YUPELRI cleared by NMPA, opens COPD market for Theravance Biopharma

Rhea-AI Filing Summary

Theravance Biopharma (NASDAQ: TBPH) filed an 8-K disclosing that China’s NMPA approved YUPELRI (revefenacin), the first once-daily nebulized LAMA for COPD in China.

The decision triggers a $7.5 million one-time milestone payment from partner Viatris, expected in Q3 2025, and entitles Theravance to additional sales-based milestones and tiered royalties on Chinese net sales. Viatris will fund and manage all development and commercialization activities.

No other financial statements were furnished; the disclosure is limited to Item 8.01 and Exhibit 99.1.

Positive

• NMPA approval of YUPELRI opens access to China's large COPD market
• One-time $7.5 million milestone payment due Q3 2025, with additional royalty potential

Negative

• None.

Insights

Pharmaceutical Commercialization Analyst

TL;DR: China nod unlocks milestone cash and future royalty upside.

NMPA approval adds a high-value market for YUPELRI. The immediate $7.5 m cash (~3-4 % of 2024 revenue) arrives without incremental spend because Viatris bears launch costs. With ~100 m COPD patients in China, uptake could materially extend the product’s lifecycle and diversify Theravance’s revenue mix. Regulatory success in a stringent jurisdiction also strengthens ex-US partnering leverage. Key watch points: formulary access, pricing, and sales ramp pace.

Financial Analyst

TL;DR: Modest near-term boost; long-term value depends on China sales.

The milestone improves Q3 liquidity and extends cash runway by roughly one quarter at current burn rates. Assuming mid-single-digit royalties, a conservative 5 % cut of $100 m peak sales would add about $5 m annually—helpful but not transformative. The non-dilutive structure preserves margins and reduces financing risk. Guidance remains unchanged; valuation uplift stems from higher probability-weighted NPV for YUPELRI.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC  20549

FORM 8-K

Current Report Pursuant

to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event Reported): June 10, 2025

THERAVANCE BIOPHARMA, INC.

(Exact Name of Registrant as Specified in its Charter)

Cayman Islands		001-36033		98-1226628
(State or Other Jurisdiction of		(Commission File Number)		(I.R.S. Employer Identification
Incorporation)				Number)

c/o Theravance Biopharma US, LLC

901 Gateway Boulevard

South San Francisco, CA 94080

(650) 808-6000

(Addresses, including zip code, and telephone numbers, including area code, of principal executive offices)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

¨  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Ordinary Share $0.00001 Par Value		TBPH		NASDAQ Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company    ¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 8.01 Other Events

On June 26, 2025, Theravance Biopharma, Inc. (“Theravance Biopharma” or the “Company”) (NASDAQ: TBPH) announced that Viatris, Inc. (“Viatris”) has secured regulatory approval from China’s National Medical Products Administration (NMPA) for YUPELRI^® (revefenacin) inhalation solution, the first once-daily nebulized long-acting muscarinic antagonist (LAMA) approved for maintenance treatment of chronic obstructive pulmonary disease (COPD) in China.

This approval triggers a one-time $7.5 million milestone from Viatris to Theravance, which is expected to be received in Q3 2025. Theravance is also eligible for further sales-based milestones and tiered royalties on net sales in China. Viatris is responsible for all aspects of development and commercialization of YUPELRI in China.

A copy of the press release is furnished as Exhibit 99.1 to this Current Report.

The information in this Current Report (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. The information in this Current Report (including Exhibit 99.1) shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

99.1		Press Release dated June 26, 2025
104		Cover Page Interactive Data File (cover page XBRL tags embedded within the Inline XBRL document)

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	THERAVANCE BIOPHARMA, INC.
Date: June 26, 2025	By:	/s/ Aziz Sawaf
		Aziz Sawaf
		Senior Vice President and Chief Financial Officer

FAQ

How much will TBPH receive from Viatris after YUPELRI's China approval?

The filing states a $7.5 million one-time milestone payment, expected in Q3 2025.

What product did China approve for Theravance Biopharma ([[SYMBOL]])?

China's NMPA approved YUPELRI (revefenacin) inhalation solution for maintenance treatment of COPD.

Who will commercialize YUPELRI in China according to the 8-K?

Viatris, Inc. is responsible for all development and commercialization activities in China.

Will Theravance earn additional royalties from YUPELRI sales in China?

Yes. The company is eligible for sales-based milestones and tiered royalties on net sales.

Did the 8-K include any updated financial statements for TBPH?

No. The report is limited to Item 8.01; no financial statements were furnished.