Amphastar Pharmaceuticals, Inc. Q4 FY2025 earnings call

2025 was pivotal with Saximi's double-digit growth, FDA approvals for iron sucrose and teriparatide, and recent FDA approval of ipatropium bromide HFA inhalation aerosol. Pipeline advanced with novel peptides and a corticotropin program. Commercial side attentive to legacy product competition, prioritizing strong growth opportunities. Performance driven by resilient commercial momentum, strategic pipeline progress, and disciplined operational execution with U.S. manufacturing advantage. Achieved regulatory milestones like iron sucrose, teriparatide, and ipatropium bromide HFA approvals. Expanded proprietary pipeline with high-value assets. On commercial side, focused on strongest growth opportunities and managed legacy product pressures.

Full-year net revenues were $719.9 million. Vaccine generated $185.4 million in revenue, up 12% year-over-year. Primatine Mist had sales rising 7% to $108.7 million. Iron sucrose contributed $4.4 million following its August launch. Albuterol saw strong growth. Full-year revenue declined modestly by 2%, reflecting headwinds in legacy products. Vaccine: $185.4 million, 25.8% of total revenue. Primatine Mist: $108.7 million, 15.1% of total revenue. Iron sucrose: $4.4 million, 0.6% of total revenue.

2026 vaccine expects mid-single-digit unit growth in U.S., offset by planned reduction in international volume, no price increases. Primatine Mist expects mid to high single-digit unit growth, 5% price increase in second quarter. Ipatropium bromide HFA planned launch in early second quarter to be a meaningful contributor. Anticipates increased contributions from third-party API sales. Expect consolidated revenue growth in mid- to high-single-digit range. Gross margins lower due to pricing pressure on glucagon, epinephrine, phytonadione and higher input costs. Selling and marketing expense percentage of sales to increase slightly. General and administrative spending flat as percentage of sales. R&D to wrap up clinical trials and material purchases for inhalation and proprietary pipeline, significant increase in capital spending from Rancho Cucamonga expansion. Plan to finance expansion with cash flow from operations, utilize portion of cash for stock buyback, and look for business development opportunities.

Competitive pressures in legacy products like epinephrine and glucagon. Impact of exiting unprofitable international markets. Higher input costs including labor and supplier-related increases. Uncertainty in business development opportunities affecting cash utilization for stock buyback.

Q: On AMP110, any FDA conversations?

A: Not engaged yet, internally discussing and putting program on paper.

Q: Business development priorities?

A: Focus on endocrinology, oncology, ophthalmology, immunology where have presence or planned presence.

Q: Vaccine 2026 expectations?

A: Mid-single digit unit growth in U.S., international volume reduction in second half.

Q: AMP007 opportunity?

A: Meaningful market share with 180 days exclusivity, no visibility on authorized generic, market stabilized.

Q: Gross margins 2026?

A: Lower due to pricing pressure on legacy high-margin products and input costs.

Q: Stock buyback proportion?

A: Likely another authorization later, dependent on business development, may slow if need cash for opportunities.

Q: Primatine Mist competition and lifecycle?

A: Patent expired, no current competition, strong brand equity, developing new formulation with patents.

Q: Cadence of filings?

A: Expect late this year/early next year two filings, total three next year, focus on inhalation products.

Q: Nanjing NGS licensed assets?

A: Preclinical stage, prepping packages for early agency conversation, new drugs going through NDA process, optimistic on expedited pathways for oncology products.