Company: MYGN
Filing Date: 2025-11-04
Form Type: 10-Q
Source: 0000899923-25-000112
Chunk: 56

Company: MYRIAD GENETICS INC
Filing Date: 2025-11-04
Form: 10-Q
Item: Part II, Item 1A
Chunk 56
---
 and the ability of our employees to respond quickly and effectively to strategic projects and changes in our operations and business practices. The implementation of our strategic plan has resulted, and is expected to continue to result, in changes to business priorities and operations, capital allocation priorities, operational and organizational structures, and increased demands on management. The execution of our strategic plan may take longer than anticipated, and we may not realize, in full or part, our anticipated growth targets in our testing volumes and revenue, or such growth may be realized more slowly than anticipated.

In recent years we have not operated our business profitably, and we may not be able to achieve or maintain profitability in the future.  Potential events or factors that may have a significant impact on our ability to achieve our growth targets and achieve and/or maintain revenue growth and profitability for our business include the following:

•the efforts of third-party payors to limit or decrease the amounts that they are willing to pay for our tests, recoup amounts already paid, not cover our tests, or institute burdensome administrative requirements for reimbursement, such as prior authorization requirements;

•our ability to execute on our strategic plan;

•increased costs of reagents and other consumables required for testing;

•increased personnel and facility costs;

•our inability to hire competent, trained staff, including laboratory directors required to review and approve all reports we issue in our business, and sales personnel;

•our inability to obtain necessary equipment or reagents to perform testing;

•our inability to increase production capacity to meet demand increases;

•our inability to expand into new markets;

•increased licensing or royalty costs, and our ability to maintain and enforce the intellectual property rights underlying our tests and services;

31

Table of Contents

•changes in intellectual propriety law applicable to our patents or enforcement in the United States and foreign countries;

•the expiration of the patents covering our products;

•potential obsolescence of our tests;

•our inability to obtain or increase commercial acceptance of our tests;

•increased competition and loss of market share;

•global or local economic conditions;

•protectionist laws and business practices, including trade restrictions, tariffs, export controls, quotas and other trade barriers, including China-U.S., Mexico-U.S. and Canada-U.S trade policies;

•increased regulatory requirements; 

•material litigation costs, settlements, and judgments;

•our increased investment in research and development, including the possibility that new products may fail to achieve clinical validation, regulatory clearance, or market acceptance; and

•our inability to successfully