Company: CNTB
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001835268-25-000014
Chunk: 120

Company: Connect Biopharma Holdings Ltd
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 120
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 off-label uses, we may become subject to significant liability. The U.S. federal government has levied large civil and criminal fines against companies for alleged improper promotion of off-label use and has enjoined several companies from engaging in off-label promotion. The government has also required companies to enter into consent decrees requiring, among other things, substantial additional personnel resources to manage, or has imposed permanent injunctions under which specified promotional conduct is changed or curtailed. If we cannot successfully manage the promotion of our Product Candidates, if approved, we could become subject to significant liability, which would materially adversely affect our business and financial condition.

The commercial success of our Product Candidates will depend upon the degree of market acceptance of such Product Candidates by physicians, patients, healthcare payors and others in the medical community.

Our Product Candidates may not be commercially successful. Even if any of our Product Candidates receive regulatory approval, they may not gain market acceptance among physicians, patients, healthcare payors or others in the medical community. The commercial success of any of our current or future Product Candidates will depend significantly on the broad adoption and use of the resulting product by physicians and patients for approved indications. The degree of market acceptance of our products, if approved for commercial sale, will depend on a number of factors, including:

•demonstration of clinical efficacy and safety compared to other more established products;

•the indications for which our Product Candidates are approved;

•the limitation of our targeted patient population and other limitations or warnings contained in any regulatory authority-approved labeling;

•the prevalence and severity of the diseases and any side effects;

•the convenience and ease of administration;

•the acceptance of a new drug or biologic for the relevant indication by healthcare providers and their patients;

•the reimbursement, pricing and cost-effectiveness of our products, as well as the cost of treatment with our products in relation to alternative treatments and therapies;

•our ability to obtain and maintain sufficient third-party coverage and adequate reimbursement from government healthcare programs, including Medicare and Medicaid, private health insurers and other third-party payors;

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•the willingness of patients to pay all, or a portion of, out-of-pocket costs in the absence of coverage and adequate reimbursement by third-party payors and government authorities;

•any restrictions on the use of our products, and the prevalence and severity of any adverse effects;

•the success of our physician education programs;

•the timing of market introduction of our products as well as competitive drugs;

•potential product liability claims;

•the availability of alternative effective treatments for the disease indications