Company: KROS
Filing Date: 2025-11-05
Form Type: 10-Q
Source: 0001664710-25-000089
Chunk: 352

Company: Keros Therapeutics, Inc.
Filing Date: 2025-11-05
Form: 10-Q
Item: Item 8
Chunk 352
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 community necessary for commercial success. The revenues that we generate from their sales may be limited, and we may never become profitable. 

We have never commercialized a product candidate for any indication. Even if our product candidates are approved by the appropriate regulatory authorities for marketing and sale, they may not gain acceptance among physicians, patients, third-party payors and others in the medical community. If any product candidates for which we obtain regulatory approval does not gain an adequate level of market acceptance, we could be prevented from or significantly delayed in achieving profitability. Market acceptance of our product candidates by the medical community, patients and third-party payors will depend on a number of factors, some of which are beyond our control. For example, physicians are often reluctant to switch their patients and patients may be reluctant to switch from existing therapies even when new and potentially more effective or safer treatments enter the market. 

Efforts to educate the medical community and third-party payors on the benefits of our product candidates may require significant resources and may not be successful. If any of our product candidates are approved but do not achieve an adequate level of market acceptance, we could be prevented from or significantly delayed in achieving profitability. The degree of market acceptance of any product for which we receive marketing approval will depend on a number of factors, including:

■the clinical indications for which our product candidates are approved; 

■physicians, hospitals and patients considering our product candidates as a safe and effective treatment; 

■the potential and perceived advantages of our product candidates over alternative treatments; 

■the prevalence and severity of any side effects; 

■product labeling or product insert requirements of the FDA or comparable foreign regulatory authorities; 

■limitations or warnings contained in the labeling approved by the FDA or comparable foreign regulatory authorities; 

■the timing of market introduction of our product candidates in relation to other potentially competitive products; 

■the cost of our product candidates in relation to alternative treatments; 

■the amount of upfront costs or training required for physicians to administer our product candidates; 

■the availability of coverage and adequate reimbursement from third-party payors and government authorities; 

■the willingness of patients to pay out-of-pocket in the absence of comprehensive coverage and reimbursement by third-party payors and government authorities;

■the relative convenience and ease of administration, including as compared to alternative treatments and competitive therapies; 

■the effectiveness of our sales and marketing efforts and distribution support; and 

■the presence or perceived risk of potential product liability claims. 

Enacted and future healthcare legislation may increase the difficulty and cost for