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Operator
Operator
Good morning. Welcome to Lantheus' first-quarter 2025 conference call. (Operator Instructions) I'll now turn the call over to Mark Kinarney, Vice President of Investor Relations. Mark?
早安.歡迎參加 Lantheus 2025 年第一季電話會議。(操作員指示)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?
Mark Kinarney - Vice President-Investor Relations
Mark Kinarney - Vice President-Investor Relations
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 take your questions.
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)。我們將首先發表準備好的發言,然後回答您的問題。
This morning, we issued a press release which was furnished to the SEC under Form 8-K reporting our first quarter 2025 results. The release and today's slide presentation are available in the Investors section of our website.
今天上午,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 2025 年第一季的表現。該新聞稿和今天的幻燈片演示可在我們網站的“投資者”部分找到。
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.
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。
Brian Markison - Chief Executive Officer, Director
Brian Markison - Chief Executive Officer, Director
Thank you, Mark. And good morning, everyone. Before I dive in to my prepared remarks, I'd like to note our press release from last evening where we announced our plans to divest our SPECT business to SHINE Technologies. I would like to extend my heartfelt thanks to the incredible team that has been with the company from the very beginning and has played a vital role in shaping Lantheus into what it is today.
謝謝你,馬克。大家早安。在我開始準備發言之前,我想提一下我們昨晚發布的新聞稿,我們在新聞稿中宣布了將 SPECT 業務剝離給 SHINE Technologies 的計劃。我要向從一開始就加入公司的優秀團隊表示衷心的感謝,他們在 Lantheus 的形成過程中發揮了至關重要的作用。
In 2025, we've been laying the foundation for the next chapter of our business. We announced two acquisitions in the first quarter, Evergreen Theragnostics and Life Molecular Imaging. Both are designed to fuel our radiopharmaceutical leadership and sustain long-term growth. We closed on Evergreen in early April and expect to close the LMI acquisition in the coming weeks. And as I mentioned, we also announced an agreement to divest our SPECT business.
2025年,我們一直在為業務的下一章奠定基礎。我們在第一季宣布了兩項收購,分別是Evergreen Theragnostics和Life Molecular Imaging。兩者旨在增強我們的放射性藥物領導地位並維持長期成長。我們於 4 月初完成了對 Evergreen 的收購,並預計將在未來幾週內完成對 LMI 的收購。正如我所提到的,我們也宣布了一項剝離 SPECT 業務的協議。
Collectively, these transactions accomplish a number of objectives. First, they add immediate revenue growth drivers that complement our business and diversify our revenue. Second, they had exciting programs in late and early stage development. Third, they add key capabilities, both people and infrastructure, that will enable the company to deliver novel programs from bench to clinic, and ultimately, patients. And finally, they streamline and help focus our organization.
總的來說,這些交易實現了許多目標。首先,它們增加了直接的收入成長動力,補充了我們的業務並使我們的收入多樣化。其次,他們在後期和早期開發階段都有令人興奮的計劃。第三,他們增加了關鍵能力,包括人員和基礎設施,這將使公司能夠將新穎的計畫從實驗室推向臨床,並最終惠及病患。最後,它們簡化並幫助我們集中組織。
This year, we are focused on integrating the Evergreen and LMI businesses and finalizing the divestment of our SPECT business. With a strong cash position and disciplined capital allocation strategy, we are well-positioned to continue investing in our capabilities, advancing and selectively expanding our pipeline, and returning value to shareholders.
今年,我們專注於整合 Evergreen 和 LMI 業務,並最終完成 SPECT 業務的剝離。憑藉強大的現金狀況和嚴謹的資本配置策略,我們有能力繼續投資於我們的能力,推進和選擇性地擴大我們的產品線,並為股東帶來價值。
With that, I'll turn the call over to Paul to give an operational and strategic update.
說完這些,我將把電話轉給保羅,讓他介紹一下營運和策略的最新情況。
Paul Blanchfield - President
Paul Blanchfield - President
Thank you, Brian. I'm pleased to share more about our recent developments. We believe the acquisitions of Evergreen and LMI will strengthen our radiodiagnostic and therapeutic capabilities while expanding our commercial portfolio and pipeline, ultimately enhancing our long-term growth potential.
謝謝你,布萊恩。我很高興與大家分享我們最近的進展。我們相信,收購 Evergreen 和 LMI 將增強我們的放射診斷和治療能力,同時擴大我們的商業組合和管道,最終增強我們的長期成長潛力。
Evergreen enhances our capabilities across the entire value chain with scalable radiotherapeutic manufacturing infrastructure, an early-stage discovery engine, and an expanded pipeline, including OCTEVY, a registrational-stage PET imaging agent targeting neuroendocrine tumors. Evergreen Springfield, New Jersey site and dedicated team will enable us to manufacture our own clinical-stage radiotherapeutics, improve development timelines, and accelerate our pipeline. We also expect to make further investments in this facility and team to enhance our radiodiagnostic expertise and process development capabilities.
Evergreen 透過可擴展的放射治療製造基礎設施、早期發現引擎和擴展的管道(包括針對神經內分泌腫瘤的註冊階段 PET 成像劑 OCTEVY)增強了我們在整個價值鏈中的能力。位於新澤西州斯普林菲爾德的 Evergreen 工廠和專業團隊將使我們能夠生產自己的臨床階段放射治療藥物,改善開發時間表並加速我們的產品線。我們還希望對該設施和團隊進行進一步投資,以增強我們的放射診斷專業知識和流程開發能力。
LMI will provide Lantheus with a commercial radiodiagnostic Alzheimer's franchise, a talented team, and Neuraceq, a globally approved F18 PET imaging agent used to detect beta-amyloid plaques in patients at risk of Alzheimer's disease. We believe that LMI and Lantheus' combined capabilities will support Neuraceq's continued growth in the beta-amyloid radiodiagnostic market and create a scalable and differentiated platform from which to launch all of our Alzheimer's disease PET imaging agents.
LMI 將為 Lantheus 提供商業放射診斷阿茲海默症特許經營權、一支優秀的團隊以及 Neuraceq,這是一種全球認可的 F18 PET 成像劑,用於檢測阿茲海默症風險患者的 β-澱粉樣斑塊。我們相信,LMI 和 Lantheus 的綜合能力將支援 Neuraceq 在 β-澱粉樣蛋白放射診斷市場的持續成長,並創建一個可擴展且差異化的平台,以推出我們所有的阿茲海默症 PET 成像劑。
Alzheimer's disease affects over 50 million people globally and remains an area of significant unmet need for patients, caregivers, providers, and broader society. We believe the Alzheimer's radiodiagnostic market is poised for significant growth, driven by currently-approved therapeutics and over 100 candidates in clinical development targeting beta-amyloid or tau.
阿茲海默症影響著全球超過 5000 萬人,對於患者、照護者、提供者和更廣泛的社會而言,這仍然是一個尚未滿足的重大需求領域。我們相信,阿茲海默症放射診斷市場將迎來顯著成長,這得益於目前已獲批准的治療方法以及針對β-澱粉樣蛋白或 tau 的 100 多種臨床開發候選藥物。
When approved, these therapeutics are expected to increase the need for accurate and timely diagnosis, staging, patient selection, and monitoring of disease. Areas we believe PET imaging is uniquely positioned to address. As such, we believe the USAD radiodiagnostics total addressable market could grow to more than $1.5 billion by the end of the decade and $2.5 billion by the mid-2030s. And we are positioning ourselves to lead in this market with the potential for multiple differentiated PET agents targeting beta-amyloid or tau.
一旦獲得批准,這些療法預計將增加對準確及時的診斷、分期、患者選擇和疾病監測的需求。我們認為 PET 成像具有獨特的優勢可以解決這些領域。因此,我們相信,到本世紀末,USAD 放射診斷總目標市場規模可能會成長到 15 億美元以上,到 2030 年代中期可能成長到 25 億美元。我們將自己定位為該市場的領導者,並具有針對β-澱粉樣蛋白或tau的多種差異化PET藥物的潛力。
Finally, yesterday, we announced an agreement to divest our SPECT business to SHINE Technologies. The SPECT business has been a foundational part of Lantheus' leadership in nuclear medicine, dating back to our days as New England Nuclear. We believe now is the right time to divest the SPECT business as we continue to focus on PET radiodiagnostics, microbubbles, and radiotherapeutic agents. SHINE's isotope production capabilities make them a natural owner of this business, and they are committed to investing in and growing the business. We are grateful to the generations of colleagues who have brought our SPECT products to patients and are confident that the business and these colleagues will be in good hands with SHINE. We expect the transaction to close by the end of this year.
最後,昨天,我們宣布了一項協議,將我們的 SPECT 業務剝離給 SHINE Technologies。SPECT 業務一直是 Lantheus 在核醫學領域領導地位的基礎部分,其歷史可以追溯到我們作為新英格蘭核能公司的時期。我們相信現在是剝離 SPECT 業務的最佳時機,因為我們將繼續專注於 PET 放射診斷、微泡和放射治療劑。SHINE 的同位素生產能力使他們自然而然地成為該業務的所有者,並且他們致力於投資和發展該業務。我們感謝一代又一代的同事將我們的 SPECT 產品帶給患者,並相信在 SHINE 的帶領下,我們的業務和這些同事將會得到良好的發展。我們預計該交易將在今年年底完成。
With that, I'll turn the call over to Amanda to provide our commercial update.
說完這些,我將把電話轉給阿曼達 (Amanda),讓她提供我們的商業更新。
Amanda Morgan - Chief Commercial Officer
Amanda Morgan - Chief Commercial Officer
Thank you, Paul. I'm pleased to share the progress on our commercial portfolio. PYLARIFY sales for the first quarter were $258 million with year-over-year volume growth, offset by low single-digit decline in net price. We have successfully executed our strategy to secure the vast majority of PYLARIFY revenue through strategic partnerships with key hospitals and free-standing imaging centers.
謝謝你,保羅。我很高興分享我們商業投資組合的進展。PYLARIFY 第一季的銷售額為 2.58 億美元,銷量較去年同期成長,但淨價卻出現了個位數的低幅下滑。我們已成功實施我們的策略,透過與主要醫院和獨立影像中心建立策略合作夥伴關係來確保 PYLARIFY 的絕大部分收入。
However, with the expiry of PYLARIFY's pass-through status and the implementation of mean unit cost payment for Medicare FFS in the hospital outpatient setting, we did experience what we believe will be temporal competitive disruption among smaller non-contracted sites.
然而,隨著 PYLARIFY 的直通狀態的到期和醫院門診環境中醫療保險 FFS 平均單位成本支付的實施,我們確實經歷了我們認為將是較小的非合約站點之間的暫時競爭中斷。
We plan to maintain our market leadership and will continue to work through these competitive pressures and grow volume and revenue in 2025. We will achieve this by broadening our contracting efforts while maintaining our pricing premium, expanding product availability in both earlier and later calibration times, educating on PYLARIFY's clinical and commercial differentiation, and continuing to provide superior customer service.
我們計劃保持市場領先地位,並將繼續努力克服這些競爭壓力,在 2025 年增加銷售和收入。我們將透過擴大承包力度同時保持溢價、擴大早期和晚期校準時間的產品可用性、教育 PYLARIFY 的臨床和商業差異化以及繼續提供卓越的客戶服務來實現這一目標。
By 2030, we anticipate the PSMA PET addressable market will exceed $3.5 billion. The key drivers for this growth include the rising incidence and prevalence of the disease, continued conversion of conventional imaging, broader adoption among lower-risk patients, and the expansion of the PSMA-targeted radio ligand therapy.
到 2030 年,我們預計 PSMA PET 目標市場規模將超過 35 億美元。這一增長的主要驅動因素包括疾病發病率和患病率的上升、傳統成像的持續轉變、低風險患者的更廣泛採用以及針對 PSMA 的放射性配體療法的擴展。
We are pleased with the FDA's recent approval of Pluvicto in the pre-chemotherapy mCRPC setting as supported by the PSMA-4 trial results and expect this indication to further increase demand for PSMA PET imaging agents such as PYLARIFY. Notably, Pluvicto's label now references the use of any FDA-approved PSMA PET product for patient selection.
我們很高興看到 FDA 最近批准 Pluvicto 用於化療前 mCRPC 治療,這得到了 PSMA-4 試驗結果的支持,我們預計這一適應症將進一步增加對 PYLARIFY 等 PSMA PET 成像劑的需求。值得注意的是,Pluvicto 的標籤現在提到使用任何 FDA 批准的 PSMA PET 產品進行患者選擇。
We believe there is a market expansion opportunity with our Phase 4 MIRROR study in patients with favorable intermediate risk disease. With this data, our goal is to support future updates to NCCN and SNMMI guidelines to include the use of PSMA PET with PYLARIFY in this patient population, which could in turn expand the addressable market.
我們相信,對於中度風險疾病患者,我們的 4 期 MIRROR 研究具有市場擴展機會。利用這些數據,我們的目標是支持 NCCN 和 SNMMI 指南的未來更新,將 PSMA PET 與 PYLARIFY 結合使用納入該患者群體,從而擴大潛在市場。
DEFINITY remains the number one utilized ultrasound-enhancing agent with more than 20 years in the market and more than 20 million echocardiograms performed. In the first quarter of 2025, DEFINITY achieved approximately $79 million in sales, even with the return of competitive supply to the U.S. market.
DEFINITY 仍然是使用率第一的超音波增強劑,已在市場上銷售 20 多年,並已完成 2000 多萬次超音波心動圖檢查。2025 年第一季度,即使美國市場重新恢復競爭性供應,DEFINITY 仍實現了約 7,900 萬美元的銷售額。
With our two number one imaging agents in PYLARIFY and DEFINITY, we are pleased to continue to serve as the partner of choice for our customers and look forward to the expansion of these relationships with the potential to add Neuraceq in 2025; PNT2003, OCTEVY, and MK-6240 in 2026; as well as NAV-4694 in 2027.
憑藉 PYLARIFY 和 DEFINITY 這兩家領先的成像代理公司,我們很高興能夠繼續成為客戶的首選合作夥伴,並期待擴大這些合作關係,並有可能在 2025 年增加 Neuraceq;2026 年的 PNT2003、OCTEVY 和 MK-6240;以及 2027 年的 NAV-4694。
I will now turn it back to Brian to discuss our development pipeline.
現在我將把話題轉回給 Brian,討論我們的開發流程。
Brian Markison - Chief Executive Officer, Director
Brian Markison - Chief Executive Officer, Director
Thank you, Amanda. We continue to advance our diverse, catalyst-rich pipeline with a focus on assets that are first or best-in-class in oncology, neurology, and cardiology. We believe our neurology pipeline of MK-6240 and NAV, combined with LMI's Neuraceq and PI-2620, positions us well to support the diagnosis, staging, patient selection of therapy, and monitoring of patients with Alzheimer's disease. Our portfolios are highly complementary, and we believe LMI's established commercial franchise provides a platform that will enable us to quickly realize the value of these assets.
謝謝你,阿曼達。我們繼續推動多樣化、富含催化劑的管道,重點關注腫瘤學、神經病學和心臟病學領域的一流或一流的資產。我們相信,我們的 MK-6240 和 NAV 神經病學產品線,結合 LMI 的 Neuraceq 和 PI-2620,使我們能夠很好地支持阿茲海默症患者的診斷、分期、患者治療選擇和監測。我們的投資組合高度互補,我們相信 LMI 成熟的商業特許經營權為我們提供了一個平台,使我們能夠快速實現這些資產的價值。
We recently announced that MK-6240, our next-generation tau imaging agent, met its primary endpoints in two pivotal studies assessing its sensitivity and specificity. We plan to submit a new drug application to the FDA in the third quarter of this year and if approved, look forward to bringing MK-6240 to the market in 2026. Additionally, we remain on track to submit an NDA for NAV in 2026 as well.
我們最近宣布,我們的下一代 tau 成像劑 MK-6240 在評估其敏感性和特異性的兩項關鍵研究中達到了其主要終點。我們計劃在今年第三季向 FDA 提交新藥申請,如果獲得批准,期待在 2026 年將 MK-6240 推向市場。此外,我們也計劃在 2026 年提交 NAV 的保密協議 (NDA)。
We have strengthened our oncology portfolio with the acquisition of Evergreen's OCTEVY which has the potential to create a theranostic pair with PNT2003, our registrational-stage radio-equivalent therapeutic candidate for SSTR-positive gastroenteropancreatic neuroendocrine tumors or GEP-NETs. PNT2003, which has the potential to be the first FDA-approved radio-equivalent to Lutathera, is planned to launch in 2026 pending FDA approval and positive resolution to patent litigation which is ongoing.
我們透過收購 Evergreen 的 OCTEVY 增強了我們的腫瘤學產品組合,OCTEVY 有可能與 PNT2003 形成一種治療診斷組合,PNT2003 是我們針對 SSTR 陽性胃腸胰神經內分泌腫瘤或 GEP-NET 的註冊階段放射等效治療候選藥物。PNT2003 有可能成為第一個獲得 FDA 批准的 Lutathera 放射性等效藥物,計劃於 2026 年上市,但需獲得 FDA 批准並對正在進行的專利訴訟進行積極解決。
Turning to some of our earlier oncology assets, LNTH-2503, which was acquired with Evergreen, is a potentially best and first-in-class theranostic pair targeting the CCK2R receptor. We currently have the diagnostic agent paired with gallium-68 in Phase 2 development, and we are excited to report the Phase 1 therapeutic trial with lutetium-177 is now recruiting patients in Europe.
談到我們早期的一些腫瘤學資產,與 Evergreen 共同收購的 LNTH-2503 是針對 CCK2R 受體的潛在最佳和一流的治療診斷組合。目前,我們已將診斷劑與鎵-68 配對,並處於第 2 階段開發中,我們很高興地報告,使用鎵-177 的第 1 階段治療試驗目前正在歐洲招募患者。
Our theranostic pair for LNTH-2401 and LNTH-2402 includes a gallium-68 imaging agent with a lutetium therapeutic agent targeting GRPR, which is a receptor highly expressed in several tumor types, particularly in prostate cancer. We believe there is a potential for this asset to serve independently and in combination with PSMA since GRPR and PSMA expression are frequently negative correlated. It is important to note that in early disease, GRPR expression is quite similar to PSMA. The diagnostic agent, LNTH-2401, is already in Phase 2 development, and we remain on track to submit an IND for LNTH-2402, the therapeutic candidate.
我們針對 LNTH-2401 和 LNTH-2402 的治療診斷對包括鎵-68 造影劑和針對 GRPR 的镥治療劑,GRPR 是一種在多種腫瘤類型中高度表達的受體,尤其是在前列腺癌中。我們相信,由於 GRPR 和 PSMA 表達通常呈負相關,因此該資產有可能獨立發揮作用並與 PSMA 結合使用。值得注意的是,在早期疾病中,GRPR 表現與 PSMA 非常相似。診斷劑 LNTH-2401 已進入第 2 階段開發階段,我們仍在按計劃提交治療候選藥物 LNTH-2402 的 IND。
LNTH-2403 is a pre-clinical therapeutic agent targeting LLRC15, which is strongly expressed on multiple malignancies, including head and neck, breast, lung, and pancreatic cancers. We are initially focusing on osteosarcoma, for which the FDA has granted both orphan drug and rare pediatric disease designations. Osteosarcoma is a malignant bone tumor that primarily develops in children and teenagers and is the most common childhood bone cancer, with around 1,000 new cases diagnosed annually in the U.S.
LNTH-2403 是一種針對 LLRC15 的臨床前治療藥物,LLRC15 在多種惡性腫瘤中強烈表達,包括頭頸癌、乳腺癌、肺癌和胰腺癌。我們最初專注於骨肉瘤,FDA 已授予該病孤兒藥和兒科罕見疾病稱號。骨肉瘤是一種惡性骨腫瘤,主要發生在兒童和青少年身上,是最常見的兒童骨癌,美國每年約有 1,000 例新病例被診斷出來。
Finally, for PNT2002, the Phase 3 SPLASH study recently reached 100% of pre-specified overall survival events. The results were comparable to the previously reported 46% and 75% readouts, and remained confounded by patient crossover within the study. While we continue to work closely with our partner Eli Lilly to review the full data set, we do not plan to pursue an NDA or further invest in this asset at this time.
最後,對於 PNT2002,第 3 期 SPLASH 研究最近達到了預先指定的總體生存事件的 100%。該結果與先前報告的 46% 和 75% 的讀數相當,並且仍然因研究中的患者交叉而產生混淆。雖然我們將繼續與我們的合作夥伴禮來公司密切合作,審查完整的資料集,但我們目前不打算尋求保密協議或進一步投資該資產。
I will now turn the call over to Bob.
我現在將電話轉給鮑伯。
Robert Marshall - Chief Financial Officer, Treasurer
Robert Marshall - Chief Financial Officer, Treasurer
Thank you, Brian. And good morning, everyone. I will provide highlights of the first quarter of 2025 financials, focusing on adjusted results with comparisons to the prior-year quarter, unless otherwise noted.
謝謝你,布萊恩。大家早安。我將提供 2025 年第一季財務狀況的重點,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。
Turning to the details, consolidated net revenue for the first quarter was $372.8 million, an increase of 0.8%. Radiopharmaceutical oncology, currently, PYLARIFY, contributed $257.7 million of sales, flat with the prior year. Precision diagnostic revenue of $104.4 million was flat year-over-year. Highlights include DEFINITY at $79.2 million, 3.5% higher, along with TechneLite revenue of $19.7 million, down 9.2% due to a brief moly supply issue in March, now resolved.
具體來看,第一季綜合淨營收為3.728億美元,年增0.8%。放射性藥物腫瘤學(目前為 PYLARIFY)貢獻了 2.577 億美元的銷售額,與去年持平。精準診斷收入為 1.044 億美元,與去年同期持平。亮點包括 DEFINITY 的營收為 7,920 萬美元,成長 3.5%,同時 TechneLite 的營收為 1,970 萬美元,由於 3 月份短暫的鉬供應問題(現已解決)而下降 9.2%。
Lastly, strategic partnerships and other revenue was $10.7 million, up 65.1%, due to the continued contribution from use of our investigational asset MK-6240 in third-party clinical trials, up 10.4%, as well as from the recognition of the first sale milestone from (inaudible) of $2 million.
最後,策略夥伴關係和其他收入為 1,070 萬美元,成長 65.1%,這得益於我們在第三方臨床試驗中使用研究資產 MK-6240 的持續貢獻,成長 10.4%,以及首次銷售里程碑(聽不清楚)達到 200 萬美元。
Gross profit margin for the first quarter was 67%, a decrease of 180 basis points. The decrease is attributed to impacts at margins stemming from our strategic partnership contracting initiatives, the annualization of 2024 PMF network and related supply editions, unfavorable PMF network dose volume mix, as well as under absorption of overhead due to the moly supply shortage late in the quarter, partially offset by favorable volumes for PYLARIFY and DEFINITY.
第一季毛利率為67%,下降180個基點。下降的原因是我們的策略合作夥伴承包計劃對利潤率的影響、2024 年 PMF 網路和相關供應版本的年度化、不利的 PMF 網路劑量組合,以及由於本季度末鉬供應短缺導致的間接費用吸收不足,但 PYLARIFY 和 DEFINITY 的有利銷售部分抵消了這一影響。
Operating expenses at 28.3% of net revenue were 147 basis points higher than the prior-year rate and slightly higher than the previously-guided spending levels.
營運費用佔淨收入的 28.3%,比去年同期高出 147 個基點,略高於先前指導的支出水準。
As noted earlier this year, increases in operating expenses reflect investments made to support several growth and efficiency initiatives. Notably, research and development increased 251 basis points to 7.3% of net revenue in support of a number of late- and early-stage development programs. It is worth noting that the company expenses nearly $3 million of business development expenses, largely legal and other third partIES, in support of yesterday's announced divestiture of our SPECT business to SHINE. We do not adjust our management P&L for transaction-related expenses when the deal itself is not signed within the same quarter as incurred, thereby inflating current period.
正如今年稍早所指出的,營運費用的增加反映了為支持多項成長和效率計劃而進行的投資。值得注意的是,研發支出增加了 251 個基點,達到淨收入的 7.3%,以支援一系列後期和早期開發項目。值得注意的是,該公司花費了近 300 萬美元的業務開發費用,主要是法律和其他第三方費用,以支持昨天宣布的將 SPECT 業務剝離給 SHINE。當交易本身不是在發生的同一季度內簽署時,我們不會調整與交易相關的費用的管理損益表,從而誇大當期金額。
Operating profit for the quarter was $144.3 million, a decrease of 7.1%. Other income and expense at $4.6 million of income as a result of interest income offset in part by interest expense on our existing debt.
本季營業利潤為1.443億美元,下降7.1%。其他收入和支出為 460 萬美元,這是由於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 were $52.3 million of expense before taxes. Of this amount, $21.2 million and $8 million of expense is associated with non-cash stock and incentive plans, and acquired intangible amortization, respectively. $14.9 million is a result of unrealized losses tied to our equity investments and perspective and radiopharm theranostics. $5.4 million is related to RM2 milestones. And the remainder relating to acquisition, integration, and other non-recurring expenses.
本季稅前支出總調整額為 5,230 萬美元。其中,2,120 萬美元和 800 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。 1490 萬美元是與我們的股權投資、觀點和放射藥物治療診斷相關的未實現損失的結果。 540 萬美元與 RM2 里程碑相關。其餘部分則與收購、整合和其他非經常性費用有關。
Our effective tax rate was 26.5%. The resulting GAAP net income for the first quarter was $72.9 million and $109.5 million on an adjusted basis, a decrease of 7.5%. GAAP fully diluted earnings per share for the first quarter of $1.02 and $1.53 on an adjusted basis, a decrease of 9.5%.
我們的有效稅率為26.5%。由此產生的第一季 GAAP 淨收入為 7,290 萬美元,調整後為 1.095 億美元,下降 7.5%。第一季 GAAP 完全稀釋每股收益為 1.02 美元,調整後為 1.53 美元,下降 9.5%。
Now during the cash flow, first quarter operating cash flow totaled 107.6 million down $19.7 million from Q1 last year as working capital, particularly DPO metrics, have normalized from the post-SAP implementation environment.
現在在現金流方面,第一季營運現金流總計 1.076 億美元,比去年第一季減少 1,970 萬美元,因為營運資金(特別是 DPO 指標)已從 SAP 實施後的環境中恢復正常。
Capital expenditures totaled $8.7 million, $400,000 lower. Free cash flow, which we define as operating cashless capital expenditures, was $98.8 million, $20.1 million lower for the previously described reasons.
資本支出總計 870 萬美元,減少了 40 萬美元。自由現金流(我們將其定義為無現金經營資本支出)為 9,880 萬美元,由於前面描述的原因,減少了 2,010 萬美元。
During the quarter, the company invested an additional $5 million in [RAD] Equity and deposited $50 million related to the Evergreen acquisition, which closed on April 1. Taken together, cash and cash equivalents, net of restricted cash were $938.5 million at the end of Q1. We have access to our $750 million undrawn bank revolver and are comfortable with our very strong liquidity position.
本季度,該公司向 [RAD] Equity 額外投資了 500 萬美元,並存入了與 Evergreen 收購相關的 5,000 萬美元,該收購於 4 月 1 日完成。總體而言,第一季末的現金和現金等價物(扣除受限現金)為 9.385 億美元。我們可以使用 7.5 億美元未提取的銀行循環信貸,並且對我們非常強大的流動性狀況感到滿意。
We are actively monitoring the recent tariff activity and are working closely with our partners and industry groups to assess any potential impact and advocate for the continued exceptions granted to pharmaceuticals and radioisotopes. This is an evolving situation, but at this juncture, direct impact to our business remains de minimis.
我們正在積極監測最近的關稅活動,並與我們的合作夥伴和行業團體密切合作,評估任何潛在影響,並倡導繼續給予藥物和放射性同位素豁免。情況正在不斷演變,但目前來看,對我們業務的直接影響仍然微乎其微。
Turning now to our updated interim corporate guidance for the full-year 2025. In anticipation of closing the LMI transaction in the next weeks, we are providing an interim view to the business, but we'll update a consolidated view of 2025 after we have closed that transaction.
現在來看看我們更新後的 2025 年全年臨時公司指引。預計在接下來的幾週內完成 LMI 交易,我們將提供對該業務的臨時看法,但我們將在完成交易後更新 2025 年的綜合看法。
That said, our view of PYLARIFY performance for the balance of the year has come into sharper focus. We are updating the implicit PYLARIFY range embedded in the previously guided standalone Lantheus full-year view of revenue. That said, we are shifting our implicit PYLARIFY year-over-year range to flat to low single-digit percent growth for the full year versus our prior view of low single-digit to mid-single-digit growth.
話雖如此,我們對 PYLARIFY 今年餘下時間的表現的看法已經更加清晰。我們正在更新先前指導的獨立 Lantheus 全年收入視圖中嵌入的隱含 PYLARIFY 範圍。也就是說,我們將全年隱含的 PYLARIFY 年比成長範圍調整為持平至低個位數百分比成長,而不是我們先前預測的低個位數至中等個位數成長。
Commentary on all other Lantheus products remains the same. Evergreen adds approximately $10 million of revenue for the balance of the year and reduces adjusted EPS by approximately $0.25, in line with prior dilution guidance. Taken together, revenue is now expected to be $1.55 million to $1.585 billion, ahead of adding in the potential LMI revenue contribution, demonstrating the power of our strategic intent to diversify revenue streams.
所有其他 Lantheus 產品的評論保持不變。Evergreen 在今年剩餘時間內增加了約 1,000 萬美元的收入,並減少了調整後的每股收益約 0.25 美元,這與先前的稀釋指引一致。總體而言,預計收入將達到 155 萬美元至 15.85 億美元,這還不包括潛在的 LMI 收入貢獻,這體現了我們多元化收入來源戰略意圖的力量。
For adjusted EPS modeling purposes, we continue to expect low single-digit dilution from the combined addition of Evergreen and LMI, assuming a consistent share count. The divestiture of the SPECT business should not have any impact on 2025 revenue or earnings, as is expected to close towards the end of the year. But this strategic move should unlock consolidated revenue growth and gross margin expansion in the future.
為了調整 EPS 建模的目的,我們繼續預期 Evergreen 和 LMI 合併後將產生較低的個位數稀釋(假設股份數量保持一致)。SPECT 業務的剝離不會對 2025 年的收入或收益產生任何影響,預計將在年底前完成。但這項策略舉措應能帶來未來的綜合收入成長和毛利率擴大。
Additionally, the company advanced several R&D projects with positive ROI metrics not previously considered in the prior guide. Therefore, R&D should be approximately 7.5% of revenue, up approximately 100 basis points for the full year.
此外,該公司還推進了幾個研發項目,這些項目的投資報酬率指標為正,而這些指標在先前的指南中並未考慮。因此,研發費用應佔營收的約 7.5%,全年成長約 100 個基點。
For now, by only incorporating our PYLARIFY update, R&D investments, and including Evergreen, we now see adjusted EPS in the range of $6.60 to $6.70 versus the prior guide of $7.00 and $7.20. We do expect LMI contribution to the company to be accretive to revenue and earnings immediately. We look forward to providing more specifics after the LMI closing.
目前,僅透過結合我們的 PYLARIFY 更新、研發投資以及 Evergreen,我們現在看到調整後的每股收益在 6.60 美元至 6.70 美元之間,而之前的指導價格為 7.00 美元至 7.20 美元。我們確實預計 LMI 對公司的貢獻將立即增加收入和收益。我們期待在 LMI 結束後提供更多細節。
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。
Brian Markison - Chief Executive Officer, Director
Brian Markison - Chief Executive Officer, Director
Thank you, Bob. We are diversifying our revenues and setting up the business for continued long-term growth. We are driving both commercial and clinical success through our leading diagnostic agents and our diversified pipeline. We are committed to advancing our position as the leading radiopharmaceutical focused company, with both new clinical developments and inorganic growth acquisitions. Remaining the partner of choice for nuclear medicine departments and free-standing imaging centers, delivering sustainable growth, creating long-term value for our shareholders, and bringing innovative products to patients who need them.
謝謝你,鮑伯。我們正在實現收入多元化,並為長期持續成長做好業務準備。我們透過領先的診斷劑和多樣化的管道推動商業和臨床的成功。我們致力於透過新的臨床開發和無機成長收購來提升我們作為領先的放射性藥物重點公司的地位。繼續成為核子醫學部門和獨立影像中心的首選合作夥伴,實現永續成長,為股東創造長期價值,並為需要的患者提供創新產品。
With that, we are ready to take your questions. Operator, please proceed.
現在,我們已準備好回答您的問題。接線員,請繼續。
Operator
Operator
(Operator Instructions)
(操作員指示)
Anthony Petrone, Mizuho Financial Group.
瑞穗金融集團的安東尼‧佩特羅內 (Anthony Petrone)。
Anthony Petrone - Analyst
Anthony Petrone - Analyst
Thanks and good morning everyone. Hope everyone's well. Maybe start with PYLARIFY trends in the quarter. Obviously, good detail in the prepared remarks. But maybe just a little bit more on the competitive dynamics you're seeing out there, certainly by our math, you're looking at a fair amount of share shift here through the March ending quarter. So a little bit on the PYLARIFY competitive dynamics. And I'll have one quick follow-up on gross margin.
謝謝大家,早安。希望大家一切安好。也許從本季的 PYLARIFY 趨勢開始。顯然,準備好的發言稿非常詳細。但也許您再多看看現在看到的競爭動態,根據我們的計算,您會看到截至三月底的季度中,市場份額出現了相當大的變化。關於 PYLARIFY 競爭動態,我們稍微談談。我將快速跟進一下毛利率。
Brian Markison - Chief Executive Officer, Director
Brian Markison - Chief Executive Officer, Director
Okay. Anthony, thanks. We got the questions. I think Paul will lead it off on the reply. Paul?
好的。安東尼,謝謝。我們收到了問題。我認為保羅會率先做出答覆。保羅?
Paul Blanchfield - President
Paul Blanchfield - President
Thanks, Anthony, good morning. I think in the first quarter, I'll add to what we and Amanda provided in the prepared remarks. First, we were successful in securing the vast majority of our revenues through the strategic partnerships. Those, as we've stated before, have largely been with our long-standing and established hospitals and free-standing imaging centers, many of them who have been with us since launch. Those partnerships were key to stabilizing the business, especially amidst the transition to mean unit cost from a Medicare fee-for-service reimbursement perspective. They're also going to serve us incredibly well as we launch a broader portfolio.
謝謝,安東尼,早安。我想在第一季度,我會補充我們和阿曼達在準備好的評論中提供的內容。首先,我們成功地透過策略夥伴關係確保了絕大部分收入。正如我們之前所說,這些客戶大多來自我們長期合作的醫院和獨立影像中心,其中許多客戶自我們成立以來就一直與我們合作。這些合作關係對於穩定業務至關重要,尤其是在從醫療保險按服務收費報銷的角度向平均單位成本轉變的過程中。當我們推出更廣泛的產品組合時,它們也將為我們提供非常好的服務。
In the quarter, we did experience short-term competitive disruption specifically among the smaller non-contracted sites due to MUC-related reimbursement, price, as well as product availability. These smaller sites have been more recent adopters of PSMA PET imaging. And as a result, they have been outpacing the broader PSMA PET market growth. We continue to work through competitive pressures and some of these market dynamics. But we do plan to maintain our market leadership to grow volumes and revenues and to expand our contracting efforts with some of these higher growth later-adopter accounts as well as expanding product availability to ensure that we can continue to meet the growth and ensure our growth grows closer to that of the broader market.
在本季度,我們確實經歷了短期競爭中斷,特別是在較小的非簽約站點之間,原因是與 MUC 相關的報銷、價格以及產品可用性。這些較小的站點最近採用了 PSMA PET 影像。因此,它們的成長速度一直超過更廣泛的 PSMA PET 市場。我們將繼續努力克服競爭壓力和一些市場動態。但我們確實計劃保持我們的市場領導地位,以增加銷售和收入,並擴大我們與一些成長更快的後期採用者的簽約力度,同時擴大產品可用性,以確保我們能夠繼續滿足成長需求,並確保我們的成長更接近更廣泛的市場。
Anthony Petrone - Analyst
Anthony Petrone - Analyst
That's helpful. Go ahead.
這很有幫助。前進。
Brian Markison - Chief Executive Officer, Director
Brian Markison - Chief Executive Officer, Director
Go ahead with your follow-up question.
繼續你的後續問題。
Anthony Petrone - Analyst
Anthony Petrone - Analyst
All good. Thanks, Brian. Maybe just the SPECT sale caught us a little bit by surprise, so maybe just quickly on the rationale to exit SPECT now. And again, on the positive end here, I know you had the MK-6240 headline readout which was positive. When can we expect to see that data? Thanks.
一切都好。謝謝,布萊恩。也許 SPECT 的出售讓我們有點意外,所以也許現在就快速找出退出 SPECT 的理由。再次,從積極的一面來看,我知道您有 MK-6240 的標題讀數,這是積極的。我們什麼時候可以看到這些數據?謝謝。
Brian Markison - Chief Executive Officer, Director
Brian Markison - Chief Executive Officer, Director
Anthony, thank you. Well, on the MK question on the readout of the data, right now, we're all hands on deck to file the new drug application. And then in the not too distant future, we're going to be happy to showcase the data because it is quite positive, which gives us a lot of confidence going in to the submission.
安東尼,謝謝你。好吧,關於 MK 關於數據讀數的問題,現在,我們正全力以赴提交新藥申請。在不久的將來,我們將很高興展示這些數據,因為它非常積極,這給了我們很大的信心去提交。
On the sale of the SPECT business, I think it's important to note that if you look at where we're going. Our recent acquisitions, our pipeline, molecular imaging, theranostic pairs, radio ligand therapies, the SPECT business has been a big anchor for us, but not a core to our future growth. So what we're doing is we're looking to streamline, unlock value, partner that business with a party like SHINE Technologies that is willing to invest further in it. And we will also remain very close to SHINE as they proceed and grow that business. Bob, do you want to add to that a little bit?
關於 SPECT 業務的出售,我認為重要的是要注意,如果你看看我們的發展方向。我們最近的收購、我們的管道、分子成像、治療診斷對、放射性配體療法、SPECT 業務一直是我們的重要支柱,但不是未來成長的核心。因此,我們正在做的是尋求簡化流程、釋放價值,並與 SHINE Technologies 等願意進一步投資的一方合作。隨著 SHINE 業務的推進和發展,我們也將與其保持密切聯繫。鮑勃,你想補充一點嗎?
Robert Marshall - Chief Financial Officer, Treasurer
Robert Marshall - Chief Financial Officer, Treasurer
Yeah. I guess what I would add is maybe sort of like how you think about what this means to the business in terms of it totals about $115 million to $120 million of revenue, it's been a very stable contributor. So that's what I mean when -- as a growth factor, when that comes out of the business, it sort of helps to accelerate the balance of our portfolio which we do think can continue to grow and expand.
是的。我想補充的是,也許有點像您認為這對業務意味著什麼,因為它的總收入約為 1.15 億至 1.2 億美元,它是一個非常穩定的貢獻者。所以這就是我的意思——作為一種成長因素,當它從業務中產生出來時,它有助於加速我們投資組合的平衡,我們確實認為它可以繼續成長和擴大。
The gross margin implications, it's a couple hundred basis points of benefit as we look forward, because the business has a gross margin profile that is much below the company's current average. So again, as Brian noted, this does help to unlock additional value while that business has the potential to grow in SHINE's hands.
從毛利率的角度來看,我們預計未來會有幾百個基點的收益,因為該業務的毛利率遠低於公司目前的平均值。因此,正如 Brian 所指出的,這確實有助於釋放額外的價值,同時該業務有在 SHINE 手中成長的潛力。
Operator
Operator
Roanna Ruiz, Leerink Partners.
Roanna Ruiz,Leerink Partners。
Roanna Ruiz - Analyst
Roanna Ruiz - Analyst
Morning, everyone. So I was curious, I noticed you tightened your fiscal '25 guidance a bit. Could you talk a bit more about what drivers could put you on either the low end or the high end of that guidance by year end? And just tagging on a quick SPECT divestiture question, I assume it probably frees up certain resources and was curious where would you pivot those in terms of contributing to the rest of the commercial or development pipeline?
大家早安。所以我很好奇,我注意到你稍微收緊了 25 年的財務指導。您能否再多談一下,到年底,哪些驅動因素可能會使您的業績達到該指導目標的低端或高端?我只是想快速問一下 SPECT 剝離問題,我認為這可能會釋放某些資源,我很好奇您會將這些資源轉移到哪裡,以便為其餘的商業或開發管道做出貢獻?
Brian Markison - Chief Executive Officer, Director
Brian Markison - Chief Executive Officer, Director
Roanna, could you do me a favor and repeat the second half of that question? I'm not sure I completely got it.
Roanna,你能幫我重複這個問題的後半部嗎?我不確定我是否完全理解了。
Roanna Ruiz - Analyst
Roanna Ruiz - Analyst
Oh sure. With the SPECT business divestiture, I was assuming that you were going to free up certain resources or capital, things like that, where would you want to use those in terms of either the pipeline or commercial efforts?
哦,當然。隨著 SPECT 業務的剝離,我假設您將釋放某些資源或資本等,那麼就管道或商業努力而言,您希望將它們用在何處?
Brian Markison - Chief Executive Officer, Director
Brian Markison - Chief Executive Officer, Director
Got it. I appreciate the clarification. Bob, you want to start off and then Paul will pick it up?
知道了。我很感謝你的澄清。鮑勃,你想先開始,然後保羅來接手嗎?
Robert Marshall - Chief Financial Officer, Treasurer
Robert Marshall - Chief Financial Officer, Treasurer
Yeah. I'll take it from the guidance perspective. Roanna, appreciate the question. We've narrowed the range, but we're now coalescing around the bottom half of the prior range. And it really is about PYLARIFY. So we're still staying with basically what we had previously guided. It's just that, Q1 was extremely informative on how the competitive environment would manage PYLARIFY as we came off pass-through. Our original view actually was a very wide range that contemplated a range of outcomes, with the first half being flattish and then with low single to mid-single-digit, to mid-single to high single-digit-type of an outcome. So all we've done is sort of narrowed this range to be at the bottom, so we're taking the bottom half of that original range. The key thing here though is we do still expect healthy dose volumes throughout the balances of the year. And that is why we landed where we did.
是的。我會從指導的角度來理解。Roanna,感謝您的提問。我們已經縮小了範圍,但現在我們正圍繞先前範圍的下半部分進行合併。這確實與 PYLARIFY 有關。因此我們基本上仍堅持我們先前的指導。只是,當我們擺脫直通式管理時,Q1 非常能說明競爭環境將如何管理 PYLARIFY。我們最初的觀點實際上是一個非常廣泛的範圍,考慮了一系列結果,上半年持平,然後是低個位數到中個位數,到中個位數到高個位數類型的結果。所以我們所做的就是將這個範圍縮小到底部,所以我們取的是原始範圍的下半部。但這裡的關鍵是,我們仍然預計全年的劑量是健康的。這就是我們最終落腳於此的原因。
Paul Blanchfield - President
Paul Blanchfield - President
And Roanna, maybe on your SPECT question, I think we would characterize it really as a couple of things, right, and I'll expand on kind of what Brian and Bob said earlier. But one, this is really about organizational focus. We are ruthlessly prioritizing key growth areas like PET radiodiagnostics and radiotherapeutics, as well as our DEFINITY microbubbles as future growth drivers. So I think it just enables the broader organization to really focus its efforts there.
Roanna,也許關於您的 SPECT 問題,我認為我們可以將其描述為幾件事,對吧,我將詳細闡述 Brian 和 Bob 之前所說的內容。但首先,這其實與組織重點有關。我們堅定不移地將 PET 放射診斷和放射治療以及 DEFINITY 微泡等關鍵成長領域列為未來成長動力。所以我認為這只是讓更廣泛的組織能夠真正集中精力在那裡。
There has naturally been limited investment in the development programs of SPECT. That business is many decades mature. And similarly from a commercial perspective, it's got relatively little complexity, working with just a few key partners. We're incredibly excited for the SHINE team to take on those capabilities and to further invest in that business. And so this is really around who's the best owner and what our organizational focus needs to be to drive continued growth and value creation.
SPECT 開發案的投資自然有限。該業務已成熟數十年。同樣,從商業角度來看,它的複雜性相對較小,只需與幾個關鍵合作夥伴合作。我們非常高興 SHINE 團隊能夠承擔這些能力並進一步投資這項業務。因此,這實際上取決於誰是最好的所有者,以及我們的組織重點需求是什麼,以推動持續成長和價值創造。
And then lastly, there's the financial benefits that Bob mentioned of just -- it's been a relatively stable business with margins below the company average and so this really allows us to unlock the full potential of our financial capabilities and then focus the organization wholeheartedly on our future in PET diagnostics, radiotherapeutics, and microbubbles.
最後,還有鮑勃提到的財務收益——這是一項相對穩定的業務,利潤率低於公司平均水平,因此這確實使我們能夠充分發揮我們的財務能力,然後全心全意地將組織重點放在 PET 診斷、放射治療和微泡的未來上。
Brian Markison - Chief Executive Officer, Director
Brian Markison - Chief Executive Officer, Director
Yeah. And Roanna, I think it's important to note that a number of our colleagues will be going with the SPECT business to SHINE. So if you think about the bigger picture strategically, we're onboarding a team from Evergreen, from Life Molecular Imaging with phenomenal capability in molecular imaging, radiodiagnostics, and therapeutics. And quite frankly, a legacy business that we're not really nurturing and paying that much attention to as we grow the rest of the business is essentially coming out. So moving parts, some leaving, unfortunately; and some coming in, fortunately. And it's really a natural transition of this business all in line with our strategic intent.
是的。Roanna,我認為值得注意的是,我們的許多同事將將 SPECT 業務轉移到 SHINE。因此,如果從策略角度考慮更大的前景,我們將從 Evergreen、Life Molecular Imaging 招募一支團隊,該團隊在分子成像、放射診斷和治療方面擁有非凡的能力。坦白說,隨著我們其他業務的成長,我們並沒有真正培養和關注傳統業務,而是逐漸淡出了我們的生活。因此,不幸的是,有些部件已經移動,有些已經離開了;幸運的是,有些部件正在進來。這確實是該業務的自然轉型,完全符合我們的策略意圖。
Operator
Operator
Richard Newitter, Truist Securities.
Truist Securities 的 Richard Newitter。
Richard Newitter - Analyst
Richard Newitter - Analyst
All right. Thanks for taking the question. I wanted to maybe just ask on the acquisitions. Just looking at 2026, because that's going to be the first full year where these acquisitions will be in there, I think your prior guidance had assumed or your prior comments was low single-digit percent dilution from the combination of LMI and Evergreen. Is that still the right way to think about it? It sounds like you think LMI is going to be accretive right out of the gate. So I'm just wondering if you can give us an update on that. And then also I think last call, you had said you expect 2026 with acquisitions to be a double-digit revenue growth potential year. Is that still in the cards as well? Thank you.
好的。感謝您回答這個問題。我可能只是想問一下有關收購的情況。只看 2026 年,因為那將是這些收購發生的第一個完整年份,我認為您之前的指導已經假設或之前的評論是 LMI 和 Evergreen 合併後的稀釋度百分比為低個位數。這仍然是正確的思考方式嗎?聽起來您認為 LMI 一開始就會增值。所以我只是想知道您是否可以向我們提供有關該問題的最新消息。另外,我想最後說一下,您曾說過,您預計 2026 年透過收購將實現兩位數的收入成長潛力。這還有可能嗎?謝謝。
Brian Markison - Chief Executive Officer, Director
Brian Markison - Chief Executive Officer, Director
Rich, thanks for the question. That is definitely in the cards, and I appreciate you asking. And then Bob, you want to take the rest of the answer?
Rich,謝謝你的提問。這絕對是有可能的,我很感謝你提出這個問題。那麼鮑勃,你想得到剩下的答案嗎?
Robert Marshall - Chief Financial Officer, Treasurer
Robert Marshall - Chief Financial Officer, Treasurer
Yeah. Exactly. The guide for the dilution was low single-digit, but combination of both Evergreen and LMI. That guide also contemplated midyear closing on the deals. We closed early than expected on Evergreen and expect to close on LMI in the next weeks. That all being said, yes, but the $0.25 that we've given to the midpoint of what we had said previously which was at $7.10 is mid-single-digit. That does include about 50 basis points of additional interest income loss. But at the same time, I do fully expect that we would get to low single-digit dilution off that $7.10 number once we've closed on LMI as well. And then update our guidance after we've closed to take that into consideration, both revenue and earnings.
是的。確切地。稀釋指南為低個位數,但結合了 Evergreen 和 LMI。該指南還考慮在年中完成交易。我們比預期提前完成了對 Evergreen 的收購,並預計在未來幾週內完成對 LMI 的收購。話雖如此,但我們給出的 0.25 美元是我們之前所說的 7.10 美元的中間值,這是一個位數的中間值。這確實包括約50個基點的額外利息收入損失。但同時,我確實完全預計,一旦我們完成 LMI 交易,我們將從 7.10 美元的數字中獲得較低的個位數稀釋。然後在交易結束後更新我們的指導方針,將收入和收益都考慮進去。
Operator
Operator
Matt Taylor, Jefferies.
馬特泰勒,傑富瑞。
Matthew Taylor - Analyst
Matthew Taylor - Analyst
Hi. Thank you for taking the question. So I wanted to follow up on some commentary from last quarter. You had talked about in 2026 with the combination of your base business and these acquisitions of Evergreen and LMI being able to sustainably grow in the double digits. And I guess I just wondered if there's any change to that thinking, positive or negative. And maybe you could give us any color around the quantum within the double digits you could grow beyond this year? Thanks.
你好。感謝您回答這個問題。所以我想跟進上個季度的一些評論。您曾談到,到 2026 年,您的基礎業務以及對 Evergreen 和 LMI 的收購將能夠實現兩位數的可持續增長。我想我只是想知道這種想法是否會改變,無論是正面的還是負面的。也許您可以告訴我們今年以後您的成長幅度將在兩位數以內嗎?謝謝。
Brian Markison - Chief Executive Officer, Director
Brian Markison - Chief Executive Officer, Director
Thanks, Matt. I appreciate the question. On the quantum, I think it's a little early on that front. But on double digits, yes. So let me tell you what we're looking at, right? It's the potential launch of OCTEVY with combined potential launch of PNT2003, the potential launch of MK-6240, the full annualization of Neuraceq and our plans to grow it, but more importantly perhaps is the anchored growth with PYLARIFY and DEFINITY which we plan to continue. Guys, did I leave anything out? No. So that's what we're looking at. That's what we're excited about. And that's anchoring our double-digit growth for 2026.
謝謝,馬特。我很感謝你提出這個問題。就量子而言,我認為現在談論這個還為時過早。但就兩位數而言,是的。那麼讓我告訴你我們在看什麼,對嗎?這是 OCTEVY 的潛在推出,結合 PNT2003 的潛在推出,MK-6240 的潛在推出,Neuraceq 的全面年化以及我們發展它的計劃,但更重要的是,我們計劃繼續透過 PYLARIFY 和 DEFINITY 實現穩定成長。夥計們,我有沒有遺漏什麼?不。這就是我們所關注的。這就是令我們興奮的事情。這將為我們 2026 年實現兩位數的成長奠定基礎。
Operator
Operator
Paul Choi, Goldman Sachs.
高盛的保羅·崔(Paul Choi)。
Unidentified Participant
Unidentified Participant
Good morning. This is Daniel, on for Paul. We have two questions. First, are you still thinking that there's a chance that part of this PYLARIFY revenue would switch to ASP pricing this year? And what about the trends for 2026 and beyond? The second question is that after the LMI deal closed, what's the current trend of the PET scan market growth in the Alzheimer's scan market? Thank you.
早安.這是丹尼爾,取代保羅。我們有兩個問題。首先,您是否仍認為 PYLARIFY 的部分收入今年有可能轉向 ASP 定價?那麼 2026 年及以後的趨勢又如何呢?第二個問題是,LMI 交易完成後,阿茲海默症掃描市場中 PET 掃描市場的成長趨勢如何?謝謝。
Brian Markison - Chief Executive Officer, Director
Brian Markison - Chief Executive Officer, Director
Okay. Which one do you want to take first, the Alzheimer's or the PYLARIFY?
好的。您想先參加哪一項,阿茲海默症治療還是 PYLARIFY?
Paul Blanchfield - President
Paul Blanchfield - President
Why don't I touch on the PET scan, Alzheimer's? And then, Amanda can maybe touch on the 2025 and the long-term growth of the PSMA PET --
我為什麼不談一下 PET 掃描和阿茲海默症呢?然後,Amanda 可以談談 PSMA PET 的 2025 年和長期成長——
Brian Markison - Chief Executive Officer, Director
Brian Markison - Chief Executive Officer, Director
Right. And before you do that, we are in constant discussions with CMS and we are working with them. And could ASP emerge rather soon? Yes. But look, it's a little murky down there, so I can't really predict the future. Amanda and the team are really working hard on it. Amanda, you want to comment on that briefly and then we'll switch it over to Paul?
正確的。在您這樣做之前,我們正在與 CMS 進行持續討論並與他們合作。ASP 是否很快就會出現?是的。但你看,那裡有點渾濁,所以我無法真正預測未來。阿曼達和團隊確實為此付出了極大的努力。阿曼達,你想簡單評論一下這個問題然後我們再把話題轉到保羅身上嗎?
Amanda Morgan - Chief Commercial Officer
Amanda Morgan - Chief Commercial Officer
Listen, we're encouraged by our conversations. It is a fluid conversation. What I will share is that the team that we've been communicating with remains the same team as CMS. And as of yet, we've not seen impacts due to recent administration changes.
聽著,我們的談話讓我們深受鼓舞。這是一次流暢的對話。我要分享的是,我們一直溝通的團隊與 CMS 仍然是同一支團隊。到目前為止,我們還沒有看到最近政府變動帶來的影響。
Brian Markison - Chief Executive Officer, Director
Brian Markison - Chief Executive Officer, Director
Great. Right. Paul?
偉大的。正確的。保羅?
Paul Blanchfield - President
Paul Blanchfield - President
So maybe just long term PYLARIFY and the PSMA market, I think we remain very excited about the long term potential. We've highlighted our addressable market potential in 2030 as being $3.5 billion. I think that continues to come into a greater focus and affirmation with the Pluvicto data, as an example, and their approval with PSMA-4. And so I think we're very excited about the long term potential of PSMA PET.
因此,也許只是長期的 PYLARIFY 和 PSMA 市場,我認為我們仍然對長期潛力感到非常興奮。我們強調,2030 年我們的可尋址市場潛力為 35 億美元。我認為,以 Pluvicto 數據為例,這將繼續受到更多關注和肯定,並且 PSMA-4 也批准了這些數據。因此我認為我們對 PSMA PET 的長期潛力感到非常興奮。
From a pricing perspective, near term, strategic partnerships are going to anniversary largely in the first half of this year which will set us up for more support in the long term growth. And so I think we remain optimistic about the overall PSMA PET market and the long term potential for PYLARIFY. Especially as we broaden the portfolio to be the go-to partner for hospitals and free-standing imaging centers. We have the potential to have the largest and broadest innovative portfolio to work with those sites to expand our strategic partnerships and continue to support that continued growth.
從定價角度來看,短期內,策略夥伴關係將在今年上半年基本達到週年紀念日,這將為我們的長期成長提供更多支持。因此我認為我們仍然對整個 PSMA PET 市場和 PYLARIFY 的長期潛力持樂觀態度。特別是當我們擴大產品組合以成為醫院和獨立影像中心的首選合作夥伴時。我們有潛力擁有最大、最廣泛的創新組合,與這些網站合作擴大我們的策略合作夥伴關係,並繼續支持持續成長。
And that includes Alzheimer's. Clearly, Life Molecular remains a separate organization under Life Healthcare today, but just monitoring the trends of overall claims data as a result of Alzheimer's scans, specifically for beta-amyloid, but increasingly for tau. We see very robust growth in that marketplace. And when we think combining the terrific team and capabilities of LMI with that of Lantheus and our deep F18 expertise and experience with customers, we're very optimistic about the opportunity in Alzheimer's with Neuraceq as well as MK-6240, NAV-4694, and PI-2620 to have a broad deep portfolio on Alzheimer's that can be a very meaningful franchise for us.
其中包括阿茲海默症。顯然,Life Molecular 如今仍然是 Life Healthcare 旗下的一個獨立組織,但只是監測阿茲海默症掃描結果的整體索賠數據趨勢,特別是針對 β-澱粉樣蛋白,但越來越多地針對 tau。我們看到該市場成長非常強勁。當我們考慮將 LMI 的優秀團隊和能力與 Lantheus 的優秀團隊和能力以及我們在 F18 方面的深厚專業知識和客戶經驗結合起來時,我們對 Neuraceq 以及 MK-6240、NAV-4694 和 PI-2620 在阿茲海默症領域的機會非常樂觀,在阿茲海默症中擁有阿茲海默症的產品領域的廣泛意義。
Operator
Operator
Larry Solow, CJS Securities Inc.
索洛(Larry Solow),CJS 證券公司
Lawrence Solow - Analyst
Lawrence Solow - Analyst
Good morning. Thanks for taking the question. First question just on the gross margin and a little bit higher cost. You mentioned the issue with TechneLite. Was gross margin impacted at all just by the, I guess, the overall price discounting on PYLARIFY? And is PYLARIFY pricing kind of in line with how you expect it to be so far?
早安.感謝您回答這個問題。第一個問題是關於毛利率和稍微高一點的成本。您提到了 TechneLite 的問題。我猜,PYLARIFY 的整體價格折扣是否對毛利率產生了影響?PYLARIFY 的定價是否與您目前的預期一致?
Robert Marshall - Chief Financial Officer, Treasurer
Robert Marshall - Chief Financial Officer, Treasurer
Yes. I mean, particularly when they gave the sort of the explanation for the quarter on a year-over-year basis. That does have an impact on the margin from the strategic partnerships and so forth. But there were a handful of other things that I mentioned in terms of cost. When you think about maybe relative to what we had expected, the real drivers from what our original expectations of 67.5% to 68%, why was it not there? It really kind of came down to just a couple of different factors really. One, rate cost were higher. But also the dose volume mix in our PMF network. And what that does is depending on the mix of PYLARIFY, where and which of the different networks, they're not all the same. So that mix did drive some of it from expectations. But again, going back to the pricing aspect, we still remain at a price premium to our competitors. And so from an expectation perspective, that was sort of what we had expected.
是的。我的意思是,特別是當他們對本季的同比表現做出解釋時。這確實會對策略夥伴關係等的利潤產生影響。但在成本方面我還提到了一些其他的事情。當您思考相對於我們預期的情況時,我們發現真正的驅動因素與我們最初預期的 67.5% 至 68% 之間相差甚遠,為什麼它沒有出現呢?事實上,這可以歸結為幾個不同的因素。一是費率成本較高。而且還有我們 PMF 網路中的劑量體積混合。而這取決於 PYLARIFY 的混合情況、不同的網路位置和類型,它們並不完全相同。因此,這種混合確實推動了部分預期。但再次回到定價方面,我們的價格仍高於競爭對手。因此,從預期的角度來看,這正是我們所預期的。
Operator
Operator
Yuan Zhi, B. Riley.
袁志,B.萊利。
Yuan Zhi - Analyst
Yuan Zhi - Analyst
Good morning. Thank you for taking our questions. Maybe to ask on this question a bit differently, can you please comment more on the effect of this long-term contract you signed? For clients in that bucket, do they grow in volume of PYLARIFY faster than others, than if we compare the growth rate across academic centers and the community centers? Is there a difference in terms of growth and market penetration? Thank you.
早安.感謝您回答我們的問題。也許我們可以換個方式來問這個問題,您能否就您簽署的這份長期合約的效果發表更多評論?對於該類別中的客戶,如果我們比較學術中心和社區中心的成長率,他們的 PYLARIFY 數量成長是否比其他客戶更快?在成長和市場滲透方面是否存在差異?謝謝。
Paul Blanchfield - President
Paul Blanchfield - President
Yuan, thank you for the question. I think it's very astute. There is certainly a difference in the growth and utilization across the marketplace. We're coming up on four years since approval and launch. We saw some very early adoption amongst leading academics and large-scale free-standing imaging centers. The utilization of PYLARIFY and quite honestly, other PET CT agents, those have been early adopters. And so their utilization rates are far higher than, say, other parts of the market. And in some cases, that has led to patient wait times. Whereas some of the smaller non-contracted accounts are growing higher than the overall market because they've been later adopters and are earlier in their adoption curves.
袁先生,謝謝你的提問。我認為這是非常精明的。整個市場的成長和利用率肯定存在差異。自從批准和啟動以來,我們已經過去四年了。我們看到一些領先的學術機構和大型獨立成像中心很早就採用了這項技術。PYLARIFY 的使用以及其他 PET CT 藥劑,都是早期採用者。因此,它們的利用率遠高於市場的其他部分。在某些情況下,這會導致患者等待更長時間。而一些規模較小的非簽約帳戶的成長速度高於整體市場,因為他們採用得較晚,而且採用曲線處於早期階段。
And so I do think we see a difference in overall utilization. Our focus had been to secure the vast majority of PYLARIFY revenues through strategic partnerships. We believe we've been very successful with that. And our current evolution is to now increasingly focus on those smaller non-contracted sites that present more near term growth opportunities.
因此我確實認為我們看到了總體利用率的差異。我們的重點是透過策略夥伴關係確保 PYLARIFY 的絕大部分收入。我們相信我們在這方面取得了巨大的成功。我們目前的發展方向是越來越關注那些在短期內能帶來更多成長機會的小型非簽約站點。
And so to some extent, this really comes down to mix and our steadfast focus on securing the vast majority of the business and now, evolving to focus on expanding our contracts with smaller accounts to expanding our out-the-door times to meet growth where it is for those accounts. And that's what we're busy doing on a regular basis now.
因此,從某種程度上來說,這實際上歸結為組合,我們堅定不移地專注於確保絕大多數業務,現在,我們逐漸將重點放在擴大與較小帳戶的合約上,延長我們的外出時間,以滿足這些帳戶的增長。這正是我們現在經常忙於做的事情。
Operator
Operator
Justin Walsh, Jones Trading.
賈斯汀·沃爾什,瓊斯貿易公司。
Justin Walsh - Analyst
Justin Walsh - Analyst
Hi. Thanks for taking the question. Can you discuss how you view the long term opportunity for the GRPR-targeting imaging and therapy in prostate cancer? Specifically, I'm wondering if there's expected clinical value for imaging GRPR outside of enabling the therapeutic or if that's the key feature there. And if you'd expect therapeutic use ultimately to be in the post PSMA setting?
你好。感謝您回答這個問題。您能否討論一下您如何看待前列腺癌 GRPR 標靶影像和治療的長期機會?具體來說,我想知道除了實現治療之外,成像 GRPR 是否還有預期的臨床價值,或者這是否是其關鍵特徵。您是否希望最終的治療用途是在 PSMA 之後?
Brian Markison - Chief Executive Officer, Director
Brian Markison - Chief Executive Officer, Director
Great question. Let me start sort of at the beginning. In early prostate carcinoma, GRPR expression is quite avid and quite similar to PSMA expression. And what we find fascinating about the agent or the target is where one over-expresses, the other could be under-expressing. So in other words, if you get into later lines of therapy, if PSMA expression is down or depressed, GRPR expression could be quite high and there could be a fair amount of avidity there for a radio ligand therapy.
好問題。讓我從頭開始講。在早期前列腺癌中,GRPR 表達相當活躍,與 PSMA 表達非常相似。我們發現,關於代理或目標的有趣之處在於,一個過度表達,而另一個可能表達不足。換句話說,如果您進入後期治療,如果 PSMA 表達下降或受到抑制,GRPR 表達可能相當高,並且對放射性配體療法的親和力可能會相當高。
The gallium diagnostic agent is in Phase 2 right now, and we're exploring separate fast-track opportunities to see if we can bring that to the market earlier. I think there will be an interesting role for the imaging agent in and apart from the therapeutic. And I think with the therapeutic, we're focused right now on getting the IND filed and also getting into the clinic as soon as practical in Phase 1. And we think there's going to be a very interesting role. Because ultimately, these radio ligand therapies are not going to be used as single agents. They will be used in combination, like any other therapeutic modality in oncology. And we think they'll be additives. So there could be a very interesting role both in very early, mid-, and late-term, prostate cancer disease for the therapy and also for the diagnostic.
鎵診斷劑目前處於第二階段,我們正在探索單獨的快速通道機會,看看是否可以更早將其推向市場。我認為成像劑在治療中以及治療之外還將發揮有趣的作用。我認為,就治療而言,我們現在專注於提交 IND 申請,並儘快在第一階段進入臨床。我們認為這將是一個非常有趣的角色。因為最終,這些放射性配體療法不會被用作單一藥物。它們將聯合使用,就像腫瘤學中的任何其他治療方式一樣。我們認為它們會成為添加劑。因此,對於早期、中期和晚期前列腺癌的治療和診斷來說,它可能發揮非常有趣的作用。
Operator
Operator
Kemp Dolliver, Brookline Capital Markets.
布魯克林資本市場 (Brookline Capital Markets) 的 Kemp Dolliver。
Kemp Dolliver - Analyst
Kemp Dolliver - Analyst
All right. Thank you. On the smaller accounts in the market for PYLARIFY, are these accounts that are operating essentially on a spot basis or are they contracted with others? I'm trying to reconcile your position as a premium price product with what looks like a customer base that might have a commodity mindset. So can you reconcile that for me?
好的。謝謝。對於 PYLARIFY 市場上較小的帳戶,這些帳戶基本上是按現貨方式運營的還是與其他帳戶簽訂了合約?我試圖將您的高價產品定位與可能具有商品心態的客戶群相協調。那你能幫我解決這個問題嗎?
Brian Markison - Chief Executive Officer, Director
Brian Markison - Chief Executive Officer, Director
Yeah. I think we're looking at it a little bit differently. I think as we have grown our business and matched that with our growing PMF network, we have 63 PMFs up and running in the country. And our strategic contracts were designed to partner us for the long term with our highest volume early adopters. And I think what we're seeing is the smaller accounts that now have some capacity were not initially our early focus as we were dealing with the major institutions. Amanda, do you want to expand on that a little bit?
是的。我認為我們對此的看法有點不同。我認為,隨著我們業務的成長以及 PMF 網路的不斷擴大,我們在全國範圍內已建立並運營了 63 個 PMF。我們的策略合約旨在與我們數量最多的早期採用者建立長期合作夥伴關係。我認為,我們看到的是,現在具有一定容量的小帳戶最初並不是我們關注的重點,因為我們當時正在與主要機構打交道。阿曼達,你想稍微詳細解釋一下嗎?
Amanda Morgan - Chief Commercial Officer
Amanda Morgan - Chief Commercial Officer
Yeah. Thanks, Brian. That's exactly right. As Paul shared in his prepared remarks, as we continue to evolve in the market, we are continuing to grow and expand our product availability. And that'll be through our earlier and later calibration times. That will enable us to not only partner, as Brian said, with our largest strategic accounts, but also partner with the smaller accounts, so those later adopters that are continuing other uptake of of PSMA PET.
是的。謝謝,布萊恩。完全正確。正如保羅在他的準備好的演講中分享的那樣,隨著我們在市場上的不斷發展,我們也在不斷發展和擴大我們的產品供應。這將透過我們較早和較晚的校準時間來實現。正如 Brian 所說,這將使我們不僅能夠與最大的策略客戶合作,而且還能與較小的客戶合作,因此那些後來的採用者將繼續採用 PSMA PET。
Operator
Operator
Frances Dovell, TD Securities.
法蘭西斯‧多維爾 (Frances Dovell),道明證券。
Frances Dovell - Analyst
Frances Dovell - Analyst
Hi. This is Frances, on Tara. Can you elaborate on the extent of the MUC-based pricing impacts on revenue this quarter compared to other factors like the net pricing impacts? And are you still guiding to the MUC pricing affecting only about 10% of the total patients?
你好。我是塔拉的弗朗西斯。您能否詳細說明與淨定價影響等其他因素相比,基於 MUC 的定價對本季營收的影響程度?您是否仍在指導僅影響約 10% 總患者的 MUC 定價?
Paul Blanchfield - President
Paul Blanchfield - President
Thanks for the question. So the MUC-based pricing remains impacting about 20% of patients. That is the overlap or intersection, I should say, between Medicare fee-for-service, relative to Medicare Advantage or commercial payers, and then in the hospital outpatient setting. So that's still around 20% of patients overall when you look at that. I would say, I think when we look at the quarter and some of the dynamics, we looked at MUC pricing, we looked at competitive pricing, as well as product availability in some cases. Fundamentally, I think it's hard to break down into those three because they ultimately all intersect on the impact of customers as well as the adoption or growth curves in there. And so I think they all had a bit of an issue.
謝謝你的提問。因此基於 MUC 的定價仍然影響著約 20% 的患者。我應該說,這就是醫療保險按服務收費與醫療保險優勢計劃或商業付款人以及醫院門診環境之間的重疊或交集。因此從這個角度來看,總體而言,這仍然佔患者總數的 20% 左右。我想說,我認為當我們觀察季度和一些動態時,我們會觀察 MUC 定價、競爭性定價以及某些情況下的產品可用性。從根本上來說,我認為很難將其分解為這三者,因為它們最終都會在客戶的影響以及其中的採用或成長曲線上相交。所以我認為他們都遇到了一些問題。
I would say, MUC is likely more of a transitory impact as customers understand based on the payment timing of claims from Medicare. It does take them a little bit of time to understand what that looks like. The MUC/ASP dynamics coming from CMS were quite volatile in the months leading up to January 1 with a number of adjustments to the addendums coming out there. And so I do think it took some time for sites to understand that. We think sites have a pretty good understanding of their book of business, and that should stabilize over time. And then our continued differentiation and availability of PYLARIFY, plus our broadening portfolio will support our continued growth.
我想說,MUC 可能更像是暫時的影響,因為客戶是根據 Medicare 索賠的支付時間來理解的。他們確實需要一點時間來理解那是什麼樣子。在 1 月 1 日之前的幾個月裡,CMS 的 MUC/ASP 動態相當不穩定,並且對附錄進行了一些調整。所以我確實認為網站需要一些時間來理解這一點。我們認為網站對其業務有相當好的了解,隨著時間的推移,這種了解應該會趨於穩定。然後,我們對 PYLARIFY 的持續差異化和可用性,加上我們不斷擴大的產品組合將支持我們的持續成長。
Operator
Operator
Andy Hsieh, William Blair.
安迪謝、威廉布萊爾。
Andy Hsieh - Analyst
Andy Hsieh - Analyst
Great. Thanks for taking our questions. We're curious about your long-term view on the Alzheimer's diagnostic market, specifically pertaining to the encroachment of serum-based biomarkers for diagnostic purposes. So Biogen, on the first quarter call, they mentioned for the potential for blood-based markers to potentially supplant the need for PET scans. So I'm just curious if you can comment on that and potentially provide your view there. And a quick follow-up for your 2030 PYLARIFY revenue guidance, I understand that PSMA addition opportunities is included and that's reading out later this year. But could you help us understand the growth potential for PSMA (inaudible) and some of the activity to buy assets that's moving earlier lines and recently moved to Phase 3 trials? Thank you.
偉大的。感謝您回答我們的問題。我們很好奇您對阿茲海默症診斷市場的長期看法,特別是關於基於血清的生物標記在診斷用途上的侵蝕。因此,Biogen 在第一季電話會議上提到,血液標記物有可能取代 PET 掃描的需要。所以我只是好奇您是否可以對此發表評論並提供您的觀點。另外,請快速跟進一下您對 2030 年 PYLARIFY 收入的指導,我了解到其中包括 PSMA 附加機會,這將在今年稍後公佈。但是您能否幫助我們了解 PSMA(聽不清楚)的成長潛力以及購買早期產品線和最近進入第 3 階段試驗的資產的一些活動?謝謝。
Brian Markison - Chief Executive Officer, Director
Brian Markison - Chief Executive Officer, Director
All right. So I'll kick it off with the Alzheimer's answer and turn it over to Paul. First, on serology, blood-based biomarkers, I think they're very important. And I think if you look at the prostate market, you have PSA as a legitimate marker for detection, follow-up, et cetera, for the disease. And I would think in AD or Alzheimer's disease, you'd see a similar pattern, hopefully, where people will get screened with serology and then become candidates for a PET scan or molecular imaging.
好的。因此我將從阿茲海默症的答案開始,然後將其交給保羅。首先,關於血清學,基於血液的生物標記物,我認為它們非常重要。我認為,如果你看一下前列腺市場,你會發現 PSA 是該疾病的檢測、追蹤等合法標記。我認為在阿茲海默症或阿茲海默症中,你會看到類似的模式,希望人們能通過血清學篩檢,然後成為 PET 掃描或分子影像的候選人。
I think when you compare them, there is no comparison, right? Molecular imaging gives you quantification. It gives you geography. It gives you correlation to treatment outcome and effect. So none of the serology markers can actually do that, they're not that sensitive, nor are they specific. So if you're looking at specific regions of the brain, for example, with MK-6240, and looking at longitudinal follow-up or you're looking at what parts of the brain are mostly affected by the NFTs, serology can never do that, at least in my current lifetime, I think.
我認為當你比較它們時,就沒有可比性了,對嗎?分子成像可以為您提供量化資訊。它為你提供地理知識。它為您提供治療結果和效果的關聯性。因此,沒有任何血清學標記可以真正做到這一點,它們不那麼敏感,也不那麼具體。因此,如果您使用 MK-6240 觀察大腦的特定區域,並進行縱向跟踪,或者觀察大腦哪些部分最容易受到 NFT 的影響,那麼血清學永遠無法做到這一點,至少在我現在的有生之年是這樣,我想。
So while I appreciate comments from others, I think maybe they're not totally informed, but there's no comparison with molecular imaging and serology. I think serology is a great tool. It's cost effective. It should be used as a screening mechanism. But if you want to know what's happening inside the brain with Alzheimer's, dementia, and geography, follow-up, effects of treatment, you really need a molecular imaging scan with beta-amyloid and tau.
因此,雖然我很欣賞其他人的評論,但我認為他們可能並不完全了解,但與分子成像和血清學沒有可比性。我認為血清學是一種很好的工具。它具有成本效益。它應該被用作一種篩選機制。但如果你想知道阿茲海默症、失智症以及地理、後續治療、治療效果在大腦內部發生的情況,你真的需要使用β-澱粉樣蛋白和tau進行分子影像掃描。
Paul Blanchfield - President
Paul Blanchfield - President
Maybe I'll just add on that and then I'll pivot to the PYLARIFY piece. 100% agree with what Brian just said. I guess I would just add, Andy, when you look at payers looking at roughly mid-$30,000 a year therapeutic cost, over multiple years, it's not hard to imagine that as a payer and a physician looks at saying putting on someone in therapy that may cost $100,000 over three years, the desire to not just do a blood test, but to do a couple-thousand-dollar PET scan, that's quite smart money to really understand the location and extent of disease and to effectively monitor that. And so we think there's a symbiotic relationship between serological markers and imaging, the same way we see with PSA from a serological test and PSMA.
也許我只會補充這一點,然後轉向 PYLARIFY 部分。 100%同意 Brian 剛才所說的。我想補充一點,安迪,當你看到付款人多年來每年的治療費用約為 30,000 美元時,不難想像,作為付款人和醫生,讓某人接受三年內可能花費 100,000 美元的治療,不僅希望進行血液測試,還希望進行幾千美元的 PET 掃描,這筆錢是相當明智的位置,可以真正了解疾病的位置和對其疾病的位置進行監測。因此,我們認為血清學標記和成像之間存在共生關係,就像我們從血清學測試中看到的 PSA 和 PSMA 一樣。
I think on your earlier question on the PSMA therapeutic market, I think we may be very encouraged, not only with Novartis' results with PSMA-4, but PSMA addition which we're optimistic about, as well as you said, there are dozens of candidates targeting PSMA from a radio ligand therapy. And that really underscores our addressable market view where the scans associated with RLP could go from roughly, 30,000, I believe, to almost 200,000 by the end of the decade.
我認為關於您之前關於 PSMA 治療市場的問題,我認為我們可能會感到非常鼓舞,不僅是因為諾華在 PSMA-4 方面取得了成果,而且我們對 PSMA 附加療法也持樂觀態度,而且正如您所說,有數十種針對 PSMA 的放射性配體療法候選藥物。這確實強調了我們針對目標市場的觀點,即到本世紀末,與 RLP 相關的掃描數量可能會從大約 30,000 次增加到近 200,000 次。
Current RLT patient selection only makes up single digits for PSMA PET use. We think that can expand, not only with RLT, but also with antibody drug conjugates and other therapeutics targeting PSMA. And so we think there's continued benefit in the molecular imaging and the ability to find and follow disease, not only with PYLARIFY, but with Alzheimer's, as Brian mentioned.
目前,RLT 患者選擇僅佔 PSMA PET 使用人數的個位數。我們認為這不僅可以擴展到 RLT,還可以擴展到抗體藥物偶聯物和其他針對 PSMA 的療法。因此,我們認為分子成像以及發現和追蹤疾病的能力將持續帶來益處,不僅對於 PYLARIFY 如此,對於阿茲海默症也是如此,正如 Brian 所提到的。
Operator
Operator
David Turkaly, Citizens JMP.
David Turkaly,公民 JMP。
David Turkaly - Analyst
David Turkaly - Analyst
Good morning. There was lots of debate heading in about the changes that might happen with the reimbursement and then debates about sort of clients, customers switching. And it sounds like you're saying these smaller centers maybe never use PYLARIFY and now you're going to focus on them, but despite discussions of whether these images, scans might be apples to apples or not. We're just curious, have you seen any evidence of switching either at the large accounts or the small accounts or even on a patient basis so far?
早安.關於報銷方面可能發生的變化以及客戶、顧客轉換等問題存在大量爭論。聽起來您好像在說這些較小的中心可能從未使用過 PYLARIFY,現在您要專注於它們,但儘管討論了這些圖像、掃描是否相同。我們只是好奇,到目前為止,您是否看到過大帳戶、小帳戶甚至病患帳戶轉換的證據?
Brian Markison - Chief Executive Officer, Director
Brian Markison - Chief Executive Officer, Director
Yeah. Great question, and I appreciate it. I think if you look at our later adopters, smaller accounts, that we have not focused on, there has been a bit of what I would call stroke of the pen risk with them switching over to other agents, (inaudible), whatever, gallium. And we really focused again, as we've said repeatedly on our major accounts, right, those that have the majority of the volume and also providing the most cutting-edge treatment. I think in the smaller accounts, again, and we know where every dose is going because our PMF partners are doing a great job delivering those doses. If they're doing one or two scans a week, we're not going to drop everything and go visit them. So naturally, they're open to a dialogue about price if that's all that matters to them.
是的。這個問題問得非常好,我很感激。我認為,如果你看看我們後來的採用者,那些我們沒有關注的小帳戶,他們轉向其他代理商(聽不清楚)時,存在一些我稱之為「筆觸風險」的風險,不管怎樣,都是鎵。正如我們反覆強調的,我們再次將重點放在主要客戶上,對吧,那些擁有大部分交易量並且提供最前沿治療的客戶。我認為在較小的帳戶中,我們知道每一劑藥物的去向,因為我們的 PMF 合作夥伴在提供這些劑量方面做得很好。如果他們每週進行一到兩次掃描,我們不會放下一切去拜訪他們。因此,如果價格對他們來說很重要的話,他們自然願意就價格問題進行對話。
Operator
Operator
John Vandermosten, Zacks.
約翰·范德莫斯滕,Zacks。
John Vandermosten - Analyst
John Vandermosten - Analyst
Thank you and good morning. Two for me. First, under what conditions does it make sense to launch a generic competitor to a branded pharmaceutical? And then second, what are some of the leading candidates in development that would benefit from MK-6240 and PI-2620?
謝謝,早安。對我來說是兩個。首先,在什麼條件下推出仿製藥來與品牌藥競爭才有意義?其次,哪些處於開發階段的領先候選藥物將從 MK-6240 和 PI-2620 中受益?
Brian Markison - Chief Executive Officer, Director
Brian Markison - Chief Executive Officer, Director
John, I apologize, but you were breaking up on the line. And I hate to do this, but could you please repeat the questions?
約翰,我很抱歉,但你在電話裡說分手了。我不想這樣做,但是你能重複問題嗎?
John Vandermosten - Analyst
John Vandermosten - Analyst
Apologies. Under what conditions does it make sense to launch a generic competitor to a branded radiopharmaceutical? And the follow-up was, looking at the leading tau candidates in development right now, which ones might benefit from MK-6240 and PI-2620, the therapeutic side, what you're looking at?
抱歉。在什麼條件下推出品牌放射性藥物的仿製藥才有意義?後續問題是,看看目前正在開發的領先的 tau 候選藥物,哪些可能受益於 MK-6240 和 PI-2620,在治療方面,您正在研究什麼?
Brian Markison - Chief Executive Officer, Director
Brian Markison - Chief Executive Officer, Director
Well, I think on the tau agents and also our NAV beta-amyloid, because of their greater sensitivity and specificity, any therapeutic candidate that's in the clinic right now in trials will certainly benefit from better patient selection and follow-up. For example, both MK and NAV have the potential to detect very early centiloid count. And they're actually, quite frankly, more sensitive than blood biomarkers.
嗯,我認為,由於 tau 藥物和我們的 NAV β-澱粉樣蛋白具有更高的敏感性和特異性,因此目前在臨床上進行試驗的任何治療候選藥物肯定都會受益於更好的患者選擇和隨訪。例如,MK 和 NAV 都有可能檢測到非常早期的中央細胞計數。坦白說,它們實際上比血液生物標記物更敏感。
MK-6240 right now is in 103, approximately, academic trials around the world and over 15 sponsored trials with major pharma partners. And we're working very closely with Jansen, Roche, and others, Merck, obviously, to name a few, to explore and help them clarify, detect, and put patients into clinical trials for their therapeutics. On the generic radio-equivalent question, Paul would love to take that question.
MK-6240 目前在全球進行約 103 項學術試驗,並與主要製藥合作夥伴進行 15 多項贊助試驗。我們正在與楊森、羅氏以及其他公司(顯然是默克公司)密切合作,探索並幫助他們明確、檢測並讓患者參與其治療方法的臨床試驗。關於一般無線電等效問題,保羅很樂意回答這個問題。
Paul Blanchfield - President
Paul Blanchfield - President
Thanks for the question. So on launching our radio-equivalent for PNT2003, first and foremost, we always look at our appropriate return metrics to ensure that we're going to generate a return north of our weighted average cost of capital. So we don't just look for growth at any sort. We're looking to ensure we have a positive financial return from those investments. When we look at the Lutathera opportunity, it is a sizable market. We're pleased with their NETTER-2 results that we believe could make this a very sizable market. And so there's certainly a role for additional products in that space.
謝謝你的提問。因此,在推出 PNT2003 的無線電等效產品時,我們首先要考慮的是適當的報酬指標,以確保我們產生的報酬高於加權平均資本成本。因此,我們不只是尋求任何形式的成長。我們希望確保從這些投資中獲得正的財務回報。當我們審視 Lutathera 的機會時,我們發現這是一個相當大的市場。我們對他們的 NETTER-2 結果感到滿意,我們相信這將是一個非常大的市場。因此,附加產品在該領域肯定發揮作用。
When we look at the ability to combine that with OCTEVY into a theranostic pair, we think that could be a meaningful addition to the marketplace. And in addition, it further expands our relationships with nuclear medicine departments and hospitals that are already using, say, PYLARIFY on their PET CTs, that may already be using Neuraceq. And so we think this is a good opportunity and we're focused on bringing this to the market. But suffice it to say, we look very closely at the conditions, at demand studies, at market research to ensure that there is a positive return to the investments that we're making. And we remain optimistic about that ability to bring OCTEVY and PNT2003 as a theranostic-like pair next year.
當我們考慮將其與 OCTEVY 結合形成治療診斷組合時,我們認為這可能會為市場帶來有意義的補充。此外,它進一步擴大了我們與核醫學部門和醫院的關係,這些部門和醫院已經在 PET CT 上使用 PYLARIFY,可能已經在使用 Neuraceq。因此我們認為這是一個很好的機會,我們致力於將其推向市場。但可以說,我們非常仔細地研究條件、需求研究和市場調查,以確保我們所做的投資能帶來正面的回報。我們仍然對明年將 OCTEVY 和 PNT2003 結合成一對治療診斷學組合的能力持樂觀態度。
Operator
Operator
Richard Newitter, Truist Securities.
Truist Securities 的 Richard Newitter。
Richard Newitter - Analyst
Richard Newitter - Analyst
Hi. Thanks for the follow-up. Just wanted to go back to the PYLARIFY guidance. I'm sorry if you said this and I missed it. So flat to low single digits for the full year. You had previously said flat first half '25 year-over-year for PYLARIFY. Is that still intact and just basically maybe a little less recovery in the back half (inaudible) or how should we think of any changes to cadence? Thank you.
你好。感謝您的跟進。只是想回到 PYLARIFY 指導。如果您說了這一點而我卻沒有註意到,我很抱歉。因此全年將持平至個位數低點。您之前曾說過,25 年上半年 PYLARIFY 的表現與去年同期持平。它是否仍然完好無損,只是後半部分的恢復可能稍微少一點(聽不清楚)或者我們應該如何考慮節奏的任何變化?謝謝。
Robert Marshall - Chief Financial Officer, Treasurer
Robert Marshall - Chief Financial Officer, Treasurer
Rich, that's actually fairly astute. I mean, the range does provide -- obviously, we delivered a flat, call it, first quarter. The math in and of itself, and you're right, the flat to low single digits is for the full year. So from a Q2 perspective, I would anticipate sequential growth over Q1. But it does sort of imply, I'm not going to again -- I do expect gross dose volume to grow, but I don't want to get into the pricing aspect of it. But what we're saying is that the back half would still have the potential to be mid-single-digit, in the back half. So the language and the overall sentiment remains largely the same as we get in here -- with the exception of maybe Q2 where we get into sort of the full effect of a year's worth of contracting.
里奇,這確實相當精明。我的意思是,該範圍確實提供了——顯然,我們交付了一個平台,稱之為第一季。從數學本身來看,您說得對,全年的成長率都是持平到個位數。因此從第二季的角度來看,我預計第二季將比第一季實現環比成長。但這確實暗示我不會再這樣做了——我確實預計總劑量會成長,但我不想涉及定價方面。但我們要說的是,後半段仍然有潛力達到中等個位數。因此,語言和整體情緒與我們目前的狀況基本保持不變——也許第二季度除外,在這一季度,我們將感受到一年的合約的全部影響。
Operator
Operator
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。