Novocure Ltd (NVCR) 2025 Q2 法說會逐字稿

Good day. Thank you for standing by. Welcome to Novocure's second-quarter 2025 earnings conference call. (Operator Instructions) Please note that today's conference may be recorded.

再會。感謝您的支持。歡迎參加 Novocure 2025 年第二季財報電話會議。（操作員指示）請注意，今天的會議可能會被錄音。

I will go ahead the conference over the speaker host Ingrid Goldberg. Please go ahead.

我將在演講主持人 Ingrid Goldberg 的主持下繼續主持會議。請繼續。

Good morning and thank you for joining us to review Novocure's second-quarter 2025 performance. I'm 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. For your reference, slide accompanying this earnings release can be found on our website www.novocare.com on the Investor Relations page under Quarterly Reports.

早安，感謝您與我們一起回顧 Novocure 2025 年第二季的業績。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。我們的執行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.novocare.com 的「季度報告」下的「投資者關係」頁面上找到。

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

在我們開始之前，我想提醒您，我們在本次電話會議中的討論將包括前瞻性陳述，實際結果可能與這些陳述中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，並且它們在我們向美國證券交易委員會提交的文件中不時描述。除非法律要求，否則我們無意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. Reconciliations of non-GAAP to GAAP financial measures are included in our press release, earning slides, and 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'll open the line for your questions.

在適當的情況下，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，並且最能反映我們的業務產生的財務價值。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. At Novocure, our mission is to extend survival for patients diagnosed with some of the most aggressive forms of cancer through the development of Tumor Treating Fields therapy. This quarter, we grew our commercial business and advanced our efforts to bring Tumor Treating Fields therapy to new patient populations. With the first half of 2025 complete, I am pleased to report we are making good progress in our clinical, regulatory, and commercial milestones.

謝謝你，英格麗德，早安。在 Novocure，我們的使命是透過開發腫瘤治療場療法來延長被診斷出患有某些最具侵襲性的癌症的患者的生存期。本季度，我們擴大了商業業務，並加強將腫瘤治療電場療法推廣給新的患者群體。隨著 2025 年上半年的結束，我很高興地報告，我們在臨床、監管和商業里程碑方面取得了良好進展。

This morning, we will provide details concerning recent PANOVA-3 data presentations at two key medical conferences and we will review the next steps for our upcoming regulatory submissions of PANOVA-3 and METIS. We will also discuss our commercial performance in the quarter. And to close, we will review our quarterly financials and open the line for Q&A.

今天上午，我們將提供有關最近在兩個重要醫學會議上 PANOVA-3 數據演示的詳細信息，並將審查即將提交的 PANOVA-3 和 METIS 監管申請的後續步驟。我們也將討論本季的商業表現。最後，我們將回顧我們的季度財務狀況並開放問答熱線。

While our commercial teams pursue greater penetration and improved indications, we are working intensely to gain approvals in new indications. This quarter, we took important steps towards approval in pancreatic cancer. The five-year survival rate for patients diagnosed with pancreatic cancer is only 13%. And pancreatic cancer is often associated with debilitating pain, for which patients are quickly escalated to high doses of pain medications. Addressing these needs sets a high threshold for success in pancreatic cancer trials.

我們的商業團隊追求更大的滲透率和改善的適應症，同時我們正在努力獲得新適應症的批准。本季度，我們在胰臟癌治療領域邁出了重要一步。胰臟癌患者的五年存活率僅13%。胰臟癌常伴隨劇烈疼痛，患者因此需要快速服用大劑量的止痛藥。滿足這些需求為胰臟癌試驗的成功設定了很高的門檻。

We are pleased the PANOVA-3 trial proved the benefit of TTFields therapy together with gemcitabine and nab-paclitaxel for both of these endpoints. In May, we had an exciting presence at the ASCO Annual Meeting where data from PANOVA-3 were presented during the Saturday evening pancreatic cancer plenary session. The PANOVA-3 findings were concurrently published in the Journal of Clinical Oncology, or JCO, and earned inclusion in Best of ASCO which will be highlighted at regional ASCO meetings throughout the year.

我們很高興 PANOVA-3 試驗證明了 TTFields 療法聯合吉西他濱和白蛋白結合型紫杉醇對這兩個終點都有益處。5 月份，我們在 ASCO 年會上表現出色，週六晚上的胰腺癌全體會議上展示了 PANOVA-3 的數據。PANOVA-3 的研究結果同時發表在《臨床腫瘤學雜誌》（JCO）上，並收錄在《ASCO 最佳研究》中，該研究結果將在全年的 ASCO 區域會議上重點介紹。

As a reminder, the PANOVA-3 intent-to-treat population in unresectable locally advanced pancreatic cancer patients treated with TTFields together with gemcitabine and nab-paclitaxel saw a median overall survival of 16.2 months, two months greater than the control arm. In the modified intent-to-treat population of patients who received at least one cycle of therapy, patients saw an even greater survival benefit of over three months. TTFields patients also saw a benefit in pain-free survival, with a median time to increase pain in the intent-to-treat group of 15.2 months versus 9.1 months of control group.

需要提醒的是，在 PANOVA-3 意圖治療族群中，無法切除的局部晚期胰臟癌患者接受 TTFields 合併吉西他濱和白蛋白結合型紫杉醇治療，中位總存活期為 16.2 個月，比對照組長兩個月。在接受至少一個療程治療的改良意向治療患者群體中，患者的生存獲益甚至超過三個月。TTFields 患者在無痛存活方面也有益處，意圖治療組疼痛增加的中位數時間為 15.2 個月，而對照組為 9.1 個月。

Following the presentation, session discussion, Dr. Brian Wolpin of Dana-Farber, who played the role of objective reviewer, said TTFields plus gemcitabine and nab-paclitaxel would be an appropriate option for standard of care. Dr. Eileen O'Reilly of Memorial Sloan Kettering Cancer Center commented on the JCO Editorial that Tumor Treating Fields, together with gemcitabine and nab-paclitaxel, serves as a new standard paradigm in this patient population. These physicians from two of the top academic institutions in the United States are leaders in the treatment of pancreatic cancers and notably are new to the use of TTFields therapy.

演講和會議討論結束後，擔任客觀審閱者的丹娜法伯癌症研究所 Brian Wolpin 博士表示，TTFields 聯合吉西他濱和白蛋白結合型紫杉醇將是標準治療的合適選擇。紀念斯隆凱特琳癌症中心的 Eileen O'Reilly 博士在 JCO 社論中評論說，腫瘤治療電場與吉西他濱和白蛋白結合型紫杉醇相結合，成為該患者群體的新標準範例。這兩位來自美國兩所頂尖學術機構的醫生是胰臟癌治療領域的領導人物，尤其對 TTFields 療法的使用還是很熟悉的。

The PANOVA-3 results earned a second late-breaking podium presentation at the ESMO GI Annual Congress where the quality of life data from PANOVA-3 was described in greater detail. Patients treated with TTFields and gemcitabine and nab-palitaxel saw improved global health status, significantly improved deterioration-free survival for pain and pancreatic pain, and significantly increased time to commencement of opioid use.

PANOVA-3 結果在 ESMO GI 年度大會上獲得了第二次最新突破性成果展示，會上對 PANOVA-3 的生活品質數據進行了更詳細的描述。接受 TTFields 和吉西他濱以及白蛋白結合型紫杉醇治療的患者整體健康狀況得到改善，疼痛和胰腺疼痛的無惡化生存期顯著提高，開始使用阿片類藥物的時間顯著增加。

PANOVA-3 showed TTField's ability to extend survival, preserve quality of life, and delay many of the worst symptoms associated with pancreatic cancer. These clinical outcomes underscore the importance of TTfields therapy for these patients. And given the extremely limited options for pancreatic cancer patients, the feedback from physicians, KOLs, and advocacy groups following these presentations has been overwhelmingly positive.

PANOVA-3 顯示了 TTField 能夠延長生存期、維持生活品質並延緩與胰臟癌相關的許多最嚴重症狀。這些臨床結果強調了 TTfields 療法對這些患者的重要性。鑑於胰臟癌患者的選擇極為有限，這些演講之後醫生、關鍵意見領袖和倡議團體的回饋非常正面。

Our teams are working on the FDA PMA submission for pancreatic cancer. Earlier this month, we met with the FDA for a pre-submission discussion in anticipation of submitting our full PMA package for FDA review. We expect to file the PMA with the FDA in the third quarter. Concurrently, we are working on the regulatory packages for Europe and Japan, and expect to file these prior to year end.

我們的團隊正在致力於胰臟癌的 FDA PMA 提交。本月初，我們與 FDA 進行了提交前討論，準備提交完整的 PMA 包供 FDA 審查。我們預計將在第三季向 FDA 提交 PMA。同時，我們正在製定針對歐洲和日本的監管方案，並預計在年底前提交。

Brain metastases from non-small cell lung cancer is our next potential indication. The METIS trial met its primary endpoint demonstrating a statistically significant improvement in the time to intercranial progression for patients treated with TTFields therapy and supportive care compared to patients treated with supportive care alone.

非小細胞肺癌腦轉移是我們下一個潛在適應症。METIS 試驗達到了其主要終點，顯示與僅接受支持性治療的患者相比，接受 TTFields 治療和支持治療的患者的顱內進展時間有統計學上顯著改善。

Following our initial data presentation at ASCO last year, the routine process of cleaning and qualification of the data was completed. The final analysis of the fully cleaned and qualified dataset confirmed the statistical significance of the primary endpoint, improvement in time to intercranial progression, with updated numerical outcomes.

繼去年我們在 ASCO 上進行初步資料展示之後，資料清理和鑑定的常規流程已經完成。對完全清理和合格的數據集的最終分析證實了主要終點的統計意義，即顱內進展時間的改善，並更新了數值結果。

Patients treated with TTFields therapy and supportive care exhibited a risk reduction of 28% with median time to interracranial progression of 15 months compared to 7.5 months in patients treated with supportive care alone. With a P value of 0.044. We intend to present the updated final clinical results in an upcoming medical conference early this fall and if submitted, the manuscript for publication.

接受 TTFields 療法和支持治療的患者顱內腫瘤進展風險降低了 28%，顱內腫瘤進展中位數時間為 15 個月，而僅接受支持治療的患者顱內腫瘤進展中位數時間為 7.5 個月。P值為0.044。我們計劃在今年秋初即將召開的醫學會議上公佈更新後的最終臨床結果，如果提交，還將公佈稿件以供出版。

Our teams are also working on the FDA PMA submission brain metastases from non-small cell lung cancer. We submitted the first two PMA modules in April. We will be meeting with the FDA this quarter prior to submission of the final clinical module, which is on track for submission later this year.

我們的團隊也正在致力於非小細胞肺癌腦轉移的 FDA PMA 提交。我們在四月提交了前兩個 PMA 模組。我們將於本季與 FDA 會面，然後提交最終臨床模組，該模組預計將於今年稍後提交。

For both PANOVA-3 and METIS PMA filings, We expect the 9- to 12-month review following acceptance by the FDA with potential approvals and launches to follow in 2026.

對於 PANOVA-3 和 METIS PMA 申請，我們預計 FDA 接受後將進行 9 到 12 個月的審查，並可能在 2026 年獲得批准和推出。

Our next clinical data readouts are anticipated in the first half of next year. The Phase 3 TRIDENT trial in newly diagnosed GBM studies the potential benefits of initiating TTFields therapy several months earlier in the patient's journey concurrent with chemoradiation, rather than after chemoradiation.

我們的下一次臨床數據讀數預計將在明年上半年公佈。針對新診斷的膠質母細胞瘤 (GBM) 的 III 期 TRIDENT 試驗研究了在患者治療過程中與放化療同時（而不是在放化療之後）提前幾個月開始 TTFields 治療的潛在益處。

PANOVA-4 is a Phase 2 trial that adds the immunotherapy atezolizumab to TTFields, gemcitabine, and nab-paclitaxel in the metastatic pancreatic cancer setting. Both trials are fully enrolled, and we look forward to sharing updates in the near future.

PANOVA-4 是一項 2 期試驗，將免疫療法阿特珠單抗添加到轉移性胰腺癌環境中的 TTFields、吉西他濱和白蛋白結合型紫杉醇中。兩項試驗均已全部報名，我們期待在不久的將來分享最新消息。

With that, I'll turn the call over to Ashley to review our commercial progress in the quarter.

說完這些，我將把電話轉給阿什利，讓他回顧我們本季的商業進展。

Thank you, Bill. We are squarely focused on execution. And I am proud of what the team has delivered so far this year. We have reached multiple milestones on our paths to bring Tumor Treating Fields to more patients and have additional catalysts on the horizon.

謝謝你，比爾。我們專注於執行。我為團隊今年迄今所取得的成績感到自豪。我們在將腫瘤治療電場帶給更多患者的道路上已經達到了多個里程碑，並且即將出現更多的催化劑。

One of our key areas of focus is the Optune Lua launch in non-small cell lung cancer. In the second quarter, we received 121 prescriptions for non-small cell lung cancer.,106 in the US, and 15 in Germany, which launched following receipt of the CE mark on April 22 of this year. We ended the period with 137 Optune Lua patients globally, 94 from non-small cell lung cancer and 43 from MPM.

我們的重點領域之一是 Optune Lua 在非小細胞肺癌領域的應用。在第二季度，我們收到了 121 張非小細胞肺癌處方，其中美國有 106 張，德國有 15 張，該產品於今年 4 月 22 日獲得 CE 標誌後上市。截至本期結束時，我們在全球共有 137 名 Optune Lua 患者，其中 94 名患有非小細胞肺癌，43 名患有 MPM。

Importantly, we are beginning to build reimbursement experience and recognize $2.4 million in net revenues from Optune Lua in the quarter, of which, $1.1 million was from non-small cell lung cancer.

重要的是，我們開始累積報銷經驗，並在本季確認了來自 Optune Lua 的 240 萬美元淨收入，其中 110 萬美元來自非小細胞肺癌。

We are pleased that many of the launch scenes we described last quarter have continued in the US. In Q2, we had 75 unique prescribers of Optune Lua, 41 of those physicians were entirely new to Tumor Treating Fields therapy, while 34 had previously prescribed. This shows a healthy mix of physicians recognizing the clinical benefit and trying Tumor Treating Fields for the first time and repeat prescribers.

我們很高興看到上個季度描述的許多發布場景在美國得以延續。在第二季度，我們有 75 位 Optune Lua 的獨特處方者，其中 41 位醫生是第一次接觸腫瘤治療場療法，而 34 位之前曾開過處方。這表明，醫生中既有認識到臨床益處的醫生，也有首次嘗試腫瘤治療電場療法的醫生，以及重複開處方的醫生。

Additionally, we continue to see the full label utilized with 58% prescriptions written together with immune checkpoint inhibitors and 42% with docetaxel. Importantly, over 93% of the patients prescribed Optune Lua with an ICI had previous ICI exposure, validating the strong demand and physician comfort with continued ICI use post platinum failure.

此外，我們繼續看到全標籤使用，其中 58% 的處方與免疫檢查點抑制劑一起開具，42% 的處方與多西他賽一起開立。重要的是，超過 93% 接受 Optune Lua 和 ICI 治療的患者之前均有 ICI 暴露史，這證實了鉑類藥物失敗後繼續使用 ICI 的需求強勁且醫生感到安心。

One theme we have observed since launch is that prior physician experience to Tumor Treating Fields matters, whether that's firsthand prescribing Optune Gio in GBM or Optune Lua for MPM, or through access to a colleague with Tumor Treating Fields experience.

自推出以來，我們觀察到的一個主題是，醫生先前對腫瘤電場治療的經驗很重要，無論是親自為 GBM 開出 Optune Gio 處方，還是為 MPM 開出 Optune Lua 處方，還是透過接觸具有腫瘤電場治療經驗的同事。

Physicians are excited by the clinical outcome seen in the LUNAR trial. However, some physicians have questions on how to incorporate Tumor Treating Fields into their daily practices. We answered the same questions when we introduced Tumor Treating Fields to the GBM community.

醫生們對 LUNAR 試驗的臨床結果感到非常興奮。然而，一些醫生對於如何將腫瘤治療場融入日常實踐中存在疑問。當我們向膠質母細胞瘤 (GBM) 社區介紹腫瘤治療場時，我們回答了相同的問題。

With this in mind, we have been cultivating peer-to-peer connections so practitioners new to Tumor Treating Fields can access physicians with years of Optune Gio experience. We have seen promising feedback from these peer-to-peer conversations so far and believe continuing to foster these relationships will pay dividends as new indications come to the medical community in the future.

考慮到這一點，我們一直在培養點對點聯繫，以便腫瘤治療場的新從業者可以接觸到具有多年 Optune Gio 經驗的醫生。到目前為止，我們已經從這些同儕對話中看到了令人鼓舞的回饋，並相信隨著未來醫學界出現新的跡象，繼續培養這些關係將會帶來回報。

We have also learned that many physicians view the best use case of Optune Lua as a replacement for platinum chemo at the first sign of radiological progression, rather than explicitly a transition to second line treatment. This represents the smoldering progression population we have referenced throughout our market research.

我們也了解到，許多醫生認為 Optune Lua 的最佳用途是在出現放射學進展的第一個跡象時取代鉑化療，而不是明確過渡到二線治療。這代表了我們在整個市場研究過程中所提到的蓬勃發展的人口。

With this in mind, we are tweaking the physician messaging around Optune Lua to a post platinum option, rather than explicitly second line therapy, to better align with the way doctors view the patient treatment journey.

考慮到這一點，我們正在調整醫生關於 Optune Lua 的信息，將其作為鉑金治療後的選擇，而不是明確的二線治療，以更好地符合醫生看待患者治療過程的方式。

Moving outside of the US, in late April, we received the CE mark for non-small cell lung cancer and launched in Germany with 15 prescriptions in the quarter. We are pleased with the early interactions with prescribers, especially pulmonologists, to take an outsized role in non-small cell lung cancer treatment in Germany compared to the US. Interest from physicians has been high, and our sales teams have been able to get on calendars swiftly. We also see similar dynamics of broad label usage and prior ICI exposure in Germany, as we have seen in the US.

走出美國，我們於 4 月底獲得了非小細胞肺癌的 CE 標誌，並在德國推出了該產品，本季已開出 15 張處方。我們很高興能夠與處方醫生，特別是肺科醫生進行早期互動，與美國相比，我們在德國的非小細胞肺癌治療中發揮了更大的作用。醫生們的興趣很高，我們的銷售團隊能夠迅速地安排好日程。我們也看到德國存在類似的廣泛標籤使用和先前 ICI 曝光的動態，就像我們在美國看到的那樣。

Japan is the next market where we expect to launch Optune Lua for non-small cell lung cancer. We are actively engaged in discussions with Japanese regulators and are hopeful we will have approval in hand in a matter of months. We believe Japan will be a strong market for non-small cell lung cancer as incidence rates are higher in Japan than in many of our other major markets.

日本是我們預計將推出用於治療非小細胞肺癌的 Optune Lua 的下一個市場。我們正在積極與日本監管機構進行討論，並希望在幾個月內獲得批准。我們相信日本將成為非小細胞肺癌的強大市場，因為日本的發生率高於我們許多其他的主要市場。

Also, single payer dynamics can expedite the revenue ramp timeline once terms are agreed, similar to what played out in our GBM launch in France over the past two years. We are doing everything in our power to expedite the approval and reimbursement processes in Japan and look forward to providing more updates later this year.

此外，一旦條款達成一致，單一付款人動態可以加快收入成長時間表，類似於我們過去兩年在法國推出的 GBM 的情況。我們正在竭盡全力加快日本的審批和報銷流程，並期待在今年稍後提供更多更新資訊。

The next step in non-small cell lung cancer will be translating demand into top line revenue growth. We have had some early success in case-by-case reimbursement submissions with over $1 million in cash recognized this quarter from non-small cell lung cancer and are actively engaged with both public and private payers in the US to reach reimbursement terms as soon as possible.

非小細胞肺癌的下一步將是將需求轉化為收入成長。我們在逐案報銷申請方面已取得一些早期成功，本季度非小細胞肺癌治療已確認超過 100 萬美元現金，並正在積極與美國公共和私人付款人合作，以盡快達成報銷條款。

Private payers are focused on updated guidelines from NCCN. The NCCN lung cancer panel met earlier this month, and we expect updated guidelines to be published this fall.

私人付款人關注的是 NCCN 的最新指南。NCCN 肺癌專家組於本月初召開了會議，我們預計更新後的指南將於今年秋季發布。

On the public side, we have submitted our package for LCD reconsideration and are now waiting to hear back from the MAC. Once an updated LCD is released and the public comments period is complete, the MAC will issue a coverage decision. There isn't a statutory timeline for review, but we estimate the review will take approximately 9 to 12 months.

在公共方面，我們已經提交了我們的方案以供 LCD 重新審議，現在正在等待 MAC 的回應。一旦更新的 LCD 發布並且公眾意見徵詢期結束，MAC 將發布覆蓋範圍決定。沒有法定的審查時間表，但我們估計審查大約需要 9 到 12 個月。

Turning to our GBM business, we continue to march higher and finished the quarter with 4,194 Optune Gio patients on therapy, a 7% increase compared to last year. Each of our key markets, the US, Germany, France, and Japan, increased their patient count year-over-year, with all our ex-US markets experiencing double-digit growth.

談到我們的 GBM 業務，我們繼續高歌猛進，本季結束時有 4,194 名 Optune Gio 患者接受治療，與去年相比成長了 7%。我們的主要市場——美國、德國、法國和日本——的患者數量均逐年增加，而我們除美國以外的所有市場都實現了兩位數的成長。

We are also starting to see early reimbursement success in Spain. While the Spanish market is fragmented, we are encouraged by the progress.

我們也開始看到西班牙早期的報銷成功。儘管西班牙市場較為分散，但我們對其進展感到鼓舞。

One of the avenues to drive GBM growth is ongoing evidence generation. This quarter, an independent retrospective study from the Mayo Clinic was published in the Journal of Clinical Neuroscience. This study followed 374 GBM patients treated at Mayo Clinic locations between 2014 and 2023. Academic centers have not historically been the highest adopters of Tumor Treating Fields therapy, so it's notable to have a leading research institution like Mayo Clinic conduct this retrospective study.

推動 GBM 成長的途徑之一是持續產生證據。本季度，梅奧診所的一項獨立回顧性研究發表在《臨床神經科學期刊》。這項研究追蹤了 2014 年至 2023 年期間在梅奧診所接受治療的 374 名 GBM 患者。從歷史上看，學術中心並不是腫瘤治療場療法的最大採用者，因此由梅奧診所這樣的領先研究機構進行這項回顧性研究是值得注意的。

In this real-world study, patients treated with Tumor Treating Fields therapy demonstrated a two-year survival rate of 58%, compared to just 41% in patients not treated Tumor Treating Fields. The Mayo study is another example of confirmatory data and reaffirms why Optune Gio is a foundational therapy for GBM patients. We believe more real-world use data from leading research centers like Mayo will be an important lever as we seek to increase adoption in academic centers.

在這項真實世界的研究中，接受腫瘤治療場治療的患者的兩年存活率為 58%，而未接受腫瘤治療場治療的患者的兩年存活率僅為 41%。Mayo 的研究是另一個驗證數據的例子，並再次證明了 Optune Gio 為何是 GBM 患者的基礎療法。我們相信，當我們尋求增加學術中心的採用率時，來自 Mayo 等領先研究中心的更多實際使用數據將成為重要槓桿。

Before I turn the call over to Christoph to review financials from the quarter, I'd like to express my gratitude to the Novocure team for their hard work during this important year. The fundamentals of our business continue to strengthen each quarter. Q2 marks the 11th consecutive quarter of active patient growth. During that time, we've had three positive Phase 3 readouts and new indications, launched our non-small cell lung cancer indication in the US and Germany, and introduced new product enhancements to improve therapy delivery and experiencie for patients and physicians.

在我將電話轉給 Christoph 回顧本季度的財務狀況之前，我想對 Novocure 團隊在這重要的一年裡所做的辛勤工作表示感謝。我們的業務基本面每季都在持續加強。第二季度是活躍患者連續第 11 季成長。在此期間，我們獲得了三個積極的 3 期數據和新的適應症，在美國和德國推出了非小細胞肺癌適應症，並推出了新的產品增強功能，以改善患者和醫生的治療服務和體驗。

Each of these achievements requires the tireless dedication of our team, and I want to applaud your efforts as we look ahead with urgency to extend survival for many more patients with some of the most aggressive forms of cancer.

每一項成就都需要我們團隊不懈的奉獻，我要為你們的努力喝彩，我們迫切地希望延長更多患有某些最具侵襲性的癌症患者的生存期。

This is a pivotal period for Novocure. With an established indication in GBM. The ongoing launch in non-small cell lung cancer and two additional launches within reach, the steps we will take this year set us up for continued growth in both the near and long term.

這是 Novocure 的關鍵時期。在 GBM 中具有既定的適應症。目前正在進行的非小細胞肺癌研發以及即將推出的另外兩項研發，我們今年將採取的措施為我們近期和長期的持續成長奠定了基礎。

With that, I will turn the call over to Christoph.

說完這些，我將把電話轉給克里斯托夫。

Thank you, Ashley. We continued our positive momentum this quarter with net revenues of $159 million, an increase of 6% from the second quarter of last year. This increase was primarily driven by year-over-year active patient growth of 7% in our GBM franchise, including double-digit growth in all our international markets. The favorable year-over-year impact from exchange rates was $3.8 million in the quarter or set by lower one-time benefits of prior period claims. We collected $2.4 million from Optune Lua claims in the quarter, including $1.1 million from non-small cell lung cancer collections in the period, compared to 1.5 million and $0.7 million in Q1.

謝謝你，阿什利。本季我們持續保持良好勢頭，淨收入達 1.59 億美元，較去年第二季成長 6%。這一成長主要得益於我們 GBM 特許經營業務的活躍患者年增 7%，其中包括我們所有國際市場的兩位數成長。本季度，匯率帶來的年比有利影響為 380 萬美元，或由前期索賠的一次性福利減少所致。本季度，我們從 Optune Lua 索賠中收取了 240 萬美元，其中包括當期來自非小細胞肺癌索賠的 110 萬美元，而第一季分別為 150 萬美元和 70 萬美元。

As a reminder, we recognize the revenue by applying estimated future collection rate at the time of billing per US GAAP standard. It will take several quarters for us to build a track record of collections to support an estimated rate to recognize revenue at billing. In the meantime, non-small cell lung cancer collections reflect approvals and positive outcomes from appeals in the court.

提醒一下，我們根據美國公認會計準則 (US GAAP) 開立發票時應用預計的未來收款率來確認收入。我們需要幾個季度的時間來建立收款記錄，以支持在計費時確認收入的估計率。同時，非小細胞肺癌的收集反映了法院上訴的批准和積極結果。

Gross margin for the second quarter was 74% compared to 77% in Q2 of 2024. This reduction was primarily driven by the rollout of our HFE rate and the continued launch of non-small cell lung cancer prior to establishment of broad reimbursement. These headwinds are consistent with previous periods, and we expect them to decrease as we lower the production costs of the HFE rate and establish reimbursement in non-small cell lung cancer.

第二季的毛利率為 74%，而 2024 年第二季的毛利率為 77%。此次減少主要是由於我們推出 HFE 費率以及在建立廣泛報銷之前繼續推出非小細胞肺癌。這些不利因素與前期一致，我們預計，隨著我們降低 HFE 率的生產成本並建立非小細胞肺癌的報銷制度，這些不利因素將會減少。

We only had a minor impact from tariffs in the quarter of $1.3 million, driven by a reduction in pre-tariff inventory in Q2. While they're still considerable uncertainty around future tariffs for import into the US, we currently do not foresee major changes from our expectations of last quarter.

本季度，我們僅受到關稅的輕微影響，為 130 萬美元，這是由於第二季關稅前庫存減少所致。儘管未來進口到美國的關稅仍然存在很大的不確定性，但我們目前預計與上個季度的預期相比不會發生重大變化。

Our most significant exposure remains the impact of (inaudible) into the US from Israel, with lesser potential impact from imports from Mexico and Europe. Our current estimates indicate that the full-year P&L impact is up to approximately $7 million, subject to timing, rates, and exemptions from these tariffs. We are continuing to actively explore avenues to minimize our tariff exposure where possible.

我們面臨的最主要風險仍然是來自以色列的進口對美國的影響（聽不清楚），而來自墨西哥和歐洲的進口的潛在影響較小。我們目前的估計表明，全年損益影響高達約 700 萬美元，具體取決於時間、稅率和這些關稅的豁免。我們將繼續積極探索各種途徑，盡可能減少關稅風險。

Moving to operating expenses. Our research and development costs in the quarter were $56 million, an increase of 2% from the second quarter of 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. States and marketing expenses in the quarter were $57 million, an increase of 1% from Q2 of last year.

轉向營運費用。我們本季的研發成本為 5,600 萬美元，比 2024 年第二季成長 2%。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。本季的州和行銷費用為 5,700 萬美元，較去年第二季成長 1%。

Incremental launch expenses for non-small cell lung cancer indication were mostly upset by lower stock-based compensation expenses. Our thoracic sales forces in the US and Germany are fully staffed, and reflected in our year-to-date operating expense. Looking ahead, We expect modest incremental expense primarily for marketing and in preparation for launch an additional countries.

非小細胞肺癌適應症的增量上市費用主要受到股票薪酬費用降低的影響。我們在美國和德國的胸腔銷售隊伍已配備齊全，並反映在我們年初至今的營運費用中。展望未來，我們預計費用將適度增加，主要用於行銷並為在更多國家推出產品做準備。

G&A expenses for the quarter were $44 million an increase of 17% from the second quarter of 2024. This increase was primarily driven by higher share-based compensation expenses and higher personnel and professional service expenses to support the non-small cell lung cancer launch and general company buildout, particularly on the enterprise technology side. Net loss for the quarter was $40 million, with a loss per share of $0.36. Adjusted EBITDA in the quarter was negative $10 million.

本季的一般及行政費用為 4,400 萬美元，較 2024 年第二季增加 17%。這一成長主要是由於股權激勵費用增加以及人員和專業服務費用增加，以支持非小細胞肺癌的推出和公司的整體建設，特別是在企業技術方面。本季淨虧損為4000萬美元，每股虧損0.36美元。本季調整後EBITDA為負1000萬美元。

Our cash and investment balance at the end of Q2 was $912 million. We have $560 million in convertible notes that will come due later this year, which we intend to retire with cash on the balance sheet.

我們第二季末的現金和投資餘額為 9.12 億美元。我們有 5.6 億美元的可轉換票據將於今年稍後到期，我們打算用資產負債表上的現金償還。

Additionally, we have given notice of intent to draw the second of four tranches of $100 million each from our credit facility, which will close on September 26, 2025. According to the terms of our credit facility, we have an obligation to draw the first two tranches. With the cash In short term investments currently on the balance sheet and funds available through our credit facility, we believe that how the capital necessary to retire the outstanding convertible notes and bridged to our next revenue streams in new indication.

此外，我們已發出意向通知，將從我們的信貸額度中提取四筆各 1 億美元的第二筆款項，該筆款項將於 2025 年 9 月 26 日結束。根據我們的信貸條款，我們有義務提取前兩筆款項。憑藉目前資產負債表上的短期投資現金和透過我們的信貸安排提供的資金，我們相信，如何獲得償還未償還可轉換債券所需的資本，並在新的跡像中過渡到我們的下一個收入來源。

As Ashley said earlier in today's call, this is our 11th traight quarter of active patient growth. With one launch ongoing and two more on the horizon, we are continuing to build momentum and deliver on the promise of our innovative therapies. We believe we have the talent, infrastructure, and financial assets in place to bring new indications to market, gain reimbursement, and reach profitability in the years to come.

正如阿什利在今天的電話會議上所說，這是我們連續第 11 個季度實現活躍患者成長。隨著一項新療法的推出以及另外兩項新療法的即將推出，我們將繼續積聚動力並兌現我們創新療法的承諾。我們相信，我們擁有人才、基礎設施和金融資產，可以在未來幾年將新適應症推向市場、獲得報銷並實現盈利。

I would like to thank you all for joining us on this journey, and we look forward to updating you on our progress later this year.

我要感謝大家與我們一起踏上這段旅程，我們期待在今年稍後向大家通報我們的進展。

I will now turn the call back to the operator for questions.

我現在將把電話轉回給接線員以回答問題。

(Operator Instructions)

（操作員指示）

Larry Biegelsen, Wells Fargo.

富國銀行的拉里·比格爾森。

Good morning, thanks for taking the question. So Ashley, the second quarter non-small cell lung cancer prescriptions in patients grew in the second quarter than Q1. And the number of prescribers actually went down. The US prescriptions increased by only 14 sequentially. So why was that? And how should we think about the ramp the rest of the year? Should we be thinking about the low end of the $5 million to $10 million range that's been discussed before for 2025? And I had one follow-up.

早上好，感謝您回答這個問題。因此，阿什利，第二季度非小細胞肺癌患者的處方量比第一季有所增加。而開處方的人數其實減少了。美國處方量較上季僅增加14%。那麼這是為什麼呢？那麼，我們該如何考慮今年剩餘時間的成長呢？我們是否應該考慮先前討論過的 2025 年 500 萬美元至 1000 萬美元範圍的低端？我還有一個後續行動。

Sure. Thanks for the question, Larry. I'll start off and then I'll ask Frank to add some additional color. So I think the theme you should take away is that the long launch is on track. We're pleased with the themes. What we're seeing is kind of a consistent ability to get into market and to educate these physicians. And I would say, we actually feel like the launch is progressing as we'd expected. And I'm quite comfortable with where expectations are on a full-year basis. And with that, I'll ask Frank to add some additional color.

當然。謝謝你的提問，拉里。我先開始，然後我會讓弗蘭克添加一些額外的顏色。所以我認為你應該記住的主題是長期啟動正在按計劃進行。我們對這些主題很滿意。我們看到的是一種持續進入市場並教育這些醫生的能力。我想說，我們確實感覺到發布會正在按照我們預期的那樣進行。我對全年的預期非常滿意。然後，我會要求弗蘭克添加一些額外的顏色。

Yeah. I would echo the note that we're pleased with the overall theme of the launch. And specifically, what I would say is that you're seeing repeat prescribers. And we've seen, in particular, prescribers who came on right right at the launch are now really building volume at their own practice. And in some instances, we've even seen physicians, and this is common for devices, have moved towards marketing access to the device in their practice in social media. And so I think, consistent with the device launch, we're getting physicians comfortable with the device. We're getting into their practice, and we're building volume.

是的。我想重申的是，我們對此次發布的整體主題感到滿意。具體來說，我想說的是，你看到的是重複開處方的醫生。我們看到，在產品發佈時就加入的處方人員現在確實在自己的診所中增加了開藥量。在某些情況下，我們甚至看到醫生（這對設備來說很常見）開始在社交媒體上行銷他們在實踐中使用該設備。因此我認為，隨著設備的推出，我們正在讓醫生對設備感到滿意。我們正在參與他們的實踐，並且正在擴大規模。

That's helpful. One follow-up on the METIS data. Bill, how different were the numbers that you disclosed this morning from what we saw at ASCO last year? And why was another analysis required? Thanks for taking the question.

這很有幫助。對 METIS 資料進行一次跟進。比爾，您今天早上揭露的數字與我們去年在 ASCO 上看到的數字有何不同？為什麼需要進行另一次分析？感謝您回答這個問題。

Sure. So let me just remind everybody what the METIS trial was studying. So non-small cell lung cancer, brain metastases are one of the really significant markers of deterioration in the patients. About 25% of patients are actually diagnosed with brain mets when they're diagnosed with cancer and at least another 25%. So this is a significant unmet need in non-small cell lung cancer. And in fact, the standard of care is stereotactic radiosurgery, followed by supportive care.

當然。因此，讓我提醒大家 METIS 試驗正在研究什麼。因此，非小細胞肺癌腦轉移是患者病情惡化的真正重要標誌之一。大約 25% 的患者在被診斷出患有癌症時實際上被診斷出患有腦轉移，另外至少還有 25% 的患者。因此，這是非小細胞肺癌領域一個尚未滿足的重大需求。事實上，標準治療是立體定位放射手術治療，然後是支持性治療。

So in METIS, we studied the addition of Tumor Treating Fields to supportive care after a stereotactic radius surgery. And the endpoint of this study was progression. All of our other trials, the endpoints are overall survival where the endpoint is very specific. And this is very common in other trials where radiographic review is part of the analysis that a first read is presented. And then through the standard cleaning of data, a final data set is provided. We're, of course, delighted that the data considered continued to be very statistically significant and very clinically meaningful.

因此，在 METIS 中，我們研究了在立體定位橈骨手術後將腫瘤治療場添加到支持性治療中。這項研究的終點是進展。我們所有其他試驗的終點都是整體存活率，其終點非常具體。這在其他試驗中非常常見，在這些試驗中，放射學審查是首次讀取的分析的一部分。然後經過標準的資料清理，提供最終的資料集。當然，我們很高興，這些數據仍然具有統計意義和臨床意義。

All right. Thank you so much for taking the questions.

好的。非常感謝您回答這些問題。

Jason Bednar, Piper Sandler.

傑森貝德納、派珀桑德勒。

Hey. Good morning. I'll double click first on the response to Larry's question on lungs, and anyone feel free to answer, but do you think there's something that you can do that increases the slope and the adoption curve and helps take those scripts and active patients higher than where we're at today. We now have a couple or four quarters of data points here to work with. I hear you (inaudible) experiences in a med tech-like launch, but maybe just talk about how you're thinking about the progression of uptake? And maybe some of your own expectations as we look out for balance this year and into the future years and feel free to respond, for US and Germany as well.

嘿。早安.我會先雙擊對 Larry 關於肺部的問題的回答，任何人都可以自由回答，但您是否認為您可以做些什麼來增加斜率和採用曲線，並有助於將這些處方和活躍患者的數量提高到比今天更高的水平。我們現在有幾個或四個季度的數據點可供使用。我聽說了您（聽不清楚）在類似醫療技術的發布中的經歷，但也許只是談談您對吸收進展的看法？當我們展望今年和未來幾年的平衡時，也許您可以提出一些自己的期望，對於美國和德國也是如此。

Yeah. Jason, this is Frank. Thank you for the question. I would just start again with the baseline for this population which is that there is a high clinical unmet need for second line treatment in Stage 4 non-small cell lung cancer. The physicians are not satisfied with what are the existing treatment options of docetaxel or docetaxel plus ramucirumab.

是的。傑森，這是法蘭克。謝謝你的提問。我將再次從該族群的基線開始，即 4 期非小細胞肺癌的二線治療存在很高的臨床未滿足需求。醫生們對於現有的多西他賽或多西他賽加雷莫蘆單抗的治療方案並不滿意。

And so we always start with the fact that we still feel very comfortable that we are going into a large market and we see that in our numbers where we see that 90% of our patients had been previously treated with immune checkpoint inhibitors. So physicians are comfortable using that full patient population with us and they're accessing both sides of our label. So that's really where we really see the opportunity to the point of steepening the curve and really driving this launch now that we have some experience.

因此，我們始終從這樣一個事實開始：我們仍然對進入一個大市場感到非常放心，而且我們從數據中看到，90% 的患者之前都接受過免疫檢查點抑制劑治療。因此，醫生們很樂意與我們一起使用全部患者群體，並且他們可以使用我們標籤的兩面。因此，我們確實看到了機會，可以進一步拉高曲線，並真正推動這次發布，因為我們有了一些經驗。

I point to refinement of our marketing messages and our refinement of our targeting of the population in that there is a very large percentage of patients who start therapy, go on a platinum therapy, and either because of side effects or adverse events, they're unable to continue the platinum therapy.

我想指出的是，我們要改進我們的行銷訊息，改進我們的目標族群，因為有很大比例的患者在開始治療、接受鉑類療法後，由於副作用或不良事件，無法繼續接受鉑類療法。

Now their disease may not have gone into a full progression. It may be, in some cases, even just a clinical progression where the patient is not feeling as well as they used to. And we're going to really lean into that message of saying once the patient is off the platinum, they're now eligible for Tumor Treating Fields.

現在他們的病情可能還沒有完全惡化。在某些情況下，這可能只是一種臨床進展，患者感覺不如以前那麼好了。我們真正想傳達的訊息是，一旦患者停止接受白金治療，他們就有資格接受腫瘤治療場治療。

And I mean, I think that's really going to be an area for success for us and that's really where we've seen some strong -- that's where we've seen physicians really building up patient volume. And so we're going to lean into that and we think we have the opportunity to grow faster.

我的意思是，我認為這確實會成為我們成功的領域，而且我們也確實看到了一些強大的醫生——我們看到醫生確實在增加患者數量。因此，我們將傾向於此，我們認為我們有機會更快地成長。

All right. Helpful. Thanks, Frank. And then one other one looking ahead to Trident. This is a bit of a different trial you're trying to extend for the indication where you already have approval. I don't want to put the cart before the horse here. But can you talk about maybe the regulatory and payer path that we should have in mind when we look ahead? If we make the assumption that this is a successful trial, is this a PMA supplement route you'd be pursuing? What kind of hoops do you think you'd have to jump through with payers? Anything like that would be helpful as we look ahead to early next year.

好的。很有幫助。謝謝，弗蘭克。然後還有另一個展望三叉戟。這是一個略有不同的試驗，您正嘗試將其延長至已獲得批准的適應症。我不想在這裡本末倒置。但是您能否談談我們在展望未來時應該考慮的監管和付款人路徑？如果我們假設這是一次成功的試驗，這是您會追求的 PMA 補充途徑嗎？您認為在與付款人打交道時需要經歷哪些困難？當我們展望明年年初時，任何類似的事情都會有所幫助。

Thanks for the question, Jason. This is Ashley. I'll just remind everybody that Trident is the trial in newly diagnosed GBM, which is studying the overall survival benefit of starting Tumor Treating Fields earlier and the treatment journey concurrent with radiation, rather than waiting for post chemoradiation, which is the current label.

謝謝你的提問，傑森。這是阿什利。我只是想提醒大家，Trident 是針對新診斷的膠質母細胞瘤 (GBM) 的試驗，該試驗正在研究早期開始腫瘤治療場和與放療同時進行的治療過程的總體生存益處，而不是等待放化療後，這是當前的標籤。

The trial reads out in the first half of next year. And we're excited to see, clearly, the data here because first of all, it provides a real benefit to extend survival even further. But also for physicians, the therapy earlier in the treatment journey with a real potential upside in duration.

該案將於明年上半年開庭審理。我們很高興清楚地看到這裡的數據，因為首先，它為進一步延長生存期提供了真正的好處。但對醫生來說，治療過程早期的治療具有延長治療時間的真正潛在優勢。

It's too soon to get specifics on actually what that will mean from a regulatory and a reimbursement perspective because it depends on the data. What I will say is that this will be easier than a Denovo PMA. It is an earlier start of our existing rela of of our existing label. and I would say that would extend to payer dynamics as well. The same coverage policies that apply newly diagnosed would need to incorporate this data. But I think it's an easier hurdle to cross than it is when you're starting with a new indication.

現在從監管和報銷角度了解這實際上意味著什麼還為時過早，因為這取決於數據。我想說的是，這比 Denovo PMA 更容易。這是我們現有標籤的現有關係的早期開始。我想說這也將擴展到付款人動態。適用於新診斷的相同覆蓋政策需要納入這些數據。但我認為，與剛開始嘗試新療法相比，跨越這個障礙要容易得多。

So too soon to get specifics because the data will drive those discussions, but we're very hopeful and excited about this trial.

現在還無法獲得具體細節，因為數據將推動這些討論，但我們對這次試驗充滿希望和興奮。

Okay. All right. We'll wait on that then. And then maybe if I could squeeze in one more just on the NCCN guidelines. I don't know if there's any way to handicap it, but just how do you think category 2a versus 2b versus 3 ultimately influences commercial coverage?

好的。好的。那我們就等著吧。然後也許我是否可以再擠進一個關於 NCCN 指南的內容。我不知道是否有任何方法可以限制它，但您認為 2a 類、2b 類和 3 類最終會如何影響商業覆蓋範圍？

Yeah. It's probably too soon to handicap, other than to say, anything is helpful. And the higher on the category ranking, you could go to the more helpful, right? So I think anything -- even being on the guidelines, any calculation is a step-up from where we are today. With additional publications, we'll continue to work our way up those guidelines, so I think that's important that it's not kind of where you start, it's where you end. Certainly, publication volume matters here. And we're as eager as everybody Is to see those updated guidelines published later this fall.

是的。現在做出預測可能還為時過早，但可以肯定的是，任何事情都是有幫助的。類別排名越高，您可以獲得的幫助就越多，對嗎？所以我認為任何事情——即使是按照指導方針，任何計算都比我們今天的情況有所進步。隨著更多出版物的出版，我們將繼續努力完善這些指導方針，所以我認為重要的是，這不是你的起點，而是你的終點。當然，出版量在這裡很重要。我們和大家一樣渴望看到今年秋天晚些時候發布的更新指南。

Perfect. Thank you.

完美的。謝謝。

Vijay Kumar, Evercore ISI.

維傑·庫馬爾（Vijay Kumar），Evercore ISI。

Hey, guys. Thanks for taking my question. Two from my side. One maybe on ASCO PANOVA (inaudible) actually, what was the reception at ASCO, if you could just elaborate on the physician feedback and compare -- contrast this with your prior presentations at ASCO.

嘿，大家好。感謝您回答我的問題。我這邊有兩個。一個可能是關於 ASCO PANOVA（聽不清楚）的，實際上，ASCO 的反響如何，您是否可以詳細說明醫生的反饋並進行比較 - 將其與您之前在 ASCO 的演講進行對比。

Maybe I'll start as the longest serving member of the team here. Vijay, our very first presentation at ASCO, which was the EF11 data, no one came to the presentation. EF-14, it was very well attended. But there was little understanding about the mechanism of action and just a lot of questions about what is this new therapy. This was by far the most exciting. ASCO that I've attended in 25 years.

也許我會成為這裡團隊中任職時間最長的成員。Vijay，我們在 ASCO 的第一次演講是關於 EF11 數據，但沒有人來聽演講。EF-14，出席人數非常多。但人們對於其作用機制的了解甚少，而且對於這種新療法是什麼仍有許多疑問。這是迄今為止最令人興奮的。我參加 ASCO 已經 25 年了。

We were front and center on the podium in the plenary session. We were included with all of the latest presentations. Our discussion, we mentioned this in the script, who was unfamiliar previously with Tumor Treating Fields therapy, a Dana-Farber physician concluded that our therapy should be standard of care. And ours was the only presentation for which that conclusion was delivered. The others were more study of this, more study of that, the side effects don't seem to justify the benefit.

我們站在全體會議講台的最前排中央。我們參與了所有最新的演示。我們在討論中，在劇本中提到了這一點，一位之前不熟悉腫瘤治療場療法的丹娜法伯醫生得出結論，我們的療法應該是標準治療方法。我們的演講是唯一得出這結論的演講。其他人對此進行了更多的研究，對那項進行了更多的研究，但副作用似乎並不能證明其益處。

And then we followed that with a discussion with our lead investigator who was a very effective presenter, and was a very effective advocate for the standard of care use of the therapy. And that was reflected in what I'll call, the talk on the floor. And maybe I'll turn it over to Frank and Ashley because we were all there, but to reflect on some of that, I'll call the, [hubbub], but this is highly anticipated, at this point.

然後，我們與我們的首席研究員進行了討論，他是一位非常有效的演講者，也是該療法的標準護理使用非常有效的倡導者。這反映在我所說的場內談話中。也許我會把它交給弗蘭克和阿什利，因為我們都在場，但為了反思其中的一些，我會稱之為 [喧囂]，但這是目前人們高度期待的。

The other thing I would add, Vijay, is that we were front page of the ASCO Daily News on Sunday, which was a lot of fun and new for us. And I would also say that that extended into the discussion. So ASCO is one event. It's great to see that energy and excitement. But we really needed that to continue on the ongoing physician dialogue and we've seen that, I was at ESMO GI in Barcelona last month when we were presenting the quality of life data. And I would say, it's a lot of fun to go to these courses when physicians are walking up to you, already aware of the data, excited about the data, and talking about next steps and where we can go from here.

維傑，我想補充的另一件事是，我們週日登上了《ASCO 每日新聞》的頭版，這對我們來說很有趣也很新鮮。我還想說，這延伸到了討論。ASCO 是一場盛會。看到這種活力和興奮真是太好了。但我們確實需要繼續進行正在進行的醫生對話，我們已經看到這一點，上個月我在巴塞隆納的 ESMO GI 上展示了生活品質數據。我想說，參加這些課程很有趣，當醫生走到你面前，已經了解數據，對數據感到興奮，並談論下一步以及我們可以從這裡走向哪裡。

That's helpful. Then maybe one for Christoph. On the revenues here, I think your 10-Q had some details on revenues recognized from performance obligations for prior period service rendered. I know, there is a CMS backlog payments one-off which comes in from time to time. What was the CMS back there? Is that included as part of this performance obligation? Or actually as we think about this CMS versus the non-CMS, is it more of a recurring feature or should we think of it as a one-off? Thank you.

這很有幫助。那麼也許一個是給克里斯托夫的。關於這裡的收入，我認為您的 10-Q 有一些關於從前期提供服務的履約義務中確認的收入的詳細資訊。我知道，CMS 積壓付款有時會一次發生。那裡的 CMS 是什麼？這是否包含在該履約義務中？或者實際上，當我們考慮這個 CMS 與非 CMS 時，它更像是一個重複性功能還是我們應該將其視為一次性功能？謝謝。

Yeah. I would think of it as a recurring feature. As I said also in the script, we recognize revenue by applying estimated future collection rates. And we do this by portfolio for commercial portfolio, for Medicare, for Medicaid. And we do this as best as we can. And so we would typically expect some revenue from prior periods as disclosed in the Q, in the range of somewhere between 3 to 5 percentage points. And that's in line with the Q2 of this year. Last year, there was a higher percentage and hence, we called it out.

是的。我認為它是一個重複的特徵。正如我在腳本中所說的那樣，我們透過應用預計的未來收款率來確認收入。我們透過商業組合、醫療保險和醫療補助組合來實現這一目標。我們會盡力做到最好。因此，我們通常會預期季度報告中揭露的前期收入將成長 3 到 5 個百分點。這與今年第二季的情況一致。去年，這個比例更高，因此我們公開了這一點。

Understood. And so just on CMS. Is CMS an active part of this, or is that separate?

明白了。僅就 CMS 而言。CMS 是其中活躍的一部分嗎，還是獨立的？

It's not really a key revenue driver of the prior period claims in this quarter.

這實際上並不是本季前期索賠的主要收入驅動因素。

Understood. Thank you, guys.

明白了。謝謝你們。

Jonathan Chang, Leerink Partners.

Jonathan Chang，Leerink Partners。

Hi guys. Thanks for taking my questions. First question, how should we be thinking about your path to profitability? How you tracking relative to your plans? And what are the key levers? And is there a time frame that we should be modeling around?

嗨，大家好。感謝您回答我的問題。第一個問題，我們該如何思考您的獲利之路？您如何追蹤您的計劃？關鍵的槓桿是什麼？是否存在一個我們應該圍繞其建模的時間框架？

And then second question on the pancreatic cancer opportunity. Are there plans to pursue combinations with other chemo regimens beyond what's being evaluated in PANOVA-3 and PANOVA-4? Thank you.

第二個問題是關於胰臟癌的機會。除了 PANOVA-3 和 PANOVA-4 所評估的方案之外，是否有計劃尋求與其他化療方案的結合？謝謝。

Hi, Jonathan. it's Christoph. So on our path to profitability, I would first say, look, it's very important for us to get to profitability. And as we alluded to in the past, we have a path to profitability. We are obviously very conscious of balancing investments in our launches as well as in future innovation, so basically R&D, with our intent to become profitable.

你好，喬納森，我是克里斯托夫。因此，在我們實現盈利的道路上，我首先要說的是，實現盈利對我們來說非常重要。正如我們過去提到的，我們有一條獲利之路。我們顯然非常清楚如何平衡對新產品和未來創新的投資，也就是基本上是研發的投資，以實現獲利。

In the past, we gave some color around the revenue level of around $750 million. We would expect to break into profitability from an adjusted EBITDA perspective. And I think that's still a good anchor to think about. And I think, we don't really want to give you a clear time frame. But I think with the revenue growth that you have seen in the past, that would probably give you some indications of when we think that's going to happen.

過去，我們曾對 7.5 億美元左右的收入水準做出一些估算。我們期望從調整後的 EBITDA 角度實現盈利。我認為這仍然是一個很好的值得思考的支柱。我認為，我們其實並不想給你一個明確的時間框架。但我認為，根據過去看到的收入成長情況，這可能會給你一些跡象，表明我們認為這種情況何時會發生。

I would say to your question of where are we relative to our expectations, we are in line with our expectations.

對於你提到的我們與預期之間的差距問題，我想說，我們與預期相符。

So to the second question, and thank you for that one, allow me first to contextualize that PANOVA-3 was the first positive trial with OS. And on top of that, the quality of life was positive as well as we saw it at ESMO. On the top of it, the pain-free survival was very positive. And that led to a huge discussion and interest by the investigators. And interestingly, when you combine the DPL to GNP standard of care, you don't have added adverse event, which means it's highly combination board, if I may say.

因此對於第二個問題，感謝您的提問，首先請允許我說明 PANOVA-3 是第一個具有 OS 的陽性試驗。最重要的是，生活品質也和我們在 ESMO 看到的那樣積極。最重要的是，無痛存活率非常高。這引起了研究人員的廣泛討論和興趣。有趣的是，當你將 DPL 與 GNP 護理標準結合時，你不會增加不良事件，這意味著它是高度組合的，如果我可以這麼說的話。

So we are actively discussing, actively looking into new combinations, and there are a few to come with a number of groups out there.

因此，我們正在積極討論、積極尋找新的組合，並且已經有一些組合即將出現。

And Jonathan, I'll just remind you that the next dataset we'll have public with pancreatic cancer is our PANOVA-4 data, which comes out in the front half of next year. Company sponsored looking at atezolizumab, (inaudible), nab-paclitaxel, and metastatic things. So we'll have that in hand and I think that will also inform future directions.

喬納森，我只想提醒你，我們將公開的下一個胰腺癌數據集是我們的 PANOVA-4 數據，將於明年上半年發布。本公司贊助研究阿替利珠單抗、（聽不清楚）、白蛋白結合型紫杉醇及轉移性疾病。所以我們會掌握這一點，我認為這也會為未來的方向提供參考。

Got it. Thanks for taking the questions.

知道了。感謝您回答這些問題。

Jessica Fye, J.P. Morgan.

費伊 (Jessica Fye)，摩根大通 (J.P. Morgan)。

Hey guys. Good morning. Thanks for taking my questions. Two questions for me sort of following up on some of the prior ones. First, can you just take us through why the METIS PMA in the back half of '25 could conceivably come after the PANOVA PMA in the third quarter of '25 given how much longer we've had the METIS data relative to PANOVA?

嘿，大家好。早安.感謝您回答我的問題。我有兩個問題，它們是對之前一些問題的延續。首先，您能否向我們解釋一下，考慮到我們擁有的 METIS 數據相對於 PANOVA 的時間更長，為什麼 25 年下半年的 METIS PMA 可能會晚於 25 年第三季度的 PANOVA PMA？

And the second one is just to clarify the comment on revenue from prior period claims. I think you said it was 3% to 5% of revenue. Do we apply that to the $94 million of US Optune Gio sales this quarter, so like 2.8% to 4.7%? Or should I apply that 3% to 5% range to some other revenue number? Thank you.

第二點只是為了澄清關於前期索賠收入的評論。我認為您說的是收入的 3% 到 5%。我們是否將其應用於本季美國 Optune Gio 的 9,400 萬美元銷售額，即 2.8% 至 4.7%？或者我應該將 3% 到 5% 的範圍應用到其他收入數字？謝謝。

Jessica, this is Ashley. I'll try to answer both of those. And then if you have a follow-up, I'll hand it off to Christoph. But the first is an easy answer. It's actually the form factor of the submission, so I'll remind you that with METIS, we have a modular submission, so Modules 1 and 2, went in in April this year to the FDA. This was an important pathway because it's actually the first time this device is under review at the FDA. It's our torso application, but at 150 kilohertz, which is our lung cancer frequency. So those two modules need to get through at the FDA through (inaudible) to approval before we're able to submit Module 3.

傑西卡，這是阿什莉。我會盡力回答這兩個問題。如果您有後續問題，我會將其交給 Christoph。但第一個問題的答案很簡單。這實際上是提交的形式因素，所以我要提醒您，使用 METIS，我們有一個模組化提交，因此模組 1 和 2 於今年 4 月提交給了 FDA。這是一個重要的途徑，因為這實際上是該設備首次接受 FDA 的審查。這是我們的軀幹應用，但頻率為 150 千赫，這是我們的肺癌頻率。因此，這兩個模組需要通過 FDA（聽不清楚）批准，然後我們才能提交模組 3。

So that's simply the gating reason. We're in productive discussions in fact later this quarter we will have our pre-submission meeting with the FDA that's scheduled for clinical module. But the pacing of it will actually be dependent on Modules 1 and 2 getting through the review process. And then that final module will just be the clinical module. So it's a very straight-forward and easy answer.

這就是簡單的門控原因。事實上，我們正在進行富有成效的討論，本季稍後我們將與 FDA 舉行針對臨床模組的提交前會議。但其進度實際上取決於模組 1 和 2 是否通過審核過程。那麼最後一個模組就是臨床模組。所以這是一個非常直接和簡單的答案。

To the second, I would just remind everybody that this is not new, so this is disclosure. You can actually go and look at it with the prior kind of years. And we've always seen it in line of this 3% to 5%, And anytime it bubbled up above that, we call it out on the script. So I would say I wouldn't try to model this anymore. This is well baked and in our (inaudible) has been since the implementation of (inaudible). Thank you.

對於第二點，我只想提醒大家，這並不是什麼新鮮事，所以這是公開的。您實際上可以結合前幾年的情況來看看。我們一直看到它處於 3% 到 5% 之間，每當它超過這個水平時，我們就會在腳本中發出警報。所以我想說我不會再嘗試建模了。這是很好的，並且在我們的（聽不清楚）自從實施以來（聽不清楚）。謝謝。

(inaudible) Kevin Dee Jeter, Ladenburg Thalmann.

（聽不清楚）凱文·迪·傑特、拉登堡·塔爾曼。

Hey. Great. Thanks for taking my questions this morning. I want to follow up on on Optune Lua, specifically the positioning as more of a post platinum progression versus second line, specifically for the NCCN guidelines. Is there anything you're looking for potentially in the language there to help you support your positioning in the market and discussions with payers? And I guess on related point, if you had any feedback from payers as to whether they see the distinction as material when they consider potential coverage decisions.

嘿。偉大的。感謝您今天上午回答我的問題。我想跟進 Optune Lua，特別是將其定位為鉑金後進展而不是二線治療，特別是針對 NCCN 指南。您是否希望那裡的語言能夠幫助您支援市場定位以及與付款人的討論？我想就相關問題而言，如果您收到付款人的任何回饋，請詢問他們在考慮潛在的核保決定時是否認為這種差異很重要。

I'll start at the end with the payer note, I will say, I think we've seen some initial progress with payers that -- you know what, I'd really attribute it again to the point that this is an area of high clinical unmet need and the doctors see it and the payer see it.

我將從付款人說明開始，我想說，我認為我們已經看到付款人取得了一些初步進展 - 你知道嗎，我真的會再次將其歸因於這是一個臨床未滿足需求很高的領域，醫生看到了這一點，付款人也看到了這一點。

Looking, in terms of positioning and the length of the positioning to NCCN, we don't necessarily see a key link there. We have to fit into the guidelines as the NCCN has already published them. So we're not trying to influence the way in which they present their guidelines. That said, what we are doing and you'll begin to see soon is that we're publishing real-world evidence around the patient population that we have, treating ercially. And really using that to shape physician perception of where to use the device and ultimately over time to then push that deeper and deeper into the community, this idea of once you're post platinum and you're thinking about what do I do at the first sign the patient's not doing well. Good option.

從定位以及與 NCCN 的定位長度來看，我們不一定能看到其中的關鍵連結。我們必須遵守 NCCN 已經發布的指南。因此我們不會試圖影響他們提出指導方針的方式。話雖如此，我們正在做的事情，你很快就會看到，我們正在發布圍繞我們商業治療的患者群體的真實世界證據。並真正利用它來塑造醫生對在哪裡使用該設備的看法，並最終隨著時間的推移將其越來越深入地推廣到社區，這個想法是，一旦你達到白金級別，你就會在思考當病人出現不適的第一個跡象時我該怎麼做。不錯的選擇。

Great. And then just as a follow-up, in your prior calls, you discussed the potential opportunity for US commercial decisions on Optune Lua potentially in 2025 based on the, I guess, potential timing of NCCN guideline. Is that still the right way to think about the pace of dialogue with major US players or you're perhaps into 2026 and more realistic assessment?

偉大的。然後作為後續，在您之前的電話會議中，您討論了美國可能在 2025 年就 Optune Lua 做出商業決策的潛在機會，我猜這是基於 NCCN 指南的潛在時間。這仍然是思考與美國主要參與者對話步伐的正確方式嗎？或者您可能對 2026 年有了更現實的評估？

Kevin, I mean, listen, it's not a binary switch, first of all, these ramp up over time and what you've seen is that we're seeing early successes, so we had $1.1 million in this quarter and I think we would expect each quarter to add a few sizable number to that target to get to where we would exit '25 with not immaterial, but not a significant amount of money from Optune Lua in the US. We think we're on track for that, and we would expect really the full driver of top line growth appearing in 2026. So exiting with strength in '25 and releasing material top line growth in 2026.

凱文，我的意思是，聽著，這不是一個二進制開關，首先，這些會隨著時間的推移而增加，而且你已經看到，我們看到了早期的成功，所以我們在本季度有 110 萬美元，我認為我們預計每個季度都會在這個目標上增加一些可觀的數字，以達到我們在 25 年退出時從美國的 Optunea 獲得很多的資金，但不是很多。我們認為我們正朝著這個目標前進，並且我們預計收入成長的全面動力將在 2026 年真正顯現。因此，我們將在 2025 年以強勁勢頭退出，並在 2026 年實現實質營收成長。

Thanks for taking the questions.

感謝您回答這些問題。

Emily Bodnar, H.C. Wainwright.

艾米麗·博德納、H.C. 溫賴特。

Hi. Good for taking our questions. Could you clarify if the $94 million in US sales includes the $2.4 million from Optune Lua or was that separate? And then in terms of revenues from Germany, would you expect any kind of one-off reimbursement, cases similar to what you're now seeing in the US in the second half of 2025.

你好。很高興回答我們的問題。您能否澄清一下，美國 9,400 萬美元的銷售額是否包括 Optune Lua 的 240 萬美元，還是單獨包含的？那麼就德國的收入而言，您是否預計會出現任何形式的一次性報銷，類似於您現在在 2025 年下半年在美國看到的情況。

Emily, the $94 million includes all of the revenue inclusive of the Optune Lua. So that's both Optune Gio and Optune Lua. And yes, I mean, the US and Germany are the two markets that we have the opportunity to go and seek case by case reimbursement so it'll follow a similar trajectory in Germany as we're seeing (inaudible) in the US.

艾米麗，9,400 萬美元包括 Optune Lua 在內的所有收入。這就是 Optune Gio 和 Optune Lua。是的，我的意思是，美國和德國是我們有機會去尋求逐案報銷的兩個市場，因此它在德國將遵循與我們在美國看到的（聽不清楚）類似的軌跡。

Got it. Okay. Makes sense. And then I know it's probably still pretty early, but are you able to comment at all about efficacy you're seeing in real-world cases for lung cancer and how that's kind of related to the LUNAR trial, particularly in the patients who've had prior immune checkpoint inhibitors?

知道了。好的。有道理。然後我知道現在可能還為時過早，但您能否評論一下您在現實世界的肺癌病例中看到的療效，以及這與 LUNAR 試驗有何關聯，特別是對於之前接受過免疫檢查點抑製劑治療的患者？

Hi. This is Frank, and thank you for the question. I would say, we're not able to track to overall survival so we can't comment on a hard clinical endpoint. But what we do see is that usage of the device is consistent with what we saw in the trial, which is our best proxy to say these patients are using it the same way. And as I said, we're seeing physicians who have now had patients on from the launch quarter, so we're pretty far into it. And they're expressing a strong confidence in building a practice with more and more patients on the therapy.

你好。我是弗蘭克，謝謝你的提問。我想說，我們無法追蹤整體存活率，所以我們無法對硬性臨床終點發表評論。但我們確實看到的是，該設備的使用情況與我們在試驗中看到的一致，這是我們最好的證明，表明這些患者以相同的方式使用它。正如我所說，我們看到醫生從產品發布季度開始就已經開始接待患者，因此我們已經取得了很大進展。他們表示，他們有信心建立一個能讓越來越多的患者接受治療的診所。

Okay. Great. Thank you.

好的。偉大的。謝謝。

There are no further questions one the queue. I will now turn the call back over to Mr. Bill Doyle for any closing remarks.

隊列中沒有其他問題。現在我將把電話轉回給比爾·道爾先生，請他做最後發言。

Thank you. As we've unlined during the last few quarterly calls, this is a very exciting time at Novocure. We are moving from a single indication company, treating patients with GBM, to a multi-indication international cancer therapy company. We've made tremendous progress this year so far. All first on the foundation of a very strong and stable business in GBM. And one where, as Ashley and Christoph noted, we now have hit the 11th successive quarter of active patient growth. And from there, We're in the early days, but exciting days of our Optune Lua launch in non-small cell. And we are furiously busy at the FDA with both our METIS and our PARNOVA-3 filings, With the potential for launches next year in pancreatic cancer and in brain mets from non-small cell lung cancer.

謝謝。正如我們在過去幾次季度電話會議中所言，這是 Novocure 非常激動人心的時刻。我們正在從一家治療膠質母細胞瘤 (GBM) 患者的單一適應症公司轉型為治療多種適應症的國際癌症治療公司。今年到目前為止我們已經取得了巨大的進步。一切首先建立在 GBM 非常強大和穩定的業務基礎上。正如阿什利和克里斯托夫所指出的，我們現在已經連續第 11 個季度實現活躍患者成長。從那時起，我們就處於 Optune Lua 在非小型蜂窩中推出的早期階段，但這是一個令人興奮的日子。我們正忙於向 FDA 提交 METIS 和 PARNOVA-3 的申請，這些藥物有可能在明年上市，用於治療胰腺癌和非小細胞肺癌腦轉移。

We're busy. It's exciting. And we look forward to keeping you up-to-date in future calls.

我們很忙。這很令人興奮。我們期待在未來的通話中向您通報最新情況。

Ladies and gentleman, this concludes the conference for today. Thank you for your participation. You may now disconnect.

女士們、先生們，今天的會議到此結束。感謝您的參與。您現在可以斷開連線。