Organon & Co (OGN) 2022 Q4 法說會逐字稿

Ladies and gentlemen, thank you for standing by. At this time, I would like to welcome everyone to the Organon Fourth Quarter and Full Year 2022 Earnings Conference Call. (Operator Instructions) As a reminder, this call is being recorded. I would now like to turn the call over to Jennifer Halchak, Vice President, Investor Relations. Please begin your conference.

女士們，先生們，謝謝你們的支持。此時，我想歡迎大家參加 Organon 第四季度和 2022 年全年收益電話會議。 （操作員說明）提醒一下，此通話正在錄音中。我現在想把電話轉給投資者關係副總裁 Jennifer Halchak。請開始您的會議。

Thank you, Dennis. Good morning, everyone. Thank you for joining Organon's Fourth Quarter and Full Year 2022 Earnings Call. With me today are Kevin Ali, Organon's Chief Executive Officer, who will cover strategy and operational highlights; and Matt Walsh, our Chief Financial Officer, who will review performance, guidance and capital allocation. Dr. Sandra Milligan Organon's Head of R&D, will also be joining us for the Q&A portion of this call.

謝謝你，丹尼斯。大家，早安。感謝您參加 Organon 的第四季度和 2022 年全年收益電話會議。今天和我一起的是 Organon 的首席執行官 Kevin Ali，他將介紹戰略和運營亮點；我們的首席財務官馬特·沃爾什 (Matt Walsh) 將審查業績、指導和資本分配。 Sandra Milligan Organon 博士的研發主管也將加入我們的電話問答環節。

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.

今天，我們將引用一個演示文稿，在本次電話會議期間，您可以在我們的網絡廣播中看到該演示文稿。此演示文稿也將在我們的 Organon 投資者關係網站 www.organon.com 的“活動和演示文稿”部分的電話會議之後提供。

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，管理層在本次電話會議期間討論的某些信息將包含前瞻性陳述。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存在重大差異，這些風險和不確定性在公司提交給美國證券交易委員會的文件中進行了討論，包括我們的 10-K 和隨後的定期文件。

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 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 財務措施，這些措施應被視為對根據 GAAP 編制的財務措施的補充而非替代。這些非 GAAP 措施與可比較的 GAAP 措施的對賬包含在新聞稿和電話會議演示中。

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

我現在想把電話轉給我們的首席執行官凱文阿里。

Good morning, everyone, and thank you, Jen. Welcome to today's call where we'll talk about our fourth quarter and full year 2022 results. To begin with, I'm exceptionally proud of Organon's performance in our first full year as a stand-alone company. For the full year 2022, we delivered a 4% increase in total company revenue at constant currency. We also demonstrated strong profitability, generating an adjusted EBITDA of $2.1 billion, representing a 33.8% margin. We delivered strong growth in our Women's Health and Biosimilars portfolios as well as we grew our Established Brands business.

大家早上好，謝謝你，珍。歡迎來到今天的電話會議，我們將討論我們的第四季度和 2022 年全年業績。首先，我對 Organon 作為一家獨立公司在第一年的表現感到非常自豪。對於 2022 年全年，我們以固定匯率計算的公司總收入增長了 4%。我們還展示了強勁的盈利能力，調整後的 EBITDA 為 21 億美元，利潤率為 33.8%。我們的女性健康和生物仿製藥產品組合實現了強勁增長，同時我們也發展了知名品牌業務。

Starting with Women's Health. For the full year 2022, the Women's Health franchise delivered 7% growth on a constant currency basis. This includes $834 million of revenue from Nexplanon, which grew 11% in 2022 at constant currency. This marks Nexplanon's second consecutive year of double-digit growth. That is a significant achievement for a product that has been around for over a decade and relies on continually attracting new patients to the product. We are seeing particular strength outside the U.S. where Nexplanon grew 17% in 2022, especially in our LAMERA region, where improved access is helping to drive demand. In the U.S., Nexplanon grew 8% in 2022 and continues to gain share in the lark of a long-acting reversible contraceptive market. In 2022, we also trained more than 20,000 health care providers to insert Nexplanon, and we will continue to train more providers in 2023.

從女性健康開始。在 2022 年全年，女性健康特許經營權按固定匯率計算實現了 7% 的增長。這包括來自 Nexplanon 的 8.34 億美元收入，按固定匯率計算，該收入在 2022 年增長了 11%。這標誌著 Nexplanon 連續第二年實現兩位數增長。對於已經存在了十多年並且依賴於不斷吸引新患者使用該產品的產品來說，這是一項重大成就。我們看到美國以外的市場表現尤為強勁，Nexplanon 在 2022 年增長了 17%，尤其是在我們的 LAMERA 地區，該地區改善的准入有助於推動需求。在美國，Nexplanon 在 2022 年增長了 8%，並繼續在長效可逆避孕藥市場的百靈鳥中佔據份額。 2022 年，我們還培訓了 20,000 多名醫療保健提供者以插入 Nexplanon，我們將在 2023 年繼續培訓更多提供者。

Importantly, we continue to hone our go-to-market strategy emphasizing follow-on reviews with health care providers, actively prescribing Nexplanon for whom additional training may strengthen their comfort in prescribing Nexplanon.

重要的是，我們繼續完善我們的上市戰略，強調與醫療保健提供者的後續審查，積極開出 Nexplanon 處方，額外的培訓可能會加強他們開 Nexplanon 處方的舒適度。

We continue to monitor the impact of the overturn of Roe v. Wade on the contraception market. Since July 2022, we have seen demand growth for Nexplanon in the most restricted states as well as protected and semi-restricted states. This speaks to the need now more than ever for highly efficacious form of contraception.

我們將繼續關注推翻 Roe v. Wade 案對避孕市場的影響。自 2022 年 7 月以來，我們看到 Nexplanon 在最受限制的州以及受保護和半限制的州的需求增長。這說明現在比以往任何時候都更需要高效的避孕方式。

In real-world views, Nexplanon is over 99% effective in preventing pregnancies compared with some forms of short-acting contraceptives where efficacy is less than 80%. That is in part because when women use a long-acting contraceptive like Nexplanon, it takes the patient-dependent aspect out of it. Nexplanon is inserted within minutes and currently provides efficacious -- continuous efficacy for up to 3 years. We also believe we will be successful in demonstrating the 5-year efficacy through our ongoing study. But importantly, it wasn't just Nexplanon that continued the growth in Women's Health in 2022. We continue to see good contribution from the Fertility portfolio which in 2022 grew approximately 9% at constant currency despite the impact of COVID in China, which limits patients' ability to begin or continue treatment at fertility clinics.

在現實世界中，Nexplanon 在預防懷孕方面的有效性超過 99%，而某些形式的短效避孕藥的有效性低於 80%。這在一定程度上是因為當女性使用像 Nexplanon 這樣的長效避孕藥時，它消除了患者依賴性的問題。 Nexplanon 可在數分鐘內插入，目前可提供長達 3 年的有效持續療效。我們還相信，我們將通過正在進行的研究成功展示 5 年的療效。但重要的是，不僅僅是 Nexplanon 在 2022 年繼續推動女性健康業務的增長。我們繼續看到生育產品組合的良好貢獻，儘管 COVID 在中國的影響限制了患者，但按固定匯率計算，該產品組合在 2022 年增長了約 9% ' 在生育診所開始或繼續治療的能力。

The U.S. and China are large fertility markets and together represent more than half of our current fertility business. China, is a particularly important fertility market for us, with the potential to grow to more than 1 million IVF cycles a year over the next decade. The number of cycles in the China is already 3x the number of cycles in the U.S. And as we have discussed many times before, fertility is a therapy area with strong demographic tailwinds. Women are waiting longer to start their families, resulting in higher prevalence of infertility and more governments are realizing that they need to take action to address the associated low birth rates.

美國和中國是巨大的生育市場，合計占我們目前生育業務的一半以上。中國對我們來說是一個特別重要的生育市場，在未來十年內有可能增長到每年超過 100 萬個 IVF 週期。中國的周期數已經是美國周期數的 3 倍。正如我們之前多次討論的那樣，生育是一個具有強大人口順風的治療領域。婦女等待組建家庭的時間更長，導致不孕症患病率更高，越來越多的政府意識到他們需要採取行動解決相關的低出生率問題。

More than 100 countries around the world have a fertility rate or the number of births per woman that is significantly below the replacement rate that is required to sustain a population and its GDP growth. Countries are offering more monetary incentives for households to expand their families and many are offering better fertility access and benefits. Organon is one of the few companies with the portfolio helped serve this growing market. The Women's Health franchise is also benefiting from our business development activities. As we think about business development, we are striving for balance between commercialized assets and earlier-stage assets that could become significant growth catalysts for Organon in the longer term.

世界上有 100 多個國家/地區的生育率或每位婦女的生育數大大低於維持人口及其 GDP 增長所需的更替率。各國正在為家庭擴大家庭提供更多的貨幣激勵，許多國家正在提供更好的生育機會和福利。 Organon 是少數幾家擁有產品組合的公司之一，幫助服務於這個不斷增長的市場。女性健康特許經營權也受益於我們的業務發展活動。在我們考慮業務發展時，我們正在努力在商業化資產和早期資產之間取得平衡，從長遠來看，這些資產可能成為 Organon 的重要增長催化劑。

Since spin, through business development, we have added 3 assets to our Women's Health portfolio that are already contributing or will soon be contributing to revenue growth. You will recall that last year, we reacquired the rights to Marvelon and Mercilon, which are combined over contraceptives in selected territories in Asia, including China and Vietnam. Together, Marvelon and Mercilon grew 20% in 2022. The success from the repatriation of these assets is just another example of how Organon is applying its own methodologies to maximize the performance of assets that may have been under prioritized in other companies in the past. We are also very excited about the JADA System, which we added to our portfolio in 2021 with the acquisition of Alydia Health. JADA is a device indicated to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage. And postpartum hemorrhage is one of the most common complications of birth requiring pharmacologic treatment in up to 10% of mothers. At last week's annual meeting for the Society for Maternal-Fetal Medicine, researchers unveiled the results of the Roe v. Wade study, which examined JADA'S efficacy and safety in real-world use. In the Roe v. Wade study, researchers analyze a large population of 800 women who were treated with the device from October 2020 to April 2022 at 16 hospitals across the United States. Researchers concluded that JADA worked quickly and was highly effective in controlling postpartum hemorrhage after both vaginal and cesarean births. Researchers also found that the device successfully treated postpartum hemorrhage in 92.5% of vaginal births and 83.7% of cesarean births.

自分拆以來，通過業務發展，我們已將 3 項資產添加到我們的女性健康產品組合中，這些資產已經或即將為收入增長做出貢獻。你會記得去年，我們重新獲得了 Marvelon 和 Mercilon 的權利，它們在亞洲選定地區（包括中國和越南）的避孕藥具上合併。 Marvelon 和 Mercilon 一起在 2022 年增長了 20%。這些資產遣返的成功只是 Organon 如何應用自己的方法來最大化過去其他公司可能未優先考慮的資產績效的另一個例子。我們也對 JADA 系統感到非常興奮，我們在 2021 年通過收購 Alydia Health 將其添加到我們的產品組合中。 JADA 是一種用於控制和治療產後異常子宮出血或出血的裝置。產後出血是最常見的分娩並發症之一，多達 10% 的母親需要藥物治療。在上週的母胎醫學協會年會上，研究人員公佈了 Roe v. Wade 研究的結果，該研究檢查了 JADA 在實際使用中的有效性和安全性。在 Roe v. Wade 研究中，研究人員分析了 2020 年 10 月至 2022 年 4 月期間在美國 16 家醫院接受該設備治療的 800 名女性。研究人員得出結論，JADA 起效迅速，在控制順產和剖宮產後的產後出血方面非常有效。研究人員還發現，該設備成功治療了 92.5% 的順產和 83.7% 的剖宮產產後出血。

In addition, the device was safe and only had to remain in place for a few hours after placement, allowing for a more efficient postpartum care experience. Our goals in acquiring Jada included the opportunity to speed up access to this innovation in the U.S. and to leverage our global capability to bring this product to markets around the world. We continue to add accounts and are now at about 1,000 hospitals in the U.S. with more than 15,000 mothers having been treated with JADA. Additionally, in 2022, we made our first ex-U.S. shipments and has also committed to the EU for approval. We're also pursuing earlier-stage assets that address the areas of highest unmet medical needs and have the potential to expand our portfolio in Women's Health.

此外，該設備是安全的，放置後只需在原位保留幾個小時，從而提供更有效的產後護理體驗。我們收購 Jada 的目標包括有機會加快在美國獲得這種創新，並利用我們的全球能力將這種產品推向世界各地的市場。我們繼續增加客戶，現在美國約有 1,000 家醫院有超過 15,000 名母親接受了 JADA 治療。此外，在 2022 年，我們製作了第一個美國以外的產品。出貨量，並已承諾向歐盟申請批准。我們還在尋求早期資產，以解決最未滿足的醫療需求領域，並有可能擴大我們在女性健康領域的投資組合。

Since spin, we've added 4 earlier-stage assets in the Women's Health portfolio at different stages of development. The farthest along is OG-6219, a unique new mechanism of action, which is a candidate to treat endometriosis locally instead of systemically. In October 2022, we enrolled the first patient in our Phase II ELENA study, which is expected to be completed by the end of 2024.

自旋轉以來，我們在處於不同發展階段的女性健康產品組合中添加了 4 個早期資產。走得最遠的是 OG-6219，這是一種獨特的新作用機制，是局部而非全身治療子宮內膜異位症的候選藥物。 2022 年 10 月，我們在 II 期 ELENA 研究中招募了第一位患者，該研究預計將於 2024 年底完成。

Turning to Biosimilars. Our Biosimilars franchise grew 17% on a constant currency basis in 2022, marking its second consecutive year of double-digit growth. Biosimilars are an important growth driver for the company. And in 2022, we underscored our commitment to the business by adding a second R&D partner with Shanghai Henlius. All 5 of our biosimilars contributed to the strong performance in 2022. Renflexis, our largest selling biosimilar, grew 22% last year, driven by solid performance in the U.S. and Canada, despite already being on the market for 5-plus years. Ontruzant, our second largest biosimilar grew more than 40% in the U.S. but that growth was offset by competitive pressures in Europe. Hadlima, our biosimilar for Humira, had a very strong performance in 2022, reflecting its successful 2021 launch in Canada and Australia. We expect that our success in those markets will help with provider confidence when we launched Hadlima in the U.S. in July of this year. Because Humira is the largest biologic to face biosimilar competition in the U.S., we are frequently asked about the competitive position with Hadlima.

轉向生物仿製藥。到 2022 年，我們的生物仿製藥特許經營權按固定匯率計算增長了 17%，這是連續第二年實現兩位數增長。生物仿製藥是公司重要的增長動力。 2022 年，我們與上海復宏漢霖增加了第二個研發合作夥伴，強調了我們對業務的承諾。我們所有 5 種生物仿製藥都為 2022 年的強勁表現做出了貢獻。Renflexis 是我們銷量最大的生物仿製藥，儘管已經上市 5 年多，但在美國和加拿大的穩健表現的推動下，去年增長了 22%。我們的第二大生物仿製藥 Ontruzant 在美國的增長超過 40%，但這一增長被歐洲的競爭壓力所抵消。我們的 Humira 生物仿製藥 Hadlima 在 2022 年表現非常強勁，反映了其 2021 年在加拿大和澳大利亞的成功上市。當我們今年 7 月在美國推出 Hadlima 時，我們預計我們在這些市場的成功將有助於增強供應商的信心。由於 Humira 是美國面臨生物仿製藥競爭的最大生物製劑，我們經常被問及與 Hadlima 的競爭地位。

To reiterate our messaging, we believe that the best physician biosimilars will be those that share the same attributes as the originator. That includes the option for high concentration citrate pre-formulation as well as a low concentration formulation, and we expect to have both at launch. We also believe that real-world evidence and experience in other markets will be something that providers will appreciate. We have that data through our collaborator, Samsung Bioepis from their experience with Hadlima and EU as well as from our own successful launches in Canada and Australia.

重申我們的信息，我們相信最好的醫生生物仿製藥將是那些與原研藥具有相同屬性的生物仿製藥。這包括高濃度檸檬酸鹽預製劑和低濃度製劑的選擇，我們希望在發佈時同時擁有這兩種製劑。我們還相信，其他市場的真實證據和經驗將受到供應商的讚賞。我們通過我們的合作者 Samsung Bioepis 從他們在 Hadlima 和歐盟的經驗以及我們自己在加拿大和澳大利亞的成功發布中獲得了這些數據。

And finally, we believe our pen design can be a differentiator for patients. Samsung, is an expert in device design and manufacturing and has designed the pen with the aim of providing a frictionless experience for new patients and those transitioning from Humira. That said, with multiple parties launching midyear, we have also conveyed our belief that 2023 will be a modest ramp-up year with the market for biosimilars really forming in 2024 and 2025 and beyond.

最後，我們相信我們的筆設計可以讓患者與眾不同。三星是設備設計和製造方面的專家，設計這款筆的目的是為新患者和從 Humira 過渡的患者提供無摩擦的體驗。也就是說，隨著多方在年中啟動，我們也表達了我們的信念，即 2023 年將是適度增長的一年，生物仿製藥市場將在 2024 年和 2025 年及以後真正形成。

Finally, let's talk about Established Brands, which currently represents about 2/3 of our overall business and generate significant free cash flow. The portfolio continues to demonstrate the sustainability and untapped potential of these brands. Over the longer term, given the maturity of the portfolio, we expect close to flat performance for our Established Brands business. In 2022, we benefited from some onetime events as well as from delayed VBP implementation that helped the franchise deliver growth of 3% at constant currency for the full year.

最後，讓我們談談 Established Brands，它目前約占我們整體業務的 2/3，並產生可觀的自由現金流。該組合繼續展示這些品牌的可持續性和未開發的潛力。從長遠來看，鑑於投資組合的成熟度，我們預計我們的知名品牌業務的業績將接近持平。 2022 年，我們受益於一些一次性事件以及延遲的 VBP 實施，這幫助特許經營權實現全年 3% 的固定匯率增長。

In the near term, as we think about 2023, we believe we will be able to offset the expected impact from Round 7 of VBP with continued focus on maximizing the potential of these well-known brands through continuous demand generation, and we expect the Established Brands to achieve generally flat performance in 2023 on a constant currency basis.

在短期內，考慮到 2023 年，我們相信我們將能夠抵消第 7 輪 VBP 的預期影響，繼續專注於通過不斷產生需求來最大限度地發揮這些知名品牌的潛力，我們預計已建立的按固定匯率計算，品牌在 2023 年的業績基本持平。

Briefly turning to geographic performance. There are 2 important takeaways here: one, geographic risk in our revenue is well distributed; and two, each of these geographic regions grew in 2022. That includes China, which faced significant challenges related to COVID in 2022. As we think about 2023, we believe that strength in the retail channel, growth in fertility as well as the benefits from the reacquisition of Marvelon and Mercilon will together offset the expected VBP impact to our China business in 2023. We are extremely proud of our 2022 achievements, and I want to thank our 10,000 founders worldwide for rising together for living our purpose and for delivering the success Organon had in our first full year as a stand-alone company. I'd like to now turn the call over to Matt. Thank you.

簡要地轉向地理性能。這裡有兩個重要的要點：第一，我們收入中的地理風險得到了很好的分配；第二，這些地理區域中的每一個都在 2022 年實現了增長。其中包括中國，它在 2022 年面臨與 COVID 相關的重大挑戰。在我們考慮 2023 年時，我們認為零售渠道的實力、生育率的增長以及來自重新收購 Marvelon 和 Mercilon 將共同抵消 VBP 對我們 2023 年中國業務的預期影響。我們為我們 2022 年的成就感到非常自豪，我要感謝我們全球 10,000 名創始人為了實現我們的目標而共同崛起並取得成功Organon 作為獨立公司度過了我們的第一個完整年度。我現在想把電話轉給馬特。謝謝。

Thanks, Kevin. Before I talk in more depth about our results, I'll remind you that we haven't completely lapped the June 2021 spin transaction as far as financial reporting is concerned. So while our 2022 third and fourth quarters are apples-to-apples with the prior year periods, first half of 2022 comparability is impacted by the carve-out basis of accounting that we needed to employ for pre-spin-off accounting periods. And that really implies more to expense items on the full year income statement rather than revenue, and I'll call that out as necessary.

謝謝，凱文。在我更深入地談論我們的結果之前，我會提醒您，就財務報告而言，我們還沒有完全完成 2021 年 6 月的分拆交易。因此，雖然我們的 2022 年第三和第四季度與上年同期相差無幾，但 2022 年上半年的可比性受到我們需要在分拆前會計期間採用的分拆會計基礎的影響。這確實意味著全年損益表中的費用項目比收入更多，我會在必要時指出這一點。

So with that opener, we'll move to Slide 7 and discuss fourth quarter revenue. Fourth quarter revenue was approximately $1.5 billion, down 7% as reported, but up 1% at constant currency. And this marks our fourth consecutive quarter of constant currency growth. We'll spend more time talking about the individual drivers when we get to the full year. But isolating the fourth quarter for the moment, we had solid volume growth in the period. Our key growth franchises, Women's Health and Biosimilars were the main drivers of growth, but Established Brands also contributed. For example, recently, we've seen particular strength in Atozet in France and Spain. And with some generics still out of the market in Japan, we're getting some pick up there as well.

因此，有了這個開場白，我們將轉到幻燈片 7 並討論第四季度的收入。第四季度收入約為 15 億美元，據報告下降 7%，但按固定匯率計算增長 1%。這標誌著我們連續第四個季度貨幣持續增長。到全年時，我們將花更多時間討論個別車手。但暫時孤立第四季度，我們在此期間實現了穩健的銷量增長。我們的主要增長特許經營權、女性健康和生物仿製藥是增長的主要驅動力，但知名品牌也做出了貢獻。例如，最近，我們在法國和西班牙看到了 Atozet 的特別優勢。由於一些仿製藥仍未進入日本市場，我們也在那裡得到了一些提貨。

In the fourth quarter, we had about a $15 million impact from Volume Based Procurement or VBP in China, which reflects the implementation of Round 7 in November. The Organon product that's impacted in this round is Ezetrol, which is sold as Zetia in markets outside of China. The biggest number on this walk across is foreign exchange translation, which represented an 800 basis point headwind to revenue growth in the fourth quarter. This is the largest FX translation reporting impact of any quarter in 2022. This might seem counterintuitive because everyone's most recent memories of the U.S. dollar weakening versus most foreign currencies. But the numbers show that trend started at the very end of 2022. And given that north of 75% of our revenue is outside the U.S., FX translation was a significant theme for Organon in 2022. Our portfolio faced a significant financial reporting headwind from the strengthening U.S. dollar. And unfortunately, that dynamic masked the operational growth in local currencies that we delivered in the fourth quarter and in the full year.

在第四季度，我們在中國的批量採購或 VBP 產生了大約 1500 萬美元的影響，這反映了 11 月第 7 輪的實施。本輪受影響的 Organon 產品是 Ezetrol，它在中國以外的市場上以 Zetia 的名義銷售。最大的數字是外匯換算，這對第四季度的收入增長造成了 800 個基點的逆風。這是 2022 年任何一個季度中最大的外匯換算報告影響。這似乎有悖常理，因為每個人最近的記憶都是美元兌大多數外幣走弱。但數據顯示，這一趨勢從 2022 年底開始。鑑於我們 75% 的收入來自美國以外，外匯翻譯是 Organon 2022 年的一個重要主題。我們的投資組合面臨來自美元走強。不幸的是，這種動態掩蓋了我們在第四季度和全年交付的以當地貨幣計算的業務增長。

And speaking of a full year, we have an identical revenue bridge on Slide 8. For the full year 2022, revenue was approximately $6.2 billion, down 2% as reported but up 4% at constant currency when compared to prior year. Starting with loss of exclusivity or LOE, for the full year 2022, LOE impact was modest at about $30 million, and it's coming mainly from NuvaRing LOE in the United States. We didn't have any LOE impact in Established Brands this year. And as we've said before, the most significant LOEs facing the Established Brands portfolio washed out prior to the spin-off. And what we expect going forward is a cumulative few hundred million dollars of impact over the next several years.

說到全年，我們在幻燈片 8 上有一個相同的收入橋樑。2022 年全年收入約為 62 億美元，與去年相比下降 2%，但按固定匯率計算增長 4%。從失去獨占權或 LOE 開始，到 2022 年全年，LOE 的影響不大，約為 3000 萬美元，主要來自美國的 NuvaRing LOE。今年我們對 Established Brands 沒有任何 LOE 影響。正如我們之前所說，在分拆之前，面臨 Established Brands 投資組合的最重要的 LOE 被淘汰了。我們預計未來幾年將產生累計數億美元的影響。

The full year impact from VBP of about $20 million primarily reflects the November implementation of Round 7, as I just discussed. We saw an approximate $140 million impact coming from price for the full year 2022. And that's consistent with our expectation that we'll continue to see low single-digit price erosion on a company-wide basis. The majority of pricing pressure continues to come from Established Brands where products are subject to mandatory annual price reductions in some markets as well as from Biosimilars.

正如我剛才所討論的，VBP 的全年影響約為 2000 萬美元，主要反映了第 7 輪 11 月的實施情況。我們看到 2022 年全年價格將產生大約 1.4 億美元的影響。這與我們的預期一致，即我們將繼續看到全公司範圍內的低個位數價格下跌。大部分定價壓力仍然來自知名品牌，在這些品牌中，產品在某些市場以及生物仿製藥中必須每年強制降價。

For volume, we expected to see strong volume growth during 2022 across our franchises, and that indeed happened. We saw volume increases coming from what we call our growth pillars, Nexplanon, Fertility and Biosimilars, but Established Brands also grew volume as well. For example, Nasonex and Singulair drove strength year-on-year, Atozet grew in Europe. And we continue to see significant growth in the China retail channel. When looking at Supply Other, the approximate $70 million impact primarily represents supply sales to Merck and other third parties which consists of relatively low-margin sales of pharmaceutical products under contract manufacturing arrangements.

對於銷量，我們預計 2022 年我們的特許經營權將實現強勁的銷量增長，而這確實發生了。我們看到銷量增長來自我們所謂的增長支柱 Nexplanon、Fertility 和 Biosimilars，但 Established Brands 的銷量也有所增長。例如，Nasonex 和 Singulair 同比增長，Atozet 在歐洲增長。我們繼續看到中國零售渠道的顯著增長。在查看供應其他方面時，大約 7000 萬美元的影響主要代表向默克和其他第三方的供應銷售，其中包括根據合同製造安排銷售利潤相對較低的醫藥產品。

Last year, we signaled that the volumes under these arrangements would decline in 2022, which has been the case. And finally, you can see the significant financial reporting headwind we had in foreign exchange translation. 600 basis points for the full year, which again is a function of more than 75% of our revenue being generated outside the U.S.

去年，我們表示這些安排下的交易量將在 2022 年下降，事實確實如此。最後，您可以看到我們在外匯轉換方面遇到的重大財務報告逆風。全年 600 個基點，這也是我們 75% 以上的收入來自美國境外的結果。

The next few slides lay out our performance by franchise. Kevin covered very well the highlights, and the quarterly and full year details are provided in the supporting earnings materials. So I'll focus on topics that may be relevant to your modeling as we think about 2023. We'll start with Women's Health on Slide 9.

接下來的幾張幻燈片按特許經營列出了我們的表現。凱文很好地介紹了亮點，季度和全年的詳細信息在支持收益材料中提供。因此，在我們考慮 2023 年時，我將重點關注可能與您的建模相關的主題。我們將從幻燈片 9 上的女性健康開始。

As Kevin mentioned, Nexplanon had a strong performance in 2022, was up 8% ex FX in the quarter and 11% for the full year. In fact, we set 2 new sales records for Nexplanon in 2022. First in the third quarter and then again in the fourth quarter. As you think about quarterly phasing for next year, it's worth reminding you that in the fourth quarter of last year, next month also set a sales record which was then sequentially followed by a weaker first quarter due in part to the buy-in, buyout dynamic we tend to see around the timing of price increases in the U.S. This is a dynamic we would expect to see again in the first quarter of 2023.

正如凱文提到的那樣，Nexplanon 在 2022 年表現強勁，本季度不計匯率增長 8%，全年增長 11%。事實上，我們在 2022 年為 Nexplanon 創造了兩項新的銷售記錄。首先是在第三季度，然後是在第四季度。當你考慮明年的季度階段時，值得提醒你的是，在去年第四季度，下個月也創下了銷售記錄，緊接著是第一季度的疲軟，部分原因是買入、買斷我們傾向於在美國價格上漲的時間前後看到這種動態。我們希望在 2023 年第一季度再次看到這種動態。

Turning to Biosimilars on Slide 10. As Kevin mentioned, this franchise continues to be an important growth driver for us. We know investors are focused on the potential revenue contribution from our U.S. launch of Hadlima this year. Based on our expectations for a gradual market formation in 2023 and only a partial year revenue contribution given our July 1 launch, we expect that globally, Hadlima will represent no more than about 1.5% of our consolidated 2023 revenue.

轉向幻燈片 10 上的生物仿製藥。正如凱文所提到的，該特許經營權仍然是我們重要的增長動力。我們知道投資者關注我們今年在美國推出的 Hadlima 的潛在收入貢獻。根據我們對 2023 年市場逐漸形成的預期以及我們 7 月 1 日推出後僅貢獻部分年度收入，我們預計在全球範圍內，Hadlima 將占我們 2023 年綜合收入的不超過 1.5% 左右。

Turning to Established Brands now on Slide 11. Here, I want to drill down into the fourth quarter because in addition to VBP implementation, there was another item that impacted Established Brands fourth quarter performance. In January 2023, we initiated market actions for sterile suspension injectables, Diprospan and Celestone Chronodose. This was related to a purchase component used in the sterile filling process at Organon's Heist facility in Belgium that was determined to be nonconforming.

現在轉到幻燈片 11 上的 Established Brands。在這裡，我想深入了解第四季度，因為除了 VBP 實施之外，還有另一個項目影響了 Established Brands 第四季度的業績。 2023 年 1 月，我們針對無菌混懸注射劑 Diprospan 和 Celestone Chronodose 啟動了市場行動。這與比利時 Organon 的 Heist 工廠無菌灌裝過程中使用的採購組件有關，該組件被確定為不合格。

To be clear, no product quality complaints or adverse events have been reported nor are any expected. Due to the compliance aspect, it was prudent to exercise these market actions and discard inventory deemed to be impacted. And for reference, combined, these 2 products represented about $165 million of revenue in 2022.

需要明確的是，沒有產品質量投訴或不良事件的報告，也沒有預期的結果。出於合規方面的考慮，採取這些市場行動並丟棄被視為受影響的庫存是謹慎的做法。作為參考，這兩種產品在 2022 年的收入約為 1.65 億美元。

Turning to Slide 12. You can see that this action had the effect of reducing fourth quarter revenue by $8 million for potential sales returns and we recorded a onetime inventory charge of $36 million that shows up in cost of goods sold. We're breaking out the issue in this manner to show that excluding the total $44 million that flows through to adjusted EBITDA, our fourth quarter adjusted EBITDA margin would have been 28.4%, very much in line with what our expectations were for the fourth quarter when we last provided guidance in November.

轉到幻燈片 12。您可以看到，由於潛在的銷售退貨，此操作導致第四季度收入減少 800 萬美元，我們記錄了 3600 萬美元的一次性庫存費用，這顯示在已售商品的成本中。我們以這種方式解決這個問題，以表明不包括流入調整後 EBITDA 的 4400 萬美元總額，我們第四季度調整後的 EBITDA 利潤率為 28.4%，非常符合我們對第四季度的預期我們上次在 11 月提供指導時。

We're also showing the full year impact of reference.

我們還展示了參考的全年影響。

Since spinoff, we've been very pleased with our ability to forecast our business. So while events like a market action were always a potential risk in this industry, we're confident about the durability and diversity of our business as it relates to forecasting it.

自分拆以來，我們對我們預測業務的能力感到非常滿意。因此，儘管市場行為等事件始終是該行業的潛在風險，但我們對與預測相關的業務的持久性和多樣性充滿信心。

Let's now turn to key P&L line items on Slide 13. For non-GAAP gross profit, we are excluding from cost of goods sold, purchase accounting amortization and onetime items related to the spin-off. The market action I just discussed was the major driver of the change in gross margin in the fourth quarter compared to the prior year period.

現在讓我們轉到幻燈片 13 上的關鍵 P&L 項目。對於非 GAAP 毛利，我們不包括銷售成本、採購會計攤銷和與分拆相關的一次性項目。我剛才討論的市場行為是第四季度毛利率與去年同期相比變化的主要驅動因素。

For the full year, adjusted gross margin was 65.7% compared with 64.7% for the full year 2021. Keep in mind that full year comparisons for items below the revenue line are less meaningful because they're only truly comparable for the second half of the year. That said, the year-over-year increase in adjusted gross margin is primarily a result of lower supply sales in 2022, which carry lower margins as well as pre-spin allocated costs related to the separation of Organon that occurred in the prior year.

全年調整後的毛利率為 65.7%，而 2021 年全年為 64.7%。請記住，收入線以下項目的全年比較意義不大，因為它們僅在下半年才真正具有可比性年。也就是說，調整後毛利率的同比增長主要是由於 2022 年的供應銷售下降（利潤率較低）以及與上一年發生的 Organon 分離相關的分拆前分配成本。

Adjusted EBITDA margin was 25.6% in the fourth quarter compared to 29.3% in the same period of last year. Adjusted EBITDA margin was 33.8% for the full year 2022 compared with 36.1% for the full year 2021. The decline in the fourth quarter and full year was a result of costs associated with the market action at Heist as well as expenses related to positioning the company for future growth. We've been talking about the importance of reinvestment in the business to create a pipeline of new products to drive revenue growth for a while now. And you see that in higher selling and promotional costs as well as research and development spend associated with our prior acquisitions.

第四季度調整後的 EBITDA 利潤率為 25.6%，而去年同期為 29.3%。 2022 年全年調整後的 EBITDA 利潤率為 33.8%，而 2021 年全年為 36.1%。第四季度和全年的下降是由於與 Heist 的市場行為相關的成本以及與定位相關的費用公司未來的發展。一段時間以來，我們一直在談論對業務進行再投資以創建新產品管道以推動收入增長的重要性。你會看到更高的銷售和促銷成本以及與我們之前的收購相關的研發支出。

As we look at debt capitalization and leverage on Slide 14, as of December 31, 2022, we have gross bank debt of $8.9 billion netted against cash and cash equivalents of $706 million. We ended the year with a net leverage ratio of about 3.8x, which ticked up from the 3.6x we reported at the end of the third quarter. That primarily reflects the combination of the strength of the euro and impact of the fourth quarter 2022 results.

當我們查看幻燈片 14 上的債務資本化和槓桿率時，截至 2022 年 12 月 31 日，我們的銀行債務總額為 89 億美元，現金和現金等價物為 7.06 億美元。我們年底的淨槓桿率約為 3.8 倍，比我們在第三季度末報告的 3.6 倍略有上升。這主要反映了歐元的強勢和 2022 年第四季度業績的影響。

Given our adjusted EBITDA guidance for 2023, which I'll discuss in a moment, together with the currency impact on our euro-denominated debt, leverage is likely to be stubborn in 2023. In fact, given the inevitable math of this past quarter's inclusion in our LTM EBITDA calculation during the upcoming quarters, we could see leverage tick higher before leveling back down by the end of the year. This doesn't have a significant impact on our capital allocation priorities, given the strong cash flow characteristics of the business.

考慮到我們調整後的 2023 年 EBITDA 指引（我將在稍後討論），以及貨幣對我們以歐元計價的債務的影響，槓桿率在 2023 年可能會持續存在。事實上，考慮到上個季度納入的不可避免的數學計算在我們未來幾個季度的 LTM EBITDA 計算中，我們可以看到槓桿率在年底前回落之前走高。鑑於該業務的強勁現金流特徵，這不會對我們的資本配置優先級產生重大影響。

So let's turn to Slide 15 for a moment and take a closer look at cash flow. When we reported our third quarter financials, there was still a lot of noise in the September year-to-date cash flow numbers stemming from some transient spin-related items. This is washing out. And you can see that in the fourth quarter, our free cash flow generation was very strong. In the full year 2022, there was about $300 million related to nonrecurring spin-related working capital build early in the year. And if you recall the discussion from last quarter, we said that a good portion of that $300 million was actually expected in late 2021, but instead landed in early 2022.

因此，讓我們暫時轉到幻燈片 15，仔細看看現金流。當我們報告第三季度的財務數據時，9 月至今的現金流量數字中仍然存在很多噪音，這些噪音源於一些短暫的分拆相關項目。這是在洗掉。你可以看到，在第四季度，我們產生的自由現金流非常強勁。在 2022 年全年，年初有約 3 億美元與非經常性分拆相關的營運資本建設相關。如果你還記得上個季度的討論，我們說過這 3 億美元中的很大一部分實際上預計在 2021 年底出現，但卻在 2022 年初出現。

With the spin-related build largely behind us and reaching what we expect to be a more normalized ebb and flow to our working capital position, we saw a significant improvement in Q4 cash generation. The other driver was foreign exchange translation. Consistent with weakening of the U.S. dollar, we had a positive impact of $100 million in the fourth quarter from foreign currency cash balances within our global liquidity management program. And that partially offset the $160 million headwind we had experienced year-to-date September. But the key message here is that putting aside the $300 million of working capital build that should not repeat in 2023, our free cash flow ex onetime costs related to the spinoff is in that north of $1 billion range that we communicated at the time of the spin. Our capital allocation priorities remain consistent with past communications. We will continue to prioritize servicing the current dividend, followed by pursuing organic growth through life cycle management opportunities within our current portfolio of products.

隨著與分拆相關的構建在很大程度上落後於我們，並達到我們預期的更正常化的營運資本狀況潮起潮落，我們看到第四季度現金產生有了顯著改善。另一個司機是外匯翻譯。與美元疲軟一致，我們在第四季度從全球流動性管理計劃中的外幣現金餘額中產生了 1 億美元的積極影響。這部分抵消了年初至今 9 月我們經歷的 1.6 億美元逆風。但這裡的關鍵信息是，撇開不應在 2023 年重複的 3 億美元營運資本建設，我們與分拆相關的不包括一次性成本的自由現金流在我們當時溝通的 10 億美元範圍內。旋轉。我們的資本配置重點與過去的溝通保持一致。我們將繼續優先考慮為當前的紅利提供服務，然後通過我們當前產品組合中的生命週期管理機會尋求有機增長。

Capital expenditures in the range of 3% to 4% of revenue remains a good estimate for forecasting purposes. With that capital going to modernizing and growing our production capacity, standup-related investments like our global ERP implementation and other strategic investments in the business. With these priorities satisfied, we expect to have significant remaining cash flow available as we continue to balance external growth opportunities against our commitment to our BB/Ba2 rating.

佔收入 3% 至 4% 的資本支出對於預測目的仍然是一個很好的估計。隨著這些資金用於現代化和提高我們的生產能力，與站立相關的投資，如我們的全球 ERP 實施和其他業務戰略投資。在滿足這些優先事項後，隨著我們繼續平衡外部增長機會與我們對 BB/Ba2 評級的承諾，我們預計將有大量剩餘現金流可用。

Having a higher leverage ratio at points during 2023 likely raises the bar on business development as it competes for capital. But even without discretionary debt repayment, which we've done twice as a stand-alone company, we can still get deals done and stay within the parameters of our rating much as we have been doing since the spin-off.

在 2023 年的某個時間點擁有更高的槓桿率可能會提高業務發展的門檻，因為它會爭奪資本。但即使沒有酌情償還債務（我們作為一家獨立公司已經做過兩次），我們仍然可以完成交易並保持在我們評級的參數範圍內，就像我們自分拆以來所做的那樣。

Now turning to 2023 guidance on Slide 16, where we highlight the items driving our 2023 revenue guidance range of $6.15 billion to $6.45 billion.

現在轉向幻燈片 16 上的 2023 年指導，我們在其中強調推動我們 2023 年收入指導範圍為 61.5 億美元至 64.5 億美元的項目。

Beginning with LOE, we expect an approximate $50 million to $75 million impact for full year 2023, which reflects the continued impact of generic competition for NuvaRing. This also includes an impact from Atozet, which will go LOE in Japan in 2023 as well as a provision for Dulera, where we expect a generic entrant sometime in late 2023 after not seeing 1 in 2022 and or 2021. We expect impact from VBP to be in the range of $125 million to $175 million in 2023, driven mostly by the inclusion of Ezetrol in this latest round. We expect company -- sorry, we expect approximately $75 million to $125 million of price erosion in 2023.

從 LOE 開始，我們預計 2023 年全年的影響約為 5000 萬至 7500 萬美元，這反映了仿製藥競爭對 NuvaRing 的持續影響。這還包括來自 Atozet 的影響，它將在 2023 年在日本進入 LOE 以及 Dulera 的規定，我們預計在 2022 年和/或 2021 年沒有看到 1 個仿製藥進入者後，我們預計在 2023 年底的某個時候。我們預計 VBP 的影響到到 2023 年將在 1.25 億美元至 1.75 億美元之間，這主要是由於 Ezetrol 被納入最新一輪。我們預計公司——抱歉，我們預計 2023 年的價格將下跌約 7500 萬至 1.25 億美元。

On a total company basis, we've been able to stem pricing pressure a little better than we thought at the start of last year. Over the longer term, we would expect pricing erosion to be in the range of 200 to 300 basis points of headwind, and that is mostly related to mandatory pricing decreases in certain markets and smaller LOE impacts but also due to product mix.

在整個公司的基礎上，我們能夠比去年初想像的更好地遏制定價壓力。從長遠來看，我們預計定價侵蝕將在 200 至 300 個基點的逆風範圍內，這主要與某些市場的強制定價下降和較小的 LOE 影響有關，但也與產品組合有關。

So for example, as Biosimilars becomes a bigger business within Organon that will put more pressure on price.

因此，例如，隨著 Biosimilars 成為 Organon 內更大的業務，這將給價格帶來更大的壓力。

And for volume, we expect growth of approximately $500 million to $600 million for the full year, in line with what we saw in 2022. The majority of the volume increase is expected to come from our multiple growth pillars. Nexplanon, Biosimilars, Fertility, China Retail and to a smaller degree, recent business development activity, including JADA.

對於銷量，我們預計全年增長約 5 億至 6 億美元，與我們在 2022 年看到的情況一致。預計大部分銷量增長將來自我們的多個增長支柱。 Nexplanon、Biosimilars、Fertility、China Retail 以及在較小程度上最近的業務發展活動，包括 JADA。

Given where FX spot rates are trending, we would expect a more modest impact from foreign exchange translation in 2023 compared with 2022. We're estimating an approximate $50 million to $100 million impact from FX for the full year which would represent about a 1 percentage point headwind. That means that our guidance range implies constant currency revenue growth of approximately 3.5% at the midpoint.

鑑於外匯即期匯率的趨勢，我們預計 2023 年外匯換算的影響將比 2022 年更溫和。我們估計全年外匯影響約為 5000 萬至 1 億美元，約佔 1%點逆風。這意味著我們的指導範圍意味著貨幣收入在中點持續增長約 3.5%。

Moving to the other components of guidance on Slide 17. We expect adjusted gross margin to be in the low to mid-60% range, which is modestly lower than where we finished 2022. As I've talked about previously, much of the inflationary impacts from 2022 were held in inventory and therefore, have a greater impact to our cost of goods sold this year in 2023.

轉到幻燈片 17 中指導的其他組成部分。我們預計調整後的毛利率將處於 60% 的低至中等範圍內，略低於我們 2022 年結束時的水平。正如我之前所說，通貨膨脹的大部分2022 年的影響保留在庫存中，因此對我們今年 2023 年的銷售成本產生更大影響。

On operating expenses, our ranges for SG&A and R&D as a percentage of sales are in line with what we guided to and delivered in 2022 and reflect continued investment in the business as we position it for future growth. Our estimate for R&D expense includes line of sight to about $40 million of IPR&D expense that's tied to the $8 million investment we made in Claria Medical in January plus an estimate for a milestone achievement for ebopiprant in 2023. Any upfront payments related to future business development would be incremental, and we would call that out in our announcement of any such transactions. Those OpEx assumptions would bridge you to an adjusted EBITDA margin in the range of 31% to 33% for 2023.

在運營費用方面，我們的 SG&A 和 R&D 佔銷售額的百分比範圍與我們在 2022 年指導和交付的目標一致，並反映了我們在為未來增長定位時對該業務的持續投資。我們對研發費用的估計包括與我們 1 月份對 Claria Medical 的 800 萬美元投資相關的約 4000 萬美元 IPR&D 費用的預期，以及對 ebopiprant 在 2023 年取得里程碑式成就的估計。與未來業務發展相關的任何預付款將是增量的，我們會在任何此類交易的公告中指出這一點。這些 OpEx 假設將使您在 2023 年達到 31% 至 33% 的調整後 EBITDA 利潤率。

For below-the-line items, given the increasing interest rate environment, we have increased our estimate of interest expense for 2023 to approximately $510 million. The knock-on effect of higher interest expense also means that we had a cap with regard to interest expense deductibility for tax purposes. For 2022, we actually finished on the low end of our tax expense guidance range. So for 2023, our non-GAAP effective tax rate range reflects a normalization of expectations for tax expense, plus incremental expense for limitation of interest expense deductibility.

對於線下項目，鑑於利率環境不斷上升，我們將 2023 年的利息支出預估上調至約 5.1 億美元。更高利息支出的連鎖反應也意味著我們對出於稅收目的的利息支出扣除額設置了上限。對於 2022 年，我們實際上完成了稅收支出指導範圍的低端。因此，對於 2023 年，我們的非 GAAP 有效稅率範圍反映了對稅收費用預期的正常化，以及限制利息費用扣除額的增量費用。

Wrapping up the financial discussion, 2022 was a very solid year for the company. In addition to all the operating accomplishments Kevin mentioned, as we advance Organon's mission in Women's Health, on the financial front, we delivered constant currency revenue growth of 4%, which is well aligned with the mid-single-digit expectation we had for the year. We deployed over $200 million of capital across 4 promising transactions to drive future revenue growth. We proactively retired $100 million of debt. And we returned $290 million in cash dividends to shareholders.

總結財務討論，2022 年對公司來說是非常穩健的一年。除了 Kevin 提到的所有運營成就外，隨著我們推進 Organon 在女性健康領域的使命，在財務方面，我們實現了 4% 的持續貨幣收入增長，這與我們對年。我們在 4 項有前途的交易中部署了超過 2 億美元的資金，以推動未來的收入增長。我們主動償還了 1 億美元的債務。我們向股東返還了 2.9 億美元的現金股息。

We're looking forward to 2023, where we expect to deliver continued growth and strong capital performance based on the earnings guidance we're providing today.

我們期待著 2023 年，我們希望根據我們今天提供的收益指引實現持續增長和強勁的資本績效。

With that, we'll now turn the call over to Q&A.

有了這個，我們現在將把電話轉到問答環節。

(Operator Instructions) Your first question is from the line of Terence Flynn with Morgan Stanley.

（操作員說明）你的第一個問題來自摩根士丹利的 Terence Flynn。

I guess just as we think about Nexplanon on for 2023. Can you just walk us through how you're thinking about what's embedded in guidance, both on the U.S. side and ex U.S.? And then Follistim was somewhat soft this quarter. I was just wondering if there's anything of note there and then how we should think about that product on the forward as we go into first half of this year?

我想就像我們考慮 2023 年的 Nexplanon 一樣。您能否向我們介紹一下您是如何考慮美國和美國以外的指南中嵌入的內容的？然後 Follistim 在本季度有些疲軟。我只是想知道那裡是否有什麼值得注意的地方，然後在我們進入今年上半年時我們應該如何考慮該產品？

Thanks for the question, Terence. I'll take that. Look, as we start to think forward in terms of what we're doing with Nexplanon. We're very pleased with 2 consecutive years of double-digit performance. Of course, we had somewhat of a strong buy-in in the fourth quarter of last year. So we expect the first quarter as usual to be a little bit soft. But ultimately, going forward, we see really very strong, at least in the U.S. as well as ex U.S., very strong demand growth coming in terms of physician demand growth, we're able to kind of pick up and monitor now that we feel very good about the fact that the chances of Nexplanon continuing to growing in a very solid way is something that we feel very good about. Our ex U.S. business continues to grow because of the fact that it was very deprioritized in years past, and we have opportunities to really continue to drive access and ultimately awareness of Nexplanon throughout the world. And of course, when we start to go outside of the U.S., you start to see more kind of a lumpiness to the overall orders because there's a lot more tender business that's being involved here. But when you look at the U.S., we're really very happy with what we're seeing in terms of our DTC campaigns, our social media campaigns and all the things that we're doing in terms of our clinical training programs and continuing focus on really kind of driving prescription depth and physicians who are currently very comfortable with Nexplanon.

謝謝你的問題，特倫斯。我會接受的。看，當我們開始思考我們正在用 Nexplanon 做什麼時。我們對連續 2 年兩位數的業績感到非常滿意。當然，我們在去年第四季度獲得了一些強勁的支持。所以我們預計第一季度會像往常一樣有點疲軟。但最終，展望未來，我們看到非常強勁的需求增長，至少在美國和美國以外，在醫生需求增長方面非常強勁的需求增長，我們現在能夠有點回升和監控，因為我們覺得Nexplanon 繼續以非常穩固的方式增長的機會這一事實讓我們感到非常高興。我們的前美國業務繼續增長，因為它在過去幾年中被嚴重忽視，我們有機會真正繼續推動全球對 Nexplanon 的訪問並最終提高其知名度。當然，當我們開始走出美國市場時，你會開始看到整體訂單更加混亂，因為這裡涉及更多的招標業務。但是當你看看美國時，我們對我們在 DTC 活動、社交媒體活動以及我們在臨床培訓計劃和持續關注方面所做的所有事情感到非常高興關於真正推動處方深度和目前對 Nexplanon 非常滿意的醫生。

In terms of Follistim that you were asking in terms of the -- I guess, was the fourth quarter softness in terms of Follistim. Look, we have very strong Follistim growth in the U.S. performance, but ultimately, the softness came in Q4 from China. As you can well imagine, when China started to lock down and then ultimately after the lockdown, you start to have a real increase in terms of COVID infections. It really started to inhibit the opportunity for couples to go to the IVF clinics in order to be able to get their therapy. But we expect that to ultimately turn around in this year. We expect a very strong Follistim business in China for this year as we start to rebound from all the COVID lockdowns and, ultimately, the COVID infections that are essentially kind of burning through China as we see it today. I hope that answers your questions.

就 Follistim 而言，你問的是——我想，是 Follistim 第四季度的疲軟。看，我們的 Follistim 在美國的表現非常強勁，但最終，疲軟來自中國的第四季度。正如您所想像的那樣，當中國開始封鎖並最終在封鎖之後，就 COVID 感染而言，您開始真正增加。它真的開始抑制夫婦去試管嬰兒診所接受治療的機會。但我們預計這種情況最終會在今年出現好轉。我們預計今年 Follistim 在中國的業務會非常強勁，因為我們開始從所有 COVID 封鎖中反彈，最終，正如我們今天看到的那樣，COVID 感染基本上在中國蔓延。我希望這能回答你的問題。

Your next question is from the line of Umer Raffat with Evercore.

你的下一個問題來自 Evercore 的 Umer Rafat。

Maybe a couple, if I may. First, on 2023 guidance, could you clarify how much Humira in the number or not as well as sort of the ongoing China reopening and sort of what you've baked in? I think that will be very helpful.

也許一對，如果可以的話。首先，關於 2023 年的指導意見，您能否澄清一下 Humira 的數量，以及中國正在進行的重新開放以及您已經融入了什麼？我認為這將非常有幫助。

Well, we don't -- good to talk to you, but we don't usually kind of talk about exactly sales numbers, some individual products from Humira or for Hadlima, but we feel very good that this coming year will be a solid year for Hadlima on a few fronts: one, Canada and Australia continue to do very well in terms of their overall continuing progression in terms of their performance, strong double-digit growth outside of the U.S. for Hadlima; and second, we'll have half a year of Hadlima sales when we're in the U.S. I've been saying this for some time, 2023 will be more of a race to get on formularies of the top PBMs in the country as well as potentially some of the closed systems like Kaiser, other HMOs and also governments like the (inaudible).

好吧，我們不 - 很高興與你交談，但我們通常不會談論確切的銷售數字，Humira 或 Hadlima 的一些個別產品，但我們感到非常高興來年將是堅實的Hadlima 在幾個方面的一年：第一，加拿大和澳大利亞在整體持續進步方面繼續表現出色，Hadlima 在美國以外的地區實現了兩位數的強勁增長；其次，當我們在美國時，我們將有半年的 Hadlima 銷售。我已經說過一段時間了，2023 年將更像是一場爭奪該國頂級 PBM 處方集的競賽可能是像 Kaiser 這樣的一些封閉系統、其他 HMO 以及像（聽不清）這樣的政府。

So it is something that we feel very comfortable about that we'll do well because of the product presentation. As I mentioned in my commentary, in terms of the introductory commentary, you really want a product, and we believe the products that are going to win are ones that are the closest to the originator. We are about as close as one can get in terms of having the high concentration citrate-free, low concentration. We're talking about the frictionless experience with the device and pen, strong ex U.S. real-world evidence so that PBMs can feel comfortable about the safety and security of what they're using in terms of this product. So we feel very good about Hadlima going forward in terms of what we're doing there.

因此，由於產品展示，我們會做得很好，這讓我們感到非常自在。正如我在評論中提到的，就介紹性評論而言，你真的想要一個產品，我們相信將獲勝的產品是最接近原創者的產品。就高濃度無檸檬酸鹽、低濃度而言，我們已經接近了。我們談論的是設備和筆的無摩擦體驗，這是美國真實世界的有力證據，因此 PBM 可以對他們使用的產品的安全性和保障感到放心。因此，就我們在那裡所做的事情而言，我們對 Hadlima 的未來感到非常滿意。

And regarding China coming back, look, we've got really good growth drivers in China. As I mentioned earlier to Terence, we've got Fertility recovering, we've got the Marvelon business that is continuing to really ramp up very, very well. We've got the retail business starting to come back online because people are coming back to that. We've got the online business going very well. So that will offset some of the big headwinds that we're facing with the seventh round and ultimately, hopefully, we'll see what happens in the eighth round that is estimated for the Q2 period. But we feel very good that we'll be able to offset. And we've never had a year right now recently with the recent rounds of VBP where we've actually started to see a decline. We continue to grow in China. And as we get through 2023, we estimate anywhere between 70% to 80% of our business will have gone through the volume-based procurement business -- procurement's impact. And then we see growth, really strong robust growth after 2023. So 2024 and beyond, don't be surprised if you start to see high single-digit, low double-digit performance coming out of China.

關於中國回歸，看，我們在中國有非常好的增長動力。正如我之前對特倫斯提到的，我們的生育力正在恢復，我們的 Marvelon 業務正在繼續非常非常好地增長。我們已經讓零售業務開始重新上線，因為人們正在回歸。我們的在線業務進展順利。因此，這將抵消我們在第七輪中面臨的一些巨大阻力，最終，希望我們能看到估計在第二季度期間發生的第八輪會發生什麼。但我們感覺很好，我們將能夠抵消。最近幾輪的 VBP 我們最近從未有過一年，我們實際上已經開始看到下降。我們在中國繼續發展。到 2023 年，我們估計我們 70% 到 80% 的業務將經歷基於數量的採購業務——採購的影響。然後我們看到增長，2023 年後真正強勁的增長。因此，到 2024 年及以後，如果你開始看到中國出現高個位數、低兩位數的表現，請不要感到驚訝。

Kevin, sorry, if I may just clarify. I think on China, was. So I understand most of the products have gone through VBP. I guess what I was getting at was the pace of VBP rollout got paused during COVID in China. So with Zetia (inaudible) about $300 million run rate by (inaudible), et cetera. I'm just trying to understand how are you guys thinking about step down on these sort of $300 million, $400 million franchises in China as rollout resumes on the previously conducted VBP? And what's on the guidance?

凱文，抱歉，請允許我澄清一下。我認為在中國，是。所以我知道大部分產品都經過了 VBP。我想我的意思是 VBP 推出的步伐在中國的 COVID 期間暫停了。因此，Zetia（聽不清）的運行率（聽不清）約為 3 億美元，等等。我只是想了解你們是如何考慮在之前進行的 VBP 恢復推出時放棄這些價值 3 億美元、4 億美元的中國特許經營權的？指南上有什麼？

Yes. Well, look, I mean, you bring up a good point. The Round 7 was delayed by a few quarters. And so ultimately, that benefited us last year from Ezetrol business in China. Now it effectively went into effect November. So we are seeing the expected erosion of Ezetrol as we speak right now, probably about a $90 million headwind this year from volume-based procurement for Ezetrol in China. The remaining products that we expect to go through volume-based procurement Round 8 and Round 9, essentially are much smaller products. They're somewhere in the $40 million range.

是的。嗯，聽著，我的意思是，你提出了一個很好的觀點。第 7 輪比賽被推遲了幾個季度。因此，最終，我們去年從中國的 Ezetrol 業務中受益。現在它實際上於 11 月生效。因此，正如我們現在所說的，我們看到了 Ezetrol 的預期侵蝕，今年 Ezetrol 在中國的批量採購可能帶來約 9000 萬美元的逆風。我們預計將通過第 8 輪和第 9 輪批量採購的其餘產品基本上是小得多的產品。它們在 4000 萬美元左右。

So if that -- as you say, if there is the opportunity that those get delayed because of further ongoing COVID infections or whatever could be the things that come as a result of what's happened last year, then the upside won't be great at, say, for example, the delay that we saw with Ezetrol. That's why I mentioned it could be anywhere between, say, 70% and 80%, depending on those rounds happening in the second and fourth quarter, but they're much smaller products. So we went through most of the rounds that have kind of hit the big products have already happened. Does that answer your question, Umer?

因此，如果那樣——正如你所說，如果有機會因為 COVID 感染的進一步持續或去年發生的事情可能導致的任何事情而推遲，那麼上行空間就不會很大，例如，我們在 Ezetrol 中看到的延遲。這就是為什麼我提到它可能介於 70% 和 80% 之間，具體取決於第二季度和第四季度發生的那幾輪，但它們的產品要小得多。所以我們經歷了大部分已經發生的大產品的回合。這是否回答了你的問題，Umer？

Thank you so much, Kevin.

非常感謝你，凱文。

Kevin, just to quickly revisit for Umer's benefit. In the prepared comments, back to Hadlima for a second, Umer, we did say worldwide sales would not exceed about 1.5 points of Organon's consolidated revenue. And while Canada and Australia are important markets, they're a lot smaller than the U.S. So you can assume that, that number is weighted towards the United States a bit.

凱文，只是為了烏默爾的利益而快速重訪。在準備好的評論中，再回到 Hadlima，Umer，我們確實說過全球銷售額不會超過 Organon 綜合收入的 1.5 個百分點。雖然加拿大和澳大利亞是重要的市場，但它們比美國小得多。所以你可以假設，這個數字稍微偏向於美國。

Next question is from the line of Navann Ty with BNP Paribas Exane.

下一個問題來自 BNP Paribas Exane 的 Navann Ty。

I have a few starting on Nexplanon in the U.S. Do you expect to continue to take market share following the Dobbs news and from both the oral pill and IUDs? And can you share how many health care professionals do you expect to train this year? And also, am I right that there was no Nexplanon tender in the fourth quarter outside of the U.S. and do you expect a tender in Q1? And then separately, do you have a net leverage target that you can share? And could we see some term loan prepayment in 2023?

我有一些在美國開始使用 Nexplanon。您是否希望在 Dobbs 新聞之後以及口服藥和宮內節育器中繼續佔據市場份額？您能否分享您預計今年將培訓多少醫療保健專業人員？而且，我說的對嗎，美國以外的第四季度沒有 Nexplanon 招標，你預計第一季度會有招標嗎？然後，您是否有可以分享的淨槓桿目標？我們能否在 2023 年看到一些定期貸款提前還款？

So let me start with the Nexplanon questions. You're right, Navann, in Q4 of '21, we saw a big tender from Mexico. That tender came through in Q3 of '22. So that's why you didn't see really the tender business for the ex U.S. business in Q4. We do expect probably in the Q3, Q4 time frame, more of the tender business kind of ramping up in the emerging markets, whether that be in Mexico or Brazil and others. So you look for that probably in the second half of this year, we'll start to see bigger tender activities coming through in the year. In regards to Nexplanon and kind of the post Roe v. Wade opportunities, we do see, and I've been able to see that actually with Nexplanon in the U.S., what I would call those states that have restrictive policies around abortion or around access, we're seeing about a high single-digit growth for Nexplanon in those states. Those that are kind of more kind of protective of the opportunities are probably mid-single-digit growth rates right now, at least that's what we saw post the decision versus pre. So I do see that there's opportunities to continue to grow. I've always felt that, that when we think about what physicians and patients are going to be wanting in states where it's quite restrictive, I would think that real-world efficacy, and I mentioned, 99% effective, you take the decision-making out of the daily issues in regards to their contraception needs. And I do feel that we'll continue to see additional growth kind of accelerating from some of these states that ultimately have restricted policies.

那麼讓我從 Nexplanon 問題開始。你是對的，Navann，在 21 年的第四季度，我們看到了來自墨西哥的大型招標。該招標是在 22 年第三季度通過的。所以這就是為什麼你在第四季度沒有真正看到前美國業務的招標業務。我們確實預計可能在第三季度、第四季度的時間框架內，更多的招標業務會在新興市場興起，無論是在墨西哥、巴西還是其他國家。所以你可能會在今年下半年尋找它，我們將開始看到今年進行更大規模的招標活動。關於 Nexplanon 和羅伊訴韋德案後的機會，我們確實看到了，而且我已經能夠在美國看到 Nexplanon，我稱之為那些對墮胎或訪問有限制性政策的州，我們看到 Nexplanon 在這些州實現了高個位數的增長。那些更能保護機會的人現在可能是中等個位數的增長率，至少這是我們在決定後與決定前看到的。所以我確實看到有繼續增長的機會。我一直覺得，當我們考慮醫生和患者在限制性很強的州想要什麼時，我會認為現實世界的療效，我提到過，99% 有效，你做出決定——解決有關避孕需求的日常問題。而且我確實認為，我們將繼續看到這些最終實施限制政策的州中的一些正在加速增長。

And the last question in regards to clinical training programs. We did -- as I mentioned, in 2022, we trained 20,000 health care providers. Now that could be physicians, nurses, PAs, many of those. Some of those actually were retraining for people that needed to kind of get refamiliarized as the COVID lockdown -- or as people start to come back into the clinics. But we'll continue to invest in clinical training programs going forward. I would say there's going to be an average of anywhere between 15,000 and 20,000 per year that we'll be averaging going forward for health care providers, both new to prescribing Nexplanon and those that need refresher trainings in order to be able to feel more comfortable with inserting and using Nexplanon and with follow-on reviews.

關於臨床培訓計劃的最後一個問題。我們做到了——正如我提到的，在 2022 年，我們培訓了 20,000 名醫療保健提供者。現在可能是醫生、護士、私人助理等等。其中一些實際上是在為需要重新熟悉 COVID 封鎖的人進行再培訓——或者當人們開始回到診所時。但我們將繼續投資於未來的臨床培訓計劃。我會說每年平均有 15,000 到 20,000 名醫療保健提供者，我們將為醫療保健提供者提供服務，包括開 Nexplanon 處方的新手和需要進修培訓才能感覺更舒服的人插入和使用 Nexplanon 以及後續評論。

And I can take the part of the question related to leverage. So since the spin-off, we've been soft targeting a net leverage figure of 3.5x, the business had worked its way down to that level during the course of 2022, mainly related to the favorability we saw on the euro-denominated debt as the dollar strength. And then that will -- that's one of the dynamics that's reversing in 2023. We called that out in the prepared comments. But around that 3.5x leverage target, as we think about 2023, we will be balancing the benefits of voluntary debt reduction against what we see as the business development target landscape and our ability to increasingly self-fund our own deals as the year goes on, our cost of debt has risen. So we will continue, I think, Navann, to behave as we've done since the spin and we'll look to bring balance to that. As I said in the prepared comments, the hurdle, sort of the bar has risen as business development competes for capital against the near term and certain benefits of debt reduction.

我可以參與與槓桿相關的問題。因此，自分拆以來，我們一直將淨槓桿率目標定為 3.5 倍，該業務在 2022 年期間一直降至該水平，這主要與我們看到的對歐元計價債務的青睞有關隨著美元走強。然後這將 - 這是 2023 年逆轉的動力之一。我們在準備好的評論中指出了這一點。但圍繞 3.5 倍的槓桿率目標，正如我們考慮的 2023 年，我們將平衡自願減債的好處與我們所看到的業務發展目標格局以及我們隨著時間的推移越來越多地為自己的交易提供自籌資金的能力，我們的債務成本上升了。因此，我認為，Navann，我們將繼續像自旋轉以來所做的那樣行事，我們將尋求平衡。正如我在準備好的評論中所說的那樣，隨著業務發展與近期和債務削減的某些好處爭奪資本，障礙，某種程度上的障礙已經上升。

Your next question is from the line of David Amsellem with Piper Sandler.

您的下一個問題來自 David Amsellem 與 Piper Sandler 的合作。

I had a few. First, on the revenue bridge for '23 guidance. Regarding the volume growth, can you talk about the extent to which that's coming from Established Brands? And maybe talk in more detail about where the drivers are in Established Brands as you think about volume? That's number one.

我有幾個。首先，關於 23 年指導的收入橋樑。關於銷量增長，您能否談談這在多大程度上來自知名品牌？也許在考慮銷量時更詳細地談談驅動因素在知名品牌中的位置？這是第一。

Number two is, I apologize if I missed this, but just remind us when you think you can get interchangeability in the U.S. for Hadlima and just talk about progress towards that?

第二，如果我錯過了這一點，我深表歉意，但請提醒我們，當你認為你可以在美國獲得 Hadlima 的互換性並談談這方面的進展時？

And then lastly, on business development. I think you talked about a lean towards the acquisition of EBITDA-generating assets. I wanted to pick your brands on that and see what your appetite is in terms of commercial stage assets vis-a-vis development stage assets and how you're thinking about that?

最後，關於業務發展。我想你談到了傾向於收購產生 EBITDA 的資產。我想選擇你的品牌，看看你對商業階段資產與開發階段資產的興趣是什麼，你是如何考慮的？

So I can deal -- I can address the first 2 questions in regards to volume. Where is the volume growth coming in 2023 to the bridge. We do definitely see volume-based procurement -- non-volume-based procurement products. So these are -- they're not part of the list. So that will continue to be a driver. The retail sector in China will be -- continue to be a driver. Atozet continues to grow very well for us in Europe and now in China as well. Respiratory products continue to grow very nicely in terms of our overall volume growth. So you see that -- and then we've got some of the other smaller countries. And from a regional perspective, our Latin America, Middle East, Africa and Russia business continues to grow pretty robustly in terms of our own volume growth opportunities. So there are continuing volume growth chances that we'll see that continue for Established Brands. And then, of course, we talked about some of the downsides in regards to the China VBP rounds that -- ultimately offset some of the growth opportunities that we have for volume.

所以我可以處理——我可以解決前兩個關於數量的問題。 2023 年橋樑的銷量增長在哪裡。我們確實看到了基於數量的採購——非基於數量的採購產品。所以這些 - 它們不在列表中。所以這將繼續成為一個驅動因素。中國的零售業將 - 繼續成為推動力。 Atozet 繼續為我們在歐洲和現在的中國發展得很好。就我們的整體銷量增長而言，呼吸產品繼續增長得非常好。所以你看到了——然後我們還有其他一些較小的國家。從區域角度來看，我們的拉丁美洲、中東、非洲和俄羅斯業務在我們自身的銷量增長機會方面繼續強勁增長。因此，我們將看到知名品牌的數量持續增長的機會。然後，當然，我們談到了中國 VBP 輪次的一些不利因素——最終抵消了我們在數量方面的一些增長機會。

The second question that you had was, I believe, around -- what was it? The interchangeability, yes. So interchangeability, we expect that to come probably Q2, Q3 2024, so probably -- literally 1 year after launch as of July of this year, which is really around the range of where everybody -- at least many of the major competitors are going to have their interchangeability to come through. But I want to be clear, though, in my discussions with many of the PBMs, at least in the first year or 2, interchangeability was not a key point of differentiation. As long as you had it in process, as long as you had it within that you could kind of make sure that everybody understood, that you were going to be able to deliver into changeability within the reasonable time frame, that would kind of put off the table. Then we started to get into many other concepts or product delineations that ultimately means that we're much more compelling for them.

我相信你的第二個問題是——它是什麼？互換性，是的。所以互換性，我們預計它可能會在 2024 年第二季度、第三季度出現，所以很可能——實際上是在今年 7 月推出後 1 年，這實際上在每個人的範圍內——至少許多主要競爭對手都在進行使它們的互換性得以實現。但我想明確一點，在我與許多 PBM 的討論中，至少在第一年或第二年，互換性並不是差異化的關鍵點。只要你有它在過程中，只要你有它，你就可以確保每個人都理解，你將能夠在合理的時間範圍內實現可變性，這會有點推遲桌子。然後我們開始涉足許多其他概念或產品描述，這最終意味著我們對他們更具吸引力。

And then on biz dev M&A?

然後是商業開發併購？

Yes. So Matt, do you want to take that in terms of EBITDA? Second question that David has.

是的。那麼馬特，你想用 EBITDA 來衡量嗎？大衛的第二個問題。

Yes. Yes. So David, we've been seeking balance in the program between early, mid-, late-stage assets. We have had a preference to be looking at more latter stage or currently marketed opportunities. So as 2023 unfolds, don't be surprised if you see our capital deployed for business development slant towards things that are more near-term, especially since the last deal we did was Claria Medical, which is certainly early stage.

是的。是的。所以大衛，我們一直在尋求早期、中期、後期資產之間的計劃平衡。我們更傾向於關注更多的後期或當前市場上的機會。因此，隨著 2023 年的到來，如果您看到我們用於業務發展的資金傾向於更近期的事情，請不要感到驚訝，尤其是因為我們所做的最後一筆交易是 Claria Medical，這肯定處於早期階段。

Your next question is from the line of Chris Schott with JPMorgan.

你的下一個問題來自摩根大通的 Chris Schott。

Just 2 for me. Maybe first on Hadlima. Can you just talk at all about how you see the market evolving in 2024 and beyond, I guess, specifically, have there been any changes in terms of how you think about the size of the biosimilar market you're ultimately going to see here as you kind of think about where price is going to land and how much volume is ultimately going to be accessible for the biosimilars?

對我來說只有2個。也許首先是哈德利瑪。你能不能談談你如何看待 2024 年及以後的市場發展，我想，具體來說，你對生物仿製藥市場規模的看法是否有任何變化，你最終會在這裡看到您是否考慮過價格將下降到哪里以及生物仿製藥最終可以獲得多少數量？

And then my second question, and Matt, I know I've asked this in the past, but when we think about the EBITDA margins you're laying out for 2023, do these -- can we kind of think about these starting to represent kind of a trough level of margins and that -- as maybe top line growth continues over the next few years, we could start to see margin expansion from here? Or is there more investment that needs to go in the business to kind of really fund that longer-term kind of growth ambition that you have and that maybe we need to think about margins still kind of under pressure over time.

然後是我的第二個問題，馬特，我知道我過去曾問過這個問題，但是當我們考慮您為 2023 年制定的 EBITDA 利潤率時，做這些——我們可以考慮一下這些開始代表利潤率處於最低水平，而且 - 隨著未來幾年收入增長可能繼續，我們可以從這裡開始看到利潤率擴張嗎？或者是否需要更多的投資才能真正為您擁有的長期增長雄心提供資金，也許我們需要考慮隨著時間的推移利潤率仍然面臨壓力。

Thanks, Chris. I can deal with the Hadlima question, and I'll turn over the other question to Matt. Look, as I mentioned before, we believe that 2023, as you've seen from -- a couple of the PBMs are basically saying that they're going to allow, obviously, the originator. There's no preferential treatment there for biosimilars. And so as a result of that, when you're able to choose whatever you want, people will likely go to the originator at least in 2023. And so I believe that 2023 is going to be about which 2 to 3 biosimilars are going to get on to those formularies. And then we believe that our profile in terms of the high concentration citrate-free and the low concentration having the full profile, real-world evidence, patient-centric device, experience, by the way, with the immunology organization or rather immunology business and our deep, deep knowledge of rheumatology business across -- rheumatologists across the country, positions us an incredibly strong position to be 1 of those 2 to 3 products that are going to be listed on formulary.

謝謝，克里斯。我可以處理 Hadlima 的問題，我會把另一個問題交給 Matt。看，正如我之前提到的，我們相信 2023 年，正如你所看到的——一些 PBM 基本上說他們將允許，很明顯，發起者。那裡沒有針對生物仿製藥的優惠待遇。因此，當你能夠選擇任何你想要的東西時，人們可能至少會在 2023 年轉向原研藥。所以我相信 2023 年將有 2 到 3 個生物仿製藥將成為繼續使用那些處方集。然後我們相信，我們在高濃度無檸檬酸鹽和低濃度方面的概況具有完整的概況、真實世界的證據、以患者為中心的設備、經驗，順便說一句，與免疫學組織或更確切地說是免疫學業務和我們對風濕病業務的深入了解——全國各地的風濕病學家，使我們處於非常有利的地位，成為將要列入處方集的 2 到 3 種產品中的一種。

Now what will likely happen, obviously, in 2023, as I mentioned, this would be a lighter ramp-up year. You're going to be trying to fighting for formulary position. There will be obviously discounts that will be offered. I'm sure that the originators will be doing that in terms of kind of being more aggressive with discount.

現在很明顯，正如我提到的，2023 年可能會發生什麼，這將是一個較輕的增長年。您將嘗試為公式位置而戰。顯然會有折扣。我敢肯定，發起人會在打折方面更加激進。

Going forward, I do believe that volume will not retract. I think there will be opportunities not only for the switching of the Humira volume, but also, I do believe that PBMs will look at this opportunity for other such products, whether you're talking about other anti-TNFs where the opportunity is there to go to a biosimilar first. So the potential for volume and also, by the way, because of the lower price, you'll be able to get patients who weren't really essentially thought of for anti-TNF treatment, to be using now anti-TNF treatments. And so with high-quality anti-TNF biosimilars on the market, I think volume will be there. But the question is what kind of rebates, what kind of discounts that will be provided.

展望未來，我相信成交量不會回落。我認為不僅 Humira 量的轉換會有機會，而且，我相信 PBM 會為其他此類產品尋找這個機會，無論你是在談論其他有機會的抗 TNF 藥物先去生物仿製藥。因此，體積的潛力，順便說一下，由於價格較低，你將能夠讓那些基本上沒有考慮過抗 TNF 治療的患者現在使用抗 TNF 治療。因此，隨著市場上高質量的抗 TNF 生物仿製藥的出現，我認為數量將會很大。但問題是會提供什麼樣的返利，什麼樣的折扣。

Clearly, as we go forward in 2024 and 2025, there's going to be more of an expectation that the originator, the Humira will start to move off of formularies as we see in the rest of the world. And then you'll ultimately see bigger discounts being provided, but also ultimately, the volume opportunities will still exist. That's the way I see it. 2023 is a lighter ramp-up year, formulary accession. And then '24 and '25, it will start to open up bigger rebates, bigger discounts, but more volume opportunities for biosimilars. Matt?

顯然，隨著我們在 2024 年和 2025 年向前邁進，人們將更多地期望創始人 Humira 將開始擺脫處方，就像我們在世界其他地方看到的那樣。然後你最終會看到提供更大的折扣，但最終，批量機會仍然存在。這就是我的看法。 2023 年是較輕的增長年，公式加入。然後是 24 年和 25 年，它將開始為生物仿製藥提供更大的回扣、更大的折扣和更多的批量機會。馬特？

I'll take the second part of the question. So this is a dialogue that has been ongoing with investors really since the spin. When we launched our P&L had really 0 space in it for product development type expenses that could drive ongoing future revenue growth. And so we've been slowly and steadily reintroducing those as the quarters have evolved. And Chris, in direct answer to your question, when I think about the 31% to 33%, I think -- and how much lower that might go, it depends on how the -- how and what kind of business development that we do. But I would say, as we look at the range for 2023, the low side of that range is starting to feel like the nadir. Because at that -- at EBITDA margins like that, we've got R&D as a percentage of revenue that's right in that 9% to 10% range. We've got promotional-type expenses built into our SG&A that start to feel sustainable and ongoing. And at this point in time, with the kind of scenarios we've been running on what future business development might look like, the low side of that range is starting to feel like the nadir as we think about a 5-year strat plan horizon.

我將回答問題的第二部分。因此，這是自分拆以來一直與投資者進行的對話。當我們推出我們的 P&L 時，產品開發類型的費用實際上為 0，而這些費用可能會推動未來收入的持續增長。因此，隨著季度的發展，我們一直在緩慢而穩定地重新引入這些內容。克里斯，在直接回答你的問題時，當我想到 31% 到 33% 時，我認為 - 以及可能會降低多少，這取決於 - 我們的業務發展方式和類型.但我要說的是，當我們審視 2023 年的範圍時，該範圍的低端開始感覺像是最低點。因為那樣 - 在這樣的 EBITDA 利潤率下，我們的研發佔收入的百分比正好在 9% 到 10% 的範圍內。我們在 SG&A 中內置了促銷型費用，這些費用開始變得可持續和持續。在這個時間點，根據我們一直在運行的未來業務發展可能是什麼樣的場景，當我們考慮 5 年戰略計劃時，該範圍的低端開始感覺像是最低點.

Your next question is from the line of Chris Shibutani with Goldman Sachs.

你的下一個問題來自高盛的 Chris Shibutani。

This is [Dan] on for Chris. Just a couple, first on just business development with regards to biosimilars. I guess should we think about you guys as potentially competing on some of the other biologics that are -- potentially lose patent over the course of the decade. And if so, doing deal similar to the Samsung deal kind of the 50-50 split? And then just on cash flow for '23, just want to confirm, should we think of this year as still kind of somewhat onetime impacted but close to the $1 billion plus number and then $1 billion plus starting in '24? Or is the '23 kind of above -- in kind of the $1 billion-plus range?

這是克里斯的 [Dan]。只是一對夫婦，首先是關於生物仿製藥的業務發展。我想我們是否應該將你們視為可能與其他一些生物製劑競爭——可能會在十年內失去專利。如果是這樣，是否會進行類似於三星交易的 50-50 拆分交易？然後只是關於 23 年的現金流，只是想確認一下，我們是否應該認為今年仍然有點受到一次性影響但接近 10 億美元以上的數字，然後從 24 年開始超過 10 億美元？還是 23 年以上——在 10 億美元以上的範圍內？

So [Dan], let me address the business development strategy for biosimilars. Look, we're very much committed to biosimilars. Obviously, we're launching our Humira biosimilar in a few months from now. But we're also -- we made the deal with Shanghai Henlius to bring in 3 other -- 2 other biosimilars and the potential opportunity to get into the Yervoy biosimilar race as well.

所以 [Dan]，讓我談談生物仿製藥的業務發展戰略。看，我們非常致力於生物仿製藥。顯然，我們將在幾個月後推出 Humira 生物仿製藥。但我們也——我們與上海復宏漢霖達成協議，引入另外 3 種——2 種其他生物仿製藥，並有機會進入 Yervoy 生物仿製藥競賽。

Look, for us, it is a key. The key is order of entry. And so rest assured, we are looking at every major potential opportunity when it comes to doing business development. And we've got a lot of ongoing discussions as we speak. So high probability of success in terms of getting to market. As long as your order of entry is in the first tranche of launches, you can do very well. And that sales curve can last anywhere between 3 and 6 years.

看，對我們來說，這是一把鑰匙。關鍵是進入順序。所以請放心，在業務發展方面，我們正在尋找每一個主要的潛在機會。在我們發言時，我們正在進行很多討論。就進入市場而言，成功的可能性很高。只要你的進入順序在第一批發射中，你就可以做得很好。這條銷售曲線可以持續 3 到 6 年。

Look at Renflexis. We still grow double digit with Renflexis after 5 years of launch in the U.S.. So -- and that's our largest biosimilar to date in terms of our sales. We expect Hadlima to ultimately, when peak starts to emerge for Hadlima sales, to be the second largest product for Organon. So you can kind of see that we see an opportunity. And in terms of profit sharing or rather margins, we're going to do our best, as you can well imagine to continue to do the best we can for our shareholders and the best we can for what we bring to the market. So we'll continue to swing away at bringing more and more to the market for what we do with biosimilars.

看看 Renflexis。在美國推出 5 年後，Renflexis 的銷售額仍保持兩位數增長。因此——就銷售額而言，這是迄今為止我們最大的生物仿製藥。我們預計 Hadlima 最終會在 Hadlima 銷售高峰開始出現時成為 Organon 的第二大產品。所以你可以看到我們看到了一個機會。就利潤分享或利潤率而言，我們將盡最大努力，正如你可以想像的那樣，繼續為我們的股東盡我們所能，為我們帶給市場的東西盡我們所能。因此，我們將繼續努力將越來越多的生物仿製藥推向市場。

And then on the subject of free cash flow, we spent some time talking about it in the prepared comments. When you look at our performance this year, were it not for that working capital build that was spin related, you would have seen us in the north of $1 billion range before onetime items. We think that improves a little bit during the course of 2023. But we will still have onetime costs of about the same magnitude as we saw them in 2022. And that as we're moving into the latter stages of the TSA agreement with Merck. We are right on target. We are ticking off and standing up all the activities we need to. The biggest driver now of onetime cost is our global ERP implementation. That's one of the biggest drivers of the onetime cost in 2023.

然後關於自由現金流的問題，我們花了一些時間在準備好的評論中討論它。當您查看我們今年的業績時，如果不是因為與旋轉相關的營運資本建設，您會看到我們在一次性項目之前處於 10 億美元範圍的北部。我們認為這種情況在 2023 年期間會有所改善。但我們的一次性成本仍將與 2022 年的規模大致相同。而且隨著我們進入與默克公司的 TSA 協議的後期階段。我們正中目標。我們正在勾選並開展我們需要開展的所有活動。現在一次性成本的最大驅動因素是我們的全球 ERP 實施。這是 2023 年一次性成本的最大驅動因素之一。

Your next question is from the line of Steve Scala with Cowen.

你的下一個問題來自 Steve Scala 與 Cowen 的對話。

I have 2 questions. Nexplanon missed double-digit growth expectation set early in 2022. And those expectations were reiterated at midyear and never stated to be a constant exchange. You mentioned some pushes and pulls, but presumably, they were anticipated 6 months ago. So what factors led to the shortfall in 2022 for Nexplanon? So that's the first question.

我有兩個問題。 Nexplanon 未能實現 2022 年初設定的兩位數增長預期。這些預期在年中得到重申，但從未表示會保持不變。您提到了一些推動和拉動，但據推測，它們是 6 個月前就已預料到的。那麼是什麼因素導致了 Nexplanon 在 2022 年的短缺？這是第一個問題。

The second question is similar to questions I've asked in the past, so apologies for asking again. But with the view that the future of the company is in Women's Health, the pace of Women's Health business development deals is strikingly low, 7 deals in 7 quarters of public existence. I know you won't do all 140 deals originally identified. But if you did, it would take 3 more decades to complete them all. Was this pace that we've seen always the plan? Or have things been more challenging than expected? In my humble opinion, I think the pace of activity in Women's Health needs to increase exponentially.

第二個問題與我過去問過的問題類似，所以很抱歉再次提問。但鑑於公司的未來在女性健康領域，女性健康業務發展交易的速度非常低，公開存在的 7 個季度中有 7 筆交易。我知道您不會完成最初確定的所有 140 筆交易。但是，如果您這樣做了，則需要再花 3 個十年才能完成所有這些工作。我們一直看到的這種步伐是計劃嗎？還是事情比預期更具挑戰性？以我的愚見，我認為女性健康領域的活動步伐需要呈指數級增長。

Good to talk to you, Steve. Let me address Nexplanon. We always basically signal to the world that we expect a double-digit growth. We achieved 11% growth in 2022. And that is always at a constant currency rather ex exchange basis because we don't know what's going to happen with currencies on a month-by-month basis. And it was kind of hard if you're talking about at the beginning of -- or rather at the end of last year to see what would happen with the dollar strengthening to the point where it was throughout the year, so on an ex-exchange basis, we did grow 11%. 8% in the U.S. The remainder outside of the U.S., ex U.S. business was responsible for 50% of our growth, so we're feeling very good about where we landed with Nexplanon. It's consistent to what we essentially have guided and the language that we've used. And in terms of your second question, in regards to the opportunities that exist right now in the Women's Health space. As I've mentioned earlier days, we look at Women's Health in -- from 3 points of view: one, with therapeutics; two, with potentially devices. We're agnostic on whether it's a device or therapeutic. And those are focused primarily -- uniquely for Women's Health-related conditions. But we're also looking at conditions that what we would consider disproportionately impact Women's Health and -- or women. And that would be anything from celiac disease, lupus, migraine, osteoporosis, the list goes on and on and on, chronic cough. So that's always a potential opportunity for us to use our capital allocation in our business development dollars.

很高興和你交談，史蒂夫。讓我來談談 Nexplanon。我們基本上總是向世界發出我們預計兩位數增長的信號。我們在 2022 年實現了 11% 的增長。這始終以不變的貨幣而非匯率為基礎，因為我們不知道每個月貨幣會發生什麼。如果你在年初或更確切地說是在去年年底談論美元走強到全年的水平會發生什麼，那麼在前 -按匯率計算，我們確實增長了 11%。 8% 在美國。其餘在美國以外的美國業務占我們增長的 50%，因此我們對與 Nexplanon 合作的進展感到非常滿意。它與我們基本上指導的內容和我們使用的語言一致。關於你的第二個問題，關於女性健康領域目前存在的機會。正如我早些時候提到的，我們從 3 個角度來看待女性健康：一是治療；二是治療。二，有潛在的設備。我們不知道它是設備還是治療。這些主要集中在——專門針對與女性健康相關的疾病。但我們也在研究我們認為會對女性健康和 - 或女性產生不成比例影響的情況。那可能是乳糜瀉、狼瘡、偏頭痛、骨質疏鬆症，慢性咳嗽等等。因此，這始終是我們將資本分配用於業務發展的潛在機會。

Now I will say to you, though, this is rare because most of the time that when I say we've done 8 deals in literally 1.5 years, that's almost a deal every 2 months. I would say that we feel very comfortable. And as you start to layer on some of these assets with the business -- organic business that we're driving with the opportunities that we have, not only in life cycle management opportunities, which are really plentiful but also with the biosimilar businesses that we're bringing in, we see an opportunity to really continue to grow the growth momentum for the company going forward in the future.

不過，現在我要告訴你，這很少見，因為大多數時候，當我說我們在 1.5 年內完成了 8 筆交易時，幾乎每 2 個月就有一筆交易。我會說我們感覺很舒服。當你開始將其中一些資產與業務分層時——我們正在利用我們擁有的機會推動的有機業務，不僅是生命週期管理機會，這些機會非常豐富，而且還有我們的生物仿製藥業務通過引入，我們看到了一個機會，可以真正繼續為公司未來的發展提供增長動力。

Your next question is from the line of Greg Fraser with Truist Securities.

你的下一個問題來自 Truist Securities 的 Greg Fraser。

Following up on BD. You've done a number of deals to expand the pipeline with assets for new indications beyond your core Women's Health business like endometriosis and preterm labor, and I know you're bullish on the potential of those programs. Are you looking to add additional programs for those indications so you have more shots on goal? Is that something investors should expect? Or are your BD efforts in the Women's Health more focused on (inaudible)?

跟進BD。您已經完成了多項交易，以擴大資產管道，以在您的核心女性健康業務（如子宮內膜異位症和早產）之外尋找新的適應症，我知道您看好這些項目的潛力。您是否希望為這些適應症添加額外的程序，以便您有更多的射門機會？這是投資者應該期待的嗎？還是您在女性健康方面的 BD 工作更側重於（聽不清）？

Well, I got to say that shots on goal is always a nice thing. The acquisition we had for Forendo has got a couple of molecules, our 6219 asset is the one that is furthest along, but they also have other backup compounds as well. We like the mechanism of action of this new product. With this new mechanism, it has great promise. So yes, I mean, wherever possible in terms of what we're making acquisitions. We'll see whether there's backup molecules that we potentially can take to the clinic if the -- our primary molecule fails, but we're also expanding, as you said, we went from essentially being in contraception and fertility to add a number of different therapeutic areas, postpartum hemorrhage, preterm labor, endometriosis, polycystic ovary syndrome, bacterial vaginosis, now with our device with Claria for minimally invasive laparoscopic hysterectomies. So there's a number of different areas we continually identify as opportunities that both meet a need in the market and need innovation in the market. And we believe that we're really very well primed to take on that leadership role.

好吧，我得說射門總是一件好事。我們對 Forendo 的收購有幾個分子，我們的 6219 資產是最遠的一個，但他們也有其他備用化合物。我們喜歡這種新產品的作用機制。有了這個新機制，它就有了很大的希望。所以是的，我的意思是，就我們正在進行的收購而言，只要有可能。我們會看看是否有備用分子，如果我們的主要分子失敗了，我們可能會把它們帶到診所，但我們也在擴大，正如你所說，我們從本質上是避孕和生育增加了一些不同的治療領域，產後出血，早產，子宮內膜異位症，多囊卵巢綜合徵，細菌性陰道病，現在我們的設備與 Claria 一起用於微創腹腔鏡子宮切除術。因此，我們不斷將許多不同的領域確定為既能滿足市場需求又需要市場創新的機會。我們相信，我們真的非常適合擔任領導角色。

And today's final question will come from the line of Jason Gerberry with Bank of America.

今天的最後一個問題將來自美國銀行的 Jason Gerberry。

This is [Bhavin Patel] on for Jason Gerberry. Just 2 questions. First, I wanted to get a sense of exploring growth outlook that's assumed in the 2023 top line guidance given that's something you provided in the past. I guess it is still double-digit growth. And then the second question is whether it's safe to assume that for non-plant to be active in M&A this year, given net leverage ratio considerations, do you expect to do a big deal in 2023?

這是 Jason Gerberry 的 [Bhavin Patel]。只有2個問題。首先，我想了解一下 2023 年頂線指南中假設的增長前景，因為這是您過去提供的。我猜它仍然是兩位數的增長。然後第二個問題是假設非廠今年積極併購是否安全，考慮到淨槓桿率，你預計2023年會做大交易嗎？

Thanks for the question. Look, I'd say that, first of all, I'm very happy and satisfied with the performance since we spun off 2 consecutive years of double-digit performance. Our focus in 2023, we're really going to be increasing our focus on patient demand. We'll, of course, we'll be pushing for a more robust as we can for the product. We continue to see ex-U.S. business growing faster than the U.S. business. We're continuing our clinical training programs, follow-on reviews, our DTC campaigns. So we believe that Nexplanon: a, we'll continue to grow robustly over the years; and second, we are also focusing on the fact that this is going to be our first $1 billion product essentially by the end of 2025. That's the run rate that we're going forward. We feel very good about that. And so this is going to be a long-term asset for us. January demand is strong in terms of our overall physician demand. So we feel really good about Nexplanon. I'll hand over the last question to Matt for answering.

謝謝你的問題。聽著，我要說的是，首先，我對我們連續 2 年取得兩位數業績的表現感到非常高興和滿意。我們在 2023 年的重點是，我們真的會更加關注患者的需求。當然，我們會盡我們所能推動產品更強大。我們繼續看到前美國。業務增長速度超過美國業務。我們將繼續我們的臨床培訓計劃、後續審查和 DTC 活動。所以我們相信 Nexplanon： a，我們將在未來幾年繼續強勁增長；其次，我們還關注這樣一個事實，即到 2025 年底，這將成為我們的第一個價值 10 億美元的產品。這就是我們前進的運行率。我們對此感覺很好。因此，這對我們來說將是一項長期資產。就我們的整體醫生需求而言，一月份的需求強勁。所以我們對 Nexplanon 感覺很好。我將把最後一個問題交給 Matt 來回答。

Yes. So we fielded this question a few times on deal size. And we've obviously had very good success with the smaller deals that we've been doing. They're plentiful. They're a little bit easier to integrate. The rising interest rate environment, our leverage ticking up does -- I would say, make deals incrementally more challenging at the margin. But with respect to big deals, we've always been in the same place, which is we're not necessarily outhunting them, but we are aware of possibilities we think creatively and we would not shy away from a larger opportunity if we really felt it was a compelling shareholder value creation. But we've got a lot of organic growth plans in place for 2023 as well as execution of the 8 deals that we've already done. So 2023 is going to be an exciting and busy year. But like I said, as far as big deals go, we're aware of them. We're open to them, but it's not necessarily something we see as either necessary for our success or a priority.

是的。所以我們就交易規模回答了這個問題幾次。我們顯然在我們一直在做的較小的交易中取得了非常好的成功。他們很豐富。它們更容易集成。利率上升的環境，我們的槓桿率上升確實 - 我會說，使邊際交易越來越具有挑戰性。但就大交易而言，我們始終處於同一個位置，即我們不一定要超越它們，但我們意識到我們創造性地思考的可能性，如果我們真的覺得我們不會迴避更大的機會這是一項引人注目的股東價值創造。但我們已經為 2023 年制定了許多有機增長計劃，並執行了我們已經完成的 8 筆交易。因此，2023 年將是激動人心且忙碌的一年。但就像我說的，就大交易而言，我們知道它們。我們對他們持開放態度，但這不一定是我們認為成功所必需或優先考慮的事情。

This concludes the Q&A session. I would now like to turn the call over to the company's CEO, Kevin Ali, for closing remarks.

問答環節到此結束。我現在想把電話轉給公司的首席執行官凱文阿里，讓他發表結束語。

Well, thank you for all the questions -- thoughtful questions. I do want to close by saying, look, today marks our seventh quarter of earnings as a stand-alone company. With the fourth quarter of 2022, we've continued our track record of delivering exactly what we set out to achieve. Our vision of a sustainable growing business is being realized. We have confidence in the portfolio we have in our hands today, and we believe in the potential of our growing pipeline of assets with the promise to address significant unmet medical needs, especially for women. I want to thank you for joining us today, and we look forward to communicating our progress with you in 2023. Thanks, everyone.

好吧，謝謝你提出的所有問題——深思熟慮的問題。最後，我確實想說，看，今天標誌著我們作為一家獨立公司的第七個季度的收益。到 2022 年第四季度，我們繼續保持著實現我們設定目標的良好記錄。我們正在實現可持續發展業務的願景。我們對我們今天擁有的投資組合充滿信心，我們相信我們不斷增長的資產管道的潛力，並有望解決未滿足的重大醫療需求，尤其是對女性的需求。我要感謝您今天加入我們，我們期待在 2023 年與您交流我們的進展。謝謝大家。

Thank you all for joining the Organon Fourth Quarter and Full Year 2022 Earnings Conference Call. We thank you for your participation. You may now disconnect.

感謝大家參加 Organon 第四季度和 2022 年全年收益電話會議。我們感謝您的參與。您現在可以斷開連接。