Amarin Corporation plc (AMRN) Earnings Call Transcript & Summary

Welcome to Amarin Corporation's conference call. I would like to turn the conference call over to Mark Marmur, Vice President, Corporate Communications and Investor Relations at Amarin.

Good morning and good afternoon, 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 under federal securities law. 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 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, 2024, and the quarterly report on Form 10-Q for the quarter ended March 31, 2025, which have been filed with the SEC and are available through the Investor Relations section of our website at www.amarincorp.com. We encourage everyone to read these documents. Our participants today who will share prepared comments are Aaron Berg, Amarin's President and Chief Executive Officer; and Pete Fishman, Amarin's Chief Financial Officer. Afterward, we will have a question-and-answer session. Now let me turn it over to Aaron.

Thank you, Mark. Good day, everyone. Thank you for taking the time for us to speak with you regarding today's exciting announcements about our refined strategy for Amarin and in particular, our exciting new partnership for VAZKEPA in Europe. This is a significant step that impacts the millions of patients in Europe that risk for cardiovascular event as well as all Amarin shareholders. As announced earlier today, we have reached an agreement with Recordati, a successful, well-established company with extensive cardiovascular expertise, which sets in motion a new path to reach more cardiovascular disease patients throughout Europe with VAZKEPA. With this long-term partnership with Recordati, VAZKEPA will be in the hands of a partner with the experience, established infrastructure and resources to build on the progress our team has achieved to date. VASCEPA has proven clinical success backed by the landmark REDUCE-IT trial and U.S. launch experience, ever-growing support from KOLs and leading medical societies due to the proven efficacy and safety profile and the increasing recognition that VASCEPA represents a unique product, one that is complementary to current therapies available today for physicians addressing the global burden of cardiovascular risk in their patients. The Recordati team shares our passion for the scientific data supporting the benefits of VAZKEPA and intend to make the product a priority for their organization. As a testament to this, Recordati will be promoting this product through their specialty and primary care sales force across Europe. The economics of the agreement consists of several core components. First, Amarin will receive an upfront payment of $25 million, which will immediately increase our cash balance. Second, the company is eligible to receive milestone payments, totaling up to $150 million contingent upon Recordati achieving predefined annual commercial net sales levels. And third, Amarin will receive supply-based revenues, including royalties that are material to Amarin for the supply of the product under the terms of the agreement. This component is the most significant portion of the value of this long-term partnership, as Recordati commercializes the product across Europe. Turning to another important element of today's announcement regarding our refined strategy. As a result of this partnership, we intend to further restructure our operations to be a leaner organization in support of our global business, focused on helping as many at-risk cardiovascular disease patients around the world with VASCEPA as possible and generating value for shareholders by focusing on the following. In Europe, as mentioned, a region with enormous unmet need in cardiovascular disease and growth potential for VAZKEPA, our team has made important progress with patient access and revenues increasing. VAZKEPA is in the early stages of commercialization in a number of European countries, and we look forward to doing all we can to support our new very capable partner to drive long-term growth with VAZKEPA, where we have patent protection until 2039. In the U.S., there have been almost 28 million prescriptions for VASCEPA written with almost 2.4 million patients treated since launch. We continue to efficiently and profitably drive VASCEPA revenue in the U.S. And in a number of markets in the rest of the world, where VASCEPA is in the earliest stages of commercialization, we will continue to work with our numerous regional partners to drive access and utilization by the millions of at-risk CVD patients in those markets. Taken together, CVD remains the #1 killer globally. The clinical data proves VASCEPA reduces cardiovascular events even if LDL is controlled and with global patient access already high and continually increasing, there is a significant opportunity to drive future growth by helping patients, while generating value for all shareholders. Now I'll turn the call over to Pete to talk further about today's announcement and our financial profile moving forward.

Thank you, Aaron. Before I go into the details of the Recordati agreement, I would like to touch on the work that has been done over the last 2.5 years to improve our capital structure. We decreased our cost base by approximately $170 million, driven by our focus on aligning our expenses as our business evolves. We renegotiated our supply agreements to rightsize our supply commitments, decreasing our supply expenditures, resulting in a drawdown of our inventory by approximately 45%. These supply agreements also allow us to meet future demand in a cost-effective manner. Finally, we have driven significant cost-efficient revenue in the U.S. and rest of world. These actions allowed us to prudently invest in building our European infrastructure, leading to the progress made in opening access to VASCEPA in the region, while at the same time, keeping our cash burn below 10%. The partnership with Recordati allows us to accelerate the work we have been doing and maximize our resources for the future. Based on the terms of the Recordati agreement, as Aaron mentioned, there are 3 key financial components: the upfront cash payment, predefined sales-based milestone payments and supply-based revenues, including royalties for product supply. In addition to these financial components, our announcement today will improve our cost structure moving forward. As we transition all commercial activities for VAZKEPA to Recordati, we will align our global organization with our new operating model, which we expect will result in cost savings of approximately $70 million over the next 12 months. The vast majority of these savings will come from our European commercial business. At the same time, we remain focused on supporting our partners in the rest of the world as well as driving the U.S. business. We have numerous partnerships in key international markets throughout the rest of the world. We will continue to support these partners in advancing access and penetration to generate revenue and meaningful cash contributions with minimal capital required. Though in the early stages in many of these markets, this is a proven and repeatable model that shows the value potential of VAZKEPA in Europe with Recordati and validates our ongoing efforts to position VASCEPA globally. In the U.S., we will continue focusing on efficiently driving VASCEPA revenue. Our U.S. business is a mature, profitable enterprise with meaningful cash generation. We continue to be the IPE market leader, showing the continued strength of the brand. Once the Recordati partnership and reorganization efforts are fully realized, Amarin will move forward with an even stronger financial foundation. We'll have approximately $300 million in cash, no debt, a significantly more efficient operating footprint and multiple revenue streams, resulting in an accelerated path to positive long-term cash flow. We are driven to realize the value of this unique product and supporting our partners' efforts to tackle the leading cause of death worldwide. Let me now turn the call back over to Aaron for closing remarks. Aaron?

Thanks, Pete. Let me close by returning to where I began by summarizing how the European partnership and refined strategy overall further strengthen Amarin for the future. We are fulfilling our commitment to identify and take actions that maximize the patient impact of VASCEPA and as a result, generate value for shareholders. The Recordati partnership to further capitalize on the market in Europe is a timely and meaningful step forward in the execution of our global strategy and paves a clear path for continued strengthening of the company's financial position. This partnership with Recordati is accretive. It monetizes the European market opportunity by contributing meaningful cash to our balance sheet to an initial upfront payment, the potential for future milestone payments and supply-based revenues, including royalties material to Amarin for the supply of the product under the terms of the agreement. We are partnering with a world-class organization in Recordati, uniquely positioned to maximize the commercial opportunity for VAZKEPA in Europe. We're confident in Recordati's ability to lead the next phase of growth and impact patient care with VAZKEPA throughout Europe and look forward to working with them. We're sharpening our operational focus by restructuring the organization, which positions the company for greater future financial performance. Taken together, the actions we've announced today accelerate Amarin's path to positive cash flow and further strengthens our position for the future. And finally, we continue to act in a proactive and decisive manner to identify and pursue additional strategic opportunities to drive shareholder value. Nothing is off the table, and we're working with the assistance of Barclays as our financial adviser. Before I close this part of the call, I want to extend my sincere appreciation to the entire Amarin team. I've had the privilege of working with an incredibly talented, determined, just a wonderful group of people. I thank each of you for the challenging yet very important work you've done for the company and for the patients and shareholders we serve. That concludes my prepared comments. Let's begin the Q&A session. Operator?

[Operator Instructions] Your first question for today is from Jessica Fye with JPMorgan.

This is Abdul on for Jess. How should we think about the sales thresholds associated with commercial milestones? And can you provide any color on the royalty rate structure, specifically how it's determined? And are there any tiered performance-based adjustments to that?

Yes. Thank you very much for the questions, and thanks for taking the time to join us this morning on such short notice. So regarding the sales milestones, as we've said in the recorded comments that we can earn $150 million on the net sales based on the performance of Recordati, as it goes forward. The terms specifically in the milestone thresholds are confidential, but we're confident that Recordati will be able to drive performance, and that will be meaningful to Amarin. Regarding the royalty structure, I'll have Pete -- again, the terms are confidential, but I'll let Pete provide added color regarding the royalty structure.

Thanks, Aaron. Yes, regarding the royalty structure, and I'll look at the supply and royalty structure combined. And what I would say is you can use as an initial analogy. Our other partnership agreements would have a similar operating income perspective from that covering our costs plus a percentage of royalties based off of the net sales, and this allows Amarin to ability to share in the growth of the product in the region over time.

Your next question for today is from Mazahir Alimohamed with Leerink.

On for Roanna Ruiz. So 2 from us. I guess the first one would be, can you elaborate a little bit on how Amarin determined this was the right time to out-license Europe versus continuing direct commercialization? And then the second one is just given the unique cardiology profile, like how will Amarin collaborate with Recordati to ensure optimal positioning of VAZKEPA within the modern CV risk reduction landscape so -- especially with like newer agents like PCSK9 and GLP-1s and inclisiran as they gain traction?

Thanks for the questions. So first of all, regarding the timing, we know that Europe presents a significant opportunity because of the enormous unmet need in cardiovascular disease. And we know from our experience, in particular from the U.S. and from the clinical profile of VAZKEPA that there is significant opportunity with VAZKEPA for growth because of the unmet need. So we know the potential is there. Our team has the last several years in Europe worked very, very hard and very challenging dynamics, as you know, in Europe. Even the biggest companies are challenged launching products in European countries. It's in particular difficult for a one-product company with no established infrastructure to start and build from scratch. And it's a long-term endeavor. This product has significant potential, but that also means it takes significant resources over a period of time. Based on the progress we've made and commercialized now in 10 countries, pricing and reimbursement progress has been good. Early commercialization progress has been very good. We've had a very good -- very talented team making very good progress, but we also know that longer term, the product requires more. And Recordati is ideally positioned for this, and that gets into your second question. They intend to make this product a priority. They have tremendous expertise and established infrastructure. They certainly know cardiovascular. They've had decades of experience and specifically in lipids as well. And to your point around the market in lipids, it is an increasingly crowded market in -- with lipid products, but primarily, they're LDL-lowering products and -- which is critical. It's the primary targeted therapy. And as you know from the REDUCE-IT data, VASCEPA was studied in patients that had controlled LDL and provided significant risk reduction in those patients. So we support that LDL lowering is the primary target of therapy, but more needs to be done and more can be done today because VAZKEPA proves you could reduce -- further reduce cardiovascular events in those patients. So it's complementary to these other agents as you treat it. So we don't compete directly head on with some of these drugs that are now becoming increasingly foundational like PCSK9 inhibitors. We don't compete with statins or ezetimibe or any other LDL-lowering drug. It's complementary, and that's the benefit that we have, significant clinical data, significant third-party support, significant scientific community support. So the timing was really right because the foundation is laid, and we found the right partner at the right time. And, yes, maybe one other added point, as I said in the comments, too, is Recordati plans to promote this product with the specialty and with their primary care organization. So you can see that they recognize, they share our passion of the data and the potential. And again, we look forward to helping them succeed.

Your next question for today is from Paul Choi with Goldman Sachs.

This is Daniel on for Paul. We're curious about what's your U.S. strategy going from here. And we have a second question on -- if you can share any colors on the skinny label patent lawsuit? Is there like the next timing update that you're expecting that you could share?

Can you repeat the first question? It was very difficult to hear. Our apologies.

What's your U.S. strategy going ahead?

Yes. Thank you. I appreciate the questions. So for the U.S., years ago, we altered our strategy and turned out to be very successful in that we focused on payer access. As the market became increasingly genericized, the first generics introduced at the end of 2020. And we -- what we did was we altered our commercial strategy by reducing investment in sales and marketing so that we could focus more on the payer side. And that's why we continue to have a successful branded business years after generic introduction, which is highly unusual, as you likely know. We've generated $2 billion in net sales since the generics were introduced, which is quite an accomplishment. That strategy continues to work. It's a profitable business. We have a remarkably lean organization from a commercial perspective in the U.S., and we'll continue with that strategy because we continue to have a brand as we go forward. As the market continues to evolve, we know that there are pressures -- increasing pressures as it's a generic market, and we're prepared when and if the time comes to launch an authorized generic and continue to generate revenues for years to come. In terms of the skinny label, we really don't comment on any ongoing cases such as the skinny label, but happy to provide whatever we can in the future as we get material updates.

We have reached the end of the question-and-answer session, and I will now turn the call over to Aaron for closing remarks.

Again, thank you, everybody, for joining us on such short notice. A lot to talk about today. We're excited about the future of Amarin. We look forward to providing you all with future updates. And until then, have a good day. Thank you.

This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.