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 and full year ended December
31, 2023.
Recent Highlights
- Recognized revenue of $203.0 million for the fourth quarter of
2023 and $730.2 million for the full year 2023, representing
increases of 41% and 49%, respectively, from the same periods in
2022
- Initiated the full U.S. commercial launch of the Shockwave C2+
Coronary Intravascular Lithotripsy (IVL) catheter
- Granted new physician and hospital reimbursement for coronary
IVL in the United States. Three newly created MS-DRGs specific to
coronary IVL for hospital payment in the inpatient setting became
effective October 1, 2023. A new Category I CPT add-on code that
provides physicians with remuneration for the additional work
associated with performing coronary IVL became effective January 1,
2024
“The team ended 2023 with solid performances across our business
and geographies,” said Doug Godshall, President and Chief Executive
Officer of Shockwave Medical. “Our record revenue is a testament to
the continued clinical need for our innovative products and our
ability to grow the Shockwave organization to meet those needs as
we pursue our mission to improve outcomes for patients suffering
from cardiovascular disease.”
Fourth Quarter 2023 Financial Results
Revenue for the fourth quarter of 2023 was $203.0 million, an
increase of $59.0 million, or 41%, compared to the corresponding
prior year period. Revenue growth was primarily driven by increased
adoption of Shockwave products in both the United States and
internationally.
Gross profit for the fourth quarter of 2023 was $177.7 million
compared to $126.5 million for the corresponding prior year period.
Gross margin for the fourth quarter of 2023 was 88%, consistent
with 88% for the corresponding prior year period.
Operating expenses for the fourth quarter of 2023 were $134.4
million, compared to $84.1 million for the corresponding prior year
period, representing a 60% increase, primarily driven by increases
in headcount to support the growth of the business and Reducer
spend resulting from the Neovasc acquisition that closed in
2023.
Net income was $44.3 million in the fourth quarter of 2023, as
compared to a net income of $140.9 million in the corresponding
prior year period. In the fourth quarter of 2022, we released our
valuation allowance, which resulted in a tax benefit of $99.0
million in that quarter. Basic net income per share was $1.20 in
the fourth quarter of 2023. Diluted net income per share was $1.16
in the fourth quarter of 2023.
Adjusted EBITDA was $68.2 million in the fourth quarter of 2023,
a 20% increase compared to adjusted EBITDA of $56.6
million in the fourth quarter of 2022. Adjusted EBITDA is a
non-GAAP measure. For additional information regarding non-GAAP
financial measures, see “Use of Non-GAAP Financial Measures” and
“Reconciliation of GAAP Net Income to Adjusted EBITDA” below.
Full Year 2023 Financial Results
Revenue for the full year 2023 was $730.2 million, an increase
of $240.5 million, or 49%, compared to the full year 2022. The
growth was primarily driven by an increase in the purchase volume
of our products in the United States and increased adoption of our
products internationally.
Gross profit for the full year 2023 was $634.8 million compared
to $424.7 million for the full year 2022. Gross margin for the full
year 2023 was 87%, consistent with 87% for the full year 2022.
Operating expenses were $475.7 million for the full year 2023,
compared to $300.6 million for the full year 2022, an increase of
58% primarily driven by increases in headcount to support the
growth of the business and Reducer spend resulting from the Neovasc
acquisition that closed in 2023.
Net income was $147.3 million for the full year 2023, compared
to $216.0 million for the full year 2022. Net income in 2022
included a $99.0 million tax benefit from the release of our
valuation allowance in that year. Basic net income per share was
$4.01 for the full year 2023. Diluted net income per share was
$3.85 for the full year 2023.
Adjusted EBITDA was $242.7 million for the full year 2023, a 40%
increase compared to adjusted EBITDA of $173.9
million for the full year 2022. Adjusted EBITDA is a non-GAAP
measure.
Cash, cash equivalents and short-term investments totaled $990.6
million as of December 31, 2023.
2024 Financial Guidance
Shockwave Medical projects revenue for the full year 2024 to
range from $910 million to $930 million, which represents 25% to
27% growth over the full year 2023 revenue.
Conference Call
Shockwave Medical will host a conference call at 1:30 p.m.
Pacific Time / 4:30 p.m. Eastern Time on Thursday, February 15,
2024, to discuss its fourth quarter and full year 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: 13742096. 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 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.
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, 2024, 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 and the related potential for government shutdowns,
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
(benefit) provision, other income, interest expense, loss from
equity method investment, depreciation and amortization, and
stock-based compensation expense. 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) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,2023 |
|
December 31,2022 |
|
|
|
(Unaudited) |
|
|
|
ASSETS |
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
328,422 |
|
$ |
156,586 |
|
|
Short-term investments |
|
|
662,132 |
|
|
147,907 |
|
|
Accounts receivable, net |
|
|
114,552 |
|
|
71,366 |
|
|
Inventory |
|
|
107,587 |
|
|
75,112 |
|
|
Prepaid expenses and other current assets |
|
|
12,567 |
|
|
8,292 |
|
|
Total current assets |
|
|
1,225,260 |
|
|
459,263 |
|
|
Operating lease right-of-use
assets |
|
|
29,707 |
|
|
32,365 |
|
|
Property and equipment,
net |
|
|
68,923 |
|
|
48,152 |
|
|
Equity method investment |
|
|
1,643 |
|
|
3,512 |
|
|
Intangible assets, net |
|
|
92,857 |
|
|
— |
|
|
Goodwill |
|
|
39,568 |
|
|
— |
|
|
Deferred tax assets |
|
|
99,169 |
|
|
97,568 |
|
|
Other assets |
|
|
9,436 |
|
|
5,229 |
|
|
TOTAL ASSETS |
|
$ |
1,566,563 |
|
$ |
646,089 |
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
|
Accounts payable |
|
$ |
8,868 |
|
$ |
6,721 |
|
|
Accrued liabilities |
|
|
91,696 |
|
|
55,375 |
|
|
Lease liability, current portion |
|
|
3,641 |
|
|
1,278 |
|
|
Total current liabilities |
|
|
104,205 |
|
|
63,374 |
|
|
Lease liability, noncurrent
portion |
|
|
35,103 |
|
|
34,928 |
|
|
Convertible debt, noncurrent
portion |
|
|
731,863 |
|
|
— |
|
|
Debt, noncurrent portion |
|
|
— |
|
|
24,198 |
|
|
Related party contract
liability, noncurrent portion |
|
|
12,273 |
|
|
12,273 |
|
|
Deferred tax liabilities |
|
|
3,609 |
|
|
— |
|
|
Long-term income tax
liability |
|
|
1,526 |
|
|
— |
|
|
Other liabilities |
|
|
9,307 |
|
|
— |
|
|
TOTAL LIABILITIES |
|
|
897,886 |
|
|
134,773 |
|
|
STOCKHOLDERS’ EQUITY: |
|
|
|
|
|
Preferred stock |
|
|
— |
|
|
— |
|
|
Common stock |
|
|
37 |
|
|
36 |
|
|
Additional paid-in
capital |
|
|
557,882 |
|
|
548,960 |
|
|
Accumulated other
comprehensive income (loss) |
|
|
293 |
|
|
(867 |
) |
|
Retained earnings (accumulated
deficit) |
|
|
110,465 |
|
|
(36,813 |
) |
|
TOTAL STOCKHOLDERS’
EQUITY |
|
|
668,677 |
|
|
511,316 |
|
|
TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
$ |
1,566,563 |
|
$ |
646,089 |
|
|
|
SHOCKWAVE MEDICAL, INC. |
Statement of Operations Data |
(Unaudited) |
(in thousands, except share and per share
data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Year Ended |
|
|
December 31, |
|
December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenue: |
|
|
|
|
|
|
|
|
Product revenue |
|
$ |
202,979 |
|
|
$ |
144,026 |
|
|
$ |
730,230 |
|
|
$ |
489,733 |
|
Cost of revenue: |
|
|
|
|
|
|
|
|
Cost of product revenue |
|
|
25,316 |
|
|
|
17,502 |
|
|
|
95,388 |
|
|
|
64,996 |
|
Gross profit |
|
|
177,663 |
|
|
|
126,524 |
|
|
|
634,842 |
|
|
|
424,737 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
42,321 |
|
|
|
23,723 |
|
|
|
145,647 |
|
|
|
81,679 |
|
Sales and marketing |
|
|
67,181 |
|
|
|
43,437 |
|
|
|
234,837 |
|
|
|
161,995 |
|
General and administrative |
|
|
24,879 |
|
|
|
16,941 |
|
|
|
95,265 |
|
|
|
56,929 |
|
Total operating expenses |
|
|
134,381 |
|
|
|
84,101 |
|
|
|
475,749 |
|
|
|
300,603 |
|
Income from operations |
|
|
43,282 |
|
|
|
42,423 |
|
|
|
159,093 |
|
|
|
124,134 |
|
Loss from equity method
investment |
|
|
(167 |
) |
|
|
(1,061 |
) |
|
|
(1,869 |
) |
|
|
(2,475 |
) |
Interest expense |
|
|
(2,950 |
) |
|
|
(969 |
) |
|
|
(6,905 |
) |
|
|
(1,886 |
) |
Other income, net |
|
|
15,295 |
|
|
|
4,261 |
|
|
|
23,962 |
|
|
|
1,055 |
|
Net income before taxes |
|
|
55,460 |
|
|
|
44,654 |
|
|
|
174,281 |
|
|
|
120,828 |
|
Income tax (benefit)
provision |
|
|
11,155 |
|
|
|
(96,257 |
) |
|
|
27,003 |
|
|
|
(95,168 |
) |
Net income |
|
$ |
44,305 |
|
|
$ |
140,911 |
|
|
$ |
147,278 |
|
|
$ |
215,996 |
|
Net income per share,
basic |
|
$ |
1.20 |
|
|
$ |
3.89 |
|
|
$ |
4.01 |
|
|
$ |
6.02 |
|
Net income per share,
diluted |
|
$ |
1.16 |
|
|
$ |
3.71 |
|
|
$ |
3.85 |
|
|
$ |
5.70 |
|
Shares used in computing net
income per share, basic |
|
|
36,930,055 |
|
|
|
36,178,112 |
|
|
|
36,706,060 |
|
|
|
35,900,738 |
|
Shares used in computing net
income per share, diluted |
|
|
38,158,637 |
|
|
|
37,994,698 |
|
|
|
38,206,269 |
|
|
|
37,881,590 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SHOCKWAVE MEDICAL, INC. |
Reconciliation of GAAP Net Income to Adjusted
EBITDA |
(Unaudited) |
(in thousands) |
|
|
Three Months Ended |
|
Year Ended |
|
|
December 31, |
|
December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
GAAP Net Income |
|
$ |
44,305 |
|
|
$ |
140,911 |
|
|
$ |
147,278 |
|
|
$ |
215,996 |
|
Non-GAAP Adjustments |
|
|
|
|
|
|
|
|
Income tax (benefit) provision |
|
|
11,155 |
|
|
|
(96,257 |
) |
|
|
27,003 |
|
|
|
(95,168 |
) |
Other income |
|
|
(15,295 |
) |
|
|
(4,261 |
) |
|
|
(23,962 |
) |
|
|
(1,055 |
) |
Interest expense |
|
|
2,950 |
|
|
|
969 |
|
|
|
6,905 |
|
|
|
1,886 |
|
Loss from equity method investment |
|
|
167 |
|
|
|
1,061 |
|
|
|
1,869 |
|
|
|
2,475 |
|
Depreciation and amortization |
|
|
3,075 |
|
|
|
1,538 |
|
|
|
10,358 |
|
|
|
4,856 |
|
Stock-based compensation expense |
|
|
21,811 |
|
|
|
12,643 |
|
|
|
73,234 |
|
|
|
44,890 |
|
Adjusted EBITDA |
|
$ |
68,168 |
|
|
$ |
56,604 |
|
|
$ |
242,685 |
|
|
$ |
173,880 |
|
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