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,
2022.
Recent Highlights
- Recognized revenue of $93.6 million for the first quarter of
2022, representing an increase of 194% from the same period in
2021
- Received regulatory approval for the Shockwave C2 Coronary IVL
Catheter in Japan
- Announced the global commercial availability and launch of the
Shockwave M5+ peripheral IVL catheter after receiving both CE Mark
and U.S. Food and Drug Administration (FDA) clearance
“Our growth this quarter was driven by strong execution from our
teams across the globe, despite the myriad geopolitical, health and
economic challenges that continue to face us all.” said Doug
Godshall, President and Chief Executive Officer of Shockwave
Medical. “The exceptional progress that the Shockwave team has made
this quarter continues to demonstrate what an important solution
IVL has become for patients who suffer from calcified arterial
disease. We look forward to continuing to partner with our
customers to help them enhance outcomes for their
patients.”
First Quarter 2022 Financial Results
Revenue for the first quarter ended March 31, 2022 was $93.6
million, a 194% increase from $31.9 million in the same period of
2021. The growth was primarily driven by the launch of the coronary
product, Shockwave C2, in the U.S. in February 2021, continued
recovery from the pandemic impact and increased adoption of
Shockwave products.
Gross profit for the first quarter of 2022 was $80.7 million
compared to $24.0 million for the first quarter of 2021. Gross
margin for the first quarter of 2022 was 86%, as compared to 75% in
the first quarter of 2021. The increase in gross margin was
primarily driven by product mix along with continued improvement in
manufacturing productivity and process efficiencies.
Total operating expenses for the first quarter of 2022 were
$65.4 million, a 58% increase from $41.5 million in the first
quarter of 2021. The increase was primarily driven by sales force
expansion in the U.S. and higher headcount to support the growth of
the business.
Net income for the first quarter of 2022 was $14.5 million,
compared to a net loss of $23.6 million in the same period of 2021.
Basic and diluted net income per share for the period was $0.41 and
$0.39, respectively.
Cash, cash equivalents and short-term investments totaled $201.1
million as of March 31, 2022.
2022 Financial GuidanceShockwave Medical
projects revenue for the full year 2022 to range from $435 million
to $455 million, which represents 83% to 92% growth over the
Company’s prior year revenue. This compares to previous revenue
guidance of $405 million to $425 million.
Conference Call
Shockwave Medical will host a conference call at 1:30 p.m.
Pacific Time / 4:30 p.m. Eastern Time on Monday, May 9, 2022, to
discuss its first quarter 2022 financial results. The call may be
accessed through an operator by dialing (866) 795-9106 for domestic
callers or (470) 495-9173 for international callers, using
conference ID: 7258221. A live and archived webcast of the event
will be available at https://ir.shockwavemedical.com/.
About Shockwave Medical, Inc.
Shockwave Medical is focused on developing and commercializing
products intended to transform the way calcified cardiovascular
disease is treated. Shockwave Medical aims to establish a new
standard of care for the interventional treatment of
atherosclerotic cardiovascular disease through differentiated and
proprietary local delivery of sonic pressure waves for the
treatment of calcified plaque, which Shockwave Medical refers 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 our
expectations, projections, beliefs, and prospects, which are
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. In some cases, you can
identify these statements by forward-looking words such as “may,”
“might,” “will,” “should,” “expects,” “plans,” “anticipates,”
“believes,” “estimates,” “predicts,” “potential” or “continue,” and
similar expressions, and the negative of these terms. You are
cautioned not to place undue reliance on these forward-looking
statements. Forward-looking statements are only predictions based
on our current expectations, estimates, and assumptions, valid only
as of the date they are made, and subject to risks and
uncertainties, some of which we are not currently aware.
Important factors that could cause our actual results and
financial condition to differ materially from those indicated in
the forward-looking statements include, among others: the impact of
the COVID-19 pandemic on our operations, financial results, and
liquidity and capital resources, including the impact on our sales,
expenses, supply chain, manufacturing, research and development
activities, clinical trials, and employees; our ability to develop,
manufacture, obtain and maintain regulatory approvals for, market
and sell, our products; our expected future growth, including the
size and growth potential of the markets for our products; our
ability to obtain coverage and reimbursement for procedures
performed using our products; our ability to scale our
organizational culture; the impact of the development, regulatory
approval, efficacy and commercialization of competing products; the
loss of key scientific or management personnel; our ability to
develop and maintain our corporate infrastructure, including our
internal controls; our financial performance and capital
requirements; and 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 factors, as well as others, are discussed
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. Except to the extent
required by law, we do not undertake to update any of these
forward-looking statements after the date hereof to conform these
statements to actual results or revised expectations.
Media Contact: Scott
Shadiow+1.317.432.9210sshadiow@shockwavemedical.com
Investor Contact:Debbie Kasterdkaster@shockwavemedical.com
SHOCKWAVE MEDICAL, INC. |
Balance Sheet Data |
(in thousands) |
|
|
|
|
|
|
|
March 31,2022(Unaudited) |
|
December 31,2021 |
|
|
|
|
|
ASSETS |
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
Cash and cash equivalents |
|
$ |
66,252 |
|
|
$ |
89,209 |
|
Short-term investments |
|
|
134,875 |
|
|
|
111,772 |
|
Accounts receivable, net |
|
|
47,842 |
|
|
|
37,435 |
|
Inventory |
|
|
53,369 |
|
|
|
42,978 |
|
Prepaid expenses and other current assets |
|
|
7,572 |
|
|
|
4,508 |
|
Total current assets |
|
|
309,910 |
|
|
|
285,902 |
|
Operating lease right-of-use
assets |
|
|
26,729 |
|
|
|
27,496 |
|
Property and equipment, net |
|
|
27,886 |
|
|
|
24,361 |
|
Equity method investment |
|
|
5,940 |
|
|
|
5,987 |
|
Other assets |
|
|
2,055 |
|
|
|
1,936 |
|
TOTAL ASSETS |
|
$ |
372,520 |
|
|
$ |
345,682 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
Accounts payable |
|
$ |
8,467 |
|
|
$ |
3,520 |
|
Term notes, current portion |
|
|
8,250 |
|
|
|
5,500 |
|
Accrued liabilities |
|
|
33,019 |
|
|
|
40,870 |
|
Lease liability, current portion |
|
|
1,294 |
|
|
|
1,738 |
|
Total current liabilities |
|
|
51,030 |
|
|
|
51,628 |
|
Lease liability, noncurrent |
|
|
32,361 |
|
|
|
28,321 |
|
Term notes, noncurrent
portion |
|
|
9,033 |
|
|
|
11,630 |
|
Related party contract liability,
noncurrent portion |
|
|
12,273 |
|
|
|
12,273 |
|
TOTAL LIABILITIES |
|
|
104,697 |
|
|
|
103,852 |
|
STOCKHOLDERS’ EQUITY: |
|
|
|
|
Preferred stock |
|
|
— |
|
|
|
— |
|
Common stock |
|
|
36 |
|
|
|
35 |
|
Additional paid-in capital |
|
|
507,092 |
|
|
|
494,806 |
|
Accumulated other comprehensive
loss |
|
|
(1,017 |
) |
|
|
(202 |
) |
Accumulated deficit |
|
|
(238,288 |
) |
|
|
(252,809 |
) |
TOTAL STOCKHOLDERS’ EQUITY |
|
|
267,823 |
|
|
|
241,830 |
|
TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
$ |
372,520 |
|
|
$ |
345,682 |
|
SHOCKWAVE MEDICAL, INC. |
Statement of Operations Data |
(Unaudited) |
(in thousands, except share and per share
data) |
|
|
|
|
|
|
|
Three Months EndedMarch 31, |
|
|
|
2022 |
|
|
|
2021 |
|
Revenue: |
|
|
|
|
Product revenue |
|
$ |
93,631 |
|
|
$ |
31,900 |
|
Cost of revenue: |
|
|
|
|
Cost of product revenue |
|
|
12,890 |
|
|
|
7,892 |
|
Gross profit |
|
|
80,741 |
|
|
|
24,008 |
|
Operating expenses: |
|
|
|
|
Research and development |
|
|
17,019 |
|
|
|
10,277 |
|
Sales and marketing |
|
|
35,961 |
|
|
|
23,992 |
|
General and administrative |
|
|
12,389 |
|
|
|
7,226 |
|
Total operating expenses |
|
|
65,369 |
|
|
|
41,495 |
|
Income (Loss) from
operations |
|
|
15,372 |
|
|
|
(17,487 |
) |
Share in net loss of equity
method investment |
|
|
(47 |
) |
|
|
(5,523 |
) |
Interest expense |
|
|
(297 |
) |
|
|
(312 |
) |
Other expense, net |
|
|
(310 |
) |
|
|
(235 |
) |
Net income (loss) before
taxes |
|
|
14,718 |
|
|
|
(23,557 |
) |
Income tax provision |
|
|
197 |
|
|
|
44 |
|
Net income (loss) |
|
$ |
14,521 |
|
|
$ |
(23,601 |
) |
Net income (loss) per share,
basic |
|
$ |
0.41 |
|
|
$ |
(0.68 |
) |
Net income (loss) per share,
diluted |
|
$ |
0.39 |
|
|
$ |
(0.68 |
) |
Shares used in computing net
income (loss) per share, basic |
|
|
35,587,337 |
|
|
|
34,797,400 |
|
Shares used in computing net
income (loss) per share, diluted |
|
|
37,623,477 |
|
|
|
34,797,400 |
|
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