Amarin Corporation plc

Welcome to Ameren Corporation's conference call to discuss its third quarter 2022 financial results and operational updates. This conference call is being recorded October 27, 2022. I would now 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 31, 2021, and our Form 10-Q for the quarter ended September 30, 2022. which have been filed with the FCC and are available throughout 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. Karim Mikhael, Amron's President and Chief Executive Officer, will lead our discussion, and Tom Riley, Amron's Chief Financial Officer, will provide a more detailed review of our third 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 Mikhail, President and Chief Executive Officer of Ameren. Karim?

Thank you, Lisa. Good morning and thank you all for joining us today. We began this year embarking on a bold strategy to grow and expand globally. We focused our three-dimensional growth strategy, breadth or geographic expansion, height representing diversification, and depth or core operational evolution. Now with 2022 nearing a close and despite the significant headwinds and challenges faced early in the year, We are pleased to report that we made significant progress across our key priorities, and we continue to achieve what we committed to. Most importantly, we have turned around our cash burn levels as we strengthened our foundation through operational excellence, strengthened our leadership team, and laid the groundwork for a true transformation of Ameren in 2023. I'm going to begin today by discussing the results of our cash preservation initiatives because I believe this progress is significant and critical to support our future growth and expansion plans. There are two key initiatives that were central to our effort and the progress delivered. First, in June, we took swift action announcing an extensive cost savings plan to reduce our operating expenses by $100 million over 12 months. This initiative was comprehensive and involved cost reductions across the entire organization, and we are beginning to realize these savings this quarter exactly as planned. Second, beginning last quarter and as part of our company-wide focus on operational excellence, we took steps to evolve our supply chain strategy and amend our supplier agreements to align supply arrangements with current and future demand within our U.S. business. These initiatives, which Tom will discuss in more detail shortly, have resulted in significantly lower cash burn quarter over quarter. In fact, this quarter, we are cash positive, excluding restructuring charges. Also contributing to the improvement of our cash runway is the consistent stabilization of the U.S. revenue over the last three quarters, despite continued pressure from additional generic competition. We achieved this by refocusing our core U.S. team efforts to sustain and support the Vesipa brand. Additionally, and as a result of the difficult decisions made at the right time to reduce commercial footprint in the U.S., we remain highly profitable, supporting future international growth. As I look at our third quarter results and in the U.S. business, I'm pleased to say our strategy is working. In the third quarter of 2022, we recorded $89.9 million in total net revenue, including $87.9 million in U.S. product sales, largely unchanged from last quarter despite the continued pressure from generic competition and the restructuring effort we announced in June, which reduced our sales and marketing efforts and commercial footprint in the U.S. significantly. This is now the third consecutive quarter with relatively consistent revenue performance despite continued generic competition, which is unprecedented in the industry. And the third quarter performance was achieved with a more efficient footprint and resources, which speaks to the strength and efforts of this poor U.S. team. Our steps to focus on promoting our brand are working. Based on the latest prescription trends, we are maintaining current share at roughly 60% of the total IPE market on a quarterly basis. We will continue to closely monitor the market dynamics in the U.S. and remain ready to adjust as necessary, whatever possible. With the stabilization of the U.S. business and the bold cash preservation actions we have taken, we have successfully extended our cash runway to ensure we can fund our expansion plan. While I began today's discussion with the recent actions dedicated to strengthening our financial foundation and preserving our U.S. revenues, we remain laser-focused on our core future objective, which is global growth and expansion for VASIPA, VASCEPA in Europe and internationally, as this is the key to shareholder value creation. 2022 has been about laying the foundation for our future across Europe, and we are now beginning to see this take shape before our eyes. We are now officially on the market and in commercial launch stage in the UK and Sweden. We recently received final positive national reimbursement in Finland and Northern Ireland at a price in line with our recent UK pricing. We also received individual reimbursement in Austria with a process underway for national reimbursement. Although there are no set timelines in any of the remaining major markets, we are now negotiating reimbursement and are now in the advanced stages in all markets. In particular, price negotiations are nearing conclusion with Spain's Ministry of Health, which could allow for a possible pricing and reimbursement decision shortly before the end of 2022. In the Netherlands, we received a positive scientific assessment by the National Healthcare Institute, ZIN, for reimbursement and are beginning pricing negotiation with the Dutch Ministry of Health. This is why we have filed in 13 markets simultaneously since 2021 and are now in the mid to late stage reimbursement negotiations in France, Italy, Spain, the Netherlands, and Norway. This progress thus far, and specifically the level of reimbursed net price we have received, acknowledges the value of Basquepa and our ability to demonstrate this value to payers across Europe. Turning to commercialization efforts in Europe, In the UK, our launch is underway since mid-October and is progressing well and in line with our expectation based on our deep understanding of the market. To provide some context on the UK market and how it operates, there are three distinct tiers of healthcare administration in England. NHS England, or the National Health Services, which provides guidance on usage. Next, the integrated care systems are consolidations of organizations that plan for service delivery and funding. The final tier are local accounts with formularies, which list the reimbursed products. As you recall, since receiving our final approval in July, we have been following the typical process while we await approval for public funding. We spent the first 90 days post-approval focused on gaining formulary access through education, medical and scientific engagement, implementing formulary guidelines, and building awareness and adoption through multiple educational and commercial channels. And we are simultaneously building a strong team in the UK. As I mentioned earlier this month, public funding is now becoming available, and we are transitioning to the commercial focus. The number of formulary inclusion of Vaskepa continues to track ahead of analogs and is improving weekly thanks to the clear, stepwise approach to achieve both formulary listing and medicines pathway inclusion. We are proud that Vaskepa is making its way as a new standard of care to reduce the risk of CV events beyond LDLC management in England. We will be updating investors with our UK performance to ensure everyone can keep track of our progress versus benchmarks over the next quarters. Turning to the rest of Europe, we're also progressing in other major markets as well as continuing to advance our reimbursement discussions with national health authorities in Norway, Italy, France, the Netherlands, Portugal and Switzerland where we have recently submitted and are now on file for reimbursement discussions. We remain on track to receive reimbursement decisions in up to eight countries and to launch Vaskepa in up to six European countries this year. And we remain confident that 2023 will be the beginning of strong, sustainable revenue generation toward $1 billion plus peak opportunity in Europe. Our progress continues beyond Europe, where we continue our plan to file in up to 20 countries through 2024. I'm pleased to say thus far we have filed in 10 markets with the potential for a number of others before year-end and into early 2023. Specifically, Ameren's marketing authorization submissions for VASIPA-VASCEPA have been achieved in Hong Kong, Saudi Arabia, and Bahrain, and applications remain pending in a number of other markets, including Australia and New Zealand, which are continuing to advance their local procedures. We've also confirmed that our regulatory filings are now actively under review in South Africa and other markets. This is critical as we continue our search for the right partner in all those international territories where we do not plan to build our own infrastructure. Our current partners continue to make progress as well, including Edding Farm, our partner in China, recently stated that they have received confirmation that the Chinese government has completed the product testing and has initiated the final review period prior to approval. This final review began earlier this month and has a clock of up to 67 business days. Our partner has communicated to us that they anticipate an approval could still be achieved before year end. In Canada, HLS Therapeutics Inc. has obtained reimbursement from all major public payers, gaining access to the vast majority of eligible patients in Canada. They continue to be in the launch phase in the public sector. We remain confident in the multi-billion dollar global market opportunity for VASIPA-VASCEPA in Europe and internationally. And we continue to invest in our data and evidence building of IPE now with a global focus. Following a leading presence at the European Society of Cardiology Congress over the summer, we remain committed to maintaining a strong presence at important medical meetings including the upcoming Canadian Cardiovascular Congress, American Heart Association, and the International Society for Pharmaceutical Outcome Research in Europe, which is a premier congress to discuss healthcare outcomes research. Our data was selected for presentation demonstrating the cost-effectiveness of the SEPA in treating cardiovascular outcomes in the Netherlands. Lastly, we continue to develop our fixed-dose combination, which ensures our ongoing progress with this important program that combines the SEPA with the standards. To summarize our progress year-to-date, we are experiencing stable business trends in the U.S., taking important steps to preserve our cash. Our global expansion plans remain on track, and we are continuing to focus on building data evidence and furthering our pipeline for the future. With that, I'll turn it over to Tom to talk more about our progress and strong results this quarter. Tom?