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): August 8, 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 August 8, 2022, SI-BONE, Inc. (the "Company") issued a press release (the “Press Release”) announcing results for the quarter ended June 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.
(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: | August 8, 2022 | By: | /s/ Anshul Maheshwari | ||||||||
| Anshul Maheshwari | |||||||||||
| Chief Financial Officer | |||||||||||
| (Principal Financial and Accounting Officer) | |||||||||||
Exhibit 99.1
SI-BONE, Inc. Reports Financial Results for the Second Quarter 2022
SANTA CLARA, Calif. August 8, 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 June 30, 2022.
Recent Highlights
•Record worldwide revenue of $25.6 million for the second quarter 2022, representing approximately 15% increase over the corresponding period in 2021
•Record U.S. revenue of $23.8 million for the second quarter 2022, representing approximately 18% increase over the corresponding period in 2021
•Gross margin of 86% for the second quarter 2022
•Received FDA clearance for an expanded indication for iFuse-TORQ® which includes use of the device in pelvic fragility and insufficiency fractures
•Received FDA clearance for iFuse Bedrock GraniteTM, a breakthrough device targeting adult spinal deformity
•Received final decision from CMS confirming up to $9,828 in Medicare new technology add-on payment (NTAP) for eligible cases using iFuse Bedrock Granite, effective October 1, 2022
•Completed patient enrollment for SILVIA, a two-year prospective international multi-center randomized controlled trial of two different methods for pelvic fixation in adult patients
•Surpassed 70,000 procedures performed by over 2,800 surgeons worldwide
•CMS proposed rule for 2023 for primary MIS SI joint fusion indicating a 28% and 35% increase in ASC and hospital outpatient facility fees, respectively
“I am pleased with the accelerating growth in the U.S. which allowed us to deliver record revenue in the quarter with iFuse-3D and iFuse-TORQ as the two best products on the market for MIS SI joint fusion,” said Laura Francis, Chief Executive Officer of SI-BONE. “The recent launch of iFuse Bedrock Granite and the expanded trauma indication for iFuse-TORQ will complement our core market growth as we support our surgeons in improving patient outcomes across modalities. With the best-in-class portfolio of sacropelvic solutions, an industry-leading commercial infrastructure and a strong cash position, we have the organizational resources to capitalize on the healthy demand dynamics and deliver accelerating top line growth.”
Second Quarter 2022 Financial Results
Worldwide revenue was $25.6 million in the second quarter 2022, a 15% increase from $22.2 million in the corresponding period in 2021. U.S. revenue for the second quarter 2022 was $23.8 million, a 18% increase from $20.2 million in the corresponding period in 2021. International revenue for the second quarter 2022 was $1.8 million, a 8% decrease from $2.0 million in the corresponding period in 2021 predominantly driven by unfavorable foreign exchange.
Gross margin was 86% for the second quarter 2022, as compared to 89% in the corresponding period in 2021. Gross margin in the second 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 including costs related to new product launches.
Operating expenses increased 22% to $40.0 million in the second quarter 2022, as compared to $32.8 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 $17.9 million in the second quarter 2022, as compared to an operating loss of $13.0 million in the corresponding period in 2021.
Net loss was $18.5 million, or $0.54 per diluted share for the second quarter 2022, as compared to a net loss of $14.0 million, or $0.42 per diluted share in the corresponding period in 2021.
Cash and marketable securities were $114.4 million and long-term borrowings were $35.1 million as of June 30, 2022.
2022 Financial Guidance
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. The Company continues to expect gross margin to be in the mid-80 percent range for fiscal year 2022.
Webcast and Conference Call Information
SI-BONE will host a conference call to discuss the second quarter 2022 financial results after market close on Monday, August 8, 2022 at 4:30 P.M. Eastern Time. The conference call can be accessed live over the phone (888) 346-8835 for domestic callers or (412) 902-6646 for international callers. 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. Since 2009, when SI-BONE introduced the iFuse Implant System for minimally invasive surgery of the SI joint, more than 2,800 surgeons have performed a combined total of more than 70,000 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 the SI joint fusion procedure. 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 more information or to join our team, please visit us 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 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 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
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 June 30, | Six months ended June 30, | ||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
Revenue | $ | 25,585 | $ | 22,194 | $ | 48,024 | $ | 42,636 | |||||||||||||||
Cost of goods sold | 3,465 | 2,375 | 6,448 | 4,575 | |||||||||||||||||||
| Gross profit | 22,120 | 19,819 | 41,576 | 38,061 | |||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||
| Sales and marketing | 28,843 | 23,084 | 54,448 | 44,006 | |||||||||||||||||||
| Research and development | 3,478 | 3,149 | 7,058 | 6,104 | |||||||||||||||||||
| General and administrative | 7,680 | 6,551 | 14,819 | 12,491 | |||||||||||||||||||
Total operating expenses | 40,001 | 32,784 | 76,325 | 62,601 | |||||||||||||||||||
Loss from operations | (17,881) | (12,965) | (34,749) | (24,540) | |||||||||||||||||||
Interest and other income (expense), net: | |||||||||||||||||||||||
| Interest income | 136 | 46 | 209 | 107 | |||||||||||||||||||
| Interest expense | (622) | (1,075) | (1,183) | (2,139) | |||||||||||||||||||
| Other income (expense), net | (146) | 13 | (200) | 349 | |||||||||||||||||||
Net loss | $ | (18,513) | $ | (13,981) | $ | (35,923) | $ | (26,223) | |||||||||||||||
Net loss per share, basic and diluted | $ | (0.54) | $ | (0.42) | $ | (1.06) | $ | (0.80) | |||||||||||||||
Weighted-average number of common shares used to compute basic and diluted net loss per share | 34,052,692 | 32,978,914 | 33,923,229 | 32,836,040 | |||||||||||||||||||
SI-BONE, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
| June 30, 2022 | December 31, 2021 | ||||||||||
| ASSETS | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 24,319 | $ | 63,419 | |||||||
| Short-term investments | 90,095 | 83,560 | |||||||||
| Accounts receivable, net | 15,118 | 14,246 | |||||||||
| Inventory | 16,484 | 11,498 | |||||||||
| Prepaid expenses and other current assets | 2,325 | 3,143 | |||||||||
| Total current assets | 148,341 | 175,866 | |||||||||
| Property and equipment, net | 12,810 | 8,992 | |||||||||
| Operating lease right-of-use assets | 4,611 | 5,248 | |||||||||
| Other non-current assets | 385 | 400 | |||||||||
| TOTAL ASSETS | $ | 166,147 | $ | 190,506 | |||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | 5,141 | $ | 3,198 | |||||||
| Accrued liabilities and other | 10,189 | 12,353 | |||||||||
| Operating lease liabilities, current portion | 1,342 | 1,339 | |||||||||
| Total current liabilities | 16,672 | 16,890 | |||||||||
| Long-term borrowings | 35,075 | 34,973 | |||||||||
| Operating lease liabilities, net of current portion | 3,529 | 4,166 | |||||||||
| Other long-term liabilities | 38 | 57 | |||||||||
| TOTAL LIABILITIES | 55,314 | 56,086 | |||||||||
| Stockholders' Equity: | |||||||||||
| Common stock and additional paid-in capital | 435,593 | 429,917 | |||||||||
| Accumulated other comprehensive income | 32 | 352 | |||||||||
| Accumulated deficit | (331,772) | (295,849) | |||||||||
| TOTAL STOCKHOLDERS’ EQUITY | 110,833 | 134,420 | |||||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 166,147 | $ | 190,506 | |||||||