Pharmaceutical KPI (Interim Version 1.0)
As of May 12, 2010

No.

KPI

Number of Challenges
1to "Unmet Needs"

Description
To understand the degree ofcompanies efforts towards to unmetneeds

To understand the development
capability of new medicine

2 Number of Screening

KPI formula
To let companies to define what "unmet needs"
are and count the number of unmet needs areasthat company engage depending on their own
classification methodology

Practice Example

Application Date

Sample Business Case: ABC company

Relation withFinancials

Merit/Need

Provided once a year (Future) sales
according to the fiscalterm.

We can plan area portfolio strategies
and check if they work properly.
It is also important from a CSR
standpoint.

Provided once a year (Future) sales,
according to the fiscal Research andterm.
developmentcosts

We can understand the development
capability and the efficiency of
screening test in early stages of thenew drug research and development
pipeline.

Provided once a year (Future) sales
according to the fiscalterm.

We can plan for a managerial
resource allocation by discoveringstrong areas of internal research anddevelopment according to nature ofpatents.

Provided once a year Research andaccording to the fiscal development
term.
costs,(Future) sales

We can take early actions for the next
reseach and development (R&D) planby understanding the effect of strategic
allignment of area portfolio and theefficiency from R&D project status foreach therapeutic area.

Provided once a year Research andaccording to the fiscal development
term.
costs,(Future) sales

We can take early actions for the next
reseach and development (R&D) planby understanding the effect of strategic
allignment of area portfolio and theefficiency from R&D project status foreach therapeutic area.

Sample Business Case:
Provided once a year (Future) sales
ABC company closed 305 contracts with XYZ Contract Research Organization (CRO) and only 246 were according to the fiscal
executed.
term. The higher therate, the better theClinical test rate
Contracted
performance.
ProjectⅠ
ⅡⅢ
Ⅳ
number of cases
RCRC
R C R C100%
100% 80%

We can sort out the relationship status
with Contract Research Organization(CRO) looking at the clinical execution
rate.

Number ofAreas

Definition of unmet needs

Areas

Unmet medical needs

Thrombosis, cancer, diabetes, autoimmune disease/rheumatoid

Breakdown the results of screening for theSample Business Case: ABC company
chemical compounds which entered to preclinicalAnatomical Therapeutic Chemical (ATC)phase by therapeutic categories.
Classification System
Nervous system & Sensory organ drugs
Each organ drugs
Metabolic drugs
Stem cell drugs

Number ofdrug candidates

4Previous
3-year average

Reference: Wikipedia (Japanese)
To understand the development
capability of new medicine(Number of substance patents/Total patents)×100 Sample Business Case: ABC company

Substance Process UsageTotalOthers
patents patents patents
patents

Number of Patents
3 &SubstancePatents Ratio

Numberof patents

1528322297

Allowance rate of substance patents = (15/97)×100

4R&D ratio by
Therapeutic Area

To understand the strength of Pipeline, Breakdown the R&D expenses for the year by
Progress of R&D
therapeutic areas and the phases ( preclinical,clinical, alliance) and divided by total R&D
expenditure. Disclose with the accumulated
amount for the past 5 years.

Sample Business Case: ABC company(Unit: JPY 100 million)
Therapeutic Non-clinical Clinical practice rate Rate for Accumulated amountareas
practice rate Ⅰ Ⅱ Ⅲ Ⅳ alliances
for last 5 years
Diabetes

To assume the aggressiveness of R&D Breakdown the licensing expenses for the year by Sample Business Case: ABC company(Unit: JPY 100 million)
activities for other geographical areas areas and the phases ( preclinical, clinical,besides Japan and the result of R&Dalliance) and divided by total R&D expenditure.
Locations Non-clinical Clinical practice rate Rate for Accumulated amount
Disclosewiththeaccumulated
amountforthepractice rate Ⅰ Ⅱ Ⅲ Ⅳ alliancesfor last 5 years
Number of Licensing by
5U.S.
past
5years.
AreaEurope

To assume the driving power for clinical Number of implemented cases/total cases =test
implementation ratio for top 10 items

6

Number of Test Cases
by Project

R (Recruiting): participants are currently being recruited
C (Completed): the study has concluded normally; participants are no longer being examined ortreated(i.e., last patient's last visit has occurred)© 2010 WICI Japan all rights reserved.

No.

KPI

Description

KPI formula

To understand the R&D success rate by number of chemical compounds at the stage÷
the transition ratio from the previous
number of chemical compounds at the previous
phasestage ×accumulated successful rate
R&D Success Rate for
7 Therapeutic area andPhase

Market Shares for
8 Popular Products（byArea）

To know which country or area theCompany obtains the market strengthand how the company deploy theirmarket in global market.

Revenue of popular items÷Market Share

Area: Diabetes

Clinical phase
Number ofⅡⅢ
Ⅳ applications
1210970.75 0.833 0.90.770.75 0.625 0.560.43

Preliminarypatents

Number of areas where company deploys
laboratories

Breakdown the projects into local and global
areas

Locations

Rate intotal sales

JapanU.S.

Locations
U.S.
EuropeJapan
Developing countries

Existance of officesy/yDevelopment
Clinical researchInternal
External(CRO)
Research○○○
Open two offices
××
×
Close one office
○
○
○
○
×
×

Sample Business Case: ABC company

Object locations
GlobalLocal

11 License Ratio by Area

We can plan for a managerial
resource allocation by identifying acompany's development capacity fromthe success rate trends in researchand development projects.

Provided once a year (Future) salesaccording to the fiscal Rate of returnterm.

We can study the effects on drop insales by the number of off-patent
drugs and plan next strategies as soon
as drugs go off patent.

Provided once a year Sales
according to the fiscalterm.

We can plan competitive strategies
and verify if the past competitive
strategies were successful.

Provided once a year (Future) sales,
according to the fiscal Research andterm.
development
costs

Figuring out the research anddevelopment system such as global
drug discovery infrastructure, clinicalresearch infrastructure and so on, we
can make an optimized research anddevelopment investment plan which isfocused on future senario of globaldevelopment.

Provided once a year (Future) sales,
according to the fiscal Research andterm.
developmentcosts

We can make a managerial resource
allocation plan which is focused on
future senario of global development
by understanding capability of drug
discovery infrastructure, clinicalresearch infrastructure and so on ofeach area.

Provided once a year Sales (in-licensed
according to the fiscal products sales)
term. The contract
type must be written.

We can plan further sales promotion
strategies for corporate/organizationalalignment by identifying patent usage
in locations where there is no sales
channel.

Sales
Market share
1,500
19%
1,500
13%
2,000
40%
1,500
13%

Sample Business Case: ABC company(Basic research: 4 areas, clinical research: 3 areas, development research: 3 areas)

Basicresearch
U.S.
○Europe×Japan○Developing countries○
Breakdown the number of licenses into areas
where company has sales rights and divide bytotal license

Market size
8,000
12,0005,000
12,000

Number of projects
70%
30%

Breakouts of local areas can be indicated in the appendix.
To specify the pipelines which need to Breakdown the number of license-in items by
be reinforced and to understand thetherapeutic areas into developed products andtherapeutic areas which the Company's undeveloped products.
main focus.

12

License-In Ratio by
Therapeutic Area

© 2010 WICI Japan all rights reserved.

Sample Business Case: ABC company

License agreement ratio
In orProducts
Out Merchandisesy/y(unlicensed)
InGlobal
OutInU.S.
OutInJapan
OutDeveloping Incountries OutLocations

Merit/Need

Provided once a year (Future) sales
according to the fiscalterm. The higher therate, the better theperformance.

Off-patent period
1 year < X < 3 years 3 years < X < 5 years
Item FF(Unit: JPY 100

Locations

Project Ratio byTargeted Area

X<1Item BB

Relation withFinancials

60.85
0.37

Sample Business Case: ABC company (sorted by areas)

Areas

Number of Deployment
Areas for R&D Basis

To understand the aggressiveness of
Global Deployment

Number ofapproved

Note: The off-patent date deffers by areas.

Nerve

10Ⅰ16

Sample Business Case: ABC company

ATo understand the aggressiveness ofglobal Deployment

Application Date

Sample Business Case: ABC company

Chemical compounds
Success rate
Cumulative success rate

To understand the aggressiveness ofglobal Deployment

9

Practice Example

No.

Description

KPI formula

To understand the utilization of inhouse patents and the earnings modelby intellectual properties

Breakdown the number of license-out items by
therapeutic areas into developed products andundeveloped products.

KPI

Practice Example
Sample Business Case: ABC company

Therapeutic License agreement ratio
GrossProductsareas
Merchandisesinterest(unlicensed)
5%40%%/ %
Diabetes
13%
50%%/ %
Nerve

License-Out Ratios by13Contract Object

Application Date

Relation withFinancials

Merit/Need

Provided once a year Sales (areaaccording to the fiscal license-out fees)
term. The contract
type must be written.

We can design further sales promotion
strategies or portfolio strategies to use
intellectual assets by recognizing not
only product sales but also patent
usage.

Provided once a year
according to the fiscal
term. The contract
type must be written.

We can design further sales promotion
strategies to use intellectual assets byrecognizing not only product sales but
also patent usage.

y/y-2%/5%+3%/-4%

Therapeutic areas deffers depending on each company.

To understand the quality of researcher Breakdown the number of accepted literatures for Sample Business Case: ABC company
major journals by therapeutic areas.
Sales promotion objectives: total number of products and pipelines = 10 (License-out(L.O.) = 4)

Number of license agreements
Products
Contract type
Merchandisesy/y(unlicensed)
Sales promotion
10%55%-2%/5%
15%40% +3%/-4%

Number of Accepted
14 Literatures by
Therapeutic Area

To understand the strength of pipeline

Breakdown the number of patents due to expire(within next 1 year, 3 years, and 5 years)

Sample Business Case: ABC company

1996-2000

Number of patents dueto expire( within next 115year, 3 years, and 5years)

Non-clinical research
Clinical research

To understand the MR's informative
ability and sales negotiation
Ratio of MR（generalist)
16by Item© 2010 WICI Japan all rights reserved.

Breakdown the number of MR Generalists byitems. (Define MR generalist as MR who is incharge of more than 10 items for this KPIpurpose)

2000-2004
2
1

Sample Business Case: ABC company

Items

Rate of MR (G) for 3-year average
the current year
MR (G) rate

13Sales (outlicensing revenue)

Provided data of last Nonefive rolling years oncea year according tothe fiscal term.

We can identify good researchers andunderstand strengths and weaknesses
by area.

Provided once a year Sales,
according to the fiscal Labor coststerm.

We can prove the capability of theinformation provision as the result ofshares gain.