国盛证券-美诺华（603538）紧抓时代机遇华丽转身，制剂一体化+cmo …
TRANSCRIPT
-603538+CMO-200602.pdf
30 20
CMO
2
2020-2022 15.28 19.91 26.19
29.4%30.4%31.5% 1.99 2.69
3.67 31.5%35.4%36.4% PE
37x27x20x“”
849 1,180 1,528 1,991 2,619
yoy% 40.2 39.0 29.4 30.4 31.5
96 151 199 269 367
yoy%
EPS/ 0.64 1.01 1.33 1.80 2.45
% 7.8 10.3 12.2 14.3 16.4
P/E 75.2 48.0 36.5 27.0 19.8
P/B 6.1 5.3 4.7 4.0 3.4
P.2
2018A 2019A 2020E 2021E 2022E 2018A 2019A 2020E 2021E 2022E
1073 1136 1327 1640 2104 849 1180 1528 1991 2619
370 342 345 450 592 572 728 927 1181 1520
158 176 256 307 434 10 11 19 24 29
16 16 26 29 43 19 21 29 36 56
10 9 16 16 26 109 163 204 273 367
299 400 490 645 816 39 53 72 106 157
220 193 193 193 193 11 20 22 29 38
1198 1478 1667 1927 2286 8 -12 0 0 0
114 134 151 167 184 6 12 0 0 0
457 658 818 1019 1288 0 -1 0 0 0
175 183 203 225 242 28 7 -3 -4 -3
452 502 495 516 572 -2 0 0 0 0
2271 2614 2994 3567 4390 113 190 252 339 448
779 876 1076 1391 1853 1 7 6 4 5
428 429 504 726 964 7 9 6 6 7
262 309 419 509 685 107 187 252 337 445
89 138 154 156 203 2 26 36 44 48
151 169 150 133 121 105 161 216 293 397
108 123 104 88 75 9 10 17 24 31
44 46 46 46 46 96 151 199 269 367
931 1045 1226 1524 1973 EBITDA 180 276 352 469 617
143 204 222 246 277 EPS/ 0.64 1.01 1.33 1.80 2.45
149 150 150 150 150
520 552 552 552 552
565 686 853 1063 1369 2018A 2019A 2020E 2021E 2022E
1197 1364 1546 1797 2140
2271 2614 2994 3567 4390 % 40.2 39.0 29.4 30.4 31.5
% 76.2 68.6 33.0 34.4 32.0
% 115.7 56.6 31.5 35.4 36.4
% 11.3 12.8 13.0 13.5 14.0
2018A 2019A 2020E 2021E 2022E ROE% 7.8 10.3 12.2 14.3 16.4
47 180 275 310 470 ROIC% 7.2 9.1 10.6 11.9 13.3
105 161 216 293 397
51 65 79 103 133 % 41.0 40.0 41.0 42.7 44.9
11 20 22 29 38 % 14.2 17.7 17.7 20.3 20.8
-28 -7 3 4 3 1.4 1.3 1.2 1.2 1.1
-106 -93 -45 -119 -102 0.7 0.7 0.7 0.6 0.6
14 34 0 0 0
-326 -351 -272 -367 -497 0.4 0.5 0.5 0.6 0.7
300 328 173 243 343 7.3 7.1 7.1 7.1 7.1
15 -52 -17 -18 -17 2.7 2.5 2.5 2.5 2.5
-11 -75 -116 -142 -170
384 99 -74 -61 -70 0.64 1.01 1.33 1.80 2.45
273 1 0 0 0 0.31 1.20 1.84 2.07 3.14
108 16 -19 -17 -13 8.00 9.11 10.33 12.00 14.30
29 1 0 0 0
13 32 0 0 0 P/E 75.2 48.0 36.5 27.0 19.8
-39 50 -55 -45 -57 P/B 6.1 5.3 4.7 4.0 3.4
103 -70 -71 -118 -96 EV/EBITDA 42.2 27.7 21.8 16.6 12.8
P.3
..............................................................................................................7
3.1.1 300 ............................................................ 15
3.1.2 ........................................... 18
3.1.3 200 ............................................................... 20
3.2 ......................................................................................... 21
3.3.1 .................................................................. 23
............................................................................................................................................. 27
6...................................................................................................................................9
15 DMF ................................................................................................................ 13
16 API ........................................................................................................... 13
17 ............................................................................................................................... 14
18 .................................................................................................................................. 15
222015 ........................................................................... 18
23............................................................................................................................ 18
262015 ............................................................................... 19
2020 06 02
P.4
30............................................................................................................................ 20
33............................................................................................................................ 21
44KRKA 2018 .......................................................................................................... 27
45 KRKA ......................................................................................................................... 27
47 ......................................................................................................................................... 28
P.5
NDMA
LCMS 1ppm
GMP FDA GMP PMDA
P.6
2017 12 KRKA
KRKA KRKA 1954
2014 KRKA 16 KRKA 2018
13.32 103 1.74 13
KRKA
5% 150
P.7
FDA GMP PMDA
2
KRKA 26.66%
29.76%
P.8
2018
1
3 5 23 4
12.5%2019
GMP
2019 70%
yoy yoy
2020 06 02
P.9
7
-
-
-
P.10
-5%
0%
5%
10%
15%
20%
/
P.11
2013.9.10
2015.4.16
2015.12.31
2016.11.7
2020 06 02
P.12
2017 11 30 CFDA
2017 146
2016 3 5 CFDA
3
2018 12 6 “4+7” 2019
4 +7 2019
P.13
API
API
clarivate
P.14
21
1
3 In house (ICH) EDMF plan
4
5 EP, USP EDMF, CEP
6 EP, USP EDMF
7 EP, USP EDMF
8 EP EDMF
12 EP, USP EDMF
9 In house (ICH) EDMF
10
11 EP, USP EDMF, CEP 2018
13
14 EP, USP EDMF, CEP
15 EP, USP EDMF plan
16 In house (ICH) EDMF plan
18 EP, USP EDMF
19 In house (ICH) EDMF
20
21 EP EDMF
24
25 In house (ICH) EDMF plan
26 In house (ICH) EDMF plan
28
29 In house (ICH) EDMF plan
30 In house (ICH) EDMF plan
23 In house (ICH) EDMF plan
27 In house (ICH) EDMF plan
31 In house (ICH) EDMF plan
32 In house (ICH) EDMF plan
33 In house (ICH) EDMF plan
34 In house (ICH) EDMF to be prepared
2020 06 02
P.15
36
37 In house (ICH) EDMF to be prepared
38
35 In house (ICH) EDMF to be prepared
39 In house (ICH) EDMF to be prepared
WHO 2012
25 1/310
2000
QYResearch 2002
191 2010 300 2016 323
1.2% 2022
350
70 β-
CCB80 ACEI
90 ARB
18
CCB
P.16
800 300 100
60 2015 3300
——NDMA
0
200
400
600
800
1000
1200
1400
2012 2013 2014 2015
P.17
21
2019 15%
30% 40% 80%
2013-04 2013-12 2014-08 2015-04 2015-12 2016-08 2017-04 2017-12 2018-08 2019-04 2019-12
: :
2020 06 02
P.18
Lipitor 1996 FDA 1644
201617.58
Crestor
LDL“”
2018 14.33
23 24
447.29 12.20%
201596.55 9.26%
P.19
7%
2015
KRKA
P.20
wind
200
IMS
2015 200 7.65%TOP 20
184.65 7.83% 10
/
Plavix 10
2012 5
45.9% 20
30
: :
-70%
-60%
-50%
-40%
-30%
-20%
-10%
0%
10%
20%
30%
40%
0
20
40
60
80
100
120
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
yoy
P.21
34
3.2
0%
1%
2%
3%
4%
5%
6%
7%
0
100
200
300
400
500
600
700
yoy
P.22
35
2520
1600
40
13
160
60
78
20
40
60
30
2
8
60
10
20
30
10
10
P.23
100
50
50
10
100%
100% GSK
GMP
37
CDMO 100%
GMP
KRKA
2017
GMP 2018 9 GMP
P.24
2 H13022398
3 H13022397
4 H13024151
5 H13022376
6 H13022372
7 H13023798
8 H13022374
9 H13022375
10 H13024520
11 H13022377
12 H13023800
13 H13023478
14 H13023479
15 H13023801
16 H13024152
17 H13022373
18 H13024150
19 H13023797
P.25
≥12
P.26
KRKA 1954
27%
2014 KRKA 16 KRKA
2019 14.93 116 12%
2.42 19 39%
KRKA 5%2019
150
42KRKA 43KRKA
KRKA
KRKA
yoy
yoy
P.27
KRKA
KRKA CMO
KRKA 100%
40%
2019 9
4.
P.28
yoy 0.79% 43.31% 33.27% 20.00% 20.00% 20.00%
38.43% 36.69% 36.42% 44.22% 41.90% 41.90% 41.90%
yoy 678% 116% 81% 60%
-63.79% 7.48% 40.00% 43.00% 45.00%
CMO
0.08 0.04 0.14 0.03 0.03 0.03 0.03
yoy -89.33% -50.00% 250.00% -78.57% 0% 0% 0%
25.00% 825.00% 14.29% 33.33% 33.33% 33.33% 33.33%
5.78 6.05 8.49 11.80 15.28 19.91 26.19
yoy -3.34% 4.67% 40.33% 38.96% 29.44% 30.36% 31.52%
37.28% 34.07% 32.63% 38.32% 39.33% 40.68% 41.96%
0.79 0.45 0.96 1.51 1.99 2.69 3.67
yoy 2.37% -43.33% 115.66% 57.29% 31.52% 35.37% 36.39%
+CMO
30-35x 2021
90-100 2020-2022 15.28 19.91 26.19
29.4%30.4%31.5% 1.99 2.69
3.67 31.5%35.4%36.4% PE 37x27x
20x“”
47
TTM)
%
%
%
% %
45 1.81 18.29 1.66 4.49 38.35 wind
2020 06 02
P.29
P.30
,
“”
500
-5%~+5%
5%
100032
010-57671718
[email protected]
200120
021-38934111
[email protected]
518033
[email protected]
30 20
CMO
2
2020-2022 15.28 19.91 26.19
29.4%30.4%31.5% 1.99 2.69
3.67 31.5%35.4%36.4% PE
37x27x20x“”
849 1,180 1,528 1,991 2,619
yoy% 40.2 39.0 29.4 30.4 31.5
96 151 199 269 367
yoy%
EPS/ 0.64 1.01 1.33 1.80 2.45
% 7.8 10.3 12.2 14.3 16.4
P/E 75.2 48.0 36.5 27.0 19.8
P/B 6.1 5.3 4.7 4.0 3.4
P.2
2018A 2019A 2020E 2021E 2022E 2018A 2019A 2020E 2021E 2022E
1073 1136 1327 1640 2104 849 1180 1528 1991 2619
370 342 345 450 592 572 728 927 1181 1520
158 176 256 307 434 10 11 19 24 29
16 16 26 29 43 19 21 29 36 56
10 9 16 16 26 109 163 204 273 367
299 400 490 645 816 39 53 72 106 157
220 193 193 193 193 11 20 22 29 38
1198 1478 1667 1927 2286 8 -12 0 0 0
114 134 151 167 184 6 12 0 0 0
457 658 818 1019 1288 0 -1 0 0 0
175 183 203 225 242 28 7 -3 -4 -3
452 502 495 516 572 -2 0 0 0 0
2271 2614 2994 3567 4390 113 190 252 339 448
779 876 1076 1391 1853 1 7 6 4 5
428 429 504 726 964 7 9 6 6 7
262 309 419 509 685 107 187 252 337 445
89 138 154 156 203 2 26 36 44 48
151 169 150 133 121 105 161 216 293 397
108 123 104 88 75 9 10 17 24 31
44 46 46 46 46 96 151 199 269 367
931 1045 1226 1524 1973 EBITDA 180 276 352 469 617
143 204 222 246 277 EPS/ 0.64 1.01 1.33 1.80 2.45
149 150 150 150 150
520 552 552 552 552
565 686 853 1063 1369 2018A 2019A 2020E 2021E 2022E
1197 1364 1546 1797 2140
2271 2614 2994 3567 4390 % 40.2 39.0 29.4 30.4 31.5
% 76.2 68.6 33.0 34.4 32.0
% 115.7 56.6 31.5 35.4 36.4
% 11.3 12.8 13.0 13.5 14.0
2018A 2019A 2020E 2021E 2022E ROE% 7.8 10.3 12.2 14.3 16.4
47 180 275 310 470 ROIC% 7.2 9.1 10.6 11.9 13.3
105 161 216 293 397
51 65 79 103 133 % 41.0 40.0 41.0 42.7 44.9
11 20 22 29 38 % 14.2 17.7 17.7 20.3 20.8
-28 -7 3 4 3 1.4 1.3 1.2 1.2 1.1
-106 -93 -45 -119 -102 0.7 0.7 0.7 0.6 0.6
14 34 0 0 0
-326 -351 -272 -367 -497 0.4 0.5 0.5 0.6 0.7
300 328 173 243 343 7.3 7.1 7.1 7.1 7.1
15 -52 -17 -18 -17 2.7 2.5 2.5 2.5 2.5
-11 -75 -116 -142 -170
384 99 -74 -61 -70 0.64 1.01 1.33 1.80 2.45
273 1 0 0 0 0.31 1.20 1.84 2.07 3.14
108 16 -19 -17 -13 8.00 9.11 10.33 12.00 14.30
29 1 0 0 0
13 32 0 0 0 P/E 75.2 48.0 36.5 27.0 19.8
-39 50 -55 -45 -57 P/B 6.1 5.3 4.7 4.0 3.4
103 -70 -71 -118 -96 EV/EBITDA 42.2 27.7 21.8 16.6 12.8
P.3
..............................................................................................................7
3.1.1 300 ............................................................ 15
3.1.2 ........................................... 18
3.1.3 200 ............................................................... 20
3.2 ......................................................................................... 21
3.3.1 .................................................................. 23
............................................................................................................................................. 27
6...................................................................................................................................9
15 DMF ................................................................................................................ 13
16 API ........................................................................................................... 13
17 ............................................................................................................................... 14
18 .................................................................................................................................. 15
222015 ........................................................................... 18
23............................................................................................................................ 18
262015 ............................................................................... 19
2020 06 02
P.4
30............................................................................................................................ 20
33............................................................................................................................ 21
44KRKA 2018 .......................................................................................................... 27
45 KRKA ......................................................................................................................... 27
47 ......................................................................................................................................... 28
P.5
NDMA
LCMS 1ppm
GMP FDA GMP PMDA
P.6
2017 12 KRKA
KRKA KRKA 1954
2014 KRKA 16 KRKA 2018
13.32 103 1.74 13
KRKA
5% 150
P.7
FDA GMP PMDA
2
KRKA 26.66%
29.76%
P.8
2018
1
3 5 23 4
12.5%2019
GMP
2019 70%
yoy yoy
2020 06 02
P.9
7
-
-
-
P.10
-5%
0%
5%
10%
15%
20%
/
P.11
2013.9.10
2015.4.16
2015.12.31
2016.11.7
2020 06 02
P.12
2017 11 30 CFDA
2017 146
2016 3 5 CFDA
3
2018 12 6 “4+7” 2019
4 +7 2019
P.13
API
API
clarivate
P.14
21
1
3 In house (ICH) EDMF plan
4
5 EP, USP EDMF, CEP
6 EP, USP EDMF
7 EP, USP EDMF
8 EP EDMF
12 EP, USP EDMF
9 In house (ICH) EDMF
10
11 EP, USP EDMF, CEP 2018
13
14 EP, USP EDMF, CEP
15 EP, USP EDMF plan
16 In house (ICH) EDMF plan
18 EP, USP EDMF
19 In house (ICH) EDMF
20
21 EP EDMF
24
25 In house (ICH) EDMF plan
26 In house (ICH) EDMF plan
28
29 In house (ICH) EDMF plan
30 In house (ICH) EDMF plan
23 In house (ICH) EDMF plan
27 In house (ICH) EDMF plan
31 In house (ICH) EDMF plan
32 In house (ICH) EDMF plan
33 In house (ICH) EDMF plan
34 In house (ICH) EDMF to be prepared
2020 06 02
P.15
36
37 In house (ICH) EDMF to be prepared
38
35 In house (ICH) EDMF to be prepared
39 In house (ICH) EDMF to be prepared
WHO 2012
25 1/310
2000
QYResearch 2002
191 2010 300 2016 323
1.2% 2022
350
70 β-
CCB80 ACEI
90 ARB
18
CCB
P.16
800 300 100
60 2015 3300
——NDMA
0
200
400
600
800
1000
1200
1400
2012 2013 2014 2015
P.17
21
2019 15%
30% 40% 80%
2013-04 2013-12 2014-08 2015-04 2015-12 2016-08 2017-04 2017-12 2018-08 2019-04 2019-12
: :
2020 06 02
P.18
Lipitor 1996 FDA 1644
201617.58
Crestor
LDL“”
2018 14.33
23 24
447.29 12.20%
201596.55 9.26%
P.19
7%
2015
KRKA
P.20
wind
200
IMS
2015 200 7.65%TOP 20
184.65 7.83% 10
/
Plavix 10
2012 5
45.9% 20
30
: :
-70%
-60%
-50%
-40%
-30%
-20%
-10%
0%
10%
20%
30%
40%
0
20
40
60
80
100
120
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
yoy
P.21
34
3.2
0%
1%
2%
3%
4%
5%
6%
7%
0
100
200
300
400
500
600
700
yoy
P.22
35
2520
1600
40
13
160
60
78
20
40
60
30
2
8
60
10
20
30
10
10
P.23
100
50
50
10
100%
100% GSK
GMP
37
CDMO 100%
GMP
KRKA
2017
GMP 2018 9 GMP
P.24
2 H13022398
3 H13022397
4 H13024151
5 H13022376
6 H13022372
7 H13023798
8 H13022374
9 H13022375
10 H13024520
11 H13022377
12 H13023800
13 H13023478
14 H13023479
15 H13023801
16 H13024152
17 H13022373
18 H13024150
19 H13023797
P.25
≥12
P.26
KRKA 1954
27%
2014 KRKA 16 KRKA
2019 14.93 116 12%
2.42 19 39%
KRKA 5%2019
150
42KRKA 43KRKA
KRKA
KRKA
yoy
yoy
P.27
KRKA
KRKA CMO
KRKA 100%
40%
2019 9
4.
P.28
yoy 0.79% 43.31% 33.27% 20.00% 20.00% 20.00%
38.43% 36.69% 36.42% 44.22% 41.90% 41.90% 41.90%
yoy 678% 116% 81% 60%
-63.79% 7.48% 40.00% 43.00% 45.00%
CMO
0.08 0.04 0.14 0.03 0.03 0.03 0.03
yoy -89.33% -50.00% 250.00% -78.57% 0% 0% 0%
25.00% 825.00% 14.29% 33.33% 33.33% 33.33% 33.33%
5.78 6.05 8.49 11.80 15.28 19.91 26.19
yoy -3.34% 4.67% 40.33% 38.96% 29.44% 30.36% 31.52%
37.28% 34.07% 32.63% 38.32% 39.33% 40.68% 41.96%
0.79 0.45 0.96 1.51 1.99 2.69 3.67
yoy 2.37% -43.33% 115.66% 57.29% 31.52% 35.37% 36.39%
+CMO
30-35x 2021
90-100 2020-2022 15.28 19.91 26.19
29.4%30.4%31.5% 1.99 2.69
3.67 31.5%35.4%36.4% PE 37x27x
20x“”
47
TTM)
%
%
%
% %
45 1.81 18.29 1.66 4.49 38.35 wind
2020 06 02
P.29
P.30
,
“”
500
-5%~+5%
5%
100032
010-57671718
[email protected]
200120
021-38934111
[email protected]
518033
[email protected]