Novocure Ltd (NVCR) 2025 Q1 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Novocure First Quarter 2025 Earnings Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. (Operator Instructions) Please be advised that today's conference is being recorded.

您好，感謝您的支持。歡迎參加 Novocure 2025 年第一季財報電話會議。此時，所有參與者都處於只聽模式。演講者演講結束後，將有問答環節。（操作員指示）請注意，今天的會議正在錄音。

I would now like to hand the conference over to your host for today's conference, Ingrid Goldberg. Please go ahead.

現在，我想將會議交給今天會議的主持人英格麗德·戈德堡 (Ingrid Goldberg)。請繼續。

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

早安，感謝您與我們一起回顧 Novocure 2025 年第一季的業績。今天早上我與我們的執行主席 Bill Doyle、執行長 Ashley Cordova 和財務長 Christoph Brackmann 通了電話。我們的領導團隊的其他成員將參與問答。供您參考，此收益報告隨附的幻燈片可在我們的網站 www.novocure.com 的「投資者關係」頁面的「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 and 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 statements, 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，並且會不時在我們提交給美國證券交易委員會的文件中描述。除非法律要求，否則我們不打算公開更新任何前瞻性聲明。

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

在適當的情況下，我們可能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，最能反映我們的業務產生的財務價值。

Reconciliations of non-GAAP to GAAP financial measures are included in our press release, earnings slides and in our Form 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 與 GAAP 財務指標的對帳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 10-Q 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。在我們今天的準備好的發言之後，我們將開放熱線回答大家的提問。

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

現在我將把電話轉給我們的執行主席比爾·道爾 (Bill Doyle)。

Thank you, Ingrid, and good morning.

謝謝你，英格麗德，早安。

For 25 years our mission at Novocure, has been to extend survival for patients with some of the most aggressive forms of cancer, through the development and commercialization of tumor treating fields. 2025 is set to be a defining year for Novocure, as we move from a single indication treating patients with GBM, to becoming a multi indication oncology company.

25 年來，Novocure 的使命一直是透過腫瘤治療領域的開發和商業化，延長某些最具侵襲性的癌症患者的生存期。 2025 年將成為 Novocure 的決定性一年，因為我們將從治療膠質母細胞瘤 (GBM) 患者的單一適應症轉變為治療多種適應症的腫瘤學公司。

With five successful Phase 3 clinical trials in hand, our focus is squarely on execution, particularly on the regulatory and commercial fronts. This morning, we will discuss early feedback from our non-small cell lung cancer launch, provide commercial and clinical pipeline updates, and then turn to our quarterly financial performance.

我們已經成功完成了五項 3 期臨床試驗，現在我們的重點是執行，尤其是監管和商業方面。今天上午，我們將討論非小細胞肺癌發布的早期回饋，提供商業和臨床管道更新，然後討論我們的季度財務表現。

But before we dive into the quarterly updates, I would like to highlight two items of breaking news. On Tuesday morning, we announced that Optune Lua received European CE Mark approval, for the treatment of metastatic non-small cell lung cancer. We were pleased to receive a broad label, which includes concomitant treatment with both immune checkpoint inhibitors, or docetaxel. Our team in Germany is ready to launch, pending local registration.

但在我們深入討論季度更新之前，我想強調兩則突發新聞。週二上午，我們宣布 Optune Lua 獲得歐洲 CE 標誌批准，用於治療轉移性非小細胞肺癌。我們很高興收到一份廣泛的標籤，其中包括免疫檢查點抑制劑或多西他賽的聯合治療。我們在德國的團隊已準備好啟動，等待當地註冊。

Also, we were pleased to announce yesterday that the results of our PANOVA-3, our successful Phase 3 clinical trial in unresectable locally advanced pancreatic cancer, were accepted for presentation at the upcoming American Society of Clinical Oncology Annual Meeting. Data from the PANOVA-3 trial will be presented on Saturday, May 31, by lead investigator Dr. Vincent Picozzi of the Virginia Mason Medical Center, as part of the Gastrointestinal Cancer Oral Abstracts Clinical session.

此外，我們昨天很高興地宣布，我們在不可切除的局部晚期胰腺癌中成功的 3 期臨床試驗 PANOVA-3 的結果已被接受在即將舉行的美國臨床腫瘤學會年會上展示。PANOVA-3 試驗的數據將於 5 月 31 日星期六由弗吉尼亞梅森醫療中心的首席研究員 Vincent Picozzi 博士在胃腸道癌症口頭摘要臨床會議中公佈。

That evening at 7 p.m. Central Time, we plan to host an investor event, with a live webcast to dive into the results with Dr. Picozzi, and members of our management team. Pancreatic cancer is one of the deadliest forms of cancer, with an estimated five-year survival rate of only 13% and a growing global incidence.

當晚美國中部時間晚上 7 點，我們計劃舉辦一場投資者活動，並透過網路直播與 Picozzi 博士和我們的管理團隊成員一起深入探討研究結果。胰臟癌是最致命的癌症之一，估計五年存活率僅 13%，全球發生率呈上升趨勢。

PANOVA-3 is the first and only Phase 3 trial, to demonstrate a meaningful survival benefit, in locally advanced pancreatic cancer. Presentation of the PANOVA-3 data on the main stage at ASCO, will bring important visibility to the potential, for tumor treating fields, to meaningfully bend the survival curve in pancreatic cancer. We look forward to discussing the PANOVA-3 results, with clinicians and investors next month.

PANOVA-3 是第一個也是唯一一個證明局部晚期胰腺癌具有顯著生存益處的 3 期試驗。在 ASCO 主會場上展示 PANOVA-3 數據，將為腫瘤治療領域顯著改善胰臟癌生存曲線的潛力帶來重要的啟示。我們期待下個月與臨床醫生和投資者討論 PANOVA-3 的結果。

I'll now turn the call over to Ashley, to provide further updates on Q1.

現在我將把電話轉給 Ashley，以提供有關 Q1 的進一步更新。

Thank you, Bill.

謝謝你，比爾。

It has been an exciting quarter for our team, and I am proud of the milestones we've hit, already this year. Our mission has never felt more urgent, as we expand our reach to more patients, facing some of the most challenging solid tumors, with significant unmet needs.

對於我們的團隊來說，這是一個令人興奮的季度，我為我們今年已經達到的里程碑感到自豪。我們的使命從未如此緊迫，因為我們將服務範圍擴大到更多的患者，他們面臨著一些最具挑戰性的實體腫瘤，並且存在大量未滿足的需求。

Last October, we received PMA approval for Optune Lua in our newest indication, metastatic non-small cell lung cancer, and immediately initiated our U.S. launch. After a strong start, we remain highly encouraged by the early commercial indicators. In the first quarter, we received 92 non-small cell lung cancer prescriptions, and ended the period with 62 patients on therapy.

去年 10 月，我們獲得了 Optune Lua 用於治療最新適應症轉移性非小細胞肺癌的 PMA 批准，並立即在美國啟動了上市銷售。在強勁開局之後，我們仍然對早期的商業指標感到非常鼓舞。第一季度，我們收到了 92 張非小細胞肺癌處方，結束時有 62 名患者接受了治療。

We also had 44 mesothelioma patients on therapy, for a total of 106 Optune Lua active patients. These early results in non-small cell lung cancer, reflect our focus and disciplined launch strategy, centered on reaching the right physicians for the right patients at the right time. Our initial efforts have concentrated, on engaging physicians most likely to adopt Optune Lua, those open to novel treatment modalities, and eager to engage with us in advancing patient care.

我們也對 44 名間皮瘤患者進行了治療，總共有 106 名 Optune Lua 活躍患者。這些非小細胞肺癌的早期結果反映了我們的重點和嚴謹的發布策略，即在正確的時間為正確的患者找到正確的醫生。我們最初的努力集中在吸引最有可能採用 Optune Lua 的醫生、那些對新治療方式持開放態度並渴望與我們合作推進患者護理的醫生。

Many of these physicians operate in community settings, where the majority of non-small cell lung cancer patients are treated. We're seeing encouraging breadth in prescriber interest. As of March 31, we have received prescriptions from 93 unique prescribers, with 60% of these prescribers new to tumor treating fields therapy. Many come from institutions that have never prescribed Optune Gio for GBM.

許多醫生在社區環境中工作，大多數非小細胞肺癌患者在那裡接受治療。我們看到處方醫生的興趣日益濃厚。截至 3 月 31 日，我們已收到 93 位獨立處方者的處方，其中 60% 是首次接受腫瘤治療領域治療的處方者。許多人來自從未使用 Optune Gio 治療膠質母細胞瘤的機構。

General medical oncologists, represent the largest share of prescribers and radiation oncologists, are emerging as important users and advocates. Our FDA label enables patients to use Optune Lua, together with either a checkpoint inhibitor or docetaxel following progression, after prior exposure to platinum chemotherapy. This aligns well with real world treatment patterns.

全科腫瘤科醫生佔處方醫生和放射腫瘤科醫生的最大份額，正在成為重要的使用者和倡導者。我們的 FDA 標籤允許患者在接受鉑類化療後，在病情進展後使用 Optune Lua 以及檢查點抑制劑或多西他賽。這與現實世界的治療模式非常吻合。

While newer biomarker specific therapies dominate headlines, only about 30% of lung cancer patients qualify for these options. Most patients receive a platinum chemo plus an immune checkpoint inhibitor in the first line, positioning them squarely within our on-label population. We see three primary patient populations driving early adoption. First, there are those patients who responded to first line ICI and platinum chemo, but show early signs of relapse. This is the smoldering progressor population we have referenced in the past.

儘管較新的生物標記特異性療法佔據了頭條新聞，但只有約 30% 的肺癌患者有資格選擇這些療法。大多數患者在第一線接受鉑類化療加上免疫檢查點抑制劑治療，這使他們完全符合我們的標籤族群標準。我們發現有三個主要患者群體推動早期採用。首先，有些患者對第一線 ICI 和鉑類化療有反應，但出現復發的早期跡象。這就是我們過去提到的熱火朝天的進步群體。

Second, are patients who received ICI and platinum chemo on the first line, but who did not respond, have progressed and are motivated to seek second line treatment for rapidly progressing disease. Finally, there are low or non-PD-L1 expressors that received platinum-based chemo as monotherapy in the first line, have progressed, and are looking for a better alternative to long-term chemo monotherapy.

第二類是接受 ICI 和鉑類化療第一線治療但未產生反應的患者，病情已出現進展，並有動力尋求二線治療以治療快速進展的疾病。最後，PD-L1 表達較低或不表達的患者，第一線接受鉑類化療作為單一療法，病情出現進展，正在尋找比長期化療單一療法更好的替代方案。

Each of these groups, represent sizable patient populations, with limited treatment options prior to the launch of Optune Lua. Combined, we believe these groups, represent approximately 30,000 eligible patients in the U.S. annually. Encouragingly, our early adoption includes patients from all three populations. Of the 62 non-small cell lung cancer active patients on therapy at quarter end, there was roughly a 50-50 split between concomitant ICI and docetaxel use.

這些群體都代表著相當可觀的患者群體，在 Optune Lua 推出之前，他們的治療選擇有限。我們認為，這些群體合計每年代表著美國約 3 萬名符合條件的患者。令人鼓舞的是，我們早期的採用涵蓋了所有三個群體的患者。在季度末接受治療的 62 名非小細胞肺癌活躍患者中，同時使用 ICI 和多西他賽的比例約為 50-50。

As of March 31, over 90% of the patients who were prescribed Optune Lua, were previously treated with an immune checkpoint inhibitor, a clear indicator that physicians are comfortable, with continued ICI treatment in the second line. Beyond reaching the right physicians and the right patients, our third focus for launch success is treating patients at the right time.

截至 3 月 31 日，超過 90% 接受 Optune Lua 治療的患者之前都接受過免疫檢查點抑制劑治療，這清楚地表明醫生對繼續進行二線 ICI 治療感到放心。除了找到合適的醫生和合適的患者之外，我們成功推出產品的第三個重點是在正確的時間為患者提供治療。

The right time means three things, reaching physicians and patients that are motivated to move quickly, starting Optune Lua at first sign of progression, and minimizing use as a salvage therapy. Our positioning has been successful thus far. Through the end of Q1, approximately 50% of the prescriptions received were for Optune Lua and second line use, with another 25% prescribed for third line use.

正確的時間意味著三件事，接觸有動力迅速採取行動的醫生和患者，在出現進展的第一個跡象時就開始使用 Optune Lua，並儘量減少將其用作挽救療法。到目前為止，我們的定位是成功的。截至第一季末，收到的處方中約有 50% 用於 Optune Lua 和第二線治療，另有 25% 用於三線治療。

As Bill mentioned, earlier this week we were thrilled to announce CE Mark approval, for the treatment and metastatic non-small cell lung cancer in European markets. Our team is launch ready. As a reminder, we have an Optune Lua sales force in place in Germany that, has been detailing Optune Lua for mesothelioma, over the prior year in preparation for the non-small cell lung cancer launch.

正如比爾所提到的，本週早些時候，我們很高興地宣布獲得 CE 標誌批准，用於治療歐洲市場的轉移性非小細胞肺癌。我們的團隊已做好啟動準備。提醒一下，我們在德國有一個 Optune Lua 銷售團隊，在過去的一年裡一直在詳細介紹用於治療間皮瘤的 Optune Lua，為非小細胞肺癌的推出做準備。

We have initiated the local registration process in Germany, and are preparing to launch non-small cell lung cancer in the coming weeks. This is an important milestone, and we are excited to add a second market to drive Optune Lua growth.

我們已經啟動了德國當地的註冊程序，並準備在未來幾週推出非小細胞肺癌治療。這是一個重要的里程碑，我們很高興增加第二個市場來推動 Optune Lua 的成長。

Looking ahead, regulatory review is ongoing and constructive in Japan. We've begun building out our Japanese commercial team, in anticipation of a launch in Japan later this year. Around the globe, we anticipate adoption to follow a durable medical device like curve that, is linear and sustainable rather than exponential. We remain confident in our ability to expand access, and drive top line growth in the coming years as momentum builds across clinical, commercial and payer communities.

展望未來，日本的監管審查正在進行中並且具有建設性。我們已經開始組建日本商業團隊，準備在今年稍後在日本推出產品。我們預計，在全球範圍內，耐用醫療設備的採用將遵循類似曲線的趨勢，即線性和可持續的，而不是指數級的。隨著臨床、商業和付款人群體的勢頭增強，我們仍然對自己擴大管道和在未來幾年推動營收成長的能力充滿信心。

Turning to our [Bedrock] GBM business, Q1 performance was strong with a record 4,162 active patients globally. We saw continued year-over-year patient growth, particularly in France and Japan. Our GBM business serves as an important springboard, for product and service enhancements that, will be leveraged across future indications.

談到我們的 [Bedrock] GBM 業務，第一季表現強勁，全球活躍患者數量達到創紀錄的 4,162 名。我們看到患者數量持續逐年增加，尤其是在法國和日本。我們的 GBM 業務是產品和服務增強的重要跳板，將在未來的適應症中得到利用。

The most recent example is the rollout of the HFE array, which is now standard for all new GBM patients in all active markets. While the HFE array is designed for head applications, feedback from patients and caregivers on the new materials and design elements, will be invaluable in the design of our next generation torso and abdominal arrays.

最近的例子是 HFE 陣列的推出，它現在是所有活躍市場中所有新 GBM 患者的標準。雖然 HFE 陣列專為頭部應用而設計，但患者和照護者對新材料和設計元素的回饋對於我們下一代軀幹和腹部陣列的設計將非常有價值。

We also recently launched a patient app, available on both the iTunes App Store and Google Play. Our app is an exciting advance for patients, as it allows them to follow their individual daily usage rates, order new supplies at the touch of a button and troubleshoot any issues with the device. We recently cleared 1,400 app users in the U.S., representing a significant portion of the 2,100 plus U.S. active patients.

我們最近也推出了一款患者應用程序，可在 iTunes App Store 和 Google Play 上下載。我們的應用程式對患者來說是一個令人興奮的進步，因為它允許患者追蹤個人的每日使用率，只需按一下按鈕即可訂購新耗材並排除設備的任何問題。我們最近在美國清理了 1,400 名應用程式用戶，占美國 2,100 多名活躍患者的很大一部分。

Next generations of the app with greater functionality and international access, are in the design phase now. Personal app-based tools not only improve the patient experience, they also set the stage for scalable high touch services, as we enter a multi indication feature.

該應用程式的下一代版本具有更強大的功能和國際訪問權限，目前正處於設計階段。基於個人應用程式的工具不僅可以改善患者體驗，還可以為可擴展的高接觸服務奠定基礎，因為我們進入了多指示功能。

Turning to regulatory catalysts, PMA submissions for both METIS and PANOVA-3 remain on track for 2025. Our modular PMA shell for the METIS application, has been approved by the FDA. Modules 1 and 2 were submitted earlier this month, and are now under FDA review.

談到監管催化劑，METIS 和 PANOVA-3 的 PMA 提交在 2025 年仍將按計劃進行。我們用於 METIS 應用的模組化 PMA 外殼已獲得 FDA 批准。模組 1 和 2 已於本月初提交，目前正在接受 FDA 審查。

We are also making steady progress towards submission of a PMA for locally advanced pancreatic cancer based on the PANOVA-3 data, including active presubmission engagement with the FDA. These early discussions, are helping shape the structure and content of our formal filing, and will support a smooth review process.

我們也在根據 PANOVA-3 數據提交局部晚期胰腺癌 PMA 方面取得穩步進展，包括與 FDA 進行積極的提交前接觸。這些早期的討論有助於確定我們正式文件的結構和內容，並將支持順利的審查過程。

On the clinical front, we are focused on studying applications of tumor treating fields that, could further expand our addressable markets in pancreatic and lung cancers, maximize duration of therapy and broaden the data supporting use in GBM. Our pipeline is largely focused on studying the concomitant use, of tumor treating fields and immune checkpoint inhibitors, a regimen that continues to show immense promise across indications. We are opening sites and enrolling patients in our Phase 3 KEYNOTE D58 and LUNAR-2 trials, and our Phase 2 LUNAR-4 trial.

在臨床方面，我們專注於研究腫瘤治療領域的應用，這可以進一步擴大我們在胰腺癌和肺癌方面的潛在市場，最大限度地延長治療時間，並拓寬支持在膠質母細胞瘤（GBM）中使用的數據。我們的研發管線主要集中在研究腫瘤治療場和免疫檢查點抑制劑的聯合使用，該方案在各個適應症中繼續顯示出巨大的前景。我們正在開放試驗點並招募患者參與我們的第 3 階段 KEYNOTE D58 和 LUNAR-2 試驗以及第 2 階段 LUNAR-4 試驗。

Our Phase 3 TRIDENT trial, and our Phase 2 PANOVA-4 trial, are both fully enrolled and in follow-up, with top line data readouts expected in the first half of 2026. We believe our clinical pipeline provides us with the potential, to deliver tumor treating fields therapy, to tens of thousands of additional patients annually.

我們的 3 期 TRIDENT 試驗和 2 期 PANOVA-4 試驗均已完全入組並正在進行後續跟進，預計將於 2026 年上半年獲得頂線數據讀數。我們相信，我們的臨床管線為我們提供了潛力，每年為數以萬計的額外患者提供腫瘤治療場療法。

In summary, this is a moment of meaningful momentum for Novocure. After years serving patients in a single commercial indication, our footprint is expanding to new indications, new centers and new physician specialties. Our lung launch is progressing, our pipeline is advancing, and our commitment to patient forward innovation, is stronger than ever. We look forward to updating you on our progress, as the year unfolds.

總而言之，對 Novocure 來說，這是一個意義重大的時刻。經過多年為單一商業適應症的患者提供服務後，我們的業務範圍正在擴展到新的適應症、新的中心和新的醫師專業。我們的肺部產品上市正在取得進展，我們的產品線正在推進，我們對患者創新的承諾比以往任何時候都更加堅定。隨著時間的推移，我們期待向您通報我們的進展。

With that, I'll turn the call to Christoph, to discuss our financial performance in the quarter.

說完這些，我將把電話轉給克里斯托夫，討論我們本季的財務表現。

Thank you, Ashley.

謝謝你，阿什利。

2025, is off to a strong start. In the first quarter, we generated $155 million of net revenue, an increase of 12% from the first quarter of last year. This was primarily driven by 11% growth in active patients, and to a lesser extent from reimbursement improvements. We grew active patients, compared to prior year by 46% in France, 17% in Japan, 10% in Germany, and 4% in the U.S.

2025 年，開局強勁。第一季度，我們實現淨營收1.55億美元，較去年第一季成長12%。這主要是由於活躍患者數量增加了 11%，其次是報銷改善。與前一年相比，我們的活躍患者數量增長了，法國增長了 46%，日本增長了 17%，德國增長了 10%，美國增長了 4%。

We collected $1.5 million from Optune Lua claims in the quarter, which was split roughly 50-50, between MPM and NSCLC. It's encouraging to see the initial results of our NSCLC reimbursement efforts, in the form of approvals and positive outcomes from appeals. As a reminder, according to U.S. GAAP, we recognize revenue by applying our estimated future collection rate at time of billing.

本季度，我們從 Optune Lua 索賠中收取了 150 萬美元，其中 MPM 和 NSCLC 的索賠金額大致各佔 50%。看到我們的 NSCLC 報銷工作取得了初步成果，包括批准和上訴的積極結果，令人鼓舞。提醒一下，根據美國公認會計準則，我們透過在開票時應用預計的未來收款率來確認收入。

Since NSCLC is a new indication, we will need to build a collection track record, to support a collection rate estimate, to enable revenue recognition upon billing. Until we build a track record, our revenue from non-small cell lung cancer claims, will reflect cash collections in the period.

由於 NSCLC 是一種新適應症，我們需要建立收款記錄，以支援收款率估算，以便在開立發票時確認收入。在我們建立業績記錄之前，我們從非小細胞肺癌索賠中獲得的收入將反映該期間的現金收款。

Our gross margin for the quarter was 75%, compared to 76% in the prior year period. The reduction of gross margin was primarily driven, by the rollout of our HFE arrays and the NSCLC launch, where we are treating unlabeled patients at risk, prior to establishing broad reimbursement. This is consistent with discussions in prior periods, and we expect these headwinds to lessen, as we establish reimbursement in non-small cell lung cancer, and lower the cost of the new HFE arrays.

本季我們的毛利率為 75%，去年同期為 76%。毛利率的下降主要是由於我們推出 HFE 陣列和 NSCLC，在建立廣泛的報銷之前，我們正在治療未標記的高風險患者。這與前期的討論一致，我們預計這些不利因素將會減少，因為我們建立了非小細胞肺癌的報銷制度，並降低了新的 HFE 陣列的成本。

Additionally, we anticipate some gross margin headwinds, due to the evolving tariff landscape. Our most significant exposure, is from the import of arrays into the U.S. from Israel, with lesser potential impacts from imports from Mexico and Europe. If tariffs return to the increased rates announced, before the current 90-day pause, we estimate import duties could impact our 2025 cost of goods, by up to $11 million.

此外，由於關稅情勢的變化，我們預期毛利率將面臨一些阻力。我們最大的風險來自於從以色列進口陣列到美國，而從墨西哥和歐洲進口的潛在影響較小。如果關稅在目前的 90 天暫停期之前恢復到宣布的上調稅率，我們估計進口關稅可能會對我們 2025 年的商品成本產生高達 1,100 萬美元的影響。

In a scenario, where this pause is extended through year end, we estimate that annual cost of goods, could be impacted by up to $8 million. We are driving several supply chain optimization initiatives, to mitigate the incremental headwind from tariffs.

如果這項暫停措施持續到年底，我們估計每年的商品成本可能會受到高達 800 萬美元的影響。我們正在推動多項供應鏈優化舉措，以減輕關稅帶來的增量阻力。

Moving down the P&L. Research and development costs for the quarter, were $54 million, an increase of 4% from the same period in 2024. We do not expect R&D expenses, to take a material step up this year, as we ramp down spend on some large Phase 3 trials, and ramp up spend on others.

降低損益。本季研發成本為 5,400 萬美元，較 2024 年同期成長 4%。我們預計今年的研發費用不會大幅增加，因為我們減少了一些大型 3 期試驗的支出，同時增加了其他試驗的支出。

Sales and marketing expenses in the quarter, were $56 million, an increase of 1% from Q1 of last year. Our thoracic sales forces in the U.S. and Germany, are fully staffed and reflected in our Q1 operating expense. Looking ahead, we expect some incremental expense primarily from marketing, and in preparation for launch in additional countries.

本季銷售和行銷費用為 5,600 萬美元，較去年第一季成長 1%。我們在美國和德國的胸腔銷售隊伍已配備齊全，並反映在我們的第一季營運費用中。展望未來，我們預期一些增量支出主要來自行銷以及在其他國家推出產品的準備。

G&A expenses for the quarter were $45 million, an increase of 13% from the first quarter of 2024. This increase was primarily, due to a one-time $2.3 million expense, to retire production line related to supply chain optimization efforts, and personnel and professional expenses, to support the NSCLC launch and potential additional launches. We believe our current G&A footprint, can be leveraged to treat patients across multiple indications, so that we would expect only modest increases in spending in the foreseeable future.

本季的一般及行政費用為 4,500 萬美元，較 2024 年第一季成長 13%。這一增長主要是由於一次性支出 230 萬美元，用於淘汰與供應鏈優化工作相關的生產線，以及人員和專業費用，以支持 NSCLC 的推出和潛在的額外推出。我們相信，我們目前的 G&A 足跡可用於治療多種適應症的患者，因此我們預計在可預見的未來支出只會適度增加。

Net loss for the quarter was $34 million, with a loss per share of $0.31. Adjusted EBITDA in the quarter was negative $5 million, and our current cash and investment balance at the end of Q1, was $929 million. Reaching profitability is a key focus for us, as we prepare for multiple potential new product launches in the coming years.

本季淨虧損為3,400萬美元，每股虧損0.31美元。本季調整後EBITDA為負500萬美元，截至第一季末，我們的現金及投資餘額為9.29億美元。實現獲利是我們關注的重點，因為我們準備在未來幾年推出多款新產品。

While investing for growth, we are determined to keep our operating expenses measured, and we believe we can leverage many areas of our current infrastructure, to meet the needs of multiple launches.

在投資成長的同時，我們決心控制營運費用，並且我們相信我們可以利用現有基礎設施的許多領域來滿足多次發布的需求。

With the cash and short-term investments currently on our balance sheet, as well as the capital available through our credit facility, we believe that we have the funds necessary, to retire our convertible note, due in November and bridge to new revenue streams, from future indications.

憑藉我們資產負債表上目前的現金和短期投資，以及透過信貸安排可用的資本，我們相信，我們擁有必要的資金，可以贖回 11 月到期的可轉換票據，並從未來跡象來看，過渡到新的收入來源。

To close, I'd like to take a step back, and reflect on my first quarter enroll. This is an incredibly exciting time for Novocure, as we pivot from a single indication, to a multi-indication company. Tumor treating field therapy, has been clinically derisked in several important cancer indications, through large randomized Phase 3 trials. We have built a sustainable business that, provides the financial strength to launch in these new indications, and pursue an ambitious clinical pipeline to further expand our reach.

最後，我想回顧一下，回顧一下我第一季的招生情況。對於 Novocure 來說，這是一個無比令人興奮的時刻，因為我們從單一適應症公司轉型為多適應症公司。腫瘤治療場療法已透過大規模隨機 3 期試驗在幾種重要的癌症適應症中得到臨床降低風險。我們已經建立了可持續發展的業務，為推出這些新適應症提供了財務實力，並追求雄心勃勃的臨床管道，以進一步擴大我們的影響力。

Our infrastructure and institutional knowledge, can be leveraged for growth in the coming years. We are confident in our technology, in our team and in our ability, to reach many more patients in need, and drive substantial revenue growth. We look forward, to updating you on our progress as we do so, and to seeing many of you at ASCO.

我們的基礎設施和機構知識可以在未來幾年內促進成長。我們對我們的技術、我們的團隊和能力充滿信心，能夠幫助更多有需要的患者，並推動大幅的收入成長。我們期待向你們通報我們的進展情況，並期待在 ASCO 見到你們。

We will now turn to our operator, for your questions.

現在我們將聯絡接線員來回答您的問題。

(Operator Instructions)

（操作員指示）

Larry Biegelsen with Wells Fargo.

富國銀行的 Larry Biegelsen。

Good morning. Thanks for taking the question. Congrats on a nice quarter here. Bill or Ashley, I wanted to ask one on non-small cell lung cancer, one on PANOVA-3. So just starting with non-small cell lung cancer, we're trying to benchmark the launch to newly diagnosed GBM. Just as obviously a benchmark, the scripts look like they're about 25% of newly diagnosed GBM scripts at the same time, post launch, active patients about two-thirds. How are you viewing the ramp of non-small cell lung cancer after I know only two quarters, but versus newly diagnosed GBM. We're just trying to understand how big non-small cell lung cancer can be relative to GBM. Any color on how you're seeing the curve so far and I had one follow-up?

早安.感謝您回答這個問題。恭喜本季取得良好成績。Bill 或 Ashley，我想問一個關於非小細胞肺癌的問題，一個關於 PANOVA-3 的問題。因此，從非小細胞肺癌開始，我們試圖將啟動基準設定為新診斷的膠質母細胞瘤 (GBM)。顯然，這是一個基準，這些處方看起來同時佔新診斷的 GBM 處方的 25% 左右，在上市後，活躍患者約佔三分之二。據我所知，僅兩個季度後，您如何看待非小細胞肺癌發病率的增長，但與新診斷的 GBM 相比。我們只是想了解非小細胞肺癌相對於膠質母細胞瘤 (GBM) 有多大。到目前為止，您對曲線有何看法？我有一個後續問題嗎？

Yes, sure Larry, this is Ashley. Good to hear from you. And I'll actually add Frank to provide some color on those launch after the answer, the short answer is it's hard to tie it to newly diagnosed GBM, Larry. And I know that's hard, because you want the analog, but it is a different setting. This is a general medical oncologist. This is an oncology community that now knows tumor treating fields.

是的，當然可以，拉里，這是阿什莉。很高興收到你的來信。實際上，我會在回答之後添加弗蘭克來為這些發布提供一些顏色，簡短的回答是，很難將其與新診斷的 GBM 聯繫起來，拉里。我知道這很難，因為你想要模擬，但這是一個不同的設定。這是一位普通腫瘤科醫師。這是一個現在了解腫瘤治療領域的腫瘤學界。

Because we're not launching in our first indication, and it's just a different patient segment. So the better anchor I would say, is to look at this population of the 30,000 annual eligible patients, to look at the 93 unique prescribers that we built, and to say that we have the sales force in place that we need, to be able to detail the high decile physicians that, are prescribed a non-small cell lung cancer.

因為我們並不是首次推出該藥物，而只是針對不同的患者族群。因此，我認為更好的錨點是，看看每年 30,000 名符合條件的患者群體，看看我們建立的 93 個獨特處方者，並說我們已經擁有所需的銷售隊伍，能夠詳細說明被開具非小細胞肺癌處方的高十分位數醫生。

And I would, I know that's not a direct analog to newly diagnosed GBM, but I think actually our trajectory in prior quarters is a better analog. And we're very pleased where this has gone post-launch and through Q1. And then maybe I'll pass it to Frank, to add some color.

我知道這與新診斷的膠質母細胞瘤 (GBM) 不是直接類似，但我認為實際上我們前幾季的軌跡是更好的類似物。我們對產品發布後以及第一季的進展感到非常滿意。然後我可能會把它傳給弗蘭克，添加一些顏色。

Yes. Hi, Larry. I'll just say that, what we - we said in prior quarters' remains true, that we see a high unmet need. This is a population that does not have a good treatment option. And tumor treating fields is perceived as bringing clinical value, to that patient population. And we're seeing in the numbers that we do have 90% of the patients, who have been previously treated, with immune checkpoint inhibitors. And that again gives us real confidence that, there's a big population out there to go and pursue.

是的。你好，拉里。我只想說，我們在前幾個季度所說的仍然是正確的，我們看到了很大的未滿足需求。這類人沒有良好的治療選擇。腫瘤治療領域被認為能為患者族群帶來臨床價值。我們從數據中看到，90% 的患者之前都接受過免疫檢查點抑制劑治療。這再次給了我們真正的信心，讓我們相信還有大量的人口可以追求。

And just one kind of story I'll add, to give color to what Ashley said about, the fact that the community does at least know tumor treating fields. We were able to have Optune Lua added to the drop down ordering menu, at one of the large in the electronic medical record, of one of the largest private practices in the U.S. And that - when we did that for GBM, it took us about five years to get to that point, and it took us about five months in the lung cancer launch.

我只想補充一個故事，來佐證阿什利所說的事實，即社區至少了解腫瘤治療領域。我們能夠將 Optune Lua 添加到下拉訂購菜單中，這是美國最大的私人診所之一的電子病歷中的一個大型菜單。當我們為 GBM 做到這一點時，我們花了大約五年時間才達到這一點，而在肺癌治療中我們只花了大約五個月的時間。

That's very helpful. And then switching gears to PANOVA-3, Ashley maybe help set expectations for the presentation at ASCO, in addition to the overall survival curves. What data do you think will be important to physicians such as response rate, percent of patients who become surgically operable? And how are you going to address pushback from academic physicians that you use [Gem Abraxane] in the control arm, and not FULFIRINOX in the control arm? Thanks.

這非常有幫助。然後切換到 PANOVA-3，除了整體生存曲線之外，Ashley 可能還有助於設定 ASCO 演示的期望。您認為哪些數據對醫師來說很重要，例如反應率、可進行手術的患者百分比？您將如何應對學術醫生的反對，即您在對照組中使用 [Gem Abraxane]，而不是在對照組中使用 FULFIRINOX？謝謝。

Great. So I will just remind everybody that, we were very pleased to have our late breaking abstract accepted, for oral presentation on Saturday afternoon at ASCO services. Really prime podium time for our PANOVA-3 data set presentation. And I'll just put another plug in that. We are planning on hosting an investor event that Saturday evening. So hope to see many of you all in Chicago.

偉大的。因此，我只想提醒大家，我們很高興我們的最新摘要被接受，並在週六下午在 ASCO 服務處進行口頭報告。這確實是我們 PANOVA-3 資料集示範的黃金時機。我只需再插入另一個插頭即可。我們計劃在周六晚上舉辦一場投資者活動。希望在芝加哥見到你們。

And I think, you could expect what you would always expect from the first presentation of primary data. You'll get the full data set, you'll get the full demographic breakdown, you'll see the Kaplan-Meier curves for the first time. We know that this trial was successful. We know that we extended survival by two months, which is a meaningful extension in locally advanced pancreatic cancer.

我認為，您可以從原始數據的首次呈現中獲得您一直期望的結果。您將獲得完整的資料集，您將獲得完整的人口統計細目，您將第一次看到 Kaplan-Meier 曲線。我們知道這次試驗是成功的。我們知道我們將生存期延長了兩個月，這對於局部晚期胰腺癌來說是一個有意義的延長。

And you'll just see the full detail, including key secondary endpoints presented by Dr. Picozzi on stage. I think Larry, in terms of questions that we're going to get around this trial, I think there's always questions that I would say, this is a very clean trial in a space with significant unmet need. Our engagement with the scientific committees, and with the investigators so far has been one of real excitement.

您將看到完整的細節，包括 Picozzi 博士在舞台上展示的關鍵次要終點。我認為，拉里，就我們將要圍繞這次試驗提出的問題而言，我認為總會有一些問題，我會說，這是一次非常乾淨的試驗，在一個存在大量未滿足需求的領域。到目前為止，我們與科學委員會和研究人員的合作令人興奮。

It is extremely rare for a pancreatic cancer Phase 3 trial to hit its endpoint. And there is a lot of interest in understanding how we can use tumor treating fields, both in this locally advanced setting, in combination with Gem Abraxane, and where we can take the research from here.

胰臟癌 III 期試驗達到終點的情況極為罕見。人們對如何使用腫瘤治療場（既在局部先進的環境中，又與 Gem Abraxane 結合使用）以及從哪裡進行研究非常感興趣。

So I would say we're confident that this is a community, both on the academic and the commercial side that is eager to engage in a discussion, on how they can extend survival for pancreatic cancer. And we look forward to sharing the data with everybody at ASCO.

因此我想說，我們相信，無論是學術界還是商業界，這個團體都渴望參與討論如何延長胰臟癌患者的生存期。我們期待與 ASCO 的每個人分享這些數據。

All right, thanks so much.

好的，非常感謝。

Jonathan Chang with Leerink Partners.

Leerink Partners 的 Jonathan Chang。

This is [Yiwen] on for Jonathan. Thanks for taking our questions, and congrats on the PANOVA-3 getting accepted as a late breaker at ASCO. So our question is how should we be thinking about the potential read through, of the positive PANOVA-3 results to the Phase 2 PANOVA-4, which is in the metastatic pancreatic cancer setting? And how are you thinking about the local versus systemic control TTFields and the potential mechanism? Thank you.

這是 [Yiwen] 為 Jonathan 主持的。感謝您回答我們的問題，並祝賀 PANOVA-3 被 ASCO 接受為晚期突破試驗。所以我們的問題是，我們應該如何考慮將 PANOVA-3 的陽性結果對轉移性胰腺癌環境中的第 2 階段 PANOVA-4 進行潛在的解讀？您如何看待局部與系統控制 TTFields 以及潛在機制？謝謝。

Thanks for the question. I'm actually going to hand that over, as how we think about local versus metastatic to Nicolas in a minute. But it is a good reminder for everybody that, we do have another data set reading out next year, the first half of next year in metastatic pancreatic cancer, which is the combination of tumor treating fields, Gem Abraxane and atezolizumab in metastatic pink, which looks at the potential to again extend survival, when we combine with an immune checkpoint inhibitor.

謝謝你的提問。我實際上將在一分鐘內將我們如何看待局部與轉移性這個問題交給 Nicolas。但這提醒大家，我們明年，也就是明年上半年，還會有另一組關於轉移性胰腺癌的數據集，這是腫瘤治療領域、Gem Abraxane 和轉移性粉紅色的 atezolizumab 的組合，當我們與免疫檢查點抑製劑結合時，它有望再次延長生存期。

So we're very excited about this data set. I think the perhaps it's always a little dangerous to do read throughs, but perhaps the more interesting read through is the combination of the ICI, and tumor treating fields in lunar, where we saw significant immune activation and a really profound overall survival benefit. So we're very excited to see this data, and I think the community is as well. But in terms of what it looks like, we'll have to wait for the trial to read out. Anything you would add, Nicolas?

所以我們對這個數據集感到非常興奮。我認為，進行通讀可能總是有點危險，但也許更有趣的通讀是 ​​ICI 和月球腫瘤治療場的結合，我們看到了顯著的免疫活化和真正顯著的整體生存益處。所以我們很高興看到這些數據，我想社區也是如此。但具體結果如何，還需等待審判結果公佈。尼可拉斯，您還有什麼要補充的嗎？

Yes. Thank you, Ashley. I think it's very important to remind everyone that pancreatic cancer, especially locally advanced pancreatic cancer, has been known in clinical research as one of the biggest graveyards. I mean all the trials so far, mainly Phase 2 trials have failed. So here we're presenting and we will present, the first Phase 3 that is positive and shows in the full pathogen. You'll see that a real benefit to the patient.

是的。謝謝你，阿什利。我認為有必要提醒大家，胰臟癌，特別是局部晚期胰臟癌，在臨床研究中被認為是最大的墳墓之一。我的意思是迄今為止的所有試驗，主要是第二階段試驗都失敗了。因此，我們在這裡展示並將展示第一階段呈陽性並顯示完整病原體的情況。您會發現這對患者確實有益。

Now when we look at the big picture, of course, it's also about the metastatic status of that disease. And thank you for reminding us that PANOVA-4 does combine a checkpoint inhibitor in metastatic disease, and we do have some indications that we have some impact outside of the treatment field. So I'm looking in a very positive way towards those results for next year, and I'm thrilled with the community to start, or to open up a new modality for those patients, who are really in need.

現在，當我們從整體來看時，當然也需要考慮該疾病的轉移狀態。感謝您提醒我們，PANOVA-4 確實結合了轉移性疾病的檢查點抑制劑，而且我們確實有一些跡象表明我們在治療領域之外產生了一些影響。因此，我對明年的結果非常樂觀，我很高興社區能夠為那些真正需要的患者開啟或開闢一種新的治療模式。

Thank you.

謝謝。

Jason Bednar with Piper Sandler.

傑森貝德納 (Jason Bednar) 和派珀桑德勒 (Piper Sandler)。

Good morning. Thanks for taking the questions and all the extra color today on non-small cell lung cancer and congrats on the recent developments. Why don't I focus maybe with the early experience, and that lung cancer indication and following on Larry's question, maybe asking in a bit of a different way with 93 unique prescribers right now, it's a good number. Can you talk about how you see the growth of your prescribers going forward? I hear you on the medtech like ramp being fairly linear, but with that in mind do you have a total target prescriber base you're going after? What are doctors waiting to see before having greater confidence, also in writing prescriptions versus the roughly one per quarter, we saw here in the first quarter?

早安.感謝您今天回答問題以及有關非小細胞肺癌的所有額外信息，並祝賀最近的進展。我為什麼不把重點放在早期經驗和肺癌指徵上，並回答拉里的問題，也許可以用稍微不同的方式詢問，目前有 93 位獨特的處方者，這是一個很好的數字。您能談談您如何看待未來處方藥數量成長嗎？我聽說您在醫療技術領域的進展相當線性，但考慮到這一點，您是否有一個要追求的總體目標處方者基礎？與第一季大約每季開一張處方相比，醫生們在更有信心開處方之前，還在等待什麼呢？

Hi, Jason, this is Frank. Thank you for the question. And what I'd say is that, we keep going back to our message of right physician, right patient and right time. And that is important for us, because - we do believe in introducing a new device based treatment to the medical oncology profession, that the first experience is really critical. And along those lines, I think the number that I'd highlight in what we released today, is to look at the fact that the stage, or the line of therapy right now has been second and third line majority.

嗨，傑森，我是法蘭克。謝謝你的提問。我想說的是，我們不斷重申正確的醫生、正確的病人和正確的時間這項原則。這對我們來說很重要，因為 - 我們確實相信向腫瘤醫學界引入一種新的基於設備的治療方法，第一次的體驗非常關鍵。沿著這個思路，我認為今天發布的數字中我要強調的是，目前的治療階段或治療路線大多數是二線和三線。

And that's really what we've been focused on, so that we're getting those right patients where we're going to have enough time, to deliver quality therapy to them. And then ensure that that physician is then interested, and motivated to put the next patient on therapy. So that's a bit of a way of saying that, looking at the targeted prescribers list, we do obviously have a targeted prescribers list.

這正是我們一直在關注的重點，這樣我們就能找到合適的患者，並有足夠的時間為他們提供高品質的治療。然後確保該醫生感興趣並有動力為下一位患者進行治療。所以，從某種程度上來說，透過查看目標處方者名單，我們顯然有一個目標處方者名單。

We do have sort of a set, number that we're targeting overall. But this sort of the pace at, which that will play out is really going to be in a way that we do know that, we're not going to go wide and have sort of physicians who have, maybe put people on for salvage therapy, don't really know us, don't understand the therapy. That's not something that we'll do this year.

我們確實有一個總體目標數字。但是，我們知道，這種進展的速度確實會以某種方式進行，我們不會廣泛開展，也不會讓那些可能為患者安排挽救性治療的醫生真正了解我們，不懂得這種療法。這不是我們今年會做的事情。

We're really going to be very much focused on do, we have the right patients, did we deliver the right first experience? And along with that though, did we drive growth? Are we driving up the number of prescribers? And so you did see that, you did see that in the sense that we moved from, we didn't give the number last quarter, but we have moved up to 60% are now new prescribers to tumor treating fields. And I think that number, will continue to increase as we move forward.

我們確實會非常關注我們是否擁有合適的患者，我們是否提供了正確的初次體驗？但同時，我們是否推動了成長？我們是否會增加開處方者的數量？所以你確實看到了，你確實看到了，從某種意義上說，我們沒有給出上個季度的數字，但現在我們已經上升到 60% 是腫瘤治療領域的新處方者。我認為，隨著我們不斷前進，這個數字還會繼續增加。

Okay. Thanks Frank. Maybe I'll one follow-up to there. And then a separate question. If we think out a year or two from now, does the growth and long come more from growing the prescriber base or getting those, the current prescribers that you have, going deeper with those prescribers, just trying to understand the different levers there. And then separately, what's the status with getting long added to NCCN guidelines. And how important is that to the commercial efforts?

好的。謝謝弗蘭克。也許我會跟進一下。然後是一個單獨的問題。如果我們考慮一兩年後的情況，那麼成長和長期是否會更多地來自於擴大處方者基礎，還是來自於獲得現有的處方者，與這些處方者進行更深入的交流，只是試圖了解那裡的不同槓桿。然後另外，加入到 NCCN 指南的狀態如何。這對於商業努力有多重要？

Yes, absolutely. So on the first question, it will be a mix of both that we do want to get call it better depth inside practices that, we are routinely being prescribed. We will also need to grow the prescriber base. Medical oncology as a profession, is significantly larger than the group we deal with for neuro oncology. So there's going to have to be growth.

是的，絕對是。因此，對於第一個問題，這將是兩者的結合，我們確實希望在日常實踐中獲得更好的深度。我們還需要擴大處方者基礎。醫學腫瘤學作為一門專業，其規模比我們處理的神經腫瘤學群體大得多。因此必須要有成長。

But what I will say to highlight on the depth issue, one of the top five largest academic oncology centers in the United States has now put on six patients, for the lung cancer launch. So we are seeing that interest, where we can get a practice to really adopt. And then on the NCCN, NCCN guidelines are absolutely the gold standard in terms of determining clinical practice for non-small cell lung cancer.

但我想強調的是，關於深度問題，美國五大學術腫瘤中心之一目前已為肺癌啟動計畫安排了六名患者。因此，我們看到了這種興趣，我們可以真正採取這種做法。然後就 NCCN 而言，NCCN 指南絕對是確定非小細胞肺癌臨床實踐的黃金標準。

We are very focused on making sure, we provided the community with enough education that tumor treating fields will be reviewed at the upcoming July meeting, for the NCCN.

我們非常注重確保我們為社區提供足夠的教育，以便在即將於 7 月舉行的 NCCN 會議上審查腫瘤治療領域。

Very helpful. Thank you.

非常有幫助。謝謝。

(Operator Instructions)

（操作員指示）

Vijay Kumar with Evercore ISI.

Evercore ISI 的 Vijay Kumar。

Hi guys, thanks for taking my question. Actually, maybe on the first one, high level, the lung prescriptions within metastatic setting, looks like it went up 40 since the last update we gave. Is that 40 prescriptions per quarter at this stage of the launch phase? Is that a positive number? Like what is the right context to think about that prescription ramp?

大家好，感謝你們回答我的問題。實際上，也許在第一個高水準上，轉移性環境中的肺處方似乎自我們上次更新以來增加了 40。在發布階段的這個階段，每季的處方量是 40 張嗎？這是一個正數嗎？思考處方坡道的正確背景是什麼？

Yes, I'll just read. Yes is the short answer. So 92 prescriptions in the quarter, which is very much in line with our expectations. And I'll just reiterate some of the points that Frank has brought up that, we are focused on the right physician, the right patient at the right time in this launch trajectory to make sure that that first experience that, the physician has is one that is well informed with education.

是的，我只是讀。簡短的回答是「是」。因此本季的處方數量為 92 張，非常符合我們的預期。我只想重申弗蘭克提出的一些觀點，我們專注於在這一發射軌跡上在正確的時間找到正確的醫生、正確的患者，以確保醫生的第一次體驗是經過充分教育的。

Which is delivered to a patient that has the best chance, to productively engage with this therapy, and at the right time so that we're able to get paid for it, as we build up the reimbursement support. So yes is the short answer. We are pleased with the traction we've seen so far, and again we'll look forward to providing further updates.

我們將在最合適的時間將藥物提供給最有可能有效參與治療的患者，以便我們能夠在建立報銷支持的同時獲得報酬。所以簡短的回答是「是」。我們對迄今為止所取得的進展感到滿意，並再次期待提供進一步的更新。

But everything that we see out in field so far, points to the fact that there is an unmet need here, that physicians are willing to engage in a new therapy, to fill that unmet need, and that they're excited about the potential to extend survival with Optune Lua.

但到目前為止，我們在該領域看到的一切都表明，該領域存在未滿足的需求，醫生願意參與新的治療方法來滿足這一未滿足的需求，並且他們對使用 Optune Lua 延長生存期的潛力感到興奮。

Understood. And then on CE Mark in Germany. What's the reimbursement pathway in Germany? Is this on a case-by-case basis, or do you have broader reimbursement? And how would revenue recognition work in Germany?

明白了。然後是德國的 CE 標誌。德國的報銷途徑是怎樣的？這是根據具體情況而定的嗎，還是有更廣泛的報銷？那麼，德國的收入確認是如何運作的呢？

Yes, no, it's a great question. So it is on case-by-case at the beginning. The U.S. and Germany are the two markets, where we can launch on a case-by-case basis. I will remind everybody that we know how to do this, case-by-case reimbursement and we're actually controlling the flow of patients, such that we put patients on that we believe that we can win reimbursement for on a case-by-case appeal.

是的，不，這是一個很好的問題。所以一開始就是根據具體情況來決定的。美國和德國是兩個我們可以逐案推出產品的市場。我要提醒大家，我們知道如何做到這一點，逐案報銷，我們實際上正在控制病人的流量，這樣我們就會把病人安排在我們認為可以透過逐案上訴獲得報銷的病人身上。

That's the right patient element of that right patient, right physician, right time mantra that we just walked through. But so in Germany, we will be following a similar path in the U.S., it is more attuned to the commercial side of the U.S. market than it is the Medicare side of the U.S. market. But we think we'll be able to get to successful resolution of those appeals in a more standard predictable reimbursement rate over the course of the year.

這就是我們剛剛講過的「正確的病人、正確的醫生、正確的時間」的正確病人要素。但在德國，我們將遵循與美國類似的道路，它更適合美國市場的商業方面，而不是美國市場的醫療保險方面。但我們認為，我們將能夠在一年內以更標準的可預測的報銷率成功解決這些上訴。

Understood. And Christoph, maybe a couple of modeling questions for you. France was really strong. I thought France was maybe comments suggested perhaps we're a peakish stage in France. Maybe talk about France opportunity. And overall when you look at the revenue picture in the quarter, any one-offs, any CMS back there, et cetera, that we should back up?

明白了。克里斯托夫，我想問你幾個建模問題。法國確實很強大。我認為法國也許有評論表明我們可能正處於法國的巔峰階段。也許可以談談法國的機會。總體而言，當您查看本季的收入情況時，是否有任何一次性支出、任何 CMS 等等是我們應該支持的？

Yes. So first I point to, I mean we had 12% revenue growth in the quarter, and we had active patient growth of 11%. When you look at, what really drives revenue, it's Optune Gio that where we had 9% revenue growth. So basically that gives you what were growth from price. Now France was very strong, but also when you look at the quarterly revenue projection, or revenue evolution of prior year.

是的。首先我要指出的是，本季我們的營收成長了 12%，活躍患者成長了 11%。如果你看一下，你會發現真正推動營收成長的是 Optune Gio，它為我們帶來了 9% 的營收成長。所以基本上這就告訴你價格的成長情況。現在法國非常強大，但當你查看季度收入預測或上一年的收入變化時也是如此。

Q1 was the lowest quarter in prior year, and that we had fairly significant growth in Q2. So we would expect the growth in France to slow down, as we progress through the year. And from a big picture perspective, what we said in our last call is that, for this year we expect growth in the low to mid-single-digit range, and that's still what we would expect for the full year.

第一季是去年同期最低的季度，而第二季度則實現了相當顯著的成長。因此，我們預計，隨著時間的推移，法國的經濟成長將會放緩。從整體來看，我們在上次電話會議上表示，我們預計今年的成長率將在低至中等個位數的範圍內，這也是我們對全年的預期。

Understood. And then maybe one last one for you on with the updated tariff picture. Are we looking at gross margins of low 70s, or are we looking at mid-70s gross margins?

明白了。最後，我們再向您介紹更新後的關稅狀況​​。我們正在尋找 70% 以下的毛利率，還是 70% 左右的毛利率？

Yes. So as a reminder, what we said in our last call is that for 2025, we were looking at gross margins in the low 70s for 2025, and that at the time there were two headwinds. One, is the launch in lung where we treat on label patients, before having reimbursement. So essentially we have the cost, before we have the revenue. And then the other headwind, is the rollout of the HFE array, which is more costly than the old one at this point in the life cycle of the array.

是的。因此，提醒一下，我們在上次電話會議上說過，對於 2025 年，我們預計毛利率將在 70% 出頭，而當時面臨兩大不利因素。一是，我們在肺癌領域推出該藥物，在獲得報銷之前對符合標籤要求的患者進行治療。因此，本質上，我們先有成本，然後才有收入。另一個不利因素是 HFE 陣列的推出，在陣列的生命週期中，它比舊陣列的成本更高。

Now there's a third headwind that came to it, which is now the tariffs. And big picture how we think about it, is that our gross margin assumption for this year has not changed. We are actually ahead of plan with our cost reduction journey on the HFE array, so that we believe we can offset a large impact from the tariffs, with being ahead of cost reductions on the HFE array. So gross margin picture for the year hasn't changed to what we said before.

現在又出現了第三個阻力，那就是關稅。從總體上看，我們對今年毛利率的假設沒有改變。實際上，我們在 HFE 陣列上的成本削減計劃已經提前了，因此我們相信，透過提前削減 HFE 陣列的成本，我們可以抵消關稅帶來的巨大影響。因此，今年的毛利率情況與我們之前所說的一樣，沒有變化。

That's helpful. Thank you guys.

這很有幫助。謝謝你們。

Jessica Fye with JPMorgan.

摩根大通的傑西卡費伊 (Jessica Fye)。

Hi guys, good morning. Thanks for taking my questions. I had a few. I'll just kind of up front, just like a math question, can you walk through why you would still owe an increase of $8 million in tariffs if the pause extends through year end, but it only goes up to $11 million if it ends after 90 days? Second, I know it's early. I'm curious if you're getting any early read in lung, around how long patients are staying on TTF therapy and if you think that'll track, similarly to what you saw in the LUNAR trial. And then lastly, can you just touch on how enrollment is going in LUNAR-2 and LUNAR-4, and when we might expect enrollment completion there? Thank you.

大家好，早安。感謝您回答我的問題。我吃了一些。我先問一個數學問題，您能否解釋一下為什麼如果暫停期持續到年底，您仍然需要增加 800 萬美元的關稅，但如果暫停期在 90 天後結束，則關稅只會增加到 1100 萬美元？第二，我知道現在還早。我很好奇您是否對肺部有任何早期了解，關於患者接受 TTF 治療的時間有多長，以及您是否認為這會有追蹤效果，類似於您在 LUNAR 試驗中看到的情況。最後，您能否簡單介紹一下 LUNAR-2 和 LUNAR-4 的招生情況，以及預計何時完成招生？謝謝。

Yes, maybe to the first one on tariffs. Look, I think what we also said in the call, is the primary impact on the array side is from importing arrays from Israel to the U.S. The tariff during the pause is 10%. After that would be 7%. So it's a step up, but it's not a huge step up. And that basically explains why there is some difference, but not a huge difference.

是的，也許是第一個關於關稅的問題。看，我想我們在電話會議中也說過，對陣列方面的主要影響是從以色列進口陣列到美國。暫停期間的關稅為 10%。之後將是7%。所以這是一個進步，但不是一個巨大的進步。這基本上解釋了為什麼會有一些差異，但差異並不大。

Hi. And with respect to the treatment duration for patients in the U.S. on the non-small cell lung cancer launch, I would just say first that, if you think about the time that we've had since launch, it's still very short, and the first cohort of patients is just sort of crossing into that time period, where we would be able to measure. But I can say that so far it's in line with our expectations from LUNAR.

你好。關於美國非小細胞肺癌患者的治療時長，我首先要說的是，如果你想想我們自推出以來的時間，它仍然很短，第一批患者才剛進入那個我們能夠衡量的時間段。但我可以說，到目前為止，它符合我們對 LUNAR 的期望。

Yes, and just on LUNAR-2 and LUNAR-4. We're still in the kind of site activation, and kind of early enrollment phase of those. So I would say once we have clear line of sight to patients per site per month across our footprint, we'll provide updated guidance there. But at the moment, I would say early days on track. But not yet far enough along in enrollment to indicate timing.

是的，僅在 LUNAR-2 和 LUNAR-4 上。我們仍處於站點啟動和早期註冊階段。因此我想說，一旦我們清楚地了解了我們覆蓋範圍內每個站點每月的患者情況，我們就會在那裡提供更新的指導。但目前，我想說的是，一切都很順利。但入學情況還不夠好，無法確定具體時間。

Great. Thank you.

偉大的。謝謝。

Emily Bodnar with H.C. Wainwright.

艾蜜莉‧博德納 (Emily Bodnar) 與 H.C. 溫賴特 (H.C. Wainwright)。

Hi, good morning. Thanks for taking the questions. I got to the first one for Germany with the lung launch. If you can kind of discuss how you think about ramp up there relative to your current ramp up in the U.S. And also in terms of the initial $1.5 million that was recognized, I believe $0.7 million was for lung. How should we think about revenues in the U.S. for 2025, since it seems like you're able to get some reimbursement already? Thanks.

嗨，早安。感謝您回答這些問題。我透過肺發射到達了德國的第一艘飛船。如果您可以討論一下，相對於您目前在美國的成長，您如何看待那裡的成長？另外，就最初確認的 150 萬美元而言，我相信 70 萬美元是用於肺部的。既然看起來您已經能夠獲得一些報銷，那麼我們應該如何看待 2025 年美國的收入？謝謝。

Hi. I'll start with addressing the launch in Germany, and I'll just start by saying first that we are very pleased with the label that we've secured under the CE Mark. Once again, we have access to this broad population of patients, who have had a platinum failure in the first line. And just as in the United States, these patients in Germany have a high unmet need that we can address with high clinical value.

你好。我首先要談談在德國的發布會，首先我要說的是，我們對獲得 CE 標誌的標籤感到非常滿意。再次，我們可以接觸到這一大群在第一線治療中鉑類藥物失敗的患者。和美國一樣，德國的這些患者也存在著大量未滿足的需求，我們可以用很高的臨床價值來滿足這些需求。

So we're starting from the fact that, we think we have a big population and a good label. We also have a strong team in Germany that, has been able to promote to the MPM indication. And I think as you look at the numbers, they're relatively small, but you can see that there was a focus on MPM in the fourth quarter, and the first quarter. So the team is in the field, knows the doctors ready to go.

因此，我們從這樣一個事實出發：我們認為我們擁有龐大的人口和良好的標籤。我們在德國也有一支強大的團隊，能夠推廣到 MPM 適應症。我認為，當您查看這些數字時，它們相對較小，但您可以看到第四季度和第一季的重點是 MPM。因此，團隊已經在現場，知道醫生已經做好出發的準備。

And I think what I can say, is we're not going to provide a sort of specific direction, of targets for the year or the quarter. But I can say what Ashley said, which is Germany generally mirrors our U.S. business in terms of both, how medicine is practiced, how the reimbursement system works. And so our launch strategy will be largely the same.

我認為我可以說的是，我們不會提供具體的方向，或年度或季度的目標。但我可以像阿什利所說的那樣，德國在醫療實踐方式、報銷制度運作方式等方面與我們美國的業務大致相同。因此我們的發布策略基本上相同。

Yes. And on the other question, revenue for NSCLC, I mean, point one is it's going to be reflective of the cash collections in the period, right. And then over quarter-over-quarter it will reflect the ramp on the patient side.

是的。關於另一個問題，NSCLC 的收入，我的意思是，第一點是它將反映該期間的現金收款情況，對吧。然後，每個季度它都會反映出患者方面的上升趨勢。

But it is a good sign that, we've seen revenue come in the door. I think already. I think what we're seeing is we're able to get these bills out the door. We're able to get insurance approvals, and actually we're able to get fully through that cash collection cycle within a quarter, which is certainly promising.

但這是一個好兆頭，我們已經看到收入開始成長。我已經想到了。我認為我們所看到的是我們能夠將這些法案付諸實施。我們能夠獲得保險批准，實際上我們能夠在一個季度內完全完成現金收集週期，這當然是有希望的。

Great. Thank you.

偉大的。謝謝。

That concludes today's question-and-answer session. I'd like to turn the call back to Bill Doyle, for closing remarks.

今天的問答環節到此結束。我想把電話轉回給比爾·道爾，請他做最後發言。

Once again, I'd like to thank everyone on the call, for their interest in Novocure. I'm very pleased that after a very strong 2024, we've been able to continue that momentum into Q1, and achieve some very important milestones so far. We're delighted with the CE Mark, for non-small cell lung cancer in Europe. We're looking forward to progress in Japan, and adding that market to our trio of non-small cell lung cancer markets.

我再次感謝電話會議中的每個人對 Novocure 的關注。我很高興，在經歷了非常強勁的 2024 年之後，我們能夠將這種勢頭延續到第一季度，並且迄今為止取得了一些非常重要的里程碑。我們很高興獲得歐洲非小細胞肺癌 CE 標誌。我們期待在日本取得進展，並將該市場添加到我們的三大非小細胞肺癌市場中。

We couldn't be more pleased with our positioning at ASCO, for the presentation of the PANOVA data set, as has been mentioned several times so far, the only Phase 3 trial to be successful in the locally advanced pancreatic cancer population. And then on the regulatory front, we're pleased with the progress that we've made with both METIS and PANOVA, and we anticipate the completion of those filings, and being potentially launch ready in 2026.

我們對在 ASCO 上的定位感到非常滿意，因為展示了 PANOVA 數據集，正如迄今為止多次提到的那樣，這是唯一在局部晚期胰腺癌人群中取得成功的 3 期試驗。在監管方面，我們對 METIS 和 PANOVA 的進展感到滿意，我們預計這些申請將完成，並可能在 2026 年準備好推出。

So it is exciting at Novocure, we're well into the pivot that we've described, as we take the company from our solid base in GBM into the next chapter, where we're an international multi-indication oncology company. And again, thank you for your continued interest in Novocure.

因此，Novocure 令人興奮不已，我們已順利進入我們所描述的轉折點，我們將帶領公司從 GBM 的堅實基礎邁入新的篇章，成為一家國際多適應症腫瘤學公司。再次感謝您對 Novocure 的持續關注。

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

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。