Shockwave Medical, Inc. (Nasdaq: SWAV), a pioneer in the
development and commercialization of transformational technologies
for the treatment of cardiovascular disease, today reported
financial results for the three months ended June 30, 2023.
Recent Highlights
- Recognized revenue of $180.2 million for the second quarter of
2023, representing an increase of 49% from the same period in
2022
- As part of the Fiscal Year 2024 Medicare Hospital Inpatient
Prospective Payment System (IPPS) final rule, the Centers for
Medicare & Medicaid Services (CMS) created three new coronary
IVL-specific MS-DRGs, which will become effective October 1, 2023.
These new codes are associated with higher payments than the MS-DRG
payments for other Percutaneous Coronary Intervention (PCI)
procedures
- Announced the full commercial availability of the Shockwave C2+
Coronary Intravascular Lithotripsy (IVL) Catheter to treat severely
calcified coronary artery disease in select international
markets
- Initiated enrollment in EMPOWER CAD, the first prospective,
all-female study of percutaneous coronary intervention, seeking to
confirm the benefits of coronary IVL in female patients with
calcified lesions, a patient population that historically has
experienced less favorable clinical outcomes with traditional
therapies compared with male patients
- Closed the acquisition of Neovasc and commenced the integration
into Shockwave
“Our teams throughout the Shockwave organization continue to
execute at the highest level, enabling us to offer an expanding
range of products to meet the needs of our customers across the
globe,” said Doug Godshall, President and Chief Executive Officer
of Shockwave Medical. “The consistent growth across our business is
a testament to the need for our novel products and we look forward
to continuing to provide innovative solutions to improve outcomes
for patients suffering from cardiovascular diseases.”
Second Quarter 2023 Financial Results
Revenue for the second quarter ended June 30, 2023, was $180.2
million, a 49% increase from $120.7 million in the same period of
2022. The growth was primarily driven by an increase in the
purchase volume of our catheters in both the United
States and internationally.
Gross profit for the second quarter of 2023 was $155.7 million
compared to $104.0 million for the second quarter of 2022. Gross
margin percentage was 86% for the three months ended June 30,
2023, which was unchanged from the gross margin percentage for the
three months ended June 30, 2022.
Total operating expenses for the second quarter of 2023 were
$123.3 million, a 66% increase from $74.4 million in the second
quarter of 2022. The increase was primarily driven by sales force
expansion, higher headcount to support the growth of the business,
and acquisition-related expenses associated with the acquisition of
Neovasc.
Net income for the second quarter of 2023 was $28.9 million,
compared to net income of $25.6 million in the same period of 2022.
Basic and diluted net income per share for the period was $0.79 and
$0.76, respectively.
Cash, cash equivalents and short-term investments totaled $258.6
million as of June 30, 2023.
2023 Financial Guidance
Shockwave Medical projects revenue for the full year 2023 to
range from $725 million to $730 million, which represents 48% to
49% growth over the Company’s prior year revenue. This compares to
previous revenue guidance for the full year of 2023 of $700 million
to $720 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, August 7, 2023, to
discuss its second quarter 2023 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:
13737256. A live and archived webcast of the event will be
available at https://ir.shockwavemedical.com/.
About Shockwave Medical, Inc.
Shockwave Medical is a leader in the development and
commercialization of innovative products that are transforming the
treatment of cardiovascular disease. Its first-of-its-kind
Intravascular Lithotripsy (IVL) technology has transformed the
treatment of atherosclerotic cardiovascular disease by safely using
sonic pressure waves to disrupt challenging calcified plaque,
resulting in significantly improved patient outcomes. Shockwave has
also recently acquired the Neovasc Reducer, which is under clinical
investigation in the United States and is CE Marked in the European
Union and the United Kingdom. By redistributing blood flow within
the heart, the Reducer is designed to provide relief to the
millions of patients worldwide suffering from refractory angina.
Learn more at www.shockwavemedical.com and www.neovasc.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.
Forward-looking statements in this press release include, but are
not limited to, statements regarding our anticipated future
operating results and financial position, including for the full
year ending December 31, 2023, our business strategy and plans, our
objectives for future operations and financial performance and
other matters. 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
macroeconomic conditions, including inflation, rising interest
rates, the federal budget, instability in the global banking
system, and volatile market conditions, geopolitical factors,
including the ongoing conflict between Russia and Ukraine and
responses thereto, and supply chain disruptions, on our operations,
financial results, liquidity, capital resources, expenses, supply
chain, manufacturing, research and development activities, clinical
trials, and employees; our ability to successfully execute our
business and growth strategies; our ability to develop,
manufacture, obtain and maintain regulatory approvals for, and
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; the success of any acquisitions that we make; 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 the
sections titled “Risk Factors” in our most recent Annual Report on
Form 10-K and subsequently filed Quarterly Reports on Form 10-Q,
and in our 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) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,2023 |
|
December 31,2022 |
|
|
|
(Unaudited) |
|
|
|
ASSETS |
|
|
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
141,458 |
|
|
$ |
156,586 |
|
|
Short-term investments |
|
|
117,131 |
|
|
|
147,907 |
|
|
Accounts receivable, net |
|
|
96,562 |
|
|
|
71,366 |
|
|
Inventory |
|
|
92,093 |
|
|
|
75,112 |
|
|
Prepaid expenses and other current assets |
|
|
9,118 |
|
|
|
8,292 |
|
|
Total current assets |
|
|
456,362 |
|
|
|
459,263 |
|
|
Operating lease right-of-use
assets |
|
|
31,117 |
|
|
|
32,365 |
|
|
Property and equipment, net |
|
|
59,803 |
|
|
|
48,152 |
|
|
Equity method investment |
|
|
2,543 |
|
|
|
3,512 |
|
|
Intangible assets, net |
|
|
94,692 |
|
|
|
— |
|
|
Goodwill |
|
|
39,789 |
|
|
|
— |
|
|
Deferred tax assets |
|
|
94,699 |
|
|
|
97,568 |
|
|
Other assets |
|
|
7,599 |
|
|
|
5,229 |
|
|
TOTAL ASSETS |
|
$ |
786,604 |
|
|
$ |
646,089 |
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
|
Accounts payable |
|
$ |
12,869 |
|
|
$ |
6,721 |
|
|
Accrued liabilities |
|
|
65,769 |
|
|
|
55,375 |
|
|
Lease liability, current portion |
|
|
1,582 |
|
|
|
1,278 |
|
|
Total current liabilities |
|
|
80,220 |
|
|
|
63,374 |
|
|
Lease liability, noncurrent
portion |
|
|
33,205 |
|
|
|
34,928 |
|
|
Debt, noncurrent portion |
|
|
24,266 |
|
|
|
24,198 |
|
|
Related party contract liability,
noncurrent portion |
|
|
12,273 |
|
|
|
12,273 |
|
|
Deferred tax liabilities |
|
|
10,421 |
|
|
|
— |
|
|
Other liabilities |
|
|
9,307 |
|
|
|
— |
|
|
TOTAL LIABILITIES |
|
|
169,692 |
|
|
|
134,773 |
|
|
STOCKHOLDERS’ EQUITY: |
|
|
|
|
|
Preferred stock |
|
|
— |
|
|
|
— |
|
|
Common stock |
|
|
37 |
|
|
|
36 |
|
|
Additional paid-in capital |
|
|
586,092 |
|
|
|
548,960 |
|
|
Accumulated other comprehensive
loss |
|
|
(391) |
|
|
|
(867) |
|
|
Retained earnings (accumulated
deficit) |
|
|
31,174 |
|
|
|
(36,813) |
|
|
TOTAL STOCKHOLDERS’ EQUITY |
|
|
616,912 |
|
|
|
511,316 |
|
|
TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
$ |
786,604 |
|
|
$ |
646,089 |
|
|
SHOCKWAVE MEDICAL, INC. |
Statement of Operations Data |
(Unaudited) |
(in thousands, except share and per share
data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Revenue: |
|
|
|
|
|
|
|
|
Product revenue |
|
$ |
180,165 |
|
|
$ |
120,746 |
|
|
$ |
341,231 |
|
|
$ |
214,377 |
|
Cost of revenue: |
|
|
|
|
|
|
|
|
Cost of product revenue |
|
|
24,493 |
|
|
|
16,730 |
|
|
|
45,559 |
|
|
|
29,620 |
|
Gross profit |
|
|
155,672 |
|
|
|
104,016 |
|
|
|
295,672 |
|
|
|
184,757 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
36,829 |
|
|
|
20,760 |
|
|
|
63,800 |
|
|
|
37,779 |
|
Sales and marketing |
|
|
56,738 |
|
|
|
40,515 |
|
|
|
110,749 |
|
|
|
76,476 |
|
General and administrative |
|
|
29,731 |
|
|
|
13,165 |
|
|
|
48,935 |
|
|
|
25,554 |
|
Total operating expenses |
|
|
123,298 |
|
|
|
74,440 |
|
|
|
223,484 |
|
|
|
139,809 |
|
Income from operations |
|
|
32,374 |
|
|
|
29,576 |
|
|
|
72,188 |
|
|
|
44,948 |
|
Loss from equity method
investment |
|
|
(146) |
|
|
|
(1,464) |
|
|
|
(969) |
|
|
|
(1,511) |
|
Interest expense |
|
|
(810) |
|
|
|
(304) |
|
|
|
(1,446) |
|
|
|
(601) |
|
Other income (expense), net |
|
|
1,586 |
|
|
|
(1,473) |
|
|
|
3,968 |
|
|
|
(1,783) |
|
Net income before taxes |
|
|
33,004 |
|
|
|
26,335 |
|
|
|
73,741 |
|
|
|
41,053 |
|
Income tax provision |
|
|
4,142 |
|
|
|
774 |
|
|
|
5,754 |
|
|
|
971 |
|
Net income |
|
$ |
28,862 |
|
|
$ |
25,561 |
|
|
$ |
67,987 |
|
|
$ |
40,082 |
|
Net income per share, basic |
|
$ |
0.79 |
|
|
$ |
0.71 |
|
|
$ |
1.86 |
|
|
$ |
1.12 |
|
Net income per share,
diluted |
|
$ |
0.76 |
|
|
$ |
0.68 |
|
|
$ |
1.78 |
|
|
$ |
1.06 |
|
Shares used in computing net
income per share, basic |
|
|
36,663,327 |
|
|
|
35,825,947 |
|
|
|
36,545,948 |
|
|
|
35,707,301 |
|
Shares used in computing net
income per share, diluted |
|
|
38,226,153 |
|
|
|
37,690,094 |
|
|
|
38,139,948 |
|
|
|
37,690,320 |
|
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