Amneal Pharmaceuticals Inc (AMRX) 2024 Q3 法說會逐字稿

Good morning, and welcome to the Amneal Pharmaceuticals third quarter 2024 earnings call. I'll now turn the call over to Amneal's Head of Investor Relations, Tony DiMeo. Please go ahead.

早安，歡迎參加 Amneal Pharmaceuticals 2024 年第三季財報電話會議。現在我將電話轉給 Amneal 的投資者關係主管 Tony DiMeo。請繼續。

Good morning, and thank you for joining Amneal Pharmaceuticals' third quarter 2024 earnings call. Today, we issued a press release reporting Q3 results. The earnings press release and presentation are available at amneal.com. Certain statements made on this call regarding matters that are not historical facts, including, but not limited to, management's outlook or predictions are forward-looking statements that are based solely on information that is now available to us.

早安，感謝您參加 Amneal Pharmaceuticals 2024 年第三季財報電話會議。今天，我們發布了一份新聞稿報告第三季業績。收益新聞稿和簡報可在 amneal.com 上找到。本次電話會議中涉及非歷史事實的某些陳述，包括但不限於管理階層的展望或預測，都是基於我們現有資訊的前瞻性陳述。

Please see the section entitled Cautionary Statements on Forward-Looking Statements for factors that may impact future performance. We also discuss non-GAAP measures. Information on use of these measures and reconciliations to GAAP are in the earnings release and presentation.

請參閱「前瞻性陳述的警告聲明」部分，以了解可能影響未來績效的因素。我們也討論了非公認會計準則指標。有關這些指標的使用以及與 GAAP 的對帳資訊均包含在收益報告和介紹中。

On the call today are Chirag and Chintu Patel, co-Founders and co-CEOs, Tasos Konidaris, CFO; our commercial leaders, Andy Boyer for Generics; Joe Renda Specialty; and Jason Daly, Chief Legal Officer. I will now hand the call over to Chirag.

今天參加電話會議的有共同創辦人兼聯合執行長 Chirag 和 Chintu Patel，以及財務長 Tasos Konidaris；我們的商業領袖，Generics 的 Andy Boyer；喬·倫達 (Joe Renda) 專業；以及首席法律官Jason Daly。我現在將電話交給 Chirag。

Thank you, Tony. Good morning to everyone. We're excited to talk about our strong Q3 results. Our entry into obesity and metabolic disease space with Metsera collaboration and our recent launch of CREXONT for Parkinson's disease. Q3 was an excellent quarter as we continue to drive sustainable growth and took actions to solidify our long-term growth profile.

謝謝你，托尼。大家早安。我們很高興談論我們強勁的第三季業績。我們與 Metsera 合作進軍肥胖症和代謝疾病領域，並最近推出了用於治療帕金森氏症的 CREXONT。第三季表現優異，我們繼續推動永續成長，並採取行動鞏固我們的長期成長前景。

First, I'll discuss our recently announced collaboration and entry into the global obesity space. The GLP-1 market is prime for innovation and expanding access to these novel class of therapies. And with Metsera, we are poised to deliver new, high-quality medicines at scale. Metsera is a clinical stage biotech company purpose built for advancing the next generation of weight loss medicines. They have rich proprietary library of peptides with a pipeline of innovative injectable and oral therapies.

首先，我將討論我們最近宣布的合作以及進入全球肥胖領域的舉措。GLP-1 市場是創新和擴大此類新型療法應用管道的主要市場。借助 Metsera，我們準備大規模提供新的高品質藥品。Metsera 是一家臨床階段生物科技公司，致力於推動下一代減肥藥物的研發。他們擁有豐富的專有勝肽庫以及一系列創新的注射和口服療法。

Amneal's high-quality manufacturing and operational expertise is complementary to Metsera's drug discovery capabilities. This collaboration is an important milestone for Amneal and underscores the strength of our capabilities and our reputation as an industry leader. Amneal is Metsera's preferred global supplier in the United States, Europe and other markets and has been granted a license to commercialize Metsera products in select emerging markets, including India, and certain countries in Southeast Asia, Africa and the Middle East. We will leverage our existing infrastructure and build two new world-class manufacturing facilities in India to support the initiative.

Amneal 的高品質製造和營運專業知識與 Metsera 的藥物研發能力相得益彰。此次合作對 Amneal 來說是一個重要的里程碑，彰顯了我們的實力和身為產業領導者的聲譽。Amneal 是 Metsera 在美國、歐洲和其他市場的首選全球供應商，並已獲得在印度以及東南亞、非洲和中東的某些國家等特定新興市場銷售 Metsera 產品的許可。我們將利用現有的基礎設施，在印度建造兩個新的世界級製造工廠來支持該計劃。

Importantly, this collaboration creates a new high-growth vector for Amneal with multiple avenues for value creation in a rapidly growing space that is estimated to reach over $100 billion by 2030. It is a logical extension of our strategy, a deep expertise in complex pharmaceutical manufacturing and our track record of delivering high-quality innovation at scale.

重要的是，此次合作為 Amneal 創造了一個新的高成長載體，為在這個快速成長的領域創造價值提供了多種途徑，預計到 2030 年其價值將超過 1000 億美元。這是我們策略的合理延伸，也是我們在複雜藥品製造方面的深厚專業知識以及我們大規模提供高品質創新的記錄的合理延伸。

Second, we are incredibly excited about the recent launch of CREXONT which is an important achievement for the company. This new and innovative treatment advances the standard of care for patients with Parkinson's disease, providing a longer duration of good on time with less frequent dosing. Chintu and I met with key opinion leaders and prescribers at the Movement Disorder Society Congress recently, and there is a tremendous excitement for CREXONT.

其次，我們對最近推出的 CREXONT 感到非常興奮，這對公司來說是一項重要成就。這種新穎的治療方法提高了帕金森氏症患者的護理標準，以更少的服藥頻率提供更長的按時治療時間。Chintu 和我最近在運動障礙協會大會上會見了關鍵意見領袖和處方人員，他們對 CREXONT 感到非常興奮。

As an organization, we have a deep expertise working within Parkinson's space for over 10 years as we had commercialized Rytary. The CREXONT launch is off to a strong start. We are confident in our ability to further expand our specialty segment including the potential to add branded opportunities over time.

作為一個組織，我們在帕金森氏症領域擁有超過 10 年的深厚專業知識，並且已經將 Rytary 商業化。CREXONT 的發表會開局良好。我們有信心進一步擴大我們的專業領域，包括隨著時間的推移增加品牌機會的潛力。

Next, in the affordable medicines business, which is our generic segment, we continue to expand portfolio with new products that are driving continued growth. Year-to-date, revenue growth is 12%. The first growth area is retail, and particularly complex generics. Amneal has been number 1 in the United States complex generic therapy innovation since 2018.

接下來，在平價藥品業務（即我們的仿製藥業務）中，我們將繼續擴大產品組合，推出推動持續成長的新產品。今年迄今，營收成長率為 12%。第一個成長領域是零售，特別是複雜的仿製藥。自 2018 年以來，Amneal 一直在美國複雜仿製藥治療創新領域排名第一。

We have launched, on average, 30 or more new products each year. This has driven tremendous diversification with oral solid generics decreasing from over half of total company's revenue in 2019 to less than a quarter this year. Our affordable medicines business is foundational to Amneal and will continue to drive meaningful value for the company.

我們平均每年推出30種或更多的新產品。這導致了巨大的多樣化，口服固體仿製藥占公司總收入的比重從 2019 年的一半以上下降到今年的不到四分之一。我們的平價藥品業務是 Amneal 的基礎，並將繼續為公司帶來有意義的價值。

The second growth area is injectables. Our portfolio of over 40 products continue to expand with over 10 new launches expected each year. In 2024, we launched our first 505 (b)(2) products, which are differentiated, ready-to-use solution that can improve hospital pharmacy efficiencies by eliminating medication preparation steps.

第二個成長領域是注射劑。我們的產品組合超過 40 種，並且每年都會擴大，預計將有超過 10 種新產品推出。2024 年，我們推出了首款 505 (b)(2) 產品，這是一種差異化、即用型解決方案，可透過消除藥物準備步驟來提高醫院藥房的效率。

Overall, the US injectable market continues to face supply disruptions, which Amneal is addressing head on. Today, Amneal provides 13 injectables currently on the shortage list, and we are proactively working to help alleviate other market shortages. The third growth area in affordable medicines is biosimilars, we have built a strong foundation with our first three commercial similars. Also, we have planted the seeds for long-term growth by in-licensing five more pipeline biosimilars all expected to launch by 2027.

總體而言，美國注射劑市場持續面臨供應中斷的問題，Amneal 正在積極解決這個問題。如今，Amneal 提供 13 種目前處於短缺名單中的注射劑，我們正在積極努力幫助緩解其他市場短缺問題。平價藥物的第三個成長領域是生物相似藥，我們已經透過前三種商業仿製藥建立了堅實的基礎。此外，我們也透過授權另外五種正在研發的生物相似藥，預計這些藥物將於 2027 年上市，為長期成長播下了種子。

In Q3, we took an important step in in-licensing omalizumab biosimilar for a brand name Xolair, to our pipeline, another high-value therapeutic. This product is roughly $4 billion plus on the global market that expands our portfolio beyond oncology to allergy. Overall, biosimilars are the next wave of affordable medicines in the United States as about 60% of upcoming pharmaceuticals LOEs by value are biologics.

在第三季度，我們邁出了重要的一步，將奧馬珠單抗生物仿製藥（品牌名 Xolair）引入我們的產品線，這是另一種高價值治療藥物。該產品在全球市場的銷售額約為 40 多億美元，將我們的產品組合從腫瘤學擴展到了過敏症領域。總體而言，生物相似藥是美國下一波平價藥物，因為以價值計算，約 60% 的即將上市的藥品 LOE 都是生物製劑。

Accordingly, the US biosimilar market is estimated to grow from $4 billion to $5 billion today to $20 billion to $30 billion by 2032 from a manufacturer's net sales perspective. New biosimilars provide enhanced excess affordability and value for patients. We are building a significant biosimilar portfolio and will be vertically integrated over time as we see biosimilars as a key growth vector for Amneal in the long run.

因此，從製造商的淨銷售額角度來看，美國生物相似藥市場規模預計將從目前的 40 億至 50 億美元成長到 2032 年的 200 億至 300 億美元。新型生物相似藥為患者提供了更高的可負擔性和價值。我們正在建立重要的生物相似藥產品組合，並將隨著時間的推移進行垂直整合，因為我們認為生物相似藥是 Amneal 長期成長的關鍵載體。

Next, International expansion is a long-term growth area for us. In India, we are building a customized portfolio of products. In other markets, we are registering select products with our partners to start supplying in Q4. We expect International will be adding $50 million to $100 million revenues by 2027.

其次，國際擴張是我們的長期成長領域。在印度，我們正在建立客製化的產品組合。在其他市場，我們正在與合作夥伴註冊精選產品，以便於第四季開始供貨。我們預計到 2027 年國際收入將增加 5,000 萬至 1 億美元。

Finally, the health care distribution business continues to deliver double-digit growth, driven by all three channels, distribution, government and unit dose. And now we expect over $700 million in healthcare revenue in 2025.

最後，醫療保健分銷業務持續實現兩位數成長，這主要得益於分銷、政府和單位劑量三個管道的推動。我們預計 2025 年醫療保健收入將超過 7 億美元。

Overall, we could not be more excited with how well positioned Amneal to drive continued growth. Today, Amneal has a diversified global pharmaceutical company that provides access to high-quality, affordable and essential medicines for patients, providers and payers. We have purposefully and strategically expanded our business and added new vectors for growth.

總體而言，我們對 Amneal 推動持續成長的良好定位感到非常興奮。如今，Amneal 已成為一家多元化的全球製藥公司，為患者、供應商和付款人提供高品質、價格合理的基本藥物。我們有目的、有策略地擴展了我們的業務並增加了新的成長動力。

I will now pass it to Chintu.

我現在將其傳遞給 Chintu。

Good morning, everyone. Thank you, Chirag, and thank you to the global Amneal family who wakes up every day with energy and passion to make healthy possible. I will discuss our core strengths in operations, innovation and pull you where Amneal continues to thrive then I will share how we will utilize our vast experience and capabilities in the GLP-1 space, which is a new growth vector for Amneal.

大家早安。謝謝你，Chirag，也感謝全球 Amneal 大家庭，他們每天醒來都充滿活力和熱情，致力於讓健康成為可能。我將討論我們在營運、創新方面的核心優勢，並引導您走向 Amneal 持續蓬勃發展的地方，然後我將分享我們如何利用我們在 GLP-1 領域的豐富經驗和能力，這是 Amneal 的一個新的成長方向。

First, in operations, Quality is at the center of everything we do. Our world-class global operations have an industry-leading quality track record, and we had multiple successful inspection at our sites over the last quarter. Across our organization, we are investing in automation, digitization and AI technologies to advance our global infrastructure. We are driving operational excellence, Kaizen cost improvements and skill development programs to enable our next generation of capabilities and growth.

首先，在營運中，品質是我們所做的一切的核心。我們世界一流的全球營運擁有業界領先的品質記錄，並且我們在上個季度多次成功通過了我們的工廠檢查。在我們的整個組織中，我們正在投資自動化、數位化和人工智慧技術，以推進我們的全球基礎設施。我們正在推動卓越營運、Kaizen 成本改進和技能發展計劃，以實現我們下一代的能力和成長。

We see operational excellence, high levels of customer fulfillment and a robust supply chain as the key competitive advantages for us as the recent storms in the US remind us drug shortages, particularly for injectables remains a US supply challenge, and we are working hard to be part of the solution.

我們將卓越的營運、高水準的客戶滿意度和強大的供應鏈視為我們的主要競爭優勢，因為最近美國發生的風暴提醒我們藥品短缺，特別是注射劑短缺仍然是美國供應面臨的挑戰，我們正在努力成為解決方案的一部分。

Second, in innovation, we launched CREXONT in September, which is a remarkable new treatment for Parkinson's disease, which will benefit many patients. We are hearing testimonies from patients that CREXONT is changing their daily lives. Its unique and novel formulation is designed to provide rapid onset of action and extended efficacy to deliver more good on time with less frequent dosing.

第二，在創新方面，我們9月推出了CREXONT，這是一種了不起的帕金森氏症新療法，將使許多患者受益。我們聽到患者的證言，CREXONT 正在改變他們的日常生活。其獨特、新穎的配方旨在提供快速起效和延長療效，從而以更少的用藥頻率按時提供更多益處。

As a leader in the Parkinson's space, we are working to bring this new therapy to patients quickly and are pleased with early adoption. Another specialty R&D program we have been working on, but had not disclosed prior to approval is extended release Pyridostigmine Bromide. This product is once daily pretreatment for protection against soman gas and other chemical agents and was developed in close collaboration with the US government for used by military personnel.

作為帕金森氏症領域的領導者，我們正在努力迅速為患者帶來這種新療法，並對早期採用感到滿意。我們一直在進行的另一項專業研發項目是溴吡斯的明緩釋劑，但在獲得批准之前尚未披露。該產品是每日一次的預處理產品，用於防禦梭曼毒氣和其他化學製劑，是與美國政府密切合作開發的，供軍事人員使用。

Our new drug application was approved in October. Our next specialty R&D program is DHE auto injector for migraine and cluster headache, which can save patients for having to make emergency room visits during these very painful episodes. We are on track for our NDA response in Q4, which would put us in a good position to launch in Q2 of next year once approved.

我們的新藥申請已於十月獲得批准。我們的下一個專業研發項目是用於治療偏頭痛和叢集性頭痛的 DHE 自動注射器，它可以讓患者免於在這些非常痛苦的發作期間去急診室就診。我們正在按計劃在第四季度完成 NDA 回應，這將使我們在獲得批准後能夠在明年第二季度順利推出產品。

Next, I will touch on our complex generic portfolio. With over 20 product launches so far this year, we are on track to launch 30 new launches again in 2024. We expect this cadence of innovation to continue with 79 new products pending approval, 63% of which are non-oral solids and 57 pipeline programs in development, and 93% of recharge non-oral solids. Within our R&D organization, we have enhanced our efficiency and capabilities to develop more complex products on faster time line at lower cost. As a result, we are allocating more investment towards external R&D over time, especially in biosimilars and specialty.

接下來，我將談談我們複雜的通用產品組合。今年迄今已推出 20 多種產品，我們預計在 2024 年再次推出 30 款新產品。我們預計這種創新節奏將持續下去，目前有 79 種新產品等待批准，其中 63% 為非口服固體製劑，57 個正在開發中的管線項目，以及 93% 的補給非口服固體製劑。在我們的研發機構內，我們提高了效率和能力，以便以更低的成本在更短的時間內開發更複雜的產品。因此，我們將隨著時間的推移向外部研發投入更多資金，特別是在生物相似藥和專科藥物領域。

In Injectables, we have launched 11 new products so far this year, including our first 505(b)(2) products primarily for the treatment on non-small cell lung cancer, nausea associated with oncology treatment, and potassium phosphate are ready-to-use IV bags.

在註射劑方面，我們今年迄今已推出了 11 種新產品，包括我們的首批 505(b)(2) 產品，主要用於治療非小細胞肺癌、腫瘤治療相關的噁心以及磷酸鉀即用型靜脈注射袋。

We have developed our 505(b)(2) injectable portfolio based on stakeholder feedback, and we have built curated pipeline of injectable presentations with over 15, 505(b)2 injectables in development. Our other complex injectable R&D programs continue to advance in our pipeline including microspheres, liposomes and drug device combination.

我們根據利害關係人的回饋開發了我們的 505(b)(2) 注射劑產品組合，並且我們已經建立了精選的注射劑產品線，其中有超過 15 種 505(b)2 注射劑正在開發中。我們的其他複雜注射研發計畫也持續推進，包括微球、脂質體和藥物裝置組合。

Next, we see inhalation as a new growth vector ahead for Amneal. We have a series of high-value launches planned over the next several years that will utilize our ready and approved Ireland manufacturing sites. We have inhalation programs across the major device categories, including dry powdered and metadoze inhalers and the Respimat platform. We are excited about our inhalation pipeline with our first inhalation product pending approval soon and many more to come in the years ahead.

接下來，我們將吸入視為 Amneal 未來的新成長方向。我們計劃在未來幾年推出一系列高價值產品，這些產品將利用我們已準備好且已批准的愛爾蘭製造基地。我們擁有涵蓋主要設備類別的吸入計劃，包括乾粉吸入器、metadoze 吸入器和 Respimat 平台。我們對我們的吸入產品線感到非常興奮，我們的第一個吸入產品即將獲得批准，未來幾年還會有更多產品推出。

Next, in biosimilars, we are strategically focused on expanding our portfolio Building on the success of our first three commercial products, we have in-licensed five additional biosimilar pipeline candidates. We are filing our BLAs for two denosumab biosimilars for Prolia and XGEVA in Q4.

其次，在生物相似藥方面，我們策略性地專注於擴大我們的產品組合，在我們前三種商業產品成功的基礎上，我們已獲得另外五種生物相似藥候選藥物的許可。我們將於第四季提交 Prolia 和 XGEVA 兩種地舒單抗生物相似藥的 BLA。

Next, we expect to file the pegfilgrastim onboard injected and prefilled auto-injector products in Q1. After that, we expect to file the BLA for omalizumab a biosimilar for Xolair by the end of 2025. We will add more molecules to our pipeline to expand our biosimilar portfolio and look to be vertically integrated over time. We remain very excited about biosimilars as a key vector of growth as many biologic products face LOE in the coming years.

接下來，我們預計將在第一季提交培非格司亭機上註射和預充自動注射器產品。之後，我們預計在 2025 年底前提交 Xolair 生物相似藥奧馬珠單抗的 BLA。我們將在我們的產品線中添加更多的分子，以擴大我們的生物相似藥產品組合，並隨著時間的推移實現垂直整合。由於未來幾年許多生物製品都面臨 LOE，我們仍然對生物相似藥作為成長的關鍵載體感到非常興奮。

Internationally, we have distribution partners in place for key developed and emerging markets, registering products globally, including in Europe and emerging markets. International expansion remains a key area of focus for us at Amneal as we look to significant growth opportunities ahead.

在國際上，我們在主要已開發市場和新興市場都有分銷合作夥伴，在全球範圍內註冊產品，包括歐洲和新興市場。我們期待未來的巨大成長機會，國際擴張仍然是 Amneal 關注的重點領域。

Let me now turn to our entry into the GLP-1 space. Today, Amneal has existing infrastructure and capabilities for developing peptides and finished product. As part of the Metsera collaboration, we will build two new state-of-the-art GLP-1 manufacturing facilities. One facility will be for producing peptite drug substance and the second for advanced sterile fill finish manufacturing capability of producing high volumes of finished products. Amneal will provide its expertise and infrastructure for formulation development and other CMC activities and also serve as Metsera's preferred global supplier.

現在讓我來談談我們進入 GLP-1 領域。如今，Amneal 已擁有開發勝肽和成品的現有基礎設施和能力。作為 Metsera 合作的一部分，我們將建造兩座新的最先進的 GLP-1 製造工廠。一個工廠將用於生產勝肽類藥物，另一個工廠將用於生產大量成品的先進無菌填充完成製造能力。Amneal 將提供其用於配方開發和其他 CMC 活動的專業知識和基礎設施，並作為 Metsera 的首選全球供應商。

As we look ahead, we plan to utilize our leading innovation and operational capabilities and quality track record in developing and manufacturing complex pharmaceuticals in this new fast growth category. In summary, when Chirag and I returned as co-CEOs in 2019, we laid out a strategy for diversification and growth.

展望未來，我們計劃利用我們領先的創新和營運能力以及品質記錄來開發和製造這個新的快速成長類別的複雜藥品。總而言之，當 Chirag 和我於 2019 年重返聯合執行長職位時，我們制定了多元化和成長策略。

Since then, we have executed on that plan. We are deeply purpose-driven company on a mission to provide access to affordable innovation. Today, Amneal is growing in key areas of medicine, specialty branded, biosimilars, injectables, complex generics and now GLP-1s and extending access through our distribution and international business. As we celebrate our success over these last five years, we are focused on execution and so excited for the next five years.

自那時起，我們就執行該計劃。我們是一家目標明確、致力於提供價格合理的創新產品的公司。如今，Amneal 在醫藥、專業品牌、生物相似藥、注射、複雜仿製藥以及現在的 GLP-1 等關鍵領域不斷發展，並透過我們的分銷和國際業務擴大了銷售管道。當我們慶祝過去五年所取得的成功時，我們專注於執行，並對未來五年充滿期待。

I will now pass it over to Tasos.

現在我將把它交給塔索斯。

Thank you, Chintu, and good morning, everyone. We're very pleased to report another terrific quarter with strong revenue and adjusted EBITDA growth, robust cash generation and continued debt reduction. .

謝謝你，Chintu，大家早安。我們非常高興地報告又一個出色的季度，強勁的收入和調整後的 EBITDA 成長，強勁的現金產生和持續的債務減少。。

I'll first discuss our third quarter and year-to-date results, then move on to cars and capital allocation priorities. In the third quarter, revenues grew 13% to $702 million with continued growth across all our three business segments. Our generics, what we also call our affordable medicines business grew 9% to $427 million. This terrific performance was driven by the strength of new product launches, which in turn help improve shortages and provide exceptional value to our customers, payers and patients.

我將首先討論我們的第三季和年初至今的業績，然後討論汽車和資本配置重點。第三季度，營收成長 13% 至 7.02 億美元，我們三個業務部門均持續成長。我們的仿製藥（也稱為平價藥品）業務成長了 9%，達到 4.27 億美元。這一出色的業績得益於新產品的強勁發布，這反過來有助於改善短缺問題並為我們的客戶、付款人和患者提供卓越的價值。

New products launched in 2023 and 2024 contributed $35 million to Q3 revenue growth and also biosimilars, generated $31 million in revenue. Amneal's continued R&D innovation, superb quality track record and consistency of supplier to competitive advantages, driving sustainable value creation and diversification.

2023 年和 2024 年推出的新產品為第三季的營收成長貢獻了 3,500 萬美元，生物相似藥也創造了 3,100 萬美元的收入。Amneal 持續的研發創新、卓越的品質記錄和供應商的一致性競爭優勢，推動了可持續的價值創造和多樣化。

Let me now move to our Specialty segment, where revenues grew 19% to $116 million, driven by our branded products. Our Parkinson's franchise which now includes CREXONT, Rytary and ONGENTYS delivered $61 million in revenue and contributed $17 million to Q3 revenue growth.

現在讓我談談我們的專業部門，在我們的品牌產品的推動下，該部門的收入成長了 19％，達到 1.16 億美元。我們的帕金森氏症特許經營權現已包括 CREXONT、Rytary 和 ONGENTYS，實現了 6,100 萬美元的收入，並為第三季的收入成長貢獻了 1,700 萬美元。

CREXONT's quarterly revenue was $3 million due to the initial stacking. One month post launch, we are pleased with the early indicators of commercial uptake, inclusive of prescription trends, physician and patient testimony as well as insurance providers interested in making this new therapy available to their patients.

由於最初的堆疊，CREXONT 的季度收入為 300 萬美元。上市一個月後，我們對商業應用的早期指標感到滿意，包括處方趨勢、醫生和患者的證詞以及有興趣向患者提供這種新療法的保險提供者。

In the third quarter, our outcare business grew 21% to $159 million, reflecting continued growth across both the distribution and government channels. New product launches and continued strong execution by the team are key drivers of this strong performance. Amneal's overall gross margin of 44% in the third quarter was up 30 basis points compared to the same quarter last year, reflecting our new product launches as well as our team's efforts and its costs and improve efficiencies in a sustainable way.

第三季度，我們的外勤護理業務成長 21%，達到 1.59 億美元，反映出分銷和政府管道的持續成長。新產品的推出和團隊持續強勁的執行力是這一強勁表現的關鍵驅動因素。Amneal 第三季的整體毛利率為 44%，比去年同期上升了 30 個基點，這反映了我們新產品的推出以及我們團隊的努力以及成本和效率的可持續提高。

Moving down the P&L. Q3 adjusted EBITDA was $158 million reflects robust revenue growth, SG&A expense leverage and includes $20 million related to the licensing of a proposed biosimilar to Xolair that we announced last July. Excluding this milestone payment, adjusted EBITDA growth in Q3 was approximately 15%. From an EPS perspective, Q3 adjusted EPS of $0.16 declined $0.03 as higher adjusted EBITDA was offset by interest expense.

降低損益表。第三季調整後的 EBITDA 為 1.58 億美元，反映了強勁的收入成長、銷售、一般及行政費用槓桿，其中包括與我們去年 7 月宣布的擬議 Xolair 生物仿製藥許可相關的 2000 萬美元。除此里程碑付款外，第三季調整後的 EBITDA 成長約為 15%。從每股盈餘角度來看，第三季調整後的每股盈餘為 0.16 美元，下降了 0.03 美元，因為更高的調整後 EBITDA 被利息支出所抵銷。

Looking at our performance during the first nine months of the year, we are pleased by the quality of execution by all our teams. Total company revenues of $2.1 billion are up 16% while adjusted EBITDA of $472 million is up 13%. It's worth noting that all our business segments have contributed to this growth, and we have thoughtfully increased our investments in R&D and commercial teams as we build a durable high-growth company for many years to come.

回顧今年前九個月的表現，我們對所有團隊的執行品質感到滿意。公司總營收為 21 億美元，成長 16%，調整後 EBITDA 為 4.72 億美元，成長 13%。值得注意的是，我們所有的業務部門都為這一增長做出了貢獻，並且我們深思熟慮地增加了對研發和商業團隊的投資，以便在未來許多年內打造一家持久的高成長公司。

Turning now to cash flow on the balance sheet. Our strong financial performance and discipline is translating into higher cash generation and continued delevering. Consequently, over the last three quarters, we have paid down $127 million in gross debt and reduced our net leverage to 4.2 times at the end of September 2024, and compared to 4.8 times in December 2023.

現在來談談資產負債表上的現金流。我們強勁的財務表現和紀律正在轉化為更高的現金創造能力和持續的去槓桿。因此，在過去三個季度中，我們償還了 1.27 億美元的總債務，並將淨槓桿率從 2023 年 12 月的 4.8 倍降至 2024 年 9 月底的 4.2 倍。

Furthermore, I'm pleased to report that we now expect to finish this year at a net leverage of about 4 times, one year ahead of our original target, and we continue to intend to drive further delevering towards 3 times in the next few years. From a capital allocation perspective, we continue to prioritize investments to further diversify our business and drive sustainable growth. We can expect us to continue making targeted investments in areas such as Parkinson's, biosimilars, injectables and inhalation.

此外，我很高興地報告，我們預計今年的淨槓桿率將達到4倍左右，比我們最初的目標提前了一年，而且我們打算在未來幾年繼續推動淨槓桿率進一步降低至3倍。從資本配置的角度來看，我們繼續優先投資，以進一步實現業務多元化並推動永續成長。我們可以預期我們將繼續在帕金森氏症、生物相似藥、注射劑和吸入劑等領域進行有針對性的投資。

Within R&D, as Chintu mentioned we are reallocating spend towards higher growth areas while maintaining the yearly productivity of our R&D pipeline. We're very excited about our recent GLP-1 collaboration, given its growth potential and our ability to properly support it well within our cash flow profile. In summary, we're laser focused on delivering near-term consistent financial performance, while taking strategic actions to further solidify our long-term growth.

在研發領域，正如 Chintu 所提到的，我們正在將支出重新分配到更高成長領域，同時保持研發管道的年生產力。我們對最近的 GLP-1 合作感到非常興奮，考慮到它的成長潛力和我們在現金流狀況內對其進行適當支持的能力。總之，我們專注於實現近期穩定的財務業績，同時採取策略行動進一步鞏固我們的長期成長。

Let me now turn the call back to Chirag.

現在讓我把電話轉回給 Chirag。

Thank you, Tasos. Our bold strategic vision for Amneal is becoming a reality more and more each day. Over the past five years of the journey, we focused on transforming and diversifying the business. In retail generics, we shifted our portfolio focus to complex products starting back in 2019. In 2020, we acquired the healthcare distribution business to add new channels to drive access to our products. Then in 2021, we started expanding our injectable business by adding new products, capabilities and capacity.

謝謝你，塔索斯。我們對 Amneal 的大膽戰略願景正日益成為現實。在過去五年的歷程中，我們專注於業務轉型和多元化。在零售仿製藥方面，我們從 2019 年開始將產品組合重點轉向複雜產品。2020 年，我們收購了醫療保健分銷業務，以增加獲取我們產品的新管道。然後在 2021 年，我們開始透過增加新產品、新功能和新產能來擴展我們的注射業務。

In 2022, we launched our first biosimilars and built our initial pipeline from there. Internationally, we have laid a strong foundation for long-term growth. The launch of CREXONT and our entry into GLP-1 space in Q3 are very significant milestones for the company, as we execute our strategy, further diversify and drive sustainable growth, we are building Amneal as a leading diversified global pharmaceutical company.

2022 年，我們推出了首款生物相似藥，並從此建立了初始產品線。在國際上，我們為長期發展奠定了堅實的基礎。CREXONT 的推出和我們在第三季度進入 GLP-1 領域對公司來說都是非常重要的里程碑，隨著我們執行策略、進一步多元化和推動永續成長，我們正在將 Amneal 打造為領先的多元化全球製藥公司。

Let's now open the call for Q&A, Tony?

現在讓我們開始問答環節，東尼？

(Operator Instructions) David Amsellem from Piper Sandler.

（操作員指示）Piper Sandler 的 David Amsellem。

Thanks. So just have a few I wanted to start with CREXONT. And I know early days regarding the rollout. But can you talk about the reimbursement landscape, particularly Part D and how we should think about access. And regarding adoption, how are you thinking about that in the context of the eventual loss of exclusivity for Rytary. So that's number one.

謝謝。我只想從 CREXONT 開始說幾點。我也知道有關推出的早期階段的情況。但是您能談談報銷情況嗎，特別是 D 部分，以及我們應該如何考慮獲取醫療服務。關於採用，在 Rytary 最終失去獨家經營權的背景下，您如何看待這個問題。這是第一點。

Number 2 is on your injectable business. I know you've talked about shortage products, and you've also leaned into more complex products. Trying to get a better sense of the mix the -- topline mix for injectables with respect to shortage products and more complex products? And how do you think that mix will evolve over time as you continue to build that part of the business?

第二個是關於你的注射業務。我知道您談到了短缺產品，您也傾向於更複雜的產品。試圖更了解注射劑的頂線組合與短缺產品和更複雜產品之間的關係？隨著您繼續建立該部分業務，您認為這種組合將如何隨著時間的推移而發展？

And then lastly, a product-specific question. I believe you've been developing an intranasal epinephrine product. Any updates on that would be helpful. Thank you.

最後，是關於產品的具體問題。我相信您一直在開發一種鼻內腎上腺素產品。任何有關此的更新都會有幫助。謝謝。

Good morning, David. So CREXONT, off to a great start. We are actually pleasantly surprised by ourselves how the product is doing. It's like CREXONT is marketing CREXONT, and excess so far, good initial coverage, it's just been a few months and great discussion with rest of the payers. We expect to get more coverage than Rytary because what product is doing. So that's the answer to your first question.

早安，大衛。所以 CREXONT 已經有了一個很好的開始。我們實際上對產品的表現感到驚喜。這就像 CREXONT 在行銷 CREXONT，到目前為止，情況過剩，初步覆蓋良好，這才幾個月，並與其他付款人進行了很好的討論。我們希望獲得比 Rytary 更多的報道，因為產品正在發揮作用。這就是你第一個問題的答案。

LOE of Rytary, which is August 1, 2025, should not have much of an impact at all because this is -- we're expanding the market. We're going to pretty much all qualified or people who should be taking CD/LD and converting the market from IR. We have the naive patient labeling and from Rytary or other small portion of the XR all of them took CREXONT, which is the most advanced product today available for Parkinson's patient. There is no excuse why they're not all should be on it. So we're we're going for a massive market share for this product.

Rytary 的 LOE 是 2025 年 8 月 1 日，這應該不會產生太大影響，因為這是——我們正在擴大市場。我們將面向幾乎所有合格人員或應該接受 CD/LD 並將市場從 IR 轉換的人。我們對未經治療的患者進行了標記，他們從 Rytary 或其他小部分 XR 中全部服用了 CREXONT，這是目前可用於帕金森氏症患者的最先進的產品。沒有任何理由不讓他們全部參與其中。因此，我們要為該產品爭取龐大的市場佔有率。

And this is why we're pricing affordability, we have done an extensive work to set it up properly, and we are receiving the feedback we had expected for the market access. So no impact on LOE, obviously, we'll we lose LOE in August 1, but CREXONT and ONGENTYS and the other growth drivers of the company continue to drive growth for 2025 and beyond tremendous growth for me.

這就是我們制定可負擔價格的原因，我們做了大量工作來正確設定它，並且我們正在收到我們預期的市場准入回饋。因此對 LOE 沒有影響，顯然，我們將在 8 月 1 日失去 LOE，但 CREXONT 和 ONGENTYS 以及公司的其他成長動力將繼續推動 2025 年及以後的成長，這對我來說是巨大的成長。

Your second question on injectable, complex, I'll hand it to my brother, but we're doing both the shortages and complex products continue to provide both and also we are converting the compounded products, which always gets into the FDA's crosshairs for the GMP and other reliability. We had our first launch of potassium prospect just recently, and it has been received really well in the market. It's pretty much everybody wants to use FDA-approved product rather than compounded products. And we're working on a few more, but Chintu can shed a little bit more color on it. Go ahead, Brother.

您關於注射劑、複合物的第二個問題，我會把它交給我的兄弟，但我們同時在解決短缺問題，並繼續提供複合產品，同時我們還在轉換複合產品，這始終成為 FDA 對 GMP 和其他可靠性的關注焦點。我們最近首次推出了鉀礦勘探項目，並在市場上獲得了一致好評。幾乎每個人都想使用 FDA 批准的產品，而不是複合產品。我們正在製作更多內容，但 Chintu 可以為其增添更多色彩。繼續吧，兄弟。

Good morning, David. So on injectables, we are very excited with our pipeline and infrastructure and the time we spent over the last four years in creating this. So we have a very good mix of complex products and shortages are very hard to predict, but we do have the capabilities and capacity and the mix of the product. And we are always working with FDA drug shortage group to proactively work as and when we get a request, we keep eye on the drug shortages. We are very purpose driven when it comes to shortages and how we can help alleviate the shortage.

早安，大衛。因此，在註射劑方面，我們對我們的管道和基礎設施以及過去四年來創造這一產品所花費的時間感到非常興奮。因此，我們擁有非常好的複雜產品組合，短缺很難預測，但我們確實具備能力、產能和產品組合。我們一直與 FDA 藥品短缺小組合作，積極開展工作，一旦收到請求，我們就會密切關注藥品短缺情況。當談到短缺問題以及如何幫助緩解短缺時，我們非常有目標。

So our portfolio is very nicely balanced in different categories of injectable. We have LBB bags. Some of them always goes on a shortage and we have excess capacity, we have the vial capabilities, PFS, we have the immersion line like a product like Propofol. We have plan to get capacity. So we'll be able to cater to the shortage as and when it happen. We have a very good complex portfolio also in microspheres, and we expect to receive our approval in next quarter or so for our first microsphere product. We have liposomal, we have the suspension-based product.

因此，我們的產品組合在不同類別的注射劑中實現了很好的平衡。我們有 LBB 包。有些藥品總是短缺，而我們卻有過剩的產能，我們有小瓶生產能力，PFS，我們有像丙泊酚這樣的產品那樣的浸沒線。我們有計劃提高產能。因此，當出現短缺時，我們將能夠及時解決。我們在微球領域也有非常好的複雜產品組合，我們預計我們的第一個微球產品將在下個季度左右獲得批准。我們有脂質體，有懸浮液產品。

So I think it's a very mixed revenue perspective, of course, complex will drive a lot more on a revenue and a topline than the shortage and we have the right-sized infrastructure. So that's a very good mix, and we have the scientific capabilities of developing even the next generation of complex injectable as we announced with GLP-1 drug device combination and auto injectors.

所以我認為這是一個非常複雜的收入視角，當然，複雜的收入和營業額將比短缺更多地推動，而且我們擁有合適規模的基礎設施。這是一個非常好的組合，我們擁有開發下一代複雜注射劑的科學能力，正如我們宣布的 GLP-1 藥物裝置組合和自動注射器。

So very nicely balanced portfolio. We have about 30 or so pending approvals at FDA. So our injectable is a very good mix. Very hard to say each one from the percentage because shortages are not known. Regarding Neffy we are very excited about our own product, our Adrenaclick auto-injector that is doing really well. This is the emergency drug. We are not expecting any challenges to our current business. Actually, it's growing. It's a preferred route because of the emergency for the parents. Neffy also, we have the capabilities on a unique dose nasal spray. So as of today, we are not seeing any impact or we don't expect to see any impact going forward on our current product.

因此，投資組合的平衡非常好。我們有大約 30 個產品正在等待 FDA 的批准。所以我們的注射劑是非常好的混合物。由於不知道短缺情況，因此很難根據百分比說出每一個。關於 Neffy，我們對我們自己的產品 Adrenaclick 自動注射器感到非常興奮，它表現得非常好。這是急救藥。我們預計目前的業務不會面臨任何挑戰。事實上，它正在增長。由於父母有緊急情況，這是首選路線。Neffy 另外，我們還具有發展獨特劑量鼻腔噴劑的能力。所以截至今天，我們還沒有看到任何影響，或者我們預計不會看到對我們目前產品的任何影響。

And Neffy, so far, we have not seen any greater uptake or anything in the market. And we will provide more highlight into our plan going forward on a unit dose nasal spray of epinephrine.

至於 Neffy，到目前為止，我們還沒有看到市場上有任何更大的成長或任何變化。我們將在未來計劃中更加重點關注腎上腺素單劑量鼻噴劑。

Thank you.

謝謝。

Balaji Prasad.

巴拉吉普拉薩德。

Hi, good morning, everyone. Firstly, congratulations on the Metsera deal. Looking at it, it seems to have the potential to redefine Amneal over the longer term. So my first question is on that. Can you provide a bit more financials around the deal? What does this mean in terms of incremental CapEx for Amneal over the coming years and the balance sheet back. And maybe also discuss the longer-term goals that you have with this deal. That's one.

大家早安。首先，恭喜您與 Metsera 達成交易。從長遠來看，它似乎有潛力重新定義 Amneal。我的第一個問題就是關於這個。您能否提供更多有關該交易的財務資訊？這對於 Amneal 未來幾年的增量資本支出和資產負債表意味著什麼。或許還可以討論一下您在這筆交易中的長期目標。那是一個。

Two, maybe a follow-up on CREXONT. Could you describe in detail a bit more on the feedback with the product now. How has the protocol emerged for converting from existing drugs, Sinemet to CREXONT or Rytary and competition from other products too.

二，可能是對 CREXONT 的後續行動。您能否詳細描述一下現在該產品的回饋？從現有藥物 Sinemet 轉換為 CREXONT 或 Rytary 的協議是如何出現的，以及其他產品的競爭如何。

Hey, Balaji. Good morning. So you're correct, Metsera deal puts us into the next generation of growth. And it is very -- it's next level of partnership as well. And this is in peptides and biologics and expect us to do more announcement in a similar line.

嘿，巴拉吉。早安.所以你說得對，Metsera 交易將使我們進入下一代成長。這也是更高層次的合作。這是在勝肽和生物製劑領域，希望我們在類似領域做更多公告。

So first of all, we create a massive capacity and capabilities to supply peptides-based product, which is starting with on obesity, metabolic disease and then continue to do more partnership beyond Metsera or even approach big players like Lilly, Novo, Roche to do CMO work for them. So that is why it's very strategically how we have set it up.

因此，首先，我們創造了龐大的產能和能力來供應基於勝肽的產品，首先針對肥胖症和代謝疾病，然後繼續在 Metsera 之外建立更多合作夥伴關係，甚至與 Lilly、Novo、Roche 等大公司接洽，為他們開展 CMO 工作。這就是我們如此策略性地設置它的原因。

And on top of it, it obviously allows us to get ready for the GX entry with power -- I mean, big capacity. So could be 10 filers, but who could really supply globally at a high-quality product. And that is what we're being -- we are setting it up, both on all injectables.

最重要的是，它顯然使我們能夠為 GX 的強大功能做好準備——我的意思是，大容量。因此可能有 10 個申請人，但誰真正能夠在全球範圍內供應高品質的產品。這就是我們正在做的事情——我們正在對所有註射劑進行設定。

On the financial terms, as we disclosed, Metsera is providing $100 million towards the CapEx and our net expense over the next four to five years is about $50 million to $200 million, so well within our budgets, so not a big deal.

就財務方面而言，正如我們所披露的，Metsera 將提供 1 億美元的資本支出，而我們未來四到五年的淨支出約為 5000 萬至 2 億美元，這完全在我們的預算之內，所以問題不大。

And this is why we are putting the first phase in India. In the future, obviously, we will always like some portion to be produced in the United States, both oral and injectables, which will do so going forward in the United States as well.

這就是我們將第一階段放在印度的原因。顯然，未來我們始終希望一部分藥物在美國生產，包括口服藥物和注射藥物，這些藥物未來也將在美國生產。

Moving on to CREXONT, as I just explained, CREXONT is very novel. It's the best in the class right now. it doesn't too much compete with the more -- even though the results could be same as a continuous pump that every launch, and that is for more advanced patient at $120,000 WACC versus CREXONT is a daily use, naive patient all the way to the advanced patient can use this.

繼續討論 CREXONT，正如我剛才解釋的那樣，CREXONT 非常新穎。這是目前班上最好的。它不會與更多產品競爭太多——儘管結果可能與每次發射的連續泵相同，但對於更高級的患者來說，WACC 為 120,000 美元，而 CREXONT 是每日使用的，從初級患者到高級患者都可以使用它。

So the universe is so big just in the United States market number of patients. And our marketing strategy is we're going after all of that business from naive to Rytary to Sinemet to AbbVie doesn't matter to us. We're because what our product does and what we have seen so far and the affordability of whole product that it can have a wider market access. And this is why we set it up this way because we really wanted to reach many patients. What's the use of innovation if it cannot reach the patients. And that's the Amneal philosophy and that's how we have launched it. Joe, would you like to add?

僅就美國市場的患者數量而言，這個數字就非常大。我們的行銷策略是追求所有的業務，從 Naive 到 Rytary，從 Sinemet 到 AbbVie，對我們來說都無所謂。因為我們的產品的功能、我們目前所見以及整個產品的價格合理，所以它可以獲得更廣泛的市場准入。這就是我們這樣設定的原因，因為我們確實想要覆蓋更多的患者。如果創新無法惠及患者，那創新還有什麼用呢？這就是 Amneal 的理念以及我們推出它的方式。喬，你想補充一下嗎？

Yeah. Balaji, thanks for the question around CREXONT. I would just add to what Chirag said is that our goal has always been to demonstrate the fact that we're the number 1 company in the Parkinson's space. The addition of CREXONT absolutely allows us to do that. And there were really three key aspects to our strategy around your question. One was ensuring that patients saw this product as one that they had accessibility to and were excited about, and we are very pleased with the response we got from the Parkinson's community.

是的。Balaji，感謝您提出有關 CREXONT 的問題。我只想補充一下 Chirag 所說的話，我們的目標一直是證明我們是帕金森氏症領域第一的公司。CREXONT 的加入絕對可以讓我們做到這一點。圍繞您的問題，我們的策略實際上有三個關鍵方面。一是確保患者認為這個產品是他們可以接觸到的，並且對此感到興奮的產品，我們對帕金森氏症患者群體的反應感到非常滿意。

The second, which is kind of goes to your question around conversion and dosage. The HCPs were a critical aspect of our second part of our strategy, which was ensuring that the HCPs or health care providers saw CREXONT as differentiation, clinically different than what they saw in other products in the market. And the good news is the feedback we've heard as the health care providers absolutely see CREXONT as a clinical differentiator and their response and feedback has been that the dosing is very easy for them to convert, whether it be a Rytary patient or a patient on CD/LD or a naive patient to Chirag's point.

第二，這與你關於轉換和劑量的問題有關。HCP 是我們策略第二部分的關鍵方面，該部分旨在確保 HCP 或醫療保健提供者將 CREXONT 視為差異化產品，與市場上其他產品在臨床上有所不同。好消息是，我們聽到的回饋是，醫療保健提供者絕對將 CREXONT 視為一種臨床差異化因素，他們的回應和回饋是，劑量對他們來說很容易轉換，無論是 Rytary 患者、CD/LD 患者還是 Chirag 所說的初治患者。

And then last to the question, you had -- that was asked earlier by David, which is the market access strategy, which was our third strategy component was ensuring we got access comparable, but not broader, than what we saw with Rytary, which had about a 70% national average access. With CREXONT we're very pleased with the response from the payers so far. We've already tapered a few deals, and we are looking to go at least 50% coverage by next year.

最後一個問題，David 之前問過，即市場准入策略，這是我們的第三個策略組成部分，確保我們獲得的准入與 Rytary 相當，但不比 Rytary 的准入範圍更廣，Rytary 的全國平均准入率約為 70%。對於 CREXONT，到目前為止，我們對付款人的回饋非常滿意。我們已經完成了一些交易，並希望到明年能達到至少 50% 的覆蓋率。

And the trend that we're on now with some of the deals we're in conversations with looks like we'll probably be able to get that, if not more, next year. So the access response from the payers has also been very positive. So hopefully, that gets to some of the questions you had about CREXONT as well.

從我們現在正在洽談的一些交易的趨勢來看，明年我們可能就能實現這一目標，甚至更多。因此，付款人的訪問回應也非常積極。希望這也能解答您對 CREXONT 的一些疑問。

That's very helpful. If I could just add in a follow-up question here. Chirag, even discussed making America on multiple firesides in the past, even last year's CEO panel at AM. So with the change in administration coming, can you talk about the implications of an America-centric manufacturing for generics and biosimilars, and how that could -- would influence Amneal's growth strategy over the coming years?

這非常有幫助。如果我可以在這裡添加一個後續問題。Chirag 甚至在過去多次爐邊談話中討論過打造美國，甚至在去年 AM 的 CEO 小組討論中也是如此。那麼，隨著政府權力的變動即將到來，您能談談以美國為中心的製造對仿製藥和生物仿製藥的影響嗎？

Yeah. Thanks, Balaji. So we have an issue as a country in case of emergencies, we need to build a resilient supply chain. And what I mean by resilient is having multiple locations, countries, supplying the friends, shoring and onshoring because sometimes it will be hard to, in the cases of hopefully never happens like wars or some kind of pandemics or national disaster, we could have issues importing antibiotics.

是的。謝謝，巴拉吉。因此，作為一個國家，我們面臨一個問題，在緊急情況下，我們需要建立一個有彈性的供應鏈。我所說的彈性是指擁有多個地點和國家，為朋友提供岸上和在岸供應，因為有時會很困難，在希望永遠不會發生的情況下，例如戰爭或某種流行病或國家災難，我們可能會在進口抗生素方面遇到問題。

The critical 40 or 50 products that we've been -- law being, I would -- advocating in Congress and in White House and both sides of the aisle are completely receptive. We have advanced the agenda for those products the starting material API and finished dosage for the Medicare portion, which is about 45% to 50% market share, Medicare giving different reimbursement for those products. It's legislatively passed, so it's a law, and it creates open market for anybody to invest in America, build these plants to supply these critical medicines. So I think we get that done this time.

我們一直在國會、白宮和兩黨倡導的 40 或 50 種關鍵產品（我想是法律）都得到了完全接受。我們已經為這些產品的起始原料 API 和成品劑量製定了針對醫療保險部分的議程，這部分市佔率約為 45% 至 50%，醫療保險對這些產品提供不同的報銷。它是透過立法通過的，所以它是一項法律，它為任何人在美國投資、建立這些工廠來供應這些關鍵藥物創造了開放的市場。所以我認為我們這次可以完成這個任務。

Thank you.

謝謝。

Leszek Sulewski from Truist Securities.

Truist Securities 的 Leszek Sulewski。

Good morning. Thank you for taking my questions. I just want to focus on the GLP-1 Metsera partnership. So after that announcement, has this raised awareness of your manufacturing capability. And have you been approached by other clinical-stage peptide biotechs for similar partnerships.

早安.感謝您回答我的問題。我只想關注 GLP-1 Metsera 合作夥伴關係。那麼在那次公告之後，這是否提高了人們對你們製造能力的認識。有其他臨床階段的勝肽生物技術公司與您接洽過類似的合作嗎？

And then remind us, what is your current capacity is sterile injectable peptides? And how much additional volume would you anticipate from the new facilities? And what percentage of that increased capacity would you anticipate to be allocated to Metsera's product versus capacity to capture other brands including Lilly or Novo as you mentioned.

然後提醒我們，您目前的無菌注射勝肽的產能是多少？您預計新設施將帶來多少額外的產量？您預計增加的產能中有多少百分比將分配給 Metsera 的產品，以及有多少百分比將分配給您提到的 Lilly 或 Novo 等其他品牌的產品。

Also, is there a path for you to capture the generic side of some of these blockbuster GLP-1s come LOE? And then lastly, what do you expect the response will be from some of your manufacturing competitors in the space?

另外，您是否有辦法捕捉到 LOE 中一些重磅 GLP-1 的通用方面？最後，您預計該領域的一些製造業競爭對手會如何反應？

Yeah, good morning. So let me start with our current capacity. On the PFS cartridge, we can make up to 5 million units, a very small capacity for peptides API as of today. In the next few years, three years or so, we would increase our capacity to make 5 to 10 turns of API drug substance and 100 million of combination of PFS and cartridges, whichever our client chooses to use with full assembly. So that's the phase for the next three years on a capacity-wise.

是的，早安。那麼讓我先從我們目前的產能開始說。在 PFS 墨盒上，我們可以生產多達 500 萬個單位，這對於今天的勝肽 API 來說是一個非常小的容量。在未來的幾年，大概三年左右的時間裡，我們將提高產能，生產 5 到 10 個 API 藥物物質和 1 億個 PFS 和墨盒組合，無論我們的客戶選擇使用哪種完整組裝。從產能角度來看，這就是未來三年的階段。

We would -- yes, we've been approached by big guys as well. So we will obviously work with them and see how we can help them to introduce these very important drug globally and create access to other countries as well, affordable access. So we have that opportunity as well with us. And on -- as far as GX is concerned, we would be ready whenever the LOE happens, and we will have full capacity to supply GX products at that time, if we need to add another 100 million units, we can because the infrastructure will be there.

我們會的 — ​​— 是的，我們也曾被大公司接洽過。因此，我們顯然會與他們合作，看看我們如何幫助他們在全球範圍內推出這些非常重要的藥物，並以可承受的價格將其引入其他國家。所以我們也有這樣的機會。就 GX 而言，無論何時發生 LOE，我們都會做好準備，屆時我們將有充足的產能供應 GX 產品，如果我們需要再增加 1 億台，我們可以做到，因為基礎設施已經準備好了。

And if we have to expand API, we will because we have all the capabilities -- capacity already built in and then just extending the site. So that is the strategy for us to play in GLP-1 or all peptides within the obesity and metabolic space, and that could further expand to other peptides enzyme driven products as well.

如果我們必須擴展 API，我們會這樣做，因為我們已經具備所有功能 —— 容量已經內置，然後只需擴展站點。因此，這是我們在 GLP-1 或肥胖和代謝領域內所有勝肽發揮作用的策略，並且還可以進一步擴展到其他肽酶驅動產品。

And just lastly on the competitors' response, have you seen anything out there yet?

最後，關於競爭對手的反應，你已經看到什麼了？

No. This is a very unique partnership. It took us a year and a very old partnership knowing it's a trusted partnership, and we're doing beyond CDMO work here. we're codeveloping the products, helping them on CMC, clinical and production. So both oral and injectable side, the formulation enhancement. So this is very unique, and we haven't seen anybody else doing that. But I'm sure people may follow this model.

不。這是一個非常獨特的合作關係。我們花了一年的時間，建立了非常長期的合作夥伴關係，知道這是值得信賴的合作夥伴關係，而且我們在這裡所做的工作超越了 CDMO 工作。我們正在共同開發產品，並在 CMC、臨床和生產方面為他們提供協助。因此，無論是口服還是注射，配方都得到了增強。這是非常獨特的，我們還沒有看到其他人這樣做。但我確信人們可能會效仿這種模式。

Got it. Thank you so much for that color.

知道了。非常感謝這個顏色。

Chris Schott from JPMorgan.

摩根大通的 Chris Schott。

Alright, great. Thanks so much. Congrats all the progress on the business. Just three for me. Maybe first on business development. Can you just talk about the landscape for deals here? And it just seems like the business is growing, you get more capabilities for investing behind assets. Just maybe a little bit more color on kind of the size and stage of assets you're most interested in?

好的，太棒了。非常感謝。祝賀業務上取得所有進展。對我來說只有三個。也許首先是業務發展。您能談談這裡的交易情況嗎？而且看起來業務正在成長，您獲得了更強的資產投資能力。您能否更詳細地介紹一下您最感興趣的資產的規模和階段？

The second question, biosimilars. Just talk a little bit about the opportunity and competitive landscape you're thinking about in that market? And then finally, just on '25, just any initial color you can provide in terms of just thinking about pushes and pulls as we think about the outlook for next year?

第二個問題，生物相似藥。請稍微談談您在該市場中考慮的機會和競爭格局？最後，就在 25 月份，當我們考慮明年的前景時，您能否就推動和拉動因素提供任何初步的資訊？

Thank you, Chris. So the business development front, as we continue to obviously -- we want to delever. So we have that in mind, but we do generate $300-plus million operating cash flow. So we do have certain capabilities, and we are very, very focused on getting down into 3s as far as the leverage is concerned. And the deals we're looking at and would be adding is two areas, specialty products, and it's very smart additions because we have limited R&D budget and limited cash, but there are so many opportunities that we see and using Amneal's capabilities and Amneal's 1,000 scientists and all the CMC and other capabilities clinical, we could have a unique partnership on the specialty assets.

謝謝你，克里斯。因此，在業務發展方面，我們顯然希望繼續去槓桿。所以我們考慮到了這一點，但我們確實產生了 3 億多美元的營運現金流。因此，我們確實具備一定的能力，而且就槓桿率而言，我們非常非常注重將比率降至 3。我們正在考慮並將要增加的交易是兩個領域，即特種產品，這是非常明智的補充，因為我們的研發預算和現金有限，但我們看到了很多機會，利用 Amneal 的能力和 Amneal 的 1,000 名科學家以及所有 CMC 和其他臨床能力，我們可以在特種資產上建立獨特的合作夥伴關係。

We could take some of the commercial assets. Oncology is our new focus on specialty. So far, we've been focused on CNS and we have key products in endocrinology. We're now going in Onco because of the biosimilars, we have a whole pipeline of oncology products, the same touch points so why not introduce the branded products as well within the same community, we hear them the need for it. It will be a specialty products, so we're not competing with big guys. But there are opportunities. So you will see us doing those deals and bringing those into our specialty pipeline.

我們可以獲得一些商業資產。腫瘤學是我們新的重點專業。到目前為止，我們一直專注於中樞神經系統，並且在內分泌學領域擁有主要產品。我們現在進入 Onco 是因為生物仿製藥，我們擁有完整的腫瘤產品線，相同的接觸點，所以為什麼不在同一個社區內推出品牌產品，我們聽到了他們對它的需求。這將是一種特色產品，因此我們不會與大公司競爭。但機會也存在。所以你會看到我們做這些交易並將其納入我們的專業管道。

The second would be biosimilar. We would love to integrate completely and head-on compete with Sandoz, Celltrion, Amgen. So we'll have -- we would like to have a full capacity of development add on another 8, 10 programs, which are done over four, five years, manufacturing capacity, so full R&D capacity, manufacturing at scale like a 30,000, 40,000, 50,000 liter scale. We already -- so -- and keep expanding partnership within biosimilars. We want -- we see this as a big market. It is -- and only seven, eight competitors would pretty much share most of the revenue between.

第二種是生物相似藥。我們希望全面整合並與 Sandoz、Celltrion、Amgen 展開正面競爭。因此，我們希望擁有全面的開發能力，加上另外 8、10 個項目，這些項目將在四五年內完成，同時還擁有製造能力，即全面的研發能力，以及 30,000、40,000、50,000 公升等規模的生產能力。我們已經並將繼續擴大生物相似藥領域的合作夥伴關係。我們希望——我們認為這是一個巨大的市場。確實如此——只有七、八家競爭對手可以分享大部分收入。

It's a little broad range I'm giving $20 billion to $30 billion so this is manufactures' net sales, IQVIA could be $50 billion, $60 billion. So that is large. And you can see seven or so company Biocon, Sandoz and Amneal, integrated play with Alvotech. Celltrion is there. There are a couple more will show up. But we sit very pretty to take the leadership role there or among the leading companies for biosimilars. And it's a global play. There's a huge demand for these products globally.

範圍比較大，我給的是 200 億到 300 億美元，這是製造商的淨銷售額，IQVIA 可能是 500 億美元、600 億美元。所以這很大。您可以看到大約有 7 家公司 Biocon、Sandoz 和 Amneal 與 Alvotech 整合運作。Celltrion 就在那裡。還有幾個會出現。但我們在該領域或說在生物相似藥領域的領先公司中佔據著非常有利的地位。這是一部全球性的戲劇。全球對這些產品的需求龐大。

So it could have a split of 60% revenue coming from US, 40% from the rest of the world, which we'll partner for these assets. So integration of biosimilar on the BD side is key priority in '25. Healthcare is a great business, but we are keeping it it's such a great business. It's growing double digits, huge growth opportunity there as we expand into government distribution partnership with government.

因此，我們的收入 60% 來自美國，40% 來自世界其他地區，我們將與這些地區合作獲取這些資產。因此，BD 方面生物相似藥的整合是 '25 年的首要任務。醫療保健是一項偉大的事業，但我們仍認為它是一項偉大的事業。隨著我們與政府擴大分銷合作夥伴關係，它的成長率達到兩位數，這意味著巨大的成長機會。

We love that business and certain direct distribution to hospitals and consumer like California, for naloxone, we are distributing directly. So it allows us to do direct distribution, which is a niche other competitors may not have in our field as we built Amneal to last for a long time.

我們熱愛這項業務以及向加州等醫院和消費者直接分銷納洛酮的業務，我們是直接分銷的。因此，它使我們能夠進行直接分銷，這是其他競爭對手在我們的領域可能沒有的利基市場，因為我們建立的 Amneal 可以持續很長時間。

And then on the biosimilar Xolair, we -- the three competitors, known competitors at a stage we are Celltrion has, I believe, filed the product, Teva and us with Kashiv. And we expect to file in the second half next year, get the approval in pretty much than 10 months, and we have a manufacturing would be -- our partner is doing it in Piscataway, New Jersey. And based on IP or we expect to launch this in January 1, '27 but it's pending IP settlement or however it works out. I am not sure about it.

然後關於生物相似藥 Xolair，我們 - 三個競爭對手，目前已知的競爭對手是 Celltrion，我相信，Teva 和我們已向 Kashiv 提交了該產品。我們預計將在明年下半年提交申請，並在 10 個月內獲得批准，我們的製造合作夥伴正在新澤西州皮斯卡塔韋進行生產。基於 IP，我們預計將於 27 年 1 月 1 日推出該產品，但它仍有待 IP 解決或其他方式解決。我不太確定。

Chris, just wanted to add on Xolair, also our partner is uniquely positioned to have all the strength, both the even newly launched strength, 175, 150 and 300 plus the auto-injector device. So while they are growing up on the approval, Amneal would enjoy the entire range of Xolair differentiated auto-injector, PFS with different strengths. So -- and a very strong IP position, both. So that will be uniquely differentiate us than our competitors in initial time frame.

克里斯，我只想補充一下 Xolair，我們的合作夥伴也具有獨特的優勢，擁有所有的強度，包括新推出的強度 175、150 和 300，以及自動注射器裝置。因此，在獲得批准的同時，Amneal 將享受 Xolair 全系列差異化自動注射器、具有不同強度的 PFS。所以 — — 兩者都具有非常強大的智慧財產權地位。因此，在初始階段，這將使我們與競爭對手有獨特的差異。

Yeah. And Chris, '25 looks very strong. I'll pass it to Tasos for push and pulls, but we are very excited about '25.

是的。而克里斯，'25 看起來非常強勁。我會將它傳遞給 Tasos 進行推拉，但我們對 '25 感到非常興奮。

So I think the question was early view into 2025 increase and then it pulls, all detractors. So I'll say a couple of things. So we'll give you guidance for next year, at the end of February, but we feel great about next year. Our company is built for growth, and that's how the management team is thinking about the business.

因此，我認為問題在於對 2025 年成長的早期展望，然後它就會吸引所有批評者。因此我要說幾件事。因此，我們將在二月底為您提供明年的指導，但我們對明年充滿信心。我們的公司是為了發展而建立的，這就是管理團隊對業務的看法。

We have driven growth for the last five years throughout COVID and kind of engineering this spectacular financial turnaround, and we're not going to stop after five years. So next year, we expect another year of growth from both the topline, bottom line and cash generation. That's kind of point number one. When we think about kind of tailwinds and headwinds is the obvious headwind is the Rytary LOE.

在過去五年的新冠疫情期間，我們一直推動成長，並實現了驚人的財務好轉，而且我們不會在五年後停下來。因此，我們預計明年我們的營業收入、淨利潤和現金創造能力都將再次成長。這是第一點。當我們考慮順風和逆風時，明顯的逆風就是 Rytary LOE。

Now the vast majority of that will be compensated by the launch of CREXONT. So that's kind of point number one. So I think that becomes more of a speed bump, the right LOE. In addition, our biosimilars will continue to grow. Our institutional business, so the injectable products we've been talking about, those will continue to grow substantially next year and beyond.

現在，絕大部分損失將透過 CREXONT 的推出得到補償。這是第一點。因此我認為這更像是一個減速帶，正確的 LOE。此外，我們的生物相似藥將繼續成長。我們的機構業務，也就是我們一直在談論的注射產品，明年及以後將繼續大幅成長。

In healthcare we'll just continue the growth that it has been on for the last five, six years. And at the same time, when you think about cash generation, we are the clinical of interest expense. So as we think about next year, we will expect about $30 million of reduced interest expense and that's a function of two things. Number one is just reflective fact this year, most likely, we would have paid down about $180 million of gross debt.

在醫療保健領域，我們將繼續保持過去五、六年的成長動能。同時，當您考慮現金產生時，我們是利息支出的臨床。因此，展望明年，我們預計利息支出將減少約 3,000 萬美元，這是由兩件事決定的。第一，今年我們很可能已經償還了約 1.8 億美元的總債務。

We have already paid $127 million, and we probably will pay another $50 million, $60 million of gross debt in Q4. So we're carrying essentially a couple of hundred million dollars less of interest of gross debt. And then as you know, interest rates are beginning to slowly creep down. So a combination of all these biosimilars, health care, injectables, CREXONT and interest -- less interest expense will more than offset whatever we lose in the right of LOE and put the company in another year of growth. Does that help?

我們已經支付了 1.27 億美元，我們可能還會在第四季度支付另外 5,000 萬美元、6,000 萬美元的總債務。因此，我們的總債務利息實際上減少了​​數億美元。然後正如你所知，利率開始緩慢下降。因此，所有這些生物相似藥、醫療保健、注射劑、CREXONT 和利息的組合 - 減少的利息支出將足以抵消我們在 LOE 權利中損失的任何損失，並使公司再實現一年的成長。這樣有幫助嗎？

That's super helpful. I appreciate the color. Maybe just one really quick clarification. If I just look at the Parkinson's franchise as a whole, I guess when we combined the very strong launch so far with the Rytary generics, is that a franchise we should expect to grow next year? Obviously, over time, it grows. But specifically in '25, do you think you can still grow the franchise between those two assets?

這非常有幫助。我很欣賞這個顏色。也許只需要一個非常快速的澄清。如果我只是從整體上看待帕金森氏症的特許經營權，我想當我們將迄今為止非常強勁的發布與 Rytary 仿製藥結合起來時，我們是否應該期待明年的特許經營權會增長？顯然，隨著時間的推移，它會增長。但具體到 25 年，您認為您還能在這兩種資產之間發展特許經營權嗎？

Yeah, I think that's a great question, and I have a tendency of driving my friend, Joe here crazy about this. I would say it's a little bit -- It's a little bit the -- we're only a couple of months into the launch. Obviously, that will be -- obviously, that would be our objective. But frankly, even if we don't kind of completely offset the LOE loss next year, right, by a few million dollars in the grand scheme of -- almost $3 billion revenue company, we will be more than able to offset that.

是的，我認為這是一個很好的問題，而且我有點讓我的朋友喬為這個問題而抓狂。我想說的是，這有點——這有點——我們才剛推出幾個月。顯然，那將是——顯然，那將是我們的目標。但坦白說，即使我們不能完全抵消明年的 LOE 損失，從公司近 30 億美元的整體收入來看，我們也足以抵消這筆損失。

And we have also added ONGENTYS Chris, which is growing as part of the franchise.

我們還添加了 ONGENTYS Chris，它正在作為特許經營的一部分不斷成長。

Perfect. Thank you so much.

完美的。太感謝了。

We have no further questions. So I'd like to hand back to Chirag Patel to conclude. Thank you.

我們沒有其他問題了。因此我想把發言權交還給 Chirag Patel 來結束演講。謝謝。

Well, thank you, everybody, and wish you a great weekend. Thank you. .

好吧，謝謝大家，祝大家週末愉快。謝謝。。

This concludes today's call. Thank you for joining. You may now disconnect your lines.

今天的電話會議到此結束。感謝您的加入。現在您可以斷開線路了。