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Inspire Medical Systems, Inc. Provides First Quarter and Full Year 2020 Update

Key Takeaway: Inspire Medical Systems, Inc. Provides First Quarter and Full Year 2020 Update MINNEAPOLIS, Minnesota - April 13, 2020 - Inspire Medical Systems, Inc. (NYSE: INSP) ("Inspire"), a medical technology company focused on the development and commercialization of innovative and min

Full Press Release Details

Inspire Medical Systems, Inc. Provides
First Quarter and Full Year 2020 Update
MINNEAPOLIS, Minnesota - April 13, 2020 - 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 announced preliminary unaudited
revenue for the quarter ended March 31, 2020, and the withdrawal of its full year 2020 financial guidance issued on February 25,
2020. In addition, Inspire provided an update on the actions it is taking in response to the ongoing global COVID-19 pandemic.
"The COVID-19 global health pandemic continues to cause
meaningful complications to daily life and business operations. The Inspire team is grateful to the healthcare professionals around
the world who are selflessly caring for patients on the front lines of this pandemic, and our thoughts go out to all who have been
affected," said Tim Herbert, President and Chief Executive Officer of Inspire Medical Systems.
"At Inspire, we are focused on the safety and well-being
of our employees and their families globally. In line with recommendations from federal and local government and healthcare agencies,
Inspire has transitioned employees, except for those deemed essential to key aspects of our business, to a remote work environment.
During this interim period in which surgical procedures have been significantly limited, the Inspire team is identifying and implementing
innovative solutions to support patients who have Inspire therapy, as well as continuing to educate patients who may be struggling
with their sleep apnea. Patients continue to reach out to learn more about the therapy and get connected to a healthcare provider,
and we are supporting this interaction through the use of several virtual tools and telemedicine. We continue to believe in the
strong fundamentals of our company, our safe and efficacious therapy and our proprietary technology. Moreover, we believe patients
and hospitals in the U.S. and Europe will be eager to schedule procedures once the threat of COVID-19 subsides. As such, we have
continued with our planned expansion in recruiting Territory Managers. Based on the significant number of suspended Inspire therapy
cases, a substantial portion of which we expect to be rescheduled, as well as the growing number of prior authorization approvals,
Inspire is confident that the team will be very active once circumstances allow."
First Quarter 2020 Update
Preliminary unaudited first quarter 2020 revenue is expected
to be approximately $21.3 million, a 31% increase from $16.3 million in the corresponding period in the prior year. Preliminary
unaudited first quarter 2020 U.S. revenue is expected to be approximately $19.3 million, an increase of 34% over the corresponding
period in the prior year. Preliminary unaudited first quarter 2020 European revenue is expected to be approximately $2.0 million,
an increase of 9% over the first quarter of 2019. First quarter 2020 revenue was negatively impacted by the COVID-19 pandemic.
Specifically, substantially all of our Inspire therapy procedures were postponed beginning in the second week of March and numerous
other cases, which received prior authorization approval, were not able to be scheduled and therefore were also postponed.
The Inspire prior authorization team continued to submit prior
authorization requests throughout the first quarter of 2020 with 929 submissions, or an average of 71 submissions per week. In
comparison, the team supported 722 prior authorizations in the first quarter of 2019. Further, 761 patients received an approval
of their prior authorization submission in the first quarter of 2020 in comparison to 443 approvals in the first quarter of 2019.
Inspire continued to train new U.S. medical centers and activated
28 centers in the first quarter of 2020, bringing the total to 327 U.S. medical centers implanting Inspire therapy. Additionally,
Inspire entered into an important national purchasing agreement with one of the leading health systems in the U.S., which operates
more than 150 hospitals in 20 states and the District of Columbia. This agreement provides the potential for training additional
centers later in 2020 and beyond. Further, Inspire created nine new territories during the quarter, bringing the total to 82 U.S.
territories compared to 73 as of December 31, 2019.
Inspire also added five additional insurance coverage policies
during the quarter, and now has 53 coverage policies, representing a total of approximately 165 million members under policy
in the U.S. In addition, five Medicare Administrative Contractors ("MACs") have now issued final local coverage determinations
("LCDs"), and the remaining two MACs have announced draft LCDs, which are expected to be issued as final later this
year. Along with the issued LCDs, several MACs have assigned a surgeon reimbursement of approximately $450 for the procedure to
implant the pressure sensor (add-on CPT code +0466T).
Inspire continues to engage patients through its refocused direct
to consumer marketing strategies, which included a shift from radio and TV in larger markets affected by COVID-19 towards more
digital and TV in smaller markets. Further, the team has leveraged virtual tools and telemedicine to continue physician training
and patient education.
As of March 31, 2020, Inspire had approximately $142 million
in cash, cash equivalents and investments compared to $156 million as of December 31, 2019.
Full Year 2020 Guidance
Due to the rapidly evolving healthcare
environment and continued uncertainties resulting from the impact of COVID-19, Inspire is withdrawing its previously announced
full year 2020 financial guidance, which was issued on February 25, 2020. At this date, Inspire cannot predict the extent or duration
of the impact of the COVID-19 pandemic on its financial results.
Inspire will continue to evaluate the impact of the COVID-19
pandemic on its business and plans to provide additional information, to the extent practicable, during its first quarter earnings
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.
Financial Disclosure Advisory
The Company reports its financial results in accordance with
U.S. generally accepted accounting principles. The expected financial results discussed in this press release are preliminary and
represent the most current information available to the Company's management, as financial closing procedures for the quarter
ended March 31, 2020 are not yet complete. These estimates are not a comprehensive statement of the Company's financial results
for the quarter ended March 31, 2020 and actual results may differ materially from these estimates as a result of the completion
of normal quarter-end accounting procedures and adjustments, including the execution of the Company's internal control over
financial reporting, the completion of the preparation and review of the Company's financial statements for the quarter ended
March 31, 2020 and the subsequent occurrence or identification of events prior to the formal issuance of the first quarter financial
Forward Looking Statements
contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All
statements other than statements of historical facts are forward-looking statements, including, without limitation,
statements regarding our belief that the shelter-in-place policies and restrictions on elective surgical procedures in the
U.S. and Europe will substantially impact our revenue and financial results, belief patients and hospitals in the U.S.
and Europe will be eager to schedule procedures once the threat of COVID-19 subsides,
expectation that a substantial portion of postponed Inspire therapy procedures will be rescheduled, the activity of
our commercial team once circumstances allow, the impact of our business from the
COVID-19 pandemic, financial results for the first quarter 2020, full year 2020 financial outlook, training new centers,
future positive insurance coverage of Inspire therapy and improvements in market access. In some cases, you can identify
forward-looking statements by terms such as may,'' will,''
should,'' expect,'' plan,''
anticipate,'' could,'' "future," "outlook,"
"guidance," intend,'' target,''
project,'' contemplate,'' believe,''
estimate,'' predict,'' potential,''
continue,'' or the negative of these terms or other similar expressions, although not all
forward-looking statements contain these words.
These forward-looking
statements are based on management's current expectations and involve known and unknown risks and uncertainties that may
cause our actual results, performance or achievements to be materially different from any future results, performance or achievements
expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, estimates regarding
the annual total addressable market for our Inspire therapy in the U.S. and our market opportunity outside the U.S.; future results
of operations, financial position, research and development costs, capital requirements and our needs for additional financing;
commercial success and market acceptance of our Inspire therapy; the impact of the ongoing and global COVID-19 pandemic; general
Last updated: Apr 13, 2020