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SI

SS Innovations International, Inc. (SSII)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 delivered strong top-line growth: revenue rose 192.5% year-over-year to $12.83M, with gross margin at 48.1%; sequentially, revenue increased 28.3% from Q2 2025 while gross margin declined from 59.1% due to mix and cost dynamics .
  • Net loss was $3.72M ($(0.02) diluted EPS), roughly flat vs. $(0.02) in Q3 2024 and wider than Q2’s near-breakeven $(0.00); operating loss narrowed year-over-year on scale benefits despite higher OpEx .
  • Installations scaled sharply: SSi Mantra systems installed in the quarter were 27 (+350% YoY), with cumulative installed base reaching 127 and cumulative surgeries totaling 6,057; utilization continues to expand across geographies and procedures .
  • Regulatory catalysts: human factors validation completed at Johns Hopkins; FDA 510(k) submission targeted for Q4 2025 and CE mark expected 1H 2026, shifting timelines from earlier De Novo and late-2025 expectations—key stock reaction drivers ahead .

What Went Well and What Went Wrong

  • What Went Well

    • Revenue and unit sales acceleration: “Quarterly Revenue Increased 192.5% Year over Year to $12.8 Million Driven by Higher SSi Mantra 3 Unit Sales” .
    • Market positioning and utilization: “rapidly expanding installed base and increasing utilization reflect its cost advantages, ease of use, differentiated features, and compelling surgical outcomes” — Dr. Srivastava .
    • Regulatory progress: successful human factors validation at Johns Hopkins forms “an integral component” of the anticipated Q4 2025 FDA 510(k) submission .
  • What Went Wrong

    • Margin compression: gross margin fell to 48.1% in Q3 2025 vs. 52.8% in Q3 2024 and 59.1% in Q2 2025, indicating mix/production cost effects and scale-up investments .
    • Profitability: net loss was $(3.72)M vs. $(0.26)M in Q2; income tax expense in Q3 further pressured bottom line despite higher gross profit .
    • Cash draw from operations year-to-date: operating cash flow for 9M 2025 was $(17.0)M, reflecting working capital build (inventory and receivables) to support growth .

Financial Results

MetricQ3 2024Q2 2025Q3 2025
Revenue ($USD)$4.386M $10.000M $12.829M
Gross Profit ($USD)$2.317M $5.915M $6.165M
Gross Margin (%)52.8% 59.1% 48.1%
Net Income ($USD)$(3.245)M $(0.257)M $(3.718)M
Diluted EPS ($USD)$(0.02) $(0.00) $(0.02)

Segment revenue breakdown:

CategoryQ3 2024Q3 2025
System sales ($USD)$3.970M $11.705M
Instrument sales ($USD)$0.338M $0.854M
Warranty sales ($USD)$0.059M $0.244M
Lease income ($USD)$0.021M $0.025M
Total revenue ($USD)$4.387M $12.829M

KPIs and operating metrics:

KPIQ3 2024Q2 2025Q3 2025
SSi Mantra installations (units)6 23 27
Cumulative installed base (units)43 105 127
SSi Mantra surgeries (period)650 1,042 1,367
Cumulative surgeries (units)2,149 4,657 6,057
Cash & equivalents (period-end)$11.4M (6/30/25) $5.7M (9/30/25)
Long-term debt$0 $0

Notes:

  • Q3 year-to-date revenue was $28.0M (+123.0% YoY) with gross margin at 47.1%; net loss improved to $(9.7)M vs. $(17.2)M .
  • Q2 had record quarterly revenue previously at $10.0M, with sharp gross margin expansion (59.1%) and near-breakeven EPS .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
U.S. FDA pathway for SSi Mantra2025De Novo submission by end of July 2025 Pivot to 510(k); submit by end of September 2025 (Q2 update) Changed pathway and accelerated timeline
U.S. FDA 510(k) submissionQ4 2025510(k) by end of September 2025 510(k) submission anticipated in Q4 2025 Delayed submission timing
EU CE mark timingLate 2025CE mark “as soon as late 2025” CE mark expected in 1H 2026 Timing pushed out

No financial guidance (revenue, margins, OpEx, tax rate) was provided in Q3 materials .

Earnings Call Themes & Trends

Note: An earnings call transcript for Q3 2025 was not available; themes reflect quarter-to-quarter disclosures.

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q3 2025)Trend
Regulatory pathway (US)Q1: De Novo planned by July 2025 ; Q2: Pivot to 510(k) by end of Sept 2025 Human factors validation completed; 510(k) submission anticipated Q4 2025 Continued progress; timeline extended
EU CE markQ2: CE mark as soon as late 2025 CE mark expected 1H 2026 Timeline pushed out
Installations and utilizationQ1: 15 installs; cumulative base 78 Q2: 23 installs; base 105 Q3: 27 installs; base 127
Telesurgery advancementsQ2: multiple “world firsts,” intercontinental cardiac telesurgery in July Q3: mobile MantraM bus first telesurgery (Sept 9) and pediatric pyeloplasty telesurgery (Sept 16); Tele Surgeon Console first telesurgery (Oct 17) Rapid innovation cadence
AI/mixed reality & trainingQ3 investor materials highlight mixed reality and AI-enabled training (SSi Maya, Guru XR) Tele-proctoring and visualization enhancements showcased Expanding capabilities
Market focus (India leadership)Q1/Q2: scaling in India and abroad Reinforced leadership in India; expanding approvals to seven countries Geographic expansion

Management Commentary

  • “We delivered strong revenue growth in the third quarter of 2025, driven by higher unit sales of our advanced, cost-effective SSi Mantra 3… The SSi Mantra’s rapidly expanding installed base and increasing utilization reflect its cost advantages, ease of use, differentiated features, and compelling surgical outcomes.” — Dr. Sudhir Srivastava, Chairman & CEO .
  • “We successfully completed a human factors validation study at Johns Hopkins Hospital… an integral component of our upcoming 510(k)… which we anticipate submitting to [the] FDA in the fourth quarter of 2025… We also continue along the pathway towards a European Union CE marking certification in the first half of 2026.” — Dr. Srivastava .
  • On TSC: “We believe that the SSi Mantra Tele Surgeon Console will offer significant advantages for telesurgery applications… enabling the provision of surgical expertise from the office of any physician… As long as connectivity is available, we believe that telesurgery and physician expertise can be extended from anywhere using the TSC.” — Dr. Srivastava .
  • On pivot to 510(k): “We pivoted from filing a De Novo request… to pursuing the 510(k) regulatory pathway, which offers potential speed and cost advantages… human factors validation study… will be an integral part of our 510(k) premarket notification.” — Dr. Srivastava .

Q&A Highlights

  • No Q3 2025 earnings call transcript was available; therefore, Q&A themes and clarifications cannot be assessed for this quarter [Search returned none].

Estimates Context

  • S&P Global consensus coverage appears unavailable for SSII this quarter. We were unable to retrieve consensus for Primary EPS or Revenue; the data source only returned actuals with no consensus means or estimate counts for Q3 2025, Q2 2025, or Q1 2025.
  • Result vs. estimates: Not applicable due to lack of consensus; investors should assume limited sell-side coverage at this stage [GetEstimates returned no consensus values; values retrieved from S&P Global]*.
MetricQ3 2025 Consensus (S&P Global)ActualSurprise
Revenue ($USD)N/A*$12.829M N/A
Primary EPS ($USD)N/A*$(0.02) N/A

*Values retrieved from S&P Global.

Key Takeaways for Investors

  • Unit-driven growth continues: System sales were $11.7M in Q3 (+195% YoY), underscoring robust demand and installed-base expansion; watch quarterly installations and instrument pull-through as utilization scales .
  • Margin volatility likely near term: Gross margin stepped down to 48.1% from 59.1% in Q2; mix, production scaling, and pricing dynamics are key variables to monitor into Q4 and 2026 .
  • Profitability inflection still ahead: Net loss widened sequentially to $(3.72)M from near breakeven; sustained growth and operating leverage, plus tax dynamics, will be critical to achieving consistent profitability .
  • Regulatory milestones are central catalysts: Q4 2025 FDA 510(k) submission and 1H 2026 CE mark expectation are pivotal; any timeline acceleration or delays likely drive stock reaction .
  • Telesurgery differentiation: First telesurgeries via mobile unit and Tele Surgeon Console expand addressable scenarios and hospital network strategies; underscores technology moat and potential for distributed expert access .
  • Coverage may be thin: Lack of consensus estimates limits “beat/miss” trading catalysts; company-led milestones and installation/surgery KPIs likely drive narrative and price action near term [GetEstimates returned no consensus; values retrieved from S&P Global]*.
  • Liquidity and working capital: Cash was $5.7M at quarter end (excl. restricted), and operating cash flow year-to-date was $(17.0)M; inventory and receivables growth reflect scale—monitor financing and cash generation against growth plans .