Full Press Release Details
Axonics Announces Fourth Quarter and
Fiscal 2019 Financial Results
IRVINE, CA - March 4, 2020 - 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 fourth quarter and year ended December 31, 2019 and provided an update on operational initiatives.
Recent Business & Financial Highlights
Raymond W. Cohen, CEO of Axonics commented, "The initial results of our U.S. launch clearly exceeded our expectations. These results were achieved based not only on the quality of our product and the demand from SNM implanters for a long-lived innovative product, but also can be attributed to the investment of time and capital we made to recruit, hire and train over 145 U.S. sales and clinical specialists during 2019 in advance of FDA approval."
Cohen continued, "The velocity of sales in the U.S. has continued in Q1 of 2020 with over 300 U.S. institutions now implanting our r-SNM System nationwide in the first quarter. Physician feedback has been very positive regarding patient outcomes and the support they are receiving from the Axonics team. We expect our momentum to continue throughout 2020 as more institutions begin implanting our device. We fully expect the U.S. market for SNM to increase based on the notion that more patients are choosing SNM given the
attractive proposition of a 15+ year implant that does not require explant in the event that an MRI scan is needed."
Fourth Quarter 2019 Financial Results
2019 Fiscal Year Financial Results
Webcast and Conference Call
Today, on Wednesday March 4, 2020, 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 8582626.
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 impact 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.
Vice President, Investor Relations
Axonics Modulation Technologies, Inc.
Consolidated Balance Sheets
(in thousands, except share and per share data)
| December 31, | |||||||
| 2019 | 2018 | ||||||
| ASSETS | |||||||
| Current assets | |||||||
| Cash and cash equivalents | $ | 171,082 | $ | 98,306 | |||
| Short-term investments | 12,592 | 59,218 | |||||
| Accounts receivable, net of allowance for doubtful accounts of $75 and $0 at December 31, 2019 and 2018, respectively | 7,879 | 427 | |||||
| Inventory, net | 15,659 | 3,673 | |||||
| Prepaid expenses and other current assets | 4,468 | 3,716 | |||||
| Total current assets | 211,680 | 165,340 | |||||
| Property and equipment, net | 3,047 | 2,784 | |||||
| Intangible asset, net | 311 | 426 | |||||
| Other assets | 4,784 | 3,356 | |||||
| Total assets | $ | 219,822 | $ | 171,906 | |||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
| Current liabilities | |||||||
| Accounts payable | $ | 5,882 | $ | 3,436 | |||
| Accrued liabilities | 2,174 | 1,019 | |||||
| Accrued compensation and benefits | 3,375 | 664 | |||||
| Operating lease liability, current portion | 602 | 768 | |||||
| Total current liabilities | 12,033 | 5,887 | |||||
| Operating lease liability, net of current portion | 4,450 | 3,281 | |||||
| Debt, net of unamortized debt issuance costs | 20,336 | 19,463 | |||||
| Total liabilities | 36,819 | 28,631 | |||||
| Stockholders' Equity | |||||||
| Preferred stock, par value $0.0001 per share; 10,000,000 shares authorized, no shares issued and outstanding at December 31, 2019 and 2018 | - | - | |||||
| Common stock, par value $0.0001, 50,000,000 shares authorized at December 31, 2019 and 2018; 34,110,995 and 27,806,934 shares issued and outstanding at December 31, 2019 and 2018, respectively | 3 | 3 | |||||
| Additional paid-in capital | 363,012 | 243,337 | |||||
| Accumulated deficit | (179,584 | ) | (99,649 | ) | |||
| Accumulated other comprehensive loss | (428 | ) | (416 | ) | |||
| Total stockholders' equity | 183,003 | 143,275 | |||||
| Total liabilities and stockholders' equity | $ | 219,822 | $ | 171,906 |
Axonics Modulation Technologies, Inc.
Consolidated Statements of Comprehensive Loss
(in thousands, except share and per share data)
| Three Months Ended December 31, | Years Ended December 31, | ||||||||||||||
| 2019 | 2018 | 2019 | 2018 | ||||||||||||
| (unaudited) | (unaudited) | ||||||||||||||
| Net revenue | $ | 9,946 | $ | 494 | $ | 13,820 | $ | 707 | |||||||
| Cost of goods sold | 4,538 | 245 | 6,490 | 356 | |||||||||||
| Gross profit | 5,408 | 249 | 7,330 | 351 | |||||||||||
| Operating Expenses | |||||||||||||||
| Research and development | 6,233 | 4,783 | 20,181 | 19,402 | |||||||||||
| General and administrative | 5,537 | 3,501 | 19,076 | 9,362 | |||||||||||
| Sales and marketing | 16,301 | 1,416 | 48,672 | 3,724 | |||||||||||
| Total operating expenses | 28,071 | 9,700 | 87,929 | 32,488 | |||||||||||
| Loss from operations | (22,663 | ) | (9,451 | ) | (80,599 | ) | (32,137 | ) | |||||||
| Other Income (Expense) | |||||||||||||||
| Interest income | 474 | 550 | 2,974 | 998 | |||||||||||
| Interest and other expense | (562 | ) | (764 | ) | (2,309 | ) | (1,343 | ) | |||||||
| Other income (expense), net | (88 | ) | (214 | ) | 665 | (345 | ) | ||||||||
| Loss before income tax expense | (22,751 | ) | (9,665 | ) | (79,934 | ) | (32,482 | ) | |||||||
| Income tax expense | - | - | 1 | 1 | |||||||||||
| Net loss | (22,751 | ) | (9,665 | ) | (79,935 | ) | (32,483 | ) | |||||||
| Foreign currency translation adjustment | 153 | (10 | ) | (12 | ) | (14 | ) | ||||||||
| Comprehensive loss | $ | (22,598 | ) | $ | (9,675 | ) | $ | (79,947 | ) | $ | (32,497 | ) | |||
| Net loss per share, basic and diluted | $ | (0.75 | ) | $ | (0.50 | ) | $ | (2.80 | ) | $ | (4.64 | ) | |||
| Weighted-average shares used to compute basic and diluted net loss per share | 30,374,223 | 19,402,008 | 28,567,302 | 6,997,777 |