Earnings summaries and quarterly performance for Theravance Biopharma.
Executive leadership at Theravance Biopharma.
Rick Winningham
Chief Executive Officer
Aine Miller
Senior Vice President, Development and Head of Ireland Office
Aziz Sawaf
Senior Vice President, Chief Financial Officer
Brett Grimaud
Senior Vice President, General Counsel and Secretary
Rhonda Farnum
Chief Business Officer and Senior Vice President, Commercial & Medical Affairs
Board of directors at Theravance Biopharma.
Research analysts who have asked questions during Theravance Biopharma earnings calls.
Douglas Tsao
H.C. Wainwright & Co.
3 questions for TBPH
David Risinger
Leerink Partners
2 questions for TBPH
Alexander Kelly
TD Cowen
1 question for TBPH
Debanjana Chatterjee
JonesTrading Institutional Services
1 question for TBPH
Ellen Horste
TD Cowen
1 question for TBPH
Ernesto Rodriguez-Dumont
TD Cowen
1 question for TBPH
Marc Frahm
TD Cowen
1 question for TBPH
Recent press releases and 8-K filings for TBPH.
- Ampreloxetine, a highly selective norepinephrine transporter inhibitor, is being developed by Theravance Biopharma for neurogenic orthostatic hypotension (NOH) in Multiple System Atrophy (MSA) patients, a condition affecting approximately 40,000 patients in the U.S. with significant unmet medical need.
- The pivotal Phase 3 CYPRESS study, designed based on compelling results from a pre-specified analysis in MSA subjects from the previous Redwood study, has completed open-label enrollment and is expected to have top-line data readout in Q1 2026.
- If CYPRESS results are positive, Theravance Biopharma plans for an expedited NDA submission and priority review, anticipating a premium value opportunity consistent with rare disease pricing, as Ampreloxetine could be the first durable, disease-specific therapy for NOH in MSA.
- Theravance Biopharma (TBPH) is nearing completion of its pivotal Phase 3 CYPRESS study for Ampraloxetine, a potential treatment for neurogenic orthostatic hypotension (NOH) in patients with multiple system atrophy (MSA), with top-line data anticipated in Q1 2026.
- The company is in a strong financial position, reporting $333 million in cash and no debt at the end of the last quarter, and achieved cash flow break-even in Q3.
- Ampraloxetine targets an orphan neurology population of approximately 40,000 U.S. patients with NOH due to MSA, representing a significant unmet medical need with no approved durable disease-specific therapy.
- The commercial strategy focuses on a lean model targeting specialized centers, with pricing expectations consistent with rare neurology, potentially averaging $300,000 per patient per year.
- Theravance Biopharma is developing ampreloxetine, an orphan drug designated to treat neurogenic orthostatic hypotension (NOH) in patients with multiple system atrophy (MSA).
- The pivotal Phase III Cypress study for ampreloxetine is finishing, with top-line data expected in the first quarter of 2026.
- There is a significant unmet medical need for NOH in MSA, with an estimated 40,000 patients in the U.S. and no approved durable disease-specific therapy currently available.
- Theravance Biopharma ended the last quarter with $333 million in cash, no debt, and achieved cash flow break-even in the third quarter, with an additional $175 million in high-probability near-term milestones expected over the next 14 months.
- The company anticipates rare disease pricing for ampreloxetine, aligning with established precedents in rare neurology, given its potential to be the first and only durable therapy for NOH in MSA.
- TBPH maintains a strong financial position with ~$333 million in cash and no debt, supported by cash-generating YUPELRI sales and $175 million in near-term, high-probability sales-based milestones.
- The company has completed Phase 3 CYPRESS enrollment in Q3 2025 for Ampreloxetine, a novel treatment for neurogenic orthostatic hypotension (nOH) in Multiple System Atrophy (MSA), with topline data anticipated in Q1 2026.
- Ampreloxetine targets approximately 40,000 underserved patients in the U.S. with symptomatic nOH due to MSA, with additional significant market opportunities in Europe and Asia.
- Previous Phase 3 subgroup analysis indicated Ampreloxetine could improve the ability to maintain an upright posture, lessen functional burden, and improve quality of life in MSA patients, with no worsening of supine hypertension observed.
- If approved, Ampreloxetine has the potential to be the first tailored treatment for nOH in MSA, offering a once-daily dosing regimen and addressing a high unmet need in a concentrated rare neurology market.
- Theravance Biopharma, Inc. is hosting a virtual key opinion leader (KOL) investor event on December 8, 2025, to discuss Ampreloxetine, a potential precision medicine therapy for Neurogenic Orthostatic Hypotension (nOH) in Multiple System Atrophy (MSA).
- The Phase 3 CYPRESS trial for Ampreloxetine completed enrollment in Q3 2025, with topline data anticipated in Q1 2026. If positive, the company plans an expedited NDA submission for this drug, which has FDA Orphan Drug Designation and targets approximately 40,000 underserved patients in the U.S..
- The company reported a strong financial position with a cash balance of $332.7 million as of September 30, 2025, and achieved breakeven in Q3 2025.
- The 2026 Annual General Meeting of Shareholders is scheduled for June 12, 2026, in Dublin, Ireland.
- Theravance Biopharma has a strong financial foundation with no debt, $330 million in cash, and an additional $175 million in near-term milestones expected over the next 15 months.
- The company's product, Yupelri, generates approximately $50 million annually in operating cash and is experiencing growth rates and margin expansion through improved channel mix and fulfillment optimization.
- A significant catalyst is the Phase 3 Cypress study readout for ampraloxetine, a treatment for neurogenic orthostatic hypotension (nOH) in Multiple System Atrophy (MSA) patients, anticipated in Q1 2026.
- Ampraloxetine targets a rare neurological condition affecting 40,000 patients in the United States and is differentiated by not increasing supine hypertension, a key advantage over existing treatments.
- Theravance Biopharma has significantly evolved, eliminating debt, reducing its burn rate, and establishing a strong financial foundation with $330 million in cash and an additional $175 million in near-term, near-certain milestones expected over the next 15 months.
- The company anticipates the readout of its Phase 3 Cypress study for ampraloxetine, targeting neurogenic orthostatic hypotension (nOH) in Multiple System Atrophy (MSA) patients, in Q1 next year (2026).
- Ampraloxetine previously demonstrated a 1.6-point change in the OHSA composite score in the Redwood study's MSA subgroup, exceeding the clinically meaningful threshold of a one-point change, and the Cypress study is designed to achieve a one-point or greater change.
- Yupelri contributes approximately $50 million annually in operating cash, with ongoing efforts focused on improving hospital-to-home patient persistence and optimizing channel mix, which are currently in the "middle innings" of development.
- Most of the New Drug Application (NDA) work for ampraloxetine is already complete, allowing for a relatively quick filing following positive Cypress data, and the drug has not shown an increase in supine hypertension, a key advantage over existing treatments.
- Theravance Biopharma reported a strong financial position with approximately $333 million in cash and no debt as of September 30, 2025, achieving breakeven in Q3 2025.
- The company anticipates $175 million in near-term, high-probability milestones, comprising $150 million from TRELEGY and $25 million from YUPELRI.
- The Phase 3 CYPRESS trial for Ampreloxetine completed enrollment in Q3 2025, with topline data expected in Q1 2026, representing a significant near-term catalyst.
- YUPELRI demonstrated strong performance with $71.4 million in U.S. net sales in Q3 2025, a 15% increase compared to Q3 2024, contributing to cash flow with a 35% U.S. profit share and IP protection until 2039.
- For Q3 2025, the company reported a GAAP Net Income of $3.6 million.
- Theravance Biopharma achieved non-GAAP break-even in Q3 2025 and ended the quarter with approximately $333 million in cash and no debt.
- UPELRI net sales for Q3 2025 increased 15% year-over-year to $71.4 million, driven by strong demand and favorable net pricing, leading to record brand profitability.
- The company is on track to achieve $75 million in near-term milestones in Q4 2025, comprising $50 million for Trelegy and $25 million for UPELRI, with cash expected in Q1 2026.
- Top-line results from the pivotal phase III Cypress study of ampraloxetine are anticipated in Q1 2026, representing a potential transformational milestone for the company.
- Theravance Biopharma reported Q3 2025 YUPELRI net sales of $71.4 million, a 15% year-over-year increase, and is on track to trigger a $25 million milestone for achieving $250 million in net sales.
- The company achieved non-GAAP net income of $2.26 million in Q3 2025, reaching non-GAAP breakeven for the quarter, with similar levels expected in Q4 2025.
- Theravance Biopharma ended Q3 2025 with a strong financial position, holding $332.7 million in cash and no debt.
- Topline results for the pivotal Phase 3 CYPRESS study of Ampreloxetine are anticipated in Q1 2026, following the completion of enrollment in August 2025.
- TRELEGY ELLIPTA recorded Q3 net sales of ~$1.0 billion and YTD net sales of ~$2.9 billion, positioning the company to trigger a $50 million milestone in 2025.
Quarterly earnings call transcripts for Theravance Biopharma.
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