Generated record quarterly revenue of $86
million, an increase of 62% y/y
Reported fiscal year 2022 revenue of $274
million, an increase of 52% y/y
Reiterated fiscal year 2023 revenue guidance of
$342 million, an increase of 25% y/y
Axonics, Inc. (Nasdaq: AXNX), a global medical technology
company that is developing and commercializing novel products for
the treatment of bladder and bowel dysfunction, today reported
financial results for the three months and fiscal year ended
December 31, 2022.
“This quarter’s record results reflect the growing demand for
our best-in-class incontinence products,” said Raymond W. Cohen,
chief executive officer of Axonics. “Our U.S. commercial team is
continuing to take advantage of increased patient awareness and the
overwhelmingly positive physician response to the Axonics F15™
recharge-free sacral neuromodulation system while leveraging cross
selling opportunities with Bulkamid®. Our unique hydrogel generated
another record revenue quarter and during 2022, Bulkamid was used
to treat over 50,000 women with stress urinary incontinence.”
Cohen continued, “In addition to strong commercial execution, we
are encouraged by the measurable operating leverage in our business
which produced adjusted EBITDA of $10 million in the quarter. We
continue to make progress on several key initiatives, including our
direct-to-consumer advertising campaign, expansion of our in-house
manufacturing capabilities that has benefited gross margin, and the
recent FDA approval of the Axonics R20™, our fourth-generation
rechargeable sacral neuromodulation system. We remain confident
that our commitment to innovation, quality and providing physicians
and patients strong clinical support will continue to drive market
expansion and advance Axonics on its path to incontinence market
leadership.”
Fourth Quarter 2022 Financial Results
- Net revenue was $85.9 million in fourth quarter 2022, an
increase of 62% compared to the prior year period.
- Sacral neuromodulation revenue was $70.3 million, of which
$69.1 million was generated in the U.S. and the remainder in
international markets.
- Bulkamid revenue was $15.6 million, of which $12.3 million was
generated in the U.S. and the remainder in international
markets.
- Gross margin was 73.3% in fourth quarter 2022 compared to 66.6%
in the prior year period.
- Operating expenses were $66.6 million in fourth quarter 2022
and included a $2.1 million non-cash charge for the change in fair
value of contingent consideration related to the Bulkamid
acquisition. Operating expenses were $53.1 million in the prior
year period.
- Excluding acquisition-related charges, adjusted operating
expenses were $64.5 million in fourth quarter 2022 and $51.6
million in the prior year period.
- Adjusted EBITDA was $10.1 million in fourth quarter 2022
compared to an adjusted EBITDA loss of $6.7 million in the prior
year period.
- Net income was $0.7 million in fourth quarter 2022 compared to
a net loss of $15.2 million in the prior year period.
- Net income in fourth quarter 2022 benefited from $3.8 million
of interest and other income, net.
- Cash, cash equivalents and short-term investments were $357
million as of December 31, 2022.
Fiscal Year 2022 Financial Results
- Net revenue was $273.7 million in fiscal year 2022, an increase
of 52% compared to the prior year.
- SNM revenue was $222.0 million, of which $216.9 million was
generated in the U.S. and the remainder in international
markets.
- Bulkamid revenue was $51.7 million, of which $40.2 million was
generated in the U.S. and the remainder in international
markets.
- Gross margin was 72.2% in fiscal year 2022 compared to 64.2% in
the prior year.
- Operating expenses were $262.6 million in fiscal year 2022 and
included $22.6 million of non-cash charges for the change in fair
value of contingent consideration related to the Bulkamid
acquisition. Operating expenses were $187.5 million in the prior
year.
- Excluding acquisition-related charges, adjusted operating
expenses were $240.1 million in fiscal year 2022 and $180.4 million
in the prior year.
- Adjusted EBITDA was $1.6 million in fiscal year 2022 compared
to an adjusted EBITDA loss of $30.4 million in the prior year.
- Net loss was $59.7 million in fiscal year 2022 compared to net
loss of $80.1 million in the prior year.
Fiscal Year 2023 Revenue Guidance
Axonics is reiterating its previously announced fiscal year 2023
revenue guidance of $342 million, which is based on sacral
neuromodulation and Bulkamid revenue each growing 25% compared to
fiscal year 2022.
- Sacral neuromodulation revenue of $277.5 million.
- Bulkamid revenue of $64.5 million.
Webcast and Conference Call
Axonics will host a conference call today at 4:30 p.m. Eastern
Time to discuss financial results and recent business developments.
Interested parties may join the conference call by telephone by
registering at the following link: Axonics 4Q22 registration. After
registering, a confirmation email will be sent that includes the
dial-in number and unique access code required to join the
conference call by telephone.
For those not planning to ask a question on the conference call,
the company recommends joining the live webcast, which can be
accessed by visiting the following link: Axonics 4Q22 webcast. A
replay of the webcast will be archived in the Events section of the
Axonics investor relations website.
About Axonics®
Axonics is a global medical technology company that is
developing and commercializing novel products for adults with
bladder and bowel dysfunction. Axonics recently ranked No. 1 on the
2022 Financial Times ranking of the 500 fastest growing companies
in the Americas and No. 4 on the 2022 Deloitte Technology Fast 500™
following its No. 1 ranking in 2021.
Axonics sacral neuromodulation systems provide adults with
overactive bladder and/or fecal incontinence with long-lived, easy
to use, safe, clinically effective therapy. In addition, the
company’s best-in-class urethral bulking hydrogel, Bulkamid®,
provides safe and durable symptom relief to women with stress
urinary incontinence. In the U.S., moderate to severe urinary
incontinence affects an estimated 28 million women and fecal
incontinence affects an estimated 19 million adults. Axonics’
clinically proven products are offered at hundreds of medical
centers across the U.S. and abroad. Reimbursement coverage is well
established in the U.S. and is a covered service in most European
countries. For more information, visit www.axonics.com.
Forward-Looking Statements
Statements made in this press release that relate to future
plans, events, prospects or performance are forward-looking
statements as defined under the Private Securities Litigation
Reform Act of 1995. Words such as “plans,” “expects,” “believes,”
“anticipates,” “designs,” and similar words are intended to
identify forward-looking statements. While these forward-looking
statements are based on the current expectations and beliefs of
management, such forward-looking statements are subject to a number
of risks, uncertainties, assumptions and other factors that could
cause actual results to differ materially from the expectations
expressed in this press release, including the risks and
uncertainties disclosed in Axonics filings with the Securities and
Exchange Commission, all of which are available online at
www.sec.gov. Readers are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date
hereof. Except as required by law, Axonics undertakes no obligation
to update or revise any forward-looking statements to reflect new
information, changed circumstances or unanticipated events.
Use of Non-GAAP Financial Measures
To supplement Axonics’ consolidated financial statements
prepared in accordance with generally accepted accounting
principles (GAAP), Axonics provides certain non-GAAP financial
measures in this release as supplemental financial metrics.
Adjusted EBITDA is calculated as net income (loss) before other
income/expense (including interest), income tax expense (benefit),
depreciation and amortization expense, stock-based compensation
expense, acquisition-related costs, loss on disposal of property
and equipment, and expense related to impairment of intangible
assets. Management believes that in order to properly understand
short-term and long-term financial trends, investors may want to
consider the impact of these excluded items in addition to GAAP
measures. The excluded items vary in frequency and/or impact on our
results of operations and management believes that the excluded
items are typically not reflective of our ongoing core business
operations and financial condition. Further, management uses
adjusted EBITDA for both strategic and annual operating planning. A
reconciliation of adjusted EBITDA reported in this release to the
most comparable GAAP measure for the respective periods appears in
the table captioned “Reconciliation of GAAP Net Income (Loss) to
Adjusted EBITDA” later in this release.
The non-GAAP financial measures used by Axonics may not be the
same or calculated in the same manner as those used and calculated
by other companies. Non-GAAP financial measures have limitations as
analytical tools and should not be considered in isolation or as a
substitute for Axonics’ financial results prepared and reported in
accordance with GAAP. We urge investors to review the
reconciliation of these non-GAAP financial measures to the
comparable GAAP financial measures included in this press release,
and not to rely on any single financial measure to evaluate our
business.
Axonics, Inc.
Consolidated Balance
Sheets
(in thousands, except share
and per share data)
December 31,
2022
2021
(unaudited)
ASSETS
Current assets
Cash and cash equivalents
$
238,846
$
220,878
Short-term investments
118,365
—
Accounts receivable, net of allowance for
credit losses of $321 and $355 at December 31, 2022 and 2021,
respectively
44,817
29,044
Inventory, net
55,765
64,946
Prepaid expenses and other current
assets
7,282
6,449
Total current assets
465,075
321,317
Property and equipment, net
6,798
6,915
Intangible assets, net
86,253
106,469
Other assets
6,813
7,734
Goodwill
94,414
105,510
Total assets
$
659,353
$
547,945
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities
Accounts payable
$
9,070
$
7,654
Accrued liabilities
6,520
5,435
Accrued compensation and benefits
15,495
12,413
Operating lease liability, current
portion
1,562
1,366
Other current liabilities
32,600
—
Total current liabilities
65,247
26,868
Operating lease liability, net of current
portion
7,555
9,052
Deferred tax liabilities, net
16,412
19,217
Other long-term liabilities
—
10,370
Total liabilities
89,214
65,507
Stockholders’ equity
Preferred stock, par value $0.0001 per
share; 10,000,000 shares authorized, no shares issued and
outstanding at December 31, 2022 and 2021
—
—
Common stock, par value $0.0001 per share,
75,000,000 and 50,000,000 shares authorized at December 31, 2022
and 2021, respectively; 49,546,727 and 46,330,167 shares issued and
outstanding at December 31, 2022 and 2021, respectively
5
5
Additional paid-in capital
969,545
803,559
Accumulated deficit
(374,264
)
(314,566
)
Accumulated other comprehensive loss
(25,147
)
(6,560
)
Total stockholders’ equity
570,139
482,438
Total liabilities and stockholders’
equity
$
659,353
$
547,945
Axonics, Inc.
Consolidated Statements of
Comprehensive Income (Loss)
(in thousands, except share
and per share data)
Three Months Ended December
31,
Years Ended December
31,
2022
2021
2022
2021
(unaudited)
(unaudited)
(unaudited)
Net revenue
$
85,918
$
53,135
$
273,702
$
180,290
Cost of goods sold
22,951
17,744
76,037
64,572
Gross profit
62,967
35,391
197,665
115,718
Operating expenses
Research and development
8,103
10,182
34,410
37,297
General and administrative
10,264
7,937
40,238
30,041
Sales and marketing
43,824
31,338
156,019
105,789
Amortization of intangible assets
2,271
2,147
9,383
7,241
Acquisition-related costs
2,114
1,467
22,561
7,158
Total operating expenses
66,576
53,071
262,611
187,526
Loss from operations
(3,609
)
(17,680
)
(64,946
)
(71,808
)
Other income (expense)
Interest and other income
3,229
16
5,133
40
Loss on disposal of property and
equipment
(69
)
(91
)
(69
)
(91
)
Interest and other expense
592
102
(2,434
)
(7,426
)
Other income (expense), net
3,752
27
2,630
(7,477
)
Income (loss) before income tax (benefit)
expense
143
(17,653
)
(62,316
)
(79,285
)
Income tax (benefit) expense
(522
)
(2,487
)
(2,618
)
782
Net income (loss)
665
(15,166
)
(59,698
)
(80,067
)
Foreign currency translation
adjustment
11,038
352
(18,587
)
(6,129
)
Comprehensive income (loss)
$
11,703
$
(14,814
)
$
(78,285
)
$
(86,196
)
Net income (loss) per share, basic
$
0.01
$
(0.29
)
$
(1.28
)
$
(1.86
)
Weighted-average shares used to compute
basic net income (loss) per share
48,166,003
38,971,859
46,684,478
43,072,298
Net income (loss) per share, diluted
$
0.01
$
(0.29
)
$
(1.28
)
$
(1.86
)
Weighted-average shares used to compute
basic net income (loss) per share
50,460,039
38,971,859
46,684,478
43,072,298
Axonics, Inc.
Net Revenue by Product and
Region
(in thousands)
Three Months Ended December
31,
Years Ended December
31,
2022
2021
2022
2021
(unaudited)
(unaudited)
(unaudited)
SNM
United States
$
69,068
$
43,702
$
216,861
$
153,837
International
1,236
722
5,130
3,753
SNM total
$
70,304
$
44,424
$
221,991
$
157,590
Bulkamid
United States
$
12,341
$
5,790
$
40,178
$
12,660
International
3,273
2,921
11,533
10,040
Bulkamid total
$
15,614
$
8,711
$
51,711
$
22,700
Total net revenue
$
85,918
$
53,135
$
273,702
$
180,290
Axonics, Inc.
Reconciliation of GAAP Net
Income (Loss) to Adjusted EBITDA
(unaudited)
(in thousands)
Three Months Ended December
31,
Years Ended December
31,
2022
2021
2022
2021
GAAP Net income (loss)
$
665
$
(15,166
)
$
(59,698
)
$
(80,067
)
Non-GAAP Adjustments:
Interest and other income
(3,229
)
(16
)
(5,133
)
(40
)
Interest and other expense
(592
)
(102
)
2,434
7,426
Income tax (benefit) expense
(522
)
(2,487
)
(2,618
)
782
Depreciation and amortization expense
2,880
2,643
11,721
9,126
Stock-based compensation expense
8,757
6,844
32,018
25,164
Acquisition-related costs
2,114
1,467
22,561
7,158
Loss on disposal of property and
equipment
69
91
69
91
Impairment expense
—
—
287
—
Adjusted EBITDA
$
10,142
$
(6,726
)
$
1,641
$
(30,360
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230301005930/en/
Axonics contact: Neil Bhalodkar 949-336-5293
IR@axonics.com
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