SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 OR 15(d) of The
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 5, 2021
(Exact name of registrant as specified in its charter)
|Delaware|| ||001-38721|| ||45-4744083|
|(State or other jurisdiction|
| ||(Commission File Number)|| ||(I.R.S. Employer|
26 Technology Drive
Irvine, California 92618
(Address of principal executive offices) (Zip Code)
(Registrant’s telephone number, including area code)
(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 class||Trading symbol||Name of exchange on which registered|
|Common stock, par value $0.0001 per share||AXNX||Nasdaq 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).
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 5, 2021, Axonics, Inc. (the Company) issued a press release announcing its financial results for the quarter ended June 30, 2021. 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.
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 5, 2021|| ||By:|| ||/s/ Raymond W. Cohen|
| || ||Raymond W. Cohen|
| || ||Chief Executive Officer|
Axonics® Reports Second Quarter 2021 Financial Results
Total revenue of $45.9 million in 2Q21, including record SNM revenue of $40.2 million
Bulkamid® revenue of $5.7 million in first full quarter since acquisition
Fiscal year 2021 revenue guidance increased to a range of $186 million to $188 million
IRVINE, Calif – August 5, 2021 – 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 second quarter ended June 30, 2021.
“This quarter’s record revenue result reflects the growing demand for our best-in-class incontinence solutions,” said Raymond W. Cohen, chief executive officer of Axonics. “Clinical outcomes and satisfaction with our rechargeable sacral neuromodulation (SNM) system remain high, with over 12,000 patients having been implanted since our U.S. commercial launch in late 2019. Given the strong commercial momentum for both SNM and Bulkamid, we have increased our fiscal year 2021 revenue guidance to be in the range of $186 million to $188 million.”
Cohen continued, “During the second quarter, we trained our entire U.S. field team on Bulkamid and are now executing a broad rollout to physicians across the United States. Physician enthusiasm to incorporate this next-generation bulking agent into their practices to treat female stress urinary incontinence is significant as evidenced by our second quarter results and the six fully booked regional seminars we are hosting this summer to provide Bulkamid wet-lab training. In late June, we filed a PMA supplement with the FDA for our new long-lived, non-rechargeable implantable neurostimulator. We anticipate the 10-year life and fully recharge-free system will be a very attractive proposition for patients and physicians. The progress on these key initiatives and the continued expansion of our U.S. commercial team gives us confidence in achieving our ambitious long-term growth objectives.”
Second Quarter 2021 Financial Results
•Net revenue was $45.9 million in the second quarter 2021, an increase of 202% compared to $15.2 million in the prior year period.
◦Sacral neuromodulation revenue was $40.2 million, of which $39.2 million was generated in the U.S. and the remainder in select international markets.
◦Bulkamid revenue was $5.7 million, of which $2.4 million was generated in the U.S. and the remainder in international markets.
•Gross margin was 62.6% in the second quarter 2021 compared to 44.4% in the prior year period.
•Operating expenses were $44.7 million in the second quarter 2021 compared to $26.2 million in the prior year period.
•Net loss was $25.1 million in the second quarter 2021 compared to a net loss of $19.8 million in the prior year period.
•As of June 30, 2021, cash and cash equivalents were $231.1 million. In mid-June, Axonics prepaid and terminated its $75 million term loan with Silicon Valley Bank.
Second Quarter 2021 Corporate Highlights
•On May 14, 2021, Axonics completed a public stock offering of 4,025,000 shares at $50 per share, generating gross proceeds of $201.3 million.
•On May 18, 2021, Axonics announced CE Mark approval for its second generation rechargeable INS and wireless patient remote control with SmartMRI™ technology.
•On May 20, 2021, Axonics announced FDA approval allowing the use of detachable extremity coils for patients undergoing 1.5T and 3.0T MRI scans.
•On June 24, 2021, Axonics announced the filing of a PMA supplement with the FDA for its non-rechargeable INS.
Fiscal Year 2021 Revenue Guidance
Axonics is increasing its fiscal year 2021 revenue guidance as follows:
•Total net revenue to be in the range of $186 million to $188 million, representing growth of approximately 67% to 69% over fiscal year 2020 net revenue of $111.5 million. This compares to the prior net revenue outlook of $176 million to $180 million.
•Sacral neuromodulation (SNM) net revenue to be in the range of $166 million to $168 million.
•Bulkamid net revenue of $20 million.
Webcast and Conference Call
Axonics will host a conference call today, August 5, 2021, 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 3072186.
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.
Based in Irvine, Calif., Axonics is a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction. The company’s rechargeable sacral neuromodulation (SNM) system provides patients suffering from overactive bladder and/or fecal incontinence with long-lived, easy to use, safe, clinically effective therapy. In addition, Axonics’ best-in-class urethral bulking agent, Bulkamid®, provides women suffering from stress urinary incontinence (SUI) with safe and durable symptom relief.
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 20 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.
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.
Condensed Consolidated Statements of Comprehensive Loss
(in thousands, except share and per share data)
|Three Months Ended|
|Six Months Ended|
|Sacral neuromodulation net revenue||$||40,194 ||$||15,213 ||$||73,097 ||$||41,509 |
|Bulkamid net revenue||5,675 ||— ||7,145 ||— |
|Total net revenue||45,869 ||15,213 ||80,242 ||41,509 |
|Cost of goods sold||17,135 ||8,463 ||31,109 ||18,358 |
|Gross profit||28,734 ||6,750 ||49,133 ||23,151 |
|Research and development||9,098 ||6,370 ||18,467 ||13,225 |
|General and administrative||8,035 ||5,537 ||14,661 ||13,190 |
|Sales and marketing||25,411 ||14,220 ||46,339 ||30,789 |
|Amortization of intangible assets||2,200 ||28 ||2,878 ||57 |
|Acquisition-related costs||— ||— ||4,414 ||— |
|Total operating expenses||44,744 ||26,155 ||86,759 ||57,261 |
|Loss from operations||(16,010)||(19,405)||(37,626)||(34,110)|
|Other Income (Expense)|
|Interest income||7 ||65 ||15 ||707 |
|Interest and other expense||(5,849)||(443)||(7,299)||(995)|
|Other expense, net||(5,842)||(378)||(7,284)||(288)|
|Loss before income tax expense||(21,852)||(19,783)||(44,910)||(34,398)|
|Income tax expense||3,296 ||— ||2,741 ||1 |
|Foreign currency translation adjustment||859 ||(108)||(1,343)||(285)|
|Net loss per share, basic and diluted||$||(0.59)||$||(0.54)||$||(1.16)||$||(0.98)|
|Weighted-average shares used to compute basic and diluted net loss per share||42,788,678 ||36,440,846 ||41,210,091 ||35,040,180 |
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
|June 30,||December 31,|
|Cash and cash equivalents||$||231,140 ||$||241,181 |
|Accounts receivable, net of allowance for doubtful accounts of $385 and $465 at June 30, 2021 and December 31, 2020, respectively||25,646 ||18,270 |
|Inventory, net||70,391 ||63,060 |
|Prepaid expenses and other current assets||5,006 ||5,435 |
|Total current assets||332,183 ||327,946 |
|Property and equipment, net||5,958 ||6,328 |
|Intangible assets, net||113,416 ||196 |
|Other assets||7,324 ||7,736 |
|Goodwill||106,631 ||— |
|Total assets||$||565,512 ||$||342,206 |
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accounts payable||$||9,447 ||$||10,660 |
|Accrued liabilities||6,305 ||6,684 |
|Accrued compensation and benefits||7,198 ||5,948 |
|Operating lease liability, current portion||1,407 ||1,280 |
|Debt, net of unamortized debt issuance costs, current portion||30 ||21,110 |
|Total current liabilities||24,387 ||45,682 |
|Operating lease liability, net of current portion||8,481 ||9,154 |
|Debt, net of unamortized debt issuance costs, net of current portion||89 ||— |
|Deferred tax liabilities, net||20,626 ||— |
|Other long-term liabilities||7,664 ||— |
|Total liabilities||61,247 ||54,836 |
|Preferred stock, par value $0.0001 per share; 10,000,000 shares authorized, no shares issued and outstanding at June 30, 2021 and December 31, 2020||— ||— |
|Common stock, par value $0.0001, 50,000,000 shares authorized at June 30, 2021 and December 31, 2020; 46,090,964 and 39,931,030 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively||5 ||4 |
|Additional paid-in capital||788,184 ||522,296 |
|Accumulated other comprehensive loss||(1,774)||(431)|
|Total stockholders’ equity||504,265 ||287,370 |
|Total liabilities and stockholders’ equity||$||565,512 ||$||342,206 |