Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies
for the sports medicine and severe burn care markets, today
announced preliminary unaudited product revenue growth for the
quarter ended March 31, 2020, and provided business and financial
updates related to the COVID-19 pandemic.Over the past several
weeks, Vericel has implemented several measures to safeguard the
health and well-being of its employees, their families, and
healthcare providers, while continuing to supply its autologous
cell therapy products MACI® (autologous cultured chondrocytes on
porcine collagen membrane) and Epicel® (cultured epidermal
autografts) to patients with knee cartilage and severe burn
injuries. At this time, all Vericel employees not directly
involved in the production and delivery of MACI or Epicel are
working from home. For production-related teams, the Company
has implemented additional measures to protect the health and
safety of its workforce. Vericel representatives will also
continue to provide field-based support for surgical cases, as
needed, in compliance with applicable government mandated business
activity restrictions and facility access rules.
“First and foremost, our thoughts are with those affected by the
virus and we are especially thankful to all healthcare workers for
their critical efforts to support patients during this challenging
time,” said Nick Colangelo, President and Chief Executive Officer
of Vericel. “While our MACI business has been impacted by the
restrictions on elective surgical procedures, the fundamentals of
our business remain strong. Prior to cancellations that
occurred in the last two weeks of the quarter, MACI was on track to
exceed revenue growth guidance and we believe that most patients
will reschedule cases to the extent possible following this crisis.
In addition, we believe that Epicel may be less directly
impacted by the pandemic given the critical nature of severe burn
injuries. We are implementing a number of initiatives to
maintain our near-term and future growth opportunities while
supporting patients and reducing non-essential discretionary
spending. Given the strength of our financial position and
the underlying fundamentals of our business, we believe that the
Company is well-positioned to maintain its leadership position in
the sports medicine and severe burn care markets.”
Preliminary Unaudited First Quarter Results and 2020
Financial GuidancePreliminary unaudited total revenues for
the quarter ended March 31, 2020 increased approximately 21%
compared to the first quarter of 2019, with MACI revenue increasing
approximately 21% and Epicel revenue increasing approximately 22%.
As a result of various national, state and local restrictions
on elective surgical procedures related to the COVID-19 pandemic,
beginning in the middle of March there was a significant increase
in cancellations of scheduled MACI procedures as well as a slowdown
in new MACI orders. The number of MACI procedures scheduled
to occur in the first quarter that were cancelled between March 15,
2020 and the end of the quarter reduced the volume of MACI implants
for the quarter by approximately 9%.
Due to the significant uncertainty regarding the duration and
impact of restrictions on elective procedures related to the
COVID-19 pandemic, and the fact that the U.S. Biomedical Advanced
Research and Development Authority (BARDA) may adjust the emergency
stockpile delivery plan for NexoBrid® due to shifting priorities
related to the pandemic, the Company is withdrawing its previously
announced 2020 financial guidance, which was issued on February 25,
2020. At this time, the Company cannot predict the extent or
duration of the impact of the COVID-19 outbreak on its financial
and operating results. The Company plans to provide
additional information, to the extent practicable, during its first
quarter earnings call in May.
Financial Position and Business Continuity The
Company started the year in a strong position across multiple
dimensions and is taking prudent measures to ensure a rapid return
to normal operations when conditions allow. As of March 31,
2020, the Company had approximately $83 million in cash and
investments and carries no debt. Moreover, appropriate
expense reduction measures have been implemented.
The Company continues to manufacture MACI and Epicel and
maintains a significant safety stock of all key raw
materials. At this time there is no indication that supply
chain interruptions will impact the Company’s ongoing manufacturing
operations. The Company also continues to plan for a mid-2020
submission of the NexoBrid Biologics License Application to the
FDA. To drive current and future demand, the Company’s 71
MACI and 10 Epicel sales representatives and clinical support
specialists are adapting their practices to support physician
education initiatives using virtual tools in regions where
executive orders or hospital restrictions preclude their physical
presence.
About
Vericel CorporationVericel is a leader in advanced
therapies for the sports medicine and severe burn care
markets. The company markets two cell therapy products in the
United States. MACI® (autologous cultured chondrocytes on
porcine collagen membrane) is an autologous cellularized scaffold
product indicated for the repair of symptomatic, single or multiple
full-thickness cartilage defects of the knee with or without bone
involvement in adults. Epicel® (cultured epidermal
autografts) is a permanent skin replacement for the treatment of
patients with deep dermal or full-thickness burns greater than or
equal to 30% of total body surface area. The company also
holds an exclusive license for North American commercial rights to
NexoBrid®, a registration-stage biological orphan product for
debridement of severe thermal burns. For more information,
please visit the company’s website at www.vcel.com.
Epicel® and MACI® are registered trademarks of Vericel
Corporation. NexoBrid® is a registered trademark of MediWound Ltd.
and is used under license to Vericel Corporation. © 2019 Vericel
Corporation. All rights reserved.
Preliminary and Unaudited Nature of Reported
ResultsOur revenue expectations for the first quarter, as
well as our estimates concerning cash and investments are
preliminary, unaudited and are subject to adjustment in the course
of our ongoing internal control and review procedures.
Forward-Looking StatementsVericel cautions you
that all statements other than statements of historical fact
included in this press release that address activities, events or
developments that we expect, believe or anticipate will or may
occur in the future are forward-looking statements. Although
we believe that we have a reasonable basis for the forward-looking
statements contained herein, we caution you that they are based on
current expectations about future events affecting us and are
subject to risks, assumptions, uncertainties and factors relating
to our operations and business environment, all of which are
difficult to predict and many of which are beyond our
control. Our actual results may differ materially from those
expressed or implied by the forward-looking statements in this
press release. These statements are often, but are not
always, made through the use of words or phrases such as
“anticipates,” “intends,” “estimates,” “plans,” “expects,”
“continues,” “believe,” “guidance,” “outlook,” “target,” “future,”
“potential,” “goals” and similar words or phrases, or future or
conditional verbs such as “will,” “would,” “should,” “could,”
“may,” or similar expressions.
Among the factors that may result in differences are the
inherent uncertainties associated with our expectations concerning
expected revenue results for the first quarter of 2020 and
estimates of our cash and investments as of March 31, 2020.
Vericel’s revenue expectations for the first quarter, as well as
its estimates concerning cash and investments are preliminary,
unaudited and are subject to adjustment in the course of our
ongoing internal review. Our internal control procedures over
financial reporting have not yet been completed and therefore, the
growth in revenue and cash and investments as described herein have
not been evaluated under our internal control framework.
Additional factors that could cause actual results to differ
materially from those set forth in the forward-looking statements
include, but are not limited to uncertainties associated with
growth in revenues for MACI and Epicel, the expected target surgeon
audience, the estimate of the commercial growth potential of our
products and product candidates, availability of funding from the
Biomedical Research and Development Authority (“BARDA”) under its
agreement with MediWound Ltd. for use in connection with NexoBrid
development activities, potential fluctuations in sales and volumes
and our results of operations over the course of the year,
competitive developments, timing and conduct of clinical trial and
product development activities, timing or likelihood of regulatory
submissions or approvals, market demand for our products, changes
in third party coverage and reimbursement, our ability to maintain
and expand our network of direct sales employees, our ability to
supply or meet customer demand for our products, and the impact of
the COVID-19 pandemic on our business or the economy generally.
With respect to COVID-19, we are currently unable to reasonably
estimate the specific extent, or duration, of the impact of the
COVID-19 outbreak on our business, financial and operating
results. We are also unable to predict how the outbreak will
affect the availability of physicians and/or their treatment
prioritizations or the impact of the outbreak on the overall
healthcare infrastructure. In addition to impacts on
procedure and surgery volumes, we are experiencing and may
experience other disruptions as a result of the COVID-19
outbreak. For example, enrollment in our clinical trials may
be adversely affected. In addition, patients who have
cancelled or postponed surgeries may not reschedule cases in a
timely fashion, or at all. Other disruptions or potential
disruptions include restrictions on the ability of Company
personnel to travel and access customers for training, promotion
and case support, delays in approvals by regulatory bodies, delays
in product development efforts, and additional government-imposed
quarantines and requirements to “shelter at home” or other
incremental mitigation efforts that may impact our ability to
source supplies for our operations or our ability or capacity to
manufacture, sell and support the use of our products. The
total impact of these disruptions could have a material impact on
the Company’s financial condition, cash flows and results of
operations.
These and other significant factors are discussed in greater
detail in Vericel’s Annual Report on Form 10-K for the year ended
December 31, 2019, filed with the Securities and Exchange
Commission (“SEC”) on February 25, 2020, and in other filings with
the SEC, including the Report on Form 8-K filed by the Company on
April 2, 2020. These forward-looking statements reflect
management’s views as of the date hereof and Vericel does not
assume and specifically disclaims any obligation to update any of
these forward-looking statements to reflect a change in its views
or events or circumstances that occur after the date of this
release except as required by law.
Global Media Contacts:David SchullRusso
Partners LLCDavid.schull@russopartnersllc.com+1 212-845-4271
(office)+1 858-717-2310 (mobile)
Investor Contacts:Lee SternSolebury
Troutlstern@troutgroup.com+1 (646) 378-2922
Vericel (NASDAQ:VCEL)
Historical Stock Chart
From Aug 2024 to Sep 2024
Vericel (NASDAQ:VCEL)
Historical Stock Chart
From Sep 2023 to Sep 2024