Group 1 - B. Riley Securities analyst Mayank Mamtani initiated coverage on Theravance Biopharma, Inc. (TBPH) with a Buy rating and a price target of $28, while shares closed at $13.70 [3] - Leerink Partners analyst Faisal Khurshid initiated coverage on Protagonist Therapeutics, Inc. (PTGX) with an Outperform rating and a price target of $73, with shares closing at $59.68 [3] - Barclays analyst David Strauss initiated coverage on StandardAero, Inc. (SARO) with an Overweight rating and a price target of $32, while shares closed at $27.35 [3]

Company Overview - Theravance Biopharma's shares have increased by approximately 9.8% since the last earnings report, outperforming the S&P 500 [1] - The company reported a narrower than expected adjusted net loss of 8 cents per share for Q2 2025, compared to the Zacks Consensus Estimate of a loss of 14 cents [3] - Total revenues for Q2 2025 reached $26.2 million, significantly exceeding the Zacks Consensus Estimate of $17 million, and representing an 83.2% year-over-year increase [4] Revenue Breakdown - The revenue growth was driven by increased collaboration revenues from partner Viatris and licensing revenues [4] - Collaboration revenues from Viatris related to Yupelri sales amounted to $18.7 million, reflecting a 31% year-over-year increase [5] - Theravance received a milestone payment of $7.5 million from Viatris following the approval of Yupelri in China [5] Expense Analysis - Research and development expenses (excluding share-based compensation) totaled $9.5 million, an increase of nearly 8% from the previous year [6] - Selling, general and administrative expenses (excluding share-based compensation) rose approximately 16.4% year-over-year to $12.8 million [6] - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities worth $338.8 million, up from $130.9 million as of March 31, 2025 [6] Financial Guidance - Theravance reaffirmed its financial guidance for 2025, expecting adjusted R&D expenses in the range of $32-$38 million and adjusted SG&A expenses between $50 million and $60 million [7] - The company anticipates share-based compensation expenses of $18-$20 million in 2025 and expects adjusted losses and cash burn to be similar to 2024 levels [7] Market Sentiment - There has been a positive trend in fresh estimates, with the consensus estimate shifting by 36.84% recently [8] - Theravance holds a Growth Score of A but has a lower Momentum Score of C, with an overall VGM Score of A [10] - The stock has a Zacks Rank of 3 (Hold), indicating an expectation of an in-line return in the coming months [11] Industry Comparison - Theravance operates within the Zacks Medical - Drugs industry, where another player, United Therapeutics, has seen a 28% gain over the past month [12] - United Therapeutics reported revenues of $798.6 million for the last quarter, reflecting an 11.7% year-over-year increase, with an EPS of $6.41 compared to $5.85 a year ago [12]

Theravance Biopharma Conference Call Summary Company Overview - **Company**: Theravance Biopharma (NasdaqGM:TBPH) - **Key Products**: Ampreloxetine, YUPELRI - **Financial Position**: Over $300 million in cash, no debt, $175 million in near-term milestones expected with high probability of receipt [2][2] Core Product Insights Ampreloxetine - **Target Indication**: Rare neurological condition, multiple system atrophy (MSA) with neurogenic orthostatic hypotension (NOH) - **Patient Population**: Approximately 40,000 patients in the U.S. with MSA and NOH, with 66% to 75% experiencing significant symptoms [2][15] - **Clinical Development**: Phase 3 study completed enrollment; data expected in Q1 2026 [1][2] - **Mechanism of Action**: Addresses autonomic failure by improving blood pressure regulation, enabling patients to ambulate and improve quality of life [5][11] - **Market Opportunity**: Claims analysis suggests about 50,000 MSA patients in the U.S., with 80% having NOH [16][15] YUPELRI - **Current Performance**: Continued growth with a 22% increase in net sales year-over-year; $40 to $50 million in free cash flow annually [28][28] - **Market Strategy**: Focus on transitioning care from hospital to home, maximizing patient persistence on therapy [27][29] - **International Expansion**: Recently approved in China, with a passive interest from Theravance; expected launch likely in 2026 [30][30] Competitive Landscape - **Current Treatments**: Existing options like droxidopa and midodrine have limitations in efficacy and duration; ampreloxetine aims to provide a more durable solution [20][20] - **Regulatory Considerations**: Ampreloxetine does not have the same safety concerns (e.g., supine hypertension) as existing treatments [25][20] Commercial Strategy - **Pre-launch Activities**: Direct management of the CYPRESS study to build relationships with physicians and understand market needs [13][14] - **Resource Allocation**: Focused and deliberate capital investment strategy for the launch of ampreloxetine, contingent on successful data readout [24][24] - **Sales Approach**: Tailored strategies for rare disease markets, emphasizing close relationships with treatment centers [18][19] Financial Outlook - **Break-even Status**: The company is nearing cash flow break-even, with expectations to maintain this through data readout [28][28] - **Investment Strategy**: Future capital commitments will be made only when confident in regulatory success and market readiness [24][24] Additional Insights - **Patient Support**: Emphasis on providing comprehensive support for patients, including medical, pharmacologic, and access components [18][18] - **Market Research**: Ongoing efforts to refine understanding of the MSA NOH market to optimize resource allocation [19][19]

Company Announcement - Theravance Biopharma, Inc. will participate in the H.C. Wainwright 27th Annual Global Investment Conference in New York City on September 9, 2025 [1] - CEO Rick Winningham will engage in a Fireside Chat during the event at 1:30 PM EDT [1] Investor Engagement - Management will host in-person meetings during the conference, and interested investors are encouraged to contact their H.C. Wainwright representative for meeting requests [1] Company Overview - Theravance Biopharma focuses on delivering impactful medicines, with FDA-approved YUPELRI® for chronic obstructive pulmonary disease (COPD) [3] - The company is developing Ampreloxetine, a late-stage investigational therapy for neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA), which has the potential to be a first-in-class treatment [3] - Theravance Biopharma is committed to creating and driving shareholder value [3]

Core Insights - Theravance Biopharma has completed enrollment in the pivotal Phase 3 CYPRESS study for ampreloxetine, targeting symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA) [1][3][5] - nOH affects approximately 80% of MSA patients, leading to severe symptoms and a lack of effective treatment options [1][8] - The CYPRESS study aims to evaluate the efficacy and safety of ampreloxetine, with topline data expected in Q1 2026 [3][5] Company Overview - Theravance Biopharma focuses on developing innovative therapies, including ampreloxetine, a selective norepinephrine reuptake inhibitor for nOH in MSA patients [4][9] - The company has received Orphan Drug Designation for ampreloxetine in the U.S., highlighting the unmet medical need in this patient population [5][9] Study Details - The CYPRESS study is a global, randomized-withdrawal trial assessing ampreloxetine's impact on nOH symptoms, with a primary endpoint of change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score [2][6] - The study includes a 12-week open-label phase followed by an 8-week randomized withdrawal phase [2][6] Market Context - There are approximately 40,000 patients in the U.S. suffering from symptomatic nOH due to MSA, indicating a significant market opportunity for effective treatments [2][5] - Current therapies for nOH often fail to provide lasting relief and have safety concerns, underscoring the need for new solutions like ampreloxetine [2][3]

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section presents the unaudited condensed consolidated financial statements and notes for the periods ended June 30, 2025, and 2024 [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20as%20of%20June%2030%2C%202025%20and%20December%2031%2C%202024) Condensed Consolidated Balance Sheets | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | Change (in thousands) | | :-------------------------------- | :----------------------------- | :------------------------------- | :-------------------- | | Cash and cash equivalents | $281,927 | $37,797 | +$244,130 | | Total current assets | $366,294 | $161,067 | +$205,227 | | Total assets | $426,035 | $354,161 | +$71,874 | | Total current liabilities | $54,633 | $32,085 | +$22,548 | | Total shareholders' equity | $224,848 | $175,545 | +$49,303 | [Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20(Loss)%20for%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202025%20and%202024) Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) | Metric | 3 Months Ended June 30, 2025 (in thousands) | 3 Months Ended June 30, 2024 (in thousands) | Change (in thousands) | 6 Months Ended June 30, 2025 (in thousands) | 6 Months Ended June 30, 2024 (in thousands) | Change (in thousands) | | :------------------------------------------ | :---------------------------------------- | :---------------------------------------- | :-------------------- | :---------------------------------------- | :---------------------------------------- | :-------------------- | | Total revenues | $26,195 | $14,256 | +$11,939 | $41,583 | $28,759 | +$12,824 | | Research and development | $10,490 | $9,954 | +$536 | $21,942 | $18,922 | +$3,020 | | Selling, general and administrative | $18,430 | $17,056 | +$1,374 | $36,800 | $33,798 | +$3,002 | | Loss from operations | $(2,725) | $(15,705) | +$12,980 | $(17,159) | $(26,912) | +$9,753 | | Net gain on realized contingent milestone and royalty assets | $75,137 | $0 | +$75,137 | $75,137 | $0 | +$75,137 | | Net income (loss) | $54,835 | $(16,529) | +$71,364 | $41,256 | $(28,193) | +$69,449 | | Net income (loss) per share - basic | $1.09 | $(0.34) | +$1.43 | $0.83 | $(0.58) | +$1.41 | [Condensed Consolidated Statements of Shareholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Shareholders'%20Equity%20for%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202025%20and%202024) Condensed Consolidated Statements of Shareholders' Equity | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | Change (in thousands) | | :-------------------------------- | :----------------------------- | :------------------------------- | :-------------------- | | Total shareholders' equity | $224,848 | $175,545 | +$49,303 | | Additional paid-in capital | $1,149,123 | $1,141,060 | +$8,063 | | Accumulated deficit | $(924,266) | $(965,522) | +$41,256 | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20six%20months%20ended%20June%2030%2C%202025%20and%202024) Condensed Consolidated Statements of Cash Flows | Metric | 6 Months Ended June 30, 2025 (in thousands) | 6 Months Ended June 30, 2024 (in thousands) | Change (in thousands) | | :------------------------------------------ | :---------------------------------------- | :---------------------------------------- | :-------------------- | | Net cash provided by (used in) operating activities | $251,113 | $(5,437) | +$256,550 | | Net cash provided by (used in) investing activities | $(5,626) | $13,997 | $(19,623) | | Net cash used in financing activities | $(1,357) | $(1,760) | +$403 | | Net increase in cash, cash equivalents, and restricted cash | $244,130 | $6,800 | +$237,330 | | Cash, cash equivalents, and restricted cash at end of period | $282,763 | $47,181 | +$235,582 | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Details significant accounting policies, revenue recognition, segment information, and key financial events impacting the statements - The company is a biopharmaceutical company focused on developing and commercializing medicines[12](index=12&type=chunk) - The accounting policy for "Future Contingent Milestone and Royalty Assets" was revised, now accounted for under ASC Topic 450, Contingencies, with subsequent gains recognized using gain contingency guidance and impairments using loss contingency guidance[17](index=17&type=chunk)[20](index=20&type=chunk) - The Contingent Consideration asset was fully settled through the Royalty Sales Agreement, assigning TRELEGY royalties to GSK, and recognized under the gain contingency model[21](index=21&type=chunk) - The company expects its cash, cash equivalents, and marketable securities to be **sufficient to fund operations for at least the next twelve months**[16](index=16&type=chunk) - YUPELRI received regulatory approval by China's NMPA in June 2025, triggering a **$7.5 million licensing revenue milestone** from Viatris[29](index=29&type=chunk) - The company co-promotes YUPELRI in the US under a **35% profit and loss sharing arrangement** with Viatris[30](index=30&type=chunk) - The company operates in a **single segment**: development and commercialization of human therapeutics[39](index=39&type=chunk) - Increase in cash and cash equivalents primarily due to **$225.0 million from TRELEGY royalties sale** (June 2025) and **$50.0 million milestone payment** from Royalty Pharma (February 2025)[43](index=43&type=chunk) - Contingent liability for ampreloxetine funding from Royalty Pharma was **$31.640 million** as of June 30, 2025, with an imputed effective interest rate of approximately **8.3%**[51](index=51&type=chunk)[54](index=54&type=chunk) - A contract derivative, recognized within non-current other assets, increased in fair value to **$2.365 million** as of June 30, 2025, driven by a decrease in the estimated discount rate to **5.0%**[57](index=57&type=chunk) - The company retained the right to receive remaining potential **$150.0 million in Milestone Payments** from Royalty Pharma for TRELEGY global net sales in 2025 and 2026[62](index=62&type=chunk) - Sublease income is recognized as a reduction to rent expense within selling, general and administrative expenses[64](index=64&type=chunk) - Income tax expense of **$17.8 million** for the six months ended June 30, 2025, primarily due to the net gain on realized contingent milestone and royalty assets from the TRELEGY royalties sale[72](index=72&type=chunk)[136](index=136&type=chunk) - The company did not accrue any estimated losses related to its ongoing legal proceedings as of June 30, 2025[78](index=78&type=chunk) Key Financial Metrics from Notes | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :------------------------------------------ | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Net income (loss) per share - basic | $1.09 | $(0.34) | $0.83 | $(0.58) | | Net income (loss) per share - diluted | $1.08 | $(0.34) | $0.81 | $(0.58) | | Viatris collaboration agreement revenue | $18,695 | $14,256 | $34,083 | $28,759 | | Licensing revenue | $7,500 | $0 | $7,500 | $0 | | Total share-based compensation expense | $4,543 | $5,376 | $9,420 | $10,604 | | Sublease income | $2,447 | $2,204 | $4,751 | $4,294 | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Provides management's perspective on financial performance, operational updates, liquidity, and future outlook [Forward-Looking Statements](index=31&type=section&id=Forward-Looking%20Statements) - Forward-looking statements involve risks, uncertainties, and assumptions, and actual results may differ materially from expectations[84](index=84&type=chunk) - The company does not assume any obligation to update forward-looking statements[84](index=84&type=chunk) [Management Overview](index=33&type=section&id=Management%20Overview) - Theravance Biopharma is a biopharmaceutical company focused on developing and commercializing medicines[85](index=85&type=chunk) - Key programs include **YUPELRI®** (revefenacin) inhalation solution for COPD and **ampreloxetine** for symptomatic neurogenic orthostatic hypotension (nOH) in Multiple System Atrophy (MSA) patients[86](index=86&type=chunk) [Core Program Updates](index=33&type=section&id=Core%20Program%20Updates) Updates on YUPELRI's China approval, ampreloxetine's Phase 3 study, and the sale of TRELEGY royalties to GSK - YUPELRI (revefenacin) inhalation solution is a once-daily, nebulized LAMA approved for maintenance treatment of COPD in the US[87](index=87&type=chunk) - China's NMPA approved YUPELRI on June 26, 2025, triggering a **$7.5 million milestone payment** from Viatris[90](index=90&type=chunk)[91](index=91&type=chunk) - Ampreloxetine is an investigational, wholly-owned NRI for symptomatic nOH in MSA patients, currently in a **Phase 3 CYPRESS study**[94](index=94&type=chunk)[100](index=100&type=chunk) - Previous Phase 3 studies (SEQUOIA and REDWOOD) for ampreloxetine did not meet primary endpoints for the overall population but **showed benefit in MSA patients**[98](index=98&type=chunk)[99](index=99&type=chunk) - FDA granted **Orphan Drug Designation status** to ampreloxetine for symptomatic nOH in MSA in May 2023[100](index=100&type=chunk) - The company sold its remaining royalty interest in TRELEGY to GSK for a one-time upfront payment of **$225.0 million** on June 2, 2025[109](index=109&type=chunk) - Retained the right to receive potential remaining **$150.0 million in Milestone Payments** from Royalty Pharma based on TRELEGY global net sales in 2025 and 2026[109](index=109&type=chunk) - Received a **$50.0 million Milestone Payment** from Royalty Pharma in February 2025 for achieving 2024 TRELEGY global net sales thresholds ($3.46 billion)[103](index=103&type=chunk) YUPELRI US Net Sales Milestones | YUPELRI US Net Sales (in a Calendar Year) | Sales Milestones Due from Viatris | | :---------------------------------------- | :-------------------------------- | | $250.0 million | $25.0 million | | $500.0 million | $50.0 million | | $750.0 million | $75.0 million | YUPELRI China Region Net Sales Milestones | YUPELRI China Region Net Sales (Cumulative) | Sales Milestones Due from Viatris | | :---------------------------------------- | :-------------------------------- | | $100.0 million | $2.5 million | | $200.0 million | $5.0 million | | $400.0 million | $10.0 million | | $800.0 million | $20.0 million | YUPELRI China Region Royalty Rates | YUPELRI China Region Net Sales Thresholds (Annual) | Royalty Rate Due from Viatris | | :---------------------------------------- | :---------------------------- | | ≤ $75.0 million | 14% | | > $75.0 million to ≤ $150.0 million | 17% | | > $150.0 million | 20% | TRELEGY Global Net Sales Royalty Rates | TRELEGY Global Net Sales Thresholds (Annual) | Royalty Rate Due from GSK to Royalty Pharma | | :---------------------------------------- | :---------------------------------------- | | ≤ $750.0 million | 6.5% | | > $750.0 million to ≤ $1,250.0 million | 8.0% | | > $1,250.0 million to ≤ $2,250.0 million | 9.0% | | > $2,250.0 million | 10.0% | [Critical Accounting Policies and Estimates](index=41&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) - Financial statements are prepared in accordance with US GAAP, requiring management estimates and assumptions[115](index=115&type=chunk) - No material changes to critical accounting policies and estimates since the Annual Report on Form 10-K for the year ended December 31, 2024[116](index=116&type=chunk) [Results of Operations](index=41&type=section&id=Results%20of%20Operations) Analyzes revenue growth and a shift to net income driven by the TRELEGY royalty sale and increased YUPELRI sales Results of Operations Summary | Metric | 3 Months Ended June 30, 2025 (in thousands) | 3 Months Ended June 30, 2024 (in thousands) | Change ($) | Change (%) | 6 Months Ended June 30, 2025 (in thousands) | 6 Months Ended June 30, 2024 (in thousands) | Change ($) | Change (%) | | :------------------------------------------ | :---------------------------------------- | :---------------------------------------- | :--------- | :--------- | :---------------------------------------- | :---------------------------------------- | :--------- | :--------- | | Total revenues | $26,195 | $14,256 | $11,939 | 84% | $41,583 | $28,759 | $12,824 | 45% | | Total research & development | $10,490 | $9,954 | $536 | 5% | $21,942 | $18,922 | $3,020 | 16% | | Selling, general and administrative | $18,430 | $17,056 | $1,374 | 8% | $36,800 | $33,798 | $3,002 | 9% | | Impairment of long-lived assets (non-cash) | $0 | $2,951 | $(2,951) | NM | $0 | $2,951 | $(2,951) | NM | | Net gain on realized contingent milestone and royalty assets | $75,137 | $0 | $75,137 | NM | $75,137 | $0 | $75,137 | NM | | Interest expense (non-cash) | $(663) | $(644) | $(19) | 3% | $(1,306) | $(1,273) | $(33) | 3% | | Interest and other income, net | $1,457 | $1,128 | $329 | 29% | $2,396 | $2,562 | $(166) | (6)% | | Provision for income tax expense | $(18,371) | $(1,308) | $(17,063) | 1,305% | $(17,812) | $(2,570) | $(15,242) | 593% | - Total revenues increased due to higher YUPELRI net sales and a **$7.5 million licensing revenue** from China's NMPA approval[118](index=118&type=chunk)[120](index=120&type=chunk)[121](index=121&type=chunk) - R&D expenses increased due to the CYPRESS study and ampreloxetine regulatory activities, partially offset by decreased share-based compensation[122](index=122&type=chunk)[123](index=123&type=chunk) - SG&A expenses increased due to one-time legal costs and pre-launch medical affairs and commercialization expenses for ampreloxetine[127](index=127&type=chunk)[128](index=128&type=chunk) - The **$75.1 million net gain** on contingent milestone and royalty assets resulted from the sale of TRELEGY royalties to GSK[131](index=131&type=chunk) [Liquidity and Capital Resources](index=47&type=section&id=Liquidity%20and%20Capital%20Resources) Details the company's strong liquidity position, cash flow changes, and capital resources as of June 30, 2025 - As of June 30, 2025, the company had approximately **$338.8 million in cash, cash equivalents, and marketable securities** (excluding restricted cash) and no long-term debt[137](index=137&type=chunk) - Cash resources are expected to be **sufficient to fund operations for at least the next twelve months**[139](index=139&type=chunk) - Liquidity was significantly boosted by a **$50.0 million milestone** from Royalty Pharma (February 2025) and **$225.0 million** from GSK for the Royalty Sales Agreement (June 2025)[137](index=137&type=chunk) - The company indemnifies officers and directors and maintains insurance, believing the fair value of these indemnification agreements is minimal, and no liabilities were recognized as of June 30, 2025[147](index=147&type=chunk) Cash Flow Summary | Metric | 6 Months Ended June 30, 2025 (in thousands) | 6 Months Ended June 30, 2024 (in thousands) | Change (in thousands) | | :------------------------------------------ | :---------------------------------------- | :---------------------------------------- | :-------------------- | | Net cash provided by (used in) operating activities | $251,113 | $(5,437) | +$256,550 | | Net cash provided by (used in) investing activities | $(5,626) | $13,997 | $(19,623) | | Net cash used in financing activities | $(1,357) | $(1,760) | +$403 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=49&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a "smaller reporting company," Theravance Biopharma is not required to provide quantitative and qualitative disclosures about market risk - The company is a "smaller reporting company" and is not required to provide this information[148](index=148&type=chunk) [Item 4. Controls and Procedures](index=49&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details the company's evaluation of disclosure controls and procedures, concluding their effectiveness, while also acknowledging the inherent limitations of control systems [Evaluation of Disclosure Controls and Procedures](index=49&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) - CEO and CFO concluded that disclosure controls and procedures were **effective at the reasonable assurance level** as of June 30, 2025[149](index=149&type=chunk) [Limitations on the Effectiveness of Controls](index=49&type=section&id=Limitations%20on%20the%20Effectiveness%20of%20Controls) - Control systems provide only **reasonable, not absolute, assurance** that objectives are met[150](index=150&type=chunk) - Inherent limitations mean not all control issues or fraud instances may be detected[150](index=150&type=chunk) [Changes in Internal Control over Financial Reporting](index=51&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) - **No material changes** in internal control over financial reporting were identified during Q2 2025[151](index=151&type=chunk) [PART II. OTHER INFORMATION](index=51&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=51&type=section&id=Item%201.%20Legal%20Proceedings) This section details the company's ongoing patent infringement lawsuits related to YUPELRI against generic drug manufacturers [Litigation – Patent Infringement](index=51&type=section&id=Litigation%20%E2%80%93%20Patent%20Infringement) - In January 2023, generic companies filed ANDAs for YUPELRI, leading to patent infringement suits by the company[152](index=152&type=chunk) - A **stay of approval through May 2026** was imposed by the FDA on generic ANDAs[152](index=152&type=chunk) - As of July 31, 2025, litigation with several generic companies settled, granting royalty-free licenses to launch generic YUPELRI in the US on or after **April 23, 2039**[154](index=154&type=chunk) - Patent litigation against two remaining generic companies and affiliates is pending[154](index=154&type=chunk) [Item 1A. Risk Factors](index=53&type=section&id=Item%201A.%20Risk%20Factors) This section outlines various risks that could materially and adversely affect the company's business, financial condition, and operating results [Summary of Principal Risks Associated with Theravance Biopharma's Business](index=53&type=section&id=Summary%20of%20Principal%20Risks%20Associated%20with%20Theravance%20Biopharma's%20Business) - Risks include inability to achieve or sustain profitability, YUPELRI market acceptance issues, delays in clinical studies, failure to obtain regulatory approvals, partner non-compliance, substantial competition, extensive regulation, and generic competition for YUPELRI[158](index=158&type=chunk) [RISKS RELATING TO THE COMPANY](index=55&type=section&id=RISKS%20RELATING%20TO%20THE%20COMPANY) - The company may **never achieve or sustain profitability** from operations, despite recent net income driven by a one-time gain from TRELEGY royalties sale[159](index=159&type=chunk) - Commercial success of YUPELRI depends on continued acceptance by physicians, patients, and payors, and faces competition from short-acting nebulized bronchodilators and new therapies[162](index=162&type=chunk)[165](index=165&type=chunk)[188](index=188&type=chunk) - Clinical studies for product candidates are expensive, lengthy, and may face delays or adverse results, as seen with izencitinib and previous ampreloxetine studies[167](index=167&type=chunk)[171](index=171&type=chunk) - Regulatory approval for product candidates like ampreloxetine is complex and uncertain, requiring extensive data and potentially additional testing[172](index=172&type=chunk)[175](index=175&type=chunk) - Dependence on partners like Viatris for YUPELRI commercialization and potential future partners for other candidates carries risks of non-fulfillment or termination of agreements[177](index=177&type=chunk)[178](index=178&type=chunk) - The sale of TRELEGY royalties means future Milestone Payments depend on GSK's commercialization ability and TRELEGY sales, with **no control over the program**[211](index=211&type=chunk)[212](index=212&type=chunk) - The ongoing Strategic Review Committee process may be time-consuming, disruptive, and may not result in additional transactions or value for shareholders[184](index=184&type=chunk) - Reliance on **single-source third-party manufacturers** for API and drug products for YUPELRI and product candidates poses supply chain risks[189](index=189&type=chunk)[192](index=192&type=chunk) [RISKS RELATED TO LEGAL AND REGULATORY UNCERTAINTY](index=86&type=section&id=RISKS%20RELATED%20TO%20LEGAL%20AND%20REGULATORY%20UNCERTAINTY) - Reliance on patents, trade secrets, and confidentiality agreements to protect intellectual property, with risks of challenges, invalidation, or misappropriation[252](index=252&type=chunk)[253](index=253&type=chunk) - Ongoing patent infringement litigation for YUPELRI against generic companies, with settlements granting licenses for generic launch in **April 2039** for some, but litigation pending for others[256](index=256&type=chunk) - Product liability lawsuits are inherent in pharmaceutical development and commercialization, potentially leading to substantial liabilities, reputational harm, and diversion of resources[258](index=258&type=chunk)[262](index=262&type=chunk) - Subject to complex and evolving data protection laws (e.g., CCPA, GDPR), with risks of government enforcement actions, private litigation, and significant compliance costs for non-compliance or data breaches[263](index=263&type=chunk)[267](index=267&type=chunk)[268](index=268&type=chunk)[269](index=269&type=chunk) - Healthcare law changes, government restrictions on pricing and reimbursement (e.g., IRA, state laws), and cost-containment initiatives may negatively impact revenues and profitability[272](index=272&type=chunk)[280](index=280&type=chunk)[281](index=281&type=chunk) - Compliance with anti-kickback, fraud and abuse, and transparency laws (e.g., Anti-Kickback Statute, False Claims Act, Physician Payment Sunshine Act) is critical, with potential for significant penalties, fines, and exclusion from government programs for violations[296](index=296&type=chunk)[298](index=298&type=chunk)[299](index=299&type=chunk) [RISKS RELATING TO OUR ORDINARY SHARES](index=105&type=section&id=RISKS%20RELATING%20TO%20OUR%20ORDINARY%20SHARES) - Market price for ordinary shares has fluctuated widely and may continue to do so, influenced by low trading volumes and concentrated ownership[303](index=303&type=chunk)[305](index=305&type=chunk)[306](index=306&type=chunk) - Activist shareholders could negatively impact business by diverting management attention and resources, causing operational disruptions, and increasing share price volatility[308](index=308&type=chunk)[310](index=310&type=chunk) - Concentration of ownership (**three largest shareholders collectively owned 43.1%** as of June 30, 2025) limits other shareholders' ability to influence corporate matters[312](index=312&type=chunk) - Certain constitutional provisions and a potential shareholder rights plan may discourage third-party acquisition, limiting opportunities to sell shares at a premium[313](index=313&type=chunk)[314](index=314&type=chunk) - Shareholders may face difficulties protecting their interests due to **Cayman Islands incorporation**, which has different shareholder rights and fiduciary responsibilities compared to US jurisdictions[315](index=315&type=chunk)[316](index=316&type=chunk) - The company is a "smaller reporting company," which allows for reduced reporting and disclosure requirements, potentially making ordinary shares less attractive to some investors[326](index=326&type=chunk)[328](index=328&type=chunk) [Item 6. Exhibits](index=115&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including key agreements, certifications, and financial statements in iXBRL format - Exhibit 2.1: Assignment Agreement, dated May 30, 2025, between Theravance Biopharma, Inc. and GlaxoSmithKline Intellectual Property Development Limited[330](index=330&type=chunk) - Exhibit 31.1 and 31.2: Certifications of Chief Executive Officer and Chief Financial Officer[330](index=330&type=chunk) - Exhibit 32: Certifications of CEO and CFO pursuant to 18 U.S.C. Section 1350[330](index=330&type=chunk) - Exhibit 101: Financial statements in iXBRL format[330](index=330&type=chunk) [Signatures](index=116&type=section&id=Signatures) This section contains the official signatures of the company's Chief Executive Officer and Chief Financial Officer, certifying the report's submission - Report signed by Rick E Winningham, CEO, and Aziz Sawaf, SVP & CFO, on August 13, 2025[334](index=334&type=chunk)

Core Insights - Theravance Biopharma (TBPH) reported a narrower adjusted net loss of 8 cents per share for Q2 2025, compared to the expected loss of 14 cents and a loss of 13 cents in the same quarter last year [1][7] - Total revenues for Q2 reached $26.2 million, exceeding the Zacks Consensus Estimate of $17 million, and reflecting an 83.2% year-over-year increase driven by collaboration and licensing revenues [2][7] - Year-to-date, Theravance's shares have increased by 26.6%, outperforming the industry average rise of 5.3% [2] Financial Performance - Revenues from the collaboration with Viatris related to Yupelri sales amounted to $18.7 million, marking a 31% increase year-over-year [8] - Viatris reported U.S. net sales of Yupelri at $66.3 million for Q2, a 22% increase year-over-year, indicating strong demand growth [5][7] - The company received a milestone payment of $7.5 million from Viatris following Yupelri's approval in China [8] Expenses and Financial Guidance - Research and development expenses (excluding share-based compensation) totaled $9.5 million, an increase of nearly 8% from the previous year [9] - Selling, general, and administrative expenses (excluding share-based compensation) rose approximately 16.4% year-over-year to $12.8 million [9] - 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 [10] Pipeline and Strategic Updates - Theravance is developing ampreloxetine, a norepinephrine reuptake inhibitor for treating symptomatic neurogenic orthostatic hypotension in patients with multiple system atrophy [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] - Theravance sold its remaining royalty interest in Trelegy Ellipta to GSK for $225 million, marking a strategic move to maximize shareholder value [13]

分组1 - Theravance Biopharma reported a quarterly loss of $0.08 per share, better than the Zacks Consensus Estimate of a loss of $0.14, representing an earnings surprise of +42.86% [1] - The company posted revenues of $26.2 million for the quarter ended June 2025, exceeding the Zacks Consensus Estimate by 53.76%, compared to $14.26 million in the same quarter last year [2] - Theravance Bio shares have increased by approximately 21.2% since the beginning of the year, outperforming the S&P 500's gain of 8.4% [3] 分组2 - The current consensus EPS estimate for the upcoming quarter is -$0.09 on revenues of $18.12 million, and for the current fiscal year, it is $0.01 on revenues of $96.03 million [7] - The Medical - Drugs industry, to which Theravance Bio belongs, is currently ranked in the top 35% of over 250 Zacks industries, indicating a favorable outlook [8]

Financial Data and Key Metrics Changes - The company reported net sales for YUPELRI of approximately $66 million for the quarter, representing a 22% year-over-year increase, marking the highest Q2 results since launch [4][8] - Collaboration revenue grew by 31% year-over-year, driven by YUPELRI's net sales growth, leading to improved brand-level profit margins [22][24] - Non-GAAP losses improved to $4.2 million compared to $6.3 million in the prior year, excluding one-time items [25] Business Line Data and Key Metrics Changes - YUPELRI's hospital channel volume increased by 31% compared to 2024, with a long-acting nebulized market share in hospitals reaching approximately 20% [10][11] - The company completed the $225 million sale of its remaining royalty interest in Trelegy to GSK, significantly strengthening its balance sheet [4][22] - Ampreloxetine's Phase 3 Cyprus trial is nearing completion of enrollment, with expectations to report top-line data approximately six months after [5][28] Market Data and Key Metrics Changes - YUPELRI received approval in China, triggering a $7.5 million milestone payment, with plans for commercialization led by Beatrice [4][11] - GSK reported an all-time high of $1.1 billion in Trelegy sales for Q2, contributing to a year-to-date sales total of approximately $2 billion, an 8% increase year-over-year [22] Company Strategy and Development Direction - The company is focused on enhancing shareholder value through strategic reviews and disciplined capital management [6][28] - Ampreloxetine is positioned as a potential transformative therapy for patients with multiple system atrophy (MSA), with a targeted addressable population of approximately 40,000 patients in the U.S. [21][28] - The company aims to maintain a strong financial position while preparing for the upcoming data readout from the Cyprus study [28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the $250 million sales threshold for YUPELRI, which would trigger a $25 million milestone payment [9][10] - The company anticipates a stronger second half of the year compared to previous expectations, creating a solid financial foundation as it approaches the Cyprus data readout [26][28] - Management highlighted the importance of the upcoming Cyprus trial results, which could redefine the standard of care for patients with MSA [28] Other Important Information - The company ended the quarter with approximately $340 million in cash and no debt, indicating strong cash management [6][25] - The company is preparing for NDA readiness in parallel with the Cyprus study, with modules already in advanced stages of drafting [19] Q&A Session Summary Question: What contributed to the improved pull-through for YUPELRI this quarter? - Management attributed the improved pull-through to the shift of volume to specialty pharmacy, which enhances patient support and fulfillment [32][35] Question: What is the outlook for YUPELRI in China and the enrollment trends for Cyprus? - Management noted that Beatrice will lead the commercialization in China, and the enrollment profile for Cyprus is expected to be similar to previous studies [41][42] Question: How will pricing for Ampreloxetine be determined? - Management indicated that while it is early to finalize pricing, analysis of recent rare neuro drug launches suggests an average price around $380,000 per year [47] Question: What are the expectations for SG&A increases associated with Ampreloxetine? - Management expects SG&A to remain stable through the second half of the year, with potential increases post-data readout if results are positive [54][56]

YUPELRI Performance and Growth - YUPELRI net sales reached $663 million in Q2 2025, a 22% increase compared to Q2 2024[8, 19] - Excluding a one-time favorable price adjustment, YUPELRI sales still experienced mid-teens growth[19] - Hospital doses of YUPELRI grew by 31% compared to Q2 2024, achieving a new market share high of 204%[8, 19] - The YUPELRI approval in China triggered a $75 million milestone payment and potential tiered royalties of 14-20%[8, 19] Ampreloxetine Development - Enrollment in the pivotal Phase 3 CYPRESS study for Ampreloxetine is expected to be completed in late summer, with topline data anticipated approximately 6 months later[8] - Ampreloxetine targets approximately 40000 underserved patients with symptomatic nOH due to MSA[61] TRELEGY Milestones and Financials - Q2 2025 net sales of TRELEGY were approximately $11 billion, and year-to-date net sales reached approximately $20 billion, up 8% year-over-year[8, 40] - The company completed the sale of TRELEGY royalty interest for $225 million[8] - Theravance Biopharma is on pace to achieve $150 million in TRELEGY sales milestones in 2025 and 2026[40] Financial Highlights - Viatris collaboration revenue was $187 million in Q2 2025, a 31% increase year-over-year[47, 52] - Licensing revenue was $75 million in Q2 2025, driven by the YUPELRI China approval milestone[47, 52] - The company's cash and cash equivalents totaled $3388 million as of the end of Q2 2025, including the $225 million cash receipt from the TRELEGY royalty sale[52] - Non-GAAP net loss for Q2 2025 was $42 million[47, 52]