Company: INGN
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0000950170-25-029993
Chunk: 155

Company: Inogen Inc
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1A
Chunk 155
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 litigation;

•our dependence on the services of our senior executives and other key technical personnel;

•variance in our financial condition and results of operations; 

•the market opportunities for our products; and

•our ability to maintain effective internal controls.

 21

Risks related to the regulatory environment:

•extensive federal, state, and international regulations related to our business by numerous government agencies, including the FDA and the MDR;

•the potential need to seek additional clearances or approvals for our products; and

•potential FDA, state, or international regulatory enforcement action and other penalties.

Risks related to our intellectual property:

•our ability to secure and maintain patent or other intellectual property protection for the intellectual property used in our products;

•the possibility that any of our patents may be challenged, invalidated, circumvented or rendered unenforceable; and

•patent and other intellectual property litigation if our products infringe or appear to infringe the intellectual property rights of others.

Risks related to our common stock:

•the volatility of the trading price of our common stock;

•potential sales of a large number of shares of our common stock; and

•anti-takeover provisions in our charter documents and under Delaware law.

Risks related to our business and strategy

We operate in a highly competitive industry and we may be unable to compete effectively.

The respiratory market, including long-term oxygen therapy market, is highly competitive. We compete with a number of manufacturers and distributors of POCs, as well as providers of other long-term oxygen therapy solutions such as home delivery of oxygen tanks or cylinders, stationary concentrators, transfilling concentrators, and liquid oxygen. 

The market is subject to rapid change resulting from technological advances, innovations and scientific discoveries. In the product lines in which we compete, we face a range of competitors from large companies with multiple business lines to small, specialized manufacturers that offer a limited selection of niche products. Development by other companies of new or improved products, processes, technologies, or the introduction of reprocessed products or low-cost versions of products similar to ours may make our existing or planned products less competitive. In addition, we face competition from providers of alternative medical therapies, such as pharmaceutical companies.

 Given the relatively straightforward regulatory path in the oxygen therapy device manufacturing market, we expect that the industry will become increasingly competitive in the future. For example, some of our major competitors have implemented direct-to-consumer sales models, which may increase their competitiveness and sales to patients, and we have recently seen the