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OI

Orgenesis Inc. (ORGS)·Q4 2021 Earnings Summary

Executive Summary

  • Reported full-year revenue of $35.502M, up 364% year-over-year; management highlighted strong visibility with customer commitments “in excess of $30M” for 2022 and “over $50–55M” for 2023 .
  • Operational progress on point‑of‑care (POCare) scale-up: first OMPUL placed in Spain (Niño Jesús), expanded JHU collaboration to establish a new POCare Center (supported by a $5M Maryland grant), and Greek JV approved for up to €32M in government funding .
  • Balance sheet tightness: cash and equivalents fell to $5.473M at year end; CFO and CEO emphasized grants, out-licensing revenues, and targeted 2022 cash‑flow breakeven, but noted openness to strategic capital options if needed .
  • Prior quarters showed strong growth momentum (Q2 revenue $10.5M; Q3 revenue $8.7M), but Q4 detail was not disclosed; no usable Wall Street consensus (SPGI) estimates were available for Q4 .

What Went Well and What Went Wrong

What Went Well

  • “Revenues have increased more than four‑fold to $35.5 million for 2021” with multi‑year customer revenue commitments (>$30M for 2022; >$55M for 2023), providing forward visibility .
  • OMPUL deployment and network expansion: “first OMPUL in Spain” (Niño Jesús), expanded JHU collaboration to a new POCare Center funded “in part by a $5 million grant,” and JV in Greece granted “up to €32 million” with fast‑track status .
  • Management confidence on breakeven: “we should be okay with breakeven” in 2022 as heavy development is completed and remaining R&D covered by grants .

What Went Wrong

  • Liquidity and leverage: year‑end cash fell to $5.473M; current maturities of convertible loans at $5.885M highlight near‑term obligations .
  • Profitability still negative: operating loss $16.800M; net loss from continuing operations $18.059M despite revenue growth .
  • Limited Q4 granularity and no formal guidance framework: quarterly (Q4) revenue/EPS not disclosed in the 8‑K; management reiterated they do not provide quarterly guidance .

Financial Results

YoY summary

MetricFY 2020FY 2021
Total Revenues ($USD Millions)$7.652 $35.502
Operating Loss ($USD Millions)$95.785 $16.800
Net Loss from Continuing Operations ($USD Millions)$95.127 $18.059
Basic & Diluted from Continuing Ops ($/share)$4.46 $0.74
Cash and Cash Equivalents ($USD Millions)$44.923 $5.473

Quarterly revenue trend (limited disclosed detail)

MetricQ2 2021Q3 2021Q4 2021
Revenues ($USD Millions)$10.5 $8.7 N/A (not disclosed in 8‑K)

Revenue mix (FY 2021)

Revenue StreamFY 2020 ($USD Millions)FY 2021 ($USD Millions)
POC & Hospital Services (Mainly POC)$6.068 $32.819
Cell Process Development Services$1.584 $2.683
Total$7.652 $35.502

Selected KPIs and balance items

KPI / MetricPeriodValue
Customer revenue commitments2022>$30M
Customer revenue commitments2023>$50–55M
Accounts Receivable, Net12/31/2021$15.245M
AR past due (approximate)3/31/2022 call< $3M
Cash & Equivalents12/31/2021$5.473M
Current maturities of convertible loans12/31/2021$5.885M
First OMPUL placementQ4 2021Spain (Niño Jesús)
Greek JV grantQ4 2021Up to €32M (fast‑track)
JHU POCare Center supportQ4 2021$5M State grant

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Revenue commitmentsFY 2022None disclosed >$30M New
Revenue commitmentsFY 2023None disclosed >$50–55M New
Cash‑flow breakeven targetFY 2022None disclosed Breakeven targeted (budgeted) New

Earnings Call Themes & Trends

TopicQ2 2021 (Previous Mentions)Q3 2021 (Previous Mentions)Q4 2021 (Current Period)Trend
OMPUL rollout & validationStandardization, validation focus; network build‑out OMPULization process; batches underway; production capacity model clarified First OMPUL placed in Spain; broader deployment plans Accelerating deployment
Revenue momentum & contractsStrong YoY growth; long‑term MSAs underpin visibility +400% YoY Q3; MSAs typically 2–3 years 2022/2023 commitments disclosed; breakeven targeted Sustained growth visibility
Regulatory/hospital exemption——EU/Asia hospital exemption discussed as faster market path vs IND Regulatory optionality rising
Grants & regional supportAustralia/JV expansion; government interest Greek JV fast‑track noted $5M Maryland grant; €32M Greek grant; more grants anticipated Increasing public support
KYSLECEL commercializationWorking on automation/OMPULization; EU pathway exploration US approval acknowledged; scaling limits; EU/Asia expansion work Market potential “>$500M” in US; EU GMP alignment and site plans Gradual capacity build

Management Commentary

  • “We have already received commitments from customers for future revenues in excess of $30 million for 2022 and $55 million for 2023.”
  • “We placed our first OMPUL in Spain at Hospital Infantil Universitario Niño Jesús in Madrid… process TILs and MSCs.”
  • “Construction of the new point of care center will be funded in part by a $5 million grant from the State of Maryland.”
  • “I think we should be okay with breakeven… heavy development is finished and remaining R&D is covered by grants.”

Q&A Highlights

  • KYSLECEL expansion: management is “still in discussion” on EU clinical sites; focus on regulatory alignment and capacity expansion .
  • Liquidity runway: expenses “declining,” grants and out‑licensing to support operations; targeting cash‑flow breakeven; exploring strategic financing if needed .
  • Accounts receivable: 90‑day terms; strong collectability history; “past dues… less than about $3 million” expected to be collected short‑term .
  • Revenue commitments clarification: 2022/2023 commitments are services revenue “in addition” to 2021; sticky relationships as partners secure capacity .

Estimates Context

  • Wall Street consensus (SPGI) EPS and revenue estimates for Q4 2021 were unavailable due to data access limits (S&P Global daily request cap exceeded). As a result, comparisons vs consensus could not be performed [GetEstimates error].

Key Takeaways for Investors

  • High visibility topline with disclosed customer commitments for 2022/2023 and multi‑year MSAs supports sustained services revenue momentum; breakeven targeted for 2022 on grants and mix shift to batch production .
  • Execution on decentralized manufacturing is advancing (OMPUL Spain, JHU center, Greek fast‑track grant), positioning Orgenesis as an enabling infrastructure player for autologous CGTs .
  • Liquidity is the near‑term watch‑item: cash of $5.473M and current convertible maturities of $5.885M necessitate disciplined working capital management and potential strategic financing if breakeven slips .
  • KYSLECEL capacity remains the gating factor; EU GMP alignment and OMPULization could unlock broader adoption and diversify revenue beyond services .
  • Regulatory pathways (EU hospital exemption) may accelerate therapy revenue timing in select regions—monitor pipeline candidates leveraging this track .
  • Investor relations emphasis and validation milestones (first commercial batches, additional OMPUL placements) are potential stock catalysts as the model demonstrates scale .
  • Without formal quarterly guidance and absent consensus estimates, focus on disclosed commitments, AR collections, grant inflows, and site activations to track execution vs breakeven plan .

All statements and data above are sourced from Orgenesis’ Q4 2021 8‑K press release and exhibits, and earnings call transcripts: .