Company: PACB
Filing Date: 2025-08-07
Form Type: 10-Q
Source: 0001299130-25-000156
Chunk: 109

Company: PACIFIC BIOSCIENCES OF CALIFORNIA, INC.
Filing Date: 2025-08-07
Form: 10-Q
Item: Part I, Item 8
Chunk 109
---
 and implement an effective sales and distribution strategy for our current and future products;

•develop, manufacture and commercialize new products or achieve an acceptable return on our manufacturing or research and development efforts and expenses;

•comply with regulatory requirements applicable to our products;

•anticipate and adapt to changes in our market;

•accommodate customer expectations and demands with respect to our products, increase product adoption by our existing customers or develop new customer relationships;

•deliver our early access systems to our external early access testing sites or complete our external early access testing program on our currently expected timelines;

Q2 Fiscal 2025 Form 10-Q44

•overcome unexpected challenges discovered during early access testing;

•complete the scientific and technical validation of new products on our currently expected timeline or at all;

•deliver our future products in a timely manner to our customers;

•grow our market share by marketing and selling our products for new and additional applications;

•manage the significant burdens that expanding our existing or future products into current and new markets may impose on marketing, compliance, and other administrative and managerial resources;

•maintain and develop strategic relationships with vendors, manufacturers, and other industry partners to acquire necessary materials for the production of, and to develop, manufacture and commercialize, our existing or future products;

•adapt or scale our manufacturing activities to meet performance specifications and potential demand at a reasonable cost;

•avoid infringement and misappropriation of third-party intellectual property;

•obtain and maintain any necessary licenses to third-party intellectual property on commercially reasonable terms;

•obtain valid and enforceable patents that give us a competitive advantage or enforce existing patents;

•protect our proprietary technology; and

•attract, retain, and motivate qualified personnel.

The risks noted above, especially with respect to the marketing, sales, and commercialization of our products, may be heightened by the impact of current uncertain market and other conditions. In addition, a high percentage of our expenses is and will continue to be fixed. Accordingly, if we do not generate revenue as and when anticipated, we could suffer a material adverse effect on our business, financial conditions, results of operations and prospects.

We evaluate goodwill and other intangible assets with indefinite useful lives for impairment annually and whenever events or changes in circumstances indicate that the fair value of such assets may be less than the carrying value. We also perform regular reviews to determine if any event has occurred that may indicate that the carrying values of our intangible assets with finite lives and other finite-lived assets are impaired. Events that would indicate impairment and