STAAR Surgical Provides COVID-19 Business Update
April 13 2020 - 7:00AM
Business Wire
STAAR Surgical Company (NASDAQ: STAA), a leading developer,
manufacturer and marketer of implantable lenses and companion
delivery systems for the eye, today provided a business update
relating to the evolving COVID-19 global health care concern.
“We have made the decision to get out in front of our
traditional earnings call communications to let you know how STAAR
is faring during the COVID-19 pandemic. It is clear that the health
and safety of everyone around the globe is paramount and we are
practicing, by country served, the required directives from
national and local governments and public health officials,” said
Caren Mason, President and CEO. “The following are facts as they
exist today regarding STAAR’s business continuity:
- We have a highly specialized work force and will support them
effectively throughout the pandemic requirements in their
respective geographies. We continue to pay all of our employees’
salaries, commissions, wages and benefits during this time while
many of our employees effectively work remotely. We suspended most
of our production on March 17th with the exception of continuation
of critical late-staged processes. We anticipate resuming
production this month and achieving full production during Q2.
- We have shipped to our global packaging and distribution center
in Nidau, Switzerland inventory to support all of our expected
global requirements with the exception of the U.S. which is
serviced out of Monrovia, California. We have shipped to China
requested quantities of billable units and several pallets of
consignment inventory to support Q2 busy season requirements. We
did this out of an abundance of caution to be sure China would be
able to meet the demand they are forecasting. We also shipped
billable and consignment inventory to Korea which experienced a
significant increase in implants over prior year in March. Our
business in Japan remains strong and we have stocked our STAAR
owned distribution center there to meet demand.
- Through the third week in March, our Q1 sales posted solid
double-digit growth over prior year period. From March 20th through
April 3rd, we experienced a substantial slowdown in global
geographies characterized as “hot spots” for the COVID-19 virus
during that timeframe. We expect this slowdown to continue and, in
some markets, expect sales to pause as elective surgeries are
discouraged to support COVID-19 related needs. While the global
markets in “hot spots” recede or cease ordering, our teams report
recovery or continuation of recent strong trends in much of Asia
which currently represents over 60% of our business. Our teams in
“hot spot” areas are following our successful playbook for engaging
in extensive remote customer outreach programs that includes
digital training courses during the business slowdown in their
markets.
- Our CRO (Contract Research Organization) has worked
individually with each of our implanting sites in the U.S. for the
EVO clinical trial. The sites, with the CRO, determined effective
plans to continue caring for patients in the trial and determined
if or when to suspend implanting EVO lenses in new patients. We
will not address impact on the timing of the study at this time.
Each of our sites has patients in the queue and we expect to
ramp-up as soon as it is acceptable to resume the study with each
site determining with the CRO what that timing may be.
- Our balance sheet is strong with $120 million of cash at
January 3, 2020 that we anticipate can support operations if
required for the foreseeable future. We continue to receive
payments from our largest customers while we expect our AR to grow
over these next few months with smaller clinics the most
financially impacted by the pandemic.”
Preliminary First Quarter Net Sales. STAAR expects total
net sales for the first quarter ended April 3, 2020 to be
approximately $34.9 million, up approximately 7% as compared to the
prior year period. The Company estimates COVID-19 negatively
impacted first quarter sales by approximately $4 million, less than
previously estimated. Despite the pandemic’s impact on business,
first quarter ICL unit growth is expected to be up approximately 9%
with strong performance in Japan, Korea, Canada, Germany and the
rest of Asia Pacific countries not including China. China’s growth
was up 7% due to a strong January and ordering resuming in the
final two weeks of the quarter. Implant rates in China were up
significantly in the past two weeks.
Fiscal 2020 Outlook. While the Company remains confident
about its prospects, due to the shifting nature of COVID-19, the
Company is withdrawing its outlook for fiscal 2020. Any future
updates to the Company’s outlook will be based on the timing and
duration to a resolution of the COVID-19 global health care
concern.
STAAR expects to report complete first quarter financial results
on or about May 6 and provided today’s information to timely
address inquiries relating to the evolving COVID-19 pandemic. The
financial information in this release is unaudited and subject to
adjustment in the final audited financial statements to be filed
with the Company’s Quarterly Report on Form 10-Q.
About STAAR Surgical
STAAR, which has been dedicated solely to ophthalmic surgery for
over 30 years, designs, develops, manufactures and markets
implantable lenses for the eye with companion delivery systems.
These lenses are intended to provide visual freedom for patients,
lessening or eliminating the reliance on glasses or contact lenses.
All of these lenses are foldable, which permits the surgeon to
insert them through a small incision. STAAR’s lens used in
refractive surgery is called an Implantable Collamer® Lens or
“ICL”, which includes the EVO Visian ICL™ product line. More than
1,000,000 Visian® ICLs have been implanted to date and STAAR
markets these lenses in over 75 countries. To learn more about the
ICL go to: www.discovericl.com. Headquartered in Lake Forest, CA,
the company operates manufacturing and packaging facilities in
Aliso Viejo, CA, Monrovia, CA and Nidau, Switzerland. For more
information, please visit the Company’s website at
www.staar.com.
Safe Harbor
All statements in this press release that are not statements of
historical fact are forward-looking statements, including
statements about any of the following: any financial projections,
including those relating to the plans, strategies, and objectives
of management for 2020 or prospects for achieving such plans,
expectations for sales, revenue, or earnings, the impact of the
COVID-19 pandemic (including but not limited to its impact on
sales, operations or clinical trials globally), product safety or
effectiveness, the status of our pipeline of ICL products with
regulators, including our EDOF lens for Presbyopia and our EVO
family of lenses in the U.S., and any statements of assumptions
underlying any of the foregoing, including those relating to our
product pipeline and market expansion activities. Important factors
that could cause actual results to differ materially from those
indicated by such forward-looking statements are set forth in the
Company’s Annual Report on Form 10-K for the year ended January 3,
2020 under the caption “Risk Factors,” which is on file with the
Securities and Exchange Commission and available in the “Investor
Information” section of the company’s website under the heading
“SEC Filings.” We disclaim any intention or obligation to update or
revise any financial projections or forward-looking statement due
to new information or events. These statements are based on
expectations and assumptions as of the date of this press release
and are subject to numerous risks and uncertainties, which could
cause actual results to differ materially from those described in
the forward-looking statements. The risks and uncertainties include
the following: global economic conditions; the discretion of
regulatory agencies to approve or reject existing, new or improved
products, or to require additional actions before approval, or to
take enforcement action; international trade disputes; and the
willingness of surgeons and patients to adopt a new or improved
product and procedure. The Visian ICL with Contraflow’s, now known
as EVO Visian ICL, is not yet approved for sale in the United
States.
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version on businesswire.com: https://www.businesswire.com/news/home/20200413005098/en/
Investors & Media Brian Moore Vice President,
Investor, Media Relations and Corporate Development (626) 303-7902,
Ext. 3023 bmoore@staar.com
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