Amneal Raises 2026 Earnings Outlook After Q3 EBITDA Jumps 30%

Amneal Pharmaceuticals (NASDAQ: AMRX) raised its full-year 2026 revenue, adjusted EBITDA and adjusted earnings guidance after third-quarter growth in its Specialty and Affordable Medicines businesses lifted revenue by 10% and adjusted EBITDA by nearly 30%. The company also lowered its operating cash flow outlook, reflecting higher inventory, collection timing and costs associated with its Kashiv acquisition.

For the quarter ended Sept. 30, revenue rose to $863 million from $785 million a year earlier. Adjusted EBITDA increased 29.7% to $207 million, while adjusted diluted earnings per share climbed 52.9% to $0.26 from $0.17.

Adjusted gross margin expanded 50 basis points to 43.2%, helped by a more favorable product mix. Adjusted EBITDA margin widened 370 basis points to 24.0%, reflecting higher revenue, improved gross margin and operating expense leverage. Adjusted research and development expense declined 11.6% to $56 million, while adjusted selling, general and administrative expense was unchanged at $127 million.

Operating cash flow fell 17% to $98 million because of the timing of collections and inventory investments in key growth areas, the company said.

Specialty and complex products drive growth

Specialty revenue advanced 20% to $150 million, led by CREXONT, the BREKIYA autoinjector and UNITHROID. The segment’s adjusted gross margin rose 190 basis points to 81.8% on favorable product mix.

CREXONT revenue increased 75% to $35 million in the quarter and reached $85 million for the first nine months, up 112%. Amneal expects the Parkinson’s disease treatment to generate $300 million to $500 million in U.S. peak sales. RYTARY revenue declined 10% to $40 million, while UNITHROID grew 15% to $43 million.

BREKIYA generated $6.2 million in third-quarter revenue and $17.9 million since its fourth-quarter 2025 launch. Amneal said initial physician and patient uptake was ahead of its expectations and projected U.S. peak sales of $50 million to $100 million.

Affordable Medicines revenue increased 19% to $547 million, supported by complex products, including Women’s Health transdermal patches and biosimilars, as well as launches such as lanreotide. Adjusted gross margin for the segment declined 240 basis points to 39.3%, reflecting product mix, flood effects and higher plant spending tied to investments in growth areas.

The business has more than 280 commercial products and is shifting toward complex dosage forms. Amneal expects 20 to 30 new launches annually and said its 2027-to-2029 pipeline contains about 60 potential launches, more than 75% of which are expected to be differentiated opportunities such as first-to-market, 505(b)(2) or other high-value products.

The biosimilars portfolio includes three commercial products, two approved denosumab biosimilars and an omalizumab biosimilar under review. The company expects to have at least 12 commercial biosimilars by 2030. It is also expanding injectables capacity and expects more than 10 injectable launches annually, focusing on complex products such as peptides, long-acting injectables, drug-device combinations and large-volume bags.

AvKARE revenue fell 17% to $165 million, with the comparison affected by a large product launch in 2025. Its adjusted gross margin was unchanged at 21.3%. For the first nine months, AvKARE revenue declined 8.6% to $488 million, while gross margin improved 110 basis points to 20.6%. Amneal expects full-year segment revenue of $625 million to $700 million and said AvKARE’s revenue growth is expected to resume in 2027 and beyond.

Full-year earnings outlook increases, cash flow forecast falls

Amneal now expects 2026 revenue of $3.15 billion to $3.25 billion, representing growth of 4% to 8%. Its previous range was $3.1 billion to $3.2 billion.

The adjusted EBITDA forecast increased to $800 million to $815 million from $750 million to $780 million, implying annual growth of 16% to 18%. Adjusted diluted EPS is expected to be $1.04 to $1.08, compared with the prior range of $0.96 to $1.06 and 2025 adjusted EPS of $0.83. The EPS outlook assumes approximately 340 million weighted-average diluted shares in 2026.

In contrast, projected operating cash flow was reduced to $325 million to $375 million from $350 million to $400 million. Excluding discrete items, the company expects $350 million to $400 million, down from its previous forecast of $375 million to $425 million. Those items include about $36 million of opioid settlement costs and approximately $40 million of Kashiv acquisition and integration costs. Planned capital expenditures remain about $150 million.

For the first nine months of 2026, revenue rose 8% to $2.38 billion and adjusted EBITDA increased 19.9% to $615 million. Adjusted diluted EPS grew 33.9% to $0.83. Operating cash flow, however, dropped to $50 million from $210 million because of higher inventory and collection timing.

Net debt increased to $3.07 billion at Sept. 30 from $2.66 billion at the end of June, primarily reflecting the Kashiv acquisition. Net leverage rose to 3.9 times from 3.6 times. Management expects leverage of about 3.6 times in the fourth quarter and below 3 times by 2028. Amneal’s blended borrowing cost is approximately 6%, with about half of its debt at fixed rates.

The outlook depends on prescription and pricing trends, launch timing, restructuring benefits and execution of the company’s longer-term strategy. Identified risks include integration of Kashiv, pharmaceutical competition and pricing pressure, supply-chain disruptions, tariffs, regulatory changes, product development and commercialization challenges, customer concentration, cybersecurity incidents and Amneal’s substantial debt burden. The company is also investing in two GLP-1-focused manufacturing sites that it expects to become operational by 2028, leaving the timing and returns from those projects subject to development, construction and commercialization execution.