specifically this level of reimbursed net price, acknowledges the value of VASCEPA and our ability to demonstrate this value to payers in Europe. In the UK, we are in the process of establishing formulary access and launch preparations are underway with a formal launch plan for October. We were encouraged by the excitement and enthusiasm in the market regarding the final reimbursement decision by the local authorities, including NHS, as they look to combat cardiovascular health as a key national health priority. We're focused on educating the market on the benefits of ASCIPA and establishing ASCIPA as a new standard of care to reduce the risk of CV events beyond LDL management. Our objective is to drive this education through medical and scientific engagement, implementing formulary guidelines, and building awareness and adoption through multiple commercial channels. This follows the first national reimbursement decision for Vaskepa in Sweden, where the work to obtain formulary status and launch is well underway. We also achieved individual patient reimbursement in Denmark, are in the process of filing for national reimbursement as a next step in that country. With these achievements, we have truly transitioned to the next phase of our global expansion strategy. And I'm pleased to share that we have also made progress in a second major EU5 market, Spain, where we have begun pricing discussions with Spain Ministry of Health earlier than anticipated. This gives us strong confidence for a possible pricing and reimbursement decision in Spain before year-end. I also want to provide an update on Germany, where we are on the market with temporary reimbursement. Germany continues to be impacted by unprecedented local market conditions. including healthcare austerity measures, which are being implemented as a result of the challenging political and economic situation in Europe, which has impacted our sales during this launch period. At this time, we remain in constant dialogue with the German health authorities and expect the process to complete in November, and we may use our full timeline for these negotiations. Based on the status of the negotiations and current market conditions, we have suspended our contracted primary care field force to avoid having these resources becoming permanent, which was contractually scheduled to occur. We are committed to our presence in Germany pending the outcome of current negotiations with the payer, which remain actively underway. This decision reflects our disciplined financial management and is in keeping with how we have been actively managing our investments to remain prudent and flexible. Across Europe, we continue to advance our reimbursement discussions with national health authorities in Norway, Finland, France, Italy, Israel and the Netherlands. We have also added to the list Portugal, Austria and Switzerland, where we have recently submitted and are now on file for reimbursement discussions. This brings the total number of submitted dossiers to 14 countries in Europe. In addition, partnership discussions in Central and Eastern Europe are advancing well. With our reimbursement and pricing success thus far, we remain on track to receive reimbursement decisions in up to eight countries and to launch VASCEPA in up to six European countries this year. Our achievements in Europe in just under one year give us further confidence that the opportunity in Europe remains a $1 billion plus opportunity. We believe 2023 will be an exciting year where we expect a pivot the revenue generation stage of our bold global expansion strategy now moving to our results in the quarter and the us business in the second quarter of 2022 we recorded 94.4 million dollars in total net revenue including 90.6 million dollars in u.s product sales reflecting the anticipated continued pressure from generic competition in the market The results reflect the full impact of the third generic entrant compared with one generic in the market the previous year's quarter. The pressure was offset by a normalization of some of the trade patterns and inventory destocking we saw in the first quarter, which Tom will discuss in greater detail with you shortly. Overall, While the US market remains challenging, I'm pleased that the revenue this quarter was consistent relative to the first quarter, which speaks to the efforts of the team to retain and support the business. As part of our company-wide focus on operational excellence, we remain committed to maintaining a strong contribution margin for our US business. To that end, we took the difficult but necessary step to announce a comprehensive cost reduction plan to address expenses and market dynamics within the U.S. business, which will result in $100 million in savings through the middle of next year. Tom will talk more about this plan shortly. The goal of our cost-containment initiative is to continue to offset the challenges we are experiencing in the market with a focus on operational excellence that allows us to maintain the U.S. business positive contribution margin. While the cost containment initiative in June was comprehensive and involved cost reduction across the entire organization, the largest portion of the savings was related to a reduction in the U.S. commercial organization, creating a core focus team. The strategy allows for a core sales force to support branded receipt of sales by fully targeting around 14,000 of our most loyal prescribers as we continue to focus on secondary prevention in key CV risk indication, such as prior MI and stroke. Moving forward, our efforts are focused on sustaining and supporting the Vesepa brand and prescriber base we have today in the U.S. Supporting these efforts is the compelling data from REDUCE-IT that shows that CEPA reduced CV events by 35% in prior MI patients. The benefits of CEPA 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 an elevated risk for recurrent CV problems. These results further strengthen the case we are making to the physicians who care for these high-risk patients for pure EPA in the form of prescription icosapent ethyl as a key intervention beyond statins for meaningful risk reduction. Our efforts to secure exclusive business is working so far. The exclusive business has not experienced any major changes since the end of last quarter as a result of these efforts. The exclusive business is continuing to grow as a percentage of the total Ameren business. That said, we expect volumes will continue to experience some pressure throughout this year. And as we look ahead to the third quarter in particular, we anticipate continued pressure from generics as well as lower revenue due to the seasonality typically seen within the third quarter for this market. We will continue to closely monitor the market dynamics in the U.S. and adjust as necessary, wherever possible. Beyond Europe and the US, we continue to make progress on our bold plan to unlock the potential of the SEPA internationally. First, let me cover our partner three geographies. Our Canadian partner, HLS Therapeutics, continues to make good progress working with all participating provincial jurisdiction to secure coverage from publicly funded drug plans across Canada. They have secured public market access reimbursement for VASIPA in Ontario, Quebec, New Brunswick, Saskatchewan, and with other public payers. We look forward to their continued progress in the coming months. Public market reimbursement for VASIPA in a large single-payer country like Canada is a validation of the CV risk reduction benefits of the product that underscores its pharmacoeconomic value. As a reminder, last year we agreed to HLS partnership with Pfizer, by which HLS will promote to specialists and Pfizer will promote to the large primary care physician groups. We have been closely watching the progress of this strategy, as it may be a model that can be replicated elsewhere internationally. Biologics, our partner in the Middle East and North Africa MENA region, continues to pursue the review and approval for the cardiovascular risk reduction indication in the Kingdom of Saudi Arabia and Kuwait. As a reminder, VSIPA is currently approved in a total of six countries in the MENA region, including KSA and Kuwait for the VHDG indication, and in the United Arab Emirates, Lebanon, Bahrain, and Qatar for both the VHDG and cardiovascular risk indication. Lastly, our partner in China, Edding, received approval for Vaseepa in Hong Kong for the CV reduction indication, and a commercial launch is being 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 reduced According to Edding, they anticipate that a decision can still be expected by the end of this year. Now let me cover our expansion efforts beyond these three mentioned geographies. The plan calls for three waves of regulatory submissions for approval of VSEPA in 20 additional countries in order to ensure that patients in the top 50 cardiometabolic markets worldwide can benefit from VSEPA. Toward that end, we continue to make meaningful progress in the first wave of these efforts. Dossiers remain in full assessment by the respective national regulatory authorities in Australia and New Zealand. In Israel and Switzerland, dossiers are under regulatory review, and along with Austria are in reimbursement discussions. These markets will be managed and discussed within our Europe business. Moving forward, we remain confident in the multi-billion global market opportunity for VASCEPA in Europe and internationally and are pleased with our recent achievements. We are beginning to turn this opportunity into a reality with future launches anticipated later this year and next. In addition, we took steps to ensure our continued investments in our clinical data and pipeline, including maintaining a strong presence at important medical meetings and implementing a stepwise approach to the development of our fixed-dose combination, which ensures our ongoing progress with this important program that combines the CEPA with the statin. To talk more about these efforts, I will now turn the call over to Dr. Steve Ketcham, Amron EVP, President of R&D and Chief Scientific Officer, to discuss recent advancements with our data, plans for presentation at this year's European Society of Cardiology Annual Meeting, later this month and progress with our fixed dose combination. Steve?