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, 2024.
First Quarter 2024 Financial Highlights
- Total net revenue increased 25% to
$51.3 million
- MACI® net revenue growth of 18% to
$40.2 million
- Burn Care net revenue growth of 63%
to $11.1 million, consisting of $10.7 million of Epicel® revenue
and $0.4 million of NexoBrid® revenue
- Gross margin of 69%
- Net loss of $3.9 million, or $0.08
per diluted share
- Non-GAAP adjusted
EBITDA increased 325% to $7.2 million, representing adjusted EBITDA
margin of 14%
- Operating cash
flow of $7.2 million
- As of March 31, 2024, the Company
had approximately $148 million in cash, restricted cash and
investments, and no debt
Business Highlights and Updates
- Record first quarter total revenue and MACI revenue, and second
highest Epicel quarterly revenue since launch
- Record first quarter gross margin increased more than 400 basis
points and adjusted EBITDA margin expanded approximately 1,000
basis points versus prior year
- Second highest number of MACI biopsies and surgeons taking
biopsies in a quarter since launch
- NexoBrid launch progressing with more than 60 Pharmacy and
Therapeutics (P&T) committee submissions, approximately 40 burn
centers obtaining approval and more than 30 centers placing initial
orders
“The Company had a very strong start to the year, delivering
top-tier revenue growth with significant margin expansion and
profitability growth,” said Nick Colangelo, President and CEO of
Vericel. “Based on the strength of our core portfolio and the
contributions from new product launches, we believe that the
Company is very well-positioned for continued high revenue and
profit growth in 2024 and beyond.”
2024 Financial Guidance
- Total net revenue for 2024 now
expected to be in the range of $238 to $242 million, compared to
the previous guidance of $237 to $241 million
- Maintaining profitability guidance
of gross margin of approximately 70% and adjusted EBITDA margin of
approximately 20%
First Quarter 2024 ResultsTotal net revenue for
the quarter ended March 31, 2024 increased 25% to $51.3 million,
compared to $41.0 million in the first quarter of 2023. Total net
product revenue for the quarter included $40.2 million of MACI
(autologous cultured chondrocytes on porcine collagen membrane) net
revenue, $10.7 million of Epicel (cultured epidermal autografts)
net revenue, and $0.4 million of NexoBrid (anacaulase-bcdb) net
revenue, compared to $34.2 million of MACI net revenue and $6.8
million of Epicel net revenue, respectively, in the first quarter
of 2023.
Gross profit for the quarter ended March 31, 2024 was $35.4
million, or 69% of net revenue, compared to $26.5 million, or 65%
of net revenue, for the first quarter of 2023.
Total operating expenses for the quarter ended March 31, 2024
were $40.8 million, compared to $34.7 million for the same period
in 2023. The increase in operating expenses was primarily due to
development activities for MACI arthroscopic instruments, increased
headcount and related employee expenses and lease expense
associated with the Company’s new facility that is under
construction.
Net loss for the quarter ended March 31, 2024 was $3.9 million,
or $0.08 per diluted share, compared to $7.5 million, or $0.16 per
diluted share, for the first quarter of 2023.
Non-GAAP adjusted EBITDA for the quarter ended March 31, 2024
was $7.2 million, or 14% of net revenue, compared to $1.7 million,
or 4% of net revenue, for the first quarter of 2023. A table
reconciling non-GAAP measures is included in this press release for
reference.
As of March 31, 2024, the Company had approximately $148 million
in cash, restricted cash and investments, and no debt.
Conference Call Information Today’s conference
call will be available live at 8:30 a.m. 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 by telephone,
please register here to receive dial-in details and your personal
passcode. A replay of the webcast will be available on the Vericel
website until May 8, 2025.
About Vericel Corporation
Vericel is a leading provider of advanced therapies for the
sports medicine and severe burn care markets. The Company combines
innovations in biology with medical technologies, resulting in a
highly differentiated portfolio of innovative cell therapies and
specialty biologics that repair injuries and restore lives. Vericel
markets three 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. Vericel
also holds an exclusive license for North American rights to
NexoBrid (anacaulase-bcdb), a biological orphan product containing
proteolytic enzymes, which is indicated for the removal of eschar
in adults with deep partial-thickness and/or full-thickness burns.
For more information, please visit 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
this 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. and is used under license to Vericel Corporation. © 2024
Vericel Corporation. All rights reserved.
Forward-Looking Statements
Vericel 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, Epicel, and NexoBrid, growth in profit, gross
margins and operating margins, the ability to continue to scale our
manufacturing operations to meet the demand for our cell therapy
products, including the timely completion of a new headquarters and
manufacturing facility in Burlington, Massachusetts, 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 and likelihood of the FDA’s
potential approval of the arthroscopic delivery of MACI to the knee
or the use of MACI to treat cartilage defects in the ankle, the
estimate of the commercial growth potential of our products and
product candidates, competitive developments, changes in
third-party coverage and reimbursement, physician and burn center
adoption of NexoBrid, supply chain disruptions or other events or
factors affecting MediWound’s ability to manufacture and supply
sufficient quantities of NexoBrid to meet customer demand,
including but not limited to the ongoing Israel-Hamas war, negative
impacts on the global economy and capital markets resulting from
the conflict in Ukraine and the Israel-Hamas war, adverse
developments affecting financial institutions, companies in the
financial services industry or the financial services industry
generally, global geopolitical tensions or record inflation and
potential future impacts on our business or the economy generally
stemming from a resurgence of COVID-19 or another similar public
health emergency.
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, 2023, filed with the Securities and Exchange
Commission (SEC) on February 29, 2024, Vericel’s Quarterly Report
on Form 10-Q for the quarter ended March 31, 2024, filed with the
SEC on May 8, 2024, 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 Downsmedia@vcel.com
VERICEL CORPORATIONCONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS(in thousands, except per
share amounts - unaudited) |
|
|
Three Months Ended March 31, |
|
|
2024 |
|
|
|
2023 |
|
Product sales, net |
$ |
51,281 |
|
|
$ |
41,017 |
|
Total revenue |
|
51,281 |
|
|
|
41,017 |
|
Cost of product sales |
|
15,927 |
|
|
|
14,497 |
|
Gross profit |
|
35,354 |
|
|
|
26,520 |
|
Research and development |
|
6,418 |
|
|
|
5,212 |
|
Selling, general and administrative |
|
34,400 |
|
|
|
29,485 |
|
Total operating expenses |
|
40,818 |
|
|
|
34,697 |
|
Loss from operations |
|
(5,464 |
) |
|
|
(8,177 |
) |
Other income (expense): |
|
|
|
Interest income |
|
1,762 |
|
|
|
839 |
|
Interest expense |
|
(153 |
) |
|
|
(145 |
) |
Other expense |
|
(7 |
) |
|
|
(12 |
) |
Total other income |
|
1,602 |
|
|
|
682 |
|
Net loss |
$ |
(3,862 |
) |
|
$ |
(7,495 |
) |
Net loss per common
share: |
|
|
|
Basic and diluted |
$ |
(0.08 |
) |
|
$ |
(0.16 |
) |
Weighted-average common shares
outstanding: |
|
|
|
Basic and diluted |
|
48,141 |
|
|
|
47,387 |
|
VERICEL CORPORATIONRECONCILIATION OF
REPORTED NET LOSS (GAAP)TO ADJUSTED EBITDA
(NON-GAAP MEASURE)(in thousands -
unaudited) |
|
|
Three Months Ended March 31, |
|
|
2024 |
|
|
|
2023 |
|
Net loss |
$ |
(3,862 |
) |
|
$ |
(7,495 |
) |
Stock-based compensation expense |
|
9,834 |
|
|
|
8,731 |
|
Depreciation and amortization |
|
1,378 |
|
|
|
1,158 |
|
Net interest income |
|
(1,609 |
) |
|
|
(694 |
) |
Pre-occupancy lease expense |
|
1,477 |
|
|
|
— |
|
Adjusted EBITDA
(Non-GAAP) |
$ |
7,218 |
|
|
$ |
1,700 |
|
VERICEL CORPORATIONCONDENSED CONSOLIDATED
BALANCE SHEETS(in thousands -
unaudited) |
|
|
March 31, |
|
December 31, |
|
|
2024 |
|
|
|
2023 |
|
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
62,938 |
|
|
$ |
69,088 |
|
Restricted cash |
|
7,804 |
|
|
|
17,778 |
|
Short-term investments |
|
47,710 |
|
|
|
40,469 |
|
Accounts receivable (net of allowance for doubtful accounts of $87
and $43, respectively) |
|
49,934 |
|
|
|
58,356 |
|
Inventory |
|
13,557 |
|
|
|
13,087 |
|
Other current assets |
|
7,775 |
|
|
|
6,853 |
|
Total current assets |
|
189,718 |
|
|
|
205,631 |
|
Property and equipment, net |
|
56,392 |
|
|
|
41,635 |
|
Intangible assets, net |
|
6,719 |
|
|
|
6,875 |
|
Right-of-use assets |
|
73,682 |
|
|
|
73,462 |
|
Long-term investments |
|
29,433 |
|
|
|
25,283 |
|
Other long-term assets |
|
717 |
|
|
|
771 |
|
Total assets |
$ |
356,661 |
|
|
$ |
353,657 |
|
LIABILITIES AND
SHAREHOLDERS’ EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
19,432 |
|
|
$ |
22,347 |
|
Accrued expenses |
|
11,026 |
|
|
|
17,215 |
|
Current portion of operating lease liabilities |
|
6,012 |
|
|
|
6,187 |
|
Total current liabilities |
|
36,470 |
|
|
|
45,749 |
|
Operating lease liabilities |
|
86,141 |
|
|
|
81,856 |
|
Other long-term liabilities |
|
154 |
|
|
|
100 |
|
Total liabilities |
$ |
122,765 |
|
|
$ |
127,705 |
|
Total shareholders’ equity |
|
233,896 |
|
|
|
225,952 |
|
Total liabilities and shareholders’ equity |
$ |
356,661 |
|
|
$ |
353,657 |
|
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