Amarin Corporation plc (NASDAQ:AMRN) Q4 2022 Earnings Call Transcript

Amarin Corporation plc (NASDAQ:AMRN) Q4 2022 Earnings Call Transcript March 1, 2023

Operator: Welcome to Amarin Corporation’s Conference Call to Discuss its Fourth Quarter and Full Year 2022 Financial Results and Operational Update. I would now like to turn the conference call over to Lisa DeFrancesco, Senior Vice President, Investor Relations and Corporate Affairs at Amarin.

Lisa DeFrancesco: Thank you, Holly. Good morning, everyone, and thank you for joining us. Please be aware that this conference call will contain forward-looking statements that are intended to be covered under the Safe Harbor provided by the Private Securities Litigation Reform Act. We may not achieve our goals, carryout 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, 2022, which have been filed with the SEC and are now available through the Investor Relations section of our website at www.amarincorp.com. We encourage everyone to read these documents. This call is intended for investors in Amarin and is not intended to promote the use of VASCEPA/VAZKEPA. An archive of this call will be posted on Amarin’s website in the Investor Relations section. Karim Mikhail, Amarin’s President and Chief Executive Officer, will lead our discussion, and Tom Reilly, Amarin’s new Chief Financial Officer, will provide a more detailed review of our fourth quarter 2022 financial results.

After prepared remarks, we will open the call to your questions. I will now turn the call over to Karim Mikhail, President and Chief Executive Officer of Amarin. Karim?

Karim Mikhail: Thank you, Lisa. Good morning. And thank you all for joining us today. While 2022 was a challenging year for Amarin, it was also a year filled with significant accomplishments that we believe have created the foundation for our future and gives us confidence that 2023 will be a year of tremendous evolution for the company. We are only beginning to see the results of the actions we took in 2022, and already in 2023. Throughout the remainder of this year, as each piece falls into place, we will be able to see more clearly a successful turnaround and the growing business that we have been building International. Amarin is in a unique position as we are building value for a product outside of the U.S. while facing increasing genetic competition in the U.S. market.

Our company is made up of people who come to work every day because they believe in our bold vision to stop cardiovascular disease from being a leading cause of death. This vision is what drives us. I’m proud of this team and what we have been able to accomplish together, and I’m excited for what we are able of accomplishing in the future as we continue to execute on our strategy. Today, I will briefly summarize the actions that we took in 2022 in the spirit of operational excellence to create value over the long term and bring the VASCEPA, VAZKEPA to as many eligible patients as possible across the globe. I will also provide an update on our launch in the UK and where we stand with our plans for global expansion. I will provide an update on our results in the U.S. where the team’s efforts to stabilize this business is providing the support for our global commercialization efforts.

I will then briefly discuss Amarin’s presence at the upcoming ACC meeting. Tom, will then discuss our financial results for the fourth quarter and our guidance for 2023, and I will conclude with a look ahead at the remainder of 2023. In 2022, we focused on three main areas, global commercialization, preserving our cash and ensuring that we have the right talent to execute on our new global strategy. We began the year 2022 negotiating pricing in one market in Europe and ended the year with our product available in five European markets. Since the beginning of 2023, we have added a sixth country with Switzerland where we have received individual reimbursement in February. We also have an additional five European markets in advanced stages of pricing and reimbursement negotiations.

Our objective is to conclude the vast majority by the end of 2023 as we focus on building a diverse and sustainable revenue stream in Europe. In Spain, we remain active in the reimbursement process and are confident in our ability to secure pricing in this market, we have gone through two rounds of review and made solid progress. We anticipate a potential third round of review imminently. In the Netherlands and Italy, we are in advanced changes of our price negotiations and are optimistic a decision could come around mid-year for these markets. We’re also making good progress in France, which typically can take slightly longer than the other markets based on historical benchmarks. Other markets such as Norway, Portugal, Israel, and others are also progressing with potential decisions expected this year.

We focused on preserving our cash. In the first quarter of 2022, we saw almost a $100 million in cash burn with new members on our management team. We took Swift action to renegotiate supply purchase arrangements. We also implemented a comprehensive cost saving plan in June, and today, we are excited to announce that we are on track to exceed our $100 million cost saving target. Thanks to our continued fiscal discipline and cost cutting efforts, which Tom will discuss in more details later in the call. These actions resulted in a cash flow positive fourth quarter in a year end cash balance of more than $300 million. And lastly, we also built a strong European commercial organization with expertise in medical affairs, product launches, and with extensive cardiovascular product knowledge.

Many of our team members come from companies where they successfully commercialized blockbuster drugs and have significant contacts, expertise, and knowledge of their respective markets. These professionals came to Amarin because of our leading product, our unmatched data, and our entrepreneurial culture, and they are utilizing their background and leveraging their experience to build the Amarin business and brand in Europe. This European team also benefited from the valuable experience that our US colleagues had building the brand successfully over several years in the US market. I’d like now to focus on providing an update on the UK. First, I think it’s useful to provide a reminder of the key highlights. We completed our NICE application in July of 2021, spend the year focusing on securing final NICE approval, which came in July of 2022.

90 days later, in October of 2022, the NHS funding was made available to begin adding VASCEPA to formularies, and in November of 2022, the national guidelines were published and they included VASCEPA place in therapy for UK patients. All of these steps and achievements were critical to help us establish a strong position for launch in this market. When we look at the pricing of VASCEPA compared to other oral analogs in the UK, we are extremely well positioned. Thanks, and large art to the effort of our local team. Given the volume of data available for VASCEPA and the efforts of our local team in conveying the value this product brings to patients are pricing from a daily treatment price perspective, far exceeds oral analogs across the Cardiometabolic spectrum of products in the UK.

When we look at the market access picture of VASCEPA in the UK, initial market access is trending ahead of other recent comparable launches in the market. Our team has unlocked 19 out of the first 20 priority accounts, which collectively represents 50% of the eligible patient population for VAZKEPA in the UK. As a reminder, the UK is a market that as a historically slower growing initially in terms of revenue. Based on these trends and the price achieved, we believe there is a viable strong and long-term business opportunity for VAZKEPA in the UK. Moving now to our progress on global expansion outside of Europe. As a reminder, we set out to achieve more than 20 regulatory approvals between 2022, 2024 in international markets. We achieved our 2022 objective of getting approvals in six markets, and already in 2023, we received an additional regulatory approval in New Zealand.

And yesterday, following this important approval, we announced an exclusive license and distribution agreement with CSL Seqirus in Australia and New Zealand. We are excited to announce this agreement with CSL Seqirus, a world class pharmaceutical licensing and distribution partner. CSL Seqirus brings highly experienced market access and commercialization teams in Australia and New Zealand that are well positioned to support pricing and reimbursement efforts for VAZKEPA, particularly with their strong record in successfully supporting pharmaceutical benefits listings, and eventual marketing and promotion to help us to deliver this important medicine to patients in these countries. Importantly, both Australia and New Zealand contributed significant number of patients to reduce it, so it is gratifying to know that we are moving in the direction of giving patients and physicians access to the product there.

We expect the next wave of approvals to include China through our partner Eddingpharm. Regarding China, our partner Eddingpharm is in charge of the regulatory review process. In their latest update, Edding indicated they expect an approval by mid-year as a result of delays related to the shutdown of the regulatory process in China for a period of time due to COVID-19 restrictions. We are working very closely with Edding to ensure we have the latest update from our partner. As of today, we have not received any indication that there are any open questions or concerns regarding the regulatory filing for our product. In Canada, HLS Therapeutics has a pain reimbursement from all major private and public payers, gaining access to a majority of eligible patients in Canada.

HLS continues to be in the launch phase in the public sector and they are seeing stronger growth with the product in provinces, where public access was secured. We are also actively negotiating potential agreements in the Asia Pacific and Central Eastern European regions, which would enable us to get this important product into the hands of clinicians and patients, and ensure we can extract value from these important markets. I’m pleased with the progress we have made our advancing international expansion plans. We remain focused on our core future objective, which is global growth and expansion for VASCEPA/VAZKEPA in Europe and internationally, as we believe expansion is the key to creating value for shareholders. We remain confident in the multi-billion-dollar market community for VASCEPA/VAZKEPA in Europe and international.

Moving to our U.S. business and our plans for ECC 2023, in the fourth quarter of 2022, we recorded $90.2 million in total net revenue including $88 million in U.S. product sales. Inline with last quarter despite the continued pressure from generic competition. This is the fourth quarter of four consecutive quarters of revenue stabilization in the U.S. in 2022. This unique achievement was only possible through the relentless dedication and efforts of our highly experienced U.S. team on the field and with the managed care organizations. We are continuing to maintain our share in the IPE market. Our trends in January and February support continued stabilization of the business. In the first quarter, we’re experiencing typical pharma seasonal trends that branded products like VASCEPA can expect in the U.S. from fourth quarter to first quarter, driven by co-pays and deductibles resetting for patients and their healthcare plans with a new calendar year.

We also expect to see some continued price erosion this year, as we continue to experience generic competition. Tom will talk in more details about what we can expect shortly. One compelling fact is that, our U.S. team has generated more than $1 billion in sales, since generic launched in 2020. And we continue to have multiple levers we can consider to maintain our profitability. As I mentioned earlier, our cost savings are ahead of plan and we have the ability to launch either a brand generic or an authorized generic as needed and at the right time. While we are planning carefully for all potential scenarios, it is clear today that, the strong and nimble infrastructure we retained in the U.S. provides us with the right team to continue to support business stabilization in the near term.

Lastly, we continue to benefit from the strong data that we have generated with reduce four abstracts were accepted and will be presented at the American College of Cardiology, meeting taking place later this week in New Orleans. We are excited to share new findings from the reducer trial that add to the wealth of data that has consistently validated the utility of VASCEPA and treating patients’ populations at high risk of cardiovascular disease. This important information coupled with the analyses comparing the antioxidant effects of EPA, DHA, mineral oil, and corn oil should help advance the medical community’s understanding of the role and value of VASCEPA and EPA to reduce cardiovascular events in an at-risk patients globally. We remain committed to investing in our data and our medical presence with a global focus to support the medical education efforts for the launches of VASCEPA, VAZKEPA around the world.

With that, I’ll turn it over to Tom to talk more about our progress and strong results this quarter. Tom?

Tom Reilly: Thank you, Karim. Good morning, everyone. I’m pleased to report additional details on our financial performance for the fourth quarter and full year 2022 following our pre-announcement in January. Let me begin by discussing our revenue performance, for the fourth quarter of 2022. We reported total net revenue of $90.2 million, including net product revenue of $89.5 million, a decrease of 38% compared to the fourth quarter of 2021. U.S. product revenue was $88 million in line with a third quarter of 2022, reflecting relatively stable trend in volume. We remain pleased the stable trends in spite of multiple competing generics on the market. The U.S. business continues to generate a positive contribution margin and provides necessary financial support for expansion in Europe and other geographies around the world.

The results included international product revenue of $1.5 million, which includes European product revenue of $0.3 million, beginning to reflect very early revenues from the UK. Cost of goods sold for the three months ended December 31st, 2022 was $26.6 million compared to $30.6 million in the corresponding period of 2021. Gross margin was 70.3% for the three months ended December 31st, 2022, compared to 78.7% in Q4 2021, as a result of lower U.S. net selling price. Now moving on to operating expenses. During the fourth quarter of 2022, we reported the expenses of $73.2 million compared to $97.7 million in the fourth quarter of 2021. It decreased at $24.5 million or 25%. The decrease compared to last year includes the impact of the cost saving initiative announced in June of 2022.

These savings were partially offset by our investments in growth and expansion in Europe. Under U.S. GAAP Amarin reported net income of $0.9 million for the fourth quarter 2022 for basic and diluted loss per share of zero. As of December 31st, 2022. Amarin reported aggregate cash and investments of $310.6 million in demonstrating the cash positive for quarter of 2022. We continue to experience relatively stable trends in our US business. Currently, we are not seeing any significant impact from Teva’s listing on a one-gram generic version of the CFA. We do expect our US revenues for the first quarter 2023 to reflect the impact of typical brand branded seasonality resulting in first quarter revenues slightly lower than the fourth quarter. We do expect the year to reflect continued pressure on both prescriptions and also price as we work the retain key customers to the brand.

We’ve continued to make progress against our cost reduction program announced in June of 2022, and we are on track to exceed the $100 million cost savings target we announced in mid-2022. For the full year of 2023, we now expect the operating expenses to be between $290 million to $305 million compared with approximately the $350 million originally anticipated at the time of our June 2022 cost savings announcement. The lower than anticipating expenses are result of additional initiatives taken across the organization to reduce costs, along with the timing of our European investments, where we committed to invest carefully in Europe ahead of reimbursement decisions. Since the cost savings announcements in June, we have taken significant steps this year to strengthen and streamline the company operationally.

In addition, we have made significant progress amending our supply agreements and those negotiations are still ongoing. With these initiatives and relatively stable trends in the US, we believe our current available cash and resources, including US profitability are adequate to support continued operations, including European launch activities. Now, with that, I will turn the call back to Karim for closing remarks. Karim?

Karim Mikhail : Thank you, Tom, for that financial overview and our results during the fourth quarter. We exited 2022 with a strong foundation to support our future growth plans as we focus on becoming global diversified cardiometabolic layer, and we are off to a strong start in 2023. We have a very clear set of priorities. Our first and main objective is to conclude reimbursement discussion successfully in the remaining European markets and launch. We will do this while remaining laser focused on our cash preservation efforts. We’re just beginning to see the results of our efforts over the last 18 months. Gaining pricing and reimbursement in Europe remains critical for a strong sustainable future and shareholder value creation.

We would also like to take a moment to address Amarin’s General Meeting that was held yesterday, the results of which were disclosed after market closed. On behalf of the Amarin board and management team, we would like to thank all of our shareholders for their engagement and feedback throughout this process. Continuing to enhance our shareholder engagement program across our broad investor base remains a key priority as we move through this year and beyond. 2023 is a critical year for Amarin as we continue pricing and reimbursement negotiations. We are in the process of transitioning to F15 member board, including the onboarding of all new members to ensure that the company remains focused on progressing against our strategic objectives to deliver enhanced value for shareholders.

I would like to take this opportunity to thank for his leadership, dedication, and counsel during his role as Chairman of the Emirates Board. The board expects to appoint a new Chairman in due course. I would also like to commend our employees across the organization for their steadfast hard work, focus and commitment to Amarin. Finally, I hope we provided our shareholders with clear details of our fourth quarter and full year earnings results. And with that, operator, we are ready to take questions.

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Q&A Session

Operator: Certainly. . Your first question for today is coming from Michael Yee at Jefferies.

Unidentified Analyst : Hi. Good morning. This is Jocelyn on the line for Mike Yee. Thanks for taking my question. I guess I have two. First, on your UK launch, the access data you shared looks very promising. So how do you see the access you have in the UK could translate to your product sales? And do you plan to break out European sales in your future reporting? And secondly, on Germany, I think you have mentioned that, you plan to submit another dossier to Germany. Maybe remind us what the process looks like and how we should think about the timeline? Thank you.

Karim Mikhail: Thank you for the question. I’ll start with the UK launch. So, as you have seen, it is difficult that any company by the way shares very specific metrics of a country launch. We decided to do that since UK is one of our first big market launches and we believe that there is value for shareholders to stay very close to these metrics. What we have presented today is showing the formulary listing, which is really the most important step to opening the door for physicians to prescribe for the product. It demonstrates that, the product availability is real for a very large majority of patients. Now in terms of future results, we will try as much as possible to share more metrics hopefully also from a revenue perspective at the right moment.

Having said that, a breakout of reporting between countries in Europe is not a very customary thing, and I think would not help us honestly in terms of negotiating prices and maintaining proper working relationship with the reimbursement agencies. But our intent is to share as much as possible, especially on the UK as the first country launch. For Germany resubmission, yes, this is the plan to go back to Germany, because we believe that the German patients deserve to use VASCEPA. But we believe, the timing for this would have better chances of success after other large markets approving the product. So, once we have Spain, Italy, France, it will probably be a better time to submit the file. And at that point in time, we will have a stronger associate to submit.

But thank you for the question. We are not giving up on Germany. We will keep trying.

Unidentified Analyst : Thank you. That’s very helpful. Thank you so much.

Operator: Your next question is coming from Roanna Ruiz at SVB Securities.

Roanna Ruiz: Hi. Good morning everyone. So, wanted to check-in about the U.S. a little bit. So, what’s your level of confidence in your inclusive contracts holding up this year, and do you expect revenue stabilization to continue through most of 2023?

Karim Mikhail: Thank you, Roanna. So, on the U.S. if you remember, the exclusive journey started really in July of 2021. So, this is not something that the team started working on this last quarter. Over the last 18 months, we were able to sustain our volume from the exclusive stable over six quarters. So, there’s definitely a very solid foundation, but we are in an open market where there is competition. Now we have a fourth entrance which listed, but is not yet available on the market. So, we feel confident that the foundation that we have established is stable. We already communicated in our comments that we’re going to see some erosion on the price. We’re going to see a typical erosion on volume that we’ve seen quarter-over-quarter.

And we’re ready for multiple scenarios. If we have from the beginning — assume that this market is going to act like a typical generic market and we’re going to lose 90% of the business by now, we would not have sold the $1 billion that we sold. So, we continue to keep four fingers on the pulse. We stay very close, for the moment the situation is stable. We have not lost any of these exclusive, we are in a stable position. But if there are threats, we have a plan and we will act swiftly on this plan if need be to maintain U.S. profitability.

Roanna Ruiz: Got it. Thanks for clarifying. So, I wanted to also ask about Europe a little. So, I think on the call you mentioned Italy might have a reimbursement decision mid-year and France and Spain may possibly come online to, so I was curious, will you be ready to immediately launch in these regions after getting decisions or just curious what the rollout might look like for VAZKEPA there.

Karim Mikhail : Yes. So first of all, let me clarify. I mean, you mentioned three countries. Those three countries are very different processes and very different timelines. So, in Spain, we try to be as clear as possible that we’ve had two rounds of negotiation. We are starting a third round of negotiations. So, this is imminent as we described it, at least based on where we are in terms of negotiation. Italy, the process is less structured and the way it’s progressing current estimation is maybe by mid-year, France usually takes longer time, right? In terms of arriving to an agreed upon price. But in those three markets, the minute we’re going to have reimbursement, we will be ready for launch. And those markets differ in Spain, you have a lot of sort of regional market access, which by the way, we have also made progress with just to ensure we are ready to launch when we have a Spanish price.

In France, it’s a very nationally driven system. So, there are no regional access hurdles. So, the minute we’re going to have a French price, we’re going to be launching to really the major primary care population, and it’s a significant market, but France takes longer time based on benchmarks that we have. So, we’re working on the three of them.

Roanna Ruiz: Understood. Thanks a lot.

Operator: Your next question for today is coming from Louise Chen at Cantor.

Louise Chen : Hi. Thanks for taking my question. So, I wanted to ask you how committed you are to sustain cashflow breakeven, and how feasible is that given generics and also incremental burn with each new European approval?

Karim Mikhail: Thank you, Louise. So, 2022, we had a very clear vision to turn around the cash burn situation from the $100 million to the cash flow positive that you’ve seen. Now we’re entering a different phase, right? Because we have a number of milestones that we are going to have in 2023, especially with European launches. With those European launches, there will be an necessity to invest. So, the situation will change quarter to quarter, but there are also other variables that impact our cash flow and let to maybe talk more about that.

Tom Reilly: Yeah. So overall, cash flow — overall, our guidance is that we have enough cash, and cash equivalents to get to profitability to support the European launches. What we expect is for 2023, depending on the situation, what we expect is that we will have a decline in cash balance. There’s going to be ebbs and flows between particular quarters, right? And so, it’s — so we will not be coming in cash positive every quarter, but more of an ebbs and flows. As should recall, we took specific initiatives last year on the supply chain. We still have negotiations taking place and the cost savings initiatives as well.

Karim Mikhail: And of course, you’ve heard us delivering above plan in terms of OpEx and the savings, which is significant number. And big part will also depend on the stabilization of the US. So, we are very clear on what are the key drivers of maintaining our cash position, whether it is the US business, our level of OpEx, which we are making far more additional efforts to try to save money. But if we’re going to spend a bit more, it’ll be good news because it means we have more European markets that are joining the launch phase. It’s important to note that a lot of our European expenses are already built in and bake within these numbers, right? So, you’ve seen on some of our slides, we talk about overall headcount in Europe today in the range of 200, which is basically saying we have recruited a significant number in all those markets where we’re launching. We are well equipped. So hopefully that will answer your question Louise.

Louise Chen: Yes, thank you.

Operator: Your next question is coming from Cade Cruz at Goldman Sachs.