SI-BONE(SIBN)
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SI-BONE, Inc. Reports Financial Results for the Third Quarter 2025 and Raises 2025 Guidance
Globenewswire· 2025-11-10 21:09
Core Insights - SI-BONE, Inc. reported a strong financial performance in Q3 2025, with worldwide revenue growth of approximately 21% and a positive adjusted EBITDA margin of $2.3 million, indicating robust demand for its medical devices [1][7][8]. Financial Performance - Worldwide revenue reached $48.7 million, a 20.6% increase from $40.3 million in Q3 2024 [4][8]. - U.S. revenue was $46.4 million, reflecting a 21.2% increase from $38.3 million in the same period last year, driven by strong procedure demand [4][8]. - International revenue was $2.3 million, a 10.2% increase from $2.1 million in Q3 2024, attributed to the successful launch of the TORQ product in European markets [4][8]. Profitability Metrics - Gross profit for the quarter was $38.8 million, up 21.8% from $31.9 million in Q3 2024, with a gross margin of 79.8%, an improvement of 75 basis points year-over-year [5][8]. - Operating expenses increased by 11.9% to $44.2 million, primarily due to higher commercial activities and new product rollouts [6][8]. - The operating loss improved by 29.5% to $5.4 million compared to a loss of $7.6 million in Q3 2024 [6][8]. Net Loss and Cash Flow - The net loss for the quarter was $4.6 million, or $0.11 per diluted share, an improvement of 30.6% from a net loss of $6.6 million, or $0.16 per diluted share, in Q3 2024 [7][8]. - Positive cash from operating activities was reported at $2.3 million, indicating effective cash management [8]. Guidance and Future Outlook - For fiscal 2025, SI-BONE expects worldwide revenue to be between $198 million and $200 million, representing year-over-year growth of approximately 18% to 20% [10][11]. - The company anticipates a gross margin of around 79.5% for the full year 2025, reflecting continued operational efficiency [10][11]. Operational Highlights - The number of active U.S. physicians increased by 27% to 1,530, indicating growing adoption of SI-BONE's technologies [8]. - The trailing 12-month average revenue per territory rose by 16% to $2.1 million, showcasing improved sales performance [8].
SI-BONE To Report Third Quarter 2025 Financial Results on November 10, 2025
Globenewswire· 2025-10-20 20:09
Core Insights - SI-BONE, Inc. will report its financial results for Q3 2025 on November 10, 2025, after market close [1] - A conference call will be held at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time to discuss the results [1] Company Overview - SI-BONE is a global leader in developing technologies for surgical treatment of sacropelvic disorders, having pioneered minimally invasive SI joint surgery in 2009 with the iFuse Implant System [3] - The company has supported over 4,600 physicians in performing nearly 130,000 procedures, backed by over 175 peer-reviewed publications, including four randomized controlled trials [3] - SI-BONE has expanded its offerings to adjacent markets, including adult deformity, spinopelvic and sacropelvic fixation, and pelvic trauma [3]
DATA BREACH ALERT: Edelson Lechtzin LLP is Investigating Claims on Behalf of SI-Bone, Inc. Customers Whose Data May Have Been Compromised
Globenewswire· 2025-10-03 16:20
Core Points - SI-Bone, Inc. experienced a data breach on or about October 1, 2025, which has led to an investigation into data privacy claims [1][3] - The breach may have exposed sensitive personal information, including names, Social Security numbers, driver's license numbers, addresses, medical information, and health insurance information [3] - Edelson Lechtzin LLP is investigating a potential class action lawsuit for individuals whose sensitive personal data may have been compromised [4] Company Overview - SI-Bone, Inc. is based in Santa Clara, California, and specializes in developing minimally invasive devices for treating sacropelvic conditions, particularly SI joint pain [2] Legal Context - Edelson Lechtzin LLP is a national class action law firm that focuses on various litigation areas, including data breaches, securities fraud, antitrust violations, and consumer fraud [5]
SI-BONE, Inc. (SIBN) Presents at Morgan Stanley 23rd Annual Global Healthcare Conference
Seeking Alpha· 2025-09-09 15:51
Group 1 - The company has evolved from focusing solely on the sacropelvic joint space to becoming a broader platform in the medical industry [1][2] - The company was established with a specific focus on the sacroiliac (SI) joint, which is the largest joint in the human body and previously lacked a surgical solution [2][3] - The CEO has been with the company for over 10 years, starting as CFO in 2015, indicating a strong leadership continuity [2]
SI-BONE, Inc. (SIBN) Presents At Morgan Stanley 23rd Annual Global Healthcare Conference (Transcript)
Seeking Alpha· 2025-09-09 15:51
Group 1 - The company has evolved from focusing solely on the sacropelvic joint space to becoming a broader platform in the medical field [1][2] - The company was initially established to address the lack of surgical solutions for the sacroiliac (SI) joint, which is the largest joint in the human body [2][3] - The CEO has been with the company for over 10 years, starting as CFO in 2015, indicating a strong leadership continuity [2]
SI-BONE (NasdaqGM:SIBN) FY Conference Transcript
2025-09-09 12:00
Summary of SI-BONE FY Conference Call (September 09, 2025) Company Overview - **Company**: SI-BONE (NasdaqGM:SIBN) - **Industry**: Medical Devices, specifically focused on orthopedic solutions for sacropelvic conditions Key Points and Arguments Business Evolution and Market Position - **Initial Focus**: SI-BONE started as a private company focused on the sacroiliac (SI) joint, which lacked surgical solutions. The company identified an unmet clinical need and developed capabilities to address it [4][5] - **Current Status**: SI-BONE has evolved into a diversified high-growth platform, launching breakthrough devices for various sacropelvic needs [6] - **Market Leadership**: The company claims to be the undisputed leader in the SI joint space, with significant market share and clinical data supporting its products [5] Financial Performance - **Revenue**: Expected to generate nearly $200 million in revenues for the year, with an average annual growth rate of over 20% since its IPO [7] - **Profitability**: Achieved adjusted EBITDA profitability for the last three quarters and positive operating cash flow for the first time in the last quarter [7] Product Development and Innovation - **Breakthrough Devices**: Launched the iFuse Bedrock Granite for pelvic fixation and a new device for pelvic ring fractures, with plans for further innovations [6][12] - **Clinical Evidence**: Over 180 peer-reviewed papers and multiple randomized controlled trials support the safety and efficacy of their solutions [5] - **Market Opportunity**: The total addressable market (TAM) for SI joint dysfunction is estimated at 280,000 potential cases annually, with only about 10% market penetration currently [13] Growth Strategy - **Future Plans**: Aiming for $500 million in sales, focusing on addressing patients with poor bone quality and expanding product offerings [10][49] - **Surgeon Engagement**: The company is working to increase the number of procedures performed by existing surgeons and penetrate a larger number of target physicians [40][42] Reimbursement and Economic Factors - **Reimbursement Improvements**: Anticipated reimbursement increases of 20-30% for certain procedures starting October 1, 2025, which could significantly impact growth [36] - **Economic Model**: The asset-light model with high gross margins (approaching 80%) allows for better financial performance compared to peers in the spine category [14][26] Market Dynamics and Competitive Landscape - **Differentiation**: SI-BONE differentiates itself from competitors by focusing on unmet clinical needs and providing strong clinical evidence, which allows for premium pricing [26] - **Surgeon Utilization**: The company is seeing double-digit growth in surgeon engagement, with a focus on increasing the number of procedures per surgeon [40][41] Management and Leadership Changes - **Executive Team Stability**: The average tenure of the executive team is over 10 years, with a recent promotion of Nicholas Kerr to Chief Commercial Officer to drive future growth [43][46] Long-term Outlook - **Sustained Growth**: The company is optimistic about its growth trajectory, with plans for continued innovation and expansion into new markets [48][49] Additional Important Insights - **Patient Impact**: The company emphasizes the importance of improving patient mobility and quality of life through its innovative solutions [20][24] - **Educational Focus**: SI-BONE has taken on the responsibility of educating surgeons about the SI joint and its treatment options, which has been crucial for market development [5] This summary encapsulates the key points discussed during the SI-BONE FY Conference Call, highlighting the company's strategic direction, financial performance, and market opportunities.
SI-BONE to Present at Morgan Stanley 23rd Global Healthcare Conference on September 9, 2025
Globenewswire· 2025-08-26 20:03
Company Participation - SI-BONE, Inc. will participate in the Morgan Stanley 23rd Annual Global Healthcare Conference in New York on September 9, 2025 [1] - Management will host a fireside chat at 4:00 a.m. Pacific Time / 07:00 a.m. Eastern Time [1] Investor Information - Investors can register for the conference call via a provided link and access the live audio webcast on the company's website [2] - The webcast will be archived for at least 90 days post-event [2] Company Overview - SI-BONE is a leader in developing technologies for surgical treatment of sacropelvic disorders, having pioneered minimally invasive SI joint surgery in 2009 with the iFuse Implant System [3] - The company has supported over 4,600 physicians in nearly 130,000 procedures, backed by over 175 peer-reviewed publications including four randomized controlled trials [3] - SI-BONE has expanded its offerings to adjacent markets such as adult deformity, spinopelvic and sacropelvic fixation, and pelvic trauma [3]
SI-BONE (SIBN) FY Conference Transcript
2025-08-12 20:00
Summary of SI-BONE (SIBN) FY Conference Call - August 12, 2025 Company Overview - **Company**: SI-BONE, a pioneer in sacropelvic solutions with an expanding product portfolio addressing unmet clinical needs [1][2] Key Financial Performance - **Q2 Performance**: - Worldwide growth of 22% and U.S. growth of 23% [3][4] - Procedure volume growth of 25% [4] - Consistent 20% CAGR since IPO, with accelerated growth in the last three years [4][5] - Gross margin expectations raised to 70.5% - 79% for the full year, currently at close to 80% [6] - Achieved positive adjusted EBITDA for three consecutive quarters and cash flow breakeven [6][10] Growth Drivers - **Broad-Based Growth**: - Double-digit growth in procedure volume across all modalities and call points [5][8] - Increase in active physicians to 1,440, indicating strong future growth potential [7] - **Product Adoption**: - Strong adoption of Granite 9.5 and TNT products, with additional capacity planned [7][11] - **Market Opportunities**: - Anticipated strong performance in Q4 and into 2026 due to new product launches and increased surgical capacity [11][17] Market Size and Addressable Market - **Total Addressable Market (TAM)**: - SI joint dysfunction market estimated at $2.5 billion with 300,000 target patients annually [19] - Adult deformity market approximately $400 million and degenerative spine market around $1 billion [20] - Overall market potential close to $4 billion with 5 million target procedures annually [22] Product Pipeline and Innovations - **Upcoming Products**: - NextGen SI joint solution expected to launch in late Q1 2026, targeting interventionalists [31][34] - Second breakthrough device submission planned for the second half of 2026 [35][38] - **R&D Focus**: - Active pipeline with emphasis on addressing unmet clinical needs and maintaining high gross margins [42][43] Reimbursement and Regulatory Environment - **Favorable Reimbursement**: - NTAP for Granite and TPT for outpatient procedures with zero device offset [26][27] - Proposed reimbursement increases for office-based lab procedures and outpatient settings [29][30] - **Impact of Regulatory Changes**: - Potential for increased outpatient procedures due to new APC codes [30] Strategic Outlook - **Growth Strategy**: - Focus on expanding product offerings and leveraging existing physician relationships [23][24] - Emphasis on maintaining differentiation and high gross margins while scaling operations [43][44] - **Market Positioning**: - Strong internal R&D capabilities and a commitment to addressing unmet needs in the market [42][44] Conclusion - **Future Prospects**: - Confidence in sustaining growth through new product launches and market expansion, with a strong focus on profitability and cash flow management [17][45]
SI-BONE(SIBN) - 2025 Q2 - Quarterly Report
2025-08-05 20:17
PART I - FINANCIAL INFORMATION [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) Presents unaudited condensed consolidated financial statements and detailed notes [Condensed Consolidated Balance Sheets (Unaudited)](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20%28Unaudited%29) Presents the company's financial position, detailing assets, liabilities, and equity | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------- | :----------------------------- | :------------------------------- | | Total Assets | $230,921 | $230,437 | | Total Liabilities | $60,578 | $63,473 | | Total Stockholders' Equity | $170,343 | $166,964 | [Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20%28Unaudited%29) Presents the company's financial performance, including revenue, expenses, and net loss | Metric (Three Months Ended June 30,) | 2025 (in thousands) | 2024 (in thousands) | Change ($) | Change (%) | | :----------------------------------- | :------------------ | :------------------ | :--------- | :--------- | | Revenue | $48,630 | $39,969 | $8,661 | 21.7% | | Net Loss | $(6,152) | $(8,939) | $2,787 | -31.2% | | Net Loss per Share | $(0.14) | $(0.22) | $0.08 | -36.4% | | Gross Margin | 79.8% | 79.0% | 0.8% | 1.0% | [Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited)](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity%20%28Unaudited%29) Details changes in the company's equity, including stock-based compensation and accumulated deficit | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------- | :----------------------------- | :------------------------------- | | Total Stockholders' Equity | $170,343 | $166,964 | | Accumulated Deficit | $(444,048) | $(431,354) | | Metric (Six Months Ended June 30,) | 2025 (in thousands) | 2024 (in thousands) | | :--------------------------------- | :------------------ | :------------------ | | Stock-based compensation | $13,321 | $13,428 | [Condensed Consolidated Statements of Cash Flows (Unaudited)](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20%28Unaudited%29) Presents cash flows from operating, investing, and financing activities | Metric (Six Months Ended June 30,) | 2025 (in thousands) | 2024 (in thousands) | Change ($) | | :--------------------------------- | :------------------ | :------------------ | :--------- | | Net cash used in operating activities | $(4,738) | $(13,905) | $9,167 | | Net cash provided by investing activities | $1,159 | $4,517 | $(3,358) | | Net cash provided by financing activities | $2,336 | $1,881 | $455 | | Cash and cash equivalents at end of period | $34,150 | $25,577 | $8,573 | [Notes to Condensed Consolidated Financial Statements (Unaudited)](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) Provides detailed explanations and disclosures for condensed consolidated financial statements [1. The Company and Nature of Business](index=10&type=section&id=1.%20The%20Company%20and%20Nature%20of%20Business) Describes the company's medical device business, product lines, and regulatory clearances - SI-BONE, Inc. 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[27](index=27&type=chunk) - The Company has launched multiple implant product lines, including iFuse-3D (2017), iFuse TORQ (2021), iFuse Bedrock Granite (2022), and iFuse INTRA and iFuse TORQ TNT (2024)[27](index=27&type=chunk) - Products have clearances for sacroiliac joint dysfunction, adult spinal deformity, and pelvic trauma in the United States, and sacroiliac fusion, adult spinal deformity, and pelvic fracture fixation in Europe[27](index=27&type=chunk) [2. Summary of Significant Accounting Policies](index=11&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) Outlines key accounting policies, U.S. GAAP compliance, and segment reporting - The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. GAAP and SEC rules for interim financial reporting, with certain footnotes condensed or omitted[29](index=29&type=chunk) - There have been **no material changes** to the Company's significant accounting policies as disclosed in the **2024 Annual Report**[32](index=32&type=chunk) - The Company operates as a single operating and reportable segment, with substantially all revenue derived from U.S. customers (international revenue less than **10%**)[33](index=33&type=chunk)[34](index=34&type=chunk) - The Company is evaluating the impacts of new accounting pronouncements: ASU 2023-09 (Income Taxes) effective after December 15, 2024, and ASU 2024-03 (Expense Disaggregation) effective after December 15, 2026[36](index=36&type=chunk)[37](index=37&type=chunk) [3. Marketable Securities](index=12&type=section&id=3.%20Marketable%20Securities) Details marketable securities classification, fair value, and unrealized gains/losses - All of the Company's marketable securities are classified as available-for-sale[38](index=38&type=chunk) | Marketable Securities | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------- | :--------------------------- | :------------------------------- | | Total Fair Value | $139,215 | $142,420 | - Unrealized losses are generally due to interest rate fluctuations, not credit quality, and are recorded in accumulated other comprehensive income (loss)[39](index=39&type=chunk) [4. Fair Value Measurement](index=13&type=section&id=4.%20Fair%20Value%20Measurement) Explains fair value measurements for financial instruments, including marketable securities - Carrying amounts of cash equivalents, accounts receivable, accounts payable, and accrued liabilities approximate fair value due to their short maturities[41](index=41&type=chunk) | Marketable Securities Fair Value | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :------------------------------- | :--------------------------- | :------------------------------- | | Level 1 | $135,175 | $140,064 | | Level 2 | $4,040 | $2,356 | | Total | $139,215 | $142,420 | [5. Balance Sheet Components](index=14&type=section&id=5.%20Balance%20Sheet%20Components) Provides details on key balance sheet items like inventory, property, and accrued liabilities | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :--------------------------- | :------------------------------- | | Inventory | $34,245 | $27,074 | | Property and Equipment, net | $21,701 | $20,374 | | Accrued Liabilities and Other | $16,149 | $19,492 | | Allowance for Credit Losses (end of period) | $911 | $588 | - **Inventory increased** primarily in finished goods. **Accrued liabilities decreased** mainly due to lower accrued compensation[43](index=43&type=chunk)[45](index=45&type=chunk) [6. Commitments and Contingencies](index=15&type=section&id=6.%20Commitments%20and%20Contingencies) Discloses lease commitments, purchase commitments, and legal contingencies - The Company extended its Santa Clara office lease to July 31, 2026. **Total operating lease liabilities** as of June 30, 2025, are **$1,424 thousand**[47](index=47&type=chunk)[49](index=49&type=chunk) | Commitment Type | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :---------------- | :--------------------------- | :------------------------------- | | Purchase Commitments | $1,900 | $400 | - The Company received a Civil Investigative Demand from the U.S. Department of Justice in October 2024 related to an investigation under the federal Anti-Kickback Statute and Civil False Claims Act[55](index=55&type=chunk) [7. Borrowings](index=16&type=section&id=7.%20Borrowings) Details the company's term loan, principal outstanding, and effective interest rates | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--------------------------------------- | :--------------------------- | :------------------------------- | | Principal outstanding (Term Loan) | $36,000 | $36,000 | | Outstanding debt, net of issuance costs | $35,510 | $35,452 | - The Company entered into a Third Amendment to Loan and Security Agreement with First-Citizens in November 2024, refinancing the existing term loan for **$36.0 million**, with a maturity date of September 1, 2029[61](index=61&type=chunk) | Metric (Effective Interest Rate) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :------------------------------- | :------------------------------- | :------------------------------- | | Effective Interest Rate | 7.3% | 9.3% | - The Company was in compliance with all debt covenants as of June 30, 2025[63](index=63&type=chunk) [8. Stock-Based Incentive Compensation Plans](index=18&type=section&id=8.%20Stock-Based%20Incentive%20Compensation%20Plans) Outlines stock options, RSUs, PSUs, and related stock-based compensation expense | Stock Options | June 30, 2025 | | :---------------------------- | :------------ | | Outstanding Shares | 913,617 | | Weighted Average Exercise Price | $11.40 | | Aggregate Intrinsic Value | $7,689 | | Restricted Stock Units (RSUs) and Performance Stock Units (PSUs) | June 30, 2025 | December 31, 2024 | | :------------------------------------------------- | :------------ | :---------------- | | RSUs Outstanding | 2,514,767 | 1,884,640 | | PSUs Outstanding | 785,457 | 610,541 | | Stock-Based Compensation Expense (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total | $6,658 | $6,398 | $13,321 | $13,428 | [9. Net Loss Per Share of Common Stock](index=20&type=section&id=9.%20Net%20Loss%20Per%20Share%20of%20Common%20Stock) Presents net loss per share calculations and anti-dilutive securities | Metric (Net Loss Per Share, Basic and Diluted) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net Loss Per Share | $(0.14) | $(0.22) | $(0.30) | $(0.48) | - Outstanding stock options, restricted stock units, ESPP purchase rights, and common stock warrants were anti-dilutive and excluded from diluted net loss per share computation due to net losses in all periods presented[73](index=73&type=chunk)[74](index=74&type=chunk) [10. Income Taxes](index=21&type=section&id=10.%20Income%20Taxes) Discusses income tax provisions, valuation allowances, and impacts of new tax legislation - The Company did not have a provision for income taxes for the three and six months ended June 30, 2025 and 2024[75](index=75&type=chunk) - A full valuation allowance is maintained against net deferred tax assets due to uncertainty surrounding their realization[75](index=75&type=chunk) - The Company is assessing the impact of the 'One Big Beautiful Bill Act' (OBBBA), signed July 4, 2025, on its financial statements[77](index=77&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management's perspective on financial performance, condition, and future outlook [Overview](index=22&type=section&id=Overview) Provides a high-level overview of the company's medical device business and product portfolio - SI-BONE is a medical device company focused on proprietary minimally invasive surgical implant systems for sacroiliac joint dysfunction and pelvic fixation[79](index=79&type=chunk) - The product portfolio includes iFuse, iFuse-3D, iFuse TORQ, iFuse Bedrock Granite, iFuse INTRA, and iFuse TORQ TNT, with various regulatory clearances[80](index=80&type=chunk) - Over **127,000 procedures** have been performed using the Company's products by over **4,600 physicians** in the United States and **38 other countries** since 2009[81](index=81&type=chunk) [Factors Affecting Results of Operations and Key Performance Indicators](index=22&type=section&id=Factors%20Affecting%20Results%20of%20Operations%20and%20Key%20Performance%20Indicators) Outlines key drivers and metrics influencing financial performance and strategic initiatives [Expand Access to Solutions](index=22&type=section&id=Expand%20Access%20to%20Solutions) Focuses on increasing sales force capacity, productivity, and market penetration - The Company is focused on increasing sales managers' capacity and driving sales force productivity by adding clinical support specialists, implementing hybrid models, and placing instrument trays and implants at select sites[84](index=84&type=chunk) | Sales Force Component | June 30, 2025 | June 30, 2024 | | :-------------------- | :------------ | :------------ | | U.S. Territory Sales Managers | 85 | 85 | | U.S. Clinical Support Specialists | 75 | 67 | | U.S. Third-Party Sales Agents | 295 | 204 | | International Sales Representatives | 10 | 11 | | International Third-Party Sales Agents and Resellers | 29 | 29 | - Over **30%** of sacroiliac joint dysfunction procedures for the quarter ended June 30, 2025, were performed at ambulatory surgery centers (ASCs) or Office-Based Labs (OBLs)[86](index=86&type=chunk) [Physician Engagement](index=23&type=section&id=Physician%20Engagement) Describes strategies for educating physicians and growing product adoption through training - The Company engages and educates physicians and healthcare professionals on the clinical merits and patient benefits of its solutions to grow physician adoption[87](index=87&type=chunk) - Training methods include hands-on cadaveric and dry-lab training, as well as the SI-BONE SImulator[88](index=88&type=chunk) | Physician Training | June 30, 2025 | June 30, 2024 | | :----------------- | :------------ | :------------ | | U.S. Physicians Trained | >3,600 | >2,900 | | International Physicians Trained | >1,100 | >1,000 | | Surgical Residents and Fellows Trained (since Aug 2018) | ~2,000 | N/A | [Expand Addressable Markets](index=24&type=section&id=Expand%20Addressable%20Markets) Details efforts to expand sacropelvic solutions and clinical trial results for new products - The Company is expanding its platform of sacropelvic solutions to address sacroiliac joint dysfunction, pelvic fixation, and pelvic trauma with a comprehensive product portfolio[91](index=91&type=chunk) - Clinical trial results: SILVIA study showed iFuse-3D **reduced** new-onset SI joint pain; SAFFRON study showed **higher** mobility recovery with iFuse TORQ for sacral fragility fractures; STACI study showed **low** adverse event rate and early pain/function improvement with iFuse TORQ[92](index=92&type=chunk)[93](index=93&type=chunk)[94](index=94&type=chunk) | Research and Development Expenses (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------------------- | :----------------------------- | :----------------------------- | | R&D Expense | $8,843 | $8,697 | | R&D as % of Revenue | 9% | 11% | [Enhance Employee Experience and Engagement](index=25&type=section&id=Enhance%20Employee%20Experience%20and%20Engagement) Focuses on talent recruitment, development, retention, and workplace culture - The Company focuses on recruiting, developing, and retaining highly skilled talent through a diverse and inclusive workplace, competitive compensation, and health and wellness programs[96](index=96&type=chunk) - Strategies include establishing feedback mechanisms, enhancing people manager skills, improving internal communications, and providing ongoing learning and leadership training opportunities[97](index=97&type=chunk)[98](index=98&type=chunk) [Gain Operational Efficiency](index=25&type=section&id=Gain%20Operational%20Efficiency) Aims to improve business processes, sales force productivity, and asset utilization - The Company is evolving business processes to identify, measure, and improve operational efficiency, **increase** sales force productivity, and improve asset utilization[99](index=99&type=chunk) | Metric | June 30, 2025 | June 30, 2024 | | :-------------------------------- | :------------ | :------------ | | Trailing Twelve Month Average Revenue per Territory Sales Manager | ~$2.1 million | ~$1.7 million | - Initiatives include working with suppliers to reduce lead times for implants, optimizing product design for manufacturing, and integrating demand planning and manufacturing systems[101](index=101&type=chunk) [Components of Results of Operations](index=25&type=section&id=Components%20of%20Results%20of%20Operations) Defines key financial components constituting the company's results of operations [Revenue](index=25&type=section&id=Revenue) Describes factors influencing implant sales revenue and seasonal variations - **Revenue** from implant sales fluctuates based on case volume, discounts, U.S./international sales mix, implant pricing, and the number of implants used per patient[102](index=102&type=chunk) - The business is affected by seasonal variations, with lower sales in summer and higher sales in the last quarter of the fiscal year, though seasonality does not materially impact annual financial results[103](index=103&type=chunk) [Cost of Goods Sold, Gross Profit, and Gross Margin](index=26&type=section&id=Cost%20of%20Goods%20Sold%2C%20Gross%20Profit%2C%20and%20Gross%20Margin) Defines cost of goods sold components and their impact on gross profit and margin - Cost of goods sold primarily includes costs of implant components, instruments, instrument tray depreciation, royalties, scrap, inventory obsolescence, and distribution expenses[104](index=104&type=chunk) - Cost of goods sold historically **increases** with case levels and changes in product mix[104](index=104&type=chunk) [Operating Expenses](index=26&type=section&id=Operating%20Expenses) Outlines operating expense categories, including sales, marketing, R&D, and G&A - **Operating expenses** consist of sales and marketing, research and development, and general and administrative expenses, with personnel costs being the most significant component[105](index=105&type=chunk) - The Company anticipates certain **operating expenses** will continue to **increase** to support growth and strategic plans[105](index=105&type=chunk) [Interest Income](index=26&type=section&id=Interest%20Income) Explains interest income sources from cash and marketable securities investments - **Interest income** is primarily related to investments of excess cash in money market funds and marketable securities[110](index=110&type=chunk) [Interest Expense](index=26&type=section&id=Interest%20Expense) Details interest expense components related to borrowings and debt issuance costs - **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[111](index=111&type=chunk) [Other Income (Expense), Net](index=26&type=section&id=Other%20Income%20%28Expense%29%2C%20Net) Covers net foreign exchange gains and losses on international transactions - Other income (expense), net primarily consists of net foreign exchange gains and losses on foreign transactions[112](index=112&type=chunk) [Results of Operations](index=27&type=section&id=Results%20of%20Operations) Detailed comparative analysis of financial performance for reported periods [Comparison of the Three Months Ended June 30, 2025 and 2024](index=27&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030%2C%202025%20and%202024) Compares financial performance for the three months ended June 30, 2025 and 2024 | Metric (Three Months Ended June 30,) | 2025 (in thousands) | 2024 (in thousands) | Change ($) | Change (%) | | :----------------------------------- | :------------------ | :------------------ | :--------- | :--------- | | Revenue | $48,630 | $39,969 | $8,661 | 21.7% | | Gross Profit | $38,807 | $31,576 | $7,231 | 22.9% | | Gross Margin | 79.8% | 79.0% | 0.8% | 1.0% | | Total Operating Expenses | $45,811 | $41,654 | $4,157 | 10.0% | | Interest Income | $1,520 | $2,015 | $(495) | -24.6% | | Interest Expense | $(666) | $(880) | $214 | -24.3% | - **Revenue increase** was primarily driven by a **$8.6 million increase** in U.S. revenue from **increased** case volumes due to an expanded product portfolio[113](index=113&type=chunk) - **Operating expenses increased** due to a **$2.5 million increase** in sales and marketing commissions/personnel costs and a **$1.4 million increase** in general and administrative personnel costs/stock-based compensation, along with a **$0.9 million increase** in legal and consulting fees[115](index=115&type=chunk)[117](index=117&type=chunk) [Comparison of the Six Months Ended June 30, 2025 and 2024](index=29&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) Compares financial performance for the six months ended June 30, 2025 and 2024 | Metric (Six Months Ended June 30,) | 2025 (in thousands) | 2024 (in thousands) | Change ($) | Change (%) | | :--------------------------------- | :------------------ | :------------------ | :--------- | :--------- | | Revenue | $95,920 | $77,836 | $18,084 | 23.2% | | Gross Profit | $76,502 | $61,441 | $15,061 | 24.5% | | Gross Margin | 79.8% | 78.9% | 0.9% | 1.1% | | Total Operating Expenses | $90,986 | $83,562 | $7,424 | 8.9% | | Interest Income | $3,112 | $4,128 | $(1,016) | -24.6% | | Interest Expense | $(1,328) | $(1,761) | $433 | -24.6% | - **Revenue increase** was primarily driven by a **$18.0 million increase** in U.S. revenue due to **increased** case volumes from an expanded product portfolio[121](index=121&type=chunk) - **Operating expenses increased** due to a **$4.2 million increase** in sales and marketing commissions/personnel costs and a **$2.5 million increase** in general and administrative personnel costs/stock-based compensation, along with a **$1.7 million increase** in legal, consulting, and bad debt expense[124](index=124&type=chunk)[126](index=126&type=chunk) [Liquidity and Capital Resources](index=30&type=section&id=Liquidity%20and%20Capital%20Resources) Discusses financial position, debt, cash flow, and ability to fund future operations | Metric | June 30, 2025 (in millions) | December 31, 2024 (in millions) | | :-------------------------- | :-------------------------- | :------------------------------ | | Cash and Marketable Securities | $145.5 | $150.0 | | Outstanding Debt | $35.5 | $35.5 | | Accumulated Deficit | $(444.0) | $(431.4) | - The Company expects existing cash and marketable securities to fund operating expenses and capital expenditure requirements over the next **12 months**[131](index=131&type=chunk) [Term Loan](index=31&type=section&id=Term%20Loan) Details outstanding debt, refinancing terms, maturity, and future principal payments - The Company's **outstanding debt** is related to a Third Amended Loan Agreement with First-Citizens, which refinanced the existing term loan for **$36.0 million** in November 2024, maturing on September 1, 2029[135](index=135&type=chunk) | Future Principal Payments (in thousands) | | :--------------------------------------- | | 2027: $6,000 | | 2028: $18,000 | | 2029: $12,000 | | Total: $36,000 | | Contractual Obligations | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :---------------------- | :--------------------------- | :------------------------------- | | Total | $47,600 | $48,100 | [Cash Flows](index=32&type=section&id=Cash%20Flows) Analyzes cash flow activities from operations, investing, and financing | Cash Flow Activity (Six Months Ended June 30,) | 2025 (in thousands) | 2024 (in thousands) | Change ($) | | :--------------------------------------------- | :------------------ | :------------------ | :--------- | | Net cash used in operating activities | $(4,738) | $(13,905) | $9,167 | | Net cash provided by investing activities | $1,159 | $4,517 | $(3,358) | | Net cash provided by financing activities | $2,336 | $1,881 | $455 | - The **decrease in net cash used in operating activities** was mainly due to **decreased net loss**, net of non-cash items, and improved collections, partially offset by higher inventory build-up and lower accrued liabilities[141](index=141&type=chunk) [Critical Accounting Policies, Significant Judgments, and Use of Estimates](index=33&type=section&id=Critical%20Accounting%20Policies%2C%20Significant%20Judgments%2C%20and%20Use%20of%20Estimates) Highlights critical accounting policies and significant management estimates - The preparation of financial statements requires management to make estimates and assumptions that affect reported amounts[144](index=144&type=chunk) - There have been **no material changes** to the descriptions of critical accounting policies, judgments, and estimates since the **2024 Annual Report**[145](index=145&type=chunk) [Seasonality](index=33&type=section&id=Seasonality) Discusses historical seasonal sales patterns and their impact on financial results - The Company historically experiences lower sales in the summer months and higher sales in the last quarter of the fiscal year[146](index=146&type=chunk) - Seasonality does not have a material impact on the Company's financial results from year to year[146](index=146&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Describes exposure to market risks, specifically foreign currency and interest rate risk [Foreign Currency Exchange Risk](index=33&type=section&id=Foreign%20Currency%20Exchange%20Risk) Assesses exposure to foreign currency fluctuations and their potential impact - The Company has foreign currency risks related to revenue and operating expenses denominated in currencies other than the U.S. dollar, primarily the Euro[148](index=148&type=chunk) - Changes in exchange rates, particularly a strengthening U.S. dollar, may negatively affect revenue and operating results[148](index=148&type=chunk) - Foreign currency gains or losses were not material, and a hypothetical **100 basis point change** in exchange rates would not have a material impact[149](index=149&type=chunk) [Interest Rate Risk](index=33&type=section&id=Interest%20Rate%20Risk) Evaluates exposure to interest rate changes on investments and floating-rate debt - Exposure to interest rate changes relates to interest earned on cash/investments and interest paid on the floating-rate Third Amendment Term Loan[150](index=150&type=chunk)[151](index=151&type=chunk) - The Company's investment policy focuses on capital preservation and liquidity, not trading or speculative purposes[150](index=150&type=chunk) - A hypothetical **100 basis point change** in market interest rates would not have a material impact due to the low-risk profile of investments and the amount of the term loan[151](index=151&type=chunk) [Item 4. Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) Details disclosure controls and procedures, including effectiveness and internal control changes [Evaluation of Disclosure Controls and Procedures](index=34&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) Describes the design and effectiveness of disclosure controls and procedures - Disclosure controls and procedures are designed to ensure information required for SEC reports is recorded, processed, summarized, and reported timely[152](index=152&type=chunk) - The CEO and CFO concluded that, as of June 30, 2025, the Company's disclosure controls and procedures were **effective** at the reasonable assurance level[154](index=154&type=chunk) [Changes in internal control over financial reporting](index=34&type=section&id=Changes%20in%20internal%20control%20over%20financial%20reporting) Reports on any material changes in internal controls over financial reporting - During the quarter ended June 30, 2025, there were **no material changes** in the Company's internal controls over financial reporting[155](index=155&type=chunk) PART II - OTHER INFORMATION [Item 1. Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) Discloses legal proceedings, noting no material adverse effects except for a disclosed investigation - The Company is involved in various claims, complaints, investigations, and legal actions arising in the normal course of business[156](index=156&type=chunk) - Except for the Investigation mentioned in Note 6, **no material legal proceedings** are pending that would have a material adverse effect on the Company[156](index=156&type=chunk) [Item 1A. Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) Updates significant risks, including supply chain, manufacturing, and stock price volatility - **No material changes** from the risk factors previously disclosed in the **2024 Annual Report**, but additional risks and uncertainties may exist[157](index=157&type=chunk) - Disruptions in the supply of materials and components (e.g., titanium) or sterilization services by third-party suppliers could adversely affect the business[158](index=158&type=chunk)[159](index=159&type=chunk) - Various factors outside direct control, such as sterilization failures, transportation risks, supply chain disruptions (including inflation), and natural disasters, may adversely affect manufacturing and distribution[160](index=160&type=chunk)[162](index=162&type=chunk) - The price of common stock may be volatile due to macroeconomic factors, company performance, industry trends, and potential securities litigation[161](index=161&type=chunk)[163](index=163&type=chunk) - Inadequate funding for the FDA and other government agencies, or disruptions to their workforces, could hinder product development and commercialization[164](index=164&type=chunk)[166](index=166&type=chunk) - Uncertainty in the coverage and reimbursement environment for sacroiliac joint fusion procedures (CPT Codes 27279 and 27278) may **decrease** demand for products and negatively impact the business[168](index=168&type=chunk)[170](index=170&type=chunk)[171](index=171&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=37&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) States no unregistered sales of equity securities or use of proceeds to report - **None**[172](index=172&type=chunk) [Item 3. Defaults Upon Senior Securities](index=37&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Indicates no defaults upon senior securities during the reported period - **None**[173](index=173&type=chunk) [Item 4. Mine Safety Disclosures](index=39&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) States that mine safety disclosures are not applicable to the company - **Not Applicable**[174](index=174&type=chunk) [Item 5. Other Information](index=39&type=section&id=Item%205.%20Other%20Information) Discloses Rule 10b5-1 trading arrangements by certain Section 16 officers and directors - Michael Pisetsky (Chief Business & Legal Affairs Officer) adopted a Rule 10b5-1 trading arrangement on June 13, 2025, for up to **238,985 shares**[176](index=176&type=chunk) - Jeffrey W. Dunn (Chairman of the Board of Directors) adopted a Rule 10b5-1 trading arrangement on May 8, 2025, for up to **240,000 shares**[176](index=176&type=chunk) - **No other directors** or executive officers adopted Rule 10b5-1 trading arrangements during the three-month period ended June 30, 2025[177](index=177&type=chunk) [Item 6. Exhibits](index=40&type=section&id=Item%206.%20Exhibits) Lists all exhibits filed with the Form 10-Q, including corporate documents and certifications - Exhibits include Amended and Restated Certificate of Incorporation, Second Amended and Restated Bylaws, and various agreements[178](index=178&type=chunk) - Certifications of Principal Executive Officer and Principal Financial Officer (**31.1***, **31.2***, **32.1***) are filed or furnished[178](index=178&type=chunk)[179](index=179&type=chunk) - Inline XBRL Instance Document and Taxonomy Extension Documents are included[178](index=178&type=chunk) [SIGNATURES](index=41&type=section&id=SIGNATURES) Contains official signatures of CEO and CFO certifying the Form 10-Q filing - The Report was signed by Laura A. Francis (Chief Executive Officer) and Anshul Maheshwari (Chief Financial Officer) on August 5, 2025[184](index=184&type=chunk)[185](index=185&type=chunk)
Si-Bone (SIBN) Reports Q2 Loss, Beats Revenue Estimates
ZACKS· 2025-08-04 22:47
Financial Performance - Si-Bone reported a quarterly loss of $0.14 per share, better than the Zacks Consensus Estimate of a loss of $0.19, and an improvement from a loss of $0.22 per share a year ago, representing an earnings surprise of +26.32% [1] - The company posted revenues of $48.63 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 0.80%, and showing an increase from $39.97 million in the same quarter last year [2] - Over the last four quarters, Si-Bone has exceeded consensus EPS estimates four times and topped consensus revenue estimates three times [2] Stock Performance - Si-Bone shares have increased approximately 24% since the beginning of the year, significantly outperforming the S&P 500's gain of 6.1% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.17 on revenues of $46.68 million, and for the current fiscal year, it is -$0.62 on revenues of $196.13 million [7] Industry Outlook - The Medical - Instruments industry, to which Si-Bone belongs, is currently ranked in the bottom 37% of over 250 Zacks industries, indicating potential challenges ahead [8] - The performance of Si-Bone's stock may be influenced by the overall outlook for the industry, as research indicates that the top 50% of Zacks-ranked industries outperform the bottom 50% by more than 2 to 1 [8]