Theravance Biopharma, Inc. has reported its financial and operational results for the second quarter of 2024, highlighting both challenges and achievements in their ongoing projects. The company recognized a slight decline in net sales for
YUPELRI® (revefenacin), which amounted to $54.5 million, a 1% decrease compared to the same period last year. Despite this, Theravance's CEO Rick Winningham remains optimistic about future growth based on consistent demand.
The collaboration revenue with
Viatris was $14.3 million, reflecting a 4% increase from the second quarter of 2023. Viatris also submitted a New Drug Application (NDA) for YUPELRI in China, potentially earning a $7.5 million milestone for Theravance upon approval. Theravance's ongoing study on
ampreloxetine, a treatment for symptomatic
neurogenic orthostatic hypotension (nOH) in multiple system atrophy (MSA) patients, has seen significant progress, with 80% of study sites now activated. The final patient for the open-label portion of the study is expected around mid-2025, with top-line data anticipated six months later.
TRELEGY, another significant product for Theravance, posted global net sales of $1.065 billion for the second quarter of 2024, boosting the likelihood of achieving up to $50 million in milestone payments for Theravance if certain sales thresholds are met. The company ended the quarter with a cash balance of $96.1 million.
Financially, Theravance reported total revenue of $14.3 million for the second quarter of 2024, entirely from the Viatris collaboration. Research and Development (R&D) expenses rose modestly to $10.0 million, up from $9.4 million in the same period of 2023. Selling, General, and Administrative (SG&A) expenses decreased to $17.1 million from $19.3 million last year.
The second quarter also saw Theravance incurring a $3.0 million non-cash impairment charge due to a softening R&D lab space market in South San Francisco. Share-based compensation expenses were also reduced to $5.4 million compared to $6.3 million in the previous year. As a result, the company's net loss increased slightly to $16.5 million from $15.6 million in the second quarter of 2023.
Looking ahead, Theravance updated its 2024 financial guidance, projecting R&D expenses between $30 million and $36 million and SG&A expenses between $45 million and $55 million, excluding share-based compensation. The company also expects share-based compensation expenses to be between $18 million and $22 million for the full year.
Theravance is actively exploring ways to unlock additional value from its substantial Irish tax assets, with plans to engage with tax and financial advisors. The goal is to bridge the gap between the company's share price and the intrinsic value of its diverse portfolio, including YUPELRI, ampreloxetine, TRELEGY, and other assets.
Theravance's intellectual property portfolio also saw an addition with a new method of use patent for YUPELRI, granted on July 30, 2024, and expiring in August 2039. This patent is listed in the FDA Orange Book. Moreover, Theravance has settled patent litigation with four generic drug companies, granting them licenses to market generic versions of YUPELRI in the U.S. starting April 23, 2039.
Overall, Theravance Biopharma continues to focus on delivering impactful medicines and driving shareholder value, despite facing near-term challenges in some of its financial metrics. The company remains committed to advancing its clinical programs and achieving key milestones in the upcoming quarters.
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