OPKO Health Inc (OPK) 2023 Q4 法說會逐字稿

Good day, and welcome to the OPKO Health fourth-quarter 2023 financial results conference call. (Operator Instructions) Please note this event is being recorded.

美好的一天，歡迎參加 OPKO Health 2023 年第四季財務業績電話會議。（操作員說明）請注意此事件正在被記錄。

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

我現在想把會議交給伊馮·布里格斯。請繼續。

Thank you, operator. 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 fourth quarter of 2023. I'd like to remind you that any statements made during this call by management other than statements of historical fact will be considered forward-looking, and as such, will be subject to risks and uncertainties that could materially affect the company's expected results.

謝謝你，接線生。午安.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 2023 年第四季的財務表現。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，將面臨可能對公司預期結果產生重大影響的風險和不確定性。

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 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, February 27, 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.

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。本次電話會議包含時效性訊息，僅截至直播日期（2024 年 2 月 27 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 for 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 OPKO's Pharmaceutical business as well as BioReference Health; after that, Adam Logal, OPKO's CFO, will review the company's fourth-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格式。董事長兼執行長 Phillip Frost 博士將宣布電話會議開幕；隨後，副主席兼總裁 Elias Zerhouni 博士將概述 OPKO 的製藥業務以及 BioReference Health 業務；之後，OPKO財務長Adam Logal將審查公司第四季財務業績；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. 2023 was a year of significant achievement for OPKO, and we expect continued progress in 2024. In 2023, NGENLA, our long-acting growth hormone therapy, was approved by the FDA for sale in the US, the largest growth hormone market in the world. Pfizer, our global commercial partner, has now launched NGENLA in over 40 markets worldwide, and we're optimistic about Pfizer's ability to convert users to the weekly injection from the daily to further penetrate this growing $5.5 billion market.

下午好，感謝您今天加入我們。 2023 年是 OPKO 取得重大成就的一年，我們預計 2024 年將繼續取得進展。2023年，我們的長效生長激素療法NGENLA獲得FDA批准在全球最大的生長激素市場美國銷售。我們的全球商業合作夥伴輝瑞現已在全球 40 多個市場推出 NGENLA，我們對輝瑞將用戶從每日註射轉變為每週注射的能力感到樂觀，以進一步滲透這個不斷增長的 55 億美元市場。

ModeX made great strides last year, in particular, in executing its strategy to secure important collaborations to advance its multispecific biologics platform into the clinic. These collaborations provide nondilutive funding to advance our unique pipeline to commercial realization. Specifically, last March, we announced an exclusive worldwide license and collaboration agreement with Merck to develop ModeX's nanoparticle vaccine candidate against Epstein-Barr virus. We received a sizable up-front payment and are eligible for milestone and royalty payments.

ModeX 去年取得了巨大進步，特別是在執行策略以確保重要合作以將其多特異性生物製劑平台推進臨床方面。這些合作提供非稀釋性資金，以推動我們獨特的管道商業化。具體來說，去年 3 月，我們宣布與默克簽訂全球獨家授權和合作協議，開發 ModeX 的 Epstein-Barr 病毒的奈米顆粒候選疫苗。我們收到了一大筆預付款，並且有資格獲得里程碑付款和特許權使用費。

In September, ModeX was awarded a contract from the Biomedical Advanced Research and Development Authority, known as BARDA, to develop novel multispecific antibodies against viruses that cause infectious diseases deemed to be public health threats. The BARDA contract included an initial payment to develop multispecific antibodies to treat and prevent COVID-19, and additional funding may be available to develop multispecific antibodies targeting other viral pathogens such as influenza. Elias will provide more detail on those programs.

9 月，ModeX 獲得了生物醫學高級研究與開發局（BARDA）的一份合同，開發新型多特異性抗體，以對抗導致公共衛生威脅的傳染病的病毒。BARDA 合約包括開發多特異性抗體以治療和預防 COVID-19 的首期付款，並可能提供額外資金來開發針對其他病毒病原體（例如流感）的多特異性抗體。埃利亞斯將提供有關這些計劃的更多細節。

Sales of RAYALDEE, our drug to treat chronic kidney disease patients with elevated parathyroid hormone and low vitamin D levels, grew 13% last year, and we're expecting further progress this year. We're gathering data, which indicate that RAYALDEE may slow chronic kidney disease progression.

RAYALDEE 是我們治療副甲狀腺素升高和維生素 D 水平低的慢性腎病患者的藥物，去年的銷售額增加了 13%，我們預計今年將取得進一步進展。我們正在收集數據，這些數據表明 RAYALDEE 可能會減緩緩性腎病變的進展。

Some of you have been asking about my long-time enthusiasm for our once-weekly oxyntomodulin product to treat Type 2 diabetes and obesity. You'll remember that we had completed a successful Phase II trial achieving significant weight loss, lowering of serum cholesterol and triglycerides and lowered A1C levels. We delayed a Phase III trial when other products appeared, which provided greater weight loss.

你們中的一些人一直在問我長期以來對我們每週一次的胃泌酸調節素產品治療 2 型糖尿病和肥胖症的熱情。您會記得我們已經成功完成了一項 II 期試驗，實現了顯著的體重減輕、血清膽固醇和甘油三酯的降低以及 A1C 水平的降低。當其他產品出現時，我們推遲了第三階段試驗，這提供了更大的減肥效果。

Noting the great commercial success of these products, we decided to have a closer look at ours. The polyethylene glycol, PEG, added to our base peptide to increase its half-life is large and bulky and increased the viscosity of the injection, which limited the maximum dose administered, which is related to the amount of weight loss. We have now found a substitute for PEG, which makes our molecule size similar to those on the market. With guarded optimism, we're in early stages of preclinical evaluation of this product.

注意到這些產品取得了巨大的商業成功，我們決定仔細研究我們的產品。添加到我們的基礎勝肽中以增加其半衰期的聚乙二醇（PEG）體積大且體積大，並且增加了注射劑的黏度，這限制了施用的最大劑量，這與體重減輕的量有關。我們現在已經找到了 PEG 的替代品，這使得我們的分子大小與市場上的類似。懷著謹慎的樂觀態度，我們正處於該產品臨床前評估的早期階段。

Switching to our international business, OPKO Iberoamerica, FineTech, and EirGen are all doing well. Turning to BioReference Health. Our team has worked hard to improve our cost structure and enhance revenue. In addition to our expense reduction efforts, BioReference has been aiming to drive growth in higher value segments with new tests, larger customers and better insurance reimbursement. We are laser-focused on returning this segment to profitability in the near term. And again, Elias will provide more detail.

轉向我們的國際業務，OPKO Iberoamerica、FineTech 和 EirGen 都表現良好。轉向生物參考健康。我們的團隊努力改善成本結構並增加收入。除了努力削減開支外，BioReference 還致力於透過新的測試、更大的客戶和更好的保險報銷來推動更高價值領域的成長。我們專注於在短期內使該部門恢復盈利。埃利亞斯將再次提供更多細節。

With that overview, I'll turn it over to Elias.

有了這個概述，我將把它交給 Elias。

segments of OPKO Health. NGENLA launches in all major global markets, as mentioned by Phil, is progressing well, and we believe this drug is well positioned for significant growth. This next-generation long-acting therapy's administered once a week and not daily and assisted easing the burden, especially for the pediatric market, and increases medication adherence. NGENLA annual growth is anticipated to be in excess of 12%.

OPKO Health 的各個部門。正如 Phil 所提到的，NGENLA 在全球所有主要市場的上市進展順利，我們相信該藥物處於顯著增長的有利位置。這種下一代長效療法每週給藥一次，而不是每天給藥，有助於減輕負擔，特別是對於兒科市場，並提高藥物依從性。NGENLA 的年增長率預計將超過 12%。

But as part of our partnership with Pfizer, OPKO's (inaudible) achieve additional $100 million in milestone payments associated with approvals for an adult indication for growth hormone deficiency and additional pediatric indications. These are global registration strategies underway for the adult application and other pediatric indications, which are currently in Phase III clinical trials.

但作為我們與輝瑞合作的一部分，OPKO（聽不清楚）獲得了額外 1 億美元的里程碑付款，這些付款與批准成人生長激素缺乏症適應症和其他兒科適應症有關。這些是針對成人應用和其他兒科適應症的全球註冊策略，目前正在進行 III 期臨床試驗。

Phil also mentioned our success last year in securing collaborations for ModeX Therapeutics with BARDA and Merck. Most recently, with BARDA, we secured an initial $59 million grant to fund R&D and clinical evaluation through a Phase I study of our multispecific antibodies against known variants of SARS-CoV-2 for the treatment as well as prevention of COVID-19, which remains a particular [drug], especially for immunocompromised patients.

Phil 也提到我們去年在 ModeX Therapeutics 與 BARDA 和默克公司的合作方面取得了成功。最近，我們與BARDA 合作，透過針對已知SARS-CoV-2 變異體的多特異性抗體的I 期研究，獲得了5,900 萬美元的初始撥款，用於資助研發和臨床評估，用於治療和預防COVID-19，仍然是一種特殊的[藥物]，特別是對於免疫功能低下的患者。

Additional funding of up to $109 million based upon the achievement of certain milestones in the first phase may be available from BARDA to develop more multispecific antibodies targeting other viral pathogens such as influenza. And as part of the research program, gene-based delivery methods for the multispecific antibodies will be developed using mRNA or DNA vectors to supplement the body's natural protein production processes and hopefully provide BARDA with a platform that can be used very quickly for any emerging [platforms].

基於第一階段某些里程碑的實現，BARDA 可能會提供高達 1.09 億美元的額外資金，用於開發更多針對流感等其他病毒病原體的多特異性抗體。作為研究計劃的一部分，將使用 mRNA 或 DNA 載體開發基於基因的多特異性抗體遞送方法，以補充人體的天然蛋白質生產過程，並希望為 BARDA 提供一個可以快速用於任何新興領域的平台。[平台]。

In addition, we announced the collaboration with Merck to develop MDX-2201, which is our Epstein-Barr virus multivalent nanoparticle vaccine. We received a $50 million up-front payment for the license of this vaccine, with a potential $872.5 million in development and commercial milestones and scaled royalties on global sales, ranging from single-digit to double-digit percentages. This program truly leverages ModeX's nanoparticle-based vaccine platform, which enables simultaneous immunization against several major EBV proteins, in this case, four major EBV proteins, but the platform itself has the potential to, in fact, address multiple antigens against multiple viral diseases.

此外，我們也宣布與默克合作開發 MDX-2201，這是我們的 Epstein-Barr 病毒多價奈米顆粒疫苗。我們收到了該疫苗許可的 5000 萬美元預付款，潛在的開發和商業里程碑費用為 8.725 億美元，全球銷售特許權使用費比例從個位數到兩位數不等。該計劃真正利用了ModeX 基於奈米顆粒的疫苗平台，該平台能夠同時針對幾種主要EBV 蛋白（在本例中為四種主要EBV 蛋白）進行免疫，但該平臺本身實際上有潛力針對多種病毒性疾病的多種抗原。

The market opportunity here is quite large, as the Epstein-Barr virus affects up to 95% of the global adult population during their lifetime. Moreover, there are over 260,000 cancer cases annually caused by EBV along with an association between multiple sclerosis and this virus. We're working with Merck on IND clinical studies, and we expect Phase I clinical trials to start later this year.

這裡的市場機會相當大，因為 Epstein-Barr 病毒影響著全球多達 95% 的成年人。此外，每年有超過 26 萬例由 EBV 引起的癌症病例以及多發性硬化症與該病毒之間的關聯。我們正在與默克公司合作進行 IND 臨床研究，預計 I 期臨床試驗將於今年稍後開始。

To round out our ModeX pipeline, we have partnered with the NIH to develop an antiviral multispecific antibody focused on the treatment and prevention of HIV. We've had success with our first-generation candidate in the Phase I trial, and we are moving forward with a more potent next-generation tetraspecific antibody versus the previous trispecific one. We believe there is an unmet need for a therapy that can provide long-acting protection and treatment for patients who require options beyond small molecule-based therapies.

為了完善我們的 ModeX 管道，我們與 NIH 合作開發了一種抗病毒多特異性抗體，專注於治療和預防 HIV。我們的第一代候選抗體在第一階段試驗中取得了成功，我們正在開發比先前的三特異性抗體更有效的下一代四特異性抗體。我們相信，對於一種能夠為需要小分子療法以外的選擇的患者提供長效保護和治療的療法的需求尚未得到滿足。

And lastly, our immuno-oncology programs. Our focus on hard-to-treat solid tumors, as well as liquid tumors such as leukemias and lymphomas. Our multispecific antibody candidates can simultaneously target several tumor antigens and enable better control of immune system activation. Our tetraspecific laser program to treat solid tumors is expected to enter the clinic the first half of this year.

最後是我們的免疫腫瘤學計畫。我們專注於難以治療的實體腫瘤以及白血病和淋巴瘤等液體腫瘤。我們的多特異性候選抗體可以同時靶向多種腫瘤抗原，並且能夠更好地控制免疫系統的活化。我們治療實體瘤的四特異性雷射計畫預計將於今年上半年進入臨床。

Now I'd like to turn to a review of our diagnostics segment, BioReference Health. 2023 was a transition year for our diagnostics division as we get closer to turning the corner to profitability. As you know, we implemented our REACH initiatives to reduce costs, improve efficiency and enhance productivity. For example, we've reduced our head count by 8% or 252 head count in 2023. In parallel, we're driving growth in various testing segments, including our higher-value specialty segments like oncology, women's health and in urology, primarily through our proprietary 4Kscore test.

現在我想回顧一下我們的診斷部門 BioReference Health。 2023 年是我們診斷部門的過渡年，我們離扭虧為盈越來越近了。如您所知，我們實施 REACH 措施是為了降低成本、提高效率和生產力。例如，我們在 2023 年將員工人數減少了 8%，即 252 人。同時，我們主要透過我們專有的 4Kscore 測試來推動各個測試領域的成長，包括腫瘤學、女性健康和泌尿學等高價值專業領域。

The 4Kscore test volume has continued to perform, and we expect these volumes to continue as the test was included in the 2023 American Urology Association and the NCNN guidelines for early detection of prostate cancer and for follow-up after PSA screening for initial and repeat biopsy risk stratification. In addition, we expect that the recent expansion of insurance coverage will continue to bolster levels this year.

4Kscore 測試量繼續進行，我們預計這些量將繼續進行，因為該測試已被納入 2023 年美國泌尿學協會和 NCNN 指南，用於前列腺癌的早期檢測以及初始和重複活檢 PSA 篩檢後的隨訪風險分層。此外，我們預計近期保險覆蓋率的擴大將繼續提升今年的水準。

GenPath continued to launch innovative testing, including an expanded hematologic malignancy panel and introducing several new tests in the market that will sustain growth of the GenPath oncology products.

GenPath 持續推出創新測試，包括擴大血液惡性腫瘤檢測組，並在市場上推出多項新測試，以維持 GenPath 腫瘤產品的成長。

Other advances have been made over the 2023 year. For example, we have signed over 300 new accounts in the fourth quarter of 2023 with over 40,000 accessions, additional accessions. And we've also signed major oncology groups like the Virginia Oncology group with 90 oncologists which is a component of US Oncology that started in November.

2023 年也取得了其他進展。例如，我們在 2023 年第四季簽署了 300 多個新帳戶，新增加入量超過 40,000 個。我們還與主要腫瘤學團體簽署了協議，例如擁有 90 名腫瘤學家的弗吉尼亞腫瘤學團體，該團體是 11 月啟動的美國腫瘤學的組成部分。

So in summary, BioReference Health made great progress last year, and we expect to continue to build on these achievements in 2024. We narrowed our operating loss sequentially. And through both expense reduction and revenue growth, we continue to feel confident that these efforts will further improve financial metrics and return this segment to profitability in the next few years.

總而言之，BioReference Health 去年取得了巨大進步，我們預計 2024 年將繼續在這些成就的基礎上再接再厲。我們的經營虧損連續縮小。透過減少開支和增加收入，我們仍然相信這些努力將進一步改善財務指標，並在未來幾年內使該部門恢復盈利。

I will now turn the call over to Adam Logal to discuss our fourth-quarter financial results. Adam?

我現在將電話轉給 Adam Logal，討論我們第四季的財務表現。亞當？

Thank you, Elias. Starting with our pharmaceuticals segment. Revenue increased to $57.7 million for the fourth quarter of 2023 from $46 million for the comparable period of 2022. Revenue from products, including our international pharmaceutical businesses and RAYALDEE, increased by $5.1 million, reflecting from improvements in the number of prescriptions and in overall net price.

謝謝你，埃利亞斯。從我們的製藥部門開始。2023 年第四季的營收從 2022 年同期的 4,600 萬美元增至 5,770 萬美元。產品收入（包括我們的國際製藥業務和 RAYALDEE）增加了 510 萬美元，反映了處方數量和整體淨價的改善。

Further, revenue increased as a result of gross profit share payments from Pfizer due to the global launch of NGENLA, resulting in $12.2 million of revenue during the quarter. The fourth-quarter revenue includes a catch-up payment for the US market related to the third quarter of $3.1 million.

此外，由於 NGENLA 在全球推出，輝瑞支付了毛利份額，導致收入增加，本季收入達到 1,220 萬美元。第四季營收包括與第三季相關的美國市場310萬美元的追加付款。

As I mentioned last quarter, the US launch occurred mid-August, and Pfizer was delayed in reporting our gross profit share amounts. And as a result, none were included in our third quarter results.

正如我上季度提到的，美國的上市發生在 8 月中旬，輝瑞推遲了報告我們的毛利份額金額。因此，我們的第三季業績中沒有包含任何內容。

Costs and expenses were $73.8 million for the fourth quarter of 2023 compared to $68 million for the 2022 period. Research and development expenses for the fourth quarter of '23 were $18.7 million compared to $16.6 million for the comparable period of 2022. This increase reflects activities for our ModeX development programs, partially offset by decreased spending on NGENLA as well as an R&D tax credit for our Irish activities.

2023 年第四季的成本和支出為 7,380 萬美元，而 2022 年第四季的成本和支出為 6,800 萬美元。2023 年第四季的研發費用為 1,870 萬美元，而 2022 年同期為 1,660 萬美元。這一增長反映了我們的 ModeX 開發計劃的活動，部分被 NGENLA 支出的減少以及我們愛爾蘭活動的研發稅收抵免所抵消。

The resulting operating loss for the quarter ended December 31, 2023, was $16 million, a $6 million improvement from the operating loss of $22 million for the fourth quarter of 2022. Amortization expenses related to intangible assets were $16.4 million and $16.5 million for the 2023 and 2022 fourth quarters, respectively.

截至 2023 年 12 月 31 日的季度營運虧損為 1,600 萬美元，比 2022 年第四季的營運虧損 2,200 萬美元減少了 600 萬美元。2023 年及 2022 年第四季與無形資產相關的攤銷費用分別為 1,640 萬美元及 1,650 萬美元。

Moving to our diagnostics segment. We reported revenue for Q4 2023 of $124.2 million compared with $139.4 million for the 2022 period. This decline primarily reflects lower COVID testing of $7.1 million as well as a change to our estimated collections of $8.1 million, partially offset by increased testing volumes.

轉向我們的診斷部分。我們報告 2023 年第四季的營收為 1.242 億美元，而 2022 年同期的營收為 1.394 億美元。這一下降主要反映了新冠病毒檢測減少了 710 萬美元，以及我們估計的收集金額發生了 810 萬美元的變化，但部分被檢測量的增加所抵消。

Costs and expenses increased to $166.4 million for the fourth quarter of 2023 from $162.5 million for the 2022 period. Operating loss for our diagnostics segment included a change in estimated collections as well as approximately $4.7 million of nonrecurring costs related to employee severance and retention programs associated with our efforts to return to profitability.

2023 年第四季的成本和支出從 2022 年期間的 1.625 億美元增至 1.664 億美元。我們診斷部門的營運虧損包括預計收款額的變化，以及與員工遣散費和與我們恢復盈利能力相關的保留計劃相關的約 470 萬美元的非經常性成本。

Depreciation and amortization expense were $8.1 million and $8.7 million for the 2023 and 2022 periods, respectively.

2023 年和 2022 年期間的折舊和攤提費用分別為 810 萬美元和 870 萬美元。

Turning to our consolidated financial results. For the fourth quarter of 2023, we reported an operating loss of $69.1 million compared to an operating loss of $55.3 million for the 2022 quarter. Net loss for the fourth quarter of 2023 was $66.5 million or $0.09 per share, which compares with a net loss of $85.2 million or $0.11 per share for the 2022 quarter, reflecting lower noncash mark-to-market losses related to our investment in GeneDx.

轉向我們的綜合財務表現。2023 年第四季度，我們報告的營運虧損為 6,910 萬美元，而 2022 年第四季的營運虧損為 5,530 萬美元。2023 年第四季的淨虧損為6,650 萬美元，即每股0.09 美元，而2022 年季度的淨虧損為8,520 萬美元，即每股0.11 美元，反映出與我們投資GeneDx 相關的非現金按市值計價虧損較低。

I'd like to briefly comment on our balance sheet and the recently completed refinancing of our convertible debt. On December 31, we had two convertible debt issuances that were set to mature in early 2025. Our 4.5% notes, which were held by a number of institutions, and our 5% notes, which were primarily held by Dr. Frost, Dr. Hsiao and a long-term investor of OPKO.

我想簡要評論一下我們的資產負債表和最近完成的可轉換債務再融資。12 月 31 日，我們發行了兩筆可轉換債券，預計 2025 年初到期。我們的4.5%票據由多家機構持有，我們的5%票據主要由Frost博士、Hsiao博士和OPKO的長期投資者持有。

In consultation with our advisers at JP Morgan, we chose to issue new five-year notes, reducing our coupon interest rate to 3.75% and took advantage of the strong demand from institutional investors to raise a total of $230 million. We used the proceeds to buy back the outstanding 4.5% notes and the 55 million shares of our common stock, and we added approximately $25 million in cash to our balance sheet. Our 5% note holders exchanged their principal and accrued interest of approximately $71.1 million into notes with identical financial terms as the 3.75% note holders.

在與摩根大通顧問協商後，我們選擇發行新的五年票據，將票面利率降低至 3.75%，並利用機構投資者的強勁需求，籌集了總計 2.3 億美元的資金。我們用所得收益回購了已發行的 4.5% 票據和 5,500 萬股普通股，並在資產負債表上增加了約 2,500 萬美元的現金。我們的 5% 票據持有人將其本金和約 7,110 萬美元的應計利息交換為與 3.75% 票據持有人財務條款相同的票據。

This refinancing strengthened our balance sheet, reduced the number of shares outstanding and provided the company with additional cash to fund our ongoing development activities. The offering was oversubscribed and brought in an impressive group of new prominent investors to OPKO.

這次再融資增強了我們的資產負債表，減少了流通股數量，並為公司提供了額外的現金來資助我們正在進行的開發活動。此次發行獲得超額認購，並為 OPKO 帶來了一群令人印象深刻的新的知名投資者。

During 2024, we anticipate receipt of additional nondilutive cash payments under our existing collaborations with Merck, BARDA and other potential transactions as the year progresses.

2024 年，隨著時間的推移，我們預計將根據與默克、BARDA 的現有合作以及其他潛在交易收到額外的非稀釋性現金付款。

As we look ahead, we're providing the following financial guidance with the following assumptions. For our pharmaceuticals segment, there are a number of factors that impact our gross profit share payments from Pfizer, including revenue from product sales of GENOTROPIN and NGENLA. Global sales of GENOTROPIN for 2023 as reported by Pfizer were $539 million. Pfizer has not separately reported sales of NGENLA. However, we have observed consistent prescription growth globally for NGENLA as reported by IQVIA and Symphony.

展望未來，我們將根據以下假設提供以下財務指導。對於我們的製藥部門，有許多因素影響我們從輝瑞支付的毛利份額，包括 GENOTROPIN 和 NGENLA 產品銷售的收入。根據輝瑞報告，2023 年 GENOTROPIN 的全球銷售額為 5.39 億美元。輝瑞尚未單獨報告 NGENLA 的銷售額。然而，根據 IQVIA 和 Symphony 的報告，我們觀察到 NGENLA 的全球處方量持續成長。

As such, for the full year, we estimate our gross profit share will be between $40 million and $50 million, although we anticipate that a number of scenarios may impact sales of GENOTROPIN and NGENLA globally.

因此，我們預計全年的毛利份額將在 4,000 萬至 5,000 萬美元之間，儘管我們預計許多情況可能會影響 GENOTROPIN 和 NGENLA 的全球銷售。

We assume a stable foreign exchange rate for our ex US Pharmaceutical businesses, which will allow for continued and profitable growth.

我們假設我們的前美國製藥業務的外匯匯率穩定，這將實現持續的獲利成長。

R&D expenses for the first quarter of 2024 will reflect higher activities related to our ModeX programs, including CMC and efforts related to the initiation of our first immuno-oncology clinical trial. Those increased activities will be partially funded through our BARDA agreement and partially offset by lower R&D costs related to the wind down of our clinical operations for the ongoing open-label pediatric extension study for NGENLA, which we expect to substantially complete by the end of the first quarter.

2024 年第一季的研發費用將反映與我們的 ModeX 計畫相關的較高活動，包括 CMC 以及與啟動我們的第一個免疫腫瘤學臨床試驗相關的工作。這些增加的活動將部分透過我們的BARDA 協議提供資金，部分由與我們正在進行的NGENLA 開放標籤兒科擴展研究的臨床操作逐步結束相關的研發成本降低所抵消，我們預計該研究將在今年年底前基本完成。第一季。

For our diagnostics segment, as Elias outlined, we are diligently working to align the business to achieve cash flow breakeven by the middle of 2024 and profitability by the end of the year. This work includes consolidating our geographic footprint and rationalizing our test offerings. As a result, we expect our client mix to improve and cost structure to appropriately support our go-forward strategy.

對於我們的診斷部門，正如 Elias 所概述的那樣，我們正在努力調整業務，以在 2024 年中期實現現金流收支平衡，並在年底實現盈利。這項工作包括鞏固我們的地理足跡並合理化我們的測試產品。因此，我們預計我們的客戶結構和成本結構將得到改善，以適當地支持我們的前進策略。

During this transition phase, we expect consistent core testing volumes with a slight increase in the average per patient collection amount due to our revenue cycle management initiatives, partially offset by volume impact due to several weather events that occurred during the first quarter already.

在此過渡階段，我們預計核心檢測量將保持一致，由於我們的收入週期管理舉措，每位患者的平均收集量將略有增加，部分抵消了第一季已發生的幾次天氣事件造成的檢測量影響。

Before considering any nonrecurring costs that may result from our restructuring activities, we expect our costs and expenses to decline sequentially by $7 million to approximately $159 million.

在考慮重組活動可能產生的任何非經常性成本之前，我們預計我們的成本和費用將環比下降 700 萬美元，至約 1.59 億美元。

As a result, we expect the following for the first quarter of 2024: total revenues between $180 million and $185 million; revenue from services between $126 million and $130 million; revenue from product sales between $36 million and $40 million; and other revenue between $14 million and $18 million, inclusive of the estimated Pfizer gross profit share payments between $9 million and $11 million.

因此，我們預期 2024 年第一季的業績如下：總營收在 1.8 億美元至 1.85 億美元之間；服務收入在 1.26 億至 1.3 億美元之間；產品銷售收入在 3,600 萬至 4,000 萬美元之間；以及其他收入在 1400 萬美元到 1800 萬美元之間，其中包括估計的輝瑞毛利潤份額付款在 900 萬美元到 1100 萬美元之間。

We expect first-quarter costs and expenses to be between $235 million and $245 million, including R&D expense between $20 million and $29 million, dependent on the timing for certain CMC activities for our ModeX programs and depreciation and amortization expense of $26 million.

我們預計第一季的成本和費用將在2.35 億美元至2.45 億美元之間，其中研發費用在2000 萬美元至2900 萬美元之間，具體取決於我們ModeX 計劃的某些CMC 活動的時間安排以及2600 萬美元的折舊和攤提費用。

That concludes our prepared remarks. Thank you for your attention. Operator, let's open the call for questions.

我們準備好的演講到此結束。感謝您的關注。接線員，讓我們開始提問。

(Operator Instructions) Jeffrey Cohen, Ladenburg.

（操作員說明）Jeffrey Cohen，拉登堡。

Well, good afternoon, everyone, and thanks for taking our questions. I guess, first, Adam, could you just recap on your financials with regard to the 4.5% and 5% instruments out there? So currently then, share count is down toward approximately 700. What would be appropriate cash and debt levels whereupon we're estimating pro forma?

嗯，大家下午好，感謝您提出我們的問題。我想，首先，Adam，您能否回顧一下有關 4.5% 和 5% 工具的財務狀況？目前，股票數量已減少至 700 左右。我們預估的適當現金和債務水準是多少？

Yes. So we ended the year with $95 million in cash. So if you pro forma in the additional $25 million, that would put us right at about $120 million in cash on a pro forma basis. The total convertible notes were just over $300 million, so just right at $300 million in principal. And you've got the share count right, the 700.

是的。因此，我們在年底擁有 9500 萬美元現金。因此，如果您預計額外增加 2500 萬美元，那麼我們預計將擁有約 1.2 億美元的現金。可轉換票據總額剛超過 3 億美元，因此本金正好為 3 億美元。你的股票數是正確的，700。

Okay. Perfect. Got it. Could one of you discuss a little bit about the press release with regard to the Alibaba global platform in China and talk about perhaps some of the products that you're planning on offering and what should we expect as far as the status during '24?

好的。完美的。知道了。你們中的一位能否討論一下有關中國阿里巴巴全球平台的新聞稿，並談談你們計劃提供的一些產品以及我們對“24 小時”期間的狀況應該有何期待？

The products involved are made by our Spanish company and are primarily nutritional products for animals, for which there appears to be a large market in China, and it is just beginning. So there's not much else to say about it.

涉及的產品是我們西班牙公司生產的，主要是動物營養產品，在中國似乎有很大的市場，而且才剛開始。所以對此沒有什麼好說的。

Okay. Got it. And then lastly for us, could you provide any commentary on NGENLA and daily going to weekly and what you've learned or what Pfizer's learned perhaps versus what's anticipated as far as costs and transference of patients from one to the other, new patients and how that may look over the coming year?

好的。知道了。最後，您能否對NGENLA 以及每日到每週的情況提供任何評論，以及您所學到的知識或輝瑞所學到的知識與預期的比較，包括成本和患者從一個患者到另一個患者的轉移、新患者以及如何進行治療。來年可能會如此？

I'll start off, Jeff. So I think what we've seen in the markets that are the most mature from Pfizer where they launched initially is good, steady growth in the conversion is happening. Broadly, I think with one of the competitors launching a bit earlier in the US market, we've seen that conversion happen, similar to what we've seen globally. We expect that to continue and accelerate as Pfizer enters the market as well as if Novo eventually enters the market with their long-acting products. So the conversions are happening, and we expect those to accelerate over the next 18 to 24 months.

我要開始了，傑夫。因此，我認為我們在輝瑞最初推出的最成熟的市場中看到的情況是好的，轉換率正在穩步增長。總的來說，我認為，隨著其中一個競爭對手在美國市場推出得更早，我們已經看到了這種轉變的發生，與我們在全球看到的情況類似。我們預計，隨著輝瑞進入市場以及 Novo 最終以其長效產品進入市場，這種情況將持續並加速。因此，轉變正在發生，我們預計這些轉變將在未來 18 至 24 個月內加速。

Okay. Perfect. And then lastly, on RAYALDEE. It sounds like you're expecting growth, and it looked like Q4 had some strong growth. Could you identify for us where that may be coming from, either demographically or geographically or pricing-wise and what we should expect for that?

好的。完美的。最後，關於 RAYALDEE。聽起來您預計會出現成長，而且第四季看起來有一些強勁的成長。您能否為我們確定這可能來自人口、地理或定價方面的來源，以及我們對此有何期望？

So Charlie's here, do you want to go ahead and take that one?

查理來了，你想繼續拿走那個嗎？

Yes, happy to do that. So we're seeing growth for a number of reasons with the RAYALDEE brand. First is the obvious passing of the adverse effects of the pandemic, which slowed the ability of our sales force to get into clinics and promote the brand, and it also slowed the ability of patients to get into the clinics to get prescriptions. That seems to have abated as of the beginning of Q2 of last year.

是的，很高興這樣做。因此，我們看到 RAYALDEE 品牌的成長有多種原因。首先是大流行的不利影響明顯過去，這減緩了我們的銷售人員進入診所和推廣品牌的能力，也減緩了患者進入診所獲取處方的能力。截至去年第二季初，這種情況似乎有所減弱。

In addition, our sales force is much more adept now at moving the product into areas of business that have low co-pays. This would include the Medicaid sector. This includes the low-income subsidy Medicare Part D patients. And it also includes the commercial patients who have zero co-pay. So these are the main drivers of the growth in the business.

此外，我們的銷售人員現在更擅長將產品轉移到自付費用較低的業務領域。這將包括醫療補助部門。這包括低收入補貼醫療保險 D 部分的病人。它還包括零自付費用的商業患者。因此，這些是業務成長的主要驅動力。

Okay. Got it. It seems like it's on a nice trajectory, post-COVID currently. Okay. I think that does it for us

好的。知道了。目前看來，疫情過後，它正處於一個良好的軌道上。好的。我認為這對我們有用

Maury Raycroft, Jefferies.

莫里‧雷克羅夫特，傑弗里斯。

Thanks for taking our questions. I was wondering if you can talk more about timing and next steps for NGENLA label expansions for the adult setting and additional pediatric indications?

感謝您回答我們的問題。我想知道您是否可以更多地談談 NGENLA 標籤擴展成人環境和其他兒科適應症的時機和後續步驟？

Yes, quickly. The adult indication, basically, we're in the process with Pfizer, obviously, to put our application to the FDA. And as I mentioned in my comments, we're now towards the end of Phase III for the pediatric indication. So timing-wise, probably the end of the year, beginning of next year for the adult and probably early next year for the pediatrics if everything goes well.

是的，很快。成人適應症，基本上，我們正​​在與輝瑞合作，顯然，將我們的申請提交給 FDA。正如我在評論中提到的，我們現在正接近兒科適應症第三階段的結束。因此，就時間而言，如果一切順利的話，成人可能是年底、明年初，兒科可能是明年初。

Got it. Okay. And then for profit share with Pfizer, I just wanted to make sure I heard this correctly, that the guidance for 2024 is $40 million to $50 million. Is that right? And wondering if there are more details you can provide on the profit share currently and how that will change as NGENLA takes more market share from GENOTROPIN. And what would a peak profit share percent look like?

知道了。好的。然後，對於與輝瑞的利潤分享，我只是想確保我聽對了，2024 年的指導為 4000 萬至 5000 萬美元。是對的嗎？想知道您是否可以提供有關當前利潤份額的更多詳細信息，以及隨著 NGENLA 從 GENOTROPIN 奪取更多市場份額，利潤份額將如何變化。峰值利潤份額百分比會是什麼樣子？

Sure. So the $40 million to $50 million, you're correct, is the full year guide based on the information we know today, right? So Pfizer doesn't separately forecast out NGENLA or GENOTROPIN sales. So we're using our internal models to calculate what we anticipate the franchise revenues to be globally. And then we apply the various tables that we have to come up with our estimated calculation. So we've got some conservatism built into that with some uncertainty on the daily portion for GENOTROPIN and modest growth rates that we would expect for NGENLA. So you've got the $40 million to $50 million right.

當然。那麼，4000 萬至 5000 萬美元，你是對的，是基於我們今天所知的資訊的全年指南，對嗎？因此輝瑞並沒有單獨預測 NGENLA 或 GENOTROPIN 的銷售額。因此，我們使用內部模型來計算我們預計的全球特許經營收入。然後我們應用我們必須得出的各種表格來進行估計計算。因此，我們對此採取了一些保守態度，其中 GENOTROPIN 的每日用量存在一定的不確定性，而 NGENLA 的增長率也與我們預期的一樣。所以你的 4000 萬到 5000 萬美元是對的。

So in the fourth quarter, if you take out the third quarter catch-up, we had about $9 million in gross profit share payments. So when you think about that modest growth that we're forecasting in, in the gross profit share, you can see what that math kind of looks like overall.

因此，在第四季度，如果剔除第三季度的追趕，我們的毛利份額付款約為 900 萬美元。因此，當您考慮我們預測的毛利份額的溫和增長時，您可以看到整體數學是什麼樣的。

When we look out at peak, when you look at the growth hormone franchise as a whole, so the combination of NGENLA and GENOTROPIN, when the product is at its peak, where we think the peak could be, and I think Pfizer has stated what they think the total market potential is for NGENLA, it's a substantial revenue stream. We have estimated an effective royalty rate to be in the mid-20s on that franchise. So at peak, it's a pretty substantial cash flow. We would expect to see the growth from now until we hit that peak.

當我們看到高峰時，當你把生長激素系列作為一個整體來看時，NGENLA 和 GENOTROPIN 的組合，當產品處於高峰時，我們認為高峰可能在哪裡，我認為輝瑞已經說明了什麼他們認為NGENLA 具有巨大的市場潛力，這是一個可觀的收入來源。我們估計該特許經營權的有效特許權使用費約為 20 多美元。因此，在高峰時期，這是一筆相當可觀的現金流。我們預計從現在開始直到達到高峰為止都會出現成長。

That's helpful. And maybe last question, just on oxyntomodulin. If you could talk about time lines for the new formulation and what would a clinical development path look like there? And is this something you're going to keep in-house or partner out? And does LeaderMed have any rights to this program?

這很有幫助。也許是最後一個問題，關於胃泌酸調節素。如果您能談談新配方的時間表以及臨床開發路徑會是什麼樣子？您打算將其保留在內部還是與合作夥伴合作？LeaderMed 對這個專案有任何權利嗎？

I think with respect to both of those questions, it's early. We'll get back to you as soon as we have something more definitive to talk about.

我認為對於這兩個問題，現在還為時過早。一旦我們有更明確的事情要討論，我們會盡快回覆您。

Okay. Thanks for taking my questions.

好的。感謝您回答我的問題。

Edward Tenthoff, Piper Sandler.

愛德華·騰索夫，派珀·桑德勒。

Great. Good evening, everyone. Two quick questions, if I may. Firstly, just at a high level with respect to NGENLA versus [GENOTROPIN]. What are the differences that Pfizer is pushing in terms of marketing? Or is it really just a land grab at this point where they're going to the GENOTROPIN clients and converting them over and basically trying to get into as many other accounts as possible?

偉大的。各位晚上好。如果可以的話，有兩個簡單的問題。首先，就 NGENLA 而言，只是在高水準上[基因勝肽]。輝瑞在行銷方面推行的差異是什麼？或者，這真的只是在此時他們去 GENOTROPIN 客戶並將其轉換並基本上試圖進入盡可能多的其他帳戶嗎？

And then the second question really for Phil. High level, as BioReference in the Diagnostic business returns to breakeven, is the plan here still to keep that as part of OPKO or potentially to monetize it, how you have for some of the other diagnostic segment/products? Do you ultimately see this business being pharma and dagnostics going forward?

接下來是菲爾的第二個問題。高水準上，隨著診斷業務中的 BioReference 恢復損益平衡，這裡的計劃是否仍將其作為 OPKO 的一部分或可能將其貨幣化，您對其他一些診斷細分市場/產品有何看法？您最終認為這項業務未來會發展為製藥和診斷學嗎？

Well, for those of you who know me, you realize that, first and foremost, we will always do what's in the best interests of the shareholders in terms of creating value. So at a particular point in time, if one approach seems advisable, we'll certainly consider it seriously.

好吧，對於那些了解我的人來說，您會意識到，首先也是最重要的是，我們將始終在創造價值方面做最符合股東利益的事情。因此，在某個特定的時間點，如果一種方法看起來是可取的，我們肯定會認真考慮它。

I don't want to be more specific than that right now. But it's clear that we have an asset on our books that is, at the moment, losing money, although we're very optimistic about turning that around that has inherent value as an asset. And so we're very mindful of that. Be assured.

我現在不想說得更具體。但很明顯，我們的帳面上有一項資產目前正在虧損，儘管我們對扭轉這一局面非常樂觀，因為它具有作為資產的內在價值。所以我們非常注意這一點。放心。

Yes. And then on the competition and sort of a little bit more on the marketing and the long-acting or weekly (inaudible).

是的。然後是關於競爭以及更多關於行銷和長效或每週的內容（聽不清楚）。

Yes. So obviously, Pfizer is leading the charge on the commercial efforts. So where we think that they are going to be very successful is in the near term is where they're alone in the market, right? So when you think about the Japanese market, which is a substantial market for the growth hormone space where they're by themselves currently, they've had meaningful market share penetration and continued growth. And there's a number of other countries where they by themselves. They've done a great job marketing throughout Europe as well and forcing the conversion or suggesting the conversion there as well.

是的。顯然，輝瑞在商業努力方面處於領先地位。因此，我們認為他們在短期內會非常成功，因為他們在市場上是獨一無二的，對嗎？因此，當你想到日本市場時，這是他們目前在生長激素領域的一個重要市場，他們已經擁有了有意義的市場份額滲透和持續成長。還有許多其他國家也有這樣的情況。他們在整個歐洲的營銷工作也做得很好，並強制進行轉換或建議在那裡進行轉換。

On the US market, they've got access commercially to a strong number of plans. We think they're well positioned with their team to go ahead and take substantial share in the US as well. As far as how they're going to go about that, I think that's a question for Pfizer to answer.

在美國市場上，他們已經獲得了大量的商業計劃。我們認為他們的團隊處於有利位置，可以繼續前進並在美國佔據大量份額。至於他們將如何去做，我認為這是輝瑞需要回答的問題。

Okay, great. Thank you, guys.

好的，太好了。感謝你們。

Yi Chen, HC Wainright & Co.

陳毅，HC Wainright & Co.

So regarding the storefront and Alibaba. Can you talk about the potential market size that OPKO can target? And what is the potential revenue contribution in 2024? And how is the current economic environment could affect your market prospects in [pet]?

那麼關於店面和阿里巴巴。您能談談OPKO可以瞄準的潛在市場規模嗎？2024 年的潛在收入貢獻是多少？當前的經濟環境如何影響您的市場前景[寵物]？

This is a product line that is very successful and is sold by our Spanish unit. They manufacture the products, develop the products and have done so well that they're beginning to expand into France, as a matter of fact, and have every intention to continue to expand geographically.

這是一條非常成功的產品線，由我們的西班牙部門銷售。他們製造產品、開發產品，並且做得非常好，以至於他們開始向法國擴張，事實上，並且有意繼續在地域上擴張。

We were approached by a company that has a partnership with Alibaba. And thinking that because of the tremendous interest in pet animals now in China and because such products as we have are successful, that we might be willing to let them distribute them through Alibaba in China. And we said, why not? And that's where we are now. It's just getting launched. So it's too early to say much more about the market size for our products that is sold by Alibaba. It's a wait-and-see situation.

一家與阿里巴巴有合作關係的公司聯繫了我們。並認為，由於中國現在對寵物產生了巨大的興趣，而且我們的此類產品很成功，因此我們可能願意讓他們透過阿里巴巴在中國分銷這些產品。我們說，為什麼不呢？這就是我們現在的處境。它剛剛推出。因此，現在談論阿里巴巴銷售的我們產品的市場規模還為時過早。這是一種觀望的情況。

So strictly animal health products, right? There are no human products offered on this storefront?

那麼嚴格來說是動物保健品，對嗎？該店面沒有提供人類產品嗎？

So there's a combination of human health and veterinary products that will eventually go on the platform.

因此，人類健康和獸醫產品的組合最終將出現在該平台上。

This concludes our question-and-answer session. I would like to turn the conference back over to Dr. Phillip Frost for any closing remarks.

我們的問答環節到此結束。我想將會議轉回給菲利普·弗羅斯特博士發表閉幕詞。

Well, we'd like to certainly thank you for participating in today's session, and we hope you'll be with us again when we report the first-quarter results. Thank you.

好吧，我們當然要感謝您參加今天的會議，我們希望您在我們報告第一季業績時再次與我們在一起。謝謝。

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

會議現已結束。感謝您參加今天的演示，您現在可以斷開連接了。