SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of report (Date of earliest event reported): November 7, 2022
(Exact name of registrant as specified in its charter)
|Delaware|| ||001-38701|| ||26-2216351|
|(State or other jurisdiction of|
incorporation or organization)
| ||(I.R.S. Employer|
471 El Camino Real
Santa Clara, CA 95050
(Address of principal executive offices) (Zip Code)
(Registrant’s telephone number, include area code)
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
|☐||Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)|
|☐||Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)|
|☐||Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))|
|☐||Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))|Securities registered pursuant to Section 12(b) of the Act:
|Title of each class ||Trading Symbol(s) ||Name of each exchange on which registered |
|Common Stock, par value $0.0001 per share||SIBN||The Nasdaq Global Market|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. Results of Operations and Financial Condition.
On November 7, 2022, SI-BONE, Inc. (the "Company") issued a press release (the “Press Release”) announcing results for the quarter ended September 30, 2022. A copy of the Press Release is attached as Exhibit 99.1 to this current report on Form 8-K and is incorporated by reference herein.
The information under Item 2.02 in this current report on Form 8-K and the related information in the exhibit attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.
Item 9.01. Financial Statements and Exhibits.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| || ||SI-BONE, INC.|
| || || |
|Date:||November 7, 2022||By:||/s/ Anshul Maheshwari|
| || || ||Anshul Maheshwari|
|Chief Financial Officer|
| || || ||(Principal Financial and Accounting Officer)|
SI-BONE, Inc. Reports Financial Results for the Third Quarter 2022 and Updates Guidance
SANTA CLARA, Calif. November 7, 2022 - 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.
•Record worldwide revenue of $26.4 million for the third quarter 2022, representing approximately 19% increase over the corresponding period in 2021
•Record U.S. revenue of $24.6 million for the third quarter 2022, representing approximately 21% 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% and 33% 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 $26.4 million in the third quarter 2022, a 19% increase from $22.3 million in the corresponding period in 2021. U.S. revenue for the third quarter 2022 was $24.6 million, a 21% increase from $20.4 million in the corresponding period in 2021. International revenue for the third quarter 2022 was $1.8 million, a 5% decrease from $1.9 million in the corresponding period in 2021 predominantly driven by headwinds in Germany and the United Kingdom and further foreign exchange weakness.
Gross margin was 84% for the third quarter 2022, as compared to 89% in the corresponding period in 2021. Gross margin in the third quarter 2022 was impacted by lower average selling prices due to procedure, product mix, and site of service mix as well as higher freight. Gross margin also includes the impact of higher costs of the newly
launched implants and higher depreciation from the new product instrument trays to support the growth of the business.
Operating expenses increased 9% to $35.8 million in the third quarter 2022, as compared to $33.0 million in the corresponding period in 2021. The increase was driven by higher headcount, increase in sales commission and stock-based compensation, increase in travel and freight costs, and research and development investment.
Operating loss was $13.6 million in the third quarter 2022, as compared to an operating loss of $13.2 million in the corresponding period in 2021.
Net loss was $14.2 million, or $0.41 per diluted share for the third quarter 2022, as compared to a net loss of $15.9 million, or $0.48 per diluted share in the corresponding period in 2021.
Cash and marketable securities were $104.1 million and borrowings were $35.1 million as of September 30, 2022.
2022 Updated Financial Guidance
The Company expects 2022 worldwide revenue to be in the range of $104 million to $105 million, implying growth of approximately 16% to 17%. The annual revenue guidance implies fourth quarter 2022 worldwide revenue between $29.5 million and $30.5 million, reflecting growth of approximately 17% to 21% over the prior year period.
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.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share amounts)
|Three Months Ended|
|Nine months ended September 30,|
|$||26,432 ||$||22,286 ||$||74,456 ||$||64,922 |
Cost of goods sold
|4,168 ||2,478 ||10,616 ||7,053 |
|Gross profit||22,264 ||19,808 ||63,840 ||57,869 |
|Sales and marketing||25,669 ||23,525 ||80,117 ||67,531 |
|Research and development||3,089 ||3,288 ||10,147 ||9,392 |
|General and administrative||7,072 ||6,194 ||21,891 ||18,685 |
Total operating expenses
|35,830 ||33,007 ||112,155 ||95,608 |
Loss from operations
Interest and other income (expense), net:
|Interest income||346 ||44 ||555 ||151 |
|Other income (expense), net||(183)||(59)||(383)||290 |
Net loss per share, basic and diluted
Weighted-average number of common shares used to compute basic and diluted net loss per share
|34,356,850 ||33,340,093 ||34,069,357 ||33,005,904 |
CONDENSED CONSOLIDATED BALANCE SHEETS
|September 30, 2022||December 31, 2021|
|Cash and cash equivalents||$||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 ||$||190,506 |
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accounts payable||$||4,613 ||$||3,198 |
|Accrued liabilities and other||11,156 ||12,353 |
|Current portion of long-term borrowings||1,458 ||— |
|Operating lease liabilities, current portion||1,337 ||1,339 |
|Total current liabilities||18,564 ||16,890 |
|Long-term borrowings||33,667 ||34,973 |
|Operating lease liabilities, net of current portion||3,175 ||4,166 |
|Other long-term liabilities||31 ||57 |
|TOTAL LIABILITIES||55,437 ||56,086 |
|Common stock and additional paid-in capital||448,601 ||429,917 |
|Accumulated other comprehensive income||157 ||352 |
|TOTAL STOCKHOLDERS’ EQUITY||102,828 ||134,420 |
|TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY||$||158,265 ||$||190,506 |