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 second
quarter ended June 30, 2023, and provided updated full-year 2023
financial guidance.
Second Quarter 2023 Financial Highlights
- Total net revenue of $45.9
million
- MACI® net revenue of $36.3 million
and Epicel® net revenue of $9.6 million
- Gross margin of 65%
- Net loss of $5.0 million, or $0.11
per diluted share
- Non-GAAP adjusted EBITDA of $4.4
million
- Operating cash flow of $10.2
million
- As of June 30, 2023, the Company had
approximately $147 million in cash, restricted cash and
investments, and no debt
Business Highlights and Updates
- Record second quarter total revenue of $45.9 million,
representing 24% growth versus the prior year
- MACI second-quarter revenue growth of 27%, representing the
fourth straight quarter of 20%+ growth compared to the prior
year
- MACI revenue growth of 29% in the first half of 2023 versus the
prior year
- Highest number of surgeons taking MACI biopsies in a quarter
and second highest number of MACI biopsies in a quarter since
launch
- Second quarter Epicel growth of 17% versus the prior year and
40% sequential growth versus the first quarter
- 12th straight quarter of positive adjusted EBITDA and operating
cash flow, with adjusted EBITDA growth of 60% in the second quarter
versus the prior year
- Human factors validation study for MACI arthroscopic delivery
program planned for Q3 and program remains on track for an
anticipated 2024 commercial launch; market research confirms
significant opportunity with high level of surgeon interest
- Executed long-term extension of exclusive supply agreement with
Matricel GmbH for the MACI ACI-Maix collagen membrane
“The Company continues to execute well, generating very strong
revenue growth for both MACI and Epicel in the second quarter, as
well as our 12th consecutive quarter of positive adjusted EBITDA
and operating cash flow,” said Nick Colangelo, President and CEO of
Vericel. “The underlying growth drivers of our business remain
strong, as evidenced by our outstanding performance in the first
half of the year and, as a result, we are increasing our total net
revenue guidance for the full year. We look forward to building on
this momentum as we expect a further acceleration in total company
revenue growth in 2024 driven by the planned launch of arthroscopic
MACI and a significant contribution from NexoBrid.”
2023 Financial Guidance
- Total net revenue for 2023 now
expected to be in the range of $190 to $197 million compared to the
previous guidance of $184 to $192 million
- Maintaining profitability guidance
of gross margin in the high-60% range and adjusted EBITDA margin in
the mid-teens % range
Second Quarter 2023 ResultsTotal net revenue
for the quarter ended June 30, 2023 increased 24% to $45.9 million,
compared to $37.0 million in the second quarter of 2022. Total net
product revenue for the quarter included $36.3 million of MACI
(autologous cultured chondrocytes on porcine collagen membrane) net
revenue and $9.6 million of Epicel (cultured epidermal autografts)
net revenue, compared to $28.6 million of MACI net revenue, $8.2
million of Epicel net revenue, and $0.2 million of NexoBrid
(anacaulase-bcdb) net revenue, respectively, in the second quarter
of 2022.
Gross profit for the quarter ended June 30, 2023 was $29.9
million, or 65% of net revenue, compared to $22.9 million, or 62%
of net revenue, for the second quarter of 2022.
Total operating expenses for the quarter ended June 30, 2023
were $35.9 million, compared to $31.9 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 June 30, 2023 was $5.0 million,
or $0.11 per diluted share, compared to $9.0 million, or $0.19 per
diluted share, for the second quarter of 2022.
Non-GAAP adjusted EBITDA for the quarter ended June 30, 2023 was
$4.4 million, or 10% of net revenue, compared to $2.8 million, or
7% of net revenue, for the second quarter of 2022. A table
reconciling non-GAAP measures is included in this press release for
reference.
As of June 30, 2023, the Company had approximately $147 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 August 2, 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.
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, the ultimate timing of the
commercial launch of NexoBrid in the United States, 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, negative impacts on the global
economy and capital markets resulting from the conflict in Ukraine,
global geopolitical tensions or record inflation and potential
future impacts of the COVID-19 pandemic on our business or the
economy generally.
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 June 30, 2023, filed with the
SEC on August 2, 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 CORPORATION |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
(in thousands, except per share amounts -
unaudited) |
|
|
|
Three Months Ended June 30, |
|
Six months ended June 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Product sales, net |
|
$ |
45,922 |
|
|
$ |
36,826 |
|
|
$ |
86,939 |
|
|
$ |
72,678 |
|
Other revenue |
|
|
— |
|
|
|
220 |
|
|
|
— |
|
|
|
442 |
|
Total revenue |
|
|
45,922 |
|
|
|
37,046 |
|
|
|
86,939 |
|
|
|
73,120 |
|
Cost of product sales |
|
|
15,981 |
|
|
|
14,192 |
|
|
|
30,478 |
|
|
|
26,814 |
|
Gross profit |
|
|
29,941 |
|
|
|
22,854 |
|
|
|
56,461 |
|
|
|
46,306 |
|
Research and development |
|
|
5,253 |
|
|
|
4,792 |
|
|
|
10,465 |
|
|
|
9,652 |
|
Selling, general and administrative |
|
|
30,649 |
|
|
|
27,144 |
|
|
|
60,134 |
|
|
|
53,009 |
|
Total operating expenses |
|
|
35,902 |
|
|
|
31,936 |
|
|
|
70,599 |
|
|
|
62,661 |
|
Loss from operations |
|
|
(5,961 |
) |
|
|
(9,082 |
) |
|
|
(14,138 |
) |
|
|
(16,355 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
Interest income |
|
|
1,095 |
|
|
|
148 |
|
|
|
1,934 |
|
|
|
236 |
|
Interest expense |
|
|
(149 |
) |
|
|
(20 |
) |
|
|
(294 |
) |
|
|
(38 |
) |
Other (expense) income |
|
|
(5 |
) |
|
|
(9 |
) |
|
|
(17 |
) |
|
|
103 |
|
Total other income |
|
|
941 |
|
|
|
119 |
|
|
|
1,623 |
|
|
|
301 |
|
Net loss |
|
$ |
(5,020 |
) |
|
$ |
(8,963 |
) |
|
$ |
(12,515 |
) |
|
$ |
(16,054 |
) |
Net loss per common
share: |
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.11 |
) |
|
$ |
(0.19 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.34 |
) |
Weighted-average common shares
outstanding: |
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
47,572 |
|
|
|
47,117 |
|
|
|
47,480 |
|
|
|
47,052 |
|
VERICEL CORPORATION |
RECONCILIATION OF REPORTED NET LOSS (GAAP) |
TO ADJUSTED EBITDA (NON-GAAP MEASURE) |
(in thousands - unaudited) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six months ended June 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Net loss |
|
$ |
(5,020 |
) |
|
$ |
(8,963 |
) |
|
$ |
(12,515 |
) |
|
$ |
(16,054 |
) |
Stock-based compensation expense |
|
|
8,761 |
|
|
|
10,808 |
|
|
|
17,492 |
|
|
|
20,339 |
|
Depreciation and amortization |
|
|
1,171 |
|
|
|
1,055 |
|
|
|
2,329 |
|
|
|
1,928 |
|
Net interest income |
|
|
(946 |
) |
|
|
(128 |
) |
|
|
(1,640 |
) |
|
|
(198 |
) |
Pre-occupancy lease expense |
|
|
475 |
|
|
|
— |
|
|
|
475 |
|
|
|
— |
|
Adjusted EBITDA
(Non-GAAP) |
|
$ |
4,441 |
|
|
$ |
2,772 |
|
|
$ |
6,141 |
|
|
$ |
6,015 |
|
VERICEL CORPORATION |
CONDENSED CONSOLIDATED BALANCE SHEETS |
(in thousands - unaudited) |
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
43,023 |
|
|
$ |
51,067 |
|
Restricted cash |
|
|
27,794 |
|
|
|
— |
|
Short-term investments |
|
|
54,808 |
|
|
|
68,471 |
|
Accounts receivable (net of allowance for doubtful accounts of $44
and $47, respectively) |
|
|
38,319 |
|
|
|
46,539 |
|
Inventory |
|
|
13,883 |
|
|
|
15,986 |
|
Other current assets |
|
|
5,044 |
|
|
|
4,803 |
|
Total current assets |
|
|
182,871 |
|
|
|
186,866 |
|
Property and equipment, net |
|
|
23,408 |
|
|
|
15,837 |
|
Intangible assets, net |
|
|
7,188 |
|
|
|
7,500 |
|
Right-of-use assets |
|
|
75,063 |
|
|
|
41,535 |
|
Long-term investments |
|
|
20,985 |
|
|
|
19,962 |
|
Other long-term assets |
|
|
1,196 |
|
|
|
1,303 |
|
Total assets |
|
$ |
310,711 |
|
|
$ |
273,003 |
|
LIABILITIES AND
SHAREHOLDERS’ EQUITY |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
14,401 |
|
|
$ |
16,930 |
|
Accrued expenses |
|
|
13,971 |
|
|
|
16,190 |
|
Current portion of operating lease liabilities |
|
|
7,218 |
|
|
|
4,302 |
|
Other current liabilities |
|
|
21 |
|
|
|
41 |
|
Total current liabilities |
|
|
35,611 |
|
|
|
37,463 |
|
Operating lease liabilities |
|
|
76,144 |
|
|
|
43,268 |
|
Other long-term liabilities |
|
|
28 |
|
|
|
— |
|
Total liabilities |
|
$ |
111,783 |
|
|
$ |
80,731 |
|
Total shareholders’ equity |
|
|
198,928 |
|
|
|
192,272 |
|
Total liabilities and shareholders’ equity |
|
$ |
310,711 |
|
|
$ |
273,003 |
|
Grafico Azioni Vericel (NASDAQ:VCEL)
Storico
Da Apr 2024 a Mag 2024
Grafico Azioni Vericel (NASDAQ:VCEL)
Storico
Da Mag 2023 a Mag 2024