OPKO Health Inc (OPK) 2024 Q2 法說會逐字稿

Good day, and welcome to the OPKO Health second-quarter 2024 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.

美好的一天，歡迎參加 OPKO Health 2024 年第二季財務業績電話會議。（操作員說明）請注意，正在記錄此事件。我現在想把會議交給伊馮·布里格斯。請繼續。

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

謝謝您，接線員，下午好。我是 LHA 的伊馮布里格斯 (Yvonne Briggs)。感謝大家參加今天的電話會議，討論 OPKO Health 2024 年第二季的財務表現。

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. 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. The conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, August 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.

我想提醒您，管理層在本次電話會議中所做的除歷史事實陳述之外的任何陳述都將被視為前瞻性的，因此將受到可能對公司預期結果產生重大影響的風險和不確定性的影響。這些前瞻性陳述包括但不限於本公司向 SEC 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提交的 SEC 報告中所述的各種風險。電話會議包含時效性訊息，僅截至直播日期（2024 年 8 月 7 日）準確。除法律要求外，OPKO 不承擔修改或更新任何前瞻性聲明以反映本次電話會議之後發生的事件或情況的義務。

Before we begin, let me review the format of today's call. 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 followed by OPKO's pharmaceutical business. After that, Adam Logal, OPKO's CFO, will review the company's second-quarter financial results, 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 博士將宣布電話會議開始。隨後，副主席兼總裁 Elias Zerhouni 博士將概述 BioReference Health，隨後介紹 OPKO 的製藥業務。之後，OPKO 財務長 Adam Logal 將審查公司第二季的財務業績，然後我們將開始提問。

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 recently made a few announcements focused on optimizing our balance sheet and enhancing shareholder value. We entered into a $250 million note purchase agreement with HealthCare Royalty that is secured by the gross profit share arrangement we have with Pfizer, our global commercial partner for NGENLA. The transaction allows us to retain a significant portion of the near-term profit share payments and also provide substantial upside opportunities long-term. We maintain rights to the full $100 million of remaining potential milestone payments from Pfizer.

下午好，感謝您今天加入我們。我們最近發布了一些公告，重點是優化我們的資產負債表和提高股東價值。我們與 HealthCare Royal 簽訂了 2.5 億美元的票據購買協議，該協議由我們與 NGENLA 的全球商業合作夥伴輝瑞 (Pfizer) 的毛利份額安排作為擔保。該交易使我們能夠保留很大一部分近期利潤分成付款，並提供大量的長期上行機會。我們保留從輝瑞獲得全額 1 億美元剩餘潛在里程碑付款的權利。

The proceeds provide financial flexibility to advance our R&D efforts for ModeX and its multispecific antibody programs, other OPKO programs, and the option to repurchase shares of our common stock and convertible notes. As you know, our Board authorized a $100 million share repurchase program, which at present prices, represents approximately 10% of our shares outstanding. This share buyback program represents an attractive investment opportunity given our confidence in the business and our strategy. In general, our long-acting growth hormone therapy continues to gain traction as Pfizer expands its launch with the product now being sold globally. NGENLA competes in a large and expanding global market opportunity.

所得款項提供了財務靈活性，以推進我們對 ModeX 及其多特異性抗體項目、其他 OPKO 項目的研發工作，以及回購普通股和可轉換票據的選擇權。如您所知，我們的董事會批准了一項 1 億美元的股票回購計劃，以目前的價格計算，該計劃約占我們已發行股票的 10%。鑑於我們對業務和策略的信心，此次股票回購計畫代表了一個有吸引力的投資機會。總的來說，隨著輝瑞擴大其上市範圍，我們的長效生長激素療法繼續受到關注，該產品現已在全球銷售。NGENLA 在龐大且不斷擴大的全球市場機會中競爭。

As mentioned on our last conference call, the IND for ModeX 2001 was cleared by the FDA for us to proceed to a Phase 1 clinical trial to treat solid tumors. Our goal is to develop a first-in-class tetraspecific antibody that activates T-cells and survival enhancement receptors to optimize sustained cancer treatment. The first patient is expected to be dosed in the coming weeks. In addition, we're on track to begin clinical trials of our Epstein-Barr vaccine candidate with our partner, Merck, later this year. Elias will provide more detail on these and other ModeX pipeline programs in a moment.

正如我們在上次電話會議中提到的，ModeX 2001 的 IND 已獲得 FDA 批准，可以進行治療實體瘤的 1 期臨床試驗。我們的目標是開發一種一流的四特異性抗體，可活化 T 細胞和生存增強受體，以優化持續的癌症治療。預計第一名患者將在未來幾週內接受給藥。此外，我們預計在今年稍後與我們的合作夥伴默克公司開始對 Epstein-Barr 候選疫苗進行臨床試驗。Elias 稍後將提供有關這些和其他 ModeX 管道程式的更多詳細資訊。

As for BioReference Health, we're making steady progress on the return to profitability, which will accelerate when we closed the announced transaction with Labcorp. We are continuing to progress our collaboration with Entera Bio to develop oral tablet formulations of our proprietary long-acting GLP-2 peptide and oxyntomodulin analogues using Entera's proprietary N-Tab oral delivery technology. Entera recently announced in vivo PK results for oral GLP-2 tablets to treat short bowel syndrome and other GI disorders. Plasma levels compared favorably with those reported for teduglutide, a GATTEX product. Pharmacology and incremental PK were expected early in the second half of 2024. With that brief overview, I'll turn it over to Elias. Elias?

至於 BioReference Health，我們在獲利能力復原方面正在穩步取得進展，當我們完成與 Labcorp 宣布的交易時，獲利能力的復原將會加速。我們正在繼續推動與 Entera Bio 的合作，利用 Entera 專有的 N-Tab 口服給藥技術開發我們專有的長效 GLP-2 勝肽和胃泌酸調節素類似物的口服片配方。Entera 最近公佈了口服 GLP-2 片劑治療短腸症候群和其他胃腸道疾病的體內 PK 結果。血漿濃度優於報道的 GATTEX 產品替度魯肽的血漿濃度。藥理學和增量 PK 預計將於 2024 年下半年初進行。有了這個簡短的概述，我將把它交給 Elias。埃利亞斯？

Thank you, Phil, and good afternoon, everyone. To echo Phil's comments, we are well positioned to execute on our strategy. This includes advancing our multi-specific pipeline at ModeX and streamlining BioReference Health operations to return to profitability.

謝謝菲爾，大家下午好。為了呼應菲爾的評論，我們已經做好了執行我們策略的準備。這包括推進我們在 ModeX 的多特異性產品線以及簡化 BioReference Health 營運以恢復利潤。

Let me start with BioReference Health. We are on track to close our transaction with Labcorp in late September or early October. After this transaction closes, our ongoing diagnostic operations will include our national oncology and urology franchises and our full suite of testing services in New York and New Jersey. This transaction will streamline our remaining diagnostics business by enhancing our focus on core testing operations and supporting our efforts to reestablish profitability.

讓我從 BioReference Health 開始。我們預計在 9 月底或 10 月初完成與 Labcorp 的交易。此次交易完成後，我們正在進行的診斷業務將包括我們的全國腫瘤學和泌尿科特許經營權以及我們在紐約和新澤西州的全套測試服務。這項交易將加強我們對核心測試業務的關注並支持我們重建盈利能力的努力，從而簡化我們剩餘的診斷業務。

As an ongoing initiative, we continue to improve BioReference's performance and in turn build value. Our goals remain clear, and that is to reduce costs, to improve efficiency, and to enhance productivity as well as to drive top line growth. For instance, at the end of Q2, our FTE number at BioReference was 2,697 and this will drop to approximately 2,100 following the transfer of FTEs to Labcorp at closing of the transaction. This geographic refocusing of our operations will help further reduce our cost structures in coming quarters.

作為一項持續的舉措，我們不斷提升 BioReference 的績效，進而創造價值。我們的目標仍然明確，那就是降低成本、提高效率、提高生產力以及推動收入成長。例如，在第二季末，我們在 BioReference 的 FTE 人數為 2,697 人，在交易結束時將 FTE 轉移到 Labcorp 後，這一數字將降至約 2,100 人。我們業務的地域重新調整將有助於在未來幾季進一步降低我們的成本結構。

Now oncology remains a growing and high-value segment of the diagnostics business. In the second quarter, testing volume increased 8% and revenue overall increased 6% versus the year-ago quarter due to demand for our innovative platform and competitive turnaround times.

現在，腫瘤學仍然是診斷業務中不斷增長的高價值部分。由於對我們創新平台的需求和具有競爭力的周轉時間，第二季的測試量比去年同期成長了 8%，整體營收成長了 6%。

As I mentioned last quarter, the growth in this segment is being driven by collaborations with large cancer centers and mid-level health systems. We continue to expand these relationships as it is a costly proposition for a health system to run the specialty oncology tests in-house.

正如我上季度提到的，該領域的成長是由與大型癌症中心和中級衛生系統的合作所推動的。我們繼續擴大這些關係，因為對於衛生系統來說，在內部運行專業腫瘤學測試是一項成本高昂的提議。

Additionally, we grew our oncology menu in the second quarter with the addition of IHC stains for neuroendocrine, rhabdoid, and gastric markers and moved some of our somatic markers to new advanced testing platforms. This enables us to stay best-in-class with our portfolio and brings value to our clients and the patients they serve. Our 4Kscore test for prostate cancer continues to perform well.

此外，我們在第二季擴大了腫瘤學菜單，增加了神經內分泌、橫紋肌樣和胃標記物的 IHC 染色，並將我們的一些體細胞標記物轉移到新的先進測試平台。這使我們能夠透過我們的產品組合保持一流的水平，並為我們的客戶及其服務的患者帶來價值。我們的前列腺癌 4Kscore 測試繼續表現良好。

Now moving to our pharmaceutical segment. I'd like to start with ModeX programs. And specifically, the MDX2001 program that was mentioned by Phil, which has been approved by FDA to progress into the clinical stage. We expect to dose our first patient in the Phase 1 trial for our tetra specific LASER program for solid tumors in the coming weeks.

現在轉向我們的製藥領域。我想從 ModeX 程式開始。具體來說，就是Phil提到的MDX2001項目，該項目已經獲得FDA批准進入臨床階段。我們預計在未來幾週內為實體瘤四特異性雷射計畫的一期試驗中的第一位患者進行給藥。

This Phase 1 open-label trial is expected to enroll 45 cancer patients with a variety of solid tumors, including lung, breast, prostate, and pancreatic cancers with the goal to focus on certain tumor types that are responding to treatment and then expand the trial accordingly. We anticipate a total of six clinical sites to evaluate safety, tolerability, and pharmacokinetics as well as early antitumor activity. Two sites are already enrolling patients. And four more will come online very promptly.

這項一期開放標籤試驗預計將招募45 名患有多種實體瘤的癌症患者，包括肺癌、乳腺癌、前列腺癌和胰腺癌，目標是重點關注對治療有反應的某些腫瘤類型，然後擴大試驗範圍因此。我們預計總共有六個臨床中心來評估安全性、耐受性、藥物動力學以及早期抗腫瘤活性。兩個站點已經在招募患者。還有四個很快上線。

In addition, we look forward to advancing our other immuno-oncology programs through IND-enabling studies and expect to enter the clinic next year with an immune modulator multi-specific antibody known as [MDX2004] that could potentially be used in a large number of oncology and non-oncology indications. We continue to actively evaluate possible partnerships for our portfolio assets, seeking nondilutive funding for several of our programs.

此外，我們期待透過支持 IND 的研究來推進我們的其他免疫腫瘤學項目，並預計明年進入臨床，名為 [MDX2004] 的免疫調節劑多特異性抗體可能會用於大量治療腫瘤學和非腫瘤學適應症。我們繼續積極評估我們的投資組合資產的可能合作夥伴關係，為我們的幾個項目尋求非稀釋性資金。

Another program we expect to enter the clinic this year or early next year is MDX2201, which is our Epstein-Barr virus multi-valent nanoparticle vaccine. Merck is our collaboration partner who funds all preclinical work performed by the ModeX team until IND. At which time, Merck will assume all development and commercialization aspects of this novel vaccine for EBV.

我們預計今年或明年初進入臨床的另一個項目是 MDX2201，這是我們的 Epstein-Barr 病毒多價奈米顆粒疫苗。默克是我們的合作夥伴，資助 ModeX 團隊在 IND 之前進行的所有臨床前工作。屆時，默克將承擔這種新型 EBV 疫苗的所有開發和商業化工作。

Pending regulatory clearance, our goal is to begin studies in mid-2024, early 2025. We also have a very active collaboration with BARDA to develop our multi-specific antibodies against known variants of SARS-CoV-2 for the treatment and prevention of COVID-19. This program is also progressing very well and is entering the pre-IND-enabling stage of development. BARDA, as we mentioned before, granted us $59 million to fund R&D and clinical evaluation through Phase 1. Additional funding of up to $109 million may be available to accelerate the COVID program and target other biodefense threats as well as develop a platform with gene-based delivery methods for use against future pandemics.

在等待監管部門批准之前，我們的目標是在 2024 年中期、2025 年初開始研究。我們也與 BARDA 進行了非常積極的合作，開發針對已知 SARS-CoV-2 變異體的多特異性抗體，用於治療和預防 COVID-19。該計劃也進展順利，正在進入 IND 啟動前的開發階段。正如我們之前提到的，BARDA 撥款 5,900 萬美元，用於資助第一階段的研發和臨床評估。可能會提供高達 1.09 億美元的額外資金，以加速新冠病毒計劃並針對其他生物防禦威脅，並開發一個具有基於基因的交付方法的平台，用於應對未來的流行病。

Now switching gears to NGENLA. Pfizer has launched a pediatric long-acting growth hormone drug in all major global markets, and we expect Pfizer to continue to penetrate markets and gain share for this once-weekly drug as patients shifts from the daily products. We're working with Pfizer on two additional indications, including growth hormone deficiency in adults and other pediatric applications. As you know, OPKO is entitled to an additional $100 million in potential milestone payments related to these two indications.

現在切換到 NGENLA。輝瑞在全球所有主要市場推出了一種兒科長效生長激素藥物，隨著患者從日常產品轉向，我們預計輝瑞將繼續滲透市場並獲得這種每週一次的藥物的份額。我們正在與輝瑞合作研究另外兩個適應症，包括成人生長激素缺乏症和其他兒科應用。如您所知，OPKO 有權獲得與這兩個適應症相關的額外 1 億美元的潛在里程碑付款。

Finally, Rayaldee continues to perform as expected with new evidence showing its potential to improve outcomes in chronic kidney disease 3 and 4 stage patients with secondary hyperparathyroidism. So in summary, I think we've made significant progress in both segments of the business as we get closer to returning BioReference Health to profitability and in parallel advancing our promising ModeX pipeline as programs enter the clinic and progress through clinical testing. I will now turn the call over to Adam Logal to discuss our second-quarter financial results. Adam?

最後，Rayaldee 的表現持續符合預期，新證據顯示其有可能改善患有繼發性副甲狀腺功能亢進症的慢性腎病 3 期和 4 期患者的預後。總而言之，我認為我們在這兩個業務領域都取得了重大進展，因為我們越來越接近讓BioReference Health 恢復盈利，同時隨著計畫進入診所並通過臨床測試取得進展，我們也同時推進我們有前景的ModeX 管道。我現在將把電話轉給 Adam Logal，討論我們第二季的財務表現。亞當？

Thank you, Elias. As Phil and Elias have discussed, the first half of 2024 was transformational for our balance sheet as we positioned ourselves to realize and demonstrate the inherent value of our assets for our shareholders. We initiated and completed five significant transactions, which Phil and Elias have already discussed in part, including the refinancing of our convertible notes in January, which allowed us to extend the maturity of our notes, repurchase 55 million shares of common stock and added approximately $25 million of cash to our balance sheet while working to realize the significant value of our underlying assets.

謝謝你，埃利亞斯。正如 Phil 和 Elias 所討論的那樣，2024 年上半年對我們的資產負債表來說是一場變革，因為我們的定位是為股東實現並展示我們資產的內在價值。我們發起並完成了五項重大交易，Phil 和Elias 已經部分討論過，包括1 月份對我們的可轉換票據進行再融資，這使我們能夠延長票據的期限、回購5500 萬股普通股並增加約25 美元百萬現金到我們的資產負債表上，同時努力實現我們基礎資產的巨大價值。

We then announced the Labcorp transaction to position BioReference to return to profitable growth through focus on certain strategic and geographic customer segments as well as demonstrate the value of the remaining business of BioReference. We announced the HealthCare Royalty financing transaction recently, pulling forward $250 million of cash while maintaining significant upside in the gross profit share payments in all remaining milestone payments.

隨後，我們宣布了 Labcorp 交易，旨在透過專注於某些策略和地理客戶群，使 BioReference 恢復獲利成長，並展示 BioReference 剩餘業務的價值。我們最近宣布了醫療保健版稅融資交易，籌集了 2.5 億美元現金，同時在所有剩餘的里程碑付款中保持毛利份額付款的大幅上漲。

Fourth, we announced an additional common stock buyback of up to $100 million. And finally, we've begun to monetize a portion of our holdings in GeneDx. We look at all options of enhancing shareholder value, and we'll continue to execute operational through strategic transactions like the ones I just mentioned. This includes opportunities to realize the inherent value of our assets and through the return of capital to shareholders through our stock buyback program as well as repurchasing our convertible notes as market conditions allow. We expect to have a significant cash balance, which we will use to invest in our highest priority R&D programs and to fund prudent equity repurchases.

第四，我們宣布額外回購最多 1 億美元的普通股。最後，我們開始將持有的部分 GeneDx 貨幣化。我們會考慮提高股東價值的所有選擇，並將繼續透過我剛才提到的策略交易來執行營運。這包括實現我們資產的內在價值的機會，以及透過我們的股票回購計劃向股東返還資本以及在市場條件允許的情況下回購我們的可轉換票據。我們預計將擁有大量現金餘額，用於投資我們最優先的研發項目並為審慎的股權回購提供資金。

Before I move to the financial results for the quarter, I wanted to summarize the key terms of our recent HealthCare Royalty transaction. Through this agreement, we've accelerated the value realization of a portion of our partnership with Pfizer while retaining $100 million of milestone payments.

在介紹本季的財務表現之前，我想總結我們最近的醫療保健版稅交易的關鍵條款。透過這項協議，我們加快了與輝瑞合作夥伴關係的部分價值實現，同時保留了 1 億美元的里程碑付款。

The agreement also allows us to retain near-term upside and the long-term potential of the collaboration at a cost of capital below our benchmarks. The transaction was structured as a royalty bond secured by the gross profit share payments we received from Pfizer. This will be accounted for as debt, meaning the balance sheet will reflect the cash and principal balance of what we receive from Healthcare Royalty.

該協議還使我們能夠以低於我們基準的資本成本保留合作的近期優勢和長期潛力。此交易的結構為特許權使用費債券，由我們從輝瑞收到的毛利份額付款作為擔保。這將被記為債務，這意味著資產負債表將反映我們從醫療保健版稅收到的現金和本金餘額。

Revenue, gross margin, and operating income will continue to reflect the economics of our existing relationship with Pfizer. However, interest expense will increase as a result of this financing. For the first four years, the payments received from Pfizer exceeds interest expense, all excess will be paid to OPKO. Shortfalls, if any, will be treated as payments in kind and increase the principal balance.

收入、毛利率和營業收入將繼續反映我們與輝瑞現有關係的經濟效益。然而，本次融資的利息支出將會增加。在前四年，從輝瑞收到的付款超過利息支出，所有超出部分將支付給 OPKO。如有短缺，將被視為實物支付並增加本金餘額。

After the first four years, all payments from Pfizer will be retained by Healthcare Royalty, first repaying interest and any excess to pay down the principal, again, with any interest shortfalls being treated as payments in kind accruing to principal. When considering our internal forecast and base-case model, we anticipate the royalty bond will be fully repaid within eight years with our downside models showing repayment within 10 years. The interest rate is based on SOFR plus 7.5% with a 4% SOFR floor.

前四年後，輝瑞的所有付款將由 Healthcare Royal 保留，首先償還利息和任何超額部分以償還本金，再次，任何利息短缺都將被視為本金應計的實物付款。在考慮我們的內部預測和基本情況模型時，我們預計特許權使用費債券將在八年內全額償還，而我們的下行模型顯示在 10 年內償還。利率基於 SOFR 加 7.5%，SOFR 下限為 4%。

Now moving to the financial results of our diagnostics segment. Revenue increased 2% to $129.4 million for Q2 2024 compared with $127.1 million for the 2023 period. This increase was driven by strong volume and price growth in our oncology segment, partially offset by declines in our women's health and clinical testing businesses.

現在轉向我們診斷部門的財務表現。2024 年第二季的營收成長 2%，達到 1.294 億美元，而 2023 年同期的營收為 1.271 億美元。這一增長是由我們的腫瘤領域銷售和價格的強勁增長推動的，但部分被我們的女性健康和臨床檢測業務的下降所抵消。

Costs and expenses decreased 9% or $15.3 million to $156 million for the second quarter of 2024 from $171.3 million for the 2023 period. Operating loss for our diagnostics segment narrowed by 40% to $26.6 million for the second quarter of 2024 compared to the second quarter of 2023's $44.3 million operating loss. Sequentially, we also saw an improvement in operating loss of $7.8 million, reflecting the realization of the cost reduction programs outlined last quarter.

2024 年第二季的成本和費用從 2023 年期間的 1.713 億美元減少 9%，即 1530 萬美元至 1.56 億美元。與 2023 年第二季 4,430 萬美元的營運虧損相比，2024 年第二季我們診斷部門的營運虧損縮小了 40%，至 2,660 萬美元。隨後，我們也看到營運虧損減少了 780 萬美元，反映出上季概述的成本削減計畫的實現。

Revenue from the assets being sold to Labcorp represented $25.5 million of revenue and related costs and expenses totaled $32.5 million during the second quarter of 2024. Depreciation and amortization expense for the diagnostics segment were $6.2 million and $8.6 million for the 2024 and 2023 periods, respectively.

2024 年第二季度，出售給 Labcorp 的資產帶來的收入為 2,550 萬美元，相關成本和支出總計 3,250 萬美元。2024 年和 2023 年期間診斷部門的折舊和攤提費用分別為 620 萬美元和 860 萬美元。

The team at BioReference continues to work tirelessly to execute our plan to return this business to profitability, and they continue to make significant strides towards that objective. I'll provide some additional clarity on the details and timing of these significant improvements when I provide guidance in a few moments.

BioReference 團隊繼續不懈地努力執行我們的計劃，使該業務恢復盈利，並且他們繼續朝著這一目標取得重大進展。當我稍後提供指導時，我將進一步澄清這些重大改進的細節和時間安排。

Moving to our pharmaceuticals segment. Revenue was $52.8 million for the second quarter of 2024 compared with $138.4 million for the 2023 period. As a reminder, the 2023 period included a $90 million milestone payment from Pfizer for the regulatory approval of NGENLA in the US. Revenue from products, including our international pharmaceutical businesses, was $40.5 million compared to $43.5 million for the comparable period of '23.

轉向我們的製藥領域。2024 年第二季的營收為 5,280 萬美元，而 2023 年第二季的營收為 1.384 億美元。需要提醒的是，2023 年期間，輝瑞為 NGENLA 在美國的監管批准支付了 9,000 萬美元的里程碑付款。產品收入（包括我們的國際製藥業務）為 4,050 萬美元，而 2023 年同期為 4,350 萬美元。

Despite the challenging foreign currency environment, the profitability profile of the business approved against our expectations. Product revenue includes revenue from Rayaldee of $7.2 million, which was similar to 2023's $7.7 million, reflecting a slight decrease in the number of bottles shipped, partially offset by increased pricing.

儘管外匯環境充滿挑戰，但該業務的獲利狀況超出了我們的預期。產品收入包括來自 Rayaldee 的 720 萬美元收入，與 2023 年的 770 萬美元相似，反映出裝運的瓶子數量略有減少，但部分被價格上漲所抵消。

Revenue from the transfer of IP was $12.3 million for the second quarter of 2024 compared to $94.9 million for the 2023 quarter, which as I mentioned, included $90 million from Pfizer for the US regulatory approval of NGENLA. Our US gross profit share from Pfizer was $6.3 million during the second quarter of 2024 compared to $3.8 million for the 2023 period. In addition, the second quarter of 2024 includes $5 million of other IP revenue related to our BARDA agreement.

2024 年第二季智慧財產權轉讓收入為 1,230 萬美元，而 2023 年季度為 9,490 萬美元，正如我所提到的，其中包括輝瑞公司為美國監管機構批准 NGENLA 提供的 9,000 萬美元。2024 年第二季度，我們從輝瑞公司獲得的美國毛利份額為 630 萬美元，而 2023 年第二季為 380 萬美元。此外，2024 年第二季包括與我們的 BARDA 協議相關的 500 萬美元其他智慧財產權收入。

Costs and expenses for our pharmaceuticals segment were $77.6 million for the second quarter of 2024 compared with $74.7 million for the 2023 period. Research and development expenses were $23.7 million compared to $17.5 million a year ago. Research and development expense increased as a result of our activities for the ModeX development programs, including the recently commenced Phase 1 clinical trial for our first immuno-oncology program.

2024 年第二季我們製藥部門的成本和費用為 7,760 萬美元，而 2023 年第二季為 7,470 萬美元。研發費用為 2,370 萬美元，去年同期為 1,750 萬美元。由於我們的 ModeX 開發計劃活動（包括最近開始的第一個免疫腫瘤計劃的一期臨床試驗），研發費用增加。

The resulting operating loss for the quarter ended June 30, 2024, was $24.8 million compared with operating income of $63.3 million for the second quarter of 2023. Depreciation and amortization expense for the pharmaceutical segment related to intangible assets were unchanged at $17.9 million and $17.8 million for the 2024 and 2023 second quarters.

截至 2024 年 6 月 30 日的季度營運虧損為 2,480 萬美元，而 2023 年第二季的營運收入為 6,330 萬美元。2024 年和 2023 年第二季度，與無形資產相關的製藥部門的折舊和攤銷費用保持不變，分別為 1,790 萬美元和 1,780 萬美元。

Turning to our consolidated financial results. For the second quarter of 2024, we reported a net loss of $10.3 million or $0.01 per share compared with a net loss of $19.6 million or $0.03 per share for the 2023 period. Net loss for the second quarter of 2024 included a noncash unrealized gain on our investment in GeneDx of $60.5 million compared to a non-realized loss of $19.9 million for the 2023 period.

轉向我們的綜合財務表現。2024 年第二季度，我們報告淨虧損 1,030 萬美元，即每股 0.01 美元，而 2023 年期間的淨虧損為 1,960 萬美元，即每股 0.03 美元。2024 年第二季的淨虧損包括我們對 GeneDx 投資的非現金未實現收益 6,050 萬美元，而 2023 年期間的未實現虧損為 1,990 萬美元。

In addition, as I've mentioned, the 2023 period benefited from the non-recurring $90 million milestone payment from Pfizer. As we look ahead, providing financial guidance with the following assumptions. For our pharmaceutical segment, global sales of Genotropin for the first half of 2024, as reported by Pfizer, were $349 million. Pfizer has not separately reported sales of NGENLA.

此外，正如我所提到的，2023 年期間受益於輝瑞的 9,000 萬美元非經常性里程碑付款。展望未來，我們根據以下假設提供財務指導。對於我們的製藥部門，根據輝瑞報告，2024 年上半年 Genotropin 的全球銷售額為 3.49 億美元。輝瑞尚未單獨報告 NGENLA 的銷售額。

However, we continue to observe consistent prescription growth globally for NGENLA as reported by both IQVIA and Symphony. We were pleased to see that Pfizer has begun to realize the cost benefits of the increased manufacturing scale of NGENLA during the second quarter. And as a result, we believe that the gross profit share payment beginning late in the third quarter will reflect this improvement in gross profit for the product. As such, we expect to receive gross profit share payments from Pfizer of $7 million to $9 million in Q3 and $15 million to $20 million for the full second half of 2024.

然而，正如 IQVIA 和 Symphony 報告的那樣，我們繼續觀察到 NGENLA 的全球處方量持續成長。我們很高興看到輝瑞在第二季開始意識到 NGENLA 生產規模擴大所帶來的成本效益。因此，我們認為從第三季末開始的毛利份額支付將反映該產品毛利的改善。因此，我們預計第三季將從輝瑞獲得 700 萬至 900 萬美元的毛利份額付款，並在 2024 年下半年獲得 1,500 萬至 2,000 萬美元的毛利份額付款。

We assume a stable foreign currency exchange rate for ex-US pharmaceutical business. And R&D expenses for the third quarter of 2024 will reflect higher activities related to our ModeX program, including CMC and efforts related to our immuno-oncology trial. A portion of the increased activities will continue to be funded by our BARDA agreement.

我們假設美國以外的製藥業務的外幣匯率穩定。2024 年第三季的研發費用將反映與我們的 ModeX 計畫相關的更多活動，包括 CMC 和與我們的免疫腫瘤學試驗相關的工作。部分增加的活動將繼續由我們的 BARDA 協議提供資金。

For our diagnostics segment, we anticipate the closing of the Labcorp transaction to occur by the end of September or early October, but have included the results for the full quarter in our outlook. This significant milestone allows us to rationalize our fixed cost structure and provides the foundation for BioReference to return to profitability.

對於我們的診斷部門，我們預計 Labcorp 交易將於 9 月底或 10 月初完成，但我們的展望中包含了整個季度的結果。這一重要的里程碑使我們能夠合理化我們的固定成本結構，並為 BioReference 恢復盈利奠定基礎。

We are continuing our multi-year, multi-phase cost reduction program and this program is expected to include operational efficiencies and product portfolio rationalization. This program is focused on 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 expect to begin realizing during the third quarter of 2024.

我們正在繼續實施多年、多階段的成本削減計劃，該計劃預計將包括營運效率和產品組合合理化。該計劃的重點是降低固定基礎設施成本，預計到 2024 年底每年節省約 2,500 萬美元，其中部分成本預計將在 2024 年第三季開始實現。

The one-time costs to achieve the savings with the near-term phase of the program are expected to be approximately $40 million and primarily includes severance and facility closure costs. These costs will be recorded primarily in 2024 with cash outlays expected through 2028. In addition, we have taken action on a number of our RCM programs, including implementing a price increase during the third quarter for certain testing modalities, including our oncology offerings, which are expected to result in an overall annual increase of revenue of $8 million to $10 million.

該計劃近期階段實現節省的一次性成本預計約為 4000 萬美元，主要包括遣散費和設施關閉費用。這些成本將主要在 2024 年記錄，預計現金支出將持續到 2028 年。此外，我們也對一些 RCM 計畫採取了行動，包括在第三季對某些測試模式（包括我們的腫瘤產品）實施價格上漲，預計這將導致年度總收入增加 800 萬美元1000萬美元。

Before considering any non-recurring costs that may result from our restructuring and other non-recurring expenses, we expect costs and expenses in Q3 to decline approximately $3 million to approximately $153 million to $156 million without giving effect to the approximately $33 million of costs related to the assets conveyed to Labcorp. We expect to realize a gain net of transaction expenses of approximately $114 million to $120 million related to the closing of the Labcorp agreement. As a result, we expect the following for the third quarter of 2024.

在考慮重組和其他非經常性費用可能產生的任何非經常性費用之前，我們預計第三季的成本和費用將下降約300 萬美元至約1.53 億至1.56 億美元，而不影響約3,300 萬美元的相關成本轉移給 Labcorp 的資產。我們預計，扣除與 Labcorp 協議完成相關的交易費用後，我們將實現約 1.14 億至 1.2 億美元的淨收益。因此，我們預計 2024 年第三季將出現以下情況。

Total revenues between $180 million and $185 million, with revenue from services between $125 million and $129 million, including $24 million to $25 million from the assets, which will be sold to Labcorp. Revenue from product sales of $40 million to $43 million and other revenue between $10 million and $14 million, inclusive of the Pfizer gross profit share, which is estimated to be between $7 million and $9 million.

總收入在 1.8 億至 1.85 億美元之間，其中服務收入在 1.25 億至 1.29 億美元之間，其中資產收入為 2,400 萬至 2,500 萬美元，這些資產將出售給 Labcorp。產品銷售收入為 4,000 萬至 4,300 萬美元，其他收入為 1,000 萬至 1,400 萬美元，其中包括輝瑞毛利潤份額，估計為 700 萬至 900 萬美元。

We expect third-quarter cost and expenses to be between $238 million and $245 million, excluding the non-recurring expenses I previously mentioned. R&D expense is expected to increase, to be between $24 million and $28 million, with the range being dependent on certain CMC activities for our ModeX programs. And we expect depreciation and amortization expense to be approximately $24 million.

我們預計第三季的成本和費用將在 2.38 億美元至 2.45 億美元之間，不包括我之前提到的非經常性費用。研發費用預計將增加到 2,400 萬美元至 2,800 萬美元之間，具體範圍取決於我們 ModeX 專案的某些 CMC 活動。我們預計折舊和攤提費用約為 2,400 萬美元。

This concludes our prepared remarks. Thank you all for your attention. And now operator, let's open the call for questions.

我們準備好的演講到此結束。感謝大家的關注。現在接線員，讓我們開始提問。

(Operator Instructions) Maury Raycroft, Jefferies.

（操作員說明）Maury Raycroft，Jefferies。

Congrats on the progress for the quarter. Maybe first one just on NGENLA. So it seems like the guidance for second half of this year is narrowing and lowering a little bit. Just checking if anything changed commercially since last quarter? Or is this related to just getting experience with the gross profit share economics? Or is it due to inventory or anything else commercially that Pfizer could be seeing?

恭喜本季取得的進展。也許第一個就在 NGENLA 上。因此，今年下半年的指導似乎正在收窄並略有下降。只是檢查自上季度以來商業上是否有任何變化？或者這與獲得毛利分享經濟學經驗有關？或者是由於庫存或輝瑞可能看到的其他商業原因？

Yes. No, this is tied into the inventory adjustment that we talked about last quarter, Maury. So it's just the final pull-through of certain territories. That adjustment is getting flushed out. We had hoped it would be earlier in the third quarter. It looks like it's going to be late third quarter based on our internal factors. So that's why the annual range came down to kind of the mid-30s from potentially size 40.

是的。不，這與我們上季度討論的庫存調整有關，莫里。所以這只是某些地區的最後拉通。這種調整正在被淘汰。我們原本希望是在第三季早些時候。根據我們的內部因素，看起來將是第三季末。這就是為什麼每年的尺寸範圍從潛在的 40 碼降至 30 碼左右。

Got it. Okay. That's helpful. And then is it possible to book and timing for when Pfizer could aim to refile for the adult growth hormone opportunity? And is there more you can say on the status and plans for the additional pediatric indications?

知道了。好的。這很有幫助。那麼輝瑞是否有可能重新申請成人生長激素機會並確定何時重新申請？關於其他兒科適應症的現狀和計劃，您還有什麼可以說的嗎？

So on the pediatric indications, so Pfizer is planning their registration studies to bring those forward for the global launch for those additional indications. We haven't provided any specific timelines for those trials to be completed yet, Maury, but I think more to come. They're definitely actively working on the programs. As it relates to the US for the adult, they're still working with their team to formulate their strategy for the US approval.

因此，在兒科適應症方面，輝瑞正在計劃他們的註冊研究，以推動這些額外適應症的全球上市。莫里，我們尚未提供完成這些試驗的任何具體時間表，但我認為還會有更多。他們肯定正在積極致力於這些計劃。由於這與美國的成年人相關，他們仍在與團隊合作制定獲得美國批准的策略。

And then last question, and I'll hop back in the queue. Just for the deal closing with BioReference, thanks for providing the clarity into when you expect that to happen. Is there anything else you can share about where you're at with the process? And what are specific gating factors to the closing?

然後是最後一個問題，我會跳回隊列。就與 BioReference 達成的交易而言，感謝您明確說明您預計何時會發生。關於您目前的流程，還有什麼可以分享的嗎？成交的具體限制因素有哪些？

Yes. So right now, it's really focused heavily on the integration steps between the clients in Labcorp. So those are the main gating items. There's a couple of minor regulatory filings that just need to get cleared up, but all of the major hurdles are behind us, which is why we have pretty certain clarity, but this transaction will get closed late September, early October.

是的。因此，現在，它真正專注於 Labcorp 客戶之間的整合步驟。這些是主要的門控項目。有幾項較小的監管文件需要清理，但所有主要障礙都已過去，這就是為什麼我們有相當明確的明確性，但這筆交易將於 9 月底、10 月初完成。

Got it. Okay, thanks for taking my questions.

知道了。好的，謝謝你回答我的問題。

Yale Jen, Laidlaw Company.

耶魯‧詹 (Yale Jen)，萊德勞公司。

My first one is that in terms of closing the Labcorp deals and you mentioned some of the savings. Should that all be realized? Could you give us some sort of quantitative look in terms of how far from that to breakeven and cash breakeven and then we have a follow-up.

我的第一個問題是，在完成 Labcorp 交易方面，您提到了一些節省的費用。這一切都應該實現嗎？您能否給我們一些定量分析，看看距離損益兩平和現金損益平衡有多遠，然後我們進行後續行動。

Yes. So Yale, I think if you step through the numbers and the cost savings plan and the realization of the price increases coupled with the closing of the Labcorp transaction, that will put us to a point where the business is breakeven to slightly profitable. So we only gave the initiatives that will -- we expect or we have in hand that we've -- that we'll initiate upon the closing of the Labcorp transaction. A handful of those are not dependent on the Labcorp transaction closing.

是的。因此，耶魯大學，我認為，如果你逐步了解這些數字和成本節約計劃，並實現價格上漲，再加上 Labcorp 交易的完成，這將使我們的業務達到盈虧平衡至微利的地步。因此，我們只提出了我們預期或我們已經掌握的舉措，這些舉措將在 Labcorp 交易結束時啟動。其中少數不依賴 Labcorp 交易的完成。

Some of the larger ones are as it relates to some of the facility closures. However, we feel highly confident in our ability to deliver the savings that we walked through and the price increases have already been put into effect. So we feel very confident on those numbers being realized in our run rate numbers by the end of the year, which is where we had previously guided to.

一些較大的問題是因為它與一些設施的關閉有關。然而，我們對實現我們所經歷的節省和價格上漲已經生效的能力充滿信心。因此，我們對今年年底在我們的運行率數字中實現這些數字非常有信心，這也是我們先前指導的目標。

Okay, great. That's very helpful and congrats on that. And just one more question on the MDX-2001, which is the first part. Have you guys reviewed what the specific target for the [tetra-factors] on the antibody was against? And the second one actually is on the Pfizer study, which you mentioned about 45 patients. Is that just only the Phase 1a, 1b or that's more? I understand the full study also has the 2a portion, Phase 2a portion. So would you be able to clarify a little bit more on the specific?

好的，太好了。這非常有幫助，對此表示祝賀。還有一個關於 MDX-2001 的問題，這是第一部分。你們有沒有回顧過抗體上的【四因子】的具體標靶是什麼？第二個其實是關於輝瑞公司的研究，你提到了大約 45 名患者。這只是階段 1a、1b 還是更多？據我所知，完整的研究還有 2a 部分、2a 階段部分。那麼能否進一步澄清一下具體情況？

Yes, I can do that. Elias here. Thanks for the question. On the target, I think it's something we have now shared. So I think it's no problem sharing it with you. So it's a quadra-specific antibody that has for tumor targeting has two targets. One is TROP2 and the other one is c-MET. These are the two targets we chose because they're present on about 14 different tumors in oncology. So that's the answer to that.

是的，我可以做到。埃利亞斯在這裡。謝謝你的提問。關於目標，我認為這是我們現在已經分享的。所以我覺得跟大家分享是沒有問題的。因此，它是一種針對腫瘤的四特異性抗體，具有兩個目標。一種是 TROP2，另一種是 c-MET。這是我們選擇的兩個靶點，因為它們存在​​於腫瘤學中大約 14 種不同的腫瘤上。這就是答案。

The size of the study really reflects what you typically do. It's what we do, we call it a basket trial, where you really try different tumor types. We have 11 ones identified, and you try to get signals about the most promising one, which we believe is going to be non-small-cell lung cancer, breast cancer, the solid tumors, pancreatic cancer, we don't know. So that's the first phase of the study.

研究的規模確實反映了您通常所做的事情。這就是我們所做的，我們稱之為籃子試驗，您可以真正嘗試不同的腫瘤類型。我們已經確定了 11 種癌症，你試圖獲得有關最有希望的一種癌症的信號，我們認為這將是非小細胞肺癌、乳腺癌、實體瘤、胰腺癌，我們不知道。這是研究的第一階段。

That's what you call the 1a phase. Once we do that, then we'll narrow down to one or maybe two tumor types, which is contained within the patient volume that we identified for the patient number. And then we'll expand that depending on the results, obviously, the side effects. And so that's clinical development. We need to learn from the basket trial and then decide how we go. And yes, indeed, we have a 1a or 1b phase or go straight to a 2a. That's to be determined by the clinical.

這就是所謂的 1a 階段。一旦我們這樣做了，我們就會縮小到一種或兩種腫瘤類型，這些腫瘤類型包含在我們為患者編號確定的患者體積內。然後我們將根據結果（顯然是副作用）來擴展它。這就是臨床開發。我們需要從籃子試驗中學習，然後決定如何進行。是的，確實，我們有 1a 或 1b 階段，或直接進入 2a 階段。這個要根據臨床來決定。

Okay, great. And maybe just to add one more here, which is, was there any timeline we can start to get some topline or initial readout?

好的，太好了。也許只是在這裡再添加一個，那就是，我們是否有任何時間表可以開始獲得一些頂線或初步讀數？

Okay, so typically, when you do an immuno-oncology trial, you have a first phase, which is safety. So we are escalating the dose. We hope that this will take about six months if everything goes well. And then we'll go into a more efficacy type trial with a cohort of patients, about three patients per dose, ascending dose. So it's hard to predict really because you can't really tell how many patients are going to show up at what time in the six sites.

好的，通常情況下，當你進行免疫腫瘤學試驗時，你有一個第一階段，就是安全性。所以我們正在增加劑量。如果一切順利的話，我們希望這將需要大約六個月的時間。然後我們將對一組患者進行更有效的試驗，每劑約三名患者，劑量遞增。所以很難真正預測，因為你無法真正知道有多少患者會在什麼時間出現在這六個站點。

We have two sites right now, and we have four more; two are imminently going to get activated and two more after that. And so it's really hard to tell, but I think that by 2025, first quarter, we will know if we have a drug that is safe and that can be increasingly dosed, okay? So that's step one.

我們現在有兩個站點，還有四個站點；其中兩個即將被激活，之後還有兩個。所以這真的很難說，但我認為到 2025 年第一季度，我們就會知道我們是否有一種安全的藥物，並且可以增加劑量，好嗎？這是第一步。

And we don't know that at this time. Immuno-oncology is always a -- they're very powerful therapies, but they also have side effects we need to understand and manage. So that's what -- where you would get a readout as to the viability of the program is probably the first half of '25, and then we will know what targets to go after within 2025, depending on results.

目前我們還不知道這一點。免疫腫瘤學始終是一種非常強大的療法，但它們也有我們需要理解和管理的副作用。這就是——你可能會在 25 年上半年獲得有關該計劃可行性的讀數，然後我們將根據結果知道 2025 年要實現的目標。

Okay, great. That's very, very helpful, and again, congrats on the progress.

好的，太好了。這非常非常有幫助，再次恭喜您的進展。

Michael Petusky, Barrington Research.

邁克爾·佩塔斯基，巴靈頓研究中心。

So I guess first question. At the end of this year, it seems like a lot of things are sort of converging sort of going in the right direction. Presumably, you'll have approximately $240 million, just under $240 million coming in from the Labcorp. Obviously, you just did something a couple of weeks ago that gives you additional financial flexibility in terms of the $250 million. You'll have a Lab business that presumably by the end of the year won't be losing much money, if losing money at all. Can you just talk about capital allocation priorities as you sort of end this year and look towards the future? I mean what matters the most as far as the sort of unprecedented financial flexibility you guys will have going forward?

所以我想第一個問題。今年年底，似乎很多事情都在朝著正確的方向發展。據推測，您將獲得約 2.4 億美元，其中來自 Labcorp 的收入略低於 2.4 億美元。顯然，您幾週前剛做了一些事情，為您提供了 2.5 億美元額外的財務靈活性。您將擁有一家實驗室業務，到今年年底，即使有虧損，也不會損失太多資金。在今年即將結束並展望未來之際，您能談談資本配置的優先事項嗎？我的意思是，就你們未來將擁有的前所未有的財務彈性而言，最重要的是什麼？

Elias, do you want to kick us off and I can fill in?

Elias，你想把我們踢掉嗎？

I'll talk about capital allocation in terms of R&D and BioReference. So when we look at BioReference, it's clear that we will need to grow the business once it becomes profitable. And whether or not we need to allocate capital to that is unclear. But it's clearly true that if you look at the market in New York and New Jersey is still very fragmented. And so definitely accelerate the growth in BioReference for increasing revenues.

我將討論研發和 BioReference 方面的資本配置。因此，當我們研究 BioReference 時，很明顯，一旦業務獲利，我們就需要發展業務。我們是否需要為此分配資金仍不清楚。但如果你看看紐約和新澤西的市場，你會發現，它仍然非常分散。因此，肯定會加速 BioReference 的成長以增加收入。

The second is ModeX. I mean ModeX has a rich portfolio, and we're going to do two things. We're going to explore partnerships as we've done with Merck and BARDA and others are in the hopper. But because we have some capital, we can get better economics with a partner than we do without capital being available.

第二個是ModeX。我的意思是，ModeX 擁有豐富的產品組合，我們將做兩件事。我們將探索合作夥伴關係，就像我們與默克（Merck）和 BARDA 以及其他公司一樣。但因為我們有一些資本，所以與合作夥伴合作可以比沒有資本時獲得更好的經濟效益。

So for example, if you look at certain assets, you get a much higher inflection points in value if you can progress the program to proof-of-concept. And that may be actually the best way to achieve greater economics for the portfolio. So it's going to be depending upon results, obviously, depending upon partnerships because we think that we're not going to take the risk, I believe, unless we have exceptional results of allocating the capital to completely carry the development program all the way to approval.

例如，如果您查看某些資產，如果您可以將程序推進到概念驗證階段，您將獲得更高的價值轉折點。這實際上可能是實現投資組合更大經濟效益的最佳方式。因此，顯然，這將取決於結果，取決於合作夥伴關係，因為我相信，我們認為我們不會冒險，除非我們在分配資本方面取得了非凡的成果，以完全將發展計劃一路推進到贊同。

I don't think we have enough of that, and it would not be hedging, it will not be reasonable to do that unless you have outstanding exceptional results. But the best path forward right now is to really try to get a bigger share of the economics of our portfolio by very judicious and very limited capital allocation is you're not talking about hundreds of millions of dollars. But if you can advance the program to park a feasibility stage, then it really increases in value for potential strategic partners or other moves. I don't know if I'm making myself clear.

我不認為我們有足夠的這些，而且這不會是對沖，除非你有出色的特殊成果，否則這樣做是不合理的。但目前最好的前進道路是，透過非常明智和非常有限的資本配置，真正嘗試在我們的投資組合中獲得更大的經濟份額，而不是數億美元。但如果你可以推進該計劃以達到可行性階段，那麼它對於潛在戰略合作夥伴或其他舉措的價值確實會增加。我不知道我是否表達清楚了。

Now in terms of the other uses of capital, I'll let Adam comment on that.

現在就資本的其他用途而言，我將讓 Adam 對此進行評論。

Yes. So Mike, I think the other components, we announced $100 million share buyback. I think we've talked a little bit about potentially taking out portions of the convertible notes that are outstanding as well. But I think we're going to be allocating that capital based on the market conditions for both of those items will provide longer-term guidance as it relates to the R&D budget and other items in upcoming calls. But we're sitting here today, working through all of those different pulls and pushes on creating that shareholder value and are committing significant dollars already to returning capital to shareholders through those two repurchase programs.

是的。麥克，我認為其他組成部分，我們宣布了 1 億美元的股票回購。我想我們已經討論過可能取出部分未償還的可轉換票據的問題。但我認為我們將根據這兩個項目的市場狀況分配資本，這將提供長期指導，因為它與研發預算和即將召開的電話會議中的其他項目有關。但我們今天坐在這裡，透過所有這些不同的拉動和推動來創造股東價值，並已投入大量資金透過這兩個回購計劃向股東返還資本。

Is there -- Adam, if I could ask, is there any sort of targeted time frame on sort of achieving or executing most of the share repurchase or what -- and whatever notes you might decide to repurchase?

亞當，如果我可以問的話，是否有某種目標時間框架來實現或執行大部分股票回購或其他什麼，以及您可能決定回購的任何票據？

No, we haven't set a timetable to it, like no.

不，我們還沒有設定時間表，就像沒有一樣。

And then I guess on Rayaldee, you guys have been, maybe for the last few quarters sort of suggesting, hey, we think we've got some data that could be interesting to nephrologists in terms of the efficacy for these CKD patients. It hasn't really shown up in the numbers. I think we're about flat year-over-year for the first half versus first half of '23. I mean, is there anything anecdotal that you're getting back from sales in terms of this data that you guys are trying to argue, hey, this should matter to you guys? I mean, is there anything to say on that, that would be encouraging or does it just, or is this missionary and it takes a while? Thanks.

然後我想在 Rayaldee 上，你們可能在過去的幾個季度裡一直在暗示，嘿，我們認為我們已經獲得了一些腎臟病學家對這些 CKD 患者的療效可能感興趣的數據。它並沒有真正體現在數字中。我認為上半年與 23 年上半年相比，年比持平。我的意思是，根據你們試圖爭辯的數據，你們從銷售中得到了什麼軼事，嘿，這對你們來說應該很重要嗎？我的意思是，對此有什麼可說的，這會是令人鼓舞的還是只是這樣，或者這是傳教士，這需要一段時間？謝謝。

I don't know if Charles is online, Dr. Bishop.

我不知道查爾斯是否在線，畢夏普博士。

He is not.

他不是。

Okay. So let me take it. So when you look at the issue of growth for Rayaldee, the number one request from nephrologists is does it have a good outcome impact. And that's the sign as delaying dialysis and delaying the onset of total renal failure.

好的。那麼就讓我來吧。因此，當您考慮 Rayaldee 的生長問題時，腎臟科醫師的首要要求是它是否會對結果產生良好的影響。這就是延遲透析和延遲完全腎衰竭發生的跡象。

Now one of the factors that drives that is when your hyperparathyroid is producing a large amount of hormone because the kidney itself is no longer producing vitamin D. And the only drug that really has been shown to raise to the -- to be able to raise the levels of vitamin D to the levels where the parathyroid hormone goes down, is Rayaldee. We've shown that before.

現在，驅動這一現象的因素之一是，當您的副甲狀腺功能亢進症產生大量激素時，因為腎臟本身不再產生維生素 D。將維生素D 的水平降低到副甲狀腺激素下降的水平。我們之前已經展示過這一點。

So it's not new. However, what we haven't shown and that's we -- this is where we are hoping that the nephrology world, which has been supported, would like to -- what we would like to show is, in fact, that there is an impact. Now there's -- there're publications that are coming out that Dr. Bishop is pushing. And obviously, the guidelines will have to be changed. So that takes time.

所以這並不新鮮。然而，我們還沒有展示什麼——這就是我們希望得到支持的腎臟病學界想要展示的——事實上，我們想要展示的是，有一種影響。現在，畢曉普博士正在推動出版一些出版物。顯然，指導方針必須改變。所以需要時間。

As you know, medical practice is not something you can change overnight. But we're optimistic. Now is this going to be a short-term big bang for Rayaldee? I don't think so, honestly. I think it's going to take time to sink in into the practice world.

如你所知，醫療實踐不是一朝一夕就能改變的。但我們很樂觀。現在這對 Rayaldee 來說會是一個短期的大爆炸嗎？老實說，我不這麼認為。我認為融入實踐世界需要時間。

Can I ask one last question that sort of links both of the questions I've already asked so far. Is there any rationale for trying to buy maybe a commercial product that could be marketed to nephrologists just to give the Rayaldee sales team just another arrow in the quiver. I mean would something like that make sense? Or is there just nothing out there that really would fit like that in terms of potentially looking at that as a source of capital allocation priority?

我可以問最後一個問題，該問題與我到目前為止已經問過的兩個問題有關嗎？嘗試購買一種可以向腎臟病專家推銷的商業產品是否有任何理由，只是為了給 Rayaldee 銷售團隊又一箭。我的意思是這樣的事情有意義嗎？或者是否沒有任何東西真正適合將其視為資本配置優先權的來源？

I'll answer that. And your question is a good one. It's perfectly rational, and I will tell you that we have been looking for opportunities of that sort. And if you come across one, please let us know.

我會回答這個問題。你的問題問得很好。這是完全理性的，我會告訴你，我們一直在尋找這類機會。如果您遇到這樣的情況，請告訴我們。

Fair enough. All right. Thank you.

很公平。好的。謝謝。

And ladies and gentlemen, this concludes today's question-and-answer session. I would like to turn the conference back over to Dr. Frost for any concluding remarks.

女士們、先生們，今天的問答環節到此結束。我想將會議轉回弗羅斯特博士進行總結發言。

Well, I just want to thank everybody for your participation and for your good questions, and we look forward to meeting with you again after our next quarter's results. Thank you, and have a good evening.

好吧，我只想感謝大家的參與和提出的好問題，我們期待在下一季的業績公佈後再次與您會面。謝謝您，祝您晚上愉快。

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

謝謝。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。