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 September 30,
2022.
Recent Highlights
- Recognized revenue of $131.3 million for the third quarter of
2022, representing an increase of 102% from the same period in
2021
- Received FDA Clearance for the Shockwave IVL System with the
Shockwave L6 Peripheral IVL Catheter
- Received CE marking for the Shockwave C2+ coronary catheter in
Europe
- Granted reimbursement for the Shockwave C2 Coronary IVL
Catheter by the Japanese Ministry of Health, Labour and Welfare
(MHLW) in Japan
“Our third quarter achievements were encouraging across the
entire Shockwave organization. Sales of all products, both in the
U.S. and international markets, outperformed expectations, and
operationally our accomplishments continue to be the backbone of
our success,” said Doug Godshall, President and Chief Executive
Officer of Shockwave Medical. “These results were particularly
impressive in light of the many ongoing macro issues we have all
seen across the globe. Despite these challenges, our team and our
customers have been able to adapt and remain focused on using our
IVL technology to treat patients suffering from calcified vascular
disease.”
Third Quarter 2022 Financial Results
Revenue for the third quarter ended September 30, 2022, was
$131.3 million, a 102% increase from $65.2 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 third quarter of 2022 was $113.5 million
compared to $54.2 million for the third quarter of 2021. Gross
margin for the third quarter of 2022 was 86%, as compared to 83% in
the third 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 third quarter of 2022 were
$76.7 million, a 49% increase from $51.4 million in the third
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 third quarter of 2022 was $35.0 million,
compared to net income of $1.9 million in the same period of 2021.
Basic and diluted net income per share for the third quarter of
2022 was $0.97 and $0.92, respectively.
Cash, cash equivalents and short-term investments totaled $250.7
million as of September 30, 2022.
2022 Financial GuidanceShockwave Medical
projects revenue for the full year 2022 to range from $483 million
to $488 million, which represents 104% to 106% growth over the
Company’s prior year revenue. This compares to previous revenue
guidance of $465 million to $475 million.
Conference CallShockwave Medical will host a
conference call at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time
on Monday, November 7, 2022, to discuss its third quarter 2022
financial results. The call may be accessed by dialing 877-704-4453
for domestic callers or 201-389-0920 for international callers,
using conference ID:13733213. 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) |
|
|
|
|
|
|
|
September 30,2022 |
|
December 31,2021 |
|
|
(Unaudited) |
|
|
ASSETS |
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
Cash and cash equivalents |
|
$ |
127,779 |
|
|
$ |
89,209 |
|
Short-term investments |
|
|
122,888 |
|
|
|
111,772 |
|
Accounts receivable, net |
|
|
64,224 |
|
|
|
37,435 |
|
Inventory |
|
|
68,974 |
|
|
|
42,978 |
|
Prepaid expenses and other current assets |
|
|
11,393 |
|
|
|
4,508 |
|
Total current assets |
|
|
395,258 |
|
|
|
285,902 |
|
Operating lease right-of-use
assets |
|
|
33,107 |
|
|
|
27,496 |
|
Property and equipment, net |
|
|
39,265 |
|
|
|
24,361 |
|
Equity method investment |
|
|
4,573 |
|
|
|
5,987 |
|
Other assets |
|
|
3,606 |
|
|
|
1,936 |
|
TOTAL ASSETS |
|
$ |
475,809 |
|
|
$ |
345,682 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
Accounts payable |
|
$ |
3,469 |
|
|
$ |
3,520 |
|
Term notes, current portion |
|
|
— |
|
|
|
5,500 |
|
Accrued liabilities |
|
|
49,492 |
|
|
|
40,870 |
|
Lease liability, current portion |
|
|
1,260 |
|
|
|
1,738 |
|
Total current liabilities |
|
|
54,221 |
|
|
|
51,628 |
|
Lease liability, noncurrent |
|
|
38,532 |
|
|
|
28,321 |
|
Term notes, noncurrent
portion |
|
|
14,853 |
|
|
|
11,630 |
|
Related party contract liability,
noncurrent portion |
|
|
12,273 |
|
|
|
12,273 |
|
TOTAL LIABILITIES |
|
|
119,879 |
|
|
|
103,852 |
|
STOCKHOLDERS’ EQUITY: |
|
|
|
|
Preferred stock |
|
|
— |
|
|
|
— |
|
Common stock |
|
|
36 |
|
|
|
35 |
|
Additional paid-in capital |
|
|
535,230 |
|
|
|
494,806 |
|
Accumulated other comprehensive
loss |
|
|
(1,612 |
) |
|
|
(202 |
) |
Accumulated deficit |
|
|
(177,724 |
) |
|
|
(252,809 |
) |
TOTAL STOCKHOLDERS’ EQUITY |
|
|
355,930 |
|
|
|
241,830 |
|
TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
$ |
475,809 |
|
|
$ |
345,682 |
|
|
|
|
|
|
|
SHOCKWAVE MEDICAL, INC. |
Statement of Operations Data |
(Unaudited) |
(in thousands, except share and per share
data) |
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
Product revenue |
|
$ |
131,330 |
|
|
$ |
65,155 |
|
|
$ |
345,707 |
|
|
$ |
152,963 |
|
|
Cost of revenue: |
|
|
|
|
|
|
|
|
|
Cost of product revenue |
|
|
17,874 |
|
|
|
10,949 |
|
|
|
47,494 |
|
|
|
28,775 |
|
|
Gross profit |
|
|
113,456 |
|
|
|
54,206 |
|
|
|
298,213 |
|
|
|
124,188 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
|
20,177 |
|
|
|
13,735 |
|
|
|
57,956 |
|
|
|
35,827 |
|
|
Sales and marketing |
|
|
42,082 |
|
|
|
28,393 |
|
|
|
118,558 |
|
|
|
78,098 |
|
|
General and administrative |
|
|
14,434 |
|
|
|
9,265 |
|
|
|
39,988 |
|
|
|
25,117 |
|
|
Total operating expenses |
|
|
76,693 |
|
|
|
51,393 |
|
|
|
216,502 |
|
|
|
139,042 |
|
|
Income (loss) from
operations |
|
|
36,763 |
|
|
|
2,813 |
|
|
|
81,711 |
|
|
|
(14,854 |
) |
|
Income (loss) from equity method
investment |
|
|
97 |
|
|
|
(342 |
) |
|
|
(1,414 |
) |
|
|
(5,865 |
) |
|
Interest expense |
|
|
(316 |
) |
|
|
(165 |
) |
|
|
(917 |
) |
|
|
(795 |
) |
|
Other expense, net |
|
|
(1,423 |
) |
|
|
(280 |
) |
|
|
(3,206 |
) |
|
|
(369 |
) |
|
Net income (loss) before
taxes |
|
|
35,121 |
|
|
|
2,026 |
|
|
|
76,174 |
|
|
|
(21,883 |
) |
|
Income tax provision |
|
|
118 |
|
|
|
78 |
|
|
|
1,089 |
|
|
|
195 |
|
|
Net income (loss) |
|
$ |
35,003 |
|
|
$ |
1,948 |
|
|
$ |
75,085 |
|
|
$ |
(22,078 |
) |
|
Net income (loss) per share,
basic |
|
$ |
0.97 |
|
|
$ |
0.06 |
|
|
$ |
2.10 |
|
|
$ |
(0.63 |
) |
|
Net income (loss) per share,
diluted |
|
$ |
0.92 |
|
|
$ |
0.05 |
|
|
$ |
1.99 |
|
|
$ |
(0.63 |
) |
|
Shares used in computing net
income (loss) per share, basic |
|
|
36,003,931 |
|
|
|
35,207,276 |
|
|
|
35,807,264 |
|
|
|
35,013,072 |
|
|
Shares used in computing net
income (loss) per share, diluted |
|
|
37,948,049 |
|
|
|
37,567,176 |
|
|
|
37,813,107 |
|
|
|
35,013,072 |
|
|
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