Yahoo Finance Amarin Corporation plc (NASDAQ:AMRN) Q1 2024 Earnings Call Transcript
Amarin Corporation plc (NASDAQ:AMRN) Q1 2024 Earnings Call Transcript May 1, 2024
Amarin Corporation plc misses on earnings expectations. Reported EPS is $-0.01 EPS, expectations were $-0.0075. AMRN isn't one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).
Operator: Good day, and welcome to Amarin Corporation's Conference Call to discuss its First Quarter 2024 Financial Results and Business Update. I would now like to turn the conference over to Mark Marmur, Vice President, Corporate Communications and Investor Relations at Amarin. Please go ahead.
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 March 31, 2024, which has been filed with the SEC and is available through the Investor 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. Patrick Holt, Amarin's President and Chief Executive Officer, will provide a brief overview of our first quarter 2024 business update; Jonathan Provoost, Amarin's Chief Legal and Compliance Officer, will provide an intellectual property and legal update, Steve Ketchum, Amarin's President of R&D and Chief Scientific Officer, will provide an update on key data presented at ACC.24; and Tom Reilly, Amarin's Chief Financial Officer, provide a review of our first quarter 2021 financial results.
Following prepared remarks, we will open the call to your questions. I will now turn the call over to Patrick Holt, President and Chief Executive Officer of Amarin. Pat?
Patrick Holt: Thank you, Mark. Good morning, everyone, and thank you for joining us today. Turning to Slide 5. Look, every day, our team in Amarin is focused on making progress to enhance the value of our business and maximize the patient uptake of a VASCEPA and VAZKEPA. We firmly believe this focus is the best plan forward for Amarin and it will strongly position us for the future. In Q1, our team continued to deliver considerable progress. So turning to our business highlights first. In the first quarter, we were successful in both defending and extending our IP position in Europe. This effort delivered an extended IP runway in Europe until 2039. This is really important as it enhances the value of our business considerably.
Jonathan will provide more details in this achievement later in the call. From a commercial perspective, in Europe, our teams delivered approximately 65% in-market sales growth in Q1 2024 versus Q4 2023 led by Spain and United Kingdom. On the pricing and reimbursement front in Europe, we've resubmitted our dossier in Italy. In France, plans remain on track to submit our strength in dossier in 2024. And in Germany, continued work is being done for a potential resubmission. Additionally, we remain on track to secure pricing reimbursement in five additional markets in 2024 in Europe. We expect to share pricing and reimbursement outcomes in Greece and Portugal in the near future. Our team continues to focus on prudent spending and our cash position.
We ended the first quarter with a cash position of $308 million, marking a stable cash position over 7 quarters. Importantly, we also secured shareholder approval for our share repurchase program of up to $50 million. Our next step is to secure U.K. High Court approval and the share repurchases are anticipated to begin in the second quarter. So let's now dive into each of our business areas and the performance in the first quarter. Turning to Slide 6 and more specifically to Europe, before we get into the results for the quarter, let me reiterate an important point that drives our confidence in the opportunity across Europe. Underpinning our progress in our path forward in Europe is our intellectual property position for VAZKEPA, which is now being extended into 2039.
This provides additional value for both patients and our company. So turning to the first quarter’s commercial progress in Europe, in Spain, our team is delivering robust launch growth, and this market continues to prove the value of VAZKEPA for the region and frankly, globally and the new approach we have taken to the region following new leadership changes last year. As of the end of the first quarter, the number of patients on VAZKEPA therapy in Spain has increased 91% in quarter one 2024 versus quarter four 2023. The team continues to focus on HCPs who are early adopters of cardiovascular products. In the United Kingdom, our team is to execute against a more focused strategy and has new leadership in the form of a new country manager in place.
At the end of the first quarter, the number of patients on VAZKEPA therapy in the UK has increased 28% in Q1 2024 versus Q4 2023. Turning to pricing and reimbursement progress, we have strengthened focus on advancing our opportunities in key EU-5 markets. In Italy, we resubmitted our dossier, and we are advancing this process with the authorities to potentially achieve market access for VAZKEPA by the end of 2024. In France, plans remain on track to submit our strength in dossier in 2024. And in Germany, continued work is being done on plans for a potential resubmission. We will continue to communicate progress on France and Germany as additional steps are achieved. In addition, we are pleased to share today that we are well on track to reach our goal of securing positive pricing reimbursement dots decisions in at least five additional markets in 2024.
We expect to share news on pricing reimbursement outcomes in Greece and Portugal in the near future. Turning now to the United States, in the first quarter, the team maintained IPE market leadership. We have retained exclusive accounts representing more than 50% of the IPE market. Market share has remained stable in the U.S. for the sixth consecutive quarter. These results are a testament to the work our managed care, trade and medical affairs teams have done to extend VASCEPA's life cycle despite the elimination of our sales force and reduce marketing spend. While we are encouraged to start the year in a solid managed care position, the market remains highly dynamic. Whilst our revenues in the quarter were impacted primarily by a decline in net selling price due to generic competition, the U.S. business remains highly profitable funding our efforts in Europe.
Our U.S. team is skilled at analyzing market dynamics, and we are prepared to change our approach to this business as the market continues to develop, including the potential future launch of an authorized generic which would be bolstered by our strong supply position in order to retain IPE market leadership. Moving to Slide 8, in the rest of world, Amarin and its partners continue to make regulatory market access and commercial launch progress across key markets. In China, the second largest cardiovascular market globally by population, Amarin’s partner Edding, continues to launch VASCEPA for very high triglycerides with a focused strategy. In the first quarter of 2024, Edding delivered a 100% increase in sales growth versus the fourth quarter of 2023.
The NMPA review of the cardiovascular risk reduction indication remains on track and as a reminder, an approval for this indication would open up the potential of National Reimbursement and drug listing or NRDL. In Canada, HLS continues to make important progress across the market. In British Columbia, HLS recently secured public access and listing with the leading private payor Pacific Blue Cross for VASCEPA. And in Australia, Amarin’s partner CSL Seqirus continues to advance the submission for VAZKEPA reimbursement with local health authorities and timelines for potential reimbursement remain on-track. In summary, our teams and our partners have made significant progress in the first quarter across the business, advancing momentum needed for Amarin.
Like all biopharmaceutical companies, intellectual property is a foundational element of our business and our ability to provide our product to patients. I would now like to turn the call over to Jonathan Provoost, to provide more detail on our IP extension for VAZKEPA in Europe. Jonathan?
Jonathan Provoost: Thank you, Pat. Good morning, everyone, and thank you for the opportunity to give a brief update on our IP progress for VAZKEPA. Turning to Slide 10. As we announced in April, we have been successful over the past few months, taking important steps to strengthen our intellectual property position for VAZKEPA in Europe. Before I go into the details, it is important to understand two key items. First, that Amarin's intellectual property for VAZKEPA in this region is built upon a multilayered collection patent and regulatory protection such that exclusivity for VAZKEPA stems from a diverse portfolio of intellectual property assets. And second, the recent progress we have made extends commercial exclusivity for VAZKEPA until 2039, eight years beyond the data exclusivity period of 2031.
In our announcement in April, we shared that we were successful with two separate patent outcomes. First, we were recently successful in defending a European VAZKEPA patent from third-party opposition within the European Patent Office or EPO. That patent expires in 2033. Following this decision, the company received a decision to grant from the EPO for a new patent covering VAZKEPA that extends the product exclusivity until April 2039. In addition to these patents, Amarin possesses additional European patents and pending patent applications that further our intellectual property protection for VAZKEPA within the European market. Taken together, these patents collectively provide us with a high level of confidence that our intellectual property position for VAZKEPA in Europe is strong and dependent, providing us exclusivity protection in Europe into the 2039 period.
As was stated earlier, intellectual property is a foundational element of our business and our ability to provide our product to patients. As we've done in the past, Amarin will continue to vigorously defend our intellectual property to the fullest extent possible. As we know, the data and science behind VASCEPA and VAZKEPA is critical to its commercial success in markets around the world. I would now like to turn the call over to Steve Ketchum to provide an overview of key data presented at the ACC.24 Conference. Steve?
Steve Ketchum: Thank you, Jonathan. Good morning, everyone, and thank you for the opportunity to summarize key data on VASCEPA/VAZKEPA and EPA recently presented at the American College of Cardiology's Annual Scientific session. Turning to Slide 12. In early April, the American College of Cardiology held its annual scientific sessions in Atlanta, Georgia. The Congress brought together more than 17,000 attendees surpassing pre-COVID attendance levels. Data featured at ACC.24 included key abstracts on REDUCE-IT subpopulations as well as mechanistic activity data on EPA. The first abstract was a post-hoc analysis of REDUCE-IT that sought to measure VASCEPA/VAZKEPA's effect on the relationship between lipoprotein(a), also known as Lp(a) levels and reducing MACE.
High Lp(a) concentrations are associated with increased CV event risk even when low-density lipoprotein cholesterol, or LDL-C levels are well managed. There are no treatments currently approved to reduce residual CV risk on top of contemporary medical therapy in patients with high Lp(a) levels. In this analysis of REDUCE-IT, VASCEPA/VAZKEPA showed a clear clinical benefit for patients with both high and low baseline Lp(a) levels. The molecule provided a relative risk reduction of 21% among patients with the high Lp(a) level of greater than or equal to 15 milligrams per deciliter at baseline and a relative risk reduction of 25% and among patients with a low Lp(a) level of less than 50 milligrams per deciliter at baseline. These findings, which were published simultaneously in the Journal of the American College of Cardiology, reinforce VASCEPA/VAZKEPA’s clinical benefit in these at-risk patients’ sub-patients.
In a second abstract featured at ACC, Investigators explored REDUCE-IT data to determine if VASCEPA/VAZKEPA reduces CV events among high-risk CV patients irrespective of baseline LDL-C. Elevated LDL-C is a well-established major CV risk factor, supported by clinical evidence showing decreased atherosclerotic disease events when LDL-C is therapeutically lowered. Findings from this analysis showed that among adults with increased CV risk and elevated triglycerides, icosapent ethyl clearly reduced the rate of CD outcomes irrespective of baseline LDL-C including in those with very well controlled LDL-C of less than 55 milligrams per deciliter. And finally, a few comments on EPA mechanistic data that were presented at the Congress which provide new insight of action for VASCEPA/VAZKEPA, including the effect of EPA in combination with high-intensity statin on endothelial cell function during inflammation and EPA effect on Lp(a) levels.
This latest research reaffirms Amarin’s commitment to advancing cardiovascular care and helps further advance the medical community’s understanding of the role, the value and the potential mechanism of action of VASCEPA/VAZKEPA to reduce cardiovascular events in at-risk patients globally. Before I close, on behalf of the Amarin team, I would like to thank the investigators for their important work on the analyses featured at ACC. It is through their efforts that we are able to continue to better understand the science behind VASCEPA/VAZKEPA. Now, I would like to hand the call over to Tom Reilly to review our first quarter 2024 financial performance. Tom?
Tom Reilly: Thank you, Steve. Good morning, everyone. Today, I am reporting details on our financial performance for the first quarter of 2024. In the first quarter of 2024, Amarin reported total net revenue of $56.5 million, including net product revenue of $55.2 million and $1.4 million of licensing and royalty revenue versus $86 million total revenue in the first quarter of 2023. U.S. product revenue was $48.1 million in the first quarter of 2024 versus $82.3 million in the first quarter of 2023. This decline was driven largely by net selling price impact due to the generic competition in the market. Despite the revenue decline, the U.S. business continues to deliver significant profit. Revenue results include European net product revenue of $1.9 million, a 35% increase versus the fourth quarter of 2023, reflecting growth in revenue primarily from Spain and the United Kingdom.
We recognized $5.2 million in Rest of World revenue in the first quarter of 2024 including product revenue related to supply shipments to our partners in Canada, China and the Middle East. Cost of goods sold in the first quarter of 2024 was $24.6 million, compared to $38 million in the first quarter of 2023. Amarin's overall gross margin on net product revenue in the first quarter of 2024 and 2023 was 55%. Excluding inventory restructuring charges in the first quarter 2023, gross margin was 70%. Moving on to operating expenses. Operating expenses were $45.5 million in the first quarter, comprised of $39.9 million in selling, general and administrative expenses and $5.6 million in research and development expenses, which is a $20 million reduction versus Q1 2023.
We are on track to deliver $40 million reduction in operating expenses by July 2024, which we announced in Q3 2023. Amarin reported a net loss of $10 million for the first quarter 2024, basic and diluted loss per share of $0.02. Let me now turn to our efforts and results in controlling costs and effectively managing our cash. As of March 31, 2024, Amarin reported aggregate cash and investments of $308 million, while our cash balance has been impacted by revenue shortfall over the last several quarters. We remain focused on preserving cash and have maintained a stable cash position over the last seven quarters. The team continues to focus on cash preservation currently investing in right opportunities, particularly in Europe based on pricing and reimbursement decisions.
Before I wrap up, I will 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 ordinary shares. On April 18, Amarin announced we secured shareholder approval for the program. The next step in this process is to seek UK High Court approval. And last week, we filed our claim for approval with the court. Expected share repurchases would commence shortly after the court approval, which we expect in the second quarter of 2024. With that, I will now turn back to Pat for closing remarks and to begin the Q&A portion of our call. Pat?
Patrick Holt: Thank you, Tom, for the overview of our financial results and update on our share repurchase program. Our team continues to remain focused on advancing goals across Amarin. In the first quarter of 2024, we delivered an enhanced European IP position, European growth led by the United Kingdom and Spain, stable cash position of $308 million and advanced our share repurchase program. Our fundamentals continue to provide the foundation for our progress. Best-in-class science supporting VASCEPA and VAZKEPA, a large global opportunity to impact cardiovascular patients, a team dedicated to driving results and a strong balance sheet. Before we turn to Q&A, I’d like to thank our colleagues for their ongoing commitment and dedication. I look forward to continuing to advancing our priorities in order to deliver shareholder value together. And with that, Mark, let’s begin the Q&A portion of the call.
A - Mark Marmur: Thank you, Pat. As we previously shared, to enhance engagement with the company’s shareholder base and facilitate connections with its investors, Amarin is partnering 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. Pat, we received a question from an investor regarding, when can we expect to see revenue from China.
Patrick Holt: Thanks very much for the question. Firstly, it’s important to remember that China is a really large market with substantial unmet needs. In fact, it’s the second largest cardiovascular market globally by population and quite frankly, it’s a market that I’m particularly bullish about. In China, our partner Edding launched VASCEPA for very high triglycerides in Q3 2023, and in this quarter, quarter one 2024, they delivered 100% sales growth versus Q4 2023. In addition, cardiovascular risk reduction, which has been submitted and has been accepted by the NMPA, would open the potential for the national drug and reimbursement listing National Reimbursement Drug List or NRDL, which would therefore increase royalties to Amarin over time.
As a reminder of our deal, the structure of our agreement provides us immediate profitability tiered double digit royalty payments on net sales, as well as development, regulatory and revenue based milestone payments. The cardiovascular risk reduction filing remains on track.
Mark Marmur: Thanks, Pat. Our second set of questions focuses on the share buyback program. What can you tell us on progress? When can we expect the UK High Court will approve it? When will the purchase begin and when will it become completed? Finally, in addition, how much does the company plan to purchase?
Patrick Holt: This is progressing well, and it’s really aligned to our view of the business and the needs that business has. So firstly, we’ve achieved a very critical step, which is shareholder approval. At our recent AGM, shareholders approved a share repurchase program overwhelmingly with 91% approval. We sincerely appreciate the support and engagement from our shareholders on this. The next step is to secure approval from the UK High Court for the program. Last week, we filed a claim for approval with the UK High Court. Importantly, commencement of share repurchases will follow UK High Court approval and will be conducted based on SEC and UK corporate law. Broadly, we continue to believe this is a prudent use of capital to deliver value back to shareholders, given our cash position. We continue to show strong balance sheet with $308 million in cash stable over seven quarters and no debt.
Mark Marmur: Thanks, Pat. Turning to EU-UK sales. Why is Amarin struggled with UK and EU product adoption? What are the main strategic issues and your confidence in addressing them?
Patrick Holt: Thanks very much for the question. Well, firstly, I am confident about our progress in Europe. And as we’ve noted previously, in Europe, the process for reimbursement pricing and launch is both complicated and it varies country by country. It’s important to remember that last year, we installed new leadership across the region with a new strategy for Europe. That had some really key focus areas. Firstly, targeted patient and customer segmentation at launch focusing on the highest risk patients, where the urgency to treat is the highest. Secondly, really prioritizing and optimizing our resource, aggressively focused on where we see the near-term significant opportunities. And thirdly, enhancing and being flexible with our value proposition to address specific country payer needs.
While we would all like to see faster update we're encouraged by the progress in making in Europe with 35% revenue growth and 65% in market sales growth in quarter one versus quarter four 2023. At a country level, we can see that our new strategy is working, albeit at a different pace aligned to each market dynamic. Specifically in Spain, this is really an excellent case study demonstrating the value of VASCEPA in Spain as well as across the region, and we're seeing a fast uptake. 91% increase in patients on therapy in quarter one, 2024 versus quarter four 2023. In the UK, we are also seeing our new strategy work, albeit in a slower uptake market. With the team focused on building momentum in key accounts, we see a 28% increase in patients on therapy in quarter one, 2024 versus quarter four 2023.
Again, taking a step back, underpinning all of this, looking at our long term, we've successfully secured additional patent protection out into 2039, which really gives us the confidence to invest and our belief around the future uptake, which enhances the value of our business.
Mark Marmur: Thanks, Pat. Investors would like to know the long-term future of the company. What can you tell us about this?
Patrick Holt: Yes. Great question. And actually a question that both management and the Board are really discussing often and remain incredibly focused on building value for shareholders. So firstly, in Europe, we continue to really focus and see growth in our key EU5 markets, especially the UK and Spain, and we're on track to deliver positive pricing reimbursement in at least five additional markets in 2024. That's underpinned by the confidence of our intellectual property for VASCEPA extending to 2039, which adds value to the company and for patients. In the U.S., it's all about driving profitability. And then in Rest of World with our partners progressing regulatory market access, commercial launches to advance our success. Additionally, we've taken critical steps to reduce operating expenses, which aids profitability and our cash position. All of this strengthens Amarin for today as well as for the future.
Mark Marmur: Make sense. One final question. We saw the Amarin issued a press release regarding healthy women's citizens petition regarding fibrates in the U.S. Can you tell us a bit more about that and why Amarin has weighed in on this issue?
Patrick Holt: Yes. Thanks very much. That's a great question. Look, fundamentally, this is all about patient care and ensuring that patients are being prescribed proven, effective therapies that will reduce their cardiovascular risk. Specifically to fibrates, fibrates are an old class of drugs studied over many years and through a number of clinical studies, most recently the prominent trial, they do not reduce cardiovascular risk when prescribed in combination with statins. Unfortunately, this clinical evidence has not translated to a significant change in prescribing for many patients. It is estimated that in the United States, more than one million patients are being prescribed by fibrates and a statin together comfortably [ph] to reduce cardiovascular risk.
This means that more than 1 million patients are being treated with a combination of products that has no benefit in reducing cardiovascular risk [ph] and that is why we have continued to come out strongly in support of this issue. We will be filing additional comments to the docket on the Citizen’s Petition during the current open comment period. Before we take additional questions, I’d like to thank those shareholders who submitted questions via the Say Technologies platform. We are committed to continuing open and transparent dialogue with our shareholders and the Say Technologies platform is one of the ways that we’re trying to increase shareholder engagement and a two-way dialogue with you all. We look forward to continuing to hear from you and answering your questions on this platform and other opportunities as we move forward.
Mark Marmur: Thank you for those updates, Pat. We’ll now open the Q&A up for additional questions.
Operator: Thank you. At this time, we will be conducting our live Q&A session. [Operator Instructions] Thank you. Our first question is coming from Roanna Ruiz with Leerink Partners. Your line is live.
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