Company: KROS
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001664710-25-000018
Chunk: 249

Company: Keros Therapeutics, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1A
Chunk 249
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 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 us to progress our clinical programs and obtain marketing approval of and commercialize our product candidates and may affect the prices we may set. 

In the United States and other jurisdictions, there have been, and we expect there will continue to be, a number of legislative and regulatory changes and proposed changes to the healthcare system that could affect our future results of operations. In particular, there have been and continue to be a number of initiatives at the U.S. federal and state levels that seek to reduce healthcare costs and improve the quality of healthcare. For example, in March 2010, the ACA was enacted, which substantially changed the way healthcare is financed by both governmental and private insurers. 

Since its enactment, there have been judicial, Congressional and executive branch challenges and amendments to certain aspects of the ACA.  For example, on August 16, 2022, the Inflation Reduction Act of 2022, or the IRA, was signed into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025.