Conference call begins at 4:30 p.m. Eastern
time today
Ra Medical Systems, Inc. (NYSE American: RMED), a medical device
company focusing on developing its excimer laser system to treat
vascular disease, reports financial results for the three months
and full year ended December 31, 2021 and provides a business
update.
Recent Operational Highlights
- Filed 510(k) application with the FDA for our next-generation
DABRA catheter that incorporates a braided overjacket designed to
improve robustness and includes data supporting a six-month shelf
life
- Enrolled 13 subjects in the company’s atherectomy pivotal
clinical study since mid-November 2021, for a total of 98 subjects
enrolled, and received approval from the FDA to increase study
enrollment from 100 to 125 subjects
- Preliminarily demonstrated the ability of our technology to
generate shockwaves that can fracture arterial medial calcium, a
procedure commonly referred to as intravascular lithotripsy, in
benchtop models
“I am pleased with the progress we are making on all key
initiatives,” said Will McGuire, Ra Medical Systems CEO. “First,
filing the 510(k) for our next-generation catheter that
incorporates the braided overjacket is a significant engineering
and regulatory stepping-stone toward our flagship commercial DABRA
catheter, which will be a guidewire-compatible design. Second, I’m
encouraged that we continued to advance subject enrollment in our
clinical study during the pandemic. And third, we believe that
fracturing medial calcium in benchtop models validated our system’s
potential to be competitive in the emerging intravascular
lithotripsy market.
“Finally, I want to commend the Ra Medical team for executing
during these unprecedented times and for the support of our
physician partners who have helped us achieve our milestones to
date,” added Mr. McGuire.
Fourth Quarter Financial Highlights
Net revenue for the fourth quarter of 2021 consisted of product
sales of $5,000, compared with no net revenue for the fourth
quarter of 2020.
Total cost of revenue for the fourth quarter of 2021 was $0.3
million, compared with $0.4 million for the fourth quarter of
2020.
Selling, general and administrative expenses for the fourth
quarter of 2021 were $4.2 million, which included $0.2 million in
stock-based compensation, compared with $6.4 million for the fourth
quarter of 2020, which included $0.8 million in stock-based
compensation. Research and development expenses for the fourth
quarter of 2021 were $3.7 million, which included $0.1 million in
stock-based compensation, compared with $3.4 million for the fourth
quarter of 2020, which included $0.1 million in stock-based
compensation.
The net operating loss for the fourth quarter of 2021 was $8.3
million, or $1.23 per share on 6.7 million weighted-average shares
outstanding, compared with a loss for the fourth quarter of 2020 of
$10.2 million, or $3.54 per share on 2.9 million weighted-average
shares outstanding.
Adjusted EBITDA for the fourth quarter of 2021 was negative $7.8
million, compared with negative $8.8 million for the fourth quarter
of 2020. Adjusted EBITDA is a non-GAAP measure presented as loss
from continuing operations before depreciation and amortization
expense, interest income, interest expense, income taxes,
stock-based compensation, gain and loss from sales and disposals of
property and equipment, and gain on extinguishment of the Paycheck
Protection Program (PPP) promissory note. For additional
information regarding the non-GAAP financial measures discussed in
this news release, please see "Non-GAAP Reconciliations" below.
2021 Financial Highlights
Continuing Operations
Net revenue for 2021 consisted of product sales of $22,000. This
compares with net revenue for 2020 of $0.3 million which consisted
primarily of product sales.
Total cost of revenue for 2021 was $1.6 million, compared with
$2.2 million for 2020.
Selling, general and administrative expenses for 2021 were $15.5
million, which included $1.8 million in stock-based compensation,
compared with $24.5 million for 2020, which included $3.2 million
in stock-based compensation. Research and development expenses for
2021 were $12.3 million, which included $0.3 million in stock-based
compensation, compared with $9.0 million for 2020, which included
$0.4 million in stock-based compensation.
Net operating loss for 2021 was $27.3 million, or $5.39 per
share on 5.1 million weighted-average shares outstanding, compared
with a loss for 2020 of $35.3 million, or $20.79 per share on 1.7
million weighted-average shares outstanding.
Adjusted EBITDA for 2021 was negative $26.5 million, compared
with negative $29.7 million for 2020. For additional information
regarding the non-GAAP financial measures discussed in this news
release, please see "Non-GAAP Reconciliations" below.
Ra Medical reported cash and cash equivalents of $15.0 million
as of December 31, 2021.
2021 Financial Highlights
Discontinued Operations
Net revenue for 2021 was $2.6 million, which consisted of
product sales of $0.9 million and service and other revenue of $1.7
million. This compares with net revenue for 2020 of $4.1 million,
which consisted of product sales of $1.1 million and service and
other revenue of $3.0 million.
Total cost of revenue for 2021 was $2.3 million, compared with
$3.3 million for 2020.
Selling, general and administrative expenses for 2021 were $1.1
million, compared with $1.4 million for 2020. Research and
development expenses for 2021 were $0.4 million, compared with $0.1
million for 2020.
The loss from discontinued operations for 2021 was $1.3 million,
compared with a loss for 2020 of $0.7 million.
The gain on sale of the dermatology business for 2021 was $3.5
million.
The income/loss from discontinued operations, including the gain
on sale of the dermatology business, for 2021 was income of $2.2
million, or $0.43 per share on 5.1 million weighted-average shares
outstanding, compared with a loss for 2020 of $0.7 million, or
$0.43 per share on 1.7 million weighted-average shares
outstanding.
Conference Call and Webcast
Ra Medical will hold a conference call and audio webcast to
discuss this announcement and answer questions at 4:30 p.m. Eastern
time today. The conference call dial-in numbers are 866-777-2509
for domestic callers and 412-317-5413 for international callers,
and the passcode is 9255498. A live webcast of the call will be
available on the Investor Relations section of www.ramed.com.
A recording of the call will be available for 48 hours beginning
approximately two hours after the completion of the call by dialing
877-344-7529 for domestic callers, 855-669-9658 for Canadian
callers or 412-317-0088 for international callers. Please use the
passcode 9255498. A webcast replay will be available on the
Investor Relations section of www.ramed.com for 30 days, beginning
approximately two hours after the completion of the call.
Non-GAAP Financial Measures
Ra Medical has presented certain financial information in
accordance with U.S. GAAP and also on a non-GAAP basis for the
three-month periods and full years ended December 31, 2021 and
2020. EBITDA and Adjusted EBITDA are performance measures that
provide supplemental information management believes is useful to
analysts and investors to evaluate Ra Medical’s ongoing results of
operations, when considered alongside other GAAP measures. These
measures are intended to aid investors in better understanding Ra
Medical’s current financial performance and prospects for the
future as seen through management. Management uses non-GAAP
measures to compare the company’s performance relative to forecasts
and strategic plans and to benchmark the company’s performance
externally against competitors. Management believes that these
non-GAAP financial measures facilitate comparisons with Ra
Medical’s historical results and with the results of peer companies
who present similar measures (although other companies may define
non-GAAP measures differently than we define them, even when
similar terms are used to identify such measures). Non-GAAP
information is not prepared under a comprehensive set of accounting
rules and should only be used to supplement an understanding of the
company’s operating results as reported under U.S. GAAP. Ra Medical
encourages investors to carefully consider its results under U.S.
GAAP, as well as its supplemental non-GAAP information and the
reconciliation between these presentations, to more fully
understand its business. Reconciliations between U.S. GAAP and
non-GAAP operating results are presented in the accompanying tables
of this news release.
Investors are encouraged to review the related U.S. GAAP
financial measures and the reconciliation of these non-GAAP
financial measures to their most directly comparable GAAP financial
measures, and not to rely on any single financial measure to
evaluate our business. Ra Medical defines EBITDA as our GAAP loss
from continuing operations as adjusted to exclude depreciation and
amortization, interest income, interest expense and income tax
expense. Ra Medical defines Adjusted EBITDA as EBITDA adjusted to
exclude stock-based compensation, gain on extinguishment of PPP
promissory note and gain/loss on sales and disposals of property
and equipment.
About Ra Medical Systems
Ra Medical Systems manufactures the DABRA excimer laser and
catheters for the treatment of vascular diseases. DABRA has been
cleared by the FDA for crossing chronic total occlusions in
patients with symptomatic infrainguinal lower extremity vascular
disease and has an intended use for ablating a channel in occlusive
peripheral vascular disease. In addition, DABRA has been granted CE
mark clearance for the endovascular treatment of infrainguinal
arteries via atherectomy and for crossing total occlusions. DABRA
breaks down plaque to proteins, lipids and other chemical
compounds, eliminating blockages by essentially dissolving them
without generating potentially harmful particulates. DABRA excimer
lasers and catheters are manufactured in a 32,000 square-foot
facility located in Carlsbad, CA. The vertically integrated
facility is ISO 13485 certified and is licensed by the State of
California to manufacture sterile, single-use catheters in clean
room environments.
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements generally relate to future events
or Ra Medical’s future financial or operating performance. In some
cases, you can identify forward-looking statements because they
contain words such as “may,” “will,” “should,” “expects,” “plans,”
“anticipates,” “could,” “intends,” “target,” “projects,”
“contemplates,” “believes,” “estimates,” “predicts,” “potential” or
“continue” or the negative of these words or other similar terms or
expressions that concern Ra Medical’s future expectations,
strategy, plans or intentions. Forward-looking statements in this
press release include, but are not limited to, statements regarding
Ra Medical’s business strategy, the potential of the DABRA system
for new applications of use, the market opportunity and growth of
current and potential markets and its ability to continue to manage
expenses and cash burn rate at sustainable levels. Ra Medical’s
expectations and beliefs regarding these matters may not
materialize, and actual results in future periods are subject to
risks and uncertainties that could cause actual results to differ
materially from those projected or implied by such forward-looking
statements. The potential risks and uncertainties which contribute
to the uncertain nature of these statements include, among others,
challenges inherent in developing, manufacturing, launching,
marketing, and selling new products or new applications of use;
risks associated with acceptance of DABRA devices for current and
potential applications of use and procedures performed using such
devices by physicians, payors, and other third parties; development
and acceptance of new products, product enhancements or
applications of use; clinical and statistical verification of the
benefits achieved via the use of Ra Medical’s products; the results
from our clinical trials, which may not support intended
indications or may require Ra Medical to conduct additional
clinical trials or modify ongoing clinical trials; challenges
related to commencement, patient enrollment, completion, an
analysis of clinical trials; Ra Medical’s ability to manage
operating expenses; Ra Medical’s ability to recruit and retain
management and key personnel; Ra Medical’s need to comply with
complex and evolving laws and regulations; intense and increasing
competition and consolidation in Ra Medical’s industry; the impact
of rapid technological change; adverse outcome of regulatory
inspections; impacts from public health crises, such as the
Covid-19 pandemic, geopolitical conflicts, such as Russia’s
invasion of Ukraine and related sanctions against Russia and
Belarus, or natural disasters; and the other risks and
uncertainties described in Ra Medical’s news releases and filings
with the Securities and Exchange Commission. Information on these
and additional risks, uncertainties, and other information
affecting Ra Medical’s business and operating results is contained
in Ra Medical’s Quarterly Report on Form 10-Q for the quarter ended
September 30, 2021 and in its other filings with the Securities and
Exchange Commission. Additional information is also set forth in Ra
Medical’s Annual Report on Form 10-K for the year ended December
31, 2021 to be filed with the Securities and Exchange Commission.
The forward-looking statements in this press release are based on
information available to Ra Medical as of the date hereof, and Ra
Medical disclaims any obligation to update any forward-looking
statements, except as required by law.
Ra Medical investors and others should note that we announce
material information to the public about the company through a
variety of means, including our website (www.ramed.com), our
investor relations website (https://ir.ramed.com/), press releases,
SEC filings and public conference calls in order to achieve broad,
non-exclusionary distribution of information to the public and to
comply with our disclosure obligations under Regulation FD. We
encourage our investors and others to monitor and review the
information we make public in these locations as such information
could be deemed to be material information. Please note that this
list may be updated from time to time.
Ra Medical Systems,
Inc.
Condensed Balance
Sheets
(Unaudited)
(in thousands)
December 31, 2021
December 31, 2020
ASSETS
Current Assets
Cash and cash equivalents
$
15,045
$
23,906
Accounts receivable, net
21
24
Inventories
986
877
Prepaid expenses and other current
assets
1,037
1,100
Current assets of discontinued
operations
—
1,713
Total current assets
17,089
27,620
Property and equipment, net
1,809
2,527
Operating lease right-of-use-assets
2,110
2,484
Other long-term assets
36
45
Long-term assets of discontinued
operations
—
762
TOTAL ASSETS
$
21,044
$
33,438
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current Liabilities
Accounts payable
$
988
$
471
Accrued expenses
4,119
4,147
Current portion of operating lease
liabilities
283
356
Current portion of PPP promissory note
—
421
Current portion of equipment financing
—
265
Current liabilities of discontinued
operations
—
2,102
Total current liabilities
5,390
7,762
Operating lease liabilities
1,981
2,264
PPP promissory note
—
1,579
Long-term liabilities of discontinued
operations
—
686
Total liabilities
7,371
12,291
Total stockholders’ equity
13,673
21,147
TOTAL LIABILITIES AND STOCKHOLDERS’
EQUITY
$
21,044
$
33,438
Ra Medical Systems,
Inc.
Condensed Statements of
Operations
(Unaudited)
(in thousands, except per
share data)
Three Months Ended December
31,
Year Ended December
31,
2021
2020
2021
2020
Net revenues
Product sales
$
5
$
—
$
22
$
254
Service and other
—
—
—
5
Total net revenues
5
—
22
259
Cost of revenues
Product sales
156
238
832
1,369
Service and other
191
188
728
803
Total cost of revenues
347
426
1,560
2,172
Gross loss
(342
)
(426
)
(1,538
)
(1,913
)
Operating expenses
Selling, general and administrative
4,190
6,379
15,475
24,533
Research and development
3,732
3,421
12,253
8,955
Total operating expenses
7,922
9,800
27,728
33,488
Operating loss
(8,264
)
(10,226
)
(29,266
)
(35,401
)
Other income (expense), net
(19
)
(9
)
2,009
88
Loss from continuing operations before
income taxes
(8,283
)
(10,235
)
(27,257
)
(35,313
)
Income taxes
4
7
4
7
Loss from continuing operations
(8,287
)
(10,242
)
(27,261
)
(35,320
)
Discontinued operations
(Loss) income from discontinued operations
(including gain on sale of $3,500 in 2021) before income taxes
—
(226
)
2,191
(725
)
Income taxes
—
—
—
—
(Loss) Income from discontinued
operations
—
(226
)
2,191
(725
)
Net loss
$
(8,287
)
$
(10,468
)
$
(25,070
)
$
(36,045
)
Net (loss) income per share, basic and
diluted
Continuing operations
$
(1.23
)
$
(3.54
)
$
(5.39
)
$
(20.79
)
Discontinued operations
—
(0.08
)
0.43
(0.43
)
Total net loss per share, basic and
diluted
$
(1.23
)
$
(3.62
)
$
(4.96
)
$
(21.22
)
Basic and diluted weighted average
common shares outstanding
6,742
2,895
5,055
1,699
Ra Medical Systems, Inc. Non-GAAP Reconciliations
(Unaudited) (in thousands) Three Months
EndedDecember 31, Year EndedDecember 31,
2021
2020
2021
2020
Statement of Operations Data: Loss from continuing
operations
$
(8,287
)
$
(10,242
)
$
(27,261
)
$
(35,320
)
Depreciation and amortization
315
417
1,289
1,947
Interest income
(1
)
(1
)
(3
)
(129
)
Interest expense
—
10
12
41
Income tax expense
4
7
4
7
EBITDA
(7,969
)
(9,809
)
(25,959
)
(33,454
)
Stock-based compensation
252
941
2,054
3,682
Gain on extinguishment of PPP promissory note
—
—
(2,023
)
—
(Gain) Loss on sales and disposals of property and equipment
(61
)
99
(550
)
99
Adjusted EBITDA
$
(7,778
)
$
(8,769
)
$
(26,478
)
$
(29,673
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220323005873/en/
At the Company: Andrew Jackson Chief Financial Officer,
Ra Medical Systems 760-496-9540 ajackson@ramed.com
Investors: LHA Investor Relations Jody Cain 310-691-7100
jcain@lhai.com
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