Conference call begins at 4:30 p.m. Eastern
time today
Ra Medical Systems, Inc. (NYSE American: RMED) (“Ra Medical” or
“the Company”), a medical device company focusing on developing its
excimer laser system to treat vascular disease, reports financial
results for the three months ended March 31, 2022 and provides a
business update.
Recent Operational Highlights
Business and operational highlights from the first quarter of
2022 and recent weeks include the following:
- Increased enrollment to 107 subjects and opened one new
clinical site in the Company’s pivotal clinical trial to obtain an
atherectomy indication from the U.S. Food and Drug Administration
(FDA) for its DABRA excimer laser system
- Completed an underwritten public offering of common stock and
warrants for net proceeds of approximately $9.7 million
- Filed a 510(k) application with the FDA for a next-generation
DABRA catheter with a braided overjacket and a six-month shelf
life, with an intended use for ablating a channel in occlusive
peripheral vascular disease
- Constructed two working catheter prototypes designed to conduct
intravascular lithotripsy with the Company’s laser technology
- Granted a U.S. patent for a support catheter used with a small
flexible liquid core catheter for laser ablation of arterial plaque
blockages, and a U.S. patent for a liquid-filled laser ablation
catheter with an increased ablation surface area at the distal tip,
bringing to 11 the number of U.S. patents issued to the
Company
- Engaged an investment bank as part of the Company’s review of
strategic alternatives
“I’m encouraged by recent progress in our pivotal atherectomy
clinical trial with 107 of the planned 125 subjects now enrolled,
including 9 since our last update in late March,” said Will
McGuire, Ra Medical Systems CEO. “In addition, we continue to work
with the FDA to support their review of the 510(k) application we
submitted in February for our next-generation DABRA 2.0 catheter.
Finally, given the current economic environment, management and our
board of directors are conducting a review of strategic
alternatives and we have engaged an investment bank as a part of
this process with the goal of maximizing shareholder value. I look
forward to providing further details about this process when
appropriate.”
First Quarter Financial Highlights
Revenues for the first quarter of 2022 consisted of product
sales of $9,000, compared with product sales of $4,000 for the
first quarter of 2021.
Total cost of revenues for the first quarter of 2022 was $0.1
million, compared with $0.4 million for the first quarter of
2021.
Selling, general and administrative expenses for the first
quarter of 2022 were $2.3 million, which included $0.1 million in
stock-based compensation, compared with $3.7 million for the first
quarter of 2021, which included $0.9 million in stock-based
compensation. Research and development expenses for the first
quarter of 2022 were $3.1 million, which included $49,000 in
stock-based compensation, compared with $2.8 million for the first
quarter of 2021, which included $0.1 million in stock-based
compensation.
The loss from continuing operations for the first quarter of
2022 was $5.5 million, or $0.27 per share on 20.0 million
weighted-average shares outstanding. This compared with a loss from
continuing operations for the first quarter of 2021 of $6.9
million, or $2.36 per share on 2.9 million weighted-average shares
outstanding. Loss from discontinued operations was $0.4 million for
the first quarter of 2021.
Adjusted EBITDA for the first quarter of 2022 was negative $5.1
million, compared with negative $6.0 million for the first quarter
of 2021. Adjusted EBITDA is a non-GAAP measure presented as loss
from continuing operations before depreciation and amortization
expense, interest income, interest expense, income tax expense,
stock-based compensation and gain and loss from sales and disposals
of property and equipment. 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 $17.7 million
as of March 31, 2022. In February 2022, the Company raised net
proceeds of $9.7 million from a public offering after deducting
offering costs paid and payable as of March 31, 2022.
Conference Call and Webcast
Ra Medical will hold a conference call to discuss this
announcement and answer questions at 4:30 p.m. Eastern time today.
Participants can pre-register for the conference call here. Callers
who pre-register will be given a conference passcode and unique PIN
to gain immediate access to the call and bypass the live operator.
Participants may pre-register at any time, including up to and
after the call start time.
Interested parties may also participate on the conference call
by dialing 866-777-2509 for domestic callers and 412-317-5413 for
international callers, and requesting the Ra Medical Systems call.
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 6866135. 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 ended March 31, 2022 and 2021. 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, and gain and loss from 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, obtaining regulatory approvals, and selling new products
or new applications or indications 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; challenges in evaluating and
reviewing any strategic alternatives as well as our ability to
commence or consummate any such strategic transaction; 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 March 31, 2022 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 filed with the Securities and Exchange
Commission on March 24, 2022. 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)
March 31, 2022
December 31, 2021
ASSETS
Current Assets
Cash and cash equivalents
$
17,652
$
15,045
Accounts receivable, net
26
21
Inventories
1,059
986
Prepaid expenses and other current
assets
1,277
1,037
Total current assets
20,014
17,089
Property and equipment, net
1,658
1,809
Operating lease right-of-use assets
2,039
2,110
Other long-term assets
36
36
TOTAL ASSETS
$
23,747
$
21,044
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current Liabilities
Accounts payable
$
1,171
$
988
Accrued expenses
2,273
4,119
Current portion of operating lease
liabilities
291
283
Total current liabilities
3,735
5,390
Operating lease liabilities
1,904
1,981
Total liabilities
5,639
7,371
Total stockholders’ equity
18,108
13,673
TOTAL LIABILITIES AND STOCKHOLDERS’
EQUITY
$
23,747
$
21,044
Ra Medical Systems,
Inc.
Condensed Statements of
Operations
(Unaudited)
(in thousands, except per
share data)
Three Months Ended March
31,
2022
2021
Revenues
Product sales
$
9
$
4
Cost of revenues
Product sales
31
264
Service and other
64
183
Total cost of revenues
95
447
Gross loss
(86
)
(443
)
Operating expenses
Selling, general and administrative
2,302
3,677
Research and development
3,115
2,750
Total operating expenses
5,417
6,427
Operating loss
(5,503
)
(6,870
)
Other income (expense), net
8
(7
)
Loss from continuing operations before
income taxes
(5,495
)
(6,877
)
Income taxes
—
—
Loss from continuing operations
(5,495
)
(6,877
)
Discontinued operations
Loss from discontinued operations before
income taxes
—
(359
)
Income taxes
—
—
Loss from discontinued
operations
—
(359
)
Net loss
$
(5,495
)
$
(7,236
)
Net loss per share, basic and
diluted
Continuing operations
$
(0.27
)
$
(2.36
)
Discontinued operations
—
(0.12
)
Total net loss per share, basic and
diluted
$
(0.27
)
$
(2.48
)
Weighted average number of shares used
in computing net loss per share, basic and diluted
20,037
2,917
Ra Medical Systems,
Inc.
Non-GAAP
Reconciliations
(Unaudited)
(in thousands)
Three Months Ended March
31,
2022
2021
Statements of Operations Data:
Loss from continuing operations
$
(5,495
)
$
(6,877
)
Depreciation and amortization
186
334
Interest income
(1
)
(1
)
Interest expense
—
8
EBITDA
(5,310
)
(6,536
)
Stock-based compensation
162
1,072
Loss (gain) on sales and disposals of
property and equipment
36
(501
)
Adjusted EBITDA
$
(5,112
)
$
(5,965
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220516005933/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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