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Investor releaseQuarter not tagged2026-05-27Q4 Earnings Highlights: Amneal (NASDAQ:AMRX) Vs The Rest Of The Generic Pharmaceuticals Stocks
StockStory
Q4 Earnings Highlights: Amneal (NASDAQ:AMRX) Vs The Rest Of The Generic Pharmaceuticals Stocks
Quarterly earnings results are a good time to check in on a company’s progress, especially compared to its peers in the same sector. Today we are looking at Amneal (NASDAQ:AMRX) and the best and worst performers in the generic pharmaceuticals industry. The generic pharmaceutical industry operates on a volume-driven, low-cost business model, producing bioequivalent versions of branded drugs once their patents expire. These companies benefit from consistent demand for affordable medications, as they are critical to reducing healthcare costs. Generics typically face lower R&D expenses and shorter regulatory approval timelines compared to branded drug makers, enabling cost efficiencies. However, the industry is highly competitive, with intense pricing pressures, thin margins, and frequent legal challenges from branded pharmaceutical companies over patent disputes. Looking ahead, the industry is supported by tailwinds such as the role of AI in streamlining drug development (reverse engineering complex formulations) and manufacturing efficiency (optimize processes and remove inefficiencies). Governments and insurers' focus on reducing drug costs can also boost generics' adoption. However, headwinds include escalating pricing pressure from large buyers like pharmacy chains and healthcare distributors as well as evolving regulatory hurdles. The 4 generic pharmaceuticals stocks we track reported a mixed Q4. As a group, revenues beat analysts’ consensus estimates by 4.8%. Amidst this news, share prices of the companies have had a rough stretch. On average, they are down 7.6% since the latest earnings results. Founded in 2002 and growing into one of America's largest generic drug producers, Amneal Pharmaceuticals (NASDAQ:AMRX) develops, manufactures, and distributes generic medicines, specialty branded drugs, biosimilars, and injectable products for the U.S. healthcare market. Amneal reported revenues of $814.3 million, up 11.5% year on year. This print exceeded analysts’ expectations by 0.9%. Despite the top-line beat, it was still a mixed quarter for the company with an impressive beat of analysts’ full-year EPS guidance estimates but full-year revenue guidance missing analysts’ expectations. Amneal pulled off the highest full-year guidance raise of the whole group. Still, the market seems discontent with the results. The stock is down 0.4% since reporting and curren...
Investor releaseQuarter not tagged2026-05-14Amneal Pharmaceuticals' (NASDAQ:AMRX) Solid Earnings Are Supported By Other Strong Factors
Simply Wall St.
Amneal Pharmaceuticals' (NASDAQ:AMRX) Solid Earnings Are Supported By Other Strong Factors
When companies post strong earnings, the stock generally performs well, just like Amneal Pharmaceuticals, Inc.'s (NASDAQ:AMRX) stock has recently. We have done some analysis, and we found several positive factors beyond the profit numbers. Trump has pledged to "unleash" American oil and gas and these 15 US stocks have developments that are poised to benefit. For anyone who wants to understand Amneal Pharmaceuticals' profit beyond the statutory numbers, it's important to note that during the last twelve months statutory profit was reduced by US$61m due to unusual items. It's never great to see unusual items costing the company profits, but on the upside, things might improve sooner rather than later. We looked at thousands of listed companies and found that unusual items are very often one-off in nature. And that's hardly a surprise given these line items are considered unusual. If Amneal Pharmaceuticals doesn't see those unusual expenses repeat, then all else being equal we'd expect its profit to increase over the coming year. That might leave you wondering what analysts are forecasting in terms of future profitability. Luckily, you can click here to see an interactive graph depicting future profitability, based on their estimates. Unusual items (expenses) detracted from Amneal Pharmaceuticals' earnings over the last year, but we might see an improvement next year. Based on this observation, we consider it likely that Amneal Pharmaceuticals' statutory profit actually understates its earnings potential! And it's also positive that the company showed enough improvement to book a profit this year, after losing money last year. At the end of the day, it's essential to consider more than just the factors above, if you want to understand the company properly. So if you'd like to dive deeper into this stock, it's crucial to consider any risks it's facing. For example, Amneal Pharmaceuticals has 2 warning signs (and 1 which doesn't sit too well with us) we think you should know about. This note has only looked at a single factor that sheds light on the nature of Amneal Pharmaceuticals' profit. But there is always more to discover if you are capable of focussing your mind on minutiae. For example, many people consider a high return on equity as an indication of favorable business economics, while others like to 'follow the money' and search out stocks that insiders a...
Investor releaseQuarter not tagged2026-05-08Amneal Reports First Quarter 2026 Financial Results
GlobeNewswire
Amneal Reports First Quarter 2026 Financial Results
‒ Q1 2026 Net Revenue of $723 million; GAAP Net Income of $62 million; Diluted Income per Share of $0.19 ‒ ‒ Adjusted EBITDA of $202 million; Adjusted Diluted EPS of $0.27 ‒ ‒ No Change from Preliminary Results Previously Announced on April 22, 2026 ‒ ‒ Affirms Previously Announced Increase in 2026 Full Year Guidance ‒ BRIDGEWATER, N.J., May 07, 2026 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced its results for the first quarter ended March 31, 2026. “Amneal delivered a very strong start to 2026, reflecting the strength of our diversified business and multiple growth drivers across the portfolio. Our Specialty business continues to perform exceptionally well, led by CREXONT® and the recent launch of BREKIYA® autoinjector, alongside a strong cadence of key launches in Affordable Medicines. We are entering the Kashiv transaction from a position of strength, at a time when we see an extended period of accelerated growth ahead with no shortage of opportunities across our core businesses. Combined with our very strong first quarter results, we are pleased to affirm our previously announced increase in our full year 2026 guidance,” said Chirag and Chintu Patel, Co-Founders and Co-Chief Executive Officers of Amneal. First Quarter 2026 Results Net revenue in the first quarter of 2026 was $723 million, an increase of 4% compared to $695 million in the first quarter of 2025. Specialty net revenue increased 23%, driven by key branded products, including CREXONT®, BREKIYA® autoinjector, and UNITHROID®. Affordable Medicines net revenue increased 2%, driven by strong performance of our complex portfolio, including women’s health and ADHD medicines. AvKARE net revenue declined 4% as growth in the government channel was offset by a decline in the low margin distribution channel. This continued portfolio shift drove a 750 basis point and 510 basis point increase in gross margin and adjusted gross margin, respectively, in the first quarter of 2026, compared to the prior year. Net income attributable to Amneal Pharmaceuticals, Inc. was $62 million in the first quarter of 2026 compared to net income of $12 million in the first quarter of 2025, an increase of 411%, reflecting higher revenue and gross profit. Adjusted EBITDA in the first quarter of 2026 was $202 million, an increase of 19% compared to the first quarter...
Investor releaseQuarter not tagged2026-05-08Amneal (AMRX) Q1 Earnings: Taking a Look at Key Metrics Versus Estimates (Revised)
Zacks
Amneal (AMRX) Q1 Earnings: Taking a Look at Key Metrics Versus Estimates (Revised)
For the quarter ended March 2026, Amneal Pharmaceuticals (AMRX) reported revenue of $723 million, up 4% over the same period last year. EPS came in at $0.27, compared to $0.21 in the year-ago quarter. The reported revenue represents a surprise of +1.86% over the Zacks Consensus Estimate of $709.79 million. With the consensus EPS estimate being $0.17, the EPS surprise was +63.64%. While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expectations to determine their next move, some key metrics always offer a more accurate picture of a company's financial health. As these metrics influence top- and bottom-line performance, comparing them to the year-ago numbers and what analysts estimated helps investors project a stock's price performance more accurately. Here is how Amneal performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts: Net Revenue- Affordable Medicines Segment: $423.24 million versus the two-analyst average estimate of $416.92 million. The reported number represents a year-over-year change of +2.1%. Net Revenue- AvKARE Segment: $166.02 million versus $170.49 million estimated by two analysts on average. Compared to the year-ago quarter, this number represents a -3.7% change. Net Revenue- Specialty Segment: $133.27 million versus the two-analyst average estimate of $125.26 million. The reported number represents a year-over-year change of +23.1%. View all Key Company Metrics for Amneal here>>> Shares of Amneal have returned +4.6% over the past month versus the Zacks S&P 500 composite's +9.7% change. The stock currently has a Zacks Rank #3 (Hold), indicating that it could perform in line with the broader market in the near term. (We are reissuing this article to correct a mistake. The original article, issued on April 23, 2026, should no longer be relied upon.) Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report AMNEAL PHARMACEUTICALS, INC. (AMRX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-04-23Amneal (AMRX) Q1 Earnings: Taking a Look at Key Metrics Versus Estimates
Zacks
Amneal (AMRX) Q1 Earnings: Taking a Look at Key Metrics Versus Estimates
For the quarter ended March 2026, Amneal Pharmaceuticals (AMRX) reported revenue of $723 million, up 4% over the same period last year. EPS came in at $0.27, compared to $0.21 in the year-ago quarter. The reported revenue represents a surprise of +1.86% over the Zacks Consensus Estimate of $709.79 million. With the consensus EPS estimate being $0.17, the EPS surprise was +63.64%. While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expectations to determine their next move, some key metrics always offer a more accurate picture of a company's financial health. As these metrics influence top- and bottom-line performance, comparing them to the year-ago numbers and what analysts estimated helps investors project a stock's price performance more accurately. Here is how Amneal performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts: Net Revenue- Affordable Medicines Segment: $423 million versus the two-analyst average estimate of $416.92 million. The reported number represents a year-over-year change of +2%. Net Revenue- AvKARE Segment: $166 million versus $170.49 million estimated by two analysts on average. Compared to the year-ago quarter, this number represents a -3.7% change. Net Revenue- Specialty Segment: $133 million versus the two-analyst average estimate of $125.26 million. The reported number represents a year-over-year change of +22.8%. View all Key Company Metrics for Amneal here>>> Shares of Amneal have returned +4.6% over the past month versus the Zacks S&P 500 composite's +9.7% change. The stock currently has a Zacks Rank #3 (Hold), indicating that it could perform in line with the broader market in the near term. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report AMNEAL PHARMACEUTICALS, INC. (AMRX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-04-23AMRX Announces Kashiv BioSciences Buyout, Solid Q1 Preliminary Results
Zacks
AMRX Announces Kashiv BioSciences Buyout, Solid Q1 Preliminary Results
Amneal Pharmaceuticals AMRX announced that it has entered into a definitive agreement to acquire privately held biotech company Kashiv BioSciences for up to $1.10 billion. The transaction includes $375 million in cash and $375 million in equity, plus up to $350 million in potential milestone-based payments tied to certain regulatory and commercial achievements. Kashiv is among a few companies with end-to-end biosimilars capabilities covering development, manufacturing, and a deep pipeline in the United States. The transaction is expected to be closed in the second half of 2026, subject to customary closing conditions. Simultaneously, Amneal reported preliminary first-quarter 2026 results. The company also raised its 2026 full-year EPS guidance. Let’s discuss the details. The deal is expected to position Amneal as a fully integrated global biosimilar platform. Management sees more than $300 billion in projected global biologics loss-of-exclusivity over the next decade, which could support Amneal’s biosimilar expansion and diversification, creating long-term value. By 2030, Amneal expects to have more than 12 commercial biosimilars and over 20 additional products in its pipeline. The latest deal expands Amneal’s biosimilars long-term growth portfolio. Per management, the impending acquisition of Kashiv is expected to generate substantial financial synergies for Amneal, with projected benefits of $400-$500 million. Year to date, shares of Amneal have risen 1.8% compared with the industry’s increase of 1.9%. Image Source: Zacks Investment Research Preliminary adjusted earnings were 27 cents per share, up 29% year over year. Preliminary adjusted earnings beat the Zacks Consensus Estimate of 17 cents. Preliminary total revenues of $723 million in the first quarter of 2026 rose 4% year over year. The Zacks Consensus Estimate for revenues is pegged at $713 million. Affordable Medicines: First-quarter revenues were $423 million, up 2% year over year. Segment growth was driven by the strong performance of the complex portfolio, including Women’s Health and ADHD medicines. Specialty: First-quarter revenues of $133 million grew 23% year over year, with robust uptake of Crexont and steady Rytary and Unithroid growth. The quarter included initial sales from Brekiya following its recent launch. Meanwhile, AvKARE net revenues of $166 million declined 4% year over year as gr...
Investor releaseQuarter not tagged2026-04-22Amneal Pharmaceuticals (AMRX) Q1 Earnings and Revenues Surpass Estimates
Zacks
Amneal Pharmaceuticals (AMRX) Q1 Earnings and Revenues Surpass Estimates
Amneal Pharmaceuticals (AMRX) came out with quarterly earnings of $0.27 per share, beating the Zacks Consensus Estimate of $0.17 per share. This compares to earnings of $0.21 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +63.64%. A quarter ago, it was expected that this pharmaceutical company would post earnings of $0.18 per share when it actually produced earnings of $0.21, delivering a surprise of +16.67%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Amneal, which belongs to the Zacks Medical - Drugs industry, posted revenues of $723 million for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 1.86%. This compares to year-ago revenues of $695.42 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Amneal shares have added about 3.3% since the beginning of the year versus the S&P 500's gain of 3.2%. While Amneal has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Amneal was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) sto...
TranscriptFY2026 Q12026-04-22FY2026 Q1 earnings call transcript
Earnings source - 43 paragraphs
FY2026 Q1 earnings call transcript
Good morning, and welcome to today's Amneal Pharmaceuticals Investor Call. I will now turn the call over to Amneal's Head of Investor Relations, 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. 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. 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.
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 #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. 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. 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. 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. 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. 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. Let me turn it over to Chintu to share more about 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. Kashiv is a biologics platform built over 12 years with more than $900 million invested, 600-plus employees and 4 R&D and manufacturing sites. It brings proven capabilities, a differentiated portfolio and a global operational footprint in U.S. and India, which provides reliable supply chain and cost efficiencies. Turning to Slide 6. Kashiv adds deep biosimilar development expertise and scaled U.S. and India manufacturing, enabling multiple programs to run in parallel with speed and cost efficiency. The platform can support 3 to 5 biosimilars developments annually and offers end-to-end biologics capabilities from clone development and protein characterization through clinical and regulatory execution. 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. I will hand it over to Tasos to share more on the transaction.
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. 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. 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. 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. 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. 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. Let me now hand it back to 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. 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. Physician adoption is accelerating, patient access is expanding and the U.S. regulatory advancements are lowering development time and cost. Today, about half of U.S. 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 health care system. In 2024, biosimilars were estimated to have saved the U.S. health care 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. And today, there is no clear U.S. 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. I'll pass it back to Chintu to share more on the combined capabilities and portfolio.
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 #3 in U.S. 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. 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. 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 U.S. opportunity and more globally. First, we expect to have 6 commercial biosimilars by 2027, including biosimilars for Avastin and Denosumab and a biosimilar for XOLAIR, which is pending approval. Second, we expect 6 or more additional approvals from our advanced pipeline by 2030. 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 1 or 2 competitors expected and others are widely used products with large markets, creating a durable and scalable growth engine. 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. Let me now pass it back to 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. 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. 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 IV data, which showed CREXONT as having more than 3 hours good downtime versus RYTARY, reflecting the CREXONT's compelling clinical profile. 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. 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. 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. 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. 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. There are 2 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. Let me now hand it back over to 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. 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 U.S. prescriptions each year. 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 #1 affordable medicines company and a leading global provider of essential medicines because innovation only matters when it reaches the patients. With that, thank you, and we will open the line for questions.
[Operator Instructions] Your first question comes from the line of Matt Dellatorre with Goldman Sachs.
Congrats on the deal. I know this was a long time coming, so very exciting. Maybe 2 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. 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? And then I realize you're primarily focused on the U.S. 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 2 to 3 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?
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. 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 2 to 3 competitors. 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. Your second question on how do I think about U.S. 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. 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. 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. 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. 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 #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. 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 5 years than it had for the last 5 years. So tremendous growth opportunity in core business by itself. 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 2 hours, 3 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. 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. 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. 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. 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 3 to 5 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.
Your next question comes from the line of Les Sulewski with 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? 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?
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 2 sites, U.S., which, as you know, we are a U.S. champion. We always believe in U.S. manufacturing. So we keep expanding U.S. 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. 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.
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 U.S. and India perspective also. So if it's a cost sensitive product, we will have enough capacity in India and also in U.S. 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 U.S. specially, we are playing globally in this market. So we are pretty comfortable with the 20 products having 75,000 liters. 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 2, 3 years on the CapEx to get to the 75,000 liter.
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 points 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 6 years now, number one. Number two 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. 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. 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 5, 6 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 3 to 4 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.
Your next question comes from the line of David Amsellem with Piper Sandler.
So I have a few. First, can you just comment and elaborate on the insider ownership of Kashiv? That's number one. 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? And then the last question is how much of your revenue base by 2030 do you expect will be from biosims?
David, I'll take question #2 and #3. If you can just -- can you just repeat question number one for a second, if you don't mind?
Yes, the insider ownership of Kashiv.
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 #1, hopefully. Number two 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 one. Number two, 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. 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. 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. 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. 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. 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.
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...
So...
Footprint now, yes.
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.
Your next question comes from the line of Chris Schott with JPMorgan.
Just 2 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? 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?
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. 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. 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 5 to 7 years. It requires a lot of manufacturing infrastructure, a lot of R&D infrastructure, number of years, even with FDA's Phase III gone, still will be 5-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 5, 7 years. 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 U.S.-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 U.S. in mind. 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 2 to 3 competitors. So that's how we see the competitive landscape, maybe 8 to 10 players. There are 118 molecules to go after. 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 3 to 5 per year. Chintu, do you want to add anything?
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 5, 7 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. And that experience, I think, gives us the confidence of this 3 to 5 biosimilar. So competition, as Chirag stated, would be these 4, 5 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.
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.
And this is also a 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.
Your next question comes from the line of Glen Santangelo with Barclays.
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. 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.
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. 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. 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. 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.
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 one. 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. Point number two, 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 two. And number three, 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. 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.
Your next question comes from the line of Ash Verma with UBS.
This is [indiscernible] 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 time line in 3Q? And what will be the gating items for the launch? 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.
Thank you, [indiscernible] 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.
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. 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.
There are no further questions at this time. I will now turn the call back to Chirag Patel for closing remarks.
Well, thank you, everyone, and have a great day.
This concludes today's call. Thank you for attending. You may now disconnect.
Investor releaseQuarter not tagged2026-04-20Amneal Announces Additional Positive Interim Phase 4 ELEVATE-PD Results with CREXONT® for Parkinson’s Disease, Including Over 3 More Hours of Daily “Good On” Time When Switching from RYTARY®
GlobeNewswire
Amneal Announces Additional Positive Interim Phase 4 ELEVATE-PD Results with CREXONT® for Parkinson’s Disease, Including Over 3 More Hours of Daily “Good On” Time When Switching from RYTARY®
Phase 4 ELEVATE-PD interim data (n=111) demonstrated clinically meaningful, consistent benefits of CREXONT across all prior treatment groups Demonstrated substantial increases in daily “Good On” time, reductions in “Off” time, and meaningful improvements in motor function after switching to CREXONT® Patients switching to CREXONT® from RYTARY® gained 3.07 hours of additional daily “Good On” time and nearly doubled the duration of continuous “Good On” intervals, enabling longer, uninterrupted periods of effective symptom control BRIDGEWATER, N.J., April 20, 2026 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), today announced new positive interim results from its ongoing Phase 4 ELEVATE-PD study, presented at the 2026 American Academy of Neurology (AAN). The first 111 patients evaluated after six weeks of treatment demonstrated substantial clinical benefit after switching to CREXONT® (carbidopa and levodopa) extended-release capsules, regardless of whether patients switched from immediate-release carbidopa/levodopa (IR CD/LD), IR CD/LD plus a COMT inhibitor, or RYTARY® (carbidopa and levodopa) extended-release capsules. These interim findings build on the established efficacy and safety profile of CREXONT demonstrated in the Phase 3 RISE-PD trial and reflected in the FDA-approved prescribing information. After patients switched from prior therapies, treatment with CREXONT delivered meaningful increases in “Good On” time, reductions in “Off” time, and improved motor symptom control. Patients switching from RYTARY achieved consistent gains in continuous “Good On” intervals – the length of uninterrupted time patients spend feeling their best. The most common adverse events (≥3%) in the study were dizziness (9.0%), nausea (7.2%), falls (7.2%), dyskinesia (4.5%), hallucination (3.6%), and headache (3.6%). “In the absence of a cure for Parkinson’s, our goal as clinicians is to help patients better manage their symptoms and preserve quality of life for as long as possible,” said Dr. Robert Hauser, MD, a study investigator and Professor of Neurology at the Parkinson’s Disease and Movement Disorders Center, University of South Florida. “These encouraging interim results underscore the real-world impact CREXONT can have in giving patients more ‘Good On’ time with fewer dosing interruptions throughout their day-to-day.” “When w...
Investor releaseQuarter not tagged2026-04-08Amneal to Report First Quarter 2026 Results on May 1, 2026
GlobeNewswire
Amneal to Report First Quarter 2026 Results on May 1, 2026
BRIDGEWATER, N.J., April 07, 2026 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”), today announced that the Company will release its first quarter 2026 financial results on Friday, May 1, 2026, prior to market open. The Company will host an audio webcast at 8:30 a.m. ET. The financial results and live webcast will be accessible through the Investor Relations section of the Company's website at https://investors.amneal.com. Individuals may register for the webcast by clicking the link here. To access the call through a conference line, dial 1 (833) 461-5787 (in the U.S.) or for a list of toll-free international numbers, visit this here. The access code for the call is 458312872. A replay of the conference call will be posted shortly after the call. About Amneal Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, New Jersey, is a diversified, global biopharmaceutical leader focused on expanding access to affordable and innovative medicines. Founded in 2002 by brothers and co-CEOs Chirag and Chintu Patel, Amneal was built on the belief that innovation only matters if it’s accessible. Today, Amneal has a diverse and growing portfolio of approximately 300 complex, specialty and biosimilar medicines, delivering over 160 million prescriptions each year, primarily in the United States. Our Affordable Medicines segment spans retail, injectable, and biosimilar products. Our Specialty segment provides branded treatments in neurology, including Parkinson’s disease and migraine, and endocrinology. Our AvKARE segment distributes pharmaceuticals and medical products to U.S. federal, retail, and institutional customers. For more information, visit www.amneal.com and follow us on LinkedIn. Investor Contact Anthony DiMeo VP, Investor Relations [email protected]
Investor releaseQuarter not tagged2026-03-11Q4 Earnings Roundup: Amneal (NASDAQ:AMRX) And The Rest Of The Generic Pharmaceuticals Segment
StockStory
Q4 Earnings Roundup: Amneal (NASDAQ:AMRX) And The Rest Of The Generic Pharmaceuticals Segment
Wrapping up Q4 earnings, we look at the numbers and key takeaways for the generic pharmaceuticals stocks, including Amneal (NASDAQ:AMRX) and its peers. The generic pharmaceutical industry operates on a volume-driven, low-cost business model, producing bioequivalent versions of branded drugs once their patents expire. These companies benefit from consistent demand for affordable medications, as they are critical to reducing healthcare costs. Generics typically face lower R&D expenses and shorter regulatory approval timelines compared to branded drug makers, enabling cost efficiencies. However, the industry is highly competitive, with intense pricing pressures, thin margins, and frequent legal challenges from branded pharmaceutical companies over patent disputes. Looking ahead, the industry is supported by tailwinds such as the role of AI in streamlining drug development (reverse engineering complex formulations) and manufacturing efficiency (optimize processes and remove inefficiencies). Governments and insurers' focus on reducing drug costs can also boost generics' adoption. However, headwinds include escalating pricing pressure from large buyers like pharmacy chains and healthcare distributors as well as evolving regulatory hurdles. The 4 generic pharmaceuticals stocks we track reported a mixed Q4. As a group, revenues beat analysts’ consensus estimates by 2.4%. Amidst this news, share prices of the companies have had a rough stretch. On average, they are down 12.5% since the latest earnings results. Founded in 2002 and growing into one of America's largest generic drug producers, Amneal Pharmaceuticals (NASDAQ:AMRX) develops, manufactures, and distributes generic medicines, specialty branded drugs, biosimilars, and injectable products for the U.S. healthcare market. Amneal reported revenues of $814.3 million, up 11.5% year on year. This print exceeded analysts’ expectations by 0.9%. Despite the top-line beat, it was still a mixed quarter for the company with an impressive beat of analysts’ full-year EPS guidance estimates but full-year revenue guidance missing analysts’ expectations significantly. Unsurprisingly, the stock is down 7.2% since reporting and currently trades at $13.45. Is now the time to buy Amneal? Access our full analysis of the earnings results here, it’s free. With a diverse portfolio of 116 pharmaceutical products and a growing rare dise...
Investor releaseQuarter not tagged2026-02-28Amneal Pharmaceuticals Inc (AMRX) Q4 2025 Earnings Call Highlights: Strong Financial Growth and ...
GuruFocus.com
Amneal Pharmaceuticals Inc (AMRX) Q4 2025 Earnings Call Highlights: Strong Financial Growth and ...
This article first appeared on GuruFocus. Revenue Growth 2025: 8% increase to $3 billion. Adjusted EBITDA Growth 2025: 10% increase to $688 million. Adjusted EPS Growth 2025: 43% increase to $0.83. Q4 Revenue: 11% increase to $814 million. Q4 Adjusted EBITDA: 13% increase to $175 million. Q4 Adjusted EPS: 75% increase to $0.21. Operating Cash Flow 2025: $340 million. Net Leverage 2025: Reduced to 3.5 times. 2026 Revenue Guidance: $3.05 billion to $3.15 billion, 1% to 4% growth. 2026 Adjusted EBITDA Guidance: $720 million to $760 million, 5% to 10% growth. 2026 Adjusted EPS Guidance: $0.93 to $1.03, 12% to 24% growth. 2026 Operating Cash Flow Guidance: $325 million to $375 million. 2026 CapEx: Approximately $110 million. Adjusted Gross Margin 2025: Increased by 50 basis points to approximately 43%. Debt Refinancing: Extended maturities to 2032, reduced interest costs. Warning! GuruFocus has detected 6 Warning Signs with AMRX. Is AMRX fairly valued? Test your thesis with our free DCF calculator. Release Date: February 27, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Amneal Pharmaceuticals Inc (NASDAQ:AMRX) reported an 8% revenue growth, a 10% increase in adjusted EBITDA, and a 43% rise in adjusted EPS for 2025. The company achieved significant portfolio expansion with approvals and launches in complex generics and injectables, which are expected to drive multiyear value. Amneal Pharmaceuticals Inc (NASDAQ:AMRX) is building a strong position in the biosimilars market, with six biosimilars expected in the US market by 2027. The Specialty segment showed strong performance, with CREXONT achieving a 3% market share and expected peak US sales of $300 million to $500 million. The company successfully reduced net leverage to 3.5 times and extended debt maturities to 2032, substantially reducing interest costs. The Affordable Medicines segment was essentially flat in Q4 2025, reflecting the timing of key products and new launches. The Specialty segment is expected to be flat in 2026 due to expected generic erosion of RYTARY, despite the growth of CREXONT. Health Care segment revenues are expected to decline in 2026 due to a pivot away from low-margin distribution business and increased competition for generic Entresto. The company faces challenges in the supply chain for Iohexol, which may impact the ramp-up...

