New Drug Opportunity Assessments  Strat Planning For Future Success
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New Drug Opportunity Assessments Strat Planning For Future Success

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Pharmaceutical Business Development, Marketing and Strategic Planning Groups need an early read on opportunities, but oftentimes don’t have time or budget for extensive market research. ...

Pharmaceutical Business Development, Marketing and Strategic Planning Groups need an early read on opportunities, but oftentimes don’t have time or budget for extensive market research.

Pharmacision presents a step by step opportunity assessment and valuation process through a case study format.

Benefits of employing this process:
Quickly weed out projects with very low probability of commercial success,
Construct a framework for deeper dive assessments to validate and refine assumptions when greater market knowledge is needed before making go/no go decisions, Support clinical development and commercialization strategic planning, Reduce overall costs.

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New Drug Opportunity Assessments  Strat Planning For Future Success New Drug Opportunity Assessments Strat Planning For Future Success Presentation Transcript

  • New Drug Opportunity Assessment Process Creating Strategic Planning Tools For Future Product Commercial Success
  • Why Conduct Early Stage Opportunity Assessments and Valuations? Very often, Business Development, Marketing and Strategic Planning Groups need an early read on opportunities, but don’t have time or budget for extensive market research. Early stage pharma and diagnostic company business planning Prep for investor presentations In-licensing evaluations R&D evaluations and portfolio planning We present a step by step opportunity assessment and valuation process through a case study using actual historical data and a fictitious new drug candidate for the treatment of Clostridium Difficile Associated Disease (C.Diff.). Benefits of employing this process: Quickly weed out projects with very low probability of commercial success Constructs a framework for deeper dive assessments to validate and refine assumptions when greater market knowledge is needed before making go/no go decisions Supports clinical development and commercialization strategic planning Reduces overall costs: Leverages information you know up front or can gain through secondary data sources Identifies key unanswered market related questions that impact future commercial success Limits need for primary market research and additional advisory board meetings to address key unanswered market related questions Copyright © 2009. Pharmacision LLC, www.rapid-insights.com, info@pharmacision.com 2
  • CDiff New Product Opportunity Assessment Case Study CDiff NewProd Concept IV compound with non-clinical data showing potential to provide effective therapy for the treatment of refractory Clostridium Difficile Associated Disease (CDiff) Disease Description Infectious diarrhea caused by antibiotic use and disruption of normal flora Can lead to significant morbidity and mortality, especially in elderly Growing problem in hospitals Treatment Stop antibiotics Metronidazole or Vancomycin New compounds in development Unmet medical need Emergence of hypervirulent strains with high recent growth in number of hospital CDiff cases Recurring cases hard to resolve High documented opportunity costs CDiff NewProd medical opportunity Presumed Hospital use due to IV status Limited outpatient use due to anticipated future competition Need Initial evaluation of out-licensing opportunity for CDiff NewProd Position with investors to raise additional capital Copyright © 2009. Pharmacision LLC, www.rapid-insights.com, info@pharmacision.com 3
  • Assessment and Valuation Process
  • Construct Addressable Market Projections Addressable market = CDiff hospital market Explore Current trends with available data sources Make assumptions on future trends with available info: Lit searches, prior advisory board feedback, existing market research These assumptions will greatly influence sales projections! 500k to 700k Projected Clostridium Difficile US Inpatient Hospital 800,000 Discharges By 2018 Projected Launch Year 700,000 600,000 Actuals Projected 500,000 400,000 300,000 200,000 100,000 Source: HCUP Nationw ide Inpatient Sample, 2005, Agency for Healthcare Research and Quality; Pharmacision LLC projection 0 1993 1995 1997 1999 2001 2003 2005 2007 2009 2011 2013 2015 2017 Copyright © 2009. Pharmacision LLC, www.rapid-insights.com, info@pharmacision.com 5
  • Segment, Quantify, and Prioritize Target Markets 2018 Market Projections Based on Current Patient Distributions Current (2005) Prevalence of Inpatient CDAD cases ( All listed ICD-9-CM diagnoses) Age Group 0 - 17 yrs Prevalence 20,000 % Total Pts 3% Identify target 18 - 64 yrs 65+ yrs 170,000 410,000 28% 68% Estimate 600,000 patient addressable market size in Total 600,000 100% market size Source: 2005 HCUP Nationwide Inpatient Sample, Agency for Healthcare Research and Quality 2018 Disease Stage Breakdown Mild Moderate Map and Age Group (resolve upon DC antibiotics) (metronidazole/ Prolonged (Last Vanco effective) > 10 days) Severe (Complications) Identify All Ages 25% 35% 30% 10% 100% 0 - 17 yrs 25% 35% 30% 10% 100% Segments 18 - 64 yrs 65+ yrs 25% 25% 35% 35% 30% 30% 10% 10% 100% 100% within target Sources: Kyne et al, Factors associated with prolonged symptoms and severe disease due to C Difficile, Age and market Ageing 1999;28:107-113) Quantify Target Market Projection (Severity Approach) Mild Moderate segments (resolve upon (metronidazole/ Prolonged (Last Severe Age Group DC antibiotics) Vanco effective) > 10 days) (Complications) Totals Prioritize 0 - 17 yrs 18 - 64 yrs 5,000 42,500 7,000 59,500 6,000 51,000 2,000 17,000 20,000 170,000 Segments 65+ yrs 102,500 143,500 123,000 41,000 410,000 Total 150,000 210,000 180,000 60,000 600,000 Copyright © 2009. Pharmacision LLC, www.rapid-insights.com, info@pharmacision.com 6
  • Refine Segments Further Based on New Prod Value Prioritize targets based on assumptions of where your new drug will have greatest hypothesized value proposition for patients CDiff NewProd has greatest value in severe and Prolonged/ complicated hospital C. Diff cases CDiff NewProd has Less value, but still may be viable option if C. Diff case is prolonged, but uncomplicated Target Market Projection Severe Prolonged with Relapses High Unmet Moderate High Unmet need need Unmet Need First Relapse/ complications + Multiple Age Group Severe Total Prolonged relapses Prolonged/ Prolonged/ Severe Complicated Unomplicated 0 - 17 yrs 2,000 6,000 828 5,172 18 - 64 yrs 17,000 51,000 9,792 41,208 65+ yrs 41,000 123,000 36,900 86,100 Total 60,000 180,000 47,520 132,480 Copyright © 2009. Pharmacision LLC, www.rapid-insights.com, info@pharmacision.com 7
  • Estimate Level of Unmet Need and Make Price Assumptions Segment target CDiff Expected Severity market Prolonged/ Prolonged/ Low Age Uncomplicated Complicated Severe Potential Explore opportunity 0 - 17 yrs Mild Moderate Severe costs & unmet needs Extreme by segment 18 - 64 yrs Mild Severe Severe Extreme Make pricing 65+ yrs Low Moderate Severe Severe High assumptions based on Potential Potential estimated NewProd Hospital Incremental Cost Increase Due to Cdiff added potential Prolonged/ Prolonged/ Low clinical value Age Uncomplicated Complicated Severe Potential For CDiff NewProd, 0 - 17 yrs neg $1,391 $6,567 we assume $3,000 18 - 64 yrs neg $6,567 $20,459 per course of Tx as a 65+ yrs $1,391 $6,567 $20,459 fair market price that Low High Potential Potential will max profits (NPVs) Sources: Kyne et al, Health Care Costs and Mortality Associated Copyright © 2009. Pharmacision LLC, www.rapid-insights.com, info@pharmacision.com 8 with Nosocomial Diarrhea Due to C Diff. Clin Inf Dis. 2002;34:346-53., Pharmacision modeling
  • Estimate Market Potential at Launch Map out size of opportunity by segment CDiff NewProd Market Potential Map 2018 Market Size (000s) Prolonged/ Prolonged/ Low Age Uncomplicated Complicated Severe Potential 0 - 17 yrs 5 1 2 18 - 64 yrs 41 10 17 65+ yrs 86 37 41 Low High Potential Potential Addressable Annual Target Market Size: 240,000 Highest Potential Annual Target Market Size: 190,000 Copyright © 2009. Pharmacision LLC, www.rapid-insights.com, info@pharmacision.com 9
  • Estimate Peak Market Penetration Estimate level of peak use within each segment Factor in NewProd value prop., current and future competition These assumptions will greatly impact product sales projections! CDiff NewProd Projected Market Shares* Prolonged/ Prolonged/ Low Age Uncomplicated Complicated Severe Potential 0 - 17 yrs 0% 0% 25% 18 - 64 yrs 0% 10% 30% 65+ yrs 10% 25% 35% Low High Potential Potential *Estimates of steady-state market shares after initial launch uptake Copyright © 2009. Pharmacision LLC, www.rapid-insights.com, info@pharmacision.com 10
  • Calculate Peak Patient Estimates From Assumptions Project NewProd peak use Projected Peak CDiff NewProd Patients* (000s) Prolonged/ Prolonged/ Age Uncomplicated Complicated Severe Total 0 - 17 yrs 0 0 1 1 18 - 64 yrs 0 1 5 6 65+ yrs 9 9 14 32 Totals 9 10 20 39 *Assume actual peak patients will be higher when accounting for population growth Copyright © 2009. Pharmacision LLC, www.rapid-insights.com, info@pharmacision.com 11
  • Estimate Probability of Success Factor in risk and probabilities of success Approval Commercial success Prob of Stage Time (Yrs) Success* Pre-Clinical 2 40% Phase I/IIa 2 65% Phase IIb 2 44% Phase III 3 65% Approval 1 80% Cum Total 10 6% *Sources: DiMasi 2001, Kola 2004, Avance * For Immunology drugs in development Copyright © 2009. Pharmacision LLC, www.rapid-insights.com, info@pharmacision.com 12
  • Development Timeline and Costs Create general estimates of development costs and timeline based on historical data and comparable drug development programs Drug Development Timeline and Risks IND submission File NDA Pre-Clinical Testing Phase I Phase II Phase III NDA Review Total Years 1.5 1.5 2 3.5 1.5 8.5 Expected Costs ($ millions) in 2007$ $2 $13.5 $28.3 $81.2 $2.5 $127 20 to 100 100 to 500 1,000 to 5,000 Test Population healthy subjects patients patients n/a n/a Confirm Evaluate effectiveness, Determine efficacy, optimal monitor adverse safety and dosing, side reactions from Purpose dosage effects long-term use n/a n/a Sources: Risks in new drug development: Approval success rates for investigational drugs ; Clin Pharmacol Ther 2001;69:297-307. The Drug Discovery, Development and Approval Process , PHRMA website R&D Costs and Returns by Therapeutic Category ; Drug Information Journal, Vol 38, 2004. Copyright © 2009. Pharmacision LLC, www.rapid-insights.com, info@pharmacision.com 13
  • Make Sales Ramp Up Projections Estimate uptake over product life cycle % Peak Pt Share by year since launch 100.00 90.00 80.00 70.00 60.00 50.00 40.00 30.00 20.00 10.00 0.00 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Copyright © 2009. Pharmacision LLC, www.rapid-insights.com, info@pharmacision.com 14
  • NewProd Post-Launch R&D and Marketing Expense Assumptions Make “Best Guess” incremental Post-launch costs for: Regulatory commitments Driving initial product trial, usage, and brand loyalty Yr 2018 ($000s) Post-launch R&D Phase IV (per year costs, run for 2 years) $5,376 Marketing Advertising and Promotion (campaign and collateral material dev) $5,376 Advocacy Development $3,360 Promotional Medical Education $5,376 Continuing Medical Education $3,360 Publications (peer reviewed and trade publications) $4,032 Sales Training $1,344 Public Relations $1,344 Conventions $2,016 Professional Media (journal ads) $2,688 Direct to Consumer Media (print, limited TV and on-line) $0 Market Access (Pricing, reimbursement, pharmacoeconomics) $3,360 Market Research and competitive intelligence $1,344 Sampling program (samples, packaging, shipping) $0 Total Marketing Expenses $33,598 Source: Pharmacision LLC, MedThink Communications, Cutting Edge. US Launch: Phase IIIa, Phase IIIB and Launch Year Brand Commercialization Copyright © 2009. Pharmacision LLC, www.rapid-insights.com, info@pharmacision.com 15
  • NewProd Post-Launch Sales Force Expense Assumptions Make “Best Guess” incremental Post-launch costs for: Driving initial product trial, usage, and brand loyalty Sales Force Projected Costs Rep Capacity Bed Size # Hospitals Hospitals/Rep Reps required 200 - 400 1,000 15 65 401+ 600 10 60 Sales Force FTEs Required 125 # Reps needed: 125 #MSLs needed: 15 # mgrs needed 20 Cost per rep($2008): $220,000 Cost per mgr/MSL($2008): $300,000 Total Sales Force Cost in 2008: $38,079,085 2008 FTE Cost (assume costs shared with two other critical care specialty products): $12,693,028 2008 2018 Incremental Sales Force Cost $12,693 $17,058 Source: Pharmacision estimates Total Marketing and Sales: $37,693 $50,656 Marketing and Sales Cost Budget Growth Rate: 3.00% Copyright © 2009. Pharmacision LLC, www.rapid-insights.com, info@pharmacision.com 16
  • Combine Mkt Assumptions and Cost Projections in a Modeling Exercise Create tool to support decision making “Box” to combine all assumptions and evaluate outputs Estimated Cost of Goods per course of therapy R&D, marketing and sales expenses Pricing Growth curves Peak sales Profitability and break even points NPV (Net Present Value: the value of expected cash flows starting in the present time period through the life of the product once launched) rNPV* (risk adjusted Net Present Value: NPV when you factor in probabilities of success) Licensor/licensee valuations Term sheet evaluations Investor returns “What-if” scenario planning Starting point for more sophisticated analyses: Real options Monte Carlo *rNPV can serve as a good valuation measure for a drug development project Copyright © 2009. Pharmacision LLC, www.rapid-insights.com, info@pharmacision.com 17
  • Pre-Launch Risk Adj Incremental Cash Flow Assumptions and Model 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 Year1 Year 2 Year3 Year4 Year5 Year6 Year7 Year8 Year9 Year10 Pre-Clinical Pre-Clinical Phase I/IIa Phase I/IIa Phase IIb Phase IIb Phase III Phase III Phase III NDA Transition Rate 100% 40% 100% 65% 100% 44% 100% 100% 65% 80% G&A and R&D Costs ($000s) $775 $775 $850 $850 $4,386 $4,386 $12,200 $12,200 $12,200 $2,000 Discount Rate Small Pharma 18% Discount Rate Pharma Licensor 11% Probability of Occurring 100% 100% 40% 40% 26% 26% 11% 11% 11% 7% 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 Patient Estimates Expected Peak Patient Total Over Product Life Cycle (est. at launch) Population Growth Factor* % Peak Patient Totals (uptake curve) Projected US Patient Totals on NewProd Revenues Average Revenue per Course of Therapy $3,000 $3,120 $3,245 $3,375 $3,510 $3,650 $3,796 $3,948 $4,106 $4,270 Annual rate of price increases: 4.00% Projected US Revenues ($000s): Cost of Goods Sold Avg Cost per Course of Therapy (COT) $427 $444 $462 $480 $500 $520 $540 $562 $584 $608 COGS inflation 4% COGS Gross Margin Gross Profit($000s): Operating Expenses G&A and R&D $775 $775 $850 $850 $4,386 $4,386 $12,200 $12,200 $12,200 $2,000 Sales, Marketing Ops, CME $25,328 Annual inflation for SM&CME 3% (Increase years 2 - 8, decrease yrs 9 - 15) Total Operating Expenses ($000s) $775 $775 $850 $850 $4,386 $4,386 $12,200 $12,200 $12,200 $27,328 Effective Tax Rate 26% Pre-Tax Earnings ($000s) ($775) ($775) ($850) ($850) ($4,386) ($4,386) ($12,200) ($12,200) ($12,200) ($27,328) Effective Tax Rate 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% Probability of Occurring 100% 100% 40% 40% 26% 26% 11% 11% 11% 7% Risk Adjusted Net Cash Flows ($000s) ($775) ($775) ($340) ($340) ($1,140) ($1,140) ($1,396) ($1,396) ($1,396) ($2,032) Copyright © 2009. Pharmacision LLC, www.rapid-insights.com, info@pharmacision.com 18
  • Post-Launch Risk Adj Incremental Cash Flow Assumptions and Model 2008 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 Year1 Yr1 Yr2 Yr3 Yr4 Yr5 Yr6 Yr7 Yr8 Yr9 Yr10 Pre-Clinical Launch mid-year Market Market Market Market Market Market Market Market Market Transition Rate 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% G&A and R&D Costs ($000s) $775 Discount Rate Small Pharma 18% Discount Rate Pharma Licensor 11% Probability of Occurring 100% 6% 6% 6% 6% 6% 6% 6% 6% 6% 6% 2008 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 Patient Estimates Expected Peak Patient Total Over Product Life Cycle (est. at launch) 39,000 39,780 40,576 41,387 42,215 43,059 43,920 44,799 45,695 46,609 Population Growth Factor* 2.000% % Peak Patient Totals (uptake curve) 5% 24% 50% 76% 91% 97% 99% 100% 95% 90% Projected US Patient Totals on NewProd 1,773 9,557 20,288 31,444 38,377 41,739 43,485 44,658 43,367 41,934 Revenues Average Revenue per Course of Therapy $3,000 $4,441 $4,618 $4,803 $4,995 $5,195 $5,403 $5,619 $5,844 $6,077 $6,321 Annual rate of price increases: 4.00% Projected US Revenues ($000s): $7,872 $44,139 $97,444 $157,068 $199,370 $225,510 $244,342 $260,965 $263,558 $265,049 Cost of Goods Sold Avg Cost per Course of Therapy (COT) $427 $632 $657 $684 $711 $739 $769 $800 $832 $865 $900 COGS inflation 4% COGS $1,120 $6,282 $13,870 $22,356 $28,377 $32,098 $34,778 $37,144 $37,513 $37,725 Gross Margin 86% 86% 86% 86% 86% 86% 86% 86% 86% 86% Gross Profit($000s): $6,752 $37,856 $83,575 $134,712 $170,993 $193,412 $209,564 $223,821 $226,045 $227,324 Operating Expenses G&A and R&D $775 $5,376 $5,376 Sales, Marketing Ops, CME $50,656 $52,176 $53,741 $55,353 $57,014 $58,725 $60,486 $62,301 $60,432 $58,619 Annual inflation for SM&CME 3% Total Operating Expenses ($000s) $775 $56,032 $57,552 $53,741 $55,353 $57,014 $58,725 $60,486 $62,301 $60,432 $58,619 Effective Tax Rate 26% Pre-Tax Earnings ($000s) ($775) ($49,280) ($19,695) $29,833 $79,359 $113,979 $134,688 $149,078 $161,520 $165,613 $168,705 Effective Tax Rate 0% 0% 0% 26% 26% 26% 26% 26% 26% 26% 26% Probability of Occurring 100% 6% 6% 6% 6% 6% 6% 6% 6% 6% 6% Risk Adjusted Net Cash Flows ($000s) ($775) ($2,932) ($1,172) $1,313 $3,493 $5,017 $5,929 $6,563 $7,110 $7,290 $7,427 Copyright © 2009. Pharmacision LLC, www.rapid-insights.com, info@pharmacision.com 19
  • Project Cash Flows & NPVs Assuming Outlicensing at Phase IIb License deal at start of phase IIb Milestones/Upfronts DCF Phase I Phase II $5,000 Phase III $5,000 NDA Approval $8,000 $10,000 Royalties 6.0% Predict licensing 2010 Year3 2011 Year4 2012 Year5 2013 Year6 2014 Year7 2015 Year8 2016 Year9 2017 Year10 2018 Yr1 terms based on Phase Phase I/IIa Phase I/IIa Phase IIb Phase IIb Phase III Phase III Phase III NDA Launch Transition probability Probability 100% 100% 44% 100% 100% 44% 100% 44% 65% 44% 80% 29% 100% 23% comparable Revenues ($000s) $0 $0 $0 $0 $0 $0 $7,872 recent deal terms G&A and R&D Expenses $4,386 $4,386 $12,200 $12,200 $12,200 $2,000 $5,376 COGS Marketing and Sales $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $25,328 $1,120 $50,656 Conduct Milestones $5,000 $5,000 $8,000 $10,000 Royalties $472 valuations at time Expenses (for Licensee) $9,386 $4,386 $17,200 $12,200 $12,200 $35,328 $67,625 PHARMA LICENSEE of expected Effective Tax Rate Risk adjusted CF 0% ($9,386) 0% ($4,386) 0% ($7,568) 0% ($5,368) 0% ($5,368) 0% ($10,104) 0% ($13,671) outlicensing and Discount Risk adjusted net DCF 100% ($9,386) 90% ($3,952) 81% ($6,142) 73% ($3,925) 66% ($3,536) 59% ($5,996) 53% ($7,309) for the present (11% discount rate used) rNPV $17,460 time period BIO-TEC Effective Tax Rate 26% 0% 26% 0% 0% 26% 26% Valuations Risk Adjusted CF $5,000 $0 $2,200 $0 $0 $2,288 $2,396 Discount Risk Adjusted DCF 100% $3,700 90% $0 81% $1,321 73% $0 66% $0 59% $1,005 53% $948 support decision- (18% discount rate used) rNPV in 2012 $14,071 Value of license for US rights making Value share Total Milestone and Royalty 45% Note: Special Payments ($000s): $202,029 $4 thanks to Avance Initial Valuation Assuming Outlicensing at start of Phase I/Iia 2008 2009 2010 2011 2012 for sharing Cash Flows Prob rCFs 100% ($775) 100% ($775) 40% ($340) 40% ($340) 26% $3,658 licensing model Discount Rate: PV Cash Flows 100% ($775) 85% ($657) 72% ($244) 61% ($207) 52% $1,887 (www.avance.ch) Total Value rNPV ($000s) $4 Copyright © 2009. Pharmacision LLC, www.rapid-insights.com, info@pharmacision.com 20
  • Evaluate Valuations Based on Different Assumptions For CDiff NewProd Case Study (assuming $3k/course of therapy leads to product adoption): Don’t invest if you think market will flatten out in next few years Still risky investment if you think market will double by launch, all else equal Likely to need prolonged market growth to make investment attractive Need market research to learn more about expectations for future hospital CDiff growth rates before making go/no go decisions to invest or continue development Valuation Scenarios Scenarios For Different Market Growth Levels- Assume project successful in clinical trials, outlicensing occurs, $3000 pricing, and sales projections reached Low Market Growth Moderate Market Growth Continuation of High Recent Market Growth Total Hospital C Diff Mkt at Launch: 500,000 Total Hospital C Diff Mkt at Launch: 600,000 Total Hospital C Diff Mkt at Launch: 700,000 Risk Adjusted NPV: ($1,020,000) Risk Adjusted NPV: $4,000 Risk Adjusted NPV: $650,000 Potential Licensing Agreement Potential Licensing Agreement Potential Licensing Agreement Licensor % of CF Value (Goal > 40%): 45% Licensor % of CF Value (Goal > 40%): 45% Licensor % of CF Value (Goal > 40%): 40% Milestone Payments ($MM): Milestone Payments ($MM): Milestone Payments ($MM): Phase II $2,000 Phase II $5,000 Phase II $5,000 Phase III $2,000 Phase III $5,000 Phase III $7,000 NDA $5,000 NDA $8,000 NDA $8,000 Approval $10,000 Approval $10,000 Approval $15,000 Royalties: 3% Royalties: 6% Royalties: 8% Investors will not realize required rate of return in this scenario NOTE: Estimated 26% Probability of reaching phase IIb and outlicense stage where investors realize any return Exit Valuation estimates represents the present value of expected future stream of revenues to founder and investors due to milestone and royalty payments. Licensing revenues are not guaranteed and are based on succesful licensure and commercial success once product is launched Model assumes that company will have a lean organizational structure and effectively outsource key clinical development functions Timeline should be considered realistic, but aggressive Assumes company will be successful negotiating a licensing deal where company will realize >40% of expected value from future cash flows Copyright © 2009. Pharmacision LLC, www.rapid-insights.com, info@pharmacision.com 21
  • Explore Opportunity Further with Primary Market Research Test assumptions with advisory board Primary market research Conduct qualitative interviews (conversations, NOT surveys) “Gut check” and test assumptions with wider range of customers (i.e. providers, patients, payors) Answer targeted unanswered questions Discover opportunities not initially realized or considered Explore pitfalls and challenges Combine Primary research + secondary research to reassess opportunity Refine commercialization roadmap and decision criteria Copyright © 2009. Pharmacision LLC, www.rapid-insights.com, info@pharmacision.com 22
  • Key Take-Aways It’s never too early to evaluate the future commercial potential for compounds in development. Market models are not crystal balls and forecasts are best guesses. However, they provide a useful tool supporting decision making and help guide product development decisions. The greatest value in process is learning how market dynamics, predicted product adoption, and expectations for licensing terms will impact cash flows and profitability if compounds are successfully outlicensed, approved by the FDA, and launched. Working through this process will highlight the commercially important factors that you already know about your target markets and compounds in development and alert you to those that you need to know. May reduce future market research costs Focus projects to answer “need to know unanswered questions” that drive product sales and cash flows May help guide clinical trial design to address commercial needs Select end points that lead to commercially compelling product labels if products are FDA approved and launched Copyright © 2009. Pharmacision LLC, www.rapid-insights.com, info@pharmacision.com 23
  • Pharmacision LLC Service Offerings Strategic Planning Business strategy and plan development In/out-licensing commercial due diligence assessments/preparation New product planning New market and competitive landscape assessments Market modeling Demand forecasting and financial NPV analyses Marketing Initiatives Brand strategy and marketing plan development Positioning and message development Targeting strategy development Professional and patient advertising campaign development Marketing and communication material development Copyright © 2009. Pharmacision LLC, www.rapid-insights.com, info@pharmacision.com 24
  • Copyright © 2009. Pharmacision LLC, www.rapid-insights.com, info@pharmacision.com 25
  • Contact Information Pharmacision LLC Thomas Marten President (734)895-3670 tmarten@pharmacision.com Copyright © 2009. Pharmacision LLC, www.rapid-insights.com, info@pharmacision.com 26