false000160375600016037562024-08-012024-08-01

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): August 1, 2024
_________________________________________________________________
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 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 August 1, 2024, Axonics, Inc. (the Company) issued a press release announcing its financial results for the quarter ended June 30, 2024. 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: August 1, 2024
 By: /s/ Raymond W. Cohen
  Raymond W. Cohen
  Chief Executive Officer


Exhibit 99.1
Axonics Reports Second Quarter 2024 Financial Results
Generated record revenue, gross margin and net income in 2Q24

IRVINE, Calif. – August 1, 2024 – Axonics, Inc. (Nasdaq: AXNX), a medical technology company that develops, manufactures and commercializes innovative and minimally invasive products to treat bladder and bowel dysfunction, today reported financial results for the three months ended June 30, 2024.

“Axonics continued to execute at a high level in the second quarter, generating record revenue and setting new high-water marks for gross margin and adjusted EBITDA margin,” said Raymond W. Cohen, chief executive officer. “Revenue growth of 23% year over year was driven by higher utilization at existing customers and the onboarding of new accounts. Axonics also generated record net income in the second quarter, a result of gross margin expansion from higher manufacturing yields and continued operating leverage.”

Mr. Cohen continued, “We remain confident that our commitment to innovation, quality, direct-to-consumer advertising and providing strong clinical support will continue to expand the sacral neuromodulation market and propel Axonics on its path to market leadership. We look forward to the global impact the Axonics portfolio of life-changing incontinence therapies can make as part of Boston Scientific as we endeavor to treat more patients than ever before.”

Second Quarter 2024 Financial Results
•Net revenue was $114.6 million, an increase of 23% compared to the prior year period.
◦Sacral neuromodulation revenue was $91.2 million, an increase of 23% compared to the prior year period.
◦Bulkamid revenue was $23.4 million, an increase of 25% compared to the prior year period.
•Gross margin was 77.8% compared to 75.6% in the prior year period.
•Operating expenses were $85.5 million compared to $82.3 million in the prior year period.
•Net income was $6.9 million compared to a net loss of $7.3 million in the prior year period.
•Adjusted EBITDA was $23.4 million compared to $18.4 million in the prior year period.
•Cash, cash equivalents, short-term investments and restricted cash were $362 million as of June 30, 2024.
About Axonics
Axonics is a global medical technology company that is developing and commercializing novel products for adults with bladder and bowel dysfunction. Axonics 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 loss before other income/expense (including interest), income tax expense (benefit), depreciation and amortization expense, stock-based compensation expense, acquisition-related costs, cash compensation in lieu of equity compensation due to pending merger, 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 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.

Axonics contact:
Neil Bhalodkar
IR@axonics.com


Axonics, Inc.
Consolidated Balance Sheets
(in thousands, except share and per share data)
June 30,December 31,
20242023
(unaudited)
ASSETS
Current assets
Cash and cash equivalents$168,619 $104,811 
Short-term investments174,792 240,149 
Accounts receivable, net of allowance for credit losses of $1,111 and $442 at June 30, 2024 and December 31, 2023, respectively57,221 57,243 
Inventory, net105,428 79,940 
Prepaid expenses and other current assets6,003 9,279 
Total current assets512,063 491,422 
Restricted cash18,629 12,714 
Property and equipment, net18,382 10,760 
Intangible assets, net76,333 81,375 
Other assets23,183 24,235 
Goodwill98,747 99,417 
Total assets$747,337 $719,923 
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable$19,316 $18,452 
Accrued liabilities11,042 10,527 
Accrued compensation and benefits24,793 15,060 
Operating lease liabilities, current portion2,022 1,777 
Total current liabilities57,173 45,816 
Operating lease liabilities, net of current portion30,431 25,840 
Deferred tax liabilities, net16,417 10,703 
Total liabilities104,021 82,359 
Commitments and contingencies
Stockholders’ equity
Preferred stock, par value $0.0001 per share; 10,000,000 shares authorized, no shares issued and outstanding at June 30, 2024 and December 31, 2023— — 
Common stock, par value $0.0001, 75,000,000 shares authorized at June 30, 2024 and December 31, 2023; 51,014,562 and 50,770,520 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively5 5 
Additional paid-in capital1,052,429 1,033,778 
Accumulated deficit(392,565)(380,352)
Accumulated other comprehensive loss(16,553)(15,867)
Total stockholders’ equity643,316 637,564 
Total liabilities and stockholders’ equity$747,337 $719,923 


Axonics, Inc.
Consolidated Statements of Comprehensive Income (Loss)
(in thousands, except share and per share data)
(unaudited)
Three Months Ended
June 30,		Six Months Ended
June 30,
2024202320242023
Net revenue$114,565 $92,894 $205,974 $163,544 
Cost of goods sold25,422 22,704 47,578 40,854 
Gross profit89,143 70,190 158,396 122,690 
Operating expenses
Research and development12,792 8,949 23,848 17,005 
General and administrative16,327 10,713 31,431 22,881 
Sales and marketing51,444 44,270 107,635 86,924 
Amortization of intangible assets2,247 2,279 4,501 4,501 
Acquisition-related costs2,652 602 6,479 2,368 
Acquired in-process research & development— 15,447 — 15,447 
Total operating expenses85,462 82,260 173,894 149,126 
Income (loss) from operations3,681 (12,070)(15,498)(26,436)
Other income (expense)
Interest and other income4,702 4,250 8,675 7,878 
Interest and other expense(32)174 (91)857 
Other income, net4,670 4,424 8,584 8,735 
Income (loss) before income tax expense (benefit)8,351 (7,646)(6,914)(17,701)
Income tax expense (benefit)1,452 (304)5,299 (1,111)
Net income (loss)6,899 (7,342)(12,213)(16,590)
Foreign currency translation adjustment466 3,750 (686)6,821 
Comprehensive income (loss)$7,365 $(3,592)$(12,899)$(9,769)
Net income (loss) per share, basic$0.14 $(0.15)$(0.24)$(0.34)
Weighted-average shares used to compute basic net income (loss) per share50,010,380 49,088,373 50,971,867 48,835,135 
Net income (loss) per share, diluted$0.13 $(0.15)$(0.24)$(0.34)
Weighted-average shares used to compute diluted net income (loss) per share51,230,849 49,088,373 50,971,867 48,835,135 


Axonics, Inc.
Net Revenue by Product and Region
(in thousands)
(unaudited)
Three Months Ended
June 30,		Six Months Ended
June 30,
2024202320242023
Sacral neuromodulation
United States$89,076 $72,205 $158,916 $126,058 
International2,139 1,983 3,978 3,288 
Sacral neuromodulation total$91,215 $74,188 $162,894 $129,346 
Bulkamid
United States$18,306 $14,806 $33,525 $26,419 
International5,044 3,900 9,555 7,779 
Bulkamid total$23,350 $18,706 $43,080 $34,198 
Total net revenue$114,565 $92,894 $205,974 $163,544 

Axonics, Inc.
Reconciliation of GAAP Net Income (Loss) to Adjusted EBITDA
(in thousands)
(unaudited)
Three Months Ended
June 30,		Six Months Ended
June 30,
2024202320242023
GAAP Net income (loss)$6,899 $(7,342)$(12,213)$(16,590)
Non-GAAP Adjustments:
Interest and other income(4,702)(4,250)(8,675)(7,878)
Interest and other expense32 (174)91 (857)
Income tax expense (benefit)1,452 (304)5,299 (1,111)
Depreciation and amortization expense2,901 3,228 6,083 6,041 
Stock-based compensation expense8,611 11,204 18,162 21,918 
Acquisition-related costs2,652 602 6,479 2,368 
Cash compensation in lieu of equity compensation due to pending merger5,591 — 11,182 — 
Acquired in-process research & development— 15,447 — 15,447 
Adjusted EBITDA$23,436 $18,411 $26,408 $19,338 

v3.24.2.u1
Cover Page
Aug. 01, 2024
Cover [Abstract]  
Amendment Flag false
Entity Central Index Key 0001603756
Document Type 8-K
Document Period End Date Aug. 01, 2024
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
Axonics (NASDAQ:AXNX)
Historical Stock Chart
From Jul 2024 to Aug 2024 Click Here for more Axonics Charts.
Axonics (NASDAQ:AXNX)
Historical Stock Chart
From Aug 2023 to Aug 2024 Click Here for more Axonics Charts.