8-K: Theravance Biopharma Reports Record Q4 and Full Year 2024 Financial Results, Driven by YUPELRI and TRELEGY

Theravance Biopharma announces strong financial results for Q4 and full year 2024, highlighted by record YUPELRI sales and progress in the CYPRESS study for Ampreloxetine.

Summary

• Theravance Biopharma reported record fourth quarter and full year 2024 financial results.
• YUPELRI US net sales reached an all-time high of $66.7 million in Q4 2024 and $238.6 million for the full year, representing increases of 10% and 8% respectively, compared to 2023.
• TRELEGY net sales, as reported by GSK, reached $3.46 billion in FY 2024, up 26% compared to 2023, triggering a $50 million milestone payment to Theravance Biopharma.
• The CYPRESS study for Ampreloxetine is on track to enroll the final patient in the open label portion by mid-2025.
• The company ended Q4 2024 with $88 million in cash, excluding the $50 million TRELEGY milestone payment received in February 2025.
• Total revenue for the fourth quarter of 2024 was $18.8 million, consisting entirely of Viatris collaboration revenue.
• Net loss was $15.5 million in the fourth quarter of 2024, compared to $8.5 million in the same period in 2023.
• The company expects minimal levels of Non-GAAP Losses from Operations and Cash Burn in 2025, similar to levels incurred in 2024.

Sentiment

Score: 7

Explanation: The document presents a generally positive outlook, driven by strong sales of YUPELRI and TRELEGY, and progress in the CYPRESS study. However, the reported net loss and ongoing strategic review introduce some uncertainty.

Positives

• YUPELRI sales are growing, with potential for further milestones.
• TRELEGY sales are strong, generating milestone payments and future royalties.
• The CYPRESS study is progressing as planned.
• The company has a solid cash position.
• Operating expenses are managed within guidance.
• There is potential for significant financial returns from YUPELRI growth in the US and China.

Negatives

• The company reported a net loss of $15.5 million in Q4 2024.
• Non-GAAP net loss was $2.5 million in the fourth quarter 2024 compared to a non-GAAP net income of $1.4 million in the same period in 2023.

Risks

• The company's future performance is subject to risks and uncertainties, including those related to clinical studies, regulatory approvals, and collaborations with third parties.
• The Strategic Review Committee is evaluating strategic alternatives, which introduces uncertainty.
• Milestone thresholds may not be achieved.
• Clinical studies may not yield favorable results.
• Regulatory authorities may make unfavorable decisions.

Future Outlook

The company expects to continue growing YUPELRI sales, progress the CYPRESS study for Ampreloxetine, and potentially receive additional milestone payments for both YUPELRI and TRELEGY. They anticipate minimal Non-GAAP Losses from Operations and Cash Burn in 2025.

Management Comments

• Theravance Biopharma ended 2024 on a high note, having collaborated closely with Viatris to deliver record fourth quarter YUPELRI net sales and profitability, while achieving $50 million in TRELEGY related sales milestones, said Rick E Winningham, Theravance Biopharma CEO.
• Our hospital-based commercial organization executed particularly well through the end of the year, positioning us to continue driving YUPELRI growth in 2025 and beyond.
• These achievements, coupled with steady progress towards enrolling the last patient in the open label portion of our pivotal CYPRESS Study by mid-2025 and additional potential YUPELRI and TRELEGY milestones in the coming 12-24 months, highlight the multiple components of value created by our ongoing strategy.

Industry Context

Theravance Biopharma operates in the respiratory and neurological therapeutic areas. The company's focus on YUPELRI for COPD and Ampreloxetine for nOH in MSA addresses unmet needs in these markets. The success of TRELEGY, commercialized by GSK, contributes significantly to Theravance Biopharma's financial performance through milestone payments and future royalties.

Comparison to Industry Standards

• YUPELRI competes with other LAMAs in the COPD market, such as Spiriva (Boehringer Ingelheim) and Incruse Ellipta (GSK).
• The $238.6 million in sales is a good result but still significantly lower than Spiriva which had sales of over $3 billion at its peak.
• TRELEGY competes with other triple therapies for COPD and asthma, such as Symbicort (AstraZeneca) and Advair (GSK).
• The $3.46 billion in sales is a good result and shows that TRELEGY is a leading product in its class.
• Ampreloxetine, if approved, would compete with other treatments for nOH, such as midodrine and droxidopa.
• These treatments have limited efficacy and significant side effects, so there is a significant unmet need for new treatments.

Stakeholder Impact

• Shareholders: Potential for increased value through product growth and strategic initiatives.
• Employees: Continued employment and potential for career growth.
• Patients: Access to new and improved therapies.
• Viatris: Continued collaboration on YUPELRI commercialization.
• GSK: Continued royalties from TRELEGY sales.

Next Steps

• Complete enrollment in the CYPRESS study.
• Prepare for NDA filing for Ampreloxetine.
• Continue to grow YUPELRI sales in the US and China.
• Pursue potential TRELEGY milestones.
• Strategic Review Committee to continue to evaluate a range of alternatives with the objective of unlocking shareholder value.

Key Dates