Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on
reducing the risk of stroke and its devastating impact, today
reported financial results for the three months and full year ended
December 31, 2023.
“With the right team in place, broad reimbursement, and
extensive evidence in support of TCAR, we are laser focused on
deepening adoption in physicians who perform TCAR,” said Chas
McKhann, CEO of Silk Road Medical. “My experience thus far at Silk
Road has only served to further validate the vast opportunity that
we see for TCAR to benefit many more patients with carotid artery
disease, and I’m excited by the underlying progress we are already
making towards that end.”
Recent Business Highlights
- Completed more than 25,000 TCAR procedures in 2023, bringing
the cumulative total to over 85,000
- Received expanded coverage for TCAR under a revised national
coverage decision issued by CMS, further expanding access to TCAR
and reducing administrative barriers
- Initiated the limited market release of new tapered
configurations for the Company’s ENROUTE Transcarotid Stent
System
- Executed distribution agreements with Medico’s Hirata in Japan
and Genesis MedTech Group in China following clearance for the
Company’s ENROUTE Stent and ENROUTE Neuroprotection System in both
countries
Fourth Quarter 2023 Financial ResultsRevenue
for the fourth quarter of 2023 was $47.3 million, an increase of
$7.2 million or 18%, as compared to the fourth quarter of 2022.
Growth was driven primarily by increased TCAR adoption.
Gross profit for the fourth quarter of 2023 was
$34.8 million compared to $29.1 million for the fourth quarter of
2022. Gross margin for the fourth quarter of 2023 increased to 74%
compared to 73% for the fourth quarter of 2022, primarily due to an
increase in production volumes.
Operating expenses were $49.2 million for the
fourth quarter of 2023 compared to $41.7 million in the fourth
quarter of 2022, which represents an increase of 18%. The increase
was primarily driven by increased headcount.
Net loss was $13.0 million for the fourth quarter of 2023, or a
loss of $0.33 per share, as compared to a loss of $12.6 million, or
$0.34 per share, for the fourth quarter of 2022.
Adjusted EBITDA was a loss of $4.1 million for the fourth
quarter of 2023 compared to a loss of $4.4 million for the fourth
quarter of 2022.
For additional information regarding non-GAAP financial
measures, see “Use of Non-GAAP Financial Measures” and
“Reconciliation of GAAP Net Loss to Adjusted EBITDA” below.
Full Year 2023 Financial ResultsRevenue for the
full year 2023 was $177.1 million, an increase of $38.5 million or
28%, as compared to 2022. The increase was driven primarily by
increased TCAR adoption.
Gross profit for the full year 2023 was $127.1
million compared to $100.8 million for 2022. Gross margin for the
full year 2023 decreased to 72% compared to 73% in 2022. The
decrease in gross margin was driven primarily by unfavorable
production variances.
Operating expenses were $186.4 million for the full year 2023,
compared to $152.8 million for 2022, which represents an increase
of 22%. The increase was primarily driven by increased
headcount.
Net loss was $55.7 million in the full year 2023, or a loss of
$1.44 per share, as compared to a loss of $55.0 million, or $1.54
per share, for 2022.
Adjusted EBITDA was a loss of $17.7 million for the full year
2023, compared to a loss of $25.1 million for 2022.
Cash, cash equivalents and investments were $190.9 million as of
December 31, 2023.
2024 Financial GuidanceSilk Road Medical
projects revenue for the full year 2024 to range from $194 million
to $198 million.
Conference CallSilk Road Medical will host a
conference call at 1:30 p.m. PT / 4:30 p.m. ET on Wednesday,
February 28, 2024, to discuss its fourth quarter and full year 2023
financial results. Those interested in listening to the conference
call should register online using this link. Participants are
encouraged to register more than 15 minutes before the start of the
call. A live and replay version of the webcast will be available at
https://investors.silkroadmed.com and will remain available for at
least 12 months.
About Silk Road MedicalSilk Road Medical, Inc.
(NASDAQ: SILK), is a medical device company located in Sunnyvale,
California and Plymouth, Minnesota, that is focused on reducing the
risk of stroke and its devastating impact. The Company has
pioneered a new approach for the treatment of carotid artery
disease called TransCarotid Artery Revascularization (TCAR). TCAR
is a clinically proven procedure combining surgical principles of
neuroprotection with minimally invasive endovascular techniques to
treat blockages in the carotid artery at risk of causing a stroke.
For more information on how Silk Road Medical is delivering
brighter patient outcomes through brighter clinical thinking, visit
www.silkroadmed.com and connect on X, LinkedIn and Facebook.
Forward-Looking StatementsStatements contained
in this press release that relate to future, not past, events are
forward-looking statements under the Private Securities Litigation
Reform Act of 1995, including Silk Road Medical’s financial
guidance and statements related to the future opportunity of its
business. Forward-looking statements are based on current
expectations of future events and often can be identified by words
such as “expect,” “should,” “project,” “anticipate,” “intend,”
“will,” “can,” “may,” “believe,” “could,” “continue,” “outlook,”
“guidance,” “future,” other words of similar meaning or the use of
future dates. Forward-looking statements by their nature address
matters that are, to different degrees, uncertain. Risks and
uncertainties may cause Silk Road Medical’s actual results to be
materially different than those expressed in or implied by Silk
Road Medical’s forward-looking statements. For Silk Road Medical,
such risks and uncertainties include, among others, future
operating results and financial performance; the Company’s success
in retaining and recruiting key personnel; the ability to continue
to grow the business and expand the use of TCAR; the ability to
obtain an adequate supply of materials and components from its
third-party suppliers; product development plans and the ability to
commercialize new products in a timely manner; the success of
current clinical trials; plans to conduct further clinical trials;
the ability to obtain additional indications or new regulatory
approvals or clearances for its products; market acceptance and use
of its products by physicians; the ability to grow and leverage its
commercialization infrastructure; the effect of increased
competition; the effect of economic conditions and COVID-19 or
similar pandemics on its business; government and third-party payer
coverage and reimbursement and the ability to obtain and maintain
intellectual property protection for its products. More detailed
information on these and other factors that could affect Silk Road
Medical’s actual results are described in its filings with the U.S.
Securities and Exchange Commission, including its most recent
Annual Report on Form 10-K filed with the Securities and Exchange
Commission today, February 28, 2024. Silk Road Medical undertakes
no obligation to update its forward-looking statements.
Use of Non-GAAP Financial MeasuresTo supplement
its financial statements prepared in accordance with U.S. generally
accepted accounting principles (GAAP), the Company uses adjusted
EBITDA, which is a non-GAAP financial measure, in this press
release. A reconciliation of non-GAAP adjusted EBITDA to GAAP net
loss, which is the most directly comparable GAAP financial measure,
is provided in the financial statement tables included in this
press release, and investors are encouraged to review the
reconciliation. Non-GAAP adjusted EBITDA is calculated by adding
back to net loss or excluding, as appropriate, interest income and
expense, provision for income taxes, and charges for depreciation
and amortization and is further adjusted by adding back in or
excluding, as appropriate, other income and expense and stock-based
compensation. The Company believes the presentation of adjusted
EBITDA provides useful information to investors as it provides
visibility to the Company’s underlying continuing operating
performance from period to period by excluding the impact of
certain items that are non-cash or non-recurring in nature or not
related to the Company’s core business operations. Adjusted EBITDA
is also frequently used by analysts, investors and other interested
parties to evaluate companies in the same industry. Management uses
adjusted EBITDA internally for evaluation of the performance of the
Company’s business, including the allocation of resources.
The Company’s definition of adjusted EBITDA may differ from
similarly titled measures used by others. Adjusted EBITDA should be
considered only as a supplement to, and not as a substitute for, or
superior to, net income or loss prepared in accordance with GAAP.
Because adjusted EBITDA excludes the effect of items that increase
or decrease the Company’s reported results of operations,
management strongly encourages investors to review, when they
become available, the Company’s financial statements and publicly
filed SEC reports in their entirety.
Investor Contact:Marissa BychGilmartin
Groupinvestors@silkroadmed.com
Media:Michael FanucchiSilk Road
Medicalmfanucchi@silkroadmed.com
SILK ROAD MEDICAL, INC. |
Statements of Operations Data |
(unaudited, in thousands, except share and per share
data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Year Ended |
|
December 31, |
|
December 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenue |
$ |
47,270 |
|
|
$ |
40,070 |
|
|
$ |
177,134 |
|
|
$ |
138,638 |
|
Cost of goods sold |
|
12,468 |
|
|
|
10,979 |
|
|
|
50,048 |
|
|
|
37,876 |
|
Gross profit |
|
34,802 |
|
|
|
29,091 |
|
|
|
127,086 |
|
|
|
100,762 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
10,064 |
|
|
|
9,200 |
|
|
|
41,324 |
|
|
|
36,449 |
|
Selling, general and administrative |
|
39,110 |
|
|
|
32,521 |
|
|
|
145,033 |
|
|
|
116,317 |
|
Total operating expenses |
|
49,174 |
|
|
|
41,721 |
|
|
|
186,357 |
|
|
|
152,766 |
|
Loss from operations |
|
(14,372 |
) |
|
|
(12,630 |
) |
|
|
(59,271 |
) |
|
|
(52,004 |
) |
Interest income |
|
2,618 |
|
|
|
1,776 |
|
|
|
9,957 |
|
|
|
2,527 |
|
Interest expense |
|
(1,734 |
) |
|
|
(1,732 |
) |
|
|
(6,871 |
) |
|
|
(5,098 |
) |
Loss on debt
extinguishment |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(245 |
) |
Other income (expense),
net |
|
477 |
|
|
|
(28 |
) |
|
|
442 |
|
|
|
(190 |
) |
Net loss |
|
(13,011 |
) |
|
|
(12,614 |
) |
|
|
(55,743 |
) |
|
|
(55,010 |
) |
Other comprehensive income
(loss): |
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on investments, net |
|
356 |
|
|
|
25 |
|
|
|
238 |
|
|
|
(166 |
) |
Other comprehensive income
(loss) |
|
356 |
|
|
|
25 |
|
|
|
238 |
|
|
|
(166 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
$ |
(12,655 |
) |
|
$ |
(12,589 |
) |
|
$ |
(55,505 |
) |
|
$ |
(55,176 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
$ |
(0.33 |
) |
|
$ |
(0.34 |
) |
|
$ |
(1.44 |
) |
|
$ |
(1.54 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares
used to compute net loss per share, basic and diluted |
|
39,048,656 |
|
|
|
37,609,019 |
|
|
|
38,804,343 |
|
|
|
35,775,672 |
|
SILK ROAD MEDICAL, INC. |
Balance Sheets Data |
(unaudited, in thousands) |
|
|
|
|
|
|
|
December 31, 2023 |
|
December 31, 2022 |
Assets |
|
|
|
|
|
Current assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
20,210 |
|
|
$ |
55,358 |
|
Short-term investments |
|
161,264 |
|
|
|
158,316 |
|
Accounts receivable, net |
|
23,573 |
|
|
|
18,007 |
|
Inventories |
|
29,876 |
|
|
|
19,293 |
|
Prepaid expenses and other current assets |
|
5,912 |
|
|
|
3,924 |
|
Total current assets |
|
240,835 |
|
|
|
254,898 |
|
Long-term investments |
|
9,456 |
|
|
|
— |
|
Property and equipment,
net |
|
8,114 |
|
|
|
9,372 |
|
Restricted cash |
|
— |
|
|
|
155 |
|
Other non-current assets |
|
6,904 |
|
|
|
5,260 |
|
Total assets |
$ |
265,309 |
|
|
$ |
269,685 |
|
Liabilities and
stockholders' equity |
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Accounts payable |
$ |
5,676 |
|
|
$ |
2,523 |
|
Accrued liabilities |
|
24,607 |
|
|
|
21,965 |
|
Total current liabilities |
|
30,283 |
|
|
|
24,488 |
|
Long-term debt |
|
75,626 |
|
|
|
74,596 |
|
Other liabilities |
|
8,249 |
|
|
|
6,726 |
|
Total liabilities |
|
114,158 |
|
|
|
105,810 |
|
Stockholders' equity |
|
|
|
|
|
Preferred stock, $0.001 par value |
|
— |
|
|
|
— |
|
Common stock, $0.001 par value |
|
39 |
|
|
|
38 |
|
Additional paid-in
capital |
|
550,495 |
|
|
|
507,715 |
|
Accumulated other
comprehensive income (loss) |
|
72 |
|
|
|
(166 |
) |
Accumulated deficit |
|
(399,455 |
) |
|
|
(343,712 |
) |
Total stockholders' equity |
|
151,151 |
|
|
|
163,875 |
|
Total liabilities and stockholders' equity |
$ |
265,309 |
|
|
$ |
269,685 |
|
SILK ROAD MEDICAL, INC. |
Reconciliation of GAAP Net Loss to Adjusted
EBITDA |
(unaudited, in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Year Ended |
|
December 31, |
|
December 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
GAAP Net Loss |
$ |
(13,011 |
) |
|
$ |
(12,614 |
) |
|
$ |
(55,743 |
) |
|
$ |
(55,010 |
) |
Non-GAAP Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Interest (income) expense, net |
|
(884 |
) |
|
|
(44 |
) |
|
|
(3,086 |
) |
|
|
2,571 |
|
Depreciation and amortization |
|
656 |
|
|
|
661 |
|
|
|
2,696 |
|
|
|
2,127 |
|
Other (income) expense, net |
|
(477 |
) |
|
|
28 |
|
|
|
(442 |
) |
|
|
190 |
|
Stock-based compensation expense |
|
9,609 |
|
|
|
7,546 |
|
|
|
38,893 |
|
|
|
25,023 |
|
Adjusted EBITDA |
$ |
(4,107 |
) |
|
$ |
(4,423 |
) |
|
$ |
(17,682 |
) |
|
$ |
(25,099 |
) |
Silk Road Medical (NASDAQ:SILK)
Gráfica de Acción Histórica
De Ago 2024 a Sep 2024
Silk Road Medical (NASDAQ:SILK)
Gráfica de Acción Histórica
De Sep 2023 a Sep 2024