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Operator
Operator
Good day, and thank you for standing by. Welcome to the Novocure fourth-quarter 2024 earnings conference call. (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 2024 年第四季財報電話會議。(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 speaker today, Ingrid Goldberg. Please go ahead.
現在我想將會議交給今天的演講者英格麗德·戈德堡 (Ingrid Goldberg)。請繼續。
Ingrid Goldberg - Vice President, Finance and Investor Relations
Ingrid Goldberg - Vice President, Finance and Investor Relations
Good morning. and thank you for joining us to review Novocure's fourth quarter and full year 2024 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 executive leadership team will be available for Q&A.
早安.感謝您與我們一起回顧 Novocure 2024 年第四季和全年的業績。今天早上我與我們的執行主席比爾·道爾通了電話;首席執行官 Ashley Cordova;以及我們的首席財務官 Christoph Brackmann。我們的執行領導團隊的其他成員將參與問答。
For your reference, slides accompanying this earnings release can be found on our website, www.novocure.com, on the Investor Relations page under quarterly reports.
供您參考,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 noncash 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, earnings slides and in our Form 10-K filed with the SEC today. These materials can also be accessed from the Investor Relations page of our website.
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,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-K 表中。您也可以從我們網站的投資者關係頁面存取這些資料。
Following our prepared remarks today, we will open the line for your questions. I will now turn the call over to our Executive Chairman, Bill Doyle.
在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。現在我將把電話轉給我們的執行主席比爾·道爾 (Bill Doyle)。
William Doyle - Executive Chairman of the Board
William Doyle - Executive Chairman of the Board
Thank you, Ingrid, and good morning, everyone. For 25 years, our mission at Novocure has been to extend survival for patients with some of the most aggressive forms of cancer by developing and commercializing our novel therapy tumor-treating fields. Prior to 2025, our commercial efforts focused largely on the treatment of glioblastoma. After achieving key milestones in 2024, FDA approval for the treatment of non-small cell lung cancer and successful Phase 3 readouts in pancreatic cancer and brain mets from non-small cell lung cancer, 2025 is set to be a defining year for Novocure as we move beyond a single indication to become a multi-indication oncology company.
謝謝你,英格麗德,大家早安。25 年來,Novocure 的使命一直是透過開發和商業化我們的新型腫瘤治療領域來延長某些最具侵襲性的癌症患者的生存期。2025 年之前,我們的商業努力主要集中在膠質母細胞瘤的治療。在 2024 年實現關鍵里程碑之後,FDA 批准其用於治療非小細胞肺癌,並成功完成胰腺癌和非小細胞肺癌腦轉移的 3 期讀數,2025 年將成為 Novocure 的決定性一年,因為我們將超越單一適應症,成為一家多適應症腫瘤學公司。
Our focus now is on execution and bringing TTFields therapy to many more patients in need. Entering 2024, we define three clear objectives for our organization: grow our core GBM business, launch our non-small cell lung cancer indication and deliver on the promise of our clinical pipeline. I am proud to report we achieved all of these objectives.
我們現在的重點是執行並將 TTFields 療法帶給更多有需要的患者。進入 2024 年,我們為組織定義了三個明確的目標:發展我們的核心 GBM 業務、推出我們的非小細胞肺癌適應症並兌現我們的臨床管線承諾。我很自豪地報告我們實現了所有這些目標。
In 2024, we generated $605 million in net revenue, growing our global active patient count to over 4,000. We received FDA PMA approval to treat second-line non-small cell lung cancer with a broad label and immediately began treating patients in the US. And we had two additional positive readouts from large, randomized Phase 3 clinical trials: METIS in brain mets from non-small cell lung cancer and PANOVA-3 in locally advanced pancreatic cancer.
2024 年,我們的淨收入達到 6.05 億美元,全球活躍患者數量成長至 4,000 多人。我們獲得了 FDA PMA 批准,以廣泛的標籤治療二線非小細胞肺癌,並立即開始在美國治療患者。我們從大型隨機 3 期臨床試驗中獲得了另外兩個積極的讀數:非小細胞肺癌腦轉移的 METIS 和局部晚期胰腺癌的 PANOVA-3。
2024 was a year of strong achievement at Novocure and has set the stage for a pivotal year in 2025. In the 25 years since our founding, we have grown to a team of nearly 1,500 people, treated over 35,000 GBM patients and are now poised to reach tens of thousands more with other difficult-to-treat cancers in the years to come. Our organizational evolution has included preparing to scale our operations to effectively reach these patients while continuing to expand our approved indications.
2024 年是 Novocure 取得巨大成就的一年,並為 2025 年的關鍵一年奠定了基礎。自成立以來的 25 年裡,我們已發展成為一個擁有近 1,500 人的團隊,治療了超過 35,000 名 GBM 患者,並且準備在未來幾年內為數萬名患有其他難治性癌症的患者提供治療。我們的組織變革包括準備擴大我們的業務規模以有效地接觸這些患者,同時繼續擴大我們批准的適應症。
Last year, we announced that Ashley Cordova, our CFO, would succeed our founding CEO, Asaf Danziger, after his retirement in December; and the Christoph Brackmann will be joining our team as our new CFO. 2025 marks the beginning of a new chapter for Novocure as we build upon our strong foundation treating patients with GBM to begin to realize the full potential of the Tumor Treating Fields platform.
去年,我們宣布財務長 Ashley Cordova 將在創始執行長 Asaf Danziger 12 月退休後接任其職位; Christoph Brackmann 將加入我們的團隊並擔任新任財務長。 2025 年標誌著 Novocure 新篇章的開始,我們將在治療膠質母細胞瘤 (GBM) 患者的堅實基礎上,開始充分發揮腫瘤治療場平台的潛力。
I am pleased to turn the call to Ashley to provide more detail on our achievements in 2024 and our plans for 2025. Christoph will then review our fourth quarter and full year financial performance, after which we will take your questions. Ashley?
我很高興請阿什利詳細介紹我們在 2024 年取得的成就以及 2025 年的計劃。克里斯托夫隨後將回顧我們第四季和全年的財務業績,之後我們將回答您的問題。阿什利?
Ashley Cordova - Chief Executive Officer
Ashley Cordova - Chief Executive Officer
Thank you, Bill. I am honored to step into the role of Chief Executive Officer at this pivotal moment in Novocure's history. Our mission has never felt more urgent as we expand our reach to patients facing some of the most challenging followed tumors with significant unmet need.
謝謝你,比爾。我很榮幸能夠在 Novocure 歷史的這個關鍵時刻擔任執行長一職。隨著我們擴大服務範圍,接觸到面臨一些最具挑戰性的腫瘤且存在大量未滿足治療需求的患者,我們的使命變得前所未有的緊迫。
To provide more detail on Bill's opening remarks, our first objective in 2024 was to grow our GBM business. GBM remains the foundation of our company, providing financial strength to invest in our pipeline and execute multiple launches.
為了更詳細地介紹比爾的開場白,我們 2024 年的首要目標是發展我們的 GBM 業務。GBM 仍然是我們公司的基礎,為投資我們的產品線和執行多項發布提供了財務實力。
In 2024, we grew active patients by 10%, surpassing 4,000 active patients on therapy for the first time. Our growth was driven by strong performance in multiple markets, including France, now our third-largest market, and Germany and Japan. Improved US approval rates contributed to 2024 top line growth as higher US net pricing complemented the increase in global active patients.
2024 年,我們的活躍患者數量將增加 10%,接受治療的活躍患者數量首次超過 4,000 名。我們的成長得益於多個市場的強勁表現,包括法國(目前我們的第三大市場)、德國和日本。由於美國淨價格上漲補充了全球活躍患者的增加,美國批准率的提高促進了 2024 年營收的成長。
Our second goal in 2024 was to launch our newest indication, Optune Lua, in second-line non-call lung cancer. Entering the year, we submitted a PMA application to the FDA based on the LUNAR Phase 3 clinical trial data and began the process of building a thoracic sales force in anticipation of FDA approval.
我們在 2024 年的第二個目標是推出我們的最新適應症 Optune Lua,用於治療二線非轉移性肺癌。進入新年,我們根據LUNAR三期臨床試驗數據向FDA提交了PMA申請,並開始組建胸腔銷售隊伍,以期獲得FDA的批准。
On October 15, we received FDA approval with a broad label, including both toplitaxel and physician's choice of immune checkpoint inhibitor as concomitant therapy option. Our Optune Lua sales team was immediately in the field. And between approval and year-end, we received 52 prescriptions, and we finished the year with 20 active patients on therapy.
10 月 15 日,我們獲得了 FDA 的批准,其範圍廣泛,包括托普他賽和醫生選擇的免疫檢查點抑制劑作為伴隨治療選擇。我們的 Optune Lua 銷售團隊立即趕赴現場。從批准到年底,我們收到了 52 張處方,年底共有 20 名活躍患者接受治療。
We are pleased with these initial results and the early feedback from patients and physicians is promising. Patients are eager to access a new unique therapy in non-small cell lung cancer. And we are seeing interest from thoracic oncologists, medical oncologists and radiation oncologists in both concomitant chemotherapy and immunotherapy option.
我們對這些初步結果感到滿意,患者和醫生的早期回饋也令人鼓舞。患者渴望獲得一種治療非小細胞肺癌的新型獨特療法。我們看到胸腔腫瘤科醫師、腫瘤內科醫師和放射腫瘤科醫師對合併化療和免疫治療方案很感興趣。
While early demand is promising, we remind investors that we are currently in the process of securing reimbursement, and these negotiations take time. We expect payer coverage milestones in 2025 with material revenue ramping in 2026 as coverage expands.
雖然早期需求看好,但我們提醒投資人,目前正處於確保償還的過程中,這些談判需要時間。我們預計,隨著覆蓋範圍的擴大,付款人覆蓋範圍將在 2025 年達到里程碑,而材料收入將在 2026 年大幅增加。
Our final 2024 objective was to deliver on the promise of our clinical pipeline in indications with extremely high unmet need. In March, we announced successful top line results from our Phase 3 METIS trial investigating Tumor Treating Fields therapy for the treatment of brain metastases from non-cell lung cancer following stereotactic radiosurgery.
我們 2024 年的最終目標是兌現針對極高未滿足需求的適應症的臨床管線承諾。今年 3 月,我們宣布了 3 期 METIS 試驗的成功頂線結果,該試驗研究了腫瘤治療場療法在立體定位放射外科治療非細胞肺癌腦轉移中的應用。
METIS met its primary end point. Patients treated with Tumor Treating Fields therapy exhibited 21.9 months median time to intracranial progression compared to 11.3 months for patients treated with supportive care. In December, we announced successful top line results from our Phase 3 PANOVA-3 trial, investigating tumor treating field therapy together with gemcitabine and nab paclitaxel for the treatment of unresectable locally advanced pancreatic cancer.
METIS 達到了主要終點。接受腫瘤治療場療法的患者顱內進展的中位數時間為 21.9 個月,而接受支持治療的患者顱內進展的中位數時間為 11.3 個月。12 月,我們宣布了 3 期 PANOVA-3 試驗的成功頂線結果,該試驗研究了腫瘤治療場療法聯合吉西他濱和白蛋白紫杉醇治療無法切除的局部晚期胰腺癌。
PANOVA-3 also met its primary end point as patients randomized to receive Tumor Treating Fields therapy demonstrated a median overall survival of 16.2 months compared to 14.2 months in the control arm. PANOVA-3 is the first and only Phase 3 trial to demonstrate a statistically significant survival benefit in this notoriously difficult-to-treat patient population.
PANOVA-3 也達到了主要終點,隨機接受腫瘤治療場療法的患者的中位總生存期為 16.2 個月,而對照組為 14.2 個月。PANOVA-3 是第一個也是唯一一個證明這種療法對這一眾所周知的難治性患者群體具有統計上顯著的生存益處的 3 期試驗。
Early reactions from key pancreatic physicians have been very supportive, and we look forward to presenting the full data set at a medical conference later this year. METIS and PANOVA-3 represent major opportunities to expand our market reach as each serves patient populations with extremely high unmet need. Brain metastases from non-small cell lung cancer and locally advanced pancreatic cancer, together with our recent lung cancer launch, have the potential to increase our eligible patient population to 7 times our GBM opportunity.
主要胰臟科醫生的早期反應非常支持,我們期待在今年稍後的醫學會議上展示完整的數據集。METIS 和 PANOVA-3 代表我們擴大市場覆蓋範圍的重大機遇,因為它們都服務於具有極高未滿足需求的患者群體。非小細胞肺癌和局部晚期胰腺癌的腦轉移,加上我們最近推出的肺癌治療,有可能將我們的合格患者數量增加到 GBM 機會的 7 倍。
Beyond these near-term catalysts, we continue to invest in our pipeline in GBM, lung and pancreatic cancers. With ongoing trials like TRIDENT, LUNAR-2, KEYNOTE-D58 and PANOVA-4, we see additional label expansion potential over the next few years. To touch on these trials quickly, our Phase 3 TRIDENT trial in GBM is studying the addition of tumor treating field therapy to chemoradiation rather than starting after chemoradiation, potentially increasing the duration and efficacy benefit of Tumor Treating Fields.
除了這些近期催化劑之外,我們還將繼續投資於膠質母細胞瘤、肺癌和胰腺癌領域的研發管線。隨著 TRIDENT、LUNAR-2、KEYNOTE-D58 和 PANOVA-4 等試驗的進行,我們看到未來幾年標籤將有更大的擴展潛力。為了快速介紹這些試驗,我們在膠質母細胞瘤 (GBM) 中的 3 期 TRIDENT 試驗正在研究將腫瘤治療場療法添加到放化療中,而不是在放化療後開始,這可能會增加腫瘤治療場療法的持續時間和療效。
TRIDENT is fully enrolled, and we expect data in the first half of 2026. Our other pipeline trials are studying the concomitant use of tumor treating field therapy and immune checkpoint inhibitors, a regimen that showed a missed promise in the LUNAR data set. These trials include our Phase 3 LUNAR-2, our Phase 2 LUNAR-4, our Phase 3 KEYNOTE-D58 and our Phase 2 PANOVA-4 trial.
TRIDENT 已完全招募,我們預計將於 2026 年上半年獲得數據。我們的其他管道試驗正在研究腫瘤治療場療法和免疫檢查點抑制劑的聯合使用,該方案在 LUNAR 數據集中顯示了未能實現的希望。這些試驗包括我們的第 3 階段 LUNAR-2 試驗、第 2 階段 LUNAR-4 試驗、第 3 階段 KEYNOTE-D58 試驗和第 2 階段 PANOVA-4 試驗。
The first three trials are open and enrolling. PANOVA-4 is fully enrolled, and we expect data in the first half of 2026. These trials represent the next wave of innovation in Novocure's clinical pipeline with the potential to significantly expand the use of Tumor Treating Fields therapy and the cancers where we have already established clinical benefit.
前三項試驗現已開放並開始招生。PANOVA-4 已完全招募,我們預計將於 2026 年上半年獲得數據。這些試驗代表了 Novocure 臨床管線的下一波創新,有可能顯著擴大腫瘤治療場療法的應用範圍以及我們已經確定臨床益處的癌症。
Beyond the progress made advancing our clinical pipeline, we achieved key milestones in our product development program with the approval of our HFE arrays in the US and Japan. The HFE arrays are thinner, lighter and more flexible than our legacy arrays. We are rolling out the HFE arrays in all major markets, and feedback has been very encouraging. We believe the rollout of our next-generation HFE array is an important step in improving patients' usage, reducing barriers to adoption and ultimately expanding the market for tumor treating field therapy.
除了在臨床開發方面取得進展之外,我們的 HFE 陣列在美國和日本獲得批准,在產品開發計劃中也取得了重要里程碑。HFE 陣列比我們的傳統陣列更薄、更輕、更靈活。我們正在所有主要市場推出 HFE 陣列,反饋非常令人鼓舞。我們相信,推出下一代 HFE 陣列是改善患者使用、減少採用障礙並最終擴大腫瘤治療場治療市場的重要一步。
As we reflect on the progress achieved in 2024, the Novocure story has substantially evolved. With the binary clinical events of prior years behind us, we are now focused on execution. 2025 is off to a strong start, and we expect to reach multiple important milestones this year.
當我們回顧 2024 年的進展時,Novocure 的故事已經有了實質的發展。隨著前幾年二元臨床事件的發生,我們現在專注於執行。 2025 年開局強勁,我們預計今年將實現多個重要里程碑。
In lung cancer, we will continue to provide insights into the progress of our Optune Lua launch. We will pursue clinical guidelines and reimbursement in the US and regulatory approvals in Europe and Japan. In brain mets, we expect to publish the METIS trial results and are engaged with the FDA in pre-submission discussions in anticipation of submitting a PMA application later this year.
在肺癌領域,我們將繼續提供有關 Optune Lua 發布進展的見解。我們將尋求美國的臨床指南和報銷以及歐洲和日本的監管批准。在腦轉移瘤方面,我們預計將發布 METIS 試驗結果,並與 FDA 進行提交前的討論,以期在今年稍後提交 PMA 申請。
In pancreatic cancer, we expect to present the PANOVA data at an upcoming medical conference, followed by publication in a peer-reviewed journal. And again, we are engaged with the FDA and pre-submission discussion in anticipation of submitting a PMA application later this year.
在胰臟癌方面,我們預計將在即將舉行的醫學會議上展示 PANOVA 數據,然後在同行評審期刊上發表。再次,我們正在與 FDA 進行提交前的討論,以期在今年稍後提交 PMA 申請。
With FDA breakthrough designation for both brain mets and pancreatic cancer, we have the potential for launches in both indications in 2026. 2025 marks the beginning of a new era in Novocure's journey as we evolve from one indication in GBM to a multi-indication platform therapy company. The vision is clear. We are working to extend survival for as many patients as possible as we build on an incredibly strong foundation.
憑藉 FDA 對腦轉移瘤和胰腺癌的突破性治療指定,我們有可能在 2026 年推出這兩種適應症的產品。 2025 年標誌著 Novocure 旅程新時代的開始,我們將從膠質母細胞瘤 (GBM) 的單一適應症發展成為多適應症平台治療公司。願景清晰。我們正在建立一個極其堅實的基礎,努力延長盡可能多的患者的生存期。
With that, I would like to turn the call over to our newest executive colleague, Christoph Brackmann.
說到這裡,我想把電話轉給我們最新的執行同事 Christoph Brackmann。
Christoph Brackmann - Chief Financial Officer
Christoph Brackmann - Chief Financial Officer
Thank you, Ashley, and thank you all for joining us this morning. This is an incredibly exciting time for Novocure as we pivot from a single indication to a multi-indication company, and I feel very privileged to be joining Novocure at this unique time.
謝謝你,阿什利,也謝謝大家今天早上加入我們。對於 Novocure 來說,這是一個令人難以置信的激動人心的時刻,因為我們從單一適應症公司轉向多適應症公司,我很榮幸能夠在這個獨特的時刻加入 Novocure。
2024 was a year of successful execution and growth. We generated revenues of $161 million in the fourth quarter of 2024, an increase of 21% compared to the same period in 2023 and $605 million for the full year, an increase of 19% year-over-year. This growth was primarily driven by our continued launch success in France, strong active patient growth in Germany and Japan, and significantly improved approval rates in the US, which are now reflected in our revenue baseline.
2024年是成功執行和成長的一年。我們在 2024 年第四季創造了 1.61 億美元的收入,比 2023 年同期成長 21%,全年創造了 6.05 億美元的收入,年增 19%。這一成長主要得益於我們在法國的持續成功上市、德國和日本的活躍患者強勁增長以及美國批准率的顯著提高,這些都反映在我們的收入基準中。
Improved approval rates in the US resulted in $8.3 million of revenue from prior period claims during the quarter and $22.3 million for the full year. 2025 revenue growth is expected to closely reflect growth in Optune Gio active patients. As the GBM business reaches maturity, we expect to continue to grow at a low mid-single-digit rate this year.
美國批准率的提高導致本季來自前期索賠的收入為 830 萬美元,全年收入為 2,230 萬美元。預計 2025 年營收成長將密切反映 Optune Gio 活躍患者的成長。隨著 GBM 業務日趨成熟,我們預計今年將繼續以中個位數的低速成長。
On the lung side, as Ashley explained earlier, our focus this year is on educating physicians, generating demand and negotiating payer coverage. We anticipate meaningful revenue contribution starting in 2026 as coverage expands.
在肺部方面,正如阿什利之前解釋的那樣,我們今年的重點是教育醫生、創造需求和協商付款人承保。隨著覆蓋範圍的擴大,我們預計從 2026 年開始將帶來可觀的收入貢獻。
Looking further ahead, we believe we have a clear path to address the patient population in multiple indications, which, taken together, is 7 times larger than our GBM opportunity, and we are very focused on execution to reach these patients.
展望未來,我們相信我們有一條清晰的途徑來解決多種適應症的患者群體,這些群體加起來比我們的 GBM 機會大 7 倍,而且我們非常專注於執行以接觸這些患者。
Our gross margin in the fourth quarter was 79% and 77% for the full year 2024 compared to 75% in 2023. The improvement in gross margin is due to the increase in net revenue per patient, primarily attributed to our improved approval rates in the US.
我們第四季的毛利率為 79%,2024 年全年的毛利率為 77%,而 2023 年為 75%。毛利率的提高是由於每位患者的淨收入增加,這主要歸功於我們在美國的批准率提高。
This year, we expect the global launch of the HFE arrays in the non-small cell lung cancer launch to be headwinds to gross margin. Regarding the ongoing global trade discussions, our global manufacturing supply chain networks allow for flexibility and capacity optimization. Based on current estimates, we do not foresee a material impact to margins in the short term, but we will continue to monitor this fluid situation closely.
今年,我們預計 HFE 陣列在非小細胞肺癌領域的全球發布將對毛利率產生不利影響。關於正在進行的全球貿易討論,我們的全球製造供應鏈網路具有靈活性和產能優化能力。根據目前的估計,我們預計短期內不會對利潤率產生重大影響,但我們將繼續密切關注這種不穩定的情況。
Sales and marketing expenses in the fourth quarter were $67 million and $239 million for the full year, reflecting increases of 14% and 5%, respectively, compared to prior year periods. G&A expenses in the fourth quarter were $72 million and $190 million for the full year, reflecting increases of 84% and 16%, respectively, primarily driven by stock-based compensation expenses related to the lung approval. Excluding stock-based compensation, G&A expenses for the full year were $10 million lower than 2023, driven by our 2023 restructuring efforts.
第四季銷售和行銷費用為 6,700 萬美元,全年銷售和行銷費用為 2.39 億美元,分別比去年同期成長 14% 和 5%。第四季的一般及行政費用為 7,200 萬美元,全年為 1.9 億美元,分別增長 84% 和 16%,主要由於與肺癌批准相關的股票薪酬費用。不包括股票薪酬,由於我們 2023 年的重組努力,全年的 G&A 費用比 2023 年低 1000 萬美元。
Looking ahead, as our thoracic sales forces in the US and Germany are now fully staffed, we would expect some incremental expense primarily for marketing and in preparation for launch in additional countries. Research and development costs for the fourth quarter were $51 million, bringing the annual total to $210 million, decreases of 6% from both prior periods. We anticipate our R&D expenses to be roughly stable in 2025.
展望未來,由於我們在美國和德國的胸腔銷售隊伍現已滿員,我們預計會有一些增量支出,主要用於行銷和準備在其他國家推出產品。第四季研發成本為 5,100 萬美元,全年總額達 2.1 億美元,較前兩季下降 6%。我們預計 2025 年我們的研發費用將大致保持穩定。
Net loss for the fourth quarter was $66 million or $0.61 per share. Net loss for the year was $169 million or $1.56 per share. Adjusted EBITDA for the fourth quarter was $3 million, an increase of $34 million from Q4 2023; and full year adjusted EBITDA was $1 million, an increase of $107 million compared to last year. This increase in adjusted EBITDA was driven by growth in net revenue as well as disciplined management of operating expenses.
第四季淨虧損為 6,600 萬美元,即每股 0.61 美元。全年淨虧損為 1.69 億美元,即每股 1.56 美元。第四季調整後 EBITDA 為 300 萬美元,較 2023 年第四季增加 3,400 萬美元;全年調整後EBITDA為100萬美元,較去年同期增加1.07億美元。調整後 EBITDA 的成長得益於淨收入的成長以及嚴格的營運費用管理。
While we continue to invest in growth opportunities, profitability remains an important goal at Novocure and something we are actively driving towards. We anticipate generating positive adjusted EBITDA on a sustainable basis once we generate more material revenue from new indications.
雖然我們繼續投資於成長機會,但獲利能力仍然是 Novocure 的一個重要目標,也是我們正在積極努力實現的目標。一旦我們從新適應症中獲得更多實質收入,我們預計就能持續產生正調整後 EBITDA。
Cash and cash equivalents were $960 million as of December 31, 2024. As a reminder, we have a $561 million convertible note outstanding, which comes due in the fourth quarter. We believe the combination of cash on hand and funds available via our credit facility provide us with the necessary capital to pay the convertible note in full and fund operations for the foreseeable future.
截至 2024 年 12 月 31 日,現金及現金等價物為 9.6 億美元。提醒一下,我們還有價值 5.61 億美元的可轉換票據未償還,將於第四季到期。我們相信,庫存現金和透過信貸安排獲得的資金將為我們全額支付可轉換票據和為可預見的未來營運提供必要的資金。
I would like to turn the call now back to Ashley for closing comments.
現在我想將電話轉回給阿什利,請他發表最後評論。
Ashley Cordova - Chief Executive Officer
Ashley Cordova - Chief Executive Officer
Thank you, Christoph. To close, our vision is clear: we are striving to extend survival in some of the most aggressive forms of cancer. With the binary clinical events of prior years behind us, we are now focused on execution. This year marks the beginning of a new era in Novocure's journey as we evolve from a single GBM indication into a multi-indication platform company. And if we look beyond the next two years, we are only scratching the surface of what Tumor Treating Fields therapy could afford patients.
謝謝你,克里斯托夫。最後,我們的願景很明確:我們正在努力延長某些最具侵襲性的癌症患者的存活期。隨著前幾年二元臨床事件的發生,我們現在專注於執行。今年標誌著 Novocure 旅程新時代的開始,我們從單一的 GBM 適應症發展成為多適應症平台公司。如果我們展望未來兩年之後,我們僅僅觸及了腫瘤治療電場療法能為患者帶來的好處的表面。
I'll 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
Operator
(Operator Instructions) Jonathan Chang, Leerink Partners.
(操作員指示)Jonathan Chang,Leerink Partners。
Jonathan Chang - Analyst
Jonathan Chang - Analyst
Can you provide any more granularity on when and where we might see the PANOVA full data presentation? And can you provide any color on what we could learn when we get the full presentation versus the top line disclosure at the end of last year.
您能否提供更多關於何時何地可以看到 PANOVA 完整數據演示的詳細資訊?您能否詳細說明一下,當我們獲得完整的簡報與去年年底的頂線披露相比時,我們可以了解到什麼?
Ashley Cordova - Chief Executive Officer
Ashley Cordova - Chief Executive Officer
Jonathan, this is Ashley. I'll start and then Nicolas can jump in with more granularity. But the short answer is, unfortunately, we can't provide soon is what we shared as soon as we can get the PANOVA-3 out, we will. We're targeting all of the obvious conferences in the spring, but we'll be able to share more once we have converted acceptance.
喬納森,這是阿什莉。我先開始,然後 Nicolas 可以更詳細地講解。但簡短的回答是,不幸的是,我們無法很快提供我們所分享的內容,只要我們能夠推出 PANOVA-3,我們就會提供。我們的目標是參加春季的所有重要會議,但一旦獲得認可,我們就能分享更多資訊。
Nicolas Leupin - Chief Medical Officer
Nicolas Leupin - Chief Medical Officer
Yes. Thank you, Ashley. This is Nicolas. Thank you, Jonathan, for that question. I don't have much to add to this. I mean, these are really important data, and we are thrilled to present them soon.
是的。謝謝你,阿什利。這是尼古拉斯。喬納森,謝謝你提出這個問題。我對此沒有什麼可補充的。我的意思是,這些都是非常重要的數據,我們很高興很快就能展示它們。
Operator
Operator
Jason Bednar, Piper Sandler.
傑森貝德納、派珀桑德勒。
Jason Bednar - Analyst
Jason Bednar - Analyst
I wanted to start on the lung side. A lot of investor questions just around the trajectory of the lung launch after what was a pretty good start. I think a lot of us can agree in the fourth quarter, and I don't expect you to guide scripts or patients, but do you have targets on these metrics you would consider a success when we look at this year and next? And also, what does the trajectory look like in the US here as we think about the kind of the cadence of '25?
我想從肺部開始。儘管開局不錯,但許多投資者對肺部治療的後續發展軌跡提出了疑問。我認為我們很多人都會在第四季度達成一致,而且我也不指望您指導處方或患者,但是當我們展望今年和明年時,您是否對這些指標有目標,您會認為這些指標是成功的嗎?而且,當我們考慮 25 年的節奏時,美國的發展軌跡是什麼樣的?
And then if at all, I'm sorry, I'll layer on a few here, but can you talk about just the early experience of like patient compliance, doctors being repeat customers, the actual expansion of your doctor customer base in lung, anything there would be helpful.
然後,如果有的話,很抱歉,我會在這裡多說幾句,但是您能否談談早期的經驗,例如患者的依從性、醫生作為回頭客、肺部醫生客戶群的實際擴展,任何有幫助的事情。
Frank Leonard - Executive Vice President and President, Novocure Oncology
Frank Leonard - Executive Vice President and President, Novocure Oncology
Jason, this is Frank. Thank you for the questions. I'll start off in terms of talking about our objectives for the launch and how that maps out to volume growth. First, what we've said before, say it's true that we're really focused on getting the right physician with the right patient at the right time as our initial launch objective. And that's to take the learnings from GBM, we want to ensure a really strong positive first experience for the physician and the patient, which then builds confidence for that next prescription and an expansion within that physician's practice.
傑森,這是法蘭克。謝謝您的提問。我將首先談談我們此次發布的目標以及這對銷售成長有何影響。首先,正如我們之前所說,我們確實專注於在正確的時間找到正確的醫生和正確的患者作為我們最初的發布目標。這就是從 GBM 中學到的經驗教訓,我們希望確保醫生和患者擁有真正積極的首次體驗,從而為下一次開處方和擴大醫生的實踐範圍建立信心。
It also ensures that we have what I would say are really good cases to argue with the insurance companies as we move towards coverage. And that's really the second prong of our launch strategy, which is that we need to build up enough experience working with the payers that we eventually drive towards positive coverage policies with commercial payers and then turn that over into a positive Medicare coverage policy.
它還確保我們在爭取承保時擁有真正好的案例來與保險公司辯論。這實際上是我們發布策略的第二個方面,即我們需要累積足夠的與付款人合作的經驗,最終推動與商業付款人制定積極的覆蓋政策,然後將其轉變為積極的醫療保險覆蓋政策。
So all that said, we don't, as you know, we don't guide. But we are looking to build on the strong start and to build up a sufficient volume of patients this year that we have those good relationships with practices and good interactions with payers.
儘管如此,正如你所知,我們不提供指導。但我們希望在良好的開端基礎上再接再厲,今年累積足夠多的患者,以便與診所建立良好的關係,並與付款人建立良好的互動。
I think in terms of sort of give just a couple of anecdotes, you ask sort of how is the launch going, I was at the Ilac Targeted Therapies conference last week, and I was really pleased to see that in the emerging therapy section, they had included Tumor Treating Fields along with all of the other new targeted therapies that are in Phase 2 and Phase 3 programs. And I think that's an early sign that the lung cancer community has gone from not knowing about Tumor Treating Fields to being skeptical of Tumor Treating Fields perhaps at the first release to now saying, okay, let's understand this data in the context of the emerging landscape of treatment of lung cancer.
我想就舉幾個例子來說,如果你問發布會進展如何,我上週參加了 Ilac 標靶治療會議,我很高興地看到,在新興治療部分,他們已經將腫瘤治療場與處於第 2 階段和第 3 階段計劃中的所有其他新標靶療法一起納入其中。我認為這是一個早期跡象,表明肺癌界已經從對腫瘤治療場一無所知,到在第一次發佈時對腫瘤治療場持懷疑態度,到現在說,好吧,讓我們在新興的肺癌治療領域的背景下理解這些數據。
So we've been really, really pleased on that front. And happy to add additional color if there's different areas you'd like me to go into.
所以我們對此真的非常高興。如果您希望我進入不同的領域,我很樂意添加更多顏色。
Jason Bednar - Analyst
Jason Bednar - Analyst
That's helpful, Frank. I do appreciate it. Maybe one follow-up just since you kind of opened the door a little bit on the payer side. Just I think Ashley mentioned in her prepared remarks that we should have coverage wins that start to occur this year. Just how are those discussions going? Can you talk about maybe the pacing of when you expect we'll see these? What are these payers actually looking at the sides, just the data? And then within that context, can you also talk about whether you expect commercial payers in Medicare to establish new codes or to utilize existing codes from GBM when adding non-small cell lung?
這很有幫助,弗蘭克。我非常感激。也許只需要一個後續行動,因為你在付款方稍微打開了大門。我只是認為阿什利在她準備好的演講中提到,我們應該在今年開始取得報導上的勝利。這些討論進展如何?您能否談談我們預計何時能看到這些內容?這些付款人實際上關注的是什麼?僅僅關注數據嗎?然後在此背景下,您還可以談談您是否希望醫療保險中的商業付款人在添加非小細胞肺時建立新的代碼或利用 GBM 的現有代碼?
Frank Leonard - Executive Vice President and President, Novocure Oncology
Frank Leonard - Executive Vice President and President, Novocure Oncology
Yes. So I'd say -- so first, it's too early to comment on payer interactions just because it's -- we're talking about the initial 20 patient cohort. But I would say that -- or to comment in detail, but what I can say at a high level is that it's above our expectations so far. So we feel like we're in a good -- on a good path with the payers. They really are. It's a focus. What are the payers looking at, I think, first and foremost, it's the same thing that physicians look at, which is that there's a complete unmet need for treatment in the second line for non-small cell lung cancer in Stage 4. So that's always a good place to start with payers.
是的。所以我想說——首先,現在評論付款人互動還為時過早,因為——我們談論的是最初的 20 名患者群體。但我想說的是——或者詳細評論一下,但我可以從高層次上說的是,到目前為止,它超出了我們的預期。因此,我們覺得我們與付款人的關係很好。確實如此。這是一個焦點。我認為,付款人首先關注的是什麼,這與醫生關注的是同一個問題,即第四階段非小細胞肺癌的二線治療需求完全未得到滿足。因此,對於付款人來說,這始終是一個好的起點。
In terms of the -- then in terms of just the general trajectory with payers, what we've said consistently is that we think it will take us about one to two years with the commercial payers to build up coverage policies and that Medicare would lag about a year behind that, and that's still what we're thinking.
就付款人的整體發展軌跡而言,我們一直說的是,我們認為與商業付款人一起建立覆蓋政策需要大約一到兩年的時間,而醫療保險將落後大約一年,這仍然是我們的想法。
Ashley Cordova - Chief Executive Officer
Ashley Cordova - Chief Executive Officer
The only other thing I would add is this is the beauty of having a multi-indication platform is we get to leverage our experience and the knowledge that we built up in GBM directly into the lung cancer indication. So this is a process we know how to do, and we're doing it with the same team that have so successfully executed in GBM.
我唯一想補充的是,擁有多適應症平台的美妙之處在於,我們可以將我們在 GBM 領域累積的經驗和知識直接應用到肺癌適應症中。所以,我們知道如何執行此流程,我們正在與在 GBM 中成功執行的同一團隊一起執行此流程。
Jason Bednar - Analyst
Jason Bednar - Analyst
Sorry. Anything on the coding?
對不起。關於編碼有什麼資訊嗎?
Frank Leonard - Executive Vice President and President, Novocure Oncology
Frank Leonard - Executive Vice President and President, Novocure Oncology
That's right. Sorry, I really didn't answer that part. Thank Jason. On the codes, we expect to utilize the same -- we are utilizing the same code and expect to continue to do so.
這是正確的。抱歉,我確實沒有回答那部分。謝謝傑森。對於程式碼,我們希望使用相同的——我們正在使用相同的程式碼,並希望繼續這樣做。
Operator
Operator
Larry Biegelsen, Wells Fargo.
富國銀行的拉里·比格爾森。
Lei Huang - Analyst
Lei Huang - Analyst
It's Lei calling in for Larry. Just first, on this call so far, you mentioned several times about improved US approval rates that contribute to revenue in 2024. Can you give any more color on how much that improvement was as far as revenue or revenue growth and if we could see that improve further in 2025?
是雷為拉里打來的。首先,到目前為止,在這次電話會議上,您多次提到美國批准率的提高將有助於 2024 年的收入。您能否詳細說明收入或收入成長的改善程度,以及我們是否會在 2025 年看到進一步改善?
And related to that, in '24, you had some benefit from collections in the US revenue. And any thoughts on how we should think about in 2025? I guess, really looking at it bigger picture is when you look at consensus, is there anything the Street might be missing on either those points or any other factors? And I have a follow-up.
與此相關的是,在 24 年,您從美國稅收中獲得了一些利益。對於我們應該如何展望 2025 年,您有何看法?我想,真正從更大的角度來看待共識,華爾街在這些觀點或其他因素上是否可能忽略了什麼?我還有一個後續問題。
Christoph Brackmann - Chief Financial Officer
Christoph Brackmann - Chief Financial Officer
Yes. Thank you for the question. This is Christoph. So happy to provide some color on this. Growth in 2024 in total from improved approval rates was $42 million, driven by the US. Now, $22 million of that was from prior periods, so sort of a one-off windfall that we had in the prior year.
是的。謝謝你的提問。這是克里斯托夫。很高興能對此提供一些資訊。在美國的推動下,2024 年批准率提高帶來的總成長為 4,200 萬美元。其中 2,200 萬美元來自前期,可以說是我們前一年獲得的一次性意外之財。
Going forward, we do not comment on the exact level of approval rates, but it is at a level where we believe there is not much room for improvement. And hence, we do not expect similar impacts going forward. And that's what we said in the prepared remarks, we expect the growth to be in line with Optune Gio active patients growth. And I think that probably answers your question.
展望未來,我們不會對支持率的具體水平發表評論,但我們認為目前的支持率水準沒有太大的提升空間。因此,我們預計未來不會出現類似的影響。這就是我們在準備好的評論中所說的,我們預計成長將與 Optune Gio 活躍患者的成長保持一致。我想這可能回答了你的問題。
Ashley Cordova - Chief Executive Officer
Ashley Cordova - Chief Executive Officer
And we do think, I think this is fairly well reflected in the model.
我們確實認為,我認為這在模型中得到了很好的反映。
Lei Huang - Analyst
Lei Huang - Analyst
Got it. And just for my follow-up, you mentioned that -- you mentioned the METIS and PANOVA publication. Should we expect these 25 or 26. Can you share that? And related to that, you mentioned filings for both later this year. That's probably a little later than we expected. Are you just being conservative there? Is anything we should think about as far as the process?
知道了。就我的後續問題而言,您提到了——您提到了 METIS 和 PANOVA 出版物。我們該期待這 25 還是 26?能分享一下嗎?與此相關,您提到了今年稍後將提交的兩份文件。這可能比我們預期的要晚一點。您只是在那裡保持保守嗎?就這個過程而言,我們需要考慮什麼嗎?
Ashley Cordova - Chief Executive Officer
Ashley Cordova - Chief Executive Officer
Yes. No, I think I'll start there. So the short answer is, yes, you should expect publication this year in process to finalizing these submissions. We're finalizing the manuscript drafts, and they'll go in. And we are in the process of having active pre-submission discussions with the FDA. We have breakthrough device designation on both of these indications, which provides us the opportunity to go back and forth with some interactive review questions prior to the formal filing, and we're in that process right now.
是的。不,我想我會從那裡開始。因此,簡短的回答是,是的,您應該預計今年將會出版並最終完成這些提交。我們正在完成手稿草稿,然後它們就會被提交。我們正在與 FDA 進行積極的提交前討論。我們在這兩種適應症上都獲得了突破性的設備指定,這為我們提供了在正式提交申請之前反复討論一些互動審查問題的機會,我們現在正處於這一過程中。
So I wouldn't read anything into timing other than the fact that we're in that kind of pre-sub process. right now, and we'll move it through to filing as soon as possible, but this is an area that probably go slow to go fast, and we're in the interactive review part of the process right now.
因此,除了我們正處於那種預先訂購流程之外,我不會對時間做出任何解讀。現在,我們會盡快將其提交備案,但這是一個可能進展緩慢的領域,我們現在正處於流程的互動式審查部分。
I do think it's important why we talk about the milestones to ground everybody, though, in the data and the TAM, right? These are both indications where we have a significant unmet need where there is the first advance ever for these specific populations reflected in the breakthrough device designation. And both of these provide a TAM expansion opportunity that is a multiple of what we have in GBM. And as you look at the three in aggregate, you've heard us say many times before, 7 times the GBM opportunity.
我確實認為,我們談論里程碑是為了讓每個人都了解數據和 TAM,這很重要,對嗎?這兩個跡像都表明,我們有一個重大的未滿足需求,而突破性設備名稱反映了這些特定人群的首次進步。這兩者都提供了 TAM 擴展機會,是 GBM 的數倍。當你把這三者放在一起看時,你會發現我們之前已經多次提到過,GBM 機會是 7 倍。
So we are as eager to get these in markets as you all are to have us have them in market because it is a real transformative opportunity for the company.
因此,我們和你們一樣渴望將這些產品推向市場,因為這對公司來說是一個真正的轉型機會。
Operator
Operator
Vijay Kumar, Evercore ISI.
維傑·庫馬爾(Vijay Kumar),Evercore ISI。
Vijay Kumar - Analyst
Vijay Kumar - Analyst
My first one was on the long side, 52 prescriptions in that Q4. Should we model a sequential step up throughout the year when you look at that 52 starting point and 20 active patients? And any goalpost on what percentage of covered lives should we expect to have some sort of coverage by end of '25, end of '26, et cetera?
我的第一筆處方是長期的,第四季有 52 份處方。當您看到 52 個起點和 20 個活躍患者時,我們是否應該在全年模擬連續的提升?到 2025 年底、2026 年底等等,我們預計有多少比例的受保人次能夠獲得某種形式的保險?
Ashley Cordova - Chief Executive Officer
Ashley Cordova - Chief Executive Officer
Yes. It's probably too soon for us to give you specific numbers, Vijay. You'll see a track out. What we'll say is that certainly, you should expect it to grow throughout the course of the year. This is a growth -- this is a launch, right? So you would expect these numbers to trend up.
是的。維傑,現在給你具體的數字可能還為時過早。您會看到一條出路。我們要說的是,你當然應該預期它會在全年內成長。這是一種成長──這是一種啟動,對嗎?因此,你會預期這些數字會呈現上升趨勢。
In terms of pace, what we will say is we're pleased, and it's in line with expectation, but it is focused on the right patient right time. And the same with the payer, we'll let you know as soon as we have enough track record to give you an anchor number, but we're not there yet. We would expect to exit those '25 with substantial experience to drive revenue in '26.
就速度而言,我們會說我們很高興,這符合預期,但它的重點是合適的時間合適的患者。對於付款人也是一樣,一旦我們有足夠的記錄來給您一個錨定號碼,我們就會通知您,但我們還沒有做到這一點。我們期望那些擁有豐富經驗的 25 名員工能夠在 26 年推動營收成長。
And then maybe, Frank, anything you can add on.
然後也許,弗蘭克,你可以添加任何內容。
Frank Leonard - Executive Vice President and President, Novocure Oncology
Frank Leonard - Executive Vice President and President, Novocure Oncology
Yes, Vijay, thanks for the question. I'd just add in terms of color on the launch, what we're really looking at right now is the is the interactions we're having with our physicians and the patient profiles that are coming in. And what we're really pleased with is that we're seeing patients getting Tumor Treating Fields plus immune checkpoint inhibitors, which to us is a good sign because we know that's a robust market.
是的,維傑,謝謝你的提問。我只是想在發布會上補充一下顏色,我們現在真正關注的是我們與醫生的互動以及即將到來的患者資料。我們真正高興的是,我們看到患者正在接受腫瘤治療場加上免疫檢查點抑制劑的治療,這對我們來說是一個好兆頭,因為我們知道這是一個強勁的市場。
Vijay Kumar - Analyst
Vijay Kumar - Analyst
Understood. And sorry, just when you make the comments substantial revenues in '26, safe to assume at least 1/4 of covered lives are under some sort of coverage exiting '25. Would that be a sensible assumption?
明白了。抱歉,就在您評論 26 年收入可觀的時候,可以安全地假設至少有四分之一的受保人員在 25 年結束時處於某種保險範圍內。這是一個合理的假設嗎?
Ashley Cordova - Chief Executive Officer
Ashley Cordova - Chief Executive Officer
Fortunately, we're not going to be able to give you an anchor number. What we have said in the past, Vijay, is that commercial will come first. We expect that to work through the system in '25, and commercial is about 25% of the cancer opportunity. So those are statements you can't incur to.
幸運的是,我們無法提供您錨點號碼。維傑,我們過去說過,商業將放在第一位。我們預計該系統將在 25 年內發揮作用,商業化約佔癌症發生率的 25%。所以這些都是你無法承受的言論。
Vijay Kumar - Analyst
Vijay Kumar - Analyst
Understood. Then a couple of P&L questions, one on China. Q4 revenues declined sequentially. Was that a timing element? Maybe talk about what's happening in China?
明白了。然後是幾個損益問題,其中一個關於中國。第四季營收季減。這是時間因素嗎?也許可以談談中國正在發生的事情?
Ashley Cordova - Chief Executive Officer
Ashley Cordova - Chief Executive Officer
I'd say that has more to do with the ending of the amortization of the royalty. They are -- let me remind everybody that, that China number includes both their purchases for future product or royalty on sales and the amortization of other royalties in that agreement. And I would say it's largely driven by timing and purchases and the roll-off of the amortization.
我認為這與版稅攤銷的結束有更大的關係。他們是——讓我提醒大家,中國的數字包括他們未來產品的購買或銷售特許權使用費以及該協議中其他特許權使用費的攤銷。我想說的是,這很大程度上是由時間、購買和攤銷的滾動所驅動的。
Vijay Kumar - Analyst
Vijay Kumar - Analyst
Sorry. So we just -- when you look forward, actually, is the fiscal 2024 revenue base for China, should that grow? Or is that like flattish or should that be down?
對不起。所以我們只是——當你展望未來時,實際上,中國 2024 財年的營收基礎應該會成長嗎?或者說它是平的還是應該向下?
Ashley Cordova - Chief Executive Officer
Ashley Cordova - Chief Executive Officer
What I will say is you should look at Q4 as the baseline that doesn't include then the royalty, so that's a good baseline, and then I would kick to buy to answer their expectations about growth.
我想說的是,你應該將第四季度視為不包括版稅的基準,因此這是一個很好的基準,然後我會開始購買以回答他們對成長的期望。
Vijay Kumar - Analyst
Vijay Kumar - Analyst
Understood. And then maybe one on margins for cash flow. I think you mentioned gross margin should be down for fiscal '25 given the new launches. Can you quantify that? I think related, you said OpEx to step up. Is the step-up in OpEx, should that be in line with revenues, above revenues? And what are the implication of free cash flows if gross margins are down and OpEx is stepping up?
明白了。然後也許還有一個關於現金流利潤率的問題。我認為您提到,考慮到新產品的推出,25 財年的毛利率應該會下降。你能量化嗎?我認為相關,您說 OpEx 要加強。營運支出的成長是否應該與收入一致,還是高於收入?如果毛利率下降而營運成本上升,自由現金流會受到什麼影響?
Christoph Brackmann - Chief Financial Officer
Christoph Brackmann - Chief Financial Officer
Yes. Vijay, Christoph, I can take that. So on maybe gross margin first. The gross margin in the quarter but also for the year was -- the quarter was 79%, year was 77%, benefited from the increased approval rates and specifically also from the benefit that we had from prior period claims. So for the full year, that was $22 million. If you adjust that on gross margin, you would be looking at gross margins in the mid-70s, and I think that's a good sort of anchor.
是的。維傑、克里斯托夫,我可以接受。因此首先要考慮的是毛利率。本季以及全年的毛利率為 - 本季度為 79%,全年為 77%,受益於批准率的提高,特別是受益於我們從前期索賠中獲得的收益。所以全年的收入是 2200 萬美元。如果你根據毛利率進行調整,你會看到毛利率在 70 年代中期,我認為這是一個很好的基準。
Now, what we also said in 2025, we expect headwinds on gross margin from two sides. One is the rollout of the new head array, which is lighter and thinner and more flexible. So a significant benefit to our patients, but it comes at this point at a higher cost. So as we roll this out in the US, there will be a headwind on gross margin. And the second headwind on gross margin is on the launch of the -- on the lung side, as we go at risk and prepare for or negotiate for payer coverage, that's the impact on gross margin.
現在,我們也說過,我們預期 2025 年毛利率將面臨來自兩方面的阻力。一是推出新型頭部陣列,更輕、更薄、更靈活。因此,這對我們的患者來說是一個很大的好處,但目前的成本也較高。因此,當我們在美國推出這項服務時,毛利率將會面臨阻力。毛利率面臨的第二個不利因素是肺部治療的推出,因為我們面臨風險,需要為付款人承保做準備或進行談判,這將對毛利率產生影響。
So long story short, we expect the gross margin to get closer to the lower 70s. It's a temporary effect, and we would then expect it to revert. On the expense side, as we are in launch mode, we would expect some incremental expenses on -- particularly on the sales and marketing side. And on the G&A side, it's very moderate to flattish. Yes.
長話短說,我們預計毛利率將接近 70% 以下。這只是暫時的影響,我們預計它會恢復。在費用方面,由於我們處於啟動模式,我們預計會有一些增量費用 - 特別是在銷售和行銷方面。在一般及行政開支方面,成長非常溫和甚至持平。是的。
Ashley Cordova - Chief Executive Officer
Ashley Cordova - Chief Executive Officer
But I would just reiterate that we feel confident that we have the financial strength and the cash balance that we need to kind of get through these growth periods.
但我只想重申,我們有信心,我們擁有度過這些增長期所需的財務實力和現金餘額。
Operator
Operator
Jessica Fye, JPMorgan.
潔西卡費伊(Jessica Fye),摩根大通。
Tanmay Patwardhan - Analyst
Tanmay Patwardhan - Analyst
This is Tanmay on for Jess. Could you talk about what's the current number of active patients on option for lung cancer in the US? And how does it compare to 20 active patients you reported at the end of 2024? And also maybe a comment on what factors do you think are driving or hindering that patient adoption here? Thank you.
這是 Tanmay 為 Jess 表演的。您能談談目前美國接受肺癌治療的活躍患者數量是多少嗎?與 2024 年底您報告的 20 名活躍患者相比如何?另外,您認為哪些因素正在推動或阻礙患者接受這種療法?謝謝。
Frank Leonard - Executive Vice President and President, Novocure Oncology
Frank Leonard - Executive Vice President and President, Novocure Oncology
Yes. So I think first off, we don't comment on progress intra-quarter. So I can't comment on additions from the 20 patients at year-end. But what I can in terms of the concept of the -- in terms of commenting on what we think is driving the adoption rate, I just highlighted an anecdote or a story that I was able to interact last week with two different physicians who are now multi-indication physicians for Novocure and tumor treat field.
是的。所以我認為首先我們不會對季度內的進展發表評論。所以我無法對年底新增的 20 名患者的情況發表評論。但是,就概念而言,就我們認為推動採用率的因素而言,我只能強調一個軼事或故事,我上週與兩位不同的醫生進行了交流,他們現在是 Novocure 和腫瘤治療領域的多適應症醫生。
So they're -- they treated patients with glioblastoma had long-term success stories. Both then participated in medical oncology trials for us with PANOVA and [WUNAR]. And these two physicians now both have patients being treated on prescription order for lung cancer as well as patients in clinical trials for GBM or for other indications. And so I think we're seeing the early benefits of being a multi-indication company, and that's really exciting for us.
因此,他們治療的膠質母細胞瘤患者均取得了長期成功。隨後,兩人都參加了我們利用 PANOVA 進行的腫瘤醫學試驗,[烏納爾]。目前,這兩位醫生都為肺癌患者提供處方治療,同時也為膠質母細胞瘤或其他疾病的臨床試驗患者提供治療。因此,我認為我們看到了成為多適應症公司所帶來的早期好處,這對我們來說真的令人興奮。
Tanmay Patwardhan - Analyst
Tanmay Patwardhan - Analyst
Great. And maybe if I can squeeze in one more. How do you think about the drivers for revenue growth in 2025? Maybe a comment on that would be really helpful.
偉大的。也許我還能再擠一點時間。您如何看待2025年營收成長的驅動力?也許對此發表評論會很有幫助。
Ashley Cordova - Chief Executive Officer
Ashley Cordova - Chief Executive Officer
Yes. I would say '25 is really going to be a kind of demand-generation year, which will unlock material revenue contribution in '26, which will come principally from the lung cancer indication. Again, we've reminded everybody that GBM is a very solid foundation that funds our investments in R&D, but that the real unlock in growth will come from the launch in lung. And then as we look ahead in 2016, we'll layer on Medicine PANOVA there with those launches. '25 is the demand generation here.
是的。我想說 25 年實際上將會是一個需求創造年,它將在 26 年釋放實質的收入貢獻,這主要來自肺癌適應症。我們再次提醒大家,GBM 是資助我們在研發方面投資的非常堅實的基礎,但真正的成長釋放將來自於肺部的推出。展望 2016 年,我們將透過這些發佈在 Medicine PANOVA 上。 '25 是這裡的需求生成。
Operator
Operator
Emily Bodnar, H.C. Wainwright.
艾米麗·博德納,H.C.溫賴特。
Emily Bodnar - Analyst
Emily Bodnar - Analyst
I guess the first one on the lung launch. With the initial patient oversee prescriptions, are they mainly like PD-1-naive patients, people in experienced patients? And then are you seeing patients who have -- or taking docetaxel and PD-1 inhibitors? Or is it mostly one or the other?
我猜是第一個進行肺發射的人。對於初始患者監督處方,他們是否主要像 PD-1 初治患者、有經驗的患者一樣?那麼,您是否見過正在服用多西他賽和 PD-1 抑制劑的患者?或主要是其中之一?
Frank Leonard - Executive Vice President and President, Novocure Oncology
Frank Leonard - Executive Vice President and President, Novocure Oncology
Yes. So I think -- thank you for the question. This is Frank. We are seeing -- what I'll comment on is to say that we are seeing patients receive both docetaxel and immune checkpoint inhibitors concurrent with tumor treated field. So we're seeing both populations.
是的。所以我認為——感謝您的提問。這是弗蘭克。我們看到——我要評論的是,我們看到患者在接受腫瘤治療的同時接受多西他賽和免疫檢查點抑制劑治療。所以我們看到了兩種人群。
We are also seeing retreatment with ICI or continuation of treatment for patients who have had ICI in the front line. And overall, we're seeing, what I would describe as a good demographic mix of patients. So I wouldn't go much further than that right now other than to say that those key metrics that we look at all balanced in the right direction.
我們也看到使用 ICI 進行再治療或繼續對已接受 ICI 一線治療的患者進行治療。總體而言,我們看到了良好的患者人口結構。因此,我現在不會做更多闡述,只能說我們所關注的那些關鍵指標都朝著正確的方向平衡。
Operator
Operator
And I'm currently showing no further questions at this time. I'd like to hand the call back over to Bill Doyle for closing remarks.
目前我沒有其他問題。我想將電話轉回給比爾·道爾,請他做最後發言。
William Doyle - Executive Chairman of the Board
William Doyle - Executive Chairman of the Board
So I'd like to conclude this call, as I always do, by first thanking all of our Novocure colleagues for their hard work and their dedication to our patients. And I'd like to thank you for your continued interest in Novocure.
因此,在結束本次電話會議之前,我想像往常一樣,首先感謝所有 Novocure 同事的辛勤工作以及他們對患者的奉獻。我要感謝您對 Novocure 的持續關注。
This is actually my 36th earnings call since our IPO in 2015, and I believe it marks a true pivot, a true moment in history of this company. As I was reflecting on the script, as we were editing it and putting it together, this next chapter, as we move and grow from our foundation in GBM to a global multi-indication cancer company is something I think that all of us should be proud of and excited for as we continue to pursue our mission to help patients extend their survival with some of the most aggressive forms of cancer. So thank you.
這實際上是自 2015 年 IPO 以來我召開的第 36 次財報電話會議,我相信這標誌著公司真正的轉折點,是公司歷史上的真正時刻。當我在思考劇本時,當我們在編輯和整理劇本時,我認為,當我們從膠質母細胞瘤 (GBM) 的基礎發展成為一家全球多適應症癌症公司時,我們所有人都應該為此感到自豪和興奮,因為我們將繼續追求我們的使命,幫助患有某些最具侵襲性的癌症的患者生存期。所以謝謝你。
Operator
Operator
This concludes today's conference call. Thank you for your participation. 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。