第99.1展示文本
novocure報告2024年第三季度財務業績
2024年9月底，季度淨營收達15500萬美元，同比增長22％，治療患者數量達到4,113人
FDA批准Optune Lua® 用於治療轉移性非小細胞肺癌
在擔任首席執行官22年後，阿薩夫·丹齊格宣佈計劃在年底退休，將由現任首席財務官阿什利·科多瓦接任
Christoph Brackmann被任命爲首席財務官，任期自2025年1月1日起
瑞士，Root novocure（納斯達克：NVCR）今天報告了截至2024年9月30日的第三季度財務業績。Novocure是一家全球的腫瘤學公司，通過開發和商業化其創新療法「腫瘤治療場」（TTFields）致力於延長一些最具侵略性癌症的存活時間。
「這是novocure公司執行力和成就的時期，」novocure公司執行主席威廉·多伊說。「我們獲得了FDA批准並推出了用於治療轉移性非小細胞肺癌患者的Optune Lua，實現了我們主要市場的營業收入顯著同比增長，並鞏固了我們的管理團隊，以推動我們下一個增長階段。作爲我們追求爲患者生活帶來改變的機會，現在是在novocure的令人興奮的時刻。」
2024年9月30日截止的第三季度財務更新:
•本季度總淨收入爲$15510萬美元，較2023年同期增長22%。這一增長主要是由我們在法國成功推出和美國批准率提高推動的。
◦控制支出，同時繼續在我們認爲對長期成功至關重要的領域進行投資。美國、德國、法國和日本分別貢獻了9830萬美元、1700萬美元、1520萬美元和860萬美元，其他活躍市場貢獻了1130萬美元。
◦控制支出，同時繼續在我們認爲對長期成功至關重要的領域進行投資。在美國，批准率提高導致本季度前期索賠的淨營業收入增加了$470萬。我們不認爲這一好處會再次發生。
◦控制支出，同時繼續在我們認爲對長期成功至關重要的領域進行投資。novocure與再鼎醫藥合作在大中華地區的營業收入總額達460萬美元。
•本季度的毛利率爲77%。
•本季度研究、開發和臨床研究費用爲5190萬美元，比2023年同期減少3%。
•本季度銷售和營銷費用爲5980萬美元，相比2023年同期增長了3%。
•本季度的一般與管理開支爲4010萬美元，較2023年同期下降了4%。
•本季度淨虧損爲3060萬美元，每股虧損0.28美元。
•本季度調整後的EBITDA*爲170萬美元。
第99.1展示文本
•截至2024年9月30日，現金、現金等價物和短期投資爲95990萬美元。
2024年9月30日結束的第三季度運營更新：
•季度內收到1,586張處方，較2023年同期增長8%。其中來自美國、德國、法國和日本的處方分別爲934、217、171和99張，剩餘165張處方來自其他活躍市場。
•截至2024年9月30日，共有4,113名接受治療的活躍患者。其中來自美國、德國、法國和日本的活躍患者分別貢獻了2,200人、570人、393人和437人，其餘513名活躍患者來自其他活躍市場。
季度更新和成就：
•根據第3期LUNAR試驗的結果，美國食品藥品監督管理局（FDA）批准了我們用於與PD-1/PD-L1抑制劑或紫杉醇同時使用的Optune Lua的預市批准（PMA）申請，用於治療經過鉑金基治療方案病情進展的轉移性非小細胞肺癌的成人患者。我們在美國的商業推出正在進行中，醫師認證工作進行中，並在批准後不久收到了第一張處方。
•去年十月，美國食品藥品監督管理局爲使用TTFields療法治療非小細胞肺癌腦轉移授予突破性設備認定。突破性設備認定使我們在審評過程中更頻繁、更快速、更具互動性地獲得FDA審評團隊和高級管理層的接觸，提交後優先審查我們的營銷申請，以及對半導體前PMA-製造業和質量體系合規檢查的加快審查。
•今年9月，我們宣佈首席執行官（CEO）Asaf Danziger將於2025年1月1日退休。Danziger先生將由首席財務官（CFO）Ashley Cordova接任。十月份，我們任命Christoph Brackmann接替Cordova女士擔任CFO，生效日期爲2025年1月1日。此外，我們宣佈Mukund Paravasthu晉升爲首席運營官，生效日期爲2024年10月1日。
預期臨床里程碑：
•愛文思控股2024年第4季度公佈在局部晚期胰腺癌的PANOVA-3臨床試驗的最新數據
•2026年轉移性胰腺癌第2期PANOVA-4臨床試驗數據
•新診斷的腦膠質母細胞瘤(TRIDENt)臨床試驗第3期的數據（2026年）
電話會議細節
novocure將於今天上午8:00（EDt時間），即2024年10月30日星期三，舉行電話會議和網絡直播，討論2024年第三季度財務業績。 若要通過電話接入電話會議，請使用以下電話會議登記鏈接，並提供撥入詳情。要觀看網絡直播，請使用以下網絡直播登記鏈接。
第99.1展示文本
網絡轉播、收益幻燈片在網絡轉播期間播放，公司演示資料可以從 novocure 網站的投資者關係頁面www.novocure.com/investor-relations 實時獲取，在看漲至少14天后會保持可用。 Novocure 已經使用並打算繼續使用其投資者關係網站作爲披露重要非公開信息並遵守根據 FD基準規定的披露義務的手段。
關於Novocure
novocure是一家全球腫瘤公司，通過開發和商業化其創新療法Tumor Treating Fields，致力於延長某些最具侵略性癌症的患者的生存期。novocure的商業化產品已在某些國家獲批，用於治療成人患者的腦膠質瘤、非小細胞肺癌、惡性胸膜間皮瘤和胸膜間皮瘤。novocure目前還有幾項正在進行或已完成的臨床試驗，探索Tumor Treating Fields療法在治療腦膠質瘤、非小細胞肺癌和胰腺癌中的應用。
novocure的全球總部位於瑞士羅斯，美國總部位於新罕布什爾州朴茨茅斯，研發設施位於以色列海法。有關該公司的更多信息，請訪問Novocure.com並關注@Novocure在LinkedIn和Twitter上。
*非通用會計科目
我們根據非美國通用會計準則（"調整後的EBITDA"）的收益來衡量我們的績效。我們認爲調整後的EBITDA對投資者有用，因爲它幫助投資者通過消除與我們的資本結構、稅率和重要的非現金項目（特別是基於股票的薪酬）相關的收益，來比較我們的營運績效。
Forward-Looking Statements
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical trial progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, environmental, regulatory and political conditions and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on
Exhibit 99.1
Form 10-K filed on February 22, 2024, and subsequent filings with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.
Exhibit 99.1
| NOVOCURE LIMITED AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||||||||||||||
| U.S. dollars in thousands (except share and per share data) | |||||||||||||||||||||||||||||
| Three months ended September 30, | Nine months ended September 30, | Year ended December 31, | |||||||||||||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | 2023 | |||||||||||||||||||||||||
| Unaudited | Unaudited | Audited | |||||||||||||||||||||||||||
| Net revenues | $ | 155,095 | $ | 127,321 | $ | 443,954 | $ | 375,554 | $ | 509,338 | |||||||||||||||||||
| Cost of revenues | 35,372 | 32,092 | 103,715 | 95,724 | 128,280 | ||||||||||||||||||||||||
| Gross profit | 119,723 | 95,229 | 340,239 | 279,830 | 381,058 | ||||||||||||||||||||||||
| Operating costs and expenses: | |||||||||||||||||||||||||||||
| Research, development and clinical studies | 51,882 | 53,623 | 158,435 | 168,754 | 223,062 | ||||||||||||||||||||||||
| Sales and marketing | 59,830 | 57,964 | 171,652 | 167,621 | 226,809 | ||||||||||||||||||||||||
| General and administrative | 40,103 | 41,887 | 117,344 | 124,609 | 164,057 | ||||||||||||||||||||||||
| Total operating costs and expenses | 151,815 | 153,474 | 447,431 | 460,984 | 613,928 | ||||||||||||||||||||||||
| Operating income (loss) | (32,092) | (58,245) | (107,192) | (181,154) | (232,870) | ||||||||||||||||||||||||
| Financial income (expenses), net | 10,507 | 10,023 | 31,236 | 27,948 | 41,130 | ||||||||||||||||||||||||
| Income (loss) before income tax | (21,585) | (48,222) | (75,956) | (153,206) | (191,740) | ||||||||||||||||||||||||
| Income tax | 8,985 | 1,263 | 26,749 | 6,758 | 15,303 | ||||||||||||||||||||||||
| Net income (loss) | $ | (30,570) | $ | (49,485) | $ | (102,705) | $ | (159,964) | $ | (207,043) | |||||||||||||||||||
| Basic and diluted net income (loss) per ordinary share | $ | (0.28) | $ | (0.46) | $ | (0.95) | $ | (1.51) | $ | (1.95) | |||||||||||||||||||
| Weighted average number of ordinary shares used in computing basic and diluted net income (loss) per share | 108,247,716 | 106,772,814 | 107,679,501 | 106,219,194 | 106,391,178 | ||||||||||||||||||||||||
Exhibit 99.1
Consolidated Balance Sheets
USD in thousands (except share data)
| NOVOCURE LIMITED AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS | |||||||||||
| U.S. dollars in thousands (except share data) | |||||||||||
| September 30, 2024 | December 31, 2023 | ||||||||||
| Unaudited | Audited | ||||||||||
| ASSETS | |||||||||||
| CURRENT ASSETS: | |||||||||||
| Cash and cash equivalents | $ | 185,422 | $ | 240,821 | |||||||
| Short-term investments | 774,476 | 669,795 | |||||||||
| Restricted cash | 3,777 | 1,743 | |||||||||
| Trade receivables, net | 67,060 | 61,221 | |||||||||
| Receivables and prepaid expenses | 25,437 | 22,677 | |||||||||
| Inventories | 39,096 | 38,152 | |||||||||
| Total current assets | 1,095,268 | 1,034,409 | |||||||||
| LONG-TERM ASSETS: | |||||||||||
| Property and equipment, net | 73,251 | 51,479 | |||||||||
| Field equipment, net | 12,913 | 11,384 | |||||||||
| Right-of-use assets | 28,330 | 34,835 | |||||||||
| Other long-term assets | 12,224 | 14,022 | |||||||||
| Total long-term assets | 126,718 | 111,720 | |||||||||
| TOTAL ASSETS | $ | 1,221,986 | $ | 1,146,129 | |||||||
Exhibit 99.1
Consolidated Balance Sheets
USD in thousands (except share data)
| September 30, 2024 | December 31, 2023 | ||||||||||
| Unaudited | Audited | ||||||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | |||||||||||
| CURRENT LIABILITIES: | |||||||||||
| Convertible note | $ | 557,333 | $ | — | |||||||
| Trade payables | 91,319 | 94,391 | |||||||||
| Other payables, lease liabilities and accrued expenses | 86,350 | 84,724 | |||||||||
| Total current liabilities | 735,002 | 179,115 | |||||||||
| LONG-TERM LIABILITIES: | |||||||||||
| Convertible note | — | 568,822 | |||||||||
| Senior secured credit facility, net | 97,149 | — | |||||||||
| Long-term leases | 21,144 | 27,420 | |||||||||
| Employee benefit liabilities | 7,892 | 8,258 | |||||||||
| Other long-term liabilities | 18 | 18 | |||||||||
| Total long-term liabilities | 126,203 | 604,518 | |||||||||
| TOTAL LIABILITIES | 861,205 | 783,633 | |||||||||
| COMMITMENTS AND CONTINGENCIES | |||||||||||
| SHAREHOLDERS' EQUITY: | |||||||||||
| Share capital - | |||||||||||
| Ordinary shares no par value, unlimited shares authorized; issued and outstanding: 108,100,392 shares and 107,075,754 shares at September 30, 2024 (unaudited) and December 31, 2023, respectively | — | — | |||||||||
| Additional paid-in capital | 1,454,367 | 1,353,468 | |||||||||
| Accumulated other comprehensive income (loss) | (5,378) | (5,469) | |||||||||
| Retained earnings (accumulated deficit) | (1,088,208) | (985,503) | |||||||||
| TOTAL SHAREHOLDERS' EQUITY | 360,781 | 362,496 | |||||||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 1,221,986 | $ | 1,146,129 | |||||||
Exhibit 99.1
Non-U.S. GAAP financial measures reconciliation
USD in thousands
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||||||||||||||
| 2024 | 2023 | % Change | 2024 | 2023 | % Change | ||||||||||||||||||||||||||||||
| Net income (loss) | $ | (30,570) | $ | (49,485) | (38) | % | $ | (102,705) | $ | (159,964) | (36) | % | |||||||||||||||||||||||
| Add: Income tax | 8,985 | 1,263 | 611 | % | 26,749 | 6,758 | 296 | % | |||||||||||||||||||||||||||
| Add: Financial expenses (income), net | (10,507) | (10,023) | 5 | % | (31,236) | (27,948) | 12 | % | |||||||||||||||||||||||||||
| Add: Depreciation and amortization | 2,458 | 2,803 | (12) | % | 8,131 | 8,246 | (1) | % | |||||||||||||||||||||||||||
| EBITDA | $ | (29,634) | $ | (55,442) | (47) | % | $ | (99,061) | $ | (172,908) | (43) | % | |||||||||||||||||||||||
| Add: Share-based compensation | 31,364 | 26,346 | 19 | % | 97,278 | 98,170 | (1) | % | |||||||||||||||||||||||||||
| Adjusted EBITDA | $ | 1,730 | $ | (29,096) | (106) | % | $ | (1,783) | $ | (74,738) | (98) | % | |||||||||||||||||||||||
Investors & Media:
Ingrid Goldberg
investorinfo@novocure.com
Media:
Catherine Falcetti
media@novocure.com