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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): November 14, 2019
_________________________________________________________________
Axonics Modulation Technologies, 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:
 
o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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
ý
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.  ý
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
 




Item 2.02.    Results of Operations and Financial Condition.
On November 14, 2019, Axonics Modulation Technologies, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2019. 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 (the “Exchange Act”), 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, or the Exchange Act, 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
 




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 MODULATION TECHNOLOGIES, INC.
 
 
 
Date: November 14, 2019
 
By:
 
/s/ Raymond W. Cohen
 
 
 
 
Raymond W. Cohen
 
 
 
 
Chief Executive Officer


Exhibit
Exhibit 99.1
Axonics® Announces Third Quarter 2019 Financial Results and Operational Update

IRVINE, CA – November 14, 2019 – Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing novel implantable Sacral Neuromodulation (“SNM”) devices for the treatment of urinary and bowel dysfunction, reported today financial results for the third quarter ended September 30, 2019, and provided an update on operational initiatives.
Recent Business Highlights
•
Net sales of the Axonics r-SNM® System from international markets totaled $1.3 million in the third quarter of 2019 as compared to $0.2 million in revenue in the same period last year.
•
Sales in the third quarter were derived primarily from England and the Netherlands along with three hospitals in Germany and three hospitals in Switzerland ordering in the quarter. A total of 32 hospitals in these markets are now implanting the Axonics r-SNM System.
•
The first commercial patient was implanted in the United States at the University of California, Irvine on October 29 followed by a few dozen implants primarily for patients with bowel or dual incontinence in the first weeks following the commencement of sales in the U.S.
•
During October and November, physician seminars were completed in Orlando, Irvine, Dallas and Boston. These one-day Saturday seminars were attended by 273 U.S.-based SNM implanters. A fifth program has been added in early December to accommodate demand with 46 additional physicians currently registered.
•
On November 13, the U.S. Food and Drug Administration (“FDA”) approved the Axonics r-SNM® System for the clinical indication of overactive bladder (“OAB”) which includes urinary urge incontinence and urinary urge frequency as well as urinary retention.
Raymond W. Cohen, CEO of Axonics, commented, “We are satisfied with the results of the third quarter considering the fact that a significant number of our small, but growing customer base in Europe did not perform implants in August during the summer holiday season. While we will continue to add new customer accounts in Germany and Switzerland and look to increase implants in England to close out 2019, the Company is now focused on the launch of our product in the U.S. market.”
Cohen continued, “Given the attendance at our physician seminar series and enthusiastic response by the SNM implanting community to our product, we have made excellent strides towards establishing Axonics as a serious contender in sacral neuromodulation by bringing innovation and awareness to a therapy that has been underutilized. With respect to FDA approval for urinary clinical indications, we can now begin to communicate the outstanding clinical results of the Axonics r-SNM System. Survey results from the seminar attendees clearly indicate that these physicians place a high value on clinical results and state that when considering what product to offer their patients, efficacy is the single most important factor, followed by a long-lived device. Our 146-person U.S. field team is now able to directly and effectively deliver this message while providing the level of support required to convert customers to Axonics and retain them.”
Third Quarter 2019 Financial Results
•
Net revenue was $1.3 million in the third quarter ended September 30, 2019 as compared to net revenue of $0.2 million for the same period of last year.
•
Gross margin was 51.7%.


•
Operating expense was $25.7 million for the third quarter of 2019, as compared to $7.6 million in the prior-year quarter. This increase was primarily due to higher personnel costs for the U.S. commercial team and across the organization related to increased headcount to support the commercial launch of the Company’s r-SNM System in the U.S.
•
Net loss for the third quarter of 2019 was $25.0 million, as compared to $7.6 million in the prior-year quarter. Net loss per share was $0.89 per share.
•
As of September 30, 2019, cash, cash equivalents and short-term investments were $101.5 million.
Webcast and Conference Call
Today, on Wednesday November 14, 2019, at 4:30 p.m. Eastern Time, the Company will host a conference call with the investment community to discuss its financial results and recent business developments.
Interested parties may access the live call via telephone by dialing (866) 687-5771 (U.S.) or (409) 217-8725 (International) and using conference ID 4373989.
A live webcast of the call may be accessed by visiting the Events & Presentations page of the investors section of the Company’s website at ir.axonicsmodulation.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the Company’s website for 90 days.
About Axonics Modulation Technologies, Inc.
Axonics, based in Irvine, Calif., has developed and is commercializing novel implantable SNM devices for patients with urinary and bowel dysfunction. These conditions are caused by a miscommunication between the bladder and the brain and significantly impacts quality of life. Overactive bladder affects an estimated 87 million adults in the U.S. and Europe. Another estimated 40 million adults are reported to suffer from fecal incontinence/accidental bowel leakage. SNM therapy has been employed to reduce symptoms and restore pelvic floor function for the past two decades. Reimbursement coverage is well established in the U.S. and Europe. The Axonics System is the first rechargeable SNM system approved for sale in the world, and the first to gain full-body MRI conditional labeling. For more information, visit the Company’s website at 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 “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.

Contacts:
Axonics’ Contact
Axonics Modulation Technologies, Inc.
Dan Dearen, +1-949-396-6320
President & Chief Financial Officer
ir@axonics.com


Investor & Media Contact
W2Opure
Matt Clawson, +1-949-370-8500
mclawson@w2ogroup.com


Axonics Modulation Technologies, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
 
September 30,
 
December 31,
 
2019
 
2018
 
(unaudited)
 
 
ASSETS
 
 
 
Current assets
 
 
 
Cash and cash equivalents
$
76,231

 
$
98,306

Short-term investments
25,311

 
59,218

Accounts receivable
954

 
427

Inventory, net
12,703

 
3,673

Prepaid expenses and other current assets
2,625

 
3,716

Total current assets
117,824

 
165,340

Property and equipment, net
2,952

 
2,784

Intangible asset, net
340

 
426

Other assets
4,928

 
3,356

Total assets
$
126,044

 
$
171,906

 
 
 
 
LIABILITIES AND STOCKHOLDERS’ EQUITY
 
 
 
Current liabilities
 
 
 
Accounts payable
$
4,232

 
$
3,436

Accrued liabilities
4,304

 
1,683

Lease liability, current portion
625

 
768

Debt, net of unamortized debt issuance costs, current portion
6,382

 
—

Total current liabilities
15,543

 
5,887

Lease liability, net of current portion
4,573

 
3,281

Debt, net of unamortized debt issuance costs, net of current portion
13,740

 
19,463

Total liabilities
33,856

 
28,631

Stockholders’ equity
 
 
 
Preferred stock, par value $0.0001 per share; 10,000,000 shares authorized, no shares issued and outstanding at September 30, 2019 and December 31, 2018
—

 
—

Common stock, par value $0.0001, 50,000,000 shares authorized at September 30, 2019 and December 31, 2018; 28,633,911 and 27,806,934 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively
3

 
3

Additional paid-in capital
249,599

 
243,337

Accumulated deficit
(156,833
)
 
(99,649
)
Accumulated other comprehensive loss
(581
)
 
(416
)
Total stockholders’ equity
92,188

 
143,275

Total liabilities and stockholders’ equity
$
126,044

 
$
171,906



Axonics Modulation Technologies, Inc.
Condensed Consolidated Statements of Comprehensive Loss
(in thousands, except share and per share data)
(unaudited)
 
Three Months Ended
September 30,
 
Nine Months Ended
September 30,
 
2019
 
2018
 
2019
 
2018
Net revenue
$
1,309

 
$
201

 
$
3,874

 
$
213

Cost of goods sold
632

 
106

 
1,952

 
111

Gross profit
677

 
95

 
1,922

 
102

Operating Expenses
 
 
 
 
 
 
 
Research and development
4,855

 
3,898

 
13,948

 
14,619

General and administrative
5,162

 
2,790

 
13,539

 
5,861

Sales and marketing
15,707

 
949

 
32,371

 
2,308

Total operating expenses
25,724

 
7,637

 
59,858

 
22,788

Loss from operations
(25,047
)
 
(7,542
)
 
(57,936
)
 
(22,686
)
Other Income (Expense)
 
 
 
 
 
 
 
Interest income
627

 
172

 
2,500

 
448

Interest and other expense
(586
)
 
(196
)
 
(1,747
)
 
(579
)
Other income (expense), net
41

 
(24
)
 
753

 
(131
)
Loss before income tax expense
(25,006
)
 
(7,566
)
 
(57,183
)
 
(22,817
)
Income tax expense
—

 
—

 
1

 
1

Net loss
(25,006
)
 
(7,566
)
 
(57,184
)
 
(22,818
)
Foreign currency translation adjustment
(112
)
 
(1
)
 
(165
)
 
(4
)
Comprehensive loss
$
(25,118
)
 
$
(7,567
)
 
$
(57,349
)
 
$
(22,822
)
 
 
 
 
 
 
 
 
Net loss per share, basic and diluted
$
(0.89
)
 
$
(2.67
)
 
$
(2.05
)
 
$
(8.10
)
Weighted-average shares used to compute basic and diluted net loss per share
28,098,564

 
2,830,591

 
27,958,376

 
2,817,652