MINNEAPOLIS, May 04, 2021 (GLOBE NEWSWIRE) -- Inspire Medical Systems, Inc. (NYSE:INSP) ("Inspire"), a medical technology company focused on the development and commercialization of innovative and minimally invasive solutions for patients with obstructive sleep apnea, today reported financial results for the quarter ended March 31, 2021.
Recent Business Highlights
- Generated revenue of $40.4 million in the first quarter of 2021, an 89% increase over the same quarter last year
- Reported gross margin of 85.2% in the first quarter of 2021, an increase over the 84.6% reported in the same quarter last year
- Activated 47 new centers in the U.S. in the first quarter of 2021, bringing the total to 472 U.S. medical centers implanting Inspire therapy
- Created 10 new U.S. sales territories in the first quarter of 2021, bringing the total to 117 U.S. sales territories
- Received U.S. Food and Drug Administration ("FDA") approval for the Inspire two-incision implant procedure, which significantly reduces the surgical procedure time and announces CE Mark approval for Europe of the two-incision implant procedure today
- Received FDA approval of new physician programmer platform and commenced commercial launch
- Entered into exclusive distribution agreement with Japan Lifeline Co., Ltd ("JLL") to commercialize Inspire therapy in Japan, following successful completion of reimbursement review of Inspire therapy by the Minister of Health Labour and Welfare ("MHLW")
"We continued to execute on our key commercial initiatives during the first quarter," said Tim Herbert, President and Chief Executive Officer of Inspire Medical Systems. "We did experience the expected seasonality early in the first quarter of 2021 due to high deductible insurance plans resetting as well as the resurgence of COVID-19 in certain geographies, but the team performed extremely well to overcome these challenges. Our growth in the quarter was primarily driven by the increased number of procedures occurring at existing centers, as well as the continued addition of new implanting centers and territory managers. Based on our strong performance in the first quarter and the anticipated continuation of positive implant growth trends in 2021, we are raising our full year 2021 revenue guidance to between $192 million to $196 million, an increase from our prior guidance of $183 million to $188 million."
First Quarter 2021 Financial Results
Revenue was $40.4 million for the three months ended March 31, 2021, an 89% increase from $21.3 million in the corresponding period in the prior year. U.S. revenue for the quarter was $37.8 million, an increase of 96% as compared to the prior year quarter. First quarter European revenue was $2.6 million, an increase of 25% as compared to the first quarter of 2020.
Gross margin increased to 85.2% for the three months ended March 31, 2021, compared to 84.6% for the corresponding prior year period, with the improvement primarily due to manufacturing efficiencies and higher sales volume.
Operating expense increased to $50.1 million for the first quarter of 2021, as compared to $34.5 million in the corresponding prior year period, an increase of 45%. This planned increase primarily reflected ongoing investments in the expansion of the U.S. and European sales organizations, direct-to-patient marketing programs, and continued product development efforts, as well as increased general corporate costs.
Net loss was $16.2 million for the first quarter of 2021, consistent with the corresponding prior year period. The diluted net loss per share for the first quarter of 2021 was $0.60 per share, as compared to $0.67 in the prior year period.
As of March 31, 2021, cash, cash equivalents and investments were $226.1 million, compared to $234.4 million at December 31, 2020.
Full Year 2021 Guidance
Given the positive trends during the first quarter, Inspire is increasing its full year 2021 revenue guidance to between $192 million to $196 million, which would represent growth of approximately 66% to 70% over full year 2020 revenue of $115.4 million. Gross margin for full year 2021 is now anticipated to be in the range of 84% to 85%. This compares to the prior revenue guidance of $183 million to $188 million and gross margin guidance of 83% to 85%.
In addition, Inspire is increasing its guidance around the opening of new U.S. medical centers to a range of 36 to 40 per quarter for the remainder of the year, as compared to the prior guidance of 34 to 38 centers. The Company is maintaining its guidance of adding eight to nine new territories per quarter in 2021.
Webcast and Conference Call
Inspire's management will host a conference call after market close today, Tuesday, May 4, 2021, at 5:00 p.m. Eastern Time to discuss these results and answer questions.
To listen to a live webcast, please visit the Investors section of the Inspire website at www.inspiresleep.com. The webcast replay will be available on the Inspire website for two weeks following the completion of the call.
About Inspire Medical Systems
Inspire is a medical technology company focused on the development and commercialization of innovative and minimally invasive solutions for patients with obstructive sleep apnea. Inspire's proprietary Inspire therapy is the first and only FDA-approved neurostimulation technology that provides a safe and effective treatment for moderate to severe obstructive sleep apnea.
For additional information about Inspire, please visit www.inspiresleep.com.
Forward Looking Statements
Investor & Media Contact:
Bob Yedid
LifeSci Advisors
646-597-6989
[email protected]
INSPIRE MEDICAL SYSTEMS, INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited)
(in thousands, except share and per share amounts)
INSPIRE MEDICAL SYSTEMS, INC.
BALANCE SHEETS (Unaudited)
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