NASDAQ:AMRN Amarin Q4 2024 Earnings Report $9.81 +0.34 (+3.59%) Closing price 04/15/2025 04:00 PM EasternExtended Trading$9.93 +0.12 (+1.26%) As of 07:00 AM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast Amarin EPS ResultsActual EPS-$2.40Consensus EPS -$1.20Beat/MissMissed by -$1.20One Year Ago EPSN/AAmarin Revenue ResultsActual Revenue$62.31 millionExpected Revenue$32.37 millionBeat/MissBeat by +$29.94 millionYoY Revenue GrowthN/AAmarin Announcement DetailsQuarterQ4 2024Date3/12/2025TimeBefore Market OpensConference Call DateWednesday, March 12, 2025Conference Call Time8:00AM ETUpcoming EarningsAmarin's Q1 2025 earnings is scheduled for Wednesday, May 7, 2025, with a conference call scheduled on Wednesday, April 30, 2025 at 8:00 AM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Annual Report (10-K)Earnings HistoryCompany ProfilePowered by Amarin Q4 2024 Earnings Call TranscriptProvided by QuartrMarch 12, 2025 ShareLink copied to clipboard.There are 8 speakers on the call. Operator00:00:00Welcome to Ameren Corporation's Conference Call to discuss its Fourth Quarter and Full Year twenty twenty four 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 Amarin. Speaker 100:00:19Good morning, everyone, and thank you for joining us. Turning to Slide two and 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. Speaker 100:00:48We 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 12/31/2024, which has been filed with the SEC and is available through the Investor Relations section of our website at www.amarancorp.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. Speaker 100:01:41Turning to Slide three in today's agenda. Aaron Burr, Amarin's President and Chief Executive Officer, will provide an update on the state of the Amarin business. Pete Fishman, Amarin's Chief Financial Officer, will review our fourth quarter financial results. And Steve Ketcham, Ameren's Executive Vice President, President of R and D and Chief Scientific Officer will provide an update on recent and upcoming Vascepa Aestepa research. And at the end of the presentation, Aaron Burr will provide closing remarks followed by a question and answer session. Speaker 100:02:16I will now turn the call over to Aaron Burr, President and Chief Executive Officer of Amarin. Aaron? Speaker 200:02:22Thank you, Mark. Good morning, everyone, and thank you for joining us here today. Let me begin my comments by focusing on our progress and the opportunity ahead to realize the value of Vascepa globally, as well as the ADS ratio change referenced in the press releases this morning, a strategic action we've taken to address a key issue for the company. Since taking on the role of CEO in the middle of last year, I've spent a significant part of that time working with our leadership team and in coordination with the Board of Directors to identify and take advantage of opportunities to rapidly accelerate momentum, strengthen the foundation for long term growth and drive greater value now and for the future. We've made progress in this effort and the opportunity that we have ahead with Vascepa is built on a strong foundation. Speaker 200:03:13We have a strong foundation financially with twenty twenty four revenues of over $200,000,000 and a cash position of almost $300,000,000 and no debt. This financial position helps solidify a long runway for Amarin. The science of Vascepa, which is underpinned by the REDUCE IT study and more than 500 additional publications advancing understanding of the icosapent ethyl clinical benefits and mechanism of action and its complementary position to impact the cardiovascular risk burden and unmet need around the world. This extensive science has helped to drive regulatory progress globally. To date, we've secured approvals in 49 markets around the world where we're in the early stages of obtaining pricing and reimbursement agreements, commercial launches or still progressing through the regulatory approval processes, all of which set the stage for future growth. Speaker 200:04:14Increasingly, we've expanded access to commercial penetration with the product launched in more than 20 markets globally, either directly or through our nine partnerships in place currently. There are also 16 additional countries in various stages of progress toward commercialization. The significant revenue generation led by continued capture of efficient branded revenue in The U. S. Followed by growth in Europe and rest of the world markets. Speaker 200:04:42This solid and growing foundation positions the Vascepa franchise to deliver on its tremendous opportunity globally. We know we have much more work to do to capitalize on this opportunity, but overall taking into consideration the considerable untapped potential of the franchise, our continued progress in its global expansion and the financial foundation and long cash runway we have in place, we believe there is a disconnect between the value potential and our current company valuation. Regarding the ADS ratio change, as a publicly traded company, we see considerable value in maintaining our NASDAQ listing. To that end, today we announced our intent to initiate a ratio change to our ADS program in order to preserve our NASDAQ listing. This step is an expression of our determination and commitment to realizing the full value potential of Amarin. Speaker 200:05:39Pete will cover this in greater detail later in the presentation and I encourage everyone to review today's press release on this matter for additional information. Turning to Slide six. Let me now briefly walk you through the past twelve months plus and provide details on our progress and key accomplishments, including the strategic decisions and steps we've taken that have helped us drive value. From a strategic standpoint, we successfully extended our intellectual property position in Europe, widening our IP horizon for Vazqueza through 02/1939. This is important as it extends the runway for exclusivity and the opportunity for this brand in Europe. Speaker 200:06:21We've continued to execute our new commercial and pricing and reimbursement strategy in Europe, tailored to each country and focused on very high risk patients. These are patients with established cardiovascular disease and there are currently over five million such patients in Europe, a significant opportunity to impact a large patient population. This strategy has accelerated our progress in the region. We've secured pricing and reimbursement in 10 markets since adopting this new strategy and in market demand grew in every launch market in Q4 versus Q3. We've also continued to focus our financial strategy on efficient cash management and and operating expense deployment focused only on the most value driving efforts. Speaker 200:07:06This has helped us extend our cash runway. Finally, as I mentioned, we announced earlier this morning that we're taking steps to maintain one of our critical corporate assets, our NASDAQ listing. Operationally, we've made continued progress across the business. In Europe, on the commercialization front, Vazqueza revenues continued to gradually increase throughout 2024, driven by growth in Spain, The UK and Central Eastern Europe markets. While we've seen early demand in a number of these markets, we must find ways to accelerate growth where Veschepa has been launched. Speaker 200:07:46Pricing reimbursement efforts have also advanced with pricing reimbursement secured in Italy, Portugal, Greece and most recently last month in Austria. Importantly, in Italy, we've already secured access in nine regions, which represent more than 50% of the total eligible market in that country, reflecting strong interest in gaining access to the product in the market. In The U. S, throughout 2024, we've continued to efficiently generate cash with Vascepa more than four years after the introduction of generic products. Exclusives, which now represent 74% of the total Vascepa branded business, cover approximately 43,000,000 total lives, which represents approximately 40% of the total commercial and Medicare Part D IPE volume. Speaker 200:08:42Additionally, as we previously stated, we have a plan of action and are prepared to launch an authorized generic when the time is optimal. Across various regions in the rest of the world, 2024 saw continued progress in regulatory efforts, expanding access and generating demand for Vascepa through existing partnerships. While early in the launch phase for a number of these markets, all partners saw growth in market demand for the product in Q4 and continue to work to expand access and further accelerate growth. Two of our partners launched in cardiovascular risk reduction, Enig Pharma in China and CSL Securus in Australia. Enig Pharma received regulatory approval in China mid year for cardiovascular risk reduction and are now focused on promoting for at risk patients with access to private hospitals and high risk patients in public hospitals with inpatient acute coronary syndrome patients as the priority in this initial stage of the commercial cardiovascular risk reduction launch. Speaker 200:09:47Their effort is currently focused on the self pay market in China as they continue advancing efforts to support inclusion on the National Retail Drug Listing or NRDL. In Australia, our partner CSL Securus secured Australia's Pharmaceutical Benefits Scheme or PBS price listing for VASCEPA unlocking public access to the product for patients with ASCVD and elevated triglycerides in that market. CSL officially launched at the annual scientific meeting of the Cardiac Society of Australia and New Zealand in August 2024, the largest cardiology meeting in Australia and New Zealand with more than 400 delegates attending. While very early, they're seeing strong end market demand in Australia. HLS received reimbursement in Alberta to round out their full public access across the country, adding opportunity for growth beyond their significant private insurance coverage for Canada. Speaker 200:10:49Biologics in the MENA region progressed their commercial efforts and saw increased sales in the region. They work to continue their growth in Saudi Arabia specifically as they work with the health authorities to further expand access to the patients with public reimbursement there. We continue to progress our regulatory efforts in Southeast Asia where our partner is LOTUS and expect first approvals to be sometime in 2026. Amarin continues to support our partner with our medical team to attendance and international scientific leader involvement at multiple medical conferences, specific scientific leader programs, launch efforts as well as working to secure publications locally for the commercialized regions. Supporting our efforts to generate worldwide growth are our medical affairs, R and D and regulatory teams who continue to expertly and tirelessly advocate for and advance the science behind Vascepa. Speaker 200:11:47More than five years from the approval of Vascepa in The U. S. For cardiovascular risk reduction, we and others are continuing to generate meaningful data that helps the clinical community further understand the underlying science and the potential added benefit of Vascepa to further reduce the risk of cardiovascular events in patients on standard of care therapy with well controlled LDL levels. This significant and continuously expanding body of evidence helps propel our commercial, medical advocacy and regulatory progress, which Steve will review in greater detail later. And finally, from a financial perspective, we continue to make smart decisions to balance operating expenses and cash preservation with the urgent need to accelerate global revenue growth. Speaker 200:12:39Specifically, we closed out 2024 having generated $228,600,000 in total revenue and a stable capital structure. For the year, we reduced our year over year operating expenses by 26%, including the $50,000,000 annual operating expense reduction we committed to in 2023. We ended the year with a strong cash position of $294,000,000 underscoring our prudent cash management and continued focus on strengthening our financial foundation. These financial accomplishments were accompanied by our successful efforts to renegotiate product supply agreements. These successful negotiations allow us to align our short term supply commitments based on current demand in order to conserve important capital, while ensuring we can supply the brand across markets as we build momentum with a growing global customer base. Speaker 200:13:41In summary, 2024 was a year of continued progress in numerous aspects of our business, driven by the execution of the entire Amarin organization. We take very seriously our obligation to drive shareholder value and while we've made progress, we have much more work to do to drive shareholder value, primarily by urgently getting Vascepa into the hands of as many at risk patients around the world as possible. We know the unmet need is there and while the last several years have been challenging, we remain steadfast in our efforts to drive continued positive progress in realizing this product's global potential. We remain confident we will generate further momentum in 2025, building off 2024. With that, let me turn the call over to Pete Fishman, who will take us through the financial results as well as the specifics regarding the ADS ratio change announced earlier this morning. Speaker 200:14:38Pete? Speaker 300:14:38Thank you, Aaron. Good morning, everyone. Turning to Slide eight. In the fourth quarter of twenty twenty four, Amarin reported total net revenue of $62,300,000 including net product revenue of $60,100,000 and 2,200,000 of licensing and royalty revenue compared to total net revenue of $74,700,000 in the fourth quarter of twenty twenty three. U. Speaker 300:15:03S. Product revenue was $44,200,000 compared to $64,900,000 in the fourth quarter of twenty twenty three. This decline was driven by lower net selling price due to generic competition and a decrease in volume in the second half of the year stemming from CVS commercial moving from exclusive to not covered. Looking ahead, we anticipate we will continue to see the impact of this on our year over year comparisons through the first two quarters of twenty twenty five. Despite the revenue decline, The U. Speaker 300:15:35S. Business continues to deliver significant cash and as Aaron said earlier, to exhibit resilience with a remarkable track record for a branded product this far out from the introduction of generics. European product revenue was $4,000,000 a $2,500,000 increase over the prior year period and driven primarily by growing contributions from Spain and The UK. Fourth Quarter Twenty Twenty Four product revenue was consistent with prior quarter, which included supply shipments to our partner in Greece. Spain and The UK continue to be the current drivers of revenue growth for this important and evolving region. Speaker 300:16:15Product revenue also reflects revenue from our partnerships throughout the rest of the world of $11,900,000 a 7,700,000 increase over the prior year period. These partnerships continue to generate meaningful cash contributions with no direct costs incurred by the company. It is important to note that in the current year product revenue with our partners include supply shipments in preparation for market launches. Our partnership revenue can be variable quarter to quarter and year to year based on restocking timing relative to end market demand. Cost of goods sold excluding non cash inventory restructuring of $36,500,000 was $35,400,000 in the fourth quarter compared to twenty nine point six million dollars in the prior year period. Speaker 300:17:04Gross margin excluding non cash inventory restructuring was 41% compared to 58% in the prior year period as a result of a decline in net selling price in The U. S. Total operating expenses were $43,000,000 including $37,000,000 in SG and A and $6,000,000 in R and D, which is a reduction of approximately $7,000,000 compared to the prior year period and reflects the impact of the ongoing cost optimization initiatives. We will continue to focus on deploying our capital on value driven efforts. Turning to the bottom line, fourth quarter twenty twenty four GAAP net loss was $48,600,000 compared to a GAAP net loss of $5,800,000 in the prior year period, primarily reflecting the impact of The U. Speaker 300:17:52S. Generic market and the sizable effect on cost of goods sold as a result of non cash inventory restructuring charges. Turning to Slide nine and our efforts and results in controlling costs and effectively managing our cash. As of 12/31/2024, we reported aggregate cash and investments of $294,000,000 In addition and equally as important, we ended the year with no debt. Over the last two years, we have made significant progress in rightsizing our operations, while improving our strategic focus and navigating the ongoing challenges to our U. Speaker 300:18:30S. Product revenue. While doing this, we have also made investments to further expand the reach of Vascepa globally. As a result of these efforts, we have successfully maintained a stable cash position over the last nine quarters. To quantify that, our cash has only declined approximately 5% or less than $20,000,000 since year end 2022. Speaker 300:18:54Fundamental to that track record of prudence and success has been and will continue to be commitment to balancing combination of managing costs and pursuing strategic decisions and channels to urgently expand product revenue. Now let me pivot to this morning's announcement. As referenced by Aaron earlier in the call, we continue to believe that our stock is undervalued given the progress we've made and the global opportunity for Vascepa. Amerind's NASDAQ listing is important both for investors and for the company. For shareholders, a listing allows individuals and investment entities to participate in the growth of Vascepa through the public equity capital markets. Speaker 300:19:37With this in mind and with our commitment to remain listed on the NASDAQ, this morning we announced our intent to effect the ratio change on our ADSs from one ADS representing one ordinary share to the new ratio of one ADS representing 20 ordinary shares. The objective of the ratio change is intended to increase the per share market price of the company's ADSs to comply with NASDAQ's one dollars minimum bid price per share requirement and maintain the company's listing on the NASDAQ Capital Market. As a result of the ratio change, each Amarin ADS holder will see the number of ADSs they hold divided by 20. For example, if an Amarin ADS holder holds 100 ADSs on the effective date, the holder will hold five ADSs following the ADS ratio change. This ratio change also has the same effect on the company's total outstanding shares. Speaker 300:20:38Importantly, the overall value of the holders ADSs does not change as a direct result of the ADS ratio change. The effective date of the ratio change is expected to be on or about 04/11/2025. For the benefit of shareholders, we have posted to the Investor Relations section of the company's website a Q and A addressing key questions investors may have about the ratio change. Let me now turn the call over to Steve Ketchum, who will provide a research update on our progress with advancing Vascepa science, building global support from the medical community and furthering our regulatory progress. Steve? Speaker 400:21:21Thank you, Pete. Good morning, everyone. Before I discuss recent and upcoming research, I wanted to take a few moments to speak to critical foundational elements for Vascepa and its therapeutic value for patients around the world. Namely maintaining focused investment in research enables us to shed further light on the science behind our product and publishing results of such research helps to drive medical advocacy for our product. As Aaron mentioned, the molecule icosapent ethyl, the active ingredient in Vascepa is built on tremendous science. Speaker 400:21:56Since 2011, both Amarin and its partner investigators have supported more than 500 publications to advance our understanding around the science of icosapentenoic pentenoic acid or EPA component of this ethyl ester molecule. Research insights into both IPE and EPA are fundamental to furthering our primary goal of maximizing the value and impact potential of our product globally. Looking at 2024 specifically, we supported and delivered significant additional scientific research on IPE and EPA. Ameren and global medical and scientific collaborators supported 45 publications inclusive of accepted abstracts, posters, presentations, manuscripts, review articles and book chapters across the past year. The breadth and depth of our ongoing scientific efforts has fueled significant global medical advocacy for IPE. Speaker 400:23:01In total, we have secured more than 50 clinical guidelines, consensus or scientific statements on the therapeutic value of Vascepa VASCEPA from global medical societies. Strong data from our REDUCE IT cardiovascular outcome study and from our supportive development program have directly driven our regulatory progress. Over the last three years, we have filed for regulatory review in 22 countries and regions and have received approval for the REDUCE IT clinical indication in 15 countries and regions outside of The United States and EMA regulatory approval authority, including in Mainland China, Switzerland, Australia, New Zealand and Israel. And we and our partners are advancing regulatory processes in seven additional rest of world markets. Turning to Slide 12 in support of clinical data, a post hoc analysis of REDUCE IT was recently published in the Journal of the American Heart Association evaluating the impact of icosapent ethyl on patients with various LDL C levels at baseline. Speaker 400:24:12This analysis showed consistent cardiovascular risk reduction benefit irrespective of baseline LDL C level. Even when a patient had a very low baseline LDL C level less than 55 milligrams per deciliter or down to 40 milligrams per deciliter, patients were still at risk and derive cardiovascular benefit taking Vascepa. This data reinforces that Vascepa is a complementary therapy to current LDL C lowering therapies. In other words, one of the primary advantages of Vascepa is that it can be added to standard of care or SoC LDL C lowering therapies and still further reduce the residual cardiovascular risk of a major cardiovascular event. By Vascepa being complementary, there is no need to displace LDL C lowering drugs. Speaker 400:25:04This is a commercial advantage for our product as it can be a significant challenge for companies with branded LDL C lowering drugs to compete head to head with other LDL C products. We firmly believe that the value of Vascepa as a complement to lipid lowering therapy should be more strongly considered by clinicians globally to help address and reduce residual cardiovascular risk. It should be noted that we are focusing on secondary prevention patients as many patients with well controlled LDL C still have major cardiovascular events including heart attacks and strokes. The groundbreaking results from the REDUCE IT outcomes trial prove that Vascepa lowered the chance of patients experiencing a life threatening cardiovascular event such as a heart attack or a stroke by twenty five percent when added to a statin. This is why medical providers should be aware of the REDUCE IT outcomes data and should add Vascepa on top of LDL C lowering statin therapy for their at risk patients rather than adding another LDL C lowering drug. Speaker 400:26:11Turning to Slide 13, our team will be supporting two abstracts at the upcoming American College of Cardiology meeting in Chicago later this month. The data being presented by investigators at ACC25 will further enhance the medical community's understanding regarding the potential mechanistic activities of EPA administered clinically in the form of Vascepa icosapent ethyl in reducing cardiovascular events in at risk patients. Specifically, the data will focus on the antioxidant effects of EPA on lipoprotein Lp enriched plasma and the effects of a GLP one receptor agonist in combination with EPA on the expression of antioxidant proteins in the endothelial cells in vitro. High Lp concentrations are associated with increased CD event risk and people with high levels face a two to four times greater risk of having an early event. With about twenty percent of the global population affected, research is crucial for understanding and addressing elevated Lp and the medical community has increased its focus on Lp as a key cardiovascular risk factor. Speaker 400:27:30We see potential value and opportunity for Vascepa and its potential impact to help address key areas driving residual cardiovascular event risk. Multiple new therapies are in development to treat CV risk beyond LTLC lowering. However, it is our view that clinicians should not wait for new agents when a product like Vascepa is already available for at risk patients. With the advancement of therapeutic approaches that address other domains residual CV risk, our ongoing research becomes more important because there could be additional therapeutic benefits whether overlapping protective mechanisms or additive mechanisms in combining EPA with emerging therapies like GLP-one receptor agonists that have been clearly shown to reduce CD risk on top of statin therapy. With widespread GLP-one use, there are likely an increasing number of patients with lipid abnormalities requiring statin therapy and with other comorbidities and risk factors that are in need of a complementary therapy like Vascepa to further reduce cardiovascular events. Speaker 400:28:43At Amarin, it is important for us to continue exploring the science behind IPE and the potential mechanisms by which EPA contributes to reducing CD risk. We intend to further advance this evidence base supporting the utility and value of Vascepa. Now, I'll turn the call back over to Aaron for closing remarks before we begin the Q and A. Aaron? Thanks, Steve. Speaker 200:29:08Turning to Slide 15. As you've heard today, we've made operational progress while also maintaining a solid financial foundation with a long cash runway and no debt. We have much more to do to capitalize on the untapped global potential for Siva. This is what drives our priorities and informs the steps we continue to take to maximize shareholder value. Let me reaffirm our priorities for 2025. Speaker 200:29:34First, we're focused on maintaining the critical NASDAQ listing by completing the ADR ratio change. Our public listing is important to us as a public company and to our shareholders. Second, we'll continue to focus on driving momentum in Europe where we have patent protection out to 02/1939 and the rest of the world through our partnerships. We remain early in the commercialization stages in these regions outside The U. S. Speaker 200:30:00And these are the regions that provide the greatest opportunity for long term revenue growth and overall value for shareholders. Third, we'll continue to drive efficient revenue while taking steps to maximize profitability in The U. S. Fourth, as Steve mentioned, there continues to be much more to learn about this unique molecule icosapent ethyl and we will continue to support research that drives greater understanding and awareness of the therapeutic value and impact of Vascepa for patients and payers. This is critically important as this product has proven to be tremendously valuable as a complementary cost effective therapy to widely use lipid lowering drugs in reducing cardiovascular risk. Speaker 200:30:48Finally, we'll continue to exhibit financial and operational discipline. While we focus on these critical strategic operational financial priorities in 2025, I want to end on a key point that brings us all back to the single biggest and most impactful opportunity before us, addressing the number one killer globally cardiovascular disease. As we sit here today, right now we have a product available to clinicians that has been proven to be a valuable tool to address this global challenge. In conjunction with widely used lipid lowering agents focused on LDL lowering, Vascepa can directly address cardiovascular risk and potentially change the curve of incidence of cardiovascular events worldwide. LDL lowering alone is not enough. Speaker 200:31:37Approximately thirty percent of patients that have experienced a myocardial infarction have well controlled LDL C at less than 55 and about fifteen percent to twenty percent of those patients will experience another event in one to three years. Providers can and need to do more for patients now to reduce cardiovascular events by addressing this risk head on. Today, millions of providers globally have the power and access to a proven therapy of Vascepa. We remain committed to accelerating the pace that they have access to and use our product in the name of helping patients from the world's leading cause of death, an essential priority for us here at Amarin. Before we turn to Q and A, I'd like to take a final moment to thank our Amarin colleagues and partners around the world for their continued commitment and dedication. Speaker 200:32:29Your efforts are deeply appreciated and know that you're impacting the lives of at risk patients around the world. So thank you. With that operator, let's begin the Q and A portion of the call. Operator00:32:42Certainly. At this time, we will be conducting a question and answer session. Your first question for today is from Jessica Fye with JPMorgan. Speaker 500:33:21Great. Good morning, guys. Thanks for taking my question. Can you talk about the factors influencing U. S. Speaker 500:33:27Net price in the fourth quarter? Came in a little bit higher than our estimate, looks like higher than net price over the past couple of quarters. So curious kind of what the drivers were there and just how to think about U. S. Net price in the coming quarters? Speaker 500:33:41Thank you. Speaker 200:33:43Hi, Jess. So first of all, just overall, as you know, it's an increasingly generic market and we the bulk of our business is in the exclusives, the branded business. But there is a mix of business that changes over time as well. And that can fluctuate quarter to quarter and cause some of that variability. I have Pete here with me as well who can provide some further detail on what happened in Q4. Speaker 300:34:12Sure. Just thanks for the question. As I mentioned, there is some variability in terms of the business mix and that's really the driver in terms of our Q4 revenue increase compared to prior quarters. As you know, in Q3, we lost CBS going the commercial going from exclusive to not covered. That continued into Q4 twenty twenty four from a volume perspective. Speaker 300:34:39And ultimately that's driving a shift in the business mix leading to higher going from higher rebates to lower rebates mix in the current year. When you look to the 2025, you're going to continue to see that volume impact and change in the first two quarters related to the CVS exclusive to not covered. And as Aaron noted, continued pricing pressure from the exclusive contracts. Operator00:35:13Thank you. Speaker 200:35:14Thank you. Operator00:35:18Your next question is from Ruana Ruiz with Leerink. Speaker 600:35:25Hi. This is Mazzi on for Ruana. Just one from us actually. So as you mentioned you ended the year with $300,000,000 in cash. So curious what your outlook is on building the pipeline either internally or externally through BD and what therapeutic areas are you most excited about? Speaker 200:35:46Thanks for the questions. So we from a BD perspective, we'll always be opportunistic. Our focus is of course on executing with Vascepa and certainly Vascepa in Europe and that's our focus and the cash that we have will be invested wisely to get a return on that. Now that being said, we do have a strong foundation and we'll look to it's always better to have a second product in the bag, if that presents an opportunity for us. The things that are presented to us, of course, we're a cardiovascular company primarily, but Cognitive Metabolic, There are a number of exciting things out there in development as well as commercial stage. Speaker 200:36:32But right now, we would probably focus on what our power alley is, if we get to that. But right now, we're focused on execution. We're focused on significant untapped potential with Vascepa globally and we really are just getting going. It's kind of the tale of two companies, right? The U. Speaker 200:36:50S. Is The U. S. And you certainly know where we are with that and we live it every day. But everywhere else, we're just getting going and with a long runway to 2,039 in Europe. Speaker 200:37:00We have a lot of opportunity, but a lot of work to do. Speaker 600:37:04Got it. Thank you so much. Operator00:37:11Your next question for today is from Paul Choi with Goldman Sachs. Speaker 700:37:17Hi, good morning. This is Daniel on for Paul. We were wondering if you could provide more colors on what is driving the rest of the world revenue growth and if there is like better geographical breakdown of the contributions? Thank you very much. Speaker 200:37:35Sorry, I didn't catch the last part of that on the contributions. Sorry Speaker 700:37:38about that. Yes. Could you provide more colors on the actual geographical breakdown of the Rest of the World contributions? Speaker 200:37:47Sure. So overall, just like in Europe, we're very early in most of those regions, just getting going, a lot of work to be done to establish medical advocacy to get access, access to not only private, but public. Every country is different, every region is different. And we're fortunate that we have some good partners that are experts in those respective regions and they're pretty passionate about the drug and they see that there's a lot of opportunity in their respective regions. But it takes time to get that access and then certainly public access, for example, we talked about China and now with Australia just coming online late last year, that's an opportunity for us. Speaker 200:38:34Both of those are decent sized markets, particularly of course we know how big China can be. We have a number of countries, we've Lotus in Asian and they have in the Asian region and they have a number of countries where we're progressing through the regulatory processes and look forward to getting those done and launched there. We have HLS in Canada and now that they've expanded to Alberta, as I mentioned in my prepared comments. Hopefully, they're able to get more growth in the public sector as well as that gets going. But I think overall, we're seeing the fundamentals of launching a drug and this is a drug that responds well once people are educated. Speaker 200:39:21As Steve mentioned, we have a lot of science to work with. We're well armed to promote the drug. There's clearly a unique place for this drug. It takes time to educate, but once you get providers educated, payers educated, the uptake is there and that's what we'll look forward to. So hopefully that answers your question. Speaker 700:39:41Yes, very helpful. Thank Speaker 400:39:46you. So that's the end Speaker 200:39:47of the questions that we have. So first, I just want to say thank you very much for your continued commitment and interest in Amarin and thanks for taking the time today. We appreciate it. Have a good day. Operator00:40:00This concludes today's conference and you may disconnect your lines at this time. Thank you for your participation.Read moreRemove AdsPowered by Conference Call Audio Live Call not available Earnings Conference CallAmarin Q4 202400:00 / 00:00Speed:1x1.25x1.5x2xRemove Ads Earnings DocumentsPress Release(8-K)Annual report(10-K) Amarin Earnings HeadlinesAmarin (NASDAQ:AMRN) Sets New 52-Week Low - Here's What HappenedApril 13 at 2:28 AM | americanbankingnews.comAmarin trading halted, news pendingApril 11, 2025 | markets.businessinsider.comTwo Unmistakable Patterns Return…The signs suggest we're entering one of those rare periods now. That's why Central Banks are buying gold at record pace. Why massive amounts of gold are being moved between countries. Why governments are repositioning their gold reserves. But here's what most people miss, the second pattern: During these resets, a unique anomaly appears in certain gold mining stocks. I call it the "Golden Anomaly."April 16, 2025 | Golden Portfolio (Ad)Amarin confirms effective data for 1-for-20 ADS ratio changeApril 9, 2025 | markets.businessinsider.comAmarin Confirms Effective Date for 1-For-20 ADS Ratio ChangeApril 9, 2025 | globenewswire.comAmarin Confirms Effective Date for 1-For-20 ADS Ratio ChangeApril 9, 2025 | globenewswire.comSee More Amarin Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Amarin? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Amarin and other key companies, straight to your email. Email Address About AmarinAmarin (NASDAQ:AMRN), a pharmaceutical company, engages in the development and commercialization of therapeutics for the treatment of cardiovascular diseases in the United States, European countries, Canada, Lebanon, and the United Arab Emirates. The company offers VASCEPA, a prescription-only omega-3 fatty acid product, used as an adjunct to diet for reducing triglyceride levels in adult patients with severe hypertriglyceridemia. It sells its products principally to wholesalers and specialty pharmacy providers. The company has a collaboration with Mochida Pharmaceutical Co., Ltd. to develop and commercialize drug products and indications based on the active pharmaceutical ingredient in Vascepa. The company was formerly known as Ethical Holdings plc and changed its name to Amarin Corporation plc in 1999. Amarin Corporation plc was incorporated in 1989 and is headquartered in Dublin, Ireland.View Amarin ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Why Analysts Boosted United Airlines Stock Ahead of EarningsLamb Weston Stock Rises, Earnings Provide Calm Amidst ChaosIntuitive Machines Gains After Earnings Beat, NASA Missions AheadCintas Delivers Earnings Beat, Signals More Growth AheadNike Stock Dips on Earnings: Analysts Weigh in on What’s NextAfter Massive Post Earnings Fall, Does Hope Remain for MongoDB?Semtech Rallies on Earnings Beat—Is There More Upside? Upcoming Earnings Netflix (4/17/2025)American Express (4/17/2025)Blackstone (4/17/2025)Infosys (4/17/2025)Marsh & McLennan Companies (4/17/2025)Charles Schwab (4/17/2025)Taiwan Semiconductor Manufacturing (4/17/2025)UnitedHealth Group (4/17/2025)HDFC Bank (4/18/2025)Progressive (4/18/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. Start Your 30-Day Trial MarketBeat All Access Features Best-in-Class Portfolio Monitoring Get personalized stock ideas. Compare portfolio to indices. Check stock news, ratings, SEC filings, and more. Stock Ideas and Recommendations See daily stock ideas from top analysts. Receive short-term trading ideas from MarketBeat. Identify trending stocks on social media. Advanced Stock Screeners and Research Tools Use our seven stock screeners to find suitable stocks. Stay informed with MarketBeat's real-time news. Export data to Excel for personal analysis. Sign in to your free account to enjoy these benefits In-depth profiles and analysis for 20,000 public companies. Real-time analyst ratings, insider transactions, earnings data, and more. Our daily ratings and market update email newsletter. Sign in to your free account to enjoy all that MarketBeat has to offer. Sign In Create Account Your Email Address: Email Address Required Your Password: Password Required Log In or Sign in with Facebook Sign in with Google Forgot your password? Your Email Address: Please enter your email address. Please enter a valid email address Choose a Password: Please enter your password. Your password must be at least 8 characters long and contain at least 1 number, 1 letter, and 1 special character. Create My Account (Free) or Sign in with Facebook Sign in with Google By creating a free account, you agree to our terms of service. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
There are 8 speakers on the call. Operator00:00:00Welcome to Ameren Corporation's Conference Call to discuss its Fourth Quarter and Full Year twenty twenty four 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 Amarin. Speaker 100:00:19Good morning, everyone, and thank you for joining us. Turning to Slide two and 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. Speaker 100:00:48We 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 12/31/2024, which has been filed with the SEC and is available through the Investor Relations section of our website at www.amarancorp.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. Speaker 100:01:41Turning to Slide three in today's agenda. Aaron Burr, Amarin's President and Chief Executive Officer, will provide an update on the state of the Amarin business. Pete Fishman, Amarin's Chief Financial Officer, will review our fourth quarter financial results. And Steve Ketcham, Ameren's Executive Vice President, President of R and D and Chief Scientific Officer will provide an update on recent and upcoming Vascepa Aestepa research. And at the end of the presentation, Aaron Burr will provide closing remarks followed by a question and answer session. Speaker 100:02:16I will now turn the call over to Aaron Burr, President and Chief Executive Officer of Amarin. Aaron? Speaker 200:02:22Thank you, Mark. Good morning, everyone, and thank you for joining us here today. Let me begin my comments by focusing on our progress and the opportunity ahead to realize the value of Vascepa globally, as well as the ADS ratio change referenced in the press releases this morning, a strategic action we've taken to address a key issue for the company. Since taking on the role of CEO in the middle of last year, I've spent a significant part of that time working with our leadership team and in coordination with the Board of Directors to identify and take advantage of opportunities to rapidly accelerate momentum, strengthen the foundation for long term growth and drive greater value now and for the future. We've made progress in this effort and the opportunity that we have ahead with Vascepa is built on a strong foundation. Speaker 200:03:13We have a strong foundation financially with twenty twenty four revenues of over $200,000,000 and a cash position of almost $300,000,000 and no debt. This financial position helps solidify a long runway for Amarin. The science of Vascepa, which is underpinned by the REDUCE IT study and more than 500 additional publications advancing understanding of the icosapent ethyl clinical benefits and mechanism of action and its complementary position to impact the cardiovascular risk burden and unmet need around the world. This extensive science has helped to drive regulatory progress globally. To date, we've secured approvals in 49 markets around the world where we're in the early stages of obtaining pricing and reimbursement agreements, commercial launches or still progressing through the regulatory approval processes, all of which set the stage for future growth. Speaker 200:04:14Increasingly, we've expanded access to commercial penetration with the product launched in more than 20 markets globally, either directly or through our nine partnerships in place currently. There are also 16 additional countries in various stages of progress toward commercialization. The significant revenue generation led by continued capture of efficient branded revenue in The U. S. Followed by growth in Europe and rest of the world markets. Speaker 200:04:42This solid and growing foundation positions the Vascepa franchise to deliver on its tremendous opportunity globally. We know we have much more work to do to capitalize on this opportunity, but overall taking into consideration the considerable untapped potential of the franchise, our continued progress in its global expansion and the financial foundation and long cash runway we have in place, we believe there is a disconnect between the value potential and our current company valuation. Regarding the ADS ratio change, as a publicly traded company, we see considerable value in maintaining our NASDAQ listing. To that end, today we announced our intent to initiate a ratio change to our ADS program in order to preserve our NASDAQ listing. This step is an expression of our determination and commitment to realizing the full value potential of Amarin. Speaker 200:05:39Pete will cover this in greater detail later in the presentation and I encourage everyone to review today's press release on this matter for additional information. Turning to Slide six. Let me now briefly walk you through the past twelve months plus and provide details on our progress and key accomplishments, including the strategic decisions and steps we've taken that have helped us drive value. From a strategic standpoint, we successfully extended our intellectual property position in Europe, widening our IP horizon for Vazqueza through 02/1939. This is important as it extends the runway for exclusivity and the opportunity for this brand in Europe. Speaker 200:06:21We've continued to execute our new commercial and pricing and reimbursement strategy in Europe, tailored to each country and focused on very high risk patients. These are patients with established cardiovascular disease and there are currently over five million such patients in Europe, a significant opportunity to impact a large patient population. This strategy has accelerated our progress in the region. We've secured pricing and reimbursement in 10 markets since adopting this new strategy and in market demand grew in every launch market in Q4 versus Q3. We've also continued to focus our financial strategy on efficient cash management and and operating expense deployment focused only on the most value driving efforts. Speaker 200:07:06This has helped us extend our cash runway. Finally, as I mentioned, we announced earlier this morning that we're taking steps to maintain one of our critical corporate assets, our NASDAQ listing. Operationally, we've made continued progress across the business. In Europe, on the commercialization front, Vazqueza revenues continued to gradually increase throughout 2024, driven by growth in Spain, The UK and Central Eastern Europe markets. While we've seen early demand in a number of these markets, we must find ways to accelerate growth where Veschepa has been launched. Speaker 200:07:46Pricing reimbursement efforts have also advanced with pricing reimbursement secured in Italy, Portugal, Greece and most recently last month in Austria. Importantly, in Italy, we've already secured access in nine regions, which represent more than 50% of the total eligible market in that country, reflecting strong interest in gaining access to the product in the market. In The U. S, throughout 2024, we've continued to efficiently generate cash with Vascepa more than four years after the introduction of generic products. Exclusives, which now represent 74% of the total Vascepa branded business, cover approximately 43,000,000 total lives, which represents approximately 40% of the total commercial and Medicare Part D IPE volume. Speaker 200:08:42Additionally, as we previously stated, we have a plan of action and are prepared to launch an authorized generic when the time is optimal. Across various regions in the rest of the world, 2024 saw continued progress in regulatory efforts, expanding access and generating demand for Vascepa through existing partnerships. While early in the launch phase for a number of these markets, all partners saw growth in market demand for the product in Q4 and continue to work to expand access and further accelerate growth. Two of our partners launched in cardiovascular risk reduction, Enig Pharma in China and CSL Securus in Australia. Enig Pharma received regulatory approval in China mid year for cardiovascular risk reduction and are now focused on promoting for at risk patients with access to private hospitals and high risk patients in public hospitals with inpatient acute coronary syndrome patients as the priority in this initial stage of the commercial cardiovascular risk reduction launch. Speaker 200:09:47Their effort is currently focused on the self pay market in China as they continue advancing efforts to support inclusion on the National Retail Drug Listing or NRDL. In Australia, our partner CSL Securus secured Australia's Pharmaceutical Benefits Scheme or PBS price listing for VASCEPA unlocking public access to the product for patients with ASCVD and elevated triglycerides in that market. CSL officially launched at the annual scientific meeting of the Cardiac Society of Australia and New Zealand in August 2024, the largest cardiology meeting in Australia and New Zealand with more than 400 delegates attending. While very early, they're seeing strong end market demand in Australia. HLS received reimbursement in Alberta to round out their full public access across the country, adding opportunity for growth beyond their significant private insurance coverage for Canada. Speaker 200:10:49Biologics in the MENA region progressed their commercial efforts and saw increased sales in the region. They work to continue their growth in Saudi Arabia specifically as they work with the health authorities to further expand access to the patients with public reimbursement there. We continue to progress our regulatory efforts in Southeast Asia where our partner is LOTUS and expect first approvals to be sometime in 2026. Amarin continues to support our partner with our medical team to attendance and international scientific leader involvement at multiple medical conferences, specific scientific leader programs, launch efforts as well as working to secure publications locally for the commercialized regions. Supporting our efforts to generate worldwide growth are our medical affairs, R and D and regulatory teams who continue to expertly and tirelessly advocate for and advance the science behind Vascepa. Speaker 200:11:47More than five years from the approval of Vascepa in The U. S. For cardiovascular risk reduction, we and others are continuing to generate meaningful data that helps the clinical community further understand the underlying science and the potential added benefit of Vascepa to further reduce the risk of cardiovascular events in patients on standard of care therapy with well controlled LDL levels. This significant and continuously expanding body of evidence helps propel our commercial, medical advocacy and regulatory progress, which Steve will review in greater detail later. And finally, from a financial perspective, we continue to make smart decisions to balance operating expenses and cash preservation with the urgent need to accelerate global revenue growth. Speaker 200:12:39Specifically, we closed out 2024 having generated $228,600,000 in total revenue and a stable capital structure. For the year, we reduced our year over year operating expenses by 26%, including the $50,000,000 annual operating expense reduction we committed to in 2023. We ended the year with a strong cash position of $294,000,000 underscoring our prudent cash management and continued focus on strengthening our financial foundation. These financial accomplishments were accompanied by our successful efforts to renegotiate product supply agreements. These successful negotiations allow us to align our short term supply commitments based on current demand in order to conserve important capital, while ensuring we can supply the brand across markets as we build momentum with a growing global customer base. Speaker 200:13:41In summary, 2024 was a year of continued progress in numerous aspects of our business, driven by the execution of the entire Amarin organization. We take very seriously our obligation to drive shareholder value and while we've made progress, we have much more work to do to drive shareholder value, primarily by urgently getting Vascepa into the hands of as many at risk patients around the world as possible. We know the unmet need is there and while the last several years have been challenging, we remain steadfast in our efforts to drive continued positive progress in realizing this product's global potential. We remain confident we will generate further momentum in 2025, building off 2024. With that, let me turn the call over to Pete Fishman, who will take us through the financial results as well as the specifics regarding the ADS ratio change announced earlier this morning. Speaker 200:14:38Pete? Speaker 300:14:38Thank you, Aaron. Good morning, everyone. Turning to Slide eight. In the fourth quarter of twenty twenty four, Amarin reported total net revenue of $62,300,000 including net product revenue of $60,100,000 and 2,200,000 of licensing and royalty revenue compared to total net revenue of $74,700,000 in the fourth quarter of twenty twenty three. U. Speaker 300:15:03S. Product revenue was $44,200,000 compared to $64,900,000 in the fourth quarter of twenty twenty three. This decline was driven by lower net selling price due to generic competition and a decrease in volume in the second half of the year stemming from CVS commercial moving from exclusive to not covered. Looking ahead, we anticipate we will continue to see the impact of this on our year over year comparisons through the first two quarters of twenty twenty five. Despite the revenue decline, The U. Speaker 300:15:35S. Business continues to deliver significant cash and as Aaron said earlier, to exhibit resilience with a remarkable track record for a branded product this far out from the introduction of generics. European product revenue was $4,000,000 a $2,500,000 increase over the prior year period and driven primarily by growing contributions from Spain and The UK. Fourth Quarter Twenty Twenty Four product revenue was consistent with prior quarter, which included supply shipments to our partner in Greece. Spain and The UK continue to be the current drivers of revenue growth for this important and evolving region. Speaker 300:16:15Product revenue also reflects revenue from our partnerships throughout the rest of the world of $11,900,000 a 7,700,000 increase over the prior year period. These partnerships continue to generate meaningful cash contributions with no direct costs incurred by the company. It is important to note that in the current year product revenue with our partners include supply shipments in preparation for market launches. Our partnership revenue can be variable quarter to quarter and year to year based on restocking timing relative to end market demand. Cost of goods sold excluding non cash inventory restructuring of $36,500,000 was $35,400,000 in the fourth quarter compared to twenty nine point six million dollars in the prior year period. Speaker 300:17:04Gross margin excluding non cash inventory restructuring was 41% compared to 58% in the prior year period as a result of a decline in net selling price in The U. S. Total operating expenses were $43,000,000 including $37,000,000 in SG and A and $6,000,000 in R and D, which is a reduction of approximately $7,000,000 compared to the prior year period and reflects the impact of the ongoing cost optimization initiatives. We will continue to focus on deploying our capital on value driven efforts. Turning to the bottom line, fourth quarter twenty twenty four GAAP net loss was $48,600,000 compared to a GAAP net loss of $5,800,000 in the prior year period, primarily reflecting the impact of The U. Speaker 300:17:52S. Generic market and the sizable effect on cost of goods sold as a result of non cash inventory restructuring charges. Turning to Slide nine and our efforts and results in controlling costs and effectively managing our cash. As of 12/31/2024, we reported aggregate cash and investments of $294,000,000 In addition and equally as important, we ended the year with no debt. Over the last two years, we have made significant progress in rightsizing our operations, while improving our strategic focus and navigating the ongoing challenges to our U. Speaker 300:18:30S. Product revenue. While doing this, we have also made investments to further expand the reach of Vascepa globally. As a result of these efforts, we have successfully maintained a stable cash position over the last nine quarters. To quantify that, our cash has only declined approximately 5% or less than $20,000,000 since year end 2022. Speaker 300:18:54Fundamental to that track record of prudence and success has been and will continue to be commitment to balancing combination of managing costs and pursuing strategic decisions and channels to urgently expand product revenue. Now let me pivot to this morning's announcement. As referenced by Aaron earlier in the call, we continue to believe that our stock is undervalued given the progress we've made and the global opportunity for Vascepa. Amerind's NASDAQ listing is important both for investors and for the company. For shareholders, a listing allows individuals and investment entities to participate in the growth of Vascepa through the public equity capital markets. Speaker 300:19:37With this in mind and with our commitment to remain listed on the NASDAQ, this morning we announced our intent to effect the ratio change on our ADSs from one ADS representing one ordinary share to the new ratio of one ADS representing 20 ordinary shares. The objective of the ratio change is intended to increase the per share market price of the company's ADSs to comply with NASDAQ's one dollars minimum bid price per share requirement and maintain the company's listing on the NASDAQ Capital Market. As a result of the ratio change, each Amarin ADS holder will see the number of ADSs they hold divided by 20. For example, if an Amarin ADS holder holds 100 ADSs on the effective date, the holder will hold five ADSs following the ADS ratio change. This ratio change also has the same effect on the company's total outstanding shares. Speaker 300:20:38Importantly, the overall value of the holders ADSs does not change as a direct result of the ADS ratio change. The effective date of the ratio change is expected to be on or about 04/11/2025. For the benefit of shareholders, we have posted to the Investor Relations section of the company's website a Q and A addressing key questions investors may have about the ratio change. Let me now turn the call over to Steve Ketchum, who will provide a research update on our progress with advancing Vascepa science, building global support from the medical community and furthering our regulatory progress. Steve? Speaker 400:21:21Thank you, Pete. Good morning, everyone. Before I discuss recent and upcoming research, I wanted to take a few moments to speak to critical foundational elements for Vascepa and its therapeutic value for patients around the world. Namely maintaining focused investment in research enables us to shed further light on the science behind our product and publishing results of such research helps to drive medical advocacy for our product. As Aaron mentioned, the molecule icosapent ethyl, the active ingredient in Vascepa is built on tremendous science. Speaker 400:21:56Since 2011, both Amarin and its partner investigators have supported more than 500 publications to advance our understanding around the science of icosapentenoic pentenoic acid or EPA component of this ethyl ester molecule. Research insights into both IPE and EPA are fundamental to furthering our primary goal of maximizing the value and impact potential of our product globally. Looking at 2024 specifically, we supported and delivered significant additional scientific research on IPE and EPA. Ameren and global medical and scientific collaborators supported 45 publications inclusive of accepted abstracts, posters, presentations, manuscripts, review articles and book chapters across the past year. The breadth and depth of our ongoing scientific efforts has fueled significant global medical advocacy for IPE. Speaker 400:23:01In total, we have secured more than 50 clinical guidelines, consensus or scientific statements on the therapeutic value of Vascepa VASCEPA from global medical societies. Strong data from our REDUCE IT cardiovascular outcome study and from our supportive development program have directly driven our regulatory progress. Over the last three years, we have filed for regulatory review in 22 countries and regions and have received approval for the REDUCE IT clinical indication in 15 countries and regions outside of The United States and EMA regulatory approval authority, including in Mainland China, Switzerland, Australia, New Zealand and Israel. And we and our partners are advancing regulatory processes in seven additional rest of world markets. Turning to Slide 12 in support of clinical data, a post hoc analysis of REDUCE IT was recently published in the Journal of the American Heart Association evaluating the impact of icosapent ethyl on patients with various LDL C levels at baseline. Speaker 400:24:12This analysis showed consistent cardiovascular risk reduction benefit irrespective of baseline LDL C level. Even when a patient had a very low baseline LDL C level less than 55 milligrams per deciliter or down to 40 milligrams per deciliter, patients were still at risk and derive cardiovascular benefit taking Vascepa. This data reinforces that Vascepa is a complementary therapy to current LDL C lowering therapies. In other words, one of the primary advantages of Vascepa is that it can be added to standard of care or SoC LDL C lowering therapies and still further reduce the residual cardiovascular risk of a major cardiovascular event. By Vascepa being complementary, there is no need to displace LDL C lowering drugs. Speaker 400:25:04This is a commercial advantage for our product as it can be a significant challenge for companies with branded LDL C lowering drugs to compete head to head with other LDL C products. We firmly believe that the value of Vascepa as a complement to lipid lowering therapy should be more strongly considered by clinicians globally to help address and reduce residual cardiovascular risk. It should be noted that we are focusing on secondary prevention patients as many patients with well controlled LDL C still have major cardiovascular events including heart attacks and strokes. The groundbreaking results from the REDUCE IT outcomes trial prove that Vascepa lowered the chance of patients experiencing a life threatening cardiovascular event such as a heart attack or a stroke by twenty five percent when added to a statin. This is why medical providers should be aware of the REDUCE IT outcomes data and should add Vascepa on top of LDL C lowering statin therapy for their at risk patients rather than adding another LDL C lowering drug. Speaker 400:26:11Turning to Slide 13, our team will be supporting two abstracts at the upcoming American College of Cardiology meeting in Chicago later this month. The data being presented by investigators at ACC25 will further enhance the medical community's understanding regarding the potential mechanistic activities of EPA administered clinically in the form of Vascepa icosapent ethyl in reducing cardiovascular events in at risk patients. Specifically, the data will focus on the antioxidant effects of EPA on lipoprotein Lp enriched plasma and the effects of a GLP one receptor agonist in combination with EPA on the expression of antioxidant proteins in the endothelial cells in vitro. High Lp concentrations are associated with increased CD event risk and people with high levels face a two to four times greater risk of having an early event. With about twenty percent of the global population affected, research is crucial for understanding and addressing elevated Lp and the medical community has increased its focus on Lp as a key cardiovascular risk factor. Speaker 400:27:30We see potential value and opportunity for Vascepa and its potential impact to help address key areas driving residual cardiovascular event risk. Multiple new therapies are in development to treat CV risk beyond LTLC lowering. However, it is our view that clinicians should not wait for new agents when a product like Vascepa is already available for at risk patients. With the advancement of therapeutic approaches that address other domains residual CV risk, our ongoing research becomes more important because there could be additional therapeutic benefits whether overlapping protective mechanisms or additive mechanisms in combining EPA with emerging therapies like GLP-one receptor agonists that have been clearly shown to reduce CD risk on top of statin therapy. With widespread GLP-one use, there are likely an increasing number of patients with lipid abnormalities requiring statin therapy and with other comorbidities and risk factors that are in need of a complementary therapy like Vascepa to further reduce cardiovascular events. Speaker 400:28:43At Amarin, it is important for us to continue exploring the science behind IPE and the potential mechanisms by which EPA contributes to reducing CD risk. We intend to further advance this evidence base supporting the utility and value of Vascepa. Now, I'll turn the call back over to Aaron for closing remarks before we begin the Q and A. Aaron? Thanks, Steve. Speaker 200:29:08Turning to Slide 15. As you've heard today, we've made operational progress while also maintaining a solid financial foundation with a long cash runway and no debt. We have much more to do to capitalize on the untapped global potential for Siva. This is what drives our priorities and informs the steps we continue to take to maximize shareholder value. Let me reaffirm our priorities for 2025. Speaker 200:29:34First, we're focused on maintaining the critical NASDAQ listing by completing the ADR ratio change. Our public listing is important to us as a public company and to our shareholders. Second, we'll continue to focus on driving momentum in Europe where we have patent protection out to 02/1939 and the rest of the world through our partnerships. We remain early in the commercialization stages in these regions outside The U. S. Speaker 200:30:00And these are the regions that provide the greatest opportunity for long term revenue growth and overall value for shareholders. Third, we'll continue to drive efficient revenue while taking steps to maximize profitability in The U. S. Fourth, as Steve mentioned, there continues to be much more to learn about this unique molecule icosapent ethyl and we will continue to support research that drives greater understanding and awareness of the therapeutic value and impact of Vascepa for patients and payers. This is critically important as this product has proven to be tremendously valuable as a complementary cost effective therapy to widely use lipid lowering drugs in reducing cardiovascular risk. Speaker 200:30:48Finally, we'll continue to exhibit financial and operational discipline. While we focus on these critical strategic operational financial priorities in 2025, I want to end on a key point that brings us all back to the single biggest and most impactful opportunity before us, addressing the number one killer globally cardiovascular disease. As we sit here today, right now we have a product available to clinicians that has been proven to be a valuable tool to address this global challenge. In conjunction with widely used lipid lowering agents focused on LDL lowering, Vascepa can directly address cardiovascular risk and potentially change the curve of incidence of cardiovascular events worldwide. LDL lowering alone is not enough. Speaker 200:31:37Approximately thirty percent of patients that have experienced a myocardial infarction have well controlled LDL C at less than 55 and about fifteen percent to twenty percent of those patients will experience another event in one to three years. Providers can and need to do more for patients now to reduce cardiovascular events by addressing this risk head on. Today, millions of providers globally have the power and access to a proven therapy of Vascepa. We remain committed to accelerating the pace that they have access to and use our product in the name of helping patients from the world's leading cause of death, an essential priority for us here at Amarin. Before we turn to Q and A, I'd like to take a final moment to thank our Amarin colleagues and partners around the world for their continued commitment and dedication. Speaker 200:32:29Your efforts are deeply appreciated and know that you're impacting the lives of at risk patients around the world. So thank you. With that operator, let's begin the Q and A portion of the call. Operator00:32:42Certainly. At this time, we will be conducting a question and answer session. Your first question for today is from Jessica Fye with JPMorgan. Speaker 500:33:21Great. Good morning, guys. Thanks for taking my question. Can you talk about the factors influencing U. S. Speaker 500:33:27Net price in the fourth quarter? Came in a little bit higher than our estimate, looks like higher than net price over the past couple of quarters. So curious kind of what the drivers were there and just how to think about U. S. Net price in the coming quarters? Speaker 500:33:41Thank you. Speaker 200:33:43Hi, Jess. So first of all, just overall, as you know, it's an increasingly generic market and we the bulk of our business is in the exclusives, the branded business. But there is a mix of business that changes over time as well. And that can fluctuate quarter to quarter and cause some of that variability. I have Pete here with me as well who can provide some further detail on what happened in Q4. Speaker 300:34:12Sure. Just thanks for the question. As I mentioned, there is some variability in terms of the business mix and that's really the driver in terms of our Q4 revenue increase compared to prior quarters. As you know, in Q3, we lost CBS going the commercial going from exclusive to not covered. That continued into Q4 twenty twenty four from a volume perspective. Speaker 300:34:39And ultimately that's driving a shift in the business mix leading to higher going from higher rebates to lower rebates mix in the current year. When you look to the 2025, you're going to continue to see that volume impact and change in the first two quarters related to the CVS exclusive to not covered. And as Aaron noted, continued pricing pressure from the exclusive contracts. Operator00:35:13Thank you. Speaker 200:35:14Thank you. Operator00:35:18Your next question is from Ruana Ruiz with Leerink. Speaker 600:35:25Hi. This is Mazzi on for Ruana. Just one from us actually. So as you mentioned you ended the year with $300,000,000 in cash. So curious what your outlook is on building the pipeline either internally or externally through BD and what therapeutic areas are you most excited about? Speaker 200:35:46Thanks for the questions. So we from a BD perspective, we'll always be opportunistic. Our focus is of course on executing with Vascepa and certainly Vascepa in Europe and that's our focus and the cash that we have will be invested wisely to get a return on that. Now that being said, we do have a strong foundation and we'll look to it's always better to have a second product in the bag, if that presents an opportunity for us. The things that are presented to us, of course, we're a cardiovascular company primarily, but Cognitive Metabolic, There are a number of exciting things out there in development as well as commercial stage. Speaker 200:36:32But right now, we would probably focus on what our power alley is, if we get to that. But right now, we're focused on execution. We're focused on significant untapped potential with Vascepa globally and we really are just getting going. It's kind of the tale of two companies, right? The U. Speaker 200:36:50S. Is The U. S. And you certainly know where we are with that and we live it every day. But everywhere else, we're just getting going and with a long runway to 2,039 in Europe. Speaker 200:37:00We have a lot of opportunity, but a lot of work to do. Speaker 600:37:04Got it. Thank you so much. Operator00:37:11Your next question for today is from Paul Choi with Goldman Sachs. Speaker 700:37:17Hi, good morning. This is Daniel on for Paul. We were wondering if you could provide more colors on what is driving the rest of the world revenue growth and if there is like better geographical breakdown of the contributions? Thank you very much. Speaker 200:37:35Sorry, I didn't catch the last part of that on the contributions. Sorry Speaker 700:37:38about that. Yes. Could you provide more colors on the actual geographical breakdown of the Rest of the World contributions? Speaker 200:37:47Sure. So overall, just like in Europe, we're very early in most of those regions, just getting going, a lot of work to be done to establish medical advocacy to get access, access to not only private, but public. Every country is different, every region is different. And we're fortunate that we have some good partners that are experts in those respective regions and they're pretty passionate about the drug and they see that there's a lot of opportunity in their respective regions. But it takes time to get that access and then certainly public access, for example, we talked about China and now with Australia just coming online late last year, that's an opportunity for us. Speaker 200:38:34Both of those are decent sized markets, particularly of course we know how big China can be. We have a number of countries, we've Lotus in Asian and they have in the Asian region and they have a number of countries where we're progressing through the regulatory processes and look forward to getting those done and launched there. We have HLS in Canada and now that they've expanded to Alberta, as I mentioned in my prepared comments. Hopefully, they're able to get more growth in the public sector as well as that gets going. But I think overall, we're seeing the fundamentals of launching a drug and this is a drug that responds well once people are educated. Speaker 200:39:21As Steve mentioned, we have a lot of science to work with. We're well armed to promote the drug. There's clearly a unique place for this drug. It takes time to educate, but once you get providers educated, payers educated, the uptake is there and that's what we'll look forward to. So hopefully that answers your question. Speaker 700:39:41Yes, very helpful. Thank Speaker 400:39:46you. So that's the end Speaker 200:39:47of the questions that we have. So first, I just want to say thank you very much for your continued commitment and interest in Amarin and thanks for taking the time today. We appreciate it. Have a good day. Operator00:40:00This concludes today's conference and you may disconnect your lines at this time. Thank you for your participation.Read moreRemove AdsPowered by