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www.kromite.com KROMITE LLC, © 2016. All Rights Reserved. (267) 983-6305
Page 1
GIVEN THE ECONOMIC PRESSURES OF PATIENT CARE,
PHARMACEUTICAL COMPANIES NEED TO KNOW:
 What is the predicted value of my new
drug even though it is in an early stage of
development?
 What indication sequencing and trial
endpoint design will maximize patient
benefit AND profit?
 What price point for my new drug will
maximize profit across multiple
indications?
Company X developed a new Immunotherapy Oncology drug
blinded as Drug IO that could slow progression of four different solid
tumor cancers based on Phase II clinical trials that were still progressing
and at an early trial maturity.
Critical decisions that were needed to be made from both a valuation and
strategic perspective included:
 Development strategy: Lead and follow-on indication sequence and trial
endpoints to optimize long-term differentiation while achieving short-term
company goals
 Pricing: Target price for Drug IO across all indications that would optimize
revenue and patient access based on product profile endpoints, unmet
needs and market landscape
 Biomarker strategy: Projected value impact of implementing a biomarker
strategy
 Go to market strategy: Whether Drug IO should be marketed to the greatest
number of patients first or to maximize the revenue longer-term across
indications
KROMITE Consulting was engaged to determine the long-term valuation of
this Phase II drug and support Company X in the above critical decisions.
Standard of
Care
Product Profile
& Clinical Plan
Market Size
Competitive
Landscape
Unmet Needs
Indication
Sequence and
Pricing
CASE
STUDY
Forecast
& Revenue
Uncertainty
Valuation of Pharmaceutical Drugs
is more than just a Forecast
www.kromite.com KROMITE LLC, © 2016. All Rights Reserved. (267) 983-6305
Page 2
Analysis and Key Decision Points:
 Developed current Standard of Care across
Stages of Cancer, Lines of Therapy, and 4
cancer types
 Assessed Phase II trial data vs. Standard of
Care
 Aligned client medical, commercial, C-level
executives on expected and range of trial
outcomes & level of differentiation for Drug IO
End point measures blinded for case study
Analysis and Key Decision Points
 Determined patient epidemiology by stage,
line of therapy, tumor type across 7
geographies – defining Size of the Potential
Market
 Utilized multiple data sources to develop
current and future competitive landscape
 Projected market share of Drug IO, including
ranges based on competitive differentiation
and biomarker strategy projected impact
 Identified clinical differentiation and market
benefits of Drug IO by tumor, stage and line of
therapy
WHAT IS THE POTENTIAL PATIENT SIZE FOR EACH INDICATION?
Standard of
Care
Product Profile
& Clinical Plan
Market Size
Competitive
Landscape
Unmet Needs
Indication
Sequence and
Pricing
Standard of
Care
Product Profile
& Clinical Plan
Market Size
Competitive
Landscape
Unmet Needs
Indication
Sequence and
Pricing
Superior vs. standard of care
Comparable vs. standard of care
Inferior vs. standard of care
TABLE 1: DRUG IO PRODUCT
PROFILE VS. STANDARD OF CARE
(FOR EACH INDICATION, STAGE,
LINE OF THERAPY)
WHAT IS DRUG IO’S PRODUCT PROFILE VS. STANDARD OF CARE?
Forecast
& Revenue
Uncertainty
Forecast
& Revenue
Uncertainty
www.kromite.com KROMITE LLC, © 2016. All Rights Reserved. (267) 983-6305
Page 3
Analysis and Key Decision Points:
 Evaluated Drug IO per indication vs.
current and future unmet needs
 Created surrogate pharmaco-economic
tool to compare Drug IO cost of treatment
vs. alternatives
 Recommended indication sequence and
evaluated 3 alternative price points for drug
rationalizing across 4 different cancer
indications
Standard of
Care
Product Profile
& Clinical Plan
Market Size
Competitive
Landscape
Unmet Needs
Indication
Sequence and
Pricing
Table 2: Pricing of Drug IO vs. Market
INDICATION #1
INDICATION #2
INDICATION #3
INDICATION #4
Price Advantage vs. alternative treatments
Price Comparable vs. alternative treatments
Price Disadvantage vs. alternative treatments
Forecast &
Revenue
Uncertainty
Indication
1
Neo + Adjuvant
Metastatic
1st Line
Metastatic
2nd Line
Metastatic
3rd Line (+)
Drug IO
Low TPP
Drug IO
Base TPP
Drug IO
High TPP
Indication
2
Stage 1 and IIb Stage III
Stage IV 1st Line -
Metastatic
Stage IV 2nd Line -
Metastatic
Stage IV 3rd Line -
Metastatic
Drug IO
Low TPP
Drug IO
Base TPP
Drug IO
High TPP
Indication
3
Limited Stage
Extensive Stage
1st Line
Extensive Stage
2nd Line
Extensive Stage
3rd Line
Drug IO
Low TPP
Drug IO
Base TPP
Drug IO
High TPP
Indication
4
Stage 2 Stage 3
Stage 4 1st Line -
Metastatic
Stage 4 2nd Line -
Metastatic
Stage 4 3rd Line -
Metastatic
Drug IO
Low TPP
Drug IO
Base TPP
Drug IO
High TPP
Avg.treatmentprice/patientperyear
blindedforcasestudy WHAT IS THE DRUG PRICING STRATEGY AND INDICATION SEQUENCING?
www.kromite.com KROMITE LLC, © 2016. All Rights Reserved. (267) 983-6305
Page 4
KROMITE developed a forecast
valuation of Drug IO, including
ranges to account for uncertainty
associated with the clinical trial
outcomes (product profile), drug
pricing options and biomarker
strategy impact for 4 indications
across 7 geographies.
Company X was able to use
KROMITE’s analysis to:
GAIN INSIGHTS:
 Understand the value range of their
drug for partnering discussions
 Define patient size and pricing
landscape across indications,
stages, lines of therapy
 Optimize revenue vs. patient access
across indications
MAKE STRATEGIC DECISIONS:
 Select lead indication for
first Phase III trial
 Sequence trials for follow-on
indications
 Define trial designs by stage/line of
therapy based on product profile
and pricing differentiation
 Inclusion of a biomarker strategy in
trials
CASE STUDY RESULTS AND VALUE TO CLIENT:
Click here to submit your challenge
From compound to therapy area to corporate level,
KROMITE can help you optimize
your strategy & investment decisions
0%
5%
10%
15%
20%
25%
30%
$0
$1,000
$2,000
$3,000
$4,000
$5,000
$6,000
2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032
Drug IO Forecast Potential at Base TPP Price Comparison
low price Patient Share base price Patient Share high price Patient Share
World Sales at low price World Sales at base price World Sales at high price

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KROMITE Case Study_Immunotherapy Oncology

  • 1. www.kromite.com KROMITE LLC, © 2016. All Rights Reserved. (267) 983-6305 Page 1 GIVEN THE ECONOMIC PRESSURES OF PATIENT CARE, PHARMACEUTICAL COMPANIES NEED TO KNOW:  What is the predicted value of my new drug even though it is in an early stage of development?  What indication sequencing and trial endpoint design will maximize patient benefit AND profit?  What price point for my new drug will maximize profit across multiple indications? Company X developed a new Immunotherapy Oncology drug blinded as Drug IO that could slow progression of four different solid tumor cancers based on Phase II clinical trials that were still progressing and at an early trial maturity. Critical decisions that were needed to be made from both a valuation and strategic perspective included:  Development strategy: Lead and follow-on indication sequence and trial endpoints to optimize long-term differentiation while achieving short-term company goals  Pricing: Target price for Drug IO across all indications that would optimize revenue and patient access based on product profile endpoints, unmet needs and market landscape  Biomarker strategy: Projected value impact of implementing a biomarker strategy  Go to market strategy: Whether Drug IO should be marketed to the greatest number of patients first or to maximize the revenue longer-term across indications KROMITE Consulting was engaged to determine the long-term valuation of this Phase II drug and support Company X in the above critical decisions. Standard of Care Product Profile & Clinical Plan Market Size Competitive Landscape Unmet Needs Indication Sequence and Pricing CASE STUDY Forecast & Revenue Uncertainty Valuation of Pharmaceutical Drugs is more than just a Forecast
  • 2. www.kromite.com KROMITE LLC, © 2016. All Rights Reserved. (267) 983-6305 Page 2 Analysis and Key Decision Points:  Developed current Standard of Care across Stages of Cancer, Lines of Therapy, and 4 cancer types  Assessed Phase II trial data vs. Standard of Care  Aligned client medical, commercial, C-level executives on expected and range of trial outcomes & level of differentiation for Drug IO End point measures blinded for case study Analysis and Key Decision Points  Determined patient epidemiology by stage, line of therapy, tumor type across 7 geographies – defining Size of the Potential Market  Utilized multiple data sources to develop current and future competitive landscape  Projected market share of Drug IO, including ranges based on competitive differentiation and biomarker strategy projected impact  Identified clinical differentiation and market benefits of Drug IO by tumor, stage and line of therapy WHAT IS THE POTENTIAL PATIENT SIZE FOR EACH INDICATION? Standard of Care Product Profile & Clinical Plan Market Size Competitive Landscape Unmet Needs Indication Sequence and Pricing Standard of Care Product Profile & Clinical Plan Market Size Competitive Landscape Unmet Needs Indication Sequence and Pricing Superior vs. standard of care Comparable vs. standard of care Inferior vs. standard of care TABLE 1: DRUG IO PRODUCT PROFILE VS. STANDARD OF CARE (FOR EACH INDICATION, STAGE, LINE OF THERAPY) WHAT IS DRUG IO’S PRODUCT PROFILE VS. STANDARD OF CARE? Forecast & Revenue Uncertainty Forecast & Revenue Uncertainty
  • 3. www.kromite.com KROMITE LLC, © 2016. All Rights Reserved. (267) 983-6305 Page 3 Analysis and Key Decision Points:  Evaluated Drug IO per indication vs. current and future unmet needs  Created surrogate pharmaco-economic tool to compare Drug IO cost of treatment vs. alternatives  Recommended indication sequence and evaluated 3 alternative price points for drug rationalizing across 4 different cancer indications Standard of Care Product Profile & Clinical Plan Market Size Competitive Landscape Unmet Needs Indication Sequence and Pricing Table 2: Pricing of Drug IO vs. Market INDICATION #1 INDICATION #2 INDICATION #3 INDICATION #4 Price Advantage vs. alternative treatments Price Comparable vs. alternative treatments Price Disadvantage vs. alternative treatments Forecast & Revenue Uncertainty Indication 1 Neo + Adjuvant Metastatic 1st Line Metastatic 2nd Line Metastatic 3rd Line (+) Drug IO Low TPP Drug IO Base TPP Drug IO High TPP Indication 2 Stage 1 and IIb Stage III Stage IV 1st Line - Metastatic Stage IV 2nd Line - Metastatic Stage IV 3rd Line - Metastatic Drug IO Low TPP Drug IO Base TPP Drug IO High TPP Indication 3 Limited Stage Extensive Stage 1st Line Extensive Stage 2nd Line Extensive Stage 3rd Line Drug IO Low TPP Drug IO Base TPP Drug IO High TPP Indication 4 Stage 2 Stage 3 Stage 4 1st Line - Metastatic Stage 4 2nd Line - Metastatic Stage 4 3rd Line - Metastatic Drug IO Low TPP Drug IO Base TPP Drug IO High TPP Avg.treatmentprice/patientperyear blindedforcasestudy WHAT IS THE DRUG PRICING STRATEGY AND INDICATION SEQUENCING?
  • 4. www.kromite.com KROMITE LLC, © 2016. All Rights Reserved. (267) 983-6305 Page 4 KROMITE developed a forecast valuation of Drug IO, including ranges to account for uncertainty associated with the clinical trial outcomes (product profile), drug pricing options and biomarker strategy impact for 4 indications across 7 geographies. Company X was able to use KROMITE’s analysis to: GAIN INSIGHTS:  Understand the value range of their drug for partnering discussions  Define patient size and pricing landscape across indications, stages, lines of therapy  Optimize revenue vs. patient access across indications MAKE STRATEGIC DECISIONS:  Select lead indication for first Phase III trial  Sequence trials for follow-on indications  Define trial designs by stage/line of therapy based on product profile and pricing differentiation  Inclusion of a biomarker strategy in trials CASE STUDY RESULTS AND VALUE TO CLIENT: Click here to submit your challenge From compound to therapy area to corporate level, KROMITE can help you optimize your strategy & investment decisions 0% 5% 10% 15% 20% 25% 30% $0 $1,000 $2,000 $3,000 $4,000 $5,000 $6,000 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 Drug IO Forecast Potential at Base TPP Price Comparison low price Patient Share base price Patient Share high price Patient Share World Sales at low price World Sales at base price World Sales at high price