Theravance Biopharma, Inc. (NASDAQ:TBPH) is a biopharmaceutical company primarily focused on the development and commercialization of medicines. The company's key priorities include driving growth for its approved product YUPELRI, advancing its late-stage investigational asset ampreloxetine, and maximizing the value of its economic interests.

Financials

In the first quarter of 2024, Theravance Biopharma reported revenue of $14.5 million, a 39% increase compared to the prior year period. This growth was driven by increased YUPELRI net sales and improved operating margins for the product. For the full year 2023, the company reported revenue of $57.4 million and a net loss of $55.2 million. Operating cash flow for 2023 was negative $27.0 million, while free cash flow was negative $29.5 million.

YUPELRI (revefenacin) Inhalation Solution: Driving Consistent Growth

YUPELRI, a once-daily, nebulized long-acting muscarinic antagonist (LAMA) approved for the maintenance treatment of COPD, continues to be a key driver of Theravance Biopharma's business. In the first quarter of 2024, YUPELRI net sales reached $55.2 million, representing 18% year-over-year growth. The company's implied 35% share of these net sales was $19.3 million, up 18% compared to the prior year period.

Theravance Biopharma's commercial strategy for YUPELRI is focused on increasing penetration in both the hospital and community settings. In the first quarter, the company's hospital team delivered another record-high quarter, with hospital doses shipped increasing 31% year-over-year. This strong hospital performance has translated to the community setting, where YUPELRI maintained approximately 31% market share.

Looking ahead, the company remains optimistic about YUPELRI's continued growth potential. Theravance Biopharma is eligible to receive a $25 million sales milestone from its partner Viatris once YUPELRI net sales reach $250 million in a calendar year. Additionally, the company expects Viatris to file for regulatory approval of YUPELRI in China by mid-2024, which could unlock further upside through low double-digit tiered royalties on net sales.

Ampreloxetine: Advancing Towards Potential Approval for Symptomatic nOH in MSA

Theravance Biopharma's late-stage investigational asset, ampreloxetine, is being developed for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA). The company is currently enrolling patients in the registrational Phase 3 CYPRESS study, with the expectation of completing enrollment of the open-label portion in the second half of 2024.

Ampreloxetine has the potential to be the first safe, convenient, and durably effective treatment option for MSA patients with symptomatic nOH, a significant unmet medical need. The company is preparing for a potential NDA filing shortly after the completion of the CYPRESS study, and is working to position ampreloxetine for broad availability should the study be successful.

Theravance Biopharma will be hosting a virtual investor event on May 23, 2024 to provide an in-depth overview of the ampreloxetine program and the opportunity in MSA with symptomatic nOH. The event will feature presentations from key opinion leaders in the field of autonomic dysfunction.

Economic Interests: Potential for Significant Milestone Payments from TRELEGY

In addition to its internal development programs, Theravance Biopharma maintains economic interests in several partnered assets, including TRELEGY ELLIPTA. TRELEGY, a once-daily single inhaler triple therapy for COPD and asthma, is commercialized by GlaxoSmithKline (GSK).

Theravance Biopharma is eligible to receive up to $200 million in potential milestone payments from Royalty Pharma based on TRELEGY's global net sales performance. In the first quarter of 2024, TRELEGY net sales reached $749 million, representing 32% year-over-year growth. This strong performance increases the likelihood that Theravance Biopharma will achieve at least one of the $25 million milestones in 2024, with the potential for additional milestones in 2025 and 2026.

Financials

Theravance Biopharma ended the first quarter of 2024 with approximately $100 million in cash, cash equivalents, and marketable securities, and no debt. The company is reiterating its previous financial guidance, which includes an expectation of approaching non-GAAP breakeven in the second half of 2024.

This financial position, combined with the potential for milestone payments from TRELEGY and the anticipated launch of ampreloxetine, if approved, positions Theravance Biopharma well to execute on its strategic priorities and deliver long-term value for shareholders.

Risks and Challenges

While Theravance Biopharma has made significant progress, the company faces several risks, including the potential for generic competition to YUPELRI, the success of the ampreloxetine CYPRESS study, and the ability of its partners to effectively commercialize its products. Additionally, the company's financial performance is subject to fluctuations in revenue and expenses.

Conclusion

Overall, Theravance Biopharma appears well-positioned to capitalize on the growth opportunities for YUPELRI, advance ampreloxetine towards potential approval, and benefit from its economic interests. The company's focus on execution and disciplined capital allocation should enable it to deliver long-term value for shareholders.