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    AMPH
    Earnings call· Jun 2026(Q2 FY26)

    Amphastar Pharmaceuticals Q2 FY26 earnings call AMPH

    Aug 6, 2026 Source

    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

    5

    • 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

    4

    • 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

    5
    CategoryTargetConfidence
    Corporate sales growth
    mid-single digit to high single-digit sales growth
    high materiality
    High
    IMS facility remediation expenses
    increase by $2 million to $3 million per quarter
    medium materiality
    High
    IMS facility capital expenditures
    increase at this facility, but no change to previously communicated capital expenditure profile
    medium materiality
    High
    IMS facility sales
    slight slowing of sales
    medium materiality
    Medium
    R&D expense
    tick up a little bit as a percentage of sales
    low materiality
    Medium

    Segment performance

    7
    SegmentRevenueYoYQoQMargin
    Total Company
    Total revenues for the second quarter, reflecting sequential and year-over-year growth.
    		$183.9M5%——
    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
    		$66.2M25%——

    Operational metrics

    9
    Gross margin
    51%vs 50% in Q2 FY25
    Q2 FY26

    Gross margins increased due to product mix and new launches.

    Selling, distribution, and marketing expenses
    $13.3M+30% YoY
    Q2 FY26

    Increased from $10.2 million in Q2 FY25, primarily due to increased marketing efforts for BAQSIMI and higher freight expenses.

    General and administrative spending
    $18.2M+30% YoY
    Q2 FY26

    Increased from $14 million in Q2 FY25, driven by higher legal expenses, salary and personnel-related expenses, and ERP system implementation.

    Research and development expenditures
    $22.2M+10% YoY
    Q2 FY26

    Increased from $20.1 million in Q2 FY25, primarily due to an increase in clinical trial expense, largely for the insulin pipeline.

    Non-operating expense
    $1.2Mvs $2.8M in Q2 FY25
    Q2 FY26

    Primarily due to foreign currency fluctuations and mark-to-market adjustments related to interest rate swap contract.

    Adjusted net income
    $40.8Mrelatively flat vs $40.9M in Q2 FY25
    Q2 FY26

    Adjusted earnings excludes amortization, equity compensation, and one-time events.

    Adjusted EPS
    $0.91vs $0.85 in Q2 FY25
    Q2 FY26

    Adjusted earnings excludes amortization, equity compensation, and one-time events.

    Share repurchase
    $45M
    Q2 FY26

    Accelerated share repurchase program during the quarter.

    BAQSIMI 340B double-dipping recovery
    50%of 80% target
    Q2 FY26

    Progress made in reducing the impact of 340B duplicate discounts after engaging a third party in May.

    Industry KPIs

    10
    MetricValueDetails
    Prescription volume17%%
    EPS revenue guidancemid-single digit to high single-digit sales growth%
    Pricing policy impact—
    Product franchise net sales$45.5MUSD
    Pipeline clinical milestones—
    Regulatory approvals filings—
    Therapeutic drug market shareclosing in on 50%-80% goal%
    Price volume mix decomposition—
    Clinical trial efficacy safety datacompleted
    Business development capacity deal appetite—

    Deals & partnerships

    1
    Eli LillyBAQSIMI asset purchase agreement$100M

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

    Risks & headwinds

    4
    Competitive dynamics in generic pharmaceutical marketQ2 FY26

    Glucagon sales declined 42% to $11.9 million

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

    FDA warning letter for IMS facilitynext 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 discountsQ2 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 dynamicsQ2 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

    5

    IMS facility remediation progress

    next quarter
    CurrentFDA warning letter received; remediation underway with $2M-$3M/quarter increased expenses and slight sales slowing expected
    TargetProgress 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.

    Q&A highlights

    5

    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 read5 chapters

    Detailed Narrative

    01

    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.

    02

    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.

    03

    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.

    04

    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.

    05

    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.

    AI-generated summary of the company’s earnings call. Not investment advice.