KYOWA KIRIN CO. LTD. January 29, 2016 |
Kyowa Hakko Kirin Co., Ltd. Appendix to the Consolidated Financial Summary Fiscal 2015 (January 1, 2015 - December 31, 2015) |
・This document was made as a supplement to the Kessan Tanshin (financial report), disclosed at the Tokyo Stock Exchange on January 29, 2016 for the fiscal year ended December 31, 2015. ・This document contains forward-looking statements based on a number of assumptions and beliefs held by management in light of information currently available. For a variety of reasons, actual financial results may differ materially from the forecasts presented here. ・Figures presented in this document have been rounded down to the nearest whole number. |
Index | Page |
I. Consolidated Financial Results | |
1.Trends in consolidated income | 1 |
2.Trends in results by segment | 2 |
3.Other trends | 3 |
II. Consolidated Balance Sheets | 4 |
III. Consolidated Cash Flows | 5 |
IV. Consolidated Subsidiaries and Affiliates | 6 |
V. Kyowa Hakko Kirin Sales of Main Products | 7 |
VI. Segment Information and Main Subsidiaries Operating Profit or Loss | |
1.Pharmaceuticals segment | 9 |
2.Bio-Chemicals segment | 10 |
VII. R&D Pipeline | 11 |
The average exchange rate for each period was as follows | Unit: yen |
Contact Kyowa Hakko Kirin Co., Ltd. Corporate Communications Department Tel 81 3 3282 0009 | |
Trends in consolidated income
Accumulative Billions of yen, rounded down
FY 2014 results
FY 2015 results
FY 2016 forecasts
Jan - Mar
Jan - Jun
Jan - Sep
Jan - Dec
Jan - Mar
%
Jan - Jun
%
Jan - Sep
%
Jan - Dec
Change Amount
%
Jan - Dec latest forecasts
% of forecasts
Jan - Jun
Change Amount
%
Jan - Dec
Change Amount
%
Net sales
86.0
161.8
238.9
333.4
89.5
104%
178.8
110%
272.9
114%
364.3
30.8
109%
360.0
101%
171.0
(7.8)
96%
351.0
(13.3)
96%
Gross Profit
51.2
98.2
146.5
205.9
51.9
101%
108.8
111%
170.4
116%
225.3
19.4
109%
-
-
-
-
-
-
-
-
Selling, general and administrative expenses
38.8
79.8
120.3
169.7
42.5
110%
86.3
108%
129.5
108%
181.6
11.8
107%
-
-
-
-
-
-
-
-
Operating income
(Prior to reverse acquisition amortization of goodwill)
14.7
23.0
33.2
45.4
11.6
79%
27.0
118%
47.8
144%
53.0
7.5
117%
56.2
94%
Operating income
12.4
18.4
26.2
36.1
9.3
75%
22.4
122%
40.8
156%
43.7
7.5
121%
47.0
93%
9.0
(13.4)
40%
30.0
(13.7)
69%
Non-operating income
1.0
1.6
1.5
2.3
1.1
115%
1.8
117%
2.7
179%
2.9
0.6
127%
-
-
-
-
-
-
-
-
Non-operating expenses
1.3
3.1
4.0
8.9
2.4
174%
4.2
135%
6.9
173%
7.4
(1.4)
84%
-
-
-
-
-
-
-
-
Ordinary income
12.0
16.8
23.8
29.5
8.0
67%
20.0
119%
36.6
154%
39.2
9.6
133%
41.0
96%
-
-
-
25.0
(14.2)
64%
Extraordinary income
0.3
0.3
0.3
0.3
0.6
201%
0.6
201%
7.5
-
8.1
7.8
-
-
-
-
-
-
-
-
-
Extraordinary loss
-
0.4
1.5
2.5
0.4
-
3.4
828%
3.5
234%
5.9
3.3
232%
-
-
-
-
-
-
-
-
Income before income taxes and minority interests
12.3
16.7
22.5
27.2
8.2
67%
17.2
103%
40.6
180%
41.4
14.1
152%
39.0
106%
-
-
-
26.0
(15.4)
63%
Income taxes
6.0
7.5
10.5
11.3
3.6
61%
7.6
102%
14.6
139%
11.6
0.2
102%
-
-
-
-
-
-
-
-
Net income
6.3
9.1
12.0
15.8
4.6
73%
9.5
104%
26.0
216%
29.7
13.8
187%
26.0
115%
-
-
-
16.0
(13.7)
54%
Comprehensive income
EPS prior to reverse acquisition amortization of goodwill (¥/share)
EPS prior to amortization of goodwill (¥/share)
ROE prior to amortization of goodwill (%)
3.8 6.6 15.1 27.2 3.0 78% 14.2 213% 22.2 147% 24.9 (2.2) 92% - - - - - - - -
15.80 25.24 34.67 45.95 12.65 80% 25.85 102% 60.27 174% 71.31 25.36 155% 64.41 111%
- - - 53.87 - -
4.8 7.1
1 "Prior to reverse acquisition amortization of goodwill" refers to profits prior to the deduction of amortization of the goodwill arising on the reverse acquisition in April 2008 (Kirin Pharma share transfer).
"Prior to amortization of goodwill" refers to profits prior to the deduction of all amortization of goodwill.
2 Throughout this document, "Jan - Dec latest forecasts" refers to the revised FY 2015 earnings forecasts announced on July 24, 2015.
Quarterly
Bllions of yen, rounded down
FY 2014 results
FY 2015 results
Jan - Mar
Apr - Jun
Jul - Sep
Oct - Dec
Jan - Mar
%
Apr - Jun
%
Jul - Sep
%
Oct - Dec
Change Amount
%
Net sales
86.0
75.8
77.0
94.5
89.5
104%
89.2
118%
94.1
122%
91.3
(3.1)
97%
Gross Profit
51.2
46.9
48.3
59.3
51.9
101%
56.9
121%
61.5
127%
54.9
(4.3)
93%
Selling, general and administrative expenses
38.8
40.9
40.5
49.4
42.5
110%
43.8
107%
43.1
107%
52.0
2.6
105%
Operating income
(Prior to reverse acquistion amortization of goodwill)
14.7
8.2
10.1
12.2
11.6
79%
15.4
187%
20.7
204%
5.1
(7.0)
43%
Operating income
12.4
5.9
7.8
9.8
9.3
75%
13.1
220%
18.4
234%
2.8
(7.0)
29%
Non-operating income
1.0
0.5
(0.0)
0.7
1.1
115%
0.7
119%
0.9
-
0.1
(0.6)
20%
Non-operating expenses
1.3
1.7
0.8
4.9
2.4
174%
1.8
105%
2.7
310%
0.5
(4.4)
10%
Ordinary income
12.0
4.8
6.9
5.7
8.0
67%
11.9
250%
16.6
239%
2.5
(3.1)
44%
Extraordinary income
0.3
-
-
-
0.6
201%
-
-
6.9
-
0.6
0.6
-
Extraordinary loss
-
0.4
1.0
1.0
0.4
-
3.0
729%
0.0
6%
2.4
1.3
229%
Income before income taxes and minority interests
12.3
4.3
5.8
4.6
8.2
67%
8.9
204%
23.4
402%
0.7
(3.9)
15%
Income taxes
6.0
1.5
2.9
0.7
3.6
61%
4.0
262%
6.9
233%
(3.0)
(3.8)
-
Net income
6.3
2.8
2.8
3.8
4.6
73%
4.9
172%
16.5
580%
3.7
(0.1)
97%
EPS prior to reverse acquisition amortization of goodwill (¥/share)
15.80 9.44 9.44 11.28 12.65 80% 13.21 140% 34.42 365% 11.04 (0.24) 98% -
Trends in results by segment
Reported segment Accumulative
Billions of yen, rounded down
FY 2014 results
FY 2015 results
FY 2016 forecasts
Jan - Mar
Jan - Jun
Jan - Sep
Jan - Dec
Jan - Mar
%
Jan - Jun
%
Jan - Sep
%
Jan - Dec
Change Amount
%
Jan - Dec
latest forecasts
% of forecasts
Jan - Jun
Change Amount
%
Jan - Dec
Change Amount
%
Net sales
86.0
161.8
238.9
333.4
89.5
104%
178.8
110%
272.9
114%
364.3
30.8
109%
360.0
101%
171.0
(7.8)
96%
351.0
(13.3)
96%
Pharmaceuticals
63.1
119.5
178.6
253.0
68.0
108%
135.3
113%
208.7
117%
279.2
26.2
110%
276.0
101%
129.0
(6.3)
95%
268.0
(11.2)
96%
Elimination of inter-segment sales
(0.2)
(0.5)
(0.8)
(1.1)
(0.2)
-
(0.4)
-
(0.6)
-
(0.8)
0.2
-
(1.0)
-
-
0.4
-
(1.0)
(0.1)
-
Bio-Chemicals
23.5
44.0
62.7
83.9
22.1
94%
45.0
102%
67.1
107%
88.8
4.9
106%
88.0
101%
43.0
(2.0)
96%
87.0
(1.8)
98%
Elimination of inter-segment sales
(0.3)
(1.1)
(1.6)
(2.4)
(0.3)
-
(1.0)
-
(2.2)
-
(2.9)
(0.5)
-
(3.0)
-
(1.0)
0.0
-
(3.0)
(0.0)
-
Operating income
12.4
18.4
26.2
36.1
9.3
75%
22.4
122%
40.8
156%
43.7
7.5
121%
47.0
93%
9.0
(13.4)
40%
30.0
(13.7)
69%
Prior to reverse acquistion goodwill amortization
14.7
23.0
33.2
45.4
11.6
79%
27.0
118%
47.8
144%
53.0
7.5
117%
56.2
94%
Pharmaceuticals
9.4
14.1
20.6
29.0
7.7
83%
18.5
131%
34.9
170%
36.2
7.1
125%
38.5
94%
5.2
(13.3)
28%
23.0
(13.2)
64%
11.5
18.4
27.0
37.6
9.9
86%
22.8
124%
41.4
153%
44.8
7.1
119%
47.1
95%
Bio-Chemicals
3.0
4.2
5.6
7.2
1.4
48%
3.9
95%
6.4
114%
8.1
0.8
112%
8.5
96%
3.8
(0.1)
95%
7.0
(1.1)
86%
3.2
4.5
6.1
7.9
1.6
50%
4.3
95%
6.9
112%
8.7
0.8
111%
9.1
96%
Total
12.4
18.4
26.2
36.3
9.2
74%
22.5
123%
41.3
157%
44.3
7.9
122%
47.0
94%
9.0
(13.5)
40%
30.0
(14.3)
68%
14.8
23.0
33.2
45.5
11.5
78%
27.1
118%
48.3
145%
53.5
7.9
118%
56.2
95%
Eliminations
(0.0)
0.0
(0.0)
(0.1)
0.0
-
(0.0)
-
(0.5)
-
(0.5)
(0.3)
-
-
-
-
0.0
-
-
0.5
-
Quarterly
Billions of yen, rounded down
FY 2014 results
FY 2015 results
Jan - Mar
Apr - Jun
Jul - Sep
Oct - Dec
Jan - Mar
%
Apr - Jun
%
Jul - Sep
%
Oct - Dec
Change Amount
%
Net sales
86.0
75.8
77.0
94.5
89.5
104%
89.2
118%
94.1
122%
91.3
(3.1)
97%
Pharmaceuticals
63.1
56.3
59.1
74.3
68.0
108%
67.2
119%
73.4
124%
70.5
(3.8)
95%
Elimination of inter-segment sales
(0.2)
(0.2)
(0.2)
(0.2)
(0.2)
-
(0.2)
-
(0.2)
-
(0.2)
0.0
-
Bio-Chemicals
23.5
20.4
18.7
21.2
22.1
94%
22.8
112%
22.0
118%
21.7
0.5
103%
Elimination of inter-segment sales
(0.3)
(0.7)
(0.5)
(0.7)
(0.3)
-
(0.7)
-
(1.1)
-
(0.6)
0.0
-
Operating income
12.4
5.9
7.8
9.8
9.3
75%
13.1
220%
18.4
234%
2.8
(7.0)
29%
Prior to reverse acquistion goodwill amortization
14.7
8.2
10.1
12.2
11.6
79%
15.4
187%
20.7
204%
5.1
(7.0)
43%
Pharmaceuticals
9.4
4.7
6.4
8.4
7.7
83%
10.7
227%
16.3
255%
1.2
(7.2)
15%
11.5
6.8
8.5
10.6
9.9
86%
12.9
187%
18.5
216%
3.4
(7.2)
32%
Bio-Chemicals
3.0
1.1
1.4
1.6
1.4
48%
2.5
217%
2.4
168%
1.6
0.0
105%
3.2
1.3
1.6
1.7
1.6
50%
2.6
203%
2.5
162%
1.8
0.0
105%
Total
12.4
5.9
7.8
10.0
9.2
74%
13.3
225%
18.8
239%
2.9
(7.1)
29%
14.8
8.2
10.1
12.3
11.5
78%
15.6
190%
21.1
207%
5.2
(7.1)
42%
Eliminations
(0.0)
0.0
(0.0)
(0.1)
0.0
-
(0.1)
-
(0.4)
-
(0.0)
0.1
-
Regional sales
- Consolidated Financial Results
Other trends
R&D Expenses
Billions of yen, rounded down
FY 2014 results
FY 2015 results
FY 2016 forecasts
Jan - Mar
Jan - Jun
Jan - Sep
Jan - Dec
Jan - Mar
Jan - Jun
Jan - Sep
Jan - Dec
Jan - Jun
Jan - Dec
R&D expenses
10.3
21.9
32.5
47.7
12.1
24.1
36.2
51.6
28.9
56.1
R&D to net sales ratio
12.0%
13.5%
13.6%
14.3%
13.5%
13.5%
13.3%
14.2%
17.0%
16.0%
Pharmaceuticals
9.5
20.2
30.0
44.0
11.3
22.5
33.8
48.3
27.1
52.6
R&D to net sales ratio
15.2%
16.9%
16.8%
17.4%
16.7%
16.7%
16.2%
17.3%
21.1%
19.6%
Bio-Chemicals
0.7
1.7
2.5
3.6
0.7
1.6
2.3
3.2
1.7
3.5
Capital Expenditure (Property, plant and equipment)
Billions of yen, rounded down
FY 2014 results
FY 2015 results
FY 2016 forecasts
Jan - Mar
Jan - Jun
Jan - Sep
Jan - Dec
Jan - Mar
Jan - Jun
Jan - Sep
Jan - Dec
Jan - Jun
Jan - Dec
Capital expenditure
5.3
12.1
20.9
27.2
5.6
10.2
13.3
19.0
11.1
27.7
Pharmaceuticals
Bio-Chemicals
2.8
2.4
6.5
5.5
11.5
9.4
14.8
12.4
2.2
3.3
4.6
5.6
6.9
6.3
10.5
8.4
7.2
3.9
16.0
11.6
Depreciation Expenses (Property, plant and equipment and Intangible assets) Billions of yen, rounded down
FY 2014 results
FY 2015 results
FY 2016 forecasts
Jan - Mar
Jan - Jun
Jan - Sep
Jan - Dec
Jan - Mar
Jan - Jun
Jan - Sep
Jan - Dec
Jan - Jun
Jan - Dec
Depreciation and amortization expenses
5.2
10.8
16.9
23.8
5.5
11.2
17.1
23.1
12.0
24.4
Amortization of intangible assets
1.9
3.9
6.2
8.9
2.6
5.1
7.7
10.2
4.9
9.8
Pharmaceuticals
3.6
7.6
12.0
17.0
4.0
8.1
12.3
16.5
8.5
17.5
Amortization of intangible assets
1.9
3.8
6.2
8.8
2.6
5.1
7.6
10.2
4.9
9.8
Bio-Chemicals
1.5
3.2
4.8
6.8
1.4
3.0
4.8
6.5
3.4
6.9
*Depreciation expenses for intangible assets do not include amortization of goodwill.
Amortization of Goodwill
-
Consolidated Balance Sheets
Billions of yen, rounded down
2013
2014
2015
Dec 31
Mar 31
Jun 30
Sep 30
Dec 31
Mar 31
Jun 30
Sep 30
Dec 31
Change previous year end
Assets
719.2
689.9
683.1
730.3
719.1
699.8
708.5
708.2
720.7
1.6
Current assets
329.3
300.8
296.0
295.7
283.1
270.3
278.0
307.4
324.4
41.2
Cash and deposits
20.1
17.2
15.5
17.3
20.6
16.5
16.2
17.2
13.2
(7.4)
Notes and accounts receivable-trade
98.6
102.9
93.4
91.2
108.8
106.2
105.2
100.7
106.8
(2.0)
Inventories
75.7
78.9
79.9
90.3
91.2
91.5
90.2
88.1
84.8
(6.4)
Deferred tax assets
10.4
10.2
10.3
10.6
10.6
10.2
10.2
9.8
11.1
0.5
Short-term loans receivable
113.1
85.1
89.6
77.7
41.6
36.2
45.1
80.0
96.1
54.4
Other
11.2
6.3
7.1
8.3
10.0
9.4
10.8
11.3
12.3
2.2
Non-current assets
389.9
389.0
387.0
434.6
435.9
429.5
430.5
400.7
396.3
(39.6)
Property, plant and equipment
137.9
139.4
142.2
148.2
151.8
154.5
152.9
149.8
147.0
(4.8)
Buildings and structures
42.2
41.3
42.0
41.9
44.4
45.5
48.2
49.0
49.4
4.9
Machinery, equipment and vehicles
21.0
21.5
21.6
22.0
22.1
25.8
30.4
29.6
30.6
8.4
Land
54.6
54.5
54.4
54.2
54.2
54.0
51.0
49.5
46.6
(7.5)
Other
20.0
21.9
24.0
29.9
30.9
29.0
23.2
21.6
20.3
(10.6)
Intangible assets
212.0
207.6
203.0
241.5
241.5
228.9
230.6
220.2
212.8
(28.7)
Goodwill
163.7
161.6
158.8
169.5
173.2
165.7
166.0
159.9
155.8
(17.3)
Sales rights
46.5
44.3
42.8
70.4
67.2
62.3
63.8
59.4
56.2
(10.9)
Other
1.8
1.6
1.4
1.4
1.0
0.8
0.8
0.7
0.7
(0.3)
Investments and other assets
39.9
41.9
41.7
44.8
42.5
46.0
46.9
30.6
36.4
(6.0)
Investment securities
24.6
23.4
23.1
24.4
22.7
27.6
28.4
11.6
14.0
(8.7)
Net defined benefit asset
-
-
-
-
6.4
5.8
6.1
6.5
6.9
0.5
Deferred tax assets
3.8
3.9
3.9
5.5
8.0
7.1
7.0
7.3
10.3
2.2
Other
11.4
14.5
14.6
14.8
5.2
5.3
5.2
5.0
5.1
(0.0)
Liabilities
123.8
98.4
88.8
134.4
113.7
100.0
97.5
96.0
105.9
(7.8)
Current liabilities
85.0
76.7
67.2
108.3
85.1
76.4
74.6
74.8
84.8
(0.3)
Notes and accounts payable-trade
22.5
26.0
17.5
21.6
22.7
24.5
17.2
16.3
19.0
(3.6)
Short-term loans payable
6.2
4.8
5.7
4.8
4.8
4.9
4.8
4.8
4.8
(0.0)
Accounts payable-other
36.5
27.3
28.3
31.8
39.2
29.9
35.4
30.8
39.8
0.6
Income taxes payable
10.4
5.4
7.2
5.9
7.7
4.4
8.7
10.3
11.8
4.1
Provision
1.8
5.5
1.5
5.8
2.7
5.5
2.0
6.3
2.7
0.0
Other
7.4
7.5
6.6
38.2
7.8
7.0
6.1
6.1
6.4
(1.4)
Non-current liabilities
38.7
21.7
21.6
26.0
28.5
23.5
22.9
21.2
21.0
(7.5)
Deferred tax liabilities
11.8
11.3
11.3
15.8
16.2
14.5
13.8
12.1
12.0
(4.1)
Net defined benefit liability
-
-
-
-
3.7
2.0
2.0
2.0
1.8
(1.8)
Provision
22.9
6.4
6.3
6.4
3.4
3.4
3.3
3.3
3.3
(0.1)
Other
3.9
3.9
3.9
3.8
5.1
3.5
3.6
3.6
3.7
(1.3)
Net assets
595.4
591.4
594.3
595.9
605.3
599.8
611.0
612.1
614.8
9.4
Shareholders' equity
578.3
577.8
580.6
576.6
580.4
576.8
581.7
591.3
594.9
14.4
Capital stock
26.7
26.7
26.7
26.7
26.7
26.7
26.7
26.7
26.7
-
Capital surplus
512.3
512.3
512.3
512.3
512.3
509.1
509.1
509.1
509.1
(3.1)
Retained earnings
65.8
65.3
68.2
64.2
68.1
67.6
72.5
82.2
85.9
17.8
Treasury shares
(26.6)
(26.5)
(26.6)
(26.6)
(26.6)
(26.6)
(26.7)
(26.8)
(26.8)
(0.2)
Accumulated other comprehensive income
15.6
13.3
13.3
18.9
24.5
22.6
28.9
20.4
19.4
(5.0)
Valuation difference on available-for-sale securities
1.4
1.2
1.4
2.2
2.7
5.1
5.0
2.2
2.9
0.2
Foreign currency translation adjustment
14.2
12.1
11.8
16.7
24.4
20.1
26.4
20.5
18.8
(5.5)
Remeasurements of defined benefit plans
-
-
-
-
(2.6)
(2.6)
(2.4)
(2.3)
(2.3)
0.2
Subscription rights to shares
0.3
0.2
0.3
0.3
0.3
0.3
0.3
0.3
0.4
0.0
Minority interests
1.1
-
-
-
-
-
-
-
-
-
Total liabilities and net assets
719.2
689.9
683.1
730.3
719.1
699.8
708.5
708.2
720.7
1.6
-
Consolidated Cash Flows
Billions of yen, rounded down
2013
2014
2015
Breakdown
Jan-Dec
Jan-Jun
Jan-Dec
Jan-Jun
Jan-Dec
Change
Cash flows from operating activities
56.8
(0.5)
19.3
22.9
66.5
47.1
Net income before taxes and minority interests
49.7
16.7
27.2
17.2
41.4
14.1
Net income
29.7
Tax expense
11.6
Depreciation
21.5
10.8
23.8
11.2
23.1
(0.7)
Property, plant and equipment
12.8
Intangible assets
10.2
Amortization of goodwill
11.5
6.0
12.8
6.6
13.4
0.6
Reverse acquisition amortization of goodwill
9.2
ProStrakan goodwill
4.1
Increase (decrease) in working capital
(5.6)
(4.6)
(20.1)
(0.5)
3.5
23.7
Changes in notes and accounts receivable-trade
1.0
Changes in inventories
5.4
Changes in notes and accounts payable-trade
(2.8)
Income taxes paid
(23.1)
(11.6)
(16.8)
(8.4)
(14.3)
2.4
Other
2.7
(17.9)
(7.5)
(3.2)
(0.6)
6.9
Cash flows from investing activities
(77.1)
1.6
16.8
(17.5)
(57.7)
(74.5)
Purchase of property, plant and equipment
(21.5)
(16.3)
(30.4)
(9.8)
(19.0)
11.4
Proceeds from sales of property, plant and equipment
1.7
0.1
0.1
0.0
3.0
2.8
Purchase of intangible assets
(13.1)
(1.9)
(4.1)
(0.0)
(1.0)
3.1
Purchase of investment securities
(3.8)
(1.1)
(4.5)
(5.2)
(6.7)
(2.1)
Proceeds from sales of investment securities
3.9
0.0
1.2
0.0
17.9
16.6
Proceeds from sales of shares of subsidiaries and associates
3.7
1.0
1.0
-
-
(1.0)
Purchase of shares of subsidiaries resulting in change in scope of consolidation
-
-
(14.5)
-
-
14.5
Net decrease (increase) in short- term loans receivable
(43.0)
20.4
68.3
(3.5)
(54.4)
(122.8)
Short-term loan receivable (exceeding 3 months) to Kirin Holdings
Other
(5.0)
(0.5)
(0.3)
1.0
2.4
2.7
Cash flows from financing activities
(12.5)
(7.8)
(37.1)
(7.1)
(14.0)
23.1
Net increase (decrease) of loans payable
0.0
(0.8)
(23.4)
(0.0)
0.0
23.4
Purchase of treasury shares
(0.1)
(0.0)
(0.1)
(0.1)
(0.2)
(0.1)
Cash dividends paid
(12.3)
(6.8)
(13.6)
(6.8)
(13.6)
0.0
Other
(0.1)
(0.0)
0.0
(0.0)
(0.1)
(0.2)
Effect of exchange rate change on cash and cash equivalents
1.7
(1.0)
(1.2)
(1.5)
1.0
2.2
Net increase (decrease) in cash and cash equivalents
(31.0)
(7.8)
(2.2)
(3.2)
(4.2)
(2.0)
Cash and cash equivalents at beginning of year
50.3
19.2
19.2
17.0
17.0
(2.2)
Cash and cash equivalents at end of year*
19.2
11.4
17.0
13.8
12.7
(4.2)
*Cash and cash deposits in the consolidated balance sheet, cash and cash equivalents at end of year in consolidated cash flows, and cash reserves at end of year
Cash and deposit accounts (consolidated balance sheet)
Fixed deposits in excess of three months
Short-term loans receivable to the parent company not exceeding three months
20.1 15.5 20.6 16.2 13.2 (7.4)
(3.4)
(3.3)
(3.7)
(2.4)
(0.4)
3.2
3.1
0.1
0.0
0.0
0.0
(0.0)
(0.6)
(0.9)
-
-
-
-
19.2
11.4
17.0
13.8
12.7
(4.2)
3.4
3.3
3.7
2.4
0.4
(3.2)
110.0
89.5
41.5
45.0
96.0
54.5
132.6
104.2
62.2
61.2
109.2
47.0
Current loans payable as negative cash equivalents (short-term loans payable) Cash and cash equivalents at end of year (consolidated cash flows)
Fixed deposits in excess of three months
Short-term loans receivable to the parent company in excess of three months
Cash reserves at end of year
Consolidated Subsidiaries and Affiliates
(As of December 31, 2015)
Segment
Type
Region
Company name
Percentage owned
Principal business
(direct and indirect)
Pharmaceuticals
Consolidated subsidiary
Japan
Kyowa Medex Co., Ltd.
100.0%
Manufacture and sale of diagnostic reagents
Kyowa Medical Promotion Co., Ltd.
100.0%
Promotion and sale of pharmaceuticals
Chiyoda Kaihatsu Co., Ltd.
100.0%
Contracting, wholesale and retail and insurance agency business
The Americas
Kyowa Hakko Kirin America, Inc.
100.0%
Supervision and management of subsidiaries (US)
BioWa, Inc.
100.0%
Out-licensing of anti-body technology (US)
Kyowa Hakko Kirin Pharma, Inc.
100.0%
Development of new candidate substances under contract (US)
Kyowa Hakko Kirin California, Inc.
100.0%
Generation of new candidate substances under contract and accelerating research collaborations (US)
ProStrakan Inc.
100.0%
Sale of pharmaceuticals (US)
Archimedes Pharma US Inc.
100.0%
Licensing of pharmaceuticals (US)
Europe
ProStrakan Group plc
100.0%
Supervision and management of special companies (UK)
Strakan International S.a r.l.
100.0%
Sale, licensing-in and licensing-out of pharmaceuticals (UK)
Strakan Pharmaceuticals Limited
100.0%
Development of pharmaceuticals (UK)
ProStrakan Limited
100.0%
Sale of pharmaceuticals (UK)
ProStrakan Pharma S.A.S 1
100.0%
Sale of pharmaceuticals (France)
Kyowa Kirin Farmacéutica SLU. 2
100.0%
Sale of pharmaceuticals (Spain)
ProStrakan Pharma GmbH 3
100.0%
Sale of pharmaceuticals (Germany)
ProStrakan Holdings B.V.
100.0%
Holding company for subsidiaries (Netherlands)
ProStrakan Pharma B.V.
100.0%
Sale of pharmaceuticals (Netherlands)
ProStrakan S.r.l.
100.0%
Sale of pharmaceuticals (Italy)
ProStrakan AB
100.0%
Sale of pharmaceuticals (Sweden)
Archimedes Pharma Limited
100.0%
Supervision and management of subsidiaries (UK)
Archimedes Development Limited
100.0%
Sale and development of pharmaceuticals (UK)
Archimedes Holdings Limited
100.0%
Holding company for subsidiaries (UK)
Archimedes Pharma Europe Limited
100.0%
Holding company for subsidiaries (UK)
Archimedes Pharma UK Limited
100.0%
Sale of pharmaceuticals (UK)
Archimedes Pharma Ibérica S.L.
100.0%
Sale of pharmaceuticals (Spain)
Archimedes Pharma Ireland Limited
100.0%
Sale of pharmaceuticals (Ireland)
Asia
Kyowa Hakko Kirin China Pharmaceutical Co., Ltd.
100.0%
Manufacture and sale of pharmaceuticals (China)
Kyowa Hakko Kirin Korea Co., Ltd.
100.0%
Sale of pharmaceuticals (Korea)
Kyowa Hakko Kirin (Taiwan) Co., Ltd.
100.0%
Sale of pharmaceuticals (Taiwan)
Kyowa Hakko Kirin (Hong Kong) Co., Ltd.
100.0%
Sale of pharmaceuticals (Hong Kong)
Kyowa Hakko Kirin (Singapore) Pte. Ltd.
100.0%
Research and sale of pharmaceuticals (Singapore)
Entity accounted for using equity method
Japan
FUJIFILM KYOWA KIRIN BIOLOGICS Co., Ltd.
50.0%
Development, manufacture and sale of biosimilar pharmaceuticals
Europe
Centus Biotherapeutics Limited 4
25.0%
Development and sale of biosimilar pharmaceuticals (UK)
Bio-Chemicals
Consolidated subsidiary
Japan
Kyowa Hakko Bio Co., Ltd.
100.0%
Manufacture and sale of pharmaceutical and industrial raw materials, and health care products
Kyowa Pharma Chemical Co., Ltd. 5
100.0%
Manufacture and sale of active pharmaceutical ingredients and pharmaceutical intermediates
Kyowa Engineering Co., Ltd.
100.0%
Design and installation of plant facilities and equipment
The Americas
BioKyowa Inc.
100.0%
Manufacture and sale of amino acids (US)
Kyowa Hakko U.S.A., Inc.
100.0%
Sale of fine chemicals including amino acids (US)
Kyowa Hakko Bio U.S. Holdings, Inc.
100.0%
Supervision and management of subsidiaries (US)
Europe
Kyowa Hakko Europe GmbH
100.0%
Sale of fine chemicals including amino acids (Germany)
Kyowa Hakko Bio Italia S.r.l.
100.0%
Sale of fine chemicals including amino acids (Italy)
Asia
Shanghai Kyowa Amino Acid Co., Ltd.
100.0%
Manufacture and sale of amino acids (China)
Thai Kyowa Biotechnologies Co., Ltd.
100.0%
Manufacture and sale of amino acids (Thailand)
Kyowa Hakko (H.K.) Co., Ltd.
100.0%
Sale of fine chemicals including amino acids (Hong Kong)
Kyowa Hakko Bio Singapore Pte. Ltd.
100.0%
Sale of fine chemicals including amino acids (Singapore)
Changes in major subsidiaries and affiliates (January 1, 2015 - December 31, 2015) New: Centus Biotherapeutics Limited (see note 4)
Exclusions: Archimedes Pharma France SAS (see note 1), Archimedes Pharma Germany GMBH (see note 3)
Notes:
On June 30, 2015, Archimedes Pharma France SAS was dissolved in a merger with ProStrakan Pharma S.A.S.
On July 3, 2015, ProStrakan Farmaceutica SLU changed its company name to "Kyowa Kirin Farmacéutica SLU."
On June 18, 2015, Archimedes Pharma Germany GMBH was dissolved in a merger with ProStrakan Pharma GmbH.
On December 1, 2015, Centus Biotherapeutics Limited became an equity method affiliate following an investment.
On October 1, 2015, Kyowa Pharma Chemical Co., Ltd.'s company name (trade name) was changed from DAIICHI FINE CHEMICAL CO., LTD.
- Kyowa Hakko Kirin Sales of Main Products
Pharmaceuticals segment total
Billions of yen, rounded down
FY 2014 results
FY 2015 results
FY2016 forecasts
Jan - Mar
Jan - Jun
Jan - Sep
Jan - Dec
Jan - Mar
%
Jan - Jun
%
Jan - Sep
%
Jan - Dec
Change Amount
%
Jan - Dec latest forecasts
% of forecasts
Jan - Jun
%
Jan - Dec
%
Net sales
63.1
119.5
178.6
253.0
68.0
108%
135.3
113%
208.7
117%
279.2
26.2
110%
276.0
101%
129.0
95%
268.0
96%
Japan sales
49.6
92.3
137.3
195.1
50.0
101%
100.1
108%
150.6
110%
204.9
9.8
105%
201.8
102%
95.2
95%
197.9
97%
Overseas sales
13.5
27.2
41.3
57.8
17.9
133%
35.1
129%
58.1
141%
74.3
16.4
128%
74.1
100%
33.7
96%
70.0
94%
America
3.4
7.2
10.3
13.4
4.8
140%
8.4
117%
11.6
113%
13.9
0.5
104%
13.8
101%
4.9
58%
12.2
88%
Europe
6.8
13.2
20.6
30.0
8.9
130%
18.1
137%
33.4
162%
42.4
12.4
141%
42.4
100%
20.1
111%
39.9
94%
Asia and others
3.1
6.6
10.4
14.3
4.1
130%
8.5
128%
13.0
125%
17.9
3.5
125%
17.8
101%
8.4
99%
17.5
98%
Operating income
9.4
14.1
20.6
29.0
7.7
83%
18.5
131%
34.9
170%
36.2
7.1
125%
38.5
94%
5.2
28%
23.0
64%
ProStrakan (GBP)
Millions of GBP, rounded down
FY 2014 results
FY 2015 results
FY2016 forecasts
Jan - Mar
Jan - Jun
Jan - Sep
Jan - Dec
Jan - Mar
%
Jan - Jun
%
Jan - Sep
%
Jan - Dec
Change Amount
%
Jan - Dec latest forecasts
% of forecasts
Jan - Jun
%
Jan - Dec
%
Net sales
38.4
78.0
125.3
181.4
53.7
140%
108.7
139%
163.7
131%
222.0
40.6
122%
220.1
101%
111.9
103%
226.1
102%
Cancer pain
Abstral
12.1
25.7
40.6
55.8
12.9
107%
27.5
107%
42.6
105%
60.0
4.2
108%
56.2
107%
29.8
109%
61.0
102%
Cancer pain
PecFent
-
-
2.4
7.5
5.4
-
10.9
-
16.9
687%
22.2
14.6
295%
24.3
91%
13.7
125%
27.6
124%
Anticancer
MitomycinC
3.8
7.0
10.7
14.6
4.6
120%
9.8
139%
14.6
137%
18.5
3.9
127%
16.7
111%
8.2
84%
16.5
89%
Chemotherapy-induced nausea and vomiting drug
Sancuso
2.7
6.3
10.0
14.0
3.9
140%
8.2
131%
12.7
128%
17.2
3.2
123%
18.2
95%
8.9
108%
19.1
111%
Replacement therapy with testosterone for male hypogonadism
Tostran
2.7
5.9
9.2
13.0
5.8
216%
9.2
154%
12.2
133%
17.5
4.4
134%
16.1
109%
5.7
63%
10.8
62%
Relief of pain associated with chronic anal fissures
Rectogesic
2.7
5.6
8.4
11.5
2.8
102%
5.4
96%
7.9
95%
10.3
(1.2)
89%
10.6
97%
4.9
90%
9.6
94%
Osteoporosis drug
Adcal-D3
7.1
13.9
21.3
29.3
6.7
94%
13.2
95%
20.3
95%
27.2
(2.0)
93%
27.8
98%
12.6
95%
26.3
97%
Others
4.0
8.2
17.2
29.8
11.1
274%
22.6
275%
34.2
199%
46.1
16.3
155%
48.0
96%
26.8
119%
53.0
115%
Product net sales (subtotal)
35.4
72.9
120.0
175.9
53.4
151%
107.2
147%
161.8
135%
219.5
43.5
125%
218.3
101%
111.0
104%
224.3
102%
Technology Out-Licensing and others
2.9
5.0
5.2
5.4
0.2
8%
1.4
29%
1.9
37%
2.5
(2.9)
46%
1.8
139%
0.8
60%
1.7
70%
Gross profit
28.8
58.7
91.0
129.1
38.9
135%
81.4
139%
121.2
133%
163.2
34.0
126%
161.7
101%
84.7
104%
166.9
102%
Selling, general and administrative expenses 1
16.6
33.0
51.2
74.5
20.8
125%
42.0
127%
61.6
120%
88.1
13.6
118%
85.6
103%
45.7
109%
89.4
101%
R&D expenses 1
1.2
2.1
3.8
5.5
1.6
137%
3.0
140%
5.0
132%
6.8
1.3
124%
5.3
128%
10.9
356%
21.0
307%
EBITDA 2
10.9
23.5
35.9
49.1
16.4
150%
36.2
154%
54.5
152%
68.2
19.1
139%
70.7
96%
28.1
78%
56.4
83%
Depreciation and amortization 1
9.9
19.9
33.2
49.2
15.4
155%
30.6
154%
46.4
139%
61.9
12.7
126%
61.9
100%
31.2
102%
62.5
101%
Operating income
1.0
3.5
2.6
(0.1)
1.0
105%
5.6
156%
8.1
304%
6.2
6.3
-
8.7
72%
(3.1)
-
(6.0)
-
1 R&D expenses, and Depreciation and amortization are not included in Selling, general and administrative expenses. 2 EBITDA ＝Operating income + depreciation + amortization
3 Archimedes was acquired by ProStrakan on August 5, 2014, and from August 2014, Archimedes' financial results have been consolidated with those of ProStrakan. 4 Geographical breakdown of sales for January - December 2015 is as follows:
UK
Europe (excluding UK)
USA
Other
32.6%
48.9%
15.9%
2.5%
Kyowa Medex Co., Ltd.
Bio-Chemicals segment total
Billions of yen, rounded down
FY 2014 results
FY 2015 results
FY 2016 forecasts
Jan - Mar
Jan - Jun
Jan - Sep
Jan - Dec
Jan - Mar
%
Jan - Jun
%
Jan - Sep
%
Jan - Dec
Change Amount
%
Jan - Dec latest forecasts
% of forecasts
Jan - Jun
%
Jan - Dec
%
Net sales
23.5
44.0
62.7
83.9
22.1
94%
45.0
102%
67.1
107%
88.8
4.9
106%
88.0
101%
43.0
96%
87.0
98%
Japan sales
12.9
25.1
35.2
47.6
12.1
94%
24.1
96%
36.7
104%
48.9
1.2
103%
48.5
101%
22.4
93%
46.3
95%
Overseas sales
10.6
18.8
27.4
36.3
10.0
94%
20.8
110%
30.3
110%
39.9
3.6
110%
39.5
101%
20.6
99%
40.7
102%
America
2.0
4.1
6.2
8.2
2.5
124%
5.2
127%
7.9
128%
10.2
1.9
123%
9.9
103%
5.4
102%
10.8
106%
Europe
4.1
8.0
12.0
15.6
4.3
103%
8.2
102%
12.0
101%
15.5
(0.1)
99%
15.0
104%
8.1
98%
15.4
99%
Asia and others
4.4
6.6
9.2
12.4
3.1
71%
7.3
110%
10.2
111%
14.2
1.8
115%
14.6
98%
7.1
97%
14.5
102%
Operating income
3.0
4.2
5.6
7.2
1.4
48%
3.9
95%
6.4
114%
8.1
0.8
112%
8.5
96%
3.8
95%
7.0
86%
Kyowa Hakko Bio Co., Ltd.
Billions of yen, rounded down
FY 2014 results
FY 2015 results
FY 2016 forecasts
Jan - Mar
Jan - Jun
Jan - Sep
Jan - Dec
Jan - Mar
%
Jan - Jun
%
Jan - Sep
%
Jan - Dec
Change Amount
%
Jan - Dec latest forecasts
% of forecasts
Jan - Jun
%
Jan - Dec
%
Net sales
17.3
31.5
44.5
58.0
14.1
82%
31.0
99%
45.8
103%
60.9
2.8
105%
61.4
99%
30.6
99%
60.8
100%
Japan sales
9.9
19.1
27.1
35.7
8.7
89%
18.1
95%
27.1
100%
36.0
0.3
101%
36.4
99%
17.1
94%
34.6
96%
Pharmaceutical
5.5
10.7
15.1
19.8
4.3
78%
9.4
88%
14.1
93%
19.3
(0.4)
98%
19.2
101%
9.0
96%
18.3
95%
and health food
materials
Consumer
product
(mail order etc.)
1.3
2.8
4.4
6.1
1.4
107%
3.2
111%
4.9
112%
6.8
0.6
111%
6.8
100%
3.4
108%
7.3
108%
Other
2.9
5.5
7.5
9.8
2.9
100%
5.5
100%
8.0
106%
9.9
0.1
101%
10.3
96%
4.5
83%
8.9
90%
Exports
7.4
12.3
17.3
22.3
5.4
73%
12.9
104%
18.6
107%
24.8
2.4
111%
25.0
99%
13.5
105%
26.2
106%
Operating income
2.7
3.6
4.7
5.6
1.3
48%
2.9
81%
4.4
94%
5.9
0.3
106%
6.2
95%
2.8
96%
5.3
89%
Note: Japan sales volumes are displayed using different categories than those previously. Past results use figures after reclassification.
Kyowa Pharma Chemical Co., Ltd. *
Billions of yen, rounded down
FY 2014 results | FY 2015 results | FY 2016 forecasts | ||||||||||||||||
Jan - Mar | Jan - Jun | Jan - Sep | Jan - Dec | Percentage of consolidated sales | Jan - Mar | Percentage of consolidated sales | Jan - Jun | Percentage of consolidated sales | Jan - Sep | Percentage of consolidated sales | Jan - Dec | Percentage of consolidated sales | Jan - Jun | Percentage of consolidated sales | Jan - Dec | Percentage of consolidated sales | ||
Japan sales | 61.8 | 115.7 | 170.0 | 239.2 | 71.7% | 61.6 | 68.8% | 122.8 | 68.7% | 184.4 | 67.6% | 249.9 | 68.6% | 116.6 | 68.2% | 240.2 | 68.4% | |
Overseas sales | 24.2 | 46.1 | 68.8 | 94.2 | 28.3% | 27.9 | 31.2% | 56.0 | 31.3% | 88.4 | 32.4% | 114.3 | 31.4% | 54.3 | 31.8% | 110.7 | 31.6% | |
America | 5.5 | 11.4 | 16.5 | 21.6 | 6.5% | 7.4 | 8.3% | 13.7 | 7.7% | 19.5 | 7.2% | 24.1 | 6.6% | 10.3 | 6.0% | 23.0 | 6.6% | |
Europe | 11.0 | 21.3 | 32.6 | 45.7 | 13.7% | 13.2 | 14.8% | 26.3 | 14.7% | 45.5 | 16.7% | 57.9 | 15.9% | 28.2 | 16.5% | 55.3 | 15.8% | |
Asia | 7.3 | 12.8 | 19.0 | 25.8 | 7.8% | 7.0 | 7.9% | 15.4 | 8.6% | 22.6 | 8.3% | 31.0 | 8.5% | 15.2 | 8.9% | 31.5 | 9.0% | |
Other regions | 0.2 | 0.4 | 0.6 | 0.9 | 0.3% | 0.2 | 0.3% | 0.4 | 0.3% | 0.6 | 0.3% | 1.0 | 0.3% | 0.4 | 0.2% | 0.8 | 0.2% | |
Total consolidated net sales | 86.0 | 161.8 | 238.9 | 333.4 | 100% | 89.5 | 100% | 178.8 | 100% | 272.9 | 100% | 364.3 | 100% | 171.0 | 100% | 351.0 | 100% | |
* Sales classified by region or country based on location of customer.
Billions of yen, rounded down
FY 2014 results | FY 2015 results | FY 2016 forecasts | |||||||||
Jan - Mar | Jan - Jun | Jan - Sep | Jan - Dec | Jan - Mar | Jan - Jun | Jan - Sep | Jan - Dec | Jan - Jun | Jan - Dec | ||
Amortization expenses | 3.0 | 6.0 | 9.3 | 12.8 | 3.3 | 6.6 | 10.0 | 13.4 | 6.7 | 13.4 | |
Reverse acquisition amortization of goodwill | 2.3 | 4.6 | 6.9 | 9.2 | 2.3 | 4.6 | 6.9 | 9.2 | |||
Pharmaceuticals | 2.8 | 5.6 | 8.6 | 11.8 | 3.1 | 6.3 | 9.6 | 12.8 | 6.4 | 12.8 | |
Reverse acquisition amortization of goodwill | 2.1 | 4.3 | 6.4 | 8.6 | 2.1 | 4.3 | 6.4 | 8.6 | |||
Bio-Chemicals | 0.2 | 0.4 | 0.6 | 0.9 | 0.1 | 0.3 | 0.4 | 0.6 | 0.3 | 0.6 | |
Reverse acquisition amortization of goodwill | 0.1 | 0.3 | 0.4 | 0.6 | 0.1 | 0.3 | 0.4 | 0.6 | |||
*"Reverse acquisition amortization of goodwill" refers to amortization of goodwill arising on the reverse acquisition in April 2008 (Kirin Pharma share transfer).
Accumulative
Billions of yen, rounded down
FY 2014 results | FY 2015 results | FY2016 forecasts | |||||||||||||||||
Jan - Mar | Jan - Jun | Jan - Sep | Jan - Dec | Jan - Mar | % | Jan - Jun | % | Jan - Sep | % | Jan - Dec | Change Amount | % | Jan - Dec latest forecasts | % of forecasts | Jan - Jun | % | Jan - Dec | % | |
Kyowa Hakko Kirin total | 52.1 | 97.0 | 143.1 | 201.7 | 53.8 | 103% | 105.9 | 109% | 163.6 | 114% | 217.9 | 16.1 | 108% | 215.7 | 101% | 97.7 | 92% | 200.4 | 92% |
Indication / Product name | |||||||||||||||||||
ESA formulation | 12.1 | 25.9 | 40.1 | 55.3 | 12.3 | 101% | 27.0 | 105% | 42.0 | 105% | 57.5 | 2.1 | 104% | 56.9 | 101% | 26.8 | 99% | 54.6 | 95% |
Nesp | |||||||||||||||||||
ESA formulation | 0.6 | 1.2 | 1.8 | 2.4 | 0.4 | 71% | 0.9 | 75% | 1.4 | 78% | 1.9 | (0.4) | 79% | 1.8 | 103% | 0.7 | 79% | 1.4 | 78% |
Espo | |||||||||||||||||||
Secondary hyperparathyroidism | 4.5 | 7.6 | 11.7 | 16.3 | 3.9 | 85% | 8.5 | 112% | 13.2 | 113% | 18.2 | 1.8 | 111% | 17.7 | 102% | 9.1 | 106% | 18.9 | 104% |
Regpara | |||||||||||||||||||
Secondary hyperparathyroidism | 1.1 | 2.1 | 3.3 | 4.6 | 1.0 | 97% | 2.4 | 113% | 3.7 | 112% | 5.1 | 0.4 | 109% | 4.8 | 105% | 1.7 | 71% | 3.3 | 65% |
Rocaltrol | |||||||||||||||||||
Type-2 diabetes | 0.0 | 0.1 | 0.4 | 1.2 | 0.8 | - | 2.0 | - | 3.2 | 789% | 4.8 | 3.5 | 387% | 4.7 | 102% | 3.2 | 160% | 6.9 | 145% |
Onglyza | |||||||||||||||||||
Cardiovascular (Hypertension & angina pectoris) | 3.2 | 6.2 | 9.0 | 12.0 | 2.4 | 75% | 5.0 | 81% | 7.4 | 82% | 10.0 | (2.0) | 83% | 9.6 | 104% | 3.8 | 76% | 7.4 | 74% |
Coniel | |||||||||||||||||||
Cardiovascular (Hypertension) | 0.7 | 1.4 | 2.1 | 2.8 | 0.5 | 81% | 1.2 | 85% | 1.8 | 87% | 2.5 | (0.3) | 87% | 2.4 | 104% | 0.9 | 76% | 1.8 | 75% |
Coversyl | |||||||||||||||||||
Sustained-duration G-CSF | - | - | - | 0.3 | 1.4 | - | 3.8 | - | 6.7 | - | 10.3 | 9.9 | - | 8.9 | 115% | 6.9 | 181% | 15.0 | 146% |
G-Lasta | |||||||||||||||||||
G-CSF | 2.0 | 4.4 | 6.7 | 9.2 | 1.3 | 64% | 2.8 | 65% | 4.4 | 65% | 5.9 | (3.3) | 64% | 5.7 | 103% | 1.7 | 60% | 3.3 | 56% |
Gran | |||||||||||||||||||
Transdermal persistent pain | 1.1 | 2.6 | 4.1 | 5.9 | 1.2 | 109% | 2.8 | 109% | 4.4 | 106% | 6.1 | 0.2 | 104% | 6.4 | 95% | 3.0 | 108% | 6.5 | 106% |
Fentos | |||||||||||||||||||
Anticancer | 0.2 | 0.6 | 1.1 | 1.5 | 0.4 | 183% | 1.0 | 146% | 1.4 | 127% | 1.9 | 0.3 | 125% | 2.0 | 95% | 0.8 | 87% | 1.9 | 97% |
Poteligeo | |||||||||||||||||||
Anticancer | 0.5 | 1.1 | 1.8 | 2.4 | 0.5 | 100% | 1.1 | 101% | 1.7 | 99% | 2.3 | (0.1) | 96% | 2.1 | 111% | 0.6 | 56% | 1.1 | 50% |
5-FU | |||||||||||||||||||
Chronic idiopathic | 0.5 | 1.2 | 1.9 | 2.7 | 0.6 | 109% | 1.3 | 115% | 2.1 | 113% | 3.0 | 0.3 | 111% | 2.8 | 106% | 1.4 | 107% | 3.1 | 104% |
thrombocytopenic purpura | |||||||||||||||||||
Romiplate | |||||||||||||||||||
Antiallergenic | 8.4 | 13.4 | 17.9 | 23.6 | 7.8 | 92% | 12.4 | 93% | 16.8 | 94% | 22.1 | (1.5) | 93% | 20.5 | 107% | 11.0 | 89% | 18.1 | 82% |
Allelock | |||||||||||||||||||
Antiallergic eyedrops | 7.1 | 8.1 | 9.9 | 11.8 | 7.4 | 105% | 8.8 | 108% | 10.7 | 108% | 12.8 | 0.9 | 108% | 11.9 | 107% | 9.2 | 105% | 12.2 | 96% |
Patanol | |||||||||||||||||||
Inflammatory bowel disease | 1.5 | 2.7 | 4.2 | 5.9 | 1.3 | 91% | 2.9 | 107% | 4.5 | 106% | 6.1 | 0.1 | 102% | 6.3 | 96% | 2.5 | 87% | 4.9 | 81% |
Asacol | |||||||||||||||||||
Psoriasis vulgaris | - | - | 0.3 | 1.1 | 0.9 | - | 2.1 | - | 3.3 | - | 4.7 | 3.5 | 402% | 4.8 | 98% | 2.8 | 129% | 5.4 | 114% |
Dovobet | |||||||||||||||||||
Parkinson's disease | 0.2 | 0.8 | 1.7 | 2.8 | 0.9 | 350% | 2.2 | 263% | 3.6 | 216% | 5.3 | 2.5 | 191% | 5.5 | 97% | 3.2 | 142% | 6.9 | 130% |
Nouriast | |||||||||||||||||||
Antiepileptic | 2.3 | 4.6 | 6.9 | 9.4 | 2.0 | 88% | 4.2 | 92% | 6.4 | 92% | 8.7 | (0.7) | 92% | 8.7 | 99% | 3.9 | 92% | 7.7 | 89% |
Depakene | |||||||||||||||||||
Gastrointestinal | 1.0 | 1.9 | 2.7 | 3.8 | 0.8 | 84% | 1.7 | 89% | 2.5 | 91% | 3.5 | (0.3) | 91% | 3.5 | 101% | 1.4 | 86% | 2.8 | 81% |
Nauzelin | |||||||||||||||||||
Technology Out-Licensing | 2.0 | 4.1 | 6.4 | 13.9 | 1.7 | 82% | 3.7 | 90% | 11.3 | 176% | 11.9 | (2.0) | 85% | 12.8 | 93% | 2.0 | 54% | 7.3 | 61% |
FY 2014 results | FY 2015 results | ||||||||||||
Jan - Mar | Apr - Jun | Jul - Sep | Oct - Dec | Jan - Mar | % | Apr - Jun | % | Jul - Sep | % | Oct - Dec | Change Amount | % | |
Kyowa Hakko Kirin total | 52.1 | 44.8 | 46.1 | 58.6 | 53.8 | 103% | 52.1 | 116% | 57.6 | 125% | 54.3 | (4.3) | 93% |
Indication / Product name | |||||||||||||
ESA formulation | 12.1 | 13.7 | 14.2 | 15.2 | 12.3 | 101% | 14.7 | 108% | 14.9 | 105% | 15.4 | 0.2 | 102% |
Nesp | |||||||||||||
ESA formulation | 0.6 | 0.6 | 0.5 | 0.5 | 0.4 | 71% | 0.5 | 79% | 0.5 | 84% | 0.4 | (0.0) | 85% |
Espo | |||||||||||||
Secondary hyperparathyroidism | 4.5 | 3.0 | 4.0 | 4.6 | 3.9 | 85% | 4.6 | 151% | 4.6 | 114% | 4.9 | 0.3 | 108% |
Regpara | |||||||||||||
Secondary hyperparathyroidism | 1.1 | 1.0 | 1.1 | 1.3 | 1.0 | 97% | 1.3 | 130% | 1.3 | 111% | 1.3 | 0.0 | 103% |
Rocaltrol | |||||||||||||
Type-2 diabetes | 0.0 | 0.1 | 0.2 | 0.8 | 0.8 | - | 1.1 | - | 1.2 | 448% | 1.5 | 0.7 | 185% |
Onglyza | |||||||||||||
Cardiovascular (Hypertension & angina pectoris) | 3.2 | 2.9 | 2.8 | 3.0 | 2.4 | 75% | 2.6 | 88% | 2.4 | 86% | 2.5 | (0.4) | 85% |
Coniel | |||||||||||||
Cardiovascular (Hypertension) | 0.7 | 0.7 | 0.6 | 0.7 | 0.5 | 81% | 0.6 | 88% | 0.6 | 91% | 0.6 | (0.0) | 89% |
Coversyl | |||||||||||||
Sustained-duration G-CSF | - | - | - | 0.3 | 1.4 | - | 2.4 | - | 2.8 | - | 3.6 | 3.2 | 912% |
G-Lasta | |||||||||||||
G-CSF | 2.0 | 2.3 | 2.3 | 2.4 | 1.3 | 64% | 1.5 | 66% | 1.5 | 65% | 1.4 | (0.9) | 60% |
Gran | |||||||||||||
Transdermal persistent pain | 1.1 | 1.4 | 1.5 | 1.7 | 1.2 | 109% | 1.5 | 108% | 1.5 | 102% | 1.7 | (0.0) | 100% |
Fentos | |||||||||||||
Anticancer | 0.2 | 0.4 | 0.4 | 0.4 | 0.4 | 183% | 0.5 | 126% | 0.4 | 98% | 0.5 | 0.0 | 118% |
Poteligeo | |||||||||||||
Anticancer | 0.5 | 0.6 | 0.6 | 0.6 | 0.5 | 100% | 0.6 | 101% | 0.5 | 95% | 0.5 | (0.0) | 87% |
5-FU | |||||||||||||
Chronic idiopathic | 0.5 | 0.6 | 0.7 | 0.7 | 0.6 | 109% | 0.7 | 120% | 0.8 | 110% | 0.8 | 0.0 | 106% |
thrombocytopenic purpura | |||||||||||||
Romiplate | |||||||||||||
Antiallergenic | 8.4 | 4.9 | 4.5 | 5.6 | 7.8 | 92% | 4.6 | 93% | 4.4 | 97% | 5.2 | (0.4) | 92% |
Allelock | |||||||||||||
Antiallergic eyedrops | 7.1 | 1.0 | 1.7 | 1.9 | 7.4 | 105% | 1.3 | 124% | 1.9 | 108% | 2.0 | 0.1 | 109% |
Patanol | |||||||||||||
Inflammatory bowel disease | 1.5 | 1.2 | 1.5 | 1.7 | 1.3 | 91% | 1.5 | 128% | 1.5 | 105% | 1.6 | (0.1) | 93% |
Asacol | |||||||||||||
Psoriasis vulgaris | - | - | 0.3 | 0.8 | 0.9 | - | 1.2 | - | 1.1 | 374% | 1.4 | 0.5 | 162% |
Dovobet | |||||||||||||
Parkinson's disease | 0.2 | 0.5 | 0.8 | 1.1 | 0.9 | 350% | 1.2 | 221% | 1.4 | 168% | 1.6 | 0.5 | 153% |
Nouriast | |||||||||||||
Antiepileptic | 2.3 | 2.3 | 2.2 | 2.4 | 2.0 | 88% | 2.2 | 95% | 2.1 | 94% | 2.2 | (0.1) | 92% |
Depakene | |||||||||||||
Gastrointestinal | 1.0 | 0.9 | 0.8 | 1.1 | 0.8 | 84% | 0.8 | 95% | 0.7 | 97% | 1.0 | (0.1) | 91% |
Nauzelin | |||||||||||||
Technology Out-Licensing | 2.0 | 2.0 | 2.2 | 7.5 | 1.7 | 82% | 2.0 | 97% | 7.6 | 332% | 0.6 | (6.9) | 8% |
Billions of yen, rounded down
FY 2014 results | FY 2015 results | FY 2016 forecasts | |||||||||||||||||||
Jan - Mar | Jan - Jun | Jan - Sep | Jan - Dec | Jan - Mar | % | Jan - Jun | % | Jan - Sep | % | Jan - Dec | Change Amount | % | Jan - Dec latest forecasts | % of forecasts | Jan - Jun | % | Jan - Dec | % | |||
Net sales | 2.6 | 5.7 | 8.4 | 11.7 | 2.5 | 95% | 5.5 | 98% | 8.5 | 101% | 11.7 | 0.0 | 100% | 11.9 | 99% | 5.7 | 102% | 12.1 | 103% | ||
Japan sales | 2.1 | 4.6 | 7.0 | 9.7 | 2.1 | 99% | 4.6 | 100% | 7.0 | 100% | 9.8 | 0.1 | 101% | 10.0 | 98% | 4.7 | 102% | 10.1 | 103% | ||
Biochemical Diagnostic Reagent | 0.8 | 1.9 | 2.9 | 4.0 | 0.8 | 99% | 1.8 | 99% | 2.9 | 99% | 4.0 | (0.0) | 99% | 4.0 | 98% | 1.8 | 100% | 4.0 | 101% | ||
Immunological Diagnostic Reagent | 1.0 | 2.3 | 3.4 | 4.7 | 0.9 | 94% | 2.2 | 98% | 3.4 | 100% | 4.8 | 0.1 | 102% | 4.8 | 100% | 2.5 | 110% | 5.3 | 108% | ||
Other | 0.2 | 0.4 | 0.6 | 0.8 | 0.2 | 115% | 0.4 | 110% | 0.6 | 112% | 0.9 | 0.0 | 104% | 1.0 | 89% | 0.3 | 71% | 0.8 | 87% | ||
Exports | 0.5 | 1.0 | 1.4 | 2.0 | 0.4 | 80% | 0.9 | 91% | 1.5 | 106% | 1.9 | (0.0) | 95% | 1.8 | 103% | 0.9 | 103% | 2.0 | 103% | ||
Operating income | 0.0 | 0.3 | 0.4 | 0.7 | 0.0 | 83% | 0.3 | 93% | 0.4 | 103% | 0.8 | 0.0 | 107% | 0.9 | 84% | 0.0 | 2% | 0.4 | 62% | ||
2. Bio-Chemicals segment
Billions of yen, rounded down
FY 2014 results | FY 2015 results | FY 2016 forecasts | |||||||||||||||||
Jan - Mar | Jan - Jun | Jan - Sep | Jan - Dec | Jan - Mar | % | Jan - Jun | % | Jan - Sep | % | Jan - Dec | Change Amount | % | Jan - Dec latest forecasts | % of forecasts | Jan - Jun | % | Jan - Dec | % | |
Net sales | 3.5 | 6.9 | 9.4 | 13.3 | 3.5 | 100% | 6.6 | 96% | 10.4 | 111% | 13.7 | 0.3 | 103% | 13.3 | 103% | 5.7 | 87% | 11.7 | 86% |
Operating income | (0.0) | (0.0) | (0.1) | 0.3 | 0.1 | - | 0.7 | - | 1.3 | - | 1.7 | 1.3 | 456% | 1.7 | 100% | 0.3 | 51% | 0.7 | 44% |
* On October 1, 2015, Kyowa Pharma Chemical Co., Ltd.'s company name (trade name) was changed from DAIICHI FINE CHEMICAL CO., LTD.
Area | Code Name Generic Name Formulation | Mechanism of Action | Indication | Stage | In-House or Licensed | Remarks | |
Nephrology | KRN321 Darbepoetin Alfa Injection | Long-Acting Erythropoiesis Stimulating Agent | Renal Anemia (on Dialysis) | Filed in CN | Kirin-Amgen | ||
Oncology | Granisetron Patch | ５-HT3 Serotonin Receptor Antagonist | Chemotherapy induced Nausea and Vomiting | Filed in MY | Licensed from Solasia Pharma (ProStrakan) | Launched by ProStrakan as Sancuso® | |
Immunology /Allergy | ◎KHK4827 Brodalumab Injection | Anti-IL-17 Receptor Fully Human Antibody | Psoriasis | Filed in JP | Kirin-Amgen | ||
Other | AMG531 Romiplostim Injection | Thrombopoietin Receptor Agonist | Idiopathic (Immune) Thrombocytopenic Purpura | Filed in TH, MY | Kirin-Amgen |
Phase Ⅱ, Phase Ⅲ
Area | Code Name Generic Name Formulation | Mechanism of Action | Indication | Stage | In-House or Licensed | Remarks | |
Nephrology | ◎RTA 402 Bardoxolone Methyl Oral | Antioxidant Inflammation Modulator | CKD in Patients with Type 2 Diabetes | PhaseⅡ in JP | Licensed from Reata | ||
◎KHK7580 Oral | Calcium Receptor Agonist | Secondary Hyperparathyroidism | PhaseⅢ in JP | Licensed from Mitsubishi Tanabe Pharma | |||
Oncology | ◎ARQ 197 Tivantinib Oral | c-Met Inhibitor | Hepatocellular Cancer | Phase Ⅲ in JP | Licensed from ArQule | ||
◎BIW-8962 Injection | Anti-GM2 Humanized Antibody | Cancer | Phase Ⅰ/Ⅱa in KR | In-House | POTELLIGENT® | ||
KW-0761 Mogamulizumab Injection | Anti-CCR4 Humanized Antibody | Adult T-cell Leukemia/Lymphoma | Phase Ⅱ in US, EU and others | In-House | POTELLIGENT® | ||
Cutaneous T-cell Lymphoma | Phase Ⅲ in US, EU, JP and others | ||||||
Immunology /Allergy | ◎KHK4563 Benralizumab Injection | Anti-IL-5 Receptor Humanized Antibody | Asthma | Phase Ⅲ in JP and KR | In-House | POTELLIGENT® Jointly Developed with AstraZeneca/MedImmune in JP and KR | |
Chronic Obstructive Pulmonary Disease(COPD) | Phase Ⅲ in JP | ||||||
◎ASKP1240 Injection | Anti-CD40 Fully Human Antibody | Organ Transplant Rejection | Phase Ⅰin JP | In-House | Human Antibody-Producing mouse Jointly Developed with Astellas | ||
Phase Ⅱin US | |||||||
Z-206 Mesalazine Oral | pH Dependent Controlled Release Tablet | Ulcerative Colitis | Phase Ⅲ in JP | Licensed from Zeria Pharma | Jointly Developed with Zeria Pharma The Phase Ⅲ study is conducted to seek a new dose regimen | ||
Central Nervous System | KW-6002 Istradefylline Oral | Adenosine A2A Receptor Antagonist | Parkinson's Disease | Phase Ⅲ in US, CA, EU and others | In-House | ||
Other | ◎KRN23 Injection | Anti-FGF23 Fully Human Antibody | X-linked Hypophosphatemia(XLH) in adult patients | Phase Ⅲ in US, CA, EU, JP and KR | In-House | Human Antibody-Producing mouse Jointly Developed with Ultragenyx in US and EU | |
X-linked Hypophosphatemia (XLH) in pediatric patients | Phase Ⅱ in US and EU | ||||||
Tumor Induced Osteomalacia(TIO)/Epidermal Nevus Syndrome (ENS) | Phase Ⅱ in US | ||||||
AMG531 Romiplostim Injection | Thrombopoietin Receptor Agonist | Aplastic Anemia | PhaseⅡ in KR | Kirin-Amgen | |||
Idiopathic (Immune) Thrombocytopenic Purpura | Phase Ⅲ in CN |
Updated since Oct. 21, 2015 （Area, Stage, Filed, Approved, etc.）
◎ New Molecular Entity
Area | Code Name Generic Name Formulation | Mechanism of Action | Indication | Stage | In-House or Licensed | Remarks | ||
Oncology | ◎KRN951 Tivozanib Oral | VEGF Receptor Inhibitor | Cancer | PhaseⅠ in JP | In-House | Being Developed Overseas by AVEO as AV-951 | ||
◎KHK2375 Entinostat Oral | HDAC Inhibitor | Breast Cancer | PhaseⅠ in JP | Syndax | ||||
◎KHK2898 Injection | Anti-CD98 Fully Human Antibody | Cancer | Phase Ⅰ in SG | In-House | POTELLIGENT® Human Antibody-Producing mouse | |||
◎KHK2823 Injection | Anti-CD123 Fully Human Antibody | Cancer | Phase Ⅰ in UK | In-House | POTELLIGENT® Human Antibody-Producing mouse | |||
KW-0761 Mogamulizumab Injection | Anti-CCR4 Humanized Antibody | Solid Tumor | Phase Ⅰ in US | In-House | POTELLIGENT® | |||
Combination with Durvalumab/Tremelimumab (Jointly Developed with AstraZeneca) | ||||||||
Combination with Docetaxel | ||||||||
Combination with PF-05082566 (Jointly Developed with Pfizer) | ||||||||
PhaseⅠ in JP | Combination with Nivolumab (Jointly Developed with Ono Pharmaceutical / Bristol-Myers Squibb) | |||||||
Immunology /Allergy | ◎KHK4083 Injection | Immunomodulator Antibody | Autoimmune diseases | PhaseⅠ in CA | In-House | POTELLIGENT® Human Antibody-Producing mouse | ||
Central Nervous System | ◎KHK6640 Injection | Anti-Amyloid Beta Peptide Antibody | Alzheimer's Disease | PhaseⅠin EU | Licensed from Immunas Pharma | |||
PhaseⅠin JP | ||||||||
Others | KW-3357 Antithrombin Gamma Injection | Recombinant Human Antithrombin | Disseminated Intravascular Coagulation, Congenital Antithrombin Deficiency | Phase Ⅰin EU | In-House | |||
Updated since Oct. 21, 2015 （Area, Stage, Filed, Approved, etc.）
◎ New Molecular Entity
Area | Code Name Generic Name Formulation | Mechanism of Action | Indication | Stage | In-House or Licensed | Remarks |
Other | AMG531 Romiplostim Injection | Thrombopoietin Receptor Agonist | Idiopathic (Immune) Thrombocytopenic Purpura | Filed in MY | Kirin-Amgen |
Area | Code Name Generic Name Formulation | Mechanism of Action | Indication | Stage | In-House or Licensed | Remarks | |
Nephrology | ◎KHK7580 Oral | Calcium Receptor Agonist | Secondary Hyperparathyroidism | PhaseⅢ in JP | Licensed from Mitsubishi Tanabe Pharma | ||
Other | ◎KRN23 Injection | Anti-FGF23 Fully Human Antibody | X-linked Hypophosphatemia(XLH) in adult patients | Phase Ⅲ in US, CA, EU, JP and KR | In-House | Human Antibody-Producing mouse Jointly Developed with Ultragenyx in US and EU |
Area | Code Name Generic Name Formulation | Mechanism of Action | Indication | Stage | In-House or Licensed | Remarks |
Oncology | ◎KHK2375 Entinostat Oral | HDAC Inhibitor | Breast Cancer | PhaseⅠ in JP | Syndax |
Terminated
Area | Code Name Generic Name Formulation | Mechanism of Action | Indication | Stage | In-House or Licensed | Remarks | |
Oncology | ◎KHK2804/ CEP-37250 Injection | Anti-Tumor Specific Glycoprotein Humanized Antibody | Cancer | Phase Ⅰ in US | Licensed from Teva | POTELLIGENT® Jointly Developed with Teva | |
KW-0761 Mogamulizumab Injection | Anti-CCR4 Humanized Antibody | Peripheral T-cell Lymphoma | Phase Ⅱ in EU | In-House | POTELLIGENT® |
Code Name | Generic Name | Stage | Remarks |
FKB327 | Adalimumab （fully human anti-TNF-α monoclonal antibody） | Phase Ⅲ in US and others | Fujifilm Kyowa Kirin Biologics |
Code Name | Generic Name | Stage | Remarks |
FKB238 | Bevacizumab （humanized anti-VEGF monoclonal antibody） | Phase Ⅰ in UK | Centus Biotherapeutics |
Kyowa Hakko Kirin Co. Ltd. issued this content on 29 January 2016 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 29 January 2016 06:53:04 UTC
Original Document: http://www.kyowa-kirin.com/news_releases/2016/pdf/e20160129_03.pdf
