UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 11, 2023
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(Exact name of registrant as specified in its charter)
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| (State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) | ||||||||||||
(Address of principal executive offices) (Zip Code)
(949 ) 396-6322
(Registrant’s telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | ||||||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | ||||||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | ||||||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | ||||||||
Securities registered pursuant to Section 12(b) of the Exchange Act:
| Title of class | Trading symbol | Name of exchange on which registered | ||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
| Emerging growth company | |||||||||||
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. Results of Operations and Financial Condition.
On January 11, 2023, Axonics, Inc. (the Company) issued a press release announcing its preliminary unaudited revenue for the fiscal year ended December 31, 2022, based on the information and data currently available. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section, nor shall it be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |||||||
| 99.1 | ||||||||
| 104 | Cover Page Interactive Date File - the cover page XBRL tags are embedded within the Inline XBRL document. | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| AXONICS, INC. | ||||||||||||||
| Date: January 11, 2023 | By: | /s/ Raymond W. Cohen | ||||||||||||
| Raymond W. Cohen | ||||||||||||||
| Chief Executive Officer | ||||||||||||||
Exhibit 99.1
Axonics Reports Preliminary Fiscal Year 2022 Revenue and Provides Fiscal Year 2023 Revenue Guidance
4Q22 total company net revenue expected to be $85.6 to $86.0 million, an increase of 61% y/y
Fiscal year 2022 total company net revenue expected to be in the range of $273.6 million, an increase of 52% y/y
Fiscal year 2023 revenue guidance of $342 million, an increase of 25% y/y
IRVINE, Calif. – January 11, 2023 – 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 preliminary unaudited revenue for the fiscal year ended December 31, 2022 and issued fiscal year 2023 revenue guidance.
“This quarter’s record revenue result reflects the growing demand for our best-in-class incontinence products,” said Raymond W. Cohen, chief executive officer of Axonics. “Our U.S. commercial team is continuing to take advantage of increased patient awareness and the overwhelmingly positive physician response to the Axonics F15™ recharge-free sacral neuromodulation system while leveraging cross selling opportunities with Bulkamid®. Our unique hydrogel generated another record revenue quarter and in fiscal year 2022, Bulkamid has been used to treat over 50,000 women with stress urinary incontinence.”
Cohen continued, “In 2022, in addition to strong commercial execution, we continued to make progress on several key initiatives, including our direct-to-consumer advertising campaign and expansion of our in-house manufacturing capabilities that has benefited gross margin. We look forward to FDA approval of our fourth-generation rechargeable sacral neuromodulation system in 1Q23 and remain confident that our commitment to innovation, quality and providing physicians and patients strong clinical support will continue to drive market expansion and advance Axonics on its path to incontinence market leadership.”
The preliminary results below are unaudited and remain subject to adjustment. Axonics will report complete financial results and hold a corresponding conference call on March 1, 2023.
4Q22 Revenue
•Total company net revenue is expected to be $85.6 to $86.0 million, an increase of 61% compared to $53.1 million in the prior year period.
◦Sacral neuromodulation revenue is expected to be $70.2 to $70.4 million, an increase of 58% compared to $44.4 million in the prior year period.
◦Bulkamid revenue is expected to be $15.4 to $15.6 million, an increase of 78% compared to $8.7 million in the prior year period.
Fiscal Year 2022 Revenue
•Total company net revenue is expected to be in the range of $273.6 million, an increase of 52% compared to $180.3 million in fiscal year 2021.
◦Sacral neuromodulation revenue is expected to be in the range of $222.0 million, an increase of 41% compared to $157.6 million in fiscal year 2021.
◦Bulkamid revenue is expected to be in the range of $51.6 million, an increase of 127% compared to $22.7 million in fiscal year 2021.
Fiscal Year 2023 Revenue Guidance
•Total company net revenue is expected to be $342 million, which is based on sacral neuromodulation and Bulkamid revenue each growing 25% compared to fiscal year 2022.
◦Sacral neuromodulation revenue of $277.5 million.
◦Bulkamid revenue of $64.5 million.
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. 1 on the 2022 Financial Times ranking of the 500 fastest growing companies in the Americas and No. 4 on the 2022 Deloitte Technology Fast 500™ following its No. 1 ranking in 2021.
Axonics sacral neuromodulation (SNM) systems provide patients 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 (SUI). Overactive bladder affects an estimated 87 million adults in the U.S. and Europe, with an additional 40 million adults affected by 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 “plans,” “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 contact:
Neil Bhalodkar
Neil Bhalodkar
949-336-5293
ir@axonics.com