[Executive Summary and Corporate Update](index=1&type=section&id=Executive%20Summary%20and%20Corporate%20Update) Theravance Biopharma reported strong Q2 2025 performance, driven by commercial growth, strategic asset monetization, and clinical development progress [Q2 2025 Performance Overview](index=1&type=section&id=Q2%202025%20Performance%20Overview) 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](index=3&type=chunk) - YUPELRI posted another strong quarter in the U.S., and its recent approval in China triggered a **$7.5 million** milestone payment[3](index=3&type=chunk) - Completion of the strategic monetization of TRELEGY royalty interest brought in **$225 million**, meaningfully strengthening the business[3](index=3&type=chunk) - 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](index=3&type=chunk) [Second Quarter Operational Highlights](index=1&type=section&id=Second%20Quarter%20Operational%20Highlights) Q2 operational highlights include strong YUPELRI sales, ampreloxetine Phase 3 progress, and the strategic TRELEGY royalty sale [YUPELRI (revefenacin) Performance](index=1&type=section&id=YUPELRI%20%28revefenacin%29%20Performance) 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](index=6&type=chunk) [Ampreloxetine Development Update](index=1&type=section&id=Ampreloxetine%20Development%20Update) 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](index=9&type=chunk) - Advancing pre-launch activities across medical affairs and commercial functions in preparation for the potential approval of ampreloxetine[9](index=9&type=chunk) [TRELEGY Royalty Interest Sale](index=1&type=section&id=TRELEGY%20Royalty%20Interest%20Sale) 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](index=5&type=chunk) - One-time cash payment of **$225 million** received in late Q2 2025[9](index=9&type=chunk) - 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](index=11&type=chunk) - This transaction is the first outcome of the Strategic Review Committee's ongoing efforts to assess strategic alternatives and enhance shareholder value[9](index=9&type=chunk) [Second Quarter Financial Results](index=2&type=section&id=Second%20Quarter%20Financial%20Results) Q2 financial results highlight revenue growth, controlled expenses, a net income turnaround, and a strengthened cash position [Revenue Breakdown](index=2&type=section&id=Revenue%20Breakdown) 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](index=8&type=chunk) - 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](index=8&type=chunk) [Operating Expenses](index=3&type=section&id=Operating%20Expenses) 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](index=3&type=section&id=Net%20Income%20%28Loss%29%20and%20Non-GAAP%20Net%20Loss) 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](index=11&type=chunk) - 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](index=11&type=chunk) [Cash Position](index=3&type=section&id=Cash%20Position) 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](index=5&type=chunk) [2025 Financial Guidance](index=4&type=section&id=2025%20Financial%20Guidance) 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](index=4&type=section&id=Full%20Year%202025%20Outlook) 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](index=16&type=chunk) [Product and Clinical Program Details](index=4&type=section&id=Product%20and%20Clinical%20Program%20Details) This section details ampreloxetine as an investigational nOH therapy for MSA, outlining its Phase 3 study and the underlying disease [About Ampreloxetine](index=4&type=section&id=About%20Ampreloxetine) 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](index=15&type=chunk) - 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](index=15&type=chunk) - 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](index=15&type=chunk) [About CYPRESS (Study 0197), a Phase 3 Study](index=5&type=section&id=About%20CYPRESS%20%28Study%200197%29%2C%20a%20Phase%203%20Study) 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](index=17&type=chunk) - Evaluates the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after **20 weeks of treatment**[17](index=17&type=chunk) - The primary endpoint of the study is change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score[17](index=17&type=chunk) [About Multiple System Atrophy (MSA) and Symptomatic Neurogenic Orthostatic Hypotension (nOH)](index=5&type=section&id=About%20Multiple%20System%20Atrophy%20%28MSA%29%20and%20Symptomatic%20Neurogenic%20Orthostatic%20Hypotension%20%28nOH%29) 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](index=18&type=chunk) - 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](index=18&type=chunk) - 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](index=19&type=chunk) [About Theravance Biopharma](index=5&type=section&id=About%20Theravance%20Biopharma) 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](index=20&type=chunk) - Leverages decades of expertise, leading to the development of FDA-approved **YUPELRI (revefenacin)** for COPD[20](index=20&type=chunk) - Ampreloxetine, its late-stage investigational therapy for symptomatic nOH in MSA, has the potential to be a first-in-class therapy[20](index=20&type=chunk) [Non-GAAP Financial Measures](index=3&type=section&id=Non-GAAP%20Financial%20Measures) 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](index=10&type=chunk) - 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](index=26&type=chunk) - 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](index=26&type=chunk) - 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](index=27&type=chunk) [Financial Statements](index=8&type=section&id=Financial%20Statements) This section presents condensed consolidated balance sheets, statements of operations, and GAAP to non-GAAP net loss reconciliation [Condensed Consolidated Balance Sheets](index=8&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=30&type=chunk) [Condensed Consolidated Statements of Operations](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) 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](index=33&type=chunk) [Reconciliation of GAAP Net Income (Loss) to Non-GAAP Net Loss](index=11&type=section&id=Reconciliation%20of%20GAAP%20Net%20Income%20%28Loss%29%20to%20Non-GAAP%20Net%20Loss) 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](index=4&type=section&id=Additional%20Information) This section provides details on the conference call, forward-looking statements, and investor relations contact information [Conference Call and Live Webcast](index=4&type=section&id=Conference%20Call%20and%20Live%20Webcast) 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](index=13&type=chunk) - A replay of the webcast will be available on Theravance Biopharma's website for **30 days** through **September 11, 2025**[14](index=14&type=chunk) [Forward-Looking Statements](index=6&type=section&id=Forward-Looking%20Statements) 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](index=24&type=chunk) - Statements are subject to risks, uncertainties, changes in circumstances, assumptions, and other factors that may cause actual results to be materially different[24](index=24&type=chunk) - 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](index=24&type=chunk) [Contact Information](index=7&type=section&id=Contact%20Information) Investor Relations contact details are provided for further inquiries - Investor Relations Contact: **investor.relations@theravance.com**, **650-808-4045**[28](index=28&type=chunk)

Core Insights - Theravance Biopharma reported strong execution in Q2 2025, driven by commercial growth and operational discipline, with significant progress on ampreloxetine and a milestone payment from YUPELRI's approval in China [2][5][10] Financial Performance - Total revenue for Q2 2025 was $26.2 million, comprising $18.7 million from Viatris collaboration and $7.5 million from licensing revenue [10] - Viatris collaboration revenue increased by 31% year-over-year, amounting to $18.7 million in Q2 2025 [10] - Net income for Q2 2025 was $54.8 million, a significant improvement from a net loss of $16.5 million in Q2 2024 [10][30] - Non-GAAP net loss from operations was $4.2 million in Q2 2025, compared to a loss of $6.3 million in the same period in 2024 [10][30] Operational Highlights - YUPELRI net sales reached $66.3 million in Q2 2025, reflecting a 22% increase year-over-year [5][6] - The pivotal Phase 3 CYPRESS study for ampreloxetine is on track for enrollment completion by late summer 2025, with top-line data expected approximately six months later [5][10] - The company completed the sale of its TRELEGY royalty interest to GSK for $225 million, enhancing its financial position [5][10] Cash Position and Guidance - As of June 30, 2025, the company had $339 million in cash and no debt, indicating a strong balance sheet [5][10] - The company anticipates full-year 2025 global net sales to exceed $3.4 billion, with a milestone of $50 million from Royalty Pharma expected to be triggered [5][10] Strategic Focus - The company is focused on disciplined capital allocation and returning excess cash to shareholders, with ongoing evaluations of strategic alternatives to enhance shareholder value [7][10]

Core Viewpoint - Theravance Biopharma, Inc. is set to report its second quarter 2025 financial results and provide a business update on August 12, 2025, after market close [1] Company Overview - Theravance Biopharma focuses on delivering innovative medicines, including the FDA-approved YUPELRI® for chronic obstructive pulmonary disease (COPD) [3] - The company is developing Ampreloxetine, a late-stage investigational drug for neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA), which has the potential to be a first-in-class therapy [3] - Theravance Biopharma is committed to creating and driving shareholder value [3]

Industry Overview - The uncertainty surrounding tariffs and trade measures has impacted economic growth, with President Trump threatening to impose tariffs as high as 200% on pharmaceutical imports to encourage domestic production [1] - Despite these threats, the biotech sector has remained stable, with many global pharmaceutical companies already investing in domestic manufacturing [1] Current Trends - The Zacks Medical-Drugs industry is showing promising trends due to positive pipeline and regulatory developments [2] - Key areas of innovation include rare diseases, next-generation oncology treatments, obesity, immunology, and neuroscience, attracting significant investor interest [3] M&A Activity - M&A activity in the sector remains healthy, indicating growth potential for companies like Catalyst Pharmaceuticals, Zevra Therapeutics, Theravance Biopharma, Aldeyra Therapeutics, and Larimar Therapeutics [3] Industry Characteristics - The Zacks Medical-Drugs industry consists of small to medium-sized drug companies that produce medicines for human and veterinary use, often relying on collaboration payments for revenue [4] Factors Influencing Future Growth - The success of key pipeline candidates in clinical studies can significantly impact stock prices, with successful innovations acting as catalysts [5] - Strong collaboration with larger drugmakers is a positive indicator for small pharma companies, especially when equity investments are involved [6] - Investment in technology and personalized medicine is crucial for smaller companies to thrive in a changing healthcare landscape [7] Performance Metrics - The Zacks Medical-Drugs industry currently holds a Zacks Industry Rank of 96, placing it in the top 39% of 245 Zacks industries, indicating strong prospects [9] - Year-to-date, the industry has risen 5.6%, outperforming the Zacks Medical sector, which has decreased by 2.9%, while slightly underperforming the S&P 500, which has risen by 6.9% [11] Valuation - The industry is currently trading at a trailing 12-month price-to-sales ratio of 2.32, compared to the S&P 500's 5.66 and the Zacks Medical sector's 2.37 [12] Company Highlights - **Catalyst Pharmaceuticals**: Lead drug Firdapse shows strong demand; stock has risen 0.4% this year; earnings estimate for 2025 increased from $2.23 to $2.25 [16][17] - **Theravance Biopharma**: Strong sales from Yupelri; stock has risen 22.6% this year; earnings estimate for 2025 declined from 3 cents to 1 cent [20][21] - **Larimar Therapeutics**: Developing nomlabofusp for Friedreich's ataxia; stock has declined 18.3% this year; loss estimate for 2025 narrowed from $1.90 to $1.89 [24][25] - **Zevra Therapeutics**: Early adoption of Miplyffa exceeds expectations; stock has risen 53.4% this year; earnings estimate for 2025 increased from 31 cents to 76 cents [28][29] - **Aldeyra Therapeutics**: Focused on RASP modulators; stock has declined 0.4% this year; loss estimate for 2025 narrowed from $1.03 to 90 cents [31][32]

Core Viewpoint - Theravance Biopharma announces that Viatris has received regulatory approval in China for YUPELRI® (revefenacin), marking it as the first once-daily nebulized long-acting muscarinic antagonist (LAMA) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in the country [1][7] Financial Impact - The approval triggers a one-time milestone payment of $7.5 million from Viatris to Theravance Biopharma, expected in Q3 2025 [2] - Theravance Biopharma is also eligible for additional sales-based milestones of up to $37.5 million and tiered royalties ranging from 14% to 20% on net sales in China [2] - The company reported a financial position that includes $131 million in cash as of March 31, 2025, and an additional $225 million from the recent sale of TRELEGY royalties to GSK [3] Product Development - Theravance Biopharma is nearing completion of enrollment in the open label portion of CYPRESS, a registrational study for ampreloxetine, which targets symptomatic neurogenic orthostatic hypotension associated with multiple system atrophy [3] - Ampreloxetine has shown potential benefits in increasing norepinephrine levels and improving blood pressure without worsening supine hypertension in MSA patients [4] Study Details - The CYPRESS study (Study 0197) is a Phase 3, multi-center, randomized withdrawal study evaluating the efficacy and durability of ampreloxetine after 20 weeks of treatment [5] - The primary endpoint of the study is the change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score [5] Company Overview - Theravance Biopharma focuses on delivering innovative medicines, with YUPELRI® approved for COPD maintenance treatment and ampreloxetine in late-stage development for symptomatic neurogenic orthostatic hypotension [6][8]

Core Insights - Theravance Biopharma (TBPH) has entered into an agreement to sell its remaining royalty interest in Trelegy Ellipta to GSK plc for $225 million in cash [1][2] - The transaction is part of Theravance's strategic review efforts to maximize shareholder value, with potential additional milestone payments of up to $150 million from Royalty Pharma based on Trelegy Ellipta's net sales in 2025 and 2026 [2][7] - Following the announcement, Theravance's shares increased by 22% [2] Financial Performance - Theravance's stock has increased by 18.5% year-to-date, contrasting with a 1.9% decline in the industry [3] - In February 2025, Theravance received a $50 million milestone payment based on Trelegy Ellipta's net sales of $3.46 billion in 2024, with a similar milestone payment of $150 million contingent on projected sales of approximately $3.41 billion in 2025 and $3.51 billion in 2026 [4][8] Revenue Generation - Theravance generates revenue from its collaboration with Viatris (VTRS) related to the sales of Yupelri, a nebulized therapy for COPD, sharing profits at a ratio of 35% for Theravance and 65% for Viatris [9][10] - In Q1 2025, Theravance reported $15.4 million in collaboration revenues from Yupelri sales, reflecting a year-over-year increase of 6.2% [11] Pipeline Development - Theravance is developing ampreloxetine, a norepinephrine reuptake inhibitor for treating symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA) [11] - The phase III CYPRESS study for ampreloxetine is expected to complete patient enrollment by late summer, with top-line data anticipated six months post-enrollment [12]

Financial Data and Key Metrics Changes - The total YUPELRI business has shown strong growth, particularly in the hospital channel, recovering well post-COVID pandemic [2][3] - The company has been able to slightly increase pricing, stabilizing it after previous disruptions [12] Business Line Data and Key Metrics Changes - The hospital business for YUPELRI has been growing unit volume at a faster rate, driven by formulary wins and increased sales representative collaboration with Viatris [4][5] - The company is still in the early stages of growth for YUPELRI, indicating significant potential for future expansion [9] Market Data and Key Metrics Changes - The entry of ensifentrine has not significantly impacted the market share of YUPELRI, as it is generally added to existing therapies rather than replacing them [10][11] - The company is focused on optimizing the channel to improve net pricing and overall fulfillment processes [12] Company Strategy and Development Direction - The company is prioritizing the growth of YUPELRI in the hospital setting before considering adding new products to the sales force [14][15] - Ampreloxetine is viewed as a critical asset for future growth, with a focus on efficient commercialization strategies [30][32] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the long-term potential of YUPELRI and Trelegy, highlighting the challenges of replicating Trelegy's success [33][35] - The company is committed to returning excess capital to shareholders while focusing on the success of YUPELRI and the development of ampreloxetine [38] Other Important Information - The company has a strong cash position with $130 million on the balance sheet and potential milestones from Trelegy and YUPELRI [31] - The development of Ampreloxetine is seen as a unique opportunity to address a significant unmet need in treating MSA patients [19][24] Q&A Session Summary Question: Are you losing patients at the initial script fill or during refills? - Management indicated that they lose patients both at the initial fill and during follow-up with regional pulmonologists [8] Question: How is the enrollment for the Ampreloxetine study progressing? - Management emphasized the importance of selecting the right patients and sites for the study, ensuring quality care throughout the process [26][27] Question: What is the long-term outlook for Trelegy and its royalties? - Management believes that Trelegy will continue to perform well in both asthma and COPD markets, with royalties reverting back to the company in 2029 [35]

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements (unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) Unaudited Q1 2025 financial statements detail a net loss and a significant increase in cash from a milestone payment Key Financial Highlights (Q1 2025 vs Q1 2024) | Metric | Q1 2025 ($ thousands) | Q1 2024 ($ thousands) | | :--- | :--- | :--- | | Total Revenues | 15,388 | 14,503 | | Loss from Operations | (14,434) | (11,207) | | Net Loss | (13,579) | (11,664) | | Net Loss per Share | (0.27) | (0.24) | | Cash from Operating Activities | 43,039 | (1,022) | - Total assets decreased slightly to **$343.6 million** as of March 31, 2025, from **$354.2 million** at year-end 2024, while cash and cash equivalents significantly increased to **$110.6 million** from **$37.8 million**, primarily due to a **$50.0 million** milestone payment from Royalty Pharma[8](index=8&type=chunk)[40](index=40&type=chunk) - The company confirms it has sufficient cash, cash equivalents, and marketable securities to fund its operations for at least the next twelve months from the filing date[18](index=18&type=chunk) [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The March 31, 2025 balance sheet highlights total assets of $343.6 million and a notable increase in cash and cash equivalents Balance Sheet Summary (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $110,614 | $37,797 | | Total current assets | $150,264 | $161,067 | | Total assets | $343,582 | $354,161 | | Total current liabilities | $31,502 | $32,085 | | Total shareholders' equity | $165,983 | $175,545 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Q1 2025 statements of operations report total revenues of $15.4 million and a net loss of $13.6 million Q1 2025 vs Q1 2024 Statement of Operations (in thousands) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Total Revenues | $15,388 | $14,503 | | Research and development | $11,452 | $8,968 | | Selling, general and administrative | $18,370 | $16,742 | | Loss from operations | $(14,434) | $(11,207) | | Net loss | $(13,579) | $(11,664) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Q1 2025 cash flow statements show net cash provided by operating activities of $43.0 million, significantly boosted by a $50.0 million milestone payment Cash Flow Summary (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $43,039 | $(1,022) | | Net cash provided by investing activities | $30,632 | $17,028 | | Net cash used in financing activities | $(854) | $(1,716) | | Net increase in cash, cash equivalents, and restricted cash | $72,817 | $14,290 | - The positive operating cash flow was mainly due to the collection of a **$50.0 million** receivable related to milestones and royalty assets[13](index=13&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes to financial statements detail accounting policies, Viatris collaboration revenue, a $50.0 million milestone, and YUPELRI patent litigation - Revenue of **$15.4 million** is derived from the Viatris collaboration agreement for YUPELRI, under which the company receives **35%** of the profit/loss from US commercialization[29](index=29&type=chunk)[34](index=34&type=chunk)[35](index=35&type=chunk) - In February 2025, the company received a **$50.0 million** milestone payment from Royalty Pharma related to 2024 TRELEGY global net sales, with a remaining future contingent milestone and royalty asset of **$144.2 million**[51](index=51&type=chunk)[52](index=52&type=chunk) - The company is in patent infringement litigation against several generic companies regarding YUPELRI, with settlements granting five companies a license to launch a generic version on April 23, 2039, while litigation against three others remains pending[73](index=73&type=chunk)[75](index=75&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2025 financial condition and results, noting YUPELRI sales growth, increased R&D and SG&A expenses, and sufficient liquidity - The company's focus is on its commercial product **YUPELRI®** for COPD and its late-stage investigational drug, **ampreloxetine**, for symptomatic neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA)[80](index=80&type=chunk) - A **$50.0 million** milestone payment related to TRELEGY sales was received from Royalty Pharma in February 2025, with an additional **$150.0 million** in potential milestone payments remaining[99](index=99&type=chunk)[100](index=100&type=chunk) Key Expense Changes (Q1 2025 vs Q1 2024) | Expense Category | Q1 2025 ($ thousands) | Q1 2024 ($ thousands) | % Change | Primary Driver | | :--- | :--- | :--- | :--- | :--- | | Research & Development | $11,452 | $8,968 | 28% | Ampreloxetine Phase 3 study costs | | Selling, General & Administrative | $18,370 | $16,742 | 10% | Ampreloxetine pre-launch activities | - As of March 31, 2025, the company had approximately **$130.9 million** in cash, cash equivalents, and marketable securities, with no long-term debt, and expects this to be sufficient to fund operations for at least the next twelve months[123](index=123&type=chunk)[125](index=125&type=chunk) [Management Overview](index=28&type=section&id=Management%20Overview) This overview details the company's core programs, YUPELRI and ampreloxetine, including collaboration terms and economic interests in TRELEGY - **YUPELRI** (revefenacin) is co-promoted with Viatris in the US under a **35%** (Theravance) / **65%** (Viatris) profit and loss sharing arrangement[84](index=84&type=chunk) - **Ampreloxetine** is in a Phase 3 study (CYPRESS) for MSA patients with symptomatic nOH, with top-line data anticipated approximately six months after final patient enrollment by late summer 2025[96](index=96&type=chunk) - The company retains a mid- and long-term economic interest in **TRELEGY**, including up to **$150.0 million** in remaining potential milestone payments from Royalty Pharma and **85%** of royalties in outer years (post-2029/2031)[98](index=98&type=chunk)[100](index=100&type=chunk)[104](index=104&type=chunk) [Results of Operations](index=37&type=section&id=Results%20of%20Operations) This section details Q1 2025 financial performance, noting a 6% revenue increase, a 28% rise in R&D expenses, and a 10% increase in SG&A expenses YUPELRI Net Sales (in thousands) | Metric | Q1 2025 | Q1 2024 | % Change | | :--- | :--- | :--- | :--- | | YUPELRI net sales (100% recorded by Viatris) | $58,344 | $55,226 | 6% | | YUPELRI net sales (Theravance Biopharma implied 35%) | $20,420 | $19,329 | 6% | - The increase in YUPELRI sales was driven by a **5%** rise in customer demand and a **48%** increase in doses through the hospital channel compared to the prior year[112](index=112&type=chunk) - R&D expenses increased by **$2.5 million** (**28%**) YoY, mainly due to a **$2.2 million** increase in external costs for the ampreloxetine CYPRESS study and related NDA activities[115](index=115&type=chunk) - SG&A expenses increased by **$1.6 million** (**10%**) YoY, primarily due to a **$1.2 million** increase in pre-launch medical/commercial expenses for ampreloxetine and a **$0.3 million** increase in G&A costs for the ongoing strategic review[117](index=117&type=chunk)[118](index=118&type=chunk) [Liquidity and Capital Resources](index=41&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company held $130.9 million in cash and marketable securities, with sufficient liquidity for the next twelve months - The company had **$130.9 million** in cash, cash equivalents, and marketable securities as of March 31, 2025, and no long-term debt[123](index=123&type=chunk) - Management believes existing cash resources are sufficient to fund operations for at least the next twelve months[125](index=125&type=chunk) Cash Flow Summary (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $43,039 | $(1,022) | | Net cash provided by investing activities | $30,632 | $17,028 | | Net cash used in financing activities | $(854) | $(1,716) | [Quantitative and Qualitative Disclosures About Market Risk](index=43&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a "smaller reporting company," the company is not required to provide quantitative and qualitative disclosures about market risk - As a "smaller reporting company," the company is not required to provide quantitative and qualitative disclosures about market risk[134](index=134&type=chunk) [Controls and Procedures](index=43&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal controls - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of March 31, 2025[135](index=135&type=chunk) - No changes in internal control over financial reporting occurred during Q1 2025 that materially affected, or are reasonably likely to materially affect, internal controls[138](index=138&type=chunk) [PART II. OTHER INFORMATION](index=45&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=45&type=section&id=Item%201.%20Legal%20Proceedings) This section details ongoing patent infringement litigation concerning YUPELRI, including FDA stays and settlements with some generic companies for a 2039 launch - The company is engaged in patent infringement lawsuits against multiple generic companies that filed ANDAs for a generic version of YUPELRI[139](index=139&type=chunk) - The lawsuits have triggered an FDA stay, preventing approval of the generic ANDAs through May 2026, pending court decisions[139](index=139&type=chunk) - Settlements have been reached with five generic companies (Accord, Lupin, Orbicular, Qilu, and Teva), allowing for a licensed generic launch on April 23, 2039, while litigation against three other generic companies remains pending[141](index=141&type=chunk) [Risk Factors](index=47&type=section&id=Item%201A.%20Risk%20Factors) This section outlines principal risks, including net losses, reliance on YUPELRI, ampreloxetine development uncertainties, generic competition, and strategic review outcomes - The company has a history of net losses, including **$13.6 million** in Q1 2025, and may never achieve or sustain profitability from operations[147](index=147&type=chunk) - The company's business is highly dependent on the continued commercial success of **YUPELRI**, which faces competition and pricing pressures, and on its collaboration with Viatris[153](index=153&type=chunk)[162](index=162&type=chunk) - There are significant risks associated with the development of **ampreloxetine**, including the potential for the Phase 3 CYPRESS study to be delayed, fail to meet its endpoints, or not receive regulatory approval[155](index=155&type=chunk)[158](index=158&type=chunk) - The company faces patent litigation from generic companies seeking to market a version of **YUPELRI**, which could result in earlier-than-expected generic competition[187](index=187&type=chunk)[241](index=241&type=chunk) - The ongoing strategic review process, announced in November 2024, may be distracting, costly, and may not result in a transaction, which could adversely affect the business and shareholder value[169](index=169&type=chunk)[170](index=170&type=chunk)[171](index=171&type=chunk) [Exhibits](index=110&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the 10-Q report, including CEO and CFO certifications and financial statements in iXBRL format - The exhibits include certifications from the Chief Executive Officer and Chief Financial Officer as required by SEC rules (Exhibits 31.1, 31.2, and 32)[316](index=316&type=chunk) - The financial statements and notes are provided in iXBRL format (Exhibit 101), and the cover page interactive data file is also included (Exhibit 104)[316](index=316&type=chunk)

Core Viewpoint - Theravance Biopharma reported a wider-than-expected adjusted net loss for Q1 2025, indicating ongoing financial challenges despite a year-over-year revenue increase driven by collaboration revenues from Viatris [1][2]. Financial Performance - The adjusted net loss for Q1 2025 was 17 cents per share, compared to a loss of 11 cents estimated by Zacks Consensus, and a loss of 9 cents in the same quarter last year [1]. - Total revenues for the first quarter were $15.4 million, missing the Zacks Consensus Estimate of $16 million, but representing a 6.2% increase year-over-year due to higher collaboration revenues from Viatris [2]. - The reported loss, including share-based compensation and other expenses, was 27 cents per share, compared to a loss of 24 cents in the prior year [2]. Collaboration and Revenue Sources - Revenues were entirely derived from Viatris' collaboration related to Yupelri (revefenacin) sales, which is used for chronic obstructive pulmonary disease treatment [4]. - Viatris recorded $58.3 million in U.S. net sales of Yupelri for Q1 2025, reflecting a 6% year-over-year increase [6]. - Theravance receives 35% of the profits from Yupelri sales, while Viatris retains 65% [5]. Expenses and Financial Guidance - Research and development expenses (excluding share-based compensation) were $10.4 million, up 40.5% from the previous year, while selling, general, and administrative expenses increased by 13.2% to $14.6 million [10]. - Theravance reaffirmed its financial guidance for 2025, expecting adjusted R&D expenses between $32 million and $38 million, and SG&A expenses between $50 million and $60 million [11]. Pipeline Developments - Theravance is developing ampreloxetine, a norepinephrine reuptake inhibitor for treating symptomatic neurogenic orthostatic hypotension in patients with multiple system atrophy [12]. - The phase III CYPRESS study for ampreloxetine is expected to complete patient enrollment by late summer, with top-line data anticipated six months post-enrollment [13].

Core Insights - Theravance Biopharma presented analyses of its Phase 3 program for ampreloxetine, targeting symptomatic neurogenic orthostatic hypotension (nOH) at the International MSA Congress in Boston [1][2] Company Overview - Theravance Biopharma focuses on developing innovative therapies, including ampreloxetine, a selective norepinephrine reuptake inhibitor for treating nOH in patients with multiple system atrophy (MSA) [6][13] - 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 [6] Clinical Study Findings - A subgroup analysis from the REDWOOD 0170 study indicated that MSA patients had the highest nOH symptom burden, emphasizing the need for improved therapies [2] - Results from the studies support the ongoing registrational study (CYPRESS) evaluating ampreloxetine's efficacy in MSA patients [3] - Patients with MSA showed clinically meaningful improvement in nOH symptoms after 16 weeks of treatment with ampreloxetine, with stable symptoms in the treatment group compared to worsening in the placebo group [7][10] Study Details - The CYPRESS study is a Phase 3, multi-center, randomized withdrawal trial assessing ampreloxetine's efficacy after 20 weeks of treatment, with primary endpoints focused on changes in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score [9] - The REDWOOD 0170 study included a 16-week open-label period followed by a 6-week double-blind, placebo-controlled withdrawal period, with a primary endpoint of treatment failure defined by specific worsening scores [10] Patient Impact - MSA patients experience severe symptoms affecting their quality of life due to nOH, with 70-90% of MSA patients experiencing these symptoms [11] - The clinical profile of ampreloxetine demonstrated target engagement and sustained blood pressure effects, indicating its potential as a first-in-class therapy for MSA-related nOH [6][7]