Full Press Release Details
Axonics Reports First Quarter 2020 Results
IRVINE, CA - May 5, 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, today reported financial results for the first quarter 2020 and provided an update on operational initiatives.
Recent Business & Financial Highlights
Raymond W. Cohen, CEO of Axonics, commented, "We are quite proud of this quarter's exceptional revenue result considering we had only been in the market for two months prior to the start of 2020. Moreover, we believe that this result ranks among the highest revenue total generated in the history of the medical device industry for a company's first full quarter of sales in the U.S. following FDA approval. The results are a testament to the quality of our 170 person U.S. commercial team and were driven by the overwhelmingly positive response from the SNM implanting community and their patients to the introduction of a bespoke SNM device that is intuitive, fuss-free, long-lived, MRI compatible, safe and clinically effective. This quarter's results reinforce our confidence that the SNM market is poised for meaningful expansion in the years ahead, driven to a large extent by Axonics' continuous innovation and commitment to increasing patient awareness. As elective procedures are rescheduled, we expect to be very active in the months ahead as more patients say yes' to Axonics and SNM therapy. Despite the setback from COVID-19, we remain bullish about our prospects for continued growth in 2020 and beyond."
Mr. Cohen continued, "The Axonics team would like to express its gratitude to the courageous and selfless healthcare workers providing care for those impacted by COVID-19. At Axonics, we remain focused on supporting our customers and their patients as well as protecting the health of our employees and their families."
First Quarter 2020 Financial Results
Webcast and Conference Call
Axonics will host a conference call with the investment community today, May 5, 2020, at 4:30 p.m. Eastern Time, to discuss financial results and recent business developments.
Interested parties may access the live teleconference by dialing 866-687-5771 (U.S.) or 409-217-8725 (International) and using conference ID 6654699.
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.axonics.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.
Axonics Modulation Technologies, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
| March 31, | December 31, | ||||||
| 2020 | 2019 | ||||||
| (unaudited) | |||||||
| ASSETS | |||||||
| Current assets | |||||||
| Cash and cash equivalents | $ | 159,820 | $ | 171,082 | |||
| Short-term investments | - | 12,592 | |||||
| Accounts receivable, net of allowance for doubtful accounts of $589 and $75 at March 31, 2020 and December 31, 2019, respectively | 20,770 | 7,879 | |||||
| Inventory, net | 19,230 | 15,659 | |||||
| Prepaid expenses and other current assets | 4,245 | 4,468 | |||||
| Total current assets | 204,065 | 211,680 | |||||
| Property and equipment, net | 5,406 | 3,047 | |||||
| Intangible asset, net | 282 | 311 | |||||
| Other assets | 7,626 | 4,784 | |||||
| Total assets | $ | 217,379 | $ | 219,822 | |||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
| Current liabilities | |||||||
| Accounts payable | $ | 7,440 | $ | 5,882 | |||
| Accrued liabilities | 3,110 | 2,174 | |||||
| Accrued compensation and benefits | 3,503 | 3,375 | |||||
| Operating lease liability, current portion | 794 | 602 | |||||
| Debt, current portion | 5,000 | - | |||||
| Total current liabilities | 19,847 | 12,033 | |||||
| Operating lease liability, net of current portion | 9,485 | 4,450 | |||||
| Debt, net of unamortized debt issuance costs, net of current portion | 15,571 | 20,336 | |||||
| Total liabilities | 44,903 | 36,819 | |||||
| Stockholders' equity | |||||||
| Preferred stock, par value $0.0001 per share; 10,000,000 shares authorized, no shares issued and outstanding at March 31, 2020 and December 31, 2019 | - | - | |||||
| Common stock, par value $0.0001, 50,000,000 shares authorized at March 31, 2020 and December 31, 2019; 34,510,662 and 34,110,995 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively | 3 | 3 | |||||
| Additional paid-in capital | 367,278 | 363,012 | |||||
| Accumulated deficit | (194,200 | ) | (179,584 | ) | |||
| Accumulated other comprehensive loss | (605 | ) | (428 | ) | |||
| Total stockholders' equity | 172,476 | 183,003 | |||||
| Total liabilities and stockholders' equity | $ | 217,379 | $ | 219,822 |
Axonics Modulation Technologies, Inc.
Condensed Consolidated Statements of Comprehensive Loss
(in thousands, except share and per share data)
| Three Months Ended March 31, | |||||||
| 2020 | 2019 | ||||||
| Net revenue | $ | 26,296 | $ | 1,077 | |||
| Cost of goods sold | 9,895 | 548 | |||||
| Gross profit | 16,401 | 529 | |||||
| Operating Expenses | |||||||
| Research and development | 6,884 | 4,219 | |||||
| General and administrative | 7,653 | 4,015 | |||||
| Sales and marketing | 16,569 | 5,914 | |||||
| Total operating expenses | 31,106 | 14,148 | |||||
| Loss from operations | (14,705 | ) | (13,619 | ) | |||
| Other Income (Expense) | |||||||
| Interest income | 642 | 1,034 | |||||
| Interest and other expense | (552 | ) | (532 | ) | |||
| Other income, net | 90 | 502 | |||||
| Loss before income tax expense | (14,615 | ) | (13,117 | ) | |||
| Income tax expense | 1 | - | |||||
| Net loss | (14,616 | ) | (13,117 | ) | |||
| Foreign currency translation adjustment | (177 | ) | (10 | ) | |||
| Comprehensive loss | $ | (14,793 | ) | $ | (13,127 | ) | |
| Net loss per share, basic and diluted | $ | (0.43 | ) | $ | (0.47 | ) | |
| Weighted-average shares used to compute basic and diluted net loss per share | 33,637,646 | 27,828,201 |