Novocure Ltd (NVCR) 2025 Q3 法說會逐字稿

Good day and thank you for standing by. Welcome to the Novocure third-quarter 2025 earnings call. (Operator Instructions)

您好，感謝您的耐心等待。歡迎參加 Novocure 2025 年第三季財報電話會議。（操作說明）

Please be advised, today's conference is being recorded.

請注意，今天的會議正在錄影。

I would now like to hand the conference over to your speaker today, Ingrid Goldberg. Please go ahead.

現在我謹將會議交給今天的演講嘉賓英格麗德‧戈德堡。請繼續。

Good morning, and thank you for joining us to review Novocure's third-quarter 2025 performance. I am on the phone this morning with our Executive Chairman, Bill Doyle; CEO, Ashley Cordova; and CFO, Christoph Brackmann. Other members of our executive leadership team will be available for Q&A.

早安，感謝各位參加本次會議，共同回顧Novocure 2025年第三季的表現。今天早上我正在和我們的執行董事長比爾·道爾、首席執行官阿什利·科爾多瓦和首席財務官克里斯托夫·布拉克曼通電話。我們高階主管團隊的其他成員也將出席問答環節。

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，本次獲利報告的配對幻燈片可在我們的網站 www.novocure.com 的「投資者關係」頁面「季度報告」下找到。

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.

在會議開始之前，我想提醒各位，本次電話會議的討論將包含前瞻性陳述，實際結果可能與這些陳述中預測的結果有重大差異。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，我們會不時在提交給美國證券交易委員會的文件中對此進行描述。除法律要求外，我們不打算公開更新任何前瞻性聲明。

Where appropriate, we will 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 best reflects the financial value generated by our business.

在適當情況下，我們將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，即利息、稅項、折舊、攤提和股份支付之前的收益指標。我們認為調整後的 EBITDA 是一個重要的指標，因為它消除了資本結構、稅率和重大非現金項目對收益的影響，並且最能反映我們業務創造的財務價值。

Reconciliations of non-GAAP financial measures are included in our press release, earnings slides, and in our Form 10-Q filed with the SEC today. These materials can also be accessed from the investor relations page of our website. Following our prepared remarks today, we will open the line for your questions.

非GAAP財務指標的調整情況已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提交的10-Q表格中。這些資料也可從我們網站的投資者關係頁面取得。今天我們發言結束後，將開放式提問環節。

I will now turn the call over to our Executive Chairman, Bill Doyle.

現在我將把電話交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 survival in some of the most aggressive forms of cancer. Through our early years, our efforts focused mostly on the treatment of patients with glioblastoma.

謝謝你，英格麗德，早安。在諾沃克醫療中心，我們的使命是延長某些最具侵襲性癌症患者的存活期。在創業初期，我們的工作主要集中在治療膠質母細胞瘤患者。

Now, with one launch ongoing and two additional launches planned for next year, the scope of our mission has expanded to reach more patients who can benefit from tumor-treating fields in multiple solid tumor cancers.

現在，隨著一項發射正在進行，以及明年計劃推出兩項新的發射，我們的使命範圍已經擴大，惠及更多能夠從腫瘤治療場中受益的多種實體腫瘤癌症患者。

As we evolve from a single indication company to a true platform therapy company, we are focused on three priorities. First, preparing to treat four cancer indications by year-end 2026. Second, reaching profitability. And third, making disciplined investments that strengthen our product portfolio in the near and the long term.

隨著我們從單一適應症公司發展成為一家真正的平台療法公司，我們專注於三個優先事項。首先，準備在 2026 年底前治療四種癌症適應症。第二，實現盈利。第三，進行有紀律的投資，以加強我們近期和長期的產品組合。

We will begin this morning with a review of our Q3 commercial results in glioblastoma and non-small cell lung cancer. We will discuss regulatory updates and preparation for anticipated launches in pancreatic cancer and brain metastases. And we will provide updates to our ongoing clinical and product development programs. We will conclude with a review of our quarterly financials and open the line for questions.

今天上午，我們將首先回顧我們在膠質母細胞瘤和非小細胞肺癌領域的第三季商業表現。我們將討論胰臟癌和腦轉移瘤的監管更新和預期上市準備。我們將及時更新我們正在進行的臨床和產品開發項目進度。最後，我們將回顧季度財務狀況，並開放提問環節。

Our GBM business remains solid, and active patients have grown between 5% and 12% year over year for the last nine consecutive quarters. We ended the third quarter with 4,277 GBM patients on therapy, our largest patient count to date. The largest contributors to active patient growth in this quarter were France, Japan, and Germany, which grew 27%, 8%, and 7% respectively.

我們的膠質母細胞瘤業務依然穩健，在過去連續九個季度中，活躍患者數量年增 5% 至 12%。第三季末，我們共有 4,277 名 GBM 患者接受治療，這是我們迄今為止患者人數最多的一次。本季活躍患者成長貢獻最大的國家是法國、日本和德國，分別成長了 27%、8% 和 7%。

We also expanded our international footprint. Last month, we received a positive national coverage decision from the Spanish Ministry of Health. At maturity, we expect Spain to deliver annual net revenue that is approximately half that of France. We expect full ramp up to take a few years, given the fragmented nature of the Spanish healthcare system. In the US, our GBM active patient count was flat compared to Q3 2024.

我們也擴大了國際商業版圖。上個月，我們收到了西班牙衛生部關於全國醫保覆蓋範圍的積極決定。我們預計，西班牙成熟後每年的淨收入將約為法國的一半。鑑於西班牙醫療保健系統的分散性，我們預計全面恢復需要幾年時間。在美國，我們的 GBM 活躍患者數量與 2024 年第三季相比持平。

While we are proud to be treating approximately 40% of GBM patients in the US, we recognize that many more patients could benefit from TTFields therapy. Unlike lung cancer and pancreatic cancer, where most patients seek treatment in community centers, virtually all GBM patients undergo brain surgery at high volume academic centers after diagnosis. Oncologists at academic centers often prioritize enrollment in pharmaceutical clinical trials over new medical device-based therapies. This dynamic limits the number of patients offered Optune Gio in academic centers, despite the established clinical benefits of TTFields therapy.

雖然我們很自豪能夠治療美國約 40% 的 GBM 患者，但我們也意​​識到，更多的患者可以從 TTFields 療法中受益。與肺癌和胰臟癌不同，肺癌和胰臟癌的大多數患者都在社區中心尋求治療，而幾乎所有 GBM 患者在確診後都會在高容量學術中心接受腦部手術。學術中心的腫瘤學家通常優先考慮藥物臨床試驗，而不是基於新型醫療器材的療法。儘管 TTFields 療法具有已證實的臨床益處，但這種動態限制了學術中心為 Optune Gio 提供治療的患者數量。

Our commercial team continues to refine its approach within this complex environment, and we remain committed to ensuring that all eligible GBM patients are offered Optune Gio therapy. Turning to non-small cell lung cancer, we've acknowledged that our launch is behind expectations, and in Q3, we did not see a continuation of the linear growth we've seen in the prior two quarters.

我們的商業團隊將繼續在這個複雜的環境中改進其方法，我們將繼續致力於確保所有符合條件的 GBM 患者都能獲得 Optune Gio 療法。就非小細胞肺癌而言，我們已經承認我們的產品上市落後於預期，並且在第三季度，我們沒有看到前兩個季度所看到的線性增長的延續。

While we anticipated lung cancer would be our most challenging indication to launch, it has been harder than we expected. We finished Q3 with 100 lung cancer patients on therapy, 94 in the US, and 6 in Germany.

雖然我們預料到肺癌將是我們最難推出的適應症，但實際情況比我們預期的還要困難。第三季末，我們共有 100 名肺癌患者接受治療，其中 94 名在美國，6 名在德國。

What makes advanced lung cancer particularly challenging is the poor overall health status of these patients, the high level of competition from new targeted drug therapies, and the limited median duration of therapy, four months versus the 10 months for newly diagnosed GBM. We experienced similar launch challenges in 2011 with our initial launch in recurrent GBM when we introduced our device-based therapy to the neuro-oncology community in an advanced cancer setting.

晚期肺癌的挑戰性尤其在於這些患者的整體健康狀況較差，面臨來自新型標靶藥物療法的激烈競爭，以及治療的中位持續時間有限（4 個月，而新診斷的 GBM 的治療中位數持續時間為 10 個月）。我們在 2011 年首次推出復發性膠質母細胞瘤 (GBM) 治療方案時也遇到了類似的挑戰，當時我們將基於設備的療法引入晚期癌症的神經腫瘤學領域。

With GBM, we learned that consistent education and follow-on data generation drives prescriber and patient adoption over time. We are anticipating a similar path in lung.

透過 GBM，我們了解到，持續的教育和後續數據產生能夠隨著時間的推移推動處方醫生和患者的接受度。我們預期肺部疾病也會發展出類似的規律。

To delve deeper, lung cancer is a highly competitive space. The survival benefit demonstrated in the LUNAR Phase III trial remains among the best reported in the post-platinum setting, but the number of systemic drug therapies available across settings makes the transition to a novel device-based modality like Optune Lua seem like a heavier lift for both physicians and patients.

更深入地說，肺癌領域競爭非常激烈。LUNAR III 期試驗所顯示的生存獲益仍然是鉑類後治療領域報道的最佳結果之一，但目前各種治療方案中可用的全身藥物療法數量眾多，使得醫生和患者向 Optune Lua 等新型基於設備的治療模式過渡似乎更加困難。

Our sales team is tackling this by highlighting specific patient profiles to help physicians better understand where Optune Lua is likely to provide the best benefit. Our primary focus is on patients who have had a durable response to a checkpoint inhibitor plus a platinum doublet and have slow progression with a maintenance checkpoint inhibitor.

我們的銷售團隊正在透過突出特定患者特徵來解決這個問題，以幫助醫生更好地了解 Optune Lua 最有可能帶來哪些好處。我們主要關注的是對檢查點抑制劑加鉑類雙藥療法有持久療效，且使用維持性檢查點抑制劑治療後病情進展緩慢的患者。

There is also the challenge of introducing a device-based therapy to a medical oncology community that has limited device experience. As mentioned, we face a similar hurdle when we introduced Optune Gio to recurrent GBM, and we know it takes time and hands-on experience for physicians to gain comfort with the device-based therapy. Simply put, a wearable device is novel in the oncology space, and as such, we are connecting experienced Optune Gio and Lua users who can share expertise and tips based upon real-world use with physicians new to the therapy to simplify the integration of Optune Lua into their practices.

此外，向醫療腫瘤學界引入基於器械的療法也是一個挑戰，因為該領域對器械的使用經驗有限。如同前面所提到的，我們在將 Optune Gio 引入復發性 GBM 時也面臨類似的障礙，我們知道醫生需要時間和實踐經驗才能熟練基於設備的療法。簡而言之，穿戴式裝置在腫瘤學領域是全新的，因此，我們將經驗豐富的 Optune Gio 和 Lua 使用者與初次接觸該療法的醫生聯繫起來，讓他們分享基於實際使用經驗的專業知識和技巧，以簡化 Optune Lua 融入他們實踐的過程。

Looking to the near-term future, an important upcoming milestone for Optune Lua is our Japan launch. Last month, we received approval from Japanese regulators for the use of Optune Lua and checkpoint inhibitors in advanced or recurrent non-small cell lung cancer. Japan has been a consistently strong region for Novocure, and we are planning for strong physician adoption of Optune Lua.

展望近期未來，Optune Lua 即將迎來的一個重要里程碑是在日本的發布。上個月，我們獲得了日本監管機構的批准，可以將 Optune Lua 和檢查點抑制劑用於治療晚期或復發性非小細胞肺癌。日本一直是 Novocure 的重要市場，我們計劃讓 Optune Lua 在醫生群體中廣泛使用。

We believe a high prevalence of lung cancer, Japanese physicians' appreciation for device-based therapies, and a local standard of care which frequently utilizes immune checkpoint inhibitors in the first and second lines provides the conditions for a successful launch in Japan. We will be closely monitoring the dynamics of our Japan launch to inform future strategies.

我們認為，肺癌的高發生率、日本醫生對基於器械的療法的重視，以及當地一線和二線治療中經常使用免疫檢查點抑製劑的標準治療，為在日本成功推出該產品提供了條件。我們將密切關注日本市場啟動的動態，以指導未來的策略制定。

Longer term, we are working on two core programs to reach more non-small cell lung cancer patients: LUNAR-2 and product development. LUNAR-2 is our Phase III trial studying the use of Optune Lua plus checkpoint inhibitors and platinum-based chemo as a first-line treatment for newly diagnosed non-small-cell lung cancer.

從長遠來看，我們正在進行兩項核心計劃，以惠及更多非小細胞肺癌患者：LUNAR-2 和產品開發。LUNAR-2 是我們的 III 期試驗，研究 Optune Lua 加檢查點抑制劑和鉑類化療作為新診斷的非小細胞肺癌一線治療方案的應用。

Assuming success, LUNAR-2 will allow us to treat first-line lung cancer patients with Optune Lua and a checkpoint inhibitor, the drug-device combination demonstrating the best efficacy across indications.

如果成功，LUNAR-2 將使我們能夠使用 Optune Lua 和檢查點抑制劑治療一線肺癌患者，這種藥物-器械組合在各種適應症中都表現出最佳療效。

Our product development efforts are focused on making the Optune device easier for patients to use through near-term improvements in support services, software, and array design, and longer-term efforts to design a transformative next-generation device.

我們的產品開發工作重點是透過近期改進支援服務、軟體和陣列設計，使 Optune 設備更容易被患者使用；並透過長期努力設計具有變革意義的下一代設備。

It is critical to underline. We believe our efforts in lung are worth it. The investments we are making for the lung cancer indication also pave the way for our anticipated launches in pancreatic cancer and brain metastases in the next 12 months.

這一點必須強調。我們相信我們在肺部疾病方面的努力是值得的。我們在肺癌適應症方面的投資也為我們未來 12 個月內預期推出的胰臟癌和腦轉移瘤藥物鋪平了道路。

In summary, our core GBM business continues to grow, reaching more patients in more regions. Our lung cancer launch has been more difficult than anticipated, and we are learning and adapting our tactics. We have two additional launches in cancer indications with extremely high unmet needs anticipated in 2026, where minimal therapeutic options are currently available, and that we can access with limited incremental investment as our lung cancer and GBM infrastructures will be leveraged.

總而言之，我們的核心 GBM 業務持續成長，惠及更多地區的更多患者。我們的肺癌疫苗上市比預期的要困難得多，我們正在學習並調整策略。我們預計在 2026 年推出兩項針對癌症適應症的新療法，這些適應症目前存在極高的未滿足需求，治療選擇非常有限，而且我們可以利用我們在肺癌和膠質母細胞瘤領域的基礎設施，以有限的增量投資獲得這些療法。

We are confident in our strategic direction, the strength of the clinical data supporting the use of TTFields therapy, and our plans to achieve profitability.

我們對我們的策略方向、支持使用 TTFields 療法的臨床數據的力量以及我們實現盈利的計劃充滿信心。

With that, I'll turn to Ashley to provide an update on our regulatory and clinical progress.

接下來，我將請 Ashley 為我們報告我們在監管和臨床方面的進展。

Thank you, Bill. Earlier this year, we had an exciting presence at the ASCO annual meeting, where data from PANOVA-3 were presented during the Saturday evening plenary with concurrent publication in the Journal of Clinical Oncology.

謝謝你，比爾。今年早些時候，我們在 ASCO 年會上取得了令人矚目的成就，PANOVA-3 的數據在周六晚上的全體會議上進行了展示，並同時在《臨床腫瘤學雜誌》上發表。

In July, the PANOVA-3 results earned a second podium presentation at ESMO GI, where the quality of life data was described in greater detail. PANOVA-3 demonstrated tumor-treating fields' ability to extend survival and preserve quality of life in pancreatic cancer, yet another aggressive solid tumor where tumor-treating fields has shown a benefit.

7 月，PANOVA-3 研究結果在 ESMO GI 會議上進行了第二次公開演講，會上更詳細地描述了生活品質數據。PANOVA-3 證明了腫瘤電場療法能夠延長胰腺癌患者的生存期並保持其生活質量，胰腺癌是另一種侵襲性實體瘤，腫瘤電場療法已證明對胰腺癌有益。

In August, we submitted our PANOVA-3 data in a TMA package to the FDA for the treatment of unreflectable, locally advanced pancreatic cancer. The filing was accepted, and we are currently in the substantive review phase, with our FDA 100-day meeting scheduled for mid-December. The review is proceeding as anticipated, and in line with our previous experience, we expect FDA approval mid next year.

8 月，我們向 FDA 提交了 PANOVA-3 數據 TMA 包，用於治療無法反射的局部晚期胰腺癌。該申請已被受理，我們目前正處於實質審查階段，FDA 100 天會議定於 12 月中旬舉行。審查工作正如預期進行，根據我們以往的經驗，我們預計FDA將於明年年中批准該申請。

In September, we also initiated the PANOVA-3 filing process with European regulators and are currently preparing our filing in Japan. The pancreatic cancer treatment landscape is similar to GBM, where effective therapeutic options are extremely limited.

9 月，我們也啟動了向歐洲監管機構提交 PANOVA-3 申請的流程，目前正在準備在日本提交申請。胰臟癌的治療現況與膠質母細胞瘤類似，有效的治療選擇極為有限。

Feedback from leading pancreatic cancer physicians and advocacy groups on the PANOVA-3 data has been consistently positive, and we look forward to the opportunity to treat pancreatic cancer patients as soon as possible.

來自胰腺癌頂尖醫生和倡導團體的回饋對 PANOVA-3 數據一直持積極態度，我們期待盡快有機會治療胰腺癌患者。

Moving to brain metastases, we presented the final data from our Phase III METIS trials in the plenary session at the 2025 ASTRO Annual Meeting in September, and these data were concurrently published in the Red Journal, the leading publication of the radiation oncology community.

關於腦轉移瘤，我們在 2025 年 9 月舉行的 ASTRO 年會全體會議上公佈了 III 期 METIS 試驗的最終數據，這些數據也同時發表在放射腫瘤學界的權威期刊《紅皮書》上。

ASTRO is an important conference for Novocure, as it hosts the largest gathering of radiation oncologists annually, a group of physicians that historically have best appreciated the benefits of tumor-treating field therapy.

ASTRO 對 Novocure 來說是一個重要的會議，因為它每年都會舉辦規模最大的放射腫瘤學家聚會，而放射腫瘤學家群體歷來最能體會到腫瘤治療場療法的益處。

This year, the METIS presentation was one of only five plenary selections out of 2,500 submitted abstracts, underlying the community's interest in our METIS data. There is a palpable excitement among radiation oncologists in the potential of tumor-treating fields to better control brain metastases, given their experience using Optune Gio to treat GBM. The first two modules of the brain metastases PMA have been submitted to the FDA. We received questions from the FDA regarding our second module, and we are working to close these questions out swiftly.

今年，METIS 的報告是從 2500 份提交的摘要中僅有的 5 個全體會議入選報告之一，這凸顯了社區對我們 METIS 數據的興趣。鑑於放射腫瘤科醫師在使用 Optune Gio 治療膠質母細胞瘤的經驗，他們對腫瘤電場治療在更好地控制腦轉移方面的潛力感到非常興奮。腦轉移瘤 PMA 的前兩個模組已提交給 FDA。我們收到了美國食品藥物管理局 (FDA) 對我們第二個模組的詢問，我們正在努力盡快解決這些問題。

We are prepared to file the third and final clinical module as soon as those questions are resolved. Our timeline for the full PMA submission is unchanged, and we continue to expect to complete the filing by year-end 2025. Like the pancreatic cancer filing, we expect a 9 to 12-month review once the clinical module is accepted by the FDA, with the final decision anticipated in the second half of 2026.

一旦這些問題得到解決，我們將立即提交第三個也是最後一個臨床模組。我們提交 PMA 申請的時間表保持不變，我們仍然預計在 2025 年底前完成申請。與胰臟癌申請一樣，我們預計一旦臨床模組被 FDA 接受，審查將持續 9 到 12 個月，最終決定預計將在 2026 年下半年做出。

As Bill discussed, the investments in our lung launch have established the infrastructure needed to launch both the pancreatic cancer and brain metastases indications upon regulatory approval. We expect to launch these two new indications by leveraging our existing sales forces. The team detailing GBM will detail brain metastases, and the lung sales force will detail our pancreatic cancer indications.

正如比爾所討論的，我們在肺癌治療方面的投資已經建立了必要的基礎設施，一旦獲得監管部門的批准，就可以推出胰腺癌和腦轉移瘤的治療方案。我們計劃利用現有的銷售團隊推出這兩種新的適應症。負責介紹膠質母細胞瘤的團隊將詳細介紹腦轉移瘤，而負責肺癌的銷售團隊將詳細介紹我們的胰臟癌適應症。

We also see significant opportunities to leverage our medical education efforts, creating synergies across tumor types that accelerate awareness and deepen engagement within the medical oncology community. We expect our existing infrastructure to provide a strong foundation for these new indication launches without the need for substantial additional investment.

我們也看到了利用醫學教育工作取得重大進展的機會，在不同類型的腫瘤之間創造協同效應，從而提高醫學腫瘤學界的認識並加深參與。我們預計現有的基礎設施將為這些新適應症的推出提供堅實的基礎，而無需大量的額外投資。

Turning to product development, an enduring reality of virtually all cancer therapies is a tradeoff between extending survival and the burdens and side effects of receiving cancer care. An overarching goal of our product engineering efforts is to minimize any potential burden of the Optune user's experience, either through improved devices or complementary offerings.

就產品開發而言，幾乎所有癌症療法都面臨著一個長期存在的現實：需要在延長生存期和接受癌症治療的負擔和副作用之間做出權衡。我們產品工程工作的總體目標是透過改進設備或提供補充產品，最大限度地減少 Optune 使用者體驗中可能出現的任何負擔。

We are pursuing projects to improve the therapy experience for cancer patients and physicians across all indications and expect to improve the Optune experience.

我們正在推進一些項目，旨在改善所有適應症的癌症患者和醫生的治療體驗，並期望改善 Opt​​une 的體驗。

(technical difficulty)

（技術難題）

(Operator Instructions)

（操作說明）

You're back online. You can resume.

您已恢復線上。您可以繼續。

All right. I am going to pick up at the product development conversation. Okay. Welcome back, everyone. Turning to product development, an enduring reality of virtually all cancer therapies is a tradeoff between extending survival and the burdens and side effects of receiving cancer care.

好的。我打算繼續討論產品開發方面的議題。好的。歡迎大家回來。就產品開發而言，幾乎所有癌症療法都面臨著一個長期存在的現實：需要在延長生存期和接受癌症治療的負擔和副作用之間做出權衡。

An overarching goal of our product engineering efforts is to minimize any potential burden of the Optune user's experience, either through improved devices or complementary offerings. We are pursuing projects to improve the therapy experience for cancer patients and physicians across all indications, and expect to improve the Optune experience in both the near and longer term.

我們產品工程工作的總體目標是透過改進設備或提供補充產品，最大限度地減少 Optune 使用者體驗中可能出現的任何負擔。我們正在推進旨在改善所有適應症的癌症患者和醫生治療體驗的項目，並期望在近期和長期內改善 Opt​​une 的體驗。

Earlier this year, we launched a new patient app in the US which provides patients and caregivers a central location to track their Optune Gio usage, reorder new supplies, access FAQs, and contact Novocure. Over 78% of US GBM patients are users of the new app, and we are now preparing to launch in our international markets.

今年早些時候，我們在美國推出了一款新的患者應用程序，為患者和照護者提供了一個集中追蹤 Optune Gio 使用情況、重新訂購新耗材、訪問常見問題解答以及聯繫 Novocure 的平台。超過 78% 的美國 GBM 患者是這款新應用程式的用戶，我們現在正準備在國際市場上推出該應用程式。

On the physician front, we launched a new portal for GBM prescribers this year which streamlines the prescription administration and ongoing care processes. Over 60% of our target sites are active on the portal, and physicians and their care teams tell us that they are pleased with the simplified administrative processes.

在醫生方面，我們今年推出了一個新的 GBM 處方醫生入口網站，簡化了處方管理和持續護理流程。超過 60% 的目標網站已在入口網站上活躍，醫生及其護理團隊告訴我們，他們對簡化的管理流程感到滿意。

We also recently submitted our updated Maxpoint GBM treatment planning software for use with the HFE arrays to the FDA and expect approval in upcoming months. As a reminder, the Maxpoint algorithm uses patient MRI scans and physician inputs to create individualized, optimized array placement maps as a function of the electrical properties of a patient's brain tissue. Maxpoint received a Category 3 [CPP] code in July, and we plan to launch it as a product enhancement subsequent to FDA approval.

我們最近也向 FDA 提交了更新的 Maxpoint GBM 治療計劃軟體，該軟體可與 HFE 陣列配合使用，預計將在未來幾個月內獲得批准。提醒一下，Maxpoint 演算法利用患者的 MRI 掃描和醫生的輸入，根據患者腦組織的電特性，創建個人化的、優化的陣列放置圖。Maxpoint 於 7 月獲得了 3 類 [CPP] 代碼，我們計劃在獲得 FDA 批准後將其作為產品增強功能推出。

On the array front, we have rolled out our HFE arrays in all material markets and expect to fully complete the global rollout by year end. We are also in the process of bringing many of the HFE array design elements and materials components into our next generation torso array, which we expect to submit to the FDA for approval next year.

在陣列方面，我們已經在所有材料市場推出了 HFE 陣列，並預計在年底前全面完成全球推廣。我們目前也在將許多 HFE 陣列設計元素和材料組件引入我們的下一代軀幹陣列中，我們預計明年將向 FDA 提交批准。

As a med tech company, we have the unique opportunity to increase adoption and advanced patient outcomes for both product and clinical development. Of note, we have two clinical readouts expected in the first half of next year.

作為一家醫療技術公司，我們擁有獨特的機遇，可以透過產品和臨床開發來提高產品的普及率並改善患者的治療效果。值得注意的是，我們預計在明年上半年公佈兩項臨床研究結果。

The Phase II PANOVA-4 trial in metastatic pancreatic cancer should report out in Q1 of next year. And the Phase III TRIDENT results in GBM will follow in Q2. PANOVA-4 will add to the existing pool of data exploring tumor treating fields plus an immunotherapy chemo combination regimen, but for the first time in metastatic pancreatic cancer, which continues to be a devastating diagnosis for patients and their families.

針對轉移性胰臟癌的 II 期 PANOVA-4 試驗結果預計將於明年第一季公佈。TRIDENT III 期臨床試驗在 GBM 治療的結果將於第二季公佈。PANOVA-4 將為探索腫瘤治療場加免疫療法化療聯合方案的現有數據池增添新內容，但這是首次在轉移性胰腺癌中進行研究，這種疾病對患者及其家人來說仍然是一個毀滅性的診斷。

TRIDENT studies the benefit of starting tumor treating fields concurrently with chemo radiation in newly diagnosed GBM, rather than waiting until after a patient's chemo radiation cycle ends. The goal of TRIDENT is to prove tumor treating fields' ability to enhance the cancer cell DNA damage mechanisms of radiation.

TRIDENT 研究了在新診斷的 GBM 患者中，同時進行腫瘤電場治療和放射化療的益處，而不是等到患者的放射化療週期結束後再進行治療。TRIDENT 的目標是證明腫瘤電場治療能夠增強輻射對癌細胞 DNA 的損傷機制。

If successful, TRIDENT could enable radiation oncologists to prescribe tumor treating fields earlier in a GBM patient's therapy journey than a standard of care today, something we know to be important. Data from these trials will further elucidate how tumor treating fields can best be harnessed to improve the lives of patients diagnosed with these deadly cancers. And we are excited to share these results with you early next year.

如果成功，TRIDENT 可以讓放射腫瘤科醫師在 GBM 患者的治療過程中比目前的標準治療更早使用腫瘤治療場，我們知道這非常重要。這些試驗的數據將進一步闡明如何最好地利用腫瘤電場來改善被診斷出患有這些致命癌症的患者的生活。我們很高興能在明年初與您分享這些結果。

As we look ahead to 2026, we are on the verge of becoming a true platform therapy company. With four indications expected in market by year-end 2026, our teams are excited about the opportunity to treat many more patients in need and continue our pursuit of profitability in the year to follow.

展望 2026 年，我們即將成為一家真正的平台療法公司。預計到 2026 年底將有四項適應症上市，我們的團隊對有機會治療更多有需要的患者感到興奮，並期待在接下來的一年中繼續追求盈利。

I'll now turn the call over to Christoph to review our Q3 financial performance.

現在我將把電話交給克里斯托夫，讓他回顧我們第三季的財務表現。

Thank you, Ashley. We continued our positive momentum this quarter with net revenues of $167 million, an increase of 8% from the third quarter last year. This was primarily driven by year-over-year active patient growth of 5% in our GBM franchise, notably by strong performance in France, Germany, and Japan. We also had a foreign exchange rate tailwind this quarter of $3.3 million compared to the same period in 2024.

謝謝你，艾許莉。本季我們延續了良好的發展勢頭，淨收入達到 1.67 億美元，比去年第三季成長了 8%。這主要得益於我們 GBM 產品線的活躍患者數量年增 5%，尤其是在法國、德國和日本的強勁表現。本季我們也受惠於外匯匯率的利多，與 2024 年同期相比，增幅達 330 萬美元。

We collected $3.1 million from Optune Lua claims in the quarter, including $1.6 million from non-small cell lung cancer collections in the period. As a reminder, reported revenues from non-small cell lung cancer reflect cash collections from approvals and positive outcomes from appeals in the quarter.

本季我們從 Optune Lua 索賠中收回了 310 萬美元，其中包括本季從非小細胞肺癌索賠中收回的 160 萬美元。需要提醒的是，非小細胞肺癌的報告收入反映了本季從審批和上訴中獲得的現金收入。

Gross margin for the third quarter was 73%. The reduction in margin is reflective of the global rollout of HFE arrays, the ongoing launch in non-small cell lung cancer where we are treating patients prior to establishing reimbursement, and increased tariffs. In the quarter, we also recognized a $2.9 million expense related to an inventory obsolescence provision for Optune Lua arrays.

第三季毛利率為73%。利潤率下降反映了 HFE 陣列的全球推廣、在非小細胞肺癌領域持續進行的治療（在建立報銷機制之前，我們正在為患者提供治療）以及關稅上漲。本季度，我們也確認了與 Optune Lua 陣列的庫存過時準備金相關的 290 萬美元支出。

Moving to operating expenses. Our research and development costs in the quarter were $54 million, an increase of 4% from the same period last year. We do not expect R&D expenses to increase materially this year, as we ramped down spend on PANOVA-3 and METIS and reallocate those funds to KEYNOTE D58, and LUNAR-2.

接下來是營運費用。本季我們的研發費用為 5,400 萬美元，比去年同期成長 4%。我們預計今年的研發費用不會大幅增加，因為我們已經減少了 PANOVA-3 和 METIS 的支出，並將這些資金重新分配給了 KEYNOTE D58 和 LUNAR-2。

Sales and marketing expenses in the quarter were $59 million, a decrease of 2% from Q2 of last year. This decrease was driven by lower share-based compensation expenses. As disclosed in prior quarters, we expect to leverage our current sales force to launch our pancreatic cancer and brain metastases offerings in 2026, pending FDA approval.

本季銷售和行銷費用為 5,900 萬美元，比去年第二季減少了 2%。這一降幅主要歸因於股權激勵費用的降低。正如前幾季所揭露的，我們預計將利用我們現有的銷售團隊，在獲得 FDA 批准後，於 2026 年推出我們的胰臟癌和腦轉移產品。

SG&A expenses for the quarter were $46 million, an increase of 15% from Q3 of 2024. This increase was primarily driven by higher share-based compensation expenses and higher personnel and professional service expenses to support the greater company build-out, particularly in enterprise technology as we invest in our digital infrastructure to enable scale.

本季銷售、一般及行政費用為 4,600 萬美元，較 2024 年第三季成長 15%。這一成長主要是由於股權激勵支出增加以及為支持公司規模擴張而增加的人員和專業服務支出，尤其是在企業技術領域，因為我們投資於數位基礎設施以實現規模化。

Net loss for the quarter was $37 million, with a loss per share of $0.33. Adjusted EBITDA in the quarter was negative $3 million.

本季淨虧損為 3,700 萬美元，每股虧損 0.33 美元。本季調整後 EBITDA 為負 300 萬美元。

While still negative for now, adjusted EBITDA is currently ahead of our internal plans for the year, driven both by solid revenues from our GBM franchise, as well as constant prioritization of investments. We are committed to breaking even sustainably on an adjusted EBITDA basis in 2027 with a revenue contribution from new indications.

儘管目前調整後的 EBITDA 仍為負值，但目前已超過我們今年的內部計劃，這既得益於 GBM 業務的穩健收入，也得益於我們不斷優先考慮的投資。我們致力於在 2027 年實現經調整 EBITDA 基礎上的可持續​​盈虧平衡，並依靠新適應症的收入貢獻。

Our cash and investment balance at the end of Q3 was $1.034 billion. As a reminder, we have a $561 million in convertible notes that will come due in the coming days, which we will retire with cash from the balance sheet.

截至第三季末，我們的現金和投資餘額為 10.34 億美元。提醒各位，我們有 5.61 億美元的可轉換債券將在未來幾天到期，我們將用資產負債表上的現金償還這些債券。

We also closed on the second $100 million tranche of our credit facility this quarter. With the cash and short-term investments currently on the balance sheet and funds available through our credit facility, coupled with ongoing expense management, we continue to believe that we have the capital necessary to bridge to our next revenue streams in new indications.

本季我們也完成了第二筆1億美元信貸額度的發放。憑藉資產負債表上的現金和短期投資以及透過信貸安排獲得的資金，再加上持續的費用管理，我們仍然相信我們擁有必要的資本，可以過渡到我們在新適應症方面的下一個收入來源。

At Novocure, we are on the cusp of expanding the reach of tumor-treating fields to patients in multiple solid tumor cancers. The discerning investments we are making today establish an infrastructure capable of treating patients in multiple indications.

在 Novocure，我們即將把腫瘤治療電場的應用範圍擴大到多種實體腫瘤患者。我們今天進行的明智投資，旨在建立一個能夠治療多種適應症患者的基礎設施。

We look forward to the future, treating more commercial patients in established and new geographies, two important data releases in the first half of 2026, and pending approvals in additional indications with high unmet needs. And importantly, we are confident in our ability to achieve profitability.

我們展望未來，在成熟市場和新興市場為更多商業患者提供治療，在 2026 年上半年發布兩項重要數據，並等待在其他具有高度未滿足需求的適應症中獲得批准。更重要的是，我們對實現獲利的能力充滿信心。

We will now open the lines for questions. Operator?

現在我們將開放提問通道。操作員？

(Operator Instructions)

（操作說明）

Jason Bednar, Piper Sandler.

傑森·貝德納，派珀·桑德勒。

Good morning. Thanks for taking the questions. I wanted to start first here on a few questions here. I'm just going to pack in. The launch in Germany and Japan, I know it's super early days, but any comparisons you can make relative to the launch trajectory you have here in the US, as we think about how those markets could scale relative to how the US has performed, anything that you can take with the slower ramp and adjust to go to market strategy outside the US?

早安.謝謝您回答問題。我想先從這裡幾個問題開始。我打算收拾東西走了。在德國和日本的上市，我知道現在還處於非常早期的階段，但您能否將德國和日本的上市軌跡與美國這邊的上市軌跡進行比較？當我們考慮這些市場相對於美國市場的表現如何時，您是否可以從美國市場較慢的成長速度中汲取經驗，並調整其在美國以外地區的市場進入策略？

And then I'm wondering if there are other factors outside of just physician education that might be helpful here in the US, such as securing reimbursement and or inclusion and NCCN guidelines. Can you help me with where you stand on those fronts?

然後，我想知道除了醫生教育之外，在美國是否還有其他因素可能會有所幫助，例如獲得報銷和/或納入 NCCN 指南。您能告訴我您在這些方面持什麼立場嗎？

Great, Jason. This is Ashley. I'll start and talk a little about our market strategy. Actually, I'll start and talk a little about the global footprint, and then I'll ask Frank to jump in with the specifics in the US. I think really in Germany, what I would say is it's still very early days. We're just now entering into the beginning of our third quarter there, and the summer periods in Europe are a thing.

太好了，傑森。這是艾許莉。我先來簡單談談我們的市場策略。實際上，我會先簡單談談全球佈局，然後請弗蘭克具體談談美國的情況。我認為在德國，現在還處於非常早期的階段。我們現在正進入第三季的開始階段，而歐洲的夏天是不可避免的。

So as we look ahead, I would say there is no new news coming out of Germany that we've seen that kind of differs from the dynamics we've seen in the US, both in the opportunities to continue to drive growth and in some of the challenges that may come in this education. But I would not point to anything specific in those early numbers and say it's early days and our teams are there executing and building those relationships.

所以展望未來，我認為德國方面並沒有出現任何與我們在美國看到的動態不同的新消息，無論是在繼續推動成長的機會方面，還是在教育領域可能面臨的一些挑戰方面。但我不會根據這些早期數據指出任何具體的事情，現在還處於早期階段，我們的團隊正在執行任務並建立這些關係。

When we look ahead to Japan, we do think that this is a very different market for Optune Lua. We have received approval for Optune Lua in Japan, but we have not yet received national reimbursement. That means our field teams are able to begin the physician education process, but the real launch dynamics will come to bear when we do have physician reimbursement, which we anticipate in upcoming quarters.

展望日本市場，我們認為對於 Optune Lua 而言，這是一個非常不同的市場。我們已獲得日本對 Optune Lua 的批准，但尚未獲得國家報銷。這意味著我們的現場團隊可以開始對醫生進行教育，但真正的啟動動力將在醫生獲得報銷後顯現，我們預計這將在接下來的幾個季度實現。

But it is a market we believe will be different for us and an easier market to launch in for a couple of factors that Bill mentioned on the script. The first of which is that there is just a much higher prevalence of lung cancer in Japan.

但我們相信，對我們來說，這將是一個不同的市場，而且由於比爾在劇本中提到的幾個因素，我們將更容易進入這個市場。首先，日本肺癌的發生率要高得多。

The second of which is that Japanese physicians are more comfortable using device-based therapies, I would say, across the board. The third of which is that we have a local standard of care, which is extremely comfortable using ICI across all settings, both first and second line.

第二點是，我認為，日本醫生普遍更傾向於使用器械輔助療法。第三點是，我們有本地的護理標準，在所有情況下（包括一線和二線）都非常樂意使用 ICI。

On the top-line growth format, because we have a single national payer, once we get reimbursement, we are able to see that after patient growth translate to top line and bottomline growth quite quickly. We are preparing for that launch, and again, we are quite hopeful that it will be materially different than the trajectory we have seen in the US and Germany.

從營收成長的角度來看，因為我們只有一個全國性的支付方，一旦我們獲得報銷，我們就可以看到患者數量的成長很快就能轉化為營收和利潤的成長。我們正在為這次發射做準備，而且我們非常希望它能與我們在美國和德國看到的軌跡有實質性的不同。

Hi, Jason. This is Frank. Thank you for the question. To pivot back to the US and talk about learnings and tactics, I think one thing we would acknowledge is in the launch, we initially pursued large-volume academic practices where you do see large populations of stage 4 non-small cell lung cancer being treated. Because obviously you are trying to go after the patient volumes that you can capture. The challenge that we found in that setting is that, number one, they are just not comfortable with devices as a starting point.

嗨，傑森。這是弗蘭克。謝謝你的提問。回到美國，談談經驗教訓和策略，我認為我們應該承認的一點是，在計畫啟動之初，我們最初追求的是大規模的學術實踐，在那裡，你會看到大量的 4 期非小細胞肺癌患者正在接受治療。很顯然，你是想盡可能多地獲取患者數量。我們在這種環境下發現的挑戰是，首先，他們一開始就不習慣使用電子設備。

So you are introducing a new workflow, a new modality into the practice. What we have found more effective as we pivot is in those larger-volume practices, you can find the doctor who perhaps isn't seeing stage III but occasionally is consulted on stage 4 and is hyper-interested in tumor-treating fields.

所以你是在實務上引入一種新的工作流程、一種新的模式。我們發現，在那些病例量較大的診所中，更有效的做法是，你可以找到一些醫生，他們可能不接診 III 期病例，但偶爾會參與 4 期病例的會診，並且對腫瘤治療領域非常感興趣。

We do have an example of one large academic practice where, starting with somebody who is seeing one or two patients a month, they are now consistently prescribing three or four patients a month because they are pulling them in from the med [onc] practice.

我們確實有一個大型學術實踐的例子，一開始某個醫生每月只看一兩個病人，現在他每月穩定地給三四個病人開處方，因為他把病人從內科（腫瘤科）實踐中拉了過來。

We are trying to lean into that tactic right now of not necessarily finding the doctor with the highest volume, but finding the highest interest in their willingness to be an advocate within their practice to pull it in. Thank you, and I'm happy to provide more color.

我們現在正努力採用這種策略，不一定是尋找業務量最大的醫生，而是尋找那些最有興趣在診所內積極倡導並爭取業務的醫生。謝謝，我很樂意提供更多細節。

Maybe just as a quick follow-up, anything on commercial reimbursement to get updated on, anything on NCCN guidelines that we should be monitoring, and then as a follow-up. It's been pivoting hard, but in Spain, I know you referenced that as a market that has a different structure to it. It's going to take maybe a little bit longer than France to ramp up.

或許可以快速跟進一下，關於商業報銷方面有什麼需要更新的資訊嗎？關於NCCN指南，我們該關注哪些方面？然後作為後續跟進。它一直在努力轉型，但我知道你提到過西班牙市場，認為它的結構有所不同。可能需要比法國稍長一些的時間才能全面啟動。

I think probably it will be a bit more normal or comparable to Japan back in the day. But I guess with the trajectory of that adoption, is that something we should expect to be linear, or is it more back-end loaded, how to think about that ramp-up when it starts happening?

我認為情況可能會比較正常一些，或者說會和以前的日本差不多。但我想，就這種採用趨勢而言，我們應該預期它是線性發展的，還是後勁更足？當這種成長開始出現時，我們應該如何看待這種成長過程？

Yes, so Jason, this is Ashley. On the NCCN guidelines, just as a reminder, we submitted at the end of last year. We know that the package in the application was reviewed in early July, and we would expect the updated guidelines to be published in the upcoming months. We really don't have any more insight on the progress there beyond that. I will note that in the commercial setting, which is where we're now able to submit for reimbursement and approval, we are seeing, honestly, approval rates above our internal expectations. So this is going well.

是的，傑森，這位是艾許莉。提醒一下，關於 NCCN 指南，我們已在去年年底提交。我們知道申請資料包已於 7 月初進行審核，預計更新後的指南將在未來幾個月內發布。除此之外，我們對那裡的進展真的沒有更多了解了。我注意到，在商業環境中（我們現在可以提交報銷申請並獲得批准），坦白說，我們看到的批准率高於我們內部的預期。一切進展順利。

In lung, the payers are responding to the strength of the data. We would expect that to continue to be the case in all scenarios. I think the real unlock on the reimbursement side for lung will be Medicare, of which NCCN guidelines is a key input, but it's not the end of that journey. So I think commercial reimbursement going well, Medicare in a much longer journey, which we started and which NCCN guidelines will support.

在肺癌領域，支付方正在根據數據的優勢做出反應。我們預計這種情況在所有情況下都會繼續發生。我認為，在肺癌治療的報銷方面，真正的突破將在於醫療保險，而 NCCN 指南是其中的關鍵因素，但這並不是最終的解決之道。所以我認為商業保險報銷進展順利，而醫療保險的報銷之路則漫長得多，我們已經開始了這項工作，NCCN 指南將為此提供支援。

In Spain, I think it is a good reference to the Japan rollout of Optune Geo seven years ago, because we do have to contract hospital by hospital, despite the national reimbursement. So, it really is, I would say, in an administrative processing phase.

我認為，西班牙的情況可以很好地借鑒七年前日本推廣 Optune Geo 的經驗，因為儘管有國家報銷，我們仍然需要與醫院逐一簽約。所以，我認為，它目前確實處於行政處理階段。

Time will tell. What we said is that we think it won't flip on overnight, but it will ramp up over the course of a couple of years, and I think it will be a continuing driver of top-line growth for us, both in the active patient numbers and the revenues over the next two years.

時間會證明一切。我們說過，我們認為它不會一夜之間啟動，但會在幾年內逐步啟動，而且我認為它將成為我們未來兩年活躍患者數量和收入持續增長的驅動力。

Vijay Kumar, Evercore ISI.

Vijay Kumar，Evercore ISI。

Hi. This is Kevin on for Vijay. I have a few more questions on lung. You've talked about the launch being behind expectations. Are you able to share what your initial expectations or targets were for lung? And second, on LUNAR-4, would you say this determination is at all connected to your latest views on the lung cancer market broadly? And lastly, if you can share the year-to-date spend on that program before it was terminated. Thank you.

你好。這是凱文替維傑上場。關於肺部，我還有幾個問題。您曾提到產品發布未達預期。您能否分享一下您最初對肺部疾病的預期或目標是什麼？其次，關於 LUNAR-4，您認為這一結論是否與您最近對肺癌市場的整體看法有關？最後，如果您能分享一下該專案終止前年初至今的支出情況就更好了。謝謝。

Yeah, Kevin, this is Ashley. Thanks for the question. Unfortunately, the answer to all of those is I would say no, meaning we're not able to share that level of detail, and we're not sharing the internal launch expectations.

是的，凱文，這是艾許莉。謝謝你的提問。很遺憾，所有這些問題的答案都是否定的，這意味著我們無法分享如此詳細的信息，也不會透露內部發布預期。

What I will say, though, what we can say is that we always knew that this would be a slower ramp than it would be if we were a little white pill. We know that across our device. LUNAR growth was what we anchored people to, and now what we're saying is we knew it would be hard. It's somewhat harder than we expected, but we do continue to look ahead to growth.

不過，我們可以說的是，我們一直都知道，如果我們是一顆小白藥丸，那麼這個過程就會比現在緩慢得多。我們知道這一點，而且是在我們的設備上。LUNAR 成長是我們讓人們關注的焦點，而現在我們想說的是，我們知道這會很困難。這比我們預想的要難一些，但我們仍然期待著未來的發展。

And again, I would point both to ongoing trajectory in the US and Germany and to hopefully a step function increase in that growth from Japan. So that's where we are with LUNAR overall.

我再次指出，美國和德國目前的發展軌跡值得關注，希望日本的成長能出現階躍式成長。這就是 LUNAR 目前的整體進展。

With LUNAR-4, the story there really is about actually the disciplined investments and what we were able to save by looking at the ability to gather that data from real-world evidence, which in the US. I will remind you that approximately 90% of our patients on Optune Lua for non-small cell one cancer have had prior ICI exposure. So we are able to look at the real-world evidence and the experience in the US and publish over time that data to answer a very similar question than LUNAR-4 was asking.

LUNAR-4 的故事實際上講述的是嚴謹的投資，以及我們從現實世界的證據中收集數據而節省的成本，這在美國尤其如此。我提醒各位，我們接受 Optune Lua 治療的非小細胞 1 型癌症患者中，約有 90% 之前接受過 ICI 治療。因此，我們可以查看現實世界的證據和美國的經驗，並隨著時間的推移發布這些數據，以回答與 LUNAR-4 提出的非常相似的問題。

So we do know it is still a very relevant scientific question. We are committed to kind of exploring that question, but it is a far more cost-efficient way for us to do that through real-world evidence.

所以我們知道這仍然是一個非常相關的科學問題。我們致力於探索這個問題，但對我們來說，透過現實世界的證據來進行探索是一種更具成本效益的方法。

This is Christoph. Just to add to what Ashley said, the savings that we expected in the mid to high single-digit million is actually quite worth it.

這是克里斯托夫。補充一下 Ashley 的說法，我們預期節省的數百萬美元實際上是非常值得的。

Jessica Fye, JPMorgan.

潔西卡費伊，摩根大通。

Your line is open. Hey, this is [Tanmai] on for Jess, and thanks for taking the question. My first question is, we now know that active patients for non-small cell lung cancer grew to 100 in 3Q, but given the sequential decline in prescription, could you probably just expand on the underlying dynamics there? And second question would be if you could expand on the gross margin trajectory and over what time horizon can we think about that recovering or maybe not even exceeding historical levels? Thank you.

您的線路已開通。大家好，我是[Tanmai]，替Jess回答問題，謝謝你提出這個問題。我的第一個問題是，我們現在知道非小細胞肺癌的活躍患者在第三季度增加到 100 人，但考慮到處方量的連續下降，您能否詳細闡述其中的潛在動態？第二個問題是，您能否詳細說明毛利率的走勢，以及我們可以考慮在多長時間內恢復到歷史水平，甚至可能無法超過歷史水平？謝謝。

Sorry, could I just ask to clarify the first question around prescription and patient volumes?

不好意思，我能否就處方量和病人數量方面的第一個問題問一下，做個更詳細的說明？

Yeah, okay. So for the non-small cell lung cancer, we now have 100 patients in 3Q. However, we see a sequential decline in prescription volume, so could you maybe just expand on the underlying dynamics there?

好的。所以，對於非小細胞肺癌，我們現在第三季有 100 名患者。然而，我們看到處方量呈現逐年下降趨勢，您能否詳細解釋背後的原因？

So thank you for the question. So yes, what we do see is that we focus internally, our big focus is on active patients. There's always a bit of noise in prescription volumes because it's a question of some practices write prescriptions before they've really educated the patient. Some practices only write the prescription when they're ready for the patient to start. And I think we need a few more quarters in lung cancer before we really settle into what a fill rate would look like. So for right now, I would ignore the noise around prescriptions.

謝謝你的提問。所以，是的，我們看到的情況是，我們把重點放在內部，我們的主要關注點是活躍的患者。處方量總是會有些波動，因為有些診所會在真正向病人進行健康教育之前就開處方。有些診所只有在準備讓病人開始治療時才會開處方。我認為，在真正確定肺癌治療率之前，我們還需要幾個季度的時間來觀察肺癌的進展。所以目前來說，我會忽略圍繞處方藥的各種雜音。

I can take the question on gross margin. So we had maybe just to take a step back, in the quarter we had a gross margin of 73%. And at the beginning of the year, what we said is what we would expect during the year is the gross margin to come closer to lower 70s, driven by a couple of headwinds. One is the rollout of the HFE rate. Two is basically was the lung cancer indication where we launched before getting reimbursement. And then there was another headwind that came to it, it was tariffs.

我可以回答有關毛利率的問題。所以，我們或許應該退後一步，本季我們的毛利率為 73%。年初時，我們曾預測，受一些不利因素的影響，今年毛利率將接近 70% 左右。一是推出HFE利率。第二點基本上是指肺癌適應症，我們在獲得醫保報銷之前就推出了該產品。然後，又出現了另一個不利因素，那就是關稅。

So if you now look at it all together, we're actually pleased with the cost reduction journey that we have been able to accelerate on the HFE rates. So as a result for this year, we see the gross margin get closer to kind of the mid 70s, as opposed to the lower 70s.

所以，綜合來看，我們對在 HFE 費率方面加快降低成本的進程感到滿意。因此，今年的毛利率將接近 70% 左右，而不是 70% 左右。

Now, when we look ahead, our gross margin will be impacted by the launches and the launch trajectories. And that really comes back to the fact that in order to get reimbursement, for us it's a process. It doesn't come with approval. And we will be starting to meet patients in markets where we expect to be reimbursed before we have the actual reimbursement. So there will be a gap between starting off patients and getting reimbursement, and that will impact our gross margin. And quite honestly, the more successful we are, the more it will impact the gross margin during this transition period.

展望未來，我們的毛利率將受到發射次數和發射軌跡的影響。歸根結底，對我們來說，獲得報銷是一個過程。它未經批准。我們將在實際獲得報銷之前，開始在預期能夠獲得報銷的市場與患者見面。因此，從開始接診病人到獲得報銷之間會存在一個時間差，這將影響我們的毛利率。坦白說，我們越成功，在這個過渡時期對毛利率的影響就越大。

Now, I think what's important is we are somewhat in control of this because we can accept the patients or not accept the patients if you don't get reimbursement in the timeline that we want. And so our gross margin, there will be a little bit of noise as we go through the launches. We expect it to come back to higher levels when we're through this period, which is in the higher 70s.

我認為重要的是，我們對此有一定的控制權，因為如果不能在規定的時間內獲得報銷，我們可以選擇接受或不接受病人。因此，隨著產品陸續上市，我們的毛利率可能會出現一些波動。我們預計，當這段時期過去後，氣溫將回升到更高的水平，目前氣溫在70%以上。

And I would just say in all scenarios, when we look at profitability as defined by adjustability, but the one rate remain committed to that path and can see getting there throughout those launches.

我只想說，在所有情況下，當我們從可調整性的角度看待盈利能力時，我們始終堅持這一目標，並且可以看到透過這些產品發布實現這一目標。

Jonathan Chang with Levering Partners.

Jonathan Chang，來自 Levering Partners。

Hey, this is Yiwen for Jonathan. Thanks for taking our questions. So one more on the Optune Lua launch in [Luang]. So you reported 84 unique prescribers. Can you provide some clarification on what you mean by unique prescribers? Can you provide some clarification on whether that's specific to Q3 or that's cumulative since the launch or something else?

嗨，我是代表喬納森的易文。謝謝您回答我們的問題。關於 Optune Lua 發布還有一點需要說明。[鑾]所以你們報告了 84 位不同的處方醫生。您能否解釋一下您所說的「獨特的處方者」是什麼意思？能否澄清一下，這是指第三季特有的情況，還是自產品發布以來累積的情況，或者另有其他情況？

And then one follow-up, if I may, on profitability. Can you provide more color on what goes into your goal of breaking even in 2027? Thank you.

如果可以的話，我想就獲利能力問題再補充一點。您能否詳細說明您為實現 2027 年收支平衡的目標所採取的措施？謝謝。

So, [Ava], that stat is specific to Q3. So that's an easy answer. And I will point out the takeaway there that it's been consistent across quarters, and what we're seeing is that we're able to bring both new prescribers into the optional treatment journey and we're retaining existing prescribers.

所以，[Ava]，這個統計數據是針對第三季的。答案很簡單。我要指出的是，這一點在各個季度都保持一致，我們看到的是，我們既能夠吸引新的處方醫生加入可選治療方案，又能夠留住現有的處方醫生。

So when we think about that mix between new and returning, we see about a 50% split there, which is a nice trend as we look ahead. And I will also remind everybody, when we look at the profile of patient we're getting, we are seeing that patients approaching 90% of them have prior ICI exposure. So we're also seeing it used in a combination that we know is relevant.

所以，當我們考慮新客戶和回頭客的比例時，我們發現兩者大約各佔 50%，這是一個值得期待的趨勢。我還要提醒大家，當我們查看我們接診的患者情況時，我們發現近 90% 的患者之前都接觸過 ICI。所以我們也看到它被用於一些我們知道是相關的組合。

Yeah, and so on the adjusted EBITDA, your line was a bit faint. What exactly was your question?

是的，關於調整後的 EBITDA，你的那條線有點模糊。你具體想問什麼？

Just more color on what goes into your goal of reaching the breakeven in 2027.

更詳細說明一下，為了實現 2027 年收支平衡的目標，需要考慮哪些因素。

Yeah, okay. So first I'd say this is really no change in messaging. I mean, this is very consistent with commentary in the past. What we said is that we would expect to break even on an adjusted EBITDA level at the revenue of around $700 million to $750 million.

好的。首先我想說，這在訊息傳遞方面並沒有什麼改變。我的意思是，這與過去的評論非常一致。我們當時表示，預計調整後的 EBITDA 水準在營收達到 7 億至 7.5 億美元左右時即可達到損益兩平。

And the range is really explained by two main items, and the one is the level of R&D expenses, which is driven by the pace of enrollment in Phase III trials, in essence; and two, the dynamics that I just talked through in terms of during launch years, we have an impact on gross margin. Both levers are now in control.

而價格波動範圍其實由兩個主要因素決定，一是研發費用水平，這主要取決於 III 期試驗的入組速度；二是我剛才提到的上市年份的動態因素，這些因素會對毛利率產生影響。現在兩個操縱桿都處於控制狀態。

And so again, we expect to break even on an adjusted EBITDA level at a revenue level of $700 million to $750 million, and we expect this to be during 2027. We'll be there on a sustainable basis, meaning up to then, we could be close -- this quarter, we were very close, minus [$3 million]. We believe we'll be sort of bouncing around this break-even on adjusted EBITDA level. During 2027, we believe we will be on a sustainable level.

因此，我們預計在 2027 年，調整後的 EBITDA 將在 7 億美元至 7.5 億美元的營收水準上達到收支平衡。我們將以可持續的方式實現這一目標，這意味著在此之前，我們可能已經非常接近目標——本季度，我們非常接近目標，只差一點點。[300萬美元]我們認為，調整後的 EBITDA 水準將會在損益平衡點附近波動。我們相信，到 2027 年，我們將達到永續發展的水平。

Emily Bodnar, H.C. Wainwright.

艾米莉·博德納，H.C. 溫賴特。

Hi. Good morning. Thanks for taking the question. I guess on the lung side, I was curious with how the launch is going currently. Do you have any kind of internal changes to your expectations for what the opportunity could look like at peak and kind of more color on how we should be thinking about this? More color on how we should be thinking about ramp maybe for next year. And also, what learnings you've had from the launch so far that you can kind of use to make sure the pancreatic launch doesn't kind of fall into a similar pattern? Thank you.

你好。早安.感謝您回答這個問題。我想就肺部方面而言，我很好奇目前的發布情況如何。您對這個機會在巔峰時期可能呈現的景像有任何內部預期變化嗎？能否更詳細地說明一下我們該如何看待這個問題？明年或許應該更詳細地探討我們該如何思考坡道問題。另外，從目前的上市情況來看，您有哪些經驗教訓可以用來確保胰臟癌的上市不會重蹈覆轍？謝謝。

Emily, that's a great question. I'll start with a little bit of what our expectations are internally and then ask Frank to provide some of the learnings. But zooming out, lung is hard, but we do know it's worth it, given the opportunity both long-term but also across the entire portfolio. And the integral cost we're spending is actually quite negligible when we look at the investments we would be making today versus the investments we need to be making for pancreatic and brain meth as we look ahead.

艾米麗，你問得好。我先簡單介紹我們內部的期望，然後請弗蘭克分享一些經驗教訓。但從長遠來看，肺部疾病雖然難以治療，但我們知道這是值得的，因為無論從長期還是從整個投資組合來看，這都是有利的。而我們目前所花費的總成本，與未來我們需要為胰臟和腦部甲基安非他命進行的投資相比，實際上是微不足道的。

So we have adjusted our internal expectations. We are making sure that we have motivated field teams that are focused on the right targets, driving growth. But I will say when we look at investments, the investments we have made are investments in the platform, and they will establish that infrastructure that will treat the full portfolio over the next year.

因此，我們調整了內部預期。我們正在確保我們擁有積極進取、專注於正確目標的現場團隊，從而推動成長。但我想說的是，當我們審視投資時，我們所做的投資都是對平台的投資，這些投資將建立起基礎設施，以便在未來一年內處理整個投資組合。

So while we're always looking at those discerning investments, I will say we really are now looking at the platform. And again, we're confident that those are the right ones as we look to this path to profitability with top line growth coming from four products on the market in the end of the year.

所以，雖然我們一直在關注那些有遠見的投資，但我現在確實在關注這個平台。我們再次確信，這些是正確的選擇，因為我們希望透過這條獲利之路，在年底前實現營收成長，這主要得益於四款產品的上市。

I'm going to ask Frank to provide specifics on pivot in the market.

我將請弗蘭克詳細說明市場轉向的情況。

Thank you. First, to go to the question around how do we view the long-term value, we still see the long-term value in helping non-small cell lung cancer patients. There's a tremendous unmet need in the second line. And as we look even further ahead to the LUNAR-2 trial, there's a huge opportunity within first-line treatment.

謝謝。首先，關於我們如何看待長期價值這個問題，我們仍然認為幫助非小細胞肺癌患者俱有長期價值。第二線存在巨大的未滿足需求。展望 LUNAR-2 試驗，第一線治療領域蘊藏著巨大的機會。

For us, given the data set that we have, we believe we have a compelling reason to be in this market helping the patient.

就我們而言，根據我們掌握的數據，我們相信我們有充分的理由進入這個市場，幫助病人。

In terms of learnings and pivots, I think Bill in his opening noted on the need for education and additional evidence as you work into a new community of doctors. And so on the education front, I think, one, we have the advantage that we are in market already. So physicians are hearing about our lung indication, but by extension, when we go into and have approval to actually market to panc, they won't be naive to the messages.

就學習和轉型而言，我認為比爾在開場白中指出，當你融入一個新的醫生群體時，需要接受教育並獲得更多證據。因此，在教育方面，我認為，第一，我們的優勢在於我們已經進入市場。所以醫生們聽說了我們的肺部適應症，但進一步來說，當我們獲得批准真正將產品推向胰臟癌市場時，他們就不會對這些資訊一無所知了。

Number two is to take a direct learning from lung in terms of the education that we need to do. I'd say we've learned that we need to educate not just the physician, but the practice, the nurses, the physician's assistants, and really everyone in the practice on therapy, because you don't know where the patient will direct their question, their first question about the device.

第二點是直接向肺部學習，了解我們需要進行的教育。我認為我們已經認識到，我們需要對醫生、診所工作人員、護士、醫生助理以及診所裡的每個人進行治療方面的教育，因為你不知道病人會向誰提出問題，他們關於設備的第一個問題會是什麼。

And so I think that's in the real tactical side of things, but it's things that we now know we need to do to be successful in our next medical oncology launch. And then Bill also mentioned the need for continued evidence generation. So I think one thing we've done for panc is ensure that at FDA launch, we're also in the process of closing out the PANOVA-4 data set. So trying to take those learnings and really lead towards an excellent launch in panc.

所以我認為這才是真正的戰術層面問題，但我們現在知道，為了在下一次腫瘤內科藥物上市中取得成功，我們需要做這些事情。然後比爾也提到了需要繼續收集證據。所以我認為我們為 panc 所做的一件事是確保在 FDA 發布的同時，我們也正在完成 PANOVA-4 資料集的收尾工作。所以，我正努力吸取這些經驗教訓，力求在 Panc 上取得圓滿成功。

And I'm not showing any further questions at this time. I'd like to turn the call back to Bill Doyle for any further remarks.

我目前不會再提出其他問題。我想把電話轉回給比爾·道爾，讓他再發表一些看法。

Thank you, Kevin. I'd like to conclude the call where I began. Everyone in Novocure comes to work every day to help patients extend their survivals in these really aggressive cancers. We've been working very hard for years to help patients with GBM, and we are now excited and in the middle of our preparation to become a true platform company, serving, again, patients in four indications by the end of next year.

謝謝你，凱文。我想以我開始談論的內容來結束這通通話。Novocure 的每一位員工每天都來上班，幫助患者延長在這些極具侵襲性的癌症中的生存期。多年來，我們一直努力幫助膠質母細胞瘤患者，現在我們感到非常興奮，並且正在積極準備成為一家真正的平台公司，到明年年底，我們將再次為四項適應症的患者提供服務。

Our pipeline's on track. We were very pleased with the clinical recognition we've received for PANOVA-3 and METIS. And on the financial front, again, we expect now four diversified revenue streams, and we're committed to marching forward toward profitability.

我們的專案進展順利。我們對 PANOVA-3 和 METIS 獲得的臨床認可感到非常高興。在財務方面，我們預計目前將有四個多元化的收入來源，並且我們致力於朝著獲利目標穩步前進。

So we have an exciting 15 months ahead, 6 major country-level launches, 2 important data readouts, and meaningful product improvements that we continue to focus on and will be rolling out.

因此，未來 15 個月我們將迎來激動人心的時刻，6 個主要國家級產品發布，2 個重要數據發布，以及我們將繼續關注並推出的有意義的產品改進。

So with that, I want to thank the Novocure team for all their hard work and for your attention and support today.

在此，我要感謝Novocure團隊的辛勤付出，也感謝大家今天的關注與支持。

Thank you. Ladies and gentlemen, this does conclude today's presentation. We thank you for your participation. You may now disconnect and have a wonderful day. Thank you.

謝謝。女士們、先生們，今天的演講到此結束。感謝您的參與。現在您可以斷開連接，祝您度過美好的一天。謝謝。