Company: KROS
Filing Date: 2025-11-05
Form Type: 10-Q
Source: 0001664710-25-000089
Chunk: 346

Company: Keros Therapeutics, Inc.
Filing Date: 2025-11-05
Form: 10-Q
Item: Item 8
Chunk 346
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 people across the EU or, if more prevalent, it must be unlikely that the marketing of the medicine would generate sufficient returns to justify the investment needed for its development.

Orphan drug designation neither shortens the development time or regulatory review time of a drug nor gives the drug any advantage in the regulatory review or approval process. While we may seek orphan drug designation for applicable indications for our current and any future product candidates, we may never receive such designations. Even if we do receive such designations, there is no guarantee that we will benefit from those designations. 

Risks Related to Commercialization of Our Product Candidates 

If we are unable to successfully commercialize any product candidate for which we receive regulatory approval, or experience significant delays in doing so, our business will be materially harmed. 

If we are successful in obtaining marketing approval from applicable regulatory authorities for KER-065, elritercept or any other product candidate, our ability to generate revenues from any such products will depend on our success in:

■launching commercial sales of such products, whether alone or in collaboration with others; 

■receiving approved labels with claims that are necessary or desirable for successful marketing, and that do not contain safety or other limitations that would impede our ability to market such products; 

■creating market demand for such products through marketing, sales and promotion activities; 

■hiring, training, and deploying a sales force or contracting with third parties to commercialize such products in the United States; 

■creating strategic collaborations with, or offering licenses to, third parties to promote and sell such products in foreign markets where we receive marketing approval; 

■manufacturing such products in sufficient quantities and at acceptable quality and cost to meet commercial demand at launch and thereafter; 

■establishing and maintaining agreements with wholesalers, distributors, and group purchasing organizations on commercially reasonable terms; 

■maintaining patent and trade secret protection and regulatory exclusivity for such products; 

■achieving market acceptance of such products by patients, the medical community, and third-party payors; 

■achieving coverage and adequate reimbursement from third-party payors for such products; 

■patients’ willingness to pay out-of-pocket in the absence of such coverage and adequate reimbursement from third-party payors; 

■effectively competing with other therapies; and 

■maintaining a continued acceptable safety profile of such products following launch. 

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To the extent we are not able to do any of the foregoing, our business, financial condition, results of operations, stock price and prospects will be