Organon & Co (OGN) 2024 Q1 法說會逐字稿

I'd like to welcome everyone to the Organon & Co., First Quarter 2024 Earnings Call and Webcast. (Operator Instructions) I would now like to turn the call over to Jennifer Halchak, Vice President of Investor Relations. You may begin.

歡迎大家參加 Organon & Co. 2024 年第一季財報電話會議及網路廣播。 （操作員說明）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 First Quarter 2024 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 and guidance. Also joining us for the Q&A portion of this call is Organon's Head of R&D, Juan Camilo Arjona Ferreira. Today, we will be referencing a presentation that will be visible during this call for those of you on our webcast.

謝謝你，接線生。大家，早安。感謝您參加 Organon 2024 年第一季財報電話會議。今天和我在一起的是 Organon 執行長 Kevin Ali，他將介紹策略和營運亮點；我們的財務長馬特沃爾什（Matt Walsh）將審查業績和指導。 Organon 的研發主管 Juan Camilo Arjona Ferreira 也參加了這次電話會議的問答部分。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。

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

本次電話會議結束後，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簡報。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 would 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 2024 first quarter results. We entered this year with a clear focus to deliver our 2024 financial targets, improving our financial position and positioning ourselves for future growth. And to that end, the first quarter was a very solid start. For the first quarter of 2024, revenue was $1.6 billion, with all 3 franchises contributing to a 7% growth rate at constant currency.

大家早安，謝謝你，Jen。歡迎參加今天的電話會議，我們將討論 2024 年第一季的業績。進入今年，我們的明確重點是實現 2024 年的財務目標，改善我們的財務狀況，並為未來的成長做好準備。為此，第一季是一個非常堅實的開始。 2024 年第一季度，營收為 16 億美元，所有 3 個特許經營權以固定匯率計算均貢獻了 7% 的成長率。

I'm pleased to report that the Women's health franchise grew 12%. Our Biosimilars franchise grew 46%, and our established brands business continued its stable performance with growth of 2%. In the first quarter, adjusted EBITDA was $538 million, representing a 33.2% adjusted EBITDA margin and adjusted diluted EPS was $1.22. The strong performance in the first quarter strengthens our conviction in our financial guidance for the full year 2024, and we are affirming those ranges.

我很高興地報告，女性健康業務成長了 12%。我們的生物相似藥特許經營權成長了 46%，我們的老牌品牌業務繼續保持穩定的表現，成長了 2%。第一季度，調整後 EBITDA 為 5.38 億美元，調整後 EBITDA 利潤率為 33.2%，調整後稀釋後每股收益為 1.22 美元。第一季的強勁表現增強了我們對 2024 年全年財務指引的信心，我們正在確認這些範圍。

We remain confident in our ability to deliver our third year of revenue growth on a constant currency basis, and we remain committed to delivering full year adjusted EBITDA margins that are in line with last year or better. From a capital allocation standpoint, we continue to believe this business can generate $1 billion of free cash flow before onetime costs, and we will be driving towards that number in 2024.

我們對在固定匯率基礎上實現第三年收入成長的能力仍然充滿信心，並且我們仍然致力於實現全年調整後的 EBITDA 利潤率與去年一致或更好。從資本配置的角度來看，我們仍然相信這項業務可以在一次性成本之前產生 10 億美元的自由現金流，我們將在 2024 年朝著這個數字邁進。

That strong cash flow will provide financial flexibility to comfortably service our dividend, make progress on achieving a leverage ratio below 4x by the end of 2024 and to continue to do business development in line with the types of transactions we have completed in the last couple of years. This includes transactions in biosimilars and the recent commercial agreement with Eli Lilly to license 2 migraine assets.

強勁的現金流將提供財務靈活性，以輕鬆支付我們的股息，在 2024 年底前實現槓桿率低於 4 倍方面取得進展，並繼續根據我們在過去幾年完成的交易類型進行業務發展年。這包括生物相似藥的交易以及最近與禮來公司簽署的商業協議，以許可 2 種偏頭痛資產。

These transactions have solid returns, but importantly, they're also aligned with our mission of offering solutions in women's health beyond the narrow definition of reproductive health. Moving on to discuss our franchise performance. The first quarter growth in women's health franchise was led by NEXPLANON. The last year, we took the appropriate actions to position NEXPLANON for successful 2024 and the long-term growth opportunity we see for the product. We remain confident that the product can achieve robust revenue growth in 2024. NEXPLANON's first quarter, constant currency growth was 34%.

這些交易具有豐厚的回報，但重要的是，它們也符合我們的使命，在生殖健康的狹隘定義之外提供女性健康解決方案。接下來討論我們的特許經營業績。女性健康特許經營第一季的成長由 NEXPLANON 引領。去年，我們採取了適當的行動，使 NEXPLANON 能夠在 2024 年取得成功，並獲得我們所看到的產品的長期成長機會。我們仍然對該產品能夠在 2024 年實現強勁的營收成長充滿信心。

The U.S. was up 35%, and the rest of the world was up 34%. Year-over-year growth in the U.S. reflected a shift in timing of our list price increase, which brought stability to distributor buying patterns. As a result of this shift, going forward, we expect less volatility quarter-to-quarter in NEXPLANON results. For the full year, we expect growth to be driven by NEXPLANON's leadership in contraception, the benefits of our pricing strategy, including list price in the U.S. and management of the 340B channel as well as physician demand growth.

美國上漲了 35%，世界其他地區上漲了 34%。美國的同比增長反映了我們的標價上漲時間的變化，這為經銷商的購買模式帶來了穩定性。由於這一轉變，展望未來，我們預計 NEXPLANON 業績的季度波動性將較小。對於全年而言，我們預計成長將由 NEXPLANON 在避孕領域的領導地位、我們定價策略的優勢（包括美國的標價、340B 管道的管理以及醫生需求的成長）推動。

Outside the U.S., NEXPLANON grew 34% ex-FX in the first quarter driven by the increased demand in the Lamera region and in the larger markets in the U.K. region like France, the U.K and Canada. Outside the U.S. for the full year of 2024 growth will be driven by continued strong performance in those markets as well as our ability to better meet increased demand in our access markets, which we cited as a priority for us in 2024. As I mentioned nearly every quarter, we believe NEXPLANON will be on a $1 billion annual run rate in 2025. And beyond 2025, we believe there is still significant runway for growth up until the loss of exclusivity for NEXPLANON in the U.S., which, in our view, will not occur until 2030 for 3 specific reasons.

在美國以外的地區，由於拉梅拉地區以及法國、英國和加拿大等英國地區較大市場的需求增加，NEXPLANON 第一季的剔除匯率增加了 34%。 2024 年美國以外地區的全年成長將受到這些市場持續強勁表現以及我們更好地滿足准入市場不斷增長的需求的能力的推動，我們將其視為 2024 年我們的首要任務。個季度的年營業額將在2025 年達到10 億美元。直到2030 年才會發生。

First, our 5-year study is on track to close this year and pending FDA review and approval, our planning assumption is that we will be able to market it with a 5-year label in 2026. A differentiated label will give us 3 years of data exclusivity on that 5-year duration of use claim, which we know from our market research is preferred by women and providers. Second, we have IP protection on aspects of the applicator device 2030. We believe that any generic coming to market before then would have to develop their own device and training programs to go along with it.

首先，我們的 5 年研究預計今年結束，正在等待 FDA 審查和批准，我們的計劃假設是我們將能夠在 2026 年以 5 年標籤上市。的數據排他性，我們從市場研究中得知，女性和提供者更喜歡這種說法。其次，我們對 2030 塗抹器設備的各個方面都有智慧財產權保護。

So it's not until 2030 when IP protection on both implant and device would have expired that we might see the market start to alter with a similar 5-year product and applicator. And third, complex drug device combinations have demonstrated strong post-LOE performance, which could be due to the fact complex drug device development can pose significant challenges in terms of showing therapeutic equivalents.

因此，直到 2030 年，植體和裝置的智慧財產權保護都到期時，我們可能會看到市場開始因類似的 5 年期產品和塗抹器而改變。第三，複雜藥物器械組合已表現出強大的 LOE 後性能，這可能是由於複雜藥物器械開發可能在顯示治療等效物方面提出重大挑戰。

So overall, we're confident in the sales longevity of Nexplanon and further, when competition does come, we do not expect a traditional generics erosion curve. Moving on to our fertility franchise. As expected, our global fertility business was essentially flat this quarter, down about $2 million or about 2% ex-FX. You'll recall that in the fourth quarter of 2023 in the U.S., we exited a spin-related commercial arrangement, and we onboarded a significant customer, resulting in a very strong buy in FOLLISTIM at the end of last year that we have largely worked through in the first quarter. Offsetting U.S. performance was strong growth in fertility in China, which grew double digits, benefiting from strong demand.

因此，總的來說，我們對 Nexplanon 的銷售壽命充滿信心，而且，當競爭真正到來時，我們預計傳統仿製藥不會出現侵蝕曲線。繼續我們的生育專營權。正如預期的那樣，本季我們的全球生育業務基本上持平，下降了約 200 萬美元，即扣除外匯因素約 2%。您會記得，在美國，2023 年第四季度，我們退出了一項與分拆相關的商業安排，並且我們引入了一位重要客戶，導致去年底對FOLLISTIM 進行了非常強勁的購買，我們已經在很大程度上開展了工作通過在第一季。受益於強勁的需求，中國生育率的強勁增長抵消了美國的表現，生育率增長了兩位數。

We expect continued momentum in our fertility business in China in 2024, with growth supported by solid demand especially in key provinces like Beijing, where reimbursement for assisted reproductive technologies has been implemented. Together, the U.S. and China make up north of 50% of our fertility business, strong demand in those markets, coupled with new launches and footprint expansion in other markets are supportive of the high single-digit revenue growth we expect to see in fertility on a global basis for the full year of 2024.

我們預計 2024 年我們在中國的生育業務將繼續保持成長勢頭，成長將受到強勁需求的支持，尤其是在北京等已實施輔助生殖技術報銷的重點省份。美國和中國合計占我們生育業務的 50% 以上，這些市場的強勁需求，加上新產品的推出和其他市場的足跡擴張，都支持我們預計生育業務將實現高單位數收入增長。的全球基礎。

Let's move now to our biosimilar business, which grew 46% in the first quarter and continues to be a solid growth pillar for Organon. We expect 2024 should be another year of double-digit growth on a global basis for our Biosimilars franchise. In the U.S., the growth driver in 2024 for Biosimilars will primarily be the uptake of HADLIMA for getting very good traction with HADLIMA with Veterans Affairs, who within 60 days of exclusively carrying HADLIMA managed to convert more than 50% of the patients from HUMIRA to HADLIMA. This is a strong indicator of payers' ability to rapidly convert utilization which is a critical factor for accelerating conversion to Biosimilars in this market. Behind the U.S., 2 other key markets in our Biosimilar business are Brazil and Canada.

現在讓我們談談我們的生物相似藥業務，該業務在第一季成長了 46%，並且仍然是 Organon 的堅實成長支柱。我們預計 2024 年我們的生物相似藥業務將在全球範圍內再次實現兩位數成長。在美國，2024 年生物相似藥的成長動力將主要是HADLIMA 的採用，因為HADLIMA 與退伍軍人事務部獲得了很好的牽引力，退伍軍人事務部在獨家攜帶HADLIMA 的60 天內成功地將超過50% 的患者從HUMIRA 轉變為哈德利馬。這是付款人快速轉化利用能力的有力指標，這是加速該市場轉化為生物相似藥的關鍵因素。除了美國之外，我們生物相似藥業務的另外兩個主要市場是巴西和加拿大。

In Brazil, we are seeing strong performance from ONTRUZANT, in particular. The fourth quarter of 2023 was very strong for ONTRUZANT, driven by favorable timing of a tender in Brazil, but in Q1, we saw incremental volumes come through that we would characterize as opportunistic upside. In Canada, we continue to see strong performance, especially in HADLIMA and RENFLEXIS as the government mandated province by province transition to Biosimilar progresses.

在巴西，我們尤其看到 ONTRUZANT 的強勁表​​現。由於巴西招標的有利時機，2023 年第四季度的 ONTRUZANT 表現非常強勁，但在第一季度，我們看到銷售增量，我們將其描述為機會性上漲。在加拿大，我們繼續看到強勁的表現，尤其是 HADLIMA 和 RENFLEXIS，因為政府強制各省向生物相似藥過渡取得了進展。

As we have previously talked about, our aim in Biosimilars is to launch a new asset every couple of years. We are well positioned to execute on that beyond 2024. A great example of this is our collaboration with Shanghai Henlius Biotech, where we licensed commercialization rights for 2 investigational products, PERJETA or pertuzumab and Prolia and XGEVA or denosumab biosimilar candidates. Organon will have exclusive global commercialization rights to these assets outside of Mainland China, Hong Kong, Macau and Taiwan. Clinical trials on both molecules have been progressing. In fact, we just recently announced that the Phase III comparative clinical trial for the denosumab biosimilar met primary endpoints.

正如我們之前談到的，我們在生物相似藥領域的目標是每隔幾年就會推出新資產。我們有能力在2024 年之後執行這一目標。抗以及Prolia 和XGEVA 或狄諾塞麥生物類似藥候選藥物。歐加農將擁有這些資產在中國大陸、香港、澳門和台灣以外地區的獨家全球商業化權利。這兩種分子的臨床試驗一直在取得進展。事實上，我們最近剛剛宣布，狄諾塞麥生物相似藥的 III 期比較臨床試驗達到了主要終點。

We expect regulatory filings for our 2 denosumab biosimilar candidates to occur during 2024 in certain markets, including the U.S. and EU followed by filings for the pertuzumab biosimilar candidate in the U.S. in late 2024 or early 2025. And then rounding out the discussion with established brands, which grew 2% ex FX in the first quarter. demonstrating the resilience of this business. Impact from VBP in China was more than offset by the initial contribution from the recent commercial agreement for the 2 migraine drugs Emgality and REYVOW.

我們預計我們的2 種地諾單抗生物相似藥候選藥物將於2024 年在某些市場（包括美國和歐盟）進行監管備案，隨後於2024 年底或2025 年初在美國提交帕妥珠單抗生物仿製藥候選藥物的備案。展示了該業務的韌性。 VBP 在中國的影響被近期兩種偏頭痛藥物 Emgality 和 REYVOW 商業協議的初步貢獻所抵消。

We also saw a recovery in our injectable steroid products following last year's market action. For full year 2024, we expect established brands to achieve flat performance on an ex-FX basis and Matt will go into more detail about the pushes and pulls on the established brands portfolio for 2024. Moving now to Slide 6, where we take a look at revenue by geography. EUCAN grew 10% ex-FX in the quarter driven by the addition of the 2 migraine assets and the recovery of injectable steroids, both of which I just mentioned. We're still having solid growth in ATOZET in Europe which should be the trend for the 9 months of the year until it loses exclusivity in late third quarter of this year. U.S. was up 14% in the quarter, driven by performance in NEXPLANON as well as uptake of both HADLIMA and JADA post-launch. These factors offset rate pressure and the channel dynamics in fertility, which benefited the fourth quarter of last year as well as U.S. performance of ONTRUZANT.

繼去年的市場行動之後，我們的注射類固醇產品也出現了復甦。對於 2024 年全年，我們預計知名品牌在扣除外匯因素後將實現持平業績，Matt 將更詳細地介紹 2024 年對知名品牌組合的推動和拉動。按地理位置劃分的收入。在我剛才提到的兩種偏頭痛資產的增加和注射類固醇的恢復的推動下，EUCAN 在本季度增長了 10%（除外匯外）。我們的 ATOZET 在歐洲仍然保持穩健成長，這應該是今年 9 個月的趨勢，直到今年第三季末失去獨家經營權。在 NEXPLANON 的表現以及 HADLIMA 和 JADA 發布後的採用的推動下，美國本季上漲了 14%。這些因素抵消了利率壓力和生育率的通道動態，這有利於去年第四季以及 ONTRUZANT 在美國的表現。

The LAMERA region has been a significant contributor to Organon's growth since spin. The 36% ex-FX growth in the first quarter was primarily driven by opportunistic volume associated with the ONTRUZANT tender in Brazil as well as strong growth in NEXPLANON across the access markets in Mexico. The APJ region was down 7% ex-FX this quarter. We expect it to be a challenging year in Japan as we face some national pricing revisions lack favorability from last year when some competitors were out of stock and work through the LOEs of ATOZET and ROSUZET. China was down 5% ex-FX in the quarter. But for the full year 2024, we expect China to grow particularly as we lap the economy-related challenges in China as we saw in the back half of last year.

自旋轉以來，LAMERA 地區一直是 Organon 成長的重要貢獻者。第一季 36% 的外匯成長主要得益於巴西 ONTRUZANT 招標相關的機會交易量以及墨西哥接入市場 NEXPLANON 的強勁成長。亞太及日本地區本季扣除外匯因素後下跌 7%。我們預計今年在日本將是充滿挑戰的一年，因為我們面臨一些國家定價修訂，缺乏去年的優惠，當時一些競爭對手缺貨，並透過 ATOZET 和 ROSUZET 的 LOE 進行工作。中國本季扣除外匯因素後下跌 5%。但對於 2024 年全年，我們預計中國將特別成長，因為我們克服了去年下半年看到的中國經濟相關挑戰。

Overall, we are very pleased with the results through the first quarter of the year. Operational execution is progressing very nicely. We also have our eye on smart deals that fit within our desired financial profile while moving us forward as a company. And finally, there is potential value yet to be unlocked in our clinical portfolio. In life cycle management, in addition to the NEXPLANON 5-year study and the 2 biosimilar assets with Shanghai Henlius that I spoke about earlier, we're making progress in the development of Mercilon for Primary Dysmenorrhea in Japan.

總體而言，我們對今年第一季的業績感到非常滿意。營運執行進展非常順利。我們也專注於符合我們所需財務狀況的明智交易，同時推動我們作為一家公司向前發展。最後，我們的臨床產品組合還有尚未釋放的潛在價值。在生命週期管理方面，除了我之前提到的NEXPLANON 5年研究以及與上海復宏漢霖的2個生物類似藥資產外，我們在日本針對原發性經痛的Mercilon開發也取得了進展。

On the innovative side, both assets we acquired through Forendo are progressing well, and our OG-6219 study investigating a novel approach for treating endometriosis is progressing towards a Phase II readout next year. We're also awaiting first in human dosing for our [OG 719] program targeting the symptoms related to PCOS later this year, for which there is no current treatment.

在創新方面，我們透過 Forendo 獲得的兩項資產進展順利，我們的 OG-6219 研究調查了一種治療子宮內膜異位症的新方法，正朝著明年的 I​​ 期結果邁進。我們也正在等待今年稍後針對 PCOS 相關症狀的 [OG 719] 計畫的首次人體給藥，目前尚無治療方法。

Additionally, we are anticipating preclinical data related to our collaboration with Cirqle, which is a novel method for nonhormonal contraception. It's great to see progress not only happening on the commercial execution side of things, but also in positioning Organon for future growth through our innovative therapies. Now let's turn the call over to Matt, who will go into our financial results in more detail.

此外，我們正在期待與 Cirqle 合作相關的臨床前數據，Cirqle 是一種非荷爾蒙避孕的新方法。很高興看到不僅在商業執行方面取得了進展，而且還透過我們的創新療法為 Organon 的未來成長奠定了基礎。現在讓我們把電話轉給馬特，他將更詳細地介紹我們的財務表現。

Thank you, Kevin. Beginning on Slide 7. Here, we bridge revenue for the first quarter year-over-year. In February for modeling purposes, we suggested that you could consider evenly spreading revenue over the year. which would mean every quarter would be slightly under $1.6 billion in revenue, if you're working from the midpoint of our guidance range. We did a little better than that in the first quarter of 2024 driven by stronger volume especially from NEXPLANON and biosimilars, followed by recovery in injectable steroids namely DIPROSPAN, as well as continued growth from JADA.

謝謝你，凱文。從幻燈片 7 開始。出於建模目的，我們在二月建議您可以考慮在一年中平均分配收入。如果您按照我們的指導範圍的中點進行工作，這意味著每個季度的收入將略低於 16 億美元。我們的表現比 2024 年第一季要好一些，主要是由於銷量增加，尤其是 NEXPLANON 和生物仿製藥的銷量增加，隨後注射類固醇（即迪普羅斯潘）的複蘇，以及 JADA 的持續增長。

Outside of FX, the other revenue drivers were fairly neutral in the quarter. Taken in totality, these other drivers finished Q1 ahead of our expectations, which drove the margin favorability we saw in the quarter. We'll discuss margins in more detail shortly. LOE was about $5 million of impact in the first quarter, which reflects the LOE of ATOZET in Japan. The impact of VBP in China was also about $5 million in the first quarter and reflects lingering effects of the July 2023 implementation of round Round 8 that included REMERON and HYZAAR. There was negligible impact from price in the first quarter. The benefits of our NEXPLANON pricing strategy in the U.S. muted expected pricing pressure in other parts of our business, particularly in biosimilars and to a lesser degree, fertility.

除外匯外，本季其他收入驅動因素相當中性。總的來說，這些其他驅動因素在第一季的表現超出了我們的預期，這推動了我們在本季看到的利潤率好感度。我們很快就會更詳細地討論利潤率。第一季的 LOE 影響約為 500 萬美元，這反映了 ATOZET 在日本的 LOE。第一季 VBP 對中國的影響也約為 500 萬美元，反映了 2023 年 7 月實施的第 8 輪融資的揮之不去的影響，其中包括 REMERON 和 HYZAAR。第一季價格的影響可以忽略不計。我們在美國的 NEXPLANON 定價策略的好處是減輕了我們其他業務領域的預期定價壓力，特別是生物相似藥以及較小程度的生育力領域。

In Supply Other, we captured the lower-margin contract manufacturing arrangements that we had with Merck and have been declining since the spin-off as expected. And lastly, Foreign exchange translation had an approximate $30 million impact or 2 percentage point headwind to revenue, and that's a function of more than 75% of our business being generated outside the U.S. Now let's turn to performance by franchise. As has been our convention, I will target my comments over the next 3 slides to those areas most relevant to your modeling as we think about where we ended the quarter and what the near-term future may hold.

在供應其他方面，我們抓住了與默克公司簽訂的利潤率較低的合約製造安排，並且自分拆以來一直在下降，正如預期的那樣。最後，外匯折算對收入產生了約3000 萬美元的影響，即收入的2 個百分點的阻力，這是因為我們75% 以上的業務是在美國境外產生的。 。按照我們的慣例，我將在接下來的 3 張投影片中針對與您的建模最相關的領域發表評論，同時我們會思考本季的結束情況以及近期的未來可能會發生什麼。

Let's start with women's health on Slide 8. As Kevin mentioned, we expect robust growth for NEXPLANON in the full year. With such strong growth in the first quarter and the benefit of our annual price increase in the U.S., which we took in January. NEXPLANON could achieve double-digit growth this year on a constant currency basis. For fertility, growth will be skewed towards the second half of the year. In the first half, we'll be absorbing the two Q4 2023 issues that Kevin referenced. First, the buy-in that resulted from exiting a temporary spinoff-related commercial arrangement in the U.S. and second, initial supply chain stocking related to the large contract initiation, which is also in the U.S.

讓我們從幻燈片 8 上的女性健康開始。憑藉第一季如此強勁的成長以及我們一月份在美國的年度漲價所帶來的好處。以固定匯率計算，NEXPLANON 今年可能實現兩位數的成長。就生育率而言，成長將偏向下半年。在上半部分，我們將討論 Kevin 提到的 2023 年第四季的兩個問題。首先，是由於退出美國與分拆相關的臨時商業安排而產生的買入；其次，是與同樣在美國啟動的大型合約相關的初始供應鏈庫存。

In the second half of the year, we will have the benefit of lapping what was a difficult fertility environment in China last year plus, we expect volume growth from the provincial expansion of reimbursement and new launches in other markets, as Kevin referenced. Turning to biosimilars on Slide 9. With ONTRUZANT, we have had competitive success as a key supplier of a biosimilar of HERCEPTIN in Brazil. And in the quarter, we had the benefit of incremental upside coming from additional volume through that tender.

正如凱文所提到的，今年下半年，我們將受益於克服去年中國困難的生育環境，此外，我們預計報銷的省級擴張和其他市場的新推出將帶來銷售成長。轉向幻燈片 9 上的生物仿製藥。在本季度，我們透過招標獲得了額外的銷量，從而獲得了增量成長的好處。

I would note that ONTRUZANT growth would have been down this quarter, if not for the incremental upside we had from these additional volumes in Brazil. In fact, on a global basis, we expect ONTRUZANT will be declining this year due to competition in other markets. And on U.S. HADLIMA, we had a strong first quarter, but given that this market has been difficult to predict and continues to evolve, we'll only say that it is our objective to grow that product sequentially each quarter this year.

我要指出的是，如果不是我們從巴西的這些額外銷售中獲得的增量成長，本季 ONTRUZANT 的成長將會下降。事實上，在全球範圍內，由於其他市場的競爭，我們預計 ONTRUZANT 今年將會下降。在美國 HADLIMA 上，我們第一季表現強勁，但考慮到這個市場很難預測並且仍在不斷發展，我們只能說我們的目標是今年每季依次成長該產品。

Turning to Slide 10. Let's talk about pushes and pulls on established brands for the full year 2024. We'll see VBP impacts pick up later in the year, driven by FOSAMAX's inclusion in round 10 expected late in the third quarter. ATOZET will go through LOE in the EU in September of this year, and that product has been doing very well for us in that market. We expect those headwinds to be offset by continued volume growth. For example, contribution from the new migraine assets in Emgality and REYVOW. We expect injectable steroids to continue to recover and you already see that here with 19% ex-FX growth in the Non-opioid Pain and Bone & Derm portfolio.

轉向幻燈片 10。 ATOZET將於今年9月在歐盟通過LOE，該產品在該市場上對我們來說表現非常好。我們預計這些不利因素將被銷售的持續成長所抵消。例如，Emgality 和 REYVOW 的新偏頭痛資產的貢獻。我們預期注射類固醇將持續復甦，您已經看到非鴉片類疼痛和骨與真皮產品組合的除外匯外成長 19%。

These factors should result in about level performance for the established brands portfolio in 2024 FX change. Now let's turn to Slide 11, where we show key non-GAAP P&L line items and metrics for first 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. For gross profit, we are excluding from cost of goods sold, purchase accounting amortization and onetime items related to the spin-off, which can be seen in our appendix slides.

這些因素應該會導致成熟品牌組合在 2024 年匯率變動中表現大致水準。現在讓我們轉向投影片 11，其中我們展示了第一季業績的關鍵非 GAAP 損益項目和指標。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 財務數據以及與非 GAAP 財務指標的調整表。對於毛利，我們不包括銷售商品成本、採購會計攤銷和與分拆相關的一次性項目，這可以在我們的附錄幻燈片中看到。

Adjusted gross margin was 62.1% in the first quarter of 2024 compared with 65.2% in the first quarter of 2023. In the first quarter of 2024, the lower adjusted gross margin was primarily related to unfavorable product mix, foreign exchange translation and higher inflation impacts to material and distribution costs. Despite being below last year, gross margin actually came in stronger than we expected in the first quarter, mostly driven by better performance in price across the aggregated portfolio.

2024年第一季調整後毛利率為62.1%，而2023年第一季為65.2%。分銷成本。儘管毛利率低於去年，但第一季的毛利率實際上強於我們的預期，這主要是由於整體投資組合的價格表現較好。

Total non-GAAP operating expense was down 3% in the quarter, excluding IP R&D, reflective of our cost containment efforts. That is especially the case in R&D, where we have reprioritized clinical spending and rationalized headcount to better align with the types of business development programs we've recently completed and plan to pursue in the near term. IP R&D expense was $15 million in the first quarter compared with $8 million in the prior year period. The $15 million of milestone expense in the first quarter was related to development progression of a denosumab biosimilar.

本季非 GAAP 營運費用總額下降了 3%（不包括智慧財產權研發），這反映了我們在成本控制方面所做的努力。在研發領域尤其如此，我們重新調整了臨床支出的優先順序並合理化了員工人數，以更好地適應我們最近完成併計劃在短期內實施的業務開發計劃類型。第一季智慧財產權研發費用為 1,500 萬美元，而去年同期為 800 萬美元。第一季 1500 萬美元的里程碑費用與狄諾塞麥生物相似藥的開發進展有關。

Milestone payments are inherently difficult to forecast, so we will continue to utilize the same convention that we employed this quarter, and that is to include an estimate of IP R&D and milestones to be recorded in the quarter in our earnings date press release, which will be posted as soon as practical after the close of each quarter. Foreign exchange losses were modestly lower $6 million in the first quarter of 2024 compared with $9 million in the prior year period. In both periods, these are foreign exchange losses primarily driven by normal course business activities in countries where it's not feasible to hedge movements in the local currency.

里程碑付款本質上很難預測，因此我們將繼續採用本季度採用的相同慣例，即包括在我們的收益日新聞稿中記錄的本季度知識產權研發和里程碑的估計，這將每季度結束後儘快發布。 2024 年第一季外匯損失小幅減少 600 萬美元，去年同期為 900 萬美元。在這兩個時期，這些外匯損失主要是由無法對沖當地貨幣變動的國家的正常商業活動造成的。

These factors culminated in an adjusted EBITDA margin of 33.2% in the first quarter of 2024 compared with 33.7% in the first quarter of 2023. Non-GAAP adjusted net income was $315 million or $1.22 per diluted share compared with $276 million or $1.08 per diluted share in 2023. Turning to Slide 12. We provide a closer look at our cash flow for the quarter. For the last 2 years, our free cash flow generation has followed the approximate pattern of 30-70. 30% of our free cash flow was generated in the first half of the year and 70% is generated in the back half.

這些因素最終導致2024 年第一季調整後EBITDA 利潤率為33.2%，而2023 年第一季為33.7%。後淨利潤為2.76 億美元，即稀釋後每股收益1.08 美元2023 年的份額。過去 2 年，我們的自由現金流產生量大致遵循 30-70 的模式。我們的自由現金流有30%是在上半年產生的，70%是在下半年產生的。

In 2022, we generated $875 million of free cash flow before onetime charges. In 2023, that figure rose to $940 million. And in 2024, we expect to reach approximately $1 billion of free cash flow before onetime items underpinned by our financial guidance. Like many companies with December fiscal year-end, Q1 free cash flow was impacted by accrual runoff, largely related to the timing of annual incentive payments, and that represented about 1/3 of that working capital consumption number. Typical to the first quarter, we also see seasonal fluctuations in working capital, which drove the remainder of the change.

2022 年，我們在扣除一次性費用之前產生了 8.75 億美元的自由現金流。 2023 年，這一數字升至 9.4 億美元。到 2024 年，我們預計在我們的財務指導所支持的一次性項目之前，自由現金流將達到約 10 億美元。與許多 12 月財年結束的公司一樣，第一季自由現金流受到應計徑流的影響，這在很大程度上與年度激勵支付的時間有關，約佔營運資本消耗量的 1/3。與第一季一樣，我們也看到營運資本的季節性波動，這推動了其餘的變化。

For onetime cash costs related to the spin-off, in February, when we gave full year 2024 guidance, we said to expect about a 40% reduction from 2023, which would put us in the $200 million ballpark. The $68 million you see here is consistent with that expectation. Of note, we have completed the implementation of our global ERP system as of April, which was the main driver of onetime costs up until this point. Next year, we would expect even lower onetime spin-related costs and beyond 2025 and we expect onetime spin-related costs to be de minimis.

對於與分拆相關的一次性現金成本，2 月份，當我們給出 2024 年全年指引時，我們表示預計比 2023 年減少 40% 左右，這將使我們的預算達到 2 億美元。您在這裡看到的 6800 萬美元與這一預期相符。值得注意的是，截至 4 月份，我們已經完成了全球 ERP 系統的實施，這是迄今為止一次性成本的主要驅動因素。明年，我們預計一次性旋轉相關成本會更低，並且到 2025 年之後，一次性旋轉相關成本將降至最低水準。

In the $36 million of other onetime costs, here, we capture headcount restructuring initiatives and the transition of our manufacturing network related to the spin-off. These costs are distinct from the spin-related standup costs and that they're associated with actions, which will ultimately drive cost efficiencies. Some of which we realized in Q1 and which are already incorporated into our earnings guidance for 2024. Moving to Slide 13 now on debt and leverage. When we provided guidance in February, we were bracing ourselves for leverage to tick higher in the first half of the year before coming down in the second half, ending the year better than 2023 with a view to ending the year below 4x.

在 3,600 萬美元的其他一次性成本中，我們記錄了員工重組計劃以及與分拆相關的製造網絡的轉型。這些成本與旋轉相關的站立成本不同，它們與行動相關，最終將提高成本效率。我們在第一季實現了其中一些目標，並已納入我們的 2024 年獲利指引中。當我們在 2 月提供指引時，我們準備迎接槓桿率在上半年走高，然後在下半年下降，以優於 2023 年的方式結束這一年，以期在年底時低於 4 倍。

With stronger-than-expected EBITDA performance in Q1, our net leverage ratio has remained level with 2023 year-end and is holding at 4.1x. This solid result gives us greater confidence in our February commentary around lowering our net leverage ratio during the year. Now turning to 2024 guidance on Slide 14, where we highlight the items driving our 2024 revenue guidance range of $6.2 billion to $6.5 billion. Some of the individual drivers have changed, but our top line revenue guidance is remaining unchanged. For LOE, that approximate $70 million to $90 million impact for the full year 2024 incorporates ATOZET, both Japan and in the EU later this year. We also have a provision for DULERA, where we have been expecting a generic since its LOE in 2020.

由於第一季 EBITDA 表現強於預期，我們的淨槓桿比率與 2023 年底持平，維持在 4.1 倍。這一堅實的結果讓我們對 2 月有關年內降低淨槓桿率的評論更有信心。現在轉向幻燈片 14 上的 2024 年指導，其中我們重點介紹了推動 2024 年收入指導範圍為 62 億美元至 65 億美元的項目。一些個別驅動因素發生了變化，但我們的營收指導保持不變。對 LOE 來說，2024 年全年的影響約為 7,000 萬至 9,000 萬美元，其中包括今年稍後在日本和歐盟的 ATOZET。我們也為 DULERA 提供了一項規定，自 2020 年其 LOE 以來我們一直期待其仿製藥。

VBP impact is still expected to be in the range of $30 million to $50 million for 2024. By the end of the year, we expect approximately 85% of the portfolio to have gone through VBP. Though minimal in Q1, we expect the impact from price to be in the $180 million to $220 million range, which is up $25 million at the midpoint from the $150 million to $200 million range we talked about in February. Overall, this represents a bit over a 3 percentage point headwind versus prior year and is more in line with our longer-term expectations of price impact across our entire business, given pricing pressure in Biosimilars and U.S. fertility and the mandatory pricing revisions we expect to see in certain international markets.

預計到 2024 年，VBP 的影響仍將在 3,000 萬至 5,000 萬美元之間。儘管第一季的影響很小，但我們預計價格的影響將在 1.8 億美元至 2.2 億美元範圍內，比我們 2 月討論的 1.5 億美元至 2 億美元範圍的中點增加 2500 萬美元。總體而言，考慮到生物相似藥和美國生育力的定價壓力以及我們預期的強制性定價調整，這與去年相比略高於 3 個百分點，並且更符合我們對整個業務價格影響的長期預期。見於某些國際市場。

And for volume, we are raising our estimate by $75 million at the midpoint to $450 million to $650 million to primarily reflect the upside we saw in Biosimilars in the first quarter. Overall, that almost 9% volume growth we expect over last year will be coming from our growth pillars. NEXPLANON, Fertility and JADA within women's health, Biosimilars and China retail as well as the latest addition of Lilly's Emgality and REYVOW in Europe. And finally, based on current spot rates, we think we could see an increasing headwind from FX, now at 160 to 200 basis points, paired with 80 to 160 basis points that we were forecasting back in February. We've absorbed that impact with an improved view of volume growth. So our constant currency revenue guide effectively went up a bit.

至於銷量，我們將預估中位數提高了 7,500 萬美元，達到 4.5 億至 6.5 億美元，主要反映了我們在第一季看到的生物相似藥的上漲趨勢。總體而言，我們預計去年近 9% 的銷售成長將來自我們的成長支柱。女性健康、生物相似藥和中國零售領域的 NEXPLANON、Fertility 和 JADA，以及歐洲最新推出的禮來 (Lilly) 的 Emgality 和 REYVOW。最後，根據目前的即期匯率，我們認為外匯的阻力可能會加大，目前為 160 至 200 個基點，與我們 2 月預測的 80 至 160 個基點相符。我們透過改善銷量成長的視角來吸收這種影響。因此，我們的固定貨幣收入指南實際上有所上升。

Moving to the other components of guidance on Slide 15. For adjusted gross margin, we are continuing to guide to a range of 61% to 63% for 2024. On OpEx expense, even though we are tracking to the lower end of the ranges for SG&A and R&D expense, if you simply annualize Q1, it's a little too early in the year to be calling those ranges down. For SG&A, we have some expense in the second half related to product launches. The migraine products, HADLIMA, XACIATO and JADA internationally to cite a few examples. And that will be partially offsetting the favorable impact of our restructuring cost containment efforts.

轉向幻燈片15 中指導的其他組成部分。下限，但SG&A 和研發費用，如果您只是將第一季年化，那麼今年下調這些範圍還為時過早。對於SG&A，我們下半年有一些與產品發布相關的費用。國際上的偏頭痛產品HADLIMA、XACIATO和JADA就是其中幾個例子。這將部分抵消我們重組成本控制努力的有利影響。

For R&D, the $400 million to $500 million range still feels good, even inclusive of IP R&D to date, but we'll continue to evaluate this as the year progresses and milestone achievement becomes more clear. Interest, tax and depreciation expense ranges are all unchanged. All things considered Q1 was a solid start to the year. We're heading in the right direction on volume growth, margins and operating expense discipline, and we're tracking to another year of constant currency revenue growth. With that, now let's turn the call over to questions and answers.

對於研發來說，4 億至 5 億美元的範圍仍然感覺不錯，甚至包括迄今為止的智慧財產權研發，但隨著時間的推移和里程碑成就變得更加清晰，我們將繼續評估這一點。利息、稅金和折舊費用範圍均維持不變。從所有方面來看，第一季都是今年的良好開端。我們在銷售成長、利潤率和營運費用紀律方面正朝著正確的方向前進，我們將迎來貨幣收入持續成長的另一年。現在，讓我們將通話轉入問答環節。

(Operator Instructions)

（操作員說明）

Our first question comes from the line of Umer Raffat with Evercore ISI.

我們的第一個問題來自於 Evercore ISI 的 Umer Raffat。

I just wanted to focus on free cash flow for a quick second. it's about $109 million before onetime costs. And I guess the true free cash flow is $6 million for this quarter. So it's roughly flat, roughly neutral. And my question is, I knew the working capital was the biggest drag of about $300 million. But 1Q last year wasn't exactly similar. Wasn't it half that at $160 million. So how do we square those knowing that the ERP costs had actually come down but also knowing that maybe heading into 2025, 2026, you could potentially have NEXPLANON headwinds from a free cash flow perspective as patients switch to a 5-year regimen stead of 3-year regimen.

我只是想快速關註一下自由現金流。不計一次性成本約為 1.09 億美元。我猜本季真正的自由現金流是 600 萬美元。所以它大致平坦，大致上是中性。我的問題是，我知道營運資金是最大的拖累，約 3 億美元。但去年第一季的情況並不完全相同。 1.6 億美元不是只有一半嗎？那麼，我們如何平衡這些人知道ERP 成本實際上已經下降，但也知道也許進入2025 年、2026 年，從自由現金流的角度來看，隨著患者改用5 年方案而不是3 年方案，你可能會遇到NEXPLANON 的逆風。

So we'll take the 2024 free cash flow part of your question for Umer. And in our forecasting, it's the seasonality of working capital that will start to reverse in the latter quarters of the year. And so that really enables us to recover -- to the $1 billion before onetime items that we are forecasting.

因此，我們將回答您向 Umer 提出的問題中的 2024 年自由現金流部分。根據我們的預測，營運資金的季節性將在今年後幾季開始逆轉。因此，這確實使我們能夠恢復到我們預測的一次性項目之前的 10 億美元。

Overall, onetime costs related to the spin-off, which were about $344 million last year. We do see that number coming down about 40%, and that will really all be real. You'll see that really in the back quarters of the year. So, just returning to the seasonality of that cash flow being more 70% driven in the back half really, the first quarter performance, Umer, just gives us confidence that we'll be able to hit the full year number.

總體而言，去年與分拆相關的一次性成本約為 3.44 億美元。我們確實看到這個數字下降了 40% 左右，這確實是真的。你會在今年下半年看到這一點。因此，只要回到下半年現金流量的季節性，實際上，第一季的業績，Umer，就使我們有信心達到全年的目標。

And Umer, on your second question in regards to Nexplanon being a headwind in the 25%, 26% range. We don't expect the 5-year indication likely be instituted until 2026, first of all. And second of all, we see 2 reasons to believe that, that will not be a headwind first. There's always a possibility of taking price, but we haven't -- in terms of additional price in the 5-year indication, we haven't decided on that yet. There's a lot of research required, but that's definitely there on the table. And second, and probably more importantly, there's a large chunk of health care providers and patients who would prefer to actually have the 5-year indication who potentially right now are using other forms of contraception.

Umer，關於你的第二個問題，即 Nexplanon 在 25%、26% 範圍內是一個逆風。首先，我們預期 5 年期指標可能要到 2026 年才會制定。其次，我們有兩個理由相信，首先這不會是個逆風。總有可能定價，但我們還沒有——就 5 年指標的額外價格而言，我們還沒有決定。需要進行大量研究，但這肯定是擺在桌面上的。其次，也許更重要的是，有很大一部分醫療保健提供者和患者希望實際上有 5 年的適應症，但他們現在可能正在使用其他形式的避孕方法。

So it is potentially a net gain for us as opposed to a significant headwind.

因此，這對我們來說可能是淨收益，而不是重大阻力。

Our next question comes from the line of Balaji Prasad with Barclays.

我們的下一個問題來自巴拉吉·普拉薩德 (Balaji Prasad) 與巴克萊銀行 (Barclays) 的對話。

Our next question comes from the line of Terence Flynn with Morgan Stanley.

我們的下一個問題來自特倫斯·弗林與摩根士丹利的對話。

This is Dan on for Terence. Just 2 from us. I guess, first, just on U.S. NEXPLANON to get a little more color just on the underlying volume trends that you saw in the quarter and how you're thinking about the rest of the year. And then on HADLIMA, how you're thinking about maybe initially the opportunity in '25 at this point? And any color on some of your initial PBM contracting conversations.

這是特倫斯的丹。離我們只有 2 個。我想，首先，只是在美國 NEXPLANON 上獲得更多關於您在本季度看到的基本銷售趨勢以及您對今年剩餘時間的看法。然後關於 HADLIMA，您現在如何考慮 25 年的機會？以及您最初的 PBM 合約對話中的任何顏色。

Yes. Thanks for the question, Dan. It's Kevin. So I would tell you that the components of NEXPLANON growth this year in the U.S. are strong. We believe that we made the right decision in terms of moving price to Q1 within the queue, within the quarter, so ultimately, any kind of -- any type of buy-in and buyout scenario will happen in that given quarter. Also, demand is starting to really move nicely, both in the 340B channel as well as the commercial side of the things. So we feel really good and that solid. There's going to be a very solid year.

是的。謝謝你的提問，丹。是凱文。所以我想告訴你，NEXPLANON 今年在美國的成長勢頭強勁。我們相信，我們在季度內將價格轉移到隊列中的第一季方面做出了正確的決定，因此最終，任何類型的買入和買斷情況都將在該特定季度發生。此外，無論是 340B 通路或商業方面，需求都開始真正良好發展。所以我們感覺真的很好而且很紮實。這將會是非常充實的一年。

Overall, I do believe it will be a double-digit growth year for NEXPLANON globally and driven by the U.S. performance. And there's just good signals coming out of a number of things that we've done on the ground in order to drive demand in NEXPLANON in the U.S. And secondly, in regards to HADLIMA, I would tell you that HADLIMA is also progressing very well. It's I keep -- I've said for -- it feels like forever now, but for the last few years that it's going to be a slow moving market formation period of time.

總體而言，我確實相信，在美國業績的推動下，NEXPLANON 在全球範圍內將實現兩位數成長。為了推動 NEXPLANON 在美國的需求，我們在實地所做的許多事情都發出了良好的信號。我一直這麼認為——我已經說過了——現在感覺就像永遠一樣，但在過去的幾年裡，這將是一個緩慢發展的市場形成時期。

Right now, you see, for example, more and more PBMs starting to move over to essentially prefer Biosimilars to HADLIMA. We want, of course, exclusive contract with the VA. And so there's going to be more of the market formation as you start to look at 2024 and 2025. And I think as you go through 2025 to 2026, you'll start to see much more erosion of HUMIRA. And as I've always said, as long as you're in the top 2 or 3, you will benefit from that opening of the market.

例如，現在您會看到，越來越多的 PBM 開始轉向本質上更喜歡生物相似藥而不是 HADLIMA。當然，我們希望與退伍軍人管理局簽訂獨家合約。因此，當你開始展望 2024 年和 2025 年時，將會有更多的市場形成。正如我一直說的，只要你進入前 2 名或前 3 名，你就會從市場的開放中受益。

And I continue to say that our peak revenues that we've signaled a couple of hundred million in the U.S. is definitely achievable -- definitely achievable. Hopefully, we'll do more than that as time progresses. But we feel very good. It's just the time continuum of being able to kind of push forward and do what we want to do on our strategy for HADLIMA, and I feel very confident about the product for the coming years.

我繼續說，我們在美國表示的幾億美元的峰值收入絕對是可以實現的——絕對可以實現。希望隨著時間的推移，我們能做得更多。但我們感覺很好。這只是能夠推動 HADLIMA 策略並做我們想做的事情的時間連續體，我對未來幾年的產品非常有信心。

Our next question comes from the line of Chris Shibutani with Goldman Sachs.

我們的下一個問題來自高盛的 Chris Shibutani。

Two questions. Perhaps, if we think about the operating margin progression beyond 2024 based upon the progress that you're making so far? Can you give us a sense for your confidence of potential sources for where and the scope of how that could improve? Secondly, on business development, maybe update us on where you are in terms of seeing opportunities -- in particular, the opportunity that you had with Emgality was quite attractive. Are there more such opportunities do you favor certain segments of the business or geographies?

兩個問題。也許，如果我們根據您迄今為止的進展來考慮 2024 年之後的營業利潤率進展？您能否告訴我們您對潛在來源的信心，以及如何改善的範圍？其次，關於業務發展，也許可以向我們介紹一下您在看到機會方面的情況——特別是您在 Emgality 獲得的機會非常有吸引力。您是否青睞某些業務部門或地區，還有更多這樣的機會嗎？

So I'll start, Chris, on the operating margin part of this. So as we look out into the future, we see margin accretion coming in a few areas. And that will be offsetting, we believe, sort of the constant issues that we face with price in our markets, which are highly competitive, as you know.

克里斯，我將從營業利潤率部分開始。因此，當我們展望未來時，我們看到一些領域的利潤率將會增加。我們相信，這將抵消我們在競爭激烈的市場中持續面臨的價格問題。

On the upside, we will -- we believe that our product mix over time will be mixing towards higher-margin products as things come out of the pipeline and then become commercial. We see productivity efforts and overall cost of goods sold improvement efforts coming from the network rationalization work that we'll be doing as we transition away from Merck services. And finally, we believe that we'll be able to generate operating leverage off of our fixed costs which as you know, we're in the process of realigning this year, and you saw some of the benefits of that in the first quarter itself.

從好的方面來說，我們相信，隨著時間的推移，隨著產品的開發，然後商業化，我們的產品組合將轉向利潤率更高的產品。我們看到生產力的提高和整體銷售成本的改善來自網路合理化工作，當我們從默克服務過渡時，我們將進行這些工作。最後，我們相信我們將能夠從固定成本中產生營運槓桿，正如你所知，我們今年正在進行重新調整，你在第一季就看到了其中的一些好處。

So those are the margin up areas that we're really working hard to pursue and once again, as we referenced in some of the prepared comments that we believe will help us more than offset sort of that constant drumbeat of price that we see around our aggregated network.

因此，這些是我們真正努力追求的利潤率上升領域，正如我們在一些準備好的評論中提到的那樣，我們相信這些評論將幫助我們抵消我們在我們周圍看到的持續不斷的價格上漲。網路。

Chris, in regards to your question around business development Yes, I mean there's going to be more and more of those type of deals that you saw with Lilly deal with REYVOW and Emgality. Our deals that we do is essentially focused on opening the aperture, as I've mentioned before, of women's health. In that case, it was migrane, which essentially 2/3 of patients who suffer from migraine are -- happen to be women. So there are opportunities. They're coming fast and furious over our desk in terms of regional specific, country specific, like, for example, China for China, we have opportunities. We do see China as being a growth country for us in the future in a number of different areas, including women's health, of course.

克里斯，關於您關於業務發展的問題是的，我的意思是您看到禮來公司與 REYVOW 和 Emgality 進行的此類交易將會越來越多。正如我之前提到的，我們所做的交易本質上是為了打開女性健康的大門。在這種情況下，就是偏頭痛，基本上 2/3 的偏頭痛患者恰好是女性。所以有機會。他們在我們的辦公桌上快速而激烈地針對特定區域、特定國家，例如中國對中國，我們有機會。我們確實認為中國未來在許多不同領域將成為我們的成長國家，當然包括婦女健康。

So we'll continue to do that. We'll be very disciplined in the sense that we'll be picking out on those opportunities that clearly fit into our capacity and so that we don't really have to dedicate much operating expense to expanding that portfolio that we bring in. And essentially, it's just accretive pretty soon. And so we'll be doing more of those, and we'll always have our eye towards more of the larger deals as well that move the needle.

所以我們將繼續這樣做。我們將非常自律，因為我們將挑選那些明顯適合我們能力的機會，這樣我們就不必投入太多運營費用來擴大我們引入的投資組合。因此，我們將做更多這樣的事情，我們將始終關注更多具有重大意義的大型交易。

And they are more infrequent as you would expect, but we're definitely looking there. And -- but this year, it's really all about focusing on our financial execution, on making sure that we deliver the numbers and even better, hopefully in the future in this year and working on our leverage and all those nice things that we need to do in order to be able to have more flexibility in the future to do more transformative things, and I think just stay tuned.

正如您所期望的那樣，它們並不常見，但我們肯定會在那裡尋找。而且 - 但今年，真正的重點是我們的財務執行，確保我們交付數字，甚至更好，希望在今年的未來，並致力於我們的槓桿作用以及我們需要的所有這些美好的事情這樣做是為了將來能夠有更大的彈性去做更多變革性的事情，我想請繼續關注。

Helpful update on your perspective.

對您的觀點有幫助的更新。

Our next question comes from the line of Navann Ty with BNP Paribas.

我們的下一個問題來自法國巴黎銀行的 Navann Ty。

It's Jane-Marie for Navann. Can you comment more on what your expectations are for the HUMIRA biosimilar market for this year and the next considering the rise in HUMIRA [assets] and Rx after CVS Caremark effectively remove HUMIRA from its major formulary.

這是納文的珍瑪麗。考慮到 CVS Caremark 有效地將 HUMIRA 從其主要處方中刪除後 HUMIRA [資產] 和 Rx 的增長，您能否進一步評論一下您對今年和明年 HUMIRA 生物仿製藥市場的預期。

Yes, Jane. Sure, I can address that. So I do think it's what I've been essentially predicting for the last couple of years that it's going to be a slow, steady beat -- drumbeat of wins that you see across the channels, whether it's in the PBM world, and you've just mentioned 1 large PBM CVS deciding to go with a different product and obviously, the HUMIRA in terms of exclusivity which is one of the large PBMs. And then you talk about our strategy, which is really on the low net cost providers like the VA and Blue Cross Blue Shield, Medicare and Medicaid, which is about 40% -- 45% of the lives covered in the U.S. today, there looking more to try to save money quicker.

是的，簡。當然，我可以解決這個問題。所以我確實認為這就是我在過去幾年裡一直在預測的，這將是一個緩慢、穩定的節拍——你在各個渠道中看到的勝利的鼓聲，無論是在 PBM 世界，還是你”我們剛剛提到1 個大型PBM CVS 決定使用不同的產品，顯然，就排他性而言，HUMIRA 是大型PBM 之一。然後你談論我們的策略，這實際上是針對低淨成本提供者，如 VA 和 Blue Cross Blue Shield、Medicare 和 Medicaid，涵蓋了當今美國約 40% 到 45% 的人。省錢。

And look, at the end of the day, more like -- something like about 25% to 30% of patients in the commercial plans today are still paying $1,000 or more per month out of pocket for the use of something like HUMIRA. And I think that is something that we're working to try to bring more savings to not only patients but the system so that there's more headroom for best than other innovative things that need to be done. So I do think that the market will open up slowly. It was very slow in '24, I think it will be more in '25 than I think it really will open up in '26 and beyond.

看看，歸根結底，今天商業計劃中大約 25% 到 30% 的患者仍然每月自掏腰包支付 1,000 美元或更多，以使用 HUMIRA 等藥物。我認為我們正在努力不僅為患者而且為系統帶來更多節省，以便比其他需要做的創新事情有更多的空間。所以我確實認為市場會慢慢開放。 24 年的速度非常慢，我認為 25 年的速度會比 26 年及以後的速度還要快。

Our next question comes from the line of Jason Gerberry with the Bank of America.

我們的下一個問題來自美國銀行的傑森·格伯里（Jason Gerberry）。

Just a follow-up on some of HUMIRA. so it looks like Sandoz and Teva have had some success of these private label type deals with large insurer groups. I think Optum is still up for grabs, like is there -- do you see that as a strategy of interest to you? Because I know that at least with the exclusive to Cigna. And then another question just on next on NEXPLANON OUS, your 10-K, you talked about next year majority of countries where NEXPLANON is commercialized out by ex U.S., is this going to expire. So how do you think about that erosion profile with the loss of exclusivity in bulk of your OUS geography.

只是一些 HUMIRA 的後續行動。因此，山德士和梯瓦似乎在與大型保險公司集團的這些自有品牌類型交易中取得了一些成功。我認為 Optum 仍然有待爭奪，就像那裡一樣——您認為這是您感興趣的策略嗎？因為我知道至少 Cigna 是獨家的。接下來關於 NEXPLANON OUS 的另一個問題，你的 10-K，你談到明年 NEXPLANON 在美國以外的大多數國家進行商業化，這是否會到期。那麼，您如何看待在您的 OUS 地理區域中隨著排他性喪失而受到的侵蝕情況。

Is that sort of typical OUS kind of down 30% or not a typical U.S. cliff type dynamic? Or is it better than that? Just curious how you think about the NEXPLANON OUS in '25?

這是典型的 OUS 下跌 30% 還是不是典型的美國懸崖式動態？或比那更好？只是好奇你如何看待 25 年的 NEXPLANON OUS？

Thanks, Jason. Let me take the first question, which is really around what's happening with the HUMIRA biosimilar kind of event or HUMIRA LOE event. Yes, I mean you said it right in the sense that Sandoz was able to acquire the CVS business and then Teva has announced something recently. And of course, Optum, we've got more than 50% access already in the Optum business as we speak today. And I do think that our strategy is resonating with our providers, which is, again, I'll reinforce. We do have, obviously, penetration into the Optum world in regards to a large PBM, but we also have really good pickup state-by-state level, whether you're talking about the VAs at various levels that we're talking about Blue Cross Blue Shield in various states, certain systems.

謝謝，傑森。讓我回答第一個問題，這個問題實際上與 HUMIRA 生物相似藥類型事件或 HUMIRA LOE 事件有關。是的，我的意思是，你說得對，因為 Sandoz 能夠收購 CVS 業務，然後 Teva 最近宣布了一些事情。當然，Optum，正如我們今天所說，我們已經在 Optum 業務中獲得了超過 50% 的訪問權。我確實認為我們的策略與我們的提供者產生了共鳴，我將再次強調這一點。顯然，我們確實在大型 PBM 方面滲透到 Optum 世界，但我們也有很好的州級接聽服務，無論您是在談論各個級別的 VA，還是在談論 Blue在各州、某些系統中交叉藍盾。

And I think those are probably more resilient, more sticky business over the long term is that if you look at it as more kind of diversified the more diversified you are in the biosimilar business, the more you can retain share as it gets more competitive over time. And I still do hold the fact that I think in '25 -- '24 as the year progresses, you'll see better overall penetration into that world. But '25 will definitely open up for us in terms of what we expect to do with HADLIMA.

我認為，從長遠來看，這些業務可能更具彈性、更具黏性，如果你將其視為更加多元化，那麼你在生物相似藥業務中的多元化程度越高，你就越能保留份額，因為它變得更具競爭力。我仍然堅持這樣一個事實，即我認為隨著時間的推移，在 25-24 年，你會看到更好的整體滲透到這個世界。但 25 年肯定會為我們帶來對 HADLIMA 的期望。

Turning to your question about NEXPLANON. I don't foresee any market erosion for the ex-U.S. business. Look, 70% of our business is in the U.S. That's where everybody is going to be looking forward to try to penetrate first. And I think after that, you would get into the much, let's just say, less attractive pricing environment in ex-U.S., whether it's the access markets in the emerging markets or whether it's in Europe, I think that it's just too fragmented and too difficult to penetrate, unless you've got essentially the breadth of being able to get into the U.S. And I don't think, as I've mentioned earlier in my prepared remarks, I clearly think there's a lot of fact out there.

回到你關於 NEXPLANON 的問題。我預計美國以外的市場不會受到任何侵蝕。商業。看，我們 70% 的業務在美國。我認為在那之後，你會進入美國以外地區吸引力較低的定價環境，無論是新興市場的准入市場還是歐洲，我認為它太分散了，而且太分散了。上有能力進入美國。

This is not just suppositions, a lot of fact that would lead one to believe that this is a 2030 event. Our applicator alone globally has patent protection until 2030, and somebody would have to develop their own applicator, which in itself is not as easy as you may think because you've got to do studies around safety, around efficacy of the applicator device alone before you can actually show anything else in regards to the [rod] itself. So I think this is a 2030 event globally and beyond.

這不僅僅是假設，還有很多事實讓人們相信這是 2030 年的事件。我們的塗抹器在全球範圍內享有專利保護，直到 2030 年，有人必須開發自己的塗抹器，這本身並不像您想像的那麼容易，因為您必須先圍繞塗抹器設備的安全性和功效進行研究實際上，您可以展示與[桿]本身相關的任何其他內容。所以我認為這是 2030 年全球乃至更遠的事件。

Our next question comes from the line of David Amsellem with Piper Sandler.

我們的下一個問題來自大衛·阿姆塞勒姆和派珀·桑德勒的對話。

So 2 questions. One is longer term on EBITDA margins beyond control in spend, do you think there's room for margin expansion based on the top line. Anything in the established brands business that can drive margin expansion over time, anything in terms of the women's health business or just its overall footprint that can drive margin expansion over time. This is more of a beyond '24 question, number one.

所以有2個問題。一是從長期來看，EBITDA 利潤率超出了支出的控制範圍，您認為基於營收的利潤率是否還有擴張的空間。成熟品牌業務中的任何業務都可以隨著時間的推移推動利潤成長，女性健康業務或其整體足跡可以隨著時間的推移推動利潤成長。這更像是一個 24 世紀之後的問題，第一個問題。

And then number 2 is, help us better understand long-term leverage targets, particularly with the 2028 maturities. How are you thinking about that? Looking let's say Teva, they have a leverage target in '27 at 2x. I'm not trying to pin you down on the target necessarily, but some of your peers do talk about that. So where do you get comfortable in terms of a steady-state net debt to EBITDA.

第二點是，幫助我們更了解長期槓桿目標，特別是 2028 年到期的槓桿目標。你覺得怎麼樣？比如說 Teva，他們在 27 年的槓桿目標是 2 倍。我並不是想把你固定在目標上，但你的一些同行確實談論過這一點。那麼，對於 EBITDA 的穩態淨債務而言，您在哪裡感到滿意呢？

Yes. Okay, David. So we'll start with your comment on longer-term margin accretion, basically through revenue mix, I think, is your question. And really where we'll be able to achieve that is in what we have coming out of the pipeline towards the latter part of the decade and what we can acquire in during that time frame. So we -- I think we will continue to see stability amongst the portfolio of products that we have now. So I think really, the improvement in revenue mix comes from the relative mix of the things that are growing faster that are in the portfolio right now, and I'm mainly thinking about NEXPLANON, JADA and then what we bring into business development. In terms of leverage, really, since the spin, we've had the same commentary, the same view that this business can run very effectively at leverage levels underneath 3.5x.

是的。好吧，大衛。因此，我們將從您對長期利潤成長的評論開始，我認為，基本上是透過收入組合，這是您的問題。事實上，我們能夠實現這一目標的地方在於我們在本世紀後半段即將推出的產品以及我們在這段時間內可以獲得的東西。因此，我認為我們將繼續看到我們現有產品組合的穩定性。所以我認為，收入組合的改善實際上來自於目前投資組合中成長更快的事物的相對組合，我主要考慮的是 NEXPLANON、JADA 以及我們在業務開發中引入的內容。實際上，就槓桿而言，自旋轉以來，我們得到了相同的評論和相同的觀點，即該業務可以在低於 3.5 倍的槓桿水平下非常有效地運作。

And how far underneath would be dependent on business conditions at the time or just the overall marketability of the stock in terms of investor comfort with leverage ratio on this business. So we see ourselves getting to underneath 4x by the end of this year and then by 2025, getting to that 3.5x target that we've been referring to. So our view on that really hasn't changed. I think investor sentiment around leverage has changed but really, our view in terms of where this business runs most effectively has not. So we still feel the same, and that's sort of what we're targeting as we think about the capital structure going forward.

低於多少將取決於當時的業務狀況，或只是股票的整體適銷性，即投資者對該業務槓桿率的舒適程度。因此，我們預計到今年年底我們將達到 4 倍以下，然後到 2025 年，達到我們一直提到的 3.5 倍目標。所以我們對此的看法確實沒有改變。我認為投資人對槓桿的看法已經改變，但實際上，我們對這項業務最有效營運的看法並沒有改變。所以我們仍然有同樣的感覺，這就是我們在考慮未來資本結構時的目標。

Our final question comes from the line of Balaji Prasad with Barclays.

我們的最後一個問題來自巴拉吉·普拉薩德 (Balaji Prasad) 與巴克萊銀行 (Barclays) 的對話。

Thank you for taking me back on again. Apologies for missing the earlier call. And again, apologies if this has already been covered, please feel free to refer to the transcripts if so. Refer me to the transcript. A couple of things. Firstly, on the biosimilar market, clearly, the private label moves with Cardiva, Zymo and what we saw with ALVO and Teva recently with [Simlandi] seems to be the 1 which is shaping the market and getting greater market share dynamics. So can you comment on your thoughts or expectations around that. On a related note, can you also remind us of HADLIMA path to interchangeability or is still on track for June approval when would you have to wait till Alvotec's exclusivity ends next year for you to claim interchangeability? One.

謝謝你再次帶我回來。很抱歉錯過了之前的電話。再次，如果已經涵蓋了這一點，我們深表歉意，如果是的話，請隨時參考文字記錄。請我參閱文字記錄。有幾件事。首先，在生物相似藥市場上，很明顯，自有品牌與Cardiva、Zymo 的合作以及我們最近在ALVO 和Teva 與[Simlandi] 上看到的情況似乎是正在塑造市場並獲得更大市場份額動態的第一個。您能否就此發表一下您的想法或期望？與此相關，您能否提醒我們 HADLIMA 實現可互換性的途徑，或者仍有望在 6 月份獲得批准，您何時必須等到 Alvotec 的獨佔權明年結束才能聲明可互換性？一。

Secondly, on the established brands side, now that we see Emgality and REYVOW in contributing. Can you help me understand a bit more on the dynamics here and the expectations for these brands going forward?

其次，在老牌品牌方面，我們看到 Emgality 和 REYVOW 做出了貢獻。您能幫助我更了解這裡的動態以及對這些品牌未來的期望嗎？

Balaji, its good to talk to you. So I would say the first question in regards to biosimilars and HADLIMA, I do think that it's a good signal, by the way, that, for example, the first signal being CVS, essentially going strictly with the Sandoz product. It really is a good signal for the market formation that we keep talking about itself. But remember, the market has split into 2 pieces. It's the PBMs that are about 5-or-so percent of the overall lives covered, and it's all the other low net cost providers, as I've mentioned many times, that represent about 45% of the business.

巴拉吉，很高興與你交談。所以我想說關於生物相似藥和 HADLIMA 的第一個問題，順便說一句，我確實認為這是一個很好的信號，例如，第一個信號是 CVS，本質上嚴格遵守 Sandoz 產品。我們一直在談論市場本身，這對市場形成來說確實是一個很好的訊號。但請記住，市場已分裂為兩部分。 PBM 約佔總生命週期的 5% 左右，而正如我多次提到的，所有其他低淨成本提供者約佔業務的 45%。

And they're really more focused -- lives rather covered. They're more focused on low net cost products, they're not laying the rebate game as well that they're just focusing on lower net costs. So I think it is going to be very dynamic as we think about what's going to happen over this year and next year. And we're continuing to be very competitive, and our strategy is pulling through. We're among the top 1 or 2 Biosimilars currently and TRx and NRx U.S. And we feel very strongly that we'll be in a very solid position as time progresses to continually grab share from the originator and to drive for our peak revenues where we've always signaled that we feel very strong about in terms of the couple of hundred millions in the U.S. In regards to established brands and where we're going with REYVOW and Emgality, look, we've just started right now in terms of promotion in the EU.

他們確實更加專注——生活更加充實。他們更關注低淨成本產品，他們也不玩回扣遊戲，他們只是關注較低的淨成本。所以我認為，當我們思考今年和明年會發生什麼時，這將是非常動態的。我們將繼續保持強大的競爭力，我們的策略正在取得進展。我們目前是排名前1 或2 名的生物仿製藥以及美國TRx 和NRx 之一，我們強烈地感到，隨著時間的推移，我們將處於非常穩固的地位，不斷從原研藥手中奪取份額，並推動我們的峰值收入一直以來，我們都表示，我們對美國的數億消費者信心十足。

Some countries still have yet to come in, in terms of that. I think that will happen in the coming months. It's a fast-growing segment actually in Europe in terms of the migraine segment. And we are really well positioned because these are 2 products that are well known, recently launched, have a good reputation, and we've got a great team that are really, really excited and very energized about being able to take over and showing what we can do with these 2 products.

就這一點而言，一些國家尚未加入。我認為這將在未來幾個月內發生。就偏頭痛而言，實際上在歐洲這是一個快速成長的細分市場。我們的定位非常有利，因為這兩款產品眾所周知，最近推出，擁有良好的聲譽，而且我們擁有一支優秀的團隊，他們對能夠接管並展示什麼感到非常非常興奮和充滿活力。種產品來做。

And look for more of these type of deals to happen that are accretive that make use of our scale and our global infrastructure, and that really makes sense in terms of fitting into what we're trying to do and generating more cash for us to be able to do more business development and a larger scale over time.

並期待更多此類交易的發生，這些交易是利用我們的規模和全球基礎設施來增值的，這對於適應我們正在嘗試做的事情並為我們創造更多現金而言確實有意義。的推移，能夠進行更多的業務開發和更大的規模。

If I could just have a follow-up to it. I appreciate the detailed explanation. In light of this performance, the outlook, I thought guidance could have raised possibly, how conservative are you with the guidance retaining or reaffirming what you had said earlier?

如果我能跟進一下就好了。我很欣賞詳細的解釋。鑑於這種表現和前景，我認為指引可能會提高，你對保留或重申你之前所說的指引有多保守？

Yes. So we were certainly encouraged by the first quarter performance really across all of our franchises, Balaji. But the thing that we were considering most when thinking about what to do with guidance was really what's going on with foreign exchange.

是的。因此，我們確實對我們所有特許經營權 Balaji 第一季的表現感到鼓舞。但在考慮如何使用指導時，我們考慮最多的事情實際上是外匯方面的情況。

The dollar is persistently strong. When we created our initial guidance in 2024, the euro was somewhere between $1.08 and $1.09 it since come back. And so like we said in the prepared comments, when we look at the nuts and bolts aspects of our top line revenue, we're actually up on constant currency basis. And it's really just the FX dynamic that is causing us to be a little bit reticent about raising guidance this early in the year.

美元持續強勢。當我們在 2024 年制定初步指引時，歐元匯率在 1.08 美元至 1.09 美元之間，此後又回升。正如我們在準備好的評論中所說，當我們查看營收的具體細節時，我們實際上是在固定匯率的基礎上實現成長的。事實上，正是外匯動態導致我們對於在今年年初提高指導意見有點猶豫。

We'll revisit this when we issue Q2 results. But once again, the performance in first quarter gives us a lot of confidence in the initial guidance that we gave, and we're just optimistic as we leg into the second quarter here.

當我們發布第二季業績時，我們將重新審視這一點。但第一季的表現再次讓我們對我們給予的初步指導充滿信心，並且當我們進入第二季度時我們感到樂觀。

That concludes our question-and-answer session. I would now like to turn the call back over to Kevin Ali for closing remarks.

我們的問答環節到此結束。我現在想將電話轉回給凱文·阿里，讓他發表結束語。

I want to thank you. I want to close today's call by essentially repeating what I began today's call with, namely that we came into 2024. Looking at it as a year to focus on execution delivering on our projections, improving our financial positioning and of course, building for our future pipeline. And through Q1, we can definitely say that we're progressing well towards those goals. And I want to thank all of you for a great discussion today, and we look forward to continued engagement.

我想謝謝你。在結束今天的電話會議時，我想基本上重複我在今天電話會議開始時所說的內容，即我們進入了2024 年。財務狀況，當然還有為我們的未來建設的一年管道。透過第一季度，我們可以肯定地說，我們在實現這些目標方面進展順利。我要感謝大家今天的精彩討論，我們期待繼續參與。

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。