Amarin Corporation PLC (AMRN) 2024 Q3 法說會逐字稿

Welcome to Amarin Corporation's conference call to discuss its third quarter 2024 business update and financial results. I would like to turn the conference call over to Mark Marmur, Vice President, Corporate Communications and Investor Relations at Amarin.

歡迎參加 Amarin Corporation 的電話會議，討論其 2024 年第三季的業務更新和財務業績。我想將電話會議轉給 Amarin 公司企業傳播和投資者關係副總裁 Mark Marmur。

Good afternoon, everyone, and thank you for joining us. Turning to slide 2 and our forward-looking statements. 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.

大家下午好，感謝大家的參與。轉到投影片 2 和我們的前瞻性陳述。請注意，本次電話會議將包含前瞻性陳述，這些陳述受聯邦證券法規定的安全港條款的保護。我們可能無法實現我們的目標、執行我們的計劃或意圖，或滿足我們前瞻性聲明中所揭露的預期。實際結果或事件可能存在重大差異，因此您不應過度依賴這些陳述。

We assume no obligation to update these statements as circumstances change. Our forward-looking statements do not reflect the potential impact of significant transactions we may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreements that we may enter into, amend or terminate. For additional information concerning the risk factors that could cause actual results to differ materially, please see the Risk Factors section of our annual report on Form 10-K for the year ended December 31, 2023, and our quarterly report on Form 10-Q for the quarter ended September 30, 2024, which has been filed with the SEC and is 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.

我們不承擔隨著情況變化而更新這些聲明的義務。我們的前瞻性聲明並未反映我們可能達成的重大交易的潛在影響，例如合併、收購、處置、合資或任何我們可能達成、修改或終止的重大協議。有關可能導致實際結果大不相同的風險因素的更多信息，請參閱我們截至 2023 年 12 月 31 日的年度報告（表 10-K）中的“風險因素”部分，以及我們截至 2024 年 9 月 30 日的季度報告（表 10-Q），該報告已提交給美國證券交易委員會 (SECin.S.我們鼓勵每個人都閱讀這些文件。本次電話會議的存檔將發佈在 Amarin 網站的「投資者關係」部分。

Turning to Slide 3 in today's agenda. Aaron Berg, Amarin's President and Chief Executive Officer, will provide an update on the state of the Amarin business; Pete Fishman, Amarin's Vice president and Global Controller and currently overseeing all finance-related matters for the business, will review our third quarter 2024 financial results. At the end of the presentation, there will be the chance to ask questions.

翻到今天議程的第 3 張投影片。Amarin 總裁兼執行長 Aaron Berg 將介紹 Amarin 業務的最新狀況； Amarin 副總裁兼全球財務總監 Pete Fishman 目前負責監督公司所有財務相關事宜，他將審查我們 2024 年第三季的財務表現。演示結束後，將有機會提問。

I will now turn the call over to Aaron Berg, President and Chief Executive Officer of Amarin. Aaron?

現在我將電話轉給 Amarin 總裁兼執行長 Aaron Berg。阿倫？

Thanks, Mark. Good afternoon, everyone, and thanks for joining us today. In my first full quarter as the President and CEO, I spent time with our teams both in the US and Europe as well as valuable time with many of our partners and scientific experts from around the world. My aim has been straightforward, to determine our path forward and execute the best strategies to drive access to and use of VASCEPA/VAZKEPA for the millions of at-risk patients across the globe.

謝謝，馬克。大家下午好，感謝大家今天的參與。在擔任總裁兼執行長的第一個完整季度裡，我與我們在美國和歐洲的團隊一起度過了一段寶貴的時光，同時也與來自世界各地的許多合作夥伴和科學專家共度了美好時光。我的目標很簡單，即確定我們前進的道路並執行最佳策略，以推動全球數百萬高風險患者獲得和使用 VASCEPA/VAZKEPA。

What I've known for years from the U.S. experience with VASCEPA was confirmed by those stakeholders I've heard from in Europe and around the world. VAZKEPA has the potential for significant growth, value and impact globally that remains substantially untapped. These dynamics create a tremendous opportunity, one that directly addresses cardiovascular risk worldwide and it's our obligation to patients, providers and payers as well as to shareholders to accelerate access to and use of this tremendous product. While our team has been working very hard and has made progress, this progress has not been enough.

我從美國 VASCEPA 多年經驗中了解到的情況也得到了歐洲和世界各地利益相關者的證實。VAZKEPA 在全球範圍內具有顯著的成長、價值和影響的潛力，但目前仍有很大一部分尚未開發。這些動態創造了一個巨大的機遇，可以直接解決全球心血管風險，我們有義務讓患者、供應商、付款人以及股東加速獲得和使用這一巨大的產品。雖然我們的團隊一直非常努力並且取得了進展，但這種進展還不夠。

We're still in the early stages of launch in many regions around the world with a long runway and there remains much more to do to maximize the value we know is inherent in the global VASCEPA and VAZKEPA franchise. This is based on the need, the science and the impact this product can bring for patients. Let me start with the most critical component of all, the global unmet need to reduce cardiovascular disease.

我們仍處於在全球許多地區推出產品的早期階段，還有很長的路要走，還有很多工作要做，以最大限度地發揮我們所知道的全球 VASCEPA 和 VAZKEPA 特許經營權所固有的價值。這是基於需求、科學以及該產品能為患者帶來的影響。讓我先從最關鍵的部分開始，即全球尚未滿足的減少心血管疾病的需求。

Despite more than four decades of progress in cardiovascular medicine, cardiovascular disease remains the number-one killer globally. In 2021, roughly 20 million deaths were estimated for cardiovascular disease globally, which amounted to an increase of almost 22% from the prior decade.

儘管心血管醫學已取得四十多年的進步，但心血管疾病仍是全球第一大殺手。2021 年，全球因心血管疾病死亡人數估計約 2,000 萬人，比前十年增加了近 22%。

It's astonishing that with even all the therapeutic innovation and progress we've made, this disease remains such a burden for patients, families, health care professionals and systems globally. As a result, the reduction of cardiovascular events remains a top priority for health care providers, patients, caretakers and payers, public and private.

令人驚訝的是，儘管我們在治療方面取得了許多創新和進展，但這種疾病仍然對全球患者、家庭、醫療保健專業人員和系統造成沉重的負擔。因此，減少心血管事件仍然是公共和私人醫療保健提供者、患者、照顧者和付款人的首要任務。

While LDL cholesterol is the primary target of lipid therapy, reduction of LDL isn't enough. More can and should be done to help patients reduce the risk of cardiovascular events through expanded access to existing and future treatment options that have been proven to reduce that risk, namely products like VASCEPA and VAZKEPA. Just in Europe alone, there are more than 6 million at-risk patients who are eligible for VAZKEPA based on the approved label.

雖然 LDL 膽固醇是脂質治療的主要目標，但降低 LDL 還不夠。我們可以而且應該採取更多措施，透過擴大現有和未來已被證明可以降低心血管事件風險的治療方案的覆蓋範圍，即 VASCEPA 和 VAZKEPA 等產品，來幫助患者降低心血管事件的風險。光是在歐洲，根據核准的標籤，就有超過 600 萬名高風險患者有資格使用 VAZKEPA。

And this does not include the millions of patients in Europe and around the world treated with triglyceride-lowering fibrates and omega-3 mixture products for patients being improperly used these drugs to treat cardiovascular risk. Even though these products may impact biomarkers, the large, well-controlled cardiovascular outcome trials with tens of thousands of patients have failed to demonstrate a reduction in cardiovascular events. Changing lipid biomarkers is no longer enough and can create a false sense of security for providers and patients alike. Many of these patients need to be on a treatment proven to reduce cardiovascular events. Doing more for many of these patients should include the use of VAZKEPA.

而這還不包括歐洲及世界各地數百萬接受降低三酸甘油酯的貝特類藥物和ω-3混合物產品治療的患者，因為患者被不當使用這些藥物來治療心血管風險。儘管這些產品可能會影響生物標記，但對數萬名患者進行的大規模、控制良好的心血管結果試驗未能證明心血管事件的減少。改變脂質生物標記已不再足夠，並且會給提供者和患者帶來一種虛假的安全感。許多患者需要接受已證實可以減少心血管事件的治療。為這些患者提供更多幫助應該包括使用 VAZKEPA。

And this is not just our opinion. When we look at VASCEPA and VAZKEPA, it's a proven product backed by science and strong support across the global medical community. Over the last 10 years, more than 300 scientific publications have been generated confirming the unique attributes of VASCEPA and VAZKEPA anchored by the landmark REDUCE-IT trial and confirming that VASCEPA and VAZKEPA in combination with the statin provides an important option for patients globally who need to further reduce their risk of a cardiovascular event.

這不只是我們的觀點。當我們看到 VASCEPA 和 VAZKEPA 時，我們發現它是一種經過驗證的產品，有科學依據並得到全球醫學界的大力支持。在過去的 10 年中，已有 300 多篇科學出版物發表，證實了 VASCEPA 和 VAZKEPA 的獨特屬性，這些屬性以具有里程碑意義的 REDUCE-IT 試驗為基礎，並證實了 VASCEPA 和 VAZKEPA 與他汀類藥物聯合使用為全球需要進一步降低心血管事件風險的患者提供了重要選擇。

As a result, this science has been recognized by the global medical community, evidenced by the more than 50 leading medical societies across 20 countries that have issued guidelines and scientific statements supporting the therapeutic value of icosapent ethyl to address cardiovascular risk. In addition, thousands of scientific leaders and prescribers as well as numerous payer and reimbursement authorities around the world support the product.

因此，這項科學已獲得全球醫學界的認可，來自 20 個國家的 50 多個領先的醫學協會已發布指南和科學聲明，支持二十碳五烯酸乙酯在治療心血管風險方面的治療價值。此外，全球數以千計的科學領袖和處方人員以及眾多付款人和報銷機構都支持該產品。

And the scientific community continues to build on the existing science by conducting and publishing further studies and analyses of its utility in certain at-risk subpopulations and continued ongoing work to further elucidate the mechanism of action. We also know that this product has significant value and a long runway for growth, particularly in Europe, with recently granted IP out to 2039.

科學界將繼續在現有科學的基礎上，進行和發表進一步的研究和分析其在某些高危險群中的效用，並繼續開展工作以進一步闡明其作用機制。我們也知道該產品具有巨大的價值和長期的成長空間，特別是在歐洲，最近授予的智慧財產權將持續到 2039 年。

Our confidence is evidenced by the experience we've had with the product over the last five years in the US since the FDA approval of the cardiovascular risk reduction indication. In the US, following the readout of the REDUCE-IT trial, the reception was remarkable for this product by the scientific community and the potential to positively impact millions of patients with VASCEPA.

自從 FDA 批准用於降低心血管風險以來，我們在美國過去五年對該產品的體驗證明了我們的信心。在美國，REDUCE-IT 試驗結果公佈後，科學界對該產品的反應十分熱烈，並有可能對數百萬 VASCEPA 患者產生正面影響。

The REDUCE-IT data generated incredible demand for VASCEPA. Prescriptions increased significantly and product revenue rose substantially. We witnessed a greater than 50% increase in the number of prescribers totaling 200,000 in the US, resulting in more than 80% growth in new prescriptions in the first-year post publication of REDUCE-IT.

REDUCE-IT 數據對 VASCEPA 產生了巨大的需求。處方大幅增加，產品收入大幅上升。我們看到美國開處方人數增加了 50% 以上，達到 20 萬人，導致 REDUCE-IT 發布後第一年的新處方數量增加了 80% 以上。

This history of uptake and market response provides evidence that with time to promote and educate and supported by outstanding execution, providers respond favorably to VASCEPA as a therapy that can benefit their patients. If we apply that experience and learnings from the US to Europe, we know VAZKEPA has the potential to grow substantially with a large eligible patient population based on the approved label and the extended runway out to 2039. We know we're still in the early days of this opportunity in Europe.

這項採用和市場反應的歷史證明，隨著時間的推移和出色的執行，供應商對 VASCEPA 的認可度較高，認為它是一種可以使患者受益的治療方法。如果我們將美國的經驗和知識應用到歐洲，我們知道，基於批准的標籤和延長至 2039 年的運行時間，VAZKEPA 有潛力憑藉大量符合條件的患者群體實現大幅增長。我們知道，我們在歐洲仍處於這一機會的早期階段。

Our teams in many markets in Europe are just now beginning the education process and we have only scratched the surface of our pricing and reimbursement and launch progress in many markets. To date, we've unlocked access and launched in 8 European countries, but this only represents about half the market access opportunity in Europe. We've learned that launching in Europe takes time and there remains significant potential to further expand access to VAZKEPA for at-risk patients in a number of additional European countries.

我們在歐洲許多市場的團隊現在才剛開始教育過程，我們在許多市場的定價、報銷和發布進度才剛開始。到目前為止，我們已經解鎖了8個歐洲國家的市場准入機會，但這只佔歐洲市場准入機會的一半左右。我們了解到，在歐洲推出 VAZKEPA 需要時間，並且在更多歐洲國家進一步擴大高風險患者獲得 VAZKEPA 的機會仍有很大潛力。

The same holds true for many markets in the rest of the world and we've been opportunistic in many of these markets. We currently have nine partners who we're collaborating with across a number of markets and we're in the early stages of obtaining reimbursement and launching in some of these important regions. As for the US, the company benefits from continued cash generation from the brand tail as we continue to focus on extracting maximum value. The cash generated from our U.S. sales continues to support operations for the company.

世界其他地區的許多市場也是如此，我們在許多此類市場中都抓住了機會。我們目前擁有九個合作夥伴，遍及多個市場，我們正處於獲得報銷和在一些重要地區推出產品的早期階段。至於美國，由於我們繼續專注於獲取最大價值，公司將從品牌尾部持續產生的現金中受益。我們在美國銷售產生的現金繼續支持公司的營運。

In summary, the combination of the current unmet need for patients, the strength and extent of scientific community support of clinical data, extended runway in Europe and the opportunity for expanded access as well as the proven uptake and clear impact on reducing cardiovascular risk around the world translate into a growth and value opportunity for VASCEPA/VAZKEPA that we remain laser-focused on further expanding every single day.

總而言之，目前患者尚未滿足的需求、科學界對臨床數據支持的力度和程度、歐洲延長的運行時間、擴大准入的機會以及已被證實的接受度和對降低全球心血管風險的明顯影響，這些因素結合起來，為 VASCEPA/VAZKEPA 帶來了增長和價值機會，我們每天都將高度專注於進一步擴大這一機會。

And to that end, our focus is clear: to prioritize execution and performance while urgently evaluating all opportunities to expand the impact of VAZKEPA to millions of patients worldwide. That's our commitment to patients, providers, payers and of course, to shareholders.

為此，我們的重點很明確：優先執行和表現，同時緊急評估所有機會，將 VAZKEPA 的影響力擴大到全球數百萬名患者。這是我們對患者、供應商、付款人以及股東的承諾。

Now let me turn to some of the operational highlights our team has delivered in the third quarter and year-to-date. Turning to slide 6. Our recent progress provides yet further evidence that the value and opportunity of VASCEPA/VAZKEPA is being recognized and validated. In Europe, our focus has been on accelerating revenue in key launch markets while advancing pricing and reimbursement processes.

現在，讓我來介紹一下我們的團隊在第三季和今年迄今為止所取得的一些營運亮點。翻到幻燈片 6。我們最近的進展進一步證明，VASCEPA/VAZKEPA 的價值和機會正在得到認可和驗證。在歐洲，我們的重點是加速主要發行市場的收入，同時推動定價和報銷流程。

Earlier this year, as mentioned, our team successfully advanced our intellectual property position in Europe, extending our IP for VAZKEPA through 2039. This is important as it extends the runway to realize the true value of this product for patients in Europe. On the commercialization front, while our revenues continue to grow, powered by continued sales growth in the UK, Spain and in Central and Eastern Europe markets, we're in the early stages and know we must accelerate growth where VAZKEPA has been launched.

正如前文所提到的，今年早些時候，我們的團隊成功提升了我們在歐洲的智慧財產權地位，將 VAZKEPA 的智慧財產權延長至 2039 年。這很重要，因為它延長了實現該產品對歐洲患者的真正價值的道路。在商業化方面，雖然我們的收入持續成長，得益於英國、西班牙以及中歐和東歐市場的持續銷售成長，但我們仍處於早期階段，並且知道我們必須加速 VAZKEPA 上市地點的成長。

We've also continued to advance our pricing and reimbursement efforts to extend access to VAZKEPA for more patients across Europe. Year-to-date, we have now secured pricing and reimbursement in Greece and Portugal. And in Italy, our team has continued to take steps with pricing and reimbursement authorities and we hope to be in a position to share news soon in this key market.

我們也持續推進定價和報銷力度，以便讓更多歐洲患者能夠獲得 VAZKEPA 治療。今年迄今為止，我們已經確保了希臘和葡萄牙的定價和報銷。在義大利，我們的團隊繼續與定價和報銷部門採取步驟，我們希望能夠很快在這個關鍵市場分享新聞。

Turning to the US. Our team remains focused on retaining icosapent ethyl market leadership for VASCEPA and extracting as much value as possible for this business despite additional generic competition and pricing challenges.

轉向美國。儘管面臨額外的仿製藥競爭和定價挑戰，我們的團隊仍致力於保持 VASCEPA 在二十碳五烯酸乙酯市場的領導地位，並為該業務挖掘盡可能多的價值。

Through the first three quarters of the year, VASCEPA has maintained a leadership position with greater than 50% share of the IPE market. We continue to follow the competitive landscape as well as reimbursement and pricing dynamics and we'll continue efforts to maintain a leadership position. As an important reminder, we've been sustaining a high level of market share capture with VASCEPA following the shift to a generic market in 2020, a noteworthy track record due to the unique attributes of this product. The US market remains the main source of revenue for the company and currently the primary funding source in support of our expansion plans.

今年前三個季度，VASCEPA 一直保持領先地位，佔據 IPE 市場 50% 以上的份額。我們將繼續關注競爭格局以及報銷和定價動態，並將繼續努力保持領導地位。重要的提醒是，自 2020 年轉向仿製藥市場以來，我們一直憑藉 VASCEPA 保持較高的市場份額，這一成績得益於該產品的獨特屬性。美國市場仍然是公司的主要收入來源，目前也是支持我們擴張計畫的主要資金來源。

And of course, we also continue to assess the optimal time to launch an authorized generic into the US market. Across the rest of the world, our focus has been to extend access to VASCEPA/VAZKEPA through partnerships, growing the sustainable opportunity across these markets. We're making important progress in this effort through pricing and reimbursement processes and commercialization with our partners. Let me touch on 2 examples.

當然，我們也將繼續評估將授權仿製藥引入美國市場的最佳時機。在世界其他地區，我們的重點是透過合作擴大 VASCEPA/VAZKEPA 的覆蓋範圍，從而增加這些市場的永續發展機會。我們透過定價和報銷流程以及與合作夥伴的商業化在這項努力中取得了重要進展。讓我舉兩個例子。

In Australia, our partner, CSL Seqirus, secured Australia's pharmaceutical benefit scheme price listing for VAZKEPA, unlocking public access to the product for patients in that market. CSL is now launching VAZKEPA and we expect to realize the impact of such partnership-based sales beginning in 2025. And in China, through the first 9 months of 2024, our partner, Eddingpharm, received regulatory approval for VASCEPA for the cardiovascular risk reduction indication, which is a significant milestone for the drug, given that China is the largest market for cardiovascular-related products. Edding is following up that success with continued efforts to secure a national reimbursement drug listing in China. Supporting all of our commercialization and expanded access efforts worldwide are our medical affairs, R&D and regulatory teams who expertly and tirelessly advocate for and conduct the critical work to advance the science behind VASCEPA and VAZKEPA.

在澳大利亞，我們的合作夥伴 CSL Seqirus 為 VAZKEPA 獲得了澳洲藥品福利計畫價格清單，讓該市場的患者可以獲得該產品。CSL 目前正在推出 VAZKEPA，我們預計從 2025 年開始實現這種基於合作夥伴關係的銷售的影響。在中國，到 2024 年前 9 個月，我們的合作夥伴 Eddingpharm 將獲得 VASCEPA 用於降低心血管風險適應症的監管批准，這對該藥物來說是一個重要的里程碑，因為中國是最大的心血管相關產品市場。艾丁正在繼往開來，繼續努力爭取在中國取得國家健保藥品名單。我們的醫療事務、研發和監管團隊為我們在全球範圍內的所有商業化和擴大可及性努力提供支持，他們專業且不知疲倦地倡導和開展關鍵工作，以推進 VASCEPA 和 VAZKEPA 背後的科學。

Nearly 5 years from the approval of VASCEPA in the U.S. for cardiovascular risk reduction, we and others are continuing to generate meaningful data that helps the clinical community further understand the value of VASCEPA and VAZKEPA to reduce cardiovascular risk when used as an adjunct to statin therapy to benefit patients further. So far this year, our teams, along with KOL partners have presented more than 25 publications and abstracts that both individually and in aggregate help to advance an ever-broadening understanding of the science and value of IPE and EPA.

距離 VASCEPA 在美國獲準用於降低心血管風險已有近 5 年，我們和其他人正在繼續產生有意義的數據，幫助臨床界進一步了解 VASCEPA 和 VAZKEPA 在作為他汀類藥物輔助治療時降低心血管風險的價值，從而進一步使患者受益。今年到目前為止，我們的團隊與 KOL 合作夥伴已經提交了 25 多種出版物和摘要，這些出版物和摘要無論是單獨還是總體上都有助於加深對 IPE 和 EPA 的科學性和價值的了解。

Two recent examples of this important study drumbeat include recent abstracts and presentations at the European Society of Cardiology meeting in August and the European Association for the Study of Diabetes meeting in September. Importantly, this recent research has provided new insights on EPA's potential effect on elevated levels of lipoprotein-a thought to be a key factor in cardiovascular risk and mortality for at-risk patients.

這項重要研究成果的兩個最新例子包括 8 月歐洲心臟病學會會議和 9 月歐洲糖尿病研究協會會議上的最新摘要和報告。重要的是，這項最新研究對 EPA 對升高的脂蛋白水平的潛在影響提供了新的見解 - 脂蛋白水平升高被認為是心血管風險和高風險患者死亡的關鍵因素。

And our team will be supporting three abstracts at the upcoming American Heart Association meeting in November. We intend to continue to further advance this evidence on the utility and value of VASCEPA and VAZKEPA and IPE. Our teams have also made regulatory progress so far this year with approvals for our product for cardiovascular risk reduction in South Africa and China. In summary, it's our obligation to get VASCEPA/VAZKEPA into the hands of as many patients around the world as possible. We've made progress under sometimes difficult market and reimbursement challenges, but as more stakeholders become increasingly educated on the strength of the VAZKEPA clinical data and what it means for patient care, our confidence in this product's global potential continues to grow.

我們的團隊將在 11 月即將舉行的美國心臟協會會議上支援三篇摘要。我們打算繼續進一步推進有關 VASCEPA、VAZKEPA 和 IPE 的實用性和價值的證據。今年到目前為止，我們的團隊在監管方面也取得了進展，我們的降低心血管風險的產品已獲得南非和中國的批准。總之，我們有義務讓盡可能多的全球患者能夠使用 VASCEPA/VAZKEPA。我們在有時困難的市場和報銷挑戰下取得了進展，但隨著越來越多的利益相關者越來越了解 VAZKEPA 臨床數據的實力及其對患者護理的意義，我們對該產品全球潛力的信心不斷增強。

Now let me turn the call over to Pete Fishman, who will review our third-quarter 2024 financial results. Pete?

現在，我將把電話轉給 Pete Fishman，他將審查我們 2024 年第三季的財務表現。皮特？

Thank you, Aaron. Turning to Slide 8. Before I begin, I think it is important to introduce myself since I have assumed the role of Principal Financial and Accounting Officer of the company. I've served as the company's Global Controller since October 2022 and held roles of increasing responsibility within Amarin's finance team since 2019. Overall, I come into this role with nearly 20 years' experience in various roles in finance, including accounting, financial reporting, tax and audit.

謝謝你，亞倫。翻到幻燈片 8。在開始之前，我認為自我介紹很重要，因為我已經擔任公司財務會計長。我自 2022 年 10 月起擔任該公司的全球財務總監，並自 2019 年以來在 Amarin 的財務團隊中擔任越來越重要的職務。總的來說，我在擔任這個職位之前已經擁有近 20 年的財務領域各個職位的工作經驗，包括會計、財務報告、稅務和審計。

The transition has been seamless, and I look forward to continuing to work with our tremendous global finance team in my new role. Turning now to the numbers. In the third quarter of 2024, Amarin reported total net revenue of $42.3 million, including net product revenue of $41.9 million and $400,000 of licensing and royalty revenues compared to total net revenue of $66.1 million in the third quarter of 2023. U.S. product revenue was $30.6 million in the third quarter of 2024 compared to $62.4 million in the third quarter of 2023.

過渡非常順利，我期待在新的職位上繼續與我們出色的全球財務團隊合作。現在來談談數字。2024 年第三季度，Amarin 報告總淨收入為 4,230 萬美元，其中包括 4,190 萬美元的淨產品收入和 40 萬美元的許可和特許權使用費收入，而 2023 年第三季的總淨收入為 6,610 萬美元。2024 年第三季美國產品營收為 3,060 萬美元，而 2023 年第三季為 6,240 萬美元。

This decline was driven by lower net selling price due to the generic competition in the market and a decrease in volume due to CVS moving from exclusive to not covered. Despite the revenue decline, the U.S. business continues to deliver significant cash. Product revenue this quarter also reflects European net product revenue of $4.3 million, a $3.5 million increase over the prior year period and an $800,000 increase compared to last quarter, both driven primarily by revenue growth from Spain and the U.K. Third quarter 2024 cost of goods sold was $26 million compared to $36.2 million in the prior year period.

造成這一下降的原因是由於市場上仿製藥的競爭導致淨售價下降，以及 CVS 從獨家經營轉為不覆蓋導致銷售下降。儘管收入下降，美國業務仍繼續帶來大量現金。本季的產品收入也反映了歐洲淨產品收入 430 萬美元，比去年同期增加 350 萬美元，比上一季增加 80 萬美元，這主要得益於西班牙和英國的收入增長。

Gross margin was 38% compared to 64% in the prior year period, excluding inventory restructuring charges in the third quarter of 2023. This decline is due to a decline in net selling price in the US. Total operating expenses in the third quarter of 2024 were $41.4 million, comprised of $36.9 million in SG&A and $4.5 million in R&D expenses, which is a reduction of approximately $10 million compared to the prior year period due to ongoing cost optimization initiatives.

2023 年第三季度，若不含庫存重組費用，毛利率為 38%，去年同期為 64%。這一下降是由於美國淨銷售價格下降造成的。2024 年第三季的總營運費用為 4,140 萬美元，其中包括 3,690 萬美元的銷售、一般及行政費用和 450 萬美元的研發費用，由於持續的成本優化舉措，與去年同期相比減少了約 1,000 萬美元。

Turning to the bottom line. We reported a GAAP net loss of $25.1 million for the third quarter of 2024 compared to a $19.3 million loss in the prior year period, reflecting the impact from the US generic market. Let me now turn to slide 9 and our efforts and results in controlling costs and effectively managing our cash. As of September 30, 2024, Amarin reported aggregate cash and investments of $306 million, which includes receiving the $15 million Edding CVRR milestone payment in the quarter and no debt. While we continue to navigate the ongoing challenges to our US product revenues, we have successfully maintained a stable cash position over the last nine quarters.

轉向底線。我們報告 2024 年第三季的 GAAP 淨虧損為 2,510 萬美元，而去年同期的虧損為 1,930 萬美元，反映了美國仿製藥市場的影響。現在我翻到第 9 張投影片，介紹我們在控製成本和有效管理現金方面的努力和成果。截至 2024 年 9 月 30 日，Amarin 報告的現金和投資總額為 3.06 億美元，其中包括本季收到的 1500 萬美元 Edding CVRR 里程碑付款，並且沒有債務。雖然我們繼續應對美國產品收入面臨的持續挑戰，但我們在過去九個季度中成功保持了穩定的現金狀況。

Fundamental to that success has been and will continue to be a commitment to balancing a combination of preserving cash, managing costs and pursuing channels to expand product revenue. Now I'll turn the call back over to Aaron for closing remarks before we begin the Q&A. Aaron?

這項成功的基礎一直是並將繼續是致力於平衡保留現金、管理成本和尋求擴大產品收入的管道。現在，在我們開始問答環節之前，我將把電話轉回給 Aaron，請他作結束語。阿倫？

Thanks, Pete. Turning to slide 11. As we've shared this evening, there's significant long-term value in VASCEPA and VAZKEPA. This is clear both from what Amarin has delivered as well as what the external world has expressed in terms of validation of the science, the impact and the value that our product can provide to patients.

謝謝，皮特。翻到第 11 張投影片。正如我們今晚所分享的，VASCEPA 和 VAZKEPA 具有重要的長期價值。從 Amarin 所提供的產品以及外界對我們的產品能夠為患者提供的科學性、影響力和價值的驗證來看，這一點是顯而易見的。

As we move forward, our focus is simple and clear: to harness the proven attributes of the product to expand access for patients. We'll focus on the strength of and opportunities for this product. Over 10 years of science and clinical data, including more than 300 publications on VASCEPA and the backing of 50 medical societies around the world, recognizing the value of the product. The significant experience and support this product has gained through its commercialization in the US, the extended IP position in Europe out to 2039, the unmet need globally to reduce cardiovascular risk as cardiovascular disease remains the number one killer worldwide, the multiple untapped markets in Europe and the rest of the world where access can be further opened beyond what we've achieved so far and accelerating usage in key launch markets, all in the name of our commitment to maximize the value potential at a faster pace.

隨著我們不斷前進，我們的重點簡單而明確：利用產品已證實的屬性來擴大患者的用藥途徑。我們將重點放在該產品的優勢和機會。超過 10 年的科學和臨床數據，包括超過 300 篇關於 VASCEPA 的出版物和全球 50 個醫學協會的支持，認可了該產品的價值。該產品透過在美國商業化獲得了重要的經驗和支持，在歐洲將知識產權地位延長至2039年，由於心血管疾病仍然是全球第一大殺手，因此在全球範圍內降低心血管風險的未滿足需求，在歐洲和世界其他地區有多個尚未開發的市場，這些市場的准入可以進一步開放，超越我們迄今取得的成就，並在主要發布市場有多個尚未開發的市場，這些市場的准入可以進一步開放，超越我們迄今取得的成就，並在主要發布市場加速使用，一切都是為了最大化市場的潛力。

We also remain fully committed to our public listing. It's very important for us as well as to our shareholders. In addition to continuing to drive the business, there are a number of mechanisms we're considering that would help us regain Nasdaq compliance.

我們也將繼續全力致力於我們的公開上市。這對我們和我們的股東來說都非常重要。除了繼續推動業務發展之外，我們還在考慮多種機制來幫助我們重新獲得納斯達克合規性。

Overall, we're making progress on our core priorities, but there's much more work that needs to be done quickly. We understand the need to accelerate performance to realize the potential of VAZKEPA and VASCEPA and that's what I and the entire team at Amarin are committed to delivering.

總體而言，我們在核心優先事項上取得了進展，但仍有許多工作需要迅速完成。我們了解需要加快效能以實現 VAZKEPA 和 VASCEPA 的潛力，而這正是我和 Amarin 整個團隊致力於實現的目標。

Before we turn to Q&A, I'd like to thank our Amarin colleagues and partners around the world for their continued commitment and dedication. Your efforts are sincerely appreciated and very important for patients around the world.

在我們進入問答環節之前，我想感謝我們在世界各地的 Amarin 同事和合作夥伴的持續承諾和奉獻。我們真誠地感謝您的努力，這對全世界的患者來說非常重要。

Thanks for your efforts. And with that, operator, let's begin the Q&A portion of the call.

謝謝你的努力。接線員，讓我們開始通話的問答部分。

(Operator Instructions)

（操作員指令）

Roanna Ruiz, [RBS].

羅安娜·魯伊斯，[蘇格蘭皇家銀行]。

This is Maizi Ali Mohamed at Leerink Partners on for Roanna Ruiz. Just two from us. So the first, given the increasing rebating in '24 for VASCEPA, what are your expectations for net pricing pressure kind of going forward in the short term? And then secondly, are there any additional trials or data points that you believe could enable greater reimbursement coverage for VAZKEPA in the EU and/or China?

這是 Leerink Partners 的 Maizi Ali Mohamed，為 Roanna Ruiz 撰稿。就我們兩個了。那麼首先，鑑於 24 年 VASCEPA 的回扣不斷增加，您對短期內未來的淨定價壓力有何預期？其次，您認為是否有任何額外的試驗或數據點可以使 VAZKEPA 在歐盟和/或中國獲得更大的報銷覆蓋範圍？

First of all, thank you for your questions. We appreciate it. Thanks for taking the time to listen this evening. Regarding rebates and rebate pressure in the U.S., as you know, we've been in an increasingly generic market with the brand in the U.S. since November of 2020. The fact that we've maintained a 50% share of our volume speaks to the great work done by the team and the uniqueness of the product. In that, of course, the pressures have been increasing.

首先感謝您的提問。我們對此表示感謝。感謝您今晚抽出時間收聽。關於美國的回扣和回扣壓力，如您所知，自 2020 年 11 月以來，我們在美國一直處於一個越來越通用的品牌市場。我們能夠保持 50% 的銷售份額，這證明了團隊的出色工作和產品的獨特性。當然，壓力也一直在增加。

There are now eight generic companies that are marketed in the US. So we do expect rebates to continue to need to go up. But that being said, we've maintained our exclusives. That's helped us maintain our volume. We still believe we can compete profitably in the US and we'll continue to do that for the foreseeable future. Of course, it's a generic market. So it's something that as time goes on, those pressures would increase. But each year, every time we get to this point in time, we say the same thing and we've managed to maintain that 50% share. And hopefully, that will continue going forward.

目前，共有 8 家仿製藥公司在美國上市。因此我們確實預計回扣將繼續上漲。但話雖如此，我們仍然保持著我們的獨家經營權。這有助於我們維持銷售量。我們仍然相信我們能夠在美國獲得盈利，並且在可預見的未來我們將繼續這樣做。當然，這是一個通用市場。因此，隨著時間的推移，這些壓力就會增加。但每年，每當我們到達這個時間點，我們都會說同樣的話，我們成功地保持了 50% 的份額。希望這種情況能夠持續下去。

In terms of trials or markers to help increase reimbursement in Europe, I'm joined here by Dr. Steve Ketchum, he's our Executive Vice President of R&D and Chief Scientific Officer. Steve, do you want to touch on that?

關於有助於提高歐洲報銷額的試驗或標記，我與史蒂夫·凱徹姆博士一起參加了此次會議，他是我們的研發執行副總裁兼首席科學官。史蒂夫，你想談談這個嗎？

Yes, certainly. So as we continue to support the brand globally, including in Europe, we continue to conduct various subgroup analyses in high-risk patient populations, which not only interesting to the clinical community in terms of peer-reviewed publications and congress presentations, but also sometimes in pricing and reimbursement context to provide that context in patients who are difficult to treat and clearly at high cardiovascular risk. There are -- obviously, over time, there are other data points from other research groups that we feel continue to support that highly purified EPA is efficacious. And we continue to keep an eye on those and to fold them into our story as well.

是的，當然。因此，在我們繼續在全球範圍內（包括歐洲）支持該品牌的同時，我們將繼續在高風險患者群體中開展各種亞組分析，這不僅在同行評審出版物和會議報告方面引起了臨床界的興趣，而且有時在定價和報銷方面也為難以治療且明顯具有高心血管風險的患者提供背景信息。顯然，隨著時間的推移，我們認為其他研究小組提供的其他數據點將繼續支持高度純化的 EPA 是有效的。我們會繼續關注這些內容並將其融入我們的故事中。

And I'll just build on that because it's a good question. So it would be -- certainly, if there was some silver bullet marker or some additional data that would add to what we already have and accelerate the process, we'd certainly be looking at that. The good news for us is we're well armed. We have tremendous clinical data now. And part of what we're experiencing in Europe with reimbursement is not really unique to Amarin. It's a challenging market dynamic for reimbursement for even some of the biggest companies with the biggest brands in Europe.

我將在此基礎上進一步探討，因為這是一個好問題。所以，當然，如果有一些靈丹妙藥標記或一些額外的數據可以補充我們已經擁有的東西並加速這一進程，我們肯定會考慮的。對我們來說好消息是我們的裝備精良。我們現在擁有大量的臨床數據。我們在歐洲遇到的報銷問題並不是 Amarin 獨有的。即使對於歐洲一些擁有最大品牌的最大公司來說，報銷的市場動態也是充滿挑戰的。

So we feel very well armed with what we have, managing the process as best we can. We're always looking for ways to improve. We've certainly done it in the last year or so, we've focused in on acute coronary syndrome patients. So they're a higher-risk patient population, more costly, more easily identified, more likely to get -- to have additional events, more likely to get combination therapy.

因此，我們感到自己已經充分發揮了現有資源，並盡最大努力管理這項進程。我們一直在尋找改進的方法。我們在過去一年左右確實這樣做了，我們專注於急性冠狀動脈綜合徵患者。因此，他們屬於高風險患者群體，治療費用更高、更容易識別、更容易發生其他事件、更有可能接受聯合治療。

And that seems to be helping accelerate things not only from a reimbursement perspective, but from a launch uptake perspective. So we're confident in what we have. We realize that it's never fast enough, but I think the team is executing well and we look forward to more progress. As I mentioned in the prepared comments, hopefully, we have more to say about Italy fairly soon. We look forward to that.

這似乎不僅從報銷的角度，而且從啟動吸收的角度都有助於加速進程。因此我們對我們所擁有的一切充滿信心。我們意識到速度永遠不夠快，但我認為團隊執行得很好，我們期待取得更多進展。正如我在準備好的評論中提到的那樣，希望我們很快就能更多地談論義大利。我們對此充滿期待。

Jessica Fye, JPMorgan.

摩根大通的傑西卡·菲伊 (Jessica Fye)。

So we noticed that there is some momentum in the rest of the world in terms of revenue. Can you please give us some color on what is driving that? And then as well as EU, can you talk about the growth dynamic there? And then for the net price for VASCEPA in US, how do we think about the net price going forward? Do you think this is stabilized? Or like do you think it's going to continue to erode?

因此，我們注意到世界其他地區在收入方面也呈現一定的成長動能。您能否向我們詳細解釋一下這現象的背後原因？那麼，還有歐盟，您能談談那裡的成長動態嗎？那麼對於美國 VASCEPA 的淨價，我們又該如何看待未來的淨價呢？您認為這已經穩定了嗎？或者您認為它會繼續侵蝕嗎？

Sure. So regarding the momentum in the rest of the world, as we mentioned, we're early in a number of countries with launch, with reimbursement, with a number of partners and a number of regions that we're just getting going. So fortunately, this is a product we know from the US experience that when you educate, when you have the chance to promote that physicians respond well. It doesn't always happen fast in every market, but it happens.

當然。至於世界其他地區的發展勢頭，正如我們所提到的，我們在許多國家都處於推出該產品的早期階段，提供報銷服務，與一些合作夥伴建立了合作夥伴關係，但在一些地區我們才剛剛起步。因此幸運的是，我們從美國的經驗中知道，當你進行教育時，當你有機會推廣時，醫生會做出良好的反應。雖然這種現像不會在每個市場都快速發生，但確實會發生。

And the good news is we have a number of partners. We now have nine partnerships in rest of the world. And those -- in some of those regions, they are starting to kick in. So we're starting to see some of that momentum. Hopefully, we'll see some of our partners make greater progress.

好消息是我們擁有多個合作夥伴。我們目前在世界其他地區有九個合作夥伴。在某些地區，這些措施已開始發揮作用。因此我們開始看到一些這樣的勢頭。希望我們能夠看到我們的一些合作夥伴取得更大的進步。

Australia just got started for one. China just got started with the cardiovascular risk indication. And hopefully, that will accelerate being the big market that it is. And hopefully, that will continue. The Europe growth dynamics, we've been encouraged by both UK and Spain and maybe for slightly different reasons. U.K., we launched close to two years ago.

澳洲才剛開始這一進程。中國才剛開始心血管風險指標的評估。希望這能加速其成為大市場。希望這種情況能夠持續下去。歐洲的成長動力讓我們受到英國和西班牙的鼓舞，但原因可能略有不同。英國，我們在兩年前就推出了該產品。

We changed our strategy, made a number of changes in the organization within the last year and we're seeing that those changes have made a difference and we're seeing a greater acceleration in growth. Spain was, from our perspective, from launch on and now we have Portugal as well for reimbursement, very good execution. Well, the market is receiving it very well.

我們改變了策略，去年對組織進行了一些變革，我們看到這些變革已經產生了影響，我們看到了更快的成長速度。從我們的角度來看，從推出以來西班牙的報銷計劃，以及現在葡萄牙的報銷計劃，執行都非常好。嗯，市場對此反應很好。

We're seeing early signs of impact of education and promotion and growth and we're excited to see what Spain can do going forward. Hopefully, we have good news on Italy going forward and as well as continued good news in some of these, again, back to the rest of the world, some of the rest of the world partnerships. So the foundation, we think, is getting stronger. And hopefully, we see more countries come online in the near term. In terms of the net price, I'm going to turn it over to Pete to address that in the US.

我們看到了教育、推廣和成長影響的早期跡象，我們很高興看到西班牙在未來可以取得的進展。希望我們能在未來獲得有關義大利的好消息，同時也能繼續獲得有關世界其他地區、世界其他地區一些夥伴關係的好消息。因此我們認為基礎正在變得越來越牢固。我們希望在不久的將來能看到更多國家上線。至於淨價，我將交給 Pete 在美國處理。

Sure. Thanks, Aaron. I think just building off of what you said in the last question in terms of net price, being in a generic environment, we are seeing price pressure working with our partners and also the mix in terms of our business moving more towards Medicare Part D from commercial as a result of the CVS going from exclusive to not covered. Medicare is at a higher discounted rate. And so we are seeing some pricing pressure there. And just given the environment, we expect to see that pressure continue moving forward.

當然。謝謝，亞倫。我認為，就您在上一個問題中提到的淨價而言，在通用環境中，我們看到與合作夥伴合作時面臨的價格壓力，而且由於 CVS 從獨家變為不覆蓋，我們的業務更多地從商業轉向 Medicare Part D。醫療保險的折扣率更高。因此我們看到那裡存在一些定價壓力。考慮到當前的環境，我們預計這種壓力將持續增加。

(Operator Instructions)

（操作員指令）

Paul Choi, Goldman Sachs.

高盛的保羅·崔（Paul Choi）。

I wanted to ask about prioritization of capital. Your cash position has held relatively steady for several quarters now, but I think you've also discussed a share repurchase program. I just wanted to ask on the status of that. And secondly, as you think about business development opportunities and looking for potential pipeline assets, can you maybe just comment on how you're seeing the landscape and your capacity there?

我想問一下資本優先的問題。您的現金狀況已經連續幾季保持相對穩定，但我認為您也討論過股票回購計劃。我只是想詢問一下該情況。其次，當您考慮業務發展機會和尋找潛在的管道資產時，您能否評論一下您如何看待那裡的情況和產能？

Sure. Thanks, Paul. Thanks for joining us. So prioritization of capital and on the repurchase, Pete, do you want to address both of those?

當然。謝謝，保羅。感謝您的加入。那麼，Pete，優先考慮資本和回購，你想解決這兩個問題嗎？

Sure. So in terms of the repurchase, as you know, we did get approval to initiate a repurchase program. We have that ability to initiate it for 10 years. And similar to what we said last quarter, we're continuing to monitor the business and market dynamics to determine whether we will commence that program. At this point, we have not repurchased any shares.

當然。因此就回購而言，如您所知，我們確實獲得了啟動回購計畫的批准。我們有能力啟動這項進程 10 年。與我們上個季度所說的類似，我們將繼續監控業務和市場動態，以確定是否啟動該計劃。到目前為止，我們尚未回購任何股票。

In terms of just general kind of cash prioritization, we're always continuing to be mindful of our cash balance. We have been neutral to cash positive for nine straight quarters. During this quarter, we did receive the $15 million Edding CVRR milestone payment. While we don't expect to have one -- another material onetime milestone in the next quarter, we still are mindful of the cash and monitoring it and making sure that our investments are prudent and that we are always looking for ways to find cost optimization.

就一般的現金優先順序而言，我們始終關注我們的現金餘額。我們已經連續九個季度對現金持中立態度。本季度，我們確實收到了 1500 萬美元的 Edding CVRR 里程碑付款。雖然我們不期望在下個季度實現另一個重大的一次性里程碑，但我們仍然關注現金並對其進行監控，確保我們的投資是審慎的，並且我們一直在尋找優化成本的方法。

And then the third question on business development and any consideration of looking at additional assets. Right now our focus is on executing with VAZKEPA and VASCEPA. I think that we are very optimistic about our ability to grow that. We're starting to see that momentum that has been hard fought. We know that we need to -- we'd like to get on firmer footing. When it comes to that growth, the cash we have, as you can see and you followed us the last few years, we've been very judicious about managing our cash and our operating expenses.

第三個問題是關於業務發展以及對尋找額外資產的考量。目前我們的重點是執行 VAZKEPA 和 VASCEPA。我認為我們對於我們發展這一目標的能力非常樂觀。我們開始看到這種來之不易的勢頭。我們知道我們需要——我們希望站穩腳跟。說到成長，我們擁有的現金，正如您所看到的，並且在過去幾年中您一直關注著我們，我們一直非常明智地管理我們的現金和營運費用。

We've had several restructurings, including one last year with a singular focus to grow VAZKEPA in Europe because that market is enormous. We have till 2039 for a runway now, thanks to significantly expanded IP protection. And those markets, we've barely scratched the surface. And in some of those key markets, we haven't even gotten on the market yet.

我們經歷過幾次重組，包括去年的一次重組，重點是在歐洲發展 VAZKEPA，因為那裡的市場非常龐大。由於智慧財產權保護範圍大幅擴大，我們現在可以在 2039 年之前建造跑道。而對於這些市場，我們僅僅觸及了表面。而在一些關鍵市場，我們甚至還沒有進入市場。

Again, not unusual for Europe and for a lot of companies, not that unique to Amarin, but we have a product that has significant upside and we're determined to find a way to get it in more patients' hands any way that we can. So that's our focus right now. In the future, we'll consider putting another product in the bag if we get to that point. But right now we're pretty laser-focused.

再說一次，對於歐洲和許多公司來說這並不罕見，對 Amarin 來說也不獨特，但我們的產品具有顯著的優勢，我們決心盡一切可能讓更多的患者得到它。這就是我們現在的重點。將來，如果我們達到那個程度，我們會考慮將另一種產品放入包中。但現在我們非常專注。

This concludes the Q&A portion of the call. I would now like to turn the floor back to management for any closing remarks.

本次通話的問答部分到此結束。現在我想將發言權交還給管理階層，請他們做最後發言。

Yes. Thank you, John. First of all, thanks, everybody, for joining us this evening. We appreciate it. Just as a reminder, on November 14, we'll be hosting a virtual analyst and investor event. And what we'll do is we'll focus on the VASCEPA and VAZKEPA franchise, focusing in on the dynamics for some of the key geographies that represent the future of that franchise, our growth and in particular, a focus on Europe. And you can register for that through Amarin's corporate website. And beyond that, thanks again for joining us. Have a good evening. Bye now.

是的。謝謝你，約翰。首先，感謝大家今晚參加我們的活動。我們對此表示感謝。提醒一下，11 月 14 日，我們將舉辦一場虛擬分析師和投資者活動。我們要做的是專注於 VASCEPA 和 VAZKEPA 特許經營權，專注於代表該特許經營權未來的一些關鍵地區的動態、我們的成長，尤其是歐洲。您可以透過 Amarin 的公司網站進行註冊。除此之外，再次感謝您的加入我們。祝你晚上愉快。再見了。

This concludes today's conference and you may disconnect your lines at this time. Thank you for your participation.

今天的會議到此結束，各位現在可以掛斷電話了。感謝您的參與。