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 ...

Core Insights - Theravance Biopharma is presenting new analyses of the Phase 3 program for ampreloxetine at the upcoming AAN Meeting, highlighting its selective pharmacodynamic profile [1][2] - The ongoing CYPRESS Study 197 aims to confirm the efficacy of ampreloxetine in treating neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA) [1][4] Company Overview - Theravance Biopharma focuses on developing innovative therapies, including ampreloxetine, a once-daily norepinephrine reuptake inhibitor for symptomatic nOH in MSA patients [3][9] - The company has received Orphan Drug Designation for ampreloxetine in the U.S. and plans to file a New Drug Application (NDA) if ongoing studies yield positive results [3] Clinical Study Details - The CYPRESS Study 197 is a multi-center, randomized withdrawal study evaluating the efficacy of ampreloxetine after 20 weeks of treatment, with a primary endpoint of change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score [4] - Previous studies (Study 169 and Study 170) indicated that while Study 169 did not meet its primary endpoint, a subgroup analysis suggested significant benefits for MSA patients, showing a 72% reduction in treatment failure odds with ampreloxetine [5][6] Disease Context - Multiple system atrophy (MSA) is a progressive disorder affecting movement and autonomic functions, with approximately 50,000 patients in the U.S., and 70-90% experiencing nOH symptoms [7][8] - Neurogenic orthostatic hypotension (nOH) is characterized by significant drops in blood pressure upon standing, leading to debilitating symptoms such as dizziness and fainting [8]

Financial Performance - YUPELRI net sales increased by 8% to $238.6 million in 2024 compared to 2023, with hospital volumes growing 41%[15] - TRELEGY's global net sales reached $3.46 billion in 2024, exceeding the threshold for a $50 million milestone payment[17] - The company received a $50 million milestone payment from Royalty Pharma related to TRELEGY's 2024 global net sales[17] - Total 2024 TRELEGY global net sales represented a 26% increase compared to 2023, with expectations of generating global peak sales of $4.0 billion in 2026[40] - A total of $150.0 million in potential Milestone Payments remain available, with eligibility for $25.0 million if 2025 TRELEGY global net sales reach approximately $3.06 billion[40] - YUPELRI's implied net sales share for Theravance Biopharma was $83.5 million in 2024, reflecting an 8% increase from 2023[29] - For the year ended December 31, 2024, Theravance Biopharma recognized a net loss of $56.4 million, with a cumulative net loss of $965.5 million since the spin-off from Innoviva, Inc.[117] Strategic Initiatives - The company has formed a Strategic Review Committee to assess strategic alternatives aimed at unlocking shareholder value[18] - The company completed the sale of its equity interests in Theravance Respiratory Company for approximately $1.11 billion, retaining future value through contingent milestone payments[38] - The company is undergoing a strategic review process to assess alternatives for unlocking shareholder value, which may be time-consuming and disruptive[144] - The company has incurred substantial expenses related to identifying and evaluating potential strategic alternatives, which may impact its operating results[144] Product Development and Regulatory Affairs - Ampreloxetine Phase 3 clinical study enrollment is on track for completion in mid-2025, with data expected approximately six months later[16] - Ampreloxetine has received Orphan Drug Designation from the FDA for the treatment of symptomatic nOH in MSA patients[36] - Regulatory approval processes for pharmaceutical products are extensive, requiring rigorous clinical studies and compliance with FDA standards[52] - The ability to market products outside the US depends on receiving marketing authorizations from regulatory authorities, similar to FDA approval processes[64] - Regulatory compliance is critical, as failure to meet FDA standards could lead to penalties and adversely affect the company's financial condition[153] - The FDA regulates marketing and promotion of drugs, allowing only claims consistent with approved labeling[60] - The company must navigate complex legal and regulatory environments regarding pricing and reimbursement, which could impact market acceptance and sales of its products[70] Intellectual Property - The company owns a total of 177 issued US patents and 1,070 granted foreign patents as of December 31, 2024, which are crucial for protecting its technology[76] - The patent rights for YUPELRI (revefenacin) inhalation solution include multiple US patents expiring between 2025 and 2039, providing a competitive advantage[76] - The company’s patent applications may be eligible for limited patent term extensions under the Hatch-Waxman Act, which could extend patent protection by up to five years[80] - The company has multiple patents protecting YUPELRI, with expiration dates ranging from 2025 to 2039, but faces competition from generic versions, which could significantly impact its market position[161] - The FDA has imposed a stay of approval on generic versions of YUPELRI until May 2026 due to ongoing patent infringement lawsuits[85] - As of February 28, 2025, the company has settled litigation with several generic companies, allowing them to market their generic versions of YUPELRI starting April 23, 2039[88] Market Competition - The commercial success of YUPELRI is contingent on its acceptance by physicians, patients, and third-party payors, with potential declines in revenue if acceptance does not grow[123] - The company faces substantial competition from larger firms, which may hinder its ability to discover and commercialize products successfully[118] - YUPELRI competes with short-acting nebulized bronchodilators and new products like Verona Pharma's ensifentrine and Sanofi's Dupixent, which could affect its market position[148] - The company faces substantial competition from larger companies with more resources, which may hinder its ability to successfully develop and commercialize new medicines[145] Operational Risks - The company relies on third-party contract manufacturing organizations for production, mitigating the need for internal manufacturing capacity[48] - The company relies on single-source suppliers for YUPELRI's API and drug product, posing risks if these suppliers fail to meet demand[149] - Significant disruptions to information technology systems or security breaches could adversely affect the company's operations and financial results[181] - The distribution of YUPELRI through various suppliers may be impacted by security breaches, potentially leading to reduced revenue[184] Employee and Corporate Culture - The company has 97 employees as of December 31, 2024, with 86 based in the US and 11 in Dublin, Ireland[98] - The employee engagement survey for 2024 achieved a participation rate of 96% with an average score of 4.4 out of 5[102] - The company emphasizes a culture of diversity, equity, inclusion, and belonging, supported by employee-led groups[105] - The company offers a competitive total rewards package, including base salary, cash bonuses, equity incentives, and health benefits[107] - The company has implemented workplace safety initiatives to comply with health and safety standards[111] Financial Position and Future Outlook - The company had cash, cash equivalents, and marketable securities of approximately $88.4 million as of December 31, 2024, which is expected to meet anticipated operating needs for at least the next twelve months[193] - Future capital needs will depend on various factors, including support for YUPELRI commercialization strategies and the ampreloxetine program[194] - The company may need to seek additional funding through public or private equity, debt financings, or collaborations, which could dilute current shareholders' ownership[197] - The company is vulnerable to geopolitical and economic conditions, including the ongoing war in Ukraine and inflation, which may negatively affect its operations and stock price[186] - Future tax reforms and changes in tax laws could materially impact the company's financial condition and results of operations[206] - The company may be subject to challenges regarding its tax structure and transfer pricing arrangements, which could result in increased tax liabilities[209] Compliance and Reporting - The company is subject to reporting obligations under the Exchange Act, including the requirements of Section 404 of the Sarbanes-Oxley Act of 2002[212] - Effective internal controls are crucial for the reliability of financial reporting and the preparation of financial statements[212] - Any failure to maintain effective internal controls could adversely affect the company's business, financial position, and results of operations[212] - The management is responsible for establishing and maintaining adequate internal control over financial reporting[212] - Significant demands are placed on management and operational resources due to reporting obligations[212]

Financial Performance - Theravance Biopharma reported a fourth-quarter 2024 adjusted net loss of 5 cents per share, consistent with the Zacks Consensus Estimate, compared to earnings of 3 cents per share in the same quarter last year [1] - Total revenues for the quarter were $18.8 million, slightly exceeding the Zacks Consensus Estimate of $18.0 million, and reflecting a year-over-year increase of 6.8% due to higher collaboration revenues from partner Viatris [3] - The reported loss, including share-based compensation, income tax expense, and non-cash interest expense, was 31 cents per share, compared to a loss of 17 cents in the year-ago quarter [2] Collaboration and Revenue Sources - The revenue was entirely derived from Viatris' collaboration revenues related to Yupelri (revefenacin) sales, which increased by 8% year over year in the fourth quarter [4] - Viatris recorded U.S. net sales of Yupelri at $66.7 million, marking a 10% year-over-year increase [6] - Viatris retains 65% of the profits from Yupelri sales, while Theravance receives 35%, which includes its share of net sales and proportionate costs [5] Expenses and Financial Guidance - Research and development expenses (excluding share-based compensation) totaled $8.1 million, up nearly 23% from the previous year, while selling, general, and administrative expenses increased around 23% year over year to $14.1 million [9] - For 2025, Theravance expects adjusted R&D expenses to be in the range of $32-$38 million and adjusted SG&A expenses between $50 million and $60 million, with share-based compensation expenses projected at $18-$20 million [12] Cash Position and Future Outlook - As of December 31, 2024, Theravance had cash, cash equivalents, and marketable securities amounting to $88.4 million, down from $91.4 million as of September 30, 2024 [11] - The company anticipates adjusted losses and cash burn in 2025 to be similar to 2024 levels, with an adjusted loss of $16 million and cash burn of $14 million recorded in 2024 [13] Pipeline Developments - Theravance is developing ampreloxetine (TD-9855), a norepinephrine reuptake inhibitor for treating neurogenic orthostatic hypotension in patients with multiple system atrophy [14] - The phase III CYPRESS study for ampreloxetine was initiated in 2024, with patient enrollment expected to complete by mid-2025, and top-line data anticipated six months post-enrollment [15]