Innoviva Announces Q3 2024 Financial Results and Company Progress

Innoviva, Inc., a diversified holding company with a core royalties portfolio and a leading platform in critical care and infectious disease known as Innoviva Specialty Therapeutics (IST), recently announced its financial outcomes for the third quarter ending September 30, 2024, along with key corporate achievements.

The company reported robust revenue growth for the third quarter, driven by strong performance from its core GSK royalty assets and increased sales from its IST commercial products, namely GIAPREZA®, XACDURO®, and XERAVA®. Pavel Raifeld, CEO of Innoviva, highlighted that the formation of IST, now in its second year, has led to consistent sales expansion in commercial products, largely due to growing product demand. This development validates Innoviva's investment in hospital-based therapeutics.

One significant highlight was the nomination of XACDURO® for the Best Biotechnology Product by The Galien Foundation USA, recognizing its pioneering science and positive impact on patients. Raifeld expressed pride in this recognition, which underscores their commitment and innovation in addressing significant unmet medical needs. The company is also advancing its pipeline, with plans to submit a New Drug Application (NDA) for zoliflodacin to the U.S. FDA in early 2025. Zoliflodacin is a potential first-in-class, single-dose oral treatment for uncomplicated gonorrhea.

During the past quarter, Innoviva has seen operational progress across its strategic healthcare assets, focusing on prudent capital allocation to maximize shareholder value and identifying multiple opportunities for continued value creation.

Financial highlights for the third quarter of 2024 include:

- Gross royalty revenue from Glaxo Group Limited ("GSK") was $60.5 million, an increase from $57.0 million in the third quarter of 2023.
- Net product sales totaled $27.8 million, with U.S. net product sales at $19.7 million and ex-U.S. sales at $8.1 million. U.S. sales included $13.1 million from GIAPREZA®, $2.3 million from XERAVA®, and $4.3 million from XACDURO®, a 68% rise compared to the third quarter of 2023.
- License revenue amounted to $4.6 million, reflecting product development cost-sharing reimbursements from a partner.
- There was an unfavorable net change of $35.2 million in the fair value of equity and long-term investments, primarily due to a lower share price of Armata Pharmaceuticals.
- Net income stood at $1.2 million, or $0.02 per share, compared to $82.0 million, or $1.26 per share, in the same period last year.
- Cash and cash equivalents totaled $260.6 million, with royalty and product sale receivables amounting to $91.1 million as of September 30, 2024.

Key business and R&D highlights include:

- XACDURO® (sulbactam for injection; durlobactam for injection) for intravenous use, a targeted antibacterial treatment for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. XACDURO® was nominated for the 2024 Prix Galien USA Award for Best Biotechnology Product.
- Zoliflodacin, a potential first-in-class, single-dose oral antibiotic developed in partnership with The Global Antibiotic Research & Development Partnership ("GARDP") for treating uncomplicated gonorrhea. In September 2024, additional findings were presented at the 2024 Sexually Transmitted Infections Prevention Conference in Atlanta, showcasing potent in vitro activity and comparable microbiological cure rates in specific subgroups.
- In October 2024, Innoviva had five presentations at IDWeek 2024 in Los Angeles. These included presentations on zoliflodacin's clinical development and the activity of sulbactam-durlobactam and standard-of-care antibiotics against Acinetobacter baumannii-calcoaceticus complex for hospitalized patients. Three posters, including two on zoliflodacin and surveillance data of eravacycline against clinical pathogens collected worldwide, were also presented.

Innoviva is progressing with zoliflodacin following successful Phase 3 trial results and intends to submit an NDA to the U.S. FDA in early 2025.