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www.epixanalytics.com Risk-based Portfolio Management A pharmaceutical application Palisade 2013 Risk Conference London, June 11 th EpiX Analytics

Risk-based Portfolio Management

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www.epixanalytics.com

Risk-based Portfolio Management A pharmaceutical application

Palisade 2013 Risk Conference London, June 11th

EpiX Analytics

Case study

Objective:

Illustrate the usefulness of MC simulation modeling to forecast a complex pharmaceutical portfolio

Based on real consulting project - portfolio management

© EpiX Analytics LLC

Contents

Background

Model structure

Identification of uncertainties

Definition of evaluation rules

Simulation modeling

Automation & data checks

User- defined evaluation using unified framework

Key outputs

Conclusions

© EpiX Analytics LLC

Background

Pharmaceutical development and manufacturing is “risky”:

Many uncertainties in processes involved

Need for decision-support tool: modeling revenues and margins of portfolios with uncertainties, comparisons of portfolios, identification of risks

Large number of products in portfolio:

Need to come up with unified metrics & framework

Need for data quality control and automation of evaluation procedure

© EpiX Analytics LLC

Model structure and MC simulation modeling

© EpiX Analytics LLC

Model structure

First step: identification of key risks/uncertainties and their drivers along the development and manufacturing processes:

Development & Launch Manufacturing

Expected timing?

Production volumes?

Production costs?

Chance of approval?

Type of molecule

Development phase

Observed delays?

Market demand

Production site

capacity

Type of production

process …

© EpiX Analytics LLC

Revenue and Margin by

Quarter

Product characteristics

(risk drivers) Portfolio risks (uncertain

variables)

Overall

Portfolio value

Risk driver 11

Risk D

Risk E

Risk driver 1

Risk driver 2

Risk driver 3

Risk driver 5

Risk driver 7

Risk driver 8

Risk driver 9

Risk driver 10

Risk A

Risk C

Risk B

Risk driver 6

Risk driver 4

© EpiX Analytics LLC

Model structure

Second step: characterization of uncertainties

Use of data / expert opinion to quantify impact of uncertainties

Establishment of systematic evaluation rules that consider product characteristics

Definition of probability distributions to represent uncertainties

© EpiX Analytics LLC

Pre-clinical

testing Phase I Phase II Phase III On Market

Large 0.5% 5% 45% 90% 100%

Medium 2% 15% 66% 70% 100%

Small 5% 25% 70% 85% 100%

Example: Product approval

Based on development phase and type of molecule under development

Use of historical data on approval

Product approval represented by a series of Binomial distributions with probabilities of approval defined by matrix:

© EpiX Analytics LLC

Unit Price

Unit cost

Development phase

Molecule size

Initial timing

Production forecast

Contract expiry

Initial price

Annual PPI

Initial cost

Product approval

Volume by quarter

Product launch date

Company capacity

Delays observed?

Cost uncertainty

Product A

Unit Price

Unit cost

Development phase

Molecule size

Initial timing

Production forecast

Contract expiry

Initial price

Annual PPI

Initial cost

Product approval

Volume by quarter

Product launch date

Company capacity

Delays observed?

Cost uncertainty

Product B

Unit Price

Unit cost

Development phase

Molecule size

Initial timing

Production forecast

Contract expiry

Initial price

Annual PPI

Initial cost

Product approval

Volume by quarter

Product launch date

Company capacity

Delays observed?

Cost uncertainty

Product C

Risk D

Risk E

Risk driver 1

Risk driver 2

Risk driver 3

Risk driver 5

Risk driver 7

Risk driver 8

Risk driver 9

Risk driver 10

Risk A

Risk C

Risk B

Risk driver 6

Risk driver 4

Risk driver 11

Product …

Overall

Portfolio

Value

© EpiX Analytics LLC

Simulation modeling

Model in @RISK 6:

MC simulation for portfolio evaluation under uncertainty

Excel interface for users - easy to navigate and understand

Due to large number of projects in portfolio, need for quality control and automation

- use of VBA to minimize user errors

© EpiX Analytics LLC

Simulation modeling

Portfolio evaluation

Unified framework for evaluation Pre-defined evaluation framework applied to all products

included in simulation

Automatic running and production of outputs (more to come…)

User-defined Simulation period: up to 10yrs, start date ≥ current date

Projects in portfolio: manual and/or pre-defined group selection (type of product, production site, etc.)

Demo

© EpiX Analytics LLC

Simulation modeling

Automation and Data checks

Importation of data directly from client database Limits errors of data entry

Automatic data check Highlights errors that would affect model results

Products with data errors “locked out”

Security Sheets of cells locked to prevent erroneous changes by users

Instructions guide users to a limited number of sheets where they can 1) configure the simulation 2) view results

Demo

© EpiX Analytics LLC

Key outputs

© EpiX Analytics LLC

Revenue & Margin forecast by portfolio (/quarter, calendar year, 12mth)

Key outputs

© EpiX Analytics LLC

Revenue forecast by project

Key outputs

© EpiX Analytics LLC

Key outputs

© EpiX Analytics LLC

Scatter plot of projects revenue/margin against risks

Key outputs

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Sensitivity charts

Key outputs

© EpiX Analytics LLC

Portfolio management

Model successful, used for short and medium to long term planning and budgeting

Four years of use

Model improved over time (criteria, data, automation, outputs)

Adopted by decision makers – required for planning

© EpiX Analytics LLC

Dr. Solenne Costard Senior Consultant EpiX Analytics LLC

[email protected] Ph: +1 970 372 1212

Thank you