Amneal Pharmaceuticals, Inc. (AMRX) 2026 Q1 法說會逐字稿

Good morning, and welcome to today's Amneal Pharmaceuticals investor call.

早安，歡迎參加今日的 Amneal Pharmaceuticals 投資人電話會議。

I will now turn the call over to Amneal's Head of Investor Relations, Tony DiMeo.

接下來我將把電話會議交給 Amneal 投資人關係主管 Tony DiMeo。

Good morning, and thank you for joining Amneal Pharmaceuticals investor call. This morning, we issued a press release announcing Amneal agrees to acquire Kashiv BioSciences and reporting preliminary Q1 results. The press release and presentation are available at amneal.com.

早安，感謝各位參加 Amneal Pharmaceuticals 投資人電話會議。今天早上，我們發布新聞稿，宣布 Amneal 同意收購 Kashiv BioSciences，並公布第一季初步業績。新聞稿與簡報可於 amneal.com 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 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 press release and presentation.

本次電話會議中，關於非歷史事實之事項所作的若干陳述（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得之資訊。請參閱「前瞻性陳述之警示聲明」章節，以了解可能影響未來表現的因素。我們亦將討論非 GAAP 指標。關於這些指標的使用及與 GAAP 的調節資訊，載於新聞稿與簡報中。

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

今日與會者包括共同創辦人暨共同執行長 Chirag 與 Chintu Patel；財務長 Tasos Konidaris；以及法務長 Jason Daly。接下來我把電話會議交給 Chirag。

Thank you, Tony. Today is a defining moment for Amneal. This morning, we announced that Amneal agrees to acquire Kashiv BioSciences, creating a fully integrated global biosimilars leader and positioning Amneal to become the number 1 affordable medicines company in the United States. We have long said this was our goal. And today, we're showing exactly how to get there.

謝謝你，Tony。今天對 Amneal 而言是具有里程碑意義的一刻。今天早上，我們宣布 Amneal 同意收購 Kashiv BioSciences，打造一個完全整合的全球生物相似藥領導者，並使 Amneal 具備成為美國第一大平價藥品公司的定位。我們長期以來一直表示這是我們的目標。而今天，我們正清楚展示如何達成。

Turning to slide 3. I'll begin the call by discussing the strategic fit of the acquisition and the remarkable biosimilar opportunity ahead. Chintu will share more about Kashiv, our combined capabilities and the robust biosimilar portfolio we will have. Tasos will discuss the transaction, our financial outlook and Amneal's very strong first quarter results, which we preannounced this morning.

請看第 3 頁投影片。我將先就本次收購的策略契合度，以及前方極具吸引力的生物相似藥機會進行說明。Chintu 將進一步分享 Kashiv、我們合併後的能力，以及我們將擁有的強勁生物相似藥產品組合。Tasos 將說明本交易、我們的財務展望，以及我們今天早上預先公告的 Amneal 非常強勁的第一季業績。

At a high level, Q1 marked another consecutive quarter of strong top- and bottom-line growth with revenue up 4%, adjusted EBITDA up 19% and EPS up 29%. Our strong start of the year, combined with growth of existing and new products, gives us confidence to raise our stand-alone guidance for 2026. This consistent performance is something investors have come to expect from Amneal and something we take great pride in.

整體而言，第一季再度連續一季展現強勁的營收與獲利成長：營收成長 4%，調整後 EBITDA 成長 19%，每股盈餘（EPS）成長 29%。今年開局強勁，加上既有與新產品的成長，使我們有信心上調 2026 年獨立（未合併）財測指引。這樣一貫的表現，是投資人對 Amneal 的期待，也是我們引以為傲之處。

On slide 4, we provide an executive summary of this combination. First, this is a highly strategic transaction that creates fully integrated global biosimilars leader. This unlocks direct access to more than $300 million of worldwide biologic loss of exclusivity over the next decade by bringing together Kashiv's deep R&D and manufacturing capabilities with our proven commercial scale. This combination builds on a longstanding partnership that significantly reduces execution risk.

在第 4 頁投影片，我們提供本次結合的管理層摘要。第一，這是一項高度策略性的交易，可打造完全整合的全球生物相似藥領導者。透過結合 Kashiv 深厚的研發與製造能力，以及我們已驗證的商業化規模，本交易將在未來十年解鎖對全球超過 3 億美元生物製劑專利到期（失去獨占）機會的直接切入。此一結合建立在長期合作夥伴關係之上，可大幅降低執行風險。

Second, this combination creates immediate scale in biosimilars. We expect multiple launches each year going forward, supported by a robust pipeline of more than 20 biosimilars programs. Third, this adds biosimilars as a key growth pillar within affordable medicines. The transaction further diversifies our business and extends our growth profile well into 2030s, while also creating a footprint to expand internationally over time.

第二，此一結合可立即在生物相似藥領域形成規模。我們預期未來每年將有多項產品上市，並由超過 20 項生物相似藥計畫所構成的強勁研發管線支撐。第三，這使生物相似藥成為平價藥品業務中的關鍵成長支柱。本交易進一步分散我們的業務組合，並將成長曲線延伸至 2030 年代，同時也建立可隨時間推進的國際擴張據點。

And fourth, the deal is structured to create value from day 1. With a balanced mix of upfront consideration, performance-based milestones, we expect significant financial synergies and we maintain a disciplined financial profile with a clear path to deleverage to below 3x by 2028.

第四，本交易的架構設計可自第一天起創造價值。透過前期對價與以績效為基礎的里程碑付款之均衡組合，我們預期可產生顯著的財務綜效；同時我們將維持審慎的財務體質，並具備清晰的去槓桿路徑，目標於 2028 年將槓桿降至 3 倍以下。

Let me turn it over to Chintu to share more about Kashiv.

接下來我把時間交給 Chintu，請他進一步介紹 Kashiv。

Thank you, Chirag. Good morning, everyone. Going to slide 5. Today's acquisition announcement reflects our long-stated goal to be vertically integrated in biosimilars. I want to acknowledge the Amneal and Kashiv teams whose hard work made this possible.

謝謝你，Chirag。各位早安。請看第 5 頁投影片。今天的收購公告反映了我們長期以來所宣示的目標：在生物相似藥領域實現垂直整合。我要感謝 Amneal 與 Kashiv 團隊的努力，讓這一切成為可能。

Kashiv is a biologics platform built over 12 years with more than $900 million invested, 600-plus employees and four R&D and manufacturing sites. It brings proven capabilities, a differentiated portfolio and a global operational footprint in US and India, which provides reliable supply chain and cost efficiencies.

Kashiv 是一個歷經 12 年打造的生物製劑平台，累計投資超過 9 億美元，擁有 600 多名員工，以及四個研發與製造據點。其帶來已驗證的能力、差異化的產品組合，以及遍及美國與印度的全球營運版圖，可提供可靠的供應鏈與成本效率。

Turning to slide 6. Kashiv adds deep biosimilar development expertise and scaled US and India manufacturing, enabling multiple programs to run in parallel with speed and cost efficiency. The platform can support three to five biosimilars developments annually and offers end-to-end biologics capabilities from clone development and protein characterization through clinical and regulatory execution.

請看第 6 頁投影片。Kashiv 增添深厚的生物相似藥開發專業，以及美國與印度具規模的製造能力，使多個計畫得以並行推進，兼具速度與成本效率。該平台每年可支援 3 至 5 項生物相似藥開發，並提供端到端的生物製劑能力，涵蓋從細胞株（clone）開發與蛋白質特性分析，到臨床與法規執行。

These expertise spans key modalities and the vast majority of biologics, including microbials, monoclonal antibodies, fusion proteins, bispecifics, and cytokines. From a manufacturing perspective, drug substance capacity is expected to scale from 26,000 liter in 2026 to 75,000 liter by 2028. Combined with Amneal, this creates a fully integrated global biosimilar platform.

這些專業涵蓋關鍵技術模態與絕大多數生物製劑，包括微生物、單株抗體、融合蛋白、雙特異性抗體，以及細胞激素。就製造而言，原料藥（drug substance）產能預期將由 2026 年的 26,000 公升擴增至 2028 年的 75,000 公升。與 Amneal 結合後，將形成一個完全整合的全球生物相似藥平台。

I will hand it over to Tasos to share more on the transaction.

接下來我把時間交給 Tasos，請他進一步說明本交易。

Good morning, and thank you, Chintu. Turning to the transaction overview on slide 7. As you can see, we have purposely structured this deal to balance upfront value and success-based consideration to ensure alignment of interest. The upfront value of $750 million is a 50-50 mix of cash and equity. The equity portion translates to approximately $29 million of Amneal shares, representing 8% equity dilution.

早安，謝謝你，Chintu。請看第 7 頁投影片的交易概覽。如各位所見，我們刻意將本交易架構設計為在前期價值與以成功為基礎的對價之間取得平衡，以確保利益一致。7.5 億美元的前期對價由現金與股權各占 50% 組成。股權部分相當於約 2,900 萬美元的 Amneal 股票，代表 8% 的股權稀釋。

In addition to the upfront value, the deal terms include potential milestones of up to $350 million, contingent upon attaining certain regulatory approval milestones as well as potential royalties over 12 years contingent on achieving certain gross profit levels. Finally, Amneal will fund operations between signing and closing of the deal. We spent a lot of time structuring this transaction to ensure it aligns incentives with the large commercial opportunities ahead of us and doing it in the most balance sheet-friendly way.

除前期對價外，交易條款亦包含最高 3.5 億美元的潛在里程碑付款，取決於達成特定法規核准里程碑；此外，亦包含為期 12 年的潛在權利金，取決於達成特定毛利水準。最後，Amneal 將在簽約至交割期間為營運提供資金。我們投入大量時間設計此交易架構，以確保其能在前方龐大的商業機會下達到誘因一致，並以對資產負債表最友善的方式進行。

The transaction will be funded by cash on hand as well as some additional debt, and we expect the combined company's net debt leverage ratio at the end of 2026 to be 3.7x adjusted EBITDA, only a slight increase to the 3.5x adjusted EBITDA at the end of 2025. It is important to note that we expect to resume our deleveraging in 2027 and expect our net leverage ratio to be 3x below adjusted EBITDA -- net debt adjusted EBITDA by 2028. Finally, we expect this highly strategic transaction to close in a few months as we work through annual shareholder approval and customary closing conditions and regulatory approvals.

本交易將以手上現金以及部分新增負債籌資；我們預期合併後公司於 2026 年底的淨負債槓桿比率為調整後 EBITDA 的 3.7 倍，僅較 2025 年底調整後 EBITDA 的 3.5 倍略為上升。重要的是，我們預期將於 2027 年恢復去槓桿，並預期於 2028 年將淨槓桿比率降至調整後 EBITDA 的 3 倍以下——亦即淨負債／調整後 EBITDA 於 2028 年低於 3 倍。最後，隨著我們完成年度股東核准、慣例交割條件及監管核准等程序，我們預期這項高度策略性的交易將於數個月內完成交割。

Let me now share our expected combined financial growth profile on slide 8. First, we're embarking on this acquisition from a position of strength. As you may have seen from our press release this morning, we announced record first quarter preliminary financial results, and we also raised our full year stand-alone guidance. Amneal's ability to deliver solid top line growth and double-digit adjusted EPS growth in a tumultuous macroeconomic environment is a testament to our strategic choices, strong execution, and relevancy of our products.

現在讓我在第 8 頁投影片分享我們預期的合併後財務成長概況。首先，我們是以強勁的基礎來推進這項收購。如同各位可能已從今天早上的新聞稿看到的，我們公布了創紀錄的第一季初步財務結果，同時也上調了全年獨立（stand-alone）財測指引。在動盪的總體經濟環境下，Amneal 仍能實現穩健的營收成長與兩位數的調整後 EPS 成長，這證明了我們的策略選擇、強而有力的執行力，以及產品的市場相關性。

Consequently, on a combined basis, including Kashiv, our 2026 view remains largely unchanged aside from a small impact to cash flow related to near-term transaction and integration costs. Importantly, we're maintaining the higher adjusted EBITDA and EPS outlook, which we believe is a clear signal of the underlying momentum and confidence in the trajectory of our business.

因此，在合併口徑下（包含 Kashiv），我們對 2026 年的看法大致維持不變，僅因近期交易與整合成本對現金流造成些微影響。更重要的是，我們維持較高的調整後 EBITDA 與 EPS 展望；我們相信這清楚傳達了業務基本面動能，以及對公司發展軌跡的信心。

For 2027 and beyond, we expect the combined company to continue to grow both in terms of top- and bottom-line performance. And by 2030, we expect revenues to have grown by approximately $1.2 billion or 40% over 2026 and EPS up by approximately $0.70 or 70% over 2026. Finally, we expect substantial operating cash flow growth, which supports our continued deleveraging. While increased financial performance is important, I cannot emphasize enough the impact this acquisition is having in enhancing our diversification, providing us with access to large markets into 2030 and beyond, just like our GLP-1 deal with Pfizer.

展望 2027 年及之後，我們預期合併後公司將在營收與獲利表現（上、下線）兩方面持續成長。到 2030 年，我們預期營收相較 2026 年增加約 12 億美元（或 40%），EPS 相較 2026 年提升約 0.70 美元（或 70%）。最後，我們預期營運現金流將大幅成長，支持我們持續去槓桿。雖然財務表現提升很重要，但我再怎麼強調也不為過：這項收購在強化我們的多元化方面帶來的影響，讓我們得以進入 2030 年及更長遠的大型市場，就如同我們與輝瑞（Pfizer）的 GLP-1 交易一樣。

Let me now hand it back to Chirag.

接下來我把時間交還給 Chirag。

Thank you, Tasos. On slide 9, this transaction fits squarely in our long-term strategy. It adds biosimilars as a key growth pillar and positions us higher on the value curve with greater scale and higher growth.

謝謝你，Tasos。在第 9 頁投影片，這筆交易完全契合我們的長期策略。它將生物相似藥納入關鍵成長支柱，並以更大的規模與更高的成長性，讓我們在價值曲線上處於更高位置。

So why now? In looking at slide 10, it's because we are entering the golden era for biosimilars. The global market is expected to grow from about $40 billion today towards $200 billion by 2035, driven by the largest biologic loss of exclusivity in history over next decade. Advancing to slide 11. Biosimilars represent the next major wave of affordable medicines, and we are at an inflection point.

那為什麼是現在？看第 10 頁投影片，原因是我們正進入生物相似藥的黃金時代。全球市場預期將從目前約 400 億美元成長至 2035 年約 2,000 億美元，主要動能來自未來十年將出現史上最大規模的生物製劑專利到期（失去獨占）。接著到第 11 頁投影片。生物相似藥代表下一波可負擔藥品的重大浪潮，而我們正處於拐點。

Physician adoption is accelerating, patient access is expanding and the US regulatory advancements are lowering development time and cost. Today, about half of US drug spend is concentrated in high-cost biologics. Furthermore, biopharma pipelines continue to shift towards biologics with most therapies in development being large molecules. Each biologic is a future biosimilar opportunity. With biosimilars, access expands and cost lowers, delivering meaningful value for patients and the healthcare system.

醫師採用正在加速、病患可近性正在擴大，而美國監管的進展正在降低開發時間與成本。目前，美國藥品支出約有一半集中在高成本的生物製劑。此外，生技製藥的研發管線持續轉向生物製劑，開發中的多數療法為大分子。每一個生物製劑都是未來的生物相似藥機會。透過生物相似藥，可擴大可近性並降低成本，為病患與醫療體系帶來顯著價值。

In 2024, biosimilars were estimated to have saved the US healthcare system $20 billion. There's a powerful opportunity to improve affordability and expand access because what is the point of innovation if it is not accessible. Turning to slide 12. Despite this opportunity, there are only a handful of integrated global players.

2024 年，估計生物相似藥為美國醫療體系節省了 200 億美元。在提升可負擔性與擴大可近性方面存在強大的機會，因為如果創新無法被取得，那創新的意義何在。轉到第 12 頁投影片。儘管有這樣的機會，具備整合能力的全球性業者仍屈指可數。

And today, there is no clear US biosimilar leader. Most players have relied on partnerships to date. With Kashiv, we bring together development, manufacturing and commercialization, enabling faster execution, smarter and bigger portfolio choices, and ability to capture full economics. We believe this level of vertical integration is a true competitive advantage.

而在今天，美國市場尚無明確的生物相似藥領導者。多數業者迄今主要依賴合作夥伴關係。透過 Kashiv，我們把研發、製造與商業化整合在一起，使我們能更快執行、做出更聰明且更具規模的產品組合選擇，並有能力掌握完整的經濟效益。我們相信，這種程度的垂直整合是真正的競爭優勢。

I'll pass it back to Chintu to share more on the combined capabilities and portfolio.

我把時間交給 Chintu，請他分享更多合併後的能力與產品組合。

Thank you. Chirag shared with you the strategy on why biosimilars. Let me share with you the clear reason why Amneal. Looking at slide 13, since our founding, we have built a leading affordable medicine business. We are now number 3 in US retail generics with over 280 products across dosage forms with one of the most complex portfolio in the industry. This is a natural extension of our strategy, and we will execute with the same rigor and discipline in biosimilars.

謝謝。Chirag 已向各位分享了為何選擇生物相似藥的策略。接下來我想分享為何是 Amneal 的明確理由。看第 13 頁投影片，自成立以來，我們打造了領先的可負擔藥品事業。我們目前是美國零售學名藥第 3 大，擁有超過 280 項跨劑型產品，且是業界最複雜的產品組合之一。這是我們策略的自然延伸，我們也將以同樣的嚴謹與紀律在生物相似藥領域執行。

On slide 14, we show how this combination brings together end-to-end biosimilar capabilities. Kashiv adds scientific expertise and in-house development from cell line through approval, along with scaled biologics manufacturing across a global footprint. Amneal brings a proven commercial engine, leveraging our leading affordable medicines business, long-standing customer relationships, and the specialty branded infrastructure to drive market access and uptake. Built on a 10-year plus partnership with Kashiv, our capabilities are highly complementary and positions us to execute well.

在第 14 頁投影片，我們展示這次結合如何匯聚端到端的生物相似藥能力。Kashiv 帶來科學專業與內部研發能力，涵蓋從細胞株到核准的全流程，並在全球據點具備規模化的生物製劑製造能力。Amneal 則帶來經驗證的商業化引擎，運用我們領先的可負擔藥品事業、長期客戶關係，以及專科品牌藥的基礎設施，推動市場准入與採用。建立在與 Kashiv 超過 10 年的合作夥伴關係之上，我們的能力高度互補，使我們具備良好的執行定位。

Next, let's look at slide 15 and the combined portfolio. Together, we have a combined portfolio of 20-plus biosimilars that targets over $100 billion in US opportunity and more globally. First, we expect to have six commercial biosimilars by 2027, including biosimilars for Avastin and Denosumab and a biosimilar for XOLAIR, which is pending approval. Second, we expect six or more additional approvals from our advanced pipeline by 2030.

接著看第 15 頁投影片與合併後的產品組合。合計而言，我們擁有超過 20 項生物相似藥的組合，瞄準美國超過 1,000 億美元的機會，並在全球市場也有更大的機會。第一，我們預期到 2027 年將有 6 項已商業化的生物相似藥，包括 Avastin 與 Denosumab 的生物相似藥，以及一項尚待核准的 XOLAIR 生物相似藥。第二，我們預期到 2030 年，先進研發管線將帶來 6 項或更多的額外核准。

And third, in 2030 and beyond, we have a deep pipeline of future programs that extend our growth well into the next decade. Strategically, this is a balanced and durable portfolio mix. Many opportunities are biologics with less than one or two competitors expected and others are widely used products with large markets, creating a durable and scalable growth engine.

第三，在 2030 年及之後，我們擁有深厚的未來專案管線，將成長動能延伸至下一個十年。從策略角度來看，這是一個均衡且具韌性的產品組合配置。許多機會來自預期競爭者少於一到兩家的生物製劑，另一些則是市場龐大、使用廣泛的產品，從而打造具韌性且可擴展的成長引擎。

On slide 16, we have a clear line of sight to steady cadence of near-term catalysts from Kashiv. First, lanreotide is a high-value partner asset expected to be approved in quarter 3. Second, biosimilar XOLAIR follows with anticipated approval at year-end, which is another Kashiv partnered asset that we now capture full value for. After that, we see a pipeline of additional approvals in 2028 and 2029, including biosimilars for ORENCIA and CIMZIA, each representing meaningful future growth drivers.

在第 16 頁投影片，我們對 Kashiv 在短期內帶來的穩定催化劑節奏有清晰的可視性。第一，lanreotide 是一項高價值的合作夥伴資產，預期在第三季獲得核准。第二，XOLAIR 生物相似藥接續其後，預期於年底獲准；這也是另一項 Kashiv 的合作夥伴資產，而我們現在可取得其完整價值。之後，我們看到 2028 年與 2029 年還有更多核准的管線，包括 ORENCIA 與 CIMZIA 的生物相似藥，兩者皆代表具意義的未來成長驅動因素。

Let me now pass it back to Tasos.

接下來我把時間交還給 Tasos。

Thank you, Chintu. I'm very pleased to share with you our exceptional first quarter preliminary results, our confidence in the strength of our business, which translates to increasing our full year guidance on a stand-alone basis. And finally, our proposed acquisition of Kashiv BioSciences, which positions Amneal as a leader in the large global biosimilars market.

謝謝你，Chintu。我很高興與各位分享我們卓越的第一季初步結果，以及我們對業務強勁實力的信心；這也反映在我們以獨立口徑上調全年財測指引。最後，我們擬議收購 Kashiv BioSciences，這將使 Amneal 在龐大的全球生物相似藥市場中成為領導者。

Let me first start with our first quarter preliminary financial results, which were characterized by robust top line growth, exceptional bottom line growth and continuing deleveraging. Moving to slide 22 in the appendix. Total net revenues in the first quarter of $723 million grew 4%. Q1 Affordable Medicines revenue of $423 million grew 2%, driven by strong performance of key women's health and ADHD products due to high market demand and increased Amneal supply. These high-margin products drove Q1 segment gross margin to 47.3%, up 320 basis points versus Q1 of 2025.

我先從我們第一季的初步財務結果談起，其特點是營收端（top line）強勁成長、獲利端（bottom line）卓越成長，以及持續去槓桿。請翻到附錄的第22頁投影片。第一季總淨營收為7.23億美元，成長4%。第一季平價藥品（Affordable Medicines）營收為4.23億美元，成長2%，主要受惠於關鍵女性健康與ADHD產品在市場需求旺盛及Amneal供應增加下的強勁表現。這些高毛利產品帶動第一季該事業部毛利率達47.3%，較2025年第一季提升320個基點。

We continue to expect Affordable Medicines revenue growth of 7% to 8% this year, driven by the strength of new product launches and strong execution by our teams. Q1 Specialty revenue of $133 million grew 23%. First quarter CREXONT revenue of $21 million reflects continued strong market uptake. Earlier this week, we shared with you our additional Phase 4 data, which showed CREXONT as having more than three hours good downtime versus RYTARY, reflecting the CREXONT's compelling clinical profile.

我們仍預期今年平價藥品營收將成長7%至8%，動能來自新產品上市的強勁表現以及團隊的有力執行。第一季專科（Specialty）營收為1.33億美元，成長23%。第一季CREXONT營收為2,100萬美元，反映市場持續強勁採用。本週稍早我們與各位分享了額外的第四期（Phase 4）數據，顯示相較於RYTARY，CREXONT可多出超過三小時的良好停機時間（good downtime），凸顯CREXONT具吸引力的臨床特性。

In addition, we're also delighted with the strong launch trajectory of Brekiya for cluster headaches. Revenue in Q1 2026 was $4.6 million compared to $1.6 million in Q4 2025. This rapid adoption as well as feedback from patients and prescribers confirms the substantial market need and long-term revenue potential for Brekiya.

此外，我們也對Brekiya用於叢集性頭痛的強勁上市軌跡感到非常振奮。2026年第一季營收為460萬美元，較2025年第四季的160萬美元增加。這樣的快速採用，以及來自病患與處方醫師的回饋，證實Brekiya具備可觀的市場需求與長期營收潛力。

Turning over to AvKARE, where Q1 revenues of $166 million declined by $6 million or 4% as strong growth in our government channel was offset by expected decline in the low-margin distribution channel. As you recall, this is part of our strategy to enhance profitability, and we're happy to report that AvKARE's gross margin in the quarter grew by 690 basis points versus first quarter last year.

接著談AvKARE，第一季營收為1.66億美元，減少600萬美元或下滑4%；政府通路的強勁成長，被預期中的低毛利分銷通路下滑所抵銷。如各位所記得，這是我們提升獲利能力策略的一部分；我們也很高興報告，AvKARE本季毛利率較去年第一季提升690個基點。

Moving to slide 21. From a bottom-line perspective, the strong growth of adjusted gross margins by approximately 500 basis points and thoughtful expense management translated to Q1 2026 adjusted EBITDA of $202 million, up 19% and Q1 adjusted EPS of $0.27, up 29%. Finally, our strong financial performance and discipline continue to reduce leverage and our net leverage ratio in March of 2026 declined to 3.5x adjusted EBITDA compared to 3.9x adjusted EBITDA in March of 2025.

請翻到第21頁投影片。從獲利端來看，調整後毛利率約提升500個基點，加上審慎的費用管理，使2026年第一季調整後EBITDA達2.02億美元，成長19%；第一季調整後每股盈餘（EPS）為0.27美元，成長29%。最後，我們強勁的財務表現與紀律持續降低槓桿；截至2026年3月，我們的淨槓桿比率降至調整後EBITDA的3.5倍，低於2025年3月的3.9倍。

So in summary, and before I turn to our acquisition of Kashiv BioSciences, our business fundamentals, financial outlook, and balance sheet have never been stronger, which positions us well to consider such a strategic deal. Turning back to the acquisition for a moment, as we outlined on slide 17, this is a highly synergistic transaction, adding significant value to our commercial and operating business model and providing substantial financial benefits over the course of time.

總結而言，在我轉到我們收購Kashiv BioSciences之前，我們的業務基本面、財務展望與資產負債表從未如此強健，這使我們具備良好條件來評估此類策略性交易。回到收購案本身，如同我們在第17頁投影片所概述，這是一筆高度具協同效益的交易，能為我們的商業與營運商業模式帶來顯著價值，並在時間推移中提供可觀的財務效益。

From an integration perspective, we're combining Kashiv's R&D and manufacturing expertise with Amneal's commercial engine. We're strengthening market access, expanding in hospitals, and accelerating international growth. With our shared global platform, we accelerate time to market at lower cost. From a financial standpoint, we expect $400 million to $500 million in cumulative financial synergies over time.

從整合角度來看，我們將結合Kashiv在研發與製造方面的專長，以及Amneal的商業引擎。我們將強化市場准入、擴展醫院端布局，並加速國際成長。憑藉共同的全球平台，我們能以更低成本加快上市時程。從財務面來看，我們預期隨時間累積可實現4億至5億美元的財務協同效益。

There are two key elements to this. First, we're now capturing full economics from partnered assets by eliminating milestones and profit-sharing obligations that existed as part of prior licensing deals. Second, we also expect to realize substantial tax benefits as well as incentives from the local Indian authorities. Importantly, this deal goes beyond traditional cost synergies. It creates strategic scale and durable value while also avoiding the significant time and capital needed to build a biosimilars platform organically.

這其中有兩個關鍵要素。第一，透過消除先前授權交易中存在的里程碑付款與利潤分成義務，我們如今能從合作資產中取得完整經濟利益。第二，我們也預期可實現可觀的稅務效益，以及來自印度當地政府機關的獎勵措施。重要的是，這筆交易不僅止於傳統的成本協同。它在創造策略性規模與長期價值的同時，也避免了以有機方式建立生物相似藥平台所需投入的大量時間與資本。

Let me now hand it back over to Chirag.

接下來我把時間交回給Chirag。

Thank you, Tasos. On slide 18, since 2019, we have built a stronger and more diversified Amneal, and delivered consistent top- and bottom-line growth each year. We have done this by executing well across our business. We launched 20 to 30 products annually, expanded especially with CREXONT and Brekiya, entered biosimilars with our first products, established a novel GLP-1 collaboration with Pfizer, expanded internationally, and acquired and more than doubled the AvKARE business.

謝謝你，Tasos。在第18頁投影片，自2019年以來，我們打造了更強大且更多元的Amneal，並且每年都實現營收端與獲利端的持續成長。我們是透過在各項業務上的良好執行來達成。我們每年推出20到30項產品，特別透過CREXONT與Brekiya擴張，並以首批產品切入生物相似藥領域，與輝瑞（Pfizer）建立創新的GLP-1合作，拓展國際市場，並透過收購使AvKARE業務規模成長且超過翻倍。

That said, the opportunity ahead remains significantly greater than what we have achieved to date. We envision Amneal 2030 as a much larger, more diversified biopharmaceutical company with more than 400 retail and injectable medicines, mostly complex and differentiated, a large pipeline of 20-plus biosimilars and multiple specialty branded products advancing the standard of care, while Amneal fills hundreds of millions of US prescriptions each year.

即便如此，未來的機會仍遠大於我們迄今所取得的成果。我們對Amneal 2030的願景，是成為一家規模更大、更多元的生物製藥公司，擁有超過400項零售與注射劑藥品（多為複雜且具差異化），具備20項以上生物相似藥的大型產品線（pipeline），以及多項推動照護標準提升的專科品牌產品；同時，Amneal每年將為美國開立並供應數億張處方。

In summary, the key takeaway from today's call are on slide 19. Today marks a pivotal moment for Amneal, establishing a fully integrated global biosimilars leader, strengthening our diversified portfolio, and extending our durable growth profile into 2030s. Our strategy remains clear to become America's number 1 affordable medicines company and a leading global provider of essential medicines because innovation only matters when it reaches the patients.

總結而言，今天電話會議的重點整理在第19頁投影片。今天對Amneal而言是關鍵轉捩點：我們建立了完整整合的全球生物相似藥領導者地位，強化多元化產品組合，並將我們可持續的成長曲線延伸至2030年代。我們的策略依然清晰：成為美國第一的平價藥品公司，以及全球重要的必需藥品供應商，因為創新只有在真正觸及病患時才有意義。

With that, thank you, and we will open the line for questions.

以上，謝謝各位，我們現在開放提問。

(Operator Instructions) Matt Dellatorre, Goldman Sachs.

（接線員指示）高盛（Goldman Sachs）的Matt Dellatorre。

Congrats on the deal. I know this was a long time coming, so very exciting. Maybe two questions, if I may. First, just on the commercial strategy for the new expanded portfolio. I see you have both the mega blockbusters like OPDIVO and KEYTRUDA and also many sub-$5 billion assets in there.

恭喜完成這筆交易。我知道這是醞釀已久的案子，所以非常令人振奮。如果可以的話，我有兩個問題。第一個是關於擴大後新產品組合的商業策略。我看到你們同時涵蓋像OPDIVO與KEYTRUDA這類超級重磅產品，也有許多低於50億美元規模的資產。

And then also, it's a healthy mix of pharmacy benefit and medical benefit drugs. So could you maybe just speak a bit on how you approach portfolio construction and what type of assets we should expect over time as you all disclose more and the pipeline expands?

另外，產品也同時涵蓋藥局給付（pharmacy benefit）與醫療給付（medical benefit）藥物的健康組合。因此你們能否談談你們如何進行產品組合建構，以及隨著你們揭露更多資訊、產品線擴大後，長期而言我們應該期待哪些類型的資產？

And then I realize you're primarily focused on the US market, but can you just remind us how you are thinking about the international biosimilars business as well? And then maybe stepping back, a question for Chirag. When you look at this new kind of combined company you all have now, what would you highlight as maybe the two to three specific things that you're most excited about and which you think could drive upside to this long-term guidance that you're giving today?

另外我知道你們主要聚焦美國市場，但能否也提醒我們，你們如何看待國際生物相似藥業務？再退一步，給Chirag一個問題。當你看待現在這家新的合併後公司時，你會特別強調哪兩到三件你最感到興奮、且你認為可能推動你們今天所給出的長期指引上行的具體因素？

Thank you, Matt. So let me address the portfolio mix first, the Kashiv pipeline. So markets are shifting more towards PBM, as we know. We predict 70%, 75% market to be driven by private label, PBMs, specialty pharmacies and 25% or so percentages will be driven by buy and build. So it's a well-thought-out portfolio.

謝謝你，Matt。我先回應產品組合的配置，也就是Kashiv的產品線。如我們所知，市場正更多轉向PBM。我們預測有70%、75%的市場將由自有品牌、PBM、專科藥局所驅動，而約25%左右將由buy and build所驅動。因此這是一個經過周全規劃的產品組合。

If you look at the disclosed product, there are certain undisclosed product that just like what we did with small molecule, we want to be the big player, relevant player and mostly focused on niche products. So how do we achieve that? That is why we have some of the big products like KEYTRUDA, OPDIVO, DUPIXENT, but each has its own reason why we have selected. Just to give you an example, DUPIXENT requires such a large biologics capacity, we're building it. And at the right time, it will be ready to deliver. Then we have niche products, which we expect two to three competitors.

如果你看已揭露的產品，還有一些尚未揭露的產品，就像我們在小分子領域所做的一樣，我們希望成為大型玩家、具影響力的玩家，並且主要聚焦於利基產品。那我們要如何做到？這就是為什麼我們會有一些大型產品，例如 KEYTRUDA、OPDIVO、DUPIXENT，但每一個都有其被我們選擇的原因。舉例來說，DUPIXENT 需要非常龐大的生物製劑產能，我們正在建置。在適當的時間點，它就會準備好交付。接著我們也有利基產品，我們預期會有兩到三個競爭對手。

So if you look at overall in the next 10 years, our portfolio would be probably 70% would be niche, about 30% would be the large molecule that we must have to offer a complete package to the customers. So that is how the portfolio makes very well and obviously, the IP driven, a lot of strategy work goes behind it for the last 10 years, what Kashiv has done, and we love the portfolio. And execution is going to be the key, which Kashiv has executed over the last 25 years. We will bring the same rigor to execute this big platform on the biologics.

所以如果你看整體未來 10 年，我們的產品組合大概 70% 會是利基產品，約 30% 會是我們必須提供的大分子產品，以便為客戶提供完整的方案。因此這樣的組合配置非常合理；而且很明顯地，這是以智慧財產（IP）驅動的，背後有大量策略工作，是 Kashiv 過去 10 年所做的，我們很喜歡這個產品組合。而執行將是關鍵，Kashiv 在過去 25 年已經展現了執行力。我們會以同樣的嚴謹度，在生物製劑這個大型平台上落實執行。

Your second question on how do I think about US commercialize, I answered most of the products. We will be marketing Amneal directly. We already have a long-standing relationship with big buyers such as CVS, Express Scripts, Cigna, Optum, UnitedHealth. These three are about 80% of the market.

你第二個問題是我如何看待美國商業化，我在大多數產品上已經回答了。我們會由 Amneal 直接進行行銷。我們與 CVS、Express Scripts、Cigna、Optum、UnitedHealth 等大型買方已建立長期合作關係。其中這三家約占市場的 80%。

We also enjoy a great relationship with smaller customers. So we're well set to commercialize products in the United States with a broad portfolio of small molecule. Don't forget that plays a role as well. It's the same people, same relationship, same trust that we have established. If you ask the Red Oak of the world or Walgreens of the world, they would rank Amneal as the most strategic, the best platform, best values, the most complicated products that we come up with and create a massive patient access at affordable prices. We intend to do the same with biosimilars.

我們也與較小型客戶維持非常好的關係。因此，憑藉廣泛的小分子產品組合，我們已充分準備好在美國商業化產品。別忘了，這也扮演著重要角色。同樣的人、同樣的關係、同樣的信任，都是我們建立起來的。如果你去問 Red Oak 或 Walgreens 這些業者，他們會把 Amneal 評為最具策略性、平台最佳、價值最佳的公司之一；我們推出並打造最複雜的產品，並以可負擔的價格大幅提升病患可近性。我們也打算在生物相似藥上做同樣的事。

International, our strategy has been clear. India, we have started marketing on our own, mostly the unmet need on the branded side and biosimilars. Rest of the world, we enjoy great partnership, as Amneal, Kashiv has also built great partnership with companies as well, which will be disclosed in the near future.

在國際市場方面，我們的策略一直很清楚。在印度，我們已開始自行行銷，主要聚焦於品牌端的未被滿足需求以及生物相似藥。至於世界其他地區，我們以 Amneal 的身分享有很好的合作夥伴關係；Kashiv 也與多家公司建立了很好的合作關係，相關資訊將在不久的將來揭露。

So I'm a big believer in a partnership model. So you can -- there is a biosimilar void. There's 118 biosimilars. How do we deliver as an industry on all of that. So partnership will make great sense, and we don't intend to have boots on grounds in Europe or South America or Canada, that's not where we are focused on.

所以我非常相信夥伴合作模式。你可以看到——生物相似藥存在一個缺口。目前有 118 個生物相似藥。我們作為產業要如何把這些都交付落地？因此合作夥伴模式非常合理；而且我們不打算在歐洲、南美或加拿大派駐在地團隊，那不是我們的重點。

We are solely focused on delivering biosimilars at scale, staying in the molecule for a long time, be a champion in America as we have a stated, goal is America's number 1 affordable medicines company, and we are on our way to get there, maybe 2030, '32, we have multi-decade strategy. So we are completely focused and internationally, great partners. We look forward to work with them.

我們唯一的重點是以規模化交付生物相似藥，長期深耕特定分子，在美國成為領導者；正如我們所宣示的目標——成為美國第一的可負擔藥品公司——我們正朝著這個方向前進，也許在 2030 年、2032 年達成；我們有跨數十年的策略。因此我們完全聚焦於此；在國際市場方面，則有很好的合作夥伴。我們期待與他們合作。

New -- the last one, I'm sorry, is a long answer, but I'm so excited. The new combined company, what is the most exciting thing. So let's go back. I mean, our core business is performing at a full throttle, it -- the women's health, the hormonal patches demand has gone up, the inhalation products demand, ophthalmic products demand, they're all at a high level. And also the small molecules LOEs are going to double in the next five years than it had for the last five years. So tremendous growth opportunity in core business by itself.

新的——最後一個問題，抱歉，答案會比較長，但我真的很興奮。新的合併公司，最令人興奮的是什麼？我們回到原點。我的意思是，我們的核心業務正以全速運轉——女性健康、荷爾蒙貼片的需求上升；吸入劑產品需求、眼科產品需求也都處於高檔。此外，小分子產品的專利到期（LOE）在未來五年將是過去五年的兩倍。因此，核心業務本身就有巨大的成長機會。

Second, our specialty brands, very exciting. You saw the CREXONT data, amazing. I mean we're getting words from our partners in Europe and India that this would become a first-line therapy because they've been using 40 years old technology platform. The product was made 40 years ago, IR product, Sinemet, which gives you off time every two hours, three hours, you think of a life of a Parkinson's patient. CREXONT is the best therapy out there for maintaining the daily lives. So very excited about CREXONT and seeing a great outcome on Brekiya. It's a much-needed product, useful product for cluster headache patients and severe migraine patients.

第二，我們的專科品牌也非常令人振奮。你看到了 CREXONT 的數據，太驚人了。我的意思是，我們從歐洲與印度的合作夥伴那裡得到回饋，認為它將成為第一線治療，因為他們一直使用的是 40 年前的技術平台。那個產品是 40 年前做出來的 IR 產品 Sinemet，每兩小時、三小時就會出現 off time；你想想帕金森氏症患者的生活。CREXONT 是目前維持日常生活最好的治療方案。所以我們對 CREXONT 非常興奮，也看到 Brekiya 有很好的結果。這是一個非常需要的產品，對叢集性頭痛患者與重度偏頭痛患者都很有用。

The third, GLP-1 partnership with Pfizer. As we all know, GLP market is going to keep growing. It's going to become life setting. So tremendous capacity would be -- and capability would be required. This is what we are building with Metsera, then it's with Pfizer.

第三，與輝瑞（Pfizer）的 GLP-1 合作夥伴關係。眾所周知，GLP 市場會持續成長。它將成為生活型態的設定（life setting）。因此將需要龐大的產能——以及能力。這正是我們與 Metsera 一起建置的，接著再與輝瑞合作。

We enjoy a great relationship with Pfizer, a win-win situation, global markets, global demand. We have 18 countries, emerging countries, including India, we've been given the rights to market. Pfizer's branded products, which came from Metsera portfolio. That's a completely unique strategy than fighting over the generics at such a low prices that's been out there in -- just started in India and rest of the world.

我們與輝瑞的關係非常好，這是雙贏的局面，面向全球市場、全球需求。我們在 18 個國家（新興市場國家，包括印度）獲得了行銷權利。可行銷輝瑞的品牌產品，而這些產品來自 Metsera 的產品組合。這是一個完全不同於在印度及世界其他地區、以極低價格去爭奪學名藥市場的獨特策略。

And we believe this is consumer products, everybody would want less side effect, longer duration, which potentially Pfizer products delivers. And the last one, as we've been talking on this call, is all about biosimilars, huge growth. We've been saying that this is the inflection point. The providers are excited. The 80% now turns into biosimilars.

我們相信這是消費者型產品，大家都希望副作用更少、作用時間更長，而輝瑞的產品可能可以做到這一點。最後一點，如同我們在這通電話中一直談到的，就是生物相似藥——巨大的成長。我們一直說這是拐點。醫療服務提供者很興奮。現在 80% 轉向生物相似藥。

The insurance company, the coverage is becoming better and better. CMS has keep pushing for it. FDA has reduced the regulatory requirements. So this is the perfect time that we integrate this platform and deliver three to five biosimilars develop and file and commercialize for many years to come. And it also opens up the opportunity for bispecifics, right, the fusion proteins and in the future, ADC as well. So if you -- this is why it's so important for Amneal to now have a complete platform, small molecule platform, and large molecule platform. Long answer, but I hope it was helpful, Matt.

保險公司的給付範圍正變得越來越好。CMS 一直在推動。FDA 已降低監管要求。因此，現在正是我們整合這個平台、並在未來多年持續開發、申報（file）與商業化三到五個生物相似藥的最佳時機。而且這也開啟了雙特異性抗體的機會，對吧，還有融合蛋白，未來也包括 ADC。所以如果你——這就是為什麼 Amneal 現在擁有完整平台如此重要：小分子平台，以及大分子平台。答案很長，但希望對你有幫助，Matt。

Les Sulewski, Truist Securities.

Les Sulewski，Truist Securities。

Congrats on the transaction. So you noted the capacity scaling from 26,000 liters to 75,000 liters. How does this compare to some of your peers? And what's the magnitude of dollar spend to get there? And separately, would you say this is rightsized for that business moving forward? And do you see a further need for capacity expansion beyond the 75,000 liters?

恭喜完成這筆交易。你們提到產能將從 26,000 公升擴增至 75,000 公升。這與你們的一些同業相比如何？要達到這個規模，資本支出金額大概是多少？另外，你們會說這樣的規模對未來該業務而言是合適的嗎？以及你們是否認為在 75,000 公升之上仍有進一步擴產的需求？

And then second, on the gross margin profile, maybe just walk us through the puts and takes around 1Q and how does the remainder of this year look? And then over the long run, how should we think about the margin profile now that the biosimilars business will be integrated?

第二個問題，關於毛利率概況，能否帶我們梳理一下第一季的利多與利空因素，以及今年剩餘時間的走勢如何？再從長期來看，隨著生物相似藥業務整合進來，我們應該如何看待毛利率概況？

Great. Chintu and I will take the first one and pass it to Tasos for the second one. So Kashiv has built the platform manufacturing sites over the last several years, which is -- which coincides with the product approvals timing. So XOLAIR being first, we will be in manufacturing Piscataway, New Jersey and also the backup site is India as well for global supply. So all key molecules will have two sites, US, which, as you know, we are a US champion. We always believe in US manufacturing. So we keep expanding US manufacturing, and we only have a site in Chicago with Kashiv acquisition, which is for E. coli. So the current capacity is sufficient for first few launches.

好的。Chintu 和我先回答第一個問題，第二個問題再交給 Tasos。Kashiv 在過去幾年建置了平台式製造廠區，而這也—也與產品核准的時點相吻合。因此 XOLAIR 作為第一個產品，我們將在新澤西州 Piscataway 進行製造，並且在印度也有備援廠區以供全球供應。所以所有關鍵分子都會有兩個廠區：美國—如你所知，我們是美國的領導者。我們一向相信美國製造。因此我們持續擴充美國製造產能；而透過收購 Kashiv，我們在芝加哥也有一個廠區，用於大腸桿菌（E. coli）。所以目前的產能足以支應前幾個產品上市。

And then over '27, '28, '29, we're expanding to 75,000 liter, which is, again, matches with the pipeline execution and pipeline approval and launch timing. That is how we see the capacity expansion. And it will be a good problem to have from 2030, '31 to keep expanding. Once we have the infrastructure in the same site, we can expand another -- keep expanding 25,000 liter -- another 25,000 liters as we need, we are always smart about this. We'll keep expanding the capacity. So we never would have issue with capacity. I'll pass it to Chintu to give more lights to this.

接著在 2027、2028、2029 年，我們會擴增到 75,000 公升；同樣地，這也與研發管線的推進、管線核准以及上市時程相匹配。這就是我們看待產能擴張的方式。而從 2030、2031 年開始若需要持續擴充，那將會是個「好問題」。一旦我們在同一廠區具備基礎設施，就可以再擴—視需要持續擴增 25,000 公升—再增加 25,000 公升；我們在這方面一向很精明。我們會持續擴充產能。因此我們不會有產能不足的問題。我把時間交給 Chintu，請他補充更多說明。

So we have perfectly sized the capacity, and it's not only about how many thousands of liters, it's also about how you design and the number of bioreactors because you need flexibility in your manufacturing and for the execution of the filing products. So I think that's a key differentiator that how we have thought through that on a long-term basis to cater to our goals of filing a few biosimilars every year and the same time also commercially to make sure that we have the excess capacity. And we are -- we have diversified our supply chain from US and India perspective also.

所以我們把產能規模配置得非常到位；而且不只是幾萬公升的問題，也關乎你如何設計以及生物反應器的數量，因為你需要在製造與申報產品的執行上具備彈性。我認為這是一個關鍵差異化：我們如何以長期角度把這件事想清楚，以支撐我們每年申報幾個生物相似藥的目標，同時在商業化層面也確保我們有多餘產能。此外，我們也從美國與印度的角度分散了供應鏈。

So if it's a cost sensitive product, we will have enough capacity in India and also in US. So I think we are positioned well to cater to all the 20 products that we have and we have also considered this as a global capacity. So it's not only US specially, we are playing globally in this market. So we are pretty comfortable with the 20 products having 75,000 liters.

因此若是成本敏感型產品，我們在印度以及美國都會有足夠產能。我認為我們已具備良好定位，可支應我們現有的 20 個產品，而且我們也把這視為全球產能配置。所以不只是特別針對美國，我們是在全球市場競爭。因此，對於 20 個產品搭配 75,000 公升產能，我們相當有信心。

It's all about the design and how we have thought through that. And we have taken under consideration good market share. So that's also there. About the spend, it's about $30 million, $50 million a year, we'll be spending for next two, three years on the CapEx to get to the 75,000 liter.

重點在於設計，以及我們如何把這件事想透。我們也把可觀的市占率納入考量。所以這也是其中一部分。至於支出，大約每年 3,000 萬到 5,000 萬美元；為了達到 75,000 公升，我們在接下來兩到三年會投入這些資本支出（CapEx）。

And Les, this is Tasos. Around gross margin. So I'll just speak in annual terms. So if you think about our gross margin in 2025 full year total company, we were at 42.9%. So let's call it 43%, and my gut feel is I think we will finish 2026 at about 45%. So at least at 200 -- we're aiming at a 200-basis-point expansion. And that's going to come -- that's going to be driven, a, by all the business units. So our affordable medicines margins will continue to expand as we have continued to evolve the pipeline to more and more complex products with higher price points, right? You've been hearing this from us for the last six years now, number 1.

Les，我是 Tasos。關於毛利率。我先用年度口徑來說明。如果你看我們 2025 年全年、全公司口徑的毛利率，是 42.9%。就算 43%，而我直覺認為 2026 年我們大概會以約 45% 作收。所以至少—我們目標是擴張 200 個基點。而這將會—主要由以下因素驅動：a，所有事業單位共同貢獻。我們的平價藥品（affordable medicines）毛利率將持續擴張，因為我們持續把產品管線演進到越來越複雜、定價更高的產品，對吧？過去六年你們一直聽到我們這樣說，這是第一點。

Number 2 is we talked about our conscious decision to increase the gross margins in our AvKARE business, which has been -- that acquisition has been a spectacular success and by focusing more on the government, at the expense of the low-margin distribution business. So that continues to pay dividends.

第二點，我們談過在 AvKARE 業務上提高毛利率是我們有意識的決策；那筆收購非常成功，透過更聚焦政府端業務，並在一定程度上犧牲低毛利的配銷業務。因此這項策略持續帶來成果。

And then finally, in our specialty business, which already has low 80s, 81%, 82% gross margins kind of continue to drive that adoption. So those have been the drivers why our gross margin this year should be at about 45% compared to about 43% last year.

最後，在我們的專科（specialty）業務方面，本來毛利率就已在 80% 出頭，大約 81%、82%，我們會持續推動採用與滲透。因此，這些就是為什麼我們今年毛利率應該約 45%，相較去年約 43% 的驅動因素。

As you think over the course of time, margins have more room to grow, more room to grow beyond the 45%. If you were here about five, six years ago, you will have heard Chirag and Chintu talking about having gross margins in the old days, almost 50%. So this is where we are driving directionally over the next 10 years. So it takes some time to get there, but we see another -- over the next three to four years, we're looking at the 45% gross margin to be closer to, call it, 47% gross margin as the portfolio continues to be driven by biosimilars, which have a higher price point than the rest of the business.

從時間拉長來看，毛利率還有成長空間，還能在 45% 之上繼續提升。如果你在五、六年前就在這裡，你會聽到 Chirag 和 Chintu 談到在更早以前，我們的毛利率幾乎接近 50%。這就是我們未來 10 年在方向上要推進的目標。達到那裡需要一些時間，但我們看到另一個—在未來三到四年，我們希望毛利率能從約 45% 更接近、姑且稱之為 47%，因為產品組合將持續由生物相似藥帶動，而生物相似藥的定價高於公司其他業務。

David Amsellem, Piper Sandler.

David Amsellem，Piper Sandler。

So I have a few. First, can you just comment and elaborate on the insider ownership of Kashiv? That's number one.

我有幾個問題。第一，能否請你們評論並進一步說明 Kashiv 的內部人持股情況？這是第一點。

Number two is why provide long-term revenue EBITDA targets, not just '27, but also out to 2030? What was the rationale there? And just remind us is the EBITDA margin expansion that you're factoring in between 2027 and 2030, is that -- how much of that is a function of just the elimination of the shared economics on biosims?

第二，為什麼要提供長期的營收與 EBITDA 目標，不只是到 2027 年，還延伸到 2030 年？背後的考量是什麼？另外請提醒我們，你們在 2027 到 2030 年之間所假設的 EBITDA 利潤率擴張，其中有多少—是單純來自於取消生物相似藥的共享經濟（shared economics）？

And then the last question is, how much of your revenue base by 2030 do you expect will be from biosims?

最後一個問題是，到 2030 年你們預期營收基礎中有多少會來自生物相似藥（biosims）？

David, I'll take question number 2 and number 3. If you can just -- can you just repeat question number one for a second, if you don't mind?

David，我來回答第 2 題和第 3 題。如果可以的話——你能不能把第 1 題再重複一次，麻煩你？

Yes, the insider ownership of Kashiv.

好的，關於 Kashiv 的內部人持股。

Insider ownership of Kashiv. Okay. Got it. Okay. So well, I'll take the first one. I'll start with the first one. So insider ownership of Kashiv, you can see it essentially in our proxy, which has been owned by the Amneal Group, which has been also a big shareholders at Amneal since the beginning of time. So ownership includes of the Amneal Group, includes both our CEOs who've always been transparent of that as well as people who have been investors in Kashiv and -- investors of Kashiv and also at Amneal for a very long time, and key contributors to what we have built now, which is a great company. So that kind of thing addresses question number 1, hopefully.

Kashiv 的內部人持股。好的。了解。好的。那我先回答第一題。我先從第一題開始。關於 Kashiv 的內部人持股，你基本上可以在我們的委託書（proxy）中看到；該公司一直由 Amneal 集團持有，而 Amneal 集團自公司創立以來也一直是 Amneal 的大股東。因此，持股結構包含 Amneal 集團，也包含我們兩位執行長（他們對此一向很透明），以及長期以來投資 Kashiv、也投資 Amneal 的投資人，還有對我們如今所打造的這家優秀公司作出關鍵貢獻的人。所以這應該就回答了第 1 題，希望如此。

Number 2 is no CFO that I know likes to provide long-term guidance because it's a Catch-22 as lot of things can happen over the course of time. Having said that, and you got to -- I think you know us long enough to know, we take our long-term guide and financial commitments incredibly, incredibly seriously. So for us to provide long-term guidance, we had to feel pretty confident on our ability to deliver on those commitments, number 1.

第 2 題是：據我所知，沒有哪位 CFO 喜歡提供長期指引，因為這是一個兩難（Catch-22），時間拉長會發生很多事。話雖如此——而且你也得——我想你認識我們夠久就知道，我們對長期指引與財務承諾是非常、非常認真的。所以我們要提供長期指引，第一點，我們必須對自己交付這些承諾的能力相當有信心。

Number 2, I think it speaks to the tremendous amount of diligence we have done in this acquisition, which probably expand at least a year's worth of work by tens of people in our R&D group, in our legal group, in our business development group, in our financial group and the commercial group to convince me and convince us as a management team to lay those numbers out for our investors.

第二點，我認為這也反映出我們在這次收購上做了大量的盡職調查；這可能至少是一整年的工作，由我們研發團隊、法務團隊、商務開發團隊、財務團隊以及商業團隊的數十人共同完成，才讓我、也讓我們管理團隊相信並願意把這些數字攤開給投資人看。

The final thing is, I would say, why provide long-term guide, to us, it provides a focal point by which we focus 8,000 employees at Amneal and now our brand-new colleagues at Kashiv. So everyone, all of our 8,000-plus employees are singularly focused to a set of financial metrics, so it eliminates ambiguity. So this is what's behind why provide those targets. And also you got to assume we're being prudently conservative, right? No management team, at least that I know, wants to put out numbers which they are at risk of missing. So that's kind of how we thought about and why we provide those long-term targets.

最後一點，我會說，為什麼要提供長期指引？對我們而言，它提供了一個焦點，讓 Amneal 的 8,000 名員工，以及現在 Kashiv 的全新同仁都能聚焦。因此，我們 8,000 多名員工都能一致聚焦在一組財務指標上，從而消除模糊空間。這就是我們設定這些目標背後的原因。另外你也得假設我們是審慎保守的，對吧？至少就我所知，沒有管理團隊會想公布一些有可能達不到的數字。所以這大致就是我們如何思考、以及為什麼提供這些長期目標。

Now in terms of revenue and EBITDA expansion, it's a combination. It's a combination of both. I don't have the exact percentages, right? A lot of how much of that is a new acquisition versus how much of that is the existing business. As I mentioned before, we have an existing business.

至於營收與 EBITDA 的擴張，這是綜合因素。兩者都有。我沒有精確的百分比，對吧？也就是其中多少來自新收購、多少來自既有業務。如我先前提到的，我們本來就有既有業務。

You look at our affordable medicines, every part of our business is growing. So we are doing this deal, not because we need to, because we think this is the right deal to do at the right time with the right risk parameters to drive growth for this business in 2030 and beyond.

你看我們的平價藥品（affordable medicines），我們業務的每個部分都在成長。所以我們做這筆交易，不是因為不得不做，而是因為我們認為這是在對的時間、以對的風險參數做對的交易，來推動這項業務在 2030 年及之後的成長。

So you look at our affordable business, and that business is growing this year. We expect it to grow 7% to 8%. That growth will continue, and you can model this and biosimilars will add to that, right? And then in terms of an EBITDA basis, Q1 EBITDA was up 19%, right? Last year's EBITDA growth was 10%, this year.

所以你看我們的平價業務，那個業務今年在成長。我們預期會成長 7% 到 8%。這個成長會持續，而你可以把它建模，而且生物相似藥也會在此基礎上增加，對吧？另外以 EBITDA 來看，第一季 EBITDA 成長了 19%，對吧？去年 EBITDA 成長是 10%，今年也是。

So the base business that is growing at least adjusted EBITDA 10%. We expect this to continue and add on -- the additional add-on we expect to come on biosimilars. So that's how we think of it. It is a highly derisked long-term forecast that is based on the growth of the existing business plus the acquisition and it's conservative in nature. So hopefully, that addressed some of your questions.

所以基本盤業務至少在調整後 EBITDA 上成長 10%。我們預期這會持續，並且再加上——我們預期生物相似藥會帶來額外的增量。所以我們是這樣看待的。這是一個高度去風險化的長期預測，基於既有業務的成長加上這次收購，而且本質上偏保守。希望這回答了你的一些問題。

Yes. How much of your business do you think is going to be biosimilars? Like what's the revenue base going to be in 2030 --

是的。你認為你們的業務中有多少會是生物相似藥？例如到 2030 年營收基礎會是——

So --

所以——

Footprint now, yes.

目前的版圖，是的。

Yes. So if you think about 2030, for example, the guidance we're providing is between $4.3 billion and $4.5 billion, probably about $1 billion -- a little over $1 billion, $1 billion to $1.3 billion, that's going to be biosimilars.

是的。所以如果你以 2030 年來看，例如我們提供的指引是 43 億到 45 億美元之間，其中大概 10 億美元——略高於 10 億美元，約 10 億到 13 億美元——會來自生物相似藥。

Chris Schott, JPMorgan.

JPMorgan 的 Chris Schott。

Just two for me. Maybe just first, a bigger picture question on biosimilars. Can you just talk a little bit more about how you see the competitive landscape evolving as we approach this very large cycle of biologic patent expirations? I know you mentioned there's no clear leader in the space, but do you anticipate there's going to be a more meaningful consolidation of share and there's going to just be a handful of players? Or will this remain a more fragmented market as a whole?

我這邊兩個問題。首先可能是一個更宏觀的生物相似藥問題。你能否再多談一點，隨著我們接近這一波非常大的生物製劑專利到期週期，你如何看待競爭格局的演變？我知道你提到目前沒有明確的領導者，但你是否預期市占會出現更有意義的整併，最後只剩少數幾家玩家？還是整體而言仍會是一個較為分散的市場？

And the second one for me is just on a specific product on lanreotide, the Somatuline Depot. Can you just talk a little bit about that opportunity as we think about 2026 in terms of market dynamics and competitive landscape and just how meaningful of a product that could represent for Amneal?

第二個問題是關於一個特定產品：lanreotide，也就是 Somatuline Depot。你能否談談我們在看 2026 年時，該機會在市場動態與競爭格局方面的情況，以及它對 Amneal 可能代表多大的重要性？

Yes. Thank you, Chris. Competitive landscape on biosimilars, as we know, the vertically integrated players are taking more market share. Amgen, obviously, one brand company that is still investing in biosimilars. Rest of the brand companies have moved out of favor for biosimilars, as you know, they are more obviously back to the innovative medicines.

是的。謝謝你，Chris。關於生物相似藥的競爭格局，如我們所知，垂直整合的玩家正在取得更多市占。Amgen 顯然是一家仍在投資生物相似藥的品牌藥公司。其他品牌藥公司如你所知，對生物相似藥的投入已不再受青睞，他們更明顯地回到創新藥領域。

So that leaves Sandoz obviously clear global leader at this point and a great company. Celltrion is coming in, is a -- from -- a South Korean company, which is expanding in the United States and globally and building a large vertically integrated platform. Samsung is doing both out-licensing mainly and concentrating also different division on biosimilars. India's Biocon has been in the biologics for over 40 years. So they're already in the United States market.

因此，目前很明顯的全球領導者是 Sandoz，而且是一家很優秀的公司。Celltrion 正在進入市場——是一家來自南韓的公司——正在美國及全球擴張，並打造大型的垂直整合平台。Samsung 主要在做對外授權（out-licensing），同時也在不同事業部聚焦生物相似藥。印度的 Biocon 在生物製劑領域已經超過 40 年。所以他們已經在美國市場。

And then Kabi with mAbxience ownership and their own, we see them as a vertically integrated player. So the way it would expand is -- this is why it's an inflection point that we, as Amneal got the platform or getting a platform with the manufacturing capacity, with the pipeline that we execute over the next five to seven years. It requires a lot of manufacturing infrastructure, a lot of R&D infrastructure, number of years, even with FDA's Phase 3 gone, still will be five-plus years from the timing of starting the clone development all the way to the filing and approval and then the IP negotiation settlement. All those things would take five, seven years.

接著，Kabi 透過持有 mAbxience 的股權以及其自身能力，我們將其視為一家垂直整合的參與者。因此，其擴張方式會是——這也是為什麼這是一個拐點：我們 Amneal 取得了這個平台，或正在取得一個具備製造產能、並可在未來五到七年執行之產品管線的平台。這需要大量的製造基礎設施與研發基礎設施，以及多年時間；即便 FDA 的第三期（Phase 3）已取消，從開始克隆開發一路到申報、核准，然後再到智慧財產權（IP）談判和解，時間仍會超過五年。所有這些事情都需要五到七年。

So -- and you can't see like in a small molecule, you have 50 companies jumping in from India and China. We don't see that. We see a few companies will come from India, a few maybe from China, but they all have to build these US-oriented infrastructure or regulated markets, which is a different ball game than you've been producing biologics for the emerging markets, because the requirements of FDAs are much at higher standards than those other countries. And Amneal builds everything first with US in mind.

所以——而且你不會像小分子那樣，看到有 50 家公司從印度和中國一窩蜂跳進來。我們沒有看到那種情況。我們看到的是：會有少數公司來自印度，少數可能來自中國，但它們都必須建立面向美國的基礎設施或受監管市場的能力；這跟你一直在為新興市場生產生物製劑是完全不同的遊戲，因為 FDA 的要求標準遠高於那些國家。而 Amneal 一開始建置所有能力時，都是以美國為優先考量。

So yes, there will be more competitors. The large molecules like KEYTRUDA, OPDIVO, you will see 5 to 10 competitors. Some would be partnered, and niche, this is why we, Kashiv and Amneal will be focused on is in niche molecules where we will see two to three competitors. So that's how we see the competitive landscape, maybe 8 to 10 players. There are 118 molecules to go after.

所以是的，競爭者會變多。像 KEYTRUDA、OPDIVO 這類大分子，你會看到 5 到 10 個競爭者。其中一些會是合作夥伴模式、且偏利基；這也是為什麼我們 Kashiv 與 Amneal 會聚焦在利基分子上，在那裡我們預期只會看到 2 到 3 個競爭者。所以這就是我們對競爭版圖的看法，可能有 8 到 10 個玩家。可追逐的分子有 118 個。

Big biosimilar void is there. So that is a large, large number of products to work on and not everybody can do every product. As we said, our capacity capability is three to five per year. Chintu, do you want to add anything?

大型生物相似藥的缺口確實存在。因此，這是一個非常、非常龐大的產品數量可以投入開發，而且不是每個人都能做每一個產品。如我們所說，我們的產能與能力是一年 3 到 5 個。Chintu，你要補充什麼嗎？

I mean there's a lot of high barriers of entry, and science, it's much more complicated than the small molecules. It will cost close to $50 million to $75 million per product. So there are lots of barriers. So I think it still will remain not that competitive plus as Chirag stated, it takes five, seven years for a new player to build this platform and have the manufacturing and development expertise and capacity. At Kashiv, we have a fantastic group of 600-plus people.

我的意思是，進入門檻很高，科學層面也比小分子複雜得多。每個產品的成本接近 5,000 萬到 7,500 萬美元。所以有很多障礙。因此我認為競爭仍不會那麼激烈；再加上如 Chirag 所說，新玩家要建立這個平台、具備製造與開發的專業與產能，需要五到七年。在 Kashiv，我們有一個非常出色、超過 600 人的團隊。

And that experience, I think, gives us the confidence of this three to five biosimilar. So competition, as Chirag stated, would be these four, five players might be vertically integrated, but still is largely a space for somebody to be a leader and the Amneal will be a leader by 2030.

而我認為，這些經驗讓我們對一年 3 到 5 個生物相似藥的能力更有信心。所以競爭方面，如 Chirag 所述，可能會有四、五個玩家是垂直整合的，但整體而言仍有很大空間讓某家公司成為領導者，而 Amneal 將在 2030 年前成為領導者。

And lanreotide, Chris, is -- the market dynamics changed. There was -- Cipla was in the market, had some contract manufacturing issues, so they are no longer in the market. It leaves it only with brand and the product is in high demand. We're getting calls from everybody. So we have requested FDA to expedite the approval and they're working on it, and we could be the first, again, the -- I'm sorry, it's a small molecule, generic lanreotide in the market, and we will supply and create another access for the hospitals and clinics as soon as possible.

至於 lanreotide，Chris，市場動態已經改變。之前——Cipla 在市場上，但他們遇到一些委託製造（contract manufacturing）問題，所以他們已不在市場上。這使得市場只剩下原廠，而該產品需求很高。我們接到各方的來電。因此我們已請求 FDA 加速核准，他們正在處理；而我們可能會再次成為第一個——抱歉，這是小分子——在市場上的 lanreotide 學名藥（generic），我們將盡快供應，為醫院與診所創造另一個取得管道。

And this is also global. So we have a pending approval in Europe also, and it's a highly complex product. It's a drug device combination peptide. So we are looking forward to this product and its opportunity.

而且這也是全球性的。我們在歐洲也有待核准案，且這是一個高度複雜的產品。它是藥物—器材組合的胜肽產品。因此我們非常期待這個產品及其機會。

Glen Santangelo, Barclays.

Barclays 的 Glen Santangelo。

Just a couple for me. Chirag, I mean, I think everyone would generally agree strategically that a deal like this kind of makes sense. But I'm kind of curious to get your perspective on the operational complexities of sort of what's involved here. Because if you look at the -- we were just talking to Chris' question about the evolution of the competitive landscape. A number of the other players have decided to go more in the partnership licensing route versus the vertical integration route. And maybe that's a function of how complicated or operationally complex it is. And so I'm kind of curious if you worry at all about increasing the risk profile of the company in that way.

我這邊有兩個問題。Chirag，我想大家在策略上普遍會同意，這樣的交易大致上是合理的。但我有點想聽聽你對於其中涉及的營運複雜度的看法。因為如果你看——我們剛剛在回應 Chris 的問題時談到競爭版圖的演變。其他一些玩家選擇走合作授權（partnership licensing）路線，而不是垂直整合路線。也許這反映了它有多複雜、或在營運上有多複雜。所以我想知道，你是否擔心這樣會提高公司的風險輪廓。

And then maybe secondarily, I wanted to talk about the 2027 EBITDA guidance that you put out today. And I'm guessing you kind of realize that, that number is a decent amount below what the Street was already forecasting for fiscal '27 and kind of implies some deceleration in the EBITDA growth rate in '27 versus '26. And just sort of given the $400 million to $500 million in synergies we sort of talked about, you had a couple of partnership deals that seem like they're on track and maybe you'll have full ownership of them by the time they come to fruition. I'm just trying to reconcile all the pieces that you've laid out here as it relates to how soon we may see those synergistic benefits in '27 and beyond.

另外第二個問題，我想談談你們今天提出的 2027 年 EBITDA 指引。我猜你也意識到，那個數字明顯低於華爾街原本對 2027 財年的預測，並且某種程度上意味著 2027 年相較 2026 年的 EBITDA 成長率會放緩。而考量到我們談到的 4 億到 5 億美元協同效益（synergies），你們有幾個合作案看起來進展順利，而且到它們開花結果時，你們可能已擁有其完整所有權。我只是想把你在這裡提出的各個拼圖串起來，理解我們在 2027 年及之後，可能多快能看到那些協同效益的貢獻。

Thank you, Glen. So let me take the first one. I'll pass it to Tasos for the second question. So the first one, partnering versus full economics or vertically means vertically integrated. Yes, it is complex. This is why it took 10 years for Kashiv to build this platform with significant investment. So this is why we believe it be competitive light compared to obviously the small molecule.

謝謝你，Glen。我先回答第一個。第二個問題我會交給 Tasos。第一個，合作夥伴模式對比完整經濟利益（full economics）或垂直化，這裡的垂直化指的是垂直整合。是的，這很複雜。這也是為什麼 Kashiv 花了 10 年、投入大量資本才建立起這個平台。因此我們相信，相較於小分子，這個領域的競爭會相對較不激烈。

And why you can take the large few molecules, right, who could stay in the market, who could take the leadership position and stay all the way until the molecule needs to be delivered and produced. So if we have -- first of all, it gives you full economics. So your margin expands, you have full freedom of selecting products and it's not easy to in-license 20 products. We have 20 products biosimilar basket, and we're going to add more in coming years. So that freedom, the full economics in the United States market, it makes sense to be completely vertically integrated.

而且為什麼你可以選擇少數幾個大型分子，對吧，哪些公司能留在市場、能取得領導地位，並一路維持到該分子需要交付與生產為止。所以如果我們——首先，它能讓你取得完整的經濟利益。因此你的毛利率會擴張，你在選擇產品上有完全的自由，而且要授權引進（in-license）20 個產品並不容易。我們有 20 個生物相似藥的產品組合（basket），而且未來幾年還會增加更多。所以在美國市場，這種自由度與完整經濟利益，使得完全垂直整合是合理的。

As I stated before, Glen, that it would -- the partnering would -- is great. And in international market, we look to partner and Kashiv already has partnership with the key players globally who are well set globally. So I see the combined model, but mostly the companies that would be successful if you look back in 2030 or '35 are going to be all vertically integrated.

如我先前所說，Glen，合作——合作夥伴模式——也很棒。在國際市場，我們會尋求合作，而 Kashiv 已經與全球主要玩家建立合作關係，這些夥伴在全球布局完善。所以我看見的是一個結合式的模式，但如果你回頭看 2030 或 2035 年，最成功的公司大多都會是完全垂直整合的。

They will not be -- just like in small molecule, there are not any companies that have survived being just the marketing companies. We got to do a lot more than that because the real, real complications is the R&D, is the IP, is manufacturing. I think the PBMs and private labels are making the marketing and sales easier, which is how it should be. I hope that answers the first question. You can -- may have a follow-up, but let me pass it to Tasos.

它們不會——就像在小分子領域一樣，沒有任何公司能在只做行銷公司的情況下存活下來。我們必須做得更多，因為真正、真正複雜的部分在於研發、智慧財產權（IP）以及製造。我認為PBM與自有品牌正在讓行銷與銷售變得更容易，這也正是應該的方向。希望這回答了第一個問題。你可以——也許還有追問，但我先把問題交給Tasos。

Glen, I love financial modeling questions. So let's kind of put things in perspective. So the first point is guidance for 2027 on EBITDA of $820 million is kind of substantially below where the Street is. I'm not sure where the Street is, number one, I think that they are about $835 million. So us providing guidance of $820 million plus compared to $835 million, I don't think it's substantially less than that, kind of point number 1. But also, obviously, we don't run our business to kind of satisfy anybody else other than us and our shareholders, kind of point number one.

Glen，我很喜歡財務建模的問題。那我們把事情放在脈絡裡看。第一點，對2027年EBITDA為8.20億美元的指引，確實比華爾街預期低不少。我不確定華爾街的數字是多少；第一，我認為大約是8.35億美元。所以我們提供8.20億美元以上的指引，相較於8.35億美元，我不覺得這是「大幅」更低，這是第一點。但同時，顯然我們經營公司並不是為了滿足除我們自己與股東之外的任何人，這也是第一點。

Point number 2, this kind of notion of kind of deceleration. This year EBITDA, right, the midpoint is at $755 million is about 10% growth versus prior year. Even if you take the low end of what we gave you for next year of $820 million, that's about 9%. So 9% versus 10%, I don't think it's a big deceleration, number 2.

第二點，關於所謂的放緩。今年的EBITDA，中位數是7.55億美元，較去年約成長10%。即使你採用我們給的明年下緣8.20億美元，也約是9%。所以9%對10%，我不認為這是很大的放緩，這是第二點。

And number 3, we feel great about growing EBITDA 9%, 10%, even absorbing a strategic deal, which is going to have some dilution next year until it becomes accretive in 2028.

第三點，我們對於EBITDA成長9%、10%感到非常有信心，即便同時吸收一筆策略性交易——該交易明年在2028年轉為增厚（accretive）之前，明年會有一些稀釋（dilution）。

So we feel great about being able to give our shareholders a view about next year of adjusted EBITDA up of about at least 9%, number one. And at the same time, fund incremental R&D, right, to maximize the opportunity here of $300 billion plus of branded products going generic over the course of time. That's kind of how we thought of it, and try to give you guidance for 2027, that's a long time away. So I think it speaks to our confidence about telling you what we think we can -- the minimum we can deliver next year. So hopefully, that gives you some perspective.

因此，我們很有信心能讓股東看到：明年的調整後EBITDA至少成長約9%，這是第一點。同時，也能投入額外的研發資金，以最大化把握未來隨時間推進、超過3,000億美元的品牌藥品轉為學名藥的機會。這就是我們的思考方式，並嘗試提供2027年的指引——那是很久以後的事。所以我認為這反映了我們的信心：告訴你們我們認為能——明年至少能交付的最低水準。希望這能提供一些觀點。

Ash Verma, UBS.

Ash Verma，瑞銀（UBS）。

This is (inaudible) from UBS. I'm just asking questions on behalf of Ash. So I have 2. The first one, and I apologize, this has been discussed before. So the first one, how do you think about the lanreotide market opportunity? It seems like there's just limited competition in this molecule. So I just wonder like how confident are you about the approval timeline in 3Q? And what will be the gating items for the launch?

我是來自瑞銀（UBS）的（聽不清）。我只是代替Ash提問。我有兩個問題。第一個問題，先說聲抱歉，這之前已經討論過。第一個是，你們如何看待lanreotide的市場機會？看起來這個分子上的競爭相當有限。所以我想問，你們對於第三季的核准時程有多大把握？以及上市（launch）的關鍵卡點會是什麼？

And then my second question on gross margin. So I think like it was discussed before the annual -- like in annual term, it's about like 45%, but in 1Q, I think this quarter it is about 48%. Does that mean we're going to see some gross margin normalization later this year? If you can give some clarification on that, that would be helpful.

第二個問題是關於毛利率。我想之前也提過，以全年來看大約是45%，但在第一季，我想本季大約是48%。這是否意味著我們會在今年稍晚看到毛利率回歸常態？如果你們能針對這點做些說明，會很有幫助。

Thank you, (inaudible) The lanreotide, the gating item is only the FDA approval. We're ready to supply, and it's a great opportunity for Amneal. I'll pass it to Tasos on the gross margin.

謝謝，（聽不清）。Lanreotide方面，唯一的關鍵卡點就是FDA核准。我們已準備好供貨，這對Amneal來說是很好的機會。毛利率的部分我交給Tasos。

Yes. Our Q1 gross margin follows for a while. It was just a record quarter, which was overall up 510 basis points versus Q1 of last year. So it's just to kind of be able the sustainability of 510 basis points is kind of hard to keep repeating quarter after quarter. So this is why I think we're being -- we have a little bit more modest gross margin expansion for the rest of the year.

是的。我們第一季的毛利率已經維持了一段時間。那只是創紀錄的一季，整體較去年第一季提高了510個基點。因此，要讓這510個基點的提升具備可持續性、並在每一季重複出現，是相當困難的。所以這也是為什麼我認為我們——對今年剩餘期間的毛利率擴張預期會稍微保守一些。

And this is why, though -- even though with a little, call it, a little bit more modest growth the rest of the year, we still feel confident that overall company gross margins this year in 2026 should be closer to 45%, 45%, maybe a little better compared to about 43% last year. Hopefully, that's helpful.

也因此——即便今年剩餘期間的成長稍微、可以說稍微更溫和一些，我們仍有信心：公司整體毛利率在今年、在2026年應該會更接近45%、45%，也許還會略好一些，相較於去年約43%。希望這有幫助。

There are no further questions at this time. I will now turn the call back to Chirag Patel for closing remarks.

目前沒有其他問題。我現在把電話會議交回給Chirag Patel做結語。

Well, thank you, everyone, and have a great day.

好的，謝謝各位，祝大家有美好的一天。

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。