Axonics® Reports Fourth Quarter and Fiscal Year 2021 Financial Results
02/24/2022 - 04:01 PM
Total revenue of $53.1 million 53% year over year
Fiscal year 2022 revenue outlook of $234 million 30% year over year
IRVINE, Calif. --(BUSINESS WIRE)--
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, 2021 .
“We are proud of our fourth quarter and fiscal year 2021 results considering the disruption Covid-19 has had on elective procedures in the U.S. and around the world,” said Raymond W. Cohen , chief executive officer of Axonics . “In 2021, in addition to strong commercial execution, Axonics made important progress on several strategic initiatives, including the successful acquisition and launch of Bulkamid® in the U.S. , growth of our commercial field team, expansion of our in-house manufacturing capabilities, and the FDA submission of our recharge-free SNM system.”
Cohen continued, “We expect to begin shipping our long-lived, recharge-free SNM system in early second quarter following FDA approval. We believe this new device will set a new standard for what is possible in the SNM category. We are also in the final stages of launching a national television direct-to-consumer advertising campaign to broaden awareness for Axonics therapies that treat all forms of incontinence. We remain confident that our commitment to innovation, quality and providing physicians and patients strong support will continue to drive market expansion and advance Axonics on its path to market leadership.”
Fourth Quarter 2021 Financial Results
Net revenue was $53.1 million 53% compared to $34.8 million
Sacral neuromodulation (SNM) revenue was $44.4 million $43.7 million U.S. and the remainder in select international markets.
Bulkamid revenue was $8.7 million $5.8 million U.S. and the remainder in international markets.
Gross margin was 66.6% in fourth quarter 2021 compared to 63.6% in the prior year period.
Operating expenses were $53.1 million $33.0 million
Net loss was $15.2 million $11.3 million
As of December 31, 2021 , cash and cash equivalents were $220.9 million
Fiscal Year 2021 Financial Results
Net revenue was $180.3 million 62% compared to $111.5 million
SNM revenue was $157.6 million 41% compared to $111.5 million
Bulkamid revenue was $22.7 million (1)
Gross margin was 64.2% in fiscal year 2021 compared to 60.2% in the prior year.
Operating expenses were $187.5 million $120.9 million
Net loss was $80.1 million $54.9 million
___________
(1) The acquisition of Bulkamid was completed on February 25, 2021 . Reported revenue includes sales from February 26, 2021 onwards.
Fiscal Year 2022 Revenue Outlook
Axonics continues to closely monitor the impact that the Covid-19 pandemic has had, and continues to have, on elective procedure volumes.
Axonics’ fiscal year 2022 revenue outlook is as follows:
Total company revenue of $234 million 30% compared to fiscal year 2021.
SNM revenue of $197 million 25% compared to fiscal year 2021.
Bulkamid revenue of $37 million 63% compared to fiscal year 2021.
Webcast and Conference Call
Axonics will host a conference call today, February 24, 2022 , at 4:30 p.m. Eastern Time , to discuss financial results and recent business developments. The live teleconference may be accessed by dialing 866-687-5771 (U.S. ) or 409-217-8725 (international) and using passcode 6189042.
A live webcast of the conference call may be accessed by visiting the Events & Presentations section of the Axonics investor relations website. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the Axonics website.
About Axonics
Based in Irvine, Calif. , 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 2021 Deloitte Technology Fast 500™, a ranking of the 500 fastest-growing technology, media, telecommunications, life sciences, fintech, and energy tech companies in North America .
The company’s rechargeable sacral neuromodulation (SNM) system provides patients suffering from 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 (SUI). Overactive bladder affects an estimated 87 million adults in the U.S. and Europe , with an additional 40 million adults estimated to suffer from fecal incontinence. SUI affects an estimated 29 million women in the U.S. alone. 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 “planned,” “expects,” “believes,” “anticipates,” “designed,” 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.
Axonics, Inc.
Consolidated Balance Sheets
(in thousands, except share and per share data)
December 31 ,
2021
2020
(unaudited)
ASSETS
Current assets
Cash and cash equivalents
$
220,878
$
241,181
Accounts receivable, net of allowance for credit losses of $355 and $465 at December 31, 2021 and 2020, respectively
29,044
18,270
Inventory, net
64,946
63,060
Prepaid expenses and other current assets
6,449
5,435
Total current assets
321,317
327,946
Property and equipment, net
6,915
6,328
Intangible assets, net
106,469
196
Other assets
7,734
7,736
Goodwill
105,510
—
Total assets
$
547,945
$
342,206
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable
$
7,654
$
10,660
Accrued liabilities
5,435
6,684
Accrued compensation and benefits
12,413
5,948
Operating lease liability, current portion
1,366
1,280
Debt, net of unamortized debt issuance costs, current portion
—
21,110
Total current liabilities
26,868
45,682
Operating lease liability, net of current portion
9,052
9,154
Deferred tax liabilities, net
19,217
—
Other long-term liabilities
10,370
—
Total liabilities
65,507
54,836
Stockholders’ equity
Preferred stock, par value $0.0001 per share; 10,000,000 shares authorized, no shares issued and outstanding at December 31, 2021 and 2020
—
—
Common stock, par value $0.0001 per share, 50,000,000 shares authorized at December 31, 2021 and 2020; 46,330,167 and 39,931,030 shares issued and outstanding at December 31, 2021 and 2020, respectively
5
4
Additional paid-in capital
803,559
522,296
Accumulated deficit
(314,566
)
(234,499
)
Accumulated other comprehensive loss
(6,560
)
(431
)
Total stockholders’ equity
482,438
287,370
Total liabilities and stockholders’ equity
$
547,945
$
342,206
Axonics, Inc.
Consolidated Statements of Comprehensive Loss
(in thousands, except share and per share data)
Three Months Ended December 31 ,
Years Ended December 31 ,
2021
2020
2021
2020
(unaudited)
(unaudited)
(unaudited)
Net revenue
$ 53,135
$ 34,783
$ 180,290
$ 111,535
Cost of goods sold
17,744
12,652
64,572
44,444
Gross profit
35,391
22,131
115,718
67,091
Operating expenses
Research and development
10,182
8,111
37,297
29,055
General and administrative
9,404
6,588
32,785
25,551
Sales and marketing
31,338
18,284
105,789
66,130
Amortization of intangible assets
2,147
29
7,241
115
Acquisition-related costs
—
—
4,414
—
Total operating expenses
53,071
33,012
187,526
120,851
Loss from operations
(17,680
)
(10,881
)
(71,808
)
(53,760
)
Other income (expense)
Interest income
16
19
40
761
Loss on disposal of property and equipment
(91
)
(41
)
(91
)
(41
)
Interest and other expense
102
(445
)
(7,426
)
(1,874
)
Other income (expense), net
27
(467
)
(7,477
)
(1,154
)
Loss before income tax (benefit) expense
(17,653
)
(11,348
)
(79,285
)
(54,914
)
Income tax (benefit) expense
(2,487
)
—
782
1
Net loss
(15,166
)
(11,348
)
(80,067
)
(54,915
)
Foreign currency translation adjustment
352
183
(6,129
)
(3
)
Comprehensive loss
$ (14,814
)
$ (11,165
)
$ (86,196
)
$ (54,918
)
Net loss per share, basic and diluted
$ (0.34
)
$ (0.29
)
$ (1.86
)
$ (1.48
)
Weighted-average shares used to compute basic and diluted net loss per share
44,960,262
38,971,859
43,072,298
36,981,335
Axonics, Inc.
Net Revenue by Product and Region
(in thousands)
Three Months Ended December 31 ,
Years Ended December 31 ,
2021
2020
2021
2020
(unaudited)
(unaudited)
(unaudited)
SNM
United States
$ 43,702
$ 33,709
$ 153,837
$ 107,542
International
722
1,074
3,753
3,993
SNM total
$ 44,424
$ 34,783
$ 157,590
$ 111,535
Bulkamid
United States
$ 5,790
$ —
$ 12,660
$ —
International
2,921
—
10,040
—
Bulkamid total
$ 8,711
$ —
$ 22,700
$ —
Total net revenue
$ 53,135
$ 34,783
$ 180,290
$ 111,535
View source version on businesswire.com : https://www.businesswire.com/news/home/20220224005983/en/
Axonics contactNeil Bhalodkar
ir@axonics.com
Source: Axonics, Inc.
