SI-BONE, Inc. Reports Financial Results for the Third Quarter 2022 and Updates Guidance
SI-BONE, a medical device company, reported Q3 2022 revenue of $26.4 million, a 19% increase year-over-year. U.S. revenue reached $24.6 million, a 21% increase, while international revenue decreased by 5% to $1.8 million.
Gross margin stood at 84%, down from 89% a year earlier, impacted by pricing and cost factors. Operating expenses rose 9% to $35.8 million, leading to an operating loss of $13.6 million. The company maintains a revenue guidance of $104 million to $105 million for 2022, reflecting a growth rate of 16% to 17%.
- Record worldwide revenue of $26.4 million for Q3 2022, a 19% increase year-over-year.
- U.S. revenue of $24.6 million, representing a 21% increase from Q3 2021.
- Gross margin of 84%, indicating strong profitability despite a decline from previous year.
- Over 800 active U.S. surgeons, representing a 27% growth year-over-year.
- FDA clearance for iFuse-TORQ, enhancing product offerings.
- CMS final rule increases 2023 Medicare facility fees significantly.
- International revenue decreased by 5% to $1.8 million due to headwinds in Germany and the UK.
- Operating expenses increased by 9% to $35.8 million, contributing to continued operating losses.
- Operating loss of $13.6 million, slightly higher than the previous year's loss.
SANTA CLARA, Calif., Nov. 07, 2022 (GLOBE NEWSWIRE) -- SI-BONE, Inc. (Nasdaq:SIBN), a medical device company dedicated to solving musculoskeletal disorders of the sacropelvic anatomy, today reported financial results for the quarter ended September 30, 2022.
Recent Highlights
- Record worldwide revenue of
$26.4 million for the third quarter 2022, representing approximately19% increase over the corresponding period in 2021 - Record U.S. revenue of
$24.6 million for the third quarter 2022, representing approximately21% increase over the corresponding period in 2021 - Gross margin of
84% for the third quarter 2022 - Over 800 U.S. active surgeons in the third quarter, representing approximately
27% growth over the corresponding period in 2021 - Received FDA clearance for iFuse-TORQ® to include the Bedrock approach, allowing the promotion of iFuse-TORQ to complement iFuse-Bedrock GraniteTM as a second point of fixation in the Sacro-Alar-Iliac trajectory
- Enrolled first patient in SAFFRON, a prospective randomized clinical trial of surgery using iFuse-TORQ versus non-surgical management in patients with stable but debilitating sacral insufficiency fractures
- CMS final rule increases 2023 Medicare facility fee by approximately
26% and33% for MIS SI joint fusion procedures performed in ASCs and hospital outpatient departments, respectively - Surpassed 75,000 procedures performed by nearly 3,000 surgeons worldwide
“We are encouraged by the continuing top-line acceleration in our business and the increasing operating leverage we were able to generate in the quarter,” said Laura Francis, Chief Executive Officer of SI-BONE. “With a record U.S. active surgeon base and growing surgeon enthusiasm for iFuse-Bedrock Granite, I am energized about the long-term potential for the business. As we look beyond 2022, we remain confident that our seasoned U.S. sales force, combined with favorable reimbursement tailwinds and our best-in-class portfolio positions us to drive growth while increasing operational efficiency and sales force productivity.”
Third Quarter 2022 Financial Results
Worldwide revenue was
Gross margin was
Operating expenses increased
Operating loss was
Net loss was
Cash and marketable securities were
2022 Updated Financial Guidance
The Company expects 2022 worldwide revenue to be in the range of
Webcast Information
SI-BONE will host a conference call to discuss the third quarter 2022 financial results after market close on Monday, November 7, 2022 at 4:30 P.M. Eastern Time. The conference call can be accessed live over webcast at https://edge.media-server.com/mmc/p/cax4w498. Live audio of the webcast will be available on the “Investors” section of the company’s website at: www.si-bone.com. The webcast will be archived and available for replay for at least 90 days after the event.
About SI-BONE, Inc.
SI-BONE (NASDAQ: SIBN) is a global leader in technology for surgical treatment of musculoskeletal disorders of the sacropelvic anatomy. Since 2009, when SI-BONE introduced the iFuse Implant System for minimally invasive surgery of the SI joint, nearly 3,000 surgeons have performed a combined total of more than 75,000 SI joint fusion procedures. A unique body of evidence, supporting the iFuse Implant System, including two randomized controlled trials and over 100 peer reviewed publications, has enabled multiple government and private insurance payors to establish near-universal coverage of minimally invasive SI joint fusion, including many payors that cover the procedure exclusively when performed with the iFuse Implant System. Supported by this proprietary reimbursement advantage, SI-BONE has actively leveraged its market leadership position in recent years to further clinical research, and evolve and commercialize novel surgical treatment solutions for SI-Joint pain, sacropelvic and pelvic fixation, and pelvic trauma.
For additional information on the company or the products including risks and benefits, please visit www.si-bone.com.
SI-BONE, iFuse Implant System and iFuse-TORQ are registered trademarks of SI-BONE, Inc. ©2022 SI-BONE, Inc. All Rights Reserved.
Forward Looking Statements
The statements in this press release regarding expectations of future events or results, including SI-BONE’s expectations of continued growth and financial outlook, contained in this press release are "forward-looking" statements. These forward-looking statements are based on SI-BONE's current expectations and inherently involve significant risks and uncertainties. These risks include SI-BONE's ability to introduce and commercialize new products and indications, SI-BONE's ability to maintain favorable reimbursement for procedures using its products, the impact of future fluctuations in currency exchange rates on SI-BONE's revenues, SI-BONE's ability to manage risks to its supply chain, future capital requirements driven by new surgical systems requiring instrument tray investment, and the future impact the COVID-19 pandemic will have on the ability and desire of patients and physicians to undergo procedures using the iFuse Implant System. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these and other risks and uncertainties, many of which are described in the company's most recent filings on Form 10-K and Form 10-Q, and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov), especially under the caption "Risk Factors". SI-BONE does not undertake any obligation to update forward-looking statements and expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein, except as required by law.
Investor Contact
Marissa Bych
investors@SI-BONE.com
SI-BONE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share amounts)
(Unaudited)
| Three Months Ended September 30, | Nine months ended September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenue | $ | 26,432 | $ | 22,286 | $ | 74,456 | $ | 64,922 | ||||||||
| Cost of goods sold | 4,168 | 2,478 | 10,616 | 7,053 | ||||||||||||
| Gross profit | 22,264 | 19,808 | 63,840 | 57,869 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Sales and marketing | 25,669 | 23,525 | 80,117 | 67,531 | ||||||||||||
| Research and development | 3,089 | 3,288 | 10,147 | 9,392 | ||||||||||||
| General and administrative | 7,072 | 6,194 | 21,891 | 18,685 | ||||||||||||
| Total operating expenses | 35,830 | 33,007 | 112,155 | 95,608 | ||||||||||||
| Loss from operations | (13,566 | ) | (13,199 | ) | (48,315 | ) | (37,739 | ) | ||||||||
| Interest and other income (expense), net: | ||||||||||||||||
| Interest income | 346 | 44 | 555 | 151 | ||||||||||||
| Interest expense | (755 | ) | (2,658 | ) | (1,938 | ) | (4,797 | ) | ||||||||
| Other income (expense), net | (183 | ) | (59 | ) | (383 | ) | 290 | |||||||||
| Net loss | $ | (14,158 | ) | $ | (15,872 | ) | $ | (50,081 | ) | $ | (42,095 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.41 | ) | $ | (0.48 | ) | $ | (1.47 | ) | $ | (1.28 | ) | ||||
| Weighted-average number of common shares used to compute basic and diluted net loss per share | 34,356,850 | 33,340,093 | 34,069,357 | 33,005,904 | ||||||||||||
SI-BONE, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
| September 30, 2022 | December 31, 2021 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 26,299 | $ | 63,419 | ||||
| Short-term investments | 77,785 | 83,560 | ||||||
| Accounts receivable, net | 16,453 | 14,246 | ||||||
| Inventory | 16,852 | 11,498 | ||||||
| Prepaid expenses and other current assets | 1,791 | 3,143 | ||||||
| Total current assets | 139,180 | 175,866 | ||||||
| Property and equipment, net | 14,449 | 8,992 | ||||||
| Operating lease right-of-use assets | 4,251 | 5,248 | ||||||
| Other non-current assets | 385 | 400 | ||||||
| TOTAL ASSETS | $ | 158,265 | $ | 190,506 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,613 | $ | 3,198 | ||||
| Accrued liabilities and other | 11,156 | 12,353 | ||||||
| Current portion of long-term borrowings | 1,458 | — | ||||||
| Operating lease liabilities, current portion | 1,337 | 1,339 | ||||||
| Total current liabilities | 18,564 | 16,890 | ||||||
| Long-term borrowings | 33,667 | 34,973 | ||||||
| Operating lease liabilities, net of current portion | 3,175 | 4,166 | ||||||
| Other long-term liabilities | 31 | 57 | ||||||
| TOTAL LIABILITIES | 55,437 | 56,086 | ||||||
| Stockholders' Equity: | ||||||||
| Common stock and additional paid-in capital | 448,601 | 429,917 | ||||||
| Accumulated other comprehensive income | 157 | 352 | ||||||
| Accumulated deficit | (345,930 | ) | (295,849 | ) | ||||
| TOTAL STOCKHOLDERS’ EQUITY | 102,828 | 134,420 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 158,265 | $ | 190,506 | ||||
FAQ
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