Company: MIRM
Filing Date: 2025-08-06
Form Type: 10-Q
Source: 0001759425-25-000041
Chunk: 225

Company: Mirum Pharmaceuticals, Inc.
Filing Date: 2025-08-06
Form: 10-Q
Item: Part II, Item 1A
Chunk 225
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 government authorities;

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•the cost of treatment in relation to alternative treatments and patients willingness to pay for our approved medicines, including relative to discretionary items;

•our ability to successfully compete with available off-label therapies, future approved therapies, and therapies in development and available for use through expanded access programs; 

•acceptance by physicians, patients, tertiary care centers, transplant centers and others in the medical community that our approved medicines are safe and effective treatments;

•physician and patient willingness to adopt a new therapy over other available therapies; 

•limitations, warnings or adverse drug reactions contained in the labeling or product inserts approved by the FDA, European Commission or comparable foreign regulatory authorities, and patients’ and physicians’ assessment of these limitations and warnings;

•overcoming any biases physicians or patients may have toward particular therapies for the treatment of the indications our approved medicines are approved for (or, if applicable, deemed medically necessary for); 

•patients and caregivers properly using our approved medicines as instructed;

•the prevalence and severity of side effects from the use or potential misuse of our approved medicines;

•relative convenience and ease of administration, including as compared to alternative treatments and competitive therapies, and patient satisfaction with the overall treatment experience;

•the ability of specialty pharmacies we contract with to process prescriptions and dispense our approved medicines and the processes required to place orders with those pharmacies;

•our ability to successfully internalize operation of our patient services hub from our third-party vendor;

•the ability of our patient services hub to provide adequate support for patients and physicians to prescribe and access our approved medicines; 

•the timing of market introduction of any of our approved medicines as well as competitive products;

•the effectiveness of our sales, marketing and distribution efforts and those of the third parties with whom we contract;

•adverse publicity about our approved medicines or favorable publicity about competitive products;

•potential product liability claims;

•our ability to manage our growth and operations to effectively support our commercialization activities; and

•patient satisfaction leading to a high percentage of patients deriving clinical benefit and staying on our approved medicines chronically.

If any of our approved medicines fail to achieve the market acceptance among physicians, patients, tertiary care centers, transplant centers or others in the medical community necessary for commercial success, our operating results and financial condition will be adversely affected, which may delay, prevent or limit our ability to generate revenue and continue our business.

Our approved medicines and our product candidates may cause undesirable side effects or have other properties that could limit their commercial profile, expose us to product liability claims, delay