# Aurion Biotech Financial Model Cell therapy company developing an injectable corneal endothelial cell treatment to restore vision in patients with corneal endothelial disease. - Canonical: https://finamodel.com/startups/aurion-biotech - Excel download: https://finamodel.com/startup-models/aurion-biotech.xlsx - Category: Biotech/Pharma - Model type: SaaS ARR / Valuation - Funding: $120M - Founded: 2022 - Geography: US, EU, Japan (primary markets). Clinical trial in El Salvador (IOTA). Manufacturing partners in Japan (Sumitomo) and US (Cognate / Charles River). - Customer: B2B2C ## About the company Aurion Biotech develops cultured corneal endothelial cell therapy for corneal disease. In a roughly ten-minute outpatient procedure, diseased endothelium is removed and donor cells are injected with a ROCK inhibitor; the cells then align on Descemet’s membrane rather than requiring a conventional corneal transplant. One donor cornea can provide enough cells for more than 100 treatments, removing a major supply constraint and simplifying surgery. The therapy is intended for ophthalmologists and surgical centres, with a Medicare Part B injectable pathway. Research cites $20,000–$25,000 reimbursement per procedure and a Japan-first regulatory sequence. More than 100 patients had been treated, and the first 11 Japan Phase 2/3 patients showed sustained corneal-thickness and visual-acuity improvement through five years without serious adverse events. The model should stage approvals, patients, reimbursement, CDMO capacity, procedure economics, and launch costs. ## What's included - 5-year monthly revenue build with stage-appropriate growth assumptions - Full P&L, headcount plan, and operating-expense schedule - Cash-flow statement, runway, and burn-rate tracking - Valuation via exit multiple with a DCF cross-check - Returns analysis with MOIC and IRR - Unit economics including CAC, LTV, payback, and cohort retention ## Product & value proposition - **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). ## Market - 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. ## Revenue model - **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. ## Traction & metrics - **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. ## Unit economics - **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. ## Competition / moat - **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. ## Team & funding ask / use of funds - **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. --- ## Recommended financial model **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 ## Frequently asked questions ### Is the Aurion Biotech financial model free? Yes. The Aurion Biotech model is a free Excel download with live formulas. ### Can I change the assumptions? Yes. The workbook is editable and its live formulas recalculate when assumptions change.