Amphastar Pharmaceuticals, Inc.: Q3 FY2026 earnings call
What management said about Q3 FY2026, from the documents filed with the SEC on 5 November 2026: press release. Guidance figures: 1 raised. The quarter’s numbers.
Key takeaways
- Revenue rose 8% on higher sales: Net revenues were $207.6 million, up 8% from $191.8 million a year earlier. Gross profit rose 1% to $99.6 million, and income from operations was $50.8 million against $25.3 million. Source
- GAAP EPS rose on lower G&A: GAAP net income was $37.8 million, or $0.87 diluted EPS, against $17.4 million and $0.37 a year earlier. The prior year carried a $23.1 million litigation provision. Source
- BAQSIMI sales rose on unit volume: BAQSIMI sales rose 10% to $58.8 million. Unit volume added $7.4 million, partly offset by a lower average selling price from gross-to-net changes, which the company put at about $2.2 million. Source
- Gross margin fell to 48.0%: Gross margin was 48.0% against 51.4%, while cost of revenues rose 16% to $108.0 million. The company cited lower average selling prices for BAQSIMI, glucagon and the epinephrine multi-dose vial. Source
- IMS remediation slowed epinephrine releases: Epinephrine sales fell 19% to $15.3 million, as lower pre-filled syringe volume followed slower product releases during ongoing remediation at IMS, which operates under an FDA warning letter. Source
- Remediation and expansion raised costs: The company cited higher manufacturing expenses from IMS remediation under the FDA warning letter and from expanding its Rancho Cucamonga, CA facility, both recorded in cost of revenues. Source
- Buyback program raised by $50 million: The board authorized a $50 million increase to the share buyback program on November 4, 2026, expected to continue for an indefinite period. Source
“Our third quarter results demonstrate the strength of Amphastar’s diversified portfolio and the commercial platform we have built.”
Dr. Jack Zhang, Amphastar’s President and Chief Executive Officer
Guidance
| Area | Period | Figure | Against last quarter |
|---|---|---|---|
| Share buyback Source | Indefinite | $50 million increase | Raised |
What changed from last quarter
- Guidance raised: The share buyback authorization was increased by $50 million on November 4, 2026. Source
Results and growth drivers
- Revenue rose 8% on higher sales: Net revenues were $207.6 million, up 8% from $191.8 million a year earlier. Gross profit rose 1% to $99.6 million, and income from operations was $50.8 million against $25.3 million. Source
- GAAP EPS rose on lower G&A: GAAP net income was $37.8 million, or $0.87 diluted EPS, against $17.4 million and $0.37 a year earlier. The prior year carried a $23.1 million litigation provision. Source
- Adjusted EPS $1.14 versus $0.93: Adjusted non-GAAP net income was $49.3 million, or $1.14 per diluted share, against $44.7 million and $0.93. Adjusted figures exclude amortization, share-based compensation, impairment and litigation items. Source
Product sales by drug
- BAQSIMI sales rose on unit volume: BAQSIMI sales rose 10% to $58.8 million. Unit volume added $7.4 million, partly offset by a lower average selling price from gross-to-net changes, which the company put at about $2.2 million. Source
- Primatene MIST grew on price and demand: Primatene MIST sales rose 9% to $31.5 million. A price increase in the second quarter of 2026 added $1.6 million, and unit volume added $1.0 million as in-store demand grew. Source
- Lidocaine sales rose on supplier shortages: Lidocaine sales rose 29% to $16.6 million on higher unit volume. The company attributed the demand increase to shortages at other suppliers. Source
- Ipratropium bromide added sales: Ipratropium bromide contributed $6.6 million following its launch in the second quarter of 2026. The prior-year quarter shows no sales for the product. Source
- Teriparatide and API sales added: Other products rose 9% to $70.2 million. Teriparatide, launched in December 2025, contributed $6.4 million, and API sales from ANP added $6.2 million, while IMS-made products declined. Source
“Record sales of BAQSIMI ® and Primatene MIST ® , together with contributions from recently launched products, supported continued revenue growth and further strengthened the foundation for our long-term strategy.”
Dr. Jack Zhang, Amphastar’s President and Chief Executive Officer
Gross margin and cost lines
- Gross margin fell to 48.0%: Gross margin was 48.0% against 51.4%, while cost of revenues rose 16% to $108.0 million. The company cited lower average selling prices for BAQSIMI, glucagon and the epinephrine multi-dose vial. Source
- New launches partly offset margin: Recently launched products, including teriparatide and ipratropium bromide, were described as higher-margin and partly offset the decline in gross margin. Source
- Operating expense lines moved: Selling, distribution and marketing rose 4% to $11.9 million on freight. G&A fell 57% to $16.8 million, and R&D fell 10% to $20.1 million after a $5.3 million licensing payment in the prior year. Source
- Non-operating costs narrowed; tax rose: Total non-operating expense was $1.7 million against $3.8 million, mainly on currency and interest rate swap mark-to-market adjustments. The income tax provision rose to $11.3 million from $4.2 million. Source
Manufacturing and FDA remediation
- IMS remediation slowed epinephrine releases: Epinephrine sales fell 19% to $15.3 million, as lower pre-filled syringe volume followed slower product releases during ongoing remediation at IMS, which operates under an FDA warning letter. Source
- Other IMS-made products declined: Sales of several products made at the IMS facility decreased because of ongoing remediation activities, partly offsetting gains elsewhere in the portfolio. Source
- Remediation and expansion raised costs: The company cited higher manufacturing expenses from IMS remediation under the FDA warning letter and from expanding its Rancho Cucamonga, CA facility, both recorded in cost of revenues. Source
“We remain focused on disciplined execution, strengthening our operations, and deploying capital in ways that we believe can create sustainable long-term value for our shareholders,”
Dr. Jack Zhang, Amphastar’s President and Chief Executive Officer
Pricing and competition
- BAQSIMI price pressure from discounts: A lower average selling price for BAQSIMI, from changes in gross-to-net discounts including chargebacks, rebates and customer mix, offset part of the unit-volume gain. Source
- Glucagon price cut by competition: Glucagon sales fell 37% to $8.6 million, mainly on a lower average selling price as competition increased. Source
Pipeline and proprietary products
- Insulin ANDA and biosimilar filed: One ANDA and one biosimilar insulin candidate are filed with the FDA, for products the company says target a combined market above $1.6 billion. Source
- Biosimilar and generic programs in development: Two biosimilar products are in development with a market above $3.5 billion, and three generic products with a market above $1.2 billion. Source
- Four in-licensed proprietary products: The proprietary pipeline includes four in-licensed products: three proprietary peptides for oncology and ophthalmology, and a fully synthetic corticotropin compound for inflammatory and autoimmune conditions. Source
- Market sizes from IQVIA data: Market size figures are based on IQVIA data for the 12 months ended September 30, 2026, supplemented by data from a branded company for one generic target. Source
Cash, shares and buybacks
- Operating cash flow was $142.5 million: Cash flow from operating activities was $142.5 million for the nine months ended September 30, 2026. Source
- Shares outstanding fell since December: Shares outstanding were 42,648,323 at September 30, 2026, against 45,645,497 at December 31, 2025, with 62,441,273 shares issued. Source
- Buyback program raised by $50 million: The board authorized a $50 million increase to the share buyback program on November 4, 2026, expected to continue for an indefinite period. Source
- Buyback aims to offset dilution: The program’s primary goal is to offset dilution from equity compensation programs. Purchases may be made in the open market or under Rule 10b5-1 plans. Source
Strategy and investment
- Investing in manufacturing and development capacity: Management said it continued advancing generic, biosimilar and proprietary programs while investing in manufacturing, quality and development capabilities for future growth. Source
- Proprietary products in several forms: The company is developing multiple proprietary products with injectable, topical and intranasal dosage forms, alongside its generic and biosimilar programs. Source
Coming up, as management said on 5 November 2026
- Buyback runs for an indefinite period: The increased share buyback program is expected to continue for an indefinite period, primarily to offset dilution from equity compensation. Source
- Repurchase timing depends on conditions: The timing and number of shares repurchased will depend on price, corporate and regulatory requirements, and other conditions. Source
Figures management reported
| Figure | Reported |
|---|---|
| BAQSIMI net revenues Source | $58.8 million, up 10% |
| Primatene MIST net revenues Source | $31.5 million, up 9% |
| Lidocaine net revenues Source | $16.6 million, up 29% |
| Epinephrine net revenues Source | $15.3 million, down 19% |
| Glucagon net revenues Source | $8.6 million, down 37% |
| Ipratropium bromide net revenues Source | $6.6 million |
| Teriparatide sales Source | $6.4 million; launched December 2025 |
| Research and development expense Source | $20.1 million, down 10% from $22.4 million |
| Insulin ANDA and biosimilar pipeline market Source | Combined market exceeding $1.6 billion |
| Biosimilar products in development market Source | Market size exceeding $3.5 billion |
| Generic products in development market Source | Market size over $1.2 billion |
Risks management discussed
- Regulatory: Remediation at the IMS facility under an FDA warning letter is ongoing and adds manufacturing expense. Source
- Operational: Slower product releases tied to IMS remediation reduced pre-filled syringe volume and epinephrine sales. Source
- Demand: Increased competition lowered the average selling price and sales of glucagon. Source
- Demand: Changes in gross-to-net discounts, chargebacks, rebates and customer mix lowered BAQSIMI average selling price. Source
Other quarters
Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.