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Baqsimi continues to grow in the U.S. but is facing slight pricing pressure from payer mix shifts; Amphastar expects roughly $175M in Baqsimi sales this year which would trigger a $100 million payment in August and has additional milestones tied to higher cumulative sales.

Primatene Mist is tracking for high single- to low double-digit growth, supported by advertising and physician sampling, and remains the only FDA‑approved OTC asthma reliever with management viewing generic competition as unlikely.

Management reiterated a mid- to high-single-digit revenue growth target with modestly higher operating expenses, plans to launch AMP-007 in early Q2 and key diabetes/insulin biosimilar programs in 2027, and holds a balance sheet of about $600M debt and $300M cash (roughly 2x leverage) that could support selective M&A.

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Amphastar Pharmaceuticals (NASDAQ:AMPH) executives outlined growth drivers, competitive pressures, and pipeline priorities during a fireside chat at Needham & Company’s 25th Annual Healthcare Conference. The discussion featured CFO Bill Peters, Senior VP of Corporate Communications Dan Dischner, and Executive VP of Clinical and Regulatory Tony Marrs, moderated by Needham Senior Analyst Serge Belanger.

Management described Amphastar as a “diversified, branded, and complex generic development and manufacturing company” built on a vertically integrated model. Executives said 2025 showed the strategy working, citing continued scaling of branded products Baqsimi and Primatene Mist, durability in the hospital and injectable portfolio, and contributions from recent launches.

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Peters said the fourth quarter benefited from strong demand for Baqsimi and solid performance from Primatene Mist, along with contributions from newly launched or approved products such as iron sucrose and, to a lesser extent, teriparatide, which launched at the end of December. He also said Amphastar benefited from certain product shortages during the quarter due to its “strong domestic manufacturing capabilities,” but noted that competition in epinephrine vial and glucagon offset some of the upside.

While Amphastar does not provide formal guidance, Peters reiterated the company has discussed “mid to high single-digit revenue growth” for the year, calling it achievable. He said operating expenses are expected to rise modestly, driven by higher cost of goods, increased R&D spending tied to proprietary product development, and a “slight uptick” in G&A related to a new ERP implementation, which he characterized as temporary.

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On quarterly cadence, Peters said certain products exhibit seasonal strength, with Baqsimi and glucagon typically strongest in the third quarter. Primatene Mist, he said, tends to be stronger in the first and fourth quarters.

Asked about the impact of storms on first-quarter results, Peters said Amphastar did not see disruptions, adding that wholesalers often carry higher inventory levels into January as a precaution.

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Peters described Baqsimi as continuing to grow in the U.S., driven by marketing, broader awareness of nasal glucagon, and efforts to improve prescription renewals for an emergency product that may go unused. He noted Amphastar has seen a “slight pricing decline” in the U.S. due to payer mix shifts, including higher 340B volumes, and said the impact began in the third quarter and became more visible in the fourth quarter, continuing into the first quarter.

Internationally, Peters said Amphastar plans to discontinue Baqsimi in a “handful” of unprofitable countries, which he said will reduce reported revenue but improve profitability. He emphasized the exits will be gradual and country-by-country, depending on notice periods and remaining inventory levels. Peters added that none of the discontinued markets are among the company’s top three countries and that U.S. revenue was about 80% last year and could rise closer to 85% as domestic growth outpaces overseas sales.

On deal-related payments, Peters said he expects Amphastar to hit $175 million in Baqsimi sales this year, which would trigger a $100 million payment in August. He also outlined additional milestones: two annual milestones tied to reaching $200 million in sales for the first and second time within the first five contract years (July 1 to June 30), plus a cumulative $950 million sales milestone over the first five years that would require an additional $150 million payment if achieved.

Management maintained its previously stated Baqsimi peak sales target of $250 million to $275 million, with Peters saying an increase is possible but not reflected currently. He argued growth can come from both an expanding market and higher patient compliance, noting that when Amphastar acquired Baqsimi, about 10% of insulin users filled a glucagon prescription; he said that figure is now about 12%. Peters said payer coverage is strong (he cited “97%-98%”), but awareness and annual refill behavior remain key bottlenecks. Belanger suggested EpiPen as a comparison, and Peters agreed it is “the best comparable,” though he said the company is not pursuing school or workplace stocking initiatives at this time.

On the MannKind collaboration, Peters said the partnership has gone “very well,” with a noticeable pickup in sales after MannKind began marketing the product. Dischner said the expanded reach helps reinforce Baqsimi’s differentiation as “the only nasal powder glucagon ready to use.” The company did not disclose sales force sizes, but management said MannKind’s sales force is larger, while Amphastar’s internal Baqsimi team is dedicated solely to that product.

Dischner said Primatene Mist is tracking for “high single to low double-digit growth,” citing a strong 2025 and expectations for similar performance in 2026. He highlighted a physician sampling program designed to increase awareness and said Amphastar expects to implement a “small price increase” in the second half of the year. He added that Primatene Mist remains the only FDA-approved over-the-counter asthma relief medication and said growth is broadly across retail channels, supported by advertising that began in April.

On the prospect of a generic competitor, Dischner said Amphastar believes the economics and regulatory pathway for an OTC product make it unlikely, adding that while Primatene Mist’s patent has expired, the company has not seen signals of a competing product under FDA review.

On legacy injectables, Peters said glucagon continues to face competitive pressure following a new entrant at the end of 2025, and he expects glucagon sales to decline further this year, calling it the “most significant drag” on growth. For epinephrine, Peters said the multi-dose vial has been pressured by multiple entrants but is closer to having largely realized its decline. He said the prefilled syringe could increase this year, noting a competitor resumed shipments last year but stopped again late in the year and has not returned to the market.

Peters said iron sucrose is tracking near expectations, which he described as “about a $10 million a year sales product,” despite coming in slightly below that run rate in the fourth quarter due to timing. He said teriparatide, launched at the end of December, is expected to be smaller due to lower unit volume. He also said Amphastar plans to launch AMP-007 in the “early second quarter,” while noting uncertainty about whether an authorized generic might enter.

Discussing AMP-007’s opportunity, Peters cited IQVIA sales of $112 million for the branded market but said Amphastar applies a 30% discount to IQVIA brand numbers, implying a market closer to $80 million before typical generic price reductions and market share assumptions. He added that the presence or absence of an authorized generic could meaningfully influence where Amphastar lands within its previously discussed mid- to high-single-digit growth range.

Marrs addressed pipeline timing for diabetes programs, stating AMP-018 is expected to launch in 2027 and noting the space is crowded with several generic approvals, limiting expected revenue contribution, though he said it supports Amphastar’s diabetes portfolio. He also said Amphastar’s insulin biosimilar AMP-004 remains on track for a 2027 launch and should represent a larger opportunity.

On other programs, Marrs said the company’s intranasal epinephrine remains in clinical development. For REXTAVY (intranasal naloxone), he said it is already approved as a prescription product and Amphastar is working with the FDA on converting it to OTC, describing the process as involving label comprehension studies and label modifications. Marrs said Amphastar does not expect the OTC naloxone opportunity to be financially meaningful due to a crowded market but intends to proceed.

Regarding early-stage assets in-licensed from China, Marrs said it is too early to rank the programs, but he called the preclinical data encouraging and said Amphastar has begun engaging with the FDA on some molecules. He pointed to AMP-109 data shown in the company’s slide deck, describing “very strong anti-tumor activity” including “99% tumor reduction” in a pancreatic cancer animal model.

Management also discussed business development, with Marrs saying Amphastar is actively evaluating later-stage or marketed products to “bridge” the gap before earlier programs mature, focusing on endocrinology and areas tied to its early proprietary pipeline: oncology, immunology, and ophthalmology. Peters said Amphastar could consider a deal comparable in size to Baqsimi if the fit were similarly strong, but emphasized financial discipline and noted leverage of a little over two times under covenant calculations.

Peters said Amphastar has $600 million in debt and $300 million in cash, and said net leverage is lower when considering net debt relative to EBITDA. He argued the company’s balance sheet supports continued investment and potentially additional debt for the right asset, particularly one already generating EBITDA.

In closing remarks, Peters and Dischner said they believe investors may be underappreciating the durability and long-term cash generation of Baqsimi and Primatene Mist and may misinterpret Amphastar’s push into proprietary products as a pivot rather than an expansion of established capabilities in complex products and peptides.

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.

The article "Amphastar Pharmaceuticals Highlights Baqsimi Milestones, Primatene Growth at Needham Conference" was originally published by MarketBeat.