Company: MIRA
Filing Date: 2025-08-08
Form Type: DEFM14A
Source: 0001641172-25-022816
Chunk: 30

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-08-08
Form: DEFM14A
Chunk 30
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 acceptance of SKNY’s products could have a material adverse effect on SKNY’s business, results of operations and financial condition.

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If the price for any future approved products decreases or if government and other third-party payers do not provide coverage and adequate reimbursement levels, SKNY’s revenue and prospects for profitability will suffer.

Patients who are prescribed medicine for the treatment of their conditions generally rely on third-party payers to reimburse all or part of the costs associated with their prescription drugs. Reimbursement systems in international markets vary significantly by country and by region, and reimbursement approvals generally must be obtained on a country-by-country basis. Coverage and adequate reimbursement from governmental healthcare programs, such as Medicare and Medicaid, and commercial payers is critical to new product acceptance. Coverage decisions may depend upon clinical and economic standards that disfavor new drug products when more established or lower-cost therapeutic alternatives are already available or subsequently become available. Even if SKNY obtains coverage for products SKNY may market, the resulting reimbursement payment rates may require co-payments that patients find unacceptably high. Patients may not use SKNY’s products if coverage is not provided, or reimbursement is inadequate to cover a significant portion of their cost.

In addition, the market for SKNY’s products will depend significantly on access to third-party payers’ drug formularies or lists of medications for which third-party payers provide coverage and reimbursement. The industry competition to be included in such formularies often leads to downward pricing pressures on pharmaceutical companies. Also, third-party payers may refuse to include a particular branded drug in their formularies or otherwise restrict patient access to a branded drug when a less costly generic equivalent or other alternative is available, even if not approved for the indications for which SKNY’s products are approved.

Third-party payers or governmental or commercial entities are developing increasingly sophisticated methods of controlling healthcare costs. The current environment is putting pressure on companies to price products below what they may feel is appropriate. Selling SKNY’s products at less than an optimized price could impact its revenues and overall success as a company. It will be difficult to determine the optimized price for SKNY’s products. In addition, in the U.S., no uniform policy of coverage and reimbursement for drug products exists among third-party payers. Therefore, coverage and reimbursement for its products may differ significantly from payer to payer. As a result, the coverage determination process is often a time-consuming and costly process that will require SKNY to provide scientific and clinical support for the use of its products to each payer