Amarin Corporation - Earnings Call - Q2 2025

Executive Summary

• Q2 2025 delivered a clean top-line beat driven by Recordati upfront revenue: total net revenue $72.7m vs $67.5m YoY (+8%) and well above S&P consensus $53.8m*, offset by a GAAP net loss $(14.1)m (−$0.03 per Ordinary Share) due to $22.8m restructuring; non‑GAAP EPS $0.04 per Ordinary Share (or $0.87 per ADS). Results versus consensus: revenue $72.7m vs $53.8m*, EPS $0.87* vs $(0.25)* (ADS basis)*.
• Strategic pivot: exclusive long‑term licensing and supply deal with Recordati to commercialize VAZKEPA across 59 European countries; global restructuring expected to reduce OpEx by ~$70m over the next 12 months.
• U.S. remained stable operationally but under pricing pressure: U.S. net product revenue fell 17% YoY to $36.5m; market share ~43% at quarter end; a large U.S. payer returned Vascepa to exclusive status July 1, lifting share to ~50% in July (near‑term support to volumes).
• Cash and balance sheet remained strong at $298.7m, with no debt; management emphasizes path to positive free cash flow as restructuring savings phase in and European royalties ramp.
• Stock reaction catalysts: (1) size and pacing of European royalty ramp with Recordati; (2) visibility on OpEx run‑rate realization; (3) U.S. payer exclusivity durability and any decision/timing on authorized generic; (4) updates on strategic alternatives with Barclays.

What Went Well and What Went Wrong

What Went Well

• Recordati partnership accelerates Europe and supports pivot to asset‑light model; transition largely completed by end of 2025; expected ~$70m OpEx savings next 12 months. Quote: “significant steps to increase value for shareholders”.
• Revenue diversification improved: Europe revenue +85% YoY ($6.6m) and RoW revenue up significantly ($3.5m vs $0.2m), while licensing and royalties rose 31% to $26.1m on the Recordati upfront and stronger partner sales.
• U.S. commercial execution resilient: retained all major exclusive accounts through Q2; market share stable at ~43%, with July share ~50% after a national payer returned to exclusivity (supports near‑term volume). CFO: “market share increase to approximately 50% in July… likely due to this change”.

What Went Wrong

• U.S. net product revenue fell 17% YoY to $36.5m on ongoing generic pricing pressure; management still expects YoY U.S. revenue declines to continue.
• GAAP profitability impacted by restructuring: $22.8m charges tied to reorganization drove GAAP net loss $(14.1)m despite revenue beat (non‑GAAP profitability positive).
• Operating loss widened YoY: Operating loss $(16.0)m vs $(0.5)m YoY despite gross margin expansion to 52% (higher OpEx with restructuring; underlying OpEx ex‑restructuring flat YoY).

Transcript

Operator (participant)

Morning, and welcome to Amarin Corporation's conference call to discuss its second quarter 2025 financial results. I would now like to turn the conference over to Mr. Mark Marmur, Vice President, Corporate Communications and Investor Relations at Amarin. Sir, the floor is yours.

Mark Marmur (VP of Corporate Communications and VP of Investor Relations)

Good morning, everyone, and thank you for joining us. Please be aware that this conference call will contain forward-looking statements that are intended to be covered within 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 31st 2024, and the quarterly report on Form 10-Q for the quarter ended June 30th 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. An archive of this call will be posted on Amarin's website in the investor relations section. Turning to today's agenda, Aaron Berg, Amarin's President and Chief Executive Officer, will provide an update on the state of our business and operational progress, and Peter Fishman, Amarin's Chief Financial Officer, will review our second quarter 2025 financial results. Following these prepared comments, there will be a question and answer session.

With that, I'll turn the call over to Aaron Berg, President and Chief Executive Officer of Amarin. Aaron.

Aaron Berg (President and CEO)

Thank you, Mark. Good morning, everyone, and thank you for joining us today. Q2 2025 was a pivotal quarter for Amarin, marked by decisive strategic actions and steady operational progress. Two significant strategic actions marked a pivotal shift for the company. First, we entered into a long-term licensing and supply agreement with Recordati, intended to accelerate commercialization for Vascepa across Europe. Partnering with Recordati will build on our early efforts to drive the commercialization of Vascepa in this important growth market. Our core franchise will now be in the hands of a partner with significant cardiovascular experience, established infrastructure, and the resources to build on the progress our team has achieved in the region, in particular related to market access, scientific support, and initial commercial launch results.

We expect that through this partnership, Vascepa patient penetration in Europe will increase, resulting in benefits for the company and shareholders through the structured royalty stream, as well as the sales milestones under the licensing agreement. In conjunction with the European partnership, we further right-sized our global organization, which will result in anticipated operating expense savings of approximately $70 million over the next 12 months. As we continue to operate in an increasingly efficient manner, we'll focus our resources on contributing to the success of our global partners as they drive growth. Our financial results this quarter reflect the steady operational progress we are making with our business. We delivered solid product sales growth in Europe and other key markets in the rest of the world, both year-over-year and sequentially, while managing our expenses tightly, as we've consistently done over recent years.

These significant steps better position us to maximize the global potential for Vascepa and drive increased shareholder value, powered by the following key foundational strengths. Number one, Vascepa is a proven treatment to reduce cardiovascular risk, supported by robust clinical evidence, including the landmark REDUCE-IT study, which demonstrated a 25% reduction in major adverse cardiovascular events when icosapent ethyl is added to statin therapy. This science is matched with ever-growing support from key opinion leaders, evidenced by endorsement from more than 50 medical societies worldwide due to its proven efficacy and safety profile and the increasing recognition that Vascepa is a complement to current therapies available today for physicians addressing the cardiovascular risk in their patients. This recognition by the global scientific community of the significance of the REDUCE-IT data has helped deliver regulatory approvals in 50 countries globally as an effective treatment for cardiovascular risk reduction.

Number two, we have a global business with multiple efficient revenue streams across the U.S., as well as the partner markets of Europe and the rest of the world. Number three, we have a strong financial foundation built on a significantly reduced and substantially more efficient operating model, combined with a sound balance sheet of nearly $300 million in cash, zero debt, and on-hand inventory levels sufficient to meet global demand, all of which put us on an accelerated path to positive cash flow. Now, regarding operational progress and our second quarter results, we continue to make meaningful progress across our global operations, with our enhanced partnering efforts playing a central role in driving growth and expanding access to Vascepa worldwide. While the U.S.

remains foundational to our business, I'd like to focus on the progress we're seeing across Europe and our rest of the world markets, where through our partnerships, we continue to expand access to Vascepa for patients in need. To start, I'll talk about Europe. As a result of the tremendous efforts of our team, access and demand for Vascepa have been building in the region. During the quarter, in-market demand increased 17% from Q1 2025, a healthy indicator of growing momentum on a sequential basis. Through the first six months of this year, in-market demand grew 132% versus the first six months of 2024, largely from Spain and the U.K., which continue to drive the majority of uptake and revenue in Europe. In Italy, a key market, our team has been focused on expanding regional access, a critical step to prepare the market for uptake upon launch.

We've now secured reimbursement in most local regions, representing over 91% of the total eligible patients, particularly in high-density areas, a positive sign of market interest. As mentioned, our recent partnership with Recordati strengthens our ability to capitalize on this early progress with Vascepa and leverages Recordati's cardiovascular expertise and commercial scale to accelerate utilization in Europe. We are focused on rapidly transitioning the business to Recordati, which we expect to be largely completed by the end of 2025. Both teams are working exceptionally well together, and we're impressed with how passionate and knowledgeable the Recordati team is about Vascepa and its benefits for patients. Now, turning to the rest of the world markets, our partners are focused on driving patient uptake through the tremendous value and potential for Vascepa in their respective markets and continue to make progress in commercialization or regulatory process locally.

In China, our partner, Eddingpharm, is pursuing their commercialization efforts focused on post-PCI patients in top-tier private hospitals through the self-pay market. This strategy is delivering strong in-market demand growth, with 68% growth versus the first quarter of 2025, leading to strong revenue and profitability and is anticipated to meet current internal growth targets. With an estimated 330 million cardiovascular patients and one of the highest CVD mortality rates globally, China continues to represent a significant long-term opportunity for Amarin. In Australia, our partner, CSL Seqirus, is executing a thoughtful launch strategy focused on recent ACS patients. Since January, CSL has seen steady in-market demand growth, with 75% growth in the first quarter of 2025 versus the fourth quarter of 2024, the most current period where data is available. This is supported by a strong scientific foundation and a target population of approximately AUD 1.3 million with established cardiovascular disease.

In Canada, our partner, HLS Therapeutics, continues to deliver volume growth, with 31% month-over-month growth as of May. HLS also recently secured a product listing agreement with Nova Scotia Pharmacare, effective July first 2025. We expect this will expand public reimbursement and access to Vascepa across the Canadian market. Our partner, Biologix, reported strong volume growth across the Middle East and North Africa markets, with 62% growth versus the first quarter of 2025, driven primarily by Saudi Arabia. In Southeast Asia, our partner, Lotus, an established company with significant in-region capabilities, is advancing regulatory and pricing and reimbursement processes across Southeast Asia. Recently, South Korea granted regulatory approval for Vascepa, taking us to 50 markets globally where Vascepa has been approved for cardiovascular risk reduction. The product is now progressing through the pricing and reimbursement phase in South Korea, which is expected to take approximately a year.

The success of our partners in Europe and the rest of the world is critical to our global strategy of making Vascepa available to the millions of patients in need of cardiovascular risk reduction, including the nearly 8 million patients in Europe with established cardiovascular disease. All of our partners are demonstrating great capabilities and focus to support the continued expansion of Vascepa. Lastly, a few comments about the U.S. business, still the core contributor of revenue for the company. We've sustained the Vascepa franchise for more than four years after the introduction of the first generic product in the U.S. Thanks to the dedication of our team, we retained all major exclusive accounts through Q2 2025, and our market share remained stable at 43% at quarter end, delivering meaningful revenue and profit contributions that continue to form the foundation of U.S. product sales and margin.

As we noted previously and have experienced in prior years, we typically observe prescription volume declines in the first quarter, followed by volume growth in the second quarter. This was the case for Q2 2025, where we saw volumes increase by 7% sequentially. Looking ahead, while we expect continued year-over-year revenue declines, we remain focused on maximizing value from the U.S. market through smart, efficient, and targeted commercial execution. Pricing pressure remains volatile, and it's still too early to make predictions for 2026. That said, we are prepared to launch our authorized generic when optimal as part of our ongoing product lifecycle management approach. In summary, our U.S. business remains a significant cash generator, almost five years post-generic entry.

The European business and rest of the world partnerships continue to build momentum, and we're encouraged by the collaborative efforts to ensure the success of all our partners with the knowledge and support they need to maximize the brand's global potential. To conclude, let me end with the following. Amarin today is in a far different and healthier position. We've executed a plan to partner out a key growth market while implementing an even leaner global operating footprint. With these actions, I'm confident that we're well positioned to deliver value for shareholders. In addition, as mentioned previously, we're actively working with Barclays as our exclusive financial advisor to evaluate further potential strategic opportunities to capitalize on the inherent value of Amarin and increase shareholder value.

There's no defined timeline for this initiative, as we'll take the necessary time to carefully evaluate the best options, and we'll keep you informed should any material developments arise. Overall, this phase of the company's evolution is focused on capitalizing on our strengths, financially, operationally, strategically, and we're poised to efficiently and urgently drive the pace and scope of patient uptake across the key growth markets in Europe and the rest of the world, all driven by an unwavering commitment to our core mission to maximize the global potential of the Vascepa franchise. With that, I'll turn it over to Peter Fishman, our Chief Financial Officer, to walk through the financial results for the second quarter. Peter.

Peter Fishman (CFO)

Thank you, Aaron. Turning to the financial results, Q2 2025 total net revenue was $72.7 million, an increase of $5.3 million or 8% versus the prior year period, primarily reflecting the impact of the Recordati upfront payment. Q2 2025 net product revenue was $46.6 million, a 2% decrease primarily driven by lower net selling price in the U.S., which was almost entirely offset by growth in Europe and the rest of the world markets. An important indication of the potential impact these ex-U.S. markets can have on our overall performance as we continue to manage the generic environment in the U.S. As for the U.S. business, Q2 2025 net product revenue was $36.5 million, a decline of 17%, reflecting the continued pricing pressure from generics. Volumes in the quarter rebounded compared to Q1, as expected, following normal core seasonality, and the U.S.

team continues to deliver material contributions from this business despite ongoing and persistent headwinds. In addition, a large national payer moved Vascepa back to exclusive status as of July first. We have seen our market share increase to approximately 50% in July, which we believe is likely due to this change. This reflects our continued commitment to the lead-on price to maintain Vascepa's market leadership. Because of pricing dynamics in the market, we do not anticipate that this change will have a material impact on overall profitability. In Europe, Q2 2025 product revenue reached $6.6 million, almost double the prior year period, and continuing the trend of quarterly in-market demand growth across all launch markets. Consistent with recent quarters, Spain and the UK continue to be the largest contributors. As commercialization moves to Recordati, we should expect patient access to Vascepa throughout Europe to expand.

We look forward to reporting on this evolving opportunity over subsequent quarters. In the rest of the world markets, Q2 2025 product revenue was $3.5 million, significantly higher than the prior year period and driven by partner purchases, indicating that market access for our group of partners across this diverse segment is expanding. As a reminder, rest of the world revenue will remain variable quarter to quarter based on launch timing, in-market demand, and the structure of individual partnership agreements. We remain confident that over time, growth will build across our partner markets. Q2 2025 licensing and royalty revenue was $26.1 million, up 31% from the prior year period, clearly reflecting the impact of the upfront payment from Recordati, as well as in-market demand driven by our partners.

Overall, the state of our revenue generation in the quarter indicates momentum in the growth segments of our business, while continuing to realize profitable revenue as we manage the mature U.S. business. Turning to expenses, let me begin with reminding everyone that in parallel with the Recordati licensing agreement, we initiated a global restructuring where we recognize expenses during Q2 and will continue to incur expenses throughout the rest of the year. This action will result in an estimated $70 million in operating expense savings over the next 12 months, a significant change in our operational footprint and cost structure needed to support the brand globally and run a public company. Q2 2025 SG&A and R&D were $38.7 million and $4.9 million, consistent with the prior year period. Our operating expenses continue to reflect our disciplined expense management and do not yet reflect savings from the recently announced restructure.

Q2 2025 cost of goods sold was $22.4 million, a decrease of $2.3 million or 9% over the prior year period. Now, turning to the balance sheet, we ended the quarter with $298.7 million in cash and investments and no debt. We continue to focus on cash preservation and growth for the future, and the strategic actions we've taken will result in significant progress in these efforts. Importantly, our on-hand inventory is sufficient to meet global demand, and we have a robust global supply chain that will enable us to continue to support and supply our partners as market demand grows throughout the world. In summary, our Q2 2025 results reflect the resiliency in our U.S. business, as well as initial indications of growing steady momentum in the still vastly underserved global market outside the U.S.

Operationally, we are sufficiently capitalized to finance our operations as we continue to progress on an accelerated path to positive cash flows. With that, I'll turn the call back over to Aaron for closing remarks. Aaron.

Aaron Berg (President and CEO)

Thanks, Pet. In closing, let me finish with the following. We've taken steps to better position the company to realize its mission. We monetized the European market after putting in place a substantial base to build off of. Vascepa is now in the hands of a proven partner in Europe. By putting in place yet another contributor to our royalty-based revenue foundation, combined with the other partners across the globe, coupled with a significant restructuring and further complemented by our continued maintenance of the mature U.S. market, all of this combines to putting us on a path to eventual growth and positive free cash flow. The timing of realizing these value-creating elements is not yet clear. Rather, at a minimum, we've taken the right steps to put in place a means by which they could be realized, and we must continue to execute globally.

In short, this is a pivotal time for the company, and we wouldn't be in this position without the dedication of our employees and partners around the world. Thank you. Your dedication continues to make a meaningful difference in the lives of patients every day. With that, we'll get started with Q&A. Operator.

Operator (participant)

Thank you. At this time, we'll be conducting our Q&A session. If you would like to ask a question, please press *1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue, and you may press *2 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 * keys. One moment, please, while we poll for questions. Thank you. Our first question is coming from Paul Choi with Goldman Sachs. Your line is live.

Paul Choi (Biotechnology Analyst)

Hi, thank you. Good morning, and thank you for taking our questions. My first question is, can you maybe just update us on how you're thinking about your formulary negotiations in the U.S. and potential changes for 2026? Anything that you would call out that we should be mindful of as we sort of think about how your U.S. trajectory might look like and the role of potential authorized generic and how that figures in your 2026 strategy. My second question is, now with the Recordati partnership signed, can you maybe just share with us what sort of metrics you're going to provide to the street so we can just sort of monitor progress and how you plan to benchmark that? Thank you very much for taking our questions.

Aaron Berg (President and CEO)

Thanks, Paul. Appreciate the question. For the first question around the U.S. business, we've continued to maintain our exclusives in 2025. We anticipate that we'll maintain those exclusives through the rest of 2025. We'll have further clarity on 2026 as we get toward the end of the year. In terms of the AG, we've been prepared, and we've stated this a number of times, we've been prepared to launch an AG when the time is optimal. That time is not yet because we've been able to compete very well with the branded products, maintain our volume, maintain the volume profitably in the U.S. As you know, if you launch an AG, it will further erode the brand. Right now, it's in our best interest to continue with the brand. We'll be ready to launch the AG, and that's based on a number of dynamics in the market.

In the IPE market, which is increasingly genericized, more pricing pressure, more competition. We'll see how that progresses in the future. Here we are, almost five years since the first generic was introduced into the market. Now there are multiple generics, and we've maintained over a 40% share in the IPE category. We'll continue to execute on the U.S. business with this strategy, which has worked well. Regarding Recordati, overall, we're in the transition phase right now. The teams are working exceptionally well together. There are a lot of moving parts, essentially. Our team has been doing a lot of work. There's a lot of activity, a lot of progress made in individual countries that we're trying to smoothly and quickly pass the baton to Recordati. They're excited to pick it up. They're going to make the product a priority.

As we stated in the script, Recordati will have full control of commercialization by the end of the year. We'll have further clarity on in-market demand as time goes on. As you know, with launches, which some of this is, particularly in Italy, it takes some time for commercialization efforts to make an impact. Once we see that impact, we'll certainly be commenting on in-market demand in Europe, and we'll certainly be providing the financial results as we have on a quarterly basis. Thank you. Hope that helped.

Operator (participant)

Thank you. Our next question is coming from Jessica Fye with JPMorgan. Your line is live.

Jessica Fye (Managing Director and Equity Research Analyst)

Hey, guys. Good morning. Thanks for taking my questions. I'm curious with the rebound in script growth quarter over quarter, just kind of how you're thinking about U.S. volume for the back half of the year, as well as kind of your latest expectations on the near-term trajectory for net price in the U.S.? Separately, you mentioned kind of that you're reviewing other strategic opportunities. What's on the menu there? I'm not committing you to anything, but just kind of like what are some of the possibilities that you might entertain? Lastly, just a little help with modeling. Can you just help us think about kind of like the timeframe over which we should expect that $70 million of annualized cost savings to be realized with a little more nuance, you know, kind of quarter by quarter? Thank you.

Aaron Berg (President and CEO)

Sure. Hi, Jess. Thanks for joining us and thanks for the questions. First of all, regarding the volume in the U.S. at the second half of the year, not only do we maintain the exclusive that we had in the first half of the year, but a major payer put Vascepa back in the exclusive position starting July first. That is why you saw, I assume you're commenting on that rebound in our share and in our volume. There has been typical Q2 growth, and we had a payer add Vascepa to the exclusive position in Q3. We expect to maintain that volume going into the second half of the year. As we stated, we'll have further clarity on 2026 as we get to the end of the year. Pete, do you want to comment on net price?

Peter Fishman (CFO)

Sure. Thanks, Aaron. Thanks for the question. As far as net price, we would expect it to remain fairly comparable to what we've seen in Q2, as long as we don't lose any of the exclusives for the rest of the year. As Aaron had mentioned, we don't anticipate losing them. That would be where we would see an impact on net selling price. Otherwise, the way you can look at it is relatively consistent to this past quarter. Also, I'll go through from the cost savings and the $70 million. The way we would look at it is you could really kind of straightline that over the next four quarters.

In this next quarter, as we're going through the transition period, you may not see the similar, you know, there might be a little bit less of that savings, but you'd see that in the restructuring bucket in terms of that cost amount. From OpEx excluding restructuring, you'll begin to see that on a straight line basis over the next four quarters.

Aaron Berg (President and CEO)

Regarding the question around the strategic opportunities, right now, our primary focus is on driving Vascepa globally, helping all of our partners, in particular, of course, a major focus on Europe right now to help Recordati get up to speed and take command of the commercialization efforts as quickly as possible. We are looking forward to them making an impact and doing what we can to help them make an impact through the rest of the year and certainly kicking off 2026. With regard to the strategic opportunities, we are in a position of strength. We have got a solid operational and financial foundation. We have just made it much stronger as a result of this partnership and the restructuring and the resulting cost savings. Nothing is off the table in terms of those options. We will be very judicious in looking at what those opportunities are.

They could take any shape or form. There is no assurance or timeline for the transaction and no assurance that a transaction will occur. Overall, we do not intend to comment further or provide updates with respect to strategic alternatives other than what is required of us. We look forward to approaching this effort with enormous confidence from a position of strength and a focus on shareholder value.

Jessica Fye (Managing Director and Equity Research Analyst)

Great. Thank you.

Mark Marmur (VP of Corporate Communications and VP of Investor Relations)

Thank you.

Operator (participant)

Thank you. Our next question is coming from Roanna Ruiz with Leerink. Your line is live.

Mazi Alimohamed (Biotech Equity Research)

Thank you, everyone. This is Mazi Alimohamed on for Roanna Ruiz. One, it's a two-parter, but one from us. With strong IP protection in Europe and Recordati's established CV infrastructure, what are your realistic expectations for European market penetration over the next three to five years? In kind of a second parter to this, how does Recordati's presence in both primary care and specialty cardiology position Vascepa differently than your previous direct approach? Thank you.

Aaron Berg (President and CEO)

Thanks, Maisie. First of all, as we commented before, it's very early to be making projections on three to five years of what we expect from a forecasting perspective out of our partnership in Europe. We know we're at the early stages in a number of countries. We know that our team has done a phenomenal job with what we've had. It's been a limited effort, all hands on deck with who we've had. We're a smaller organization, as we've commented on before. We were trying to build it from scratch. We had no existing infrastructure. We had to build that, the relationships, establish the brand, all of that we had to do. Recordati, on the other hand, is a well-established cardiovascular European organization. We're thrilled to see their passion and how quickly they want to take command and be driving growth.

We're very optimistic about the ability to grow and the ability to accelerate the growth. Part of that is part two of your question. Our efforts have been very focused on the highest risk patients and focused on specialists. We've been operating more as a specialty organization in Europe, very limited in terms of our infrastructure, in terms of our spend, in terms of our reach to providers. Recordati sees the opportunity because of the label and the reimbursement we have, which is broad. They have the opportunity to go to the physicians that treat these patients, which include primary care as well. Given that they have an already established primary care organization on top of a cardiology center organization, that will make this certainly much better, make the impact, we think, much greater than we would have been able to do. We look forward to that growth.

When the time is right, once they make an impact, as we said earlier, we'll be reporting on what those results are. Thank you.

Mazi Alimohamed (Biotech Equity Research)

Great. Thank you so much.

Operator (participant)

Thank you. As we have no further questions on the lines at this time, I would like to hand the call back over to Mr. Berg for any closing remarks.

Aaron Berg (President and CEO)

Thank you very much. I appreciate it. First of all, we hope everyone found the update helpful. We appreciate you taking the time out of your busy days to join us today and enjoy the rest of the day. Thank you.

Operator (participant)

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.