Coherus Oncology Inc (CHRS) 2025 Q4 法說會逐字稿

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  • Operator

    Operator

  • Good day, and thank you for standing by. Welcome to the Q4 and full year 2025 Coherus Oncology, Inc earnings conference call. (Operator Instructions) Please be advised that today's conference is being recorded.

    各位好,感謝您耐心等候。歡迎參加 Coherus Oncology, Inc 2025 年第四季及全年財報電話會議。(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, Carrie Graham. Please go ahead.

    現在我想把會議交給今天的講者 Carrie Graham。請開始。

  • Carrie Graham - Vice President, Investor Relations and Advocacy

    Carrie Graham - Vice President, Investor Relations and Advocacy

  • Thank you, Heidi. Good afternoon, and welcome to Coherus Oncology's fourth-quarter and 2025 year-end earnings conference call. Joining me today to discuss our results are Denny Lanfear, Chief Executive Officer of Coherus; Dr. Theresa Lavallee, Chief Scientific and Development Officer; Dr. Rosh Dias, Chief Medical Officer; Sameer Goregaoker, Chief Commercial Officer; and Bryan McMichael, Chief Financial Officer.

    謝謝你,Heidi。各位下午好,歡迎參加 Coherus Oncology 2025 年第四季及全年年終財報電話會議。今天與我一同討論公司業績的有:Coherus 執行長 Denny Lanfear;首席科學與研發長 Theresa Lavallee 博士;首席醫療長 Rosh Dias 博士;首席商務長 Sameer Goregaoker;以及首席財務長 Bryan McMichael。

  • Before we get started, I would like to remind you that today's call includes forward-looking statements regarding Coherus' current expectations about future events. Actual results may vary significantly, and we undertake no duty to update or revise any forward-looking statements. Please see the press release that we issued today and our annual report on Form 10-K for more information on risks and uncertainties.

    在開始之前,我想提醒各位,今天的電話會議包含前瞻性陳述,涉及 Coherus 對未來事件的當前預期。實際結果可能有重大差異,我們不承擔更新或修訂任何前瞻性陳述的義務。有關風險與不確定性的更多資訊,請參閱我們今天發布的新聞稿以及 Form 10-K 年度報告。

  • And now I'll turn the call over to Denny.

    現在我把電話交給 Denny。

  • Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

    Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

  • Thank you, Carrie, and thank you all for joining us today on our Q4 2025 call and our 2025 annual summary to investors. This was a year in which we completed our strategic transformation to an innovative oncology company focused on overcoming immune resistance in cancer. This transition was initiated in September of 2023 with the acquisition of Surface Oncology, a transaction through which we acquired two very promising assets, tagmokitug, a potentially best-in-class CCR8 Treg cell depleter, and casdozokitug, a first-in-class anti-IL-27 inhibitor.

    謝謝你,Carrie,也感謝各位今天參加我們 2025 年第四季電話會議,以及我們向投資人提供的 2025 年度總結。這一年,我們完成了策略性轉型,成為一家創新腫瘤公司,聚焦於克服癌症中的免疫抗性。這項轉型始於 2023 年 9 月我們收購 Surface Oncology;透過該交易,我們取得兩項極具前景的資產:tagmokitug(可能為同類最佳的 CCR8 Treg 細胞清除劑)以及 casdozokitug(同類首創的抗 IL-27 抑制劑)。

  • Over the subsequent 18-months or so, we have successfully divested our biosimilar franchise, putting $250 million in the balance sheet, reduced our $480 million secured and convertible debt by over 90% to $38.8 million, reduced our headcount and expenses, sharply refocusing the company. Building on our past successes, we enhanced our team as well as our board of directors to meet the new mission.

    在隨後約 18 個月期間,我們成功剝離生物相似藥業務,為資產負債表帶來 2.5 億美元;將 4.8 億美元的擔保及可轉換債務削減逾 90%,降至 3,880 萬美元;並縮減人力與費用,使公司重新聚焦。在過往成功的基礎上,我們也強化了團隊與董事會,以符合新的使命。

  • We also initiated an elegantly efficient clinical development program across our pipeline products in combination with LOQTORZI as well as partners products, potentially enabling the initiation of a registration trial in 2027. You will hear details of our clinical strategy and progress from Dr. Rosh Dias, our Chief Medical Officer.

    我們也啟動了一項精巧且高效率的臨床開發計畫,讓我們的管線產品可與 LOQTORZI 以及合作夥伴的產品進行聯合治療,並有望在 2027 年啟動註冊性試驗。您將從我們的首席醫療長 Rosh Dias 博士聽到臨床策略與進展的細節。

  • We also launched our first innovative oncology commercial product, LOQTORZI, in 2024, a next-gen PD-1 inhibitor as the only available and approved product for recurrent, locally advanced or metastatic Nasopharyngeal Carcinoma in the US, a $250 million addressable market. We have made very rapid progress on our transformation in the context of our products, our development strategies, and our deal-making.

    我們也在 2024 年推出首個創新腫瘤商業化產品 LOQTORZI;這是一款新一代 PD-1 抑制劑,且是在美國針對復發性、局部晚期或轉移性鼻咽癌(NPC)唯一可取得且已獲核准的產品,對應約 2.5 億美元的可服務市場。在產品、研發策略與交易推進方面,我們的轉型進展非常迅速。

  • Let me provide you with a strategic lens through which to view the company going forward. First, to our financial strategy. LOQTORZI plays a foundational role as both a revenue generator in the context of NPC and revenue multiplier in the context of combination therapy with our pipeline assets. I believe Coherus is unique as a clinical stage small biotech company because we have a commercial asset with growing sales in a rare disease space with no FDA-approved competing products on the horizon, outstanding six-year survival data, and we are positioned at the top of the NCCN guidelines for recurrent metastatic NPC.

    接下來我將提供一個策略視角,協助各位理解公司未來的發展。首先談財務策略。LOQTORZI 扮演基礎性角色:一方面在 NPC 領域創造營收,另一方面在與我們管線資產進行聯合治療時成為營收倍增器。我認為 Coherus 在臨床階段的小型生技公司中相當獨特,因為我們擁有一項商業化資產:在罕見疾病領域銷售持續成長、短期內沒有 FDA 核准的競品在望、具備優異的六年存活數據,且在復發/轉移性 NPC 的 NCCN 指南中位居首選位置。

  • This gives us confidence in LOQTORZI's continued growth. As you will hear from my colleagues, LOQTORZI more than doubled its sales in 2025 over 2024. We view LOQTORZI as reliable, growing, non-dilutive revenue source and financing vehicle to support operations while we advance the promising pipeline, increasing in value along the way. That's its fundamental role.

    這讓我們對 LOQTORZI 的持續成長充滿信心。如同您稍後將從我的同事們聽到的,LOQTORZI 在 2025 年的銷售額相較 2024 年成長逾一倍。我們將 LOQTORZI 視為可靠、成長中、非稀釋性的營收來源與融資工具,用以支持營運,同時推進具前景的研發管線,並在過程中提升價值。這就是它的根本角色。

  • Our expected trajectory achieves peak market share sometime in 2028, corresponding to $175 million in annualized revenues or about 70% market share of the $250 million market total. You will hear more about that from Sameer Goregaoker, our Chief Commercial Officer, in just a moment. Let me make some key observations for you.

    我們預期的成長軌跡是在 2028 年左右達到市場占有率高峰,對應年化營收 1.75 億美元,或約占 2.5 億美元總市場的 70% 市占率。稍後我們的首席商務長 Sameer Goregaoker 將進一步說明。我想提出幾點關鍵觀察。

  • First, while $175 million a year revenue may appear modest, it's very important to us as it's more than sufficient to fund our core burn and overall headcount, not including development costs or other extraneous items like stock option expense. Secondly, along the way, once we achieve about $15 million or $16 million a quarter in sales, the commercial effort will have paid for itself and start contributing to covering the company's overall SG&A. We believe this will happen sometime in 2026.

    第一,雖然每年 1.75 億美元的營收看起來可能不算龐大,但對我們非常重要,因為這已足以支應我們的核心現金消耗與整體人力規模(不含研發成本或其他非核心項目,例如員工認股權費用)。第二,在達成每季約 1,500 萬至 1,600 萬美元銷售額後,商業化投入將可回本,並開始為公司整體的銷售、一般及行政費用(SG&A)分攤做出貢獻。我們相信這將在 2026 年某個時間點發生。

  • Lastly, once we achieve approximately $30 million to $35 million per quarter, our core burn, which does not include clinical trial expense, which are somewhat elastic and discretionary, will be paid for by such revenues. We believe this will happen sometime in 2027. We recently raised about $50 million, which included support for the commercial effort, so we can get to that $175 million run rate faster. Also, we deemed it strategically prudent to further invest in the tagmokitug clinical program as the Treg field is increasingly competitive with some expected data readouts by other parties this year.

    最後,當我們每季達到約 3,000 萬至 3,500 萬美元時,我們的核心現金消耗(不包含臨床試驗費用;臨床費用具有一定彈性且可酌情調整)將可由這些營收支應。我們相信這將在 2027 年某個時間點發生。我們近期募得約 5,000 萬美元,其中包含對商業化推進的支持,讓我們能更快達到 1.75 億美元的營收運行率。此外,鑑於 Treg 領域競爭日益激烈,且今年其他公司預期將有數據讀出,我們認為在策略上進一步投資 tagmokitug 的臨床計畫是審慎之舉。

  • Given the recent raise in our financial plans, we believe we are certainly sufficiently funded through key to day layouts in '26 and on into 2027. My Chief Financial Officer, Bryan McMichael, will provide more color in just a moment. Let me turn to our product strategy. In addition to LOQTORZI, we have two well-positioned product candidates, both showing promising early clinical results.

    基於近期募資以及我們的財務規劃,我們相信公司資金足以支應至 2026 年的關鍵里程碑,並延續到 2027 年。我們的首席財務長 Bryan McMichael 稍後將提供更多說明。接著談產品策略。除了 LOQTORZI 之外,我們還有兩項定位良好的產品候選藥物,且皆展現出令人鼓舞的早期臨床結果。

  • Their differentiated key attributes provide risk diversification for investors. On the one hand, we see tagmokitug as potentially a best-in-class in a competitive space with broad clinical therapeutic utility and very promising biology. In a moment, Dr. Lavallee will provide you some additional scientific insights on its mechanism of action and combination therapy considerations.

    它們差異化的關鍵特性,為投資人提供風險分散。一方面,我們認為 tagmokitug 在競爭激烈的領域中可能成為同類最佳,具備廣泛的臨床治療應用潛力與非常有前景的生物學基礎。稍後 Lavallee 博士將就其作用機制與聯合治療考量提供更多科學洞見。

  • The breadth of potential utility mandates broader early-stage clinical investigation, we have several trials underway. We intend to exploit this potential broad utility by not just pursuing proprietary combinations, but also by joining with partners. Our objective to be the Treg depleter of choice across cancer treatments and modality.

    其潛在應用範圍之廣,要求我們在早期階段進行更廣泛的臨床探索;目前我們已有多項試驗正在進行。我們計畫透過不僅推進自有的聯合療法,也與合作夥伴攜手,來發揮這項廣泛應用的潛力。我們的目標是成為跨癌症治療與不同治療模式的首選 Treg 清除劑。

  • We also believe that casdozokitug is the first and only in class and with impressive translational data sharply focused on various tissue cancers such as liver and lung. Consistent with that data, casdozokitug demonstrated highly durable complete response rates in first-line hepatocellular carcinoma. Follow-on trial is underway. Dr. Dias will describe this to you subsequently.

    我們也相信 casdozokitug 為同類首創且目前唯一的藥物,並具備令人印象深刻的轉譯研究數據,聚焦於肝臟、肺部等多種實體腫瘤。與該等數據一致,casdozokitug 在一線肝細胞癌中展現高度持久的完全緩解率。後續試驗正在進行中。Dias 博士稍後將進一步說明。

  • Lastly, let me talk about the deals. Coherus has a strong track record of creating value for investors with strategic transactions, including acquisitions, divestitures, and product partnerships. We believe that this demonstrated competency is the key to unlocking latent value, opening up new markets, and creating synergies therapeutically and globally.

    最後,我想談談交易。Coherus 在透過策略性交易(包括收購、剝離與產品合作夥伴關係)為投資人創造價值方面,擁有強勁的實績。我們相信,這項已被證明的能力是釋放潛在價值、開拓新市場,並在治療層面與全球層面創造協同效益的關鍵。

  • As an example, I'll point out that the J&J collaboration is important for a number of reasons. First, it stands as the first example of our objective to be the Treg depleter of choice broadly across companies and treatment modalities. More such relationships are in development. Secondly, it stands as validation of our high scientific competency and the quality of our asset.

    舉例來說,我要指出與 J&J 的合作之所以重要,原因有好幾點。首先,這是我們實現「成為跨公司與跨治療模式之首選 Treg 清除者」目標的第一個例證。更多此類合作關係正在推進中。其次,這也驗證了我們卓越的科學能力以及資產的品質。

  • And lastly, it shows that we have constructed a strategy that is both executable and potentially accretive to shareholders. As you know, we have global rights to tagmokitug and casdozokitug, and we look forward to ex US partnership opportunities as the data readouts emerge this year and next. We believe that it is reasonable to expect such partners will provide upfront payments and contribute their share to significantly offset pivotal or registration trial costs as they carry the expenses for the patients in their territories.

    最後,這顯示我們已建立一套既可執行、且有望為股東帶來增值的策略。如各位所知,我們擁有 tagmokitug 與 casdozokitug 的全球權利,並期待隨著今年與明年的數據讀出,出現美國以外(ex-US)的合作夥伴機會。我們認為,合理的預期是此類合作夥伴將提供預付款,並分擔其應負擔的部分,以在很大程度上抵銷關鍵性或註冊性試驗成本,因為他們將承擔其所屬區域內患者相關的費用。

  • This will leave us responsible for a minority share of overall costs, which we expect to be manageable. In closing, let me summarize for you. Over the last 18-months or so, we have made substantial progress on putting together a highly executable plan comprised of integrated financial, product, and transaction strategies, positioning us to provide significant investor value accretion.

    如此一來,我們僅需承擔整體成本中的少數部分,我們預期這是可控的。最後,讓我為各位做個總結。在過去約 18 個月左右,我們在建立一套高度可執行的計畫方面取得了實質進展;該計畫由整合性的財務、產品與交易策略所構成,使我們得以為投資人創造顯著的價值增厚。

  • Let me now turn the call over to Dr. Theresa Lavallee, our Chief Scientific and Development Officer, who will provide some greater insights into the use of T-regulatory cell depletion as a therapeutic approach to overcome immune resistance in cancer.

    接下來我把電話會議交給我們的首席科學與開發長 Theresa Lavallee 博士,她將就以調節性 T 細胞(T-regulatory cell)清除作為治療策略、以克服癌症免疫抗性,提供更深入的見解。

  • Theresa?

    Theresa?

  • Theresa Lavallee - Chief Development Officer

    Theresa Lavallee - Chief Development Officer

  • Thank you, Denny. Good afternoon. Today, I will focus my remarks on tagmokitug, our potent and selective cytolytic anti-CCR8 antibody, its mechanism of action, and the potential for its therapeutic use. As background, T-regulatory cells, or Tregs, are an increasingly recognized important cell type for the treatment of cancer.

    謝謝你,Denny。各位下午好。今天我將把重點放在 tagmokitug——我們具高效力且具選擇性的細胞溶解型(cytolytic)抗 CCR8 抗體——其作用機制,以及其潛在的治療用途。作為背景,調節性 T 細胞(T-regulatory cells,或 Tregs)正日益被認為是癌症治療中一種重要的細胞類型。

  • As tumors exploit Tregs to evade the immune system, this has the consequence of promoting cancer growth and metastasis. Higher levels of Tregs are associated with poor prognosis in many different tumor types, including head and neck, lung, breast, colon, prostate, stomach cancers. The other problem with Tregs is that Tregs are not only associated with poor prognosis, but also can be upregulated with anti-cancer treatments.

    由於腫瘤會利用 Tregs 來逃避免疫系統,結果會促進癌症生長與轉移。在許多不同的腫瘤類型中,較高的 Tregs 水平與較差的預後相關,包括頭頸癌、肺癌、乳癌、結腸癌、前列腺癌、胃癌。Tregs 的另一個問題是,Tregs 不僅與不良預後相關,也可能在抗癌治療下被上調。

  • The reason I highlight this is as drugs that deplete Tregs may be able to improve patient outcomes for many different anti-cancer treatments. Tagmokitug targets CCR8, which is preferentially expressed Tregs in tumors. We recently published the characterization of tagmokitug pharmacology and molecular cancer therapeutics.

    我之所以強調這點,是因為能清除 Tregs 的藥物,可能有助於改善多種不同抗癌治療的病人結局。Tagmokitug 靶向 CCR8,而 CCR8 在腫瘤中的 Tregs 上具有偏好性表達。我們近期已在《Molecular Cancer Therapeutics》發表了 tagmokitug 藥理特性之表徵研究。

  • What we have shown in the clinic with tagmokitug that treatment leads to two important changes in the tumor immune makeup. First, the selective and significant depletion of CCR8 positive Tregs in tumors. Second, a massive increase in CD8 T cells. These data show that tagmokitug both removes the suppressor cell in tumors and leads to an increase in T cells that can kill the cancer cells.

    我們在臨床上以 tagmokitug 所顯示的是,治療會導致腫瘤免疫組成出現兩項重要變化。第一,在腫瘤中選擇性且顯著地清除 CCR8 陽性的 Tregs。第二,CD8 T 細胞大幅增加。這些數據顯示,tagmokitug 既能移除腫瘤中的抑制性細胞,也能促使可殺死癌細胞的 T 細胞增加。

  • However, the CCR8 class of drugs has shown limited single agent activity, which raises the question of what do these T cells need to activate them to kill the tumor? We are investigating two different approaches for T cell activation. PD-1 antibodies are one way to activate killer T cells. Over the last decade of using these drugs, we have learned the mechanism of PD-1 inhibitors is to reinvigorate T cells that have previously tried to attack the tumor but are now exhausted.

    然而,CCR8 類藥物作為單藥的活性表現有限,這就引出一個問題:這些 T 細胞需要什麼樣的訊號才能被活化以殺死腫瘤?我們正在研究兩種不同的 T 細胞活化方式。PD-1 抗體是活化殺手 T 細胞的一種方式。在過去十年使用這些藥物的經驗中,我們了解到 PD-1 抑制劑的機制是讓先前曾嘗試攻擊腫瘤、但如今已耗竭的 T 細胞重新恢復活性。

  • We are trying to understand if the T cells observed in the tumors following tagmokitug treatment are antigen-experienced exhausted T cells or possibly naive T cells. Rosh will describe in more detail our tagmokitug clinical studies evaluating treatment with toripalimab, our PD-1 antibody. The results of our phase I study include a partial response in a fourth-line head and neck cancer patient who had progressed on prior PD-1 therapy.

    我們正試圖釐清,在 tagmokitug 治療後於腫瘤中觀察到的 T 細胞,是具抗原經驗的耗竭 T 細胞,或可能是初始(naive)T 細胞。Rosh 將更詳細說明我們的 tagmokitug 臨床研究,該研究評估與 toripalimab(我們的 PD-1 抗體)合併治療。我們第一期研究的結果包括:一位接受第四線治療的頭頸癌患者,在先前 PD-1 治療後仍進展,但在本研究中出現部分緩解。

  • Since tagmokitug added to toripalimab rescued the prior PD-1 failed response, this exciting data demonstrated that CCR8 positive Tregs were a primary mechanism of resistance. Our ongoing expansion cohort in head and neck cancer is designed to answer if CCR8 positive Tregs are a primary PD-1 resistance mechanism in this second-line patient population.

    由於在 toripalimab 中加入 tagmokitug 能挽救先前 PD-1 治療失敗的反應,這項令人振奮的數據顯示 CCR8 陽性 Tregs 是主要的抗藥機制。我們在頭頸癌的持續擴增隊列(expansion cohort)旨在回答:在此第二線治療病人族群中,CCR8 陽性 Tregs 是否為 PD-1 抗性的一項主要機制。

  • The other approach we are investigating for T cell activation following tagmokitug treatment is the direct activation of the T cell receptor complex by simulating a protein called CD3. This allows for the activation of naive T cells. Many T cell engagers or TCEs are bispecific antibodies that bind a tumor protein on one end and CD3 on T cells on the other end. TCEs lead to redirected T cell killing of the tumor and have success in hematological malignancies, but limited success so far in solid tumors.

    我們正在研究的另一種在 tagmokitug 治療後活化 T 細胞的方法,是透過模擬一種稱為 CD3 的蛋白,直接活化 T 細胞受體複合體。這使得初始(naive)T 細胞得以被活化。許多 T 細胞接合器(T cell engagers,或 TCEs)是雙特異性抗體,一端結合腫瘤蛋白,另一端結合 T 細胞上的 CD3。TCEs 可引導 T 細胞重新定向殺傷腫瘤,並已在血液惡性腫瘤中取得成功,但迄今在實體腫瘤中的成功仍有限。

  • Data support there are two main issues in solid tumors leading to modest TCE activity. A low density of T cells in the tumors for the molecule to bind both the tumor and the T cell in close proximity. And secondly, Tregs presence and also activation leading to suppressing T cell response. We are pleased to have announced the agreement with Johnson & Johnson to study the combination of tagmokitug, a Treg depleting antibody, with pasritamig, a prostate-specific TCE binding to KLK2 on prostate tumors.

    數據支持在實體腫瘤中導致 TCE 活性僅屬溫和的兩個主要問題。其一是腫瘤內 T 細胞密度偏低,使分子難以同時在近距離內結合腫瘤與 T 細胞。其二是 Tregs 的存在以及其被活化,進而抑制 T 細胞反應。我們很高興宣布與 Johnson & Johnson 達成協議,研究將 tagmokitug(Treg 清除抗體)與 pasritamig(前列腺特異性 TCE,結合前列腺腫瘤上的 KLK2)合併使用。

  • With the advancement of this combination study, tagmokitug becomes the first CCR8 antibody in prostate cancer and the first CCR8 antibody in combination with a TCE. Coherus Oncology continues to lead the science for the CCR8 class of drugs. As I indicated earlier, Tregs are known to limit cancer therapy, tagmokitug has now shown it is a targeted therapeutic approach to deplete Tregs and change the immune balance by increasing T cells in tumors.

    隨著此合併研究的推進,tagmokitug 成為首個用於前列腺癌的 CCR8 抗體,也是首個與 TCE 合併使用的 CCR8 抗體。Coherus Oncology 持續在 CCR8 類藥物的科學研究上保持領先。如我先前所述,Tregs 已知會限制癌症治療;tagmokitug 現已顯示其為一種具靶向性的治療方法,可清除 Tregs,並透過增加腫瘤中的 T 細胞來改變免疫平衡。

  • Importantly, all immune activating agents, immune checkpoint inhibitors like PD-1 inhibitors and TCEs, increase the number of Tregs in tumors, as do most anti-cancer treatments. For example, a recently published study showed that androgen receptor deprivation therapy increases Tregs in prostate cancer, and there is a number of scientific reports showing that radiation, chemotherapy, targeted therapies, angiogenesis inhibitors also increase Tregs in tumors, and this associates with worse outcomes for patients.

    重要的是,所有免疫活化藥物——包括 PD-1 抑制劑等免疫檢查點抑制劑以及 TCEs——都會增加腫瘤中的 Tregs 數量,多數抗癌治療亦然。例如,近期發表的一項研究顯示,雄激素受體剝奪治療會增加前列腺癌中的 Tregs;此外也有多篇科學報告指出,放射治療、化學治療、標靶治療、血管新生抑制劑同樣會增加腫瘤中的 Tregs,而這與病人較差的治療結果相關。

  • We believe that there is broad potential for tagmokitug to be used in combination with other therapies as a cancer treatment, and we are excited that pasritamig/tagmokitug combination is the first with a partner company. And of course, we continue to explore novel combinations with other partners.

    我們相信 tagmokitug 具有廣泛潛力,可與其他療法合併作為癌症治療;我們也很振奮 pasritamig/tagmokitug 的合併是第一個與合作夥伴公司共同推進的組合。當然,我們也將持續與其他合作夥伴探索創新的合併方案。

  • With that, I will turn it over to Dr. Dias, who will further describe the clinical development. Rosh?

    接下來我把時間交給 Dias 博士,他將進一步說明臨床開發進展。Rosh?

  • Rosh Dias - Chief Medical Officer

    Rosh Dias - Chief Medical Officer

  • Thank you, Theresa, and good afternoon, everyone. I'm pleased with the continued progress of our multi-regional clinical development program for both tagmokitug and casdozokitug. Programs for both molecules address areas of clear unmet medical need in very intentionally designed clinical studies, which are supported by strong scientific and clinical rationale.

    謝謝你,Theresa,也向各位致意下午好。我很高興看到我們針對 tagmokitug 與 casdozokitug 的多區域臨床開發計畫持續取得進展。這兩個分子的計畫皆透過經過深思熟慮設計的臨床研究,聚焦於明確的未被滿足醫療需求領域,並有強而有力的科學與臨床理據支持。

  • We remain on track for initial data readouts from mid-'26 onwards, as we've previously communicated. Let me now take a few minutes to highlight each program individually. Firstly, tagmokitug, our highly selective CCR8 cytolytic antibody, for which we're currently running two protocols in what we've named our TregCheck program.

    如同我們先前所溝通的,我們仍按計畫自 2026 年年中起陸續取得初步數據讀出。接下來我將用幾分鐘分別重點說明各項計畫。首先是 tagmokitug,我們高度選擇性的 CCR8 細胞溶解型抗體;目前我們在名為 TregCheck 的計畫中,正執行兩項試驗方案(protocol)。

  • The first protocol, in a second-line head and neck squamous cell population, builds upon the exciting data we presented at AACR 2025, where we showed data demonstrating clear tumor remodeling with Tagmo monotherapy, with depletion of CCR8-positive Tregs, accompanied by a profound increase in the CD8 positive T-cells, consistent with a much more cytotoxic tumor microenvironment.

    第一項試驗方案在二線頭頸部鱗狀細胞癌族群中進行,建立在我們於 AACR 2025 發表的令人振奮數據之上;當時我們展示了 Tagmo 單藥治療可帶來明確的腫瘤重塑,伴隨 CCR8 陽性 Treg 的耗竭,並且 CD8 陽性 T 細胞顯著增加,與更具細胞毒性的腫瘤微環境一致。

  • As you've just heard, combinations facilitate activation of these ingressed T-cells. In the same study, when Toripalimab was added, we showed a partial response in a fourth-line head and neck squamous cell patient refractory to prior PD-1 therapy. Our current head and neck squamous cell approach looks at 40 patients in 2 doses of Tagmo in combination with Tori and asks the question as to whether Tagmo is able to reverse PD-L1 resistance in the second-line population. We continue to anticipate initial data mid-year '26.

    如同你剛才聽到的,聯合治療有助於活化這些浸潤進入的 T 細胞。在同一項研究中,當加入 Toripalimab 時,我們在一位對既往 PD-1 治療無反應的第四線頭頸部鱗狀細胞癌患者中觀察到部分緩解。我們目前的頭頸部鱗狀細胞癌策略是在 40 位患者中,以兩個 Tagmo 劑量與 Tori 聯合,探討 Tagmo 是否能在二線族群中逆轉 PD-L1 抗藥性。我們仍預期於 2026 年年中取得初步數據。

  • Our second protocol is an umbrella protocol with four targeted tumor types in cohorts A to D, including second-line upper GI adenocarcinoma, second-line ESCC, first-line ESCC, and fourth-line plus colorectal carcinoma, respectively. The upper GI adeno cohort is a second-line cohort, including gastric adeno, GEJ, and esophageal adenocarcinoma, also broadly asking the question of whether Tagmo is able to reverse PD-L1 resistance.

    第二項試驗方案為一項傘式試驗,針對 A 至 D 四個隊列的四種目標腫瘤類型,分別為二線上消化道腺癌、二線食道鱗狀細胞癌(ESCC)、一線 ESCC,以及第四線以上結直腸癌。上消化道腺癌隊列為二線隊列,包含胃腺癌、胃食道交界(GEJ)與食道腺癌,同樣廣泛地探討 Tagmo 是否能逆轉 PD-L1 抗藥性。

  • As a reminder, this is a tumor type that has shown proof of principle of the class, with Lenova Medicine showing data for their CCR8 in combination with our PD-1 inhibitor, Tori, at ASCO 2024, with an encouraging overall response rate in a second-line plus gastric population. Our upper GI adeno cohort looks at two doses of Tagmo in combination with Tori in 40 subjects.

    提醒一下,這是一種已展現該類別「概念驗證」的腫瘤類型;Lenova Medicine 在 ASCO 2024 發表其 CCR8 與我們的 PD-1 抑制劑 Tori 聯合的數據,在二線以上胃癌族群中呈現令人鼓舞的整體反應率。我們的上消化道腺癌隊列在 40 名受試者中評估兩個 Tagmo 劑量與 Tori 的聯合治療。

  • Again, we continue to anticipate early data around the middle of this year. Our esophageal squamous cell cohorts take advantage of the activity of Tori irrespective of PD-L1 levels, which is perhaps most marked in this tumor type and which forms the basis of Tori's approval as the only EU-approved PD-1 for esophageal squamous cell irrespective of PD-L1 status.

    同樣地,我們仍預期在今年年中左右取得早期數據。我們的食道鱗狀細胞癌隊列利用了 Tori 不受 PD-L1 表現量影響的活性;這一點在此腫瘤類型中可能最為明顯,也構成 Tori 獲批成為歐盟唯一一款不論 PD-L1 狀態皆可用於食道鱗狀細胞癌之 PD-1 的基礎。

  • Cohort B is a second-line esophageal cohort with two doses of Tagmo in combination with Tori. Cohort C looks at first-line esophageal population with Tagmo in combination with both Tori and chemo, with the explicit intention of developing safety data in combination with chemo, which could allow us to explore earlier treatment paradigms.

    B 隊列為二線食道隊列,採用兩個 Tagmo 劑量與 Tori 聯合。C 隊列評估一線食道族群,使用 Tagmo 與 Tori 及化療三方聯合,明確目的在於建立與化療聯用的安全性數據,從而使我們能探索更早期的治療模式。

  • We anticipate data in the second half of this year for these two cohorts. Cohort D looks at Tagmo in combination with Tori in the fourth-line plus colorectal carcinoma population, an area which constitutes an increasing public health issue, particularly in younger age groups. As a reminder, the CCR8 field has shown some responses in CRC, our approach looks at 20 patients with an initial focus on the non-liver-met population before moving on to advance into the liver-met population.

    我們預期這兩個隊列將在今年下半年取得數據。D 隊列評估 Tagmo 與 Tori 聯合用於第四線以上結直腸癌族群;此領域正構成日益嚴重的公共衛生議題,尤其在較年輕族群中。提醒一下,CCR8 領域在結直腸癌(CRC)中已顯示出一些反應;我們的策略先以 20 位患者為起點,初期聚焦於非肝轉移族群,之後再推進至肝轉移族群。

  • We started the CRC cohort in the second half of last year, we anticipate early data late this year or perhaps even early '27. We're very excited to start the tagmokitug pasritamig combination cohort, which, as you heard from Theresa, represents both the first TCE CCR8 combination study as well as the first in CRPC and is a very rational combination based on the mechanism of action of both agents.

    我們在去年下半年啟動 CRC 隊列,預期在今年年底或甚至 2027 年初取得早期數據。我們也非常期待啟動 tagmokitug 與 pasritamig 的聯合隊列;如同你從 Theresa 那裡聽到的,這不僅是首個 TCE 與 CCR8 的聯合研究,也是首個在 CRPC 中進行的研究,且基於兩種藥物的作用機制,這是一個非常合理的組合。

  • This combination aims to build upon the pasritamig data shown at ASCO 2025, demonstrating an encouraging PSA50 in a late-line metastatic castration-resistant prostate cancer population, supporting advancement into pivotal studies. Metastatic CRPC is considered an immunologically cold tumor and has limited treatment options once patients get to later lines of therapy.

    此聯合治療旨在延續 ASCO 2025 所展示的 pasritamig 數據:在晚期線別的轉移性去勢抗性前列腺癌族群中,呈現令人鼓舞的 PSA50,支持推進至關鍵性試驗。轉移性 CRPC 被視為免疫學上的「冷」腫瘤,當患者進入較後線治療後,可用的治療選項有限。

  • Our initial approach will be in a third-line plus population, looking at a safety cohort and additional PSA50 endpoints, which we anticipate starting in the second half of this year. Moving on now to Casdozokitug, our first-in-class antibody targeting IL-27, a context-dependent immunosuppressive cytokine, particularly relevant in tumors such as Hepatocellular Carcinoma and non-small cell lung cancer.

    我們的初步策略將在第三線以上族群中進行,評估一個安全性隊列並觀察額外的 PSA50 終點;我們預期在今年下半年啟動。接著談 Casdozokitug:這是我們同類首創、靶向 IL-27 的抗體;IL-27 是一種具情境依賴性的免疫抑制性細胞激素,特別與肝細胞癌及非小細胞肺癌等腫瘤相關。

  • Our recently named Catalyze program focuses initially in first-line HCC and builds upon the very encouraging data presented at ASCO GI 2025, where we demonstrated that the addition of Casdozo to the current standard of care, Atezo and Bev, provided a 38% overall response rate and, perhaps more importantly, a complete response rate of 17%, both of which compare very favorably to historical benchmarks with activity irrespective of etiology and a strong durability of response with a favorable safety profile.

    我們近期命名的 Catalyze 計畫首先聚焦於一線肝細胞癌(HCC),並建立在 ASCO GI 2025 發表的非常令人鼓舞的數據之上;我們證明在現行標準治療 Atezo 與 Bev 的基礎上加入 Casdozo,可帶來 38% 的整體反應率,更重要的是 17% 的完全緩解率;兩者相較歷史基準皆非常有利,且不受病因影響皆具活性,反應持久性強並具良好安全性概況。

  • Our current ongoing study swaps out Atezo for our PD-1 Tori and includes 72 patients in 3 arms. That is 2 dose levels of Casdozo in combination with Tori Bev versus Tori Bev alone and is designed with three aims. Firstly, to further characterize efficacy and safety, as well as address FDA's Project Optimus and address contribution of components as we move through the development pathway.

    我們目前進行中的研究以我們的 PD-1 藥物 Tori 取代 Atezo,並在 3 個治療組別中納入 72 位患者。也就是:兩個 Casdozo 劑量水平與 Tori+Bev 聯合,對比 Tori+Bev 單獨治療,並以三個目標進行設計。第一,進一步刻畫療效與安全性;同時回應 FDA 的 Project Optimus,並在開發路徑推進過程中釐清各組成要素的貢獻。

  • This trial continues to accrue well globally, and we remain on track for initial data around mid-year '26. As a reminder, the previous study demonstrated an increase in response rate and a deepening of response with time, and so we do anticipate the same with the ongoing program. In summary, our TregCheck program with Tagmo in several targeted cohorts is intended to inform us in which of these specific tumor types we may see a signal to take forward into broader programs.

    此試驗在全球持續順利收案,我們仍按計畫於 2026 年年中左右取得初步數據。提醒一下,先前研究顯示反應率提升且反應隨時間加深,因此我們也預期在目前進行中的計畫中看到相同趨勢。總結而言,我們以 Tagmo 進行的 TregCheck 計畫涵蓋多個目標隊列,旨在協助我們判斷在這些特定腫瘤類型中,哪些可能出現可推進至更廣泛計畫的訊號。

  • Our Catalyze program with Casdozokitug is asking the question of whether we can improve on the current standard of care with the addition of Casdozokitug. The two key determinants of exact timing of data availability are firstly, the numbers of patients accrued to study, and secondly, the numbers of scans that may be required to show activity, which will differ by program. We remain on track to show initial data mid-year '26 and beyond, we'll continue to provide updates on progress.

    我們以 Casdozokitug 進行的 Catalyze 計畫,所要回答的問題是:加入 Casdozokitug 是否能優於現行標準治療。數據可取得的確切時間主要取決於兩個關鍵因素:第一,試驗收案人數;第二,為顯示活性可能需要的影像掃描次數,而這將因計畫而異。我們仍按計畫於 2026 年年中及之後展示初步數據,並將持續提供進度更新。

  • With that, I'll hand it over to Sameer. Sameer?

    接下來,我把時間交給 Sameer。Sameer?

  • Sameer Goregaoker - Chief Commercial Officer

    Sameer Goregaoker - Chief Commercial Officer

  • Thank you, Rosh. We're happy to report that LOQTORZI net revenue grew to $40.8 million for full year 2025, versus $19.1 million in 2024, representing 113% growth year-over-year. As we have stated previously, going forward, we expect average quarter-over-quarter demand growth of 10% to 15%. Similar to 2025, we will see some variability in individual quarters due to patient flow and other factors.

    謝謝你,Rosh。我們很高興報告,LOQTORZI 於 2025 全年淨營收成長至 4,080 萬美元,相較 2024 年的 1,910 萬美元,年增 113%。如同我們先前所述,展望未來,我們預期平均每季相較前一季的需求成長為 10% 至 15%。與 2025 年類似,由於病患流量及其他因素,各季度之間仍會出現一定波動。

  • For Q4, net revenue was $12.4 million and 11% growth over Q3. We saw strong quarter-over-quarter demand growth of 15.5% in Q4. The delta between net revenue and demand growth was driven by wholesaler inventory declines in Q4 versus Q3. Demand growth was driven by new patient starts in both new and existing accounts, and we saw an 11% increase in purchasing accounts, indicating continued increase in breadth of use.

    第四季淨營收為 1,240 萬美元,較第三季成長 11%。我們在第四季看到強勁的季對季需求成長 15.5%。淨營收與需求成長之間的差異,主要由第四季相較第三季批發商庫存下降所致。需求成長來自新舊客戶中的新病患啟動治療;我們也看到採購帳戶數增加 11%,顯示使用廣度持續擴大。

  • While we're happy with that 2025 growth, there remains significant opportunity, especially in the community segment, where use of chemo only and off-label IO persists. As you'll recall, the NCCN guidelines for NPC were updated late in 2024, placing LOQTORZI as the only preferred treatment for recurrent and metastatic NPC.

    雖然我們對 2025 年的成長感到滿意,但仍存在顯著機會,尤其是在社區醫療端,僅使用化療以及超適應症使用免疫腫瘤(IO)治療的情況仍然存在。如你所記得,NPC 的 NCCN 指引於 2024 年底更新,將 LOQTORZI 列為復發與轉移性 NPC 的唯一「優先推薦」治療。

  • These guidelines served as a stimulus for LOQTORZI growth in 2025, and we remain focused on driving education on the guidelines and our superior overall survival versus chemotherapy alone. That brings me to the exciting and game-changing six-year long-term overall survival data that was presented at ESMO Asia in December.

    這些指引在 2025 年成為推動 LOQTORZI 成長的催化劑,而我們仍專注於推動對該指引的教育,以及相較於單純化療,我們在整體存活期(OS)上的優勢。接下來我想談談令人振奮、具顛覆性的六年長期整體存活期數據,該數據已於 12 月在 ESMO Asia 發表。

  • This new data shows that patients on LOQTORZI plus chemo live for almost 65-months or over five-years. In contrast, chemo-only patients live for less than three-years. That is a 2.5-years of additional survival benefit for LOQTORZI patients. With this data, we believe that no patient should be receiving chemo alone for NPC, a belief that is shared by a vast majority of KOLs.

    這項新數據顯示,接受 LOQTORZI 合併化療的患者可存活將近 65 個月,亦即超過五年。相較之下,僅接受化療的患者存活不到三年。這代表 LOQTORZI 患者額外增加 2.5 年的存活獲益。基於這些數據,我們相信在 NPC 治療上不應再有患者只接受化療;而這項看法也獲得絕大多數關鍵意見領袖(KOL)的認同。

  • Our primary focus is thus on educating all target oncologists on this new survival data. We're pulling all stops to get this game-changing data in front of physicians. Our sales team has been fully trained and is focused on educating physicians as we speak. On the multi-channel side, we're taking a multi-pronged approach with several tactics, including KOL educational videos, short messages, and emails that are being delivered to target physicians.

    因此,我們的首要重點是教育所有目標腫瘤科醫師了解這項新的存活數據。我們正全力以赴,讓這項具顛覆性的數據呈現在醫師面前。我們的業務團隊已完成全面訓練,並正專注於向醫師進行教育。在多通路方面,我們採取多管齊下的策略,運用多項戰術,包括 KOL 教育影片、簡訊與電子郵件,投遞給目標醫師。

  • We're also making significant investments into CRM technology platforms and data enhancements to raise our rare disease execution using advanced analytics. We have doubled our investment to purchase additional claims data and patient alerts data. This provides us visibility into almost 70% of all US claims, which are then used to alert our sales team on real-time patient opportunities.

    我們也正大幅投資 CRM 科技平台與資料強化,運用進階分析提升我們在罕見疾病上的執行力。我們已將投資加倍,用於購買更多理賠(claims)資料與患者警示(patient alerts)資料。這讓我們能掌握接近 70% 的全美理賠資料,並用以即時提醒業務團隊把握患者機會。

  • We have expanded our field footprint to reach more physicians. While our field team focuses on tier one or high-value targets, NPC being a rare disease, patients can present at any oncology office across the country. We are thus expanding our reach by activating a remote sales team that will reach tier two physicians while the field team focuses on tier one targets.

    我們已擴大外勤覆蓋範圍,以觸及更多醫師。雖然我們的外勤團隊聚焦於第一層級或高價值目標,但由於 NPC 屬罕見疾病,患者可能在全國任何一家腫瘤科診所就診。因此,我們將透過啟動遠端業務團隊來擴大觸及,讓其接觸第二層級醫師,同時外勤團隊專注於第一層級目標。

  • There's also a sizable NPC opportunity in the Veterans Affairs hospitals. The VA hospitals are typically hard to access. We've engaged a specialized team of contract representatives, all of whom have extensive experience selling in the VA. In summary, we remain confident in meeting our goal of achieving a dominant share in the NPC market with peak share expected in 2028.

    在退伍軍人事務部(VA)醫院體系中也存在相當可觀的 NPC 機會。VA 醫院通常較難進入。我們已聘用一支專業的合約代表團隊,他們皆具備在 VA 體系銷售的豐富經驗。總結而言,我們仍有信心達成在 NPC 市場取得主導市占的目標,並預期於 2028 年達到峰值市占。

  • With the profound survival advantage that we see in the six-year long-term data, our entire commercial organization remains committed to ensuring that no patient misses the opportunity to live longer with LOQTORZI.

    鑑於我們在六年長期數據中看到的顯著存活優勢,我們整個商業組織仍致力於確保沒有任何患者錯失透過 LOQTORZI 延長存活的機會。

  • With that, I'll now pass the call to Bryan McMichael, our Chief Financial Officer.

    接下來,我將把電話會議交給我們的財務長 Bryan McMichael。

  • Bryan Mcmichael - Interim Chief Financial Officer

    Bryan Mcmichael - Interim Chief Financial Officer

  • Thank you, Sameer, good afternoon, everyone. I'll start with a review of the company's financial position at the end of the year and results for Q4. I will provide additional insights into how our balance sheet has evolved and some forward-looking color. As mentioned by Denny, over 2024 and 2025, we decreased the principal balance of our term and convertible debt by over 90% from a high of $480 million to $38.8 million at year-end 2025.

    謝謝你,Sameer,各位下午好。我將先回顧公司在年末的財務狀況以及第四季(Q4)的業績。我也會補充說明資產負債表如何演變,並提供一些前瞻性的觀點。如 Denny 所提,於 2024 與 2025 年期間,我們將定期貸款與可轉換債務的本金餘額自最高 4.8 億美元大幅降低逾 90%,至 2025 年底的 3,880 萬美元。

  • This resulted in a significant reduction of interest costs, which I will cover later. This also extended our earliest debt maturity to May 2029. Headcount decreased from about 228 at the end of 2024 to about 147 at the end of 2025, an approximate 35% reduction. Some of the most significant changes for Q4 include the reduction of legacy liabilities associated with the divested businesses.

    這使利息成本顯著下降,我稍後會再說明。同時也將我們最早的債務到期日延後至 2029 年 5 月。員工人數由 2024 年底約 228 人降至 2025 年底約 147 人,約減少 35%。第四季最顯著的變化之一,是與已剝離業務相關的既有負債(legacy liabilities)下降。

  • Specifically, accrued rebates, fees, and reserves, which comprise mostly legacy product liabilities, total $30 million at December 31. This is less than half of the $67 million balance one quarter earlier. The transition of commercial contracts to a court was mostly complete at the beginning of Q4. This initiated the wind down of TSA assets and liabilities.

    具體而言,應計回扣、費用與準備金(主要由既有產品負債構成)於 12 月 31 日合計為 3,000 萬美元。這不到前一季 6,700 萬美元餘額的一半。商業合約移轉至法院的作業在第四季初大致完成。這啟動了 TSA 資產與負債的收尾(wind down)。

  • Substantially all of the TSA receivables were collected in Q4, bringing the balance from $241 million at the start of the quarter to less than $1 million at year-end. The cash collected has been used to reduce TSA liabilities from $254 million at the start of Q4 to $65 million at year-end. We expect the remainder of the, these legacy business liabilities to be paid down in the coming quarters in a front-weighted fashion.

    第四季已收回幾乎所有 TSA 應收款,使其餘額由季初的 2.41 億美元降至年末不到 100 萬美元。所收回的現金已用於將 TSA 負債由第四季初的 2.54 億美元降至年末的 6,500 萬美元。我們預期其餘這些既有業務負債將在未來幾季以較前期集中的方式(front-weighted)償付。

  • In addition, let me remind you that we are eligible to receive two earn-out sales milestones of $37.5 million each. The criteria to earn these milestones is based on four consecutive quarters of UDENYCA sales starting in Q3 2025. $300 million within five-quarters or through Q3 2026 for the first $37.5 million milestone, and $350 million within seven-quarters or through Q1 2027 for the second milestone.

    此外,提醒各位,我們有資格獲得兩筆銷售里程碑的或有對價(earn-out),每筆為 3,750 萬美元。達成這些里程碑的條件,是以自 2025 年第三季(Q3 2025)起連續四個季度的 UDENYCA 銷售為基礎:第一筆 3,750 萬美元里程碑為在五個季度內(或至 2026 年第三季 Q3 2026)達到 3 億美元;第二筆里程碑為在七個季度內(或至 2027 年第一季 Q1 2027)達到 3.5 億美元。

  • With two-quarters of sales relative to the earn-out term behind us, we believe we are favorably positioned to earn these payments and will re-keep you updated. Sameer covered in detail LOQTORZI net revenues year-over-year growth and the additional investments in commercial infrastructure to expand sales that we are making. We expect to provide full year 2026 revenue guidance on our earnings call in August.

    在 earn-out 期間的銷售中,我們已走過兩個季度;我們認為目前處於有利位置以取得這些款項,並將持續向各位更新。Sameer 已詳細說明 LOQTORZI 淨營收的年對年成長,以及我們為擴大銷售而追加的商業基礎建設投資。我們預期將在 8 月的法說會中提供 2026 全年營收指引。

  • Let me now turn to OpEx. With Q4 falling largely in line with the trends we saw throughout 2025. Specifically, SG&A expenses from continuing operations decreased to $23.6 million, down from $29.6 million in Q4 last year. It's important to note that this represents the fourth consecutive quarter that these expenses were flat or down as we completed the transformation of the business.

    接下來談營業費用(OpEx)。第四季大致符合我們在 2025 年全年的趨勢。具體而言,持續營運的銷售、一般及行政(SG&A)費用降至 2,360 萬美元,低於去年第四季的 2,960 萬美元。值得注意的是,隨著我們完成業務轉型,這已是連續第四個季度該費用持平或下降。

  • The decreases are primarily due to reduced head count, exiting biosimilars, and spending discipline. R&D expenses from continuing operations in Q4 were $31 million as compared to $20.8 million in Q4 2024. In contrast to SG&A, R&D expenses slightly increased every quarter in 2025 as we invested in Coherus's promising pipeline.

    下降主要來自人力縮減、退出生物相似藥業務,以及支出紀律。持續營運的研發(R&D)費用在第四季為 3,100 萬美元,相較 2024 年第四季的 2,080 萬美元。與 SG&A 不同,研發費用在 2025 年每一季皆略有增加,因為我們投資於 Coherus 具前景的產品線(pipeline)。

  • Of course, reduction of debt has resulted in significant reduction in cash paid for interest. This relates to borrowings reflected in both continuing and discontinued operations, and was $9.9 million in 2025. This reflects a savings of greater than $15 million over the $25.4 million paid in 2024 and underscores the benefit from the paydowns of debt in 2024 and 2025.

    當然,債務降低也使支付利息的現金大幅減少。這與列示於持續與終止營運中的借款相關,2025 年為 990 萬美元。相較於 2024 年支付的 2,540 萬美元,節省超過 1,500 萬美元,凸顯我們在 2024 與 2025 年償還債務所帶來的效益。

  • We had cash equivalents, and investments of $172.1 million at year-end. As you know, we recently raised capital, including a $50 million follow-on offering last month. Use of these funds include, first, investments to support the significant upside potential of the pipeline. This includes additional indications of tagmokitug as Treg depletion has emerged as a very important MOA in cancer therapy.

    年末我們持有現金、約當現金與投資合計 1.721 億美元。如各位所知,我們近期完成募資,包括上個月 5,000 萬美元的後續發行(follow-on offering)。這些資金的用途包括:第一,用於支持產品線顯著上行潛力的投資。其中包含 tagmokitug 的額外適應症,因為 Treg 耗竭已成為癌症治療中非常重要的作用機轉(MOA)。

  • Recent examples include our phase IIa CRC study, as well as the anticipated start of the combination study with J&J in metastatic prostate cancer. We are making additional investments in our commercial footprint and capabilities to pursue the $250 million commercial opportunity presented in LOQTORZI and NPC, as covered by Sameer.

    近期例子包括我們的第二期 a(Phase IIa)CRC 研究,以及預期將啟動與 J&J 在轉移性前列腺癌的合併研究。我們也正額外投資於商業覆蓋與能力,以把握 Sameer 所提 LOQTORZI 與 NPC 所帶來的 2.5 億美元商業機會。

  • He discussed how our growing LOQTORZI sales will cover more and more costs in the coming years. To add some color, at the point that our commercial effort is paying for itself, we mean that LOQTORZI sales will cover costs, royalties, and cash costs of the sales force. When revenues cover c-core burn, we're referring to the commercial, these commercial efforts plus other cash costs other than those directly related to clinical trials.

    他討論了我們不斷成長的 LOQTORZI 銷售額將在未來幾年涵蓋越來越多成本。補充說明一下,當我們說商業化投入能夠自給自足時,我們的意思是 LOQTORZI 的銷售額將能夠覆蓋成本、權利金,以及銷售團隊的現金成本。當我們說營收能覆蓋 c-core burn(核心現金消耗)時,我們指的是商業端:這些商業化努力加上其他現金成本(不包含與臨床試驗直接相關的成本)。

  • With that, I will hand the call back over to Denny.

    接下來,我把電話交回給 Denny。

  • Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

    Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

  • Thank you, Brian. We're pleased with our progress in 2025, having doubled LOQTORZI sales while completing the transformation from biosimilar company to an innovative oncology company focused on overcoming immune resistance in cancer. We are particularly pleased that at the same time, we're able to reduce overall debt by over 90% since its peak in 2024 to just $38.8 million at the end of 2025.

    謝謝你,Brian。我們對 2025 年的進展感到滿意:在 LOQTORZI 銷售額翻倍的同時,也完成了從生物相似藥公司轉型為創新腫瘤公司,聚焦於克服癌症中的免疫抗性。我們也特別高興的是,同期我們能將整體負債自 2024 年高峰以來降低超過 90%,到 2025 年底僅剩 3,880 萬美元。

  • We are now strategically well-positioned with growing revenues from our foundational PD-1 inhibitor, deal opportunities across the portfolio and geographies, and two promising pipeline candidates with multiple 2026 clinical readouts.

    目前我們在策略上已處於有利位置:以我們的基礎 PD-1 抑制劑帶來的營收持續成長,投資組合與各地區皆有合作交易機會,並且有兩個具前景的管線候選藥物,將在 2026 年有多項臨床讀出。

  • Operator, we're ready to take the questions.

    主持人,我們準備好開始回答問題。

  • Operator

    Operator

  • (Operator Instructions) Jay Olson, Oppenheimer.

    (主持人指示)Jay Olson,Oppenheimer。

  • Jay Olson - Analyst

    Jay Olson - Analyst

  • Congrats on the progress. We had a couple of questions on LOQTORZI. Can you please provide some more color on the dynamic between new patient starts and repeat patients in 2025, then how you anticipate that balance to shift throughout the course of 2026? And also, if you could talk about the promotional sensitivity of LOQTORZI and any details in the sort of commercial infrastructure investments that you're planning to make this year, such as increased field force. Then I had a follow-up on tagmo, if I could.

    恭喜你們的進展。我們有幾個關於 LOQTORZI 的問題。能否請你們更具體說明 2025 年新啟用病患與回診(續用)病患之間的動態,並談談你們預期這個平衡在 2026 年全年將如何變化?另外,也請談談 LOQTORZI 對推廣活動的敏感度,以及你們今年計畫進行的商業基礎建設投資細節,例如是否會增加外勤銷售人力。然後如果可以的話,我還有一個關於 Tagmo 的追問。

  • Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

    Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

  • Thank you for your question, Jay. I'll let Sameer address the issue on the new versus repeat patients and then move on. Go ahead, Sameer.

    謝謝你的提問,Jay。我先請 Sameer 回答新病患與續用病患的議題,然後再往下。Sameer,請。

  • Sameer Goregaoker - Chief Commercial Officer

    Sameer Goregaoker - Chief Commercial Officer

  • Yes. Thank you for the question, Jay. Regarding new versus existing patients, in 2025, approximately 25% of our business came from new patients, and the rest came from continuing patients. As you mentioned, what does that look like in the future? I think that mix will shift slightly more towards new patients because we have a lot of opportunity to grow in the new patients. The existing patients will always remain a strong base of our business because over time, we expect the duration of therapy to keep increasing as well.

    好的。謝謝你的問題,Jay。關於新病患與既有病患,2025 年我們約 25% 的業務來自新病患,其餘則來自持續治療的病患。如你所問,未來會如何?我認為這個組合會稍微往新病患傾斜,因為我們在新病患端有很大的成長機會。既有病患也會一直是我們業務的強勁基礎,因為隨著時間推移,我們也預期治療持續時間會持續增加。

  • Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

    Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

  • Sameer, can you address Jay's question regarding the promotional sensitivity of the product?

    Sameer,你能回答 Jay 關於產品推廣敏感度的問題嗎?

  • Sameer Goregaoker - Chief Commercial Officer

    Sameer Goregaoker - Chief Commercial Officer

  • Sure. Regarding promotional sensitivity, LOQTORZI is extremely promotion sensitive, because our challenge is that physicians in the community, they usually see 10-15 different cancer types, and they don't see LOQTORZI, they see maybe one or two NPC patients in a given year. They have to be continuously reminded about LOQTORZI and the benefits of LOQTORZI.

    當然。就推廣敏感度而言,LOQTORZI 對推廣非常敏感,因為我們的挑戰在於社區端醫師通常會看 10 到 15 種不同的癌症類型,他們不會「看到 LOQTORZI」,他們一年可能只會看到一到兩位 NPC 病患。因此必須持續提醒他們 LOQTORZI 以及 LOQTORZI 的效益。

  • I'll say this, when we do promote LOQTORZI to a physician, when we present the efficacy data, almost always we get complete buy-in about using LOQTORZI for the appropriate patients. Again, highly promotion sensitive, and we see a lot of opportunity to drive further growth. Does that answer your question, Jay?

    我想說的是,當我們向醫師推廣 LOQTORZI、並呈現療效數據時,幾乎總是能獲得他們對於在適當病患使用 LOQTORZI 的完全認同。再次強調,它對推廣高度敏感,我們也看到很大的機會可推動進一步成長。Jay,這樣有回答到你的問題嗎?

  • Jay Olson - Analyst

    Jay Olson - Analyst

  • Yes. And I guess maybe just any details you could provide on the additional investments in commercial infrastructure. Would that include field force expansion?

    有。我想再請教一下,你們能否提供任何關於商業基礎建設額外投資的細節?其中是否包含擴編外勤團隊?

  • Sameer Goregaoker - Chief Commercial Officer

    Sameer Goregaoker - Chief Commercial Officer

  • Yes. So we did do a modest field force expansion about a quarter ago that we announced. We did a 15% expansion in the live sales force. Now we're adding about four inside sales representatives to expand our reach into tier two targets. As I mentioned in my prepared remarks, we're also adding a VA-targeted contract sales force to focus on the Veterans Affairs business. That's the expansion we've done in a very targeted and focused manner.

    是的。我們在大約一季前確實做了小幅的外勤擴編,並已對外宣布。我們將第一線銷售團隊擴增了 15%。現在我們還要新增約四位內勤銷售代表,以擴大我們對第二層級目標客戶的觸及。如我在事先準備的發言中提到,我們也會新增一支針對 VA 的合約銷售團隊,專注於退伍軍人事務(Veterans Affairs)業務。這些擴編都是以非常有針對性且聚焦的方式進行。

  • Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

    Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

  • The other area of investments, Jay, is our information technology infrastructure. Because this is a rare disease, we feel that we need to make all efforts to capture as many of the patients as we can. Last year, we captured about 30% to 35% of the diagnosis code alerts. This year, we've expanded that to about 65% to 70%. We have also made investments in our display technology for the dashboards for the sales team.

    另外一個投資領域,Jay,是我們的資訊科技基礎建設。因為這是一種罕見疾病,我們認為需要盡一切努力捕捉到盡可能多的病患。去年我們大約捕捉到 30% 到 35% 的診斷碼警示。今年我們已將其擴大到約 65% 到 70%。我們也投資了展示技術,用於銷售團隊儀表板的呈現。

  • Further, as Sameer just alluded to, we have the inside sales force, which is also organizing and pursuing these alerts. I would just -- yes, I would just make one closing remark. We believe all these are appropriate in the context of driving to the potential $175 million annualized sales per year, which we think is important for us to do as soon as possible.

    此外,正如 Sameer 剛才提到的,我們有內勤銷售團隊,也在整理並追蹤這些警示。我想——是的——我想做一個結語。我們相信,為了推動年化 1.75 億美元的銷售潛力,這些投入都是恰當的,而我們認為越快達成越重要。

  • Jay Olson - Analyst

    Jay Olson - Analyst

  • Super helpful. If I could ask one more question on Tagmo, can you just talk about any plans for exploring a triple combination? I know J&J just reported phase I combo data for pasritamig and docetaxel. How are you thinking about adding Tagmo into that for a triple combo in prostate cancer?

    非常有幫助。如果我可以再問一個關於 Tagmo 的問題:你們能談談是否有計畫探索三重合併療法嗎?我知道 J&J 剛公布了 pasritamig 與 docetaxel 的第一期合併數據。你們如何思考在前列腺癌中把 Tagmo 加入其中,形成三重合併?

  • Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

    Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

  • Dr. Lavallee?

    Lavallee 醫師?

  • Theresa Lavallee - Chief Development Officer

    Theresa Lavallee - Chief Development Officer

  • Yes. No, I think that maximizing patient benefit in CRPC is what we're looking for. Clearly watching the results of those studies. I think we'll take the first step, which is the prudent step of putting the two drugs together to see what the contribution of effect is, the safety, the efficacy, and then if it's possible to move up into earlier lines through other combinations that would be of interest.

    是的。不,我想我們追求的是在 CRPC 中將病患受益最大化。我們當然會密切關注那些研究的結果。我認為我們會先採取第一步,也就是審慎地先把兩個藥物合併,看看效果貢獻、安全性與療效,然後再評估是否能透過其他有興趣的組合,往更早期治療線別推進。

  • Operator

    Operator

  • Mike Nedelcovych, TD Cowen.

    Mike Nedelcovych,TD Cowen。

  • Michael Nedelcovych - Equity Analyst

    Michael Nedelcovych - Equity Analyst

  • I have two. My first is on casdozokitug. I believe the frontline HCC trial is randomized but not blinded. So I'm curious if you're tracking responses? And if so, is what you're seeing giving you more or less confidence in casdozo's outlook. That's my first question. And then my second question relates to Tagmokitug. You have a wealth of data coming mid this year in various tumor types.

    我有兩個問題。第一個是關於 casdozokitug。我相信一線 HCC 試驗是隨機分派但未盲測。所以我想了解你們是否在追蹤反應?如果有,你們目前看到的情況,是否讓你們對 casdozo 的前景更有信心或更沒信心?這是我的第一個問題。第二個問題與 Tagmokitug 有關。你們在今年年中會在多種腫瘤類型上有大量數據出爐。

  • So I'm just curious how you're planning to disclose those data. Will we get press releases kind of indication by indication, one lump release of data across the solid tumor trial? How do you plan to disclose this data.

    所以我想請教你們打算如何揭露這些數據。我們會看到依適應症逐一發布新聞稿,還是會把整個實體腫瘤試驗的數據一次整包發布?你們打算如何披露這些數據?

  • Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

    Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

  • Thanks, Mike. I'll let Dr. Dias take those two questions for you. Rosh, would you like to answer the casdozo and then the Tagmo data questions.

    謝謝,Mike。我請 Dias 醫師來回答你這兩個問題。Rosh,你願意回答 casdozo 以及 Tagmo 數據的問題嗎?

  • Rosh Dias - Chief Medical Officer

    Rosh Dias - Chief Medical Officer

  • Sure. Mike, thanks for the question. So in response to your first question on Casdozokitug, obviously these are ongoing trials. These are open labels, but obviously because they are ongoing trials, we will report them when they are mature. What I will remind you is that for the previous Atezo Bev Casdozokitug study. You know, I outlined the top line results in my prepared remarks.

    當然。Mike,謝謝你的問題。針對你第一個關於 Casdozokitug 的問題,顯然這些都是進行中的試驗。這些是開放標籤,但因為仍在進行中,我們會在數據成熟時再行報告。我也提醒你,先前的 Atezo Bev Casdozokitug 研究,你知道,我已在事先準備的發言中概述了主要結果。

  • We did see a maturation of data with time in terms of an increase in response rate and a deepening of the response. Again, Casdozokitug, ongoing study, no further comments at this stage on that. In terms of the Tagmokitug question, your question is essentially how will we be reporting them? You know, again, as I said in my prepared remarks, there are really two determinants of data availability, the number of patients and then the numbers of scans.

    我們確實看到隨著時間推移,數據逐漸成熟,表現在反應率提升以及反應加深。再次強調,Casdozokitug 仍在進行中的研究,現階段對此沒有進一步評論。至於 Tagmokitug 的問題,你的問題本質上是我們將如何對外報告這些數據?你知道,如同我在事先準備的發言中所說,數據可用性主要由兩個因素決定:病患人數,以及掃描次數。

  • These will differ by the different tumor types and the different programs. What that essentially means is that it's not easy to predict the exact timing, right? Fundamentally, there are two scenarios. Either the timing aligns to the submission deadlines for a congress or it doesn't. If it's the former, we will release it at a congress. If it doesn't, we will essentially release by corporate disclosure.

    這些會因不同腫瘤類型與不同專案而有所差異。這基本上意味著,很難精準預測確切時點,對吧?從根本上說,有兩種情境。要嘛時點剛好符合某個學術會議的投稿截止日,要嘛不符合。如果是前者,我們會在會議上發布。如果不是,我們基本上會透過公司資訊揭露來發布。

  • I'll just remind you that we do have a, like, a track record of releasing data as it becomes available. I'll refer you to the AACR data last year. That would be our kind of high-level plan.

    我再提醒一下,我們確實有一個慣例:數據一旦可用就會發布。我請你參考我們去年在 AACR 發布的數據。那會是我們高層次的規劃。

  • Operator

    Operator

  • Colleen Kusy, Baird.

    Colleen Kusy,Baird。

  • Colleen Kusy - Analyst

    Colleen Kusy - Analyst

  • Congrats on the progress. Maybe a follow-up on the casdozo frontline HCC study to start. Understanding those data will continue to mature over time, but can you give us a sense of what you think that maturation timeline is, and how many of those patients that you'll report in this initial, readout will be in that mature window? Is there a bar at this kind of early readout that you'd be hoping to set?

    恭喜進展。我想先就 casdozo 一線 HCC 研究追問一下。我理解這些數據會隨時間持續成熟,但你能否讓我們了解你認為成熟的時間軸大概是什麼,以及在這次初步讀出中,你們將報告的病患中有多少會落在那個成熟窗口?在這種較早期的讀出上,你們希望設定一個什麼樣的門檻嗎?

  • Rosh Dias - Chief Medical Officer

    Rosh Dias - Chief Medical Officer

  • Yes. So let me unpack that a little bit. So your first question in terms of what we will be expecting, what we'd want to do is really have an overall response rate over what we saw previously in terms of the current standard of care. I'll remind you that was around 30% for the Atezo/Bev alone combination. The maturation time period for our previous study was somewhere between 6- to 12-months, right?

    是的。我來稍微拆解一下。你第一個問題關於我們預期會看到什麼、我們想要做到什麼,我們真正希望的是整體反應率能高於先前在現行標準治療下所看到的水準。我提醒你,單用 Atezo/Bev 組合大約是 30% 左右。我們先前研究的成熟時間大約介於 6 到 12 個月之間,對吧?

  • So there were several different data cuts. And over those three data cuts over that kind of 6-, 9-, 12-month period, there was an increase in response rate and a deepening of the response. So that's really, again, what we would expect. In terms of the numbers of patients, and what data we will be likely to report, that's a bit of a tough one to comment on exactly, primarily because of what I said in my prepared remarks, right?

    所以有幾個不同的數據截點。在那大約 6、9、12 個月期間的三個數據截點中,反應率有所提升,且反應也更深。所以這就是我們同樣會預期看到的情況。至於病患人數以及我們可能會報告哪些數據,這點要精準評論有點困難,主要原因就是我在事先準備的發言中提到的,對吧?

  • There are two determinants. It's how patients are accrued, but also the numbers of scans that were reported out. We will continue to report that out as we as we know. What I will say is that I think we'll have enough patients with enough scans to give an indication of early activity around mid-year timeframe as we've communicated previously.

    有兩個決定因素。一是病患入組的速度,二是已回報的掃描次數。我們會在掌握情況後持續對外更新。我能說的是,我認為我們會有足夠的病患與足夠的掃描,能在我們先前溝通過的年中時間點左右,提供早期活性的一些指標。

  • Colleen Kusy - Analyst

    Colleen Kusy - Analyst

  • Great. That's helpful. And then if you could just kind of walk us through what you're viewing as some of the important updates on the competitive front for CCR8 this year and how that might impact your development strategy going forward?

    很好。這很有幫助。另外,你能否帶我們梳理一下你認為今年在 CCR8 競爭面有哪些重要更新,以及這可能會如何影響你們後續的開發策略?

  • Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

    Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

  • Thanks for the question, Colleen. Will let Dr. Lavallee address that. Theresa any comments on the competitive dynamic in the CCR expense?

    謝謝你的問題,Colleen。我會請 Lavallee 醫師來回答。Theresa,對於 CCR8 領域的競爭態勢有什麼看法嗎?

  • Theresa Lavallee - Chief Development Officer

    Theresa Lavallee - Chief Development Officer

  • Yes. I mean, I think we expect to see the bookends of more data disclosures would be the positive and seeing updates from the programs, particularly from some of the big players that have upwards close to 1,000 patients on their study. We would anticipate -- I mean, what I'll note for BMS is that they, in the last two, JPMorgan have had CCR8 on their launch map by the end of the decade. We may see other programs being parked because of molecule issues.

    有的。我的意思是,我認為我們預期會看到更多數據揭露的兩端:一端是正面的結果,另一端是各項計畫的更新,特別是一些大型玩家,他們的研究入組病患數接近甚至超過 1,000 人。我們預期——我想我會特別指出 BMS,他們在最近兩次的摩根大通會議上,都把 CCR8 放在他們於本十年末前的上市規劃圖上。我們也可能看到其他計畫因分子本身的問題而被擱置。

  • Rosh Dias - Chief Medical Officer

    Rosh Dias - Chief Medical Officer

  • Colleen, just one additional point I wanted to also mention in terms of data availability. Obviously I've said this before and I'll repeat it, we are not just looking at ORR alone. you know, durability is important, safety is important, and overall clinical benefit rate is important. It's that really that kind of totality of data that we'll be looking at as we move through the program.

    Colleen,我還想補充一點關於數據可用性。顯然我之前說過,我再重申一次,我們不只看 ORR。你知道,持久性很重要,安全性很重要,整體臨床獲益率也很重要。我們在推進專案時,會看的是這種「整體數據」的全貌。

  • Colleen Kusy - Analyst

    Colleen Kusy - Analyst

  • And then last one, if I can, just, congrats again on the recent J&J deal. Just thinking about what for the next BD deals, what you might find most attractive for Tagmo. Would you stay within the T-cell engagers or what would be most appealing to you there?

    最後一個問題,如果可以的話,再次恭喜你們最近與 J&J 的合作。在思考下一個 BD 合作時,對 Tagmo 而言你們會覺得什麼最具吸引力?你們會維持在 T 細胞銜接器(T-cell engagers)領域內,還是什麼會是你們最想要的方向?

  • Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

    Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

  • Well, as we mentioned in our prepared remarks, one of the very interesting things that's so promising about Tagmokitug is the potentially broad application of the mechanisms of action across modalities, whether it be ADCs, T-cell engagers, radiation. As Dr. Lavallee indicated in her prepared remarks, a lot of cancer therapies result in greater Treg generation. We think it's very broad and we, I think we'll focus on doing additional arrangements with other parties and see what we can get done so far this year.

    嗯,正如我們在事先準備的發言中提到的,Tagmokitug 非常有趣且很有前景的一點,是其作用機制可能可跨不同治療形式廣泛應用,無論是 ADC、T 細胞銜接器,或放射治療。如 Lavallee 醫師在她的事先準備發言中指出,許多癌症治療會導致更多 Treg 生成。我們認為這個機制的適用面非常廣,我想我們會專注於與其他夥伴進一步洽談合作安排,看看今年到目前為止能推進到什麼程度。

  • Operator

    Operator

  • Brian Cheng, JPMorgan.

    Brian Cheng,JPMorgan。

  • Brian Cheng - Analyst

    Brian Cheng - Analyst

  • Just for Tagmo, how should we think about the strategy to develop your prostate cancer combo here with Pasri, in terms of the priority, given your hands is currently in multiple indications today?

    就 Tagmo 而言,我們應該如何看待你們在前列腺癌與 Pasri 的聯合治療開發策略與優先順序,考量到你們目前已在多個適應症同步推進?

  • Theresa Lavallee - Chief Development Officer

    Theresa Lavallee - Chief Development Officer

  • Yes. I think all the studies are executable. I mean, I think really getting the data across the tumor types that have a strong scientific rationale for a high degree of target expression with different immune contexts is our priority. I mean, given the prevalence and the need in CRPC, I mean, those studies should enroll relatively quickly. It could be a very exciting indication to look at. It's equally important to all the other ones.

    是的。我認為所有研究都具備可執行性。我的意思是,我們的優先事項其實是取得跨不同腫瘤類型的數據:這些腫瘤類型在科學上有很強的理據,顯示目標表達程度高,且免疫微環境各不相同。再者,考量到 CRPC 的盛行率與未滿足需求,這些研究應該能相對快速入組。這可能會是一個非常令人興奮、值得觀察的適應症。它與其他適應症同樣重要。

  • We're really looking for the data to learn. As Rosh and I have talked about in the past, our program is very intentional to learn the best context for how to use Tagmokitug, and now not just with toripalimab, but also with the T-cell engager.

    我們真正是在看數據來學習。如同我和 Rosh 過去談過的,我們的專案設計非常有目的性,是為了學到使用 Tagmokitug 的最佳情境,而現在不僅是與 toripalimab 聯用,也包括與 T 細胞銜接器聯用。

  • Brian Cheng - Analyst

    Brian Cheng - Analyst

  • As you think about the bar for mCRPC here, what would you want to see in this third line plus setting, in terms of PSA50 endpoint?

    當你思考這裡 mCRPC 的門檻時,在三線以上治療情境下,就 PSA50 終點而言,你希望看到什麼?

  • Rosh Dias - Chief Medical Officer

    Rosh Dias - Chief Medical Officer

  • Yes. I mean, a couple of points I'll say. You know, as I said in my prepared remarks, we'll be looking at safety as well as PSA50, so both will be important. I won't comment too much on expectations at this stage, but what I will say is if you look at the current, the current treatment environment for PSA50 it really goes. It drops dramatically after the second line, right?

    是的。我想我會說幾點。你知道,如同我在事先準備的發言中提到的,我們會看安全性以及 PSA50,所以兩者都很重要。我現階段不會對預期多做評論,但我想說的是,如果你看目前 PSA50 的治療環境,它在二線之後會大幅下降,對吧?

  • First line can go up to about it's around 70% or up to 70% in terms of PSA50. When you get to second line, it's in the 45% range. When you get to third line, it's around the 20% or less stage. Those are really kind of the current benchmarks. Further than that, I won't comment until we start opening up the study, which we anticipate to be in the second half of this year.

    一線治療的 PSA50 大約可達 70% 或接近 70%。到了二線,大約在 45% 左右。到了三線,大約在 20% 或更低。這些大致就是目前的基準。除此之外,在我們開始啟動研究之前我不會再多評論;我們預期會在今年下半年開啟該研究。

  • Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

    Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

  • Brian, I think this is Denny. I think you can look forward to having a little more comment on this study, on the August call, which we'll report Q2, given the fact that we anticipate initiating it in the second half of the year.

    Brian,我想這是 Denny。我想你可以期待在 8 月的電話會議上,針對這項研究會有更多一些評論;屆時我們將公布第二季(Q2)結果,因為我們預期會在今年下半年啟動它。

  • Operator

    Operator

  • (Operator Instructions) Douglas Tsao, HC Wainwright.

    (接線員指示) Douglas Tsao,HC Wainwright。

  • Doug Tsao - Analyst

    Doug Tsao - Analyst

  • Denny, I think it was you said that around $35 million the revenue level you sort of basically become sort of cash flow breakeven, excluding R&D. I guess how -- you made a comment sort of that R&D was discretionary or sort of you had a -- not discretionary, but you sort of had sort of ability to make choices where you're spending the money and how much.

    Denny,我想是你提到,大約在 3,500 萬美元的營收水準時,基本上就會接近現金流損益兩平(不含研發)。我想問的是——你有提到研發是可選擇的,或是你有——不是說可有可無,但你在資金花在哪裡、花多少方面,似乎有一定的選擇空間。

  • I guess maybe if you could just help us with the framework in terms of what you think is an appropriate level of R&D spend, and how do you find that balance between sort of the revenues that you're bringing in versus maybe needing some additional outside capital to fund the R&D program, just given the fact that the aperture of opportunities for the company seems to have been expanding quite nicely.

    我想也許你可以幫我們建立一個框架:你認為適當的研發支出水準應該是多少?以及你如何在帶進來的營收,與可能需要額外外部資金來支持研發計畫之間取得平衡?畢竟公司可把握的機會窗口看起來正在相當不錯地擴大。

  • Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

    Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

  • Thanks, Doug. Let me try to frame our view and provide you a lens through which to view the budgetary considerations. You know, firstly, as I indicated, with the commercial team, the commercial spend includes the commercial team itself, all the commercial spends, the computer systems, the IT spends, whatever the sales force needs. Also royalties, for example, there's a 20% royalty to Junshi.

    謝謝,Doug。我試著整理我們的看法,並提供你一個用來看待預算考量的視角。你知道,首先,如我所說,商業團隊方面,商業支出包含商業團隊本身、所有商業相關支出、電腦系統、IT 支出,以及銷售團隊所需的一切。另外還有權利金,例如要付給君實(Junshi)20% 的權利金。

  • There's COGS. I characterize all that as sort of the spend to get the sales. That is probably $15 million, $16-ish million a quarter. Regarding the other spends the $30 million to $35 million, that includes carrying also those same commercial spends with the increased COGS because of increased sales. Also the internal SG&A, the rest of the headcount in the company and so on.

    還有銷貨成本(COGS)。我把這些都歸類為「為了取得銷售而必須花的支出」。這大概每季是 1,500 萬到 1,600 萬美元左右。至於另外提到的 3,000 萬到 3,500 萬美元的支出,則也包含同樣的商業支出,並因銷售增加而帶來更高的銷貨成本。也包含公司內部的 SG&A、公司其餘人力編制等等。

  • In fact, everything except what I would characterize as additional development or clinical trial costs. Those we view in a separate bucket, and I would put those in bucket number three. And so when we initiated the development of the assets post the Biosimilar spin out we had $250 million, and we were moving forward, and we identified a series of trials that we wanted to do.

    事實上,除了我會歸類為額外開發或臨床試驗成本的項目之外,其他都包含在內。那些我們會放在另一個獨立的桶子裡,我會把它們放在第三個桶子。因此,在生物相似藥(Biosimilar)分拆之後,我們啟動資產開發時手上有 2.5 億美元,我們持續推進,並且辨識出一系列我們想要進行的試驗。

  • What we had done since then, of course, we did expand that a bit. We we feel that it's very strategically worthwhile to pursue the engagement with J&J with prostate. We also think that CRC is an area of unmet medical need. For the time being, we feel we're clearly funded for the clinical trials that we've done. As Tagmokitug, as Dr. Lavallee recited to you, has very broad potential applicability.

    當然,從那之後我們確實又把範圍稍微擴大了一些。我們認為在前列腺癌方面與 J&J 的合作推進,在策略上非常值得。我們也認為大腸直腸癌(CRC)是未被滿足醫療需求的領域。就目前而言,我們認為我們已明確具備資金來支持已進行的臨床試驗。正如 Tagmokitug、以及 Lavallee 醫師向各位說明的,它具有非常廣泛的潛在適用性。

  • On the other hand, I think that we've shown ourselves to be very judicious and thoughtful with our spends, and we'll continue to do so. You know, we want to understand the mechanism of action. We want to understand really where it works and why it works and place our bets there. I think that overall, we've positioned the company well for the future.

    另一方面,我想我們已經證明自己在支出上非常審慎且深思熟慮,我們也會持續如此。你知道,我們想了解作用機轉。我們想真正了解它在哪裡有效、為什麼有效,並把賭注下在那些地方。我認為整體而言,我們已為公司的未來做好良好布局。

  • As you've known us a long time, we keep a pretty sharp eye on our finances. And lastly, I think that our track record with core over the past couple of years, particularly the doubling of revenues, '25 over '24 gives us a fair degree of confidence that we'll be able to march it up to of $175 million as annualized sales in 2028. And as I pointed out, sign post along the way are some $15 million or $16 million were the commercial team pays for itself and then on to 30-plus square be carrying the rest of the company.

    如你們長期以來所了解的,我們對財務狀況一直保持相當嚴密的關注。最後,我認為我們過去幾年在核心業務上的紀錄,特別是營收翻倍,以及 2025 年相較 2024 年的成長,讓我們相當有信心能在 2028 年把年化銷售額推進到 1.75 億美元。而如我所指出的,沿途的里程碑包括:大約 1,500 萬或 1,600 萬美元時,商業團隊就能自給自足;接著到 3,000 萬以上,則可以負擔公司其餘的營運。

  • And that's the fundamental role of Lavori really, is to pay for all those things for us so we can develop the drugs. And that's the lens through which we view it.

    而 Lavori 的根本角色其實就是替我們支付所有這些項目,讓我們能夠開發藥物。這就是我們看待此事的視角。

  • Doug Tsao - Analyst

    Doug Tsao - Analyst

  • Okay, Denny, that's really helpful. Just maybe a follow-up for Sameer. Just what is the current duration of therapy for patients on LOQTORZI right now? I mean, I think you sort of indicated, that you expected to see an increase in the number of new patients start. I'm just curious how much of an opportunity is there for you to see an improvement on the persistence equation?

    好的,Denny,這非常有幫助。再追問一下 Sameer。目前使用 LOQTORZI 的病人,治療持續時間大概是多久?我的意思是,我想你有提到你預期會看到開始治療的新病人數增加。我只是好奇,在治療持續性(persistence)這個面向,你們還有多大的改善空間?

  • Sameer Goregaoker - Chief Commercial Officer

    Sameer Goregaoker - Chief Commercial Officer

  • Yes. Thanks for the question. So just to remind you, there's two types of indications we have. We've got a frontline indication in a locally advanced recurrent setting and the frontline metastatic. We also have the second line metastatic and third line metastatic indications. The duration of therapy in the second line indication should be much shorter than the frontline indication.

    是的。謝謝你的問題。先提醒一下,我們有兩種類型的適應症。我們有一線適應症:局部晚期復發情境的一線,以及轉移性的一線。我們也有二線轉移性與三線轉移性的適應症。依據臨床試驗,二線適應症的治療持續時間應該會比一線適應症短得多。

  • That's kind of the basic assumption from the clinical trials. That being said, we look at the duration of therapy every three-months looking at claims data. The duration of therapy continues to grow every time we look at it. I'm still not ready to give you a number on the average duration of therapy, because we simply don't have enough patients and cohorts to look at an average number.

    這算是從臨床試驗得出的基本假設。話雖如此,我們每三個月會透過理賠(claims)資料來檢視治療持續時間。每次我們檢視時,治療持續時間都在增加。我目前還不準備給你平均治療持續時間的數字,因為我們的病人數與可用的分群(cohorts)還不夠,無法計算出具代表性的平均值。

  • What I can say is the duration continues to increase, and we still have room to grow from where we are today to where the clinical trial duration was. To answer the other implied question you had, the contribution from the existing patients and the contribution from new patients will continue to both grow as we go through the next couple of years.

    我能說的是,治療持續時間仍在增加,而且從目前的水準到臨床試驗中的治療持續時間之間,我們仍有成長空間。回應你另一個隱含的問題:在未來幾年,既有病人的貢獻與新病人的貢獻都會持續成長。

  • Operator

    Operator

  • Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.

    謝謝。今天的電話會議到此結束。感謝各位參與。您現在可以掛線。