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AS

ASENSUS SURGICAL, INC. (ASXC)·Q3 2023 Earnings Summary

Executive Summary

  • Revenue fell 57.5% year over year to $1.09M, roughly flat sequentially; GAAP EPS improved to $(0.07) from $(0.08) YoY, while adjusted EPS improved to $(0.06) from $(0.07) YoY .
  • Management lowered 2023 Senhance program initiation guidance to 8–10 (from 10–12), citing an evolving capital environment; cash runway extended to late Q2 2024 after a $10M July financing .
  • Strategic progress continued: Flex engaged as LUNA manufacturing partner; NVIDIA collaboration to enhance ISU augmented intelligence; preclinical evaluation of LUNA targeted for Q4 completion with design freeze planned in Q1 2024 .
  • Pediatric adoption is a growing wedge: Mayo Clinic’s exclusive pediatric program increased inbound interest; Japan remains a strong region, while Europe saw summer seasonality pressures on volumes .

What Went Well and What Went Wrong

What Went Well

  • Strategic partnerships solidified: finalized manufacturing strategy with Flex for LUNA and collaboration with NVIDIA to advance ISU edge AI (Holoscan), with Google Cloud supporting data architecture .
  • Pediatric momentum: Mayo Clinic’s exclusive pediatric program launched; management noted increasing inbound interest from U.S. children’s hospitals following Mayo and key pediatric meetings .
  • Non-GAAP loss narrowed YoY: adjusted net loss improved to $(15.6)M and adjusted EPS to $(0.06), supported by non-cash warrant liability marks and lower intangible amortization .

Quote: “We anticipate reaching important milestones in the upcoming quarters… our primary objective continues to be the completion of our preclinical evaluation [of LUNA] planned for December this year” — CEO Anthony Fernando .

What Went Wrong

  • Topline contraction: revenue declined to $1.09M from $2.56M YoY, driven by lower product revenue; quarterly procedures grew only 2% YoY with Europe seasonality and softer U.S. volumes .
  • Guidance trimmed: 2023 Senhance program initiations reduced to 8–10 from 10–12 previously due to capital environment constraints .
  • Operating expense pressure: total OpEx increased YoY to $18.5M; gross loss remained elevated at $(1.78)M, reflecting mix and scale challenges .

Financial Results

Income Statement Snapshot (USD Millions except per-share)

MetricQ3 2022Q1 2023Q2 2023Q3 2023
Revenue$2.563 $0.976 $1.081 $1.089
Gross Loss$(1.841) $(1.971) $(1.993) $(1.780)
Total Operating Expenses$17.191 $20.377 $18.870 $18.479
Operating Loss$(19.032) $(22.348) $(20.863) $(20.259)
Net Loss$(18.924) $(22.218) $(20.662) $(18.318)
GAAP EPS$(0.08) $(0.09) $(0.09) $(0.07)
Adjusted Net Loss$(16.942) $(22.001) $(20.345) $(15.560)
Adjusted EPS$(0.07) $(0.09) $(0.09) $(0.06)
Weighted Avg Shares (MM)236.713 238.280 239.570 256.184

Revenue Breakdown by Source (USD Thousands)

CategoryQ3 2022Q2 2023Q3 2023
Product$1,964 $298 $301
Service$335 $289 $295
Lease$264 $494 $493
Total Revenue$2,563 $1,081 $1,089

KPIs and Liquidity

KPIQ3 2022Q2 2023Q3 2023
Procedures (Quarter)N/A>1,000 >760
Procedures YTD GrowthN/A+27% YoY +17% YTD YoY
Senhance Program Initiations (YTD)N/A2 5
Additional Programs Post-Q3N/AN/A2 (1 placed, 1 sold)
Cash & Short-term InvestmentsN/A$40.0 $33.1
Cash RunwayN/ALate Q2 2024 Late Q2 2024

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Senhance Program InitiationsFY 202310–12 (Q2 outlook) 8–10 Lowered
LUNA Integrated System Testing2H 2023Complete in H2 2023 Complete in Q4 2023 Maintained timing window
LUNA Preclinical Evaluation2H 2023Initiate in H2; complete by Q4 Conduct and complete in Q4 2023 Maintained
ISU Manufacturing (Updated Platform)Q4 2023Establish pilot manufacturing H2 2023 Finalize manufacturing partner in Q4 2023 Clarified milestone
LUNA Regulatory Pathway2024–2025Traditional 510(k) anticipated; submissions by end-2024; mid-2025 FDA clearance Traditional 510(k) anticipated; plan unchanged Maintained
Cash RunwayThrough late Q2 2024Extended via $10M financing Maintained Maintained

Earnings Call Themes & Trends

TopicQ1 2023 (Prior-2)Q2 2023 (Prior-1)Q3 2023 (Current)Trend
AI/Technology Initiatives (ISU)CE Mark expansion; ISU digital tools highlighted; awards for ISU Ongoing ISU adoption; conferences showcase augmented intelligence NVIDIA collaboration to enhance ISU; Google Cloud partnership for data; ISU manufacturing ramp Strengthening ecosystem and capabilities
LUNA ProgramUnveiled; 2023 milestones outlined Testing to begin; preclinical by Q4; regulatory plan mid-2025 clearance Integrated testing and preclinical completion targeted by Q4; design freeze Q1 2024 On-track milestones
Market/Regional TrendsJapan growth; pediatric interest rising 27% YoY procedure growth; first U.S. pediatric program Only 2% YoY quarterly growth; Europe summer seasonality; U.S. softer; Japan record procedure year Mixed: strength in Japan, seasonal Europe headwinds
Pediatric AdoptionFDA 510(k) pediatric indication; early U.S. clinical experience First U.S. hospital pediatric exclusive program Mayo Clinic exclusive pediatric use; growing U.S. inbound interest Building momentum
Supply Chain/ManufacturingN/AN/AFlex selected for LUNA manufacturing strategy; ISU partner finalization in Q4 Scaling readiness
Regulatory/Legal510(k) path anticipated for LUNA 510(k) path reiterated; global submissions plan 510(k) confidence reiterated; timeline unchanged Consistent messaging

Management Commentary

  • “We anticipate reaching important milestones… completion of our preclinical evaluation planned for December this year with the full LUNA system.” — Anthony Fernando, CEO .
  • “Based on the recent financing and our current operating plan, we project our cash runway has been extended through late second quarter of 2024.” — Shameze Rampertab, CFO .
  • “Regarding Senhance initiations, we are refining our expectations to initiate 8 to 10 new programs in 2023, down from 10 to 12.” — Anthony Fernando, CEO .
  • “The simple answer is yes [to increased inbound interest]… having a leading hospital like Mayo Clinic validates that thesis.” — Anthony Fernando .

Q&A Highlights

  • Installations/Guidance Confidence: Management affirmed confidence in reaching 8–10 initiations, noting advanced pipeline accounts and near-term closing steps despite compressed timelines .
  • Procedure Mix & Pediatrics: Mix remains led by general surgery, then gynecology and urology; pediatric cases growing in Europe and now in U.S. at Mayo, with increasing weekly case scheduling .
  • Regional Volumes: Quarterly slowdown driven primarily by Europe’s summer holidays; U.S. volumes softer; expecting to drive higher annualized growth in Q4 .
  • Flex Partnership: Manufacturing outsourcing to specialists like Flex to leverage supply chain and cost advantages; two-year dialogue culminated in full-platform engagement .
  • KARL STORZ Discussions: Ongoing, complex multi-domain agreement (visualization, digital elements, global regulatory/commercial scope); update to be provided upon conclusion .

Estimates Context

  • S&P Global consensus estimates for ASXC Q3 2023 were unavailable via our data connection (tool returned missing mapping). As a result, we cannot benchmark reported results against Street expectations in this recap. Values retrieved from S&P Global.
  • Given limited sell-side coverage, investors should focus on sequential trajectories, guidance adjustments, and execution against LUNA/ISU milestones as primary drivers .

Key Takeaways for Investors

  • Revenue contraction and guidance trimming are likely to pressure sentiment near term; watch for confirmation of 8–10 initiations and procedure trajectory in Q4 to stabilize the narrative .
  • The LUNA milestone cadence is the critical medium-term catalyst: completion of integrated testing and preclinical evaluation in Q4, design freeze in Q1 2024, and verification/validation thereafter .
  • Pediatric adoption is a differentiated wedge (Mayo validation) that can drive placements and utilization independent of broader capital cycles; track additional U.S. children’s hospital wins .
  • Strategic partnerships (Flex, NVIDIA, Google) de-risk manufacturing and accelerate AI capabilities; expect increased ISU functionality and clarity on ISU manufacturing partner in Q4 .
  • Liquidity runway into late Q2 2024 reduces near-term financing overhang; near-term execution on initiations, LUNA milestones, and ISU manufacturing will be key to avoiding incremental dilution .
  • Regional mix matters: sustained strength in Japan vs. European seasonality; any rebound in U.S. volumes could improve lease and services revenue stabilization .
  • With Street estimates unavailable, emphasis should be on qualitative milestones and quantitative progress in revenue mix (product recovery) and adjusted loss trajectory improvement .