Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 68

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 68
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 and cost-containment measures, and adoption of more restrictive policies
in jurisdictions with existing controls and measures, could further limit our net revenue and results. Coverage policies and third-party
reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more products
for which a company or its collaborators receive regulatory approval, less favorable coverage policies and reimbursement rates may be
implemented in the future.

Outside the United States, ensuring adequate
coverage and payment for our product candidates will face challenges. Pricing of prescription pharmaceuticals is subject to governmental
control in many countries. Pricing negotiations with governmental authorities can extend well beyond the receipt of regulatory marketing
approval for a product and may require us to conduct a clinical trial that compares the cost effectiveness of our product candidates
or products to other available therapies. The conduct of such a clinical trial could be expensive and result in delays in our commercialization
efforts.

In the European Union, pricing and reimbursement
schemes vary widely from country to country. Some countries provide that drug products may be marketed only after a reimbursement price
has been agreed. Some countries may require the completion of additional studies that compare the cost-effectiveness of a particular
drug candidate to currently available therapies. For example, the European Union provides options for its member states to restrict the
range of drug products for which their national health insurance systems provide reimbursement and to control the prices of medicinal
products for human use. European Union member states may approve a specific price for a drug product or it may instead adopt a system
of direct or indirect controls on the profitability of the company placing the drug product on the market. Other member states allow
companies to fix their own prices for drug products, but monitor and control company profits. The downward pressure on health care costs
in general, particularly prescription drugs, has become intense. As a result, increasingly high barriers are being erected to the entry
of new products. In addition, in some countries, cross-border imports from low-priced markets exert competitive pressure that may reduce
pricing within a country. Any country that has price controls or reimbursement limitations for drug products may not allow favorable
reimbursement and pricing arrangements.

Healthcare Law and Regulation 

Healthcare providers and third-party payors play
a primary role in the recommendation and prescription of drug products that are granted regulatory approval. Arrangements with providers,
consultants, third-party payors and customers are subject to broadly applicable fraud and abuse and other healthcare laws and regulations
that may constrain our business and/or