Generated quarterly revenue of $70.7 million,
an increase of 46% year over year
Fiscal year 2023 revenue guidance increased to
$348 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 March 31, 2023.
“Our commercial team continues to execute at a high level,
generating revenue growth of 46% year over year in the first
quarter,” said Raymond W. Cohen, chief executive officer. “Our
sacral neuromodulation growth was driven by higher utilization and
share gains while Bulkamid® continues to benefit from physicians
enthusiastically adopting our durable hydrogel to treat their
stress urinary incontinence patients. Based on the strong results
generated in the first quarter, we are raising our fiscal year 2023
revenue guidance to $348 million, representing 27% growth year over
year.”
Cohen continued, “We continue to focus on bringing new
innovations to the incontinence market, with the goal of increasing
the penetration of advanced therapies for this vastly undertreated
patient population. In the first quarter, we received FDA approval
and commercially launched the Axonics R20™, our fourth-generation
rechargeable SNM system that requires recharging just once every
six to ten months for one hour. In addition, last week we announced
the acquisition of a technology to facilitate easier and faster
lead placement during the SNM external trial. We are confident that
this commitment to innovation, increasing public awareness, and
providing physicians and patients strong clinical support will
continue to drive market expansion and advance Axonics on its path
to incontinence market leadership.”
1Q23 Financial Results
- Net revenue was $70.7 million in 1Q23, an increase of 46%
compared to the prior year period.
- Sacral neuromodulation revenue was $55.2 million, of which
$53.9 million was generated in the U.S. and the remainder in
international markets.
- Bulkamid revenue was $15.5 million, of which $11.6 million was
generated in the U.S. and the remainder in international
markets.
- Gross margin was 74.3% in 1Q23 compared to 68.7% in the prior
year period.
- Operating expenses were $66.9 million in 1Q23 and included a
$1.8 million non-cash charge for the change in fair value of
contingent consideration related to the Bulkamid acquisition.
Operating expenses were $56.8 million in the prior year period.
- Excluding acquisition-related charges, adjusted operating
expenses were $65.1 million in 1Q23.
- Adjusted EBITDA was $0.9 million in 1Q23 compared to an
adjusted EBITDA loss of $13.4 million in the prior year
period.
- Net loss was $9.2 million in 1Q23 compared to a net loss of
$22.7 million in the prior year period.
- Cash, cash equivalents and short-term investments were $357
million as of March 31, 2023.
Fiscal Year 2023 Revenue Guidance
Axonics has updated its fiscal year 2023 revenue guidance as
follows:
- Total company revenue of $348 million, an increase of 27%
compared to fiscal year 2022.
- This compares to initial fiscal year 2023 revenue guidance of
$342 million.
- Sacral neuromodulation revenue of $280.5 million, an increase
of 26% compared to fiscal year 2022.
- Bulkamid revenue of $67.5 million, an increase of 31% 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 1Q23 registration.
For those not planning to ask a question, the company recommends
accessing the conference call by webcast at the following link:
Axonics 1Q23 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. 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)
March 31,
December 31,
2023
2022
(unaudited)
ASSETS
Current assets
Cash and cash equivalents
$
240,105
$
238,846
Short-term investments
116,957
118,365
Accounts receivable, net of allowance for
credit losses of $322 and $321 at March 31, 2023 and December 31,
2022, respectively
40,200
44,817
Inventory, net
66,067
55,765
Prepaid expenses and other current
assets
6,342
7,282
Total current assets
469,671
465,075
Property and equipment, net
7,017
6,798
Intangible assets, net
85,888
86,253
Other assets
6,534
6,813
Goodwill
96,581
94,414
Total assets
$
665,691
$
659,353
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities
Accounts payable
$
14,737
$
9,070
Accrued liabilities
6,640
6,520
Accrued compensation and benefits
8,836
15,495
Operating lease liability, current
portion
1,557
1,562
Other current liabilities
34,400
32,600
Total current liabilities
66,170
65,247
Operating lease liability, net of current
portion
7,178
7,555
Deferred tax liabilities, net
15,737
16,412
Total liabilities
89,085
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 March 31, 2023 and December 31, 2022
—
—
Common stock, par value $0.0001,
75,000,000 shares authorized at March 31, 2023 and December 31,
2022; 50,110,667 and 49,546,727 shares issued and outstanding at
March 31, 2023 and December 31, 2022, respectively
5
5
Additional paid-in capital
982,189
969,545
Accumulated deficit
(383,512
)
(374,264
)
Accumulated other comprehensive loss
(22,076
)
(25,147
)
Total stockholders’ equity
576,606
570,139
Total liabilities and stockholders’
equity
$
665,691
$
659,353
Axonics, Inc.
Consolidated Statements of
Comprehensive Loss
(in thousands, except share
and per share data)
(unaudited)
Three Months Ended
March 31,
2023
2022
Net revenue
$
70,650
$
48,420
Cost of goods sold
18,150
15,178
Gross profit
52,500
33,242
Operating expenses
Research and development
8,056
11,236
General and administrative
12,168
10,013
Sales and marketing
42,654
33,063
Amortization of intangible assets
2,222
2,463
Acquisition-related costs
1,766
—
Total operating expenses
66,866
56,775
Loss from operations
(14,366
)
(23,533
)
Other income (expense)
Interest and other income
3,628
43
Interest and other expense
683
(289
)
Other income (expense), net
4,311
(246
)
Loss before income tax benefit
(10,055
)
(23,779
)
Income tax benefit
(807
)
(1,111
)
Net loss
(9,248
)
(22,668
)
Foreign currency translation
adjustment
3,071
(4,920
)
Comprehensive loss
$
(6,177
)
$
(27,588
)
Net loss per share, basic and diluted
$
(0.19
)
$
(0.50
)
Weighted-average shares used to compute
basic and diluted net loss per share
48,579,084
45,139,038
Axonics, Inc.
Net Revenue by Product and
Region
(in thousands)
(unaudited)
Three Months Ended
March 31,
2023
2022
Sacral neuromodulation
United States
$
53,853
$
37,715
International
1,305
1,355
Sacral neuromodulation total
$
55,158
$
39,070
Bulkamid
United States
$
11,613
$
6,569
International
3,879
2,781
Bulkamid total
$
15,492
$
9,350
Total net revenue
$
70,650
$
48,420
Axonics, Inc.
Reconciliation of GAAP Net
Loss to Adjusted EBITDA
(in thousands)
(unaudited)
Three Months Ended
March 31,
2023
2022
GAAP Net loss
$
(9,248
)
$
(22,668
)
Non-GAAP Adjustments:
Interest and other income
(3,628
)
(43
)
Interest and other expense
(683
)
289
Income tax benefit
(807
)
(1,111
)
Depreciation and amortization expense
2,813
3,029
Stock-based compensation expense
10,714
7,138
Acquisition-related costs
1,766
—
Adjusted EBITDA
$
927
$
(13,366
)
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version on businesswire.com: https://www.businesswire.com/news/home/20230501005562/en/
Axonics Neil Bhalodkar 949-336-5293 IR@axonics.com
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