Company: INSP
Filing Date: 2025-05-05
Form Type: 10-Q
Source: 0001609550-25-000020
Chunk: 45

Company: Inspire Medical Systems, Inc.
Filing Date: 2025-05-05
Form: 10-Q
Item: Part I, Item 1
Chunk 45
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, including clinical and regulatory initiatives to obtain marketing approval, and sales and marketing activities. For the three months ended March 31, 2025, we generated revenue of $201.3 million with a gross margin of 84.7% and had a net income of $3.0 million compared to revenue of $164.0 million with a gross margin of 84.9% and a net loss of $10.0 million for the three months ended March 31, 2024. Our accumulated deficit as of March 31, 2025 was $288.9 million.

We have invested heavily in product development. Our research and development activities have been centered on driving continuous improvements to our Inspire therapy. We have also made significant investments in clinical studies to demonstrate the safety and efficacy of our Inspire therapy and to support regulatory submissions. We continue to make investments in research and development efforts to develop our future generations of Inspire systems and support our future regulatory submissions for expanded indications and for new markets such as additional European countries and the Asia Pacific region. For example, in August 2024, we received approval from the FDA for our next generation Inspire system ("Inspire V"), which we expect to fully launch in the U.S. in 2025. 

Beginning late in the first quarter and continuing into the second quarter of 2025, in connection with awareness gained during our ongoing limited market release of the Inspire V system, we began to observe that some patients and physicians are delaying Inspire therapy until Inspire V is available at their location. Additionally, beginning late in the first quarter and continuing into the second quarter of 2025, we began to observe that some of our customers are using their existing inventory of our Inspire IV system ("Inspire IV") prior to purchasing Inspire V systems. While we cannot quantify the impact at this time or predict if these patterns may change, we anticipate that the occurrence of patients and physicians delaying Inspire therapy until Inspire V is available and the destocking by some of our customers of their existing Inspire IV inventory may impact our consolidated revenue until Inspire V is fully launched and our customers have used their existing Inspire IV inventory, which is expected to primarily occur in the second quarter of 2025. We plan to continue to make Inspire IV systems available in the U.S. after the Inspire V launch as inventory levels allow, and outside the U.S., subject to our receiving the appropriate regulatory clearances for Inspire V in foreign markets.