What Amneal Pharmaceuticals (AMRX) Said on Its Q3 Earnings Call

Key Points

• Amneal reported strong Q3 results, with revenue up 10% year over year to $863 million, adjusted EBITDA up 30% to $207 million and adjusted EPS up 53% to $0.26. Growth in affordable medicines and specialty products offset the expected decline at AvKARE.
• Management raised its 2026 revenue, EBITDA and EPS outlook, citing demand for complex generics, specialty brands and biosimilars. Operating cash flow guidance was reduced because of higher inventory investment and collections shifting into early 2027.
• The Kashiv acquisition expands Amneal’s integrated biosimilar platform and is expected to generate $400 million–$500 million in financial benefits. Management also highlighted growth opportunities from lanreotide, iohexol, CREXONT, BREKIYA and future biosimilar launches, including XOLAIR.

Amneal Pharmaceuticals NASDAQ: AMRX reported third-quarter 2026 revenue of $863 million, up 10% from a year earlier, as growth in affordable medicines and specialty products more than offset an expected decline at its AvKARE business. Adjusted EBITDA rose 30% to $207 million, while adjusted earnings per share increased 53% to $0.26.

Management raised its full-year outlook, citing continued demand for complex generics, specialty brands and biosimilars. The company also highlighted the August closing of its Kashiv acquisition, which it said gives Amneal in-house biosimilar development, manufacturing and commercialization capabilities.

Raised 2026 Outlook

CFO Tasos Konidaris said Amneal increased its 2026 revenue outlook by $50 million at the midpoint to a range of $3.15 billion to $3.25 billion. The company raised its adjusted EBITDA outlook by $43 million at the midpoint to $800 million to $815 million and lifted adjusted EPS guidance to $1.04 to $1.08, up $0.05 at the midpoint.

Operating cash flow guidance was lowered by $25 million at the midpoint to $325 million to $375 million. Konidaris said the revision reflected the company’s decision to increase finished-goods inventory to meet demand, as well as the timing of collections that are expected to shift into the first quarter of 2027.

For the first nine months of 2026, Amneal said revenue increased 8%, adjusted EBITDA rose 20%, and adjusted EPS grew 34%.

• Affordable medicines revenue rose 19% to $547 million.
• Specialty revenue increased 20% to $150 million.
• AvKARE revenue declined 17% to $165 million, reflecting a nonrecurring product introduction in the prior-year quarter.
• Adjusted gross margin increased 50 basis points year over year to 43.2%.

Affordable medicines growth was driven by women’s health transdermal patches, new product launches that contributed $54 million during the quarter, and favorable timing of a large biosimilar customer order that added about $40 million, Konidaris said.

Lanreotide Launch and Complex Generics Pipeline

Amneal received FDA approval for lanreotide in September and launched the product late in the month. Konidaris said lanreotide generated about $7 million of revenue in the third quarter, with a meaningfully larger contribution expected in the fourth quarter as the company addresses market demand.

The company is targeting roughly 30% to 40% market share for lanreotide over time, he said. Co-CEO Chintu Patel said Amneal plans to file post-approval supplements for the 60 mg and 90 mg strengths during the current quarter, with a launch expected in the second half of next year. He noted that approximately 90% of sales are in the currently approved 120 mg strength.

Chintu Patel said Amneal has now filed all iohexol stock-keeping units and expects the imaging agent to be a key growth driver in 2027. The company said it is the only generic supplier currently and has expanded capacity and supply-chain capabilities for the product.

Management also cited recent approvals for romidepsin ready-to-use, sodium bicarbonate IV bags and additional strengths and presentations of iohexol. The company is building new U.S. sterile injectable capabilities targeted for 2028 and is advancing long-acting injectable, inhalation and 505(b)(2) programs.

Amneal received its first two inhalation approvals last year for PROAIR and QVAR and is targeting five additional metered-dose inhaler and soft-mist approvals over the next three years, according to Chintu Patel.

Kashiv Integration Expands Biosimilar Platform

The company said its acquisition of Kashiv has created an integrated biosimilar platform spanning cell-line and clone development, clinical work, regulatory functions, biologics manufacturing and commercialization. Amneal is expanding biosimilar manufacturing in New Jersey and India and is targeting early-to-market global opportunities where it can be first or second to launch.

Konidaris said the Kashiv transaction is expected to provide $400 million to $500 million in financial benefits through the elimination of profit-sharing obligations and tax incentives. He pointed to lanreotide, which originated at Kashiv, as an example of a product for which Amneal now retains all profits. The company also secured $60 million in tax credits from the New Jersey Economic Development Authority, largely related to manufacturing expansion supporting the Kashiv deal and biosimilar roadmap.

During the question-and-answer session, Chirag Patel said Amneal expects to launch its XOLAIR biosimilar in the second half of next year, toward the later part of the year, subject to discussions around a patent settlement. He said the company expects to be the second entrant after Celltrion, while Teva has also filed a product.

Management said it expects the majority of its projected revenue growth through 2030 to come from affordable medicines, particularly biosimilars. Konidaris said biosimilars carry higher gross margins than much of Amneal’s existing business, while full ownership of Kashiv’s economics should also support profitability.

Specialty Brands Gain Traction

Specialty revenue growth was led by CREXONT for Parkinson’s disease, BREKIYA autoinjector for migraine and cluster headache, and UNITHROID. Chirag Patel said CREXONT continues to gain share, supported by patient experience and clinical evidence that he said showed more than three additional hours of “good on” time per day versus other therapies.

Joe Renda, Amneal’s senior vice president and chief commercial officer of specialty, said the company is adding about 400 CREXONT prescribers each month and continues to see substantial growth in total prescriptions. He said the company is confident CREXONT can reach the middle or potentially higher end of its longer-term expectations.

Renda said BREKIYA autoinjector has exceeded the company’s expectations this year, with performance tracking at about twice its original expectation. Amneal expects 2027 performance could also approach double this year’s level, he said, citing expanded access to headache prescribers and increased cartons used per patient.

Chirag Patel said BREKIYA is seeing conversion rates of roughly 50% to 60% and has not yet encountered significant payer restrictions.

Manufacturing Investments and Leverage Targets

Amneal said a facility in India that experienced flooding in late July has fully resumed operations. The company is also expanding capacity for women’s health transdermal patches, complex injectables, biosimilars and GLP-1 products.

Its GLP-1 collaboration with Pfizer remains on track, with construction of dedicated drug-substance and drug-product facilities expected to be completed in late 2028 to 2029, according to Chintu Patel. He said the companies are discussing the future structure of co-marketing efforts across 18 markets where Amneal has exclusive access.

Net leverage stood at 3.0 times adjusted EBITDA at the end of the third quarter following the Kashiv acquisition. Amneal expects leverage to finish 2026 at 3.6 times adjusted EBITDA, in line with year-end 2025, and said it remains confident it can reduce leverage below 3 times adjusted EBITDA by 2028.

About Amneal Pharmaceuticals (NASDAQ:AMRX)

Amneal Pharmaceuticals, Inc is a specialty pharmaceutical company that develops, manufactures and commercializes a broad portfolio of generic and specialty medicines. Its products include oral, injectable and inhaled medications, as well as complex dosage forms and other products designed to address areas where manufacturing or formulation requirements can be more challenging.

The company's generics business offers medicines across a range of therapeutic categories, including central nervous system, cardiovascular, gastrointestinal, anti-infective and other treatments.

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