Part I [Business](index=8&type=section&id=Item%201.%20Business) SI-BONE specializes in proprietary minimally invasive surgical implant systems for sacropelvic disorders, marketed globally [Overview](index=8&type=section&id=Overview) **SI-BONE** focuses on minimally invasive surgical implant systems for sacropelvic disorders, with over **75,000 procedures** performed by year-end **2022** - The company specializes in minimally invasive surgical implant systems for sacropelvic anatomy, with key product lines including **iFuse**, **iFuse-3D**, **iFuse-TORQ**, and **iFuse Bedrock Granite**[20](index=20&type=chunk) - As of year-end **2022**, over **75,000 procedures** have been performed by more than **3,000 surgeons** across the U.S. and **38 other countries** since the first **iFuse** launch in **2009**[21](index=21&type=chunk) [Product and Applications](index=8&type=section&id=Product%20and%20Applications) The company's **iFuse** product line has evolved to include **3D-printed** and threaded implants, with the **Bedrock Granite** receiving **FDA Breakthrough Device Designation** and **NTAP** - The **iFuse** product line includes the original machined titanium implant (**2009**), the **iFuse-3D** with a proprietary **3D-printed** porous surface (**2017**), and the **iFuse-TORQ** threaded implant for trauma and **SI** joint applications (**2021**)[22](index=22&type=chunk)[24](index=24&type=chunk) - The **iFuse Bedrock Granite** implant, launched in May **2022**, is designed for sacroiliac fusion and sacropelvic fixation. It received **FDA Breakthrough Device Designation** and a **CMS New Technology Add-on Payment (NTAP)** effective October **1, 2022**[25](index=25&type=chunk) - The company also provides enabling technologies compatible with **Medtronic's** surgical navigation and **Mazor** robotic systems[26](index=26&type=chunk) [Market Opportunity](index=10&type=section&id=Market%20Opportunity) **SI-BONE** estimates its total U.S. addressable market at approximately **$3.0 billion**, segmented across sacroiliac joint dysfunction, adult deformity, and pelvic trauma U.S. Total Addressable Market Estimate | Market Segment | Estimated Annual Market Size | | :--- | :--- | | Sacroiliac Joint Dysfunction & Degeneration | ~$2.4 billion | | Adult Deformity & Degeneration | ~$250 million | | Pelvic Trauma | ~$350 million | | **Total** | **~$3.0 billion** | [Clinical Evidence](index=10&type=section&id=Clinical%20Evidence) The company's **iFuse** implants are supported by over **100 publications** and multiple clinical trials demonstrating safety, effectiveness, and economic utility - The company's products are supported by over **100 publications**, including two randomized controlled trials (**INSITE** and **iMIA**) and long-term follow-up studies (**LOIS**) showing sustained improvements in pain, disability, and quality of life for up to **five years**[32](index=32&type=chunk)[33](index=33&type=chunk)[34](index=34&type=chunk)[36](index=36&type=chunk) - The **SILVIA** trial, a randomized study of **iFuse-3D** in multilevel spine fusion, completed enrollment in **2022** with long-term results expected in **2024**[38](index=38&type=chunk) - The **SAFFRON** trial, a randomized study comparing **iFuse-TORQ** to non-surgical management for sacral fragility fractures, is currently enrolling with results anticipated in late **2024**[39](index=39&type=chunk) [Coverage and Reimbursement](index=13&type=section&id=Coverage%20and%20Reimbursement) Substantially all U.S. payors reimburse for sacroiliac joint fusion, with many providing exclusive positive coverage for **SI-BONE's** patented triangular implants - A significant number of U.S. payors provide exclusive positive coverage for **SI-BONE's** patented triangular titanium implants for sacroiliac joint fusion, based on the company's clinical evidence[43](index=43&type=chunk) [Healthcare Professional Training and Education](index=14&type=section&id=Healthcare%20Professional%20Training%20and%20Education) **SI-BONE** invests in educating healthcare professionals using a portable simulator, training over **2,200 U.S. surgeons** and **800 international surgeons** by year-end **2022** - The company utilizes **25 portable**, computer-based **SI-BONE SImulators** worldwide for surgeon training on **SI** joint fusion and **Bedrock** techniques without needing an operating room[47](index=47&type=chunk) Number of Trained Surgeons (Cumulative) | Region | Dec 31, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | U.S. | >2,200 | >1,800 | | International | >800 | >700 | [Sales and Marketing](index=15&type=section&id=Sales%20and%20Marketing) The company primarily uses a direct sales force in the U.S. and a mix of direct sales and distributors internationally, complemented by digital marketing efforts Sales Force Composition (as of Dec 31, 2022) | Region | Direct Employees (Managers & Specialists) | Third-Party Distributors | | :--- | :--- | :--- | | U.S. | 161 (88 managers, 73 specialists) | 105 | | International | 18 | 30 | [Competition](index=15&type=section&id=Competition) **SI-BONE** faces competition from larger medical device companies but differentiates itself through its unique implant design and extensive clinical evidence - Primary competitors in the U.S. are **Globus Medical, Inc.** and **Medtronic plc**. In Europe, they are **Globus Medical** and **SIGNUS Medizintechnik GmbH**[54](index=54&type=chunk) - The company differentiates itself through its triangular titanium implant design and extensive clinical evidence, including over **100 published papers**, which has resulted in exclusive reimbursement coverage from certain U.S. payors[55](index=55&type=chunk) [Intellectual Property](index=16&type=section&id=Intellectual%20Property) As of year-end **2022**, the company held **51 U.S.** and **16 foreign patents**, with key original **iFuse** patents expiring in November **2024** and **iFuse-3D** patents in September **2035** - As of year-end **2022**, the company held **51 issued U.S. patents** and **16 issued foreign patents**, with **32 U.S.** and **18 foreign applications** pending[56](index=56&type=chunk) - Key U.S. patents on the original **iFuse** triangular shape expire in November **2024**, while patents on the **iFuse-3D** design expire in September **2035**[56](index=56&type=chunk) [Regulation](index=18&type=section&id=Regulation) The company's products are subject to extensive **FDA** and international regulations, including **510(k)** clearance, **QSR**, fraud and abuse laws, and data privacy compliance - The company's products are regulated by the **FDA**, primarily through the **510(k)** premarket notification process for **Class II devices**[62](index=62&type=chunk)[64](index=64&type=chunk)[66](index=66&type=chunk) - The **iFuse Bedrock Granite** implant received **FDA breakthrough device designation** in November **2021** and **510(k)** clearance in May **2022**, which facilitated obtaining a **New Technology Add-on Payment (NTAP)** from **CMS**[88](index=88&type=chunk) - Internationally, the company must comply with regulations such as the **EU's Medical Device Regulation (MDR)**, the **UK's UKCA mark** requirements, and Swiss medical device ordinances[80](index=80&type=chunk)[91](index=91&type=chunk)[92](index=92&type=chunk) - The company is subject to federal and state fraud and abuse laws, including the **Anti-Kickback Statute** and the **Physician Payment Sunshine Act**, as well as data privacy laws like **HIPAA** in the U.S. and **GDPR** in the **EU**[95](index=95&type=chunk)[96](index=96&type=chunk)[100](index=100&type=chunk)[103](index=103&type=chunk) [Manufacturing and Supply](index=30&type=section&id=Manufacturing%20and%20Supply) **SI-BONE** outsources all manufacturing to third parties, primarily **rms Company (RMS)** as a sole source for key implants, requiring compliance with **FDA QSR** and **ISO 13485:2016** standards - The company relies on third-party manufacturers for all its products, with **rms Company (RMS)** being the primary and sole supplier for **iFuse-3D** and **iFuse-TORQ** implants[107](index=107&type=chunk)[108](index=108&type=chunk) - Manufacturing facilities are subject to **FDA's Quality System Regulation (QSR)** and international standards, and the company holds **ISO 13485:2016** certification for its Santa Clara and Gallarate locations[110](index=110&type=chunk)[111](index=111&type=chunk) [Human Capital Resources](index=30&type=section&id=Human%20Capital%20Resources) As of December **31, 2022**, the company had **357 employees**, emphasizing diversity, competitive compensation, and career development programs to manage attrition - As of December **31, 2022**, the company had **357 employees**, with a direct field sales organization of **161** in the U.S. and **18** in Europe[116](index=116&type=chunk) - The voluntary employee attrition rate was approximately **11%** in **2022**[116](index=116&type=chunk) - The company promotes diversity, with **four of nine board members** being women and two identifying as Asian American. It implemented a new career development program in **2022** to enhance employee retention[118](index=118&type=chunk)[124](index=124&type=chunk) [Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including a history of operating losses, reliance on the **iFuse** product family, supply chain disruptions, and extensive regulatory and intellectual property challenges - The company has a history of significant operating losses (**$61.3M** in **2022**) and may not achieve or sustain profitability[132](index=132&type=chunk) - Business is highly dependent on revenue from the **iFuse** family of products, making it vulnerable to market shifts or issues with this single product line[164](index=164&type=chunk) - Risks include dependence on third-party payor coverage and reimbursement, which can be uncertain and subject to change, and pricing pressure from competitors and ambulatory surgical centers (**ASCs**)[137](index=137&type=chunk)[154](index=154&type=chunk)[157](index=157&type=chunk) - The company faces extensive governmental regulation (**FDA**, international bodies), and failure to comply with complex rules, including fraud and abuse laws, could result in severe penalties[211](index=211&type=chunk)[223](index=223&type=chunk) - Key patents for the original **iFuse** triangular shape expire in November **2024**, which may allow competitors to market similar devices[272](index=272&type=chunk) [Properties](index=69&type=section&id=Item%202.%20Properties) The company's headquarters and additional R&D/warehouse space are leased in Santa Clara, California, with smaller offices supporting European operations - The company leases its headquarters in Santa Clara, CA (approx. **21,848 sq. ft.**, lease expires May **2025**) and has additional leased facilities in California, Italy, Germany, and the **UK**[297](index=297&type=chunk) [Legal Proceedings](index=69&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings that would have a significant adverse effect on its operations - The company is not currently involved in any material legal proceedings[298](index=298&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=70&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on **Nasdaq Global Market** under '**SIBN**', with no cash dividends ever paid or planned for the foreseeable future - Common stock is listed on the **Nasdaq Global Market** under the symbol "**SIBN**"[302](index=302&type=chunk) - The company has never declared or paid cash dividends and does not plan to in the foreseeable future[304](index=304&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=71&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) In **2022**, revenue grew **18%** to **$106.4 million**, but net loss widened to **$61.3 million** due to increased operating expenses, though liquidity is deemed sufficient for the next **12 months** [Impact of COVID-19 Pandemic](index=71&type=section&id=Impact%20of%20COVID-19%20Pandemic) The **COVID-19** pandemic continues to negatively impact revenues through case deferrals and disrupt the global supply chain for instruments and implants - The **COVID-19** pandemic has negatively impacted revenues through case deferrals and has caused disruptions in the global supply chain, leading to delays, product shortages, and rising costs for instruments and implants[312](index=312&type=chunk)[314](index=314&type=chunk) [Factors Affecting Results of Operations and Key Performance Indicators](index=72&type=section&id=Factors%20Affecting%20Results%20of%20Operations%20and%20Key%20Performance%20Indicators) Performance is driven by expanding solutions access, increasing surgeon penetration, and new product launches, supported by sales force growth and R&D investment - The U.S. sales force grew to **88 territory managers** and **73 clinical support specialists** by the end of **2022**, up from **85** and **65** respectively at the end of **2021**[319](index=319&type=chunk) - Average revenue per U.S. territory manager increased to approximately **$1.21 million** in **FY2022**, up from **$1.06 million** in **FY2021**[332](index=332&type=chunk) - The number of U.S. surgeons trained on **iFuse** grew from over **1,800** at **YE 2021** to over **2,200** at **YE 2022**[325](index=325&type=chunk) - R&D spending was **$13.6 million** in **2022**, representing **13%** of revenue, focused on new solutions and clinical trials like **SILVIA** and **SAFFRON**[328](index=328&type=chunk) [Results of Operations](index=77&type=section&id=Results%20of%20Operations) For **2022**, revenue increased **18%** to **$106.4 million**, but gross margin declined and operating expenses rose, leading to a wider net loss of **$61.3 million** Comparison of Operations (2022 vs 2021) | Metric | 2022 (in thousands) | 2021 (in thousands) | % Change | | :--- | :--- | :--- | :--- | | Revenue | $106,409 | $90,152 | 18% | | Gross Profit | $90,704 | $79,724 | 14% | | Gross Margin | 85% | 88% | -3 pts | | Total Operating Expenses | $150,313 | $131,394 | 14% | | Loss from Operations | ($59,609) | ($51,670) | 15% | | Net Loss | ($61,256) | ($56,572) | 8% | - The **$16.3 million** revenue increase was primarily driven by a **$16.0 million** rise in U.S. revenue due to higher case volumes from an expanding sales force and surgeon base[349](index=349&type=chunk) - Sales and marketing expenses increased by **$13.8 million (15%)** mainly due to higher employee-related costs and commissions from increased headcount and revenue[351](index=351&type=chunk) [Liquidity and Capital Resources](index=79&type=section&id=Liquidity%20and%20Capital%20Resources) As of December **31, 2022**, the company had **$97.3 million** in cash and marketable securities, with a net loss of **$61.3 million**, and refinanced its term loan in January **2023** Cash and Debt Position (Year-End) | Metric | Dec 31, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | Cash and Marketable Securities | $97.3 million | $147.0 million | | Outstanding Debt | $35.2 million | $35.0 million | | Accumulated Deficit | ($357.1 million) | ($295.8 million) | Cash Flow Summary | Cash Flow Activity | 2022 (in thousands) | 2021 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | ($41,655) | ($39,533) | | Net cash (used in) provided by investing activities | ($2,815) | $51,580 | | Net cash provided by (used in) financing activities | $2,197 | ($1,711) | - In January **2023**, the company refinanced its debt, repaying a **$35.0 million SVB** term loan and entering into a new agreement with **SVB** for a **$36.0 million** term loan and a **$15.0 million** revolving credit facility[364](index=364&type=chunk)[537](index=537&type=chunk) [Critical Accounting Policies, Significant Judgments, and Use of Estimates](index=83&type=section&id=Critical%20Accounting%20Policies%2C%20Significant%20Judgments%2C%20and%20Use%20of%20Estimates) Critical accounting policies involve significant judgments in revenue recognition upon procedure completion and valuing stock-based compensation using **Monte-Carlo** simulations - Revenue is primarily recognized upon completion of a surgical procedure and customer authorization, as this is when control of the product is transferred[374](index=374&type=chunk)[375](index=375&type=chunk) - The fair value of performance-based restricted stock units with market conditions is estimated using a **Monte-Carlo** simulation, a key area of management judgment[376](index=376&type=chunk) [Financial Statements and Supplementary Data](index=85&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) The consolidated financial statements, audited by **PricewaterhouseCoopers LLP** with an unqualified opinion, detail the company's financial position and results, highlighting revenue recognition as a critical audit matter [Report of Independent Registered Public Accounting Firm](index=86&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) **PricewaterhouseCoopers LLP** issued an unqualified opinion on the financial statements, identifying U.S. implantation product sales revenue recognition as a critical audit matter - The auditor, **PricewaterhouseCoopers LLP**, issued an unqualified (clean) opinion on the company's consolidated financial statements[384](index=384&type=chunk) - The auditor identified Revenue Recognition for U.S. implantation product sales as a **Critical Audit Matter**, citing the high degree of auditor effort involved in testing these transactions[389](index=389&type=chunk)[390](index=390&type=chunk) [Consolidated Financial Statements](index=88&type=section&id=Consolidated%20Financial%20Statements) The financial statements show total assets of **$157.6 million** and a net loss of **$61.3 million** for **2022**, with stockholders' equity decreasing to **$98.3 million** Consolidated Balance Sheet Data (in thousands) | Account | Dec 31, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash, cash equivalents & short-term investments | $97,290 | $146,979 | | Accounts receivable, net | $20,674 | $14,246 | | Inventory | $17,282 | $11,498 | | **Total Assets** | **$157,552** | **$190,506** | | **Liabilities & Equity** | | | | Total current liabilities | $21,178 | $16,890 | | Long-term borrowings | $35,171 | $34,973 | | **Total Liabilities** | **$59,250** | **$56,086** | | **Total Stockholders' Equity** | **$98,302** | **$134,420** | Consolidated Statement of Operations Data (in thousands) | Account | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | | :--- | :--- | :--- | | Revenue | $106,409 | $90,152 | | Gross Profit | $90,704 | $79,724 | | Loss from Operations | ($59,609) | ($51,670) | | Net Loss | ($61,256) | ($56,572) | | Net Loss Per Share | ($1.79) | ($1.71) | [Notes to Consolidated Financial Statements](index=92&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) Notes detail revenue recognition, debt agreements including a January **2023** refinancing, significant **NOL** carryforwards with a full valuation allowance, and a related party joint development agreement - The majority of revenue is recognized upon completion of the surgical procedure and customer authorization, net of any rebates or discounts[434](index=434&type=chunk) - As of Dec **31, 2022**, the company had a **$35.0 million** term loan with **SVB**, which was refinanced in January **2023**. The loan is secured by substantially all company assets except intellectual property[483](index=483&type=chunk) - As of Dec **31, 2022**, the company had federal and state **Net Operating Loss (NOL)** carryforwards of **$298.6 million** and **$238.7 million**, respectively. A full valuation allowance is maintained against these deferred tax assets[521](index=521&type=chunk) - The company has a joint development agreement with **SeaSpine**, a related party, for a next-generation device, involving reimbursement payments and future royalties[533](index=533&type=chunk)[534](index=534&type=chunk)[535](index=535&type=chunk) [Controls and Procedures](index=118&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of December **31, 2022**, with no auditor attestation required as a smaller reporting company - Management concluded that as of December **31, 2022**, the company's disclosure controls and procedures were effective at the reasonable assurance level[545](index=545&type=chunk) - Management concluded that internal control over financial reporting was effective as of December **31, 2022**. An auditor's attestation report was not included as the company is exempt as a "smaller reporting company"[546](index=546&type=chunk) Part III [Directors, Executive Compensation, Security Ownership, and Principal Accountant Fees](index=119&type=section&id=Item%2010%2C%2011%2C%2012%2C%2013%2C%2014) This section incorporates information on directors, executive compensation, security ownership, and principal accountant fees by reference from the forthcoming **2023 Proxy Statement** - Information for **Items 10 (Directors, Executive Officers and Corporate Governance), 11 (Executive Compensation), 12 (Security Ownership), 13 (Certain Relationships and Related Transactions)**, and **14 (Principal Accountant Fees and Services)** is incorporated by reference from the company's **2023 Proxy Statement**, to be filed within **120 days** of the fiscal year-end[551](index=551&type=chunk)[553](index=553&type=chunk)[554](index=554&type=chunk)[555](index=555&type=chunk)[556](index=556&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=120&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists all exhibits filed with the **10-K**, including corporate governance documents, material agreements, and various certifications - This section provides an index of all exhibits filed with the **10-K**, including corporate governance documents, material agreements (such as the loan agreement with **SVB** and manufacturing agreement with **rms Company**), and executive compensation plans[559](index=559&type=chunk)[560](index=560&type=chunk)[563](index=563&type=chunk)

SI-BONE, Inc. (NASDAQ:SIBN) Q4 2022 Earnings Conference Call February 27, 2023 4:30 PM ET Company Participants Saqib Iqbal - Director of Investor Relations Laura Francis - Chief Executive Officer Anshul Maheshwari - Chief Financial Officer Conference Call Participants Kyle Rose - Canaccord David Rescott - Truist Securities Craig Bijou - Bank of America Ross Osborn - Cantor Fitzgerald Dave Turkaly - JMP Securities Drew Ranieri - Morgan Stanley David Saxon - Needham & Company Operator Good afternoon, and welc ...

SI-BONE 1 Corporate Overview February 2023 Safe Harbor Statement This presentation contains "forward-looking statements," which are statements related to events, results, activities or developments that SI-BONE expects, believes or anticipates will or may occur in the future. Forward-looking often contain words such as "intends," "estimates," "anticipates," "hopes," "projects," "plans," "expects," "seek," "believes," "see," "should," "will," "would," "target," and similar expressions and the negative versio ...

SI-BONE, Inc. (NASDAQ:SIBN) Q3 2022 Earnings Conference Call November 7, 2022 4:30 PM ET Company Participants Marissa Bych - IR, Gilmartin Group Laura Francis - Chief Executive Officer Anshul Maheshwari - Chief Financial Officer Conference Call Participants Kyle Rose - Canaccord Craig Bijou - Bank of America David Rescott - Truist Securities Andrew Ranieri - Morgan Stanley David Turkaly - JMP Securities Ross Osborn - Cantor Fitzgerald Young Li - Jefferies David Saxon - Needham & Company Operator Good aftern ...

SI-BONE 1 Corporate Overview June 2022 Safe Harbor Statement This presentation contains "forward-looking statements," which are statements related to events, results, activities or developments that SI-BONE expects, believes or anticipates will or may occur in the future. Forward-looking often contain words such as "intends," "estimates," "anticipates," "hopes," "projects," "plans," "expects," "seek," "believes," "see," "should," "will," "would," "target," and similar expressions and the negative versions t ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission File Number: 001-38701 SI-BONE, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 26-2216351 (State or O ...

SI-BONE, Inc. (NASDAQ:SIBN) Q2 2022 Earnings Conference Call August 8, 2022 4:30 PM ET Company Participants Matt Bacso - IR, Gilmartin Group Laura Francis - Chief Executive Officer Anshul Maheshwari - Chief Financial Officer Conference Call Participants David Saxon - Needham & Company Craig Bijou - Bank of America David Rescott - Truist Securities Andrew Ranieri - Morgan Stanley David Turkaly - JMP Securities Operator Good afternoon, and welcome to SI-BONE's Second Quarter Earnings Conference Call. At this ...

[PART I-FINANCIAL INFORMATION](index=6&type=section&id=PART%20I-FINANCIAL%20INFORMATION) Presents the company's unaudited financial statements, management's discussion, market risk disclosures, and internal controls [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) Presents unaudited condensed consolidated financial statements for Q1 2022, showing increased revenue but a wider net loss [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Presents the company's financial position, detailing assets, liabilities, and equity at quarter-end Condensed Consolidated Balance Sheet Data (Unaudited) | Balance Sheet Item | March 31, 2022 (in thousands) | December 31, 2021 (in thousands) | | :--- | :--- | :--- | | **Total Current Assets** | $161,261 | $175,866 | | **Total Assets** | $176,849 | $190,506 | | **Total Current Liabilities** | $15,453 | $16,890 | | **Total Liabilities** | $54,411 | $56,086 | | **Total Stockholders' Equity** | $122,438 | $134,420 | - Cash and cash equivalents decreased significantly to **$27.3 million** from **$63.4 million** at the end of the previous year[15](index=15&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Details the company's financial performance, including revenue, expenses, and net loss for the period Statement of Operations Highlights (Three Months Ended March 31) | Metric | 2022 (in thousands) | 2021 (in thousands) | | :--- | :--- | :--- | | **Revenue** | $22,439 | $20,442 | | **Gross Profit** | $19,456 | $18,242 | | **Total Operating Expenses** | $36,324 | $29,817 | | **Loss from Operations** | $(16,868) | $(11,575) | | **Net Loss** | $(17,410) | $(12,242) | | **Net Loss Per Share** | $(0.52) | $(0.37) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Summarizes cash inflows and outflows from operating, investing, and financing activities Cash Flow Summary (Three Months Ended March 31) | Cash Flow Activity | 2022 (in thousands) | 2021 (in thousands) | | :--- | :--- | :--- | | **Net cash used in operating activities** | $(13,512) | $(9,359) | | **Net cash used in investing activities** | $(22,608) | $(7,122) | | **Net cash provided by financing activities** | $169 | $601 | | **Net decrease in cash and cash equivalents** | $(36,090) | $(16,217) | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Provides additional details and explanations for the financial statements, including accounting policies and significant transactions - The company operates as a single reportable and operating segment, deriving substantially all of its revenue from customers in the U.S.[32](index=32&type=chunk)[33](index=33&type=chunk) - In August 2021, the company entered into a **$35.0 million** term loan with Silicon Valley Bank (SVB), using the proceeds to repay and terminate a previous loan. The SVB Term Loan has an effective interest rate of **6.3%** for the quarter[57](index=57&type=chunk)[58](index=58&type=chunk) - Stock-based compensation expense for the quarter was **$5.5 million**, an increase from **$4.0 million** in the prior-year period, with sales and marketing being the largest component[69](index=69&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=27&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2022 financial performance, noting a 10% revenue increase, widened net loss, and sufficient liquidity [Overview](index=27&type=section&id=Overview) Provides a general introduction to the company's business, products, and market position - SI-BONE is a medical device company that pioneered the iFuse minimally invasive surgical implant system for sacropelvic disorders[80](index=80&type=chunk) - As of March 31, 2022, more than **65,000** procedures have been performed by over **2,700** surgeons in the U.S. and **36** other countries[80](index=80&type=chunk) - The company has expanded its product portfolio with iFuse-3D (2017), the Bedrock technique for spinal fusion (2019), and iFuse-TORQ for pelvic trauma (2021)[83](index=83&type=chunk)[84](index=84&type=chunk)[85](index=85&type=chunk) [Impact of COVID-19 Pandemic](index=28&type=section&id=Impact%20of%20COVID-19%20Pandemic) Discusses the ongoing effects of the COVID-19 pandemic on the company's operations and financial results - The COVID-19 pandemic continues to impact business by reducing elective procedures, limiting hospital access for sales staff, and causing supply chain disruptions for instruments[88](index=88&type=chunk)[89](index=89&type=chunk)[91](index=91&type=chunk) - Periodic resurgences of COVID-19, such as the Omicron variant, negatively impacted revenues in 2021 and early 2022 through case deferrals[89](index=89&type=chunk)[90](index=90&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) Analyzes the company's revenue, gross profit, operating expenses, and net loss for the reporting period Q1 2022 vs Q1 2021 Performance | Metric | Q1 2022 (in millions) | Q1 2021 (in millions) | % Change | | :--- | :--- | :--- | :--- | | **Revenue** | $22.4M | $20.4M | 10% | | **Gross Margin** | 87% | 89% | (2) p.p. | | **Sales & Marketing Expense** | $25.6M | $20.9M | 22% | | **Total Operating Expenses** | $36.3M | $29.8M | 22% | | **Net Loss** | ($17.4M) | ($12.2M) | 42% | - The **10%** revenue increase was driven by higher domestic and international case volumes and an increased number of active surgeons and sales personnel[118](index=118&type=chunk) - The **22%** increase in operating expenses was primarily due to higher employee-related costs from increased headcount, and a rise in travel, marketing, and training activities as COVID-19 restrictions eased[120](index=120&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) Assesses the company's ability to meet its short-term and long-term financial obligations and fund operations - As of March 31, 2022, the company had cash and marketable securities of **$130.7 million** and an accumulated deficit of **$313.3 million**[125](index=125&type=chunk)[126](index=126&type=chunk) - Management believes existing cash will be sufficient to fund operating expenses and capital expenditure requirements for the next **12 months** and beyond[127](index=127&type=chunk) - Net cash used in operating activities was **$13.5 million** for the quarter, an increase from **$9.4 million** in the prior year period, mainly due to a higher net loss and changes in working capital[135](index=135&type=chunk)[136](index=136&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Discusses exposure to market risks, including foreign currency and interest rate fluctuations, and their potential financial impact - The company has foreign currency risks related to revenue and expenses denominated in currencies other than the U.S. dollar, mainly the Euro[146](index=146&type=chunk) - Interest rate risk affects the market value of its cash equivalents and short-term investments, and the interest paid on its variable-rate long-term debt[148](index=148&type=chunk)[149](index=149&type=chunk) - A hypothetical **100 basis point increase** in interest rates would decrease the investment portfolio's fair value by **$0.4 million** and increase interest owed on debt by **$0.1 million** for the quarter ended March 31, 2022[150](index=150&type=chunk) [Item 4. Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, with no material changes in internal control over financial reporting - Management, including the CEO and CFO, concluded that as of March 31, 2022, the company's disclosure controls and procedures were effective at the reasonable assurance level[153](index=153&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[154](index=154&type=chunk) [PART II-OTHER INFORMATION](index=38&type=section&id=PART%20II-OTHER%20INFORMATION) Covers legal proceedings, risk factors, equity sales, and exhibits, providing additional context beyond financial statements [Item 1. Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in routine legal actions but reports no pending matters with a material adverse effect on its business - The company is not currently a party to any legal proceedings that it believes would have a material adverse effect on the company[155](index=155&type=chunk) [Item 1A. Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) Details significant risks including operating losses, COVID-19 impact, product reliance, competition, and reimbursement challenges - The company has a history of significant operating losses (**$17.4 million** in Q1 2022) and expects to continue incurring losses for the foreseeable future[159](index=159&type=chunk) - The COVID-19 pandemic continues to adversely affect business through reduced elective surgeries, limited hospital access, and supply chain disruptions, with the full long-term impact remaining uncertain[161](index=161&type=chunk)[162](index=162&type=chunk)[164](index=164&type=chunk) - The business is highly dependent on revenue from the iFuse family of products. Failure to grow the market for iFuse or any event impeding its sales could significantly harm financial results[193](index=193&type=chunk) - The business depends on adequate coverage and reimbursement from third-party payors; changes in policies or insufficient payment levels could hinder product adoption and reduce prices[168](index=168&type=chunk) - The company faces intense competition from major medical device companies with greater resources, such as Medtronic and Globus Medical, and the number of competitors has grown to more than **20**[187](index=187&type=chunk)[188](index=188&type=chunk)[189](index=189&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=81&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Reports no unregistered equity sales in Q1 2022 and confirms all IPO proceeds were used for general corporate purposes - There were no sales of unregistered equity securities during the three months ended March 31, 2022[338](index=338&type=chunk) - As of March 31, 2022, all net proceeds from the October 2018 IPO had been used for general corporate purposes[341](index=341&type=chunk) [Item 6. Exhibits](index=82&type=section&id=Item%206.%20Exhibits) Lists exhibits filed with the Form 10-Q, including CEO/CFO certifications and XBRL data, incorporating previously filed documents - This section lists exhibits filed with the report, including CEO/CFO certifications (Exhibits 31.1, 31.2, 32.1) and XBRL data files[348](index=348&type=chunk)

Financial Data and Key Metrics Changes - Total revenue for Q1 2022 was $22.4 million, representing a growth of approximately 10% compared to Q1 2021 [16][31] - U.S. revenue was $20.4 million, increasing by 9% year-over-year, while international revenue was $2.1 million, up 24% year-over-year [31] - Gross margin for Q1 2022 was 87%, down from 89% in the prior year period, impacted by a decline in average selling price (ASP) and increased operational costs [32] - Operating expenses increased by 22% to $36.3 million compared to $29.8 million in the prior year [32] - Net loss for Q1 2022 was $17.4 million, or $0.52 per diluted share, compared to a net loss of $12.2 million, or $0.37 per diluted share in the prior year [34] Business Line Data and Key Metrics Changes - The company experienced the highest monthly procedure volumes in its history in March 2022, despite COVID disruptions in January and February [16] - Approximately 160 U.S. procedures were deferred due to Omicron in Q1 2022, impacting revenue by over $1.4 million [17] - The sales team comprised 154 individuals at the end of Q1 2022, including 88 territory managers and 66 clinical support specialists [19] - The number of active surgeons performing at least one procedure in Q1 2022 grew by 17% year-over-year, totaling over 680 active surgeons [22] Market Data and Key Metrics Changes - The company increased its market share of sacropelvic surgical devices into the high 60% range, confirming the effectiveness of its product strategy [25] - The company is targeting a $250 million adjacent adult deformity market with the introduction of the iFuse Bedrock Granite product [15][63] Company Strategy and Development Direction - The company aims to extend its leadership position and drive long-term growth through sales infrastructure expansion and surgeon engagement initiatives [19][24] - The introduction of iFuse Granite is expected to enhance competitive positioning and accelerate growth in the adult deformity market [15][63] - The company is focusing on expanding its academic programs to educate surgical residents and fellows, having held approximately 175 academic programs to date [24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the recovery in procedure volumes and the potential for continued growth, despite macro uncertainties related to COVID-19 [35][44] - The company is maintaining its 2022 total revenue guidance of approximately $106 million to $108 million, representing growth of 18% to 20% compared to 2021 [35] - Management highlighted the importance of the Breakthrough Device Designation and proposed NTAP for iFuse Granite in driving future growth [12][84] Other Important Information - The company is investing in direct-to-patient marketing initiatives to increase awareness among patients suffering from chronic SI joint pain [28][91] - The company is focused on derisking its supply chain to ensure the availability of instruments and implants to support top-line growth [53] Q&A Session Summary Question: Growth guidance for the year - Management maintained the growth guidance due to macro uncertainties but expressed confidence in sequential growth based on recovery trends and investments made [40][44] Question: Operating expenses and inflationary costs - Management explained that the increase in operating expenses was due to planned investments in sales force expansion and R&D, along with inflationary pressures [45][46] Question: Gross margins and factors affecting them - Management detailed that gross margin compression was due to product mix, site of service mix, and increased operational costs, while maintaining a focus on high industry-leading margins [50][53] Question: Potential impact of iFuse Granite on commercial adoption - Management expressed optimism about the potential for iFuse Granite to accelerate adoption and drive growth in the adult deformity market [63][64] Question: Backlog and deferred cases - Management noted that while there is a backlog of deferred cases, they have not included potential revenue from this backlog in their guidance due to uncertainty [66][68] Question: Active surgeon count and productivity - Management confirmed a slight decrease in active surgeons quarter-over-quarter but noted a year-over-year increase, indicating strong retention and engagement [76][77] Question: Market opportunity for TORQ and trauma applications - Management highlighted the significant market opportunity for TORQ in trauma applications and ongoing investments to educate trauma surgeons [87]

Market Opportunity & Leadership - SI-BONE addresses a large market with a $2.5 billion annual U S opportunity in SI joint fusion[7, 24] - The company has performed over 65,000 procedures worldwide using iFuse Technology[7, 19, 74] and has a majority estimated U S market share in iFuse[7] - The company estimates a ~$250 million Adult Spinal Deformity market opportunity[15] Clinical & Technological Advantages - iFuse demonstrates 6x resistance compared to SI screws and 3x strength compared to standard 8 0mm cannulated screws[37] - The SALLY Prospective Clinical Trial of iFuse-3D showed a 57-point improvement in VAS Pain Reduction and a 25-point improvement in ODI Disability[48] - The company has secured 61 issued patents and 44 pending patents, with iFuse patents covering until November 2024 and iFuse-3D patents covering until September 2035[38] Financial Performance & Growth Strategy - SI-BONE's worldwide revenue for the first quarter of 2022 was $22.4 million[17] - The company achieved a gross margin of approximately 87% in the first quarter of 2022[17, 67] - The company anticipates revenue between $106 million and $108 million for the full year 2022, representing an implied growth of 18%-20%[64]