使用警語:中文譯文來源為 AI 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Good day, and thank you for standing by. Welcome to the Iovance Biotherapeutics first-quarter 2026 financial results conference call. (Operator Instructions) Please be advised that today's conference is being recorded.
各位好,感謝您稍候。歡迎參加 Iovance Biotherapeutics 2026 年第一季財務業績電話會議。(接線員指示) 請注意,今天的會議將被錄音。
I would now like to hand the conference over to your speaker today, Sara Pellegrino, SVP of Investor Relations and Corporate Communications. Please go ahead.
現在我想把會議交給今天的發言人,投資人關係與企業傳播資深副總裁 Sara Pellegrino。請開始。
Sara Pellegrino - SVP, IR and Corporate Communications
Sara Pellegrino - SVP, IR and Corporate Communications
Thank you, operator. Good morning, and welcome to the Iovance webcast to discuss our first-quarter 2026 financial results, business achievements, and corporate updates. This morning, we issued a press release that is available on our corporate website at iovance.com.
謝謝,接線員。各位早安,歡迎參加 Iovance 的網路直播,我們將討論 2026 年第一季財務業績、業務里程碑與公司最新進展。今天早上我們已發布新聞稿,可於公司網站 iovance.com 查閱。
This conference call will include forward-looking statements regarding Iovance's goals, business focus, business plans and transactions, revenue and revenue guidance, commercial activities, clinical trials and results, regulatory approvals, submissions, feedback and guidance, plans and strategies, research and preclinical activities, potential future applications of our technologies, manufacturing capabilities, payer interactions, licenses and collaboration, cash position and expense guidance, and future updates.
本次電話會議將包含前瞻性陳述,內容涉及 Iovance 的目標、業務重點、業務計畫與交易、營收與營收指引、商業活動、臨床試驗與結果、法規核准、申報、回饋與指引、計畫與策略、研究與臨床前活動、我們技術的潛在未來應用、製造能力、與支付方的互動、授權與合作、現金部位與費用指引,以及未來更新。
Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our SEC filings. Our results may differ materially from those projected during today's call. We undertake no obligation to publicly update any forward-looking statement.
前瞻性陳述受多項風險與不確定性影響,其中許多超出我們的控制範圍,包括我們不時於向 SEC 提交的文件中所描述的風險與不確定性。我們的實際結果可能與今日電話會議中所預測者有重大差異。我們不承擔公開更新任何前瞻性陳述的義務。
I will now turn the call over to Dr. Frederick Vogt, our Interim Chief Executive Officer and President.
接下來我將把電話會議交給我們的臨時執行長兼總裁 Frederick Vogt 博士。
Frederick Vogt - Interim President, Interim Chief Executive Officer, General Counsel, Corporate Secretary
Frederick Vogt - Interim President, Interim Chief Executive Officer, General Counsel, Corporate Secretary
Thank you, Sara. Iovance is a global leader in innovating, developing, and delivering current and future generations of TIL cell therapy in solid tumors. We are executing to maximize patient and shareholder value across four pillars: curative platform potential, commercial execution, technology extension, and fully owned manufacturing. During the first quarter of 2026, we drove AMTAGVI adoption, advanced our development pipeline, and streamlined costs and efficiencies.
謝謝你,Sara。Iovance 是全球在實體腫瘤領域創新、開發並提供現有與未來世代 TIL 細胞療法的領導者。我們正透過四大支柱執行,以最大化病患與股東價值:具治癒潛力的平台、商業化執行、技術延伸,以及完全自有的製造能力。在 2026 年第一季,我們推動 AMTAGVI 的採用、推進研發管線,並精簡成本與提升效率。
First-quarter revenue grew approximately 45% year over year. Owning manufacturing is critical for our success. We navigated a temporary capacity reduction to complete maintenance upgrades at our internal manufacturing facility, the iCTC. Since resuming full production, AMTAGVI is now exclusively manufactured in-house, and our modular facility can provide uninterrupted supply while supporting global demand and scale. Research and development expenses declined for the third consecutive quarter, helping to extend our cash runway into 2028.
第一季營收年增約 45%。自有製造對我們的成功至關重要。我們在內部製造設施 iCTC 完成維護升級期間,因應了短暫的產能下降。恢復全面生產後,AMTAGVI 現已完全由內部製造;我們的模組化設施可在支援全球需求與擴產的同時,提供不中斷的供應。研發費用連續第三季下降,有助於將我們的現金使用期延長至 2028 年。
Looking ahead, AMTAGVI enrollment and referral trends are at an all-time high in support of our second-quarter and full-year 2026 guidance issued today. Second-quarter total revenue guidance is $86 million to $88 million. AMTAGVI revenue is expected to grow to $79 million to $81 million in the second quarter.
展望未來,AMTAGVI 的收案與轉介趨勢創下歷史新高,支撐我們今日發布的第二季與 2026 全年指引。第二季總營收指引為 8,600 萬至 8,800 萬美元。預期 AMTAGVI 第二季營收將成長至 7,900 萬至 8,100 萬美元。
This is an increase of approximately 23% over our highest quarterly revenue to date in the fourth quarter of last year. For the full-year 2026, total revenue guidance for AMTAGVI and PROLEUKIN is $350 million to $370 million, predominantly fueled by AMTAGVI. Over time, we project a $1 billion peak -- $1 billion plus (inaudible) sales trajectory for AMTAGVI and PROLEUKIN in the US. For the rest of 2026 and beyond, we expect gross margins to benefit from our financial discipline, in-house scale, and operational efficiencies.
這較去年第四季迄今最高的單季營收增加約 23%。2026 全年,AMTAGVI 與 PROLEUKIN 的總營收指引為 3.5 億至 3.7 億美元,主要由 AMTAGVI 驅動。隨時間推進,我們預期 AMTAGVI 與 PROLEUKIN 在美國的銷售軌跡可達 10 億美元峰值——10 億美元以上(聽不清)。在 2026 年剩餘期間及之後,我們預期毛利率將受惠於財務紀律、內部規模化與營運效率提升。
Shifting to our TIL platform, we're expanding the curative potential across solid tumors. This morning, we announced compelling and clinically differentiated early Phase 2 data in metastatic serous endometrial cancer. The confirmed objective response rate was 40% with a 100% disease control rate in the first five patients. Metastatic serous endometrial cancer is difficult to treat with an estimated 5,000 annual US deaths.
接著談到我們的 TIL 平台,我們正將治癒潛力擴展至更多實體腫瘤。今天早上,我們公布了在轉移性漿液性子宮內膜癌中具說服力且在臨床上具差異化的早期第二期數據。在前五位病患中,確認的客觀緩解率為 40%,疾病控制率為 100%。轉移性漿液性子宮內膜癌難以治療,估計美國每年約有 5,000 人死亡。
The second-line treatment setting represents a significant unmet medical need with response rates below 15%. We plan to engage with the US FDA to pursue an expedited approval pathway. I will now highlight additional registrational trials for lifileucel and new indications.
第二線治療情境存在顯著未被滿足的醫療需求,反應率低於 15%。我們計畫與美國 FDA 互動,以尋求加速核准途徑。接下來我將重點說明 lifileucel 的其他註冊性試驗與新適應症。
To expand the AMTAGVI's market potential into advanced frontline melanoma, we continue to execute our global TILVANCE-301 trial. In previously treated non-squamous, non-small cell lung cancer, lifileucel received FDA Fast Track designation following best-in-class unprecedented response rate and strong durability. This US blockbuster market is about seven times larger than our peak opportunity in advanced melanoma. We plan to complete enrollment and provide a clinical update this year, targeting accelerated approval and US launch in the second half of 2027.
為將 AMTAGVI 的市場潛力擴展至晚期一線黑色素瘤,我們持續推進全球 TILVANCE-301 試驗。在既往治療過的非鱗狀非小細胞肺癌中,lifileucel 因同類最佳、前所未有的反應率與強勁的持久性而獲得 FDA 快速通道(Fast Track)認定。此美國重磅市場規模約為我們在晚期黑色素瘤峰值機會的七倍。我們計畫於今年完成收案並提供臨床更新,目標在 2027 年下半年取得加速核准並於美國上市。
In advanced and difficult to treat soft tissue sarcomas, IOV-SAR-201, our new registrational trial, is underway in refractory patients with advanced undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma. The trial is beginning enrollment in the third quarter of 2026. We are building upon positive early clinical results with a 50% confirmed response rate in comparison to the abysmal response rates of less than 5% with current standard of care. We are actively engaging with FDA soon on a path to accelerated approval.
在晚期且難以治療的軟組織肉瘤中,我們新的註冊性試驗 IOV-SAR-201 已在對治療無反應的病患中展開,涵蓋晚期未分化多形性肉瘤與去分化脂肪肉瘤。該試驗預計於 2026 年第三季開始收案。我們將在正向的早期臨床結果基礎上持續推進:確認反應率達 50%,相較之下,現行標準治療的反應率低得可憐,不足 5%。我們正積極並將於近期與 FDA 討論加速核准的途徑。
As the global leader in TIL cell therapy, we are making significant progress to our next generation programs. IOV-5001 is our IL-12 tethered TIL therapy for highly prevalent solid tumors. A prior generation IL-12 TIL therapy at the National Cancer Institute improved clinical efficacy without IL-2 and informs how we optimize IOV-5001 to enhance efficacy and safety. We recently submitted the investigational new drug or IND application for a Phase 1/2 clinical trial, which includes indications that represent more than 15% of US cancer deaths annually.
作為全球 TIL 細胞療法的領導者,我們在下一世代計畫上取得重大進展。IOV-5001 是我們的 IL-12 錨定(tethered)TIL 療法,針對高盛行率的實體腫瘤。美國國家癌症研究院(NCI)先前一代的 IL-12 TIL 療法在不使用 IL-2 的情況下提升了臨床療效,並為我們如何最佳化 IOV-5001 以提升療效與安全性提供指引。我們近期已提交一期/二期臨床試驗的研究用新藥(IND)申請,其中包含的適應症合計占美國每年癌症死亡人數超過 15%。
Among these indications are advanced colorectal cancer as well as triple-negative and estrogen receptor-low breast cancers, adding large populations of massive commercial opportunities to our strategy. The trial is expected to begin in the second half of 2026. Our next generation IL-2 product, IOV-3001, may optimize the TIL treatment regimen. A Phase 1 safety cohort using IOV-3001 is advancing through multiple dose levels in a Phase 1/2 trial.
這些適應症包括晚期大腸直腸癌,以及三陰性與雌激素受體低表現乳癌,為我們的策略新增龐大族群與巨大的商業機會。該試驗預計於 2026 年下半年啟動。我們的下一世代 IL-2 產品 IOV-3001 可能可最佳化 TIL 的治療方案。在一期/二期試驗中,使用 IOV-3001 的一期安全性隊列正於多個劑量層級推進。
We continue to enroll in our clinical trial with our PD-1 inactivated TIL therapy, IOV-4001, which reduces inhibitory signals to enhance the ability of TIL therapies to fight and kill cancer. We are initially exploring melanoma and non-small cell lung cancer. We look forward to reporting data and updates soon.
我們持續在 PD-1 失活的 TIL 療法 IOV-4001 臨床試驗中收案;該療法可降低抑制性訊號,以增強 TIL 療法對抗並殺死癌細胞的能力。我們初期將探索黑色素瘤與非小細胞肺癌。我們期待很快公布數據與最新進展。
As we expand our clinical strategy in solid tumor cancers, we now have the opportunity and capability to identify and enrich patient populations that are highly responsive to TIL therapy. We are identifying these enriched populations, such as the serous endometrial cancer population we highlighted today, and our selected populations within soft tissue sarcomas and even within non-small cell lung cancer and other indications, which you will hear more about later this year.
隨著我們在實體腫瘤癌症中擴展臨床策略,我們如今具備機會與能力去辨識並富集對 TIL 療法高度反應的病患族群。我們正在辨識這些富集族群,例如我們今天重點提到的漿液性子宮內膜癌族群,以及我們在軟組織肉瘤中所選定的族群,甚至在非小細胞肺癌與其他適應症中的特定族群;您將在今年稍晚聽到更多相關內容。
Iovance is well-positioned as the only company to have taken TIL therapy from concept to commercial scale with the manufacturing infrastructure, clinical breadth, commercial experience and operational discipline to back it up. We have momentum, a broadening pipeline, and improving line of sight to profitability. The foundation is built, and as we continue to expand across indications, our ambition is clear. To extend our leadership not just in TIL therapy, but as the backbone of immune oncology and solid tumor cancers.
Iovance 具備優勢,作為唯一一家將 TIL 療法從概念推進到商業化規模的公司,並擁有相應的製造基礎設施、臨床廣度、商業經驗與營運紀律作為後盾。我們具備動能、產品線持續擴大,且對獲利的可視性正在提升。基礎已經建立,隨著我們持續擴展至更多適應症,我們的企圖心十分明確。不僅要延伸我們在 TIL 療法的領導地位,更要成為免疫腫瘤學與實體腫瘤癌症的骨幹。
As I conclude this pipeline update, I would like to extend my sincere gratitude to Friedrich Graf Finckenstein, our Chief Medical Officer, as he prepares to retire in June. During nearly seven years at Iovance, he was instrumental in leading us towards the FDA approval of the first-ever TIL therapy and our leadership position today. Friedrich is available during today's question-and-answer session, and I wish him the best in his retirement.
在我結束此次產品線更新之際,我想向我們的首席醫療官 Friedrich Graf Finckenstein 致上誠摯的感謝,他將於六月準備退休。在 Iovance 近七年的期間,他在帶領我們取得史上首個 TIL 療法的 FDA 核准,以及奠定我們今日的領導地位方面,發揮了關鍵作用。Friedrich 也會出席今天的問答環節,並祝福他退休生活一切順利。
I will now turn the call over to Corleen Roche, our Chief Financial Officer, who will provide further updates on our first-quarter financials and full year expectations. Corleen?
接下來我將把電話會議交給我們的首席財務官 Corleen Roche,她將就第一季財務表現與全年展望提供進一步更新。Corleen?
Corleen Roche - Chief Financial Officer
Corleen Roche - Chief Financial Officer
Thanks, Fred, and good morning, everyone. Our commitment to operational excellence, commercial growth, and financial discipline drove strong top-line year-over-year growth and meaningful cost containment in the first quarter. We transformed our internal manufacturing facility to meet demand growth and scale for the future without major additional capital investment.
謝謝你,Fred,各位早安。我們對營運卓越、商業成長與財務紀律的承諾,推動第一季營收年增強勁,並在成本控管上取得顯著成效。我們在未進行重大額外資本投資的情況下,完成內部製造設施的轉型,以因應需求成長並為未來擴產做準備。
First-quarter revenue of $71 million grew roughly 45% year over year, driven by strong AMTAGVI demand. AMTAGVI revenue of $60 million increased by 38% year over year on strong demand growth, our second-highest quarterly revenue for AMTAGVI. We mitigated the first-quarter impact from a temporary capacity reduction as we upgraded our facility.
第一季營收為 7,100 萬美元,年增約 45%,主要由 AMTAGVI 的強勁需求帶動。AMTAGVI 營收為 6,000 萬美元,在需求強勁成長下年增 38%,為 AMTAGVI 歷來第二高的單季營收。在我們升級設施期間,針對暫時性產能下降對第一季造成的影響,我們已加以緩解。
Moving to PROLEUKIN, $11 million in first quarter revenue nearly doubled from the year ago period on higher AMTAGVI adoption. Importantly, gross to net impact remains extraordinary and consistent with past quarters at less than 2%. Our first-quarter gross margin from cost of sales was about 41%, which absorbed one-time non-recurring costs related to our facility upgrades. Margin is expected to trend higher for the rest of 2026, excluding one-time items, as we operate our in-house capabilities more efficiently.
接著談 PROLEUKIN,第一季營收為 1,100 萬美元,因 AMTAGVI 採用率提升,較去年同期幾乎翻倍。重要的是,毛額到淨額(gross-to-net)的影響仍然非常低,且與過去季度一致,低於 2%。第一季銷貨成本口徑的毛利率約為 41%,其中已吸收與設施升級相關的一次性、非經常性成本。展望 2026 年其餘期間,若排除一次性項目,隨著我們更有效率地運作自有產能,毛利率預期將呈上升趨勢。
We continue to manage our operating expenses carefully, including optimizing research and development while expanding our pipeline. Notably, research and development expense declined for the third consecutive quarter, a reduction of 18% over the prior period and 12% over the prior quarter.
我們持續審慎管理營運費用,包括在擴展產品線的同時,優化研發支出。值得注意的是,研發費用已連續第三季下降,較前一期間下降 18%,較前一季下降 12%。
Moving to our revenue outlook. After thorough analysis of demand trends and internal forecasts, we expect total revenue between $86 million and $88 million for the second quarter, driven by strong AMTAGVI demand. This momentum carries through into our full-year 2026 guidance of $350 million to $370 million for the full year.
接著談營收展望。在對需求趨勢與內部預測進行全面分析後,我們預期第二季總營收將介於 8,600 萬至 8,800 萬美元,主要由 AMTAGVI 的強勁需求帶動。此一動能也延續至我們 2026 全年指引,全年營收預估為 3.50 億至 3.70 億美元。
As of March 31, we had approximately $319 million in cash and equivalents. Thanks to careful cost management and financial discipline, we expect to fund our operations into 2028. In closing, we are building momentum and focusing on operational excellence to grow revenue, manage expenses, and improve margins. We are on a clear path to profitability and remain committed to creating lasting value for our shareholders.
截至 3 月 31 日,我們持有約 3.19 億美元的現金及約當現金。受惠於審慎的成本管理與財務紀律,我們預期可支應營運至 2028 年。最後,我們正在累積動能並聚焦營運卓越,以推動營收成長、管理費用並改善毛利率。我們正走在明確的獲利道路上,並將持續致力於為股東創造長期價值。
I will now turn the call to Dan Kirby, our Chief Commercial Officer, to review our strong commercial progress.
接下來我將把電話會議交給我們的首席商務官 Dan Kirby,請他回顧我們強勁的商業進展。
Daniel Kirby - Chief Commercial Officer
Daniel Kirby - Chief Commercial Officer
Thank you, Corleen. Building on Corleen's comments, strong demand in the first quarter culminated in our second-highest quarter of AMTAGVI revenue. This performance was achieved with reduced capacity and yielded much better results compared to the first quarter of 2025. Demand continued to increase throughout the quarter. March was our largest month ever for reported AMTAGVI revenue.
謝謝你,Corleen。延續 Corleen 的說明,第一季的強勁需求使 AMTAGVI 營收創下我們歷來第二高的單季表現。這項成果是在產能降低的情況下達成,且相較 2025 年第一季取得更好的結果。整個季度需求持續增加。3 月是我們 AMTAGVI 申報營收史上最高的單月。
Second quarter is off to a very strong start with projections supporting our guidance that this will be our best AMTAGVI quarter to date. In addition to generating demand, our three commercial priorities are further solidifying AMTAGVI as the choice for patients.
第二季開局非常強勁,相關預測支持我們的指引:這將是 AMTAGVI 迄今表現最佳的一季。除了創造需求之外,我們的三項商業優先事項是進一步鞏固 AMTAGVI 作為病患的首選。
First, our expanding ATC network of academic ATCs together with new community ATCs are creating more patients, establishing both a reliable base of business as well as driving additional growth in 2026. Second, patients are increasingly referred for AMTAGVI earlier in the treatment cycle. The recently published real-world evidence, combined with published five-year durability data, has been very impactful in educating physicians on the value of earlier referrals and optimal treatment with AMTAGVI. Our field teams are committed to educating our physicians while advocating for our patients.
第一,我們持續擴大的 ATC 網絡,由學術型 ATC 與新增的社區型 ATC 共同推動,正在帶來更多病患,既建立可靠的業務基礎,也在 2026 年帶動額外成長。第二,病患在治療週期中更早被轉介使用 AMTAGVI 的趨勢日益明顯。近期發表的真實世界證據,加上已發表的五年持久性數據,在教育醫師理解更早轉介與以 AMTAGVI 進行最佳治療的價值方面,影響非常顯著。我們的前線團隊致力於教育醫師,同時為病患發聲。
Third, AMTAGVI awareness continues to build among our key target physicians. Our latest market research shows physician awareness increased to 70%, up from 50% over the last six months. Earlier this year, we further expanded our field sales force with plans for additional increases in field staff as more ATCs onboard and demand continues to strengthen.
第三,AMTAGVI 在我們關鍵目標醫師族群中的知名度持續提升。我們最新的市場研究顯示,醫師知悉度已提升至 70%,較過去六個月的 50% 明顯上升。今年稍早,我們進一步擴編前線銷售團隊,並計畫隨著更多 ATC 上線及需求持續增強,進一步增加外勤人員。
PROLEUKIN is seeing robust demand, driven primarily by its use alongside AMTAGVI. PROLEUKIN sales were $11 million in the first quarter, down from the prior quarter due to wholesale buying patterns, but a substantial increase from the prior year as all three wholesalers ordered. We expect PROLEUKIN to stabilize and grow throughout the year with increasing AMTAGVI demand.
PROLEUKIN 的需求表現強勁,主要由其與 AMTAGVI 併用所帶動。PROLEUKIN 第一季銷售額為 1,100 萬美元,因批發端採購節奏影響而較前一季下降,但由於三家批發商皆有下單,較去年同期大幅增加。我們預期 PROLEUKIN 將在全年逐步趨於穩定並成長,並隨 AMTAGVI 需求增加而受益。
Globally, we are making meaningful progress on ex-US expansion. AMTAGVI has the potential to reach more than 30,000 patients annually with previously treated advanced melanoma. Following AMTAGVI approval in Canada, the first ex-US treatment center is officially authorized to support international private pay patients.
在全球方面,我們在美國以外市場的擴張取得實質進展。AMTAGVI 有潛力每年觸及超過 30,000 名既往治療過的晚期黑色素瘤病患。在 AMTAGVI 於加拿大獲准後,首家美國以外的治療中心已正式獲授權,以支援國際自費病患。
At the same time, we are advancing reimbursement discussions with the Canadian government. Regulatory decisions are anticipated in Australia in the first half of this year and in Switzerland next year. We continued making progress with regulatory submissions in other markets as well. Finally, May is Melanoma Awareness Month. We are collaborating with advocacy groups to celebrate the patient experience while spreading awareness of AMTAGVI.
同時,我們也正與加拿大政府推進給付(reimbursement)相關討論。預期澳洲將於今年上半年做出監管決定,瑞士則預計於明年做出決定。我們也持續在其他市場推進監管申請。最後,5 月是黑色素瘤宣導月。我們正與倡議團體合作,慶祝病患的治療歷程,同時提升對 AMTAGVI 的認識。
Yesterday, the Today Show posted an inspiring story highlighting Jennifer, a mother of three, who is back to enjoying her family after receiving AMTAGVI more than a year ago. Her story is one of many that represents the hope of AMTAGVI. Jennifer is now also featured on our website, amtagvi.com. A growing network of patients are sharing how this one-time cell therapy has helped their own immune system fight cancer.
昨天,《Today Show》刊登了一則振奮人心的故事,聚焦於三個孩子的母親 Jennifer;她在接受 AMTAGVI 治療一年多後,已能重新享受與家人相處的時光。她的故事只是眾多案例之一,代表著 AMTAGVI 所帶來的希望。Jennifer 現在也登上我們的網站 amtagvi.com。越來越多病患正在分享,這項一次性細胞療法如何幫助他們自身的免疫系統對抗癌症。
I will now hand the call back to the operator to begin question and answers.
接下來我將把電話會議交回給接線員,開始問答環節。
Operator
Operator
(Operator Instructions) Andrew Tsai, Jefferies.
(接線員指示)Andrew Tsai,Jefferies。
Unidentified Participant
Unidentified Participant
This is John on for Andrew. Congrats on all the progress. For Q2, if your AMTAGVI sales guidance of $79 million to $81 million, how much can that improve gross margins quarter over quarter as well? And then can we assume that the Q2 gross margins will be better than the Q4 gross margins at 50%?
我是 John,代替 Andrew 發言。恭喜你們取得所有進展。針對第二季(Q2),若你們對 AMTAGVI 的銷售指引為 7,900 萬至 8,100 萬美元,這在毛利率方面相較上一季可改善多少?另外,我們是否可以假設 Q2 的毛利率會優於第四季(Q4)50% 的毛利率?
Frederick Vogt - Interim President, Interim Chief Executive Officer, General Counsel, Corporate Secretary
Frederick Vogt - Interim President, Interim Chief Executive Officer, General Counsel, Corporate Secretary
Yeah. Thanks, John. Well, obviously, the margins we showed in Q4 of 2025 were really where we aspire to be or above that. We can't say just yet where our margins are going to be exactly. But I would expect generally that they will trend upwards throughout the year. We're working very hard on that. It depends a lot on the product mix and a lot of other factors. But we really do want margins to be better throughout the year. Of course, in the 2027 and beyond, we're driving towards higher and higher margins all the time.
是的。謝謝你,John。嗯,顯然我們在 2025 年第四季所呈現的毛利率,確實是我們希望達到的水準,甚至高於該水準。我們目前還不能明確說毛利率最終會落在什麼位置。但我一般預期毛利率會在全年呈上升趨勢。我們正為此非常努力。這很大程度取決於產品組合以及許多其他因素。但我們確實希望毛利率在全年都能更好。當然,在 2027 年及之後,我們會持續推動毛利率越來越高。
Corleen Roche - Chief Financial Officer
Corleen Roche - Chief Financial Officer
Yeah. Just to emphasize, John, the margin was impacted, like I mentioned, from one-time non-recurring costs. That should not happen again. It will be non-recurring. Our margins should be continuing to grow. As I keep mentioning, we have a lot of efforts. We brought everything in-house, right? We use the capacity of our own facility. We'll have economies of scale there. We also have targeted projects focused on operational excellence in the plant specifically.
是的。再強調一下,John,如我提到的,毛利率受到一次性、非經常性成本的影響。這種情況不應該再發生。它將是非經常性的。我們的毛利率應會持續成長。如我一直提到的,我們有很多努力在進行。我們把所有事情都內部化了,對吧?我們使用自有廠房的產能。我們將在那裡取得規模經濟。我們也有一些針對性專案,特別聚焦於工廠的營運卓越。
And as you see, as revenue grows, that also helps. Does that help you?
而且如你所見,隨著營收成長,這也會有所幫助。這樣有回答到你的問題嗎?
Unidentified Participant
Unidentified Participant
Yeah, definitely. And then also maybe just a quick follow up, if I can. Is it fair to assume that the lung data would come at a major medical meeting in the second half of 2026 versus something like Q2 at ASCO? And then would you be inclined to press release the data before? Any timing granularity would be helpful. Maybe also just remind us your expectations on ORR and potentially even DOR.
有,當然。另外如果可以的話,再快速追問一下。我們是否可以合理假設,肺癌數據會在 2026 年下半年某個重要醫學會議上公布,而不是像第二季在 ASCO 之類的會議?另外,你們會傾向在會議前先發布新聞稿公布數據嗎?任何更細的時間點資訊都會很有幫助。也請再提醒我們你們對 ORR 的預期,以及可能的 DOR。
Frederick Vogt - Interim President, Interim Chief Executive Officer, General Counsel, Corporate Secretary
Frederick Vogt - Interim President, Interim Chief Executive Officer, General Counsel, Corporate Secretary
Yeah, as you can see, we really stayed in lung only about six months ago that had excellent durability, which is typical of immuno-oncology approaches that work really well. So you can go back and look at our November press release that that's basically what we're looking at for this product and what we think is something that we can get approved, non-squamous non-small cell lung.
是的,如你所見,我們大約在六個月前才在肺癌領域取得結果,且顯示出極佳的持久性,這也是免疫腫瘤學方法在效果很好時的典型特徵。所以你可以回去看我們 11 月的新聞稿;那基本上就是我們對這個產品的觀察重點,以及我們認為可望取得核准的適應症:非鱗狀非小細胞肺癌。
I can't really say much more about conference stuff except that we've got it obviously to 2026 disclosure at a medical meeting and we continue to plan to do that.
關於會議相關的事情我其實不能多說;只能說我們顯然計畫在 2026 年於某個醫學會議上揭露資料,而且我們會持續依此規劃。
Unidentified Participant
Unidentified Participant
Thanks so much.
非常感謝。
Operator
Operator
Reni Benjamin, Citizens.
Reni Benjamin,Citizens。
Reni Benjamin - Analyst
Reni Benjamin - Analyst
Thanks for taking the questions and congrats on the progress. Maybe two questions. One, as we think about the ATC network, they're now greater than 90, I think you're targeting 110 by the year end. Can you maybe talk to us a little bit about what the split will be between these academic ATCs and community ATCs?
謝謝讓我提問,也恭喜你們的進展。我有兩個問題。第一,談到 ATC 網絡,目前已超過 90 家,我想你們目標是在年底達到 110 家。你們能否談談這些學術型 ATC 與社區型 ATC 之間的比例會如何分配?
And what do you think will be the max capacity across these ATCs that I think (inaudible) may have mentioned that the sales force is going to be growing throughout this year. Can you give us an idea as to what the optimal number of that may be? That's the commercial question.
另外,你認為這些 ATC 的最大產能會是多少?我想(聽不清)可能提到銷售團隊今年會持續擴編。你能否讓我們了解一下最適合的銷售人數大概是多少?這是商業面的問題。
One for Friedrich, because it will be the last time that we're speaking to him. Congratulations, Friedrich, on retirement. Kind of wanted to just get a sense as to the 40% confirmed ORR in endometrial, kind of your thoughts and any kind of details you can provide us in terms of depth of response or durability and how it compares to what's already out there.
還有一個問題給 Friedrich,因為這將是我們最後一次與他對話。Friedrich,恭喜你退休。我想了解一下子宮內膜癌中 40% 的已確認 ORR,你的看法是什麼?以及你能否提供任何關於反應深度或持久性(durability)的細節,並與目前市面上既有療法做比較。
Daniel Kirby - Chief Commercial Officer
Daniel Kirby - Chief Commercial Officer
All right. So Reni, thank you very much for the question. I'll start first then hand to Friedrich. In regard to the ATC network, we see ATCs now onboarding and starting to treat faster than they were last year. So the ones that onboarded the second half of the year are treating faster. Our academic and community mix is starting to get more balanced, whereas at the beginning, we were mostly academic. Now we're going more into the community hospitals, getting closer to the patients, where the opportunity is greater for us.
好的。Reni,非常感謝你的提問。我先回答,然後交給 Friedrich。關於 ATC 網絡,我們看到 ATC 現在的導入(onboarding)以及開始治療的速度,比去年更快。因此在下半年導入的那些中心,開始治療的速度更快。我們的學術與社區中心的組合正變得更均衡;一開始我們主要是學術中心。現在我們更多進入社區醫院,更貼近病患,而那裡對我們而言機會更大。
So we do see that that is going to, over the year, mix more into a greater percentage of community entering in because we do have the key academics already on board and treating. In regard to sales force, we did increase our sales force going into this year based on the second half ATCs, entering into AMTAGVI authorization.
因此我們確實看到,隨著一年推進,組合會朝向更高比例的社區中心加入,因為關鍵的學術中心已經到位並開始治療。至於銷售團隊,我們在今年開始時就擴增了銷售人力,主要是基於下半年導入的 ATC,以及進入 AMTAGVI 授權流程。
We did see and have seen and are seeing increased demand from those ATCs. The new reps are being very impactful in the field with it, and we have a plan now to expand in Q2, as well as looking at later this year based on the timing and pace of both demand in our current ATCs and onboarding new ATCs. Hopefully, that answered your question.
我們確實看到、也一直看到、且正在看到來自這些 ATC 的需求增加。新加入的業務代表在第一線帶來了很大的成效;我們目前的計畫是在第二季擴編,同時也會視今年稍晚的時點與節奏而定,取決於現有 ATC 的需求以及新 ATC 導入的速度。希望這回答了你的問題。
Reni Benjamin - Analyst
Reni Benjamin - Analyst
Yeah.
有。
Daniel Kirby - Chief Commercial Officer
Daniel Kirby - Chief Commercial Officer
All right. Thank you very much, Reni. I'll hand over to Friedrich for the second half.
好的。非常感謝你,Reni。我把後半部分交給 Friedrich。
Friedrich Graf Finckenstein - Chief Medical Officer
Friedrich Graf Finckenstein - Chief Medical Officer
Thanks for the question, Reni. Yeah. So this is a really, really exciting result that we're seeing there. As you know, in endometrial cancer, the checkpoint inhibitors are and have moved into frontline therapy. So standard of care or really available therapy, if you want, in second line is dire. Usually, these patients are being treated with monotherapy chemotherapy, and response rates are usually below 10%, 15% highest, when you look at control arms of randomized trials.
謝謝你的問題,Reni。是的。我們看到的這個結果真的非常、非常令人振奮。如你所知,在子宮內膜癌中,免疫檢查點抑制劑已經、並且已經進入第一線治療。因此若你看第二線的標準治療,或說可用療法,其實非常匱乏。通常這些病人會接受單藥化療,而反應率通常低於 10%,最高也就 15%,當你看隨機試驗的對照組時就是如此。
So, that's not good enough. These patients have highly unmet medical needs, and seeing another immunotherapy come through with these response rates and typically durability that is differentiated from chemotherapy, that's really important. That's why we're planning on jumping on this and taking this further.
所以,這遠遠不夠。這些病人有高度未被滿足的醫療需求;看到另一種免疫療法以這樣的反應率、以及通常相較化療更具差異化的持久性(durability)出現,這非常重要。這也是為什麼我們計畫把握這個機會並進一步推進。
Reni Benjamin - Analyst
Reni Benjamin - Analyst
Thanks, guys, for taking the questions. Congrats.
謝謝各位讓我提問。恭喜。
Operator
Operator
Etzer Darout, Barclays.
Etzer Darout,Barclays。
Etzer Darout - Equity Analyst
Etzer Darout - Equity Analyst
Thanks for taking the question. Congrats on the quarter. Just looking again at your 2Q guide, just wondered how much of this rebound with the step up from the first quarter is maintenance disruption versus maybe underlying demand trends and what the key assumptions are behind the outlook there.
謝謝讓我提問。恭喜這一季的表現。再看一次你們第二季指引,我想了解第一季到第二季的回升、以及階梯式上升,有多少是維護造成的干擾所致,還是反映了潛在需求趨勢?以及該展望背後的關鍵假設是什麼?
And then maybe secondly on the pipeline, just as you think about the endometrial regulatory path, should we think about a potentially similar framework for -- as you're employing for sarcoma in terms of the regulatory path to accelerated approval?
然後第二點可能是關於研發管線,當你們思考子宮內膜癌的監管/法規路徑時,我們是否應該認為在加速核准的監管路徑上,可能會採用一個類似的框架——就像你們在肉瘤(sarcoma)方面所採用的那樣?
Frederick Vogt - Interim President, Interim Chief Executive Officer, General Counsel, Corporate Secretary
Frederick Vogt - Interim President, Interim Chief Executive Officer, General Counsel, Corporate Secretary
Yeah. So let me take the second question first, actually, because yes, correct. We are looking at a similar regulatory path for uterine serous carcinoma versus UPS and DDLPS, and we'll come back soon after we have some interactions with FDA. We're going to try to optimize as much as we possibly can supplemental BLA filings and possibly even combine stuff and work together to make sure that we can get these things approved as quickly as possible with the FDA. So stay tuned for a lot more detail on that.
是的。所以我先回答第二個問題,因為答案是肯定的,沒錯。我們正在針對子宮漿液性癌(uterine serous carcinoma)採取與 UPS 和 DDLPS 類似的監管路徑;在我們與 FDA 有一些互動之後,很快會再回來更新。我們會盡可能最佳化補充性 BLA(sBLA)申請,甚至可能把一些內容合併、協同推進,以確保能與 FDA 一起讓這些適應症盡快獲得核准。所以請持續關注,後續會有更多細節。
We're very excited obviously about all three indications. We think they all significantly add to AMTAGVI's potential, and we're currently built to launch all these indications quite quickly on the back of our commercial expertise and manufacturing expertise. On the Q2 guide, you were asking about maintenance versus demand. Demand trends are extremely strong, as Dan highlighted earlier.
我們對這三個適應症都非常興奮。我們認為它們都能顯著提升 AMTAGVI 的潛力,而我們目前也已具備條件,憑藉我們的商業化與製造專業,能相當快速地推動這些適應症的上市。至於你問到的第二季指引,是在問維護(maintenance)與需求(demand)之間的差異。如 Dan 先前強調的,需求趨勢非常強勁。
I really don't think about it as a maintenance issue. I think about it as something that we had to address, we fixed it's done. We won't talk about maintenance ever again. It's now built in our system, so we can do it without any kind of, any kind of impact whatsoever. Demand is very, very, very strong for the product right now.
我其實不把它視為維護問題。我把它視為我們必須處理的一件事——我們已經處理好了,事情結束了。我們不會再談什麼維護了。它現在已經內建在我們的系統裡,因此我們可以在不造成任何影響的情況下完成。目前這個產品的需求非常、非常、非常強。
Dan, would you want to emphasize again some of the points you made during the prepared remarks on demand trends?
Dan,你要不要再強調一下你在事先準備的發言中提到的、關於需求趨勢的一些重點?
Daniel Kirby - Chief Commercial Officer
Daniel Kirby - Chief Commercial Officer
Sure. We continue to see demand increase. This has happened through fourth quarter and first quarter and carried into second quarter. I mentioned before that March was our largest reported month to date. We continue to see a strong start to Q2, which is why we have the guidance set.
當然。我們持續看到需求增加。這個趨勢在第四季與第一季都發生,並延續到第二季。我之前提過,3 月是我們迄今為止回報過的最大單月。我們也持續看到第二季有一個強勁的開局,這也是我們設定該指引的原因。
Etzer Darout - Equity Analyst
Etzer Darout - Equity Analyst
Thank you.
謝謝。
Operator
Operator
Colleen Kusy, Baird.
接下來是 Baird 的 Colleen Kusy。
Unidentified Participant
Unidentified Participant
It's Nick on for Colleen. Thanks for taking the question. Congrats on the progress. So with the new guidance expecting $209 million in product sales in the back half of the year, can you just speak to your confidence in hitting that goal and what else needs to be done to get there?
我是代 Colleen 提問的 Nick。謝謝讓我提問。恭喜你們的進展。依照新的指引,下半年預期產品銷售為 2.09 億美元;你們能否談談對達成該目標的信心,以及還需要做哪些事情才能達到?
Frederick Vogt - Interim President, Interim Chief Executive Officer, General Counsel, Corporate Secretary
Frederick Vogt - Interim President, Interim Chief Executive Officer, General Counsel, Corporate Secretary
Yeah. So right now, Nick, we're highly confident we can achieve that. We've obviously already done a lot of it, and we have visibility right now in Q2 to essentially the entire quarter. That's why we're giving such strong guidance for Q2 AMTAGVI revenues as well as for PROLEUKIN.
好的。Nick,就目前而言,我們非常有信心可以達成。我們顯然已經完成了其中很大一部分,而且我們在第二季目前對幾乎整個季度都有能見度。這也是為什麼我們對第二季 AMTAGVI 營收以及 PROLEUKIN 都給出相當強勁的指引。
And then the back end of the year, we can see very clearly too. When you look at the guidance that we gave today, it's easily achievable with growth as we go from Q2 to Q3 to Q4 that we have line of sight and visibility to. We have a much better understanding of our ATCs and how they perform, how we can produce the product in every step of the process of getting AMTAGVI to a patient.
至於下半年,我們也看得非常清楚。你看我們今天給的指引,隨著我們從第二季到第三季再到第四季的成長,我們對其有明確的視線範圍與能見度,因此是很容易達成的。我們對 ATC(授權治療中心)有更深入的理解:它們的表現如何,以及在把 AMTAGVI 送到病患手上的每一個流程步驟中,我們如何生產產品。
And I think it's extremely responsible guidance that we've given, as guidance that we will do everything in our power to beat, of course. But it's guidance that we can stand by and live with, and it's quite strong compared to where we were last year.
我認為我們給出的指引非常負責任;當然,我們會盡一切努力去超越它。但這是一個我們可以支持、也能接受並承擔的指引,而且相較於去年我們所處的位置,這個指引相當強勁。
Daniel Kirby - Chief Commercial Officer
Daniel Kirby - Chief Commercial Officer
I would just add on to that, Nick, that this is our second full year on the market. We're over two years since launch. So variables such as seasonality, et cetera, we have a much better handle on, and we can project based on new ATCs coming and growth in the current ATCs, where demand is picking up and where demand continues to increase. And that's why we look at the second half of the year as being extremely strong.
Nick,我再補充一點:這是我們產品上市後的第二個完整年度。距離上市已超過兩年。因此像季節性等變數,我們掌握得更好,也能根據新 ATC 的加入與現有 ATC 的成長來做預測:需求在哪裡正在升溫、以及需求在哪裡持續增加。這也是為什麼我們認為下半年會非常強勁。
This starts right now at the fourth quarter. We're seeing it right now in the demand and what's lining up for the centers.
這個趨勢其實從現在、從第四季就開始了。我們現在就能從需求以及各中心排程/準備的情況中看到。
Unidentified Participant
Unidentified Participant
Great. Thank you.
很好。謝謝。
Operator
Operator
(Operator Instructions) Tyler Van Buren, TD Cowen.
(接線員指示)接下來是 TD Cowen 的 Tyler Van Buren。
Tyler Van Buren - Analyst
Tyler Van Buren - Analyst
Thanks very much for taking the question. Can you talk about the progress you made with the TILVANCE-301 enrollment? Where you are in terms of percent enrollment and what's been working to enroll patients, and what are some of the hurdles that you've had to overcome, like sites in the US using nivo and [ipili] in the frontline?
非常感謝讓我提問。你們能談談在 TILVANCE-301 收案(enrollment)方面取得的進展嗎?目前收案比例大概到哪裡、哪些做法對招募病患有效,以及你們需要克服的一些障礙是什麼——例如美國的一些試驗中心在一線治療使用 nivo 和 [ipili]?
Frederick Vogt - Interim President, Interim Chief Executive Officer, General Counsel, Corporate Secretary
Frederick Vogt - Interim President, Interim Chief Executive Officer, General Counsel, Corporate Secretary
Yeah. I can get that, and then maybe Friedrich can add a little bit to it too. We're seeing good enrollment in TILVANCE-301. Obviously, we do a lot of it outside the United States because it's easier outside the United States with standard of care. But it's a study that we think is well-designed. We have very good FDA feedback on the design of the study.
好的。我可以先回答,之後也許 Friedrich 也可以補充一些。我們在 TILVANCE-301 的收案表現不錯。顯然,我們有相當一部分是在美國以外進行,因為在美國以外依照標準治療(standard of care)會更容易一些。但我們認為這是一項設計良好的研究。我們也從 FDA 那裡得到對研究設計非常正面的回饋。
We're very focused on getting to the interim read where we can read ORR and have an early discussion with FDA about confirming AMTAGVI's approval as well as getting additional approval. You can go on clinicaltrials.gov and see the vast scope of sites that we're running right now. It's all over the place. There's --obviously, with any trial, there's things that you have to do to pound through it and succeed.
我們非常專注於推進到期中分析(interim read),屆時我們可以讀取 ORR(客觀緩解率),並與 FDA 及早討論:一方面確認 AMTAGVI 的核准,另一方面也爭取額外的核准。你可以到 clinicaltrials.gov 上查看我們目前運作中的試驗中心範圍,非常廣。遍布各地。當然——任何試驗都一樣,總會有一些事情需要你硬著頭皮把它推過去並取得成功。
Every company has to deal with this, and we're encountering and overcoming, I think, a lot of those right now with this trial. So we expect good things for TILVANCE, and we think that TIL therapy in the frontline setting, especially combined with pembrolizumab, can vastly improve the chances of a good overall survival outcome for patients. Our COM-202 1A data shows that. You've seen that publicly. We'll talk about that more this year. But that's really what's driving the study right now.
每家公司都必須面對這些問題,而我們目前在這項試驗中也正在遭遇並克服其中許多挑戰。因此我們對 TILVANCE 抱持正面期待;我們認為在一線治療情境中,TIL 療法,特別是與 pembrolizumab 聯合使用,能大幅提升病患獲得良好整體存活(overall survival)結果的機會。我們的 COM-202 1A 隊列數據顯示了這一點。你們已經在公開資訊中看過。我們今年會再多談一些。但這正是目前推動這項研究的核心原因。
Friedrich, do you want to add anything?
Friedrich,你要補充什麼嗎?
Friedrich Graf Finckenstein - Chief Medical Officer
Friedrich Graf Finckenstein - Chief Medical Officer
No, I think you've said it. I think it's important to remind folks that pembrolizumab is standard of care, and there are some geographic differences around this and not everyone believes that everyone should be getting frontline combination therapy. And then Fred, you already highlighted the data from cohort 1A from COM-202. That is proof for the potential for durable, meaningful benefits for patients in that treatment setting from TIL therapy when used that early. So I totally agree.
沒有,我覺得你已經說得很完整了。我認為重要的是提醒大家:pembrolizumab 是標準治療;在這方面存在一些地理區域差異,而且並不是所有人都認為每位病患都應該接受一線聯合治療。另外,Fred,你也已經提到 COM-202 的 1A 隊列數據。那證明了在那樣的治療情境中,若那麼早就使用 TIL 療法,對病患可能帶來持久且具臨床意義的效益。所以我完全同意。
Operator
Operator
Salim Syed, Mizuho.
Salim Syed,瑞穗。
Salim Syed - Analyst
Salim Syed - Analyst
Thanks for the question, guys. Would love to ask more than two questions here, but I'll limit myself. Corleen, Fred, maybe just one -- I'll limit myself to two here. On the ATM usage, this is now the fifth quarter you guys have access to ATM in a row. Four of the five quarters, it's been pretty heavy usage. Could you just outline for us just your financing plans here? I mean, this seems to be egregious at this point beyond any biotech company that I'm aware of how much you've accessed your ATM.
謝謝各位的提問。我很想在這裡問超過兩個問題,但我會克制一下。Corleen、Fred,或許就一個——我會把自己限制在兩個問題內。關於 ATM 的使用,這已經是你們連續第五個季度可以動用 ATM 了。五個季度中有四個季度的使用量都相當大。能否請你們為我們概述一下你們的融資計畫?我的意思是,就我所知,從你們動用 ATM 的程度來看,這在此時似乎已經超出任何一家生技公司,顯得相當誇張。
Why don't you just do a more traditional sort of financing path here? What are your financing plans going forward? Should we expect this continued sort of practice? And then the second on guidance, could you just outline for us, please. How do you come up with your guidance now? Like is it -- you have your sort of internal forecast and it's a plus minus when you get to that or is it just downside? Just how conservative is this guidance?
你們為什麼不採取更傳統的融資路徑?你們未來的融資計畫是什麼?我們是否應該預期這種做法會持續下去?第二個問題是關於財測指引,能否也請你們為我們概述一下。你們現在是如何制定指引的?例如——你們有內部預測,然後在此基礎上做上下浮動,還是只給下行區間?這個指引到底有多保守?
Frederick Vogt - Interim President, Interim Chief Executive Officer, General Counsel, Corporate Secretary
Frederick Vogt - Interim President, Interim Chief Executive Officer, General Counsel, Corporate Secretary
We don't think the ATM use is egregious at all. We dipped on the ATM occasionally, and we use it as needed to sort of top up where we are, and we've been really disciplined in how we use it. We're really driving the cash runway extension, and now we've pushed the cash runway out two quarters, more than two quarters in this most recent.
我們完全不認為使用 ATM 有任何誇張之處。我們只是偶爾動用 ATM,並在需要時用來補足我們的資金水位,而且我們在使用上一直非常自律。我們確實在推動現金跑道的延長,而在最近一次我們已將現金跑道延後了兩個季度以上。
By the way, every single quarter, we're pushing it out one quarter. So we're now all the way well into 2026, as you can see in the press release today. That's largely on the back of cost discipline. We're getting -- Internally, we're getting better and better at saving money when we run our trials, and we're obviously boosting margins, and we're making more revenue at the top line.
順帶一提,每一個季度我們都把它往後推一個季度。因此如你今天在新聞稿中所見,我們現在已經一路延伸到 2026 年的相當後段。這主要是成本紀律帶來的成果。在內部,我們在執行試驗時愈來愈擅長節省成本;同時我們也在提升毛利,並在營收端取得更高的成長。
Everything's coming together to really extend our runway. We are very, very focused on breakeven and ending dilution for the shareholders. So yes, we do have to make use of the ATM. We still explore non-dilutive options. We're still working on them right now, but we think the lowest cost of capital right now for the company is to do a little bit of equity here and there to make sure that we are getting closer and closer to that breakeven every quarter.
所有因素都在匯聚,真正延長我們的跑道。我們非常、非常專注於達到損益兩平並終止對股東的稀釋。所以,是的,我們確實必須動用 ATM。我們仍在探索非稀釋性的選項。我們現在仍在推進這些方案,但我們認為就目前而言,對公司來說最低的資金成本,是不時進行少量股權融資,以確保我們每個季度都更接近損益兩平。
On the guidance, we think this guidance is responsible. We are in possession, of course, of the company of detailed information about each ATC, the performance of each ATC, performance of our manufacturing, every aspect of what we do with AMTAGVI, much more detailed than we were when we launched the product in the beginning. Now we have all the information we need.
關於指引,我們認為這份指引是負責任的。當然,我們公司掌握每一家 ATC 的詳細資訊、各 ATC 的表現、我們製造端的表現,以及我們在 AMTAGVI 上所做的一切各個面向;相較於產品剛上市之初,我們現在掌握的細節多得多。現在我們已具備所需的全部資訊。
The AMTAGVI's team is doing a great job identifying all the trends. As we onboard new ATCs, we have a much better understanding of what they're going to add to the picture. We know which ATCs to focus our sales teams on and which ATCs can produce for us reliably, product that is, that is the highest quality that we can make very reliably for them.
AMTAGVI 團隊在辨識各種趨勢方面做得非常好。隨著我們導入新的 ATC,我們對它們將為整體帶來的貢獻有更好的理解。我們知道銷售團隊應該聚焦哪些 ATC,也知道哪些 ATC 能夠穩定地為我們產出——也就是產品——以我們能夠非常可靠地提供的最高品質產品。
And so we have internally, I would call them extremely sophisticated forecasts that we are watching every day to make sure that they are accurate, that the AMTAGVI's team watches. So for example, for Q2, practically every resection that we have for Q2 has already been performed. So we already have a very good understanding right now of what's going to happen for Q2. That's why we can give that guidance so tightly.
因此在內部,我會稱之為極其精密的預測模型;我們每天都在監看,以確保其準確性,AMTAGVI 團隊也會持續追蹤。例如就第二季而言,我們第二季幾乎每一例切除手術都已經完成。所以我們現在對第二季將會發生什麼有非常好的掌握。這就是為什麼我們能把指引給得這麼精準。
And we're really, really, really comfortable in that guidance. That's why we're giving it. We know investors want it. Like I said earlier, we're going to do our absolute best to beat it.
而且我們對這份指引非常、非常、非常有信心。所以我們才會給出它。我們知道投資人想要這個。就像我先前說的,我們會盡最大努力超越它。
Daniel Kirby - Chief Commercial Officer
Daniel Kirby - Chief Commercial Officer
I'll just add on to that, Fred. Looking at that, I agree the guidance, as we said, I've been here over one year, and really we've learned a lot about this market and how to forecast it and understanding it. As responsible as Fred said, but what I would also say that my teams are focused on beating that. That is our mission. That's what we're going to do, and our expectations are higher than that.
Fred,我再補充一下。就此而言,我同意這份指引——如我們所說,我來這裡已經一年多了,我們確實對這個市場、如何進行預測以及如何理解它學到了很多。如 Fred 所說,這是負責任的;但我也想說,我的團隊專注於超越這個目標。這就是我們的使命。這就是我們要做的事,而且我們的內部期望高於此。
Again, the guidance is responsible, what we believe we're going to do based on the current information we have. We will seek to onboard more ATCs than our goal. We'll seek to treat more patients than our goal. SO hopefully that gives you an idea of the mindset from my teams on that, but also too what we issue publicly is what we believe is responsible and what we are going to do based on the information we have today.
再次強調,這份指引是負責任的,是我們基於目前掌握的資訊所相信我們將能做到的。我們會努力導入比目標更多的 ATC。我們會努力治療比目標更多的病人。因此希望這能讓你了解我團隊在這方面的心態;同時,我們對外公開發布的內容,是我們認為負責任、且基於今天掌握的資訊我們將會做到的事情。
Salim Syed - Analyst
Salim Syed - Analyst
Okay. I appreciate the call, guys. Thank you.
好的。感謝這通電話,各位。謝謝。
Operator
Operator
Thank you. I am showing no further questions at this time. I would now like to turn it back to Frederick Vogt for closing remarks.
謝謝。我這邊顯示目前沒有其他提問。現在我想把時間交回給 Frederick Vogt 作結語。
Frederick Vogt - Interim President, Interim Chief Executive Officer, General Counsel, Corporate Secretary
Frederick Vogt - Interim President, Interim Chief Executive Officer, General Counsel, Corporate Secretary
Thank you again for joining the Iovance Biotherapeutics first-quarter 2026 conference call on the heels of record high demand for AMTAGVI, as well as significant progress across our pipeline. As we continue to work on therapies with curative potential in solid tumors, we are energized by the growing number of patient stories reflecting the impact of our cell therapies, some benefiting upwards of six years and counting. We remain deeply grateful to the patients, partners, healthcare professionals, and advocacy communities we serve.
再次感謝各位參加 Iovance Biotherapeutics 2026 年第一季法說會;在 AMTAGVI 需求創下歷史新高之際,我們的產品線也取得了顯著進展。在我們持續推進具治癒潛力的實體腫瘤療法之際,越來越多病患故事反映出我們細胞療法的影響力,部分病患受益已超過六年且仍在持續,這讓我們備受鼓舞。我們對我們所服務的病患、合作夥伴、醫療專業人士與倡議社群始終深懷感激。
Finally, I want to thank our exceptional Iovance team, our dedicated shareholders, and covering analysts for their continued support and commitment to our mission to innovate, develop, and deliver current and next generation cell therapies for patients with cancer. Thank you.
最後,我要感謝我們卓越的 Iovance 團隊、我們投入的股東,以及追蹤我們的分析師,持續支持並致力於我們的使命:為癌症病患創新、開發並交付現有與下一代細胞療法。謝謝。
Operator
Operator
This concludes today's conference call. Thank you for participating. You may now disconnect.
今天的電話會議到此結束。感謝各位參與。您現在可以掛線。