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): May 5, 2022
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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 May 5, 2022, Axonics, Inc. (the Company) issued a press release announcing its financial results for the quarter ended March 31, 2022. 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: May 5, 2022 | By: | /s/ Raymond W. Cohen | ||||||||||||
| Raymond W. Cohen | ||||||||||||||
| Chief Executive Officer | ||||||||||||||
Exhibit 99.1
Axonics® Reports First Quarter 2022 Financial Results
IRVINE, Calif. – May 5, 2022 – 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, 2022.
“We are pleased with this quarter’s revenue result considering the significant impact the Omicron surge had on elective procedures in January and February,” said Raymond W. Cohen, chief executive officer of Axonics. “Sacral neuromodulation procedure volumes recovered nicely in March and continued to trend favorably in April. Bulkamid® generated yet another quarter of record revenue and we are delighted to report that over 32,000 women have had their stress urinary incontinence symptoms treated with Bulkamid from the time we acquired the product last year.”
Cohen continued, “In April, we commenced the broad commercial launch of the Axonics F15™, our newly developed, long-lived, recharge-free sacral neuromodulation system. Physician response has been overwhelmingly positive, and we are confident this new recharge-free option will expand the sacral neuromodulation market while also accelerating the conversion of accounts to Axonics. We also recently launched our direct-to-consumer television advertising campaign, which aims to reduce stigma, increase awareness for Axonics therapies, and encourage women to consult and seek treatment from a physician who specializes in bladder and bowel dysfunction. With a full portfolio of incontinence solutions, increased public awareness for our innovative products, and a keen focus on execution, Axonics is well positioned to achieve its mission of treating more adults suffering from incontinence.”
First Quarter 2022 Financial Results
•Net revenue was $48.4 million in first quarter 2022, an increase of 41% compared to $34.4 million in the prior year period.
◦Sacral neuromodulation revenue was $39.1 million, of which $37.7 million was generated in the U.S. and the remainder in international markets.
◦Bulkamid revenue was $9.4 million, of which $6.6 million was generated in the U.S. and the remainder in international markets.
•Gross margin was 68.7% in first quarter 2022 compared to 59.3% in the prior year period.
•Operating expenses were $56.8 million in first quarter 2022 compared to $42.0 million in the prior year period.
•Net loss was $22.7 million in first quarter 2022 compared to net loss of $22.5 million in the prior year period.
•Cash and cash equivalents were $213.2 million as of March 31, 2022.
Fiscal Year 2022 Revenue Guidance
Axonics has updated its fiscal year 2022 revenue guidance as follows:
•Total company revenue of $238 million, an increase of 32% compared to fiscal year 2021. This compares to prior revenue guidance of $234 million.
•Sacral neuromodulation revenue of $199 million, an increase of 26% compared to fiscal year 2021.
•Bulkamid revenue of $39 million, an increase of 72% compared to fiscal year 2021.
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. The live teleconference may be accessed by dialing 866-687-5771 (U.S.) or 409-217-8725 (international) and using passcode 6152315.
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™ and the 2022 Financial Times ranking of the 500 fastest growing companies in the Americas.
Axonics’ sacral neuromodulation (SNM) systems provide patients suffering from 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 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 contact:
Neil Bhalodkar
Neil Bhalodkar
Investor Relations
949-336-5293
IR@axonics.com
Axonics, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
| March 31, | December 31, | ||||||||||
| 2022 | 2021 | ||||||||||
| (unaudited) | |||||||||||
| ASSETS | |||||||||||
| Current assets | |||||||||||
| Cash and cash equivalents | $ | 213,180 | $ | 220,878 | |||||||
| Accounts receivable, net of allowance for credit losses of $316 and $355 at March 31, 2022 and December 31, 2021, respectively | 27,425 | 29,044 | |||||||||
| Inventory, net | 61,876 | 64,946 | |||||||||
| Prepaid expenses and other current assets | 4,952 | 6,449 | |||||||||
| Total current assets | 307,433 | 321,317 | |||||||||
| Property and equipment, net | 6,907 | 6,915 | |||||||||
| Intangible assets, net | 101,179 | 106,469 | |||||||||
| Other assets | 7,494 | 7,734 | |||||||||
| Goodwill | 102,558 | 105,510 | |||||||||
| Total assets | $ | 525,571 | $ | 547,945 | |||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||||
| Current liabilities | |||||||||||
| Accounts payable | $ | 10,390 | $ | 7,654 | |||||||
| Accrued liabilities | 6,246 | 5,435 | |||||||||
| Accrued compensation and benefits | 7,480 | 12,413 | |||||||||
| Operating lease liability, current portion | 1,403 | 1,366 | |||||||||
| Total current liabilities | 25,519 | 26,868 | |||||||||
| Operating lease liability, net of current portion | 8,686 | 9,052 | |||||||||
| Deferred tax liabilities, net | 17,564 | 19,217 | |||||||||
| Other long-term liabilities | 10,370 | 10,370 | |||||||||
| Total liabilities | 62,139 | 65,507 | |||||||||
| Stockholders’ equity | |||||||||||
| Preferred stock, par value $0.0001 per share; 10,000,000 shares authorized, no shares issued and outstanding at March 31, 2022 and December 31, 2021 | — | — | |||||||||
| Common stock, par value $0.0001, 50,000,000 shares authorized at March 31, 2022 and December 31, 2021; 47,002,862 and 46,330,167 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively | 5 | 5 | |||||||||
| Additional paid-in capital | 812,141 | 803,559 | |||||||||
| Accumulated deficit | (337,234) | (314,566) | |||||||||
| Accumulated other comprehensive loss | (11,480) | (6,560) | |||||||||
| Total stockholders’ equity | 463,432 | 482,438 | |||||||||
| Total liabilities and stockholders’ equity | $ | 525,571 | $ | 547,945 | |||||||
Axonics, Inc.
Condensed Consolidated Statements of Comprehensive Loss
(in thousands, except share and per share data)
(unaudited)
| Three Months Ended March 31, | |||||||||||
| 2022 | 2021 | ||||||||||
| Net revenue | $ | 48,420 | $ | 34,373 | |||||||
| Cost of goods sold | 15,178 | 13,974 | |||||||||
| Gross profit | 33,242 | 20,399 | |||||||||
| Operating expenses | |||||||||||
| Research and development | 11,236 | 9,369 | |||||||||
| General and administrative | 10,013 | 6,626 | |||||||||
| Sales and marketing | 33,063 | 20,928 | |||||||||
| Amortization of intangible assets | 2,463 | 678 | |||||||||
| Acquisition-related costs | — | 4,414 | |||||||||
| Total operating expenses | 56,775 | 42,015 | |||||||||
| Loss from operations | (23,533) | (21,616) | |||||||||
| Other income (expense) | |||||||||||
| Interest income | 43 | 8 | |||||||||
| Interest and other expense | (289) | (1,450) | |||||||||
| Other expense, net | (246) | (1,442) | |||||||||
| Loss before income tax benefit | (23,779) | (23,058) | |||||||||
| Income tax benefit | (1,111) | (555) | |||||||||
| Net loss | (22,668) | (22,503) | |||||||||
| Foreign currency translation adjustment | (4,920) | (2,202) | |||||||||
| Comprehensive loss | $ | (27,588) | $ | (24,705) | |||||||
| Net loss per share, basic and diluted | $ | (0.50) | $ | (0.57) | |||||||
| Weighted-average shares used to compute basic and diluted net loss per share | 45,139,038 | 39,613,964 | |||||||||
Axonics, Inc.
Net Revenue by Product and Region
(in thousands)
(unaudited)
| Three Months Ended March 31, | |||||||||||
| 2022 | 2021 | ||||||||||
| Sacral neuromodulation | |||||||||||
| United States | $ | 37,715 | $ | 31,745 | |||||||
| International | 1,355 | 1,158 | |||||||||
| Sacral neuromodulation total | $ | 39,070 | $ | 32,903 | |||||||
| Bulkamid | |||||||||||
| United States | $ | 6,569 | $ | 578 | |||||||
| International | 2,781 | 892 | |||||||||
| Bulkamid total | $ | 9,350 | $ | 1,470 | |||||||
| Total net revenue | $ | 48,420 | $ | 34,373 | |||||||