UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
____________________________________________________________________________
FORM 8-K
____________________________________________________________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of report (Date of earliest event reported): May 9, 2022
____________________________________________________________________________
(Exact name of registrant as specified in its charter)
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| (State or other jurisdiction of incorporation or organization) | (Commission File Number) | (I.R.S. Employer Identification No.) | ||||||||||||
(Address of principal executive offices) (Zip Code)
(408 ) 207-0700
(Registrant’s telephone number, include area code)
N/A
(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 | ||||||
| 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 May 9, 2022, SI-BONE, Inc. (the "Company") issued a press release (the “Press Release”) announcing results for the quarter ended March 31, 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.
(d) Exhibits
| Exhibit No. | Description | |||||||
| 99.1 | ||||||||
| 104 | Cover Page Interactive Date File (embedded within the Inline XBRL document) | |||||||
SIGNATURES
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: | May 9, 2022 | By: | /s/ Anshul Maheshwari | ||||||||
| Anshul Maheshwari | |||||||||||
| Chief Financial Officer | |||||||||||
| (Principal Financial and Accounting Officer) | |||||||||||
Exhibit 99.1
SI-BONE, Inc. Reports First Quarter 2022 Financial Results
SANTA CLARA, Calif. May 9, 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 March 31, 2022.
Recent Highlights
•Worldwide revenue of $22.4 million for the first quarter 2022, representing a 10% increase over the corresponding period in 2021
•U.S. revenue of $20.4 million for the first quarter 2022, representing a 9% increase over the corresponding period in 2021
•Gross margin of 87% for the first quarter 2022
•Expanded U.S. commercial organization to 18 sales regions with the addition of 2 new sales regions
•Awarded Breakthrough Device Designation by the FDA for iFuse Bedrock GraniteTM targeting adult spinal deformity
•New Technology Add-on Payment (NTAP) proposed by CMS for iFuse Bedrock GraniteTM
“Our performance in the quarter demonstrates our focused execution to navigate the macro headwinds.” said Laura Francis, Chief Executive Officer of SI-BONE. “As an innovation-driven industry pioneer, we are on the forefront of developing breakthrough sacropelvic surgical solutions to drive top line growth. After the successful launch of TORQ last year, I am extremely proud of the recognition of iFuse Bedrock Granite by the FDA and CMS. Consistent with our long-term value creation strategy, our growing portfolio of highly differentiated solutions positions us to help thousands of patients and extend our leadership as a sacropelvic solutions company."
First Quarter 2022 Financial Results
Worldwide revenue was $22.4 million in the first quarter 2022, a 10% increase from $20.4 million in the corresponding period in 2021. U.S. revenue for the first quarter 2022 was $20.4 million, a 9% increase from $18.8 million in the corresponding period in 2021. International revenue for the first quarter 2022 was $2.1 million, a 24% increase from $1.7 million in the corresponding period in 2021.
Gross margin was 87% for the first quarter 2022, as compared to 89% in the corresponding period in 2021. Gross margin in the first quarter 2022 was impacted by lower average selling prices due to procedure and site of service mix, as well as an increase in cost of operations to support the growth of the business.
Operating expenses increased 22% to $36.3 million in the first quarter 2022, as compared to $29.8 million in the corresponding period in 2021. The increase was driven by higher sales and marketing expenses related to sales force expansion, higher travel costs, research and development investment and increased stock-based compensation.
Operating loss was $16.9 million in the first quarter 2022, as compared to an operating loss of $11.6 million in the corresponding period in 2021.
Net loss was $17.4 million, or $0.52 per diluted share for the first quarter 2022, as compared to a net loss of $12.2 million, or $0.37 per diluted share in the corresponding period in 2021.
Cash and marketable securities were $130.7 million and long-term borrowings were $35.0 million as of March 31, 2022.
2022 Financial Guidance
SI-BONE is encouraged by the strong momentum in the business, but remains cognizant of the uncertainty surrounding COVID-19 and its impact on elective procedures as well as hospital and ASC infrastructure and staffing levels. The Company continues to expect total 2022 revenue of approximately $106 million to $108 million, representing growth of 18% to 20% compared to full year 2021.
Webcast and Conference Call Information
SI-BONE will host a conference call to discuss the first quarter 2022 financial results after market close on Monday, May 9, 2022 at 4:30 P.M. Eastern Time. The conference call can be accessed live over the phone (866) 470-1968 for domestic callers or (409) 217-8248 for international callers, using conference ID: 6088498. The webcast can be accessed at https://investor.si-bone.com.
About SI-BONE, Inc.
SI-BONE (NASDAQ: SIBN) is a global leader in technology for surgical treatment of musculoskeletal disorders of the sacropelvic anatomy. In 2009, SI-BONE introduced the iFuse Implant System for minimally invasive surgery of the SI joint, shown to be a source of pain in 15% to 30% of chronic low back pain. Since then, more than 2,700 surgeons have performed a combined total of more than 65,000 SI joint fusion procedures. A unique body of evidence, supporting the triangular iFuse implant, including two RCT’s and over 100 peer reviewed publications, has enabled multiple government and private insurance payors to establish coverage of the SI joint fusion procedure exclusively when performed with SI-BONE's triangular iFuse implant. SI-BONE is leveraging its market leadership position, supported by this proprietary reimbursement advantage, to commercialize other devices intended for surgical treatment of related aspects of the human anatomy. For more information or to join our team, please visit us at at www.si-bone.com.
For additional information on the company or the products including risks and benefits, please visit www.si-bone.com.
SI-BONE and iFuse Implant System 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 the impact the COVID-19 pandemic will have on the ability and desire of patients and physicians to undergo procedures using the iFuse Implant System, the duration of the COVID-19 pandemic, whether the COVID-19 pandemic will recur in the future, and SI-BONE's ability to increase demand for iFuse. 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
Matt Bacso, CFA
investors@SI-BONE.com
SI-BONE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share amounts)
(Unaudited)
| Three Months Ended March 31, | ||||||||||||||
| 2022 | 2021 | |||||||||||||
Revenue | $ | 22,439 | $ | 20,442 | ||||||||||
Cost of goods sold | 2,983 | 2,200 | ||||||||||||
| Gross profit | 19,456 | 18,242 | ||||||||||||
Operating expenses: | ||||||||||||||
| Sales and marketing | 25,605 | 20,922 | ||||||||||||
| Research and development | 3,580 | 2,955 | ||||||||||||
| General and administrative | 7,139 | 5,940 | ||||||||||||
Total operating expenses | 36,324 | 29,817 | ||||||||||||
Loss from operations | (16,868) | (11,575) | ||||||||||||
Interest and other income (expense), net: | ||||||||||||||
| Interest income | 73 | 61 | ||||||||||||
| Interest expense | (561) | (1,064) | ||||||||||||
| Other income (expense), net | (54) | 336 | ||||||||||||
Net loss | $ | (17,410) | $ | (12,242) | ||||||||||
Net loss per share, basic and diluted | $ | (0.52) | $ | (0.37) | ||||||||||
Weighted-average number of common shares used to compute basic and diluted net loss per share | 33,792,326 | 32,691,578 | ||||||||||||
SI-BONE, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
| March 31, 2022 | December 31, 2021 | ||||||||||
| ASSETS | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 27,329 | $ | 63,419 | |||||||
| Short-term investments | 103,402 | 83,560 | |||||||||
| Accounts receivable, net | 12,682 | 14,246 | |||||||||
| Inventory | 14,705 | 11,498 | |||||||||
| Prepaid expenses and other current assets | 3,143 | 3,143 | |||||||||
| Total current assets | 161,261 | 175,866 | |||||||||
| Property and equipment, net | 10,276 | 8,992 | |||||||||
| Operating lease right-of-use assets | 4,917 | 5,248 | |||||||||
| Other non-current assets | 395 | 400 | |||||||||
| TOTAL ASSETS | $ | 176,849 | $ | 190,506 | |||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | 4,998 | $ | 3,198 | |||||||
| Accrued liabilities and other | 9,169 | 12,353 | |||||||||
| Operating lease liabilities, current portion | 1,286 | 1,339 | |||||||||
| Total current liabilities | 15,453 | 16,890 | |||||||||
| Long-term borrowings | 35,024 | 34,973 | |||||||||
| Operating lease liabilities, net of current portion | 3,889 | 4,166 | |||||||||
| Other long-term liabilities | 45 | 57 | |||||||||
| TOTAL LIABILITIES | 54,411 | 56,086 | |||||||||
| Stockholders' Equity: | |||||||||||
| Common stock and additional paid-in capital | 435,593 | 429,917 | |||||||||
| Accumulated other comprehensive income | 104 | 352 | |||||||||
| Accumulated deficit | (313,259) | (295,849) | |||||||||
| TOTAL STOCKHOLDERS’ EQUITY | 122,438 | 134,420 | |||||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 176,849 | $ | 190,506 | |||||||