Amneal Pharmaceuticals Conference: “Amneal 2.0” Targets 2026 Growth in Biosimilars, CREXONT and AvKARE Shift

Key Points

• Amneal 2.0 centers on biosimilars as the highest-growth driver with plans for M&A to vertically integrate U.S. development, manufacturing and commercialization; denosumab is expected in H2 and XOLAIR to contribute in 2027, with management targeting ~100 basis points of margin improvement in 2026.
• Amneal is shifting AvKARE away from a low‑margin "pure distribution" business (about $350M in revenue) toward the more profitable VA/DoD channel, focusing on value‑added generics, injectables and future biosimilar/branded offerings.
• CREXONT is the specialty growth engine—reaching roughly 25,000 patients in its first year and converting ~80% of extended‑release patients with $300–$500M peak sales guidance—while management assumes generic competition for RYTARY from April 1 and reports stronger‑than‑expected early uptake for Brekiya.

Amneal Pharmaceuticals NASDAQ: AMRX used a recent investor presentation to highlight momentum coming out of fiscal 2025 and outline priorities for 2026 and beyond, emphasizing growth drivers across its Affordable Medicines business, specialty portfolio, and its AvKARE distribution unit.

Management recaps 2025 progress and “Amneal 2.0” strategy

Co-CEO and President Chirag Patel said the company’s recent performance reflects a multi-year strategy the team refers to as “Amneal 2.0,” which he traced back to a strategic reset that began after he and his brother returned to leadership in 2019. Patel said the company focused first on strengthening its base business, launching new products, and investing in more complex research and development.

He also pointed to efforts to diversify the business, including the 2020 acquisition of AvKARE, a distributor with a meaningful presence in U.S. government channels. Patel said Amneal has also continued investing in specialty products, citing milestones such as the approval and launch of CREXONT, the launch of Brekiya, and biosimilar activity.

Patel characterized 2025 as “amazing” and said the company met and raised guidance. He also noted Amneal received BioSpace’s “Best Company to Work For” award, which he said had historically gone to large pharmaceutical companies.

AvKARE shift: De-emphasizing low-margin distribution

Patel said Amneal is changing how it approaches AvKARE by de-emphasizing a lower-margin distribution business that competes with traditional wholesalers. He described AvKARE’s VA/DoD channel as the most profitable part of the operation and said that portion is where the company is growing, citing “value-added generics and injectables” and future inclusion of biosimilars and branded products.

By contrast, Patel described the de-emphasized portion as a “pure distribution” business generating roughly $350 million in revenue with comparatively limited profitability. He said the company does not intend to invest behind that distribution activity.

Affordable Medicines: Retail generics breadth, complex injectables, and biosimilars

Patel framed the Affordable Medicines segment as encompassing three areas: retail generics (small molecules), injectables, and biosimilars. He said all three are “essential medicines,” noting that generics fill the majority of prescriptions.

• Retail generics: Patel said Amneal is a top-three supplier in the U.S. retail channel and expects to move to number two. He cited ongoing growth driven by launches in ophthalmics and transdermal products and said the company is working to increase supply of DOTTI amid increased demand. He also highlighted an inhalation portfolio that includes approved products PROAIR and QVAR, and said the company offers a broad retail portfolio of about 260 products.
• Injectables: Patel described the company’s focus as “very complex injectables,” referencing long-acting depot products and iohexol. He also said lanreotide could be approved “very soon” and noted work on ready-to-use bag products that were previously compounded and are now FDA-approved.
• Biosimilars: Patel said biosimilars are expected to be the highest-growth component, while also indicating Amneal may pursue M&A to support vertical integration across development, manufacturing, and commercialization in the U.S., with partners handling commercialization outside the U.S.

On the biosimilar outlook, Patel said recent results were influenced by price pressure on certain products and named Avastin, Neupogen, and Neulasta as examples. He said denosumab is expected to launch in the second half of the year, with XOLAIR expected to contribute more meaningfully in 2027. Patel added that additional launches in later years could follow if the company completes a vertical integration transaction, referencing a broader biosimilar opportunity set and a pipeline that could expand through partnerships.

Patel also discussed a margin outlook, stating the company saw margins increase in 2025 and expects another 100 basis points of margin improvement in 2026, linking longer-term margin progress to owning manufacturing, distribution, and R&D capabilities for biosimilars in the U.S.

Specialty: Planning for RYTARY LOE while scaling CREXONT and Brekiya

In specialty, Patel said the company has incorporated into guidance the assumption of generic competition for RYTARY beginning April 1, while noting that any delay would be beneficial.

He positioned CREXONT as the key growth driver, calling its first-year launch performance “superb” and saying it has outperformed expectations. Patel said the product has reached roughly 25,000 patients in about a year and claimed it converted 80% of extended-release patients. He contrasted that with RYTARY, which he said took six to seven years to reach 25,000 patients. Patel attributed CREXONT’s uptake to patient benefits including fewer daily doses and improved “on time,” and said the company focused on reducing prescription rejection rates based on lessons learned from RYTARY.

Patel reiterated current guidance for CREXONT peak sales of $300 million to $500 million and discussed ongoing and planned studies, including work in treatment-naïve patients and phase IV data that he said showed 3.13 hours of additional “good on time.” He also said the product has been out-licensed in Europe and other regions, with Amneal planning to launch the product directly in India.

Patel also discussed Brekiya, describing it as an auto-injector formulation intended to enable at-home use for patients suffering from cluster headaches and severe migraine. He said early uptake has been higher than expected, though he did not indicate a change to previously discussed peak sales expectations during the discussion.

Capital allocation and priorities: R&D investment and biosimilar integration

On capital allocation, Patel said the company plans to continue investing in R&D—citing an annual range of roughly $180 million to $200 million—as well as ongoing capital expenditures. He said a top priority for the year is biosimilar vertical integration and suggested the company hopes to announce related plans “shortly.”

In closing remarks, Patel said the company remains focused on executing against its portfolio and sees a significant opportunity to build a top-five position in U.S. biosimilars. He also noted the company has additional specialty R&D candidates that could be announced toward the end of the year or early next year, and said international markets—especially India and partnerships in Europe and other regions—could become more meaningful over a three- to five-year timeframe.

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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