Generated quarterly revenue of $93.1 million,
an increase of 32% year over year
Fiscal year 2023 revenue guidance increased to
$362 million
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 ended September 30,
2023.
“Our commercial team continues to execute at a high level,
generating over 30% revenue growth in the third quarter,” said
Raymond W. Cohen, chief executive officer. “Our growth was driven
by higher utilization and share of wallet at existing customers and
the onboarding of new accounts. Based on the strong results
generated in the third quarter, we are raising our fiscal year 2023
revenue guidance to $362 million, representing growth of 32% year
over year.”
Mr. Cohen continued, “In the third quarter, the company also
generated adjusted EBITDA of $14 million and GAAP net income of $4
million, demonstrating the significant operating leverage of our
business. Axonics is growing rapidly and profitably as we advance
on our path to incontinence market leadership.”
3Q23 Financial Results
- Net revenue was $93.1 million in 3Q23, an increase of 32%
compared to the prior year period.
- Sacral neuromodulation revenue was $73.9 million, of which
$72.2 million was generated in the U.S. and the remainder in
international markets.
- Bulkamid revenue was $19.2 million, of which $15.6 million was
generated in the U.S. and the remainder in international
markets.
- Gross margin was 74.2% in 3Q23 compared to 72.8% in the prior
year period.
- Operating expenses were $69.8 million in 3Q23 compared to $67.6
million in the prior year period.
- Excluding acquisition-related costs, adjusted operating
expenses were $59.4 million in the prior year period.
- Adjusted EBITDA was $14.0 million in 3Q23 compared to $3.3
million in the prior year period.
- Net income was $3.9 million in 3Q23 compared to a net loss of
$16.3 million in the prior year period.
- Cash, cash equivalents and short-term investments were $344.7
million as of September 30, 2023, an increase of $13.2 million
compared to June 30, 2023.
Fiscal Year 2023 Revenue Guidance
Axonics has updated its fiscal year 2023 revenue guidance as
follows:
- Total company revenue of $362 million, an increase of 32%
compared to fiscal year 2022. This compares to prior fiscal year
2023 revenue guidance of $358 million.
- Sacral neuromodulation revenue of $288.5 million, an increase
of 30% compared to fiscal year 2022.
- Bulkamid revenue of $73.5 million, an increase of 42% compared
to fiscal year 2022.
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.
To access the conference call by telephone, interested parties may
register at the following link: Axonics 3Q23 registration.
For those not planning to ask a question, the company recommends
accessing the conference call by webcast at the following link:
Axonics 3Q23 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. 2 on the
2023 Financial Times ranking of the fastest growing companies in
the Americas and No. 4 on the 2022 Deloitte Technology Fast
500.
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. 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, acquired in-process research
and development expense, 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)
September 30,
December 31,
2023
2022
(unaudited)
ASSETS
Current assets
Cash and cash equivalents
$
147,323
$
238,846
Short-term investments
197,393
118,365
Accounts receivable, net of allowance for
credit losses of $380 and $321 at September 30, 2023 and December
31, 2022, respectively
48,944
44,817
Inventory, net
74,909
55,765
Prepaid expenses and other current
assets
6,816
7,282
Total current assets
475,385
465,075
Property and equipment, net
6,556
6,798
Intangible assets, net
80,274
86,253
Other assets
3,245
6,813
Goodwill
95,287
94,414
Total assets
$
660,747
$
659,353
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities
Accounts payable
$
14,666
$
9,070
Accrued liabilities
5,962
6,520
Accrued compensation and benefits
12,994
15,495
Operating lease liabilities, current
portion
1,971
1,562
Other current liabilities
—
32,600
Total current liabilities
35,593
65,247
Operating lease liabilities, net of
current portion
876
7,555
Deferred tax liabilities, net
13,658
16,412
Total liabilities
50,127
89,214
Commitments and contingencies
Stockholders’ equity
Preferred stock, par value $0.0001 per
share; 10,000,000 shares authorized, no shares issued and
outstanding at September 30, 2023 and December 31, 2022
—
—
Common stock, par value $0.0001,
75,000,000 shares authorized at September 30, 2023 and December 31,
2022; 50,669,203 and 49,546,727 shares issued and outstanding at
September 30, 2023 and December 31, 2022, respectively
5
5
Additional paid-in capital
1,022,052
969,545
Accumulated deficit
(386,926
)
(374,264
)
Accumulated other comprehensive loss
(24,511
)
(25,147
)
Total stockholders’ equity
610,620
570,139
Total liabilities and stockholders’
equity
$
660,747
$
659,353
Axonics, Inc.
Consolidated Statements of
Comprehensive Loss
(in thousands, except share
and per share data)
(unaudited)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2023
2022
2023
2022
Net revenue
$
93,100
$
70,384
$
256,644
$
187,784
Cost of goods sold
23,996
19,124
64,850
53,086
Gross profit
69,104
51,260
191,794
134,698
Operating expenses
Research and development
8,167
7,936
25,172
26,307
General and administrative
11,778
9,389
34,659
29,974
Sales and marketing
47,544
39,751
134,468
112,195
Amortization of intangible assets
2,302
2,317
6,803
7,112
Acquisition-related costs
—
8,242
2,368
20,447
Acquired in-process research &
development
—
—
15,447
—
Total operating expenses
69,791
67,635
218,917
196,035
Loss from operations
(687
)
(16,375
)
(27,123
)
(61,337
)
Other income (expense)
Interest and other income
4,271
1,501
12,149
1,904
Interest and other expense
(83
)
(1,898
)
774
(3,026
)
Other income (expense), net
4,188
(397
)
12,923
(1,122
)
Income (loss) before income tax
benefit
3,501
(16,772
)
(14,200
)
(62,459
)
Income tax benefit
(427
)
(520
)
(1,538
)
(2,096
)
Net income (loss)
3,928
(16,252
)
(12,662
)
(60,363
)
Foreign currency translation
adjustment
(6,185
)
(12,057
)
636
(29,625
)
Comprehensive loss
$
(2,257
)
$
(28,309
)
$
(12,026
)
$
(89,988
)
Net income (loss) per share, basic
$
0.08
$
(0.34
)
$
(0.26
)
$
(1.31
)
Weighted-average shares used to compute
basic net income (loss) per share
49,244,981
47,208,192
48,973,252
46,185,209
Net income (loss) per share, diluted
$
0.08
$
(0.34
)
$
(0.26
)
$
(1.31
)
Weighted-average shares used to compute
diluted net income (loss) per share
50,086,491
47,208,192
48,973,252
46,185,209
Axonics, Inc.
Net Revenue by Product and
Region
(in thousands)
(unaudited)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2023
2022
2023
2022
Sacral neuromodulation
United States
$
72,212
$
55,610
$
198,270
$
147,793
International
1,737
1,249
5,025
3,894
Sacral neuromodulation total
$
73,949
$
56,859
$
203,295
$
151,687
Bulkamid
United States
$
15,579
$
11,045
$
41,998
$
27,837
International
3,572
2,480
11,351
8,260
Bulkamid total
$
19,151
$
13,525
$
53,349
$
36,097
Total net revenue
$
93,100
$
70,384
$
256,644
$
187,784
Axonics, Inc.
Reconciliation of GAAP Net
Income (Loss) to Adjusted EBITDA
(in thousands)
(unaudited)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2023
2022
2023
2022
GAAP Net income (loss)
$
3,928
$
(16,252
)
$
(12,662
)
$
(60,363
)
Non-GAAP Adjustments
Interest and other income
(4,271
)
(1,501
)
(12,149
)
(1,904
)
Interest and other expense
83
1,898
(774
)
3,026
Income tax benefit
(427
)
(520
)
(1,538
)
(2,096
)
Depreciation and amortization expense
3,254
2,921
9,295
8,841
Stock-based compensation expense
11,470
8,218
33,388
23,261
Acquisition-related costs
—
8,242
2,368
20,447
Acquired in-process research &
development
—
—
15,447
—
Impairment expense
—
287
—
287
Adjusted EBITDA
$
14,037
$
3,293
$
33,375
$
(8,501
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231030019757/en/
Axonics contact: Neil Bhalodkar 949-336-5293
IR@axonics.com
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