Kyowa Hakko Kirin : Appendix to the Consolidated Financial Summary Fiscal 2015 Third Quarter(255KB)

October 28, 2015 at 12:55 am EDT

Appendix to the Consolidated Financial Summary Fiscal 2015 Third Quarter

October 28, 2015

Kyowa Hakko Kirin Co., Ltd.

Appendix to the Consolidated Financial Summary Fiscal 2015 Third Quarter

(January 1, 2015 - September 30, 2015)

・This document was made as a supplement to the Kessan Tanshin (financial report), disclosed at the Tokyo Stock Exchange on October 28, 2015 for the third quarter of Fiscal 2015, the nine-month period from January 1, 2015 to September 30, 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

Consolidated Financial Results
Trends in consolidated income 1
Trends in results by segment 2
Other trends 3
Consolidated Balance Sheets 4
Consolidated Subsidiaries and Affiliates 5
Kyowa Hakko Kirin Sales of Main Products 6
Segment Information and Main Subsidiaries Operating Profit or Loss 1.Pharmaceuticals segment 8
2.Bio-Chemicals segment 9
R&D Pipeline 10

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

Consolidated Financial Results

Trends in consolidated income

Accumulative Billions of yen, rounded down

FY 2014 results				FY 2015 results									FY 2015 forecasts
Jan - Mar	Jan - Jun	Jan - Sep	Jan - Dec	Jan - Mar	%	Jan - Jun	%	Jan - Sep	Change Amount	%	Jan - Dec	%	Jan - Dec	%
Net sales	86.0	161.8	238.9	333.4	89.5	104%	178.8	110%	272.9	34.0	114%	-	-	360.0	108%
Gross Profit	51.2	98.2	146.5	205.9	51.9	101%	108.8	111%	170.4	23.8	116%	-	-	-	-
Selling, general and administrative expenses	38.8	79.8	120.3	169.7	42.5	110%	86.3	108%	129.5	9.2	108%	-	-	-	-
Operating income (prior to amortization of goodwill)	14.7	23.0	33.2	45.4	11.6	79%	27.0	118%	47.8	14.6	144%	-	-	56.2	124%
Operating income	12.4	18.4	26.2	36.1	9.3	75%	22.4	122%	40.8	14.6	156%	-	-	47.0	130%
Non-operating income Non-operating expenses	1.0 1.3	1.6 3.1	1.5 4.0	2.3 8.9	1.1 2.4	115% 174%	1.8 4.2	117% 135%	2.7 6.9	1.2 2.9	179% 173%	- -	- -	- -	- -
Ordinary income	12.0	16.8	23.8	29.5	8.0	67%	20.0	119%	36.6	12.8	154%	-	-	41.0	139%
Extraordinary income Extraordinary loss	0.3 -	0.3 0.4	0.3 1.5	0.3 2.5	0.6 0.4	201% -	0.6 3.4	201% 828%	7.5 3.5	7.2 2.0	- 234%	- -	- -	- -	- -
Income before income taxes and minority interests	12.3	16.7	22.5	27.2	8.2	67%	17.2	103%	40.6	18.0	180%	-	-	39.0	143%
Income taxes	6.0	7.5	10.5	11.3	3.6	61%	7.6	102%	14.6	4.0	139%	-	-	-	-
Net income	6.3	9.1	12.0	15.8	4.6	73%	9.5	104%	26.0	14.0	216%	-	-	26.0	164%

3.8	6.6 15.1 27.2 3.0 78% 14.2 213% 22.2	7.0 147%	- - -	-
15.80	25.24 34.67 45.95 12.65 80% 25.85 102% 60.27	25.60 174%	- - 64.41	140%

Comprehensive income

EPS prior to amortization of goodwill (¥/share)

1 'Prior to 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).
(Note: This adjustment does not include goodwill amortization in respect of the acquisition of ProStrakan.)
2 The FY 2015 forecasts are the revised forecasts announced on July 24, 2015.

FY 2014 results				FY 2015 results
Jan - Mar	Apr - Jun	Jul - Sep	Oct - Dec	Jan - Mar	%	Apr - Jun	%	Jul - Sep	Change Amount	%	Oct - Dec	%
Net sales	86.0	75.8	77.0	94.5	89.5	104%	89.2	118%	94.1	17.0	122%	-	-
Gross Profit	51.2	46.9	48.3	59.3	51.9	101%	56.9	121%	61.5	13.1	127%	-	-
Selling, general and administrative expenses	38.8	40.9	40.5	49.4	42.5	110%	43.8	107%	43.1	2.6	107%	-	-
Operating income (Prior to amortization of goodwill)	14.7	8.2	10.1	12.2	11.6	79%	15.4	187%	20.7	10.5	204%	-	-
Operating income	12.4	5.9	7.8	9.8	9.3	75%	13.1	220%	18.4	10.5	234%	-	-
Non-operating income Non-operating expenses	1.0 1.3	0.5 1.7	(0.0) 0.8	0.7 4.9	1.1 2.4	115% 174%	0.7 1.8	119% 105%	0.9 2.7	0.9 1.8	- 310%	- -	- -
Ordinary income	12.0	4.8	6.9	5.7	8.0	67%	11.9	250%	16.6	9.6	239%	-	-
Extraordinary income Extraordinary loss	0.3 -	- 0.4	- 1.0	- 1.0	0.6 0.4	201% -	- 3.0	- 729%	6.9 0.0	6.9 (1.0)	- 6%	- -	- -
Income before income taxes and minority interestses	12.3	4.3	5.8	4.6	8.2	67%	8.9	204%	23.4	17.6	402%	-	-
Income taxes	6.0	1.5	2.9	0.7	3.6	61%	4.0	262%	6.9	3.9	233%	-	-
Net income	6.3	2.8	2.8	3.8	4.6	73%	4.9	172%	16.5	13.6	580%	-	-

Quarterly

Bllions of yen, rounded down

EPS prior to amortization of goodwill (¥/share)

15.80 9.44 9.44 11.28 12.65 80% 13.21 140% 34.42 24.98 365% - -

I. Consolidated Financial Results

Trends in results by segment

Reported segment Accumulative

Billions of yen, rounded down

FY 2014 results				FY 2015 results									FY 2015 forecasts
Jan - Mar	Jan - Jun	Jan - Sep	Jan - Dec	Jan - Mar	%	Jan - Jun	%	Jan - Sep	Change Amount	%	Jan - Dec	%	Jan - Dec	%
Net sales		86.0	161.8	238.9	333.4	89.5	104%	178.8	110%	272.9	34.0	114%	-	-	360.0	108%
Pharmaceuticals	63.1	119.5	178.6	253.0	68.0	108%	135.3	113%	208.7	30.0	117%	-	-	276.0	109%
Elimination of inter-segment sales	(0.2)	(0.5)	(0.8)	(1.1)	(0.2)	-	(0.4)	-	(0.6)	0.2	-	-	-	(1.0)	-
Bio-Chemicals	23.5	44.0	62.7	83.9	22.1	94%	45.0	102%	67.1	4.3	107%	-	-	88.0	105%
Elimination of inter-segment sales	(0.3)	(1.1)	(1.6)	(2.4)	(0.3)	-	(1.0)	-	(2.2)	(0.6)	-	-	-	(3.0)	-
Operating income		12.4	18.4	26.2	36.1	9.3	75%	22.4	122%	40.8	14.6	156%	-	-	47.0	130%
Before goodwill amortization		14.7	23.0	33.2	45.4	11.6	79%	27.0	118%	47.8	14.6	144%	-	-	56.2	124%
Pharmaceuticals	9.4	14.1	20.6	29.0	7.7	83%	18.5	131%	34.9	14.3	170%	-	-	38.5	132%
11.5	18.4	27.0	37.6	9.9	86%	22.8	124%	41.4	14.3	153%	-	-	47.1	125%
Bio-Chemicals	3.0	4.2	5.6	7.2	1.4	48%	3.9	95%	6.4	0.7	114%	-	-	8.5	117%
Bio-Chemicals	3.2	4.5	6.1	7.9	1.6	50%	4.3	95%	6.9	0.7	112%	-	-	9.1	115%
Total	12.4	18.4	26.2	36.3	9.2	74%	22.5	123%	41.3	15.1	157%	-	-	47.0	129%
Total	14.8	23.0	33.2	45.5	11.5	78%	27.1	118%	48.3	15.1	145%	-	-	56.2	123%
Eliminations	(0.0)	0.0	(0.0)	(0.1)	0.0	-	(0.0)	-	(0.5)	(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	Change Amount	%	Oct - Dec	%
Net sales		86.0	75.8	77.0	94.5	89.5	104%	89.2	118%	94.1	17.0	122%	-	-
Pharmaceuticals	63.1	56.3	59.1	74.3	68.0	108%	67.2	119%	73.4	14.2	124%	-	-
Elimination of inter-segment sales	(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	3.3	118%	-	-
Elimination of inter-segment sales	(0.3)	(0.7)	(0.5)	(0.7)	(0.3)	-	(0.7)	-	(1.1)	(0.6)	-	-	-
Operating income		12.4	5.9	7.8	9.8	9.3	75%	13.1	220%	18.4	10.5	234%	-	-
Before goodwill amortization		14.7	8.2	10.1	12.2	11.6	79%	15.4	187%	20.7	10.5	204%	-	-
Pharmaceuticals	9.4	4.7	6.4	8.4	7.7	83%	10.7	227%	16.3	9.9	255%	-	-
11.5	6.8	8.5	10.6	9.9	86%	12.9	187%	18.5	9.9	216%	-	-
Bio-Chemicals	3.0	1.1	1.4	1.6	1.4	48%	2.5	217%	2.4	0.9	168%	-	-
Bio-Chemicals	3.2	1.3	1.6	1.7	1.6	50%	2.6	203%	2.5	0.9	162%	-	-
Total	12.4	5.9	7.8	10.0	9.2	74%	13.3	225%	18.8	10.9	239%	-	-
Total	14.8	8.2	10.1	12.3	11.5	78%	15.6	190%	21.1	10.9	207%	-	-
Eliminations	(0.0)	0.0	(0.0)	(0.1)	0.0	-	(0.1)	-	(0.4)	(0.4)	-	-	-

Regional sales

Billions of yen, rounded down

FY 2014 results								FY 2015 results
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 - Mar	Percentage of consolidated sales	Jan - Jun	Percentage of consolidated sales	Jan - Sep	Percentage of consolidated sales	Jan - Dec	Percentage of consolidated sales
Japan sales		61.8	71.9%	115.7	71.5%	170.0	71.2%	239.2	71.7%	61.6	68.8%	122.8	68.7%	184.4	67.6%	-	-
Overseas sales		24.2	28.1%	46.1	28.5%	68.8	28.8%	94.2	28.3%	27.9	31.2%	56.0	31.3%	88.4	32.4%	-	-
America	5.5	6.4%	11.4	7.1%	16.5	6.9%	21.6	6.5%	7.4	8.3%	13.7	7.7%	19.5	7.2%	-	-
Europe	11.0	12.8%	21.3	13.2%	32.6	13.7%	45.7	13.7%	13.2	14.8%	26.3	14.7%	45.5	16.7%	-	-
Asia	7.3	8.5%	12.8	8.0%	19.0	8.0%	25.8	7.8%	7.0	7.9%	15.4	8.6%	22.6	8.3%	-	-
Other regions	0.2	0.3%	0.4	0.3%	0.6	0.3%	0.9	0.3%	0.2	0.3%	0.4	0.3%	0.6	0.3%	-	-
Total consolidated net sales		86.0	100%	161.8	100%	238.9	100%	333.4	100%	89.5	100%	178.8	100%	272.9	100%	-	-

* Sales classified by region or country based on location of customer.

Consolidated Financial Results

Other trends

R&D Expenses

Billions of yen, rounded down

FY 2014 results				FY 2015 results				FY 2015 forecasts
Jan - Mar	Jan - Jun	Jan - Sep	Jan - Dec	Jan - Mar	Jan - Jun	Jan - Sep	Jan - Dec	Jan - Dec
R&D expenses		10.3	21.9	32.5	47.7	12.1	24.1	36.2	-	51.6
R&D to net sales ratio		12.0%	13.5%	13.6%	14.3%	13.5%	13.5%	13.3%	-	14.3%
Pharmaceuticals	9.5	20.2	30.0	44.0	11.3	22.5	33.8	-	48.2
R&D to net sales ratio	15.2%	16.9%	16.8%	17.4%	16.7%	16.7%	16.2%	-	17.5%
Bio-Chemicals	0.7	1.7	2.5	3.6	0.7	1.6	2.3	-	3.3

Capital Expenditure (Property, plant and equipment)

Billions of yen, rounded down

FY 2014 results				FY 2015 results				FY 2015 forecasts
Jan - Mar	Jan - Jun	Jan - Sep	Jan - Dec	Jan - Mar	Jan - Jun	Jan - Sep	Jan - Dec	Jan - Dec
Capital expenditure		5.3	12.1	20.9	27.2	5.6	10.2	13.3	-	22.0
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	- -	11.8 10.2

Depreciation Expenses (Property, plant and equipment and Intangible assets) Billions of yen, rounded down

FY 2014 results				FY 2015 results				FY 2015 forecasts
Jan - Mar	Jan - Jun	Jan - Sep	Jan - Dec	Jan - Mar	Jan - Jun	Jan - Sep	Jan - Dec	Jan - Dec
Depreciation and amortization expenses		5.2	10.8	16.9	23.8	5.5	11.2	17.1	-	22.7
Amortization of intangible assets		1.9	3.9	6.2	8.9	2.6	5.1	7.7	-	10.0
Pharmaceuticals	3.6	7.6	12.0	17.0	4.0	8.1	12.3	-	16.3
Amortization of intangible assets	1.9	3.8	6.2	8.8	2.6	5.1	7.6	-	10.0
Bio-Chemicals	1.5	3.2	4.8	6.8	1.4	3.0	4.8	-	6.4

*Depreciation expenses for intangible assets do not include amortization of goodwill.

Amortization of Goodwill

Billions of yen, rounded down

FY 2014 results				FY 2015 results				FY 2015 forecasts
Jan - Mar	Jan - Jun	Jan - Sep	Jan - Dec	Jan - Mar	Jan - Jun	Jan - Sep	Jan - Dec	Jan - Dec
Amortization expenses		3.0	6.0	9.3	12.8	3.3	6.6	10.0	-	13.3
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	-	12.7
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
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).

Consolidated Balance Sheets

Billions of yen, rounded down

2013	2014				2015
Dec 31	Mar 31	June 30	Sep 30	Dec 31	Mar 31	June 30	Sep 30	Change previous year end	Dec 31
Assets				719.2	689.9	683.1	730.3	719.1	699.8	708.5	708.2	(10.9)	-
Current assets			329.3	300.8	296.0	295.7	283.1	270.3	278.0	307.4	24.2	-
Cash and deposits		20.1	17.2	15.5	17.3	20.6	16.5	16.2	17.2	(3.3)	-
Notes and accounts receivable-trade		98.6	102.9	93.4	91.2	108.8	106.2	105.2	100.7	(8.1)	-
Inventories		75.7	78.9	79.9	90.3	91.2	91.5	90.2	88.1	(3.1)	-
Deferred tax assets		10.4	10.2	10.3	10.6	10.6	10.2	10.2	9.8	(0.7)	-
Short-term loans receivable		113.1	85.1	89.6	77.7	41.6	36.2	45.1	80.0	38.3	-
Other		11.2	6.3	7.1	8.3	10.0	9.4	10.8	11.3	1.2	-
Non-current assets			389.9	389.0	387.0	434.6	435.9	429.5	430.5	400.7	(35.2)	-
Property, plant and equipment		137.9	139.4	142.2	148.2	151.8	154.5	152.9	149.8	(2.0)	-
Buildings and structures	42.2	41.3	42.0	41.9	44.4	45.5	48.2	49.0	4.5	-
Machinery, equipment and vehicles	21.0	21.5	21.6	22.0	22.1	25.8	30.4	29.6	7.4	-
Land	54.6	54.5	54.4	54.2	54.2	54.0	51.0	49.5	(4.7)	-
Other	20.0	21.9	24.0	29.9	30.9	29.0	23.2	21.6	(9.3)	-
Intangible assets		212.0	207.6	203.0	241.5	241.5	228.9	230.6	220.2	(21.3)	-
Goodwill	163.7	161.6	158.8	169.5	173.2	165.7	166.0	159.9	(13.2)	-
Sales rights	46.5	44.3	42.8	70.4	67.2	62.3	63.8	59.4	(7.7)	-
Other	1.8	1.6	1.4	1.4	1.0	0.8	0.8	0.7	(0.2)	-
Investments and other assets		39.9	41.9	41.7	44.8	42.5	46.0	46.9	30.6	(11.8)	-
Investment securities	24.6	23.4	23.1	24.4	22.7	27.6	28.4	11.6	(11.0)	-
Net defined benefit asset	-	-	-	-	6.4	5.8	6.1	6.5	0.1	-
Deferred tax assets	3.8	3.9	3.9	5.5	8.0	7.1	7.0	7.3	(0.7)	-
Other	11.4	14.5	14.6	14.8	5.2	5.3	5.2	5.0	(0.1)	-
Liabilities				123.8	98.4	88.8	134.4	113.7	100.0	97.5	96.0	(17.7)	-
Current liabilities			85.0	76.7	67.2	108.3	85.1	76.4	74.6	74.8	(10.3)	-
Notes and accounts payable-trade		22.5	26.0	17.5	21.6	22.7	24.5	17.2	16.3	(6.3)	-
Short-term loans payable		6.2	4.8	5.7	4.8	4.8	4.9	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	(8.4)	-
Income taxes payable		10.4	5.4	7.2	5.9	7.7	4.4	8.7	10.3	2.6	-
Provision		1.8	5.5	1.5	5.8	2.7	5.5	2.0	6.3	3.6	-
Other		7.4	7.5	6.6	38.2	7.8	7.0	6.1	6.1	(1.7)	-
Non-current liabilities			38.7	21.7	21.6	26.0	28.5	23.5	22.9	21.2	(7.3)	-
Deferred tax liabilities		11.8	11.3	11.3	15.8	16.2	14.5	13.8	12.1	(4.0)	-
Net defined benefit liability		-	-	-	-	3.7	2.0	2.0	2.0	(1.6)	-
Provision		22.9	6.4	6.3	6.4	3.4	3.4	3.3	3.3	(0.0)	-
Other		3.9	3.9	3.9	3.8	5.1	3.5	3.6	3.6	(1.5)	-
Net assets				595.4	591.4	594.3	595.9	605.3	599.8	611.0	612.1	6.7	-
Shareholders' equity			578.3	577.8	580.6	576.6	580.4	576.8	581.7	591.3	10.8	-
Capital stock		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	(3.2)	-
Retained earnings		65.8	65.3	68.2	64.2	68.1	67.6	72.5	82.2	14.1	-
Treasury shares		(26.6)	(26.5)	(26.6)	(26.6)	(26.6)	(26.6)	(26.7)	(26.8)	(0.1)	-
Accumulated other comprehensive income			15.6	13.3	13.3	18.9	24.5	22.6	28.9	20.4	(4.1)	-
Valuation difference on available-for-sale securities		1.4	1.2	1.4	2.2	2.7	5.1	5.0	2.2	(0.4)	-
Foreign currency translation adjustment		14.2	12.1	11.8	16.7	24.4	20.1	26.4	20.5	(3.9)	-
Remeasurements of defined benefit plans		-	-	-	-	(2.6)	(2.6)	(2.4)	(2.3)	0.3	-
Subscription rights to shares			0.3	0.2	0.3	0.3	0.3	0.3	0.3	0.3	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	(10.9)	-

Consolidated Subsidiaries and Affiliates

(As of September 30, 2015)

Segment	Type	Region	Company name	Percentage owned (direct and indirect)	Principal business
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 sales 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%	Sales 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 Inernational S.a r.l.	100.0%	Sales, licensing-in and licensing-out of pharmaceuticals (UK)
			Strakan Pharmaceuticals Limited	100.0%	Development of pharmaceuticals (UK)
			ProStrakan Limited	100.0%	Sales of pharmaceuticals (UK)
			ProStrakan Pharma S.A.S *1	100.0%	Sales of pharmaceuticals (France)
			Kyowa Kirin Farmacéutica SLU. *2	100.0%	Sales of pharmaceuticals (Spain)
			ProStrakan Pharma GmbH *3	100.0%	Sales of pharmaceuticals (Germany)
			ProStrakan Holdings B.V.	100.0%	Holding company for subsidiaries (Netherlands)
			ProStrakan Pharma B.V.	100.0%	Sales of pharmaceuticals (Netherlands)
			ProStrakan S.r.l.	100.0%	Sales of pharmaceuticals (Italy)
			ProStrakan AB	100.0%	Sales of pharmaceuticals (Sweden)
			Archimedes Pharma Limited	100.0%	Supervision and management of subsidiaries (UK)
			Archimedes Development Limited	100.0%	Sales 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%	Sales of pharmaceuticals (UK)
			Archimedes Pharma Ibérica S.L.	100.0%	Sales of pharmaceuticals (Spain)
			Archimedes Pharma Ireland Limited	100.0%	Sales 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%	Sales of pharmaceuticals (Korea)
			Kyowa Hakko Kirin (Taiwan) Co., Ltd.	100.0%	Sales of pharmaceuticals (Taiwan)
			Kyowa Hakko Kirin (Hong Kong) Co., Ltd.	100.0%	Sales 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
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
			DAIICHI FINE CHEMICAL CO., LTD.*4	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)
		Europe	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 scope of consolidation resulting in changes in subsidiaries (January 1, 2015 - September 30, 2015) New: None

Exclusions: 2: 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 October 1, 2015, DAIICHI FINE CHEMICAL CO., LTD. changed its company name (trade name) to 'Kyowa Pharma Chemical Co., Ltd.
Kyowa Hakko Kirin Sales of Main Products

Accumulative

Billions of yen, rounded down

FY 2014 results

FY 2015 results

FY2015

forecasts

Jan - Mar

Jan - Jun

Jan - Sep

Jan - Dec

Jan - Mar

Jan - Jun

Jan - Sep

Change amount

Jan - Dec

Kyowa Hakko Kirin total

52.1

97.0

143.1

201.7

53.8

103%

105.9

109%

163.6

20.5

114%

215.7

107%

Indication / Product name

ESA formulation

Nesp

12.1

25.9

40.1

55.3

12.3

101%

27.0

105%

42.0

1.9

105%

56.9

103%

ESA formulation

Espo

0.6

1.2

1.8

2.4

0.4

71%

0.9

75%

1.4

(0.4)

78%

1.8

77%

Secondary hyperparathyroidism

Regpara

4.5

7.6

11.7

16.3

3.9

85%

8.5

112%

13.2

1.4

113%

17.7

109%

Secondary hyperparathyroidism

Rocaltrol

1.1

2.1

3.3

4.6

1.0

97%

2.4

113%

3.7

0.4

112%

4.8

104%

Type-2 diabetes

Onglyza

0.0

0.1

0.4

1.2

0.8

2.0

3.2

2.8

789%

4.7

379%

Cardiovascular (Hypertension & angina pectoris)

Coniel

3.2

6.2

9.0

12.0

2.4

75%

5.0

81%

7.4

(1.5)

82%

9.6

80%

Cardiovascular (Hypertension)

Coversyl

0.7

1.4

2.1

2.8

0.5

81%

1.2

85%

1.8

(0.2)

87%

2.4

84%

Sustained-duration G-CSF

G-Lasta

0.3

1.4

3.8

6.7

8.9

G-CSF

Gran

2.0

4.4

6.7

9.2

1.3

64%

2.8

65%

4.4

(2.3)

65%

5.7

62%

Transdermal persistent pain

Fentos

1.1

2.6

4.1

5.9

1.2

109%

2.8

109%

4.4

0.2

106%

6.4

109%

Anticancer

Poteligeo

0.2

0.6

1.1

1.5

0.4

183%

1.0

146%

1.4

0.3

127%

2.0

132%

Anticancer

5-FU

0.5

1.1

1.8

2.4

0.5

100%

1.1

101%

1.7

(0.0)

99%

2.1

86%

Anticancer

Navelbine

0.2

0.4

0.6

0.8

0.1

84%

0.3

86%

0.5

(0.0)

87%

0.7

83%

Chronic idiopathic thrombocytopenic purpura

Romiplate

0.5

1.2

1.9

2.7

0.6

109%

1.3

115%

2.1

0.2

113%

2.8

105%

Antiallergenic

Allelock

8.4

13.4

17.9

23.6

7.8

92%

12.4

93%

16.8

(1.0)

94%

20.5

87%

Antiallergic eyedrops

Patanol

7.1

8.1

9.9

11.8

7.4

105%

8.8

108%

10.7

0.7

108%

11.9

101%

Inflammatory bowel disease

Asacol

1.5

2.7

4.2

5.9

1.3

91%

2.9

107%

4.5

0.2

106%

6.3

106%

Psoriasis vulgaris

Dovobet

0.3

1.1

0.9

2.1

3.3

3.0

4.8

412%

Parkinson's disease

Nouriast

0.2

0.8

1.7

2.8

0.9

350%

2.2

263%

3.6

1.9

216%

5.5

197%

Antiepileptic

Depakene

2.3

4.6

6.9

9.4

2.0

88%

4.2

92%

6.4

(0.5)

92%

8.7

93%

Gastrointestinal

Nauzelin

1.0

1.9

2.7

3.8

0.8

84%

1.7

89%

2.5

(0.2)

91%

3.5

90%

Technology Out-Licensing

2.0

4.1

6.4

13.9

1.7

82%

3.7

90%

11.3

4.9

176%

12.8

92%

Kyowa Hakko Kirin Sales of Main Products

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

Change amount

Oct - Dec

Kyowa Hakko Kirin total

52.1

44.8

46.1

58.6

53.8

103%

52.1

116%

57.6

11.5

125%

Indication / Product name

ESA formulation

Nesp

12.1

13.7

14.2

15.2

12.3

101%

14.7

108%

14.9

0.7

105%

ESA formulation

Espo

0.6

0.5

0.4

71%

0.5

79%

0.5

(0.0)

84%

Secondary hyperparathyroidism

Regpara

4.5

3.0

4.0

4.6

3.9

85%

4.6

151%

4.6

0.5

114%

Secondary hyperparathyroidism

Rocaltrol

1.1

1.0

1.1

1.3

1.0

97%

1.3

130%

1.3

0.1

111%

Type-2 diabetes

Onglyza

0.0

0.1

0.2

0.8

1.1

1.2

0.9

448%

Cardiovascular (Hypertension & angina pectoris)

Coniel

3.2

2.9

2.8

3.0

2.4

75%

2.6

88%

2.4

(0.4)

86%

Cardiovascular (Hypertension)

Coversyl

0.7

0.6

0.7

0.5

81%

0.6

88%

0.6

(0.0)

91%

Sustained-duration G-CSF

G-Lasta

0.3

1.4

2.4

2.8

G-CSF

Gran

2.0

2.3

2.4

1.3

64%

1.5

66%

1.5

(0.8)

65%

Transdermal persistent pain

Fentos

1.1

1.4

1.5

1.7

1.2

109%

1.5

108%

1.5

0.0

102%

Anticancer

Poteligeo

0.2

0.4

183%

0.5

126%

0.4

(0.0)

98%

Anticancer

5-FU

0.5

0.6

0.5

100%

0.6

101%

0.5

(0.0)

95%

Anticancer

Navelbine

0.2

0.1

84%

0.1

88%

0.1

(0.0)

91%

Chronic idiopathic thrombocytopenic purpura Romiplate

0.5

0.6

0.7

0.6

109%

0.7

120%

0.8

0.0

110%

Antiallergenic

Allelock

8.4

4.9

4.5

5.6

7.8

92%

4.6

93%

4.4

(0.1)

97%

Antiallergic eyedrops

Patanol

7.1

1.0

1.7

1.9

7.4

105%

1.3

124%

1.9

0.1

108%

Inflammatory bowel disease

Asacol

1.5

1.2

1.5

1.7

1.3

91%

1.5

128%

1.5

0.0

105%

Psoriasis vulgaris

Dovobet

0.3

0.8

0.9

1.2

1.1

0.8

374%

Parkinson's disease

Nouriast

0.2

0.5

0.8

1.1

0.9

350%

1.2

221%

1.4

0.5

168%

Antiepileptic

Depakene

2.3

2.2

2.4

2.0

88%

2.2

95%

2.1

(0.1)

94%

Gastrointestinal

Nauzelin

1.0

0.9

0.8

1.1

0.8

84%

0.8

95%

0.7

(0.0)

97%

Technology Out-Licensing

2.0

2.2

7.5

1.7

82%

2.0

97%

7.6

5.3

332%

Segment information and Main Subsidiaries Operating Profit or Loss
Pharmaceuticals segment

Pharmaceuticals segment total

Billions of yen, rounded down

FY 2014 results				FY 2015 results									FY 2015 forecasts
Jan - Mar	Jan - Jun	Jan - Sep	Jan - Dec	Jan - Mar	%	Jan - Jun	%	Jan - Sep	Change Amount	%	Jan - Dec	%	Jan - Dec	%
Net sales			63.1	119.5	178.6	253.0	68.0	108%	135.3	113%	208.7	30.0	117%	-	-	276.0	109%
Japan sales		49.6	92.3	137.3	195.1	50.0	101%	100.1	108%	150.6	13.3	110%	-	-	201.8	103%
Overseas sales		13.5	27.2	41.3	57.8	17.9	133%	35.1	129%	58.1	16.7	141%	-	-	74.1	128%
America	3.4	7.2	10.3	13.4	4.8	140%	8.4	117%	11.6	1.3	113%	-	-	13.8	103%
Europe	6.8	13.2	20.6	30.0	8.9	130%	18.1	137%	33.4	12.8	162%	-	-	42.4	141%
Asia and others	3.1	6.6	10.4	14.3	4.1	130%	8.5	128%	13.0	2.6	125%	-	-	17.8	124%
Operating income			9.4	14.1	20.6	29.0	7.7	83%	18.5	131%	34.9	14.3	170%	-	-	38.5	132%

ProStrakan (GBP)

Millions of GBP, rounded down

FY 2014 results

FY 2015 results

FY 2015

forecasts

Jan - Mar

Jan - Jun

Jan - Sep

Jan - Dec

Jan - Mar

Jan - Jun

Jan - Sep

Change Amount

Jan - Dec

Net sales

38.4

78.0

125.3

181.4

53.7

140%

108.7

139%

163.7

38.3

131%

220.1

121%

Cancer pain

Abstral

12.1

25.7

40.6

55.8

12.9

107%

27.5

107%

42.6

1.9

105%

56.2

101%

Cancer pain

PecFent

2.4

7.5

5.4

10.9

16.9

14.5

687%

24.3

323%

Chemotherapy-induced nausea and vomiting drug

Sancuso

2.7

6.3

10.0

14.0

3.9

140%

8.2

131%

12.7

2.7

128%

18.2

130%

Replacement therapy with testosterone for male hypogonadism

Tostran

2.7

5.9

9.2

13.0

5.8

216%

9.2

154%

12.2

3.0

133%

16.1

123%

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

(0.4)

95%

10.6

92%

Osteoporosis drug

Adcal-D3

7.1

13.9

21.3

29.3

6.7

94%

13.2

95%

20.3

(0.9)

95%

27.8

95%

Others

7.9

15.3

27.9

44.4

15.7

199%

32.5

212%

48.8

20.9

175%

64.8

146%

Product net sales (subtotal)

35.4

72.9

120.0

175.9

53.4

151%

107.2

147%

161.8

41.7

135%

218.3

124%

Technology Out-Licensing and others

2.9

5.0

5.2

5.4

0.2

1.4

29%

1.9

(3.3)

37%

1.8

33%

Gross profit

28.8

58.7

91.0

129.1

38.9

135%

81.4

139%

121.2

30.2

133%

161.7

125%

Selling, general and administrative expenses *1

17.8

35.2

55.0

80.0

22.5

126%

45.1

128%

66.7

11.6

121%

91.0

114%

EBIDTA *2

10.9

23.5

35.9

49.1

16.4

150%

36.2

154%

54.5

18.5

152%

70.7

144%

Amortization of goodwill and sales rights

9.9

19.9

33.2

49.2

15.4

155%

30.6

154%

46.4

13.1

139%

61.9

126%

Operating income

1.0

3.5

2.6

(0.1)

1.0

105%

5.6

156%

8.1

5.4

304%

8.7

*1 Amortization of goodwill and sales rights is not included in Selling, general and administrative expenses.

Amortization of goodwill and sales rights = Depreciation + amortization of goodwill

*2 EBITDA ＝Operating income + depreciation + amortization of goodwill

*3 Archimedes was aquired 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 - September 2015 is as follows:

UK	Europe (excluding UK)	USA	Other
32.4%	50.1%	15.9%	1.6%

Kyowa Medex Co., Ltd.

Billions of yen, rounded down

FY 2014 results				FY 2015 results									FY 2015 forecasts
Jan - Mar	Jan - Jun	Jan - Sep	Jan - Dec	Jan - Mar	%	Jan - Jun	%	Jan - Sep	Change Amount	%	Jan - Dec	%	Jan - Dec	%
Net sales			2.6	5.7	8.4	11.7	2.5	95%	5.5	98%	8.5	0.1	101%	-	-	11.9	101%
Japan sales		2.1	4.6	7.0	9.7	2.1	99%	4.6	100%	7.0	0.0	100%	-	-	10.0	103%
Biochemical Diagnostic Reagent	0.8	1.9	2.9	4.0	0.8	99%	1.8	99%	2.9	(0.0)	99%	-	-	4.0	101%
Immunological Diagnostic Reagent	1.0	2.3	3.4	4.7	0.9	94%	2.2	98%	3.4	(0.0)	100%	-	-	4.8	102%
Other	0.2	0.4	0.6	0.8	0.2	115%	0.4	110%	0.6	0.0	112%	-	-	1.0	118%
Exports		0.5	1.0	1.4	2.0	0.4	80%	0.9	91%	1.5	0.0	106%	-	-	1.8	93%
Operating income			0.0	0.3	0.4	0.7	0.0	83%	0.3	93%	0.4	0.0	103%	-	-	0.9	126%

V. Segment information and Main Subsidiaries Operating Profit or Loss

Bio-Chemicals segment

Bio-Chemicals segment total

Billions of yen, rounded down

FY 2014 results				FY 2015 results									FY 2015 forecasts
Jan - Mar	Jan - Jun	Jan - Sep	Jan - Dec	Jan - Mar	%	Jan - Jun	%	Jan - Sep	Change Amount	%	Jan - Dec	%	Jan - Dec	%
Net sales			23.5	44.0	62.7	83.9	22.1	94%	45.0	102%	67.1	4.3	107%	-	-	88.0	105%
Japan sales		12.9	25.1	35.2	47.6	12.1	94%	24.1	96%	36.7	1.4	104%	-	-	48.5	102%
Overseas sales		10.6	18.8	27.4	36.3	10.0	94%	20.8	110%	30.3	2.8	110%	-	-	39.5	109%
America	2.0	4.1	6.2	8.2	2.5	124%	5.2	127%	7.9	1.7	128%	-	-	9.9	119%
Europe	4.1	8.0	12.0	15.6	4.3	103%	8.2	102%	12.0	0.0	101%	-	-	15.0	96%
Asia and others	4.4	6.6	9.2	12.4	3.1	71%	7.3	110%	10.2	1.0	111%	-	-	14.6	118%
Operating income			3.0	4.2	5.6	7.2	1.4	48%	3.9	95%	6.4	0.7	114%	-	-	8.5	117%

Kyowa Hakko Bio Co., Ltd.

Billions of yen, rounded down

FY 2014 results

FY 2015 results

FY 2015 forecasts

Jan - Mar

Jan - Jun

Jan - Sep

Jan - Dec

Jan - Mar

Jan - Jun

Jan - Sep

Change Amount

Jan - Dec

Net sales

17.3

31.5

44.5

58.0

14.1

82%

31.0

99%

45.8

1.2

103%

61.4

106%

Japan sales

9.9

19.1

27.1

35.7

8.7

89%

18.1

95%

27.1

(0.0)

100%

36.4

102%

Pharmaceutical and industrial

4.2

8.1

11.4

14.9

3.2

76%

6.9

85%

10.3

(1.0)

91%

13.9

94%

materials

Healthcare

2.6

5.4

8.2

11.0

2.5

96%

5.6

105%

8.7

0.5

107%

12.1

110%

Other

2.9

5.5

7.5

9.8

2.9

100%

5.5

100%

8.0

0.4

106%

10.3

106%

Exports

7.4

12.3

17.3

22.3

5.4

73%

12.9

104%

18.6

1.2

107%

25.0

112%

Operating income

2.7

3.6

4.7

5.6

1.3

48%

2.9

81%

4.4

(0.2)

94%

6.2

111%

DAIICHI FINE CHEMICAL CO., LTD.

Billions of yen, rounded down

FY 2014 results

FY 2015 results

FY 2015 forecasts

Jan - Mar

Jan - Jun

Jan - Sep

Jan - Dec

Jan - Mar

Jan - Jun

Jan - Sep

Change Amount

Jan - Dec

Net sales

3.5

6.9

9.4

13.3

3.5

100%

6.6

96%

10.4

1.0

111%

13.3

100%

Operating income

(0.0)

(0.1)

0.3

0.1

0.7

1.3

1.5

1.7

458%

Note: On October 1, 2015, DAIICHI FINE CHEMICAL CO., LTD. changed its company name (trade name) to 'Kyowa Pharma Chemical Co., Ltd.'

Ⅵ．R&D Pipeline

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

Approved in KR

Kirin-Amgen

Filed in TH

NDA in preparation in MY

Filed・Approved

antibody protein small molecule

As of Oct. 21, 2015

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

PhaseⅡ 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

Peripheral T-cell Lymphoma

Phase Ⅱ in EU

In-House

POTELLIGENT®

Adult T-cell Leukemia/Lymphoma

Phase Ⅱ

in US, EU and others

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

Jointly Developed with AstraZeneca/MedImmune in JP and KR POTELLIGENT®

Chronic Obstructive Pulmonary Disease(COPD)

Phase Ⅲ in JP

◎ASKP1240

Injection

Anti-CD40 Fully Human Antibody

Organ Transplant Rejection

Phase Ⅰin JP

In-House

Jointly Developed with Astellas

Human Antibody-Producing mouse

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 Ⅱ in US

In-House

Jointly Developed with Ultragenyx in US and EU

Human Antibody-Producing mouse

PhaseⅠ in JP and KR

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

PhaseⅢ in CN

Phase Ⅱ, Phase Ⅲ

Updated since Jul 24th, 2015 （Area, Stage, Filed, Approved, etc.）

◎ New Molecular Entity

Ⅵ．R&D Pipeline

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

◎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

◎KHK2804/ CEP-37250

Injection

Anti-Tumor Specific Glycoprotein Humanized Antibody

Cancer

Phase Ⅰ in US

Licensed from Teva

Jointly Developed with Teva

POTELLIGENT®

KW-0761

Mogamulizumab Injection

Anti-CCR4 Humanized Antibody

Solid Tumor

Phase Ⅰ in US

In-House

Combination with MEDI4736/Tremelimumab (Jointly Developed with AstraZeneca) POTELLIGENT®

Combination with Docetaxel POTELLIGENT®

Combination with PF-05082566 (Jointly Developed with Pfizer) POTELLIGENT®

PhaseⅠ in JP

Combination with Nivolumab (Jointly Developed with

Ono Pharmaceutical

Bristol-Myers Squibb)

POTELLIGENT®

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

ＰhⅠ

antibody protein small molecule

As of Oct. 21, 2015

Updated since Jul 24th, 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

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

Approved in KR

Kirin-Amgen

Updated since Jul 24th, 2015 （Area, Stage, Filed, Approved, etc.） Filed・Approved

Area

Code Name Generic Name Formulation

Mechanism of Action

Indication

Stage

In-House or Licensed

Remarks

Others

AMG531

Romiplostim Injection

Thrombopoietin Receptor Agonist

Idiopathic (Immune) Thrombocytopenic Purpura

PhaseⅢ in CN

Kirin-Amgen

ＰhⅡ～ＰhⅢ

Code Name

Generic Name

Stage

Remarks

FKB327

Adalimumab

（fully human anti-TNF-α monoclonal antibody）

Phase Ⅲ

in US and others

PhaseⅢ As of October 21st 2015

Code Name

Generic Name

Stage

Remarks

FKB238

Bevacizumab

（humanized anti-VEGF monoclonal antibody）

Phase Ⅰ in UK

PhaseⅠ

distributed by

Market Closed - Japan Exchange Other stock markets 02:00:00 2024-04-26 am EDT			5-day change	1st Jan Change
2,630 ^JPY	+0.23%		-0.19%	+10.97%

Apr. 08	U.S. FDA declines to approve Supernus' drug-device combination for Parkinson's disease	RE
Apr. 03	Kyowa Kirin Buys Back 4 Billion Yen Worth of Shares in March	MT

U.S. FDA declines to approve Supernus' drug-device combination for Parkinson's disease	Apr. 08	RE
Kyowa Kirin Buys Back 4 Billion Yen Worth of Shares in March	Apr. 03	MT
Tranche Update on Kyowa Kirin Co., Ltd.'s Equity Buyback Plan announced on February 7, 2024.	Apr. 02	CI
Japanese Shares Slip into Red Amid Profit-Taking; Tokyo Inflation Eyed	Mar. 25	MT
Kyowa Kirin to Allocate Over 84,000 Treasury Shares as Director, Officer Compensation	Mar. 25	MT
Kyowa Kirin's gene therapy most expensive US drug with $4.3 million price tag	Mar. 20	RE
US approves first gene therapy for children with rare genetic disease	Mar. 18	RE
US approves first gene therapy for rare genetic disease	Mar. 18	RE
Kyowa Kirin Co., Ltd. to Present Phase 2B Post-Hoc Analysis and Symposium At the American Academy of Dermatology Annual Meeting 2024	Mar. 08	CI
Kyowa Kirin Buys Back Nearly 3 Billion Yen of Shares	Mar. 05	MT
China Deflation, Bank of Japan Roil Asian Stock Markets	Feb. 08	MT
Japan's Nikkei closes at 34-year peak on dovish BOJ; tech shares soar	Feb. 08	RE
Japan's Nikkei leaps to 2-week high on tech stocks, yen boost	Feb. 07	RE
BridgeBio Pharma Unit to Grant Kyowa Kirin License for Infigratinib in Japan	Feb. 07	MT
Kyowa Kirin's Profit Up 52% in Fiscal 2023	Feb. 07	MT
Kyowa Kirin Co., Ltd. Provides Dividend Guidance for the Year Ending December 31, 2024	Feb. 07	CI
Kyowa Kirin Co., Ltd. Declares Dividend for the Fiscal Year Ended December 31, 2023, Payable on March 25, 2024; Provides Dividend Guidance for the Second Quarter of 2024	Feb. 07	CI
Kyowa Kirin Co., Ltd. Provides Consolidated Earnings Guidance for the Full Year Ending December 31, 2024	Feb. 07	CI
Kyowa Kirin Co., Ltd. announces an Equity Buyback for 17,000,000 shares, representing 3.16% for KRW 40,000 million.	Feb. 07	CI
Kyowa Hakko Kirin Co., Ltd. authorizes a Buyback Plan.	Feb. 06	CI
Kyowa Kirin Announces First Patient Enrolled in the Phase 2 Clinical Trial Evaluating Tivozanib Eye Drops in Patients with Diabetic Macular Edema	Feb. 06	CI
Japanese Shares Skid as Inflation Slows Faster-than-Expected in January	Jan. 26	MT
Kyowa Kirin Acquires All Outstanding Shares of Orchard Therapeutics	Jan. 25	MT
Orchard Therapeutics Completes Sale to Japan's Kyowa Kirin	Jan. 24	MT
Kyowa Kirin Co., Ltd. completed the acquisition of Orchard Therapeutics plc from RA Capital Management, L.P., Deep Track Capital, LP, Zentree Investment Management Pte. Ltd. and others.	Jan. 23	CI

	1st Jan change	Capi.
KYOWA KIRIN CO. LTD.	+10.97%	9.03B
MERCK KGAA	+5.31%	69.91B
SK BIOPHARMACEUTICALS CO., LTD.	-16.83%	4.75B
SHENYANG XINGQI PHARMACEUTICAL CO.,LTD.	+43.48%	4.31B
YUHAN CORPORATION	+3.20%	3.88B
INDIVIOR PLC	+18.82%	2.37B
BETTA PHARMACEUTICALS CO., LTD.	-21.36%	2.26B
CHANGCHUN BCHT BIOTECHNOLOGY CO.	-29.67%	2.2B
SHANGHAI SHYNDEC PHARMACEUTICAL CO., LTD.	+8.38%	1.98B
VELOXIS PHARMACEUTICALS A/S	-0.50%	1.64B

Kyowa Kirin Co. Ltd.

Equities

4151

JP3256000005

Pharmaceuticals

Kyowa Hakko Kirin : Appendix to the Consolidated Financial Summary Fiscal 2015 Third Quarter(255KB)

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Sector Specialty & Advanced Pharmaceuticals