Ra Medical Systems, Inc. (NYSE:
RMED), a medical device company focusing on commercializing excimer
laser systems to treat vascular and dermatological diseases,
reports financial results for the three and nine months ended
September 30, 2019.
Recent Operational Highlights
- Launched the new Pharos, Optimized dermatology laser (July
2019), which delivers extended peak performance and faster
treatment times.
- Announced the publication of a case report in Endovascular
Today (August 2019) by Rajesh M. Dave, MD, in which a complex
clinical challenge of isolated popliteal artery disease was
successfully tackled with excimer laser photoablation and
percutaneous balloon angioplasty.
- Announced the publication of a case report in Endovascular
Today (September 2019) by Mubashar Choudry, MD, FACC, Rashid A
Chotani, MD, MPH, FRCPH, James Rothstein, MD, and Amit Kumar
Rajvanshi, MD, entitled “Severe Common Femoral Artery Disease and
Failed Femoropopliteal Artery Graft: Amputation avoided through use
of DABRA excimer laser in an OBL setting.”
Third Quarter Financial Highlights
Net revenue for the third quarter of 2019 was $1.9 million,
which consisted of product sales of $1.1 million and service and
other revenue of $0.8 million. This compares with net revenue of
$2.1 million for the third quarter of 2018, which consisted of
product sales of $1.3 million and service and other revenue of $0.8
million.
Net revenue from the vascular segment for the third quarter of
2019 was $0.2 million, compared with $0.8 million for the third
quarter of 2018. Net revenue from the dermatology segment for the
third quarter of 2019 was $1.7 million, compared with $1.3 million
for the third quarter of 2018.
Total cost of revenue for the third quarter of 2019 was $2.4
million, compared with $1.3 million for the third quarter of
2018.
Selling, general and administrative expenses for the third
quarter of 2019 were $15.9 million, which included $6.6 million in
stock-based compensation expense compared with $5.4 million for the
third quarter of 2018, which included $1.4 million in stock-based
compensation expense. Research and development expenses for the
third quarter of 2019 were $1.2 million, which included $0.3
million in stock-based compensation expense, compared with $0.2
million for the third quarter in 2018, which included $0.1 million
in stock-based compensation expense.
The net loss for the third quarter of 2019 was $17.4 million, or
$1.30 per share, compared with a net loss for the third quarter of
2018 of $4.8 million, or $0.59 per share.
Adjusted EBITDA for the third quarter of 2019 was negative $9.9
million, compared with adjusted EBITDA of negative $3.1 million for
the third quarter of 2018. Adjusted EBITDA is a non-GAAP measure
presented as net loss before depreciation and amortization expense,
interest income, interest expense, income taxes and stock-based
compensation expense. For additional information regarding the
non-GAAP financial measures discussed in this news release, please
see "Non-GAAP Reconciliations" below.
Ra Medical reported cash, cash equivalents and short-term
investments of $40.5 million as of September 30, 2019.
Nine Months Financial Highlights
Net revenue for the first nine months of 2019 was $5.8 million,
which consisted of product sales of $3.3 million and service and
other revenue of $2.5 million. This compares with net revenue of
$4.3 million for the first nine months of 2018, which consisted of
product sales of $2.0 million and service and other revenue of $2.3
million.
Net revenue from the vascular segment for the first nine months
of 2019 was $1.1 million, compared with $1.0 million for the first
nine months of 2018. Net revenue from the dermatology segment for
the first nine months of 2019 was $4.7 million, compared with $3.3
million for the first nine months of 2018.
Total cost of revenue for the first nine months of 2019 was $7.1
million, compared with $3.0 million for the first nine months of
2018.
Selling, general and administrative expenses for the first nine
months of 2019 were $42.9 million, which included $19.3 million in
stock-based compensation expense, compared with $15.6 million for
the first nine months of 2018, which included $5.3 million in
stock-based compensation expense. Research and development expenses
for the first nine months of 2019 were $3.7 million, which included
$1.4 million in stock-based compensation expense, compared with
$1.5 million for the first nine months of 2018, which included $1.0
million in stock-based compensation expense.
The net loss for the first nine months of 2019 was $47.2
million, or $3.63 per share, compared with a net loss for the first
nine months of 2018 of $15.9 million, or $1.97 per share.
Adjusted EBITDA for the first nine months of 2019 was negative
$24.4 million, compared with adjusted EBITDA of negative $8.8
million for the first nine months of 2018. Adjusted EBITDA is a
non-GAAP measure presented as net loss before depreciation and
amortization expense, interest income, interest expense, income
taxes and stock-based compensation expense. For additional
information regarding the non-GAAP financial measures discussed in
this news release, please see "Non-GAAP Reconciliations" below.
About Ra Medical Systems
Ra Medical Systems commercializes excimer lasers and catheters
for the treatment of vascular and dermatological diseases. In May
2017, the DABRA laser system and single-use DABRA catheter received
FDA 510(k) clearance in the U.S. as a device for crossing chronic
total occlusions, or CTOs, in patients with symptomatic
infrainguinal lower extremity vascular disease with an intended use
for ablating a channel in occlusive peripheral vascular disease.
Pharos excimer laser system is FDA-cleared and is used as a tool in
the treatment of psoriasis, vitiligo, atopic dermatitis, and
leukoderma. DABRA and Pharos are both based on Ra Medical’s core
excimer laser technology platform and deploy similar mechanisms of
action. Ra Medical manufactures DABRA and Pharos excimer lasers and
catheters in a 32,000-square-foot facility located in Carlsbad,
California. The vertically integrated facility is ISO 13485
certified and is licensed by the state of California to manufacture
sterile, single-use catheters in controlled environments.
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 and nine month periods ended September 30, 2019 and 2018.
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 GAAP,
as well as its supplemental non-GAAP information and the
reconciliation between these presentations, to more fully
understand its business. Reconciliations between GAAP and non-GAAP
operating results are presented in the accompanying tables of this
release.
Investors are encouraged to review the related 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 net loss as
adjusted to exclude depreciation and amortization, interest income,
interest expense and income tax expense. Ra Medical defines
Adjusted EBITDA as our GAAP net loss as adjusted to exclude
depreciation and amortization, interest income, interest expense,
income tax expense and stock-based compensation.
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. 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; risks associated with acceptance of DABRA and
Pharos and procedures performed using such devices by physicians,
payors, and other third parties; development and acceptance of new
products or product enhancements; 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 effectively manage
inventory; 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; costs and adverse results in any ongoing or
future legal proceedings; adverse outcome of regulatory
inspections; 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 Annual
Report on Form 10-K for the year ended December 31, 2018 and in its
other filings with the Securities and Exchange Commission.
Additional information will also be set forth in Ra Medical’s
Quarterly Report on Form 10-Q for the quarter ended September 30,
2019 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)
September 30,
2019
December 31,
2018
ASSETS
Current Assets
Cash and cash equivalents
$
14,512
$
64,315
Short-term investments
25,964
—
Accounts receivable, net
1,296
1,320
Inventories
2,572
2,097
Prepaid expenses and other current
assets
1,108
1,501
Total current assets
45,452
69,233
Property and equipment, net
5,418
4,757
Operating lease right-of-use-assets
2,919
—
Other non-current assets
213
45
TOTAL ASSETS
$
54,002
$
74,035
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current Liabilities
Accounts payable
$
1,004
$
1,125
Accrued expenses
4,386
2,809
Current portion of deferred revenue
1,917
1,723
Current portion of equipment financing
366
293
Current portion of operating lease
liabilities
309
—
Total current liabilities
7,982
5,950
Deferred revenue
1,161
767
Equipment financing
417
557
Operating lease liabilities
2,701
—
Other liabilities
—
56
Total liabilities
12,261
7,330
Total stockholders’ equity
41,741
66,705
TOTAL LIABILITIES AND STOCKHOLDERS’
EQUITY
$
54,002
$
74,035
Ra Medical Systems,
Inc.
Condensed Statements of
Operations
(Unaudited)
(in thousands, except per
share data)
Three Months Ended September
30,
Nine Months Ended September
30,
2019
2018
2019
2018
Net revenue
Product sales
$
1,078
$
1,248
$
3,256
$
1,958
Service and other
830
816
2,553
2,311
Total net revenue
1,908
2,064
5,809
4,269
Cost of revenue
Product sales
1,518
886
4,848
1,875
Service and other
907
394
2,252
1,131
Total cost of revenue
2,425
1,280
7,100
3,006
Gross (loss) profit
(517
)
784
(1,291
)
1,263
Operating expenses
Selling, general and administrative
15,889
5,366
42,907
15,621
Research and development
1,182
224
3,692
1,532
Total operating expenses
17,071
5,590
46,599
17,153
Operating loss
(17,588
)
(4,806
)
(47,890
)
(15,890
)
Other income (expense), net
173
(1
)
684
(2
)
Loss before income tax expense
(17,415
)
(4,807
)
(47,206
)
(15,892
)
Income tax expense
3
—
8
3
Net loss
$
(17,418
)
$
(4,807
)
$
(47,214
)
$
(15,895
)
Basic and diluted net loss per
share
$
(1.30
)
$
(0.59
)
$
(3.63
)
$
(1.97
)
Basic and diluted weighted average
common shares outstanding
13,370
8,204
13,023
8,081
Ra Medical Systems,
Inc.
Non-GAAP
Reconciliations
(in thousands)
(unaudited)
Three Months Ended September
30,
Nine Months Ended September
30,
2019
2018
2019
2018
Statement of Operations Data:
Net loss
$
(17,418
)
$
(4,707
)
$
(47,214
)
$
(15,895
)
Depreciation and amortization
460
157
1,291
388
Interest income
(245
)
—
(870
)
—
Interest expense
72
1
186
2
Income tax expense
3
—
8
3
EBITDA
(17,128
)
(4,649
)
(46,599
)
(15,502
)
Stock-based compensation
7,277
1,510
22,154
6,714
Adjusted EBITDA
$
(9,851
)
$
(3,139
)
$
(24,445
)
$
(8,788
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191129005102/en/
At the Company: Jeffrey Kraws
President, Ra Medical Systems 760-707-7516 jkraws@ramed.com
Investors and Media: LHA Investor
Relations Jody Cain / Kevin McCabe 310-691-7100 jcain@lhai.com / kmccabe@lhai.com
Ra Medical Systems (NYSE:RMED)
Historical Stock Chart
From Mar 2024 to Apr 2024
Ra Medical Systems (NYSE:RMED)
Historical Stock Chart
From Apr 2023 to Apr 2024