Full Press Release Details
Axonics Reports Second Quarter 2020 Results
IRVINE, CA - August 6, 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 second quarter 2020 and provided an update on operational initiatives.
Financial Highlights
Business and Clinical Highlights
Regulatory Approvals
Raymond W. Cohen, Axonics CEO, commented, "Axonics was exceptionally productive in the second quarter, having built a significant quantity of finished goods inventory, signed numerous IDN agreements, added over 110 new accounts, and gained several FDA approvals. Despite COVID-19 flare-ups in certain geographies, based on the number of accounts that have switched to Axonics and the trajectory of new order flow in July, we are confident that Axonics is well positioned for continued strong growth in the second half of 2020."
Mr. Cohen continued, "The responder rate from the ARTISAN-SNM pivotal study is the highest success rate ever reported in SNM clinical literature and will soon appear in print in a peer-reviewed journal. More importantly, these results are being replicated by hundreds of physicians in commercial cases all over the U.S. These clinical results, when combined with other key features of our SNM System such as a 15+ year life, recharging only once per month for an hour, full-body MRI compatibility, and ease of use create significant and distinct advantages over the competitive offering. The overwhelmingly positive feedback from physicians, their staff and patients on their experience with Axonics supports our conviction that SNM is poised for significant market expansion in the years ahead."
Second Quarter 2020 Financial Results
Webcast and Conference Call
Axonics will host a conference call today, August 6, 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 2397731.
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 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 impacts 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. Axonics SNM therapy, which has been clinically proven to reduce symptoms and restore pelvic floor function, is now being offered at hundreds of medical centers across the U.S. and in dozens of select hospitals in Western Europe. Reimbursement coverage is well established in the U.S. and is a covered service in most European countries. The Axonics System is the first long-lived rechargeable SNM system approved for sale in the world, and the first to gain full-body MRI conditional labeling. For more information, visit 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)
| June 30, | December 31, | ||||||
| 2020 | 2019 | ||||||
| (unaudited) | |||||||
| ASSETS | |||||||
| Current assets | |||||||
| Cash and cash equivalents | $ | 287,679 | $ | 171,082 | |||
| Short-term investments | - | 12,592 | |||||
| Accounts receivable, net of allowance for doubtful accounts of $589 and $75 at June 30, 2020 and December 31, 2019, respectively | 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 | |||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
| 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 $0.0001 per share; 10,000,000 shares authorized, no shares issued and outstanding at June 30, 2020 and December 31, 2019 | - | - | |||||
| Common stock, par value $0.0001, 50,000,000 shares authorized at June 30, 2020 and December 31, 2019; 39,462,405 and 34,110,995 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively | 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 |
Axonics Modulation Technologies, Inc.
Condensed Consolidated Statements of Comprehensive Loss
(in thousands, except share and per share data)
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| 2020 | 2019 | 2020 | 2019 | ||||||||||||
| Net revenue | $ | 15,213 | $ | 1,488 | $ | 41,509 | $ | 2,565 | |||||||
| Cost of goods sold | 8,463 | 772 | 18,358 | 1,320 | |||||||||||
| Gross profit | 6,750 | 716 | 23,151 | 1,245 | |||||||||||
| Operating Expenses | |||||||||||||||
| Research and development | 6,398 | 4,874 | 13,282 | 9,093 | |||||||||||
| General and administrative | 5,537 | 4,362 | 13,190 | 8,377 | |||||||||||
| Sales and marketing | 14,220 | 10,750 | 30,789 | 16,664 | |||||||||||
| Total operating expenses | 26,155 | 19,986 | 57,261 | 34,134 | |||||||||||
| Loss from operations | (19,405 | ) | (19,270 | ) | (34,110 | ) | (32,889 | ) | |||||||
| Other Income (Expense) | |||||||||||||||
| 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 | ) | |||
| 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 |