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]

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 Insights - CorMedix (CRMD) and Theravance Biopharma (TBPH) are small-cap biotechnology companies with market caps under $1 billion, operating in niche therapeutic markets and characterized by limited product portfolios and high volatility potential for investors [1][5] CorMedix (CRMD) - CorMedix's lead product, DefenCath, received FDA approval in late 2023 as the first antimicrobial catheter lock solution in the U.S., aimed at reducing catheter-related bloodstream infections in adult patients undergoing hemodialysis [2] - DefenCath generated $78.8 million in net revenues in the first half of 2025, with expectations for strong year-over-year growth in the third quarter [7] - The company plans to expand DefenCath's label into total parenteral nutrition, enhancing its customer base [8] - CorMedix acquired Melinta Therapeutics for $300 million, adding seven approved therapies to its portfolio and diversifying its revenue streams [9] - Preliminary third-quarter 2025 results showed net revenues exceeding $125 million, prompting an increase in full-year revenue guidance to at least $375 million [12] - The Zacks Consensus Estimate for CorMedix's 2025 sales and EPS indicates year-over-year increases of approximately 488% and 717%, respectively [19] Theravance Biopharma (TBPH) - Theravance collaborates with Viatris to commercialize Yupelri, a nebulized treatment for COPD, sharing profits with Viatris receiving 65% and Theravance 35% [13] - Revenues from the Viatris collaboration rose 19% year-over-year to $34.1 million in the first half of 2025 [15] - Theravance is developing ampreloxetine for neurogenic orthostatic hypotension, with top-line data expected in Q1 2026 [16] - The company sold its remaining royalty interest in Trelegy Ellipta to GSK for $225 million, strengthening its balance sheet [17] - The Zacks Consensus Estimate for Theravance's 2025 sales implies an 88% year-over-year increase, with a projected 75% narrowing of loss per share [19] Comparative Analysis - CorMedix's strategy focuses on immediate revenue generation through DefenCath, while Theravance relies on a partnership for revenue and is dependent on the success of its late-stage drug program [4][31] - CorMedix's diversified portfolio and strong commercial execution position it favorably compared to Theravance, which faces higher risks due to its limited pipeline and reliance on a single collaboration [31] - Year-to-date, CRMD shares have gained 39.6%, while TBPH shares have increased by 50.5%, outperforming the industry average of 10.7% [24]

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]

Core Insights - Viatris Inc. reported second-quarter 2025 adjusted earnings of 62 cents per share, exceeding the Zacks Consensus Estimate of 56 cents, but down from 69 cents per share in the same quarter last year [1][7] - Total revenues for the quarter were $3.58 billion, a decrease of 6% year over year, yet surpassing the Zacks Consensus Estimate of $3.5 billion [1][5] - The company's share price has declined 29.7% year to date, compared to an 8.6% decline in the industry [2] Revenue Breakdown - Sales from Developed Markets were $2.11 billion, down 4% on a divestiture-adjusted operational basis, but above the Zacks Consensus Estimate of $2.01 billion [5] - Emerging Markets generated sales of $555.1 million, up 1% on a divestiture-adjusted operational basis, beating the Zacks Consensus Estimate of $542 million [6] - Sales from Japan, Australia, and New Zealand (JANZ) totaled $305.7 million, down 11% on a divestiture-adjusted operational basis, missing the Zacks Consensus Estimate of $310 million [6] - Greater China sales reached $588.9 million, up 9% on a divestiture-adjusted operational basis, exceeding the Zacks Consensus Estimate of $546 million [6] Product Category Performance - Revenues from Brands decreased 3% to $2.3 billion, but increased 3% on a divestiture-adjusted operational basis, driven by strong performance in Greater China and Emerging Markets [7] - Lipitor sales rose to $388 million, Norvasc sales increased to $182.7 million, and Lyrica sales grew to $128.1 million compared to the previous year [8] - Generics revenues were $1.28 billion, down 10%, with a 9% decline on an operational change basis, attributed to the negative impact from the Indore facility [9] Financial Metrics - Adjusted gross margin was 56.3%, down from 58.4% in the prior year [11] - The company has returned over $630 million to shareholders in the year to date, including more than $350 million in share repurchases [11] - Viatris expects total share repurchases of $500 million to $650 million in 2025 [11] Guidance and Updates - The company reaffirmed its 2025 revenue guidance of $13.5 billion to $14 billion and raised its adjusted earnings per share forecast to a range of $2.16 to $2.30 [12] - Positive top-line results were announced from phase III studies evaluating MR-142 and MR-141 for treating vision impairments [13] - A phase III study for MR-139 did not meet its primary endpoint [14]

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 - Viatris Inc. (VTRS) reported better-than-expected first-quarter adjusted earnings of 50 cents per share, surpassing the Zacks Consensus Estimate of 49 cents, although down from 67 cents per share in the same quarter last year [1][15] Financial Performance - Total revenues for the quarter were $3.25 billion, reflecting an 11% year-over-year decline, but still exceeding the Zacks Consensus Estimate of $3.23 billion [1][15] - Adjusted gross margin decreased to 55.9% from 58.8% year-over-year [10] Sales Breakdown - Sales from Developed Markets were $1.9 billion, down 3% on a divestiture-adjusted operational basis, missing the Zacks Consensus Estimate of $1.93 billion [4] - Emerging Markets generated $519.9 million in sales, down 5% on a divestiture-adjusted operational basis, but beating the Zacks Consensus Estimate of $464 million [5] - Sales from Japan, Australia, and New Zealand (JANZ) totaled $276.1 million, down 6% and missing the Zacks Consensus Estimate of $309 million [5] - Greater China sales increased by 4% to $555.5 million, surpassing the Zacks Consensus Estimate of $553 million [5] Product Category Performance - Revenues from Brands decreased by 8% to $2.1 billion, but increased by 3% on a divestiture-adjusted operational basis [6] - Lipitor sales were $388 million, relatively flat year-over-year, while Norvasc and Lyrica sales declined [6] - Generics revenue was $1.1 billion, down 16%, with an operational decline of 11% [7][9] Future Guidance - Viatris maintains its total revenue guidance for 2025 at $13.5-$14 billion and adjusted earnings per share guidance at $2.16-$2.30, updated from a previous range of $2.12-$2.26 [12] Research and Development Updates - Positive results were reported from phase III studies for Effexor and a novel formulation of meloxicam, with plans to submit a new drug application to the FDA by the end of 2025 [13][14]