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, 2023.
“The continued strong performance of Axonics reflects the
physician community’s preference and enthusiasm for our
incontinence products,” said Raymond W. Cohen, chief executive
officer. “Revenue grew 34% in 2023, gross margin expanded to nearly
75% and Axonics generated over $50 million of adjusted EBITDA.”
Mr. Cohen continued, “In 2023, clinicians used Axonics therapies
to treat approximately 100,000 incontinence patients globally, a
testament to our mission-driven employees and their commitment to
quality and teamwork. Our team is looking forward to the global
impact we can make as part of Boston Scientific as we endeavor to
bring these life-changing therapies to more patients than ever
before.”
Fourth Quarter 2023 Financial Results
- Net revenue was $109.7 million in fourth quarter 2023, an
increase of 28% compared to the prior year period.
- Sacral neuromodulation revenue was $88.5 million, of which
$86.6 million was generated in the U.S. and the remainder in
international markets.
- Bulkamid revenue was $21.2 million, of which $17.0 million was
generated in the U.S. and the remainder in international
markets.
- Gross margin was 75.4% in fourth quarter 2023 compared to 73.3%
in the prior year period.
- Operating expenses were $81.7 million in fourth quarter 2023
and included $3.5 million of acquisition-related costs. Operating
expenses were $66.6 million in the prior year period and included
$2.1 million of acquisition-related costs.
- Net income was $6.6 million in fourth quarter 2023 compared to
$0.7 million in the prior year period.
- Adjusted EBITDA was $18.9 million in fourth quarter 2023
compared to $10.1 million in the prior year period.
- Cash, cash equivalents, short-term investments and restricted
cash were $358 million as of December 31, 2023.
Fiscal Year 2023 Financial Results
- Net revenue was $366.4 million in fiscal year 2023, an increase
of 34% compared to the prior year.
- SNM revenue was $291.8 million, of which $284.8 million was
generated in the U.S. and the remainder in international
markets.
- Bulkamid revenue was $74.6 million, of which $59.0 million was
generated in the U.S. and the remainder in international
markets.
- Gross margin was 74.9% in fiscal year 2023 compared to 72.2% in
the prior year.
- Operating expenses were $300.6 million in fiscal year 2023 and
included $5.9 million of acquisition-related costs and a $15.4
million charge for acquired in-process research and development.
Operating expenses were $262.6 million in the prior year and
included $22.6 million of acquisition-related costs.
- Net loss was $6.1 million in fiscal year 2023 compared to net
loss of $59.7 million in the prior year.
- Adjusted EBITDA was $52.3 million in fiscal year 2023 compared
to $1.6 million in the prior year.
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 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, 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.
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.
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.
Additional Information and Where to Find It
In connection with the contemplated Merger, Axonics filed on
February 22, 2024 with the SEC a definitive proxy statement
relating to a special meeting of Axonics’ stockholders to be held
for the purpose of obtaining stockholder approval of the Merger
Agreement and other related matters (the “Proxy Statement”). The
Proxy Statement was mailed to Axonics’ stockholders on or about
February 22, 2024. Axonics may also file other documents with the
SEC regarding the contemplated Merger. This document is not a
substitute for the Proxy Statement or any other document that
Axonics has filed or may file with the SEC in connection with the
contemplated Merger. BEFORE MAKING ANY VOTING DECISION, INVESTORS
AND SECURITY HOLDERS OF AXONICS ARE URGED TO READ THE PROXY
STATEMENT, ANY AMENDMENTS OR SUPPLEMENTS THERETO, ANY OTHER
SOLICITING MATERIALS AND ANY OTHER DOCUMENTS THAT ARE FILED OR WILL
BE FILED WITH THE SEC IN CONNECTION WITH THE CONTEMPLATED MERGER OR
INCORPORATED BY REFERENCE IN THE PROXY STATEMENT BECAUSE THEY
CONTAIN OR WILL CONTAIN, AS APPLICABLE, IMPORTANT INFORMATION ABOUT
AXONICS, BOSTON SCIENTIFIC AND THE CONTEMPLATED MERGER. Investors
and security holders may obtain free copies of the Proxy Statement
and other filings containing important information about Axonics on
the SEC’s website at www.sec.gov, on Axonics’ website at
www.axonics.com or by contacting Axonics’ Investor Relations
department via email at IR@axonics.com.
Participants in the Solicitation
Axonics and its directors and executive officers may, under SEC
rules, be deemed participants in the solicitation of proxies from
the stockholders of Axonics in connection with the contemplated
Merger. Information regarding the identity of potential
participants in the solicitation of proxies in connection with the
proposed Merger, and their direct or indirect interests, by
security holdings or otherwise, is included in the Proxy Statement.
Additional information regarding Axonics’ directors and executive
officers is contained in the Proxy Statement, Axonics’ Definitive
Proxy Statement on Schedule 14A for Axonics’ 2023 Annual Meeting of
Stockholders, which was filed with the SEC on May 1, 2023 (and
specifically, the following sections: “Security Ownership of
Certain Beneficial Owners, Executive Officers and Directors”,
“Certain Relationships and Related-Party Transactions”, “Executive
Officers”, “Proposal 1–Election of Directors”, “Director
Compensation”, and “Executive Compensation”) and in Axonics’
Current Report on Form 8-K, which was filed with the SEC on October
4, 2023. To the extent holdings of the Company’s securities by the
directors or executive officers have changed since the amounts set
forth in the Proxy Statement, such changes have been or will be
reflected on Initial Statement of Beneficial Ownership of
Securities on Form 3, Statement of Changes in Beneficial Ownership
on Form 4, or Annual Statement of Changes in Beneficial Ownership
on Form 5 filed with the SEC, which are available at EDGAR Search
Results (sec.gov). These documents (when available) are available
free of charge as described in the preceding section.
Axonics, Inc.
Consolidated Balance
Sheets
(in thousands, except share
and per share data)
December 31,
2023
2022
(unaudited)
ASSETS
Current assets
Cash and cash equivalents
$
104,811
$
238,846
Short-term investments
240,149
118,365
Accounts receivable, net of allowance for
credit losses of $442 and $321 at December 31, 2023 and 2022,
respectively
57,243
44,817
Inventory, net
79,940
55,765
Prepaid expenses and other current
assets
9,279
7,282
Total current assets
491,422
465,075
Restricted cash
12,714
—
Property and equipment, net
10,760
6,798
Intangible assets, net
81,375
86,253
Other assets
24,235
6,813
Goodwill
99,417
94,414
Total assets
$
719,923
$
659,353
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities
Accounts payable
$
18,452
$
9,070
Accrued liabilities
10,527
6,520
Accrued compensation and benefits
15,060
15,495
Operating lease liabilities, current
portion
1,777
1,562
Other current liabilities
—
32,600
Total current liabilities
45,816
65,247
Operating lease liabilities, net of
current portion
25,840
7,555
Deferred tax liabilities, net
10,703
16,412
Total liabilities
82,359
89,214
Stockholders’ equity
Preferred stock, par value $0.0001 per
share; 10,000,000 shares authorized, no shares issued and
outstanding at December 31, 2023 and 2022
—
—
Common stock, par value $0.0001 per share,
75,000,000 shares authorized at December 31, 2023 and 2022;
50,770,520 and 49,546,727 shares issued and outstanding at December
31, 2023 and 2022, respectively
5
5
Additional paid-in capital
1,033,778
969,545
Accumulated deficit
(380,352
)
(374,264
)
Accumulated other comprehensive loss
(15,867
)
(25,147
)
Total stockholders’ equity
637,564
570,139
Total liabilities and stockholders’
equity
$
719,923
$
659,353
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,
2023
2022
2023
2022
(unaudited)
(unaudited)
(unaudited)
Net revenue
$
109,735
$
85,918
$
366,379
$
273,702
Cost of goods sold
26,975
22,951
91,825
76,037
Gross profit
82,760
62,967
274,554
197,665
Operating expenses
Research and development
9,714
8,103
34,886
34,410
General and administrative
11,095
10,264
45,754
40,238
Sales and marketing
55,094
43,824
189,562
156,019
Amortization of intangible assets
2,261
2,271
9,064
9,383
Acquisition-related costs
3,530
2,114
5,898
22,561
Acquired in-process research &
development
—
—
15,447
—
Total operating expenses
81,694
66,576
300,611
262,611
Income (loss) from operations
1,066
(3,609
)
(26,057
)
(64,946
)
Other income (expense)
Interest and other income
4,541
3,229
16,690
5,133
Loss on disposal of property and
equipment
(1
)
(69
)
(1
)
(69
)
Interest and other (expense) income
(150
)
592
624
(2,434
)
Other income, net
4,390
3,752
17,313
2,630
Income (loss) before income tax (benefit)
expense
5,456
143
(8,744
)
(62,316
)
Income tax benefit
(1,118
)
(522
)
(2,656
)
(2,618
)
Net income (loss)
6,574
665
(6,088
)
(59,698
)
Foreign currency translation
adjustment
8,644
11,038
9,280
(18,587
)
Comprehensive income (loss)
$
15,218
$
11,703
$
3,192
$
(78,285
)
Net income (loss) per share, basic
$
0.13
$
0.01
$
(0.12
)
$
(1.28
)
Weighted-average shares used to compute
basic net income (loss) per share
49,402,597
48,166,003
49,081,470
46,684,478
Net income (loss) per share, diluted
$
0.13
$
0.01
$
(0.12
)
$
(1.28
)
Weighted-average shares used to compute
basic net income (loss) per share
50,941,760
50,460,039
49,081,470
46,684,478
Axonics, Inc.
Net Revenue by Product and
Region
(in thousands)
Three Months Ended December
31,
Years Ended December
31,
2023
2022
2023
2022
(unaudited)
(unaudited)
(unaudited)
SNM
United States
$
86,576
$
69,068
$
284,846
$
216,861
International
1,934
1,236
6,959
5,130
SNM total
$
88,510
$
70,304
$
291,805
$
221,991
Bulkamid
United States
$
17,038
$
12,341
$
59,036
$
40,178
International
4,187
3,273
15,538
11,533
Bulkamid total
$
21,225
$
15,614
$
74,574
$
51,711
Total net revenue
$
109,735
$
85,918
$
366,379
$
273,702
Axonics, Inc.
Reconciliation of GAAP Net
Income (Loss) to Adjusted EBITDA
(in thousands)
(unaudited)
Three Months Ended December
31,
Years Ended December
31,
2023
2022
2023
2022
GAAP Net income (loss)
$
6,574
$
665
$
(6,088
)
$
(59,698
)
Non-GAAP Adjustments:
Interest and other income
(4,541
)
(3,229
)
(16,690
)
(5,133
)
Interest and other expense
150
(592
)
(624
)
2,434
Income tax benefit
(1,118
)
(522
)
(2,656
)
(2,618
)
Depreciation and amortization expense
3,192
2,880
12,487
11,721
Stock-based compensation expense
11,148
8,757
44,536
32,018
Acquisition-related costs
3,530
2,114
5,898
22,561
Acquired in-process research &
development
—
—
15,447
—
Loss on disposal of property and
equipment
1
69
1
69
Impairment expense
—
—
—
287
Adjusted EBITDA
$
18,936
$
10,142
$
52,311
$
1,641
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240228530784/en/
Axonics contact: Neil Bhalodkar 949-336-5293
IR@axonics.com
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