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的推出按計劃進行,目前有9個授權治療中心可以開始患者治療旅程,第一位患者在第三季度完成了血液成分分離;預計第四季度會有首批商業營業收入,並且接受治療的患者數量將在2025年加速增加。
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關鍵試驗的主要分析報告顯示在滑膜肉瘤和黏液樣/圓形細胞脂肪肉瘤(MRCLS)中,總體反應率爲42%;完整數據將在11月16日的CTOS會議上公佈。
Company restructuring to prioritize commercial sarcoma franchise and R&D programs with highest potential return on invested capital and transformational benefit to patients
公司重組以優先考慮商業肉瘤業務和具有最高投資回報潛力的研發項目,併爲患者帶來變革性利益。
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
計劃在2025年第一季度裁員33%,作爲未來四年內約30000萬總成本節約的一部分,使公司能夠在2027年實現經營收支平衡。
At the end of Q3, Adaptimmune had Total Liquidity1 of $186.1 million
截至第三季度,Adaptimmune的總流動性爲18610萬。
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)--Adaptimmune Therapeutics plc(納斯達克:ADAP),一家通過電芯療法重新定義實體腫瘤癌症治療的公司,今天發佈了截至2024年9月30日第三季度的財務業績和業務動態。該公司將在今天東部時間下午4:30(格林威治標準時間晚上9:30)進行在線網絡直播。
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."
Adrian Rawcliffe, Adaptimmune的首席執行官:"隨着Tecelra的令人鼓舞的推出以及將在CTOS上發佈的lete-cel的新積極關鍵結果,Adaptimmune將重新定義自身爲一家專注於肉瘤的企業。我們對肉瘤組合業務的40000萬營業收入峯值預估更加有信心。我們正在創建一家新的精簡公司,僅投資於最高潛力的項目,並在未來四年內將營業費用減少約30000萬。通過這些措施,我們清晰地邁向了2027年經營收支平衡的道路。"
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.
優先考慮商業骨肉瘤業務和研發項目,以實現投資資本回報和對患者的變革性益處的最高潛力。Tecelra的推出進展和lete-cel的數據均支持公司對這兩種產品在美國的峯值年銷售額達到40000萬美元的預測。
公司計劃在第一年將員工人數減少約33%,並將總營業費用減少約25%,以與預計的2024全年的比較,並專注於美國的運營。
公司預計在2025年至2028年4年期間的總節省將約爲30000萬美元,不包括一次性重組成本。
公司將停止招募SURPASS-3第二階段臨床試驗(NCT05601752),該試驗研究uza-cel治療鉑耐藥型卵巢癌。
adaptimmune therapeutics與galapagos的合作正在進行中,計劃正在進展以進行一個臨床概念驗證試驗,以評估uza-cel(下一代工程化TCR T細胞療法,前稱ADP-A2M4CD8)在頭頸癌患者中的安全性和有效性,使用galapagos的去中心化製造平台。
ADP-600(靶向PRAME)和ADP-520(靶向CD-70)將繼續向IND提交的臨床前開發。公司正在積極討論合作並擴展這些項目。
Tecelra Launch
Tecelra推出
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已獲得美國食品和藥物管理局(FDA)批准,用於治療某些HLA類型的接受過化療的成人晚期MAGE-A4+滑膜肉瘤。
Tecelra是一種單次輸注,是十多年來治療滑膜肉瘤的第一個新治療選擇,也是針對實體腫瘤的第一個工程化電芯治療。
美國有9個優秀的肉瘤中心作爲Tecelra的授權治療中心(ATC),正在接受患者和醫療提供者的推薦以開始Tecelra治療之旅。公司相信,到2025年底,約30個ATC的完整網絡將會活躍,覆蓋大約80%的在優秀肉瘤中心接受治療的患者。
首位患者已進行去血漿處理,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(詳細信息請參見今天發佈的單獨新聞稿)
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64名患者進行的主要分析已完成,並將在2024年11月13日至16日在加州聖地亞哥舉行的結締組織腫瘤學會(CTOS)年會上進行展示:
"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.
由Sandra D'Angelo博士(醫療肉瘤腫瘤學,紀念斯隆凱特林癌症中心)進行的"Lete-Cel在滑膜肉瘤或粘液/圓形細胞脂肪肉瘤(MRCLS)患者中關鍵IGNYTE-ESO試驗的計劃分析",時間爲11月16日星期六,上午10:30至中午12:00 PST,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;結果包括六個完全反應(6/64)和二十一 個部分反應(21/64)。反應是持久的,總體反應的中位持續時間超過一年。
Adaptimmune計劃在2025年底之前啓動針對晚期或轉移性MRCLS和滑膜肉瘤的lete-cel的滾動生物製品許可申請(BLA)。
Lete-cel將通過擴大可治療患者群體,包括NY-ESO-1陽性MRCLS和滑膜肉瘤實體腫瘤,增強adaptimmune therapeutics的肉瘤業務。
adaptimmune therapeutics將舉辦一場虛擬活動,審查IGNYTE-ESO數據集以及工程電芯治療對肉瘤治療領域的影響。此次活動將邀請紀念斯隆凱特琳癌症中心的肉瘤醫療腫瘤學家Sandra D'Angelo博士,她是SPEARHEAD和IGNYTE-ESO臨床試驗的研究臨床醫生,同時也是IGNYTE-ESO數據更新在CTOS會議上的主要作者和演講者。註冊與參加:adaptimmune therapeutics虛擬KOL活動 - LifeSci Events.
Recent data presentations
最近的數據展示
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.
關鍵性SPEARHEAD-1試驗的轉化數據,描述了afami-cel(Tecelra)的抗腫瘤活性機制、持久性和持續性,由Moffitt癌症中心肉瘤中心副主任Mihaela Druta醫生於11月8日在癌症免疫療法學會(SITC)第39屆年會上發佈。
該報告將在2024年CTOS年會上重播,定於11月16日星期六上午10:30至12:00 PST,第12節:免疫學。
Jo Brewer博士,adaptimmune therapeutics的首席科學官,在SITC的生物技術突破 - 實體腫瘤IO的分水嶺會議上進行了平台演講並參與了小組討論。
Today's Webcast Details
今天的網絡廣播細節
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.
可以訪問實時網絡直播和重播。電話撥入信息如下:+1-844-763-8274(美國或加拿大)或+1-647-484-8814(國際)。撥打者應在預定開始時間前10分鐘撥入,並簡單要求加入adaptimmune看漲。
Virtual KOL Webcast Details November 18th following CTOS
虛擬KOL網絡研討會細節 11月18日於CTOS後舉行
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
加入adaptimmune,時間爲2024年11月18日星期一東部時間下午2:30,參加一場由Sandra D'Angelo博士(紀念斯隆凱特琳癌症中心)主講的虛擬KOL活動,討論肉瘤患者的未滿足需求和當前治療格局,包括滑膜肉瘤(SyS)和黏液性/圓細胞脂肪肉瘤(MRCLS)。註冊並參加:adaptimmune虛擬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結果
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 $(0.06) per ordinary share), for the same periods in 2023.
現金/流動性狀況:截至2024年9月30日,adaptimmune的現金及現金等價物爲11670萬美元,流動總額爲18610萬美元,相較於2023年12月31日的14400萬美元和14690萬美元。
營收:截至2024年9月30日的三個月和九個月的營收分別爲4090萬美元和17480萬美元,相較於2023年同期的730萬美元和6010萬美元。2024年的營收相比於2023年同期有所增長,主要是由於在2024年第二季度終止與Genentech的合作,導致與合作相關的剩餘遞延收入的主要部分被確認爲營收,包括累計追溯調整的10130萬美元,以及在2024年第三季度的相互釋放和確認協議,剩餘遞延營收3750萬美元,其中包括相互釋放和確認協議下的1250萬美元支付被確認爲本季度的營收。這一影響顯著高於2023年與Astellas合作終止所造成的4240萬美元的營收在2023年3月被確認爲營收。在截至2024年9月30日的三個月和九個月內,沒有從商業產品銷售中確認任何營收。
研發費用:截至2024年9月30日的三個月和九個月的研發費用分別爲3430萬和11000萬,而2023年同期爲3780萬和9330萬。2024年9月30日截至三個月的研發費用減少,主要是由於臨床試驗費用減少,從而導致外包支出減少,部分抵消了研究與開發稅及支出抵扣的應收抵押款減少。相反,2024年9月30日截至九個月的研發費用增加,原因是自2023年6月收購TCR2後,從事研發工作的員工平均人數增加,年薪增長,物業成本增加,製造設施支出增加,進行中的研發成本增加,以及研究和開發稅及支出抵扣應收抵押款減少。
銷售、一般與行政費用:截至2024年9月30日的三個月和九個月的SG&A費用分別爲2120萬和6010萬,而2023年同期爲1620萬和5660萬。SG&A費用增加是由於因企業發展工作和商業化準備相關的會計、法律和專業費用增加,部分抵消了2023年第一季度確認的重組費用在2024年未重複和抵消報銷的增加。
淨(虧損)/利潤:截至2024年9月30日的三個月和九個月的公司普通股股東淨(虧損)/利潤分別爲虧損1760萬和利潤340萬(每股普通股分別爲$(0.01)和$0.00),而2023年同期的虧損爲4560萬和6600萬(每股普通股分別爲$(0.03)和$(0.06))。
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是一家完全一體化的細胞療法公司,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,公司正在開發個性化藥品,旨在針對難以治療的實體腫瘤癌症並顯著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.
前瞻性聲明
本發佈包含根據《證券法》27A條款和1934年《證券交易法》21E條款(修訂版)中的安全港條款所定義的「前瞻性聲明」。前瞻性聲明涉及我們預計的未來業務、財務表現、財務狀況以及運營結果,並且通常包含「預計」、「相信」、「期望」、「可能」、「計劃」、「潛在」、「將會」等類似表述。這些聲明僅基於Adaptimmune當前的預期。公衆不應依賴這些前瞻性聲明,因爲它們涉及特定的風險和不確定性。這些風險和不確定性可能導致我們的實際結果與這些前瞻性聲明中所指示的顯著不同,包括但不限於:我們產品開發活動和臨床試驗的成功、成本和時機,以及我們能否成功推動我們的TCR治療候選藥物通過監管和商業化流程。關於可能導致我們的實際結果與這些前瞻性聲明中所表達的顯著不同的風險和不確定性的進一步描述,以及關於我們業務的一般風險,我們建議您參考我們向證券交易委員會提交的截至2023年12月31日的10-K年度報告、10-Q季度報告、8-K當前報告以及其他向證券交易委員會提交的文件。本新聞稿中包含的前瞻性聲明僅在聲明作出之日有效,我們不承擔任何更新這些前瞻性聲明以反映後續事件或情況的義務。
Total Liquidity (a non-GAAP financial measure)
總流動性(非公認會計原則財務指標)
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(非公認會計原則財務指標)是現金及現金等價物和可銷售證券(可供出售的債務證券)的總和。這些元件在濃縮合並資產負債表中分別列出。與總流動性最直接可比較的美國公認會計原則財務指標是濃縮合並財務報表中報告的現金及現金等價物,按以下方式與總流動性對賬(單位:千):
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 |
9月30日 | 12月31日, | ||||||
2024 | 2023 | ||||||
現金及現金等價物 | $ | 116,741 |
$ | 143,991 |
|||
可交易證券 - 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.
公司相信,總流動性的信息對投資者是有用的,因爲管理層會將總流動性作爲評估整體償債能力和流動性、財務靈活性、資本狀況和槓桿的重要部分。
Condensed Consolidated Statement of Operations
(unaudited, in thousands, except per share data)
彙編損益統計表
(未經審計,以千爲單位,除每股數據外)
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 |
爲期三個月的截止日期 | 截至九個月 | ||||||||||||
九月三十日, | 九月三十日, | ||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||
營業收入 | $ | 40,901 |
$ | 7,319 |
$ | 174,810 |
$ | 60,050 |
|||||
營業費用 | |
|
|
|
|||||||||
研發 | (34,304) | (37,788) | (109,959) | (93,301) | |||||||||
銷售、總務和管理費用 | (21,277) | (16,164) | (60,092) | (56,634) | |||||||||
總營業費用 | (55,581) | (53,952) | (170,051) | (149,935) | |||||||||
營運(虧損)/利潤 | (14,680) | (46,633) | 4,759 |
(89,885) | |||||||||
利息收入 | 2,096 |
2,149 |
4,817 |
4,368 |
|||||||||
利息費用 | (1,109) | - |
(1,635) | - |
|||||||||
減價收購利得 | - |
(106) | - |
22,049 |
|||||||||
其他收入(費用),淨額 | (3,093) | (324) | (2,657) | (494) | |||||||||
所得稅費用前的(虧損)/利潤 | (16,786) | (44,914) | 5,284 |
(63,962) | |||||||||
所得稅費用 | (831) | (687) | (1,883) | (1,992) | |||||||||
歸屬於普通股東的淨(損失)/利潤 | $ | (17,617) | $ | (45,601) | $ | 3,401 |
$ | (65,954) | |||||
|
|
|
|
||||||||||
每普通股的淨(損失)/利潤 | |
|
|
|
|||||||||
基本 | $ | (0.01) | $ | (0.03) | $ | 0.00 |
$ | (0.06) | |||||
稀釋 | $ | (0.01) | $ | (0.03) | $ | 0.00 |
$ | (0.06) | |||||
|
|
|
|
||||||||||
|
|
|
|
||||||||||
加權平均股數: | |
|
|
|
|||||||||
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)
彙編的綜合資產負債表
(未經審計,以千爲單位,除每股數據外)
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 |
9月30日 | 12月31日, | ||||||
2024 | 2023 | ||||||
資產 | |||||||
流動資產 | |||||||
現金及現金等價物 | $ | 116,741 |
$ | 143,991 |
|||
可交易證券 - 可供出售的債務證券(攤餘成本爲$69,293和$2,940)減去預期信用損失準備金爲$0和$0 | 69,349 |
2,947 |
|||||
應收賬款,扣除預期信用損失準備$0和$0 | 12,500 |
821 |
|||||
存貨淨額 | 1,874 |
- |
|||||
其他流動資產和預付費用 | 截至2023年12月31日的未行使期權 |
59,793 |
|||||
總流動資產 | 244,214 |
207,552 |
|||||
|
|
||||||
受限現金 | 2,681 |
3,026 |
|||||
其他非流動資產 | 968 |
- |
|||||
經營租賃使用權資產,扣除累計攤銷$17,243和$13,220 | 20,494 |
20,762 |
|||||
物業、廠房和設備,扣除累計折舊$55,697和$46,020 | 44,796 |
50,946 |
|||||
無形資產,扣除累計攤銷$5,525和$5,155 | 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,流動負債 | 4,175 |
5,384 |
|||||
應計費用和其他流動負債 | 31,504 |
30,303 |
|||||
遞延收入,流動 | 18,709 |
28,973 |
|||||
流動負債合計 | 63,457 |
7,2788 |
|||||
|
|
||||||
非流動經營租賃負債 | 20,455 |
19,851 |
|||||
遞延收入,非流動 | 98,731 |
149,060 |
|||||
非流動借款 | 49,865 |
- |
|||||
其他非流動負債 | 4,939 |
1,404 |
|||||
總負債 | 237,447 |
243,103 |
|||||
|
|
||||||
股東權益 | |
|
|||||
普通股 - 面值£0.001的普通股,授權數量爲2,039,252,874股,已發行和流通數量爲1,534,889,490股(2023年:授權數量爲1,702,760,280股,已發行和流通數量爲1,363,008,102股) | 2,084 |
1,865 |
|||||
股票認購應收款項。 | 1,102,813 |
1,064,569 |
|||||
其他綜合收益累計 | (5,136) | (3,748) | |||||
累積赤字 | (1,019,772) | (1,023,173) | |||||
股東權益合計 | 79,989 |
39,513 |
|||||
|
|
||||||
負債和股東權益合計 | $ | 317,436 |
$ | 282,616 |
Condensed Consolidated Cash Flow Statement
(unaudited, in thousands)
簡化合並現金流量表
(未經審計,以千爲單位)
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 |
截至九個月 | |||||||
九月三十日, | |||||||
2024 | 2023 | ||||||
經營活動現金流量 | |||||||
淨利潤/(虧損) | $ | 3,401 |
$ | (65,954) | |||
調整爲淨損失到經營活動現金流量淨使用: | |
|
|||||
折舊 | 8,156 |
6,647 |
|||||
攤銷 | 234 |
322 |
|||||
減價收購利得 | - |
(22,049) | |||||
基於股票的補償費用 | 9,215 |
8,692 |
|||||
匯率期貨未實現損失 | 3,164 |
709 |
|||||
可供出售債務證券的增值 | (544) | (1,595) | |||||
其他 | (104) | 253 |
|||||
運營資產和負債的變化: | |
|
|||||
應收賬款和其他營業資產的減少/(增加) | 5,426 |
(709) | |||||
存貨的增加 | (1869) | - |
|||||
應付賬款及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) | |||||
|
|
||||||
投資活動現金流量 | |
|
|||||
購置固定資產 | (667) | (3,854) | |||||
購置無形資產 | (880) | (199) | |||||
收購TCR2 Therapeutics Inc.的現金 | - |
45,264 |
|||||
可交易證券的到期或贖回 | - |
139,243 |
|||||
投資可交易證券 | (65,701) | (73,026) | |||||
其他 | 129 |
913 |
|||||
投資活動產生的淨現金流量 | (67,119) | 108,341 |
|||||
|
|
||||||
籌資活動現金流量 | |
|
|||||
發行借款的收益,扣除折扣後 | 49,500 |
- |
|||||
發行普通股的收入,扣除佣金和發行費用後淨額 | 29,171 |
623 |
|||||
行使股票期權所得 | 77 |
183 |
|||||
籌資活動產生的現金淨額 | 78,748 |
806 |
|||||
|
|
||||||
貨幣匯率變動對現金、現金等價物和受限制的現金的影響 | (222) | 527 |
|||||
現金、現金等價物和受限制現金淨減少額 | (27,595) | (16,530) | |||||
期初現金、現金等價物和受限制的現金 | 147,017 |
109,602 |
|||||
期末現金、現金等價物及受限制的現金餘額 | $ | 119,422 |
$ | 93,072 |
Adaptimmune Contact
Adaptimmune聯繫方式
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-企業事務和投資者關係副總裁
電話:+1 215 825 9310
手機:+1 215 460 8920
電子郵件: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
Dana Lynch,企業傳播高級總監
手機:+1 267 990 1217
電子郵件: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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總流動性是一個非GAAP財務指標,下面解釋並與根據GAAP準備的最直接可比財務指標進行了對賬。
總流動性是一個非美國通用會計準則的財務指標,下面解釋並與根據美國通用會計準則準備的最直接可比財務指標進行調節。
譯文內容由第三人軟體翻譯。