Q2 2025 Amarin Corp PLC Earnings Call

Conference over to Mr. Mark Murmur.

Operator: I would now like to turn the conference over to Mr. Mark Marmur, Vice President, Corporate Communications and Investor Relations at Amarin. Sir, the floor is yours.

Rice, President corporate communications and Investor Relations of Amarin, Sir the floor is yours.

Good morning, everyone and thank you for joining US. Please be aware. 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.

Mark Marmur: 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 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.

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 for terminated.

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, 2024, and the quarterly report on Form 10-Q for the <unk>.

Mark Marmur: 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 31 December 2024, and the quarterly report on Form 10-Q for the quarter ended 30 June 2025, which have been filed with the SEC and are 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, Aaron Berg, Amarin's President and Chief Executive Officer, will provide an update on the state of our business and operational progress, and Peter Fishman, Amarin's Chief Financial Officer, will review our Q2 2025 financial results. Following these prepared comments, there will be a question and answer session.

<unk> ended June 32025, which has been filed with the SEC and are available through the Investor Relations section of our website at Www Dot Ameren Corp. Dot com, we encourage everyone to read these documents.

An archive of this call will be posted on <unk> website in the Investor Relations section.

Turning to today's agenda, Aaron Berg, <unk>, President and Chief Executive Officer, who will provide an update on the state of our business and operational progress and peak Fischer.

<unk> Chief Financial Officer will review, our second quarter 2025 financial results.

Following these prepared comments there will be a question and answer session.

With that I'll turn the call over to Aaron Berg, President and Chief Executive Officer of Amarin Aaron.

Mark Marmur: With that, I will turn the call over to Aaron Berg, President and Chief Executive Officer of Amarin. Aaron?

Thank you Mark good morning, everyone and thank you for joining US today Q2, 2025 was a pivotal quarter for amarin, Mark by decisive strategic actions at steady operational progress.

Aaron Berg: Thank you, Mark. Good morning, everyone, and thank you for joining us today. Q2 2025 was a pivotal quarter for Amarin, marked by decisive strategic actions and steady operational progress. Two significant strategic actions marked a pivotal shift for the company. First, we entered into a long-term licensing and supply agreement with Recordati, intended to accelerate commercialization for VASCEPA across Europe. Partnering with Recordati will build on our early efforts to drive the commercialization of VASCEPA in this important growth market. Our core franchise will now be in the hands of a partner with significant cardiovascular experience, established infrastructure, and the resources to build on the progress our team has achieved in the region, in particular related to market access, scientific support, and initial commercial launch results.

Two significant strategic actions marked a pivotal shift for the company.

First we entered into a long term licensing and supply agreement with record Audi intended to accelerate commercialization for <unk> across Europe.

Partnering with record Audi will build on our early efforts to drive the commercialization of a step up in this important growth market.

Our core franchise will now be in the hands of a partner with significant cardiovascular experience.

Stablish infrastructure and the resources to build on the progress our team has achieved in the region in particular related to market access scientific support an initial commercial launch results.

We expect that to this partnership.

Aaron Berg: We expect that through this partnership, VASCEPA patient penetration in Europe will increase, resulting in benefits for the company and shareholders through the structured royalty stream as well as the sales milestones under the licensing agreement. In conjunction with the European partnership, we further right-sized our global organization, which will result in anticipated OpEx savings of approximately $70 million over the next 12 months. As we continue to operate in an increasingly efficient manner, we'll focus our resources on contributing to the success of our global partners as they drive growth. Our financial results this quarter reflect the steady operational progress we were making with our business. We delivered solid product sales growth in Europe and other key markets in the rest of the world, both year over year and sequentially, while managing our expenses tightly, as we've consistently done over recent years.

<unk> patient penetration in Europe will increase resulting in benefits for the company and shareholders to the structured royalty stream as well as the sales milestones under the licensing agreement.

In conjunction.

So with the European partnership.

We further right size, our global organization, which will result in anticipated operating expense savings of approximately $70 million over the next 12 months.

As we continue to operate in an increasingly efficient manner, we will focus our resources on contributing to the success of our global partners as they drive growth.

Our financial results this quarter reflect the steady operational progress, we're making with our business we.

We delivered solid product sales growth in Europe, and other key markets in the rest of the world both year over year and sequentially, while managing our expenses tightly and we've consistently done over recent years.

These significant steps better position us to maximize the global potential for Vascepa and drive increased shareholder value powered by the following key foundational strengths.

Aaron Berg: These significant steps better position us to maximize the global potential for VASCEPA and drive increased shareholder value powered by the following key foundational strengths. Number one, VASCEPA is a proven treatment to reduce cardiovascular risk, supported by robust clinical evidence, including the landmark REDUCE-IT study, which demonstrated a 25% reduction in major adverse cardiovascular events when icosapent ethyl is added to statin therapy. This science is matched with ever-growing support from key opinion leaders, evidenced by endorsement from more than 50 medical societies worldwide due to its proven efficacy and safety profile, and the increasing recognition that VASCEPA is a complement to current therapies available today for physicians addressing the cardiovascular risk in their patients. This recognition by the global scientific community of the significance of the REDUCE-IT data has helped deliver regulatory approvals in 50 countries globally as an effective treatment for cardiovascular risk reduction.

Number one the SIPA is a proven treatment to reduce cardiovascular risk supported by robust clinical evidence, including the landmark reduce it study, which demonstrated a 25% reduction in major adverse cardiovascular events. When <unk> is added to statin therapy.

This science is matched with ever growing support from key opinion leaders evidenced by endorsement for more than 50 medical societies worldwide due to its proven efficacy and safety profile and the increasing recognition that vascepa is a complement to current therapies available today for physicians.

Dressing the cardiovascular risk and their patients.

This recognition by the global scientific community of the significance of the reduce it data has helped deliver regulatory approvals in 50 countries globally as an effective treatment for cardiovascular risk reduction.

Number two we have a global business with multiple efficient revenue streams across the U S as well as the partner markets of Europe, and the rest of the world.

Aaron Berg: Number two, we have a global business with multiple efficient revenue streams across the US as well as the partner markets of Europe and rest of the world. Number three, we have a strong financial foundation built on a significantly reduced and substantially more efficient operating model, combined with a sound balance sheet of nearly $300 million in cash, zero debt, and on-hand inventory levels sufficient to meet global demand, all of which put us on an accelerated path to positive cash flow.

And number three we have a strong financial foundation built on a significantly reduced and substantially more efficient operating model combined with a sound balance sheet of nearly $300 million in cash zero debt and on hand inventory levels sufficient to meet global demand.

All of which put us on an accelerated path to positive cash flow.

Now regarding operational progress on our second quarter results, we continued to make meaningful progress across our global operations with our enhanced partnering efforts, playing a central role in driving growth and expanding access to vascepa worldwide.

Aaron Berg: Now, regarding operational progress and our Q2 results, we continue to make meaningful progress across our global operations with our enhanced partnering efforts playing a central role in driving growth and expanding access to VASCEPA worldwide. While the US remains foundational to our business, I'd like to focus on the progress we're seeing across Europe and in our rest of world markets, where through our partnerships, we continue to expand access to VASCEPA for patients in need. To start, I'll talk about Europe. As a result of the tremendous efforts of our team, access and demand for VASCEPA have been building in the region. During the quarter, in-market demand increased 17% from Q1 2025, a healthy indicator of growing momentum on a sequential basis.

While the U S remain foundational to our business I'd like to focus on the progress we're seeing across Europe, and our rest of the world markets, where through our partnerships. We continue to expand access to vascepa for patients in need.

To start I will talk about Europe.

As a result of the tremendous efforts of our team access and demand for <unk> had been building in the region.

During the quarter in market demand increased 17% from Q1 2025, a healthy indicator of growing momentum on a sequential basis.

Through the first six months of this year in market demand grew 132% versus the first six months of 2024, largely from Spain, and the UK, which continue to drive the majority of uptake and revenue in Europe.

Aaron Berg: Through H1 of this year, in-market demand grew 132% versus H1 2024, largely from Spain and the UK, which continue to drive the majority of uptake and revenue in Europe. In Italy, a key market, our team has been focused on expanding regional access, a critical step to prepare the market for uptake upon launch. We've now secured reimbursement in most local regions, representing over 91% of the total eligible patients, particularly in high-density areas, a positive sign of market interest. As mentioned, our recent partnership with Recordati strengthens our ability to capitalize on this early progress with VAZKEPA and leverages Recordati's cardiovascular expertise and commercial scale to accelerate utilization in Europe. We are focused on rapidly transitioning the business to Recordati, which we expect to be largely completed by the end of 2025.

In Italy, our key market.

Our team has been focused on expanding regional access a critical step to prepare the market for uptake upon launch.

We've now secured reimbursement in most local regions representing over 91% of the total eligible patients, particularly in high density areas a positive sign of market interest.

As mentioned, our recent partnership with record Avi strengthens our ability to capitalize on this early progress with Vascepa and Leverages record <unk> cardiovascular expertise in commercial scale to accelerate utilization in Europe.

We are focused on rapidly transitioning the business to record audience, which we expect to be largely completed by the end of 2025.

Both teams are working exceptionally well together and were impressed with how passionate and knowledgeable the record Audi team is above our skipper and its benefits for patients.

Aaron Berg: Both teams are working exceptionally well together, we're impressed with how passionate and knowledgeable the Recordati team is about Vascepa and its benefits for patients. Turning to the rest of the world markets. Our partners are focused on driving patient uptake through the tremendous value and potential for Vascepa in their respective markets and continue to make progress in commercialization or regulatory process locally. In China, our partner, EddingPharm, is pursuing their commercialization efforts focused on post-PCI patients in top-tier private hospitals through the self-pay market. This strategy is delivering strong in-market demand growth with 68% growth versus Q1 2025, leading to strong revenue and profitability, and is anticipated to meet current internal growth targets. With an estimated 330 million cardiovascular patients and one of the highest CVD mortality rates globally, China continues to represent a significant long-term opportunity for Amarin.

Now turning to the rest of the World markets are partners are focused on driving patient uptake through the tremendous value and potential for vascepa in their respective markets and continued to make progress in commercialization or regulatory process locally.

In China, our partner, adding farm is pursuing their commercialization efforts focused on post PCI patients and top tier private hospitals to the self pay market.

This strategy is delivering strong end market demand growth with 68% growth versus the first quarter of 2025, leading to strong revenue and profitability and is anticipated to meet current internal growth targets.

With an estimated 330 million cardiovascular patients and one of the highest CVD mortality rates globally, China continues to represent a significant long term opportunity for amarin.

In Australia, our partner CSL secures is executing a thoughtful launch strategy focused on recent Acs patients.

Aaron Berg: In Australia, our partner CSL Seqirus is executing a thoughtful launch strategy focused on recent ACS patients. Since January, CSL has seen steady in-market demand growth with 75% growth in Q1 2025 versus Q4 2024, the most current period where data is available. This is supported by a strong scientific foundation and a target population of approximately 1.3 million Australians with established cardiovascular disease. In Canada, our partner HLS Therapeutics continues to deliver volume growth with 31% month-over-month growth as of May. HLS also recently secured a product listing agreement with Nova Scotia Pharmacare, effective 1 July 2025. We expect this will expand public reimbursement and access to Vascepa across the Canadian market. Our partner Biologix FZCo reported strong volume growth across the Middle East and North Africa markets, with 62% growth versus Q1 2025, driven primarily by Saudi Arabia.

Since January CSL has seen steady end market demand growth with 75% growth in the first quarter of 2025% versus the fourth quarter of 2020 for the most current period, where data is available.

This is supported by a strong scientific foundation and a target population of approximately $1 3 million Australians with established cardiovascular disease.

In Canada, our partner <unk> Therapeutics continues to deliver volume growth with 31% month over month growth as of May <unk>.

<unk> also recently secured a product listing agreement with Nova Scotia Pharma care effective July one 2025, we expect this will expand public reimbursement and access to vascepa across the Canadian market.

Our partner Biologics reported strong volume growth across the middle East and North Africa markets with 62% growth versus the first quarter of 2025% driven primarily by Saudi Arabia.

And in Southeast Asia, our partner Lotus and established company with significant in reaching capabilities is advancing regulatory and pricing and reimbursement processes across southeast Asia.

Aaron Berg: In Southeast Asia, our partner Lotus, an established company with significant in-region capabilities, is advancing regulatory and pricing and reimbursement processes across Southeast Asia. Recently, South Korea granted regulatory approval for VASCEPA, taking us to 50 markets globally where VASCEPA has been approved for cardiovascular risk reduction. The product is now progressing through the pricing and reimbursement phase in South Korea, which is expected to take approximately a year. The success of our partners in Europe and rest of world is critical to our global strategy of making VASCEPA available to the millions of patients in need of cardiovascular risk reduction, including the nearly 8 million patients in Europe with established cardiovascular disease. All of our partners are demonstrating great capabilities and focus to support the continued expansion of VASCEPA. Lastly, a few comments about the US business, still the core contributor of revenue for the company.

Recently, South Korea granted regulatory approval for Vascepa, taking us to 50 markets globally, where vascepa has been approved for cardiovascular risk reduction.

The product is now progressing through the pricing and reimbursement phase in South Korea, which is expected to take approximately a year.

The success of our partners in Europe, and rest of World is critical to our global strategy of making vascepa available to millions of patients in need of cardiovascular risk reduction, including the nearly 8 million patients in Europe with established cardiovascular disease.

All of our partners are demonstrating great capabilities and focus to support the continued expansion of the CFO.

Lastly, a few comments about the U S business still a core contributor of revenue for the company.

We sustained the vascepa franchise for more than four years. After the introduction of the first generic product in the U S.

Aaron Berg: We've sustained the VASCEPA franchise for more than 4 years after the introduction of the first generic product in the US. Thanks to the dedication of our team, we retained all major exclusive accounts through Q2 2025, our market share remained stable at 43% at quarter end, delivering meaningful revenue and profit contributions that continue to form the foundation of US product sales and margin. As we noted previously and have experienced in prior years, we typically observe prescription volume declines in Q1, followed by volume growth in Q2. This was the case for Q2 2025, where we saw volumes increase by 7% sequentially. Looking ahead, while we expect continued year-over-year revenue declines, we remain focused on maximizing value from the US market through smart, efficient, and targeted commercial execution. Pricing pressure remains volatile, and it's still too early to make predictions for 2026.

Thanks to the dedication of our team we've retained all major exclusive accounts through Q2, 2025, and our market share remains stable at 43% at quarter end delivering meaningful revenue and profit contributions that continue to form the foundation of U S product sales and margin.

As we noted previously and have experienced in prior years, we typically observe prescription volume declines in the first quarter, followed by volume growth in the second quarter.

This was the case for Q2, 2025, where we saw volumes increase by 7% sequentially.

Looking ahead, while we expect continued year over year revenue declines we remain focused on maximizing value from the U S market through smart efficient and targeted commercial execution.

Pricing pressure remains volatile and it's still too early to make predictions for 2026.

That said, we are prepared to launch our authorized generic weren't optimal as part of our ongoing product lifecycle management approach.

Aaron Berg: That said, we are prepared to launch our authorized generic when optimal as part of our ongoing product lifecycle management approach. In summary, our US business remains a significant cash generator almost 5 years post-generic entry. We're encouraged by the collaborative efforts to ensuring the success of all our partners with the knowledge and support they need to maximize the brand's global potential. To conclude, let me end with the following. Amarin today is in a far different and healthier position. We've executed a plan to partner out a key growth market while implementing an even leaner global operating footprint. With these actions, I'm confident that we're well-positioned to deliver value for shareholders.

In summary, our U S business remains a significant cash generator almost five years post generic entry the European business in rest of World partnerships continued to build momentum and we're encouraged by the collaborative efforts to ensuring the success of all our partners with the knowledge and support they need to maximize the brand's globe.

<unk> potential.

To conclude let me end with the following.

<unk> today is in a far different and healthier position, we've executed a plan to partner out a key growth market, while implementing an even leaner global operating footprint with.

With these actions I am confident that we are well positioned to deliver value for shareholders.

In addition, as mentioned previously we're actively working with Barclays has our exclusive financial advisor to evaluate further potential strategic opportunities to capitalize on the inherent value of amarin and increase shareholder value.

Aaron Berg: As mentioned previously, we're actively working with Barclays as our exclusive financial advisor to evaluate further potential strategic opportunities to capitalize on the inherent value of Amarin and increase shareholder value. There's no defined timeline for this initiative, as we'll take the necessary time to carefully evaluate the best options, we'll keep you informed should any material developments arise. Overall, this phase of the company's evolution is focused on capitalizing on our strengths financially, operationally, strategically, we're poised to efficiently and urgently drive the pace and scope of patient uptake across the key growth markets in Europe and the rest of world, all driven by an unwavering commitment to our core mission to maximize the global potential of the Vascepa franchise. With that, I'll turn it over to Peter Fishman, our Chief Financial Officer, to walk through the financial results for Q2. Peter?

No defined timeline for this initiative as we will take the necessary time to carefully evaluate the best options and we'll keep you informed should any material developments arise.

Overall this phase of the company's evolution is focused on capitalizing on our strengths financially operationally and strategically and we're poised to efficiently and urgently drive the pace and scope of patient uptake across the key growth markets in Europe, and the rest of the world.

All driven by an unwavering commitment to our core mission to maximize the global potential of the Vascepa franchise.

With that I'll turn it over to Pete Fishman, our Chief financial Officer to walk through the financial results for the second quarter.

Thank you Erin turning to the financial results Q2, 2025 total net revenue was $72 7 million, an increase of $5 3 million or 8% versus the prior year period, primarily reflecting the impact of the record <unk> upfront payment.

Peter Fishman: Thank you, Aaron. Turning to the financial results. Q2 2025 total net revenue was $72.7 million, an increase of $5.3 million, or 8%, versus the prior year period, primarily reflecting the impact of the Recordati upfront payment. Q2 2025 net product revenue was $46.6 million, a 2% decrease primarily driven by lower net selling price in the US, which was almost entirely offset by growth in Europe and rest-of-world markets, an important indication of the potential impact these ex-US markets can have on our overall performance as we continue to manage the generic environment in the US. As for the US business, Q2 2025 net product revenue was $36.5 million, a decline of 17% reflecting the continued pricing pressure from generics.

Q2, 2025 net product revenue was $46 6, million% to 2% decrease primarily driven by lower net selling price in the U S, which was almost entirely offset by growth in Europe and rest of world markets.

An important indication of the potential impact is ex U S markets can have on our overall performance as we continue to manage the generic environment in the U S.

As for the U S business Q2, 2025, net product revenue was $36 5 million a decline of 17%, reflecting the continued pricing pressure for generics.

Volumes in the quarter rebounded compared to Q1 as expected following normal course seasonality and the U S team continues to deliver material contributions from this business despite ongoing persistent headwinds.

Peter Fishman: Volumes in the quarter rebounded compared to Q1, as expected, following normal core seasonality, and the US team continues to deliver material contributions from this business, despite ongoing and persistent headwinds. In addition, a large national payer moved VASCEPA back to exclusive status as of 1 July. We have seen our market share increase to approximately 50% in July, which we believe is likely due to this change. This reflects our continued commitment to compete on price to maintain VASCEPA's market leadership. Because of pricing dynamics in the market, we do not anticipate that this change will have a material impact on overall profitability. In Europe, Q2 2025 product revenue reached USD 6.6 million, almost double the prior year period and continuing the trend of quarterly in-market demand growth across all launch markets. Consistent with recent quarters, Spain and the UK continued to be the largest contributors.

In addition, a large national payer move vascepa back to exclusive status as of July <unk>.

We have seen our market share increased to approximately 50% in July which we believe is likely due to this change.

This reflects our continued commitment to compete on price to maintain vascepa as market leadership.

Because of pricing dynamics in the market, we do not anticipate that this change will have a material impact on overall profitability.

In Europe, Q2, 2025 product revenue reached $6 6 million almost double the prior year period, and continuing the trend of quarterly end market demand growth across all launched markets.

Consistent with recent quarters span in the UK continues to be the largest contributors.

As commercialization moves to record audience, we should expect patient access to the step up throughout Europe to expand.

Peter Fishman: As commercialization moves to Recordati, we should expect patient access to VAZKEPA throughout Europe to expand. We look forward to reporting on this evolving opportunity over subsequent quarters. In rest-of-world markets, Q2 2025 product revenue was $3.5 million, significantly higher than the prior year period and driven by partner purchases, indicating that market access for our group of partners across this diverse segment is expanding. As a reminder, rest-of-world revenue will remain variable quarter to quarter based on launch timing, in-market demand, and the structure of individual partnership agreements. We remain confident that over time, growth will build across our partnered markets. Q2 2025 licensing and royalty revenue was $26.1 million, up 31% from the prior year period, clearly reflecting the impact of the upfront payment from Recordati as well as in-market demand driven by our partners.

We look forward to reporting on this evolving opportunity over subsequent quarters.

And rest of World markets Q2, 2025 product revenues was $3 5 million significantly higher than the prior year period, and driven by our purchases, indicating that market access for our group partners across this diverse segment did expand.

As a reminder, our rest of world revenue will remain variable quarter to quarter based on launch timing and market demand and the structure of individual partnership agreements.

We remain confident that over time growth will build across our partner markets.

Q2, 2025 licensing and royalty revenue was $26 1 million up 31% from the prior year period, clearly, reflecting the impact of the upfront payment from record audience as well as end market demand driven by our partners.

Overall, the state of our revenue generation in the quarter indicates momentum in the growth segments of our business, while continuing to realize profitable revenue as we manage the mature U S business.

Peter Fishman: Overall, the state of our revenue generation in the quarter indicates momentum in the growth segments of our business while continuing to realize profitable revenue as we manage the mature US business. Turning to expenses, let me begin with reminding everyone that in parallel with the Recordati licensing agreement, we initiated a global restructuring where we recognized expenses during Q2 and will continue to incur expenses throughout the rest of the year. This action will result in an estimated $70 million in OpEx savings over the next 12 months, a significant change in our operational footprint and cost structure needed to support the brand globally and run a public company. Q2 2025 SG&A and R&D were $38.7 million and $4.9 million respectively, consistent with the prior year period.

Turning to expenses, let me begin with reminding everyone that in parallel with the record on a licensing agreement we initiated a global restructuring where we recognized expenses during Q2 and will continue to incur expenses throughout the rest of the year.

This action will result in an estimated $70 million and operating expense savings over the next 12 months a significant change in our operational footprint and cost structure needed to support the brand globally and run a public company.

Q2, 2025, SG&A and R&D were $38 7 million and $4 9 million, respectively, consistent with the prior year period.

Our operating expenses continue to reflect our disciplined expense management and do not yet reflect savings from the recently announced restructure.

Peter Fishman: Our operating expenses continue to reflect our disciplined expense management and do not yet reflect savings from the recently announced restructure. Q2 2025 cost of goods sold was $22.4 million, a decrease of $2.3 million or 9% over the prior year period. Now turning to the balance sheet. We ended the quarter with $298.7 million in cash and investments and no debt. We continue to focus on cash preservation and growth for the future, and the strategic actions we've taken will result in significant progress in these efforts. Importantly, our on-hand inventory is sufficient to meet global demand, and we have a robust global supply chain that will enable us to continue to support and supply our partners as market demand grows throughout the world.

Q2, 2025 cost of goods sold was $22 4 million, a decrease of $2 3 million or 9% over the prior year period.

Now turning to the balance sheet, we ended the quarter with $298 7 million in cash and investments and no debt. We continue to focus on cash preservation and growth to the future and the strategic actions. We've taken will result in significant progress in these efforts.

Importantly, our on hand inventory is sufficient to meet global demand and we have a robust global supply chain that will enable.

<unk> us to continue to support and supplier partners as market demand grows throughout the world.

In summary, our Q2 2025 results reflect the resiliency in our U S business as well as initial indications of growing steady momentum and its still vastly underserved global marketing outside the U S. Operationally, we are sufficiently capitalized to finance our operations as we continue.

Peter Fishman: In summary, our Q2 2025 results reflect the resiliency in our US business, as well as initial indications of growing steady momentum in the still vastly underserved global market outside the US. Operationally, we are sufficiently capitalized to finance our operations as we continue to progress on an accelerated path to positive cash flows. With that, I'll turn the call back over to Aaron for closing remarks. Aaron?

Progress on an accelerated path to positive cash flows.

And with that I'll turn the call back over to Aaron for closing remarks, Eric.

Thanks, Pete in closing, let me finish with the following week.

Aaron Berg: Thanks, Pete. In closing, let me finish with the following. We've taken steps to better position the company to realize its mission. We monetize the European market after putting in place a substantial base to build off of. VAZKEPA is now in the hands of a proven partner in Europe. By putting in place yet another contributor to our royalty-based revenue foundation, combined with the other partners across the globe, coupled with a significant restructuring, and further complemented by our continued maintenance of the mature US market, all of this combines to putting us on a path to eventual growth and positive free cash flow. The timing of realizing these value-creating elements is not yet clear. Rather, at a minimum, we've taken the right steps to put in place a means by which they can be realized, and we must continue to execute globally.

We've taken steps to better position the company to realize mission.

We monetize the European market after putting in place a substantial base to build off of.

The skipper as now in the hands of a proven partner in Europe.

By putting in place yet another contributor to our royalty based revenue foundation combined with the other partners across the globe.

Coupled with the significant restructuring and further complemented by our continued maintenance of the mature U S market.

All of this combines to putting us on a path to eventual growth and positive free cash flow.

The timing of realizing these value, creating elements is not yet cleared.

Rather at a minimum we've taken the right steps to put in place a means by which they can be realized and we must continue to execute globally.

In short this is a pivotal time for the company and we wouldn't be in this position without the dedication of our employees and partners around the world. So thank you. Your dedication continues to make a meaningful difference in the lives of patients every day.

Aaron Berg: In short, this is a pivotal time for the company, and we wouldn't be in this position without the dedication of our employees and partners around the world. Thank you. Your dedication continues to make a meaningful difference in the lives of patients every day. With that, we'll get started with Q&A. Operator?

And with that we will get started with Q&A operator.

Okay.

Banking at this time, we'll be conducting a Q&A session.

Operator: Thank you. At this time, we'll be conducting our Q&A session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue, and you may press star two if you would like to remove your question from the queue. 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. Thank you. Our first question is coming from Paul Choi with Goldman Sachs. Your line is live.

I'd like to ask a question. Please press star one on your telephone keypad comp.

A confirmation tone will indicate your line is in the question queue. You May Press Star two if you would like to remove your question from the queue.

Participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

One moment, please where we pull for questions.

Thank you.

Our first question is coming from Paul Choi with Goldman Sachs. Your line is live.

Hi, Thank you good morning, and thank you for taking our questions.

Paul Choi: Hi. Thank you. Good morning, and thank you for taking our questions. My first question is, can you maybe just update us on how you're thinking about your formulary negotiations in the US and potential changes for 2026? Anything that you would call out that we should be mindful of as we think about how your US trajectory might look like and the role of potential authorized generic, and how that figures in your 2026 strategy. My second question is, now with the Recordati partnership signed, can you maybe just share with us what sort of metrics you're going to provide to the street so we can just monitor progress and how you plan to benchmark that? Thank you very much for taking our questions.

My first question is can you maybe just update us on how youre thinking about.

Your formulary negotiations in the U S and potential changes for 2020 anything that you would call out that we should be mindful of as we sort of think about how your.

U S.

Factory might look like and the role of.

Potential authorized generic and how that figures in your 26 strategy and.

And my second question is.

And now with the record that a partnership signed can you maybe just share with us what sort of metrics you're going to provide to the street. So we can just sort of monitor progress on how you plan to benchmarks that thank you very much for taking our questions.

Thanks, Paul I appreciate the question so for the first question around the U S business.

Aaron Berg: Thanks, Paul. Appreciate the question. For the first question around the US business, we've continued to maintain our exclusives in 2025. We anticipate that we'll maintain those exclusives through the rest of 2025. We'll have further clarity on 2026 as we get toward the end of the year. In terms of the AG, we've been prepared, and we've stated this a number of times. We've been prepared to launch an AG when the time is optimal. That time is not yet because we've been able to compete very well with the branded products, maintain our volume, maintain the volume profitably in the US. As you know, if you launch an AG, it will further erode the brand.

We've.

Continued to maintain our exclusives and 2025, we anticipate that we will maintain those exclusives to the rest of two.

2025, we will have further clarity on 2026 as we get.

Towards the end of the year.

In terms of.

The AG.

<unk> been prepared and we've stated this number of times, we've been preparing to launch an AG. When the time is optimal at that time is not yet because we've been able to compete very well with the branded products maintain our volume maintain the volume profitably and.

In the U S and as you know if you're launching AEG. It will further erode the brand. So it's right now it's in our best interest to continue with the brands, but we'll be ready.

Aaron Berg: Right now it's in our best interest to continue with the brand, but we'll be ready to launch the AG, and that's based on a number of dynamics in the market. In the IPE market, which is increasingly genericized, more pricing pressure, more competition. We'll see how that progresses in the future, but here we are, almost 5 years since the first generic was introduced into the market. Now there are multiple generics, and we've maintained over a 40% share in the IPE category. We'll continue to execute on the US business with this strategy, which has worked well. Regarding Recordati, overall, we're in the transition phase right now. The teams are working exceptionally well together. There are a lot of moving parts. Essentially, our team has been doing a lot of work.

To launch the AG and Thats based on a number of dynamics in the market.

In the.

The IP market, which is increasingly genericize more pricing pressure more competition, we will see how that progresses in the future, but here we are almost five years since the first generic.

It was introduced into the market now there are multiple generics and we have maintained over 40% share.

Category. So we'll continue to execute on the U S business with the strategy, which has worked well.

Regarding record Audi overall were where the transition phase right now the teams are working exceptionally well together there are a lot of moving parts.

Essentially it's a.

Our team.

Yes.

Been doing a lot of work.

There is.

There's a lot of activity a lot of progress made in individual countries that we're trying to smooth smoothly and quickly pass the baton to record Audi.

Aaron Berg: There's a lot of activity, a lot of progress made in individual countries, and we're trying to smoothly and quickly pass the baton to Recordati. They're excited to pick it up. They're going to make the product a priority, and we'll have, as we stated in the script, that Recordati will have full control of commercialization by the end of the year. We'll have further clarity on in-market demand as time goes on. As you know, with launches, which some of this is in particular in Italy, it takes some time for commercialization efforts to make an impact. Once we see that impact, we'll certainly be commenting on in-market demand in Europe, and we'll certainly be providing the financial results as we have on a quarterly basis. Thank you. Hope that helped.

They're excited to pick it up they're going to make the product a priority and we will have.

As we stated in the <unk>.

In the script.

Thats a record order, we will have full control of commercialization.

By the end of the year.

We'll have further clarity on end market demand.

As time goes on as you know with with.

With launches, which some of this is particularly in Italy. It takes some time for commercialization efforts to make an impact but once we see that impact will certainly be a.

Commenting on end market demand.

In Europe, and we will certainly be providing the financial results as we have on a quarterly basis.

Thank you.

Ill.

Okay.

Thank you. Our next question is coming from Jessica Fye with Jpmorgan. Your line is life.

Operator: Thank you. Our next question is coming from Jessica Fye with J.P. Morgan. Your line is live.

Hey, guys. Good morning, Thanks for taking my questions.

Jessica Fye [Managing Director, Equity Research Analyst: Hey, guys. Good morning. Thanks for taking my questions. Curious with the rebound in script growth quarter-over-quarter, just how you're thinking about U.S. volume for the back half of the year as well as your latest expectations on the near-term trajectory for net price in the U.S. Separately, you mentioned that you're reviewing other strategic opportunities. What's on the menu there? Not committing you to anything, just what are some of the possibilities that you might entertain? Lastly, just a little help with modeling. Can you just help us think about the timeframe over which we should expect that $70 million of annualized cost savings to be realized with a little more nuance quarter-by-quarter? Thank you.

I'm curious with the.

Rebound in script growth quarter over quarter, just kind of how youre thinking about U S volumes for the back half of the year and as well as kind of your latest expectations on the near term trajectory for your net price in the U S and then separately.

You mentioned kind of you know you'd think of reviewing other strategic opportunities where part of the menu, they're not coming in anything, but just kind of like what are some of the possibilities that you might entertain and then lastly, just little help with modeling can you just help us think about kind of like the timeframe over which.

We should expect that $70 million of annualized cost savings to be realized and with a little more nuance.

You know kind of quarter by quarter. Thank you.

Sure Hi, Jeff and thanks for joining us and thanks for the questions.

Aaron Berg: Sure. Hi, Jess, thanks for joining us, and thanks for the questions. First of all, regarding the volume in the US for H2 of the year. Not only do we maintain the exclusives that we had in H1 of the year, a major payer put VASCEPA back in the exclusive position starting 1 July. I assume you're commenting on that rebound in our share and in our volume. There's the typical Q2 growth, then we had a payer add VASCEPA to the exclusive position in Q3. We expect to maintain that volume going into H2 of the year and as we stated, we'll have further clarity on 2026 as we get to the end of the year. Pete, do you want to comment on net price?

<unk>.

First of all regarding the volume in the U S. In the second half of the year.

Not only do we maintain the exclusives that we had in the first half of the year, but a major payer.

Put.

Vascepa back in the exclusive position for.

Starting July one and Thats why you saw.

I assume youre, commenting on that rebound and our share and our volume.

There is the typical Q2 growth and then we had a payer ad.

Uh huh.

And the secret to the exclusive position and in Q3, so we expect to maintain that volume.

Going into the second half of the year and as we stated we will have further clarity on 2026 as we get to the end of the year. Pete do you want comment on net price sure. Thanks, Dan. Thanks for the question as far as net price.

Peter Fishman: Sure. Thanks, Aaron. Thanks for the question. As far as net price, we would expect it to remain fairly comparable to what we've seen in Q2, as long as we don't lose any of the exclusives for the rest of the year. As Aaron had mentioned, we don't anticipate losing them, but that would be where we would see an impact on net selling price. Otherwise, the way you can look at it is relatively consistent to this past quarter. Also, I'll go through from the cost savings and the $70 million. The way we would look at it is you could really straight line that over the next four quarters.

We would expect it to remain fairly comparable to what we've seen in Q2.

As long as we don't lose any exclusives for the rest of the year.

As Darin mentioned, we don't anticipate losing them, but that would be that where we would see an impact on that some credits otherwise.

The way you can look at it is.

Relatively consistent.

Next quarter.

Also I'll go through from a cost savings in the $70 million.

The way we would look at it is you could really kind of straight line that over the next four quarters.

And that this next quarter or so as we're going through the transition period.

Peter Fishman: However, in this next quarter or so as we're going through the transition period, there might be a little bit less of that savings, but you'd see that in the restructuring bucket in terms of that cost amount. From an OpEx excluding restructuring, you'll begin to see that on a straight line basis over the next four quarters.

May not see.

On the similar there might be a little bit less of that savings.

But do you see that kind of in that the restructuring bucket in terms of that that cat.

Cost.

But from our Opex, excluding restructuring you'll begin to see that.

Kind of on a straight line basis over the next four quarters.

And then regarding the question around the strategic opportunities. So right now our primary focus is on driving vascepa globally.

Aaron Berg: Regarding the question around the strategic opportunities. Right now, our primary focus is on driving VASCEPA globally, helping all of our partners, in particular, of course, a major focus on Europe right now to help Recordati get up to speed and take command of the commercialization efforts as quickly as possible. We're looking forward to them making an impact and doing what we can to help them make an impact through the rest of the year and certainly kicking off 2026. With regard to the strategic opportunities, we're in a position of strength. We've got a solid operational and financial foundation. We've just made it much stronger as a result of this partnership and the restructuring and the resulting cost savings. Nothing is off the table in terms of those options. We'll be very judicious in looking at what those opportunities are.

All of our partners in particular of course, a major focus on Europe right now to help record order you get up to speed take command of the commercialization efforts as quickly as possible and we're looking forward to them, making an impact and doing what we tend to help them make an impact.

Through the rest of the year and certainly kicking off 2020, but with regard to the strategic opportunities. We are in a position of strength, we've got a solid operational and financial Foundation.

We've just made it much stronger as a result of this partnership and the restructuring and the resulting cost savings.

Nothing is off the table in terms of those options.

We'll be very judicious in looking at what those opportunities are they.

They could take any shape or form of course, theres no assurance or timeline.

Aaron Berg: They can take any shape or form. Of course, there's no assurance or timeline for the transaction and no assurance that a transaction will occur. Overall, we don't intend to comment further or provide updates with respect to strategic alternatives other than what's required of us. We look forward to approaching this effort with enormous confidence from a position of strength and a focus on shareholder value.

For the transaction.

No assurance that a transaction will occur and an overall, we don't intend to comment further.

<unk> update so with respect to strategic alternatives.

Other than what's required of us.

We look forward to.

Approaching this effort with enormous confidence from position of strength and our focus on shareholder value.

Great. Thank you.

Jessica Fye [Managing Director, Equity Research Analyst: Great. Thanks.

Aaron Berg: Thank you.

Thank you. Our next question is coming from Roanna Ruiz with Leerink. Your line is live.

Operator: Thank you. Our next question is coming from Roanna Ruiz with Leerink. Your line is live.

Thank you everyone. This is amazing Ali Mohammed on for Ron or <unk>.

Mazi Alimohamed: Thank you, everyone. This is Mazi Alimohamed on for Roanna Ruiz. 1, it's a 2-parter, but 1 from us. With strong IP protection in Europe and Recordati's established CV infrastructure, what are your realistic expectations for European market penetration over the next 3 to 5 years? In a second part to this is how does Recordati's presence in both primary care and specialty cardiology position VASCEPA differently than your previous direct approach? Thank you.

I wanted to to partner, but one from us so with the strong IP protection in Europe and record audience established CV infrastructure, what are your realistic expectations for European market penetration over the next three to five years and then in kind of a second partner to that says how does record <unk> presence in both primary care and specialty.

<unk> positioned <unk> differently than your previous direct approach. Thank.

Thank you.

Thanks Basie.

So.

Aaron Berg: Thanks, Mazi. First of all, as we've commented before, it's very early to be making projections on three to five years of what we expect from a forecasting perspective out of our partnership in Europe. We know we're at the early stages in a number of countries. We know that our team has done a phenomenal job with what we've had. It's been a limited effort. All hands on deck with who we've had, but we're a smaller organization, as we've commented on before. We were trying to build it from scratch. We had no existing infrastructure. We had to build that. The relationships, establish the brand, all of that we had to do. Recordati, on the other hand, is a well-established cardiovascular European organization. We're thrilled to see their passion and how quickly they want to take command and be driving growth.

First of all as we as we've commented before it's very early to be making projections.

On three to five years of what we expect.

From a forecasting perspective.

<unk>.

Our partnership in Europe, We know we're at the early stages and a number of countries.

We know that our team has done a phenomenal job with what we've had.

Been a limited.

Kurt.

All hands on deck, with whom we've had but.

We're a smaller organization as we've commented on before we were trying to build it from scratch, we had no existing infrastructure we.

We had to build that the relationships established the brands all of that we had to do record audio on the other hand is a well established cardiovascular European organization.

And we're thrilled to see their passion and how quickly they want to take command and be driving growth. So we're very optimistic about the ability to grow and the ability to accelerate the growth.

Aaron Berg: We're very optimistic about the ability to grow and the ability to accelerate the growth. Part of that is part two of your question, and that is, our efforts have been very focused on the highest-risk patients and focused on specialists. We've been operating more as a specialty organization in Europe, very limited in terms of our infrastructure, in terms of our spend, in terms of our reach to providers. Recordati, they see the opportunity and because of the label and the reimbursement we have, which is broad, they have the opportunity to go to the physicians that treat these patients, which include primary care as well. Given that they have an already established primary care organization on top of a cardiology center organization, that will make this certainly much better, make the impact, we think, much greater than we would've been able to do.

Around part of that is part two of your question and that is our efforts have been very focused on the highest risk patients had focused on specialists.

You've been more operating more as a specialty organization of Europe very limited in terms of our infrastructure in terms of our spend in terms of our reach to providers.

Record Audi they see the opportunity because of the label and the reimbursement we have which is broad.

Or have the opportunity to go to the physicians that treat these patients which include primary care as well given that they have already established primary care organization on top of a cardiac cardiology centric organization that will make this a certainly much better.

Make the impact we think much greater than we would've been able to do so we look forward to that growth.

When it's when the time is right once they make an impact as we said earlier, we'll be reporting on what those results are.

Aaron Berg: We look forward to that growth and when the time is right, once they make an impact, as we said earlier, we'll be reporting on what those results are. Thank you.

Okay, great. Thank you so much.

Mazi Alimohamed: Great. Thank you so much.

Thank you.

As we have no further questions on the lines at this time I would like to hand, the call back over to Mr. Berg for any closing remarks.

Operator: Thank you. As we have no further questions on the lines at this time, I would like to hand the call back over to Mr. Berg for any closing remarks.

Yes. Thank you very much I appreciate it.

First of all we hope everyone found the update helpful. We appreciate you taking the time out of your busy days to join us today and enjoy the rest of the day. Thank you.

Aaron Berg: Yeah. Thank you very much. Appreciate it. First of all, we hope everyone found the update helpful. We appreciate you taking the time out of your busy days to join us today, and enjoy the rest of the day. Thank you.

Okay.

Thank you ladies and gentlemen, this does conclude today's call you may disconnect. Your lines at this time and we thank you for your participation.

Operator: Thank you, ladies and gentlemen. This does conclude today's call. You may disconnect your lines at this time, and we thank you for your participation.