Lantheus Holdings Inc (LNTH) 2024 Q4 法說會逐字稿

Good morning. Welcome to the Lantheus fourth quarter and full year 2024 conference call. (Operator Instructions) This call is being recorded, and a replay will be available in the Investors section of the company's website approximately 2 hours after the completion of the call. The call will be archived for at least 30 days.

早安.歡迎參加 Lantheus 2024 年第四季和全年電話會議。（操作員指示）本次通話將被錄音，通話結束後約 2 小時將在公司網站的「投資者」部分提供重播。該通話將存檔至少 30 天。

I will now turn the call over to Mark Kinarney, Vice President of Investor Relations. Mark?

現在我將電話轉給投資者關係副總裁馬克金納尼 (Mark Kinarney)。標記？

Thank you. Good morning. With me today are Brian Markison, our CEO; Paul Blanchfield, our President; Bob Marshall, our CFO; and Amanda Morgan, our Chief Commercial Officer. We will begin with prepared remarks and then open the call for Q&A.

謝謝。早安.今天和我一起的還有我們的執行長 Brian Markison；我們的總裁 Paul Blanchfield；我們的財務長 Bob Marshall；以及我們的商務長阿曼達摩根 (Amanda Morgan)。我們將從準備好的演講開始，然後開始問答環節。

This morning, we issued a press release, which was furnished to the SEC under Form 8-K, reporting our fourth quarter 2024 results. The release and today's slide presentation are in the Investors section of our website. Any comments made could include forward-looking statements. Actual results may differ materially from these statements due to a variety of risks and uncertainties which are detailed in our SEC filings. Discussions will also include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included in the Investors section of our website.

今天早上，我們發布了一份新聞稿，以 8-K 表格形式提交給美國證券交易委員會，報告了我們 2024 年第四季的表現。這份新聞稿和今天的幻燈片簡報位於我們網站的「投資者」部分。任何評論都可能包含前瞻性陳述。由於我們提交給美國證券交易委員會的文件中詳細說明的各種風險和不確定性，實際結果可能與這些聲明有重大差異。討論還將包括某些非公認會計準則財務指標。這些指標與最直接可比較的 GAAP 財務指標的對帳內容包含在我們網站的「投資者」部分。

I will now turn the call over to our CEO, Brian.

現在我將電話轉給我們的執行長布萊恩。

Thank you, Mark, and good morning, everyone. 2024 was a ground-breaking year as we achieved a number of important milestones and enhanced our capabilities as the leading radiopharmaceutical focus. I am immensely proud of our team and the meaningful difference we have made in the lives of over 7 million patients in 2024.

謝謝你，馬克，大家早安。 2024 年是開創性的一年，我們實現了許多重要的里程碑，並增強了我們作為領先放射性藥物焦點的能力。我為我們的團隊以及我們在 2024 年為超過 700 萬名患者的生活帶來的有意義的改變感到無比自豪。

Our strong performance in the fourth quarter and throughout all of 2024 was driven by our commitment to operational excellence. We remain focused on further expanding our radiopharmaceutical excellence through a leading commercial portfolio, innovative pipeline, and differentiated capabilities. Last month, we announced two strategic transactions that have the potential to, first, enhance our capabilities across the radiopharmaceutical value chain, including in Alzheimer's Diagnostics and Oncology Therapeutics; second, allow us to enter new markets with significant growth potential that diversify our business; third, expand our pipeline with potentially best or first-in-class radiopharmaceutical theranostic pairs that make use of our existing expertise and fourth, help to drive sustained double-digit revenue growth beginning in 2026.

我們在第四季以及整個 2024 年的強勁表現得益於我們對卓越營運的承諾。我們將繼續致力於透過領先的商業產品組合、創新管道和差異化能力進一步擴大我們的放射性藥物優勢。上個月，我們宣布了兩項策略交易，首先，這些交易有可能增強我們在整個放射性藥物價值鏈中的能力，包括阿茲海默症診斷和腫瘤治療領域；第二，讓我們進入具有巨大增長潛力的新市場，實現業務多元化；第三，利用我們現有的專業知識，擴大我們的產品線，推出潛在的最佳或一流的放射性藥物治療診斷對第四；

Life Molecular Imaging will support our future growth with the addition of Neuroseq, an approved radiodiagnostic for Alzheimer's disease, expand our capabilities with an Alzheimer's commercial franchise as well as an enhanced R&D and clinical development capabilities and grow our pipeline. Evergreen Theragnostics has the potential to add OCTEVY, a registrational stage PET radio diagnostics that complements our therapeutic registrational stage candidate, PNT2003, strengthen our clinical and commercial manufacturing capabilities and multiple clinical and preclinical assets to the pipeline and enhance our early-stage R&D capabilities quite significantly. Both acquisitions are subject to customary closing conditions and are expected to close in the second half of this year.

生命分子影像將透過增加 Neuroseq（一種經批准的阿茲海默症放射診斷方法）來支持我們未來的成長，透過阿茲海默症商業特許經營權擴展我們的能力以及增強的研發和臨床開發能力並擴大我們的產品線。Evergreen Theragnostics 有潛力添加 OCTEVY，這是一種註冊階段的 PET 放射診斷產品，可補充我們的治療註冊階段候選藥物 PNT2003，增強我們的臨床和商業製造能力以及多種臨床和臨床前資產，並顯著增強我們的早期研發能力。這兩項收購均需滿足慣例成交條件，預計今年下半年完成。

Throughout 2024, we also executed a series of asset and in-licensing deals to expand our pipeline. We are excited about these potentially best or first-in-class agents for Alzheimer's disease and oncology and plan to advance them during the year.

在整個 2024 年，我們也執行了一系列資產和授權交易，以擴大我們的產品線。我們對這些潛在的最佳或一流的阿茲海默症和腫瘤治療藥物感到非常興奮，並計劃在今年內推進它們的發展。

Operationally, we grew PYLARIFY to over $1 billion in sales, making it the first ever radiodiagnostic blockbuster and the clear number one utilized PSA PET imaging agent. We also grew our market-leading ultrasound-enhancing agent, DEFINITY, double digits in its 24th year on the market. In November, CMS issued its calendar year 2025 rule, which enhanced payment from specialized diagnostic radiopharmaceuticals for covered products. This was a significant step that will support lower-term radiopharmaceutical diagnostic innovation.

在營運方面，我們將 PYLARIFY 的銷售額提升至 10 億美元以上，使其成為有史以來第一個放射診斷重磅藥物，並且是使用率第一的 PSA PET 成像劑。我們的市場領先的超音波增強劑 DEFINITY 在上市第 24 年也實現了兩位數的成長。11 月，CMS 發布了 2025 日曆年規則，該規則提高了針對承保產品的專用診斷放射性藥物的付款。這是支持短期放射性藥物診斷創新的重要一步。

We entered 2025 focused on leading the renaissance in radiopharmaceuticals, growing both our flagship diagnostic agents, advancing our pipeline, closing our two recently announced transactions and delivering value to our patients, customers, employees and shareholders.

進入 2025 年，我們將專注於引領放射性藥物的復興，發展我們的旗艦診斷劑，推進我們的產品線，完成我們最近宣布的兩項交易，為我們的患者、客戶、員工和股東創造價值。

With that, I'll turn the call over to Paul to provide an update on our operational performance. Paul?

說完這些，我將把電話轉給保羅，讓他報告我們的營運表現。保羅？

Thank you, Brian. I'm incredibly proud of our team's performance in 2024 and excited about the opportunities in front of us in 2025. With over $1 billion in sales, PYLARIFY remains the clear number one utilized PSMA PET imaging agent. We plan to build on this success by growing both volume and net sales in 2025 and are confident that we will maintain our market leadership and relative price premium, even amidst competitive pressures.

謝謝你，布萊恩。我對我們團隊在 2024 年的表現感到無比自豪，並對 2025 年擺在我們面前的機會感到興奮。PYLARIFY 的銷售額超過 10 億美元，仍然是使用率第一的 PSMA PET 造影劑。我們計劃在此基礎上再接再厲，在 2025 年實現銷售和淨銷售額的成長，並且有信心，即使在競爭壓力下，我們也將保持市場領先地位和相對價格溢價。

PYLARIFY sales for the quarter were $266 million, up 15.7% year over year. Growth was driven by volume as net price was up approximately 1% year over year, even after taking a mid-single-digit price increase at the beginning of 2024. Quarter over quarter, we grew volumes just shy of 2%, with net price essentially flat.

PYLARIFY 本季銷售額為 2.66 億美元，較去年同期成長 15.7%。成長是由銷量推動的，因為即使在 2024 年初價格出現中等個位數上漲之後，淨價格仍同比上漲約 1%。與上一季相比，我們的銷量成長了近 2%，而淨價基本上持平。

Fueling this growth is the continued expansion of the PSMA PET current addressable market, which we estimate to be $2.5 billion-plus in 2025 up from $2 billion-plus in 2024, while the total addressable market could exceed $3.5 billion by the end of the decade. Year over year market growth is expected to be driven by the continued conversion of bone scans in the initial staging and BCR patient segment, and we expect our customer base to grow their PSMA PET volumes accordingly, as the vast majority of our hospital and freestanding imaging business are now under long-term strategic partnership agreements. We took an almost 6% WACC price increase earlier in 2025 and expect PYLARIFY's clinical and commercial differentiation to continue to support its clear market leadership and premium pricing.

推動這一成長的是 PSMA PET 當前潛在市場的持續擴張，我們估計該市場規模將從 2024 年的 20 億美元以上增長到 2025 年的 25 億美元以上，而到 2020 年，總潛在市場規模可能超過 35 億美元。預計逐年市場成長將受到初始分期和 BCR 患者領域骨掃描持續轉換的推動，並且我們預計我們的客戶群將相應增加其 PSMA PET 數量，因為我們絕大多數的醫院和獨立成像業務現在都處於長期戰略合作協議之下。我們在 2025 年初將 WACC 價格提高了近 6%，並預計 PYLARIFY 的臨床和商業差異化將繼續支持其明顯的市場領導地位和溢價。

As Brian mentioned, we are pleased with CMS' new payment policy, which recognizes the value of and ensures access to innovative radio diagnostics. The rule provides separate payment for innovative radiopharmaceutical diagnostics like PYLARIFY, following expiry of transitional pass-through payment status for the approximately 20% of patients with traditional Medicare fee-for-service insurance coverage who are treated in the hospital outpatient setting.

正如 Brian 所提到的，我們對 CMS 的新支付政策感到滿意，該政策承認創新放射診斷的價值並確保了其可及性。該規則規定，在對約 20% 享受傳統醫療保險按服務收費保險且在醫院門診接受治療的患者的過渡性轉付費用狀態到期後，將對 PYLARIFY 等創新放射性藥物診斷提供單獨付費。

PYLARIFY OPPS Medicare fee-for-service payment rates are in a significantly better position than they would have been absent CMS' adoption of separate payment, and we plan to continue to engage CMS as well as other stakeholders to establish a payment based on average sales price, or ASP. Lantheus has been reporting PYLARIFY's ASP since launch, and we believe other radiopharmaceutical diagnostics can as well, which would facilitate CMS' ability to establish ASP as the basis for separate payment in the future.

PYLARIFY OPPS 醫療保險按服務收費率比沒有 CMS 採用單獨支付的情況要好得多，我們計劃繼續與 CMS 以及其他利益相關者合作，建立基於平均銷售價格或 ASP 的支付方式。Lantheus 自推出以來一直在報告 PYLARIFY 的 ASP，我們相信其他放射性藥物診斷也可以這樣做，這將有助於 CMS 在未來將 ASP 確立為單獨付款的基礎。

More broadly, we believe this rule represents significant progress for the long-term potential and sustainability of our existing diagnostic pipeline, including MK-6240 and NAV-4694 as well as those agents that would be included in our recently announced strategic transactions. We continue to invest in PYLARIFY, including assessing the benefits of PSMA PET imaging with polarity and intermediate favorable patients via the MIRROR study, which continues to enroll as well as in PSMA expressing tumors beyond prostate through additional Phase IV studies. We look forward to sharing more about our progress throughout 2025.

更廣泛地說，我們認為這項規則代表著我們現有診斷管道的長期潛力和可持續性取得了重大進展，包括 MK-6240 和 NAV-4694 以及那些將包含在我們最近宣布的策略交易中的藥物。我們將繼續投資 PYLARIFY，包括透過 MIRROR 研究評估 PSMA PET 影像對極性和中度有利患者的益處，該研究將繼續招募患者，並透過額外的 IV 期研究對前列腺以外的 PSMA 表達腫瘤進行評估。我們期待在 2025 年分享更多我們的進展。

DEFINITY continues to be the number one utilized ultrasound-enhancing agent delivering fourth quarter net sales of $86.2 million, up 17.9% year over year. DEFINITY exceeded our expectations in the second half of the year due to competitor supply chain challenges that led to higher-than-anticipated market share. DEFINITY's long-term success continues to be driven by its established clinical and commercial value, strong history of clinical application and our ongoing commitment to operational excellence.

DEFINITY 繼續成為使用率第一的超音波增強劑，第四季淨銷售額達 8,620 萬美元，年增 17.9%。由於競爭對手的供應鏈挑戰導致市場份額高於預期，DEFINITY 在下半年的業績超出了我們的預期。DEFINITY 的長期成功持續受到其既定的臨床和商業價值、強大的臨床應用歷史以及我們對卓越營運的持續承諾的推動。

In neurology, we continue to progress our pipeline of radio diagnostics for Alzheimer's disease or AD. We believe the US AD radio diagnostics total addressable market has the potential to grow to $1.5 billion by the end of the decade, driven by the increasing number of treatment options expected to become available as well as increasing prevalence. This is supported by third-party research which estimates there to be over 100 therapies in clinical development targeting either beta amyloid or TAP.

在神經病學領域，我們繼續推進阿茲海默症或 AD 的放射診斷方法。我們相信，隨著治療方案的不斷增加以及盛行率的不斷提高，美國 AD 放射診斷總目標市場到 2020 年有潛力增長到 15 億美元。第三方研究也支持這一觀點，該研究估計目前有超過 100 種針對 β 澱粉樣蛋白或 TAP 的療法處於臨床開發階段。

Furthermore, the Alzheimer's Association Work Group and SNMMI, recently updated their guidelines to expand the appropriate use of both beta amyloid and tau PET imaging for diagnosis, prognosis, eligibility, response prediction and monitoring of select patient groups. Finally, a recent Alzheimer's and dementia Journal survey found that 90% of the nearly 300 dementia experts surveyed thought tau PET tracers will add value to clinical practice in a cognitively impaired memory clinic population. We believe we are well positioned to aid in the diagnosis, staging and monitoring of AD with MK-6240 and NAV-4694 as well as with the agents we expect to acquire via Life Molecular Imaging.

此外，阿茲海默症協會工作小組和 SNMMI 最近更新了他們的指南，以擴大 β 澱粉樣蛋白和 tau PET 成像在特定患者群體的診斷、預後、資格、反應預測和監測中的適當使用。最後，《阿茲海默症和癡呆症雜誌》最近的一項調查發現，在接受調查的近 300 名癡呆症專家中，90% 的人認為 tau PET 追蹤劑將為認知障礙記憶診所人群的臨床實踐增添價值。我們相信，我們有能力利用 MK-6240 和 NAV-4694 以及我們期望透過生命分子影像獲得的藥物來輔助 AD 的診斷、分期和監測。

Life Molecular Imaging would add an existing commercial AD franchise, accelerating our entry in the AD and dementia space with Neuroseq, a globally approved F-18 PET imaging agent that estimates beta-amyloid plaque density in adult patients with cognitive impairment who are being evaluated for AD and other causes of cognitive decline. Neuroseq has shown clinical differentiation from other approved beta amyloid agents, and we plan to use our experience and capabilities in F-18-based radio diagnostics and those of Life Molecular's team to grow this business.

Life Molecular Imaging 將增加現有的商業 AD 特許經營權，透過 Neuroseq 加速我們進入 AD 和癡呆症領域，Neuroseq 是一種全球認可的 F-18 PET 成像劑，可估算正在接受 AD 和其他認知能力下降原因評估的認知障礙成年患者的 β-澱粉樣蛋白斑塊密度。Neuroseq 已顯示出與其他核准的 β 澱粉樣蛋白藥物的臨床差異，我們計劃利用我們在基於 F-18 的放射診斷方面的經驗和能力以及 Life Molecular 團隊的經驗和能力來發展這項業務。

We believe that our radio diagnostic portfolio, including NAV-4694 and MK-6240 are highly complementary to Life Molecular's portfolio, including Neuroseq and PI-2620. We remain on track to submit an NDA for MK-6240 in 2025 and an NDA for NAV-4694 in 2026, and to close the Life Molecular transaction in the second half of 2025.

我們相信，我們的放射診斷產品組合（包括 NAV-4694 和 MK-6240）與 Life Molecular 的產品組合（包括 Neuroseq 和 PI-2620）高度互補。我們仍有望在 2025 年提交 MK-6240 的 NDA，在 2026 年提交 NAV-4694 的 NDA，並在 2025 年下半年完成 Life Molecular 交易。

We are excited about our pipeline, including the pending addition of Evergreen's registrational stage, net radiodiagnostic, OCTEVY, which would complement our therapeutic radio equivalent candidate PNT2003 and could deliver a theranostic-like pair. Pending the acquisition of Evergreen, receipt of FDA approvals and positive resolution of the PNT2003 patent litigation, we expect to launch both products in 2026 and could offer near-term revenue potential and diversification. We are also excited about the potential of Evergreen's clinical and preclinical theranostic pairs targeting novel molecular oncologic targets.

我們對我們的產品線感到興奮，包括即將加入的 Evergreen 註冊階段的網路放射診斷 OCTEVY，它將補充我們的治療放射等效候選藥物 PNT2003，並可以提供類似治療診斷的配對。在收購 Evergreen、獲得 FDA 批准以及 PNT2003 專利訴訟得到積極解決之後，我們預計將於 2026 年推出這兩款產品，並可能在短期內帶來收入潛力和多樣化。我們也對 Evergreen 針對新型分子腫瘤標靶的臨床和臨床前治療診斷對的潛力感到興奮。

Finally, we continue to advance our other clinical radiopharmaceutical programs that have the potential to be first or best-in-class in areas of significant unmet need. These include our RM2 novel theranostic pair targeting GRPR, otherwise known as bombesin, for prostate, breast and other cancers, which we plan to advance to an IND later this year. And our BARK-15 targeted radio therapeutic for the treatment of osteosarcoma and other solid tumors as well as our TROP-2 targeted radiotherapeutic.

最後，我們繼續推進其他臨床放射性藥物項目，這些項目有可能在尚未滿足的重大需求領域成為首創或一流的項目。其中包括我們針對 GRPR（也稱為炸彈素）的 RM2 新型治療診斷對，用於治療前列腺癌、乳腺癌和其他癌症，我們計劃在今年稍後將其推進至 IND。我們的 BARK-15 標靶放射治療用於治療骨肉瘤和其他實體腫瘤，以及我們的 TROP-2 標靶放射治療。

I will now turn the call over to Bob.

我現在將電話轉給鮑伯。

Thank you, Paul, and good morning, everyone. I will provide highlights of the fourth quarter and full year financials, focusing on adjusted results with comparisons to the prior year period, unless otherwise noted.

謝謝你，保羅，大家早安。我將提供第四季度和全年財務狀況的重點，重點關注調整後的結果並與去年同期進行比較，除非另有說明。

Revenue for the fourth quarter was $391.1 million, an increase of 10.5% and revenue for the full year was $1.534 billion, an increase of 18.3%. Now turning to the details, beginning with radio pharmaceutical oncology, which contributed $266 million of sales in the quarter, up 15.3% due primarily to the continued strength of PYLARIFY with sales of $266 million, an increase of 15.7%. The difference in growth rates is due to a nominal amount of AZEDRA sales in the prior year results.

第四季營收為3.911億美元，年增10.5%，全年營收為15.34億美元，年增18.3%。現在談談細節，首先是放射藥物腫瘤學，該領域在本季度貢獻了 2.66 億美元的銷售額，增長 15.3%，這主要歸功於 PYLARIFY 的持續強勁表現，其銷售額達到 2.66 億美元，增長 15.7%。成長率的差異是由於上一年 AZEDRA 的銷售額很小。

PYLARIFY posted full year sales of $1.058 billion, an increase of 24.3%. Precision diagnostics' fourth quarter revenue of $117.5 million was 16.8% higher, driven by DEFINITY at $86.2 million or 17.9% higher. And TechneLite at $25.1 million was up 16.7%. For the full year, DEFINITY revenue was $317.8 million, up 13.6%, and TechneLite revenue was $95.5 million, up 9.3%. Lastly, strategic partnerships and other revenue was $7.7 million, down 66.2% for the fourth quarter due to the inclusion of a RELISTOR royalty milestone received in the prior year.

PYLARIFY 全年銷售額為 10.58 億美元，成長 24.3%。Precision Diagnostics 第四季營收為 1.175 億美元，年增 16.8%，其中 DEFINITY 營收為 8,620 萬美元，年增 17.9%。TechneLite 股價上漲 16.7%，至 2,510 萬美元。全年來看，DEFINITY 營收為 3.178 億美元，成長 13.6%，TechneLite 營收為 9,550 萬美元，成長 9.3%。最後，戰略合作夥伴關係和其他收入為 770 萬美元，由於納入了上一年收到的 RELISTOR 特許權使用費里程碑，第四季度下降了 66.2%。

Full year revenue was $38.2 million, led by sales of MK-6240 for investigational use in third-party clinical trials. Gross profit margin for the fourth quarter was 68% and in line with the full year result of 68.3%, but down 130 basis points year over year due mainly to the RELISTOR royalty milestones embedded in the prior year quarter, offset in part by favorable product mix, with strong volume contributions from across the commercial portfolio.

全年收入為 3,820 萬美元，主要得益於用於第三方臨床試驗研究的 MK-6240 的銷售額。第四季毛利率為 68%，與全年 68.3% 的毛利率持平，但同比下降 130 個基點，主要原因是去年同期已包含 RELISTOR 特許權使用費里程碑，但有利的產品組合部分抵消了這一影響，整個商業產品組合的銷量貢獻強勁。

Operating expenses at 29.1% of net revenue in the quarter were 670 basis points unfavorable from the prior year but within previously guided spending levels. Increases in research and development were planned investments to advance our innovative clinical stage portfolio. G&A was notably higher in the period with significant expense tied to business development activities relating to the potential acquisitions of Life Molecular and Evergreen Theragnostics, including, but not limited to, due diligence and legal expenses. The company does not adjust the management P&L for these types of expenses unless the specific transaction is signed within the same quarter.

本季營運費用佔淨收入的 29.1%，比上年低 670 個基點，但在先前指導的支出水準之內。增加研發投資是為了推動我們創新的臨床階段產品組合。本期間的一般及行政費用顯著增加，主要原因是與 Life Molecular 和 Evergreen Theragnostics 的潛在收購相關的業務開發活動產生了大量費用，包括但不限於盡職調查和法律費用。除非特定交易在同一季度內簽署，否則公司不會針對這些類型的費用調整管理損益表。

Other income and expense was $4.4 million of income for the quarter and $17.6 million for the year, derived through interest income earned on invested cash balances offset by interest expense on the company's debt. Operating profit for the quarter was $151.8 million, a decrease of 8.4% and $643.3 million for the full year, an increase of 7.7%.

其他收入和支出本季為 440 萬美元，全年為 1,760 萬美元，來自投資現金餘額所賺取的利息收入與公司債務的利息支出相抵。本季營業利潤為1.518億美元，下降8.4%，全年營業利潤為6.433億美元，成長7.7%。

Total adjustments in the quarter totaled $157 million of expense before taxes. Of this amount, $22.2 million and $11.8 million of expense is associated with noncash stock and incentive plans and acquired intangible amortization, respectively. A portion of the stock compensation expense is related to headcount optimization, which took place last November.

本季的總調整額為稅前支出 1.57 億美元。其中，2,220 萬美元和 1,180 萬美元的支出分別與非現金股票和激勵計畫以及獲得的無形資產攤銷有關。部分股票薪酬費用與去年 11 月進行的員工人數優化有關。

The company recorded an unrecognized loss of $119.1 million attributable to its equity investment in prospective in Radiopharm Theranostics. The remainder is related to acquisition, integration and other nonrecurring expenses. Our effective tax rate was 26.1% in the quarter and 26.7% for the full year. The resulting reported net loss for the fourth quarter was $11.8 million, and a profit of $115.4 million on an adjusted basis, a decrease of 5.9% from the prior year period.

該公司因對 Radiopharm Theranostics 的潛在股權投資而錄得 1.191 億美元的未確認損失。其餘部分則與收購、整合和其他非經常性費用有關。本季我們的有效稅率為 26.1%，全年有效稅率為 26.7%。第四季淨虧損為 1,180 萬美元，調整後利潤為 1.154 億美元，較去年同期下降 5.9%。

GAAP fully diluted earnings per share for the fourth quarter were a loss of $0.17 and a profit of $1.59 on an adjusted basis, a decrease in the prior year of 9%. On a full year basis, GAAP fully diluted earnings per share were a profit of $4.36 and a profit of $6.76 on an adjusted basis, an increase of 8.6% over the prior year.

第四季 GAAP 完全稀釋每股盈餘為虧損 0.17 美元，調整後獲利 1.59 美元，較上年同期下降 9%。全年以 GAAP 計算的每股完全攤薄收益為 4.36 美元，以調整後計算的每股收益為 6.76 美元，較上年增長 8.6%。

Now turning to cash flow. Fourth quarter operating cash flow totaled $157.7 million as compared to $112 million in Q4 2023. Capital expenditures totaled $16.4 million, $4.3 million more than the year prior. Free cash flow, which we define as operating cash flow less capital expenditures, was $141.4 million, an increase of $41.1 million.

現在轉向現金流。第四季營運現金流總計 1.577 億美元，而 2023 年第四季為 1.12 億美元。資本支出總計 1,640 萬美元，較前一年增加 430 萬美元。自由現金流（我們將其定義為經營現金流減去資本支出）為 1.414 億美元，增加了 4,110 萬美元。

During the full year, the company generated $493.1 million of free cash flow. Additionally, the company repurchased approximately $100 million or [1.2 million] of its own shares during the quarter, leaving $150 million of buyback authorization outstanding.

全年該公司產生了4.931億美元的自由現金流。此外，該公司在本季回購了約 1 億美元（120 萬美元）的自有股票，剩餘 1.5 億美元的回購授權尚未兌現。

During the fourth quarter, the company refinanced its revolving senior credit facility, increasing borrowing capacity to $750 million from $350 million and extended the maturity date to 2029, enhancing our strong liquidity position. Lastly, cash and cash equivalents net of restricted cash, now stand at $912.8 million.

第四季度，該公司對其循環高級信貸額度進行了再融資，將借款能力從 3.5 億美元提高至 7.5 億美元，並將到期日延長至 2029 年，從而增強了我們強大的流動性狀況。最後，扣除受限現金後的現金和現金等價物現為 9.128 億美元。

Turning now to guidance for 2025 full year. And recall, we are only providing full year guidance this year. Additionally, this guide does not include the pro forma impacts of previously announced transactions expected to close later this year, namely Life Molecular Imaging and Evergreen. The company will update financial expectations after each transaction is actually closed.

現在來談談 2025 年全年的指導。請記住，我們今年只提供全年指導。此外，本指南不包括預計今年稍後完成的先前宣布的交易（即 Life Molecular Imaging 和 Evergreen）的預測影響。每筆交易實際結束後，公司都會更新財務預期。

We estimate full year net revenue to be in the range of $1.545 billion to $1.61 billion an increase of 1% to 5% over 2024. We expect PYLARIFY to grow low to mid-single digits on a net basis. DEFINITY with a low to mid-single-digit growth profile, will face headwinds from opportunistic sales in 2024, but maintain a two-year stacked growth rate of high single digits.

我們預計全年淨收入將在 15.45 億美元至 16.1 億美元之間，比 2024 年成長 1% 至 5%。我們預計 PYLARIFY 的淨成長率將達到低至中個位數。DEFINITY 的成長速度處於低至中等個位數之間，將在 2024 年面臨機會性銷售的阻力，但將保持兩年的高個位數成長率。

For modeling purposes, gross profit margin should be materially similar to 2024 levels at approximately 68%. Operating expenses should be reflective of the second half of 2024, which favors R&D investment. Overall, sales and marketing and G&A expenses should be flat to down year over year with R&D investment up 100 basis points to 150 basis points, all as a percent of net revenue.

為了建模目的，毛利率應與 2024 年的水準基本相似，約為 68%。營運費用應反映2024年下半年的情況，有利於研發投資。總體而言，銷售和行銷以及一般行政費用應與去年同期持平或下降，而研發投資將上升 100 個基點至 150 個基點，所有這些佔淨收入的百分比。

Interest income, given heightened cash balances and the forward curve to provide $40 million of income, though offset by $19.5 million of interest expense. Therefore, for the full year, we expect fully diluted adjusted earnings per share to be in the range of $7 and $7.20, an increase of 3.5% to 6.5% over 2024.

利息收入，由於現金餘額增加和遠期曲線提供 4000 萬美元的收入，但被 1950 萬美元的利息支出所抵消。因此，我們預計全年全面攤薄調整後每股收益將在 7 美元至 7.20 美元之間，比 2024 年增長 3.5% 至 6.5%。

Lastly, the company expects free cash flow to continue to expand through 2025, with an anticipated amount of $550 million to $600 million, providing the company along with current cash balances, more than sufficient liquidity to execute its business development priorities as well as returning a portion to stockholders through buybacks.

最後，該公司預計自由現金流將在 2025 年繼續擴大，預計達到 5.5 億美元至 6 億美元，這將為公司提供充足的流動性以及當前的現金餘額，以執行其業務發展重點，並透過回購將一部分資金返還給股東。

Finally, for modeling purposes, depreciation and amortization for the full year 2025 should be approximately $15 million and $41 million, respectively, generally spread evenly throughout the year. Fully diluted shares outstanding should be approximately 71.5 million, which takes into account the share repurchase executed in Q4.

最後，出於建模目的，2025 年全年的折舊和攤銷應分別約為 1500 萬美元和 4,100 萬美元，通常均勻分佈在全年。考慮到第四季執行的股票回購，完全稀釋的流通股數應約為 7,150 萬股。

With that, I'll turn the call back over to Brian.

說完這些，我就把電話轉回給布萊恩。

Thank you, Bob. We are pleased with our strong performance in 2024 and excited about our momentum in 2025 and beyond. We are well positioned to grow PYLARIFY and DEFINITY, advance our existing pipeline and close out two recently announced strategic transactions to become a fully integrated radiopharmaceutical company.

謝謝你，鮑伯。我們對 2024 年的強勁表現感到滿意，並對 2025 年及以後的發展勢頭感到興奮。我們已做好準備，發展 PYLARIFY 和 DEFINITY，推進現有產品線，並完成最近宣布的兩項策略交易，從而成為一家完全整合的放射性製藥公司。

These pending transactions will enable us to concentrate on enhancing our capabilities across the radiopharmaceutical value chain, including in Alzheimer's diagnostics and oncology therapeutics, entering new markets with significant growth potential that diversify our business, and expanding our pipeline with potentially best or first-in-class radiopharmaceutical theranostic pairs, including the potential for multiple commercially approved products in 2026.

這些待定交易將使我們能夠集中精力提高我們在放射性藥物價值鏈中的能力，包括阿茲海默症診斷和腫瘤治療，進入具有巨大增長潛力的新市場，實現業務多元化，並通過潛在的最佳或一流的放射性藥物治療診斷對擴展我們的產品線，包括 2026 年多個獲得商業批准的產品的可能性。

In closing, we are confident that our strategy will enhance our radiopharmaceutical leadership, drive growth, build long-term shareholder value and bring innovative products to patients.

最後，我們相信我們的策略將增強我們的放射性藥物領導地位，推動成長，建立長期股東價值並為患者帶來創新產品。

With that, we're ready to take your questions. Operator, please go ahead.

現在，我們已經準備好回答您的問題了。接線員，請繼續。

(Operator Instructions)

（操作員指示）

Roanna Ruiz, Leerink Partners.

Roanna Ruiz，Leerink Partners。

I was curious, could you give us a status update on the MIRROR study that you mentioned briefly? And talk a bit about more it's implications on PYLARIFY. And I was curious if the timing is still on track or a little bit delayed versus what you thought before.

我很好奇，您能否向我們介紹一下您簡單提到的 MIRROR 研究的最新進展？並進一步討論它對 PYLARIFY 的影響。我很好奇時間安排是否仍然在按計劃進行，還是與您之前想像的相比略有延遲。

Roanna, thanks for the question. So the MIRROR study is our study to assess the use of PSMA PET with PYLARIFY in the intermediate favorable setting. As a reminder, this is not necessarily, if you will, a registrational study because PYLARIFY has a very broad label in the staging where it identifies the risk of metastases but it doesn't distinguish the level of risk. And so the NCCN and the SNMMI and other guidelines agencies has effectively recommended use of PSMA PET with PYLARIFY in their intermediate unfavorable and the high and very high-risk patient population, we began studying PSMA PET with PYLARIFY in intermediate favorable patients.

Roanna，謝謝你的提問。因此，MIRROR 研究是我們評估在中間有利環境下使用 PSMA PET 與 PYLARIFY 的研究。提醒一下，這不一定是註冊研究，因為 PYLARIFY 在分期方面有非常廣泛的標籤，它可以識別轉移的風險，但不能區分風險等級。因此，NCCN 和 SNMMI 以及其他指導機構已有效推薦在中度不利、高風險和極高風險患者群體中使用 PSMA PET 和 PYLARIFY，我們開始在中度有利患者中研究 PSMA PET 和 PYLARIFY。

Last year, that continues to enroll. We would expect to have the last patient in sometime in the fourth quarter of 2025, then to be able to follow those patients, do the right clinical trial analysis as well as publishing with the hopes of having guidelines from NCCN and SNMMI updated in the coming years, which then could influence payer policies and overall expand the addressable market for the staging population. And I think you'll note that in our total addressable market we would expect that staging population to increase from approximately 145,000 scans annually potential today to approximately 175,000 by the end of the decade.

去年，該校繼續招生。我們預計將在 2025 年第四季的某個時候迎來最後一位患者，然後能夠追蹤這些患者，進行正確的臨床試驗分析並發表研究成果，希望 NCCN 和 SNMMI 的指南能夠在未來幾年內得到更新，從而影響付款人政策並全面擴大分期人群的潛在市場。我想你會注意到，在我們的總體目標市場中，我們預計分期人口將從目前每年約 145,000 次掃描增加到本世紀末的約 175,000 次。

Anthony Petrone, Mizuho Financial Group.

瑞穗金融集團的安東尼‧佩特羅內 (Anthony Petrone)。

And congrats on just a strong year overall, getting PYLARIFY to $1 billion in the recent transactions. Maybe just to stick on the US PSMA PET dynamics. So maybe one, just a little bit on the competitive dynamics with the new reimbursement change that's effective January 1. I know you mentioned most of your customers are now contracted, but just anything you're seeing competitively of market shifts as this new reimbursement code has come in?

恭喜 PYLARIFY 整體表現強勁，在最近的交易中其交易額達到 10 億美元。也許只是堅持美國 PSMA PET 動態。因此，也許首先要談談 1 月 1 日生效的新報銷變化所帶來的競爭動態。我知道您提到現在大多數客戶都已簽訂了合同，但是隨著新的報銷代碼的出台，您所看到的市場競爭力是否發生了變化？

And then secondly, the competitors out there looking at basically a reengineered reformulated version, if you will, of their PSMA PET agent. Just expectations on that on whether or not that's baked into the guide. And what you think that does for the competitive landscape. And congrats on a strong year all around.

其次，如果你願意的話，競爭對手基本上正在研究重新設計的 PSMA PET 藥劑的配方版本。只是對此是否被納入指南中抱持期望。您認為這對競爭格局有何影響？恭喜您度過了一個豐碩的一年。

Yeah. Thanks, Anthony. I'll start with the back end of your question and then turn it over to Paul and Amanda for the second half -- or the first question -- part of the question anyway. With regard to a new product entrant, I think it's Gallium. The images are not as good as PYLARIFY images. There's been a little bit of noise about it. I don't really see a big sort of influx to anything that's happening with PYLARIFY, so they're doing what they're doing good for them, and we're going to keep on executing our game plan. So Paul?

是的。謝謝，安東尼。我將從您問題的後端開始，然後將其交給保羅和阿曼達來回答後半部分——或者第一個問題——無論如何都是問題的一部分。對於新產品進入者，我認為是鎵。這些圖像不如 PYLARIFY 圖像好。關於此事有一些爭論。我確實沒有看到 PYLARIFY 發生任何大規模湧入，所以他們正在做對他們有利的事情，我們將繼續執行我們的遊戲計劃。那麼保羅？

Yeah. No, Anthony, thanks for the question. Maybe I'll just tackle some of the MUC kind of CMS piece, and then I'll turn it over to Amanda to talk about some of the competitive dynamics that we're seeing in the marketplace.

是的。不，安東尼，謝謝你的提問。也許我只會處理一些 MUC 類型的 CMS 部分，然後我會把它交給 Amanda 來談談我們在市場上看到的一些競爭動態。

So I think as we said, I think we're incredibly excited about the CMS shift to MUC versus where we were previously expected to be from the expiry of transitional pass-through payment status. And this is clearly a benefit for PYLARIFY. But I think more broadly, as the clear leader in radiopharmaceutical diagnostics, with PYLARIFY, an incredibly strong pipeline with MK-6240, of NAV-4694, of our FAB agent earlier in development as well as some of the pending acquisitions with the addition of OCTEVY, of Neuroseq and earlier-stage theranostic pairs, I think we're incredibly pleased for the long-term growth potential, sustainability and payment dynamics related to MUC.

因此，我認為，正如我們所說的那樣，我們對 CMS 向 MUC 的轉變感到非常興奮，而之前我們預計過渡性直通支付狀態到期後的情況將會如此。這對 PYLARIFY 來說顯然是一個好處。但我認為，從更廣泛的角度來看，作為放射性藥物診斷領域的領先者，PYLARIFY 擁有極其強大的產品線，包括 MK-6240、NAV-4694、我們早期開發的 FAB 藥物以及一些即將進行的收購，包括 OCTEVY、Neuroseq 和早期治療診斷對，我認為我們對 MUC 可持續性相關的長期增長潛力、動態支付潛力。

And so I think we think this is a big win. We're naturally going to continue to work with the agency to shift to ASP over time. But I think we're really pleased overall with the market and what this does to the growth and sustainability of the radiopharmaceutical diagnostic space.

所以我認為我們認為這是一個巨大的勝利。我們自然會繼續與該機構合作，隨著時間的推移轉向 ASP。但我認為我們對整個市場以及它對放射性藥物診斷領域的成長和永續性的影響感到非常滿意。

Maybe I'll turn it over to Amanda to talk a little bit more about the competitive dynamics.

也許我會讓阿曼達來進一步談論競爭動態。

Yeah. Thanks, Paul. So as we shared on our commentary during the call that we secured the vast majority of hospital and freestanding imaging centers with multiyear contracts. This will enable us to continue to leverage our strategic partnerships. What I'll say is that I'm very pleased with the evolution of this strategy and the partnerships. We expect to continue to capitalize on PYLARIFY's clinical and commercial differentiation to support its clear market leadership and pricing premium even with the current competitive market dynamics.

是的。謝謝，保羅。因此，正如我們在電話會議中所評論的那樣，我們透過多年合約獲得了絕大多數醫院和獨立影像中心的青睞。這將使我們能夠繼續利用我們的策略夥伴關係。我想說的是，我對這項策略和合作關係的演變感到非常高興。我們希望繼續利用 PYLARIFY 的臨床和商業差異化來支持其明顯的市場領導地位和定價溢價，即使在當前競爭激烈的市場環境下也是如此。

So just kind of talking a little bit more about our commercial differentiation and our clinical differentiation from a commercial differentiation perspective, we have the largest dedicated commercial team. Additionally, we have broad payer access with more than 90% of lives having access to PYLARIFY. We have a longer half-life, which is a distribution advantage, and that enables us to optimize on our multipartner manufacturing facility network. This makes PYLARIFY widely available through a diverse supply chain, ensuring convenient and reliable supply in over 48 states.

因此，從商業差異化的角度來談談我們的商業差異化和臨床差異化，我們擁有最大的專門商業團隊。此外，我們擁有廣泛的付款人存取權限，超過 90% 的人可以使用 PYLARIFY。我們的半衰期更長，這是一種分銷優勢，使我們能夠優化我們的多合作夥伴製造設施網路。這使得 PYLARIFY 能夠透過多樣化的供應鏈廣泛普及，確保在 48 個州內實現便捷可靠的供應。

And then from a clinical differentiation perspective, there's really three things. There's clarity from a diagnostic perspective, meaning accurate detection rate without the high false positive rate. We have clarity in intended patient management, which is based on robust pivotal clinical data and clarity from consistency and reader interpretation or high inter-reader agreement. So by driving differentiation through clinical and commercial differentiation, our long-term strategic partnerships and an optimal customer experience, we plan to continue to grow PYLARIFY both in volume and net sales in 2025.

從臨床鑑別的角度來看，其實有三件事。從診斷角度來看，它很清晰，意味著檢測率準確，但假陽性率卻不高。我們對預期的患者管理有明確的認識，這是基於強大的關鍵臨床數據以及一致性和讀者解釋或讀者間高度一致性的清晰度。因此，透過臨床和商業差異化、我們的長期策略合作夥伴關係和最佳客戶體驗來推動差異化，我們計劃在 2025 年繼續實現 PYLARIFY 的銷售和淨銷售額的成長。

Richard Newitter, Truist Securities.

Truist Securities 的 Richard Newitter。

Just maybe on PYLARIFY, any color you can provide on the cadence and pacing of the PYLARIFY growth within that low single digit to mid-single digit. And specifically, in the first half of the year, should we expect PYLARIFY to grow in all quarters, including the first quarter?

也許只是在 PYLARIFY 上，您可以提供關於 PYLARIFY 在低個位數到中個位數範圍內增長的節奏和速度的任何顏色。具體來說，在上半年，我們是否應該預期 PYLARIFY 在包括第一季在內的所有季度都會成長？

So Rich, I'll take that. So I think that our guidance actually kind of has captured sort of a range of different scenarios. Toward the low end, I think you would expect sort of a flattish first half with modest growth in the second half. That's how you get to that sort of the low end of the range. That piece of consideration is sort of anniversarying as we go through the strategic partnerships as more of those contracts actually come into full sort of value, if you will. But if you think towards the higher end of the range, really what that does imply, yes, is growth in the first half of the year, actually increasing to sort of the mid-single, high single-digit kind of growth in the back half of the year.

那麼 Rich，我接受。所以我認為我們的指導實際上已經涵蓋了一系列不同的場景。對於低端而言，我認為你會預期上半年會比較平穩，下半年會適度成長。這就是你如何達到這種範圍的低端。當我們進行策略合作時，這種考慮就像是周年紀念，因為更多的合約實際上已經達到了全部價值，如果你願意的話。但如果你考慮範圍的高端，這確實意味著，是的，上半年的成長實際上會增加到下半年的中等個位數、高個位數的成長。

So the scenario is going to capture like a very nice growth profile no matter where we are in the whole thing and sort of is very reflective of the hard work that the commercial team has done to get these strategic partnerships put in place.

因此，無論我們處於整個過程中的哪個階段，這種情況都將呈現出非常好的成長態勢，並且在一定程度上反映了商業團隊為建立這些策略夥伴關係所做的努力。

Paul Choi, Goldman Sachs.

高盛的保羅·崔（Paul Choi）。

My question is on Flyrcado. And just as you're thinking about the partnership with your partnership there, can you maybe just update us on what are the inputs that are involved in the decision process of potentially going forward with the co-promote here and just kind of what has been the sort of rate-limiting step from Lantheus perspective.

我的問題是關於 Flyrcado 的。就像您正在考慮與那裡的合作夥伴建立合作關係一樣，您能否向我們介紹一下在決策過程中可能繼續進行共同推廣的投入，以及從 Lantheus 的角度來看，這是一種什麼樣的限速步驟。

Yeah, Paul, I appreciate the question. At this time, we're not anticipating entering into the co-promote option with GE. They're more than capable of achieving their ambition and we're here to support them if they need it.

是的，保羅，我很感謝你的提問。目前，我們還沒有計劃與通用電氣達成共同推廣協議。他們完全有能力實現自己的抱負，如果他們需要的話，我們也會支持他們。

Matt Taylor, Jefferies.

馬特泰勒，傑富瑞。

I wanted to go back to, I think it was Paul, before was talking about the potential for CMS to go to an ASP-based methodology and all the folks now reporting that. Can you talk about the potential for that to happen this year versus next year? And if that does happen for PYLARIFY, how do you think that changes your growth potential for PYLARIFY in '26 or '27 if it changes?

我想回顧一下，我認為是保羅，之前他正在談論 CMS 轉向基於 ASP 的方法的可能性，現在所有人都在報告這一點。您能談談今年和明年發生這種情況的可能性嗎？如果 PYLARIFY 確實出現這種情況，您認為這會對 PYLARIFY 在 26 年或 27 年的成長潛力產生什麼影響？

Paul, you want to do that? Or do you want me to --

保羅，你想這麼做嗎？或者你想讓我--

I'll help you tag team it.

我會幫助你們組隊。

Great. So it is a little hard to predict what's going to be happening down within the Beltway as you know. So hopefully, the doors will stay open. But look, if they migrate to ASP, we look at that as upside to the business. It's that simple. Paul?

偉大的。因此，如您所知，很難預測環城公路內會發生什麼。所以希望大門能夠繼續敞開。但是，如果他們遷移到 ASP，我們認為這對業務有利。就這麼簡單。保羅？

I think that's spot on. I think the CMS will continue to establish draft rules this summer in July. Then they come out and collect comments throughout the fall. They come out with final rules, proposed rules in the November timeframe to take effect in '26. So Matt, just to be specific, I think the earliest we could potentially see this is Jan 1 '26, but we would see those draft rules in July.

我認為這是完全正確的。我認為 CMS 將在今年夏天 7 月繼續制定規則草案。然後他們在整個秋季出來收集評論。他們將在今年 11 月出台最終規則和擬議規則，這些規則將於 26 年生效。所以馬特，具體來說，我認為我們最早可能在 26 年 1 月 1 日看到這一點，但我們會在 7 月看到這些規則草案。

I think CMS remains open to adjusting for ASP. Clearly, that requires the industry to report ASP for the vast majority of products that would be subject to the separate payment status. Our base case is for in '25 and beyond. And if we received ASPs, that would just further support the payment dynamics of the overall PSMA PET diagnostics. So guidance and our expectations are based on MUC for the full year of '25.

我認為 CMS 仍願意調整 ASP。顯然，這要求業界報告絕大多數需要單獨付款的產品的平均售價。我們的基本預測是 25 年及以後。如果我們收到 ASP，那將進一步支援整體 PSMA PET 診斷的支付動態。因此，我們的指導和預期是基於 25 年全年的 MUC。

Yuan Zhi, B. Riley.

袁志，B.Riley。

Although PYLARIFY will be paid in separate payments after this pass-through expired in January, the reimbursement price is lower than competitors. I heard some customers are raising from PYLARIFY through MUCs or possibly in 4Q before the CMS policy update. I'm curious to hear how these ratio and dynamics have played out recently.

儘管在一月份此項轉嫁到期後，PYLARIFY 將以單獨付款的方式支付，但報銷價格低於競爭對手。我聽說一些客戶正在透過 MUC 從 PYLARIFY 籌集資金，或者可能在 CMS 政策更新之前的第四季度籌集資金。我很好奇這些比例和動態最近是如何發展的。

So I'll tag team that with Amanda. But as you heard us repeatedly, our strategic contracts are in place with the vast majority of our customers, and that strategy was set in motion over a year ago. And so we're very comfortable and it anticipated essentially no change to any of the rules. So the fact that we have an MUC and have a separate payment is really upside to what we were originally thinking and planning, and we never changed our strategy and tactics all the way through. So while it's true that the competition is trying to nibble at the borders, we've kept the wall up. So Amanda, anything you want to add to that?

所以我會和阿曼達一起組隊。但正如您反覆聽到的那樣，我們已經與絕大多數客戶簽訂了戰略合同，並且該戰略已於一年前開始實施。因此我們非常放心，預計任何規則基本上都不會改變。因此，我們擁有 MUC 並單獨付款的事實確實對我們最初的想法和計劃有利，而且我們從未改變過我們的策略和策略。因此，儘管競爭對手確實試圖蠶食邊境，但我們仍然保留了隔離牆。那麼阿曼達，您還有什麼要補充的嗎？

Yeah. What I'll add is -- listen, it's a complex market, right? There's different factors in here in play here from the commercial differentiation that I talked about the clinical differentiation, but there's also an availability piece, right? And so that does have an important kind of piece of how this market plays their select markets where there is limited access to PYLARIFY in early mornings or late afternoon. And we'll continue to build that through our PMS network and expanding our manufacturing time slots.

是的。我想補充的是——聽著，這是一個複雜的市場，對吧？這裡起作用的因素與我之前談到的商業差異化和臨床差異化有所不同，但也存在可用性因素，對嗎？因此，這確實對這個市場如何發揮其特定市場的作用具有重要意義，在這些市場中，清晨或傍晚對 PYLARIFY 的訪問有限。我們將繼續透過我們的 PMS 網路建立這一點並擴大我們的製造時間段。

But really, I would just go back to kind of what we hear from accounts and that is they prefer F18 when it's available, and we've done a fantastic job of getting patients access to clarify getting accounts access to PYLARIFY. And then just as Brian shared, really through our strategic partnerships. We really have been able to, as we shared, really secure a vast majority of our hospitals and freestanding imaging centers.

但實際上，我只是想回顧一下我們從帳戶中聽到的情況，那就是當 F18 可用時，他們更喜歡它，而且我們在讓患者訪問 PYLARIFY 方面做得非常出色。正如 Brian 所分享的，這確實透過我們的策略合作夥伴關係實現。正如我們所分享的，我們確實能夠確保絕大多數醫院和獨立影像中心的安全。

Yeah. And the other thing to note is our service statistics and customer support, along with our PMF partnerships is just outstanding. So appreciate the question. We'll lock and load it.

是的。另外值得注意的是，我們的服務統計數據和客戶支援以及我們的 PMF 合作夥伴關係非常出色。非常感謝你的提問。我們將全力以赴。

Larry Solow, CJS Securities.

索洛（Larry Solow），CJS 證券公司。

I guess I just wanted to just follow up on Richard's question just on the cadence of the year. I guess, we can infer that the impact of price, obviously, is waning in the back half. So my question is kind of what does that mean as we look out to '26? Should we actually expect -- given the to '26. But long term, this should sound like it's a 1-year reset. Should we expect kind of price to at least not be a headwind as we look out into '26? And the second part of that question is just, I don't know if you can give us a little more concrete numbers here, but it felt like the price impact in the back half of this year or Q4 was pretty muted. So I assume there will be some impact, right, going forward, at least in the front half of the year.

我想我只是想跟進理查德關於今年節奏的問題。我想，我們可以推斷，價格的影響在後半年顯然正在減弱。所以我的問題是，當我們展望 26 年時，這意味著什麼？我們是否應該真正期待——考慮到 26 年。但從長遠來看，這聽起來像是一年一次的重置。當我們展望 26 年時，我們是否應該預期這種價格至少不會成為阻力？問題的第二部分是，我不知道您是否可以給我們更具體的數字，但感覺今年下半年或第四季度的價格影響相當小。所以我認為至少在上半年會產生一些影響。

Yeah, Larry, thanks for that question. I think your assessment is right that this year 2025 is going to be more reflective of the price dynamics as we anniversary through the strategic contracting with our partners. And so the normal seasonality, if you will, isn't necessarily going to be reflective within the PYLARIFY franchise. We will see seasonality that we normally see with the DEFINITY, for instance. But as we look into 2026, as we anniversary through, yeah, we do have a sense of bringing those sort of foundational products in PYLARIFY and DEFINITY back to more of a seasonally cadence sort of flow, if you will, of revenue stream.

是的，拉里，謝謝你的提問。我認為您的評估是正確的，隨著我們與合作夥伴簽訂策略合約週年紀念，2025 年將更能反映價格動態。因此，如果你願意的話，正常的季節性不一定會在 PYLARIFY 特許經營中得到反映。例如，我們將看到通常在 DEFINITY 中看到的季節性。但當我們展望 2026 年，當我們走過週年紀念日時，是的，我們確實有一種感覺，將 PYLARIFY 和 DEFINITY 中的那些基礎產品帶回更具季節性節奏的收入流中。

Maybe just to add, Larry, on the specific kind of pricing dynamics. In the second half of '24, we did see sequential declines. If you look at the first half of '24 pricing and you look at the second half of '24 pricing from an actual realized, we did see a decline. Now that's with the overall raising prices and others that helps offset some of those. But that will normalize, as Bob has mentioned, as we get to the second half of '25 because those year over year comps are now included in that. We did take a mid-single-digit price increase at the beginning of '24. We highlighted that we did the same slightly earlier in '25 this year.

拉里，也許只是想補充一下具體類型的定價動態。在 2024 年下半年，我們確實看到了連續的下滑。如果您看一下 24 年上半年的定價，再看一下 24 年下半年的實際定價，我們確實看到了下降。現在，整體價格上漲，其他因素也有助於抵消其中的一些影響。但正如鮑勃所提到的那樣，隨著我們進入 25 年下半年，這種情況將會正常化，因為同比數據現在已包含在內。在 2024 年初，我們確實實現了中等個位數的價格上漲。我們強調，我們在今年 25 年初就做了同樣的事情。

Justin Walsh, JonesTrading.

賈斯汀·沃爾什（Justin Walsh），JonesTrading。

You noted Neuroseq is expected to expand your international footprint. Do you have broader ex US commercial plans for your pipeline assets? And to what degree do you anticipate remaining US focused in the long term?

您指出 Neuroseq 有望擴大您的國際影響力。您是否針對您的管道資產制定了更廣泛的美國以外的商業計劃？您預計長期內將在多大程度上繼續關注美國？

I think our focus really is US-based right now. Neuroseq, and once we close on Life Molecular Imaging, it will give us a much stronger international footprint. We certainly want to stop relying on out-licensing our assets. So I think we're going to look very carefully at expanding into the other markets, particularly the EU. However, we're not going to do a greenfield exercise where we're going to pour a lot of money into something and then hope we can fill it up. So it's going to be opportunity based. And I think the stronger portfolio gives us a real reason to be there. But as we look at the company today, we're US focused.

我認為我們現在的重點確實是在美國。Neuroseq，一旦我們完成生命分子成像，它將為我們提供更強大的國際影響力。我們當然希望不再依賴對外授權我們的資產。因此我認為我們將非常謹慎地考慮向其他市場擴張，特別是歐盟。然而，我們不會進行“綠地計劃”，即投入大量資金，然後希望能夠將其填滿。所以這將基於機會。我認為更強大的投資組合給了我們進入該市場的真正理由。但當我們今天審視這家公司時，我們的重點是美國。

Andy Hsieh, William Blair.

安迪謝、威廉布萊爾。

I'm curious if you can comment on your strategy in building the data set that highlights the competitive differentiation for MK-6240 and NAV-4694, as you get ready for the regulatory submissions of these two assets.

我很好奇，當您準備提交這兩項資產的監管文件時，您是否可以評論您建立資料集的策略，該資料集突出了 MK-6240 和 NAV-4694 的競爭差異。

Yeah, it's a great question. And I think there was the annual amyloid conference in Puerto Rico in January, which seems like ages ago. And the quality and amount of information on MK-6240, was really quite substantial and data coming out of the head study in Pittsburgh, which is a federally funded trial, where basically they're comparing all the tau agents and all the tracers in AD, demonstrated a significant advantage for MK-6240 over any of the other tau tracers, whether they're in development or on the market today.

是的，這是一個很好的問題。我記得一月在波多黎各舉行了年度澱粉樣蛋白會議，這似乎是很久以前的事了。MK-6240 的資訊品質和數量確實相當可觀，匹茲堡主要研究得出的數據（這是一項聯邦政府資助的試驗）基本上比較了 AD 中的所有 tau 藥物和所有示踪劑，結果顯示 MK-6240 比任何其他 tau 示踪劑（無論它們是在開發中還是目前已上市）都具有顯著優勢。

So we feel that MK-6240 is already recognized as an extraordinary asset for its ability to detect early tau tangles. And the evidence of that is very clear as well because it's in over 100 clinical trials right now, most of vast majority academic, but we have some real interesting partnerships already in place and developing with major pharma like J&J, like Merck and others and Roche to really be the diagnostic agent for their assets in development, and we're very excited about that.

因此，我們認為 MK-6240 已經因其檢測早期 tau 纏結的能力而被認可為非凡的資產。這方面的證據也非常明確，因為目前已有 100 多個臨床試驗，其中絕大多數是學術性的，但我們已經與強生、默克等主要製藥公司以及羅氏建立了一些真正有趣的合作夥伴關係，並正在發展中，真正成為他們正在開發的資產的診斷代理，我們對此感到非常興奮。

NAV is a little bit further behind. But again, NAV as a beta amyloid is seeming to shape up quite similarly to MK in its ability to detect very early or low centiloid counts. And I might add both of these agents, while not as convenient as a blood test, may turn out to be more sensitive than a blood test. We're certainly seeing that pan out right now with MK-6240. That doesn't mean it would ever replace it because the blood test is inexpensive and so cheap. However, looking at some data versus pTau and MK-6240, the tracers have a distinct advantage right now, our tracers anyway. Thanks.

NAV 稍微落後一點。但是，NAV 作為一種 β 澱粉樣蛋白，在檢測非常早期或較低的中心體計數的能力方面似乎與 MK 非常相似。我想補充一點，這兩種檢測方法雖然不如血液檢測方便，但可能比血液檢測更敏感。我們現在確實看到 MK-6240 實現了這一點。但這並不意味著它會取代它，因為血液檢查很便宜。然而，與 pTau 和 MK-6240 相比，示踪劑目前具有明顯的優勢，無論如何，我們的示踪劑都是如此。謝謝。

John Vandermosten, Zacks.

約翰·范德莫斯滕，Zacks。

As you mentioned before you acquired two assets from Radiopharm Theranostics and that was the 2403 and 2404. First question is, what's the -- are those completely under your control right now? And then the second part is you have a significant investment in them as well. And they have a pretty large portfolio and a presence in Australia. Does anything else look attractive at that company for you?

正如您之前提到的，您從 Radiopharm Theranostics 收購了兩項資產，即 2403 和 2404。第一個問題是，這些現在完全在你的掌控之下嗎？第二部分是你對他們也做了大量投資。他們在澳洲擁有相當大的投資組合和業務。該公司還有其他吸引你的地方嗎？

Yeah. Number one, the answer to 100% control of the assets is yes. And number two, the whole company does look interesting. They've got a very nice portfolio in development. But our significant investment is really not that big in reality. It's kind of a foot in the door to stay close to them and support them. And we're going to stay close to them. We like the management team. We like what they're trying to do, and we want them to be successful. And if more reasons evolve to partner, we'll continue to do so. but we are leveraging their capabilities right now as we march along with LRRC15 and get it into the clinic.

是的。第一，對於100%控制資產，答案是肯定的。第二，整個公司看起來確實很有趣。他們正在開發非常出色的產品組合。但實際上我們的重大投資並沒有那麼大。這是一種與他們保持密切聯繫並支持他們的敲門磚。我們將與他們保持密切聯繫。我們喜歡這個管理團隊。我們喜歡他們正在嘗試做的事情，我們希望他們能夠成功。如果有更多理由尋求合作，我們將繼續這樣做。但我們正在利用他們的能力，與 LRRC15 一起前進並將其帶入臨床。

Kemp Dolliver, Brookline Capital Markets.

布魯克林資本市場 (Brookline Capital Markets) 的 Kemp Dolliver。

I want to ask about PNT2002 in the context of the PSMAfore final hazard ratio coming out of 0.91, I know we're still waiting for your final HR data, but it strikes me that with that as the competitive bar that 2002's prospects may look pretty appealing now.

我想問一下在 PSMA 的背景下 PNT2002 的情況，最終風險比為 0.91，我知道我們仍在等待您的最終 HR 數據，但我認為，以此作為競爭標準，2002 年的前景現在看起來可能相當有吸引力。

Yeah. Thanks for the question. I think when you look at the population pre-chemo for 2002 as well as Pluvicto, we were underdosed in our trial, the cycles were a little further apart. And we had a suboptimal overall survival hazard ratio, which may not improve. So while the safety, the efficacy of the product is there, from our ability to get it approved by the FDA, we're not that confident. So we're going to just wait for the study to read out, see where we go and then determine if we have a play. So we're just going to learn as we go and see how it goes. But right now, we are not expecting an FDA approval for 2002 in the near future.

是的。謝謝你的提問。我認為，當你查看 2002 年化療前的人群以及 Pluvicto 時，我們在試驗中劑量不足，週期間隔稍長。我們的整體生存風險比不理想，而且可能不會改善。因此，儘管該產品的安全性和有效性是毋庸置疑的，但從我們獲得 FDA 批准的能力來看，我們並不那麼有信心。因此，我們只需等待研究結果出來，看看我們能取得什麼進展，然後確定我們是否有行動。因此，我們只是邊走邊學，看看進展如何。但目前，我們並不指望 FDA 近期批准 2002 年的方案。

Richard Newitter, Truist Securities.

Truist Securities 的 Richard Newitter。

I just -- I wanted to ask the low single-digit to mid-single-digit PYLARIFY growth guide. Can you just talk to what your underlying market growth assumption is, or what the trend will look like in '25 to get there?

我只是——我想問一下低個位數到中個位數的 PYLARIFY 成長指南。您能否談談您對市場成長的基本假設是什麼，或者 25 年實現這一目標的趨勢會是什麼樣的？

So I think, Rich, we continue to see growth potential in the PSMA PET market, certainly double-digit growth when we see that. We are very focused on maintaining our leadership and our share position. I think what you're seeing is the natural seasonality across quarters that Bob has alluded to many times before, and then the gross to net compression given the roll in of our strategic partnerships.

因此，我認為，Rich，我們繼續看到 PSMA PET 市場的成長潛力，當我們看到這一點時，肯定會出現兩位數的成長。我們非常注重維持我們的領導地位和份額地位。我認為您所看到的是鮑勃之前多次提到的各個季度的自然季節性，以及由於我們的戰略合作夥伴關係的實施而產生的總額到淨額的壓縮。

And so the overall market remains strong. We are focused on maintaining our revenue share going forward and maintaining PYLARIFY as the clear market leader. And so growth will not be sequentially the same every year or even every quarter as additional data comes out, and so we believe in the long-term potential. And we believe that PYLARIFY will maintain its leadership and its revenue share position.

因此整體市場依然保持強勁。我們專注於保持未來的收入份額並保持 PYLARIFY 作為明顯的市場領導者。因此，隨著更多數據的公佈，每年甚至每季的成長都不會是連續相同的，因此我們相信長期潛力。我們相信 PYLARIFY 將保持其領導地位和收入份額地位。

Yeah. The only thing I would add to that, Paul, is that obviously, that the guide is -- we're trying to do it on a net basis because that's what ultimately gets recorded. And we're really pleased that we are growing the franchise. It's a $1 billion franchise with a very nice margin profile. It's going to help us to generate that $550 million to $600 million of free cash flow, which is now -- I have been telling people that it was about $125 million on average, that number goes up to about $140 million on average.

是的。保羅，我唯一要補充的是，顯然，指南是——我們試圖在網路基礎上進行，因為這才是最終被記錄下來的內容。我們非常高興我們的特許經營業務正在不斷擴大。這是價值 10 億美元的特許經營權，利潤率非常高。它將幫助我們產生 5.5 億至 6 億美元的自由現金流，現在——我一直告訴人們，平均約為 1.25 億美元，這個數字平均上升到約 1.4 億美元。

Can you say that again?

你能再說一次嗎？

$550 million to $600 million of free cash flow.

5.5億至6億美元的自由現金流。

This year?

今年？

This year. So I mean that's ultimately the benefit because that's going to help us to drive our long-term growth profile of the company.

今年。所以我的意思是這最終是有好處的，因為這將幫助我們推動公司的長期成長。

David Turkaly, Citizens JMP.

David Turkaly，公民 JMP。

I apologize, I have been bouncing around a little bit. But I thought I heard a comment early on that sustained double-digit growth could begin again in 2026. And I was just wondering, is that based on sort of the current core like PYLARIFY and DEFINITY, or are there some assets in the pipeline there that you're comfortable with that will be contributing by that? And if so, could you maybe point to which ones would deliver that kind of a profile.

抱歉，我最近有點忙不過來。但我記得我早些時候聽過這樣的評論：2026 年可能會再次開始持續的兩位數成長。我只是想知道，這是基於當前的核心，例如 PYLARIFY 和 DEFINITY，還是其中有一些您認為可以做出貢獻的資產？如果是的話，您能否指出哪些可以提供這種類型的資料？

Right. Yes. No, great question, and I'm glad you asked it. So we certainly anticipate PYLARIFY to lead the way, and DEFINITY. There's no question in our mind there at this time. Also, we have 2003 in the pipeline And pending closing of LMI and Evergreen Life Molecular Imaging, we will look to add Neuroseq which we're very excited about. And OCTEVY, the theranostic pair, to 2003, which is in our pipeline. So we're looking at potentially three brand-new launches next year that will lead to our growth profile, the addition of Neuroseq and that will pop us into double-digit growth. But I want to underscore, led by PYLARIFY.

正確的。是的。不，這個問題問得好，我很高興你問了這個問題。因此，我們當然期待 PYLARIFY 和 DEFINITY 能夠引領潮流。目前我們心中沒有任何疑問。此外，我們還有 2003 年的計劃，在 LMI 和 Evergreen Life Molecular Imaging 即將關閉之前，我們將考慮添加 Neuroseq，對此我們感到非常興奮。2003 年，OCTEVY（一種治療診斷組合）已進入我們的研發線。因此，我們預計明年將推出三款全新產品，這將提升我們的成長前景，而 Neuroseq 的加入將使我們實現兩位數的成長。但我想強調的是，由 PYLARIFY 領導。

Thank you. Ladies and gentlemen, there are no further questions at this time. Thank you for participating in today's conference. This concludes the program. You may disconnect, and have a wonderful day.

謝謝。女士們、先生們，現在沒有其他問題了。感謝大家參加今天的會議。本節目到此結束。您可以斷開連接並度過美好的一天。