Axonics Announces Third Quarter 2018 Financial Results and Operational Update
Business Wire 11-Dec-2018 4:00 PM
Axonics Modulation Technologies, Inc. (NASDAQ:AXNX) a medical
technology company focused on the development and commercialization of
novel implantable Sacral Neuromodulation ("SNM") devices for the
treatment of urinary
and bowel dysfunction, reported today financial results for the
quarter ended September 30, 2018 and provided an update on operational
initiatives.
Recent Business Highlights
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On November 2, completed the initial public offering of Axonics common
stock, receiving net proceeds of approximately $126.3 million after
deducting underwriting discounts, commissions and offering expenses.
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On November 29, announced its r-SNM® System was listed on the U.K.'s
National Health Service ("NHS") Supply Chain online catalogue.
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On December 3, submitted a literature-based premarket approval
application ("PMA") to the U.S. Food and Drug Administration ("FDA")
for the Axonics r-SNM System.
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On December 7, the FDA approved an Investigational Device Exemption
("IDE") supplement regarding the ARTISAN-SNM pivotal clinical study of
the Axonics r-SNM System. The ARTISAN-SNM clinical study is intended
to serve as primary clinical support for the Company's traditional PMA
filing. The supplement proposed, among other things, changing the
primary endpoint to an Intent to Treat ("ITT") analysis on all
implanted subjects. In addition, the FDA provided certain feedback
with respect to an early analysis of a partial cohort of subjects that
have reached their six-month post-implant time point.
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On December 10, announced the U.K.'s National Institute for Health and
Care Excellence ("NICE") published a Medtech Innovation Briefing on
the r-SNM System.
Raymond W. Cohen, CEO of Axonics commented, "First and foremost, we are
focused on concluding our ARTISAN-SNM pivotal clinical study where we
expect all subjects will reach their six-month post-implant endpoint in
early January 2019. Gaining FDA approval is the single most important
objective for Axonics and, as such, we are aggressively pursuing the
literature-based PMA and also continuing to gather clinical data using
our IDE study in order to obtain U.S. marketing approval in the shortest
possible timeframe."
Cohen continued, "We are also actively and carefully recruiting and
securing talented and experienced sales managers and sales field
professionals with approximately 30 of these individuals planning to
attend our first formal training program scheduled for mid-January 2019.
We have also been opening new accounts and securing both initial and
repeat orders for commercial implants of our r-SNM System in Europe and
Canada. The NICE briefing indicates key features and benefits of the
system and should further aid us in gaining traction in the U.K.
following our listing on the NHS online catalogue. Overall, we are
making excellent progress on our key operational and clinical
initiatives."
Third Quarter 2018 Financial Results
Net revenue was $0.2 million in the third quarter ended September
30, 2018, derived from the sale of the Company's r-SNM Systems to
customers in Europe and Canada as compared to net revenue of $0.1
million for the same period of last year.
Gross margin was 47.5% in the third quarter of 2018 compared to 7.9%
gross margin in the prior year period.
Operating expense was $7.6 million for the third quarter of 2018, as
compared to $4.6 million in the prior-year quarter. This increase was
primarily due to increases in legal, personnel, regulatory submissions
and clinical development costs.
Net loss for the period was $7.6 million as compared to $4.5 million in
the prior-year quarter. The net loss per share for the third quarter
of 2018 was $2.67 per share.
As of September 30, 2018, cash and cash equivalents and short-term
investments were $31.2 million.
Webcast and Conference Call
On Tuesday, December 11, 2018, at 4:30 p.m. Eastern Time, the Company
will host a conference call with the investment community to discuss the
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 5087907.
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, CA, is focused on development and
commercialization of novel implantable Sacral Neuromodulation devices
for patients with urinary and bowel dysfunction. Overactive bladder
affects an estimated 87 million adults in the U.S. and Europe. Another
approximately 40 million adults are reported to suffer from fecal
incontinence. SNM therapy is a well-established treatment that has been
widely used and reimbursed in Europe and the U.S. for the past two
decades. The Axonics r-SNM System is the first rechargeable Sacral
Neuromodulation system approved for sale in Europe, Canada and
Australia. For more information, visit the Company's website at www.axonicsmodulation.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.
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Axonics Modulation Technologies, Inc.Condensed
Consolidated Balance Sheets(in thousands, except
share and per share data)
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September 30,
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December 31,
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2018
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2017
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(unaudited)
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ASSETS
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Current assets
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Cash and cash equivalents
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$
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20,148
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$
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24,398
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Short-term investments
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11,069
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—
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Accounts receivable
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219
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—
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Inventory
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2,148
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1,541
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Prepaid expenses and other current assets
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1,751
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980
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Total current assets
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35,335
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26,919
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Property and equipment, net
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2,817
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1,530
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Intangible asset, net
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455
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541
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Other assets
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3,712
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422
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Total assets
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$
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42,319
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$
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29,412
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LIABILITIES, MEZZANINE EQUITY AND STOCKHOLDERS' DEFICIT
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Current liabilities
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Accounts payable
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$
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1,983
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$
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1,616
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Accrued liabilities
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2,713
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789
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Lease liability, current portion
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800
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—
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Total current liabilities
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5,496
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2,405
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Lease liability, net of current portion
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3,453
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135
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Debt, net of unamortized debt issuance costs
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9,056
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—
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Total liabilities
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18,005
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2,540
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Mezzanine Equity
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Convertible Preferred Stock
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Series A Convertible Preferred Stock, par value $0.0001, 1,030,000
shares authorized, 719,500 shares issued and outstanding at
September 30, 2018 and December 31, 2017; aggregate liquidation
preference of $15,829 at September 30, 2018 and December 31, 2017
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14,021
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14,021
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Series B-1 Convertible Preferred Stock, par value $0.0001, 2,529,862
shares authorized, 1,925,302 shares issued and outstanding at
September 30, 2018 and December 31, 2017; aggregate liquidation
preference of $15,248 at September 30, 2018 and December 31, 2017
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13,757
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13,757
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Series B-2 Convertible Preferred Stock, par value $0.0001, 2,537,231
shares authorized, 2,213,794 shares issued and outstanding at
September 30, 2018 and December 31, 2017; aggregate liquidation
preference of $19,481 at September 30, 2018 and December 31, 2017
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17,572
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17,572
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Series C Convertible Preferred Stock, par value $0.0001, 6,188,888
and 3,888,889 shares authorized at September 30, 2018 and December
31, 2017, respectively; 4,131,546 and 1,898,213 shares issued and
outstanding at September 30, 2018 and December 31, 2017,
respectively; aggregate liquidation preference of $37,184 and
$17,084 at September 30, 2018 and December 31, 2017, respectively
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36,776
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16,877
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Noncontrolling interest in Axonics Europe, S.A.S.
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31,066
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31,066
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Stockholders' Deficit
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Common Stock, par value $0.0001, 17,500,000 and 15,000,000 shares
authorized at September 30, 2018 and December 31, 2017,
respectively; 2,830,591 and 2,776,583 shares issued and outstanding
at September 30, 2018 and December 31, 2017, respectively
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—
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—
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Additional paid-in capital
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3,336
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2,900
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Stock subscriptions receivable
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(1,824
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)
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(1,753
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)
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Accumulated deficit
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(89,984
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)
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(67,166
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)
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Accumulated other comprehensive loss
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(406
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)
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(402
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)
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Total stockholders' deficit
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(88,878
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(66,421
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)
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Total liabilities, mezzanine equity and stockholders' deficit
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$
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42,319
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$
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29,412
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Axonics Modulation Technologies, Inc.Condensed
Consolidated Statements of Comprehensive Loss(in
thousands, except share and per share data)(unaudited)
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Three Months Ended
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Nine Months Ended
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September 30,
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September 30,
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2018
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2017
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2018
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2017
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Net revenue
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$
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201
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$
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128
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$
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213
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$
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128
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Cost of goods sold
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106
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118
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111
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118
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Gross profit
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95
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10
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102
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10
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Operating Expenses
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Research and development
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3,898
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3,132
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14,619
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8,959
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General and administrative
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2,790
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1,103
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5,861
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3,520
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Sales and marketing
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949
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368
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2,308
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767
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Total operating expenses
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7,637
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4,603
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22,788
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13,246
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Loss from operations
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(7,542
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)
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(4,593
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)
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(22,686
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)
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(13,236
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)
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Other Income (Expense)
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Interest income
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172
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|
79
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448
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|
|
121
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Other expense
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(196
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)
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(8
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(579
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)
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(13
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Other income (expense), net
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(24
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71
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(131
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)
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108
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Loss before income tax expense
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(7,566
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)
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(4,522
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)
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(22,817
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)
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(13,128
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)
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Income tax expense
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—
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—
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1
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|
|
1
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Net loss
|
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(7,566
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)
|
|
(4,522
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)
|
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(22,818
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)
|
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(13,129
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)
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Foreign currency translation adjustment
|
|
(1
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)
|
|
519
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|
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(4
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)
|
|
588
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Comprehensive loss
|
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$
|
(7,567
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)
|
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$
|
(4,003
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)
|
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$
|
(22,822
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)
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$
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(12,541
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)
|
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Net loss per share, basic and diluted
|
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$
|
(2.67
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)
|
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$
|
(1.67
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)
|
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$
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(8.10
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)
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$
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(5.26
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)
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Weighted-average shares used to compute basic and diluted net loss
per share
|
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2,830,591
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|
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2,705,138
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|
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2,817,652
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|
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2,494,424
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