8-K: Theravance Biopharma Reports Q1 2025 Financial Results and Provides Corporate Update

Theravance Biopharma reports a 6% increase in YUPELRI net sales and progress in ampreloxetine clinical trials in its first quarter 2025 results.

Summary

• Theravance Biopharma reported its first quarter 2025 financial and operational results.
• YUPELRI net sales, recognized by Viatris, increased by 6% to $58.3 million compared to Q1 2024.
• TRELEGY net sales, as reported by GSK, increased by 14% to $854 million compared to Q1 2024.
• The CYPRESS study for ampreloxetine is nearing completion of open label enrollment, with final patient enrollment expected by late summer and top-line data anticipated approximately 6 months later.
• The company's quarter-end cash balance was $131 million, with no debt.
• Total revenue for the first quarter of 2025 was $15.4 million, consisting entirely of Viatris collaboration revenue, which increased by 6% compared to the same period in 2024.
• Research and Development (R&D) expenses for the first quarter of 2025 were $11.5 million, compared to $9.0 million in the same period in 2024.
• Selling, General and Administrative (SG&A) expenses for the first quarter of 2025 were $18.4 million, compared to $16.7 million in the same period in 2024.
• Net loss was $13.6 million in the first quarter of 2025 compared to $11.7 million in the same period in 2024.
• Non-GAAP net loss from operations was $8.6 million in the first quarter 2025 compared to a non-GAAP net loss from operations of $4.5 million in the same period in 2024.
• The company reaffirms its full year 2025 financial guidance, expecting R&D expenses of $32 million to $38 million and SG&A expenses of $50 million to $60 million, excluding share-based compensation.
• Full year share-based compensation expenses are expected to be $18 million to $20 million.
• Non-GAAP losses from operations and cash burn in 2025 are expected to be similar to levels incurred in 2024.

Sentiment

Score: 6

Explanation: The sentiment is neutral to slightly positive. While sales of key products are growing, the company's net loss has increased. The progress of ampreloxetine's clinical trials is a positive sign for future growth.

Positives

• YUPELRI sales are growing, with a 6% increase in net sales and a 5% increase in customer demand year-over-year.
• Hospital performance for YUPELRI is strong, with a 48% increase in doses year-over-year.
• TRELEGY sales are also growing, with a 14% increase in global net sales year-over-year.
• The CYPRESS study for ampreloxetine is progressing, with open label enrollment nearing completion.
• The company has a strong cash position with $131 million and no debt.
• Theravance Biopharma is eligible for potential milestone payments from TRELEGY sales.
• Royalties from TRELEGY sales will return to Theravance Biopharma in 2029, providing a significant source of value.

Negatives

• Net loss increased to $13.6 million in Q1 2025 from $11.7 million in Q1 2024.
• Non-GAAP net loss from operations increased to $8.6 million in Q1 2025 from $4.5 million in Q1 2024.
• R&D and SG&A expenses increased in Q1 2025 compared to Q1 2024.

Risks

• Delays or difficulties in commencing, enrolling or completing clinical studies could impact the company's pipeline.
• Unfavorable decisions from regulatory authorities could impact the approval of product candidates.
• Dependence on third parties to conduct clinical studies and commercialize products poses a risk.
• The company's ability to protect and enforce its intellectual property rights is crucial.
• Volatility and fluctuations in the trading price and volume of the company's shares could affect investors.
• General economic and market conditions could impact the company's performance.

Future Outlook

The company expects 2025 Non-GAAP Losses from Operations and Cash Burn to be similar to levels incurred in 2024 and reaffirms its full year 2025 financial guidance.

Management Comments

• As we begin the year, we remain focused on delivering against our operational priorities for YUPELRI and ampreloxetine, said Rick E Winningham, CEO of Theravance Biopharma.
• Our commercial partnership with Viatris delivered solid YUPELRI sales growth, aided by a strong performance in the hospital setting.
• TRELEGY delivered another excellent quarter and our clinical team advanced CYPRESS enrollment, which is now nearing completion.
• Our interactions with the MSA community continue to highlight the urgent need for new treatments for symptomatic nOH and ampreloxetines potentially significant value to patients, caregivers and providers, underpinning our motivation to complete CYPRESS enrollment and share our results.

Industry Context

The report highlights the continued growth in the COPD and MSA treatment markets, with YUPELRI and TRELEGY showing strong sales growth. The progress of ampreloxetine in clinical trials addresses an unmet need for symptomatic nOH in MSA patients.

Comparison to Industry Standards

• TRELEGY's performance can be compared to other triple therapy inhalers like GlaxoSmithKline's Breo Ellipta and AstraZeneca's Symbicort, assessing market share and growth rates.
• YUPELRI's growth in the nebulized LAMA market can be benchmarked against competitors like Perforomist (formoterol fumarate) and Brovana (arformoterol tartrate), focusing on market penetration and adoption rates.
• Ampreloxetine's development for nOH in MSA can be compared to existing treatments like midodrine and droxidopa, evaluating efficacy, safety, and patient outcomes.

Stakeholder Impact

• Shareholders: The company is committed to creating/driving shareholder value.
• Patients: Ampreloxetine has the potential to be a first in class therapy effective in treating a constellation of cardinal symptoms in MSA patients.
• Employees: Continued important clinical, regulatory and pre launch preparations across the organization.

Next Steps

• Complete open label enrollment for the CYPRESS study by late summer.
• Anticipate top-line data from the CYPRESS study approximately 6 months after the last patient is enrolled.
• Continue NDA preparations for ampreloxetine and plan to request Priority Review.
• Continue to evaluate a range of strategic alternatives with the objective of unlocking shareholder value.

Key Dates

Keywords

Theravance Biopharma, YUPELRI, Ampreloxetine, TRELEGY, Financial Results, COPD, MSA, nOH, Clinical Trials, Viatris, GSK