Theravance Biopharma(TBPH) - 2025 Q2 - Quarterly Results

Executive Summary and Corporate Update Theravance Biopharma reported strong Q2 2025 performance, driven by commercial growth, strategic asset monetization, and clinical development progress Q2 2025 Performance Overview Theravance Biopharma reported strong Q2 2025 performance, fueled by YUPELRI's commercial growth, a China approval milestone, and strategic TRELEGY royalty monetization, with ampreloxetine Phase 3 enrollment progressing - Strong execution across the business, driven by commercial growth, disciplined operations, and continued progress on ampreloxetine[3] - YUPELRI posted another strong quarter in the U.S., and its recent approval in China triggered a $7.5 million milestone payment[3] - Completion of the strategic monetization of TRELEGY royalty interest brought in $225 million, meaningfully strengthening the business[3] - Enrollment in the pivotal Phase 3 CYPRESS study for ampreloxetine is on track for completion by late summer, with top-line data anticipated approximately six months later[3] Second Quarter Operational Highlights Q2 operational highlights include strong YUPELRI sales, ampreloxetine Phase 3 progress, and the strategic TRELEGY royalty sale YUPELRI (revefenacin) Performance YUPELRI achieved $66.3 million in U.S. net sales in Q2 2025, a 22% year-over-year increase, supported by customer demand growth and a $7.5 million China approval milestone YUPELRI Performance Metrics | Metric | Q2 2025 Value | Year-over-Year Change | | :-------------------------------- | :------------ | :-------------------- | | YUPELRI U.S. Net Sales (Viatris) | $66.3 million | +22% | | Customer Demand Growth | 4% | | | Hospital Channel Doses Growth | | +31% | | China Approval Milestone Payment | $7.5 million | N/A | - Net sales benefited from continued improvement to net pricing and a one-time favorable adjustment; excluding this, year-over-year net sales growth would have been in the mid-teens[6] Ampreloxetine Development Update The pivotal Phase 3 CYPRESS study for ampreloxetine is on track for enrollment completion by late summer, with pre-launch activities advancing for potential approval - Pivotal Phase 3 CYPRESS study enrollment nearing completion with final patient expected to be enrolled by late summer; top-line data anticipated approximately six months later[9] - Advancing pre-launch activities across medical affairs and commercial functions in preparation for the potential approval of ampreloxetine[9] TRELEGY Royalty Interest Sale Theravance Biopharma completed the sale of its TRELEGY ELLIPTA royalty interest to GSK for a $225 million cash payment, resulting in a $75.1 million net gain - Completed sale of TRELEGY ELLIPTA royalty interest to GSK for $225 million[5] - One-time cash payment of $225 million received in late Q2 2025[9] - Net gain on realized contingent milestone and royalty assets was $75.1 million, based on sales proceeds of $225.0 million less carrying value and transaction costs[11] - This transaction is the first outcome of the Strategic Review Committee's ongoing efforts to assess strategic alternatives and enhance shareholder value[9] Second Quarter Financial Results Q2 financial results highlight revenue growth, controlled expenses, a net income turnaround, and a strengthened cash position Revenue Breakdown Total revenue for Q2 2025 surged to $26.2 million, an 83.7% increase year-over-year, driven by Viatris collaboration revenue and a $7.5 million licensing payment Revenue by Type | Revenue Type | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Change YoY | | :-------------------------- | :--------------------- | :--------------------- | :--------- | | Viatris collaboration agreement | $18,695 | $14,256 | +31% | | Licensing revenue | $7,500 | $0 | N/A | | Total Revenue | $26,195 | $14,256 | +83.7% | - Viatris collaboration revenue represents the Company's 35% share of net sales of YUPELRI, as well as its proportionate amount of total shared commercial costs[8] - Theravance Biopharma's implied 35% share of net sales of YUPELRI for Q2 2025 was $23.2 million, a 22% increase compared to the same period in 2024[8] Operating Expenses Q2 2025 R&D and SG&A expenses saw slight increases to $10.5 million and $18.4 million respectively, while share-based compensation decreased to $4.5 million Operating Expenses by Type | Expense Type | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Change YoY | | :-------------------------- | :--------------------- | :--------------------- | :--------- | | Research and Development | $10,490 | $9,954 | +5.4% | | Selling, General and Administrative | $18,430 | $17,056 | +8.1% | | Share-Based Compensation | $4,543 | $5,376 | -15.4% | Net Income (Loss) and Non-GAAP Net Loss The company achieved a net income of $54.8 million in Q2 2025, a significant turnaround from a prior-year loss, primarily due to a $75.1 million gain from the TRELEGY royalty sale Net Income (Loss) and Non-GAAP Net Loss | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | | :-------------------------- | :--------------------- | :--------------------- | | Net Income (Loss) | $54,835 | $(16,529) | | Non-GAAP Net Loss from Operations | $(4,225) | $(6,250) | - The increase in net income was driven by the $75.1 million net gain on contingent milestone and royalty assets arising from the sale of the remaining interest in TRELEGY royalties[11] - Income tax expense for Q2 2025 was $18.4 million, compared to $1.3 million in Q2 2024, primarily due to the net gain on royalty assets[11] Cash Position Theravance Biopharma's cash, cash equivalents, and marketable securities significantly increased to $338.8 million by June 30, 2025, largely due to the TRELEGY royalty sale proceeds Cash, Cash Equivalents and Marketable Securities | Metric | June 30, 2025 (in thousands) | Dec 31, 2024 (in thousands) | | :------------------------------------------ | :--------------------------- | :-------------------------- | | Cash, cash equivalents and short-term marketable securities | $338,804 | $88,350 | - Strong balance sheet with $339 million in cash and no debt[5] 2025 Financial Guidance Theravance Biopharma maintains its full-year 2025 expense guidance, with non-GAAP net income and cash burn projected similar to 2024 Full Year 2025 Outlook The company reaffirms its 2025 guidance for R&D expenses between $32-38 million and SG&A between $50-60 million, with share-based compensation at $18-20 million Full Year 2025 Guidance | Metric | Full Year 2025 Guidance (in millions) | | :------------------------------------------ | :---------------------- | | R&D Expenses (excluding share-based comp.) | $32 to $38 | | SG&A Expenses (excluding share-based comp.) | $50 to $60 | | Share-Based Compensation Expenses | $18 to $20 | - Non-GAAP Net Income (Loss) from Operations and Cash Burn in 2025 are expected to be similar to levels incurred in 2024, excluding one-time, non-recurring revenue and income items[16] Product and Clinical Program Details This section details ampreloxetine as an investigational nOH therapy for MSA, outlining its Phase 3 study and the underlying disease About Ampreloxetine Ampreloxetine is an investigational, once-daily selective norepinephrine reuptake inhibitor for symptomatic nOH in MSA, with Orphan Drug Designation and potential for NDA filing - Ampreloxetine is an investigational, once-daily, selective norepinephrine reuptake inhibitor in development for symptomatic nOH in patients with MSA[15] - Unique benefits reported include increased norepinephrine levels, favorable blood pressure impact, clinically meaningful and durable symptom improvement, and no signal for worsening of supine hypertension[15] - Granted Orphan Drug Designation in the US for symptomatic nOH in MSA; plans to file an NDA for full approval if Phase 3 CYPRESS study results are supportive[15] About CYPRESS (Study 0197), a Phase 3 Study Study 0197 (CYPRESS) is a registrational Phase 3 randomized withdrawal study evaluating ampreloxetine's efficacy and durability in MSA patients with symptomatic nOH - Study 0197 (CYPRESS) is a registrational Phase 3, multi-center, randomized withdrawal study currently enrolling[17] - Evaluates the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment[17] - The primary endpoint of the study is change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score[17] About Multiple System Atrophy (MSA) and Symptomatic Neurogenic Orthostatic Hypotension (nOH) MSA is a progressive brain disorder, frequently associated with nOH, a debilitating condition affecting 70-90% of the approximately 50,000 US MSA patients - MSA is a progressive brain disorder affecting movement, balance, and autonomic nervous system function[18] - Neurogenic orthostatic hypotension (nOH), a sudden drop in blood pressure upon standing, affects 70-90% of the approximately 50,000 MSA patients in the US[18] - nOH is a debilitating condition resulting in symptoms such as dizziness, lightheadedness, fainting, fatigue, blurry vision, weakness, trouble concentrating, and head and neck pain[19] About Theravance Biopharma Theravance Biopharma focuses on impactful medicines, leveraging expertise for FDA-approved YUPELRI and advancing ampreloxetine - Theravance Biopharma, Inc.'s focus is to deliver Medicines that Make a Difference in people's lives[20] - Leverages decades of expertise, leading to the development of FDA-approved YUPELRI (revefenacin) for COPD[20] - Ampreloxetine, its late-stage investigational therapy for symptomatic nOH in MSA, has the potential to be a first-in-class therapy[20] Non-GAAP Financial Measures Non-GAAP financial measures adjust GAAP net income for non-cash and non-recurring items, offering insights into core operating results and cash - Non-GAAP profit (loss) consists of GAAP net income (loss) before taxes less share-based compensation, non-cash interest expense, non-cash impairment expense, and non-recurring revenue and income items[10] - Non-GAAP profitability targets and metrics provide meaningful information to assist investors by excluding items not indicative of core operating results and the Company's cash position[26] - Non-GAAP measures should be considered in addition to, not as a substitute for, or in isolation from, the Company's actual GAAP results[26] - A reconciliation of non-GAAP net loss to its corresponding GAAP measure is not available on a forward-looking basis without unreasonable effort due to the uncertainty and potential variability of future expenses[27] Financial Statements This section presents condensed consolidated balance sheets, statements of operations, and GAAP to non-GAAP net loss reconciliation Condensed Consolidated Balance Sheets Total assets increased to $426.0 million by June 30, 2025, driven by a significant rise in cash and equivalents, while liabilities and shareholders' equity also grew Condensed Consolidated Balance Sheets | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :------------------------------------------ | :--------------------------- | :------------------------------- | | Cash and cash equivalents and short-term marketable securities | $338,804 | $88,350 | | Receivables from milestone and royalty assets | $0 | $50,000 | | Future contingent milestone and royalty assets | $0 | $144,200 | | Total assets | $426,035 | $354,161 | | Total current liabilities | $54,633 | $32,085 | | Shareholders' equity | $224,848 | $175,545 | - The significant increase in cash and total assets is largely due to the $225 million proceeds from the TRELEGY royalty sale, which also eliminated the 'Future contingent milestone and royalty assets' line item[30] Condensed Consolidated Statements of Operations Q2 2025 saw total revenue of $26.2 million and a net income of $54.8 million, a substantial improvement from Q2 2024's net loss, primarily due to the TRELEGY royalty asset gain Condensed Consolidated Statements of Operations | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | | :------------------------------------------ | :---------------------------------------------- | :---------------------------------------------- | | Total Revenue | $26,195 | $14,256 | | Total Costs and Expenses | $28,920 | $29,961 | | Loss from operations | $(2,725) | $(15,705) | | Net gain on realized contingent milestone and royalty assets | $75,137 | $0 | | Net income (loss) | $54,835 | $(16,529) | | Net income (loss) per share - basic | $1.09 | $(0.34) | | Net income (loss) per share - diluted | $1.08 | $(0.34) | | Non-GAAP net loss | $(4,225) | $(6,250) | - The significant net income in Q2 2025 was primarily driven by the $75.1 million net gain from the sale of TRELEGY royalty assets[33] Reconciliation of GAAP Net Income (Loss) to Non-GAAP Net Loss GAAP net income of $54.8 million for Q2 2025 was adjusted to a non-GAAP net loss of $4.2 million, primarily by excluding non-recurring revenue and the TRELEGY royalty asset gain Reconciliation of GAAP Net Income (Loss) to Non-GAAP Net Loss | Adjustment Item | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | | :------------------------------------------ | :---------------------------------------------- | :---------------------------------------------- | | GAAP net income (loss) | $54,835 | $(16,529) | | Licensing revenue (non-recurring) | $(7,500) | $0 | | Net gain on realized contingent milestone and royalty assets (non-recurring) | $(75,137) | $0 | | Non-cash impairment expense of long-lived assets | $0 | $2,951 | | Share-based compensation expense | $4,543 | $5,376 | | Non-cash interest expense | $663 | $644 | | Income tax expense | $18,371 | $1,308 | | Non-GAAP net loss | $(4,225) | $(6,250) | Additional Information This section provides details on the conference call, forward-looking statements, and investor relations contact information Conference Call and Live Webcast Theravance Biopharma held a conference call and webcast on August 12, 2025, to discuss Q2 results, with a replay available on the company's website until September 11, 2025 - Conference call and live webcast held on August 12, 2025, at 5:00 pm ET / 2:00 pm PT / 9:00 pm GMT[13] - A replay of the webcast will be available on Theravance Biopharma's website for 30 days through September 11, 2025[14] Forward-Looking Statements This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from projections - The press release contains "forward-looking" statements regarding goals, plans, objectives, expectations, and future events, covered by safe harbor provisions[24] - Statements are subject to risks, uncertainties, changes in circumstances, assumptions, and other factors that may cause actual results to be materially different[24] - Important factors include risks related to cash requirements, milestone achievement, delays in clinical studies, regulatory decisions, dependence on third parties, and intellectual property protection[24] Contact Information Investor Relations contact details are provided for further inquiries - Investor Relations Contact: investor.relations@theravance.com, 650-808-4045[28]