Company: MIRA
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001183
Chunk: 13

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 13
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 levels, our 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 we obtain coverage for products we may market, the resulting reimbursement
payment rates may require co-payments that patients find unacceptably high. Patients may not use our products if coverage is not provided,
or reimbursement is inadequate to cover a significant portion of their cost.

In
addition, the market for our 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 our 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 our products
at less than an optimized price could impact our revenues and overall success as a company. It will be difficult to determine the optimized
price for our 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 our 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 us to provide scientific and clinical support for
the use of our products to each payer separately, with no assurance that coverage will be obtained. If we are unable to obtain coverage
of, and adequate payment levels for, products we may market to third-party payers, physicians may limit how much or under what circumstances