Year Ended March 31, 2016 - nichiiko-ir.irbridge.comnichiiko-ir.irbridge.com/en/Library/Presentation/main/0... · Year Ended March 31, 2016 ... value-added, high quality generic products

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%


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%


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%


Consolidated Fiscal Year VS 2Q Forecast

FY20142Q

FY20152Q


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


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


（¥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


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


+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


（\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


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



（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®）


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]

Year Ended March 31, 2016 - nichiiko-ir.irbridge.comnichiiko-ir.irbridge.com/en/Library/Presentation/main/0... · Year Ended March 31, 2016 ... value-added, high quality generic products

Documents