Amneal Pharmaceuticals, Inc. (AMRX) 2026 Q2 法說會逐字稿

Good morning, and welcome to the Amneal Pharmaceuticals second quarter 2026 earnings call. I will now turn the call over to Amneal's Head of Investor Relations, Tony DiMeo.

早安，歡迎參加 Amneal Pharmaceuticals 2026 年第二季財報電話會議。現在我將把電話交給 Amneal 投資人關係主管 Tony DiMeo。

Good morning, and thank you for joining Amneal Pharmaceuticals second quarter 2026 earnings call. Today, we issued a press release reporting Q2 results. The earnings press release and presentation are available on the IR page of amneal.com.

早安，感謝各位參加 Amneal Pharmaceuticals 2026 年第二季財報電話會議。今天我們發布新聞稿，報告第二季業績。財報新聞稿與簡報可於 amneal.com 的投資人關係（IR）頁面取得。

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. Please see the sections entitled Cautionary Statements on Forward-Looking Statements in our press release and presentation for factors that may impact future performance.

本次電話會議中，關於非歷史事實之事項所作的某些陳述（包括但不限於管理層的展望或預測）屬於前瞻性陳述，且僅基於我們目前可取得的資訊。請參閱我們新聞稿與簡報中題為「前瞻性陳述之警示聲明」的章節，以了解可能影響未來表現的因素。

We also discuss non-GAAP measures. Information on use of these measures and reconciliation to GAAP are in the earnings release and presentation.

我們也會討論非 GAAP 指標。關於這些指標的使用資訊以及與 GAAP 的調節，均載於財報新聞稿與簡報中。

On the call today are Chirag and Chintu Patel, Co-founders and Co-CEOs; Tasos Konidaris, CFO; Joe Renda for Specialty; and Jason Daly, Chief Legal Officer. I will now hand the call over to Chirag.

今天出席電話會議的有共同創辦人暨共同執行長 Chirag 與 Chintu Patel；財務長（CFO）Tasos Konidaris；負責專科（Specialty）業務的 Joe Renda；以及法務長 Jason Daly。現在我把電話交給 Chirag。

Thank you. Good morning, everyone. Amneal is in the midst of the most transformative period in our company's history. We are growing as one of the America's leading affordable medicines businesses with an increasingly diversified and high-impact medicines portfolio, including Specialty brands, biosimilars, GLP-1s, and complex generics across dosage forms such as transdermals and injectables.

謝謝。各位早安。Amneal 正處於公司史上最具轉型意義的時期。我們正成長為美國領先的平價藥品企業之一，並持續擴大且高影響力的藥品組合多元化，涵蓋專科品牌、生物相似藥、GLP-1，以及跨多種劑型（如經皮貼片與注射劑）的複雜學名藥。

As we execute our strategy, we're building a larger, more impactful Amneal. That continued momentum is reflected in our second quarter results, where the company delivered revenue of $796 million, adjusted EBITDA of $206 million, and adjusted EPS of $0.30. At the halfway point of the year, we're pleased to once again raise our 2026 outlook.

在執行策略的同時，我們正在打造規模更大、影響力更強的 Amneal。這股持續動能反映在我們第二季的業績中：公司營收 7.96 億美元，調整後 EBITDA 為 2.06 億美元，調整後每股盈餘（EPS）為 0.30 美元。年度過半之際，我們很高興再次上調 2026 年展望。

This year reflects our seventh consecutive year of top and bottom-line growth. As a purpose-driven company, we have a tremendous opportunity to help the next era of affordable medicines here in the United States and globally by expanding access for patients and providers. While Amneal has always been growth-oriented, the scale of the opportunity in front of us today has never been greater. With that, let me touch on key growth opportunities.

今年是我們連續第七年在營收與獲利（上、下線）皆實現成長。作為一家以使命為導向的公司，我們有極大的機會在美國及全球透過擴大病患與醫療提供者的可近性，協助推動下一個平價藥品時代。雖然 Amneal 一向以成長為導向，但我們眼前的機會規模從未如此之大。接下來我將談談幾項關鍵成長機會。

First, in affordable medicines, our base business remains strong, resilient, and growing, with highly relevant and in-demand therapies. In women's health, demand for transdermal patches increased following the revised FDA guidance late last year. We are increasing our capacity. Looking forward, our pipeline remains focused on high-value opportunities such as lanreotide, where complexity, reliable supply, customer relationship, and executions are key.

第一，在平價藥品方面，我們的核心業務依然強勁、具韌性且持續成長，所提供的治療領域高度相關且需求旺盛。在女性健康領域，去年底 FDA 修訂指引後，對經皮貼片的需求增加。我們正在提升產能。展望未來，我們的產品線仍聚焦於如 lanreotide 等高價值機會，其中複雜度、穩定供應、客戶關係與執行力是關鍵。

Second, in biosimilars, we're building a new large growth platform for Amneal. With the pending acquisition of Kashiv, we would become a fully integrated global biosimilar player from development to commercial supply. The timing is incredibly compelling. The US biosimilars market is entering a major growth cycle driven by an unprecedented wave of biologics losing exclusivity, streamlined regulatory pathways, attractive commercial structures emerging, including private labels, and accelerating market adoption.

第二，在生物相似藥方面，我們正在為 Amneal 打造一個新的大型成長平台。隨著 Kashiv 併購案即將完成，我們將成為從研發到商業供應皆一體化的全球生物相似藥業者。時機極具吸引力。美國生物相似藥市場正進入主要成長週期，驅動因素包括前所未有的大量生物製劑專利/獨占到期、法規途徑簡化、具吸引力的商業結構（包含自有品牌 private label）逐步成形，以及市場採用加速。

Over the next decade, 118 biologics are expected to lose exclusivity in the United States alone, with relatively limited development expected for most molecules. Accordingly, we see a broad set of biosimilar opportunities with limited competition that can support reliable and repeatable value creation.

未來十年，僅在美國就預計有 118 項生物製劑將失去獨占權，而多數分子預期開發投入相對有限。因此，我們看見一系列競爭有限的生物相似藥機會，可支持穩健且可重複的價值創造。

Amneal is well positioned to capitalize on these opportunities. Approximately 75% of our biosimilar portfolio will be focused on targeted lower competition, while 25% will address larger market opportunities. That mix gives us significant growth potential and meaningful upside.

Amneal 已具備良好條件把握這些機會。我們的生物相似藥產品組合約 75% 將聚焦於競爭較低的標的，另有 25% 將鎖定更大的市場機會。這樣的組合使我們具備顯著的成長潛力與可觀的上行空間。

Biosimilars align with our commercial strength as well. Through private label and customer relationship, we can bring products to market efficiently, leveraging our leading US retail and institutional presence, channel access, and scale. This is a natural extension of our affordable medicines strategy. Overall, biosimilars are the next major growth area for Amneal and fit directly in our mission: expanding access, providing affordability, and building a durable long-term growth platform.

生物相似藥也與我們的商業優勢相契合。透過自有品牌與客戶關係，我們能有效率地將產品推向市場，並運用我們在美國零售與機構通路的領先布局、通路准入與規模優勢。這是我們平價藥品策略的自然延伸。整體而言，生物相似藥是 Amneal 下一個主要成長領域，並直接契合我們的使命：擴大可近性、提供可負擔性，並建立具韌性的長期成長平台。

Third, in specialty, we have a differentiated branded product portfolio. CREXONT continues to gain traction, and recent phase IV data reinforces its potential to become a first-line treatment option for Parkinson's patient. Also, Brekiya continues to see very strong uptake in its first several quarters on the market, as it addresses an important unmet need for migraine and cluster headache sufferers.

第三，在專科領域，我們擁有具差異化的品牌產品組合。CREXONT 持續獲得市場動能，近期第四期臨床數據也強化其成為帕金森氏症患者第一線治療選項的潛力。此外，Brekiya 在上市後的前幾個季度持續呈現非常強勁的採用成長，因其滿足偏頭痛與叢集性頭痛患者的重要未被滿足需求。

Fourth, in distribution, AvKARE continues to provide diversification and access to important government and institutional channels, representing a meaningful opportunity to grow this business over time.

第四，在配送/分銷方面，AvKARE 持續帶來業務多元化，並提供進入重要政府與機構通路的機會，長期而言代表此業務具備可觀的成長機會。

In summary, we are incredibly excited about the ongoing strategic evolution of Amneal, highly confident in our ability to sustain this momentum going forward. I'll now turn it over to Chintu.

總結來說，我們對 Amneal 持續的策略演進感到非常振奮，並對未來維持這股動能的能力充滿信心。現在我把電話交給 Chintu。

Thank you, Chirag, and good morning, everyone. I would like to thank our Amneal team for another quarter of very strong execution. Our team continues to deliver across operations, quality, supply chain, R&D, commercial execution, and customer service. This consistency allows us to grow while also building towards the next generation of opportunities, such as specialty, biosimilars, and GLP-1s. Let me begin with an update on one of our manufacturing sites in India.

謝謝你，Chirag，各位早安。我要感謝 Amneal 團隊在本季再次展現非常強勁的執行力。我們的團隊在營運、品質、供應鏈、研發、商業執行與客戶服務等方面持續交出成果。這樣的一致性讓我們在成長的同時，也能為下一代機會奠基，例如專科、生物相似藥與 GLP-1。我先從印度其中一座製造據點的最新情況談起。

One week ago, the Gujarat region experienced a severe rainfall and flooding, which impacted one of our facilities in India. Most importantly, all Amneal employees are safe and accounted for. We expect a limited impact on a select number of products. We look to resume operation within the next few weeks.

一週前，古吉拉特地區遭遇嚴重降雨與洪水，影響了我們在印度的一處設施。最重要的是，所有 Amneal 員工皆安全且已確認無虞。我們預期僅會對少數特定產品造成有限影響。我們預計在未來幾週內恢復營運。

I will provide an update on three areas. First, the strength of our operating platform. Second, the strategic fit and capabilities Kashiv brings in biosimilar. Third, the continued momentum across our pipeline.

我將就三個面向提供更新。第一，我們營運平台的強勁表現。第二，Kashiv 在生物相似藥方面帶來的策略契合度與能力。第三，我們產品線持續推進的動能。

First, in operation, our global high-quality manufacturing and supply chain capabilities remain a core competitive advantage. If you walk into an Amneal facility today, it looks remarkably different than just several years ago. Through digitization, automation, and deploying AI tools in different areas, we are unveiling our next generation of manufacturing and quality, while also driving continued efficiencies.

第一，在營運方面，我們全球高品質的製造與供應鏈能力仍是核心競爭優勢。如果你今天走進 Amneal 的一座工廠，會發現它與幾年前相比已截然不同。透過數位化、自動化，以及在不同領域部署 AI 工具，我們正揭示下一代製造與品質體系，同時持續提升效率。

Strategically, we have built a broad operational network with deep expertise across dosage forms. This matters more than ever. Patients, providers, and all stakeholders of the healthcare system are focused on the quality, reliability, and resiliency of the pharmaceutical supply chain. We are excited to expand our capabilities and capacity in complex dosage forms, including transdermals, sterile injectables, and long-acting depots, enabling Amneal to increase our volumes and drive very meaningful near-term growth.

在策略上，我們已建立廣泛的營運網絡，並在各種劑型方面具備深厚專業能力。這一點比以往任何時候都更重要。病患、醫療服務提供者以及醫療體系的所有利害關係人，都聚焦於藥品供應鏈的品質、可靠性與韌性。我們很高興擴大在複雜劑型方面的能力與產能，包括經皮貼片、無菌注射劑與長效緩釋製劑（depot），使 Amneal 能夠提升出貨量並推動極具意義的短期成長。

Our scale, leading US manufacturing footprint, and strong technical capabilities positions us to deliver reliable, high-quality supply while addressing important market needs and drug shortages. To that point, we are pleased to share that Amneal's Brookhaven, N.Y. site was recently selected as one of only seven companies in the FDA's PreCheck pilot program, alongside other leading companies such as Eli Lilly and Regeneron.

我們的規模、領先的美國製造版圖以及強大的技術能力，使我們能在滿足重要市場需求與藥品短缺問題的同時，提供可靠且高品質的供應。就此而言，我們很高興分享：Amneal 位於紐約州布魯克黑文（Brookhaven, N.Y.）的廠區，近期獲選為 FDA PreCheck 試點計畫中僅有的七家公司之一，與禮來（Eli Lilly）與再生元（Regeneron）等其他領先公司並列。

The program is intended to advance US drug manufacturing and strengthen supply chain resiliency by allowing earlier FDA engagement on facility readiness and support access to critical medicine. For Amneal, it is an important recognition of our robust US manufacturing, particularly as we expand into sterile injectable manufacturing here in the US over the next few years.

該計畫旨在透過讓 FDA 更早介入評估設施就緒度，推動美國藥品製造並強化供應鏈韌性，同時支持關鍵藥品的可近性。對 Amneal 而言，這是對我們強健美國製造能力的重要肯定，尤其是在未來幾年我們將於美國擴展無菌注射劑製造之際。

Second, we are very excited about the Kashiv acquisition, which will add the in-house biologics capabilities we need to succeed in biosimilars. The end-to-end capabilities will span cell line and clone development, protein characterization, process development, clinical execution, regulatory expertise, and scaled biologics manufacturing in India and US.

第二，我們對收購 Kashiv 感到非常振奮，這將補足我們在生物相似藥領域成功所需的內部生物製劑能力。端到端能力將涵蓋細胞株與克隆開發、蛋白質特性分析、製程開發、臨床執行、法規專業，以及在印度與美國的規模化生物製劑製造。

Kashiv is a biologics platform built over one decade with deep scientific expertise across monoclonal antibodies, fusion proteins, cytokines, microbial products, and other complex modalities. Kashiv's drug substance capacity is expected to expand from approximately 26,000 liters by the end of 2026 to approximately 75,000 liters by 2028. With Kashiv, we will be able to do it all in biologics. Kashiv brings the science, development, and manufacturing engine, and Amneal brings the US commercial engine with our leading retail position and channel expertise.

Kashiv 是一個歷經十年打造的生物製劑平台，在單株抗體、融合蛋白、細胞激素、微生物產品及其他複雜模態方面具備深厚科學專長。Kashiv 的原料藥（drug substance）產能預計將由 2026 年底約 26,000 公升擴增至 2028 年約 75,000 公升。有了 Kashiv，我們將能在生物製劑領域做到全方位布局。Kashiv 帶來科學、開發與製造引擎，而 Amneal 則憑藉領先的零售地位與通路專業，帶來美國商業化引擎。

This is a powerful combination. Together, this combined model will allow us to advance multiple molecules at the same time, make smart portfolio decisions, move quickly, and capture more economics across the value chain. With our current and future biosimilar capacity, we are well-positioned to supply a meaningful share at launch with excess capacity to respond to market demand as needed.

這是一個強而有力的組合。透過此一整合模式，我們將能同時推進多個分子項目、做出明智的產品組合決策、快速行動，並在價值鏈各環節取得更多經濟效益。憑藉我們現有與未來的生物相似藥產能，我們具備在上市時供應具相當份額的能力，並保有多餘產能以在需要時回應市場需求。

In addition, the combined pipeline of over 20 biosimilar programs supports a meaningful number of new launches over time. We are very excited about upcoming biosimilar opportunities for Xolair, Orencia, Cimzia and Stelara, which are attractive molecules with significant market potential and relatively limited competition. We believe each has the potential to become a meaningful growth driver. Longer term, the pipeline extends well into the 2030s, providing substantial runway for growth.

此外，合併後超過 20 項生物相似藥計畫的研發管線，將在時間推移中支持相當數量的新產品上市。我們對 Xolair、Orencia、Cimzia 與 Stelara 的即將到來之生物相似藥機會感到非常振奮；這些都是具吸引力、擁有顯著市場潛力且競爭相對有限的分子。我們相信每一項都有潛力成為重要的成長動能。長期而言，該管線可延伸至 2030 年代，提供充足的成長跑道。

Third, turning to our affordable medicine pipeline. We are in the midst of the most concentrated and impactful wave of high-value new launches in our company's history. Importantly, it is not just the number of launches that matters, it is the value, complexity, and durability of these products.

第三，談到我們的平價藥品研發管線。我們正處於公司史上最集中且最具影響力的一波高價值新產品上市浪潮之中。重要的是，關鍵不僅在於上市數量，更在於這些產品的價值、複雜度與持久性。

This momentum is the result of choices we made many years ago. We deliberately prioritized complex generics and differentiated dosage forms, including injectables, ophthalmics, inhalation products, drug device combinations, 505(b)(2) opportunities, and other non-oral solid dosage forms, where technical complexity and execution create long-term durable value.

這股動能源自我們多年前所做的選擇。我們刻意優先投入複雜學名藥與差異化劑型，包括注射劑、眼科用藥、吸入製劑、藥械組合產品、505(b)(2) 機會，以及其他非口服固體劑型；在這些領域，技術複雜度與執行力能創造長期且可持續的價值。

Our recent approvals and upcoming launches show the strategy is working. This includes the recent approval of romidepsin in oncology, additional strengths of presentation of iohexol, and ready-to-use sodium bicarbonate, our latest 505(b)(2) injectables, along with potential approval of lanreotide in Q3. Each product reflects the high-impact opportunities that we have been building towards and demonstrate the strength of our affordable medicines pipeline.

我們近期的核准與即將上市的產品顯示該策略正在奏效。其中包括近期在腫瘤領域獲核准的 romidepsin、iohexol 的更多規格/濃度呈現，以及即用型碳酸氫鈉（sodium bicarbonate）——我們最新的 505(b)(2) 注射劑——以及第三季可能獲核准的 lanreotide。每一項產品都反映我們長期打造的高影響力機會，並展現我們平價藥品研發管線的實力。

The wheel of innovation continues to turn with another 12-15 high-value complex ANDA filings planned this year, including two more metered dose inhalation products. These opportunities exemplify Amneal's core strengths: strong R&D, complex manufacturing, deep customer relationships, and a track record of reliable supply. We are using the same playbook that built our affordable medicines business and applying it to biosimilars.

創新之輪持續轉動，今年計畫再提交 12–15 項高價值的複雜 ANDA 申請，其中包括另外兩項定量噴霧吸入（metered dose inhalation）產品。這些機會體現 Amneal 的核心優勢：強大的研發能力、複雜製造能力、深厚的客戶關係，以及可靠供應的實績。我們正運用打造平價藥品事業的同一套方法論，並將其應用到生物相似藥領域。

In specialty, we are pleased with the continued strong performance of CREXONT and Brekiya. These successful product launches reflect our ability to develop new medicines, build brands, and bring forward therapies that improve patient care.

在專科領域，我們對 CREXONT 與 Brekiya 持續強勁的表現感到滿意。這些成功的產品上市，反映我們具備開發新藥、建立品牌，並推出可改善病患照護之治療方案的能力。

For CREXONT, the real-world evidence for Parkinson's patients is very compelling. We recently shared data from our first Phase IV open-label study that showed patients converting to CREXONT had three or more hours of good on time per day versus RYTARY and other carbidopa/levodopa therapies, and a meaningful improvement in symptom control. In Q4, we are starting a new Phase IV study looking at the impact of CREXONT on treatment-naïve patients recently diagnosed with PD and disease progression. More broadly, we are building on this specialty foundation with additional R&D pipeline opportunities.

就 CREXONT 而言，針對帕金森氏症病患的真實世界證據非常具說服力。我們近期分享了第一項第四期（Phase IV）開放標籤研究的數據，顯示轉換至 CREXONT 的病患，相較於 RYTARY 及其他 carbidopa/levodopa 治療，每日可多出三小時或以上的良好「開」期（good on time），且症狀控制有顯著改善。在第四季，我們將啟動一項新的第四期研究，評估 CREXONT 對近期確診 PD 的初治（treatment-naïve）病患以及疾病進展的影響。更廣泛而言，我們正以此專科基礎為依託，拓展更多研發管線機會。

While CREXONT and Brekiya are key growth drivers today, they represent the beginning of a broader specialty pipeline that we are advancing, and we look to share more in the future. Taken together, we are well-positioned for continued growth and remain laser-focused on executing across our key operational, commercial, and pipeline opportunities. I will now hand it over to Tasos.

雖然 CREXONT 與 Brekiya 是當前的關鍵成長動能，但它們只是我們正在推進之更廣泛專科研發管線的起點；未來我們也將分享更多進展。綜合而言，我們已為持續成長做好布局，並將高度聚焦於在關鍵營運、商業化與研發管線機會上的執行。接下來我把時間交給 Tasos。

Thank you, Chintu, and good morning, everyone. The second quarter played out as expected, with revenue growth accelerating and broad-based momentum building across our business. Consequently, we are very pleased with our continued strong financial performance and ability to raise our 2026 outlook again this quarter, reflecting the strength and diversification of our business, a number of key growth drivers, and the success of the business model we have strategically built over several years. We expect this momentum to continue through the balance of 2026 and into 2027 and beyond.

謝謝你，Chintu，各位早安。第二季的表現符合預期，營收成長加速，且我們業務各面向的動能持續擴大。因此，我們對持續強勁的財務表現，以及本季再次上調 2026 年展望的能力感到非常滿意；這反映了我們業務的強度與多元化、若干關鍵成長動能，以及我們多年來策略性打造之商業模式的成功。我們預期這股動能將延續至 2026 年剩餘期間，並進一步延伸至 2027 年及更長遠。

For the second quarter, total net revenue was $796 million, up 10%. adjusted EBITDA was $206 million, up 12%, and adjusted EPS was $0.30, up 20%. Our results were driven by strong execution across our three business segments, favorable product mix, and operating expense discipline.

就第二季而言，淨營收總額為 7.96 億美元，成長 10%。調整後 EBITDA 為 2.06 億美元，成長 12%；調整後 EPS 為 0.30 美元，成長 20%。我們的業績來自三大業務部門的強勁執行、有利的產品組合，以及對營運費用的紀律控管。

For the second quarter, affordable medicines delivered revenue of $490 million, up 13%, reflecting the strength of our broad-based complex portfolio, including our women's health products, injectables, and higher naloxone sales. In addition, new product launches added $45 million to second quarter revenue growth, including two recently launched products, one in ophthalmology and one in urology. Our specialty revenue was $149 million, up 17%, driven by continued momentum in CREXONT, Unithroid, and Brekiya, all ahead of expectations.

第二季，平價藥品業務營收為4.90億美元，年增13%，反映我們廣泛的複雜產品組合（包括女性健康產品、注射劑，以及更高的納洛酮銷售）所展現的強勁動能。此外，新產品上市為第二季營收成長貢獻4,500萬美元，其中包括兩項近期上市產品，一項在眼科領域，另一項在泌尿科領域。我們的專科藥品營收為1.49億美元，年增17%，主要由CREXONT、Unithroid與Brekiya的持續成長動能所帶動，且皆優於預期。

Moving on to AvKARE, where second quarter revenue was $157 million, down 4%, similar to the first quarter, as growth in the government channel was offset by the low margin distribution business as we expected. As we have shared in the past, we remain focused on the unique value we provide in the government channel and continue to expand Amneal's profitability.

接著談到AvKARE，第二季營收為1.57億美元，年減4%，與第一季相近；如我們預期，政府通路的成長被低毛利的配送業務所抵銷。如同我們過去分享的，我們仍專注於在政府通路所提供的獨特價值，並持續提升Amneal的獲利能力。

Moving down the P&L, our second quarter adjusted gross margin was strong at 46.2%, up 60 basis points year-over-year, reflecting favorable mix and continued operating efficiencies. Adjusted EBITDA grew 12% due to strong revenue growth, gross margin expansion, and disciplined expense management. From an adjusted EPS perspective, the second quarter grew 20%, reflecting the adjusted EBITDA growth and lower interest expense.

往下看損益表，第二季調整後毛利率表現強勁，達46.2%，年增60個基點，反映有利的產品組合與持續的營運效率提升。調整後EBITDA因營收強勁成長、毛利率擴張及嚴謹的費用管理而成長12%。從調整後EPS角度來看，第二季成長20%，反映調整後EBITDA成長以及利息費用下降。

Let me take a moment to acknowledge the strength of our first half financial performance, with total revenues up 7%, adjusted EBITDA up 16%, and adjusted EPS growth of 27%. Furthermore, I'm pleased to report that we recently repriced our $2.4 billion Term Loan B, due in 2032, and reduced our interest expense by 50 basis points, which equate to $12 million in annual interest expense savings.

我想花點時間肯定我們上半年財務表現的強勁：總營收成長7%，調整後EBITDA成長16%，調整後EPS成長27%。此外，我也很高興報告，我們近期已將2032年到期的24億美元B期定期貸款（Term Loan B）重新定價，並將利息費用降低50個基點，相當於每年節省1,200萬美元的利息支出。

Given the strength of our business, we're very pleased to raise our full year 2026 guidance against this quarter. We're increasing our revenue outlook by $50 million to $3.1 billion to $3.2 billion, with high single-digit growth expected in both specialty and affordable medicines. We're raising our adjusted EBITDA guidance by $10 million, between $750 million and $780 million, reflecting strong revenues and higher gross margin. This guidance includes an estimated $20 million of negative impact anticipated as a result of the recent flood in our India facility, as Chintu mentioned earlier on.

鑑於我們業務的強勁表現，我們很高興在本季上調2026全年財測指引。我們將營收展望上調5,000萬美元至31億至32億美元，預期專科藥品與平價藥品兩大業務皆可達到高個位數成長。我們將調整後EBITDA指引上調1,000萬美元至7.50億至7.80億美元，反映強勁營收與更高毛利率。此指引包含預估約2,000萬美元的負面影響，係因近期印度廠區洪災所致，如Chintu先前所提。

From an EPS perspective, we're increasing our guidance by a penny, between $0.96 and $1.06, due to our higher profitability and lower interest expense following our most recent successful debt repricing. From a CapEx perspective, we're increasing our expectations from about $110 million to $150 million to capitalize on multiple near-term opportunities that we see in the marketplace, such as greater market demand for our women's health products and injectable expansion in the US. Finally, we are maintaining our operating cash flow guidance.

就EPS而言，我們將指引上調0.01美元至0.96至1.06美元，主要因獲利能力提升，以及在最近一次成功的債務重新定價後利息費用下降。就資本支出（CapEx）而言，我們將預期由約1.10億美元提高至1.50億美元，以把握我們在市場上看到的多項近期機會，例如女性健康產品更高的市場需求，以及在美國擴大注射劑產能。最後，我們維持營運現金流指引不變。

Turning to Kashiv for a second, we are entering the transaction from a position of strength, supported by a diverse set of growth drivers, strong cash flow, and disciplined balance sheet management. This progress was further validated in April, when we received a one-notch credit rating upgrade in our most recent successful Term Loan B repricing.

再談Kashiv，我們是在強勢基礎上推進此交易，背後有多元的成長動能、強勁現金流，以及嚴謹的資產負債表管理作為支撐。這項進展也在4月獲得進一步驗證，當時我們在最近一次成功的B期定期貸款重新定價中，信用評等上調一級。

As we have outlined, the Kashiv transaction is compelling both strategically and financially. First, the acquisition enables us to be a leader in the multi-billion dollar global biosimilars market that is growing rapidly. Second, we expect to capture $400 million to $500 million in financial benefits driven by tax and local incentives, as well as eliminating milestone and profit-sharing obligations. Third, we see a clear path to deleveraging, with net leverage below 3x by 2028.

如我們所述，Kashiv交易在策略與財務面皆具吸引力。第一，此收購使我們得以成為快速成長、規模達數十億美元的全球生物相似藥市場的領導者。第二，我們預期可取得4億至5億美元的財務效益，主要來自稅務與在地獎勵措施，以及取消里程碑付款與利潤分成義務。第三，我們看到明確的去槓桿路徑，預計至2028年淨槓桿可降至3倍以下。

We expect the Kashiv transaction to close over the next few weeks, pending shareholder vote tomorrow and satisfaction of closing conditions. With that, I will turn the call back to Chirag.

我們預期Kashiv交易將在未來幾週內完成，仍需待明日股東投票通過並滿足交割條件。接下來我把電話交回給Chirag。

Thank you, Tasos. Our Q2 results demonstrate the strength of Amneal's diversified business and the momentum across our growth platforms. We are delivering strong performance today with more significant opportunities ahead than any point in our company's history. The pending Kashiv acquisition is a natural extension of our strategy that will create a fully integrated global biosimilar platform, provide us access to a very large market opportunity, and establish a major new long-term growth pillar.

謝謝你，Tasos。我們第二季的結果展現Amneal多元化業務的韌性，以及各成長平台的動能。我們目前正交出強勁表現，而未來的重大機會也比公司歷史上任何時點都更為可觀。待完成的Kashiv收購是我們策略的自然延伸，將打造一個完全整合的全球生物相似藥平台，讓我們得以切入非常龐大的市場機會，並建立一個重要的全新長期成長支柱。

We are excited about the future and the substantial value creation ahead. Our goal remains clear: to become America's number one affordable medicines company and a leading global provider of essential medicines, because innovation only matters when it reaches the patient. With that, let's open the call for Q&A.

我們對未來以及即將到來的重大價值創造感到振奮。我們的目標依然明確：成為美國第一的平價藥品公司，以及全球領先的必需藥品供應商，因為創新只有在能觸及病患時才有意義。接下來，我們開放Q&A。

(Operator Instructions) Glen Santangelo, Barclays.

(接線員指示) Glen Santangelo，Barclays。

Just two quick ones from me. Chirag, I think I heard you said you're still expecting the timing for lanreotide to be 3Q, and if memory serves me correct, the biosimilar for Xolair, you're expecting later in the fourth quarter. I'm just kind of curious as to maybe what you have included in the second half fiscal 2026 guide for these launches.

我這邊只有兩個簡短問題。Chirag，我想我聽到你說你們仍預期lanreotide的時程會在第三季；如果我沒記錯，Xolair的生物相似藥則預期在第四季較晚的時點。我有點好奇，你們在2026財年下半年指引中，對這些上市推出已納入了哪些假設？

My second question is really around Kashiv. I think at the time of the deal, you said you're expecting to have six commercial biosimilars in the market by 2027, with a $14 billion TAM. I was just wondering if you could just give us an update on the timing and maybe a little bit more transparency into which launches will be more meaningful here.

第二個問題是關於Kashiv。我記得在交易宣布時，你們提到預期到2027年市場上會有六個商業化的生物相似藥，對應的TAM為140億美元。想請你們更新一下時程，並且能否更透明地說明哪些上市推出在這裡會更具意義？

(inaudible) is on its way. That's what we feel as of today. It has official go date in Q3. We have included some of the forecast number, but not probably the market total.

(聽不清楚)正在推進中。就目前而言，這是我們今天的判斷。它在第三季有正式的啟動日期。我們已納入部分預測數字，但可能沒有把整體市場規模都納入。

Very conservative.

非常保守。

Conservative is included. Xolair is towards very late end of the year or could spill into the January 5th. Nothing is included for Xolair for this year.

已納入的是保守假設。Xolair會在年底非常後段，或可能延到1月5日之後。今年的指引中沒有納入Xolair的任何貢獻。

In Kashiv Biosciences, or your question on the six commercial biosimilars, as you know, we market ALYMSYS, Releuko, Fylnetra. We are launching Prolia and Xgeva and look forward to launch Xolair sometimes next year, hopefully very early. That becomes six biosimilars commercialized by next year and more to follow there on in 2027, 2028, 2029. Very exciting pipeline.

關於Kashiv Biosciences，或你提到的六個商業化生物相似藥，如你所知，我們已在市場上銷售ALYMSYS、Releuko、Fylnetra。我們將推出Prolia與Xgeva，並期待在明年某個時點推出Xolair，希望能非常早。如此一來，到明年將有六個生物相似藥完成商業化，之後在2027、2028、2029年還會有更多產品接續推出。產品線非常令人振奮。

Chris Schott, JPMorgan.

Chris Schott，摩根大通。

This is (inaudible) on for Chris. Just two questions from us. First, just on tariffs, your thoughts on some of these recent headlines from the administration. How should we think about potential impact both for Amneal and the industry, and have there been any discussions between generic manufacturers and the administration since the announcement?

我是（聽不清）代 Chris 提問。我們這邊只有兩個問題。第一個是關於關稅，想聽聽你對政府近期一些新聞標題的看法。我們應該如何看待對 Amneal 以及整個產業的潛在影響？另外，自公告以來，學名藥製造商與政府之間是否有任何討論？

Second question is just on CREXONT. It seems like another very strong quarter for the product. Just any interesting trends you guys are seeing in terms of where uptake is coming from or anything else you're kind of seeing in that market?

第二個問題是關於 CREXONT。看起來這個產品又交出非常強勁的一季。你們是否看到任何有趣的趨勢，例如採用（uptake）主要來自哪些來源，或是你們在該市場中觀察到的其他現象？

As you know, Amneal has a very vast manufacturing network in the United States. We always look and also expanding our capacity in the United States in sterile and patches as well. As far as the recent announcement, we look forward for more information and would collaborate with administration as we move forward.

如你所知，Amneal 在美國擁有非常龐大的製造網絡。我們也一直在評估並擴增我們在美國的產能，包括無菌製劑與貼片等。就近期的公告而言，我們期待獲得更多資訊，並將在後續推進過程中與政府合作。

Your second question on CREXONT, we're seeing 80% of the scripts coming from general neuro, which wasn't the case for RYTARY, and that continues to happen. As you know, 80% of prescription are written by the general neurologist, so very exciting. The Phase IV data is exciting as well, well-received, and the script trend is keep going up every week. And it's truly a needed therapy for the Parkinson's patient, and our goal will be to make that a first-line therapy to replace the immediate-release product

關於你第二個有關 CREXONT 的問題，我們看到 80% 的處方來自一般神經科醫師，這在 RYTARY 時期並非如此，而這個趨勢仍在持續。如你所知，80% 的處方是由一般神經科醫師開立，因此非常令人振奮。第四期（Phase IV）數據也令人振奮、反應良好，而處方趨勢每週都在上升。這確實是帕金森氏症患者所需要的治療，我們的目標是讓它成為第一線治療，以取代速放型（immediate-release）產品

David Amsellem, Piper Sandler.

David Amsellem，Piper Sandler。

Couple from me, first on iohexol with the additional SKUs approved, can you talk about how big of an opportunity that could be, not just this year, but also in '27, if you can quantify that and your views on how long that could be a situation where there's limited competition?

我有幾個問題。首先關於 iohexol，隨著額外 SKU 獲批，你能談談這可能帶來多大的機會嗎？不僅是今年，也包括 2027 年；如果可以的話，請量化一下。另外，你對於這種競爭有限的情況可能會持續多久，有何看法？

A similar question on lanreotide. Can you just level set for us to the extent you get approved, how long that could be a limited competition situation? Lastly, on your specialty business and particularly neurology, what's your appetite for adding assets where you can leverage your existing commercial infrastructure in neuro?

關於 lanreotide 也有類似的問題。如果你們獲批，能否幫我們校準一下：競爭有限的情況可能會持續多久？最後，關於你們的專科業務，特別是神經科領域，你們對於新增資產、並能利用既有神經科商業化基礎設施的意願有多大？

Iohexol is a very complex product, and it requires very good supply chain control and a manufacturing footprint. We are very excited with the new SKUs that are getting approved. We are expecting other one or two more strengths to get approved by end of the year. I think going into next year, we'll complete the entire basket because it has multiple strengths.

Iohexol 是一個非常複雜的產品，需要非常良好的供應鏈控管與製造佈局。我們對於新獲批的 SKU 感到非常興奮。我們預期在今年年底前，還會有另外一到兩個規格（strength）獲批。我認為進入明年，我們將完成整個產品組合，因為它有多種規格。

Same times, we have increased our capacity this year, and we look forward to capitalize on the full market potential next year. From quantification perspective, we think this is a $50 plus million opportunity, maybe more going forward, and we have secured a very good supply chain.

同時，我們今年已提高產能，並期待在明年把握完整的市場潛力。就量化而言，我們認為這是一個 5,000 萬美元以上的機會，未來可能更高，而且我們已建立非常穩健的供應鏈。

Regarding lanreotide, it's the same thing. It's a very complex manufacturing. As you know, it's a drug device combination. It's a peptide. It's a very unique formulation. It has lots of multiple barriers of entry from coming into the market. We have dedicated site and facility. We are controlling our in-house supply chain. We are very positive and optimistic on staying a market leader upon the launch in Q3 as anticipated, lenalidomide. We have inventory to go. We have perfected the manufacturing. We look forward to lenalidomide launch in Q3 of this year.

至於 lanreotide，也是同樣的情況。它的製造非常複雜。如你所知，它是藥械組合（drug-device combination）。它是一種胜肽（peptide）。它的配方非常獨特。進入市場有許多多重進入障礙。我們有專用的廠址與設施。我們掌控內部供應鏈。我們對於在預期第三季上市後維持市場領導地位感到非常正面且樂觀，lenalidomide。我們已有庫存可供出貨。我們已將製造流程完善到位。我們期待今年第三季的 lenalidomide 上市。

Great. I'll take the second one on a specialty M&A potential, as we have stated before, company's focus and goal will turn to the specialty side going from next year, and many years to come after that. We have a full mass and great infrastructure for small molecule and large molecule with the pending Kashiv acquisition.

很好。我來回答第二個關於專科併購（M&A）潛在機會的問題。如我們先前所述，公司從明年起、以及往後多年，重點與目標將轉向專科領域。隨著 Kashiv 收購案待完成，我們在小分子與大分子方面都具備完整規模與優良的基礎設施。

We'll keep investing in our internal growth, R&D, and CapEx for affordable medicines and not take our eyes off. It's great business. Even the existing business is growing remarkably with the new pipeline launches, the women's health, with the lidocaine expansion, with the injectable expansion in the US. I mean, we could not even supply more. That is just a very positive sign. As you know, David, that would be positive because 90% scripts are written using generics product and always the complex products are in shortages, and we are there to support that. Very excited about that.

我們將持續投資於內生成長、研發與資本支出（CapEx），以提供可負擔的藥品，並不會忽視這一點。這是一門很好的業務。即便是既有業務，也因新產品線上市、女性健康業務、利多卡因（lidocaine）擴張，以及美國注射劑擴張而顯著成長。我的意思是，我們甚至無法供應更多。這是一個非常正面的訊號。如你所知，David，這會是正面的，因為 90% 的處方是使用學名藥產品，而複雜產品也經常短缺，我們就在那裡提供支援。對此非常興奮。

Biosimilars, we have enough and we will keep expanding with CapEx. With excess cash and other means, we would be focusing on CNS assets. Our team's looking at it, and we are also looking at oncology assets. We'll be adding pipeline internally and externally, and we'll share with you when we are ready.

在生物相似藥方面，我們的資源充足，並將持續透過資本支出擴張。憑藉多餘現金與其他方式，我們將聚焦於中樞神經系統（CNS）資產。我們的團隊正在評估，同時也在看腫瘤資產。我們會在內部與外部增加產品線，等我們準備好時會與各位分享。

Ash Verma, UBS.

Ash Verma，瑞銀（UBS）。

Congrats on the progress here. I had two questions on both individual products. Maybe just on lenalidomide. You've been reiterating 3Q as an approval and launch. Just help us understand if there could be any getting items from FDA side on granting the approval. Have you had any kind of late cycle review meeting recently? Any back and forth with the FDA that you can talk about?

恭喜你們在這裡取得的進展。我有兩個問題，分別針對兩個單一產品。先談 lenalidomide。你們一直重申第三季會獲批並上市。請協助我們理解，從 FDA 核准角度來看，是否可能還有任何待解決事項會影響核准？你們最近是否有任何後期審查會議（late cycle review meeting）？是否有任何你們可以談的、與 FDA 的往返溝通？

On iohexol, you're building out the SKU portfolio, obviously. Is the adoption of iohexol contingent on you having first all the SKUs, or can we start to see meaningful revenue contribution from what you have right now? And then it sort of builds out from the later dosing after that. If you can give any comment on that'll be great.

關於 iohexol，你們顯然正在擴充 SKU 組合。iohexol 的採用是否取決於你們先具備所有 SKU，還是我們可以從你們目前已有的 SKU 就開始看到有意義的營收貢獻？然後再隨著後續劑量規格逐步擴大。如果你能對此做任何評論就太好了。

On the lenalidomide, I'll take the first one. We responded to all the queries of FDA with very comprehensive response. We are very optimistic. As of today, we haven't had any negative feedback from FDA, we believe no news is a good news. It is under priority review, as FDA understand it's an unmet need. We remain very, very optimistic about 3Q launch, and we have inventory to go upon the approval of the product immediately.

關於 lenalidomide，我先回答第一個問題。我們已對 FDA 的所有詢問以非常完整的方式回覆。我們非常樂觀。截至目前，我們尚未收到 FDA 任何負面回饋；我們相信沒有消息就是好消息。它正處於優先審查（priority review），因為 FDA 理解這是一項未被滿足的需求。我們對第三季上市仍然非常、非常樂觀，而且在產品獲批後，我們有庫存可立即出貨。

On iohexol, our strategy was to get all the SKUs together, our R&D has completed all the work. It's not necessary to have all the SKUs, but I think we took a strategic position so that way we can get a bigger bite at the market share. Also, we are expanding the capacity. In 2026, iohexol does not have meaningful revenue, but in 2027 onward, it will add substantial revenue growth.

關於碘海醇（iohexol），我們的策略是把所有SKU都整合到位，我們的研發已完成所有工作。其實不一定需要涵蓋所有SKU，但我認為我們採取了策略性布局，這樣就能在市占率上取得更大份額。此外，我們也在擴充產能。2026年碘海醇不會帶來顯著營收，但自2027年起，將帶來可觀的營收成長。

Matt Dellatorre, Goldman Sachs.

高盛（Goldman Sachs）的Matt Dellatorre。

Congrats on the strong quarter. Maybe stepping back a bit, Chirag, you kicked off the call highlighting how Amneal is in the most transformative period in the company's history. I think two big things that come to mind here is obviously the recent biosimilars integration and also the Pfizer GLP-1 partnership. I know you discussed the biosimilar side a bit already, but maybe just walk us through what you're most focused on with respect to both of these programs over the next 6-12 months. What would you maybe highlight, beyond these programs that you're most excited about that you think we should start paying attention to?

恭喜本季表現強勁。或許先退一步看，Chirag，你在開場時提到Amneal正處於公司史上最具轉型意義的時期。我想到的兩個重點，顯然是近期的生物相似藥整合，以及與輝瑞（Pfizer）的GLP-1合作夥伴關係。我知道你已經談過一些生物相似藥的部分，但能否帶我們了解一下，未來6到12個月你對這兩個計畫各自最聚焦的重點是什麼？另外，除了這些計畫之外，你最期待、也覺得我們應該開始關注的還有哪些重點？

Just on the affordable medicine side, you guys have highlighted significant pickup in demand for estrogen patches post the recent black box removal for those types of products. Maybe just walk us through how large is that market potential there, and how much is Amneal positioned to capture?

另外在平價藥品（affordable medicine）方面，你們提到在近期移除黑框警語後，雌激素貼片的需求顯著回升。能否請你們說明一下，這個市場潛力有多大，以及Amneal有多大能力去掌握？

Great. I'll start with affordable medicines, the existing business. As I said, we're the most excited since last seven years. We used to have this kind of excitement from 2010 to 2018, and those times have come back. Existing, the two reasons, the existing products, huge demand for the estrogen patches, and we make them right here in New Jersey, and expansion is underway 24 by 7. Our teams are working. We were fortunate to work with the equipment supplier to bring the equipment earlier, and we look to triple the capacity by next year. It's a huge addition in revenue.

很好。我先從平價藥品、也就是既有業務談起。如我所說，這是我們過去七年來最興奮的一次。我們在2010到2018年期間曾有過這樣的興奮感，而現在那樣的時期又回來了。就既有產品而言，有兩個原因：雌激素貼片需求非常強勁，而我們就在新澤西州本地生產，且擴產正以每週7天、每天24小時的方式進行。我們的團隊正在全力投入。我們很幸運能與設備供應商合作，提前把設備到位，並計畫在明年將產能提升至三倍。這將為營收帶來很大的增量。

Also, we're expanding lidocaine, that is also in shortage. That demand is going up as well, the lidocaine patches. With the patches, with ophthalmics in high demand, with even the regular products being in a high demand, and new product launches, affordable medicines could add, it's a bigger range, but could add $1 billion to $2 billion of new revenue from now to 2030. That, we are very excited with our existing pipeline, new product launches, and the in-line products. Amazing times coming up in affordable medicines category. Biosimilars, we have spoken enough, a huge growth opportunity.

此外，我們也在擴充利多卡因（lidocaine），該產品同樣處於短缺狀態。利多卡因貼片的需求也在上升。在貼片、眼科用藥需求強勁，加上一般產品也處於高需求，以及新產品上市的帶動下，平價藥品業務在現在到2030年之間，可能新增10億到20億美元的新營收（區間較大）。我們對既有產品線、即將上市的新產品，以及在售產品都非常有信心。平價藥品類別即將迎來非常好的時期。至於生物相似藥，我們已談得很多了，這是一個巨大的成長機會。

Now let's -- in specialty, CREXONT keep expanding. Brekiya is breaking the records and Unithroid is steady growth. We expect these three brands to continue to grow. On top of it, organic pipeline would be revealed within probably in first quarter next year. And we will also look to be active in potential partnership acquisitions of branded products that fits our commercial infrastructure and fits our -- the category we play, and we'll keep expanding, and we may add oncology assets as well, since we have the biosimilar oncology team already, more market knowledge over last three years. That's very exciting news on specialty, and we look to share that as we have that information.

接著談專科藥（specialty），CREXONT持續擴張。Brekiya屢創紀錄，Unithroid則維持穩健成長。我們預期這三個品牌將持續成長。此外，我們的自有（organic）產品管線，可能會在明年第一季左右揭露。我們也會積極尋求潛在的合作或併購品牌產品，只要符合我們的商業化基礎設施與我們所聚焦的治療領域；我們會持續擴張，也可能加入腫瘤資產，因為我們已經有生物相似藥腫瘤團隊，過去三年累積了更多市場知識。這些都是專科藥方面非常令人振奮的消息，待資訊更完整時我們也會對外分享。

On GLP-1 peptides, Pfizer's results are good on clinical trials and our partnerships moving extremely well. We look to expand the partnership, and our both plants are coming up as fast as they can and should be operational 2029 and 2030, and we look to start supplying in 2030. Also, we have evaluated the markets that we are given the exclusive commercial rights, like India and Egypt, and those are looking good as well. Very excited on a GLP-1 peptide opportunity. Also with this large infrastructure, it opens up for additional manufacturing of peptides as well as finished products for either other branded companies or in the future, some genetics products.

在GLP-1胜肽方面，輝瑞的臨床試驗結果良好，我們的合作進展也非常順利。我們希望擴大合作，而我們兩座工廠都在以最快速度建置，預計於2029與2030年投入運作，並計畫在2030年開始供貨。此外，我們也評估了我們擁有獨家商業化權利的市場，例如印度與埃及，這些市場前景也相當不錯。我們對GLP-1胜肽機會非常期待。同時，這套大型基礎設施也為額外的胜肽製造，以及為其他品牌公司或未來某些學名藥產品提供成品製造，打開了更多可能性。

On biosimilar, Matt, I just want to add, in next 6, 12 months, we are very much focused on integrating Kashiv and also advancing our pipeline on abatacept, Nplate, and Cimzia. Our goal is to -- because R&D is going to be key, and that's what Amneal is always shining, to work with Kashiv and enhance R&D capabilities where we can file three or four biosimilars a year, which is potentially possible.

關於生物相似藥，Matt，我想補充的是，未來6到12個月我們非常聚焦於整合Kashiv，同時推進abatacept、Nplate與Cimzia的產品管線。我們的目標是——因為研發將是關鍵，而這正是Amneal一向最突出的地方——與Kashiv合作並強化研發能力，讓我們有機會每年申報三到四個生物相似藥，這在潛力上是可行的。

New into biologics, we are also looking into different platforms within the biologics and look at some new drug device combination within the biologics to come out with kind of a 505(b)(2) or biosimilar. We are just focused on biosimilar. There are plenty of products to go, advancing our pipeline and infrastructure and some of the 505(b)(2)s within the biosimilars.

在生物製劑（biologics）方面，我們也在評估不同的平台，並研究一些生物製劑中的新型藥物—裝置組合（drug-device combination），以推出類似505(b)(2)或生物相似藥的產品。我們不只專注於生物相似藥。可做的產品很多，我們會持續推進產品管線與基礎設施，也會在生物相似藥領域內推動部分505(b)(2)專案。

I think we answered. Thank you, Mike.

我想我們已經回答了。謝謝你，Mike。

We have reached the end of the Q&A session. I will now turn the call back to Co-CEO, Chirag Patel, for closing remarks.

問答環節到此結束。我現在把電話交回聯合執行長（Co-CEO）Chirag Patel作結語。

Well, thank you very much, everybody, and have a great Thursday. Take care.

好的，非常感謝各位，祝大家週四愉快。保重。

This concludes today's call. Thank you for attending. You may now disconnect.

今天的電話會議到此結束。感謝各位參與。您現在可以掛線。