YUPELRI Performance and Potential - YUPELRI net sales for Q1 2025 reached $58.3 million, a 6% increase compared to Q1 2024[10, 24] - Hospital doses of YUPELRI increased by 48% in Q1 2025 compared to Q1 2024[10, 20] - Theravance Biopharma receives 35% of US profits from YUPELRI sales due to a co-promotion agreement with Viatris[9, 11, 16, 23, 58] - A $25 million milestone is achievable if US net sales of YUPELRI exceed $250 million, requiring a 5% growth from 2024[24, 57] - Viatris submitted an NDA in China for YUPELRI in June 2024, with a potential $45 million milestone and 14-20% tiered royalties for Theravance Biopharma[24, 57] TRELEGY Milestones and Royalties - 2024 TRELEGY net sales reached $854 million, a 14% year-over-year increase, positioning the company to trigger a $50 million milestone in 2025[10, 27] - Theravance Biopharma could receive up to $150 million in TRELEGY sales milestones in 2025 and 2026[9, 27, 57] - To trigger the first $25 million milestone in 2025, Royalty Pharma needs to receive $260 million or more in royalty payments from GSK, equivalent to $3063 billion in TRELEGY global net sales[9] - Royalties from TRELEGY net sales, ranging from 5.5% to 8.5%, will return to Theravance Biopharma starting July 1, 2029 (ex-US) and January 1, 2031 (US), extending through the mid-2030s[32, 34, 57, 58] Financial Overview - Theravance Biopharma's cash and cash equivalents totaled $130.9 million at the end of Q1 2025, including a $50 million TRELEGY milestone payment received in February 2025, with no debt[10, 50, 57] - Non-GAAP net loss for Q1 2025 was $8.6 million, compared to $4.5 million for Q1 2024[45, 50] - VIATRIS collaboration revenue was $15.4 million in Q1 2025, compared to $14.5 million in Q1 2024[45, 50]

Company Performance - Theravance Biopharma reported a quarterly loss of $0.17 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.11, and compared to a loss of $0.09 per share a year ago, indicating a significant earnings surprise of -54.55% [1] - The company posted revenues of $15.39 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 4.20%, but showing an increase from year-ago revenues of $14.5 million [2] - Over the last four quarters, the company has surpassed consensus EPS estimates just once and topped consensus revenue estimates two times [2] Stock Outlook - Theravance Bio shares have increased by approximately 6.2% since the beginning of the year, contrasting with the S&P 500's decline of -4.3% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.12 on revenues of $17.1 million, and for the current fiscal year, it is $0.08 on revenues of $96.9 million [7] - The estimate revisions trend for Theravance Bio is mixed, resulting in a Zacks Rank 3 (Hold), suggesting that the shares are expected to perform in line with the market in the near future [6] Industry Context - The Medical - Drugs industry, to which Theravance Bio belongs, is currently ranked in the top 26% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Financial Data and Key Metrics Changes - YUPELRI net sales increased by 6% to just over $58 million, driven by increased demand and favorable pricing [2][4] - Collaboration revenue reported at $15.4 million, up 6% year over year, with YUPELRI brand level cash profitability growing faster than collaboration revenue [16][18] - The company ended the quarter with $131 million in cash and no debt, reflecting a strong financial position [18][24] Business Line Data and Key Metrics Changes - Hospital doses of YUPELRI increased by 48% year on year, achieving record high volume with approximately 316,000 units pulled through the hospital channel [2][7] - GSK reported Trelegy global net sales up 14%, positioning the company to achieve a $50 million milestone from Royalty Pharma in 2025 [4][10] Market Data and Key Metrics Changes - Market research indicates significant future potential for YUPELRI, with additional demand growth expected and a sizable remaining addressable patient population [8] - The company anticipates a decline in clinical trial costs in the second half of the year as the Cyprus study nears completion [19] Company Strategy and Development Direction - The company remains focused on advancing the Sypris trial and optimizing patient enrollment and experience [3] - YUPELRI is positioned as a core growth driver, with strategies in place to improve its financial contribution and achieve key economic milestones [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the commercial prospects of ampreloxetine, with ongoing engagement with payers to ensure understanding of the therapy's role [35][38] - The company reaffirmed its financial guidance metrics and does not anticipate material impacts from potential tariff measures [19][21] Other Important Information - The company is on track to achieve a one-time $25 million milestone if YUPELRI sales reach $250 million in the calendar year [24] - The company is preparing for an expedited NDA submission for ampreloxetine, with significant progress on key modules already completed [16][25] Q&A Session Questions and Answers Question: Status update on ampreloxetine manufacturing and IP - The IP for ampreloxetine is currently in Ireland, with manufacturing of the API outside the U.S. in Taiwan, allowing flexibility in supply adjustments [28] Question: Efforts to increase hospital prescriptions turning into filled chronic prescriptions - The company is focused on ensuring patients receive support through fulfillment programs and follow-up care, emphasizing the importance of local partnerships [29][31] Question: Feedback from payers on ampreloxetine - The company has started engaging with payers to educate them on the disease burden and the role of ampreloxetine, with further discussions expected post-top line data [35][36] Question: Update on YUPELRI Paragraph IV filers - The company has settled with five of the eight filers, with three outstanding litigants remaining [39]

Financial Data and Key Metrics Changes - YUPELRI net sales increased by 6% to just over $58 million, driven by demand growth and favorable pricing [2][4] - Collaboration revenue reported at $15.4 million, up 6% year over year, with YUPELRI brand level cash profitability growing faster than collaboration revenue [16][18] - Operating expenses, excluding share-based compensation, increased to $25 million, primarily due to R&D and SG&A expenses [17][18] - The company ended the quarter with $131 million in cash and no debt, reflecting a strong financial position [18][22] Business Line Data and Key Metrics Changes - Hospital doses of YUPELRI increased by 48% year on year, achieving record high volume with approximately 316,000 units pulled through the hospital channel [2][6] - The performance of YUPELRI in the hospital setting is a key strategic differentiator, contributing significantly to overall brand growth [5][6] - TRELEGY reported global net sales of $854 million, up 14% year over year, positioning the company to achieve a $50 million milestone in 2025 [4][10] Market Data and Key Metrics Changes - Market research indicates significant future potential for YUPELRI, with additional demand growth expected [7] - The company is focused on transitioning hospital patients to community maintenance care, which is critical for long-term growth [6][8] Company Strategy and Development Direction - The company aims to deliver high-quality results in the Sypris trial, with a focus on enrolling the right patients and optimizing study factors [3][12] - YUPELRI is positioned as a foundational and highly profitable asset, with plans to achieve a $25 million near-term milestone and extended IP protection through 2039 [8][9] - The company is preparing for an expedited NDA submission for ampreloxetine, with ongoing engagement with the MSA community [12][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving higher-end milestones for TRELEGY, with consensus estimates for 2025 and 2026 increasing by approximately $100 million [10][11] - The company does not anticipate material impacts from potential tariff measures and remains focused on its value drivers [19][21] - Management highlighted the importance of the transition of care for hospital patients to ensure they receive ongoing treatment [28][30] Other Important Information - The company is actively engaging with payers regarding ampreloxetine and its potential role in treating nOH [33][34] - Five out of eight Paragraph IV filers have been settled regarding YUPELRI, with three litigants remaining [38] Q&A Session Summary Question: Status update on ampreloxetine manufacturing and IP - The IP for ampreloxetine is currently in Ireland, with API manufacturing outside the U.S. in Taiwan, allowing flexibility for future adjustments [26] Question: Efforts to increase hospital prescriptions to filled chronic prescriptions - The company is focused on ensuring patients receive support through fulfillment programs and follow-up care after leaving the hospital [27][30] Question: Feedback from payers on ampreloxetine - The company has started engaging with payers to educate them on the disease burden and the potential role of ampreloxetine [33][34] Question: Update on Paragraph IV filers for YUPELRI - Settlements have been reached with five of the eight filers, with three outstanding litigants [38]

[Executive Summary & Operational Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Operational%20Highlights) This section outlines Theravance Biopharma's Q1 2025 financial and operational performance, emphasizing product updates and strategic initiatives [First Quarter 2025 Overview](index=1&type=section&id=First%20Quarter%202025%20Overview) Theravance Biopharma reported Q1 2025 financial and operational results, highlighting YUPELRI sales growth, strong TRELEGY performance, and near completion of CYPRESS study enrollment - CEO Rick E. Winningham stated the company remains focused on achieving operational priorities for **YUPELRI** and **ampreloxetine** at the start of the year[3](index=3&type=chunk) - Commercial collaboration for **YUPELRI** achieved robust sales growth, particularly strong in the hospital setting[3](index=3&type=chunk) - **TRELEGY** again delivered strong performance, with patient enrollment for the **CYPRESS** study nearing completion[3](index=3&type=chunk) [Product & Pipeline Updates](index=1&type=section&id=Product%20%26%20Pipeline%20Updates) This section details YUPELRI sales growth, Ampreloxetine clinical progress including CYPRESS study updates, and TRELEGY's global sales and future milestone payment expectations [YUPELRI (revefenacin)](index=1&type=section&id=YUPELRI%20(revefenacin)) YUPELRI, a once-daily nebulized LAMA, saw Q1 2025 net sales grow 6%, with customer demand up 5% and hospital utilization increasing 48% - **YUPELRI** is the first and only once-daily nebulized LAMA bronchodilator approved in the U.S. for the maintenance treatment of COPD patients[4](index=4&type=chunk) YUPELRI Q1 2025 Sales Data | Metric | Q1 2025 | Change vs. Q1 2024 | Source | | :--- | :--- | :--- | :--- | | YUPELRI Net Sales (Viatris recognized) | $58.3 million USD | +6% | chunk_num: [6] | | Customer Demand Growth | 5% | - | chunk_num: [7] | | Hospital Channel Utilization Growth | 48% | - | chunk_num: [7] | - The company shares **YUPELRI** profits and losses with Viatris at a 65% to 35% ratio[4](index=4&type=chunk) [Ampreloxetine (CYPRESS Study)](index=1&type=section&id=Ampreloxetine%20(CYPRESS%20Study)) Ampreloxetine, for MSA-related nOH, is nearing completion of CYPRESS study enrollment, with topline data expected in approximately six months, following recent data presentations - Open-label enrollment for the **CYPRESS** study is nearing completion, with final patient enrollment expected by late summer and topline data anticipated in approximately six months[6](index=6&type=chunk)[9](index=9&type=chunk) - In April 2025, the company presented **Ampreloxetine** data at the American Academy of Neurology Annual Meeting, highlighting its expected pharmacodynamic blood pressure effects without exacerbating supine hypertension[9](index=9&type=chunk) - Two abstracts on **Ampreloxetine** were accepted by the International MSA Congress, including a 'late-breaking' oral presentation on its benefits in a pre-specified MSA subgroup from Study 0170[9](index=9&type=chunk) [TRELEGY](index=1&type=section&id=TRELEGY) TRELEGY's Q1 2025 global net sales reached $854 million, up 14%, with expected milestone payments of $50 million in FY2025 and $100 million in FY2026, plus future royalties TRELEGY Global Net Sales and Milestone Payments | Metric | Amount | Change vs. Q1 2024 | Trigger Condition | | :--- | :--- | :--- | :--- | | Q1 2025 Global Net Sales | $854 million USD | +14% (vs $749M) | - | | FY 2025 Milestone Payment | $50 million USD | - | Global net sales ~$3.41B (vs 2024 -1%) | | FY 2026 Milestone Payment | $100 million USD | - | Global net sales ~$3.51B (vs 2024 +2%) | | Royalties from Mid-2029 | Up to 8.5% | - | TRELEGY Net Sales | [Financial Performance](index=2&type=section&id=Financial%20Performance) This section details Theravance Biopharma's first-quarter financial results, including revenue, expenses, net loss, cash position, and full-year 2025 financial guidance [First Quarter Financial Results](index=2&type=section&id=First%20Quarter%20Financial%20Results) Theravance Biopharma reported Q1 2025 total revenue of $15.4 million, with increased expenses leading to a $13.6 million net loss and a $131 million cash balance [Revenue](index=2&type=section&id=Revenue) Q1 2025 total revenue reached $15.4 million, entirely from Viatris collaboration, growing 6% year-over-year, with an implied YUPELRI share of $20.4 million Q1 2025 Revenue Overview | Metric | Q1 2025 (million USD) | Q1 2024 (million USD) | Y-o-Y Change | | :--- | :--- | :--- | :--- | | Total Revenue | 15.4 | 14.5 | +6% | | Viatris Collaboration Revenue | 15.4 | 14.5 | +6% | | YUPELRI Implied 35% Net Sales | 20.4 | 19.3 | +6% | [Expenses](index=2&type=section&id=Expenses) Q1 2025 R&D expenses rose to $11.5 million, SG&A to $18.4 million, with total stock-based compensation at $4.9 million Q1 2025 Expenses Overview | Metric | Q1 2025 (million USD) | Q1 2024 (million USD) | Y-o-Y Change | | :--- | :--- | :--- | :--- | | Research & Development Expenses | 11.5 | 9.0 | +27.8% | | Selling, General & Administrative Expenses | 18.4 | 16.7 | +10.2% | | Total Stock-Based Compensation Expense | 4.9 | 5.2 | -5.8% | | - R&D Stock-Based Compensation | 1.1 | 1.5 | -26.7% | | - SG&A Stock-Based Compensation | 3.8 | 3.7 | +2.7% | [Net Loss & Cash Position](index=3&type=section&id=Net%20Loss%20%26%20Cash%20Position) Q1 2025 GAAP net loss expanded to $13.6 million, non-GAAP net loss to $8.6 million, with cash, cash equivalents, and marketable securities totaling $130.9 million Q1 2025 Net Loss and Cash Position | Metric | Q1 2025 (million USD) | Q1 2024 (million USD) | Y-o-Y Change | | :--- | :--- | :--- | :--- | | Net Loss (GAAP) | (13.6) | (11.7) | +16.2% | | Non-GAAP Net Loss | (8.6) | (4.5) | +91.1% | | Period-End Cash, Cash Equivalents & Marketable Securities | 130.9 | - | - | [2025 Financial Guidance](index=3&type=section&id=2025%20Financial%20Guidance) The company reaffirmed FY 2025 guidance, projecting R&D expenses of $32-38 million, SG&A of $50-60 million, and stock-based compensation of $18-20 million, with non-GAAP operating loss and cash burn similar to 2024 Full-Year 2025 Financial Guidance | Metric | Full-Year 2025 Guidance (million USD) | | :--- | :--- | | R&D Expenses (excluding stock-based compensation) | $32 - $38 | | SG&A Expenses (excluding stock-based compensation) | $50 - $60 | | Stock-Based Compensation Expense | $18 - $20 | | Non-GAAP Operating Loss and Cash Burn | Similar to 2024 levels | [Corporate & Strategic Initiatives](index=3&type=section&id=Corporate%20%26%20Strategic%20Initiatives) This section outlines the company's strategic review committee and its ongoing efforts to evaluate alternatives for shareholder value creation [Strategic Review Committee](index=3&type=section&id=Strategic%20Review%20Committee) The Board established a Strategic Review Committee on November 12, 2024, to evaluate alternatives for shareholder value, with the review still ongoing - The Board of Directors established a **Strategic Review Committee** composed of independent directors on November 12, 2024[10](index=10&type=chunk) - The committee's objective is to evaluate all strategic alternatives to unlock shareholder value[10](index=10&type=chunk) - The strategic review is ongoing, and no additional details are available at this time[10](index=10&type=chunk) [Product Information & Disease Background](index=4&type=section&id=Product%20Information%20%26%20Disease%20Background) This section provides detailed information on Ampreloxetine and the CYPRESS study, along with background on Multiple System Atrophy (MSA) and neurogenic orthostatic hypotension (nOH) [About Ampreloxetine & CYPRESS Study](index=4&type=section&id=About%20Ampreloxetine%20%26%20CYPRESS%20Study) Ampreloxetine is an investigational once-daily norepinephrine reuptake inhibitor for MSA-related nOH, showing promising results in prior studies, with the ongoing CYPRESS Phase 3 study evaluating its efficacy and durability - **Ampreloxetine** is an investigational, once-daily norepinephrine reuptake inhibitor for symptomatic nOH in patients with MSA[17](index=17&type=chunk) - In Study 0170, **Ampreloxetine** demonstrated increased norepinephrine levels, improved blood pressure, clinically meaningful and durable symptom improvement, with no signal of exacerbating supine hypertension[17](index=17&type=chunk) - **CYPRESS** (Study 0197) is a registrational Phase 3, multi-center, randomized withdrawal study, with the primary endpoint being the change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score[18](index=18&type=chunk) [About Multiple System Atrophy (MSA) and nOH](index=5&type=section&id=About%20Multiple%20System%20Atrophy%20(MSA)%20and%20nOH) MSA is a progressive brain disorder, with nOH as a common autonomic symptom defined by a significant blood pressure drop upon standing, affecting 70-90% of the 50,000 US MSA patients - **MSA** is a progressive brain disorder that affects movement, balance, and autonomic nervous system functions[20](index=20&type=chunk) - **nOH** is one of the most common autonomic symptoms of MSA, defined as a drop in systolic blood pressure of **≥20 mmHg** or diastolic blood pressure of **≥10 mmHg** within 3 minutes of standing[20](index=20&type=chunk)[21](index=21&type=chunk) - Approximately **50,000 MSA patients** in the U.S., with **70-90%** experiencing nOH symptoms, many remaining symptomatic despite existing therapies[20](index=20&type=chunk) [About Theravance Biopharma](index=5&type=section&id=About%20Theravance%20Biopharma) Theravance Biopharma focuses on life-improving medicines, with FDA-approved YUPELRI for COPD and late-stage Ampreloxetine for MSA-related nOH, committed to shareholder value - Theravance Biopharma focuses on delivering medicines that improve people's lives[22](index=22&type=chunk) - The company has developed **FDA-approved YUPELRI** for the maintenance treatment of COPD[22](index=22&type=chunk) - **Ampreloxetine** is its late-stage investigational drug, poised to be a first-in-class therapy for symptomatic nOH in MSA patients[22](index=22&type=chunk) [Financial Statements](index=8&type=section&id=Financial%20Statements) This section presents the company's condensed consolidated balance sheets, statements of operations, and reconciliation of GAAP to non-GAAP net loss [Condensed Consolidated Balance Sheets](index=8&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets were $343.6 million, with cash, cash equivalents, and marketable securities at $130.9 million, and shareholder equity at $166 million Condensed Consolidated Balance Sheets (Excerpt) | Item | March 31, 2025 (thousand USD) | December 31, 2024 (thousand USD) | | :--- | :--- | :--- | | **Assets** | | | | Cash, Cash Equivalents and Short-Term Marketable Securities | 130,855 | 88,350 | | Collaboration Receivable | 15,353 | 18,440 | | Milestone and Royalty Receivable | - | 50,000 | | Total Assets | 343,582 | 354,161 | | **Liabilities & Stockholders' Equity** | | | | Current Liabilities | 31,502 | 32,085 | | Stockholders' Equity | 165,983 | 175,545 | | Total Liabilities & Stockholders' Equity | 343,582 | 354,161 | [Condensed Consolidated Statements of Operations](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q1 2025 total revenue was $15.388 million, with increased expenses leading to an operating loss of $14.434 million and a net loss of $13.579 million, or $0.27 per share Condensed Consolidated Statements of Operations (Excerpt) | Item | Three Months Ended March 31, 2025 (thousand USD) | Three Months Ended March 31, 2024 (thousand USD) | | :--- | :--- | :--- | | **Revenue:** | | | | Viatris collaboration arrangement | 15,388 | 14,503 | | Total Revenue | 15,388 | 14,503 | | **Costs and Expenses:** | | | | Research and development | 11,452 | 8,968 | | Selling, general and administrative | 18,370 | 16,742 | | Total costs and expenses | 29,822 | 25,710 | | Operating loss | (14,434) | (11,207) | | Net loss | (13,579) | (11,664) | | Net loss per share, basic and diluted | (0.27) | (0.24) | | Non-GAAP net loss | (8,618) | (4,544) | YUPELRI Net Sales and Stock-Based Compensation Expense | Item | Three Months Ended March 31, 2025 (thousand USD) | Three Months Ended March 31, 2024 (thousand USD) | | :--- | :--- | :--- | | YUPELRI net sales (100% recognized by Viatris) | 58,344 | 55,226 | | YUPELRI net sales (35% implied by Theravance Biopharma) | 20,420 | 19,329 | | **Stock-based compensation expense:** | | | | Research and development | 1,070 | 1,465 | | Selling, general and administrative | 3,807 | 3,764 | | Total stock-based compensation expense | 4,877 | 5,229 | [Reconciliation of GAAP to Non-GAAP Net Loss](index=10&type=section&id=Reconciliation%20of%20GAAP%20to%20Non-GAAP%20Net%20Loss) This section reconciles GAAP net loss of $13.579 million to non-GAAP net loss of $8.618 million, adjusting for stock-based compensation, non-cash interest, and income tax Reconciliation of GAAP to Non-GAAP Net Loss | Item | Three Months Ended March 31, 2025 (thousand USD) | Three Months Ended March 31, 2024 (thousand USD) | | :--- | :--- | :--- | | GAAP net loss | (13,579) | (11,664) | | **Adjustments:** | | | | Stock-based compensation expense | 4,877 | 5,229 | | Non-cash interest expense | 643 | 629 | | Income tax (benefit) expense | (559) | 1,262 | | Non-GAAP net loss | (8,618) | (4,544) | [Additional Information](index=4&type=section&id=Additional%20Information) This section provides details on the conference call, forward-looking statements, and the company's use of non-GAAP financial measures [Conference Call and Webcast](index=4&type=section&id=Conference%20Call%20and%20Webcast) A conference call and webcast discussing Q1 financial results was held at 5:00 PM ET, with a replay available on the company website for 30 days - The conference call and webcast were held at **5:00 PM ET**[15](index=15&type=chunk) - A replay will be available on the company's website for **30 days**, through June 7, 2025[16](index=16&type=chunk) [Forward-Looking Statements](index=6&type=section&id=Forward-Looking%20Statements) This press release contains forward-looking statements under the Private Securities Litigation Reform Act of 1995, subject to risks and uncertainties that may cause actual results to differ materially - This press release contains **forward-looking statements** as defined by the Private Securities Litigation Reform Act of 1995[25](index=25&type=chunk) - Forward-looking statements involve expectations regarding future profitability, expenses, cash use, **YUPELRI** sales growth, milestone and royalty payments, regulatory strategies, and clinical study timing[25](index=25&type=chunk) - These statements are subject to risks, uncertainties, changes in circumstances, assumptions, and other factors that could cause actual results to differ materially from forward-looking statements[25](index=25&type=chunk) [Non-GAAP Financial Measures](index=7&type=section&id=Non-GAAP%20Financial%20Measures) Theravance Biopharma provides non-GAAP profitability targets and measures to aid investor assessment of future performance, emphasizing their supplementary role to GAAP results - Theravance Biopharma provides **non-GAAP profitability targets** and **non-GAAP measures** to assist investors in evaluating future performance[27](index=27&type=chunk) - Non-GAAP measures provide better indicators of business performance by excluding items that may not represent core operating results and the company's cash position[27](index=27&type=chunk) - Non-GAAP measures should be considered supplementary to, not a substitute for or in isolation from, the company's actual GAAP results and other targets[27](index=27&type=chunk)

Core Viewpoint - Theravance Biopharma reported its financial and operational results for Q1 2025, highlighting growth in YUPELRI sales and advancements in clinical trials for ampreloxetine, while also addressing ongoing strategic reviews to enhance shareholder value [1][2][8]. Financial Performance - Total revenue for Q1 2025 was $15.4 million, entirely from Viatris collaboration revenue, which increased by $0.9 million, or 6%, compared to Q1 2024 [4][29]. - YUPELRI net sales reached $58.3 million, reflecting a 6% increase year-over-year [5][6]. - The company reported a net loss of $13.6 million for Q1 2025, compared to a net loss of $11.7 million in Q1 2024 [13][29]. Operational Highlights - The CYPRESS study for ampreloxetine is nearing completion, with final patient enrollment expected by late summer 2025 [5][6]. - Customer demand for YUPELRI grew by 5% in Q1 2025, with doses pulled through the hospital channel increasing by 48% year-over-year [6][5]. - The company presented data at the American Academy of Neurology 2025 Annual Meeting, showcasing the pharmacodynamic effects of ampreloxetine [6]. Strategic Initiatives - A Strategic Review Committee has been formed to evaluate alternatives aimed at unlocking shareholder value [8]. - The company continues to expect full-year 2025 R&D expenses between $32 million and $38 million, and SG&A expenses between $50 million and $60 million [14]. Market Context - Ampreloxetine is being developed for symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA), with potential for significant clinical benefits [15][19]. - There are approximately 50,000 MSA patients in the US, with 70-90% experiencing nOH symptoms, indicating a substantial unmet medical need [17][18].

Core Insights - Theravance Biopharma announced the presentation of analyses from the initial Phase 3 program of ampreloxetine at the International MSA Congress, highlighting its potential to address neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA) [1][2] - The ongoing registrational study (CYPRESS) aims to evaluate the efficacy and durability of ampreloxetine in treating symptomatic nOH in MSA patients [4][5] Company Overview - Theravance Biopharma focuses on developing innovative therapies, with ampreloxetine being a late-stage investigational norepinephrine reuptake inhibitor for symptomatic nOH in MSA patients [3][10] - The company has received Orphan Drug Designation for ampreloxetine in the US, indicating its commitment to addressing unmet medical needs in rare diseases [3] Clinical Study Details - The CYPRESS study is a multi-center, randomized withdrawal trial evaluating ampreloxetine's efficacy after 20 weeks of treatment, with the primary endpoint being the change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score [4] - Previous studies (Study 0169 and Study 0170) assessed the efficacy and safety of ampreloxetine, with Study 0170 showing a significant benefit in MSA patients, indicated by a 72% reduction in treatment failure odds compared to placebo [5][7] Disease Context - Multiple system atrophy (MSA) is a progressive disorder affecting movement and autonomic functions, with approximately 50,000 patients in the US, of which 70-90% experience nOH symptoms [8][9] - Neurogenic orthostatic hypotension (nOH) is characterized by a significant drop in blood pressure upon standing, leading to debilitating symptoms such as dizziness and fainting [9]

Company Overview - Theravance Biopharma, Inc. focuses on delivering innovative medicines that improve patients' lives, leveraging decades of expertise in the biopharmaceutical industry [3] - The company has developed the FDA-approved YUPELRI® (revefenacin) inhalation solution for the maintenance treatment of chronic obstructive pulmonary disease (COPD) [3] - Ampreloxetine, a late-stage investigational drug, is being developed for symptomatic neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA), with potential to be a first-in-class therapy [3] Upcoming Financial Results - Theravance Biopharma will report its first quarter 2025 financial results and provide a business update on May 8, 2025, after market close [1] - A conference call and webcast will be held on the same day at 5:00 pm EDT [1][2] Conference Call Participation - Participants can join the live call by dialing (800) 715-9871 from the US or (646) 307-1963 for international callers, using Conference ID 3369474 [2] - The conference call will also be available for live streaming on Theravance Biopharma's website [2] - A replay of the webcast will be accessible for 30 days until June 7, 2025 [2]

Core Insights - Theravance Biopharma announced new analyses supporting the efficacy and safety of ampreloxetine for treating symptomatic neurogenic orthostatic hypotension (nOH) at the 77th Annual Meeting of the American Academy of Neurology [1][2] Group 1: Efficacy of Ampreloxetine - The Phase 3 program included two trials focusing on patients with nOH due to multiple system atrophy (MSA), Parkinson's Disease, and pure autonomic failure, with ongoing studies supporting its potential for registration [2][3] - In Study 0169, patients treated with ampreloxetine showed a mean increase of 58% in venous plasma norepinephrine levels after 4 weeks, with a 79% increase in MSA patients [6][12] - The pharmacodynamic effects demonstrated durable target engagement and a physiological effect on blood pressure, particularly in MSA patients [2][6] Group 2: Safety Profile - Analyses indicated no worsening of supine hypertension in patients treated with ampreloxetine, a significant concern with existing therapies [5][7] - Patients on ampreloxetine did not experience increased overnight supine hypertension compared to those on placebo, suggesting a favorable safety profile [7][8] - The unique mechanism of action of ampreloxetine may allow for effective treatment of nOH without the side effects associated with high blood pressure in the supine position [8][10] Group 3: Ongoing Studies and Future Prospects - The ongoing CYPRESS study aims to evaluate the efficacy and durability of ampreloxetine in MSA patients with symptomatic nOH, with a primary endpoint focused on changes in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score [11][12] - The company plans to file a New Drug Application (NDA) for ampreloxetine if results from the ongoing studies are supportive [10][12] - The potential for ampreloxetine to become a first-in-class therapy for nOH in MSA patients is highlighted, addressing a significant unmet medical need [10][14]

It has been about a month since the last earnings report for Theravance Biopharma (TBPH) . Shares have added about 0.4% in that time frame, outperforming the S&P 500.Will the recent positive trend continue leading up to its next earnings release, or is Theravance Bio due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important drivers.How Have Estimates Been Moving Since ...