Core Insights - Theravance Biopharma reported strong third-quarter results, achieving record net sales for YUPELRI and reaching non-GAAP breakeven, indicating financial and operational discipline [2][4][11] - The company is advancing ampreloxetine towards pivotal Phase 3 CYPRESS study topline results expected in Q1 2026, with a focus on addressing unmet needs in multiple system atrophy patients [2][3][15] Operational Highlights - YUPELRI net sales reached an all-time high of $71.4 million, a 15% increase year-over-year, driven by a 6% growth in customer demand and improved net pricing [4][5] - The open-label portion of the pivotal Phase 3 CYPRESS study for ampreloxetine is complete, with topline results anticipated in Q1 2026 [4][11] - The company plans to host a virtual Key Opinion Leader event on December 8, 2025, to discuss ampreloxetine's potential in treating neurogenic orthostatic hypotension [5][11] Financial Performance - Total revenue for Q3 2025 was $20.0 million, with Viatris collaboration revenue increasing by 19% compared to Q3 2024 [11][31] - R&D expenses for Q3 2025 were $8.1 million, down from $9.3 million in the same period in 2024, while SG&A expenses rose to $18.3 million from $16.9 million [11][31] - Net income for Q3 2025 was $3.6 million, a significant improvement from a net loss of $12.7 million in Q3 2024, aided by a $6.5 million income tax benefit [11][33] Strategic Initiatives - The company is preparing for an expedited NDA submission for ampreloxetine, contingent on supportive data from the ongoing study [5][15] - Theravance Biopharma continues to focus on disciplined capital allocation and returning excess cash to shareholders, with a Strategic Review Committee assessing strategic alternatives [18][20]

点击查看更多企业ESG评级。 据新浪财经ESG评级中心，2025年10月30日，Theravance Biopharma Inc. - Ordinary Shares（TBPH.US） MSCI（明晟）ESG评级由BBB调升至A。 来源：ESG评级中心 ...

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]

Core Viewpoint - Theravance Biopharma is set to present its clinical development program for ampreloxetine, a potential treatment for neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA), at the upcoming International Symposium on the Autonomic Nervous System [1][2]. Company Presentations - The company will have one platform presentation and three poster presentations at the symposium, focusing on the efficacy and methodologies related to ampreloxetine [1][2]. - The platform presentation will highlight results from the REDWOOD trial, showcasing durable symptomatic benefits of ampreloxetine in MSA patients [2]. - The three poster presentations will cover topics such as the impact of ampreloxetine on supine hypertension, retention strategies in rare disease clinical trials, and enrollment strategies in a Phase III trial for MSA-related nOH [2]. About Ampreloxetine - Ampreloxetine is an investigational, once-daily norepinephrine reuptake inhibitor aimed at treating symptomatic nOH in MSA patients [2][8]. - The treatment has shown an increase in norepinephrine levels and a favorable impact on blood pressure, with no worsening of supine hypertension reported [2]. - The company has received Orphan Drug Designation for ampreloxetine in the U.S. and plans to file a New Drug Application (NDA) if the ongoing Phase 3 CYPRESS study yields positive results [2]. Phase 3 Studies - The CYPRESS study is a registrational Phase 3 trial evaluating the efficacy and durability of ampreloxetine in MSA patients with symptomatic nOH after 20 weeks of treatment [3]. - The primary endpoint is the change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score [3]. - The REDWOOD study previously indicated that the benefits of ampreloxetine were particularly significant in MSA patients, with a 72% reduction in the odds of treatment failure compared to placebo [5]. Disease Context - Multiple system atrophy (MSA) is a progressive brain disorder affecting movement and balance, with approximately 50,000 patients in the U.S. [6]. - 70-90% of MSA patients experience symptomatic nOH, which is characterized by a significant drop in blood pressure upon standing [6][7]. - Neurogenic orthostatic hypotension (nOH) can lead to debilitating symptoms, including dizziness and fainting, severely impacting patients' quality of life [7].

Core Insights - Theravance Biopharma, Inc. will report its Q3 2025 financial results and provide a business update on November 10, 2025, after market close [1] - A conference call and webcast will be held on the same day at 5:00 pm EST [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, is being developed for neurogenic orthostatic hypotension in patients with Multiple System Atrophy, potentially becoming a first-in-class therapy [3]

Core Insights - Theravance Biopharma has launched a disease education campaign titled "Power in the Periphery" aimed at enhancing the understanding of neurogenic orthostatic hypotension (nOH) related to Multiple System Atrophy (MSA) [1][2] - The campaign was introduced at the International Congress of Parkinson's Disease and Movement Disorders, emphasizing the company's commitment to educating healthcare professionals about the complexities of nOH [2] Company Overview - Theravance Biopharma focuses on transforming the treatment landscape for specialty respiratory and neurologic diseases through innovative medicine development [6] Disease Context - Multiple System Atrophy (MSA) is a progressive brain disorder affecting movement and balance, with approximately 50,000 patients in the US, where 70-90% experience nOH symptoms [4] - Neurogenic orthostatic hypotension (nOH) is characterized by a significant drop in blood pressure upon standing, leading to debilitating symptoms such as dizziness and fainting [5]

Core Insights - Theravance Biopharma will present new analyses on YUPELRI at the CHEST 2025 annual meeting, highlighting its effectiveness in reducing exacerbations in COPD patients [1][2] Company Overview - Theravance Biopharma focuses on delivering impactful medicines, with YUPELRI (revefenacin) approved for the maintenance treatment of COPD [3] - The company is also developing Ampreloxetine, a potential first-in-class therapy for neurogenic orthostatic hypotension in patients with Multiple System Atrophy [3] Research Findings - A retrospective analysis showed that patients adherent to YUPELRI had significantly fewer exacerbations and lower healthcare costs compared to non-adherent patients [2][6] - Post-hoc analyses from a Phase 3 safety study indicated that YUPELRI's exacerbation profile over one year is at least as effective as tiotropium [2][6] Presentation Details - The presentations at CHEST 2025 include: - "Exacerbation Rates in COPD Patients: A Retrospective Analysis of the Nebulized Once Daily Long-Acting Muscarinic Antagonist Revefenacin in a 52-Week Safety Study" by Edmund J Moran, Ph.D. on October 21, 2025 [2] - "Adherence to Revefenacin Associated with Reductions in Exacerbations and Healthcare Costs Following a COPD-Related Hospitalization" by Grace Leung, MPH on October 21, 2025 [2]

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]