Shockwave Medical, Inc. (Nasdaq: SWAV), a pioneer in the
development and commercialization of Intravascular Lithotripsy
(IVL) to treat complex calcified cardiovascular disease, today
reported financial results for the three months ended March 31,
2020.
Recent Highlights
- Recognized revenue of $15.2 million for the first quarter of
2020, representing an increase of 109% over the first quarter of
2019
- Completed enrollment in CAD III study of IVL for coronary use
in the U.S.
- Completed enrollment in CAD IV pivotal study of IVL for
coronary use in Japan
- Extended geographic reach and now commercial in 46
countries
- Expanded US field team from 61 to 78 members
“We are very pleased with our first
quarter results, particularly given the COVID-19 pandemic that is
so profoundly impacting the world. Our results reflect the
continued growth and penetration of our IVL products and the hard
work and dedication of our teams across the globe as we work to
continue to help our customers and patients in any way we can,”
said Doug Godshall, President and Chief Executive Officer of
Shockwave Medical. “The foundation of Shockwave remains strong and
I want to thank each employee and business partner for the
resiliency and dedication they have shown during this unprecedented
time. Our hearts go out to those who have lost their lives to the
COVID-19 pandemic and I want to express our gratitude to the
healthcare workers – many of whom are friends and customers of
Shockwave - who are on the front line fighting this pandemic.”
First Quarter 2020 Financial Results
Revenue for the first quarter of 2020 was $15.2 million, an
increase of $7.9 million, or 109%, compared to the first quarter of
2019. The growth was primarily driven by continued sales force
expansion in the U.S. and increased penetration in both U.S. and
international markets.
Gross profit for the first quarter of 2020 was $9.5 million
compared to $4.2 million for the first quarter of 2019. The gross
margin percentage for the first quarter of 2020 increased to 63%
compared to 58% in the first quarter of 2019, driven primarily by
continued improvements in production processes to drive
efficiencies and greater absorption of fixed costs from increased
production.
Operating expenses were $28.5 million for the first quarter of
2020 compared to $16.4 million in the corresponding prior year
period, an increase of 74%, primarily driven by sales force
expansion and clinical costs from the CAD III and CAD IV
studies.
Net loss was $18.8 million in the first quarter of 2020, as
compared to $12.8 million in the corresponding period of the prior
year. Net loss per share was $0.59 in the first quarter of
2020.
Cash, cash equivalents and short-term investments totaled $170.4
million as of March 31, 2020.
2020 Financial GuidanceShockwave Medical
withdrew its previously announced annual guidance for 2020 on April
6, 2020. The COVID-19 pandemic reduced IVL catheter sales toward
the end of the first quarter of 2020 and is continuing to adversely
impact sales in the second quarter of 2020. The pandemic could also
significantly impact the financial health of our customers which
could pressure hospital spending and impact pricing. As a result of
these factors as well as the uncertain scope and duration of the
COVID-19 pandemic, and uncertain timing of global recovery, we
cannot, at this time, reliably estimate the future impact on IVL
catheter sales, and in turn, our operations and financial
results.
Conference CallShockwave Medical will host a
teleconference at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time
on Tuesday, May 12, 2020 to discuss its first quarter. The
teleconference will be webcasted live and available in listen-only
mode on the company’s investor relations website at
https://ir.shockwavemedical.com/. An archived webcast of the event
will be available following the teleconference.
About Shockwave Medical, Inc. Shockwave Medical
is focused on developing and commercializing products intended to
transform the way calcified cardiovascular disease is treated. The
company aims to establish a new standard of care for medical device
treatment of atherosclerotic cardiovascular disease through their
differentiated and proprietary local delivery of sonic pressure
waves for the treatment of calcified plaque, which they refer to as
Intravascular Lithotripsy (IVL). IVL is a minimally invasive,
easy-to-use and safe way to significantly improve patient outcomes.
To view an animation of the IVL procedure and for more information,
visit www.shockwavemedical.com.
Forward-Looking Statements This press release
contains statements relating to Shockwave’s expectations,
projections, beliefs, and prospects (including statements regarding
Shockwave’s product development outlook), which are
“forward-looking statements” within the meaning of the federal
securities laws and by their nature are uncertain. Words such as
“believe,” “may,” “will,” “estimate,” “continue,” “anticipate,”
“intend,” “expect,” “plans,” and similar expressions are intended
to identify forward-looking statements. Such forward-looking
statements are not guarantees of future performance, and you are
cautioned not to place undue reliance on these forward-looking
statements.
Forward-looking statements include, but are not limited to
statements about: the impact of the COVID-19 pandemic on our
operations, financial results, and liquidity and capital resources,
including on our sales, expenses, supply chain, manufacturing,
research and development activities, clinical trials and employees;
our ability to design, develop, manufacture and market innovative
products to treat patients with challenging medical conditions,
particularly in peripheral artery disease, coronary artery disease
and aortic stenosis; our expected future growth, including growth
in international sales; the size and growth potential of the
markets for our products, and our ability to serve those markets;
the rate and degree of market acceptance of our products; coverage
and reimbursement for procedures performed using our products; the
performance of third parties in connection with the development of
our products, including third-party suppliers; regulatory
developments in the United States and foreign countries; our
ability to obtain and maintain regulatory approval or clearance of
our products on expected timelines; our plans to research, develop
and commercialize our products and any other approved or cleared
product; our ability to scale our organizational culture of
cooperative product development and commercial execution; the
development, regulatory approval, efficacy and commercialization of
competing products; the loss of key scientific or management
personnel; our expectations regarding the period during which we
qualify as an emerging growth company under the JOBS Act; our
ability to develop and maintain our corporate infrastructure,
including our internal controls; our financial performance and
capital requirements; and our expectations regarding our ability to
obtain and maintain intellectual property protection for our
products, as well as our ability to operate our business without
infringing the intellectual property rights of others.
These forward-looking statements are only predictions based on
our current expectations and projections about future events. There
are important factors that could cause our actual results, level of
activity, performance or achievements to differ materially from the
results, level of activity, performance or achievements expressed
or implied by the forward-looking statements. These factors, as
well as others, are discussed in greater detail in our filings with
the Securities and Exchange Commission (SEC), including in Part I,
Item IA - Risk Factors in our most recent Annual Report on Form
10-K filed with the SEC, and in our other periodic and other
reports filed with the SEC. There may be additional risks of which
we are not presently aware or that we currently believe are
immaterial which could have an adverse impact on our business. Any
forward-looking statements are based on our current expectations,
estimates and assumptions regarding future events and are
applicable only as of the dates of such statements. We make no
commitment to revise or update any forward-looking statements in
order to reflect events or circumstances that may change.
Media Contact: Scott Shadiow
+1.317.432.9210sshadiow@shockwavemedical.com
Investor Contact:Debbie Kaster, Gilmartin
Groupinvestors@shockwavemedical.com
SHOCKWAVE MEDICAL, INC. |
Balance Sheet Data |
(in thousands) |
|
|
March 31, 2020 |
|
December 31, 2019 |
|
|
|
|
|
ASSETS |
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
Cash and cash equivalents |
|
$ |
123,111 |
|
|
$ |
139,045 |
|
Short-term investments |
|
|
47,278 |
|
|
|
56,304 |
|
Accounts receivable, net |
|
|
7,811 |
|
|
|
7,377 |
|
Inventory |
|
|
15,921 |
|
|
|
12,074 |
|
Prepaid expenses and other current assets |
|
|
3,485 |
|
|
|
1,897 |
|
Total current assets |
|
|
197,606 |
|
|
|
216,697 |
|
Operating lease right-of-use
assets |
|
|
8,495 |
|
|
|
8,825 |
|
Property and equipment, net |
|
|
13,084 |
|
|
|
4,910 |
|
Other assets |
|
|
1,553 |
|
|
|
1,506 |
|
TOTAL ASSETS |
|
$ |
220,738 |
|
|
$ |
231,938 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
Accounts payable |
|
$ |
2,150 |
|
|
$ |
2,790 |
|
Term notes, current portion |
|
|
— |
|
|
|
6,667 |
|
Accrued liabilities |
|
|
15,826 |
|
|
|
13,777 |
|
Lease liability, current portion |
|
|
787 |
|
|
|
774 |
|
Total current liabilities |
|
|
18,763 |
|
|
|
24,008 |
|
Lease liability, noncurrent |
|
|
8,077 |
|
|
|
8,125 |
|
Term notes, noncurrent
portion |
|
|
16,126 |
|
|
|
7,152 |
|
TOTAL LIABILITIES |
|
|
42,966 |
|
|
|
39,285 |
|
STOCKHOLDERS’ EQUITY: |
|
|
|
|
Preferred stock |
|
|
— |
|
|
|
— |
|
Common stock |
|
|
32 |
|
|
|
31 |
|
Additional paid-in capital |
|
|
374,386 |
|
|
|
370,561 |
|
Accumulated other comprehensive
loss |
|
|
103 |
|
|
|
35 |
|
Accumulated deficit |
|
|
(196,749 |
) |
|
|
(177,974 |
) |
TOTAL STOCKHOLDERS’ EQUITY |
|
|
177,772 |
|
|
|
192,653 |
|
TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
$ |
220,738 |
|
|
$ |
231,938 |
|
|
SHOCKWAVE MEDICAL, INC. |
Statement of Operations Data |
(Unaudited) |
(in thousands, except share and per share
data) |
|
|
Three Months Ended March 31, |
|
|
|
2020 |
|
|
|
2019 |
|
Revenue: |
|
|
|
|
Product revenue |
|
$ |
15,197 |
|
|
$ |
7,269 |
|
Cost of revenue: |
|
|
|
|
Cost of product revenue |
|
|
5,651 |
|
|
|
3,072 |
|
Gross profit |
|
|
9,546 |
|
|
|
4,197 |
|
Operating expenses: |
|
|
|
|
Research and development |
|
|
11,890 |
|
|
|
7,484 |
|
Sales and marketing |
|
|
10,411 |
|
|
|
5,871 |
|
General and administrative |
|
|
6,224 |
|
|
|
3,001 |
|
Total operating expenses |
|
|
28,525 |
|
|
|
16,356 |
|
Loss from operations |
|
|
(18,979 |
) |
|
|
(12,159 |
) |
Interest expense |
|
|
(277 |
) |
|
|
(245 |
) |
Change in fair value of warrant
liability |
|
|
— |
|
|
|
(609 |
) |
Other income, net |
|
|
504 |
|
|
|
221 |
|
Net loss before taxes |
|
|
(18,752 |
) |
|
|
(12,792 |
) |
Income tax provision |
|
|
23 |
|
|
|
7 |
|
Net loss |
|
$ |
(18,775 |
) |
|
$ |
(12,799 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.59 |
) |
|
$ |
(1.37 |
) |
Shares used in computing net loss
per share, basic and diluted |
|
|
31,644,041 |
|
|
|
9,364,755 |
|
Shockwave Medical (NASDAQ:SWAV)
Historical Stock Chart
From Mar 2024 to Apr 2024
Shockwave Medical (NASDAQ:SWAV)
Historical Stock Chart
From Apr 2023 to Apr 2024