Company: KROS
Filing Date: 2025-05-06
Form Type: 10-Q
Source: 0001664710-25-000046
Chunk: 30

Company: Keros Therapeutics, Inc.
Filing Date: 2025-05-06
Form: 10-Q
Item: Item 1A
Chunk 30
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 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 cibotercept, 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. 

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 materially harmed. 

We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.

The biopharmaceutical industry is characterized by intense competition and rapid innovation. Our competitors may be able to develop other compounds or drugs that are able to achieve similar or better results. Our potential competitors include major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies and universities and other research institutions. Many of our competitors have substantially greater financial, technical and other resources, such as larger research and development staff and experienced marketing and manufacturing organizations and