Theravance Biopharma Third Quarter 2025 Financial Results and Business Update November 10, 2025 THERAVANCE BIOPHARMA®, THERAVANCE®, the Cross/Star logo and MEDICINES THAT MAKE A DIFFERENCE® are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries). All third-party trademarks used herein are the property of their respective owners. © 2025 Theravance Biopharma. All rights reserved. Forward Looking Statements Examples of such statements include statement ...

Financial Performance - YUPELRI achieved all-time high U.S. net sales of $71.4 million in Q3 2025, a 15% increase year-over-year driven by 6% customer demand growth [4]. - Total revenue for Q3 2025 was $20.0 million, with Viatris collaboration revenue increasing by 19% compared to Q3 2024 [13]. - Net income for Q3 2025 was $3.6 million, compared to a net loss of $12.7 million in Q3 2024, benefiting from a $6.5 million income tax benefit [17]. - Non-GAAP net income from operations was $2.3 million in Q3 2025, compared to a non-GAAP net loss of $2.9 million in Q3 2024 [17]. - Total revenue for Q3 2025 was $19,990,000, an increase of 18.5% compared to $16,868,000 in Q3 2024 [36]. - YUPELRI net sales recorded by Viatris for Q3 2025 were $71,363,000, up from $62,189,000 in Q3 2024, reflecting a growth of 17.5% [36]. - The company reported a net income of $3,615,000 for Q3 2025, compared to a net loss of $12,698,000 in Q3 2024, marking a significant turnaround [36]. - Non-GAAP net income for Q3 2025 was $2,260,000, compared to a loss of $2,897,000 in Q3 2024 [38]. Cash and Assets - Cash, cash equivalents, and marketable securities totaled $332.7 million as of September 30, 2025, with no debt [17]. - Cash and cash equivalents increased to $329,680,000 as of September 30, 2025, up from $88,350,000 at the end of 2024 [33]. - Total current assets rose to $354,697,000 as of September 30, 2025, compared to $161,067,000 at the end of 2024 [33]. - Shareholders' equity increased to $232,681,000 as of September 30, 2025, compared to $175,545,000 at the end of 2024 [33]. - The company has a future contingent milestone and royalty asset valued at $144,200,000 as of December 31, 2024 [33]. Research and Development - Research and Development expenses for Q3 2025 were $8.1 million, down from $9.3 million in Q3 2024 [13]. - Research and development expenses for Q3 2025 were $8,112,000, a decrease from $9,268,000 in Q3 2024 [36]. - The open-label portion of the pivotal Phase 3 CYPRESS study of ampreloxetine is complete, with topline results expected in Q1 2026 [6]. - 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 [9]. Future Projections - The company is on track to exceed full year 2025 global net sales of approximately $3.4 billion, requiring $471 million in Q4 2025 to trigger a $50 million milestone from Royalty Pharma [12]. - Year-to-date sales of TRELEGY are on track to achieve a $50 million milestone in 2025, with global net sales of approximately $2.9 billion, up 13% year-over-year [7]. Expenses - Selling, general and administrative expenses increased to $18,333,000 in Q3 2025 from $16,875,000 in Q3 2024 [36].

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]

Core Insights - Theravance Biopharma Inc. has received an upgrade in its MSCI ESG rating from BBB to A as of October 30, 2025 [1] Company Summary - The upgrade reflects an improvement in Theravance Biopharma's environmental, social, and governance practices [1]

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]