Lantheus Holdings Inc (LNTH) 2025 Q2 法說會逐字稿

Good morning. Welcome to Lantheus second quarter 2025 conference call. (Operator Instructions) This call is being recorded, and a replay will be available in the investors section of the company's website approximately two hours after the completion of the call and will be archived for at least 30 days.

早安.歡迎參加 Lantheus 2025 年第二季電話會議。（操作員指示）本次通話正在錄音，通話結束後約兩小時，公司網站的投資者部分將提供重播，並將存檔至少 30 天。

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

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

Thank you. Good morning. With me today are Brian Markison, our CEO; Paul Blanchfield, our President,; nd Bob Marshall, our CFO. We will begin with prepared remarks, and then take your questions.

謝謝。早安.今天與我一起的有我們的執行長 Brian Markison、我們的總裁 Paul Blanchfield 和我們的財務長 Bob Marshall。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 second-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 2025 年第二季的表現。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 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.

任何評論都可能包含前瞻性陳述。由於我們向美國證券交易委員會提交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。

Discussions will also include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included in the Investors section of our website.

討論還將包括某些非公認會計準則財務指標。這些指標與最直接可比較的 GAAP 財務指標的對帳已包含在我們網站的投資者部分中。

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

現在我將把電話轉給我們的執行長布萊恩。

Thank you, Mark, and thank you for joining us today.

謝謝你，馬克，謝謝你今天加入我們。

This morning, we announced second-quarter results that were below expectations and also lowered our financial outlook for the remainder of 2025. Before I go into the broader steps that we are taking to diversify our business and establish a new growth trajectory for the company, I want to drill down on PYLARIFY and the current dynamics in the PSMA PET market.

今天上午，我們宣布了低於預期的第二季業績，並下調了 2025 年剩餘時間的財務展望。在我詳細介紹我們為實現業務多元化和為公司建立新的成長軌跡而採取的更廣泛措施之前，我想深入了解 PYLARIFY 和 PSMA PET 市場的當前動態。

In the back half of the quarter, the confluence of MUC-based reimbursements and aggressive discounting by what had been a somewhat dormant F-18 competitor led some economically sensitive customers to reassess their choice of PSMA agents. This led to the renegotiation of some existing strategic partnerships as well as a conscious decision to walk away from those volumes at certain accounts that requested pricing terms that were not in the long-term interest of our PSMA PET franchise.

在本季後半段，基於 MUC 的報銷政策與原本處於休眠狀態的 F-18 競爭對手的大幅折扣相結合，導致一些對經濟敏感的客戶重新評估他們對 PSMA 代理商的選擇。這導致我們重新談判了一些現有的策略夥伴關係，並有意識地決定放棄某些帳戶的交易量，因為這些帳戶要求的定價條款不符合我們 PSMA PET 特許經營的長期利益。

PYLARIFY also continues to be concentrated in large institutions that, due to constraints, continue to grow at a slower rate than the overall market. However, our strategic partnership agreements have proven and will continue to prove effective at retaining the vast majority of our customers who recognize PYLARIFY's clinical differentiation. This is reflected in our US quarterly volume growth, 2% year over year and over 4% sequentially.

PYLARIFY 也繼續集中在大型機構中，由於受到限制，這些機構的成長速度持續低於整體市場。然而，我們的策略合作協議已經證明並將繼續證明能夠有效地留住絕大多數認可 PYLARIFY 臨床差異化的客戶。這反映在我們美國季度銷量的成長上，年增 2%，季增超過 4%。

Paul will provide greater detail, but I want to be clear. We understand the dynamics that we faced during the quarter, how we expect these dynamics to evolve in the second half of the year, and how these changes impact our business. We have implemented actions to ensure we maintain our market leadership and maximize the long-term value of the franchise.

保羅將提供更多細節，但我想說清楚。我們了解本季面臨的動態，我們預計這些動態將如何發展，以及這些變化如何影響我們的業務。我們已採取行動，確保保持市場領先地位並最大化特許經營的長期價值。

These actions include conducting a continuous and comprehensive review of our customer base, expanding our strategic partnerships to the smaller high growth accounts, enhancing our availability and geographic reach, proactively communicating the value proposition of PYLARIFY and our growing innovative radiopharmaceutical portfolio including Neuraceq, and executing a disciplined pricing strategy. Lantheus has a leading role in the prostate cancer market, and our strategy and actions will enable the sustained growth and success of this franchise.

這些行動包括對我們的客戶群進行持續全面的審查，將我們的策略合作夥伴關係擴展到較小的高成長客戶，增強我們的可用性和地理覆蓋範圍，積極傳達 PYLARIFY 的價值主張以及我們不斷增長的創新放射性藥物組合（包括 Neuraceq），並執行嚴格的定價策略。Lantheus 在前列腺癌市場佔據領先地位，我們的策略和行動將推動該特許經營業務的持續成長和成功。

Underscoring the value of this franchise, we announced today that the FDA has accepted our NDA for a new formulation of PYLARIFY, which will increase batch size by approximately 50%, enabling increased patient access, supply resilience, and enhanced production efficiency, all to the benefit of our customers and patients. Our prostate cancer franchise will be further enhanced in the long term by the development of LNTH-2401 and 2402, our GRPR, radio-diagnostic, and radiotherapeutic product candidates.

為了強調這項特許經營權的價值，我們今天宣布，FDA 已經接受了我們對 PYLARIFY 新配方的 NDA，這將使批量大小增加約 50%，從而增加患者的可及性、供應彈性和提高生產效率，所有這些都將使我們的客戶和患者受益。透過開發 LNTH-2401 和 2402、我們的 GRPR、放射診斷和放射治療候選產品，我們的前列腺癌特許經營權將在長期內進一步增強。

Part of our decision to remain disciplined with our pricing is to preserve the value of our PSMA PET franchise in anticipation of launching our new PSMA PET agent. If approved, we believe it will be eligible for three years of transitional pass-through payment status and will reinvigorate growth.

我們決定保持定價紀律的部分原因是為了在推出新的 PSMA PET 代理商之前保留 PSMA PET 特許經營權的價值。如果獲得批准，我們相信它將有資格獲得三年的過渡性轉撥支付地位，並將重振成長。

Fundamental differences in the chemical structure of PSMA PET imaging agents significantly influence their performance. For example, we have heard firsthand from HCPs, they have begun to see increasing numbers of false positives in recurrent patients from their real-world use of competing F-18 agents, which, while anecdotal, is a risk specifically called out in their package insert. And with respect to gallium, the shorter half-life, lower positron yield and lower spatial resolution are well known.

PSMA PET 造影劑化學結構的根本差異對其性能有顯著影響。例如，我們從 HCP 直接獲悉，他們在現實世界中使用競爭性 F-18 藥物時，開始發現復發患者中假陽性的數量不斷增加，雖然這只是傳聞，但卻是其藥品說明書中特別指出的風險。而對於鎵而言，其半衰期較短、正電子產額較低、空間解析度較低是眾所周知的。

Beyond PYLARIFY, we continue to advance our strategy, diversify our portfolio, and build talent and capabilities needed to lead at all stages of the radiopharmaceutical value chain. The acquisitions of Evergreen on April 1s and Life Molecular on July 21 add complementary capabilities, bring immediate growth drivers, expand our pipeline, and importantly, diversify our revenue, positioning us for long term growth.

除了 PYLARIFY，我們還將繼續推進我們的策略，多樣化我們的產品組合，並培養在放射性藥物價值鏈各個階段發揮領導作用所需的人才和能力。我們於 4 月 1 日收購了 Evergreen，並於 7 月 21 日收購了 Life Molecular，這增強了互補能力，帶來了直接的成長動力，擴大了我們的產品線，更重要的是，實現了收入多元化，為我們的長期成長奠定了基礎。

We grew our neurology franchise with the addition of Neuraceq, our globally approved F-18 PET imaging agent used to detect beta amyloid plaques in patients evaluated for Alzheimer's disease. In June, the FDA approved an expanded label for Neuraceq, enabling broader diagnosis, selection, and monitoring of appropriate patents for amyloid-targeting therapies.

我們透過增加 Neuraceq 擴大了我們的神經病學特許經營權，Neuraceq 是我們全球認可的 F-18 PET 成像劑，用於檢測阿茲海默症患者的 β 澱粉樣斑塊。6 月，FDA 批准了 Neuraceq 的擴展標籤，從而可以更廣泛地診斷、選擇和監測針對澱粉樣蛋白治療的適當專利。

This broader label combined with the continued adoption of Alzheimer's therapeutics and advancements in therapeutic development programs reinforces our belief in the significant growth potential of the US Alzheimer's disease PET imaging market, one we estimate could exceed $1.5 billion by the end of the decade and reach approximately $2.5 billion by the mid 2030s.

這個更廣泛的標籤，加上阿茲海默症療法的持續採用和治療開發項目的進步，增強了我們對美國阿茲海默症 PET 成像市場巨大增長潛力的信心，我們估計到本世紀末該市場規模可能超過 15 億美元，到 2030 年代中期將達到約 25 億美元。

In fact, the recent AAIC meeting highlighted a number of therapeutic programs rapidly advancing in the clinic. Most of the more promising programs already incorporate at least one of our amyloid or tau tracers for selection criteria, monitoring, and follow up.

事實上，最近的 AAIC 會議強調了一些在臨床上快速進展的治療方案。大多數更有前景的項目已經結合了我們的至少一種澱粉樣蛋白或 tau 示踪劑，用於選擇標準、監測和後續追蹤。

Looking ahead to the next 18 months, we expect to further expand our commercial portfolio and diversify our revenue streams with the launch of four additional radiopharmaceutical products, including our new F-18 PSMA PET formulation; MK-6240, our late-stage tau-targeted radiodiagnostic for Alzheimer's disease.; as well as OCTEVY and PNT2003, our registrational stage radiodiagnostic and therapeutic for neuroendocrine tumors. Taken together, we believe these strategic moves will solidify our position as the partner of choice for nuclear medicine and certainly drive future growth.

展望未來 18 個月，我們預計將進一步擴大我們的商業組合，並透過推出另外四種放射性藥物產品來實現收入來源的多樣化，包括我們的新 F-18 PSMA PET 製劑；MK-6240，我們針對阿爾茨海默病的後期 tau 靶向放射診斷藥物；以及 OCTEVY 和 PNT2003，我們註冊神經分泌治療和腫瘤的治療階段。總之，我們相信這些策略舉措將鞏​​固我們作為核醫學首選合作夥伴的地位，並必將推動未來的成長。

To underscore our confidence in our long-term strategy and our ability to execute, the Board has authorized a new $400 million stock repurchase program. This decision reflects our belief in the intrinsic value of the business and our commitment to deliver shareholder returns.

為了強調我們對長期策略和執行能力的信心，董事會批准了一項新的 4 億美元股票回購計畫。這項決定反映了我們對企業內在價值的信念以及我們為股東帶來回報的承諾。

It also signals our conviction in the strength of our pipeline, our significant free cash flow generation, and the durability of our financial position. By repurchasing shares, we are not only optimizing capital allocation, but also reinforcing our confidence in the future.

這也顯示了我們對我們的產品線實力、我們大量的自由現金流產生以及我們財務狀況的持久性的信心。透過回購股票，我們不僅優化了資本配置，也增強了對未來的信心。

I will now turn the call over to Paul to discuss the market dynamics and the actions we're taking in more detail. Paul?

現在我將把電話轉給保羅，更詳細地討論市場動態和我們正在採取的行動。保羅？

Thank you, Brian. Sales of PYLARIFY were $251 million during the quarter, down 8.3% versus last year. US volumes for PYLARIFY were up 2% year over year and more than 4% sequentially, both lower than our expectations.

謝謝你，布萊恩。PYLARIFY 本季的銷售額為 2.51 億美元，較去年同期下降 8.3%。PYLARIFY 在美國的銷量年增 2%，季增超過 4%，均低於我們的預期。

As Brian mentioned, in the back half of the quarter, PSMA PET competitive pricing pressures intensified, particularly from an F-18 competitor. And we experienced an increase in account losses which significantly impacted volume in the latter half of May and June.

正如 Brian 所提到的，在本季後半段，PSMA PET 競爭定價壓力加劇，尤其是來自 F-18 競爭對手的壓力。我們的帳戶損失有所增加，這對 5 月下半月和 6 月的交易量產生了重大影響。

The majority of the impact occur in accounts that had greater exposure to MUC-based reimbursement and a greater focus on economics. We made the intentional decision to remain disciplined with our pricing strategy, even at the cost of losing select accounts, rather than chase volume and harm the long-term value of our PSMA PET franchise.

大部分影響發生在更多地接觸基於 MUC 的報銷且更注重經濟的帳戶。我們有意決定嚴格執行我們的定價策略，即使以失去部分客戶為代價，也不會追求銷售並損害我們的 PSMA PET 特許經營權的長期價值。

Additionally, those competitive price offerings, combined with our MUC-based reimbursement, led to an increase in renegotiations of some existing partnerships, resulting in further net price compression during the quarter. These dynamics overshadowed the progress we made in expanding strategic partnerships with smaller later adopters where our volume growth outpaced that of our larger accounts.

此外，這些具有競爭力的價格，加上我們基於 MUC 的報銷，導致一些現有合作夥伴關係的重新談判增加，從而導致本季度淨價格進一步壓縮。這些動態掩蓋了我們在擴大與較小後期採用者的策略夥伴關係方面所取得的進展，在這些合作夥伴關係中，我們的交易量成長超過了較大帳戶的成長。

Importantly, our strategic partnerships which cover the vast majority of our business have been effective on multiple fronts. First, they have enabled us to maintain and grow volumes with a significantly higher market share in contracted the non-contracted accounts, though we are increasingly co-existing with gallium, even within contracted accounts.

重要的是，我們的策略夥伴關係涵蓋了我們絕大多數的業務，並在多個方面發揮了作用。首先，它們使我們能夠維持和增加銷量，在合約和非合約帳戶中佔有更高的市場份額，儘管我們越來越多地與鎵共存，即使在合約帳戶中也是如此。

Second, they have largely leveled the playing field related to MUC-based reimbursement. And finally, they frequently offer us a last look when competitive price offers arise, which lets us decide to renegotiate when doing so is in the long term interest of the franchise or, in some cases, walk away from dose volume.

其次，他們在很大程度上創造了與基於 MUC 的報銷相關的公平競爭環境。最後，當出現有競爭力的價格報價時，他們經常會讓我們最後考慮一下，這讓我們決定是否重新談判，如果這樣做符合特許經營的長期利益，或者在某些情況下放棄劑量。

As we look ahead to the remainder of the year, we expect volume growth to continue to be positive, albeit below that of the broader market. We will also see further net price compression as recently renegotiated contracts annualized and 340B or best price resets, particularly in the fourth quarter of 2025 as a result of the two-quarter lag in government price reporting.

展望今年剩餘時間，我們預計銷售成長將繼續保持正成長，儘管低於大盤水準。由於最近重新談判的合約年化以及 340B 或最佳價格重置，我們還將看到進一步的淨價格壓縮，特別是在 2025 年第四季度，由於政府價格報告滯後兩個季度。

I want to reaffirm Lantheus' commitment to maintaining PYLARIFY's market leadership. We are navigating current market dynamics with discipline and focus, guided by clear strategic principles that are in the long-term interest of the franchise.

我想重申 Lantheus 致力於保持 PYLARIFY 的市場領導地位。我們以紀律和專注度來應對當前的市場動態，並以符合特許經營長期利益的明確策略原則為指導。

PYLARIFY will continue to command a premium price in the market. This is driven by PYLARIFY's clear and compelling clinical performance, which is an area we are increasing our emphasis specifically through increased investment in our medical affairs function.

PYLARIFY 將繼續在市場上保持高價。這是由 PYLARIFY 清晰且引人注目的臨床表現所推動的，我們正透過增加對醫療事務功能的投資來特別重視這一領域。

We are preparing to commercialize our new PSMA PET agent, with the FDA having recently accepted the NDA and providing a March 6, 2026, PDUFA date. We expect this new formulation to enhance production efficiency and increased batch sizes, which will ultimately improve both patient and customer access.

我們正準備將我們的新 PSMA PET 藥物商業化，FDA 最近接受了 NDA 並提供了 2026 年 3 月 6 日的 PDUFA 日期。我們期望這種新配方能夠提高生產效率並增加大量，最終改善患者和客戶的使用體驗。

If approved, we expect to introduce this new agent to the market upon receiving coding, coverage, and payment, including a HCPCS code and transitional pass-through payment status. We expect this to level the reimbursement playing field, enabling HCPs to make decisions that reflect the strengths of our clinical profile and the differentiated value of our PSMA PET franchise.

如果獲得批准，我們預計在收到編碼、覆蓋範圍和付款（包括 HCPCS 代碼和過渡轉付狀態）後將這種新藥物推向市場。我們期望這將使報銷競爭環境更加公平，使 HCP 能夠做出反映我們臨床概況的優勢和 PSMA PET 特許經營的差異化價值的決策。

As I mentioned, we are also doing more to reinforce PYLARIFY's clinical differentiation based on fundamental differences in the chemical structures of the currently approved PSMA PET agents and the important differences, including the label of the only other F-18 agent on the market.

正如我所提到的，我們還在做更多工作來加強 PYLARIFY 的臨床差異化，該差異化基於目前批准的 PSMA PET 藥物的化學結構的根本差異以及重要差異，包括市場上唯一的其他 F-18 藥物的標籤。

Our medical affairs team is focused on communicating PYLARIFY's clinical attributes which are different from other agents on the market and to be clear with HCPs about how that can translate to the best care for patients.

我們的醫療事務團隊致力於傳達 PYLARIFY 與市場上其他藥物不同的臨床屬性，並向 HCP 明確說明如何將其轉化為對患者的最佳護理。

We have new leadership in medical affairs and are confident that updated education and ongoing evidence generation will further support PYLARIFY while we all prepare for future launches and the advancement of our expanded pipeline.

我們在醫療事務方面有了新的領導，並相信更新的教育和持續的證據生成將進一步支持 PYLARIFY，同時我們都為未來的發布和擴展管道的進步做好準備。

Finally, we continue to prioritize exceptional customer service and long-term partnerships with nuclear medicine departments. Given the current marketplace dynamics, Brian and I have worked closely with our commercial teams to conduct a comprehensive review of our customer base, including a bottoms-up evaluation of our existing contracts; and have actively engaged with customers, including those who have shifted to competing products.

最後，我們繼續優先考慮卓越的客戶服務和與核子醫學部門的長期合作。鑑於目前的市場動態，Brian 和我與我們的商業團隊密切合作，對我們的客戶群進行了全面審查，包括對我們現有合約的自下而上的評估；並積極與客戶接觸，包括那些已經轉向競爭產品的客戶。

Through this listening tour, we've developed a conclusive understanding of the key drivers behind their decisions. Several customers noted the transitive nature of TPT reimbursement and that, in some cases, the impact had been larger than they anticipated.

透過這次傾聽之旅，我們對他們決策背後的關鍵驅動因素有了最終的了解。一些客戶注意到 TPT 報銷的過渡性，並且在某些情況下，其影響比他們預期的要大。

They also shared their real-world clinical experiences with competing agents, most notably an F-18 agent that has resulted in an increase in false positive lesions in recurrent patients, which is expressly mentioned in that competitor's label. This reinforces our belief that our educational programs are needed and will resonate with providers.

他們還分享了與競爭藥物在現實世界中的臨床經驗，最值得注意的是 F-18 藥物，該藥物導致復發患者的假陽性病變增加，這在該競爭對手的標籤中明確提到。這強化了我們的信念：我們的教育計畫是必要的，並且會引起提供者的共鳴。

We are encouraged by the growing interest across the nuclear medicine community in our other products and pipeline, particularly in Alzheimer's disease, including Neuraceq and our late-stage tau and beta amyloid programs, as well as PNT2003 and OCTEVY, both for neuroendocrine tumors.

我們感到鼓舞的是，核醫學界對我們的其他產品和管道的興趣日益濃厚，特別是在阿茲海默症領域，包括 Neuraceq 和我們後期的 tau 和 β 澱粉樣蛋白項目，以及用於神經內分泌腫瘤的 PNT2003 和 OCTEVY。

We understand the current market dynamics, are taking steps to address them, and believe our disciplined approach to pricing based on PYLARIFY's clinical differentiation and our expanding commercial portfolio will maximize the value of the franchise.

我們了解當前的市場動態，正在採取措施應對這些動態，並相信我們基於 PYLARIFY 的臨床差異化和不斷擴大的商業組合而採取的嚴謹定價方法將最大限度地提高特許經營的價值。

In other areas of the portfolio, DEFINITY continued to perform well, up 7.5% year over year despite competitors fully returning to the market after some prior supply disruptions. We continue to believe DEFINITY's long-term success remains driven by its proven clinical and commercial value, long-standing track record of clinical application, and our ongoing operational excellence.

在投資組合的其他領域，儘管競爭對手在先前的供應中斷後全面重返市場，但 DEFINITY 仍然表現良好，比去年同期成長 7.5%。我們始終相信，DEFINITY 的長期成功仍然源自於其經過驗證的臨床和商業價值、長期的臨床應用記錄以及我們持續的卓越營運。

I will now turn the call over to Bob.

我現在將電話轉給鮑伯。

Thank you, Paul. I will provide details of the second-quarter 2025 financials, focusing on adjusted results with comparisons to the prior year quarter unless otherwise noted.

謝謝你，保羅。我將提供 2025 年第二季度財務狀況的詳細信息，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。

Consolidated net revenue for the second quarter was $378 million, a decrease of 4.1%. Radiopharmaceutical Oncology, currently PYLARIFY, contributed $250.6 million of sales, down 8.3%, lower than previously expected. While US volumes were up over 4% sequentially, as described by Paul, Competitive dynamics have driven the net price environment lower than expected.

第二季合併淨營收為3.78億美元，下降4.1%。放射性藥物腫瘤學（現為 PYLARIFY）貢獻了 2.506 億美元的銷售額，下降 8.3%，低於先前的預期。正如保羅所述，儘管美國銷量環比成長超過 4%，但競爭動態導致淨價格環境低於預期。

Precision Diagnostics revenue of $115.8 million was up 3.3%. Highlights include sales of DEFINITY at $83.9 million, 7.5% higher; along with TechneLite revenue of $25 million, down 11.4% due to a prior year comp that included a greater opportunistic sales to ANSTO.

Precision Diagnostics 的營收為 1.158 億美元，成長 3.3%。亮點包括 DEFINITY 的銷售額為 8,390 萬美元，成長 7.5%；同時 TechneLite 的營收為 2,500 萬美元，下降 11.4%，原因是去年同期向 ANSTO 的機會性銷售較多。

Lastly, strategic partnerships and other revenue was $11.6 million, up 32.8% due to the continued contribution from our investigational product candidate. MK-6240, at $6.5 million, as well as $3.4 million from the newly acquired Evergreen CDMO business.

最後，由於我們的研究候選產品的持續貢獻，策略合作夥伴關係和其他收入為 1,160 萬美元，成長 32.8%。MK-6240，價值 650 萬美元，以及來自新收購的 Evergreen CDMO 業務的 340 萬美元。

Gross profit margin for the second quarter was 67.6%, a decrease of 80 basis points. The decrease is mainly attributed to unfavorable pricing impacts to margin, the inclusion of the Evergreen manufacturing infrastructure, offset in part by favorable year-over-year volume from both DEFINITY and PYLARIFY.

第二季毛利率為67.6%，下降80個基點。下降的主要原因是定價對利潤率的不利影響，以及 Evergreen 製造基礎設施的納入，但 DEFINITY 和 PYLARIFY 的同比銷量良好在一定程度上抵消了這一影響。

Operating expenses at 27.2% of net revenue were 227 basis points higher than the prior year rate, but generally in line with previously guided underlying spending levels. As noted in our last earnings call increases in operating expenses reflect investments made to support several growth and efficiency initiatives.

營業費用佔淨收入的 27.2%，比上年高出 227 個基點，但總體上與先前指導的基本支出水準一致。正如我們上次財報電話會議中指出的那樣，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。

Notably, research and development increased 271 basis points to 7.7% of net revenue in support of a number of late and early stage development programs, including, but not limited to, the recent NDA filing for the new PSMA PET product candidate.

值得注意的是，研發支出增加了 271 個基點，達到淨收入的 7.7%，以支援一系列後期和早期開發項目，包括但不限於最近為新的 PSMA PET 產品候選物提交的 NDA。

Operating profit for the quarter was $152.6 million, or a decrease of 10.8%. Other income and expense at $2 million of income is a result of net interest income, offset in part by interest expense on our existing debt. This is slightly less than expected due to the purchase of $100 million of our shares in the quarter.

本季營業利潤為 1.526 億美元，下降 10.8%。其他收入和支出 200 萬美元的收入來自淨利息收入，部分被我們現有債務的利息支出所抵銷。由於本季購買了價值 1 億美元的股票，這一數字略低於預期。

Total adjustments in the quarter were $50.1 million of expense before taxes. Of this amount, $22.3 million and $8 million of expense is associated with non-cash stock and incentive plans and acquired and tangible amortization, respectively.

本季稅前支出總調整額為 5,010 萬美元。其中，2,230 萬美元和 800 萬美元的費用分別與非現金股票和激勵計畫以及收購和有形攤提有關。

Non-recurring expenses tied to closing and integrating our announced acquisitions and investiture, as well as other strategic collaboration costs, totaled $32.9 million, offset in part by an unrealized gain on equity investments of $14.5 million, with the remaining tied to other non-recurring expenses. Our effective tax rate was 28.4%.

與完成和整合我們宣布的收購和投資相關的非經常性費用以及其他策略合作成本總計 3,290 萬美元，部分被 1,450 萬美元的股權投資未實現收益所抵消，其餘部分與其他非經常性費用相關。我們的有效稅率為28.4%。

The resulting reported net income for the second quarter was $78.8 million and $110.6 million on an adjusted basis, a decrease of 12.8%. GAAP fully diluted earnings per share for the second quarter were $1.12 and $1.57 on an adjusted basis, a decrease of 12.8%.

由此得出的第二季淨收入為 7,880 萬美元，調整後為 1.106 億美元，下降 12.8%。第二季 GAAP 完全稀釋每股收益為 1.12 美元，調整後為 1.57 美元，下降 12.8%。

Now turning to cash flow. Second-quarter operating cash flow totaled $87.1 million, up $2.4 million from Q2 last year, as working capital, particularly BPO metrics, have normalized from the post-SAP implementation environment. Included in net income is $7.5 million of non-recurring post-combination expense related to the acceleration and cash settlement of unvested Evergreen stock awards.

現在轉向現金流。第二季營運現金流總計 8,710 萬美元，比去年第二季增加 240 萬美元，因為營運資金（尤其是 BPO 指標）已從 SAP 實施後的環境中恢復正常。淨收入中包括 750 萬美元的非經常性合併後費用，與未歸屬的 Evergreen 股票獎勵的加速和現金結算有關。

Capital expenditures totaled $8 million, $3.2 million lower than the prior year. Free cash flow, which we define as operating cash flow less capital expenditures, was $79.1 million, $5.6 million higher than the prior year period.

資本支出總計 800 萬美元，較前一年減少 320 萬美元。自由現金流（我們將其定義為經營現金流減去資本支出）為 7,910 萬美元，比去年同期高出 560 萬美元。

During the quarter, the company invested $100 million in its own shares at an average price of $79. In addition, the company completed the acquisition of Evergreen, with an additional outlay of approximately $226 million net of cash acquired. And as a reminder, the company prepaid $50 million towards this transaction at the end of the first quarter.

本季度，該公司以平均 79 美元的價格投資了 1 億美元的自有股票。此外，該公司還完成了對 Evergreen 的收購，扣除所獲現金後額外支出約 2.26 億美元。提醒一下，該公司在第一季末為這筆交易預付了 5,000 萬美元。

Taken together, cash and cash equivalents, net of restricted cash, stood at $695.6 million at quarter end and does not reflect the use of funds for the LMI transaction, which closed on July 21. We have access to our $750 million undrawn bank revolver and are comfortable with our strong liquidity position.

總體而言，扣除限制性現金後，現金和現金等價物在季度末達到 6.956 億美元，並未反映 7 月 21 日完成的 LMI 交易的資金使用情況。我們可以使用 7.5 億美元的未提取銀行循環信貸，並且對我們強大的流動性狀況感到滿意。

As such, the company is announcing a $400 million share repurchase authorization with an expiry of 12-31-27, replacing the $50 million remaining on our current repurchase plan, reflective of our conviction that our strategy and execution will create long-term value, including the potential launch of the four new products., including our new PSMA PET diagnostic product candidate.

因此，公司宣布授權回購價值 4 億美元的股票，有效期至 2027 年 12 月 31 日，以取代目前回購計畫中剩餘的 5,000 萬美元，這體現了我們堅信我們的策略和執行將創造長期價值，包括可能推出四種新產品，其中包括我們的新 PSMA PET 診斷候選產品。

Turning now to our updated guidance for the full year 2025. Based on market dynamics, our go forward strategy, and extrapolating out from what we saw in the latter part of Q2 and accounting for anticipated mix of wins and losses, we are adjusting our PYLARIFY range to $940 million to $965 million.

現在來看看我們對 2025 年全年的最新指導。根據市場動態、我們的前進策略，並根據我們在第二季後半段看到的情況進行推斷，並考慮到預期的盈利和虧損組合，我們將 PYLARIFY 範圍調整為 9.4 億美元至 9.65 億美元。

We do not anticipate any changes to other existing products, but for the inclusion of LMI in our forward view, specifically, Neuraceq, which we expect to be in the range of $40 million to $45 million, and $0.04 of EPS contribution for partial Q3 and full Q4 inclusion.

我們預計其他現有產品不會發生任何變化，但將 LMI 納入我們的前瞻性觀點，具體來說，Neuraceq 的價值將在 4000 萬美元至 4500 萬美元之間，部分納入第三季度和全部納入第四季度將貢獻 0.04 美元的 EPS。

Taken together, full-year revenue is now expected to be in the range of $1.475 billion to $1.51 billion from the prior range of $1.55 billion to $1.585 billion. Taking these revenue changes into consideration and the inclusion of LMI, we now see adjusted EPS in the range of $5.50 to $5.70 cents versus the prior guide of $6.60 and $6.50.

總體而言，預計全年營收將在 14.75 億美元至 15.1 億美元之間，而先前的預期為 15.5 億美元至 15.85 億美元。考慮到這些收入變化以及 LMI 的納入，我們現在看到調整後的每股收益在 5.50 美元至 5.70 美元之間，而先前的指導值為 6.60 美元至 6.50 美元。

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

說完這些，讓我把電話轉回給布萊恩。

Thank you, Bob. Before we turn to Q&A, I want to reiterate our steadfast focus on driving commercial execution for PYLARIFY as we continue to position ourselves for growth and sustained radiopharmaceutical leadership.

謝謝你，鮑伯。在我們進入問答環節之前，我想重申我們堅定不移地致力於推動 PYLARIFY 的商業執行，因為我們將繼續為增長和持續的放射性藥物領導地位做好準備。

While we are pleased with our progress in strengthening our capabilities, expanding the portfolio, and enhancing our long-term potential, we fully understand that driving commercial execution is critical to supporting our efforts and remains our top priority.

雖然我們對在加強能力、擴大產品組合和增強長期潛力方面取得的進展感到滿意，但我們完全理解推動商業執行對於支持我們的努力至關重要，並且仍然是我們的首要任務。

We have been taking and will continue to take decisive actions across our commercial business, innovation efforts, and use of capital in both the near and long term that we believe are in the best interest of the business, patients, and shareholders.

我們已經並將繼續在商業業務、創新努力和近期及長期資本使用方面採取果斷行動，我們相信這些行動符合企業、病患和股東的最佳利益。

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

接下來，我將進入問答環節。操作員。

(Operator Instructions) Matt Taylor, Jefferies.

（操作員指示）馬特·泰勒，傑富瑞。

I wanted to ask about your prior comments on 2026. You talked about the acquisitions adding a mid-single-digit CAGR to an underlying growth rate, getting you to consistent double-digit growth. Do you think with the changes that are happening in the market now, you could still achieve that? Or could you offer any thoughts on how to think about 2026 at a high level?

我想問一下您之前對 2026 的評論。您談到收購為基礎成長率增加了中等個位數的複合年增長率，使您實現了持續的兩位數成長。您認為，鑑於目前市場發生的變化，您還能實現這一目標嗎？或者您能否就如何從高層次思考 2026 年提出一些想法？

Yeah, I think it's certainly achievable. But again, I'll let Bob give you the answer in full. But it is a combination of organic and inorganic growth, as we've described before. So Bob?

是的，我認為這肯定是可以實現的。但我還是會讓鮑伯給你完整的答案。但正如我們之前所描述的，它是有機成長和無機成長的結合。那麼鮑伯？

Yeah, I'll build on that. I mean, it is largely predicated on a number of factors that really haven't changed. Putting 2026 for PYLARIFY, there are a lot of moving parts there, but this is a math problem.

是的，我會以此為基礎。我的意思是，它很大程度上取決於許多實際上並未改變的因素。將 PYLARIFY 定為 2026 年，其中有許多變動因素，但這是一個數學問題。

And what I have often talked about is the fact that the keys are having DEFINITY get back to its normal run rate, which is going to be in a high single-digit trajectory. And you're seeing that playing out even in this quarter, which was pretty positive.

我經常談論的是，關鍵是讓 DEFINITY 恢復其正常運行率，即高個位數軌跡。您會看到，即使在本季度，這種情況也表現得相當積極。

But the real keys here are going to be, as Brian noted from an inorganic perspective, the sale of the SPECT business, which removes about $120 million from the base year. And then the real key is what has been -- what we've done and accomplished here with LMI transaction is the annualization of Neuraceq and the growth trajectory that that product has, which has been very positive.

但正如布萊恩從無機角度指出的那樣，這裡真正的關鍵是 SPECT 業務的出售，這將比基準年減少約 1.2 億美元。然後真正的關鍵是 - 我們在 LMI 交易中所做和取得的成就是 Neuraceq 的年化以及該產品的成長軌跡，這是非常積極的。

But supporting that, but to a lesser degree, continues to be the launches of MK-6240, PNT2003, OCTEVY. So while those are more minor in contribution in 2026, just given the time of the year that they would potentially launch, they would still be contributors. But again mathematically, it is still something that's on the table.

但支援這一點的仍然是 MK-6240、PNT2003、OCTEVY 的發射，但程度較輕。因此，儘管這些人在 2026 年的貢獻較小，但考慮到他們可能推出的時間，他們仍然是貢獻者。但從數學角度來看，這仍然是一個有待解決的問題。

Anthony Petrone, Mizuho Americas.

瑞穗美洲公司的安東尼‧佩特羅內 (Anthony Petrone)。

Thanks, and I'll stick with a guidance question, Bob. Maybe just the -- what is actually baked in top and bottom line for LMI? And as we sit here into early August, I think I'm coming up with -- if we add $30 million top line, applied range is minus 4% to minus 6%. PYLARIFY in 2Q is down 8%, so certainly still pressured.

謝謝，我會堅持一個指導性問題，鮑伯。也許只是——LMI 的最高和最低標準是什麼？當我們進入 8 月初時，我想我會想到——如果我們增加 3000 萬美元的頂線，應用範圍是負 4% 到負 6%。PYLARIFY 第二季下跌了 8%，因此肯定仍然面臨壓力。

But maybe if you can give us a sense of -- are there share losses? Is that done at this point? And maybe just a little bit on actually where the underlying market growth rate is at the moment.

但也許您可以讓我們了解一下——是否存在份額損失？到現在為止完成了嗎？也許只是稍微了解一下目前潛在的市場成長率到底是多少。

Yeah. So thanks for the question. I'll let Bob lead off the answer to the beginning of your question, and then Paul will pick up the back half of the question. But I do want to reinforce, we are beginning to see signs of stabilization in the PSMA PET marketplace, which is encouraging. But Bob, go ahead.

是的。感謝您的提問。我會讓鮑伯先回答你問題的開頭，然後保羅繼續回答問題的後半部。但我確實想強調的是，我們開始看到 PSMA PET 市場穩定的跡象，這是令人鼓舞的。但是鮑勃，繼續吧。

Thanks, Anthony. You're right. I mean, the additions of both Evergreen and LMI in terms of Neuraceq are fitting into our goal of continuing to diversify our revenue streams. So specifically, we're forecasting, from an August to December contribution in revenue, $40 million to $45 million of net revenue with $0.04 of EPS accretion.

謝謝，安東尼。你說得對。我的意思是，就 Neuraceq 而言，Evergreen 和 LMI 的加入符合我們繼續實現收入來源多樣化的目標。具體來說，我們預測，從 8 月到 12 月的收入貢獻，淨收入將達到 4,000 萬美元到 4,500 萬美元，每股收益將增加 0.04 美元。

So when you net -- I mean, I had previously talked about the fact that I thought the combination of Evergreen and LMI would be low single-digit dilution. And that is actually what we're seeing.

因此，當你進行淨額計算時——我的意思是，我之前曾談到我認為 Evergreen 和 LMI 的組合將是低個位數稀釋的事實。這實際上就是我們所看到的。

We do have two different contribution periods in terms of Evergreen being nine months, and we've got five months of LMI. If I normalize that, we certainly get down into that low single-digit dilution perspective. So we're right on pace for that part of the contribution.

我們確實有兩個不同的繳費期，其中 Evergreen 為九個月，LMI 為五個月。如果我將其標準化，我們肯定會陷入低個位數稀釋的視角。因此，我們在這方面的貢獻步伐是正確的。

For the PYLARIFY question, I'll turn it to Paul.

對於 PYLARIFY 問題，我將把它交給 Paul。

Thanks, Bob. Thanks, Anthony. So our assumptions for the second half for PYLARIFY are that we continue to grow volumes year over year in the low single-digit range, which was largely consistent with what we saw in the first half of the year.

謝謝，鮑伯。謝謝，安東尼。因此，我們對 PYLARIFY 下半年的假設是，我們的交易量將繼續以較低的個位數同比增長，這與我們上半年看到的情況基本一致。

The broader market will continue to grow in the mid- to high teens in the second half of the year year over year. So that does factor in some continued share loss driven by our over-indexing to larger institutions and recognizing some of the competitive dynamics in the marketplace.

今年下半年，大盤將繼續維持年比中高水準的成長。因此，這確實考慮到了由於我們對大型機構的過度關注以及認識到市場上的一些競爭動態而導致的一些持續的份額損失。

Notably, we expect net price to continue to decline sequentially in both the third and the fourth quarter for PYLARIFY. This is due to the pricing actions in both renegotiations that took place in the second quarter in the back half that will then fully quarterize, if you will, for the third quarter as well as in the fourth quarter.

值得注意的是，我們預計 PYLARIFY 的淨價將在第三季和第四季將繼續連續下降。這是由於在下半年第二季度進行的兩次重新談判中的定價行動，如果願意的話，這些行動將在第三季和第四季完全實現季度化。

And then we also expect to see some impact on best price or 340B. That's a two-quarter lag from a government pricing perspective. And so volumes for PYLARIFY will continue to grow as they have in the first half of this year, but we will see that left on the market. And we will see further price degradation, given some of the competitive dynamics. And those are the underlying assumptions baked within our guide.

然後我們也希望看到對最佳價格或 340B 的一些影響。從政府定價的角度來看，這是一個兩季的滯後。因此，PYLARIFY 的銷售將像今年上半年一樣繼續成長，但我們會看到其留在市場上。考慮到一些競爭動態，我們將看到價格進一步下降。這些就是我們指南中的基本假設。

Richard Newitter, Truist Securities.

Truist Securities 的 Richard Newitter。

Maybe just on the new formulary for PYLARIFY. I guess, what's the earliest that you could potentially be commercial with a product like this from a timing standpoint with a, I guess, March 6 PDUFA? So is it possible you could have this by mid-year, TPT in place? Or is it more likely in the October timeframe of next year?

也許只是關於 PYLARIFY 的新處方集。我想，從時間角度來看，最早什麼時候可以將這樣的產品投入商業化，我想是 3 月 6 日的 PDUFA？那麼，您有可能在年中之前完成 TPT 嗎？或者更有可能是在明年十月左右？

And then just on that next-gen PYLARIFY product, I'm just curious if you could talk a little bit about -- why couldn't this have been put out earlier? I guess it feels a little reactionary, but I'm just curious on how the strategy there took form and when that began.

然後就下一代 PYLARIFY 產品而言，我很好奇您是否可以談談——為什麼不能早點推出它？我想這聽起來有點反動，但我只是好奇那裡的策略是如何形成的以及何時開始的。

Yeah, Rich, and I appreciate the questions. And I'll take the why now part of it, flip it over to Paul for a little more detail. But I think the way you've discussed the PDUFA date and potential approval and HCPCS codes, I think you're pretty much spot on. But I'll let Paul review it one more time.

是的，Rich，我很感謝你的提問。我將討論為什麼現在要這樣做，並將其交給保羅以了解更多細節。但我認為您討論 PDUFA 日期和潛在批准以及 HCPCS 代碼的方式非常正確。但我會讓保羅再審查一次。

As far as the why now is concerned, research and development is never on a stopwatch the way you'd like it to be. And while we have said repeatedly that we have a lot of work in development, we wanted to make sure that we really got it right and had a new formulation that would actually work in the marketplace and actually be worth our time and energy and have rewards and payout for the customers.

就現在的原因而言，研究和開發從來都不是像你希望的那樣在秒錶上進行的。雖然我們一再表示，我們在開發方面還有很多工作要做，但我們希望確保我們確實做對了，並且有一個真正在市場上發揮作用的新配方，真正值得我們投入時間和精力，並為客戶帶來回報和回報。

And I think the improvement in batch yield; improvement in our ability to, if you will, load the formulation for greater out-the-door time, greater convenience, all makes it work extremely well. And also, there's a gross margin benefit that we will accrue here as well, which is pretty meaningful.

我認為批量產量的提高；以及我們裝載配方能力的提高，以便延長出廠時間，提高便利性，所有這些都使得它運行得非常好。此外，我們還將獲得毛利率收益，這是非常有意義的。

So our research and development in large part has some serendipity involved. So I'd like it to be available sooner, but it's available, i think, at the right time for us. So Paul, a little bit on timing.

因此，我們的研究和開發很大程度上都與偶然性有關。所以我希望它能盡快上市，但我認為，對我們來說，現在上市的時間已經合適了。保羅，稍微談談時間安排。

Yeah. Thanks, Brian. Thanks, Rich. So as was mentioned, we're going to work expeditiously to activate our supply chain; to secure coding coverage and payment, including HCPCS and TPT. We're going to share more exact timing as we get closer to launch.

是的。謝謝，布萊恩。謝謝，里奇。如同所提及的，我們將迅速啟動我們的供應鏈；確保編碼覆蓋和付款，包括 HCPCS 和 TPT。隨著發布的臨近，我們將分享更準確的時間。

But effectively, with a March 2026 PDUFA date, we would expect to be able to potentially meet the June 1 submission for TPT, which would then go live in the fall, October 1. At the latest we would imagine January 1.

但實際上，根據 2026 年 3 月的 PDUFA 日期，我們預計能夠滿足 6 月 1 日的 TPT 提交要求，該要求將於秋季（10 月 1 日）生效。我們想像最晚是 1 月 1 日。

But there is some sequencing in order to get our PMF chains activated and approved to be able to go forward with this new formulation, which, as Brian mentioned, we think will provide a number of benefits, including batch size, including production efficiency, and most importantly, leveling the playing field with regard to TPT reimbursement and then ultimately ensuring that clinical differentiation is recognized and is appreciated by customers and wins the day and overcomes some of the transitory reimbursement-related inequities in the market.

但是，為了激活和批准我們的 PMF 鏈，以便能夠繼續推進這一新配方，需要進行一些排序，正如 Brian 提到的，我們認為這將帶來許多好處，包括批量大小、生產效率，最重要的是，在 TPT 報銷方面創造公平的競爭環境，最終確保臨床差異化得到客戶的認可和讚賞，贏得勝利，並克服市場上一些與報銷相關的暫時認可。

Yuan Zhi, B. Riley.

袁志，B.萊利。

Maybe Brian or Paul, how should we think about this new formulation, whether it will have an impact on your long-term contracts already in place? Will it be an add-on to the contract or will it trigger another negotiation of those contracts?

也許 Brian 或 Paul，我們應該如何看待這個新提法，它是否會對你們已經簽訂的長期合約產生影響？它會成為合約的附加條款還是會引發對這些合約的另一次談判？

Well, it's very simple. It'll be a complete add-on. It's already contemplated in our contract language and could potentially offer the opportunity for a 340B price reset, which would be very helpful and meaningful to the franchise and to the marketplace. So the contracts already contemplate this. Appreciate the question, and we're ready to roll.

嗯，很簡單。它將是一個完整的附加元件。我們的合約語言中已經考慮到了這一點，並且可能提供 340B 價格重置的機會，這對於特許經營權和市場來說非常有幫助且有意義。所以合約已經考慮到了這一點。感謝您的提問，我們已準備好開始。

Mazi Alimohamed, Leerink.

Mazi Alimohamed，Leerink。

Thanks. This is Mazi on for Roanna. So can you provide more details on the commercial opportunity for tau imaging and how this fits with the broader Alzheimer's strategy alongside Neuraceq?

謝謝。這是 Mazi 為 Roanna 表演的。那麼，您能否提供有關 tau 成像的商業機會的更多細節，以及它如何與 Neuraceq 一起適應更廣泛的阿茲海默症策略？

Yeah, I think it's a terrific question. Coming out of the meeting, the AAIC in Toronto a few weeks ago, there are a number of important agents in late-stage development that, quite frankly, already use MK-6240 for patient selection and longitudinal follow-ups.

是的，我認為這是一個非常好的問題。幾週前在多倫多舉行的 AAIC 會議上，有許多重要的藥物處於後期開發階段，坦白說，它們已經在使用 MK-6240 進行患者選擇和縱向追蹤。

So while today, there's not a huge demand for tau tracers, going forward, the value that a tau tracer brings to the marketplace is really going to be quite unmistakable. The ability to pinpoint more precisely the cause of sequelae of Alzheimer's dementia, longitudinal follow-up, and also the potential for improvement with therapy is an unmistakable benefit of a tau tracer.

因此，儘管目前對 tau 示蹤劑的需求並不大，但展望未來，tau 示蹤劑為市場帶來的價值將非常明顯。能夠更準確地查明阿茲海默症癡呆症後遺症的原因、縱向追蹤以及透過治療改善的潛力是 tau 示蹤劑的明顯優勢。

So we're excited about it. It's a building market. It doesn't really blow up and become enormous tomorrow, but it certainly has what we believe is potential across our neuro portfolio to be similar in size as PYLARIFY.

所以我們對此感到很興奮。這是一個建築市場。它不會真的在明天就爆發並變得巨大，但我們相信它在我們的神經產品組合中確實有潛力達到與 PYLARIFY 類似的規模。

And maybe I'll just add to everything Brian mentioned. I think as we start to work more closely with our newly welcomed LMI colleagues, I think we're incredibly pleased with the capabilities and the talent of our LMI neuro team, which serves as an existing commercial franchise that will be able to further highlight the clinical differentiation that we believe MK and, indeed, Neuraceq in our late stage pipeline.

也許我會補充 Brian 提到的所有內容。我認為，當我們開始與新加入的 LMI 同事更緊密地合作時，我們對 LMI 神經團隊的能力和才華感到非常滿意，該團隊作為現有的商業特許經營權，將能夠進一步突出我們相信 MK 和 Neuraceq 在我們後期管道中的臨床差異化。

And so we're excited to build on that scale and those talents and capabilities that have recently joined our organization to be a preeminent leader in the neuro PET diagnostic market like we have been in PSMA.

因此，我們很高興能夠在這樣的規模以及最近加入我們組織的人才和能力的基礎上，成為神經 PET 診斷市場的卓越領導者，就像我們在 PSMA 中一樣。

Larry Solow, CJS Securities.

索洛（Larry Solow），CJS 證券公司。

Can you just give us an idea of how much of your business on PYLARIFY specifically is contracted versus non-contracted? Maybe just fade into that, I imagine obviously that's been continuing to rise.

您能否具體告訴我們，您在 PYLARIFY 上的業務中，有多少是合約業務，有多少是非合約業務？也許只是逐漸消失，我想顯然這種情況一直持續上升。

And then the second part of that question is. On these contracts themselves, you mentioned some. Renegotiation. So did you lose some share of these strategic agreements -- from strategic agreements? So I'm just trying to get a little more hold of -- grasp on how firm are these agreements because it sounds like you've walked away from, maybe in some cases, some contracted business as well, if I'm hearing that correctly.

然後這個問題的第二部分是。關於這些合約本身，您提到了一些。重新談判。那麼，您是否從這些戰略協議中失去了一些份額？因此，我只是想更多地了解這些協議的強度，因為如果我沒聽錯的話，這聽起來好像你已經放棄了，也許在某些情況下，也放棄了一些合約業務。

And again, I appreciate the question. We have not given specific counts, if you will, or percentages, but the vast majority of our business is under contract. And I think one of the things that has evolved with the change to MUC reimbursement is some of our accounts had much greater exposure, if you will, to the MUC reimbursement dynamic than the classic 20% that would normally be across the board exposed to this through traditional Medicare.

我再次感謝你提出這個問題。如果您願意的話，我們沒有給出具體的數量或百分比，但我們的絕大多數業務都是根據合約進行的。我認為，隨著 MUC 報銷制度的變化，我們的一些帳戶受到 MUC 報銷動態的影響比傳統醫療保險普遍受到的 20% 影響更大。

And with those accounts, if they're especially price sensitive, the negotiation gives us basically a last look. And we have decided it's not in our best interest. Really, we don't think it's in their best interest for their patients. But we have decided to walk away from a discounting dynamic that was more than we're willing to tolerate.

對於這些客戶，如果他們對價格特別敏感，談判基本上會讓我們最後一次檢視。我們認為這不符合我們的最佳利益。確實，我們認為這不符合他們病患的最佳利益。但我們已決定放棄超出我們所能容忍的折扣行為。

So Paul, I think you want to build on that.

所以保羅，我認為你想以此為基礎。

Yeah. Thanks, Brian, and thanks for the question there, Larry. The strategic partnerships have been successful on a number of fronts, as we've shared. They enabled us to maintain and grow volumes in our core business, to have significantly higher market share in those accounts than we do in those small number of accounts that are not contracted, though we are increasingly coexisting with gallium.

是的。謝謝，布萊恩，也謝謝你提出的問題，拉里。正如我們所分享的，戰略夥伴關係在許多方面都取得了成功。它們使我們能夠維持和增加核心業務的銷量，使我們在這些帳戶中的市場份額明顯高於那些未簽約的少數帳戶，儘管我們越來越多地與鎵共存。

They were designed and largely leveled the playing field related to the MUC-based reimbursement dynamics at hospitals. What we particularly saw in the quarter is that one of our competitors, an F-18-based competitor, significantly increased aggressive pricing that was greater and broader than was anticipated.

它們的設計和實施在很大程度上平衡了醫院基於 MUC 的報銷動態的競爭環境。我們在本季特別看到的是，我們的一個競爭對手，一家基於 F-18 的競爭對手，大幅提高了激進的定價，其幅度和範圍都超出了預期。

And so when we look at our strategic partnerships, when we have the MUC-based reimbursement dynamics that they were largely designed to level the playing field, when we add the pricing dynamics and offers, that put some customers in a position to have to come back to us to relook at the terms of those contracts.

因此，當我們審視我們的策略合作夥伴關係時，當我們擁有基於 MUC 的報銷動態時，它們主要是為了公平競爭而設計的，當我們添加定價動態和優惠時，這會讓一些客戶不得不回到我們身邊重新審視這些合約的條款。

In some cases, it made sense economically for the long-term health of the franchise to renegotiate those contracts to maintain the business and those core customers. In others, given some of the best price dynamics, it did not make sense. And so we made the difficult decision in some cases to walk away from volumes to not honor -- to not increase our pricing terms such that we could inadvertently materially impact the long-term health of the business. And those are some of the dynamics.

在某些情況下，重新協商這些合約以維持業務和核心客戶對於特許經營的長期健康發展具有經濟意義。在其他情況下，考慮到一些最佳價格動態，這沒有任何意義。因此，在某些情況下，我們做出了艱難的決定，放棄不履行的訂單量——不提高我們的定價條款，因為我們可能會無意中對業務的長期健康產生重大影響。這些就是一些動態。

We have conducted a bottoms-up review of all of our contracts, Brian, myself, and our commercial team. We have proactively reached out to customers. We do believe there is stabilization emerging in the marketplace, and that those will prove continued value-added for the long-term health of the business.

我們對所有合約、布萊恩、我自己以及我們的商業團隊進行了自下而上的審查。我們已經主動聯絡客戶。我們確實相信市場正在趨於穩定，並且這將為企業的長期健康持續增加價值。

Justin Walsh, Ph.D., Jones Trading.

賈斯汀·沃爾什 (Justin Walsh) 博士，瓊斯貿易公司。

You mentioned the TPT reset you're hoping to see with the new formulation. Can you comment on the most recent updates for the TPT timelines for key competitors? If you expect these competitors to maybe make similar moves, then how confident you are that the new formulation will be awarded TPT?

您提到了希望透過新配方實現 TPT 重置。您能否評論一下主要競爭對手的 TPT 時間表的最新更新？如果您預計這些競爭對手可能會採取類似的舉措，那麼您對新配方獲得 TPT 有多大信心？

All right. I'll start the answer. I'll then flip it to Paul. We're very confident. Given the fact that this is a NDA application, we've had an extensive review with our internal and external experts and feel highly confident that this formulation, should it be approved, will be eligible for new HCPCS codes and reimbursement.

好的。我先開始回答。然後我會把它翻給保羅。我們非常有信心。鑑於這是一份 NDA 申請，我們與內部和外部專家進行了廣泛的審查，並且非常有信心，如果該配方獲得批准，它將有資格獲得新的 HCPCS 代碼和報銷。

So Paul?

那麼保羅？

Yeah, Justin. Maybe just get into some of the specifics. I agree with Brian and our overall confidence on our new formulation being eligible for a HCPCS code and for TPT.

是的，賈斯汀。也許只是了解一些細節。我同意 Brian 的觀點，我們對我們的新配方符合 HCPCS 代碼和 TPT 的整體信心。

If we look at the broader marketplace, our primary gallium competitor lost TPT on their product on July 1 of this year. Now, they do have another agent in development that they have been discussing, and they presumably plan for TPT later this year. But I'll leave that up to them to comment.

如果我們看一下更廣闊的市場，我們的主要鎵競爭對手在今年 7 月 1 日失去了其產品的 TPT。現在，他們確實正在討論開發另一種藥物，並且他們大概計劃在今年稍後推出 TPT。但我會讓他們自己評論。

Our number one F-18-based competitor would lose TPT as of October 1, 2026. And so those are the latest timelines. And as I shared earlier, I believe in my response to Rich, we would expect potential TPT for our new formulation in the same time frame as our F-18 competitor were to lose it. As for their internal development plans, I will leave that up to them to answer.

我們的頭號 F-18 競爭對手將於 2026 年 10 月 1 日失去 TPT。這些就是最新的時間表。正如我之前分享的，我相信在我對 Rich 的回覆中，我們預計我們的新配方的潛在 TPT 將與我們的 F-18 競爭對手在同一時間範圍內失去它。至於他們的內部發展計劃，我將留給他們自己去回答。

Tara Bancroft, TD Securities.

塔拉·班克羅夫特（Tara Bancroft），道明證券。

Hi. This is Frances on for Tara Bancroft. So for the new PSMA imaging agent, how are you seeking to position versus PYLARIFY and what are your pricing assumptions with several new entrants? Do you expect to offer substantial discounts for this versus PYLARIFY to gain traction?

你好。這是弗朗西斯 (Frances) 為塔拉·班克羅夫特 (Tara Bancroft) 主持的節目。那麼，對於新的 PSMA 成像劑，您如何定位與 PYLARIFY 相比，您對幾個新進入者的定價假設是什麼？您是否希望透過提供相對於 PYLARIFY 的大幅折扣來獲得關注？

I think we are very excited about the new formulation. We are expeditiously working to prepare our launch plans, to continue to engage with the agency, and to meet our March 6, 2026, PDUFA date. I think overall, we believe this will allow us to improve the pricing dynamics in the marketplace, driven by a number of fronts.

我認為我們對新配方感到非常興奮。我們正在加緊制定發布計劃，繼續與該機構合作，以滿足 2026 年 3 月 6 日的 PDUFA 日期。我認為總體而言，我們相信這將使我們能夠在多個方面的推動下改善市場定價動態。

One, the reset of 340B best price in the marketplace, given the two-quarter, six-month lag from a government price reporting dynamic. I think secondly, when we look at our new formulation being on a three-year TPT dynamic, we think some of the strategic partnerships, while remaining critical, also pose an opportunity, recognizing there would be more of a reimbursement-level playing field in the marketplace than the current disadvantage that PYLARIFY has.

一是，鑑於政府價格報告動態存在兩季、六個月的滯後，重新設定 340B 市場最佳價格。我認為其次，當我們審視我們基於三年期 TPT 動態的新配方時，我們認為一些戰略合作夥伴關係雖然仍然至關重要，但也帶來了機遇，認識到市場上將有比 PYLARIFY 目前面臨的劣勢更多的報銷公平競爭環境。

And so we feel incredibly optimistic and positive that, first, it will level the playing field; and secondly, it will enable us to focus on the continued clinical differentiation of the agent, which is still very much understood and is increasingly emerging in the marketplace as competitors experience other F-18 agents and see some of the downsides in those agents, but unfortunately, given some of the MUC-based reimbursement dynamics are providing a temporal challenge that we believe our new formulation will help address.

因此，我們感到非常樂觀和積極，首先，它將創造公平的競爭環境；其次，它將使我們能夠專注於藥物的持續臨床差異化，這種藥物仍然非常容易理解，並且隨著競爭對手體驗其他 F-18 藥物並看到這些藥物的一些缺點，這種藥物在市場上日益湧現，但不幸的是，鑑於一些基於 MUC 的報銷結果，我們將有助於暫時解決這一動態的挑戰，有助於我們相信這一動態的挑戰。

Kemp Dolliver, Brookline Capital Markets.

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

Looking farther out into 2027, given that we will not have ASP into 2026, if we get ASP in 2027, how are you thinking about the impact of that on your strategy, given you're going to have two products -- essentially two versions of PYLARIFY in the marketplace, presumably with different reimbursement dynamics?

展望 2027 年，考慮到我們在 2026 年不會有 ASP，如果我們在 2027 年獲得 ASP，您如何看待這對您的策略的影響，因為您將有兩種產品 - 基本上是市場上兩種版本的 PYLARIFY，大概具有不同的報銷動態？

Yeah. Appreciate the question. We move to ASP. Let's presume it's the beginning of. 2027. It's perfectly in line with our strategy. The new formulation will replace the older, will have an improvement in gross margin, and again, the potential for a 340B price reset. And our current contracts or partnerships already contemplate the ability to add portfolio products to their agreements.

是的。感謝你的提問。我們轉向 ASP。我們假設這是…的開始。2027年。這完全符合我們的策略。新配方將取代舊配方，提高毛利率，並有可能重新設定 340B 的價格。我們目前的合約或合作夥伴關係已經考慮將投資組合產品添加到他們的協議中。

John Vandermosten, Zacks.

約翰·范德莫斯滕，Zacks。

Another question on the new formulation of PYLARIFY. How much expansion in market size do you think the new formulation of PYLARIFY will get? And then will the new formulation completely replace the existing PYLARIFY? I think you may have said that, Brian, but I just wanted to clarify how you expect that to change over time, that mix between the new and the old.

關於 PYLARIFY 新配方的另一個問題。您認為 PYLARIFY 的新配方將獲得多大的市場規模擴張？那麼新配方會完全取代現有的PYLARIFY嗎？我想你可能已經這麼說過，布萊恩，但我只是想澄清一下，你認為隨著時間的推移，新舊事物的混合將如何變化。

John, thanks for the question. We expect the new formulation to completely replace PYLARIFY as it currently exists in the marketplace. And as far as expanding the market, I think with a level playing field and what we believe is the best PSMA agent, we think we'll be able to return to growth.

約翰，謝謝你的提問。我們預計新配方將完全取代目前市場上的 PYLARIFY。至於擴大市場，我認為，在公平的競爭環境下，以及我們認為最好的 PSMA 代理商下，我們將能夠恢復成長。

And certainly, the customers that I'm talking to right now that are seeing poor performance with the other F-18 agents, I anticipate that they're going to come back to us. We will also have expanded out the door times and the ability to deliver across a wider radius with the newer formulation. So I'm very much looking forward to the launch of that product, and it's a key part of our future strategy.

當然，我現在正在與之交談的客戶發現其他 F-18 代理商的表現不佳，我預計他們會回到我們這裡。我們也將透過更新的配方延長送貨上門的時間，並提高送貨範圍更廣的能力。所以我非常期待該產品的推出，它是我們未來策略的關鍵部分。

Andy Hsieh, William Blair.

安迪謝、威廉布萊爾。

Just going back to the AAIC conference. I guess one of the themes that came out is using blood-based biomarkers as a rule-out test specifically for the symptomatic patients. I believe you highlighted your Alzheimer's sensitivity across different product portfolios.

剛剛回到 AAIC 會議。我猜其中一個主題是使用基於血液的生物標記作為專門針對有症狀患者的排除測試。我相信您在不同的產品組合中強調了您對阿茲海默症的敏感度。

I'm just curious about your strategy in boosting the utility in the prodramal patient population so you can expand beyond just screening for the high risk patients in that setting.

我只是好奇您在提高前兆患者群體效用的策略，以便您可以擴展到不僅僅篩選該環境中的高風險患者。

Great question, and I appreciate it. I think we're really looking at the blood-based biomarkers as a market expansion opportunity and a way for primary care to basically almost view it like it's a PSA test for prostate cancer and get patients to the neurologist and then let the neurologist make the decision upon a full workup for an amyloid or a tau scan or both.

這個問題問得非常好，我很感激。我認為我們確實將血液生物標記視為一個市場擴張機會，也是一種讓初級保健基本上將其視為前列腺癌 PSA 測試的方式，讓患者去看神經科醫生，然後讓神經科醫生根據澱粉樣蛋白或 tau 掃描或兩者的全面檢查來做出決定。

I think the game going forward is all about identifying these patients much earlier in their treatment paradigm or the disease course. And I think if you look at our tracers, particularly MK and NAV and, further in the pipeline, 2620, they are definitely more sensitive and have better spatial resolution than the current first generation traces available.

我認為未來的遊戲重點在於在治療模式或疾病過程中更早地識別這些患者。我認為，如果你看一下我們的示踪劑，特別是 MK 和 NAV，以及正在研發的 2620，它們肯定比目前可用的第一代示踪劑更靈敏，並且具有更好的空間分辨率。

So we're very much looking forward to future therapeutics that seem to be on the near term horizon and could be a step up over what's currently available.

因此，我們非常期待在不久的將來出現的治療方法，並且可能比現有的治療方法更進一步。

Yuan Zhi, B. Riley.

袁志，B.萊利。

Maybe one follow up question to Bob or Paul on Neuraceq. What's the underlying assumption of year-over-year growth in both volume and price for your $40 million revenue guidance in 2025 for the last five months?

也許可以向鮑伯或保羅詢問有關 Neuraceq 的一個後續問題。過去五個月，您預測 2025 年營收將達到 4,000 萬美元，而銷售量和價格年增率的基本假設是什麼？

We're not going to be able to disclose the year-to-date Neuraceq performance as it is still within another public company, albeit a South African listed company. So from that perspective, I think what I can tell you is that the growth trajectory, what represents these last four months, represents a very healthy double digit growth rate, if you will, overall, for Neuraceq.

我們無法揭露今年迄今為止 Neuraceq 的業績，因為它仍然在另一家上市公司旗下，儘管這是一家南非上市公司。因此，從這個角度來看，我認為我可以告訴你的是，過去四個月的成長軌跡代表了 Neuraceq 整體上非常健康的兩位數成長率。

Right now, we're just busy integrating and getting plans. Paul, if you want to expand on the efforts from a US sales trajectory.

現在，我們正忙於整合和製定計劃。保羅，如果你想從美國銷售軌跡的角度進一步闡述你的努力。

Yeah, absolutely. I mean, I think we're -- thanks for the question, Yuan. We're very excited about Neuraceq. We think that the growth will continue to be driven by a growing overall PET diagnostic market for Alzheimer's, led by increased patient and customer awareness and the continued adoption of therapeutic agents, both those that are on the market and the excitement in the long term about the late stage pipelines.

是的，絕對是如此。我的意思是，我認為我們──謝謝你的提問，袁。我們對 Neuraceq 感到非常興奮。我們認為，阿茲海默症 PET 診斷市場的整體成長將繼續推動這一成長，這得益於患者和客戶意識的提高以及治療藥物的持續採用，包括市場上現有的治療藥物和對後期研發管線的長期興奮。

We are incredibly pleased with the team that's joining us from LMI, and we believe that our combined organizations will enable greater supply and geographic expansion from a PNF network, levering the expertise we've built with PYLARIFY, deeper customer relationships driven by our broader portfolio, and then improve systems and processes.

我們對來自 LMI 的團隊的加入感到非常高興，我們相信，合併後的組織將透過 PNF 網路實現更大的供應和地理擴展，利用我們透過 PYLARIFY 建立的專業知識、透過我們更廣泛的產品組合推動的更深層次的客戶關係，然後改進系統和流程。

And we believe, as I mentioned earlier, that the Alzheimer's commercial franchise that the LMI team has so built with incredible talent and capabilities, it's going to serve as a great launching pad as we think about MK-6240 and our own combined late stage Alzheimer's portfolio.

正如我之前提到的，我們相信，LMI 團隊憑藉其令人難以置信的天賦和能力所建立的阿茲海默症商業特許經營權，在我們考慮 MK-6240 和我們自己的後期阿茲海默症產品組合時，將成為一個很好的發射台。

David Turkaly, Citizens.

大衛‧圖卡利（David Turkaly），《公民報》。

One for Bob quickly here. So I just wanted to check some math. So given the guidance for PYLARIFY implied in the back half of the year, if we look at that as a base point for 2026 and we assume a little volume growth off how you exit this year, would it be fair to look at PYLARIFY revenues in '26 and say they could be flattish to possibly even down a little bit versus '25, given what we're seeing today?

這裡快速給鮑勃一個。所以我只是想檢查一些數學。因此，考慮到 PYLARIFY 在下半年隱含的指導，如果我們將其視為 2026 年的基點，並假設今年的退出會帶來少量銷量增長，那麼根據我們今天看到的情況，我們可以公平地看待 26 年 PYLARIFY 的收入，並說它們可能與 25 年持平甚至可能略有下降？

I don't think that's an unfair assumption. Obviously, we're not here to provide guidance on 2026. Your math and your thinking around somewhat of the trajectory in terms of annualizing through the pricing dynamics that we've seen here and what we're expecting in the second half of the year.

我認為這不是一個不公平的假設。顯然，我們並不是來為 2026 年提供指導的。您的數學計算和思考圍繞著我們在這裡看到的定價動態的年度化軌跡以及我們對下半年的預期。

I do think that we will annualize through those as we go through the first half of next year. So what we've seen obviously does expand out that annualization process. So again, your assumptions are not wrong in totality.

我確實認為，到明年上半年，我們將透過這些來實現年度化。因此，我們所看到的顯然確實擴大了年度化。所以，再說一次，你的假設總體上並沒有錯。

David, I would just add to Bob. Agree with everything he said. We want to be really clear. Our top priority. Is to stabilize PYLARIFY to maintain market leadership in 2025 and ensure that we set up our PSMA PET franchise for long-term growth leadership and success. And so we'll certainly come to '26 when it's appropriate, but that remains our clear focus as an organization.

大衛，我只想補充鮑伯。同意他所說的一切。我們想要說得非常清楚。我們的首要任務。是為了穩定 PYLARIFY 以保持 2025 年的市場領導地位，並確保我們建立 PSMA PET 特許經營權，以實現長期成長領導地位和成功。因此，我們肯定會在適當的時候進入 26 強，但這仍然是我們作為一個組織的明確重點。

Richard Newitter, Truist Securities.

Truist Securities 的 Richard Newitter。

Just on that last answer to David's question. I guess when you said that double-digit growth combined inorganic and organic in 2026 is still the goal or on the table, it sounds like you're assuming the possibility that that's achievable with negative PYLARIFY growth, as you just said. Is that correct?

僅針對大衛問題的最後一個答案。我想，當您說 2026 年無機和有機增長的兩位數增長仍然是目標或可行時，聽起來您假設透過負 PYLARIFY 增長可以實現這一目標，正如您剛才所說的那樣。對嗎？

Yes. Thank you, operator.

是的。謝謝您，接線生。

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.

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。