Appendix
Appendix 1: Danish Corporate Tax Rate .............................................................................. 72
Appendix 2: Richard Lynch’s Approach to Strategic Analysis ..................................... 72
Appendix 3: Calculation of the Risk Adjusted NPV Example ....................................... 73
Appendix 4: Crystal Ball sheets (LCP-Tacro): US, Europe and Japan ....................... 74
Appendix 5: Monto Carlo Simulation Output ..................................................................... 77
Appendix 6: The Binomial Latices (US, Europe and Japan) .......................................... 78
Appendix 7: Veloxis’ Stock Price Development ................................................................. 81
Appendix 8: Phase I & Phase II results ................................................................................. 82
Appendix 9: Results from the phase III Clinical Trials ................................................... 83
Appendix 10: Planed Structure of the US Sales Force .................................................... 86
Appendix 11: Daily Dosage of Tacrolimus per Kg of Body Weight ............................ 87
Appendix 12: Average Body Weight by World Region ................................................... 88
Appendix 14: Estimation of the Yearly Price of Tacro in US, Europe and Japan .. 89
Appendix 15: Tacrolimus (Prograf) Sales in the Period 2006-2008 ........................ 91
Appendix 16: US Kidney Transplant Opportunity (Veloxis’ Projections) ............... 92
Appendix 17: Tiered Royalties by Stage of Development ............................................. 93
Appendix 18: Estimation of the Risk-Free Rate ................................................................ 93
Appendix 19: Beta Estimation ................................................................................................. 94
Appendix 20: DCF Model for the US Market (Tacro) ...................................................... 95
Appendix 21: Risk Adjusted Deferred Tax Asset .............................................................. 98
Appendix 22: Estimation of no. of Patients on Tacro in the 3 Markets.................... 99
Appendix 23: Estimation of Inflation .................................................................................. 101
Appendix 24: Pool of Patients with Kidney Transplant (2011) & US Tacrolimus
............................................................................................................................................................ 102
71
Appendix 1: Danish Corporate Tax Rate
Corporate Tax Rate Denmark
2013
25%
2014
24,5%
2015
23,5%
2016+
22%
Source: http://www.ft.dk/samling/20121/lovforslag/L218/index.htm
(Law no. 792 of June 28th 2013)
Appendix 2: Richard Lynch’s Approach to Strategic Analysis
Richard Lynch's Approach to the Strategic Analysis
Society
* National & international economy
* Technology
* Political factors
* Sociological factors
* Demographic structures
Industry
* Suppliers
* Customers
* Competitors
Company
Source: Schack 2009
72
Appendix 3: Calculation of the Risk Adjusted NPV Example
Consider the development of a drug compound, which recently successfully completed phase
I. Assume the empirical findings regarding the probabilities of clinical success (section
3.4.1), matches the risk of the compound. Further, it is assumed that the PV of the CF’s is
260, and that PV of the future development costs is 130.
Based on these information, the calculation of the risk adjusted NPV is presented below:
Example of how to calculate the risk-adjusted NPV
Probabilities of clinical sucess
Phase II
Phase III
Approval
56,3%
64,2%
71,0%
PV of Cash Flows
260
PV of estimated development costs
130
Cummulative probability of clinical success
25,7%
(=56.3%*64.2%*70.0%)
Risk Adjusted NPV
-63,3
(=(260*25.6%)-130)
Source: Own contribution
73
Appendix 4: Crystal Ball sheets (LCP-Tacro): US, Europe and Japan
Inputs
Tax rate
WACC
Market share
Margin
Risk free rate
Exchange rate
Inflation
2013
25%
7,46%
12,5%
50%
1,41%
5,632
2,13%
2014
24,5%
2015
23,5%
2016+
22%
Crystal Ball DCF (US)
2015
185.117
157.349
11%
2016
187.893
159.709
24%
2017
190.712
162.105
38%
2018
193.572
164.537
56%
2019
196.476
167.005
74%
2020
199.423
169.510
88%
2021
202.415
172.052
97%
2022
205.451
174.633
100%
2023
208.533
177.253
100%
2024
211.661
179.911
100%
2025
214.835
182.610
91%
2026
218.058
185.349
62%
2027
221.329
188.130
41%
2028
224.649
190.951
25%
2029
228.019
193.816
16%
2030
231.439
196.723
12%
2031
234.910
199.674
6%
∑r
LN(Vt+1/Vt)
-36,8%
Patients on LCP-Tacro
Lowest no. of patients
2.164
865
8,0
N/A
2.164
-36,8%
80%
0,80
4.791
1.917
8,0
-36,8%
47%
0,47
7.700
3.080
8,0
-36,8%
40%
0,40
11.518
4.607
8,0
-36,8%
29%
0,29
15.448
6.179
8,0
-36,8%
19%
0,19
18.646
7.458
8,0
-36,8%
11%
0,11
20.861
8.345
8,0
-36,8%
5%
0,05
21.829
8.732
8,0
-36,8%
1%
0,01
22.157
8.863
8,0
-36,8%
1%
0,01
22.489
8.996
8,0
-36,8%
-8%
-0,08
20.772
8.309
8,0
-36,8%
-37%
-0,37
14.365
5.746
8,0
-36,8%
-40%
-0,40
9.642
3.857
8,0
-36,8%
-48%
-0,48
5.967
2.387
8,0
-36,8%
-43%
-0,43
3.876
1.551
8,0
-36,8%
-27%
-0,27
2.951
1.180
8,0
-36,8%
-68%
-0,68
1.498
599
8,0
Patients on immunosuppression
Patients on tacrolimus
Penetration index
2*sqr(16)
st dev
Patients on LCP-Tacro in the simulation
∑r
LN(Vt+1/Vt)
33,7%
LCP-Tacro yearly price (DKK)
Lowest yearly price for LCP-Tacro (DKK)
2*sqr(16)
st dev
LCP-Tacro yearly price in simulation (DKK)
51.463
38.597
8,0
N/A
51.463
Revenue (DKK m)
∑r
LN(Vt+1/Vt)
Costs
Lowest possible costs (DKK m)
2*sqr(16)
st dev
Yearly costs in simulation (DKK m)
55,7
44,5
8,0
N/A
55,7
Profits (DKK m)
Proftis after tax (DKK m)
Time factor
Discount factor
PV of CF (DKK m)
Sum of PV of CF's (DKK m) (2013)
Sum of PV of CF's (DKK m) (2013)
56
43
2,5
0,84
35,6
2.400,1
2.400,1
PV of CF's (DKK m) (2014)
2579,2
LN(PV2014/PV2013)
0,0720
0,069
0,069
0,069
0,069
0,069
0,069
0,069
0,069
0,069
0,069
0,069
0,069
0,069
0,069
0,069
0,069
4.791
7.700
11.518
15.448
18.646
20.861
21.829
22.157
22.489
20.772
14.365
9.642
5.967
3.876
2.951
1.498
33,7%
2,1%
0,021
52.558
39.419
8,0
33,7%
2,1%
0,021
53.677
40.258
8,0
33,7%
2,1%
0,021
54.820
41.115
8,0
33,7%
2,1%
0,021
55.987
41.990
8,0
33,7%
2,1%
0,021
57.178
42.884
8,0
33,7%
2,1%
0,021
58.395
43.797
8,0
33,7%
2,1%
0,021
59.638
44.729
8,0
33,7%
2,1%
0,021
60.908
45.681
8,0
33,7%
2,1%
0,021
62.204
46.653
8,0
33,7%
2,1%
0,021
63.528
47.646
8,0
33,7%
2,1%
0,021
64.881
48.660
8,0
33,7%
2,1%
0,021
66.262
49.696
8,0
33,7%
2,1%
0,021
67.672
50.754
8,0
33,7%
2,1%
0,021
69.113
51.834
8,0
33,7%
2,1%
0,021
70.584
52.938
8,0
33,7%
2,1%
0,021
72.086
54.065
8,0
0,078
0,078
0,078
0,078
0,078
0,078
0,078
0,078
0,078
0,078
0,078
0,078
0,078
0,078
0,078
0,078
52.558
53.677
54.820
55.987
57.178
58.395
59.638
60.908
62.204
63.528
64.881
66.262
67.672
69.113
70.584
72.086
111,3
251,8
413,3
631,4
864,9
1.066,2
1.218,2
1.301,9
1.349,5
1.398,9
1.319,6
932,0
638,9
403,8
267,9
208,3
108,0
-3,1%
-3,1%
0,82
0,82
125,9
100,7
8,0
-3,1%
0,50
0,50
206,7
165,3
8,0
-3,1%
0,42
0,42
315,7
252,6
8,0
-3,1%
0,31
0,31
432,4
346,0
8,0
-3,1%
0,21
0,21
533,1
426,5
8,0
-3,1%
0,13
0,13
609,1
487,3
8,0
-3,1%
0,07
0,07
650,9
520,7
8,0
-3,1%
0,04
0,04
674,8
539,8
8,0
-3,1%
0,04
0,04
699,5
559,6
8,0
-3,1%
-0,06
-0,06
659,8
527,8
8,0
-3,1%
-0,35
-0,35
466,0
372,8
8,0
-3,1%
-0,38
-0,38
319,4
255,5
8,0
-3,1%
-0,46
-0,46
201,9
161,5
8,0
-3,1%
-0,41
-0,41
134,0
107,2
8,0
-3,1%
-0,25
-0,25
104,1
83,3
8,0
-3,1%
-0,66
-0,66
54,0
43,2
8,0
0,024
0,024
0,024
0,024
0,024
0,024
0,024
0,024
0,024
0,024
0,024
0,024
0,024
0,024
0,024
0,024
125,9
206,7
315,7
432,4
533,1
609,1
650,9
674,8
699,5
659,8
466,0
319,4
201,9
134,0
104,1
54,0
126
98
3,5
0,78
76,3
207
161
4,5
0,72
116,6
316
246
5,5
0,67
165,8
432
337
6,5
0,63
211,3
533
416
7,5
0,58
242,4
609
475
8,5
0,54
257,7
651
508
9,5
0,50
256,3
675
526
10,5
0,47
247,2
699
546
11,5
0,44
238,5
660
515
12,5
0,41
209,4
466
363
13,5
0,38
137,6
319
249
14,5
0,35
87,8
202
157
15,5
0,33
51,6
134
104
16,5
0,31
31,9
104
81
17,5
0,28
23,1
54
42
18,5
0,26
11,1
74
Inputs
2013
25%
7,46%
12,5%
50%
1,41%
5,632
2,13%
2014
25%
2015
24%
2016+
22%
2014
105.724
8%
2015
108.367
26%
2016
111.076
57%
2017
113.853
73%
2018
116.130
88%
2019
117.872
97%
2020
119.640
100%
2021
121.435
100%
2022
123.256
100%
2023
125.105
100%
2024
126.982
98%
2025
128.886
74%
2026
130.820
52%
2027
132.782
34%
2028
134.774
18%
2029
136.795
13%
2030
138.847
6%
∑r
LN(Vt+1/Vt)
-1,5%
Patients on LCP-Tacro
Lowest no. of patients
2*sqr(16)
st dev
Patients on LCP-Tacro in the simulation
1.057
529
8
N/A
1.057
-1,5%
120,3%
120,3%
3.522
1.761
8
-1,5%
81,0%
81,0%
7.914
3.957
8
-1,5%
27,2%
27,2%
10.389
5.195
8
-1,5%
20,7%
20,2%
12.774
6.387
8
-1,5%
11,2%
11,2%
14.292
7.146
8
-1,5%
4,5%
4,5%
14.955
7.478
8
-1,5%
1,5%
1,5%
15.179
7.590
8
-1,5%
1,5%
1,5%
15.407
7.704
8
-1,5%
1,5%
1,5%
15.638
7.819
8
-1,5%
-0,5%
-0,5%
15.555
7.778
8
-1,5%
-26,6%
-26,6%
11.922
5.961
8
-1,5%
-33,8%
-33,8%
8.503
4.252
8
-1,5%
-41,0%
-41,0%
5.643
2.822
8
-1,5%
-62,1%
-62,1%
3.032
1.516
8
-1,5%
-31,1%
-31,1%
2.223
1.111
8
-1,5%
-75,8%
-75,8%
1.041
521
8
∑r
LN(Vt+1/Vt)
33,7%
LCP-Tacro yearly price (DKK)
Lowest yearly price for LCP-Tacro (DKK)
2*sqr(16)
st dev
LCP-Tacro yearly price in simulation (DKK)
40.270
26.176
8
N/A
40.270
Tax rate
WACC
Market share
Margin
Risk free rate
Exchange rate
Inflation
Crustal Ball DCF (EU)
Patients on tacrolimus
Penetration index
Revenue (DKK m)
0,085
0,085
0,085
0,085
0,085
0,085
0,085
0,085
0,085
0,085
0,085
0,085
0,085
0,085
0,085
0,085
3.522
7.914
10.389
12.712
14.222
14.882
15.105
15.332
15.561
15.479
11.864
8.462
5.616
3.018
2.212
1.036
33,7%
2,1%
2,1%
41.127
26.733
8
33,7%
2,1%
2,1%
42.003
27.302
8
33,7%
2,1%
2,1%
42.897
27.883
8
33,7%
2,1%
2,1%
43.810
28.476
8
33,7%
2,1%
2,1%
44.742
29.083
8
33,7%
2,1%
2,1%
45.695
29.702
8
33,7%
2,1%
2,1%
46.667
30.334
8
33,7%
2,1%
2,1%
47.661
30.979
8
33,7%
2,1%
2,1%
48.675
31.639
8
33,7%
2,1%
2,1%
49.711
32.312
8
33,7%
2,1%
2,1%
50.769
33.000
8
33,7%
2,1%
2,1%
51.850
33.703
8
33,7%
2,1%
2,1%
52.954
34.420
8
33,7%
2,1%
2,1%
54.081
35.153
8
33,7%
2,1%
2,1%
55.232
35.901
8
33,7%
2,1%
2,1%
56.408
36.665
8
0,096
0,096
0,096
0,096
0,096
0,096
0,096
0,096
0,096
0,096
0,096
0,096
0,096
0,096
0,096
0,096
41.127
42.003
42.897
43.810
44.742
45.695
46.667
47.661
48.675
49.711
50.769
51.850
52.954
54.081
55.232
56.408
43
145
332
446
557
636
680
705
731
757
769
602
439
297
163
122
58
Royalties
Highest possible Royalties
Lowest possible Royalties
15,0%
20%
10%
15,0%
20%
10%
15,0%
20%
10%
15,0%
20%
10%
15,0%
20%
10%
15,0%
20%
10%
15,0%
20%
10%
15,0%
20%
10%
15,0%
20%
10%
15,0%
20%
10%
15,0%
20%
10%
15,0%
20%
10%
15,0%
20%
10%
15,0%
20%
10%
15,0%
20%
10%
15,0%
20%
10%
15,0%
20%
10%
Royalties (DKK m)
Royalties after tax (DKK m)
Time factor
Discount factor
PV of CF (DKK m)
Sum of PV of CF's (DKK m) (2013)
Sum of PV of CF's (DKK m) (2013)
6,4
4,8
1,5
0,90
4,3
464,8
466,7
21,7
16,6
2,5
0,84
13,9
49,9
38,9
3,5
0,78
30,2
66,8
52,1
4,5
0,72
37,7
83,5
65,2
5,5
0,67
43,9
95,4
74,4
6,5
0,63
46,6
102,0
79,6
7,5
0,58
46,4
105,7
82,5
8,5
0,54
44,7
109,6
85,5
9,5
0,50
43,2
113,6
88,6
10,5
0,47
41,6
115,4
90,0
11,5
0,44
39,4
90,3
70,5
12,5
0,41
28,7
65,8
51,3
13,5
0,38
19,4
44,6
34,8
14,5
0,35
12,3
24,5
19,1
15,5
0,33
6,3
18,3
14,3
16,5
0,31
4,4
8,8
6,8
17,5
0,28
1,9
PV of CF's (DKK m) (2014)
499,5
LN(PV2014/PV2013)
0,0680
75
Inputs
Tax rate
WACC
Market share
Margin
Risk free rate
Exchange rate
Inflation
2013
25%
7,46%
12,5%
50%
1,41%
5,632
2,13%
2014
25%
2015
24%
2016+
22%
2015
42.650
10%
2016
43.716
31%
2017
44.809
62%
2018
45.481
73%
2019
46.163
90%
2020
46.856
100%
2021
47.559
100%
2022
48.272
100%
2023
48.996
100%
2024
49.731
97%
2025
50.477
74%
2026
51.234
52%
2027
52.003
34%
2028
52.783
18%
2029
53.575
11%
2030
54.378
6%
2031
55.194
5%
-43,5%
-43,5%
115,6%
115,6%
1.355
678
8
-43,5%
71,8%
71,8%
2.778
1.389
8
-43,5%
17,8%
17,8%
3.320
1.660
8
-43,5%
22,4%
22,4%
4.155
2.077
8
-43,5%
12,0%
12,0%
4.686
2.343
8
-43,5%
1,5%
1,5%
4.756
2.378
8
-43,5%
1,5%
1,5%
4.827
2.414
8
-43,5%
1,5%
1,5%
4.900
2.450
8
-43,5%
-1,6%
-1,6%
4.824
2.412
8
-43,5%
-25,6%
-25,6%
3.735
1.868
8
-43,5%
-33,8%
-33,8%
2.664
1.332
8
-43,5%
-41,0%
-41,0%
1.768
884
8
-43,5%
-62,1%
-62,1%
950
475
8
-43,5%
-47,8%
-47,8%
589
295
8
-43,5%
-59,1%
-77,4%
326
163
8
-43,5%
-16,7%
1,5%
276
138
8
0,032
Crystal Ball DCF (JAP)
Patients on tacrolimus
Penetration index
∑r
LN(Vt+1/Vt)
Patients on LCP-Tacro
Lowest no. of patients
2*sqr(16)
st dev
Patients on LCP-Tacro in the simulation
426
213
8
N/A
426
∑r
LN(Vt+1/Vt)
33,7%
LCP-Tacro yearly price (DKK)
Lowest yearly price for LCP-Tacro (DKK)
2*sqr(16)
st dev
LCP-Tacro yearly price in simulation (DKK)
34.643
22.518
8
N/A
34.643
Revenue (DKK m)
0,032
0,032
0,032
0,032
0,032
0,032
0,032
0,032
0,032
0,032
0,032
0,032
0,032
0,032
0,032
1.355
2.778
3.320
4.155
4.686
4.756
4.827
4.900
4.824
3.735
2.664
1.768
950
589
272
276
33,7%
2,1%
2,1%
35.380
22.997
8
33,7%
2,1%
2,1%
36.133
23.487
8
33,7%
2,1%
2,1%
36.903
23.987
8
33,7%
2,1%
2,1%
37.688
24.497
8
33,7%
2,1%
2,1%
38.490
25.019
8
33,7%
2,1%
2,1%
39.310
25.551
8
33,7%
2,1%
2,1%
40.146
26.095
8
33,7%
2,1%
2,1%
41.001
26.651
8
33,7%
2,1%
2,1%
41.874
27.218
8
33,7%
2,1%
2,1%
42.765
27.797
8
33,7%
2,1%
2,1%
43.675
28.389
8
33,7%
2,1%
2,1%
44.605
28.993
8
33,7%
2,1%
2,1%
45.554
29.610
8
33,7%
2,1%
2,1%
46.524
30.241
8
33,7%
2,1%
2,1%
47.514
30.884
8
33,7%
2,1%
2,1%
48.526
31.542
8
0,096
0,096
0,096
0,096
0,096
0,096
0,096
0,096
0,096
0,096
0,096
0,096
0,096
0,096
0,096
0,096
35.380
36.133
36.903
37.688
38.490
39.310
40.146
41.001
41.874
42.765
43.675
44.605
45.554
46.524
47.514
48.526
15
48
100
123
157
180
187
194
201
202
160
116
79
43
27
13
13
12,5%
15%
10%
12,5%
15%
10%
12,5%
15%
10%
12,5%
15%
10%
12,5%
15%
10%
12,5%
15%
10%
12,5%
15%
10%
12,5%
15%
10%
12,5%
15%
10%
12,5%
15%
10%
12,5%
15%
10%
12,5%
15%
10%
12,5%
15%
10%
12,5%
15%
10%
12,5%
15%
10%
12,5%
15%
10%
12,5%
15%
10%
Royalties (DKK m)
Royalties after tax (DKK m)
Time factor
Discount factor
PV of CF (DKK m)
Sum of PV of CF's (DKK m) (2013)
Sum of PV of CF's (DKK m) (2013)
1,8
1,4
2,5
0,84
1,2
93,2
93,3
6,0
4,7
3,5
0,78
3,6
12,5
9,8
4,5
0,72
7,1
15,3
11,9
5,5
0,67
8,0
19,6
15,3
6,5
0,63
9,6
22,5
17,6
7,5
0,58
10,3
23,4
18,2
8,5
0,54
9,9
24,2
18,9
9,5
0,50
9,5
25,1
19,6
10,5
0,47
9,2
25,2
19,7
11,5
0,44
8,6
20,0
15,6
12,5
0,41
6,3
14,5
11,3
13,5
0,38
4,3
9,9
7,7
14,5
0,35
2,7
5,4
4,2
15,5
0,33
1,4
3,4
2,7
16,5
0,31
0,8
1,6
1,3
17,5
0,28
0,4
1,7
1,3
18,5
0,26
0,3
PV of CF's (DKK m) (2014)
100,2
LN(PV2014/PV2013)
0,0712
Royalties
Highest possible Royalties
Lowest possible Royalties
76
Appendix 5: Monto Carlo Simulation Output
Crystal Ball Output: (US) Volatility of the Project
è
:
Source: Own contribution
Crystal Ball Output: (Europe) Volatility of the Project
è
Source: Own contribution
Crystal Ball Output: (Japan) Volatility of the Project
è
Source: Own contribution
77
Appendix 6: The Binomial Latices (US, Europe and Japan)
Binomial Lattice (US)
NDA
2013
Q3
Volatility
Up Factor
Down Factor
Q4
2014
Q1
Q2
0,685
1,408
0,710
Q3
Q4
13300
9443
6705
4761
3380
2400
6705
4761
3380
2400
3380
2400
1704
1704
1210
1704
1210
859
859
610
433
Compound Option
NDA
2013
Q3
Querterly Discount Rate
Risk Neutral Probabilities, Q
(1-Q)
Q4
2014
Q1
Q2
1,004
0,420
0,580
Q3
Q4
8818
6215
4368
3056
2124
1463
4366
3055
2123
1462
2122
1461
993
992
659
991
658
421
420
253
133
Compound Option
NDA
2013
Q3
PV of NDA filing costs
PV of launch costs
Probabilities
Value of Option
Risk adjusted static NPV
Total value
Q4
2014
Q1
Q2
Q3
Q4
236,4
68%
79,6
1383,7
1463,3
78
Binomial Lattice (Europe)
NDA
2013
Q3
Volatility
Up Factor
Down Factor
Q4
2014
Q1
Q2
0,670
1,398
0,715
Q3
Q4
2490
1782
1275
912
652
467
1275
912
652
467
652
467
334
334
239
334
239
171
171
122
87
Compound Option
NDA
2013
Q3
Querterly Discount Rate
Risk Neutral Probabilities, Q
(1-Q)
Q4
2014
Q1
Q2
1,0035
0,422
0,578
Q3
Q4
1681
1203
860
616
440
315
860
616
440
315
440
315
225
225
161
225
161
115
115
83
59
Costs and Probabilities
NDA
2013
Q3
PV of NDA filing costs
PV of launch costs
Probabilities
Value of Option
Risk adjusted static NPV
Total value
Q4
2014
Q1
Q2
Q3
Q4
68%
0,0
315,0
315,0
79
Binomial Lattice (Japan)
NDA
2013
Q3
Volatility
Up Factor
Down Factor
Q4
2014
Q1
2015
Q2
Q3
0,722
1,435
0,697
Q4
Q1
Q2
1169
814
568
396
276
276
192
134
93
192
134
276
192
134
93
65
568
396
93
65
134
93
65
45
45
32
65
45
32
22
32
22
15
15
11
7
Compound Option
NDA
2013
Q3
Querterly Discount Rate
Risk Neutral Probabilities, Q
(1-Q)
Q4
2014
Q1
2015
Q2
Q3
1,0035
0,415
0,585
Q4
Q1
Q2
789
550
383
267
186
186
30
17
9
130
90
186
130
90
7
3
383
267
63
44
90
63
44
0
31
21
44
31
21
15
21
15
10
10
7
5
Compound Option
NDA
2013
Q3
PV of NDA filing costs
PV of launch costs
Probabilities
Value of Option
Risk adjusted static NPV
Total value
Q4
2014
Q1
40,5
0
33%
2015
Q2
Q3
Q4
Q1
Q2
68%
28,2
-19,5
8,7
80
Appendix 7: Veloxis’ Stock Price Development
Veloxis' Stock Price Development (DKK), (Aug 2nd 2013-Jul 31st 2013) & (Nov 13th 2006-Jul31st 2013)
1,4
1,2
1
0,8
0,6
0,4
2013-07-02
2013-06-02
2013-05-02
2013-04-02
2013-03-02
2013-02-02
2013-01-02
2012-12-02
2012-11-02
2012-10-02
2012-09-02
2012-08-02
2012-07-02
2012-06-02
2012-05-02
2012-04-02
2012-03-02
2012-02-02
2012-01-02
2011-12-02
2011-11-02
2011-10-02
2011-09-02
0
2011-08-02
0,2
Veloxis' Stock Price Development (DKK) (Aug 2nd 2013 - Jul 31st 2013)
70
60
50
40
30
20
10
0
2006-11-13
2007-11-13
2008-11-13
2009-11-13
2010-11-13
2011-11-13
2012-11-13
Veloxis' Stock Price Development (DKK) (Nov 13th 2006 - Jul 31st 2013)
Source: Euroinvester.dk
81
Appendix 8: Phase I & Phase II results
Phase I+II resutls: Clinical Profile of LCP-Tacro vs Prograf or Advagraf
Source: Investor Presentation Q1 2008
Phase I+II resutls: Clinical Profile of LCP-Tacro vs Prograf or Advagraf
Source: Interim Report, 1st quarter 2009
82
Appendix 9: Results from the phase III Clinical Trials
Study 3001 – Stable “Switch” Study
Phase III: Study 3001 - Stable "Switch" Study
Source: Company Presentation Feb 14th 2012
83
Study 3002 – “de novo” Study
Phase III: Study 3002 - "de novo" Study
Source: Study Presentation Jun 27th 2013
84
Study 3003 – Strato Tremor Study
Phase III: Study 3003 - Strato Tremor Study
Source: Study Presentation May 20th 2013
Three studies show the same results
Comparison of Three Clinical Trials
Source: Study Presentation Jun 27th 2013
85
Appendix 10: Planed Structure of the US Sales Force
Planed Structure of the US Sales Force
Source: Inverstor Presentation Feb 14th 2012, p22
86
Appendix 11: Daily Dosage of Tacrolimus per Kg of Body Weight
Daily Dose of Tacrolimus: Statement From Pharmacists
Dr. Ogbru, pharmacist, CEO, and founder of RxEconsult, LLC:
DOSING: Oral tacrolimus is taken twice daily. Starting doses range between 0.075
mg/kg/day to 0.2 mg/kg/day. Doses vary widely and are based on tests that measure
the amount of tacrolimus in the blood. Taking tacrolimus with food can reduce some of
the abdominal pain that can occur with this medicine; however, food can reduce the
amount of tacrolimus that is absorbed. This is especially true with fatty foods. Capsules
should be taken consistently with or without food in order to avoid major swings in
blood levels. Grapefruit juice increases blood levels of tacrolimus and should be
avoided. The injection is only used for patients who cannot tolerate tacrolimus capsules.
Source: http://www.medicinenet.com/tacrolimus/article.htm
Tacrolimus Dosing Study: In American Patients
Source: http://www.rxlist.com/prograf-drug/indications-dosage.htm
87
Appendix 12: Average Body Weight by World Region
Avg. Body Weights
Female
Male
Total
Adjusted for
children
US
Europe
R.O.W.
75.6 kg
N/A
N/A
88.9 kg
N/A
N/A
82.3 kg
70.8 kg
60.0 kg
80.0 kg
68.5 kg
57.7 kg
Sources: www.cdc.gov/nchs/fastats/bodymeas.htm &
Walpole, Sarah Catherine et al; The weight of nations: an estimate of adult human biomas, 2005, p3
Population, Body Mass and Biomass by World Region in 2005
Source: Walpole, Sarah Catherine et al; The weight of nations: an estimate of adult human biomass 2005, p3
Appendix 13: Estimated Daily Dosage of Tacrolimus for Kidney Transplant Patients
Estimated Daily Dosage of Tacrolimus for Kidney Transplant Patients
Estimated avg. Daily dose = 0.1*avg. Body weight
LCP-Tacro US:
Avg. daily dosage:
Daily dosage
(mg/kg)
0,1
Avg. body
weight
80
8
mg
(mg/kg)
0,1
Avg. body
weight
68,5
6,85
mg
(mg/kg)
0,1
Avg. body
weight
57,7
5,77
mg
LCP-Tacro - Europe:
Avg. daily dosage:
Daily dosage
LCP-Tacro - Japan:
Avg. daily dosage:
Daily dosage
Source: Appendix 15 & 16
88
Appendix 14: Estimation of the Yearly Price of Tacro in US, Europe and Japan
Estimation of Yearly Price of LCP-Tacro in the US:
Exchange rate (DKK/USD)
The estimated prices are in 2013 prices
5,6324
Avg. daily dosage:
Daily dosage
Prograf
Prograf price (per mg)
Daily price
Yearly price
Generics
Generics price (per mg)
Daily price
Yearly price
Advagraf
Prograf price (per mg)
Daily price
Yearly price
(mg/kg)
0,1
Avg. body
weight
80
3,1
USD/mg
17,5 DKK/mg
140 DKK
50984 DKK
1,8
USD/mg
10,1 DKK/mg
81 DKK
29604 DKK
4
USD/mg
22,5 DKK/mg
180 DKK
65786 DKK
8 mg
As the cheaper generic version cover most of the US tacrolimus market, LCP-Tacro will be fighting with
the cheaper compounds and, the soon to be launched, Astagraf, which is expected to take over for Prograf.
LCP-Tacro is expected to be priced between the two competing products, but closest to Astagraf, as
LCP-Tacro is a branded compound. Tacro is forecasted to be priced at 3.75USD per mg.
LCP Tacro price
Daily dosage (mg/kg: 80%*0.1mg/kg)
Estimated LCP-Tacro price (per mg)
Daily price
Yearly price
(mg/kg)
0,08
3,75
Avg. body
weight
80
USD/mg
6,4 mg
21,1 DKK/mg
135 DKK
49340 DKK
89
Estimation of Yearly Price of LCP-Tacro in Europe:
Exchange rate (DKK/USD)
The estimated prices are in 2013 prices
5,6324
Avg. daily dosage:
Daily dosage
Prograf
Prograf price (per mg)
Daily price
Yearly price
Generics
Generics price (per mg)
Daily price
Yearly price
Advagraf
Prograf price (per mg)
Daily price
Yearly price
(mg/kg)
0,1
Avg. body
weight
68,5
2,9
USD/mg
16,3 DKK/mg
112 DKK
40839 DKK
1,6
USD/mg
9,0 DKK/mg
62 DKK
22532 DKK
3,7
USD/mg
20,8 DKK/mg
143 DKK
52105 DKK
6,85 mg
LCP-Tacro is expected to be priced between the prices of Prograf and Advagraf, but closest to Advtagraf, as
LCP-Tacro is a branded new compound. Tacro is forecasted to be priced at 3.5USD per mg.
LCP Tacro price
Daily dosage (mg/kg: 80%*0.1mg/kg)
Estimated LCP-Tacro price (per mg)
Daily price
(mg/kg)
0,08
3,5
Avg. body
weight
68,5
USD/mg
Yearly price
5,5 mg
19,7 DKK/mg
108 DKK
39431 DKK
Estimation of Yearly Price of LCP-Tacro in Japan:
Exchange rate (DKK/USD)
The estimated prices are in 2013 prices
5,6324
Avg. daily dosage:
Daily dosage
Prograf
Prograf price (per mg)
Daily price
Yearly price
Advagraf
Prograf price (per mg)
Daily price
Yearly price
(mg/kg)
0,1
Avg. body
weight
57,7
2,9
USD/mg
16,3 DKK/mg
94 DKK
34400 DKK
3,7
USD/mg
20,8 DKK/mg
120 DKK
43890 DKK
5,77 mg
LCP-Tacro is expected to be priced between the prices of Prograf and Advagraf, but closest to Advtagraf, as
LCP-Tacro is a branded new compound. Tacro is forecasted to be priced at 3.5USD per mg.
LCP Tacro price
Daily dosage (mg/kg: 80%*0.1mg/kg)
Estimated LCP-Tacro price (per mg)
Daily price
Yearly price
(mg/kg)
0,08
3,5
Avg. body
weight
57,7
USD/mg
4,6 mg
19,7 DKK/mg
91 DKK
33214 DKK
90
Appendix 15: Tacrolimus (Prograf) Sales in the Period 2006-2008
Tacrolimus (Prograf) Sales from 2006-2008
Source: Invester Presentation March 3rd 2009, p12
91
Appendix 16: US Kidney Transplant Opportunity (Veloxis’ Projections)
US Kidney Transplant Opportunity (Veloxis' Projections)
Source: Inverstor Presentation Feb 14th 2012, p23
Calculations Based on Veloxis' Projections
Market share
40,000/200,000
50,000/200,000
=
=
20%
25%
De novo patients
4,000/17,000
6,000/17,000
=
=
24%
35%
Source: Inverstor Presentation Feb 14th 2012, p23
92
Appendix 17: Tiered Royalties by Stage of Development
Tiered Royalties by Stage of Development
Source: http://www.lesi.org/docs/lesi-updates-and-news-documents/f
2008biopharmaceauticalroyaltyratedealterms-110108.pd
Appendix 18: Estimation of the Risk-Free Rate
Danish government bond - August 1st 2013
Expire
Coupon
Rate
Effective rate
2021
112,38
3%
1,36%
Danish government bond - August 1st 2013
Expire
Coupon
Rate
Effective rate
10 year government bond
2024
154,011
7%
1,60%
1,41%
Source: nasdaqomxnordic.com/obligationer
93
Appendix 19: Beta Estimation
Beta (Raw) Estimation Using 5 Years of Monthly Data (Outliers Removed)
Regression Statistics
Multiple R 0,28188824
R Square
0,07946098
Adjusted R Square
0,06272391
Standard Error0,13194864
Observations
57
ANOVA
df
Regression
Residual
Total
SS
MS
F
Significance F
1 0,08265788 0,08265788 4,74760316 0,03364111
55 0,95757438 0,01741044
56 1,04023225
Coefficients Standard Error
t Stat
P-value
Lower 95%
Upper 95%
Lower 95,0% Upper 95,0%
Intercept
-0,0297034 0,01756961 -1,6906107 0,09657162 -0,0649136 0,00550691 -0,0649136 0,00550691
X Variable 1 0,7020827 0,32221894 2,17889953 0,03364111 0,05634151 1,34782388 0,05634151 1,34782388
! "#$%&'(
$%. "
$%0"
! "#"$%&$' ( ) "*"$%$' +&"
, -"#"$%$&+. / "
$%' "
$%( "
2345) 67"
$"
*$%' "
*$%( 1"
*$%( "
*$%$1"
$"
$%$1"
$%( "
$%( 1"
8693: ;"<2345) 67="
*$%( "
*$%' "
*$%0"
*$%. "
94
Appendix 20: DCF Model for the US Market (Tacro)
DCF Model for the US Market
Probabilities
Approval rate
Likelyhood of refusion
Cummulative
90%
75%
68%
Inputs
Tax rate
WACC
Market share
Margin
Risk free rate
Exchange rate
Inflation
2013
25%
7,46%
12,5%
50%
1,41%
5,632
2,13%
Development costs
2013
2014
24,5%
2015
23,5%
2014
0
0
2,13%
0
0,5
0,99
0,0
236,4
0
1
2,13%
0
1,5
0,98
0,0
2015
Launch
255,3
2
2,13%
244,8
2,5
0,97
236,4
Patients on immunosuppression
Patients on tacrolimus
Penetration index
Patients on LCP-Tacro
Yearly price per patient (DKK)
Revenue (DKK m)
Profits (DKK m)
Proftis after tax (DKK m)
Time factor
Discount factor
PV of CF (DKK m)
Sum of PV of CF's (DKK m)
2015
185.117
157.349
11%
2.164
51.463
111,3
55,7
42,6
2,5
0,84
35,6
2.400,1
2016
187.893
159.709
24%
4.791
52.558
251,8
125,9
98,2
3,5
0,78
76,3
2017
190.712
162.105
38%
7.700
53.677
413,3
206,7
161,2
4,5
0,72
116,6
Risk adjusted NPV (DKK m)
1.383,7
NDA
Filing and launch associated costs
Inflation factor
Inflation
Inflation adjusted costs
Time factor
Discount factor
PV of CF's
PV of filing and launch associated costs
2016+
22%
DCF (US)
2018
193.572
164.537
56%
11.518
54.819
631,4
315,7
246,2
5,5
0,67
165,8
2019
196.476
167.005
74%
15.448
55.986
864,9
432,4
337,3
6,5
0,63
211,3
2020
199.423
169.510
88%
18.646
57.178
1.066,1
533,1
415,8
7,5
0,58
242,4
2021
202.415
172.052
97%
20.861
58.395
1.218,2
609,1
475,1
8,5
0,54
257,7
2022
205.451
174.633
100%
21.829
59.638
1.301,8
650,9
507,7
9,5
0,50
256,3
2023
208.533
177.253
100%
22.157
60.907
1.349,5
674,8
526,3
10,5
0,47
247,2
2024
211.661
179.911
100%
22.489
62.204
1.398,9
699,4
545,6
11,5
0,44
238,5
2025
214.835
182.610
91%
20.772
63.528
1.319,6
659,8
514,6
12,5
0,41
209,4
2026
218.058
185.349
62%
14.365
64.880
932,0
466,0
363,5
13,5
0,38
137,6
2027
221.329
188.130
41%
9.642
66.261
638,9
319,4
249,2
14,5
0,35
87,8
2028
224.649
190.951
25%
5.967
67.672
403,8
201,9
157,5
15,5
0,33
51,6
2029
228.019
193.816
16%
3.876
69.112
267,9
134,0
104,5
16,5
0,31
31,9
2030
231.439
196.723
12%
2.951
70.583
208,3
104,1
81,2
17,5
0,28
23,1
2031
234.910
199.674
6%
1.498
72.086
108,0
54,0
42,1
18,5
0,26
11,1
95
DCF Model for the European Market (Tacro)
DCF Model for the European Market
Probabilities
Approval rate
Likelyhood of refusion
Cummulative
90%
75%
68%
Inputs
Tax rate
WACC
Market share
Margin
Risk free rate
Exchange rate
Inflation
2013
25%
7,46%
12,5%
50%
1,41%
5,632
2,13%
2014
24,5%
2015
23,5%
2016+
22%
2014
105.724
8%
1.057
40.270
42,6
773,3
137,3
2015
108.367
26%
3.522
41.127
144,8
2016
111.076
57%
7.914
42.003
332,4
2017
113.853
73%
10.389
42.897
445,7
DCF (EU)
Patients on tacrolimus
Penetration index (Based onon section XXPLC)
Patients on LCP-Tacro
Yearly price per patient (DKK)
Revenue (DKK m)
Max Revenue (DKK m)
Max Revenue (USD m)
Royalties
15%
Royalties for Veloxis (DKK m)
Royalties after tax (DKK m)
Time factor
Discount factor
PV of CF's (DKK m)
Static NPV of CF's (DKK m)
6,4
4,8
1,5
0,90
4,3
466,7
Risk-adjusted NPV (DKK m)
315,0
2018
116.130
88%
12.774
43.810
559,6
2019
117.872
97%
14.292
44.742
639,5
2020
119.640
100%
14.955
45.695
683,4
2021
121.435
100%
15.179
46.667
708,4
2022
123.256
100%
15.407
47.661
734,3
2023
125.105
100%
15.638
48.675
761,2
2024
126.982
98%
15.555
49.711
773,3
2025
128.886
74%
11.922
50.769
605,3
2026
130.820
52%
8.503
51.850
440,9
2027
132.782
34%
5.643
52.954
298,8
2028
134.774
18%
3.032
54.081
164,0
2029
136.795
13%
2.223
55.232
122,8
2030
138.847
6%
1.041
56.408
58,7
66,1
51,6
13,5
0,38
19,5
44,8
35,0
14,5
0,35
12,3
24,6
19,2
15,5
0,33
6,3
18,4
14,4
16,5
0,31
4,4
8,8
6,9
17,5
0,28
2,0
A royalty rate of 15% is estimated based on the max. revenue of USD 210 m, according to the figure in appendix XX
21,7
16,6
2,5
0,84
13,9
49,9
38,9
3,5
0,78
30,2
66,8
52,1
4,5
0,72
37,7
83,9
65,5
5,5
0,67
44,1
95,9
74,8
6,5
0,63
46,9
102,5
80,0
7,5
0,58
46,6
106,3
82,9
8,5
0,54
45,0
110,1
85,9
9,5
0,50
43,4
114,2
89,1
10,5
0,47
41,8
116,0
90,5
11,5
0,44
39,5
90,8
70,8
12,5
0,41
28,8
96
DCF Model for the Japanese Market (Tacro)
DCF Model for the Japanese Market
Probabilities
Likelyhood of finding a partner
Approval rate
Likelyhood of refusion
Cummulative
33%
90%
75%
22%
Inputs
Tax rate
WACC
Market share
Margin
Risk free rate
Exchange rate
Inflation
2013
25%
7,46%
10%
50%
1%
5,632
2%
NDA costs
2013
2014
25%
2015
24%
2014
2016+
22%
0
1
2,13%
0
0,5
0,993
0,0
40,5
42,2
1
2,13%
41,362568
1,5
0,979
40,5
2015
Launch
0
1
2,13%
0
2,5
0,966
0,0
Patients on tacrolimus
Penetration index
Patients on LCP-Tacro
Yearly price per patient (DKK)
Revenue (DKK m)
Max Revenue (DKK m)
Max Revenue (USD m)
2015
42.650
10%
426
34.643
14,8
202,0
35,9
2016
43.716
31%
1.355
35.380
47,9
2017
44.809
62%
2.778
36.133
100,4
2018
45.481
73%
3.320
36.903
122,5
2019
46.163
90%
4.155
37.688
156,6
2020
46.856
100%
4.686
38.490
180,3
2021
47.559
100%
4.756
39.310
187,0
2022
48.272
100%
4.827
40.146
193,8
2023
48.996
100%
4.900
41.001
200,9
2024
49.731
97%
4.824
41.874
202,0
2025
50.477
74%
3.735
42.765
159,7
2026
51.234
52%
2.664
43.675
116,4
2027
52.003
34%
1.768
44.605
78,9
2028
52.783
18%
950
45.554
43,3
2029
53.575
11%
589
46.524
27,4
2030
54.378
6%
326
47.514
15,5
2031
55.194
5%
276
48.526
13,4
Royalties
12,5%
6,0
4,7
3,5
0,78
3,6
12,5
9,8
4,5
0,72
7,1
15,3
11,9
5,5
0,67
8,0
19,6
15,3
6,5
0,63
9,6
22,5
17,6
7,5
0,58
10,3
23,4
18,2
8,5
0,54
9,9
24,2
18,9
9,5
0,50
9,5
25,1
19,6
10,5
0,47
9,2
25,2
19,7
11,5
0,44
8,6
20,0
15,6
12,5
0,41
6,3
14,5
11,3
13,5
0,38
4,3
9,9
7,7
14,5
0,35
2,7
5,4
4,2
15,5
0,33
1,4
3,4
2,7
16,5
0,31
0,8
1,9
1,5
17,5
0,28
0,4
1,7
1,3
18,5
0,26
0,3
NDA
Filing and launch associated costs
Inflation factor
Inflation
Inflation adjusted costs
Time factor
Discount factor
PV of CF's
PV of filing and launch associated costs
DCF (JAP)
Royalties for Veloxis (DKK m)
Royalties after tax (DKK m)
Time factor
Discount factor
PV of CF's (DKK m)
Static NPV of CF's (DKK m)
1,8
1,4
2,5
0,84
1,2
93,3
Risk-adjusted NPV (DKK m)
-19,5
97
Appendix 21: Risk Adjusted Deferred Tax Asset
Risk Adjusted Deferred Tax Asset
Cummulative Probability
Deferred Tax Asset
Risk Adjusted Defered Tax Asset
68%
401,4
272,9
98
Appendix 22: Estimation of no. of Patients on Tacro in the 3 Markets
Patients on LCP-Tacro in US
Patients living with transplanted kidney (2011)
CAGR (Pool of patients)
Tacrolimus share (estimation)
LCP-Tacro market share
SANITY CHECK
Prograf market share
Generics market share
Inflation
Patients on immunosuppression
Patients on tacrolimus
Patients on Prograf
Patients on generics
Yearly price Prograf
Yearly price generics
Coresponding market value (DKK b)
Penetration index
Patients on LCP-Tacro
174.414
1,50% skal justeres og armmenteres
85% skal argumenteres for
12,5%
2011
41%
59%
2,13%
2012
31%
69%
2011
174.414
148.252
60.783
87.469
48.881
28.383
5,454
2012
177.030
150.476
46.647
103.828
49.922
28.987
5,338
patent expiry
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
179.686 182.381 185.117 187.893 190.712 193.572 196.476 199.423 202.415 205.451 208.533 211.661 214.835 218.058 221.329 224.649 228.019 231.439 234.910
152.733 155.024 157.349 159.709 162.105 164.537 167.005 169.510 172.052 174.633 177.253 179.911 182.610 185.349 188.130 190.951 193.816 196.723 199.674
50.984
29.604
11%
2.164
24%
4.791
38%
7.700
56%
11.518
74%
15.448
88%
18.646
97%
20.861
100%
21.829
100%
22.157
100%
22.489
91%
20.772
62%
14.365
41%
9.642
25%
5.967
16%
3.876
12%
2.951
6%
1.498
99
Patients on LCP-Tacro in Europe
Patients living with transplanted kidney (2011)
CAGR (Pool of patients) (2011-2017)
CAGR (Pool of patients) (2018-2031)
Tacrolimus share (estimation)
LCP-Tacro market share
Exchange rate DKK/EUR as of July 1st 2011
187.402
2,5%
2,0%
52%
12,5%
7,4589
(Based on statement from direktøren)
Own conservative estimate
(Calculated as; patients on tacrolimus/total pool of patients)
(Euroinvestor.dk)
Data from Astellas A.R. 2012 p95
2011
Prograf+Advagraf sales Europe (DKK b)
Generics share on average
Generic sales Europe (b DKK)
Estimated total tacrolimus sales (DKK b)
4,117
3%
0,068
4,185
(4,117*3%*generic price discount)
Assumption
The overall tacrolimus share of the European immunosuppression market remains constat at 52%
2011
Estimated number of patients on tacrolimus
98.175 (Prograf+Astellas sales*0,26/Astellas price est +Prograf+Astellas sales*0,74/Prograf price est + Generic sales/Generic price est)
Patent expiry
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
Patients on immunosuppression
187.402 192.087 196.889 201.811 206.857 212.028 217.329 221.675 226.109 230.631 235.244 239.949 244.748 249.643 254.635 259.728 264.923 270.221 275.626 281.138
Patients on tacrolimus
98.175 100.630 103.145 105.724 108.367 111.076 113.853 116.130 117.872 119.640 121.435 123.256 125.105 126.982 128.886 130.820 132.782 134.774 136.795 138.847
Penetration index
8%
26%
57%
73%
88%
97%
100%
100%
100%
100%
98%
74%
52%
34%
18%
13%
6%
Patients on LCP-Tacro
1.057
3.522
7.914 10.389 12.774 14.292 14.955 15.179 15.407 15.638 15.555 11.922 8.503
5.643
3.032
2.223
1.041
Patients on LCP-Tacro in Japan
Patients living with transplanted kidney R.O.W. (2011) 124.787
CAGR (Pool of patients) (2011-2017)
2,5% (Based on statement from direktøren)
CAGR (Pool of patients) (2018-2031)
1,5% Own conservative estimate
LCP-Tacro market share
10%
Exchange rate DKK/JPY as of July 1st 2011
0,06366 (Euroinvestor.dk)
Total prograf+astagraf sale (2011) (DKK b)
Estimated number of patients on tacrolimus
Patients on tacrolimus
Penetration index
Patients on LCP-Tacro
1,513 (=60% (Astellas A.R. 2012 p95))
2011
38.639
2011
38.639
2012
39.605
2013
40.595
2014
41.610
2015
42.650
10%
426
2016
43.716
31%
1.355
2017
44.809
62%
2.778
2018
45.481
73%
3.320
2019
46.163
90%
4.155
2020
46.856
100%
4.686
2021
47.559
100%
4.756
2022
48.272
100%
4.827
Patent expiry
2023
2024
2025
48.996 49.731 50.477
100%
97%
74%
4.900
4.824
3.735
2026
51.234
52%
2.664
2027
52.003
34%
1.768
2028
52.783
18%
950
2029
53.575
11%
589
2030
54.378
6%
326
2031
55.194
5%
276
100
Appendix 23: Estimation of Inflation
Comsumer Price Index, Avg. Annual Inflation (DK) from 1992-2012
4,00%
3,50%
3,00%
2,50%
2,00%
1,50%
1,00%
0,50%
12
11
20
10
20
09
20
08
20
07
20
06
20
05
20
04
20
03
20
02
20
01
20
00
Avg. annual price increase (DK)
20
99
20
98
19
97
19
96
19
95
19
94
19
93
19
19
19
92
0,00%
Avg. annual price increase 1992-2012 (DK)
Source: dst.dk (=Denmark's statistics)
Data Year
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
Avg.
Avg. annual price
increase (DK)
2,1%
1,3%
2,0%
2,1%
2,1%
2,2%
1,8%
2,5%
2,9%
2,4%
2,4%
2,1%
1,2%
1,8%
1,9%
1,7%
3,4%
1,3%
2,3%
2,8%
2,4%
Avg. annual price
increase 19922012 (DK)
2,1286%
Source: dst.dk (Denmark's statistics
101
Appendix 24: Pool of Patients with Kidney Transplant (2011) & US Tacrolimus
Overall Living Kidney Transplant Population and de novo Transplants (2011)
US
EU
R.O.W.
Population
174.414
187.402
124.787
de novo
16.879
18.209
17.979
Maintenance Therapy in the US (2008)
Cyclosporine
Tacrolimus
Sirolimus
7,6%
87,8%
4,1%
Immunosuppressive Medication Sales W.W.
Total Sales
2005
USD 5.3b
2010
USD 5.8b
Source: isotechnika.com/dnn/ProductsInDevelopment/Voclosporin/ImmunosuppressionMarket.aspx
102