Amneal Pharmaceuticals Bets on Biosimilars, Patches to Power Next Growth Phase

Key Points

• Amneal Pharmaceuticals says it is entering a stronger growth phase, helped by unexpectedly solid performance in its generics business and rising demand for hormonal and pain patches. The company is rapidly expanding capacity, especially for estrogen patches, with more supply expected to begin in August.
• Biosimilars are becoming a major growth pillar after the Kashiv BioSciences acquisition, with Amneal targeting a top-three U.S. position and about $1.2 billion in biosimilar revenue by 2030. The company has a pipeline of 20 biosimilars and expects lower development costs and faster timelines as the market shifts toward private-label distribution.
• Amneal’s specialty and partnership pipeline is also expanding, with CREXONT gaining traction, Brekiya’s market opportunity now seen as larger, and a Pfizer obesity-related partnership moving ahead. Management said the Pfizer deal likely won’t materially affect guidance until around 2030, while the company aims to keep leverage below 3x over time.

Amneal Pharmaceuticals NASDAQ: AMRX Co-Founder, President and Co-Chief Executive Officer Chirag Patel said the company is entering a stronger growth phase, driven by momentum in its existing generics portfolio, a newly expanded biosimilars platform and specialty product launches.

Speaking at a Goldman Sachs healthcare event with Goldman Sachs biopharma analyst Matt Dellatorre, Patel said Amneal’s in-line products, which he said typically decline 4% to 5%, could grow 10% to 15% this year. He attributed that shift in part to demand for hormonal patches and pain patches, which the company manufactures in Yardley, New Jersey.

Patel said Amneal is working to expand capacity quickly, particularly for estrogen patches. He said demand has accelerated following changes in warnings and evolving views on the therapy, adding that use among women ages 45 to 65 could rise significantly from prior levels. “We’re tripling our capacity, maybe quadrupling it in months,” Patel said, adding that more supply is expected beginning in August.

Biosimilars Become a Larger Growth Pillar

Patel said Amneal’s acquisition of Kashiv BioSciences gives the company a vertically integrated biosimilars business, including research and manufacturing capabilities. He described biosimilars as “an entire new pillar of growth” alongside Amneal’s small-molecule business.

According to Patel, the company has a pipeline of 20 biosimilars and manufacturing capabilities across multiple sites, including a plant in Chicago focused on E. coli-based products, a site in New Jersey focused on monoclonal antibodies and additional operations in India. He said the company is applying the same operating approach it used in its broader generics business to Kashiv’s biosimilar pipeline.

Patel said Amneal is aiming to become a top-three biosimilars player in the United States, while using a partner model globally. He said significant revenue could also come from international markets.

Dellatorre noted that Amneal has given long-term guidance for about $1.2 billion in biosimilar revenue by 2030. Patel said the path to that target includes existing products generating about $100 million, recently approved products expected to contribute next year, and upcoming launches such as XOLAIR, Orencia and Nplate biosimilars. He also pointed to an undisclosed product that Kashiv has worked on for seven years, though he said Amneal is waiting for FDA feedback before discussing it further.

Private-Label Channel Seen as Key to Biosimilar Uptake

Patel said the biosimilars market is changing as pharmacy benefit managers and private-label channels become more important. He said Amneal already has long-standing relationships with those customers through its small-molecule generics business, supplying more than 300 medicines.

Patel said roughly 70% of the biosimilar market is moving toward private label, which he said can create immediate access to volume once a product launches and patent settlements are in place. He contrasted that with earlier biosimilar launches, where manufacturers had to build demand more slowly.

He also said regulatory changes could reduce biosimilar development timelines by at least two years and cut costs by roughly half. Patel said Amneal’s average global development cost could be around $75 million, and potentially closer to $60 million, compared with prior costs that he said were around $150 million.

Generics Pipeline Includes Complex Products

Patel said Amneal’s affordable medicines segment is broader than traditional tablets and capsules, highlighting respiratory products, long-acting depots, hospital products, ophthalmics and injectable drugs.

He cited risperidone as a recent launch and octreotide as a pipeline product. He also discussed ready-to-use hospital products that convert compounded versions into FDA-approved products made under sterile GMP manufacturing standards. Patel said Amneal recently entered the market with romidepsin after addressing stability challenges.

Among near-term launches, Patel highlighted lanreotide, saying approval is expected in the third quarter or earlier and that customers have indicated demand. He said Amneal built a dedicated facility for the product over seven years because of its viscosity and device requirements. Patel also discussed iohexol, saying additional strengths are coming and that Amneal expects to be the only generic competitor alongside GE for the foreseeable future.

Specialty Products Gain Traction

In the specialty segment, Patel said CREXONT has reached 23,000 patients about 15 months after launch. He said 80% of conversions are coming from immediate-release therapy and that the company’s long-term goal is to make CREXONT a first-line therapy for Parkinson’s disease patients.

Patel said Amneal continues to expect CREXONT to reach its previously discussed $300 million to $500 million opportunity, with potential toward the higher end. He also said international launches are expected through partners, including in India and Europe.

Patel was more optimistic than prior expectations for Brekiya, an auto-injector used for severe migraine and cluster headache episodes. He said Amneal had previously discussed a $50 million to $100 million opportunity but now believes it could be $100 million to $200 million. Patel said the product allows patients to self-administer treatment rather than going to an emergency room.

On RYTARY generic competition, Patel said the timing remains “TBD.” He also said Amneal plans to file an NDA by the end of this year for an undisclosed men’s health product, which could launch by the end of 2027.

Pfizer Partnership and Capital Allocation

Patel said Amneal’s obesity-related partnership with Pfizer is progressing, with teams already working together. He said Amneal is building two peptide manufacturing facilities: a smaller facility expected to come online soon and dedicated to Pfizer’s product, and a larger API facility expected to be completed by the end of next year.

Patel said the Pfizer-related opportunity is not included in Amneal’s current guidance and would be more meaningful from 2030 onward. He said Amneal currently has exclusive rights in India and 17 other countries, and that updates to the agreement could come in the next couple of months.

On capital allocation, Patel said Amneal wants to operate below three times leverage. He said leverage may temporarily rise to around 3.5 to 3.6 times but expects it to move below three. Once there, he said free cash flow could be directed largely toward specialty investments, while biosimilars R&D and capital spending continue.

“We don’t need to buy anything in,” Patel said, though he added that Amneal may still pursue some mergers, acquisitions and in-licensing opportunities as part of a long-term strategy.

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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