Amarin Corp Plc 2026 Q3 Earnings Call

Sir, you may begin. Thank you for your time and attention this morning as we discuss Amarin's 2026 third quarter financial results.

On today's call are Aaron Berg, President and Chief Executive Officer, Pete Fishman, Chief Financial Officer, and Steve Ketchum, President of Research and Development and Chief Scientific Officer. Other members of the senior management team will be available as needed during the Q&A session following the prepared remarks. Aaron will provide a state of the company update. Pete will discuss the numbers, and Steve will review recent medical and regulatory activities. Before we begin, I'd like to remind everyone that today's press release and related quarterly report on Form 10-Q will be available on the Investor Relations section of the company's website, www.amarincorp.com, as well as a replay of this call shortly after its completion.

Please be aware that during this call, we may make certain statements related to our business that are deemed forward-looking statements under federal securities laws. Statements are not guarantees of future performance, but rather are subject to a variety of risks and uncertainties. Our actual results could differ materially from expectations reflected in any forward-looking statements. Additionally, we assume no obligation to update these statements as circumstances change. For a discussion of the material risks and important factors that could affect our actual results, please refer to our SEC filings, which are available either on our company website or the Securities and Exchange Commission's EDGAR system. With that said, I'd now like to turn the call over to Amarin's President and CEO, Aaron Berg.

Aaron, please go ahead. Thanks, Devin, and thank you all for joining us today.

As we approach the end of the year, I want to take the opportunity to highlight all that we've achieved, what lies ahead, and most importantly, how we continue to hold ourselves accountable to the standard of delivering value to our shareholders. As you can see in our press release, through the hard work of our team, the support of our commercial partners, and the enduring clinically validated efficacy of VASCEPA, the momentum we experienced in the first half of 2026 continued through the third quarter across multiple fronts, including profitable third-quarter results, reductions in our expense profile, continued positive operating cash flow, a stronger cash position, and zero debt. Our outlook for the full year remains positive. Our partners are expanding the global reach of VASCEPA and VAZKEPA and driving double-digit in-market demand growth.

We've also maintained our U.S. leadership position in a highly competitive IPE space. We also announced exciting news earlier this week regarding clinical trial results, which may further add to our continued work on broadening our understanding of VASCEPA's potential beyond cardiovascular care, and we'll touch on that shortly. As of September 30, 2026, through our exclusive agreement with Recordati, VAZKEPA was commercialized in 11 countries in Europe. In October, VAZKEPA launched in Poland on a private pay basis. In-market demand in Europe for VAZKEPA under the Recordati partnership rose by an estimated 68% in Q3 2026 compared to the same period last year. Spain, U.K., and Italy continue to produce strong results, which are helping to build a foundation for future growth as pricing, reimbursement, and commercialization efforts continue across the broader territory. Recordati has been an outstanding partner.

While we're still in the early stages of the partnership, their execution and investment are driving momentum materially above historical European growth rates achieved by Amarin prior to the licensing transaction. With the rights to commercialize VAZKEPA across 59 countries, a deep heritage in cardiovascular disease, and extensive commercial capabilities throughout Europe, Recordati is unlocking opportunities beyond our reach in a region with substantial untapped potential. Combined with intellectual property protection through 2039, we have a long runway to create value together. Across our combined global partner network, in-market demand for VASCEPA rose by an estimated 55% in Q3 compared to the same period last year, reflecting continued in-market demand growth. We're continuing to support our local partners in preparation for launches in Singapore and South Korea in early 2027, and with additional regulatory approvals and market launches across Southeast Asia.

We maintained our leading position in the U.S. IPE market with a 47% share while continuing to manage the business profitably. Pricing remains competitive, but our commercial discipline, focus, and efficiency continue to support our position. We continue to expect to maintain our exclusivity with key payers through the end of 2026 and expect U.S. volumes to remain stable through year-end. As background, changes in product exclusivity are part of the normal cadence of our U.S. commercial business. At the same time, our strengthened operating infrastructure gives us greater flexibility to be selective as we evaluate opportunities and elect to move forward only when the economics make sense and support our profitability objectives. I'll now turn the call over to Pete Fishman, our Chief Financial Officer, who'll go over our results.

Pete? Thanks, Aaron. We reported our first profitable quarter in two years, reflecting the benefits of our completed restructuring as well as our company-managed U.S. and fully partnered international commercial model.

Our third quarter performance demonstrated continued progress against our core priorities: supporting international in-market growth for our partners, maintaining our leadership position in the U.S. IPE market, establishing a significantly lower go-forward cost base, and strengthening our overall financial position. Total net revenue in the third quarter of 2026 was $39.6 million, compared to $49.7 million in the third quarter of 2025. This consisted of total product revenue of $36.9 million, compared to $48.6 million, and licensing and royalty revenue of $2.7 million, up from $1.1 million. U.S. product revenue was $28.5 million, compared to $40.9 million in last year's third quarter. The decrease reflected lower net selling prices associated with changes in customer mix, driven largely by generic competition.

While pricing remains competitive, continued volume strength, combined with operating efficiencies, supported the U.S. business's ongoing profitability and cash generation. In Europe, third quarter product revenue declined to $3.7 million from $4.1 million under our partner model. Rest of World product revenue rose to $4.7 million from $3.6 million in the prior year period, reflecting continued commercial investment and execution by our partnership network. In-market demand across Europe rose by an estimated 68% from last year's third quarter, with Rest of World in-market demand rising an estimated 46%. I'd like to briefly address the relationship between our international product revenue and in-market demand. We are encouraged by the in-market demand growth of VASCEPA VAZKEPA across Europe and the rest of the world.

In-market demand provides a more direct view of the underlying growth of our international business, and we expect this growth to contribute to increased partner supply purchases and related revenue over time as our partnered international commercial model matures. The timing and level of these purchases will continue to reflect partner inventory levels and ordering patterns and may not grow at the same rate as in-market demand in any given period. Because partner purchases can vary quarter to quarter, we believe a trailing 12-month view provides helpful context alongside quarterly comparisons. On that basis, international in-market demand increased an estimated 59% compared with the preceding 12-month period, reflecting sustained growth beyond any single quarter. Over time, we expect international product revenue to be best evaluated on this same basis. Cost of goods sold in the third quarter declined to $23.4 million from $27.5 million in the prior year period.

We use the weighted average cost of our inventory to calculate cost of goods sold, which is influenced by API purchases, U.S. sales volumes, and the size and timing of supply shipments to our international partners. Our Q3 results reflect the early benefits of our renegotiated supply contracts, which contributed to a sequential gross margin improvement, excluding write-offs, of approximately 2.3 percentage points, despite continued U.S. pricing pressure. While we expect our cost per unit to decline over time, the benefit will flow through gradually, and gross margin may vary from quarter to quarter based on sales mix and the timing and volume of partner shipments. Inventory management remains a high priority, and our reduced inventory levels reflect our commitment to disciplined working capital management that aligns supply levels with demand.