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Operator
Operator
Good day, and welcome to the OPKO Health first quarter 2026 financial results conference call. (Operator Instructions) Please note this event is being recorded.
大家好,歡迎參加 OPKO Health 2026 年第一季財務業績電話會議。(接線員指示) 請注意,本活動將被錄音。
I would now like to turn the conference over to Yvonne Briggs. Please go ahead.
現在我想把會議交給 Yvonne Briggs。請開始。
Yvonne Briggs - Investor Relations
Yvonne Briggs - Investor Relations
Thank you, operator, and good afternoon. This is Yvonne Briggs with Alliance Advisors IR. Thank you all for joining today's call to discuss OPKO Health's financial results for the first quarter of 2026.
謝謝,接線員,大家午安。我是 Alliance Advisors IR 的 Yvonne Briggs。感謝各位參加今天的電話會議,一同討論 OPKO Health 2026 年第一季的財務業績。
I'd like to remind you that any statements made during this call by management other than statements of historical fact will be considered forward-looking and as such, are subject to risks and uncertainties that could materially affect the company's results. Those forward-looking statements include, without limitation, the various risks described in the company's SEC filings, including the annual report on Form 10-K for the year ended December 31, 2025.
我想提醒各位,本次電話會議中管理層所作的任何陳述,除歷史事實陳述外,均將被視為前瞻性陳述,因此可能受到風險與不確定性影響,並可能對公司業績造成重大影響。該等前瞻性陳述包括但不限於公司向 SEC 提交文件中所述的各項風險,包括截至 2025 年 12 月 31 日止年度的 Form 10-K 年度報告。
Furthermore, this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, April 28, 2026. Except as required by law, OPKO undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this call.
此外,本次電話會議包含具時效性的資訊,僅在直播日期(2026 年 4 月 28 日)當日為準確。除法律要求外,OPKO 不承擔任何義務對任何前瞻性陳述進行修訂或更新,以反映本次電話會議日期之後發生的事件或情況。
Regarding the format of today's call, Dr. Phillip Frost, Chairman and Chief Executive Officer, will provide opening remarks. Dr. Elias Zerhouni, Vice Chairman and President, will then provide an overview of OPKO's Therapeutics segment as well as BioReference Health. After that, Adam Logal, OPKO's CFO, will review the company's first quarter financial results and discuss OPKO's financial outlook, and then we'll open the call to questions.
關於今天電話會議的流程,董事長兼執行長 Phillip Frost 醫師將先發表開場致詞。接著,副董事長兼總裁 Elias Zerhouni 醫師將概述 OPKO 的治療事業部門以及 BioReference Health。之後,OPKO 財務長 Adam Logal 將回顧公司第一季財務結果並討論 OPKO 的財務展望,然後我們將開放提問。
Now I'd like to turn the call over to Dr. Frost.
現在我想把電話會議交給 Frost 醫師。
Phillip Frost - Chairman of the Board, Chief Executive Officer
Phillip Frost - Chairman of the Board, Chief Executive Officer
Thank you for joining us today. During the first quarter, we made meaningful progress with our strategic initiatives with particular emphasis on advancing our ModeX product development pipeline. ModeX now has five programs in the clinic, spanning vaccines, oncology and immunology, all with the potential to be first and best-in-class in their therapeutic areas. Days after the close of the first quarter, we dosed our first subjects in the Phase I clinical trial of MDX2301, our BARDA-funded multispecific antibody for the prevention of COVID in high-risk populations.
感謝各位今天加入我們。在第一季,我們在策略性計畫上取得了具意義的進展,特別著重於推進我們的 ModeX 產品研發管線。ModeX 目前有五個臨床階段計畫,涵蓋疫苗、腫瘤學與免疫學,皆有潛力在其治療領域成為同類首創且同類最佳。在第一季結束後數日,我們於 MDX2301 的第一期臨床試驗中完成首批受試者給藥;MDX2301 是我們獲 BARDA 資助、用於在高風險族群預防 COVID 的多特異性抗體。
Shortly thereafter, we announced the dosing of the first patient in the Phase I trial to evaluate MDX2003, a tetraspecific T-cell engager in patients with relapsed or refractory B-cell lymphoma. We also continue to advance our other oncology candidates in clinical development, MDX2001, a tetraspecific T-cell engager targeting solid tumors and MDX2004, a multispecific immune rejuvenator. Over the course of this year, we expect ModeX to achieve a number of clinical and partnership milestones as these programs progress and in the case of our EBV vaccine approach later-stage development with our partner, Merck.
不久之後,我們宣布在第一期試驗中完成首位病患給藥,以評估 MDX2003;MDX2003 是一款四特異性 T 細胞接合器,用於復發或難治性 B 細胞淋巴瘤患者。我們也持續推進其他處於臨床開發階段的腫瘤候選藥物,包括 MDX2001(針對實體腫瘤的四特異性 T 細胞接合器)以及 MDX2004(多特異性免疫回春劑)。在今年期間,隨著這些計畫推進,以及我們的 EBV 疫苗策略與合作夥伴默克(Merck)進入較後期開發,我們預期 ModeX 將達成多項臨床與合作里程碑。
Our collaboration with Regeneron is progressing well as we align their extensive antibody binder libraries with our multispecific engineering platform across various indications in metabolism, oncology and immunology. This collaboration is another example of strategic partnerships that are a good source of nondilutive capital to support our R&D efforts. The potential total value of the Regeneron collaboration exceeds $1 billion in milestones plus future royalties.
我們與 Regeneron 的合作進展順利,我們正將其龐大的抗體結合子(binder)資料庫與我們的多特異性工程平台對接,涵蓋代謝、腫瘤學與免疫學等多項適應症。此合作是策略性夥伴關係的另一例證,可作為支持我們研發投入的非稀釋性資金來源。與 Regeneron 合作的潛在總價值超過 10 億美元的里程碑款,另加未來權利金。
In our Diagnostics business, Q1 reflects our second full quarter with the new BioReference footprint following our oncology divestiture. We're now centered on our core regional clinical laboratory operations in New York and New Jersey, our correctional health business and our national specialty urology testing franchise anchored by the 4Kscore test. We continue to streamline our infrastructure and cost base to achieve profitable growth from this segment.
在我們的診斷業務方面,第一季反映了我們在出售腫瘤業務後、採用新 BioReference 版圖的第二個完整季度。我們目前聚焦於核心的區域臨床實驗室營運(位於紐約與新澤西)、矯正機構醫療業務,以及以 4Kscore 檢測為核心的全國性泌尿專科檢測業務。我們持續精簡基礎設施與成本結構,以在該事業部門實現獲利性成長。
We closed the quarter with a solid cash balance. This reflects past asset sales, continued R&D support from our partners and contributions from our international Pharmaceutical operations. This financial strength enables us to fund our R&D portfolio at a meaningful level and to return capital to shareholders through our stock repurchase program.
本季結束時,我們維持穩健的現金餘額。這反映了過往資產出售、合作夥伴持續提供的研發支持,以及我們國際製藥業務的貢獻。這樣的財務實力使我們能以具規模的水準資助研發組合,並透過股票回購計畫向股東返還資本。
With that overview, I'll turn the call over to Elias.
以上為概述,接下來我把電話會議交給 Elias。
Elias Zerhouni - President, Vice Chairman of the Board
Elias Zerhouni - President, Vice Chairman of the Board
Well, thank you, Phil, and good afternoon, everyone. Let me start with the biopharma side of our business because that's where we're making tremendous progress advancing our pipeline right now. As Dr. Frost said, we now have five assets in the clinic and expect an additional program for our in vivo CAR-T cell platform to commence first-in-human clinical trials this year.
謝謝你,Phil,各位午安。我先從我們業務中的生物製藥面向談起,因為我們目前在推進研發管線方面正取得巨大的進展。如 Frost 醫師所說,我們現在有五項資產處於臨床階段,並預期今年將有一項針對體內(in vivo)CAR-T 細胞平台的新增計畫啟動首次人體臨床試驗。
So let me review our programs and provide updates on each of them. Our collaboration with Merck is focused on the vaccine against Epstein-Barr virus that combines 4 EBV antigens developed by ModeX with Merck's adjuvants. In the Phase I trial, Merck enrolled over 200 subjects to evaluate safety, tolerability and immunogenicity and various subgroup studies and analysis are underway to understand the responses in EBV-naive subjects and patients as young as 12 years of age, which will be important for future studies.
接下來我將回顧我們的各項計畫並逐一提供最新進展。我們與默克(Merck)的合作聚焦於針對 Epstein-Barr 病毒(EBV)的疫苗,該疫苗結合了 ModeX 開發的 4 種 EBV 抗原與默克的佐劑。在第一期試驗中,默克已納入超過 200 名受試者以評估安全性、耐受性與免疫原性;目前也正在進行各項亞組研究與分析,以了解 EBV 未感染(EBV-naive)受試者以及最年輕至 12 歲患者的反應,這對未來研究將很重要。
So we expect Merck to have the data needed to inform a Phase II design by the end of this year with initiation of a Phase II clinical study anticipated next year, subject to Merck's decisions and announcements. Now for MDX2001, which is our lead immuno-oncology candidate for solid tumors, including head and neck, esophageal, pancreatic, lung and prostate cancers, MDX2001, as you know, is a tetraspecific T-cell engager directed at two tumor antigens, cMet and Trop2 and 2 T-cell activators, CD3 and CD28.
因此,我們預期默克將在今年年底前取得足以制定第二期試驗設計所需的資料;在符合默克的決策與公告前提下,預計明年啟動第二期臨床研究。接著談 MDX2001,這是我們針對實體腫瘤的領先免疫腫瘤候選藥物,涵蓋頭頸癌、食道癌、胰臟癌、肺癌與前列腺癌等;如各位所知,MDX2001 是一款四特異性 T 細胞接合器,靶向兩個腫瘤抗原 cMet 與 Trop2,以及兩個 T 細胞活化因子 CD3 與 CD28。
The goal is to drive a deeper and more durable response by simultaneously recognizing heterogeneous tumor antigen expression and providing both CD3 and CD28 activators and enhancers to T cells, thereby enhancing activation and T-cell survival. Enrollment in our Phase I study is continuing into 2 parallel cohorts to support dose escalation and optimize the dosing regimen. We have dosed more than 30 patients so far across multiple tumor types and have reached dose levels approximately tenfold higher than the starting dose, all with acceptable safety.
其目標是透過同時辨識腫瘤抗原表現的異質性,並向 T 細胞提供 CD3 與 CD28 兩種活化與增強訊號,以驅動更深且更持久的反應,從而增強活化並提升 T 細胞存活。我們的第一期研究持續招募中,並分為兩個平行隊列,以支持劑量遞增並最佳化給藥方案。截至目前,我們已在多種腫瘤類型中對超過 30 名患者完成給藥,且已達到約為起始劑量 10 倍的劑量水準,安全性皆可接受。
We plan to present Phase Ia data at a conference in the second half of this year. In addition, Phase Ib is expected to start later this year, focusing on the tumor types most likely to show signs of efficacy. We're also commencing work to enable subcutaneous formulations. For our next program, MDX2004, which is our first-in-class multispecific immune rejuvenator that simultaneously engages CD3, CD28 and 4-1BB to not only activate but also expand and sustain stem-like and memory T cells in the immune system.
我們計畫在今年下半年於一場會議上發表第一期 Ia 的數據。此外,預期第一期 Ib 將於今年稍晚啟動,聚焦於最可能顯示療效訊號的腫瘤類型。我們也正開始推動皮下劑型的開發工作。接著是我們的下一個計畫 MDX2004,這是同類首創的多特異性免疫回春劑,可同時結合 CD3、CD28 與 4-1BB,不僅活化免疫系統,亦能擴增並維持免疫系統中的幹樣(stem-like)與記憶 T 細胞。
Preclinical data has demonstrated that MDX2004 expands stem T cells, increases T-cell activation and stimulates proliferation of CD8 and CD4 memory subsets. And so these data support its potential as a pipeline in a product across cancers and chronic infections among the elderly and immune-impaired subjects. MDX2004 entered Phase I in the third quarter of last year, and we're currently in the dose escalation stage in heavily pretreated cancer patients.
臨床前數據顯示,MDX2004 可擴增幹樣 T 細胞、提高 T 細胞活化,並刺激 CD8 與 CD4 記憶亞群的增殖。因此,這些數據支持其作為一項產品管線的潛力,可應用於癌症以及老年與免疫功能受損受試者的慢性感染。MDX2004 已於去年第三季進入第一期臨床試驗,目前我們正處於在接受過多線治療的癌症患者中進行劑量遞增的階段。
The trial includes both PD-1 naive patients and patients previously treated with PD-1 inhibitors with the goal of determining whether immune rejuvenation can restore or prolong responses. Our objective this year is to complete Phase Ia, define an appropriate dosing schedule and prepare for expansion into select tumor types and longer term into broader immune impairment indications.
該試驗納入PD-1初治患者以及先前接受過PD-1抑制劑治療的患者,目標是判定免疫回春是否能恢復或延長反應。我們今年的目標是完成Ia期、界定適當的給藥時程,並為在特定腫瘤類型中的擴展以及長期拓展至更廣泛的免疫功能受損適應症做好準備。
Now our newest molecule in the clinic is MDX2003. It's our tetraspecific T-cell engager and expander targeting both CD19 and CD20 on B cells and CD3 and CD28 on T cells. The intent is to address tumor antigen heterogeneity and escape mechanisms, which we see with CD19 only or CD20 only approaches by maintaining activity even when one B-cell marker is lost, while CD28 co-stimulation supports sustained T-cell function. We recently initiated a Phase I trial in B-cell lymphomas and leukemias in Australia and Israel with additional sites to follow.
目前我們最新進入臨床的分子是MDX2003。這是我們的四特異性T細胞接合與擴增器,同時靶向B細胞上的CD19與CD20,以及T細胞上的CD3與CD28。其用意在於解決腫瘤抗原異質性與逃逸機制;我們在僅靶向CD19或僅靶向CD20的策略中會看到這些問題。透過在其中一個B細胞標記丟失時仍維持活性,同時藉由CD28共刺激支持持續的T細胞功能。我們近期已在澳洲與以色列啟動B細胞淋巴瘤與白血病的I期試驗,後續將增加更多試驗據點。
In parallel, we're evaluating the optimal path to explore autoimmune indications for MDX2003, which has the potential to play a role in autoimmunity. In March, ModeX presented 2 posters at the ESMO Targeted Anticancer Therapies Congress 2026 in Paris, further highlighting the breadth of our oncology portfolio. One presentation profiled MDX2004, describing the ongoing first-in-human trial in patients with advanced tumors and introducing the concept of immune rejuvenation as a differentiated approach to restoring antitumor immunity.
同時,我們也在評估探索MDX2003自體免疫適應症的最佳路徑,該藥物具有在自體免疫中發揮作用的潛力。3月,ModeX在巴黎舉行的ESMO Targeted Anticancer Therapies Congress 2026上發表了2張海報,進一步凸顯我們腫瘤產品組合的廣度。其中一項發表介紹了MDX2004,說明在晚期腫瘤患者中進行中的首次人體試驗,並提出「免疫回春」作為一種具差異化、用以恢復抗腫瘤免疫的策略概念。
The second was focused on MDX2003 and showcased its potent preclinical activity across multiple B-cell malignancy models and its potential relevance in autoimmunity. In addition to our own research, we're very pleased with the progress under our collaboration with Regeneron, which, as Dr. Frost mentioned, combines their extensive library of clinically validated monoclonal antibody binders with our modular multispecific architecture across immunology, oncology and metabolic diseases.
第二項則聚焦於MDX2003,展示其在多種B細胞惡性腫瘤模型中的強勁臨床前活性,以及其在自體免疫中的潛在相關性。除我們自身研究外,我們也對與Regeneron合作的進展感到非常滿意;如Frost博士所提及,該合作結合了他們龐大且經臨床驗證的單株抗體結合子庫,與我們在免疫學、腫瘤學與代謝疾病領域的模組化多特異性架構。
Together, the teams are focused on advancing four initial discovery program -- programs using the ModeX platform to rapidly generate and optimize multispecific antibody candidates with the potential to expand into additional targets over time. Regeneron is responsible for funding preclinical, clinical and commercial development of the selected assets, while OPKO is eligible for research, development, regulatory and commercial milestones that could exceed $1 billion as well as tiered royalties on global sales up to the low double digits.
雙方團隊正專注推進四個初始探索計畫——這些計畫使用ModeX平台快速產生並優化多特異性抗體候選物,並可隨時間推進擴展至更多標的。Regeneron負責為所選資產的臨床前、臨床及商業化開發提供資金;而OPKO則有資格獲得研究、開發、法規與商業化里程碑款項,總額可能超過10億美元,並可就全球銷售額取得分級權利金,最高可達低雙位數百分比。
Now moving to infectious diseases. MDX2301 is the first ModeX multispecific antibody program to enter the clinic under our collaboration with BARDA. MDX2301 is a tetravalent bispecific antibody that targets distinct and conserved regions of the SARS-CoV-2 spike receptor binding domain. And by -- it is designed for broad coverage and long duration of protection because it really attacks two separate regions of the virus, which prevents escape of the virus through mutations.
接著談傳染病。MDX2301是我們與BARDA合作下,首個進入臨床的ModeX多特異性抗體計畫。MDX2301是一種四價雙特異性抗體,靶向SARS-CoV-2刺突蛋白受體結合區域中不同且保守的區段。其設計旨在提供廣泛覆蓋與長效保護,因為它同時攻擊病毒的兩個獨立區域,從而防止病毒透過突變而逃逸。
The initial indications are prophylaxis in high-risk immunocompromised populations who cannot be protected by immunization, vaccination and used in post-exposure outbreak settings with potential expansion into acute treatment of COVID and the treatment of long COVID. To date, remarkably, this multispecific antibody has demonstrated high potency against all known variants of SARS-CoV-2 and continues to be effective against all circulating variants of the virus.
初始適應症包括:用於無法透過免疫接種或疫苗獲得保護之高風險免疫功能低下族群的預防;以及用於暴露後群聚疫情情境,並有潛力擴展至COVID急性治療與長新冠治療。迄今為止,值得注意的是,該多特異性抗體已對所有已知SARS-CoV-2變異株展現高效力,且仍對目前流行的所有病毒變異株保持有效。
We initiated the Phase I trial of MDX2301, which is evaluating safety and tolerability across different routes of administration and dosing regimens in healthy volunteers and in adults at high risk of severe COVID. And the first dose cohort is completed and BARDA is funding the program, including the clinical trial costs. BARDA is also supporting our multispecific influenza program, which targets conserved regions of hemagglutinin to enable broad coverage across influenza A and B strains.
我們已啟動MDX2301的I期試驗,評估其在健康志願者以及重症COVID高風險成人中,於不同給藥途徑與劑量方案下的安全性與耐受性。第一個劑量隊列已完成,且BARDA正在資助該計畫,包括臨床試驗成本。BARDA也在支持我們的多特異性流感計畫,該計畫靶向血凝素的保守區域,以實現對A型與B型流感株的廣泛覆蓋。
We're currently conducting pre-IND work using challenged models to select the lead clinical candidate and we expect this program to move closer to the commencement of clinical trials with the potential for additional financial support from BARDA.
我們目前正進行IND前工作,使用攻毒模型來選定領先的臨床候選物;我們預期該計畫將更接近啟動臨床試驗,並有機會獲得BARDA額外的財務支持。
To date, BARDA has committed over $100 million since the inception of these 2 programs. Now over the past several years, ModeX has also built a multimodal in vivo CAR-T and gene delivery platform that we believe is highly differentiated versus traditional ex vivo CAR-T approaches because it combines our unique multispecific technology with proprietary in vivo CAR technologies.
迄今為止,自這兩個計畫啟動以來,BARDA已承諾投入超過1億美元。此外,在過去幾年中,ModeX也建立了一個多模態的體內CAR-T與基因遞送平台;我們認為相較於傳統的體外(ex vivo)CAR-T方法,該平台具高度差異化,因為它將我們獨特的多特異性技術與專有的體內CAR技術結合。
Using lipid nanoparticles conjugated with cell-specific multispecific antibodies on the surface, we can deliver mRNA or DNA payloads, encoding CARs directly to specific immune cell subset, not only just T cells, but also B cells or NK cells to generate functional CAR-T cells in vivo at lower effective doses.
透過在脂質奈米粒子表面接合具細胞特異性的多特異性抗體,我們可將編碼CAR的mRNA或DNA載荷直接遞送至特定免疫細胞亞群,不僅是T細胞,也包括B細胞或NK細胞,以在體內生成具功能性的CAR-T細胞,且所需有效劑量更低。
Preclinical data has been obtained in humanized mice and nonhuman primates and a presentation of this work will be made at the ASGCT meeting in Boston next month. And we believe this technology offers several potential advantages that is, it is off-the-shelf, can be redosed and leverages our multispecific antibodies for cell-specific targeting and built-in activation via CD3/CD28. It also uses site-specific antibody conjugation and proprietary lipids to support manufacturability at scale and reduce off-target delivery to the liver.
我們已在人體化小鼠與非人靈長類取得臨床前數據,並將於下月在波士頓舉行的ASGCT會議上發表此項工作。我們相信此技術具備多項潛在優勢:可即取即用(off-the-shelf)、可重複給藥,並利用我們的多特異性抗體進行細胞特異性靶向,以及透過CD3/CD28內建活化。此外,它採用位點特異性抗體接合與專有脂質,以支持規模化製造,並降低對肝臟的非靶向遞送。
In nonhuman primate studies, we have shown proof-of-concept for in vivo CAR-T generation, deep B-cell depletion in blood and tissues and a favorable tolerability profile. These effects were achieved at doses that were a fraction of those reported for completing platforms -- for competing platforms, sorry. We're now in IND-enabling studies for our lead CD19-targeted in vivo CAR-T program and expect entry into the clinic by the end of this year or early 2027.
在非人靈長類研究中,我們已展示體內生成CAR-T的概念驗證、血液與組織中的深度B細胞耗竭,以及良好的耐受性概況。這些效果是在遠低於競爭平台所報告的劑量下達成——抱歉,是相較於競爭平台。我們目前正針對領先的CD19靶向體內CAR-T計畫進行IND支持性研究,並預期於今年底或2027年初進入臨床。
Now turning to our endocrine and metabolic programs. We continue to advance our subcutaneous injection formulation of OPKO 88006 (sic - OPK-88006) for the treatment of MASH. OPK-88006 is an analog of the natural GLP-1 glucagon hormone, oxyntomodulin. And we're planning a first-in-human single ascending dose and multiple ascending dose Phase I/IIa clinical study with data expected by the second half of 2027.
接著談我們的內分泌與代謝計畫。我們持續推進OPKO 88006(原文如此—OPK-88006)的皮下注射劑型,用於治療MASH。OPK-88006是天然GLP-1/胰高血糖素激素——氧胰高血糖素(oxyntomodulin)的類似物。我們正規劃一項首次人體單次遞增劑量與多次遞增劑量的I/IIa期臨床研究,預計於2027年下半年取得數據。
The findings will be used to guide the further development of our oral oxyntomodulin in partnership with Entera Bio. We also recently expanded our relationship with Entera to include a third joint program for a first-in-class long-acting PTH tablets for patients with hypoparathyroidism. And this program combines OPKO's proprietary long-acting PTH variants with Entera's N-Tab technology.
研究結果將用於指導我們與Entera Bio合作開發的口服氧胰高血糖素後續研發。我們近期也擴大與Entera的合作關係,新增第三個共同計畫:為甲狀旁腺功能低下症患者開發同類首創(first-in-class)的長效PTH錠劑。該計畫結合OPKO專有的長效PTH變體與Entera的N-Tab技術。
And we and Entera each hold a 50% ownership interest in this program, and we will share development costs equally. Presuming favorable PK/PD data, we're targeting an IND filing later this year. Now our international Pharmaceutical operations continued to experience solid growth during Q1 with healthy contributions to the overall business. For the quarter, global Pharmaceutical product sales grew about 9% versus the prior year due to favorable demand trends as well as foreign currency tailwinds.
我們與Entera各自持有該計畫50%的所有權權益,並將平均分攤開發成本。在PK/PD數據良好的前提下,我們目標於今年稍晚提交IND申請。接著,我們的國際製藥營運在第一季持續呈現穩健成長,並對整體業務作出良好貢獻。本季全球製藥產品銷售額較去年同期成長約9%,主要受惠於有利的需求趨勢以及外匯順風。
Our partner, Pfizer, continues its global commercial expansion of our long-acting growth hormone product, NGENLA. Now as a final topic for today, I'd like to turn attention to our Diagnostics business. Following the sale of BioReference's oncology assets to Labcorp in 2025, BioReference is now a regionally focused clinical laboratory with a national specialty testing franchise, highlighting our proprietary 4Kscore test. We operate with a more efficient footprint with an expanding menu of higher-margin services.
我們的合作夥伴輝瑞(Pfizer)持續在全球推進我們長效生長激素產品NGENLA的商業化擴張。作為今天最後一個主題,我想把焦點轉向我們的診斷業務。在2025年將BioReference的腫瘤資產出售給Labcorp之後,BioReference目前是一家以區域為重點的臨床實驗室,同時擁有全國性的專科檢測業務,並凸顯我們的專有4Kscore檢測。我們以更精實的營運版圖運作,並持續擴充更高毛利服務的項目組合。
In the first quarter of 2026, BioReference's streamlined business showed a volume increase of more than 3% in the number of accessions per day compared to the previous quarter. This performance was reflected in particularly strong volume in our [SQHC] and corrections business lines plus momentum in our higher-margin services.
在2026年第一季,BioReference 精簡後的業務相較前一季,每日檢體收件數(accessions)增加超過3%。此表現反映在我們 [SQHC] 與更正(corrections)業務線的特別強勁量能,以及我們較高毛利服務的動能。
Margins also saw improvement versus Q4, primarily driven by the aforementioned volume increase and continued efficiency gains, including an additional 4% reduction in headcount. Within Diagnostics, 4Kscore continues to be an important part of our test offering and the recent label update, which removes the digital rectal examination requirement positions us to broaden adoption beyond urologists and gradually build a presence in primary care.
毛利率相較第四季亦有所改善,主要受前述量能增加與持續的效率提升所帶動,其中包括人力再減少4%。在診斷業務中,4Kscore 仍是我們檢測產品組合的重要一環;近期的標籤更新移除了肛門指診(digital rectal examination)的要求,使我們得以將採用範圍擴大至泌尿科醫師以外,並逐步在基層醫療建立能見度。
And we see 4Kscore as a unique high-value asset with the potential to deliver significant revenue and profitability as we broaden payer coverage and continue educating both urologists and primary care physicians about its clinical utility. With our geographically focused footprint, rightsized workforce, expanding menu and proprietary 4Kscore test, we are seeing a nice performance improvements at BioReference, and we believe that these continued efforts achieve breakeven in the business -- will help achieve breakeven in the business by the middle of the year.
我們也將 4Kscore 視為獨特的高價值資產;隨著我們擴大付款方(payer)涵蓋並持續向泌尿科與基層照護醫師宣導其臨床效用,它有潛力帶來可觀的營收與獲利。憑藉我們地理聚焦的營運版圖、精實的人力配置、擴充的檢測項目,以及專有的 4Kscore 檢測,我們看到 BioReference 的表現有明顯改善,並相信這些持續的努力——將有助於在年中前使該業務達到損益兩平。
In summary, our progress with the ModeX pipeline, along with our partnerships and collaborations, international Pharmaceutical portfolio and restructured Diagnostics business have really transformed OPKO into a more targeted innovation-led organization with multiple key catalysts coming up later this year.
總結而言,我們在 ModeX 研發管線的進展,加上合作夥伴關係與協作、國際藥品組合,以及重整後的診斷業務,確實已將 OPKO 轉型為更聚焦、以創新驅動的組織,且今年稍晚將有多項關鍵催化劑到來。
So with that, I'll turn the call over to Adam to review our financial results and outlook. Adam?
接下來,我把電話交給 Adam,請他回顧我們的財務結果與展望。Adam?
Adam Logal - Chief Financial Officer, Senior Vice President, Chief Accounting Officer, Treasurer
Adam Logal - Chief Financial Officer, Senior Vice President, Chief Accounting Officer, Treasurer
Thank you, Elias. We ended the quarter with a strong cash position with over $341 million in cash, cash equivalents and restricted cash, which is more than sufficient to fund our ongoing operating needs and development plans, while we also are returning capital to our shareholders.
謝謝你,Elias。本季結束時,我們的現金部位強勁,現金、約當現金及受限制現金合計超過3.41億美元,足以支應我們持續的營運需求與開發計畫,同時我們也在向股東返還資本。
Let's start with the financial performance of our Diagnostics business. The financial results for the first quarter met our expectations, and we are encouraged by the progress the team has made, sequentially improving the operating loss by $5.3 million and by $11 million over the Q1 of last year. We have restructured this business and remain on track to achieve breakeven as measured by results from operations before noncash expenses by the middle of the year.
先從診斷業務的財務表現談起。2026年第一季的財務結果符合我們預期,我們也對團隊的進展感到鼓舞:營業損失較前一季改善530萬美元,較去年第一季改善1,100萬美元。我們已重整該業務,並仍按計畫在年中前達到損益兩平;此處以扣除非現金費用前的營運結果衡量。
Revenue for Q1 2026 was $72.2 million, including $6.5 million from our 4Kscore test. Revenue in Q1 2025 was $102.8 million, with the year-over-year decline expected due to the oncology customer accounts included in the Labcorp transaction that closed in September of 2025. Revenue from our retained business slightly declined versus the prior year, principally due to test mix changes as we shifted some unprofitable but higher-priced esoteric testing to our strategic partners, along with snowstorms that impacted the New York, New Jersey market, which we mentioned in our February call.
2026年第一季營收為7,220萬美元,其中包含 4Kscore 檢測的650萬美元。2025年第一季營收為1.028億美元;年對年下滑符合預期,原因在於2025年9月完成的 Labcorp 交易中包含的腫瘤客戶帳戶。我們保留業務的營收較去年同期小幅下滑,主要因檢測組合變化:我們將部分不具獲利性但單價較高的特殊檢測(esoteric testing)轉交給策略夥伴;此外,暴風雪影響了紐約與新澤西市場,我們在2月的電話會議中曾提及。
Total costs and expenses were $85.1 million, down from $126.8 million last year, reflecting the September 2025 transaction closing as well as the continued efforts to rationalize our cost structure to align with our focused geographic footprint and testing offerings. Our Diagnostic operating loss was $13 million compared to $23.9 million in Q1 2025. Depreciation and amortization for this segment came in at $3.9 million, down from $5.7 million in 2025.
總成本與費用為8,510萬美元,低於去年的1.268億美元,反映2025年9月交易完成,以及我們持續致力於合理化成本結構,使其與我們聚焦的地理版圖與檢測項目相匹配。診斷業務營業損失為1,300萬美元,較2025年第一季的2,390萬美元改善。該分部折舊與攤銷為390萬美元,低於2025年的570萬美元。
Turning to our Pharmaceutical business. Revenue was $52 million in Q1 compared to $47.1 million in the prior year. Revenue from product sales increased to $38 million, up from $34.8 million, reflecting higher sales volume in our international operations and foreign exchange tailwinds during the quarter. As we continue to focus on the profitability of Rayaldee, the gross to net improvements we began to realize last year have resulted in meaningful positive cash flow from operations in 2026, while maintaining overall revenue levels.
接著看我們的製藥業務。第一季營收為5,200萬美元,較去年同期的4,710萬美元增加。產品銷售營收增至3,800萬美元,高於3,480萬美元,反映我們國際營運的銷售量提升,以及本季匯率帶來的順風。隨著我們持續聚焦 Rayaldee 的獲利能力,自去年開始實現的毛額到淨額(gross to net)改善,使我們在維持整體營收水準的同時,於2026年帶來具意義的正向營運現金流。
Rayaldee contributed $6.3 million during Q1 of both 2026 and 2025, reflecting slightly improved gross to net, offset by a slight decline in volume. Our Pfizer profit share was $6.4 million for the quarter, reflecting a 42% increase to 2025's $4.5 million. Pfizer's progress on the global commercialization of NGENLA continues to show consistent growth. The 2025 profit share was negatively impacted by certain gross to net and inventory revaluations that did not recur in 2026.
Rayaldee 在2026年與2025年第一季皆貢獻630萬美元,反映毛額到淨額略有改善,但被銷量小幅下滑所抵銷。本季我們來自輝瑞(Pfizer)的利潤分成為640萬美元,較2025年的450萬美元增加42%。輝瑞在 NGENLA 全球商業化方面的進展持續呈現穩健成長。2025年的利潤分成受到某些毛額到淨額與存貨重估的負面影響,而這些因素在2026年未再發生。
In addition, BARDA funding was $4 million in the first quarter of 2026 compared to $7 million a year ago, reflecting the start of our COVID clinical program under this collaboration, while the 2025 period included higher levels of CMC activities for our infectious disease programs. As a result, IP transfer and other revenue was $14 million compared to 2025's $12.3 million.
此外,2026年第一季 BARDA 資金為400萬美元,低於一年前的700萬美元,反映我們在此合作下啟動 COVID 臨床計畫;而2025年期間則包含我們傳染病計畫較高水準的 CMC 活動。因此,IP 移轉及其他營收為1,400萬美元,較2025年的1,230萬美元增加。
Costs and expenses for our Pharmaceutical business were $81.7 million, similar to 2025's $81.9 million, reflecting a favorable sales mix of higher-margin products while we continue to meaningfully invest in our R&D programs. R&D for Q1 2026 totaled $28.8 million, down slightly from $30.2 million in the 2025 quarter due to lower CMC-related activities, partially offset by increased levels of our early-stage clinical trials.
製藥業務成本與費用為8,170萬美元,與2025年的8,190萬美元相近,反映較高毛利產品的有利銷售組合,同時我們仍持續大幅投資研發計畫。2026年第一季研發費用合計2,880萬美元,較2025年同期的3,020萬美元略降,原因為 CMC 相關活動減少,部分被早期臨床試驗投入增加所抵銷。
As a result, our Pharmaceutical operating loss was $30 million in Q1 2026 compared to last year's operating loss of $34.8 million. Depreciation and amortization expense was $18.3 million, which was slightly higher than $17.8 million from last year.
因此,2026年第一季製藥業務營業損失為3,000萬美元,較去年的3,480萬美元改善。折舊與攤銷費用為1,830萬美元,略高於去年的1,780萬美元。
For our consolidated financial results, total revenues for Q1 2026 were $124.2 million compared to $149.9 million in the first quarter of 2025. Consolidated operating loss for Q1 2026 was $51 million improved from 2025's $67.2 million loss. Our net loss for Q1 2026 was $54.8 million or $0.07 per share, which improved from 2025's net loss of $67.6 million or $0.10 per share.
就合併財務結果而言,2026年第一季總營收為1.242億美元,較2025年第一季的1.499億美元下降。2026年第一季合併營業損失為5,100萬美元,較2025年的6,720萬美元損失改善。2026年第一季淨損為5,480萬美元或每股0.07美元,較2025年的淨損6,760萬美元或每股0.10美元改善。
Looking forward to the outlook for our second quarter of 2026, we expect total revenue to be between $127 million to $132 million, with revenue of services from $72 million to $76 million, with the range reflecting several assumptions around testing volumes and reimbursement pricing. We expect Pharmaceutical product revenue of $38 million to $42 million, and we expect IP and other revenue to be between $15 million to $19 million, including the Pfizer profit share of $6 million to $8 million.
展望2026年第二季,我們預期總營收介於1.27億至1.32億美元,其中服務營收介於7,200萬至7,600萬美元;此區間反映對檢測量與給付價格(reimbursement pricing)的若干假設。我們預期製藥產品營收為3,800萬至4,200萬美元,並預期 IP 與其他營收介於1,500萬至1,900萬美元,其中包含輝瑞利潤分成600萬至800萬美元。
Total costs and expenses for Q2 are expected to come in between $180 million and $190 million, excluding the earn-out anticipated from Labcorp related to the closing of our second transaction as well as any onetime -- onetime restructuring costs. With our expanding investments in R&D, we expect R&D to become between $32 million and $38 million, partially offset by $5 million to $7 million in BARDA funding. And we expect depreciation and amortization expense of approximately $24 million.
第二季總成本與費用預計介於1.80億至1.90億美元,不包含因完成我們與 Labcorp 第二筆交易而預期取得的或有對價(earn-out),以及任何一次性——一次性重整成本。隨著我們擴大研發投資,我們預期研發費用介於3,200萬至3,800萬美元,部分由500萬至700萬美元的 BARDA 資金抵銷。我們預期折舊與攤銷費用約為2,400萬美元。
We're affirming our full year guidance that we introduced when we reported our Q4 results, which are included in our earnings release. And as of the end of Q1, we had approximately $108 million authorized to repurchase shares of our common stock.
我們重申在公布第四季結果時所提出的全年指引,相關內容已包含於我們的財報新聞稿中。截至第一季末,我們仍有約1.08億美元的授權額度可用於回購本公司普通股。
With that, we have concluded our prepared remarks, and we'll open the call for questions.
至此,我們已完成事先準備的發言,接下來將開放提問。
Operator
Operator
(Operator Instructions)
(接線員指示)
Maury Raycroft, Jefferies.
Maury Raycroft,Jefferies。
Maury Raycroft - Equity Analyst
Maury Raycroft - Equity Analyst
Can you hear me now?
你們現在聽得到我嗎?
Adam Logal - Chief Financial Officer, Senior Vice President, Chief Accounting Officer, Treasurer
Adam Logal - Chief Financial Officer, Senior Vice President, Chief Accounting Officer, Treasurer
Yeah, well, go ahead.
可以,你繼續。
Maury Raycroft - Equity Analyst
Maury Raycroft - Equity Analyst
I'm sorry about that. Starting off, I was going to ask one on 4Kscore. And wondering if you can comment on the proportion of payer policies that have been updated to reflect your new FDA label? And what else needs to be done on this front? And can you talk about what you're doing to get more primary care docs on board with the Diagnostic?
不好意思。先從 4Kscore 的問題開始。想請你們評論一下:目前有多少比例的付款方(payer)保單/給付政策已更新,以反映你們新的 FDA 標籤?在這方面還需要做哪些工作?另外也請談談你們為了讓更多基層醫療(primary care)醫師採用這項診斷檢測,正在做哪些事情?
And are there education efforts underway there?
那邊是否也有在進行教育推廣?
Adam Logal - Chief Financial Officer, Senior Vice President, Chief Accounting Officer, Treasurer
Adam Logal - Chief Financial Officer, Senior Vice President, Chief Accounting Officer, Treasurer
Yeah. So I'll start off, Maurice. So on the payer policies, we are continuing to work across the board, starting with Medicare to update their coverage determination to more accurately reflect the FDA label. But beyond that, we are engaging with payers. I'll say there's not many payers that had a requirement for DRE on the commercial setting or outside of Medicare.
是的。Maurice,我先回答。就付款方政策而言,我們持續全面推進,先從 Medicare 著手,更新其給付判定(coverage determination),使其更精準反映 FDA 標籤。除此之外,我們也在與各付款方接洽。我想說的是,在商業保險環境或 Medicare 以外,要求進行 DRE 的付款方其實不多。
So we are continuing to look at that from an overall perspective. So as it relates to going into the primary care market, we are waiting for that LCD to get updated before we more aggressively go into the primary care market. And we would expect that to happen in the middle of this year.
因此我們會從整體角度持續檢視這件事。至於切入基層醫療市場,我們會等 LCD 更新後,再更積極推進基層醫療市場。我們預期這會在今年年中發生。
Maury Raycroft - Equity Analyst
Maury Raycroft - Equity Analyst
Got it. Okay. And anything more you can say on how we should think about growth expectations for the base business and what 4Kscore -- how 4Kscore will contribute to that growth over the course of the year?
了解。好。那關於基礎業務(base business)的成長預期,以及 4Kscore 在今年整體成長中會如何貢獻,還有沒有更多可以分享的?
Adam Logal - Chief Financial Officer, Senior Vice President, Chief Accounting Officer, Treasurer
Adam Logal - Chief Financial Officer, Senior Vice President, Chief Accounting Officer, Treasurer
Yeah, so I think you'll see in the implied way that the math works between the first half and second half, you'll see some growth coming in the back half of the year, driven by some of the expectations we have around 4K and just generally a more focused footprint on BioReference's New York, New Jersey businesses. So 4K grew significantly last year. The comps this year were a little bit more challenging.
是的,我想你會從上半年與下半年的隱含數學關係中看到:今年下半年會有一些成長,主要由我們對 4K 的一些預期所帶動,並且整體上更聚焦於 BioReference 在紐約與新澤西的業務版圖。4K 去年成長顯著。今年的比較基期(comps)則稍微更具挑戰。
So we didn't see the same level of growth that we saw last year, but we would have an expectation that we should achieve double-digit growth on 4K volumes this year, which will lead to us getting into that range of $300 million to $312 million for the total business of BioReference.
因此我們沒有看到與去年同等幅度的成長,但我們預期今年 4K 檢測量(volumes)仍可達到雙位數成長,進而帶動 BioReference 整體業務達到 3.00 億至 3.12 億美元的區間。
Maury Raycroft - Equity Analyst
Maury Raycroft - Equity Analyst
Got it. Okay. That's helpful. And maybe one other question on NGENLA, GENOTROPIN profit share. Wondering if you can comment more on just your latest communications with Pfizer related to forecast there?
了解。好。這很有幫助。另外想再問一題關於 NGENLA、GENOTROPIN 的利潤分成(profit share)。想請你們多談談近期與 Pfizer 就該部分預測(forecast)的最新溝通情況?
And can you clarify whether you're observing commercial impact from the Dear Doctor letter that Pfizer sent to prescribers over the course of summer last year and that Pfizer is doing more on that front to increase switching from GENOTROPIN to NGENLA?
另外也請釐清:你們是否觀察到 Pfizer 去年夏天寄給處方醫師的「Dear Doctor」信函所帶來的商業影響?以及 Pfizer 是否在這方面做了更多動作,以提高從 GENOTROPIN 轉換到 NGENLA 的比例?
Adam Logal - Chief Financial Officer, Senior Vice President, Chief Accounting Officer, Treasurer
Adam Logal - Chief Financial Officer, Senior Vice President, Chief Accounting Officer, Treasurer
Yeah, so we have continued to see pretty good growth for NGENLA is part of the total franchise between GENOTROPIN and NGENLA. So we think Pfizer has been quite aggressive in seeing that conversion pull through and continuing to maintain their share or grow their share beyond some of the other long-actings in the growth hormone space, both here in the US but also globally.
是的,所以我們持續看到 NGENLA 在 GENOTROPIN 與 NGENLA 的整體產品線(franchise)中維持相當不錯的成長。因此我們認為 Pfizer 在推動轉換落地(conversion pull-through)方面相當積極,並持續維持其市占,或在生長激素長效製劑領域相較其他產品進一步擴大市占,不論是在美國或全球。
We've been -- we've seen pretty significant growth quarter-over-quarter and year-over-year for the NGENLA share. We still think that Pfizer owns around one-third of the global long-acting market. The conversions are happening at a consistent pace, not as aggressively as we previously had expected, but certainly ramping upwards. And as it relates to Pfizer sharing their outlooks or forecast, they don't necessarily give us anything forward-looking as it relates to how we should expect the entire franchise to grow. I think I covered all the questions, Maury.
我們看到 NGENLA 的市占在季對季與年對年都有相當顯著的成長。我們仍認為 Pfizer 約掌握全球長效市場的三分之一。轉換正以穩定速度進行,沒有先前我們預期的那麼激進,但確實正在加速上升。至於 Pfizer 分享其展望或預測,他們不一定會提供任何前瞻性資訊,讓我們去推估整個產品線應該如何成長。Maury,我想我已回答完所有問題。
Maury Raycroft - Equity Analyst
Maury Raycroft - Equity Analyst
Yeah, that was helpful. Thanks for taking my questions.
是的,很有幫助。謝謝回答我的問題。
Operator
Operator
Brian Cheng, JPMorgan.
Brian Cheng,JPMorgan。
Brian Chang - Analyst
Brian Chang - Analyst
Hey guys, thanks for taking my question this afternoon. Maybe just first, I want to know a little bit more about your expectations for your tetravalent TCE T-cell lymphoma trial. Can you walk through what you'll be looking for from that study? What will be good response data to see early on? And do you have a sense of what will be a good line of setting for this specific mechanism? And I have a follow-up. Thank you.
各位好,謝謝今天下午回答我的問題。首先我想更了解你們對四價(tetravalent)TCE T 細胞淋巴瘤試驗的預期。能否說明一下你們會從該研究中重點觀察哪些指標?早期看到怎樣的反應(response)數據會算是不錯?以及你們是否對這個特定作用機制在治療線別(line of setting)上,哪一線會是較好的定位有概念?我還有一個追問。謝謝。
Elias Zerhouni - President, Vice Chairman of the Board
Elias Zerhouni - President, Vice Chairman of the Board
I think Gary, who's leading the ModeX can answer that. That's a great question actually. That's good to talk about. Gary?
我想由負責 ModeX 的 Gary 來回答。這其實是個很好的問題。很值得談談。Gary?
Gary Nabel - Chief Innovation Officer, Director
Gary Nabel - Chief Innovation Officer, Director
Yeah, Thanks, Elias. Well, obviously, the first order of business is to show acceptable toxicity, and that's where the early Phase I data becomes important. We don't expect to see anything different from other candidates that have gone forward, but we need to get through that first. Once we go into the therapeutic efficacy, what we're particularly interested in is looking at the failures to the CD20 multispecifics or bispecifics and for example, molecules like glofitamab for which resistance becomes evident quite frequently.
好的,謝謝你,Elias。很明顯,首要任務是證明毒性(toxicity)可接受,而這也是早期第一期(Phase I)數據之所以重要的原因。我們不預期會看到與其他已推進的候選藥物有什麼不同,但我們需要先通過這一關。一旦進入治療有效性(therapeutic efficacy),我們特別感興趣的是觀察對 CD20 多特異性或雙特異性(multispecifics or bispecifics)治療失敗的患者,例如對 glofitamab 這類分子,抗藥性相當常見。
And so we think as a starting indication, this will be a population where we can essentially salvage a therapeutic response. I should also -- and then eventually, that gives us the opportunity to move up in terms of the actual order of -- and priority of treatment.
因此我們認為,作為起始適應症,這會是一個我們基本上能夠挽救(salvage)治療反應的族群。我也要補充——而最終,這也讓我們有機會在實際治療順序與優先順序上往前推進。
The other indication that we shouldn't forget is that by depleting B cells with CD19 and CD20, this molecule has an opportunity to be used in autoimmunity. There are opportunities, for example, in lupus and other autoimmune B-cell diseases where we will look for its ability to reduce the inflammatory reaction. And those will come after we get the initial safety data, but not much delayed after that.
另一個不應忽略的適應症是:透過 CD19 與 CD20 耗竭 B 細胞,這個分子也有機會用於自體免疫(autoimmunity)。例如在紅斑性狼瘡(lupus)及其他 B 細胞相關自體免疫疾病上,都存在機會,我們會觀察其降低發炎反應的能力。這些會在我們取得初步安全性數據之後展開,但不會延遲太久。
So there are multiple indications that we think we can pursue.
因此我們認為可以追求多個適應症。
Brian Chang - Analyst
Brian Chang - Analyst
Got it. That's very helpful. And then maybe just one more on the Merck partnership on the EBV vaccine. Any update in terms of data disclosure perhaps later this year? And also can you give us a better sense about the next step for that program? Thank you.
了解。非常有幫助。接著再問一題關於與 Merck 在 EBV 疫苗上的合作。今年稍晚是否有任何數據揭露(data disclosure)的更新?另外也請你們更清楚說明該計畫的下一步是什麼?謝謝。
Elias Zerhouni - President, Vice Chairman of the Board
Elias Zerhouni - President, Vice Chairman of the Board
Gary?
Gary?
Gary Nabel - Chief Innovation Officer, Director
Gary Nabel - Chief Innovation Officer, Director
Sure. Yes, Elias, do you want me to cover that as well.
當然。是的,Elias,你希望我也一併說明這部分嗎?
Elias Zerhouni - President, Vice Chairman of the Board
Elias Zerhouni - President, Vice Chairman of the Board
Yes, please.
是的,麻煩。
Gary Nabel - Chief Innovation Officer, Director
Gary Nabel - Chief Innovation Officer, Director
Yes, the -- yes. So as you know, we began the Phase I study a while ago with 2 different adjuvants i.e. that where we compared their efficacy one to another, both in naive individuals, but -- and also in virally infected or formerly virally infected individuals. The reason we're looking at both populations is that ultimately, the vaccine is intended for patients who are EBV-naive. But another consideration we have to watch out for is that the vaccine doesn't have any untoward effects on the people who are EBV positive.
好的——是的。如你所知,我們在一段時間前已啟動第一期研究,使用兩種不同的佐劑(adjuvants),也就是比較兩者彼此的效力;研究對象包含未感染者(naive individuals),同時也包含病毒感染者或曾感染者。我們之所以同時觀察兩種族群,是因為最終該疫苗的目標對象是 EBV 未感染者(EBV-naive)。但我們也必須留意另一個考量:疫苗不應對 EBV 陽性者造成任何不良影響(untoward effects)。
The vaccine trial has gone smoothly. Enrollment has been very facile and no surprises. We are not disappointed at all in terms of the immunogenicity that we're seeing. But what we are trying to do in anticipation of Phase II is to get a better read on the EBV negative patients who are a much smaller proportion of the overall population. So we have been filling in those blanks with the idea that we will then down select one of the two adjuvants and simplify the formulations for Phase II.
疫苗試驗進展順利。受試者招募非常順暢,沒有任何意外。就我們所看到的免疫原性而言,我們完全不失望。但我們在為第二期(Phase II)做準備時,正嘗試更清楚地了解 EBV 陰性患者;這類患者在整體族群中占比小得多。因此,我們一直在補足這些缺口,並計畫之後在兩種佐劑中下選其一,並為第二期簡化配方。
So I do think that information will be available certainly by the end of the year. And we won't disclose any trial results, obviously, until all the data are in. But I think you will hear about the evolving plans for Phase II and then what the rationale and what the data is behind that. And I just don't want to get too far in front of it because these are really decisions that Merck will make. And so we don't want to do anything that steps outside of the guidelines they normally use for advancing their products.
所以我確實認為,這些資訊肯定會在年底前可取得。而且很明顯地,在所有數據都到齊之前,我們不會披露任何試驗結果。但我想你們會聽到第二期計畫如何逐步成形,以及其背後的理由與支撐該決策的數據。我只是不想說得太超前,因為這些確實是默克(Merck)將做出的決策。因此,我們不希望做任何超出他們通常用於推進其產品之指引範圍的事情。
Brian Chang - Analyst
Brian Chang - Analyst
Thanks for the color and looking forward to it.
謝謝補充說明,期待後續進展。
Operator
Operator
Yi Chen, H.C. Wainwright.
Yi Chen,H.C. Wainwright。
Yi Chen - Analyst
Yi Chen - Analyst
Thank you for taking my questions. My first question is the reported first quarter revenue is just a little bit below your previous guidance. So can you talk about which segment in revenue sort of underperformed a little bit in the first quarter? And how should we look at the second quarter revenue guidance?
謝謝讓我提問。我的第一個問題是,第一季公布的營收略低於你們先前的指引。能否談談第一季是哪一個營收分項的表現稍微不如預期?以及我們應該如何看待第二季的營收指引?
Adam Logal - Chief Financial Officer, Senior Vice President, Chief Accounting Officer, Treasurer
Adam Logal - Chief Financial Officer, Senior Vice President, Chief Accounting Officer, Treasurer
Yeah, Where the majority of that shortfall came was actually related to our other revenue and IP revenue. So we had planned activities to do some additional CMC activities under our BARDA contract, and those got delayed until later this year. So that was about almost $6 million of the shortfall, which is what took us below where we had previously guided. So from a net bottom line perspective, no impact because R&D came in lower than we had forecasted, along with the associated revenue that would have been recorded.
是的,這個缺口主要其實來自於我們的其他收入與 IP(智慧財產)收入。我們原本規劃在 BARDA 合約下進行一些額外的 CMC 活動,但這些活動延後到今年稍晚。因此,缺口大約接近 600 萬美元,這也是我們低於先前指引的原因。所以從淨損益的角度來看沒有影響,因為研發費用也低於我們的預測,同時原本會認列的相關收入也就沒有入帳。
Hopefully, that makes sense.
希望這樣說得清楚。
Yi Chen - Analyst
Yi Chen - Analyst
Got it. Got it. And also with respect to the commercial plan for MDX2301 for prevention of COVID-19, do you have any plan to commercialize it just by yourself in the future? Or is it going to be a contract with the government?
了解。了解。另外,關於 MDX2301 用於 COVID-19 預防的商業化計畫,未來你們有計畫自行商業化嗎?還是會以政府合約的方式進行?
Elias Zerhouni - President, Vice Chairman of the Board
Elias Zerhouni - President, Vice Chairman of the Board
Well, I'll start and let Gary also comment. I mean from our point of view, I mean depending upon the results we observed, I mean, we have two markets that really need such a molecule given its ability to resist mutations or so far has been an antibody that has shown activity against all known variants. So we think that the immune-impaired population would be cancer patients or patients under therapies that are immunosuppressive or cannot really get vaccinated or mount an immune response. Those would be the primary population that would really benefit from such a molecule.
我先回答,之後也讓 Gary 補充。就我們的觀點而言,取決於我們觀察到的結果;考量到它抵抗突變的能力——或者說,到目前為止它是一種對所有已知變異株都顯示活性的抗體——我們認為確實有兩個市場非常需要這樣的分子。因此我們認為免疫功能受損族群,包括癌症患者,或正在接受免疫抑制治療、或無法真正接種疫苗或產生免疫反應的患者。這些將是最主要、也最能從這種分子受益的族群。
And that's about 30 million people in the US. In terms of developing it, we definitely are looking for a partner to co-develop or find a way because I think it's going to require that sort of expertise and experience in the marketplace around the immune-impaired populations, whether it be cancer centers or other nursing homes and all that. So yes, the question is what population immune-impaired. Doing it on our own? No, probably with a partner that can have -- add to our clinical development process.
在美國大約有 3,000 萬人屬於這類族群。就開發而言,我們確實在尋找合作夥伴共同開發或找到合作方式,因為我認為這需要在免疫功能受損族群市場方面的專業與經驗,不論是癌症中心或其他護理之家等通路。所以是的,問題在於鎖定哪個免疫功能受損族群。要我們自己做嗎?不,我們可能會與能夠——在臨床開發流程上補強我們的——合作夥伴一起做。
Gary, am I missing anything?
Gary,我有漏掉什麼嗎?
Gary Nabel - Chief Innovation Officer, Director
Gary Nabel - Chief Innovation Officer, Director
Well, yes, thanks, Elias. The only thing I would add is that just to be clear, there can be two different partners or two different sources of revenue. So clearly, as this gets to the point of being approved, this is a product that BARDA would want to stockpile. And so yes, there would be some -- assuming we get to that point, some kind of a contract with the government to provide material to the stockpile. I think both BARDA and we feel that the best way of addressing future threats from COVID is to also make sure it's out there and available for those who need it.
好的,謝謝你,Elias。我唯一想補充的是,為了釐清,可能會有兩個不同的合作夥伴或兩種不同的收入來源。很明顯地,當產品推進到獲准的階段,這會是 BARDA 想要納入戰備儲備(stockpile)的產品。因此是的——假設我們能走到那一步——將會有某種形式的政府合約,提供物料給儲備庫。我認為 BARDA 和我們都覺得,因應未來 COVID 威脅的最佳方式,也包括確保它能在市場上取得並提供給真正需要的人。
And so that's why Elias is saying we think there's a great unmet need in people who don't respond to vaccines, people who have underlying cancers or elderly who can't mount effective immune responses. And so yes, we, one way or another, want to address that market. And I think that at this point, it's probably just too early to say what commercial partner or what commercial infrastructure we might choose to pursue. I think our eye is mostly on the next steps of getting the approvals for in-licensure from FDA. That's kind of a near-term target.
因此這也是 Elias 所說的:我們認為在對疫苗沒有反應的人、罹患基礎癌症的人,或無法產生有效免疫反應的高齡者身上,存在很大的未被滿足需求。所以是的,我們會以某種方式去滿足那個市場。而我認為在此時此刻,談我們可能選擇追求哪一家商業合作夥伴或哪種商業化基礎設施,仍然太早。我想我們目前的重點主要放在下一步:取得 FDA 的授權核准(in-licensure approvals)。那是近期目標。
Operator
Operator
Kevin DeGeeter, Ladenburg Thalmann.
Kevin DeGeeter,Ladenburg Thalmann。
Kevin DeGeeter - Analyst
Kevin DeGeeter - Analyst
Hey, good afternoon. Thanks, everybody, for taking our questions. My question is first on the in vivo CAR-T program. We've seen a lot -- continue to see a lot of activity on the M&A front in the space. Can you just remind us maybe of two things. One, how you see the differentiation of your in vivo CAR-T platform from some of the others that are slightly more advanced in early-stage clinical development? And then just two, how you see key milestones that you need to execute against to bring that program into the clinic late in '26 or early '27?
嗨,午安。謝謝各位回答我們的問題。我的問題首先是關於體內(in vivo)CAR-T 計畫。我們看到該領域的併購(M&A)動態很多——而且仍持續活躍。能否請你們提醒我們兩點。第一,你們如何看待自家 in vivo CAR-T 平台相較於其他在早期臨床開發上稍微更超前的平台之差異化?第二,你們認為需要達成哪些關鍵里程碑,才能在 2026 年底或 2027 年初把該計畫推進到臨床?
Elias Zerhouni - President, Vice Chairman of the Board
Elias Zerhouni - President, Vice Chairman of the Board
I'll start and Gary, if -- let me start and then you can cover what I'm missing. So actually, the in vivo CAR-T program is not a new program. This is something we have been doing for several years, thinking about it from the point of view of differentiation. What differentiation do we talk about?
我先開始,Gary,如果——我先說,然後你再補充我漏掉的部分。其實,這個 in vivo CAR-T 計畫並不是新計畫。這是我們做了好幾年的事情,從差異化的角度來思考。我們談的差異化是什麼?
Number one, as you know, in the lipid nanoparticles by themselves do not target specific cells. And so we thought that the number 1 differentiation would be targeting of the lipid nanoparticle better than the competition does. And in this case, we knew that we could use our multi-specific platform to target different types of cells and in different ways by conjugating an antibody on top of the LNP, but conjugating in a covalent way. So it's attached. It doesn't fall away.
第一,如你所知,脂質奈米粒子(LNP)本身並不會靶向特定細胞。因此我們認為第一個差異化點,是讓 LNP 的靶向能力優於競爭對手。在這裡,我們知道可以利用我們的多特異性平台,透過在 LNP 表面接合抗體,以不同方式靶向不同類型的細胞;而且是以共價方式接合。所以它是固定連接的。不會脫落。
And then when that's done, it goes to the proper target cells in a proportion that is favorable to the activity of the CAR-T technology. So that leads to, a, a differentiation; b, the ability to multiply the number of targets you can -- and number of cells you can -- number of type of cells you can address, but also it reduces the need for higher doses because you don't have a loss of LNPs in areas where there is no targeting. So that's number one. So differentiation one is unique technology combination of LNPs that we actually improved ourselves in a proprietary way with lipids that are really designed for what we do, plus chemical conjugation that is unique in the business.
而當這樣完成後,它會以有利於 CAR-T 技術活性的比例,送達正確的靶細胞。因此帶來:a,差異化;b,能夠擴增你可靶向的標的數量——以及你能——你能處理的細胞數量——你能處理的細胞類型數量;同時也降低對更高劑量的需求,因為不會在沒有靶向的區域造成 LNP 的流失。這是第一點。所以第一個差異化是:我們把 LNP 與一項獨特的化學接合技術結合;LNP 本身也由我們以專有方式改良,使用的脂質是為我們的用途而設計,且這種化學共價接合在業界是獨一無二的。
And so having the multispecifics for the LNP gave us potential. Second is we use what we know best, which is a targeting and activation, which also leads us to actually have effects at 5 to 10 times lower doses than the competition, which obviously improves the therapeutic window. And so that's the second one. The third one is the fact that we found ways of having cargoes that are both RNA and DNA. And that is very promising because others haven't been able to achieve that.
因此,LNP 具備多特異性讓我們擁有了潛力。第二點是,我們運用我們最擅長的,也就是靶向與活化,這也使得我們實際上能以比競品低 5 到 10 倍的劑量達到效果,這顯然改善了治療窗。所以這是第二點。第三點是,我們找到方法讓載荷同時可以是 RNA 與 DNA。這非常有前景,因為其他人尚未能做到這一點。
And last but not least, because we have a multispecific technology, we can create chimeric antigens that are also bispecific or trispecific themselves. So that gives you a sense. Now the other question, key milestones. We've already completed all the nonhuman primate studies. We're in the middle of creating the CMC essentially, which will be finished in terms of drug product within the next few months, three, four months, five months, maybe.
最後但同樣重要的是,因為我們有多特異性技術,我們可以製作嵌合抗原,而這些抗原本身也可以是雙特異或三特異。所以這讓你有個概念。那麼另一個問題,關鍵里程碑。我們已經完成所有非人靈長類研究。我們正在進行 CMC 的建立,基本上在未來幾個月內,藥品製劑(drug product)方面會完成,可能三、四個月、五個月左右。
And then preparing, in fact, the launch of the first trial, human trial before the end of this year, we hope. Those are the milestones for us to get into the clinic and show both safety and efficacy, what we believe is going to be a more effective way of truly deploying this very promising technology. I stop here. Gary, did I miss anything that you want to add color to?
接著其實是在準備在今年年底前啟動第一個試驗、人體試驗,我們希望如此。這些就是我們進入臨床並同時展示安全性與有效性的里程碑;我們相信這將是一種更有效的方式,真正部署這項非常有前景的技術。我先說到這裡。Gary,我有漏掉你想補充說明的任何內容嗎?
Gary Nabel - Chief Innovation Officer, Director
Gary Nabel - Chief Innovation Officer, Director
Yes, I think you covered it very well, Elias. The only minor things I would add are that we -- while our lead program is targeted towards in vivo CAR-T cells, we've also learned how to use other antibodies to target genes into other cell types so that we can target B cells, we can target NK cells.
是的,我認為你講得非常完整了,Elias。我唯一想補充的一點小事是——雖然我們的領先專案是針對體內(in vivo)CAR-T 細胞,但我們也學會如何使用其他抗體把基因導入其他細胞類型,因此我們可以靶向 B 細胞,也可以靶向 NK 細胞。
And so we see this really as the leading edge of a very exciting broad platform that builds on our knowledge of the multispecific platforms. So -- and the one other application that Elias didn't mention is that obviously, it can be used for gene correction using CRISPR recombinases to modulate or make sure the DNA is permanently kept or in other cases, transiently expressed.
因此我們把這視為一個非常令人振奮、廣泛平台的前沿,建立在我們對多特異性平台的知識之上。所以——另外一個 Elias 沒提到的應用是,顯然它也可用於透過 CRISPR 重組酶進行基因校正,以調控或確保 DNA 被永久保留,或在其他情況下僅短暫表達。
So it's just a very fertile area. And the only other thing I would emphasize because I think we implied it, but didn't come out and say it is that we're planning to do the initial studies using the IIT mechanism in China, which allows us to go faster, allows us to do -- for us to be more efficient and for us to also do it with lower cost. So it will accelerate our efforts there.
所以這確實是一個非常肥沃的領域。另外我想強調的唯一一點是,因為我覺得我們有暗示到,但沒有直接說出來:我們計畫在中國透過 IIT 機制來進行初始研究,這讓我們能更快推進、讓我們更有效率,也能以更低成本完成。因此這將加速我們在那裡的工作。
And that's where when Elias was talking about the preclinical package, we also have some safety data that we will be providing the investigators who will be conducting the study. But everything is on track, and we're very excited about it because it's a whole new world in terms of both antibodies and gene delivery.
這也就是當 Elias 談到臨床前資料包時,我們也有一些安全性資料會提供給將執行該研究的研究者。但一切都按計畫進行,我們非常興奮,因為在抗體與基因遞送方面,這是一個全新的世界。
Kevin DeGeeter - Analyst
Kevin DeGeeter - Analyst
No, thank you for all that feedback. That's all for our questions today.
不,謝謝你們所有這些回饋。我們今天的提問就到這裡。
Gary Nabel - Chief Innovation Officer, Director
Gary Nabel - Chief Innovation Officer, Director
Thank you so much.
非常感謝。
Operator
Operator
Yale Jen, Laidlaw & Co.
Yale Jen,Laidlaw & Co.。
Yale Jen - Analyst
Yale Jen - Analyst
Good afternoon and thanks for taking the questions. Just we have two here. The first one is in terms -- based on the guidance for the 2026, we believe the Diagnostic business seems having a continuous growth quarter-over-quarter in that pattern. So you mentioned about the 4Kscore. Would there be any other aspect of factors also could drive the revenue growth on that operation? And we have a follow-up.
下午好,謝謝讓我提問。我這裡有兩個問題。第一個是——根據 2026 年的指引,我們認為診斷業務似乎呈現按季(quarter-over-quarter)持續成長的趨勢。你提到了 4Kscore。除了這個之外,是否還有其他因素也能推動該業務的營收成長?我還有一個追問。
Adam Logal - Chief Financial Officer, Senior Vice President, Chief Accounting Officer, Treasurer
Adam Logal - Chief Financial Officer, Senior Vice President, Chief Accounting Officer, Treasurer
Yeah. So, Yale, the main drivers beyond 4K is really the first full year of the focus on the New York, New Jersey market. So the commercial team has been very aggressive in identifying new opportunities and growth opportunities in those markets. It's all still within the typical clinical and women's health portions of the business. There are some adjacent lines that we continue to explore and work towards, but it is core accounts being one in the market, and we have a very rich and deep pipeline the team is executing against.
是的。所以,Yale,除了 4K 之外的主要驅動因素,確實是我們在紐約、紐澤西市場聚焦的第一個完整年度。因此商業團隊非常積極地在這些市場中辨識新的機會與成長機會。這仍然都在該業務典型的臨床與女性健康範疇之內。我們持續探索並推進一些相鄰的產品線,但主要仍是核心客戶在市場中的拓展,而且團隊正在執行一個非常豐富且深厚的專案管線。
Yale Jen - Analyst
Yale Jen - Analyst
Okay. Great. And maybe just one question for MDX2001. Given that Trop1 is one of the targets, just curious at this stage, is the triple-negative breast cancer one of the targets? Or how should we think about the next stage in terms of the target selection, tumor type selection and development?
好的。很好。另外想問一個關於 MDX2001 的問題。鑑於 Trop1 是其中一個靶點,我想了解在這個階段,三陰性乳癌是否是其中一個目標?或者我們應該如何看待下一階段在靶點選擇、腫瘤類型選擇與開發方面的規劃?
Elias Zerhouni - President, Vice Chairman of the Board
Elias Zerhouni - President, Vice Chairman of the Board
Yeah. so as you know, we're doing trials in patients who have -- who are not responding to other tumors. Triple-negative breast cancer also has high expression of Trop2 and cMet. So it is part of our list of 14 cancers that could be responsive. But we're going to focus on the ones that have shown promising responses, but we haven't had a lot of triple negatives in our population so far.
是的。如你所知,我們正在對那些——對其他治療沒有反應的腫瘤患者進行試驗。三陰性乳癌也有 Trop2 與 cMet 的高表達。因此它在我們列出的 14 種可能有反應的癌症清單之中。但我們會聚焦在那些已顯示出有前景反應的類型;只是到目前為止,我們的受試人群中三陰性病例不多。
And so we hope to have them and eventually grow that population when we get into the Phase Ib, the next phase. We are also trying to enrich the population right now that we are near or at the right regimen and dose. So that's certainly a tumor that we'd like to have more of in our samples, but it is theoretically possible to have an effect on triple-negative breast cancer.
因此我們希望能納入更多,並在進入 Ib 期、下一階段時擴大該族群。我們目前也在嘗試富集(enrich)受試人群,因為我們已接近或達到合適的給藥方案與劑量。所以這當然是我們希望在樣本中增加比例的一種腫瘤;但理論上確實可能對三陰性乳癌產生效果。
Yale Jen - Analyst
Yale Jen - Analyst
And maybe just to refresh my memory, when we should anticipate the next data readout for MDX2001? Thanks.
另外想請你幫我回憶一下,我們應該何時預期 MDX2001 的下一次數據讀出?謝謝。
Elias Zerhouni - President, Vice Chairman of the Board
Elias Zerhouni - President, Vice Chairman of the Board
Well, like I said, we're finishing the dose escalation and the regimen and how do you do this? When you do immuno-oncology, as you know, there's not a one-size-fits-all protocol. There's step dosing that you use or you don't use steroids and then at what level you really do the interval, one week. Also, we are developing because we are very encouraged by what we see with our IV. We're now developing the liquid formulation so we can use subcu delivery, which would be easier on the patients.
嗯,如我所說,我們正在完成劑量遞增以及給藥方案——要怎麼做?在免疫腫瘤領域,如你所知,並沒有一套放諸四海皆準的方案。你可能會使用階梯式給藥(step dosing),或不使用類固醇,然後在什麼程度上設定給藥間隔,例如一週一次。另外,我們也正在開發——因為我們對靜脈注射(IV)所看到的結果非常受鼓舞。我們現在正在開發液體配方,這樣就能採用皮下(subcu)給藥,對病人會更方便。
And so we're exploring all of that.
因此我們正在探索所有這些。
And obviously, once we finish this towards the third quarter, beginning of fourth quarter, we will have basically the plans for the Phase Ib pretty much in place by then. So at the end of the third quarter, beginning of fourth quarter, we'll be able to complete this current phase.
而且很明顯,一旦我們在第三季末、第四季初完成這部分,我們基本上到那時就會把 Ib 期的計畫大致定案。所以在第三季末、第四季初,我們將能完成目前這個階段。
Yale Jen - Analyst
Yale Jen - Analyst
Okay, great. That's very helpful and congrats on the progress.
好的,很好。這非常有幫助,也恭喜你們的進展。
Elias Zerhouni - President, Vice Chairman of the Board
Elias Zerhouni - President, Vice Chairman of the Board
Thank you.
謝謝。
Operator
Operator
Edward Tenthoff, Piper Sandler.
Edward Tenthoff,Piper Sandler。
Edward Tenthoff - Analyst
Edward Tenthoff - Analyst
Great. And excited about everything going on at OPKO. Looking forward to the in vivo data at ASGCT and MDX2001 data in the second half. One quick question. Did you say you would run the Phase I study for in vivo in China?
很好。也對 OPKO 正在進行的一切感到振奮。期待在 ASGCT 看到體內(in vivo)數據,以及下半年 MDX2001 的數據。一個簡短問題。你剛才是說體內(in vivo)的一期研究會在中國進行嗎?
And is that with a partner? Or are you partnering with a specific university there? Thanks.
那是和合作夥伴一起做嗎?還是你們會與那邊某所特定大學合作?謝謝。
Elias Zerhouni - President, Vice Chairman of the Board
Elias Zerhouni - President, Vice Chairman of the Board
I'm sorry, I couldn't hear. Which product are you talking about?
抱歉,我聽不清楚。你在問的是哪一個產品?
Edward Tenthoff - Analyst
Edward Tenthoff - Analyst
In vivo-
體內—
Elias Zerhouni - President, Vice Chairman of the Board
Elias Zerhouni - President, Vice Chairman of the Board
For in vivo, the in vivo CAR-T-
就體內而言,體內 CAR-T—
Gary Nabel - Chief Innovation Officer, Director
Gary Nabel - Chief Innovation Officer, Director
In vivo CAR-T, I think he's referring to.
體內 CAR-T,我想他指的是這個。
Elias Zerhouni - President, Vice Chairman of the Board
Elias Zerhouni - President, Vice Chairman of the Board
Right. Yes. So we're absolutely -- we have a team actually right now there interviewing the clinical sites and with a partner, local partner. And so I don't know at this point who will -- one or two sites actually, the two sites are very interested in participating. So we are basically doing due diligence on that right now.
對。是。所以我們絕對——我們其實現在有一個團隊在那裡,正在與臨床試驗中心面談,並且與一個合作夥伴、當地合作夥伴一起進行。因此我目前還不知道會是哪一家——實際上是一到兩個中心,這兩個中心都非常有興趣參與。所以我們基本上正在就此進行盡職調查。
I can't tell you which site and when, but they are very, very anxious to really participate in this trial given the uniqueness of this particular platform.
我不能告訴你是哪個中心以及何時,但鑑於這個特定平台的獨特性,他們非常、非常急切地想要真正參與這項試驗。
Edward Tenthoff - Analyst
Edward Tenthoff - Analyst
Very neat. And when it comes to the immune rejuvenator, I appreciate it's still early, but what do you see as the regulatory path here? Is this something that you'd have to use in combination with other IO agents? And if so, does it make sense to partner with?
非常棒。另外談到免疫回春劑(immune rejuvenator),我理解目前仍在早期階段,但你認為這裡的法規路徑會是什麼?這是否必須與其他 IO 藥物聯合使用?如果是的話,是否有必要找夥伴合作?
Elias Zerhouni - President, Vice Chairman of the Board
Elias Zerhouni - President, Vice Chairman of the Board
Yeah, so this is a great question as always. So we have actually two arms in our Phase I. As we described, there's a PD-1 naive population and a PD-1 exposed population of prior exposure to PD-1. Now a lot of people, when they look at this molecule, the most common question we say, we don't have to take a cancer target.
是的,這一如既往是個很好的問題。我們的第一期試驗其實有兩個組別。如我們所描述的,有一個 PD-1 未用過(naive)族群,以及一個先前曾暴露於 PD-1 的 PD-1 暴露族群。現在很多人看這個分子時,最常見的問題是我們會說,我們不必鎖定癌症靶點。
Well, PD-1 also doesn't have a cancer target. There's a checkpoint inhibitor. The difference is that MDX2004 is an accelerator. It really enhances the response. It does not unblock the response. And when you just unblock, obviously, you may be unblocking very exhausted T cells.
嗯,PD-1 也沒有癌症靶點。它是一種免疫檢查點抑制劑。差別在於 MDX2004 是一個加速器。它真正做的是增強反應。它不是解除阻斷反應。而當你只是解除阻斷時,顯然你可能是在解除阻斷非常耗竭的 T 細胞。
And so that's why we came up with this concept of rejuvenation. So think of it as basically KEYTRUDA or an OPDIVO of a different kind, which will be combined, obviously, with other therapies at some point. But we have to show also to the FDA that a monotherapy also has an effect, and that's what we're doing right now. It's a monotherapy trial where for patients that are either naive to PD-1 or have been exposed to PD-1 but have progressed. I hope that helps you.
因此這就是我們提出「回春」這個概念的原因。所以可以把它想成是一種不同類型的 KEYTRUDA 或 OPDIVO,未來某個時間點顯然會與其他療法聯合使用。但我們也必須向 FDA 證明單藥治療也有效果,而這正是我們目前在做的。這是一項單藥試驗,針對對 PD-1 尚未用過的患者,或曾暴露於 PD-1 但已出現疾病進展的患者。希望這能解答你的問題。
Edward Tenthoff - Analyst
Edward Tenthoff - Analyst
Very much. And then lastly, did I hear correctly that the plan was to advance subcu oxyntomodulin before advancing the oral formulation? In other words, sort of seeing what you learn from subcu first and then taking the oral into the clinic with Entera technology?
非常有幫助。最後一個問題,我是否聽對了:計畫是在推進口服劑型之前,先推進皮下(subcu)oxyntomodulin?換句話說,先從皮下劑型學到一些東西,再把採用 Entera 技術的口服劑型帶入臨床?
Elias Zerhouni - President, Vice Chairman of the Board
Elias Zerhouni - President, Vice Chairman of the Board
That is [Dr. Shao] runs the program, and that is exactly what is happening. We need to understand better with the Phase I/IIa, the behavior of the drug in an injectable format. So then once we fix that range, then you can really do the implementation of the oral because then you know what to target in terms of PK, in terms of area under the curve and Cmax and side effects and so on. So we decided -- and Dr.
這個專案由 [Dr. Shao] 負責,而目前的進展正是如此。我們需要透過第一期/第二期 a 的研究,更好地理解藥物在注射劑型下的表現。如此一來,一旦我們確定了那個範圍,你就能真正推動口服劑型的落地,因為你會知道在藥物動力學(PK)、曲線下面積(AUC)與 Cmax,以及副作用等方面應該以什麼為目標。所以我們決定——而且 Dr.
Shao decided it was better to get that information first instead of having many, many different approaches and dosing with the oral. So we think it would simplify, in fact, the path to oral.
Shao 決定先取得這些資訊會更好,而不是在口服劑型上採用許多、許多不同的方法與劑量設計。因此我們認為這其實會簡化走向口服的路徑。
Edward Tenthoff - Analyst
Edward Tenthoff - Analyst
Great. That's super helpful. Thanks, guys.
太好了。這非常有幫助。謝謝各位。
Elias Zerhouni - President, Vice Chairman of the Board
Elias Zerhouni - President, Vice Chairman of the Board
Thank you.
謝謝。
Operator
Operator
Michael Petusky, Barrington Research.
Michael Petusky,Barrington Research。
Michael Petusky - Analyst
Michael Petusky - Analyst
So I think, Adam, I think you referred to in terms of the Diagnostic business, one of the drivers in the second half would be opportunities that, that team is pursuing and sort of in a focused way in New York, New Jersey. Do you guys have line of sight of new business pieces that may be starting midyear? Or like is there -- are there data points that you guys have put together or is essentially, hey, at this point, these guys are sort of getting after it?
所以我想,Adam,我想你提到就診斷業務而言,下半年的一個驅動因素會是那個團隊正在追求的機會,並且在紐約、新澤西以更聚焦的方式推進。你們是否已經能掌握可能在年中開始的新業務項目?或者說——你們是否整理出一些數據點?還是基本上就是:目前這些人正在全力以赴?
Adam Logal - Chief Financial Officer, Senior Vice President, Chief Accounting Officer, Treasurer
Adam Logal - Chief Financial Officer, Senior Vice President, Chief Accounting Officer, Treasurer
So thanks for the question, Mike. So you're right. So the team is pretty mature in a lot of the onboarding of the accounts that are required to hit the numbers, and we feel confident we didn't change our full year outlook. For the quarter, we show -- or for the year, we showed quarter-over-quarter growth. The -- some of that growth is coming from 4K, but a lot of it is coming from the traditional business that we have a very clear line of sight to.
謝謝你的問題,Mike。你說得沒錯。團隊在為達成目標所需的客戶導入(onboarding)方面已相當成熟,我們也有信心,因此沒有調整我們的全年展望。就本季而言,我們呈現——或就全年而言,我們呈現了季度對季度的成長。——其中一部分成長來自 4K,但很大一部分來自我們的傳統業務,而我們對此有非常清晰的能見度。
Michael Petusky - Analyst
Michael Petusky - Analyst
Okay. Great. And then just sort of sticking with the same segment. In terms -- I think you guys referred to that there was a little bit of a headcount reduction. I think you were talking about in Q1 in that business.
好的。很好。接著同樣聚焦在這個部門。就——我想你們提到有小幅的人力縮減。我想你們是在談該業務第一季的情況。
As you sort of look out, are there other cost and expense reduction initiatives that you would anticipate throughout the remainder of the year?
展望未來,你們是否預期在今年剩餘期間還會有其他成本與費用削減措施?
Adam Logal - Chief Financial Officer, Senior Vice President, Chief Accounting Officer, Treasurer
Adam Logal - Chief Financial Officer, Senior Vice President, Chief Accounting Officer, Treasurer
Yeah, Elias mentioned the 4% headcount reduction that happened in the first quarter of this year. We -- unlike prior years where we had major cost-out initiatives that we executed against, a lot of this year is really turning into operating efficiencies. So ensuring that we've got the right counts of people doing the right things. But there's no significant cost-out plan to achieve the results.
是的,Elias 提到今年第一季發生了 4% 的人力縮減。我們——不同於過去幾年我們執行過的大型降本計畫,今年更多是轉向營運效率的提升。也就是確保我們有適當的人數,做正確的事情。但沒有為了達成結果而設定重大的降本計畫。
It's continuing achieving the operating efficiency that we're targeting. And I think the quarterly or sequential improvements will continue to show that.
我們會持續達成我們所鎖定的營運效率。我認為季度或序列性的改善也會持續反映這一點。
Michael Petusky - Analyst
Michael Petusky - Analyst
All right, great, very good. Thank you.
好的,很好,非常好。謝謝。
Operator
Operator
This concludes our question-and-answer session. I would like to turn the conference back over to Dr. Frost for any closing remarks.
我們的問答環節到此結束。我想把會議交回給 Frost 醫師,請他做結語。
Phillip Frost - Chairman of the Board, Chief Executive Officer
Phillip Frost - Chairman of the Board, Chief Executive Officer
I want to thank everybody for participating and for the good questions that we've been able to answer. We look forward to meeting with you again to discuss the results of the next quarter. So with that note, I wish you a good evening. Thank you.
我要感謝大家的參與,以及你們提出的好問題,讓我們得以回答。我們期待再次與各位會面,討論下一季度的業績結果。那麼在此,我祝各位晚安。謝謝。
Operator
Operator
Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect. Thank you.
謝謝。本次電話會議現在結束。感謝各位參加今天的簡報。您現在可以斷線。謝謝。