Company: MIRM
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001759425-25-000014
Chunk: 107

Company: Mirum Pharmaceuticals, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1A
Chunk 107
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57 to a high of $53.16. In addition to the factors discussed in this “Risk Factors” section, these factors include, among others:

•the degree of physician and patient adoption of our approved medicines and use of our approved medicines necessary for commercial success;

•our failure to grow and maintain our own sales force to market our approved medicines;

•our ability to market and sell our approved medicines, where approved;

•any delay in our regulatory filings for Livmarli, Ctexli or volixibat and any adverse development or perceived adverse development with respect to the applicable regulatory authority’s review of such filings, including without limitation the FDA’s issuance of a “refusal to file” letter or a request for additional information;

•our ability to scale our distribution capabilities;

•any delay in our regulatory filings for our product candidates and any adverse development or perceived adverse development with respect to the applicable regulatory authority’s review of such filings, including without limitation the FDA’s issuance of a “refusal to file” letter or a request for additional information;

•our failure to commercialize our product candidates;

•the commencement, enrollment or results of our ongoing clinical trials of our product candidates or any future clinical trials we may conduct, or changes in the development status of our product candidates;

•adverse results or delays in clinical trials;

•our decision to initiate a clinical trial, not to initiate a clinical trial or to terminate an existing clinical trial; 

•adverse regulatory decisions, including failure to receive regulatory approval for our product candidates;

•changes in laws or regulations applicable to our approved medicines and our product candidates, including but not limited to clinical trial requirements for approvals;

•changes in the structure of health care payment systems;

•the failure to obtain coverage and adequate reimbursement of our approved medicines and our product candidates, if approved;

•adverse developments concerning our manufacturers;

•our inability to obtain adequate product supply for any approved drug product or inability to do so at acceptable prices;

•our inability to maintain or establish collaborations if needed;

•our ability to in-license, acquire, develop and market additional product candidates or approved medicines;

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•management transitions and additions or departures of key scientific or management personnel;

•unanticipated serious safety concerns related to the use of our approved medicines or our product candidates;

•introduction of new products or services offered by us or our competitors; 

•announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;

•our ability to effectively manage