OPKO Health Inc (OPK) 2025 Q1 法說會逐字稿

Good afternoon, and welcome to the OPKO Health first-quarter 2025 financial results conference call. (Operator Instructions) Please note, this event is being recorded. I would now like to turn the conference over to Yvonne Briggs. Please go ahead.

下午好，歡迎參加 OPKO Health 2025 年第一季財務業績電話會議。（操作員指示）請注意，此事件正在被記錄。現在我想將會議交給伊馮娜·布里格斯。請繼續。

Thank you, operator. 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 2025. 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, will be subject to risks and uncertainties that could materially affect the company's expected results.

謝謝您，接線生。午安.我是 Alliance Advisors IR 的 Yvonne Briggs。感謝大家參加今天的電話會議，討論 OPKO Health 2025 年第一季的財務表現。我想提醒大家，管理階層在本次電話會議上所作的任何除歷史事實陳述以外的陳述都將被視為前瞻性陳述，因此將受到可能對公司預期業績產生重大影響的風險和不確定性的影響。

Those forward-looking statements include, but 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, 2024, and in subsequently filed SEC reports.

這些前瞻性陳述包括但不限於本公司提交給美國證券交易委員會 (SEC) 的文件中所述的各種風險，包括截至 2024 年 12 月 31 日的 10-K 表格年度報告以及隨後提交給美國證券交易委員會的報告中。

Furthermore, this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast on April 30, 2025. 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. Before we begin, let me review the format for today's call.

此外，本次電話會議包含時間敏感訊息，僅截至 2025 年 4 月 30 日現場直播之日準確。除法律要求外，OPKO 不承擔修改或更新任何前瞻性陳述以反映本次電話會議日期之後的事件或情況的義務。在我們開始之前，讓我回顧一下今天電話會議的形式。

Dr. Phillip Frost, Chairman and Chief Executive Officer, will open the call. Dr. Elias Zerhouni, Vice Chairman and President, will then provide an overview of BioReference Health as well as OPKO's Pharmaceutical business. 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 up the call to questions.

董事長兼執行長菲利普·弗羅斯特博士將主持此次電話會議。隨後，副董事長兼總裁 Elias Zerhouni 博士將概述 BioReference Health 以及 OPKO 的製藥業務。之後，OPKO 財務長 Adam Logal 將回顧該公司第一季的財務業績，並討論 OPKO 的財務前景，然後我們將開始提問環節。

Now I'd like to turn the call over to Dr. Frost.

現在我想把電話轉給弗羅斯特醫生。

Good afternoon, and thank you for joining us today. We continue to advance our strategic initiatives to drive value for OPKO Health. In March, we announced the sale of BioReference's Health Oncology and related clinical testing business to LabCorp.

下午好，感謝您今天加入我們。我們將繼續推進我們的策略性舉措，為 OPKO Health 創造價值。三月份，我們宣布將 BioReference 的健康腫瘤學和相關臨床測試業務出售給 LabCorp。

BioReference will continue to offer Urology Diagnostic Services nationwide as well as maintain its core clinical testing operations in New York and New Jersey, which collectively represented approximately $320 million in revenue for 2024. This transaction is our second with LabCorp and it unlocks additional value in our Diagnostics segment and enhances BioReference's path to profitability.

BioReference 將繼續在全國範圍內提供泌尿科診斷服務，並維持其在紐約和新澤西的核心臨床檢測業務，2024 年這兩項業務的總收入約為 3.2 億美元。這是我們與 LabCorp 的第二次交易，它為我們的診斷部門釋放了額外的價值，並增強了 BioReference 的獲利能力。

Our dual-GLP-1/Glucagon [agonist,] OPKO 88006 (sic - "OPK-88006") administered subcutaneously has demonstrated encouraging outcomes in animal models of obesity and NASH. The positive improvements of metabolic parameters, hepatic pathology, and nonalcoholic fatty liver disease activity score, including fibrosis stage, support our decision to develop OPK-88006 as a once-weekly subcutaneous injectable treatment of NASH.

我們的雙 GLP-1/胰高血糖素 [激動劑] OPKO 88006（原文如此 - “OPK-88006”）皮下注射已在肥胖和 NASH 動物模型中顯示出令人鼓舞的結果。代謝參數、肝臟病理學和非酒精性脂肪肝疾病活動評分（包括纖維化階段）的積極改善支持我們決定將 OPK-88006 開發為每週一次的皮下注射 NASH 治療方法。

In March, we entered into a collaborative agreement with Entera Bio to advance the development of an oral tablet form of OPKO-88006 (sic - "OPK-88006"). Using Entera's proprietary N-Tab technology, oral bioavailability studies in several animal models suggest that therapeutic levels can be achieved for human use.

三月份，我們與 Entera Bio 達成合作協議，推進 OPKO-88006 口服片劑（原文如此 - “OPK-88006”）的開發。使用 Entera 專有的 N-Tab 技術，在幾種動物模型中進行的口服生物利用度研究表明，該藥物可達到人類使用的治療水平。

ModeX has two programs in Phase 1 clinical trials. Our Epstein-Barr virus vaccine candidate in collaboration with Merck and MDX2001, a tetra-specific antibody for the treatment of solid tumor cancers. We look forward to keeping you updated on the progress of these trials.

ModeX 有兩個項目處於第一階段臨床試驗階段。我們與默克合作研發的愛潑斯坦-巴爾病毒候選疫苗和MDX2001，這是一種用於治療實體腫瘤癌症的四特異性抗體。我們期待向您通報這些試驗的進展。

Our Latin American business and EirGen Pharma, our Irish contract pharmaceutical development and manufacturing unit, continue to show revenue and profit growth. As we continue to advance our strategy for each business segment, we're confident in our ability to drive value for OPKO shareholders.

我們的拉丁美洲業務和愛爾蘭合約藥品開發和製造部門 EirGen Pharma 繼續顯示收入和利潤成長。隨著我們不斷推進每個業務部門的策略，我們有信心為 OPKO 股東創造價值。

In addition to the BioReference asset sale, the Board approved a $100 million increase to our common stock repurchase program, bringing the total to $200 million.

除了 BioReference 資產出售之外，董事會還批准將我們的普通股回購計畫增加 1 億美元，使總額達到 2 億美元。

We believe OPKO shares continue to be significantly undervalued and our strong cash position provides the ability to return capital to shareholders while adequately funding our pharmaceutical programs. In addition, we entered into a note exchange agreement to bolster our capital structure. Adam will provide details on the agreement and related benefits in a moment. Now I'll turn the call over to Elias.

我們認為 OPKO 的股價仍然被嚴重低估，我們強大的現金狀況使我們能夠向股東返還資本，同時為我們的製藥項目提供充足的資金。此外，我們也簽訂了票據交換協議，以增強我們的資本結構。亞當稍後將提供有關該協議和相關福利的詳細資訊。現在我將把電話轉給 Elias。

Well thank you, Phil, and thank you all for joining today. Let me start with the Diagnostics segment where our restructuring efforts are continuing. First, as mentioned by Phil, we signed a definitive agreement with LabCorp to sell the oncology and related clinical testing assets of BioReference Health.

好吧，謝謝你，菲爾，也謝謝大家今天的參加。讓我先從診斷部門開始，我們的重整工作仍在繼續。首先，正如 Phil 所提到的，我們與 LabCorp 簽署了最終協議，出售 BioReference Health 的腫瘤學和相關臨床測試資產。

The transaction includes the sale of BioReference's laboratory testing businesses focused on oncology and oncology-related clinical testing services for up to $225 million, including $192.5 million payable at closing and up to $32.5 million in an earn-out based on performance.

這筆交易包括出售 BioReference 專注於腫瘤學和腫瘤學相關臨床檢測服務的實驗室檢測業務，售價高達 2.25 億美元，其中包括交易結束時支付的 1.925 億美元和根據業績支付的最高 3,250 萬美元。

Although our oncology business has grown over the years, its scale was not sufficiently large to support its costs, hence, our decision to divest from this line of business, which will improve profitability of the remaining business of BioReference.

儘管我們的腫瘤業務多年來不斷發展，但其規模不足以支撐其成本，因此我們決定剝離該業務線，這將提高 BioReference 剩餘業務的盈利能力。

BioReference will continue to offer Urology Diagnostic Services, including our proprietary 4Kscore test for prostate cancer assessment nationwide and our corrections clinical services nationwide as well as maintain its core clinical testing operations in New York and New Jersey, which represented approximately $320 million in revenues for 2024. And the transaction is anticipated to close in the second half of 2025.

BioReference 將繼續提供泌尿科診斷服務，包括我們在全國範圍內專有的用於前列腺癌評估的 4Kscore 測試和我們在全國範圍內的矯正臨床服務，並維持其在紐約和新澤西的核心臨床測試業務，這代表著 2024 年約 3.2 億美元的收入。該交易預計將於 2025 年下半年完成。

Overall, business volume at BioReference, excluding oncology, grew modestly Q1 '25 versus Q1 '24, while our 4Kscore test reported another impressive quarter with 14.5% growth year over year. BioReference continues to make progress in driving efficiencies and aligning operations with current volumes.

總體而言，BioReference 的業務量（不包括腫瘤學）在 2025 年第一季與 2024 年第一季相比略有增長，而我們的 4Kscore 測試報告顯示，該季度又取得了令人印象深刻的同比增長 14.5%。BioReference 在提高效率和使營運與當前產量保持一致方面不斷取得進展。

In Q1 2025, we made great strides in continuing both the reduction of employee costs and footprint consolidation. Specifically, during this quarter, the first quarter, BioReference eliminated an additional 136 positions, which represents about a 7% workforce reduction.

2025 年第一季度，我們在持續降低員工成本和整合足跡方面取得了長足的進步。具體來說，在本季度，即第一季度，BioReference 又裁減了 136 個職位，這意味著員工人數減少了約 7%。

Total cost savings from actions initiated during Q1 are estimated at approximately $19 million on an annualized run rate; $14 million for employee costs and $5 million in footprint consolidation. Our current headcount now stands at 1,962, which is down from a high of 3,099 in Q1 2024. And once the oncology transaction is closed in Q3, Q4, our headcount will stand at about 1,600 with revenue of about $320 million.

以年化運行率計算，第一季採取的行動所節省的總成本估計約為 1,900 萬美元； 1,400 萬美元用於員工成本，500 萬美元用於足跡整合。我們目前的員工人數為 1,962 人，較 2024 年第一季的 3,099 人有所下降。一旦腫瘤學交易在第三、第四季完成，我們的員工人數將達到約 1,600 人，收入約為 3.2 億美元。

We continue to reengineer operations in our main laboratory with automation and other approaches for greater efficiency and service levels. Our stated objective, as we had mentioned before, remains to reach profitability within this year.

我們繼續利用自動化和其他方法重新設計主實驗室的運營，以提高效率和服務水準。正如我們之前提到的，我們的目標仍然是在今年內獲利。

On the commercial front, BioReference strategically expanded its patient access service center locations during the first quarter in the New Jersey, New York area, adding infrastructure in key geography in the New York, New Jersey market. And this will not only add revenue to the organization, but will also improve the patient and client experience in the region.

在商業方面，BioReference 在第一季策略性地擴大了在新澤西州和紐約州地區的患者訪問服務中心位置，並在新澤西州和紐約州市場的關鍵地區增加了基礎設施。這不僅會增加組織的收入，還會改善該地區的患者和客戶體驗。

In addition, BioReference continued its work to enter new clinical markets by enhancing its service levels and test offerings, including, for example, respiratory pathogens and recently FDA-approved self-collection options for sexual health.

此外，BioReference 繼續致力於進入新的臨床市場，提高其服務水平和測試產品，例如呼吸道病原體和最近 FDA 批准的性健康自我收集選項。

Now let me go to the Therapeutic segment. ModeX continues its advances in clinical development. As you've heard from Phil, enrollment and dosing are well underway by our partner, Merck, in the Phase 1 Epstein-Barr virus vaccine trial.

現在讓我進入治療部分。ModeX 在臨床開發方面持續取得進展。正如您從菲爾那裡聽說的那樣，我們的合作夥伴默克公司正在第一階段的愛潑斯坦-巴爾病毒疫苗試驗中順利進行招募和給藥。

This investigational vaccine based on ModeX's ferritin nanoparticle vaccine platform is being evaluated for safety and tolerability in up to 200 healthy adults and commencement of this study triggered a milestone payment to ModeX in Q4 2024.

這款基於 ModeX 鐵蛋白奈米顆粒疫苗平台的試驗性疫苗正在對多達 200 名健康成年人進行安全性和耐受性評估，該研究的開始引發了 2024 年第四季度向 ModeX 支付里程碑付款。

In addition, ModeX continues to advance its immuno-oncology and immunology portfolio with four potential clinical candidates progressing in the pipeline. The MDX2001, which is a CMet-Trop2/CD3-CD28 tetraspecific antibody has advanced in Phase 1 clinical trials to its fourth dose level, with additional -- continuing Phase 1 and additional Phase 1B studies in selected solid tumors expected in early 2026.

此外，ModeX 繼續推進其免疫腫瘤學和免疫學產品組合，目前有四種潛在的臨床候選藥物正在研發中。MDX2001 是 CMet-Trop2/CD3-CD28 四特異性抗體，其 1 期臨床試驗已進入第四個劑量水平，預計將於 2026 年初在選定的實體瘤中繼續進行額外的 1 期和 1B 期研究。

The MDX2003 products CD19, CD20, CD3, CD28, tetraspecific antibody for lymphoma and leukemia and the MDX2004, which is an immune rejuvenator for multiple oncology and immunology indications are both expected to begin human trials in late-2025, early-2026.

MDX2003 產品 CD19、CD20、CD3、CD28（針對淋巴瘤和白血病的四特異性抗體）和 MDX2004（針對多種腫瘤學和免疫學適應症的免疫再生劑）預計均將於 2025 年末或 2026 年初開始人體試驗。

The development of multi-specific antibodies for immune-impaired patients at risk for COVID and influenza A and B continues to progress with support from BARDA, which increased its previous commitment of $59 million by another $51 million in Q4 2024 for a total of $110 million to advance these programs and the related multi-specific antibodies platform.

在 BARDA 的支持下，針對有感染 COVID 和甲型和乙型流感風險的免疫功能低下患者的多特異性抗體的開發工作繼續取得進展，BARDA 在 2024 年第四季度將其先前承諾的 5900 萬美元增加了 5100 萬美元，總計 1.1 億美元用於推進這些項目和相關的多特異性抗體平台。

There's a remaining $95 million commitment dependent upon reaching some milestones, which is still committed by BARDA. I'd like to add here that still to-date, we have not received any indication that BARDA will defund these grants in these programs as we stand here today.

剩餘的 9,500 萬美元承諾取決於是否達到某些里程碑，這筆資金仍由 BARDA 承擔。我想補充一點，到目前為止，我們還沒有收到任何跡象表明 BARDA 將停止為這些項目提供資金。

And we're hopeful that they will not, because COVID antibodies are different than COVID vaccines and COVID antibodies are needed for the immune-impaired population. As Phil mentioned, we have advanced into the pre-IND stage with our injectable proprietary GLP-1/Glucagon long-acting oxyntomodulin analog, OPK-88006.

我們希望他們不會，因為 COVID 抗體與 COVID 疫苗不同，免疫功能低下的人需要 COVID 抗體。如 Phil 所提到的，我們的注射以專有 GLP-1/胰高血糖素長效胃泌酸調節素類似物 OPK-88006 已進入 IND 前階段。

Given very promising preclinical data, for example, the study in male GAN DIO-MASH mice demonstrated improved metabolic and biochemical parameters and hepatic pathology with improved nonalcoholic fatty liver disease activity score called NAS by over 2 points, supported by quantitative liver histology for steatosis, inflammation and fibrosis showing improvements.

例如，鑑於非常有希望的臨床前數據，對雄性 GAN DIO-MASH 小鼠的研究表明其代謝和生化參數以及肝髒病理學得到改善，非酒精性脂肪肝疾病活動評分 (NAS) 提高了 2 分以上，脂肪變性、發炎和纖維化的定量肝臟組織學也顯示出改善。

We also entered into a collaboration agreement with Entera Bio to advance an oral tablet of the OPK-88006 GLP-1/Glucagon agonist into the clinic to treat obesity and metabolic disorders using Entera's N-Tab technology.

我們也與 Entera Bio 達成合作協議，將 OPK-88006 GLP-1/胰高血糖素激動劑口服錠劑推進到臨床，利用 Entera 的 N-Tab 技術治療肥胖症和代謝紊亂。

Under the terms of the agreement, OPKO and Entera will hold 60% and 40% ownership interest, respectively, in the orally administered product and be responsible for 60% and 40%, respectively, of the program's development costs.

根據協議條款，OPKO 和 Entera 將分別持有該口服產品 60% 和 40% 的所有權，並分別承擔該專案 60% 和 40% 的開發成本。

In connection with the execution of the agreement, OPKO purchased approximately 3.7 million ordinary shares of Entera for a purchase price equal to $2.17 per share for about $8 million. Entera agreed to utilize the proceeds from this share purchase to fund its 40% share of the program's development costs through the completion of Phase 1.

在執行該協議的過程中，OPKO 以每股 2.17 美元的收購價收購了 Entera 約 370 萬股普通股，總價值約 800 萬美元。Entera 同意利用此次股份收購所得來資助其在該專案第一階段完成前 40% 的開發成本。

Our RAYALDEE team continued to produce new analyses and peer-reviewed publications suggesting that RAYALDEE in CKD patients with secondary hyperparathyroidism may significantly delay the need for dialysis relative to other vitamin D products, potentially increasing its utilization in this group of patients.

我們的 RAYALDEE 團隊繼續進行新的分析並發表同行評審的出版物，表明患有繼發性副甲狀腺功能亢進症的 CKD 患者使用 RAYALDEE 可能會比其他維生素 D 產品顯著延遲透析的需要，從而有可能增加其在這類患者中的利用率。

In summary, we believe BioReference is now in a position of strength with a clear focus on its core testing capabilities, streamlined operations and expectations of profitability later this year. In addition, we're pleased with the progress of our Pharmaceutical segment in advancing our therapeutic and vaccine candidates through the clinic.

總而言之，我們相信 BioReference 目前處於優勢地位，明確專注於其核心測試能力、精簡的營運和今年稍後的獲利預期。此外，我們對製藥部門在臨床推進治療和疫苗候選方面的進展感到滿意。

Let me now turn it over to Adam Logal for our financial report and further information. Adam?

現在，我把我們的財務報告和更多資訊交給 Adam Logal。亞當？

Thank you, Elias. Starting with operating results from our Diagnostics segment, revenue was $102.8 million in Q1 2025, including $25.1 million from the assets being sold to LabCorp compared with $126.9 million for the 2024 period. This decrease was primarily the result of the first LabCorp transaction that closed in September 2024.

謝謝你，伊萊亞斯。從我們診斷部門的經營業績開始，2025 年第一季的營收為 1.028 億美元，其中包括出售給 LabCorp 的資產的 2,510 萬美元，而 2024 年同期的營收為 1.269 億美元。這一下降主要是由於 2024 年 9 月完成的首筆 LabCorp 交易所致。

During the first quarter of 2025, costs and expenses totaled $126.8 million including $32.4 million related to the assets being sold to LabCorp. This compares with $161.3 million for the comparable period of 2024.

2025 年第一季度，成本和費用總計 1.268 億美元，其中包括與出售給 LabCorp 的資產相關的 3,240 萬美元。相較之下，2024 年同期為 1.613 億美元。

Q1 2025 also includes approximately $7.2 million in nonrecurring costs and expenses for severance and facility closures, all incurred as expected as we realign our business to ensure sustainable growth and profitability.

2025 年第一季還包括約 720 萬美元的非經常性成本以及遣散費和設施關閉費用，所有這些都是在我們重新調整業務以確保可持續增長和盈利能力時按預期發生的。

As Elias mentioned, the actions taken to date will result in annualized cost savings of more than $19 million, which we will benefit from starting in May. During the first quarter of 2025, operating loss was $23.9 million compared with an operating loss of $34.4 million for the 2024 quarter. Depreciation and amortization expenses for the Diagnostics segment were $5.7 million and $7.9 million for the 2025 and 2024 periods, respectively.

正如 Elias 所提到的，迄今為止的行動將帶來每年超過 1,900 萬美元的成本節約，我們將從 5 月開始受益。2025 年第一季，營業虧損為 2,390 萬美元，而 2024 年第一季的營業虧損為 3,440 萬美元。診斷部門的折舊和攤提費用在 2025 年和 2024 年分別為 570 萬美元和 790 萬美元。

Moving to our Pharmaceutical segment. Revenue was $47.1 million for the first quarter of 2025 compared with $46.8 million to the 2024 period. Revenue from products, including our international pharmaceutical businesses was $34.8 million compared with $38.1 million for the comparable 2024 period.

轉到我們的製藥部門。2025 年第一季的營收為 4,710 萬美元，而 2024 年第一季的營收為 4,680 萬美元。包括我們的國際製藥業務在內的產品收入為 3,480 萬美元，而 2024 年同期為 3,810 萬美元。

In response to the challenging foreign currency environment that has impacted revenue, the profitability of this business continues to meet our expectations through disciplined operating expense constraints. Product revenue includes revenue of RAYALDEE of $6.3 million, which was slightly lower than 2024's $6.9 million. The Inflation Reduction Act has resulted in challenging environment for RAYALDEE.

面對影響收入的嚴峻外匯環境，透過嚴格的營運費用限制，該業務的獲利能力繼續滿足我們的預期。產品收入包括RAYALDEE的收入630萬美元，略低於2024年的690萬美元。《通貨膨脹削減法案》為 RAYALDEE 帶來了嚴峻的經營環境。

However, we have realized an increase in the operating margins for RAYALDEE as a result of the improved net pricing through lower government rebates, partially offsetting the volume decreases. Revenue from the transfer of IP was $12.3 million for the first quarter of 2025 compared to $8.7 million for the same quarter of 2024.

然而，由於政府退稅降低導致淨價格提高，RAYALDEE 的營業利潤率有所提高，部分抵消了銷量的下降。2025 年第一季智慧財產權轉讓收入為 1,230 萬美元，而 2024 年同期為 870 萬美元。

Our gross profit share from Pfizer was $4.5 million during the 2025 quarter versus $5.6 million for the 2024 period. We continue to follow the publicly available prescription data reported by third-party services and remain encouraged by the growth rates. However, we are working with Pfizer to better understand some of the underlying dynamics that have negatively impacted the first quarter profit share payments.

2025 年季度，我們從輝瑞獲得的毛利為 450 萬美元，而 2024 年季度為 560 萬美元。我們繼續關注第三方服務報告的公開處方數據，並對其成長率感到鼓舞。然而，我們正在與輝瑞公司合作，以更好地了解對第一季利潤分成支付產生負面影響的一些潛在動態。

The first quarter of 2025 also includes $7 million in R&D funding compared to $2.2 million for the 2024 period, reflecting increased activities under our program supported by BARDA. Cost and expenses for our Pharmaceutical segment were $81.9 million for the first quarter of 2025 compared with $74.5 million for the 2024 period.

2025 年第一季還包括 700 萬美元的研發資金，而 2024 年同期為 220 萬美元，這反映了我們在 BARDA 支持下的項目下活動的增加。2025 年第一季度，我們製藥部門的成本和費用為 8,190 萬美元，而 2024 年同期為 7,450 萬美元。

Research and development expenses were $30.2 million compared to $21.2 million a year ago. R&D expense increased as a result of our ModeX development activities, including the Phase 1 clinical trial of our first oncology program as well as our BARDA supported programs. The resulting operating loss for the quarter ended March 31, 2025, was $34.8 million compared with an operating loss of $27.7 million for the 2024 quarter.

研發費用為 3,020 萬美元，而去年同期為 2,120 萬美元。由於我們的 ModeX 開發活動，包括我們的第一個腫瘤學項目的第一階段臨床試驗以及我們的 BARDA 支持的項目，研發費用有所增加。截至 2025 年 3 月 31 日的季度的營業虧損為 3,480 萬美元，而 2024 年季度的營業虧損為 2,770 萬美元。

Depreciation and amortization expense for the 2025 quarter decreased slightly to $17.8 million from $18 million for the 2024 quarter. Turning to our consolidated financial results. Net loss for the first quarter of 2025 was $67.6 million or $0.10 per share compared with a net loss of $81.8 million or $0.12 per share for the 2024 period. Turning to our balance sheet. We continue to work on our capital structure and allocate capital as we laid out during our last call.

2025 年季度的折舊和攤銷費用從 2024 年季度的 1,800 萬美元小幅下降至 1,780 萬美元。談到我們的合併財務表現。2025 年第一季淨虧損為 6,760 萬美元，即每股 0.10 美元，而 2024 年同期淨虧損為 8,180 萬美元，即每股 0.12 美元。轉向我們的資產負債表。我們將繼續致力於我們的資本結構，並按照上次會議的安排分配資本。

We ended Q1 2025 with approximately $450 million in cash, cash equivalents, and restricted cash. And as we noted, we fully exited our position in GeneDx during the first quarter, adding approximately $51 million to our cash balance.

截至 2025 年第一季度，我們擁有約 4.5 億美元的現金、現金等價物和受限現金。正如我們所指出的，我們在第一季完全退出了在 GeneDx 的持股，為我們的現金餘額增加了約 5,100 萬美元。

We closed on our convertible debt exchange on April 1, 2025, which used approximately $65 million in cash, and we issued approximately 121 million shares of common stock and eliminated $159.2 million of the company's outstanding convertible notes, including accrued and unpaid interests.

我們於 2025 年 4 月 1 日完成了可轉換債務交換，動用了約 6500 萬美元現金，並發行了約 1.21 億股普通股，並消除了公司 1.592 億美元的未償還可轉換票據，包括應計未付利息。

We intend to continue to reduce our remaining convertible debt, and through our recently expanded share repurchase authorization, we plan to continue to reduce the number of shares outstanding in the most capital-efficient way possible. Under our share repurchase authorization, we have approximately $159 million remaining, which at yesterday's closing price represents more than 113 million shares or more than 14% of our currently outstanding shares.

我們打算繼續減少剩餘的可轉換債務，並且透過我們最近擴大的股票回購授權，我們計劃繼續以最高效的方式減少流通股數量。根據我們的股票回購授權，我們還剩下約 1.59 億美元，以昨日的收盤價計算，這相當於超過 1.13 億股，或超過我們目前流通股的 14%。

As Elias mentioned, we anticipate closing our second transaction with LabCorp later this year, and we'll receive $192.5 million at closing and up to $225 million in total. As we look ahead, the following assumptions influence our financial guidance.

正如 Elias 所提到的，我們預計今年稍後完成與 LabCorp 的第二筆交易，交易完成時我們將獲得 1.925 億美元，總計最高可達 2.25 億美元。展望未來，以下假設將影響我們的財務指導。

For our Pharmaceuticals segment, we expect Pfizer to continue to grow sales of NGENLA and the overall hGH franchise. We assume a stable foreign currency exchange rate for our ex U.S. pharmaceutical businesses, which has recently been challenged with the large swings in certain territories.

對於我們的製藥部門，我們預計輝瑞將繼續增加 NGENLA 和整體 hGH 特許經營的銷售額。我們假設除美國以外的製藥業務的外匯匯率保持穩定，但最近某些地區的匯率大幅波動，給這項業務帶來了挑戰。

Our teams have been diligently navigating those challenges through a disciplined expense control and expect that going forward. R&D expenses will reflect higher activities related to our ModeX programs, including CMC efforts related to our first oncology trial as well as furthering our GLP-1/Glucagon development program. A portion of the increased ModeX activities will continue to be funded through our BARDA agreements.

我們的團隊一直在透過嚴格的費用控制來應對這些挑戰，並期待未來能夠繼續保持這種勢頭。研發費用將反映與我們的 ModeX 計劃相關的更高活動，包括與我們的第一次腫瘤學試驗相關的 CMC 工作以及進一步推進我們的 GLP-1/胰高血糖素開發計劃。ModeX 活動增加的一部分將繼續透過我們的 BARDA 協議獲得資助。

For our Diagnostics segment, we are executing our multiyear multiphase program to reach and improve profitability. This program continues to be focused on operational efficiencies and the reduction of fixed infrastructure costs.

對於我們的診斷部門，我們正在執行多年多階段計劃以達到並提高盈利能力。該計劃繼續專注於提高營運效率和降低固定基礎設施成本。

We expect to incur an additional $5 million in nonrecurring costs during the second quarter, which primarily reflect severance costs. We have established an additional cost reduction initiative targeting a further $10 million of annualized cost savings on top of the $20 million we discussed in our last call.

我們預計第二季將額外產生 500 萬美元的非經常性成本，主要反映遣散費。我們制定了一項額外的成本削減計劃，目標是在上次電話會議上討論的 2000 萬美元的基礎上，再實現 1000 萬美元的年度成本節約。

As a result of our recently announced transaction with LabCorp, once closed, the remaining BioReference will be cash flow positive and profitable as measured before non recurring and non cash items. In addition, we expect to realize a gain on the LabCorp transaction of approximately $100 million, which will be reflected as a reduction to operating expenses and an increase in operating income. Due to the uncertainty of the timing of closing, we are including revenue cost and expenses for the full year and we will adjust the total revenue cost and expenses once the closing date is certain.

由於我們最近宣布與 LabCorp 的交易，一旦完成，剩餘的 BioReference 將實現正現金流，並在扣除非經常性和非現金項目之前實現盈利。此外，我們預計 LabCorp 交易將實現約 1 億美元的收益，這將反映為營運費用的減少和營運收入的增加。由於結算時間的不確定性，我們將全年的收入成本和費用包括在內，一旦確定結算日期，我們將調整總收入成本和費用。

As a result, we expect the following for the full year 2025. Total revenues between $675 million and $685 million, revenue from services between $405 million and $425 million, including the revenue from the assets being sold to LabCorp of $95 million to $105 million; revenue from products between $165 million and $175 million.

因此，我們對 2025 年全年的預期如下。總收入在 6.75 億美元至 6.85 億美元之間，服務收入在 4.05 億美元至 4.25 億美元之間，其中包括出售給 LabCorp 的資產收入 9,500 萬美元至 1.05 億美元；產品收入在1.65億美元至1.7500 萬美元之間。

And other revenue between $75 million and $85 million, inclusive of the revenue from our Pfizer gross profit share, which is estimated to be between $30 million and $40 million from $35 million to $45 million and BARDA revenue of $38 million to $44 million, which was previously guided from $40 million to $48 million.

其他收入在 7500 萬美元至 8500 萬美元之間，其中包括來自輝瑞毛利潤份額的收入，預計在 3000 萬美元至 4000 萬美元之間（3500 萬美元至 4500 萬美元）以及 BARDA 收入 3800 萬美元至 4400 萬美元（此前為 400 萬美元）。

We expect costs and expenses to be between $825 million and $875 million, excluding the nonrecurring expenses related to the restructuring activities for BioReference, which are currently estimated to be between $10 million and $14 million for the full year and inclusive of costs and expenses related to the assets being sold to LabCorp of $125 million to $135 million.

我們預計成本和費用將在 8.25 億美元至 8.75 億美元之間，不包括與 BioReference 重組活動相關的非經常性費用，目前估計全年成本和費用在 1000 萬美元至 1400 萬美元之間，並包括與出售給 LabCorp 的資產相關的 1.25 億美元至 1.35 億美元的成本和成本。

R&D expense is expected to be between $120 million and $130 million, down from $120 million to $140 million, which depends on the rate of enrollment of our clinical trial and the timing for certain activities for our ModeX programs, including CMC, with $37 million to $43 million being offset from funding by BARDA. Depreciation and amortization expense is expected to be approximately $90 million.

研發費用預計在 1.2 億至 1.3 億美元之間，低於 1.2 億至 1.4 億美元，這取決於我們臨床試驗的入組率以及我們的 ModeX 計劃（包括 CMC）某些活動的開展時間，其中 3700 萬至 4300 萬美元由 BARDA 提供資金抵消。預計折舊和攤提費用約為 9,000 萬美元。

While we don't typically provide nonoperating income and expense guidance, as a result of our convertible debt exchange, we are providing guidance as we anticipate a nonrecurring other expense item related to that exchange of approximately $90 million during the second quarter of 2025, which is comprised of interest expense from debt discount, debt issuance fees, and inducement expense.

雖然我們通常不提供非營業收入和支出指導，但由於我們的可轉換債務交換，我們提供指導，因為我們預計 2025 年第二季度與該交換相關的非經常性其他費用項目約為 9000 萬美元，其中包括債務折扣的利息費用、債務發行費和誘導費用。

That concludes our prepared remarks, and thank you all for your attention. Now operator, let's open the call for questions.

我們的準備好的演講到此結束，感謝大家的關注。接線員，現在讓我們開始提問。

(Operator Instructions)

（操作員指示）

Maury Raycroft, Jefferies.

莫里‧雷克羅夫特（Maury Raycroft），傑富瑞集團（Jefferies）。

This is James on for Maury. Just to start off, what are some possible explanations for the negative dynamics for NGENLA? Is it more likely competition, access issues, or something commercial related to Pfizer?

這是詹姆斯 (James) 代替莫里 (Maury) 上場。首先，對於 NGENLA 的負面動態有哪些可能的原因？這更有可能是競爭、進入問題，還是與輝瑞相關的商業問題？

Yes. So we've seen the growth rates of the prescriptions to continue along both for NGENLA and GENOTROPIN. So we think it's more likely to do with some of the commercial environments. We don't have color further from Pfizer just yet on the dynamic there, but we're -- we expect this to be a first quarter only event, which is why we've only slightly reduced the guide.

是的。因此，我們看到 NGENLA 和 GENOTROPIN 的處方成長率持續上升。因此我們認為這更有可能與某些商業環境有關。目前，我們還沒有從輝瑞公司獲得進一步的動態信息，但我們預計這將是第一季發生的事件，這就是為什麼我們只略微降低了預期。

Got it. And could -- just to add on to that, could you also please comment on why you think Pfizer withdrew their EU application for the adult setting? When was the last time you met with Pfizer regarding plans to expand the franchise? And what are those plans for expansion into additional settings?

知道了。另外，您能否補充一下，您認為輝瑞公司撤回其針對成人環境的歐盟申請的原因是什麼？您上次與輝瑞公司會面討論擴大特許經營權的計劃是什麼時候？那麼擴展到其他環境的計畫是什麼？

Yes. So I'll try to expand on this and then Elias or others could jump in as well. So Pfizer has been working on a strategy to expand the label for NGENLA for some time. We do know that they're expecting to kick off some trials for the additional pediatric indications. Within Europe, the dynamics is slightly different.

是的。因此，我會嘗試擴展這一點，然後 Elias 或其他人也可以加入。因此，輝瑞一直在製定擴大 NGENLA 標籤的策略。我們確實知道他們希望針對額外的兒科適應症進行一些試驗。在歐洲內部，情況略有不同。

And I think that Pfizer chose to be more focused on the pediatric indication given the size of the overall market for the pediatric indications in comparison to the adult and wanted to focus their efforts there.

我認為，考慮到兒科適應症的整體市場規模與成人市場相比更大，輝瑞選擇更專注於兒科適應症，並希望將精力集中在那裡。

Yi Chen, H.C. Wainwright.

陳毅, H.C.溫賴特。

Thank you for taking my questions. Could you please provide a rough time line about development program of the GLP-1/Glucagon tablet candidate? When can we expect to see some clinical results? And also, what could be the dosing frequency in the clinical trial?

感謝您回答我的問題。您能否提供 GLP-1/胰高血糖素候選片劑開發計畫的大致時間表？我們什麼時候可以看到一些臨床結果？此外，臨床試驗中的給藥頻率是多少？

Thanks, Yi. So the time line for the development program -- we expect to have an IND filed later this year or by the end of this year or early next year with the trial to commence thereafter and could get results from a Phase 1 trial by the end of '26. And as it relates to dosing, it's expected to be a once-weekly dosing.

謝謝，Yi。因此，開發計畫的時間表是——我們預計將在今年稍後或今年年底或明年年初提交 IND，然後開始試驗，並可能在 26 年底之前獲得第一階段試驗的結果。至於劑量，預計每週服用一次。

Sorry, I was on mute. I couldn't answer before Adam took it and gave you a perfect answer.

抱歉，我靜音了。在亞當接手並給你一個完美的答案之前，我無法回答。

So apart from being an oral tablet candidate and once-a-week dosing, is there any other differentiating factor for this candidate compared to semaglutide and/or tirzepatide?

那麼，除了作為口服片劑候選藥物和每週服用一次之外，與司美格魯肽和/或替澤帕肽相比，該候選藥物還有其他區別因素嗎？

Yes. So let me take that one. First of all, for the oral formulation, it's once a day. For the subcu, it's once a week, right? Now GLP-1 and Glucagon are a pair of agonist, if you will -- Oxyntomodulin, it's an analog of Oxyntomodulin.

是的。所以讓我來選擇這個。首先，對於口服劑型來說，每天一次。對於皮下注射來說，是每週一次，對嗎？現在 GLP-1 和胰高血糖素是一對激動劑，如果你願意的話——泌酸調節素，它是泌酸調節素的類似物。

And it's really, really interesting because it does -- Glucagon acts on the liver, on the metabolism of the liver. And so it's really focused on whether or not this compound can be of use in MASH, and if all of our preclinical work indicates that it is.

這真的非常有趣，因為升糖素確實作用於肝臟，影響肝臟的新陳代謝。因此，真正關注的是這種化合物是否可用於 MASH，以及我們所有的臨床前工作是否表明它是有用的。

So if you're looking at the niche, which we think GLP-1/Glucagon will be superior is really the MASH fatty liver disease group. So that's really where we're going, and that's what we're going to try to develop over the next year.

因此，如果您正在尋找利基市場，我們認為 GLP-1/胰高血糖素將佔優勢的實際上是 MASH 脂肪肝疾病組。這就是我們真正的目標，也是明年我們要努力發展的方向。

Another way to say that, we're not going into all markets that relate to GLP-1/Glucagon. We're focusing our entry indication is going to be in the liver diseases that are affected by fatty liver disease, patients who are affected by fatty liver disease, and then we'll expand from that depending on the results we see in Phase 1 and Phase 1b.

換句話說，我們不會進入所有與 GLP-1/升血糖素相關的市場。我們的入門適應症重點在於受脂肪肝影響的肝病、受脂肪肝影響的患者，然後我們將根據第 1 階段和第 1b 階段的結果進行擴展。

Jeffrey Cohen, Ladenburg Thalmann.

傑弗瑞‧科恩、拉登堡‧塔爾曼。

Adam, can you comment -- so pro forma now, can you give us a sense of if anything is left on the convertible notes as well as the secured notes and number of shares pro forma?

亞當，您能否評論一下——那麼現在的形式是，您能否讓我們了解一下可轉換票據以及擔保票據上是否還剩下什麼，以及形式上的股份數量？

Sure. So let me just make sure I heard you right. So on the number of shares on a pro forma basis, it went from -- at March 31, it was about 671 million shares.

當然。所以請讓我確認一下我聽得對不對。因此，根據備考基礎的股票數量，截至 3 月 31 日，約為 6.71 億股。

As part of the convertible note exchange, we increased that by 121 million. So you get to just about 790 million shares, a little bit more than 790 million shares outstanding on a pro forma basis. On what's left on the convertible notes, we have approximately $129 million remaining of principal that's outstanding on an ongoing basis.

作為可轉換票據交換的一部分，我們將其增加了 1.21 億。因此，您獲得的股票數量約為 7.9 億股，比形式上的 7.9 億股流通股略多一點。就可轉換票據的剩餘部分而言，我們仍有約 1.29 億美元的本金未償還。

Okay. Got it. That's super helpful. I appreciate it. Can you give us a sense of the Diagnostics business and by reference, I know you outlined some numbers for the year.

好的。知道了。這非常有幫助。我很感激。您能否向我們介紹診斷業務？據我所知，您概述了今年的一些數據。

So we should think of that as a $300-ish million baseline business for the second half of this year as far as thinking of it on an annual basis?

那麼，從年度角度來看，我們應該將其視為今年下半年約 3 億美元的基準業務嗎？

Yes. On an annualized basis, the kind of remaining business sits between $310 million and $320 million. That's right, on an annualized basis.

是的。以年率計算，剩餘業務價值在 3.1 億美元至 3.2 億美元之間。沒錯，以年率計算。

Okay. Got it. And timing on the Q will be today or tomorrow?

好的。知道了。Q 的時間是今天還是明天？

Tomorrow evening, yes.

是的，明天晚上。

Okay. And I got all the metrics. So I think that does it for us. Thank you for answering my questions.

好的。我得到了所有的指標。所以我認為這對我們來說就足夠了。感謝您回答我的問題。

Eric Joseph, JPMorgan.

摩根大通的艾瑞克‧約瑟夫。

This is Billy on for Eric. A quick one on the EBV trial, if that's okay first. With the 200 healthy volunteers looking to be read out, are there any sort of efficacy or biomarker signals you might look for in that readout that might derisk the asset from an efficacy perspective?

這是 Billy 代替 Eric 上場的。如果可以的話，先快速進行 EBV 試驗。對於 200 名健康志願者的療效數據，您是否會在讀數中尋找任何可能從療效角度降低資產風險的功效或生物標記訊號？

So the 200 patients are divided in different cohorts because we're also using adjuvants. Merck is using adjuvant testing, different adjuvants for the vaccine, and that's what is going to be measured. We will get an idea of the immunogenicity of the vaccine with biomarkers. It's not the intent of Phase 1. It's mostly tolerability and safety.

因此，由於我們也使用佐劑，因此 200 名患者被分成不同的組別。默克公司正在使用佐劑測試，對疫苗使用不同的佐劑，這就是要測量的內容。我們將透過生物標記來了解疫苗的免疫原性。這不是第一階段的目的。主要是耐受性和安全性。

So by the end of that trial, we'll have a good idea of the potential efficacy to indirect measures.

因此，在試驗結束時，我們將對間接措施的潛在功效有一個很好的了解。

And then just a quick one, if you might, just squeeze in on the TCE candidate 2001. Is there any update on time lines as to when that safety readout might come out? And then kind of how many dosing cohorts you might expect for that first safety readout?

然後，如果可以的話，只需快速擠進 TCE 候選人 2001 即可。關於安全讀數何時發布，有沒有時間表方面的更新？那麼，您預計第一次安全讀數需要多少個給藥組呢？

So we -- the first phase was six levels. We're in the fourth. We've accomplished the fourth. We're going to fifth and sixth. Hopefully, we'll have that initial six levels, which are really important because at the end of the six, we get to what we think is the beginning of the efficacy range, even though we're observing whether or not we have results within these levels that we have now.

所以我們——第一階段有六個等級。我們排在第四名。我們已經完成了第四個。我們要去第五和第六。希望我們能夠擁有最初的六個級別，這非常重要，因為在這六個級別結束時，我們得到了我們認為的功效範圍的開始，儘管我們正在觀察我們是否在現有的這些級別內取得了成果。

And as I said before, we should be able to complete that phase before the end of this year and then enter the efficacy part of the trial, probably was still a basket trial, a few different cancers, solid cancers that -- where we have seen some signals, and then eventually [come] down in Phase 1b to 1, possibly 2 cancers that are the most promising. So that's the way the trial is designed.

正如我之前所說，我們應該能夠在今年年底之前完成該階段，然後進入試驗的療效部分，可能仍然是一個籃子試驗，針對幾種不同的癌症，實體癌 - 我們已經看到了一些信號，然後最終在 1b 階段降至 1，可能是 2 種最有希望的癌症。這就是試驗的設計方式。

Edward Tenthoff, Piper Sandler.

愛德華·坦托夫、派珀·桑德勒。

I just want to confirm and make sure I'm getting this right. But what are next steps for the subcu obesity program, MASH program? And then what is sort of the differential development plan for oral? How do you anticipate differentiating them? And what do you think the timing is for the study?

我只是想確認並確保我理解正確。但是超重肥胖計劃（MASH 計劃）的下一步是什麼？那麼口語的差異化發展計畫是什麼樣的呢？您預計如何區分它們？您認為這項研究的時機是什麼時候？

So both of them, we are working diligently to enter Phase 1. So we're in the pre-IND phase for both of them. CMC phase for both of them and they have been manufactured. We will have our GMP material ready. We're completing and interacting with the FDA about the design of these trials.

因此，我們正在努力進入第一階段。因此，我們對這兩項研究都處於 IND 前階段。二者均為 CMC 相，且均已製造完成。我們將準備好我們的 GMP 材料。我們正在完成這些試驗的設計並與 FDA 溝通。

Initially, it will pretty much be safety, as you know, with Phase 1 trials, measuring side effects, measuring dose range and so on. So it's a prep work, if you will, in view of a more advanced development in Phase 2a and 2b.

最初，如您所知，它將非常安全，透過第一階段試驗來測量副作用、測量劑量範圍等。因此，如果您願意的話，這是一項準備工作，以期在第 2a 和 2b 階段取得更先進的進展。

But what we're talking about here is Phase 1a and b to answer that question that you're just asking, what is the right PK/PD and pharmacological behavior that we need to measure before we go further in Phase 2.

但我們在這裡討論的是第 1a 階段和第 b 階段，以回答您剛才提出的問題，即在進入第 2 階段之前我們需要測量的正確的 PK/PD 和藥理行為是什麼。

Yale Jen, Laidlaw & Company.

耶魯仁萊德勞公司。

I have two here. The first one is that you mentioned a little bit earlier in terms of tariff situation at this point. Could you elaborate a little bit more in terms of whether you see something more negative or positive at this point? And then I have a follow-up question.

我這裡有兩個。第一個問題是，您剛才提到了目前的關稅狀況​​。您能否進一步詳細說明一下，目前認為情況是比較消極還是積極？然後我有一個後續問題。

Could you repeat the question? I'm not sure I got it.

你能重複一下這個問題嗎？我不確定我是否明白了。

The government tariff situation has --

政府關稅狀況--

Tariffs, yes tariffs. Yes. Thank you. I'll let Adam answer for our operations overseas and then I'll answer for R&D.

關稅，是的，關稅。是的。謝謝。我會讓亞當負責我們的海外業務，然後我負責研發。

Sure. Thanks, Elias. So for tariffs, Yale, we're obviously monitoring it. We're looking throughout our supply chain for mostly for BioReference. We do buy most of our products here from the U.S.

當然。謝謝，埃利亞斯。因此，對於關稅，耶魯大學，我們顯然正在監控它。我們在整個供應鏈中主要尋找 BioReference。我們的大部分產品確實是從美國購買的。

Some of it is manufactured internationally. So we're looking at all the different alternatives to minimize any impact. But as we sit here today, we think it's a manageable risk, but we'll continue to monitor it. As it relates to our pharmaceutical products, we do import both RAYALDEE and we know Pfizer sells NGENLA and GENOTROPIN, and they're manufactured in Ireland. So continue to monitor those.

其中一些是在國際上製造的。因此，我們正在研究各種不同的替代方案，以盡量減少影響。但今天我們坐在這裡，我們認為這是一個可控的風險，但我們會繼續監控它。就我們的藥品而言，我們確實進口 RAYALDEE，我們知道輝瑞銷售 NGENLA 和 GENOTROPIN，而且它們是在愛爾蘭生產的。因此請繼續監視這些。

Obviously, the US market or the cost of goods is a minor component of the total cost structure. So we wouldn't expect it to have a significant impact. And obviously, the hDH franchise is a global franchise. So it only impacts the US market.

顯然，美國市場或商品成本只是總成本結構的一小部分。所以我們預計它不會產生重大影響。顯然，hDH 特許經營是一個全球特許經營。所以它只影響美國市場。

And for R&D, we primarily depend on European and also Chinese CROs and CDMOs. That has been essentially a minor amount of services that we need to obtain outside of the U.S. And as far as we can tell, we don't see a significant impact on R&D operations from tariffs.

對於研發，我們主要依賴歐洲和中國的 CRO 和 CDMO。這基本上只是我們需要在美國境外獲得的一小部分服務。據我們所知，關稅不會對研發業務產生重大影響。

Okay. Great. And maybe a follow-up in terms of the [MASH] product -- MASH development, sorry. Do you anticipate this -- so the target for the earlier stage of NASH or much more the later stage in the fibrosis part of it, in the [phase?]

好的。偉大的。也許是 [MASH] 產品的後續行動——MASH 開發，抱歉。您是否預見了這一點？ NASH 早期階段的目標，還是纖維化部分的後期階段的目標，[階段？ ]

Right. That's a great question. So we're still thinking through it, obviously. We are inclined to really use the product where it's most needed, and that is F3 or F3 NASH or F4 early F4 NASH, pre-cirrhotic NASH at the beginning.

正確的。這是一個很好的問題。所以顯然我們仍在考慮這個問題。我們傾向於在最需要的地方真正使用該產品，那就是 F3 或 F3 NASH 或 F4 早期 F4 NASH，即初期的肝硬化前期 NASH。

We do not believe there's as much of a need for F2 and F3, early F3 because of the alternatives that you have on the market right now. So that's where we are focusing our efforts, but we haven't yet decided that.

我們認為，由於目前市場上已有替代品，因此對 F2、F3 和早期 F3 的需求並不大。這就是我們努力的重點，但我們還沒有做出決定。

Michael Petusky, Barrington Research.

巴林頓研究公司的麥可‧佩圖斯基（Michael Petusky）

Adam, could you repeat -- I'm sorry, I got a little garbled on my end, the revised guidance for BARDA revenue?

亞當，您能重複一遍嗎——抱歉，我有點搞錯了，BARDA 收入的修訂指南是什麼？

Yes. It's $38 million to $44 million, which is down from $40 million to $48 million.

是的。為 3800 萬美元至 4400 萬美元，低於 4000 萬美元至 4800 萬美元。

Okay. All right. And then on NGENLA and just the idea that, hey, we think this is a one-quarter issue. I mean, is that based on sort of the script data? Or is it based on any kind of conversations with Pfizer, at least preliminary conversations with Pfizer sort of suggesting that?

好的。好的。然後關於 NGENLA 以及這個想法，嘿，我們認為這是一個季度問題。我的意思是，這是基於腳本資料嗎？還是它是基於與輝瑞的任何對話，至少是與輝瑞的初步對話暗示了這一點？

Or can you just sort of, I guess, dig into that a little bit for me?

或者您能否為我稍微深入地探討一下這個問題？

Sure. So we talk to Pfizer at least once a quarter, just to get general updates. They haven't indicated that there were anything in our first quarter conversation. We haven't spoken with them since we've received these results. But we do look at the script data and the script data continues to indicate a growing franchise, so -- and no significant changes.

當然。因此，我們每季至少與輝瑞公司溝通一次，以獲取一般更新資訊。他們沒有表明我們第一季的談話中有任何進展。自從我們收到這些結果以來，我們還沒有與他們交談過。但我們確實查看了劇本數據，劇本數據繼續表明特許經營權正在增長，所以 - 並沒有發生重大變化。

So we're not sure -- certain if it was anything on a gross to net basis that impacted it or on the manufacturing side, if there were any charges that came through there that impacted the gross profit share. I'll note that last year, the first quarter was the low quarter of the year. And we would expect, as I guided, that this was a nonrecurring issue for us, and it will rebound to historical norms.

因此，我們不確定——不確定是否有任何因素對毛利與淨利產生了影響，或者在製造業方面，是否有任何費用影響了毛利潤份額。我要指出的是，去年第一季是全年業績較低的一個季度。正如我所引導的，我們預計這對我們來說不是一個經常性的問題，它將反彈至歷史正常水平。

Okay. All right. And then just on the Diagnostics business, if -- and I understand that the oncology will be sold, but that business -- if that asset had not been sold, would you have been able to get to sort of cash flow breakeven this year or not?

好的。好的。然後就診斷業務而言，如果——我知道腫瘤科業務將被出售，但是該業務——如果該資產沒有被出售，您今年是否能夠實現現金流收支平衡？

Yes. So we -- part of our plans, Mike, were -- we had a couple of different ones. One was to work to find a way to monetize it through a transaction like we entered into with Pfizer -- sorry, with LabCorp. The other was to continue to exit certain lines of testing and certain clients that have high demands for service that our scale just wouldn't allow us to reach. So we had fully expected to get there and certainly could.

是的。因此，麥克，我們的計劃有多個不同的版本。一是努力尋找方法，透過像我們與輝瑞（抱歉，是與 LabCorp）達成的交易來實現貨幣化。另一個是繼續退出某些測試線和某些對服務有很高要求的客戶，而我們的規模不允許我們滿足這些要求。所以我們完全期望能夠到達那裡，而且也一定能夠到達。

Thank you. This concludes our question-and-answer session. I would like to turn the conference back over to Dr. Phillip Frost, Chairman and Chief Executive Officer, for any closing remarks.

謝謝。我們的問答環節到此結束。我想將會議交還給董事長兼執行長菲利普·弗羅斯特博士，請他致閉幕詞。

I want to thank you all for your participation, for your good questions, and we look forward to talking to you again at the end of the next quarter. Thank you again.

我想感謝大家的參與和提出的好問題，我們期待在下個季度末再次與你們交談。再次感謝您。

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。