Amneal Pharmaceuticals Q2 Earnings Call Highlights

Key Points

• Amneal reported strong Q2 results, with revenue up 10% to $796 million, adjusted EBITDA up 12% to $206 million and adjusted EPS up 20% to $0.30. Growth in affordable medicines and specialty products offset a decline in AvKARE distribution.
• The company raised its 2026 outlook to $3.1 billion–$3.2 billion in revenue, $750 million–$780 million in adjusted EBITDA and $0.96–$1.06 in adjusted EPS, despite an estimated $20 million flood-related impact in India.
• Amneal is advancing major growth initiatives, including the pending Kashiv acquisition, expanded biosimilar capabilities and manufacturing investments in patches and injectables. Management expects more than 20 biosimilar programs and six commercialized biosimilars by next year.

Amneal Pharmaceuticals NASDAQ: AMRX reported second-quarter 2026 revenue of $796 million, up 10% from a year earlier, as growth in its affordable medicines and specialty businesses offset a decline at its AvKARE distribution unit. The company raised its full-year revenue, adjusted EBITDA and adjusted earnings-per-share outlook, citing broad-based demand, new product launches and favorable product mix.

Adjusted EBITDA rose 12% to $206 million, while adjusted diluted earnings per share increased 20% to $0.30. Adjusted gross margin expanded 60 basis points year over year to 46.2%, which Chief Financial Officer Tasos Konidaris attributed to mix improvements and operating efficiencies.

“The second quarter played out as expected, with revenue growth accelerating and broad-based momentum building across our business,” Konidaris said during the company’s earnings call.

Segment Growth Led by Affordable Medicines and Specialty

Revenue in Amneal’s affordable medicines segment increased 13% to $490 million. The company said the result reflected demand across its complex product portfolio, including women’s health products, injectables and naloxone. New launches contributed $45 million to second-quarter revenue growth, including recently launched ophthalmology and urology products.

Specialty revenue increased 17% to $149 million, driven by CREXONT, Unithroid and Brekiya. Co-CEO and President Chirag Patel said CREXONT, a Parkinson’s therapy, continues to gain traction, with approximately 80% of prescriptions coming from general neurologists. He said the company aims to position the therapy as a first-line treatment.

Amneal also discussed Phase IV data for CREXONT. Co-CEO Chintu Patel said an open-label study showed patients converting to CREXONT had three or more hours of “good on time” per day compared with RYTARY and other carbidopa/levodopa therapies, alongside improvement in symptom control. The company plans to begin another Phase IV study in the fourth quarter involving recently diagnosed, treatment-naive Parkinson’s disease patients.

AvKARE revenue fell 4% to $157 million, as government-channel growth was offset by lower-margin distribution business, according to Konidaris. The company said it remains focused on its government and institutional channel opportunities.

Guidance Raised Despite Flood-Related Impact

Amneal raised its 2026 revenue forecast by $50 million to a range of $3.1 billion to $3.2 billion. It now expects adjusted EBITDA of $750 million to $780 million, an increase of $10 million from its previous outlook, and adjusted EPS of $0.96 to $1.06, up one cent at both ends of the prior range.

The guidance includes an estimated $20 million negative impact from severe rainfall and flooding in Gujarat, India, which affected one of Amneal’s facilities. Chintu Patel said all employees were safe and accounted for, and the company expects a limited impact on a select number of products. Operations at the affected site are expected to resume within the next few weeks.

Amneal increased its capital-expenditure expectations to between $110 million and $150 million, citing opportunities in women’s health products and U.S. injectable expansion. It maintained its operating cash flow guidance.

The company also said it repriced its $2.4 billion Term Loan B due in 2032, lowering its interest expense by 50 basis points. Konidaris said the refinancing is expected to produce approximately $12 million in annual interest savings.

Kashiv Acquisition and Biosimilar Pipeline

Management continued to emphasize the pending acquisition of Kashiv, which it expects to close in the coming weeks following a shareholder vote and satisfaction of closing conditions. The deal is intended to add biologics development and manufacturing capabilities to Amneal’s commercial platform.

Chintu Patel said Kashiv’s drug-substance capacity is expected to expand from approximately 26,000 liters by the end of 2026 to about 75,000 liters by 2028. The combined company expects to have a pipeline of more than 20 biosimilar programs and cited opportunities involving Xolair, Orencia, Cimzia and Stelara.

Chirag Patel said Amneal currently markets ALYMSYS, Releuko and Fylnetra and expects to launch biosimilars for Prolia and Xgeva. He said a Xolair biosimilar could launch very late this year or potentially in early 2027, though no Xolair contribution is included in 2026 guidance. The company expects to commercialize six biosimilars by next year.

Konidaris said the Kashiv transaction is expected to generate $400 million to $500 million in financial benefits through tax and local incentives and the elimination of milestone and profit-sharing obligations. Amneal expects net leverage to fall below three times by 2028.

Complex Generics, Capacity Expansion and Product Launches

Management said it is expanding manufacturing capacity for estrogen transdermal patches following increased demand after revised FDA guidance late last year. Chirag Patel said the company plans to triple patch capacity by next year. Amneal is also expanding capacity for lidocaine patches and U.S. sterile injectables.

The company expects a potential approval and launch of lanreotide during the third quarter, with a conservative revenue contribution included in its forecast. Chirag Patel described lanreotide as a complex drug-device combination with multiple barriers to entry.

Amneal also cited recent approvals for romidepsin, additional iohexol strengths and ready-to-use sodium bicarbonate. The company expects additional iohexol approvals by year-end and said the product could represent a $50 million-plus opportunity over time, with more substantial revenue contribution anticipated beginning in 2027.

Looking ahead, Amneal plans to file 12 to 15 high-value complex abbreviated new drug applications this year, including two metered-dose inhalation products. The company also said its Brookhaven, New York, facility was selected as one of seven companies in the FDA’s PreCheck pilot program, which is designed to support earlier engagement on facility readiness and strengthen domestic pharmaceutical manufacturing capacity.

About Amneal Pharmaceuticals (NASDAQ:AMRX)

Amneal Pharmaceuticals, Inc is a publicly traded integrated healthcare company specializing in the development, manufacturing and distribution of generic and specialty pharmaceutical products. The company’s portfolio includes oral solids, injectables, transdermals and biosimilars, serving a broad range of therapeutic areas such as cardiovascular, neuroscience, oncology and women’s health. Alongside its generic offerings, Amneal has built a branded portfolio through strategic acquisitions and internal development, positioning itself across both high-volume generics and higher-value specialty treatments.

Since its founding in 2002 by brothers Chirag and Chintu Modgil, Amneal has pursued growth through organic investment in research and development as well as targeted M&A.

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