Executive Summary

Revenue increased 177% year over year to $7.3M, with gross profit up 198% to $3.0M; however, net loss widened to $8.3M and diluted EPS was a loss of $0.55 as R&D and SG&A stepped up, including JV-related stock compensation .
Management emphasized CDMO capacity expansion (new Gosselies, Belgium site targeting commercial stage customers and a 30,000 sq ft Houston facility) and accelerating Point-of-Care (POCare) partnerships across Japan, Europe, and U.S. academia as strategic growth catalysts .
Balance sheet liquidity remained solid with $14.4M cash and $21.4M total equity at quarter-end; operating lease liabilities increased under ASC 842 adoption, reflecting expanded facilities footprint .
No formal quantitative guidance was provided; absent an earnings call transcript, investor focus is likely on execution of CDMO capacity builds, JV commercialization milestones, and sustained demand in cell/gene therapy services .
Wall Street EPS/revenue consensus from S&P Global for Q1 2019 was unavailable; estimate comparisons are not possible (values would normally be retrieved from S&P Global).*

What Went Well and What Went Wrong

What Went Well

Record quarterly revenue of $7.3M (+177% YoY) driven by expanding CDMO services; gross profit reached $3.0M (+198% YoY), showcasing strong demand and pricing within cell/gene therapy services .
Strategic expansion: new commercial-stage CDMO site in Gosselies, Belgium and a 30,000 sq ft manufacturing facility in Houston to deepen North American presence and serve commercial customers .
POCare momentum: agreements with HekaBio (Japan), TheraCell (Europe), Columbia University (oncology vaccine platform), ExcellaBio (exosomes), and Digilab (3D bioprinting) broaden future revenue optionality and regional access .

“‘The revenue increase…is a direct result of the expanding capacity of our CDMO business to meet the growing demand by providing high quality services to our client base’” — Vered Caplan, CEO .

What Went Wrong

Net loss widened to $8.3M vs. $5.6M prior-year, driven by higher R&D ($5.2M) and SG&A ($5.6M), including $2.641M stock-based compensation tied to the First Choice JV, compressing operating results despite revenue growth .
Operating loss increased to $8.3M vs. $3.2M prior-year, reflecting step-up investments, lease impacts from ASC 842 adoption, and limited POC revenue contribution (segment still pre-commercial) .
No quantitative guidance; lack of an earnings call transcript limits clarity on near-term margin trajectory and commercialization timelines for POC assets .

Financial Results

Income Statement Comparison

Metric	Three months ended Feb 28, 2018	Three months ended Aug 31, 2018	One month ended Dec 31, 2018	Three months ended Mar 31, 2019
Revenue ($USD Millions)	$2.636	$6.230	$1.852	$7.301
Gross Profit ($USD Millions)	$0.992	$2.849	$0.631	$2.957
Gross Profit Margin %	37.6% (0.992/2.636)	45.7% (2.849/6.230)	34.1% (0.631/1.852)	40.5% (2.957/7.301)
Operating Loss ($USD Millions)	$3.238	$0.645	$2.963	$8.273
Net Loss Attributable to Orgenesis ($USD Millions)	$5.611	$5.070	$2.744	$8.311
Diluted EPS ($USD)	$(0.52)	$(0.35)	$(0.19)	$(0.55)

Segment Revenue Breakdown (CDMO vs. Eliminations/POC)

Metric	Three months ended Feb 28, 2018	Three months ended Aug 31, 2018	One month ended Dec 31, 2018	Three months ended Mar 31, 2019
CDMO Revenue ($USD Thousands)	$3,181	$8,092	$2,377	$8,573
POC/Corporate Eliminations ($USD Thousands)	$(545)	$(1,945)	$(525)	$(1,272)
Consolidated Revenue ($USD Thousands)	$2,636	$6,230	$1,852	$7,301

KPIs and Balance Sheet Snapshot

Metric	Nov 30, 2018	Dec 31, 2018	Mar 31, 2019
Cash and Cash Equivalents ($USD Thousands)	$16,064	$14,612	$14,361
Accounts Receivable, net ($USD Thousands)	$4,151	$3,226	$5,975
Inventory ($USD Thousands)	$1,736	$1,660	$1,992
Contract Liabilities ($USD Thousands)	$5,317	$5,175	$7,533
Operating Lease ROU Assets ($USD Thousands)	—	—	$14,354
Total Equity ($USD Thousands)	$28,649	$26,750	$21,401
Cash Flow from Operations ($USD Thousands)	—	$(1,077)	$(4,511)

Estimates vs. Actuals

Wall Street consensus EPS and revenue estimates for Q1 2019 were unavailable via S&P Global; comparisons to consensus could not be performed. Values would normally be retrieved from S&P Global.*

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Revenue	FY/Q1 2019	Not provided	Not provided	Maintained – no formal guidance
Margins	FY/Q1 2019	Not provided	Not provided	Maintained – no formal guidance
OpEx	FY/Q1 2019	Not provided	Not provided	Maintained – no formal guidance
Tax rate	FY/Q1 2019	Not provided	Not provided	Maintained – no formal guidance
Segment specifics	FY/Q1 2019	Not provided	Not provided	Maintained – no formal guidance

Earnings Call Themes & Trends

(No Q1 2019 earnings call transcript was available; themes reflect press release and 10‑Q.)

Topic	Previous Mentions (Q3 2018, Dec 2018)	Current Period (Q1 2019)	Trend
CDMO capacity expansion	Belgium late-stage/commercial unit expansion; funding from SFPI; Great Point Partners investment to scale CDMO	New Gosselies, Belgium site targeting commercial-stage customers; 30,000 sq ft Houston facility in buildout	Accelerating buildout
POCare partnerships & licensing	JVs: HekaBio (Japan), India JV; Ben-Gurion licensing; early-stage POC revenue minimal	Agreements with HekaBio, TheraCell, Columbia University, ExcellaBio, Digilab; platform alignment for autologous therapies	Broader geographic and modality coverage
R&D execution & spend	R&D ramp for new therapeutics; DGO6 project; JV and collaboration costs	R&D $5.2M; $2.641M stock compensation to First Choice JV; additional JV/MSA activity	Elevated near-term investment
Accounting/leases	Pre-adoption; revenue growth from CDMO; ASC 606 impact noted	ASC 606 adopted (immaterial cumulative effect); ASC 842 adopted—ROU assets $14.354M and lease liabilities up	Structural balance sheet changes
Geographic/customer concentration	Majority revenues in Belgium; top customers concentration disclosed	Continued Belgium-centric operations; large contract liabilities backing future services	Stable core geography

Management Commentary

“We achieved strong year-over-year revenue growth of 177%, with revenue increasing to a record $7.3 million for the first quarter of 2019… establishing a new, state-of-the-art production site within the Gosselies Biopark in Belgium… new 30,000 square foot manufacturing facility in Houston, Texas” — Vered Caplan, CEO .
“We have aligned ourselves with key regional partners… to enable our autologous cell therapy platform… [POCare] is driving further value… through collaboration and out licensing agreements” — Vered Caplan .
Business model overview clarifies CDMO via Masthercell (Belgium, Israel, Korea, U.S.) and POCare platform advancing ATMPs through regional JVs and licensing .

Q&A Highlights

No Q1 2019 earnings call transcript was available in our document search; thus, there were no disclosed analyst Q&A themes, guidance clarifications, or tone assessments [ListDocuments earnings-call-transcript: none].

Estimates Context

S&P Global consensus EPS and revenue estimates for Q1 2019 were unavailable; comparison to estimates cannot be provided. If available, we would anchor to S&P Global consensus for beat/miss analysis.*

Key Takeaways for Investors

Demand backdrop is robust: CDMO revenue rose to $8.573M before eliminations in Q1, with consolidated revenue at $7.301M, reflecting sustained cell/gene therapy service growth .
Profitability near term is pressured by deliberate investment: operating loss widened to $8.273M and net loss to $8.311M amid higher R&D and SG&A, including JV-related stock compensation, suggesting a build phase ahead of scale .
Capacity expansions (Belgium commercial site, Houston facility) are tangible catalysts to onboard commercial-stage customers and increase utilization, potentially driving operating leverage over time .
Contract liabilities climbed to $7.533M, indicating booked but not yet recognized work that may underpin future revenue conversion and cash collection .
Liquidity provides runway: $14.4M cash and access to strategic funding (e.g., Great Point Partners contingent payments) support execution, though continued losses in POC may necessitate disciplined capital deployment .
Watch execution on POCare JVs (HekaBio, TheraCell, Columbia) for milestones that could transition POC from pre-revenue to commercialization, diversifying beyond CDMO .
Absence of formal guidance and no call transcript increases reliance on sequential disclosures; investors should monitor Q2/Q3 updates for margin trajectory, capacity timing, and customer mix .

*Estimates unavailable via S&P Global; values would normally be retrieved from S&P Global.

Orgenesis Inc. (ORGS)·Q1 2019 Earnings Summary