Aurion Biotech Financial Model

• Product: Corneal Endothelial Cell Therapy (CCT) - proprietary cultured corneal endothelial cells injected into the patient's anterior chamber in a ~10-minute outpatient procedure.
• Mechanism: Diseased endothelium removed; donor cells injected in suspension; cells self-align on Descemet's membrane with a ROCK inhibitor adjuvant; patient recovers prone.
• Manufacturing leverage: One donor cornea yields cells sufficient for 100+ treatments.
• Key advantages over standard of care (DMEK/DSAEK):
• Eliminates donor cornea supply constraint (1:1 ratio → 1:100+).
• Simpler, faster procedure (~10 min vs. multi-hour surgery).
• No skilled surgeon requirement for tissue dissection.
• Medicare Part B injectable reimbursement pathway.
• Brand name: Vyznova (trademark noted in disclaimer).

• Total prevalence: 16 million people in US/EU/Japan with corneal endothelial disease (4% of population age 40+).
• Annual incidence: 500,000 new cases per year.
• Annual treated: <70,000 procedures/year (endothelial keratoplasties).
• TAM: $4.75 billion - based on 475,000 eyes × $10,000 per procedure.
• Payor reimbursement cited: $20,000–$25,000 per procedure (Syneos study).
• TAM calculation appears to use the annual incidence of 500,000 minus ~25,000 estimated untreatable ≈ 475k eyes; deck uses $10k as conservative procedure price vs. $20-25k reimbursement figure.
• SAM / SOM: Not explicitly stated. Current addressable (treated pool) = ~70,000/year → ~$700M at $10k ASP.
• Additional platform indications mentioned: glaucoma, ocular surface disease, AMD. - no market sizing provided for these.

• Pricing: Procedure-level pricing per eye treated. Payor reimbursement $20,000–$25,000/procedure (Syneos study). Company targets a "premium to current standard of care."
• TAM assumption: $10,000/procedure used in TAM model (conservative vs. reimbursement).
• Channel: Sold to ophthalmologists/surgical centers as injectable therapy. Positioned as Medicare Part B injectable.
• Geographic sequencing: Japan first (NDA 2H 2022), then US (IND 2H 2022 → Phase 3 → BLA).
• Manufacturing: CDMO model (Sumitomo in Japan, Cognate/Charles River in US). - implies COGS driven by CDMO contract costs.
• Revenue recognition: Per-procedure / per-vial basis once approved. No recurring subscription or device revenue model mentioned.
• No pricing deck or P&L provided. All unit economics derived from reimbursement figures.

• Patients treated to date: 100+
• Japan Phase 2/3 (exploratory) - First 11 patients, ages 49–82:
• Mean Corneal Thickness: Baseline 743 µm → 6 mo 549 µm → 2 yr 552 µm → 5 yr 555 µm (healthy range: 540–555 µm)
• Mean Visual Acuity: Baseline 20/220 → 6 mo 20/33 → 2 yr 20/23 → 5 yr 20/30 (healthy range: 20/20–20/40)
• Safety: No serious adverse events at 6 months, 2 years, 5 years
• IOTA Trial (El Salvador, Nov 2020) - 4 sample patients at 12 months post-op:
• Patient 1: BCVA 20/2000 pre-op → 20/20 at 12mo; CCT 669 µm → 535 µm
• Patient 2: BCVA 20/500 → 20/80; CCT 800 → 582 µm
• Patient 3: BCVA 20/100 → 20/40; CCT 669 → 535 µm
• Patient 4: BCVA 20/50 → 20/20; CCT 875 → 559 µm
• Prior funding: $37M Series B raised 2018–19.
• Regulatory milestones: Japan NDA submission 2H 2022; US IND submission 2H 2022.

• Revenue per procedure: $10,000 (TAM model) to $20,000–$25,000 (Syneos payor reimbursement).
• Manufacturing cost advantage implied: 1 donor → 100+ treatments dramatically reduces input cost per vial vs. conventional DMEK tissue. - no dollar figures provided.

• Current standard of care competitors: DMEK and DSAEK (donor cornea transplant surgeries).
• Competitive positioning: Superior to SoC on supply scalability, procedure simplicity, and economics.
• No direct cell therapy competitors named in deck.
• IP / moat:
• Proprietary cell replication/culture technology.
• IP acquired via CorneaGen spin-out.
• Cell therapy IP licensed from Prof. Shigeru Kinoshita (inventor; KPUM/Kyoto Prefecture Univ. of Medicine; published NEJM 2018).
• ROCK inhibitor-based cell propagation technology appears central to the moat.
• Clinical data moat: 5-year long-term follow-up data published in NEJM and Ophthalmology.
• No direct competitive landscape / comp table shown in deck.

• CEO: Greg Kunst (ex-Glaukos, Alcon/Novartis, Kinetic Concepts, Herbert Eye Institute UCI).
• CFO: David Rostov (ex-Donuts Inc., Avalara, Lighthouse Global, InfoSpace, drugstore.com).
• CSO: Arnaud Lacoste, MBA PhD (ex-Novartis group head cell & gene therapy, Rockefeller University).
• CRO: Daniela Drago, MS PhD (ex-Biogen, NDA Partners, GWU School of Medicine, Bausch & Lomb).
• VP Clinical Dev't: Eris Jordan, OD (ex-Bascom Palmer Eye Institute, CorneaGen, AcuFocus).
• VP Manufacturing: Tim Largen (ex-Lykan Bioservices, Dendreon, Caladrius, Argos Therapeutics).
• VP Marketing: Judith McGarry (ex-Adaptive Biotechnologies, Hyperion Therapeutics).
• Existing investors: Flying-L-Partners, Falcon Vision (KKR), Petrichor, Visionary Ventures.
• Prior funding: $37M Series B (2018–19).
• Use of funds implied by milestones: Japan NDA submission, US IND submission (both 2H 2022), US Phase 3 trial.

Archetype + why: Clinical-stage biotech R&D burn + probability-adjusted commercialization model (similar to pharma NPV/rNPV framework). This is a pre-revenue therapy company with binary regulatory events (Japan NDA, US IND → Phase 3 → BLA). The right model is a two-phase structure: (1) R&D/cash-burn runway through regulatory approval, then (2) a procedure-volume revenue ramp upon commercialization. Given procedure-based revenue, a units-sold P&L model applies once commercial.

Not a SaaS, DTC, or marketplace model. Not an M&A/SPAC deck.

Forecast horizon & granularity:

• Phase 1 (R&D): Annual, 2022–2025 (Japan approval ~2023–24 est.; US Phase 3 likely 2024–2026+).
• Phase 2 (Commercial): Annual, 2025–2030.
• Total: 8-year model (2022–2030), annual granularity. Monthly burn tracker for R&D phase optional.

Key drivers & assumptions:

*Market & volume drivers:*

• Annual addressable procedures (US): 70,000 currently treated; growth rate
• Market penetration - US:
• Japan launch timing:; US launch:
• Japan market size:
• Eyes per patient:

*Pricing:*

• ASP (US):
• ASP (Japan):
• Price escalation:

*COGS / gross margin:*

• COGS per vial:
• Target gross margin:

*R&D / operating expense:*

• Burn rate pre-commercial:
• Headcount growth:
• SG&A (commercial phase):

*Balance sheet / funding:*

• Implied next funding round:

Scenarios (Base / Bull / Bear - which variables flex):

• Base: Japan approval 2024, US approval 2027; 15% US penetration by Yr 5; ASP $15k; gross margin 72%.
• Bull: Japan approval 2023, US approval 2026; 25% penetration; ASP $18k (premium pricing confirmed); gross margin 78%; EU launch 2025.
• Bear: Japan approval 2025 (regulatory delay); US approval 2028; 8% penetration; ASP $12k (reimbursement compression); gross margin 60%.
• Key flex variables: launch timing (regulatory), penetration ramp (competitive/adoption), ASP, COGS (CDMO scale).

Required sheets / outputs:

1. Assumptions - all drivers in one input tab
2. R&D Burn - quarterly cash burn, headcount, opex by function; runway to approval
3. Market Model - prevalence → incidence → treated pool → Aurion share, by geography (Japan, US, EU)
4. Revenue Build - procedures × ASP × geography
5. P&L - revenue, COGS, gross profit, R&D, SG&A, EBIT, net income
6. Cash Flow / Runway - operating cash burn, funding rounds, ending cash
7. Scenario Toggle - Base / Bull / Bear switchable on assumptions tab
8. KPI Summary - peak penetration, revenue at scale, gross margin, cash inflection