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MG

Motus GI Holdings, Inc. (MOTS)·Q2 2023 Earnings Summary

Executive Summary

  • Q2 revenue was $0.113M, down 39% year over year, while net loss narrowed to $3.0M ($0.40/share) from $5.1M ($1.86/share) on aggressive cost cuts; operating loss fell to $2.68M vs $4.36M in Q1, materially improving quarterly burn .
  • Management reiterated plans to submit special 510(k)s for Pure-Vu Gen 4 Gastro and Colon in Q4’23 and highlighted expected ~50% cost-of-goods reductions for Gen 4, maintaining prior timelines and efficiency thesis .
  • Commercial and clinical catalysts advanced: Banner Desert Medical Center purchase/implementation, Israel AMAR approval, and favorable real‑world/clinical data (Minneapolis VA IBP reduction; IECED Gen 4 Gastro evaluation) .
  • Cash and equivalents were $8.5M at 6/30 with ~ $10.6M Kreos debt outstanding; company expects runway through Q1’24 and is exploring strategic and financing alternatives—liquidity/regulatory milestones are likely the next stock catalysts .
  • S&P Global Wall Street consensus estimates were unavailable for MOTS this quarter; beat/miss analysis vs consensus cannot be assessed (estimates would be sourced from S&P Global if available).

What Went Well and What Went Wrong

What Went Well

  • Regulatory execution on track: “on track to submit planned special 510(k) for Pure‑Vu Gen 4 Gastro and Colon to the FDA in Q4 2023,” with design improvements expected to halve cost of goods and reduce training requirements .
  • Early commercial traction and access: Banner Desert Medical Center purchased and began implementing Pure‑Vu; Israel AMAR approval enables commercial sales, expanding international footprint .
  • Positive clinical/real‑world validation: Minneapolis VA study showed a 33% reduction in incomplete bowel prep (IBP) and high success/cleanliness improvements; IECED evaluation indicated strong usability and efficiency for Gen 4 Gastro, supporting the value proposition .

Quote: “The Pure‑Vu Gen 4 Gastro and Colon will offer…a reduction in the cost‑of‑goods of approximately 50%…We are working with well‑respected research hospitals…to generate preclinical and clinical data that show the value this system offers patients and hospitals.” — CEO Mark Pomeranz .

What Went Wrong

  • Top-line softness: Q2 revenue declined to $0.113M from $0.185M in Q2’22 as sales were primarily disposables with limited workstation sales .
  • Capital structure/continuity risks: Total shareholders’ equity turned negative in 1H’23 (deficiency of $0.963M at 6/30) and the company received a Nasdaq minimum bid price deficiency notice in April; liquidity remains dependent on financing and milestones .
  • Ongoing cash burn despite progress: Net cash used in operating activities and capex was $2.6M in Q2 (improved but still significant), with ~$10.6M Kreos facility outstanding; H1 restructuring incurred ~$1.5M of non‑recurring charges .

Financial Results

MetricQ4 2022Q1 2023Q2 2023
Revenue ($USD Millions)$0.109 $0.056 $0.113
Loss from Operations ($USD Millions)$(4.028) $(4.359) $(2.682)
Net Loss ($USD Millions)$(3.683) $(4.386) $(2.997)
Diluted EPS ($USD)$(0.79) $(0.92) $(0.40)
Total Costs & Expenses ($USD Millions)$4.137 $4.415 $2.795
Net Cash Used in Ops + Capex ($USD Millions)$4.0 $4.8 $2.6
Cash & Equivalents ($USD Millions, period end)$14.0 $8.6 $8.5

KPIs and Balance Sheet Highlights

KPI / Balance ItemQ4 2022Q1 2023Q2 2023
Kreos Capital Debt Outstanding (approx., $USD Millions)~$11.5 ~$10.6 ~$10.6
Shareholders’ Equity ($USD Millions)$2.977 $(1.085) $(0.963)

Notes: Operating loss margin improved sequentially (Op loss of $2.68M vs revenue $0.113M) alongside lower total costs/expenses, reflecting restructuring and opex controls .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Pure‑Vu Gen 4 Gastro special 510(k) submissionQ4 2023On track for 2H/Q4 2023 submission On track for Q4 2023 submission Maintained
Pure‑Vu Gen 4 Colon special 510(k) submissionQ4 2023Gen 4 platform enhancements planned with similar timing On track for Q4 2023 special 510(k) Maintained
Operating expense cash burn2023>50% reduction expected; ~$1.5M non‑recurring charges in H1’23 >50% reduction expected; ~$1.5M non‑recurring charges in H1’23 Maintained
Liquidity runwayThrough Q1 2024Not previously quantified in Q1 releaseCash sufficient through Q1 2024 New disclosure
Strategic/financing alternativesOngoingProcess initiated (Jan–Mar 2023) Continues to explore alternatives Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4’22)Previous Mentions (Q1’23)Current Period (Q2’23)Trend
Regulatory: Gen 4 Gastro/ColonTargeting 2H’23 FDA submission; ~50% COGS reduction On track for Q4’23 510(k) submissions On track for Q4’23 special 510(k) for both Steady execution
Cost controlsRestructuring began Jan’23 to cut quarterly opex ~35% Two rounds of cuts; >50% cash burn reduction expected >50% cash burn reduction expected; $1.5M H1 charges Maintained discipline
Commercial traction (US)Supporting installed base; pipeline in health systems Focus on VA positioning; adding new pipeline Banner Desert system purchase/implementation Incremental progress
International expansionAMAR approval for Israel sales Expanding reach
Clinical/real‑world dataDDW: 33% IBP reduction at MVA IECED Gen 4 Gastro evaluation; continued positive MVA narrative Strengthening validation
Liquidity/financing$14.0M cash YE’22; debt $11.5M $8.6M cash; ~$10.6M debt $8.5M cash; ~$10.6M debt; runway through Q1’24 Tight but managed
Listing statusNasdaq bid-price deficiency notice (Mar 31) Ongoing compliance risk

Management Commentary

  • “We remain on track with the planned submission of a special 510(k) to the FDA in the coming months…Pure‑Vu Gen 4 Gastro and Colon will offer…a reduction in the cost‑of‑goods of approximately 50%.” — CEO Mark Pomeranz .
  • “We are working with…research hospitals…to generate preclinical and clinical data…This includes Dr. Carlos Robles‑Medranda…who…helped highlight the Pure‑Vu Gen 4 Gastro and Colon system during the…IECED Live Endoscopy Course 2023.” — CEO Mark Pomeranz .
  • On clinical value: “The data…offer an example of the real‑world impact that the Pure‑Vu EVS can have…reducing canceled and poor quality procedures, leading to improved resource utilization and patient experience.” — CEO Mark Pomeranz (DDW 2023) .

Q&A Highlights

  • A Q2’23 earnings call transcript was not available in our document set; no Q&A themes could be extracted for this quarter (we searched earnings‑call‑transcript/other‑transcript and found none).

Estimates Context

  • Wall Street consensus estimates from S&P Global were unavailable for MOTS for Q2’23; as a result, we cannot assess revenue/EPS beats or misses against consensus this quarter. If/when available, comparisons will be anchored to S&P Global.

Key Takeaways for Investors

  • Liquidity bridge to pivotal catalysts: ~$8.5M cash at 6/30 and runway through Q1’24 should carry MOTS to the Q4’23 Gen 4 510(k) submissions; successful clearance could be a material catalyst for platform adoption .
  • Sequential operating improvement: Operating loss and total expenses declined meaningfully QoQ as restructuring benefits materialize; sustaining this trajectory is key to extending runway absent additional financing .
  • Commercial validation building: Banner Desert implementation, Israel AMAR approval, and supportive data (MVA, IECED) bolster the case for broader uptake post‑Gen 4 clearance .
  • Capital and listing risks persist: Negative shareholders’ equity, Nasdaq bid price notice, and ~$10.6M of debt underscore the importance of near‑term milestones or strategic alternatives to support continuity .
  • Near‑term trading setup: Newsflow on FDA 510(k) filings/clearances, additional hospital wins, and any updates on strategic processes are likely stock drivers into and through Q4’23 .
  • Longer‑term thesis: If Gen 4 delivers materially lower COGS and easier training for upper/lower GI use, the platform could expand indications and improve unit economics—critical to transition from early traction to scalable commercialization .

Appendix: Additional Relevant Q2’23 Period Items

  • Private placement: Up to ~$3.5M of shares and warrants agreed in May 2023 to support working capital needs .
  • Banner system‑wide approval and first installation noted as part of system‑level rollout strategy .

All citations:

  • Q2’23 8‑K Press Release and exhibits
  • Q1’23 8‑K Press Release and exhibits
  • Q4’22/FY’22 8‑K Press Release and exhibits
  • DDW 2023 study press 8‑K
  • Gen 4 Gastro IECED evaluation 8‑K
  • Private placement/agreements 8‑K (and related exhibits )
  • Nasdaq bid‑price deficiency 8‑K