Novocure Ltd (NVCR) 2024 Q3 法說會逐字稿

Welcome to the Novocure Q3 2024 earnings conference call. (Operator Instructions)

歡迎參加 Novocure 2024 年第三季財報電話會議。（操作員指令）

Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Ingrid Goldberg. Please go ahead.

請注意，今天的會議正在錄音。現在，我想將會議交給今天的發言人英格麗德‧戈德堡 (Ingrid Goldberg)。請繼續。

Good morning, and thank you for joining us to review Novocure's third-quarter 2024 performance. I am on the phone this morning with our Executive Chairman, Bill Doyle; our CEO, Asaf Danziger; and our CFO, Ashley Cordova. Other members of our executive leadership team will be available for Q&A.

早安，感謝您加入我們回顧 Novocure 2024 年第三季的業績。今天早上我與我們的執行主席比爾·道爾通了電話；我們的執行長 Asaf Danziger；以及我們的財務長 Ashley Cordova。我們的執行領導團隊的其他成員將回答您的提問。

For your reference, slides accompanying this earnings release can be found on our website, www.novocure.com, on the investor relations page under quarterly reports.

供您參考，本次收益報告的幻燈片可以在我們的網站 www.novocure.com 的季度報告下的投資者關係頁面上找到。

Before we start, I would like to remind you that our discussions during this conference call will include forward-looking statements, and actual results could differ materially from those projected in these statements. These statements involve a number of risks and uncertainties, some of which are beyond our control and are described from time to time in our SEC filings. We do not intend to update publicly any forward-looking statement except as required by law.

在我們開始之前，我想提醒您，我們在本次電話會議中的討論將包括前瞻性陳述，實際結果可能與這些陳述中的預測有重大差異。這些聲明涉及許多風險和不確定性，其中一些是我們無法控制的，並且會不時在我們向美國證券交易委員會提交的文件中描述。除非法律要求，我們無意公開更新任何前瞻性聲明。

Where appropriate, we refer to non-GAAP financial measures to evaluate our business, specifically adjusted EBITDA, a measure of earnings before interest, taxes, depreciation, amortization, and share-based compensation. We believe adjusted EBITDA is an important metric as it removes the impact of earnings attributable to our capital structure, tax rate, and material non-cash items, and thus reflects the financial value generated by our business.

在適當的情況下，我們會參考非公認會計準則財務指標來評估我們的業務，特別是調整後的 EBITDA，即息稅折舊攤銷前利潤和股權激勵前利潤的衡量指標。我們認為調整後的 EBITDA 是一個重要指標，因為它消除了歸因於我們的資本結構、稅率和重大非現金項目的收益的影響，從而反映了我們業務創造的財務價值。

Reconciliations of non-GAAP-to-GAAP financial measures are included in our press release, earnings slides, and in our Form 8K filed with the SEC today. These materials can also be accessed from the Investor Relations page of our website.

非 GAAP 與 GAAP 財務指標的對帳表包含在我們的新聞稿、收益幻燈片以及今天向美國證券交易委員會 (SEC) 提交的 8K 表中。您也可以從我們網站的投資者關係頁面存取這些資料。

Following our prepared remarks today, we will open the line for your questions. I will now turn the call over to our Executive Chairman, Bill Doyle.

在今天的準備好的發言之後，我們將開放熱線來回答大家的提問。現在我將把電話轉給我們的執行主席比爾·道爾。

Thank you, Ingrid, and good morning. At Novocure, our mission is to extend survivals in some of the most aggressive forms of cancer. Our efforts have focused largely on glioblastoma, but with the recent approval of Optune Lua for non-small cell lung cancer, we are launching our next large indication.

謝謝你，英格麗德，早安。在 Novocure，我們的使命是延長某些最具侵襲性的癌症患者的生存期。我們的努力主要集中在膠質母細胞瘤上，但隨著 Optune Lua 最近獲得批准用於治療非小細胞肺癌，我們正在啟動下一個重大適應症。

Launching tumor treating fields therapy in non-small cell lung cancer is an important achievement for Novocure. We are eager to bring a new and urgently needed therapeutic option to patients in need.

推出針對非小細胞肺癌的腫瘤電場治療是Novocure的重要成就。我們渴望為有需要的患者帶來新的、急需的治療選擇。

This morning, we will begin with a discussion of our non-small cell lung cancer approval and launch plan, followed by a GBM performance review, clinical pipeline update, and review of Novocure's third quarter financial performance.

今天上午，我們將首先討論我們的非小細胞肺癌批准和啟動計劃，然後進行 GBM 績效評估、臨床管道更新以及 Novocure 第三季度財務業績評估。

Two weeks ago, the FDA approved our PMA for Optune Lua to treat post-platinum metastatic non-small cell lung cancer together with either an immune checkpoint inhibitor or docetaxel. As you know, TTFields therapy is already approved to treat glioblastoma and mesothelioma, rare forms of brain and thoracic cancer.

兩週前，FDA 批准了我們的 Optune Lua 上市前批准 (PMA)，用於與免疫檢查點抑制劑或多西他賽聯合治療鉑後轉移性非小細胞肺癌。如您所知，TTFields 療法已被批准用於治療膠質母細胞瘤和間皮瘤，以及罕見的腦癌和胸癌。

Our approval to treat non-small cell lung cancer means our innovative therapy will be an option for a large and growing patient population with an urgent and unmet need for effective therapies in the second line.

我們獲得批准用於治療非小細胞肺癌，這意味著我們的創新療法將成為越來越多對二線有效療法有迫切且未滿足需求的患者的一種選擇。

For months, we have been preparing for this launch. The lung team was hired over the summer and has undergone extensive scientific training. We have had a substantial presence at oncology congresses around the world, including ELCC, ASCO, WCLC, and ESMO, providing an opportunity for physicians to learn about TTFields therapy.

幾個月來，我們一直在為這次發布做準備。該肺部研究團隊於今年夏天受聘，並接受了廣泛的科學訓練。我們在世界各地的腫瘤學會議上都有大量發言，包括ELCC、ASCO、WCLC和ESMO，為醫生提供了了解TTFields療法的機會。

We have had numerous advisory boards to ensure we fully understand the physician and patient needs. Our marketing team is prepared with a suite of resources for providers, care teams, patients, and caregivers. Physician and patient-focused websites were launched the day after approval, and our sales team was fully trained and in the field the following Monday.

我們設有多個顧問委員會，以確保我們充分了解醫生和患者的需求。我們的行銷團隊為供應商、護理團隊、患者和護理人員準備了一套資源。以醫生和患者為中心的網站在獲得批准的第二天就上線了，我們的銷售團隊在接下來的周一完成了全面培訓並投入現場。

We are pleased to report that our first round of physicians have completed certification, and we received our first lung prescription shortly after approval. Our launch is well underway.

我們很高興地報告，我們的第一批醫生已經完成認證，並且在批准後不久我們就收到了第一張肺部處方。我們的發表會正在順利進行中。

We are also preparing for launch in Germany and Japan in anticipation of regulatory approvals. As noted last quarter, the new MDR process has lengthened regulatory review timelines in Europe. While the review process has taken longer than originally projected, we remain hopeful for a final decision in the coming months.

我們也正在為在德國和日本推出產品做準備，以期獲得監管部門的批准。正如上個季度所指出的，新的 MDR 流程延長了歐洲的監管審查時間。雖然審查過程比最初預計的要長，但我們仍然希望在未來幾個月內做出最終決定。

In Japan, we have submitted our application to the PMDA, and productive conversations are ongoing. We will be launch-ready upon approval in both of these important markets.

在日本，我們已經向PMDA提交了申請，目前正在進行富有成效的對話。一旦獲得這兩個重要市場的批准，我們就會做好推出產品的準備。

I am incredibly proud of the efforts of our team to bring TTFields therapy to non-small cell lung cancer patients. So many people across Novocure have contributed to this milestone.

我為我們團隊為非小細胞肺癌患者帶來 TTFields 療法的努力感到無比自豪。Novocure 的許多人都為這一里程碑做出了貢獻。

Also, we would not have been able to celebrate this moment today without the partnership and commitment of our patients, their families and caregivers, and the physicians, researchers, and healthcare professionals that have taken part in our clinical trials. Thank you all.This is an important achievement for patients.

此外，如果沒有我們的患者、他們的家人和照護者以及參與臨床試驗的醫生、研究人員和醫療保健專業人員的合作和承諾，我們今天就不可能慶祝這一時刻。謝謝大家。

As we prepare for a new chapter at Novocure, we are pleased to implement planned changes to our executive team that will position Novocure for long-term success. Last month, we announced the retirement at the end of this year of our CEO, Asaf Danziger. Asaf has been with Novocure for 22 years and has shepherded our company through our successful clinical trials, regulatory approvals, engineering advances, and the launch of our successful GBM business.

在我們準備開啟 Novocure 新篇章之際，我們很高興對我們的執行團隊實施計劃中的變動，這將使 Novocure 獲得長期成功。上個月，我們宣布執行長阿薩夫·丹齊格 (Asaf Danziger) 將於今年底退休。Asaf 在 Novocure 工作了 22 年，帶領公司完成了成功的臨床試驗、監管部門批准、工程進步以及成功的 GBM 業務的推出。

Under Asaf's leadership, we have grown from a small team in Israel to an international company of over 1,400 employees. We knew the day would come when Asaf would choose to retire, and to prepare, we have been cultivating a strong bench of leaders.

在阿薩夫的領導下，我們從以色列的一個小團隊發展成為一家擁有 1,400 多名員工的國際公司。我們知道阿薩夫選擇退休的那一天終究會到來，為了做好準備，我們一直在培養一群強大的領導團隊。

When the Board began the process to identify Asaf's successor, our goal was to find a candidate with substantial institutional knowledge, experience managing an expanding global organization, and a deep understanding of our clinical and commercial opportunities.

當董事會開始尋找阿薩夫的繼任者時，我們的目標是找到一位擁有豐富機構知識、管理不斷擴張的全球組織的經驗、以及對我們的臨床和商業機會有深入了解的候選人。

Ashley Cordova embodies all of these characteristics. Ashley has been integral to scaling Novocure's global operations and infrastructure since joining the company in 2014. Her commitment to our patients and strategic vision are exceptional, as is her record of accomplishment as our CFO. We are delighted Ashley has accepted the challenge and confident she is the right choice to drive Novocure's next stage of growth.

阿什利·科爾多瓦 (Ashley Cordova) 體現了所有這些特徵。自 2014 年加入公司以來，Ashley 一直是擴大 Novocure 全球業務和基礎設施不可或缺的一部分。她對我們病患的承諾和策略眼光非常出色，她作為我們財務長的成就也非常出色。我們很高興 Ashley 接受了挑戰，並相信她是推動 Novocure 下一階段發展的正確人選。

This morning, we also announced Christoph Brackmann has joined Novocure as our next CFO, replacing Ashley in this role. Christoph joins Novocure this week and will assume the CFO position on January 1. Christoph was most recently the Senior Vice President of Finance at Moderna, and he brings a wealth of experience in the biotechnology and pharmaceutical industries. Christoph was instrumental to Moderna's scale-up during the COVID pandemic. His external perspective will be an important addition to our executive team.

今天上午，我們也宣布 Christoph Brackmann 已加入 Novocure 擔任我們的下一任財務官，接替 Ashley 擔任這一職位。克里斯托夫 (Christoph) 本週加入 Novocure，並將於 1 月 1 日擔任財務長。Christoph 最近擔任 Moderna 的財務高級副總裁，他在生物技術和製藥行業擁有豐富的經驗。在新冠疫情期間，克里斯托夫對 Moderna 擴大規模發揮了重要作用。他的外部視角對於我們的執行團隊來說將是一個重要的補充。

Finally, in October, Mukund Paravasthu took over as our COO following the retirement of Wilco Groenhuysen. With these additions to our executive leadership, the board and I believe we have the team in place that will lead Novocure to the next levels of growth.

最後，10 月份，Wilco Groenhuysen 退休後，Mukund Paravasthu 接任我們的營運長。隨著這些高階主管團隊的加入，董事會和我相信我們已經擁有了一支能夠帶領 Novocure 邁向新一輪成長的團隊。

Before I pass the call over to Ashley, I would like to extend my personal thanks to Asaf for his 22 years of dedication to Novocure. Asaf and I were young men when we embarked on the journey to bring tumor-treating field therapy to patients, and I know we would not have succeeded and Novocure would not exist today without Asaf. Ashley?

在我將電話轉給阿什利之前，我想向阿薩夫 22 年來對 Novocure 的奉獻表示我個人的感謝。當阿薩夫和我踏上為患者帶來腫瘤治療場療法的旅程時，我們都很年輕，我知道，如果沒有阿薩夫，我們就不會成功，Novocure 也不會有今天的存在。阿什利？

Thank you, Bill. It is an exciting time to be at Novocure, and I am both humbled and energized by the opportunity to lead this company into a bright future.

謝謝你，比爾。現在是加入 Novocure 的激動人心的時刻，我既感到謙卑，又能有機會帶領這家公司走向光明的未來。

Throughout 2024, we have taken steps to return our GBM business to growth through a focus on prescription conversion, patient persistence, and cross-functional alignment.

在整個 2024 年，我們採取措施，透過專注於處方轉換、病患堅持和跨職能協調，使我們的 GBM 業務恢復成長。

This quarter, we saw the fruits of these initiatives across all major markets, with global active patient growth of 13% year over year. We ended the quarter with a record 4,113 active patients on therapy, breaking the 4,000 patient threshold for the first time. This helped us deliver 22% year-over-year top-line growth.

本季度，我們在所有主要市場都看到了這些措施的成果，全球活躍患者較去年同期成長了 13%。截至本季度，我們共有 4,113 名活躍患者接受治療，創下歷史新高，首次突破 4,000 名患者的門檻。這幫助我們實現了同比成長22%的營業額成長。

We have also seen substantial progress across our clinical programs. Our next clinical milestone will be top-line data from our Phase 3 PANOVA trial later this year. PANOVA-3 is studying the use of tumor-treating field therapy with gemcitabine and nab-paclitaxel for the treatment of unresectable, locally advanced pancreatic cancer. We recently completed patient follow-up and are now finalizing data collection and analyses.

我們的臨床項目也取得了實質進展。我們的下一個臨床里程碑將是今年稍後第 3 階段 PANOVA 試驗的頂線數據。PANOVA-3 正在研究使用吉西他濱和白蛋白紫杉醇的腫瘤治療場療法治療無法切除的局部晚期胰腺癌。我們最近完成了患者的跟踪，目前正在完成數據收集和分析。

This quarter, we also completed enrollment in our Phase 2 PANOVA-4 trial, which adds [Roche's] immune checkpoint inhibitor atezolizumab to tumor-treating field therapy, gemcitabine, and nab-paclitaxel for the treatment of metastatic pancreatic cancer.

本季度，我們也完成了第 2 階段 PANOVA-4 試驗的招募，該試驗將 [羅氏] 免疫檢查點抑制劑阿特珠單抗添加到腫瘤治療領域治療、吉西他濱和白蛋白紫杉醇中，用於治療轉移性胰腺癌。

As a reminder, PANOVA-4 was launched in mid-2023, just five quarters ago, and was designed to enroll 76 patients. We are pleased with the excitement and engagement of the pancreatic cancer community around this trial and are eager to better understand the potential of tumor-treating field therapy in this setting.

提醒一下，PANOVA-4 於 2023 年中期（僅五個季度前）推出，旨在招募 76 名患者。我們很高興看到胰臟癌社群對這項試驗的興奮和參與，並渴望更好地了解腫瘤治療場療法在這種環境下的潛力。

Our next indication to be submitted to the FDA for PMA review will be the treatment of brain metastases for non-small cell lung cancer. As a reminder, we presented data from the Phase 3 METIS trial at ASCO in June. METIS met its primary endpoint, demonstrating a median time to intracranial progression of 21.9 months for patients using tumor-treating field therapy, compared to 11.3 months for patients randomized to the control.

我們下一個將提交給FDA進行PMA審查的適應症是治療非小細胞肺癌腦轉移。提醒一下，我們在 6 月的 ASCO 上展示了第 3 階段 METIS 試驗的數據。METIS 達到了其主要終點，顯示使用腫瘤治療場療法的患者顱內進展的中位數時間為 21.9 個月，而隨機接受對照組的患者顱內進展的中位數時間為 11.3 個月。

Importantly, the METIS data showed patients treated with tumor-treating fields maintained quality of life and cognitive function, key challenges in the treatment of brain metastases. We are pleased to announce today that the FDA has granted breakthrough device designation for the use of tumor-treating field therapy for brain metastases from non-small cell lung cancer.

重要的是，METIS 數據顯示，接受腫瘤治療場治療的患者維持了生活品質和認知功能，這是治療腦轉移的關鍵挑戰。今天我們很高興地宣布，FDA 已授予使用腫瘤治療場療法治療非小細胞肺癌腦轉移的突破性設備稱號。

Breakthrough device designation gives us more frequent, faster, and interactive access to the FDA review team and senior management during the review process, priority review of our marketing application upon filing, and expedited review of pre-PMA manufacturing and quality systems compliance inspection. We expect to file the PMA in early 2025.

突破性設備指定使我們在審查過程中能夠更頻繁、更快、更具互動性地與 FDA 審查團隊和高級管理層進行接觸，在提交營銷申請時獲得優先審查，並加快審查 PMA 前的製造和質量體系合規性檢查。我們預計將在 2025 年初提交 PMA。

Following on the success of the LUNAR trial in metastatic non-small cell lung cancer are our Phase 3 LUNAR-2 and Phase 2 LUNAR-4 trials.

繼轉移性非小細胞肺癌的 LUNAR 試驗成功之後，我們又進行了第 3 期 LUNAR-2 和第 2 期 LUNAR-4 試驗。

LUNAR-2 is studying tumor-treating fields together with platinum chemotherapy and pembrolizumab in the first line. LUNAR-4 is studying treatment with tumor-treating field therapy and pembrolizumab in the second line, following first-line treatment with a checkpoint inhibitor and platinum-based chemotherapy. Both are open and actively enrolling patients and important to our ongoing efforts to establish and increase adoption of tumor-treating field therapy and non-small cell lung.

LUNAR-2正在研究以鉑類化療和帕博利珠單抗為第一線的腫瘤治療領域。LUNAR-4 正在研究採用腫瘤治療場療法和派姆單抗進行二線治療，第一線治療採用檢查點抑制劑和鉑類化療。兩項研究均開放並積極招募患者，這對於我們持續努力建立和增加腫瘤治療領域治療和非小細胞肺癌的採用至關重要。

We also have two ongoing Phase 3 trials in GBM, TRIDENT and Keynote D58. The TRIDENT trial is studying the benefit of starting Optune Gio earlier in the patient journey concurrent with chemoradiation rather than following chemoradiation. TRIDENT completed enrollment last January and patients are currently in the two-year follow-up period with data expected in 2026.

我們也在 GBM、TRIDENT 和 Keynote D58 中進行兩項 3 期試驗。TRIDENT 試驗正在研究患者在放化療的同時而不是在放化療之後開始使用 Optune Gio 的益處。TRIDENT 於去年 1 月完成患者招募，目前患者處於兩年的追蹤期，預計數據將在 2026 年公佈。

We are initiating sites for the Keynote D58 trial, studying the addition of pembrolizumab to the current GBM standard of care, Optune Gio plus temozolomide following chemoradiation. Keynote D58 is an exciting opportunity to build upon the results of the Phase 2 to the top trial and study the benefits of using tumor treating fields therapy with immune checkpoint inhibitors in newly diagnosed GBM.

我們正在啟動 Keynote D58 試驗的站點，研究將 pembrolizumab 添加到目前的 GBM 標準治療中，即在放化療後使用 Optune Gio 加替莫唑胺。主題演講 D58 是一個令人興奮的機會，可以在第 2 階段至第 3 階段試驗的結果基礎上，研究使用腫瘤治療場療法與免疫檢查點抑制劑治療新診斷的 GBM 的益處。

Turning to our financial performance for the third quarter, top-line growth was strong. Q3 net revenues were $155 million, an increase of 22% from the same period last year. The increase was largely driven by active patient growth in our key markets and improved approval rates in the United States. The improved US approval rates contributed $5 million in Q3 net revenues from prior period billing.

回顧我們第三季的財務業績，營收成長強勁。第三季淨營收為1.55億美元，較去年同期成長22%。這一增長主要得益於我們主要市場的活躍患者的成長和美國批准率的提高。美國批准率的提高為第三季的淨收入貢獻了 500 萬美元。

Looking ahead, we do not expect to see an incremental one-time benefit from prior periods as the improved approval rates are now considered in our baseline revenue run rate. Growth margin in the third quarter was 77% compared to 75% in the third quarter of 2023. This improvement was driven by a higher net revenue per patient due to the increase in US approval rates and our strong performance in France.

展望未來，我們預計不會看到前期一次性收益的增量，因為現在我們已將提高的批准率計入基準收入運行率。第三季的成長率為 77%，而 2023 年第三季的成長率為 75%。這一改善是由於美國批准率的提高和我們在法國的強勁表現導致的每位患者淨收入的增加。

Looking ahead, we expect the global launch of our next-generation arrays as a non-small cell lung cancer indication to be headwinds to growth margin. SG&A expenses were $100 million in the third quarter, in line with Q3 2023.

展望未來，我們預計我們的下一代陣列作為非小細胞肺癌適應症的全球推出將對成長利潤率造成阻力。第三季的銷售、一般及行政開支為 1 億美元，與 2023 年第三季持平。

Our sales and marketing expenses increased year over year in support of our lung cancer launch, offset by lower personnel costs and G&A. Research and development expenses in the quarter totaled $52 million, a decrease of 3% from the same period in 2023. Our net loss for the quarter was $31 million, or $0.28 per share.

為了支持我們針對肺癌的研究，我們的銷售和行銷費用逐年增加，但人員成本和一般行政費用的降低抵消了增加。本季研發費用總計 5,200 萬美元，較 2023 年同期下降 3%。本季我們的淨虧損為 3,100 萬美元，即每股 0.28 美元。

Adjusted EBITDA was $2 million, an increase of $31 million compared to the same period last year, and our second quarter in a row with positive adjusted EBITDA. This was largely driven by the increase in net revenues, as well as material benefits from reduced operating expenses resulting from the strategic restructuring we undertook at the end of 2023.

調整後 EBITDA 為 200 萬美元，較去年同期增加 3,100 萬美元，這是我們連續第二季實現調整後 EBITDA 為正。這主要是由於淨收入的成長，以及我們在 2023 年底進行的策略重組所帶來的營運費用減少所帶來的實質效益。

As we continue to invest in growth, profitability remains an important goal and something we are actively driving towards.

隨著我們繼續投資於成長，獲利能力仍然是我們的重要目標，也是我們正在積極努力實現的目標。

As Bill noted earlier, Asaf will be retiring at the end of the year, so this will be his final earnings call. I would like to personally thank Asaf for his friendship and leadership over the past 10 years, and will now turn the call over to him for some parting words.

正如比爾之前提到的，阿薩夫將於今年年底退休，因此這將是他的最後一次財報電話會議。我要親自感謝阿薩夫過去 10 年來的友誼和領導，現在請他講幾句話。

Thank you, Ashley. When I joined Professor Palti, Novocure was a company of a few people in a preclinical lab, working to bring TTFields therapy to the fight against cancer.

謝謝你，阿什利。當我加入帕爾蒂教授時，Novocure 是一家由臨床前實驗室的幾個人組成的公司，致力於將 TTFields 療法應用於對抗癌症。

Today, Novocure is a team of more than 1,400 and is treating thousands of cancer patients across the globe. I am very proud of how far we have come and of the lives we have affected, and I know Novocure is poised for greater things ahead under Ashley's leadership. We have worked together for more than a decade, so I know Ashley has the passion and tenacity needed to take Novocure to the next level.

如今，Novocure 擁有一支超過 1,400 人的團隊，為全球數千名癌症患者提供治療。我為我們所取得的進步和影響到的生活感到非常自豪，我知道在阿什利的領導下，Novocure 將取得更大的成就。我們已經合作了十多年，所以我知道 Ashley 擁有將 Novocure 提升到新水平所需的熱情和毅力。

Ashley has been integral to Novocure's evolution, from small company to global organization, and for ensuring we have had the financial structure and strength to support our growth. There is no one better to lead us into the future.

Ashley 在 Novocure 從小公司發展成為全球組織的過程中發揮了不可或缺的作用，並確保我們擁有支持我們發展的財務結構和實力。沒有人比祂更適合帶領我們走向未來。

I would like to thank all my colleagues for an incredible journey. Your dedication to our patients is an inspiration, and I know your commitment to our patient-centric mission will continue to guide your work at Novocure.

我要感謝所有同事，感謝他們帶給我的這段不可思議的旅程。您對我們患者的奉獻精神是一種鼓舞，我知道您對以患者為中心的使命的承諾將繼續指導您在 Novocure 的工作。

Finally, I would like to thank our patients, their families and caregivers, physicians, and carer teams for putting your faith in us. Our mission has always been personal to me and something I take extremely seriously. There is nothing more sacred than giving someone more time with the people they love, and I will always be grateful for the opportunity to contribute to each and every patient's journey.

最後，我要感謝我們的病人、他們的家人和護理人員、醫生和護理團隊對我們的信任。我們的使命對我來說始終具有個人意義，我對此極為重視。沒有什麼比讓人們有更多的時間與他們所愛的人在一起更神聖的了，我將永遠感激有機會為每位病人的旅程做出貢獻。

Thank you. I will now hand the call back to the operator.

謝謝。我現在將把電話交還給接線員。

(Operator Instructions) Larry Beagleson, Wells Fargo.

（操作員指示） 拉里·比格森（Larry Beagleson），富國銀行。

Hi, good morning. It's [Leigh] calling in for Larry. Can you hear me okay?

嗨，早安。我是 [Leigh] 打電話給 Larry 的。你聽得到我說話嗎？

Yes.

是的。

First, a softest congratulations on your retirement. Well-deserved. As far as questions, just on LUNAR, what are you saying about the revenue per patient for Optune Lua, and as far as treatment duration, should we think about the four to five-month average? And along with that, what are you expecting on timing for Japan approval? And I have a follow-up.

首先，對您退休表示最誠摯的祝賀。當之無愧。就問題而言，僅就 LUNAR 而言，您認為 Optune Lua 的每位患者收入是多少？除此之外，您對日本批准的時間有什麼預期？我還有一個後續問題。

Leigh, this is Ashley. I'll jump in just quickly with the first question. We would expect the pricing per patient to be in line with the Optune Gio pricing, and you are right. That's the four to five months is what I would model. That's what we saw in the clinical trial, and until we have more commercial experience, that's what we would aim for you to do.

利，這是阿什利。我將很快回答第一個問題。我們希望每位患者的定價與 Optune Gio 定價一致，您是對的。這就是我要模擬的四到五個月的時間。這就是我們在臨床試驗中看到的，在我們擁有更多的商業經驗之前，這也是我們希望您做到的。

Japan, so we are in basically start our discussion with the FDA, and we are in advance with them, and we expect them to continue to report.

因此，我們基本上已開始與日本 FDA 進行討論，並且我們已提前與他們溝通，我們希望他們繼續報告。

So, sorry, was Japan also early '25?

那麼，抱歉，日本也是 25 年初嗎？

We haven't given any timelines yet, but what we'll say is that we're in productive discussions, and we'll update as soon as we have my insight.

我們尚未給出任何時間表，但我們要說的是，我們正在進行富有成效的討論，一旦我們有了了解，我們會立即更新。

Okay, got it. And thanks. And then for my follow-up, just in Q3, so your reported active patient numbers came in above our estimate across virtually all regions. The prescription numbers weren't too far off our model, so that would imply longer treatment duration in those key markets. Can you give any color there as far as what you're seeing on treatment duration, and if those are still consistent with what you saw in EF-14, if that's changed? Thanks.

好的，明白了。謝謝。然後就我的後續情況而言，僅在第三季度，您報告的活躍患者數量幾乎在所有地區都高於我們的估計。處方數量與我們的模型相差不大，這意味著在這些關鍵市場中治療時間會更長。就您所觀察到的治療持續時間而言，您能否提供任何細節，以及這些是否仍然與您在 EF-14 中看到的一致，如果有變化的話？謝謝。

Hi, this is Frank speaking. Thanks for mentioning the active patient growth across all the active markets. We're incredibly proud to have achieved over 4,000 patients on therapy for the first time.

大家好，我是弗蘭克。感謝您提及所有活躍市場的活躍患者成長情況。我們非常自豪首次實現超過 4,000 名患者接受治療。

What I'll note is something that Ashley noted in the script, which is that we are focused on the end-to-end patient journey, which includes not just focusing on duration, but also helping more patients convert from the time of prescription to a start. And so I think I wouldn't look at it in terms of just pure growth in duration and really think about it as a continuum along that process.

我要注意的是阿什利在腳本中提到的一點，那就是我們專注於端到端的患者旅程，這不僅包括關注持續時間，還包括幫助更多患者從處方時間轉變為開始時間。因此，我認為我不會只從純粹持續時間的成長的角度來看待它，而是真正地把它看作是這個過程的一個連續體。

Jason Bednar, Piper Sandler.

傑森·貝德納，派珀·桑德勒。

Hey, good morning. A lot of congrats to go around to SOP and Ashley and on the recent FDA approval. You know, first question from us is really a kind of two-parter, I guess, related to the lung approval. You mentioned some of the next steps here.

嘿，早安。非常感謝 SOP 和 Ashley 以及他們最近獲得的 FDA 批准。您知道，我們提出的第一個問題實際上是兩個部分，我想，與肺部批准有關。您在這裡提到了一些後續步驟。

You launched in the US making sure you're getting prescriptions written for patients that fit your label. I know this is going to build over time, but maybe can you help us with how you're internally thinking about the ramp of uptake in terms of treating physicians or the number of physicians you're going to be onboarding, the number of scripts or patients that maybe you might expect in the first year of your launch? Is there anything you're willing to share there?

您在美國推出產品時確保為符合您的標籤的患者開立處方。我知道這會隨著時間的推移而發展，但也許您能幫助我們了解一下，您內部是如何考慮治療醫生的增加，或者您將要招募的醫生數量，以及您在推出的第一年可能預期的處方或患者數量？您願意分享什麼嗎？

And then just -- yeah, and I don't want to get too far ahead of ourselves, but [strip] modeling $10 million in revenue from lung for 2025, is that a number that you're comfortable with or you're willing to bless today?

然後只是——是的，我不想走得太遠，但是[剝離]模型顯示2025年肺部收入為1000萬美元，這個數字是您可以接受的還是您今天願意接受的？

Yeah, Jason, this is Frank again. Thank you for the question. I'll talk just in terms of our approach to the launch. I'll reiterate some things that we've said before.

是的，傑森，我又是法蘭克。感謝您的提問。我將只談論我們發布的方式。我將重申我們之前說過的一些話。

First, actually, I'll start with saying that we're very pleased with the label, that we think we have a very broad label. It fits with how the trial is conducted and it gives us. A really good platform to engage physicians. Two is that we're anchoring the launch to the fact that there is a very high unmet medical need for patients who are in platinum failure, in metastatic platinum failure disease.

首先，實際上，我要說的是，我們對這個標籤非常滿意，我們認為我們有一個非常廣泛的標籤。它符合試驗的進行方式並為我們提供了幫助。這是一個真正吸引醫生的良好平台。二是，我們推出該產品是基於這樣一個事實：鉑類失敗患者和轉移性鉑類失敗疾病患者存在非常高的未滿足的醫療需求。

And so accordingly, what we're really focused on right now is getting our teams in the field to meet with physicians to make sure we have the right, highly motivated physicians who are interested in integrating tumor treatment fields into their practice. We really want to work on then finding the right patients for them, those patients who can succeed on the therapy.

因此，我們現在真正關注的是讓我們在該領域的團隊與醫生會面，以確保我們擁有合適的、積極的醫生，他們有興趣將腫瘤治療領域整合到他們的實踐中。我們確實希望努力為他們找到合適的患者，那些能夠成功治療的患者。

And then lastly, I think it comes down to the right time. So it's right physician, right patient, and right time. And where we always see tumor treatment fields having the best potential for a benefit is when you start as early as possible.

最後，我認為這取決於正確的時機。因此，這取決於正確的醫生、正確的病人和正確的時間。我們始終認為，腫瘤治療領域越早開始，就越有可能獲得最大的益處。

So we're trying to get the process in place with our physicians to capture patients as they move to as they see disease progression immediately. And so really the message for the coming year is right physician, right patient, right time. And I'll say that we think while we don't give specific guidance, let's say I thinkhat translates over to that focus on good execution rather than sort of a maximal revenue effort.

因此，我們正嘗試與醫生一起實施這項流程，以便在患者病情進展時立即捕捉他們的動態。因此，來年真正的訊息是正確的醫生、正確的病人、正確的時間。我想說的是，雖然我們沒有給出具體的指導，但我認為這意味著專注於良好的執行，而不是最大化的收入努力。

Okay, thanks, Frank. And maybe to dovetail off of that, as we think about the reimbursement strategy for lung, can you talk about in what ways this might be similar or different to what you established with GBM several years ago when we worked to get payer coverage for a new indication then? Do you start commercial and then go after Medicare like you did with that process? Does the timeline on getting coverage move faster knowing that you already have a reference rate with GBM and experience with the payers covering the technology?

好的，謝謝，弗蘭克。也許是為了與此相吻合，當我們考慮肺癌的報銷策略時，您能否談談這與幾年前我們為 GBM 建立的報銷策略有何相似或不同之處，當時我們努力為新適應症獲得付款人承保？您是否先從商業化開始，然後像之前一樣推行醫療保險？如果您已經擁有 GBM 的參考利率以及支付方涵蓋該技術的經驗，那麼獲得覆蓋的時間表是否會更快？

Yeah, absolutely. So let me answer the question specifically and then I'll give color, which is we've broadly anticipated it will take one to two years to achieve broad reimbursement coverage. The way that we'll achieve that will most likely go with better success first with private payers and then moving into the original Medicare fee-for-service program.

是的，絕對是如此。所以讓我具體回答這個問題，然後我會給出具體信息，我們大致預計需要一到兩年的時間才能實現廣泛的報銷覆蓋。我們實現這一目標的方式很可能是先與私人付款人合作取得更好的成功，然後轉向原始的醫療保險按服務收費計劃。

But our focus in the US is going to be on accepting patients who meet the essential, meet the label, and meet the profile of patients in the clinical trials and then begin working with the payers over the one to two years to get success. We're not going to specifically target one payer segment population on the other.

但我們在美國的重點是接受符合基本條件、符合標籤且符合臨床試驗患者特徵的患者，然後在一到兩年內開始與付款人合作以取得成功。我們不會專門針對某一付款人群體而針對另一付款人群體。

Okay, but right to think that you start commercial then go Medicare, do you need -- sorry, just to maybe follow up, do you need a certain base or size or scale of commercial before you expect Medicare to provide full coverage?

好的，但是如果您先開始商業化然後再進行醫療保險，您是否需要——抱歉，只是想跟進一下，您是否需要一定的商業基礎或規模，然後您才能期望醫療保險提供全額覆蓋？

Well, Jason, this is where I'd anchor back to the one to two years to just, I think about the total population, the total effort as something that will play out over one to two years.

好吧，傑森，這就是我將時間錨定在 1 到 2 年的時間，我認為總人口、總努力將會在 1 到 2 年內完成。

Jonathan Chang, Leerink Partners.

Jonathan Chang，Leerink Partners。

Your line is open. Hi, guys. Thanks for taking the questions. First question, on the plan transitions to the management team, can you talk about how we should be thinking about potential changes in overall company strategy? And second question, can you discuss the latest progress for the Optune's lung cancer regulatory review in Germany? And do you expect to get a similarly broad label as with the US? Thank you.

您的線路已開通。嗨，大家好。感謝您回答這些問題。第一個問題，關於向管理團隊過渡的計劃，您能談談我們應該如何考慮公司整體策略的潛在變化嗎？第二個問題，您能否討論一下Optune在德國肺癌監管審查的最新進展？您是否期望獲得與美國一樣廣泛的標籤？謝謝。

Hi, Jonathan. This is Ashley. Maybe I'll start with the first question, then hand it over to Asaf for an update on the [QED] process. So I mean, zooming out, no major has been since the beginning focused on bringing tumor-treating fields to patients with aggressive forms of cancer. That will not change.

你好，喬納森。這是阿什利。也許我會從第一個問題開始，然後將其交給 Asaf 以更新[QED] 進程。所以我的意思是，從一開始，就沒有任何專業專注於為患有惡性癌症的患者提供腫瘤治療領域。這不會改變。

And when we look at our 2024 objectives and what we need to do to deliver value looking forward, that also does not change. We need to continue to grow GBM. We need to have a successful lung lung, and then we need to deliver on our pipeline.

當我們審視 2024 年的目標以及我們需要做些什麼來實現未來價值時，這一點也沒有改變。我們需要繼續發展 GBM。我們需要擁有一個成功的肺，然後我們需要交付我們的管道。

So it's a broad stroke. I will very much be focused on making sure that we have pull-through on those strategic pillars. I'll continue to put more fine-toothed details on that, both with our internal and external messaging over the next couple of months. But I would say we know what we need to do, and we remain committed to doing it.

所以這是一個大致的概括。我將全心全意地確保我們能夠實現這些戰略支柱。在接下來的幾個月裡，我會透過內部和外部資訊繼續提供更詳細的資訊。但我想說，我們知道我們需要做什麼，而且我們仍然致力於去做。

And regarding the CMR, basically, there are no updates since last quarter, and we are waiting and anticipating that we'll see the CMR coming.

關於 CMR，基本上，自上個季度以來沒有更新，我們正在等待並期待 CMR 的到來。

Emily Bodnar, H.C. Wainwright.

艾米莉·博德納，H.C.溫賴特。

Hi. Good morning. Thanks for taking the questions, and also my congratulations as well. I'm curious about what your approach to marketing in lung is for particularly patients who've received checkpoint inhibitors in the first-line setting, and what the kind of initial feedback from physicians has been on whether they kind of see benefit in prescribing Optune to patients who are PD-1 experienced. And then, if you can provide any timing on potential data for LUNAR-2 and LUNAR-4 studies. Thank you.

你好。早安.感謝您回答問題，我也向您表示祝賀。我很好奇，您對肺癌的營銷策略是什麼，特別是針對那些一線接受檢查點抑製劑治療的患者，以及醫生的初步反饋是什麼樣的，他們是否認為為接受 PD-1 治療的患者開出 Optune 是有益的。然後，如果您能提供關於 LUNAR-2 和 LUNAR-4 研究的潛在數據的任何時間表的話。謝謝。

Hi. This is Frank again. So to talk about the strategy in terms of the launch and the engagement with physicians, I think number one, again, I'll go back to the fact that we're very pleased with the label that we've received, which does allow us to have tumor-treating fields used concurrently with an immune checkpoint inhibitor.

你好。我又是弗蘭克。因此，談到發布和與醫生互動方面的策略，我認為首先，我要再次回到這樣一個事實：我們對所獲得的標籤感到非常滿意，這確實使我們能夠同時使用腫瘤治療領域和免疫檢查點抑制劑。

And what I'll say again is that we do see in discussions with physicians is a clear recognition of an unmet need, because these are patients who are post-platinum failure, do not have a driver mutation, and, really have not seen any improvement in survival in the last eight years.

我想再次強調的是，我們在與醫生的討論中確實看到，患者清楚地認識到了未滿足的需求，因為這些患者是鉑類藥物治療失敗後的患者，沒有驅動突變，並且在過去的八年中生存率確實沒有改善。

So there's sort of a clear need to deliver better care to that patient population. I saw this personally last week as I was in the field where I had the chance to meet with someone who was an investigator in the LUNAR trial and an investigator now in our LUNAR-2 trial, and they were really working through now how do we bring tumor-treating fields into the tumor board to make sure that as our patients are noted for progression that we can put them through a screening process.

因此顯然需要為該患者群體提供更好的護理。上週我親眼目睹了這一點，當時我在實地有機會會見了一位曾參與 LUNAR 試驗的研究人員和現在參與 LUNAR-2 試驗的研究人員，他們正在研究如何將腫瘤治療領域帶入腫瘤委員會，以確保當我們的患者出現進展時，我們可以對他們進行篩選過程。

So what I say is that our initial experience has been really strong engagement with physicians, and as we get a little bit further into the launch, we would probably feel more comfortable commenting on which patients they're selecting. We're literally two weeks into this right now. So again, I just go back to the fact that what we see consistently is a recognition of a high unmet need and then an attempt to figure out the right way to bring it into practice.

所以我想說的是，我們最初的經驗是與醫生進行非常密切的接觸，隨著我們進一步推進發布，我們可能會更願意評論他們選擇哪些患者。現在我們已經進行了兩週了。所以，我再次回到這個事實：我們始終看到的是，人們認識到了尚未滿足的巨大需求，然後試圖找到正確的方法將其付諸實踐。

And, Emily, this is Nicholas. Good morning. I'll take the second part of your questions about the trials. So first of all, let me tell you that I'm incredibly proud of that FDA approval, and, of course, we are excited about that. And in terms of trials, we're recruiting in LUNAR-2 and LUNAR-4, and you can imagine, I cannot give you clear numbers, but we feel the momentum among the investigators.

艾米麗，這是尼可拉斯。早安.我將回答你關於試驗的第二部分問題。首先，我要告訴你們，我對 FDA 的批准感到無比自豪，當然，我們對此感到非常興奮。在試驗方面，我們正在 LUNAR-2 和 LUNAR-4 中招募人員，你可以想像，我無法給出明確的數字，但我們感受到了研究人員的勢頭。

Jessica Fye, JPMorgan.

摩根大通的傑西卡·菲伊 (Jessica Fye)。

Hey, guys. Good morning. Thanks for taking my questions. If PANOVA-3 pancreatic trial is successful, can you talk a bit about how we should think about when you would be ready to file for approval in the US and Europe? And then, second, you mentioned the next-gen arrays could be a headwind to gross margins in the future. Can you just give us a sense of the magnitude there?

嘿，大家好。早安.感謝您回答我的問題。如果 PANOVA-3 胰臟試驗成功，您能否談談我們應該如何考慮何時準備在美國和歐洲申請批准？其次，您提到下一代陣列可能會對未來的毛利率造成不利影響。您能讓我們大概了解一下那裡的規模嗎？

Thank you. Yeah, Jess, this is Ashley. I'll take those. So I would say I would anchor to industry norms when we think about time to go from data to approval. What we know is that it takes one to two quarters to get the package prepped, and then we expect the review time to take another 9 to 12 months. So that's what I would anchor you to for PANOVA-3 as well as all of our clinical trials. That's PANOVA.

謝謝。是的，傑西，這是阿什莉。我會接受這些。因此我想說，當我們考慮從數據到批准的時間時，我會遵循行業規範。我們知道，準備好這個方案需要一到兩個季度的時間，然後我們預計審核時間還需要 9 到 12 個月。所以這就是我對 PANOVA-3 以及我們所有臨床試驗的建議。這就是 PANOVA。

When we -- headwinds to gross margins -- thank you. I would expect gross margin, depending on where we land with net revenue per active patient, which is actually largely driven by the success of our lung cancer launch, remember, where we will be treating patients ahead of reimbursement in the first couple of quarters to remain in the 70s. And if lung is going really well, you're going to have a lower 70 number. You're going to be more towards the mid if we have less rapid uptake with lung.

當我們 - 毛利率遇到阻力時 - 謝謝。我預計毛利率將保持在 70% 左右，這取決於我們每位活躍患者的淨收入，這實際上很大程度上取決於我們肺癌治療的成功，記住，我們將在頭幾個季度提前治療患者，然後再報銷。如果肺部狀況非常好，您的數字將會低於 70。如果肺部的吸收速度較慢，那麼您將更傾向於中間狀態。

So it is actually far more dependent on the net revenue per active patient that we're able to build than it is on COGS itself. We've talked about the headwinds from COGS from the launch of our next-generation array, but those will wash through fairly quickly. Within a couple of quarters, we'll be back down to kind of a manufacturing-optimized price point there.

因此，它實際上更多地依賴我們能夠創造的每位活躍患者的淨收入，而不是 COGS 本身。我們已經討論過下一代陣列發佈時 COGS 帶來的阻力，但這些阻力很快就會消失。在幾個季度內，我們將回到製造優化的價格點。

Zooming out, I would say over the course of the next six quarters, six to eight quarters, we would expect all of that to wash out, and we'll be back to the margins we're looking at today.

從長遠來看，我想說，在接下來的六個季度、六到八個季度裡，我們預計所有這些都將消失，我們將回到今天看到的利潤率。

Vijay Kumar, Evercore ISI.

維賈伊·庫馬爾（Vijay Kumar），Evercore ISI。

Hi. This is Kevin on for Vijay. Just a question on the reimbursement pathway for lung cancer. So to follow up on Jason's point on similarities versus differences in the past, are you expecting a CMS panel this time around as well? And how should we think about some of the barriers towards reimbursement in the US? Thank you.

你好。這是 Kevin 代替 Vijay。我只是想問一下肺癌的報銷途徑。那麼，為了跟進 Jason 關於過去的相似點與不同點的觀點，您是否也期待這次有一個 CMS 面板？我們該如何看待美國報銷的一些障礙？謝謝。

Hi. Thank you for the question. This is Frank. I would say, again, I'd start with the big picture, which is that we expect the entire process of gaining reimbursement to be across both private payers and the Medicare program to play out over one to two years.

你好。感謝您的提問。這是弗蘭克。我想再次說，我將從大局開始，那就是我們預計獲得報銷的整個過程將涉及私人付款人和醫療保險計劃，並將在一到兩年內完成。

In terms of the specifics of how we will approach CMS and what steps will happen with CMS, I would add the color that we've been in dialogue with CMS, and we do have multiple different pathways to approach them to request coverage. I think it's too early for us to give comments on specifics of how that will play out.

關於我們將如何與 CMS 接洽以及 CMS 將採取哪些步驟的具體細節，我想補充一點，我們一直在與 CMS 進行對話，並且我們確實有多種不同的途徑來與他們接洽以請求覆蓋。我認為現在就事情將如何發展發表具體評論還為時過早。

And so again, I think I would think about this just in the context that it's – reimbursement is always very complex. There are multiple pathways to get to the end, and really just think about it as a one to two-year program in totality, and we'll give updates as we have more specifics.

因此，我再次認為我會從報銷總是非常複雜的角度來考慮這個問題。有多條途徑可以達到最終目標，實際上只需將其視為為期一到兩年的計劃，一旦有更多細節，我們將進行更新。

Thank you. I'm showing no further questions at this time. I'd like to turn it back to Bill Doyle for closing remarks.

謝謝。我目前沒有其他問題。我想請比爾道爾作最後發言。

So let me thank you all for your continued interest in our progress at Novocure. When we entered this year, 2024, we stated both externally and internally three clear goals. Grow GBM, deliver on the promise of our pipeline, and launch low.

因此，我感謝大家對 Novocure 進展的持續關注。當我們進入2024年的時候，我們對外和對內都提出了三個明確的目標。發展 GBM，兌現我們的管道承諾，並低價推出。

Here, as we report Q3, I'm very pleased that we've made significant and important progress on all three. We're delighted to report 22% top-line growth year over year.

在我們報告第三季時，我很高興我們在這三個方面都取得了重大而重要的進展。我們非常高興地報告，我們的營業額較去年同期成長了 22%。

We have a long list in terms of delivering on our pipeline, on our pipeline, starting with the METIS successful readout; FDA providing breakthrough designation; of course, the FDA approval of LUNAR with the broad label that we had sought; and then the LPIs, the last patients in for both TRIDENT earlier in the year and this quarter, PANOVA-4; and then initiating the important trial of Keynote CD58.

我們有一個很長的交付管道清單，首先是 METIS 的成功讀數； FDA 提供突破性認定；當然，FDA 批准了我們所尋求的具有廣泛標籤的 LUNAR；然後是 LPI，這是今年早些時候和本季接受 TRIDENT 試驗的最後幾名患者，還有 PANOVA-4；然後啟動Keynote CD58的重要審判。

That's a long list. I could make a longer list if I were to describe all the work that's being done in our preclinical and our clinical teams.

這是一個很長的清單。如果我要描述我們的臨床前和臨床團隊正在進行的所有工作，我可以列出一個更長的清單。

And then finally, from a commercial perspective, launch low. And as Frank described, we were prepared, and we launched the day after receiving FDA approval, and have received our first prescriptions. So it's been a great year and a great quarter of achievement.

最後，從商業角度來看，低端推出。正如弗蘭克所描述的，我們已經做好了準備，在獲得 FDA 批准的第二天就推出了產品，並且收到了第一批處方。因此，這是偉大的一年，也是一個取得巨大成就的季度。

I am going to end by thanking Asaf. I must admit, for me personally, it's bittersweet. He deserves retirement. He spent two years planning to position Novocure in the strong position that we're in, but I'm going to miss him. And with that, thank you very much.

最後我要向阿薩夫表示感謝。我必須承認，對我個人而言，這是苦樂參半的。他應該退休。他花了兩年的時間計劃讓 Novocure 處於我們所處的強勢地位，但我會想念他的。最後，非常感謝。

This concludes today's conference call. Thank you for participating, and you may now disconnect.

今天的電話會議到此結束。感謝您的參與，您現在可以斷開連接。