Amarin Corporation PLC

NASDAQ:AMRN

Earnings Call Analysis

Amarin Focuses on Cash Preservation, Supply, and R&D

Amarin reported a net loss of $5.8 million in Q4 2023 with cash and investments totaling $321 million, showcasing a quarter of sustained positive or neutral cash flow. The company is committed to cash preservation, having improved their cash position by $10 million from the previous year and is advancing cost reduction initiatives. Amarin confidently renegotiated supply agreements to meet demands and reduce commitments. Regulatory approval processes for their product in China are expected to conclude in 2025, adding to their optimism. The company remains engaged with its shareholders and continues to explore new indications for its product.

Financial Health and Cost Management

Amarin Corporation has showcased its abilities to manage costs effectively by reducing its operating expenses by $21 million in comparison to the first half of 2023, marking a pathway to achieve a $40 million reduction in operating expenses by July 2024. The company reported a net loss of $5.8 million for the fourth quarter of 2023, translating to a loss per share of $0.01. Despite the net loss, Amarin has maintained a positive cash flow generation for six consecutive quarters, ending 2023 with a $10 million higher cash balance year-over-year, reaching $321 million. Focused on cash preservation, Amarin plans to initiate a shareholder repurchase program in Europe, contingent upon pricing reimbursement decisions and legal approvals.

Strategic Focus to Maximize Shareholder Value

Amarin intends to drive shareholder value by concentrating on operational momentum across all business areas, as outlined by CEO Patrick Holt. With a strong underlying foundation—best-in-class science, a large global market opportunity, a dedicated team, and robust finances—the company optimistically looks towards future growth options, leveraging progress in the U.S., Europe, and the Rest of World markets.

Supply Chain Confidence

The executive team expressed confidence in meeting potential supply demands, thanks to solid relationships with key supply partners and progress made in renegotiating supply agreements. This confidence ensures the company's readiness for demand increases from Europe or other global partners.

Investing in the U.S. and Global Market Dynamics

In the intensely genericized U.S. market, Amarin aims not to grow the market but to maintain its leadership position. The company ended 2023 with a leading market share of 57%, demonstrating exceptional performance and operational capabilities. Close monitoring of market dynamics, with particular attention to the competition and the potential pivot to generics, reflects adroit navigation of the challenging market landscape.

Global Expansion and Revenue Growth

Amarin is capitalizing on new and existing international partnerships, seeing promising revenue growth prospects. Notably, partnerships in Canada, the Middle East, North Africa, and China are highlighted as significant contributors to future revenues. Strategic alliances have evolved from establishment to driving commercial outputs, indicating a phase of growth and increased revenue in the Rest of World segment.

European Endeavors and Market Penetration

Europe remains a critical focus for Amarin, with efforts directed towards enhancing market access in key regions like the U.K., Spain, and Italy. In Germany, the company is reassessing strategies for re-entry into the market, considering local patient populations and working with local authorities to find appropriate pathways to market reentry. Italy's pricing and reimbursement conclusions are anticipated in 2024, further advancing the company's European presence.

Guidance on Operating Expenses and Gross Margin

Amarin maintains its operational expense forecast within the $50 million per quarter range and intends to adhere to this level by offsetting new investments with alternative cost reductions. Gross margin, which saw a decline to 58% due to launch supplies for international partners, especially in China, is expected to fluctuate based on product uptake in new markets. The management promises updates on margin developments as they unfold.

Earnings Call Transcript 2023-Q4

[Operator]

Welcome to Amarin Corporation's Conference Call to discuss its Fourth Quarter and Full Year 2023 financial results and business updates.

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

[Mark Marmur, executive]

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 on 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, 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. Patrick Holt, Amarin's President and Chief Executive Officer, will provide a brief overview of 2023 highlights and 2024 priorities; and Tom Reilly, Amarin's Chief Financial Officer, will provide a review of our fourth quarter and full year 2023 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, executive]

Thank you, Mark. Good morning, everyone, and thank you for joining us today. Before we review our 2023 highlights and our 2024 priorities, I want to take a moment to reflect on our strategy at Amarin. Everyday, our team is focused on driving operational momentum to maximize the patient uptake of VASCEPA/VAZKEPA. To enhance the value of Amarin and deliver shareholder value, we must drive operational momentum across our 3 key regions. In Europe, where we have a potential IP runway out to 2039, we are focusing efforts and investment to accelerate prescription growth and revenue as well as secure pricing and reimbursement in those key markets. In the U.S., we're maintaining and extending our IP market leadership. And in the Rest of the World, we're enabling our partners to get our product into the hands of as many patients as possible. We firmly believe this focus on operator momentum is the best path forward for Amarin and will more strongly position us or potential future options.

Turning to Slide 6. While we believe this strategy is the best way to deliver shareholder value today, the only way to gain shareholder confidence is to deliver against it. We have made meaningful progress in 2023, and we have clear priorities in place for 2024. For Europe, in 2023, with new leadership and a more focused strategy in place, our teams made launch progress and have advanced pricing and reimbursement goals. In Spain, our team is focusing on health care practitioners who are early adopters of cardiovascular products. We are continuing to deliver strong launch progress such that we now have approximately 2,500 patients on therapy. In the United Kingdom, we have a more focused strategy in place, including driving uptake in key accounts. Currently, we have at least 1,500 patients on therapy.

Turning to pricing and reimbursement. We've secured pricing reimbursement across 9 countries in Europe. As I have shared previously, we have strengthened our focus to advance our opportunities in key EU5 markets. I'm pleased to share in Italy, we have now resubmitted our dossier and will advance this process with the authorities to potentially achieve market access for VASCEPA by the end of 2024. In France and Germany, we are sharpening our scientific arguments and have strategies and plans in place to advance submissions for VASCEPA in these markets. We do not expect these processes to conclude in 2024. We will continue to communicate progress on France and Germany as additional steps are achieved.

Importantly, we are also aiming to successfully conclude pricing reimbursement decision in at least 5 additional markets in 2024. We remain confident in our path forward in Europe. We have patents and applications that have the potential to extend our IP up to 2039. As a testament of this progress, we successfully defended our 2033 patent from opposition. We expect to share more on this topic in the coming months.

Turning to the United States. In 2023, we continue to extend IP market leadership, closing the year with a 57% market share. We achieved this through focused investment in managed care, trade and medical capabilities to extend VASCEPA's life cycle despite the elimination of our sales force and reduced marketing spend in July.

As we turn to 2024, we have begun the year in a slightly improved position compared to last year. Based on what we currently know with our exclusive accounts, these represent at least 50% of the total IP market volume. While we are encouraged to start the year in a solid managed care position, the market remains highly dynamic, and we continue to monitor this closely. We do expect Q1 2024 results to be impacted by typical first quarter payer dynamics. We continue to stand ready to execute aggressive approaches, including the potential future launch of an authorized generic bolstered by our strong supply position to retain market leadership within the IP market.

In the Rest of World, in 2023, we made progress on regulatory market access and commercial fronts as well as new partnerships. In China, the second largest cardiovascular market globally, Amarin's partner, Edding, launched VASCEPA in October for the very high triglycerides indication. Additionally, that NMPA has accepted the regulatory filing for the cardiovascular risk reduction indication, which opens up the potential for future national reimbursement and drug listing.

In 2023, Amarin also entered into 3 new partnerships across 15 countries. In 2024, our focus for Rest of World shifts toward enabling our partners to obtain market access and commercial uptake across key markets.

Finally, in Research and Development and Medical, our teams delivered important progress with data publications and medical education supporting our brand globally to build confidence in our science. In 2024, we will continue to build on this momentum, including additional data on REDUCE-IT and EPA. Indeed, we have 7 abstracts at the upcoming American College of Cardiology meeting in April. We'll be showing more on this in coming weeks. This important operational progress has supported our financial position, with $321 million in cash and no debt. As you're aware, due to our recent progress in our financial position, we announced plans for a share repurchase program of up to $50 million. I'm pleased to share that we are on track to complete the necessary shareholder and U.K. High Court approvals. We continue to anticipate completing these steps in the second quarter of 2024, and that share repurchases would commence shortly thereafter. In summary, 2023 was a meaningful year for operational momentum, and we are well positioned to continue to build on this in 2024.

Now, I'd like to hand over the call to Tom Reilly to review our fourth quarter and year-end 2023 financial performance. Tom?

[Thomas Reilly, executive]

Thank you, Pat. Good morning, everyone. I'm pleased to report details on our financial performance for the fourth quarter of 2023. In the fourth quarter of 2023, Amarin reported total net revenue of $74.7 million, including net product revenue of $70.6 million versus $66.1 million in the third quarter of 2023 and $4.2 million in licensing and royalty revenue.

U.S. product revenue was $64.9 million, with stable performance in the U.S. despite multiple competing generics on the market. The U.S. business continues to provide profit supporting our expansion into Europe.

The revenue results include Europe [ PM ] product revenue of $1.5 million, a 65% increase versus the third quarter of 2023, reflecting early revenues from European markets, including Spain and the United Kingdom. We recognized $8.4 million in the Rest of World revenue in the fourth quarter of 2023, including product revenue of $4.2 million related to commercial sales to our partners in Canada, China and the Middle East, and licensing and royalty revenue of $4.2 million, resulting primarily from the achievement of the Edding CVRR milestones.

Cost of goods sold in the fourth quarter of 2023 were $29.6 million compared to $23.6 million, excluding restructuring in the third quarter in 2023. Amarin's overall gross margin on net product revenue in the fourth quarter was 58% compared with 64% in the third quarter of 2023. This was primarily due to an increase in 1 supply sales to our partner, Edding.

Moving on to operating expenses. Operating expenses were $49.7 million in the fourth quarter, comprised of $43.9 million in selling and General and Administrative expenses, and $5.8 million in Research and Development expenses. In the second half of 2023, Amarin reported operating expenses of $101.2 million. This represents a $21 million reduction in operating expenses versus the first half of 2023.

We are on track to deliver the previously announced $40 million reduction in operating expenses by July 2024. Amarin reported a net loss of $5.8 million for the fourth quarter of 2023 or basic and diluted loss per share of $0.01.

Let me now turn to our efforts and results in controlling costs and effectively managing our cash. As of December 31, 2023, Amarin reported aggregate cash and investments of $321 million. Importantly, this is the sixth consecutive quarter of positive or neutral cash flow generation for Amarin, and our cash balance is now $10 million higher when compared to December 31, 2022.

In 2023, we made progress in controlling our costs and managing our cash position through our cost reduction programs and renegotiating supply agreements. In 2024, we will continue to focus on cash preservation prudently invest in right opportunities, particularly in Europe, based on pricing reimbursement decisions and pending shareholder and U.K. High Court approvals will initiate our shareholder repurchase program.

With that, I will now turn the call back over to Pat for closing remarks and to begin the Q&A portion of our call. Pat?

[Patrick Holt, executive]

Thank you, Tom, for the financial overview of our results. Our team is focused on operational momentum to maximize shareholder value across all 3 areas of our business. We believe we have the right plan, focus on operational momentum to drive shareholder value. We have a strong future because of our fundamentals, best-in-class science supporting VASCEPA/VAZKEPA, a large global opportunity to impact cardiovascular patients, a team that is dedicated to delivering results, and a strong balance sheet.

Finally, thank you to our colleagues for their commitment and dedication. I look forward to driving shareholder value together.

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

[Mark Marmur, executive]

Thank you, Pat. As we announced last year, 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 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.

So Pat, we received a number of questions on the company's long-term strategy in ways that we plan to maximize shareholder value. What would you say to these investors?

[Patrick Holt, executive]

Thanks for the question. I get this question a lot. That's a really an important question. And we believe, the best path forward for us to both increase our value and put us in the best possible place for future strategic options is today to focus on our current efforts around operational momentum, whether that be in Europe, in the U.S. or in the rest of world.

As we shared earlier in the call, we really are making progress on all 3 fronts, which provides us greater optimism and optionality for the future.

[Mark Marmur, executive]

Great. Our second set of questions focuses on China and Asia Pacific. What can you tell us on progress around the commercial launch in China? And what is the status of the cardiovascular risk reduction regulatory following China? Also, more broadly in Asia Pacific, can you share any updates on efforts with our partners?

[Patrick Holt, executive]

Well, there's a lot in that. And as some of you know, I know this region pretty well. So let me break that down in some parts.

Firstly, to the China launch. So Amarin's partner, Edding, is really making important progress in China, which I'll remind everybody, is the second-largest cardiovascular market globally. Edding have launched VASCEPA for very high triglycerides in Q4 2023. To give you a flavor, the Edding sales force is covering 200 hospitals, which includes around 500 key opinion leaders, the majority of which are cardiologists in the 3 largest cities of Beijing, Shanghai and Guangzhou. So in summary, the launch is progressing well, and the structure of the agreement provides immediate profitability to Amarin.

So let's move from today and also think about the future in China as we reflect upon the cardiovascular risk reduction indication. The NMPA has accepted the regulatory filing for cardiovascular risk reduction, which opens up the potential for national reimbursement drug listing. The submission was accepted with a clinical trial waiver, meaning a separate clinical trial will not be required in order to be reviewed for approval. The teams are now focused on advancing that submission together with the authorities, and we expect the regulatory review process to conclude in 2025.

Asia Pacific is a large region, so let me just touch on some other areas within the region. As you know, last year, we entered into partnerships in Australia and New Zealand, with CSL Seqirus, and also 11 Asian markets, including South Korea with Lotus Pharmaceuticals. I'm pleased to share that CSL is advancing pricing and reimbursement processes in Australia with the authorities. And in other markets, our partner, Lotus, is advancing regulatory discussions and filings with the various authorities across the region.

[Mark Marmur, executive]

Great. Thanks, Pat, for that information on China and Asia Pacific.

Now turning to the U.S. Is there a path toward growth in the market? Could we potentially take market share from other products or classes?

[Patrick Holt, executive]

Great question. And naturally, our U.S. revenues and cash flows are incredibly important to our business. When we take a step back and we think about the U.S. market and where it stands today, it's important to remember that the IP market in the U.S. is highly genericized at this point. Our focus has been and continues to be to maintain IP market leadership. And as a result of that, not focused on growing the market. We really have achieved a highly atypical performance 3 years post LOA to end 2023 with a market-leading share of 57%. We've been able to secure market leadership and continue our success through our exclusive contracts, led by our capabilities in payer, managed care and medical areas.

Again, as we mentioned, we've started 2024 in a strong position in terms of our exclusive contracts. But to remind everybody, the dynamic market, and we do watch it very closely and continue to assess our optionality for our branded product and beyond that should we consider other strategic alternatives.

In terms of taking share from other products or classes, given those generic dynamics, we do not view this as an optimal strategy.

[Mark Marmur, executive]

Turning to supply. If we see demand increase from Europe or Rest of World partners, are you confident that we can meet those supply demands?

[Patrick Holt, executive]

It's a very important question. And we do have strong relationships with our key supply partners. Over the last several years, we've made really important progress, renegotiating our supply agreements to ensure that we can both meet our demands as well as reduce key supply commitments. We feel really confident that we can meet those supply demands moving forward.

[Mark Marmur, executive]

Now, 1 last question on the R&D side from the Say Technologies questions. Is Amarin working on advancing any additional indications for VASCEPA/VAZKEPA?

[Patrick Holt, executive]

I was really pleased this question came up. And it's such an important question when you think about the core strength that Amarin has in terms of our R&D team and our IP capabilities and leadership. This is the team that has developed and advance the molecule from day 1, and deliver the REDUCE-IT data that really has a global impact that we see today. With our team in place, we do continue to look at opportunities for new indications and we will update investors based on potential future progress of that work. So 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 all of our shareholders, and the Say Technologies platform is one way that we are trying to increase engagement and 2-way dialogue with you. We look forward to continuing to hear from you and answering your questions on this platform as well as other opportunities moving forward.

[Mark Marmur, executive]

Thank you for those updates, Pat. We'll now open the Q&A up for additional questions.

[Operator]

[Operator Instructions] Your first question for today is from Roanna Ruiz with Leerink Partners.

[Roanna Clarissa Ruiz, analyst]

So could you talk a bit more about the ongoing generic competition in the U.S.? Like what trends are you seeing in the field? And what do you expect in terms of possible pressure on VASCEPA net price in the next couple of years?

[Patrick Holt, executive]

Roanna. As you probably have followed, there are more generics that have got regulatory approval, there are more generics that have also got prices. And with that said, what we see in terms of the market dynamics in the market so far, they remained fairly stable.

So as we mentioned, we closed the year and we started the year with a strong position with our exclusive contracts that represents greater than 50% of the IP volume. So as we end the year and start the year, we are feeling really good about that position. But as I'm sure you've noted, there is more dynamics and there are more entrants in the market. So we continue to monitor it very closely.

But I would say so far, and we haven't seen any dynamic changes from what we have seen historically. But obviously, we track it closely. And as you know, we have optionality in the short term as well as the long term to maximize the economics for us in the U.S.

[Roanna Clarissa Ruiz, analyst]

Yes, makes sense. And a quick follow-up on the Rest of World. I noticed it's gaining some traction. So could you talk about what regions you expect might contribute the most momentum to future growth in revenues in 2024 and beyond?

[Patrick Holt, executive]

Yes. It's a great question. As I mentioned, we're really -- it's pleasing to see the progress in 2023. As you think, we always -- we signed up some new countries in 2023. If you take a step back in 2023, the main revenue sources, until China came on board, was really coming from Canada and then parts of Middle East, North Africa. So what we'll see in 2024 is certainly continued value coming from those existing partnerships such as I've just mentioned. So I do expect that China will have more progress in 2024. And then there is the opportunity, I think as some of these partnerships start to go from signing through regulatory process such as Lotus, market access, reimbursement and pricing, such as CSL Seqirus in Australia, New Zealand, you're starting to see a shift from entering partnerships to really more driving through those pre-commercial and commercial outputs. So we're pleased that we're progressing through that life cycle of partnership and alliance management, I would say, and we see that shift in the business towards more revenue -- market access and revenue generation. And internally, that means we're beefing up our capabilities and leadership to support that group.

And that's -- to add that. It's really -- it is a key part of our goals and our strategy, that Rest of World business, and it provides immediate profitability for us.

[Operator]

Your next question for today is from Jessica Fye with JPMorgan.

[Unknown Analyst]

This is Na Sun on for Jessica Fye. I have a question on your progress in launching VASCEPA there. Can you just talk a little bit about how to accelerate the growth in U.K. And then for Germany, have you come up with a plan to reenter the market there? And then for Italy as well?

[Patrick Holt, executive]

Thanks Na Sun. Look, Europe is obviously critical for us. It's a key focus of our investments and a key focus of the whole organization as we move forward. So as we break that down, we think about those key launch markets. And as we've previously mentioned, the U.K. is quite an individual market, and the uptake in the U.K. is typically solo. We are making progress with a more focused strategy on those key accounts. And as I signaled earlier, we now believe -- we estimate we have at least 1,500 patients on therapy.

Building on that, we did say from that moment of launch last September that we did expect Spain to be a faster uptake market, and that is proving true. So we're pleased with the progress and the uptake we're seeing in Spain on a national basis. And today, we see -- we estimate we have around 22,600 patients on therapy, which is important progress for us. So they're 2 key launch markets for us. As we move into some of the reimbursement markets, we've resubmited in Italy, building on our previous strong scientific assessment, and we do expect Italy pricing reimbursement to conclude in 2024. And then if we think about Germany, to your next question, you know our history in Germany. So that's a topic where we've taken a step back and we are redeveloping a potential new strategy to enter the market. We're working with the authority to assess different ways to consider patient populations that can be relevant for the German market, and we're working with the authorities on those plans, and we continue to advance that through 2024. But as I mentioned, I don't expect that those processes will conclude in 2024.

[Operator]

Your next question for today is from Louise Chen with Cantor Fitzgerald.

[Suowei Wu, analyst]

This is Wayne on for Louise. So first, you have reiterated that you're on track to deliver the $40 million annual savings. And so how should we think about the operating expense for 2024 because compared to the second quarter, you said about $7 million in the third quarter and $8 million this quarter? So should we expect a similar number going forward?

And then the gross margin has dropped to 58%. So how should we think about this going forward?

[Thomas Reilly, executive]

Yes. Great. This is Tom. Related to the operating expense and the $40 million, which we're on track to deliver and what we are expecting -- expectations for expenses. As mentioned before, we reduced expenses from the second half to the first half of '23 by $21 million. Our cost basis is approximately $50 million per quarter. Our expectation is to stay within that range, depending on pricing reimbursement decisions. We will invest in those opportunities, but we'll find other ways to reduce costs. So our overall expectation is to stay within that $50 million operating expense basis.

Related to your question on gross margin, very good question. Thanks for picking it up. What you've seen versus Q3 is a deterioration of gross margin, but that's primarily due to launch supply that we provided for our partners, in particular in China. So as the China market is moving forward, we're providing products for revenue there. It's about a 2.5 to 3-point reduction in margin impact this quarter versus the previous quarter.

And then the question on how do you expect for margins moving forward. I think it all depends on the uptake in China and how much product [indiscernible] we'll be providing. But we'll give updates on the progress of the China market.

[Operator]

Your next question is from Paul Choi with Goldman Sachs.

[Khalil Fenina, analyst]

This is Khalil calling in for Paul. I guess my question is about the exclusive contracts that you've mentioned in the past. As those are renegotiated, have you seen any additional pushback as more generics enter the market? And have you or will you set a threshold for those sort of deterioration on those at which point the company would pivot to your own generic?

[Patrick Holt, executive]

Khalil. Look, obviously, we track those contracts very carefully. We do see, I would say, on an annual basis, to renegotiate our exclusive contract, we do see annual impact to those pricings in the sort of low double-digit range typically. And that's been something that we are seeing consistently. We don't see necessarily significant changes to that, but that's the sort of range that we see.

What's really pleasing is we have had a strong end to the year and a strong start to the year in terms of how we're landing our negotiations. So the net-net of that means that we are participating in greater than 50% of the IP market volume. That has enabled us with our great managed care and trade and medical capabilities to pull through as we close 2023, a 57% market share in retained market leadership.

To your second part of your question, of course, we track the economics and the overall profitability incredibly closely. We have specific scenarios in our mind as to when we think those are attractive and when they start to become more marginal, and we have plans in place to react based on how those dynamics change, should they change.

But as it stands right now, our focus is to extend our branded life cycle as long as we can. Our organization, our U.S. team, from my perspective, has delivered a highly atypical performance for over 3 years since LOA, which provides incredibly important profits for the business, particularly for our growth in Europe.

So we couldn't be happier in terms of how we finished the year and how we started the year. But as you well know, it's highly dynamic. We monitor it very closely.

[Operator]

We have reached the end of the question-and-answer session. And I will now turn the call over to Patrick for closing remarks.

[Patrick Holt, executive]

Well, thank you all for your attention, and thanks for all the Q&A. We really appreciate the interest, and we look forward to having additional conversations on these important results in the coming days ahead. So thank you again for your time, and wish you a great day ahead. Thank you.

[Operator]

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