Organon & Co (OGN) 2025 Q2 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Hello, and welcome to the Organon second quarter 2025 earnings call and webcast. (Operator Instructions)

    您好,歡迎參加 Organon 2025 年第二季財報電話會議及網路廣播。(操作員指示)

  • I would now like to turn the conference over to Jennifer Halchak, Vice President, Investor Relations. You may begin.

    現在,我想將會議交給投資者關係副總裁 Jennifer Halchak。你可以開始了。

  • Jennifer Halchak - Vice President, Head of Investor Relations

    Jennifer Halchak - Vice President, Head of Investor Relations

  • Thank you, operator, and good morning, everyone. Thank you for joining Organon's second quarter earnings call. With me today are Kevin Ali, Organon's Chief Executive Officer; and Matt Walsh, our Chief Financial Officer; Juan Camilo Ferreira, Organon's Head of R&D, will also be joining for the Q&A portion of this call.

    謝謝接線員,大家早安。感謝您參加 Organon 的第二季財報電話會議。今天與我一起參加會議的還有 Organon 執行長 Kevin Ali 和財務長 Matt Walsh;Organon 研發主管 Juan Camilo Ferreira 也將參加本次電話會議的問答環節。

  • Today, we will be referencing a presentation that will be visible during this call for those of you on our webcast. This presentation will also be available following this call on the Events and Presentations section of our Organon Investor Relations website at www.organon.com. Before we begin, I would like to caution listeners that certain information discussed by management during this conference call will include forward-looking statements.

    今天,我們將在本次電話會議期間為網路廣播中的各位觀眾提供一份簡報。本次電話會議結束後,您也可以在 Organon 投資者關係網站 www.organon.com 的「活動和簡報」部分查看此簡報。在開始之前,我想提醒各位聽眾,管理階層在本次電話會議中討論的某些資訊可能包含前瞻性陳述。

  • Actual results could differ materially from those stated or implied by forward-looking statements due to risks and uncertainties associated with the company's business, which are discussed in the company's filings with the Securities and Exchange Committee, including our 10-K and subsequent periodic filings.

    由於公司業務存在風險和不確定性,實際結果可能與前瞻性陳述中明示或暗示的結果存在重大差異,這些風險和不確定性在公司向美國證券交易委員會提交的文件中進行了討論,包括我們的 10-K 報告和後續定期文件。

  • In addition, we will discuss certain non-GAAP financial measures on this call, which should be considered a supplement to and not a substitute for financial measures prepared in accordance with GAAP. A A reconciliation of these non-GAAP measures to the comparable GAAP measures is included in the press release and conference call presentation.

    此外,我們將在本次電話會議上討論某些非 GAAP 財務指標,這些指標應被視為依照 GAAP 編制的財務指標的補充,而不是替代方案。新聞稿和電話會議介紹中包含了這些非 GAAP 指標與可比較 GAAP 指標的對帳。

  • I would now like to turn the call over to our CEO, Kevin Ali.

    現在我想將電話轉給我們的執行長凱文·阿里 (Kevin Ali)。

  • Kevin Ali - Chief Executive Officer, Director

    Kevin Ali - Chief Executive Officer, Director

  • Good morning, everyone, and thank you, Jen. Revenue for the second quarter was $1.6 billion, down 1% at constant currency with our growth pillars and contributions from new assets, mostly offsetting the loss of exclusivity of Atozet in the EU. Given year-to-date operational performance and our current view of movements in various foreign currencies, we are raising our revenue guidance range by $100 million at the midpoint. Additionally, we generated strong adjusted EBITDA this quarter of $522 million representing a 32.7% margin.

    大家早安,謝謝你,Jen。第二季營收為 16 億美元,以固定匯率計算下降 1%,這主要得益於我們的成長支柱和新資產的貢獻,基本上抵消了 Atozet 在歐盟失去獨家經營權的影響。鑑於今年迄今的營運表現以及我們目前對各種外幣走勢的看法,我們將營收預期範圍中位數上調 1 億美元。此外,本季我們實現了強勁的調整後 EBITDA,達到 5.22 億美元,利潤率為 32.7%。

  • Year-to-date, our adjusted EBITDA is $1 billion or a 32.4% margin. Strength year-to-date was primarily due to favorability in adjusted gross margin, investment prioritization behind our growth pillars and the realization of savings from our restructuring programs to become a more fit-for-purpose organization.

    年初至今,我們的調整後 EBITDA 為 10 億美元,利潤率為 32.4%。今年迄今為止的強勁表現主要歸功於調整後的毛利率良好、對成長支柱的投資優先考慮以及透過重組計劃實現的節約,從而使我們成為一個更適合目標的組織。

  • As a result, we are affirming our adjusted EBITDA margin guidance range of 31% to 32%. A strong focus on EBITDA generation underpins our objectives to deliver more than $900 million of free cash flow before onetime costs in 2025.

    因此,我們確認調整後的 EBITDA 利潤率指引範圍為 31% 至 32%。我們高度重視 EBITDA 的產生,這為我們實現以下目標奠定了基礎:在 2025 年一次性成本之前實現超過 9 億美元的自由現金流。

  • Year-to-date, we're tracking well against that goal. As we signaled to you last quarter, we are committed to reducing our debt burden. To that end, in the second quarter, we repaid approximately $350 million of principal on long-term debt instruments which sets us up on a path to achieving net leverage below 4 times by year-end. Midterm will aim to drive further improvements in net leverage with the goal of achieving net leverage of 3.5 times or below by the end of 2026.

    今年迄今為止,我們正在順利實現這一目標。正如我們上個季度向您表示的那樣,我們致力於減輕債務負擔。為此,我們在第二季償還了約 3.5 億美元的長期債務工具本金,這為我們在年底前實現淨槓桿率低於 4 倍的目標奠定了基礎。中期將致力於推動淨槓桿率的進一步改善,目標是到2026年底實現淨槓桿率不超過3.5倍。

  • Let's now talk about franchise performance beginning with women's health. The women's health franchise grew 2% at constant currency in the second quarter of 2025 compared with the second quarter of 2024. The company's fertility business grew 15% at constant currency in the second quarter.

    現在讓我們從女性健康開始討論特許經營的表現。2025 年第二季度,女性健康特許經營額以固定匯率計算與 2024 年第二季度相比增長了 2%。該公司生育業務第二季以固定匯率計算成長了 15%。

  • This was driven by a favorable year-over-year comparison in Follistim related to the late 2023 exit of a spin-related interim operating model with Merck and increased demand. we expect continuous growth in the US, along with geographical expansion to deliver high single-digit growth in our global fertility business in 2025.

    這是由於 Follistim 的同比表現良好,這與 2023 年底與默克公司退出分拆相關的臨時營運模式以及需求增加有關。我們預計美國市場將持續成長,同時地域擴張將使我們的全球生育業務在 2025 年實現高個位數成長。

  • Within women's health, Jada also grew double digit in the quarter and year-to-date. Among hospitals that have the highest adoption rates, Jada is used in nearly half of all postpartum hemorrhage care situations. We're focused on driving similar usage rates across more hospitals and are driving to have Jada incorporated into the standard postpartum hemorrhage readiness and response protocols in US hospitals. Sales of Nexplanon declined 1% in constant currency in the second quarter. Revenue declined by 5% in the US, all outside the US, Nexplanon grew 10% at constant currency.

    在女性健康領域,Jada 本季和年初至今也實現了兩位數的成長。在採用率最高的醫院中,近一半的產後出血護理情況都採用了 Jada。我們致力於在更多醫院推動類似的使用率,並推動將 Jada 納入美國醫院的標準產後出血準備和應對協議中。以固定匯率計算,第二季 Nexplanon 的銷售額下降了 1%。美國本土收入下降了 5%,而美國以外地區的收入以固定匯率計算增加了 10%。

  • For the first six months of the year, Nexplanon has grown 6% globally at constant currency. In the US, customers relying on federal and state subsidized programs are now facing potentially constrained funding satisfactoring into their purchasing decisions for contraceptive products. Despite these headwinds, we anticipate continued global growth for Nexplanon, building on its strong double-digit expansion achieved in 2024.

    今年前六個月,Nexplanon 的全球銷售額以固定匯率計算成長了 6%。在美國,依賴聯邦和州補貼計畫的消費者現在面臨資金受限的問題,這會影響他們購買避孕產品的決策。儘管面臨這些不利因素,我們預計 Nexplanon 將繼續在全球範圍內增長,並在 2024 年實現強勁的兩位數擴張的基礎上繼續增長。

  • Current policy issues notwithstanding, we remain committed to building Nexplanon into a $1 billion franchise in the very near future, reflecting our confidence in its long-term growth potential. For Nexplanon's five-year duration indication, we have made our submission to the FDA, putting us in a position to be ready for launch later this year.

    儘管目前存在政策問題,我們仍然致力於在不久的將來將 Nexplanon 打造為價值 10 億美元的特許經營企業,這反映了我們對其長期成長潛力的信心。對於 Nexplanon 的五年療程適應症,我們已向 FDA 提交了申請,準備在今年稍後上市。

  • As we have reiterated each quarter, we believe this indication is attractive to a much broader addressable market, and we believe Nexplanon can continue to grow until the end of the decade.

    正如我們每季所重申的那樣,我們相信這一適應症對更廣泛的目標市場具有吸引力,並且我們相信 Nexplanon 可以持續增長到本世紀末。

  • Turning to discussion to General Medicines, which is our refreshed term for our business outside of women's health. We believe it is a better characterization of the innovation we are introducing with products like Emgality and VTAMA.

    談到普通藥物的討論,這是我們對女性健康以外業務的新術語。我們相信,它更好地體現了我們透過 Emgality 和 VTAMA 等產品引入的創新。

  • We will continue to discuss our biosimilars products separately given their collective importance as a growth driver for the company. So then let's start with biosimilars, which is performing better than our expectations. Year-to-date performance is largely driven by Hadlima, which has generated almost $100 million as of June, up 68% compared with the prior year period.

    鑑於生物相似藥產品作為公司成長動力的重要性,我們將繼續分別討論它們。那麼讓我們從生物相似藥開始,它的表現比我們的預期要好。今年迄今的業績主要得益於 Hadlima 的貢獻,截至 6 月份,該公司的營收已接近 1 億美元,較去年同期成長 68%。

  • In the US Hadlima continues to rank among the leading biosimilars in terms of total prescriptions. This performance reflects the strong clinical profile of Hadlima, which includes the recent interchangeability approval. Hadlima has also benefited from the effectiveness of our commercial strategy and our market access teams, which have expanded availability to a broader patient population. We've also added (Operator Instructions) the first biosimilar approved for Actemra to the portfolio in the US.

    在美國,Hadlima 在總處方量方面繼續位居領先的生物相似藥之列。這一表現反映了哈德利馬強大的臨床表現,其中包括最近獲得的可互換性批准。哈德利馬也受益於我們有效的商業策略和市場准入團隊,從而擴大了對更廣泛患者群體的可及性。我們也將(操作員指示)第一個核准的 Actemra 生物相似藥添加到美國的產品組合中。

  • Immunology is a market we know well in the US notably the physician-administered business, and as a result, we are uniquely positioned to drive topedine sales. Finally, we will begin to launch a portfolio of Henlius products in late 2025 with a denosumab biosimilar in the US.

    免疫學是我們在美國非常了解的市場,尤其是由醫生管理的業務,因此,我們在推動托比定銷售方面具有獨特的優勢。最後,我們將於 2025 年底在美國推出 Henlius 產品組合,其中包括地舒單抗生物相似藥。

  • So with better performance in the base business, together with our outlook for new assets coming online that have improved our view of performance in the biosimilar business for the full year. Wrapping up the revenue discussion with established brands with a focus on VTAMA. VTAMA had strong performance in the second quarter with revenue of $31 million, up 35% sequentially and up 70% versus a year ago when it was still under Derma van.

    因此,由於基礎業務表現較好,加上我們對新資產上線的展望,改善了我們對全年生物相似藥業務表現的看法。與知名品牌進行收入討論,並專注於 VTAMA。VTAMA 第二季表現強勁,營收達 3,100 萬美元,較上一季成長 35%,比去年同期(當時仍由 Derma van 管理)成長 70%。

  • In the second quarter, NRx and TRx each grew mid-teens over Q1, representing the strongest quarterly performance among the peer set. Since launch, we have added over 20,000 new VTAMA prescribers. When Organon acquired Dermavant VTAMA was accessible to about 1/3 of the addressable population and broader access had significant barriers.

    在第二季度,NRx 和 TRx 的成長率均比第一季高出十幾個百分點,是同類產品中最強勁的季度表現。自推出以來,我們已增加了超過 20,000 名新的 VTAMA 處方者。當 Organon 收購 Dermavant 時,VTAMA 可供大約 1/3 的目標人口使用,而更廣泛的訪問則存在重大障礙。

  • We have achieved meaningful improvements in our access objectives to date and are on track to achieve 80% of the addressable population covered in both national and regional health care plans by early 2026.

    迄今為止,我們在醫療覆蓋目標方面已取得顯著進展,預計在 2026 年初實現 80% 的目標人口納入國家和地區醫療保健計劃。

  • We've only just begun to unlock the potential of this asset. VTAMA is approved for patients as young as two years of age. This unlocks the pediatric segment where treatment options are limited and safety concerns with existing therapies are significant. Other competitors in this space have labels approved for 6 years of age and up.

    我們才剛開始釋放這項資產的潛力。VTAMA 已獲批准用於年僅兩歲的患者。這打開了兒科領域的大門,因為該領域的治療選擇有限,而且現有療法的安全性問題十分嚴重。該領域的其他競爭對手已獲得 6 歲及以上兒童適用的標籤。

  • So this is a subset of pediatrics where we have a significant advantage. As we reflect on the first half of 2025, we're proud of several key accomplishments that have set a strong foundation for the remainder of the year.

    因此,這是我們在兒科領域具有顯著優勢的領域。回顧 2025 年上半年,我們為幾項關鍵成就感到自豪,這些成就為今年剩餘時間奠定了堅實的基礎。

  • Our portfolio is performing well, overcoming and mitigating the negative effects of the LOE and the EU of our second largest product, Atozet. We have created efficiencies in our expense base, which are reflected in our year-to-date results and in our adjusted EBITDA margin guidance.

    我們的產品組合表現良好,克服並減輕了 LOE 和歐盟對我們第二大產品 Atozet 的負面影響。我們提高了費用基礎的效率,這反映在我們年初至今的績效和調整後的 EBITDA 利潤率指引中。

  • We took action on our capital allocation priorities in order to accelerate the reduction of our net leverage, paying down principal on long-term debt, and we have a clear pathway to achieving a net leverage ratio below 4x by the end of this year. And finally, we acquired a new growth catalyst in VTAMA year-to-date, we're right where we wanted to be with VTAMA, making significant progress on our access objectives, which gives us confidence in our ability to deliver on our 2025 VTAMA revenue objective.

    我們對資本配置優先事項採取了行動,以加速降低淨槓桿率,償還長期債務的本金,並且我們有明確的途徑在今年年底前實現淨槓桿率低於 4 倍。最後,今年迄今為止,我們在 VTAMA 中獲得了新的成長催化劑,我們正處於 VTAMA 所希望達到的水平,在我們的訪問目標上取得了重大進展,這使我們對實現 2025 年 VTAMA 收入目標的能力充滿信心。

  • I'll now turn the call over to Matt, who will review the financials in more detail.

    我現在將電話轉給馬特,他將更詳細地審查財務狀況。

  • Matthew Walsh - Chief Financial Officer, Executive Vice President

    Matthew Walsh - Chief Financial Officer, Executive Vice President

  • Thank you, Kevin. Beginning on slide 8, where we bridge our second quarter revenue of 1.594 billion year-on-year. Overall, revenue was down 1%, both as reported and at constant currency, which aligns with our guidance expectations at the halfway point.

    謝謝你,凱文。從第 8 張投影片開始,我們第二季的營收與去年同期相比成長了 15.94 億美元。總體而言,無論是報告收入還是按固定匯率計算,收入均下降了 1%,這與我們中期的指導預期一致。

  • Starting on the left, loss of exclusivity was about $60 million for the quarter, which primarily reflects the impact of the LOE of Atozet in Europe, which occurred in September 2024. six months year-to-date, we are at $120 million of impact from LOE, meaning we are about 2/3 of the way through our full year estimate.

    從左邊開始,本季的獨家經營權損失約為 6,000 萬美元,這主要反映了 2024 年 9 月發生的 Atozet 在歐洲的 LOE 的影響。今年迄今為止的六個月,我們受到 LOE 的影響為 1.2 億美元,這意味著我們已經完成了全年估計的 2/3。

  • We will see that head would mitigate in the fourth quarter when we start lapping the LOE of Atozet in the EU. VVP in China was de minimis in the second quarter and year-to-date. -- and we expect only a nominal impact on a full year basis for 2025. Our potential exposure this fiscal year will be more back half weighted as we expect Fosamax will be included in Round 11. There was an approximate $40 million impact from price for the second quarter or about 2.5%.

    當我們開始在歐盟範圍內評估 Atozet 的 LOE 時,我們將看到第四季度這種情況將會緩解。在中國,第二季和今年迄今的 VVP 的影響微乎其微。 ——我們預計,到 2025 年,其對全年的影響僅是名義上的。由於我們預計 Fosamax 將納入第 11 輪,因此本財年我們的潛在風險敞口將更多地集中在後半部分。第二季的價格影響約為 4,000 萬美元,約 2.5%。

  • Pricing pressure was primarily from the LOE of Atozet as well as from certain mature products in the US like NuvaRing, Dulera, Renflexis and Ontrazon. We also continue to face expected mandatory pricing revisions in certain regional markets, for example, Japan. Volume increased $90 million in the quarter, representing growth of about 5.6%.

    定價壓力主要來自 Atozet 的 LOE 以及美國某些成熟產品,如 NuvaRing、Dulera、Renflexis 和 Ontrazon。我們也將繼續面臨某些區域市場(例如日本)預期的強制性定價調整。本季交易量增加了 9,000 萬美元,增幅約 5.6%。

  • Fertility, Hadlima and Emgality and VTAMA were the largest contributors to volume growth in the quarter. In Supply other, here, we capture the lower-margin contract manufacturing arrangements that we have with Merck, which have been declining since the spin-off as expected.

    Fertility、Hadlima 和 Emgality 以及 VTAMA 是本季銷量成長的最大貢獻者。在「供應其他」中,我們捕獲了與默克公司達成的利潤較低的合約製造安排,這些安排自分拆以來一直在下降,正如預期的那樣。

  • And lastly, foreign exchange translation had an approximate $10 million favorable impact in the quarter, which reflects the weaker US dollar versus the majority of foreign currencies in which we transact. Now let's turn to slide 9, where we show key non-GAAP P&L line items and metrics for the quarter.

    最後,外匯折算在本季度產生了約 1000 萬美元的有利影響,這反映了美元相對於我們交易的大多數外幣的疲軟。現在讓我們翻到第 9 張投影片,其中展示了本季的關鍵非 GAAP 損益項目和指標。

  • For reference, GAAP financials and reconciliations to the non-GAAP financial measures are included in our press release, and the slides in the appendix of this presentation. For gross profit, we are excluding purchase accounting amortization and onetime items from cost of goods sold, which can be seen in our appendix slide.

    作為參考,我們的新聞稿和本簡報附錄中的幻燈片包含了 GAAP 財務數據和與非 GAAP 財務指標的對帳。對於毛利,我們從銷售成本中排除了購買會計攤銷和一次性項目,這可以在我們的附錄幻燈片中看到。

  • Adjusted gross margin was 61.7% for the second quarter compared with 62% in the second quarter of 2024. The modest year-over-year decrease in adjusted gross margin primarily reflects the favorable impact of foreign exchange on our inventory turns in the period, more than offset by price, as I discussed. Year-to-date, our operating expenses are down 2%, which reflects operational discipline and an element of favorable timing of spend in both SG&A and R&D. Year-to-date adjusted EBITDA margin was 32.4%, which is running above the high end of our 31% to 32% guidance range for the full year.

    第二季調整後毛利率為 61.7%,而 2024 年第二季為 62%。調整後毛利率同比小幅下降主要反映了外匯對我們本期庫存週轉率的有利影響,正如我所討論的,但價格的上漲抵消了這一影響。年初至今,我們的營運費用下降了 2%,這反映了營運紀律以及銷售、一般及行政費用和研發支出的有利時機因素。年初至今的調整後 EBITDA 利潤率為 32.4%,高於我們全年 31% 至 32% 的指導範圍的高端。

  • We expect second half adjusted EBITDA margins to moderate and expect the full year to land within our existing adjusted EBITDA margin guidance range as we continue to invest in the BITAMA launch and the timing of clinical spending in R&D catches up with our full year expectation.

    我們預計下半年調整後的 EBITDA 利潤率將會放緩,並且預計全年將在我們現有的調整後的 EBITDA 利潤率指導範圍內,因為我們將繼續投資於 BITAMA 的發布,並且研發臨床支出的時間趕上了我們的全年預期。

  • On the full year, we expect total OpEx, which we define as the sum of SG&A and R&D expenses to be generally flat with prior year based on our objective to achieve $20 million of operational savings in 2025 that would help offset investment in our growth drivers, especially butane.

    就全年而言,我們預計總營運支出(我們將其定義為銷售、一般及行政費用和研發費用的總和)將與上年基本持平,因為我們的目標是到 2025 年實現 2000 萬美元的營運節約,這將有助於抵消對成長動力(尤其是丁烷)的投資。

  • Turning to free cash flow now on slide 10. We delivered $525 million of free cash flow before onetime costs in the first half, ahead of where we were this time last year. This is a function of active cash cycle working capital management, lower interest expense on our debt and favorable first half timing of cash tax payments.

    現在轉到第 10 張投影片討論自由現金流。我們在上半年實現了 5.25 億美元的自由現金流(扣除一次性成本),高於去年同期的水平。這是積極的現金週期營運資本管理、較低的債務利息支出以及有利的上半年現金納稅時機的結果。

  • Onetime costs related to the spin-off were completed in 2024, following the rollout of our global ERP system and as a result, these costs are zero in the first half of 2025 compared with $117 million in the prior year period. six months year-to-date, we recorded $175 million in other onetime costs, broken out as follows: Approximately $75 million relates to cash payments associated with the restructuring initiatives we are executing to deliver $200 million of operating savings this year, as I mentioned earlier. $20 million relates to the final payment of the Microspherex legal settlement. And the remaining $80 million relates to the planned exits from supply arrangements with Merck.

    與分拆相關的一次性成本已於 2024 年在我們推出全球 ERP 系統後完成,因此,2025 年上半年這些成本為零,而去年同期為 1.17 億美元。今年迄今的六個月,我們記錄了 1.75 億美元的其他一次性成本,具體如下:約 7500 萬美元與我們正在執行的重組計劃相關的現金支付,正如我之前提到的,這些計劃旨在在今年實現 2 億美元的營運節餘。 2000 萬美元與 Microspherex 法律和解的最終付款有關。剩餘的 8000 萬美元與計劃退出與默克的供應協議有關。

  • We discussed in past quarters, these costs would be ramping up. These are activities that will enable Organon to redefine our appropriate sourcing strategy and move to fit-for-purpose supply chains while focusing on delivering efficiencies in terms of gross margin expansion, which we expect to begin realizing in 2027.

    我們在前幾個季度討論過,這些成本將會增加。這些活動將使 Organon 能夠重新定義我們適當的採購策略,並轉向適合用途的供應鏈,同時專注於提高毛利率擴張方面的效率,我們預計這一目標將在 2027 年開始實現。

  • Our original estimate for these restructuring and manufacturing separation activities was $325 million to $375 million in 2025. While we are tracking to the midpoint of this range at the halfway point, our view into the second half is pointing to lower cash outlay.

    我們最初估計,到 2025 年,這些重組和製造分離活動的成本將達到 3.25 億美元至 3.75 億美元。雖然我們在中期追蹤到了這個範圍的中點,但我們對下半年的看法是現金支出將會減少。

  • As a result, we are improving our estimate by $75 million at the midpoint. Our updated estimate for restructuring and manufacturing separation activities for 2025 is now $250 million to $300 million, with the improvement being realized in lower restructuring costs.

    因此,我們將中間值提高了 7500 萬美元。我們對 2025 年重組和製造分離活動的最新估計現為 2.5 億至 3 億美元,其中重組成本的降低帶來了改善。

  • We slightly increased our estimate of business development cash investments for 2025 from approximately $200 million to approximately $230 million, with the increase being driven by the modest upfront payment to acquire commercial rights (inaudible) .

    我們將 2025 年業務發展現金投資的估計從約 2 億美元略微上調至約 2.3 億美元,這一增長是由於收購商業權利的適度預付款所致(聽不清楚)。

  • On an absolute basis, the majority of the $230 million pertains to commercial milestone payments tied to the sales of VTAMA, Emgality and the biosimilar programs with Shanghai Henlius. Through the first half of the year, we've paid about $150 million towards that total.

    從絕對值來看,這 2.3 億美元中的大部分涉及與 VTAMA、Emgality 以及與上海復宏漢霖合作的生物相似藥項目的銷售相關的商業里程碑付款。今年上半年,我們已支付約 1.5 億美元。

  • The achievement of these milestones means we are realizing value for business development deals already signed and validates the path to low to mid-single-digit revenue growth rate post 2025 that we've been saying Organon should be able to deliver.

    這些里程碑的實現意味著我們正在實現已簽署的業務發展協議的價值,並驗證了我們一直認為 Organon 應該能夠實現的 2025 年後低至中等個位數收入增長率的道路。

  • Turning now to leverage on slide 11. In the first quarter, we revised our capital allocation priorities, increasing the retention ratio of our free cash flow with the stated goal of applying that cash to debt repayment.

    現在轉到投影片 11 上的槓桿作用。在第一季度,我們修改了資本配置重點,提高了自由現金流的留存率,明確目標是將該現金用於償還債務。

  • In the second quarter, we took immediate action and started to put that cash to work. During the quarter, we made principal payments on long-term debt totaling $345 million. We repurchased and canceled $242 million of our 5.5% notes due in 2031 prior to maturity, which resulted in a pretax gain on extinguishment of debt of $42 million at an average purchase price of 82.6% of face value.

    在第二季度,我們立即採取行動並開始使用這些現金。本季度,我們支付了總額為 3.45 億美元的長期債務本金。我們提前回購並取消了 2.42 億美元的 2031 年到期的 5.5% 票據,導致以平均購買價格為票面價值的 82.6% 計算,債務清償稅前收益為 4,200 萬美元。

  • We also paid off and terminated a legacy funding agreement in Dermavant valued at $103 million which resulted in a pretax gain on extinguishment of $4 million. On an after-tax basis, the $46 million gain across both retirements added $0.14 per share to our GAAP earnings per share in the second quarter. The return on the debt repurchase was compelling, and we advanced our revolver to prudently maximize the trade.

    我們還償還並終止了 Dermavant 價值 1.03 億美元的遺留融資協議,這帶來了 400 萬美元的稅前收益。以稅後計算,兩次退休共帶來 4,600 萬美元收益,為我們第二季的 GAAP 每股收益增加了 0.14 美元。債務回購的回報非常可觀,我們推進了循環信貸以審慎地實現交易最大化。

  • We intend to pay off the balance on the revolver by year-end as discretionary cash builds in the second half of the year. As a result of these actions, we were able to maintain net leverage ratio flat to Q1 despite the impact of a weakening dollar, which increased by approximately $250 million, the translated US dollar value of our euro-denominated debt.

    隨著下半年可自由支配現金的積累,我們打算在年底前還清循環信貸的餘額。由於採取了這些措施,儘管受到美元疲軟的影響,我們仍能將淨槓桿率維持在與第一季持平的水平,美元疲軟導致我們以歐元計價的債務的美元價值增加了約 2.5 億美元。

  • We continue to see a path to achieving net leverage below 4x by year-end. And over time, the capital preserved with a higher retention ratio creates a compounding improvement in financial flexibility, which offers us the opportunity to achieve faster and more meaningful deleveraging over the next few years.

    我們仍然看到了到年底實現淨槓桿率低於 4 倍的途徑。隨著時間的推移,以更高的留存率保留的資本將帶來財務靈活性的複合改善,這為我們提供了在未來幾年實現更快、更有意義的去槓桿的機會。

  • Now turning to 2025 full year revenue guidance on slide 12. We are raising our estimate for full year revenue based on year-to-date favorability in foreign exchange translation in our belief that this favorability will persist at or close to current spot rates for the remainder of 2025.

    現在轉到第 12 張投影片上的 2025 年全年收入指引。我們根據年初至今外匯折算的有利條件上調了全年收入的預期,因為我們相信,在 2025 年剩餘時間內,這種有利條件將維持在當前即期匯率或接近當前即期匯率的水平。

  • In summary, we are raising our revenue guide by $100 million at the midpoint of the range. The operational components of this revised revenue bridge look very similar to the one we provided in May following Q1 earnings. The only change of any significance is on FX.

    總而言之,我們將營收預期上調 1 億美元,處於該範圍的中間值。修訂後的收入橋樑的營運組成部分與我們在 5 月第一季收益之後提供的收入橋樑的營運組成部分非常相似。唯一具有重大意義的變化是外匯方面。

  • In May, we had said that currency could be as much as a $200 million headwind in 2025, but should a weakening dollar persist, we would see upside, and that appears to be occurring. Given current rates, we are now estimating a $50 million FX headwind year-on-year or approximately 75 basis points on our full year revenue growth, driven by the euro the Mexican peso, Canadian dollar, Chinese yuan and Korean won. Within the operational bars, we've modestly revised our ranges on LOE, VBP and volume.

    今年 5 月,我們曾表示,到 2025 年,貨幣可能會帶來高達 2 億美元的逆風,但如果美元持續走弱,我們將看到上行空間,而這種情況似乎正在發生。根據目前的匯率,我們估計,受歐元、墨西哥比索、加幣、人民幣和韓元的影響,外匯逆風將年減 5,000 萬美元,或對全年收入成長造成約 75 個基點的影響。在操作欄內,我們適度修改了 LOE、VBP 和音量的範圍。

  • For volume, we narrowed the range and took down the midpoint a bit to reflect conservatism with regard to some risk in the General Medicines based business, specifically as it relates to the respiratory portfolio.

    對於交易量,我們縮小了範圍並稍微降低了中點,以反映對基於普通藥品的業務中的某些風險的保守態度,特別是與呼吸產品組合相關的風險。

  • Those products have been under pressure in the first half of the year due to a mild respiratory season in certain markets. The 6% growth rate midpoint of the volume guide implies very strong volume growth in the second half of the year, which will mainly be driven by continued uptake of VTAMA, but also Emgality, biosimilars and Nexplanon.

    由於某些市場呼吸道疾病季節較為溫和,這些產品在上半年面臨壓力。銷售指南中 6% 的成長率中點意味著下半年銷售成長非常強勁,這主要得益於 VTAMA 的持續成長,同時也得益於 Emgality、生物相似藥和 Nexplanon 的持續成長。

  • Taken together, the midpoint of our constant currency revenue guide is still about flat versus prior year. We expect the uptake of VTAMA, continued solid performance in Emgality, Nexplanon and Hadlima, will help to offset the LOE of Atozet in Europe, along with typical pricing headwinds in other parts of the portfolio.

    綜合來看,我們的恆定貨幣收入指南的中點與前一年相比仍然持平。我們預期 VTAMA 的普及、Emgality、Nexplanon 和 Hadlima 的持續穩健表現將有助於抵消 Atozet 在歐洲的 LOE,以及投資組合其他部分的典型定價阻力。

  • From a quarterly phasing perspective, we expect Q3 revenue should be flat with last year on a reported basis with some modest growth year-over-year coming in the fourth quarter. That will be driven by lapping the LOE of Atozet, which occurred in September 2024 as well as the continued uptake of VTAMA.

    從季度分階段來看,我們預計第三季的營收應與去年持平,而第四季的營收將比去年同期略有成長。這將受到 2024 年 9 月發生的 Atozet LOE 重疊以及 VTAMA 的持續吸收的推動。

  • Turning to slide 13, where we show all components of our earnings guidance. We continue to expect adjusted gross margin to be in the range of 60% to 61%. Adjusted gross margin was strong year-to-date, given favorable FX changes on our inventory turns. We expect adjusted gross margin will be lower in the second half, but we believe we will land the year closer to the high end of the range at 61%.

    翻到第 13 張投影片,我們展示了獲利預測的所有組成部分。我們繼續預計調整後的毛利率將在 60% 至 61% 之間。由於外匯變化有利於我們的庫存週轉,今年迄今調整後的毛利率保持強勁。我們預計下半年調整後的毛利率將會下降,但我們相信全年的毛利率將接近 61% 的高端。

  • With regard to tariffs, the industry does not yet have the clarity required to be able to talk about specific impacts. For Organon, we can say that our guidance incorporates documented tariffs related to Canada, Mexico and China.

    關於關稅,業界尚未明確討論具體影響。對於 Organon,我們可以說我們的指導包含了與加拿大、墨西哥和中國相關的記錄關稅。

  • As a hypothetical sensitivity, we can also say that the EU is our most significant exposure from an import standpoint to the US. And we're comfortable saying that an EU tariff on pharmaceuticals of up to 15% alone would not cause us to lower our range on adjusted gross margin for 2025.

    作為一種假設的敏感性,我們也可以說,從進口的角度來看,歐盟是我們對美國最重要的影響因素。我們可以放心地說,歐盟對藥品徵收高達 15% 的關稅不會導致我們降低 2025 年調整後毛利率的範圍。

  • Moving on to OpEx, as I mentioned earlier, we still expect SG&A and R&D expense to land the year within the ranges we've been providing with favorability in the first half attributable to timing. We continue to expect our adjusted EBITDA margin to be in the range of 31% to 32% for the full year.

    談到營運支出,正如我之前提到的,我們仍然預計銷售、一般及行政費用和研發費用將在全年保持在我們所提供的範圍內,而上半年由於時機因素而表現良好。我們繼續預計全年調整後的 EBITDA 利潤率將在 31% 至 32% 之間。

  • If you do a second half implied P&L calculation using the midpoint of our guide, you're probably modeling adjusted EBITDA margins in the neighborhood of 30.5% in the back half, which is a pretty good estimate for both the third and fourth quarters individually.

    如果您使用我們的指南中點來計算下半年的隱含損益,那麼您可能會對下半年的調整後 EBITDA 利潤率進行建模,該利潤率約為 30.5%,這對於第三季度和第四季度來說都是一個相當不錯的估計。

  • For below-the-line items, our estimate for full year 2025 interest expense remains at $510 million. The lower interest expense from voluntarily retired debt is essentially fully offset by higher euro-denominated interest expense due to FX translation and an acceleration of noncash amortization of capitalized fees related to the debt retirement. As we think about next year, we would expect interest expense to be closer to $475 million run rate as a result of the voluntary debt repayments completed this quarter, all else held equal.

    對於低於標準項目,我們對 2025 年全年利息支出的估計仍為 5.1 億美元。自願償還債務的較低利息支出基本上被外匯折算和與債務償還相關的資本化費用非現金攤銷加速導致的歐元計價利息支出增加所完全抵消。展望明年,我們預計,在其他條件不變的情況下,由於本季完成的自願債務償還,利息支出將接近 4.75 億美元的運行率。

  • For 2025, we continue to estimate our non-GAAP tax rate to be in the range of 22.5% to 24.5%. The uptick from 2024 is largely due to the impact of the 15% global minimum tax rate required under the OECD's Pillar 2. Depreciation of $135 million remains our estimate for full year 2025.

    到 2025 年,我們繼續估計我們的非 GAAP 稅率將在 22.5% 至 24.5% 之間。2024年以後的上漲主要是受經合組織第二支柱規定的15%全球最低稅率的影響。我們仍預期 2025 年全年折舊額為 1.35 億美元。

  • In summary, our year-to-date results were solidly aligned with our expectations at the start of the year. We see a very realistic path of maintaining total revenue about level with prior year, which is noteworthy given the LOE of Atozet, our second largest product that we're facing this year.

    總而言之,我們今年迄今的業績與年初的預期完全一致。我們看到了將總收入維持在與去年大致相同的水平的非常現實的途徑,考慮到我們今年面臨的第二大產品 Atozet 的 LOE,這一點值得注意。

  • VTAMA will play an important role in achieving this result. From a profitability standpoint, we are tracking well to our cost reduction goals, and we continue to improve our OpEx efficiency metric. 2025 is likely to be our strongest OpEx efficiency since the spin-off.

    VTAMA 將在實現這一結果的過程中發揮重要作用。從獲利能力的角度來看,我們正在順利實現成本削減目標,並將繼續提高我們的營運支出效率指標。 2025 年很可能是我們分拆以來營運支出效率最高的一年。

  • If we achieve the midpoint of our adjusted EBITDA margin guidance range, that would represent almost a full point of improvement over last year. And finally, we're on the right path with regard to deleveraging. Following our reprioritization of capital allocation, we were quick to act in the second quarter, and we're successful in repurchasing debt in the open market, yielding a very attractive return.

    如果我們達到調整後的 EBITDA 利潤率指導範圍的中點,這將比去年幾乎提高整整一個點。最後,我們在去槓桿方面走在了正確的道路上。在重新調整資本配置優先順序後,我們在第二季迅速採取行動,並成功在公開市場上回購債務,獲得了非常可觀的回報。

  • Combined with free cash flow, which we expect will be in excess of $900 million for 2025, we continue to see a path to sub-4 times net leverage ratio by year-end, which is an important mile marker on our way to even lower leverage in 2026.

    結合我們預計 2025 年將超過 9 億美元的自由現金流,我們預計到年底淨槓桿率將低於 4 倍,這是我們在 2026 年進一步降低槓桿率的重要里程碑。

  • And with that, we'll now turn the call over to Q&A.

    現在,我們將把電話轉入問答環節。

  • Operator

    Operator

  • (Operator Instructions)

    (操作員指示)

  • David Amsellem with Piper Sandler.

    大衛‧阿姆塞勒姆 (David Amsellem) 與派珀‧桑德勒 (Piper Sandler)。

  • David Emily - Analyst

    David Emily - Analyst

  • Hi, good morning. Thanks for taking our question. This is Alex on for David. Just 1 on the Tama from us. Looking further ahead, can you talk to incremental sales and marketing investment, whether it's DTC or sales force expansion or both? And can you also remind us how many practitioners you are currently calling on and how many reps you currently have supporting the product?

    嗨,早安。感謝您回答我們的問題。這是亞歷克斯為大衛表演的。Tama 上離我們只有 1 個。展望未來,您能否談談增量銷售和行銷投資,無論是 DTC 還是銷售團隊擴張,還是兩者兼具?您能否提醒我們,您目前正在呼叫多少名從業者以及目前有多少名代表支持該產品?

  • Thank you.

    謝謝。

  • Kevin Ali - Chief Executive Officer, Director

    Kevin Ali - Chief Executive Officer, Director

  • So thanks for the question, Alex. So yes, as a matter of fact, in July, we started a new telehealth and DTC campaigns, coupled with pediatric initiatives or programs to penetrate into the pediatric segment. And so currently, we feel very comfortable with where we're going in terms of the investments for the second half of the year. They're more weighted or loaded towards the second half. And so things are moving along exactly where we thought they would be at this period of time.

    謝謝你的提問,亞歷克斯。是的,事實上,我們在 7 月啟動了一項新的遠距醫療和 DTC 活動,同時也開展了兒科計劃或項目,以滲透到兒科領域。因此,目前,我們對下半年的投資方向感到非常滿意。他們更加重視下半場。因此,事情的進展正如我們所預期的。

  • And we feel good in terms of overall positioning of where we are with VTAMA right now, and we're expanding. And currently, in terms of your question around reps, so we did add more reps. And I talked about DTC. So we added more sales force, and we've got now a total of more than 125 reps in the field.

    我們對 VTAMA 目前的整體定位感到滿意,我們正在不斷擴張。目前,就您關於代表的問題而言,我們確實增加了更多代表。我談到了 DTC。因此,我們增加了更多的銷售人員,現在我們在該領域的銷售代表總數已超過 125 名。

  • Operator

    Operator

  • Michael Nedelcovych from TD Cowen.

    TD Cowen 的 Michael Nedelcovych。

  • Michael Nedelcovych - Analyst

    Michael Nedelcovych - Analyst

  • Hi, thank you for the questions. I have two. My first is on Mislan. Can you elaborate on the oral funding headwinds you cited in the US? To what extent was the decline in US Nexplanon sales this quarter related to purchase timing versus underlying pressures that might persist through the rest of the year and beyond? And then my second question is on capital allocation. As you approach and then exceed your leverage ratio targets how do you expect your capital allocation priorities to change what might become the top priority?Thank you.

    你好,謝謝你的提問。我有兩個。我的第一個作品是在 Mislan 上。您能否詳細說明您提到的美國口頭融資阻力?本季美國 Nexplanon 銷售額的下降在多大程度上與購買時機有關,還是與可能持續到今年剩餘時間甚至更久的潛在壓力有關?我的第二個問題是關於資本配置。當你接近並超過你的槓桿率目標時,你預期你的資本配置優先順序將如何變化,什麼可能成為首要任務?謝謝你。

  • Kevin Ali - Chief Executive Officer, Director

    Kevin Ali - Chief Executive Officer, Director

  • Yeah, Mike, I can get started with that. With Nexplanon, it's a combination of both. Look, I mean, with the most recent big beautiful build. There were some effects in terms of overall on planned parenthood and Medicaid-related funding. And so -- there's a lot of kind of the some nervousness in the market, especially when it comes to purchase of contraception as well.

    是的,麥克,我可以從那裡開始。Nexplanon 是兩者的結合。看,我的意思是,最近建造的那個美麗的大建築。總體而言,這對計劃生育和醫療補助相關資金產生了一些影響。因此,市面上存在著許多緊張情緒,尤其是在購買避孕藥具方面。

  • Remember that in the first quarter, we saw essentially the movement on USAID by the administration. But overall, we're seeing a lot of pickup ex US in countries like Brazil, Egypt and many other countries that are starting to pick up the slack. And we have a lot of confidence that the US AID numbers will start to -- or investment will start to pay off with regards to other sponsors coming in, picking up the tab on that.

    請記住,在第一季度,我們基本上看到了政府在美國國際開發署的動向。但整體而言,我們看到巴西、埃及等許多國家除美國外,其他許多國家也開始彌補不足。我們非常有信心,隨著其他贊助商的加入和支付,美國國際開發署的援助數字將開始顯現——或者說投資將開始產生回報。

  • Now in regards to where we are with the US still feel very confident that we'll grow this year with Nexplanon. But clearly, there's a lot of confusion in the market. We've got, I think, good news on Title X, unfreezing in certain states that are key for us like California and Texas. But there is a little bit of hesitancy, especially around the planned parenthood issues that are there that needs to be dealt with.

    現在,就我們在美國的情況而言,我們仍然非常有信心今年 Nexplanon 將會成長。但顯然,市場存在著許多混亂。我認為,我們在《第十修正案》方面有好消息,在加州和德克薩斯州等對我們至關重要的某些州解凍了該法案。但也存在一些猶豫,特別是在需要處理的計劃生育問題方面。

  • But we feel very confident that it's just a matter of in the near future, we'll reach that $1 billion threshold. And we'll see growth this year going forward, whether it lasts for the long term, remember, the planned parenthood issues were really -- 12 months in total. So once that's up and running, then ultimately, we'll be able to get back to it.

    但我們非常有信心,在不久的將來,我們將達到 10 億美元的門檻。我們將看到今年的成長,無論它是否能持續長期,請記住,計劃生育問題實際上——總共 12 個月。因此,一旦它啟動並運行,最終我們將能夠回到它。

  • But we feel very good about Nexmo being our key product. And remember that we're going to be launching the five-year indication sometime at the end of this year, so we feel good about that. In regards to leverage, well, ask us when we get down below 3.5.

    但我們對 Nexmo 作為我們的主要產品感到非常高興。請記住,我們將在今年年底的某個時候推出五年期計劃,因此我們對此感到很高興。至於槓桿率,當槓桿率低於 3.5 時再問我們。

  • And then we'll have a discussion on that. But right now, our focus is to delever. We did that with regards to the payment on principal debt in terms of the first quarter or what we just came right out with, and we'll continue to do that.

    然後我們將對此進行討論。但目前,我們的重點是去槓桿。我們已經在第一季償還了本金債務,或者說我們剛剛宣布了這一點,並且我們將繼續這樣做。

  • Operator

    Operator

  • Terence Flynn with Morgan Stanley.

    摩根士丹利的 Terence Flynn。

  • Terrence Flynn - Analyst

    Terrence Flynn - Analyst

  • Hi, thanks for taking the question. And thanks for all the clarity on the call. You guys mentioned that 15% tariff in the EU would not have an impact on '25 margins. Just wondering if you can look out to '26 and give us some idea what kind of impact it might have on '26. And then a similar question as you look out to 26, how should we think about free cash flow conversion and some of the onetime items. I know you've guided to those continuing to decline, but can you give us any sense of the magnitude there?

    你好,謝謝你回答這個問題。感謝您在通話中提供的所有清晰資訊。你們提到歐盟 15% 的關稅不會對 25 利潤產生影響。只是想知道您是否可以展望 26 年並告訴我們它可能對 26 年產生什麼樣的影響。然後當你看到 26 時,一個類似的問題是,我們應該如何看待自由現金流轉換和一些一次性項目。我知道您已經指導過那些持續下降的人,但是您能讓我們了解那裡的幅度嗎?

  • Thank you.

    謝謝。

  • Matthew Walsh - Chief Financial Officer, Executive Vice President

    Matthew Walsh - Chief Financial Officer, Executive Vice President

  • Yeah, So I'll take that one. It's a little bit too soon to be talking about tariff impacts out in 2026. It's not the right time for that. Just investors should know that our largest import exposure into the United States comes from the EU. It's approximately 2/3 of our imported value. So investors, knowing that can make some of their own math, but it's just too soon for us to speculate about 2026, whether we're talking about tariffs or anything else?

    是的,所以我選擇這個。現在談論 2026 年的關稅影響還為時過早。現在還不是做這件事的正確時機。投資者應該知道,我們對美國最大的進口來自歐盟。這大約占我們進口價值的2/3。因此,投資者知道這一點後可以進行一些自己的計算,但現在就猜測 2026 年的情況還為時過早,我們談論的是關稅還是其他什麼?

  • Kevin Ali - Chief Executive Officer, Director

    Kevin Ali - Chief Executive Officer, Director

  • And free cash. Flow.

    還有免費現金。流動。

  • Matthew Walsh - Chief Financial Officer, Executive Vice President

    Matthew Walsh - Chief Financial Officer, Executive Vice President

  • Yeah, free cash flow should be growing in line with the business. We'll continue to see a reduction in onetime costs. So we have been -- we've needed to make a differentiation between gross free cash flow and free cash flow, excluding onetime items. Those onetime items are declining. They've been declining this year. They will continue to decline into next year. So that will be a reason why you might see in addition to normal growth of the business. Discretionary cash flow increased pretty significantly next year.

    是的,自由現金流應該會隨著業務成長而成長。我們將繼續看到一次性成本的減少。因此,我們需要區分總自由現金流和不包括一次性項目的自由現金流。這些一次性物品正在減少。今年以來,這一數字一直在下降。明年,這一數字還將繼續下降。所以這就是您可能會看到業務除了正常成長之外還會出現成長的原因。明年可自由支配的現金流將大幅增加。

  • Operator

    Operator

  • Umer Raffat with Evercore.

    Evercore 的 Umer Raffat。

  • Umer Raffat - Equity Analyst

    Umer Raffat - Equity Analyst

  • Good morning, guys. I was just looking at VTAMA volume data. I recall you guys obviously got the atopic derm approval in December. So a couple of months into the launch, I think, around Feb, March time frame, it was generally hovering around 6,000 TRxs a week. And it's kind of in that same ballpark right now, a few months later.

    大家早安。我剛剛正在查看 VTAMA 體積數據。我記得你們顯然在 12 月獲得了異位性皮膚病的批准。因此,我認為在發布幾個月後,大約在二月、三月的時間範圍內,每週的交易量一般徘徊在 6,000 個交易日左右。幾個月後的現在,情況大致相同。

  • And I'm just trying to think about how you're looking at the volume data because I feel like sometimes we do year-over-year, and it could mask what's happening more near term? And is there something you want to do differently to turn the trajectory around?

    我只是想知道您是如何看待交易量數據的,因為我覺得有時我們會逐年進行數據對比,這可能會掩蓋近期發生的事情?您是否想做一些不同的事情來扭轉這一軌跡?

  • Kevin Ali - Chief Executive Officer, Director

    Kevin Ali - Chief Executive Officer, Director

  • Hey, Umar, Good to hear you. Listen, in regards to VTAMA, I mean there's a tug of war week by week. But overall, what I can tell you is the following, that we just started the investments right now. But we need to settle down.

    嘿,Umar,很高興聽到你的消息。聽著,關於 VTAMA,我的意思是每週都會有一場拉鋸戰。但總的來說,我可以告訴你的是,我們現在才剛開始投資。但我們需要安定下來。

  • Obviously, we just took over the product and get it launched and get it out there and do the right things at the initial stages. And now we have a very, I think, effective and full force behind our DTC campaign and our telehealth campaign and expanding in terms of sales force, in terms of what we're doing regarding penetrating into the pediatric segment as well as obviously continue to maintain our focus on the adult segment.

    顯然,我們只是接手了該產品,並將其推出市場,並在初始階段做正確的事情。現在,我認為,我們在 DTC 活動和遠距醫療活動背後擁有非常有效和全力的支持,並且在銷售隊伍方面不斷擴大,我們正在努力滲透到兒科領域,同時顯然會繼續保持對成人領域的關注。

  • But more importantly, the gross to net and lives covered continue to move in the right direction. Look, when you -- when access starts to open up in each individual physician's offices, whether it's a dermatology office or others, they know that when they start to hear that ultimately PBM start to accept it and for AD, you have less hesitancy about using, say, coupon cards, you have more fluency, more openness to be able to use the product on a more routine basis. And so now as we predicted, our access teams are working incredibly hard. They made huge strides, huge strides to get to 80% of the lives covered by Q1 of next year.

    但更重要的是,總收入與淨收入以及受保人數持續朝著正確的方向發展。你看,當每個醫生的辦公室都開始開放訪問時,無論是皮膚科辦公室還是其他辦公室,他們知道,當他們開始聽說 PBM 最終會開始接受它時,對於 AD,你會更少猶豫使用優惠券卡,你會更流暢、更開放地能夠更常規地使用該產品。正如我們所預測的,我們的訪問團隊正在非常努力地工作。他們取得了巨大的進步,到明年第一季度,這一目標將覆蓋 80% 的人群。

  • We're making incredible movements in that space as well, gross to net is precipitously dropping in the right direction real quick.

    我們也在該領域做出了令人難以置信的舉動,毛收入與淨收入之比正在迅速朝著正確的方向下降。

  • So once those two things happen, it's funny how that affects volume, volume starts to pick up because people understand it's being covered. In addition to that, you add our DTC and telehealth as well as our expansion in sales force. And I think you'll see good solid volume getting picked up. But more importantly, that every script will mean more net revenue for us as we start to get the gross debt in the right place.

    因此,一旦這兩件事發生,有趣的是,它會如何影響交易量,交易量開始回升,因為人們明白它被報導了。除此之外,您還可以加入我們的 DTC 和遠距醫療以及銷售團隊的擴張。我認為您會看到銷量大幅增長。但更重要的是,當我們開始將總債務放在正確的位置時,每個腳本都將為我們帶來更多的淨收入。

  • Umer Raffat - Equity Analyst

    Umer Raffat - Equity Analyst

  • But Kevin, just to maybe expand on that. The newer brand is not so bad. It's kind of growing, which sounds to me like there's a duration issue more so than an access issue.

    但是凱文,也許可以進一步闡述這一點。新品牌還不錯。它有點在不斷增長,在我看來,這更像是一個持續時間問題,而不是訪問問題。

  • Kevin Ali - Chief Executive Officer, Director

    Kevin Ali - Chief Executive Officer, Director

  • Well, I think that right now, what you see is an uptick in TRx. So you've got some refills coming in as we speak. You'll start to see more and more TRx uplift as the volume starts to move. But I agree with you. Look, I mean we've added a number of physicians right now who are new to brand. And we see these kind of seasonalities, but I feel really good about the second half of the year based on where we landed in terms of exiting Q2.

    嗯,我認為現在,您看到的是 TRx 的上升。因此,正如我們所說,您已經收到了一些補充。隨著交易量開始變動,您將開始看到越來越多的 TRx 提升。但我同意你的看法。你看,我的意思是我們現在增加了很多新加入品牌的醫生。我們看到了這種季節性,但根據我們在第二季結束時的狀況,我對下半年感到非常樂觀。

  • Q2 in terms of the last month was a very strong exit, it gives me a lot of confidence in terms of where we're headed.

    就上個月而言,第二季的業績表現非常強勁,這讓我對我們未來的發展方向充滿信心。

  • Operator

    Operator

  • Thank you, Mr. Umer.

    謝謝你,烏默爾先生。

  • The next question comes from Chris Schott with JP Morgan. Your line is open.

    下一個問題來自摩根大通的克里斯·肖特 (Chris Schott)。您的線路已開通。

  • Unidentified Participant

    Unidentified Participant

  • Hi, this is Ethan on for Chris Schott. Just starting off on VTAMA, can you remind us what's driving the ramp in the second half of the year? -- to get to the $150 million in sales and how much of that is driven by volume versus price? And then on Nexplanon, as we think about the launch of the five year indication, can you remind us on how we should think about the impact to growth in 2026 and '27? And specifically, what portion of current volumes are coming from implant replacements?

    大家好,我是 Ethan,為 Chris Schott 服務。剛開始談論 VTAMA,您能否提醒我們下半年推動銷售成長的因素是什麼? ——達到 1.5 億美元的銷售額,其中有多少是由銷售驅動,有多少是由價格驅動?然後關於 Nexplanon,當我們考慮推出五年適應症時,您能否提醒我們應該如何考慮其對 2026 年和 2027 年成長的影響?具體來說,目前的數量中有多少是來自植入物替換?

  • Kevin Ali - Chief Executive Officer, Director

    Kevin Ali - Chief Executive Officer, Director

  • Okay. Let me try to address those Ethan one after the next. So second half uplift in terms of VTAMA, -- we got -- and this is global, obviously, the $150 million. We've got $56 and another $90 something to go -- $94 to go.

    好的。讓我試著逐一解決這些問題,伊森。因此,就 VTAMA 而言,下半年我們獲得了提升,這顯然是全球性的,達到了 1.5 億美元。我們還差 56 美元,還有 90 多美元要還——還差 94 美元。

  • And so I believe very strongly that where we are right now in implementing our new activities around DTC, around telehealth, around expansion of sales force, around some of the things that we're doing around volume is really a very important lever to believe in for at least for me going forward. We're getting obviously a launch in Canada soon. We've got continuous implementation or rather contribution from Japan as well.

    因此,我堅信,我們現在在 DTC、遠距醫療、擴大銷售團隊以及圍繞銷售的新活動方面所做的一些事情,至少對我來說,確實是一個非常重要的槓桿。我們顯然很快就會在加拿大推出該產品。我們也得到了日本的持續實施或貢獻。

  • But overall, in the US, that's the key market, and we feel really good about where we landed in terms of exiting Q2. And I think the ramp in terms of where we see it gets us to the $150 million, especially if you look at how we exited Q2 and especially you look at where gross to net is falling in the right direction.

    但總體而言,美國是關鍵市場,我們對第二季的成績感到非常滿意。我認為,就我們所看到的而言,這一增長將使我們達到 1.5 億美元,特別是如果你看看我們是如何退出第二季度的,特別是你看看毛收入與淨收入的下降方向是否正確。

  • The gross to net issue was not great under the psoriasis indication, but the team has done a phenomenal job of both adding significant lives in terms of PBM additions as well as lowering our gross to net range because of less usage and reliance on the coupon card.

    在牛皮癬指徵下,總額與淨額的問題並不大,但團隊在 PBM 添加方面做出了非凡的貢獻,不僅增加了大量生命,而且由於使用量減少和對優惠券的依賴,還降低了總額與淨額的範圍。

  • So I think overall, if the volume where it needs to be, get a better gross to net picture, invest in expansion of the sales force as well as DTC and I feel really good about the second half of the year, especially how we exited Q2.

    因此我認為總體而言,如果銷量達到了需要的水平,獲得了更好的毛利率和淨利率圖,投資於銷售隊伍的擴張以及 DTC,我對今年下半年感到非常滿意,特別是我們如何結束第二季度。

  • Now in regards to Nexplanon, yes, I mean, that's still working its way out in terms of planned parenthood and Medicaid. But we've got opportunities in Title X on funding or rather being on frozen in key states like Texas as well as California.

    現在關於 Nexplanon,是的,我的意思是,從計劃生育和醫療補助的角度來看,它仍在努力解決。但我們在第十條修正案中獲得了資金方面的機會,或者更確切地說,在德克薩斯州和加利福尼亞州等關鍵州凍結資金。

  • And remember, we launched the five-year duration indication by the end of this year. That will be a little bit of a small headwind in 2026, but then ultimately, it expands our ability for exclusivity and through 2029 with a five year indication.

    請記住,我們在今年年底推出了五年期限指示。這在 2026 年會是一個小小的阻力,但最終,它擴大了我們的獨家經營能力,並且到 2029 年會有五年的預期。

  • And it's -- I don't want to get into -- I can give a little soliloquy in terms of the issues on being able to try to continue to penetrate into this market. But what I can tell you is ex US is growing double-digit robustly. US continues to be a growth driver for us, but we just got to get through this year. We've got to launch the five year indication.

    而且──我不想深入討論──我只能就嘗試繼續滲透這個市場的問題發表一點獨白。但我可以告訴你的是,美國以外的地區正在強勁成長兩位數。美國繼續成為我們的成長動力,但我們必須度過今年。我們必須啟動五年計劃。

  • And I think all signals point to the fact that, okay, a little disruption in terms of federal funding, but we feel good about where we are in terms of the patient cohort, in terms of expanding and where we are, in terms of the performance year-to-date. We've got 6% growth year-to-date, which is very solid.

    我認為所有訊號都表明,聯邦資金方面確實出現了一些中斷,但我們對患者群體、擴張情況以及今年迄今為止的表現感到滿意。今年迄今為止,我們的成長率已達到 6%,這是非常穩健的。

  • Jennifer Halchak - Vice President, Head of Investor Relations

    Jennifer Halchak - Vice President, Head of Investor Relations

  • Thanks, Ethan.

    謝謝,伊森。

  • Operator

    Operator

  • Jason Gerberry with Bank of America.

    美國銀行的 Jason Gerberry。

  • Jason Gerberry - Analyst

    Jason Gerberry - Analyst

  • Hey guys, thanks for, squeezing me in. So maybe firstly on the 621-9 endometriosis setback announced in July, just do you still expect to invest in the space? I think there was some commentary, in the lead up to that read out that there was a backup molecule and and if you saw at least a signal with 619, you might pursue that. So I'm just kind of curious where things may stand on that front.

    嘿夥計們,謝謝你們讓我加入。那麼,首先,關於 7 月宣布的 621-9 子宮內膜異位症挫折,您是否仍打算在該領域進行投資?我認為在那之前有一些評論說有一個備用分子,如果你至少看到一個 619 的訊號,你可能會追蹤它。所以我只是有點好奇這方面的情況如何。

  • And then, secondly, I know there was some effort through citizen's petition to modify the, generic product specific guidance for developing a generic and expert on more around the applicator similarity. But I'm curious, when you get the five-year approval, do you expect the FDA to have the.

    其次,我知道透過公民請願做出了一些努力來修改通用產品的具體指導,以開發通用產品並更多地關注塗抹器的相似性。但我很好奇,當你獲得五年批准時,你是否期望 FDA 能夠批准。

  • The real-time release study updated to mandatory five years or do you think there's still be an option to have a three year and a five-year release time or I guess time release study to be done by the generic supplier. Just curious your thoughts on that. Thanks.

    即時發布研究已更新為強制性的五年,或者您認為仍然可以選擇三年和五年的發佈時間,或者我猜想時間發布研究將由仿製藥供應商完成。只是好奇你對此的想法。謝謝。

  • Kevin Ali - Chief Executive Officer, Director

    Kevin Ali - Chief Executive Officer, Director

  • Juan Camilo, would you like to take that, those questions?

    胡安·卡米洛,您願意回答這些問題嗎?

  • Juan Camilo Arjona Ferreira - Head of R&D

    Juan Camilo Arjona Ferreira - Head of R&D

  • Yeah, I can handle both, Kevin. Yes. So first, regarding the 6219 as we shared in our press release, we did not see a signal for efficacy for 609. And therefore, to your question on the back of molecule in the second asset, which was targeting the same mechanism. We have decided to discontinue that program as well.

    是的,我可以處理兩者,凱文。是的。首先,關於 6219,正如我們在新聞稿中分享的那樣,我們沒有看到 609 個有效的訊號。因此,對於您關於第二個資產中分子背面的問題,其針對的是相同的機制。我們也決定停止該計劃。

  • And now second with regard to the Citizen's petition and on the overall FDA guidance, we don't comment on the decisions the FDA may make about their guidance on how to develop a generic. We are working closely with the FDA to get the right labeling for the five year indication in Nexplanon. And as you saw in the sites position we provided our perspective of what is required and has been required for Nexplanon to be used with safely in patients.

    其次,關於公民請願書和 FDA 的整體指導,我們不對 FDA 就如何開發仿製藥的指導做出的決定發表評論。我們正在與 FDA 密切合作,以獲得 Nexplanon 五年適應症的正確標籤。正如您在網站立場中看到的,我們提供了我們對 Nexplanon 在患者身上安全使用的要求和要求的看法。

  • So with that information, the FDA will make their own assessment under timing, what is the right appropriate guidance it will provide to generic manufacturers. But we are -- as Kevin pointed out, we're really excited looking forward to bringing this new indication and the new labeling for next on through the finish line before the end of the year.

    因此,有了這些訊息,FDA 將根據時間安排做出自己的評估,確定為仿製藥製造商提供正確、適當的指導。但是,正如凱文指出的那樣,我們非常高興地期待在年底之前將這一新適應症和新標籤推向終點。

  • Jason Gerberry - Analyst

    Jason Gerberry - Analyst

  • Okay.

    好的。

  • Kevin Ali - Chief Executive Officer, Director

    Kevin Ali - Chief Executive Officer, Director

  • What I will say, though, is that patients and providers, both clearly prefer the longer duration of five years, just give them much more flexibility especially for different segments, like, for example, the Family complete segment, the older cohort in terms of -- because a lot of our business comes with a much younger cohort. And so this will open up a completely new segment for us.

    不過,我想說的是,患者和提供者都明顯更喜歡五年的較長期限,這給了他們更多的靈活性,特別是對於不同的細分市場,例如家庭完整細分市場、年齡較大的群體——因為我們的許多業務都來自更年輕的群體。這將為我們開闢一個全新的領域。

  • And so to the question of can we see a three year and a five year coexisting in the market? Very difficult. I think by the time that that all plays out. I think the market will have moved securely into the five year segment, just another hurdle to -- essentially for any potential generics to actually deal with in managing to get into this business.

    那麼,我們能否看到三年期和五年期在市場上共存?非常困難。我認為到那時一切都會結束。我認為市場將安全進入五年期市場,對於任何潛在的仿製藥企業來說,這實際上只是進入該行業時需要應對的另一個障礙。

  • Jason Gerberry - Analyst

    Jason Gerberry - Analyst

  • Yeah, okay, thanks guys.

    是啊,好的,謝謝大家。

  • Operator

    Operator

  • Sure. Thanks, Jason. This concludes the question-and-answer session and will conclude today's conference call and webcast. Thank you for joining. You may now disconnect.

    當然。謝謝,傑森。問答環節到此結束,今天的電話會議和網路直播也將結束。感謝您的加入。您現在可以斷開連線。