Galapagos NV (GLPG) 2026 Q1 法說會逐字稿

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  • Operator

    Operator

  • Good day, and thank you for standing by. Welcome to Galapagos's Q1 2026 financial results conference call. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Sherri Spear. Please go ahead.

    各位好,感謝您耐心等候。歡迎參加 Galapagos 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。現在我想把會議交給今天的講者 Sherri Spear。請開始。

  • Sherri Spear - Head of Investor Relations

    Sherri Spear - Head of Investor Relations

  • Hello again from Belgium. Thank you for joining us today as we report Galapagos's first quarter 2026 financial results and business update. Last evening, we issued a press release outlining these results. This release, along with today's presentation, can be found on the Galapagos investor website at www.glpg.com.

    再次從比利時向各位問好。感謝各位今天加入我們,一同聆聽 Galapagos 2026 年第一季財務業績與業務更新。昨晚我們發布了新聞稿,概述這些結果。該新聞稿以及今天的簡報可在 Galapagos 投資人網站 www.glpg.com 上查閱。

  • Before we begin, I would like to remind everyone that we will be making forward-looking statements. These forward-looking statements include remarks concerning future developments of our company and our pipeline and possible changes in the industry and competitive environment. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on information currently available to us and on assumptions we have made.

    在開始之前,我想提醒各位,我們將發表前瞻性陳述。這些前瞻性陳述包括關於本公司及我們研發管線未來發展的評論,以及產業與競爭環境可能的變化。這些前瞻性陳述反映我們目前對計畫、意圖、預期、策略與前景的看法,係基於我們目前可取得的資訊以及我們所作的假設。

  • Actual results may differ materially from those indicated by these statements and are accurate only as of the date of this recording, May 7, 2026. Galapagos is not under any obligation to update statements regarding the future or to conform to these statements in relation to actual results unless required by law.

    實際結果可能與這些陳述所示存在重大差異,且僅截至本錄音日期(2026 年 5 月 7 日)為準。除非法律要求,Galapagos 並無義務更新任何關於未來的陳述,或使這些陳述與實際結果相符。

  • You are cautioned not to place any undue reliance on these statements. Joining us on today's call from the executive team are Henry Gosebruch, Chief Executive Officer; and Aaron Cox, Chief Financial Officer. Eric Hedrick, Chief Clinical Adviser; Sooin Kwon, Chief Business Officer; and Dan Grossman, Chief Strategy Officer, will be joining us for the Q&A session. With all of that, let me now turn the call over to Henry Gosebruch, CEO. Henry?

    敬請各位勿過度依賴這些陳述。今天與會的管理團隊成員包括:執行長 Henry Gosebruch,以及財務長 Aaron Cox。臨床總顧問 Eric Hedrick、商務長 Sooin Kwon 與策略長 Dan Grossman 將在問答環節加入我們。說明至此,現在我把電話交給執行長 Henry Gosebruch。Henry?

  • Henry Gosebruch - Chief Executive Officer, Executive Director

    Henry Gosebruch - Chief Executive Officer, Executive Director

  • Thank you, Sherri, and thank you all for joining us today. It is truly an exciting time to be here. This call marks my one-year anniversary as CEO, and I couldn't be more proud of what we've accomplished together in the first year of our journey. We have transformed our management team and Board, repositioned our portfolio, added an exciting set of new pipeline programs, and we are changing our name to Lakefront Biotherapeutics.

    謝謝你,Sherri,也謝謝各位今天加入我們。能在此刻與各位相聚,確實令人振奮。這通電話會議是我擔任執行長滿一週年的時點,我對我們在旅程第一年共同完成的成果感到無比自豪。我們已重塑管理團隊與董事會、重新定位投資組合、加入一系列令人振奮的新研發管線計畫,並且我們將更名為 Lakefront Biotherapeutics。

  • This is not a story of small adjustments. It's a story of real transformation. A transformation like this requires the right people. At Galapagos, we've assembled a management team with world-class business development expertise and a shared mission of leveraging our unique position to develop new medicines for patients and to create significant value for our shareholders.

    這不是小幅調整的故事。這是一個真正轉型的故事。這樣的轉型需要合適的人才。在 Galapagos,我們組建了一支具備世界級商務拓展專業能力的管理團隊,並共同肩負使命:運用我們獨特的定位為病患開發新藥,並為股東創造顯著價值。

  • Our executives bring world-class deal making experience and each has an enviable track record. This is a team built for this new phase of our company. We are focused on disciplined decision-making, careful capital allocation, reshaping our pipeline through business development and focused execution that can create long-term sustainable value.

    我們的高階主管具備世界級的交易經驗,且每位都有令人稱羨的績效紀錄。這是一支為公司新階段而打造的團隊。我們專注於嚴謹的決策、審慎的資本配置,透過商務拓展重塑研發管線,並以聚焦的執行力創造長期且可持續的價值。

  • As Galapagos transforms, it's also important that the Board brings the right mix of capabilities and background. We are very pleased with the talented group that has joined us. The Board's expertise and background brings the skills and experience that are needed to provide effective oversight of our strategy and the company.

    隨著 Galapagos 轉型,董事會也必須具備適當的能力組合與背景同樣重要。我們對加入我們的優秀成員感到非常滿意。董事會的專業與背景帶來所需的技能與經驗,能有效監督我們的策略與公司運作。

  • Our previous Board Chair, Jerome Contamine, retired from the Board following the 2026 AGM, EGM. I am extraordinarily grateful for Jerome's service. He has been a great partner and provided valuable insights that have positioned us for this next phase of growth.

    我們前任董事長 Jerome Contamine 於 2026 年股東常會(AGM)與臨時股東會(EGM)後自董事會退休。我對 Jerome 的服務深表感謝。他一直是很棒的夥伴,並提供寶貴洞見,使我們得以為下一階段的成長做好定位。

  • I'm excited to work with Gino Santini as our new Board Chair going forward. Gino is a seasoned pharmaceutical professional with a 27-year career at Eli Lilly, where he served as Senior Vice President of Corporate Strategy and Business Development and led major acquisitions and partnerships. He has advised and directed numerous pharmaceutical, biotech and venture-backed organizations and has relevant experience in M&A, commercial partnerships and Board governance.

    展望未來,我很期待與新任董事長 Gino Santini 合作。Gino 是資深製藥專業人士,在禮來(Eli Lilly)擁有 27 年職涯,曾任企業策略與商務拓展資深副總裁,並主導多項重大併購與合作夥伴關係。他曾為眾多製藥、生技與創投支持的組織提供諮詢與指導,並在併購(M&A)、商業合作夥伴關係與董事會治理方面具備相關經驗。

  • Gino's extensive operational, strategic and business development expertise shaped by decades of global leadership in our sector will be invaluable as we execute on our strategy to deliver meaningful patient impact and sustainable shareholder returns.

    Gino 憑藉數十年在本產業的全球領導經驗所淬鍊出的深厚營運、策略與商務拓展專長,將在我們執行策略、為病患帶來有意義的影響並為股東創造可持續回報的過程中,發揮不可或缺的價值。

  • Just a few weeks ago, we announced that we had entered into a binding agreement with Gilead regarding the portfolio created by Ouro Medicines. This did not happen overnight. It was the result of a structured process, early relationship building, confidential reviews, negotiations and ultimately, successful agreement on a partnership with Gilead that has the potential to drive significant value for our shareholders.

    就在幾週前,我們宣布已就 Ouro Medicines 所建立的投資組合,與 Gilead 達成具約束力的協議。這並非一蹴可幾。這是結構化流程的成果,包括早期關係建立、保密審閱、談判,並最終成功就與 Gilead 的合作夥伴關係達成協議,該合作有潛力為股東帶來顯著價值。

  • The transaction centers on Ouro's lead program, gamgertamig, a BCMA, CD3 T cell engager for autoimmune diseases with multibillion-dollar revenue potential. Currently in Phase Ib dose-ranging studies and expected to enter registrational studies as early as 2027. Gamgertamig, Ouro's lead molecule is, in our view, a potential first and best-in-class T cell engager that has demonstrated a compelling profile in clinical studies.

    本次交易聚焦於 Ouro 的主力計畫 gamgertamig,這是一種針對 BCMA、CD3 的 T 細胞接合器(T cell engager),用於自體免疫疾病,具備數十億美元營收潛力。目前正處於第一期 Ib 劑量探索研究,預計最早可於 2027 年進入註冊性研究。在我們看來,gamgertamig 作為 Ouro 的主力分子,可能是一款潛在的同類首創且同類最佳的 T 細胞接合器,並已在臨床研究中展現令人信服的特徵。

  • The collaboration brings a meaningfully clinically differentiated high potential asset into our portfolio. The proof-of-concept initial indications are orphan indications where the clinical trials are manageable in size and scope with significant potential for expansion into additional indications.

    此次合作為我們的投資組合帶來一項在臨床上具明顯差異化、且高潛力的資產。概念驗證(proof-of-concept)的初始適應症為罕見疾病適應症,其臨床試驗在規模與範圍上較易管理,並具備向更多適應症擴展的重大潛力。

  • So far, we've seen compelling data from over 60 patients treated with gamgertamig across five distinct autoimmune indications. This clinical experience has highlighted the differentiated profile of gamgertamig characterized by rapid induction of durable complete responses, minimal cytokine release syndrome with the current schedule of administration and remarkable consistency in these findings across studies and disease indications.

    截至目前,我們已在五種不同的自體免疫適應症中,看到超過 60 名接受 gamgertamig 治療的病患所呈現的令人信服數據。這些臨床經驗凸顯 gamgertamig 的差異化特徵:可快速誘導且持久的完全反應、在目前給藥時程下細胞激素釋放症候群(CRS)極少,且上述發現於不同研究與疾病適應症間展現出高度一致性。

  • We look forward to sharing data with investors over the coming months in a series of publication and presentations at medical meetings. We believe that gamgertamig has a clear speed-to-market advantage. The initial focus on the treatment of rare autoimmune diseases has provided rapid proof of concept, enabling initiation of registrational trials as early as 2027. The program has also received Fast Track and Orphan drug designation in the US for ITP and AHA, further supporting an accelerated development path.

    未來幾個月,我們期待透過一系列出版與在醫學會議上的發表,與投資人分享相關數據。我們相信 gamgertamig 具備明確的加速上市優勢。初期聚焦於罕見自體免疫疾病治療,已快速完成概念驗證,使得最早可於 2027 年啟動註冊性試驗。該計畫亦已在美國針對 ITP 與 AHA 獲得快速通道(Fast Track)與孤兒藥資格認定,進一步支持加速開發路徑。

  • Finally, the spectrum of diseases that may be addressable by gamgertamig encompasses over 20 separate indications, giving us a pipeline and a product opportunity. In conclusion, we believe gamgertamig could represent a very important new type of treatment approach for immune reset therapy for patients across a large number of conditions.

    最後,gamgertamig 可能可涵蓋的疾病範圍包含超過 20 個不同適應症,為我們帶來研發管線與產品機會。總結而言,我們相信 gamgertamig 可能代表一種非常重要的新型治療方式,可作為免疫重置療法(immune reset therapy),惠及多種疾病狀況下的病患。

  • It has shown compelling clinical data so far, and it may have both a first-in-class advantage and best-in-class potential. Our partnership also includes three exciting preclinical programs, which we will look to progress with urgency. We look forward to sharing more about these programs in the future. Now I'll turn the call over to Aaron to talk about financials. Aaron?

    迄今為止,它已展現令人信服的臨床數據,並可能同時具備同類首創優勢與同類最佳潛力。我們的合作亦包含三項令人振奮的臨床前計畫,我們將力求以最快速度推進。未來我們也期待分享更多關於這些計畫的資訊。現在我把電話交給 Aaron,請他談談財務表現。Aaron?

  • Aaron Cox - Chief Financial Officer

    Aaron Cox - Chief Financial Officer

  • Thanks, Henry, and hello, everyone. As you heard from Henry, we are really excited about the Ouro transaction. Another major benefit is that it includes a partial waiver and modification of terms of our legacy Option License and Collaboration Agreement or OLCA, with Gilead, marking a meaningful step forward in our strategic and financial flexibility.

    謝謝你,Henry,大家好。正如你們從 Henry 那裡聽到的,我們對 Ouro 這筆交易感到非常振奮。另一項重大益處是,該交易包含對我們與 Gilead 之既有《選擇權授權與合作協議》(Option License and Collaboration Agreement,簡稱 OLCA)條款的部分豁免與修訂,這標誌著我們在策略與財務彈性方面邁出重要一步。

  • This slide details the benefits of this transaction relative to our legacy relationship. In short, the participation of Gilead was far above the $150 million expected with the Legacy Agreement. I'm really proud of our team for negotiating far better terms and proving that we are able to work together with Gilead to achieve our common goals.

    這張投影片詳述了相較於我們既有合作關係,此交易所帶來的益處。簡而言之,Gilead 的參與程度遠高於既有協議下原先預期的 1.5 億美元。我為我們團隊能談下更優渥的條款感到非常自豪,也證明我們能與 Gilead 攜手合作以達成共同目標。

  • As noted in our transaction announcement, under the revised terms and subject to the closing of the transaction, $500 million is now unlocked for broader use beyond the Ouro investment, enabling Galapagos to pursue new opportunities and transactions independently of Gilead and expanding the universe of potential strategic targets.

    如同我們在交易公告中所述,在修訂後的條款下,且以交易完成交割為前提,現有 5 億美元已解鎖,可用於 Ouro 投資以外更廣泛的用途,使 Galapagos 能夠在不依賴 Gilead 的情況下獨立追求新的機會與交易,並擴大潛在策略標的的範圍。

  • Additionally, up to $150 million of this $500 million may be used for return of capital to shareholders, subject to certain limitations, providing us with additional optionality to drive shareholder value. This partial waiver and modification to terms of the OLCA further strengthen our ability to deploy capital strategically and to pursue additional value-accretive opportunities. Along these lines, last week, we also received approval from our shareholders to complete a share repurchase. We will provide an update regarding a potential share repurchase following the close of the Ouro transaction.

    此外,在這 5 億美元中,最多可有 1.5 億美元用於向股東返還資本,但須遵守若干限制,為我們提供更多提升股東價值的選擇權。對 OLCA 條款的這項部分豁免與修訂,進一步強化了我們以策略方式部署資本並追求更多具增值性的機會之能力。在此方向上,上週我們也獲得股東核准以完成股份回購。我們將在 Ouro 交易完成交割後,就潛在的股份回購提供最新進展。

  • Turning now to our Q1 2026 financial results and as outlined in the press release issued last night. Our total net revenues were EUR6.5 million compared to EUR75 million in Q1 2025. This decrease is mainly driven by the prior year comparison, which included EUR57.6 million related to the OLCA revenue recognition. As noted with our full year 2025 results, the remaining deferred income balance related to the OLCA was fully released at year-end 2025.

    接下來談我們 2026 年第一季的財務結果,如同昨晚發布的新聞稿所述。我們的淨營收總額為 650 萬歐元,較 2025 年第一季的 7,500 萬歐元下降。此下降主要源於去年同期比較基期,當時包含與 OLCA 收入認列相關的 5,760 萬歐元。如同我們在 2025 全年業績中所提及,與 OLCA 相關的剩餘遞延收入餘額已於 2025 年底全數轉回認列。

  • In Q1 2026, revenues were primarily driven by EUR4.9 million in supply revenues from Jyseleca inventory sales to Alfasigma and EUR1.6 million in collaboration revenues, reflecting royalties from Gilead. On the cost side, we continue to see significant reduction in our operating expenses. R&D expenses decreased to EUR31 million, contributing to an overall improvement in our cost base. This reduction is driven by lower severance expenses as well as the absence of restructuring-related charges that impacted Q1 2025.

    在 2026 年第一季,營收主要來自 490 萬歐元的供應收入(向 Alfasigma 銷售 Jyseleca 庫存)以及 160 萬歐元的合作收入(反映來自 Gilead 的權利金)。在成本方面,我們持續看到營運費用顯著下降。研發費用降至 3,100 萬歐元,促成我們整體成本結構的改善。此降幅主要由較低的資遣費用,以及 2025 年第一季所受重組相關費用影響在本期不再發生所致。

  • As a result, operating loss improved to EUR63.7 million compared to EUR158.7 million last year, which included EUR111 million in restructuring costs. Moving below operating income, we reported net financial income of EUR77.7 million, mainly driven by positive fair value adjustments and favorable unrealized currency exchange gains on our US dollar-denominated cash and investments of EUR64.3 million.

    因此,營業虧損改善至 6,370 萬歐元,較去年同期的 1.587 億歐元為佳;去年同期包含 1.11 億歐元的重組成本。在營業利益以下,我們認列淨財務收益 7,770 萬歐元,主要由正向的公允價值調整,以及以美元計價之現金與投資所產生的有利未實現匯兌收益 6,430 萬歐元所帶動。

  • This led to a net profit of EUR14.5 million for the quarter compared to a net loss of EUR153.4 million for the first three months of 2025. Financial investments and cash and cash equivalents totaled EUR2,982.2 million on March 31, 2026, as compared to EUR3,297 million on March 31, 2025. The quarter end cash balance meaningfully benefited from a decrease in the US dollar to euro exchange rate, which moved from $1.175 at year-end 2025 to approximately $1.15 at the end of the quarter.

    因此,本季淨利為 1,450 萬歐元,相較之下,2025 年前三個月為淨損 1.534 億歐元。截至 2026 年 3 月 31 日,金融投資以及現金與約當現金合計為 29.822 億歐元,相較於 2025 年 3 月 31 日的 32.97 億歐元。季末現金餘額亦明顯受惠於美元兌歐元匯率下滑,匯率由 2025 年底的 1.175 美元降至季末約 1.15 美元。

  • Turning now to our guidance for 2026. With the closing of the Ouro transaction expected in the second quarter, we expect to spend EUR60 million to EUR75 million on Ouro-related cash expenditures, including operating costs and transaction expenses in 2026. Along with the upfront payment of approximately EUR713 million, this results in total Ouro related cash expenditures of EUR775 million to EUR790 million for 2026.

    接下來談我們對 2026 年的指引。由於預期 Ouro 交易將於第二季完成交割,我們預計 2026 年將支出 6,000 萬至 7,500 萬歐元的 Ouro 相關現金支出,包括營運成本與交易費用。連同約 7.13 億歐元的預付款,2026 年 Ouro 相關現金支出總額將為 7.75 億至 7.90 億歐元。

  • We continue to expect onetime cash costs of EUR125 million to EUR175 million related to the wind down of cell therapy activities. Inclusive of the Ouro-related expenditures and continued wind-down of cell therapy, we now expect to end the year with EUR1.975 billion to EUR2.05 billion of cash and cash equivalents. Importantly, the company remains robustly funded.

    我們仍預期與細胞治療業務收尾相關的一次性現金成本為 1.25 億至 1.75 億歐元。納入 Ouro 相關支出以及持續進行的細胞治療收尾後,我們目前預期年底現金與約當現金將為 19.75 億至 20.5 億歐元。重要的是,公司資金仍相當充裕。

  • Following this transaction and including estimated R&D spend associated with gamgertamig until first approval, the company will continue to have a majority of its current cash remaining for additional strategic transactions and other capital allocation priorities. Now let me turn it back to Henry to wrap up.

    在完成此交易後,並納入與 gamgertamig 直至首次核准前相關的估計研發支出,公司仍將保有目前現金的大部分,可用於其他策略性交易及其他資本配置優先事項。接下來我把時間交還給 Henry 作結。

  • Henry Gosebruch - Chief Executive Officer, Executive Director

    Henry Gosebruch - Chief Executive Officer, Executive Director

  • Thank you, Aaron. In closing, I'm just thrilled to introduce you to the new Lakefront Biotherapeutics. To us, Lakefront symbolizes the attractive opportunity in front of us and the new beginning we are creating. My most reflective moments often occur when I'm out exercising on Chicago's Lakefront.

    謝謝你,Aaron。最後,我非常高興向各位介紹全新的 Lakefront Biotherapeutics。對我們而言,Lakefront 象徵著眼前極具吸引力的機會,以及我們正在開創的新起點。我最常沉思的時刻,往往是在芝加哥湖濱運動時。

  • Our new name captures what we aspire to achieve for patients, enhanced quality of life, meaningful positive impact and more time for what matters most. It represents helping patients move toward a better future with greater hope and possibility. As of tomorrow, May 8, we expect to be listed as LKFT on Euronext and NASDAQ, symbolizing another pivotal step in our transformation. So with that, thank you all for your attention, and we will now open it up for your questions. Operator?

    我們的新名稱體現了我們希望為病患達成的目標:提升生活品質、帶來有意義的正向影響,並讓他們有更多時間投入最重要的事。它代表著協助病患以更大的希望與可能性邁向更好的未來。自明天 5 月 8 日起,我們預期將以 LKFT 之代號在 Euronext 與 NASDAQ 掛牌,象徵我們轉型歷程中的另一個關鍵里程碑。因此,感謝各位的關注,我們現在開放提問。接線員?

  • Operator

    Operator

  • (Operator Instructions)

    (接線員指示)

  • Brian Abrahams, RBC Capital Markets.

    Brian Abrahams,RBC 資本市場。

  • Brian Abrahams - Managing Director

    Brian Abrahams - Managing Director

  • Congrats on all the transformation over there. I was wondering if you could give us maybe your latest thoughts on what the dose-ranging gamgertamig data will need to show specifically just in terms of B-cell depletion, depth and durability, CRS rate reductions to move forward in registrational, how you're going to be picking which registrational trials to begin first? And just any more thoughts on the potential size and complexity of these trials that could start next year?

    恭喜你們在那邊完成了整體轉型。我想請教你們是否能分享一下你們對 gamgertamig 劑量範圍(dose-ranging)數據最新的看法:具體而言,在 B 細胞耗竭的程度與持久性、CRS 發生率降低方面,數據需要呈現哪些結果,才能推進到註冊性(registrational)階段?你們將如何決定先啟動哪些註冊性試驗?另外,對於可能在明年啟動的這些試驗,其規模與複雜度,你們是否還有更多想法?

  • Henry Gosebruch - Chief Executive Officer, Executive Director

    Henry Gosebruch - Chief Executive Officer, Executive Director

  • Brian, it's Henry. Thanks for the question. I'll start, and then I'll have Eric supplement. So first of all, look, we -- as we said on the prior discussion, we had a chance to really thoroughly diligence not only gamgertamig, but other programs out there with other T cell engagers. And we've seen really compelling data from over 60 patients that showed very rapid onset, very deep depletion and very good durability.

    Brian,我是 Henry。謝謝你的問題。我先回答,之後請 Eric 補充。首先,如同我們在先前的討論中所說,我們有機會非常徹底地盡職調查,不僅是 gamgertamig,也包括其他採用 T 細胞接合劑(T cell engagers)的外部專案。我們已從超過 60 位病患的數據中看到非常具說服力的結果:起效非常迅速、耗竭非常深,且持久性非常好。

  • And so again, as we've talked about, that will come out here in the next couple of quarters in terms of individual releases at medical meetings and other publications. So just for context. But I'll let Eric go through the specifics on the 3 points you raised. Eric?

    因此,如同我們先前談到的,接下來幾個季度,相關內容將會在醫學會議的個別發表以及其他出版物中陸續揭露。以上先提供背景。至於你提出的三個重點,我讓 Eric 來說明細節。Eric?

  • Eric Hedrick - Head of Oncology Evaluatio

    Eric Hedrick - Head of Oncology Evaluatio

  • Yes. Thanks, Henry. Brian, thanks for the question. Sort of expanding on what Henry just said, I think the team at Ouro has done really good work on exploring dose ranging here. I would say that the profile that would be an optimal profile for going into late-stage development would be one where you get profound B cell depletion, but a dose duration schedule that minimizes CRS risk.

    是的。謝謝你,Henry。Brian,謝謝你的提問。延伸Henry剛才所說的,我認為Ouro團隊在探索此處的劑量範圍方面做得非常出色。我會說,進入後期開發的最佳特徵,應該是在達到深度B細胞耗竭的同時,採用能將CRS風險降到最低的給藥劑量與療程長度安排。

  • And I think at the current dose and schedule, we referred to this previously, it really does seem like alterations in the dose and the duration of therapy can really minimize the CRS risk. I think the other aspect here that's important will be having a dose that results in a period of B-cell depletion that is deep, but relatively short, right, so that you can minimize the infectious risk, the need for supplemental intravenous immunoglobulin. And again, I think the team at Ouro is well on your way to identifying that dose. And we fully expect that by 2027, we'll be comfortable with the doses that we take forward into Phase III programs.

    而且我認為在目前的劑量與給藥時程下——我們先前也提過——調整劑量與治療持續時間,確實看起來能大幅降低CRS風險。我認為另一個重要面向,是要有一個劑量能帶來一段深度但相對較短的B細胞耗竭期,對吧,如此才能把感染風險、以及補充靜脈注射免疫球蛋白的需求降到最低。再一次,我認為Ouro團隊正朝著找出該劑量的方向穩步前進。我們完全預期到2027年時,我們會對推進至第三期計畫的劑量感到有把握。

  • Operator

    Operator

  • Judah Frommer, Morgan Stanley.

    Judah Frommer,摩根士丹利。

  • Judah Frommer - Analyst

    Judah Frommer - Analyst

  • I think we saw another transaction recently for BCMA, CD3. There are several assets in the space. Just curious how you think the space might evolve and how you're thinking about development plans. Do you see room for multiple assets targeting the same mechanism within the same large indications? Or do you think this is going to be an area where various assets are going to kind of carve up sub indications, maybe stick to smaller indications as opposed to necessarily all going after the same large ones?

    我想我們最近也看到另一筆針對BCMA、CD3的交易。這個領域裡有好幾個資產。我只是好奇你們認為這個領域可能會如何演變,以及你們如何思考開發計畫。你們是否認為在相同的大型適應症中,會有空間容納多個針對相同機制的資產?或者你們認為這會是一個各種資產會去切分次適應症、也許更聚焦於較小適應症,而不是一定都去追逐相同大型適應症的領域?

  • Henry Gosebruch - Chief Executive Officer, Executive Director

    Henry Gosebruch - Chief Executive Officer, Executive Director

  • Yes. Thanks, Judah. It's Henry. So again, just for context, we were able to diligence multiple opportunities in some depth, and we're quite pleased that our top choice, i.e., gamgertamig was the one that we were ultimately able to transact with. So we continue to believe that gamgertamig is the best alternative out there and has the potential to be first-in-class.

    是的。謝謝你,Judah。我是Henry。再補充一下背景,我們曾對多個機會做過相當深入的盡職調查,而我們很高興最終能完成交易的是我們的首選,也就是gamgertamig。因此我們仍然相信,gamgertamig是目前最好的替代方案,並且有潛力成為同類首創(first-in-class)。

  • That being said, look, we're very encouraged by the fact that we're not the only ones excited about the space that there's a lot of investment going into it. I think that is good to see and ultimately good for patients. The Ouro team has been really, really savvy in terms of picking very interesting indications that we believe are quite sizable, multibillion-dollar potential easily, but where they have a clear timing advantage.

    話雖如此,我們也很受鼓舞,因為對這個領域感到興奮的不只我們,還有大量投資正在投入其中。我認為看到這點很好,最終也有利於病患。Ouro團隊在選擇適應症方面非常、非常精明:他們挑選了我們認為規模相當可觀、很容易就有數十億美元潛力的適應症,同時又具備明確的時程優勢。

  • And so I think in those places, we're in a really favorable position. That being said, we don't view gamgertamig behind in any other indication as well, and those are being very actively explored. To your question whether ultimately the best drug takes all of it or the market gets split up in some way, I think we'll defer that when we go a little bit further. But again, we're -- based on our diligence of multiple programs, we think we got the first and best-in-class alternative here with us.

    因此在那些領域,我們處於非常有利的位置。話雖如此,我們也不認為gamgertamig在其他適應症上落後,而那些也正在非常積極地探索中。至於你問到最終是否會由最佳藥物通吃,或市場會以某種方式被分割,我想我們會等到再往前推進一些再回答。但再次強調,基於我們對多個計畫的盡職調查,我們認為我們拿到的是同類首個且最佳(first- and best-in-class)的選擇。

  • Operator

    Operator

  • Phil Nadeau, TD Cowen.

    Phil Nadeau,TD Cowen。

  • Philip Nadeau - Analyst

    Philip Nadeau - Analyst

  • Congrats on the progress. Two from us. So first on gamgertamig, you've mentioned that it's perhaps best-in-class. Can you go into a little bit more detail about how it is differentiated structurally or otherwise from the other BCMA, CD3s? That's first. And then a follow-on to Brian's question. In terms of moving into pivotal development, can you talk about the framework with which you're evaluating the different indications and opportunities and how you prioritize the first one or several to move forward into pivotal development?

    恭喜進展。我們有兩個問題。首先關於gamgertamig,你們提到它可能是同類最佳(best-in-class)。你們能否更詳細說明,它在結構或其他方面,與其他BCMA、CD3產品相比有何差異化?這是第一個。接著延續Brian的問題。在邁向關鍵性(pivotal)開發方面,你們能否談談你們用來評估不同適應症與機會的框架,以及你們如何優先排序,決定第一個或前幾個要推進到關鍵性開發的項目?

  • Henry Gosebruch - Chief Executive Officer, Executive Director

    Henry Gosebruch - Chief Executive Officer, Executive Director

  • Eric, why don't you take the first one and then perhaps Dan can take the second one.

    Eric,你先回答第一個,然後也許Dan可以回答第二個。

  • Eric Hedrick - Head of Oncology Evaluatio

    Eric Hedrick - Head of Oncology Evaluatio

  • Yes, sure. Phil, thanks for your question. Yes, I think in terms of differentiation amongst these BCMA-directed T-cell engagers, yes, one of the things that was attractive about the Ouro molecule, I guess there was two aspects. One is the detuning of the CD3 binding arm, which we think goes a long way in addition to dosing and significantly reducing the CRS risk.

    好的,當然。Phil,謝謝你的提問。是的,談到這些以BCMA為標的的T細胞接合器之間的差異化,我想Ouro分子吸引人的地方大概有兩個面向。第一是對CD3結合臂進行「去調諧」(detuning),我們認為這一點再加上劑量設計,能在很大程度上顯著降低CRS風險。

  • So that was important. The BCMA binding arm is very potent, right? And so we're comfortable that, that from the data we've seen so far is sort of resulting in very deep B-cell depletion and the sort of response in disease that you would associate with profound B-cell depletion.

    所以那點很重要。BCMA結合臂非常強效,對吧?因此我們有信心,從目前看到的數據來看,這會帶來非常深度的B細胞耗竭,以及你會與深度B細胞耗竭相關聯的疾病反應。

  • So I think those were the main aspects of the molecule that were attractive to us. And again, the Ouro team has really advanced us very well in the clinic. And I think you're seeing the clinical representations for those molecular features. And maybe, Dan, if you want to comment as well.

    所以我認為這些是該分子對我們而言最具吸引力的主要面向。而且再次強調,Ouro團隊在臨床上確實把我們推進得很好。我想你們也看到了這些分子特徵在臨床上的呈現。Dan,如果你也想補充評論的話。

  • Dan Grossman - Chief Strategy Officer

    Dan Grossman - Chief Strategy Officer

  • Yes. Sure. I'm happy to talk about indication selection. And first, I'll echo what Henry said in terms of appreciation for the Ouro team's strategic judgment in choosing initial indications in which you could get a very rapid and very clear signal of the actual clinical potency of the molecule and particularly in the benign hematologic indications.

    是的。當然。我很樂意談談適應症選擇。首先,我也呼應Henry所說的:我們很感謝Ouro團隊在策略判斷上的能力,他們選擇了初始適應症,使得你能非常快速且非常清楚地看到該分子實際臨床效力的訊號,特別是在良性血液學適應症上。

  • Beyond that, I mean, we kind of see gamgertamig as a vanguard of T cell engager therapy for autoimmune disease broadly, it's going to really be revolutionary over the next 10 years. We anticipate that there's a high likelihood that in 10 years, it will be hard to imagine there was a time when this was not -- this kind of technology was not part of standard of care across these B-cell mediated autoimmune disease.

    除此之外,我們某種程度上把gamgertamig視為廣泛自體免疫疾病領域T細胞接合器療法的先鋒(vanguard);未來10年它將會非常具有革命性。我們預期,很有可能在10年後,人們會很難想像曾經有一段時間——這類技術並不是這些由B細胞介導的自體免疫疾病之標準治療(standard of care)的一部分。

  • And so we are really looking for quite a bit of breadth and to get the product out into the clinic and then into the hands of physicians to see what it can do across not just different diseases, but different therapeutic areas. So of course, the first filter is always going to be a mechanistic hypothesis that deep B-cell depletion will result in meaningful clinical benefit to patients.

    因此我們確實在尋求相當大的廣度,讓產品進入臨床,並交到醫師手中,看看它不僅在不同疾病之間,甚至在不同治療領域中能做到什麼。所以當然,第一道篩選永遠會是機制假說:深度B細胞耗竭將為病患帶來有意義的臨床效益。

  • That's sort of effectively a proxy for PTRF. And then within that, we see a range of disease states in which the -- in which the standard of care today and anticipated over the next couple of years is woefully inadequate.

    這在某種程度上可有效作為PTRF的替代指標(proxy)。而在此之內,我們看到一系列疾病狀態——在這些狀態下,現今的標準治療,以及未來幾年可預期的標準治療,都嚴重不足。

  • So there's the room to the most good for patients where there are material sized patient populations and where the feasibility of running clinical trials and bringing the product to the commercial market is most feasible. So we're going to be balancing those factors, but really looking to show the broad potential of this kind of technology.

    因此,在那些能為病患帶來最大改善空間、且病患族群規模可觀、並且最可行去執行臨床試驗與將產品推向商業市場的領域,我們會優先考量。所以我們會在這些因素之間取得平衡,但核心仍是要展現這類技術的廣泛潛力。

  • Henry Gosebruch - Chief Executive Officer, Executive Director

    Henry Gosebruch - Chief Executive Officer, Executive Director

  • Yes. And Phil, it's Henry. Just to add to Dan's answer. One thing that, again, really attracted us in our diligence is that given how profound the impact is on patients that we've been able to see, you really need just pretty small numbers of patients in these diseases to really figure out whether you get the right dosing scheme to take it forward into larger studies.

    是的。Phil,我是Henry。補充一下Dan的回答。我們在盡職調查中再次被吸引的一點是,鑑於我們所看到對患者影響之深遠,在這些疾病中其實只需要相當少量的患者數,就能真正判斷是否找到了正確的給藥方案,進而推進到更大型的研究。

  • So we quite like the fact that this is very capital efficient. Again, in due time, we'll provide a little bit more on sort of our R&D spend, et cetera. Aaron gave it for this year, of course. But that's another very important feature that there's really relatively modestly sized studies needed and then you can go into pivotal, which are also quite modest given, again, this profound impact on patients we've seen.

    因此我們很喜歡這一點,因為資本效率非常高。同樣地,適當時機我們會再多提供一些關於我們研發支出等方面的資訊。Aaron當然已經提供了今年的數字。但另一個非常重要的特點是,確實只需要相對規模不大的研究,接著就能進入關鍵性試驗;而關鍵性試驗的規模也相當適中,因為同樣地,我們看到對患者有如此深遠的影響。

  • Dan Grossman - Chief Strategy Officer

    Dan Grossman - Chief Strategy Officer

  • We can do a lot with a little at this effect size.

    在這樣的效應量下,我們可以用很少的資源做很多事。

  • Operator

    Operator

  • Sean McCutcheon, Raymond James.

    Sean McCutcheon,Raymond James。

  • Unidentified Participant

    Unidentified Participant

  • This is [Yang], on for Sean. I have two questions. Maybe the first one is, could you speak to the optionality on continued BD activities and the prioritization, for instance, targets or indications driven that may have a clear strategy to have a synergism with gamgertamig in autoimmune disease? And I have a follow-up.

    我是[Yang],代Sean提問。我有兩個問題。第一個可能是:能否談談持續BD活動的選擇性(optionalitiy)以及優先順序,例如由標的或適應症驅動、且在自體免疫疾病上可能與gamgertamig具有協同效應的明確策略?我還有一個追問。

  • Henry Gosebruch - Chief Executive Officer, Executive Director

    Henry Gosebruch - Chief Executive Officer, Executive Director

  • It's Henry. So a couple of things. Again, we've said that the majority of our capital is available for other strategic initiatives and future BD. Aaron walked through the $500 million bucket we now have that we can do deals independent from Gilead and we can take a portion of that for return of capital as well. So we're very excited about that flexibility and the substantial capital we have left to look for other BD.

    我是Henry。有幾點。同樣地,我們已經說過,我們的大部分資金可用於其他策略性計畫與未來的BD。Aaron也說明了我們現在有5億美元的資金池,可以在不依賴Gilead的情況下進行交易;我們也可以從中撥出一部分用於資本回饋。因此我們對這種彈性以及仍然保有的充足資金、用來尋找其他BD機會感到非常振奮。

  • That being said, we're very excited about Ouro and the potential that we just in the prior question outlined and the three preclinical assets we have that could also be meaningful opportunities. So I would say the hurdle for the next BD deal is very, very high. The hurdle for the first one was also high, but the next one is very, very high because we've got a really, really nice portfolio.

    話雖如此,我們對Ouro以及其潛力感到非常興奮,這點我們在上一個問題中已經概述;此外我們還有三個臨床前資產,也可能是很有意義的機會。所以我會說,下一筆BD交易的門檻非常、非常高。第一筆的門檻也很高,但下一筆會更高,因為我們已經擁有一個非常、非常好的產品組合。

  • We do have increased capability now, and we, of course, have a set of diseases that it could make sense to build on, as you say, to introduce some development or even commercial synergy down the road. But I think the message right now is, look, we're excited about what we have. We're going to be very, very busy executing these programs, and we're in no rush to do a second BD deal here given how much have.

    我們現在的能力也有所提升,當然也有一組疾病領域,正如你所說,可能有意義在其上延伸,未來引入一些開發端甚至商業端的協同效應。但我認為目前的訊息是:我們對現有的資產感到興奮。我們會非常、非常忙於執行這些計畫;而且考量到我們手上已有這麼多,我們並不急著在此時做第二筆BD交易。

  • Unidentified Participant

    Unidentified Participant

  • Great. Could you also please comment on the infection risk, hematology events associated with gamgertamig and all the BCMA-TCE class in general and the company's view on the differences it may be associated with CD19 TCE for autoimmune disease.

    很好。也請你們評論一下:與gamgertamig以及整個BCMA-TCE類別相關的感染風險、血液學事件;以及公司如何看待其與用於自體免疫疾病的CD19 TCE之間可能存在的差異。

  • Henry Gosebruch - Chief Executive Officer, Executive Director

    Henry Gosebruch - Chief Executive Officer, Executive Director

  • Eric, why don't you take that one?

    Eric,你來回答這題如何?

  • Eric Hedrick - Head of Oncology Evaluatio

    Eric Hedrick - Head of Oncology Evaluatio

  • Yes. Yes. Thanks for the question. I would say that sort of in relation to the comment I made previously, the infectious risk here really has to do with the duration of B-cell depletion and plasma cell depletion, right? When we're giving -- when team at Ouro was giving this drug in the current dosing schedule, we're comfortable that we're getting to the point where the period of B-cell depletion will be such that the infectious risk should be manageable.

    好的。好的。謝謝你的問題。我會說,這裡的感染風險其實與我先前的評論相關,主要取決於B細胞耗竭與漿細胞耗竭的持續時間,對吧?在目前的給藥時程下,當Ouro團隊給予這個藥物時,我們有信心能達到一個程度,使B細胞耗竭的期間足以讓感染風險維持在可管理的範圍內。

  • So that will be a key point in sort of determining the dose to go forward. But again, I think the key point is that you can dose this drug in such a way that you can have an impact on the period of B-cell depletion and then the infectious risks should really go along with the durability of B-cell depletion. And again, the team at Ouro has done a really nice job at dose ranging and trying to like optimize that period.

    因此,這會是決定後續推進劑量的一個關鍵點。但同樣地,我認為重點在於:你可以用某種方式給藥,去影響B細胞耗竭的期間,而感染風險確實會隨著B細胞耗竭的持久性而變化。同樣地,Ouro團隊在劑量範圍探索方面做得非常好,並嘗試優化那段期間。

  • Operator

    Operator

  • (inaudible), KBCS.

    (聽不清),KBCS。

  • Mathias Goeminne - Analyst

    Mathias Goeminne - Analyst

  • Mathias coming in for Jacob. I had a question on the Galapagos 3667 program. What are the strategic options you're currently considering? And could one of the potential outcomes be that you choose to develop the program in collaboration with Gilead? Or how do you look at that program at the moment?

    我是Mathias,代Jacob提問。我想問Galapagos 3667計畫。你們目前正在考慮哪些策略選項?其中一個可能的結果會不會是選擇與Gilead合作開發該計畫?或者你們目前如何看待這個計畫?

  • Henry Gosebruch - Chief Executive Officer, Executive Director

    Henry Gosebruch - Chief Executive Officer, Executive Director

  • Yes. Thanks for the question. It's Henry. As we said previously, we're analyzing various alternatives relating to '3667. That process continues, although it's quite well advanced at this point. So we're coming close to the end of that process and making a decision which way to go, and we're assessing kind of a broad range of options. So more to come on that in the not-too-distant future, but it's inappropriate at this point to comment further on it.

    是的。謝謝你的問題。我是Henry。如同我們先前所說,我們正在分析與「3667」相關的各種替代方案。這個流程仍在進行中,雖然目前已相當接近完成。因此我們快要走到流程尾聲,並將做出決定要採取哪一條路;我們正在評估相當廣泛的一系列選項。不久的將來會有更多資訊,但在此時進一步評論並不適當。

  • Operator

    Operator

  • I would now like to turn the conference back to Henry Gosebruch for closing remarks.

    我現在想把電話會議交回Henry Gosebruch作結語。

  • Henry Gosebruch - Chief Executive Officer, Executive Director

    Henry Gosebruch - Chief Executive Officer, Executive Director

  • Very good. Well, thank you for your time today. We look forward to closing the Ouro transaction here in the second quarter and welcoming the team from Ouro to join us here. But more broadly, reflecting on the last year, it's really been a fantastic year, and I'm super proud of what we've accomplished together. But I'm also super excited about the year ahead for Lakefront Bio. So thank you, and we hope you have a great day.

    非常好。感謝各位今天撥冗參與。我們期待在第二季完成Ouro交易,並歡迎Ouro團隊加入我們。更廣泛地回顧過去一年,這確實是非常精彩的一年,我也為我們共同完成的成果感到非常自豪。同時,我也對Lakefront Bio接下來的一年感到非常興奮。謝謝各位,祝大家有美好的一天。

  • 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。