Company: IPHYF
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001598599-25-000042
Chunk: 20

Company: Innate Pharma SA
Filing Date: 2025-04-30
Form: 20-F
Item: Item 3
Chunk 20
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 on the profitability of the company placing the medicinal product on the market. There can be no assurance that any country that has price controls or reimbursement limitations for biopharmaceutical products will allow favorable reimbursement and pricing arrangements for any of Innate's products. Historically, biopharmaceutical products launched in the European Union do not follow price structures of the United States and generally tend to have significantly lower prices.

The Company believes that pricing pressures will continue and may increase, which may make it difficult for it to sell any of its product candidates that may be approved in the future at a price acceptable to the Company or any of its existing or future collaborators.

Any of the Company's product candidates, if approved and commercialized, may fail to achieve market acceptance by physicians, patients, third-party payors or the medical community to a degree that is necessary for commercial success.

Even if the medical community accepts a product as safe and efficacious for its indicated use, physicians may choose to restrict the use of the product if the Company is unable to demonstrate that, based on experience, clinical data, side-effect profiles and other factors, its drug is preferable to any existing drugs

or treatments. The Company cannot predict the degree of market acceptance of any product candidate that will receive marketing authorization, which will depend on a number of factors, including, but not limited to:

• the demonstration of the clinical efficacy and safety of the drug;

• the approved labeling for the drug and any required warnings;

• prevalence and severity of adverse side effects;

• the advantages and disadvantages of the drug compared to alternative treatments;

• ease of the drug’s use;

• its ability to educate the medical community about the safety and effectiveness of the drug;

• the scope of any approval provided by the FDA or foreign regulatory authorities;

• publicity about its product or about competitive products;

• the coverage and reimbursement policies of government and commercial third-party payors pertaining to the drug;

• the market price of its drugs relative to competing treatments; and

• due to the rarity of orphan diseases, it could be difficult finding patients seeking treatment.

Poor market penetration could have an adverse effect on the Company's business, prospects, financial condition and results of operations.

Even if some of its product candidates receive marketing authorization, the terms of such approval, ongoing regulation and potential post-marketing restrictions or withdrawal from the market may limit how the drug may be marketed and may subject the Company to penalties for failure to comply with regulatory requirements, which could impair its ability to generate revenues.

Even if any of its product candidates receives