Novocure Ltd (NVCR) 2023 Q2 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Novocure Q2 2023 Earnings Conference Call. (Operator Instructions). Please be advised that today's conference is being recorded.

美好的一天，感謝您的支持。歡迎參加 Novocure 2023 年第二季度收益電話會議。 （操作員說明）。請注意，今天的會議正在錄製中。

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

我現在想把會議交給今天的發言人英格麗德·戈德堡。請繼續。

Good morning, everyone. Thank you for joining us to review Novocure's second quarter 2023 performance. I'm on the phone this morning with our Executive Chairman, Bill Doyle; our CEO, Asaf Danziger; and our CFO, Ashley Cordova. Other members of our executive leadership team are also on the call and available for Q&A. For your reference, slides accompanying this earnings release can be found on our website, www.novocure.com, on our Investor Relations page under quarterly reports.

大家，早安。感謝您與我們一起回顧 Novocure 2023 年第二季度的業績。今天早上我正在與我們的執行主席比爾·多伊爾通電話；我們的首席執行官 Asaf Danziger；以及我們的首席財務官阿什利·科爾多瓦 (Ashley Cordova)。我們執行領導團隊的其他成員也隨時待命並接受問答。為了供您參考，本財報隨附的幻燈片可以在我們的網站 www.novocure.com 的季度報告下的投資者關係頁面上找到。

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

在開始之前，我想提醒您，我們在本次電話會議期間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存在重大差異。這些聲明涉及許多風險和不確定性，其中一些風險和不確定性超出了我們的控制範圍，並且會不時在我們向 SEC 提交的文件中進行描述。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 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 noncash items and best reflects the financial value generated by our business.

在適當的情況下，我們將參考非 GAAP 財務指標來評估我們的業務，特別是調整後的 EBITDA，即扣除利息、稅項、折舊、攤銷和股權激勵之前的盈利指標。我們認為調整後的 EBITDA 是一個重要指標，因為它消除了我們的資本結構、稅率和重大非現金項目對盈利的影響，並最好地反映了我們業務產生的財務價值。

Reconciliations of non-GAAP to GAAP financial measures are included in our press release, earnings slides and in our Form 8-K filed with the SEC today. These materials can also be accessed from the Investor Relations page of our website. Following our prepared remarks today, we will open the line for your questions.

我們的新聞稿、收益幻燈片以及今天向 SEC 提交的 8-K 表格中包含了非 GAAP 與 GAAP 財務指標的調節表。這些材料也可以從我們網站的投資者關係頁面訪問。在我們今天準備好的發言之後，我們將開通您的提問熱線。

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

我現在將把電話轉給我們的執行主席比爾·多伊爾。

Thank you, Ingrid, and good morning. At Novocure, our mission is to extend survival in some of the most aggressive forms of cancer through the development and commercialization of Tumor Treating Fields. Since our founding, our commercial efforts have focused on treating patients with glioblastoma. The second quarter marked the beginning of a transformational period for Novocure as we moved beyond the brain with the presentation of data from our first randomized Phase III trial in the torso.

謝謝你，英格麗德，早上好。在 Novocure，我們的使命是通過腫瘤治療領域的開發和商業化來延長一些最具侵襲性的癌症形式的生存期。自成立以來，我們的商業努力一直集中在治療膠質母細胞瘤患者。第二季度標誌著 Novocure 轉型期的開始，我們超越了大腦，展示了第一個軀幹隨機 III 期試驗的數據。

On today's call, we will begin with a discussion of the LUNAR trial and other upcoming clinical catalysts, followed by a review of our commercial and financial performance in the quarter. In June, we took a meaningful step toward bringing Tumor Treating Fields therapy to patients with high unmet need in lung cancer. At the American Society of Clinical Oncology Annual Meeting, Dr. Ticiana Leal of Emory University presented the results of the Phase III LUNAR clinical trial. The LUNAR trial studied the use of TTFields therapy together with standard of care therapies for the treatment of stage 4 metastatic non-small cell lung cancer following platinum failure.

在今天的電話會議上，我們將首先討論 LUNAR 試驗和其他即將推出的臨床催化劑，然後回顧我們本季度的商業和財務業績。六月，我們邁出了有意義的一步，為肺癌治療需求未得到滿足的患者提供腫瘤電場治療。在美國臨床腫瘤學會年會上，埃默里大學的Ticiana Leal博士介紹了III期LUNAR臨床試驗的結果。 LUNAR 試驗研究了使用 TTFields 療法與標準護理療法一起治療鉑類失敗後的 4 期轉移性非小細胞肺癌。

The LUNAR trial met its primary endpoint, exhibiting a statistically significant improvement in overall survival, from 9.9 months to 13.2 months for patients treated with TTFields and standard of care therapy, compared to treatment with standard of care therapy alone. The clinically meaningful 3-month survival improvement was achieved without increased systemic toxicity. In addition to meeting its primary survival endpoint, LUNAR also met a key secondary endpoint, demonstrating 18.5 months median overall survival for patients treated with TTFields and immune checkpoint inhibitors. This compares to a 10.8 months overall survival for patients treated with immune checkpoint inhibitors alone.

LUNAR 試驗達到了主要終點，與單獨使用標準護理治療相比，接受 TTFields 和標準護理治療的患者的總生存期從 9.9 個月提高到 13.2 個月，具有統計學意義。在沒有增加全身毒性的情況下，實現了具有臨床意義的 3 個月生存率改善。除了達到主要生存終點外，LUNAR 還達到了一個關鍵的次要終點，即接受 TTFields 和免疫檢查點抑製劑治療的患者的中位總生存期為 18.5 個月。相比之下，僅接受免疫檢查點抑製劑治療的患者的總生存期為 10.8 個月。

I want to highlight and directly address the most frequent questions received from investors regarding the LUNAR trial results. Globally, TPS data was collected for 55% of patients enrolled in LUNAR and was balanced across the 4 cohorts and was consistent with expected wild-type expression. In the U.S., TPS expression was measured for 83% of LUNAR enrollees and was balanced across the cohorts and was consistent with expected wild-type expression. The Kaplan-Meier curves for patients with measured TPS scores are nearly identical to the Kaplan-Meier curves for patients without measured TPS scores, underlying the potency of the survival data regardless of PD-L1 status.

我想強調並直接回答投資者提出的有關 LUNAR 試驗結果的最常見問題。在全球範圍內，收集了 55% 參加 LUNAR 的患者的 TPS 數據，該數據在 4 個隊列中保持平衡，並且與預期的野生型表達一致。在美國，83% 的 LUNAR 參與者測量了 TPS 表達，並且在各隊列中保持平衡，並且與預期的野生型表達一致。測量 TPS 評分的患者的 Kaplan-Meier 曲線與未測量 TPS 評分的患者的 Kaplan-Meier 曲線幾乎相同，這表明無論 PD-L1 狀態如何，生存數據的效力都是如此。

We have also fielded questions regarding the difference between the effect size in overall survival and progression-free survival. This observed difference is not uncommon in trial studying immune checkpoint inhibitors and is in-line with the results from a number of the leading immune checkpoint inhibitor trials in this setting. Overall survival is generally considered the gold standard endpoint in oncology.

我們還提出了有關總生存期和無進展生存期的效應大小差異的問題。這種觀察到的差異在研究免疫檢查點抑製劑的試驗中並不罕見，並且與該領域許多領先的免疫檢查點抑製劑試驗的結果一致。總生存期通常被認為是腫瘤學的金標準終點。

Finally, I would like to address the clinical applicability of the LUNAR results. One of the most exciting and rewarding aspects of dedicating one's career to extending the lives of cancer patients is witnessing the improvements in outcomes with evolving standards of care. While we have seen a shift in the first-line treatment for patients with metastatic non-small cell lung cancer to immune checkpoint inhibitors, there remains an immense unmet need for effective low toxicity treatment options in the second line.

最後，我想談談 LUNAR 結果的臨床適用性。將自己的職業生涯奉獻給延長癌症患者的生命，最令人興奮和最有價值的方面之一就是見證護理標準不斷發展帶來的結果改善。雖然我們已經看到轉移性非小細胞肺癌患者的一線治療轉向免疫檢查點抑製劑，但二線有效的低毒性治療方案仍然存在巨大的未滿足需求。

There are a few differentiated therapeutic options for second-line treatment of stage 4 non-small cell lung cancer. The most recent meaningful survival breakthrough occurred over 7 years ago when pembrolizumab was introduced. Since then, there have been several clinical trials evaluating the efficacy of other immune checkpoint inhibitors, but none of these trials have meaningfully moved the needle further.

4 期非小細胞肺癌的二線治療有幾種差異化的治療選擇。最近一次有意義的生存突破發生在 7 年前，當時派姆單抗 (pembrolizumab) 被推出。從那時起，已有多項臨床試驗評估其他免疫檢查點抑製劑的功效，但這些試驗都沒有取得進一步的進展。

LUNAR is the first Phase III clinical trial in over 7 years to show a clinically meaningful extension in overall survival in second-line treatment of stage 4 non-small cell lung cancer. We are pleased with the clinical outcome of the LUNAR study and believe TTFields will provide a much-needed new treatment option for patients and thoracic oncologists in need of therapies that materially extend the overall survival without adding systemic toxicity. We are confident TTFields therapy has a place in the current and future standards of care for second-line treatment of stage 4 non-small cell lung cancer. We are pleased to announce that the LUNAR study results have been accepted to a high-impact journal, and we are now awaiting publication.

LUNAR 是 7 年來第一個 III 期臨床試驗，顯示 4 期非小細胞肺癌二線治療的總體生存期具有臨床意義。我們對 LUNAR 研究的臨床結果感到滿意，並相信 TTFields 將為需要顯著延長總體生存期且不增加全身毒性的治療的患者和胸部腫瘤科醫生提供急需的新治療選擇。我們相信 TTFields 療法在當前和未來 4 期非小細胞肺癌二線治療的護理標準中佔有一席之地。我們很高興地宣布，LUNAR 研究結果已被一家高影響力期刊接受，我們現在正在等待發表。

Further, our regulatory team recently completed the LUNAR submission for CE mark. Our next step is to finalize our FDA PMA submission later this year. We plan to pursue a label consistent with the primary endpoint of the trial, TTFields, together with standard therapies for second-line treatment of stage 4 non-small cell lung cancer.

此外，我們的監管團隊最近完成了 LUNAR 的 CE 標誌提交。我們的下一步是在今年晚些時候完成 FDA PMA 提交。我們計劃尋求與試驗主要終點 TTFields 一致的標籤，以及用於 4 期非小細胞肺癌二線治療的標準療法。

To supplement the LUNAR results presented at ASCO, we are conducting additional analyses, which will further elucidate many key aspects of the trial. These analyses will include in and out-of-field progression patterns and patient survival is a function of usage and TPS score. Additional trial insights will further arm physicians with key data when evaluating the best opportunities to leverage our TTFields therapy once approved. We expect to present these analyses before year-end.

為了補充 ASCO 上公佈的 LUNAR 結果，我們正在進行額外的分析，這將進一步闡明該試驗的許多關鍵方面。這些分析將包括場內和場外進展模式，並且患者生存率是使用情況和 TPS 評分的函數。一旦獲得批准，在評估利用我們的 TTFields 療法的最佳機會時，額外的試驗見解將進一步為醫生提供關鍵數據。我們預計在年底前提交這些分析。

Insights gained from the LUNAR trial will serve as the foundation for the next large randomized clinical trials studying TTFields in non-small cell lung cancer. As announced at ASCO, our next trial will explore the use of TTFields in earlier lines of therapy and in new therapeutic concomitant regimes. Specifically, I would like to highlight the Phase III LUNAR-2 trial, which will study the first-line use of TTFields concomitant with pembrolizumab and platinum-based chemotherapy for patients with metastatic non-small cell lung cancer.

從 LUNAR 試驗中獲得的見解將成為下一個研究 TTFields 在非小細胞肺癌中的大型隨機臨床試驗的基礎。正如在 ASCO 上宣布的那樣，我們的下一項試驗將探索 TTFields 在早期治療方案和新治療伴隨方案中的使用。具體來說，我想重點介紹 III 期 LUNAR-2 試驗，該試驗將研究 TTFields 聯合派姆單抗和鉑類化療對轉移性非小細胞肺癌患者的一線使用。

The FDA approved the IDE for LUNAR-2, and we are currently preparing sites for initiation. LUNAR-2 will be a randomized global trial designed to enroll 734 patients with a 21-month follow-up period after the last patient enrolled. Primary endpoints will be overall survival and progression-free survival. The LUNAR-2 trial is an important next step in our lung cancer program, and we look forward to providing updates in the coming quarters as we work to bring Tumor Treating Fields therapy to patients in need.

FDA 批准了 LUNAR-2 的 IDE，我們目前正在準備啟動地點。 LUNAR-2 將是一項隨機全球試驗，旨在招募 734 名患者，並在最後一名患者招募後進行 21 個月的隨訪。主要終點是總生存期和無進展生存期。 LUNAR-2 試驗是我們肺癌項目的重要下一步，我們期待在未來幾個季度提供最新進展，努力為有需要的患者提供腫瘤治療電場療法。

With that, I will turn the call over to Asaf to discuss other clinical updates as well as our commercial performance in the second quarter.

這樣，我將把電話轉給 Asaf，討論其他臨床更新以及我們第二季度的商業表現。

Thank you, Bill. I would like to underline Bill's enthusiasm and confidence in the LUNAR trial results. The LUNAR data are the culmination of nearly a decade of effort from patients, investigators and the Novocure team. The overall survival data presented at ASCO have the potential to impact thousands of lives. We are eager to do everything in our power to reach those patients who can benefit.

謝謝你，比爾。我想強調比爾對 LUNAR 試驗結果的熱情和信心。 LUNAR 數據是患者、研究人員和 Novocure 團隊近十年努力的結晶。 ASCO 公佈的總體生存數據有可能影響數千人的生命。我們渴望盡一切努力幫助那些能夠受益的患者。

As a reminder, LUNAR is the first of 4 Phase III trials that are fully enrolled and will read out over the next 18 months. Later this summer, we expect to release top line results from the Phase III INNOVATE-3 trial exploring the use of TTFields with weekly paclitaxel in platinum-resistant ovarian cancer. The INNOVATE-3 top line will be followed by a presentation of the full INNOVATE-3 data later this year.

需要提醒的是，LUNAR 是 4 項 III 期試驗中的第一項，該試驗已全部入組，並將在未來 18 個月內讀出結果。今年夏天晚些時候，我們預計將發布 III 期 INNOVATE-3 試驗的主要結果，該試驗探索使用 TTFields 與每週一次紫杉醇治療鉑類耐藥卵巢癌。今年晚些時候，INNOVATE-3 頂行之後將展示完整的 INNOVATE-3 數據。

In the first quarter of 2024, we expect to release the top line results from the Phase III METIS trial treating brain metastases from non-small cell lung cancer. And as we announced last week, the Phase III PANOVA-3 trial treating locally advanced pancreatic cancer has successfully cleared its interim analysis with no safety or futility concerns and will continue to follow patients to completion. We anticipate top line results from PANOVA-3 in the second half of 2024. Each of these trials is designed to evaluate TTFields therapy in cancers with substantial unmet needs. We look forward to sharing the results on these trials in the coming quarters.

2024 年第一季度，我們預計將發布治療非小細胞肺癌腦轉移的 III 期 METIS 試驗的主要結果。正如我們上周宣布的，治療局部晚期胰腺癌的 III 期 PANOVA-3 試驗已成功通過其中期分析，不存在安全性或無效性問題，並將繼續跟踪患者直至完成。我們預計 PANOVA-3 的主要結果將在 2024 年下半年得到。這些試驗均旨在評估 TTFields 治療癌症的治療，而這些癌症的需求尚未得到滿足。我們期待在未來幾個季度分享這些試驗的結果。

As we design and launch our next wave of clinical trials, it has never been more important for our commercial business to execute on its potential. Our GBM business provides the financial strength to invest aggressively in our continued research and development efforts. This quarter was another period of solid execution across our key global markets as we continue to see the fruits of our commercial efforts and 2022 organizational restructuring.

當我們設計和啟動下一波臨床試驗時，對於我們的商業業務來說，發揮其潛力從未如此重要。我們的 GBM 業務提供了財務實力，可以積極投資於我們持續的研發工作。本季度是我們在全球主要市場的又一個紮實執行的時期，我們繼續看到我們的商業努力和 2022 年組織重組的成果。

Increasing penetration in our leading markets is crucial to our long-term success. For the second quarter in a row, we achieved a record number of new prescriptions with 1,556 globally. We also saw another strong quarter in the U.S. with 981 prescriptions written in the period. U.S. prescriptions are now up 8% year-to-date compared to the first half of 2022.

提高對我們主要市場的滲透率對於我們的長期成功至關重要。我們連續第二個季度在全球範圍內獲得了創紀錄的新處方數量，達到 1,556 個。我們還看到美國的另一個強勁季度，期內開出了 981 份處方。與 2022 年上半年相比，美國處方藥今年迄今增加了 8%。

We also delivered a strong quarter in EMEA with a record of 483 new prescriptions in Q2. One of the key drivers to this quarter's strength was our successful launch of Optune in France. As a reminder, in March of this year, we received national reimbursement in France and began our commercial launch. We continue to ramp activities in France and we are very encouraged by the strong physician interest in TTFields therapy. We believe the launch in France can serve as a blueprint for other major EMEA markets.

我們在歐洲、中東和非洲地區的季度業績也表現強勁，第二季度新增處方數達到 483 個，創歷史新高。本季度業績強勁的關鍵推動力之一是我們在法國成功推出 Optune。提醒一下，今年 3 月，我們在法國收到了國家報銷並開始了商業發布。我們繼續加大在法國的活動力度，醫生對 TTFields 療法的濃厚興趣讓我們深受鼓舞。我們相信在法國的推出可以作為其他主要歐洲、中東和非洲市場的藍圖。

We also had a strong quarter in Germany with 499 active patients on therapy in Germany. It's rewarding to see the German active patient count on track and recovering as expected. In addition to our efforts to increase penetration and enter new markets, the rollout of our next-generation arrays continues in earnest. Patients in Austria and Sweden have been using the new arrays for several months now and feedback continues to be positive.

我們在德國的季度表現也很強勁，有 499 名活躍患者在德國接受治療。看到這位德國活躍患者步入正軌並按預期康復是令人欣慰的。除了努力提高滲透率和進入新市場外，我們還在認真推出下一代陣列。奧地利和瑞典的患者已經使用新陣列幾個月了，反饋仍然積極。

Consistent with last quarter, patients have experienced fewer alarms and the new arrays provide a more comfortable therapy experience. The positive data we have collected are informing next steps for the new arrays. We are on track to release the new arrays in Germany in coming months, the first of our large anchor markets.

與上季度一致，患者收到的警報減少了，新陣列提供了更舒適的治療體驗。我們收集到的積極數據正在為新陣列的後續步驟提供信息。我們有望在未來幾個月內在德國發布新陣列，這是我們的第一個大型錨定市場。

In the U.S., we are on track to file a PMA supplement in the second half of this year. Our new arrays have the potential to meaningfully improve the TTFields therapy experience, and we are eager to get them to all of our patients globally as soon as possible.

在美國，我們有望在今年下半年提交 PMA 補充文件。我們的新陣列有潛力顯著改善 TTFields 治療體驗，我們渴望盡快將其帶給全球所有患者。

Before we turn to the second quarter financial results, I would like to thank my Novocure colleagues. I know this has been an exciting and challenging quarter on many fronts, but I would like to applaud your dedication to our mission and most importantly, our patients.

在我們討論第二季度財務業績之前，我要感謝我的 Novocure 同事。我知道這在許多方面都是一個令人興奮且充滿挑戰的季度，但我要讚揚您對我們使命的奉獻，最重要的是對我們患者的奉獻。

With that, I will turn to Ashley to discuss our financial performance in the quarter.

接下來，我將請阿什利討論我們本季度的財務業績。

Thank you, Asaf. Many of the themes from the first quarter have remained consistent through June. We continue to see early positive indications of growth in our GBM business, our clinical trials are progressing, our pipeline is expanding, and we are working to solidify our infrastructure ahead of multiple potential future launches in new indications. We generated $126 million in net revenues in the quarter and ended the period with 3,571 active patients on therapy. Q2 continued the positive momentum we saw in the first quarter of the year with another quarter of year-over-year prescription growth. We did face two notable net revenue headwinds in the quarter in the U.S. compared to Q2 of 2022 as last year, we benefited from $13 million in collections from previously denied or appealed claims as well as a $6 million catch-up benefit due to variations in approval rates.

謝謝你，阿薩夫。第一季度的許多主題在整個六月份都保持一致。我們繼續看到 GBM 業務增長的早期積極跡象，我們的臨床試驗正在取得進展，我們的產品線正在擴大，並且我們正在努力鞏固我們的基礎設施，以應對未來多個潛在的新適應症的推出。本季度我們實現了 1.26 億美元的淨收入，截至本季度末，有 3,571 名活躍患者正在接受治療。第二季度延續了今年第一季度的積極勢頭，處方藥數量又實現同比增長。與去年的2022 年第二季度相比，我們在美國的本季度確實面臨著兩個明顯的淨收入逆風，我們從之前被拒絕或上訴的索賠中獲得了1300 萬美元的收款，以及由於變化而獲得的600 萬美元的追趕收益。批准率。

In Germany, we continue to see the expected recovery in active patients and reimbursement rates. We ended the quarter with 499 active patients on therapy, a high watermark since payer negotiations were finalized last year, and we expect this recovery to continue through year-end. The second quarter did include a catch-up revenue benefit of $5 million in Germany due to variations of approval rates as more patients are meeting coverage criteria in the market.

在德國，我們繼續看到活躍患者的預期康復和報銷率。截至本季度末，我們有 499 名活躍患者正在接受治療，這是自去年完成付款人談判以來的最高水平，我們預計這種複蘇將持續到年底。由於越來越多的患者滿足市場上的承保標準，批准率發生變化，第二季度在德國確實帶來了 500 萬美元的追趕性收入收益。

As mentioned earlier, we are off to a strong start in France. We are very encouraged by the launch, especially the prescription flow from Paris. We believe the investments made in prelaunched commercial infrastructure, including market access and pre-commercial physician and patient engagement functions provide a strong blueprint for future launches in new markets.

如前所述，我們在法國有了一個良好的開端。我們對這一產品的推出感到非常鼓舞，尤其是來自巴黎的處方流。我們相信，對預啟動的商業基礎設施的投資，包括市場准入和預商業醫生和患者參與功能，為未來在新市場的啟動提供了強有力的藍圖。

Given the reimbursement process and collection cycle timing, we expect France to contribute to revenue beginning in the second half of this year. As a reminder, it will take several quarters for the collection cycle in France to reach full reimbursement rates, which will impact our net revenue per active patient per month in EMEA during the transition.

考慮到報銷流程和收款週期時間，我們預計法國將從今年下半年開始貢獻收入。提醒一下，法國的收款週期需要幾個季度才能達到全額報銷率，這將影響我們在過渡期間在歐洲、中東和非洲地區每名活躍患者每月的淨收入。

Gross margin for the second quarter was 73%. Our cost of revenues increased $4 million due to incremental spending to expand patient support capacity in preparation of treating larger patient populations in new geographies and new indications in the near future. While we expect gross margins to be impacted by product enhancements in the near term, such as the ongoing launch of the new arrays, we remain focused on opportunities to increase efficiencies and scale within our supply chain and expect cost optimization over time.

第二季度毛利率為73%。我們的收入成本增加了 400 萬美元，原因是增加了支出以擴大患者支持能力，為不久的將來在新地區和新適應症中治療更多患者群體做好準備。雖然我們預計毛利率將在短期內受到產品增強的影響，例如新陣列的持續推出，但我們仍然關注提高供應鏈效率和規模的機會，並期望隨著時間的推移實現成本優化。

SG&A expenses for the second quarter were $99 million. As we look ahead to the potential opportunity to reach patients in multiple new indications as well as new markets, we are focused on solidifying key functions to ensure we can meet the opportunity presented. This includes expanding our sales and marketing efforts as well as increased spending in our IT and supply chain teams. While there will be growth in the aforementioned areas, you should not expect to see a material step function increase until we are closer to a commercial launch in non-small cell lung cancer.

第二季度的 SG&A 支出為 9900 萬美元。當我們展望接觸多個新適應症和新市場患者的潛在機會時，我們專注於鞏固關鍵職能，以確保我們能夠抓住所出現的機會。這包括擴大我們的銷售和營銷力度，以及增加 IT 和供應鏈團隊的支出。雖然上述領域將會有所增長，但在我們接近非小細胞肺癌的商業推出之前，您不應期望看到實質性的階躍功能增加。

Research and development costs for the quarter were $55 million. As we have previously shared, as the current Phase III clinical trials conclude, we will backfill our clinical pipeline with new Phase II and Phase III trials in the coming quarter. The first of these new trials is the LUNAR-2 trial, for which we recently received investigational device exemption approval from the U.S. FDA. We expect moderate growth in R&D costs as more Phase II and Phase III trial launch and as we continue to invest in product development. With multiple trials in various stages of design and regulatory approval, we look forward to updating you on new clinical development later this year.

該季度的研發成本為 5500 萬美元。正如我們之前所分享的，隨著當前 III 期臨床試驗的結束，我們將在下個季度通過新的 II 期和 III 期試驗來補充我們的臨床管道。這些新試驗中的第一個是 LUNAR-2 試驗，我們最近獲得了美國 FDA 的研究設備豁免批准。我們預計，隨著更多二期和三期試驗的啟動以及我們繼續投資於產品開發，研發成本將適度增長。通過處於設計和監管審批各個階段的多項試驗，我們期待在今年晚些時候向您通報新臨床開發的最新情況。

Cash and short-term investments totaled $941 million as of June 30, 2023. Our net loss for the first quarter (sic) [second quarter] was $0.54 per share or $57 million and adjusted EBITDA was negative $27 million. We are in a period of transformation and preparation as we eye the opportunity to treat patients in indications that are multiple times the size of GBM. We are investing strategically to ensure we are optimizing our launch potential to meet upcoming opportunities. All of these investments are supported by our sustainable and strengthening commercial business in GBM. I'd like to close today by highlighting one of our very first Optune users in Canada, [Joel Bering]. [Joel] has been writing and performing with the acoustic guitar in Quebec for more than 40 years. Last year, Joel began having trouble remembering songs and started to lose sensitivity in his fingers. Following an MRI, Joel is diagnosed with glioblastoma. After a successful surgery, [Joel's] radiation oncologist told him about Optune, which Health Canada had just recently approved weeks earlier.

截至2023 年6 月30 日，現金和短期投資總額為9.41 億美元。我們第一季度（原文如此）[第二季度]的淨虧損為每股0.54 美元，即5700 萬美元，調整後的EBITDA 為負2700 萬美元。我們正處於轉型和準備階段，因為我們正在尋找機會治療數倍於 GBM 的患者。我們正在進行戰略投資，以確保優化我們的發布潛力，以滿足即將到來的機遇。所有這些投資都得到了我們在 GBM 的可持續和不斷增強的商業業務的支持。在今天結束時，我想強調一下我們在加拿大的首批 Optune 用戶之一，[Joel Bering]。 [Joel] 在魁北克從事原聲吉他創作和表演已有 40 多年。去年，喬爾開始難以記住歌曲，手指也開始失去敏感性。經過核磁共振檢查後，喬爾被診斷出患有膠質母細胞瘤。手術成功後，[Joel 的]放射腫瘤科醫生向他介紹了 Optune，加拿大衛生部在幾週前剛剛批准了 Optune。

In November, he began using Optune. Within weeks of receiving treatment, Joel was back playing the guitar. People like Joel are a constant reminder of why we are here, to extend survival in some of the most aggressive forms of cancer and to give patients like Joel the opportunity to continue doing what they love.

11 月，他開始使用 Optune。接受治療後幾週內，喬爾就恢復彈吉他了。像喬爾這樣的人不斷提醒我們為什麼在這裡，為了延長一些最具侵襲性的癌症的生存時間，並為像喬爾這樣的患者提供繼續做他們喜歡的事情的機會。

With that, I will turn it back to the operator for questions.

這樣，我會將其轉回給接線員詢問問題。

(Operator Instructions) And our first question comes from Jason Bednar of Piper Sandler.

（操作員說明）我們的第一個問題來自 Piper Sandler 的 Jason Bednar。

I wanted to start with maybe a multiparter on LUNAR-2, a really large study, longer patient follow-up than we've seen from Novocure in the past with your other Phase III trials. Can you talk about how you're thinking about maybe the pace of enrollment, number of recruiting sites here? And I don't mean to be in sensitive at all, but one of the challenges that we ran into with LUNAR was just that it was a competitive market for lung cancer trials, never reached the original enrollment targeted even after several years. So why is LUNAR-2 different?

我想從 LUNAR-2 的多方合作開始，這是一項非常大型的研究，比我們過去在 Novocure 的其他 III 期試驗中看到的患者隨訪時間更長。您能談談您對招生速度、招聘網站數量的看法嗎？我並不是要敏感，但我們在 LUNAR 上遇到的挑戰之一是，這是一個肺癌試驗的競爭市場，即使在幾年後也從未達到最初的入組目標。那麼為什麼LUNAR-2有所不同呢？

And then as a follow-up there, can you address whether there's an interim analysis at any point in the study during or after enrollment? And then again, sorry, for the multiparter, but is this using your new high-intensity arrays in the study?

然後，作為後續行動，您能否解決在研究期間或之後的任何時間點是否有中期分析？再說一次，抱歉，對於多人來說，這是在研究中使用你們新的高強度陣列嗎？

Great, Jason. Thank you for that question. This is Pritesh. I'd like to remind everybody about the LUNAR-2 study. So this is our next randomized global study that will explore Tumor Treating Fields concomitantly with pembrolizumab in the first-line setting, first-line metastatic non-small cell lung cancer setting. And this is an important study because we have now shown that Tumor Treating Fields work along with an immune checkpoint inhibitor in the second-line setting. So as typical development would go, we would look to bring the therapy earlier in the treatment algorithm to be able to have a broader impact on patients.

太棒了，傑森。謝謝你提出這個問題。這是普里泰什。我想提醒大家有關 LUNAR-2 研究的信息。因此，這是我們的下一項隨機全球研究，將探索在一線治療、一線轉移性非小細胞肺癌治療中與派姆單抗聯合使用的腫瘤治療領域。這是一項重要的研究，因為我們現在已經證明腫瘤治療電場與免疫檢查點抑製劑在二線治療中協同作用。因此，隨著典型的開發進展，我們希望將治療納入治療算法的早期，以便能夠對患者產生更廣泛的影響。

And as you heard in the prepared remarks, this study is designed to enroll 734 patients over 21-month follow-up period. And one of the things that we learn in the lung cancer setting today is that the most commonly used immune checkpoint inhibitor is pembrolizumab. That is the standard of care today. And we're looking to add on to that standard of care to extend survival and help these patients. So we will help you understand as the trial opens up. We're looking at sites right now in the hopes to get our first site up and running enrolling the first patient. And we will keep you updated on how the study progresses thereon forward.

正如您在準備好的發言中所聽到的，這項研究旨在在 21 個月的隨訪期內招募 734 名患者。我們今天在肺癌治療中了解到的一件事是，最常用的免疫檢查點抑製劑是派姆單抗。這就是今天的護理標準。我們希望提高護理標準，以延長患者的生存期並幫助這些患者。因此，隨著審判的開始，我們將幫助您理解。我們現在正在尋找站點，希望能夠建立並運行我們的第一個站點來招募第一個患者。我們將隨時向您通報該研究的進展情況。

Okay. Sorry, just to maybe on some of those -- I mean, can you say whether there is an interim analysis at any point in the study? And also whether it's using your new high-intensity arrays.

好的。抱歉，也許只是針對其中一些——我的意思是，你能說一下研究中的任何時候是否有中期分析嗎？還有是否使用新的高強度陣列。

Yes. Thank you for reminding me about that. So on the interim analysis front, there's not an interim analysis plan. And on the new arrays, I'll remind you that the new arrays today are for patients with GBM and we're working on other array innovation for the torso and abdomen patients.

是的。謝謝你提醒我這一點。因此，在中期分析方面，沒有中期分析計劃。關於新陣列，我要提醒您，今天的新陣列適用於 GBM 患者，我們正在致力於針對軀乾和腹部患者的其他陣列創新。

Okay. All right. Understood. And then maybe Ashley, I'm trying to reconcile, if I could, the gross margin in the quarter. It was below our model. And I guess, I think you mentioned maybe the new arrays that you have might be lower margin than the older generation. I guess did I hear that right? And then are there other factors that may be influencing gross margin like you're treating patients in France or Canada or other markets but you're not yet getting paid yet for those patients?

好的。好的。明白了。然後，也許阿什利，如果可以的話，我正在努力調節本季度的毛利率。它低於我們的模型。我想，我想你提到過，你擁有的新陣列的利潤率可能比老一代要低。我想我沒聽錯吧？還有其他因素可能會影響毛利率，例如您正在法國、加拿大或其他市場治療患者，但您尚未為這些患者獲得報酬？

Yes, Jason, thank you for the question. The short answer is yes to everything that you ran down. But if we look at this a little bit more in detail, our gross margin is now steady. I would say and at a stable rate, if you look at the actual cost per COGS per active patient, if you look at what most impacted the margin year-over-year, you have to look at the net revenue. So as we took the benefit of the aged claims out of the top line, you saw that flow through to the margin number.

是的，傑森，謝謝你的提問。對於你所遇到的一切，簡短的回答都是肯定的。但如果我們更詳細地看待這一點，我們的毛利率現在是穩定的。我想說的是，在穩定的情況下，如果你看看每個活躍患者的每銷貨成本的實際成本，如果你看看什麼對利潤率同比影響最大，你就必須看看淨收入。因此，當我們將老化索賠的收益從頂線中扣除時，您會看到它流向了保證金數字。

And then additionally, you saw the impact of some increased investments in patient support that we made at the beginning of this year to ensure we were ready for new geographies and for potential future indications. So I would expect that, that investment has now stabilized. We're at where we need to be, but it did affect margins both in the quarter and year-over-year.

此外，您還看到了我們在今年年初增加的患者支持投資的影響，以確保我們為新的地區和未來潛在的適應症做好準備。所以我預計投資現在已經穩定下來。我們已經達到了我們需要達到的目標，但這確實影響了本季度和同比的利潤率。

As we look ahead, we are signaling that we may have some slight downward pressure on margin as we introduce the new arrays. As with any new product enhancement, there's a period of kind of manufacturing efficiencies and scale. It takes a little bit of time to get there, and we are committed to getting these arrays rolled out as quickly as possible, why we optimize the supply chain. But I would say that is just slight pressure, and we will certainly be working to optimize that over time.

展望未來，我們發出信號，隨著我們推出新陣列，我們的利潤率可能會面臨一些輕微的下行壓力。與任何新產品的改進一樣，都有一個製造效率和規模提升的時期。實現這一目標需要一點時間，我們致力於盡快推出這些陣列，這也是我們優化供應鏈的原因。但我想說這只是輕微的壓力，隨著時間的推移，我們肯定會努力優化它。

Okay. And those patients support investments. You mentioned those hit gross margin, they don't fall into SG&A.

好的。這些患者支持投資。你提到那些影響毛利率的產品，它們不屬於SG&A。

They do. Much of our patient support flows into our COGS line.

他們是這樣。我們的大部分患者支持都流入了我們的 COGS 系列。

And our next question comes from Emily Bodnar of H.C. Wainwright.

我們的下一個問題來自 H.C. 的 Emily Bodnar。溫賴特。

I'm curious on the LUNAR -- the new LUNAR study that you're planning to evaluate in the second-line setting with TTFields, with checkpoint inhibitors post-chemo IO. Do you see any risk with the FDA potentially wanting to wait to see results from that study prior to approval in that setting? And can you also discuss any time lines for the other LUNAR studies that you're planning to initiate and design plans for those?

我對 LUNAR 很好奇，這是一項新的 LUNAR 研究，您計劃在二線環境中使用 TTFields 進行評估，並在化療後 IO 後使用檢查點抑製劑。您認為 FDA 在批准該研究之前等待該研究的結果是否存在任何風險？您能否討論一下您計劃啟動的其他月球研究的時間表並為其設計計劃？

Yes. So this is Bill. Thanks for the question. I'll start with the regulatory question, and then I'll turn it back to Pritesh to talk about the other trials. But the simple answer is no. We don't expect any issues like the issue you described with the FDA. Again, LUNAR hit its primary endpoint. It was a large randomized trial. We've stated that the cohorts were all well balanced, and we hit the ITT and we will be seeking a label that is consistent with that primary endpoint. And so we don't expect any requirement for waiting for additional trials as you described.

是的。這就是比爾。謝謝你的提問。我將從監管問題開始，然後我會將其轉回 Pritesh 來討論其他試驗。但簡單的答案是否定的。我們預計不會出現任何像您向 FDA 描述的問題那樣的問題。 LUNAR 再次達到了其主要終點。這是一項大型隨機試驗。我們已經說過，這些隊列都很平衡，我們達到了 ITT，我們將尋找一個與主要終點一致的標籤。因此，我們預計不需要等待您所描述的額外試驗。

Yes. Thank you, Bill. And what I would close with, with regards to the next set of trials is that this is a really important opportunity for us to expand on the label that we expect to get with LUNAR and continuing to build the evidence in non-small cell lung cancer setting. So with that, we already talked about LUNAR-2, which is, again, a first-line metastatic non-small cell lung cancer trial, exploring Tumor Treating Fields with pembrolizumab.

是的。謝謝你，比爾。關於下一組試驗，我最後要說的是，這對我們來說是一個非常重要的機會，可以擴展我們期望通過 LUNAR 獲得的標籤，並繼續建立非小細胞肺癌的證據環境。因此，我們已經討論了 LUNAR-2，這又是一項一線轉移性非小細胞肺癌試驗，探索用派姆單抗治療腫瘤的領域。

The second study we're looking to initiate is a Tumor Treating Fields with immune checkpoint inhibitor following chemo radiation in the first-line locally advanced metastatic non-small cell lung cancer setting. Again, our strategy here is to ensure that the data that we see with Tumor Treating Fields and IO in the second-line setting to move the therapy in the earlier settings so that we can have an even bigger benefit for patients and really impact those patients with non-small cell lung cancer.

我們希望啟動的第二項研究是在一線局部晚期轉移性非小細胞肺癌化療放療後使用免疫檢查點抑製劑進行腫瘤治療。同樣，我們的策略是確保我們在二線設置中看到的腫瘤治療場和 IO 的數據能夠將治療轉移到早期設置中，以便我們能夠為患者帶來更大的益處並真正影響這些患者患有非小細胞肺癌。

And I'll just add, this is consistent with the way progress is typically made in these cancers. I would remind everyone that this is where pembro started in the distant lines and then, over time, conducted additional studies and moved to the earlier lines. So we're following the same strategic pathway that is typical in the industry.

我想補充一點，這與這些癌症通常取得進展的方式是一致的。我想提醒大家，這是彭布羅在遙遠的線路中開始的地方，然後隨著時間的推移，進行了額外的研究並轉移到了較早的線路。因此，我們正在遵循行業中典型的相同戰略路徑。

Right. I just want to confirm, are these all planned to initiate this year?

正確的。我想確認一下，這些都是計劃今年啟動的嗎？

Yes. So I would say as soon as possible because we're looking forward to get these trials up and running and enrolling patients and getting to the data readouts.

是的。所以我想說盡快，因為我們期待著這些試驗的啟動和運行，招募患者並獲得數據讀數。

Yes. There's always a regulatory step here, and we're always hesitant to predict when the FDA will provide the IDE. We were very pleased in this quarter to announce the IDE for LUNAR-2. So that's a very important step for us that may not have been emphasized.

是的。這裡總是有一個監管步驟，我們總是對預測 FDA 何時提供 IDE 猶豫不決。我們非常高興在本季度推出 LUNAR-2 的 IDE。所以這對我們來說是非常重要的一步，但可能沒有被強調。

And our next question comes from Vijay Kumar of Evercore ISI.

我們的下一個問題來自 Evercore ISI 的 Vijay Kumar。

This is Kevin on for Vijay. Just one on prescriptions in active patients on treatment in other markets. Can you talk to the performance this quarter? Was France a key driver? Or did the reclassification of Canada into other markets have anything to do with the performance this quarter? Any factors you can call out would be helpful.

這是維杰的凱文。只有一份針對在其他市場接受治療的活躍患者的處方。您能談談本季度的業績嗎？法國是關鍵驅動力嗎？或者加拿大重新分類到其他市場與本季度的表現有什麼關係嗎？您可以提出的任何因素都會有所幫助。

Kevin, this is Ashley, and I can take that question. So as noted, we were pleased with kind of the continued positive momentum that we saw in GBM. It was a solid quarter, I would say, around the globe with maintained momentum in the U.S., a steady recovery in Germany. And then as you noted, a very strong launch in France. France was a key driver of the growth in our international markets. You can see in our 10-Q, which we did publish this morning, the breakout of those prescriptions by region, but we did see a significant early strong physician interest in Tumor Treating Fields in France. It is not yet contributing to revenue.

凱文，我是阿什利，我可以回答這個問題。如前所述，我們對 GBM 持續的積極勢頭感到高興。我想說，這是一個穩健的季度，全球範圍內，美國保持了增長勢頭，德國穩步復甦。然後正如您所指出的，在法國的推出非常強勁。法國是我們國際市場增長的主要推動力。您可以在我們今天早上發布的 10-Q 中看到這些處方按地區的細分，但我們確實看到法國醫生早期對腫瘤治療領域表現出濃厚的興趣。它尚未對收入做出貢獻。

I will note that we would expect France to begin to contribute to revenue in the second half of this year, given the time line to reimbursement and collection cycle. I think that answered your question because you asked about the other markets, but I would like to highlight again the maintained momentum in the U.S. The U.S. is our largest and our most important market. And again, I would say we were very pleased to be able to see the continued strength from the back of our transition to our franchise model last year there.

我要指出的是，考慮到報銷和收款週期的時間安排，我們預計法國將在今年下半年開始貢獻收入。我認為這回答了你的問題，因為你問了其他市場，但我想再次強調美國保持的勢頭。美國是我們最大也是最重要的市場。我想說，我們很高興能夠看到去年我們向特許經營模式轉型後的持續實力。

And have you sized Canada at all from an active patients or prescriptions perspective?

您是否從活躍患者或處方的角度來衡量加拿大的規模？

Yes. So of course, as we make those investments, we're doing all the associate analysis on the market. But I would say that is not a material driver of what you're seeing yet because we are still pending reimbursement in Canada.

是的。當然，當我們進行這些投資時，我們正在對市場進行所有相關分析。但我想說，這並不是您所看到的情況的實質性驅動因素，因為我們仍在加拿大等待報銷。

Thank you. I would now like to turn the conference back to Bill Doyle for closing remarks.

謝謝。現在我想請比爾·多伊爾（Bill Doyle）致閉幕詞。

So thank you, everyone, on the phone for your continued interest and support in Novocure. We have entered a period of transformation and expansion that kicked off earlier this year with the presentation of the successful LUNAR Phase III trial data. Over the next 18 months, we will have data readouts from 3 more Phase III trials, making a total of 6 Phase III trials for which we will have data readouts, all in difficult-to-treat cancers with great unmet need. The possibility of treating thousands of additional patients is becoming a reality, and we look forward to updating you on our progress throughout the year. Thanks again.

感謝大家在電話中對 Novocure 的持續關注和支持。我們已經進入了一個轉型和擴張的時期，從今年早些時候成功推出 LUNAR III 期試驗數據開始。在接下來的 18 個月內，我們將獲得另外 3 項 III 期試驗的數據讀數，這樣我們將獲得總共 6 項 III 期試驗的數據，這些試驗全部針對具有巨大未滿足需求的難以治療的癌症。治療數千名額外患者的可能性正在成為現實，我們期待向您通報我們全年的進展情況。再次感謝。

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

今天的電話會議到此結束。感謝您的參與，您現在可以斷開連接。