OPKO Health Inc (OPK) 2024 Q3 法說會逐字稿

Good day and welcome to the OPKO Health third-quarter of 2024 financial results conference call. (Operator Instructions).

大家好，歡迎參加 OPKO Health 2024 年第三季財務業績電話會議。（操作員指令）。

After today's presentation, there will be an opportunity to ask questions.

今天的演講結束後，將有機會提問。

(Operator Instructions).

（操作員指令）。

I would now like to turn the conference over to Yvonne Briggs. Please go ahead.

現在我想將會議交給伊馮娜·布里格斯。請繼續。

Thank you, operator and good afternoon. This is Yvonne Briggs with alliance advisors, investor relations. Thank you all for joining today's call to discuss OPKO Health's financial results for the third quarter of 2024.

謝謝接線員，下午好。我是聯盟顧問、投資者關係部負責人伊馮娜‧布里格斯 (Yvonne Briggs)。感謝大家參加今天的電話會議，討論 OPKO Health 2024 年第三季的財務表現。

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.

我想提醒大家，管理階層在本次電話會議上所作的任何陳述（歷史事實陳述除外）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 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, 2023, and in subsequently filed sec reports, this conference call contains time sensitive information that is accurate only as of the date of the live broadcast.

這些前瞻性陳述包括但不限於本公司向美國證券交易委員會提交的文件中所述的各種風險，包括截至 2023 年 12 月 31 日的 10-K 表格年度報告以及隨後向美國證券交易委員會提交的報告中，本次電話會議包含的時間敏感資訊僅在直播之日準確。

November 7, 2024 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.

2024 年 11 月 7 日，除非法律另有要求，否則 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召開日後事件或情況的義務。

Before we begin, let me review the format for today's call, Dr. Phillip Frost, Chairman and Chief Executive Officer will open the call, Dr. Elliot Zerhouni, Vice Chairman and President will then provide an overview of Bio Reference health as well as OPKO's pharmaceutical business. After that, Adam Logal OPKO's Chief Financial Officer will review the company's third quarter financial results and provide fourth quarter financial guidance and then we'll open up the call to questions.

在我們開始之前，讓我回顧一下今天電話會議的形式，董事長兼執行長 Phillip Frost 博士將主持會議，副董事長兼總裁 Elliot Zerhouni 博士將概述 Bio Reference health 以及 OPKO 的製藥業務。之後，OPKO 財務長 Adam Logal 將回顧該公司第三季度的財務業績並提供第四季度的財務指導，然後我們將開始問答環節。

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.

下午好，感謝您今天加入我們。

We had a good third quarter with positive developments in both our diagnostics and pharmaceutical segments.

我們的第三季表現良好，診斷和製藥領域均取得了積極的發展。

Significant progress has been made to put our reference on a clear path to profitability. After selling certain assets to LabCorp, we continue the development of the ModeX technology product portfolio. Pfizer has successfully launched Engine in all priority markets, and we continue to be enthusiastic about positive animal studies of our once weekly injectable dual GLP-1/glucagon Agoist program.

我們已取得重大進展，並已走上盈利的明確道路。在將部分資產出售給 LabCorp 後，我們繼續開發 ModeX 技術產品組合。輝瑞已經在所有優先市場成功推出了 Engine，我們繼續對每週注射一次的雙重 GLP-1/胰高血糖素 Agoist 計劃的積極動物研究充滿熱情。

Our collaboration with an Entera bio on an orally delivered once daily version of our Oxyntomodulin also shows great promise in animal studies.

我們與 Entera 生物公司合作研發的每日一次口服的胃泌酸調節素在動物研究中也展現出巨大的前景。

We bolstered our balance sheet with significant cash infusions to ensure adequate funding for our pharmaceutical pipeline and to return capital to our shareholders through a stock repurchase program.

我們透過大量現金注入來增強我們的資產負債表，以確保為我們的藥品管道提供充足的資金，並透過股票回購計畫向股東返還資本。

As we continue to execute our strategy, we expect these important catalysts to ultimately be reflected in a closer alignment of the value of our assets and our stock price are currently portfolio consists of a variety of segments that investors need to evaluate.

隨著我們繼續執行我們的策略，我們預計這些重要的催化劑最終將反映在我們的資產價值和股票價格的更緊密結合上，目前的投資組合由投資者需要評估的各種部分組成。

We plan to operate these segments to drive value for OPKO with additional partnerships, business development initiatives and asset sales. We're confident in our business and strategy and we'll consider expansion of our share buyback program as appropriate.

我們計劃透過增加合作夥伴關係、業務發展計劃和資產出售來營運這些部門，為 OPKO 創造價值。我們對我們的業務和策略充滿信心，我們將考慮適當擴大我們的股票回購計劃。

OPKO is structured around five key businesses by reference ModeX, our growth hormone franchise with Pfizer, our global health care business and our pipeline assets.

OPKO 圍繞著五大核心業務構建，包括 ModeX、我們與輝瑞的生長激素特許經營權、我們的全球醫療保健業務以及我們的管道資產。

We have the ability to explore partnerships and sales or business development activities with each in order to build value, unlock value and return capital to OPKO.

我們有能力與各方探索合作夥伴關係、銷售或業務發展活動，以創造價值、釋放價值並向 OPKO 回饋資本。

You've seen some evidence of this so far in 2024 and we hope to continue the process in 2025.

到目前為止，您已經在 2024 年看到了一些證據，我們希望在 2025 年繼續這項進程。

We look forward to keeping you apprised of our progress with that introduction. I'll turn the call over to Elias.

我們期待向您通報我們在這一介紹方面的進展。我會把電話轉給 Elias。

Well, thank you, Phil. And good afternoon, everyone I still mention OPKO completed the sale of BioReference health laboratory testing, businesses focused on clinical diagnostics and women's health nationwide, but excluding operations in New York and New Jersey, which we retain the sale was for $237.5 million. BioReference help will continue to offer specialty oncology and neurology, diagnostic services nationwide as well as maintain a comprehensive menu of core services in New York and New Jersey.

好吧，謝謝你，菲爾。大家下午好，我仍然要提到 OPKO 完成了 BioReference 健康實驗室測試的出售，該業務專注於全國範圍內的臨床診斷和婦女健康，但不包括紐約和新澤西的業務，我們保留的售價為 2.375 億美元。BioReference 將繼續在全國範圍內提供專業腫瘤學和神經病學、診斷服務，並在紐約和新澤西州維護全面的核心服務菜單。

This will allow us to streamline our overall infrastructure and reduce operating costs to better position the division for sustained growth and profitability, the assets we sold had annual revenue of about $100 million. Now net sales from the remaining operations continuing to Bio Russia's health exceeded $400 million in 2023 as an indication.

這將使我們能夠簡化整體基礎設施並降低營運成本，從而使部門更好地實現持續成長和獲利，我們出售的資產年收入約為 1 億美元。現在，Bio Russia 剩餘業務的淨銷售額預計將在 2023 年超過 4 億美元。

Our high specialty high value testing segments continue to perform well with oncology testing volume in the third quarter of this year was up 6.8% compared to the third quarter of 2023.

我們的高專業高價值檢測部門持續表現良好，今年第三季的腫瘤學檢測量與 2023 年第三季相比成長了 6.8%。

And this reflects both the depth and the innovation of our testing portfolio and expanded collaborations with large cancer centers and health systems.

這反映了我們的檢測組合的深度和創新性，以及與大型癌症中心和醫療系統的擴大合作。

Additionally, in Q3 BioReference received New York state approval for Onko HRD testing for homologous recombination deficiency in breast ovarian prostate and pancreatic cancers where PARP inhibitors like Lysa from Astrazeneca, for example, are a unique therapeutic option.

此外，BioReference 在第三季度獲得了紐約州的批准，可使用 Onko HRD 檢測來治療乳腺癌、卵巢癌、前列腺癌和胰腺癌中的同源重組缺陷，而阿斯特捷利康的 Lysa 等 PARP 抑制劑是一種獨特的治療選擇。

These tests are necessary to guide the patient for the best therapy. And so, this makes by reference one of the few labs to offer a full comprehensive tumor sequencing menu with our oncocyte advanced next gen sequencing testing.

這些測試對於指導患者採取最佳治療措施是必要的。因此，我們成為少數幾個透過我們的腫瘤細胞先進的下一代定序測試提供全面腫瘤測序菜單的實驗室之一。

Germline testing with Onko risk and now an HRD option in Onko HRD for patients with these common cancers. And this combined offering provides patients and clinicians with the most comprehensive view of the patient's cancer subtype and the therapeutic options to be considered by their treating physicians.

使用 Onko 風險進行種系檢測，現在 Onko HRD 為患有這些常見癌症的患者提供 HRD 選項。這種綜合服務為患者和臨床醫生提供了有關患者癌症亞型以及主治醫生考慮的治療方案的最全面的視圖。

As for our urology segment, the full case court test, which is an FDA approved blood biomarker test indicated for use in men aged 45 and above with elevated P SAS or at risk of prostate cancer and require prostate biopsy for confirmation.

至於我們的泌尿科部門，全案法庭測試是 FDA 批准的血液生物標記測試，適用於 45 歲及以上 P SAS 升高或有前列腺癌風險並需要前列腺活檢進行確認的男性。

Here to date. The four cores delivered a strong growth of 16% over the same period. In 2023 the four K score test provides an individual's probability score of finding aggressive prostate cancer defined as a Gleason score equal or greater than seven prior to a biopsy decision.

至今為止都在這裡。同期，四大核心均實現了16%的強勁成長。2023 年，四個 K 評分測試提供了個人發現侵襲性前列腺癌的機率評分，定義為活檢決定之前的格里森評分等於或大於 7。

And a recent publication in the European Association of Urology journal. Regarding a review of 49 clinical studies concluded that among eight different liquid biomarker tests for prostate cancer assessment, the highest diagnostic performances and ratio is the four case core test.

以及最近在歐洲泌尿外科協會雜誌上發表的一篇論文。對 49 項臨床研究的回顧得出結論，在八種用於評估前列腺癌的不同液體生物標記測試中，診斷性能和比率最高的是四種核心病例測試。

In the last decade, several European countries have initiated population based prostate cancer screening trials to evaluate whether a screening algorithm that included both PSA and biomarker tests can reduce over diagnosis of prostate cancer.

在過去十年中，一些歐洲國家已經啟動了基於人群的前列腺癌篩檢試驗，以評估包括 PSA 和生物標記測試的篩檢演算法是否可以減少前列腺癌的過度診斷。

And the four-case court test has been included in several of these mass screening trials and demonstrated the value of the four-case course test. The four K tested stratifying men with elevated PSA and the high probability of prostate cancer.

並且四案例法庭測試已被納入其中幾次大規模篩檢試驗，並證明了四案例課程測試的價值。四個 K 測試對 PSA 升高且患有前列腺癌機率高的男性進行分層。

No switching gears to our pharmaceutical segments. Our mono therapeutics programs are progressing nicely. A Tetra-specific antibody MDX 2001 initiated a phase one trial and is currently dosing patients. This open label trial at four sites is expected to enroll 45 patients with a variety of solid tumors including lung, breast prostate and pancreatic cancers.

我們不會改變製藥部門的模式。我們的單一療法課程進展順利。Tetra 特異性抗體 MDX 2001 已啟動第一階段試驗，目前正在給患者服用。這項在四個地點進行的開放標籤試驗預計將招募 45 名患有肺癌、乳腺癌、前列腺癌和胰腺癌等多種實體腫瘤的患者。

The phase one, a portion of the study is primarily designed to evaluate the safety and immunogenicity of ascending doses of MDX 2001 and to establish a biologically active dose in humans. Our other immunocologie programs, MBX 2003 are tetraspecific antibody for liquid tumors and autoimmune medications as well as MBX 2004 immune modulator Multispecific antibody are progressing to IDS and expected to enter the clinic.

第一階段研究的一部分主要旨在評估 MDX 2001 劑量增加的安全性和免疫原性，並確定人體內的生物活性劑量。我們的其他免疫學項目，MBX 2003是針對液體腫瘤和自體免疫藥物的四特異性抗體，以及MBX 2004免疫調節劑多特異性抗體正在進展到IDS並有望進入臨床。

Next year.

明年。

Of note, last month, we were awarded $51 million of additional funding under our existing VA contract to develop COVID Multispecific antibodies and to initiate an influenza program leveraging our MSTAR antibody platform.

值得注意的是，上個月，我們根據現有的 VA 合約獲得了 5,100 萬美元的額外資金，用於開發 COVID 多特異性抗體並利用我們的 MSTAR 抗體平台啟動流感計劃。

Approximately $35 million of these $51 million in additional funding is earmarked for the development of the second novel Multispecific antibody to SARS‑CoV‑2 COVID-2 from preclinical through phase one trials as well as preclinical work on the gene-based expression of Multispecific antibodies to SARS‑CoV‑2 including mRNA as well as DNA vectors.

在這 5,100 萬美元的額外資金中，約有 3,500 萬美元專門用於開發第二種新型 SARS-CoV-2 COVID-2 多特異性抗體，從臨床前到第一階段試驗，以及基於基因的 SARS-CoV-2 多特異性抗體表達的臨床前工作，包括 mRNA 和 DNA 載體。

In addition, Barta activated funding tolling $16 million from our current contract to begin development of influenza multi specific antibodies with potential gene and protein delivery modalities. So collectively, this non diluted funding brings the total committed support from Barda actually at $110 million with a potential for a total of $203 million in total.

此外，Barta 還從我們目前的合約中撥出 1,600 萬美元的資金，開始開發具有潛在基因和蛋白質遞送方式的流感多特異性抗體。因此，總的來說，這筆非稀釋資金使 Barda 承諾的支持總額實際上達到了 1.1 億美元，總額可能達到 2.03 億美元。

If all options and milestones are executed, this additional funding if granted will be used to accelerate the COVID program, the flu program and target other biodefense threats as well as develop a platform with gene based delivery methods for use against future pandemics.

如果所有選項和里程碑都得到執行，這筆額外資金（如果獲得批准）將用於加速 COVID 計劃、流感計劃和針對其他生物防禦威脅，以及開發一個基於基因的遞送方法的平台，以用於對抗未來的大流行。

In addition, our collaboration with Mark for Epstein-Barr Virus, multivalent nanoparticle vaccine is on track to enter the clinic soon. Preclinical work is being performed by ModeX in collaboration with Merck and has been funded by Merck. After phase one, human studies begin, Merck will assume all development activities through to commercialization.

此外，我們與馬克合作研發的愛潑斯坦-巴爾病毒的多價奈米顆粒疫苗也即將進入臨床。臨床前工作由 ModeX 與默克公司合作進行，並由默克公司資助。第一階段人體研究開始後，默克公司將承擔所有開發活動直到商業化。

I'd like to recall that we received an upfront payment of $50 million and are eligible for milestone payments associated with progress in the development and commercialization of MDX-2201 or the EBV virus vaccine. And these milestones add up to about $872.5 million as well as royalties on global sales.

我想回顧一下，我們收到了 5000 萬美元的預付款，並且有資格獲得與 MDX-2201 或 EBV 病毒疫苗的開發和商業化進展相關的里程碑付款。這些里程碑加上全球銷售特許權使用費總計約 8.725 億美元。

Now, Pfizer's launch of our pediatric long-acting growth hormone drug agenda continues to gain share as patients shift from the daily product to this more convenient once weekly drug. Now OPKO’s is also entitled to an additional $100 million in potential milestone payments related to additional pediatric and adult educations. And that is unaffected by the note purchase agreement with healthcare royalty partners.

現在，隨著患者從每日服用的產品轉向這種更方便的每週服用一次的藥物，輝瑞推出的兒科長效生長激素藥物計劃的市場份額繼續增加。現在，OPKO 還可獲得與額外的兒科和成人教育相關的額外 1 億美元潛在里程碑付款。這不受與醫療保健特許權使用費合作夥伴簽訂的票據購買協議的影響。

Now, something very interesting has happened and that is that we have continued to advance the development of our long acting oxy modular analog in both subcutaneous and oral formulations.

現在，發生了一件非常有趣的事情，那就是我們繼續推進皮下和口服製劑中長效氧模組類似物的開發。

As you know, oxygenic analog are the basis of the peptides that are being used today for diabetic patients as well as for weight loss.

眾所周知，氧類似物是目前用於治療糖尿病患者以及減肥的勝肽的基礎。

Now, the polyethylene glycol (PEG) linked peptide, which we had studied and progressed to phase two clinical trials. As we reviewed the data, we essentially suspended the trials after the completion did not proceed because of those limiting formulation, but the same key peptide was then redesigned as an isolated compound. And it has been confirmed in in vitro acids and animal disease models to be a strong candidate for once weekly subcutaneous administration.

現在，我們對聚乙二醇（PEG）連接勝肽的研究已經進展到第二階段臨床試驗。當我們審查數據時，由於這些限制性配方，我們基本上在完成後暫停了試驗，但相同的關鍵勝肽隨後被重新設計為分離化合物。並且已經在體外酸和動物疾病模型中被證實是每週一次皮下給藥的有力候選藥物。

And so, in collaboration with entera bio, we recently announced results from our ongoing collaborative research, combining our novel isolated compound and enter and terrace proprietary and tap technology to see if we could deliver our compound orally. And the program is focused on developing the very first oral dual agonist, GLP-1/glucagon peptide.

因此，我們與 entera bio 合作，最近公佈了我們正在進行的合作研究的結果，將我們的新型分離化合物與 enter and terrace 專有和 tap 技術相結合，看看我們是否可以透過口服的方式遞送我們的化合物。此計畫專注於開發第一個口服雙重激動劑 GLP-1/胰高血糖素勝肽。

And this could be a potential once daily treatment for patients with obesity or metabolic disorders including MS, the vivo studies in rodents and pig models showed that a single oral dose administration resulted in a desirable PK profile and by availability that would support a once daily oral treatment regimen. In parallel, we're going to continue to develop our injectable once a week formulation and trials for the GLP-1/glucagon peptide.

這可能是針對肥胖症或代謝紊亂（包括 MS）患者的潛在每日一次治療方法，在囓齒動物和豬模型中進行的體內研究表明，單次口服劑量給藥可產生理想的 PK 特徵，並且其可用性可支持每日一次的口服治療方案。同時，我們將繼續開發每週注射一次的配方，並進行 GLP-1/胰高血糖素勝肽的試驗。

We have recently generated, we look forward to presenting these findings at an upcoming clinical conference. So, in summary, we are encouraged by the progress made in both our diagnostic and biopharmaceutical business segments.

我們最近產生了這些發現，我們期待在即將舉行的臨床會議上展示這些發現。總而言之，我們對診斷和生物製藥業務部門的進展感到鼓舞。

We're pleased that our internal innovation has attracted significant partnerships to date while our balance sheet has been bolstered to adequately fund our operations and our growing pipeline of first in class products. And so, we remain confident in our business strategy and our ability and capacity to drive progress with that

我們很高興，迄今為止，我們的內部創新已經吸引了重要的合作夥伴，同時我們的資產負債表得到了增強，足以為我們的營運和不斷增長的一流產品線提供足夠的資金。因此，我們對我們的業務策略以及推動這項策略進步的能力充滿信心。

. I'll now turn the call over to Adam Logal to discuss our third quarter financial results. Adam.

。現在我將把電話轉給亞當洛加爾 (Adam Logal) 討論我們的第三季財務業績。亞當。

Thank you, Elias, as Phil and Elias have discussed the third quarter of 2024 was transformational for our business and our balance sheet, we ended September with over $400 million in cash and cash equivalents, which don't include 2 $23.7 million held in escrow related to our Labcorp transaction or restricted stock of $20 million.

謝謝你，埃利亞斯，正如菲爾和埃利亞斯所討論的那樣，2024 年第三季度對我們的業務和資產負債表具有變革性，截至 9 月底，我們擁有超過 4 億美元的現金和現金等價物，其中不包括與我們的 Labcorp 交易相關的 2 2,370 萬美元的託管資金或 2,000 萬美元的限制性股票。

We repurchased and retired 14.9 million shares of our common stock for $23.8 million through September 30. And through yesterday, we repurchased and retired a total of 24 million shares for $37.3 million under our $100 million share repurchase program.

截至 9 月 30 日，我們以 2,380 萬美元回購並註銷了 1,490 萬股普通股。截至昨天，我們根據 1 億美元的股票回購計畫共回購和註銷了 2,400 萬股股票，價值為 3,730 萬美元。

This does not include the 55 million shares that we repurchased earlier this year, bringing our total repurchases year-to-date to 79 million shares or approximately 10% of shares outstanding. As of January 1.

這還不包括我們今年稍早回購的 5,500 萬股，因此今年迄今我們的回購總額已達 7,900 萬股，約佔已發行股票的 10%。截至 1 月 1 日。

Further, we closed our asset-based lending facility with J.P. Morgan with the cash inflows from our Labcorp and healthcare royalty transactions.

此外，我們還利用 Labcorp 和醫療保健特許權使用費交易的現金流入，與摩根大通結束了資產抵押貸款業務。

We have a significant cash balance, and we will be disciplined in what we invest in including our highest priority R&D programs. We will also continue to fund our opportunistic equity, and convertible note repurchases as a demonstration of our commitment to enhancing shareholder value.

我們擁有大量現金餘額，我們將嚴格控制投資，包括我們最優先的研發項目。我們也將繼續為我們的機會股權和可轉換票據回購提供資金，以表明我們致力於提高股東價值的承諾。

With that, let's review our financial results for the third quarter.

讓我們回顧一下第三季的財務表現。

Starting with our diagnostic segment revenue was $121.3 million for the third quarter of 2024 compared with $131.7 million for the 2023 period.

首先，我們的診斷部門 2024 年第三季的營收為 1.213 億美元，而 2023 年同期的營收為 1.317 億美元。

This decrease was primarily the result of lower testing volumes including the impact of the Labcorp transaction that occurred mid quarter during the quarter as well as two hurricanes impacting the impacting the southeast during the third quarter of 2024 costs and expenses totaled $184.2 million compared with $160.8 million for the comparable quarter of 2023.

這一下降主要是由於測試量下降，包括本季中期發生的 La​​bcorp 交易的影響以及 2024 年第三季影響東南部的兩次颶風，成本和費用總計 1.842 億美元，而 2023 年同期為 1.608 億美元。

Importantly, costs and expenses included approximately $30 million of nonrecurring costs and expenses for severance facility closure costs and contractual volume shortfalls all incurred as expected as we rely on our business to ensure sustainable growth and profitability. After the Labcorp transaction closing during the third quarter of 2024 we also recorded a gain of $121.5 million on the transaction with labcorp which resulted in operating income of $58.5 million compared to an operating loss of $29.1 million for the 2023 quarter depreciation, the amortization expense for the diagnostic segment with 6.1 and $8.4 million for the 2024 and 2023 periods respectively.

重要的是，成本和費用包括約 3000 萬美元的非經常性成本和費用，用於遣散設施關閉成本和合約數量短缺，所有這些都是預期發生的，因為我們依靠我們的業務來確保可持續增長和盈利能力。在 2024 年第三季 Labcorp 交易結束後，我們還在與 labcorp 的交易中獲得了 1.215 億美元的收益，這導致了 5850 萬美元的營業收入，而 2023 年季度折舊的營業虧損為 2910 萬美元，診斷部門的攤銷費用分別為 2024 年的 2024 年和 60 萬美元。

As we have discussed on previous calls, the transaction was a major step for us to return to profitability and the restructuring activities. This transaction allowed and we initiated this quarter put us in a strong position to have the business operating at a breakeven run rate by the end of this year and operating cash flow positive and profitability in 2025.

正如我們在之前的電話會議上討論的那樣，此次交易是我們恢復盈利能力和重組活動的重要一步。這項交易使我們在本季度啟動並處於有利地位，使我們的業務在今年年底前實現盈虧平衡，並在 2025 年實現經營現金流為正並盈利。

Moving to our pharmaceutical segment revenue was $52.4 million for the third quarter of 2024. Compared with $46.9 million. For the comparable period of 2023 revenue from products including our international pharmaceutical businesses was $39.1 million compared to $40.7 million. For the comparable period of 2023.

我們的製藥部門 2024 年第三季的營收為 5,240 萬美元。相比之下，這一數字為 4,690 萬美元。2023 年同期（包括我們的國際製藥業務）產品收入為 3,910 萬美元，去年同期為 4,070 萬美元。與 2023 年同期相比。

Despite the challenging foreign currency environment, the profitability profile of this business continues to improve above our expectations.

儘管外匯環境充滿挑戰，但該業務的獲利狀況仍持續改善，超出我們的預期。

Product revenue includes revenue from royalty of $5.8 million which was lower than 2023 $7.3 million reflecting an increase in the cost of our copay assistance programs and a slight decrease in the number of bottles shipped revenue from the transfer of IP was $13.2 million for the third quarter of 2024. Compared to $6.2 million for the 2023 quarter. Our gross profit share from Pfizer was $7.4 million during the third quarter of 2024 compared to $4.9 million for the 2023 period.

產品收入包括特許權使用費收入 580 萬美元，低於 2023 年的 730 萬美元，這反映了我們的共付額援助計劃成本的增加以及運輸瓶子數量的略有減少，2024 年第三季度來自 IP 轉讓的收入為 1,320 萬美元。相比之下，2023 年季度為 620 萬美元。2024 年第三季度，我們從輝瑞獲得的毛利為 740 萬美元，而 2023 年同期為 490 萬美元。

In addition, the third quarter of 2024 includes $5.5 million in R&D. Funding related to our BARDA Agreement costs and expenses for our pharmaceutical segment were $84.6 million for the third quarter of 2024. Compared to $72.3 million for the 2023 period.

此外，2024 年第三季還包括 550 萬美元的研發費用。2024 年第三季度，我們製藥部門的 BARDA 協議成本和費用相關資金為 8,460 萬美元。相比之下，2023 年這一數字為 7,230 萬美元。

Research and development expenses were $28.2 million compared to $18.9 million a year ago.

研發費用為 2,820 萬美元，去年同期為 1,890 萬美元。

R&D expense increased as a result of our activities for our ModeX development programs including the recently commenced phase one clinical trial for our Immuno-oncology program, as well as our bar A supportive activities.

研發費用增加是由於我們的 ModeX 開發計畫活動，包括最近開始的免疫腫瘤學計畫第一階段臨床試驗，以及我們的 A 類支持活動。

The resulting operating loss for the quarter ended September 30, 2024 was $32.2 million compared to an operating loss of $25.4 million. For the third quarter of 2023 depreciation and amortization expense for the quarter increased slightly to 18 point million $18 million from $17.8 million for the 2023 quarter.

截至 2024 年 9 月 30 日的季度的營運虧損為 3,220 萬美元，而去年同期的經營虧損為 2,540 萬美元。2023 年第三季的折舊和攤提費用從 2023 年季度的 1,780 萬美元小幅增加至 1,800 萬美元。

Turning to our consolidated financial results for the third quarter of 2024 we reported net income of $24.9 million or 3¢ per diluted share compared with a net loss of $84.5 million or 11¢ per share for the 2023 period.

談到我們 2024 年第三季的綜合財務業績，我們報告的淨收入為 2,490 萬美元或每股攤薄收益 3 美分，而 2023 年同期的淨虧損為 8,450 萬美元或每股 11 美分。

Net income for the third quarter of 2024 included a noncash unrealized gain on our investment of GDX of $45.9 million compared to a noncash unrealized loss of $8.3 million for the 2023 period.

2024 年第三季的淨收入包括我們對 GDX 投資的非現金未實現收益 4,590 萬美元，而 2023 年同期的非現金未實現損失為 830 萬美元。

As we look ahead, we are providing financial guidance with the following assumptions.

展望未來，我們根據以下假設提供財務指導。

Pharmaceutical segment, we expect Pfizer to continue to grow sales of agenda and realize the benefits of the expanded gross margin due to the scale up of its manufacturing processes.

在製藥領域，我們預計輝瑞將繼續增加藥品銷售額，並透過擴大其製造流程來實現毛利率的提高。

We assume a stable foreign currency exchange rate for ex us, pharmaceutical businesses and R&D expenses for the fourth quarter of 2024 will reflect higher activities related to our ModeX programs including C MC efforts and progress with our BTA Agreements for our diagnostic segment.

我們假設，2024 年第四季度美國以外地區的製藥業務和研發費用的穩定外匯匯率將反映與我們的 ModeX 計劃相關的更多活動，包括 C MC 工作以及我們診斷部門的 BTA 協議的進展。

We are continuing our multi year multi phase program to improve profitability. This program is focused on operational efficiencies and the reduction of fixed infrastructure costs and is expected to deliver annualized savings of approximately $25 million by the end of 2024. Some of which we began realizing in the third quarter and will continue throughout the fourth quarter.

我們將繼續實施多年多階段計劃以提高盈利能力。該計劃專注於提高營運效率和降低固定基礎設施成本，預計到 2024 年底將實現每年約 2,500 萬美元的節省。其中一些我們在第三季開始實現，並將持續整個第四季。

We expect an additional $14 million of non-recurring costs in the fourth quarter, primarily including severance and facility closure costs to be paid out through 2028.

我們預計第四季將額外產生 1,400 萬美元的非經常性成本，主要包括到 2028 年支付的遣散費和設施關閉費用。

In addition, we have taken action and are seeing the benefits from our revenue cycle management programs including implementing price increases that were effective in the third quarter for certain testing modalities including our oncology offerings. These actions are expected to result in an overall increase in annual revenue of approximately 8 to $10 million for the full year of 2025.

此外，我們已經採取了行動，並從我們的收入週期管理計劃中看到了好處，包括從第三季開始對某些測試方式（包括我們的腫瘤學產品）實施價格上漲。這些舉措預計將使 2025 年全年年收入總體增加約 800 萬至 1,000 萬美元。

We have established gross margin thresholds and targets for our remaining business to be above 27% and expect a positive cash flow for the full year 2025 and and have established an additional cost initiative targeting an additional $20 million of annualized cost savings.

我們已經為剩餘業務設定了毛利率門檻和目標，使其達到 27% 以上，並預計 2025 年全年現金流為正，同時還制定了額外的成本計劃，目標是額外實現 2000 萬美元的年度成本節約。

We look forward to providing further details and guidance during our fourth quarter call as a result, we expect the following for the fourth quarter of 2024 total revenues between 155 and $160 million with revenue from services between 95 and $98 million revenue from product sales between 41 and $44 million and other revenue between 13 and $18 million. Inclusive of the Pfizer gross profit share estimates between eight and $10 million as well as barter revenue of 5 to $8 million.

我們期待在第四季度電話會議中提供進一步的細節和指導，因此，我們預計 2024 年第四季的總收入在 1.55 億美元至 1.6 億美元之間，其中服務收入在 9500 萬美元至 9800 萬美元之間，產品銷售收入在 4100 萬美元至 4400 萬美元之間，其他收入在 180 萬美元之間。其中包括輝瑞的毛利份額估計在 800 萬至 1,000 萬美元之間，以及以物易物收入 500 萬至 800 萬美元。

We expect fourth quarter costs and expenses to be between 202 $110 million excluding the non-recurring expenses related to our restructuring of Bioreference R&D is expected to be between 28 and $34 million depending on the timing of certain activities for ModeX programs with 5 to $8 million being offset by part of funding.

我們預計第四季度的成本和費用將在 202 億美元之間，不包括與我們對 Bioreference 研發進行重組相關的非經常性費用，預計在 2800 萬至 3400 萬美元之間，具體取決於 ModeX 計劃某些活動的時間表，其中 500 萬至 800 萬美元將由部分資金抵消。

We finally expect depreciation and amortization expense to be between 22 and $23 million.

我們最終預計折舊和攤銷費用將在 2,200 萬至 2,300 萬美元之間。

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

我們的準備好的發言到此結束，謝謝各位接線生的注意。讓我們開始提問。

We will now begin the question-and-answer session to ask a question. (Operator Instructions).

我們現在開始問答環節來問一個問題。（操作員指令）。

Maury Raycroft , Jefferies'. Go ahead, please.

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

Hi, congrats on the progress and thank you for taking my questions. Maybe starting off just wondering what the next steps are for the modula analog 8,806.

你好，恭喜你取得的進展，謝謝你回答我的問題。也許一開始只是想了解模組化模擬 8,806 的下一步是什麼。

Now that you have the preclinical data for the subcutaneous form and the oral form as well, does (inaudible) plan to advance this into a phase one study in, in 2025?

現在您已經掌握了皮下形式和口服形式的臨床前數據，（聽不清楚）是否計劃在 2025 年將其推進到第一階段的研究？

And also, you said you will advance the SubQ form in parallel with the oral drug. Is this just for getting PK data or for keeping options open? Maybe talk more about the strategy between the oral and the SubQ version.

而您也說，您將與口服藥物同時推進 SubQ 劑型。這只是為了獲取 PK 數據還是為了保持選項開放？也許多談談口語版本和 SubQ 版本之間的策略。

That's a good question, Maury. Thank you. So yes, we're going to continue the development in parallel of the oral with Anter Bio as a collaborator and using the technology, we have early results that say two things, one is feasible and two is comparable to other peptides on the market in oral forms.

這個問題問得很好，莫里。謝謝。所以是的，我們將繼續與 Anter Bio 合作開發口服藥物，並利用該技術，我們獲得的早期結果表明兩件事，一是可行的，二是可與市場上口服的其他肽相媲美。

And so, we can be competitive there in terms of the injectable form. We just have to advance the preclinical work. We've done a lot of work on this molecule before even reaching a phase two with a different composition of matter.

因此，我們在註射劑型方面具有競爭力。我們只需推進臨床前工作。在進入物質組成不同的第二階段之前，我們已經對這種分子做了大量研究。

We think this one is much, much better because it allows you to do once a week injection and lower doses. So based on our experience, what we need to understand here is that this dual-agonist GLP-1/glucagon is different from most of the other peptides that are on the market today. There is one from boring (Inaudiable) that is comparable in at least composition of the peptides.

我們認為這個方法更好，因為它允許您每週注射一次並降低劑量。因此，根據我們的經驗，我們需要了解的是，這種雙重激動劑 GLP-1/胰高血糖素與目前市場上的大多數其他勝肽不同。有一個來自無聊的（聽不清楚）至少在勝肽的組成上是可比的。

And so, we need to advance that to the point where we can make a decision as to whether or not we have what we need to go to phase one.

因此，我們需要推進這項進程，以便能夠決定我們是否具備進入第一階段所需的條件。

So, we're in the preclinical phase, it has attracted interest, we're talking to other parties that may have an interest in partnering with us and the work is ongoing. Maur, so I can't make any more statements in that, but we're active in it. We're actively pursuing it.

因此，我們處於臨床前階段，它已經引起了人們的興趣，我們正在與可能有興趣與我們合作的其他方進行交談，而這項工作正在進行中。莫爾，我不能就此發表更多聲明，但我們對此非常積極。我們正在積極追求這一目標。

Got it understood. Okay. And then for the MDX 2001 study that's ongoing, do you anticipate, you could report a data update from that first half 25.

明白了。好的。那麼，對於正在進行的 MDX 2001 研究，您是否預計可以報告上半年 25 日的數據更新。

And I know this is an early study, but can you talk about expectations for what you could show in initial data and how this will influence next steps and continue the investment in the program?

我知道這是一項早期研究，但您能否談談對初始數據的期望，以及這將如何影響後續步驟並繼續對該計劃的投資？

So just so you know, there are two phases. The first one is basically escalation of the dose to a range where we think there will be an efficacy. So we have six doses that FDA allowed us to do. Those are done one patient at a time and you have to wait a month to see if there's no side effect.

你知道嗎，有兩個階段。第一個基本上是將劑量增加到我們認為有效的範圍。因此，FDA 允許我們注射六劑。這些治療每次只對一名患者進行，並且必須等待一個月才能看到是否有副作用。

Once that's done, we'll go to cohorts where we have three patients at a time in different cancers. And then we will be able to see if we have a, a response at this time. Now, for the first six, it probably will take another six months to get a read about whether or not we have a good safety profile is tolerable. And also finding out if you don't have antibody drug antibodies, anti drug antibodies.

一旦完成，我們將進入分組治療，每次治療三名患有不同癌症的患者。然後我們就能知道此時是否有回應。現在，對於前六個月來說，可能還需要六個月的時間才能知道我們的良好安全性是否可接受。並且也要查明您是否沒有抗體藥物抗體、抗藥物抗體。

So think of it in two ways. First is the first visibility toxicology phase, which we'll be reading out in the first half of 2025. More like towards the end of the first half, the second one is a much longer phase where we're going to test real doses that we believe are going to be effective in a basket trial of about 40 patients. And then that will take a while to read probably towards the middle of 26.

所以請從兩方面來思考。首先是第一個可見性毒理學階段，我們將在 2025 年上半年讀出。更像是在上半場的末尾，下半場是一個更長的階段，我們將在約 40 名患者的籃子試驗中測試我們認為有效的真實劑量。然後讀取可能需要一段時間，大概在 26 的中間。

We hope.

我們希望。

Got it. Okay. That's helpful. Thanks for taking my questions. I'll hop back in the queue.

知道了。好的。這很有幫助。感謝您回答我的問題。我將重新回到隊列中。

Jeff Cohen , Ladenburg Thalmann and company. Go ahead, please.

傑夫·科恩 (Jeff Cohen)、拉登堡·塔爾曼 (Ladenburg Thalmann) 和公司。請說。

Hi, thank you for taking our questions. This is Destiny on for Jeff. I wanted to start with the 2201 asset. You said you're moving it towards the clinic.

您好，感謝您回答我們的問題。對傑夫來說這就是命運。我想從 2201 資產開始。您說您要將其移向診所。

And at that point, I know that mark is going to take over for the the associated cost. So I'm wondering who is making that decision since you're both kind of jointly progressing this forward, right?

到那時，我知道馬克將接管相關費用。所以我想知道，既然你們都在共同推動這項進程，那麼誰來做這個決定呢？

We have a joint program basically, we've, you know, Merck is the sponsor. So, Merck will make the decision. We obviously have participated all the way through this phase here to the you know the entry into the clinic. But that decision is their decision, not our decision, but they have everything they need at this point to actually make that decision.

我們基本上有一個聯合項目，你知道，默克是贊助商。因此，默克公司將做出決定。顯然，我們一直參與這個階段，直到進入診所。但這個決定是他們的決定，不是我們的決定，但他們現在已經擁有做出這個決定所需的一切。

Okay. So, there's nothing outstanding that really is stopping them from moving forward. It's, it's more of a theming. Am I understanding correctly?

好的。所以，並沒有什麼突出的事情能夠真正阻止他們前進。這更像是一種主題。我的理解正確嗎？

Yes, you are. There's nothing in front of us. That's an obstacle at this point except them making a decision.

是的，你是。我們面前什麼都沒有。除非他們做出決定，否則這就是目前的一個障礙。

Okay. Perfect. And I want to quickly touch on BioReference. Congratulations on having that closed. I'm wondering if your profitability comments are kind of contingent on the investment that you have to make, I guess.

好的。完美的。我想快速談談 BioReference。恭喜您已結束此事。我想知道您的盈利能力評論是否取決於您必須進行的投資。

In other words, do you need to invest more into this business in order to reach those profitability goals or as it currently stands, trimming some more of the fat will be.

換句話說，您是否需要對這項業務進行更多投資才能達到這些獲利目標，或者就目前情況而言，是否需要削減一些成本。

Sufficient?

充足的？

I want to answer that.

我想回答這個問題。

Sure. So, Destiny, the costs that we're incurring those nonrecurring costs are the key for us to be able to get the business profitable. There's not significant investments that we need to make back into the business. There's not an expansion of the sales force or new product offerings or anything like that.

當然。所以，Destiny，我們承擔的那些非經常性成本是我們實現業務獲利的關鍵。我們不需要對該業務進行大量投資。銷售團隊沒有擴大，新產品也沒有推出之類的。

It is, simply just now that we've closed the transaction with Labcorp, giving us the ability to reduce our infrastructure size and an existing footprint to get us to those profitability numbers. So we're, you know, I'll call it weeks away from that point.

是的，剛才我們完成了與 Labcorp 的交易，這使我們能夠縮小基礎設施規模和現有足跡，以實現這些獲利數字。所以，你知道，我認為距離那個點還有幾週的時間。

Remember that we closed multiple laboratories and facilities from California all the way to Florida as part of the process. So we think we can, definitely improve profitability by focusing also in the New York, New Jersey area where we have the majority of our resources.

請記住，作為這一過程的一部分，我們關閉了從加利福尼亞州到佛羅裡達州的多個實驗室和設施。因此我們認為，透過集中關注我們大部分資源所在的紐約和新澤西地區，我們肯定能夠提高盈利能力。

And I think focusing there we believe will provide both efficiencies because we have right sized the lab for that market but also opportunities for growth.

我認為，專注於此不僅能提高效率，因為我們已經為該市場調整了適當規模的實驗室，而且還能提供成長機會。

Okay. Got it. I think that does it for me. You addressed everything else in your prepared remarks. So, I'll jump back in queue. Thank you.

好的。知道了。我認為這對我來說是有效的。您在準備好的發言中已經談到了其他所有問題。因此，我將重新回到隊列中。謝謝。

The next question comes from Yi Chen of HC Wainwright and company. Go ahead please.

下一個問題來自 HC Wainwright 公司的 Yi Chen。請繼續。

Thank you for taking my questions.

感謝您回答我的問題。

So, could you comment for OPK-88006, the glucagon peptide, do you? I mean, how much our performance in terms of ethics do you expect it to show compared to existing marketed GLP-1 drugs on the market? And also, between weekly SubQ version and also the daily oral version.

那麼，您能對胰高血糖素勝肽 OPK-88006 發表一些評論嗎？我的意思是，與市場上現有的 GLP-1 藥物相比，您期望我們在道德方面的表現如何？此外，每週 SubQ 版本與每日口服版本之間也有區別。

Which one do you think could potentially have better market adoption and the reasons for that? Thank you.

您認為哪一個可能獲得更好的市場認可，原因是什麼？謝謝。

Well, thank you for the question. So, when you look at the market, the way it has evolved, I think it really depends on three factors. One is obviously the composition of the peptide, you know, as compared to semaglutide or the or the boring compounds. And they all have differences and both of the old forms, and the injectable forms will have a place.

嗯，謝謝你的提問。因此，當你觀察市場及其發展方式時，我認為這實際上取決於三個因素。一個顯然​​是勝肽的組成，與司美魯肽或無聊的化合物相比。它們都有差異，舊形式和注射形式均有其一席之地。

We think simply because there's no other oral, there's only one oral semaglutide. And I think you will have actually phases of the therapy of these patients where oral forms will be necessary. You know, once you've done, once you've gone through maybe an injectable form, control the way then to sustain that over time, it might be better to go to an oral form.

我們認為只是因為沒有其他口服藥物，所以只有一種口服索馬魯肽。我認為，這些患者的治療實際上將經歷需要口服藥物治療的階段。您知道，一旦您完成了治療，一旦您嘗試了注射劑型，控制治療方式然後維持一段時間，最好採用口服劑型。

But that will all depend on the clinical performance of the molecules in terms of side effect and weight loss and and the necessary observation that you have to make. If you noticed, we said that you know this the peptide, this dual-agonist may have a greater role for patients who have liver disease. Nash, you know, they have to hepatitis. And then you know, the idea here is to really provide a continuum of care for the patients who will benefit from a glucagon addition. Remember the got one receptors don't exist in the liver but glucagon receptors do.

但這一切都取決於分子在副作用和減肥方面的臨床表現以及您必須進行的必要觀察。如果你注意到，我們說你知道這種勝肽，這種雙重激動劑可能對患有肝病的患者有更大的作用。納什，你知道，他們得了肝炎。然後你知道，這裡的想法是真正為那些將從胰高血糖素添加中受益的患者提供持續的護理。請記住，肝臟中不存在升糖素受體，但存在升糖素受體。

So you have, we hope a biological action that will be differentiated from the other ones. And there will be a class of patients, especially those who have evidence of liver malfunction that would be more appropriate for these new peptides. This is all speculation. We'll have to prove it. We're doing that.

所以，我們希望有一種生物作用能夠與其他生物作用有所區別。有一類病人，特別是那些有肝功能障礙跡象的病人，更適合使用這些新型勝肽。這全都是猜測。我們必須證明這一點。我們正在這麼做。

Now, in terms of safety, do you think it could potentially have a better safety profile compared to the semaglutide or to ZTT?

現在，就安全性而言，您是否認為與索馬魯肽或 ZTT 相比，它可能具有更好的安全性？

I mean, definitely the oral forms certainly will have that ability because you're giving an oral daily dose. And we know that these side effects that we see nausea, vomiting, diarrhea are related to what we call the maximum rise of the peptide in the blood. And so, because you're giving an oral form, which is much less than what you give every week.

我的意思是，口服劑型絕對有這種能力，因為你每天都會服用口服劑量。我們知道，噁心、嘔吐、腹瀉等副作用與我們所說的血液中勝肽的最大升高有關。因此，由於您提供的是口頭形式，因此這比您每週提供的要少得多。

In terms of the dose received by the patient, you would think that the oral form would be less, less prone to the side effects or the side effects. Now, the other one, I would not be able to speculate because there's no evidence one way or the other that will be added more or less than what is in the market today on the once a week injectable.

就患者接受的劑量而言，您可能會認為口服形式不太容易產生副作用或副作用。現在，對於另一種藥物，我無法進行推測，因為沒有任何證據表明這種每週注射一次的藥物添加量會比目前市面上的藥物添加量多或少。

Okay. Thank you.

好的。謝謝。

Edward Tenthoff , Piper Sandler. Go ahead, please.

愛德華·坦托夫，派珀·桑德勒。請說。

Great. Thank you for taking my question and congrats on all the progress, all these moving parts to strengthen the balance sheet and finance the company going forward.

偉大的。感謝您回答我的問題，並祝賀所有進展，所有這些活動都是為了加強資產負債表並為公司未來的發展提供資金。

My questions really had to do with the mode X cancer efforts and I'm wondering what we should be expecting in terms of data releases next year. You know, would this be more likely at a medical meeting.

我的問題確實與 X 模式癌症治療工作有關，我想知道我們應該對明年的數據發布抱持怎樣的期望。你知道，這在醫學會議上更有可能發生嗎？

Is it something you'll update kind of as you get things interesting? And what, what should we really be expecting in terms of escalation and then ultimately guidance with respect to expansion cohorts where you might develop the asset things.

當你發現一些有趣的事情時，你會更新它嗎？那麼，在升級方面我們真正應該期待什麼，以及最終在擴展隊列方面可能開發資產的指導。

Yeah, thanks. We want to obviously inform as we have data coming out. The first is that the mid, mid, mid, mid, mid 2025 when we will have the first readout in the in humans of the performance of this platform in terms of its ability to be tolerated, any side effects or antibody anti-drug antibodies.

是的，謝謝。我們希望在有數據發佈時就能及時告知。第一個是到 2025 年中期，我們將首次讀取該平台在人體中的表現，包括其耐受性、任何副作用或抗體抗藥性抗體。

Okay. So that's the first data because at the end of the day, you know, we have to really show that this platform is well tolerated in cancer patients, then comes the second phase for MDX 2001, which is the one that is in the clinic of do we see efficacy?

好的。所以這是第一批數據，因為到最後，你知道，我們必須真正證明這個平台對癌症患者有良好的耐受性，然後才是 MDX 2001 的第二階段，也就是在臨床上我們是否能看到療效？

And in what tumor? So that will be basically middle of '26 I would think. And then at that time, depending on what the results are, we will probably go into a pivotal trial to basically get NDX two and approved hopefully.

在哪一種腫瘤中？所以我認為這基本上是26年中期。然後到那時，根據結果，我們可能會進行關鍵試驗，以便獲得 NDX 2 並希望獲得批准。

So that's one, the second is you have two other molecules which are really nearing IND and then that you will hear about. But clearly, we will present medical data on NBX 201 before everything else. The third sort of news is that we have parties that are interested in our platform to collaborate with us. And that might be a news that we will definitely share if, if that happens.

這是其一，其次是還有另外兩種分子非常接近 IND，然後您就會聽到消息。但顯然，我們將首先提供有關 NBX 201 的醫療數據。第三種消息是，有各方對我們的平台感興趣，願意與我們合作。如果發生這種情況，我們一定會分享這個消息。

So those are the three things that you will see in ecology emerging programs. You will, you won't have any specific information except targets and the fact that they're in the clinic in emerging technologies that others want to collaborate with us on. And then MDX 2001 clinical data coming up over the next 18 months.

這就是您將在生態新興項目中看到的三件事。除了目標和他們在新興技術領域的臨床研究之外，你不會得到任何具體的訊息，而其他人希望與我們合作。然後 MDX 2001 臨床數據將在未來 18 個月內公佈。

That's helpful. And just maybe a quick follow up, obviously, this is going to be somewhat data dependent, and you know, dependent on the cancers where you see activity and sort of what standard of care is.

這很有幫助。也許只是快速的跟進，顯然，這將在某種程度上依賴數據，並且取決於您看到的癌症活動以及治療標準。

But do you ultimately envision combining your asset with other standard of care agents, whether that be chemotherapy, other IO or other targeted agents some more? Well, that just really depend on what we see from the data. Thanks so much.

但是，您最終是否設想將您的資產與其他標準治療藥物結合，無論是化療、其他IO還是其他標靶藥物？嗯，這實際上取決於我們從數據中看到什麼。非常感謝。

Absolutely. You, you understand it, I mean, it's clear your, your question shows that number one, we have to show effect as a monotherapy, right? Once we do and in what cancer and what subtype and what conditions, then the combination will be a self-evident step.

絕對地。你，你明白，我的意思是，很明顯你的問題表明，第一，我們必須顯示出單一療法的效果，對嗎？一旦我們針對哪種癌症、哪種亞型和哪種情況進行了研究，那麼組合將是一個不言而喻的進步。

As you know, in cancer development, we tend to essentially enter the development in phase one and phase two with patients who have already gone through other forms of therapies.

如您所知，在癌症發展中，我們傾向於在已經接受過其他形式治療的患者的情況下進入第一階段和第二階段的發展。

And failed. And once we show that we have an effect even on those patients, then we go forward from the fourth line to third line to second line. And as you go up to first line, you tend to combine with other therapies. Absolutely yes.

但失敗了。一旦我們證明這些患者有效果，我們就會從第四線前進到第三線、再到第二線。當您進入第一線時，您往往會結合其他療法。當然可以。

So your question is absolutely on target. And that would be the natural evolution of the development phase of a molecule like MDX 2001.

所以你的問題完全正確。這將是 MDX 2001 等分子發展階段的自然演化。

Makes a lot of sense. Look forward to seeing you guys soon.

非常有道理。期待很快見到你們。

Thank you. Take care.

謝謝。小心。

The next question comes from Michael Petusky of Barrington Research. Go ahead, please.

下一個問題來自 Barrington Research 的 Michael Petusky。請說。

Hey, good morning. So, Adam, in terms of your assumptions around BioReference for 25 what, what are the top line expectations, sort of flat modest growth, modest decline like, well, what are you thinking in terms of what, what it's going to take in terms of topline performance to get you to positive cash flow in that business?

嘿，早安。那麼，亞當，就您對 BioReference 的 25 年假設而言，對營收的預期是什麼，是平穩適度的增長，還是適度的下降，那麼您認為，在營收表現方面需要什麼才能讓您在該業務中獲得正現金流？

Hey, Mike, thanks. Thanks for the question. So, the short answer is we're going to give you good guidance in Q4 when we go through our full year guide.

嘿，麥克，謝謝。謝謝你的提問。因此，簡短的回答是，當我們制定全年指南時，我們將在第四季度為您提供良好的指導。

But you know, the shorter answer here is we don't expect big meaningful growth to achieve those numbers.

但你知道，簡短的回答是，我們並不期望透過大幅成長來實現這些數字。

Okay. Great. And, and then in, in terms of reality, you know, obviously this this a situation that really has never lived up to the, you know, the initial hope and, and I'm just, I'm just curious what, would it take to get this to a $50 million product?

好的。偉大的。然後，從現實角度來看，您知道，顯然這種情況實際上從未達到最初的希望，而且我只是好奇，要使其成為價值 5,000 萬美元的產品需要什麼？

I mean, is it, more you know, investment in, additional trials? Is it, more investment in sales? I mean, what, what is there a pathway to $50 million in annual revenue for Ray Aldi over the next few years? Thanks.

我的意思是，您知道這是否是對額外試驗的更多投資？是在銷售方面投入更多嗎？我的意思是，未來幾年，有什麼辦法可以讓 Ray Aldi 的年收入達到 5,000 萬美元？謝謝。

I'll take it. This is film.

我要買它。這是電影。

We're working on several initiatives there and there is a lot of interest in new data that we recently put together indicating that the lowering of PTH in patients with CKD, in whom it's elevated for a certain period of time at a certain level will delay the onset of or slow the progression of the chronic kidney disease and delay the requirement for dialysis.

我們正在進行多項計劃，大家對我們最近收集的新數據很感興趣，這些新數據表明，降低 CKD 患者的甲狀旁腺激素（在一定時間內保持在一定水平）會延緩慢性腎病的發作或減緩其進展，並延緩對透析的需求。

So having said that that is really a mouthful if that turns out to be holds up, if that data holds up and we hope we're hopeful that it will the data looks good, the thought leaders are buying into it and we're about to present this as part of a new marketing program. So, we'll see what happens.

所以話雖如此，如果事實證明這一說法成立，如果這些數據成立，我們希望數據看起來不錯，思想領袖們會接受這一說法，我們即將把它作為新行銷計劃的一部分提出來，這確實是一件令人難以接受的事情。所以，我們看看會發生什麼。

Okay. All right, very good. Thank you. Actually, Adam one more. If I could one more quick one for, for Adam, the sherry, purchase. Is it, likely that you guys when the this initial authorization? I mean, will there be another official authorization or we got like what what's sort of the future of the share we purchase the common stock. Thanks.

好的。好的，非常好。謝謝。實際上，亞當還有一個。如果我可以再快一點，為亞當購買雪莉酒。你們可能已經獲得初步授權了嗎？我的意思是，是否會有另一個官方授權，或者我們會知道我們購買的普通股的未來會如何。謝謝。

Yeah. So, you know, we've used about a third of the what the board authorized earlier this year and to the extent, you know, we have capital allocation to a program and, and we don't have enough under the program. We'll announce an expanded program.

是的。所以，你知道，我們已經使用了董事會今年早些時候批准的資金的三分之一，你知道，我們對一個項目進行了資本分配，但該項目下的資金不足。我們將宣布一項擴展計劃。

Phil alluded to that in his comments. So, I, I'd say that's, you'll hear about it through another announcement when we, when we get there.

菲爾在他的評論中提到了這一點。所以，我想說，當我們到達那裡時，你會透過另一個公告聽到這個消息。

All right, very good.

好的，非常好。

Thanks guys.

謝謝大家。

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。我想將會議交還給弗羅斯特博士，請他作最後發言。

Well, thank you for participating and for your excellent questions. We look forward to meeting with you again in a few months and hopefully we'll have an even more interesting story to tell at that point.

好吧，感謝您的參與以及提出的優秀問題。我們期待幾個月後再次與您見面，希望到那時我們能講述更有趣的故事。

The conference is 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。