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): April 30, 2024
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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 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 April 30, 2024, Axonics, Inc. (the Company) issued a press release announcing its financial results for the quarter ended March 31, 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 | Press release of Axonics, Inc., dated April 30, 2024 | |||||||
| 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: April 30, 2024 | By: | /s/ Raymond W. Cohen | ||||||||||||
| Raymond W. Cohen | ||||||||||||||
| Chief Executive Officer | ||||||||||||||
Exhibit 99.1
Axonics Reports First Quarter 2024 Financial Results
IRVINE, Calif. – April 30, 2024 – Axonics, Inc. (Nasdaq: AXNX), a medical technology company that develops and commercializes innovative and minimally invasive products to treat bladder and bowel dysfunction, today reported financial results for the three months ended March 31, 2024.
“Our commercial team continued to execute at a high level in the first quarter, generating revenue growth of 29% year over year across our portfolio of incontinence products,” said Raymond W. Cohen, chief executive officer. “Our growth was driven by higher utilization and share of wallet for existing sacral neuromodulation customers and the onboarding of new accounts. In addition, gross margin expanded to 75.8%, a new record, as we benefited from higher yields that were achieved through the diligent efforts of our manufacturing and operations team in Irvine.”
Mr. Cohen continued, “We remain confident that our commitment to innovation, quality, direct-to-consumer advertising and providing strong clinical support will continue to drive market expansion. We look forward to the global impact we can make as part of Boston Scientific as we endeavor to bring our life-changing incontinence therapies to more patients than ever before.”
First Quarter 2024 Financial Results
•Net revenue was $91.4 million, an increase of 29% compared to the prior year period.
◦Sacral neuromodulation revenue was $71.7 million, an increase of 30% compared to the prior year period.
◦Bulkamid revenue was $19.7 million, an increase of 27% compared to the prior year period.
•Gross margin was 75.8% compared to 74.3% in the prior year period.
•Operating expenses were $88.4 million and included $3.8 million of acquisition-related costs related to the Boston Scientific merger. Operating expenses were $66.9 million in the prior year period and included $1.8 million of acquisition-related costs.
•Net loss was $19.1 million compared to a net loss of $9.2 million in the prior year period.
•Adjusted EBITDA was $3.0 million compared to $0.9 million in the prior year period.
◦Due to the pending merger with Boston Scientific, Axonics stopped issuing new equity grants to employees as of January 2024. In 1Q24, approximately $6 million of compensation expense, as previously disclosed in Schedule 14A on January 8, 2024, that would normally have been issued as equity compensation shifted to cash compensation and is added back to adjusted EBITDA.
•Cash, cash equivalents, short-term investments and restricted cash were $349 million as of March 31, 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 recently 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
Neil Bhalodkar
IR@axonics.com
Axonics, Inc.
Consolidated Balance Sheets
(in thousands, except share and per share data)
| March 31, | December 31, | ||||||||||
| 2024 | 2023 | ||||||||||
| (unaudited) | |||||||||||
| ASSETS | |||||||||||
| Current assets | |||||||||||
| Cash and cash equivalents | $ | 232,645 | $ | 104,811 | |||||||
| Short-term investments | 100,161 | 240,149 | |||||||||
| Accounts receivable, net of allowance for credit losses of $1,079 and $442 at March 31, 2024 and December 31, 2023, respectively | 50,529 | 57,243 | |||||||||
| Inventory, net | 93,187 | 79,940 | |||||||||
| Prepaid expenses and other current assets | 5,508 | 9,279 | |||||||||
| Total current assets | 482,030 | 491,422 | |||||||||
| Restricted cash | 15,826 | 12,714 | |||||||||
| Property and equipment, net | 17,037 | 10,760 | |||||||||
| Intangible assets, net | 78,422 | 81,375 | |||||||||
| Other assets | 23,703 | 24,235 | |||||||||
| Goodwill | 98,543 | 99,417 | |||||||||
| Total assets | $ | 715,561 | $ | 719,923 | |||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||||
| Current liabilities | |||||||||||
| Accounts payable | $ | 15,770 | $ | 18,452 | |||||||
| Accrued liabilities | 14,752 | 10,527 | |||||||||
| Accrued compensation and benefits | 16,409 | 15,060 | |||||||||
| Operating lease liabilities, current portion | 1,456 | 1,777 | |||||||||
| Total current liabilities | 48,387 | 45,816 | |||||||||
| Operating lease liabilities, net of current portion | 30,154 | 25,840 | |||||||||
| Deferred tax liabilities, net | 9,921 | 10,703 | |||||||||
| Total liabilities | 88,462 | 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 March 31, 2024 and December 31, 2023 | — | — | |||||||||
| Common stock, par value $0.0001, 75,000,000 shares authorized at March 31, 2024 and December 31, 2023; 51,018,179 and 50,770,520 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively | 5 | 5 | |||||||||
| Additional paid-in capital | 1,043,577 | 1,033,778 | |||||||||
| Accumulated deficit | (399,464) | (380,352) | |||||||||
| Accumulated other comprehensive loss | (17,019) | (15,867) | |||||||||
| Total stockholders’ equity | 627,099 | 637,564 | |||||||||
| Total liabilities and stockholders’ equity | $ | 715,561 | $ | 719,923 | |||||||
Axonics, Inc.
Consolidated Statements of Comprehensive Loss
(in thousands, except share and per share data)
(unaudited)
| Three Months Ended March 31, | |||||||||||
| 2024 | 2023 | ||||||||||
| Net revenue | $ | 91,409 | $ | 70,650 | |||||||
| Cost of goods sold | 22,156 | 18,150 | |||||||||
| Gross profit | 69,253 | 52,500 | |||||||||
| Operating expenses | |||||||||||
| Research and development | 11,056 | 8,056 | |||||||||
| General and administrative | 15,104 | 12,168 | |||||||||
| Sales and marketing | 56,191 | 42,654 | |||||||||
| Amortization of intangible assets | 2,254 | 2,222 | |||||||||
| Acquisition-related costs | 3,827 | 1,766 | |||||||||
| Total operating expenses | 88,432 | 66,866 | |||||||||
| Loss from operations | (19,179) | (14,366) | |||||||||
| Other income (expense) | |||||||||||
| Interest and other income | 3,973 | 3,628 | |||||||||
| Interest and other expense | (59) | 683 | |||||||||
| Other income, net | 3,914 | 4,311 | |||||||||
| Loss before income tax expense (benefit) | (15,265) | (10,055) | |||||||||
| Income tax expense (benefit) | 3,847 | (807) | |||||||||
| Net loss | (19,112) | (9,248) | |||||||||
| Foreign currency translation adjustment | (1,152) | 3,071 | |||||||||
| Comprehensive loss | $ | (20,264) | $ | (6,177) | |||||||
| Net loss per share, basic and diluted | $ | (0.38) | $ | (0.19) | |||||||
| Weighted-average shares used to compute basic and diluted net loss per share | 50,928,171 | 48,579,084 | |||||||||
Axonics, Inc.
Net Revenue by Product and Region
(in thousands)
(unaudited)
| Three Months Ended March 31, | |||||||||||
| 2024 | 2023 | ||||||||||
| Sacral neuromodulation | |||||||||||
| United States | $ | 69,840 | $ | 53,853 | |||||||
| International | 1,839 | 1,305 | |||||||||
| Sacral neuromodulation total | $ | 71,679 | $ | 55,158 | |||||||
| Bulkamid | |||||||||||
| United States | $ | 15,219 | $ | 11,613 | |||||||
| International | 4,511 | 3,879 | |||||||||
| Bulkamid total | $ | 19,730 | $ | 15,492 | |||||||
| Total net revenue | $ | 91,409 | $ | 70,650 | |||||||
Axonics, Inc.
Reconciliation of GAAP Net Loss to Adjusted EBITDA
(in thousands)
(unaudited)
| Three Months Ended March 31, | |||||||||||
| 2024 | 2023 | ||||||||||
| GAAP Net loss | $ | (19,112) | $ | (9,248) | |||||||
| Non-GAAP Adjustments: | |||||||||||
| Interest and other income | (3,973) | (3,628) | |||||||||
| Interest and other expense | 59 | (683) | |||||||||
| Income tax expense (benefit) | 3,847 | (807) | |||||||||
| Depreciation and amortization expense | 3,182 | 2,813 | |||||||||
| Stock-based compensation expense | 9,551 | 10,714 | |||||||||
| Acquisition-related costs | 3,827 | 1,766 | |||||||||
| Cash compensation in lieu of equity compensation due to pending merger | 5,591 | — | |||||||||
| Adjusted EBITDA | $ | 2,972 | $ | 927 | |||||||