Theravance Biopharma Announces Approval of YUPELRI® (revefenacin) by China's NMPA
Theravance Biopharma (NASDAQ:TBPH) announced that its partner Viatris has received approval from China's NMPA for YUPELRI® (revefenacin), the first once-daily nebulized LAMA for COPD maintenance treatment in China.
The approval triggers a $7.5 million milestone payment to TBPH, with potential for additional sales-based milestones up to $37.5 million and tiered royalties of 14% to 20% on net sales in China. Viatris will handle all commercialization aspects.
TBPH's financial position includes $131 million in cash, $225 million from TRELEGY royalties sale to GSK, 35% of U.S. YUPELRI profits, and up to $150 million in potential TRELEGY milestone payments.
Theravance Biopharma (NASDAQ:TBPH) ha annunciato che il suo partner Viatris ha ottenuto l'approvazione dalla NMPA cinese per YUPELRI® (revefenacina), il primo LAMA nebulizzato da assumere una volta al giorno per il trattamento di mantenimento della BPCO in Cina.
Questa approvazione comporta un pagamento milestone di 7,5 milioni di dollari a favore di TBPH, con la possibilità di ulteriori traguardi legati alle vendite fino a 37,5 milioni di dollari e royalties a scaglioni dal 14% al 20% sulle vendite nette in Cina. Viatris si occuperà di tutti gli aspetti commerciali.
La posizione finanziaria di TBPH comprende 131 milioni di dollari in contanti, 225 milioni di dollari derivanti dalla vendita delle royalties di TRELEGY a GSK, il 35% dei profitti di YUPELRI negli Stati Uniti e fino a 150 milioni di dollari in potenziali pagamenti milestone di TRELEGY.
Theravance Biopharma (NASDAQ:TBPH) anunció que su socio Viatris ha recibido la aprobación de la NMPA de China para YUPELRI® (revefenacina), el primer LAMA nebulizado de una vez al día para el tratamiento de mantenimiento de la EPOC en China.
Dicha aprobación activa un pago por hito de 7,5 millones de dólares a TBPH, con potencial para pagos adicionales basados en ventas de hasta 37,5 millones de dólares y regalías escalonadas del 14% al 20% sobre las ventas netas en China. Viatris se encargará de todos los aspectos comerciales.
La posición financiera de TBPH incluye 131 millones de dólares en efectivo, 225 millones de dólares provenientes de la venta de regalías de TRELEGY a GSK, el 35% de las ganancias de YUPELRI en EE. UU. y hasta 150 millones de dólares en posibles pagos por hitos de TRELEGY.
Theravance Biopharma (NASDAQ:TBPH)는 파트너사 Viatris가 중국 NMPA로부터 YUPELRI® (revefenacin)의 승인을 받았다고 발표했습니다. 이는 중국에서 만성 폐쇄성 폐질환(COPD) 유지 치료를 위한 최초의 하루 한 번 분무형 LAMA입니다.
이번 승인은 TBPH에 750만 달러의 마일스톤 지급을 촉발하며, 추가 매출 기반 마일스톤으로 최대 3,750만 달러와 중국 내 순매출에 대한 14%에서 20%의 계층별 로열티 지급 가능성이 있습니다. Viatris가 모든 상업화 업무를 담당합니다.
TBPH의 재무 상태에는 1억 3,100만 달러 현금, GSK에 대한 TRELEGY 로열티 판매로부터의 2억 2,500만 달러, 미국 내 YUPELRI 수익의 35%, 그리고 최대 1억 5,000만 달러의 TRELEGY 마일스톤 지급 가능성이 포함됩니다.
Theravance Biopharma (NASDAQ:TBPH) a annoncé que son partenaire Viatris a obtenu l'approbation de la NMPA chinoise pour YUPELRI® (revefenacine), le premier LAMA nébulisé à dose quotidienne unique pour le traitement d'entretien de la BPCO en Chine.
Cette approbation déclenche un paiement d'étape de 7,5 millions de dollars à TBPH, avec un potentiel de paiements supplémentaires basés sur les ventes pouvant atteindre 37,5 millions de dollars et des redevances échelonnées de 14 % à 20 % sur les ventes nettes en Chine. Viatris prendra en charge tous les aspects de la commercialisation.
La position financière de TBPH comprend 131 millions de dollars en liquidités, 225 millions de dollars issus de la vente des redevances TRELEGY à GSK, 35 % des bénéfices de YUPELRI aux États-Unis, ainsi que jusqu'à 150 millions de dollars de paiements d'étapes potentiels pour TRELEGY.
Theravance Biopharma (NASDAQ:TBPH) gab bekannt, dass sein Partner Viatris die Zulassung der chinesischen NMPA für YUPELRI® (Revefenacin) erhalten hat, das erste einmal täglich vernebelte LAMA zur COPD-Erhaltungstherapie in China.
Die Zulassung löst eine Meilensteinzahlung in Höhe von 7,5 Millionen US-Dollar an TBPH aus, mit der Möglichkeit zusätzlicher umsatzabhängiger Meilensteinzahlungen von bis zu 37,5 Millionen US-Dollar sowie gestaffelter Lizenzgebühren von 14% bis 20% auf den Nettoumsatz in China. Viatris übernimmt alle Vermarktungsaktivitäten.
Die finanzielle Lage von TBPH umfasst 131 Millionen US-Dollar in bar, 225 Millionen US-Dollar aus dem Verkauf von TRELEGY-Royalties an GSK, 35 % der US-Gewinne von YUPELRI sowie bis zu 150 Millionen US-Dollar potenzielle Meilensteinzahlungen für TRELEGY.
- First once-daily nebulized LAMA approval in China for COPD treatment
- Immediate $7.5 million milestone payment from Viatris
- Potential for additional $37.5 million in sales-based milestones
- Tiered royalties of 14-20% on China net sales with no commercial costs
- Strong cash position of $131 million plus recent $225 million from TRELEGY royalties sale
- None.
Insights
YUPELRI's China approval strengthens Theravance's financial position with immediate $7.5M payment and future royalties without commercial costs.
The approval of YUPELRI in China represents a significant regulatory achievement for Theravance Biopharma, establishing the drug as the first once-daily nebulized LAMA treatment for COPD in the world's largest potential COPD market. China has over 100 million COPD patients, creating substantial commercial opportunity.
The financial structure of this deal is particularly advantageous. Theravance receives an immediate $7.5 million milestone payment expected in Q3 2025, with potential for additional sales milestones up to $37.5 million and tiered royalties between 14-20% on net sales. Critically, Theravance bears zero commercialization costs in China, as Viatris handles all aspects of launch and marketing.
This approval strengthens Theravance's already improving financial position, which includes $131 million cash on hand (as of March 31, 2025), $225 million from the recent TRELEGY royalties sale, 35% of U.S. YUPELRI profits, and potential TRELEGY milestone payments up to $150 million. The diversified revenue streams provide stability while the company advances ampreloxetine, its wholly-owned candidate for neurogenic orthostatic hypotension in multiple system atrophy, which is nearing completion of enrollment in its registrational CYPRESS study.
The risk-reward profile here is compelling - Theravance gains significant upside exposure to the Chinese COPD market without assuming commercial risk or infrastructure costs, while building a stronger financial foundation for its rare disease pipeline development.
- YUPELRI approved by
China's NMPA as the first once-daily nebulized LAMA for maintenance treatment of COPD - Approval triggers
$7.5 million China - Theravance Biopharma incurs no commercial costs in
China ; Viatris is responsible for the launch and commercialization
This approval triggers a one-time
Today's announcement offers further support for Theravance Biopharma's diversified and improving financial position, which includes
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 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 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 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 payments, the ability to provide value to shareholders, the Company's regulatory strategies and timing of clinical studies, 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 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 May 12, 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.
Contact:
investor.relations@theravance.com
650-808-4045
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SOURCE Theravance Biopharma, Inc.
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