Amarin Corporation PLC (AMRN) 2024 Q2 法說會逐字稿

Welcome to Amarin Corporation's conference call to discuss its second quarter 2024 business update and financial results. I would now 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 年第二季業務更新和財務業績。我現在想將電話會議轉給 Amarin 企業傳播和投資者關係副總裁 Mark Marmur。

Good morning, everyone, and thank you for joining us. Turning to 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.

大家早安，感謝您加入我們。轉向我們的前瞻性陳述。請注意，本次電話會議將包含前瞻性聲明，這些聲明旨在涵蓋聯邦證券法規定的安全港。我們可能無法實現我們的目標，執行我們的計劃或意圖，或達到我們前瞻性陳述中所揭露的期望。

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.

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。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不反映我們可能簽訂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簽訂、修改或終止的重大協議。

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 June 30, 2024, which has been filed with the SEC and is available through the Investor Relations section of our website at www.amarincorp.com.

有關可能導致實際結果出現重大差異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10-K 表格中的風險因素部分，以及我們截至2023 年12 月31 日的表格10-Q 季度報告中的風險因素部分。

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 overview of his perspectives Amarin's value and second quarter business progress; and Tom Reilly, Amarin's Chief Financial Officer, will provide a review of our second quarter 2024 financial results. At the end of the presentation, there will be the chance to ask questions.

我們鼓勵每個人閱讀這些文件。本次電話會議的存檔將發佈在 Amarin 網站的投資者關係部分。談到今天的議程，Amarin 總裁兼執行長 Aaron Berg 將概述他對 Amarin 價值和第二季度業務進展的看法； Amarin 財務長 Tom Reilly 將回顧我們 2024 年第二季的財務表現。演講結束時，將有機會提問。

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

我現在將把電話轉給 Amarin 總裁兼執行長 Aaron Berg。亞倫？

Thank you, Mark. Good morning, everyone, and thank you for joining us today. I'm thrilled to be back leading Amarin in a very short time. As Interim CEO last year, I was able to spearhead several key global strategic and organizational adjustments.

謝謝你，馬克。大家早安，感謝您今天加入我們。我很高興能在很短的時間內重新領導阿瑪林。去年，作為臨時首席執行官，我領導了幾項關鍵的全球策略和組織調整。

Now, back in the CEO role for just a few short weeks, it's gratifying to see some of the impact of those changes. I've been with Amarin for over a decade and remain as passionate and committed to the company as when I started for several very important reasons.

現在，我重新擔任執行長僅幾週，很高興看到這些變化所產生的一些影響。我在 Amarin 工作了十多年，由於幾個非常重要的原因，我仍然像剛開始時一樣對公司充滿熱情和忠誠。

First of all, VASCEPA/VAZKEPA is an incredible product. Over the last 10 years, more than 300 scientific publications have been generated, confirming the unique attributes of VASCEPA anchored by the landmark REDUCE-IT trial.

首先，VASCEPA/VAZKEPA 是一款令人難以置信的產品。在過去 10 年裡，已經發表了 300 多篇科學出版物，證實了以具有里程碑意義的 REDUCE-IT 試驗為基礎的 VASCEPA 的獨特屬性。

Confirming that VASCEPA provides an important option for patients globally who need to reduce their risk of a cardiovascular event. I ran the US commercial organization when the REDUCE-IT trial read out and when we subsequently secured the cardiovascular risk reduction indication. The reception of this remarkable data by the scientific community and the potential to positively impact millions of patients with VASCEPA generated incredible demand.

確認 VASCEPA 為全球需要降低心血管事件風險的患者提供了一個重要的選擇。當 REDUCE-IT 試驗結果公佈以及我們隨後獲得心血管風險降低指標時，我負責管理美國商業組織。科學界對這一非凡數據的接受以及對數百萬 VASCEPA 患者產生積極影響的潛力產生了令人難以置信的需求。

Prescriptions increased significantly and product revenue rose substantially. We witnessed a greater than 50% increase in the number of prescribers resulting in more than 80% growth in new prescriptions in the first year post publication of REDUCE-IT.

處方大幅成長，產品收入大幅成長。我們見證了 REDUCE-IT 出版後第一年，處方醫生數量增加了 50% 以上，導致新處方數量增加了 80% 以上。

This evidence of uptake and market response provides evidence that with time to promote and educate supported by outstanding execution, providers respond favorably to VASCEPA as a therapy that can benefit their patients. Second, even with many advancements in therapies and scientific data, cardiovascular disease remains the number one killer globally, causing a significant financial burden and negatively impacting patients and their families.

這種採用和市場反應的證據表明，隨著時間的推廣和教育以及出色的執行力的支持，提供者會對 VASCEPA 作為一種可以使患者受益的療法做出積極的反應。其次，儘管治療方法和科學數據取得了許多進步，心血管疾病仍然是全球第一大殺手，造成了巨大的經濟負擔，並對患者及其家人產生了負面影響。

Additionally, millions of prescriptions are written globally each year for fibrates and omega-3 mixture products for patients with cardiovascular risk, even though they're not beneficial in reducing cardiovascular risk.

此外，全球每年都會為有心血管風險的患者開出數百萬張貝特類藥物和 omega-3 混合物產品處方，儘管它們無助於降低心血管風險。

As a result, the reduction of cardiovascular events remains a top priority for healthcare providers, patients, caretakers, governments and the investment community. Our confidence remains steadfast that VASCEPA/VAZKEPA represents an important option in the global arsenal against cardiovascular disease, and therefore a true difference maker in patients' lives.

因此，減少心血管事件仍然是醫療保健提供者、患者、護理人員、政府和投資界的首要任務。我們堅信 VASCEPA/VAZKEPA 是全球對抗心血管疾病的重要選擇，因此能夠真正改變患者的生活。

Third, unlike in the US, where we had time to commercialize VASCEPA prior to the publication of the REDUCE-IT data and the cardiovascular risk reduction indication, we're in the early phases of our global expansion effort, targeting key markets around the world.

第三，與美國不同，在美國，我們有時間在 REDUCE-IT 數據和心血管風險降低指標發布之前將 VASCEPA 商業化，而我們正處於全球擴張努力的早期階段，目標是全球主要市場。

To date, we've unlocked access and launched in some European markets. However, there remains significant potential to advance access to VASCEPA for many at risk patients in a number of additional critical markets. And finally, VAZKEPA has a long runway to generate revenue based on its strong IP position, particularly in Europe, where we have recently received extended patent rights into 2039.

到目前為止，我們已經解鎖了訪問權限並在一些歐洲市場推出。然而，在許多其他關鍵市場中，為許多高風險患者提供 VASCEPA 的機會仍然存在巨大潛力。最後，VAZKEPA 憑藉其強大的智慧財產權地位，有很長的路要走才能創造收入，特別是在歐洲，我們最近在歐洲獲得了將專利權延長至 2039 年的權利。

The combination of the strength and extent of clinical data, its runway and the opportunity for sustained growth and impact, together with the ability to save lives around the world, translate into a tremendous opportunity for us to maximize VASCEPA/VAZKEPA's worldwide potential.

臨床數據的強度和範圍、其跑道、持續增長和影響的機會以及拯救世界各地生命的能力相結合，為我們最大限度地發揮 VASCEPA/VAZKEPA 的全球潛力帶來了巨大的機會。

Before we move on to operational performance in the second quarter, there are a few additional points I want to highlight about Amarin and how we'll operate moving forward under my leadership. We have a fantastic team, smart, committed, passionate, and I can assure you that no one here is satisfied with our commercial progress. We're always looking for ways that we can generate new ideas and improve execution, and we know we must find new ways to perform better and faster.

在我們討論第二季的營運表現之前，我想強調一些關於阿瑪林的額外觀點，以及我們將如何在我的領導下繼續運作。我們擁有一支出色的團隊，聰明、忠誠、熱情，我可以向您保證，這裡沒有人對我們的商業進展感到滿意。我們一直在尋找能夠產生新想法和提高執行力的方法，我們知道我們必須找到新方法來更好更快地執行。

As a significant shareholder with substantial vested interest in the company's success, I'm determined to drive value for all of us and understand my responsibility to do just that. As I lead the company to build greater value, I think and act like a shareholder every day. My focus is clear to prioritize execution and performance while urgently evaluating opportunities to expand the impact of VASCEPA to millions of patients worldwide. That's our commitment to provide value to patients, providers, payers and of course, shareholders.

作為一個對公司成功擁有重大既得利益的重要股東，我決心為我們所有人創造價值，並理解我有責任做到這一點。當我帶領公司創造更大價值時，我每天都像股東一樣思考和行事。我的重點很明確，就是優先考慮執行和績效，同時緊急評估將 VASCEPA 的影響力擴大到全球數百萬名患者的機會。這是我們為患者、提供者、付款人，當然還有股東提供價值的承諾。

Let me now turn to some of the operational highlights from the quarter. Turning to slide 6, in Europe, our teams are making progress in realizing incremental revenue growth, but we have much more work ahead of us. The seeds for recent growth were planted more than a year ago when we put a new strategy in place centered around targeting a more focused patient population, coupled with improved resource prioritization, all with a focus on enhancing the value proposition for VAZKEPA in the market that can deliver the greatest impact for patients. Part of the challenge we faced in Europe is the reality that compelling data such as, REDUCE-IT, many times clashes with budget realities in individual markets.

現在讓我談談本季的一些營運亮點。轉向幻燈片 6，在歐洲，我們的團隊在實現增量收入成長方面正在取得進展，但我們還有更多的工作要做。近期成長的種子是在一年多前播下的，當時我們制定了一項新策略，以更集中的患者群體為中心，再加上改進的資源優先級，所有這些都專注於增強VAZKEPA 在市場上的價值主張，可以為患者帶來最大的影響。我們在歐洲面臨的部分挑戰是這樣一個現實：REDUCE-IT 等令人信服的數據多次與各市場的預算現實發生衝突。

A broader label creates an enormous opportunity in Europe due to the strength of the REDUCE-IT trial, which demonstrates that VAZKEPA can benefit millions of patients, all within the label. There are approximately 7 million patients that meet the label criteria in Europe.

由於 REDUCE-IT 試驗的優勢，更廣泛的標籤在歐洲創造了巨大的機會，這表明 VAZKEPA 可以使數百萬患者受益，所有這些都在標籤內。歐洲約有 700 萬名患者符合標籤標準。

While this is very powerful and the scale is an enormous opportunity for us, it's also a challenge for the reimbursement authorities from a budget perspective. We need to respect that and work with the authorities to find the middle ground of helping as many patients as possible, while doing so in a manner that's sensitive to the budget constraints.

雖然這是非常強大的，而且規模對我們來說是一個巨大的機會，但從預算的角度來看，這對報銷當局來說也是一個挑戰。我們需要尊重這一點，並與當局合作，找到幫助盡可能多的患者的中間立場，同時以對預算限制敏感的方式這樣做。

In 2023, we implemented a strategy to accelerate progress, which focuses on a higher risk subset of REDUCE-IT patients. This is intended to help us obtain favorable access and reimbursement more quickly, while preserving long-term potential, as well as accelerate sales growth upon launch with a more focused, efficient commercial structure. We're seeing this strategy resonate with authorities and hope that once we establish momentum in key country providers, they will use the product to benefit more of their at-risk patients. In the second quarter, the team continued to deliver on this strategy and made advances.

2023 年，我們實施了一項加速進展的策略，重點關注 REDUCE-IT 患者中風險較高的子集。此舉旨在幫助我們更快獲得有利的准入和報銷，同時保留長期潛力，並透過更專注、高效的商業結構加速產品推出後的銷售成長。我們看到這項策略引起了當局的共鳴，並希望一旦我們在主要國家的供應商中建立起勢頭，他們將使用該產品使更多的高風險患者受益。第二季度，團隊持續落實這項策略並取得進展。

Specifically, Spain is delivering robust growth following our highly successful VAZKEPA launch in that country last fall. The early success in Spain further confirms what we learned from our promotional and educational efforts in the US, that when HCPs and payers learn about the science and benefits of VAZKEPA, this medication can sell in Europe.

具體來說，去年秋天我們在西班牙推出 VAZKEPA 取得了巨大成功，該國正在實現強勁成長。西班牙的早期成功進一步證實了我們從美國的宣傳和教育工作中學到的知識，即當 HCP 和付款人了解 VAZKEPA 的科學性和益處時，這種藥物可以在歐洲銷售。

Our sales team there is targeting 2,500 key HCPs covering 80% of the total market and augmenting our sales efforts with continued focus on a commercial and medical strategy centered on increased HCP interactions, regional congresses and publication plans.

我們的銷售團隊的目標是 2,500 名關鍵 HCP，覆蓋整個市場的 80%，並透過繼續專注以增加 HCP 互動、區域會議和出版計劃為中心的商業和醫療策略來加強我們的銷售力度。

These efforts should help to solidify the case for VAZKEPA in this important European market and should serve as a model for how we expect to execute our strategy in other European markets. In the UK, we implemented significant impactful changes to accelerate growth.

這些努力應該有助於鞏固 VAZKEPA 在這個重要的歐洲市場的地位，並且應該成為我們如何在其他歐洲市場執行我們的策略的典範。在英國，我們實施了重大且有影響力的變革來加速成長。

Our refined, focused commercial strategy, coupled with organizational changes including a new General Manager and a revamped sales force structure. The UK team is energized, focused and accelerating growth. They're focused on the most critical accounts and optimizing access to these accounts.

我們完善、專注的商業策略，加上組織變革，包括新任總經理和改進的銷售團隊結構。英國團隊充滿活力、專注並加速成長。他們專注於最關鍵的帳戶並優化對這些帳戶的存取。

We expect this positive momentum to continue and contribute to sustained incremental revenue growth as we move forward. Turning to pricing and reimbursement progress, we're focused on advancing opportunities in other key EU5 markets. In Italy, our dossier is now under review with local health authorities. We are confident that our submission will again deliver a positive clinical assessment and we remain committed to doing all we can with the authorities to lead to a successful price negotiation by the end of the year.

我們預計這種積極勢頭將持續下去，並在我們前進的過程中為持續的增量收入成長做出貢獻。談到定價和報銷進展，我們專注於推進其他主要歐盟五國市場的機會。在義大利，我們的檔案目前正在接受當地衛生當局的審查。我們相信，我們提交的文件將再次提供積極的臨床評估，我們仍然致力於與當局竭盡全力，以便在年底前成功進行價格談判。

In France, with the recent publication of the RESPECT-EPA cardiovascular outcome study of icosapent ethyl, we have key additional data available which will strengthen our clinical dossier. In other European markets we recently secured national pricing and reimbursement in Greece and Portugal, and we look forward to realizing additional revenue contributions from these markets.

在法國，隨著最近發表的二十碳五烯酸乙酯 RESPECT-EPA 心血管結果研究，我們獲得了關鍵的額外數據，這將加強我們的臨床檔案。在其他歐洲市場，我們最近在希臘和葡萄牙獲得了國家定價和報銷，我們期待從這些市場實現額外的收入貢獻。

As we look to the future, the European market represents an important long-term source of growth for VAZKEPA. With IP protection in Europe out to 2039, we stand to realize tremendous value and impact millions of patients for years to come.

展望未來，歐洲市場是 VAZKEPA 重要的長期成長來源。隨著歐洲的智慧財產權保護到 2039 年，我們將在未來幾年實現巨大的價值並影響數百萬名患者。

Moving to slide 7 in the rest of the world. Overall, the rest of the world represents a number of countries that together provide a sizable market expansion opportunity. Along with our partners, we continue to make regulatory market access and commercial launch progress across key markets, all of which further expands access for patients to VASCEPA/VAZKEPA, reinforces the impact the product has already achieved and enhances cash generation for the future.

轉到世界其他地區的幻燈片 7。總體而言，世界其他地區代表了許多國家，這些國家共同提供了相當大的市場擴張機會。我們與我們的合作夥伴一起，繼續在關鍵市場取得監管市場准入和商業上市進展，所有這些都進一步擴大了患者使用VASCEPA/VAZKEPA 的機會，增強了產品已經取得的影響，並增強了未來的現金生成。

Specifically looking at Asia, in China, our partner Eddingpharm recently announced that they received regulatory approval for VASCEPA for cardiovascular risk reduction from China's National Medical Products Administration, or NMPA.

特別是在亞洲，在中國，我們的合作夥伴 Eddingpharm 最近宣布，他們的 VASCEPA 用於降低心血管風險的藥物已獲得中國國家藥品監督管理局 (NMPA) 的監管批准。

Following approval by NMPA, Edding is working to include VASCEPA on the National Reimbursement Drug List, or NRDL, and augment the ongoing commercial launch of VASCEPA in China to include the cardiovascular risk reduction indication.

在獲得 NMPA 批准後，Edding 正在努力將 VASCEPA 納入國家醫療保健藥物目錄 (NRDL)，並擴大 VASCEPA 在中國正在進行的商業上市，將降低心血管風險的適應症納入其中。

NRDL listing serves as the primary pathway for public reimbursement of pharmaceutical products in China, covering 98% of the Chinese population. Products included in this listing can be readily prescribed from public hospitals in China. This is an important step in advancing access for VASCEPA to patients across China and to making it a key component in the treatment paradigm addressing the growing CBD public health issue in the second most populated country in the world.

國家健保目錄是中國藥品公共報銷的主要途徑，涵蓋了98%的中國人口。此清單中包含的產品可以輕鬆地從中國的公立醫院開處方。這是推動 VASCEPA 為中國各地患者提供服務的重要一步，並使其成為解決世界第二人口大國日益嚴重的 CBD 公共衛生問題的治療模式的關鍵組成部分。

To that point, according to the World Heart Federation, cardiovascular events such as ischemic heart disease and stroke have been projected to increase by 50% among the population in China between 2010 and 2030. As a reminder, our agreement states that as a result of achieving the cardiovascular risk reduction indication in China, Amarin earned a $15 million milestone payment from Edding, in addition to future commercial milestone payments, as well as tiered royalties on sales, a source of sustained cash in the years to come.

根據世界心臟聯合會預測，2010年至2030年間，中國人口的缺血性心臟病和中風等心血管事件預計將增加50%。提醒一下，我們的協議規定，由於在中國實現了心血管風險降低指標，Amarin 從 Edding 獲得了 1500 萬美元的里程碑付款，此外還有未來的商業里程碑付款以及分級銷售特許權使用費，這是未來幾年持續現金。

In Australia, our partner CSL Seqirus has now advanced the pricing and reimbursement discussions with local authorities to the final stages. We're also supporting commercial launch readiness in the market through medical education and sales force readiness initiatives.

在澳大利亞，我們的合作夥伴 CSL Seqirus 現已與地方當局的定價和報銷討論推進到最後階段。我們還透過醫學教育和銷售人員準備計劃來支援市場上的商業發布準備。

In Canada, our partner, HLS Therapeutics announced that its entered into a product listing agreement with the Province of Alberta for the listing and public reimbursement of VASCEPA. The PLA with Alberta Health is effective August 1, 2024.

在加拿大，我們的合作夥伴 HLS Therapeutics 宣布與阿爾伯塔省就 VASCEPA 的上市和公共報銷簽訂了產品上市協議。PLA 與阿爾伯塔省衛生局於 2024 年 8 月 1 日生效。

In summary, our teams and partners are continuing to advance efforts to get VASCEPA and VAZKEPA into the hands of as many patients as possible globally. We've made progress under sometimes difficult market and reimbursement challenges, but as more stakeholders become increasingly educated on the strength of the VASCEPA clinical data and what it means for patient care, our confidence continues to solidify on its long-term value.

總之，我們的團隊和合作夥伴正在繼續努力，將 VASCEPA 和 VAZKEPA 送到全球盡可能多的患者手中。我們在有時困難的市場和報銷挑戰中取得了進展，但隨著越來越多的利益相關者越來越多地了解VASCEPA 臨床數據的優勢及其對患者護理的意義，我們對其長期價值的信心繼續增強。

Now, turning to slide 8 in the US. In the second quarter, the US team continued to maintain our IPE market leadership through exclusive accounts representing approximately 50% of the IPE market. Prescription market share remained stable in the US for the seven consecutive quarter, while revenues in the quarter were impacted primarily by a decline in net selling price due to generic competition. The US business continues to generate cash, funding our efforts globally, particularly in Europe.

現在，轉向美國的幻燈片 8。第二季度，美國團隊透過佔 IPE 市場約 50% 的獨家帳戶繼續保持我們的 IPE 市場領先地位。美國處方藥市佔率連續七季保持穩定，而該季度的收入主要受到仿製藥競爭導致淨售價下降的影響。美國業務繼續產生現金，為我們在全球（尤其是歐洲）的努力提供資金。

Our market share strength is a direct result of what the US team has done to work efficiently while maximizing VASCEPA's value in the US, despite last year's strategic decision to eliminate the sales force and significantly reduce marketing spend given increasing generic competition. While we're encouraged that the prescription volume has remained stable in the first half of 2024, as we've always said, the US market is highly dynamic.

我們的市場佔有率優勢是美國團隊在最大化 VASCEPA 在美國價值的同時高效工作的直接結果，儘管去年由於仿製藥競爭日益激烈而做出了消除銷售人員並大幅減少行銷支出的戰略決策。正如我們一直所說的那樣，儘管我們對 2024 年上半年處方量保持穩定感到鼓舞，但美國市場充滿活力。

We announced during the second quarter that in the second half of 2024, our business will be impacted by the loss of an important contract with a major exclusive commercial account which moved branded VASCEPA to a blocked status on its formulary.

我們在第二季度宣布，到 2024 年下半年，我們的業務將受到與一個主要獨家商業帳戶簽訂的一份重要合約的損失的影響，該合約使 VASCEPA 品牌在其處方集上處於封鎖狀態。

This account represents approximately 25% of our business and is expected to reduce our second half 2024 revenues. It is important to keep in mind that while the decision will undoubtedly have a significant impact on overall VASCEPA volume, we believe that branded VASCEPA will continue to be the market leader in the total IPE market even after taking into account the full impact of the loss of this major exclusive plan is absorbed.

該帳戶約占我們業務的 25%，預計將減少我們 2024 年下半年的收入。重要的是要記住，雖然該決定無疑會對 VASCEPA 整體銷售產生重大影響，但我們相信，即使考慮到損失的全面影響，品牌 VASCEPA 將繼續成為整個 IPE 市場的市場領導者這項重大獨家計劃被吸收。

And importantly, despite the ongoing challenges presented by generic competition in the US, remember, we've prepared for all scenarios and are ready to change our approach to this business as the market continues to evolve. This includes the launch of an authorized generic at the optimal time, which will be bolstered by our strong supply position. We believe this would help us retain our IPE market leadership, as well as generate revenue for years to come.

重要的是，儘管美國仿製藥競爭帶來了持續的挑戰，但請記住，我們已經為所有情況做好了準備，並準備好隨著市場的不斷發展而改變我們的業務方法。這包括在最佳時間推出授權仿製藥，這將得到我們強大的供應地位的支持。我們相信，這將有助於我們保持 IPE 市場的領先地位，並在未來幾年創造收入。

Now, I'd like to hand the call over to Tom Reilly to review our second quarter 2024 financial performance. Tom?

現在，我想將電話轉交給 Tom Reilly，回顧我們 2024 年第二季的財務表現。湯姆？

Thank you, Aaron. Good morning, everyone. Today, I'm reporting details regarding our financial performance in the second-quarter of 2024. Turning to slide 10 in the second quarter of 2024, Amarin reported total net revenue of $67.5 million, which included net product revenue of $47.5 million and $20 million of licensing and royalty revenue versus $80.2 million total revenue in the second quarter of 2023.

謝謝你，亞倫。大家早安。今天，我將詳細報告 2024 年第二季的財務表現。轉向幻燈片10，Amarin 報告2024 年第二季度的總淨收入為6750 萬美元，其中包括4750 萬美元的產品淨收入以及2000 萬美元的許可和特許權使用費收入，而2023 年第二季度的總收入為8,020 萬美元。

US product revenue was $43.8 million in the second quarter of 2024 versus $64.6 million in the second quarter of 2023. This decline was driven largely by lower net selling price due to the generic competition in the market. Despite the revenue decline, the US business continues to deliver significant cash.

2024 年第二季美國產品營收為 4,380 萬美元，而 2023 年第二季為 6,460 萬美元。這一下降主要是由於市場仿製藥競爭導致淨售價下降所致。儘管收入下降，美國業務仍繼續提供大量現金。

Product revenue also reflects European net product revenue of $3.5 million, a $2.9 million increase over the prior year, driven by revenue growth from both Spain and the UK, as well as supply shipments to our partners in Greece and Israel.

產品收入也反映了歐洲產品淨收入 350 萬美元，比前一年增加了 290 萬美元，這得益於西班牙和英國的收入增長以及向希臘和以色列合作夥伴的供應發貨。

Licensing and royalty revenue was $20 million in the second quarter of 2024 versus $15 million in the second quarter of 2023. The current quarter amount reflects the contribution of a $15 million milestone related to obtaining cardiovascular risk reduction approval in China and a $4 million of non-cash payment related to change in accounting estimate on a previously received partnership milestone.

2024 年第二季的授權和特許權使用費收入為 2,000 萬美元，而 2023 年第二季為 1,500 萬美元。本季度金額反映了與獲得中國心血管風險降低批准相關的 1500 萬美元里程碑的貢獻，以及與先前獲得的合作夥伴里程碑的會計估計變更相關的 400 萬美元非現金付款。

Cost of goods sold in the second quarter of 2024 was $24.7 million, compared to $37.5 million in the second quarter of 2023. Gross margin in the second quarter of 2024 was 48% and Q2 2023 was 64%, excluding inventory restructuring charges in the second quarter of 2023. This decline is due to a decline in the net selling price in the US.

2024 年第二季的銷售成本為 2,470 萬美元，而 2023 年第二季為 3,750 萬美元。2024年第二季的毛利率為48%，2023年第二季的毛利率為64%，不包括2023年第二季的庫存重組費用。這一下降是由於美國淨售價下降所致。

Now, moving on to operating expense of the P&L. July 2023, we announced we would reduce our cost basis by $40 million annually. Today, we are pleased to report that we have achieved $50 million in cost savings on an annualized basis.

現在，轉向損益表的營運費用。2023 年 7 月，我們宣布每年將成本基礎減少 4,000 萬美元。今天，我們很高興地報告，我們每年節省了 5000 萬美元的成本。

Overall, operating expenses were $43.3 million in the second quarter, comprised of $38.5 million in selling, general and administrative expenses and $4.7 million in research and development expenses, which is approximately a $14 million reduction in operating expenses versus the second quarter 2023, excluding the 2023 restructuring expenses.

整體而言，第二季營運費用為4,330 萬美元，其中包括3,850 萬美元的銷售、一般和管理費用以及470 萬美元的研發費用，與2023 年第二季相比，營運費用減少了約1,400 萬美元，不含2023年重組費用。

Turning to profitability. We reported a GAAP net income of $1.5 million for the second quarter of 2024 versus a $17.6 million loss in the prior year period. On an adjusted basis, the company realized a profit of $5.9 million versus $8.6 million in 2023.

轉向盈利能力。我們公佈的 2024 年第二季 GAAP 淨利潤為 150 萬美元，而去年同期虧損 1,760 萬美元。調整後，該公司實現利潤 590 萬美元，而 2023 年為 860 萬美元。

Now, let me turn to slide 11 and our efforts and results in controlling costs and effectively managing our cash. As of June 30, 2024, Amarin reported aggregate cash and investments of $307 million. While our cash balance has been impacted by revenue shortfall, we have successfully maintained a stable cash position over the last eight quarters. The sizable cash balance provides an important foundation for the company. We continue to focus on balancing, preserving cash with managing costs and at the same time pursuing channels to expand product revenue.

現在，讓我轉向投影片 11，以及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 6 月 30 日，Amarin 報告的現金和投資總額為 3.07 億美元。儘管我們的現金餘額受到收入短缺的影響，但我們在過去八個季度成功保持了穩定的現金狀況。龐大的現金餘額為公司提供了重要的基礎。我們持續專注於平衡、保留現金與管理成本，同時尋求擴大產品收入的管道。

Now, let me provide a brief update on our share repurchase program. As announced in January, Amarin entered into a conditional share repurchase agreement with Cantor Fitzgerald to purchase up to $50 million of Amarin's ordinary shares. The company announced this program given its confidence in the business and our cash position at that time and the potential to return value to shareholders.

現在，讓我簡要介紹一下我們的股票回購計劃。正如一月份宣布的那樣，Amarin 與 Cantor Fitzgerald 簽訂了有條件股票回購協議，購買最多 5000 萬美元的 Amarin 普通股。鑑於公司對業務和當時的現金狀況以及為股東回報價值的潛力的信心，公司宣布了這項計劃。

In April, we secured shareholder approval and in May, we successfully secured UK High Court approval for the share repurchase program. While we actively assess business and market conditions on an ongoing basis, including the performance of our business, our cash position and other factors, at this time, we have not initiated share repurchases given current conditions. We will continue to assess these conditions moving forward and we would consider initiating share repurchases if and when the business and market conditions improve.

4 月份，我們獲得了股東批准，5 月份，我們成功獲得了英國高等法院對股票回購計畫的批准。雖然我們持續積極評估業務和市場狀況，包括我們的業務表現、現金狀況和其他因素，但鑑於目前的情況，我們尚未啟動股票回購。我們將繼續評估這些條件，如果業務和市場狀況改善，我們將考慮啟動股票回購。

With that, I will now turn back to Aaron for closing remarks and to begin the Q&A portion of our call. Aaron?

現在，我將回到亞倫進行結束語，並開始我們電話會議的問答部分。亞倫？

Thanks, Tom, for the overview of financial results and the update on the share repurchase program. As we shared this morning, we believe there's significant long-term value in VASCEPA/VAZKEPA. Our goal is simple and clear to harness the attributes of the product over 10 years of science and clinical data, including more than 300 publications on VASCEPA and the backing of 30 medical societies around the world recognizing the value of the product and extended IP position in Europe out to 2039 and unmet need globally to reduce cardiovascular risk as cardiovascular disease remains the number one killer around the world, and multiple key untapped markets in Europe and the rest of the world where access can be opened to maximize its value potential at a faster pace.

感謝湯姆提供財務業績概述和股票回購計畫的最新資訊。正如我們今天早上分享的那樣，我們相信 VASCEPA/VAZKEPA 具有重大的長期價值。我們的目標簡單明了，即利用 10 多年科學和臨床數據的產品屬性，包括 VASCEPA 上的 300 多篇出版物以及全球 30 個醫學協會的支持，認可該產品的價值並擴大了知識產權地位歐洲到2039年，全球降低心血管風險的需求未被滿足，因為心血管疾病仍然是全球頭號殺手，歐洲和世界其他地區有多個未開發的關鍵市場，可以更快地開放准入，最大限度地發揮其價值潛力步伐。

The progress we've made to date is not enough. We understand the need to accelerate performance, to realize the potential of the product across Europe and the rest of the world markets with our partners, and to continue to maximize profitability in the US. As we continue our operational execution to rapidly build value across global markets. We're also examining all possibilities and opportunities to unlock the value of this product for more patients.

迄今為止我們取得的進展還不夠。我們了解需要提高性能，與我們的合作夥伴一起實現歐洲和世界其他市場的產品潛力，並繼續最大限度地提高美國的獲利能力。隨著我們繼續執行運營，在全球市場上快速創造價值。我們也正在研究為更多患者釋放該產品價值的所有可能性和機會。

Before we turn to Q&A, I'd like to thank our Amarin colleagues for their continued commitment and dedication. Each of you come to work every day focused on bringing VASCEPA and VAZKEPA to patients, because you know it can make a difference. Thank you all for your efforts. And with that, Mark, let's begin the Q&A portion of the call.

在我們進行問答之前，我要感謝我們的 Amarin 同事的持續承諾和奉獻精神。你們每個人每天上班都專注於將 VASCEPA 和 VAZKEPA 帶給患者，因為你們知道它可以帶來改變。感謝大家的努力。馬克，接下來讓我們開始電話的問答部分。

Thank you, Aaron. As we previously shared, to enhance engagement with the company's shareholder base and facilitate connections with its investors, Amarin has partnered with say technologies to allow retail and institutional shareholders to submit and upvote questions, a selection of which will be answered by Amarin management during today's earnings call. Let's begin the Q&A. Aaron, this question is for you.

謝謝你，亞倫。正如我們之前分享的，為了加強與公司股東基礎的互動並促進與投資者的聯繫，Amarin 與say Technologies 合作，允許散戶和機構股東提交和投票問題，Amarin 管理層將在今天的會議上回答其中的一些問題財報電話會議。讓我們開始問答。亞倫，這個問題是問你的。

In the US, what is our outlook for continued stabilization in VASCEPA US revenues against additional generic competition? And what's the plan for renewing exclusive contracts for 2025?

在美國，面對額外的仿製藥競爭，我們對 VASCEPA 美國收入持續穩定的前景有何看法？2025年獨家續約的計畫是什麼？

Thanks, Mark. And first of all, thanks again to all the investors who submitted these questions. We greatly appreciate it.

謝謝，馬克。首先，再次感謝所有提出這些問題的投資者。我們非常感激。

It's important to keep in mind that while the loss of the commercial exclusive in the US is certainly significant, we believe that branded VASCEPA will continue to be the market leader after the full impact of the loss of the major exclusive plans absorbed. This recent decision only impacts that single commercial plan under that account. It does not impact Medicare Part D plans.

重要的是要記住，雖然美國商業獨家計劃的損失肯定很大，但我們相信，在吸收主要獨家計劃損失的全面影響後，品牌 VASCEPA 將繼續成為市場領導者。最近的這項決定僅影響該帳戶下的單一商業計劃。它不會影響 Medicare D 部分計劃。

The significant majority of our exclusive volume is in Medicare Part D plans. We do have exclusive IPE status at other commercial plans, but those plans represent a smaller portion of our total volume. Based on the feedback we received from the PBM for those plans, we expect that they will retain exclusive status for the remainder of 2024. Looking at 2025, we submitted what we believe to be competitive offers for 2025, and plans are now in the process of making their decisions regarding formulary coverage to start 2025.

我們獨家銷售量的絕大部分來自 Medicare D 部分計劃。我們確實在其他商業計劃中擁有獨家 IPE 地位，但這些計劃只占我們總量的一小部分。根據我們從 PBM 收到的有關這些計劃的反饋，我們預計它們將在 2024 年剩餘時間內保持獨家地位。展望 2025 年，我們提交了我們認為具有競爭力的 2025 年報價，各計劃目前正在就 2025 年開始的處方覆蓋範圍做出決定。

The feedback we've received to-date regarding our offers has been positive, but it's far too early to make any predictions regarding 2025 coverage status even at the plans that have given us positive feedback. We also have been preparing and have the ability to launch an authorized generic, if necessary, to maintain our leadership position.

到目前為止，我們收到的有關我們的優惠的反饋都是積極的，但即使對於給我們提供了積極反饋的計劃，現在對 2025 年的承保狀況做出任何預測還為時過早。我們也一直在準備並有能力在必要時推出授權仿製藥，以維持我們的領導地位。

Thanks, Aaron. Tom, during today's call, we provided an update regarding the share repurchase program. Can you share more on the market conditions impacting the decision not to commence share repurchases?

謝謝，亞倫。湯姆，在今天的電話會議中，我們提供了有關股票回購計劃的最新資訊。您能否分享更多有關影響不開始股票回購決定的市場狀況的資訊？

Thank you for the question. While we received both shareholder and UK high court approvals in the second quarter, we did not commence any share repurchases in the second quarter due to business and market conditions. We are monitoring the cash generation in the US business over the coming quarters, following the loss of a key commercial exclusive plan, as well as our progress in Europe. As these factors impact our cash position, and the viability of the share repurchase program moving forward.

謝謝你的提問。雖然我們在第二季獲得了股東和英國高等法院的批准，但由於業務和市場狀況，我們沒有在第二季開始任何股票回購。在失去一項關鍵的商業獨家計劃後，我們正在監控未來幾季美國業務的現金產生情況，以及我們在歐洲的進展。由於這些因素影響我們的現金狀況以及股票回購計畫的可行性。

Thanks, Tom. Investors would also like to know if we have an update on a potential delisting from NASDAQ and if we would consider a reverse split to increase the share price.

謝謝，湯姆。投資人也想知道我們是否有可能從納斯達克退市的最新消息，以及我們是否會考慮反向分拆以提高股價。

Thanks, Mark. First, on the delisting, given that we traded under $1 for 30 consecutive trading days, we received official notice of a potential delisting from NASDAQ at the end of May. Keep in mind, the full process could take up to 360 days, if we continue to trade below $1.

謝謝，馬克。首先，關於退市，鑑於我們連續30個交易日的交易價格低於1美元，我們在5月底收到了納斯達克可能退市的正式通知。請記住，如果我們繼續以低於 1 美元的價格進行交易，整個過程可能需要長達 360 天。

However, there are financial levers, strategic and operational opportunities to regain compliance. We believe the operational opportunities are to progress in Europe, advancing efforts with partners in the rest of the world, and delivering cash in the US, which all can help us to regain NASDAQ compliance. On a potential reverse stock split, we are always considering the pros and cons of all options to increase shareholder value.

然而，存在著恢復合規性的財務槓桿、策略和營運機會。我們認為，營運機會是在歐洲取得進展，與世界其他地區的合作夥伴共同推進，以及在美國交付現金，這些都可以幫助我們重新獲得納斯達克合規性。對於潛在的反向股票分割，我們始終在考慮增加股東價值的所有選擇的優缺點。

Jonathan, we've received a number of questions regarding the recent decision by the Federal Circuit to reverse a previous decision in the skinny label litigation. Can you comment on that?

喬納森，我們收到了一些關於聯邦巡迴法院最近決定推翻瘦標籤訴訟先前決定的問題。你能對此發表評論嗎？

Sure, Mark. To recap, in November 2020, we filed a patent infringement lawsuit against Hikma, alleging that Hikma activities associated with their marketing and sale of their generic icosapent product induced infringement of patents covering the use of VASCEPA to reduce specified CV risk. In January 2022, the district court dismissed our complaint against Hikma for failure to state a claim. We appeal that decision to the appellate court, and the appellate court heard oral arguments in April of 2024.

當然，馬克。回顧一下，2020 年 11 月，我們對 Hikma 提起了專利侵權訴訟，指控 Hikma 與其仿製二十碳五烯酸產品的營銷和銷售相關的活動導致了涉及使用 VASCEPA 降低特定心血管風險的專利侵權。2022 年 1 月，地方法院因 Hikma 未能提出索賠而駁回了我們對 Hikma 的申訴。我們對該決定向上訴法院提出上訴，上訴法院於 2024 年 4 月聽取了口頭辯論。

In late June, the appellate court reversed the district court's decision, finding that our allegations against Hikma do indeed plasma state a claim or induced infringement. Due to this finding, the case will return to the District Court. While we welcome the Federal Circuit's decision, this simply means that the case will now proceed within the District Court. No ruling has yet been made on the merits of the allegations we've made.

6 月下旬，上訴法院推翻了地方法院的裁決，認為我們對 Hikma 的指控確實構成了索賠或誘導侵權。由於這一結論，案件將返回地方法院。雖然我們歡迎聯邦巡迴法院的決定，但這只意味著此案現在將在地方法院審理。目前尚未就我們提出的指控的實質內容做出任何裁決。

Thanks, Jonathan. Steve we recently saw that the respect EPA study was published in circulation. Can you remind our investors about the background of this study and why it is important?

謝謝，喬納森。史蒂夫，我們最近看到環保署的研究報告已發表並廣為流傳。您能否提醒我們的投資者這項研究的背景及其重要性？

Thanks, Mark for the question. The RESPECT-EPA clinical trial is an independent study funded by the Japanese Heart Foundation. In 2005, the Japan EPA Lipid Intervention study or JELIS first demonstrated a beneficial effect of highly purified eicosapentaenoic acid or EPA on cardiovascular outcomes in patients with or without coronary artery disease also referred to a CAD.

謝謝馬克提出的問題。RESPECT-EPA 臨床試驗是一項由日本心臟基金會資助的獨立研究。2005 年，日本EPA 脂質幹預研究(JELIS) 首次證明，高純度二十碳五烯酸(EPA) 對患有或不患有冠狀動脈疾病（也稱為CAD）的患者的心血管結局有益作用。

In 2019, Amarin published the positive results of its double-blind placebo-controlled study REDUCE-IT in patients with cardiovascular risk and elevated TG levels. And now, RESPECT-EPA is the third study that demonstrated the value of highly purified EPA in reducing cardiovascular outcomes in patients with CAD.

2019年，Amarin公佈了其雙盲安慰劑對照研究REDUCE-IT針對有心血管風險和TG水平升高的患者的積極結果。現在，RESPECT-EPA 是第三個證明高純度 EPA 在減少 CAD 患者心血管結局方面價值的研究。

The RESPECT-EPA study used 1.8 grams per day of purified EPA, which is consistent with the substantial body of evidence from the REDUCE-IT and JELIS trials, showing that highly purified prescription EPA plus statin significantly reduces the risk of cardiovascular events in high- and very high-risk statin-treated patients.

RESPECT-EPA 研究每天使用 1.8 克純化 EPA，這與 REDUCE-IT 和 JELIS 試驗的大量證據一致，表明高度純化的處方 EPA 加他汀類藥物可顯著降低高危險群心血管事件的風險。藥物治療的高危險群患者。

Importantly, the study achieved a borderline statistical significance with a 21.5% reduction in the primary composite endpoint measuring cardiovascular risk with the p value of 0.054 and achieved a statistically significant 26.6% reduction in the secondary composite endpoint of RESPECT-EPA with the p value of 0.03. EPA level also matters. A post-hoc analysis conducted by the investigators to control for attained EPA levels yielded a statistically significant 27.5% reduction in the primary endpoint with the p value of 0.02.

重要的是，該研究達到了臨界統計顯著性，測量心血管風險的主要複合終點降低了21.5%，p 值為0.054，RESPECT-EPA 的次要複合終點降低了26.6%，具有統計顯著性，p 值為0.03。 EPA 級別也很重要。研究人員為控制所達到的 EPA 水準而進行的事後分析顯示，主要終點指標顯著降低了 27.5%，p 值為 0.02。

Thank you all for those updates. We will now open the Q&A up for additional questions.

感謝大家的更新。我們現在將針對其他問題開放問答。

(Operator Instructions)

（操作員說明）

Louise Chen, Cantor.

路易絲·陳，康托爾。

Hi. Good morning, everyone. This is Carvey on for Louise from Cantor. Our first question is, with the rise of obesity drugs, has metabolic disease education and marketing been easier with physicians in gaining higher adoption rate for VASCEPA in your target markets?

你好。大家早安。這是卡維為來自康託的路易絲發言。我們的第一個問題是，隨著肥胖藥物的興起，代謝疾病教育和行銷是否變得更容易，醫生可以在目標市場獲得更高的 VASCEPA 採用率？

Second, from a growth perspective, which ex-US markets will be the strongest in driving commercial sales. Thank you.

其次，從成長的角度來看，美國以外的市場將最有力地推動商業銷售。謝謝。

Thank you for the question. We appreciate it. So, first of all, regarding the obesity drugs, can you just clarify your question? It was a little bit muffled. Can you clarify that for us?

謝謝你的提問。我們很感激。那麼，首先，關於減肥藥物，您能澄清一下您的問題嗎？聲音有點低沉。您能為我們澄清一下嗎？

Yes. With obesity drugs, has the conversation with physicians on education and marketing metabolic disease been easier?.

是的。有了肥胖藥物，與醫生就代謝疾病的教育和行銷進行對話是否變得更加容易？

So are you asking, is it making it easier, the GLP-1's. Are you asking, is it making it easier for us to have conversations about VASCEPA and cardiovascular risk reduction?

那麼您是否會問，GLP-1 是否會讓事情變得更容易？您是否在問，這是否讓我們更容易就 VASCEPA 和降低心血管風險進行對話？

Yes, the latter. The conversations with them.

是的，是後者。與他們的對話。

Yes, I think that. So, first of all, that's a very good question, because obviously the obesity drugs are. They are tremendous drugs, and what they've done for patients is tremendous. They've also heightened the awareness of the unmet need and cardiovascular risk reduction.

是的，我是這麼認為的。首先，這是一個非常好的問題，因為肥胖藥物顯然是這樣的。它們是很棒的藥物，為患者帶來了巨大的幫助。他們也提高了人們對未滿足需求和降低心血管風險的認識。

That's exactly where our sweet spot is. There's a lot of overlap with the patients. Even with the obesity drugs, a lot of the patients continue to need cardiovascular risk reduction. Part of the challenge with the noise around the GLP-1s a share of voice issue for us, and that's that we're not a big company like some of those companies that are marketing those drugs.

這正是我們的最佳點。與患者有很多重疊。即使使用了肥胖藥物，許多患者仍需要降低心血管風險。GLP-1 周圍的噪音是我們面臨的部分挑戰，這對我們來說是一個聲音問題，那就是我們不是像某些行銷這些藥物的公司那樣的大公司。

So we have to be very selective on who we speak with, make sure we identify the patients carefully and be very clear about conveying the strength of the VASCEPA clinical data. But it does open the opportunity and increase the opportunity around cardiovascular risk reduction. And there's no question that when we get in front of the right customer? When we have the chance to educate? When we at the time show them the wealth of data around VASCEPA and the unmet need, that VASCEPA can, in fact, meet for a number of those patients it benefits us. Regarding the markets that are most important to us as we spoke about, the UK is very important.

因此，我們必須非常有選擇性地選擇與誰交談，確保我們仔細識別患者並非常清楚地傳達 VASCEPA 臨床數據的優勢。但它確實打開了機會，並增加了降低心血管風險的機會。毫無疑問，當我們遇到合適的客戶時？我們什麼時候有機會接受教育？當我們當時向他們展示有關 VASCEPA 的豐富數據和未滿足的需求時，VASCEPA 事實上可以滿足許多患者的需求，這使我們受益。正如我們所說，對於我們最重要的市場，英國非常重要。

We focused on the EU5. Right now, we've launched the UK first and the EU5. And the changes we've made last year, as commented on during the earlier portion of the call, those changes are taking hold and we're seeing some acceleration. We're seeing an increase in demand, we're seeing an increase in the number of patients.

我們重點關注歐盟五國。目前，我們首先推出了英國和 EU5。正如我們在電話會議前半部分所評論的那樣，我們去年所做的改變正在發生，而且我們看到了一些加速。我們看到需求增加，患者數量增加。

We've got a long way to go, but we're pleased with the organization and the drive of the organization. We're seeing it in the performance and we're really counting on the UK to accelerate. There's a lot of potential there. Spain launched more recently and we are very encouraged with what we've seen in Spain.

我們還有很長的路要走，但我們對組織和組織的動力感到滿意。我們在表演中看到了這一點，我們真的指望英國能夠加速。那裡有很大的潛力。西班牙最近推出，我們對西班牙所看到的情況感到非常鼓舞。

There's tremendous execution. It's a very focused strategy, focused on the select group of patients that were referenced in the earlier portion of the call, particularly around acute coronary syndrome. They're focused on 2,500 physicians, primarily specialists, and covering 80% of the market. Spain has also shown that there's promotion sensitivity that when we have the time to promote VASCEPA/VAZKEPA.

有巨大的執行力。這是一個非常有針對性的策略，重點關注電話會議前面部分提到的特定患者群體，特別是急性冠狀動脈綜合徵患者。他們專注於 2,500 名醫生（主要是專家），涵蓋 80% 的市場。西班牙也表明，當我們有時間推廣 VASCEPA/VAZKEPA 時，就會產生促銷敏感度。

As we did in the US, physicians respond. And we know over time, if we continue to execute that, we'll continue to see that growth. And then, China is another market we're very excited about. It's an enormous market.

正如我們在美國所做的那樣，醫生做出了回應。我們知道，隨著時間的推移，如果我們繼續執行這一點，我們將繼續看到這種成長。然後，中國是我們非常興奮的另一個市場。這是一個巨大的市場。

We have a strong partner there. We just got the cardiovascular risk reduction indication. They are working to get. So in China, Eddingpharm has launched with a very high triglyceride indication initially similar to what we did in the US. They now have the cardiovascular risk reduction indication.

我們在那裡有一個強大的合作夥伴。我們剛剛得到了降低心血管風險的指徵。他們正在努力獲得。因此，Eddingpharm 在中國推出了非常高的三酸甘油酯適應症，最初與我們在美國的做法類似。他們現在有降低心血管風險的指徵。

And the next step is to get on the NRDL, which is the national drug listing that will reimburse for a much broader population. So not only will we have the cardiovascular risk reduction indication, which is essentially, if it's like the US, 10 times the size of the market, a very high triglycerides.

下一步是加入國家醫保目錄，這是國家藥品目錄，將為更廣泛的人群提供報銷。因此，我們不僅有降低心血管風險的指標，本質上，如果像美國一樣，市場規模是市場規模的 10 倍，三酸甘油酯非常高。

But it'll be reimbursed for so many of those patients nationally as well. We look forward to that toward the end of the year. Edding is working hard to get that listing. And if successful, it'll be January 1.

但全國各地許多患者的費用也將獲得報銷。我們期待著今年底的到來。艾丁正在努力爭取這份清單。如果成功的話，那就是 1 月 1 日。

And we're expecting significant growth in China going into 2025. So we've got some markets and then there are other markets where we're still seeking reimbursement and we'll be ready to launch and execute in those markets as well. I hope I answer your questions

我們預計到 2025 年中國將顯著成長。因此，我們有一些市場，還有其他市場，我們仍在尋求補償，我們也準備在這些市場中啟動和執行。我希望我能回答你的問題

Jessica Fye, JP Morgan

潔西卡‧菲伊，摩根大通

Great. Good morning. Thanks for taking my questions. With the several generics launching in the US over the past six months and the impact on net selling price, can you talk about how we should think about US net price in the back half relative to what we saw in the second quarter?

偉大的。早安.感謝您回答我的問題。鑑於過去六個月在美國推出的幾種仿製藥及其對淨售價的影響，您能否談談相對於我們在第二季度看到的情況，我們應該如何看待下半年的美國淨價？

And then, for Europe, can you speak a little bit more to which country is contributing most to quarterly sequential growth? And also just tell us how much the supply shipments to the partners in Greece and Israel contributed in the quarter? Thank you.

然後，對於歐洲，您能多談談哪個國家對季度連續成長的貢獻最大嗎？請告訴我們本季向希臘和以色列合作夥伴的供應量貢獻了多少？謝謝。

Sure. Thank you for the questions and nice to hear from you. I'll comment on the market dynamics in the US, and Tom may want to comment on the impact on net selling price. There were three additional generics that entered the market in Q2. What we haven't seen is a consistent, we monitor very carefully the pricing, the net cost, the discount that the generics are giving, and we haven't seen consistent behaviors across the generic category.

當然。感謝您的提問，很高興收到您的來信。我將評論美國的市場動態，湯姆可能想評論對淨售價的影響。第二季還有另外三種仿製藥進入市場。我們沒有看到的是一致的，我們非常仔細地監控仿製藥提供的定價、淨成本和折扣，我們沒有看到整個仿製藥類別的一致行為。

Nevertheless, of course, we are getting more pressure because we've said for years now that it's a very dynamic market, increasing generic size market, and it's requiring us to, as we compete on price, to dig deeper on the rebate side.

儘管如此，當然，我們面臨著更大的壓力，因為我們多年來一直表示，這是一個非常有活力的市場，通用尺寸市場不斷增加，並且要求我們在價格競爭時，在回扣方面進行更深入的挖掘。

Right now, we've been able to maintain our leadership position other than the CVS commercial plan that we lost starting in Q3. So that puts pressure on us. And of course, going into 2025, we expect the rebates to go up as well and give additional pressure, downward pressure on the NSP. Tom, I don't know if you want to add any additional color, specifics NSP.

目前，除了我們從第三季開始失去的 CVS 商業計劃之外，我們已經能夠保持我們的領先地位。所以這給我們帶來了壓力。當然，進入 2025 年，我們預計回扣也會增加，並給 NSP 帶來額外的壓力和下行壓力。湯姆，我不知道你是否想添加任何額外的顏色，具體是 NSP。

Sure. Jess, related to second half of the year, we expect to see continued price decline in the second half of the year related to pricing and specifically related to mix as we lost the key commercial plan, our volume would be heavier in Medicare Part D. We expect to see high single digit price decline versus what we saw in the first half. So continuous price decline.

當然。Jess，與今年下半年相關，我們預計下半年與定價相關的價格將持續下降，特別是與組合相關的價格，因為我們失去了關鍵的商業計劃，我們的醫療保險D 部分的銷量將會更大。所以價格持續下跌。

And then, Jess, I think your second question was related to the supply shipments related to the Greece – and to Greece and Israel. We don't give country-by-country revenue, but I can say about 15% to 20% of our total revenue in Europe was related to the supply shipments to those particular countries, which we're very excited about. We have partners in place and ready to expand in the market in Greece and Israel.

然後，傑西，我認為你的第二個問題與希臘以及希臘和以色列的供應運輸有關。我們不提供逐個國家的收入，但我可以說我們在歐洲總收入的大約 15% 到 20% 與向這些特定國家的供應運輸有關，我們對此感到非常興奮。我們已經有合作夥伴，準備拓展希臘和以色列的市場。

And Jess, to the question you raised about the countries, as Tom said, we don't give specific numbers for each of the countries. But what we could say, as we've said is UK, the focus is on the EU5, -- those -- the two countries that we've launched out of the EU5, UK and Spain, we're seeing more growth. We have a long way to go. We just started in Spain, but are very encouraged.

傑西，對於你提出的有關國家的問題，正如湯姆所說，我們不會給出每個國家的具體數字。但我們可以說，正如我們所說，英國的重點是歐盟五國，我們從歐盟五國中推出的兩個國家，英國和西班牙，我們看到了更多的成長。我們還有很長的路要走。我們剛開始在西班牙，但受到了極大的鼓舞。

We announced Portugal, which will complement what we're seeing in Iberia and then UK, the changes we've made, the way the team is executing we expect growth as well. We know both markets have significant potential.

我們宣布了葡萄牙，這將補充我們在伊比利亞半島和英國所看到的，我們所做的改變，團隊執行的方式，我們也期望增長。我們知道這兩個市場都具有巨大潛力。

Great. Are there other countries we should anticipate seeing reimbursement come online in 2024?

偉大的。我們預計還有其他國家會在 2024 年實現報銷嗎？

Well, our hope is we're working closely with the authorities in Italy and we're hopeful that we can find that win-win with the reimbursement authorities. And if so then our hope would be by the end of the year. We'd see that in Italy. France, we have we're at the stage where respect EPA should be very helpful in bolstering our clinical dossier, and that'll allow us to ramp up the reimbursement discussions there as well. But we don't expect that in 2024.

嗯，我們希望與義大利當局密切合作，並希望能夠與報銷當局實現雙贏。如果是這樣，那麼我們的希望將是在今年年底。我們會在義大利看到這一點。法國，我們正處於一個階段，尊重 EPA 應該對支持我們的臨床檔案非常有幫助，這也將使我們能夠在那裡加強報銷討論。但我們預計 2024 年不會出現這種情況。

Paul Choi, Goldman Sachs.

保羅‧崔，高盛。

Hi. Good morning, Aaron. Good morning, Tom. Thank you for taking our questions. My first question relates to China, and can you maybe comment on when your partner there expects potential inclusion in the NRDL? Would it be permissible for 2025 or should we anticipate 2026?

你好。早上好，亞倫。早上好，湯姆。感謝您接受我們的提問。我的第一個問題與中國有關，您能否評論一下您在那裡的合作夥伴預計何時可能被納入國家醫保目錄？2025 年是否允許，還是應該預期 2026 年？

My second question is, this quarter you benefited from the one time milestone for the CV risk reduction, which let you guys be operating breakeven, but without that I think you would have been at a loss. So my question there is given that one time milestone, as well as the formulary loss with regard to CV's anthem. Can you maybe just comment on what is the OpEx flexibility there? And is the aim to remain breakeven from an enterprise perspective, or will you continue to spend in the back half of the year supporting the ex-US launch? Thank you.

我的第二個問題是，本季您從降低履歷風險的一次性里程碑中受益，這讓你們能夠實現損益平衡，但如果沒有這一點，我認為你們將會虧損。所以我的問題是考慮到這個里程碑，以及關於 CV 國歌的規定損失。您能否簡單評論一下那裡的營運支出靈活性是什麼？從企業角度來看，目標是維持損益平衡，還是會在今年下半年繼續投入資金支持在美國以外地區的推出？謝謝。

Thanks, Paul. So regarding NRDL, because of when the cardiovascular risk reduction indication was granted, which was before the end of June, it's very possible that VASCEPA is on the NRDL for January 1, 2025. There are a number of steps that that we need to go through, Edding needs to go through, but that would be hopeful and of course, that would be significant. Tom, do you want to comment on the milestone in opex?

謝謝，保羅。因此，就醫保目錄而言，由於心血管風險降低適應症的批准時間是在 6 月底之前，因此 VASCEPA 很可能會在 2025 年 1 月 1 日進入醫療保健目錄。我們需要經歷許多步驟，埃丁也需要經歷，但這將是充滿希望的，當然，這將是重要的。湯姆，您想對營運支出的里程碑發表評論嗎？

Sure. Thanks for the question, Paul, good to hear from you. And you're correct. We were benefited from a 15 million milestone receipt from adding the cardiovascular risk reduction. And with that we also had a change in accounting estimate related to $4 million of deferred revenue that we recognized in the quarter as well from revenue recognition. So your math is correct, related to our plans. Our plans are to continue to invest in expanding into Europe with the levels and depending on pricing and reimbursement decisions that are upcoming. We do expect a slight declining cash for the next couple quarters, right.

當然。謝謝你的提問，保羅，很高興收到你的來信。你是對的。由於增加了心血管風險降低功能，我們獲得了 1500 萬美元的里程碑收入。同時，我們也對與我們在本季確認的 400 萬美元遞延收入以及收入確認相關的會計估計進行了更改。所以你的數學是正確的，與我們的計劃有關。我們的計劃是繼續投資擴大到歐洲的規模，並取決於即將到來的定價和報銷決策。我們確實預計未來幾季現金將略有下降，對吧。

Given the fact that we're continuing to invest into Europe at this point in time, you probably saw from our announcement we have been very prudent on cash. We've maintained cash over the last eight quarters. We have looked at our operating expense base.

鑑於我們目前正在繼續投資歐洲，您可能從我們的公告中看到我們對現金非常謹慎。我們在過去八個季度一直保持現金。我們研究了我們的營運費用基礎。

We reduced 50 million annually on an annualized basis. So we're going to continue to monitor our operating expenses and to invest prudently. But we do expect somewhat of a decline remainder of the year.

以年計算，我們每年減少了 5,000 萬。因此，我們將繼續監控我們的營運支出並謹慎投資。但我們確實預計今年剩餘時間會下降。

Roanna Ruiz, Leerink.

羅安娜·魯伊斯，萊林克。

-- Hi, Aaron. Sorry, this is Maisie on for Roanna Ruiz. Thanks for taking the question. Given the recent approval of the cardiovascular risk reduction indication for VASCEPA by the NMPA in China, could you please elaborate on what you think that market opportunity looks like in China? And kind of just what are the exact next steps that ending would need to take to launch commercially?

——嗨，亞倫。抱歉，我是羅安娜·魯伊斯 (Roanna Ruiz) 的梅西。感謝您提出問題。鑑於中國 NMPA 最近批准了 VASCEPA 的心血管風險降低適應症，您能否詳細說明您認為中國的市場機會是什麼？那麼，為了實現商業化，接下來需要採取哪些具體步驟呢？

So, well they've already launched. First of all, the opportunity for cardiovascular risk reduction is around $300 million for the total market. In terms of VASCEPA numbers in terms of which – what the size of the population that meets the label criteria, I'm not sure offhand, but certainly, of course, a subset of that is to say, it's a very large market. Edding has already launched with a very high triglyceride indication.

所以，他們已經啟動了。首先，降低心血管風險的機會整個市場約為3億美元。就 VASCEPA 數據而言——符合標籤標準的人口規模是多少，我不確定，但當然，其中的一個子集就是說，這是一個非常大的市場。Edding 已經推出了具有非常高三酸甘油酯指標的產品。

But what they'll be able to do is so they have about 100 reps, they'll focus on about 300 hospitals. And then, once it's on NRDL, then they'll see how the progress is and make decisions, prudent decisions, as to how they can expand.

但他們能做的就是擁有大約 100 名代表，他們將專注於大約 300 家醫院。然後，一旦進入國家醫保目錄，他們就會看到進展如何，並就如何擴展做出決策，審慎的決策。

And, again hopefully NRDL is January 1. And even between now and January 1, because of the cardiovascular risk reduction indication, perhaps they'll see the trajectory ramp up, as we did in the US, and they'll be able to make decisions on expansion even prior to NRDL. But I'll leave it to them. They're closer to the market.

並且，再次希望 NRDL 是 1 月 1 日。即使從現在到 1 月 1 日，由於心血管風險降低的跡象，也許他們會看到軌跡上升，就像我們在美國所做的那樣，他們甚至能夠在 NRDL 之前就擴大規模做出決定。但我會把它留給他們。他們離市場更近。

Tom, do you want to. I know you're close to it as well. Why don't you comment?

湯姆，你願意嗎？我知道你也很接近它。為什麼不評論？

Yes. Now, I'd just like to add to that, Aaron, so as you mentioned population of 300 million eligible patients under the label. In addition, just keep in mind the economics – with China with our partner, tiered royalty structure, no cost infrastructure that we have, and then subject to sales milestones. We're very excited about the overall opportunity. Economics in favor as Aaron mentioned earlier, with our partner, we have a very good partner in China to support us.

是的。現在，我想補充一點，Aaron，正如您所提到的，該標籤下有 3 億符合條件的患者。此外，請記住我們與中國合作夥伴的經濟狀況、分層特許權使用費結構、我們擁有的免費基礎設施，然後受銷售里程碑的約束。我們對整個機會感到非常興奮。經濟上有利正如Aaron之前提到的，與我們的合作夥伴一起，我們在中國有一個非常好的合作夥伴來支持我們。

And just for all of our partners, now that we have a number of partners, we work very closely with them to help them succeed. We have wealth of experience over a decade commercializing it, not to mention all the other regulatory and clinical and medical affairs side. Everything that we can share with them, we work closely to help them succeed and we look forward to a number of them. But of course, given the size of China, that's significant and we're excited about that.

對於我們所有的合作夥伴來說，既然我們有很多合作夥伴，我們就與他們密切合作，幫助他們取得成功。我們在將其商業化方面擁有十多年的豐富經驗，更不用說所有其他監管、臨床和醫療事務方面的經驗了。我們可以與他們分享的一切，我們密切合作，幫助他們取得成功，我們期待他們中的一些人。當然，考慮到中國的幅員遼闊，這意義重大，我們對此感到興奮。

Great. Thanks. Just one follow up, Aaron is how should we also think about the sales force increase in like regional personnel as you guys start to ramp up more in the European markets?

偉大的。謝謝。只是一個後續問題，亞倫，當你們開始在歐洲市場上增加更多業務時，我們應該如何考慮區域人員等銷售人員的增加？

So we've been very judicious about first it comes down to the reimbursement side and the patient criteria and then the analytics around who we target. So we're starting, as I mentioned in the earlier portion of our comments, we're focused on, there's a big focus on the ACS patients. That's a patient population that are readily identifiable. They clearly have unmet need.

因此，我們非常明智，首先涉及報銷方面和患者標準，然後圍繞我們的目標對象進行分析。所以我們開始，正如我在前面的評論中提到的，我們的重點是 ACS 患者。這是一個很容易辨識的患者群。他們顯然有未滿足的需求。

They see the physicians more often. They're more inclined to get combination therapy. More inclined to need combination therapy beyond just standard of care. So it's a real opportunity and it also allows us to focus on cardiologists or specialists, depending on the market.

他們更頻繁地去看醫生。他們更傾向於接受聯合治療。更傾向於需要標準護理以外的聯合治療。因此，這是一個真正的機會，它也使我們能夠根據市場的不同，專注於心臟科醫生或專家。

So based on when we launch in each of the markets, it depends on how we get started and then expand from there. So there are a lot of variables. Every country is different, but will get started with a more specialty approach. We're doing that, for example, in Spain and the UK.

因此，根據我們在每個市場推出的時間，這取決於我們如何開始並從那裡擴展。所以存在著很多變數。每個國家都是不同的，但都會以更專業的方法開始。例如，我們正在西班牙和英國這樣做。

We're very efficient in our focus. Once we get a foothold, those patients tend to go back to the GP audiences and then that'll be time for us to expand. So that's how we think about it. As a smaller company, we try to be very prudent about our investment and get traction first, but it's a balance with getting the opportunity and accelerated lift as soon as we have the opportunity to launch. I hope that makes sense.

我們的專注力非常有效率。一旦我們站穩腳跟，這些患者往往會回到全科醫生的受眾群體中，然後我們就到了擴張的時候了。這就是我們的想法。作為一家規模較小的公司，我們對投資非常謹慎，並首先獲得吸引力，但這是與獲得機會和一旦有機會推出就加速提升之間的平衡。我希望這是有道理的。

(Operator Instructions) We have reached the end of the question and answer session. And I will now turn the call over to Aaron for closing remarks.

（操作員說明）我們的問答環節已經結束。現在，我將把電話轉交給亞倫，讓他發表結束語。

Thank you, Holly. Appreciate it. And thanks to everybody for your continued interest in Amarin. We greatly appreciate it. Thank you for your questions. Thanks for taking the time today. We hope it was helpful, and everyone has a good day. Thank you.

謝謝你，霍莉。欣賞它。感謝大家對 Amarin 的持續關注。我們非常感激。謝謝您的提問。感謝您今天抽出時間。我們希望這對您有所幫助，並祝福每個人都有美好的一天。謝謝。

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，您現在可以掛斷電話了。感謝您的參與。