Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies
for the sports medicine and severe burn care markets, today
announced preliminary financial results for the quarter ended
September 30, 2020.
Preliminary total net revenues for the third
quarter are expected to be approximately $32 million, including
approximately $24.2 million of MACI® (autologous cultured
chondrocytes on porcine collagen membrane) net revenue,
approximately $6.7 million of Epicel® (cultured epidermal
autografts) net revenue, and approximately $1.2 million of revenue
related to the procurement of NexoBrid® (concentrate of proteolytic
enzymes enriched in bromelain) by the U.S. Biomedical Advanced
Research and Development Authority (BARDA) for emergency response
preparedness.
The company generated approximately $4.6 million of
operating cash flow in the third quarter. As of September 30, 2020,
the company had approximately $85.5 million in cash and investments
and no debt, compared to $79.0 million as of December 31, 2019.
“We are very pleased with our third quarter results
as we generated consistent double-digit growth in revenue, implants
and biopsies for MACI and achieved a record monthly high for
biopsies in September,” said Nick Colangelo, President and CEO of
Vericel. “Moreover, the robustness of our business model was
demonstrated as we generated positive operating cash flow for the
quarter. While considerable uncertainties related to COVID-19
remain, given the strength of our patient pipeline, we expect to
maintain strong MACI growth in the fourth quarter. We look forward
to providing further updates to investors during our upcoming
virtual Analyst and Investor Day webcast and our third quarter
earnings call.”
As previously announced, the company will host a
virtual Analyst and Investor Day on October 16, 2020, at 9:00am
Eastern Time. The company also will host a webcast and conference
call to discuss its third quarter 2020 financial results and
business highlights on November 5, 2020, at 8:30am Eastern Time.
Webcast information can be found on the events and presentation
section of the Investor Relations website at
https://investors.vcel.com/events-presentations.
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. ©
2020 Vericel Corporation. All rights reserved.
Preliminary and Unaudited Nature of
Reported ResultsOur revenue expectations for the third
quarter, as well as our estimates concerning operating cash flow
and 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, 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 third quarter of 2020
and estimates of operating cash flow and our cash and investments
as of September 30, 2020. Vericel’s revenue expectations and
operating cash flow for the third quarter, as well as its estimates
concerning cash and investments are preliminary, unaudited and are
subject to adjustment during our ongoing internal review.
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 our
expectations regarding future revenues, growth in revenues, market
penetration for MACI and Epicel, growth in profit, gross margins
and operating margins, the ability to achieve or sustain
profitability, contributions to adjusted EBITDA, the expected
target surgeon audience, potential fluctuations in sales and
volumes and our results of operations over the course of the year,
competitive developments, changes in third party coverage and
reimbursement, our ability to supply or meet customer demand for
our products, and the wide-ranging impacts 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 pace with which state and local governments lift
restrictions on the performance of elective surgical procedures or
whether additional such restrictions may be imposed by states in
the future, the availability of physicians and/or their treatment
prioritizations or the impact of the outbreak on the overall
healthcare infrastructure. 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 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. With respect to FDA’s review of the pending NexoBrid
Biologics License Application, the COVID-19 pandemic may impact the
FDA’s response time to regulatory submissions, its ability to
monitor our clinical trials, and/or conduct necessary reviews or
inspections, any or all of which may result in timelines being
materially delayed, which could affect the development and ultimate
commercialization of NexoBrid. 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, Vericel’s
Quarterly Report on Form 10-Q for the quarter ended June 30, 2020,
filed with the SEC on August 5, 2020, and in other filings with the
SEC. These forward-looking statements reflect our 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.
Investor Contacts: Lee
SternSolebury Troutlstern@troutgroup.com+1 (646) 378-2922
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