Amarin Corporation plc

Good morning, and welcome to Ameren Corporation's conference call to discuss its second quarter 2025 financial results. I would now like to turn the conference over to Mr. Mark Marmar, Vice President, Corporate Communications and Investor Relations at Ameren. Sir, the floor is yours.

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 State Arbor 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 murders, 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, 2024, and the quarterly report on Form 10-Q for the quarter ended June 30, 2025. which have been filed with the SEC and are available through the investor relations section of our website at www.amarinforge.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 Pete Fishman, Ameren's Chief Financial Officer will review our second quarter of 2025 financial results. Following these prepared comments, there will be a question and answer session. With that, I will turn the call over to Aaron Berg, President and Chief Executive Officer of Ameren. Aaron?

Thank you, Mark. Good morning, everyone, and thank you for joining us today. Q2 2025 was a pivotal quarter for Ameren, 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 Vescapa across Europe. Partnering with Recordati will build on our early efforts to drive the commercialization of Vescapa 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. We expect that, through this partnership, the SCEPA 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 operating expense 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, and we've consistently done over recent years. These significant steps better position us to maximize the global potential for Vesipa and drive increased shareholder value powered by the following key foundational strengths. Number one, the SEPA 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 icospin 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 Vesepa 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 reduced 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. 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 and our second quarter 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 the SEPA worldwide. While the U.S. remains foundational to our business, I'd like to focus on the progress we're seeing across Europe and in our rest of the world markets, where, through our partnerships, we continue to expand access to VSIPA 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 VSIPA 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. 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. 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 VSCEPA 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. Both teams are working exceptionally well together, and we're impressed with how passionate and knowledgeable the Recordati team is about Veskepa and its benefits for patients. Now turning to the rest of the world markets, our partners are focused on driving patient uptake through the tremendous value and potential for Visipa in their respective markets and continue to make progress in commercialization or regulatory process locally. In China, our partner, Edding Farm, 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 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 CBD mortality rates globally, China continues to represent a significant long-term opportunity for Amarin. In Australia, our partner CSL Securus 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 the first quarter of 2025 versus the fourth quarter of 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 July 1, 2025. We expect this will expand public reimbursement and access to the SEPA 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, an established company with significant in-region capabilities, is advancing regulatory and pricing reimbursement processes across Southeast Asia. Recently, South Korea granted regulatory approval for Basipa, taking us to 50 markets globally where Vesepa 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 the world is critical to our global strategy of making Vesepa 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 the SEPA. Lastly, a few comments about the U.S. business, still the core contributor of revenue for the company. We've sustained the SEPA franchise for more than four years after the introduction of the first generic product in the U.S. Thanks to the dedication of our team We retained all major exclusive accounts through Q2 2025, and our market share remained 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, when optimal, as part of our ongoing product lifecycle management approach. In summary, our US business remains a significant cash generator, almost five years post generic entry. The European business and rest of world partnerships continue 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 global potential. To conclude, let me end with the following. Ameren 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 addition, 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 Ameren 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 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, 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 Vesipa 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. Pete.