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 September 30, 2023.
Recent Highlights
- Recognized revenue of $186.0 million for the third quarter of
2023, representing an increase of 42% from the same period in
2022
- Announced, priced and closed an offering for convertible debt,
with net proceeds of $634.4 million
- Introduced the Shockwave C2+ Coronary Intravascular Lithotripsy
(IVL) catheter at the 35th Transcatheter Cardiovascular
Therapeutics (TCT) annual scientific symposium of the
Cardiovascular Research Foundation
- Granted a Category I Current Procedural Terminology (CPT®)
add-on code for procedures involving coronary Intravascular
Lithotripsy (IVL) by the U.S. Centers for Medicare & Medicaid
Services (CMS) as part of the Calendar Year 2024 Physician Fee
Schedule (PFS) final rule, which will provide physicians with a
20-30% increase in remuneration (RVUs and/or fees) for the
additional work associated with performing coronary IVL
“We had a strong quarter with solid performance from our
businesses and significant progress operationally across the
globe,” said Doug Godshall, President and Chief Executive Officer
of Shockwave Medical. “We were excited to share more about some of
the exciting happenings at Shockwave during our recent Investor
Innovation Day, and we look forward to bringing a continuous
pipeline of novel products to our customers to improve outcomes for
patients suffering from cardiovascular disease.”
Third Quarter 2023 Financial Results
Revenue for the third quarter ended September 30, 2023, was
$186.0 million, a 42% increase from $131.3 million in the same
period of 2022. The growth was primarily driven by an increase in
the purchase volume of our products in both the United
States and internationally.
Gross profit for the third quarter of 2023 was $161.5 million
compared to $113.5 million for the third quarter of 2022. Gross
margin percentage was 87% for the three months ended
September 30, 2023, compared to 86% for the three months ended
September 30, 2022.
Total operating expenses for the third quarter of 2023 were
$117.9 million, a 54% increase from $76.7 million in the third
quarter of 2022. The increase was primarily driven by sales force
expansion and higher headcount to support the growth of the
business.
Net income for the third quarter of 2023 was $35.0 million,
which was consistent with net income in the same period of 2022.
Basic and diluted net income per share for the third quarter of
2023 was $0.95 and $0.92 respectively.
Adjusted EBITDA improved by approximately 31% to $65.0 million,
in the third quarter of 2023, compared to adjusted EBITDA of $49.8
million in the third quarter of 2022. Adjusted EBITDA is a non-GAAP
measure.
Cash, cash equivalents and short-term investments totaled $917.3
million as of September 30, 2023, which is inclusive of net
proceeds of $634.4 million from our convertible debt offering in
August of 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.
Conference Call
Shockwave Medical will host a conference call at 1:30 p.m.
Pacific Time / 4:30 p.m. Eastern Time on Monday, November 6, 2023,
to discuss its third 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:
13737257. 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
Medical 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
global business, political, and macroeconomic conditions, including
inflation, rising interest rates, uncertainty with respect to the
federal budget, instability in the global banking system, volatile
market conditions, supply chain disruptions, cybersecurity events
and global events, including regional conflicts around the world,
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.
Use of Non-GAAP Financial Measures
This press release contains supplemental financial information
determined by methods other than in accordance with accounting
principles generally accepted in the United States (GAAP),
including references to adjusted EBITDA, a non-GAAP financial
measure that excludes from net income the effects of income tax
provision, other income (expense), interest expense, (loss) income
from equity method investment, depreciation and amortization, and
stock-based compensation. We believe the presentation of adjusted
EBITDA is useful as it provides visibility to our underlying
continuing operating performance by excluding the impact of certain
items that are non-cash in nature or not related to our core
business operations.
Our definition of adjusted EBITDA may differ from similarly
titled measures used by others. Adjusted EBITDA should be
considered supplemental to, and not a substitute for, financial
information prepared in accordance with GAAP. Because adjusted
EBITDA excludes the effect of items that increase or decrease our
reported results of operations, management strongly encourages
investors to review, when they become available, our consolidated
financial statements and publicly filed reports in their entirety.
A reconciliation of adjusted EBITDA to net income has been provided
in the financial statement tables included in this press release,
and investors are encouraged to review the reconciliation.
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 30,2023 |
|
December 31,2022 |
|
|
(Unaudited) |
|
|
ASSETS |
|
|
|
|
CURRENT
ASSETS: |
|
|
|
|
Cash and cash equivalents |
|
$ |
498,108 |
|
|
$ |
156,586 |
|
Short-term investments |
|
|
419,225 |
|
|
|
147,907 |
|
Accounts receivable, net |
|
|
98,819 |
|
|
|
71,366 |
|
Inventory |
|
|
97,180 |
|
|
|
75,112 |
|
Prepaid expenses and other current assets |
|
|
15,210 |
|
|
|
8,292 |
|
Total current assets |
|
|
1,128,542 |
|
|
|
459,263 |
|
Operating lease right-of-use assets |
|
|
30,360 |
|
|
|
32,365 |
|
Property
and equipment, net |
|
|
62,017 |
|
|
|
48,152 |
|
Equity
method investment |
|
|
1,810 |
|
|
|
3,512 |
|
Intangible assets, net |
|
|
93,775 |
|
|
|
— |
|
Goodwill |
|
|
39,789 |
|
|
|
— |
|
Deferred
tax assets |
|
|
109,432 |
|
|
|
97,568 |
|
Other
assets |
|
|
8,234 |
|
|
|
5,229 |
|
TOTAL
ASSETS |
|
$ |
1,473,959 |
|
|
$ |
646,089 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
CURRENT
LIABILITIES: |
|
|
|
|
Accounts payable |
|
$ |
6,870 |
|
|
$ |
6,721 |
|
Accrued liabilities |
|
|
69,764 |
|
|
|
55,375 |
|
Lease liability, current portion |
|
|
1,569 |
|
|
|
1,278 |
|
Total current liabilities |
|
|
78,203 |
|
|
|
63,374 |
|
Lease
liability, noncurrent portion |
|
|
32,358 |
|
|
|
34,928 |
|
Convertible debt, noncurrent portion |
|
|
730,926 |
|
|
|
— |
|
Debt,
noncurrent portion |
|
|
— |
|
|
|
24,198 |
|
Related
party contract liability, noncurrent portion |
|
|
12,273 |
|
|
|
12,273 |
|
Deferred
tax liabilities |
|
|
9,647 |
|
|
|
— |
|
Other
liabilities |
|
|
9,307 |
|
|
|
— |
|
TOTAL
LIABILITIES |
|
|
872,714 |
|
|
|
134,773 |
|
STOCKHOLDERS’ EQUITY: |
|
|
|
|
Preferred stock |
|
|
— |
|
|
|
— |
|
Common
stock |
|
|
37 |
|
|
|
36 |
|
Additional paid-in capital |
|
|
535,197 |
|
|
|
548,960 |
|
Accumulated other comprehensive loss |
|
|
(149 |
) |
|
|
(867 |
) |
Retained
earnings (accumulated deficit) |
|
|
66,160 |
|
|
|
(36,813 |
) |
TOTAL
STOCKHOLDERS’ EQUITY |
|
|
601,245 |
|
|
|
511,316 |
|
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
$ |
1,473,959 |
|
|
$ |
646,089 |
|
|
|
|
|
|
|
|
|
|
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, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenue: |
|
|
|
|
|
|
|
|
Product revenue |
|
$ |
186,020 |
|
|
$ |
131,330 |
|
|
$ |
527,251 |
|
|
$ |
345,707 |
|
Cost of revenue: |
|
|
|
|
|
|
|
|
Cost of product revenue |
|
|
24,513 |
|
|
|
17,874 |
|
|
|
70,072 |
|
|
|
47,494 |
|
Gross profit |
|
|
161,507 |
|
|
|
113,456 |
|
|
|
457,179 |
|
|
|
298,213 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
39,526 |
|
|
|
20,177 |
|
|
|
103,326 |
|
|
|
57,956 |
|
Sales and marketing |
|
|
56,907 |
|
|
|
42,082 |
|
|
|
167,656 |
|
|
|
118,558 |
|
General and administrative |
|
|
21,451 |
|
|
|
14,434 |
|
|
|
70,386 |
|
|
|
39,988 |
|
Total operating expenses |
|
|
117,884 |
|
|
|
76,693 |
|
|
|
341,368 |
|
|
|
216,502 |
|
Income from operations |
|
|
43,623 |
|
|
|
36,763 |
|
|
|
115,811 |
|
|
|
81,711 |
|
(Loss) income from equity
method investment |
|
|
(733 |
) |
|
|
97 |
|
|
|
(1,702 |
) |
|
|
(1,414 |
) |
Interest expense |
|
|
(2,509 |
) |
|
|
(316 |
) |
|
|
(3,955 |
) |
|
|
(917 |
) |
Other income (expense),
net |
|
|
4,699 |
|
|
|
(1,423 |
) |
|
|
8,667 |
|
|
|
(3,206 |
) |
Net income before taxes |
|
|
45,080 |
|
|
|
35,121 |
|
|
|
118,821 |
|
|
|
76,174 |
|
Income tax provision |
|
|
10,094 |
|
|
|
118 |
|
|
|
15,848 |
|
|
|
1,089 |
|
Net income |
|
$ |
34,986 |
|
|
$ |
35,003 |
|
|
$ |
102,973 |
|
|
$ |
75,085 |
|
Net income per share,
basic |
|
$ |
0.95 |
|
|
$ |
0.97 |
|
|
$ |
2.81 |
|
|
$ |
2.10 |
|
Net income per share,
diluted |
|
$ |
0.92 |
|
|
$ |
0.92 |
|
|
$ |
2.70 |
|
|
$ |
1.99 |
|
Shares used in computing net
income per share, basic |
|
|
36,797,072 |
|
|
|
36,003,931 |
|
|
|
36,630,575 |
|
|
|
35,807,264 |
|
Shares used in computing net
income per share, diluted |
|
|
38,196,780 |
|
|
|
37,948,049 |
|
|
|
38,184,299 |
|
|
|
37,813,107 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SHOCKWAVE MEDICAL, INC. |
Reconciliation of GAAP Net Income to Adjusted
EBITDA |
(Unaudited) |
(in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
2022 |
GAAP Net Income |
|
$ |
34,986 |
|
|
$ |
35,003 |
|
|
$ |
102,973 |
|
|
$ |
75,085 |
Non-GAAP Adjustments |
|
|
|
|
|
|
|
|
Income tax provision |
|
|
10,094 |
|
|
|
118 |
|
|
|
15,848 |
|
|
|
1,089 |
Other (income) expense |
|
|
(4,699 |
) |
|
|
1,423 |
|
|
|
(8,667 |
) |
|
|
3,206 |
Interest expense |
|
|
2,509 |
|
|
|
316 |
|
|
|
3,955 |
|
|
|
917 |
Loss (income) from equity method investment |
|
|
733 |
|
|
|
(97 |
) |
|
|
1,702 |
|
|
|
1,414 |
Depreciation and amortization |
|
|
3,009 |
|
|
|
1,258 |
|
|
|
7,283 |
|
|
|
3,318 |
Stock-based compensation expense |
|
|
18,410 |
|
|
|
11,732 |
|
|
|
51,423 |
|
|
|
32,247 |
Adjusted EBITDA |
|
$ |
65,042 |
|
|
$ |
49,753 |
|
|
$ |
174,517 |
|
|
$ |
117,276 |
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