Company: GHRS
Filing Date: 2025-07-29
Form Type: 20-F/A
Source: 0001140361-25-027850
Chunk: 67

Company: GH Research PLC
Filing Date: 2025-07-29
Form: 20-F/A
Chunk 67
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 physicians, patients, third-party payors, such as Medicare and Medicaid programs and managed care organizations in the United States, and others in the medical community. In addition, the availability of coverage and adequacy of reimbursement by third-party payors may be affected by existing and future healthcare reform measures designed to reduce the cost of healthcare. If the product candidates we develop do not achieve an adequate level of acceptance, we may not generate significant product revenues and we may not become profitable. The degree of market acceptance of any product candidate, if approved for commercial sale, will depend on a number of factors, including:

| • | efficacy and potential advantages compared to alternative treatments; |

| • | the ability to offer our products, if approved, for sale at competitive prices; |

| • | relative convenience and ease of administration compared to alternative treatments; |

| • | perceptions by the medical community, physicians, and patients, regarding the safety and effectiveness of our products and the willingness of the target patient population to try new therapies and of physicians to prescribe these 
 therapies;                                                                                                                                                                                                                            |

| • | the size of the market for such product candidate, based on the size of the patient subsets that we are targeting, in the territories for which we gain regulatory approval; |

| • | the recommendations with respect to our product candidates in guidelines published by various scientific organizations applicable to us and our product candidates; |

| • | the strength of sales, marketing and distribution support; |

| • | the timing of any such marketing approval in relation to other product approvals; |

| • | any restrictions on concomitant use of other medications; |

| • | support from patient advocacy groups; |

| • | media coverage regarding psychedelic substances; |

| • | the ability to obtain sufficient third-party coverage and adequate reimbursement from government and third-party payors; and |

| • | the prevalence and severity of any side effects. |

If government and other third-party payors do not provide coverage and adequate reimbursement levels for any products we commercialize, market acceptance and commercial success would be reduced. The successful commercialization of our product candidates in the United States will depend in part on the extent to which third-party payors, including governmental authorities and private health insurers, provide coverage and adequate reimbursement levels, as well as implement pricing policies favorable for our product candidates. Failure to obtain or maintain coverage and adequate reimbursement for our product candidates, if approved, could limit our ability to market those products and decrease our ability to generate revenue. Significant uncertainty exists as to the coverage and reimbursement status of