Inquired about the IMS warning letter, revenue exposure, next FDA steps, potential production line shutdowns, and the progress on recovering BAQSIMI 340B double-dipping discounts.

IMS sales are about a third of corporate sales, but no stop in shipping or production is expected, though quality steps have caused small delays. The company responded to the FDA in late July, is working with a third-party consultant, and will provide routine updates. Shutdowns are unlikely but possible. For BAQSIMI 340B, about 50% of the targeted 80% reduction in double-dipping has been achieved since implementing a consultant in May. “IMS makes, the sales are probably about a third of our overall corporate sales on a big picture. However, we are still shipping there. We don't expect to stop shipping there. We still are producing at the same rate that we've been. We have taken some quality steps which have slowed down some of the releases, some of the batches right now to make sure that they've gone through an extra quality review, so that's led to a small delay right now for that.”

Inquired about the early market share for generic Atrovent (Ipratropium Bromide) relative to the 50%-80% goal, and if Glucagon sales are stabilizing or returning to growth.

Generic Atrovent is closing in on the 50%-80% market share goal and the launch has gone well. Glucagon's rate of decline is expected to diminish, with the worst of the decline over, but it is not expected to return to growth. The diagnostic portion of the market may grow slightly, but the anti-hypoglycemia portion will continue to decline. “Generic Atrovent, we've got a nice market share, and we are closing in on that goal range that we have put out there, but we're not quite there yet. We're really happy with where we are at this point, and that product launch has gone really well for us.”

AMPH

Amphastar (AMPH) Q2 FY26 earnings call: guidance and Q&A

Q: Asked if BD priority is immediately accretive commercial products or late-stage assets requiring development, and if the company would establish new commercial organizations in new verticals.

The strong preference is for immediately accretive or late-stage assets that would be accretive within a year, especially after in-licensing early-stage products last year. New commercial verticals would be considered only in areas where the company has planned products, such as oncology, ophthalmology, immunology, and endocrinology, leveraging existing or planned infrastructure. “Right now, because we in-licensed 3 products last year that are early stage, our real focus and what we prefer to look at are things that would be either immediately accretive or accretive to earnings within a year. That's the strong preference.”

Earnings call· Jun 2026 (Q2 FY26)· Health Care· Aug 6, 2026

Source: earnings call transcript

Executive summary

Amphastar Q2 FY26 — Strong Commercial Portfolio Performance and Pipeline Advancement

Amphastar delivered improved financial performance in Q2 FY26, driven by continued demand for key commercial products and successful new launches. The company is actively advancing its complex generic and proprietary pipelines, while also addressing an FDA warning letter at its IMS facility and navigating competitive pressures on certain products. Management reaffirmed its full-year corporate sales guidance.

Highlights

Revenue increased 5% to $183.9 million year-over-year.
BAQSIMI total prescriptions increased approximately 17% compared to the prior year quarter.
Gross margins expanded to 51% of revenues in Q2 FY26 from 50% in Q2 FY25.
Successful launch of Ipratropium Bromide Inhalation contributed $8.4 million in sales.
Achieved the first BAQSIMI net sales milestone, exceeding $175 million ($178.3 million) and triggering a $100 million payment to Eli Lilly.

Concerns

BAQSIMI net sales decreased 3% to $45.5 million due to pricing, rebates, and commercial dynamics.
Primatene sales declined 8% to $21 million due to timing of customer purchases.
Glucagon sales decreased 42% to $11.9 million due to increased competition.
IMS facility received an FDA warning letter, expecting $2 million to $3 million per quarter in increased remediation expenses and a slight slowing of sales.

Guidance & targets

Category	Target	Timeline	Confidence
Corporate sales growth	mid-single digit to high single-digit sales growth high materiality	FY26	High
IMS facility remediation expenses	increase by $2 million to $3 million per quarter medium materiality	next several quarters	High
IMS facility capital expenditures	increase at this facility, but no change to previously communicated capital expenditure profile medium materiality	ongoing	High
IMS facility sales	slight slowing of sales medium materiality	ongoing	Medium
R&D expense	tick up a little bit as a percentage of sales low materiality	going forward basis	Medium

Segment performance

Segment	Revenue	YoY	QoQ	Margin
Total Company Total revenues for the second quarter, reflecting sequential and year-over-year growth.	$183.9M	5%	—	—
BAQSIMI Net sales decreased primarily due to pricing, rebates, and commercial dynamics, including higher 340B pharmacy discounts. Strong prescription growth continues to reinforce long-term strength. Total prescriptions: +17% YoYUnits sold contribution: +$6.9MPricing impact: -$8.1M	$45.5M	-3%	—	—
Primatene MIST Sales decline attributed to timing of customer purchases and shipments associated with pricing discussions, believed to be temporary channel-related effects. Retail performance remained healthy. In-store sales: increased YoY and QoQ	$21.0M	-8%	—	—
Epinephrine Weakness in vial product offset by increased demand for pre-filled syringe product.	—	relatively flat	—	—
Glucagon Sales declined due to increased competition. The rate of decline is expected to diminish, but it is not expected to return to growth.	$11.9M	-42%	—	—
Ipratropium Bromide Inhalation Newly launched in April, contributing to growth with strong initial sales. Expected to be an attractive long-term opportunity.	$8.4M	—	—	—
Other Products Increase primarily due to recently launched products (Iron Sucrose, Teriparatide, Albuterol), higher demand for phytonadione and sodium bicarbonate due to supplier shortages, and increased sales of API from AMP subsidiary. Iron Sucrose sales: $3.5MTeriparatide sales: $4.5MAlbuterol sales increase: +$2.4M	$66.2M	25%	—	—

Deals & partnerships

Eli Lilly BAQSIMI asset purchase agreement $100M

Achieved the first annual BAQSIMI net sales milestone under the asset purchase agreement.

Risks & headwinds

Competitive dynamics in generic pharmaceutical market Q2 FY26

Glucagon sales declined 42% to $11.9 million

Mitigation:Continuing to diversify commercial portfolio and advance new products.

FDA warning letter for IMS facility next several quarters

Expenses to increase by $2M-$3M per quarter for next several quarters; slight slowing of sales from IMS

Mitigation:Implementing corrective actions, responding to FDA, working with third-party consultant, strengthening quality systems. No material adverse effect on overall business anticipated.

BAQSIMI pricing, rebates, and 340B discounts Q2 FY26

Net sales decreased 3% to $45.5 million; lower average selling prices negatively impacted sales by approximately $8.1 million

Mitigation:Engaged a third party to support data-driven identification, validation, and resolution of potential 340B duplicate discounts, achieving 50% of 80% target reduction.

Primatene MIST sales decline due to channel dynamics Q2 FY26

Sales down 8% to $21 million

Mitigation:Believed to be temporary channel-related effects rather than a change in consumer demand; retail performance remained healthy.

What to watch in Q3 FY26

IMS facility remediation progress

next quarter

Current FDA warning letter received; remediation underway with $2M-$3M/quarter increased expenses and slight sales slowing expected

Target Progress on corrective actions, stability of sales, and expense management

Why it matters

The IMS facility warning letter could impact manufacturing and sales, and the associated costs will affect profitability. Monitoring progress is crucial for operational stability.

Due to remediation efforts at our IMS facility, we expect expenses there will increase by $2 million to $3 million per quarter for the next several quarters. We also expect a slight slowing of sales from IMS as we concentrate on addressing corrective actions, thus improving the quality and manufacturing systems.

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Q&A highlights

Asked about the outlook for R&D and SG&A spend, and the drivers of gross margin volatility, seeking a baseline for H2.

Management attributed Q1 gross margin decrease to BAQSIMI double-dipping, which was partially mitigated in Q2 by new procedures and a third-party consultant. Q2 benefited from the launch of higher-margin Ipratropium Bromide. Expects Q3 gross margins to be similar to Q2, with higher BAQSIMI sales offsetting IMS costs. SG&A and selling expenses are expected to be comparable to Q2, while R&D is projected to tick up as a percentage of sales.

“On a going forward basis, I would expect to see the coming quarter similar to this quarter, because remember, we'll have higher BAQSIMI sales next quarter, those higher sales should offset some of the costs that we're expecting at IMS. Additionally, on the G&A and selling expense, I think the second quarter is also a good comp for those. The R&D expense, we do expect that to tick up a little bit as a percentage of sales on a going forward basis.”

asked by Ekaterina Knyazkova · answered by William Peters

2 min read 5 chapters

Detailed narrative

Strategic Growth Pillars and Commercial Portfolio

Amphastar's strategy centers on three pillars: optimizing its branded and differentiated commercial portfolio, advancing its complex generic and biosimilar pipeline, and progressing proprietary development programs. Key products like BAQSIMI and Primatene MIST are central to this strategy, demonstrating continued consumer demand.

BAQSIMI saw a 17% increase in total prescriptions year-over-year, reinforcing confidence despite a 3% net sales decline due to pricing dynamics. Primatene MIST maintained strong retail performance, with sales decline attributed to temporary channel effects rather than demand.

Manufacturing and Regulatory Compliance

The company continues to invest in its U.S. manufacturing network, strengthening quality, efficiency, and capacity. The successful launch of Ipratropium Bromide in April further demonstrates its capability in complex generic products. However, the IMS facility received an FDA warning letter in December 2025.

Remediation efforts are underway, with expected increased expenses of $2 million to $3 million per quarter and a slight slowing of sales, though no material adverse effect on overall business is anticipated. The company is working closely with the FDA to address observations.

Pipeline Advancement and Milestones

Amphastar achieved important regulatory and clinical milestones across its pipeline. The insulin aspart biosimilar and interchangeable program is on track for potential commercialization in 2027. Proprietary programs are also progressing, with Phase I initiated for AMP-101 (epinephrine nasal), non-clinical studies for AMP-109 (targeted oncology) ahead of an anticipated IND submission, and ongoing development for AMP-110 (synthetic human corticotropin) and AMP-107 (eye drop for wet AMD/DME) towards future IND submissions.

The insulin aspart bioavailability study has been completed.

Financial Performance and Cost Structure

Second-quarter revenues increased 5% to $183.9 million, driven by new launches like Ipratropium Bromide and growth in other products, partially offset by declines in BAQSIMI and Glucagon. Gross margins improved to 51%, benefiting from higher-margin new products. Selling, distribution, and marketing expenses increased 30% to $13.3 million due to BAQSIMI marketing and freight.

General and administrative spending rose 30% to $18.2 million from legal, personnel, and ERP implementation costs. R&D expenditures increased 10% to $22.2 million, primarily from clinical trial expenses for the insulin pipeline.

Capital Allocation and Business Development

The company repurchased approximately $45 million worth of shares during the quarter. A significant milestone was achieved with BAQSIMI net sales exceeding $175 million ($178.3 million) in the third contract year, triggering a $100 million milestone payment to Eli Lilly due in Q3 2026.

In terms of business development, Amphastar prefers immediately accretive or late-stage assets, but is open to early-stage opportunities with lower upfront costs. New commercial verticals would likely be within existing planned product areas like oncology, ophthalmology, immunology, and endocrinology.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.