Amarin Corporation PLC

NASDAQ:AMRN

Earnings Call Transcript 2024-Q3

[Operator]

Welcome to Amarin Corporation's conference call to discuss its third quarter 2024 business update and financial results.

I would like to turn the conference call over to Mark Marmur, Vice President, Corporate Communications and Investor Relations at Amarin.

[Mark Marmur, executive]

Good afternoon, everyone, and thank you for joining us. Turning to Slide 2 and our forward-looking statements. Please be aware that this conference call will contain forward-looking statements that are intended to be covered under the safe harbor provided under federal securities law. We may not achieve our goals, carry out our plans or intentions or meet the expectations disclosed in our forward-looking statements. Actual results or events could differ materially, so you should not place undue reliance on these statements. 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 September 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 Slide 3 in today's agenda. Aaron Berg, Amarin's President and Chief Executive Officer, will provide an update on the state of the Amarin business; Pete Fishman, Amarin's Vice president and Global Controller and currently overseeing all finance-related matters for the business, will review our third 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, executive]

Thanks, Mark. Good afternoon, everyone, and thanks for joining us today. In my first full quarter as the President and CEO, I spent time with our teams both in the U.S. and Europe as well as valuable time with many of our partners and scientific experts from around the world. My aim has been straightforward, to determine our path forward and execute the best strategies to drive access to and use of VASCEPA/VAZKEPA for the millions of at-risk patients across the globe.

What I've known for years from the U.S. experience with VASCEPA was confirmed by those stakeholders I've heard from in Europe and around the world. VAZKEPA has the potential for significant growth, value and impact globally that remains substantially untapped.

These dynamics create a tremendous opportunity, one that directly addresses cardiovascular risk worldwide and it's our obligation to patients, providers and payers as well as to shareholders to accelerate access to and use of this tremendous product. While our team has been working very hard and has made progress, this progress has not been enough. We're still in the early stages of launch in many regions around the world with a long runway and there remains much more to do to maximize the value we know is inherent in the global VASCEPA and VAZKEPA franchise. This is based on the need, the science and the impact this product can bring for patients.

Let me start with the most critical component of all, the global unmet need to reduce cardiovascular disease. Despite more than 4 decades of progress in cardiovascular medicine, cardiovascular disease remains the #1 killer globally. In 2021, roughly 20 million deaths were estimated for cardiovascular disease globally, which amounted to an increase of almost 22% from the prior decade.

It's astonishing that with even all the therapeutic innovation and progress we've made, this disease remains such a burden for patients, families, health care professionals and systems globally. As a result, the reduction of cardiovascular events remains a top priority for health care providers, patients, caretakers and payers, public and private.

While LDL cholesterol is the primary target of lipid therapy, reduction of LDL isn't enough. More can and should be done to help patients reduce the risk of cardiovascular events through expanded access to existing and future treatment options that have been proven to reduce that risk, namely products like VASCEPA and VAZKEPA.

Just in Europe alone, there are more than 6 million at-risk patients who are eligible for VAZKEPA based on the approved label. And this does not include the millions of patients in Europe and around the world treated with triglyceride-lowering fibrates and omega-3 mixture products for patients being improperly used these drugs to treat cardiovascular risk.

Even though these products may impact biomarkers, the large, well-controlled cardiovascular outcome trials with tens of thousands of patients have failed to demonstrate a reduction in cardiovascular events. Changing lipid biomarkers is no longer enough and can create a false sense of security for providers and patients alike. Many of these patients need to be on a treatment proven to reduce cardiovascular events. Doing more for many of these patients should include the use of VAZKEPA. And this is not just our opinion.

When we look at VASCEPA and VAZKEPA, it's a proven product backed by science and strong support across the global medical community. Over the last 10 years, more than 300 scientific publications have been generated confirming the unique attributes of VASCEPA and VAZKEPA anchored by the landmark REDUCE-IT trial and confirming that VASCEPA and VAZKEPA in combination with the statin provides an important option for patients globally who need to further reduce their risk of a cardiovascular event.

As a result, this science has been recognized by the global medical community, evidenced by the more than 50 leading medical societies across 20 countries that have issued guidelines and scientific statements supporting the therapeutic value of icosapent ethyl to address cardiovascular risk.

In addition, thousands of scientific leaders and prescribers as well as numerous payer and reimbursement authorities around the world support the product. And the scientific community continues to build on the existing science by conducting and publishing further studies and analyses of its utility in certain at-risk subpopulations and continued ongoing work to further elucidate the mechanism of action.

We also know that this product has significant value and a long runway for growth, particularly in Europe, with recently granted IP out to 2039. Our confidence is evidenced by the experience we've had with the product over the last 5 years in the U.S. since the FDA approval of the cardiovascular risk reduction indication.

In the U.S., following the readout of the REDUCE-IT trial, the reception was remarkable for this product by the scientific community and the potential to positively impact millions of patients with VASCEPA. The REDUCE-IT data generated incredible demand for VASCEPA. Prescriptions increased significantly and product revenue rose substantially.

We witnessed a greater than 50% increase in the number of prescribers totaling 200,000 in the U.S., resulting in more than 80% growth in new prescriptions in the first year post publication of REDUCE-IT. This history of uptake and market response provides evidence that with time to promote and educate and supported by outstanding execution, providers respond favorably to VASCEPA as a therapy that can benefit their patients.

If we apply that experience and learnings from the U.S. to Europe, we know VAZKEPA has the potential to grow substantially with a large eligible patient population based on the approved label and the extended runway out to 2039. We know we're still in the early days of this opportunity in Europe. Our teams in many markets in Europe are just now beginning the education process and we have only scratched the surface of our pricing and reimbursement and launch progress in many markets.

To date, we've unlocked access and launched in 8 European countries, but this only represents about half the market access opportunity in Europe. We've learned that launching in Europe takes time and there remains significant potential to further expand access to VAZKEPA for at-risk patients in a number of additional European countries.

The same holds true for many markets in the rest of the world and we've been opportunistic in many of these markets. We currently have 9 partners who we're collaborating with across a number of markets and we're in the early stages of obtaining reimbursement and launching in some of these important regions. As for the U.S., the company benefits from continued cash generation from the brand tail as we continue to focus on extracting maximum value. The cash generated from our U.S. sales continues to support operations for the company.

In summary, the combination of the current unmet need for patients, the strength and extent of scientific community support of clinical data, extended runway in Europe and the opportunity for expanded access as well as the proven uptake and clear impact on reducing cardiovascular risk around the world translate into a growth and value opportunity for VASCEPA/VAZKEPA that we remain laser-focused on further expanding every single day.

And to that end, our focus is clear: to prioritize execution and performance while urgently evaluating all opportunities to expand the impact of VAZKEPA to millions of patients worldwide. That's our commitment to patients, providers, payers and of course, to shareholders.

Now let me turn to some of the operational highlights our team has delivered in the third quarter and year-to-date. Turning to Slide 6. Our recent progress provides yet further evidence that the value and opportunity of VASCEPA/VAZKEPA is being recognized and validated. In Europe, our focus has been on accelerating revenue in key launch markets while advancing pricing and reimbursement processes. Earlier this year, as mentioned, our team successfully advanced our intellectual property position in Europe, extending our IP for VAZKEPA through 2039. This is important as it extends the runway to realize the true value of this product for patients in Europe.

On the commercialization front, while our revenues continue to grow, powered by continued sales growth in the U.K., Spain and in Central and Eastern Europe markets, we're in the early stages and know we must accelerate growth where VAZKEPA has been launched. We've also continued to advance our pricing and reimbursement efforts to extend access to VAZKEPA for more patients across Europe.

Year-to-date, we have now secured pricing and reimbursement in Greece and Portugal. And in Italy, our team has continued to take steps with pricing and reimbursement authorities and we hope to be in a position to share news soon in this key market.

Turning to the U.S. Our team remains focused on retaining icosapent ethyl market leadership for VASCEPA and extracting as much value as possible for this business despite additional generic competition and pricing challenges. Through the first 3 quarters of the year, VASCEPA has maintained a leadership position with greater than 50% share of the IPE market.

We continue to follow the competitive landscape as well as reimbursement and pricing dynamics and we'll continue efforts to maintain a leadership position.

As an important reminder, we've been sustaining a high level of market share capture with VASCEPA following the shift to a generic market in 2020, a noteworthy track record due to the unique attributes of this product. The U.S. market remains the main source of revenue for the company and currently the primary funding source in support of our expansion plans. And of course, we also continue to assess the optimal time to launch an authorized generic into the U.S. market. Across the rest of the world, our focus has been to extend access to VASCEPA/VAZKEPA through partnerships, growing the sustainable opportunity across these markets.

We're making important progress in this effort through pricing and reimbursement processes and commercialization with our partners. Let me touch on 2 examples. In Australia, our partner, CSL Seqirus, secured Australia's pharmaceutical benefit scheme price listing for VAZKEPA, unlocking public access to the product for patients in that market.

CSL is now launching VAZKEPA and we expect to realize the impact of such partnership-based sales beginning in 2025. And in China, through the first 9 months of 2024, our partner, Eddingpharm, received regulatory approval for VASCEPA for the cardiovascular risk reduction indication, which is a significant milestone for the drug, given that China is the largest market for cardiovascular-related products. Edding is following up that success with continued efforts to secure a national reimbursement drug listing in China.

Supporting all of our commercialization and expanded access efforts worldwide are our medical affairs, R&D and regulatory teams who expertly and tirelessly advocate for and conduct the critical work to advance the science behind VASCEPA and VAZKEPA. Nearly 5 years from the approval of VASCEPA in the U.S. for cardiovascular risk reduction, we and others are continuing to generate meaningful data that helps the clinical community further understand the value of VASCEPA and VAZKEPA to reduce cardiovascular risk when used as an adjunct to statin therapy to benefit patients further.

So far this year, our teams, along with KOL partners have presented more than 25 publications and abstracts that both individually and in aggregate help to advance an ever-broadening understanding of the science and value of IPE and EPA. Two recent examples of this important study drumbeat include recent abstracts and presentations at the European Society of Cardiology meeting in August and the European Association for the Study of Diabetes meeting in September. Importantly, this recent research has provided new insights on EPA's potential effect on elevated levels of lipoprotein(a) thought to be a key factor in cardiovascular risk and mortality for at-risk patients.

And our team will be supporting 3 abstracts at the upcoming American Heart Association meeting in November. We intend to continue to further advance this evidence on the utility and value of VASCEPA and VAZKEPA and IPE. Our teams have also made regulatory progress so far this year with approvals for our product for cardiovascular risk reduction in South Africa and China.

In summary, it's our obligation to get VASCEPA/VAZKEPA into the hands of as many patients around the world as possible. We've made progress under sometimes difficult market and reimbursement challenges, but as more stakeholders become increasingly educated on the strength of the VAZKEPA clinical data and what it means for patient care, our confidence in this product's global potential continues to grow.

Now let me turn the call over to Pete Fishman, who will review our third quarter 2024 financial results. Pete?

[Peter Fishman, executive]

Thank you, Aaron. Turning to Slide 8. Before I begin, I think it is important to introduce myself since I have assumed the role of Principal Financial and Accounting Officer of the company. I've served as the company's Global Controller since October 2022 and held roles of increasing responsibility within Amarin's finance team since 2019.

Overall, I come into this role with nearly 20 years' experience in various roles in finance, including accounting, financial reporting, tax and audit. The transition has been seamless, and I look forward to continuing to work with our tremendous global finance team in my new role.

Turning now to the numbers. In the third quarter of 2024, Amarin reported total net revenue of $42.3 million, including net product revenue of $41.9 million and $400,000 of licensing and royalty revenues compared to total net revenue of $66.1 million in the third quarter of 2023. U.S. product revenue was $30.6 million in the third quarter of 2024 compared to $62.4 million in the third quarter of 2023. This decline was driven by lower net selling price due to the generic competition in the market and a decrease in volume due to CVS moving from exclusive to not covered.

Despite the revenue decline, the U.S. business continues to deliver significant cash. Product revenue this quarter also reflects European net product revenue of $4.3 million, a $3.5 million increase over the prior year period and an $800,000 increase compared to last quarter, both driven primarily by revenue growth from Spain and the U.K.

Third quarter 2024 cost of goods sold was $26 million compared to $36.2 million in the prior year period. Gross margin was 38% compared to 64% in the prior year period, excluding inventory restructuring charges in the third quarter of 2023. This decline is due to a decline in net selling price in the U.S.

Total operating expenses in the third quarter of 2024 were $41.4 million, comprised of $36.9 million in SG&A and $4.5 million in R&D expenses, which is a reduction of approximately $10 million compared to the prior year period due to ongoing cost optimization initiatives.

Turning to the bottom line. We reported a GAAP net loss of $25.1 million for the third quarter of 2024 compared to a $19.3 million loss in the prior year period, reflecting the impact from the U.S. generic market.

Let me now turn to Slide 9 and our efforts and results in controlling costs and effectively managing our cash. As of September 30, 2024, Amarin reported aggregate cash and investments of $306 million, which includes receiving the $15 million Edding CVRR milestone payment in the quarter and no debt.

While we continue to navigate the ongoing challenges to our U.S. product revenues, we have successfully maintained a stable cash position over the last 9 quarters. Fundamental to that success has been and will continue to be a commitment to balancing a combination of preserving cash, managing costs and pursuing channels to expand product revenue.

Now I'll turn the call back over to Aaron for closing remarks before we begin the Q&A. Aaron?

[Aaron Berg, executive]

Thanks, Pete. Turning to Slide 11. As we've shared this evening, there's significant long-term value in VASCEPA and VAZKEPA. This is clear both from what Amarin has delivered as well as what the external world has expressed in terms of validation of the science, the impact and the value that our product can provide to patients. As we move forward, our focus is simple and clear: to harness the proven attributes of the product to expand access for patients. We'll focus on the strength of and opportunities for this product.

Over 10 years of science and clinical data, including more than 300 publications on VASCEPA and the backing of 50 medical societies around the world, recognizing the value of the product. The significant experience and support this product has gained through its commercialization in the U.S., the extended IP position in Europe out to 2039, the unmet need globally to reduce cardiovascular risk as cardiovascular disease remains the #1 killer worldwide, the multiple untapped markets in Europe and the rest of the world where access can be further opened beyond what we've achieved so far and accelerating usage in key launch markets, all in the name of our commitment to maximize the value potential at a faster pace.

We also remain fully committed to our public listing. It's very important for us as well as to our shareholders. In addition to continuing to drive the business, there are a number of mechanisms we're considering that would help us regain Nasdaq compliance.

Overall, we're making progress on our core priorities, but there's much more work that needs to be done quickly. We understand the need to accelerate performance to realize the potential of VAZKEPA and VASCEPA and that's what I and the entire team at Amarin are committed to delivering. Before we turn to Q&A, I'd like to thank our Amarin colleagues and partners around the world for their continued commitment and dedication. Your efforts are sincerely appreciated and very important for patients around the world. Thanks for your efforts.

And with that, operator, let's begin the Q&A portion of the call.

[Operator]

[Operator Instructions] And our first question comes from Roanna Ruiz with [ RBS ].

[Unknown Analyst]

This is [ Maizi Ali Mohamed ] at Leerink Partners on for Roanna Ruiz. Just 2 from us. So the first, given the increasing rebating in '24 for VASCEPA, what are your expectations for net pricing pressure kind of going forward in the short term? And then secondly, are there any additional trials or data points that you believe could enable greater reimbursement coverage for VAZKEPA in the EU and/or China?

[Aaron Berg, executive]

First of all, thank you for your questions. We appreciate it. Thanks for taking the time to listen this evening. Regarding rebates and rebate pressure in the U.S., as you know, we've been in an increasingly generic market with the brand in the U.S. since November of 2020.

The fact that we've maintained a 50% share of our volume speaks to the great work done by the team and the uniqueness of the product. In that, of course, the pressures have been increasing. There are now 8 generic companies that are marketed in the U.S. So we do expect rebates to continue to need to go up.

But that being said, we've maintained our exclusives. That's helped us maintain our volume. We still believe we can compete profitably in the U.S. and we'll continue to do that for the foreseeable future. Of course, it's a generic market. So it's something that as time goes on, those pressures would increase. But each year, every time we get to this point in time, we say the same thing and we've managed to maintain that 50% share. And hopefully, that will continue going forward.

In terms of trials or markers to help increase reimbursement in Europe, I'm joined here by Dr. Steve Ketchum, he's our Executive Vice President of R&D and Chief Scientific Officer. Steve, do you want to touch on that?

[Steven Ketchum, executive]

Yes, certainly. So as we continue to support the brand globally, including in Europe, we continue to conduct various subgroup analyses in high-risk patient populations, which not only interesting to the clinical community in terms of peer-reviewed publications and congress presentations, but also sometimes in pricing and reimbursement context to provide that context in patients who are difficult to treat and clearly at high cardiovascular risk.

There are -- obviously, over time, there are other data points from other research groups that we feel continue to support that highly purified EPA is efficacious. And we continue to keep an eye on those and to fold them into our story as well.

[Aaron Berg, executive]

And I'll just build on that because it's a good question. So it would be -- certainly, if there was some silver bullet marker or some additional data that would add to what we already have and accelerate the process, we'd certainly be looking at that. The good news for us is we're well armed. We have tremendous clinical data now.

And part of what we're experiencing in Europe with reimbursement is not really unique to Amarin. It's a challenging market dynamic for reimbursement for even some of the biggest companies with the biggest brands in Europe. So we feel very well armed with what we have, managing the process as best we can.

We're always looking for ways to improve. We've certainly done it in the last year or so, we've focused in on acute coronary syndrome patients. So they're a higher-risk patient population, more costly, more easily identified, more likely to get -- to have additional events, more likely to get combination therapy. And that seems to be helping accelerate things not only from a reimbursement perspective, but from a launch uptake perspective.

So we're confident in what we have. We realize that it's never fast enough, but I think the team is executing well and we look forward to more progress. As I mentioned in the prepared comments, hopefully, we have more to say about Italy fairly soon. We look forward to that.

[Operator]

The next question comes from Jessica Fye with JPMorgan.

[Jessica Fye, analyst]

So we noticed that there is some momentum in the rest of the world in terms of revenue. Can you please give us some color on what is driving that? And then as well as EU, can you talk about the growth dynamic there? And then for the net price for VASCEPA in U.S., how do we think about the net price going forward? Do you think this is stabilized? Or like do you think it's going to continue to erode?

[Aaron Berg, executive]

Sure. So regarding the momentum in the rest of the world, as we mentioned, we're early in a number of countries with launch, with reimbursement, with a number of partners and a number of regions that we're just getting going. So fortunately, this is a product we know from the U.S. experience that when you educate, when you have the chance to promote that physicians respond well.

It doesn't always happen fast in every market, but it happens. And the good news is we have a number of partners. We now have 9 partnerships in rest of the world. And those -- in some of those regions, they are starting to kick in. So we're starting to see some of that momentum.

Hopefully, we'll see some of our partners make greater progress. Australia just got started for one. China just got started with the cardiovascular risk indication. And hopefully, that will accelerate being the big market that it is. And hopefully, that will continue.

The Europe growth dynamics, we've been encouraged by both U.K. and Spain and maybe for slightly different reasons. U.K., we launched close to 2 years ago. We changed our strategy, made a number of changes in the organization within the last year and we're seeing that those changes have made a difference and we're seeing a greater acceleration in growth. Spain was, from our perspective, from launch on and now we have Portugal as well for reimbursement, very good execution.

Well -- the market is receiving it very well. We're seeing early signs of impact of education and promotion and growth and we're excited to see what Spain can do going forward. Hopefully, we have good news on Italy going forward and as well as continued good news in some of these, again, back to the rest of the world, some of the rest of the world partnerships. So the foundation, we think, is getting stronger. And hopefully, we see more countries come online in the near term.

In terms of the net price, I'm going to turn it over to Pete to address that in the U.S.

[Peter Fishman, executive]

Sure. Thanks, Aaron. I think just building off of what you said in the last question in terms of net price, being in a generic environment, we are seeing price pressure working with our partners and also the mix in terms of our business moving more towards Medicare Part D from commercial as a result of the CVS going from exclusive to not covered. Medicare is at a higher discounted rate. And so we are seeing some pricing pressure there. And just given the environment, we expect to see that pressure continue moving forward.

[Operator]

[Operator Instructions] The next question comes from Paul Choi with Goldman Sachs.

[Kyuwon Choi, analyst]

I wanted to ask about prioritization of capital. Your cash position has held relatively steady for several quarters now, but I think you've also discussed a share repurchase program. I just wanted to ask on the status of that. And secondly, as you think about business development opportunities and looking for potential pipeline assets, can you maybe just comment on how you're seeing the landscape and your capacity there?

[Aaron Berg, executive]

Sure. Thanks, Paul. Thanks for joining us. So prioritization of capital and on the repurchase, Pete, do you want to address both of those?

[Peter Fishman, executive]

Sure. So in terms of the repurchase, as you know, we did get approval to initiate a repurchase program. We have that ability to initiate it for 10 years. And similar to what we said last quarter, we're continuing to monitor the business and market dynamics to determine whether we will commence that program. At this point, we have not repurchased any shares. In terms of just general kind of cash prioritization, we're always continuing to be mindful of our cash balance.

We have been neutral to cash positive for 9 straight quarters. During this quarter, we did receive the $15 million Edding CVRR milestone payment. While we don't expect to have one -- another material onetime milestone in the next quarter, we still are mindful of the cash and monitoring it and making sure that our investments are prudent and that we are always looking for ways to find cost optimization.

[Aaron Berg, executive]

And then the third question on business development and any consideration of looking at additional assets. Right now our focus is on executing with VAZKEPA and VASCEPA. I think that we are very optimistic about our ability to grow that. We're starting to see that momentum that has been hard fought. We know that we need to -- we'd like to get on firmer footing. When it comes to that growth, the cash we have, as you can see and you followed us the last few years, we've been very judicious about managing our cash and our operating expenses.

We've had several restructurings, including one last year with a singular focus to grow VAZKEPA in Europe because that market is enormous. We have till 2039 for a runway now, thanks to significantly expanded IP protection. And those markets, we've barely scratched the surface. And in some of those key markets, we haven't even gotten on the market yet.

Again, not unusual for Europe and for a lot of companies, not that unique to Amarin, but we have a product that has significant upside and we're determined to find a way to get it in more patients' hands any way that we can. So that's our focus right now. In the future, we'll consider putting another product in the bag if we get to that point. But right now we're pretty laser-focused.

[Operator]

This concludes the Q&A portion of the call. I would now like to turn the floor back to management for any closing remarks.

[Aaron Berg, executive]

Yes. Thank you, John. First of all, thanks, everybody, for joining us this evening. We appreciate it. Just as a reminder, on November 14, we'll be hosting a virtual analyst and investor event. And what we'll do is we'll focus on the VASCEPA and VAZKEPA franchise, focusing in on the dynamics for some of the key geographies that represent the future of that franchise, our growth and in particular, a focus on Europe. And you can register for that through Amarin's corporate website. And beyond that, thanks again for joining us. Have a good evening. Bye now.

[Operator]

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