Organon & Co (OGN) 2024 Q3 法說會逐字稿

Thank you for standing by. My name is Mandeep and I'll be your operator today. At this time, I'd like to welcome everyone to the Organon Q3 2024 earnings call and webcast. (Operator Instructions) I would now like to turn the call over to Jennifer Halchak, Vice President, Investor Relations. You may begin.

謝謝你的支持。我叫 Mandeep，今天我將擔任您的接線生。此時，我謹歡迎大家參加 Organon 2024 年第三季財報電話會議和網路廣播。（操作員指示）我現在想將電話轉給投資者關係副總裁 Jennifer Halchak。你可以開始了。

Thank you, operator. Good morning, everyone. Thank you for joining Organon's third-quarter 2024 earnings call. With me today are Kevin Ali, Organon's Chief Executive Officer; and Matt Walsh, our Chief Financial Officer, as well as Juan Camilo Arjona Ferreira, Organon's Head of R&D.

謝謝你，接線生。大家早安。感謝您參加 Organon 2024 年第三季財報電話會議。今天與我在一起的有 Organon 執行長 Kevin Ali；我們的財務長 Matt Walsh 以及 Organon 的研發主管 Juan Camilo Arjona Ferreira。

Today, we'll 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.

今天，我們將引用一個演示文稿，該演示文稿將在本次電話會議期間在我們的網路廣播中為大家展示。本次電話會議之後，我們還將在我們的 Organon 投資者關係網站 www.organon.com 的活動和演示部分提供此演示文稿。

Before we begin, I would like to caution listeners that certain information discussed by management during this conference call will include forward-looking statements. 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 Commission including our 10-K and subsequent periodic filings.

在我們開始之前，我想提醒聽眾，管理階層在本次電話會議中討論的某些資訊將包含前瞻性陳述。由於與公司業務相關的風險和不確定性，實際結果可能與前瞻性陳述中明示或暗示的結果有重大差異，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（包括我們的10 -K 和後續定期文件）中進行了討論。

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 reconciliation of these non-GAAP measures to the comparable GAAP measures is included in the press release and conference call presentation. I'd now like to turn the call over to our CEO, Kevin Ali.

此外，我們將在本次電話會議上討論某些非公認會計原則財務措施，這些措施應被視為根據公認會計原則準備的財務措施的補充，而不是替代。新聞稿和電話會議簡報中包含了這些非公認會計準則衡量指標與可比較公認會計準則衡量指標的對照表。我現在想將電話轉給我們的執行長凱文·阿里。

Good morning, everyone. And thank you, Jen. Welcome to today's call where we'll talk about our third quarter results. For the third quarter of 2024, revenue was $1.6 billion, representing a 5% growth rate of constant currency. The women's health franchise grew 6%. Our biosimilars franchise grew 17% and our established brands franchise was up 3%.

大家早安。謝謝你，珍。歡迎參加今天的電話會議，我們將討論我們的第三季業績。2024 年第三季營收為 16 億美元，以固定匯率計算成長率為 5%。女性健康業務成長了 6%。我們的生物相似藥特許經營權成長了 17%，我們的知名品牌特許經營權成長了 3%。

Adjusted EBITDA was $459 million representing a 29% adjusted EBITDA margin. Adjusted EBITDA includes $51 million of IPR&D expense booked in the third quarter worth approximately 320 basis points of margin in the quarter. Year to date, we have generated nearly $700 million of free cash flow and are well on track to deliver our commitment of approximately $1 billion of free cash flow before one-time costs in 2024.

調整後 EBITDA 為 4.59 億美元，調整後 EBITDA 利潤率為 29%。調整後的 EBITDA 包括第三季登記的 5,100 萬美元 IPR&D 費用，相當於該季度利潤率約 320 個基點。今年迄今為止，我們已產生近 7 億美元的自由現金流，並有望兌現 2024 年在一次性成本之前實現約 10 億美元自由現金流的承諾。

Our significant free cash flow enables us to comfortably service the dividend and still gives us capacity to invest in high potential assets. Given our view into the rest of the year, we raised the midpoint of our revenue guidance by $50 million to reflect performance year to date and improve view of foreign exchange. The guidance represents growth of 1.8% to 2.6% on a nominal basis and 3.1% to 3.8% [FX] change for the full year.

我們大量的自由現金流使我們能夠輕鬆支付股息，並且仍然使我們有能力投資高潛力資產。鑑於我們對今年剩餘時間的看法，我們將收入指導的中點上調了 5000 萬美元，以反映年初至今的業績並改善對外匯的看法。該指引代表名義成長 1.8% 至 2.6%，全年 [FX] 變化 3.1% 至 3.8%。

That would represent our third consecutive year of constant currency revenue growth driven by strong performance in Nexplanon, biosimilars, Jada, and the addition of Emgality. Further, while it's too soon to be guiding to 2025 on this call, at this point in our planning cycle for next year, we believe that organic growth drivers plus contribution from recent business development will support another year of constant currency revenue growth in 2025.

這將代表我們在 Nexplanon、生物仿製藥、Jada 和 Emgality 的強勁表​​現的推動下連續第三年實現貨幣收入恆定增長。此外，雖然現在就本次電話會議對2025 年進行指導還為時過早，但在我們明年規劃週期的此時點，我們相信有機增長動力加上近期業務發展的貢獻將支持2025 年貨幣收入的又一個持續成長。

We're also revising our full-year 2024 adjusted EBITDA margin range. The new range is 30% to 31%. Matt will walk you through that bridge, which factors in $51 million of IPR&D in the third quarter.

我們也修改了 2024 年全年調整後 EBITDA 利潤率範圍。新的範圍是 30% 到 31%。Matt 將帶您走過這座橋樑，其中包括第三季 5,100 萬美元的智慧財產權與研發 (IPR&D)。

In addition to reporting our results today, we are able to share more about our Dermavant acquisition and its key asset, VTAMA, which we closed on Monday. VTAMA is a nonsteroidal topical cream already approved for the treatment of plaque psoriasis in adult patients.

除了今天報告我們的業績外，我們還可以分享更多有關我們週一完成的 Dermavant 收購及其關鍵資產 VTAMA 的資訊。VTAMA 是一種非類固醇外用乳膏，已被批准用於治療成年患者的斑塊狀乾癬。

VTAMA also has a [Q4 PDUFA] for potential new indication, the topical treatment of atopic dermatitis in adults and pediatric patients two years of age and older. The near-term potential for the proposed atopic dermatitis indication is the much more attractive opportunity for us for two main reasons.

VTAMA 還有一個 [Q4 PDUFA]，用於潛在的新適應症，即成人和兩歲及以上兒童患者異位性皮膚炎的局部治療。由於兩個主要原因，擬議的異位性皮膚炎適應症的近期潛力對我們來說是更具吸引力的機會。

First, the size of the market. There are three times as many patients suffering from atopic dermatitis as compared to psoriasis. And second, for those millions of patients, if approved, we believe VTAMA can address an existing gap in the standard of care for atopic dermatitis. There's a significant unmet need in atopic dermatitis for the treatment option with the efficacy of a biologic and with the safety and tolerability profile of a topical treatment that can be used long term.

第一，市場規模。患有異位性皮膚炎的患者數量是牛皮癬患者的三倍。其次，對於這數百萬患者來說，如果獲得批准，我們相信 VTAMA 可以解決異位性皮膚炎護理標準中現有的差距。異位性皮膚炎對具有生物製劑功效以及可長期使用的局部治療的安全性和耐受性的治療選擇存在顯著的未滿足需求。

This point is especially important as nearly half of all atopic dermatitis sufferers are children. Because of this unique clinical profile, we believe VTAMA will be much better positioned in the atopic dermatitis market than it ever was in the psoriasis market.

這一點尤其重要，因為近一半的異位性皮膚炎患者是兒童。由於這種獨特的臨床特徵，我們相信 VTAMA 在異位性皮膚炎市場的定位將比在銀屑病市場的定位要好得多。

In fact, in our view, the opportunity for VTAMA in AD versus psoriasis is night and day. So what is it about the clinical profile that is so differentiating? We have with us today, Juan Camilo, our Head of R&D to talk more specifically on that topic.

事實上，我們認為 VTAMA 治療 AD 與乾癬的機會是日夜兼程的。那麼，臨床特徵為何如此與眾不同呢？今天，我們的研發主管胡安·卡米洛 (Juan Camilo) 將與我們一起更具體地討論這個主題。

Thank you, Kevin. I'd like to expand on Kevin's point about how VTAMA is much better situated in the atopic dermatitis market than in psoriasis. Psoriasis is a systemic autoimmune disease that more frequently benefits from systemic therapy and patients can be well-controlled with injectable biologics.

謝謝你，凱文。我想進一步闡述 Kevin 的觀點，即 VTAMA 在異位性皮膚炎市場的定位比在牛皮癬市場的定位要好得多。乾癬是一種系統性自體免疫疾病，更常受益於全身性治療，並且透過注射生物製劑可以很好地控制患者。

In fact, at the time of the time of launch, the psoriasis market was already fairly saturated with biologics. Therefore, there wasn't a critical unmet need like there is today in atopic dermatitis.

事實上，在推出時，牛皮癬市場的生物製劑已經相當飽和。因此，不存在像今天異位性皮膚炎那樣的未滿足的關鍵需求。

Atopic dermatitis, on the other hand, is a chronic long-lasting disease characterized by inflammation, redness, and irritation of the skin that is best addressed with a topical solution. During a flare, atopic dermatitis can be highly symptomatic and itchiness associated with it can be so severe, it may even affect sleep.

另一方面，異位性皮膚炎是一種慢性長期疾病，其特徵是皮膚發炎、發紅和刺激，最好用局部溶液來治療。在發作期間，異位性皮膚炎可能會出現嚴重症狀，與之相關的搔癢可能非常嚴重，甚至可能影響睡眠。

Despite the significant disease burden associated with AD, there has not been a lot of innovation. The existing topical treatments are mostly steroids, which were first available in the 1950s and are not intended for chronic use.

儘管 AD 帶來了巨大的疾病負擔，但並沒有太多的創新。現有的局部治療主要是類固醇，首次出現於 20 世紀 50 年代，不適合長期使用。

Current [non-steroidal] options for AD consist of a few agents that have demonstrated different levels of efficacy, one being a highly priced injectable biologic and another, a JAK inhibitor where there's a black box warning. There is need for a solution that is efficacious like the biologics and with the safety and tolerability profile that is suitable for long-term use in adults and children.

目前治療 AD 的[非類固醇]藥物包括幾種已表現出不同水平療效的藥物，其中一種是高價的注射生物製劑，另一種是 JAK 抑製劑，其中有黑框警告。需要一種像生物製劑一樣有效且具有適合成人和兒童長期使用的安全性和耐受性的解決方案。

The results from the two Phase III clinical trials support our view that the time it has the potential to fill this gap. Pending FDA approval, our proposed label for VTAMAs abroad, potentially covering mild to severe AD with no restrictions for use or limitations of body surface area, with a high rate of treatment response in children greater than two years of age and adults and good tolerability.

兩項III期臨床試驗的結果支持了我們的觀點，即它有潛力填補這一空白。我們在國外擬定的 VTAMA 標籤正在等待 FDA 批准，可能涵蓋輕度至重度 AD，無使用限製或體表面積限制，在兩歲以上兒童和成人中治療反應率高，且耐受性良好。

Our proposed label would be truly different to the label of other options in the market. So we are confident in the clinically different profile of VTAMA for the treatment of atopic dermatitis. And we're excited to bring this novel option to the patients who have been suffering from this condition and their healthcare providers who will no longer have to make trade-offs between efficacy and safety if VTAMA is approved.

我們提議的標籤將與市場上其他選項的標籤真正不同。因此，我們對 VTAMA 治療異位性皮膚炎的臨床差異充滿信心。我們很高興為患有這種疾病的患者及其醫療保健提供者帶來這種新穎的選擇，如果 VTAMA 獲得批准，他們將不再需要在療效和安全性之間進行權衡。

Thank you, Juan Camilo. So we're talking about a treatment option that is clinically differentiated in a large market with a critical unmet need. That combination makes us very confident in the commercial positioning for VTAMA in atopic dermatitis, if approved.

謝謝你，胡安·卡米洛。因此，我們正在討論一種在臨床上具有差異化的治療方案，該治療方案在一個具有嚴重未滿足需求的大型市場中。如果獲得批准，這種組合使我們對 VTAMA 在異位性皮膚炎中的商業定位非常有信心。

And from a capital allocation standpoint, this transaction makes a lot of sense for Organon. The terms of the transaction are very attractive with the economic skewed disproportionately towards success-based milestones. We expect to achieve at least $150 million of sales of VTAMA in 2025, with the potential to grow to $0.5 billion over the next three to five years.

從資本配置的角度來看，這筆交易對 Organon 來說意義重大。交易條款非常有吸引力，因為經濟不成比例地偏向基於成功的里程碑。我們預計 2025 年 VTAMA 的銷售額將至少達到 1.5 億美元，並有可能在未來三到五年內成長到 5 億美元。

In 2025, we expect the transaction to be dilutive to our EBITDA margin by about 50 basis points, and we expect the transaction to be accretive in year two with earnings accelerating from there. The acquisition also nicely leverages Organon's existing therapeutic expertise in dermatology.

到 2025 年，我們預計該交易將稀釋我們的 EBITDA 利潤率約 50 個基點，並且我們預計該交易將在第二年實現增值，盈利將加速增長。此次收購也很好地利用了 Organon 現有的皮膚病治療專業知識。

Our existing dermatology portfolio of seven products outside the US delivered $240 million of revenues in 2023. The addition of VTAMA allows us to create a dermatology presence in the US where we have a very experienced and scaled access team at the local state and national levels.

我們在美國以外現有的由七種產品組成的皮膚科產品組合到 2023 年將帶來 2.4 億美元的收入。VTAMA 的加入使我們能夠在美國建立皮膚科業務，在當地州和國家層面擁有一支經驗豐富且規模龐大的進入團隊。

We expect to be in a position to launch the AD indication immediately after approval, focused on expanding access, ultimately improving VTAMA's gross to net over time. We'll also have the potential to launch internationally down the road. Overall, we believe we are the best owner of VTAMA with solid growth prospects and healthy margins. We believe it will contribute solidly to the financial profile of Organon.

我們預計能夠在獲得批准後立即啟動 AD 適應症，重點是擴大進入範圍，最終隨著時間的推移提高 VTAMA 的毛淨值。我們也將有潛力在國際上推出。總體而言，我們相信我們是 VTAMA 的最佳所有者，擁有穩健的成長前景和健康的利潤率。我們相信這將對 Organon 的財務狀況做出重大貢獻。

So let's review the rest of the business in greater detail. Growth in women's health was driven by continued strength in Nexplanon which was up 11% ex-FX in the third quarter. In the US, Nexplanon grew 18% in the third quarter. We benefited from Nexplanon's leadership in the US contraception market, our pricing strategy, including management of the 340B discount program, as well as continued physician demand growth outside the US.

那麼讓我們更詳細地回顧一下其餘的業務。Nexplanon 的持續強勁推動了女性健康的成長，第三季扣除外匯因素後成長了 11%。在美國，Nexplanon 第三季成長了 18%。我們受惠於 Nexplanon 在美國避孕市場的領導地位、我們的定價策略（包括 340B 折扣計劃的管理）以及美國以外醫生需求的持續增長。

Nexplanon was down 3% ex-FX in the third quarter, primarily due to the timing of tenders in Latin America. Given strong year-to-date performance, we expect Nexplanon can achieve constant currency full-year revenue growth in the low to mid teens. This would be our best year yet with Nexplanon and positions us extremely well to achieve the $1 billion milestone that we had signaled for the next year.

Nexplanon 第三季扣除外匯因素後下跌 3%，這主要是由於拉丁美洲的招標時間安排所致。鑑於今年迄今的強勁表現，我們預計 Nexplanon 能夠實現全年匯率穩定的營收成長。今年將是我們與 Nexplanon 合作以來表現最好的一年，並使我們非常有能力實現我們在明年承諾的 10 億美元的里程碑。

We remain very optimistic about Nexplanon's future prospects and the expanding potential of the brand through the proposed five-year indication. We plan on making our submission to the FDA in the next few months, which would put us in a position to be ready for our late 2025 launch, assuming FDA approval.

我們對 Nexplanon 的未來前景以及該品牌透過擬議的五年指標不斷擴大的潛力仍然非常樂觀。我們計劃在接下來的幾個月內向 FDA 提交申請，如果獲得 FDA 批准，這將使我們能夠為 2025 年末的上市做好準備。

Moving on to other women's health. Though up 14% ex-FX in the third quarter, we expect our fertility business to be slightly down this year as we work through inventory adjustments related to exiting a spin-related interim operating model and onboarding a large PBM contract in the US in the fourth quarter of last year.

繼續關注其他女性的健康。儘管第三季扣除外匯因素增加了 14%，但我們預計今年的生育業務將略有下降，因為我們正在進行與退出旋轉相關的臨時營運模式以及在美國簽訂大型 PBM 合約相關的庫存調整。第四季。

We see 2025 as the rebound year with very strong growth for fertility underpinned by continuing ART-expanded reimbursement in China, international expansion, and performance in the US that won't have the noise of the IOM exit.

我們認為 2025 年將是反彈之年，生育率將強勁增長，這得益於中國繼續擴大 ART 報銷範圍、國際擴張以及美國的表現，不會受到 IOM 退出的影響。

Let's move now to our biosimilars franchise, which grew 17% at constant currency in the third quarter. We expect biosimilars to deliver low-teens growth for the full year 2024, with Renflexis and Ontruzant at the mature point in their unusually long and impressive growth period.

現在讓我們來看看我們的生物相似藥特許經營權，按固定匯率計算，該特許經營權在第三季度增長了 17%。我們預計生物相似藥將在 2024 年全年實現低雙位數成長，其中 Renflexis 和 Ontruzant 在其異常漫長且令人印象深刻的增長期中處於成熟點。

Biosimilars growth next year will be driven by continued uptake of Hadlima in the US, which has performed well and continues to grow sequentially. The strategy in biosimilars is to launch a new asset every couple of years. In late 2025 and beyond, additional growth contributors to the biosimilars franchise will be the denosumab asset, then later the pertuzumab asset. Both will be launched in collaboration with Shanghai Henlius, pending FDA review and approval.

明年生物相似藥的成長將受到美國 Hadlima 的持續吸收的推動，該藥物表現良好並繼續連續成長。生物相似藥的策略是每幾年推出新資產。2025 年底及以後，生物相似藥系列的額外成長貢獻者將是狄諾塞麥資產，然後是帕妥珠單抗資產。兩者都將與上海復宏漢霖合作推出，目前正在等待 FDA 批准。

Just yesterday, we announced that the FDA accepted our biologics license application for the denosumab asset, bringing us a step closer to potentially providing this treatment option to patients in the US in 2025. And then rounding out our discussion with established brands, which grew 3% ex-FX in the third quarter and up 1% ex-FX year to date.

就在昨天，我們宣布 FDA 接受了我們對狄諾塞麥資產的生物製劑許可申請，​​這使我們距離 2025 年向美國患者提供這種治療選擇又近了一步。然後完善我們與知名品牌的討論，這些品牌第三季的除外匯外成長了 3%，年初至今成長了 1%。

We expect the franchise to deliver flat to slightly better performance on a full-year basis as growth in Emgality and the recovery of injectable steroids are expected to offset the LOE of Atozet and mandatory pricing revisions in Japan. Overall, we are very encouraged about our performance year to date and remain very confident in our ability to deliver on our commitments for the full year.

我們預計該特許經營權全年業績將持平或略好，因為 Emgality 的成長和注射類固醇的復甦預計將抵消 Atozet 的 LOE 和日本的強制性定價調整。總體而言，我們對今年迄今為止的表現感到非常鼓舞，並對我們履行全年承諾的能力充滿信心。

I'll now turn it over to Matt, who will discuss our financial performance in greater detail.

我現在將其交給馬特，他將更詳細地討論我們的財務表現。

Thank you, Kevin. Beginning on slide 9. Here, we bridge revenue for the third quarter year over year. As Kevin mentioned at the outset, third quarter revenue of $1.58 billion was up 4% over third quarter of last year and ahead 5% at constant currency.

謝謝你，凱文。從投影片 9 開始。在這裡，我們將第三季的營收與去年同期相比。正如 Kevin 在開頭提到的，第三季營收為 15.8 億美元，比去年第三季成長 4%，以固定匯率計算成長 5%。

Impact from LOE was about $5 million in the quarter, which reflects the loss of exclusivity of Atozet in Japan, a negligible impact from the beginnings of the Atozet LOE in Europe, which happened in September. We didn't have any meaningful VBP headwind in the third quarter as the effects of Round 8 that began in the third quarter of last year and included Remeron and Hyzaar are now washing out.

本季 LOE 的影響約為 500 萬美元，這反映了 Atozet 在日本的獨家經營權的喪失，與 9 月發生的 Atozet LOE 在歐洲開始的影響可以忽略不計。我們在第三季度沒有遇到任何有意義的 VBP 逆風，因為去年第三季開始的第 8 輪（包括 Remeron 和 Hyzaar）的影響現在正在消失。

There was an approximate $70 million impact from price in the third quarter or about 4.6%. You may recall that in our second quarter call, we said that the back half of 2024 would face steeper headwinds from price than the first half due to the timing of mandatory pricing reductions in Japan, mainly in the cardio and respiratory portfolios, which is what we are see.

第三季價格影響約為 7,000 萬美元，即 4.6% 左右。您可能還記得，在我們第二季的電話會議中，我們表示，由於日本強制降價的時機，主要是有氧運動和呼吸系統產品組合，因此2024 年下半年將面臨比上半年更大的價格阻力。

We're also seeing pricing headwind coming from the September LOE of Atozet in Spain and France as well as from certain mature products in the US like NuvaRing, Dulera, and Renflexis. Volume growth in the quarter was $150 million or almost 10% across several drivers. Hadlima and Emgality were the largest contributors to volume growth, followed by fertility, Nexplanon, and established brands, especially in China.

我們也看到來自西班牙和法國 Atozet 9 月 LOE 以及美國某些成熟產品（如 NuvaRing、Dulera 和 Renflexis）的定價逆風。本季銷量成長達 1.5 億美元，在多個驅動因素中幾乎成長了 10%。Hadlima 和 Emgality 是銷量成長的最大貢獻者，其次是 Fertility、Nexplanon 和知名品牌，尤其是在中國。

Timing of tenders of Ontruzant and NuvaRing in the US were the biggest offsets to volume growth. In supply or other, here, we captured the lower margin contract manufacturing arrangements that we have with Merck, which had been declining since the spin-off as expected, although there was only a small change year over year in this bucket this quarter.

Ontruzant 和 NuvaRing 在美國的招標時機是對銷售成長的最大抵銷。在供應或其他方面，我們與默克公司簽訂的合約製造安排的利潤率較低，自分拆以來，合約製造安排的利潤率一直在下降，正如預期的那樣，儘管本季度這一方面與去年同期相比只有很小的變化。

Then lastly, foreign exchange translation had an approximate $20 million impact or 130 basis points of headwind to revenue, which reflects the strengthening US dollar versus certain foreign currencies, which this quarter included the Mexican peso, Japanese yen, and Brazilian real.

最後，外匯換算對收入產生了約 2,000 萬美元的影響或 130 個基點的阻力，這反映了美元兌某些外幣的走強，本季包括墨西哥比索、日圓和巴西雷亞爾。

Now, let's turn to slide 10, where we show key non-GAAP P&L line items and metrics for third-quarter performance. 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.

現在，讓我們轉向投影片 10，其中顯示了關鍵的非 GAAP 損益項目和第三季業績指標。作為參考，我們的新聞稿和本簡報附錄中的投影片中包含了 GAAP 財務數據和非 GAAP 財務指標的調整表。

For gross profit, we are excluding from cost of goods, purchased accounting amortization, and one-time items which can be seen in our appendix slides. Adjusted gross margin was 61.7% in the third quarter of 2024 compared with 62.6% in the third quarter of last year.

對於毛利，我們不包括商品成本、採購會計攤銷和一次性項目，這些可以在我們的附錄幻燈片中看到。2024年第三季調整後毛利率為61.7%，去年第三季為62.6%。

In the third quarter of 2024, the lower adjusted gross margin was primarily related to unfavorable product mix and price. Excluding $51 million of IPR&D expense incurred during the period, non-GAAP operating expenses were down 5% year over year, reflective of our cost containment efforts. Of the $51 million of IPR&D expense in the third quarter, virtually all of it related to our collaboration with Shanghai Henlius for further advancement of the denosumab and pertuzumab biosimilar candidates.

2024年第三季度，調整後毛利率較低主要與不利的產品結構和價格有關。排除期內產生的 5,100 萬美元的智慧財產權與研發費用，非公認會計準則營運費用年減 5%，這反映了我們在成本控制方面所做的努力。在第三季 5,100 萬美元的 IPR&D 費用中，幾乎所有費用都與我們與上海復宏漢霖合作進一步推進地諾單抗和帕妥珠單抗生物相似藥候選藥物有關。

While we have an established practice of not guiding to IPR&D, we do have pretty good line of sight from now until the end of 2024. We don't expect to surpass any further milestones that would trigger IPR&D payments. While the total of $81 million of IPR&D expense for the full year represents a headwind of about 170 basis points year to date, these payments are strong signals that our pipeline is progressing, and we are building our ability to sustain revenue growth well into the future.

雖然我們有不指導智慧財產權和研發的既定做法，但從現在到 2024 年底，我們確實有相當好的視野。我們預計不會再超越任何會觸發 IPR&D 付款的里程碑。雖然全年 IPR&D 費用總額為 8,100 萬美元，較今年迄今下降了約 170 個基點，但這些付款強烈表明我們的管道正在取得進展，並且我們正在增強未來維持收入成長的能力。

These factors culminated in an adjusted EBITDA margin of 29% in the third quarter of 2024 compared with 29.4% in the third quarter of 2023. Non-GAAP adjusted net income was $226 million or $0.87 per diluted share, almost equal with 2023's $223 million or $0.87 per share in the same period.

這些因素最終導致 2024 年第三季調整後 EBITDA 利潤率為 29%，而 2023 年第三季為 29.4%。非 GAAP 調整後淨利為 2.26 億美元，即每股攤薄收益 0.87 美元，幾乎與 2023 年同期的 2.23 億美元，即每股 0.87 美元持平。

GAAP net income was actually higher than non-GAAP net income this quarter. GAAP net income benefited from the release of evaluation allowance in the amount of $210 million against the tax asset of one of the company's Swiss entities. In this development, while favorable, does not impact our non-GAAP effective tax rate for earnings guidance purposes, which remains in the range of 18.5% to 20.5%.

本季度 GAAP 淨利潤實際上高於非 GAAP 淨利潤。GAAP 淨利潤受益於針對該公司瑞士實體之一的稅務資產發放的 2.1 億美元評估津貼。這項進展雖然有利，但不會影響我們用於獲利指導目的的非公認會計原則有效稅率，該稅率仍保持在 18.5% 至 20.5% 的範圍內。

Turning to slide 11, we provide a closer look at our cash flow year to date, and despite some minor headwinds from the Dermavant acquisition as Kevin mentioned, we're well on track to deliver approximately $1 billion of free cash flow before one-time charges.

轉向幻燈片 11，我們更仔細地審視了今年迄今為止的現金流，儘管正如 Kevin 提到的那樣，收購 Dermavant 帶來了一些小阻力，但我們預計將一次性交付約 10 億美元的自由現金流收費。

Year to date, those one-time spin-related costs were $137 million. Our global ERP implementation is now behind us, and that was the largest driver of these one-time costs. Our view into the fourth quarter is that cost in this category will be minimal. So we expect to finish the year at approximately $150 million, which is better than the $200 million of one-time spin-related costs that we were originally forecasting for 2024.

今年迄今為止，這些一次性旋轉相關成本為 1.37 億美元。我們的全球 ERP 實施現已落後，這是這些一次性成本的最大驅動因素。我們對第四季的看法是，這一類別的成本將是最低的。因此，我們預計今年結束時的成本約為 1.5 億美元，這比我們最初預測 2024 年的一次性旋轉相關成本為 2 億美元要好。

Next year, in 2025, we would expect one-time spin-related costs to be de minimis. In the $129 million of other one-time costs, here we captured headcount restructuring initiatives and manufacturing network optimization. The cash outlay for these network optimization costs have amounted to $44 million year to date, 2024.

明年，也就是 2025 年，我們預計一次性旋轉相關成本將降至最低。在 1.29 億美元的其他一次性成本中，我們捕獲了人員重組計劃和製造網路優化。2024 年迄今為止，這些網路優化成本的現金支出已達 4,400 萬美元。

They are distinct from the spin-related costs in that they're associated with actions to separate our manufacturing and supply chain activities away from Merck, which will ultimately drive cost efficiencies and eventual gross margin improvement. We expect this bucket to total about $75 million this year.

它們與旋轉相關成本不同，因為它們與將我們的製造和供應鏈活動從默克公司分離出來的行動有關，這最終將提高成本效率並最終提高毛利率。我們預計今年這一桶的總額約為 7500 萬美元。

Turning to slide 12. We ended the quarter at 4.0 times on our net leverage ratio, which was a quarter turn better than this time last year and also slightly better than where we were at year end, 4.1 times. Year to date, we have had stronger EBITDA generation, which has resulted in a leverage ratio at September 30, 2024, that is more favorable than our expectations at the start of the year.

轉到投影片 12。本季末，我們的淨槓桿率為 4.0 倍，比去年同期好四分之一，也略好於年底的 4.1 倍。今年迄今為止，我們的 EBITDA 生成能力更強，這導致截至 2024 年 9 月 30 日的槓桿率比我們年初的預期更為有利。

That said, it will take us several quarters to digest the Dermavant acquisition before leverage can return to the 4.0 times net leverage ratio that we've achieved as of this quarter end.

也就是說，我們需要幾個季度的時間來消化對 Dermavant 的收購，然後槓桿率才能恢復到我們截至本季末所實現的 4.0 倍淨槓桿率。

Now turning to 2024 guidance on slide 13, where we highlight the items driving our 2024 revenue guidance range. As Kevin mentioned, we've tightened our revenue range and raised the midpoint by $50 million, representing 1.8% to 2.6% nominal growth year on year, which equates to 3.1% to 3.8% on a constant currency basis.

現在轉向幻燈片 13 上的 2024 年指導，其中我們重點介紹了推動 2024 年收入指導範圍的項目。正如 Kevin 所提到的，我們收緊了收入範圍，並將中點提高了 5000 萬美元，相當於名義同比增長 1.8% 至 2.6%，相當於按固定匯率計算的 3.1% 至 3.8%。

For LOE, we lowered our range from $70 million to $90 million to $40 million to $50 million, which reflects slower uptake for generics for Atozet. Moving to the right, we lowered the range on VBP impact from the $30 million to $50 million to $15 million to $25 million, which similarly reflects a slight delay in realizing the full revenue impact of Round 8 for Remeron and Hyzaar.

對於 LOE，我們將範圍從 7,000 萬美元至 9,000 萬美元降低至 4,000 萬美元至 5,000 萬美元，這反映出 Atozet 仿製藥的採用速度較慢。向右移動，我們將 VBP 影響範圍從 3000 萬美元至 5000 萬美元降低到 1500 萬美元至 2500 萬美元，這同樣反映出 Remeron 和 Hyzaar 在實現第 8 輪全部收入影響方面略有延遲。

We've been doing a bit better on price year to date, so we lowered our view of pricing impact from $180 million to $200 million to $145 million to $155 million, representing an approximate 2.5 percentage point headwind versus prior year, which is in line with our longer-term expectations from price across our entire business.

今年迄今為止，我們在價格方面的表現有所好轉，因此我們將定價影響的看法從1.8 億美元至2 億美元下調至1.45 億美元至1.55 億美元，與上一年相比，阻力約為2.5個百分點，這與去年一致以及我們對整個業務價格的長期預期。

Sequentially, the impact from price has been and is expected to be more acute in the back half of 2024 as the mandatory pricing revisions in Japan accelerate and reductions in price associated with the Atozet LOE in the EU more fully materialize.

因此，隨著日本強制定價調整的加速以及歐盟 Atoze LOE 相關價格下調的全面落實，價格的影響預計將在 2024 年下半年更加嚴重。

Additionally, we're facing increasing competitive pressures in the US within mature products such as Dulera, Renflexis, and NuvaRing. For the year, we've narrowed and lowered the range on volume to $445 million to $465 million, down from $500 million to $600 million.

此外，我們在美國面臨 Dulera、Renflexis 和 NuvaRing 等成熟產品日益增長的競爭壓力。今年，我們將成交量範圍從 5 億美元至 6 億美元縮減至 4.45 億美元至 4.65 億美元。

The range for volume reflects an approximate 7% growth rate over last year, tempering down from the 9% volume growth rate we expected, and that's mainly attributable to a softer outlook in fertility for the year.

成交量範圍反映了去年約 7% 的成長率，低於我們預期的 9% 的成交量成長率，這主要是由於今年生育率前景疲軟。

And finally, based on our current view of FX, we lowered our view of FX impact to $75 million to $85 million, down from $110 million to $140 million, and that $50 million improvement is the principle driver for raising the midpoint of our revenue guide by $50 million. Kevin mentioned at the outset that we were also revising our range on adjusted EBITDA from 31% to 33% to 30% to 31%.

最後，根據我們目前對外匯的看法，我們將外匯影響的看法從1.1 億美元下調至1.4 億美元，從1.1 億美元下調至7,500 萬美元至8,500 萬美元，而5,000 萬美元的改善是提高我們收入指南中點的主要驅動力增加 5000 萬美元。凱文一開始就提到，我們也將調整後 EBITDA 的範圍從 31% 至 33% 修改為 30% 至 31%。

In slide 14, we bridge the items driving the change. The largest driver is the incremental $51 million of IPR&D expense we booked in the third quarter worth about 80 basis points of margin for the full year.

在投影片 14 中，我們將推動變革的專案連結起來。最大的推動因素是我們在第三季預訂的 5,100 萬美元增量智慧財產權與開發費用，相當於全年利潤率約 80 個基點。

Second, in our view into Q4 revenue, we can see that we'll likely have some unfavorable product mix worth about 50 basis points of gross margin on the full year. This is primarily related to certain products in our US portfolio that are subject to higher competitive pressure, Ontruzant, NuvaRing, and Dulera to be specific, where we are seeing some pricing pressure and unfavorable channel mix from this group of products, which are at the mature part of their growth cycle.

其次，從我們對第四季營收的看法來看，我們可能會出現一些不利的產品組合，導致全年毛利率下降約 50 個基點。這主要與我們美國產品組合中的某些產品面臨較高的競爭壓力有關，具體而言，Ontruzant、NuvaRing 和 Dulera，我們看到這組產品存在一些定價壓力和不利的管道組合，這些產品處於其生長週期的成熟部分。

While we have seen pressure year to date in our US fertility business, we see a fairly strong rebound next year when combined with the strong gross margin profile of VTAMA, these two items in tandem should serve as an offset to the margin pressure dynamic in our mature brands.

雖然我們今年迄今為止在美國生育業務中遇到了壓力，但我們預計明年將出現相當強勁的反彈，再加上 VTAMA 強勁的毛利率狀況，這兩項相結合應該可以抵消我們的利潤壓力動態。品牌。

The fourth column here represents two months of onboarding of Dermavant at their current expense rate. So no synergies yet reflected in this number. The last column represents a net productivity in the base business, and that bridges you to the new midpoint of the adjusted EBITDA margin range.

這裡的第四列代表了 Dermavant 以目前費用率入職兩個月的情況。因此，這個數字尚未反映出綜效。最後一欄代表基礎業務的淨生產力，它可以幫助您到達調整後的 EBITDA 利潤率範圍的新中點。

Turning now to slide 15, where we show all components of our earnings guidance. For full-year 2024 and consistent with the revenue commentary that we just discussed, we are revising our gross margin range from 61% to 63% to approximately 61.5%.

現在轉向投影片 15，我們在其中展示了獲利指引的所有組成部分。對於 2024 年全年，與我們剛剛討論的收入評論一致，我們正在將毛利率範圍從 61% 至 63% 修改至約 61.5%。

On SG&A expense, we tightened our range from $1.5 billion to $1.7 billion to $1.55 billion to $1.6 billion, $25 million better at the midpoint, driven by year-to-date favorability. For R&D, we tightened our range around the midpoint on the base R&D spend and adjusted for the incremental $51 million of IPR&D that we booked in the third quarter.

在 SG&A 費用方面，我們將範圍從 15 億美元至 17 億美元收緊至 15.5 億美元至 16 億美元，在年初至今的好感度的推動下，中間值提高了 2500 萬美元。對於研發，我們收緊了基礎研發支出中點附近的範圍，並根據第三季預訂的 5,100 萬美元增量智慧財產權進行了調整。

On a full-year basis, the year-to-date total of IPR&D expense is $81 million, and that's worth about 130 basis points of adjusted EBITDA margin using the midpoint of our guide.

以全年為基礎，年初至今的 IPR&D 費用總額為 8,100 萬美元，相當於我們指南中位數調整後 EBITDA 利潤率的約 130 個基點。

As Kevin said, it's too soon to be guiding to 2025. But directionally, we do expect to see revenue growth year on year. This includes organic growth across the portfolio, plus the $150 million -plus of revenue from Dermavant that Kevin referenced. Those will be offsetting factors to the Atozet LOE next year as well as any other challenges we believe we might see across the portfolio.

正如 Kevin 所說，現在指導 2025 年還為時過早。但從方向上看，我們確實預計收入將同比增長。這包括整個投資組合的有機成長，加上 Kevin 提到的 Dermavant 超過 1.5 億美元的收入。這些將抵消明年 Atozet LOE 的因素以及我們認為我們可能在整個投資組合中看到的任何其他挑戰。

We do expect the Dermavant acquisition to be dilutive to 2025 profitability, accretive in 2026, and thereafter. In 2025, we expect the operating expense for Dermavant will be about $180 million and we'll be focused on a successful launch of VTAMA in the atopic dermatitis indication for which we hope to receive approval this quarter, pending FDA approval.

我們確實預計 Dermavant 收購將稀釋 2025 年的獲利能力，並在 2026 年及之後增加。到 2025 年，我們預計 Dermavant 的營運費用約為 1.8 億美元，我們將專注於成功推出針對異位性皮膚炎適應症的 VTAMA，我們希望在本季度獲得批准，等待 FDA 批准。

About one-third of this operating expense is fixed and is in the form of onboarding Dermavant sales and marketing capabilities. The other two-thirds and promotional spend around the launch and other business support that will either naturally flex down after the AD launch or else become opportunities for further synergies.

大約三分之一的營運費用是固定的，並且以 Dermavant 銷售和行銷能力的培訓形式出現。另外三分之二是圍繞發布和其他業務支援的促銷支出，這些支出要么在廣告發布後自然減少，要么成為進一步協同效應的機會。

In 2025, directionally, we expect Dermavant to account for approximately 0.5 point of EBITDA margin headwind, which of course, we will be looking to see if we can offset with further expense discipline enacted across other parts of our business as we've been doing quite successfully this year.

到2025 年，我們預計Dermavant 將佔EBITDA 利潤率逆風的約0.5 個百分點，當然，我們將看看我們是否可以像我們一直在做的那樣，透過在我們業務的其他部分制定的進一步費用紀律來抵消這一影響今年相當成功。

In 2026, we expect to become VTAMA margins to grow to be above Organon's company average as revenue accelerates from the AD launch and synergies are realized and continue to grow from there.

到 2026 年，隨著 AD 推出帶來的收入加速以及協同效應的實現和持續增長，我們預計 VTAMA 的利潤率將增長至高於 Organon 公司的平均水平。

Closing out, in 2024, we set ourselves up to deliver a trifecta of growth, a revenue and EBITDA dollars, a leverage P&L [ex] milestones and $1 billion of free cash flow before one-time items. With three quarters of the year under our belt and two months left to go, we feel very good about our ability to deliver on that goal.

到 2024 年，我們的目標是實現三重成長：收入和 EBITDA 美元、槓桿損益表里程碑以及一次性專案之前 10 億美元的自由現金流。今年還有四分之三的時間，還有兩個月的時間，我們對實現這一目標的能力感到非常滿意。

With that, now let's turn the call over to questions and answers.

現在，讓我們將通話轉入問答環節。

(Operator Instructions) Balaji Prasad, Barclays.

（操作員指示）Balaji Prasad，巴克萊銀行。

Good morning and thank you for the questions. Firstly, on VTAMA, congratulations on the deal. Seems to be well laid out in terms of capital allocation. Could you comment on the current profitability or the EBITDA contribution from Dermavant? And maybe getting into next year, on the OpEx of $180 million, split it up until atopic dermatitis spend versus psoriasis spend?

早安，謝謝你的提問。首先，在 VTAMA 上，恭喜這筆交易。在資本配置方面似乎已經佈局良好。您能否評論一下 Dermavant 目前的盈利能力或 EBITDA 貢獻？也許進入明年，在 1.8 億美元的營運支出上，將其分成異位性皮膚炎支出與牛皮癬支出？

And second question is on Nexplanon. Probably a slightly more sensitive topic, but can you comment around the current political climate vis-a-vis LARCs and maybe more specifically business growth drivers from Nexplanon? Thank you.

第二個問題是關於 Nexplanon 的。可能是一個稍微敏感的話題，但您能否就當前 LARC 的政治氣候以及 Nexplanon 的業務成長驅動因素發表評論？謝謝。

Matt, you want to take the first?

馬特，你想拿第一名嗎？

Yes. So we've got two months of VTAMA included in our rest-of-year guidance for 2024. And so, it's nominal. I mean, we're looking at a revenue run rate of approximately $6 million per month and we're forecasting the same level of dilution in this stub period as we would be talking about for 2025. So that's the VTAMA piece.

是的。因此，我們在 2024 年剩餘時間的指導中包含了兩個月的 VTAMA。所以，它是名義上的。我的意思是，我們正在考慮每月約 600 萬美元的收入運行率，並且我們預測在此存根期間的稀釋程度與我們在 2025 年討論的相同水平。這就是 VTAMA 作品。

And Balaji, in regards to your question regarding Nexplanon, it's actually a very timely question. I just came back from meetings on The Hill in DC and on both sides of the aisle, I can tell you we obviously know there's going to be a new administration coming. And on both sides of the aisle, I think the issue around access to LARCs, access to contraception, with regards to women's health in general is not a threat at all.

Balaji，關於你關於 Nexplanon 的問題，這實際上是一個非常及時的問題。我剛從華盛頓國會山莊和兩黨的會議回來，我可以告訴你，我們顯然知道將會有一個新政府即將到來。對於兩黨來說，我認為關於獲得 LARC、獲得避孕藥具的問題，對於婦女的整體健康來說根本不是威脅。

As a matter of fact, I think on both sides, there's as a doubling down of sorts that nobody wants to kind of get into any kind of discussions around whether it's fertility or access to contraception in order to be able to address reproductive health-related issues. So that's strong.

事實上，我認為雙方都在加倍努力，沒有人願意參與任何關於生育或避孕的討論，以便能夠解決與生殖健康相關的問題。所以這很強大。

And then our Nexplanon business continues to go along very, very well in the US. We're a market leader in the contraception space, especially in terms of LARCs. And we see continued growth not only in terms of demand, but also in our 340Bbusiness is also growing with the federally qualified health centers. There's a great opportunity for us in the future.

然後我們的 Nexplanon 業務在美國繼續發展得非常非常好。我們是避孕領域的市場領導者，特別是在 LARC 方面。我們不僅看到需求的持續成長，而且我們的 340B 業務也在與聯邦合格的健康中心一起成長。未來我們有一個很好的機會。

So we'll reach $1 billion, which is faster than I anticipated. For Nexplanon globally, with US obviously driving a big portion of that -- for us next year for Organon. And that's our first kind of major blockbuster milestone for the product. And we see a lot of years ahead of it in terms of the runway.

所以我們將達到 10 億美元，這比我預期的要快。對於 Nexplanon 在全球範圍內的發展，美國顯然推動了其中很大一部分——對於我們明年的 Organon 來說。這是我們該產品的第一個重大里程碑。就跑道而言，我們看到它還領先很多年。

Thanks for the question.

謝謝你的提問。

David Amsellem, Piper Sandler.

大衛·阿姆塞勒姆，派珀·桑德勒。

Thanks. So just a couple for me. So now that you have some medical derm commercial infrastructure in place and this is a new therapeutic vertical. How are you thinking about leveraging that infrastructure over the long term by the acquisition of additional assets? How aggressive do you want to be?

謝謝。所以對我來說只有幾個。現在你已經有了一些醫學皮膚商業基礎設施，這是一個新的治療垂直領域。您如何考慮透過收購額外資產來長期利用該基礎設施？你想有多激進？

And is it just medical derm or are you aslo open to assets in medical aesthetics? And then with the acquisition of Dermavant, how does that change your thinking on capital deployment? Are you looking to get more aggressive on the M&A front, particularly in a lower rate environment?

它只是醫學皮膚還是您也對醫學美容資產持開放態度？那麼，隨著 Dermavant 的收購，您對資本部署的想法有何改變？您是否希望在併購方面更加積極主動，特別是在利率較低的環境下？

Just philosophically, how ae you thinking about things in the wake of the acquisition and in the context of a lower interest rate environment? Thank you.

就哲學而言，您在收購之後以及較低利率環境的背景下如何思考事情？謝謝。

Thanks, David. I can address those questions. First, in regards to bringing this new vertical in the US. We've always been very big fans of the VTAMA and Dermavant in terms of what -- where the opportunities are. I listed them out in my script in terms of the opportunities for atopic dermatitis.

謝謝，大衛。我可以回答這些問題。首先，關於將這個新的垂直領域引入美國。就機會所在而言，我們一直是 VTAMA 和 Dermavant 的忠實粉絲。我在劇本中列出了發生異位性皮膚炎的機會。

And so that continues to be something that we feel very, very enthusiastic and very bullish about. And this is a great product, and I think you saw the differentiation that Juan Camilo spoke to. It's a great position within the atopic dermatitis space in both the efficacy of a biologic, even potentially -- potentially, I'd say that greater and really well-tolerated for use for long periods of time.

因此，這仍然是我們感到非常非常熱情和非常樂觀的事情。這是一款很棒的產品，我想您已經看到了胡安·卡米洛談到的差異化。它在異位性皮膚炎領域處於一個很好的地位，無論是生物製劑的功效，還是潛在的功效，我想說的是，它的功效更大，並且對於長期使用具有良好的耐受性。

So really excited about that. And you're right, David. Over time, it definitely opens up a new opportunity for us. Now, keep in mind that we do have opportunities to internationalize VTAMA, so we'll be taking that path as soon as we can. We're going to be hopefully launching in Canada, that's the first country. We're on track for that in the not-too-distant future.

對此我真的很興奮。你是對的，大衛。隨著時間的推移，這無疑為我們帶來了新的機會。現在，請記住，我們確實有機會使 VTAMA 國際化，因此我們將盡快採取這條道路。我們希望在加拿大推出，這是第一個國家。我們將在不久的將來實現這一目標。

So that will be a nice addition to our portfolio, but also we'll be looking at other countries as well. We also have a royalty agreement in Japan. So we'll be getting royalties from that partnership as well. But within the US, definitely it opens up quite a bit of different opportunities that we see, a variety of different opportunities.

因此，這將是我們投資組合的一個很好的補充，但我們也會關注其他國家。我們在日本也有特許權使用費協議。因此，我們也將從該合作關係中獲得版稅。但在美國，它無疑帶來了我們所看到的許多不同的機會，各種不同的機會。

You mentioned a few of them, whether it's anti-infectives, all the way to aesthetics and everything in between. Look, the team that we are bringing over from Dermavant is top-notch, and we intend to essentially support them with all the different expertise we have, especially on the access front. We've got some of the best access folks that you know where we all came from.

你提到了其中的一些，無論是抗感染藥物，一直到美學以及介於兩者之間的一切。瞧，我們從 Dermavant 引進的團隊是一流的，我們打算用我們擁有的所有不同的專業知識來支持他們，特別是在訪問方面。我們擁有一些最優秀的接觸人員，您知道我們都來自哪裡。

And this is kind of on the regional local as well as state levels, as well as national levels that will help to really expand our opportunities, not only with VTAMA, but also establishing ourselves for the future in that derm space.

這在地區、州和國家層面上都將有助於真正擴大我們的機會，不僅是與 VTAMA 合作，而且還為我們在皮膚領域的未來奠定了基礎。

In regards to the future of capital allocation in terms of BD as well as where rates are going, I think right now our pure focus for 2025 will really be about integrating, as well as really driving the VTAMA performance, and then we'll cross that bridge when we come to it.

關於 BD 資本配置的未來以及利率走向，我認為現在我們 2025 年的純粹重點將是整合，以及真正推動 VTAMA 表現，然後我們將跨越當我們到達那座橋時。

Jason Gerberry, Bank of America.

傑森‧格伯里，美國銀行。

Hey, guys, good morning. Thanks for taking my question. Mine is just wanted to follow up on the derm event accretion dilution profile. And given this is a new therapeutic vertical, just wondering if you can talk through conceptually the incremental selling and marketing costs versus what you're able to absorb with your own in-house resources?

嘿，夥計們，早安。感謝您提出我的問題。我的只是想跟進皮膚事件增生稀釋情況。鑑於這是一個新的治療垂直領域，只是想知道您是否可以從概念上討論增量銷售和營銷成本與您能夠用自己的內部資源吸收的成本？

I think Dermavant talked at one point about more than $300 million or so OpEx versus your $180 million number. So just kind of wondering, are you putting less behind the product? Or are there cost offsets in your infrastructure or alternatively, the AD costs maybe not fully baked into the $180 million? Just wanted to get some clarity around those inputs.

我認為 Dermavant 有一次談到了超過 3 億美元左右的營運支出，而你們的數字為 1.8 億美元。所以只是想知道，您對產品的投入是否減少了？或者您的基礎設施是否存在成本抵消，或者 AD 成本可能沒有完全計入 1.8 億美元？只是想澄清這些輸入。

And then on your Nexplanon citizens petition filed, is there any backstory to that? What I'm getting at is I don't know if the FDA -- were they unreceptive to proposed changes and product-specific guidance? Or is this basically your first sort of attempt to get the FDA to pay increased attention to the applicator similarity points that were raised in the CP? Thanks.

那麼在您提交的 Nexplanon 公民請願書中，有什麼背景故事嗎？我的意思是，我不知道 FDA 是否不接受擬議的變更和特定於產品的指導？或者這基本上是您第一次嘗試讓 FDA 更專注於 CP 中提出的塗藥器相似點？謝謝。

So I'll take the VTAMA question of first, Jason. So from an OpEx perspective, I'm not exactly sure what Dermavant's disclosure has been, and I think that's approximate $300 million in numbers, it's a very round number. We think we're onboarding operating costs of about $240 million.

首先，我將回答 VTAMA 問題，Jason。因此，從營運支出的角度來看，我不太確定 Dermavant 所揭露的內容是什麼，我認為這個數字大約是 3 億美元，這是一個非常整數的數字。我們認為我們的營運成本約為 2.4 億美元。

And in terms of how that cost is broken out, roughly a third of that is sales and marketing costs for which we intend to onboard that lock, stock, and barrel. That's the expertise in the US derm sales and marketing capabilities. That is a key value driver for us going forward and its expertise were absolutely focused on onboarding in the right way.

就成本的分解方式而言，其中約三分之一是銷售和行銷成本，我們打算將其納入鎖、庫存和桶中。這就是美國derm的專業銷售和行銷能力。這是我們前進的關鍵價值驅動力，其專業知識絕對專注於以正確的方式入職。

And so, the synergies that we've achieved and we'll come from the remainder. And I think a significant part of the difference in the cost you might be looking at versus the $180 million of OpEx we're talking about next year is R&D costs under prior ownership that were already coming off.

因此，我們已經實現的協同效應將來自其餘部分。我認為，您可能看到的成本與我們明年討論的 1.8 億美元營運支出之間的很大一部分差異是先前所有權下已經減少的研發成本。

So I think that's a pretty important distinction between prior benchmarks and the OpEx that we believe we're onboarding for 2025. And just to reiterate from the prepared comments, we just see one year of dilution from onboarding the product. It will be accretive in 2026 and thereafter at what we believe are very achievable revenue estimates.

因此，我認為這是先前的基準與我們認為 2025 年即將推出的營運支出之間的一個非常重要的區別。重申一下準備好的評論，我們只看到產品使用後一年的稀釋。到 2026 年及此後，該收入將不斷增加，我們認為收入預測是非常容易實現的。

Jason, in regards to the question on submission of the petition, it's still pending. So I can't speak to that in terms of when we get a response from the FDA. But the issue that I wanted to clarify is the fact that we do have patent protection on our applicator device until 2030.

Jason，關於提交請願書的問題，目前仍然懸而未決。因此，我無法就我們何時收到 FDA 的答覆來談論這一點。但我想澄清的問題是，我們的塗抹器設備在 2030 年之前確實享有專利保護。

And I think that that needs to be essentially understood that unless you want to devise and design and submit in your own clinical studies, a new completely new applicator, you can't use our applicator and past until 2030. And so, that is one aspect when you make mention of the applicator device in terms of the patent protection.

我認為這需要從本質上理解，除非您想在自己的臨床研究中設計和提交一種全新的施藥器，否則直到 2030 年您才能使用我們的施藥器。因此，當您在專利保護方面提到塗​​抹器設備時，這是一方面。

But also, the fact of the matter is I've always signaled the fact that it's not an easy go of it. And again, like I said, if you just want to use a proxy, just look at the IUD Mirena in terms of the fact that we're now like seven years post LOE and there's still no true generics in the market.

但事實上，我一直都表示這並不是一件容易的事。再說一次，就像我說的，如果你只是想使用替代品，只需看看子宮內避孕器曼月樂，因為我們現在距離 LOE 已經過去七年了，而且市場上仍然沒有真正的仿製藥。

It's not an easy thing to do. And you've got to have a huge amount of infrastructure investments in terms of not only sales force to train your physicians on how to insert and remove your rod, but also all of the other things that goes into medical affairs and pharmacovigilance, all the nature of that. The FDA is very sensitive to that.

這不是一件容易的事。你必須有大量的基礎設施投資，不僅是銷售人員來培訓你的醫生如何插入和取出你的桿，而且還有涉及醫療事務和藥物警戒的所有其他事情，所有這些那的性質。FDA 對此非常敏感。

So I think that's my view in terms of the runway ahead for Nexplanon.

所以我認為這就是我對 Nexplanon 未來發展的看法。

Got it. Thanks so much, guys.

知道了。非常感謝，夥計們。

Umer Raffat, Evercore ISI.

烏默·拉法特，Evercore ISI。

Hi, guys. Thanks for taking my question. I'm curious, the $180 million in OpEx you referred to, is that inclusive of the ex-US spend you intend to do as well? And in a scenario where the VTAMA underperformed, how much can you pull that back? Thank you.

嗨，大家好。感謝您提出我的問題。我很好奇，您提到的 1.8 億美元營運支出是否也包括您打算用於的美國以外的支出？在 VTAMA 表現不佳的情況下，您能將其拉回多少？謝謝。

So I'll take the first part of that question. So in the $180 million in OpEx for 2025, that's really US-focused. There's really nothing of significance ex-US in that.

所以我將回答這個問題的第一部分。因此，在 2025 年 1.8 億美元的營運支出中，這確實以美國為中心。除了美國之外，這確實沒有什麼重要意義。

And for the second part of your question in terms of how much can we pull it back, look, you can always cut back on promotional spend. We have plans in place to synergize on the G&A pieces of the cost structure, but I don't know that we would be focused on that in 2025.

對於你問題的第二部分，即我們可以將其削減多少，你看，你總是可以削減促銷支出。我們已製定計劃對成本結構的一般管理費用部分進行協同增效，但我不知道我們是否會在 2025 年重點關注這一點。

We will be putting all of our energies behind the successful launch of VTAMA. So the next 14 months, let's say at the end of 2025, are really key. And so, if we have to think about retrenchment, Umer, we will be looking at that beyond 2025.

我們將全力以赴支持 VTAMA 的成功推出。因此，接下來的 14 個月，比如說 2025 年底，非常關鍵。因此，如果我們必須考慮裁員，Umer，我們將在 2025 年之後考慮。

Great.

偉大的。

That concludes our Q&A session. I will now turn the call back over to Kevin Ali for closing remarks.

我們的問答環節到此結束。現在，我將把電話轉回給凱文·阿里，讓其致閉幕詞。

Thank you. Just in closing, look, in 2024, our commercial execution, I believe, has been very strong. Our largest product, Nexplanon, is well-positioned as I mentioned earlier, to deliver $1 billion of revenue next year. And we've added other notable growth drivers with Emgality and most recently, what we've just discussed this morning, VTAMA.

謝謝。最後，我相信，到 2024 年，我們的商業執行力非常強勁。正如我之前提到的，我們最大的產品 Nexplanon 處於有利地位，明年將帶來 10 億美元的收入。我們還透過 Emgality 增加了其他顯著的成長驅動因素，以及最近我們今天早上剛討論的 VTAMA。

Further, we've been extremely disciplined on operating costs and driving adjusted EBITDA growth in support of achieving a $1 billion of free cash flow before one-time costs for the full year 2024. So we're well on track to delivering a very solid year and we want to thank you for dialing in today and we'll talk to you soon.

此外，我們對營運成本非常嚴格，並推動調整後 EBITDA 成長，以支持在 2024 年全年實現 10 億美元的一次性成本前自由現金流。因此，我們即將迎來非常堅實的一年，我們要感謝您今天撥打電話，我們很快就會與您聯繫。

This concludes today's call. You may now disconnect.

今天的電話會議到此結束。您現在可以斷開連線。