Delaware | 001-38721 | 45-4744083 | ||
(State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |
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)) |
Emerging growth company | ý |
Title of class | Trading symbol | Name of exchange on which registered |
Common stock, par value $0.0001 per share | AXNX | Nasdaq Global Select Market |
Exhibit No. | Description | |
99.1 |
AXONICS MODULATION TECHNOLOGIES, INC. | ||||
Date: November 14, 2019 | By: | /s/ Raymond W. Cohen | ||
Raymond W. Cohen | ||||
Chief Executive Officer |
• | 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. |
• | 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. |
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 |
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 |