Академический Документы
Профессиональный Документы
Культура Документы
Compound Success
Rates by Stage
5,000-10,000
screened
Discovery
(2-10 Years)
250
enter preclinical testing
Preclinical Testing
5
enter clinical testing
Phase I
20-80 healthy volunteers used to
determine safety and dosage
Phase II
100-300 patient volunteers used
to look for efficacy and side effects
Phase III
FDA Review/
Approval
Additional
Post-marketing Testing
0
Years
10
12
14
16
13
Davanriks Potential
Cash Flows
Phase I
Phase II
(clinical testing)
Phase III
Tested on
20-80 healthy
volunteers
100-300
of patient volunteers
1000-5000 of
patients
Tested for
Safety
Effectiveness
Potential side effect
Time taken
2 years
2 years
3 years
Cost
$30 million
$40 million
Depression: 200 mn
Weight loss: $150 mn
Both: $500 mn
Initial fee /
Milestone fee
to LAB
$5 million
$2.5 million
Depression: 20 mn
Weight loss: $10 mn
Both: $40 mn
14
Davanriks Potential
Cash Flows
Phase I
Chance of
success
60%
Phase II
(clinical testing)
Phase III
15
Davanriks Potential
Cash Flows
Depression only
Both
Cost to launch
$250 million
$100 million
$400 million
Commercialization
present value
$1.2 billion
$345 million
$2.25 billion
All cash flows are expressed as after-tax present values discounted to time zero,
including capital expenditures
Present value is calculated as the after-tax present value of 10 years worth of
cash flows from the drug discounted back to today. It was believed that after 10 years,
the drug had very little value to the company since it would be off its patent by then
(and thus a terminal value of zero was used in the calculations)
16
20
21
Decision Alternatives
Decision Alternatives
Phase I
(Safety)
Phase II
(Efficacy)
Phase III
(Long Term Use)
Success
Depression
Success
Failure
Weight loss
Failure
Both
Failure
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In-License
Both
Depression
Weight loss
Do not License
85%
Phase III: Failure
15%
Phase III: Success
Phase I: Success
40%
Do not License
70%
Depression
15%
Phase III: Success
5%
Phase III: Failure
Phase I: Failure
Both
70%
60%
In-License
75%
10%
Weight loss
-$200
-$250
-$150
-$40
In-License
70%
5%
15%
-$500
Phase I: Failure
40%
Do not License
-$0
-$0
70%
10%
-$0
Depression
-$250
5%
-$100
Phase III: Failure
Phase II: Failure
Both
-$400
-$30
Phase I: Success
60%
-$100
-$0
Weight loss
-$200
-$250
$1,200
-$150
-$40
In-License
70%
5%
-$30
-$400
15%
-$500
-$250
-$0
70%
10%
-$0
$345
Phase I: Success
60%
-$100
-$0
Both
$2,250
Depression
$1,200
Weight loss
$345
85%
Phase III: Failure
15%
Phase III: Success
Phase I: Success
70%
60%
In-License
75%
70%
40%
10%
5.10%
0.90%
6.75%
2.25%
Both
2.10%
Depression
0.45%
Weight
loss
0.15%
0.30%
42%
Total = 100%
-$200
-$250
$1,200
-$270
15%
-$0
Phase III: Success
75%
-$150
25%
-$0
Phase III: Success
-$40
In-License
70%
5%
-$400
-$30
15%
-$500
-$250
-$0
70%
-$30
10%
-$0
$345
Phase I: Success
60%
-$100
-$70
-$0
$680
$25
-$220
Both
$1280
$2,250
Depression
$380
$1,200
Weight
loss
-$325
$345
-$570
-$200
-$250
$1,200
-$2.4
15%
-$0
Phase III: Success
75%
-$150
-$40
In-License
5%
-$30
70%
-$400
15%
-$500
-$250
-$0
70%
-$12.0
$1.7
$345
-$5.0
25%
-$0
Phase III: Success
Phase I: Success
60%
-$100
10%
-$0
$34.7
Both
$26.90
$2,250
Depression
$1.7
$1,200
Weight
loss
-$0.5
$345
-$1.7
-$0-$29.4
Total = $14.0
Davanriks Probability
Phase
I
II
III Depression
III Weight Loss
III Dual Indication
Total
40%
60% x 70%
60% x 10% x 15%
60% x 15% x 25%
60% x 5% x 10%
40.00%
42.00%
0.90%
2.25%
0.30%
85.45%
Probability
Expected
Milestone
Payment
Initial
$5.00
100%
$5.0
Phase I Success
2.50
60%
1.5
Phase II Depression
20.00
60% x 10%
1.2
10.00
60% x 15%
0.9
60% x 5%
1.2
9.8
34
5.10
$3.22
6.75
1.23
1263
0.45
0.28
363
0.15
0.03
Dual Claim
2368
2.10
2.49
14.55
7.25
Total
$1263
35
Sensitivity analysis
Scenario analysis
Certainty equivalent model
Decision tree analysis
Break even analysis
Simulation
Risk adjusted discount rate
Real options
40
Decision Analysis
Logical and systematic approach for analyzing decision
problems
Steps.,
Identify criteria for choosing among competitive alternatives
Structure decision problem, listing alternatives and uncertain events in
chronological order and representing them in a decision tree
Assess the likelihood of the various uncertain events and assign values
to the various outcomes of the decision problem
Analyze the information provided in the first three steps to determine
which alternative to undertake
Determine if the decision is sensitive to changes in probabilities or
other assumptions you have made
41
Decision Tree
Chronological sequence of options and uncertain events in a
decision tree
Maximizing expected monetary value (EMV)
EMV = probability * net cash flow
Outcome depends on external event making it uncertain
Probabilities..,
Likelihood of uncertain events
Precise numerical language for communicating judgments about the
uncertain future
Explicit in pronouncements
Are formed based on researches
42
Decision Tree
Probability in DTA is objective
Decision method folding back the tree or backwards
induction
Deals with uncertain inputs parameter values that are
subject to uncertainty known only after a decision is made
Probability tree
Visual tool that can represent key elements in a model for
decision making under uncertainty and help organize those
elements by distinguishing between decisions (controllable
variables) and random events (uncontrollable variables)
43
Payoff Tables
Cost or revenue
Is a measure of economic result
Regret = for any state and any specific action, the regret
is the monetary difference between the best possible
payoff for that state and payoff for the specific action
Expected value = weighted average outcome, where
the weights are probabilities of each state
States in Merck decision = 2 x 2 x 4 x 8 = 128
44
Decision Tree
Risk profile = distribution associated with a particular action
Useful in situations where there are multiple sources of
uncertainty and sequence of decisions to make
Expected value of perfect information (EVPI) = measures the
difference, or the gain due to perfect information
EVPI = measures the difference between certain payoff that could be realized
under a condition of certainty and the expected payoff under a condition
involving risk
EVPI = EPC EMV
EPC = expected payoff under certainty
45
Estimated values
Profits revenues costs other measure of value
May be monthly daily yearly weekly
May be present value of future cash flows
46
47
48
Duration - Example
Discount Rate
Time
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
8%
4
$160
200
350
395
432
440
442
444
446
448
450
451
451
452
(2,000)
CF
5
280
280
280
280
280
280
280
280
280
280
280
280
280
280
280
8
($350)
(60)
60
350
700
1,200
2,250
NPV
4
148.15
171.47
277.84
290.34
294.01
277.27
257.90
239.88
223.11
207.51
193.00
179.10
165.83
153.89
-630.48
2448.82
448.82
PVCF
5
259.26
240.05
222.27
205.81
190.56
176.45
163.38
151.28
140.07
129.69
120.09
111.19
102.96
95.33
88.27
2396.65
tPVCF
8
4
5
8
-324.07
148
259
-350
-51.44
343
480
-120
47.63
834
667
180
257.26
1161
823
1400
476.41
1470
953
3500
756.20
1664
1059
7200
1312.85
1805
1144
15750
1919
1210
2008
1261
2075
1297
2123
1321
2149
1334
2156
1338
2154
1335
-9457
1324
2474.84 12552.27 15804.64 27560.00
Duration
5.13
6.59
11.14
396.65
474.84
49