Amphastar Pharmaceuticals Pivots to Proprietary Drugs, Biosimilars for Growth

Key Points

• Amphastar is shifting its strategy from complex generics toward proprietary drugs and biosimilars, aiming for a pipeline mix of roughly 50% proprietary products, 35% biosimilars and 15% generics.
• The company is increasing R&D spending to support that transition, with spending already around 11.9% of revenue and expected to rise as more proprietary programs advance.
• Key growth drivers include BAQSIMI, Primatene MIST and a range of early-stage pipeline assets such as AMP-101 epinephrine nasal spray and AMP-110, while Amphastar says its cash, EBITDA and credit lines can fund development through Phase 2.

Amphastar Pharmaceuticals NASDAQ: AMPH is positioning itself for a broader shift from complex generics toward proprietary medicines and biosimilars, Chief Financial Officer and Executive Vice President of Finance Bill Peters told investors at the East Coast IDEAS Conference.

Peters described Amphastar as a “fully integrated pharmaceutical company” with in-house product development, active pharmaceutical ingredient manufacturing, finished product manufacturing in the United States, and marketing and distribution capabilities. He said the company’s operating model is built around what management calls a “3 H focus”: high-quality products, high efficiency of operations and high technology to drive the pipeline.

According to Peters, Amphastar historically focused on complex generics, including enoxaparin, but has been moving its pipeline toward proprietary products that the company believes can generate more durable cash flows. He said that in 2021, roughly two-thirds of Amphastar’s pipeline consisted of generics, with 21% proprietary products and 16% biosimilars. The company set a goal to shift within five years to a mix of 50% proprietary products, 35% biosimilars and 15% generics.

“We are very close to those numbers today, and I think by the end of the year, we’ll be even closer,” Peters said.

R&D spending expected to rise as proprietary pipeline expands

Peters said Amphastar spends more on research and development than many generic drug companies, reflecting its effort to move into branded and proprietary products. He said R&D spending increased significantly last year and represented about 11.9% of revenue after a trough year in 2024. Amphastar expects that percentage to continue increasing over the next few years as it advances more proprietary programs.

The company’s technical capabilities include particle engineering, drug characterization, immunogenicity evaluation, peptide and protein development, and biosimilar work. Peters cited Primatene MIST, the only FDA-approved over-the-counter asthma inhaler, as an example of Amphastar’s formulation capabilities. He also pointed to the company’s glucagon kit, which he said was the first generic version of Eli Lilly’s product and remained the only generic on the market for four years due to its complexity.

Amphastar’s current infrastructure includes three U.S. manufacturing facilities for finished products and two overseas facilities, in China and France, for active pharmaceutical ingredient production.

Proprietary programs include epinephrine nasal spray, peptides and synthetic corticotropin

Peters highlighted several proprietary development programs, including AMP-101, an intranasal version of epinephrine for anaphylaxis that is currently in Phase 1 studies. Other early-stage programs include AMP-105, AMP-107 and AMP-109, which Amphastar in-licensed from a Chinese biotech firm last year. Peters said AMP-105 and AMP-109 are oncology programs, while AMP-107 targets wet age-related macular degeneration.

For AMP-107, Peters said Amphastar is working on an eye-drop approach that could potentially reduce reliance on injections into the eye. He described AMP-109 as a peptide-coupled docetaxel program being tested in pancreatic cancer models. Peters also discussed AMP-110, a synthetic human corticotropin that he said is similar to Acthar Gel and targets a market Amphastar expects could reach about $1 billion by the time it reaches the market.

In response to an investor question, Peters said the company intends to take proprietary programs at least through Phase 2 before evaluating whether to continue development internally or partner with a larger pharmaceutical company. He noted that later-stage oncology trials can be expensive.

“To do all of these products all through Phase 3 would probably require more money than we would be able to commit at this time,” Peters said. “I think it’ll be a good problem to have if we get to that point.”

BAQSIMI and Primatene MIST remain key branded products

Peters said Amphastar has achieved branded product success with BAQSIMI, an intranasal glucagon product acquired from Eli Lilly that treats hypoglycemia. Amphastar sells BAQSIMI in the United States and 25 other countries. Peters said the company forecasts peak annual BAQSIMI sales of $250 million to $275 million and long-term incremental adjusted peak EPS of $2 to $2.50 per share from the product.

For Primatene MIST, Peters said Amphastar is increasing physician sampling and launching a new advertising campaign. The product generated $109 million in sales last year, making it Amphastar’s second-largest product, and the company is forecasting high-single-digit growth this year. Amphastar is also developing a lower-global-warming-potential propellant formulation and has received one patent related to that formulation, with another in development.

Biosimilars, inhalation products and diabetes portfolio

Amphastar’s biosimilar pipeline includes insulin aspart, recombinant human insulin and AMP-028, an undisclosed biosimilar for which Peters said the company believes it has a strategic advantage in active pharmaceutical ingredient production. The company expects a commercial launch of insulin aspart in 2027 and plans to file recombinant human insulin with the FDA in the first half of next year.

Peters also discussed a generic GLP-1 program, which he said targets a molecule with estimated U.S. IQVIA sales of about $300 million. In response to a question, he said IQVIA figures often overstate actual sales and that Amphastar expects the market to be crowded with generic entrants. He said the product could be incremental to sales but is not expected to be a major growth driver.

The company recently launched ipratropium bromide in April after approval in February, and Peters said Amphastar is currently the only generic seller of that product. He described it as a significant launch for 2026.

Capital structure supports near-term R&D plans, CFO says

During the question-and-answer session, Peters said Amphastar has the capital structure to support its R&D plans through Phase 2 for its key proprietary programs. He said the company has $285 million in cash, an undrawn $200 million revolving debt facility in the United States and generates more than $200 million in annual EBITDA.

Peters said Amphastar carries about $600 million of debt, including a $250 million term loan and $345 million of convertible debt securities. He said the company believes it can refinance the debt when due, likely paying down some portion while refinancing the rest.

“With the cash we can generate right now, we can take care of the R&D responsibilities that we have for the next five years,” Peters said.

About Amphastar Pharmaceuticals NASDAQ: AMPH

Amphastar Pharmaceuticals, Inc is a specialty pharmaceutical company headquartered in Rancho Cucamonga, California. Founded in 2004, Amphastar focuses on the development, manufacturing and commercialization of injectable and inhalation products. The company's manufacturing facilities in California produce both generic and proprietary formulations designed to address urgent and chronic medical conditions.

Amphastar's portfolio includes a range of injectable generics such as epinephrine, naloxone and lidocaine, serving hospital, emergency medical and retail pharmacy channels.

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