Company: MIRM
Filing Date: 2025-05-07
Form Type: 10-Q
Source: 0001759425-25-000032
Chunk: 227

Company: Mirum Pharmaceuticals, Inc.
Filing Date: 2025-05-07
Form: 10-Q
Item: Part II, Item 1A
Chunk 227
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 payors. For example, failure to submit monthly/quarterly AMP and best price data on a timely basis could result in significant civil monetary penalties for each day the submission is late beyond the due date. Failure to make necessary disclosures and/or to identify overpayments could result in allegations against us under the civil False Claims Act and other laws and regulations. Any required refunds to the U.S. government or responding to a government investigation or enforcement action would be expensive and time consuming and could have a material adverse effect on our business, results of operations and financial condition. In addition, in the event that the CMS were to terminate our rebate agreement, no federal payments would be available under Medicaid or Medicare for our covered outpatient drugs.

We may face product liability exposure, and if claims are brought against us, we may incur substantial liability if our insurance coverage for those claims is inadequate.

We face an inherent risk of product liability suits for our approved medicines and product candidates. Our approved medicines and our product candidates are designed to affect important bodily functions and processes. Any side effects, manufacturing defects, failure to follow instructions, misuse or abuse associated with our approved medicines or our product candidates could result in injury to a patient or even death. In addition, a liability claim may be brought against us even if our approved medicines or our product candidates merely appear to have caused an injury. Product liability claims may be brought against us by, among others, consumers, their family members, healthcare providers, pharmaceutical companies or others selling or otherwise coming into contact with our approved medicines or product candidates. If we are the target of product liability claims, we will incur substantial legal costs, potential liabilities and could incur reputational harm if we do not successfully defend ourselves. 

In addition, regardless of merit or eventual outcome, product liability claims may result in, among other things:

•the inability to commercialize our approved medicines or product candidates, if approved;

•decreased demand for our approved medicines or product candidates; 

•termination of clinical trial sites or entire trial programs; 

•product recall or withdrawal from the market or labeling, marketing or promotional restrictions;

•impairment of our business reputation and negative media attention;

•substantial costs of any related litigation or similar disputes;

•distraction of management’s attention and other resources and employees from our primary business;

•substantial monetary awards to patients or other claimants against us that may not be covered by insurance; and

•loss of revenue.

Large judgments have been awarded in class action and individual lawsuits based on drugs that had anticipated or