Company: MIRA
Filing Date: 2025-06-17
Form Type: PREM14A
Source: 0001641172-25-015340
Chunk: 28

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-06-17
Form: PREM14A
Chunk 28
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 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 separately, with no assurance that coverage will be obtained. If SKNY is 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 they will prescribe or administer them, and patients may decline to purchase them. This in turn could affect SKNY’s ability to successfully commercialize products we may market, and thereby adversely impact SKNY’s profitability, results of operations, financial condition, and future success.

In addition, where SKNY has chosen to collaborate with a third party on product candidate development and commercialization, SKNY’s partner may elect to reduce the price of its products in order to increase the likelihood of obtaining reimbursement approvals. In many countries, products cannot be commercially launched until reimbursement is approved and the negotiation process in some countries can exceed 12 months. In addition, pricing and reimbursement decisions in certain countries can be affected by decisions taken in other countries, which can lead to mandatory price reductions and/or additional reimbursement restrictions across a number of other countries, which may thereby adversely affect SKNY’s sales and profitability. In the event that countries impose prices that are not sufficient to allow SKNY or its partners to generate a profit, SKNY’s partners may refuse to launch the product in such countries or withdraw the product from the market, which would adversely affect sales and profitability. Events, such as price decreases, government mandated rebates or unfavorable reimbursement decisions, could affect the pricing and reimbursement of SKNY’s products and its other product candidates and could have a material