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): November 4, 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 November 4, 2021, Axonics, Inc. (the Company) issued a press release announcing its financial results for the quarter ended September 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: November 4, 2021
| ||By:|| ||/s/ Raymond W. Cohen|
| || ||Raymond W. Cohen|
| || ||Chief Executive Officer|
Axonics® Reports Third Quarter 2021 Financial Results
IRVINE, Calif – November 4, 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 third quarter ended September 30, 2021.
“We are pleased with this quarter’s revenue result considering the significant impact the surge in Covid-19 Delta variant cases had on elective procedure volumes in August and September, in addition to staffing shortages at hospitals and seasonality from summer vacations,” said Raymond W. Cohen, chief executive officer of Axonics. “Bulkamid® posted its highest revenue quarter to date and has proven to be more insulated from Covid-19 impact due to physicians having the option to perform the procedure in their offices.”
Cohen continued, “Over the last four months, we have had the pleasure of hosting 325 physicians at six regional seminars to introduce Bulkamid and provide proctored wet lab training. The programs also provided us with an opportunity to introduce our sacral neuromodulation system to physicians who are less familiar with Axonics and have them hear firsthand from their peers who have already experienced the difference of working with Axonics. The overwhelmingly positive feedback from physicians at these seminars reinforces our confidence that the SNM market will grow considerably once Covid-19 subsides and that Axonics’ best-in-class incontinence solutions will drive durable growth for years to come.”
Third Quarter 2021 Financial Results
•Net revenue was $46.9 million in third quarter 2021, an increase of 33% compared to $35.2 million in the prior year period.
◦Sacral neuromodulation (SNM) revenue was $40.1 million, of which $39.1 million was generated in the U.S. and the remainder in select international markets.
◦Bulkamid revenue was $6.8 million, of which $3.9 million was generated in the U.S. and the remainder in international markets.
•Gross margin was 66.5% in third quarter 2021 compared to 61.9% in the prior year period.
•Operating expenses were $47.7 million in third quarter 2021 compared to $30.6 million in the prior year period.
•Net loss was $17.3 million in third quarter 2021 compared to a net loss of $9.2 million in the prior year period.
•As of September 30, 2021, cash and cash equivalents were $228.8 million.
2021 Revenue Guidance
Axonics continues to closely monitor the impact that the Covid-19 pandemic has had, and continues to have, on elective procedure volumes. Based on third quarter results as well as continuing disruptions from Covid-19 and hospital staffing shortages potentially slowing the recovery in elective procedure volumes, Axonics is updating its 2021 guidance as follows:
•Fiscal year 2021 total company revenue of $177.0 million, an increase of 59% compared to fiscal year 2020.
◦4Q21 total company revenue of $49.8 million, an increase of 43% compared to 4Q20.
•Fiscal year 2021 SNM revenue of $155.2 million, an increase of 39% compared to fiscal year 2020.
◦4Q21 SNM revenue of $42.0 million, an increase of 21% compared to 4Q20.
•Fiscal year 2021 Bulkamid revenue of $21.8 million.
◦4Q21 Bulkamid revenue of $7.8 million.
Webcast and Conference Call
Axonics will host a conference call today, November 4, 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 8798817.
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 adults with 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 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 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 Balance Sheets
(in thousands, except share and per share data)
|September 30,||December 31,|
|Cash and cash equivalents||$||228,797 ||$||241,181 |
|Accounts receivable, net of allowance for doubtful accounts of $385 and $465 at September 30, 2021 and December 31, 2020, respectively||26,641 ||18,270 |
|Inventory, net||70,358 ||63,060 |
|Prepaid expenses and other current assets||4,433 ||5,435 |
|Total current assets||330,229 ||327,946 |
|Property and equipment, net||6,168 ||6,328 |
|Intangible assets, net||108,302 ||196 |
|Other assets||7,041 ||7,736 |
|Goodwill||109,565 ||— |
|Total assets||$||561,305 ||$||342,206 |
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accounts payable||$||10,512 ||$||10,660 |
|Accrued liabilities||6,424 ||6,684 |
|Accrued compensation and benefits||9,305 ||5,948 |
|Operating lease liability, current portion||1,401 ||1,280 |
|Debt, net of unamortized debt issuance costs, current portion||109 ||21,110 |
|Total current liabilities||27,751 ||45,682 |
|Operating lease liability, net of current portion||8,152 ||9,154 |
|Deferred tax liabilities, net||26,432 ||— |
|Other long-term liabilities||8,880 ||— |
|Total liabilities||71,215 ||54,836 |
|Preferred stock, par value $0.0001 per share; 10,000,000 shares authorized, no shares issued and outstanding at September 30, 2021 and December 31, 2020||— ||— |
|Common stock, par value $0.0001, 50,000,000 shares authorized at September 30, 2021 and December 31, 2020; 46,258,758 and 39,931,030 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively||5 ||4 |
|Additional paid-in capital||796,397 ||522,296 |
|Accumulated other comprehensive loss||(6,912)||(431)|
|Total stockholders’ equity||490,090 ||287,370 |
|Total liabilities and stockholders’ equity||$||561,305 ||$||342,206 |
Condensed Consolidated Statements of Comprehensive Loss
(in thousands, except share and per share data)
|Three Months Ended|
|Nine Months Ended|
|Net revenue||$||46,913 ||$||35,243 ||$||127,155 ||$||76,752 |
|Cost of goods sold||15,719 ||13,434 ||46,828 ||31,792 |
|Gross profit||31,194 ||21,809 ||80,327 ||44,960 |
|Research and development||8,648 ||7,719 ||27,115 ||20,944 |
|General and administrative||8,720 ||5,773 ||23,381 ||18,963 |
|Sales and marketing||28,112 ||17,057 ||74,451 ||47,846 |
|Amortization of intangible assets||2,216 ||29 ||5,094 ||86 |
|Acquisition-related costs||— ||— ||4,414 ||— |
|Total operating expenses||47,696 ||30,578 ||134,455 ||87,839 |
|Loss from operations||(16,502)||(8,769)||(54,128)||(42,879)|
|Interest income||9 ||35 ||24 ||742 |
|Interest and other expense||(229)||(434)||(7,528)||(1,429)|
|Other expense, net||(220)||(399)||(7,504)||(687)|
|Loss before income tax expense||(16,722)||(9,168)||(61,632)||(43,566)|
|Income tax expense||528 ||— ||3,269 ||1 |
|Foreign currency translation adjustment||(5,138)||99 ||(6,481)||(186)|
|Net loss per share, basic and diluted||$||(0.38)||$||(0.24)||$||(1.53)||$||(1.20)|
|Weighted-average shares used to compute basic and diluted net loss per share||44,848,023 ||38,830,924 ||42,436,061 ||36,312,984 |
Net Revenue Growth by Product and Geographic Region
(in thousands, except percentages)
|Three Months Ended|
|Nine Months Ended|
|2021||2020||% Change||2021||2020||% Change|
|United States||$||39,147 ||$||34,139 ||14.7%||$||110,135 ||$||73,833 ||49.2%|
|International||922 ||1,104 ||(16.5)%||3,031 ||2,919 ||3.8%|
|SNM Total||$||40,069 ||$||35,243 ||13.7%||$||113,166 ||$||76,752 ||47.4%|
|United States||$||3,921 ||$||— ||N/A||$||6,870 ||$||— ||N/A|
|International||2,923 ||— ||N/A||7,119 ||— ||N/A|
|Bulkamid Total||$||6,844 ||$||— ||N/A||$||13,989 ||$||— ||N/A|
|Total net revenue||$||46,913 ||$||35,243 ||33.1%||$||127,155 ||$||76,752 ||65.7%|