Theravance Biopharma(TBPH) - 2025 Q1 - Quarterly Results

Executive Summary & Operational Highlights This section outlines Theravance Biopharma's Q1 2025 financial and operational performance, emphasizing product updates and strategic initiatives First Quarter 2025 Overview 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] - Commercial collaboration for YUPELRI achieved robust sales growth, particularly strong in the hospital setting[3] - TRELEGY again delivered strong performance, with patient enrollment for the CYPRESS study nearing completion[3] Product & Pipeline Updates 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) 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] 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] Ampreloxetine (CYPRESS Study) 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][9] - 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] - 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] 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 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 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 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 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 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 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 This section outlines the company's strategic review committee and its ongoing efforts to evaluate alternatives for shareholder value creation Strategic Review Committee 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] - The committee's objective is to evaluate all strategic alternatives to unlock shareholder value[10] - The strategic review is ongoing, and no additional details are available at this time[10] Product Information & Disease Background 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 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] - 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] - 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] About Multiple System Atrophy (MSA) and nOH 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] - 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][21] - Approximately 50,000 MSA patients in the U.S., with 70-90% experiencing nOH symptoms, many remaining symptomatic despite existing therapies[20] About Theravance Biopharma 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] - The company has developed FDA-approved YUPELRI for the maintenance treatment of COPD[22] - Ampreloxetine is its late-stage investigational drug, poised to be a first-in-class therapy for symptomatic nOH in MSA patients[22] Financial Statements 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 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 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 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 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 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] - A replay will be available on the company's website for 30 days, through June 7, 2025[16] Forward-Looking Statements 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] - 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] - 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] Non-GAAP Financial Measures 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] - 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] - 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]