objective insights (brett gaspers) capabilities presentation

www.ObjectiveInsights.com

Capabilities

http://www.objectiveinsights.com

© Copyright 2016 Objective Insights, Inc. All Rights Reserved.

Company Overview

• Our Approach • Consulting Services • OI Modeling Tools • Our Strengths

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Background


Our Purpose

Objective Insights is a consulting firm dedicated to providing health care companies with the marketing and financial analysis they need to make informed decisions about their business opportunities.

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Background


Our Background

• Company personnel have pharmaceutical industry experience – Merck Biogen Syntex

• Founded in 1994 • Provides ad hoc consulting and stand-alone forecasting and analysis

tools (OI Tools) • Consulting staff

– Brett Gaspers Charley Hooper • www.ObjectiveInsights.com • 530-271-1940 (CA) / 425-745-9667 (WA)

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Background


Our People

• Brett Gaspers - Founder of Objective Insights – B.S. Chemical Engineering - Massachusetts Institute of Technology – M.B.A. - Stanford University Graduate School of Business – First Manhattan Consulting Group - Research analyst – Biogen - Process development and manufacturing – Syntex Laboratories - Forecasting, reimbursement, patient

assistance program, market research

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Background


Projects and Clients

• Successfully completed 350 projects • More than 50 clients

Pharmaceutical • Biotechnology • Diagnostics • Vaccine • Device

• Clients include:

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Background


Therapeutic Area Experience

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Background

Analgesia Inflammation & Allergy

Autoimmune Disorders Metabolic Disorders

Cardiovascular Musculoskeletal

CNS / Psychiatric Oncology

Dermatology Ophthalmology

Diagnostics Pulmonary

Gastroenterology Urology

Infectious Diseases Vaccines

Approach


Our Analysis Philosophy

• Iteratively refine the approach and analytic model with the client to ensure our solution correctly addresses the problem

• Provide a usable, transparent, yet sophisticated analytic framework – Ensure analysis is transparent in structure and information

• Parametric & parsimonious design – All inputs are visible, not aggregated – Make the model as simple as possible

• Thoroughly documented assumptions, backed by data and research • Time and date stamps for version control • Model inputs, outputs, and calculations are clearly labeled (e.g., historical revenue

total prescriptions per month, in thousands) – Model calibrated to established data – Incorporate risk analysis

• Monte Carlo simulation, decision trees • Aid understanding of upsides and downsides • Sensitivity analysis to identify model drivers

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Approach


Decision-Based ManagementSM

• From information to decision – “If we have good information, our company will be successful.” ...

not necessarily! – Information is expensive ($$$) and infinite (∞) – Too much information can confuse and slow progress – Much data gathering is useless for making decisions

• From decision to information to decision – “If we make good decisions, our company will be successful.”

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Approach


Decision-Based ManagementSM Process

• Frame the problem: Solve the right one • Focus research efforts

– What affects the analysis most? – What is quickest to implement? – What is the least expensive to implement?

• Keep improving information and refining the model until solution is clear

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Approach


Decision-Based ManagementSM Pyramid

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Approach

Sales Forecast

Secondary Market Research

Primary Market Research

Decision/Objective


Decision-Based ManagementSM Benefits

• Better decisions • Clarity of action • Less costly; information acquisition is targeted to what is needed for

analysis • Faster resolution • Tailored for specific situations

– Reflects your situation and needs

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Approach

Services & Tools


Services & Tools

• Forecasting & Forecast Modeling Tools – New product forecasts (patient-based, prescription-based) – Marketed product forecasts (patient-based, trend-based) – Market assessments – Epidemiology and patient dynamics/patient switch models – Buying Intensity Index™ (BII) – Improves trend-based forecasting

accuracy • Database and Epidemiology Analysis • Business/Problem Modeling • Business Development Deal Modeling • Pricing & Health Economics • Portfolio Analysis & Optimization

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Forecasting

• Understanding the nature of the current and future market is essential to constructing your forecast – Patients

• Fundamental nature of disease – Disease incidence and prevalence, dynamics – Diagnosis and treatment rates

• What ultimately drives demand for your product? – Products

• Adoption rate, peak share, and erosion governed by: – Product characteristics – Competition from other products or substitutes – Level of unmet need – Other customer influences (physicians, hospitals, labs, payers, patients)

• These factors can be estimated from market research and analogs

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Services


Forecast Types

• We help you select the forecasting method appropriate to your product’s characteristics and situation:

– Trend-based forecast (Short-Term Forecaster™) • Product already marketed or to be launched into a well-

established market, forecast out to year 3 – Patient-based forecast (Long-Term Forecaster™, custom dynamics

models) • Market demand still evolving, longer-term forecast needed • Model can be structured using simpler sequential segmentation

approach where complexity of patient dynamics not needed • Patient dynamic models can be used where warranted by

nature of disease (stage, line of therapy, etc.)

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Services


Patient Dynamics Forecasting

• Modeling objectives – Explore particularly complicated disease states in greater depth to

gain understanding of disease progression or treatment regimens – Understand and quantify patient subgroups

• Several approaches to modeling – Accounting approach, Markov process, system dynamics

• OI often implements the accounting approach – Easy to understand and follow in a spreadsheet model – Adequately captures patient dynamics – Tracks the number of patients in each treatment state

• For each time period, some patients move between states • Flow is one-directional over time

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Services


“Simple” Dynamics Example

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Services

ActiveDisease

PresentwithNHL

First-Line Therapy

RelapseTherapy

RefractoryTherapy

NoTherapy

DiseaseRemission

NoTherapy "Cured"

Death

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Antiviral Dynamics Example


Patient Switch Modeling

• Variant of patient dynamics model for marketed products – Uses longitudinal claims data to identify patients new to market,

switching to/from brand, and discontinuing or renewing therapy • Avoids some of the assumption sensitivity of patient dynamics models

by using patient-driven data • Provides better understanding of market dynamics and direction

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Services


Database & Epidemiology Analysis

• Objective Insights can help you determine disease and procedure epidemiology (incidence/prevalence), patient characteristics, and treatment patterns – Produces a better (more accurate, more defendable) forecast – Helps you focus company resources on the right patient segments

• Objective Insights has considerable experience working with various government health databases – National Center for Health Statistics (NHANES, N(H)AMCS, NHDS, NSAS)

• Similar to IMS NDTI (greater level of detail) • NHDS and NSAS capture non-office based treatments

– Agency for Healthcare Research & Quality (MEPS, MCBS, HCUP) • Expenditures and other data related to various health conditions

– Cancer epidemiology (SEER, GLOBOCAN) • We have also researched epidemiology in a number of therapeutic areas

– Sourced from medical literature, databases shown above, and other surveys

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Services


Decision Analysis and Modeling

• We are experts at handling problems that are complex, unique, ill-defined, uncertain, difficult, multidimensional, and/or important – We address your problem with sophisticated analytical methods, creative

“out of the box” thinking, and years of experience in the health care market – Examples

• Developed game theory model to predict competitor behavior • Analyzed sales and contracting data to determine price elasticity for a

marketed product, informing future pricing and contracting strategy • Developed CMC planning model to illuminate and resolve the capacity

decision timeline prior to launch of new pharmaceutical • Analyzed contracting data to determine how contracting terms

affected accounts and developed criteria to identify the most productive accounts relative to terms offered

• Constructed decision model to guide company regulatory filing strategy in conjunction with forecasting project

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Services


Objective Insights Tools

• We distilled our approaches for repeated analyses into OI Tools – Standardization results in greater sophistication and fewer errors

than fully custom models can deliver – OI Tools allow you to focus on the analysis, not building the model

• OI Tools can be customized to fit your company’s situation • Objective Insights can also provide assistance in populating and

operating the models

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Tools


Long-Term Forecaster™

• Patient-based long-term P&L forecast model – Annual, quarterly, and monthly forecasts – Incorporates product deal terms, development timelines, and success

probabilities • Consistent, easy, powerful system

– Forecasts can be set up quickly without a lot of manual tweaking – Assumptions and calculations are easy to document and follow – Easily performs 'what-if' analyses – Monte Carlo simulation for risk analysis, replacing tedious and misleading

upside/downside cases – Forecasts for multiple indications, products, & geographies easily consolidated

and analyzed as a portfolio

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Tools

Monthly, quarterly, & annual forecasts


Long-Term Forecaster™ Structure

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Tools


LTF Assumption Entry

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Tools

Assumption entry includes notes, manual overrides, and graphic display of assumption outcomes

Patients Diagnosed with Indication XYZ Section Last Updated: 8/25/16 4:20:49 PM by Brett V. Gaspers• Enter your numerical assumptions in this section about the proportion of the prevalent or incident patient population that is diagnosed.

2016 2017 2018 2019 2020 2021 2022 2023Initial Values 51% 52% 54% 55% 57% 58% 60% 61%

Override 57% 57%Final Values 51% 52% 54% 55% 57% 57% 57% 61%

Diagnosed Patients (000) 469 487 506 525 545 553 558 605Gross Revenues ($M) $0.0 $0.0 $0.0 $0.0 $0.0 $0.0 $0.0 $0.0

Click (+) to reveal monthly values, (-) to hide

Distribution RangeMonte Carlo Factor Low Most Likely High MC On? Override Present?

12 Diagnosed Patients 90% 100% 110% TRUE Yes

Use arrows to add (up) or Valuedelete (down) population 2016curve segments 50.0%

1065.0%

NotesDiagnosis rate increases as new genotypic assays are developedSource: judgment

ParameterStart Year

Start Value

End ValueElapsed Years

0%

10%

20%

30%

40%

50%

60%

70%

2016

2017

2018

2019

2020

2021

2022

2023

2024

2025

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

PatientsDiagnosedwithIndicationXYZ

Linear


LTF Lifecycle Entry

LTF lifecycle entry allows flexible definition of the lifecycle shape or can use pre-defined analogs

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Tools


LTF Lifecycle Live Graphs

Continually updated lifecycle graphs provide instant feedback when adjusting lifecycle shape

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Tools

0.0%

20.0%

40.0%

60.0%

80.0%

100.0%

120.0%

2016

2017

2018

2019

2020

2021

2022

2023

2024

2025

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

ProductLifecycleandPatientShare

Lifecycle RawShare FinalShare


LTF Competition

• LTF allows up to six competitors launching after your product – Includes specification of launch probability, competitor adoption

curve, and cannibalization pattern

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Tools


LTF Events

• Events can be applied to individual products or all products in market – Events include probability and shape of event evolution

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Tools


LTF R&D Timeline

• The LTF thoroughly models development timelines, costs, and probabilities – All these factors are dynamic

• Changes in timeline also shift development costs and launch date – Development timing and cost also includes Monte Carlo simulation to

better reflect the uncertainty of drug development

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Tools


LTF Reporting Capabilities

The LTF includes extensive tabular and graphical reports of different model variables and outputs

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Tools


LTF Assumption Reporting

The LTF provides a report to list all assumption notes entered in the model on a single page for easy reference

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Tools

Model Notes Report Last Updated: 8/25/2016 4:24:07 PM

Input Page Variable Note

Patients per Year Diagnosed Patients Diagnosis rate increases as new genotypic assays are developedSource: judgment

Diagnosed Patients Seeking Medical Treatment All diagnosed patients seek treatmentEligible Patients Passthrough variable

Revenue per Patient Treatment Days per Year Chronic therapyDoses per Day QD dosingTablets Per Dose One tab per doseAdherence Assumes 75% compliance

Conclusion


Our Strengths

• Company principals work on all projects – Highly experienced in business analytics, healthcare industry background

• High value for quality work • We use powerful and time-tested analytical techniques

– Monte Carlo simulation (custom routine running in Excel models) – Statistical forecasting methods (exp. smoothing, ARIMA)

• Highly satisfied customers since 1994 – 80% of business is with repeat customers – 2009 customer survey showed:

• 85% of respondents said they would recommend OI to a colleague – Other 15% would recommend depending on the work needed

• Over 90% of respondents rated the value and quality of OI’s consulting services and models as good to excellent

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Conclusion

“Simply an excellent choice for assistance” – OI client


Our Results

• We produce high quality decisions, helping you to: – Understand uncertainty, risk, market trends, and dynamics – Quickly establish commercial value – See opportunities others may have overlooked

• We use analysis to generate insights and understanding which lead to a decision that is right for you

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Conclusion

“Great to work with, useful in our decisions.”

“Very good at delivering what the client needs.”

“OI has always impressed me with their modeling capabilities…the

best in the industry in my opinion.”

– Comments from OI client survey

www.ObjectiveInsights.com

Capabilities

http://www.objectiveinsights.com

objective insights (brett gaspers) capabilities presentation

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