Earnings Labs

Amarin Corporation plc (AMRN)

Q1 2025 Earnings Call· Wed, May 7, 2025

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Transcript

Operator

Operator

Welcome to Amarin Corporation's Conference Call to discuss its First Quarter 2025 Business Update and Financial Results. I would like to turn the conference call over to Mark Marmur, Vice President, Corporate Communications and Investor Relations at Amarin.

Mark Marmur

Management

Good morning, everyone and thank you for joining us. Turning to Slide 2 in our forward-looking statements. Please be aware that this conference call will contain forward-looking statements that are intended to be covered under 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 31, 2024 and the quarterly report on Form 10-Q for the quarter ended March 31, 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 Slide 3 in today's agenda, Aaron Berg, Amarin's president and Chief Executive Officer, will provide an update on the state of our business. Pete Fishman, Amarin's Chief Financial Officer, will review our first quarter 2025 financial results and at the end of the presentation, Aaron will provide closing remarks followed by a question-and-answer session. I will now turn the call over to Aaron Berg, President and Chief Executive Officer of Amarin. Aaron?

Aaron Berg

Management

Thank you, Mark. Good morning, everyone and thanks for joining us today. I want to start by sharing some of the key accomplishments that point to the foundational work that's been done over the last two years, setting the stage for meaningful future growth for the company. In the U.S. we continued our strategy of focusing on managed care access to maximize branded revenue in an increasingly genericized market. In Europe our revamped leadership team implemented a new targeted strategy focused on a very high-risk patient group, those with established cardiovascular disease or ECVD. This population, eligible for VASCEPA is estimated to be more than six million patients and secondary prevention in Western Europe alone. This strategy has been pulled through in both pricing and reimbursement efforts as well as the overall brand strategy. We also extended our European IP out to 2039, providing a much longer runway to maximize the value of VASCEPA. We expanded our rest of the world presence by entering into additional regional partnerships including in Southeast Asia, MENA and Australia. Our R&D and Medical affairs teams continue their efforts on advancing medical community understanding around the science and potential of VASCEPA to impact CV risk globally. And we also took aggressive, meaningful steps to reduce operating costs, manage our cash and improve our supply position. With these strategic and operational actions, we strengthened the foundation of the company, improving the potential for future growth and while still early on, we are seeing tangible results. Since the first quarter of 2023, we've significantly increased the number of countries globally where VASCEPA is reimbursed and launched from seven in 2023 to 21 today. While many of these countries remain in the early stages of commercialization, the steps we've taken widen and deepen the footprint for broader patient…

Peter Fishman

Management

Thank you, Aaron, good morning, everyone. Turning to slide 7. In the first quarter of 2025 we reported total net revenue of $42 million, including net product revenue of $41 million and $1 million of licensing and royalty revenue compared to total net revenue of $56.5 million in the first quarter of 2024. U.S. product revenue was $35.7 million compared to $48.1 million in the first quarter of 2024. This decline was driven by lower net selling price due to generic competition and a decrease in volume. As a reminder, we typically see the bulk of the full year U.S. declines in volume and price in the first quarter of the year. Despite the revenue decline, the U.S. business continues to deliver significant cash with a remarkable track record for a branded product this far out from the introduction of generics. European Product revenue was $5.4 million, a $3.5 million increase over the prior year period driven primarily by continued in market demand growth in Spain, the U.K. and Central Eastern European markets. Product revenue also reflects revenue from our partnerships throughout the rest of the world where we are in the early stages of commercialization in numerous regions. While in the first quarter of 2025 we recorded minimal net product revenue from our partners compared to $5.2 million during the first quarter of 2024, there continues to be in market demand growth sequentially quarter-over-quarter in all geographies where our partners have launched. It is important to note that product revenues in the current year period were impacted by launch supply order timing from our partners in the fourth quarter of 2024 to meet initial and anticipated 2025 in market demand based on the growth trends seen in 2024. As Aaron mentioned earlier, many of our partners are now shifting…

Aaron Berg

Management

Thanks Pete. Turning to slide 10 as you've heard today, the company is in a very solid position as we begin 2025. We've made progress across all of our priorities by proactively modifying our strategy to drive the future opportunity for growth. We know there's more work to do to fully capitalize on the untapped global potential for VASCEPA and we'll continue to consider all opportunities available to us to ensure we unlock this value. This is what continues to drive our priorities and guide the actions we continue to take to maximize shareholder value. I want to reiterate a key point that continues to bring us back to the global value potential for VASCEPA. Simply stated, we have in our hands a product that can significantly help address the scourge that is cardiovascular disease today. Still the number one killer globally. Today, VASCEPA is available to clinicians and has been proven to be a valuable tool in the global fight against cardiovascular disease. We remain committed to accelerating the pace and expanding the scope of access to this tremendous drug. And in conjunction with widely used lipid lowering agents focused on LDL lowering, there continues to be growing evidence that VASCEPA can directly address cardiovascular risk and potentially reduce the incidence of cardiovascular events worldwide. That's the opportunity and clear mandate before us. Finally, I'd like to take a moment to thank the entire Amarin team and our partners around the world for their continued commitment and dedication. Your efforts are deeply appreciated and know that you're impacting the lives of at-risk patients around the world every day. Thank you. With that operator, let's begin the Q&A portion of the call.

Operator

Operator

Certainly, at this time we will be conducting a question-and-answer session. [Operator Instructions] Your first question for today is from Jessica Fye with JP Morgan.

Unknown Analyst

Analyst

Hello, this is Adam on for Jess. Thank you for taking our question. 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? Thank you.

Aaron Berg

Management

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.

Unknown Analyst

Analyst

Thank you.

Operator

Operator

Your next question for today is from Roanna Ruiz with Leerink.

Unknown Analyst

Analyst

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?

Aaron Berg

Management

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

Analyst

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

Management

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.

Unknown Analyst

Analyst

Thank you. Thank you for the thoughtful response.

Operator

Operator

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

Aaron Berg

Management

Thank you, operator. Thank you. Thanks everyone for taking the time to join us this morning. We appreciate the interest and continued interest in the company. Again, as we said, we're looking forward to where we go moving ahead. We've made the right changes and look forward to growth as we go forward and look forward to giving you further updates. But thanks again for your time. Appreciate it.

Operator

Operator

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