Recent Highlights
- Revenue of
$16.2 million for the third quarter 2019, representing a 21% increase over third quarter 2018 - U.S. revenue of
$14.9 million for the third quarter 2019, representing a 22% increase over third quarter 2018 - Published five-year prospective study results on 103 patients treated with iFuse Implant System, showing continued durability of clinical response and positive radiographic outcomes
- Obtained positive coverage from
Wellmark Blue Cross Blue Shield for 1.5 million members inSouth Dakota andIowa and transitioned Health New England to exclusive iFuse coverage for minimally invasive SI joint fusion - Announced the
Medicare physician payment increase of 27% for minimally invasive SI joint fusion
“We continue to focus on accelerating our growth by hiring sales people, training surgeons, and launching new products like Bedrock,” said Jeffrey Dunn, President, Chief Executive Officer, and Chairman. “In addition, we are working to influence positive reimbursement coverage by the remaining large payors in the U.S. with the publication of our five-year prospective clinical data. We are also pleased with the decision by
Third Quarter 2019 Financial Results
Revenue was
Gross margin was 90% for the third quarter 2019, as compared to 91% in the corresponding prior year period. The change in gross margin was due to an increase in personnel in operations to support the growth of the business.
Operating expenses were
Operating loss was
Net loss was
Cash and marketable securities were
2019 Financial Guidance
Webcast and Conference Call Information
About
The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. The iFuse Implant System is also intended for sacroiliac fusion to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. Rx Only. For indications, risks, and safety information visit: www.si-bone.com/risks.
Forward Looking Statements
The statements in this press release regarding SI-BONE’s continued growth and financial outlook are “forward-looking” statements. These forward-looking statements are based on SI-BONE’s current expectations and inherently involve significant risks and uncertainties. These statements and risks include SI-BONE’s ability to expand its sales and marketing capabilities and increase surgeon demand for iFuse, increase revenue through new products, obtain favorable coverage and reimbursement determinations from third-party payors, and fulfill its projections about 2019 full year revenue. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of the risks and uncertainties, which are described in SI-BONE’s filings on Form 10-K and Form 10-Q and SI-BONE’s other filings with the
Investor Contact:
investors@SI-BONE.com
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share amounts)
(unaudited)
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
Revenue | $ | 16,182 | $ | 13,381 | $ | 47,490 | $ | 39,756 | ||||||||
Cost of goods sold | 1,630 | 1,221 | 4,744 | 3,451 | ||||||||||||
Gross profit | 14,552 | 12,160 | 42,746 | 36,305 | ||||||||||||
Gross margin | 90 | % | 91 | % | 90 | % | 91 | % | ||||||||
Operating expenses: | ||||||||||||||||
Sales and marketing | 16,443 | 10,605 | 48,985 | 31,890 | ||||||||||||
Research and development | 1,874 | 1,373 | 5,503 | 3,875 | ||||||||||||
General and administrative | 6,816 | 3,226 | 15,776 | 8,198 | ||||||||||||
Total operating expenses | 25,133 | 15,204 | 70,264 | 43,963 | ||||||||||||
Loss from operations | (10,581 | ) | (3,044 | ) | (27,518 | ) | (7,658 | ) | ||||||||
Interest and other income (expense), net: | ||||||||||||||||
Interest income | 612 | 69 | 2,051 | 199 | ||||||||||||
Interest expense | (1,243 | ) | (1,282 | ) | (3,706 | ) | (3,826 | ) | ||||||||
Other expense, net | (94 | ) | (535 | ) | (132 | ) | (855 | ) | ||||||||
Net loss | $ | (11,306 | ) | $ | (4,792 | ) | $ | (29,305 | ) | $ | (12,140 | ) | ||||
Net loss per share, basic and diluted | $ | (0.46 | ) | $ | (1.29 | ) | $ | (1.19 | ) | $ | (3.34 | ) | ||||
Weighted-average number of common shares used to compute basic and diluted net loss per share | 24,803,452 | 3,712,876 | 24,596,788 | 3,638,905 |
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
September 30, | December 31, | |||||||
2019 | 2018 | |||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 12,614 | $ | 25,120 | ||||
Short-term investments | 83,609 | 97,103 | ||||||
Accounts receivable, net | 9,918 | 8,486 | ||||||
Inventory | 4,953 | 3,343 | ||||||
Prepaid expenses and other current assets | 1,619 | 1,990 | ||||||
Total current assets | 112,713 | 136,042 | ||||||
Long-term investments | 5,273 | — | ||||||
Property and equipment, net | 3,025 | 2,154 | ||||||
Other non-current assets | 305 | 325 | ||||||
TOTAL ASSETS | $ | 121,316 | $ | 138,521 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 2,623 | $ | 2,146 | ||||
Accrued liabilities and other | 10,211 | 6,860 | ||||||
Total current liabilities | 12,834 | 9,006 | ||||||
Long-term borrowings | 39,158 | 38,963 | ||||||
Other long-term liabilities | 363 | 360 | ||||||
TOTAL LIABILITIES | 52,355 | 48,329 | ||||||
Stockholders' Equity: | ||||||||
Common stock and additional paid-in capital | 254,968 | 246,930 | ||||||
Accumulated other comprehensive income | 475 | 439 | ||||||
Accumulated deficit | (186,482 | ) | (157,177 | ) | ||||
TOTAL STOCKHOLDERS' EQUITY | 68,961 | 90,192 | ||||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 121,316 | $ | 138,521 |
Source: SI-BONE, Inc.