Amarin Corp Plc Q2 2026 Earnings Call

Morning, and welcome to Amarin Corporation's conference call to discuss its second quarter 2026 financial results. At this time, all participants are in a listen-only mode. 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. Please note this conference is being recorded. I would now like to turn the conference call over to Devin Sullivan, investor relations for Amarin.

Thank you for your time and attention this morning as we discuss Amarin's 2026 second quarter financial results. On the call today are Aaron Berg, President and Chief Executive Officer, Steven Ketchum, President, R&D, and Chief Scientific Officer, and Peter Fishman, Chief Financial Officer. Other members of the senior management team will be available as needed during the Q&A session that will follow these prepared comments. Aron will provide a state of the company, Steve will provide an update on recent medical and regulatory activities, and Pete will walk us through the numbers. Before we begin, I'd like to remind everyone that today's press release and related quarterly report on Form 10-Q will be available on the investor relations section of the company's website, www.amarincorp.com, as will 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 a 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 Securities and Exchange Commission's EDGAR system. With that said, I'd now like to turn the call over to Amarin's President and CEO, Aaron Berg. Aron, please go ahead. Thanks, Devin.

Thank you all for joining us today. Q2 2026 marked an inflection point for Amarin, highlighting the one-year anniversary of our dual commercial strategy that combines continued execution of our U.S. business with a fully partnered international commercial platform. The successful implementation of these actions has resulted in a scalable business model while defining a clearer path towards sustainable growth and profitability. We're seeing a promising early-stage international sales trajectory in a number of markets where there remains significant unmet need and long-term potential for VASCEPA while preserving a leading U.S. presence for VASCEPA, supported by a financial foundation that includes a growing cash position and no debt. Our restructuring activities are now complete, resulting in a significantly lower cost base. This refined organizational structure and expense framework will enhance our ability to efficiently execute our long-term growth strategy.

As you may have noticed in our press release, we're now able to provide an outlook for certain key metrics for full year 2026, reflecting the clarity afforded by our new operating model and the strong partnerships that make up its foundation. This underscores how far the business has progressed in the past year while validating our global go-to-market initiatives and reinforcing the continued outstanding execution of our talented, committed team. As of June 30th, 2026, VASCEPA was commercially available in 22 countries via both our fully partnered international commercial strategy and company-managed U.S. presence. Our accelerating international growth is being driven primarily by our exclusive license and supply agreement with Recordati, which covers 59 countries across Europe, as well as our six other commercial partnerships in the rest of the world that cover regions including Canada, China, Israel, the Middle East, Asia, Australia, and New Zealand.

Across this combined global partner network, in-market demand for VASCEPA rose by 59% in cumulative year-over-year volume as of June 30th, compared to the same period last year. As of the end of Q2, VASCEPA is commercialized in 11 countries in Europe, including a recent launch in Romania, and Recordati continues to invest meaningfully with pricing, reimbursement, market access, and adoption advancing in numerous additional countries across the licensed territory. Under Recordati's leadership, VASCEPA is at an early but promising stage of commercialization in Europe's large cardiovascular market, where the disease affects an estimated 62 million people and carries an annual economic burden of approximately EUR 282 billion across the European Union. In-market demand in Europe for VASCEPA under the Recordati partnership rose by 69% in Q2 2026 from Q2 2025.

Spain and the U.K., though early, are leading commercial adoption, providing a strong foundation for future growth as pricing, reimbursement, and commercialization efforts continue across the broader territory. In Italy, where Recordati has one of the country's most established pharmaceutical commercial organizations, VAZKEPA launched with significant commercial support and has demonstrated strong early uptake. VAZKEPA is positioned by Recordati as a priority brand in its cardiovascular portfolio, backed by an expanded cardiovascular commercial infrastructure across Europe, including dedicated field representatives, medical science liaisons, and marketing investment. In its 2025 annual report, Recordati referred to VAZKEPA as a best-in-class treatment option that complements its existing cardiovascular portfolio, is supported by a robust clinical data package, and makes a meaningful impact for cardiovascular patients with residual cardiovascular risk.

While driving utilization in launch markets, Recordati is actively progressing pricing, reimbursement, and market access across additional territories, building a meaningful base for long-term royalty and milestone growth as additional countries come online. While very early, the commercial performance since the June 2025 licensing transaction is encouraging in that Recordati's established cardiovascular infrastructure, broader geographic footprint, and tremendous execution have unlocked substantially greater value from VAZKEPA than would have otherwise been possible had Amarin continued VAZKEPA commercialization throughout Europe alone. The commercial momentum generated by Recordati thus far materially exceeds historical European growth rates achieved by Amarin prior to the licensing transaction. As a reminder, European markets each follow their own regulatory process for pricing, reimbursement, and market access, so commercial launches can progress at different speeds and under varying requirements across countries, despite an overarching EU framework.

In the U.S., our core business continues to serve as a highly efficient, cash-generating base, with VASCEPA retaining a leading position in the icosapent ethyl market despite ongoing generic pressure. We continue to expect to maintain our exclusives with key payers through the end of 2026. The overall U.S. IPE market, based on third-party data, rose by 3% in Q2 2026 compared to Q2 2025. VASCEPA's share of the market rose to 48% as of June 30th, 2026, up from 43% in the same period last year. Despite continued pricing pressure, VASCEPA-branded prescriptions increased 14% year-over-year in the second quarter of 2026, reflecting continued commercial execution in a competitive market. We expect U.S. volumes to remain stable through the end of 2026. Outside of Europe and the U.S., we continue to support our partners in advancing regulatory submissions in various other countries across Asia.

We've recently received approvals in Singapore and South Korea and look forward to the launches in these territories in 2027. As our international footprint continues to expand, the work of our medical affairs, regulatory, and R&D teams becomes increasingly important. Beyond supporting Amarin's own scientific objectives, these teams provide critical expertise to our commercialization partners around the world to contribute to our joint success, helping them navigate local regulatory requirements, continuing to contribute to an already robust library of scientific evidence supporting the benefits and unique attributes of icosapent ethyl, engage with key scientific leaders, support reimbursement discussions, and prepare for successful product launches. Through scientific exchange, congress participation, publication support, medical education initiatives, and ongoing regulatory collaboration, these teams help ensure that our partners have access to the latest data and insights supporting VASCEPA as they work to improve access for patients in their respective markets.

To provide additional perspective on the scientific, medical, and regulatory activities supporting our global growth strategy, I'll now turn the call over to Steven Ketchum. Steve? Thank you, Aaron. Supporting our global commercialization strategy is an experienced medical affairs, regulatory, technical operations, and R&D organization that works closely with our partners throughout the product life cycle, from regulatory submissions and scientific exchange to market access and commercial launch.

Together, these teams help advance the science behind VASCEPA and VAZKEPA while enabling successful regional commercialization across our global partner network. Our commitment extends well beyond supplying product. We believe sustained scientific leadership is one of the most important ways we create value for patients, healthcare providers, and our partners. More than seven years after the landmark REDUCE-IT results and more than six years after the U.S. approval of VASCEPA for cardiovascular risk reduction, we continue to invest in meaningful scientific research that expands our understanding of cardiovascular risk and reinforces the role of high-dose VASCEPA in contemporary clinical practice.

Beyond generating new evidence, our teams work closely with partners through publication initiatives, scientific congresses, key opinion leader engagement, launch planning, regulatory support, and medical education, helping ensure they are equipped with the latest evidence to support successful commercialization and expand patient access across global markets. That commitment is reflected in a steady cadence of scientific advancements, guideline recognition, and partner-led educational initiatives that continue to strengthen the global evidence base for high-dose VASCEPA icosapent ethyl. In May, we announced new data from a post-hoc analysis of the REDUCE-IT trial that was presented at the European Atherosclerosis Society, or EAS, Congress in Athens, Greece. The analysis, conducted in the REDUCE-IT placebo arm, found that among statin-treated patients with elevated triglycerides, risk-weighted apolipoprotein B, or ApoB, more effectively identified patients who remained at increased residual cardiovascular risk compared with traditional lipid biomarkers.

These recent findings add to the body of evidence that many high-risk patients continue to face substantial residual cardiovascular risk despite statin therapy and highlight the potential value of more refined lipid metrics to better identify patients who may benefit from evidence-based treatment. Prior findings from REDUCE-IT have shown that VASCEPA consistently reduced major adverse cardiovascular event risk across the spectrum of lipoprotein(a) levels, including in patients with elevated lipoprotein(a), an increasingly recognized contributor to residual risk. These previously published findings suggest that any future benefits from emerging lipoprotein(a)-lowering therapies may be complementary to the established cardiovascular risk reduction demonstrated with VASCEPA. This growing body of evidence complements the continued recognition of high-dose icosapent ethyl in leading international treatment guidelines.

Both the 2026 ACC/AHA Multi-Society Dyslipidemia Guideline and the more recently released ACC/AHA Multi-Society Cardiovascular Kidney Metabolic Syndrome Guideline formally recommend high-dose icosapent ethyl for appropriate high-risk patients. Together with recommendations from more than 70 medical societies worldwide, these endorsements underscore the strength of the evidence supporting VASCEPA and reinforce its important role in addressing residual cardiovascular risk. Looking ahead, we remain committed to advancing the science that supports patients, clinicians, and our commercialization partners. Early next month, we will support our Australian partner, CSL Seqirus, at the Cardiac Society of Australia and New Zealand, or CSANZ, annual scientific meeting in Sydney. As one of the region's premier cardiovascular congresses, CSANZ provides an important forum for scientific exchange and physician education.

During the meeting, CSL Seqirus will sponsor a medical education session entitled "Transforming Secondary Prevention After MI: Imaging Residual Risk and Targeting What Remains," featuring Professors Peter Psaltis and Adam Nelson, in addition to presenting a mini oral abstract entitled "Benefits of icosapent ethyl in Patients with Prior Peripheral Artery Disease REDUCE-IT PAD." We are proud to support these efforts as part of our broader commitment to advancing cardiovascular science and helping our partners educate clinicians with the latest evidence. Later in August, we will also participate in the European Society of Cardiology Congress in Munich. As one of the world's largest cardiovascular meetings, bringing together more than 33,000 healthcare professionals from nearly 170 countries, ESC provides an important platform to share new scientific findings.

We are pleased to have five scientific abstracts accepted, including multiple new REDUCE-IT analyses and mechanistic data that continue to deepen our understanding of the clinical benefits of high-dose VASCEPA. We also anticipate the release of the European Cardiovascular Kidney Metabolic Guideline during the ESC meeting, representing another important milestone for cardiovascular care and providing an additional opportunity to engage with the global scientific and clinical community. Our continued investment in science reflects a simple belief: strong clinical evidence drives better patient care while creating long-term commercial opportunity. Beyond supporting current commercialization efforts, we continue to evaluate cost-effective opportunities to further advance the science of icosapent ethyl and explore potential future lifecycle management initiatives. While these efforts remain in the early stages and no development decisions have been made that are appropriate for public disclosure today, we believe disciplined scientific innovation remains an important component of long-term value creation.

We will communicate developments when there are meaningful updates to share without setting unrealistic expectations. By continually expanding the evidence base and providing our partners with ongoing scientific, regulatory, technical, operational, and medical expertise, we are helping accelerate global access to VASCEPA and VASCEPA Support successful commercialization across international markets, ultimately improve cardiovascular outcomes for patients worldwide. With that overview of our scientific progress and partner support activities, I'll turn the call back to Aaron.

Thanks, Steve. Before turning things over to Pete, I want to emphasize that the story we've authored is functioning as intended, with each chapter of execution adding momentum that supports the next phase of growth. We'll continue to advance our organic growth initiatives and execute with a high level of financial and operational discipline. Additionally, we continue to work closely with our exclusive financial advisor, Barclays, as we actively evaluate additional potential opportunities to enhance shareholder value. Our commitment to patient care remains the foundation of everything we do, shaping our strategy, guiding our decisions, and directing our investments. With that, I'll now turn the call over to Pete to take us through the numbers.

Thanks, Aaron. As Aaron mentioned, the benefits of our dual sales model and now completed restructuring plan are becoming increasingly clear with execution against three key priorities: advancing international growth through our partners, operating with a significantly lower cost base, and continuing to strengthen cash generation. In summary, European product revenue increased from Q1 2026, total operating expenses, excluding restructuring charges, materially declined from Q2 2025. We also generated positive cash flows for the third consecutive quarter and improved our cash position by $12 million from year-end 2025. Total net revenue in Q2 2026 was $42.2 million, compared to $72.7 million in last year's second quarter, which included a $25 million upfront payment associated with the commencement of the Recordati transaction. Product revenue was $39.1 million, compared to $46.6 million.

By geography, U.S. product revenues declined to $32.2 million from $36.5 million in Q2 2025, driven by ongoing pricing pressure in the competitive generic market, partially offset by higher product volumes. Importantly, despite this pricing pressure, the U.S. business remains profitable and continues to generate cash. Second quarter product revenue in Europe was $5.4 million under our new partner model and consisted entirely of supply shipments to Recordati. This compared to $6.6 million in the second quarter of 2025 under our previous sales model. Lower revenue, despite the increased in-market demand of 69%, reflected the transition to Recordati. Q2 2026 European revenue increased 11% from Q1 2026 and was up by 140% from Q4 2025. We are encouraged by this early momentum.

Rest of world revenue in Q2 2026 was $1.4 million, down from $3.5 million in the prior year period, reflecting normal variances across multiple geographies as these respective markets continue to develop. Cost of goods sold in Q2 2026 rose 22% to $27.2 million from $22.4 million due to increased product volumes, primarily associated with regaining an exclusive PBM relationship in the U.S. beginning in Q3 2025. Lower operating expenses reflected the success of the now completed global restructuring, which we commenced in mid-2025. The decrease was in line with the previously announced approximately $70 million in annual cost savings and established a more efficient operating expense baseline. In Q2 2026, total operating expenses declined by 59%, or $39.3 million to $27 million. Excluding the restructuring charge of $22.8 million in Q2 2025, total operating expenses decreased 38% from prior year period.

We incurred no material restructuring charges in Q2 2026. Selling general and administrative expense for Q2 2026 was $22.2 million, a 43% decline from $38.7 million one year ago. R&D expenses were in line with our ongoing commitments and our partners' ongoing expansion into new markets. R&D reflects our commitment to global regulatory support and to the science underlying our global branded products. Our operating loss in the second quarter narrowed to $12 million from an operating loss of $16 million in last year's second quarter. Despite the increase in cost of goods for the quarter, we narrowed our operating loss by 25%. Turning to the balance sheet, we ended the quarter with cash and investments of $314.6 million, up from $303 million at year-end 2025, with no debt and working capital of $439 million.

Importantly, we generated $7 million of positive cash flow from operations in the second quarter, our third consecutive quarter of positive cash flow, and we continue to expect positive cash flow for full year 2026. Given this stronger cash position and continued cash generation, I also wanted to briefly address our previously authorized share repurchase program. We recognize that many shareholders are eager for an update, and we appreciate your continued interest. As we have discussed previously, the U.K. High Court approval obtained in connection with the authorization remains in effect through Q2 2029. Since obtaining that approval in 2024, the business has evolved considerably. Today, we are operating from a stronger financial position with improved cash generation. We understand our responsibility to deploy capital in a way that benefits shareholders.

Capital deployment can take a number of forms, and we will continue to evaluate our options carefully and provide updates if and when there are material developments. Disciplined inventory management remains a high operational priority and an important driver of cash flow and overall business health. As of June 30, 2026, inventory declined by $19.5 million from March 31, 2026, and by $31.8 million from December 31, 2025. This reflects our multi-year approach to purchasing API at the appropriate time, considering manufacturing lead times, supply continuity requirements, and evolving demand trends across our markets. This discipline allows us to support expected commercial demand while avoiding unnecessary working capital tied up in inventory. The business continues to strengthen, supported by key milestones achieved over the past year.

Under our new operating model, we are operating with a leaner cost structure, working capital discipline, and greater financial flexibility to support our U.S. profitability and sustainable international growth through our partners. I now ask the operator to open the call to questions.

Certainly. At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like 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. Your first question for today is from Paul Choi with Goldman Sachs.

Hi. Good morning, and thanks for taking our questions. Aaron, first one is just on the reimbursement landscape in Europe. Appreciate that it's country by country, but in terms of the major markets, can you maybe give us an update on what still needs to be done in the various key geographies in Europe? My second question for Pete is just on cost of goods came in a little bit higher than I think the street had been modeling. Can you maybe just help us understand if this is the sustainable rate that you're expecting given volume growth that you're anticipating here on a go-forward basis? Thanks for taking our questions.

Hi, Paul. Thanks for the questions, appreciate it. Thanks for joining us. Regarding Europe and reimbursement, as you noted, it's a different pace and different rate across all the countries. Where we've launched or, and now Recordati commercializing primarily U.K., Spain, Portugal, as well as now getting off the ground in Italy. The reimbursement is there, always looking for ways to improve regionally. Given the growth and in-market demand, we're very pleased with where we are and how Recordati has made commercializing VASCEPA a priority, and they even noted the strong growth yesterday themselves in their earnings call. They're also evaluating a number of other countries. Ultimately, we'd like to see the ability to launch in France.

That would be, of course, sometime in the future, but obviously, we have confidence in our partner to be able to do something there, but we just don't have an update at this time. As you know, it's a lengthy process there. They have partnered with us for 59 countries. They're exploring a number of countries that we, as Amarin, would never even have considered, and some of those are sizable markets, and hopefully, we'll see how that plays out and we can get reimbursement in those countries and ultimately launch as well. Off the ground early. Back to Italy, that's a very big omega-3 market. It certainly is one that Recordati knows extremely well, very established, competent cardiovascular organization. They're off the ground strong. The more they get regional reimbursement and favorable reimbursement there, we're excited about what they can do there.

Overall, we're pleased with Europe. A lot of work to do, very early, 15-year partnership, as you know. Right now, we're extremely encouraged. Pete, do you want to touch on the COGS? Thanks, Aaron. As you know, COGS is calculated using a weighted average cost of our inventory on hand, which is primarily driven by our API for the volume sold in the quarter. When you look at the comparison from Q2 2026 to Q2 2025, the increase is due to regaining that PBM exclusive, which was effective in Q3 2025. When you look at Q3 compared to Q2 in 2026, that material variance, and also when you look at Q3 2025 to Q3 2026, that material difference, you should start to see it level off. You're right that the primary driver is that increase in volume.

As we've talked about in the past, we've spent the last few years renegotiating our supply agreements. That's enabled us to drive our inventory levels down to more appropriate levels. It's also allowed us to manage the cost structure in our purchasing. Great. Thank you. Thank you, Paul.

Your next question is from Jessica Fye with JPMorgan.

Good morning. Thanks for taking our questions. This is Aaron for Jess. On the licensing revenues of EUR 3.1 million in the second quarter, curious if you're seeing any revenues from Recordati starting to roll in here. If so, what should we expect those Recordati revenues to ramp up in the second half and beyond? Thank you. I'll comment on growth from an end market perspective, and then I'll have Pete talk about the revenue side of things.

As you know, we're not in the business to give revenue guidance, but Pete can comment on that. Obviously, the more that they grow in market demand, the greater the acceleration in revenue growth as well. The end market demand has been tremendous at 69% for Recordati for Europe. They just got started. We're encouraged by what that will do. Obviously, the more we can help them, the more they invest in end market demand, the more we'll drive revenue. Pete, do you want to comment on the numbers on revenue specifically? Yes. On the licensing revenue, that also includes royalty revenue. There is a portion of that that is made up from Recordati.

There was EUR 1.4 million in royalty revenue for the quarter, which is a growth from Q1. As you're seeing that in-market demand growth, you're also seeing product revenue growth of 11% from Q1 2026. We are seeing that growth. We're encouraged by the continued momentum, though early stages from Recordati. Yes, when you look at the licensing revenue line of EUR 3 million, there is a portion of that related to Recordati.

Thank you. Thank you. We have reached the end of the question and answer session.

I will now turn the call over to Aaron for closing remarks.

Thank you, operator. We continue to have strong confidence in our strategy. We've got optimism about the scale of the opportunities that lie ahead, long-term partnerships, a lot of untapped potential worldwide. Certainly, we have a tremendous product that continues to provide that benefit. We're executing extremely well. We've got enormous pride in our team and the commitment and the progress that we're making with this new strategy. We look forward to continuing to report those results to you. Thank you all for joining us today. Appreciate you taking the time. Look forward to keeping you apprised of our progress. Have a good day. This concludes today's conference, and you may disconnect your lines at this time.

Thank you for your participation.