Theravance Biopharma Inc. (NASDAQ:TBPH) is a clinical-stage biopharmaceutical company that has steadily built a reputation for its focus on advancing treatments in areas of high unmet medical need. Originally spun off from Innoviva in 2014, the company was designed to operate independently with a vision to discover, develop, and commercialize transformative therapeutics for serious respiratory and neurological conditions. Headquartered in Dublin, Ireland, with operations in South San Francisco, California, Theravance Biopharma blends the rigor of a science-driven R&D platform with the commercial acumen to monetize its pipeline through strategic collaborations and milestone-generating partnerships.
Theravance first gained traction in the biotech space through its development of YUPELRI® (revefenacin), the first and only once-daily, nebulized long-acting muscarinic antagonist (LAMA) approved in the United States for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Co-commercialized with Viatris, YUPELRI continues to gain market share and institutional adoption, validating Theravance’s ability to bring innovative respiratory solutions to market.
In addition to its commercial asset, the company retains royalty rights to TRELEGY Ellipta, a once-daily single inhaler triple therapy for COPD and asthma marketed globally by GSK. Although Theravance monetized a portion of these royalties to Royalty Pharma in exchange for near-term liquidity, it remains entitled to future milestone payments and significant long-term upside once royalty rights resume in eligible territories starting in 2029.
Theravance Biopharma’s pipeline is headlined by ampreloxetine, a norepinephrine reuptake inhibitor being developed for symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA)—a rare, progressive neurodegenerative disease. With Orphan Drug Designation granted in the U.S., ampreloxetine is currently being evaluated in a Phase 3 randomized withdrawal study (CYPRESS), which is expected to complete enrollment in 2025 and deliver top-line results shortly after.
The company operates with a disciplined financial model, maintaining a debt-free balance sheet and a capital-light structure while advancing its pipeline. Its dual-revenue strategy—anchored by YUPELRI sales and TRELEGY royalties—provides non-dilutive funding to support research and development initiatives. Additionally, Theravance is conducting a strategic review through an independent committee to evaluate options that could unlock further shareholder value, signaling management’s commitment to both innovation and capital efficiency.
With a track record of regulatory success, deep clinical expertise, and a clear focus on underserved markets, Theravance Biopharma is strategically positioned to deliver long-term value to patients and investors alike.
Yupelri Sales Strength Underscores Commercial Viability
One of the pillars of Theravance’s bullish thesis is the consistent growth of its FDA-approved product YUPELRI® (revefenacin)—the first and only once-daily, nebulized LAMA bronchodilator indicated for chronic obstructive pulmonary disease (COPD). Q1 2025 marked another strong quarter, with Viatris—its commercial partner—reporting $58.3 million in net U.S. sales, representing a 6% year-over-year increase. Notably, hospital channel momentum surged with a 48% increase in doses pulled through compared to Q1 2024. Customer demand also rose 5%, reinforcing YUPELRI’s entrenched value in the COPD treatment landscape.
Importantly, Theravance earns a 35% share of net YUPELRI sales. In Q1 2025, this translated to $20.4 million in implied revenue, again reflecting a 6% YoY increase. The company’s growing cut of these sales validates its ability to extract durable value from commercial partnerships without maintaining a bloated cost structure. Moreover, revenue from Viatris-related collaboration came in at $15.4 million, showing consistent upward trajectory.
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TRELEGY Royalties and Milestone Triggers Add Strategic Upside
In addition to YUPELRI, Theravance continues to benefit from global sales of TRELEGY Ellipta, a triple therapy COPD inhaler marketed by GSK. GSK reported $854 million in Q1 2025 TRELEGY sales—a 14% increase from Q1 2024. While the company sold a portion of its future royalties to Royalty Pharma in a non-dilutive cash-raising transaction, Theravance retains long-term upside.
Two potential near-term milestone payments remain on the table: a $50 million payment triggered by ~$3.41 billion in FY 2025 global net sales and a $100 million milestone at ~$3.51 billion in FY 2026. Analysts project that GSK is on track to reach these thresholds based on current growth rates. Additionally, royalties of up to 8.5% are set to return to Theravance in eligible territories beginning mid-2029—positioning the company for substantial passive revenue in the long run.
Ampreloxetine: A Potential Breakthrough for MSA Patients
Beyond commercial assets, the crown jewel in Theravance’s clinical pipeline is ampreloxetine, a norepinephrine reuptake inhibitor currently being developed for symptomatic nOH in patients with multiple system atrophy (MSA)—a rare, debilitating neurodegenerative disorder.
The ongoing Phase 3 CYPRESS trial (Study 0197) is nearing full enrollment, with final patients expected to be enrolled by late summer 2025. Top-line data is anticipated six months later, potentially by early 2026. This randomized withdrawal study evaluates the durability and efficacy of ampreloxetine following 20 weeks of treatment. Results from previous studies (such as Study 0170) showed that ampreloxetine produced a favorable increase in norepinephrine levels, improved blood pressure control, and led to durable symptom improvements—all without exacerbating supine hypertension, a common side effect in this patient population.
At the 2025 American Academy of Neurology annual meeting, Theravance presented analyses reinforcing ampreloxetine’s positive pharmacodynamic profile. Two abstracts were also accepted at the International MSA Congress in Boston, further validating its scientific credibility. The investigational therapy has already received Orphan Drug Designation, giving it potential for seven years of exclusivity in the U.S. if approved.
With a target market of around 50,000 MSA patients in the U.S.—and 70–90% of these experiencing nOH symptoms—ampreloxetine represents a meaningful opportunity to address a high unmet medical need. No currently approved drugs are designed specifically for nOH in MSA patients, positioning ampreloxetine as a potential first-in-class treatment.
Financial Discipline and Strategic Optionality
Theravance continues to operate with strong financial stewardship. As of March 31, 2025, the company held approximately $131 million in cash, cash equivalents, and marketable securities. Importantly, it carries no debt, which gives it operational flexibility and avoids shareholder dilution. Operating expenses have remained lean and predictable. R&D expenses for the quarter were $11.5 million while SG&A came in at $18.4 million, both within the company’s full-year guidance ranges.
While Theravance posted a Q1 2025 net loss of $13.6 million, the non-GAAP net loss from operations was a much smaller $8.6 million, aligning with its disciplined capital deployment strategy. The company reaffirmed its full-year 2025 guidance, including expected R&D spend of $32–$38 million and SG&A expenses of $50–$60 million, excluding stock-based compensation.
In late 2024, the Board of Directors formed a Strategic Review Committee to assess all alternatives to unlock shareholder value. The review is ongoing, but it signals that the company is actively considering acquisitions, licensing deals, or even M&A to accelerate its growth trajectory.
A Rare Disease Market With High Reward Potential
MSA and nOH represent underpenetrated markets with enormous treatment gaps. Symptomatic nOH is a condition characterized by dangerous blood pressure drops upon standing, often leaving patients unable to remain upright for more than a few seconds. Symptoms like dizziness, fainting, fatigue, and blurred vision significantly reduce quality of life and increase risk of injury. Yet existing therapies are inadequate—many are off-label and do not specifically target MSA patients, where disease progression is aggressive.
The market opportunity for a well-tolerated, once-daily agent like ampreloxetine is substantial. If successful, the drug could become the standard of care in this orphan indication and command pricing power reflective of its clinical benefit and market rarity. Furthermore, the ongoing CYPRESS trial is designed with a rigorous placebo-controlled withdrawal period, increasing the likelihood that regulators will accept the data package for NDA approval.
Conclusion: Theravance Biopharma Offers a Compelling Risk-Reward Profile
Theravance Biopharma is entering a pivotal period defined by clinical catalysts, commercial growth, and strategic flexibility. With YUPELRI sales scaling, TRELEGY milestones in sight, and a late-stage pipeline asset potentially unlocking a multi-hundred-million-dollar market, the company is quietly building a case as one of biotech’s most undervalued growth plays.
Its strong cash position, zero debt, and contained cash burn make it a low-risk bet relative to many development-stage peers. As the CYPRESS trial nears full enrollment and Wall Street watches for early signals of efficacy in ampreloxetine, the stock could rapidly re-rate. Analysts have already begun to take notice, with BTIG, HC Wainwright, and others issuing Buy ratings and price targets ranging from $15 to $25—implying 35% to over 120% upside from current levels.
With a lean structure, late-stage optionality, and revenue streams already in place, Theravance Biopharma is well-positioned for a breakout 2025 and beyond.
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