Theravance Biopharma, Inc. Reports Record Fourth Quarter and Full Year 2024 Financial Results
Theravance Biopharma (TBPH) reported strong Q4 and FY 2024 results, with YUPELRI achieving record US net sales of $66.7M in Q4 (up 10% YoY) and $238.6M for FY2024 (up 8% YoY). TRELEGY global net sales reached $3.46B in FY2024, up 26% YoY, triggering a $50M milestone payment to TBPH.
Q4 financial highlights include revenue of $18.8M from Viatris collaboration, R&D expenses of $9.5M, and SG&A expenses of $18.5M. The company ended Q4 with $88.4M in cash, excluding the $50M TRELEGY milestone received in February 2025.
For 2025 guidance, TBPH expects R&D expenses of $32-38M and SG&A expenses of $50-60M (excluding share-based compensation). The CYPRESS study for ampreloxetine remains on track to enroll its final patient by mid-2025.
Theravance Biopharma (TBPH) ha riportato risultati solidi per il Q4 e l'anno fiscale 2024, con YUPELRI che ha raggiunto vendite nette record negli Stati Uniti di $66,7 milioni nel Q4 (in aumento del 10% rispetto all'anno precedente) e $238,6 milioni per l'anno fiscale 2024 (in aumento dell'8% rispetto all'anno precedente). Le vendite nette globali di TRELEGY hanno raggiunto $3,46 miliardi nell'anno fiscale 2024, con un aumento del 26% rispetto all'anno precedente, attivando un pagamento di milestone di $50 milioni a TBPH.
Tra i punti salienti finanziari del Q4 ci sono ricavi di $18,8 milioni dalla collaborazione con Viatris, spese per R&S di $9,5 milioni e spese SG&A di $18,5 milioni. L'azienda ha chiuso il Q4 con $88,4 milioni in contante, escludendo i $50 milioni del pagamento di milestone di TRELEGY ricevuti a febbraio 2025.
Per le previsioni del 2025, TBPH prevede spese per R&S di $32-38 milioni e spese SG&A di $50-60 milioni (escludendo la compensazione basata sulle azioni). Lo studio CYPRESS per ampreloxetina è in programma di arruolare il suo paziente finale entro metà 2025.
Theravance Biopharma (TBPH) informó resultados sólidos para el cuarto trimestre y el año fiscal 2024, con YUPELRI alcanzando ventas netas récord en EE. UU. de $66.7 millones en el cuarto trimestre (un aumento del 10% interanual) y $238.6 millones para el año fiscal 2024 (un aumento del 8% interanual). Las ventas netas globales de TRELEGY alcanzaron $3.46 mil millones en el año fiscal 2024, un aumento del 26% interanual, lo que desencadenó un pago por hitos de $50 millones a TBPH.
Los aspectos destacados financieros del cuarto trimestre incluyen ingresos de $18.8 millones de la colaboración con Viatris, gastos de I+D de $9.5 millones y gastos SG&A de $18.5 millones. La compañía terminó el cuarto trimestre con $88.4 millones en efectivo, excluyendo los $50 millones del hito de TRELEGY recibidos en febrero de 2025.
Para las proyecciones de 2025, TBPH espera gastos de I+D de $32-38 millones y gastos SG&A de $50-60 millones (excluyendo la compensación basada en acciones). El estudio CYPRESS para ampreloxetina sigue en camino de inscribir a su paciente final para mediados de 2025.
Theravance Biopharma (TBPH)는 2024년 4분기 및 전체 연도에 대한 강력한 실적을 보고했습니다. YUPELRI는 4분기에 미국에서 기록적인 순매출 6670만 달러를 달성했으며(전년 대비 10% 증가), 2024년 전체 연도 순매출은 2억3860만 달러로(전년 대비 8% 증가) 기록했습니다. TRELEGY의 전 세계 순매출은 2024년 전체 연도에 34억6000만 달러에 달했으며, 이는 전년 대비 26% 증가하여 TBPH에 5000만 달러의 마일스톤 지급이 trigger되었습니다.
4분기 재무 하이라이트에는 Viatris와의 협력으로 인한 1880만 달러의 수익, 950만 달러의 R&D 비용, 1850만 달러의 SG&A 비용이 포함됩니다. 회사는 2025년 2월에 수령한 TRELEGY의 5000만 달러 마일스톤을 제외하고 4분기를 8840만 달러의 현금으로 마감했습니다.
2025년 가이던스를 위해 TBPH는 R&D 비용을 3200만에서 3800만 달러, SG&A 비용을 5000만에서 6000만 달러로 예상하고 있습니다(주식 기반 보상 제외). ampreloxetine에 대한 CYPRESS 연구는 2025년 중반까지 최종 환자를 등록할 예정입니다.
Theravance Biopharma (TBPH) a annoncé de solides résultats pour le quatrième trimestre et l'exercice 2024, avec YUPELRI atteignant des ventes nettes record aux États-Unis de 66,7 millions de dollars au quatrième trimestre (en hausse de 10 % par rapport à l'année précédente) et 238,6 millions de dollars pour l'exercice 2024 (en hausse de 8 % par rapport à l'année précédente). Les ventes nettes mondiales de TRELEGY ont atteint 3,46 milliards de dollars pour l'exercice 2024, soit une augmentation de 26 % par rapport à l'année précédente, déclenchant un paiement de jalon de 50 millions de dollars à TBPH.
Les points forts financiers du quatrième trimestre comprennent des revenus de 18,8 millions de dollars provenant de la collaboration avec Viatris, des dépenses de R&D de 9,5 millions de dollars et des dépenses SG&A de 18,5 millions de dollars. L'entreprise a terminé le quatrième trimestre avec 88,4 millions de dollars en liquidités, excluant les 50 millions de dollars du paiement de jalon de TRELEGY reçu en février 2025.
Pour les prévisions de 2025, TBPH prévoit des dépenses de R&D de 32 à 38 millions de dollars et des dépenses SG&A de 50 à 60 millions de dollars (hors rémunération en actions). L'étude CYPRESS pour l'ampréloxétine reste sur la bonne voie pour recruter son dernier patient d'ici mi-2025.
Theravance Biopharma (TBPH) berichtete über starke Ergebnisse für das 4. Quartal und das Geschäftsjahr 2024, wobei YUPELRI im 4. Quartal Rekordumsätze in den USA von 66,7 Millionen USD (10 % im Jahresvergleich) und 238,6 Millionen USD für das Geschäftsjahr 2024 (8 % im Jahresvergleich) erzielte. Die globalen Nettoumsätze von TRELEGY erreichten im Geschäftsjahr 2024 3,46 Milliarden USD, was einem Anstieg von 26 % im Jahresvergleich entspricht und eine Meilensteinzahlung von 50 Millionen USD an TBPH auslöste.
Die finanziellen Höhepunkte des 4. Quartals umfassen Einnahmen von 18,8 Millionen USD aus der Zusammenarbeit mit Viatris, F&E-Ausgaben von 9,5 Millionen USD und SG&A-Ausgaben von 18,5 Millionen USD. Das Unternehmen beendete das 4. Quartal mit 88,4 Millionen USD in bar, ohne die im Februar 2025 erhaltene Meilensteinzahlung von 50 Millionen USD für TRELEGY.
Für die Prognose 2025 erwartet TBPH F&E-Ausgaben von 32-38 Millionen USD und SG&A-Ausgaben von 50-60 Millionen USD (ohne aktienbasierte Vergütung). Die CYPRESS-Studie für Ampreloxetin ist auf Kurs, um bis Mitte 2025 den letzten Patienten einzuschreiben.
- YUPELRI Q4 net sales hit record $66.7M (+10% YoY)
- TRELEGY FY2024 sales of $3.46B triggered $50M milestone payment
- Hospital channel YUPELRI doses grew 49% YoY in Q4
- Strong cash position of $88.4M plus $50M milestone payment
- Q4 net loss increased to $15.5M from $8.5M YoY
- Non-GAAP net loss of $2.5M vs income of $1.4M in Q4 2023
- Higher SG&A expenses: $18.5M vs $15.5M YoY
Insights
Theravance Biopharma's Q4 and FY 2024 results reveal a company with strengthening commercial momentum and multiple near-term catalysts. YUPELRI's record quarterly sales of $66.7M (up 10% YoY) and annual sales of $238.6M (up 8% YoY) demonstrate sustained growth in the COPD market. The 49% YoY growth in hospital channel doses is particularly significant as hospital adoption often leads to continued outpatient use, creating a sustainable prescription funnel.
The company stands at an inflection point with several value-driving milestones approaching:
- YUPELRI needs just 4% growth to reach $250M in annual sales, triggering a $25M milestone payment
- TRELEGY's strong performance ($3.46B in 2024 sales, up 26%) has already secured a $50M milestone received in February 2025
- With minimal growth, TRELEGY could trigger an additional $50M milestone in 2025 and $100M in 2026
- Royalties of up to 8.5% on TRELEGY sales return to Theravance beginning mid-2029, representing substantial long-term value
The $88.4M cash position (now bolstered by the additional $50M milestone) provides runway for the company's ampreloxetine program, which could address an underserved market in neurogenic orthostatic hypotension. With final patient enrollment expected by mid-2025 and data six months later, this asset represents a potential growth driver beyond the respiratory portfolio.
The Board's strategic review signals a focus on unlocking shareholder value, which could result in various outcomes including partnerships, asset sales, or corporate transactions. With multiple revenue streams, approaching milestones, and management's projection of minimal cash burn in 2025, Theravance appears positioned to deliver increasing value while maintaining financial discipline.
Theravance Biopharma's Q4 results demonstrate strong commercial execution in respiratory care while advancing a promising neurology pipeline. YUPELRI's commercial trajectory shows accelerating momentum, with the 49% year-over-year growth in hospital channel doses particularly noteworthy. This hospital penetration is strategically valuable as it establishes YUPELRI in treatment protocols and creates prescribing patterns that extend into outpatient settings.
YUPELRI maintains a unique competitive advantage as the only once-daily nebulized LAMA for COPD, addressing a specific patient segment that prefers or requires nebulization over handheld inhalers. With $238.6M in 2024 sales, the product needs just 4% growth to trigger a $25M milestone - a threshold that appears achievable given current growth rates and expanding hospital adoption.
The TRELEGY franchise continues its impressive performance with 26% year-over-year growth to $3.46B. Beyond the immediate $50M milestone received in February, the product is positioned to generate substantial future value through additional milestones in 2025-2026 and the return of royalties to Theravance in 2029.
Ampreloxetine represents a potential breakthrough for MSA patients suffering from neurogenic orthostatic hypotension. Current treatments (midodrine, droxidopa) offer durability and efficacy, with many patients experiencing inadequate symptom control. The upcoming American Academy of Neurology presentations will provide critical data on ampreloxetine's impact on supine hypertension - a significant safety concern with existing therapies that often limits their utility.
The FDA's agreement on the content for a complete application and potential priority review could accelerate ampreloxetine's path to market. With final patient enrollment expected by mid-2025 and data six months later, this asset could begin generating revenue in 2026-2027, diversifying Theravance's portfolio beyond respiratory medicine.
The Board's strategic review suggests management recognizes potential disconnects between current valuation and the company's asset portfolio, creating possibilities for value-unlocking transactions in the near term.
- YUPELRI® (revefenacin) US net sales, recognized by Viatris, reached an all-time high of
$66.7 million $238.6 million 10% and8% , respectively, compared with 20231 - FY 2024 TRELEGY Net Sales, as reported by GSK, of
$3.46 billion 26% compared with 2023 and triggering a$50 million - CYPRESS study on track to enroll final patient in the open label portion by mid-2025
- Ended Q4 2024 with
$88 million $50 million
"Theravance Biopharma ended 2024 on a high note, having collaborated closely with Viatris to deliver record fourth quarter YUPELRI net sales and profitability, while achieving
Portfolio Highlights
YUPELRI® (revefenacin) inhalation solution, the first and only once-daily, nebulized LAMA (long- acting muscarinic agent) bronchodilator approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD):
- Achieved total US net sales of
$66.7 million 10% year-over-year (Q4 2024 vs Q4 2023), driven by increased customer demand.1,4 - Achieved 2024 total US net sales of
$238.6 million 8% year-over-year; Theravance Biopharma stands to receive a one-time$25 million $250 million 4% growth from 2024 levels. - Reached launch-to-date highs in brand profitability during the fourth quarter and full year 2024.
- Grew customer demand
9% for the quarter (Q4 2024 vs Q3 2024) and11% for the year.4 - Grew Q4 2024 doses sold into the hospital channel by
49% year-over-year (Q4 2024 vs Q4 2023), capping off a record year for hospital performance.5
TRELEGY
GSK posted Q4 2024 and FY 2024 global TRELEGY net sales of
- FY 2024 global net sales of
$3.46 billion $50M - FY 2024 global net sales of
$3.46 billion $50 million $3.41 billion 2% growth required to achieve$100 million $3.51 billion - Royalties of up to
8.5% on TRELEGY net sales return to Theravance Biopharma in eligible territories beginning mid-2029, a significant driver of long-term value.
Ampreloxetine, an investigational, once-daily norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA):
- On track to enroll the final patient in the open label portion of the CYPRESS in mid-2025, with top-line data anticipated to be available approximately six months later.
- Continue to prepare for an expedited NDA filing post CYPRESS readout and plan to request a priority review.
- Recent successful interaction with FDA confirming agreement on the content of a complete application, solidifying our path to an NDA.
- Two abstracts accepted for oral presentation at the American Academy of Neurology 2025 Annual Meeting taking place April 5–9, 2025, in
San Diego :- "The Impact of Ampreloxetine on Supine Hypertension: An Ambulatory Blood Pressure Monitoring Study"
- "NET-Inhibition with Ampreloxetine, Blood Pressure, and Catecholamines in Patients with Neurogenic Orthostatic Hypotension"
- Continued launch readiness activities, including primary provider-focused research. Initial findings confirm strong need for more effective therapies with greater durability in nOH in MSA, as well as existence of many MSA patients with persistent symptoms despite available therapies.
Fourth Quarter Financial Results
- Revenue: Total revenue for the fourth quarter of 2024 was
$18.8 million $1.4 million 8% , in the fourth quarter compared to the same period in 2023 due primarily to higher net sales. 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 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 fourth quarter of 2024 was$23.3 million 10% increase compared to the same period in 2023. - Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2024 were
$9.5 million $8.3 million $1.4 million $32.5 million $30 million $36 million - Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the fourth quarter of 2024 were
$18.5 million $15.5 million $4.4 million $52.9 million $45 million $55 million - Share-Based Compensation: Share-based compensation expenses for the fourth quarter of 2024 were
$5.8 million $5.8 million $1.4 million $4.4 million $1.7 million $4.1 million $21.4 million $18 million $22 million - Net Loss and Non-GAAP Net Income (Loss) from Operations6: Net loss was
$15.5 million $8.5 million $2.5 million $1.4 million - Cash Position: Cash, cash equivalents and marketable securities totaled
$88.4 million
Strategic Review Committee
Theravance Biopharma announced on November 12th, 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 Committee is continuing to evaluate a range of alternatives with the objective of unlocking shareholder value. Until this review is complete, we are not in a position to provide additional details on the review process.
2025 Financial Guidance
- Operating Expenses (excluding share-based compensation): The Company expects full year 2025 R&D expense of
$32 million $38 million $50 million $60 million - Share-Based Compensation: The Company expects full year share-based compensation expense of
$18 million $20 million - Non-GAAP Loss from Operations and Cash Burn6: The Company expects minimal levels of Non-GAAP Losses from Operations and Cash Burn in 2025, similar to levels incurred in 2024.
Conference Call and Live Webcast Today at 5:00 pm ET
Theravance Biopharma will hold a conference call and live webcast accompanied by slides today at 5:00 pm ET / 2:00 pm PT / 10:00 pm GMT. To participate in the live call by telephone, please register here. Those interested in listening to the conference call live via the internet may do so by visiting Theravance Biopharma's website at www.theravance.com, under the Investors section, Presentations and Events.
A replay of the webcast will be available on Theravance Biopharma's website for 30 days through March 28, 2025.
About Ampreloxetine
Ampreloxetine, an investigational, once-daily 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 US, the Company has been granted an Orphan Drug Designation for ampreloxetine for the treatment of symptomatic nOH in patients with MSA and, if results from the ongoing Phase 3 CYPRESS study are supportive, plans to file an NDA for full approval in this indication.
About CYPRESS (Study 0197), a Phase 3 Study
Study 0197 (NCT05696717) is currently enrolling. 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).7 There are approximately 50,000 MSA patients in the US8 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 Mylan Specialty L.P., a Viatris company. Trademarks, trade names or service marks of other companies appearing in this press release are the property of their respective owners.
Forward-Looking Statements
This press release and the conference call 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 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, potential, and objectives, future growth of YUPELRI sales, future milestone and royalty payments, the ability to provide value to shareholders, the Company's regulatory strategies and timing of clinical studies, potential or possible safety, efficacy or differentiation 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; contingent payments due to the Company from the sale of the Company's TRELEGY ELLIPTA royalty interests to Royalty Pharma, 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 Theravance Biopharma are in the Company's Form 10-Q filed with the SEC on November 14, 2024, 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 loss from continuing operations, 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
1 In the US, Viatris is leading the commercialization of YUPELRI, and Theravance Biopharma co-promotes the product under a profit and loss sharing arrangement ( |
2 GSK-reported Net Sales in USD. |
3 A first payment of |
4 Source: Viatris Customer Demand (Q4'24). |
5 Source: IQVIA DDD, HDS, VA and Non-Reporting Hospital through Dec '24. |
6 Non-GAAP profit (loss) consists of GAAP net loss before taxes less share-based compensation expense, non-cash interest expense, and non-cash impairment expense. See the section titled "Non-GAAP Financial Measures" for more information. |
7 https://medlineplus.gov/genetics/condition/multiple-system-atrophy/ |
8 UCSD Neurological Institute (25K-75K, with ~10K new cases per year); NIH National Institute of Neurological Disorders and Stroke (15K-50K). |
9 Delveinsight MSA Market Forecast (2023); Symptoms associated with orthostatic hypotension in pure autonomic failure and multiple systems atrophy, CJ Mathias (1999). |
THERAVANCE BIOPHARMA, INC. | |||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||
(In thousands) | |||||
December 31, | December 31, | ||||
2024 | 2023 | ||||
Assets | (Unaudited) | (1) | |||
Current assets: | |||||
Cash and cash equivalents and short-term marketable securities | $ | 88,350 | $ | 102,426 | |
Receivables from collaborative arrangements | 18,440 | 17,474 | |||
Receivables from milestone and royalty assets | 50,000 | - | |||
Prepaid clinical and development services | 73 | 2,038 | |||
Other prepaid and current assets | 4,204 | 11,603 | |||
Total current assets | 161,067 | 133,541 | |||
Property and equipment, net | 7,418 | 9,068 | |||
Operating lease assets | 28,354 | 36,287 | |||
Future contingent milestone and royalty assets | 144,200 | 194,200 | |||
Restricted cash | 836 | 836 | |||
Other assets | 12,286 | 8,067 | |||
Total assets | $ | 354,161 | $ | 381,999 | |
Liabilities and Shareholders' Equity | |||||
Current liabilities | $ | 32,085 | $ | 24,767 | |
Long-term operating lease liabilities | 39,108 | 45,236 | |||
Future royalty payment contingency | 30,334 | 27,788 | |||
Unrecognized tax benefits | 75,199 | 65,294 | |||
Other long-term liabilities | 1,890 | 5,919 | |||
Shareholders' equity | 175,545 | 212,995 | |||
Total liabilities and shareholders' equity | $ | 354,161 | $ | 381,999 | |
________________________________ | |||||
(1) The condensed consolidated balance sheet as of December 31, 2023 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, 2023. | |||||
THERAVANCE BIOPHARMA, INC. | ||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||
(In thousands, except per share data) | ||||||||||||
Three Months Ended December 31, | Year Ended December 31, | |||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||
(Unaudited) | (Unaudited) | |||||||||||
Revenue: | ||||||||||||
Viatris collaboration agreement (1) | $ | 18,754 | $ | 17,360 | $ | 64,381 | $ | 57,201 | ||||
Viatris royalties (Non-US) | - | 7 | - | 7 | ||||||||
Collaboration revenue | - | 198 | - | 216 | ||||||||
Total revenue | 18,754 | 17,565 | 64,381 | 57,424 | ||||||||
Costs and expenses: | ||||||||||||
Research and development (2) | 9,452 | 8,314 | 37,643 | 40,621 | ||||||||
Selling, general and administrative (2) | 18,502 | 15,492 | 69,174 | 70,095 | ||||||||
Impairment of long-lived assets (non-cash) | - | - | 4,513 | - | ||||||||
Restructuring and related expenses (2) | - | - | - | 2,743 | ||||||||
Total costs and expenses | 27,954 | 23,806 | 111,330 | 113,459 | ||||||||
Loss from operations | (9,200) | (6,241) | (46,949) | (56,035) | ||||||||
Interest expense (non-cash) | (643) | (623) | (2,546) | (2,350) | ||||||||
Interest income and other income, net | 902 | 1,847 | 4,881 | 9,116 | ||||||||
Loss before income taxes | (8,941) | (5,017) | (44,614) | (49,269) | ||||||||
Provision for income tax expense | (6,587) | (3,494) | (11,804) | (5,924) | ||||||||
Net loss | $ | (15,528) | $ | (8,511) | $ | (56,418) | $ | (55,193) | ||||
Net loss per share: | ||||||||||||
Basic and diluted net loss per share | $ | (0.31) | $ | (0.17) | $ | (1.15) | $ | (1.00) | ||||
Shares used to compute basic and diluted net loss per share | 49,306 | 49,415 | 48,847 | 55,303 | ||||||||
Non-GAAP net income (loss) | $ | (2,472) | $ | 1,431 | $ | (16,162) | $ | (21,548) | ||||
________________________________ | ||||||||||||
(1) While Viatris, Inc. records the total YUPELRI net sales, the Company is entitled to a | ||||||||||||
Three Months Ended December 31, | Year Ended December 31, | |||||||||||
(In thousands) | 2024 | 2023 | 2024 | 2023 | ||||||||
YUPELRI net sales ( | $ | 66,680 | $ | 60,644 | $ | 238,626 | $ | 220,962 | ||||
YUPELRI net sales (Theravance Biopharma implied | 23,338 | 21,225 | 83,519 | 77,337 | ||||||||
(2) Amounts include share-based compensation expense as follows: | ||||||||||||
Three Months Ended December 31, | Year Ended December 31, | |||||||||||
(In thousands) | 2024 | 2023 | 2024 | 2023 | ||||||||
Research and development | $ | 1,377 | $ | 1,747 | $ | 5,104 | $ | 8,048 | ||||
Selling, general and administrative | 4,449 | 4,078 | 16,289 | 16,966 | ||||||||
Restructuring and related expenses | - | - | - | 357 | ||||||||
Total share-based compensation expense | $ | 5,826 | $ | 5,825 | $ | 21,393 | $ | 25,371 | ||||
THERAVANCE BIOPHARMA, INC. | ||||||||||||
Reconciliation of GAAP to Non-GAAP Net Income (Loss) | ||||||||||||
(In thousands) | ||||||||||||
Three Months Ended December 31, | Year Ended December 31, | |||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||
(Unaudited) | (Unaudited) | |||||||||||
GAAP net loss | $ | (15,528) | $ | (8,511) | $ | (56,418) | $ | (55,193) | ||||
Adjustments: | ||||||||||||
Share-based compensation expense | 5,826 | 5,825 | 21,393 | 25,371 | ||||||||
Non-cash impairment of long-lived assets | - | - | 4,513 | - | ||||||||
Non-cash interest expense | 643 | 623 | 2,546 | 2,350 | ||||||||
Income tax expense | 6,587 | 3,494 | 11,804 | 5,924 | ||||||||
Non-GAAP net income (loss) | $ | (2,472) | $ | 1,431 | $ | (16,162) | $ | (21,548) | ||||
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SOURCE Theravance Biopharma, Inc.
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