Theravance Biopharma, Inc. Reports Third Quarter 2025 Financial Results and Provides Corporate Update
Theravance Biopharma (NASDAQ: TBPH) reported Q3 2025 results on Nov 10, 2025: YUPELRI U.S. net sales hit a record $71.4M (+15% YoY) and brand profitability improved. The company achieved non-GAAP breakeven in Q3 and ended September 30 with $332.7M cash and no debt. Enrollment in the pivotal Phase 3 CYPRESS trial of ampreloxetine is complete; the open-label portion finished and topline readout is expected in Q1 2026, with plans to prepare an expedited NDA and request priority review if supportive. TRELEGY global sales trends are on track to trigger milestone payments from Royalty Pharma if required sales levels are met in Q4 2025. A virtual KOL investor event on ampreloxetine is scheduled for Dec 8, 2025.
Theravance Biopharma (NASDAQ: TBPH) ha riportato i risultati del Q3 2025 il 10 novembre 2025: le vendite nette USA di YUPELRI hanno raggiunto un record 71,4 milioni di dollari (+15% YoY) e la redditività del marchio è migliorata. L’azienda ha raggiunto il break-even non GAAP nel Q3 e al 30 settembre disponeva di 332,7 milioni di dollari in cassa e nessun debito. L’arruolamento nello studio pivotale di fase 3 CYPRESS di ampreloxetine è completo; la parte in aperta etichetta è terminata e il readout principale è previsto nel Q1 2026, con piani per preparare una NDA accelerata e richiedere una revisione prioritaria se a supporto. Le tendenze delle vendite globali di TRELEGY sono sulla buona strada per attivare pagamenti di milestone da Royalty Pharma se i livelli di vendita richiesti saranno raggiunti nel Q4 2025. Un evento virtuale KOL per investitori su ampreloxetine è previsto per 8 dicembre 2025.
Theravance Biopharma (NASDAQ: TBPH) informó los resultados del tercer trimestre de 2025 el 10 de noviembre de 2025: las ventas netas en EE. UU. de YUPELRI alcanzaron un récord de 71,4 millones de dólares (+15% interanual) y la rentabilidad de la marca mejoró. La empresa alcanzó el punto de equilibrio no GAAP en el Q3 y terminó el 30 de septiembre con 332,7 millones de dólares en efectivo y sin deuda. El reclutamiento en el ensayo pivotal de fase 3 CYPRESS de ampreloxetine está completo; la porción en abierto terminó y se espera el readout principal en el Q1 2026, con planes de preparar una NDA acelerada y solicitar revisión prioritaria si es favorable. Las tendencias de ventas globales de TRELEGY están en camino de activar pagos por hitos de Royalty Pharma si se alcanzan los niveles de ventas requeridos en el Q4 2025. Un evento virtual para inversores KOL sobre ampreloxetine está programado para el 8 de diciembre de 2025.
Theravance Biopharma (NASDAQ: TBPH) 은 2025년 11월 10일 2025년 3분기 실적을 발표했습니다: 미국 내 YUPELRI의 순매출이 사상 최대치를 기록하여 7,140만 달러를 기록했고(+전년 동기 대비 15%), 브랜드의 수익성도 개선되었습니다. 회사는 3분기에 비 GAAP 손익분기점을 달성했고 9월 30일 기준 현금 3억 3,270만 달러를 보유하고 부채는 없었습니다. ampreloxetine의 핵심 3상 CYPRESS 시험에 대한 등록은 완료되었고, 오픈-라벨(Open-label) 부분이 종료되었으며 주요 결과는 2026년 1분기에 예상되며, 지지 시 신속 NDA를 준비하고 우선 심사를 요청할 계획이 있습니다. TRELEGY의 글로벌 매출 추세는 2025년 4분기에 필요한 매출 수준이 달성되면 Royalty Pharma의 이정표 지급을 촉발할 가능성이 있습니다. 12월 8일 2025년에 ampreloxetine 관련 가상 KOL 투자자 이벤트가 예정되어 있습니다.
Theravance Biopharma (NASDAQ: TBPH) a publié les résultats du T3 2025 le 10 novembre 2025 : les ventes nettes US de YUPELRI ont atteint un record de 71,4 millions de dollars (+15 % YoY) et la rentabilité de la marque s’est améliorée. L’entreprise a atteint l’équilibre non GAAP au T3 et, au 30 septembre, disposait de 332,7 millions de dollars en liquidités et aucune dette. L’inscription dans l’étude pivot de phase 3 CYPRESS d’ampreloxetine est complète ; la partie en open-label est terminée et le readout principal est attendu au Q1 2026, avec des plans pour préparer une NDA accélérée et demander une révision prioritaire si favorable. Les tendances de ventes mondiales de TRELEGY sont en bonne voie pour déclencher des paiements de jalons de Royalty Pharma si les niveaux de ventes requis sont atteints au Q4 2025. Un événement virtuel KOL investisseurs sur ampreloxetine est prévu pour le 8 décembre 2025.
Theravance Biopharma (NASDAQ: TBPH) berichtete am 10. November 2025 über die Ergebnisse von Q3 2025: Die US-Verkäufe von YUPELRI erreichten einen Rekord von 71,4 Mio. USD (+15 % YoY) und die Markenprofitabilität verbesserte sich. Das Unternehmen erreichte im Q3 Non-GAAP-Breakeven und beendete den Monat September mit 332,7 Mio. USD Bargeld und ohne Schulden. Die Einschreibung in die zentrale Phase-3-Studie CYPRESS von ampreloxetine ist abgeschlossen; der Open-Label-Teil ist beendet und der topline-Readout wird im Q1 2026 erwartet, mit Plänen, eine beschleunigte NDA vorzubereiten und eine priorisierte Prüfung zu beantragen, falls unterstützend. Die globalen TRELEGY-Umsatztrends befinden sich auf dem Weg, Meilensteinzahlungen von Royalty Pharma auszulösen, wenn die erforderlichen Verkaufsniveaus im Q4 2025 erreicht werden. Eine virtuelle KOL-Investor-Veranstaltung zu ampreloxetine ist für den 8. Dezember 2025 geplant.
Theravance Biopharma (NASDAQ: TBPH) أبلغت عن نتائج الربع الثالث 2025 في 10 نوفمبر 2025: مبيعات YUPELRI في الولايات المتحدة الصافية وصلت إلى رقم قياسي قدره 71.4 مليون دولار (+5% مقارنة بالعام السابق) وتحسن ربحية العلامة التجارية. حققت الشركة التعادل غير GAAP في الربع الثالث وأنهت سبتمبر 30 وبإجمالي نقدي قدره 332.7 مليون دولار وبدون ديون. تم إتمام التسجيل في تجربة المرحلة 3 CYPRESS المحورية لـ ampreloxetine؛ انتهى الجزء ذو الملصق المفتوح والمتوقع قراءة النتائج الرئيسية في الربع الأول 2026، مع خطط لإعداد NDA مُسرَّعة وطلب مراجعة أولوية إذا كان ذلك داعماً. الاتجاهات العالمية لمبيعات TRELEGY في المسار الصحيح لتحفيز مدفوعات معلم من Royalty Pharma إذا تم تحقيق مستويات المبيعات المطلوبة في الربع الرابع 2025. من المقرر عقد حدث افتراضي لجهات KOL المستثمرين حول ampreloxetine في 8 ديسمبر 2025.
- YUPELRI net sales reached $71.4M in Q3 2025 (+15% YoY)
- Achieved non-GAAP breakeven in Q3 2025
- Cash, cash equivalents and marketable securities of $332.7M as of Sept 30, 2025
- Completed enrollment and open-label portion of Phase 3 CYPRESS for ampreloxetine; topline due Q1 2026
- TRELEGY sales trajectory on track to trigger a $50M milestone from Royalty Pharma
- Q3 net income of $3.6M relied on a $6.5M income tax benefit; excluding it would be a $2.9M net loss
- Requires approximately $54M of YUPELRI net sales in Q4 2025 to trigger a $25M milestone from Viatris
- Needs roughly $471M of TRELEGY global net sales in Q4 2025 to secure the $50M Royalty Pharma milestone
Insights
Strong commercial traction for YUPELRI and improved P&L, supported by a healthy cash balance and milestone pathways.
YUPELRI reached an all-time quarterly net sales high of
Dependencies include recognition timing from Viatris and achieving the listed sales milestones: roughly
Ampreloxetine Phase 3 topline readout is a clear near‑term clinical catalyst with potential regulatory action if supportive.
Enrollment in the pivotal CYPRESS trial completed in August 2025 and the open‑label portion is now complete; topline results are expected in
Primary dependencies are the undisclosed topline outcomes and regulatory assessment; the near-term items to monitor are the actual CYPRESS topline results in
-
YUPELRI® net sales reached an all-time high of
, recognized by Viatris, up$71.4 million 15% year-over-year 1 , and achieved record brand profitability - Open-label portion of the pivotal Phase 3 CYPRESS study of ampreloxetine now complete; topline readout on track for Q1 2026
- Company to host an ampreloxetine focused virtual Key Opinion Leader (KOL) event for investors on December 8, 2025
-
TRELEGY year-to-date sales on track to achieve
milestone in 2025 2$50 million -
Strong balance sheet with
in cash and no debt$333 million
"Theravance delivered strong results in the third quarter, highlighted by record YUPELRI net sales and the achievement of non-GAAP breakeven, underscoring our commitment to financial and operational discipline," said Rick E Winningham, Chief Executive Officer of Theravance Biopharma. "In parallel, we continue to advance ampreloxetine toward topline results from the pivotal Phase 3 CYPRESS study in the first quarter of 2026. Backed by a strong balance sheet, durable YUPELRI cash flow, and multiple high-value milestones ahead, we approach this important catalyst from a position of strength—ready to deliver results that could transform the standard of care for multiple system atrophy patients and drive lasting value for patients and shareholders."
Operational Highlights:
YUPELRI ® (revefenacin) inhalation solution, the first and only once-daily, nebulized LAMA (long-acting muscarinic antagonist) bronchodilator approved in the U.S. for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD):
- Achieved all-time high
U.S. net sales of in Q3 2025, increasing$71.4 million 15% year-over-year (YoY) (Q3 2025 vs Q3 2024)1 driven by customer demand growth of6% YoY (Q3 2025 vs Q3 2024)3 and improved net pricing due to favorable channel mix. - Approximately
required in Q4 2025 to trigger$54 million milestone for the achievement of$25 million of net sales in 2025.4$250 million - Increased doses pulled through the hospital channel by
29% YoY (Q3 2025 vs Q3 2024), reflecting another quarter of strong momentum.5 - Presented two oral presentations at the 2025 CHEST Annual Meeting that further support YUPELRI as an effective maintenance treatment for patients with COPD.
Ampreloxetine, an investigational, once-daily, selective norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA):
- Completed enrollment in the pivotal Phase 3 CYPRESS trial in August 2025; the open-label portion of the study has now completed, with topline results expected in Q1 2026.
- The Company continues to prepare for an expedited NDA submission and, if data are supportive, is planning to request priority FDA review.
- Theravance to host a virtual KOL event for investors on December 8, 2025, at 10:30 AM ET, featuring Dr. Horacio Kaufmann, M.D.; F. B. Axelrod Professor of Neurology and Professor of Medicine at NYU Grossman School of Medicine. The event will discuss the significant unmet need in patients with nOH due to MSA, ampreloxetine's potential as a precision medicine approach in these patients, and if data are supportive, the significant commercial opportunity.
- A manuscript titled "Establishing Minimally Clinically Important Differences for the Orthostatic Hypotension Questionnaire (OHQ)" by Kaufmann H, et al. has been published in Clinical Autonomic Research.
- Presented one platform presentation and three poster presentations at the International Symposium on The Autonomic Nervous System. The presentations highlighted the results from the previous REDWOOD trial, where we observed a durable symptomatic nOH benefit with improvement in activities of daily living in the pre-specified subgroup analysis in patients with MSA treated with ampreloxetine.6 Additional data was presented on the rigorous methodologies we developed based on previous trials experience to support enrollment and patient retention in the ongoing Phase 3 CYPRESS study.
TRELEGY
GSK reported third quarter 2025 global net sales of approximately
- On track to exceed full year (FY) 2025 global net sales of
~ required to trigger$3.4 billion milestone from Royalty Pharma.$50 million - Approximately
of global net sales required in Q4 2025 to trigger the$471 million milestone.$50 million
- Approximately
- FY 2026 global net sales of
~ required to trigger an additional$3.5 billion milestone from Royalty Pharma.$100M
Disease State Awareness
- Launched a new disease education campaign (www.nOHuncovered.com) for healthcare professionals (HCPs) to raise awareness and deepen scientific understanding of the pathophysiology underlying neurogenic orthostatic hypotension (nOH) associated with Multiple System Atrophy (MSA) in October 2025.
Third Quarter Financial Results
-
Revenue: Total revenue for the third quarter of 2025 was
, consisting entirely of Viatris collaboration revenue. Viatris collaboration revenue increased by$20.0 million , or$3.1 million 19% , in the third quarter compared to the same period in 2024. The Viatris collaboration revenue represents amounts receivable from Viatris and comprises the Company's35% share of net sales of YUPELRI, as well as its proportionate amount of the total shared commercial costs incurred by the two companies. The non-shared YUPELRI costs incurred by Theravance Biopharma are recorded within operating expenses. While Viatris records the total net sales of YUPELRI within its financial statements, Theravance Biopharma's implied35% share of net sales of YUPELRI for the third quarter of 2025 was which represented a$25.0 million 15% increase compared to the same period in 2024. -
Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2025 were
, compared to$8.1 million in the same period in 2024. Third quarter R&D expenses included total non-cash share-based compensation of$9.3 million .$1.1 million -
Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the third quarter of 2025 were
, compared to$18.3 million in the same period in 2024. Third quarter SG&A expenses included total non-cash share-based compensation of$16.9 million .$3.5 million -
Share-Based Compensation: Share-based compensation expenses for the third quarter of 2025 were
, compared to$4.6 million in the same period in 2024. Share-based compensation expenses consisted of$5.0 million for R&D and$1.1 million for SG&A in the third quarter of 2025, compared to$3.5 million and$1.1 million , respectively, in the same period in 2024.$3.9 million -
Income Taxes: Income tax benefit for the third quarter of 2025 was
, compared to a$6.5 million income tax expense in the same period in 2024. The benefit reflects a favorable true-up related to taxes from the$2.6 million TRELEGY royalty sale in Q2 2025.$225.0 million -
Net Income: Net income was
in the third quarter of 2025 compared to a net loss of$3.6 million in the same period in 2024. The net income benefited from the income tax benefit as noted above. Excluding the$12.7 million income tax benefit, third quarter net loss would have been$6.5 million .$2.9 million -
Non-GAAP Net Income from Operations7: Non-GAAP net income from operations was
in the third quarter of 2025 compared to a non-GAAP net loss from operations of$2.3 million in the same period in 2024. See the section titled "Non-GAAP Financial Measures" for more information.$2.9 million -
Cash Position: Cash, cash equivalents and marketable securities totaled
as of September 30, 2025.$332.7 million
2025 Financial Guidance
-
Operating Expenses (
excluding share-based compensation)
: The Company continues to expect full year 2025 R&D expenses of
to$32 million and SG&A expenses of$38 million to$50 million , in each case excluding share-based compensation.$60 million -
Share-Based Compensation: The Company continues to expect full-year share-based compensation expenses of
to$18 million .$20 million - Non-GAAP Net Income from Operations7: Achieved breakeven non-GAAP net income in Q3 2025; non-GAAP margin expected to remain at similar breakeven levels in Q4 2025, excluding one-time items, reflecting sustained operating discipline.
Strategic Review Committee
- Theravance Biopharma announced on November 12, 2024, that the Board of Directors had formed a Strategic Review Committee (the "Committee"), composed entirely of independent directors to assess all strategic alternatives available to the Company.
- The Company remains focused on disciplined capital allocation and returning excess cash to shareholders. The Committee will continue to evaluate a range of alternatives to further enhance shareholder value, though there can be no assurance that additional transactions will occur.
Conference Call and Live Webcast Today at 5:00 pm EST
Theravance Biopharma will hold a conference call and live webcast accompanied by slides today at 5:00 pm EST / 2:00 pm PST / 10:00 pm GMT. To participate in the live call by telephone, please pre-register here. Those interested in the live audio webcast of the conference call may access it by clicking here or visiting the Events and Presentations page under the Investors Section on Theravance Biopharma's website.
A replay of the webcast will be available on Theravance Biopharma's website for 30 days through December 10, 2025.
About Ampreloxetine
Ampreloxetine, an investigational, once-daily, selective norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA). The unique benefits of ampreloxetine treatment reported in MSA patients from Study 0170 included an increase in norepinephrine levels, a favorable impact on blood pressure, clinically meaningful and durable symptom improvement, and no signal for worsening of supine hypertension. In the
About CYPRESS (Study 0197), a Phase 3 Study
Study 0197 (NCT05696717) has completed enrollment. This is a registrational Phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment; the primary endpoint of the study is change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score. The Study includes four periods: screening, open label (12-week period, participants will receive a single daily 10 mg dose of ampreloxetine), randomized withdrawal (eight-week period, double-blind, placebo-controlled, participants will receive a single daily 10 mg dose of placebo or ampreloxetine), and a long-term treatment extension. Secondary outcome measures include change from baseline in Orthostatic Hypotension Daily Activity Scale (OHDAS) item 1 (activities that require standing for a short time) and item 3 (activities that require walking for a short time).
About Multiple System Atrophy (MSA) and Symptomatic Neurogenic Orthostatic Hypotension (nOH)
MSA is a progressive brain disorder that affects movement and balance and disrupts the function of the autonomic nervous system. The autonomic nervous system controls body functions that are mostly involuntary. One of the most frequent autonomic symptoms associated with MSA is a sudden drop in blood pressure upon standing (nOH).8 There are approximately 50,000 MSA patients in the US9 and 70
Neurogenic orthostatic hypotension (nOH) is a rare disorder defined as a fall in systolic blood pressure of ⩾20 mm Hg or diastolic blood pressure of ⩾10 mm Hg, within 3 minutes of standing. Severely affected patients are unable to stand for more than a few seconds because of their decrease in blood pressure, leading to cerebral hypoperfusion and syncope. A debilitating condition, nOH results in a range of symptoms including dizziness, lightheadedness, fainting, fatigue, blurry vision, weakness, trouble concentrating, and head and neck pain.
About Theravance Biopharma
Theravance Biopharma, Inc.'s focus is to deliver Medicines that Make a Difference® in people's lives. In pursuit of its purpose, Theravance Biopharma leverages decades of expertise, which has led to the development of FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Ampreloxetine, its late-stage investigational once-daily norepinephrine reuptake inhibitor in development for symptomatic neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA), has the potential to be a first in class therapy effective in treating a constellation of cardinal symptoms in MSA patients. The Company is committed to creating/driving shareholder value.
For more information, please visit www.theravance.com.
THERAVANCE BIOPHARMA®, THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries).
YUPELRI® is a registered trademark of Viatris Specialty LLC. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.
Forward-Looking Statements
This press release will contain certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events. Theravance Biopharma, Inc. (the "Company") intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to: the Company's expectations regarding its future profitability, expenses and uses of cash, the Company's goals, designs, strategies, plans and objectives, future growth of YUPELRI sales, future milestone or royalty payments, the ability to provide value to shareholders, the Company's regulatory strategies and timing of clinical studies, the safety, efficacy or differentiation of our investigational therapy, commercial potential and market opportunity of our investigational therapy, the status of patent infringement litigation initiated by the Company and its partner against certain generic companies in federal district courts, and expectations around the use of OHSA scores as endpoints for clinical trials. These statements are based on the current estimates and assumptions of the management of Theravance Biopharma as of the date of this press release and the conference call and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance Biopharma to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: factors that could increase the Company's cash requirements or expenses beyond its expectations and any factors that could adversely affect its profitability, whether the milestone thresholds can be achieved, delays or difficulties in commencing, enrolling or completing clinical studies, the potential that results from clinical or non-clinical studies indicate the Company's product candidates or product are unsafe, ineffective or not differentiated, risks of decisions from regulatory authorities that are unfavorable to the Company, dependence on third parties to conduct clinical studies, delays or failure to achieve and maintain regulatory approvals for product candidates, risks of collaborating with or relying on third parties to discover, develop, manufacture and commercialize products, and risks associated with establishing and maintaining sales, marketing and distribution capabilities with appropriate technical expertise and supporting infrastructure, the ability of the Company to protect and to enforce its intellectual property rights, volatility and fluctuations in the trading price and volume of the Company's shares, and general economic and market conditions. Other risks affecting the Company are in the Company's Form 10-Q filed with the SEC on August 13, 2025, and other periodic reports filed with the SEC. In addition to the risks described above and in Theravance Biopharma's filings with the SEC, other unknown or unpredictable factors also could affect Theravance Biopharma's results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance Biopharma assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.
Non-GAAP Financial Measures
Theravance Biopharma provides a non-GAAP profitability target and a non-GAAP metric in this press release. Theravance Biopharma believes that the non-GAAP profitability target and non-GAAP net income (loss) provide meaningful information to assist investors in assessing prospects for future performance and actual performance as they provide better metrics for analyzing the performance of its business by excluding items that may not be indicative of core operating results and the Company's cash position. Because non-GAAP financial targets and metrics, such as non-GAAP profitability and non-GAAP net income (loss), are not standardized, it may not be possible to compare these measures with other companies' non-GAAP targets or measures having the same or a similar name. Thus, Theravance Biopharma's non-GAAP measures should be considered in addition to, not as a substitute for, or in isolation from, the Company's actual GAAP results and other targets.
Please see the appendix attached to this press release for a reconciliation of non-GAAP net income (loss) to its corresponding measure, net income (loss). A reconciliation of non-GAAP net income (loss) to its corresponding GAAP measure is not available on a forward-looking basis without unreasonable effort due to the uncertainty regarding, and the potential variability of, expenses and other factors in the future.
Contact:
investor.relations@theravance.com
650-808-4045
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1 |
In the |
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2 |
Payments from Royalty Pharma (RP) will be triggered if RP receives certain minimum royalty payments from GSK based on TRELEGY global net sales. |
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3 |
Source: Viatris Customer Demand (Q3'25). |
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4 |
As of 09/30/25, Theravance Biopharma is eligible to receive from Viatris potential global development, regulatory and sales milestone payments (excluding |
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5 |
Source: IQVIA DDD, HDS, VA and Non-Reporting Hospital through Sept '25. |
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6 |
Freeman R, et al. Precision therapy with ampreloxetine for neurogenic orthostatic hypotension in multiple system atrophy. MedRxiv. https://doi.org/10.1101/2025.08.12.25332833. |
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7 |
Non-GAAP profit (loss) consists of GAAP net income (loss) before taxes less (i) share-based compensation expense, (ii) non-cash interest expense, (iii) non-cash impairment charges, and (iv) non-recurring revenue and income items. See the section titled "Non-GAAP Financial Measures" for more information. |
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8 |
https://medlineplus.gov/genetics/condition/multiple-system-atrophy/ |
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9 |
UCSD Neurological Institute (25K-75K, with ~10K new cases per year); NIH National Institute of Neurological Disorders and Stroke (15K-50K). |
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10 |
Delveinsight MSA Market Forecast (2023); Symptoms associated with orthostatic hypotension in pure autonomic failure and multiple systems atrophy, CJ Mathias (1999). |
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11 |
Data on file. MSA Natural History Statistics, NYU September 2019. |
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THERAVANCE BIOPHARMA, INC. |
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CONDENSED CONSOLIDATED BALANCE SHEETS |
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(In thousands) |
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September 30, |
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December 31, |
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2025 |
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2024 |
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Assets |
(Unaudited) |
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(1) |
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Current assets: |
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Cash and cash equivalents and short-term marketable securities |
$ |
329,680 |
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$ |
88,350 |
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Receivables from collaborative arrangements |
|
18,267 |
|
|
18,440 |
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Receivables from milestone and royalty assets |
|
- |
|
|
50,000 |
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Other prepaid and current assets |
|
6,750 |
|
|
4,277 |
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Total current assets |
|
354,697 |
|
|
161,067 |
|
Long-term marketable securities |
|
3,029 |
|
|
- |
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Property and equipment, net |
|
6,257 |
|
|
7,418 |
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Operating lease assets |
|
25,450 |
|
|
28,354 |
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Future contingent milestone and royalty assets |
|
- |
|
|
144,200 |
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Restricted cash |
|
836 |
|
|
836 |
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Other assets |
|
25,191 |
|
|
12,286 |
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Total assets |
$ |
415,460 |
|
$ |
354,161 |
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|
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|
|
|
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Liabilities and Shareholders' Equity |
|
|
|
|
|
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Income tax payable |
$ |
4,074 |
|
$ |
5,853 |
|
Other current liabilities |
|
33,333 |
|
|
26,232 |
|
Total current liabilities |
|
37,407 |
|
|
32,085 |
|
Long-term operating lease liabilities |
|
33,681 |
|
|
39,108 |
|
Future royalty payment contingency |
|
32,213 |
|
|
30,334 |
|
Unrecognized tax benefits |
|
79,165 |
|
|
75,199 |
|
Other long-term liabilities |
|
313 |
|
|
1,890 |
|
Shareholders' equity |
|
232,681 |
|
|
175,545 |
|
Total liabilities and shareholders' equity |
$ |
415,460 |
|
$ |
354,161 |
|
|
|
|
|
|
|
|
________________________________ |
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) The condensed consolidated balance sheet as of December 31, 2024 has been derived from the audited consolidated financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2024. |
|||||
|
THERAVANCE BIOPHARMA, INC. |
||||||||||||
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||||||
|
(In thousands, except per share data) |
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
||||||||
|
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
||||
|
|
|
(Unaudited) |
|
(Unaudited) |
||||||||
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Viatris collaboration agreement (1) |
|
$ |
19,990 |
|
$ |
16,868 |
|
$ |
54,073 |
|
$ |
45,627 |
|
Licensing revenue |
|
|
- |
|
|
- |
|
|
7,500 |
|
|
- |
|
Total revenue |
|
|
19,990 |
|
|
16,868 |
|
|
61,573 |
|
|
45,627 |
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development (2) |
|
|
8,112 |
|
|
9,268 |
|
|
30,054 |
|
|
28,190 |
|
Selling, general and administrative (2) |
|
|
18,333 |
|
|
16,875 |
|
|
55,132 |
|
|
50,673 |
|
Impairment of long-lived assets (non-cash) |
|
|
- |
|
|
1,562 |
|
|
- |
|
|
4,513 |
|
Total costs and expenses |
|
|
26,445 |
|
|
27,705 |
|
|
85,186 |
|
|
83,376 |
|
Loss from operations |
|
|
(6,455) |
|
|
(10,837) |
|
|
(23,613) |
|
|
(37,749) |
|
Net gain on realized contingent milestone and royalty assets |
|
|
- |
|
|
- |
|
|
75,137 |
|
|
- |
|
Interest expense (non-cash) |
|
|
(573) |
|
|
(630) |
|
|
(1,879) |
|
|
(1,903) |
|
Interest income and other income, net |
|
|
4,139 |
|
|
1,415 |
|
|
6,534 |
|
|
3,977 |
|
Loss before income taxes |
|
|
(2,889) |
|
|
(10,052) |
|
|
56,179 |
|
|
(35,675) |
|
Provision for income tax benefit (expense) |
|
|
6,504 |
|
|
(2,646) |
|
|
(11,308) |
|
|
(5,216) |
|
Net income (loss) |
|
$ |
3,615 |
|
$ |
(12,698) |
|
$ |
44,871 |
|
$ |
(40,891) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share - basic |
|
$ |
0.07 |
|
$ |
(0.26) |
|
$ |
0.89 |
|
$ |
(0.84) |
|
Net income (loss) per share - diluted |
|
$ |
0.07 |
|
$ |
(0.26) |
|
$ |
0.88 |
|
$ |
(0.84) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used to compute net income (loss) per share - basis |
|
|
50,520 |
|
|
49,038 |
|
|
50,137 |
|
|
48,690 |
|
Shares used to compute net income (loss) per share - diluted |
|
|
51,908 |
|
|
49,038 |
|
|
50,976 |
|
|
48,690 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income (loss) |
|
$ |
2,260 |
|
$ |
(2,897) |
|
$ |
(10,583) |
|
$ |
(13,692) |
|
________________________________ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) While Viatris, Inc. records the total YUPELRI net sales, the Company is entitled to a |
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
||||||||
|
(In thousands) |
|
2025 |
|
2024 |
|
2025 |
|
2024 |
||||
|
YUPELRI net sales ( |
|
$ |
71,363 |
|
$ |
62,189 |
|
$ |
196,037 |
|
$ |
171,945 |
|
YUPELRI net sales (Theravance Biopharma implied |
|
|
24,977 |
|
|
21,766 |
|
|
68,613 |
|
|
60,181 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2) Amounts include share-based compensation expense as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
||||||||
|
(In thousands) |
|
2025 |
|
2024 |
|
2025 |
|
2024 |
||||
|
Research and development |
|
$ |
1,080 |
|
$ |
1,111 |
|
$ |
3,137 |
|
$ |
3,727 |
|
Selling, general and administrative |
|
|
3,496 |
|
|
3,852 |
|
|
10,859 |
|
|
11,840 |
|
Total share-based compensation expense |
|
$ |
4,576 |
|
$ |
4,963 |
|
$ |
13,996 |
|
$ |
15,567 |
|
THERAVANCE BIOPHARMA, INC. |
||||||||||||
|
Reconciliation of GAAP Net Income (Loss) to Non-GAAP Net Income (Loss) |
||||||||||||
|
(In thousands) |
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
||||||||
|
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
||||
|
|
|
(Unaudited) |
|
(Unaudited) |
||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net income (loss) |
|
$ |
3,615 |
|
$ |
(12,698) |
|
$ |
44,871 |
|
$ |
(40,891) |
|
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing revenue (1) |
|
|
- |
|
|
- |
|
|
(7,500) |
|
|
- |
|
Net gain on realized contingent milestone and royalty assets (1) |
|
|
- |
|
|
- |
|
|
(75,137) |
|
|
- |
|
Non-cash impairment expense of long-lived assets (1) |
|
|
- |
|
|
1,562 |
|
|
- |
|
|
4,513 |
|
Share-based compensation expense |
|
|
4,576 |
|
|
4,963 |
|
|
13,996 |
|
|
15,567 |
|
Non-cash interest expense |
|
|
573 |
|
|
630 |
|
|
1,879 |
|
|
1,903 |
|
Income tax benefit (expense) |
|
|
(6,504) |
|
|
2,646 |
|
|
11,308 |
|
|
5,216 |
|
Non-GAAP net income (loss) |
|
$ |
2,260 |
|
$ |
(2,897) |
|
$ |
(10,583) |
|
$ |
(13,692) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Non-recurring item |
|
|
|
|
|
|
|
|
|
|
|
|
View original content to download multimedia:https://www.prnewswire.com/news-releases/theravance-biopharma-inc-reports-third-quarter-2025-financial-results-and-provides-corporate-update-302610645.html
SOURCE Theravance Biopharma, Inc.