AMARIN-PLC Earningcall Transcript Of Q2 of 2024
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 D. Berg -- President and Chief Executive Officer 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 No. 1 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 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 -- Chief Financial Officer 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 D. Berg -- President and Chief Executive Officer 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 No. 1 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 -- Vice President, Corporate Communications and Investor Relations 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 D. Berg -- President and Chief Executive Officer 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 -- Vice President, Corporate Communications and Investor Relations 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 -- Chief Financial Officer 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 -- Vice President, Corporate Communications and Investor Relations 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 -- Chief Financial Officer OK. 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 -- Vice President, Corporate Communications and Investor Relations 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 -- Chief Legal and Compliance Officer 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 D. Berg -- President and Chief Executive Officer 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 B. Ketchum -- Chief Scientific Officer and President of Research and Development 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 D. Berg -- President and Chief Executive Officer Thank you all for those updates. We will now open the Q&A up for additional questions. Operator Questions & Answers: |
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