Recent Highlights
- Revenues of
$15.0 million for the first quarter of 2019, representing an 18% increase over first quarter 2018 - Received
FDA 510(k) clearance for a broader indication, encompassing fusion to augment stabilization of the sacroiliac joint in long-construct procedures using the iFuse Bedrock technology - Launched a suite of single-use decorticator products in the U.S.
- Received positive reimbursement coverage from
BlueCross BlueShield of Alabama and convertedBlueCross BlueShield of Vermont and Highmark BlueCross BlueShield to exclusive reimbursement coverage - Appointed
Bruce Prothro as Vice President, Regulatory Affairs
“We are pleased to report first quarter results where we began to capitalize on recent, exclusive U.S. reimbursement coverage decisions with execution on sales force expansion and surgeon education,” said Jeffrey Dunn, President, Chief Executive Officer, and Chairman. “I am encouraged by the momentum we are building and remain confident that we are executing toward our goals and that our business outlook remains strong. Our team is clear on what we need to accomplish to unleash the market opportunity in the sacropelvic space.”
First Quarter 2019 Financial Results
Revenue was
Gross margin was 90% for the first quarter of 2019, as compared to 92% 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, cash equivalents and short-term investments were
2019 Financial Guidance
Webcast and Conference Call Information
About
SI‐BONE is a medical device company that pioneered the iFuse Implant System, a minimally invasive surgical system for fusion of the sacroiliac joint to treat sacroiliac joint dysfunction. The SI joint is the last major joint with a clinically proven surgical treatment. The iFuse Implant, commercially available since 2009, is the only SI joint fusion device supported by multiple prospective clinical studies showing improved pain, patient function and quality of life resulting from treatment. There are over 65 peer‐reviewed publications supporting the safety, durable effectiveness, and biomechanical and economic benefits unique to the iFuse Implant (www.si-bone.com/results). This body of evidence has enabled multiple government and private insurance payors to establish coverage of the SI joint fusion procedure exclusively when performed with the iFuse Implant System.
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.
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 our 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 the company’s filings on Form 10-K and Form 10-Q and the company’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 March 31, | ||||||||
| 2019 | 2018 | |||||||
| Revenue | $ | 14,991 | $ | 12,712 | ||||
| Cost of goods sold | 1,526 | 1,048 | ||||||
| Gross profit | 13,465 | 11,664 | ||||||
| Operating expenses: | ||||||||
| Sales and marketing | 15,815 | 10,967 | ||||||
| Research and development | 1,683 | 1,206 | ||||||
| General and administrative | 4,766 | 2,408 | ||||||
| Total operating expenses | 22,264 | 14,581 | ||||||
| Loss from operations | (8,799 | ) | (2,917 | ) | ||||
| Interest and other income (expense), net: | ||||||||
| Interest income | 744 | 62 | ||||||
| Interest expense | (1,230 | ) | (1,275 | ) | ||||
| Other expense, net | (60 | ) | (71 | ) | ||||
| Net loss | $ | (9,345 | ) | $ | (4,201 | ) | ||
| Net loss per share, basic and diluted | $ | (0.38 | ) | $ | (1.17 | ) | ||
| Weighted-average number of common shares used to compute basic and diluted net loss per share |
24,390,648 | 3,593,658 | ||||||
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
| March 31, | December 31, | |||||||
| 2019 | 2018 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 12,561 | $ | 25,120 | ||||
| Short-term investments | 102,748 | 97,103 | ||||||
| Accounts receivable, net | 8,411 | 8,486 | ||||||
| Inventory | 3,516 | 3,343 | ||||||
| Prepaid expenses and other current assets | 2,161 | 1,990 | ||||||
| Total current assets | 129,397 | 136,042 | ||||||
| Property and equipment, net | 2,336 | 2,154 | ||||||
| Other non-current assets | 321 | 325 | ||||||
| TOTAL ASSETS | $ | 132,054 | $ | 138,521 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,811 | $ | 2,146 | ||||
| Accrued liabilities and other | 7,097 | 6,860 | ||||||
| Total current liabilities | 9,908 | 9,006 | ||||||
| Long-term borrowings | 39,028 | 38,963 | ||||||
| Other long-term borrowings | 363 | 360 | ||||||
| TOTAL LIABILITIES | 49,299 | 48,329 | ||||||
| Stockholders' Equity: | ||||||||
| Common stock and additional paid-in capital | 248,832 | 246,930 | ||||||
| Accumulated other comprehensive income | 445 | 439 | ||||||
| Accumulated deficit | (166,522 | ) | (157,177 | ) | ||||
| TOTAL STOCKHOLDERS' EQUITY | 82,755 | 90,192 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 132,054 | $ | 138,521 | ||||
Source: SI-BONE, Inc.