SI-BONE Inc
For the period ended Mar 31, 2025. Filed May 6, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed May 6, 2025
SIBN$24.24-0.1%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-11-12.
0001459839-24-000077
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-06.
0001459839-25-000061
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 108 previous paragraphs and 91 current paragraphs.
58 unchanged; 32 reworded; 0 added; 14 removed; 4 previous and 1 current paragraphs rearranged.
Tables are not compared: 10 previous and 7 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Removed paragraphs (14)
Previous report
In May 2023, we received a total of $83.7 million of net proceeds from the offering of 3,775,000 shares of our common stock, and the exercise of the underwriter's option to purchase an additional 566,250 shares of our common stock, at a public offering price of $22.00 per share. Of these shares, 272,753 shares were offered by a selling stockholder and did not result in any proceeds to us.
Previous report
We maintain a commitment to employee retention by leveraging insights from exit interviews and engagement surveys to continuously enhance the workplace experience.
Previous report
Interest Expense. The interest expense for the three months ended September 30, 2024 remained consistent as compared to the three months ended September 30, 2023, due to relatively stable interest rates associated with the First-Citizens Term Loan year over year.
Previous report
Comparison of the Nine Months Ended September 30, 2024 and 2023
Previous report
Revenue. The increase in revenue for the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023 was primarily driven by a $17.5 million increase in our U.S. revenue due to the increase in case volumes due to our expanded product portfolio and $0.6 million increase in international revenue due to the increase in case volumes.
Previous report
Gross Profit and Gross Margin. Gross profit increased $12.6 million for the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023, mainly driven by higher revenue. The gross margin was 79% for the nine months ended September 30, 2024 as compared to 81% for the nine months ended September 30, 2023. Gross margin decreased in the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023, primarily due to changes in procedure and product mix.
Previous report
Operating Expenses:
Previous report
Sales and Marketing Expenses. The increase in sales and marketing expenses for the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023 was primarily due to a $2.0 million increase in commissions driven by higher revenues, $1.7 million increase in training and travel costs to support the expansion of our sales and marketing activities, and a $0.8 million increase in employee-related costs and stock-based compensation driven by an increase in headcount within sales and marketing departments.
Previous report
Research and Development Expenses. The increase in research and development expenses for the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023 was primarily due to a $1.0 million increase in research, regulatory, and consulting fees to support our product development activities and a $0.8 million increase in employee-related costs and stock-based compensation due to an increase in headcount within research and development departments.
Previous report
General and Administrative Expenses. The increase in general and administrative expenses for the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023 was primarily due to a $1.4 million increase in employee-related costs and stock-based compensation due to an increase in headcount within general and administrative departments, a $0.2 million increase in audit fees related to the audit of our financial statements and the audit of our internal control over financial reporting.
Previous report
Interest Income. The increase in interest income for the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023 was primarily due to higher interest earned on our investments in marketable securities, primarily as a result of higher interest rates earned.
Previous report
In May 2023, we received a total of $83.7 million of net proceeds after deducting the underwriting discounts and commissions from the public offering of our common stock.
Previous report
On March 10, 2023, we violated certain terms of the Amended Loan Agreement by opening bank accounts with another financial institution and transferring funds from SVB. We entered into a letter agreement with Silicon Valley Bridge Bank waiving enforcement of this covenant and providing us the right to hold a portion of our cash at other financial institutions. A future violation of any covenants could result in a default under the Second Amended Loan Agreement that would permit First-Citizens to restrict our ability to further access the Revolving Line of Credit for loans and require the immediate repayment of any outstanding loans under the agreement. As of September 30, 2024, we were in compliance with all debt covenants.
Previous report
The Second Amended Loan Agreement contains customary events of default, including bankruptcy, the failure to make payments when due, the occurrence of a material impairment on First-Citizens' security interest over the collateral, a material adverse change, the occurrence of a default under certain other indebtedness of our company and our subsidiaries, the rendering of certain types of judgments against us and our subsidiaries, the revocation of certain government approvals, violation of covenants, and incorrectness of representations and warranties in any material respect. In addition, the Second Amended Loan Agreement contains a financial covenant which requires us to maintain, at all times during which we are subject to financial covenants under the Second Amended Loan Agreement is in effect, certain net revenue levels as agreed upon by us and First-Citizens. If we do not comply with the various covenants under the Second Amended Loan Agreement and an event of default occurs under the Second Amended Loan Agreement, the interest rate on outstanding amounts can increase by 3% and First-Citizens may, subject to various customary cure rights, decline to provide additional advances under the Revolving Line, require the immediate payment of all loans and other amounts outstanding under the Second Amended Loan Agreement, and foreclose on all collateral.
Reworded paragraphs (32)
Previous wording
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 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.
Current wording
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.
Previous wording
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 September 30, 2024, over 110,000 procedures have been performed using our products by over 4,100 physicians in the United States and 38 other countries since we introduced iFuse in 2009.
Current wording
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.
Previous wording
As of September 30, 2024, our U.S. sales force consisted of 82 territory sales managers and 76 clinical support specialists directly employed by us and 227 third-party sales agents, compared to 83 territory sales managers and 68 clinical support specialists directly employed by us and 160 third-party sales agents as of September 30, 2023. As of September 30, 2024, our international sales force consisted of 11 sales representatives directly employed by us and a total of 29 third-party sales agents and resellers, compared to 13 sales representatives directly employed by us and a total of 30 third-party sales agents and resellers as of September 30, 2023.
Current wording
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.
Previous wording
As of September 30, 2024, over 20 percent of our procedures for sacroiliac joint dysfunction were performed at ambulatory surgery centers, or ASCs. With the steady increase in the numbers of minimally invasive procedures, including sacroiliac joint fusion procedures, being performed at ASCs, 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.
Current wording
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.
Previous wording
We utilize 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.
Current wording
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.
Previous wording
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 September 30, 2024 and 2023, in the United States more than 3,000 and 2,400 physicians, respectively, have been trained on our products and have treated at least one patient. Outside the United States, as of September 30, 2024 and 2023, more than 1,100 and 940 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 approximately 1,800 surgical residents and fellows in over 250 academic programs in the United States.
Current wording
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.
Previous wording
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 to obtaining stabilization and /or fusion.
Current wording
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.
Previous wording
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 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 are no longer actively recruiting patients in our SAFFRON study and anticipate publishing follow-up results in 2025.
Current wording
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.
Previous wording
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 nine months ended September 30, 2024, we spent $12.7 million on research and development, equating to 11% of our revenue. During the nine months ended September 30, 2023, we spent $10.9 million on research and development, equating to 11% of our revenue.
Current wording
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.
Previous wording
Our ability to recruit, develop and retain highly skilled talent is a significant determinant of our success. To attract, retain, and develop 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.
Current wording
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.
Previous wording
In addition to ensuring workforce diversity and 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.
Current wording
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.
Previous wording
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 September 30, 2024, our trailing twelve month average revenue per territory sales manager was approximately $1.8 million.
Current wording
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.
Previous wording
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 office-based labs or 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.
Current wording
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.
Previous wording
Interest expense is primarily related to borrowings, amortization of debt issuance costs, and accretion of final fees on the First-Citizens Term Loan.
Current wording
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.
Previous wording
Revenue. The increase in revenue for the three months ended September 30, 2024 as compared to the three months ended September 30, 2023 was primarily driven by a $6.0 million increase in our U.S. revenue from increased case volumes due to our expanded product portfolio and $0.3 million increase in international revenue due to the increase in case volumes.
Current wording
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.
Previous wording
Gross Profit and Gross Margin. Gross profit increased $4.9 million for the three months ended September 30, 2024 as compared to the three months ended September 30, 2023, mainly driven by higher revenue. The gross margin was 79% for the three months ended September 30, 2024 consistent with the gross margin of 79% for the three months ended September 30, 2023.
Current wording
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.
Previous wording
Sales and Marketing Expenses. The increase in sales and marketing expenses for the three months ended September 30, 2024 as compared to the three months ended September 30, 2023 was primarily due to a $0.5 million increase in commissions driven by higher revenues and $0.4 million increase in training to support the expansion of our sales and marketing activities.
Current wording
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.
Previous wording
General and Administrative Expenses. The increase in general and administrative expenses for the three months ended September 30, 2024 compared to the three months ended September 30, 2023 was primarily due to a $0.4 million increase in employee-related costs and stock-based compensation due to an increase in headcount within general and administrative departments.
Current wording
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.
Previous wording
Interest Expense. The increase in interest expense for the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023 was primarily due to higher interest rates associated with the First-Citizens Term Loan.
Current wording
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.
Previous wording
As of September 30, 2024, we had cash and marketable securities of $150.8 million as compared to $166.0 million as of December 31, 2023. We have financed our operations primarily through the sale of our common stock in our public offerings and debt financing arrangements. As of September 30, 2024, we had $36.2 million in outstanding debt as compared to $36.1 million as of December 31, 2023.
Current wording
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.
Previous wording
As of September 30, 2024, we had an accumulated deficit of $426.9 million as compared to $400.4 million as of December 31, 2023. During the nine months ended September 30, 2024, we incurred a net loss of $26.4 million. During the years ended December 31, 2023 and 2022, we incurred a net loss of $43.3 million and $61.3 million, respectively, and expect to incur additional losses in the future. We have not achieved positive cash flow from operations to date.
Current wording
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.
Previous wording
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 economic impact of a potential future disruptions in the healthcare operating environment and uncertainties affecting the economic and capital markets environment and the financial services industry pose risks and uncertainties to our future available capital resources. Further, 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 the following: (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 line introduced typically requires the purchase of consumable implant inventory as well as investment in a fleet of instrument trays required to support procedures nationwide.
Current wording
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.
Previous wording
Our outstanding debt is related to a term loan pursuant to the Loan and Security Agreement dated August 12, 2021 (the “Original Loan Agreement”), entered into by us and Silicon Valley Bank (“SVB” or “Lender”). Pursuant to the Original Loan Agreement, SVB provided a term loan in the aggregate principal amount of $35.0 million to us (the “Original Term Loan”).
Current wording
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”).
Previous wording
On January 6, 2023, we entered into a First Amendment to Loan and Security Agreement (the “Amendment” and together with the Original Loan Agreement, the “Amended Loan Agreement”) with SVB, which increased our Original Term Loan facility of $35.0 million to $36.0 million. Upon entry into the Amendment, we borrowed $36.0 million pursuant to a new term loan (the “Term Loan”), which was substantially used to repay in full the Original Term Loan, and we also secured a revolving credit facility in an aggregate principal amount of up to $15.0 million (the “Revolving Line”) and an uncommitted accordion term loan in an aggregate principal amount of up to $15.0 million, which accordion may be approved by the Lender, solely in its discretion, upon our request. The Term Loan matures on December 1, 2027 (the “Term Loan Maturity Date”). Interest on the Term Loan will be payable monthly at a floating annual rate set at the greater of (i) the prime rate as published in the Wall Street Journal plus 0.5% or (ii) 6.75%. Commencing on July 1, 2025, we will be required to make monthly principal Term Loan amortization payments. A final fee payment of 2% of the original principal amount of the Term Loan is due upon the earlier of the Term Loan Maturity Date, termination of the Amended Loan Agreement, acceleration by the Lender following an event of default, or prepayment of the Term Loan. We may elect to prepay the Term Loan in whole prior to the Term Loan Maturity Date subject to a prepayment fee equal to 2% of the principal amount of the Term Loan prepaid at such time. No prepayment fee would be due if the Term Loan is refinanced by the Lender. Pursuant to the terms of the Amended Loan Agreement, revolving loans may be borrowed, repaid and reborrowed until the maturity date, which will be July 6, 2025 (the “Revolving Line Maturity Date”). Borrowings under the Revolving Line are based on 80% of eligible domestic accounts receivable borrowing base. Interest on the outstanding balance of the Revolving Line will be payable monthly at a floating annual rate set at the greater of the prime rate as published in the Wall Street Journal or 6.25%. Interest on borrowings is due monthly and any principal balance is due on the Revolving Line Maturity Date, provided that when Revolving Line Advances are outstanding, in the event we do not maintain an adjusted quick ratio of at least 1.5 to 1.0, then falling below such threshold will allow the Lender to apply accounts receivable collections to outstanding Revolving Line borrowings. We will pay a total commitment fee of $187,500 on account of the Revolving Line payable in installments, but fully earned at close. We will also be required to pay a fee of $150,000 if we terminate the Amended Loan Agreement or the Revolving Line prior to Revolving Line Maturity Date, or if the Lender terminates the Loan Agreement or the Revolving Line following an event of default. No termination fee would be due if the Revolving Line is replaced with a…
Excerpt shortened here; the source contains the full paragraph.
Current wording
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").
Previous wording
On March 14, 2023 all of SVB’s assets and liabilities, including all of SVB’s rights as the lender pursuant to the Amended Loan Agreement, were assigned to Silicon Valley Bridge Bank. On March 27, 2023, all of Silicon Valley Bridge Bank’s assets and liabilities were assigned and assumed by First-Citizens Bank & Trust Company (“First-Citizens”). On January 25, 2024, the Company entered into a Second Amendment to Loan and Security Agreement with First-Citizens which amends the Company's Amended Loan Agreement (the “Second Amendment” and together with the Amended Loan Agreement, the “Second Amended Loan Agreement”). The Second Amendment revised certain provisions related to financial covenants and the periods in which the covenants apply. No amounts were outstanding under the Revolving Line as of September 30, 2024.
Current wording
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.
Previous wording
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 Term Loan. The Company also paid a certain final payment due relative to such prior Term Loan. The Third Amendment sets the maturity date for the Third Amendment Term Loan to September 1, 2029 (the "Third Amendment Term Loan Maturity Date"), and defers 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 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 it 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 the covenants apply, and First-Citizens and the Company also terminated the Revolving Line and an uncommitted accordion term loan provision.
Current wording
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.
Previous wording
(1)Represents the principal obligations and the final fee at maturities of our First-Citizens Term Loan.
Current wording
(1)Represents the principal obligations of our First-Citizens Third Amendment Term Loan.
Previous wording
(2)Represents the future interest obligations on our First-Citizens Term Loan estimated using an interest rate of 8.50% as of September 30, 2024.
Current wording
(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.
Previous wording
This compares to $49.2 million of contractual obligations as of December 31, 2023.
Current wording
This compares to $48.1 million of contractual obligations as of December 31, 2024.
Previous wording
Net cash used in operating activities for the nine months ended September 30, 2024 of $13.6 million resulted from cash outflows due to a net loss of $26.4 million, adjusted for $21.0 million of non-cash items, and cash outflows from net changes in operating assets and liabilities of $8.2 million. Net cash used in operating activities for the nine months ended September 30, 2023 of $16.4 million resulted from cash outflows due to a net loss of $32.4 million, adjusted for $21.2 million of non-cash items, and cash outflows from changes in operating assets and liabilities of $5.3 million. The decrease in net loss, net of non-cash items for the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023 was mainly due to increased revenues. Net cash outflows from changes in operating assets and liabilities for the nine months ended September 30, 2024 was primarily due to higher accounts receivable due to timing of collections, higher inventory due to new product introductions, higher account payables and lower accrued liabilities attributable to the normal timing of expenses. Net cash outflows from changes in operating assets and liabilities for the nine months ended September 30, 2023 was primarily due to higher inventory due to the inventory build-up related to our implants, and lower account payables attributable to the normal course timing of expenses.
Current wording
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.
Previous wording
Net cash provided by investing activities in the nine months ended September 30, 2024 was $8.3 million as compared to cash used in investing activities of $40.9 million in the nine months ended September 30, 2023. Net cash provided by investing activities for the nine months ended September 30, 2024 consisted of maturities of our marketable securities net of purchases of $16.5 million, and purchases of property and equipment of $8.2 million primarily related to individual components in instrument sets to support revenue growth. Net cash used in investing activities for the nine months ended September 30, 2023 consisted of
Current wording
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.
Previous wording
Cash provided by financing activities in the nine months ended September 30, 2024 was $2.0 million resulting from the issuance of common stock under our stock-based incentive compensation plans. This compares to $90.1 million resulting from proceeds of $83.7 million from the issuance of common stock under our follow-on public offering, proceeds of $5.7 million from the issuance of common stock under our stock-based incentive compensation plans, and net proceeds of $0.7 million from the refinancing of our Term Loan with First-Citizens.
Current wording
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.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
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.
Rearranged previous paragraphs (4)
Previous report — wording carried elsewhere
Revenue, Cost of Goods Sold, Gross Profit, and Gross Margin:
Previous report — wording carried elsewhere
Interest and Other Income (Expense), Net:
Previous report — wording carried elsewhere
Other Income (Expense), Net. The change in other income (expense), net for the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023 was primarily due to foreign currency fluctuations.
Previous report — wording carried elsewhere
purchases of our marketable securities net of maturities of $34.2 million, and purchases of property and equipment of $6.7 million primarily related to individual components in instrument sets to support revenue growth, as well as leasehold improvements made to the building used for research and development and warehouse space in Santa Clara.