Amarin Corporation plc

Welcome to Ameren 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 Marmer, Vice President, Corporate Communications and Investor Relations at Ameren.

Good morning, everyone, and thank you for joining us. Turning to slide two in our forward-looking statements. 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. 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 March 31st, 2025, which have been filed with the SEC and are available through the investor relations section of our website at www.amroncorp.com. We encourage everyone to read these documents. An archive of this call will be posted on Amron's website in the investor relations section. Turning to slide three in today's agenda, Aaron Berg, Ameren's President and Chief Executive Officer, will provide an update on the state of our business. Pete Fishman, Ameren'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 Ameren. Aaron?

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 the SCEPA is estimated to be more than 6 million patients in 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 the SCEPA. 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 the SCEPA 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've 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 Vesipa is reimbursed and launched, from 7 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 impact and further diversify sources of revenue generation. We've stabilized Vesepa as a profitable enterprise in the US and have maintained a leading market share. Vesepa is accelerating revenue growth, albeit off a small base, across European markets with patent protection through 2039. While encouraging, we know there's tremendous untapped opportunity in Europe and room for significant growth. We've achieved regulatory and early commercial success through our rest of the world partnerships. Vesipa is now commercialized in nine rest-of-the-world markets to date through these partnerships. Our R&D and medical affairs teams have continued to advance the science behind Vesipa with nearly 100 abstracts and publications, more than 150 educational initiatives since 2023 across Europe, and a strong presence at major global medical congresses. And we've efficiently managed our cash over 10 consecutive quarters while maintaining a debt-free balance sheet. While we're proud of this progress, we know we're just scratching the surface of the SIPA's full potential in many markets globally. And we have much more work to do in pursuit of opportunities to unlock the value of the product and the company as a whole. We're moving with purpose. determined to advance patient treatment and reduce 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. This is very much top of mind for our board and management team and has been the guiding force behind the transformational strategic, operational, and financial improvements we've made over the last several years. Now let's turn to our first quarter performance. Turning to slide five, 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 Vesipa franchise and maximize value for patients and shareholders. Overall, we've made progress in our three key segments. First, in Europe, on the commercialization front, Vescapa revenues continued the gradual growth we saw in 2024, with $5.4 million in revenues in the quarter, representing 16% sequential quarterly growth. This early yet meaningful growth was driven by continued success in Spain, the UK, and Central Eastern Europe markets. Building on this success, we continue to find ways to accelerate growth where Vescapa has been launched. In Italy, the team has been focused on pricing and reimbursement to expand regional access. We've secured access in 14 of 21 local regions to date, which represent more than 85% of the total eligible market in Italy, reflecting positive interest in high-density areas. This initial market access work sets the stage for a more efficient and effective broad commercial launch to drive anticipated growth later in 2025. Elsewhere in Europe, our team has made meaningful progress on market access and advancing pricing and reimbursement efforts. Specifically, we secured reimbursement in Austria and launched commercially in April. We also continue active engagement with authorities in Norway and Ireland with decisions in those markets expected later this year. Second, in the U.S., we are continuing to efficiently generate cash with this SEPA more than four years after the introduction of the first generic products. We began 2025 by retaining all of our major exclusive accounts from Q4 2024, and that continued through the first quarter. This is a positive sign as we continue focusing on generating revenue and maximizing the profitability of the U.S.-branded business. Similar to the seasonality impact we experienced in 2023 and 2024, we expect to see prescription volume pick up in the second quarter with possible declines in the third and fourth quarter. 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 to fully maximize the contribution for the product through its lifecycle. And third, across various regions in the rest of the world, 2024 was a year where together with our partners, we drove regulatory progress in many markets and in 2025 have shifted to focusing on early commercialization. We began 2025 by working with our partners to drive early demand for Vesepa across many markets. Benning 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 as the priority in this initial stage of the commercial CVRR launch. Their efforts are currently focused on the self-pay market in China as they continue working towards inclusion on the National Retail Drug Listing, or NRDL, for 2026. As a reminder, China is a very large market opportunity for Vasepa, with an estimated 330 million CBD patients and one of the highest CBD death rates in the world. 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. We're confident Edding can make a difference in this critical market with the CIPA. In Australia, through the efforts with our partner CSL Securus, ASCEPA was included in a new clinical guideline for diagnosing and managing acute coronary syndromes issued by the National Heart Foundation of Australia and Cardiac Society of Australia and New Zealand. And most recently, the 2024 edition of Management of Type 2 Diabetes, a Handbook for General Practice by the Royal Australian College of General Practitioners, now includes Vescapa in the lipid lowering medication overview section under complications, type 2 diabetes, and cardiovascular risk. This means we now have two strong local clinical recommendations supporting Vescapa use. These are important milestones that reinforce the value of Vescapa in helping reduce cardiovascular risk in high-risk patients, from those patients with recent ACS to those living with diabetes. While still very early in the launch, CSL Securus is continuing to see strong in-market demand for Veskepa. The opportunity to make an impact on cardiovascular disease risk in this market is notable, and we've seen a steady in-market demand increase since launch in January. 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 Mesquepa. Biologics continue to advance 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. 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. 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 markets provide additional opportunities to drive future growth. In addition, We continue to advance the science supporting the SEPA globally by leveraging our medical affairs team through attendance and international KOL involvement in education and multiple major global and regional medical conferences, complemented by local educational efforts to strengthen scientific advocacy and launch activities. We also continue to pursue securing additional scientific publications in numerous regions locally, primarily focused on commercialized markets. Together, these efforts reinforced the growing global demand and potential for Vesipa, backed by a solid foundation of science, regulatory approvals, and partnerships with strong commercial presence. From a financial perspective, we took decisive action to address a key overhang for the company and continued to make smart decisions to balance spending with cash preservation, always with a focus on driving shareholder value. Specifically, we took proactive action to address our listing status on NASDAQ by completing a 1 for 20 ADS ratio change to preserve our NASDAQ listing. With this complete, we have regained full compliance with NASDAQ. And we continue to keep our operating expenses in line and importantly, retained a solid cash position with no debt. In summary, the first quarter provided continued foundational progress for our path ahead. We have a global product with a broad label in many markets, demonstrating proven therapeutic impact and value in the fight against CBD, the number one killer worldwide, and in changing the lives of at-risk patients wherever it's available. We have a global network supporting the SEPA, Ameren has a solid financial base with no debt that can support our operations and growth into the future, and we have a dedicated team committed to seeing through the realization of the true potential of a SEPA and further cementing our role in impacting the lives of patients worldwide. While we focus 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. And with that, let me turn the call over to Pete Fishman, who will take us through the financial results. Pete?

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 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. decline 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. 3.5 million increase over the prior year period, driven primarily by continued in-market demand growth in Spain, the UK, 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 focus toward early commercialization, and therefore our partnership revenue will be variable quarter-to-quarter and year-to-year based on restocking timing relative to in-market demand. 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 customer mix. 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 and reflects our efficient management of expenses and cash uses. We will continue to focus on deploying our capital prudently on value-driven efforts to maximize the impact of the SEPA for patients around the world. 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. Turning to slide eight and our balance sheet. We have continued to focus on controlling costs and effectively managing our cash. As of March 31st, 2025, Ameren has aggregate cash and investments of $282 million with no debt. We have continued to make significant progress by sizing our operations while improving our strategic focus and navigating the ongoing challenges to our U.S. product revenue. While doing this, we have also made investments to further expand the reach of the SIPA globally. 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 management. In addition, we continue to make progress renegotiating supply purchase agreements, which have helped draw 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 US or ex-US tariffs. In summary, Ameren continues to have a solid financial base and strong capital structure to support our path ahead. Let me now turn the call back over to Aaron for closing remarks before we begin the Q&A. Aaron?

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 BESIPA and will 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 Vasepa. 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, Vasepa 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 the CIPA can directly address cardiovascular risk and potentially reduce the incidence of cardiovascular events worldwide. That's the opportunity and clear mandate for us. Finally, I'd like to take a moment to thank the entire Ameren 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.

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. A 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. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

One moment, please, while we poll for questions. Your first question for today is from Jessica Fye with JP Morgan.

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.

Adam, 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 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. 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've 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 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 foundation's being built. Pricing reimbursement's being accessed. And we're very encouraged and optimistic about where we'll go going forward. But it's still maybe choppy quarter to quarter.

Thank you.

Your next question for today is from Rowana Ruiz with Lyrinc.

Hi, this is Mazion for Rowana. 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?

Thanks, Mazie. 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 give 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 little a or possible rebirth of CTEP inhibition and 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 C-temp inhibitors. And 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 Vesepa 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. But SEPA is available today with significant cardiovascular risk reduction. So maybe those other products come out and maybe they're good for a sub-segment 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 the CIPA 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.

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, you know, highlighting the strength of the data, irrespective of baseline LDLC, irrespective of baseline LP. 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.

Thanks, Aaron. And, Maisie, 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. Today, there can be a difference made in cardiovascular risk reduction, and that can be done with BASEPA and BASCEPA in 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 strategies, seen the effects of that, have good partners.

We're looking forward to it. We're very bullish on where we'll go going forward. Thank you.

Thank you for the thoughtful response.

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

Thank you, operator. 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 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.

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