Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies
for the sports medicine and severe burn care markets, today
reported financial results and business highlights for the first
quarter ended March 31, 2022.
First Quarter 2022 Financial Highlights
- Total net revenue of $36.1 million,
compared to $34.6 million in the first quarter of 2021
- MACI® net revenue of $26.0 million,
Epicel® net revenue of $9.9 million, and NexoBrid® revenue of $0.2
million related to the U.S. Biomedical Advanced Research and
Development Authority (“BARDA”) procurement for emergency response
preparedness
- Gross margin of 65%, compared to 66%
in the first quarter of 2021
- Net loss of $7.1 million, or $0.15
per share, compared to $3.3 million, or $0.07 per share, in the
first quarter of 2021
- Non-GAAP adjusted
EBITDA of $3.2 million, compared to $4.6 million in the first
quarter of 2021
- Operating cash
flow of $3.5 million
- As of March 31,
2022, the Company had approximately $130 million in cash,
restricted cash and investments, and no debt
Business Highlights and Updates
- Double-digit growth in surgeons taking MACI biopsies compared
to the first quarter of 2021, with the second highest monthly
biopsies in March 2022 since the launch of MACI
- Growth of more than 20% in burn centers treating patients and
taking Epicel biopsies compared to the first quarter of 2021, with
a record monthly high in Epicel biopsies in March 2022
- Remain on track for a planned mid-year 2022 resubmission of the
NexoBrid Biologics License Application to the FDA, and
- Expanded the Company’s commercial leadership team with the
appointment of Mike Gilligan as Vice President, MACI National
Sales
“The Company executed well in the first quarter and we remain on
track to deliver another year of significant revenue growth, margin
expansion, and operating cash flow driven by continued strong
results for both MACI and Epicel,” said Nick Colangelo, President
and CEO of Vericel. “We also continue to advance important
regulatory and clinical programs across both our sports medicine
and burn care franchises as we remain on track for a mid-year
resubmission of the NexoBrid BLA and for planned discussions with
the FDA to review both the MACI arthroscopic and ankle development
programs, initiatives that we believe will support continued strong
growth in the years ahead.”
2022 Financial GuidanceThe Company reaffirmed
financial guidance for full-year 2022
- Total net revenue for 2022 expected
to be in the range of $178 to $189 million
- MACI revenue expected to be in the
range of $132 to $141 million
- Epicel revenue expected to be in the
range of $45.5 to $47.5 million
- Gross margin expected to be
approximately 70%
- Adjusted EBITDA margin expected to
be approximately 21%
First Quarter 2022 ResultsTotal net revenue for
the quarter ended March 31, 2022 increased 4% to $36.1 million,
compared to $34.6 million in the first quarter of 2021. Total net
product revenue for the quarter increased 7% and included $26.0
million of MACI (autologous cultured chondrocytes on porcine
collagen membrane) net revenue and $9.9 million of Epicel (cultured
epidermal autografts) net revenue, compared to $23.8 million of
MACI net revenue and $9.8 million of Epicel net revenue,
respectively, in the first quarter of 2021. Total net revenue for
the quarter also included $0.2 million of revenue related to the
procurement of NexoBrid (concentrate of proteolytic enzymes
enriched in bromelain) by BARDA for emergency response
preparedness, compared to $0.9 million in the first quarter of
2021.
Gross profit for the quarter ended March 31, 2022 was $23.5
million, or 65% of net revenue, compared to $23.0 million, or 66%
of net revenue, for the first quarter of 2021.
Total operating expenses for the quarter ended March 31, 2022
were $30.7 million, compared to $26.3 million for the same period
in 2021. The increase in operating expenses was primarily due to
higher stock-based compensation expense.
Net loss for the quarter ended March 31, 2022 was $7.1 million,
or $0.15 per share, compared to a net loss of $3.3 million, or
$0.07 per share, for the first quarter of 2021.
Non-GAAP adjusted EBITDA for the quarter ended March 31, 2022
was $3.2 million, or 9% of net revenue, compared to $4.6 million,
or 13% of net revenue, for the first quarter of 2021. A table
reconciling non-GAAP measures is included in this press release for
reference.
As of March 31, 2022, the Company had approximately $130 million
in cash, restricted cash and investments, and no debt.
Conference Call Information Today’s conference
call will be available live at 8:30am Eastern Time and can be
accessed through the Investor Relations section of the Vericel
website at http://investors.vcel.com/events-presentations. A slide
presentation with highlights from today’s conference call will be
available on the webcast and in the Investor Relations section of
the Vericel website. Please access the site at least 15 minutes
prior to the scheduled start time in order to download the required
audio software, if necessary. To participate in the live call by
telephone, please call (877) 312-5881 and reference Vericel
Corporation’s first quarter 2022 investor conference call. If
calling from outside the U.S., please use the international phone
number (253) 237-1173.
If you are unable to participate in the live call, the webcast
will be available at http://investors.vcel.com/events-presentations
until May 4, 2023. The conference ID is 7195435.
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 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.
GAAP v. Non-GAAP MeasuresVericel’s reported
earnings are prepared in accordance with generally accepted
accounting principles in the United States, or GAAP, and represent
earnings as reported to the Securities and Exchange Commission.
Vericel has provided in this release certain financial
information that has not been prepared in accordance with
GAAP. Vericel’s management believes that the non-GAAP
adjusted EBITDA described in the release, which includes
adjustments for specific items that are generally not indicative of
our core operations, provides additional information that is useful
to investors in understanding Vericel’s underlying performance,
business and performance trends, and helps facilitate
period-to-period comparisons and comparisons of its financial
measures with other companies in Vericel’s industry. However,
the non-GAAP financial measures that Vericel uses may differ from
measures that other companies may use. Non-GAAP financial
measures are not required to be uniformly applied, are not audited
and should not be considered in isolation or as substitutes for
results prepared in accordance with GAAP.
Epicel® and MACI® are registered trademarks of Vericel
Corporation. NexoBrid® is a registered trademark of MediWound Ltd.
(MediWound) and is used under license to Vericel Corporation. ©
2022 Vericel Corporation. All rights reserved.
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 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 revenue, growth in revenue, 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,
timing and conduct of clinical trial and product development
activities, timing of the resubmission to the Food & Drug
Administration (FDA) of a Biologics License Application (BLA) for
NexoBrid seeking approval for the treatment of severe burns in the
United States following MediWound’s receipt of a complete response
letter on June 28, 2021, timing or likelihood of approval by the
FDA of the NexoBrid BLA resubmission, the estimate of the
commercial growth potential of our products and product candidates,
availability of funding from BARDA under its agreement with
MediWound for use in connection with NexoBrid development
activities, competitive developments, changes in third-party
coverage and reimbursement, our ability to supply or meet customer
demand for our products, and the ongoing impacts of the COVID-19
pandemic on our business or the economy generally.
With respect to COVID-19, we are currently unable to predict
whether a future resurgence of COVID-19 infections will result in
future restrictions on the performance of elective surgical
procedures or affect the availability of physicians and/or their
treatment prioritizations, cause healthcare facility staffing
shortages, effect the willingness or ability of patients to seek
treatment, or heighten the impact of the pandemic 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 or other incremental
mitigation efforts or initiatives 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 NexoBrid, the COVID-19 pandemic may impact the FDA’s response
times to future regulatory submissions, its ability to monitor our
clinical trials, and/or conduct necessary reviews or inspections of
manufacturing facilities involved in the production of NexoBrid,
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, 2021, filed with the Securities and Exchange
Commission (SEC) on February 24, 2022, Vericel’s Quarterly Report
on Form 10-Q for the quarter ended March 31, 2022, filed with the
SEC on May 4, 2022, 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 Contact: Eric Burnsir@vcel.com +1
(734) 418-4411
Media Contact:Julie
Downsjdowns@vcel.com
VERICEL
CORPORATIONCONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(Unaudited, amounts in thousands, except
per share amounts)
|
|
Three Months Ended March 31, |
|
|
|
2022 |
|
|
|
2021 |
|
Product sales, net |
|
$ |
35,852 |
|
|
$ |
33,627 |
|
Other revenue |
|
|
222 |
|
|
|
941 |
|
Total revenue |
|
|
36,074 |
|
|
|
34,568 |
|
Cost of product sales |
|
|
12,622 |
|
|
|
11,583 |
|
Gross profit |
|
|
23,452 |
|
|
|
22,985 |
|
Research and development |
|
|
4,860 |
|
|
|
3,630 |
|
Selling, general and administrative |
|
|
25,865 |
|
|
|
22,660 |
|
Total operating expenses |
|
|
30,725 |
|
|
|
26,290 |
|
Loss from operations |
|
|
(7,273 |
) |
|
|
(3,305 |
) |
Other income (expense): |
|
|
|
|
Interest income |
|
|
88 |
|
|
|
76 |
|
Interest expense |
|
|
(18 |
) |
|
|
(1 |
) |
Other income |
|
|
112 |
|
|
|
84 |
|
Total other income |
|
|
182 |
|
|
|
159 |
|
Loss before income taxes |
|
|
(7,091 |
) |
|
|
(3,146 |
) |
Income tax expense |
|
|
— |
|
|
|
143 |
|
Net loss |
|
$ |
(7,091 |
) |
|
$ |
(3,289 |
) |
Net loss per common
share: |
|
|
|
|
Basic |
|
$ |
(0.15 |
) |
|
$ |
(0.07 |
) |
Diluted |
|
$ |
(0.15 |
) |
|
$ |
(0.07 |
) |
Weighted-average common shares
outstanding: |
|
|
|
|
Basic |
|
|
46,985 |
|
|
|
45,984 |
|
Diluted |
|
|
46,985 |
|
|
|
45,984 |
|
VERICEL CORPORATION
RECONCILIATION OF REPORTED NET LOSS
(GAAP) TO ADJUSTED EBITDA (NON-GAAP
MEASURE)(Unaudited, amounts in
thousands)
|
|
Three Months Ended March 31, |
|
|
|
2022 |
|
|
|
2021 |
|
Net loss |
|
$ |
(7,091 |
) |
|
$ |
(3,289 |
) |
Stock-based compensation expense |
|
|
9,531 |
|
|
|
7,019 |
|
Depreciation and amortization |
|
|
873 |
|
|
|
811 |
|
Net interest income |
|
|
(70 |
) |
|
|
(75 |
) |
Income tax expense |
|
|
— |
|
|
|
143 |
|
Adjusted EBITDA
(Non-GAAP) |
|
$ |
3,243 |
|
|
$ |
4,609 |
|
VERICEL
CORPORATIONCONDENSED CONSOLIDATED BALANCE
SHEETS(Unaudited, amounts in
thousands)
|
|
March 31, |
|
December 31, |
|
|
2022 |
|
2021 |
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
55,659 |
|
$ |
68,330 |
Short-term investments |
|
|
44,888 |
|
|
35,068 |
Accounts receivable (net of allowance for doubtful accounts of $40
and $40, respectively) |
|
|
31,855 |
|
|
37,437 |
Inventory |
|
|
14,385 |
|
|
13,381 |
Other current assets |
|
|
5,093 |
|
|
4,246 |
Total current assets |
|
|
151,880 |
|
|
158,462 |
Property and equipment, net |
|
|
14,451 |
|
|
13,308 |
Restricted cash |
|
|
6,184 |
|
|
211 |
Right-of-use assets |
|
|
44,653 |
|
|
45,720 |
Long-term investments |
|
|
22,803 |
|
|
25,687 |
Other long-term assets |
|
|
317 |
|
|
317 |
Total assets |
|
$ |
240,288 |
|
$ |
243,705 |
LIABILITIES AND
SHAREHOLDERS’ EQUITY |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
7,750 |
|
$ |
9,016 |
Accrued expenses |
|
|
10,793 |
|
|
14,045 |
Current portion of operating lease liabilities |
|
|
3,147 |
|
|
2,950 |
Other current liabilities |
|
|
41 |
|
|
41 |
Total current liabilities |
|
|
21,731 |
|
|
26,052 |
Operating lease liabilities |
|
|
46,053 |
|
|
47,147 |
Other long-term liabilities |
|
|
19 |
|
|
44 |
Total liabilities |
|
$ |
67,803 |
|
$ |
73,243 |
Total shareholders’ equity |
|
|
172,485 |
|
|
170,462 |
Total liabilities and shareholders’ equity |
|
$ |
240,288 |
|
$ |
243,705 |
Vericel (NASDAQ:VCEL)
Historical Stock Chart
From Mar 2024 to Apr 2024
Vericel (NASDAQ:VCEL)
Historical Stock Chart
From Apr 2023 to Apr 2024