Axonics, Inc. (Nasdaq: AXNX), a medical technology company that
develops, manufactures and commercializes innovative and minimally
invasive products to treat bladder and bowel dysfunction, today
reported financial results for the three months ended September 30,
2024.
“Axonics continued to execute at a high level in the third
quarter, generating revenue growth of 25% year over year,” said
Raymond W. Cohen, chief executive officer. “Revenue growth for both
sacral neuromodulation and Bulkamid® was driven by higher
utilization at existing customers and the onboarding of new
accounts.”
Mr. Cohen continued, “Our commitment to innovation, quality,
direct-to-consumer advertising and providing strong clinical
support continues to expand the market for life-changing
incontinence therapies and propel Axonics on its path to market
leadership. We look forward to the global impact the Axonics
portfolio can make as part of Boston Scientific as we endeavor to
treat more patients than ever before.”
Third Quarter 2024 Financial Results
- Net revenue was $116.2 million, an increase of 25% compared to
the prior year period.
- Sacral neuromodulation revenue was $92.3 million, an increase
of 25% compared to the prior year period.
- Bulkamid revenue was $23.8 million, an increase of 25% compared
to the prior year period.
- Gross margin was 77.2% compared to 74.2% in the prior year
period.
- Loss from operations was $6.3 million and includes $8 million
of one-time legal and acquisition-related costs. This compares to a
loss from operations of $0.7 million in the prior year period.
- Net loss was $21,000 compared to net income of $3.9 million in
the prior year period.
- Adjusted EBITDA was $23.6 million compared to $14.0 million in
the prior year period.
- Cash, cash equivalents, short-term investments and restricted
cash were $367 million as of September 30, 2024.
About Axonics
Axonics is a global medical technology company that is
developing and commercializing novel products for adults with
bladder and bowel dysfunction. Axonics ranked No. 2 on the 2023
Financial Times ranking of the fastest growing companies in the
Americas after being ranked No. 1 in 2022.
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, Axonics’
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.
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 loss before other
income/expense (including interest), income tax expense (benefit),
depreciation and amortization expense, stock-based compensation
expense, acquisition-related costs, cash compensation in lieu of
equity compensation due to pending merger, one-time
litigation-related expense, 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 (Loss) Income 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.
Cautionary Statement Regarding Forward-Looking
Statements
This press release contains “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. Forward-looking
statements can be identified by words like “may,” “will,” “likely,”
“should,” “expect,” “anticipate,” “future,” “plan,” “believe,”
“intend,” “goal,” “seek,” “endeavor,” “estimate,” “project,”
“continue,” and variations of such words and similar expressions.
These forward-looking statements are not guarantees of future
performance and involve risks, assumptions, and uncertainties,
including, but not limited to, risks related to: Axonics’ ability
to consummate the transactions contemplated by the Agreement and
Plan of Merger, dated January 8, 2024 (the “Merger Agreement”), by
and among Axonics, Boston Scientific Corporation (“Boston
Scientific”), and Sadie Merger Sub, Inc., a wholly owned subsidiary
of Boston Scientific (“Merger Sub”), providing for the merger of
Merger Sub with and into Axonics with Axonics continuing as the
surviving company and a wholly owned subsidiary of Boston
Scientific (the “Merger”), in a timely manner or at all; the risk
that the Merger Agreement may be terminated in circumstances
requiring the payment by Axonics of a termination fee; the
satisfaction (or waiver) of the conditions to the closing of the
Merger; potential delays in consummating the Merger; the occurrence
of any event, change or other circumstance or condition that could
give rise to termination of the Merger Agreement; Axonics’ ability
to timely and successfully realize the anticipated benefits of the
Merger; the ability to successfully integrate the businesses of
Axonics and Boston Scientific; the effect of the announcement or
pendency of the Merger on Axonics’ current plans, business
relationships, operating results and business generally; the effect
of limitations placed on Axonics’ business under the Merger
Agreement; significant transaction costs and unknown liabilities;
litigation or regulatory actions related to the Merger Agreement or
Merger; FDA or other U.S. or foreign regulatory or legal actions or
changes affecting Axonics or Axonics’ industry; the results of any
ongoing or future legal proceedings, including the litigation with
Medtronic, Inc., Medtronic Puerto Rico Operations Co., Medtronic
Logistics LLC and Medtronic USA, Inc. (the “Medtronic Litigation”);
any termination or loss of intellectual property rights, including
as a result of the Medtronic Litigation; introductions and
announcements of new technologies by Axonics, any commercialization
partners or Axonics’ competitors, and the timing of these
introductions and announcements; changes in macroeconomic and
market conditions and volatility, including the risk of recession,
inflation, supply chain constraints or disruptions and rising
interest rates; and economic and market conditions in general and
in the medical technology industry specifically, including the size
and growth, if any, of Axonics’ markets, and risks related to other
factors described under “Risk Factors” in other reports and
statements filed with the U.S. Securities and Exchange Commission
(“SEC”), including Axonics’ most recent Annual Report on Form 10-K,
which is available on the investor relations section of Axonics’
website at www.axonics.com and on the SEC’s website at www.sec.gov.
Should one or more of these risks or uncertainties materialize, or
should underlying assumptions prove incorrect, actual results may
vary materially from those indicated or anticipated by these
forward-looking statements. Therefore, you should not rely on any
of these forward-looking statements.
The forward-looking statements included in this press release
are made only as of the date of this press release, and except as
otherwise required by federal securities law, Axonics does not
assume any obligation nor does it intend to publicly update or
revise any forward-looking statements to reflect new information,
changed circumstances or unanticipated events.
Axonics, Inc.
Consolidated Balance
Sheets
(in thousands, except share
and per share data)
September 30,
December 31,
2024
2023
(unaudited)
ASSETS
Current assets
Cash and cash equivalents
$
239,452
$
104,811
Short-term investments
105,773
240,149
Accounts receivable, net of allowance for
credit losses of $1,198 and $442 at September 30, 2024 and December
31, 2023, respectively
62,644
57,243
Inventory, net
113,861
79,940
Prepaid expenses and other current
assets
4,184
9,279
Total current assets
525,914
491,422
Restricted cash
22,082
12,714
Property and equipment, net
20,698
10,760
Intangible assets, net
78,454
81,375
Other assets
22,478
24,235
Goodwill
104,545
99,417
Total assets
$
774,171
$
719,923
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities
Accounts payable
$
20,109
$
18,452
Accrued liabilities
5,701
10,527
Accrued compensation and benefits
35,998
15,060
Operating lease liabilities, current
portion
2,611
1,777
Total current liabilities
64,419
45,816
Operating lease liabilities, net of
current portion
29,900
25,840
Deferred tax liabilities, net
15,363
10,703
Total liabilities
109,682
82,359
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, 2024 and December 31, 2023
—
—
Common stock, par value $0.0001,
75,000,000 shares authorized at September 30, 2024 and December 31,
2023; 51,110,021 and 50,770,520 shares issued and outstanding at
September 30, 2024 and December 31, 2023, respectively
5
5
Additional paid-in capital
1,063,185
1,033,778
Accumulated deficit
(392,586
)
(380,352
)
Accumulated other comprehensive loss
(6,115
)
(15,867
)
Total stockholders’ equity
664,489
637,564
Total liabilities and stockholders’
equity
$
774,171
$
719,923
Axonics, Inc.
Consolidated Statements of
Comprehensive Income (Loss)
(in thousands, except share
and per share data)
(unaudited)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2024
2023
2024
2023
Net revenue
$
116,193
$
93,100
$
322,167
$
256,644
Cost of goods sold
26,542
23,996
74,120
64,850
Gross profit
89,651
69,104
248,047
191,794
Operating expenses
Research and development
13,491
8,167
37,339
25,172
General and administrative
23,761
11,778
55,192
34,659
Sales and marketing
52,972
47,544
160,607
134,468
Amortization of intangible assets
2,221
2,302
6,722
6,803
Acquisition-related costs
3,474
—
9,953
2,368
Acquired in-process research &
development
—
—
—
15,447
Total operating expenses
95,919
69,791
269,813
218,917
Loss from operations
(6,268
)
(687
)
(21,766
)
(27,123
)
Other income (expense)
Interest and other income
4,704
4,271
13,379
12,149
Interest and other expense
8
(83
)
(83
)
774
Other income, net
4,712
4,188
13,296
12,923
(Loss) income before income tax (benefit)
expense
(1,556
)
3,501
(8,470
)
(14,200
)
Income tax (benefit) expense
(1,535
)
(427
)
3,764
(1,538
)
Net (loss) income
(21
)
3,928
(12,234
)
(12,662
)
Foreign currency translation
adjustment
10,438
(6,185
)
9,752
636
Comprehensive income (loss)
$
10,417
$
(2,257
)
$
(2,482
)
$
(12,026
)
Net (loss) income per share, basic
$
(0.00
)
$
0.08
$
(0.24
)
$
(0.26
)
Weighted-average shares used to compute
basic net (loss) income per share
51,088,073
49,244,981
51,010,885
48,973,252
Net (loss) income per share, diluted
$
(0.00
)
$
0.08
$
(0.24
)
$
(0.26
)
Weighted-average shares used to compute
diluted net (loss) income per share
51,088,073
50,086,491
51,010,885
48,973,252
Axonics, Inc.
Net Revenue by Product and
Region
(in thousands)
(unaudited)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2024
2023
2024
2023
Sacral neuromodulation
United States
$
90,072
$
72,212
$
248,988
$
198,270
International
2,277
1,737
6,255
5,025
Sacral neuromodulation total
$
92,349
$
73,949
$
255,243
$
203,295
Bulkamid
United States
$
19,050
$
15,579
$
52,575
$
41,998
International
4,794
3,572
14,349
11,351
Bulkamid total
$
23,844
$
19,151
$
66,924
$
53,349
Total net revenue
$
116,193
$
93,100
$
322,167
$
256,644
Axonics, Inc.
Reconciliation of GAAP Net
(Loss) Income to Adjusted EBITDA
(in thousands)
(unaudited)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2024
2023
2024
2023
GAAP Net (loss) income
$
(21
)
$
3,928
$
(12,234
)
$
(12,662
)
Non-GAAP Adjustments:
Interest and other income
(4,704
)
(4,271
)
(13,379
)
(12,149
)
Interest and other expense
(8
)
83
83
(774
)
Income tax (benefit) expense
(1,535
)
(427
)
3,764
(1,538
)
Depreciation and amortization expense
3,215
3,254
9,298
9,295
Stock-based compensation expense
8,231
11,470
26,393
33,388
Acquisition-related costs
3,474
—
9,953
2,368
Cash compensation in lieu of equity
compensation due to pending merger
10,404
—
21,586
—
One-time litigation-related expense
4,500
—
4,500
—
Acquired in-process research &
development
—
—
—
15,447
Adjusted EBITDA
$
23,556
$
14,037
$
49,964
$
33,375
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241107091750/en/
Axonics contact: Neil Bhalodkar IR@axonics.com
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