Innoviva, Inc. 8-K

Summary

Q3 2026 results with FY2026 U.S. net product sales guidance. U.S. net product sales grew 45% Y/Y to $43.3M, helping lift operating income, but lower royalty revenue and the timing of inventory sales to ex-U.S. partners left total revenue down 1.6% Y/Y to $106.1M.

Innoviva said it remains on track to achieve FY2026 U.S. net product sales of at least $150M as it expands its specialty therapeutics business.

Developments

• NUZOLVENCE, a first-in-class, single-dose oral antibiotic for uncomplicated urogenital gonorrhea, is commercially available in the U.S.; initial efforts are focused on building market access, distribution and dispensing infrastructure.
• Updated 2026 Infectious Diseases Society of America guidance recommends XACDURO, an antibiotic for invasive carbapenem-resistant Acinetobacter baumannii infections, with imipenem or meropenem as the preferred treatment; high-dose ampicillin-sulbactam combinations are described as temporary bridging therapy when XACDURO is not immediately available.
• The CDC’s 2026 antimicrobial resistance report put four pathogens in its highest-threat category; Innoviva says its portfolio includes treatments targeting two of them: XACDURO and NUZOLVENCE.
• XACDURO, ZEVTERA and NUZOLVENCE were finalists for the 2026 Prix Galien USA “Best Pharmaceutical Product” award; this is the third consecutive year an Innoviva Specialty Therapeutics product has been recognized.

Key Figures

• The $73.9M quarterly net loss primarily reflected $139.5M in net unfavorable fair-value changes in equity-method and other equity and long-term investments, mainly due to a decline in Armata Pharmaceuticals’ stock price. Innoviva’s strategic healthcare investments were valued at $535.5M at 9/30/2026, including $323.7M in Armata.
• Operating income increased on higher U.S. product sales, partly offset by higher operating expenses supporting commercial expansion.
• Innoviva repurchased 1.23M shares for $26.3M under its $125M buyback program, about 4.5% of its $581.4M quarter-end cash. Since the program began, it had repurchased 3.83M shares for $82.7M. Royalty and product-sale receivables were $102.1M at quarter-end.

Guidance

• FY2026 U.S. net product sales: at least $150M; Direction: —.