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SI-BONE(SIBN) - 2021 Q4 - Earnings Call Presentation
2022-03-04 19:25
SI-BONE 1 Corporate Overview February 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 versio ...
SI-BONE(SIBN) - 2021 Q4 - Annual Report
2022-03-01 21:03
Part I [Business](index=7&type=section&id=Item%201.%20Business) SI-BONE specializes in sacropelvic medical devices, marketing its iFuse Implant System globally through direct sales and distributors, driven by surgeon training, clinical data, and new product development - SI-BONE is a medical device company focused on musculoskeletal disorders of the sacropelvic anatomy, pioneering the **iFuse minimally invasive surgical system**[21](index=21&type=chunk) Financial Performance (2020-2021) | Metric | 2021 | 2020 | | :--- | :--- | :--- | | **Revenue** | $90.2 million | $73.4 million | | **Net Loss** | $56.6 million | $43.7 million | | **Gross Margin** | 88% | 88% | - As of December 31, 2021, approximately **65,000 iFuse procedures** have been performed by over **2,600 surgeons** in the United States and more than **36 other countries**[21](index=21&type=chunk) - The company markets products through a direct sales force and distributors in the U.S. and internationally, with substantially all revenue derived from **iFuse implant sales**[28](index=28&type=chunk) [Overview](index=7&type=section&id=Item%201.%20Business%20-%20Overview) SI-BONE's iFuse Implant System, a minimally invasive solution for sacropelvic disorders, has performed 65,000 procedures globally, driving 23% revenue growth to $90.2 million in 2021 with 88% gross margins - The company's core product, the **iFuse Implant System**, features patented titanium implants and specialized instruments for minimally invasive sacroiliac joint fusion[23](index=23&type=chunk) - Key product innovations include the **iFuse-3D** (2017), a 3D-printed porous implant, and **iFuse-TORQ** (2021), a threaded implant for pelvic fractures and SI joint fusion[25](index=25&type=chunk)[27](index=27&type=chunk) - The company received **FDA clearance** for the **Bedrock technique** in April 2019 for multi-level spinal fusion, and an expanded trauma indication in March 2020[26](index=26&type=chunk) [Market Opportunity](index=10&type=section&id=Item%201.%20Business%20-%20Market%20Opportunity) SI-BONE estimates a substantial U.S. market opportunity for sacroiliac joint fusion at **$2.5 billion** annually, with additional markets for Bedrock technique at **$200 million** and iFuse-TORQ at **$350 million** Estimated Annual U.S. Market Opportunities | Indication | Estimated Annual Market Size | | :--- | :--- | | Sacroiliac Joint Fusion | ~$2.5 billion | | Spinopelvic Fixation (Bedrock) | ~$200 million | | Pelvic Trauma (iFuse-TORQ) | ~$350 million | - The number of iFuse procedures performed globally increased from **53,000** to approximately **65,000** between December 31, 2020, and December 31, 2021[35](index=35&type=chunk) [Our Solution and Published Studies](index=12&type=section&id=Item%201.%20Business%20-%20Our%20Solution%20and%20Published%20Studies) The iFuse Implant System's triangular implants offer immediate stability and fusion, supported by over **100 publications** including randomized controlled trials and long-term studies demonstrating sustained improvements - The **triangular cross-section** of iFuse implants resists rotation and provides immediate joint stability, while the porous surface facilitates bony ongrowth and ingrowth for fusion[44](index=44&type=chunk)[45](index=45&type=chunk) - The company's clinical evidence portfolio includes over **100 publications**, featuring two prospective randomized controlled trials (**INSITE** and **iMIA**) and long-term data out to six years[54](index=54&type=chunk) - The **LOIS five-year follow-up study** demonstrated sustained improvements in pain and disability, high patient satisfaction, and an **88% SI joint fusion rate** with no device-related adverse events[58](index=58&type=chunk) [Coverage, Sales, and Marketing](index=16&type=section&id=Item%201.%20Business%20-%20Coverage%2C%20Sales%2C%20and%20Marketing) SI-BONE has near-universal U.S. payor coverage for minimally invasive SI joint fusion, with **160 million lives** covered exclusively for its triangular implants, supported by a direct sales force and targeted marketing - As of December 31, 2021, near-universal coverage exists for minimally invasive SI joint fusion, with private payors covering approximately **160 million lives** adopting policies exclusive to **SI-BONE's triangular iFuse implants**[66](index=66&type=chunk) Sales Force Headcount (as of Dec 31, 2021) | Region | Direct Territory Sales Managers | Direct Clinical Specialists | Third-Party Distributors | | :--- | :--- | :--- | :--- | | **U.S.** | 85 | 65 | 59 | | **International** | 20 | N/A | 32 | - The company invests in direct-to-patient marketing via digital channels, social media, TV, and radio to increase awareness of sacroiliac joint disorders as a source of lower back pain[77](index=77&type=chunk) [Competition and Intellectual Property](index=18&type=section&id=Item%201.%20Business%20-%20Competition%20and%20Intellectual%20Property) SI-BONE competes with major medical device firms, differentiating through its proprietary triangular implant design and extensive clinical evidence, with key patents expiring in **November 2024** and **September 2035** - Primary competitors include **Globus Medical, Inc.** and **Medtronic plc**, selling screw-based products, and companies marketing allograft bone implants[83](index=83&type=chunk) - The company's key competitive advantages are its differentiated **triangular implant design** and substantial published clinical evidence demonstrating safety, effectiveness, and economic utility, leading to exclusive payor coverage[84](index=84&type=chunk) Key Patent Expiration Dates | Product/Feature | Jurisdiction | Expiration Date | | :--- | :--- | :--- | | iFuse (triangular shape) | U.S. | November 2024 | | iFuse-3D (fenestrated design) | U.S. | September 2035 | | Foreign Patents | Various | August 2025 - September 2035 | [Regulation](index=22&type=section&id=Item%201.%20Business%20-%20Regulation) SI-BONE's products are extensively regulated by the FDA (510(k) clearances) and international bodies (MDR, CE marking), also subject to healthcare fraud and abuse laws (Anti-Kickback Statute, Sunshine Act) and data privacy regulations (HIPAA, GDPR) - In the U.S., **SI-BONE's products** are regulated by the **FDA**, with most products having received **510(k) premarket clearance**; the first iFuse implant clearance was in November 2008[90](index=90&type=chunk)[112](index=112&type=chunk) - In the EEA, products require a **CE Certificate of Conformity**, with the company transitioning to compliance with the new, stricter **Medical Device Regulation (MDR 2017/745)**, effective May 2021[108](index=108&type=chunk)[243](index=243&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**, governing financial relationships with healthcare providers[118](index=118&type=chunk)[119](index=119&type=chunk) - Data privacy and security are governed by laws such as **HIPAA** in the U.S. and **GDPR** in the EU, imposing strict obligations on handling patient health information[122](index=122&type=chunk)[125](index=125&type=chunk) [Manufacturing and Human Capital](index=35&type=section&id=Item%201.%20Business%20-%20Manufacturing%20and%20Human%20Capital) SI-BONE outsources manufacturing to third-party suppliers like RMS, complying with QSR and ISO 13485, and as of December 31, 2021, had **352 employees** with a focus on diversity, health, and talent development - The company relies on third-party manufacturers, with a key non-exclusive agreement with **rms Company (RMS)** for **iFuse-3D implant production**[128](index=128&type=chunk)[129](index=129&type=chunk) - As of December 31, 2021, the company had **352 employees**, including **150 U.S. direct field sales** and **20 European sales**, with a 2021 employee turnover rate of less than **20%**[137](index=137&type=chunk) - The company has a **Diversity and Inclusion Plan**, with its board composition including **four women** and **two Asian American members** out of nine total directors[138](index=138&type=chunk)[139](index=139&type=chunk) - Due to its public float exceeding **$700 million**, the company became a **large accelerated filer** as of December 31, 2021, no longer qualifying as an "emerging growth company"[152](index=152&type=chunk) [Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) The company faces risks from operating losses, COVID-19 impacts, reimbursement dependency, intense competition, reliance on the iFuse product family and limited suppliers, extensive regulation, and intellectual property disputes - The company has a history of significant operating losses, with a **net loss of $56.6 million** in 2021 and an **accumulated deficit of $295.8 million**, expecting future losses[156](index=156&type=chunk) - The **COVID-19 pandemic** has adversely impacted operations by suspending elective surgeries and may continue to disrupt demand, supply chains, and financial markets[158](index=158&type=chunk)[159](index=159&type=chunk) - The business is highly dependent on revenue from the **iFuse product family**, and any failure to maintain market acceptance or grow sales could negatively affect financial results[187](index=187&type=chunk) - The company relies on a limited number of third-party suppliers, including **single-source suppliers** for critical components like the **iFuse-3D implant**, making it vulnerable to supply disruptions[201](index=201&type=chunk)[203](index=203&type=chunk) [Risks Related to Our Business and Our Industry](index=40&type=section&id=Item%201A.%20Risk%20Factors%20-%20Business%20and%20Industry) Key business risks include operating losses, COVID-19 impacts, reimbursement dependency, intense competition, and high reliance on the iFuse product family and limited third-party manufacturers - The company has incurred significant operating losses since inception and may not achieve or sustain profitability[156](index=156&type=chunk) - Dependence on adequate coverage and reimbursement from third-party payors is critical; insufficient reimbursement may delay or prevent product adoption[164](index=164&type=chunk) - The company operates in a very competitive environment against large, well-resourced competitors like **Medtronic** and **Globus Medical**[182](index=182&type=chunk)[184](index=184&type=chunk) - Substantially all revenue comes from the **iFuse product family**, making the company highly dependent on its success and vulnerable to market shifts or issues with this single product line[187](index=187&type=chunk) [Risks Related to Our Legal and Regulatory Environment](index=55&type=section&id=Item%201A.%20Risk%20Factors%20-%20Legal%20and%20Regulatory) The company faces extensive U.S. and international regulation, risking penalties for non-compliance, potential stricter premarket approvals, and adherence to anti-kickback, false claims, and data privacy laws, with off-label promotion prohibited - The company and its suppliers are subject to extensive governmental regulation (e.g., **FDA's QSR**), and non-compliance could lead to enforcement actions like fines, recalls, or production suspension[236](index=236&type=chunk)[244](index=244&type=chunk) - Compliance with U.S. federal and state fraud and abuse laws (e.g., **Anti-Kickback Statute**, **False Claims Act**) is critical, with violations potentially resulting in severe civil and criminal penalties[248](index=248&type=chunk)[249](index=249&type=chunk) - Promotional materials and training must not constitute "**off-label**" promotion of unapproved uses, which could lead to regulatory enforcement, fines, and reputational damage[266](index=266&type=chunk) - Modifications to existing **510(k)-cleared products** may require new clearances, and an incorrect determination could lead to recalls or marketing cessation until clearance is obtained[275](index=275&type=chunk) [Risks Related to Our Intellectual Property](index=71&type=section&id=Item%201A.%20Risk%20Factors%20-%20Intellectual%20Property) The company's competitive position relies on intellectual property protection, facing risks from key patent expirations in **late 2024**, potential costly patent litigation, and claims of wrongful use of competitors' trade secrets - The company's U.S. patents on the original **iFuse triangular shape** expire in **November 2024**, potentially allowing competitors to introduce similar devices[300](index=300&type=chunk) - The medical device industry is characterized by significant patent litigation, and the company could become subject to costly infringement claims that could prevent it from selling its products[308](index=308&type=chunk) - The company may face claims that its employees or distributors have wrongfully used or disclosed trade secrets from competitors, leading to litigation and potential loss of intellectual property[307](index=307&type=chunk) [Risks Related to Ownership of Our Common Stock](index=73&type=section&id=Item%201A.%20Risk%20Factors%20-%20Ownership%20of%20Common%20Stock) SI-BONE's common stock faces price volatility, anti-takeover provisions, and potential limitations on utilizing **$255.5 million** federal and **$203.2 million** state net operating loss carryforwards due to Section 382 rules - The price of the company's common stock may be volatile due to fluctuating operating results, regulatory actions, and general market conditions[310](index=310&type=chunk) - As of December 31, 2021, the company had significant federal (**$255.5 million**) and state (**$203.2 million**) net operating loss (NOL) carryforwards, but their future use may be limited by **Section 382 ownership change rules**[315](index=315&type=chunk) - The company's charter documents contain anti-takeover provisions, such as a **classified board** and restrictions on calling special meetings, which could deter potential acquirers[318](index=318&type=chunk)[319](index=319&type=chunk) [Unresolved Staff Comments](index=77&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the Securities and Exchange Commission - None [Properties](index=77&type=section&id=Item%202.%20Properties) The company's principal executive offices are a leased **21,848 square foot** facility in Santa Clara, California, with additional leased R&D, warehouse, and office spaces internationally - The company's headquarters is a leased space of approximately **21,848 square feet** in Santa Clara, California, with the lease expiring in **May 2025**[326](index=326&type=chunk) - Additional facilities are leased in Santa Clara, CA (R&D/warehouse), Gallarate, Italy, Mannheim, Germany, and Knaresborough, United Kingdom to support European operations[326](index=326&type=chunk) [Legal Proceedings](index=77&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings that would significantly adversely affect its operations - The company is not currently involved in any material legal proceedings[327](index=327&type=chunk) [Mine Safety Disclosures](index=77&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's business - Not Applicable Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=78&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) SI-BONE's common stock trades on Nasdaq under "SIBN"; the company has never paid dividends, and **$85.4 million** of IPO proceeds were used for general corporate purposes by December 31, 2021 - The company's common stock is listed on the **Nasdaq Global Market** under the symbol "**SIBN**"[330](index=330&type=chunk) - The company has never declared or paid cash dividends and does not plan to in the foreseeable future[332](index=332&type=chunk) - As of December 31, 2021, approximately **$85.4 million** of the net proceeds from the **2018 IPO** had been used for general corporate purposes, including operations and capital expenditures[334](index=334&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=79&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Revenue grew **23%** to **$90.2 million** in 2021, but operating expenses rose **27%** to **$131.4 million**, widening net loss to **$56.6 million**, with **$147.0 million** cash on hand and growth driven by sales force expansion and new products 2021 vs. 2020 Results of Operations | Metric | 2021 | 2020 | % Change | | :--- | :--- | :--- | :--- | | **Revenue** | $90.2M | $73.4M | 23% | | **Gross Profit** | $79.7M | $64.5M | 24% | | **Gross Margin** | 88% | 88% | 0% | | **Operating Expenses** | $131.4M | $103.1M | 27% | | **Loss from Operations** | ($51.7M) | ($38.6M) | 34% | | **Net Loss** | ($56.6M) | ($43.7M) | 30% | - The increase in revenue was driven by higher domestic and international case volumes, an expanded sales organization, and an increase in the number of active surgeons[374](index=374&type=chunk) - Operating expenses increased significantly due to higher employee-related costs from increased headcount (**$11.2 million** in S&M, **$1.6 million** in R&D, **$3.4 million** in G&A) and a **$7.8 million** increase in travel, marketing, and training as COVID-19 restrictions eased[376](index=376&type=chunk)[377](index=377&type=chunk)[378](index=378&type=chunk) - As of December 31, 2021, the company had **$147.0 million** in cash and marketable securities and an **accumulated deficit of $295.8 million**[383](index=383&type=chunk)[384](index=384&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=91&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company is not yet required to provide quantitative and qualitative disclosures about market risk, despite becoming a large accelerated filer as of December 31, 2021 - As a former smaller reporting company that recently became a large accelerated filer, the company is not yet required to provide the disclosures for this item[402](index=402&type=chunk) [Financial Statements and Supplementary Data](index=92&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents audited consolidated financial statements for 2021 and 2020, with PricewaterhouseCoopers LLP providing an unqualified opinion on financials and internal controls, detailing **$190.5 million** total assets and **$56.1 million** total liabilities Consolidated Balance Sheet Data (as of Dec 31, 2021) | Account | Amount (in thousands) | | :--- | :--- | | **Total Current Assets** | $175,866 | | **Total Assets** | $190,506 | | **Total Current Liabilities** | $16,890 | | **Total Liabilities** | $56,086 | | **Total Stockholders' Equity** | $134,420 | Consolidated Statement of Operations Data (Year Ended Dec 31, 2021) | Account | Amount (in thousands) | | :--- | :--- | | **Revenue** | $90,152 | | **Gross Profit** | $79,724 | | **Loss from Operations** | ($51,670) | | **Net Loss** | ($56,572) | | **Net Loss Per Share** | ($1.71) | - The independent auditor, **PricewaterhouseCoopers LLP**, issued an **unqualified opinion** on the financial statements and on the effectiveness of internal control over financial reporting as of December 31, 2021[408](index=408&type=chunk) - The company adopted the new lease accounting standard (**ASC 842**) effective January 1, 2021, recognizing **$3.8 million** of operating lease liabilities and **$3.5 million** of right-of-use assets on the balance sheet[486](index=486&type=chunk) [Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=123&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants regarding accounting principles, practices, or financial disclosure - None [Controls and Procedures](index=123&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded disclosure controls and internal control over financial reporting were effective as of December 31, 2021, with no material changes reported in Q4 2021 - Management concluded that the company's **disclosure controls and procedures** were effective as of December 31, 2021[575](index=575&type=chunk) - Management's report concluded that **internal control over financial reporting** was effective as of December 31, 2021, an assessment audited and agreed upon by **PricewaterhouseCoopers LLP**[576](index=576&type=chunk) - There were no changes in internal control over financial reporting during the fourth quarter of 2021 that materially affected, or are reasonably likely to materially affect, internal controls[577](index=577&type=chunk) [Other Information](index=123&type=section&id=Item%209B.%20Other%20Information) The company reports no other information for this item - None Part III [Directors, Executive Officers and Corporate Governance](index=125&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information on directors, executive officers, and corporate governance, including the code of ethics, is incorporated by reference from the 2022 Proxy Statement - Required information is incorporated by reference from the forthcoming **2022 Proxy Statement**[581](index=581&type=chunk) - The company has adopted a **Code of Business Conduct and Ethics**, available on its website, applicable to all officers, directors, and employees[582](index=582&type=chunk) [Executive Compensation](index=125&type=section&id=Item%2011.%20Executive%20Compensation) Information regarding executive and director compensation is incorporated by reference from the 2022 Proxy Statement - Required information will be found in the "Executive Compensation" and "Compensation of Non-Employee Board Members" sections of the 2022 Proxy Statement[583](index=583&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=125&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information on security ownership by beneficial owners and management, and equity compensation plans, is incorporated by reference from the 2022 Proxy Statement - Required information will be found in the "Security Ownership of Certain Beneficial Owners and Management" and "Securities Authorized for Issuance Under Equity Compensation Plans" sections of the 2022 Proxy Statement[584](index=584&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=125&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information on related party transactions and director independence is incorporated by reference from the 2022 Proxy Statement - Required information will be found in the "Certain Relationships and Related Party Transactions" and "Information Regarding the Board of Directors and Corporate Governance" sections of the 2022 Proxy Statement[585](index=585&type=chunk) [Principal Accountant Fees and Services](index=125&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Information regarding fees paid to and services provided by the principal independent accountant is incorporated by reference from the 2022 Proxy Statement - Required information will be found in the "Principal Accountant Fees and Services" section of the 2022 Proxy Statement[586](index=586&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=126&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists all financial statements and a detailed index of exhibits filed with or incorporated by reference into the Annual Report on Form 10-K - This item lists all financial statements, schedules, and exhibits filed with the report[589](index=589&type=chunk) - The exhibit index includes key documents such as the **Amended and Restated Certificate of Incorporation**, bylaws, equity incentive plans, and material agreements like the manufacturing agreement with **rms Company** and the loan agreement with **Silicon Valley Bank**[591](index=591&type=chunk)[594](index=594&type=chunk) [Form 10-K Summary](index=128&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company indicates that a Form 10-K summary is not provided - Not provided
SI-BONE(SIBN) - 2021 Q4 - Earnings Call Transcript
2022-03-01 03:53
SI-BONE, Inc. (NASDAQ:SIBN) Q4 2021 Earnings Conference Call February 28, 2022 4:30 PM ET Company Participants Matt Basco - IR, Gilmartin Group Laura Francis - Chief Executive Officer Anshul Maheshwari - Chief Financial Officer Conference Call Participants Craig Bijou - Bank of America Kyle Rose - Canaccord David Rescott - Truist Securities David Saxon - Needham Drew Ranieri - Morgan Stanley Dave Turkaly - JMP Securities Disclaimer*: This transcript is designed to be used alongside the freely available audi ...
SI-BONE (SIBN) Investor Presentation - Slideshow
2022-01-21 19:50
Market Opportunity & Leadership - The company addresses a large market with a $2.5 billion annual U S opportunity[7] - The company has pioneered sacropelvic surgical solutions, with approximately 65,000 procedures performed worldwide using iFuse Technology[7, 21, 82] - The company estimates a majority U S market share with iFuse[7] Clinical & Technological Advantages - The company has over 35 exclusive payor policies and approximately 160 million U S exclusive covered lives[7, 8, 21, 68, 82] - The company's iFuse demonstrates 6x resistance compared to SI screws[33] - The company's iFuse demonstrates 3x strength compared to standard 8 0mm cannulated screws[33] - The company's iFuse-3D shows 57-point improvement in VAS Pain Reduction and 25-point improvement in ODI Disability[47] Financial Performance & Growth - The company anticipates record FY21 revenue of $89 8 - $90 1 million, representing a year-over-year growth of 22-23%[63, 70, 75] - The company maintains a strong annual gross margin between 87% and 89%[61, 71] - The company has approximately $146 million in cash and equivalents as of December 31, 2021[75]
SI-BONE(SIBN) - 2021 Q3 - Quarterly Report
2021-11-09 21:10
[PART I-FINANCIAL INFORMATION](index=5&type=section&id=PART%20I-FINANCIAL%20INFORMATION) [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for the three and nine months ended September 30, 2021, highlighting revenue growth alongside a widening net loss Condensed Consolidated Balance Sheet Data (Unaudited) | (In thousands) | September 30, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $59,863 | $53,581 | | Short-term investments | $100,988 | $142,851 | | Total current assets | $185,648 | $218,241 | | TOTAL ASSETS | $193,966 | $223,142 | | **Liabilities & Equity** | | | | Total current liabilities | $14,564 | $13,470 | | Long-term borrowings | $34,922 | $39,455 | | TOTAL LIABILITIES | $50,348 | $53,779 | | TOTAL STOCKHOLDERS' EQUITY | $143,618 | $169,363 | Condensed Consolidated Statements of Operations Data (Unaudited) | (In thousands, except per share data) | Three Months Ended Sep 30, 2021 | Three Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $22,286 | $20,373 | $64,922 | $51,243 | | Gross profit | $19,808 | $17,795 | $57,869 | $44,616 | | Loss from operations | $(13,199) | $(8,675) | $(37,739) | $(30,696) | | Net loss | $(15,872) | $(9,474) | $(42,095) | $(34,718) | | Net loss per share, basic and diluted | $(0.48) | $(0.33) | $(1.28) | $(1.23) | Condensed Consolidated Statements of Cash Flows Data (Unaudited) | (In thousands) | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(26,819) | $(22,780) | | Net cash provided by investing activities | $36,202 | $4,903 | | Net cash provided by (used in) financing activities | $(2,726) | $63,363 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial performance, noting revenue growth despite COVID-19 impacts, increased operating expenses, and a debt refinancing to improve liquidity - The resurgence of the COVID-19 pandemic driven by the Delta variant negatively impacted revenues for the three months ended September 30, 2021, with increased case cancellations recorded in August and September 2021[88](index=88&type=chunk) - The U.S. sales force expanded to **78 territory sales managers** and **57 clinical support specialists** as of September 30, 2021, up from 59 and 57, respectively, a year prior[95](index=95&type=chunk) - Major payors, including Centene, Anthem, and UnitedHealthcare, established or expanded positive coverage for iFuse, with UnitedHealthcare's policy exclusively covering SI-BONE's triangular iFuse implants effective October 1, 2021[102](index=102&type=chunk) Revenue Comparison (Q3 2021 vs Q3 2020) | (In thousands) | Q3 2021 | Q3 2020 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Revenue | $22,286 | $20,373 | $1,913 | 9% | | Gross Profit | $19,808 | $17,795 | $2,013 | 11% | Operating Expense Comparison (Q3 2021 vs Q3 2020) | (In thousands) | Q3 2021 | Q3 2020 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Sales and marketing | $23,525 | $18,772 | $4,753 | 25% | | Research and development | $3,288 | $2,778 | $510 | 18% | | General and administrative | $6,194 | $4,920 | $1,274 | 26% | - In August 2021, the company refinanced its debt, terminating the Solar Term Loan and entering a new **$35.0 million term loan** with Silicon Valley Bank, resulting in a **one-time loss on extinguishment of $1.8 million** but providing a lower interest rate[123](index=123&type=chunk)[137](index=137&type=chunk)[139](index=139&type=chunk) - As of September 30, 2021, the company had **cash and marketable securities of $160.9 million** and believes this is sufficient to fund operations and capital expenditures for at least the next 12 months[134](index=134&type=chunk)[136](index=136&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a "smaller reporting company," the company is exempt from providing quantitative and qualitative disclosures about market risk - As a "smaller reporting company," SI-BONE is not required to provide the information otherwise required by this Item[155](index=155&type=chunk) [Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of September 30, 2021, with no material changes to internal controls during the quarter - Based on an evaluation as of September 30, 2021, the CEO and CFO concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[158](index=158&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended September 30, 2021, that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[159](index=159&type=chunk) [PART II-OTHER INFORMATION](index=38&type=section&id=PART%20II-OTHER%20INFORMATION) [Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in routine legal actions but currently believes no pending matters are material to its financial condition or operations - The company is involved in various claims, complaints, and legal actions in the normal course of business, but there are no pending matters currently believed to be material[160](index=160&type=chunk) [Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) This section details significant business risks, including historical operating losses, COVID-19 impacts, reimbursement dependency, intense competition, reliance on the iFuse product, supply chain vulnerabilities, and extensive regulatory compliance - The company has a history of significant operating losses, with a **net loss of $42.1 million** for the nine months ended September 30, 2021, and expects to continue incurring losses[165](index=165&type=chunk) - The COVID-19 pandemic has had, and is expected to continue to have, an adverse impact on operations, including unpredictable reductions in demand for products and delays in elective surgeries[169](index=169&type=chunk) - The business is highly dependent on adequate coverage and reimbursement from third-party payors, and a reversal of exclusive iFuse coverage decisions could reduce market share[173](index=173&type=chunk)[181](index=181&type=chunk) - The company faces intense competition from major medical device companies like Medtronic and Globus Medical, as well as over 20 smaller companies, leading to significant pricing pressure[193](index=193&type=chunk)[194](index=194&type=chunk)[195](index=195&type=chunk) - Substantially all revenue comes from the iFuse product family, making the company highly dependent on the success of this single product line[198](index=198&type=chunk) - The company relies on a limited number of third-party suppliers, some of which are single-source, for its products and components, exposing it to supply chain risks[211](index=211&type=chunk) - The business is subject to extensive and stringent governmental regulation in the U.S. (FDA) and abroad (e.g., EU Medical Device Regulation), and non-compliance could result in significant penalties and business disruption[244](index=244&type=chunk)[254](index=254&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=85&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered equity sales in Q3 2021 and details the use of **$104.1 million** from its 2018 IPO for general corporate purposes - There were no sales of unregistered equity securities during the three months ended September 30, 2021[337](index=337&type=chunk) - As of September 30, 2021, approximately **$104.1 million** of the net proceeds from the October 2018 IPO had been used for general corporate purposes[340](index=340&type=chunk) [Defaults Upon Senior Securities](index=85&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon its senior securities - None[341](index=341&type=chunk) [Mine Safety Disclosures](index=85&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not Applicable[342](index=342&type=chunk) [Other Information](index=85&type=section&id=Item%205.%20Other%20Information) On October 20, 2021, the company amended Executive Chairman Jeffery Dunn's employment and severance agreement, modifying change-of-control benefits and the definition of "Good Reason" - On October 20, 2021, the company entered into a Second Amendment to the Offer Letter Agreement and Severance Plan Participation Agreement with Jeffery Dunn, its Executive Chairman[343](index=343&type=chunk) - The amendment modifies Mr. Dunn's entitlement to severance benefits upon a Change in Control and alters the definition of "Good Reason" for termination[343](index=343&type=chunk) [Exhibits](index=86&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including the Loan and Security Agreement, an employment agreement amendment, and required officer certifications - Lists exhibits filed with the report, including the Loan and Security Agreement with Silicon Valley Bank (Exhibit 10.1) and the Second Amendment to Jeffery Dunn's employment agreement (Exhibit 10.2)[346](index=346&type=chunk) - Includes certifications from the CEO and CFO as required by Sections 302 and 906 of the Sarbanes-Oxley Act of 2002[346](index=346&type=chunk)
SI-BONE(SIBN) - 2021 Q3 - Earnings Call Presentation
2021-11-09 19:25
| --- | --- | --- | --- | --- | --- | |--------------------|-------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Corporate Overview | | | | | | | November 2021 | | | | | | | | | | | | | | | | | | | | 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 of ...
SI-BONE(SIBN) - 2021 Q3 - Earnings Call Transcript
2021-11-09 02:10
SI-BONE, Inc. (NASDAQ:SIBN) Q3 2021 Earnings Conference Call November 8, 2021 4:30 PM ET Company Participants Matt Bacso – Gilmartin Group Laura Francis – Chief Executive Officer Anshul Maheshwari – Chief Financial Officer Conference Call Participants Brandon Folkes – Cantor Fitzgerald Drew Ranieri – Morgan Stanley Craig Bijou – Bank of America David Saxon – Needham David Rescott – Truist Securities Dave Turkaly – JMP Securities Kyle Rose – Canaccord Operator Good afternoon, and welcome to SI-BONE Third Qua ...
SI-BONE(SIBN) - 2021 Q2 - Quarterly Report
2021-08-04 20:27
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, 2021 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(SIBN) - 2021 Q2 - Earnings Call Presentation
2021-08-03 11:39
SI-BONE 1 Corporate Overview August 2021 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 ...
SI-BONE(SIBN) - 2021 Q2 - Earnings Call Transcript
2021-08-03 02:53
SI-BONE, Inc. (NASDAQ:SIBN) Q2 2021 Earnings Conference Call August 2, 2021 4:30 PM ET Company Participants Matthew Bacso - Gilmartin Group Laura Francis - CEO & Director Anshul Maheshwari - CFO Conference Call Participants Robert Hopkins - Bank of America Merrill Lynch Kyle Rose - Canaccord Genuity David Rescott - Truist Securities Brandon Folkes - Cantor Fitzgerald & Co. David Saxon - Needham & Company Andrew Ranieri - Morgan Stanley David Turkaly - JMP Securities Matthew Henriksson - Citigroup Operator G ...