false000160375600016037562023-10-302023-10-30

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
  _________________________________________________________________
FORM 8-K
 _________________________________________________________________
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): October 30, 2023
_________________________________________________________________
Axonics, Inc.
(Exact name of registrant as specified in its charter)
_________________________________________________________________
Delaware 001-38721 45-4744083
(State or other jurisdiction
of incorporation)		 (Commission File Number) (I.R.S. Employer
Identification No.)
26 Technology Drive
Irvine, California 92618
(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)
  _________________________________________________________________
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 classTrading symbolName of exchange on which registered
Common stock, par value $0.0001 per shareAXNXNasdaq Global Select Market
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 October 30, 2023, Axonics, Inc. (the Company) issued a press release announcing its financial results for the quarter ended September 30, 2023. 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
104Cover 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: October 30, 2023
 By: /s/ Raymond W. Cohen
  Raymond W. Cohen
  Chief Executive Officer


Exhibit 99.1
Axonics Reports Third Quarter 2023 Financial Results

Generated quarterly revenue of $93.1 million, an increase of 32% year over year

Fiscal year 2023 revenue guidance increased to $362 million

IRVINE, Calif. – October 30, 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 financial results for the three months ended September 30, 2023.

“Our commercial team continues to execute at a high level, generating over 30% revenue growth in the third quarter,” said Raymond W. Cohen, chief executive officer. “Our growth was driven by higher utilization and share of wallet at existing customers and the onboarding of new accounts. Based on the strong results generated in the third quarter, we are raising our fiscal year 2023 revenue guidance to $362 million, representing growth of 32% year over year.”

Mr. Cohen continued, “In the third quarter, the company also generated adjusted EBITDA of $14 million and GAAP net income of $4 million, demonstrating the significant operating leverage of our business. Axonics is growing rapidly and profitably as we advance on our path to incontinence market leadership.”

3Q23 Financial Results
•Net revenue was $93.1 million in 3Q23, an increase of 32% compared to the prior year period.
◦Sacral neuromodulation revenue was $73.9 million, of which $72.2 million was generated in the U.S. and the remainder in international markets.
◦Bulkamid revenue was $19.2 million, of which $15.6 million was generated in the U.S. and the remainder in international markets.
•Gross margin was 74.2% in 3Q23 compared to 72.8% in the prior year period.
•Operating expenses were $69.8 million in 3Q23 compared to $67.6 million in the prior year period.
◦Excluding acquisition-related costs, adjusted operating expenses were $59.4 million in the prior year period.
•Adjusted EBITDA was $14.0 million in 3Q23 compared to $3.3 million in the prior year period.
•Net income was $3.9 million in 3Q23 compared to a net loss of $16.3 million in the prior year period.
•Cash, cash equivalents and short-term investments were $344.7 million as of September 30, 2023, an increase of $13.2 million compared to June 30, 2023.

Fiscal Year 2023 Revenue Guidance
Axonics has updated its fiscal year 2023 revenue guidance as follows:
•Total company revenue of $362 million, an increase of 32% compared to fiscal year 2022. This compares to prior fiscal year 2023 revenue guidance of $358 million.
◦Sacral neuromodulation revenue of $288.5 million, an increase of 30% compared to fiscal year 2022.


◦Bulkamid revenue of $73.5 million, an increase of 42% compared to fiscal year 2022.
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. To access the conference call by telephone, interested parties may register at the following link: Axonics 3Q23 registration.

For those not planning to ask a question, the company recommends accessing the conference call by webcast at the following link: Axonics 3Q23 webcast. A replay of the webcast will be archived in the Events section of the Axonics investor relations website.
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 and No. 4 on the 2022 Deloitte Technology Fast 500.

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.
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,” “designs,” 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.
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.

Axonics contact:
Neil Bhalodkar
949-336-5293
IR@axonics.com


Axonics, Inc.
Consolidated Balance Sheets
(in thousands, except share and per share data)
September 30,December 31,
20232022
(unaudited)
ASSETS
Current assets
Cash and cash equivalents$147,323 $238,846 
Short-term investments197,393 118,365 
Accounts receivable, net of allowance for credit losses of $380 and $321 at September 30, 2023 and December 31, 2022, respectively48,944 44,817 
Inventory, net74,909 55,765 
Prepaid expenses and other current assets6,816 7,282 
Total current assets475,385 465,075 
Property and equipment, net6,556 6,798 
Intangible assets, net80,274 86,253 
Other assets3,245 6,813 
Goodwill95,287 94,414 
Total assets$660,747 $659,353 
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable$14,666 $9,070 
Accrued liabilities5,962 6,520 
Accrued compensation and benefits12,994 15,495 
Operating lease liabilities, current portion1,971 1,562 
Other current liabilities— 32,600 
Total current liabilities35,593 65,247 
Operating lease liabilities, net of current portion876 7,555 
Deferred tax liabilities, net13,658 16,412 
Total liabilities50,127 89,214 
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, 2023 and December 31, 2022— — 
Common stock, par value $0.0001, 75,000,000 shares authorized at September 30, 2023 and December 31, 2022; 50,669,203 and 49,546,727 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively5 5 
Additional paid-in capital1,022,052 969,545 
Accumulated deficit(386,926)(374,264)
Accumulated other comprehensive loss(24,511)(25,147)
Total stockholders’ equity610,620 570,139 
Total liabilities and stockholders’ equity$660,747 $659,353 


Axonics, Inc.
Consolidated Statements of Comprehensive Loss
(in thousands, except share and per share data)
(unaudited)
Three Months Ended
September 30,		Nine Months Ended
September 30,
2023202220232022
Net revenue$93,100 $70,384 $256,644 $187,784 
Cost of goods sold23,996 19,124 64,850 53,086 
Gross profit69,104 51,260 191,794 134,698 
Operating expenses
Research and development8,167 7,936 25,172 26,307 
General and administrative11,778 9,389 34,659 29,974 
Sales and marketing47,544 39,751 134,468 112,195 
Amortization of intangible assets2,302 2,317 6,803 7,112 
Acquisition-related costs— 8,242 2,368 20,447 
Acquired in-process research & development— — 15,447 — 
Total operating expenses69,791 67,635 218,917 196,035 
Loss from operations(687)(16,375)(27,123)(61,337)
Other income (expense)
Interest and other income4,271 1,501 12,149 1,904 
Interest and other expense(83)(1,898)774 (3,026)
Other income (expense), net4,188 (397)12,923 (1,122)
Income (loss) before income tax benefit3,501 (16,772)(14,200)(62,459)
Income tax benefit(427)(520)(1,538)(2,096)
Net income (loss)3,928 (16,252)(12,662)(60,363)
Foreign currency translation adjustment(6,185)(12,057)636 (29,625)
Comprehensive loss$(2,257)$(28,309)$(12,026)$(89,988)
Net income (loss) per share, basic$0.08 $(0.34)$(0.26)$(1.31)
Weighted-average shares used to compute basic net income (loss) per share49,244,981 47,208,192 48,973,252 46,185,209 
Net income (loss) per share, diluted$0.08 $(0.34)$(0.26)$(1.31)
Weighted-average shares used to compute diluted net income (loss) per share50,086,491 47,208,192 48,973,252 46,185,209 


Axonics, Inc.
Net Revenue by Product and Region
(in thousands)
(unaudited)
Three Months Ended
September 30,		Nine Months Ended
September 30,
2023202220232022
Sacral neuromodulation
United States$72,212 $55,610 $198,270 $147,793 
International1,737 1,249 5,025 3,894 
Sacral neuromodulation total$73,949 $56,859 $203,295 $151,687 
Bulkamid
United States$15,579 $11,045 $41,998 $27,837 
International3,572 2,480 11,351 8,260 
Bulkamid total$19,151 $13,525 $53,349 $36,097 
Total net revenue$93,100 $70,384 $256,644 $187,784 

Axonics, Inc.
Reconciliation of GAAP Net Income (Loss) to Adjusted EBITDA
(in thousands)
(unaudited)
Three Months Ended
September 30,		Nine Months Ended
September 30,
2023202220232022
GAAP Net income (loss)$3,928 $(16,252)$(12,662)$(60,363)
Non-GAAP Adjustments:
Interest and other income(4,271)(1,501)(12,149)(1,904)
Interest and other expense83 1,898 (774)3,026 
Income tax benefit(427)(520)(1,538)(2,096)
Depreciation and amortization expense3,254 2,921 9,295 8,841 
Stock-based compensation expense11,470 8,218 33,388 23,261 
Acquisition-related costs— 8,242 2,368 20,447 
Acquired in-process research & development— — 15,447 — 
Impairment expense— 287 — 287 
Adjusted EBITDA$14,037 $3,293 $33,375 $(8,501)

v3.23.3
Cover Page
Oct. 30, 2023
Cover [Abstract]  
Amendment Flag false
Entity Central Index Key 0001603756
Document Type 8-K
Document Period End Date Oct. 30, 2023
Entity Registrant Name Axonics, Inc.
Entity Incorporation, State or Country Code DE
Entity File Number 001-38721
Entity Tax Identification Number 45-4744083
Entity Address, Address Line One 26 Technology Drive
Entity Address, City or Town Irvine
Entity Address, State or Province CA
Entity Address, Postal Zip Code 92618
City Area Code 949
Local Phone Number 396-6322
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Entity Emerging Growth Company false
Title of 12(b) Security Common stock, par value $0.0001 per share
Trading Symbol AXNX
Security Exchange Name NASDAQ
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