Amarin Corporation PLC (AMRN) 2025 Q4 法說會逐字稿

Welcome to Amarin Corporation's conference call to discuss its fourth quarter 2025 financial results. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. (Operator Instructions) 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 Amron's 2025 fourth quarter and full year financial results. On the call today are Aaron Berg, President and Chief Executive Officer, and Pete 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. Turning to today's agenda, Aaron will provide a state of the company, and Pete will walk through the numbers.

Before we begin, I'd like to remind everyone that today's press release is available on the investor relations section of the company's website www.amerincorp.com, as will a replay of this call shortly after its completion. Our annual report on Form 10-k will also be available in the investor relations section of the website in the coming days.

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 Edger system.

With that said, I'd now like to turn the call over to Amarin's President and CEO, Aaron Berg. Aaron, please go ahead.

Thanks, Devin. 2025 was a year of substantial achievement for Amarin. The strategy we've been developing to transform our business model and expand the global market for our VASCEPA franchise took shape and began producing measurable results.

Mid-year, we established our exclusive long-term partnership with Record Ati to commercialize VASCEPA across Europe with the overarching goal of better capitalizing on the untapped potential of VASCEPA to tackle the growing challenge of cardiovascular risk worldwide.

This strategy was the catalyst for us to examine the entirety of our operations and identify areas where we could realize significant and durable efficiencies that would support this strategic pivot.

Our expectation is that this combination of a refined strategy via our relationship with Record Addi and enterprise-wide operating efficiencies generated by our global restructuring will result in a hole that is greater than the sum of its parts, allowing us to efficiently generate revenue and cash flow globally and position us to be a stronger, leaner operation. We are very pleased with the progress to date.

For a full year 2025, we achieved a significant reduction in our operating expenses, generated positive cash flow earlier than anticipated, and maintained a debt-free balance sheet and ample cash balance.

As of December 31, 2025, we realized approximately half of the estimated $70 million in total operating expense savings associated with our global restructuring plan and expect to achieve the full savings benefit from these initiatives by June 30, 2026 as planned. While there's still work to be done, we are operating from a much stronger position due to the hard work and dedication of our exceptional team.

The operational progress we made this year reflects their shared commitment to enhancing long-term shareholder value. Everything we do as a company is driven by our commitment to reduce cardiovascular disease as a leading cause of death.

With approximately $30 million total prescriptions written since the launch of VASCEPA in 2013 and a large and growing library of validating studies, analyses, and scientific evidence that support VASCEPA's ability to reduce cardiovascular events by 25% when added to a statin, we remain confident in the durability of our core franchise and its global growth potential.

In the US, VASCEPA has retained clear market leadership across all available icosapent ethyl products branded and generic, a remarkable achievement five years since the first generic product was introduced. We maintained all major managed care exclusives through 2025 and successfully regained exclusive status mid-year with a large national PBM.

Our continued revenue generation reflects the effectiveness of our commercial strategy as well as our success in maintaining market share leadership due to both accessibility and affordability.

We know from our experience with VASCEPA in the US that Europe offers a significant growth opportunity because of the growing awareness about lipid management protocols and the need for therapies that address cardiovascular disease, which is the number one killer globally and on the rise across the world.

While our team in Europe made very good progress in various markets. As we considered our options to address this promising opportunity for the future, it became clear that the best way to accelerate and maximize access to this large untapped market, where we have IP protection through 2039, was via a partnership with an established leader in cardiovascular disease in Europe.

Our exclusive long-term license and supply agreement with Record Addi, which commenced in Q3, 2025, includes commercializing VASCEPA across 59 countries with a focus in Europe. This agreement has significantly transformed our international commercial strategy into a fully partnered model comprised of seven parties and close to 100 countries.

This approach is designed to generate substantial economies of scale and offer significant revenue opportunities while providing extensive infrastructure and commercial experience. Record Addi is now fully managing European promotional activities for VSCO. As a result, we're providing this therapy with greater effectiveness and efficiency to an expanded international patient population.

I'd like to share with you some of the initial highlights from this agreement. Delivered immediate meaningful financial value, including a $25 million upfront cash payment for Record odd with eligible future milestone payments totalling up to $150 million with the first milestone payment contingent upon record oddi achieving annual net sales of $100 million.

Commercial momentum continues with both volume and in-market demand growing across all large markets. Commercialization was advanced in Italy, a key market, initiating sales efforts and building on Amron's strong pre-deal groundwork for pricing and reimbursement. Expanded patient access, including securing pricing and reimbursement in two additional countries, Austria and Slovenia.

The position for further European expansion with Record Addi actively evaluating additional launch opportunities and timing broadly across the full 59 country territory. Outside of Europe, our partners continue to make progress in their respective regions.

Of note, together with our partner Lotus, we secured two regulatory approvals in 2025, South Korea and Singapore, and are preparing to launch in these countries in the future.

We expect the regulatory reviews of previously submitted applications in Thailand and the Philippines will be significantly advanced by the respective local authorities across 2026, with new regulatory filings to be made in Vietnam and Malaysia this year.

Overall, the success of our partners is fundamental to our global strategy of making VASCEPA available to the millions of patients in need of cardiovascular risk reduction today. Supported by more than 500 peer reviewed publications, science is the foundation of everything we do.

Providing both us and our partners with robust, credible evidence to support confident decision making and long-term patient impact. It guides our decisions and underpins our continued investment in analysis that further explore and validate VASCEPA's ability to reduce major adverse cardiovascular events across diverse patient populations, further strengthening its established therapeutic value.

We ended 2025 having supported a total of 45 abstracts, posters, and papers that further expanded the body of knowledge for our product. Our most recent publications in late 2025 and 2026 include three reduce it post hoc analyses that were previously presented at major medical congresses.

We had two papers published online in the American Journal of Preventive Cardiology, or the AJPC. The first demonstrated that icosapent ethyl reduced cardiovascular risk in patients with baseline characteristics of cardiovascular, kidney, metabolic, or CKM syndrome.

The second showed that icosapent ethyl reduced the rate of cardiovascular events across the range of standard modifiable cardiovascular risk factors that included hypertension, diabetes, smoking, and hypercholesterolemia at baseline for established cardiovascular disease patients. A third paper published online in the European Journal of Preventive Cardiology or EJPC.

Demonstrated that icosapent ethyl treatment in the Reduces study was associated with fewer total hospitalizations and increased the chances of an individual living without hospitalization. We look forward to sharing more about this paper soon, which provides additional insights on the effects of icosapent ethyl on patient-centered measures of total disease burden.

In addition, we're preparing to attend the American College of Cardiology scientific sessions in New Orleans from March 28 to March 30, where we and our collaborators will present a new reduced patient subgroup analysis and additional mechanistic data on EPA's multifactorial biologic activities.

We expect to share more details as we approach the ACC conference. Building on the substantial body of evidence we've generated and supported this year, we're also encouraged by the ongoing progress across the complex lipid and lipoprotein research landscape.

Recent FDA breakthrough therapy designations highlight the growing recognition of the risks associated with elevated triglycerides, and the need to address them. Innovation is reshaping the future of cardiovascular care with promising research into multiple pathways, and as this landscape evolves, we believe VASCEPA remains uniquely positioned for sustained relevance and growth.

While multiple forces are shaping today's treatment environment, our perspective is straightforward. Currently available, proven, safe, and evidence backed therapies are often overlooked as attention shifts to new innovations, but it should not change the reality that some of the most effective treatment options are those that have consistently delivered meaningful outcomes over many years, including the CEA.

Such conviction is supported by two key factors. Firstly, the FDA's recent update the fenofibrate labelling marks a meaningful turning point in regulatory clarity. While fenofibrates remain approved to lower triglycerides in patients with severe hypertriglyceridemia. The updated label reflects what decades of outcomes data have shown.

Fibrates do not reduce cardiovascular events, even when added to statins. While fibates continue to be prescribed frequently for patients in conjunction with statins to reduce cardiovascular events, this clarification is helping reset expectations across the healthcare system and reinforcing a shift toward therapies supported by proven clinical outcomes, not simply biomarker changes.

Against this backdrop, VASCEPA stands apart as the only FDA approved oral therapy with indications for both severe hypertriglyceridemia and cardiovascular risk reduction, with the demonstrated ability to reduce the risk of major cardiovascular events by 25% when added to statin therapy in appropriate patients as shown in the Reduce it cardiovascular outcomes trial.

As prescribers and payers increasingly align decisions with evidence-based medicine, this differentiation becomes even more important. Especially with nearly half of all US adults affected by cardiovascular disease. Secondly, as research activity across lipids and lipoproteins expands, we believe it continues to highlight the role of established proven options such as VASCEPA.

As we mentioned previously, we're closely monitoring payer-driven step therapy dynamics as premium priced injectable triglyceride lowering therapies enter the market. In many cases, payers are already requiring patients to step through approved, established lower cost options before accessing newer agents.

Historically, this type of formulary design has driven broader use of proven oral therapies, and we believe a similar dynamic is likely to emerge in severe hypertriglyceridemia. Taken together, these developments reinforce our confidence in the global opportunity for the VASCEPA franchise, grounded in outcomes-based evidence.

All that said, we've entered 2026 with an established US therapeutic franchise that continues to deliver lifesaving results supported by industry tailwinds, emphasizing widely available, cost-effective treatments such as VASCEPA, as a crucial part of preventing cardiovascular disease in patients with elevated triglycerides.

We have what we view as a significant growth driver via our relationship with Record Addi that has strengthened our presence in Europe and helped define our fully partnered international commercial strategy. You've significantly lowered our corporate expense base and enjoy a financial position that ranks among the strongest in our recent history.

At the same time, the board and management, with the assistance of our exclusive advisor Barclays, will continue to explore value enhancing strategic opportunities. We've come a long way over the past year, addressing challenges and meeting opportunities head-on and emerging stronger. But I'll say it again, we still have much work to do. 2026 will be a pivotal year for Amron.

Working to defend our US franchise, working efficiently and effectively to expand our global presence through our international partnership model, and working to stay the course to unlock sustainable long-term value for shareholders. I'm confident that we have the right product, strategy, and team in place to meet these objectives and position the company for long-term success.

As the year progresses, we expect to be able to provide greater insight to our progress and look forward to sharing that with you. With that, I'll now turn the call over to Pete to take us through the numbers.

Thanks Aaron. Our results for 2025 reflected the initial success of our global restructuring plan, specifically with respect to optimizing our operations and creating a platform for sustainable, efficient growth. For the fourth quarter of 2025, total net revenue was $49.2 million compared to $62.3 million in last year's fourth quarter.

By geography, US sales declined 7% due to a decline in net selling price driven by proactive pricing to align with market dynamics. Looking ahead, we typically see the majority of the full year US decline in volume in the first quarter of the year based on annual changes for payers.

As we continue our transition of commercial activities to record Addi in the fourth quarter, product revenue for Europe was $2.3 million, including 900,000 in supply shipments to Record Addi. This revenue is generated at significantly lower cost compared to the $4 million of direct sales in the fourth quarter of 2024.

Once the transition is complete, Europe product revenue will come entirely from supply shipments to record adding. Rest of the world revenues were $3.1 million compared to $11.9 million in last year's fourth quarter. This variance was driven by the impact of $7.8 million in stocking orders in the last quarter of 2024 in advance market launches.

Importantly, we continue to see in-market demand growth across all launch geographies, evidenced by the year over year increase in our royalty revenue. While early in most markets, we are pleased by our partners' focus on expanding the reach of AIPA. In particular, we are encouraged by the commitment and results from the Recor Ati team, especially maintaining momentum during this transition.

And we look forward to accelerated in-market growth as they expand their commercial efforts and footprint. As a reminder, our partnered model will result in revenue variability quarter to quarter driven by the current scale of operations, as well as the impact of launch timing, in-market demand, and the structure of individual partnership agreements.

Moving to our expenses, the global restructuring we announced in mid-2025 produced meaningful cost savings in the fourth quarter.

Total operating expenses declined by 31% or $13.5 million. By category, cost of goods sold declined by 63%, reflecting 2024 one-time inventory write-offs, as well as the restructuring impact from negotiations or supply agreements. Excluding these one-time items, costs declined by 10%.

SG&A declined by 46% and represented 41% of total net sales compared to 59% of total net sales in last year's fourth quarter, reflecting the early benefits from our global restructure. R&D expenses were stable, in line with our ongoing commitments to global regulatory support and to the science underlying our global branded product.

Restructuring expense was $4.1 million, down from $9.4 million in the third quarter of 2025, bringing our total annual restructuring expense to $36.2 million. As previously announced, we expect to incur the last of these expenses in early 2026. Excluding the restructuring charge of $4.1 million total OpEx declined by 41% from last year's fourth quarter.

Our operating loss in the fourth quarter narrowed to $2.3 million from an operating loss of $16 million in last year's fourth quarter, excluding restructuring charges in both periods. Turning to the balance sheet, we generated positive cash flow from operations of $7 million in 2025, ending the year with $303 million in cash and investments, no debt, and working capital of $455 million.

I'll echo what Aaron said earlier. 2026 will be a pivotal year for Aarron. It will also be a period of transition and recalibration, defined largely by the first full year of a Park model in Europe. We are confident that our financial position will support our business activities for 2026, including the normal first quarter seasonality in the US and quarterly fluctuations in revenue from supply shipments inherent in partnership agreements.

We expect to generate positive cash flow for the full year in 2026 through cost efficient revenue generation with our US franchise and our new international business model while operating with a significantly improved OE profile, reflecting the approximately $70 million in annualized savings to be achieved by the end of Q2 2026.

Thank you again for your attention, and I now ask the operator to open the call to questions.

Certainly at this time we will be conducting a question-and-answer session.(Operator Instructions)

Michael, Leerink.

Hi, this is Michael on for Wanda Reed at Learn Partners, and thank you for taking our question. Our question is, like, could you provide more color on the volume versus price, dynamics in 4Q?

And given that like there seems to be a net pricing pressure, has a calculus on launching an offer generic changed at all, and what would the trigger look like? Thank You.

Thank you, Michael. It was a little bit hard to hear, but did you say volume versus price? Are you talking about the US?

Yes, that's correct.

Do you want to comment on.

Yeah, in Q4, our volume and price compared to Q3 remained relatively consistent. So we have seen that consistency, as mentioned when we look into 26, that's when in the first quarter we typically see that initial, the bulk of our volume decline. And from a pricing perspective, we always, have some pricing pressure as we deal with the market dynamics, related to being in the generic environment.

The volume, the volume normalizes, tends to flat, so we take the, as we've seen in Q1 each year, there's more volume pressure in Q1, but that tends to level out going into Q2 and the pricing as the year goes on should also be relatively consistent. Just again a reminder we're focused on exclusives and.

And as long as we maintain those exclusives, then it should be fairly consistent. It's a dynamic market, a number of generic competitors, and, things can happen during the year, but we're confident we're starting the year well with our exclusives in place and the strategy continues to work here in the US where we're focused on payer access, and not as much on the, sales and marketing effort as you know.

So, strategy is working, looking forward to continuing to generate, cash, profitable revenue here in the US, for 2026.

All right, thank you.

Daniel, Goldman Sachs.

Good morning, team. This is Daniel on for Paul. So we have a question on, for 2026 in the US, how confident are you able to sustain, exclusivity with your existing, exclusive formulary? Thank you.

Thanks, Daniel. So we're now five years into the introduction of a generic and at the beginning of each year, the end of each year and beginning of each year, we say how long can we maintain it and we, our team has done an exceptional job.

We've started the year maintaining our exclusives. We're confident that we can maintain them. Through the year, but we also know that, for example, in 2024, in the middle of the year, we lost a PBM but got it back in 2025. So it can be relatively dynamic, but we're starting the year in a confident position with our exclusives in place and we continue to be profitable. So I look forward to a good year. Thank you.

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

Yeah, thank you. Thank you all for your interest in Amarin, and for taking the time to listen to us today. Appreciate it. Have a good day.

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