Axonics® Reports Second Quarter 2020 Results
Financial Highlights
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Net revenue was
$15.2 million in the second quarter endedJune 30, 2020 as compared to net revenue of$1.5 million for the same period of the prior year. Net revenue for the first half of 2020 was$41.5 million as compared to$2.6 million for the first half of 2019.- As previously disclosed, new order flow was de minimis in April due to COVID-19 related restrictions on elective procedures and began a gradual recovery in early May as restrictions were lifted in certain states. New orders in June continued to improve. Average weekly new order flow in June was approximately 70% of the weekly average achieved in the first quarter of 2020 prior to the COVID-19 related postponement of elective procedures in mid-March.
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Axonics raised
$140 million of net proceeds in a public equity offering inMay 2020 . As ofJune 30, 2020 , cash and cash equivalents were$288 million .
Business and Clinical Highlights
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Through the end of
July 2020 , over 540 unique accounts (hospitals and ambulatory surgery centers) in theU.S. have implanted the Axonics r-SNM System® in patients on an outpatient basis since the product launched inNovember 2019 . -
Since the
U.S. launch, over 135 corporate agreements have been signed with national and regional integrated delivery networks (IDN) as well as large urology groups and ambulatory surgery centers. Included in this group are agreements with 12 of the largest 17 national IDNs in theU.S. - Axonics recently reported 2-year topline clinical results from its ARTISAN-SNM pivotal study. At 2-years post-implant, 88% of all patients were therapy responders, consistent with the 89% therapy responder rate reported at 1-year. The 2-year results demonstrate that patients continue to experience clinically meaningful and statistically significant improvements in urinary urgency incontinence symptoms and quality of life. Eighty percent of patients achieved >75% reduction in symptoms, with 37% being completely dry. There were no serious or unanticipated device related events.
Regulatory Approvals
-
In
April 2020 , theU.S. Food & Drug Administration (FDA) approved a next generation rechargeable implantable neurostimulator (INS) for the Axonics r-SNM System under a premarket approval (PMA) supplement. The new INS extends the recharge interval for patients to only once a month for about one hour and for some patients, only once every two months. The next generation Axonics INS is shipping toU.S. customers this week. -
In
June 2020 , the FDA approved a new wireless patient remote control with SmartMRI™ technology for the Axonics r-SNM System under a PMA supplement. The new remote control simplifies the process by which patients can receive a full-body MRI. An MRI technician can perform a simple check using a patient’s remote control immediately prior to an MRI, avoiding the need for the patient to visit their implanting physician’s office or involving personnel from Axonics. -
In
July 2020 , the FDA approved 3T full-body MRI conditional labeling for the Axonics r-SNM System under a PMA supplement. With this incremental approval, the Axonics device is MRI compatible for both 1.5T and 3T full-body scans.
Second Quarter 2020 Financial Results
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Net revenue was
$15.2 million in the second quarter 2020, as compared to net revenue of$1.5 million for the same period of the prior year. Net revenue from theU.S. accounted for$14.6 million , with select European markets andCanada accounting for the balance of second quarter 2020 revenue. - Gross margin was 44.4% in the second quarter 2020, as compared to 48.1% for the same period of the prior year. The decrease in gross margin was primarily due to lower overhead absorption related to the COVID-19 pandemic in second quarter 2020. Management anticipates gross margin will return to the low to mid sixty percent range in the second half of 2020 and anticipates the low to mid seventy percent range over the longer-term.
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Operating expenses were
$26.2 million in the second quarter 2020, as compared to$20.0 million for the same period of the prior year. This increase was primarily due to higher personnel costs for theU.S. commercial team and in other parts of the organization. -
Net loss was
$19.8 million in the second quarter 2020, as compared to a net loss of$19.1 million for the same period of the prior year. Cash used in operating activities in the second quarter 2020 was$13.0 million . -
As of
June 30, 2020 , cash and cash equivalents were$288 million .
Webcast and Conference Call
Axonics will host a conference call today,
Interested parties may access the live teleconference by dialing 866-687-5771 (
A live webcast of the conference call may be accessed by visiting the Events & Presentations section of the Axonics investor relations website at ir.axonics.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the Axonics website for 90 days.
About
Axonics, based in
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
Condensed Consolidated Balance Sheets (in thousands, except share and per share data) |
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2020 |
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2019 |
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(unaudited) |
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ASSETS |
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|
|
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Current assets |
|
|
|
|||||
Cash and cash equivalents |
$ |
287,679 |
|
|
$ |
171,082 |
|
|
Short-term investments |
|
— |
|
|
|
12,592 |
|
|
Accounts receivable, net of allowance for doubtful accounts of |
|
14,115 |
|
|
|
7,879 |
|
|
Inventory, net |
|
30,138 |
|
|
|
15,659 |
|
|
Prepaid expenses and other current assets |
|
3,573 |
|
|
|
4,468 |
|
|
Total current assets |
|
335,505 |
|
|
|
211,680 |
|
|
Property and equipment, net |
|
5,562 |
|
|
|
3,047 |
|
|
Intangible asset, net |
|
254 |
|
|
|
311 |
|
|
Other assets |
|
7,415 |
|
|
|
4,784 |
|
|
Total assets |
$ |
348,736 |
|
|
$ |
219,822 |
|
|
|
|
|
|
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities |
|
|
|
|||||
Accounts payable |
$ |
10,728 |
|
|
$ |
5,882 |
|
|
Accrued liabilities |
|
3,961 |
|
|
|
2,174 |
|
|
Accrued compensation and benefits |
|
5,289 |
|
|
|
3,375 |
|
|
Operating lease liability, current portion |
|
851 |
|
|
|
602 |
|
|
Debt, current portion |
|
10,000 |
|
|
|
— |
|
|
Total current liabilities |
|
30,829 |
|
|
|
12,033 |
|
|
Operating lease liability, net of current portion |
|
9,261 |
|
|
|
4,450 |
|
|
Debt, net of unamortized debt issuance costs, net of current portion |
|
10,750 |
|
|
|
20,336 |
|
|
Total liabilities |
|
50,840 |
|
|
|
36,819 |
|
|
Stockholders’ equity |
|
|
|
|||||
Preferred stock, par value |
|
— |
|
|
|
— |
|
|
Common stock, par value |
|
4 |
|
|
|
3 |
|
|
Additional paid-in capital |
|
512,588 |
|
|
|
363,012 |
|
|
Accumulated deficit |
|
(213,983 |
) |
|
|
(179,584 |
) |
|
Accumulated other comprehensive loss |
|
(713 |
) |
|
|
(428 |
) |
|
Total stockholders’ equity |
|
297,896 |
|
|
|
183,003 |
|
|
Total liabilities and stockholders’ equity |
$ |
348,736 |
|
|
$ |
219,822 |
|
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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Six Months Ended
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2020 |
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2019 |
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2020 |
|
2019 |
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Net revenue |
$ |
15,213 |
|
|
$ |
1,488 |
|
|
$ |
41,509 |
|
|
$ |
2,565 |
|
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Cost of goods sold |
|
8,463 |
|
|
|
772 |
|
|
|
18,358 |
|
|
|
1,320 |
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Gross profit |
|
6,750 |
|
|
|
716 |
|
|
|
23,151 |
|
|
|
1,245 |
|
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Operating Expenses |
|
|
|
|
|
|
|
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Research and development |
|
6,398 |
|
|
|
4,874 |
|
|
|
13,282 |
|
|
|
9,093 |
|
|
General and administrative |
|
5,537 |
|
|
|
4,362 |
|
|
|
13,190 |
|
|
|
8,377 |
|
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Sales and marketing |
|
14,220 |
|
|
|
10,750 |
|
|
|
30,789 |
|
|
|
16,664 |
|
|
Total operating expenses |
|
26,155 |
|
|
|
19,986 |
|
|
|
57,261 |
|
|
|
34,134 |
|
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Loss from operations |
|
(19,405 |
) |
|
|
(19,270 |
) |
|
|
(34,110 |
) |
|
|
(32,889 |
) |
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Other Income (Expense) |
|
|
|
|
|
|
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Interest income |
|
65 |
|
|
|
839 |
|
|
|
707 |
|
|
|
1,873 |
|
|
Interest and other expense |
|
(443 |
) |
|
|
(629 |
) |
|
|
(995 |
) |
|
|
(1,161 |
) |
|
Other income (expense), net |
|
(378 |
) |
|
|
210 |
|
|
|
(288 |
) |
|
|
712 |
|
|
Loss before income tax expense |
|
(19,783 |
) |
|
|
(19,060 |
) |
|
|
(34,398 |
) |
|
|
(32,177 |
) |
|
Income tax expense |
|
— |
|
|
|
1 |
|
|
|
1 |
|
|
|
1 |
|
|
Net loss |
|
(19,783 |
) |
|
|
(19,061 |
) |
|
|
(34,399 |
) |
|
|
(32,178 |
) |
|
Foreign currency translation adjustment |
|
(108 |
) |
|
|
(43 |
) |
|
|
(285 |
) |
|
|
(53 |
) |
|
Comprehensive loss |
$ |
(19,891 |
) |
|
$ |
(19,104 |
) |
|
$ |
(34,684 |
) |
|
$ |
(32,231 |
) |
|
|
|
|
|
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Net loss per share, basic and diluted |
$ |
(0.54 |
) |
|
$ |
(0.68 |
) |
|
$ |
(0.98 |
) |
|
$ |
(1.15 |
) |
|
Weighted-average shares used to compute basic and diluted net loss per share |
|
36,440,846 |
|
|
|
27,945,393 |
|
|
|
35,040,180 |
|
|
|
27,887,121 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20200806005835/en/
Investor Relations
949-336-5293
IR@axonics.com
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