year ended march 31, 2016 -...
TRANSCRIPT
Year Ended March 31, 2016 Results of 2nd Quarter
Settlement of Accounts Supplementary Material (Apr.1 to Sep.30 2015)
Challenge Globally with Power of Creation November, 2015
Nichi-Iko Pharmaceutical Co., Ltd.
(Code No. 4541 1st section of TSE)
We, Nichi-Iko, make great efforts by ourselves to be sustainable for providing value-added, high quality generic products which meet various requirements from patients, pharmacists, doctors, wholesalers and pharmaceutical companies in the global market as one of the most respected, well established generic companies in the world.
Copyright 2015 Nichi-Iko Pharmaceutical Co., Ltd. P,1
Mission statement The 6th Medium-term Business Plan
(\million)FY2014 vs Sales FY2015 vs Sales
2Q (%) 2Q (%)
Sales 60,949 - 68,987 - 113.2%
COGS 38,469 63.1% 43,226 62.7% 112.4%
Gross Profit 22,491 36.9% 25,778 37.4% 114.6%
SG&A 18,081 29.7% 19,961 28.9% 110.4%
Labor Expense 2,821 4.6% 3,118 4.5% 110.5%
R&D Expense 2,226 3.7% 2,719 3.9% 122.1%
Sales Promotion Cost 7,617 12.5% 9,024 13.1% 118.5%
Others 5,417 8.9% 5,100 7.4% 94.1%
Operating Profit 4,410 7.2% 5,816 8.4% 131.9%Ordinary Profit 4,370 7.2% 5,136 7.4% 117.5%Quarterly Net ProfitAttributable to Parent
Capital Expense 2,744 7,794 284.0%
Depreciation 2,393 2,456 102.6%
YOY
3,007 4.9% 3,614 5.2% 120.2%
Copyright 2015 Nichi-Iko Pharmaceutical Co., Ltd. P,2
Consolidated Fiscal Year YOY
(\million)Forecast for vs Sales FY2015 vs Sales
FY2015 (%) 2Q (%)
Sales 137,200 - 68,987 - 50.3%
COGS 84,100 61.3% 43,226 62.7% 51.4%
Gross Profit 53,100 38.7% 25,778 37.4% 48.5%
SG&A 40,600 29.6% 19,961 28.9% 49.2%
Operating Profit 12,500 9.1% 5,816 8.4% 46.5%
Ordinary Profit 12,100 8.8% 5,136 7.4% 42.4%Quarterly Net ProfitAttributable to Parent
Capital Expense 11,200 7,794 69.6%
R&D Expense 5,900 2,719 46.1%
Depreciation 5,400 2,456 45.5%
vs Forecast
8,000 5.8% 3,614 5.2% 45.2%
Copyright 2015 Nichi-Iko Pharmaceutical Co., Ltd. P,3
Consolidated Fiscal Year VS Full Year Forecast
(\million)Forecast for vs Sales FY2015 vs SalesFY2015 2Q (%) 2Q (%)
Sales 65,300 - 68,987 - 105.6%
COGS - - 43,226 62.7% -
Gross Profit - - 25,778 37.4% -
SG&A - - 19,961 28.9% -
Operating Profit 5,200 8.0% 5,816 8.4% 111.8%
Ordinary Profit 5,000 7.7% 5,136 7.4% 102.7%Quarterly Net ProfitAttributable to Parent
vs Forecast
3,300 5.1% 3,614 5.2% 109.5%
Copyright 2015 Nichi-Iko Pharmaceutical Co., Ltd. P,4
Consolidated Fiscal Year VS 2Q Forecast
FY20142Q
FY20152Q
Copyright 2015 Nichi-Iko Pharmaceutical Co., Ltd. P,5
Operating Profit
4,410 5,816
Net Sales increase +8,039
COGS increase △4,753 Sales Promotion
Cost increase △1,407
R&D Expense increase △493
Other SG&A decrease
+20
(¥million)
Cash atbiginning of
period
Cash at end ofperiod
Copyright 2015 Nichi-Iko Pharmaceutical Co., Ltd. P,6
Cash Flows
13,609
9,299
CF from operating △1,953
CF from investing △6,129
Dividends paid △853
Other CF from financing
+4,725
Effect of exchange rate changes
△100
(¥million)
(\million)Distribution
Channel Sales % Sales %
Wholesalers 47,868 78.5% 55,744 80.8% 7,876 116.5%
Agencies 5,312 8.7% 5,467 7.9% 155 102.9%
Others 7,769 12.7% 7,776 11.3% 7 100.1%
Total 60,949 100.0% 68,987 100.0% 8,038 113.2%
FY2014 2Q FY2015 2QYOYVariance
Copyright 2015 Nichi-Iko Pharmaceutical Co., Ltd. P,7
(¥million)
The non-consolidated sales of GE products through wholesaler channel increased by 21.5% from the same period .of the previous year.
47,868 55,744
5,312
5,467 7,769
7,776
0
20,000
40,000
60,000
80,000
FY20142Q
FY20152Q
Others
Agencies
Wholesalers
Sales Performance by Distribution Channel
Group M Group S Group A Group T Group Ta Others
FY2014 2Q FY2015 2Q
31.2%
21.9%18.8%
12.2%
10.5%
5.4%
Group M
Group S
Group A
Group T
Group Ta
Others
Copyright 2015 Nichi-Iko Pharmaceutical Co., Ltd. P,8
YOY +26.9%
+18.5% +16.8%
+7.0% +17.1%
+14.2%
Comparison of Performance by Wholesalers
Share of FY2015 2Q
(\million)FY2014
2QFY2015
2Q Variance YOY
GE 50,043 59,194 9,151 118.3%
LLP 7,072 6,266 -806 88.6%
50,043 59,194
7,072
6,266
0
20,000
40,000
60,000
80,000
FY20142Q
FY20152Q
LLP
GE
Copyright 2015 Nichi-Iko Pharmaceutical Co., Ltd. P,9
+18.3%
△11.4%
(¥million)
Sales Performance by Category of Products
4,700 5,098
1,651 1,6473,079 3,3991,490 1,5921,393 1,4303,021
3,595
3,4913,915
3,221
3,9872,392
2,7442,247
2,8203,607
4,843535
1,479
2,816
0
10,000
20,000
30,000
40,000
FY20142Q
FY20152Q
Listed in2015
Listed in2014
Listed in2013
Listed in2012
Listed in2011
Listed in2010
Listed in2009
Listed in2008
Listed in2007
Listed in2006
Listed in2005
Listed in2004
Listed in2003
Copyright 2015 Nichi-Iko Pharmaceutical Co., Ltd. P,10
(\million)FY2014
2QFY2015
2Q Variance YOY
0 2,816 - -
535 1,479 944 276.4%
3,607 4,843 1,236 134.3%
2,247 2,820 573 125.5%
2,392 2,744 352 114.7%
3,221 3,987 766 123.8%
3,491 3,915 424 112.1%
3,021 3,595 574 119.0%
1,393 1,430 37 102.7%
1,490 1,592 102 106.8%
3,079 3,399 320 110.4%
1,651 1,647 -4 99.8%
4,700 5,098 398 108.5%
Listed in2015
Listed in2014
Listed in2013
Listed in2012
Listed in2011
Listed in2010
Listed in2009
Listed in2008
Listed in2007
Listed in2006
Listed in2005
Listed in2004
Listed in2003
(¥million)
Sales Performance of Generic Products by NHI Listed Year
Copyright 2015 Nichi-Iko Pharmaceutical Co., Ltd. P,11
No. ofClients
YOYSales
YOYNo. of Clients
No. ofClients
YOYSales
YOYNo. of Clients
All 114,909 121.8% 102.2% 116,229 121.9% 101.1%
DPC Hospital 1,557 119.3% 100.7% 1,558 125.2% 100.1%
Pharmacy 54,399 131.0% 103.4% 55,626 123.1% 102.3%
FY2015 2QFY2014 2QGE
Sales Performance by Medical Institutions
SalesComposition
No. ofClients
SalesComposition
No. ofClients
CoveredRatio Sales No. of
Clients
All - 100.0% 135,552 100.0% 136,344 - 117.1% 100.6%
Hospital 8,552 18.6% 8,404 18.0% 8,408 98.3% 113.5% 100.0%
DPC Hospital 1,581 11.0% 1,559 11.0% 1,562 98.8% 117.4% 100.2%
Pre-DPC Hospital 146 0.2% 142 0.2% 143 97.9% 109.0% 100.7%
Clinic 104,730 12.9% 65,852 12.1% 65,580 62.6% 110.2% 99.6%
Pharmacy 57,841 61.1% 55,085 62.1% 56,170 97.1% 119.0% 102.0%
Others - 7.4% - 7.8% - - 122.8% -
All ProductsTotal No. ofInstitutionsin Japan
FY2014 2Q FY2015 2Q YOY
Launching Date FY2013 FY2014 FY2015 FY2016No. of Productsto be launched
20 ingredients39 product listing
14 ingredients30 product listing
18 ingredients37 product listing
(10 ingredients)
Original productsLivalo®
Calblock®Valtrex®
Diovan®Blopress®
Preminent®
Plavix®Glivec (Gleevec)®
J Zoloft®
Zyprexa®Co-DIO®
(Combination Tablets)
Products between FY2014 and FY2017
Copyright 2015 Nichi-Iko Pharmaceutical Co., Ltd.
Generic products launched in Jun. 2015 9 ingredients 17 products
Scheduled generic products to be launched in Dec.2015 9 ingredients 20 products • Amvalo Combination tablets (EXFORGE Combination Tablets® Generic) • Sertraline Tablets 25mg/50mg(J Zoloft® Generic) • Amaluet Combination Tablets No.1/2/3/4(Caduet combination Tablets® Generic) • Valsartan OD Tablets 20mg/40mg/80mg/160mg(Diovan OD Tablets® Generic) • Levocarnitine Chloride tablets100mg/300mg(L-Cartin® Generic) • Metformin Hydrochloride Tablets 500mgMT(Metgluco® Generic) • TAZOPIPE Combination for I.V. Injection 2.25/4.5(Zosyn® Generic) • Maxacalcitol for I.V. Dialysis 2.5μg/5μg/10μg(Oxarol® Generic) • Picillibacta for I.V. Injection 3g(Unasyn-S® Generic) ※One combination product is counted as one ingredient.
P,12
Generic products to be Launched in Jun. and Dec. 2015
Copyright 2015 Nichi-Iko Pharmaceutical Co., Ltd.
Biosimilar & Overseas
Rituximab ( Brand name drug :
Rituxan®)
Development candidates
Darbepoetin α ( Brand name drug :
Nesp®)
Domestic Market Size
Infliximab : approx. ¥90bn (Global) : approx. $9.9bn Trastuzumab : approx. ¥37bn Darbepoetin α : approx. ¥65bn Rituximab : approx. ¥35bn
Sep,2016 Approval (E)
Sep,2015 Filed
Sales target ¥6.5 billion / yr
Trastuzumab (Brand name drug:
Herceptin®)
2019 Filing (E) 2020 Approval (E)
2017年 第Ⅲ相臨床試験
USA 2019 Approval (E)
2018 Filing (E)
Sales target ¥23 billion / yr
Simultaneous Development
in Japan & USA
Early 2016 Clinical trials P1
Nov,2016 Launch(E)
Early 2016 Clinical trials P1 (E)
Japan
P,13
Infliximab (Brand name drug:
Remicade®)
Copyright 2015 Nichi-Iko Pharmaceutical Co., Ltd. P,14
Thailand
Malaysia
Vietnam
Hong Kong
Overseas (Southeast Asia) Aug. 2015, received manufacturing and marketing approval in Vietnam
Approved products • Fosfomycin calcium capsules 250mg ”Nichiiko” • Fosfomycin calcium capsules 500mg ”Nichiiko”
To be launched in Jan. 2016 Distribution, sales, marketing to be developed through business partner, Hanoi Pharma
Southeast Asia Development Status Hong Kong
• 3 ingredients 5 products have been already launched • 9 ingredients 13 products are to be launched by FY2019 (including products already launched)
Thailand • Nichi-Iko brand is penetrating the market by repackaging local
drug manufacturer's preparations under the Nichi-Iko brand • Preparing application for Nichi-Iko preparations:
11 ingredients 18 products are to be launched by FY2018 Vietnam
• Received manufacturing and marketing approval for 1 ingredient 2 products • 8 ingredients 11 products are to be launched by FY2017 (including products
already approved) Malaysia
• Preparing application for Nichi-Iko preparations: 10 ingredients 16 products are to be launched by FY2019
Forward-Looking Statements
The information contained in this document is not intended as solicitation material for buying or selling the company’s shares.
Earnings forecasts and other future forecasts contained herein have been made by the company based on information available at the time the material was compiled and encompass potential risks and uncertainties.
Accordingly, actual results may differ from forecasts for a variety of reasons. The company and any other information sources for this document bear no
responsibility for damages or losses resulting from the use of this information.
Contact information for any questions: Nichi-Iko Pharmaceutical Co., Ltd. Corporate Planning Office Phone: +81-76-442-7026 E-mail: [email protected]