Amarin Corporation (NASDAQ:AMRN) has reported its financial results for the second quarter of 2024, with a focus on the global expansion of its cardiovascular drug, VASCEPA/VAZKEPA. Despite facing generic competition and the loss of a major commercial account in the US, the company remains optimistic about the long-term potential of its product.
With a net revenue of $67.5 million for the quarter, Amarin has also achieved $50 million in cost savings and reported a GAAP net income of $1.5 million. The company's cash balance stands at $307 million, and it is exploring options to enhance shareholder value, including a potential reverse stock split, in light of a notice of potential delisting from NASDAQ.
Key Takeaways
- Amarin Corporation reported Q2 2024 net revenue of $67.5 million.
- The company faces challenges in the US due to generic competition and the loss of an exclusive commercial account.
- Amarin achieved public reimbursement for VASCEPA in China, a milestone that included a $15 million payment.
- Discussions on pricing and reimbursement for VASCEPA are in final stages in Australia.
- In Canada, VASCEPA will be listed starting August 1, 2024, in Alberta.
- Amarin is considering a reverse stock split among other options to comply with NASDAQ listing requirements.
- The Federal Circuit has reinstated Amarin's patent infringement lawsuit against Hikma, which will proceed in District Court.
Company Outlook
- Amarin anticipates a decline in revenues in the latter half of 2024 due to the loss of an important contract in the US.
- The company is prepared to launch an authorized generic of VASCEPA if necessary.
- Amarin is actively seeking reimbursement for VASCEPA in Italy and France and is investing in Europe, targeting acute coronary syndrome (ACS) patients.
Bearish Highlights
- The company is experiencing pressure from generics in the US and expects the trend to continue, with increased rebates and a potential decline in net selling price in 2025.
- Amarin lost a CVS commercial plan, impacting its US market presence.
Bullish Highlights
- Despite challenges, Amarin maintains market leadership in the US IPE market.
- The company has seen strong sales growth prospects in the UK, Spain, and China.
- Amarin's partner in China, Edding, has launched VASCEPA for the high triglyceride indication, with hopes for inclusion on the NRDL by January 2025.
Misses
- Amarin did not initiate share repurchases in Q2 2024 due to unfavorable business and market conditions.
Q&A Highlights
- The company is excited about the economic opportunities in China and is working with a strong partner to support expansion.
- In Europe, Amarin is taking a specialty approach to marketing VASCEPA, initially focusing on ACS patients and cardiologists before considering broader expansion.
Amarin Corporation's second quarter of 2024 reflects a strategic focus on overcoming challenges in the US market while expanding its global footprint. The company's efforts to secure reimbursement and pricing agreements in key markets are steps toward increasing the accessibility of VASCEPA/VAZKEPA to patients in need. With a prudent investment strategy and ongoing legal efforts to protect its intellectual property, Amarin is navigating a complex market landscape with a clear vision for the future.
InvestingPro Insights
Amarin Corporation's recent financial performance and strategic maneuvers have been closely monitored by investors, and real-time data from InvestingPro provides further insights into the company's market position and future prospects.
InvestingPro Data highlights include a market capitalization of $321.59 million, signaling a moderate size within the biopharmaceutical sector. The company's price-to-earnings (P/E) ratio stands at -6.64, indicating that investors are currently not expecting earnings growth in the near term. Additionally, the revenue for the last twelve months as of Q1 2024 is reported at $277.45 million, with a notable decline of -23.04% compared to the previous year, reflecting the challenges Amarin faces in the market.
From the InvestingPro Tips, two key points emerge:
1. Amarin holds more cash than debt on its balance sheet, which could provide some financial flexibility in its operations and strategic initiatives.
2. Analysts anticipate a sales decline in the current year, aligning with the company's own outlook and the competitive pressures it faces in the US market.
These insights suggest that while Amarin has some financial stability, it is also experiencing significant headwinds that may affect its performance. The company's focus on global expansion and securing reimbursement for VASCEPA in new markets is crucial as it faces a decline in sales and increased competition.
For readers interested in a deeper analysis, there are additional InvestingPro Tips available for Amarin, which can be found at https://www.investing.com/pro/AMRN. These tips provide a comprehensive view of the company's financial health, market potential, and operational strengths and weaknesses, offering valuable information for potential investors and stakeholders.
Full transcript - Amarin (AMRN) Q2 2024:
Operator: Welcome to Amarin Corporation’s Conference Call to discuss its Second Quarter 2024 Business Update and Financial Results. I would now like to turn the conference call over to Mark Marmur, Vice President, Corporate Communications and Investor Relations at Amarin.
Mark Marmur: Good morning, everyone, and thank you for joining us. Turning to our forward-looking statements. Please be aware that this conference call will contain forward-looking statements that are intended to be covered under the safe harbor provided under federal securities law. We may not achieve our goals, carry out our plans or intentions, or meet the expectations disclosed in our forward-looking statements. Actual results or events could differ materially, so you should not place undue reliance on these statements. We assume no obligation to update these statements as circumstances change. Our forward-looking statements do not reflect the potential impact of significant transactions we may enter into such as mergers, acquisitions, dispositions, joint ventures, or any material agreements that we may enter into, amend, or terminate. For additional information concerning the risk factors that could cause actual results to differ materially, please see the Risk Factors section of our annual report on Form 10-K for the year ended December 31, 2023, and our quarterly report on Form 10-Q for the quarter ended June 30, 2024, which has been filed with the SEC and is available through the Investor Relations section of our website at www.amarincorp.com. We encourage everyone to read these documents. An archive of this call will be posted on Amarin’s website in the Investor Relations section. Turning to today’s agenda, Aaron Berg, Amarin’s President and Chief Executive Officer, will provide an overview of his perspectives Amarin’s value and second quarter business progress; and Tom Reilly, Amarin’s Chief Financial Officer, will provide a review of our second quarter 2024 financial results. At the end of the presentation, there will be the chance to ask questions. I will now turn the call over to Aaron Berg, President and Chief Executive Officer of Amarin. Aaron?
Aaron Berg: Thank you, Mark. Good morning, everyone, and thank you for joining us today. I’m thrilled to be back leading Amarin in a very short time. As interim CEO last year, I was able to spearhead several key global strategic and organizational adjustments. Now back in the CEO role for just a few short weeks, it’s gratifying to see some of the impact of those changes. I’ve been with Amarin for over a decade and remain as passionate and committed to the company as when I started for several very important reasons. First of all, VASCEPA/VAZKEPA is an incredible product. Over the last ten years, more than 300 scientific publications have been generated, confirming the unique attributes of VASCEPA anchored by the landmark REDUCE-IT trial. Confirming that VASCEPA provides an important option for patients globally who need to reduce their risk of a cardiovascular event. I ran the U.S. commercial organization when the REDUCE-IT trial read out and when we subsequently secured the cardiovascular risk reduction indication. The reception of this remarkable data by the scientific community and the potential to positively impact millions of patients with VASCEPA generated incredible demand. Prescriptions increased significantly and product revenue rose substantially. We witnessed a greater than 50% increase in the number of prescribers resulting in more than 80% growth in new prescriptions in the first year post publication of REDUCE-IT. This evidence of uptake and market response provides evidence that with time to promote and educate supported by outstanding execution, providers respond favorably to VASCEPA as a therapy that can benefit their patients. Second, even with many advancements in therapies and scientific data, cardiovascular disease remains the number one killer globally, causing a significant financial burden and negatively impacting patients and their families. Additionally, millions of prescriptions are written globally each year for fibrates and omega-3 mixture products for patients with cardiovascular risk, even though they’re not beneficial in reducing cardiovascular risk. As a result, the reduction of cardiovascular events remains a top priority for healthcare providers, patients, caretakers, governments and the investment community. Our confidence remains steadfast that VASCEPA/VAZKEPA represents an important option in the global arsenal against cardiovascular disease, and therefore a true difference maker in patients’ lives. Third, unlike in the U.S., where we had time to commercialize VASCEPA prior to the publication of the REDUCE-IT data and the cardiovascular risk reduction indication, we’re in the early phases of our global expansion effort, targeting key markets around the world. To date, we’ve unlocked access and launched in some European markets. However, there remains significant potential to advance access to VASCEPA for many at risk patients in a number of additional critical markets. And finally, VAZKEPA has a long runway to generate revenue based on its strong IP position, particularly in Europe, where we have recently received extended patent rights into 2039. The combination of the strength and extent of clinical data, its runway and the opportunity for sustained growth and impact, together with the ability to save lives around the world, translate into a tremendous opportunity for us to maximize VASCEPA/VAZKEPA’s worldwide potential. Before we move on to operational performance in the second quarter, there are a few additional points I want to highlight about Amarin and how we’ll operate moving forward under my leadership. We have a fantastic team, smart, committed, passionate, and I can assure you that no one here is satisfied with our commercial progress. We’re always looking for ways that we can generate new ideas and improve execution, and we know we must find new ways to perform better and faster. As a significant shareholder with substantial vested interest in the company’s success, I’m determined to drive value for all of us and understand my responsibility to do just that. As I lead the company to build greater value, I think and act like a shareholder every day. My focus is clear to prioritize execution and performance while urgently evaluating opportunities to expand the impact of VASCEPA to millions of patients worldwide. That’s our commitment to provide value to patients, providers, payers and of course, shareholders. Let me now turn to some of the operational highlights from the quarter. Turning to Slide 6, in Europe, our teams are making progress in realizing incremental revenue growth, but we have much more work ahead of us. The seeds for recent growth were planted more than a year ago when we put a new strategy in place centered around targeting a more focused patient population, coupled with improved resource prioritization, all with a focus on enhancing the value proposition for VAZKEPA in the market that can deliver the greatest impact for patients. Part of the challenge we faced in Europe is the reality that compelling data such as, REDUCE-IT, many times clashes with budget realities in individual markets. A broader label creates an enormous opportunity in Europe due to the strength of the REDUCE-IT trial, which demonstrates that VAZKEPA can benefit millions of patients, all within the label. There are approximately seven million patients that meet the label criteria in Europe. While this is very powerful and the scale is an enormous opportunity for us, it’s also a challenge for the reimbursement authorities from a budget perspective. We need to respect that and work with the authorities to find the middle ground of helping as many patients as possible, while doing so in a manner that’s sensitive to the budget constraints. In 2023, we implemented a strategy to accelerate progress, which focuses on a higher risk subset of REDUCE-IT patients. This is intended to help us obtain favorable access and reimbursement more quickly, while preserving long-term potential, as well as accelerate sales growth upon launch with a more focused, efficient commercial structure. We’re seeing this strategy resonate with authorities and hope that once we establish momentum in key country providers, they will use the product to benefit more of their at-risk patients. In the second quarter, the team continued to deliver on this strategy and made advances. Specifically, Spain is delivering robust growth following our highly successful VAZKEPA launch in that country last fall. The early success in Spain further confirms what we learned from our promotional and educational efforts in the U.S. that when HCPs and payers learn about the science and benefits of VAZKEPA, this medication can sell in Europe. Our sales team there is targeting 2500 key HCPs covering 80% of the total market and augmenting our sales efforts with continued focus on a commercial and medical strategy centered on increased HCP interactions, regional congresses and publication plans. These efforts should help to solidify the case for VAZKEPA in this important European market and should serve as a model for how we expect to execute our strategy in other European markets. In the UK, we implemented significant impactful changes to accelerate growth. Our refined, focused commercial strategy, coupled with organizational changes including a new General Manager and a revamped sales force structure, the UK team is energized, focused and accelerating growth. They’re focused on the most critical accounts and optimizing access to these accounts. We expect this positive momentum to continue and contribute to sustained incremental revenue growth as we move forward. Turning to pricing and reimbursement progress, we’re focused on advancing opportunities in other key EU5 markets. In Italy, our dossier is now under review with local health authorities. We are confident that our submission will again deliver a positive clinical assessment and we remain committed to doing all we can with the authorities to lead to a successful price negotiation by the end of the year. In France, with the recent publication of the RESPECT-EPA cardiovascular outcome study of icosapent ethyl, we have key additional data available which will strengthen our clinical dossier. In other European markets we recently secured national pricing and reimbursement in Greece and Portugal, and we look forward to realizing additional revenue contributions from these markets. As we look to the future, the European market represents an important long-term source of growth for VAZKEPA. With IP protection in Europe out to 2039, we stand to realize tremendous value and impact millions of patients for years to come. Moving to Slide 7 in the rest of the world. Overall, the rest of the world represents a number of countries that together provide a sizable market expansion opportunity. Along with our partners, we continue to make regulatory market access and commercial launch progress across key markets, all of which further expands access for patients to VASCEPA/VAZKEPA, reinforces the impact the product has already achieved and enhances cash generation for the future. Specifically looking at Asia, in China, our partner Eddingpharm recently announced that they received regulatory approval for VASCEPA for cardiovascular risk reduction from China’s National Medical Products Administration, or NMPA. Following approval by NMPA, Edding is working to include VASCEPA on the National Reimbursement Drug List, or NRDL, and augment the ongoing commercial launch of VASCEPA in China to include the cardiovascular risk reduction indication. NRDL listing serves as the primary pathway for public reimbursement of pharmaceutical products in China, covering 98% of the Chinese population. Products included in this listing can be readily prescribed from public hospitals in China. This is an important step in advancing access for VASCEPA to patients across China and to making it a key component in the treatment paradigm addressing the growing CBD public health issue in the second most populated country in the world. To that point, according to the World Heart Federation, cardiovascular events such as ischemic heart disease and stroke have been projected to increase by 50% among the population in China between 2010 and 2030. As a reminder, our agreement states that as a result of achieving the cardiovascular risk reduction indication in China, Amarin earned a $15 million milestone payment from Edding, in addition to future commercial milestone payments as well as tiered royalties on sales, a source of sustained cash in the years to come. In Australia, our partner CSL (OTC:CSLLY) Seqirus has now advanced the pricing and reimbursement discussions with local authorities to the final stages. We’re also supporting commercial launch readiness in the market through medical education and sales force readiness initiatives. In Canada, our partner, HLS Therapeutics announced that its entered into a product listing agreement with the Province of Alberta for the listing and public reimbursement of VASCEPA. The PLA with Alberta Health is effective August 1, 2024. In summary, our teams and partners are continuing to advance efforts to get VASCEPA and VAZKEPA into the hands of as many patients as possible globally. We’ve made progress under sometimes difficult market and reimbursement challenges, but as more stakeholders become increasingly educated on the strength of the VASCEPA clinical data and what it means for patient care, our confidence continues to solidify on its long-term value. Now turning to Slide 8 in the U.S. In the second quarter, the U.S. team continued to maintain our IPE market leadership through exclusive accounts representing approximately 50% of the IPE market. Prescription market share remained stable in the U.S. for the 7th consecutive quarter, while revenues in the quarter were impacted primarily by a decline in net selling price due to generic competition. The U.S. business continues to generate cash, funding our efforts globally, particularly in Europe. Our market share strength is a direct result of what the U.S. team has done to work efficiently while maximizing VASCEPA’s value in the U.S., despite last year’s strategic decision to eliminate the sales force and significantly reduce marketing spend given increasing generic competition. While we’re encouraged that the prescription volume has remained stable in the first half of 2024, as we’ve always said, the U.S. market is highly dynamic. We announced during the second quarter that in the second half of 2024, our business will be impacted by the loss of an important contract with a major exclusive commercial account which moved branded VASCEPA to a blocked status on its formulary. This account represents approximately 25% of our business and is expected to reduce our second half 2024 revenues. It is important to keep in mind that while the decision will undoubtedly have a significant impact on overall VASCEPA volume, we believe that branded VASCEPA will continue to be the market leader in the total IPE market even after taking into account the full impact of the loss of this major exclusive plan is absorbed. And importantly, despite the ongoing challenges presented by generic competition in the U.S., remember, we’ve prepared for all scenarios and are ready to change our approach to this business as the market continues to evolve. This includes the launch of an authorized generic at the optimal time, which will be bolstered by our strong supply position. We believe this would help us retain our IPE market leadership as well as generate revenue for years to come. Now I’d like to hand the call over to Tom Reilly to review our second quarter 2024 financial performance. Tom?
Tom Reilly: Thank you, Aaron. Good morning, everyone. Today, I’m reporting details regarding our financial performance in the second quarter of 2024. Turning to Slide 10 in the second quarter of 2024, Amarin reported total net revenue of $67.5 million, which included net product revenue of $47.5 million and $20 million of licensing and royalty revenue versus $80.2 million total revenue in the second quarter of 2023. U.S. product revenue was $43.8 million in the second quarter of 2024 versus $64.6 million in the second quarter of 2023. This decline was driven largely by lower net selling price due to the generic competition in the market. Despite the revenue decline, the U.S. business continues to deliver significant cash. Product revenue also reflects European net product revenue of $3.5 million, a $2.9 million increase over the prior year, driven by revenue growth from both Spain and the UK as well as supply shipments to our partners in Greece and Israel. Licensing and royalty revenue was $20 million in the second quarter of 2024 versus $15 million in the second quarter of 2023. The current quarter amount reflects the contribution of a $15 million milestone related to obtaining cardiovascular risk reduction approval in China and a $4 million of non-cash payment related to change in accounting estimate on a previously received partnership milestone. Cost of goods sold in the second quarter of 2024 was $24.7 million, compared to $37.5 million in the second quarter of 2023. Gross margin in the second quarter of 2024 was 48% and Q2 2023 was 64%, excluding inventory restructuring charges in the second quarter of 2023. This decline is due to a decline in the net selling price in the U.S. Now, moving on to operating expense of the P&L. July 2023, we announced we would reduce our cost basis by $40 million annually. Today, we are pleased to report that we have achieved $50 million in cost savings on an annualized basis. Overall, operating expenses were $43.3 million in the second quarter, comprised of $38.5 million in selling, general and administrative expenses and $4.7 million in research and development expenses, which is approximately a $14 million reduction in operating expenses versus the second quarter 2023, excluding the 2023 restructuring expenses. Turning to profitability. We reported a GAAP net income of $1.5 million for the second quarter of 2024 versus a $17.6 million loss in the prior year period. On an adjusted basis, the company realized a profit of $5.9 million versus $8.6 million in 2023. Now, let me turn to Slide 11 and our efforts and results in controlling costs and effectively managing our cash. As of June 30, 2024, Amarin reported aggregate cash and investments of $307 million. While our cash balance has been impacted by revenue shortfall, we have successfully maintained a stable cash position over the last eight quarters. The sizable cash balance provides an important foundation for the company. We continue to focus on balancing, preserving cash with managing costs and at the same time pursuing channels to expand product revenue. Now, let me provide a brief update on our share repurchase program. As announced in January, Amarin entered into a conditional share repurchase agreement with Cantor Fitzgerald to purchase up to $50 million of Amarin’s ordinary shares. The company announced this program given its confidence in the business and our cash position at that time and the potential to return value to shareholders. In April, we secured shareholder approval and in May, we successfully secured UK High Court approval for the share repurchase program. While we actively assess business and market conditions on an ongoing basis, including the performance of our business, our cash position and other factors, at this time, we have not initiated share repurchases given current conditions. We will continue to assess these conditions moving forward and we would consider initiating share repurchases if and when the business and market conditions improve. With that, I will now turn back to Aaron for closing remarks and to begin the Q&A portion of our call. Aaron?
Aaron Berg: Thanks, Tom, for the overview of financial results and the update on the share repurchase program. As we shared this morning, we believe there’s significant long-term value in VASCEPA/VAZKEPA. Our goal is simple and clear to harness the attributes of the product over 10 years of science and clinical data, including more than 300 publications on VASCEPA and the backing of 30 medical societies around the world recognizing the value of the product and extended IP position in Europe out to 2039 and unmet need globally to reduce cardiovascular risk as cardiovascular disease remains the number one killer around the world, and multiple key untapped markets in Europe and the rest of the world where access can be opened to maximize its value potential at a faster pace. The progress we’ve made to date is not enough. We understand the need to accelerate performance, to realize the potential of the product across Europe and the rest of the world markets with our partners, and to continue to maximize profitability in the U.S. As we continue our operational execution to rapidly build value across global markets. We’re also examining all possibilities and opportunities to unlock the value of this product for more patients. Before we turn to Q&A, I’d like to thank our Amarin colleagues for their continued commitment and dedication. Each of you come to work every day focused on bringing VASCEPA and VAZKEPA to patients, because you know it can make a difference. Thank you all for your efforts. And with that, Mark, let’s begin the Q&A portion of the call.
Mark Marmur: Thank you, Aaron. As we previously shared, to enhance engagement with the company’s shareholder base and facilitate connections with its investors, Amarin has partnered with say technologies to allow retail and institutional shareholders to submit and upvote questions, a selection of which will be answered by Amarin management during today’s earnings call. Let’s begin the Q&A. Aaron, this question is for you. In the U.S., what is our outlook for continued stabilization in VASCEPA U.S. revenues against additional generic competition? And what’s the plan for renewing exclusive contracts for 2025?
Aaron Berg: Yes. Thanks, Mark. And first of all, thanks again to all the investors who submitted these questions. We greatly appreciate it. It’s important to keep in mind that while the loss of the commercial exclusive in the U.S. is certainly significant, we believe that branded VASCEPA will continue to be the market leader after the full impact of the loss of the major exclusive plans absorbed. This recent decision only impacts that single commercial plan under that account. It does not impact Medicare Part D plans. The significant majority of our exclusive volume is in Medicare Part D plans. We do have exclusive IPE status at other commercial plans, but those plans represent a smaller portion of our total volume. Based on the feedback we received from the PBM for those plans, we expect that they will retain exclusive status for the remainder of 2024. Looking at 2025, we submitted what we believe to be competitive offers for 2025, and plans are now in the process of making their decisions regarding formulary coverage to start 2025. The feedback we’ve received to-date regarding our offers has been positive, but it’s far too early to make any predictions regarding 2025 coverage status even at the plans that have given us positive feedback. We also have been preparing and have the ability to launch an authorized generic, if necessary, to maintain our leadership position.
Mark Marmur: Thanks, Aaron. Tom, during today’s call, we provided an update regarding the share repurchase program. Can you share more on the market conditions impacting the decision not to commence share repurchases?
Tom Reilly: Thank you for the question. While we received both shareholder and UK high court approvals in the second quarter, we did not commence any share repurchases in the second quarter due to business and market conditions. We are monitoring the cash generation in the U.S. business over the coming quarters, following the loss of a key commercial exclusive plan, as well as our progress in Europe. As these factors impact our cash position, and the viability of the share repurchase program moving forward.
Mark Marmur: Thanks, Tom. Investors would also like to know if we have an update on a potential delisting from NASDAQ and if we would consider a reverse split to increase the share price.
Tom Reilly: Okay, thanks, Mark. First, on the delisting, given that we traded under $1 for 30 consecutive trading days, we received official notice of a potential delisting from NASDAQ at the end of May. Keep in mind, the full process could take up to 360 days if we continue to trade below $1. However, there are financial levers, strategic and operational opportunities to regain compliance. We believe the operational opportunities are to progress in Europe, advancing efforts with partners in the rest of the world, and delivering cash in the U.S. which all can help us to regain NASDAQ compliance. On a potential reverse stock split, we are always considering the pros and cons of all options to increase shareholder value.
Mark Marmur: Jonathan, we’ve received a number of questions regarding the recent decision by the Federal Circuit to reverse a previous decision in the skinny label litigation. Can you comment on that?
Jonathan Provoost: Sure, Mark. To recap, in November 2020, we filed a patent infringement lawsuit against Hikma, alleging that Hikma activities associated with their marketing and sale of their generic icosapent product induced infringement of patents covering the use of VASCEPA to reduce specified CV risk. In January 2022, the district court dismissed our complaint against Hikma for failure to state a claim. We appeal that decision to the appellate court, and the appellate court heard oral arguments in April of 2024. In late June, the appellate court reversed the district court’s decision, finding that our allegations against Hikma do indeed plasma state a claim or induced infringement. Due to this finding, the case will return to the District Court. While we welcome the Federal Circuit’s decision, this simply means that the case will now proceed within the District Court. No ruling has yet been made on the merits of the allegations we’ve made.
Aaron Berg: Thanks, Jonathan. Steve we recently saw that the respect EPA study was published in circulation. Can you remind our investors about the background of this study and why it is important?
Steven Ketchum: Thanks, Mark for the question. The RESPECT-EPA clinical trial is an independent study funded by the Japanese Heart Foundation. In 2005, the Japan EPA Lipid Intervention study or JELIS first demonstrated a beneficial effect of highly purified eicosapentaenoic acid or EPA on cardiovascular outcomes in patients with or without coronary artery disease also referred to a CAD. In 2019, Amarin published the positive results of its double-blind placebo-controlled study REDUCE-IT in patients with cardiovascular risk and elevated TG levels. And now, RESPECT-EPA is the third study that demonstrated the value of highly purified EPA in reducing cardiovascular outcomes in patients with CAD. The RESPECT-EPA study used 1.8 grams per day of purified EPA, which is consistent with the substantial body of evidence from the REDUCE-IT and JELIS trials, showing that highly purified prescription EPA plus statin significantly reduces the risk of cardiovascular events in high- and very high-risk statin-treated patients. Importantly, the study achieved a borderline statistical significance with a 21.5% reduction in the primary composite endpoint measuring cardiovascular risk with the p value of 0.054 and achieved a statistically significant 26.6% reduction in the secondary composite endpoint of RESPECT-EPA with the p value of 0.03. EPA level also matters. A post-hoc analysis conducted by the investigators to control for attained EPA levels yielded a statistically significant 27.5% reduction in the primary endpoint with the p value of 0.02.
Aaron Berg: Thank you all for those updates. We will now open the Q&A up for additional questions.
Operator: [Operator Instructions] Your first question for today is from Louise Chen with Cantor.
Carvey Leung: Hi. Good morning, everyone. This is Carvey on for Louise from Cantor. Our first question is, with the rise of obesity drugs, has metabolic disease education and marketing been easier with physicians in gaining higher adoption rate for VASCEPA in your target markets? Second, from a growth perspective, which ex-U.S. markets will be the strongest in driving commercial sales. Thank you.
Aaron Berg: Thank you for the question. We appreciate it. So, first of all, regarding the obesity drugs, can you just clarify your question? It was a little bit muffled. Can you clarify that for us?
Carvey Leung: Yes. With obesity drugs, has the conversation with physicians on education and marketing metabolic disease been easier?
Aaron Berg: So are you asking, is it making it easier, the GLP-1s. Are you asking, is it making it easier for us to have conversations about VASCEPA and cardiovascular risk reduction?
Carvey Leung: Yes, the latter. The conversations with them.
Aaron Berg: Yes, I think that. So, first of all, that’s a very good question, because obviously the obesity drugs are. They are tremendous drugs, and what they’ve done for patients is tremendous. They’ve also heightened the awareness of the unmet need and cardiovascular risk reduction. That’s exactly where our sweet spot is. There’s a lot of overlap with the patients. Even with the obesity drugs, a lot of the patients continue to need cardiovascular risk reduction. Part of the challenge with the noise around the GLP-1s a share of voice issue for us, and that’s that we’re not a big company like some of those companies that are marketing those drugs. So we have to be very selective on who we speak with, make sure we identify the patients carefully and be very clear about conveying the strength of the VASCEPA clinical data. But it does open the opportunity and increase the opportunity around cardiovascular risk reduction. And there’s no question that when we get in front of the right customer? When we have the chance to educate? When we at the time show them the wealth of data around VASCEPA and the unmet need, that VASCEPA can, in fact, meet for a number of those patients it benefits us. Regarding the markets that are most important to us as we spoke about, the UK is very important. We focused on the EU5. Right now, we’ve launched the UK first and the EU5. And the changes we’ve made last year, as commented on during the earlier portion of the call, those changes are taking hold and we’re seeing some acceleration. We’re seeing an increase in demand, we’re seeing an increase in the number of patients. We’ve got a long way to go, but we’re pleased with the organization and the drive of the organization. We’re seeing it in the performance and we’re really counting on the UK to accelerate. There’s a lot of potential there. Spain launched more recently and we are very encouraged with what we’ve seen in Spain. There’s tremendous execution. It’s a very focused strategy, focused on the select group of patients that were referenced in the earlier portion of the call, particularly around acute coronary syndrome. They’re focused on 2,500 physicians, primarily specialists, and covering 80% of the market. Spain has also shown that there’s promotion sensitivity that when we have the time to promote VASCEPA/VAZKEPA. As we did in the U.S., physicians respond. And we know over time, if we continue to execute that, we’ll continue to see that growth. And then China is another market we’re very excited about. It’s an enormous market. We have a strong partner there. We just got the cardiovascular risk reduction indication. They are working to get. So in China, Eddingpharm has launched with a very high triglyceride indication initially similar to what we did in the U.S. They now have the cardiovascular risk reduction indication. And the next step is to get on the NRDL, which is the national drug listing that will reimburse for a much broader population. So not only will we have the cardiovascular risk reduction indication, which is essentially, if it’s like the U.S. 10 times the size of the market, a very high triglycerides. But it’ll be reimbursed for so many of those patients nationally as well. We look forward to that toward the end of the year. Edding is working hard to get that listing. And if successful, it’ll be January 1. And we’re expecting significant growth in China going into 2025. So we’ve got some markets and then there are other markets where we’re still seeking reimbursement and we’ll be ready to launch and execute in those markets as well. I hope I answer your questions.
Carvey Leung: Yes. Thank you. Congrats on all the progress.
Aaron Berg: Thank you.
Tom Reilly: Thank you.
Operator: Your next question for today is from Jessica Fye with JPMorgan (NYSE:JPM).
Jessica Fye: Great. Good morning. Thanks for taking my questions. With the several generics launching in the U.S. over the past six months and the impact on net selling price, can you talk about how we should think about U.S. net price in the back half relative to what we saw in the second quarter? And then for Europe, can you speak a little bit more to which country is contributing most to quarterly sequential growth? And also just tell us how much the supply shipments to the partners in Greece and Israel contributed in the quarter? Thank you.
Aaron Berg: Sure. Thank you for the questions and nice to hear from you. I’ll comment on the market dynamics in the U.S., and Tom may want to comment on the impact on net selling price. There were three additional generics that entered the market in Q2. What we haven’t seen is a consistent, we monitor very carefully the pricing, the net cost, the discount that the generics are giving, and we haven’t seen consistent behaviors across the generic category. Nevertheless, of course, we are getting more pressure because we’ve said for years now that it’s a very dynamic market, increasing generic size market, and it’s requiring us to, as we compete on price, to dig deeper on the rebate side. Right now, we’ve been able to maintain our leadership position other than the CVS commercial plan that we lost starting in Q3. So that puts pressure on us. And of course, going into 2025, we expect the rebates to go up as well and give additional pressure, downward pressure on the NSP [ph]. Tom, I don’t know if you want to add any additional color, specifics, NSP.
Tom Reilly: Yes. Sure. Jess, related to second half of the year, we expect to see continued price decline in the second half of the year related to pricing and specifically related to mix as we lost the key commercial plan, our volume would be heavier in Medicare Part D. We expect to see high single digit price decline versus what we saw in the first half. So continuous price decline. And then, Jess, I think your second question was related to the supply shipments related to the Greece – and to Greece and Israel. We don’t give country-by-country revenue, but I can say about 15% to 20% of our total revenue in Europe was related to the supply shipments to those particular countries, which we’re very excited about. We have partners in place and ready to expand in the market in Greece and Israel.
Aaron Berg: And Jess, to the question you raised about the countries, as Tom said, we don’t give specific numbers for each of the countries. But what we could say, as we’ve said is UK, the focus is on the EU5, the two – those – the two countries that we’ve launched out of the EU5, UK and Spain, we’re seeing more growth. We have a long way to go. We just started in Spain, but are very encouraged. We announced Portugal, which will complement what we’re seeing in Iberia and then UK, the changes we’ve made, the way the team is executing we expect growth as well. We know both markets have significant potential.
Jessica Fye: Great. Are there other countries we should anticipate seeing reimbursement come online in 2024?
Aaron Berg: Well, our hope is we’re working closely with the authorities in Italy and we’re hopeful that we can find that win-win with the reimbursement authorities. And if so then our hope would be by the end of the year. We’d see that in Italy. France, we have we’re at the stage where respect EPA should be very helpful in bolstering our clinical dossier, and that’ll allow us to ramp up the reimbursement discussions there as well. But we don’t expect that in 2024.
Jessica Fye: Thank you.
Aaron Berg: Thank you.
Operator: The next question for today is from Paul Choi with Goldman Sachs (NYSE:GS).
Paul Choi: Hi. Good morning, Aaron. Good morning, Tom. Thank you for taking our questions. My first question relates to China, and can you maybe comment on when your partner there expects potential inclusion in the NRDL? Would it be permissible for 2025 or should we anticipate 2026? My second question is, this quarter you benefited from the one time milestone for the CV risk reduction, which let you guys be operating breakeven, but without that I think you would have been at a loss. So my question there is, given that one time milestone, as well as the formulary loss with regard to CV’s anthem. Can you maybe just comment on what is the OpEx flexibility there? And is the aim to remain breakeven from an enterprise perspective, or will you continue to spend in the back half of the year supporting the ex-U.S. launch? Thank you.
Aaron Berg: Thanks, Paul. So regarding NRDL, because of when the cardiovascular risk reduction indication was granted, which was before the end of June, it’s very possible that VASCEPA is on the NRDL for January 1st, 2025. There are a number of steps that that we need to go through, Edding needs to go through, but that would be hopeful and of course, that would be significant. Tom, do you want to comment on the milestone in OpEx?
Tom Reilly: Sure. Thanks for the question, Paul, good to hear from you. And you’re correct. We were benefited from a 15 million milestone receipt from adding the cardiovascular risk reduction. And with that we also had a change in accounting estimate related to $4 million of deferred revenue that we recognized in the quarter as well from revenue recognition. So your math is correct, related to our plans. Our plans are to continue to invest in expanding into Europe with the levels and depending on pricing and reimbursement decisions that are upcoming. We do expect a slight declining cash for the next couple quarters, right. Given the fact that we’re continuing to invest into Europe at this point in time, you probably saw from our announcement we have been very prudent on cash. We’ve maintained cash over the last eight quarters. We have looked at our operating expense base. We reduced 50 million annually on an annualized basis. So we’re going to continue to monitor our operating expenses and to invest prudently. But we do expect somewhat of a decline remainder of the year.
Paul Choi: Okay, got it. Thank you very much.
Operator: Your next question is from Roanna Ruiz with Leerink. Roanna, your line is live. Roanna, if you’re on mute, please unmute it. We’re unable to hear you.
Unidentified Analyst: Hi. Hi, Aaron. Sorry, this is Maisie on for honorary. Thanks for taking the question. Given the recent approval of the cardiovascular risk reduction indication for VASCEPA by the NMPA in China, could you please elaborate on what you think that market opportunity looks like in China? And kind of just what are the exact next steps that ending would need to take to launch commercially?
Aaron Berg: So, well they’ve already launched. First of all, the opportunity for cardiovascular risk reduction is around $300 million for the total market. In terms of VASCEPA numbers in terms of which – what the size of the population that meets the label criteria, I’m not sure offhand, but certainly, of course, a subset of that is to say, it’s a very large market. Edding has already launched with a very high triglyceride indication. But what they’ll be able to do is so they have about 100 reps, they’ll focus on about 300 hospitals. And then once it’s on NRDL, then they’ll see how the progress is and make decisions, prudent decisions, as to how they can expand. And, again hopefully NRDL is January 1. And even between now and January 1, because of the cardiovascular risk reduction indication, perhaps they’ll see the trajectory ramp up, as we did in the U.S., and they’ll be able to make decisions on expansion even prior to NRDL. But I’ll leave it to them. They’re closer to the market. Tom, do you want to. I know you’re close to it as well. Why don’t you comment?
Tom Reilly: Yes. Now, I’d just like to add to that, Aaron, so as you mentioned population of 300 million eligible patients under the label. In addition, just keep in mind the economics – with China. With our partner, tiered royalty structure, no cost infrastructure that we have, and then subject to sales milestones. We’re very excited about the overall opportunity. Economics in favor as Aaron mentioned earlier, with our partner, we have a very good partner in China to support us.
Aaron Berg: And just for all of our partners, now that we have a number of partners, we work very closely with them to help them succeed. We have wealth of experience over a decade commercializing it, not to mention all the other regulatory and clinical and medical affairs side. Everything that we can share with them, we work closely to help them succeed and we look forward to a number of them. But of course, given the size of China, that’s significant and we’re excited about that.
Unidentified Analyst: Great. Thanks. Just one follow up, Aaron is how should we also think about the sales force increase in like regional personnel as you guys start to ramp up more in the European markets?
Aaron Berg: So we’ve been very judicious about first it comes down to the reimbursement side and the patient criteria and then the analytics around who we target. So we’re starting, as I mentioned in the earlier portion of our comments, we’re focused on, there’s a big focus on the ACS patients. That’s a patient population that are readily identifiable. They clearly have unmet need. They see the physicians more often. They’re more inclined to get combination therapy. More inclined to need combination therapy beyond just standard of care. So it’s a real opportunity and it also allows us to focus on cardiologists or specialists, depending on the market. So based on when we launch in each of the markets, it depends on how we get started and then expand from there. So there are a lot of variables. Every country is different, but will get started with a more specialty approach. We’re doing that, for example, in Spain and the UK. We’re very efficient in our focus. Once we get a foothold, those patients tend to go back to the GP audiences and then that’ll be time for us to expand. So that’s how we think about it. As a smaller company, we try to be very prudent about our investment and get traction first, but it’s a balance with getting the opportunity and accelerated lift as soon as we have the opportunity to launch. I hope that makes sense.
Unidentified Analyst: Yes. No, that clearly answered the question. Thank you for your time.
Aaron Berg: Thank you.
Operator: [Operator Instructions] We have reached the end of the question-and-answer session, and I will now turn the call over to Aaron for closing remarks.
Aaron Berg: Thank you, Holly. Appreciate it. And thanks to everybody for your continued interest in Amarin. We greatly appreciate it. Thank you for your questions. Thanks for taking the time today. We hope it was helpful, and everyone has a good day. Thank you.
Operator: This concludes today’s conference, and you may disconnect your lines at this time. Thank you for your participation.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.