Q1 2025 Amarin Corp PLC Earnings Call
They are the Chicago'd content creators, and many YouTubers and Youtubers who have made various content for a long time. Now, the social media is stagnating much more than ever before. Those who are visible have a very touchy and are more focused on social media than they ever are on media accounts. Willne isn't enough for things like that. For opportunity and possibilities,
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Speaker Change: Good morning, everyone and thank you for joining us.
Turning to slide two in our forward looking statements.
Speaker Change: Please be aware that this conference call contains 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.
Speaker Change: 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.
Speaker 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 maturity.
Speaker Change: 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 2000.
Speaker Change: 25%, which have been filed with the SEC and are available through the Investor Relations section of our website at Www Dot dot.
Speaker Change: Dot com, we encourage everyone to read these documents.
Speaker Change: An archive of this call will be posted on <unk> website in the Investor Relations section.
Speaker Change: Turning to slide three on today's agenda.
Speaker Change: Eric Burke, <unk>, President and Chief Executive Officer, who will provide an update on the state of our business P. Fishman Amyris 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.
Speaker Change: Turn the call over to Aaron Berg, President and Chief Executive Officer, Robert Aaron.
Speaker Change: Thank you Mark good morning, everyone and thanks for joining us today.
Speaker Change: I want to start by sharing some of the key accomplishments point to the foundational work that's been done over the last two years setting the stage for meaningful future growth for the company.
Speaker Change: In the U S. We continued our strategy of focusing on managed care access to maximize branded revenue and an increasingly genericize market.
Speaker Change: In Europe, our revamped leadership team implemented a new targeted strategy focused on a very high risk patient groups, those with established cardiovascular disease or CBD.
Speaker Change: This population eligible for this study is estimated to be more than 6 million patients in secondary prevention in Western Europe alone.
Speaker Change: This strategy has been pulled through in both pricing and reimbursement efforts as well as the overall brand strategy.
Speaker Change: We also extended our European IP up 2039, providing a much longer runway to maximize the value of the CFO.
Speaker Change: We expanded our rest of the world presence by entering into additional regional partnerships, including in Southeast Asia, Mena and Australia.
Speaker Change: R&D and medical affairs teams.
Speaker Change: Continue their efforts on advancing medical community understanding around the science and potential of the cyclo impact CV risk globally.
Speaker Change: And we also took aggressive meaningful steps to reduce operating costs manage our cash and improve our supply position.
Speaker Change: 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.
Speaker Change: Since the first quarter of 2023, we've significantly increased the number of countries globally, where vascepa is reimbursed in loss from 7% in 2023 to 21 today.
Speaker Change: While many of these countries remains in the early stages of commercialization discussed we've taken widen and deepen the footprint for broader patient impact and further diversify sources of revenue generation.
Speaker Change: We've stabilized vascepa as a profitable enterprise in the U S and have maintained our leading market share.
Speaker Change: The skipper as accelerating revenue growth, albeit off a small base across European markets with patent protection through 2039.
Speaker Change: While encouraging we know theres tremendous untapped opportunity in Europe and room for significant growth.
Speaker Change: We've achieved regulatory and early commercial success through our rest of the world partnerships.
Speaker Change: Vascepa is now commercialized in nine rest of the world markets to date through these partnerships.
Speaker Change: Our R&D and medical affairs teams have continued to advance the science behind Vascepa with nearly 100 abstracts and publications more than a 150 educational initiatives since 2023 across Europe, and a strong presence at major global medical Congresses.
Speaker Change: And we've efficiently manage our cash over 10, six consecutive quarters, while maintaining a debt free balance sheet.
Speaker Change: While we are proud of this progress we know we're just scratching the surface vascepa as full potential in many markets globally, and we have much more work to do in pursuit of opportunities to unlock the value of the products and the company as a whole.
Speaker Change: We're moving with purpose determined to advance patient treatment and reduced cardiovascular risk globally, while delivering value to shareholders and we will continue to take any steps to assure we're on the right path to realizing the full potential in the near term.
Speaker Change: This is very much top of mind for our board and management team that has been the guiding force behind the transformation strategic operational and financial improvements we've made over the last several years now.
Speaker Change: Now, let's turn to our first quarter performance.
Speaker Change: Turning to slide five.
Speaker Change: In the first quarter of 2025, we made meaningful progress across every facet of the business strategically operationally and financially progress that continues to position us well to realize the full potential of the vascepa franchise and maximize value for patients and shareholders.
Speaker Change: Overall, we've made progress in our three key segments.
Speaker Change: First in Europe on the commercialization front the skipper revenues continue the gradual growth we saw in 2024 with $5 4 million in revenues in the quarter, representing 16% sequential quarterly growth.
Speaker Change: This early at meaningful growth was driven by continued success in Spain, the U K and central Eastern Europe markets.
Speaker Change: Building on the success, we continue to find ways to accelerate growth, where <unk> has been launched.
Speaker Change: In Italy, the team has been focused on pricing and reimbursement to expand regional access we've.
Speaker Change: We have secured access a 14 or 21 local regions to date, which represent more than 85% of the total eligible market in Italy, reflecting positive interest in high density areas.
Speaker Change: This initial market access work sets the stage for a more efficient and effective broad commercial launch to drive anticipated growth.
Speaker Change: Later in 2025.
Speaker Change: Elsewhere in Europe, our team has made meaningful progress on market access and advancing pricing and reimbursement efforts.
Speaker Change: Specifically, we secured reimbursement in Austria and launched commercially in April.
Speaker Change: We also continue active engagement with the authorities in Norway, and Ireland with decisions in those markets is expected later this year.
Speaker Change: Second in the U S. We are continuing to efficiently generate cash with vascepa more than four years. After the introduction of the first generic products.
Speaker Change: We began 2025, while retaining all of our major exclusive accounts from Q4 2024 and that continued through the first quarter.
Speaker Change: This is a positive sign as we continue focusing on generating revenue and maximizing the profitability of the U S branded business.
Speaker Change: Similar to the seasonality impact we experienced in 2023 and 2024, we expect to see prescription volume pickup in the second quarter with possible declines in the third and fourth quarter.
Speaker Change: Moving forward given market dynamics, while we anticipate year over year declines consistent with prior years, we continue to extract strong value from the U S through efficient focused commercial execution and remain prepared to launch our authorized generic when deemed necessary and advantageous to the company.
Speaker Change: To fully maximize the contribution from the product through its lifecycle.
Speaker Change: And third across various regions and the rest of the world.
Speaker Change: 2024 was a year, where together with our partners, we drove regulatory progress in many markets and in 2025 has shifted to focusing on early commercialization.
We began 2025 by working with our partners to drive early demand for Vascepa across many markets.
Speaker Change: Any farm in China continued advancing promotional efforts in cardiovascular risk reduction for at risk patients with access to private hospitals and high risk patients in public hospitals with inpatient Acs patients is the priority in this initial stage of the commercial CVR launch.
Speaker Change: Your efforts are currently focused on the self pay market in China as they continue working towards inclusion on the national retail drug list or <unk> for 2026.
Speaker Change: As a reminder, China is a very large market opportunity for Vascepa with an estimated 330 million CBD patients and one of the highest CVD death rates in the world.
Speaker Change: According to a recent report on cardiovascular health and disease in China, CBD accounted for 44% to 47% of all deaths in urban and rural areas, meaning two out of every five deaths were due to CBD.
Speaker Change: We're confident Eddie can make a difference in this critical market with Vascepa.
Speaker Change: In Australia to the efforts with our partner CSL secures. The schedule was included in a new clinical guidelines for diagnosing and managing acute coronary syndromes issued by the National Heart Foundation of Australia, a cardiac society of Australia, and New Zealand.
Speaker Change: And most recently the 2020 for addition of management of type two diabetes, a handbook for general practice by the Royal Australian colleagues are general practitioners now includes best gap.
Speaker Change: In the lipid lowering medication overview section under complications type two diabetes and cardiovascular risks.
Speaker Change: This means we now have two strong local clinical recommendations supporting vascepa use.
Speaker Change: These are important milestones that reinforce the value of the scaffold and helping reduce cardiovascular risk and high risk patients from those patients with recent Acs to those living with diabetes.
Speaker Change: While still very early in the launch CSL. So curious is continuing to see strong end market demand for <unk>.
Speaker Change: The opportunity to make an impact on cardiovascular disease risk in this market is notable and we've seen a steady end market demand increase since launch in January.
Speaker Change: According to the Australian Institute of Health and welfare, approximately $1 3 million patients in Australia have established cardiovascular disease, which represents a significant opportunity for a CFO.
Speaker Change: Biologics continued to advanced market access efforts in the Mena region, including important progress with the Ministry of health in Saudi Arabia to further expand access for patients with public reimbursement there.
Speaker Change: This progress is important because with over 30% of adults over 18 at risk of CBD in the Kingdom of Saudi Arabia, There is an urgent need to address CBD there.
Speaker Change: Across southeast Asia regulatory efforts advanced in seven additional markets led by our partner Lotus currently keeping us on track for first approval in the region in 2026. These.
Speaker Change: These markets provide additional opportunities to drive future growth.
Speaker Change: In addition, we continue to advance the science supporting Vascepa globally by leveraging our medical affairs team to attendance and international Kols involvement in education, and multiple major global and regional medical conferences complemented by local educational efforts to strengthen scientific advocacy and launch.
Speaker Change: Activities.
Speaker Change: We also continue to pursue securing additional scientific publications in numerous regions locally primarily focused on commercialized markets.
Speaker Change: Together these efforts reinforce a growing global demand and potential for Vascepa backed by our solid foundation of science regulatory approvals and partnerships with strong commercial presence.
Speaker Change: From a financial perspective, we took decisive action to address a key overhang for the company and continue to make smart decisions to balance spending with cash preservation always with a focus on driving shareholder value.
Speaker Change: Specifically, we took proactive action to address our listing status with NASDAQ by completing a one for 2000 <unk> ratio change to preserve our NASDAQ listing.
Speaker Change: With this complete we have regained full compliance with Nasdaq.
Speaker Change: And we continue to keep our operating expenses in line and importantly retained a solid cash position with no debt.
Speaker Change: In summary, the first quarter, providing continued foundational progress for our path ahead.
Speaker Change: We are a global product with a broad label in many markets demonstrating proven therapeutic impact and value in the fight against CVD. The number one killer worldwide and in changing the lives of at risk patients wherever it's available.
Speaker Change: We have a global network supporting Vascepa.
Speaker Change: Amarin has a solid financial base with no debt that can support our operations and growth into the future.
Speaker Change: And we have a dedicated team committed to seeing through the realization of the true potential of Vascepa and further cementing our role in impacting the lives of patients worldwide.
Speaker Change: While we focused on the opportunity for this product around the world, We will do so prudently and with a significant focus on the bottom line as we've always done we will continue to look for opportunities to reduce operating expenses, while investing wisely to maximize the value of the product globally.
Speaker Change: And with that let me turn the call over to Pete Fishman, who will take us through the financial results.
Pete Fishman: Thank you Aaron good morning, everyone turning to slide seven 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 $56 5 million in the <unk>.
Speaker Change: First quarter of 2024.
Speaker Change: U S product revenue was $35 7 million compared to $48 1 million in the first quarter of 2020, it's.
Speaker Change: This decline was driven by lower net selling prices due to generic competition.
Speaker Change: Increasingly.
Speaker Change: As a reminder, we typically see the bulk of our full year U S declines in volume and price in the first quarter of the year.
Speaker Change: Despite the revenue decline the U S business continues to deliver significant.
Speaker Change: It's a remarkable track record for our branded products. This far out from the introduction of generics.
Speaker Change: European product revenue was five three.
Speaker Change: $3 5 million an increase over the prior year period, driven primarily by continued end market demand rate in Spain, the U K and central Eastern European markets broadest revenue also reflects revenue from our partnerships throughout the rest of the world where we are in the early stages commercialization and numerous.
Speaker Change: Regions.
Speaker Change: Well in the first quarter of 2025, we recorded minimal net product direct needs 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 quarters, and all geographies, where our partners at launch.
Speaker Change: 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 and market demand based on the growth trends seen in 2024.
Speaker Change: As Aaron mentioned earlier many of our partners are now shifting focus towards early commercialization and therefore, our partnership revenues will be variable quarter to quarter year to year based on restocking timing relative to end market demand.
Speaker Change: Cost of goods sold was $16 9 million in the first quarter compared to $24 6 million in the prior year period gross margin on product revenue was 59% compared to 55% in the prior year period, driven primarily by changes to the customers.
Speaker Change: Total operating expenses were $41 9 million, including $36 6 million in SG&A and $5 3 million in R&D, which is a reduction of approximately 8% compared to the prior year period.
Speaker Change: Flex, our efficient management of expenses and cash usage.
Speaker Change: Continue to focus on deploying our capital prudently and value driven efforts to maximize the impact of <unk> for patients around the world.
Speaker Change: Turning to the bottom line first quarter 2025, net loss was $15 7 million compared to a net loss of $10 million in the prior year period, primarily reflecting the impact of the U S generic market.
Speaker Change: Turning to slide eight and our balance sheet.
Speaker Change: We have continued to focus on controlling costs and effectively managing our cash.
Speaker Change: As of March 31, 2025, Ameren has aggregate cash and investments of $282 million with no debt.
Speaker Change: We have continued to make significant progress right sizing our operations, while improving our strategic focus and navigating the ongoing challenges to our U S product revenue.
Speaker Change: While doing this we have also made investments further expand the reach of Vascepa globally.
Speaker Change: As a result of these efforts we have kept our cash burn below 10% over the last 10 quarters. We will continue to remain focused on operational expenditures to ensure prudent cash.
Speaker Change: In addition, we continue to make progress renegotiating supply purchase agreements, which has helped drive down our overall supply significantly over the last two years and right size, our supply commitments for current and future demand.
Importantly, given our current supply position and the setup of our overall supply chain, we have not seen any impact nor do we expect to see any material impact in future quarters from U S or ex U S tariffs.
Speaker Change: In summary, Amarin continues to have a solid financial base and strong capital structure to support our pad.
Aaron Berg: Let me now turn the call back over to Aaron for closing remarks, before we begin the Q&A.
Aaron Berg: Thanks Pete.
Aaron Berg: Turning to slide 10, as you've heard today. The company is in a very solid position as we begin 2025.
Aaron Berg: We've made progress across all of our priorities by proactively modifying our strategy to drive the future opportunity for growth.
Aaron Berg: We know there's more work to do to fully capitalize on the untapped global potential for Vascepa and we will continue to consider all opportunities available to us to ensure we unlock this value.
Aaron Berg: This is what continues to drive our priorities and guide the actions, we continue to take to maximize shareholder value.
Aaron Berg: I want to reiterate a key point that continues to bring us back to the global value potential for Vascepa.
Aaron Berg: Simply stated we have in our hands a product that could significantly help address discouraged that is cardiovascular disease today.
Aaron Berg: Still the number one killer globally.
Aaron Berg: Today, the shipper is available to clinicians and thats been proven to be a valuable tool in the global fight against cardiovascular disease.
Aaron Berg: We remain committed to accelerating the pace and expanding the scope of access to this tremendous drug.
Aaron Berg: In conjunction with widely used lipid lowering agents focus on LDL lowering there continues to be growing evidence that vascepa can directly address cardiovascular risks and potentially reduce the incidence of cardiovascular events worldwide.
Aaron Berg: That's the opportunity and clear mandate for us.
Aaron Berg: Finally, I'd like to take a moment to thank the entire amarin team and our partners around the world for their <unk>.
Aaron Berg: <unk> commitment and dedication efforts are deeply appreciated and know that youre impacting the lives of at risk patients around the world every day.
Aaron Berg: You.
Speaker Change: With that operator, let's begin the Q&A portion of the call.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
Speaker Change: One moment, please while we poll for questions.
Speaker Change: Your first question for today is from Jessica Fye with J P. Morgan.
Speaker Change: Hello. This is Adam on for Jess Thank you for taking our question I.
Speaker Change: I just wanted to ask rest of world revenues of less than <unk> 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.
Speaker Change: Thanks for the questions.
Speaker Change: So.
Speaker Change: Rest of the world.
Speaker Change: First of all we're very encouraged by the position. We're in in spite of the fact that there was.
Speaker Change: The revenues for Q1.
Speaker Change: We're limited as we said in the past.
Speaker Change: The the way that these individual countries report will make the quarterly revenue variable.
Speaker Change: And it will be choppy as we get started there are just launching we're very early.
Speaker Change: They're operating off a small base and the waste shipments go in some quarters there'll be there is some quarters they won't but overall, we expect growth.
Speaker Change: We are encouraged by the end market demand, we are seeing in the countries, where we've launched.
Speaker Change: And it's very recent.
Speaker Change: Heard in the script how early we are in so many of these countries.
Speaker Change: In the last 12 months, just launching getting off the ground, we learned from the experience in the U S.
Speaker Change: It's a brand that takes some time to build a foundation and it starts to ramp up but we have good partners. We know that there is an unmet need the product is being received well scientific foundation is being built pressing reimbursements being being being.
Speaker Change: Accessed and we're very encouraged and optimistic about what it will go going forward, but it still may be choppy.
Speaker Change: Quarter to quarter.
Speaker Change: Thank you.
Speaker Change: Your next question for today is from marijuana release with Leerink.
Speaker Change: Hi, This is amazing on for a while just one from us, but I'm really just more of a science question, but given the established data now on reduce it in cardiovascular outcomes.
Speaker Change: What additional real world evidence or clinical development plans do you have.
Speaker Change: But potentially expand labeling or strengthen.
Speaker Change: <unk> against generics.
Speaker Change: Particularly as we continue to see the evolution of lipid management landscape with.
Speaker Change: The newer emerging therapies.
Speaker Change: Thanks, Matt I appreciate the question. So I'll I'll start off and then we have Dr. Steve Ketchum here with us and Steve can add on so.
Speaker Change: I'll try and dissect the question a little bit.
Speaker Change: We were always looking and have been very active in generating new data to.
Speaker Change: To differentiate the product.
Speaker Change: Now I'll separate generics for a minute because.
Speaker Change: Because thats a little bit of a different.
Speaker Change: Different animal.
Speaker Change: But certainly just show the value of IP and the uniqueness of IP and given the number of publications.
Speaker Change: That job.
Speaker Change: That I cited in the script.
Speaker Change: Didn't even talk about what we've generated over the last decade really wishes.
Speaker Change: Hundreds and hundreds of publications showing the uniqueness and that's one thing that we've done exceptionally well and certainly sits reduce it the team has done a remarkable job mining that data to show the differentiation.
Speaker Change: Some of the new therapies, it's exciting to hear talk of LP little a or possible rebirth of ctrip inhibition in those products and look forward to where those products take us I think what's encouraging for US is one it shows they are still residual risk after LDL lowering alone.
Speaker Change: Even though they are focused on LDL lowering with Ctrip inhibitors that even with LDL is treated there is still significant cardiovascular events.
Speaker Change: And that's even when patients have ldls at a low and Thats, where vascepa comes in.
Speaker Change: And we generate a lot of data to show certainly reduce it showed that because it was on top of standard of care with.
Speaker Change: Vascepa is available today.
Speaker Change: With significant cardiovascular risk reduction so maybe those other products come out and maybe they are good for for a subsegment of patients individually.
Speaker Change: But this is a product that could certainly make a difference today and we certainly hope that the scientific community focuses on that.
Speaker Change: Even though in the U S.
Speaker Change: Challenged because it's generic market and our investment in medical education has been limited.
Speaker Change: Rest of the world in Europe.
Speaker Change: 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.
Speaker Change: To show that this product is available today and is unique and can make a difference in.
Speaker Change: Residual risk beyond standard of care.
Speaker Change: And that will be whether these new products come out or not and those products can be years away.
Speaker Change: But but today.
Speaker Change: <unk>.
Speaker Change: The scientific community and practitioners and patients everybody can benefit from vascepa to debt today and Thats one thing that.
Speaker Change: 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 chose the uniqueness as well absolutely. So of course reduce it is the focal point of our development program and we continue.
Aaron Berg: Can use to be a rich data source and as Aaron mentioned, we've focused over the past period of time on.
Aaron Berg: Highlighting the strength of the data irrespective of baseline.
Aaron Berg: LC irrespective of baseline Lp's delay as Aaron mentioned, we do see.
Aaron Berg: We have a complementary therapy.
Got very robust data. We also continue to have a strong presence at.
Aaron Berg: All of the major international Medical Congresses.
Aaron Berg: Recently at ACC as Aaron mentioned, we continued to support data from external collaborators looking into mechanisms of action of EPA and this includes the anti inflammatory effects on various pathways.
Aaron Berg: Effect on protein expression, and we look forward to continuing to have a strong presence.
Aaron Berg: At future Congresses this year so.
Aaron Berg: Shannon.
Speaker Change: Just to build on it the data that's been generated that has led to over 50.
Speaker Change: Record online recommendations globally.
Speaker Change: And Thats because of the scientific foundation and the uniqueness of the product so.
Speaker Change: Today, there can be a difference made in cardiovascular risk reduction and that can be done with vascepa and best kept in other countries and.
Speaker Change: Really that's recognized increasingly given that we're so early in so many countries launching we think were poised for growth.
Speaker Change: Confident that we've made the right changes have the right strategy seen the effects of that have good partners.
Speaker Change: We're looking forward to it and we're very very bullish on where we will go going forward.
al: Thanks Al.
Speaker Change: Thank you for the top or bottom.
Speaker Change: We have reached the end of our question and answer session and I will now turn the call back to Aaron for closing remarks.
Aaron Berg: Okay. Thank you operator. Thank you thanks, everyone for taking the time to join US This morning, we.
Speaker Change: We appreciate the interest and continued.
Speaker Change: Continued interest in the company.
Speaker Change: Then as we said, we're we're looking forward to where we go moving.
Speaker Change: Moving ahead.
Speaker Change: Made the right changes and look forward to growth as we go forward and look forward to giving you further updates and thanks again for your time I appreciate it.
Speaker Change: This concludes today's conference and you may disconnect your lines at this time. Thank you.
Speaker Change: You for your participation.