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]

Financial Data and Key Metrics Changes - The company reported worldwide revenue of $48.6 million for Q2 2025, representing a growth of 21.7% year-over-year [30] - U.S. revenue was $46.4 million, reflecting a growth of 22.8% [31] - The net loss narrowed to $6.2 million or $0.14 per diluted share compared to a net loss of $8.9 million or $0.22 per diluted share in the prior year [34] - Positive adjusted EBITDA of $1 million was achieved, compared to an adjusted EBITDA loss of $2.7 million in the prior year [34] - Cash and marketable securities increased to $145.5 million, marking the first quarter of cash flow breakeven [35] Business Line Data and Key Metrics Changes - U.S. procedure volume increased by 25%, with double-digit growth across all modalities [32][9] - The physician base grew by 25%, reaching a record of 1,440 U.S. physicians performing procedures [21] - The average territory productivity reached $2.1 million, representing a 23% growth year-over-year [24] Market Data and Key Metrics Changes - International revenue was $2.2 million, impacted by delayed regulatory clearance for the iFuse Torque product [32] - The company expects the iFuse Torque to boost revenue growth in Europe in 2026 and beyond [32] Company Strategy and Development Direction - The company aims to build a platform of solutions targeting challenging procedures, improving surgical outcomes with lower failure rates [5][6] - Focus on innovation, physician engagement, commercial execution, and operational excellence as key priorities [11] - The company plans to expand its product offerings and enhance its market presence, particularly in the outpatient setting [88] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the demand across the portfolio and highlighted the strong growth momentum [44] - The company is optimistic about achieving positive adjusted EBITDA for the full year of 2025 and beyond [36] - Management noted that the regulatory changes proposed by CMS could provide additional tailwinds for the business [17] Other Important Information - The company announced the retirement of Tony Recoupero, President of Commercial Operations, effective February 2026, with Nicholas Kerr set to take over [26][27] - The company is preparing to launch a new SI joint product in 2026, which is expected to simplify workflow and expand engagement with interventionalists [20][88] Q&A Session Summary Question: Guidance on top line growth and assumptions for the second half - Management highlighted strong first half performance and discussed the potential for continued growth, with a sequential decline expected in Q3 due to seasonality [40][46] Question: Gross margin guidance and pricing pressure - Management provided insights on gross margin expectations, indicating a potential decline due to ASP pressure but also noted sticky improvements from supply chain efficiencies [50][56] Question: Growth of interventional doctors using products - Management confirmed strong growth in interventional doctors and noted that many are using multiple products, enhancing overall engagement [60][62] Question: Outpatient procedure opportunities - Management discussed the shift towards outpatient settings for certain procedures and the potential for increased adoption of their products in this market [66] Question: Expansion of territories and agents - Management confirmed plans to expand to approximately 100 territories over the next 15 months, while also increasing the number of agents to support growth [75][76] Question: Momentum across the product portfolio - Management reported strong demand for existing solutions and rapid adoption of new products, with a focus on maximizing physician potential [81][84] Question: Cash flow and capital deployment priorities - Management indicated a balanced approach to capital deployment, focusing on continued investment in R&D and commercial initiatives while maintaining strong cash flow [103]

Financial Data and Key Metrics Changes - Worldwide revenue for Q2 2025 was $48.6 million, representing a growth of 21.7% year-over-year [30] - U.S. revenue was $46.4 million, reflecting a growth of 22.8% [31] - Adjusted EBITDA was positive at $1 million, compared to an adjusted EBITDA loss of $2.7 million in the prior year [34] - Net loss narrowed to $6.2 million or $0.14 per diluted share, compared to a net loss of $8.9 million or $0.22 per diluted share in the prior year [34] - Cash and marketable securities increased to $145.5 million, marking the first quarter of cash flow breakeven [35] Business Line Data and Key Metrics Changes - U.S. procedure volume increased by 25%, with double-digit growth across all modalities [10][32] - The physician base grew by 25%, reaching a record of 1,440 U.S. physicians performing procedures [22] - Average territory productivity reached $2.1 million, representing a 23% increase year-over-year [25] Market Data and Key Metrics Changes - International revenue was $2.2 million, impacted by delayed regulatory clearance for iFuse Torque in Europe [32] - The company expects iFuse Torque to boost revenue growth in Europe starting in 2026 [32] Company Strategy and Development Direction - The company aims to expand its platform of solutions targeting challenging procedures, improving surgical outcomes with lower failure rates [6][8] - Focus on innovation, physician engagement, commercial execution, and operational excellence as key priorities [12] - Plans to launch new products targeting outpatient settings and expand into new addressable markets [21][86] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the demand across the portfolio and the effectiveness of their strategy [44] - The company anticipates continued growth driven by strong physician engagement and product adoption [80] - Guidance for full-year revenue was updated to $195 million to $198 million, implying year-over-year growth of approximately 17% to 18% [36] Other Important Information - The company achieved cash flow breakeven ahead of schedule, indicating potential for consistent positive free cash flow [35] - Leadership changes were announced, with Tony Recoupero retiring and Nicholas Kerr promoted to Chief Commercial Officer [27][28] Q&A Session Summary Question: Guidance on top line growth and assumptions for the second half - Management highlighted strong first-half performance and confidence in continued demand, with a sequential decline expected in Q3 due to seasonality [40][46] Question: Gross margin guidance and pricing pressure - Management discussed maintaining gross margin guidance at 78.5% to 79%, embedding assumptions for ASP pressure while acknowledging potential for better-than-expected outcomes [51][56] Question: Growth of interventional doctors using products - Management noted strong growth from interventional doctors and the potential for further engagement with new product launches [60][62] Question: International market contribution and torque rollout in Europe - Management expressed optimism about the torque product's impact in Europe, with expectations for growth in 2026 [95] Question: Capital deployment priorities - Management indicated a focus on continued investment in R&D and commercial initiatives while maintaining a strong cash position [98]

Summary of Cybone's Conference Call Company Overview - **Company**: Cybone - **Industry**: Medical Technology (Med Tech) - **Focus**: Orthopedic, neuro, spine trauma, and interventional spine products Key Points and Arguments Product Portfolio and Market Expansion - Cybone has a diverse product portfolio targeting three main markets: SI joint dysfunction, pelvic fixation, and trauma-related products [2][3][4] - The total addressable market (TAM) for SI joint dysfunction is estimated at **$2.5 billion**, with approximately **300,000 annual procedures**, and Cybone has only **10% market penetration** [4] - The pelvic fixation market is estimated at **$1 billion**, with about **130,000 procedures** annually [8] - The company launched several products, including iFuse Torque and Granite, to address specific needs in these markets [3][6][10] Growth Metrics - Since the IPO, Cybone has achieved a **CAGR of 20%** in revenue growth, accelerating to **23%** in the last three years [11] - Recent quarterly growth rates reached **25% worldwide** and **27% in the U.S.** [42] - The number of active surgeons using Cybone's products reached **1,400**, with a record addition of **300 new doctors** year-over-year [13][14] Surgeon Engagement and Adoption - The company has seen broad-based growth across various specialties, including interventional, trauma, and orthopedic surgeons [12][14] - There was a **45% increase** in the number of doctors performing multimodality procedures, indicating strong engagement with the expanded product portfolio [14] - Cybone aims to increase density by targeting surgeons who primarily perform lumbar fusion procedures to adopt Granite for SI joint dysfunction [15][16] Future Product Development - Cybone is committed to R&D, spending **10% to 12% of revenue** on clinical evidence and product development [35] - The company plans to launch a third breakthrough device and additional products targeting unmet clinical needs [36][37][39] Financial Performance and Guidance - Gross margins are currently around **80%**, with expectations to stabilize between **76% to 77%** in the long term [50] - The company has adopted a conservative approach to guidance, reflecting macroeconomic uncertainties [43][44] - Cybone's operational leverage is strong, with revenue growth outpacing operating expense growth [52] Market Dynamics and Competitive Landscape - Cybone focuses primarily on surgeons, although there is potential for interventionalists to perform procedures [24][25] - The company has established itself as a preferred partner for interventional spine physicians by offering a comprehensive portfolio and strong clinical data [32][31] Sales Force and Territory Expansion - Cybone plans to expand its sales force to capitalize on growth opportunities, aiming for **100 territories** over the next 12 to 18 months [56][57] - New hires typically take **2 to 2.5 years** to reach full productivity, but this can be accelerated with the right support [58] Additional Important Insights - Cybone's strategy emphasizes identifying unmet clinical needs and developing unique solutions, which has led to high gross margins and a strong financial profile [34] - The company is focused on maintaining a strong relationship with interventionalists while also expanding its reach among surgeons [28][29] This summary encapsulates the key points discussed during the conference call, highlighting Cybone's strategic focus, growth metrics, product development, and market positioning.

Financial Data and Key Metrics Changes - Worldwide revenue for the quarter reached $47.3 million, representing approximately 25% growth compared to the prior year [6][27] - U.S. revenue was $44.8 million, reflecting approximately 27% growth, driven by a 27.3% increase in procedure volume [7][28] - Gross profit was $37.7 million, an increase of $7.8 million or 26.2%, with a gross margin rate of 79.7%, improving by nearly 80 basis points [28] - Net loss narrowed to $6.5 million or $0.15 per diluted share, compared to a net loss of $10.9 million or $0.27 per diluted share in the prior year [29] Business Line Data and Key Metrics Changes - The company experienced broad-based demand for existing technologies and rapid adoption of new solutions launched last year [7][9] - The number of four implant Granite cases grew approximately 69% compared to the prior year period [14] - The introduction of iFuse Torque and iFuse Intra has expanded the market and accelerated procedure volume growth [11][12] Market Data and Key Metrics Changes - The total addressable market has increased to over $3.5 billion, with 25% cumulative procedure volume growth over the last three years [10][11] - The company is targeting nearly 100,000 degenerative procedures annually with the Granite product, which became eligible for transitional pass-through payment starting January 1, 2025 [14] - The pelvic trauma market, with nearly 60,000 potential target procedures annually, represents a $300 million market opportunity [18] Company Strategy and Development Direction - The company focuses on innovation, engagement, commercial execution, and operational excellence as key priorities [10] - A hybrid commercial model combining territory managers and clinical specialists with third-party agents is being utilized to enhance market reach [25] - The company plans to launch new products over the next twelve to eighteen months, including a new SI joint fusion solution and a breakthrough device targeting spine surgery [19][87] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the demand for solutions and the ability to maintain strong revenue growth despite macroeconomic uncertainties [32][56] - The company updated its full-year revenue guidance to a range of $193.5 million to $197.5 million, implying year-over-year growth of approximately 16% to 18% [33][34] - Management highlighted the importance of favorable reimbursement trends and the potential for continued growth in procedure volumes [15][56] Other Important Information - The company exited the quarter with $144.4 million in cash and marketable securities, with a total cash usage of $5.6 million, a 31.7% improvement over the prior year [30] - The company does not anticipate any material impact on gross margins or supply chain from proposed tariffs, as most manufacturing is domestic [31] Q&A Session Summary Question: Contribution from new products and channels to growth - Management noted broad-based growth across all modalities, with strong demand for new products launched in 2024 contributing to accelerating growth [39] Question: Drivers of strong gross margin and future expectations - Management attributed gross margin improvement to better-than-expected average selling prices and supply chain efficiencies, while remaining cautious about potential pressures [42][46] Question: Long-term growth potential and guidance - Management expressed confidence in sustained growth potential beyond 2025, driven by technology leadership and expanding physician engagement [55] Question: Sequential growth expectations and guidance update - Management indicated that while they expect to maintain strong growth, they are being prudent in their guidance due to macroeconomic conditions [64] Question: Operating expenses and growth expectations - Management highlighted that increased operating expenses are linked to R&D investments and sales commissions, but they expect to maintain healthy operating leverage [70]

Financial Data and Key Metrics Changes - Worldwide revenue for Q1 2025 reached $47.3 million, representing approximately 25% growth compared to the prior year [6][26] - U.S. revenue was $44.8 million, reflecting approximately 27% growth, driven by a 27.3% increase in procedure volume [7][26] - Gross profit was $37.7 million, an increase of $7.8 million or 26.2%, with a gross margin rate of 79.7% [27] - Net loss narrowed to $6.5 million or $0.15 per diluted share, compared to a net loss of $10.9 million or $0.27 per diluted share in the prior year [28] - Positive adjusted EBITDA of approximately $5 million compared to an adjusted EBITDA loss of $4 million in Q1 2024 [29] Business Line Data and Key Metrics Changes - The company experienced broad-based demand for existing technologies and rapid adoption of new solutions launched in 2024 [7][39] - The number of physicians performing procedures using the company's products grew by 27%, with over 1,400 U.S. physicians engaged [19] - The number of four implant Granite cases grew approximately 69% compared to the prior year period [13] Market Data and Key Metrics Changes - The total addressable market has increased to over $3.5 billion, with a cumulative procedure volume growth of 25% over the last three years [9][10] - The company is targeting nearly 100,000 degenerative procedures annually with its Granite product, which became eligible for transitional pass-through payment starting January 1, 2025 [13][14] Company Strategy and Development Direction - The company focuses on innovation, engagement, commercial execution, and operational excellence as key priorities [9] - The strategy includes diversifying the product platform with unique yet complementary technologies to expand the target modalities and physician footprint [9][10] - The company aims to reach 100 territories over the next 12 to 15 months, leveraging a hybrid commercial model combining territory managers and third-party agents [24][58] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver strong results over the long term, supported by resilient business trends and favorable reimbursement conditions [8][9] - The updated full-year revenue guidance is between $193.5 million to $197.5 million, implying year-over-year growth of approximately 16% to 18% [32] - Management noted that the company is well-positioned to achieve free cash flow in 2026, with a focus on maintaining operational discipline [30][32] Other Important Information - The company has a strong pipeline of novel technologies under development, with plans to launch new products over the next 12 to 18 months [16][18] - The company does not anticipate any material impact on gross margins or supply chain from proposed tariffs, as most manufacturing is domestic [30][31] Q&A Session Summary Question: Contribution from new products and channels to growth - Management noted broad-based growth and strong demand for current solutions, with impressive adoption of new products launched in 2024 [39] Question: Drivers of gross margin and future expectations - Management highlighted better-than-expected average selling price (ASP) and efficiency initiatives as key drivers of gross margin improvement [42][44] Question: Long-term growth expectations - Management expressed confidence in sustained growth potential, driven by technology leadership and expanding physician engagement [53][56] Question: Expected cadence of new guidance and sequential growth - Management indicated that while they do not think about the business in quarters, they expect to manage seasonality effectively with new product rollouts [66] Question: Operating expenses guidance - Management explained that elevated R&D investments and higher commissions linked to revenue growth are driving the expected increase in operating expenses [70][72] Question: Update on surgeon base and engagement - Management reported a record increase in the physician base, with broad engagement across various specialties [76][78] Question: Updates on reimbursement proposals - Management provided insights on CMS proposals and the potential for increased reimbursement rates, which could accelerate adoption of products [80][81] Question: Traction and adoption of TNT product - Management noted that TNT is seeing rapid adoption and is expected to benefit from upcoming reimbursement changes [97]