Innoviva Q2 revenue $67.3mln, IST sales up 54% YoY to $29mln.

• Innoviva reports Q2 2025 financial results, $67.3mln revenue • IST U.S. net product sales reach $29mln, 54% YoY growth • ZEVTERA launched in U.S., Zoliflodacin NDA accepted by FDA • PDUFA date set for December 15, 2025

Innoviva Inc. (NASDAQ: IVA) reported its Q2 2025 financial results, showcasing robust performance and significant milestones. The company reported total revenue of $67.3 million, marking a 54% year-over-year (YoY) growth in U.S. net product sales, which reached $29 million. This strong performance was driven by the successful launch of ZEVTERA in the U.S. market and the acceptance of Zoliflodacin's New Drug Application (NDA) by the FDA.

The Q2 results highlight Innoviva's commitment to innovation and expansion in the biopharmaceutical sector. The company's ZEVTERA launch in the U.S. represents a significant step forward in its strategic expansion, positioning Innoviva to capitalize on the growing demand for advanced therapeutic solutions. Additionally, the acceptance of Zoliflodacin's NDA by the FDA sets the stage for potential approvals and commercialization in the future.

Innoviva's financial highlights for Q2 2025 include:
- Total revenue of $67.3 million, up from $43.5 million in Q2 2024, representing a 54% YoY growth.
- U.S. net product sales of $29 million, a 54% YoY increase from $18.8 million in Q2 2024.
- The company's gross margin improved significantly, reaching 35% (non-GAAP) compared to 28% in Q2 2024.

Looking ahead, Innoviva has set a PDUFA date of December 15, 2025, for the review of its Zoliflodacin NDA. This regulatory milestone is crucial for the company, as it could unlock significant revenue opportunities if approved. The company's strong Q2 performance and strategic initiatives position it well to continue its growth trajectory and capitalize on market opportunities.

References:
[1] https://theoutpost.ai/news-story/enovix-reports-strong-q2-2025-results-launches-ai-1-battery-platform-18554/
[2] https://www.business-standard.com/companies/quarterly-results/jindal-stainless-q1fy26-net-profit-up-10-percent-on-higher-sales-125080601580_1.html
[3] https://www.ainvest.com/news/agios-pharmaceuticals-navigating-pyrukynd-thalassemia-pdufa-sickle-cell-pipeline-risks-valuation-pressure-2508/