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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark one)
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2025
OR
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from __________ to __________
Commission File Number: 001-38701
SI-BONE, INC.
(Exact Name of Registrant as Specified in its Charter)
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Delaware | | 26-2216351 |
(State or Other Jurisdiction of Incorporation or Organization) | | (I.R.S. Employer Identification Number) |
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471 El Camino Real, Suite 101, Santa Clara, California | | 95050 |
(Address of principal executive offices) | | (Zip Code) |
Registrant's telephone number, including area code: (408) 207-0700
Securities registered pursuant to Section 12(b) of the Act:
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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 (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filer | ☐ | | Accelerated filer | ☒ | | Non-accelerated filer | ☐ |
Smaller reporting company | ☐ | | 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 7(a)(2)(B) of the Securities Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No x
The number of shares outstanding of the registrant’s Common Stock was 42,614,514 as of April 30, 2025.
TABLE OF CONTENTS
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| | PART I-FINANCIAL INFORMATION | |
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| | PART II-OTHER INFORMATION | |
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements. All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding our future results of operations and financial position, business strategy, prospective products and product candidates, sales force expansion, physician adoption, reimbursement determinations, clinical trial results, and U.S. Food and Drug Administration ("FDA") approvals, are forward-looking statements.
These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.
In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements speak only as of the date of this Quarterly Report and are subject to a number of risks, uncertainties and assumptions, including those described under the sections in this Quarterly Report titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” These forward-looking statements include, but are not limited to, statements about the following:
•our expectation that a significant portion of our revenue will be derived from sales of similar products addressing the sacropelvic anatomy;
•our ability to develop and commercialize additional revenue opportunities, including new indications for use and new products;
•our ability to retain and grow our sales team based on the demand for our products;
•our ability to identify, train, and retain physicians to perform procedures using our products;
•our ability to obtain and maintain favorable coverage and reimbursement determinations from third-party payors;
•our estimates of our market opportunity;
•our expectations regarding the scope of protection from intellectual property rights covering our products;
•developments or disputes concerning our intellectual property or other proprietary rights;
•timing of and results from our clinical trials and other studies;
•marketing clearances and authorization from the FDA and regulators in other jurisdictions and CE Certificates of Conformity from Notified Bodies;
•timing of regulatory filings and feedback;
•competition in the markets we serve;
•our expectations of the reliability and performance of our products;
•our expectations of the benefits of our products to patients, providers, and payors;
•the impact of proposed tariffs on our business, including the impact on gross margins related to our international product sales and the impact of resulting economic uncertainty on demand for our products;
•factors impacting the supply chains we rely on, including tariffs and the availability of raw materials and skilled labor serving our suppliers, and the cost of these factors of production which may in turn impact the prices we pay for our devices;
•our reliance on a limited number of suppliers, including sole source suppliers, which may impact the availability of instruments and materials;
•our ability to sustain or increase demand for our products;
•our estimates regarding our costs and risks associated with our international operations and expansion;
•our expectations regarding our ability to retain and recruit key personnel;
•our ability to attract and retain employees, including those with specialized skills and experience;
•our expectations regarding acquisitions and strategic operations;
•our ability to access capital markets;
•our ability to fund our working capital requirements;
•our compliance with, and the cost of, federal, state, and foreign regulatory requirements;
•the factors that may impact our financial results; and
•anticipated trends and challenges in our business and the markets in which we operate.
Forward-looking statements are based on management’s current expectations, estimates, forecasts, and projections about our business and the industry in which we operate, and management’s beliefs and assumptions are not guarantees of future performance or development and involve known and unknown risks, uncertainties, and other factors that are in some cases beyond our control. As a result, any or all of our forward-looking statements in this report may turn out to be inaccurate. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report on Form 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements.
Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, together with any updates in the section titled “Risk Factors” in this Quarterly Report on Form 10-Q. These statements, like all statements in this report, speak only as of their date. We caution investors that our business and financial performance are subject to substantial risks and uncertainties. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future, except as may be required by law.
PART I-FINANCIAL INFORMATION
Item 1. Financial Statements
SI-BONE, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
(Unaudited)
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| March 31, 2025 | | December 31, 2024 |
ASSETS | | | |
Current assets: | | | |
Cash and cash equivalents | $ | 41,187 | | | $ | 34,948 | |
Short-term investments | 103,227 | | | 115,094 | |
Accounts receivable, net of allowance for credit losses of $591 and $588, respectively | 26,705 | | | 27,459 | |
Inventory | 30,379 | | | 27,074 | |
Prepaid expenses and other current assets | 2,704 | | | 3,204 | |
Total current assets | 204,202 | | | 207,779 | |
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Property and equipment, net | 21,074 | | | 20,374 | |
Operating lease right-of-use assets | 1,702 | | | 1,984 | |
Other non-current assets | 302 | | | 300 | |
TOTAL ASSETS | $ | 227,280 | | | $ | 230,437 | |
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LIABILITIES AND STOCKHOLDERS’ EQUITY | | | |
Current liabilities: | | | |
Accounts payable | $ | 7,705 | | | $ | 6,488 | |
Accrued liabilities and other | 15,157 | | | 19,492 | |
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Operating lease liabilities, current portion | 1,090 | | | 1,152 | |
Total current liabilities | 23,952 | | | 27,132 | |
Long-term borrowings | 35,481 | | | 35,452 | |
Operating lease liabilities, net of current portion | 583 | | | 879 | |
Other long-term liabilities | — | | | 10 | |
TOTAL LIABILITIES | 60,016 | | | 63,473 | |
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Commitments and contingencies (Note 6) | | | |
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STOCKHOLDERS’ EQUITY | | | |
Preferred stock, $0.0001 par value; 5,000,000 shares authorized; no shares issued and outstanding | — | | | — | |
Common stock, $0.0001 par value; 100,000,000 shares authorized; 42,479,600 and 42,086,477 shares issued and outstanding, respectively | 4 | | | 4 | |
Additional paid-in capital | 604,836 | | | 598,070 | |
Accumulated other comprehensive income | 320 | | | 244 | |
Accumulated deficit | (437,896) | | | (431,354) | |
TOTAL STOCKHOLDERS’ EQUITY | 167,264 | | | 166,964 | |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 227,280 | | | $ | 230,437 | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
SI-BONE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
(Unaudited)
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| Three Months Ended March 31, | | | | |
| 2025 | | 2024 | | | | | | | | |
Revenue | $ | 47,290 | | | $ | 37,867 | | | | | | | | | |
Cost of goods sold | 9,595 | | | 8,002 | | | | | | | | | |
Gross profit | 37,695 | | | 29,865 | | | | | | | | | |
Operating expenses: | | | | | | | | | | | |
Sales and marketing | 30,681 | | | 29,387 | | | | | | | | | |
Research and development | 4,534 | | | 4,345 | | | | | | | | | |
General and administrative | 9,960 | | | 8,176 | | | | | | | | | |
Total operating expenses | 45,175 | | | 41,908 | | | | | | | | | |
Loss from operations | (7,480) | | | (12,043) | | | | | | | | | |
Interest and other income (expense), net: | | | | | | | | | | | |
Interest income | 1,592 | | | 2,113 | | | | | | | | | |
Interest expense | (662) | | | (881) | | | | | | | | | |
Other income (expense) | 8 | | | (93) | | | | | | | | | |
Net loss | $ | (6,542) | | | $ | (10,904) | | | | | | | | | |
Other comprehensive income (loss): | | | | | | | | | | | |
Changes in foreign currency translation | 157 | | | 29 | | | | | | | | | |
Unrealized loss on marketable securities | (81) | | | (98) | | | | | | | | | |
Comprehensive loss | $ | (6,466) | | | $ | (10,973) | | | | | | | | | |
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Net loss per share, basic and diluted | $ | (0.15) | | | $ | (0.27) | | | | | | | | | |
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Weighted-average number of common shares used to compute basic and diluted net loss per share | 42,337,481 | | | 40,934,392 | | | | | | | | | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
SI-BONE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY
(In thousands, except share amounts)
(Unaudited) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Common Stock | | Additional Paid-in Capital | | Accumulated Other Comprehensive Income | | Accumulated Deficit | | Total Stockholders’ Equity | | |
| | Shares | | Amount | | | | | | |
Balance as of December 31, 2024 | | 42,086,477 | | | $ | 4 | | | $ | 598,070 | | | $ | 244 | | | $ | (431,354) | | | $ | 166,964 | | | |
Issuance of common stock upon exercise of stock options, net of shares withheld | | 20,045 | | | — | | | 103 | | | — | | | — | | | 103 | | | |
Issuance of common stock upon vesting of restricted stock units | | 373,078 | | | — | | | — | | | — | | | — | | | — | | | |
Stock-based compensation | | — | | | — | | | 6,663 | | | — | | | — | | | 6,663 | | | |
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Foreign currency translation | | — | | | — | | | — | | | 157 | | | — | | | 157 | | | |
Net unrealized loss on marketable securities | | — | | | — | | | — | | | (81) | | | — | | | (81) | | | |
Net loss | | — | | | — | | | — | | | — | | | (6,542) | | | (6,542) | | | |
Balance as of March 31, 2025 | | 42,479,600 | | | $ | 4 | | | $ | 604,836 | | | $ | 320 | | | $ | (437,896) | | | $ | 167,264 | | | |
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| | Common Stock | | Additional Paid-in Capital | | Accumulated Other Comprehensive Income | | Accumulated Deficit | | Total Stockholders’ Equity | | |
| | Shares | | Amount | | | | | | |
Balance as of December 31, 2023 | | 40,693,299 | | | $ | 4 | | | $ | 569,477 | | | $ | 335 | | | $ | (400,441) | | | $ | 169,375 | | | |
Issuance of common stock upon exercise of stock options, net of shares withheld | | 29,892 | | | — | | | 105 | | | — | | | — | | | 105 | | | |
Issuance of common stock upon vesting of restricted stock units | | 355,571 | | | — | | | — | | | — | | | — | | | — | | | |
Stock-based compensation | | — | | | — | | | 7,030 | | | — | | | — | | | 7,030 | | | |
Foreign currency translation | | — | | | — | | | — | | | 29 | | | — | | | 29 | | | |
Net unrealized loss on marketable securities | | — | | | — | | | — | | | (98) | | | — | | | (98) | | | |
Net loss | | — | | | — | | | — | | | — | | | (10,904) | | | (10,904) | | | |
Balance as of March 31, 2024 | | 41,078,762 | | | $ | 4 | | | $ | 576,612 | | | $ | 266 | | | $ | (411,345) | | | $ | 165,537 | | | |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
SI-BONE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited) | | | | | | | | | | | |
| Three Months Ended March 31, |
| 2025 | | 2024 |
Cash flows from operating activities | | | |
Net loss | $ | (6,542) | | | $ | (10,904) | |
Adjustments to reconcile net loss to net cash used in operating activities: | | | |
Stock-based compensation | 6,663 | | | 7,030 | |
Depreciation and amortization | 1,278 | | | 1,089 | |
Accounts receivable credit losses | 91 | | | 82 | |
Amortization of discount and premium on marketable securities | (916) | | | (1,561) | |
Inventory reserve | 394 | | | — | |
Amortization of debt issuance costs | 29 | | | 42 | |
| | | |
Loss on disposal of property and equipment | 287 | | | 388 | |
Changes in operating assets and liabilities: | | | |
Accounts receivable | 552 | | | (196) | |
Inventory | (3,767) | | | (772) | |
Prepaid expenses and other assets | 494 | | | 524 | |
Accounts payable | 952 | | | 2,371 | |
Accrued liabilities and other | (4,426) | | | (5,664) | |
Net cash used in operating activities | (4,911) | | | (7,571) | |
Cash flows from investing activities | | | |
Maturities of marketable securities | 60,000 | | | 67,000 | |
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Purchases of marketable securities | (47,298) | | | (58,571) | |
Purchases of property and equipment | (2,072) | | | (2,082) | |
Net cash provided by investing activities | 10,630 | | | 6,347 | |
Cash flows from financing activities | | | |
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Proceeds from the exercise of stock options | 103 | | | 105 | |
Net cash provided by financing activities | 103 | | | 105 | |
Effect of exchange rate changes on cash and cash equivalents | 417 | | | (112) | |
Net increase (decrease) in cash and cash equivalents | 6,239 | | | (1,231) | |
Cash and cash equivalents at | | | |
Beginning of period | 34,948 | | | 33,271 | |
End of period | $ | 41,187 | | | $ | 32,040 | |
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Supplemental disclosure of non-cash information | | | |
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Unpaid purchases of property and equipment | 815 | | | 1,228 | |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
SI-BONE, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)
1. The Company and Nature of Business
SI-BONE, Inc. (the “Company”) was incorporated in the state of Delaware on March 18, 2008 and is headquartered in Santa Clara, California. The Company is a medical device company that has pioneered a proprietary minimally invasive surgical implant system to fuse the sacroiliac joint for treatment of musculoskeletal disorders of the sacropelvic anatomy. The Company’s products include a series of patented titanium implants and the instruments used to implant them, as well as implantable bone products. Since launching its first generation iFuse in 2009, the Company has launched multiple titanium implant product lines, including iFuse-3D in 2017, iFuse TORQ in 2021, iFuse Bedrock Granite in 2022, and iFuse INTRA and iFuse TORQ TNT in 2024. In the United States, iFuse, iFuse-3D, iFuse TORQ and iFuse Bedrock Granite have clearances for applications in sacroiliac joint dysfunction, adult spinal deformity and pelvic trauma. iFuse TORQ TNT has clearances for applications in pelvic trauma and sacroiliac joint dysfunction.
2. Summary of Significant Accounting Policies
Basis of Presentation and Principles of Consolidation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) and applicable rules and regulations of the Securities and Exchange Commission (“SEC”) regarding interim financial reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP have been condensed or omitted, and accordingly the balance sheet as of December 31, 2024 has been derived from the audited consolidated financial statements at that date but does not include all of the information required by U.S. GAAP for complete financial statements. These unaudited interim condensed consolidated financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments that are necessary for a fair statement of the Company’s consolidated financial information. The results of operations for the three months ended March 31, 2025 are not necessarily indicative of the results to be expected for the year ending December 31, 2025 or for any other interim period or for any other future year.
The accompanying condensed consolidated financial statements should be read in conjunction with the audited financial statements and related notes thereto for the year ended December 31, 2024 contained in the Company’s Annual Report on Form 10-K filed with the SEC on February 25, 2025 (the “2024 Annual Report”).
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Significant accounting estimates and management judgments reflected in the condensed consolidated financial statements primarily includes the fair value of performance-based restricted stock unit awards. Estimates are based on historical experience, where applicable and other assumptions believed to be reasonable by the management. Actual results could differ from those estimates.
Significant Accounting Policies
The Company’s significant accounting policies are disclosed in the 2024 Annual Report. There have been no material changes to these accounting policies.
Segments
The Company's chief operating decision makers (“CODMs”) are the Chief Executive Officer and Chief Financial Officer. The Company has determined that it has a single operating and reportable segment. The CODMs use revenue and net loss at the consolidated level to measure segment profit and loss, allocate resources, monitor plan versus actual results, and manage operations. Significant expenses within net loss include cost of goods sold, sales and marketing, research and development, and general and administrative at the consolidated level. Other segment items within net loss include interest income, interest expense, and other income (expense), net.
Substantially all of the segment revenue is derived from sales to customers in the U.S. Description of segment products are included in Note 1. The Company and Nature of Business. Revenue by geography is based on billing address of the customer. International revenue accounted for less than 10% of the total revenue during the periods presented. Long-lived assets held outside the U.S. are immaterial. The following table summarizes the Company's revenue by geography:
SI-BONE, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)
| | | | | | | | | | | | | | | | | | |
| Three Months Ended March 31, | | | |
| 2025 | | 2024 | | | | | | | |
| (in thousands) |
United States | $ | 44,836 | | | $ | 35,425 | | | | | | | | |
International | 2,454 | | | 2,442 | | | | | | | | |
| $ | 47,290 | | | $ | 37,867 | | | | | | | | |
Recent Accounting Pronouncements
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures ("ASU 2023-09"). ASU 2023-09 requires public business entities to disclose additional information in specified categories with respect to the reconciliation of the effective tax rate to the statutory rate (the rate reconciliation) for federal, state, and foreign income taxes. It also requires greater detail about individual reconciling items in the rate reconciliation to the extent the impact of those items exceeds a specified threshold. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024. The Company is currently evaluating the impacts of ASU 2023-09 on its disclosures.
In November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (“ASU 2024-03”). ASU 2024-03 requires disclosure in the notes to the financial statements of specified information about certain costs and expenses. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026 and for interim periods within fiscal years beginning after December 15, 2027. ASU 2024-03 should be applied either prospectively to financial statements issued for reporting periods after the effective date of this ASU or retrospectively to any or all prior periods presented in the financial statements. The Company is currently evaluating the impact of ASU 2024-03 on its disclosures.
SI-BONE, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)
3. Marketable Securities
All of the Company's marketable securities were available-for-sale and were classified based on their maturities. Marketable securities with remaining maturities at the date of purchase of three months or less are classified as cash equivalents. Short-term investments are securities that original maturity or remaining maturity is greater than three months and not more than twelve months. Long-term investments are securities for which the original maturity or remaining maturity is greater than twelve months.
The table below summarizes the marketable securities:
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| March 31, 2025 |
| Amortized Cost | | Unrealized Gains | | Unrealized Losses | | Aggregate Fair Value |
| (in thousands) |
Money market funds | $ | 34,515 | | | $ | — | | | $ | — | | | $ | 34,515 | |
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Cash equivalents | 34,515 | | | — | | | — | | | 34,515 | |
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U.S. treasury securities | 100,866 | | | 16 | | | (6) | | | 100,876 | |
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U.S. agency bonds | 2,351 | | | — | | | — | | | 2,351 | |
Short-term investments | 103,217 | | | 16 | | | (6) | | | 103,227 | |
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Total marketable securities | $ | 137,732 | | | $ | 16 | | | $ | (6) | | | $ | 137,742 | |
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| December 31, 2024 |
| Amortized Cost | | Unrealized Gains | | Unrealized Losses | | Aggregate Fair Value |
| (in thousands) |
Money market funds | $ | 27,326 | | | $ | — | | | $ | — | | | $ | 27,326 | |
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Cash equivalents | 27,326 | | | — | | | — | | | 27,326 | |
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U.S. treasury securities | 112,649 | | | 91 | | | (2) | | | 112,738 | |
U.S. agency bonds | 2,355 | | | 1 | | | — | | | 2,356 | |
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Short-term investments | 115,004 | | | 92 | | | (2) | | | 115,094 | |
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Total marketable securities | $ | 142,330 | | | $ | 92 | | | $ | (2) | | | $ | 142,420 | |
The amortized cost of the Company's available-for-sale securities approximates their fair value. Unrealized losses are generally due to interest rate fluctuations, as opposed to credit quality. However, the Company reviews individual securities that are in an unrealized loss position in order to evaluate whether or not they have experienced or are expected to experience credit losses. As of March 31, 2025 and December 31, 2024, unrealized gains and losses from the investments were not the result of a decline in credit quality. As a result, the Company did not recognize any credit losses related to its investments and that all unrealized gains and losses on available-for-sale securities are recorded in accumulated other comprehensive income (loss) on the condensed consolidated balance sheets as of March 31, 2025 and December 31, 2024.
The Company elected to present accrued interest receivable separately from short-term investments on its condensed consolidated balance sheets. Accrued interest receivable were $0.4 million and $0.3 million as of March 31, 2025 and December 31, 2024, respectively, and was recorded in prepaid expenses and other current assets. The Company also elected to exclude accrued interest receivable from the estimation of expected credit losses on its marketable securities and reverse accrued interest receivable through interest income (expense) when amounts are determined to be uncollectible. The Company did not write off any accrued interest receivable during the three months ended March 31, 2025 or year ended December 31, 2024.
SI-BONE, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)
4. Fair Value Measurement
Carrying amounts of certain of the Company’s financial instruments, including cash equivalents, accounts receivable, accounts payable and accrued liabilities, approximate fair value due to their relatively short maturities and market interest rates, if applicable. The carrying value of the Company’s long-term debt also approximates fair value based on management’s estimation that a current interest rate would not differ materially from the stated rate. There were no other financial assets and liabilities that require fair value hierarchy measurements and disclosures for the periods presented.
The table below summarizes the fair value of the Company’s marketable securities measured at fair value on a recurring basis based on the three-tier fair value hierarchy:
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| March 31, 2025 |
| Level 1 | | Level 2 | | Level 3 | | Total |
| (in thousands) |
Marketable securities | | | | | | | |
Money market funds | $ | 34,515 | | | $ | — | | | $ | — | | | $ | 34,515 | |
U.S. treasury securities | 100,876 | | | — | | | — | | | 100,876 | |
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U.S. agency bonds | — | | | 2,351 | | | — | | | 2,351 | |
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Total marketable securities | $ | 135,391 | | | $ | 2,351 | | | $ | — | | | $ | 137,742 | |
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| December 31, 2024 |
| Level 1 | | Level 2 | | Level 3 | | Total |
| (in thousands) |
Marketable securities | | | | | | | |
Money market funds | $ | 27,326 | | | $ | — | | | $ | — | | | $ | 27,326 | |
U.S. treasury securities | 112,738 | | | — | | | — | | | 112,738 | |
U.S. agency bonds | — | | | 2,356 | | | — | | | 2,356 | |
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Total marketable securities | $ | 140,064 | | | $ | 2,356 | | | $ | — | | | $ | 142,420 | |
SI-BONE, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)
5. Balance Sheet Components
Inventory
As of March 31, 2025, inventory consisted of finished goods of $26.4 million and work-in-progress and components of $4.0 million. As of December 31, 2024, inventory consisted of finished goods of $24.0 million and work-in-progress and components of $3.1 million.
Property and Equipment, net:
| | | | | | | | | | | |
| March 31, 2025 | | December 31, 2024 |
| (in thousands) |
Instrument trays | $ | 24,431 | | | $ | 23,158 | |
Machinery and equipment | 3,167 | | | 3,188 | |
Construction in progress | 6,926 | | | 6,212 | |
Computer and office equipment | 3,124 | | | 3,098 | |
Leasehold improvements | 3,873 | | | 3,873 | |
Furniture and fixtures | 388 | | | 386 | |
| 41,909 | | | 39,915 | |
Less: Accumulated depreciation and amortization | (20,835) | | | (19,541) | |
| $ | 21,074 | | | $ | 20,374 | |
As of March 31, 2025, construction in progress pertains to the cost of individual components of an instrument tray used for surgical placement of the Company's products that have not yet been placed into service of $5.9 million and software costs of $1.0 million. As of December 31, 2024, construction in progress pertains to cost of individual components of an instrument tray used for surgical placement of the Company's products that have not yet been placed into service of $5.6 million and software costs of $0.6 million. Depreciation expense was $1.3 million and $1.1 million for the three months ended March 31, 2025 and 2024, respectively.
Accrued Liabilities and Other:
| | | | | | | | | | | |
| March 31, 2025 | | December 31, 2024 |
| (in thousands) |
Accrued compensation and related expenses | $ | 9,771 | | | $ | 13,914 | |
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Accrued royalty | 2,027 | | | 2,054 | |
Accrued rebates | 1,190 | | | 1,384 | |
Accrued professional services | 1,125 | | | 1,202 | |
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Others | 1,044 | | | 938 | |
| $ | 15,157 | | | $ | 19,492 | |
Accounts Receivable and Allowance for Credit Losses:
The movement in the allowance for credit losses was as follows:
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| March 31, 2025 | | December 31, 2024 |
| (in thousands) |
Balance at beginning of period | $ | 588 | | | $ | 1,118 | |
Provision | 91 | | | 470 | |
Write-offs | (88) | | | (1,000) | |
Balance at end of period | $ | 591 | | | $ | 588 | |
SI-BONE, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)
6. Commitments and Contingencies
Operating Leases
The Company has a non-cancelable operating lease for an office building space, located in Santa Clara, California, with an original lease period expiring in May 2025. On July 18, 2024, the Company extended the term of the lease for an additional period of fourteen months commencing on June 1, 2025 and expiring July 31, 2026.
The Company also has non-cancelable leases for a building used for research and development and warehouse space in Santa Clara, California which expires in October 2026, and office building space in Gallarate, Italy which expires in August 2027.
The Company also leases vehicles under operating lease arrangements for certain of its personnel in Europe which expire at various times throughout 2025 to 2028.
Supplemental information related to lease expense and valuation of the lease assets and lease liabilities are as follows:
| | | | | | | | | | | | | | | |
| Three Months Ended March 31, | | |
| 2025 | | 2024 | | | | |
Operating lease expense | $ | 311 | | $ | 383 | | | | |
Variable lease expense | 210 | | 135 | | | | |
Total lease expense | $ | 521 | | $ | 518 | | | | |
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Cash paid for amounts included in the measurement of operating lease liabilities | $ | 386 | | $ | 397 | | | | |
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| March 31, 2025 | | December 31, 2024 | | | | |
Weighted average remaining lease term (in years) | 1.54 | | 1.76 | | | | |
Weighted average discount rate | 7.06% | | 7.15% | | | | |
Future minimum lease payments under non-cancelable operating leases as of March 31, 2025 was as follows:
| | | | | |
Year Ending December 31, | (in thousands) |
Remainder of 2025 | $ | 851 | |
2026 | 879 | |
2027 | 20 | |
2028 | 11 | |
2029 | — | |
Thereafter | — | |
Total operating lease payments | 1,761 | |
Less: imputed interest | (88) | |
Total operating lease liabilities | $ | 1,673 | |
| |
As of March 31, 2025, the Company had no operating lease liabilities that had not commenced.
Purchase Commitments and Obligations
The Company has certain purchase commitments related to its inventory management with certain manufacturing suppliers based on the agreements or blanket purchase orders. The contractual obligations represent future cash commitments and liabilities under agreements with third parties and exclude orders for goods and services entered into in the normal course of business that are not enforceable or legally binding. These outstanding commitments amounted to $0.6 million and $0.4 million as of March 31, 2025 and December 31, 2024, respectively.
Indemnification
SI-BONE, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)
The Company enters into standard indemnification arrangements in the ordinary course of business. Pursuant to these arrangements, the Company indemnifies, holds harmless, and agrees to reimburse the indemnified parties for losses suffered or incurred by the indemnified party, in connection with any trade secret, copyright, patent or other intellectual property infringement claim by any third-party with respect to the Company’s technology. The term of these indemnification agreements is generally perpetual. The maximum potential amount of future payments the Company could be required to make under these agreements is not determinable because it involves claims that may be made against the Company in the future, but have not yet been made.
The Company has entered into indemnification agreements with its directors and officers that may require the Company to indemnify its directors and officers against liabilities that may arise by reason of their status or service as directors or officers, other than liabilities arising from willful misconduct of the individual.
The Company has not incurred costs to defend lawsuits or settle claims related to these indemnification agreements. No liability associated with such indemnifications has been recorded to date.
Legal Contingencies
In October 2024, the Company received a civil investigative demand (“CID”) from the U.S. Department of Justice, Civil Division, in connection with an investigation under the federal Anti-Kickback Statute and Civil False Claims Act (the “Investigation”). The CID requests information and documents primarily relating to meals and consulting service payments provided to health care professionals. The Company is cooperating with the Investigation but is currently unable to express a view regarding the likely duration, or ultimate outcome, of the Investigation or estimate the possibility of, or amount or range of, any possible financial impact. Depending on how the Investigation progresses, there may be a material impact on the Company’s business, results of operations, or financial condition.
From time to time, the Company may become involved in legal proceedings arising in the ordinary course of its business. Except with regards to the Investigation, the Company is not presently a party to any material legal proceedings that, if determined adversely to the Company, would have a material adverse effect on the Company.
7. Borrowings
Term Loan
The following table summarizes the outstanding borrowings from the term loan as of periods presented:
| | | | | | | | | | | |
| March 31, 2025 | | December 31, 2024 |
| (in thousands) |
Principal outstanding | $ | 36,000 | | | $ | 36,000 | |
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| | | |
Less: Unamortized debt issuance costs and lender fees | (519) | | | (548) | |
Outstanding debt, net of debt issuance costs and unaccreted value of final payment fee | $ | 35,481 | | | $ | 35,452 | |
Classified as: | | | |
| | | |
Long-term borrowings | $ | 35,481 | | | $ | 35,452 | |
The outstanding debt is related to a Loan and Security Agreement dated August 12, 2021 (the "Original Loan Agreement") entered into by the Company with Silicon Valley Bank, a California corporation (“SVB”). Pursuant to the Original Loan Agreement, SVB provided a term loan in the aggregate principal amount of $35.0 million to the Company (the “Original Term Loan”).
On January 6, 2023, the Company entered into a First Amendment to Loan and Security Agreement with SVB pursuant to which the Company received a new term loan facility in an aggregate principal amount of $36.0 million (the "First Amendment" and with the Original Loan Agreement, collectively the "Amended Loan Agreement”). Upon entry into the Amended Loan Agreement, the Company borrowed $36.0 million pursuant to the term loan (the "First Amendment Term Loan"), which was substantially used to repay in full the $35.0 million Original Term Loan outstanding under the Original Loan Agreement and the Company obtained a secured revolving credit facility in an aggregate principal amount of up to $15.0 million (the “Revolving Line”). The First Amendment also provided for a final payment fee payable to SVB of 2% of the original principal amount of the First Amendment Term Loan due upon the earlier of the First Amendment Term Loan Maturity Date, termination of the Amended Loan Agreement, acceleration by the Lender following an event of default, or prepayment of the First Amendment Term Loan.
SI-BONE, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)
On January 25, 2024, the Company entered into a Second Amendment to Loan and Security Agreement with Silicon Valley Bank, a division of First-Citizens Bank & Trust Company, as successor in interest to SVB ("First Citizens") which amended the Company's Amended Loan Agreement (the “Second Amendment” and together with the Amended Loan Agreement, collectively, the “Second Amended Loan Agreement”). The Second Amendment revised certain provisions related to financial covenants and the periods in which such covenants applied.
On November 8, 2024, the Company entered into a Third Amendment to the Loan and Security Agreement with First-Citizens (the “Third Amendment” and together with the Second Amended Loan Agreement, collectively, the “Third Amended Loan Agreement”), pursuant to which a new term loan in the original aggregate principal amount of $36.0 million was extended by First-Citizens to the Company (the “Third Amendment Term Loan”), which was substantially used to refinance and repay in full the then-outstanding $36.0 million existing First Amendment Term Loan. The Company also paid a final payment fee of $0.7 million due relative to such prior First Amendment Term Loan. The Third Amendment sets the maturity date for the Third Amendment Term Loan as September 1, 2029 (the “Third Amendment Term Loan Maturity Date”), set the first principal repayment due date relative to the Third Amendment Term Loan to October 1, 2027; provided that upon the achievement of the Performance Milestone (as defined in the Third Amendment), the first principal payment shall become due on October 1, 2028. Interest on the Third Amendment Term Loan will be payable monthly at a floating rate per annum equal to the greater of 4.25% and the WSJ Prime Rate minus 0.5%. The Company may elect to prepay the Third Amendment Term Loan in whole prior to the Third Amendment Term Loan Term Loan Maturity Date, subject to a prepayment fee equal to 1.5% of the original principal amount of the Third Amendment Term Loan if the loan is prepaid within 18 months following the closing of the Third Amendment. The Third Amendment further revised certain provisions related to financial covenants and the periods in which such covenants apply.
The Company accounted for the Third Amended Loan Agreement as a debt modification. Accordingly, the remaining unamortized debt issuance costs related to the Second Amended Loan Agreement together with any lender fees incurred in connection with the entry of the Third Amended Loan Agreement are amortized to interest expense using the straight-line method over the new term of the loan through August 2029.
The effective interest rates were 7.3% and 9.3% for the three months ended March 31, 2025 and March 31, 2024, respectively.
The table below summarizes the future principal payments under the Third Amendment Term Loan as of March 31, 2025:
| | | | | |
Year ending December 31, | (in thousands) |
Remainder of 2025 | $ | — | |
2026 | — | |
2027 | 6,000 | |
2028 | 18,000 | |
2029 | 12,000 | |
| |
Total principal payments | $ | 36,000 | |
The Third Amended Loan Agreement includes affirmative and negative covenants applicable to the Company and certain of its foreign subsidiaries. The affirmative covenants include, among others, covenants requiring the Company to maintain its legal existence and governmental compliance, deliver certain financial reports, and maintain insurance coverage. The negative covenants include, among others, restrictions regarding transferring collateral, pledging the Company's intellectual property to other parties, engaging in mergers or acquisitions, paying dividends or making other distributions, incurring indebtedness, transacting with affiliates, and entering into certain investments, in each case subject to certain exceptions. As of March 31, 2025, the Company was in compliance with all debt covenants.
SI-BONE, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)
8. Stock-Based Incentive Compensation Plans
Stock Options
The table below summarizes the stock option activity for the three months ended March 31, 2025:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Number of Shares | | Weighted- Average Exercise Price | | Weighted-Average Contractual Remaining Life (Years) | | Aggregate Intrinsic Value (in thousands) |
Outstanding as of December 31, 2024 | | 1,041,131 | | | $ | 10.98 | | | | | |
| | | | | | | | |
Exercised | | (20,045) | | | $ | 5.11 | | | | | |
Canceled and forfeited | | — | | | $ | — | | | | | |
Outstanding as of March 31, 2025 | | 1,021,086 | | | $ | 11.10 | | | 2.61 | | $ | 5,745 | |
Options vested and exercisable, March 31, 2025 | | 1,021,086 | | | $ | 11.10 | | | 2.61 | | $ | 5,745 | |
Options vested and expected to vest, March 31, 2025 | | 1,021,086 | | | $ | 11.10 | | | 2.61 | | $ | 5,745 | |
As of March 31, 2025, there is no unrecognized compensation cost related to stock options.
There were no stock options granted during the three months ended March 31, 2025 and 2024.
Restricted Stock Units (“RSUs”)
RSUs are share awards that entitle the holder to receive freely tradable shares of the Company’s common stock upon vesting. RSUs generally vest over one to four years based upon continued services and are settled at vesting in shares of the Company's common stock. Certain RSUs vest based upon continued services and the achievement of financial milestones. The grant date fair value of the RSUs is equal to the closing price of the Company’s common stock on the grant date.
The Company granted performance-based restricted stock unit awards subject to market and service vesting conditions to certain executive officers under SI-BONE's 2018 Equity Incentive Plan (“PSUs”). The shares subject to PSUs vest over a three-year performance period. The actual number of PSUs that will vest in each measurement period will be determined by the Compensation Committee based on the Company’s total shareholder return (“TSR”) relative to the TSR of the Median Peer Companies (as defined in the award agreement). The grant date fair value of each stock award with a market condition was determined using the Monte Carlo valuation model. The table below summarizes the assumptions used to estimate the grant date fair value of the PSUs granted:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | Three Months Ended March 31, |
| | | | | | | | | | | | | 2025 | | 2024 | | |
Expected volatility of common stock | | | | | | | | | | | 49.0% | to | 57.0% | | 47.0% | to | 59.0% | | | | |
Expected volatility of peer companies | | | | | | | | | | | | | 30.0% | to | 126.0% | | 29.0% | to | 97.0% | | | | |
Correlation coefficient of peer companies | | | | | | | | | | | 0.05 | to | 1.00 | | (0.01) | to | 1.00 | | | | |
Risk-free interest rate | | | | | | | | | | | | | 4.1% | to | 4.2% | | 4.1% | to | 4.7% | | | | |
Dividend yield | | | | | | | —% | to | 1.0% | | 0.6% | to | 4.7% | | | | |
SI-BONE, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)
The table below summarizes RSU and PSU activity for the three months ended March 31, 2025:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | RSUs | | PSUs |
| | Number of Shares | | Weighted Average Grant Date Fair Value | | Number of Shares | | Weighted Average Grant Date Fair Value |
Outstanding as of December 31, 2024 | | 1,884,640 | | $18.47 | | 610,541 | | $16.47 |
Granted | | 1,128,922 | | 16.79 | | 337,110 | | 15.89 |
Vested | | (252,923) | | 20.20 | | (120,155) | | 15.75 |
Canceled and forfeited | | (51,377) | | 18.76 | | (42,039) | | 19.50 |
Outstanding as of March 31, 2025 | | 2,709,262 | | 17.61 | | 785,457 | | 16.17 |
Employee Stock Purchase Plan
The Company’s 2018 Employee Stock Purchase Plan (the “ESPP”) allows eligible employees to purchase shares of the Company's common stock through payroll deductions at the price equal to 85% of the lesser of the fair market value of the stock as of the first date or the ending date of each six month offering period. The offering period generally commences in May and November. On March 26, 2020, the Company's Compensation Committee approved the amendment of the terms of future offerings under the ESPP which, among other things, increased the maximum number of shares that may be purchased on any single purchase date, provided for automatic enrollment in a new offering.
The fair value of the ESPP shares is estimated using the Black-Scholes option pricing model, which is being amortized over the requisite service period. The Company did not issue any shares under ESPP for the three months ended March 31, 2025 and 2024. As of March 31, 2025 and December 31, 2024, total accumulated ESPP related employee payroll deductions amounted to $1.3 million and $0.3 million, respectively, which were included within accrued compensation and related expenses in the condensed consolidated balance sheets.
SI-BONE, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)
Stock-Based Compensation
The table below presents the detail of stock-based compensation expense amounts included in the condensed consolidated statements of operations:
| | | | | | | | | | | | | | | | | | |
| | Three Months Ended March 31, | | |
| | 2025 | | 2024 | | | | |
| | (in thousands) |
Cost of goods sold | | $ | 160 | | | $ | 235 | | | | | |
Sales and marketing | | 2,623 | | | 3,221 | | | | | |
Research and development | | 834 | | | 820 | | | | | |
General and administrative | | 3,046 | | | 2,754 | | | | | |
| | $ | 6,663 | | | $ | 7,030 | | | | | |
Warrants
The table below summarizes common stock warrants activity for the three months ended March 31, 2025:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Date | | Outstanding Balance at December 31, 2024 | | Price per Share | | Warrants Issued | | Warrant Exercised | | Warrant Expired | | Outstanding Balance at March 31, 2025 |
Issuance | | Expiration | | | | | |
3/1/2017 | | 3/1/2027 | | 1,388 | | | $ | 5.94 | | | — | | — | | — | | 1,388 | |
10/20/2015 | | 10/20/2025 | | 41,650 | | | $ | 16.47 | | | — | | — | | — | | 41,650 | |
11/9/2015 | | 11/9/2025 | | 25,709 | | | $ | 16.47 | | | — | | — | | — | | 25,709 | |
12/22/2016 | | 12/22/2026 | | 9,712 | | | $ | 10.03 | | | — | | — | | — | | 9,712 | |
| | | | 78,459 | | | | | — | | — | | — | | 78,459 | |
9. Net Loss Per Share of Common Stock
The table below summarizes the computation of basic and diluted net loss per share:
| | | | | | | | | | | | | | | |
| Three Months Ended March 31, | | |
| 2025 | | 2024 | | | | |
| (in thousands, except share and per share data) |
Net loss | $ | (6,542) | | | $ | (10,904) | | | | | |
| | | | | | | |
Weighted-average shares used to compute basic and diluted net loss per share | 42,337,481 | | | 40,934,392 | | | | | |
| | | | | | | |
Net loss per share, basic and diluted | $ | (0.15) | | | $ | (0.27) | | | | | |
Because the Company has reported a net loss in all periods presented, outstanding stock options, restricted stock units, ESPP purchase rights and common stock warrants are anti-dilutive and therefore diluted net loss per common share is the same as basic net loss per common share for the periods presented. The following anti-dilutive common stock equivalents were excluded from the computation of diluted net loss per share for the periods presented:
SI-BONE, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)
| | | | | | | | | | | | | | | |
| Three Months Ended March 31, | | |
| 2025 | | 2024 | | | | |
Stock options | 1,021,086 | | 1,158,816 | | | | |
Restricted stock units | 3,494,719 | | 2,847,021 | | | | |
| | | | | | | |
ESPP purchase rights | 145,509 | | 102,172 | | | | |
Common stock warrants | 78,459 | | 85,139 | | | | |
| 4,739,773 | | | 4,193,148 | | | | | |
| | | | | | | |
10. Income Taxes
In determining quarterly provisions for income taxes, the Company uses the annual estimated effective tax rate applied to the actual year-to-date profit or loss, adjusted for discrete items arising in that quarter. The Company updates its estimate of its annual effective tax rate at the end of each quarterly period. The estimate takes into account annual forecasted income (loss) before income taxes, the geographic mix of income (loss) before income taxes and any significant permanent tax items. The Company did not have provision for income taxes for the three months ended March 31, 2025 and 2024. The Company continues to maintain a full valuation allowance against its net deferred tax assets due to the uncertainty surrounding realization of such assets.
The Company accounts for the uncertainty in income taxes by utilizing a comprehensive model for the recognition, measurement, presentation and disclosure in financial statements of any uncertain tax positions that have been taken or are expected to be taken on an income tax return. There had been no changes in the estimated uncertain tax benefits recorded as of March 31, 2025 compared to December 31, 2024.
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and the related notes to those statements included elsewhere in this Quarterly Report on Form 10-Q, and with the consolidated financial statements and management’s discussion and analysis of our financial condition and results of operations in our Annual Report on Form 10-K filed with the SEC on February 25, 2025. Some of the information contained in this discussion and analysis, or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many important factors, including those set forth in the “Risk Factors” section of our Annual Report on Form 10-K filed on February 25, 2025, our actual results could differ materially from the results described in, or implied, by these forward-looking statements.
Overview
We are a medical device company dedicated to solving musculoskeletal disorders of the sacropelvic anatomy. Leveraging our knowledge of pelvic anatomy and biomechanics, we have pioneered proprietary minimally invasive surgical implant systems to address sacroiliac joint dysfunction as well as address unmet clinical needs in pelvic fixation and management of pelvic fractures.
Our products include a series of patented titanium implants and the instruments used to implant them, as well as implantable bone products. Since launching our first generation iFuse in 2009, we have launched multiple implant product lines, including iFuse-3D in 2017, iFuse TORQ in 2021, iFuse Bedrock Granite in 2022, and iFuse INTRA and iFuse TORQ TNT in 2024. In the United States, iFuse, iFuse-3D, iFuse TORQ and iFuse Bedrock Granite have clearances for applications in sacroiliac joint dysfunction, adult spinal deformity and pelvic trauma. iFuse TORQ TNT has clearances for applications in pelvic trauma and sacroiliac joint dysfunction.
We market our products primarily with a direct sales force as well as a number of third-party sales agents in the United States, and with a combination of a direct sales force, and sales agents and resellers in other countries. As of March 31, 2025, over 120,000 procedures have been performed using our products by over 4,500 physicians in the United States and 38 other countries since we introduced iFuse in 2009.
Factors Affecting Results of Operations and Key Performance Indicators
We monitor certain key performance indicators that we believe provide us and our investors indications of conditions that may affect results of our operations. Our revenue growth rate and commercial progress is impacted by, among other things, our key performance indicators, including our ability to expand access to solutions, increase physician penetration, launch new products, address human capital needs and gain operational efficiencies.
Expand Access to Solutions
As we expand our portfolio, the experience, caliber, and strong clinician relationships of our sales force, including our network of third-party sales agents, will be crucial to drive adoption of our future products and procedures. Since our initial public offering in 2018, we have made significant investments in our commercial infrastructure to build a valuable sales team to expand the market, drive physician engagement and deliver revenue growth.
While we will continue to selectively expand our sales force, we are also focused on increasing our sales managers' capacity and driving sales force productivity by adding more clinical support specialists and implementing hybrid models, including selectively adding third-party sales agents for case coverage, and by placing instrument trays and implants at select sites of service. This expansion of our sales force is one aspect of increasing the overall number of procedures in a given period that we can support with products, which is what we call “surgical capacity.” Our surgical capacity is also limited by the volume of implant inventory and the number of instrument trays held ready for surgery, either at our headquarters facility, forward deployed with our sales force or placed at customer facilities. As we grow, and as adoption of our solutions continues to mature, our overall surgical capacity may become an important driver of the amount of revenue that we can generate.
As of March 31, 2025, our U.S. sales force consisted of 85 territory sales managers and 78 clinical support specialists directly employed by us and 278 third-party sales agents, compared to 85 territory sales managers and 67 clinical support specialists directly employed by us and 183 third-party sales agents as of March 31, 2024. As of March 31, 2025, our international sales force consisted of 10 sales representatives directly employed by us and a total of 29 third-party sales agents and resellers, compared to 12 sales representatives directly employed by us and a total of 28 third-party sales agents and resellers as of March 31, 2024.
For the quarter ended March 31, 2025, over 30 percent of our procedures for sacroiliac joint dysfunction were performed at ambulatory surgery centers (ASCs) or Office-Based Labs (OBLs). With the steady increase in the numbers of minimally invasive procedures, including sacroiliac joint fusion procedures, being performed at ASCs or OBLs, we continue to actively engage with these facilities to educate their management groups on our clinical evidence, exclusive commercial payor coverage and focus on driving improved education and pathways between pain physicians and surgeons.
Physician Engagement
Engaging and educating physician and other healthcare professionals about the clinical merits and patient benefits of our solutions will be important to grow physician adoption. Our medical affairs team works closely with our sales team to increase physician engagement and activation. Physician activity includes both the number of physicians performing our procedures as well as the number of procedures performed per physician. In addition to training new physicians, we have several initiatives to re-engage inactive physicians.
We use a combination of hands-on cadaveric and dry-lab training, as well as the SI-BONE SImulator - a portable, radiation-free, haptics and computer-based simulator - for training purposes, and optimize our programs to improve adoption rate, time to first case and ultimately physician productivity.
We are currently targeting over 12,000 U.S. physicians, including over 8,000 orthopedic and neurological surgeons and approximately 4,500 interventional spine physicians, to perform our procedures. As of March 31, 2025 and 2024, in the United States more than 3,400 and 2,700 physicians, respectively, have been trained on our products and have treated at least one patient. Outside the United States, as of March 31, 2025 and 2024, more than 1,100 and 1,000 physicians, respectively, have been trained on our product and have treated at least one patient. Since launching our academic training program in August 2018, we have trained residents and fellows in over 275 academic programs in the United States, resulting in the training of approximately 1,900 surgical residents and fellows.
Expand Addressable Markets
Expanding our platform of sacropelvic solutions to address sacroiliac joint dysfunction, pelvic fixation and pelvic trauma has been a key tenet of our strategy, and we have made substantial progress on this mission. With iFuse-3D, iFuse TORQ, iFuse Bedrock Granite and iFuse TORQ TNT, we believe that the value of our innovative, versatile, and complementary product portfolio provides physicians with a comprehensive set of alternatives, and positions us as the top choice for physicians for sacropelvic solutions. We also offer an allograft bone implant for physicians who believe that this kind of implant can be important in addressing sacroiliac joint dysfunction.
In June 2022, we completed enrollment in SILVIA, a two-year prospective international multi-center randomized controlled trial of two different methods for pelvic fixation in adult patients undergoing multi-segmental, or long-construct, spinal fusion. We anticipate the results for the primary endpoint in second half of 2025. In September 2022, we began enrolling patients in our SAFFRON study, a prospective randomized controlled trial of surgery using our iFuse TORQ device vs. non-surgical management in patients with debilitating sacral fragility or insufficiency fractures. We are no longer actively recruiting patients in SAFFRON and anticipate publishing follow-up results in second half of 2025. We are working with a select group of physicians on STACI, a prospective study on the use of iFuse TORQ in patients with sacroiliac joint dysfunction. The purpose of STACI is to provide post-market information on the safety and effectiveness of minimally invasive sacroiliac joint fusion procedures performed with iFuse TORQ.
We continue to invest in research and development initiatives to bring new and differentiated solutions to the market that deliver on our vision of improving patient quality of life through differentiated solutions to target segments with a clear unmet clinical need. Robust clinical evidence is central to drive adoption and favorable reimbursement, and we remain focused on continuing to set the industry standard in delivering evidence-based care through best-in-class clinical trials that demonstrate the efficacy, safety, and economic benefit of our solutions. During the three months ended March 31, 2025, we spent $4.5 million on research and development, equating to 10% of our revenue. During the three months ended March 31, 2024, we spent $4.3 million on research and development, equating to 11% of our revenue.
Enhance Employee Experience and Engagement
Our ability to recruit, develop and retain highly skilled talent is a significant determinant of our success. To attract, develop and retain our talent, we seek to create a diverse and inclusive workplace with opportunities for our employees to thrive and advance in their careers. We support this with market-competitive compensation, comprehensive benefits, and health and wellness programs.
In addition to fostering an inclusive workplace and ensuring equitable compensation for our employees, we maintain a strong focus on enhancing employee retention and job satisfaction. To achieve this, we have established a feedback mechanism to continually monitor and respond to employee sentiment. Using this feedback, we deploy strategies that enhance the skills of our people managers and improve internal communications with employees. Furthermore, we provide ongoing learning and leadership training opportunities to support professional growth.
In 2024, we conducted instructor-led trainings designed to build people leadership capabilities and train managers on delivering actionable feedback. We have also adopted a goal for each of our managers to have regular check-ins with employees to discuss their personal goals and career plans in furtherance of our commitment to career and professional development.
Gain operational efficiency
To support our growing portfolio of solutions, we continue to evolve our business processes to identify, measure and improve operational efficiency. The information developed will allow us to optimize processes, increase sales force productivity and improve asset utilization.
We are focused on increasing our territory sales managers’ and sales representatives’ capacity, efficiency and productivity. We may do this by adding more clinical support specialists and third-party sales agents as part of hybrid arrangements for case coverage, and by consigning instrument trays and implants at select sites of service. As of March 31, 2025, our trailing twelve month average revenue per territory sales manager has increased to approximately $2.0 million from $1.6 million as of March 31, 2024.
We have made significant investments in instrument trays used to perform surgeries. Our goal is to deploy instrument trays to the market where the demand exists to increase our asset utilization rates over time and use capital more effectively by having our instrument trays used in more surgeries in any given time period. Given supply chain disruptions impacting the industry, we are working closely with our suppliers to reduce lead time for our implants to ensure we can support our expanding physician footprint and over time build the resilience in our supply chain to reduce our cash investment in inventory. Additionally, we are partnering with our suppliers around design for manufacturing, specifically for newer products, to reduce the overall cost of the implants as we scale, and reduce waste and rework. Lastly, we are integrating our demand planning and manufacturing systems, to ensure we leverage actual usage trends as we build surgical capacity to support our growth.
Components of Results of Operations
Revenue
Our revenue from sales of implants fluctuates based on volume of cases (procedures performed), discounts, mix of international and U.S. sales, different implant pricing and the number of implants used for a particular patient. Similar to other orthopedic companies, our case volume can vary from quarter to quarter due to a variety of factors including reimbursement, sales force changes, physician activities, product launches, and seasonality. In addition, our revenue is impacted by changes in average selling price as we respond to the competitive landscape and price differences at different medical facilities, such as hospitals, ASCs and OBLs. Further, revenue results can differ based upon the mix of business between U.S. and international sales mix of our products used, and the sales channel through which each procedure is supported. Our revenue from international sales is impacted by fluctuations in foreign currency exchange rates between the U.S. dollar (our reporting currency) and the local currency.
Our business is affected by seasonal variations. For instance, we have historically experienced lower sales in the summer months and higher sales in the last quarter of the fiscal year as patients have more time in the winter months to have the procedure completed or want to take advantage of their annual limits on deductibles, co-payments and other out-of-pocket payments specified in their insurance plans. However, taken as a whole, seasonality does not have a material impact on our financial results from year to year.
Cost of Goods Sold, Gross Profit, and Gross Margin
We utilize third-party manufacturers for production of our implants and instrument trays. Cost of goods sold consists primarily of costs of the components of implants and instruments, instrument tray depreciation, royalties, scrap and inventory obsolescence, as well as distribution-related expenses such as logistics and shipping costs. Our cost of goods sold has historically increased as case levels increase and from changes in our product mix.
Operating Expenses
Our operating expenses consist of sales and marketing, research and development, and general and administrative expenses. Personnel costs are the most significant component of operating expenses and consist of salaries, sales commissions and other cash and stock-based compensation related expenses. We intend to make investments to execute our strategic plans and operational initiatives. We anticipate certain operating expenses will continue to increase to support our growth.
Sales and Marketing Expenses
Sales and marketing expenses primarily consist of salaries, stock-based compensation expense, and other compensation related costs, for personnel employed in sales, marketing, medical affairs, reimbursement and professional education departments. In addition, our sales and marketing expenses include commissions and bonuses, generally based on a percentage of sales, as well as certain commission guarantees paid to our senior sales management, territory sales managers, clinical support specialists and third-party sales agents.
Research and Development Expenses
Our research and development expenses primarily consist of engineering, product development, clinical and regulatory expenses (including clinical study expenses), consulting services, outside prototyping services, outside research activities, materials, depreciation, and other costs associated with development of our products. Research and development expenses also include related personnel compensation and stock-based compensation expense. We expense research and development costs as they are incurred.
Research and development expenses for engineering projects fluctuate with project timing. Based upon our broader set of product development initiatives and the stage of the underlying projects, we expect to continue to make investments in research and development. As such, we anticipate that research and development expenses will continue to increase in the future.
General and Administrative Expenses
General and administrative expenses primarily consist of salaries, stock-based compensation expense, and other costs for finance, accounting, legal, insurance, compliance, and administrative matters.
Interest Income
Interest income is primarily related to our investments of excess cash in money market funds and marketable securities.
Interest Expense
Interest expense is primarily related to borrowings, amortization of debt issuance costs, and accretion of final fees on the First-Citizens Third Amended Loan Agreement.
Other Income (Expense), Net
Other income (expense), net consists primarily of net foreign exchange gains and losses on foreign transactions.
Results of Operations
We manage and operate as one reportable segment. The table below summarizes our results of operations for the periods presented (percentages are amounts as a percentage of revenue), which we derived from the accompanying condensed consolidated financial statements:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended March 31, | | |
| 2025 | | 2024 | | | | |
| Amount | | % | | Amount | | % | | | | | | | | |
| (in thousands, except for percentages) |
Consolidated Statements of Operations Data: | | | | | | | | | | | | |
Revenue | $ | 47,290 | | | 100 | % | | $ | 37,867 | | | 100 | % | | | | | | | | |
Cost of goods sold | 9,595 | | | 20 | % | | 8,002 | | | 21 | % | | | | | | | | |
Gross profit | 37,695 | | | 80 | % | | 29,865 | | | 79 | % | | | | | | | | |
Operating expenses: | | | | | | | | | | | | | | | |
Sales and marketing | 30,681 | | | 65 | % | | 29,387 | | | 78 | % | | | | | | | | |
Research and development | 4,534 | | | 10 | % | | 4,345 | | | 11 | % | | | | | | | | |
General and administrative | 9,960 | | | 21 | % | | 8,176 | | | 22 | % | | | | | | | | |
Total operating expenses | 45,175 | | | 96 | % | | 41,908 | | | 111 | % | | | | | | | | |
Loss from operations | (7,480) | | | (16) | % | | (12,043) | | | (32) | % | | | | | | | | |
Interest and other income (expense), net: | | | | | | | | | | | | | | |
Interest income | 1,592 | | | 3 | % | | 2,113 | | | 6 | % | | | | | | | | |
Interest expense | (662) | | | (1) | % | | (881) | | | (2) | % | | | | | | | | |
Other income (expense), net | 8 | | | — | % | | (93) | | | — | % | | | | | | | | |
Net loss | $ | (6,542) | | | (14) | % | | $ | (10,904) | | | (28) | % | | | | | | | | |
We derive the majority of our revenue from sales to customers in the U.S. Revenue by geography is based on billing address of the customer. The table below summarizes our revenue by geography:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended March 31, | | |
| 2025 | | 2024 | | | | |
| Amount | | % | | Amount | | % | | | | | | | | |
| (in thousands except for percentages) |
United States | $ | 44,836 | | | 95 | % | | $ | 35,425 | | | 94 | % | | | | | | | | |
International | 2,454 | | | 5 | % | | 2,442 | | | 6 | % | | | | | | | | |
| $ | 47,290 | | | 100 | % | | $ | 37,867 | | | 100 | % | | | | | | | | |
Comparison of the Three Months Ended March 31, 2025 and 2024
Revenue, Cost of Goods Sold, Gross Profit, and Gross Margin:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended March 31, | | | | |
| 2025 | | 2024 | | $ Change | | % Change |
| (in thousands, except for percentages) |
Revenue | $ | 47,290 | | | $ | 37,867 | | | $ | 9,423 | | | 25% |
Cost of goods sold | 9,595 | | | 8,002 | | | 1,593 | | | 20% |
Gross profit | $ | 37,695 | | | $ | 29,865 | | | $ | 7,830 | | | 26% |
Gross margin | 80 | % | | 79 | % | | | | |
Revenue. The increase in revenue for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024 was primarily driven by a $9.4 million increase in our U.S. revenue from increased case volumes due to our expanded product portfolio.
Gross Profit and Gross Margin. Gross profit increased $7.8 million for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024, mainly driven by higher revenue. The gross margin was 80% for the three months ended March 31, 2025 compared to a gross margin of 79% for the three months ended March 31, 2024 due to lower product costs, partially offset by higher royalties and reserves.
Operating Expenses: | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended March 31, | | | | |
| 2025 | | 2024 | | $ Change | | % Change |
| (in thousands, except for percentages) |
Sales and marketing | $ | 30,681 | | | $ | 29,387 | | | $ | 1,294 | | | 4 | % |
Research and development | 4,534 | | | 4,345 | | | 189 | | | 4 | % |
General and administrative | 9,960 | | | 8,176 | | | 1,784 | | | 22 | % |
Total operating expenses | $ | 45,175 | | | $ | 41,908 | | | $ | 3,267 | | | 8 | % |
Sales and Marketing Expenses. The increase in sales and marketing expenses for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024 was primarily due to a $2.5 million increase in commissions and personnel cost driven by higher revenues, partially offset by a decrease of $1.2 million related to travel, stock-based compensation and consulting.
Research and Development Expenses. The slight increase in research and development expenses for the three months ended March 31, 2025 compared to the three months ended March 31, 2024 was primarily due an increase in employee-related costs and stock-based compensation due to an increase in headcount within research and development departments.
General and Administrative Expenses. The increase in general and administrative expenses for the three months ended March 31, 2025 compared to the three months ended March 31, 2024 was primarily due to a $0.7 million increase in employee-related costs and stock-based compensation due to an increase in headcount within general and administrative departments and a $1.0 million increase in legal and consulting fees.
Interest and Other Income (Expense), Net: | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended March 31, | | | | |
| 2025 | | 2024 | | $ Change | | % Change |
| (in thousands, except for percentages) |
Interest income | $ | 1,592 | | | $ | 2,113 | | | $ | (521) | | | (25) | % |
Interest expense | (662) | | | (881) | | | 219 | | | 25 | % |
Other income (expense), net | 8 | | | (93) | | | 101 | | | 109 | % |
Total interest and other expense, net | $ | 938 | | | $ | 1,139 | | | $ | (201) | | | (18) | % |
Interest Income. The decrease in interest income for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024 was primarily due to lower investment balances.
Interest Expense. The decrease in interest expense for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024 was due to lower interest rates associated with the First-Citizens Third Amendment Term Loan.
Other Income (Expense), Net. The change in other income (expense), net for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024 was primarily due to foreign currency fluctuations.
Liquidity and Capital Resources
As of March 31, 2025, we had cash and marketable securities of $144.4 million as compared to $150.0 million as of December 31, 2024. We have financed our operations primarily through the sale of our common stock in our public offerings and debt financing arrangements. As of both March 31, 2025 and December 31, 2024, we had $35.5 million in outstanding debt.
As of March 31, 2025, we had an accumulated deficit of $437.9 million as compared to $431.4 million as of December 31, 2024. During the three months ended March 31, 2025, we incurred a net loss of $6.5 million. During the years ended December 31, 2024 and 2023, we incurred a net loss of $30.9 million and $43.3 million, respectively, and expect to incur additional losses in the future. We have not achieved positive cash flow from operations to date.
Based upon our current operating plan, we believe that our existing cash and marketable securities will enable us to fund our operating expenses and capital expenditure requirements over the next 12 months from the filing of this Form 10-Q. However, the financial impact of a potential economic downturn or capital market disruptions pose risks to and uncertainties in our future available capital resources. We may face challenges and uncertainties and, as a result, may need to raise additional capital as our available capital resources may be consumed more rapidly than currently expected due to, but not limited to (a) decreases in sales of our products and the uncertainty of future revenues from new products; (b) changes we may make to the business that affect ongoing operating expenses; (c) changes we may make in our business strategy; (d) regulatory and reimbursement developments affecting our existing products; (e) changes we may make in our research and development spending plans; and (f) other items affecting our forecasted level of expenditures and use of cash resources. In addition, as we seek to deploy new product offerings, the need for additional capital to fund the purchase of inventories of implants and instrument trays may become more acute and may limit the number of revenue opportunities that we pursue. Each new product family introduced typically requires the purchase of consumable implant inventory as well as investment in a fleet of instrument trays required to support procedures nationwide.
Term Loan
Our outstanding debt is related to a Loan and Security Agreement (the “Original Loan Agreement”) dated August 12, 2021 (the “Effective Date”), entered into by us and Silicon Valley Bank, a California corporation (“SVB”). Pursuant to the Original Loan Agreement, SVB provided us with a term loan in the aggregate principal amount of $35.0 million (the “Original Term Loan”).
On January 6, 2023, we entered into a First Amendment to Loan and Security Agreement with SVB (the “First Amendment”, and together with the Original Loan Agreement, collectively the “Amended Loan Agreement”). Upon entry into the Amended Loan Agreement, we borrowed $36.0 million pursuant to a new term loan (the “First Amendment Term Loan”), which was substantially used to repay in full the $35.0 million Original Term Loan outstanding under the Original Loan Agreement, and we also obtained a secured a revolving credit facility in an aggregate principal amount of up to $15.0 million (the “Revolving Line").
On January 25, 2024, we entered into a Second Amendment to Loan and Security Agreement with Silicon Valley Bank, a division of First-Citizens Bank & Trust Company, as successor in interest to SVB (“First-Citizens”) which further amended our Amended Loan Agreement (the “Second Amendment” and together with the Amended Loan Agreement, collectively, the “Second Amended Loan Agreement”). The Second Amendment revised certain provisions related to financial covenants and the periods in which such covenants applied.
On November 8, 2024, we entered into a Third Amendment to Loan and Security Agreement with First-Citizens (the “Third Amendment” and together with the Second Amended Loan Agreement, collectively, the “Third Amended Loan Agreement”), relative to a new term loan in the original aggregate principal amount of $36.0 million extended by First-Citizens to the Company (the “Third Amendment Term Loan”), which was substantially used to refinance and repay in full the then-outstanding $36.0 million existing First Amendment Term Loan. We also paid a certain final payment fee due relative to such prior First Amendment Term Loan. The Third Amendment set the maturity date for the Third Amendment Term Loan to September 1, 2029 (the "Third Amendment Term Loan Maturity Date"), and set the first principal repayment due date relative to the Third Amendment Term Loan to October 1, 2027; provided that upon the achievement of the Performance Milestone (as defined in the Third Amendment), the first principal payment shall become due on October 1, 2028. Interest on the outstanding principal balance of the Third Amendment Term Loan is payable monthly at a floating rate per annum equal to the greater of 4.25% and the WSJ prime rate minus 0.5%. The Company may elect to prepay the Third Amendment Term Loan in whole prior to the Third Amendment Term Loan Maturity Date, subject to a prepayment fee equal to 1.5% of the original principal amount of the Third Amendment Term Loan if the loan is prepaid within 18 months following the closing of the Third Amendment. The Third Amendment further revised certain provisions related to financial covenants and the periods in which such covenants apply, and First-Citizens and the Company also agreed to terminate the Revolving Line and an uncommitted accordion term loan provision.
Our material cash requirements include various contractual and other obligations consisting of long-term debt obligations with First-Citizens, operating lease obligations and purchase obligations with some of our suppliers and have not changed materially since the Form 10-K filed with the SEC on February 25, 2025. As of March 31, 2025, expected timing of those payments are as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | Payments Due By Period |
| Total | | Less than 1 year | | 1-3 years | | 4-5 years | | More than 5 years |
| (in thousands) |
Principal obligations (1) | $ | 36,000 | | | $ | — | | | $ | 6,000 | | | $ | 30,000 | | | $ | — | |
Interest obligations (2) | 8,844 | | | 1,925 | | | 5,056 | | | 1,863 | | | — | |
Operating lease obligations | 1,761 | | | 851 | | | 899 | | | 11 | | | — | |
Purchase obligations | 554 | | | 554 | | | — | | | — | | | — | |
Total | $ | 47,159 | | | $ | 3,330 | | | $ | 11,955 | | | $ | 31,874 | | | $ | — | |
(1)Represents the principal obligations of our First-Citizens Third Amendment Term Loan.
(2)Represents the future interest obligations on our First-Citizens Third Amendment Term Loan estimated using an interest rate of 7% as of March 31, 2025.
This compares to $48.1 million of contractual obligations as of December 31, 2024.
Cash Flows
The following table sets forth the primary sources and uses of cash for each of the periods presented below: | | | | | | | | | | | | | | | | | | | |
| Three Months Ended March 31, | | | | |
| 2025 | | 2024 | | $ Change | | |
Net cash provided by (used in): | (in thousands) |
Operating activities | $ | (4,911) | | | $ | (7,571) | | | $ | 2,660 | | | |
Investing activities | 10,630 | | | 6,347 | | | 4,283 | | | |
Financing activities | 103 | | | 105 | | | (2) | | | |
Effects of exchange rate changes on cash and cash equivalents | 417 | | | (112) | | | 529 | | | |
Net increase (decrease) in cash and cash equivalents | $ | 6,239 | | | $ | (1,231) | | | $ | 7,470 | | | |
Cash Used in Operating Activities
Net cash used in operating activities for the three months ended March 31, 2025 of $4.9 million resulted from cash outflows due to a net loss of $6.5 million, adjusted for $7.8 million of non-cash items, and cash outflows from net changes in operating assets and liabilities of $6.2 million. Net cash used in operating activities for the three months ended March 31, 2024 of $7.6 million resulted from cash outflows due to a net loss of $10.9 million, adjusted for $7.1 million of non-cash items, and cash outflows from changes in operating assets and liabilities of $3.7 million. The decrease in net loss, net of non-cash items for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024 was mainly due to increased revenues. Net cash outflows from changes in operating assets and liabilities for the three months ended March 31, 2025 was primarily due to higher inventory build-up related to our new product introductions and higher account payable and lower accrued liabilities attributable to the normal timing of expenses. Net cash outflows from changes in operating assets and liabilities for the three months ended March 31, 2024 was primarily due to higher account payables and lower accrued liabilities attributable to the normal course timing of expenses.
Cash Flows From Investing Activities
Net cash provided by investing activities in the three months ended March 31, 2025 was $10.6 million as compared to cash used in investing activities of $6.3 million in the three months ended March 31, 2024. Net cash provided by investing activities for the three months ended March 31, 2025 consisted of maturities of our marketable securities net of purchases of $12.7 million, and purchases of property and equipment of $2.1 million primarily related to individual components in instrument sets to support revenue growth. Net cash used in investing activities for the three months ended March 31, 2024 consisted of purchases of our marketable securities net of maturities of $8.4 million, and purchases of property and equipment of $2.1 million primarily related to individual components in instrument sets.
Cash Provided by Financing Activities
Cash provided by financing activities in the three months ended March 31, 2025 and 2024 was $0.1 million resulting from the issuance of common stock under our stock-based incentive compensation plans.
Critical Accounting Policies, Significant Judgments, and Use of Estimates
This discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, as well as the reported revenue generated, and expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates.
Our critical accounting policies and estimates are described in “Management's Discussion and Analysis of Financial Condition and Results of Operations - Critical Accounting Policies, Significant Judgments, and Use of Estimates” in our 2024 Annual Report. There had been no material changes to the descriptions of these accounting policies, judgments and estimates.
Seasonality
Our business is affected by seasonal variations. For instance, we have historically experienced lower sales in the summer months and higher sales in the last quarter of the fiscal year. However, taken as a whole, seasonality does not have a material impact on our financial results.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
We are exposed to market risks, including changes to foreign currency exchange rates and interest rates.
Foreign Currency Exchange Risk
We have foreign currency risks related to our revenue and operating expenses denominated in currencies other than the U.S. dollar, primarily the Euro. Accordingly, changes in exchange rates, and in particular a strengthening of the U.S. dollar, have in the past, and may in the future, negatively affect our revenue and other operating results as expressed in U.S. dollars.
We have experienced and will continue to experience fluctuations in net loss as a result of transaction gains or losses related to remeasuring certain current asset and current liability balances denominated in currencies other than the functional currency of the entities in which they are recorded. At this time, we have not entered into, but in the future we may enter into, derivatives or other financial instruments in an attempt to hedge our foreign currency exchange risk. It is difficult to predict the effect hedging activities would have on our results of operations. Foreign currency gains or losses, net recognized in the three months ended March 31, 2025 and 2024 were not material. A hypothetical 100 basis point change in foreign exchange rates during any of the periods presented would not have had a material impact on our condensed consolidated financial statements.
Interest Rate Risk
Our exposure to changes in interest rates relates to interest earned and market value on our cash and cash equivalents and short-term investments. Our cash and cash equivalents and short-term investments consist of cash, money market funds, U.S. government securities. The market value of our marketable securities may decline if current market interest rates rise. Our investment policy and strategy are focused on preservation of capital and supporting our liquidity requirements. We do not make investments for trading or speculative purposes.
With the execution of the Third Amendment with First-Citizens relative to the Third Amendment Term Loan, interest is payable monthly at a floating annual rate set at the greater of the prime rate as published in the Wall Street Journal minus 0.5% or 4.25%. Rising interest rates will increase the amount of interest paid on this debt. We believe that our exposure to interest rate risk is not significant due to the low risk profile of our investments and the amount of our Third Amendment Term Loan, therefore a hypothetical 100 basis point in market interest rates during any of the periods presented would not have had a material impact on our condensed consolidated financial statements.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Securities and Exchange Act of 1934 is (i) recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and (ii) accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.
Internal control over financial reporting has inherent limitations. Internal control over financial reporting is a process that involves human diligence and compliance and is subject to lapses in judgment and breakdowns resulting from human failures. Internal control over financial reporting also can be circumvented by collusion or improper management override. Because of such limitations, there is a risk that material misstatements will not be prevented or detected on a timely basis by internal control over financial reporting. However, these inherent limitations are known features of the financial reporting process. Therefore, it is possible to design into the process safeguards to reduce, though not eliminate, this risk.
As of March 31, 2025, our management, with the participation of our Chief Executive Officer (“CEO”) and our Chief Financial Officer (“CFO”), have evaluated our disclosure controls and procedures (as defined in Rules 13a‑15(e) and 15d‑15(e) under the Securities Exchange Act of 1934). Based on that evaluation, our CEO and our CFO have concluded that, as of March 31, 2025, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in internal control over financial reporting
During the quarter ended March 31, 2025, there were no changes in our internal controls over financial reporting that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II—OTHER INFORMATION
Item 1. Legal Proceedings
We are involved in various claims, complaints, investigations and legal actions that arise from time to time in the normal course of business, including commercial and employment matters. There are no matters pending that we currently believe are material. There can be no assurance that existing or future legal proceedings arising in the ordinary course of business or otherwise will not have a material adverse effect on our business, financial condition or results of operations.
Item 1A. Risk Factors
Except as set forth below, there have been no material changes from the risk factors disclosed in Part I, Item 1A. “Risk Factors” of our 2024 Annual Report. The risk factors described in our 2024 Annual Report, as well as other information set forth in this Quarterly Report on Form 10-Q, could materially adversely affect our business, financial condition, results of operations and prospects, and should be carefully considered. The risks and uncertainties that we face, however, are not limited to those described in the 2024 Annual Report. Additional risks and uncertainties not presently known to us or that we currently believe to be immaterial may also adversely affect our business and the trading price of our securities.
Risks Related to Our Business and Our Industry
Disruptions in the supply of the materials and components used in manufacturing our products or the sterilization of our products by third-party suppliers could adversely affect our business, financial condition and results of operations.
Our suppliers purchase many of the materials and components used in the manufacture of our products from third-party suppliers. Certain of these materials and components can only be obtained from a single source or a limited number of sources due to quality considerations, expertise, costs or constraints resulting from regulatory requirements. In certain cases, our suppliers may not be able to establish additional or replacement suppliers for such materials or components or outsourced activities in a timely or cost-effective manner. A reduction or interruption in the supply of materials or components used in manufacturing our products, such as due to one or more suppliers experiencing reductions in operations and/or worker absences due to health epidemics, an inability to timely develop and validate alternative sources if required, or a significant increase in the price of such materials or components, such as that caused by tariffs and retaliatory countermeasures, inflation or rising interest rates, could adversely affect our business, financial condition and results of operations. For example, certain of our products require titanium, which is sourced from third-party suppliers. While the titanium required for such products is not directly sourced from Russia, the current geopolitical events involving Russia and Ukraine are negatively impacting the wider titanium supply chain. These geopolitical events and related factors and results, including related sanctions, may negatively impact the ability of our suppliers’ third-party supply sources to timely supply titanium to our suppliers and may increase or result in additional costs to us. The imposition of tariffs on titanium sourced from Canada or elsewhere could further exacerbate these challenges and increase the cost of our implants.
In addition, many of our products require sterilization prior to sale, and our suppliers use contract sterilizers to perform this service. To the extent that these contract sterilizers are unable to sterilize our products, whether due to capacity, availability of materials for sterilization, regulatory or other constraints, including reductions in operations and/or worker absences due to health epidemics, we may be unable to transition to other contract sterilizers, sterilizer locations or sterilization methods in a timely or cost effective manner or at all, which could have a material impact on our results of operations and financial condition.
Various factors outside our direct control may adversely affect manufacturing, sterilization, and distribution of our products.
The manufacture, sterilization, and distribution of our products is challenging. Changes that our suppliers may make outside the purview of our direct control can have an impact on our processes, quality of our products, and the successful delivery of products to our customers. Mistakes and mishandling are not uncommon and can affect supply and delivery. Some of these risks include:
•failure to complete sterilization on time or in compliance with the required regulatory standards;
•transportation and import and export risk;
•delays in analytical results or failure of analytical techniques that we depend on for quality control and release of products;
•large-scale epidemics of communicable diseases;
•supply chain disruptions, including those caused by material and labor supply shortages, tariffs and retaliatory countermeasures, and prolonged inflation;
•natural disasters, labor disputes, financial distress, raw material availability, issues with facilities and equipment, or other forms of disruption to business operations affecting our manufacturers or suppliers; and
•latent defects that may become apparent after products have been released and that may result in a recall or field safety corrective action with respect to such products.
•If any of these risks were to materialize, our ability to provide our products to customers on a timely basis could be adversely impacted.
Risks Related to Ownership of Our Common Stock
The price of our common stock may be volatile, and the value of an investment in our common stock could decline.
Medical device stocks have historically experienced volatility, and the trading price of our common stock may fluctuate substantially. These fluctuations could cause our stockholders to lose all or part of their investment in our common stock. Factors that could cause fluctuations in the trading price of our common stock include the following:
•changes in interest rates, tariff policy investor risk appetite and other macroeconomic factors impacting the market for securities issued by medical device companies;
•the risk of inflation, interest rate increases, economic downturn or instability and other macroeconomic factors impacting patients’ economic ability and likelihood of undergoing elective procedures, whether real or as perceived by investors;
•actual or anticipated changes or fluctuations in our results of operations;
•the impact of infectious diseases, and measures taken to combat them, on our business;
•results of our clinical trials and that of our competitors’ products;
•regulatory actions with respect to our products or our competitor’s products;
•announcements of new offerings, products, services or technologies, commercial relationships, acquisitions, or other events by us or our competitors;
•price and volume fluctuations in the overall stock market from time to time;
•significant volatility in the market price and trading volume of healthcare companies, in general, and of companies in the medical device industry in particular;
•fluctuations in the trading volume of our shares or the size of our public float;
•negative publicity;
•whether our results of operations meet the expectations of securities analysts or investors or those expectations change;
•litigation involving us, our industry, or both;
•regulatory developments in the United States, foreign countries, or both;
•lock-up releases and sales of large blocks of our common stock;
•additions or departures of key employees or scientific personnel; and
•general economic conditions and trends.
In addition, if the market for healthcare stocks or the stock market, in general, experience a further loss of investor confidence, the trading price of our common stock could decline for reasons unrelated to our business, results of operations, or financial condition. The trading price of our common stock might also decline in reaction to events that affect other companies in our industry even if these events do not directly affect us. In the past, following periods of volatility in the market price of a company’s securities, securities class action litigation has often been brought against that company. If our stock price is volatile, we may become the target of securities litigation. Securities litigation could result in substantial costs and divert our management’s attention and resources from our business. This could have a material adverse effect on our business, results of operations, and financial condition.
Risks Related to Our Legal and Regulatory Environment
Inadequate funding for the FDA and other government agencies, disruptions or diminishment of the workforces of these government agencies, or a work slowdown or stoppage at those agencies as part of a broader federal government shutdown, or comparable scenarios with foreign regulatory authorities, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner, or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
The ability of the FDA to review and approve or clear new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes and other events that may otherwise affect the FDA’s ability to perform routine functions. Disruptions at FDA and other agencies may also slow the time necessary for new product applications to be reviewed and/or approved by necessary government agencies, which could adversely affect our business. For example, in recent years, including for 35 days beginning on December 22, 2018, the U.S. government shut down several times and certain regulatory agencies, such as the FDA, had to furlough critical employees and stop critical activities. Average review times at FDA have fluctuated in recent years as a result. In addition, government funding of other government agencies on which our operations may rely is subject to the political process, which is inherently fluid and unpredictable. More recently, the FDA and other governmental agencies in the U.S. have been subject to sudden and dramatic reductions in the workforces due to termination of probationary employees, broad-based offers of early retirement to government employees and other efforts led by the Department of Government Efficiency under the current presidential administration. The impact of these reductions to the federal workforce remains to be seen.
If a prolonged government shutdown occurs, continued reductions in the U.S. governmental workforce, or if global health concerns or other political or world events prevent the FDA or other regulatory authorities from conducting their regular reviews or other regulatory activities, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Future government shutdowns or delays could also impact our ability to access the public markets and obtain capital to fund the growth of our operations. Similar considerations and concerns apply to foreign regulatory authorities.
Our ability to access credit on favorable terms, if necessary, for the funding of our operations and capital projects may be limited due to changes in credit markets.
In the past, the credit markets and the financial services industry have experienced disruption characterized by the bankruptcy, failure, collapse or sale of various financial institutions, increased volatility in securities prices, diminished liquidity and credit availability and intervention from the U.S. and other governments. Continued concerns about the systemic impact of potential long-term or widespread downturn, energy costs, geopolitical issues, tariff policy and potential trade wars, the availability and cost of credit, the global commercial and residential real estate markets and related mortgage markets and reduced consumer confidence have contributed to increased market volatility. The cost and availability of credit has been and may continue to be adversely affected by these conditions. We cannot be certain that funding for our capital needs will be available from our existing financial institutions and the credit markets if needed, and if available, to the extent required and on acceptable terms. On November 8, 2024, we entered into a Third Amendment to Loan and Security Agreement (the “Third Amendment”) with Silicon Valley Bank, a division of First-Citizens Bank & Trust Company (“First-Citizen”), which amends the Company’s Loan and Security Agreement, dated as of August 12, 2021 (the “Original Loan Agreement”), as amended by that certain First Amendment to Loan and Security Agreement, dated as of January 6, 2023 (the “First Amendment”) and that certain Second Amendment to Loan and Security Agreement, dated as of January 25, 2024 (the “Second Amendment” and collectively with the Original Loan Agreement, as amended by the First Amendment, Second Amendment and Third Amendment, the “Third Amended Loan Agreement”). The Third Amendment Term Loan extended by First-Citizens to us pursuant to the current Third Amended Loan Agreement terminates and matures on September 1, 2029, and if we cannot renew or refinance this Third Amendment Term Loan, if needed at such time, or obtain funding when needed, in each case on acceptable terms, such conditions may have an adverse effect on our ability to operate our business. See “Note 7. Borrowings” to the “Notes to Consolidated Financial Statements” included in this report for additional information.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not Applicable.
Item 5. Other Information
On May 5, 2025, our Board of Directors approved, at the recommendation of the Compensation Committee of the Board of Directors, an amendment to the Participation Agreement of Laura Francis, our Chief Executive Officer, for use with our Severance Benefit Plan, to provide for the following enhanced benefits upon termination without Cause or for Good Reason (each, as defined in the Severance Benefit Plan) within three months prior to or one year following a Change in Control (as defined in the Severance Benefit Plan): a lump-sum cash severance amount equal to 24 months of Ms. Francis’s then effective base salary, a target bonus equals to 1.5 times Ms. Francis’s target annual cash bonus, 18 months’ continued benefits and full acceleration of Ms. Francis’s outstanding equity awards, in each case subject to the execution and non-revocation of a release of claims. In the event of a termination other than for Cause and not in connection with a Change in Control, the severance payments include a lump sum cash payment equal to 18 months’ base salary and benefit coverage for 18 months.
Item 6. Exhibits
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| | | | Incorporation By Reference | | |
Exhibit Number | | Description | | Form | | SEC File No. | | Exhibit/ Reference | | Filing Date |
| | | | | | | | | | |
3.1 | | | | 8-K | | 001-38701 | | 3.1 | | 10/19/2018 |
3.2 | | | | 8-K | | 001-38701 | | 3.1 | | 9/20/2023 |
3.3 | | | | 8-K | | 001-38701 | | 3.1 | | 6/26/2024 |
4.1 | | | | S-1/A | | 333-227445 | | 4.1 | | 10/5/2018 |
4.2 | | Reference is made to Exhibits 3.1 and 3.2. | | | | | | | | |
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31.1* | | | | | | | | | | |
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32.1** | | | | | | | | | | |
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101.INS* | | Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. | | | | | | | | |
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101.SCH* | | Inline XBRL Taxonomy Extension Schema Document. | | | | | | | | |
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101.CAL* | | Inline XBRL Taxonomy Extension Calculation Linkbase Document. | | | | | | | | |
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101.DEF* | | Inline XBRL Taxonomy Extension Definition Linkbase Document. | | | | | | | | |
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101.LAB* | | Inline XBRL Taxonomy Extension Label Linkbase Document. | | | | | | | | |
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101.PRE* | | Inline XBRL Taxonomy Extension Presentation Linkbase Document. | | | | | | | | |
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104 | | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) | | | | | | | | |
* Filed herewith.
** Furnished herewith. Exhibit 32.1 is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall such exhibit be deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise specifically stated in such filing.
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized, in Santa Clara, California, on May 6, 2025.
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| | SI-BONE, Inc. |
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Date: | May 6, 2025 | By: | /s/ Laura A. Francis |
| | | Laura A. Francis |
| | | Chief Executive Officer |
| | | (Duly Authorized Officer and Principal Executive Officer) |
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| | SI-BONE, Inc. |
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Date: | May 6, 2025 | By: | /s/ Anshul Maheshwari |
| | | Anshul Maheshwari |
| | | Chief Financial Officer |
| | | (Duly Authorized Officer and Principal Financial and Accounting Officer) |