Core Viewpoint - Momentum investing focuses on following a stock's recent price trends, aiming to buy high and sell higher, with the expectation that established trends will continue [1] Company Overview: Theravance Biopharma (TBPH) - Theravance Biopharma currently holds a Momentum Style Score of A, indicating strong momentum characteristics [3] - The company has a Zacks Rank of 2 (Buy), suggesting a favorable outlook based on historical performance metrics [4] Performance Metrics - TBPH shares have increased by 9.85% over the past week, outperforming the Zacks Medical - Drugs industry, which rose by 4.47% during the same period [6] - Over the past month, TBPH's price change is 25.76%, significantly higher than the industry's 0.88% [6] - In the last quarter, TBPH shares rose by 29.72%, and over the past year, they have gained 87.75%, while the S&P 500 increased by only 6.25% and 14.29%, respectively [7] Trading Volume - TBPH's average 20-day trading volume is 594,234 shares, which serves as a bullish indicator when combined with rising stock prices [8] Earnings Outlook - In the last two months, 2 earnings estimates for TBPH have been revised upwards, while only 1 estimate was revised downwards, leading to an increase in the consensus estimate from -$0.06 to $0.24 [10] - For the next fiscal year, 3 estimates have moved upwards with no downward revisions, indicating positive sentiment regarding future earnings [10] Conclusion - Given the strong momentum indicators and positive earnings outlook, TBPH is positioned as a promising investment opportunity with a Momentum Score of A and a Zacks Rank of 2 (Buy) [12]

Theravance Biopharma Conference Call Summary Company Overview - **Company**: Theravance Biopharma - **Focus**: Development of Ampraloxetine for treating neurogenic orthostatic hypotension (NOH) in patients with multiple system atrophy (MSA) [2][4][5] Industry Context - **Target Disease**: Neurogenic orthostatic hypotension (NOH) associated with multiple system atrophy (MSA) - **Patient Population**: Approximately 40,000 MSA patients in the U.S. with NOH [6][44] - **Current Treatment Landscape**: Existing therapies (midodrine, droxidopa) provide only transient relief and are not effective for MSA [46][47] Key Points and Arguments Ampraloxetine Development - **Phase 3 Study**: The pivotal CYPRESS study is nearing completion, with data expected in Q1 2026 [2][5] - **Mechanism of Action**: Ampraloxetine is a selective norepinephrine transporter (NET) inhibitor designed to enhance norepinephrine levels, thereby improving blood pressure and symptoms in NOH patients [31][19] - **Clinical Evidence**: Previous studies indicated that 70% of MSA patients remain symptomatic despite current treatments, highlighting the unmet need [18][46] Financial Position - **Cash Reserves**: Theravance ended the last quarter with $333 million in cash and no debt, achieving cash flow break-even [5] - **Milestones**: Expected near-term milestones of $175 million from existing products (Trelegy and Yupelri) [5] Clinical Trial Insights - **CYPRESS Study Design**: The study incorporates lessons from the previous REDWOOD study, focusing on a randomized withdrawal design to assess treatment effects [32][34] - **Primary Endpoint**: The Orthostatic Hypotension Symptom Assessment (OHSA) composite score is selected as the primary endpoint, reflecting the full spectrum of NOH symptoms [34][38] Market Opportunity - **Commercial Strategy**: Targeting a concentrated patient population with a lean commercial infrastructure, focusing on centers of excellence [44][51] - **Physician Sentiment**: High interest from physicians, with 90% of neurologists likely to prescribe Ampraloxetine if approved [48] - **Pricing Expectations**: Anticipated pricing aligns with other rare disease therapies, potentially around $300,000 annually per patient [57] Regulatory Engagement - **FDA Interactions**: Positive feedback from the FDA regarding the study design and primary endpoint, indicating alignment for a potential NDA submission [38][42] Additional Important Insights - **Safety Profile**: Ampraloxetine has shown an acceptable safety profile with low side effects and no worsening of supine hypertension [40] - **Global Market Potential**: Opportunities exist beyond the U.S. in Europe and Asia, with established relationships in key opinion leader networks [58] Conclusion - **Future Outlook**: If CYPRESS data is positive, Ampraloxetine could become the first tailored treatment for NOH in MSA, addressing a significant unmet medical need and establishing a new standard of care [60]

Financial Status & Milestones - Theravance Biopharma had approximately $333 million in cash with no debt and expects to remain at similar levels in Q4 2025 [7] - The company anticipates $175 million in near-term milestones based on TRELEGY and YUPELRI sales [7] - Theravance Biopharma has a 35% U S profit share with Viatris for YUPELRI, with IP protection into 2039 [7] Ampreloxetine & CYPRESS Trial - Ampreloxetine targets approximately 40,000 underserved patients in the U S with symptomatic nOH due to MSA [7] - The Phase 3 CYPRESS trial completed enrollment in Q3 2025, with topline data expected in Q1 2026 [7] - In a REDWOOD pre-specified MSA subgroup analysis (n=40), the greatest difference was observed in the 6-item OHSA composite score [48, 51] - Approximately 70-80% of patients with MSA will develop nOH in their lifetime, and despite treatment with available pressor agents, 68% remain symptomatic [30] Commercial Opportunity - The U S market includes approximately 40,000 MSA patients with nOH [7, 83, 96] - Only approximately 34% of patients are currently treated, indicating a significant unmet need [84] - The average launch price for chronic neurology therapies is approximately $333,000 [111]

Core Viewpoint - Theravance Biopharma (TBPH) has seen a 25.8% increase in share price over the past four weeks, closing at $18.7, with a mean price target of $24.43 indicating a potential upside of 30.6% [1] Price Targets and Analyst Estimates - The mean estimate consists of seven short-term price targets with a standard deviation of $8.85, where the lowest estimate is $13.00 (indicating a 30.5% decline) and the highest is $40.00 (indicating a 113.9% increase) [2] - A low standard deviation suggests a strong agreement among analysts regarding the stock's price movement [2][9] Earnings Estimates and Analyst Agreement - Analysts show strong agreement in revising TBPH's earnings estimates higher, which is a positive indicator for potential stock upside [4][11] - Over the last 30 days, the Zacks Consensus Estimate for the current year has increased by 69.6%, with two estimates moving higher and one lower [12] Zacks Rank and Investment Potential - TBPH holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [13] - The consensus price target may not be a reliable indicator of potential gains, but the implied direction of price movement appears to be a useful guide [14]

分组1 - Zacks Premium offers various tools for investors to enhance their stock market engagement and confidence, including daily updates, research reports, and stock screens [1][2] - The Zacks Style Scores are complementary indicators that rate stocks based on value, growth, and momentum methodologies, helping investors identify stocks likely to outperform the market in the short term [3][4] 分组2 - The Value Score focuses on identifying undervalued stocks using financial ratios such as P/E and Price/Sales, appealing to value investors [4] - The Growth Score assesses a company's future prospects through projected earnings and sales, targeting growth investors [5] - The Momentum Score evaluates price trends and earnings outlook changes to assist momentum investors in timing their purchases [6] 分组3 - The VGM Score combines all three Style Scores, providing a comprehensive rating that highlights stocks with attractive value, strong growth forecasts, and promising momentum [7] - The Zacks Rank is a proprietary model that utilizes earnings estimate revisions to guide investors in building successful portfolios [8][9] 分组4 - Stocks rated 1 (Strong Buy) have historically produced an average annual return of +23.93% since 1988, significantly outperforming the S&P 500 [9] - To maximize returns, investors should focus on stocks with a Zacks Rank of 1 or 2 and Style Scores of A or B [10] 分组5 - Theravance Biopharma (TBPH) is a biopharmaceutical company focused on respiratory medicines, currently rated 2 (Buy) with a VGM Score of A [12] - TBPH is projected to achieve year-over-year earnings growth of 175% for the current fiscal year, with upward revisions in earnings estimates [13]

Summary of Theravance Biopharma FY Conference Call Company Overview - **Company**: Theravance Biopharma (NasdaqGM:TBPH) - **Key Product**: Yupelri, generating approximately $50 million annually in operating cash [4][27] - **Financial Position**: The company has no debt and has cleaned up its balance sheet, positioning itself well for upcoming developments [4][34] Key Focus Areas - **Phase 3 Cypress Study**: The primary focus is on the Cypress study, which is expected to read out in Q1 2026. This study is pivotal for the approval of ampraloxetine for treating neurogenic orthostatic hypotension (nOH) in multiple system atrophy (MSA) patients [4][5][20] - **Previous Studies**: The Redwood study indicated a strong signal in MSA patients, leading to the design of Cypress as an MSA-only study [6][7] Clinical Data and Efficacy - **Redwood Study Results**: The Redwood study showed a 1.6-point change in the OHSA composite score, indicating a clinically meaningful improvement in symptoms associated with nOH [9][10] - **Cypress Study Goals**: The Cypress study aims for at least a one-point change in the composite score, which is considered clinically meaningful [9][10] - **Symptom Improvement**: The Redwood study showed consistent improvement across various symptoms, including dizziness and weakness, which are expected to be replicated in the Cypress study [11][12] Regulatory and Commercial Strategy - **NDA Preparation**: The NDA for ampraloxetine is largely complete, pending positive results from the Cypress study. The company has conducted extensive safety and efficacy evaluations [14][16] - **Payer Discussions**: Initial discussions with payers have been positive, emphasizing the rarity of the condition and the lack of existing chronic treatments [23][24] Yupelri Insights - **Market Strategy**: Theravance co-promotes Yupelri with Viatris, focusing on hospital formularies and ensuring patients are discharged with prescriptions [27][28] - **Patient Retention**: The company is working to improve patient retention on Yupelri through better first-fill processes and partnerships with specialty pharmacies [29][30] - **Clinical Benefits**: Yupelri has shown comparable or superior benefits in managing COPD exacerbations compared to leading competitors [32] Financial Outlook - **Cash Position**: Theravance has a strong financial foundation with $330 million in cash and an additional $175 million in near-term milestones expected over the next 15 months [33][34] - **Investment Potential**: The combination of financial strength, successful commercialization experience, and potential positive outcomes from the Cypress study positions Theravance favorably for future growth [34] Additional Considerations - **Unique Market Position**: The company aims to establish a new standard of care for MSA patients with chronic treatment options, which are currently lacking in the market [20][21] - **KOL Engagement**: A key opinion leader event is scheduled for December 8, 2025, to further discuss commercial strategies and the potential impact of ampraloxetine [24]

Core Viewpoint - Theravance Biopharma is hosting a virtual key opinion leader investor event to discuss the unmet medical need for symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA) and the potential of ampreloxetine as a treatment option [1][2][3] Company Overview - Theravance Biopharma focuses on delivering innovative medicines, including the investigational drug ampreloxetine, which is in development for treating symptomatic nOH in MSA patients [9] - The company has previously developed the FDA-approved YUPELRI (revefenacin) inhalation solution for chronic obstructive pulmonary disease (COPD) [9] Event Details - The investor event is scheduled for December 8, 2025, featuring Dr. Horacio Kaufmann from NYU Langone Health, who will discuss the medical need for nOH treatment in MSA patients and review ampreloxetine's potential [1][2] - The event will also provide an overview of the ongoing Phase 3 CYPRESS study of ampreloxetine, including strategic design choices based on positive results from the REDWOOD study [3] Drug Information - Ampreloxetine is a once-daily selective norepinephrine reuptake inhibitor, showing benefits such as increased norepinephrine levels and improved blood pressure in MSA patients [5] - The drug has received Orphan Drug Designation in the U.S. for treating symptomatic nOH in MSA patients, with plans for a New Drug Application (NDA) submission pending supportive results from the CYPRESS study [5] Study Overview - The CYPRESS study (Study 0197) is a Phase 3, multi-center, randomized withdrawal study evaluating the efficacy and durability of ampreloxetine in MSA patients with symptomatic nOH [6] - The primary endpoint is the change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score after 20 weeks of treatment [6] Disease Context - Multiple system atrophy (MSA) is a progressive brain disorder affecting movement and balance, with approximately 50,000 patients in the U.S., of whom 70-90% experience nOH symptoms [7] - Neurogenic orthostatic hypotension (nOH) is characterized by a significant drop in blood pressure upon standing, leading to debilitating symptoms such as dizziness and fainting [8]

Core Insights - Theravance Biopharma, Inc. will participate in two investor conferences in December 2025, focusing on healthcare and rare diseases [1][2] Group 1: Upcoming Events - The company will present at the 8th Annual Evercore Healthcare Conference on December 4, 2025, in a fireside chat format from 8:20 to 8:40 AM ET [1] - Theravance will also participate in the Oppenheimer Movers in Rare Disease Summit on December 11, 2025, with a panel discussion scheduled from 2:15 to 2:45 PM ET [1] - One-on-one meetings will be available for interested investors during both events [1] Group 2: Company Overview - Theravance Biopharma focuses on delivering impactful medicines, leveraging decades of expertise [3] - The company has developed YUPELRI (revefenacin), an FDA-approved inhalation solution for chronic obstructive pulmonary disease (COPD) [3] - Ampreloxetine, a late-stage investigational drug for neurogenic orthostatic hypotension in patients with Multiple System Atrophy, is being developed as a potential first-in-class therapy [3]

Sales Performance - YUPELRI (revefenacin) inhalation solution generated US net sales of $71.4 million in Q3 2025, a 15% increase from $62.2 million in Q3 2024[100]. - YUPELRI net sales for the three months ended September 30, 2025, were $71.4 million, a 15% increase year-over-year, and for the nine months, net sales were $196.0 million, also a 14% increase[122]. - Total revenues for the nine months ended September 30, 2025, were $61.6 million, a 35% increase compared to the prior year, driven by higher net sales of YUPELRI[125]. - TRELEGY global net sales for 2024 reached $3.46 billion, representing a 26% increase compared to 2023, and are expected to peak at approximately $4.0 billion in 2026[113]. - For the three months ended September 30, 2025, TRELEGY global net sales were $979 million, reflecting a 24% year-over-year growth, while for the nine months, sales were $2.92 billion, showing a 13% increase[113]. Milestone Payments and Royalties - The company is eligible to receive up to $205 million in potential global sales and regulatory milestone payments from Viatris, with $160 million associated with YUPELRI monotherapy[96]. - To achieve a $25 million sales milestone for YUPELRI in 2025, approximately $54 million in US net sales is required in Q4 2025[97]. - Viatris' Phase 3 study of YUPELRI in China yielded positive results, leading to regulatory approval and a $7.5 million milestone payment to the company[98]. - As of September 30, 2025, YUPELRI's cumulative net sales in the China Region could trigger additional sales milestones of up to $37.5 million[99]. - As of September 30, 2025, a total of $150.0 million in potential Milestone Payments remain available, with eligibility for $25.0 million or $50.0 million based on TRELEGY global net sales thresholds of approximately $3.06 billion and $3.41 billion, respectively[111]. - The company received a maximum $50 million milestone payment from Royalty Pharma in February 2025, based on achieving a minimum royalty amount from TRELEGY's global net sales of $3.46 billion in 2024[110]. - The company is eligible for tiered royalties on net sales of nebulized revefenacin in the China Region, with rates ranging from 14% to 20% based on sales thresholds[100]. Research and Development - Ampreloxetine is in a Phase 3 clinical study, with top-line data expected in Q1 2026, following positive results from earlier studies[106]. - Royalty Pharma invested $40 million in ampreloxetine, including a $25 million upfront payment and a $15 million payment upon the first regulatory approval[107]. Expenses and Financial Management - R&D expenses for the three months ended September 30, 2025, decreased by 12% to $8.1 million, primarily due to a reduction in external-related expenses[127]. - SG&A expenses for the three months ended September 30, 2025, were $18.3 million, a 9% increase compared to the prior year, with total SG&A expenses for the nine months at $55.1 million[131]. - Year-to-date G&A expenses (excluding SBC) increased by $2.7 million, primarily due to one-time legal costs; excluding these costs, G&A expenses were 3% lower compared to the prior year[134]. - Total SBC related to SG&A expenses was $3.5 million and $10.9 million for the three and nine months ended September 30, 2025, respectively, compared to $3.9 million and $11.8 million for the same periods in 2024[135]. - No impairment charges for long-lived assets were recognized for the three and nine months ended September 30, 2025, compared to non-cash impairment charges of $1.6 million and $4.5 million in the prior year[137]. Income and Cash Flow - A net gain of $75.1 million on realized contingent milestone and royalty assets was recognized for the nine months ended September 30, 2025, resulting from the sale of TRELEGY royalties to GSK[138]. - Interest expense for the three and nine months ended September 30, 2025, was $0.6 million and $1.9 million, respectively, representing non-cash interest expense associated with a $25.0 million funding received in July 2022[140]. - Interest and other income, net, increased by $2.7 million and $2.6 million for the three and nine months ended September 30, 2025, respectively, primarily due to increased interest income from cash and marketable securities[141]. - The provision for income tax expense for the nine months ended September 30, 2025, was $11.3 million, primarily due to the net gain on realized contingent milestone and royalty assets[144]. - As of September 30, 2025, the company had approximately $332.7 million in cash, cash equivalents, and investments in marketable securities, with no long-term debt[145]. - Net cash provided by operating activities was $244.6 million for the nine months ended September 30, 2025, driven by a net income of $44.9 million and significant cash inflows from milestone payments[149]. - Net cash used in investing activities was $105.9 million for the nine months ended September 30, 2025, primarily from the purchase and maturities of marketable securities[151]. Strategic Focus - The company remains focused on disciplined capital allocation and evaluating strategic alternatives to enhance shareholder value, as initiated by the Strategic Review Committee[115].

Core Insights - Theravance Biopharma (TBPH) reported third-quarter 2025 adjusted earnings of 4 cents per share, exceeding the Zacks Consensus Estimate of a loss of 3 cents, and improved from an adjusted loss of 6 cents per share in the same quarter last year [1][6] - Total revenues for the third quarter reached $20 million, aligning with the Zacks Consensus Estimate, and reflecting a 19% year-over-year increase driven by collaboration revenues from partner Viatris (VTRS) [1][6] Financial Performance - The revenue for the quarter was solely derived from Viatris' collaboration revenues related to Yupelri (revefenacin) sales [3] - U.S. sales of Yupelri increased by 15% year over year, contributing to the positive financial results [6] - Viatris recorded $71.4 million in U.S. net sales of Yupelri for the third quarter, marking a 15% increase from the previous year [7] Expense Management - Research and development expenses (excluding share-based compensation) totaled $7 million, a decrease of approximately 14.6% from the year-ago quarter [7] - Selling, general and administrative expenses (excluding share-based compensation) rose around 13.8% year over year to $14.8 million [7] Cash Position - As of September 30, 2025, Theravance had cash, cash equivalents, and marketable securities amounting to $332.7 million, down from $338.8 million as of June 30, 2025 [8] Financial Guidance - Theravance reaffirmed its financial guidance for 2025, expecting adjusted R&D expenses (excluding share-based compensation) in the range of $32-$38 million and adjusted SG&A expenses between $50 million and $60 million [9] - The company anticipates share-based compensation expenses of $18-$20 million in 2025 [9] Pipeline Developments - Theravance is developing ampreloxetine, a norepinephrine reuptake inhibitor for treating symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA) [11] - The pivotal phase III CYPRESS study for ampreloxetine has completed enrollment, with top-line data expected in the first quarter of 2026 [11] - An expedited new drug application (NDA) filing for ampreloxetine is planned if the study data are positive, with a request for priority review from the FDA [12]