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 third
quarter ended September 30, 2023.
Third Quarter 2023 Financial Highlights
- Total net revenue of $45.6 million
- MACI® net revenue of $37.6 million, Epicel® net revenue of $7.4
million and NexoBrid® net revenue of $0.6 million
- Gross margin of 67%
- Net loss of $3.7 million, or $0.08 per diluted share
- Non-GAAP adjusted EBITDA of $5.4 million
- Operating cash flow of $7.2 million
- As of September 30, 2023, the Company had approximately $149
million in cash, restricted cash and investments, and no debt
Business Highlights and Updates
- Record third quarter total revenue, representing 18% growth
versus the prior year
- Year-to-date total revenue increased 19% to $132.5 million
- MACI third-quarter revenue growth of 21%, marking the fifth
straight quarter of 20%+ growth
- 13th straight quarter of positive adjusted EBITDA and operating
cash flow, with adjusted EBITDA growth of 64% versus the prior
year
- Record third-quarter highs for MACI biopsies and the number of
surgeons taking biopsies
- Completed human factors validation study for MACI arthroscopic
delivery program during the third quarter, with commercial launch
anticipated in the first half of 2024
- Announced U.S. commercial availability of NexoBrid,
significantly expanding the total addressable market for Vericel
Burn Care
- Announced publication of positive results from NexoBrid Phase 3
DETECT study in the Journal of Burn Care & Research,
demonstrating that treatment with NexoBrid resulted in early
complete eschar removal in more than 90% of treated burn patients
and reduced the need for surgical excision compared to Gel Vehicle
and standard of care
“The Company continued to execute well in the third quarter,
delivering strong financial results and achieving significant
milestones, and as a result we are once again raising our full-year
2023 revenue guidance,” said Nick Colangelo, President and CEO of
Vericel. “We believe that we are very well-positioned for a strong
close to the year and to generate even stronger financial results
in 2024 as we expect higher revenue growth next year driven by
continued strength in our core business and contributions from
NexoBrid and arthroscopic MACI, as well as significant margin
expansion driven by sustained strong revenue growth.”
2023 Financial Guidance
- Total net revenue for 2023 now expected to be in the range of
$192.5 to $197.5 million, compared to the previous guidance of $190
to $197 million
- Maintaining profitability guidance of gross margin in the
high-60% range and adjusted EBITDA margin in the mid-teens %
range
Third Quarter 2023 ResultsTotal net revenue for
the quarter ended September 30, 2023 increased 18% to $45.6
million, compared to $38.6 million in the third quarter of 2022.
Total net product revenue for the quarter included $37.6 million of
MACI (autologous cultured chondrocytes on porcine collagen
membrane) net revenue, $7.4 million of Epicel (cultured epidermal
autografts) net revenue, and $0.6 million of NexoBrid
(anacaulase-bcdb) net revenue compared to $31.0 million of MACI net
revenue, $7.3 million of Epicel net revenue, and $0.2 million of
NexoBrid net revenue, respectively, in the third quarter of
2022.
Gross profit for the quarter ended September 30, 2023 was $30.6
million, or 67% of net revenue, compared to $25.2 million, or 65%
of net revenue, for the third quarter of 2022.
Total operating expenses for the quarter ended September 30,
2023 were $35.7 million, compared to $32.0 million for the same
period in 2022. The increase in operating expenses was primarily
due to higher sales and marketing expenses and research and
development program costs.
Net loss for the quarter ended September 30, 2023 was $3.7
million, or $0.08 per diluted share, compared to $6.6 million, or
$0.14 per diluted share, for the third quarter of 2022.
Non-GAAP adjusted EBITDA for the quarter ended September 30,
2023 was $5.4 million, or 12% of net revenue, compared to $3.3
million, or 9% of net revenue, for the third quarter of 2022. A
table reconciling non-GAAP measures is included in this press
release for reference.
As of September 30, 2023, the Company had approximately $149
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 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 November 8, 2024.
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 and one
specialty biologic product 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® (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
(SEC). 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. and is used under license to Vericel Corporation. © 2023
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, 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
affecting MediWound Ltd.’s ability to manufacture and supply
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, 2022, filed with the Securities and Exchange
Commission (SEC) on February 23, 2023, Vericel’s Quarterly Report
on Form 10-Q for the quarter ended September 30, 2023, filed with
the SEC on November 8, 2023, 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 September 30, |
|
Nine months ended September 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Product sales, net |
|
$ |
45,581 |
|
|
$ |
38,326 |
|
|
$ |
132,520 |
|
|
$ |
111,004 |
|
Other revenue |
|
|
— |
|
|
|
225 |
|
|
|
— |
|
|
|
667 |
|
Total revenue |
|
|
45,581 |
|
|
|
38,551 |
|
|
|
132,520 |
|
|
|
111,671 |
|
Cost of product sales |
|
|
14,973 |
|
|
|
13,318 |
|
|
|
45,451 |
|
|
|
40,132 |
|
Gross profit |
|
|
30,608 |
|
|
|
25,233 |
|
|
|
87,069 |
|
|
|
71,539 |
|
Research and development |
|
|
5,676 |
|
|
|
5,046 |
|
|
|
16,141 |
|
|
|
14,698 |
|
Selling, general and administrative |
|
|
29,989 |
|
|
|
26,975 |
|
|
|
90,123 |
|
|
|
79,984 |
|
Total operating expenses |
|
|
35,665 |
|
|
|
32,021 |
|
|
|
106,264 |
|
|
|
94,682 |
|
Loss from operations |
|
|
(5,057 |
) |
|
|
(6,788 |
) |
|
|
(19,195 |
) |
|
|
(23,143 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
Interest income |
|
|
1,262 |
|
|
|
342 |
|
|
|
3,196 |
|
|
|
578 |
|
Interest expense |
|
|
(150 |
) |
|
|
(105 |
) |
|
|
(444 |
) |
|
|
(143 |
) |
Other (expense) income |
|
|
(1 |
) |
|
|
(5 |
) |
|
|
(18 |
) |
|
|
98 |
|
Total other income |
|
|
1,111 |
|
|
|
232 |
|
|
|
2,734 |
|
|
|
533 |
|
Loss before income taxes |
|
|
(3,946 |
) |
|
|
(6,556 |
) |
|
|
(16,461 |
) |
|
|
(22,610 |
) |
Income tax (benefit) expense |
|
|
(286 |
) |
|
|
21 |
|
|
|
(286 |
) |
|
|
21 |
|
Net loss |
|
$ |
(3,660 |
) |
|
$ |
(6,577 |
) |
|
$ |
(16,175 |
) |
|
$ |
(22,631 |
) |
Net loss per common
share: |
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.08 |
) |
|
$ |
(0.14 |
) |
|
$ |
(0.34 |
) |
|
$ |
(0.48 |
) |
Weighted-average common shares
outstanding: |
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
47,649 |
|
|
|
47,182 |
|
|
|
47,537 |
|
|
|
47,096 |
|
VERICEL CORPORATIONRECONCILIATION OF
REPORTED NET LOSS (GAAP) TO ADJUSTED EBITDA
(NON-GAAP MEASURE)(in thousands -
unaudited) |
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Net loss |
|
$ |
(3,660 |
) |
|
$ |
(6,577 |
) |
|
$ |
(16,175 |
) |
|
$ |
(22,631 |
) |
Stock-based compensation expense |
|
|
7,924 |
|
|
|
9,104 |
|
|
|
25,416 |
|
|
|
29,443 |
|
Depreciation and amortization |
|
|
1,154 |
|
|
|
1,014 |
|
|
|
3,483 |
|
|
|
2,942 |
|
Net interest income |
|
|
(1,112 |
) |
|
|
(237 |
) |
|
|
(2,752 |
) |
|
|
(435 |
) |
Income tax (benefit) expense |
|
|
(286 |
) |
|
|
21 |
|
|
|
(286 |
) |
|
|
21 |
|
Pre-occupancy lease expense |
|
|
1,424 |
|
|
|
— |
|
|
|
1,899 |
|
|
|
— |
|
Adjusted EBITDA
(Non-GAAP) |
|
$ |
5,444 |
|
|
$ |
3,325 |
|
|
$ |
11,585 |
|
|
$ |
9,340 |
|
VERICEL CORPORATIONCONDENSED CONSOLIDATED
BALANCE SHEETS(in thousands -
unaudited) |
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
|
2023 |
|
|
2022 |
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
60,473 |
|
$ |
51,067 |
Restricted cash |
|
|
23,088 |
|
|
— |
Short-term investments |
|
|
44,870 |
|
|
68,471 |
Accounts receivable (net of allowance for doubtful accounts of $44
and $47, respectively) |
|
|
39,729 |
|
|
46,539 |
Inventory |
|
|
12,621 |
|
|
15,986 |
Other current assets |
|
|
5,430 |
|
|
4,803 |
Total current assets |
|
|
186,211 |
|
|
186,866 |
Property and equipment, net |
|
|
30,216 |
|
|
15,837 |
Intangible assets, net |
|
|
7,031 |
|
|
7,500 |
Right-of-use assets |
|
|
73,294 |
|
|
41,535 |
Long-term investments |
|
|
20,231 |
|
|
19,962 |
Other long-term assets |
|
|
1,142 |
|
|
1,303 |
Total assets |
|
$ |
318,125 |
|
$ |
273,003 |
LIABILITIES AND
SHAREHOLDERS’ EQUITY |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
15,051 |
|
$ |
16,930 |
Accrued expenses |
|
|
13,628 |
|
|
16,190 |
Current portion of operating lease liabilities |
|
|
7,267 |
|
|
4,302 |
Other current liabilities |
|
|
— |
|
|
41 |
Total current liabilities |
|
|
35,946 |
|
|
37,463 |
Operating lease liabilities |
|
|
77,734 |
|
|
43,268 |
Other long-term liabilities |
|
|
65 |
|
|
— |
Total liabilities |
|
$ |
113,745 |
|
$ |
80,731 |
Total shareholders’ equity |
|
|
204,380 |
|
|
192,272 |
Total liabilities and shareholders’ equity |
|
$ |
318,125 |
|
$ |
273,003 |
Vericel (NASDAQ:VCEL)
Graphique Historique de l'Action
De Déc 2024 à Jan 2025
Vericel (NASDAQ:VCEL)
Graphique Historique de l'Action
De Jan 2024 à Jan 2025