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Transcription:

Austar Lifesciences Limited 6118 2019 12 31 2019 2018 1,049,021 816,585 284,244 204,394 12,208 3,498 8,091 107 1,174,322 1,071,370 502,625 482,923 27.1% 25.0% 1.5 1.5 10.2% 5.4% 0.02 0.00 0.02 0.00 2019 2018 12 31 2019 2018 12 31 1

2019 12 31 2018 12 31 2019 2018 12 31 12 31 3 1,049,021 816,585 6 (764,777) (612,191) 284,244 204,394 6 (137,077) (105,635) 6 (108,731) (77,450) (5,109) (4,066) 6 (42,577) (30,308) 9,153 3,148 5 146 (1,667) 49 (11,584) 4 5,703 5,073 4 (3,736) (1,653) 1,967 3,420 10,192 11,662 12,208 3,498 8 (4,744) (3,378) 7,464 120 8,091 107 (627) 13 2

2019 2018 12 31 12 31 7,464 120 5,713 8,774 55 (129) (213) (277) 5,555 8,368 13,019 8,488 13,573 8,475 (554) 13 13,019 8,488 9 0.02 0.00 3

2019 2018 12 31 12 31 55,005 50,569 90,426 54,212 26,253 9,012 6,558 7,264 57,509 47,728 10,399 9,724 246,150 178,509 163,517 131,885 12 185,747 126,235 11 251,091 286,133 47,746 55,127 88,778 96,816 209 206 191,084 196,459 928,172 892,861 1,174,322 1,071,370 4,071 4,071 389,560 384,078 100,906 92,815 494,537 480,964 8,088 1,959 502,625 482,923 4

2019 2018 12 31 12 31 24,988 1,972 3,511 10,950 8,009 37,910 11,520 13 378,708 356,077 12 222,276 193,977 907 985 11,896 14 20,000 25,888 633,787 576,927 671,697 588,447 1,174,322 1,071,370 5

2019 12 31 1. 2014 1 9 22 1961 3 Cricket Square, Hutchins Drive, P.O. Box 2681, Grand Cayman KY1-1111, Cayman Islands Standard Fortune Holdings Limited 0.01 2014 11 7 2020 3 27 2. 2.1 622 6

(a) 2019 1 1 16 16 2019 1 1 (b) 2019 12 31 2.2 16 2019 1 1 16 2018 2019 1 1 16 17 2019 1 1 2019 1 1 4.73 7

(a) 16 2019 1 1 2019 1 112 17 4 (b) 2019 2018 12 31 16,105 14,571 21,111 2019 1 1 35,682 13,322 22,360 35,682 8

(c) 2018 12 31 (d) 2019 1 1 2019 1 1 91,911,000 2,017,000 35,682,000 54,212,000 (e) 16 3. (1) (2) (3) (4) GMP (5)(6) 9

2019 12 31 GMP 482,816 300,934 87,175 54,685 204,303 24,056 1,153,969 (46,836) (50,059) (4,212) (1,044) (717) (2,080) (104,948) 435,980 250,875 82,963 53,641 203,586 21,976 1,049,021 82,829 55,871 31,572 8,468 203,586 21,976 404,302 353,151 195,004 51,391 45,173 644,719 (361,347) (191,980) (55,048) (25,525) (116,941) (13,936) (764,777) 74,633 58,895 27,915 28,116 86,645 8,040 284,244 1,536 632 58 33 15 2,274 13,434 6,338 1,119 698 2,141 293 24,023 4,872 (263) (191) (79) 819 (49) 5,109 11,902 1,018 165 104 344 43 13,576 5,222 (208) 5,178 10,192 10

2018 12 31 GMP 350,953 207,397 93,001 38,968 191,309 21,534 903,162 (30,112) (42,685) (1,649) (2,088) (4,135) (5,908) (86,577) 320,841 164,712 91,352 36,880 187,174 15,626 816,585 67,157 31,609 26,005 2,283 187,174 15,626 329,854 253,684 133,103 65,347 34,597 486,731 (280,270) (128,989) (61,794) (17,948) (113,192) (9,998) (612,191) 40,571 35,723 29,558 18,932 73,982 5,628 204,394 1,142 728 90 36 14 13 2,023 4,559 1,692 548 219 475 80 7,573 1,146 1,275 880 353 347 65 4,066 5,328 293 140 58 1,026 23 6,868 3,418 4,180 4,064 11,662 11

2019 2018 12 31 12 31 74,633 40,571 58,895 35,723 27,915 29,558 GMP 28,116 18,932 86,645 73,982 8,040 5,628 284,244 204,394 (137,077) (105,635) (108,731) (77,450) (5,109) (4,066) (42,577) (30,308) 9,153 3,148 146 (1,667) 1,967 3,420 10,192 11,662 12,208 3,498 12

2019 2018 12 31 2019 12 31 2018 12 31 354,973 17,369 306,283 12,164 255,540 21,517 185,321 21,923 70,490 65,426 GMP 32,586 24,256 136,658 18,623 87,610 13,641 28,085 11,673 878,332 57,509 680,569 47,728 6,558 7,264 289,432 383,537 1,174,322 1,071,370 13

2019 2018 12 31 12 31 964,135 766,057 84,886 50,528 1,049,021 816,585 2019 2018 12 31 12 31 152,502 113,669 76,691 47,852 229,193 161,521 14

4. 2019 2018 12 31 12 31 (1,739) (1,445) (1,610) (387) (208) (3,736) (1,653) 5,194 4,582 PALL-AUSTAR Lifesciences Limited PALL-AUSTAR JV 509 491 5,703 5,073 1,967 3,420 5. 2019 2018 12 31 12 31 (218) (175) (2,415) (1,328) 2,779 (164) 146 (1,667) 15

6. 2019 2018 12 31 12 31 570,889 485,646 225,741 162,787 59,659 24,671 43,136 38,211 22,176 16,453 21,973 14,012 13,576 6,868 13,310 8,281 11,176 7,573 12,847 935 Austar Limited 91 8,913 10,524 11,032 6,548 4,279 4,988 3,553 4,338 3,194 9 1,270 2,274 2,023 1,997 1,773 28,001 24,019 1,053,162 825,584 7. 2019 2018 12 31 12 31 177,499 126,857 48,242 35,930 225,741 162,787 16

8. 2019 2018 12 31 12 31 2,903 3,036 1,841 342 4,744 3,378 16.5% 2018 16.5% 30% 2018 30% 25% 15% 2014 2018 20132019 2019 12 31 20% 50% 17

9. (a) 2019 2018 12 31 12 31 8,091 107 512,582 512,582 0.02 0.00 (b) 2019 2018 12 31 2019 2018 12 31 10. 2019 12 31 2018 18

11. 2019 2018 12 31 12 31 (b) 226,963 227,222 (a) 47,116 80,115 274,079 307,337 (22,988) (21,204) 251,091 286,133 (a) 2018 (b) 2019 2018 12 31 12 31 6 143,827 141,334 6 1 17,536 20,817 1 2 29,576 43,624 2 3 26,767 8,581 3 9,257 12,866 226,963 227,222 90 19

12. 2019 2018 12 31 12 31 186,523 128,547 (3,659) (5,674) 182,864 122,873 2,883 3,362 185,747 126,235 (222,276) (193,977) 13. 2019 2018 12 31 12 31 236,504 215,007 25,244 25,934 37,856 37,622 3,510 12,845 12,422 6,250 29,883 18,923 5,533 7,552 1,563 26,193 31,944 378,708 356,077 20

2019 2018 12 31 12 31 6 206,632 194,042 6 1 14,597 9,231 1 2 7,550 5,127 2 3 2,735 2,143 3 4,990 4,464 236,504 215,007 14. 2019 2018 12 31 12 31 20,000 20,000 5,888 20,000 25,888 2019 12 31 2019 12 31 4.57% 2018 4.35% 4.79% 21

2019 2019 12 1 (MAH) (CDMOs) ( ) GMP 2019 12 EMA GMP GMP 2019 GMP FDA Zanubrutinib 2019 FDA 22

BPC 2019 API 5 8 CDMO CDMO CDMO 2018 28.6% 28.5% 2018 2019 39.1% 3 4 23

2018 1. 2. 3. 24

12 31 2019 2018 % % % 607,398 42.3% 434,097 38.9% 39.9% 330,727 23.0% 268,124 24.0% 23.3% 118,418 8.3% 125,529 11.2% (5.7%) GMP 89,284 6.2% 46,602 4.2% 91.6% 267,527 18.6% 215,740 19.3% 24.0% 22,512 1.6% 26,371 2.4% (14.6%) 1,435,866 100.0% 1,116,463 100.0% 28.6% 1,435.9 2018 12 31 1,116.5 28.6% GMP 25

607.4 2018 12 31 434.1 173.3 39.9% H+E GmbH H+E Pharma GmbH H+E Pharma 2018 12 31 268.1 62.6 23.3% 330.7 IT 2015 2018 12 31 125.5 7.1 5.7% 118.4 26

GMP GMP GMP 2018 12 31 46.6 42.7 91.6% 89.3 GMP 2018 12 31 215.7 51.8 24.0% 267.5 PALL-AUSTAR JV 2018 12 31 26.4 3.9 14.6% 22.5 27

2019 12 31 2019 12 31 % % 305 32.3% 404,485 45.8% 257 27.2% 261,648 29.6% 108 11.4% 92,644 10.5% GMP 107 11.3% 80,621 9.2% 168 17.8% 43,539 4.9% 945 100.0% 882,937 100.0% MES 2019 2019 2020 OEE 2019 H+E Pharma H+E Pharma S-Tec GmbH S-TecS-Tec 28

2020 4 2018 2019 15.3% PALL-AUSTAR JV 2020 ROTA Verpackungstechnik GmbH & Co. KG ROTA Verpackungstechnik Verwaltungsgesellschaft mbhrota 2020 ROTA 2019 STERIS H+E Pharma 29

2018 12 2019 2020 2019 PEC 20 424 2019 PEC 771 454 2019 CPhI&P-MEC CIPM Medtec HVAC 2019 30

2019 EHS 4.0 Car-T 2019 180 25 5 2019 12 31 228 32 3 49 Mindsphere Pharma LeanTec Pharma LeanDigital MES + BATCH 31

AusMill 2020 30 2020 PAT OSD OSD PAT University of Erlangen-Nuremberg WFI GPC 32

2019 HVAC STERIS STERIS STERIS H+E GmbH H+E Pharma 2019 2020 2020 2019 33

2018 2019 OSD 34

12 HVAC EMS BMS 2018 2 3 12 SME TAC 1. 2. 3. 35

1. 50% 2. 3. 5 8 1. 2. 3 5 8 3. 1. 2. OSD 3. HVAC VHP EMS BMS 36

2020 4 2*2000L 1*2000L 1*500L 82 53 37

H+E GmbH H+E Pharma 2019 H+E H+E Pharma 2019 ROTA 2020 ROTA 3 2019 3 2020 2019 Mindsphere 10 Mindsphere 38

Werum IT Solutions Werum MES Werum REMOIS HVAC VHP BMS EMS (a) GMP (b) BMS/EMS/MES (c) VHP (d) GMP HVAC (e) BIM 39

(f) AusMill TAC AusMill 2019 40

GMP GMP GxP GCP GEP ICH Q10 Quality by Design ASTM E2500 CQVGMP CQVQMS PD-1 CAR-T CDMO PQS ICH Q10 CDMO OEL OEBPDE 3 41

2020 VHP (1) (2) (3) (4)GMP (5) (6) 42

1,049.0 201828.5% GMP 2019 2018 12 31 12 31 2019 2018 % % % 435,980 41.6% 320,841 39.3% 35.9% 250,875 23.9% 164,712 20.2% 52.3% 82,963 7.9% 91,352 11.2% (9.2%) GMP 53,641 5.1% 36,880 4.5% 45.4% 203,586 19.4% 187,174 22.9% 8.8% 21,976 2.1% 15,626 1.9% 40.6% 1,049,021 100.0% 816,585 100.0% 28.5% 2018 12 31 320.8 115.2 35.9% 436.0 2018 12 31 43

2018 12 31 164.7 86.2 52.3% 250.9 2018 12 31 2018 12 31 91.48.49.2% 83.0 2019 GMP GMP 2018 12 31 36.9 16.7 45.4% 53.6 GMP 2018 12 31 187.2 16.48.8% 203.6 44

2018 12 31 15.6 6.4 40.6% 22.0 2018 12 31 2019 2018 12 31 12 31 2019 2018 % % % 964,135 91.9% 766,057 93.8% 25.9% 84,886 8.1% 50,528 6.2% 68.0% 1,049,021 100.0% 816,585 100.0% 28.5% 91.9% 2018 93.8% 2018 12 31 612.2 152.6 24.9% 764.8 2018 12 31 204.4 79.8 39.1% 284.2 2018 12 31 25.0% 27.1% 45

12 31 2019 2018 % % % % 74,633 26.3% 17.1% 40,571 19.8% 12.6% 58,895 20.7% 23.5% 35,723 17.5% 21.7% 27,915 9.8% 33.6% 29,558 14.5% 32.4% GMP 28,116 9.9% 52.4% 18,932 9.3% 51.3% 86,645 30.5% 42.6% 73,982 36.2% 39.5% 8,040 2.8% 36.6% 5,628 2.7% 36.0% 284,244 100.0% 27.1% 204,394 100.0% 25.0% 1. 2. 46

2018 12 31 40.6 34.0 83.7% 74.6 2018 12 31 12.6% 17.1% 2018 12 31 35.7 23.2 65.0% 58.9 2018 12 31 21.7% 23.5% LEAN 2018 12 31 29.61.75.7% 27.9 2018 12 31 32.4% 33.6% 47

GMP GMP 2018 12 31 18.9 9.248.7% 28.1 2018 12 31 51.3% GMP 52.4% 2018 12 31 74.0 12.6 17.0% 86.6 2018 12 31 39.5% 42.6% 2018 12 31 5.6 2.4 42.9% 8.0 2018 12 31 36.0% 36.6% 2018 12 31 3.1 6.1 196.8% 9.2 48

0.1 2018 12 31 1.7 2018 12 31 105.6 31.5 29.8% 137.1 2018 12 31 77.5 31.240.3% 108.7 2019 12 31 433.3% 2018 12 31 30.3 12.3 40.6% 42.6 49

2018 12 31 3.4 2.0 / 1.6 0.3 0.6 2018 12 31 11.7 1.5 10.2 2020 4.4 2020 PALL-AUSTAR JV STERIS-AUSTAR JV 1.1 1.8 2018 12 31 3.5 12.2 2018 12 31 3.4 1.3 4.7 1.5 2018 12 31 0.1 7.5 50

12 31 2019 2018 37,793 (77,598) (22,087) (39,495) (20,694) 4,440 (4,988) (112,653) 37.8 i. 12.2 24.0 2.3 ii. 35.0 7.4 iii. 28.3 22.6 iv. 31.6 59.5 22.1 i. H+E Pharma 11.5 ii. 13.7 51

20.7 30.9 10.1 3.3 1.4 25.0 2019 12 31 2018 12 31 191.1 196.5 88.8 96.8 2019 12 31 2018 12 31 315.9 21.5 2019 12 31 294.4 2019 12 31 928.2 2018 12 31 892.9 35.3 i. 31.6 59.5 ii. 35.0 7.4 8.0 5.4 2019 12 31 633.8 2018 12 31 576.9 56.9 28.3 22.6 11.9 5.9 52

2019 12 31 20.0 5.9 4.57% 2018 4.35% 4.79% 2019 12 31 10.2% 2018 12 31 5.4% 100% 2019 12 31 88.8 6.4 5.42018 12 31 7.1 5.5 20.02018 12 31 20.0 2019 12 31 2018 12 31 2019 12 31 1,312 2018 12 31 174 225.7 2018 12 31 162.8 38.6% 53

2019 12 31 2.2 54

2014 1 9 2014 11 7 IPO IPO 411.8 2014 10 28 2019 12 31 2019 12 31 2019 12 31 39.6% 163.1 126.7 55.7 32.6 107.4 94.1 1 14.2% 58.4 45.4 58.4 45.4 2 6.8% 28.0 21.8 28.0 21.8 9.5% 39.1 30.4 39.1 30.4 20% 82.4 64.0 43.9 29.6 38.5 34.4 9.9% 40.8 31.7 40.8 31.7 100.0% 411.8 320.0 207.5 146.1 204.3 173.9 55

1. 126.7 163.1 2018 9 18 94.1 107.4 2. 45.4 58.4 2019 12 31 45.4 58.4 226.6 2019 12 31 204.3 56

2020 2019 COVID-19 2020 3 2020 3 COVID-19 COVID-19 2018 2020 5 29 2020 2020 5 26 2020 5 29 2020 2020 5 25 183 54 57

A.2.1 A.2.1 58

2014 10 21 2019 12 31 2019 12 31 59

(www.hkexnews.hk) (www.austar.com.hk) 2020 3 27 60