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Theravance Biopharma Faces Strategic Shift

Theravance Biopharma recently released its 10-K report. The company is a South San Francisco-based biopharmaceutical firm incorporated in 2013 that develops and commercializes medicines in the United States. Its commercial business centers on YUPELRI, a once-daily nebulized treatment for COPD, while its pipeline includes ampreloxetine, which had been in late-stage development for symptomatic neurogenic orthostatic hypotension in patients with multiple system atrophy. The company also has a collaboration with Viatris for revefenacin, including YUPELRI.

In Item 7, management said the year was defined by a sharp shift in strategy after ampreloxetine’s Phase 3 CYPRESS study failed to meet its primary endpoint on March 3, 2026. Following that result, Theravance said it would wind down the ampreloxetine program and its board’s Strategic Review Committee would accelerate a review of alternatives, including a possible sale of the company. The company also said it is implementing a restructuring to streamline costs, wind down R&D, and significantly reduce G&A, with expected operating expense reductions of about 60% versus 2025 operating expenses of $111.1 million and annual run-rate savings of about $70 million beginning in the third quarter of 2026.

YUPELRI remained the company’s main operating asset. Total YUPELRI net sales increased 12% to $266.6 million in 2025 from $238.6 million in 2024, and customer demand rose 7%. Theravance said it received a $25.0 million milestone payment in January 2026 tied to $250.0 million in U.S. net sales in 2025. Under the Viatris collaboration, Theravance recorded $75.0 million of revenue in 2025, up 16% from $64.4 million in 2024, with the increase driven by higher YUPELRI sales and improved net pricing from favorable channel mix.

Theravance also recorded $32.5 million in licensing and milestone revenue in 2025, including $25.0 million tied to the YUPELRI U.S. sales milestone and $7.5 million tied to regulatory approval by China’s National Medical Products Administration. Total revenue rose to $107.5 million in 2025 from $64.4 million in 2024.

Operating expenses were mixed. Research and development expense was essentially flat at $37.4 million in 2025 versus $37.6 million in 2024. Within R&D, employee-related costs rose to $13.7 million from $12.2 million, share-based compensation fell to $4.1 million from $5.1 million, and external-related costs declined to $16.2 million from $17.1 million. The company said the decline in external spending reflected completion of CYPRESS enrollment in August 2025, partly offset by NDA and regulatory work for ampreloxetine.

Selling, general and administrative expense increased to $73.7 million from $69.2 million. Excluding share-based compensation, SG&A was $59.2 million in 2025 versus $52.9 million in 2024. Theravance said the increase was driven by $2.3 million more in G&A, mainly from one-time legal costs, and a $4.1 million increase in selling, marketing and medical affairs tied to pre-launch work on ampreloxetine. Share-based compensation in SG&A fell to $14.4 million from $16.3 million.

The company also reported a $75.1 million net gain on realized contingent milestone and royalty assets in 2025 from the sale of its remaining TRELEGY royalty interest to GSK for $225.0 million. Theravance said that gain reflected the cash proceeds less the carrying value of the royalty assets of $144.2 million and transaction costs of $5.7 million. In 2024, it recorded a $4.5 million non-cash impairment charge on long-lived assets tied to its South San Francisco laboratory space. Following these announcements, the company's shares moved -0.5%, and are now trading at a price of $20.01. Check out the company's full 10-K submission here.

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