Lantheus Holdings Inc (LNTH) 2024 Q3 法說會逐字稿

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

早安.歡迎參加 Lantheus 2024 年第三季電話會議。（操作員指示）本次通話正在錄音，通話結束後約兩小時，公司網站的「投資者」部分將提供重播，並將存檔至少 30 天。

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

現在我將把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.

謝謝。早安.

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

今天和我一起的是我們的執行長 Brian Markison；我們的總裁 Paul Blanchfield；我們的財務長 Bob Marshall；我們的首席醫療官 Jeff Humphrey；以及我們的首席商務官阿曼達摩根（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 third-quarter 2024 results. The release and today's slide presentation are 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，報告了我們的 2024 年第三季業績。該發布和今天的幻燈片演示都位於我們網站的投資者部分。

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.

所發表的任何評論都可能包含前瞻性陳述。由於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，這些風險和不確定性在我們提交給美國證券交易委員會的文件中詳細說明。

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.

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 財務指標的對帳表已包含在我們網站的「投資者」部分中。

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.

謝謝你，馬克，大家早安。

Lantheus is the leading radiopharmaceutical-focused company with market-leading commercial products and a growing radiopharmaceutical pipeline targeting areas of significant unmet need. In the third quarter, we continued to enhance our leadership and create long-term sustainable growth through operational excellence, financial discipline, and prudent capital deployment.

Lantheus 是一家領先的專注於放射性藥物的公司，擁有市場領先的商業產品和不斷增長的放射性藥物產品線，針對尚未滿足的重大需求領域。第三季度，我們透過卓越的營運、財務紀律和審慎的資本配置，持續增強領導地位並創造長期永續成長。

PYLARIFY, our PSMA PET imaging agent, delivered solid performance and remains on track to reach blockbuster status in 2024. And DEFINITY, our ultrasound-enhancing agent, grew double digits year over year. The continued success of these flagship diagnostic agents enables us to invest both organically and inorganically in our pipeline to extend our radiopharmaceutical leadership and create long-term value for shareholders.

我們的 PSMA PET 造影劑 PYLARIFY 表現穩健，預計在 2024 年達到重磅藥物的地位。我們的超音波增強劑 DEFINITY 的銷量比去年同期成長了兩位數。這些旗艦診斷藥物的持續成功使我們能夠在我們的產品線中進行有機和無機投資，以擴大我們在放射性藥物領域的領導地位並為股東創造長期價值。

Before we move on to review the quarter, I'd like to commend CMS for its landmark decision to pay separately for specialized diagnostic radiopharmaceuticals beginning January 1, 2025. Under the hospital's outpatient prospective payment system, or OPPS, rule, this is a significant win for patient access and will ensure specialized diagnostic radiopharmaceuticals, including PYLARIFY, are accessible for Medicare fee-for-service patients going forward while also supporting long-term innovation in the field, including potentially MK-6240 and NAV-4694, our late-stage diagnostic product candidates for Alzheimer's disease.

在我們繼續回顧本季之前，我想讚揚 CMS 做出的具有里程碑意義的決定，即從 2025 年 1 月 1 日起單獨支付專門診斷放射性藥物的費用。根據醫院的門診預付費系統 (OPPS) 規則，這是患者獲得治療的重大勝利，並將確保包括 PYLARIFY 在內的專業診斷放射性藥物今後可供醫療保險按服務收費患者使用，同時也支持長期創新該領域的潛力包括MK-6240 和NAV-4694，這是我們針對阿茲海默症的後期診斷產品候選者。

With that, I'll now turn the call over to Paul to provide an operational update.

說完這些，我現在將電話轉給保羅，讓他提供營運更新資訊。

Thank you, Brian. I'm pleased today to share progress on our commercial portfolio and pipeline.

謝謝你，布萊恩。今天我很高興與大家分享我們的商業組合和管道的進展。

PYLARIFY sustained its clear market leadership as the number one PSMA PET imaging agent and remained on track to grow mid-20% year over year in 2024 and reach blockbuster status with more than $1 billion in sales. Net sales for the quarter were approximately $260 million, up 20% year over year and down 5% sequentially. Year-over-year growth was driven by increasing volumes, offset slightly by net price as we secured strategic partnerships.

PYLARIFY 作為第一大 PSMA PET 成像劑，保持了明顯的市場領先地位，並有望在 2024 年實現同比增長 20% 左右，並達到銷售額超過 10 億美元的重磅藥物地位。本季淨銷售額約 2.6 億美元，年增 20%，季減 5%。同比成長主要得益於銷售成長，但由於我們獲得了策略合作夥伴關係，淨價略微抵消了這一成長。

Sequentially, the overwhelming majority of our existing accounts grew along with the PSMA PET market. The sequential revenue decline was driven by traditional third-quarter seasonality, the net price impact of our recently secured strategic partnerships, as well as intentional tradeoffs largely due to product availability.

隨後，我們現有的絕大多數帳戶隨著 PSMA PET 市場的發展而成長。連續的收入下降是由於傳統的第三季季節性因素、我們最近達成的策略合作夥伴關係的淨價格影響、以及主要由於產品可用性而做出的有意權衡。

We continue to secure strategic partnerships with hospitals and freestanding imaging centers and believe our ability to maintain a price premium versus that of our competition reflects the commercial and clinical value that PYLARIFY provides to our customers. We believe we are well positioned to continue as the clear market leader in PSMA PET imaging and sustain PYLARIFY as $1 billion franchise in 2025.

我們繼續與醫院和獨立影像中心建立策略合作夥伴關係，並相信我們能夠保持比競爭對手更高的價格，這反映了 PYLARIFY 為客戶提供的商業和臨床價值。我們相信，我們有能力繼續成為 PSMA PET 影像領域的明顯市場領導者，並在 2025 年將 PYLARIFY 維持在 10 億美元的特許經營權價值。

As Brian mentioned, we are very pleased with CMS's updated rule recognizing the value and need for broad access to innovative diagnostic radiopharmaceuticals, including PYLARIFY. The rule provides separate payment for diagnostic radiopharmaceuticals, with per-day costs greater than $630 following the expiry of transitional pass-through payment status. This represents significant progress for the field of diagnostic radiopharmaceuticals and, most importantly, sustained patient access.

正如 Brian 所提到的，我們對 CMS 更新的規則感到非常高興，該規則承認了廣泛使用創新診斷放射性藥物（包括 PYLARIFY）的價值和必要性。該規則規定，診斷放射性藥物需單獨付費，過渡性轉付費用狀態到期後，每天的費用將超過 630 美元。這代表診斷放射性藥物領域取得了重大進展，最重要的是，可持續的患者獲得治療。

When implemented on January 1, 2025, CMS will maintain separate payment for PYLARIFY for the approximately 20% of patients with traditional Medicare fee-for-service insurance coverage who are treated in the hospital outpatient setting. PYLARIFY's calendar year 2025 payment rate is found in Addendum B and is the same as its current payment rate. Note that this is in addition to the PET-CT procedural payment. We will be working with our customers to ensure they understand the final rule and recognize the value that PYLARIFY does and will continue to offer to the prostate cancer community.

當 2025 年 1 月 1 日實施時，CMS 將為在醫院門診接受治療的約 20% 擁有傳統醫療保險按服務收費保險的患者單獨支付 PYLARIFY 費用。PYLARIFY 的 2025 日曆年的支付率可以在附錄 B 中找到，與其目前的支付率相同。請注意，這是 PET-CT 程序付款以外的費用。我們將與客戶合作，確保他們了解最終規則並認識到 PYLARIFY 為前列腺癌社群提供的價值並將繼續提供這些價值。

In our cardiology franchise, DEFINITY delivered third-quarter net sales of $77 million, increasing 14% year over year. This was slightly higher than expected as competitors' supply challenges led to higher market share that was in addition to high-single-digit year-over-year market growth. DEFINITY's long-term success remains driven by its proven clinical and commercial value, long-standing track record of clinical application, and our ongoing operational excellence.

在我們的心臟病學特許經營中，DEFINITY 第三季淨銷售額為 7,700 萬美元，年增 14%。這一數字略高於預期，因為競爭對手的供應挑戰導致了更高的市場份額，此外市場同比增長率也達到了高個位數。DEFINITY 的長期成功仍然得益於其經過驗證的臨床和商業價值、長期的臨床應用記錄以及我們持續的卓越營運。

We are also pleased by the FDA's approval of FLYRCADO, also known by its generic name flurpiridaz, which we outlicensed to GE Healthcare in 2017. FLYRCADO is an F18 radio tracer approved for enhanced diagnosis of coronary artery disease. GE Healthcare has global commercialization rights and will lead the US launch. Lantheus will receive royalties based on commercial milestones.

我們也很高興 FDA 批准了 FLYRCADO（其通用名也稱為 flurpiridaz），我們於 2017 年將其授權給了 GE Healthcare。FLYRCADO 是一種 F18 放射性追蹤劑，經批准可用於增強冠狀動脈疾病的診斷。GE醫療集團擁有全球商業化權利並將主導美國的上市。Lantheus 將根據商業里程碑獲得版稅。

We are also excited about MK-6240 and NAV-4694, our next-generation late-stage tau and beta amyloid radio diagnostics, and believe they can play a meaningful role in the diagnosis, staging, and monitoring of Alzheimer's disease. We expect these agents to be differentiated due to their high affinity and low off-target binding, potentially allowing for clearer images and earlier detection of disease.

我們也對下​​一代後期 tau 和 β 澱粉樣蛋白放射診斷技術 MK-6240 和 NAV-4694 感到興奮，並相信它們可以在阿茲海默症的診斷、分期和監測中發揮重要作用。我們期望這些藥物能夠因其高親和力和低脫靶結合而有所區別，從而有可能獲得更清晰的圖像並更早發現疾病。

MK-6240 is a tau PET tracer for Alzheimer's disease currently utilized in 119 ongoing academic and industry-sponsored clinical trials. The dynamic range of MK-6240 may represent an advantage for longitudinal assessments of tau progression or treatment response, in which detecting small changes can be critical. Tau pathology is closely linked to symptom severity, rate of decline, and development of declines in visiospatial and language functions.

MK-6240 是一種用於治療阿茲海默症的 tau PET 追蹤劑，目前正在進行 119 項由學術和產業贊助的臨床試驗中使用。MK-6240 的動態範圍可能代表對 tau 進展或治療反應的縱向評估的優勢，其中檢測微小的變化至關重要。Tau 病理與症狀的嚴重程度、衰退速度以及視覺空間和語言功能衰退的發展密切相關。

NAV-4694 has low non-specific white matter binding and high sensitivity, which suggests it could be useful for early detection of beta amyloid accumulation. We believe earlier detection may aid in the identification of those Alzheimer's patients most likely to realize a therapeutic benefit. Like MK-6240, NAV-4694 is currently being used in both academic and industry-sponsored studies. The National Institute on Aging and the Alzheimer's Association continues to update their guidelines as new therapeutic agents are approved and recently recommended both amyloid and tau PET imaging for diagnosis, staging, and treatment monitoring.

NAV-4694 具有低非特異性白質結合和高靈敏度，這表明它可能有助於早期檢測β澱粉樣蛋白的累積。我們相信早期檢測可能有助於識別最有可能獲得治療益處的阿茲海默症患者。與 MK-6240 一樣，NAV-4694 目前正用於學術界和產業贊助的研究。隨著新治療藥物的批准，美國國家老化研究所和阿茲海默症協會繼續更新其指南，並最近推薦使用澱粉樣蛋白和 tau PET 影像進行診斷、分期和治療監測。

Based on current analysts' forecast of therapeutic uptake and inferred scan volumes, we believe the US market for Alzheimer's radio diagnostics has the potential to reach $1.5 billion by the end of the decade and $2.5 billion by the mid-2030s. We expect to submit NDAs for MK-6240 in 2025 and NAV-4694 in 2026 and are excited to lever our commercial and operational excellence and growing neurological expertise to generate and meet the increasing demand for amyloid and tau PET imaging.

根據目前分析師對治療吸收和推斷掃描量的預測，我們認為美國阿茲海默症放射診斷市場到本世紀末有可能達到 15 億美元，到 2030 年代中期可能達到 25 億美元。我們預計將於2025 年提交MK-6240 的NDA，並於2026 年提交NAV-4694 的NDA，並且很高興利用我們在商業和運營方面的優勢以及不斷增長的神經學專業知識來創造和滿足對澱粉樣蛋白和tau PET 成像日益增長的需求。

Now, I'll turn it back to Brian to discuss the rest of our pipeline.

現在，我將把話題轉回給 Brian，討論我們管道的其餘部分。

Thanks, Paul.

謝謝，保羅。

Our pipeline is focused on assets that have the potential to deliver compelling new approaches for the diagnosis and treatment of disease areas with significant unmet need. Paul covered our neurology program, so I'll discuss our oncology product candidates.

我們的產品線重點關注那些有可能為診斷和治療尚未滿足巨大需求的疾病領域提供引人注目的新方法的資產。保羅介紹了我們的神經病學項目，因此我將討論我們的腫瘤學候選產品。

Within our prostate cancer portfolio, PNT2002 is our investigational PSMA-targeted radiotherapeutic for the treatment of patients with metastatic castrate-resistant prostate cancer. We recently completed the second interim analysis for the Phase III registrational SPLASH study.

在我們的攝護腺癌產品組合中，PNT2002 是我們正在研究的 PSMA 標靶放射治療藥物，用於治療轉移性去勢抵抗性攝護腺癌患者。我們最近完成了第三階段註冊 SPLASH 研究的第二次中期分析。

The analysis was performed at 75% of protocol pre-specified overall survival, or OS, events. The results for both radiographic progression-free survival, or RPFS, and OS have not materially changed from the interim analysis that was performed at 46% of pre-specified OS events. We continue to review the data and perform additional subset analyses with our partner, Eli Lilly, that may be compelling to the FDA in preparation for an interaction on our path forward.

此分析是在方案預先指定的總體存活率 (OS) 事件的 75% 下進行的。放射學無惡化存活期 (RPFS) 和 OS 的結果與 46% 的預定 OS 事件進行的中期分析相比沒有實質變化。我們將繼續與我們的合作夥伴 Eli Lilly 一起審查數據並進行額外的子集分析，這可能對 FDA 具有吸引力，為我們未來的互動做好準備。

As a reminder, the SPLASH study met its primary endpoint of RPFS, which was a meaningful and statistically significant improvement for the PNT2002 arm versus alternate RP or hormone therapy. The OS results and hazard ratio in the ITT population remain confounded by the overwhelming number of patients who crossed over to receive PNT2002.

提醒一下，SPLASH 研究達到了其主要終點即 RPFS，與替代 RP 或荷爾蒙療法相比，這對於 PNT2002 組來說是一個有意義的、具有統計意義的改善。由於絕大多數患者轉而接受 PNT2002 治療，ITT 族群的 OS 結果和風險比仍然令人困惑。

At the recent ESMO meeting, Dr. Oliver Sartor, Lead SPLASH Investigator and Director of Radiopharmaceutical Trials and Professor of Medical Oncology at the Mayo Clinic, highlighted potential benefits of PNT2002 hormone therapy switch. He discussed Pocock analyses and confidence intervals that were adjusted for the crossover population, noting the meaningful benefit from PNT2002 compared to the control arm.

在最近的 ESMO 會議上，SPLASH 首席研究員、放射性藥物試驗主任兼梅奧診所醫學腫瘤學教授 Oliver Sartor 博士強調了 PNT2002 荷爾蒙療法轉換的潛在益處。他討論了針對交叉人群進行調整的 Pocock 分析和置信區間，並指出與對照組相比，PNT2002 具有顯著的益處。

We have been focused on enhancing our pipeline by adding additional late-stage and early-stage assets that have the potential to address high unmet medical needs. We continue to work with our partners on our other clinical radiopharmaceutical programs. These include LNTH-2401 and 2402, our RM2 novel theranostic pair targeting gastrin-releasing peptide receptor, or GRPR, for prostate, breast, and other cancers; and LNTH-2403, our LRRC15-targeted radiotherapeutic, for the treatment of osteosarcoma and other solid tumors. I'm particularly excited about these new oncology radiotherapy product candidates because they represent best-in-class constructs aimed at validated targets and have the potential to make a meaningful addition to the treatment options available for patients.

我們一直致力於透過增加額外的後期和早期資產來增強我們的產品線，這些資產有可能滿足大量未滿足的醫療需求。我們將繼續與合作夥伴共同進行其他臨床放射性藥物計畫。其中包括 LNTH-2401 和 2402，這是我們的 RM2 新型治療診斷對，針對胃泌素釋放肽受體或 GRPR，用於治療前列腺癌、乳腺癌和其他癌症；以及我們的LRRC15標靶放射治療藥物LNTH-2403，用於治療骨肉瘤和其他實體腫瘤。我對這些新的腫瘤放射治療產品候選物特別感到興奮，因為它們代表了針對經過驗證的目標的一流構造，並且有可能為患者可用的治療選擇做出有意義的補充。

I will now turn the call over to Bob.

我現在將電話轉給鮑伯。

Thank you, Brian. I will provide highlights of the third-quarter 2024 financials focusing on adjusted results, with comparisons to the prior year quarter, unless otherwise noted.

謝謝你，布萊恩。我將提供 2024 年第三季財務狀況的亮點，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。

Turning to the details, consolidated net revenue for the third quarter was $378.7 million, an increase of 18.4%. Radiopharmaceutical oncology contributed $259.8 million of sales, attributable to PYLARIFY, which was up 20.6%. The result is consistent with seasonal trends, as well as the realization of our strategic partnership efforts.

具體來看，第三季綜合淨營收為3.787億美元，年增18.4%。放射性藥物腫瘤學貢獻了 2.598 億美元的銷售額，這歸功於 PYLARIFY，其增長了 20.6%。此結果與季節性趨勢一致，也符合我們策略夥伴關係努力的實現。

Amidst a competitive environment, as Paul discussed earlier, precision diagnostics revenue of $103.7 million was 7.7% higher. Highlights include sales of DEFINITY at $77 million, 14.3% higher, along with TechneLite revenue of $20.5 million, down 12% due to opportunistic sales in the prior year quarter, not repeated in this year's third quarter, but rather in the second.

正如保羅之前所討論的，在競爭激烈的環境中，精準診斷的收入為 1.037 億美元，成長了 7.7%。亮點包括DEFINITY 的銷售額為7,700 萬美元，成長14.3%，同時TechneLite 的營收為2,050 萬美元，下降12%，原因是去年同期的機會性銷售，而今年第三季並未重複出現這種情況，而是在第二季重複出現。

Lastly, strategic partnerships and other revenue was $15.3 million, up 108.3%, with the RELISTOR royalty stream completely annualized out of the result. Investigational usage of MK-6240 and NAV-4694 contributed $10 million and $2.3 million, respectively. And lastly, we recognized a milestone associated with an out-licensed asset from Progenics.

最後，策略夥伴關係和其他收入為 1,530 萬美元，成長 108.3%，其中 RELISTOR 特許權使用費流已完全從年化結果中扣除。MK-6240 和 NAV-4694 的研究用途分別貢獻了 1000 萬美元和 230 萬美元。最後，我們認識到與 Progenics 的對外授權資產相關的里程碑。

Gross profit margin for the third quarter was 68.2%, an increase of 109 basis points. Favorable product mix on year-over-year strength of PYLARIFY and DEFINITY was offset in part by higher contracted material freight and overhead costs.

第三季毛利率為68.2%，較去年同期成長109個基點。PYLARIFY 和 DEFINITY 的強勁產品組合在一定程度上被更高的合約材料運費和間接費用所抵消。

Operating expenses at 24.6% of net revenue were 111 basis points higher than the prior year rate, with a focus on increased R&D investment in support of our early and late-stage assets. Sales and marketing efforts concentrated on PYLARIFY brand strategy, market research, and patient advocacy. ERP cost of ownership and optimization projects were the primary investment drivers for G&A.

營業費用佔淨收入的 24.6%，比去年同期高出 111 個基點，重點增加研發投入以支持我們的早期和後期資產。銷售和行銷工作集中在 PYLARIFY 品牌策略、市場研究和患者宣傳。ERP 擁有成本和優化項目是 G&A 的主要投資驅動因素。

Operating profit for the quarter was $165.1 million, an increase of 18.3%.

本季營業利潤為1.651億美元，成長18.3%。

Net other income of $5.1 million is a result of nearly $10 million of interest income, offset in part by interest expense on our existing debt.

510 萬美元的淨其他收入來自近 1000 萬美元的利息收入，部分抵消了我們現有債務的利息支出。

Total adjustments in the quarter was $6 million of gain before taxes. Of this amount, $20.4 million and $11.9 million of expense is associated with non-cash stock and incentive plans and acquired intangible amortization, respectively. $37.3 million of net unrealized gain is tied to our equity investments in prospective and Radiopharm Theranostics, with the remainder relating to acquisition, integration, and other non-recurring expenses.

本季的總調整為稅前收益 600 萬美元。其中，2,040 萬美元和 1,190 萬美元的費用分別與非現金股票和激勵計畫以及收購無形資產攤提有關。 3,730 萬美元的淨未實現收益與我們對潛在和 Radiopharm Theranostics 的股權投資有關，其餘部分與收購、整合和其他非經常性費用有關。

Our effective tax rate was 27.1%. The resulting GAAP reported net income for the third quarter was $131 million and $124.1 million on an adjusted basis, an increase of 20.4%.

我們的有效稅率為27.1%。由此得出的第三季 GAAP 淨收入為 1.31 億美元，調整後為 1.241 億美元，成長 20.4%。

Weighted average, fully diluted share count outstanding was 73.1 million shares, slightly lower than previously guided. GAAP fully diluted earnings per share for the third quarter were $1.79 and $1.70 on an adjusted basis, an increase of 15.6%.

加權平均、完全稀釋的流通股數為 7,310 萬股，略低於先前的預期。第三季 GAAP 完全攤薄每股收益為 1.79 美元，調整後為 1.70 美元，成長 15.6%。

Now turning to cash flow, third-quarter operating cash flow totaled $175.1 million, $58.3 million over prior year. Capital expenditures totaled $15.8 million, essentially flat with the prior year. Free cash flow, which we define as operating cash flow less capital expenditures, was $159.3 million, an increase of $57.1 million over the prior year.

現在談到現金流，第三季營運現金流總計 1.751 億美元，比去年同期增加 5,830 萬美元。資本支出總計1,580萬美元，與上年基本持平。自由現金流（我們將其定義為經營現金流減去資本支出）為 1.593 億美元，比前一年增加 5,710 萬美元。

During the quarter, the company invested $47 million to acquire RM2 from Life Molecular, as well as to in-license preclinical assets TROP2 and LRRC15 from Radiopharm Theranostics, and we made the tech transfer milestone payment related to the NAV-4694 asset. Concurrently, we invested $5 million in common shares at Radiopharm.

本季度，該公司投資 4,700 萬美元從 Life Molecular 收購 RM2，以及從 Radiopharm Theranostics 獲得臨床前資產 TROP2 和 LRRC15 的許可，並且我們支付了與 NAV-4694 資產相關的技術轉移里程碑付款。同時，我們向Radiopharm投資了500萬美元的普通股。

Taken together, cash and cash equivalents, net of restricted cash, now stands at $866.4 million. We also have access to our $350 million undrawn bank revolver, adding to our strong liquidity position.

整體來看，扣除受限現金後，現金和現金等價物現為 8.664 億美元。我們還可以使用 3.5 億美元未提取的銀行循環信貸，這增強了我們的流動性狀況。

We'd like to note that the company's 2027 $575 million convertible debt was reclassified to a current liability as of September 30, as the company's stock price remained above the 130% of the conversion price threshold for more than 20 of the last 30 business days in the quarter, in accordance with the bond's terms and conditions. The reclass will distort the period of working capital statistics. As I have noted, the company has more than sufficient liquidity and access to capital to manage the reclassification implication.

我們想指出的是，截至9 月30 日，該公司2027 年5.75 億美元的可轉換債務已重新歸類為流動負債，因為該公司的股價在過去30 個工作日中有超過20 個工作日保持在轉換價格門檻的130% 以上依照該債券的條款和條件，本季。重新分類將會扭曲營運資本統計的期間。正如我所指出的，該公司擁有足夠的流動性和資本來管理重新分類的影響。

Turning now to revenue and adjusted EPS guidance for the full year, we are narrowing our view of revenue to be in a range of $1.51 billion to $1.52 billion from the prior range of $1.5 billion to $1.52 billion. We continue to expect PYLARIFY to grow mid-20% over 2023, as has been the case over the last couple of quarters.

現在談到全年營收和調整後每股盈餘指引，我們將營收預期從先前的 15 億美元至 15.2 億美元縮小至 15.1 億美元至 15.2 億美元之間。我們繼續預計 PYLARIFY 在 2023 年將成長 20% 左右，就像過去幾個季度的情況一樣。

We are also narrowing our view of fully diluted adjusted earnings per share, which should now be in a range of $6.65 to $6.70, from the prior range of $6.60 to $6.70. This guide reflects timing differences between Q3 and Q4 within our operating expense lines. It also considers near-term financial impacts from organizational changes we took late last month to retool the company for future growth.

我們也縮小了對全面攤薄調整後每股收益的預期，目前範圍應在 6.65 美元至 6.70 美元之間，而非之前的 6.60 美元至 6.70 美元之間。本指南反映了我們營業費用線中第三季和第四季之間的時間差異。它也考慮了我們上個月底為重組公司以適應未來成長而進行的組織變革所帶來的近期財務影響。

This action will create an approximately $0.02 benefit in Q4 that we would expect to reverse in 2025 as we hire new talent with the skills and capabilities that align with our strategic direction. As has been the case all year, this estimate does not include any incremental investment for PNT2002 nor any further business development that might be completed this year.

此舉將在第四季度帶來約 0.02 美元的收益，我們預計這一收益將在 2025 年逆轉，因為我們將聘用具有符合我們戰略方向的技能和能力的新人才。與全年的情況一樣，該估算不包括 PNT2002 的任何增量投資，也不包括今年可能完成的任何進一步業務開發。

With that, let me turn the call back over to Brian.

說完這些，讓我把電話轉回給布萊恩。

Thank you, Bob.

謝謝你，鮑伯。

As the leading radiopharmaceutical-focused company, Lantheus has accomplished a lot and has an amazing future. We have levered the strength of our SPECT and DEFINITY franchises and successfully launched PYLARIFY to become the first PET radiopharmaceutical diagnostic blockbuster.

作為一家領先的專注於放射性藥物的公司，Lantheus 已經取得了許多成就，並且前景光明。我們利用 SPECT 和 DEFINITY 特許經營的優勢，成功推出了 PYLARIFY，成為第一個 PET 放射性藥物診斷重磅產品。

With the success of our commercial products as a foundational engine, we have invested in our emerging R&D pipeline, expanding it to include new innovative product candidates, including radiotherapeutics and Alzheimer's radiodiagnostics. We will continue to pursue thoughtful business development and M&A and intelligently deploy our capital.

憑藉我們商業產品作為基礎引擎的成功，我們投資了新興的研發管道，將其擴展到包括新的創新產品候選，包括放射治療和阿茲海默症放射診斷。我們將繼續進行深思熟慮的業務發展和併購，並明智地配置我們的資本。

I'm proud to report that since the beginning of 2024, Lantheus commercial products have made a positive difference in the lives of over 5.2 million patients and their families. Lantheus remains at the forefront of radiopharmaceutical innovation and is positioned to deliver sustainable long-term growth and continued success in our endeavor to find, fight, and follow disease to deliver better patient outcomes. We look forward to delivering on these commitments.

我很自豪地報告，自 2024 年初以來，Lantheus 商業產品已為超過 520 萬名患者及其家人的生活帶來了積極的變化。Lantheus 始終處於放射性藥物創新的前沿，致力於實現可持續的長期成長和持續的成功，努力發現、對抗和追蹤疾病，為患者提供更好的治療效果。我們期待履行這些承諾。

Operator, we're now ready to take questions. You can proceed.

接線員，我們現在可以回答問題了。您可以繼續。

(Operator Instructions) Roanna Ruiz, Leerink Partners.

(操作員指示) Roanna Ruiz，Leerink Partners。

Hi. Good morning, everyone. So a quick one for me, could you talk a bit more about the factors behind PYLARIFY's 3Q revenues? I appreciate that there was a bit of a seasonality impact, and I was also curious if there were some changes or new strategic partnerships that might have come online. And could you help us think about how this should flow into the rest of the year?

你好。大家早安。所以我只想問一個簡單的問題，您能否詳細談談 PYLARIFY 第三季營收背後的因素？我知道這有一定的季節性影響，但我也很好奇是否會有一些變化或新的策略夥伴關係出現。您能否幫助我們思考如何將這項工作貫穿今年剩餘的時間？

Thanks, Roanna. So as we mentioned on the call, PYLARIFY grew 20% year over year in the third quarter and it does remain on track to grow mid-20% in 2024 and reach blockbuster status, in line with our prior guidance, and really being the first-ever PET imaging agent to reach blockbuster status.

謝謝，羅安娜。因此，正如我們在電話會議上提到的那樣，PYLARIFY 在第三季度同比增長了20%，並且預計在2024 年實現20% 左右的增長率，並達到轟動地位，這與我們之前的預期一致，而且它確實是第一個- 有史以來最暢銷的 PET 成像劑。

We did expect Q3 and Q4 PYLARIFY revenue splits to favor Q4 on an absolute dollar basis. That's driven by the third-quarter seasonality, not only from physician vacation schedules, but also two significant holidays of July 4th and Labor Day during the quarter.

我們確實預期 PYLARIFY 第三季和第四季的營收分成將以絕對美元計算有利於第四季。這是由第三季的季節性因素推動的，不僅包括醫生的休假安排，還包括本季的兩個重要節日 7 月 4 日和勞動節。

In the quarter for PYLARIFY sequentially, the overwhelming majority of our accounts did grow on an absolute basis in line with the broader market. The sequential decline was really driven by, one, traditional third-quarter seasonality with third quarter usually being the lightest sequential growth driver of the year; also, the net price impact of our recently secured strategic partnerships. This has been an effort that we've been underway since the beginning of the year. It continues to ramp throughout the year, and we certainly saw an impact to net price and really net price compression from third quarter versus second quarter, which drove the majority of the sequential decline.

在 PYLARIFY 連續季度中，我們的絕大多數帳戶確實與大盤同步絕對成長。造成連續下滑的主要原因是：一是傳統的第三季季節性因素，第三季通常是一年中連續成長動力最弱的季度；還有我們最近達成的策略夥伴關係的淨價格影響。這是我們自今年年初以來一直在進行的一項努力。它全年都在持續上升，我們確實看到淨價格受到了影響，並且與第二季度相比，第三季度的淨價格確實受到了壓縮，這導致了大部分的連續下降。

And then lastly, we did make some intentional tradeoffs, largely due to product availability, and there were a handful accounts we chose not to match a lower price from the competition, where price at these transactional customers was more important than quality. And so we expect going forward, which I think is the focus, that we are going to remain the PSMA PET imaging agent of choice, the number one in the market, that we are incredibly well positioned to grow revenue sequentially in the fourth quarter and to sustain $1 billion franchise for PYLARIFY going forward.

最後，我們確實做出了一些有意的權衡，這主要是由於產品的可用性，並且有少數帳戶我們選擇不匹配競爭對手的較低價格，因為對於這些交易客戶來說，價格比品質更重要。因此，我們預計，我認為重點是，我們將繼續成為 PSMA PET 成像劑的首選，成為市場上的頭號人物，我們處於非常有利的位置，可以在第四季度連續增加收入，為PYLARIFY 未來維持10 億美元的特許經營權。

Anthony Petrone, Mizuho Group.

瑞穗集團的安東尼‧佩特羅內 (Anthony Petrone)。

Thanks, and congratulations on another good quarter here and the positive announcement from CMS. Maybe, Paul, just to clear up some of the comments on the final rates for 2025. You said they're largely in line. I know there was some confusion out there between mean unit cost and ASP, but Addendum B seems pretty clear that the reimbursement rate for PYLARIFY will remain steady in 2025. So just to parse out that in a little bit more detail.

謝謝，恭喜我們又一個好的季度以及 CMS 的積極公告。保羅，也許只是為了澄清一些關於 2025 年最終利率的評論。您說他們基本上都一致。我知道平均單位成本和 ASP 之間存在一些混淆，但附錄 B 似乎很清楚地表明，PYLARIFY 的報銷率在 2025 年將保持穩定。因此，我們來更詳細地分析一下這一點。

And then maybe just quickly, I'll sneak it in, just the implied 4Q guide is a little bit light. So just maybe talk through the bridge between the first nine months and the 2024 guide by the step-down sequentially. Thanks again. Congratulations.

然後也許只是很快，我會偷偷地把它放進去，只是隱含的 4Q 指南有點輕。因此，也許可以按順序討論前九個月和 2024 年指南之間的橋樑。再次感謝。恭喜。

Thanks, Anthony. So maybe I'll take the CMS question, and then I'll let Bob answer the 4Q piece.

謝謝，安東尼。所以也許我會回答 CMS 問題，然後讓鮑伯回答 4Q 部分。

So as we mentioned in the prepared remarks, and I think as you noted, we're incredibly pleased with the actions that CMS announced on Friday evening, recognizing the value that innovative radiopharmaceutical diagnostics can have on patient care and the importance of ensuring consistent access. CMS did note that they would be paying separately for radiopharm diagnostics above a 630-day arithmetic mean cost, which really just allows for some lower-priced products to remain bundled and then the more innovative products to be separately paid, recognizing that PET radiopharmaceutical diagnostics, as well as some SPECT, are not interchangeable and they need to be paid separately.

因此，正如我們在準備好的演講中提到的那樣，我想正如您所指出的那樣，我們對CMS 週五晚上宣布的行動感到非常高興，並認識到創新放射性藥物診斷對患者護理的價值以及確保持續獲取的重要性。CMS 確實指出，他們將單獨支付超過630 天算術平均成本的放射性藥物診斷費用，這實際上只是允許一些價格較低的產品保持捆綁，然後對更具創新性的產品進行單獨支付，並認識到PET放射性藥物診斷以及一些 SPECT 不可互換，需要單獨付費。

Now, what we saw coming out of CMS on Friday is that the final 2025 calendar year payment rate for PYLARIFY very much matches and is effectively the same as its existing payment rate for Medicare fee-for-service patients in the hospital outpatient setting. And so what that really does is sustain PYLARIFY payment in that for 2025.

現在，我們看到 CMS 週五公佈的消息是，PYLARIFY 的 2025 日曆年的最終支付率與醫院門診中 Medicare 按服務收費患者的現有支付率非常匹配，實際上相同。所以這實際上就是維持 2025 年的 PYLARIFY 付款。

Clearly, there has been some confusion and discussion on the marketplace on the differences between payment rates and what CMS was going to use. I think CMS specifically highlighted seven agents that we note -- six PET, one SPECT -- that had a material improvement in the payment rate in the final rules versus that of the draft rules in July. And the commonality for the vast majority of those are those are agents that have recently lost pass-through or are expected to lose pass-through within the next 12 to 15 months.

顯然，市場上對於支付率與 CMS 將要使用的支付率之間的差異存在一些困惑和討論。我認為 CMS 特別強調了我們注意到的七位代理商——六位 PET、一位 SPECT——與 7 月的草案規則相比，最終規則中的支付率有實質性的提高。其中絕大多數的共同點是這些代理商最近失去了轉運權或預計將在未來 12 到 15 個月內失去轉運權。

And so those agents are already reporting their true cost to CMS. And therefore, we believe that CMS put in place the payments that they did to support sustained access for those innovative radiopharmaceuticals, and we think this sets us up well for continued growth in the overall market and for PYLARIFY to continue to lead.

因此這些代理商已經向 CMS 報告了他們的真實成本。因此，我們相信 CMS 已經實施了支付措施來支持這些創新放射性藥物的持續使用，我們認為這為整個市場的持續成長和 PYLARIFY 繼續保持領先地位奠定了基礎。

I'll turn it over to Bob on some of the 4Q guide questions.

我會把一些 4Q 指導性問題交給鮑伯。

All right. Thanks. Good morning, Anthony.

好的。謝謝。早安，安東尼。

So from a revenue perspective, you've got to take it by the different pieces. So if you stop and think about PYLARIFY, first and foremost, as Paul has noted multiple times in his prepared remarks, on track for mid-20% for the full year and we do expect, from a net and gross basis, PYLARIFY would be, both sequentially and year over year, improved moving from Q3 into Q4. From a pure dollar perspective, we had always thought that Q4 would be greater than Q1.

因此，從收入角度來看，你必須根據不同的部分來考慮。因此，如果你停下來思考一下PYLARIFY，首先，正如保羅在他的準備好的發言中多次指出的那樣，PYLARIFY 全年的增長率有望達到20% 左右，我們確實預計，從淨值和毛值來看，PYLARIFY 將是無論是環比還是同比，從第三季到第四季都有所改善。從純美元角度來看，我們一直認為第四季的表現將優於第一季。

DEFINITY looks to be sort of 10%-ish for the year, and -- but that and the SPECT business, as Paul noted that there are some competitive dynamics with people having -- other competitors having supply issues, we don't forecast those kinds of things to necessarily continue because we don't control that part of the business. So from that perspective, I do think that there could be some opportunity for overperformance in both of those, but at the same time, again, we don't forecast for those type elements.

DEFINITY 今年的成長率看起來在 10% 左右，但正如 Paul 所說，SPECT 業務存在一些競爭動態，其他競爭對手存在供應問題，我們無法預測這些這種事情必然會繼續下去，因為我們無法控制這部分業務。因此從這個角度來看，我確實認為這兩者都可能存在一些表現優異的機會，但同時，我們再次沒有對這些類型元素進行預測。

As far as EPS goes, yes, absolutely, it is a step-down from Q3 into Q4. But that's predicated on the fact that, as I had noted, even on the prior call, we would expect R&D expenses to increase from Q3 to Q4. And that is really the biggest step-up in OpEx between the two quarters, and hence the step-down in projected earnings.

就每股收益而言，是的，絕對如此，從第三季度到第四季度，每股收益有所下滑。但這是基於這樣一個事實，正如我所指出的，即使在先前的電話會議上，我們預計研發費用將從第三季增加到第四季。這實際上是兩個季度之間營運支出的最大增幅，因此預計收益有所下降。

Richard Newitter, Truist Securities.

Truist Securities 的 Richard Newitter。

Hi. Thanks for taking the questions -- or a question. Just sticking on PYLARIFY, kind of a two-part single question, sorry. You said you maintain confidence that you can see PYLARIFY sustaining as a $1 billion franchise in 2025. You used the word sustain, not grow, and you provided commentary just now that it sounds like your assumption is that the pricing in the hospital patient Medicare setting is not going to be all that different than what it's been.

你好。感謝您回答這些問題—或提出一個問題。只是堅持 PYLARIFY，這是一個由兩部分組成的單一問題，抱歉。您曾說過，您有信心到 2025 年 PYLARIFY 能夠成為價值 10 億美元的特許經營企業。您使用了「維持」而不是「成長」這個詞，而且您剛才發表評論說，聽起來您的假設是，醫院病患醫療保險環境中的定價與以前不會有太大差別。

Just help me reconcile why you use the words sustain instead of grow. And then do you have direct dialogue with CMS that gives you that level of confidence to know that this is going to be unchanged pricing at a market level in 2025? Just what's your degree of confidence there, or is that something that you're assuming, but it could change? Thank you.

請幫助我理解為什麼您使用“維持”這個詞而不是“成長”這個詞。那麼，您是否與 CMS 進行直接對話，讓您有信心知道 2025 年的市場水平定價將保持不變？您對此的信心程度到底如何，或者這只是您的假設，但它可能會改變？謝謝。

Yes. Thanks for mixing up the questions like that. I'm not sure what we want to answer first, but why don't we start with PYLARIFY? And I think Paul was pretty clear. We do anticipate PYLARIFY growth next year. We're referring to volume growth specifically.

是的。謝謝你提出這樣的混合問題。我不確定我們首先要回答什麼，但是為什麼我們不從 PYLARIFY 開始呢？我認為保羅說得非常清楚。我們確實預計 PYLARIFY 明年會成長。我們特別指的是銷量成長。

Paul, do you want to just add on to that?

保羅，你想補充一下嗎？

Rich, I think we're confident we're going to sustain, as I said, a $1 billion franchise. We're still just wrapping up the third quarter.

里奇，我想我們有信心，正如我所說的，我們將維持 10 億美元的特許經營權。我們剛結束第三季。

Based on the roll-in of our strategic partnerships, we have seen net price compression in the third quarter based on securing those long-term partnerships. We would expect those to normalize over the course of 2025 and effectively be reflected in the comparables, and so they will still have an impact as they roll in on an annualized basis. But from a volume perspective, we expect the market to continue to grow. The addressable market, currently $2 billion, as we look to additionally approve radiotherapeutics, as we look to increasing incidence and prevalence, and the continued adoption of PSMA PET over more conventional imaging, we think that market can continue to grow.

基於我們戰略合作夥伴關係的推進，我們在第三季度看到了基於鞏固這些長期合作關係的淨價格壓縮。我們預計這些因素將在 2025 年期間正常化，並有效反映在可比較數據中，因此，隨著它們按年率計算，仍將產生影響。但從數量來看，我們預期市場將持續成長。目前的潛在市場規模為20 億美元，隨著我們期待進一步批准放射治療方法，隨著我們期待發病率和患病率的提高，以及PSMA PET 相對於更傳統的成像的持續應用，我們認為市場可以繼續增長。

At this point, we're still just at the end of the third quarter. It remains a dynamic environment, and so that's what we're comfortable saying today. But we remain very positive on the overall market, recognizing that these strategic partnerships are secured and roll in, that there is a transitory impact on net price.

到目前為止，我們仍處於第三季末。它仍然是一個充滿活力的環境，因此我們今天可以輕鬆地這麼說。但我們對整體市場仍然非常樂觀，認識到這些策略夥伴關係的穩固和推進，對淨價的影響是暫時的。

On the CMS side of things, I think we have engaged with CMS in the past. We will continue to reach out to them. Based on what we've seen, as well as potential alternatives, we feel like PYLARIFY is in a very good position for 2025, as are a number of other innovative radiopharmaceutical diagnostics.

從 CMS 方面來說，我認為我們過去曾與 CMS 有合作。我們將繼續與他們聯繫。根據我們所看到的情況以及潛在的替代方案，我們認為 PYLARIFY 在 2025 年將處於非常有利的地位，其他一些創新的放射性藥物診斷方法也是如此。

Naturally, CMS always reserves the right to make adjustments should they need to. But I think in our conversations with relevant stakeholders in the marketplace, we believe that they clearly understand that innovative radiopharmaceutical diagnostics should need to be paid separately. And if we look in the broadest brushes, we're talking about potentially 20% of patients that has declined over time as Medicare Advantage continues to gain share over Medicare fee-for-service. And so even if we were to see some minor changes, we still think we are in a very good position.

當然，CMS 始終保留在必要時進行調整的權利。但我認為，在我們與市場相關利害關係人的對話中，我們相信他們清楚地了解到創新放射性藥物診斷應該需要單獨付費。而如果我們從最廣泛的角度來看，隨著醫療保險優勢計劃在醫療保險按服務收費方面的份額不斷增加，我們談論的是可能 20% 的患者人數會隨著時間的推移而減少。因此，即使我們看到一些細微的變化，我們仍然認為我們處於非常有利的地位。

I think I would also note that CMS made it very clear that they're open to paying on ASP going forward. That was in both their proposed rule, as well as in the final rule. Unfortunately, there are a number of agents that don't or have not reported ASP because it is not required.

我想我還要指出的是，CMS 明確表示他們願意以 ASP 付款。這既包含在他們提議的規則中，也包含在最終規則中。不幸的是，有很多代理商沒有報告 ASP，或沒有報告 ASP，因為這不是必要的。

PYLARIFY, as well as many other agents, have under pass-through. We will continue to report ASP, and so we feel there's a very clear path forward for PYLARIFY to retain separate payment and to be paid for those Medicare fee-for-service patients in the hospital outpatient setting at a rate that does not disadvantage PYLARIFY relative to other PSMA PET agents.

PYLARIFY 和許多其他藥劑一樣，都具有傳遞功能。我們將繼續報告平均售價，因此我們認為PYLARIFY 有一條非常明確的前進道路，即保留單獨付款，並以不會使PYLARIFY 處於相對不利的費率向醫院門診環境中的醫療保險按服務收費患者支付費用對其他 PSMA PET 藥劑。

Matt Taylor, Jefferies.

傑富瑞的馬特泰勒 (Matt Taylor)。

Hi. Thanks for taking the question. Just as a follow-up, I wanted to see if we could pin down on the final addendum there. The unit price is $650. Is that the price that you understand you're going to get now?

你好。感謝您回答這個問題。作為後續行動，我想看看我們是否可以確定最後的附錄。單價為650美元。這就是您現在能得到的價格嗎？

And as far as the strategic contracting goes, obviously you gave up some price to lock up these partners longer term. Can you talk about your ability to adjust pricing within those contracts if you are going to get this better price in the future?

就策略承包而言，顯然你會放棄一些價格來長期鎖定這些合作夥伴。如果您將來想要獲得更優惠的價格，您能談談您在這些合約中調整價格的能力嗎？

Yeah, I'll take the last question. And to be fair, we really don't lock up anything. We're engaged in a partnership with our key customers to help them grow the business while we grow alongside them. And we're not going to comment on the details in those partnerships because that's obviously competitive intelligence that we just don't want to share.

是的，我來回答最後一個問題。公平地說，我們確實沒有鎖定任何東西。我們與主要客戶建立合作關係，幫助他們發展業務，同時我們也與他們一起成長。我們不會對這些合作關係的細節發表評論，因為這顯然是我們不想分享的競爭情報。

With regard to the pricing, Paul?

關於定價，保羅？

Matt, you're reading Addendum B correctly on the proposed price. Naturally, we look at the average millicuries used per dose to come out to a proposed or final, in this case, final payment rate for 2025. It's not to say that CMS does not reserve the right to make adjustments, but we feel confident that PYLARIFY is going to be paid appropriately in 2025 and that if an issue at all, it's a far smaller issue than we were, say, at the beginning of the year before CMS came out with these rules to recognize the value that innovative radiopharmaceuticals come out with.

馬特，你正確地解讀了附錄 B 中關於建議價格的內容。當然，我們會考慮每個劑量所使用的平均毫居里數，以得出建議的或最終的支付率，在本例中是 2025 年的最終支付率。這並不是說 CMS 不保留做出調整的權利，但我們相信 PYLARIFY 將在 2025 年得到適當的支付，而且如果有問題的話，那也是一個比我們在今年年初，CMS 出台了這些規則，以承認創新放射性藥物的價值。

And as noted, there are a number of agents where the payment rate materially increased from the proposed rules to the final rules. And the common thread appears to be recently having lost TPT or about to be losing TPT, which is consistent with reporting ASP.

如上所述，與擬議規則相比，許多代理商的支付率都有所提高。並且，共同點似乎是最近已經失去 TPT 或即將失去 TPT，這與報告 ASP 一致。

Larry Solow, CJS Securities.

索洛（Larry Solow），CJS 證券公司。

Great. Good morning. Just on this pricing issue, can you just maybe give us a little more color on how much of the price or the strategic partnerships were implemented this quarter? Just like a rough idea, was there a significant material amount of them, or was there a lot more that still have not rolled in yet? Or is this kind of a good basis to annualize what that impact was based on what happened this quarter?

偉大的。早安.僅就這個定價問題而言，您能否向我們詳細介紹本季實施的價格或策略夥伴關係？就像一個粗略的想法，它們的數量是否相當可觀，或者是否還有更多尚未滾滾而來？或者說，這是否是根據本季發生的情況，將影響年度化的一個好基礎？

And the second question is just on -- it sounds like you're a little bit hesitant to give guidance for next year, and I fully understand that. But do you still expect PYLARIFY to grow on a multi-year basis, both volume and less impact from price to continue to grow it on a revenue basis? Thanks.

第二個問題是──聽起來您對明年的指引有點猶豫，我完全理解這一點。但是，您是否仍預期 PYLARIFY 將在多年基礎上實現成長，既能維持銷售成長，又能減少價格影響，進而繼續實現營收成長？謝謝。

So appreciate the question there. I think we're incredibly positive, if I look at the long term first, about the growth in the PSMA PET imaging market. We've highlighted an addressable market that's currently around $2 billion and could grow to $3 billion by the end of the decade. And those are based, as I mentioned earlier, on incidence prevalence, the continued adoption of radiotherapeutics, as well as continued adoption of PSMA PET versus conventional imaging.

非常感謝您的提問。我認為，如果首先從長遠來看，我們對 PSMA PET 成像市場的成長持非常樂觀的態度。我們重點關注的潛在市場目前約為 20 億美元，到本世紀末可能會成長到 30 億美元。正如我之前提到的，這些都是基於發病率、放射治療方法的持續採用以及 PSMA PET 與傳統影像的持續採用。

On the specific pricing piece, I think we're very pleased with the progress that we've made. As the market leader, these are very positive conversations with key customers. We kicked this off, as we've highlighted in the past, last year. It really gained steam throughout the course of this year.

在具體的定價部分，我認為我們對所取得的進展感到非常滿意。作為市場領導者，這些都是與關鍵客戶進行的非常積極的對話。正如我們過去所強調的那樣，我們去年就開始了這項工作。今年以來，它確實發展得如火如荼。

We will see continued impact as we get deeper into the year, with Q4 still partnerships being signed and the full annualization of a full quarter's worth. And so I think we're really going to see this normalize throughout the first half of next year, with the second half of '25 really being a kind of go-forward net price compression solidified, given that these are full-year, multi-year contracts in nature.

隨著今年的深入，我們將看到持續的影響，第四季度仍有合作協議簽署，整個季度的價值將實現年化。因此，我認為我們將在明年上半年看到這種情況正常化，而 25 年下半年將真正成為一種向前的淨價格壓縮，考慮到這是全年、多年期合約性質。

And so we're really in the phase-in period where the biggest driver of sequential performance was really the rollout of these. And so we feel very positive that this is a transitory impact that then overall the market will continue to grow, PYLARIFY will continue to lead and grow, and this is a very sustainable franchise going forward.

因此，我們實際上正處於逐步實施的時期，其中連續性能的最大驅動力實際上是這些產品的推出。因此，我們非常積極地認為這只是暫時的影響，總體而言，市場將繼續成長，PYLARIFY 將繼續引領和發展，這是一個非常永續的特許經營。

Tara Bancroft, TD Cowen.

塔拉·班克羅夫特（TD Cowen）。

Hi. Good morning, and thanks for taking the questions. So I'm going to deviate a little bit from the pricing questions, but I'm curious to hear more on the Alzheimer's diagnostic pipeline. So can you tell us how these assets differentiate from what's currently available or the blood tests that are coming down the external or the other pipeline? What's your thinking on that and on the market for these? And could we potentially hear a little bit more about these in 2025?

你好。早上好，感謝您回答問題。因此，我將稍微偏離定價問題，但我很好奇想聽到更多關於阿茲海默症診斷管道的資訊。那麼您能告訴我們這些資產與目前可用的資產或來自外部或其他管道的血液檢查有何區別嗎？您對此以及市場有何看法？我們是否有可能在 2025 年聽到更多有關這些的消息？

Yeah. And thank you for taking us off the pricing track. That's a relief, I guess, because I don't know how many times we can say the same thing.

是的。感謝您讓我們脫離定價軌道。我想，這是一種解脫，因為我不知道我們能說多少次同樣的話。

So with our Alzheimer's portfolio, we're, I think, really excited about these assets with MK-6240 and NAV because they appear to be best-in-class assets where they have really great detection rates, de minimis off target, and I think they're in a very advanced Phase III development right now. So Jeff, do you want to comment a little bit more?

因此，我認為，對於我們的阿茲海默症產品組合，我們對MK-6240 和NAV 等資產感到非常興奮，因為它們似乎是同類中最好的資產，具有非常好的檢測率，偏離目標的機率極小，而且我認為他們現在正處於非常先進的第三階段開發中。那麼傑夫，你想再發表一點評論嗎？

Yeah, thank you. I mean, these are exciting compounds. They're second generation. They have a high degree of sensitivity and low off-target binding, as mentioned in the comments.

是的，謝謝。我的意思是，這些都是令人興奮的化合物。他們是第二代。正如評論中所提到的，它們具有高度的靈敏度和低的脫靶結合率。

I think you were asking the question about serologic markers for tau versus MK-6240 imaging. The big difference being that you can see the anatomy with the PET imaging, and that correlates with issues such as symptom severity, the rate of decline, and that's important information.

我認為您問的是有關 tau 血清學標記與 MK-6240 成像的問題。最大的區別在於，你可以透過 PET 影像看到解剖結構，而這與症狀嚴重程度、衰退速度等問題相關，這是重要的訊息。

And as mentioned in the comments, the Alzheimer's Association has recommended imaging of tau and beta amyloid for the diagnosis staging and, in some cases, monitoring of treatment for Alzheimer's disease. So we're pretty excited about this portfolio.

正如評論中所提到的，阿茲海默症協會建議對 tau 和 β 澱粉樣蛋白進行成像，以進行診斷分期，並在某些情況下監測阿茲海默症的治療。所以我們對這個投資組合感到非常興奮。

Thanks, Jeff. Maybe just a few more points to add, Tara, because I think it's an area that we're incredibly excited about in the portfolio.

謝謝，傑夫。塔拉，也許我還需要補充幾點，因為我認為這是我們投資組合中非常興奮的領域。

Naturally, not only for the potential, if you look at what analysts are forecasting for the uptake of disease-modifying therapies, they're looking at potentially north of 500,000 individuals on therapy by the end of the decade, and that's just based on recently approved agents. If you look at their labels and note that they are requiring the presence, in this case, of beta amyloid pathology, that creates a very large potential market for Alzheimer's PET imaging. We've looked at it to be about $1.5 billion by the end of the decade and $2.5 billion by the middle of the 2030s, and so that's a significant opportunity.

當然，不僅僅是潛力，如果你看看分析師對疾病改良療法的接受程度的預測，他們預計到本世紀末，可能會有 50 多萬人接受治療，這只是基於最近的批准代理商。如果你看一下它們的標籤並注意到它們需要存在β澱粉樣蛋白病理，那麼這為阿茲海默症 PET 成像創造了一個非常大的潛在市場。我們預計到本世紀末這個數字將達到約 15 億美元，到本世紀 30 年代中期將達到 25 億美元，因此這是一個重大機會。

Serological blood testing very much is going to have a role in this marketplace. I think we look at it as very complementary to imaging, much as we've seen in prostate cancer, where PSA screening becomes commonplace when a man reaches the age of 45 or 50. But that really helps determine, along with many other factors, which patients are appropriate for a PSMA PET scan, and we believe, eventually, will be appropriate for an Alzheimer's PET scan, which can only grow the market from a complementary basis.

血清學血液檢測在這個市場中將發揮重要作用。我認為我們將其視為對影像的補充，就像我們在前列腺癌中看到的那樣，當男性達到 45 或 50 歲時，PSA 篩檢變得很常見。但這確實有助於確定哪些患者適合進行 PSMA PET 掃描，以及許多其他因素，我們相信，最終將適合進行阿茲海默症 PET 掃描，這只能從互補的基礎上擴大市場。

And I would note, it's somewhat obvious, but these are both F18 agents that would lever the same commercial and production infrastructure that we've established with PYLARIFY. And so we really like the position and the opportunity to continue to grow with the overall therapeutic market for the support of both diagnosis, staging, and monitors, which create significant scan potential per individual patient.

我想指出的是，這有點明顯，但這些都是 F18 代理，它們將利用我們與 PYLARIFY 建立的相同商業和生產基礎設施。因此，我們非常喜歡這個地位和機會，能夠與整個治療市場一起繼續成長，為診斷、分期和監測提供支持，從而為每個患者創造巨大的掃描潛力。

Yuan Zhi, B. Riley.

袁志，B.Riley。

Good morning. Thank you for taking our questions. Maybe asking the question differently, so for the CMS reimbursement rate update, we saw that the MUC method will get a lower reimbursement rate for PYLARIFY. However, in this latest update, it actually went up. So how should we think about this calculation? And what does it mean to 2026 if there is a change from this MUC method to ASP method? Thank you.

早安.感謝您回答我們的問題。也許問的問題不同，因此對於 CMS 報銷率更新，我們看到 MUC 方法將獲得較低的 PYLARIFY 報銷率。然而，在這次最新更新中，它實際上上漲了。那我們該如何思考這個計算呢？如果從這種 MUC 方法轉變為 ASP 方法，那麼對 2026 年來說又意味著什麼？謝謝。

Yuan, I appreciate and know there's a lot of considerations in the marketplace, so understand there's some confusion in the differences with what CMS has come out with. I think what we've seen, and I don't mean to just reiterate, but what I think we've seen is CMS came out with their calendar year 2025 rules, which is different, just to note, for some other CMS payment mechanisms whereby they adjust quarterly. This is a calendar year final rate. Naturally, they reserve the right to make adjustments, but there is commonality among some of the material adjustments they've made.

袁，我理解並知道市場上有許多考慮因素，因此可以理解人們對 CMS 所推出的產品的差異存在一些困惑。我認為我們已經看到了，我並不是想重申，但我認為我們已經看到了 CMS 發布了他們的 2025 年規則，這與一些其他 CMS 付款不同，需要注意的是每季進行調整的機制。這是日曆年的最終利率。當然，他們保留做出調整的權利，但他們所做的一些實質調整具有共同點。

We continue to report ASP for PYLARIFY. We have been doing so since launch. We will continue to do so going forward. And so while it's a little early to determine exactly what payment rates would be for 2026, based on the rate we have, as well as CMS's openness to paying on ASP once that becomes more ubiquitous in the radiopharmaceutical diagnostics space, we believe that that could be sustainable. We will continue to report ASP.

我們繼續報告 PYLARIFY 的 ASP。自推出以來，我們一直這樣做。我們今後將繼續這樣做。因此，雖然現在確定 2026 年的具體支付率還為時過早，但基於我們現有的費率，以及 CMS 在放射性藥物診斷領域變得更加普及後對 AS​​P 支付的開放態度，我們相信這可能會具有可持續性。我們將繼續報告 ASP。

If CMS adjusts, as they've said they would be open to, their payment mechanisms to be more based on ASP versus MUC, PYLARIFY would be set up to, again, have their payment rates reflect the true current cost to hospitals. Naturally, we will be working as part of the broader coalition to ensure that all innovative radiopharmaceutical diagnostics continue to report ASP to further support CMS's intent to move there. That's just not possible at this time, given not everyone reports ASP.

如果 CMS 進行調整（正如他們所說的那樣），他們的支付機制將更多地基於 ASP 而不是 MUC，那麼 PYLARIFY 的設置將再次使其支付率反映醫院當前的真實成本。當然，我們將作為更廣泛聯盟的一部分開展工作，確保所有創新放射性藥物診斷繼續報告 ASP，以進一步支持 CMS 遷移到該處的意圖。由於並非所有人都報告 ASP，因此目前這是不可能的。

Kemp Dolliver, Brookline Capital Markets.

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

Great. Thank you. I'm going to ask about PNT2002, and this is going to be a hypothetical question. But if CMS wants you to go to wait for 100% of events in the trial, are we looking at roughly a six-month timeframe, nine-month timeframe? What should we expect if you have to go that route?

偉大的。謝謝。我要問有關 PNT2002 的問題，這是一個假設性問題。但如果 CMS 希望您等待試驗中的 100% 事件，我們是否需要考慮大約六個月或九個月的時間範圍？如果必須走那條路，我們該期待什麼？

Yeah. I think you're referring to the FDA, and it's possible that the agency would like to see the completion of the study. If you look at the rate of reported OS events from us and our partner, it's not unreasonable to think that this will continue into the first quarter. However, clearly, we don't control the final OS event, which could keep the trial open for a bit longer. So I really prefer not to speculate too much on that. And I think we're going to confer with our partner, Lilly, as I mentioned, and also reach out to the agency to get a better understanding of a clear path forward.

是的。我想您指的是 FDA，該機構可能希望看到這項研究的完成。如果您查看我們和我們的合作夥伴所報告的作業系統事件的發生率，那麼認為這種情況將持續到第一季並不是不合理的。然而，顯然我們無法控制最終的作業系統事件，這可能會使試驗持續更長時間。所以我真的不想對此進行過多的猜測。而且我認為我們將與我們的合作夥伴禮來（正如我所提到的）進行協商，並與該機構取得聯繫，以更好地了解明確的前進道路。

Justin Walsh, JonesTrading.

賈斯汀·沃爾什（Justin Walsh），瓊斯貿易（JonesTrading）。

Hi. Thanks for taking the question. Sticking with PNT2002, I'm wondering if you can provide any commentary on the planned subset analysis analyses. And related to this, what outcomes do you think would push Lantheus to stick with the POINT-Lilly agreement versus stepping away?

你好。感謝您回答這個問題。堅持使用 PNT2002，我想知道您是否可以對計劃的子集分析提供任何評論。與此相關，您認為什麼樣的結果會促使 Lantheus 堅持 POINT-Lilly 協議而不是退出？

Yeah. We have a lot to unpack here, and I think we did mention that we are looking at subset analyses. I think if you look back at the recent ESMO meeting and Dr. Sartor's presentation, he clearly pointed out a few analyses that were post hoc, where we adjusted for the OS crossover rate and actually there's quite positive findings there that support the effect of 2002 in this population.

是的。這裡我們有很多問題需要解決，我想我們確實提到我們正在研究子集分析。我認為，如果你回顧最近的 ESMO 會議和 Sartor 博士的演講，他清楚地指出了一些事後分析，我們根據 OS 交叉率進行了調整，實際上有相當積極的發現支持 2002 年的影響在這個人群中。

I think we've got a ways to go to unpack the data, and I think with Jeff, you can comment on this a bit further if you'd like, but we continue to unpack the data. We continue to work with Lilly, and we'll meet with the agency and we'll determine the path forward from there.

我認為我們還有很長的路要走來解析數據，我認為傑夫，如果你願意的話，你可以對此進一步評論，但我們將繼續解析數據。我們將繼續與禮來公司合作，並與該機構會面，然後確定未來的發展方向。

But we've really -- I think, looking back, have already satisfied that this is a safe and effective product. I think the thing to keep in mind is that the high degree of crossover from the hormonal therapy switch arm to 2002 has completely confounded the overall survival events and the statistics behind the ITT population. So it's a bit of a conundrum. I think all of us that have designed trials like this and conducted them that have similar high crossover rates are dealing with this issue at the same time.

但我認為，回顧過去，我們已經確信這是一個安全有效的產品。我認為需要牢記的是，從 2002 年荷爾蒙治療轉換組到現在的高度交叉已經完全混淆了總體生存事件和 ITT 人群背後的統計數據。所以這有點令人困惑。我認為我們所有設計並進行過類似高交叉率試驗的人都在同時處理這個問題。

So Jeff, do you want to --

那麼 Jeff，你想--

Yeah. I would just add that it's very clear this trial met its primary endpoint. It has benefits on the quality of life endpoints, and Oliver Sartor was very positive about the study when he presented at ESMO. I think the field has been positive as well.

是的。我只想補充一點，很明顯地這次試驗達到了主要終點。它對生活品質終點有益，Oliver Sartor 在 ESMO 上發表演講時對研究表示非常積極。我認為該領域也一直保持著積極態勢。

Andy Hsieh, William Blair.

安迪謝、威廉布萊爾。

Great. Thanks for taking our question. We're curious about the $1.5 billion, $2.5 billion TAM for the Alzheimer's market. Thanks for providing that guidance. Maybe talk about kind of the number of scans dynamic that's baked into this assumption and what's currently kind of the average scans per patient and how will that grow in your view into the next decade. And along with that, how will the dialogue with payers just to ensure them that there's actually a benefit to patients as you kind of use these agents to track the disease progression on a longitudinal basis? Thank you.

偉大的。感謝您回答我們的問題。我們對阿茲海默症市場 15 億美元、25 億美元的潛在市場規模感到好奇。感謝您提供指導。也許可以談談基於此假設的掃描次數動態，以及目前每位患者的平均掃描次數是多少，以及您認為未來十年這一數字將如何增長。除此之外，當您使用這些藥物縱向追蹤病情進展時，您將如何與付款人進行對話以確保他們確實能為患者帶來益處？謝謝。

Andy, thanks for the questions. I think very spot on. We are -- when we look at the specifics around our addressable market assumptions, those are really grounded in what the broader consensus is around therapeutic uptake. And so I may have mentioned, I may not, I think we see expectations that, based on just the currently approved disease-modifying therapies for Alzheimer's, we could see 500,000 patients on therapy by the end of the decade.

安迪，謝謝你的提問。我認為非常正確。當我們研究有關可尋址市場假設的具體細節時，我們發現這些假設實際上是基於對治療吸收的更廣泛共識。因此我可能提到過，也可能沒有，我認為我們看到的預期是，僅基於目前批准的阿茲海默症的疾病改良療法，到本世紀末我們將看到 50 萬名患者接受治療。

We are still in the early stages of this market to understand exactly how many scans per patient we're going to see on a diagnosis, on a staging, and on a monitoring basis. But quick math, the list price for neurological, in this case, both tau and beta amyloid, is approximately $3,000 per scan on the market, give or take. And so with the potential of 500,000 and $3,000 per scan, you're looking at about $1.5 billion. Now, naturally, some patients will receive more scans, and indeed, not every patient that will get scanned will go on therapy. There's going to be some selection there.

我們仍處於這個市場的早期階段，需要準確了解每位患者在診斷、分期和監測方面需要進行多少次掃描。但簡單計算一下，市面上神經系統檢查（在這種情況下，tau 和 β 澱粉樣蛋白）的價格約為每次掃描 3,000 美元。因此，如果以每次掃描 50 萬張和 3,000 美元的潛在成本來計算，總價值將達到約 15 億美元。現在，自然而然地，有些患者會接受更多的掃描，事實上，並不是每個接受掃描的患者都會接受治療。那裡會有一些選擇。

I don't think we're at a point to say it's 1.x at this point in time, given we're still at the early stages of this market growth and the adoption of the therapeutics. But suffice it to say, the benefits of a scan can be tremendous. One, it meets the label for what we've seen as recently approved therapeutic agents. Two, when we look at the payer dynamic, and I think that's very astute, if you look at a scan at potentially $3,000 as a one-off event, plus a procedure cost relative to the price of these therapeutics, which appears to be in the $30,000 to $35,000 range, ensuring that with 6 million Americans who are suffering from Alzheimer's disease or advanced dementia, that the right patients get on therapy at the right time and that we monitor, as a healthcare system, their progression and ensuring they continue to respond, a PET image is a fantastic insurance policy when payers are looking at potentially tens of billions of dollars of therapeutic expense to ensure that they are getting the best patients on treatment at the right time.

考慮到我們仍處於市場成長和治療方法採用的早期階段，我認為目前我們還不能說它是 1.x。但可以說，掃描的好處是巨大的。首先，它符合我們所見的最近批准的治療藥物的標籤。第二，當我們觀察付款人動態時，我認為這是非常明智的，如果你把一次掃描可能花費 3,000 美元視為一次性事件，再加上相對於這些治療價格的程序成本，這似乎是30,000至35,000 美元的治療費用，確保600 萬患有阿茲海默症或晚期癡呆症的美國人能夠在正確的時間接受治療，並且我們作為一個醫療保健系統監控他們的病情進展，確保他們繼續回應說，當付款人面臨數百億美元的治療費用時，PET 影像是一項極好的保險政策，可確保他們能夠在正確的時間為最佳患者提供治療。

And so similar to how we've seen the adoption of PSMA PET because it can truly make an impact on what patients deserve. And while the diagnostic market is very large and we are very pleased to be playing in this, the therapeutic market is even larger and more expensive from a payer perspective. And so we think there will be a considerable value proposition for these agents to help inform care and potentially even save the healthcare system money in the long term.

這與我們看到的 PSMA PET 的採用非常相似，因為它確實可以對患者應得的治療產生影響。雖然診斷市場非常龐大，我們也很高興能夠參與其中，但從付款人的角度來看，治療市場規模更大，成本也更高。因此，我們認為這些代理人將具有相當大的價值，有助於指導護理，甚至可能在長期內節省醫療保健系統的資金。

Ed Ridley-Day, Redburn Atlantic.

艾德‧里德利-戴 (Ed Ridley-Day)，雷德伯恩大西洋公司 (Redburn Atlantic)。

Thank you very much. If we could follow up a little bit also on, if you could give any color, how we should be thinking about the royalties from PYLCLARI now that that is launched and any early color that you have on that, that would be helpful.

非常感謝。如果我們還可以進一步跟進，如果您能提供任何細節，我們應該如何考慮 PYLCLARI 的版稅，因為它已經推出，以及您對此有任何早期的詳細信息，這將會很有幫助。

And also, you highlighted, obviously, the approval of FLYCARDO. How would you be thinking about the ability to grow that business given also the supply implications?

而且，您顯然強調了對 FLYCARDO 的批准。考慮到供應方面的影響，您如何看待該業務的成長能力？

Two good questions on our partnerships. We are incredibly pleased with the approvals of PYLCLARI in Europe and in multiple markets. They've naturally-- in Europe, it is a slower ramp than in the US just given local regulatory approvals and pricing dynamics. Curium continues to commercialize that market. I think as we said in the past, overall, we're incredibly excited about the potential for PYLARIFY/PYLCLARI to be a global brand and to be discussed at medical congresses around the world.

關於我們的合作關係的兩個好問題。我們對 PYLCLARI 在歐洲和多個市場獲得批准感到非常高興。當然，在歐洲，由於當地監管部門的批准和定價動態，其成長速度比美國慢。Curium 繼續將該市場商業化。我想正如我們過去所說的那樣，總的來說，我們對 PYLARIFY/PYLCLARI 成為全球品牌並在世界各地的醫學大會上討論的潛力感到非常興奮。

I think from a financial perspective, the relevant impact is minimal in the near term as they continue to ramp. And so we do factor those into our results, but they have a minimal role to date. We are optimistic that that could grow over time, but won't necessarily be a material driver of PYLARIFY performance.

我認為從財務角度來看，由於他們持續增加產能，短期內相關影響微乎其微。因此，我們確實將這些因素考慮進了我們的結果中，但到目前為止，它們的作用很小。我們樂觀地認為，隨著時間的推移，這個數字可能會成長，但不一定會成為 PYLARIFY 業績的物質驅動力。

On the FLYCARDO piece, GE has the commercialization rights. We join and work with them on a joint steering committee. Naturally, the market opportunity is sizable given the number of MPI studies overall. I'll defer specific questions to GE as they are the commercial lead of that agent. But cardiac imaging is a large market in SPECT. It is a sizable market in PET with rubidium. There are benefits of that agent that GE will certainly be talking about.

在 FLYCARDO 方面，GE 擁有商業化權利。我們加入聯合指導委員會並與他們合作。當然，考慮到 MPI 研究的總體數量，市場機會是相當大的。我將把具體問題轉交給通用電氣公司，因為他們是該代理商的商業主管。但心臟影像在 SPECT 中是一個巨大的市場。含銣的 PET 市場規模龐大。通用電氣公司肯定會談論該代理商的優點。

Overall, we're excited for another PET imaging agent that is innovative to come to the marketplace, and we will continue to receive relevant milestones, tiered double-digit royalties in the US, as well as mid-single-digit royalties on sales outside of the US.

總體而言，我們很高興看到另一種創新的PET 成像劑進入市場，我們將繼續獲得相關的里程碑、美國分級兩位數的特許權使用費以及美國以外銷售的中等個位數特許權使用費美國。

Thank you. And ladies and gentlemen, there are no further questions in the queue at this time. Thank you for your participation in today's conference.

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。

This concludes the program. You may now disconnect, and have a wonderful day.

本節目到此結束。現在您可以斷開連接並享受美好的一天。