Amneal Pharmaceuticals Inc (AMRX) 2024 Q2 法說會逐字稿

Good morning and welcome to the Amneal Pharmaceuticals second quarter 2024 earnings call. I'd now like to turn the call over to Amneal's Head of Investor Relations, Tony DiMeo.

早安，歡迎參加 Amneal Pharmaceuticals 2024 年第二季財報電話會議。我現在想將電話轉給 Amneal 投資者關係主管 Tony DiMeo。

Good morning and thank you for joining Amneal Pharmaceuticals second quarter 2024 earnings call. Today, we issued a press release reporting Q2 results. The earnings press release and presentation are available at amneal.com.

早安，感謝您參加 Amneal Pharmaceuticals 2024 年第二季財報電話會議。今天，我們發布了一份新聞稿，報告第二季的業績。收益新聞稿和簡報可在 amneal.com 上取得。

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.

本次電話會議中有關非歷史事實的某些陳述，包括但不限於管理層的前景或預測，均為前瞻性陳述，僅基於我們現在掌握的資訊。

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.

請參閱標題為前瞻性陳述的警示性陳述的部分，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原則措施。有關這些措施的使用以及與公認會計原則（GAAP）的調節的資訊在收益發布和演示中。

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 for Specialty; and Jason Daly, Chief Legal Officer.

今天參加電話會議的是共同創辦人兼聯合執行長 Chirag 和 Chintu Patel；塔索斯·科尼達里斯，財務長；我們的商業領袖，仿製藥領域的 Andy Boyer；喬·倫達 (Joe Renda) 專業；和首席法律官 Jason Daly。

I will now hand the call over to Chirag.

我現在將把電話轉交給奇拉格。

Thank you, Tony. Good morning to everyone. We are delighted to report strong Q2 results, raise 2024 guidance and share the recent approval of CREXONT for Parkinson's disease. Today, Amneal is a global diversified pharmaceutical company that provides access to high-quality, affordable and essential medicines for patients, providers and payers. We're a deeply purpose-driven company on a remarkable journey of expanding in key areas of medicine and delivering sustainable long-term growth.

謝謝你，托尼。大家早安。我們很高興報告強勁的第二季業績，提高 2024 年指導，並分享 CREXONT 最近批准用於治療帕金森氏症。如今，Amneal 是一家全球多元化製藥公司，為患者、提供者和付款人提供高品質、負擔得起的基本藥物。我們是一家以目標為導向的公司，正在經歷一段在關鍵醫學領域擴張並實現可持續長期成長的非凡旅程。

Amneal has grown consistently each of last five years. Revenues are up from $1.6 billion in 2019 to over $2.7 billion expected in 2024. Adjusted EBITDA is up from $339 million in 2019 to about $620 million expected in 2024. We could not be more prouder of this progress and the strong foundation we have built.

Amneal 過去五年每年持續成長。收入預計從 2019 年的 16 億美元增至 2024 年的 27 億美元以上。調整後 EBITDA 將從 2019 年的 3.39 億美元增至 2024 年的預期約 6.2 億美元。我們對這項進步和我們所建立的堅實基礎感到無比自豪。

Let me now discuss how well we are positioned for sustainable growth -- long-term growth in each of our businesses. Starting with specialty business, we continue to grow our key branded products in neurology and endocrinology. This week's US approval of CREXONT, formerly known as IPX203, is a watershed moment for Amneal. We are excited to launch CREXONT in September.

現在讓我討論一下我們在永續成長方面的定位如何——我們每項業務的長期成長。從專業業務開始，我們繼續發展神經病學和內分泌學領域的主要品牌產品。本周美國批准 CREXONT（原名 IPX203）對於 Amneal 來說是一個分水嶺。我們很高興在 9 月推出 CREXONT。

Our launch plan and market access strategy leverages 10 years of Rytary commercial experience and our deep market understanding of patients, providers and payers. We expect $300 million to $500 million in US peak sales. In total, with the addition of CREXONT, we expect specialty revenues of over $500 million in 2027. We continue to evaluate branded opportunities to add to our pipeline and we are excited about the future of this segment.

我們的推出計劃和市場准入策略利用了 Rytary 10 年的商業經驗以及我們對患者、提供者和付款人的深入市場了解。我們預計美國的峰值銷售額將達到 3 億至 5 億美元。總的來說，隨著 CREXONT 的加入，我們預計 2027 年特種產品收入將超過 5 億美元。我們繼續評估品牌機會以添加到我們的產品線中，我們對這一領域的未來感到興奮。

Next, our affordable medicines business, which is our Generic segment, has grown consistently every year since 2019. This durable growth profile is driven by ever-expanding portfolio of retail, injectable and biosimilar products.

接下來，我們的平價藥品業務（即我們的仿製藥業務）自 2019 年以來每年都在持續成長。這種持久的成長態勢是由不斷擴大的零售、注射和生物相似藥產品組合所推動的。

For the first half of 2024, revenue growth has accelerated to 14% due to our diverse portfolio of complex and high-demand medicines, robust supply chain and regular cadence to 30 new launches each year. We're number one in quality, complex new product portfolio and customer fulfillment in the United States.

2024 年上半年，由於我們多樣化的複雜且高需求的藥品組合、強大的供應鏈以及每年 30 種新產品的定期上市節奏，收入增長加速至 14%。我們在美國的品質、複雜的新產品組合和客戶滿意度方面排名第一。

In injectables, we have expanded our portfolio to over 40 products for the hospital market with a deep pipeline. We have now tripled our manufacturing capacity to 60 million units to drive growth at scale. Importantly, we are helping to address market shortages in hospitals and clinics as we provide 12 commercial injectables currently on the shortage list.

在註射劑方面，我們已將產品組合擴展到醫院市場的 40 多種產品，並擁有豐富的產品線。現在，我們的製造能力已增加兩倍，達到 6,000 萬台，以推動規模成長。重要的是，我們正在幫助解決醫院和診所的市場短缺問題，因為我們提供了目前短缺名單上的 12 種商業注射。

We are also focused on providing unique ready-to-use 505(b)(2) products that can improve hospital pharmacy efficiency by eliminating medication preparation steps. We have launched our 3 505(b)(2) ready-to-use injectables, with more to come.

我們也致力於提供獨特的即用型 505(b)(2) 產品，這些產品可以透過消除藥物準備步驟來提高醫院藥房效率。我們已經推出了 3 505(b)(2) 即用型注射劑，並將推出更多注射劑。

Turning to biosimilars. We have built a strong business with the successful launch of our first three products and we are on track for over $125 million in revenue in 2024. The next phase of biosimilar growth will come from five additional pipeline products we have added in the past few quarters. They're all expected to launch between 2025 to 2027.

轉向生物相似藥。透過成功推出前三款產品，我們已經建立了強大的業務，預計到 2024 年我們的收入將超過 1.25 億美元。生物相似藥的下一階段成長將來自我們在過去幾季新增的五種產品線。它們預計將於 2025 年至 2027 年期間推出。

With our most recent addition, omalizumab, we have now expanded beyond onco to allergy. This product represents $2.6 billion of US market today and we see a significant biosimilar opportunity for this molecule with less competition.

隨著我們最近添加的奧馬珠單抗，我們現在已將治療範圍從腫瘤擴展到過敏。該產品目前占美國市場價值 26 億美元，我們看到該分子在競爭較少的情況下存在巨大的生物相似藥機會。

Overall, the US biosimilar market is estimated to grow from $4 billion to $5 billion today to $20 billion to $30 billion by 2030 from a manufacturer's perspective. We see biosimilars as the next wave of affordable medicines. With adoption rates over 80%, biosimilars are increasing access and driving affordability to important biologic therapy for patients. We look to build a significant biosimilar portfolio through in-licensing and vertical integration over time to be one of the top global biosimilar players.

總體而言，從製造商的角度來看，美國生物相似藥市場預計將從目前的 40 億至 50 億美元成長到 2030 年的 200 億至 300 億美元。我們將生物相似藥視為下一波負擔得起的藥物。生物相似藥的採用率超過 80%，正在增加患者對重要生物療法的取得並提高其負擔能力。隨著時間的推移，我們希望透過許可和垂直整合建立重要的生物相似藥產品組合，成為全球頂尖的生物相似藥企業之一。

Next, internationally, we are just beginning to gain traction. In India, we are building a customized portfolio of specialty products. In other geographies, we are working with partners to commercialize select Amneal products in key markets and we'll start supplying products in the fourth quarter. We expect international revenues will add $20 million to $30 million in 2025, build to $50 million to $100 million by 2027 and rapidly scale after that. This represents the new growth vector for Amneal in the long term.

接下來，在國際上，我們才剛開始獲得關注。在印度，我們正在建立客製化的特色產品組合。在其他地區，我們正在與合作夥伴合作，在主要市場將精選的 Amneal 產品商業化，我們將在第四季度開始供應產品。我們預計 2025 年國際收入將增加 2,000 萬至 3,000 萬美元，到 2027 年將增至 5,000 萬至 1 億美元，並在此後迅速擴大。從長遠來看，這代表了 Amneal 新的成長向量。

Finally, our AvKARE distribution business has more than doubled since we acquired it in 2020. This robust growth is driven by ongoing expansion across all three of AvKARE's channels: distribution, government and unit dose. We are especially proud to serve military veterans through AvKARE's government channel. Now we expect over $675 million in AvKARE revenue in 2025.

最後，自 2020 年收購以來，我們的 AvKARE 分銷業務成長了一倍以上。這種強勁的成長是由 AvKARE 所有三個管道的持續擴張所推動的：分銷、政府和單位劑量。我們特別自豪能夠透過 AvKARE 的政府管道為退伍軍人提供服務。現在，我們預計 2025 年 AvKARE 的營收將超過 6.75 億美元。

Overall, as we continue to grow and further diversify, we are providing more patient, providers and payers with access to high-quality, affordable and essential medicines as we are having a profoundly positive societal impact. We have demonstrated that our growth is durable and sustainable over the long term. We believe the true potential and value of Amneal is yet to be realized.

總體而言，隨著我們的不斷發展和進一步多元化，我們正在為更多的患者、提供者和付款人提供高品質、負擔得起的基本藥物，因為我們正在產生深遠的積極社會影響。我們已經證明，從長遠來看，我們的成長是持久且可持續的。我們相信 Amneal 的真正潛力和價值尚未實現。

I will now hand it to my brother, Chintu.

現在我將把它交給我的兄弟 Chintu。

Good morning, everyone. Thank you, Chirag and thank you to the global Amneal family, who help make healthy possible with their deep passion, great talents and hard work. I will begin with CREXONT and then discuss our core strength in innovation and operations which we have a long runway for sustainable growth.

大家早安。感謝 Chirag，感謝全球 Amneal 家族，他們以深厚的熱情、卓越的才能和辛勤的工作幫助實現健康。我將從 CREXONT 開始，然後討論我們在創新和營運方面的核心優勢，我們擁有可持續成長的漫長道路。

We're very excited and delighted to receive the US FDA approval of CREXONT that has the potential to change the treatment paradigm for Parkinson's disease. IPX203 has been our number one R&D program for years and its successful approval this week is a remarkable accomplishment by our team.

我們非常興奮和高興地收到美國 FDA 批准 CREXONT，它有可能改變帕金森氏症的治療模式。IPX203多年來一直是我們的第一個研發項目，本週的成功批准是我們團隊的一項了不起的成就。

As a background, Parkinson's disease is a degenerative neurological disorder that severely impacts everyday life. Over 90% of Parkinson's patients today are on carbidopa/levodopa therapyl however, over 40% experience wearing-off symptoms within 2.5 years after diagnosis. Some patients take up to 10 immediate-release doses per day and still experience motor fluctuations. CREXONT promises to ease this burden for patients and improve their daily living.

作為背景，帕金森氏症是一種嚴重影響日常生活的退化性神經系統疾病。目前，超過 90% 的帕金森氏症患者正在接受卡比多巴/左旋多巴治療，但超過 40% 的患者在診斷後 2.5 年內症狀會逐漸消失。有些患者每天服用多達 10 次速釋劑量，但仍會出現運動波動。CREXONT 承諾減輕患者的負擔並改善他們的日常生活。

CREXONT is an innovative formulation consisting of IR granules for rapid onset and ER pellets for long-lasting efficacy. CREXONT delivers more Good On time with less frequent dosing. For Phase 3 post hoc analysis, CREXONT showed 1.6 hours more Good On time per dose than IR. As a leader in the Parkinson's space, we are proud to advance the standard of care for patients.

CREXONT 是一種創新配方，由起效快的速釋顆粒和持久功效的緩釋顆粒組成。CREXONT 以較低的給藥頻率提供更多的良好準時性。對於第 3 階段事後分析，CREXONT 顯示每劑的良好持續時間比 IR 多 1.6 小時。作為帕金森氏症領域的領導者，我們很自豪能夠提高患者的照護標準。

In specialty, we are continually evolving our R&D efforts to move up the value chain. Next up is the DHE auto-injector for migraine and cluster headache. We are on target to complete our ANDA response in quarter four which would put us in a good position to launch in the second quarter of next year once approved.

在專業領域，我們不斷發展我們的研發工作，以朝價值鏈上游邁進。接下來是用於治療偏頭痛和叢集性頭痛的 DHE 自動注射器。我們的目標是在第四季度完成 ANDA 回應，這將使我們能夠在獲得批准後於明年第二季啟動。

Let me touch on our industry-leading complex generics portfolio. We have launched 15 new products year-to-date and are on track to launch over 30 again this year. Our pipeline remains deep with 80 new product ANDA pending, 63% of which are non-oral solids. In addition, we have 65 pipeline products, 94% of which are non-oral solids.

讓我談談我們領先業界的複雜仿製藥產品組合。今年迄今為止，我們已推出 15 款新產品，今年預計將再次推出 30 多種新產品。我們的產品線仍然很深，有 80 種新產品 ANDA 正在等待批准，其中 63% 是非口服固體製劑。此外，我們還有 65 個在研產品，其中 94% 是非口服固體。

Our world-class global infrastructure is optimized and ready to support the commercialization of our pipeline. Within our R&D organization, we have enhanced our efficiency, execution and scientific capabilities to develop complex products on shorter timelines and a lot less cost. As a result, we are allocating more investment toward external R&D, especially in biosimilar and specialty.

我們世界一流的全球基礎設施已經過優化，隨時可以支援我們管道的商業化。在我們的研發組織內，我們提高了效率、執行力和科學能力，能夠在更短的時間內和更低的成本開發複雜的產品。因此，我們正在將更多投資分配給外部研發，特別是在生物相似藥和特殊藥物方面。

I will now touch on a few key programs. First, our recent launch of naloxone nasal spray is going well. With this product, we are expanding access to a critical rescue medicine for treating drug overdoses. We started distribution to retail pharmacies and the state of California in the second quarter.

我現在將談談幾個關鍵項目。首先，我們最近推出的納洛酮鼻噴劑進展順利。透過該產品，我們正在擴大獲得治療藥物過量的關鍵救援藥物的機會。我們從第二季開始向零售藥局和加州分銷。

Next, our first major inhalation product, albuterol sulfate has an FDA goal date in the fourth quarter. This is the first in a series of inhalation launches we have planned over the next several years. We are also on target to file our first Respimat product by the end of 2025. Inhalation is a new vector of growth for our business.

接下來，我們的第一個主要吸入產品硫酸沙丁胺醇的 FDA 目標日期是第四季。這是我們計劃在未來幾年內推出的一系列吸入劑發射中的第一個。我們也計劃在 2025 年底之前提交我們的第一個 Respimat 產品。吸入是我們業務成長的新載體。

In injectables, we launched nine new products so far this year, including our first 505(b)(2) products, PEMRYDI and FOCINVEZ and recently approved potassium phosphate bag. We have developed our 505(b)(2) injectable strategy very uniquely based on feedback from many stakeholders.

在註射劑方面，我們今年迄今推出了九種新產品，包括我們的首款 505(b)(2) 產品、PEMRYDI 和 FOCINVEZ 以及最近批准的磷酸鉀袋。我們根據許多利害關係人的回饋制定了非常獨特的 505(b)(2) 注射策略。

As a result, we have built a curated pipeline of unique injectable product presentations. We look to launch two to three 505(b)(2) injectables each year with about 15 currently in development. Our other complex injectable R&D programs in microspheres, liposomes and the drug/device combinations are also advancing nicely in our pipeline.

因此，我們建立了一系列獨特的注射產品演示的規劃管道。我們希望每年推出兩到三種 505(b)(2) 注射劑，目前正在開發約 15 種。我們在微球、脂質體和藥物/設備組合方面的其他複雜注射研發專案也在我們的管道中順利推進。

Next, in biosimilar, we are thoughtfully expanding our portfolio. Building on the success of our first three commercial products, we have in-licensed fove additional biosimilar pipeline candidates since December of 2023. First, we expect to file our two denosumab biosimilar for Prolia and XGEVA in Q4 this year. After that, we expect to file our pegfilgrastim on-body injector and prefilled auto-injector products.

接下來，在生物相似藥領域，我們正在深思熟慮地擴大我們的產品組合。在我們前三個商業產品取得成功的基礎上，自 2023 年 12 月以來，我們已經獲得了 4 個其他生物相似藥候選產品的許可。首先，我們預計在今年第四季提交 Prolia 和 XGEVA 的兩種地諾單抗生物相似藥。之後，我們預計將提交我們的聚乙二醇非格司亭體內注射器和預填充自動注射器產品。

In addition, we are excited to add omalizumab, our biosimilar for Xolair, to our pipeline. Our partner recently completed Phase 3 trial enrollment with expected BLA filing by quarter four of 2025. This marks our expansion in biosimilars beyond oncology to immunology and our commitment to be a leader in this space. We will opportunistically add more molecules, particularly in less crowded categories to our pipeline and look to be vertically integrated over time.

此外，我們很高興將 Xolair 的生物相似藥 Omalizumab 添加到我們的產品線中。我們的合作夥伴最近完成了第 3 階段試驗註冊，預計將於 2025 年第四季提交 BLA。這標誌著我們將生物相似藥從腫瘤學擴展到免疫學，並致力於成為該領域的領導者。我們將機會主義地添加更多的分子，特別是在我們的管道中不太擁擠的類別中，並希望隨著時間的推移進行垂直整合。

Internationally, we have distribution partners in place for key developed and emerging markets. Our team has completed over 150 product registration filings since last year through the first half of this year. We are registering products globally, including in Europe, Canada, China and emerging markets. International expansion is a key area of focus for us at Amneal.

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。從去年到今年上半年，我們的團隊已經完成了 150 多個產品註冊申請。我們正在全球註冊產品，包括歐洲、加拿大、中國和新興市場。國際擴張是我們 Amneal 關注的關鍵領域。

Moving to operations. Quality remains at the center of everything we do. We make continuous investment in automation, digitization and AI technologies to support quality and advance our global infrastructure. This year, we had several successful FDA inspections at our sites. Amneal's success is grounded in our deep commitment to operational excellence, exceptional customer service, driving efficiencies and maintaining a robust supply chain.

轉向營運。品質仍然是我們所做一切的核心。我們持續投資自動化、數位化和人工智慧技術，以支援品質並推進我們的全球基礎設施。今年，我們的工廠多次成功通過 FDA 檢查。Amneal 的成功源自於我們對卓越營運、卓越客戶服務、提高效率和維護穩健供應鏈的堅定承諾。

Across our supply chain, we are focused on what we call the three Rs; redundancy, resiliency and reliability. We are focused on long-term cost savings by validating secondary sourcing, operational excellence and moving production in-house.

在我們的供應鏈中，我們專注於所謂的「三盧比」；冗餘、彈性和可靠性。我們致力於透過驗證二次採購、卓越營運和內部生產轉移來實現長期成本節約。

In addition, drug shortages remain a challenge for the US supply chain and we are doing our part to address shortages, especially for injectable. We have expanded our injectables manufacturing capacity in recent years to 19 production lines which will allow us to drive long-term growth in injectables.

此外，藥品短缺仍然是美國供應鏈面臨的挑戰，我們正在盡自己的一份力量來解決短缺問題，特別是注射劑的短缺。近年來，我們已將注射劑生產能力擴大至 19 條生產線，這將使我們能夠推動注射劑的長期成長。

Overall, Amneal is expanding and growing in the key areas of medicine, specialty brands, biosimilars, injectables, complex generics, international and distribution. We are so deeply passionate about our company's mission and purpose and the good work that remain ahead. Amneal is part of the solution in addressing several of the critical healthcare challenges in the US today.

總體而言，Amneal 正在醫藥、專業品牌、生物相似藥、注射、複雜仿製藥、國際和分銷等關鍵領域擴張和發展。我們對公司的使命和目標以及未來的出色工作充滿熱情。Amneal 是解決當今美國多項關鍵醫療保健挑戰的解決方案的一部分。

I will now pass it over to Tasos.

現在我將把它交給塔索斯。

Thank you, Chintu. I'll start with our strong second quarter results, then move to our first half and then discuss our higher 2024 guidance expectations.

謝謝你，欽圖。我將從我們強勁的第二季業績開始，然後轉向上半年，然後討論我們更高的 2024 年指導預期。

Five months ago during our March 1 earnings call, we outlined how our growth will meaningfully accelerate in 2024. We laid out an array of growth drivers, including biosimilars, new products, our specialty portfolio, continued AvKARE expansion and strong execution across our business.

五個月前，在 3 月 1 日的財報電話會議上，我們概述了 2024 年我們將如何大幅加速成長。我們制定了一系列成長動力，包括生物相似藥、新產品、我們的專業產品組合、持續的 AvKARE 擴張以及整個業務的強大執行力。

What we said we would do, we are doing. With strong momentum across our diversified business, we're driving accelerated top and bottom-line growth and continuing reducing our debt levels.

我們說過要做的，我們正在做。憑藉我們多元化業務的強勁勢頭，我們正在推動營收和利潤的加速成長，並繼續降低債務水平。

Let me now turn to our second quarter results. Q2 revenues of $702 million grew 17% with growth across our three business segments. Q2 Generics net revenue of $427 million grew 14%, driven by our diverse portfolio of complex products.

現在讓我談談我們第二季的業績。隨著我們三個業務部門的成長，第二季營收達到 7.02 億美元，成長 17%。在我們多樣化的複雜產品組合的推動下，第二季仿製藥淨收入成長了 14%，達到 4.27 億美元。

Biosimilars generated $30 million in revenue driven by ALYMSYS. New products launched in 2023 and 2024 added $36 million to Q2 revenue growth. Additionally, our base portfolio continued to perform very well, driven by robust demand for our complex portfolio and our strong execution by our supply chain and commercial teams. We're working incredibly hard to ensure the needs of our partners and patients are being met on a daily basis.

在 ALYMSYS 的推動下，生物相似藥創造了 3000 萬美元的收入。2023 年和 2024 年推出的新產品為第二季營收成長增加了 3,600 萬美元。此外，由於對我們複雜產品組合的強勁需求以及供應鏈和商業團隊的強大執行力，我們的基礎產品組合繼續表現出色。我們正在非常努力地確保每天滿足我們的合作夥伴和患者的需求。

Our second quarter specialty net revenue of $104 million grew 7% driven by our key branded products, including the recent addition of ONGENTYS. Q2 AvKARE net revenue of $170 million grew 33%, reflecting continued strong growth across all three sales channels.

在我們的主要品牌產品（包括最近新增的 ONGENTYS）的推動下，我們第二季的特種產品淨收入達到 1.04 億美元，成長了 7%。第二季 AvKARE 淨收入為 1.7 億美元，成長 33%，反映出所有三個銷售管道的持續強勁成長。

Our overall second quarter adjusted gross margins of 41% continue to be very robust and in line with expectations. Our second quarter adjusted EBITDA of $162 million grew 11%, reflecting robust revenue growth and operating expense leverage. Our second quarter adjusted EPS of $0.16 declined $0.03 as higher EBITDA was offset by interest expense and higher sales outstanding.

我們第二季的整體調整後毛利率為 41%，仍然非常強勁，符合預期。第二季調整後 EBITDA 為 1.62 億美元，成長 11%，反映出強勁的營收成長和營運費用槓桿。我們第二季調整後每股收益為 0.16 美元，下降了 0.03 美元，因為較高的 EBITDA 被利息支出和較高的未償銷售收入所抵銷。

Looking at our first half financial performance, total company revenues grew 18%, with double-digit revenue growth across all three segments: generics, up 14%; specialty, up 11%; and AvKARE, up 33%. Our first half adjusted EBITDA of $315 million is up 20% year-over-year.

從我們上半年的財務表現來看，公司總收入成長了 18%，所有三個細分市場的收入均達到兩位數成長：仿製藥成長 14%；專業，上漲11%；和 AvKARE，上漲 33%。我們上半年調整後的 EBITDA 為 3.15 億美元，年增 20%。

With continued broad-based strength across our business and operating expense leverage, we are pleased to raise our full year 2024 guidance. We now expect 2024 full year net revenue between $2.7 billion and $2.8 billion, up about $150 million from prior guidance, which reflects 13% to 17% year-over-year growth.

憑藉我們業務和營運費用槓桿的持續廣泛實力，我們很高興上調 2024 年全年指引。我們目前預計 2024 年全年淨收入在 27 億美元至 28 億美元之間，比先前的指導增加約 1.5 億美元，年增 13% 至 17%。

Due to higher revenues, we now expect 2024 adjusted EBITDA of $610 million to $630 million, up from $580 million to $620 million which reflects 9% to 13% year-over-year growth. We expect 2024 adjusted EPS between $0.57 and $0.63, up from $0.53 to $0.63 in prior guidance.

由於營收增加，我們目前預計 2024 年調整後 EBITDA 為 6.1 億美元至 6.3 億美元，高於 5.8 億美元至 6.2 億美元，年增 9% 至 13%。我們預計 2024 年調整後每股盈餘將在 0.57 美元至 0.63 美元之間，高於先前指引的 0.53 美元至 0.63 美元。

Our increased 2024 guidance reflects the ongoing strong performance and momentum across our businesses, continued investments in R&D as we grow our biosimilars pipeline and our commercialization efforts around the upcoming CREXONT launch.

我們上調的 2024 年指引反映了我們各業務持續強勁的業績和勢頭、隨著我們生物仿製藥管道的發展而對研發的持續投資以及圍繞即將推出的 CREXONT 的商業化努力。

The addition of CREXONT is an important new catalyst that bolsters our long-term top and bottom-line growth profile. Combined with the array of growth drivers we have highlighted today and those not yet disclosed, we're confident in our ability to drive sustainable long-term top and bottom-line growth.

CREXONT 的加入是一個重要的新催化劑，可以增強我們的長期頂線和底線成長狀況。結合我們今天強調的和尚未披露的一系列成長動力，我們對推動可持續的長期營收和利潤成長的能力充滿信心。

Let me now turn to our cash and our balance sheet, where our strong financial performance is translating into higher cash generation and deleveraging with our key pillars of value creation. We now expect higher operating cash flow of $280 million to $320 million in 2024, up $20 million from prior guidance, excluding legal settlements.

現在讓我談談我們的現金和資產負債表，我們強勁的財務表現正在轉化為更高的現金產生和去槓桿化，以及我們價值創造的關鍵支柱。我們現在預計 2024 年營運現金流將增加 2.8 億至 3.2 億美元，比先前的指導增加 2,000 萬美元（不包括法律和解）。

Also, we continue to steadily reduce debt as net leverage has decreased from 7.4 times in 2019 to 4.4 times in the second quarter. We plan to pay down over $100 million in debt in the second half of 2024, including $40 million already paid down in July. We expect to reduce net leverage to about 4 times by the end of this year, on our way to below 3 times over the next few years.

此外，我們繼續穩定減少債務，淨槓桿率已從 2019 年的 7.4 倍下降至第二季的 4.4 倍。我們計劃在 2024 年下半年償還超過 1 億美元的債務，其中 7 月已償還的 4,000 萬美元。我們預計到今年年底將淨槓桿率降至 4 倍左右，並在未來幾年內降至 3 倍以下。

I will now turn the call back to Chirag.

我現在會把電話轉回奇拉格。

Thank you, Tasos. Q2 was an outstanding quarter on many fronts as we achieved strong performance and raised our full year outlook. With the approval of CREXONT, we expect the momentum to continue building with additional catalysts on the horizon. As we look forward, we are excited for the opportunities ahead to increase access to high-quality, affordable medicines, improve lives and create value for our shareholders.

謝謝你，塔索斯。第二季度在許多方面都是一個出色的季度，因為我們取得了強勁的業績並提高了全年預期。隨著 CREXONT 的批准，我們預計這一勢頭將繼續增強，並出現更多催化劑。展望未來，我們對未來有機會增加獲得高品質、負擔得起的藥品、改善生活並為股東創造價值的機會感到興奮。

Let's now open the call for Q&A.

現在讓我們開始問答環節。

(Operator Instructions) David Amsellem, Piper Sandler.

（操作說明）David Amsellem、Piper Sandler。

Just a couple for me. First on CREXONT. Can you talk about how you see the payer landscape evolving, particularly Part D, just given the eventual loss of exclusivity for Rytary? So just help us understand what you think access will look like, how restrictive do you think the landscape could be with Rytary being available as a generic. So that's number one.

對我來說只是一對。首先是 CREXONT。鑑於 Rytary 最終失去獨家經營權，您能否談談您如何看待付款人格局的演變，特別是 D 部分？因此，請幫助我們了解您認為訪問會是什麼樣子，您認為 Rytary 作為通用藥物可能會受到多大的限制。所以這是第一。

Then number two, just wanted to pick your brain on complex generics, particularly interested in what you're thinking regarding GLP-1 generics. I think you called out an exenatide pen in your slides. Are there others, the obvious suspects here, that you're looking to file on down the road? I wanted to get your thoughts there.

第二，只是想了解您對複雜仿製藥的看法，特別是對您對 GLP-1 仿製藥的想法感興趣。我想您在幻燈片中提到了艾塞那肽筆。是否還有其他人，即這裡明顯的嫌疑人，是您想要追蹤的？我想了解你的想法。

Thanks, David. So as you know, Rytary has the highest coverage among the Parkinson's products, and we expect similar coverage for CREXONT or even better. And initial discussions with all the payers have been good. We have a very smart strategy on the pricing to make -- as you know, we're going after almost 30% of the market share.

謝謝，大衛。如您所知，Rytary 在帕金森氏症產品中具有最高的覆蓋率，我們預計 CREXONT 的覆蓋率與此類似，甚至更好。與所有付款人的初步討論進展順利。我們在定價方面製定了非常明智的策略——如您所知，我們正在追求近 30% 的市場份額。

Therefore, we have devised a great pricing plan where it's more affordable for seniors, especially the Part D. And with the new Part D out-of-pocket, we expect the adoption for this product and the coverage would be even better. And the fulfillment of prescriptions will be better than previously. We used to lose 20% to 30% prescriptions due to coverage or due to donut hole; we expect that to be much better going forward.

因此，我們設計了一個很棒的定價計劃，讓老年人更能負擔得起，尤其是 D 部分。而且處方的履行會比以前更好。我們曾經因為承保範圍或甜甜圈洞而損失了 20% 到 30% 的處方；我們預計未來會更好。

Joe, do you want to add anything?

喬，你想補充什麼嗎？

Sure. Dave, thanks for the question. The only thing I would add from what Chirag said is that remember, too, we've been in this market now for over a decade. So we've developed very, very good expertise in contracting with the payers. So we're intending to leverage that.

當然。戴夫，謝謝你的提問。奇拉格所說的我唯一要補充的是，請記住，我們已經進入這個市場十多年了。因此，我們在與付款人簽訂合約方面累積了非常非常好的專業知識。所以我們打算利用這一點。

And to Chirag's point, we're also going to be building a pretty comprehensive patient support program to ensure reimbursement and patients actually get on paid therapy, to Chirag's point. So the experience that we've leveraged with Rytary really enables us to ensure access for CREXONT.

對於奇拉格來說，我們還將建立一個相當全面的患者支持計劃，以確保報銷和患者真正獲得付費治療。因此，我們利用 Rytary 的經驗確實使我們能夠確保 CREXONT 的訪問。

And the second one, let me hand it over to my brother, Chintu.

第二個，讓我把它交給我的兄弟 Chintu。

So as you know, Amneal is very focused on a complex product development. And we have spent many years of understanding the entire peptide space and drug/device combination. So we are in a pretty good shape.

如你所知，Amneal 非常專注於複雜的產品開發。我們花了很多年的時間來了解整個勝肽空間和藥物/設備組合。所以我們的狀態非常好。

As you mentioned, exenatide is the -- was the first GLP that was developed by (inaudible) and most likely, we'll be launching that product in the next quarter. That does give us the platform to develop more. We do have other GLPs in pipeline. We have not disclosed which ones. But we do have a deep understanding of API peptides and manufacturing with drug/device combination. So we have a good pipeline in this category of drug.

正如您所提到的，艾塞那肽是（聽不清楚）開發的第一個 GLP，我們很可能會在下個季度推出產品。這確實為我們提供了發展更多的平台。我們確實還有其他 GLP 正在醞釀中。我們還沒有透露是哪些。但我們確實對 API 勝肽以及藥物/設備組合的製造有深入的了解。因此，我們在此類藥物方面擁有良好的管道。

Stay tuned, David.

請繼續關注，大衛。

Les Sulewski, Truist Securities.

Les Sulewski，Truist 證券公司。

Congrats on the approval of CREXONT. Just three questions for me. So maybe first, the focus on CREXONT now that it's approved. I would imagine you have an improved profile across your lenders. Any consideration for a chunky BD plan, further advance your specialty portfolio? Or does the focus remain on internal pipeline with some tuck-ins along the way?

恭喜CREXONT核准。只要問我三個問題。因此，也許首先，既然 CREXONT 已獲得批准，那麼請專注於它。我想您在貸方中的形象會有所改善。是否考慮制定一個厚實的 BD 計劃，進一步推進您的專業投資組合？還是重點仍然放在內部管道上，並在過程中進行一些調整？

Second question is on residual investments in CapEx, I believe you maintained $60 million to $70 million of guidance. I'm just kind of wondering how that second half of the year plans out and then also 2025.

第二個問題是關於資本支出的剩餘投資，我相信您維持了 6,000 萬至 7,000 萬美元的指導。我只是想知道下半年以及 2025 年的計劃如何。

And then third, on the DHE auto-injector launch, I believe that was initially expected in kind of the earlier first half of next year. What's triggering the delay into the second quarter?

第三，關於 DHE 自動注射器的推出，我相信最初預計會在明年上半年早些時候推出。是什麼導致第二季延後？

So we are steadfastly focused on getting to 3 times, as Tasos mentioned, on a leverage profile. Until then, expect us to keep doing the R&D deals and those are really good for us. We do have a large budget of R&D. And as my brother mentioned that we -- internally for Gx now, the spend has gone down. It's still a good amount of spend but not as what it used to be in 2016, '17, '18, '19, right?

因此，正如 Tasos 所提到的，我們堅定不移地致力於將槓桿率提高到 3 倍。在那之前，期望我們繼續進行研發交易，這對我們來說確實有好處。我們確實有大量的研發預算。正如我兄弟所提到的，我們現在在 Gx 內部，支出已經下降。這仍然是一筆不錯的支出，但不像 2016 年、'17、'18、'19 那樣，對吧？

So we have more dollars available for R&D deals and we may acquire some of the commercial assets in the areas we operate, all on the branded side. So that will remain as a BD plan. And then obviously, we'll be -- after we get to 3 times, we will be very engaged in very smart business developments and acquisitions as we have -- our intention is to keep growing Amneal to the next level and next level. We have one of the best team to do that and one of the best foundations in the industry. So we'll expect us to keep doing good business development over time.

因此，我們有更多的資金可用於研發交易，我們可能會收購我們經營領域的一些商業資產，所有這些都在品牌方面。因此，這仍將作為 BD 計劃。顯然，在達到 3 倍之後，我們將像我們一樣積極參與非常明智的業務開發和收購，我們的目的是讓 Amneal 不斷發展到一個新的水平。我們擁有做到這一點的最佳團隊之一，以及業內最好的基金會之一。因此，我們希望隨著時間的推移，我們能夠繼續取得良好的業務發展。

Your second question on CapEx. CapEx will go up from next year and we'll share that detail. This year is in line. As we plan to expand, there's certain specific areas which we'll share information when we have it. DHE auto-injector has always been a first half launch, and which allows us to -- specialty team to focus on CREXONT. And we're completing stability in the fourth quarter. It's our own site. So we don't expect any delays anymore. And after that, PAS, so four to six months after that.

關於資本支出的第二個問題。資本支出將從明年開始增加，我們將分享這個細節。今年已經排到了。當我們計劃擴展時，我們將在某些特定領域分享資訊。DHE 自動注射器一直是上半年推出的，這使我們的專業團隊能夠專注於 CREXONT。我們將在第四季實現穩定。這是我們自己的網站。所以我們預計不會再有任何延誤。在那之後，伊黨，四到六個月後。

We expect approval sometime in April, May.

我們預計在四月、五月的某個時候獲得批准。

Yes. So April, May, we'll be launching it.

是的。所以四月、五月，我們將推出它。

Chris Schott, JPMorgan.

克里斯‧肖特，摩根大通。

This is [Katerina] on for Chris. So just two, if I may. So first, just on biosimilar Prolia and XGEVA, can you talk about your expectations for those markets? And are you expecting similar dynamics to what we saw with HUMIRA and kind of any learnings from how that market is evolving over time in terms of the contracting in the PBM stuff?

這是克里斯的[卡特琳娜]。如果可以的話，就只有兩個。首先，就生物相似藥 Prolia 和 XGEVA 而言，您能談談您對這些市場的期望嗎？您是否期待與我們在 HUMIRA 上看到的類似的動態，以及從該市場如何隨著時間的推移在 PBM 方面的合約演變中學到任何東西？

And then, the second question is just on generic pricing. Can you just talk a little bit more about the broader environment? I think you've touched upon this in the prepared remarks but just what you're seeing in terms of shortages and just the general pricing environment and anything that's kind of changing or something that you're kind of calling out or paying attention to.

然後，第二個問題只是關於通用定價。您能多談談更廣大的環境嗎？我認為您在準備好的發言中已經談到了這一點，但只是您所看到的短缺、整體定價環境以及任何正在發生的變化或您呼籲或關注的事情。

Thank you, Katerina. So Prolia and XGEVA, it touches both markets, the PBM as well as buy and bill and we have expertise in both commercial segment as we have been working with buying groups over the last 20 years, great relationship with them. And so these are similar buying groups have been formed for biosimilar products and we expect to have a fantastic relationship with them. Just like we are ranked top of the line today with our retail buying groups, we'll have the similar relationship.

謝謝你，卡特琳娜。Prolia 和 XGEVA 涉及兩個市場：PBM 以及採購和帳單，我們在這兩個商業領域都擁有專業知識，因為我們在過去 20 年裡一直與採購集團合作，與他們建立了良好的關係。因此，這些類似的生物相似藥購買團體已經形成，我們希望與他們建立良好的關係。就像我們今天在零售採購團體中名列前茅一樣，我們也將擁有類似的關係。

So we expect -- we like that what happened with HUMIRA as aggressively and we knew this would happen. Eventually, the biosimilars will gain 80% or so market share because it's designed to do that. So we are not worried about market penetration for both products.

所以我們預計——我們喜歡 HUMIRA 所發生的事情，我們知道這會發生。最終，生物相似藥將獲得 80% 左右的市場份額，因為它就是為此而設計的。因此，我們並不擔心這兩種產品的市場滲透率。

And if HUMIRA lessens, where -- multiple lessens, right, you -- and which is kind of stabilize the industry as well as you have less competition developing biosimilars than what it used to be. And it's more of a play for companies like us, Teva, Sandoz which are focused on biosimilars, where we already have experience providing affordable medicines.

如果修美樂（HUMIRA）減少，那麼——多重減少，對吧，你——這會穩定該行業，並且開發生物仿製藥的競爭比以前更少。對於像我們、Teva、Sandoz 這樣專注於生物相似藥的公司來說，這更像是一種遊戲，我們已經擁有提供負擔得起的藥物的經驗。

And your second question on Gx pricing, it's better than before. It was unsustainable in 2016, '17, '18, '19, '20, painful years. And manufacturers cannot just keep lowering prices. We have obligations to patients. We have obligations to quality systems. We have obligations to the government of United States as well.

關於 Gx 定價的第二個問題，它比以前更好了。2016 年、17 年、18 年、19 年、20 年是痛苦的幾年，這是不可持續的。製造商不能只是不斷降低價格。我們對患者負有義務。我們對品質體系負有義務。我們也對美國政府負有義務。

So we just -- this is an essential industry. It fills 92% of prescriptions. It is much needed. It has to be sustainable and it's a robust industry. I don't know why you would -- somewhere we would sell our Gx business. When you think about it, what we are doing -- and part of Gx now is injectables, biosimilars, so this -- it's a critical industry and I hope we start getting respect that we deserve and pricing that we deserve.

所以我們只是──這是一個重要的產業。它滿足 92% 的處方需求。這是非常需要的。它必須是可持續的，並且是一個強大的行業。我不知道你為什麼會——我們會在某個地方出售我們的 Gx 業務。當你想到這一點時，我們正在做的事情——Gx現在的一部分是注射、生物仿製藥，所以這是一個關鍵行業，我希望我們開始得到我們應得的尊重和我們應得的定價。

Balaji Prasad, Barclays.

巴拉吉·普拉薩德，巴克萊銀行。

This is [Mikaela] for Balaji. So can you talk about how you see your Parkinson's franchise evolve now with CREXONT approved? What will be the pace of ramp-up look like in the next few years? And how do you expect to achieve synergy within the three assets of your Parkinson's franchise? And also, could you comment a little bit on how will CREXONT impact your margin profile next year and over the next three years?

這是巴拉吉的[Mikaela]。那麼，您能否談談隨著 CREXONT 的批准，您如何看待您的帕金森氏症特許經營業務的發展？未來幾年的成長速度會怎樣？您希望如何在帕金森氏症專營權的三項資產中實現協同作用？另外，您能否評論一下 CREXONT 將如何影響您明年和未來三年的利潤狀況？

Thank you. So we're now the leader in Parkinson's. We have ONGENTYS, Rytary and now CREXONT. We look to add more pipeline assets as well as continue to do research in Parkinson's. This is the area we know really well for 10 years and we've been working closely with patients and providers and it's really touching our heart.

謝謝。所以我們現在是帕金森氏症領域的領導者。我們有 ONGENTYS、Rytary，現在還有 CREXONT。我們希望增加更多的管道資產，並繼續對帕金森氏症進行研究。這是我們 10 年來非常了解的領域，我們一直與患者和提供者密切合作，這確實觸動了我們的心。

So it's the -- I think we can do more for this disease state and we will continue to do so. And it's fantastic synergy, right? The COMT inhibitor with -- CD/LD, COMT inhibitor for certain patient increases the levodopa, or it keeps it longer in the brain, so -- which is completely synergistic to market both product, CREXONT and ONGENTYS.

所以我認為我們可以為這種疾病做更多的事情，我們將繼續這樣做。這是奇妙的協同作用，對吧？COMT 抑制劑與CD/LD 結合，COMT 抑制劑對於某些患者會增加左旋多巴，或使其在大腦中保留更長時間，因此，這與市場上的兩種產品CREXONT 和ONGENTYS 完全具有協同作用。

And as we launch more products which are specialty, biosimilars, even the inhalations, our margin profile should improve on the specialty side. It should improve on Gx. And you see the margins -- the AvKARE margins, obviously, is the distribution business, so which are going to be lower. So that's -- when you combine it, total margin will improve.

隨著我們推出更多的特種產品、生物相似藥，甚至吸入劑，我們的利潤狀況應該會在特殊產品方面有所改善。它應該在 Gx 上有所改進。你會看到利潤率——顯然，AvKARE 的利潤率是分銷業務，所以會更低。所以，當你把它們結合起來時，總利潤率將會提高。

We have no further questions. So I'd like to hand back to Chirag Patel for closing remarks.

我們沒有其他問題了。我想請奇拉格·帕特爾（Chirag Patel）致閉幕詞。

Well, thank you very much. We're so excited and we'll continue to deliver great results and really make an impact for patients and providers in the United States and now slowly but surely expanding internationally as well. Thank you, everybody and have a great day.

嗯，非常感謝。我們非常興奮，我們將繼續提供出色的成果，真正為美國的患者和提供者產生影響，現在也在緩慢但肯定地在國際上擴張。謝謝大家，祝您有美好的一天。

Thanks, everyone.

謝謝大家。

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。