Lantheus Holdings, Inc. (LNTH) 2026 Q1 法說會逐字稿

Good morning. Welcome to Lantheus' First Quarter 2026 Conference Call. This call is being recorded, and a replay will 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. I'll now turn the call over to Mark Kinarney, Vice President of Investor Relations. Mark?

早安。歡迎參加 Lantheus 2026 年第一季財報電話會議。本次會議將被錄音，並將於會議結束後約兩小時在公司網站「投資人」專區提供重播，且至少保存 30 天。現在我把電話交給投資人關係副總裁 Mark Kinarney。Mark？

Thank you. Good morning. With me today are Mary Heino, our CEO and Executive Chairperson; Amanda Morgan, our Chief Commercial Officer; and Bob Marshall, our CFO. We will begin with prepared remarks and then take your questions.

謝謝。早安。今天與我一同出席的有：我們的執行長兼執行董事長 Mary Heino、首席商務長 Amanda Morgan，以及財務長 Bob Marshall。我們將先進行事先準備的發言，接著回答各位的提問。

This morning, we issued a press release, which was furnished to the SEC under Form 8-K reporting our first quarter 2026 results. The release and today's slide presentation are available on the Investors section of our website. Any comments 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.

今天早上，我們發布新聞稿，並以 8-K 表格提交給美國證券交易委員會（SEC），報告我們 2026 年第一季的業績。該新聞稿與今天的簡報投影片可於我們網站的「投資人」專區取得。任何評論可能包含前瞻性陳述。由於各種風險與不確定性，實際結果可能與這些陳述存在重大差異，相關內容已在我們向 SEC 提交的文件中詳述。討論亦將包含若干非 GAAP 財務衡量指標。

Reconciliation of these measures to the most directly comparable GAAP financial measures is included in the Investors section of our website. I will now turn the call over to Mary Anne.

這些指標與最直接可比的 GAAP 財務指標之調節表，已收錄於我們網站的「投資人」專區。現在我把電話交給 Mary Anne。

Thank you, Mark, and good morning, everyone. We had a strong start to the year with solid performance across PYLARIFY, NEURACEQ and DEFINITY. These results reflect our ongoing commitment to focus and discipline across the organization.

謝謝你，Mark，各位早安。我們今年開局強勁，PYLARIFY、NEURACEQ 與 DEFINITY 均展現穩健表現。這些成果反映我們在全組織持續秉持專注與紀律的承諾。

As we said last quarter, 2026 is a year of commercial execution and regulatory milestones. We're making deliberate choices about where we focus our commercial efforts and deploying capital so we're positioned to deliver solid results in 2026 and accelerate growth in 2027.

如同我們上季所說，2026 年是商業執行與法規里程碑的一年。我們正審慎決定商業資源的聚焦方向並配置資本，以確保在 2026 年交出穩健成果，並在 2027 年加速成長。

Our corporate focus is centered on radio diagnostics and our priorities for 2026 are clear.

我們的公司重點聚焦於放射性診斷，而 2026 年的優先事項也很明確。

First, maintain our market leadership in PSMA PET while preparing for a seamless transition to PYLARIFY TruVu, our newly approved PSMA PET formulation beginning in the fourth quarter.

第一，在維持我們於 PSMA PET 的市場領導地位之同時，為第四季起無縫轉換至新近獲批的 PSMA PET 配方 PYLARIFY TruVu 做好準備。

Second, continue to build momentum for NEURACEQ through deeper penetration within existing accounts, leveraging the breadth of the Lantheus portfolio to unlock incremental growth opportunities and expanding our manufacturing footprint, increasing supply availability.

第二，透過在既有客戶中更深度滲透，持續為 NEURACEQ 建立動能；運用 Lantheus 產品組合的廣度以釋放增量成長機會；並擴大我們的製造版圖、提升供應可用性。

Third, advance our late-stage clinical portfolio through key regulatory milestones and ensure launch readiness aligned with coding, coverage, payment, customer preparedness and market opportunity. And finally, allocate capital with discipline, prioritizing radio diagnostics while evaluating value-maximizing alternatives for our radiotherapeutic assets.

第三，推進我們後期臨床產品組合，達成關鍵法規里程碑，並確保上市準備就緒，涵蓋編碼、給付範圍（coverage）、支付（payment）、客戶準備度與市場機會的對齊。最後，以紀律配置資本，優先投入放射性診斷，同時評估可使放射性治療資產價值最大化的替代方案。

In addition to effective commercial execution, we advanced several key programs during the quarter that support our long-term growth strategy. On March 6, the FDA approved PYLARIFY TruVu, our new PSMA PET imaging agent. PYLARIFY TruVu offers the same proven diagnostic properties as PYLARIFY with a similar safety and efficacy profile.

除有效的商業執行外，我們在本季也推進了多項支持長期成長策略的關鍵計畫。3 月 6 日，FDA 核准 PYLARIFY TruVu（我們新的 PSMA PET 影像顯影劑）。PYLARIFY TruVu 具備與 PYLARIFY 相同、經驗證的診斷特性，且安全性與有效性概況相近。

The value add of this product will be the larger batch sizes that can be enabled at manufacturing sites with high energy cycle times. This creates the potential to serve more patients and support a broader geographic reach.

此產品的附加價值在於：在具備高能量循環時間（high energy cycle times）的製造據點可實現更大的批次產量。這將有機會服務更多病患，並支持更廣泛的地理覆蓋。

We estimate that more than 70% of PYLARIFY supply today is produced at PMF sites equipped with high energy cycle times, giving us confidence that through our broad PMS network, we are well positioned to optimize the benefit that PYLARIFY TruVu can provide.

我們估計，目前超過 70% 的 PYLARIFY 供應量是在配備高能量循環時間的 PMF 據點生產，這讓我們有信心，透過我們廣泛的 PMS 網路，我們已具備良好條件以最佳化 PYLARIFY TruVu 所能帶來的效益。

We also announced during the quarter, the FDA extended the PDUFA date for Actinium by three months to June 29, 2026, to allow additional time to review manufacturing-related information. Similar to our efforts with PYLARIFY TruVu, we remain focused on advancing launch readiness, including securing coding, coverage payment and customer preparedness through the second half of 2026 with the objective of a full commercial launch in early 2027.

我們也在本季宣布，FDA 將 Actinium 的 PDUFA 日期延後三個月至 2026 年 6 月 29 日，以便有更多時間審查與製造相關的資訊。與我們推進 PYLARIFY TruVu 的工作類似，我們仍專注於推動上市準備，包括在 2026 年下半年完成編碼、給付範圍與支付，以及客戶準備度，目標是在 2027 年初全面商業上市。

On March 2, we announced that the FDA had offered tentative approval for PNT2003, the first radio equivalent to Lutathera for the treatment of gastro entero pancreatic neuroendocrine tumors or Gep/NET. Tentative approval confirms that the FDA has completed its substantive review and that our application meets the requirements for approval.

3 月 2 日，我們宣布 FDA 已對 PNT2003 提供暫定核准（tentative approval）。PNT2003 是首個與 Lutathera 等效的放射性藥物，用於治療胃腸胰神經內分泌腫瘤（gastro entero pancreatic neuroendocrine tumors，或 Gep/NET）。暫定核准確認 FDA 已完成實質審查，且我們的申請符合核准要求。

The timing of our launch will consider the following factors; timing of final FDA approval, the expiration of the 30-month Hatch-Waxman stay and disposition of the related legal proceedings as well as manufacturing and commercial strategy to ensure launch success.

我們的上市時程將考量以下因素：FDA 最終核准的時間、30 個月 Hatch-Waxman 暫緩期（stay）的到期時間及相關法律程序的處置結果，以及製造與商業策略，以確保上市成功。

As outlined last quarter, our strategy and related investments are centered on radio diagnostics and the progress we made this quarter reflects that focus. We are selectively prioritizing first and best-in-class PET radio diagnostic assets that complement our existing commercial portfolio and align closely with our nuclear medicine customer base.

如同上季所述，我們的策略與相關投資以放射性診斷為核心，而本季的進展也反映了這一聚焦方向。我們正選擇性地優先投入同級最佳（best-in-class）的 PET 放射性診斷資產，以補強既有商業產品組合，並與我們的核醫客戶基礎高度契合。

I will highlight a few key pipeline updates. MK-6240, our registrational stage tau-targeted PET radio diagnostic for Alzheimer's disease represents an important asset within our Pharma Solutions portfolio and is the leading imaging agent supporting late-stage Alzheimer's disease-modifying therapy or DMT development.

我將重點說明幾項管線更新。MK-6240 是我們用於阿茲海默症、處於註冊申請階段（registrational stage）的 tau 標的 PET 放射性診斷資產，屬於我們 Pharma Solutions 產品組合中的重要資產，也是支持後期阿茲海默症疾病修飾療法（disease-modifying therapy，DMT）開發的領先影像顯影劑。

It is currently the most widely used imaging agent in beta amyloid and tau-targeted therapeutic candidate clinical programs. MK-6240 serves as an imaging agent for treatment eligibility in 17 current pharma-sponsored AD therapeutic programs and has a PDUFA date of August 13 of this year.

目前它是在 β 類澱粉蛋白（beta amyloid）與 tau 標的治療候選藥物臨床計畫中使用最廣泛的影像顯影劑。MK-6240 在 17 項目前由藥廠贊助的阿茲海默症治療計畫中用於治療適格性（treatment eligibility）影像判定，且其 PDUFA 日期為今年 8 月 13 日。

Lantheus 2401, our gastrin-releasing peptide receptor or GRPR targeted PET radio diagnostic for prostate cancer is advancing towards its planned registrational program this year. GRPR is a differentiated target from PSMA and Lantheus 2401 has the potential to complement PSMA PET imaging by identifying disease in patients who may be PSMA negative or equivocal, extending this addressable prostate cancer population while fitting naturally within our existing prostate cancer franchise.

Lantheus 2401 是我們針對前列腺癌、以胃泌素釋放胜肽受體（gastrin-releasing peptide receptor，GRPR）為標的的 PET 放射性診斷資產，正朝今年規劃的註冊性計畫推進。GRPR 與 PSMA 為差異化標的；Lantheus 2401 有潛力透過辨識可能為 PSMA 陰性或結果不明確（equivocal）的病患之疾病狀態，來補充 PSMA PET 影像，進一步擴大可觸及的前列腺癌族群，同時也能自然融入我們既有的前列腺癌產品線。

Across the pipeline, we remain disciplined in strategically deploying investments based on stage gate and long-term opportunity. With robust mid- and long-term revenue drivers, a promising late-stage pipeline and a clear strategic road map, we are confident in our ability to drive meaningful performance gains that support a compelling outlook for our shareholders, and we're executing against that plan.

在整體管線方面，我們仍以紀律為原則，依據階段性關卡（stage gate）與長期機會來策略性部署投資。憑藉強勁的中長期營收驅動因素、具前景的後期管線，以及清晰的策略路線圖，我們對於推動具意義的績效提升、以支持股東具吸引力的前景充滿信心，並正依計畫執行。

Our strong first quarter results reinforce that 2026 will be a year of commercial execution and regulatory progress, laying the groundwork for growth acceleration beginning in 2027. I also want to provide a brief update on our CEO search. The Board's process is progressing well, and we have narrowed the search to a small number of highly qualified candidates.

我們第一季的強勁成果再次印證，2026 年將是商業執行與法規進展的一年，為自 2027 年起的成長加速奠定基礎。我也想就我們的執行長遴選提供簡要更新。董事會的流程進展順利，我們已將搜尋範圍縮小至少數幾位高度合格的候選人。

In the meantime, our leadership team and I remain fully focused on execution as the first quarter results fully demonstrate. I will now hand the call over to Amanda to provide additional detail on commercial performance across our oncology, neurology and cardiology assets.

在此期間，我與領導團隊仍全力專注於執行，而第一季的成果已充分證明這點。現在我把電話交給 Amanda，請她就我們腫瘤、神經與心臟科資產的商業表現提供更多細節。

Thank you, Mary Heino. First quarter performance demonstrated continued commercial execution across our portfolio with solid volume growth and disciplined performance across each of our three core products. PYLARIFY, our market-leading PSMA PET imaging agent, delivered a solid quarter with U.S. volume increasing approximately 5.8% year-over-year. Performance was driven by consistent demand across our established customer base and continued pricing discipline in a highly competitive environment.

謝謝你，Mary Heino。第一季表現顯示我們在整體產品組合上持續落實商業執行，量能穩健成長，且在三項核心產品上皆維持紀律性的表現。PYLARIFY 作為市場領先的 PSMA PET 影像顯影劑，本季表現穩健，美國使用量年增約 5.8%。此表現主要來自既有客戶基礎的穩定需求，以及在高度競爭環境下持續維持定價紀律。

Net ASP and volume for PYLARIFY remained stable sequentially despite ongoing competitive activity, we are well positioned as we continue to execute on our portfolio-based strategy.

儘管競爭活動持續，PYLARIFY 的淨 ASP（平均銷售價格）與使用量相較前一季仍保持穩定；在我們持續執行以產品組合為基礎的策略之際，我們具備良好定位。

This evolution strengthens our presence across sites of care and our PMF network and reinforces our market leadership in PSMA PET. Together, these factors support a seamless transition to PYLARIFY TruVu, accelerate Neuraceq growth and prepare the organization for future launch opportunities.

這一演進強化了我們在各照護場域（sites of care）與 PMF 網路的布局，並鞏固我們在 PSMA PET 的市場領導地位。綜合而言，這些因素支持我們順利轉換至 PYLARIFY TruVu、加速 Neuraceq 成長，並讓組織為未來的上市機會做好準備。

Overall, PYLARIFY remains a core contributor to our radio diagnostic strategy, supported by disciplined execution, deep customer relationships and continued usage and expansion of PSMA PET. The FDA approval of PYLARIFY TruVu marks the next chapter of our flagship PSMA PET portfolio and reinforces our ability to serve the market reliably and at scale.

整體而言，PYLARIFY 仍是我們放射性診斷策略的核心貢獻者，並由紀律性執行、深厚的客戶關係，以及 PSMA PET 的持續使用與擴張所支撐。PYLARIFY TruVu 的 FDA 核准揭開我們旗艦 PSMA PET 產品組合的新篇章，也再次證明我們能以可靠且可規模化的方式服務市場。

With approval secured, we are now executing against our transition plan with meaningful revenue contribution expected in 2027. We have submitted our application for a HIC6 code and are preparing to apply for transitional pass-through status.

在取得核准後，我們正依轉換計畫推進，預期在 2027 年帶來具意義的營收貢獻。我們已提交 HIC6 代碼申請，並正準備申請過渡性 pass-through 身分。

In parallel, we are working closely with our PMF partners to secure necessary FDA approvals for each manufacturing site ahead of the planned conversion, targeted to begin in the fourth quarter of this year. Our approach is deliberate. We will initiate conversions only once reimbursement coding is in place and customers and payer systems are ready to submit and process claims.

同時，我們正與 PMF 合作夥伴密切合作，為每一個製造據點在計畫轉換前取得必要的 FDA 核准，目標是在今年第四季開始轉換。我們的做法審慎：只有在報銷編碼到位，且客戶與付款方系統已準備好提交並處理理賠申請後，我們才會啟動轉換。

Our PMF partners are preparing to transition to the new formulation and recognize the operational advantages that PYLARIFY TruVu offers, including enhanced stability at higher radioactive concentrations, which provides greater supply flexibility. This creates the potential to serve more patients within a given market or support delivery to sites that are further from the manufacturing location or potentially both, depending on demand in a particular area.

我們的 PMF 合作夥伴正準備轉換至新配方，並認同 PYLARIFY TruVu 所帶來的營運優勢，包括在較高放射性濃度下具更佳穩定性，從而提供更大的供應彈性。這使得在特定市場中有機會服務更多病患，或支持配送至距離製造地點更遠的據點，或兩者兼具，取決於特定區域的需求。

Now turning to the rest of our commercial portfolio. Neuraceq, our beta amyloid PET imaging agent for Alzheimer's disease, generated $35.4 million in the first quarter revenue, representing 14.3% growth compared to the fourth quarter of 2025.

現在轉到我們其餘的商業產品組合。Neuraceq 是我們用於阿茲海默症的 β 類澱粉蛋白 PET 影像顯影劑，第一季營收為 3,540 萬美元，較 2025 年第四季成長 14.3%。

As the second most utilized and fastest-growing beta amyloid PET imaging agent in the U.S., Neuraceq addresses a large and expanding market opportunity. Growth was driven by increased utilization within existing accounts, supported by broader adoption of Alzheimer's, DMTs and clinical guidelines that favor earlier diagnostic use, particularly in patients with mild cognitive impairment and early Alzheimer's disease.

作為美國使用量第二高且成長最快的 β 類澱粉蛋白 PET 影像顯影劑，Neuraceq 對應一個龐大且持續擴張的市場機會。成長主要來自既有客戶帳戶內使用量提升，並受惠於阿茲海默症疾病修飾療法（DMTs）的更廣泛採用，以及偏向更早期診斷使用的臨床指引，特別是在輕度認知障礙與早期阿茲海默症患者中。

We are leveraging our existing nuclear medicine relationships across the Lantheus portfolio, supported by continued expansion of our Neuraceq PMS footprint, which is now up to 22 sites to drive execution and incremental growth as additional locations come online.

我們正運用 Lantheus 產品組合中既有的核醫關係網絡，並在持續擴大 Neuraceq 的 PMS 佈局支持下推動執行與增量成長；目前已擴展至 22 個據點，隨著更多地點上線，將帶動落地與額外成長。

Together, these factors further build on the momentum exiting 2025 and reinforce our confidence in Neuraceq's long-term growth potential. DEFINITY, our market-leading ultrasound-enhancing agent, remained a steady contributor to our overall performance and delivered $84.6 million in first quarter revenue, representing year-over-year growth of approximately 6.8%. Growth was primarily driven by increased volume demand.

綜合而言，這些因素進一步延續 2025 年底的動能，並強化我們對 Neuraceq 長期成長潛力的信心。DEFINITY 作為我們市場領先的超音波增強顯影劑，仍是整體表現的穩定貢獻者，第一季營收為 8,460 萬美元，年增約 6.8%。成長主要由需求量增加所帶動。

With more than 80% market share, DEFINITY continues to demonstrate the durability of a long-standing market preferred product supported by deeply embedded clinical workflows and consistent utilization across sites of care over its 25-year history.

在超過 80% 的市占率下，DEFINITY 持續展現其作為長期市場首選產品的韌性；其背後有深度嵌入的臨床工作流程支撐，並在 25 年歷史中於各照護場域維持一致的使用量。

I'll now turn the call over to Bob to provide more detail on our first quarter results.

接下來我把電話交給 Bob，請他更詳細說明我們第一季的業績。

Thank you, Amanda, and good morning, everyone. I will provide highlights of the first quarter 2026 financials, focusing on adjusted results with comparisons to the prior year quarter, unless otherwise noted. Revenue for the first quarter was $377.3 million, an increase of 1.2% compared to the prior year and increased 8.6% when adjusted to exclude $25.2 million of spec revenues from the same period prior year, which was divested on January 1.

謝謝你，Amanda，各位早安。我將提供 2026 年第一季財務重點，除非另有說明，將以調整後結果為主並與去年同期比較。第一季營收為 3.773 億美元，較去年同期增加 1.2%；若調整排除去年同期 2,520 萬美元的 spec 營收（該業務已於 1 月 1 日剝離），則營收增加 8.6%。

Before I begin with the details, I would like to note that we have reconfigured our revenue reporting into new categories to reflect the diversity of our portfolio. The four main groupings include oncology, neurology, cardiology and strategic partnerships and other as well as one additional for the divested spec business to reflect prior period results. Our SEC filings reflect this change, and we have grouped prior period comparisons accordingly.

在我開始說明細節之前，我想先指出，我們已將營收揭露重新配置為新的分類，以反映我們產品組合的多元性。四個主要分類包括腫瘤、神經、心臟，以及策略合作與其他；另增設一個已剝離的 spec 業務分類，用以呈現前期期間的結果。我們的 SEC 申報文件已反映此變更，且我們也相應地對前期比較進行分組。

Now starting with oncology. Consisting of PYLARIFY, it contributed $240.9 million of revenue, down 6.5% from the prior year. Neurology revenue, consisting of Neuraceq was $35.4 million for the quarter. Cardiology revenue consisting of DEFINITY was $84.6 million, up 6.8% year-over-year. Strategic partnerships and other revenue was $16.3 million, up 52.1% due to the strength of our Pharma Solutions portfolio in addition to adding the Evergreen CDMO business.

先從腫瘤業務開始。該分類由 PYLARIFY 構成，貢獻營收 2.409 億美元，較去年同期下降 6.5%。神經業務營收（由 Neuraceq 構成）本季為 3,540 萬美元。心臟業務營收（由 DEFINITY 構成）為 8,460 萬美元，年增 6.8%。策略合作與其他營收為 1,630 萬美元，年增 52.1%，主要受惠於我們 Pharma Solutions 產品組合的強勁表現，並新增 Evergreen CDMO 業務。

MK-6240 represented over half of the revenue in this category.

MK-6240 佔此分類營收的一半以上。

Gross profit margin for the quarter was 67.0%, flat to first quarter 2025, favorably impacted by the SC divestiture, PYLARIFY and DEFINITY volumes as well as DEFINITY price. offset by a decrease in PYLARIFY net price and inclusion of the Evergreen manufacturing facility and a near-term margin dilution of Neuraceq relative to the company average, both of which were not in the comparative period.

本季毛利率為 67.0%，與 2025 年第一季持平；受 SC 剝離、PYLARIFY 與 DEFINITY 的銷量，以及 DEFINITY 價格的正面影響，但被 PYLARIFY 淨售價下降、納入 Evergreen 製造設施，以及 Neuraceq 相較公司平均的短期毛利稀釋所抵銷；後兩者在比較期間並不存在。

Operating expenses at 32.8% of net revenue were 455 basis points unfavorable from the prior period, but favorable to previously guided spending levels. This increase was mainly due to the acquisitions of Evergreen and LMI operations across each spending category, which are not reflected in the prior period.

營業費用占淨營收 32.8%，較前期不利 455 個基點，但優於先前指引的支出水準。此增加主要來自 Evergreen 與 LMI 營運的收購，且其影響在前期期間未反映。

Increases in research and development expense, which was due largely to planned investments to advance our expanded clinical stage portfolio. Sales and marketing increases reflect the inclusion of the Neuraceq sales team and launch activities, mainly focused on PYLARIFY TruVu. G&A was up slightly in the period due to higher professional fees and employee-related costs in the quarter. Operating profit for the quarter was $129.1 million, a decrease of 10.5%. Other income and expense was $0.8 million of expense.

研發費用增加，主要是因為依計畫投入資源以推進我們擴大的臨床階段產品組合。銷售與行銷費用增加，反映納入 Neuraceq 銷售團隊與上市推廣活動，主要聚焦於 PYLARIFY TruVu。一般與行政費用在本期小幅上升，係因本季專業服務費與員工相關成本較高。本季營業利益為 1.291 億美元，下降 10.5%。其他收益與費用為 80 萬美元費用。

Total adjustments in the quarter were $28.1 million of net adjustments before taxes. The company recorded a gain on the sale of SPC of $59.3 million and unrecognized gain of $16.6 million attributed to its equity investment in Perspective Therapeutics, offset by an unrecognized loss of $1.7 million on Radio pharm Theragnostic.

本季調整項目合計為稅前淨調整 2,810 萬美元。公司認列出售 SPC 的處分利益 5,930 萬美元，並就其對 Perspective Therapeutics 的股權投資認列未實現利益 1,660 萬美元；同時就 Radio pharm Theragnostic 認列未實現損失 170 萬美元予以抵銷。

Also offsetting these gains, the company incurred $16.0 million and $16.7 million of expense associated with noncash stock and incentive plans and acquired intangible amortization, respectively. The company recorded $6.4 million of other acquisition, integration and divestiture costs. The remaining $7 million is related to other nonrecurring expenses.

此外，為抵銷上述利益，公司分別認列與非現金股票與激勵計畫相關費用 1,600 萬美元，以及取得之無形資產攤銷費用 1,670 萬美元。公司另認列 640 萬美元的其他收購、整合與剝離成本。其餘 700 萬美元與其他非經常性費用相關。

Our effective tax rate was 25.3% in the quarter. The resulting reported net income for the quarter was $118.4 million and a profit of $95.8 million on an adjusted basis, a decrease of 12.5% from the prior year period. GAAP fully diluted earnings per share for the first quarter was $1.80 and $1.46 on an adjusted basis, a decrease of 4.6%.

本季有效稅率為 25.3%。因此，本季報告淨利為 1.184 億美元；調整後基礎的淨利為 9,580 萬美元，較去年同期下降 12.5%。第一季 GAAP 完全稀釋每股盈餘為 1.80 美元，調整後為 1.46 美元，下降 4.6%。

Now turning to cash flow. First quarter operating cash flow totaled $125.1 million as compared to $107.6 million in the prior year quarter. Capital expenditures totaled $3.2 million, $5.5 million less than the prior year quarter. Free cash flow, which we define as operating cash flow less capital expenditures, was $121.9 million, an increase of $23.1 million from the prior year period. Taken together, cash and cash equivalents net of restricted cash were $498.6 million as of the end of Q1.

接著看現金流。第一季營運現金流合計 1.251 億美元，去年同期為 1.076 億美元。資本支出合計 320 萬美元，較去年同期少 550 萬美元。自由現金流（我們定義為營運現金流減資本支出）為 1.219 億美元，較去年同期增加 2,310 萬美元。綜合而言，截至第一季末，扣除受限制現金後的現金及約當現金為 4.986 億美元。

We have $200 million remaining on our Board authorized buyback program and have access to our $750 million undrawn bank revolver.

我們在董事會核准的庫藏股回購計畫下尚餘 2 億美元額度，並可動用 7.5 億美元尚未提用的銀行循環信用額度。

Now turning to expectations for full year '26. The strong start to the year across the portfolio reinforces our confidence to deliver on the outstanding guidance for both revenue and adjusted EPS. We remain steadfast in our strategies to protect the long-term value of our PSMA franchise, especially ahead of launching PYLARIFY and TruVu beginning later this year and also remain ever mindful of potential competitive dynamics. As such, our full year forecasted revenue remains at $1.4 billion to $1.45 billion for 2026.

接著談 2026 全年展望。產品組合在年初的強勁開局，強化我們對達成既有營收與調整後 EPS 指引的信心。我們仍堅定執行策略以維護 PSMA 特許經營的長期價值，特別是在今年稍晚開始推出 PYLARIFY TruVu 之前，同時也持續關注潛在的競爭態勢。因此，我們對 2026 年全年預估營收仍維持在 14 億至 14.5 億美元。

Our first quarter results underscore the disciplined execution of our strategic priorities and commitment to streamlining our cost structure to drive operational efficiencies, enabling us to support sustainable long-term value creation.

我們第一季的結果凸顯了對策略優先事項的紀律性執行，以及我們致力於精簡成本結構以提升營運效率，從而支持可持續的長期價值創造。

We are making progress to evaluate alternative opportunities for the therapeutic assets to rebase the company's earnings profile and growth trajectory as was noted on last earnings call. We continue to balance strategic investments and cost management across the organization and expect to deliver solid bottom line results with EPS in a range of $5 to $5.25.

正如上次法說會所提及，我們在評估治療性資產的替代機會方面持續取得進展，以重塑公司的獲利結構與成長軌跡。我們持續在全公司範圍內平衡策略性投資與成本管理，並預期可交付穩健的獲利表現，EPS 目標區間為 5.00 至 5.25 美元。

With that, let me turn the call back to Mary Anne.

接下來，我把電話交回給 Mary Anne。

Thank you, Bob. In the first quarter, we accomplished what we set out to do. PYLARIFY, Neuraceq and DEFINITY all performed well, and we achieved two important regulatory milestones with the FDA approval of PYLARIFY TruVu and tentative approval of PNT2003.

謝謝你，Bob。第一季我們完成了原先設定的目標。PYLARIFY、Neuraceq 與 DEFINITY 表現都很出色，且我們在監管方面達成兩項重要里程碑：FDA 核准 PYLARIFY TruVu，以及 PNT2003 的暫定核准。

Looking ahead, our priorities are unchanged; maintain our market leadership in PSMA PET by sustaining PYLARIFY volume growth and executing a seamless transition to PYLARIFY TruVu, continue to build momentum for Neuraceq and successfully advance our registrational stage products towards regulatory milestones. All of these will position Lantheus for the growth acceleration we expect beginning in 2027.

展望未來，我們的優先事項不變：透過維持 PYLARIFY 銷量成長並順利完成向 PYLARIFY TruVu 的無縫轉換，來維持我們在 PSMA PET 的市場領導地位；持續為 Neuraceq 建立動能；並成功推進我們處於註冊性階段的產品，朝向監管里程碑前進。這些都將使 Lantheus 站上我們預期自 2027 年開始的成長加速軌道。

We are driving forward through the rest of 2026 with confidence in our strategy and in the Lantheus' team's ability to deliver. The first quarter was a terrific start, and we remain focused on the work ahead.

我們將帶著對策略的信心，以及對 Lantheus 團隊交付能力的信心，持續推進 2026 年剩餘時間。第一季是非常好的開局，我們仍專注於接下來的工作。

With that, I'll turn it over to Q&A. Operator?

接下來，我們進入問答環節。接線員？

(Operator Instructions)

（接線員指示）

Anthony Petrone, Mizuho Financial Group.

Anthony Petrone，瑞穗金融集團。

One moment for our next -- Anthony. Anthony?

請稍候，我們下一位——Anthony。Anthony？

Richard Newitter, Truist.

Richard Newitter，Truist。

Hi, thanks for taking the questions, and congrats on the progress this quarter.

嗨，謝謝讓我提問，也恭喜你們本季的進展。

I've got -- I guess the first one, maybe for Bob on guidance. You had a pretty nice beat in the first quarter across the board, just about every product line. I guess the reiteration of the guide assumes some step down in the 2Q to 4Q, presumably for all the businesses. I'm assuming that's just conservatism on your part. I just wanted to make sure, one, that's the case.

我有——我想第一個問題可能是問 Bob，關於財測指引。你們第一季幾乎在各個面向都表現得很不錯，幾乎每一條產品線都優於預期。我想你們重申指引，等於假設第二季到第四季會有一些下滑，推測是所有業務都會如此。我猜這只是你們比較保守。我只是想確認一下，第一，是否確實如此。

And then was there anything -- is there anything you're seeing that would lead you to be incrementally cautious as we move forward into the remainder of the year? Or is this just good old-fashioned prudence on your part, you still have a few more quarters of transitional pass-through disadvantage to get through? And then also, if you could just comment on what your assumption is for PSMA PET imaging diagnostics market growth in 2026 for the remainder of the year? And what did it grow in the first quarter?

另外，有沒有任何——你們是否看到任何跡象，會讓你們在接下來進入今年剩餘期間時變得更為謹慎？還是這只是你們一貫的審慎作風，畢竟你們還有幾個季度要度過過渡性轉付（pass-through）不利因素？另外，也請你們評論一下，你們對 2026 年 PSMA PET 影像診斷市場在今年剩餘期間的成長假設是什麼？以及第一季成長了多少？

Okay. So I'll start with the -- obviously, with the guidance. So to your point, we had a very solid start. And we saw that in terms of volume growth, in terms of pricing dynamics, fairly steady state from what we've seen over the last number of quarters, in fact, almost delivering exactly the same number for each of the last three quarters in a row. But it's early in the year.

好的。我先從——顯然，先談指引。就如你所說，我們開局非常扎實。我們在量的成長、以及定價動態上都看到了這點；整體相當穩定，與過去幾個季度所見幾乎一致，事實上，連續三個季度幾乎都交出完全相同的數字。但現在還在年初。

And so we're going to remain vigilant to the market, the competitive environment out there. We still have one competitor who is maybe find some footing with their new products, launch themselves as well as one that will be losing pass-through later this year, call it, October 1. So for us, we're going to -- to your point, we're going to be prudent with this.

因此我們會持續密切關注市場與外部競爭環境。我們仍有一位競爭對手可能正逐步站穩腳步、推出他們的新產品；另外也有一家將在今年稍晚失去轉付（pass-through），大約是 10 月 1 日。對我們而言——如你所說——我們會在這方面保持審慎。

The other thing that I think that plays into this a little bit is the fact that, as Mary Anne noted in her prepared remarks, that we do see a new CEO in the near future. And I think it's right to allow that person to own the balance of the year. So our assumptions really haven't changed in terms of expecting what we had said earlier in terms of gross to net as the year progresses. And I still continue to model modest volume growth looking forward. So I wouldn't have you model Q1 forward in that sense.

另外一點我認為也會影響到這件事的是，正如 Mary Anne 在事先準備的發言中提到的，我們在不久的將來會迎來一位新 CEO。我認為讓那位人選來掌握今年剩餘期間是合理的。因此，我們的假設其實沒有改變：就如我們先前所說，隨著年度推進，毛額到淨額（gross-to-net）的走勢仍按原先預期。我也仍然以溫和的量成長作為未來模型假設。所以在這個意義上，我不會建議你把第一季的表現直接往後外推。

So our strategy remains the same. It's intact. We're watching our competitors and talking with our customers, remaining disciplined. And again, the focus for the year is on launching PYLARIFY TruVu and protecting that franchise on a going-forward basis.

所以我們的策略不變，也仍然完整。我們持續觀察競爭對手、與客戶溝通，並保持紀律。再者，今年的重點是推出 PYLARIFY TruVu，並在未來持續保護這個產品線（franchise）。

It's Maryann, and I'll step in on your second question around the PSMA PET market growth. I think the market continues to play out exactly as we anticipated. If we look back and look back to '25, we saw high teens to low 20s percent growth for the entire market over the course of the year prior -- relative to the prior year. And this year, as we -- I think we shared in our last quarter's discussion points, we were backing off and saying that we expected for '26, that growth would be in the low teens. And I think that is what we're seeing.

我是 Maryann，我來補充你第二個問題，關於 PSMA PET 市場成長。我認為市場的發展完全如我們所預期。回頭看 2025 年，整體市場全年相較前一年成長約高十幾到低二十幾個百分點。今年，正如我們在上季討論重點中分享的，我們已經下修並表示對 2026 年的預期是成長落在低十幾個百分點。我認為我們目前看到的就是這樣。

I'm not being specific because this is a market that from a data perspective, truly has to be triangulated. Unlike the pharmaceutical prescription market, there are no clean third-party data sources to kind of bring these estimates together.

我沒有給出非常精確的數字，因為這個市場在資料面上確實需要用多方資訊交叉驗證（triangulated）。不像藥品處方市場，有乾淨的第三方資料來源可以把這些估算整合起來。

So what we do is we look at our own results We, of course, monitor what our competitors are reporting. However, as you can imagine, there's not a lot of talk track from Novartis on locomotes and PostLuma is offered by a private company. So I'm offering you that just to say, I'm not trying to avoid giving you a direct numeric answer, but it is a triangulated figure that we arrive at, and we're very pleased with what we're seeing in the market.

所以我們會看我們自己的結果，當然也會追蹤競爭對手的揭露。不過你也能想像，Novartis 對 Locametz 的說法不多，而 Posluma 又是由一家私人公司提供。因此我補充這些只是想說，我不是刻意迴避給你一個直接的數字答案；但這確實是我們透過交叉驗證得出的估計值，而我們對目前市場看到的情況非常滿意。

Anthony Petrone, Mizuho Financial Group.

Mizuho Financial Group 的 Anthony Petrone。

Sorry about that. I was muted, hopping across calls here, but congrats on the strong start to the year. Maybe just on TruVu into the TPT ruling and just launch, how that's going to sort of work out from a contracting perspective? When do you think TruVu will be completely adopted? And at what point does PYLARIFY Gen 1 get phased out?

抱歉，剛剛我被靜音了，在不同電話會議之間切換。不過恭喜你們今年開局強勁。想請教 TruVu、TPT 裁定以及上市推進方面，從合約簽訂（contracting）的角度會如何運作？你們認為 TruVu 何時會被完全採用？以及 PYLARIFY 第一代會在什麼時點被淘汰？

That will be my question. I'll hop back in queue.

這就是我的問題。我會回到排隊序列。

Terrific. Anthony, thanks for the question. I'll take that. First, let me offer for clarity. It's not a -- PYLARIFY won't be phased out.

很好。Anthony，謝謝你的問題。我來回答。首先我先澄清一下：這不是——PYLARIFY 不會被淘汰。

PYLARIFY will be transitioned directly to PYLARIFY TruVu. So in any market, only one of the products will be available at a time. And that's very purposeful on our part because as you can imagine, if our PMF partners had to run two different batches, which they would have to, it would take up too much of their manufacturing time, and we prefer to have a single product in each market that we can focus on. So just I wanted to offer that for clarity. It will be geographically a site-by-site conversion.

PYLARIFY 會直接轉換到 PYLARIFY TruVu。因此在任何市場，同一時間只會有其中一個產品可供使用。這是我們刻意為之，因為如你所想，如果我們的 PMF 合作夥伴必須跑兩種不同批次——他們確實得這麼做——會占用太多製造時間；我們更希望每個市場只有單一產品，讓我們能集中資源。因此我想先把這點說清楚。這將會以地理區域、逐站點（site-by-site）的方式完成轉換。

As we've offered before, I'll share again that we plan to begin that conversion in Q4 of this year. It's very carefully thought out, and I'll explain why. These products as a class, PET diagnostic products are uniformly prior authorized. You require prior authorization for insurance to cover them. We must ensure that insurance coverage is in place and that the systems are fully operational with the coding and the coverage requirements for TruVu before we take that product into any market.

如同我們之前提過的，我再分享一次：我們計畫在今年第四季開始這個轉換。這是經過非常周密的規劃，我也解釋原因。這一類產品——PET 診斷產品——基本上都需要事前授權（prior authorization）。你需要事前授權，保險才會給付。我們必須確保 TruVu 的保險給付已到位，且在我們把產品導入任何市場之前，編碼與給付要求相關的系統都已完全運作。

In like fashion, and you're aware of this from the comments we've offered, we also have to make sure that we have our HCPCS code and that we have PPT in place, transitional pass-through payment. Those have slightly different schedules of what the application process is for applying and receiving it.

同樣地，你也從我們先前的評論中知道，我們也必須確保 HCPCS 代碼到位，並且具備 PPT，也就是過渡性轉付支付（transitional pass-through payment）。這些在申請與取得的流程時程上略有不同。

But from our perspective, the one piece that's clear is all must be in place before we ask our customers to start ordering TruVu. -- we have worked long and hard to make sure that this will be a seamless transition, and we're really confident in it. But that's why you've seen already we got the approval date, but we're not yet in the market. This is carefully thought through and will be exceptionally executed once we take it into the market.

但就我們而言，有一點很清楚：在我們請客戶開始訂購 TruVu 之前，所有條件都必須到位。——我們已經投入很長時間、非常努力，確保這會是一個無縫轉換，我們也非常有信心。但這就是為什麼你已經看到我們拿到核准日期，卻尚未進入市場。這是經過審慎規劃的，一旦導入市場，將會以極高水準執行。

Thank you.

謝謝。

Ruana Ruiz, Leerink Partners.

Leerink Partners 的 Ruana Ruiz。

Hey, morning, everyone. I have a follow-up question about TruVu. I was curious what strategies do you plan to use in terms of enabling customer readiness and prepping hospitals and imaging sites to potentially switch and get really comfortable with TruVu? And I was also curious, given what you've learned from the original PYLARIFY launch, is there anything you want to get ahead of and proactively mitigate in terms of possible hurdles to adoption?

嗨，各位早安。我有一個關於 TruVu 的追問。我想了解你們計畫採取哪些策略來提升客戶就緒度，並協助醫院與影像中心做好準備，以便可能切換並真正熟悉 TruVu？另外，基於你們從最初 PYLARIFY 上市學到的經驗，有沒有什麼你們想提前著手、主動降低採用障礙的地方？

So Ron, I'll take your question as well, and I'll kind of bounce up of what I just shared from Anthony's question. This is a master piece of preparation because before the first dose and from our customers' perspective, all we want them to see is that their dose shows up and that the coverage and payment, the reimbursement for it has already been fully approved. And so we want it to look invisible to them as to which of the Lantheus PET franchise products they're using, TruVu or PYLARIFY. And again, they'll only be using one at a time. There's lots we can do to get ready.

Ron，我也來回答你的問題，並延伸我剛剛對 Anthony 問題的說明。這是一個準備工作的「大工程」，因為在第一劑（dose）之前，從客戶角度來看，我們希望他們看到的只有：他們需要的劑量準時送達，而且其保險涵蓋與付款、也就是報銷（reimbursement），都已經完全核准。因此我們希望對他們而言，使用的是 TruVu 還是 PYLARIFY——也就是 Lantheus PET 產品線中的哪一個——看起來是「無感」的。再強調一次，他們同一時間只會使用其中一個。我們可以做很多準備工作來達成這點。

And you heard Amanda and Amanda's comments her repeatedly referring to our prostate cancer franchise. It is actually in the nuclear medicine customer base, it's actually more than that. We are a full portfolio of products that we bring them in addition to our prostate cancer PET products. And all of our communications with our customers really center on one thing. Do you have the access you need?

你也聽到 Amanda——以及 Amanda 的評論——她反覆提到我們的前列腺癌產品線。其實在核醫客戶群中，這不只如此。我們提供的是完整的產品組合，除了前列腺癌 PET 產品之外，還有其他產品一併提供。我們與客戶的所有溝通，核心都圍繞一件事：你是否擁有你所需要的可近性（access）？

Does the product show up when you need it? And do you get fair reimbursement and coverage for it? And that is what we work continuously to ensure for our patients. We also will have some work done in order to contractually prepare our customers for TruVu versus PYLARIFY. And that is also something that we're very experienced with.

你需要時產品是否能送達？以及你是否能獲得合理的報銷與保險涵蓋？這些就是我們持續努力、為病患確保的事情。我們也會進行一些工作，從合約面協助客戶為 TruVu 相對於 PYLARIFY 做好準備，而這也是我們非常有經驗的領域。

From a nuclear medicine perspective, we have been doing this for 60-plus years with the nuclear medicine department. So we're also confident that we'll be able to handle that.

從核醫的角度來看，我們與核醫部門合作已經超過 60 年。因此我們也有信心能把這件事處理好。

I will say just operationally, there is a set of functional steps that we'll go through with each PMS to ensure that they are -- that they can manufacture and that they're approved to manufacture. As we've shared in the past, PM as a network and as an individual site are individually approved as GMP manufacturing sites by the FDA. So we also have a very carefully thought through plan as to how to secure region by region to ensure that the FDA approvals are in place for all of our PMF sites.

我只想從營運層面說明，我們會針對每一家PMS走一套功能性的步驟，以確保他們——也就是他們具備生產能力，且已獲准生產。正如我們過去分享的，PM作為一個網路以及作為單一站點，均由FDA分別核准為GMP製造場址。因此，我們也有一套經過周密規劃的方案，按區域逐一落實，以確保我們所有PMF站點都具備FDA核准。

And as with any other manufacturing site, there's a set of steps you go through with what's called validation batches, which kind of proves out the manufacturing process and that you can consistently replicate that process. Let's remember, PYLARIFY was a first. We -- not only in PSMA PET, but in the scale of a new launch that had not been seen in many decades in a PMF network. We did it then. We're very confident we can do it again with PYLARIFY TruVu.

而且就像任何其他製造場址一樣，你會依照所謂的驗證批次（validation batches）走一套流程，這基本上是用來證明製造流程可行，並且你能夠一致地複製該流程。請記得，PYLARIFY是第一個。我們——不僅是在PSMA PET領域，而且在PMF網路中這種規模的新產品上市，在過去數十年都未曾見過。我們當時做到了。我們非常有信心，PYLARIFY TruVu也能再做到一次。

Matt Taylor, Jefferies.

Matt Taylor，Jefferies。

Hi, thanks for taking the question. On TruVu, I was wondering if you could talk a little bit about the pricing strategy with TPT and how much in the initial transition period can you realize? And can you give any high-level thoughts on how that could impact 2027?

嗨，謝謝讓我提問。關於TruVu，我想請教你們是否能談談搭配TPT的定價策略，以及在初期轉換期間你們能實現多少？另外，能否提供一些高層次的看法，這可能會如何影響2027年？

So Matt, it's Mary. Thanks for your question. I will share what I always share. We don't talk about pricing strategy. What I will say and what I think all of you from working so closely with us over the years are aware of is that transitional pass-through is a reimbursement mechanism that's available only in the hospital outpatient setting and only applies to traditional fee-for-service Medicare patients.

Matt，我是Mary。謝謝你的問題。我會分享我一向會說的：我們不談定價策略。我能說的是——我想你們多年來與我們密切合作也都知道——過渡性加付（transitional pass-through）是一種僅在醫院門診場景可用的給付機制，而且只適用於傳統按服務計費（fee-for-service）的Medicare病患。

And so we're very cognizant of how to ensure that, that the possibility and the opportunity of that coverage being available for that patient group is something that our customers are very aware of.

因此，我們非常留意如何確保：對於該病患族群而言，這項給付可能性與機會的可用性，能讓我們的客戶非常清楚。

And I don't think I need to say that it's certainly from our learnings with PYLARIFY, it's something we're very focused on to ensure that, that reimbursement status is clear and available to all of our hospital-based customers, especially those who have larger patient populations of traditional fee-for-service Medicare. What I -- we will not give forward guidance, obviously, to 2027. Yes, you have to wait later in the year for that, Matt. But as we said repeatedly throughout our script, we do see 2027 as a year of growth acceleration. So you can probably infer from that.

而且我想我不需要再多說，特別是從我們在PYLARIFY上的經驗學習來看，這是我們非常聚焦的重點，以確保該給付狀態對所有以醫院為主的客戶而言是清楚且可取得的，尤其是那些擁有較大傳統按服務計費Medicare病患族群的客戶。至於你問的——我們當然不會對2027年提供前瞻指引。是的，Matt，你得等到今年稍晚。但正如我們在講稿中反覆提到的，我們確實將2027年視為成長加速的一年。所以你大概可以由此推論。

Yuan Zhi, B. Riley.

Yuan Zhi，B. Riley。

Good morning. Maybe a question to Marianne or Amanda. On your radar, do you see any other F-18 or Gallium-68 PSMA imaging agent entering the market in the next couple of months? And which market or geographic areas do you anticipate some meaningful impact? Thank you.

早安。也許這個問題想請教Marianne或Amanda。就你們的觀察，在接下來幾個月內，是否會有其他F-18或Gallium-68的PSMA影像顯影劑進入市場？你們預期哪些市場或地理區域會受到較明顯的影響？謝謝。

You're welcome. I'm going to let Amanda take that for you.

不客氣。我讓Amanda來回答你。

Sure. Thanks for the question. So as you can probably imagine, we continuously monitor the marketplace, and we're watching for all types of agents that could enter the market. We remain steadfast on the franchise that we have set up through our prostate cancer franchise and PYLARIFY and the follow-on asset of PYLARIFY TruVu. So we will continue to monitor the marketplace, but we remain confident in the franchise that we've established, and we remain confident in the relationships that we have with our entire portfolio as well as within our nuclear medicine relationships.

好的。謝謝你的問題。正如你可以想像的，我們會持續監測市場，並關注各類可能進入市場的顯影劑。我們仍然堅定聚焦於我們透過前列腺癌產品組合、PYLARIFY以及後續資產PYLARIFY TruVu所建立的產品版圖。因此，我們會持續監測市場，但我們對已建立的產品版圖仍有信心，也對我們在整體產品組合以及核醫相關合作關係中的關係網絡保持信心。

So I'll just add there. I think as anyone who follows the space is aware, we follow there are two copper-based products that are in development, late stage that have the potential to enter the market at some point in the future. We don't see any of that occurring in 2026. And -- but we continue to follow their progress and their programs. We're also aware that there are two other gallium-based products worldwide, PSMA gallium-based products that could then have potential for application into the United States.

我再補充一下。我想任何關注這個領域的人都知道，我們一直在追蹤有兩個以銅為基礎、處於後期開發階段的產品，未來某個時間點有可能進入市場。我們不認為這會在2026年發生。但——我們會持續追蹤它們的進展與計畫。我們也知道全球還有另外兩個以鎵為基礎的產品，也就是PSMA鎵基產品，未來可能有機會應用到美國市場。

But again, we don't see those as imminent on our high. We have and have purposely developed a portfolio approach to our nuclear medicine customer base, we feel that, that will keep us highly competitive and successful in our interactions with not only our prostate cancer franchise, but our neurology franchise and any other therapeutic areas that we enter with that customer base.

但同樣地，我們不認為那些會在短期內迫近。我們已經、而且是刻意地，針對核醫客戶群採取產品組合式（portfolio）策略；我們認為這將使我們在與該客戶群的互動中保持高度競爭力並取得成功，不僅是在前列腺癌產品版圖上，也包括我們的神經學產品版圖，以及我們未來可能透過該客戶群進入的任何其他治療領域。

Paul Choi, Goldman Sachs.

Paul Choi，Goldman Sachs。

We'll move to our next question.

我們進入下一個問題。

Andy Hsieh, William Blair.

Andy Hsieh，William Blair。

Great. Thanks for taking our question. Maybe just a kind of an educational one for us. Mary, you mentioned about the high-energy cyclotron that's required for TruVu. So can you give us a sense of what percentage of your PF network is equipped with such equipment? And do you foresee longer term, all of them will be transitioned to the high-energy versions? And just maybe comment as you go through the hardware transition, any sort of supply -- maximum supply versus what you expected for the original PYLARIFY.

很好，謝謝讓我們提問。也許這是一個偏教育性的問題。Mary，你提到TruVu需要高能量迴旋加速器。你能否讓我們了解一下，你們的PF網路中有多少比例已配備這類設備？長期來看，你是否預期全部都會轉換為高能量版本？另外，當你們進行硬體轉換時，能否談談供應面——最大供應量相較於你們對原始PYLARIFY的預期？

Just kind of get a sense of the ramp-up and also from a production perspective.

想藉此了解爬坡速度，以及從產能角度的情況。

Sure. And it's a great question. I did address a little bit of this in my remarks. But when we look out at what the current PMF network is that services PYLARIFY and will service PYLARIFY TruVu in the future, we estimate that already 70% of that, and I'll call it a fleet. It's a fleet of manufacturing sites.

當然，這是個很好的問題。我在發言中已稍微提到一些。不過，當我們看目前服務PYLARIFY、未來也將服務PYLARIFY TruVu的PMF網路時，我們估計其中已有70%——我把它稱作一個「車隊」。這是一個由製造場址組成的車隊。

We estimate that 70% of our fleet is already serviced by high energy cyclotrons. And therefore, that gives us confidence that what we see as the value add of PYLARIFY TruVu is directly transferable into the market.

我們估計，我們這個車隊中有70%已由高能量迴旋加速器提供支援。因此，這讓我們有信心：我們所看到的PYLARIFY TruVu的附加價值，可以直接轉移到市場上。

I do want to address operationally something you mentioned about transition of hardware to PYLARIFY TruVu. If you understand the operational basis of PMF, they essentially use a cyclotron to produce isotopes and the predominant isotope is obviously F-18. But then F-18 then is run through a manufacturing process that's called a synthesis box. And it is on the synthesis box that the product-specific elements are added in to form the final product. And so it is a different -- and they call them -- this is the synthesis boxes have different names, but for all intents and purposes, they call the objects cassettes that they attach to the synthesis boxes to complete the final production of the F-18 labeled isotope imaging agent.

我也想從營運角度回應你提到的硬體轉換到PYLARIFY TruVu這件事。如果你了解PMF的營運基礎，他們基本上使用迴旋加速器來生產同位素，而主要的同位素顯然是F-18。接著，F-18會進入一個稱為合成盒（synthesis box）的製造流程；產品特定的元素是在合成盒上加入，以形成最終產品。因此，這是不同的——他們稱之為——合成盒有不同名稱，但就所有實務目的而言，他們把連接到合成盒、用來完成F-18標記同位素影像顯影劑最終生產的物件稱為卡匣（cassettes）。

In this case, they will use a different set of cassettes to produce PYLARIFY TruVu compared to what they were using for PYLARIFY and compared to the other types of cassettes they use to produce other F-18-based isotopes like SEG or the other isotopes that they're producing. To the other part of your question, I'll say that the incredible success of PSMA PET imaging agents as well now as the emerging building success of PET-based Alzheimer's disease agents has incredibly invigorated the PMF network chain that service the United States medical market. And it's a clear opportunity to them and for them to invest in their operational readiness with higher energy cyclostomes.

在這個案例中，他們會使用一套不同的卡匣來生產PYLARIFY TruVu，相較於他們用於PYLARIFY的卡匣，也不同於他們用來生產其他F-18同位素（例如SEG或他們正在生產的其他同位素）的卡匣。至於你問題的另一部分，我會說：PSMA PET影像顯影劑的巨大成功，以及現在以PET為基礎的阿茲海默症顯影劑逐步建立的成功，已大幅振興了服務美國醫療市場的PMF網路鏈。對他們而言，這清楚是一個機會，也促使他們投資於以更高能量迴旋加速器提升營運就緒度。

I can't speak to their -- to what their capital plans for investment are, but I can speak to what has clearly been a renaissance of PMF-based products in the United States and what that means for their business case. Again, just to reiterate the first part of your question, the PMS that produce PYLARIFY, 70% of our dose volume currently comes from PMFs that have high energy cyclotones in place. I hope that was clear and helpful.

我無法評論他們——他們的資本投資計畫會是什麼，但我可以談的是：在美國，PMF型產品顯然出現了一波復興，以及這對他們商業論證（business case）的意義。再次重申你問題的第一部分：目前生產PYLARIFY的PMS中，我們現有劑量量（dose volume）的70%來自已配置高能量迴旋加速器的PMF。我希望這樣說明清楚且有幫助。

Paul Choi, Goldman Sachs.

Paul Choi，Goldman Sachs。

Hi. Thank you, and apologies for fumbling the question earlier. My question is on gross margins, which looked better this quarter than it has in a little while, and this is ahead of your potential switch to TruVu down the line and getting to scale. So my question is, is this sort of a more normalized run rate? Or is this sort of a one-off for this quarter as we think about sort of the margin profile over the short to intermediate term?

嗨，謝謝，也抱歉我剛才問題問得有點亂。我想問的是毛利率：本季看起來比過去一段時間更好，而且這還是在你們未來可能轉換到TruVu、並逐步達到規模之前。因此我的問題是：這算是一個較正常化的運行水準（run rate）嗎？還是說這只是本季的一次性因素？我們在看短期到中期的毛利率輪廓時，應該怎麼理解？

Paul, I appreciate the question. When we gave guidance, I don't know, back whenever it was end of February, I think I noted that we would be between sort of 65% and 66%. We're probably going to end up trailing towards the higher end of that particular range. So there is a little bit of a one-off. I mean we did have a lot of benefit coming from PYLARIFY and DEFINITY volumes.

Paul，我很感謝這個問題。我們在給出指引時——我不確定是什麼時候，大概是2月底——我記得我提到會落在約65%到66%之間。我們最後可能會更接近該區間的高端。所以確實有一點一次性因素。我的意思是，我們確實從PYLARIFY和DEFINITY的銷量中獲得了不少助益。

We had the spec divestiture, which is the majority of the year-over-year change, but that was offset by the PLA pricing headwind and as well as the inclusion of LMI and Evergreen into the mix. So that was intentional that was with the spec divestiture in the sense that, that gives us sort of the tailwind to offset the PYLARIFY pricing headwinds that we see. So I would still have you model more like where I had guided, but maybe towards the higher end of the range.

我們進行了 spec 資產剝離，這是年對年變動的主要部分，但這被 PLA 定價逆風以及將 LMI 與 Evergreen 納入組合所抵銷。因此，從 spec 資產剝離的角度來看，這是有意為之，因為它在某種程度上為我們提供了順風，以抵銷我們所看到的 PYLARIFY 定價逆風。所以我仍會建議你們的模型更接近我先前所指引的水準，但可能偏向區間的高端。

(Operator Instructions)

（接線員指示）

Justin Walsh, Jones Trading.

Justin Walsh，Jones Trading。

Hi, thanks for taking the question. I'm wondering if you can comment on the process for turning PNT2003's tentative approval into a potential full approval in June. And wondering if you can remind us if PNT2003 is included in the current guidance.

嗨，謝謝讓我提問。我想請你們評論一下，將 PNT2003 的暫定核准在六月轉為可能的正式核准的流程。另外也想請你們提醒我們，PNT2003 是否已納入目前的財測指引。

I'll start with your question about approval, and then Bob can speak to what he is included in the guidance or not. As I mentioned in my comments, PNT2003 did receive tentative approval in March from the FDA. And for them having offered tentative approval, what they convey with that is that essentially their review is complete and they find the basis of approval for the product. However, because there is a Hatch-Waxman stay with this product, the final approval will require, let's call it, three different things.

我先回答你關於核准的問題，接著 Bob 可以說明它是否被納入指引。如我在評論中提到的，PNT2003 在三月已獲 FDA 暫定核准。FDA 提供暫定核准所傳達的是：基本上他們的審查已完成，並且認為該產品具備核准的基礎。然而，由於此產品存在 Hatch-Waxman 暫緩（stay），最終核准將需要——我們姑且稱之為——三件不同的事情。

The first is either the expiration of or the resolution of the Hatch-Waxman stay. And what that means is that is -- it's essentially a challenge about whether the original product patents are being violated by your application.

第一是 Hatch-Waxman 暫緩期的到期或解除／解決。而這代表的是——本質上是一項挑戰：你的申請是否侵犯了原研產品的專利。

And to the extent that if it's not, if you need to have one or two things happen, the 30-month period can expire or the FDA can rule ahead of that, that they'd be finding that there is no infringement for the product. There's also then related to that, there is the disposition of kind of related legal proceedings, which again, is more of a legal issue. And we will, of course, wait for that.

若確實未侵權，則需要發生一到兩件事：30 個月期間到期，或 FDA 在此之前作出裁定，認定該產品不存在侵權。此外，還有與此相關的法律程序之處置，這同樣更偏向法律議題。我們當然會等待其結果。

There was the Citizens petition also filed by Novartis and their request for reconsideration of that citizens' position, that was a 150-day period from when it was first filed.

另外，Novartis 也提出了公民請願（Citizens petition），並就該公民立場提出重新考量的請求；自首次提出起有 150 天的期間。

So all of that together, I think what we're saying and what we're trying to communicate is that once we have final approval from the FDA, we can technically launch the product. And we see that occurring again, either at either the expiration of the Hatch-Waxman period or the resolution of it and then the related legal findings.

因此綜合以上，我想我們所說、也試圖傳達的是：一旦我們取得 FDA 的最終核准，我們在技術上就可以上市該產品。而我們預期這會發生在——要嘛是 Hatch-Waxman 期間到期，要嘛是其獲得解決，並且伴隨相關法律認定之後。

Having said that, what I would also like to communicate is our decision on ultimate launch date will follow the comments you've heard me say repeatedly throughout my remarks, and that is we will ensure that there is launch readiness, customer preparedness and that all coding and reimbursement related benefits are in place for the product before we take it to market.

話雖如此，我也想傳達的是：我們對最終上市日期的決定，將遵循你們在我發言中反覆聽到的重點，也就是——在我們將產品推向市場之前，我們會確保上市準備就緒、客戶準備就緒，且所有與編碼與給付（reimbursement）相關的配套與效益都已到位。

And with regard to what's in the guidance, I think we had said during the beginning of the year that any of the approvals that we would be getting for products this year were not considered and we should not be sort of in any material way, embedded into the 2026 total revenue expectation. So I would -- it's not in the model effectively.

至於指引中包含哪些內容，我想我們在年初就說過，今年可能取得的任何產品核准都未被納入考量，也不應以任何重大方式被嵌入 2026 年總營收預期之中。所以我會說——它實際上並未被納入模型。

Matt Taylor, Jeffries.

Matt Taylor，Jefferies。

Hi. Thanks for taking the follow-up. I just had a follow-up on guidance. So I wanted to ask because of the strong start with PYLARIFY, when you guided before, you were talking about the potential for pricing pressure and baking in some conservatism. I guess I just wanted to confirm, it doesn't seem like you're seeing that, are you? And I guess, the -- it sounds like you're being conservative with the new CEO coming in, it makes sense. But would you have raised guidance if not for that?

嗨，謝謝讓我追問。我想再追問一下指引。由於 PYLARIFY 開局強勁，你們先前給指引時談到可能的定價壓力，並在其中加入一些保守假設。我想確認一下：看起來你們並沒有看到那種情況，對嗎？另外——聽起來你們在新 CEO 即將上任時採取保守作法，這很合理。但如果不是因為這個因素，你們會上調指引嗎？

You know what, Matt, I'm going to give Bob a break on this one and answer your question, which I think in large part, Matt, you may have answered for yourself with the way you phrased it. We're early in the year. We're really happy with our first quarter results.

你知道嗎，Matt，這題我讓 Bob 休息一下，由我來回答。我想在很大程度上，Matt，你用提問的方式其實已經替自己回答了。我們現在還在年初。我們對第一季的結果非常滿意。

But we're also sitting pretty much right in front of the CEO change, which I've also been fairly transparent about. And I think for all of those reasons, we felt that the most prudent thing we could do was hang with the guidance that we had already offered, which we felt was already a great outlook for our company.

但我們也幾乎正處在 CEO 交接之前，這點我也一直相當透明。基於所有這些原因，我們認為最審慎的作法，就是維持我們先前已提供的指引；我們也認為那已經是對公司非常好的展望。

Anthony Petrone, Mizuho Financial Group.

Anthony Petrone，Mizuho Financial Group。

Popping back and forth, but I wanted to press again on Neuraceq for a moment. Maybe just a reset on Neuraceq and the landscape there for beta amyloid tests and where is the Neuraceq share today relative to competitors? I think GE is out there with Vismo and Lilly has Amyvid. What is the expectation for a higher attach rate to the two disease-modifying agents going forward? And the prescription trends for Alzheimer's disease look bullish. Just an update on that market as we look into the back end of the year. Thanks.

我來回切換一下，但我想再就 Neuraceq 追問片刻。也許請先幫我們重新梳理一下 Neuraceq，以及 β 類澱粉蛋白檢測的市場格局；目前 Neuraceq 的市占相對於競品如何？我想 GE 有 Vismo，Lilly 有 Amyvid。未來對兩個疾病修飾療法（disease-modifying agents）的更高搭配使用率（attach rate）有何預期？而阿茲海默症的處方趨勢看起來偏多。請就我們展望今年下半年時，更新一下該市場狀況。謝謝。

So Anthony, I'll start with this and then Amanda can jump in if I miss anything. But I think what you've heard us repeat now consistently is Neuraceq holds two places of note in the beta amyloid imaging market. First, -- it is the fastest agent growing of the three agents that are currently present in the market. And second, it holds the second highest share already in that market. Now I'm not going to offer specific market share, again, for the reason that these are estimated figures.

Anthony，我先回答，若我漏了什麼 Amanda 可以補充。我想你們已經聽到我們一再重申：Neuraceq 在 β 類澱粉蛋白影像市場有兩個值得注意的定位。第一——在目前市場上的三種藥劑中，它是成長最快的。第二，它在該市場已擁有第二高的市占。我不會提供具體市占數字，原因同樣是這些是估算值。

We have to triangulate back into them. And I don't think it's germane. I think what's germane to hear from us is that we are investing in Neuraceq to ensure that it has expanded availability and availability is key in this market as it is in the other [PET radiotracer] market.

我們必須透過多方資料回推校準。我認為那並非重點。我認為重點是：我們正在投資 Neuraceq，以確保其供應可得性擴大；而在這個市場中，可得性是關鍵，就如同在其他 [PET 放射性示蹤劑] 市場一樣。

That is our major investment thesis for 2026 that we can accomplish two things -- or actually, I'll take it now to a third thing. First, we can use our portfolio approach to have our customers use Neuraceq as their beta-amyloid imaging agent of choice based on their relationship with Lantheus and the customer service we provide. Second, that we can drive deeper penetration in existing Neuraceq accounts that goes along with the great growth we're seeing in the market because of, as you referenced, the adoption of and the continued adoption of the beta amyloid therapeutic agents. And third, that we can expand the footprint of where the product is manufactured.

這是我們 2026 年的主要投資論點：我們可以達成兩件事——或者其實我現在把它擴展到第三件事。第一，我們可以運用產品組合策略，基於客戶與 Lantheus 的關係以及我們提供的客戶服務，讓客戶將 Neuraceq 作為其首選的 β 類澱粉蛋白影像藥劑。第二，我們可以在既有 Neuraceq 客戶中推動更深的滲透，這也與我們看到的市場強勁成長相一致，因為——如你所提到——β 類澱粉蛋白治療藥物的採用以及持續採用。第三，我們可以擴大該產品的製造據點版圖。

So that again, it serves number 2, which is deepening penetration in existing accounts, but it also gives us access to new accounts out there. And these are all benefits that we had considered as we considered the LMI acquisition because as a company at their size and their financial capabilities before the acquisition, they just did not have the bandwidth to take on some of these opportunities. We do and we will, and we see that coming back to us not only in '26 already, but certainly in '27 and beyond. Amanda, did I leave anything out of note to that?

如此一來，它再次服務於第二點——加深在既有客戶的滲透——同時也讓我們能接觸到新的客戶。這些都是我們在考量 LMI 併購時納入的效益，因為以他們在併購前的公司規模與財務能力，確實沒有足夠的資源承擔其中一些機會。我們有，而且我們會做；我們預期回報不僅會在 2026 年開始顯現，當然也會在 2027 年及之後持續。Amanda，我有漏掉任何重要點嗎？

You did a fantastic job. Maybe I'll just add a few key points that Neuroceq is really addressing a large and expanding market. And so it's benefiting from that market. And as Mary Anne shared, the adoption of the Alzheimer's CMT is critical. But also the other point to add in is that the guidelines favor earlier diagnostic usage.

你講得非常好。我可能只補充幾個重點：Neuroceq（原文如此）確實正在對應一個龐大且持續擴張的市場，因此也受惠於該市場。如 Mary Anne 所分享，阿茲海默症 CMT 的採用至關重要。另外還要補充的一點是：指引（guidelines）更偏好更早期的診斷使用。

So that's an important component. And then finally, I'll just kind of anchor down on the ability for us to work with our nuclear medicine customers from a Lantheus portfolio perspective is really advantageous for us and for our customers. So I would just like to add that.

這是重要的組成部分。最後，我想再強調：我們能以 Lantheus 產品組合的角度，與核醫客戶合作，對我們與客戶而言都非常有利。所以我想補充這一點。

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.

各位女士先生，目前沒有進一步提問。感謝各位參與今天的電話會議。本次會議到此結束。您現在可以掛線，祝您有美好的一天。