Company: TBPH
Filing Date: 2025-08-13
Form Type: 10-Q
Source: 0001558370-25-011408
Chunk: 1

Company: Theravance Biopharma, Inc.
Filing Date: 2025-08-13
Form: 10-Q
Item: Part II, Item 1A
Chunk 1
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ITEM 1A.  RISK FACTORS

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The risks described below and elsewhere in this Quarterly Report on Form 10-Q and in our other public filings with the SEC are not the only risks facing us. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition and/or operating results.

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Summary of Principal Risks Associated with Theravance Biopharma’s Business 

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●We may never achieve or sustain profitability from our operations;

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●If YUPELRI’s acceptance by physicians, patients, third-party payors, or the medical community in general does not continue to grow, we may not receive significant additional revenues from sales of this product;

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●In collaboration with Viatris, we are responsible for marketing and sales of YUPELRI in the US, which subjects us to certain risks;

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●Any delay in commencing or completing clinical studies for product candidates or product and any adverse results from clinical or non-clinical studies or regulatory obstacles product candidates or product may face, would harm our business and the price of our securities could fall;

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●If our product candidates are not approved by regulatory authorities, including the FDA, we will be unable to commercialize them;

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●If our partners do not satisfy their obligations under our agreements with them, or if they terminate our partnerships with them, we may not be able to develop or commercialize our partnered product candidates as planned; 

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●Our ongoing drug development efforts might not generate additional approvable drugs;

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●We face substantial competition from companies with more resources and experience than we have, which may result in others discovering, developing, receiving approval for or commercializing products before or more successfully than we do;

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●We are subject to extensive and ongoing regulation, oversight and other requirements by the FDA and failure to comply with these regulations and requirements may subject us to penalties that may adversely affect our financial condition or our ability to commercialize any approved products; and

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●We and/or our collaboration partners and those commercializing products with respect to which we have an economic interest or right to receive royalties may face competition from companies seeking to market generic versions of any approved products in which we have an interest, such as YUPELRI.

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