アマリン（AMRN）2026年第3四半期決算説明会：海外需要の拡大に伴い収益性が回復

主要なポイント

• アマリン・コーポレーション（NASDAQ: AMRN）が発表した2026年第3四半期の純売上高は3,960万ドルとなり、ブランド薬「VASCEPA」の全米での販売数量は安定していたものの、米国における価格下落圧力が響き、前年同期の4,970万ドルから減少しました。
• 同社の純利益は24万5,000ドル（1株当たり0.01ドル未満）となり、前年同期の770万ドルの純損失（1株当たり0.02ドルの赤字）から黒字転換しました。同社にとって四半期ベースでの黒字化は2年ぶりとなります。
• 第3四半期の営業キャッシュフローは900万ドルのプラスとなりました。2026年9月30日時点の現金および有価証券は3億2,400万ドルと、2025年年末から2,100万ドル増加し、無借金経営を維持しています。
• 海外事業の成長モメンタムが強化され、欧州における「VAZKEPA」の推定需要は前年同期比で68%増加したほか、グローバルパートナーによる「VASCEPA」の合計需要は55%増加しました。
• 医師主導の第III相EMT2試験では、主要評価項目である無悪化生存期間（PFS）が達成されませんでした。しかし、主要な副次評価項目である全生存期間（OS）においては、「VASCEPA」投与により死亡ハザードが統計学的に有意な32%低減しました。
• 経営陣は、2026年通期の営業キャッシュフローの黒字維持および年末までの米国販売数量の安定を見込む一方、米国での価格下落圧力は2027年にかけて継続すると予想しています。

主要財務データ

事業および業績の動向

「VASCEPA」は米国のイコサペント酸エチル市場で47%のシェアを維持しました。経営陣によると、ブランド処方薬の販売数量はほぼ横ばいだったものの、純販売価格の下落が前年同期比での減収要因となりました。同社は、2026年末まで米国の主要支払機関との独占契約を維持できると見込んでいます。

欧州では、2026年9月30日時点でレコルダティ社（Recordati）を通じて11カ国で「VAZKEPA」の商業展開が行われました。10月にはポーランドで自費診療向けの販売を開始しました。スペイン、英国、イタリアが引き続き最大の寄与国となっており、レコルダティ社は対象とする59カ国で価格設定、償還手続き、商業化の取り組みを継続しています。

第3四半期における欧州の推定市場需要は前年同期比で68%増加し、その他地域（ROW）の需要も46%増加しました。海外事業全体では、直近12ヶ月間の最終市場需要が前12ヶ月間と比較して推定59%増加しました。

アマリンは、パートナーによる製品調達量が在庫水準や発注スケジュールの関係で、単一の四半期においては最終市場需要の動きと必ずしも一致しない可能性があると注意を促しています。2027年年初にはシンガポールおよび韓国での販売開始に向けた準備が進められているほか、東南アジア全域で規制対応や商業化活動が展開されています。

供給契約の再交渉により、評価損を除いた売上総利益率は前期比で約2.3ポイント改善しました。在庫は2024年第4四半期以降31%減少し、事業に固定されていた運転資金が圧縮されました。

臨床および規制の動向

EMT2試験には、大腸がん肝転移に対する肝切除術を受ける患者448名が登録されました。患者は標準治療とともに、手術前および手術後最大4年間にわたり「VASCEPA」またはプラセボの投与を受けました。

同試験は主要評価項目である無悪化生存期間（PFS）を達成できなかったものの、主要な副次評価項目である全生存期間（OS）において、死亡ハザードを統計学的に有意な32%低減させました。経営陣は、アマリンが今後の開発経路や商業的機会を特定する前に、今回の知見は研究段階のものであり、リーズ大学の研究グループとさらなる解析を行う必要があると強調しました。

これとは別に、欧州透析移植学会（European Renal Association）とともに策定された、心血管疾患および慢性腎臓病の管理に関する最新の欧州ガイドラインにイコサペント酸エチルが記載されました。

経営陣による業績予想（ガイダンス）

経営陣は、2026年通期で営業キャッシュフローの黒字を見込む方針を維持しています。米国の販売数量は年末まで安定して推移すると予想されるほか、2026年末まで支払機関との独占契約が継続するため、価格設定も比較的安定的に推移する見通しです。

同社は2027年のガイダンスを発表していません。支払機関との独占契約の確認を待っている段階であり、過年度に見られた米国での価格下落圧力は2027年まで続くと予想しています。

アマリンはまた、専任の財務アドバイザーであるバークレイズとともに、株主価値の最大化を目指す取り組みを進めています。経営陣は、協議の結果が自社株買いの可能性を含め、潜在的な資本配分の時期、規模、優先順位に影響を与えると述べています。

リスクおよび注目点

• ブランド薬の販売数量は安定しているものの、後発医薬品との競合が米国での純販売価格を圧迫し続けています。
• 2026年以降の米国支払機関との独占契約には不透明感が残っており、経営陣は価格圧力が2027年まで続くと予想しています。
• 海外での製品売上高は、パートナーによる購入量が在庫水準、販売構成比、発注タイミングに依存するため変動する可能性があります。
• 粗利益率は、米国での価格設定、製品ミックス、海外出荷のタイミングや規模に応じて四半期ごとに変動する場合があります。
• EMT2試験は主要評価項目を達成できず、「VASCEPA」の腫瘍学領域への広範な適用には、追加の解析、科学的検証、さらには商業的および知的財産上の評価が必要となります。

アナリスト質疑応答のハイライト

米国の処方数と売上高の乖離について問われた経営陣は、ブランド薬「VASCEPA」の販売数量は安定しており、売上減少は価格下落圧力によるものだと説明しました。

欧州での保険償還に関して、経営陣はレコルダティ社による59カ国に及ぶ広範なカバー範囲、直近のポーランドでの発売、フランスでの進行中の活動を強調しました。なお、追加の償還決定に関するスケジュールは示されませんでした。

新たな治療への応用に関して、経営陣は未充足の医療ニーズ、既存のエビデンス、商業的可能性、知的財産の保護、開発リスクを評価すると述べました。アマリンは、EMT2試験から生じる追加開発の資金調達を支援するパートナーを求めるかどうかについて、現時点では決定していません。

決算説明会トランスクリプト全文

決算説明会の完全なトランスクリプト

経営陣による説明

Operator

Greetings, and welcome to the Amarin Corporation's Third Quarter 2026 Results Conference Call. [Operator Instructions] And please note, this conference is being recorded.

I will now turn the conference over to your host, Mr. Devin Sullivan, Investor Relations. Sir, you may begin.

Unknown Executive

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.

Aaron Berg

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 0 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. And 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 will go over our results. Pete?

Peter Fishman

Thanks, Aaron. We reported our first profitable quarter in 2 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 end 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' 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. End-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 end market demand.

We are encouraged by the in-market demand growth of VASCEPA VASKEPA 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 end 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 the 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. For perspective, inventory has declined by 31% from Q4 2024, underscoring our progress in optimizing inventory and reducing the capital tied up in the business, contributing to our improved operating cash flow. Total operating expense declined by 44% from last year's third quarter, driven largely by a 27% decline in SG&A and no restructuring expenses during the quarter compared to $9.4 million last year, while R&D remained stable.

Excluding restructuring costs, total operating expenses declined by 22%, reflecting the lower go-forward cost structure established through our restructuring, which we intend to maintain through continued spending discipline. Net income for the quarter was $245,000 or less than $0.01 per share compared to a net loss of $7.7 million or $0.02 per share in last year's third quarter. We generated positive operating cash flow for the third quarter of $9 million. Through the first 9 months of 2026, operating cash flow totaled $22 million compared to a cash outflow of $9 million during the prior year period. We continue to expect positive operating cash flow for the full year. We ended September with cash and investments of $324 million, an increase of $21 million from year-end 2025 and remain debt-free.

That said, I'll turn things back to Aaron.

Aaron Berg

Thanks, Pete. As our global footprint continues to expand, the work of our medical affairs, regulatory and R&D teams becomes increasingly important. Their efforts have resulted in a total of 28 publications, inclusive of abstracts, posters and articles this year-to-date. Beyond that, these teams provide expertise that supports our commercialization partners worldwide from navigating local regulatory requirements and expanding the evidence base for icOSpineyl to engaging scientific leaders, supporting reimbursement discussions and preparing for successful launches.

Before turning things over to Steve Ketchum, Amarin's Chief Scientific Officer, I want to provide some background on an exciting recent development related to the exploratory use of VASCEPA as an adjunct to standard of care in treating a defined population of colorectal cancer patients. The top line results from the investigator-initiated EPA for metastasis Trial 2 or EMT2 Phase III trial using VASCEPA were presented at this year's European Society for Medical Oncology in Madrid, Spain this past weekend.

Importantly, the investigational medicinal product used in EMT2 was VASCEPA in the same dosage utilized in the landmark REDUCE-IT cardiovascular outcomes trial that produced a 25% relative risk reduction in major adverse cardiovascular events. While these results provide a foundation for exploring the potential role for cospenethyl in cancer care, our focus now is on working with our team to better understand the opportunity and its potential to benefit patients. To provide additional perspective on this trial and more broadly, scientific, medical and regulatory activities supporting our global growth strategy,

I'll now turn the call over to Steve Ketchum. Steve?

Steven Ketchum

Thank you, Aaron. This quarter was marked by several important scientific and medical affairs accomplishments that continue to reinforce the value of Vascepa while expanding our understanding of the broader biology of highly purified EPA. We maintained a strong presence at the European Society of Cardiology Congress, where 5 investigator-led presentations further strengthened the growing body of evidence supporting icosapapentpeethyl.

These presentations included new analyses from REDUCE-IT, mechanistic research exploring the effects of EPA across multiple cardiovascular risk pathways and data evaluating long-term outcomes, treatment adherence, lipoprotein A, coagulation biomarkers and other biological mechanisms that may contribute to the benefits observed with IPE. Importantly, ESC also featured the inclusion of icosapent ethyl within the newly issued guidelines for the management of cardiovascular disease and chronic kidney disease in collaboration with the European Renal Association, reinforcing the role of icosapent ethyl as an evidence-based treatment option for appropriate high-risk patients and underscoring its continued relevance in contemporary cardiovascular care.

Beyond our own data, and as Aaron mentioned, investigators from the University of Leeds and other institutions in the U.K. presented results from the EPA for metastasis Trial 2, or EMT2, this past weekend at the ESMO Congress in Madrid. EMT2 was a randomized, double-blind, placebo-controlled investigator-initiated Phase III study evaluating Vascepa, a highly purified ethyl ester form of EPA as an adjunct to standard of care treatment in patients undergoing liver resection for colorectal cancer liver metastases. The study was sponsored by the University of Leeds and enrolled 448 patients who were randomized to receive either Vascepa or placebo beginning prior to liver surgery and continuing for up to 4 years after liver surgery.

The prespecified and statistically powered key study endpoints were progression-free survival and overall survival. Importantly, while the primary endpoint of progression-free survival was not met, the study demonstrated an improvement in the key secondary endpoint of overall survival. a statistically significant 32% lower hazard of death, which is a meaningful finding in a patient population where up to 60% of patients may experience disease recurrence within 2 years following surgery. These findings represent an important contribution to the scientific understanding of IPE and warrant continued evaluation and discussion by the research community.

Notably, EMT2 utilized the same VASCEPA clinical formulation and dose of icosapent ethyl or IPE used in REDUCE-IT. While cardiovascular disease remains our approved indication and our primary focus, findings from EMT2 add to a growing body of evidence suggesting that IPE may exert broad biological effects across multiple pathways and disease processes. Over the past several years, research has increasingly suggested that EPA may influence mechanisms associated with inflammation, oxidative stress, thrombosis, cellular signaling and vascular biology.

Publications related to omega-3 fatty acid used for colorectal cancer prevention, treatment and/or mechanisms of action have reported several biologically plausible hypotheses, including incorporation of EPA in colonic or colorectal tissue, direct anti-inflammatory or antineoplastic activity of prescription IPE and potential augmentation of host antitumor immune surveillance through effects on the gut microbiome. These potential mechanisms remain investigational and require further analysis from EMT2 and from new research.

Of note, recently, an investigator-initiated mechanistic study from the Massachusetts General Hospital in Boston, Massachusetts as well as other institutions published in the American Journal of Clinical Nutrition in June 2026, found that treatment with Vascepa cosapinephyl substantially increased incorporation of marine omega-3 fatty acids, particularly EPA into colorectal tissue. While much remains to be understood, findings from studies such as REDUCE-IT, the growing body of mechanistic research, IIT research and now EMT2 continue to reinforce the unique and increasingly differentiated profile of highly purified IPE, supporting continued scientific investigation into the broader biological effects of prescription IPE and its potential role in areas of significant unmet medical need.

Looking ahead, we remain committed to advancing the science of IPE through collaboration with leading academic investigators around the world. We have just seen the EMT2 results, and we will continue to collaborate with Professor Ho and the University of Leeds Research Group to further evaluate the data and a path forward for Amarin. We are also excited about the upcoming 2026 American Heart Association Scientific Sessions. -- where investigators will present new data related to lipoprotein A, an area of increasing interest within cardiovascular medicine. More than a decade after REDUCE-IT was initiated, investigators continue to generate new insights into the effects of highly purified IPE.

While many questions remain, the breadth and consistency of the data continue to strengthen our understanding of IicOSapentthyl and its potential impact on human health. With that overview of our scientific progress,

I'll now turn the call back to Aaron.

Aaron Berg

Thanks, Steve. Our third quarter results demonstrate that the transformation of our business is translating into tangible operational and financial benefits. We have expanded our global footprint and look forward to a greater global presence in 2027. With a significantly lower cost base, improving supply economics and disciplined working capital management, we've generated 4 consecutive quarters of positive operating cash flow and strengthened our debt-free balance sheet.

While U.S. pricing pressure and the timing of partner orders continue to influence revenue, growing international in-market demand reinforces the opportunity ahead and the added potential opportunity for VASCEPA reflected in the EMT2 trial results only adds to our optimism. We entered the final quarter of 2026 from a position of strength, focused on sustaining positive cash generation, supporting our partners' growth and building long-term shareholder value. In parallel, the progress we've made in reshaping Amarin has put us in a stronger position than at any point in our recent history to deliver value to our shareholders.

Building on that and guided by a clear mandate to maximize shareholder value, we continue to work closely with Barclays, our exclusive financial adviser and remain focused on working through these efforts in a timely and disciplined manner. These discussions and their potential outcomes will inform the timing, scale and prioritization of future capital deployment activities such as a share repurchase.

And with that, operator, let's open the call to questions from our analysts.

Operator

[Operator Instructions] Our first question today is coming from Jessica Fye with JPMorgan.

質疑応答

Jessica Fye

I didn't catch the branded prescription growth that usually comes in the press release this quarter. Can you comment on that? How do we reconcile U.S. script volume growth with the decline in U.S. revenues year-over-year?

Unknown Executive

Jess, thanks for joining us. I appreciate the question. The volume for the branded Vascepa was stable. It was relatively flat. The downward impact on revenue was due to pricing pressure.

Jessica Fye

Okay. And then can you just give us a little bit of a sense about how to think about the U.S. price trajectory over the coming kind of quarters?

Unknown Executive

Yes, I'll turn it over to Pete to address that.

Peter Fishman

Yes. When we look at the U.S. pricing over the rest of this year, as we've talked about, we do expect to maintain our exclusives. So we expect the pricing to remain relatively consistent through the end of this year. While we haven't given guidance on '27, and we are still waiting for final confirmation on how the exclusives will look like going into 2027. We have seen that continued pricing pressure over previous years and would anticipate that to continue into '27.

Operator

Our next question is coming from Paul Choi with Goldman Sachs.

Kyuwon Choi

I wanted to ask on where you're able to comment on any updates in terms of reimbursement and coverage in major European markets. Any additional color there would be helpful. And my second question is in terms of thinking about the additional therapeutic applications for IPE, sort of what criteria are you considering here? And are you looking for a partner to help co-fund future development?

Aaron Berg

Paul, thanks for joining us. Thanks for the questions. Regarding reimbursement in Europe, we've been very encouraged by the approach that Recordati take. As we mentioned, the partnership is for 59 countries. They -- not just focusing on the major markets in Western Europe, but much broader than we at Amarin could have ever executed on our own. So they're making progress beyond where we've already commercialized.

In fact, as we mentioned, they just launched in Poland. It's public that there's activity going on with France, a very lengthy process. We're certainly optimistic and we believe we have the right partner that certainly can advance VAZKEPA well beyond the markets where we're already commercialized. So there's a lot of activity going on. There's a lot going on to explore the potential in certain markets while at the same time, trying to find a way to enter those markets.

As we get more clarity that we can speak to, we'll certainly do that. But we're very pleased and again, in particular, that they are going well beyond where we would have gone as Aron on our own. Regarding the potential other clinical applications. EMT2 certainly brings that question to the forefront. Regarding that, we just saw the data ourselves. We're very excited about that data as should patients because the second most prevalent cause of cancer death, colorectal cancer globally.

So the unmet need is there, and these are very, very sick patients that were studied. We have a lot to learn about the data, and that's what Steve has mentioned is that we'll be working with Dr. Hall as well as the University of Leeds. We'll continue collaborating with them to see where we go at the same time, from a commercial perspective, assessing what value there is for us. And that's the approach we'll take with any other potential therapeutic application.

And that is what's the commercial opportunity, what's the unmet need, what data already exists, what can we do to protect it? A lot of questions that we ask. We're fortunate that we have a molecule that has such broad application, and there's probably more we don't know still about what this drug can do that we do know. And certainly, EMT2 is a testament to that. So once we identify more about which path we go, we'll also identify whether we share in that, how we approach it.

Certainly, we will be very disciplined managing the risk and the opportunity at the same time. But once we know more, we'll certainly report on that. That's a good question. Thank you.

Operator

Apologies if you cannot hear me. Can you hear me?

Aaron Berg

Now we can.

Operator

Ladies and gentlemen, as we have no further questions in the queue at this time, I would like to turn the call back over to Mr. Berg for any closing remarks.

Unknown Executive

Yes. Once again, thank you all very much for joining us. Thanks for your attention to Amarin, and we look forward to keeping you apprised of our progress as we move forward. Thank you. Have a good day.

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.