Adaptimmune Reports Q3 2024 Financial and Business Updates
Adaptimmune Reports Q3 2024 Financial and Business Updates
Tecelra launch on track with 9 Authorized Treatment Centers available to initiate patient treatment journey, and the first patient apheresed in Q3; expect first commercial revenues in Q4 and the number of treated patients to accelerate throughout 2025
Tecelra的啓動步入正軌,有9個授權治療中心可供啓動患者治療之旅,第一位患者將於第三季度解除;預計第四季度將出現首批商業收入,2025年接受治療的患者數量將增加
Lete-cel IGNYTE-ESO pivotal trial primary analysis reports 42% overall response rate in synovial sarcoma and myxoid/round cell liposarcoma (MRCLS); full data at CTOS conference on November 16
Lete-cel IGNYTE-ESO 關鍵試驗初步分析報告稱,滑膜肉瘤和粘液樣/圓細胞脂肪肉瘤(MRCLS)的總體緩解率爲 42%;11月16日CTOS會議上的完整數據
Company restructuring to prioritize commercial sarcoma franchise and R&D programs with highest potential return on invested capital and transformational benefit to patients
公司重組,優先考慮具有最高潛在投資回報率和患者轉型收益的商業肉瘤特許經營和研發計劃
Planned 33% reduction in headcount in Q1, 2025 as part of approximately $300 million in aggregate cost savings over the next four years enables company to target an operating breakeven during 2027
作爲未來四年總共節省約3億美元成本的一部分,計劃在2025年第一季度裁員33%,這使公司能夠在2027年實現運營盈虧平衡的目標
At the end of Q3, Adaptimmune had Total Liquidity1 of $186.1 million
在第三季度末,Adaptimmune的總流動性1爲1.861億美元
Philadelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - November 13, 2024) - Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, today reports financial results and business updates for the third quarter ended September 30, 2024. The Company will host a live webcast at 4:30 p.m. EST (9:30 p.m. GMT) today.
賓夕法尼亞州費城和英國牛津--(Newsfile Corp.,2024年11月13日)——重新定義細胞療法治療實體瘤癌的公司Adaptimmune Therapeutics plc(納斯達克股票代碼:ADAP)今天公佈了截至2024年9月30日的第三季度財務業績和業務最新情況。該公司將於美國東部時間今天下午 4:30(格林尼治標準時間晚上 9:30)舉辦網絡直播。
Adrian Rawcliffe, Adaptimmune's Chief Executive Officer: "With Tecelra's encouraging launch and the new positive pivotal results for lete-cel to be presented at CTOS, Adaptimmune will redefine itself as a sarcoma-focused business. We have increased confidence in our $400 million peak year sales estimate for the combined sarcoma franchise. We're creating a new leaner company, investing in only the highest potential programs and reducing our operating expenses by around $300 million over the next four years. With these actions we have a clear path to operating breakeven during 2027."
Adaptimmune首席執行官阿德里安·羅克利夫表示:「隨着Tecelra令人鼓舞的上市,以及lete-cel將在CTOS上公佈的新的積極關鍵成果,Adaptimmune將把自己重新定義爲一家以肉瘤爲重點的企業。我們對合並肉瘤特許經營權的峯值年銷售額估計爲4億美元,增強了信心。我們正在創建一家更精簡的新公司,只投資潛力最大的項目,並在未來四年內將運營費用減少約3億美元。通過這些行動,我們有了一條在2027年實現盈虧平衡的明確途徑。」
Company focuses on strategic business plan and restructuring
公司專注於戰略業務計劃和重組
Prioritization of commercial sarcoma franchise and R&D programs with highest potential for return on invested capital and transformational benefit to patients. Tecelra launch progress and lete-cel data both support the Company's projection of combined U.S. peak year sales of $400 million for both products.
The Company plans to reduce headcount by approximately 33% and total operating expenses by approximately 25% in the first year as compared to anticipated full year 2024 together with a focus towards operations in the U.S.
The Company expects the aggregate savings over the 4-year period from 2025-2028 will be approximately $300 million, excluding one-time cost of restructuring.
The Company will cease enrolment in the SURPASS-3 Phase 2 clinical trial (NCT05601752), investigating uza-cel for the treatment of platinum-resistant ovarian cancer.
Adaptimmune's collaboration with Galapagos is underway, and plans are progressing to conduct a clinical proof-of-concept trial to evaluate the safety and efficacy of uza-cel (next-generation engineered TCR T-cell therapy, formerly ADP-A2M4CD8) using Galapagos' decentralized manufacturing platform in patients with head & neck cancer.
ADP-600 (targeting PRAME) and ADP-520 (targeting CD-70) will continue preclinical development towards IND submissions. The Company is engaged in active discussions to partner and expand these programs.
優先考慮商業肉瘤特許經營和研發計劃,這些項目可能爲患者帶來最大的投資資本回報率和轉型利益。Tecelra的發佈進展和lete-cel數據都支持該公司對這兩種產品在美國旺季總銷售額爲4億美元的預測。
與預期的2024年全年相比,該公司計劃在第一年裁員約33%,總運營支出減少約25%,並將重點放在美國的運營上。
該公司預計,在2025-2028年的4年期間,總共將節省約3億美元,其中不包括一次性重組成本。
該公司將停止參加 SURPASS-3 二期臨床試驗(NCT05601752),該試驗旨在研究uza-cel用於治療耐鉑卵巢癌。
Adaptimmune與加拉帕戈斯的合作正在進行中,計劃進行一項臨床概念驗證試驗,以評估uza-cel(下一代工程化TCR t細胞療法,前身爲 ADP-A2M4CD8)使用加拉帕戈斯的去中心化製造平台對頭頸癌患者的安全性和有效性。
ADP-600(靶向 PRAME)和 ADP-520(靶向 CD-70)將繼續進行臨床前開發,以提交新藥申請。該公司正在積極討論合作和擴展這些計劃。
Tecelra Launch
Tecelra 發佈會
Tecelra was approved by U.S. Food and Drug Administration (FDA) approved for the treatment of advanced MAGE-A4+ synovial sarcoma in adults with certain HLA types who have received prior chemotherapy.
Tecelra, a single infusion, is the first new treatment option for synovial sarcoma in more than a decade and the first engineered cell therapy for solid tumors.
9 Sarcoma centers of excellence across the U.S. are available as Authorized Treatment Centers (ATCs) for Tecelra and are accepting patients and referrals from healthcare providers to initiate the Tecelra treatment journey. The Company is confident the full ATC network of approximately 30 ATCs will be active by the end of 2025, covering an estimated 80% of patients treated in sarcoma centers of excellence.
The first patient has been apheresed and first manufacture of Tecelra is ongoing.
Tecelra已獲得美國食品藥品監督管理局(FDA)的批准,批准用於治療先前接受過化療的患有某些HLA類型的成年人的晚期MAGE-A4+滑膜肉瘤。
單次輸液Tecelra是十多年來第一個新的滑膜肉瘤治療選擇,也是第一種針對實體瘤的工程細胞療法。
美國各地的9個肉瘤卓越中心可作爲Tecelra的授權治療中心(ATC)使用,並且正在接受患者和醫療保健提供者的轉診以啓動Tecelra的治療之旅。該公司相信,到2025年底,由大約30個ATC組成的完整ATC網絡將投入使用,覆蓋在肉瘤卓越中心接受治療的估計80%的患者。
已經發現了第一位患者,Tecelra的首次生產正在進行中。
Lete-cel registrational data (details are in a separate press release issued today)
Lete-cel 註冊數據(詳情見今天發佈的另一份新聞稿)
Full primary analysis on 64 patients with long term follow up from pivotal IGNYTE-ESO trial has been completed and will be presented at the Connective Tissue Oncology Society (CTOS) annual meeting, being held in San Diego, CA from November 13 to 16, 2024:
對關鍵IGNYTE-ESO試驗的64名患者進行長期隨訪的完整初步分析已經完成,並將於2024年11月13日至16日在加利福尼亞州聖地亞哥舉行的結締組織腫瘤學會(CTOS)年會上發表:
"Planned Analysis of the Pivotal IGNYTE-ESO Trial of Lete-Cel in Patients with Synovial Sarcoma or Myxoid/Round Cell Liposarcoma (MRCLS)" by Dr. Sandra D'Angelo, M.D., Sarcoma Medical Oncology, Memorial Sloan Kettering Cancer Center, on Saturday, November 16, 10:30 AM - 12:00 PM PST, Session 12: Immunology.
Data demonstrate 42% of people with advanced or metastatic synovial sarcoma or MRCLS had clinical responses with lete-cel; Results include six complete responses (6/64) and twenty-one partial responses (21/64). Responses are durable, with a median duration of response of just over a year overall.
Adaptimmune plans to initiate a rolling Biologics License Application (BLA) for lete-cel for the treatment of advanced or metastatic MRCLS and synovial sarcoma by the end of 2025.
Lete-cel will bolster Adaptimmune's sarcoma franchise by expanding the addressable patient population to NY-ESO-1 positive MRCLS and synovial sarcoma solid tumors.
Adaptimmune will host a virtual event to review the IGNYTE-ESO dataset and the impact of engineered cell therapies on the treatment landscape in sarcoma. The event will feature Dr. Sandra D'Angelo, sarcoma medical oncologist of Memorial Sloan Kettering Cancer Center, an investigating clinician in both the SPEARHEAD and IGNYTE-ESO clinical trials, lead author and presenter of the IGNYTE-ESO data update at CTOS. To register & Attend: Adaptimmune Virtual KOL Event - LifeSci Events.
紀念斯隆·凱特琳癌症中心腫瘤內科桑德拉·安傑洛萬博士於太平洋標準時間11月16日星期六上午10點30分至中午12點太平洋標準時間上午10點30分至中午12點發表的 「針對滑膜肉瘤或粘液/圓形細胞脂肪肉瘤(MRCLS)患者的Lete-Cel的關鍵IGNYTE-ESO試驗的計劃分析」,第12節:免疫學。
數據顯示,42%的晚期或轉移性滑膜肉瘤或MRCLS患者對lete-cel有臨床反應;結果包括六種完全反應(6/64)和二十一種部分反應(21/64)。應對措施是持久的,總體反應時間中位數剛剛超過一年。
Adaptimmune計劃在2025年底之前啓動lete-cel的滾動生物製劑許可申請(BLA),用於治療晚期或轉移性MRCLS和滑膜肉瘤。
Lete-cel 將通過將可尋址患者群體擴大到 NY-ESO-1 陽性 MRCLS 和滑膜肉瘤實體瘤,加強 Adaptimmune 的肉瘤特許經營權。
Adaptimmune將舉辦一次虛擬活動,審查IGNYTE-ESO數據集以及工程細胞療法對肉瘤治療格局的影響。該活動將邀請紀念斯隆·凱特琳癌症中心的肉瘤內科腫瘤學家桑德拉·德安傑洛博士參加,他是SPEARHEAD和IGNYTE-ESO臨床試驗的研究臨床醫生,CTOSIGNYTE-ESO數據更新的主要作者和主持人。註冊並參加:Adaptimmune 虛擬 KOL 活動-LifeSCI 活動.
Recent data presentations
最近的數據演示
Translational data from the pivotal SPEARHEAD-1 trial, describing mechanisms of anti-tumor activity, durability and persistence for afami-cel (Tecelra), was presented at the Society for Immunotherapy of Cancer (SITC) 39th annual meeting by Mihaela Druta, MD, Vice Chair, Sarcoma Center, Moffitt Cancer Center, on November 8.
This presentation will also be encored at CTOS 2024 annual meeting, on Saturday, November 16 10:30 AM - 12:00 PM PST, Session 12: Immunology.
Jo Brewer, PhD., Adaptimmune's Chief Scientific Officer, delivered a platform presentation and participated in a panel discussion during SITC's Biotech Breakthroughs - Solid Tumor IO at the Tipping Point session.
莫菲特癌症中心肉瘤中心副主席、醫學博士米哈埃拉·德魯塔於11月8日在癌症免疫療法學會(SITC)第39屆年會上公佈了這項關鍵的 SPEARHEAD-1 試驗的轉化數據,描述了afami-cel(Tecelra)的抗腫瘤活性、耐久性和持久性機制。
本次演講還將在太平洋標準時間11月16日星期六上午10點30分至中午12點的CTOS 2024年年會上播出,第12場會議:免疫學。
Adaptimmune首席科學官喬·布魯爾博士在SITC的《生物技術突破——實體瘤IO臨界點》會議期間發表了平台演講,並參加了小組討論。
Today's Webcast Details
今天的網絡直播詳情
A live webcast and replay can be accessed at . Call in information is as follows: +1-844-763-8274 (US or Canada) or +1-647-484-8814 (International). Callers should dial in 10 minutes prior to the scheduled start time and simply ask to join the Adaptimmune call.
可以在以下網址觀看網絡直播和重播。電話信息如下:+1-844-763-8274(美國或加拿大)或 +1-647-484-8814(國際)。來電者應在預定開始時間前 10 分鐘撥入,只需要求加入 Adaptimmune 通話即可。
Virtual KOL Webcast Details November 18th following CTOS
CTOS 之後的 11 月 18 日虛擬 KOL 網絡直播詳情
Join Adaptimmune on Monday, November 18, 2024 at 2:30 PM ET for a virtual KOL event featuring Dr. Sandra D'Angelo, M.D. (Memorial Sloan Kettering Cancer Center) who will discuss the unmet need and current treatment landscape for patients with sarcoma, including synovial sarcoma (SyS) and myxoid/round cell liposarcoma (MRCLS).Register & Attend: Adaptimmune Virtual KOL Event - LifeSci Events
美國東部時間2024年11月18日星期一下午 2:30 加入Adaptimmune,參加虛擬KOL活動,Sandra D'Angelowand.D.(紀念斯隆·凱特琳癌症中心)將討論包括滑膜肉瘤(SyS)和粘液樣/圓形細胞脂肪肉瘤(MRCLS)在內的肉瘤患者未得到滿足的需求和當前的治療前景。註冊並參加:Adaptimmune Virtual KOL 活動-LifeSCI 活動
Financial Results for the three and nine months ended September 30, 2024
截至2024年9月30日的三個月和九個月的財務業績
Cash / liquidity position: As of September 30, 2024, Adaptimmune had cash and cash equivalents of $116.7 million and Total Liquidity2 of $186.1 million, compared to $144.0 million and $146.9 million respectively, as of December 31, 2023.
Revenue: Revenue for the three and nine months ended September 30, 2024, was $40.9 million and $174.8 million, respectively, compared to $7.3 million and $60.1 million for the same periods in 2023. Revenue has increased in 2024, compared to the same periods in 2023 primarily due to the termination of the Genentech collaboration in the second quarter of 2024, resulting in the majority of the remaining deferred income for the collaboration being recognized as revenue including a cumulative catch-up adjustment of $101.3 million, and the Mutual Release and Recognition Agreement in the third quarter of 2024 resulting in the remaining deferred revenue of $37.5 million of revenue, including the $12.5 million payment under the Mutual Release and Recognition Agreement, being recognized as revenue in the current quarter. This was significantly higher than the impact from the termination of the Astellas collaboration in 2023, which resulted in $42.4 million of revenue being recognized in March 2023. No revenue from commercial product sales was recognized in the three and nine months to September 30, 2024.
Research and development (R&D) expenses: R&D expenses for the three and nine months ended September 30, 2024, were $34.3 million and $110.0 million, respectively, compared to $37.8 million and $93.3 million for the same periods in 2023. R&D expenses in the three months ended September 30, 2024, decreased due to a decrease in subcontracted expenditures primarily due to a decrease in clinical trial expenses, offset by a decrease in offsetting reimbursements receivable for research and development tax and expenditure credits. Conversely, R&D expenses in the nine months ended September 30, 2024, increased due to an increase in the average number of employees engaged in research and development following the acquisition of TCR2 in June 2023, annual salary increases, increases in property costs, increases in manufacturing facility expenditure, an increase in in-process research and development costs and a decrease in offsetting reimbursements receivable for research and development tax and expenditure credits.
Selling, general and administrative (SG&A) expenses: SG&A expenses for the three and nine months ended September 30, 2024, were $21.2 million and $60.1 million, respectively, compared to $16.2 million and $56.6 million for the same periods in 2023. SG&A expenses increased due to an increase in accounting, legal and professional fees in due to fees relating to business development work and preparation for commercialization, offset by a decrease in restructuring charges recognised in the first quarter of 2023 that were not repeated in 2024 and an increase in offsetting reimbursements.
Net (loss)/profit: Net (loss)/profit attributable to holders of the Company's ordinary shares for the three and nine months ended September 30, 2024, was a loss of $17.6 million and a profit of $3.4 million, respectively ($(0.01) and $0.00 per ordinary share), compared to losses of $45.6 million and $66.0 million ($(0.03) and $(0.06) per ordinary share), for the same periods in 2023.
現金/流動性狀況:截至2024年9月30日,Adaptimmune的現金及現金等價物爲1.167億美元,總流動性2爲1.861億美元,而截至2023年12月31日,分別爲1.44億美元和1.469億美元。
收入:截至2024年9月30日的三個月和九個月的收入分別爲4,090萬美元和1.748億美元,而2023年同期爲730萬美元和6,010萬美元。與2023年同期相比,2024年的收入有所增加,這主要是由於基因泰克的合作在2024年第二季度終止,導致該合作的大部分剩餘遞延收益被確認爲收入,包括1.013億美元的累計補繳調整,以及2024年第三季度的相互發行和確認協議,剩餘的遞延收入爲3,750萬美元的收入,其中包括根據該支付的1,250萬美元付款相互發布和認可協議,被確認爲本季度的收入。這明顯高於2023年終止安斯泰來合作所產生的影響,後者導致2023年3月確認了4,240萬美元的收入。在截至2024年9月30日的三個月和九個月中,沒有確認任何商業產品銷售收入。
研發(R&D)費用:截至2024年9月30日的三個月和九個月的研發費用分別爲3,430萬美元和1.1億美元,而2023年同期爲3,780萬美元和9,330萬美元。在截至2024年9月30日的三個月中,研發費用減少,這是由於分包支出減少所致,這主要是由於臨床試驗費用的減少,但被研發稅收和支出抵免的抵消應收報銷的減少所抵消。相反,截至2024年9月30日的九個月中,研發費用增加,這是由於2023年6月收購TCR2後從事研發的平均員工人數增加、年度工資增長、財產成本增加、製造設施支出增加、在制研發成本增加以及研發稅收和支出抵免的抵消應收報銷減少。
銷售、一般和管理(SG&A)費用:截至2024年9月30日的三個月和九個月的銷售和收購費用分別爲2,120萬美元和6,010萬美元,而2023年同期爲1,620萬美元和5,660萬美元。銷售和收購支出增加,原因是與業務發展工作和商業化準備相關的費用導致會計、法律和專業費用增加,但被2023年第一季度確認的重組費用的減少以及抵消性報銷的增加所抵消。
淨(虧損)/利潤:截至2024年9月30日的三個月和九個月中,公司普通股持有人應占的淨(虧損)/利潤分別爲虧損1,760萬美元和340萬美元(每股普通股0.01美元)和0.00美元),而該公司的虧損爲4,560萬美元和6,600萬美元(每股普通股虧損0.03美元(0.03美元)和0.06美元)2023 年同期。
About Adaptimmune
Adaptimmune is a fully integrated cell therapy company working to redefine how cancer is treated. With its unique engineered T cell receptor (TCR) platform, the Company is developing personalized medicines designed to target and destroy difficult-to-treat solid tumor cancers and to radically improve the patient's cancer treatment experience.
關於 Adaptimmune
Adaptimmune是一家完全整合的細胞療法公司,致力於重新定義癌症的治療方式。憑藉其獨特的工程化T細胞受體(TCR)平台,該公司正在開發個性化藥物,旨在靶向和消滅難以治療的實體瘤癌,並從根本上改善患者的癌症治療體驗。
Forward-Looking Statements
This release contains "forward-looking statements" within the meaning of the safe harbor provisions of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements address our expected future business, financial performance, financial condition, as well as the results of operations and often contain words such as "anticipate" "believe," "expect," "may," "plan," "potential," "will," and similar expressions. Such statements are based only upon current expectations of Adaptimmune. Reliance should not be placed on these forward-looking statements because they involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Annual Report on Form 10-K filed with the Securities and Exchange Commission for the year ended December 31, 2023, our Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and other filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances.
前瞻性陳述
本新聞稿包含《證券法》第27A條和經修訂的1934年《證券交易法》第21E條安全港條款所指的 「前瞻性陳述」。前瞻性陳述涉及我們預期的未來業務、財務業績、財務狀況以及經營業績,通常包含 「預測」、「相信」、「期望」、「可能」、「計劃」、「潛力」、「意願」 等詞語和類似表述。此類聲明僅基於Adaptimmune當前的預期。不應依賴這些前瞻性陳述,因爲它們涉及某些風險和不確定性。此類風險和不確定性可能導致我們的實際結果與此類前瞻性陳述所示結果存在重大差異,包括但不限於:我們的產品開發活動和臨床試驗的成功、成本和時機,以及我們通過監管和商業化程序成功推進TCR候選療法的能力。要進一步描述可能導致我們的實際業績與這些前瞻性陳述中表達的業績存在重大差異的風險和不確定性以及與我們的總體業務相關的風險,請參閱我們向美國證券交易委員會提交的截至2023年12月31日止年度的10-k表年度報告、10-Q表季度報告、8-k表最新報告以及向美國證券交易委員會提交的其他文件。本新聞稿中包含的前瞻性陳述僅代表截至聲明發表之日,我們沒有義務更新此類前瞻性陳述以反映隨後的事件或情況。
Total Liquidity (a non-GAAP financial measure)
總流動性(非公認會計准則財務指標)
Total Liquidity (a non-GAAP financial measure) is the total of cash and cash equivalents and marketable securities (available-for-sale debt securities). Each of these components appears separately in the condensed consolidated balance sheet. The U.S. GAAP financial measure most directly comparable to Total Liquidity is cash and cash equivalents as reported in the condensed consolidated financial statements, which reconciles to Total Liquidity as follows (in thousands):
總流動性(非公認會計准則財務指標)是現金和現金等價物以及有價證券(可供出售的債務證券)的總和。這些組成部分分別出現在簡明的合併資產負債表中。與總流動性最直接可比的美國公認會計准則財務指標是簡明合併財務報表中報告的現金和現金等價物,該財務報表與總流動性對賬如下(以千計):
September 30, | December 31, | ||||||
2024 | 2023 | ||||||
Cash and cash equivalents | $ | 116,741 |
$ | 143,991 |
|||
Marketable securities - available-for-sale debt securities | 69,349 |
2,947 |
|||||
Total Liquidity | $ |
186,090 |
$ |
146,938 |
九月三十日 | 十二月 31, | ||||||
2024 | 2023 | ||||||
現金和現金等價物 | $ | 116,741 |
$ | 143,991 |
|||
有價證券-可供出售的債務證券 | 69,349 |
2,947 |
|||||
總流動性 | $ | 186,090 |
$ | 146,938 |
The Company believes that the presentation of Total Liquidity provides useful information to investors because management reviews Total Liquidity as part of its assessment of overall solvency and liquidity, financial flexibility, capital position and leverage.
公司認爲,總流動性的列報爲投資者提供了有用的信息,因爲管理層在評估整體償付能力和流動性、財務靈活性、資本狀況和槓桿率時對總流動性進行了審查。
Condensed Consolidated Statement of Operations
(unaudited, in thousands, except per share data)
簡明合併運營報表
(未經審計,以千計,每股數據除外)
Three months ended | Nine months ended | ||||||||||||
September 30, | September 30, | ||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||
Revenue | $ |
40,901 |
$ |
7,319 |
$ |
174,810 |
$ |
60,050 |
|||||
Operating expenses | |
|
|
|
|||||||||
Research and development | (34,304) | (37,788) | (109,959) | (93,301) | |||||||||
Selling, general and administrative | (21,277) | (16,164) | (60,092) | (56,634) | |||||||||
Total operating expenses | (55,581) | (53,952) | (170,051) | (149,935) | |||||||||
Operating (loss)/profit | (14,680) | (46,633) |
4,759 |
(89,885) | |||||||||
Interest income | 2,096 |
2,149 |
4,817 |
4,368 |
|||||||||
Interest expense | (1,109) | - |
(1,635) | - |
|||||||||
Gain on bargain purchase | - |
(106) | - |
22,049 |
|||||||||
Other income (expense), net | (3,093) | (324) | (2,657) | (494) | |||||||||
(Loss)/profit before income tax expense | (16,786) | (44,914) |
5,284 |
(63,962) | |||||||||
Income tax expense | (831) | (687) | (1,883) | (1,992) | |||||||||
Net (loss)/profit attributable to ordinary shareholders | $ | (17,617) | $ | (45,601) | $ |
3,401 |
$ | (65,954) | |||||
|
|
|
|
||||||||||
Net (loss)/profit per ordinary share | |
|
|
|
|||||||||
Basic | $ | (0.01) | $ | (0.03) | $ |
0.00 |
$ | (0.06) | |||||
Diluted | $ | (0.01) | $ | (0.03) | $ |
0.00 |
$ | (0.06) | |||||
|
|
|
|
||||||||||
|
|
|
|
||||||||||
Weighted average shares outstanding: | |
|
|
|
|||||||||
Basic | 1,534,613,977 |
1,357,849,656 |
1,506,565,234 |
1,153,791,567 |
|||||||||
Diluted | 1,534,613,977 |
1,357,849,656 |
1,537,021,778 |
1,153,791,567 |
三個月結束了 | 九個月已經結束 | ||||||||||||
九月三十日 | 九月三十日 | ||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||
收入 | $ | 40,901 |
$ | 7,319 |
$ | 174,810 |
$ | 60,050 |
|||||
運營費用 | |
|
|
|
|||||||||
研究和開發 | (34,304) | (37,788) | (109,959) | (93,301) | |||||||||
銷售、一般和管理 | (21,277) | (16,164) | (60,092) | (56,634) | |||||||||
運營費用總額 | (55,581) | (53,952) | (170,051) | (149,935) | |||||||||
營業(虧損)/利潤 | (14,680) | (46,633) | 4,759 |
(89,885) | |||||||||
利息收入 | 2,096 |
2,149 |
4,817 |
4,368 |
|||||||||
利息支出 | (1,109) | - |
(1,635) | - |
|||||||||
特價購買的收益 | - |
(106) | - |
22,049 |
|||||||||
其他收入(支出),淨額 | (3,093) | (324) | (2,657) | (494) | |||||||||
所得稅支出前(虧損)/利潤 | (16,786) | (44,914) | 5,284 |
(63,962) | |||||||||
所得稅支出 | (831) | (687) | (1,883) | (1,992) | |||||||||
歸屬於普通股股東的淨(虧損)/利潤 | $ | (17,617) | $ | (45,601) | $ | 3,401 |
$ | (65,954) | |||||
|
|
|
|
||||||||||
每股普通股淨(虧損)/利潤 | |
|
|
|
|||||||||
基本 | $ | (0.01) | $ | (0.03) | $ | 0.00 |
$ | (0.06) | |||||
稀釋 | $ | (0.01) | $ | (0.03) | $ | 0.00 |
$ | (0.06) | |||||
|
|
|
|
||||||||||
|
|
|
|
||||||||||
已發行股票的加權平均值: | |
|
|
|
|||||||||
基本 | 1,534,613,977 |
1,357,849,656 |
1,506,565,234 |
1,153,791,567 |
|||||||||
稀釋 | 1,534,613,977 |
1,357,849,656 |
1,537,021,778 |
1,153,791,567 |
Condensed Consolidated Balance Sheets
(unaudited, in thousands, except share data)
簡明合併資產負債表
(未經審計,以千計,股票數據除外)
September 30, | December 31, | ||||||
2024 | 2023 | ||||||
Assets | |||||||
Current assets | |||||||
Cash and cash equivalents | $ | 116,741 |
$ | 143,991 |
|||
Marketable securities - available-for-sale debt securities (amortized cost of $69,293 and $2,940) net of allowance for expected credit losses of $0 and $0 | 69,349 |
2,947 |
|||||
Accounts receivable, net of allowance for expected credit losses of $0 and $0 | 12,500 |
821 |
|||||
Inventory, net | 1,874 |
- |
|||||
Other current assets and prepaid expenses | 43,750 |
59,793 |
|||||
Total current assets |
244,214 |
207,552 |
|||||
|
|
||||||
Restricted cash | 2,681 |
3,026 |
|||||
Other noncurrent assets | 968 |
- |
|||||
Operating lease right-of-use assets, net of accumulated amortization of $17,243 and $13,220 | 20,494 |
20,762 |
|||||
Property, plant and equipment, net of accumulated depreciation of $55,697 and $46,020 | 44,796 |
50,946 |
|||||
Intangible assets, net of accumulated amortization of $5,525 and $5,155 | 4,283 |
330 |
|||||
Total assets | $ |
317,436 |
$ |
282,616 |
|||
|
|
||||||
Liabilities and stockholders' equity | |
|
|||||
Current liabilities | |
|
|||||
Accounts payable | $ | 9,069 |
$ | 8,128 |
|||
Operating lease liabilities, current | 4,175 |
5,384 |
|||||
Accrued expenses and other current liabilities | 31,504 |
30,303 |
|||||
Deferred revenue, current | 18,709 |
28,973 |
|||||
Total current liabilities |
63,457 |
72,788 |
|||||
|
|
||||||
Operating lease liabilities, non-current | 20,455 |
19,851 |
|||||
Deferred revenue, non-current | 98,731 |
149,060 |
|||||
Borrowings, non-current | 49,865 |
- |
|||||
Other liabilities, non-current | 4,939 |
1,404 |
|||||
Total liabilities |
237,447 |
243,103 |
|||||
|
|
||||||
Stockholders' equity | |
|
|||||
Common stock - Ordinary shares par value £0.001, 2,039,252,874 authorized and 1,534,889,490 issued and outstanding (2023: 1,702,760,280 authorized and 1,363,008,102 issued and outstanding) | 2,084 |
1,865 |
|||||
Additional paid in capital | 1,102,813 |
1,064,569 |
|||||
Accumulated other comprehensive loss | (5,136) | (3,748) | |||||
Accumulated deficit | (1,019,772) | (1,023,173) | |||||
Total stockholders' equity |
79,989 |
39,513 |
|||||
|
|
||||||
Total liabilities and stockholders' equity | $ |
317,436 |
$ |
282,616 |
九月三十日 | 十二月 31, | ||||||
2024 | 2023 | ||||||
資產 | |||||||
流動資產 | |||||||
現金和現金等價物 | $ | 116,741 |
$ | 143,991 |
|||
有價證券——扣除0美元和0美元的預期信貸損失備抵後的可供出售債務證券(攤銷成本爲69,293美元和2,940美元) | 69,349 |
2,947 |
|||||
應收賬款,扣除0美元和0美元的預期信貸損失備抵後 | 12,500 |
821 |
|||||
庫存,淨額 | 1,874 |
- |
|||||
其他流動資產和預付費用 | 43,750 |
59,793 |
|||||
流動資產總額 | 244,214 |
207,552 |
|||||
|
|
||||||
受限制的現金 | 2,681 |
3,026 |
|||||
其他非流動資產 | 968 |
- |
|||||
經營租賃使用權資產,扣除17,243美元和13,220美元的累計攤銷額 | 20,494 |
20,762 |
|||||
不動產、廠房和設備,扣除55,697美元和46,020美元的累計折舊 | 44,796 |
50,946 |
|||||
無形資產,扣除5,525美元和5,155美元的累計攤銷額 | 4,283 |
330 |
|||||
總資產 | $ | 317,436 |
$ | 282,616 |
|||
|
|
||||||
負債和股東權益 | |
|
|||||
流動負債 | |
|
|||||
應付賬款 | $ | 9,069 |
$ | 8,128 |
|||
經營租賃負債,當前 | 4,175 |
5,384 |
|||||
應計費用和其他流動負債 | 31,504 |
30,303 |
|||||
遞延收入,當前 | 18,709 |
28,973 |
|||||
流動負債總額 | 63,457 |
72,788 |
|||||
|
|
||||||
經營租賃負債,非流動 | 20,455 |
19,851 |
|||||
遞延收入,非當期 | 98,731 |
149,060 |
|||||
借款,非當期 | 49,865 |
- |
|||||
其他非流動負債 | 4,939 |
1,404 |
|||||
負債總額 | 237,447 |
243,103 |
|||||
|
|
||||||
股東權益 | |
|
|||||
普通股——普通股面值0.001英鎊,已授權2,039,252,874股,已發行和流通1,534,889,490股(2023年:授權1,702,760,280股,已發行和流通1,363,008,102股) | 2,084 |
1,865 |
|||||
額外已繳資本 | 1,102,813 |
1,064,569 |
|||||
累計其他綜合虧損 | (5,136) | (3,748) | |||||
累計赤字 | (1,019,772) | (1,023,173) | |||||
股東權益總額 | 79,989 |
39,513 |
|||||
|
|
||||||
負債和股東權益總額 | $ | 317,436 |
$ | 282,616 |
Condensed Consolidated Cash Flow Statement
(unaudited, in thousands)
簡明合併現金流量表
(未經審計,以千計)
Nine months ended | |||||||
September 30, | |||||||
2024 | 2023 | ||||||
Cash flows from operating activities | |||||||
Net profit/(loss) | $ | 3,401 |
$ | (65,954) | |||
Adjustments to reconcile net loss to net cash used in operating activities: | |
|
|||||
Depreciation | 8,156 |
6,647 |
|||||
Amortization | 234 |
322 |
|||||
Gain on bargain purchase | - |
(22,049) | |||||
Share-based compensation expense | 9,215 |
8,692 |
|||||
Unrealized foreign exchange losses | 3,164 |
709 |
|||||
Accretion on available-for-sale debt securities | (544) | (1,595) | |||||
Other | (104) | 253 |
|||||
Changes in operating assets and liabilities: | |
|
|||||
Decrease/(increase) in receivables and other operating assets | 5,426 |
(709) | |||||
Increase in inventories | (1,869) | - |
|||||
Increase/(decrease) in payables and other current liabilities | 1,173 |
(7,792) | |||||
Increase in noncurrent assets | (926) | - |
|||||
Increase in borrowings and other non-current liabilities | 1,480 |
- |
|||||
Decrease in deferred revenue | (67,808) | (44,728) | |||||
Net cash used in operating activities | (39,002) | (126,204) | |||||
|
|
||||||
Cash flows from investing activities | |
|
|||||
Acquisition of property, plant and equipment | (667) | (3,854) | |||||
Acquisition of intangible assets | (880) | (199) | |||||
Cash from acquisition of TCR2 Therapeutics Inc. | - |
45,264 |
|||||
Maturity or redemption of marketable securities | - |
139,243 |
|||||
Investment in marketable securities | (65,701) | (73,026) | |||||
Other | 129 |
913 |
|||||
Net cash (used in)/provided by investing activities | (67,119) |
108,341 |
|||||
|
|
||||||
Cash flows from financing activities | |
|
|||||
Proceeds from issuance of borrowings, net of discount | 49,500 |
- |
|||||
Proceeds from issuance of common stock from offerings, net of commissions and issuance costs | 29,171 |
623 |
|||||
Proceeds from exercise of stock options | 77 |
183 |
|||||
Net cash provided by financing activities |
78,748 |
806 |
|||||
|
|
||||||
Effect of currency exchange rate changes on cash, cash equivalents and restricted cash | (222) | 527 |
|||||
Net decrease in cash, cash equivalents and restricted cash | (27,595) | (16,530) | |||||
Cash, cash equivalents and restricted cash at start of period | 147,017 |
109,602 |
|||||
Cash, cash equivalents and restricted cash at end of period | $ |
119,422 |
$ |
93,072 |
九個月已經結束 | |||||||
九月三十日 | |||||||
2024 | 2023 | ||||||
經營活動產生的現金流 | |||||||
淨利潤/(虧損) | $ | 3,401 |
$ | (65,954) | |||
爲使淨虧損與經營活動中使用的淨現金相一致而進行的調整: | |
|
|||||
折舊 | 8,156 |
6,647 |
|||||
攤銷 | 234 |
322 |
|||||
特價購買的收益 | - |
(22,049) | |||||
基於股份的薪酬支出 | 9,215 |
8,692 |
|||||
未實現的外匯損失 | 3,164 |
709 |
|||||
可供出售債務證券的增加 | (544) | (1,595) | |||||
其他 | (104) | 253 |
|||||
運營資產和負債的變化: | |
|
|||||
應收賬款和其他運營資產減少/(增加) | 5,426 |
(709) | |||||
庫存增加 | (1,869) | - |
|||||
應付賬款和其他流動負債的增加/(減少) | 1,173 |
(7,792) | |||||
非流動資產的增加 | (926) | - |
|||||
借款和其他非流動負債的增加 | 1,480 |
- |
|||||
遞延收入減少 | (67,808) | (44,728) | |||||
用於經營活動的淨現金 | (39,002) | (126,204) | |||||
|
|
||||||
來自投資活動的現金流 | |
|
|||||
購置不動產、廠房和設備 | (667) | (3,854) | |||||
收購無形資產 | (880) | (199) | |||||
收購 TCR2 Therapeutics Inc. 產生的現金 | - |
45,264 |
|||||
有價證券的到期或贖回 | - |
139,243 |
|||||
投資有價證券 | (65,701) | (73,026) | |||||
其他 | 129 |
913 |
|||||
淨現金(用於)/由投資活動提供 | (67,119) | 108,341 |
|||||
|
|
||||||
來自融資活動的現金流 | |
|
|||||
發放借款所得的收益,扣除折扣 | 49,500 |
- |
|||||
發行普通股的收益,扣除佣金和發行成本 | 29,171 |
623 |
|||||
行使股票期權的收益 | 77 |
183 |
|||||
融資活動提供的淨現金 | 78,748 |
806 |
|||||
|
|
||||||
貨幣匯率變動對現金、現金等價物和限制性現金的影響 | (222) | 527 |
|||||
現金、現金等價物和限制性現金淨減少 | (27,595) | (16,530) | |||||
期初的現金、現金等價物和限制性現金 | 147,017 |
109,602 |
|||||
期末現金、現金等價物和限制性現金 | $ | 119,422 |
$ | 93,072 |
Adaptimmune Contact
適應免疫接點
Investor Relations
Juli P. Miller, Ph.D. - VP, Corporate Affairs and Investor Relations
T : +1 215 825 9310
M : +1 215 460 8920
Juli.Miller@adaptimmune.com
投資者關係
Juli P. Miller,博士-公司事務和投資者關係副總裁
T: +1 215 825 9310
M: +1 215 460 8920
Juli.Miller@adaptimmune.com
Media Relations
Dana Lynch, Senior Director of Corporate Communications
M: +1 267 990 1217
Dana.Lynch@adaptimmune.com
媒體關係
達娜·林奇,企業傳播高級董事
M: +1 267 990 1217
Dana.Lynch@adaptimmune.com
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1 Total liquidity is a non-GAAP financial measure, which is explained and reconciled to the most directly comparable financial measures prepared in accordance with GAAP below
2 Total liquidity is a non-GAAP financial measure, which is explained and reconciled to the most directly comparable financial measures prepared in accordance with GAAP below
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1 總流動性是一項非公認會計准則財務指標,其解釋與下文根據公認會計原則編制的最直接可比財務指標進行了解釋和對賬
2 總流動性是一項非公認會計准則財務指標,其解釋與下文根據公認會計原則編制的最直接可比財務指標進行了解釋和對賬
譯文內容由第三人軟體翻譯。