Building a business case for a fully continuous biomanufacturing platform

Transcription

1 Building a business case for a fully continuous biomanufacturing platform Sol Pompe disease Argentina Integrated Continuous Biomanufacturing Jason Walther 23 October

2 Fully continuous biomanufacturing platform Genzyme developing a continuous integrated platform Technical results are promising But can we justify the platform from a business perspective? And can we use economic modeling to guide development? 2

3 Economic drivers for the continuous platform Universal platform CAPEX OPEX Risk Omni-product facilities Common work force Flexible infrastructure Step reduction Smaller facilities Simpler process Volume reduction Smaller facilities No scale-up Single-use tech Faster build times Reduced turnaround Closed process More automation Increased complexity Less labor Steady state Consistent operation Steady quality High-productivity Smaller facilities Media requirements Can we quantify these advantages and disadvantages? 3

4 Financial valuation methodology Estimate CAPEX/OPEX using BioSolve software Estimate platform dev costs and lay out a future product timeline Predict discounted cash flows for legacy & continuous platforms Calculate financial indicators (e.g., NPV) and make assessment Facility Estimates CAPEX/OPEX savings using the new platform Cash Flow Projections Discount future costs Financial Indicators CVI, NPV, IRR, etc. Development Costs Launch Scenarios Assessment Inputs Outputs

5 Facility estimates: CAPEX and OPEX Use BioSolve software package Define process (unit ops, scaling rules, assumptions) Calibrate cost data (equipment, materials, labor, etc.) Benchmark against previous internal and external projects Facility Scale (Reactor # and Size) Facility CAPEX (Actual:Estimated) Facility A 4X20,000L 104% Facility B 12X12,000L 101% Facility C 6X15,000L 101% Facility D 3X10,000L 102% Facility E 3X4,000L 120% Biosolve capital estimates are acceptably accurate 5

6 Facility estimates: Platform assumptions Legacy Platform Continuous Platform mab 500 kg/y US DS Time IVCD Titer Fed-batch 1X10,000L SS Batch 12 days 3000 Mcell h/ml 3.5 g/l US DS Time VCD Titer Suspension perfusion 2X500L SU Continuous 60 days 100 Mcell/mL 1.4 g/l Enzyme 20 kg/y US DS Time VCD Titer Microcarrier perfusion 2X2,000L SS Batch 60 days 5 Mcell/mL 0.05 g/l US DS Time VCD Titer Suspension perfusion 1X500L SU Continuous 60 days 100 Mcell/mL 0.5 g/l 6

7 Facility estimates: Platform assumptions CAPEX ($M) OPEX ($/g) mab 500 kg/y Legacy 2X 1.2X 1X 1X Continuous Enzyme 20 kg/y 3X 50X 1X 8X 7

8 Cost impacts of the fully continuous platform mab CAPEX mab OPEX % overall cost Overall: 54% Overall: 20% 8

9 CAPEX/OPEX sensitivity analyses Red = More Savings Cell-Specific Perfusion Rate CAPEX Savings (Fed-Batch mab Continuous mab) Viable cell density OPEX Savings (Fed-Batch mab Continuous mab) 9 Financial estimates can guide process development (For example, CSPR and VCD targets)

10 CAPEX/OPEX sensitivity analyses Red = More Savings Cell-Specific Perfusion Rate ΔNPV for a single facility (Fed-Batch mab Continuous mab) Viable cell density 10 Financial estimates can guide process development (For example, CSPR and VCD targets)

11 Financial valuation methodology Facility Estimates CAPEX/OPEX savings using the new platform Cash Flow Projections Discount future costs Financial Indicators CVI, NPV, IRR, etc. Development Costs Launch Scenarios Assessment Inputs Outputs

12 Product launch scenario Create a hypothetical product timeline with various mab and enzyme product launches Calculate NPV for two scenarios Legacy platforms (fed-batch and microcarrier perfusion) Universal continuous platform Compare NPVs to estimate value of new platform

13 Advanced Modeling An Integrated Approach Sales Profiles Development Profiles Product Definition Dashboard Stocking Strategy Product NPV Portfolio NPV In partnership with Biopharm Services Ltd. Manufacturing Network 13

14 Relative cash flow projections ΔNPV for product portfolio mab OPEX Enzyme OPEX mab CAPEX Enzyme CAPEX Development Cost discount rate = 7% Clear benefits to new platform (given the assumptions) 14 Hundreds of millions of dollars in potential savings

15 Relative cash flow projections ΔNPV for product portfolio High demand Medium demand Low demand Different product launch scenarios can be investigated 15 Continuous platform competes in a variety of scenarios

16 Conclusions Infrastructure in place for economic modeling of future platforms Preliminary analysis shows strong, quantifiable business drivers for continuous platform We will continue to revisit and improve assumptions Additional sensitivity analyses Expand comparisons to other platforms (e.g., disposable FB) Process development guidance Cell density and CSPR are influential upstream parameters Similar parameters will be found for downstream process 16

17 Acknowledgments Genzyme Late Stage Process Development Genzyme Capital Finance Genzyme Industrial Affairs Sanofi Biologics Research & Development Biopharm Services 17