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Introduction & Market Context
Theravance Biopharma (NASDAQ:TBPH) presented its first quarter 2025 financial results on May 8, highlighting revenue growth driven by its key products while facing increased expenses from pipeline development. The company’s stock closed at $9.99 but experienced a slight decline of 0.9% in aftermarket trading following the earnings release, reflecting investor concerns over the earnings per share miss despite revenue exceeding expectations.
The biopharmaceutical company continues to focus on its two revenue-generating assets, YUPELRI and TRELEGY, while advancing its pipeline candidate ampreloxetine through late-stage clinical development. With a strong cash position and no debt, Theravance maintains financial flexibility as it pursues growth opportunities.
Quarterly Performance Highlights
Theravance reported Q1 2025 revenue of $15.4 million, representing a 6% increase year-over-year and slightly exceeding analyst expectations of $15.14 million. However, the company posted a GAAP net loss of $13.6 million, compared to $11.7 million in Q1 2024, with earnings per share of -$0.27 missing the forecast of -$0.22.
The company’s key commercial product YUPELRI (revefenacin), the only once-daily nebulized LAMA maintenance treatment for COPD, continued to demonstrate strong growth. Q1 2025 net sales reached $58.3 million, increasing 6% year-over-year, while hospital doses grew impressively by 48% compared to Q1 2024.
As shown in the following chart of YUPELRI’s net sales growth:
Hospital adoption of YUPELRI has shown particularly strong momentum, as illustrated in this quarterly dose chart:
TRELEGY, GSK’s triple therapy for COPD and asthma for which Theravance receives milestone payments and future royalties, also performed well with Q1 2025 net sales of $854 million, up 14% year-over-year. This growth trajectory puts TRELEGY on pace to trigger significant milestone payments for Theravance.
The following chart details the potential TRELEGY sales milestones and illustrates the strong global net sales growth:
Detailed Financial Analysis
Theravance’s Q1 2025 financial results revealed a mixed picture. While revenue increased, operating expenses also rose significantly, contributing to the wider net loss compared to the previous year. Research and development expenses increased to $11.5 million from $9.0 million in Q1 2024, primarily due to higher CYPRESS trial enrollment and regulatory activities for ampreloxetine. Selling, general, and administrative expenses rose to $18.4 million from $16.7 million, driven by commercial and medical affairs initiatives.
The company’s detailed financial results are presented in the following table:
A summary of the Q1 2025 financial highlights compared to Q1 2024 shows the key metrics:
Despite the wider loss, Theravance maintained a strong cash position of $130.9 million at quarter end with no debt, bolstered by a $50 million TRELEGY milestone payment received in February 2025. This provides the company with financial flexibility to fund ongoing operations and development programs.
Strategic Initiatives & Pipeline Updates
Theravance’s strategic focus remains on maximizing the value of YUPELRI while advancing ampreloxetine through clinical development. The company highlighted that YUPELRI has significant growth potential, with less than 5% penetration of its addressable market and IP protection until 2039 in the US. Additionally, a New Drug Application for YUPELRI was submitted in China in June 2024, which could trigger a $7.5 million milestone payment upon approval and generate 14-20% tiered royalties.
For ampreloxetine, Theravance’s once-daily selective norepinephrine reuptake inhibitor in development for symptomatic neurogenic orthostatic hypotension (nOH) in multiple system atrophy (MSA), the CYPRESS study is approaching completion of open-label enrollment. The company expects the last patient to be enrolled by late summer, with top-line data anticipated approximately six months later.
The CYPRESS study design is illustrated in the following diagram:
Theravance has also made progress on the scientific and regulatory fronts, with presentations at major medical conferences and ongoing NDA preparations to facilitate expedited filing following the CYPRESS readout.
Forward-Looking Statements
Looking ahead, Theravance provided financial guidance for 2025, projecting R&D expenses (excluding share-based compensation) of $32-38 million and SG&A expenses of $50-60 million. The company expects non-GAAP loss and cash burn to be similar to 2024 levels, excluding potential milestone payments from TRELEGY and YUPELRI.
The company’s financial guidance metrics are detailed in the following chart:
Theravance highlighted several potential value drivers, including up to $150 million in additional TRELEGY milestones through 2026, with royalties returning from 2029 through the mid-2030s. For YUPELRI, a $25 million milestone would be triggered when annual US net sales reach $250 million, requiring only 5% growth from 2024 levels.
The company’s strong cash generation potential and upside opportunities are summarized in this comprehensive overview:
Despite the wider Q1 loss, Theravance’s management remains confident in the company’s long-term prospects, emphasizing its commitment to returning excess capital to shareholders while maintaining investment in growth opportunities. The company’s focus on YUPELRI expansion, TRELEGY milestone achievement, and ampreloxetine development positions it for potential growth, though investors will be closely monitoring expense management and clinical trial outcomes in the coming quarters.
Full presentation:
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