Item 7.01. Regulation FD Disclosure.
Cardiovascular Systems, Inc. (the "Company") is providing an update regarding
the impact of COVID-19 on its business in the three months ending September 30,
2021. The volume of procedures involving the Company's products has been
adversely impacted by hospital capacity constraints due to increased
hospitalizations caused by the COVID-19 Delta variant, particularly in Florida,
Texas and other areas significantly impacted by COVID-19. In addition to
constraints in hospital capacity, the Company has observed disruption of
referral patterns, deferral of elective procedures, staffing shortages and
heightened summer seasonality. The impact of these factors is more pronounced
because procedure volumes involving the Company's products tend to be heavily
weighted in September, relative to July and August. The Company believes that
these factors will result in lower than anticipated revenue in the first quarter
of fiscal 2022, with the potential adverse impact on anticipated revenue for the
full quarter to be greater than 10% of our prior expectations. The Company
believes that the effects of the Delta variant, or future variants, as well as
these other factors, create additional uncertainty with respect to the Company's
revenue performance throughout the current fiscal year.
The Company's financial guidance for the full fiscal year ending June 30, 2022,
issued on August 4, 2021, did not contemplate an impact from COVID-19, given
that the waves of COVID-19 cases experienced in fiscal 2021 caused transient
sales declines which were followed by a recovery and more normalized sales
trends over the full 12-month period. The Company anticipated that it would
experience a similar trend in fiscal 2022; however, in the first quarter, the
negative impact due to the Delta variant was larger than anticipated and may, or
may not, normalize over the course of the full fiscal year. Accordingly, the
Company is not at this time withdrawing or updating its guidance and will
continue to monitor and assess the situation. The Company will provide an update
with its earnings release for the first quarter.
Forward-Looking Statements
Statements in this Form 8-K regarding the potential future impact of COVID-19 on
the Company's business and financial results are forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of 1995 and
are provided under the protection of the safe harbor for forward-looking
statements provided by that Act. These statements involve risks and
uncertainties that could cause results to differ materially from those
projected, including, but not limited to, the pendency and impact of COVID-19,
government actions, material delays and cancellations of procedures, delayed
spending by healthcare providers, supply chain disruptions, and other factors
detailed from time to time in the Company's SEC reports, including its most
recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q.
The Company encourages you to consider all of these risks, uncertainties and
other factors carefully in evaluating the forward-looking statements contained
in this Form 8-K. As a result of these matters, changes in facts, assumptions
not being realized or other circumstances, the Company's actual results may
differ materially from the expected results discussed in the forward-looking
statements contained in this Form 8-K. The forward-looking statements made in
this Form 8-K are made only as of the date of this Form 8-K, and the Company
undertakes no obligation to update them to reflect subsequent events or
circumstances.
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