KYOWA KIRIN CO. LTD. Results Presentation Fiscal 2015
(January 1, 2015 - December 31, 2015)
Kyowa Hakko Kirin Co., Ltd.
FY 2015 Highlights
Nobuo Hanai, Ph. D. President and CEO
Financial review 2016 Forecasts
Kazuyoshi Tachibana, Managing Executive Officer
R & D review Topics
Nobuo Hanai, Ph. D. President and CEO
This document contains certain forward-looking statements relating to such items as the company's (including its domestic and overseas subsidiaries) forecasts, targets and plans. These forward-looking statements are based upon information available to the company at the present time and upon reasonable assumptions made by the company in making its forecasts, but actual results in practice may differ substantially due to uncertain factors.
These uncertain factors include, but are not limited to, potential risks of the business activities of the pharmaceutical industry in Japan and overseas, intellectual property risks, risk of side effects, legal regulation risks, product defect risks, risks of changes to prices for raw materials, risks of changes to market prices, as well as risks of changes to foreign exchange rates and financial markets.
This document contains information on pharmaceutical products (including products under development), but its contents should not be construed as promotion, advertising or as a medical recommendation.
In FY2015, the final year of the medium-term business plan, consolidated net income increased ¥13.8 billion YoY due to increased sales and profits in both the Pharmaceuticals business
and the Bio-Chemicals business
In the Pharmaceuticals business, new products G-Lasta®, Dovobet®, Onglyza®, and NOURIAST® progressed steadily, and Japan sales increased
¥15.9 billion YoY
In the Pharmaceuticals business, overseas pharmaceutical sales increased
¥12.7 billion YoY due to increased sales resulting from the acquisition of Archimedes and currency effects
In the Bio-Chemicals business, sales increased ¥4.9 billion YoY due to growth in the Japanese healthcare market and sales of amino acids for the
U.S. and Europe, and currency effects
Net income increased ¥13.8billion YoY due to increases in operating income and gains on sales of investment securities
© 2015 Kyowa Hakko Kirin Co., Ltd. 4
Financial review
© 2015 Kyowa Hakko Kirin Co., Ltd. 5
Summary of 2015 results (consolidated)Consolidated sales and profits increased YoY due to factors such as growth of domestic pharmaceutical products and despite higher expenses such as R&D costs in the Pharmaceuticals business
（Unit: ¥bn） | FY2014 results | FY2015 results | Change | FY2015 forecast |
Net sales | 333.4 | 364.3 | 30.8 (+9%) | 360.0 |
Operating Income Operating margin | 36.1 10.8% | 43.7 12.0% | 7.5 (+21%) | 47.0 |
Ordinary income | 29.5 | 39.2 | 9.6 (+33%) | 41.0 |
Net income | 15.8 | 29.7 | 13.8 (+87%) | 26.0 |
(Profits stated after amortization of goodwill. Figures rounded down)
Ordinary income increased due to growth in operating income and decrease in losses in affiliates accounted for by the equity method
Net income increased due to growth in ordinary income and other factors, such as gain on sale of investment
securities
© 2015 Kyowa Hakko Kirin Co., Ltd. 6
Summary of FY2015 consolidated results: Analysis of YoY profit changes FY2015 net income: Analysis of YoY changes(¥bn)
40
35
30
+13.8
Pharmaceuticals -¥11.1bn
Kyowa Hakko Kirin (parent) -¥3.6bn (Increase in R&D costs, etc.)
ProStrakan -¥6.6bn (Archimedes, currency effects, etc.)
Bio-Chemicals -¥0.7bn
Currency effects of overseas subsidiaries, etc.
25 19.4
+194
▲118
+44
-11.8 4.4
+21
2.0
▲1
-0.2
20 Losses of equity accounted
affiliates +¥2.3bn
15
Gain on sale of investment securities
+¥6.5bn
Gain on sale of fixed assets +¥0.9bn Impairment loss -¥4.4bn
299
29.7
158
10
15.8
5
Pharmaceuticals +¥18.2bn
Kyowa Hakko Kirin (parent) +¥8.5bn (growth of new products, etc.)
ProStrakan +¥7.8bn (Archimedes, currency effects, etc.)
Bio-Chemicals +¥1.6bn
Kyowa Pharma Chemical +¥1.3bn
FY2014
FY2014
results
Gross profits
Gross profits
SG&A No expenses
SG&A
expenses
n-operating profit/loss
Non-operating profit/loss
Extraordinary income/loss
Taxes FY2015 results
In the Pharmaceuticals business, sales and profits increased due to growth of domestic pharmaceutical products, especially new products, and other factors
In the Bio-Chemicals business, sales and profits increased due to growth in areas such as amino acids for overseas supplements and infusion use, as well as ongoing yen weakness
（Unit：¥bn） | FY2014 results | FY2015 results | Change | |
Pharmaceuticals business | Net sales | 253.0 | 279.2 | 26.2 (+10%) |
Operating income Operating margin | 29.0 11.5% | 36.2 13.0% | 7.1 (+25%) | |
Bio-Chemicals business | Net sales | 83.9 | 88.8 | 4.9 (+6%) |
Operating income Operating margin | 7.2 8.7% | 8.1 9.1% | 0.8 (+12%) |
(Profits stated after amortization of goodwill. Figures rounded down)
Net sales Operating income
FY2014 results
Domestic sales
(parent)
Technology licensing
(parent)
Overseas sales (including ProStrakan)
253.0
-2.2
+15.9
+12.7
FY2014 results
Gross profits SG&A (excl. R&D
expenses）
R&D expenses
29.0
+18.2
-6.6
-4.4
Others / Eliminations
FY2015 results
-0.2
Currency
FY2015 results
Currency ffects +0.9
Currency
36.2
279.2
effects +5.1 e
effects -0
(¥bn)
0 225 250 275 300
(¥bn)
0 10 20 30 40 50
Net sales (+¥26.2bn):
Domestic pharmaceutical products (+¥15.9bn):
Products (shipments): New products G-Lasta® +¥9.9bn, Dovobet® +¥3.5bn, Onglyza® +¥3.5bn, NOURIAST® +¥2.5bn, ALLELOCK® -¥1.5bn, CONIEL®
-¥2.0bn, GRAN® -¥3.3bn.
NESP® (+¥2.1bn): Sales volume and net sales increased YoY due to additional indication for anemia with myelodysplastic syndrome and other factors. Our share was maintained.
Technology licensing, etc. (-¥2.2bn): Currency effects +¥0.7bn.
Decrease in royalties associated with out-licensing contract
Overseas sales (+¥12.7bn): Currency effects +¥4.1bn.
ProStrakan (+¥9.6bn): Effects of consolidation of Archimedes, etc.
Operating income (+¥7.1bn)
Gross profits (+¥18.2bn): Currency effects +¥4.4bn.
Domestic sales increased due to growth in new products (in particular new products such as G-Lasta®).
ProStrakan growth contributed to further growth in profits.
SG&A (-¥6.6bn): Currency effects -¥2.4bn.
Effects of consolidation of Archimedes, etc.
R&D expenses (-¥4.4bn): Currency effects -¥1.6bn.
Launch of clinical trials in Japan for late-stage development products.
Increase in overseas R&D expenses and other factors.
FY2015
results
57.5
18.2
22.1
12.8
10.3
5.3
11.9
Sales increased YoY due to market penetration of new products and growth of key products such as NESP® , and despite the effects of the drug price revision in the previous year and the market penetration of generics
Product name, other information | FY2014 results | Change | Reason for change | FY2015 forecast |
NESP® | 55.3 | 2.1 (+4%) | (+) Effect of additional indication for MDS※ (-) Drug price revisions in the previous year | 56.9 |
REGPARA® | 16.3 | 1.8 (+11%) | (+)Steady growth in the market | 17.7 |
ALLELOCK® | 23.6 | -1.5 (-7%) | (+) Increase in airborne pollen count level (-) Drug price revisions in the previous year, market penetration of generics | 20.5 |
Patanol® | 11.8 | 0.9 (8%) | (+) Increase in airborne pollen level and other factors | 11.9 |
G-Lasta® | 0.3 | 9.9 (N/A) | (+) Steady penetration of the market following launch end of November, 2014 | 8.9 |
NOURIAST® | 2.8 | 2.5 (+91%) | (+) Steady penetration of the market | 5.5 |
Technology out-licensing | 13.9 | -2.0 (-15%) | (-) Decrease in royalties and other factors | 12.8 |
* Myelodysplastic Syndrome (Unit: ¥bn, figures rounded down)
Bio-Chemicals business: FY2015: Analysis of YoY profit changesNet sales Operating income
FY2014 results Overseas sales
Pharmaceutical and health food materials
Consumer products Kyowa Pharma Chemical
Other/ Eliminations FY2015 results
83.9
88.8
+3.6
-0.5
+0.6
+0.3
+0.9
Currency effects +2.5
FY2014 results
Gross profits SG&A (excl. R&D
expenses)
R&D expenses
FY2015 results
7.2
+1.6
-1.2
+0.4
Currency effects +1.4
8.1
(¥bn)
0 75 80 85 90
(¥bn)
0 4 6 8 10
Net sales (+¥4.9 bn)
Overseas sales (+¥3.6bn): Currency effects +¥2.3 bn
U.S. (+¥1.9bn): Currency effects (+¥1.3bn), sales increased due to growth in health- food-use amino acids, etc.
Europe (-¥0.1bn): Currency effects (-¥0.6bn), sales declined due to weakened Euro and the effects of the transfer of cosmetics business, and despite a recovery in demand for infusion-use amino acids from some customers.
Asia and others (+¥1.8bn): Currency effects (+¥1.6bn), sales increased due to a recovery from inventory adjustments by some customers in the previous year and ongoing yen weakness.
Pharmaceuticals and health food materials(-¥0.5bn): Sales declined as growth in health-food-use raw materials failed to compensate for the year-on-year decline resulting from concentrated shipments of some generic drug APIs in the previous year.
Consumer products (+¥0.6bn): Mail order sales were strong and increased from the previous year
Kyowa Pharma Chemical (+¥0.3bn): Due to difference in accounting period in which sales of pharmaceutical intermediates were recorded, etc.)
Operating income (+¥0.8bn)
Gross profit (+¥1.6bn): Currency effects +¥1.8bn
Positive factors were currency effects, growth of mail order sales, and cost improvements in some of Kyowa Pharma Chemical's products, etc.
Negative factors were an increase in costs related to planned reorganization of production facilities at Yamaguchi Production Center and establishment of overseas manufacturing facilities.
SG&A (-¥1.2bn): Currency effects -¥0.4bn
Increase in sales promotion costs for mail order sales, etc.
On October 1, 2015 the company name (trade name) of Daiichi Fine Chemical Co., Ltd. was changed to Kyowa Pharma Chemical Co., Ltd.
© 2015 Kyowa Hakko Kirin Co., Ltd. 11
2016 Forecasts
FY2016 consolidated forecastsWe forecast a decrease in sales due to the effect of the drug price revision and market penetration of generics in Japan, and
a decrease in profits as we continue investment in late-stage developments
(Unit: ¥bn)
FY2015 results
FY2016 forecasts
Change
(%)
Net sales
364.3
351.0
-13.3
(-4%)
Operating income
Operating margin
43.7
[12.0%]
30.0
[8.5%]
-13.7
(-31%)
Ordinary income
39.2
25.0
-14.2
(-37%)
Net income
29.7
16.0
-13.7
(-46%)
(Profits stated after amortization of goodwill. Figures rounded down)
Summary of FY2016 consolidated forecasts: Analysis of YoY profit changes(¥bn)
40
35
FY2016 net income forecast: Analysis of YoY changesPharmaceuticals -¥10.0bn
Kyowa Hakko Kirin (parent) -¥15.1bn (drug price revision, etc.)
▲138
Bio-Chemicals +¥0.1bn
30
25
20
299
15 29.7
10
5
-9.2
Extraordinary Income -¥7.1bn
▲92
(Decrease in gain on sales of securities, etc.)
Extraordinary Losses +¥5.9bn
(Decrease in impairment loss, etc.)
▲46
▲4
▲11
+14
-4.6 -0.4 -1.1 1.6
Pharmaceuticals -¥3.1bn
Increase in R&D expenses, preparation for overseas launches, etc.
Bio-Chemicals -¥1.3bn
-13.7
160
16.0
前年実績
FY2015
results
売上総利
Gross profits
益 販管費
SG&A
expenses
営業外損益
特別損益 税
Non- operating s
Non-operating profit/loss
金費用
Extraordinary income/loss
1/29公表値
Taxes FY2016 forecast
(Unit: ¥bn)
FY2015
results
FY2016
forecasts
Change
Net sales
279.2
268.0
-11.2
(-4%)
Operating income
Operating margin
36.2
[13.0％]
23.0
[8.6%]
-13.2
(-36%)
Operating income YoY change
FY2015 results Gross profits
SG&A
(excl. R&D expenses)
R&D expenses
FY2016 forecasts
36.2
-4.2
-10.0
+1.1
Currency effects -0.2
(+)
Decrease in in-licensing expenses
(-)
Negative effects of the drug price revision
Increase in R&D expenses
Decrease in tech out-licensing incomes
(¥bn)
23.0
0 10 20 30 40
(Unit: ¥bn)
FY2015
results
FY2016
forecasts
Change
Net sales
88.8
87.0
-1.8
(-2%)
Operating income
Operating margin
8.1
[ 9.1%]
7.0
[ 8.0%]
-1.1
(-14%)
Operating income YoY change
FY2015 results Gross profits
SG&A
(excl. R&D expenses)
8.1
-1.0
+0.1
(-)
Increase in sales promotion costs for mail order sales, etc.
Increase in expenses related to the
R&D expenses -0.3
establishment of new manufacturing processes for high-value-added amino
FY2016 forecasts
(¥bn)
7.0
Currency effects -0
0 10 20 30 40
acids, etc.
Maximize corporate value = Maximize shareholder value
Shareholder returns policy
Dividend payout ratio
Targeting a stable dividend payout ratio of 40% of profits before amortization of goodwill
Acquisition of treasury stock Implement flexibly in response to market environment and finances
Planned dividends for period
Based on the company's shareholder returns policy, the company expects to pay a year-end dividend of ¥12.50 per share
(Including an interim dividend of ¥12.50 per share, the total dividend will be ¥25 per share)
Dividends/payout ratio
Note: "Before 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).
© 2015 Kyowa Hakko Kirin Co., Ltd. 17
R & D review
Domestic:
☑ Initiation of Phase 2 trials of RTA 402 targeting chronic kidney disease with type-2 diabetes (March)
☑ Initiation of Phase 1 trials of Nivolumab (ONO PHARMACEUTICAL/Bristol- Myers Squibb) in combination with KW-0761 (brand name in Japan: POTELIGEO®) targeting solid tumors (July)
☑ Application for marketing authorization of fully human anti-IL-17 receptor antibody KHK4827(July)
☑ Approval for marketing authorization of recombinant human antithrombin drug KW-3357 (brand name in Japan: ACOALAN®) (July) and sale (September)
☑ Initiation of Phase 3 trials of KHK4563 targeting COPD (July)
☑ Initiation of Phase 3 trials of KHK7580 targeting secondary hyperparathyroidism (November)
Overseas:
☑ Application for marketing authorization of KRN321 (brand name in Japan: NESP®) (February, China)
☑ Initiation of Phase 1 trials of PF-05082566 (Pfizer) in combination with KW- 0761 targeting solid tumors (June, U.S.)
☑ Agreement to collaborate on development of Phase 1/2 trials of Nivolumab (Bristol-Myers Squibb) in combination with KW-0761 targeting solid tumors (July, U.S.)
☑ Initiation of Phase 3 trials of AMG531 (brand name in Japan: Romiplate®) targeting ITP (September, China)
☑ Initiation of Phase 3 trials of KRN23 targeting adult XLH (December, North America, Europe, Asia)
Development stage Indication Country/ (Scheduled trial completion date) Estimated region Phase 2 Phase 3 Application enrollment | ||||||
ATL | Relapsed/ refractory | U.S., Europe, others2 | (2015/12) | 704 | ||
CTCL | Relapsed/ refractory | U.S., Europe, Japan, others2 | (2017/2) | 3175 | ||
Annual incidence per disease U.S. CTCL: approx. 1,5003 patients
1Launched in Japan (brand name POTELIGEO®)
2CCR4 not included in selection criteria
3SEER Data (2001-2007)
ClinialTrials.gov identifier:
4NCT01626664; 5NCT01728805
Development stage Indication Country/ Concomitant (Scheduled trial completion date) Partner Estimated region Drug Phase 1 enrollment | ||||||
Solid tumor | U.S. | Durvalumab or Tremelimumab | (2016/6) | AstraZeneca | 1081 | |
U.S. | PF-05082566 | (2018/3) | Pfizer | 702 | ||
Japan | Nivolumab | (2017/10) | ONO PHARMACEUTICAL Bristol-Myers Squibb | 1083 | ||
U.S. | Nivolumab | In preparation | Bristol-Myers Squibb | - | ||
U.S. | Docetaxel | (2016/2) | - | 274 | ||
ClinicalTrials.gov identifier:
1 NCT02301130; 2 NCT02444793; 3 NCT02476123; 4 NCT02358473
Development stage Indication Country/ (Scheduled trial completion date) Estimated region Phase 2 Phase 3 Application Approval enrollment | ||||||
Parkinson's disease | Japan | 2013/31 | ||||
North America, Europe, Others | (2016/4) | 6094 | ||||
Patient numbers Japan: approx. 140,0002
U.S.: approx. 570,0003
1Launched in Japan (brand name: NOURIAST®)
2 Ministry of Health, Labour and Welfare: 2011 Patient survey (illness classification)
3Study by Decision Resources ClinialTrials.gov identifier:
4NCT01968031
Development stage Indication Country/ (Scheduled trial completion date) Partner Estimated region Phase 1 Phase 2 Phase 3 enrollment | |||||||
XLH | Pediatric | U.S., Europe | (2017/3) | Ultragenyx Pharmaceutical (U.S., Europe) | 504 | ||
Adult J | U.S. | (2016/9) | 255 | ||||
NA., Europe Japan, Korea | (2017/3) | 1206 | |||||
NA., Europe apan, Korea | (2017/1) | 157 | |||||
Japan, Korea | (2015/12) | 158 | |||||
TIO/ENS | U.S. | (2016/9) | 69 | ||||
Estimated no. of patients
XLH
Japan: approx. 5,0001 adult patients approx. 1,0001 pediatric patients
U.S.: approx.12,0001 adult patients approx. 3,0001 pediatric cases
TIO / ENS
Japan: approx. 302 patients
U.S.: approx.500 - 1,0003 patients
1Estimate based on reported prevalence of 1 in 20,000 people
22010 Ministry of Health, Labour and Welfare Epidemiological Research on abnormalities in Hormone Receptor Mechanisms
3Survey by Ultragenyx Pharmaceutical
ClinialTrials.gov identifier:
4NCT02163577; 5NCT02312687; 6NCT02526160; 7NCT02537431 8NCT02181764; 9NCT02304367
© 2015 Kyowa Hakko Kirin Co., Ltd. 24
Study of pediatric patients with XLH
Phase 2 study ( Europe, U.S.): 36 patients* received KRN23 and in the 40- week interim results effectiveness and safety confirmed as follows:
Blood phosphorous improved to normal level, urine excretion of phosphorous improved, concentration in blood of 1,25(OH) 2D3 improved
Improvement in rickets imaging findings (RSS System, RGl-C)
Improvement in motor functions and QOL (6 minutes walking test, Patient report outcome)
Main side-effect was injection site reaction, no cessation of treatment due to fatalities or adverse events was reported
Phase 3 study (Europe, U.S., Japan, Korea) currently under review
Study of adult patients with XLH
Phase 3 study underway (Europe, U.S., Japan, Korea)
Placebo-controlled randomized double-blind comparative study
Unblinded single-arm bone biopsy study
35 of the 36 patients had received standard therapy for an average of 9 years before the trial.
© 2015 Kyowa Hakko Kirin Co., Ltd.
Topics
KHK has entered into a licensing agreement with Sandoz for the sale of biosimilar rituximab in Japan to strengthen efforts in hematologic cancers,
a priority disease area
Rituximab
Chimeric anti-CD20 monoclonal antibody
Sandoz is developing rituximab globally, its main indication is for CD20-positive non-Hodgkin lymphoma
Significance of licensing agreement:
Strengthens product lineup in hematologic cancers, a priority disease area within oncology, one of our major categories
Meets diverse needs of healthcare providers and patients
Details of agreement:
Upfront contractual payment on agreement, milestone payments contingent upon success in development stages, royalties paid after sale
Sandoz will file for marketing authorization
KHK will conduct sales and marketing activities
ATL Adult T-cell Leukemia/Lymphoma CCR4 Chemokine ( C-C motif ) Receptor 4 COPD Chronic Obstructive Pulmonary Disease CTCL Cutaneous T-Cell Lymphoma
ENS Epidermal Nevus Syndrome
ITP Idiopathic Thrombocytopenic Purpura
TIO Tumor Induced Osteomalacia XLH X-linked Hypophosphatemia
The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.
If you have any inquiries regarding this presentation, please call: Corporate Communications Department, Kyowa Hakko Kirin Co., Ltd.
Tel: +81-3-3282-0009
APPENDIX
In the Pharmaceuticals business, profits decreased due to increased SG&A as a result of product licensing and other factors
In the Bio-Chemicals business, profits decreased due to high costs associated with the establishment of manufacturing facilities overseas and other factors
（Unit：¥bn）
FY2015
forecasts
FY2015
results
Change
Pharmaceuticals business
Net sales
276.0
279.2
3.2
(+1%)
Operating income
Operating margin
38.5
[13.9%]
36.2
[13.0%]
-2.3
(-6%)
Bio-Chemicals business
Net sales
88.0
88.8
0.8
(+1%)
Operating income Operating margin
8.5
[9.7%]
8.1
[ 9.1%]
-0.3
(-4%)
(Profits stated after amortization of goodwill. Figures rounded down)
(¥bn)
2015 Net income: comparison to forecasts26.0
40
35
3.7
30
Pharmaceuticals -¥3.2bn
Kyowa Hakko Kirin (parent) -¥2.0bn (upfront payment for product licensing, etc.) ProStrakan -¥1.4bn (currency effects, etc.)
+14
▲31
1.4
+41
4.1
Effects of accounting for income tax, etc.
+16
1.3
25
20
260
15.8
15
26.0
10
[値]
-0.1
-3.1
Losses of equity accounted affiliates
+¥0.7bn
Gain on sales of investment securities
+¥3.9bn
Gain on sales of non-current assets
+¥1.0bn
Impairment loss -¥0.5bn
299
29.7
5
FY2014
FY2015
forecasts
Gross profits
SG&A No expenses
SG&A
expenses
n-operating profit/loss
Non-operating profit/loss
Extraordinary income/loss
Taxes FY2015 results
FY2016 forecasts: Analysis of YoY changesNet sales Operating income
FY2015 results
Domestic sales
(parent)
Technology licensing
(parent)
Overseas sales (including ProStrakan)
Others / Eliminations FY2016 forecasts
279.2
-10.4
-4.4
268.0
+1.7
+1.9
Currency effects -0.4
FY2015 results Gross profits
SG&A (excl. R&D
expenses）
R&D expenses FY2016 forecasts
36.2
-4.2
Currency effects +0.9
23.0
-10.0
+1.1
Currency effects -0.2
(¥bn)
0 225 250 275 300
(¥bn)
0 10 20 30 40
Net sales (-¥11.2bn)
Domestic pharmaceutical products (-¥10.4bn):
Products (shipments): New products G-Lasta® +¥4.8bn, Onglyza® +¥2.2bn, NOURIAST® +¥1.6bn, Dovobet® +¥0.7bn, REGPARA® +¥0.8bn, Fentos®
+¥0.4bn, GRAN® -¥2.6bn, CONIEL® -¥2.6bn, NESP® -¥2.8bn, ALLELOCK® -
¥3.9bn
Technology licensing, etc. (-¥4.4bn): Currency effects -¥0.0bn
Upfront payment of US$45 million last year associated with option agreement for exclusive sales of KHK4563 in Japan, etc.
Overseas sales (+¥1.7bn): Currency effects -¥0.3bn
ProStrakan (+¥1.2bn): growth of Abstral ®, Pecfent ®, Sancuso ®, etc.
Others
Increase in technology out-licensing milestone payment, etc.
Operating income (-¥13.2bn)
Gross profits (-¥10.0bn): Currency effects -¥0.5bn
Effects of drug price revision and upfront payment of US$45 million last year associated with option agreement for exclusive sales of KHK4563 in Japan, etc.
SG&A (+¥1.1bn): Currency effects -¥0.0bn
Factors in cost increase: Expenses incurred in preparation for launch of development products at ProStrakan, etc.
Factors in cost reduction: Upfront payment for product in-licensing in previous year, etc.
R&D expenses (-¥4.2bn): Currency effects +¥0.2bn
Increase in research expenses at pre-clinical stage, etc.
Increase in ProStrakan's development expenses in Europe and the U.S.
Net sales Operating income
FY2015 results
Overseas sales
Pharmaceutical and health food materials
Consumer Products
88.8
-0.9
+0.7
+0.5
FY2015 results
Gross profits SG&A (excl. R&D
expenses)
8.1
-1.0
+0.1
Kyowa Pharma Chemical
Other/ Eliminations FY2016 forecasts
-1.9
-0.2
87.0
Currency effects -0.2
R&D expenses
FY2016 forecasts
7.0
-0.3
Currency effects -0
(¥bn)
0 80 85 90
(¥bn) 02
4 6 8 10
Net sales (-¥1.8bn)
Overseas sales (+¥0.7bn): Currency effects -¥0.2bn
U.S. (+¥0.5bn): Currency effects (-¥0.1bn), sales increased due to growth in health-food-use and infusion amino acids
Europe (-¥0.1): Currency effects (+¥0.2bn), sales declined as growth in sales of pharmaceutical raw material-use amino acids failed to compensate for effects of transfer of cosmetics business.
Asia and others (+¥0.2bn): Currency effects (-¥0.2bn) growth in infusion-use amino acids, etc.
Pharmaceutical and health food materials(-¥0.9bn):
Concentrated shipments of some generic drug APIs in the previous year and end of sales of low-margin agency sales, etc.
Consumer products(+¥0.5bn): Growth in mail order sales
Kyowa Pharma Chemical (-¥1.9bn):
End of sales of low-margin agency sales, etc
Operating income (-¥1.1bn)
Gross profit (+¥0.1bn): Currency effects -¥0.1bn
SG&A (-¥1.0bn): Currency effects +¥0.0bn
Head office relocation expenses and increase in sales promotion costs for mail order sales, etc.
R&D expenses (-¥0.3bn):
Increase in expenses related to the establishment of new manufacturing processes for high added-value amino acids such as peptides and nucleic acid, etc.
On October 1, 2015 the company name (trade name) of Daiichi Fine Chemical Co., Ltd. was changed to Kyowa Pharma Chemical Co., Ltd.
© 2015 Kyowa Hakko Kirin Co., Ltd. 34
development updateDevelopment code | Reference bio medical product Generic name Brand name | Country/ region | Development stage | |||
Phase 1 | Phase 2 | Phase 3 | ||||
FKB327 | Adalimumab | HUMIRA | U.S., others | 1 | ||
FKB238 | Bevacizumab | Avastin | United Kingdom | 2 | ||
Not disclosed | Not disclosed | Not disclosed | Not disclosed | Determined target product | ||
Biosimilar pharmaceutical products are developed by FUJIFILM KYOWA KIRIN BIOLOGICS Co., Ltd.
ClinialTrials.gov identifier: 1NCT02260791
Development is currently conducted by Centus Biotherapeutics Limited.
BioWa launches business for the licensing of POTELLIGENT® technology alone, in addition to combined licensing of POTELLIGENT® technology and cell-line business
Combined licensing of POTELLIGENT® technology and cell- line business
By licensing the POTELLIGENT® technology and the POTELLIGENT® CHO DG44 cells and/or POTELLIGENT® CHOK1SV™ cells, customers have the right to commercialize POTELLIGENT® antibodies produced using these cells.
To date, BioWa has signed technology licensing agreements with 14 companies
POTELLIGENT® technology licensing business
By licensing POTELLIGENT® technology alone, customers have the right to create POTELLIGENT® cells utilizing the antibody- producing cells of their choice, and to commercialize POTELLIGENT® antibodies produced using these cells.
Greater freedom on choice in selection of antibody-producing cells
Name | Partner | Phase | Remarks | |||
I | II | III | ||||
Tivozanib | AVEO | Cancer (VEGF receptor inhibitor) (KRN951) | ||||
Benralizumab (MEDI-563) | AstraZeneca /MedImmune | Asthma | (Anti-IL-5R antibody) (KHK4563) POTELLIGENT® | |||
COPD | ||||||
KRN5500 | Midatech Pharma US | Peripheral neuropathy | ||||
RGI-2001 | REGiMMUNE | Phase1/2 | Immunosuppressive | |||
(as of January 22, 2016)
Average exchange rate | 2014 Results | 2015 Results | Change | FY2016 Forecast |
¥/$ | ¥105 | ¥121 | +¥16 | ¥119 |
¥/€ | ¥140 | ¥135 | -¥5 | ¥137 |
¥/£ | ¥173 | ¥185 | +¥12 | ¥187 |
Segment | Currency | Net sales | Operating income |
Pharmaceuticals business | $ | +¥1.1bn | -¥0.6bn |
€ | -¥0bn | +¥0bn | |
£ | +¥2.6bn | +¥0.1bn | |
Bio-Chemicals business | $ | +¥2.8bn | +¥1.8bn |
€ | -¥0.6bn | -¥0.3bn | |
£ | - | - |
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_02.pdf
