Amarin Corporation plc

Welcome to Ameren Corporation's conference call to discuss its full year and fourth quarter 2021 financial results and operational updates. This conference call is being recorded today, March 1st, 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 factor section of our annual report on Form 10-K for the year ended December 31st, 2021, which has been filed with the SEC and is 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 SEPA. An archive of this call will be posted on Amron's website in the investor relations section. Karim Mikal, Amron's President and Chief Executive Officer, will lead our discussion and Mike Cobb, Amron's Chief Financial Officer, will provide a more detailed overview of our financial results. After prepared remarks, we will open the call to your questions. I remind you that multiple audiences typically listen to the 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 for review of the business. Karim?

Good morning and thank you all for joining us this morning. 2021 was an evolutionary year for Ameren, marked by our transformation to a truly global commercial company. Last August, we outlined our vision for our three-dimensional growth strategy, breadth or geographic expansion, height representing diversification, and depth or core operational evolution. Our achievements throughout 2021 have laid the groundwork for us to successfully execute the strategy and bring us closer to our goal of bringing the SEPA, the SCEPA, and its cardiovascular risk reduction benefits to at-risk patients around the world. First, with our European approval, we became a truly global company with an international footprint. We moved quickly to focus on this greater than a billion dollar long-term revenue opportunity with the goal of making the SCEPA cardiovascular benefits available for as many patients as possible in Europe. Second, we took actions to adapt to the evolving environment in the U.S. with the introduction of our new go-to-market strategy, which included restructuring the commercial organization and introducing a breadth of new digital capabilities. The result is an optimized organization where we are reaching and doing more with less, and we are already beginning to see some early results of these initiatives. Next, we introduced an international strategy and began executing on filings in order to gain approval and launch the SIPA through partners in approximately 20 additional key territories, which we believe represent an additional $1 billion long-term revenue opportunity. And lastly, but importantly, we introduced our intention to diversify, including the development of a fixed-dose combination portfolio. I'm pleased with the progress we've made, and now let me share some more details. Let me begin with a brief review of our results for the year. As you saw in our press release this morning, we reported net total revenue for the full year of 2021 of $583.2 million and $144.5 million for the last quarter of 2021. The bulk of this revenue continues to be from U.S. product sales of ASEPA. Importantly, we increased profitability in our U.S. Vesipa franchise, and along with our strong balance sheet, this will continue to support our European launch plans. Turning now to Ameren Progress in the U.S., where in October 2021, we introduced our go-to-market strategy, which I just mentioned. Included the restructure of the commercial organization and the introduction of a series of new digital capabilities. Our go-to-market strategy features a three-pronged approach that we believe will drive awareness, adoption, and demand of the U.S. business while providing flexibility to react to new headwinds as we face them. As I noted earlier, we are pleased to already be seeing preliminary results from these efforts. First, we are focused on expanding provider engagement. Our new digital omnichannel approach has allowed us to expand our reach and optimize our organization to do more with less. We have expanded reach to over 150,000 staff and prescribers through high-frequency, customized, and impactful messaging regarding the significant benefits of the SEPA for CV risk reduction. We are engaging with prescribers in the ways they want by utilizing virtual detailing, email campaigns, websites, and medical portals, digital webinars, social media, and more. While still early days, we are seeing some encouraging signs including close to 2,000 new prescribers activated nationwide. It's important to acknowledge that although there are some encouraging signs, we are not at pre-pandemic levels of engagement with healthcare practitioners. Further, given the significant market disruption, we're not sure that we'll ever go back to those levels of face-to-face engagement. Next, managed care access remains a focus. We have intensified our efforts to remove remaining barriers to the SEPA prescription so that we can improve access to patients with real medical need. We are working towards stabilizing our volume and demand, by focusing on enhancing payers' access. Currently, Ameren has approximately 40% of total commercial and Medicare Part E lives on a weighted average basis, with the SEPA as the exclusive IP product. Overall, we were able to improve access for the SEPA for 25% of all commercial lives. And moving forward, there are several important decisions we are awaiting that could significantly and positively impact our coverage this year. Finally, we are optimizing fulfillment of the CEPA prescription for CV risk reduction. We continue to face increased generic competition, where there are now three generics available on the market beginning in January of this year. We remain focused on driving the CEPA prescriptions for cardiovascular risk reduction and we are continuing our efforts to educate the market at every level and particularly at the pharmacy level. One example of our effort here is our recently launched the CIPA campaign focused on prior myocardial infarction and stroke patients at a heightened risk of a subsequent event to generate immediate growth acceleration. As communicated earlier, we partnered with BlinkRx in November 2021 to support the fulfillment of our prescriptions. We are already seeing an impact where we are experiencing accelerated physician uptake and patient prescription fills. The vast majority of patients that fill an IPE prescription in Blink elect to receive branded Vasepa due to its lower copay cost compared to generic alternatives. Most patients also elect to auto refill to aid continuity of treatment with branded receipts. Partnerships such as BlinkRx, where compensation to our partner is based on actual results, are a priority and a key focus of our marketing effort. We're also examining all of our resources and ensuring that our investments are profitable and aligned with our strategy. And as a result, around 50% of our U.S. marketing investment is now volume driven. While we expect market conditions will vary dynamically depending on a number of factors, our focus is on our ability to maintain a positive contribution margin. As you all know, the U.S. strategy remains critical to Ameren overall growth strategy as U.S. business profits are helping to support our European expansion, international growth, and investment in our pipeline. Before we move to Europe, I want to provide a brief update with regards to the district court decision on the Ameren versus HCMA and Health Net case. We are pleased that the court found that there exists sufficient basis and factual questions concerning inducement of infringement for the litigation to proceed against Health Net. Ameren will continue to vigorously pursue its case against Health Net. While we are disappointed in the ruling on HCMA's motion to dismiss, we recognize that this is an evolving area of the law. Ameren intends to appeal of the district's court decision. Ameren believes that its patents are being infringed upon and will continue to fight to protect the company's intellectual property. Turning now to our progress in Europe, which we believe is a greater than a billion dollar long-term revenue opportunity for Ameren. As I mentioned earlier, Following European regulatory approval, we made significant progress developing and executing a market access strategy with the goal of launching VASCEPA in Europe in a strategic, sequenced manner, aiming at optimizing both price and patient population. We started with an ambitious plan to submit reimbursement dossiers in 10 countries, and we achieved that goal ahead of schedule as we announced in our third quarter report. Moving forward, there will be a lot of information as we file in additional countries and enter reimbursement negotiation in key markets where we have already submitted dossiers. As a result, I think it's important to take this opportunity to review the process for commercializing a product in most markets in Europe. Although its market has its own differences, there are five major steps. Step one, is of course the regulatory approvals in the EU and UK. It's important to achieve a broad label language that represents the full patient population potential as this is the key for the next negotiating steps. We accomplished this in 2021 and with a patient population that is fully reflective of the REDUCE-IT study. Step two involves the development and filing of market access reimbursement dossiers which are submitted on a country-by-country basis. These dossiers include the summary of the scientific evidence, supporting the benefits of the product, and datasets defining the patient population that can benefit from Vaskepa in the specific country. Step three, this begins with a scientific evidence assessment or clinical review which involves reviewing study results, expert opinions in each market, assessing treatment benefits, and determining the eligible patient population for reimbursement. Once these reviews are complete, they render an opinion and move on to the next step. Step four is price negotiations. At this stage, you introduce pharmacoeconomic data and assessments. Other factors and variables are also considered, involve the overall budget impact and macroeconomic environment to arrive at a price for reimbursement. Finally, step five, you conclude the process with official price publication and launch. The one exception to this process I just described is Germany, where we launched in mid-September 2021. In order to provide patients with access to new medicine in Germany, new pharmaceuticals are given one year on the market with reimbursement as the market access process is underway. During this first declared pricing year, it's important to maximize the market opportunity, but also ensure that investments are flexible and adaptable to changing market conditions that can occur as part of the ongoing negotiation process. Every market also has its own nuances that play a role in the ultimate outcome. These include environmental factors and local market conditions that impact a company's ability to attain reimbursement, receive optimal pricing, maintain timelines, obtain target patient inclusion, and achieve adoption in a given market. That is why it's important to balance the level of investment with the right timing and probability of success. Investing too early is wasteful, while investing too late can adversely impact the outcome. our team has taken great care to thoughtfully build and assess each market prior to making decision on when and where to invest. It can take many months to work through the reimbursement and price negotiation processes. This is confounded by the fact that certain parts or opinions are made public at different times and through different formats depending on the market, making it difficult to know the specific outcome until the process is complete. This is part of the dynamic nature of European reimbursement and is anticipated. It's important during this process to reiterate that our filing and reimbursement process thus far is going largely according to plan. We have assembled a strong, talented team that is working through these various stages in parallel in several markets, and we feel confident of the favorable outcome. As you know, We completed market access dossier submissions in 10 countries, Germany, UK, Italy, France, Spain, Denmark, Sweden, Finland, Norway, and the Netherlands, and are now in the active pricing negotiation phase in a number of these markets. This process will take several months to complete. I am pleased overall with the way these negotiations are proceeding in line with our plan to launch in up to six countries in 2022, and I remain confident in our $1 billion plus opportunity in Europe. In Central and Eastern European countries, we are actively negotiating partnerships to bring Vaskepa to various countries via marketing and distribution agreements with partners who have established infrastructure in such markets. We look forward to reaching agreements later this year and to launch subsequently in these markets. Moving on to our progress advancing into other international markets, which we consider everything outside of Europe and the U.S. In the fourth quarter of 2021, we introduced our strategy to bring the cardioprotective benefits of the CEPA to 20 additional markets over the next three years. In 2022, our goal is to submit regulatory filings and obtain product approval in up to six countries. I am pleased to announce that we have filed and received confirmations that our filings have been accepted for regulatory reviews in Australia and Israel. After careful evaluation, we have made the decision to seek partners in all of these international markets, and that process is underway now. We believe this opportunity represents the potential of an additional $1 billion in revenue. Now, an update on the already partnered international territories, China, Middle East, North Africa, and Canada. In China, our partner Edding Farm continues to expect to receive approval of a SEPA in mainland China and Hong Kong by the end of 2022. China is a significant market opportunity and we continue to work hard with our partners to be ready to launch. In the Middle East, North Africa, we received regulatory approval and reimbursement are in the process of launching in several markets. We have previously shared the co-promotion agreement between HLS, our partner in Canada, with Pfizer that was initiated in the fall of 2021. This collaboration represents a further validation of the SEPA and the importance of the reduced data to cardiovascular medicines worldwide. We look forward to sharing more details on this partnership in 2022. Looking ahead to the international expansion, in 2023, we plan to seek approval in up to nine additional countries, and in 2024, we expect to complete regulatory approval filings in the remaining five countries we targeted. These filings will all be supported by the long-term cardiovascular outcome data from the landmark reduced study, along with the FDA and EMEA approvals of the SIPA-VASCEPA for the cardiovascular risk reduction indication. Finally, let me share some perspective on our thoughts around diversification, the high dimension of our global strategy, in addition to our geographic expansion, where you can see we are making great progress. We also announced our plans for lifecycle management of our vesipa-veskepa acid with the development of a fixed-dose combination portfolio. The medical rationale is key to drive the development of a fixed-dose combination in cardiovascular disease. Combining multiple prophylactic agents for cardiovascular disease into one pill was proposed by the WHO since 2002 to increase adherence and adequate dosing. In the lipid-specific context, the European Society of Cardiology Working Group on cardiovascular pharmacotherapy has recommended the use of fixed-dose lipid-lowering combination drugs to increase adherence. In patients at very high risk, such as those with a history of a cardiovascular event, the group recommends initiation of fixed-dose combination treatment immediately after the event. The rationale for this recommendation is that immediate combination therapy may avoid potential barriers related to the multiple visits needed for treatment intensification. For the patients, fixed-dose combination therapy can improve adherence as evidenced by studies performed in both Europe and the U.S. with improvements in adherence and lower number of healthcare provider visits a fixed-dose combination therapy has the potential to improve clinical outcomes, including evidence of improvement in biomarker levels in patients. This will also translate in enhanced therapy with reduced bill burden and significant convenience factor as many high-risk cardiovascular patients have other comorbidities and therefore multiple medications. Commercially, This allows us to maximize the investment made into the reduced study, where IPE was used on top of a statin by offering the benefits of vasepa-vaskepa in a broad portfolio of products. We look forward to sharing more on the development of our fixed-dose combination portfolio as we move further into the development process, potentially later this year. We also remain committed to evaluating opportunities outside of Ameren to leverage our capabilities and diversify our portfolio while ensuring we remain financially strong. This remains a core area of focus for our team. Finally, and before we turn to financial results, underlying our growth strategy and our objectives for this year is our commitment to operational excellence. We are continuing to update and strengthen our leadership team and the board. We are focused on making profitable investments in growth with a focus on flexible investments to ensure our ability to adapt to a dynamic environment and achieve our multi-billion dollar global expansion strategy. And we are committed to a strong balance sheet in order to continue to invest in our expansion strategy for the foreseeable future. With this overview of our business, Let me turn the call to Mike Calder, CFO, for a more detailed discussion of our finances. Mike?