Amarin Corp. Plc Q1 FY2025 earnings call

Management Statement and Operational Highlights

• Strategic Focus: In U.S., focused on managed care access to maximize branded revenue. In Europe, revamped strategy for high-risk ECVD patients, extended European IP to 2039, and expanded rest of world partnerships in regions like Southeast Asia, MENA, and Australia.
• Operational Progress: Increased number of countries where VASCEPA is reimbursed and launched from 7 in 2023 to 21 in 2025. Reduced operating costs, managed cash, and improved supply position. R&D and medical affairs teams advanced science and educational initiatives globally.
• Market Access: Secured reimbursement in new markets, advanced pricing and reimbursement efforts, and made progress in Italy, Austria, and other European countries for broader access.

Segment Performance

• Europe: VASCEPA revenues in Q1 2025 were $5.4 million, representing 16% sequential quarterly growth. In Italy, secured access in 14 of 21 local regions, covering over 85% of the eligible market. Secured reimbursement in Austria and launched commercially in April. Active engagement in Norway and Ireland for reimbursement decisions later in 2025.
• U.S.: VASCEPA revenue was $35.7 million in Q1 2025, down from $48.1 million in Q1 2024 due to generic competition and volume decline. Retained major exclusive accounts from Q4 2024 through Q1 2025, focusing on generating revenue and maximizing U.S. branded business profitability.
• Rest of the World: Rest of world product revenue was less than $0.1 million in Q1 2025, but with in-market demand growing in launched countries. Early stages of commercialization in various regions, with partners driving regulatory and commercial progress despite choppy quarterly revenues due to early launch phase.

Guidance

• Europe: Anticipated growth in Europe with ongoing efforts in market access, pricing, and reimbursement. Expectations of a more efficient commercial launch in Italy later in 2025.
• U.S.: Continued focus on generating cash and maximizing profitability of the U.S. branded business, with expected volume fluctuations due to seasonality but confidence in extracting value through efficient execution.
• Rest of the World: Expect growth despite choppy quarterly revenues due to early launch phases, with optimism based on in-market demand, strong partners, and unmet medical needs.

Risks

• Forward-Looking Statements: Actual results may differ from forward-looking statements due to various factors. Refer to Risk Factors section in SEC filings for potential material differences.

Question and Answer

Q: Hello, this is Adam on for Jess. I just wanted to ask rest of world revenues of less than $0.1 million fell significantly year-over-year and sequentially. I just wanted to ask what drove this decline and should we expect it to bounce back up going forward?

A: Thanks for the question. So, rest of the world, first of all, we're very encouraged by the position we're in in spite of the fact that there was the revenues for Q1 were limited. As we said in the past, the way that these individual countries report will make the quarterly revenue variable and it will be choppy as we get started. They're just launching. We're very early. They're operating off a small base and the way shipments go, in some quarters they'll be there and in some quarters they won't. But overall, we expect growth. We're encouraged by the in-market demand we're seeing in the countries where we've launched. And it's very recent. Right. You heard in the script how early we are in so many of these countries in the last 12 months, just launching, getting off the ground. We learned from the experience of the U.S. that it's a brand that takes some time to build a foundation and then it starts to ramp-up. But we have good partners. We know that there's an unmet need, the product's being received well, scientific foundations being built, pricing reimbursements being accessed. And we're very encouraged and optimistic about where we'll go going forward. But it still may be choppy quarter-to-quarter.

Q: Hi, this is Mazy on for Roanna. Just one from us, but really just more of a science question. But given the established data now on REDUCE-IT and cardiovascular outcomes, what additional real-world evidence or clinical development plans do you have to potentially expand labeling or strengthen differentiation against generics? Particularly as we continue to see the evolution in the lipid management landscape with all the newer emerging therapies?

A: Thanks, Mazy. Appreciate the question. So, I'll start off and then we have Dr. Steve Ketchum here with us and Steve can add on. So I'll try and dissect the question a little bit. We're always looking and have been very active in generating new data to differentiate the product. Now I'll separate generics for a minute because that's a little bit of a different animal, but certainly to show the value of IPE and the uniqueness of IPE. And given the number of publications that I cited in the script and didn't even talk about what we've generated over the last decade, really, which is hundreds and hundreds of publications to show the uniqueness. And that's one thing that we've done exceptionally well. And certainly, since reduce it, the team has done a remarkable job mining that data to show the differentiation. Some of the new therapies it's exciting to hear talk of Lp(a) or possible rebirth of CETP inhibition and those products, and look forward to where those products take us. I think what's encouraging for us is one, it shows there's still residual risk after LDL lowering alone, even though they're focused on LDL lowering with CETP inhibitors, that even when LDL is treated, there's still significant cardiovascular events. And that's even when patients have LDLs that are low. And that's where VASCEPA comes in. And we generate a lot of data to show certainly REDUCE-IT showed that because it was on top of standard of care, VASCEPA is available today with significant cardiovascular risk reduction. So maybe those other products come out and maybe they're good for a subsegment of patients individually. But this is a product that could certainly make a difference today. And we certainly hope that the scientific community focuses on that. And even though in the U.S. we're challenged because of the generic market and our investment in medical education has been limited, the rest of the world and Europe, especially Europe, with patent protection to 2039, we've got a long runway and we intend to be very -- continue to be very aggressive generating new data to show that this product is available today and is unique and can make a difference in residual risk beyond standard of care. And that will be whether these new products come out or not. And those products could be years away. But today, the scientific community and practitioners and patients, everybody can benefit from VASCEPA today. And that's one thing that we're certainly optimistic about. Steve, I don't know if you want to talk about some of the work that you've done in generating new data. Maybe some of the things coming up, some of the data we presented at ACC that shows the uniqueness as well. Steven Ketchum: Yeah, absolutely. So of course, you know, REDUCE-IT is the focal point of our development program and we continue to continues to be a rich data source and as Aaron mentioned, we've focused over the past period of time on, highlighting the strength of the data irrespective of baseline LDL-C, irrespective of baseline Lp(a). As Aaron mentioned, we do see, that we have a complementary therapy that's, got very robust data. We also continue to have a strong presence at, all of the major international medical congresses. Recently at ACC as Aaron mentioned, we continue to support data from external collaborators looking into mechanisms of action of EPA. And this includes anti-inflammatory effects on various pathways, effects on protein expression and we look forward to continuing to have a strong presence at future congresses this year. Aaron Berg: Maybe that's just to build on it. The data that's been generated has led to over 50 guideline recommendations globally and that's because of the scientific foundation and the uniqueness of the product. So today there can be a difference made in cardiovascular risk reduction and that can be done with VASCEPA and VAZKEPA and other countries and hopefully that's recognized increasingly given that we're so early in so many countries launching, we think we're poised for growth. We're confident that we've made the right changes, have the right strategy, seen the effects of that, have good partners we're looking forward to, we're very, very bullish on where we'll go going forward.