AMRN Amarin Corporation plc

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Amarin Corporation plc Q3 F2026 Earnings Call Transcript

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Conference Operator
Operator
Greetings and welcome to the Ameren Corporation's third quarter 2026 results conference call. At this time all participants are on a listen only mode and a question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. And please note this conference is being recorded. I will now turn the conference over to your host, Mr. Devon Sullivan, Investor Relations. Sir, you may begin.
Devon Sullivan
Investor Relations
Thank you for your time and attention this morning as we discuss Ameren's 2026 third quarter financial results. On today's call are Aaron Berg, President and Chief Executive Officer, Pete Fishman, Chief Financial Officer, and Steve Ketchum, President of Research and Development and Chief Scientific Officer. Other members of the senior management team will be available as needed during the Q&A session following the prepared remarks. Aaron will provide a state of the company update. Pete will discuss the numbers and Steve will review recent medical and regulatory activities. Before we begin, I'd like to remind everyone that today's press release and related quarterly report on Form 10Q will be available on the investor relations section of the company's website, www.amroncorp.com, as well as a replay of this call shortly after its completion. Please be aware that during this call, we may make certain statements related to our business that are deemed forward-looking statements under federal securities laws. These statements are not guarantees of future performance, but rather are subject to a variety of risks and uncertainties. Our actual results could differ materially from expectations reflected in any forward-looking statements. Additionally, we assume no obligation to update these statements as circumstances change. For discussion of the material risks and important factors that could affect our actual results, please refer to our SEC filings which are available either on our company website or the Security and Exchange Commission's EDGAR system. With that said, I'd now like to turn the call over to Ameren's President and CEO Aaron Berg. Aaron, please go ahead.
Aaron Berg
President and Chief Executive Officer
Thanks, Devin, and thank you all for joining us today. As we approach the end of the year, I want to take the opportunity to highlight all that we've achieved, what lies ahead, and most importantly, how we continue to hold ourselves accountable to the standard of delivering value to our shareholders. As you can see in our press release, through the hard work of our team, the support of our commercial partners, and the enduring clinically validated efficacy of the SEPA, the momentum we experienced in the first half of 2026 continued through the third quarter across multiple fronts, including profitable third quarter results, reductions in our expense profile, continued positive operating cash flow, a stronger cash position and zero debt. Our outlook for the full year remains positive. Our partners are expanding the global reach of ASEPA and VASCEPA and driving double digit in market demand growth. We've also maintained our US leadership position in a highly competitive IPE space. We also announced exciting news earlier this week regarding clinical trial results, which may further add to our continued work on broadening our understanding of ASEPA's potential beyond cardiovascular care. And we'll touch on that shortly. As of September 30th, 2026, through our exclusive agreement with Recordati, the SCEPA was commercialized in 11 countries in Europe. And in October, the SCEPA launched in Poland on a private pay basis. In-market demand in Europe for Vescapa under the Recordati partnership rose by an estimated 68% in Q3 2026 compared to the same period last year. Spain, UK, and Italy continue to produce strong results which are helping to build a foundation for future growth as pricing, reimbursement, and commercialization efforts continue across the broader territory. Recordati has been an outstanding partner. While we're still in the early stages of the partnership, their execution and investment are driving momentum materially above historical European growth rates achieved by Ameren prior to the licensing transaction. With the rights to commercialize Vescapa across 59 countries, a deep heritage in cardiovascular disease and extensive commercial capabilities throughout Europe, Recordati is unlocking opportunities beyond our reach in a region with substantial untapped potential. Combined with intellectual property protection through 2039, we have a long runway to create value together. Across our combined global partner network, in-market demand for Vestipa rose by an estimated 55% in Q3 compared to the same period last year, reflecting continued in-market demand growth. were continuing to support our local partners in preparation for launches in Singapore and South Korea in early 2027. And with additional regulatory approvals and market launches across Southeast Asia. We maintained our leading position in the US IPE market with a 47% share while continuing to manage the business profitably. Pricing remains competitive, but our commercial discipline focus and efficiency continue to support our position. We continue to expect to maintain our exclusivity with key payers through the end of 2026 and expect U.S. volumes to remain stable through year end. As background changes in product exclusivity are part of the normal cadence of our U.S. commercial business. At the same time, Our strengthened operating infrastructure gives us greater flexibility to be selective as we evaluate opportunities and elect to move forward only when the economics make sense and support our profitability objectives. I'll now turn the call over to Pete Fishman, our Chief Financial Officer, who will go over our results.
Peter Fishman
Chief Financial Officer
Pete? Thanks, Aaron. We recorded our first profitable quarter in two years, reflecting the benefits of our completed restructuring as well as our company-managed U.S. and fully partnered international commercial model. Our third quarter performance demonstrated continued progress against our core priorities, supporting international in-market growth partners maintaining our leadership position in the US IPE market, establishing a significantly lower go forward cost base and strengthening our overall financial position. Total net revenue in the third quarter of 2026 was 39.6 million compared to 49.7 million in the third quarter of 2025. This consisted of total product revenue of 36.9 million compared to $48.6 million and licensing and royalty revenue of $2.7 million up from $1.1 million. U.S. product revenue was $28.5 million compared to $40.9 million in last year's third quarter. The decrease reflected lower net selling prices associated with changes in customer mix driven largely by generic competition. while pricing remains competitive, continued volume strength combined with operating efficiencies supported the US businesses ongoing profitability and cash generation. In Europe, third quarter product revenue declined to 3.7 million from 4.1 million under our partner model. Rest of the world product revenue rose to 4.7 million from 3.6 million in the prior year period reflecting continued commercial investment and execution by our partnership network. In-market demand across Europe rose by an estimated 68% from last year's third quarter, with rest of the world's in-market demand rising an estimated 46%. I'd like to briefly address the relationship between our international product revenue and in-market demand. We are encouraged by the in-market demand growth of Vesipa Veskepa across Europe and the rest of the world. New market demand provides a more direct view of the underlying growth of our international business, and we expect this growth to contribute to increased partner supply purchases and related revenue over time as our partnered international commercial model matures. The timing and level of these purchases will continue to reflect partner inventory levels and ordering patterns. and may not grow at the same rate as in-market demand in any given period. Because partner purchases can vary quarter to quarter, we believe a trailing 12 month view provides helpful context alongside quarterly comparisons. On that basis, international in-market demand increased an estimated 59% compared with the preceding 12 month period, reflecting sustained growth beyond any single quarter. Over time, we expect international product revenue to be best evaluated on this same basis. Cost of goods sold in the third quarter declined to $23.4 million from $27.5 million in the prior year period. We used the weighted average cost of our inventory to calculate cost of goods sold, which is influenced by API purchases, US sales volumes, and the size and timing of supply shipments to our international partners. Our Q3 results reflect the early benefits of our renegotiated supply contracts, which contributed to a sequential gross margin improvement, excluding write-offs of approximately 2.3 percentage points, despite continued US pricing pressure. While we expect our cost per unit to decline over time, the benefit will flow through gradually and Gross Margin may vary from quarter to quarter based on sales mix and the timing and volume of partnerships. Inventory management remains a high priority and our reduced inventory levels reflect our commitment to discipline working capital management that aligns supply levels with demand. For perspective, inventory has declined by 31% from Q4 2024. underscoring our progress in optimizing inventory and reducing the capital tied up in the business, contributing to our approved operating cash flow. Total operating expense declined by 44% from last year's third quarter, driven largely by a 27% decline in SG&A and no restructuring expenses during the quarter compared to 9.4 million last year, while R&D remained stable. Excluding restructuring costs, Total operating expenses declined by 22%, reflecting the lower go-forward cost structure established through our restructuring, which we intend to maintain through continued spending. Net income for the quarter was $245,000, or less than $0.01 per share, compared to a net loss of $7.7 million, or $0.02 per share, in last year's third quarter. We generate positive operating cash flow for the third quarter of $9 million. Through the first nine months of 2026, operating cash flow totaled $22 million compared to cash outflow of $9 million during the prior year period. We continue to expect positive operating cash flow for the full year. We ended September with cash and investments $324 million, an increase of $21 million from year-end 2025, and remain debt-free. That said, I'll turn things back to Aaron. Thanks, Pete.
Aaron Berg
President and Chief Executive Officer
As our global footprint continues to expand, the work of our medical affairs, regulatory, and R&D teams becomes increasingly important. Their efforts have resulted in a total of 28 publications inclusive of abstracts, posters, and articles this year to date. Beyond that, these teams provide expertise that supports our commercialization partners worldwide. from navigating local regulatory requirements and expanding the evidence base for icospin ethyl to engaging scientific leaders, supporting reimbursement discussions, and preparing for successful launches. Before turning things over to Steve Ketchum, Ameren's Chief Scientific Officer, I want to provide some background on an exciting recent development related to the exploratory use of a SEPA as an adjunct to standard of care and treating a defined population of colorectal cancer patients. The top line results from the investigator-initiated EPA for Metastasis Trial 2 or EMT2 Phase 3 trial using Vesepa were presented at this year's European Society for Medical Oncology in Madrid, Spain this past weekend. Importantly, the investigational medicinal product used in EMT2 was Vesepa, in the same dosage utilized in the landmark reduced cardiovascular outcomes trial that produced a 25% relative risk reduction in major adverse cardiovascular events. While these results provide a foundation for exploring the potential role for icospin ethyl in cancer care, our focus now is on working with our team to better understand the opportunity and its potential to benefit patients. to provide additional perspective on this trial and more broadly, scientific, medical and regulatory activities supporting our global growth strategy. I'll now turn the call over to Steve Ketchum. Steve.
Steven Ketchum
President of Research and Development and Chief Scientific Officer
Thank you, Aaron. This quarter was marked by several important scientific and medical affairs accomplishments that continue to reinforce the value of the SEPA while expanding our understanding of the broader biology of highly purified EPA. We maintained a strong presence at the European Society of Cardiology Congress, where five investigator-led presentations further strengthened the growing body of evidence supporting icosapent ethyl. These presentations included new analyses from Reducit, mechanistic research exploring the effects of EPA across multiple cardiovascular risk pathways, and data evaluating long-term outcomes, treatment adherence, Lipoprotein A, coagulation biomarkers, and other biological mechanisms that may contribute to the benefits observed with IPE. Importantly, EFC also featured the inclusion of icosapent ethyl within the newly issued guidelines for the management of cardiovascular disease and chronic kidney disease in collaboration with the European Renal Association, reinforcing the role of icosapent ethyl as an evidence-based treatment option for appropriate high-risk patients and underscoring its continued relevance in contemporary cardiovascular care. Beyond our own data, and as Aaron mentioned, investigators from the University of Leeds and other institutions in the UK presented results from the EPA for Metastasis Trial 2, or EMT2, this past weekend at the ESMO Congress in Madrid. EMT2 was a randomized, double-blind, placebo-controlled, investigator-initiated Phase III study evaluating a highly purified ethyl ester form of EPA as an adjunct to standard of care treatment in patients undergoing liver resection for colorectal cancer liver metastases. The study was sponsored by the University of Leeds. and enrolled 448 patients who were randomized to receive either vasepa or placebo beginning prior to liver surgery and continuing for up to four years after liver surgery. The pre-specified and statistically powered key study endpoints were progression-free survival and overall survival. Importantly, while the primary endpoint of progression-free survival was not met, and the study demonstrated an improvement in the key secondary endpoint of overall survival. A statistically significant 32% lower hazard of death, which is a meaningful finding in a patient population where up to 60% of patients may experience disease recurrence within two years following surgery. These findings represent an important contribution to the scientific understanding of IPE and warrant continued evaluation and discussion by the research community. Notably, EMT2 utilized the same vasepa clinical formulation and dose of icosapent ethyl or IPE used in Reducit. While cardiovascular disease remains our approved indication and our primary focus, findings from EMT2 add to a growing body of evidence suggesting that IPE may exert and many others. Over the past several years, research has increasingly suggested that EPA may influence mechanisms associated with inflammation, oxidative stress, thrombosis, cellular signaling and vascular biology. Publications related to omega-3 fatty acid use for colorectal cancer prevention, treatment and DORE mechanisms of action have reported several biologically plausible hypotheses, including incorporation of EPA in colonic or colorectal tissue, direct anti-inflammatory or anti-neoplastic activity of prescription IPE and potential augmentation of host anti-tumor immune surveillance through effects on the gut microbiome. These potential mechanisms remain investigational and require further analyses from EMT2 and from new research. Of note, recently an investigator-initiated mechanistic study from the Massachusetts General Hospital in Boston, Massachusetts, as well as other institutions, published in the American Journal of Clinical Nutrition in June 2026, found that treatment with the cepa icosapenethyl substantially increased incorporation of marine omega-3 fatty acids, particularly EPA, into colorectal tissue. While much remains to be understood, findings from studies such as REDUCE-IT, the growing body of mechanistic research, IIT research, and now EMT2 continue to reinforce the unique and increasingly differentiated profile of highly purified IPE supporting continued scientific investigation into the broader biological effects of prescription IPE and its potential role in areas of significant unmet medical need. Looking ahead, we remain committed to advancing the science of IPE through collaboration with leading academic investigators around the world. We have just seen the EMT2 results and we will continue to collaborate with Professor Hull and the University of Leeds Research Group to further evaluate the data and a path forward for Ameren. We are also excited about the upcoming 2026 American Heart Association scientific sessions where investigators will present new data related to lipoprotein A, an area of increasing interest within cardiovascular medicine. More than a decade after REDUCE-IT was initiated, Investigators continue to generate new insights into the effects of highly purified IPE. While many questions remain, the breadth and consistency of the data continue to strengthen our understanding of icosapent ethyl and its potential impact on human health. With that overview of our scientific progress, I'll now turn the call back to Aaron.
Aaron Berg
President and Chief Executive Officer
Thanks, Steve. Our third quarter results demonstrate that the transformation of our business is translating into tangible, operational, and financial benefits. We've expanded our global footprint and look forward to a greater global presence in 2027. With a significantly lower cost base, improving supply economics, and disciplined working capital management, we've generated four consecutive quarters of positive operating cash flow and strengthened our debt-free balance sheet. While U.S. pricing pressure and the timing of partner orders continue to influence revenue, growing international in-market demand reinforces the opportunity ahead. And the added potential opportunity for Vesipa, reflected in the EMT2 trial results, only adds to our optimism. We enter the final quarter of 2026 from a position of strength, focused on sustaining positive cash generation, supporting our partners' growth, and building long-term shareholder value. In parallel, the progress we've made in reshaping Ameren has put us in a stronger position than at any point in our recent history to deliver value to our shareholders. Building on that and guided by a clear mandate to maximize shareholder value, we continue to work closely with Barclays, our exclusive financial advisor and remain focused on working through these efforts in a timely and disciplined manner. These discussions and their potential outcomes will inform the timing, scale and prioritization of future capital deployment activities such as a share repurchase. And with that operator, let's open the call to questions from our analysts.
Conference Operator
Operator
Thank you. Ladies and gentlemen, at this time we will be conducting our question and answer session. If you wish to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue and you may press star 2 if you wish to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we poll for questions. Thank you. Our first question today is coming from Jessica Phi with JP Morgan. Your line is live.
Jessica Fye
Analyst, JPMorgan
Hey guys, good morning. Thanks for taking the question. I didn't catch the branded prescription growth that usually comes in the press release this quarter. Can you comment on that? How do we reconcile US script volume growth with the decline in US revenues year over year? Thank you.
Aaron Berg
President and Chief Executive Officer
Hi, Jess. Thanks for joining us. I appreciate the question. The volume for branded Visipa was stable. It was relatively flat.
Aaron Berg
President and Chief Executive Officer
The downward impact on revenue was due to pricing pressure.
Jessica Fye
Analyst, JPMorgan
And then can you just give us a little bit of a sense about how to think about the U.S. price trajectory over the coming kind of quarters?
Aaron Berg
President and Chief Executive Officer
I'll turn it over to Pete to address that.
Peter Fishman
Chief Financial Officer
Yeah. When we look at the U.S. pricing, you know, over the rest of this year, as we've talked about, we do expect to maintain our exclusives. So expect the pricing to remain relatively consistent through the end of this year. Well, we haven't given guidance on 27 and we're still waiting for final confirmation on how the exclusives will look like going into 2027. We have seen that continued pricing pressure over previous years and we would anticipate that to continue into 27.
Jessica Fye
Analyst, JPMorgan
Okay, thank you.
Aaron Berg
President and Chief Executive Officer
Thank you, Jess.
Conference Operator
Operator
Thank you. Our next question is coming from Paul Choi with Goldman Sachs. Your line is live.
Paul Choi
Analyst, Goldman Sachs
Thank you. Good morning and thanks for taking our questions. I want to ask on where you're able to comment on any updates in terms of reimbursement and coverage in major European markets. Any additional color there would be helpful. And my second question is, in terms of thinking about the additional therapeutic applications for IPE, sort of what criteria are you considering here and are you looking for a partner to help co-fund future development? Thank you.
Aaron Berg
President and Chief Executive Officer
Hi, Paul. Thanks for joining us. Thanks for the questions. Regarding reimbursement in Europe, we've been very encouraged by the approach that Recordati is taking. as we mentioned the partnership is for 59 countries they not just focusing on the the major markets in Western Europe but much broader than we at Ameren could have ever executed on our own so they're they're making progress beyond where we've already commercialized. In fact, as we mentioned, they just launched in Poland. It's public that there's activity going on with France. It's a very lengthy process. We're certainly optimistic and we believe we have the right partner that certainly can advance BESCAPA well beyond the markets where we're already commercialized. So there's a lot of activity going on. There's a lot going on to explore the potential in certain markets. while at the same time trying to find a way to enter those markets. As we get more clarity that we can speak to, we'll certainly do that, but we're very pleased and again in particular that they are going well beyond where we would have gone as average on our own. Regarding the potential other clinical applications, EMT2 certainly brings that question to the forefront. Regarding that We just saw the data ourselves. We're very excited about that data, as should patients, because the second most prevalent cause of cancer death is colorectal cancer globally. So the unmet need is there, and these are very, very sick patients that were studied. We have a lot to learn about the data and that's what Steve has mentioned is that we'll be working with Dr. Hall as well as the University of Leeds. We'll continue collaborating with them to see where we go at the same time from a commercial perspective assessing what value there is for us. That's the approach we'll take with any other potential therapeutic application. and that is what's the commercial opportunity? What's the unmet need? What data already exists? What can we do to protect it? A lot of questions that we ask. We're fortunate that we have a molecule that has such broad application and there's probably more we don't know still about what this drug can do that we do know and certainly EMT2 is a testament to that. So once we identify more about which path we go we'll also identify whether we share in that how we approach it certainly we will be very disciplined managing the risk and the opportunity at the same time but once we know more we'll certainly report on that that's a good question thank you thank you apologies if you cannot hear me can you hear me now we can oh thank you so much ladies and gentlemen as we have no further questions in the queue at this time I would like to turn the call back over to Mr. Berg for any closing remarks yeah once again thank you all very much for joining us thanks for your attention to Ameren and we'll look forward to keeping you apprised as our of our progress as we move forward thank you have a good day
Conference Operator
Operator
thank you ladies and gentlemen this does conclude today's call you may disconnect your lines at this time and we thank you for your participation