Q3 2024 Amarin Corp PLC Earnings Call

It's been straightforward.

To determine our path forward and execute the best strategies to drive access to and use of Vascepa. The skipper for the millions of at risk patients across the globe.

When 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.

<unk> has the potential for significant growth value impact globally that remained substantially untapped. These.

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 products.

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 the skipper 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 four decades of progress in cardiovascular medicine cardiovascular disease remains the number one 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.

Exception 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 200000 in the U S, resulting in more than 80% growth in new prescriptions in the firm.

First year post publication of reduce it.

This history of uptake and market response provides evidence that with time to promote an educated and supported by outstanding execution providers respond favorably to vascepa as a therapy that can benefit their patients.

We apply that experience and learnings from the U S to Europe.

<unk> has the potential to grow substantially with a large eligible patient population based only 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've only scratched the surface of our pricing and reimbursement and launch progress in many markets to date, we've unlocked access and launched in eight European countries.

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 best kept up for at risk patients in a number of additional European countries.

Our partner, adding farm received regulatory approval for Vascepa.

<unk> risk reduction indication, which is a significant milestone for the drug given that China is the largest market for cardiovascular related products.

Adding this 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.

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 invest capital.

Nearly five 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 vascepa to reduce cardiovascular risk when used as an adjunct to statin therapy to benefit patients further.

So far this year our teams along with Kols partners have presented more than 25 publications and abstracts that both individually and in aggregate helped to advance an ever broadening understanding of the science and value of IP and EPA.

Two recent examples of this important steady 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 EPS potential effects when elevated levels of <unk> protein little a thought to be a key factor in cardiovascular risk and mortality for at risk patients.

And our team will be supporting three abstracts at the upcoming American Heart Association meeting in November.

Star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May press star two if you'd like to remove your question from the queue for.

For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys, one moment, please while we poll for questions.

Okay.

Okay and our first question comes from Ryan <unk> with RBS. Please proceed.

Yes.

Hi, This is made the Ali Muhammad at Leerink partners on sorry, Ruano Louise just two from US. So the first given the increasing rebating in 'twenty four or vest Sherpa, 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 <unk> in the EU and China. Thank you.

Okay.

First of all thank you for your questions. We appreciate it and thanks for taking the time to listen this evening.

Regarding rebates and rebate pressure in the U S as.

As you know we've been in.

Increasingly generic market.

With the brand in the U S. Since.

In November of 2020, the fact that we've maintained our 50% share of our volume.

Speaks to the great work done by the team and the uniqueness of the product.

And that of course, the pressures have been increasing their now a generic companies that are marketed in the U S. So we do expect.

Rebates to continue to need to go up.

That being said we've maintained our exclusives that has helped us maintain our volume we still believe we can compete profitably.

In the U S and we'll continue to do that for.

Pressure.

Working with with our partners and also the mix in terms of our our business moving more towards Medicare part D from commercial as a result of the Cvs.

Going from exclusive to not cover.

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.

Speaker Change: Thanks Pete.

Speaker Change: Hopefully that does that answer your questions.

Well thank you.

Speaker Change: Okay. Thank.

Thank you.

Once again, if you have a question or comment. Please press star one on your Touchtone phone. The next question comes from Paul Chow with Goldman Sachs. Please proceed.

Paul Your line is live.

Hi, good afternoon, and thank you for taking our questions.

I wanted to ask about prioritization of capital your cash position is held relatively steady for several quarters now, but I think you've also discussed a out a share repurchase program I just want to ask on the status of that and.

Speaker Change: And secondly.

As you think about business development opportunities.

And looking for potential pipeline assets can you, maybe just comment on how youre seeing the landscape and your capacity there. Thank you.

Sure. Thanks, Paul.

Thanks for joining us so prioritization of capital and on the repurchase Pete do you want to address both of those.

Sure. So in terms of the repurchase as you know we did get approval to initiate a repurchase program. We have the ability to initiated 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 purchased repurchased any shares.

Speaker Change: In terms of just general kind of cash.

Prioritization, we are we're always continuing to be mindful of our cash balance.

We have been neutral to cash positive for nine straight quarters. During this quarter, we did receive a 15 million, adding CVR our milestone payment.

While we don't expect to have one of another material one time milestone in the next quarter. We still are mindful of the cash in and monitoring it and making sure that our investments are prudent and that we are always looking for ways to find cost optimization.

Speaker Change: And then the third question on obesity.

Speaker Change: And any consideration of looking at.

Speaker Change: Additional assets.

Speaker Change: Right now our focus is on executing with the scatter Vascepa I think that.

Speaker Change: We are very odd.

Optimistic about our ability to grow that we're starting to see that momentum that has been <unk>.

Speaker Change: Hard fought.

Speaker Change: We.

Know that we need to we'd like to get on firmer footing when it comes to that growth.

The cash we have is 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 to with a singular focus to grow the skipper in Europe, because that market is enormous we have.

Till 2039.

For our runway now thanks to <unk>.

Speaker Change: 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 all the mark to get again not unusual.

Speaker Change: For Europe and for a lot of companies at that unique to amarin, but we have a we have a product that has significant upside.

And we determined we are determined to find a way to get it more patients' hands anyway 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.

Speaker Change: Great. Thank you.

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

Thank you John first of all thanks, everybody for joining us this evening, we appreciate it.

As a reminder, on November 14th we'll be hosting a virtual analyst and Investor event and what we'll do is we'll focus on the vascepa and the skip a franchise.

Focusing in on the dynamics for some of the key geographies that represent the future of that franchise our growth and in particular, our focus on Europe and you can register for that through our corporate website.

And beyond that thanks, again for joining us havent been easing enel.

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