Year Ended March 31, 2013nichiiko-ir.irbridge.com/en/Library/Presentation/main/0... · Year Ended March 31, 2013 Results of Full year Settlement of accounts supplementary material

Year Ended March 31, 2013 Results of Full year

Settlement of accounts supplementary material (Apr.1 2013 to Mar.31 2014)

May 15 ,2013

Nichi-Iko Pharmaceutical Co., Ltd.

(Code No. 4541 1st section of TSE)

Challenge to global market with the Power of Creation

We, Nichi-Iko, provide value-added, high quality generic products which meet various requirements from patients, doctors, pharmacists, wholesalers and pharmaceutical companies in the global market as one of the most respected, well established generic company in the world.

Mission statement The 6th Medium-term Business Plan

Copyright ©2013 Nichi-Iko Pharmaceutical Co., Ltd. All rights reserved. 2

Global Top 10 Generic Pharmaceutical Company Vision

Progress of Pyramid Plan


（million yen） FY2012 Results / Sales(%)FY2012

(Plan at March 2012) / Sales(%) YTDFY2012

(Revised Plan at 2Q FY2012)/ Sales(%) YTD

Sales 93,926 - 92,500 - 101.5% 94,000 - 99.9%

COGs 57,260 61.0% 56,100 60.6% 102.1% 56,700 60.3% 101.0%

Gross Profit 36,645 39.0% 36,400 39.4% 100.7% 37,300 39.7% 98.2%

SG&A Expenses 28,416 30.3% 28,100 30.4% 101.1% 28,800 30.6% 98.7%

Operating Income 8,229 8.8% 8,300 9.0% 99.1% 8,500 9.0% 96.8%

Ordinary Income 8,470 9.0% 8,000 8.6% 105.9% 8,300 8.8% 102.0%

Net Income 5,129 5.5% 4,800 5.2% 106.9% 5,000 5.3% 102.6%

Capital Expenses 10,709 8,500 126.0% 9,900 108.2%

R&D Expenses 3,250 4,400 73.9% 4,000 81.3%

Depreciation Cost 4,592 4,600 99.8% 4,800 95.7%

Quarterly Business Performance of FY2012


Sales （million yen）

Operating Income

(million yen）

23140 22739

25981

22063

2110

1559

2898

1661

1000

1500

2000

2500

3000

3500

4000

0

5000

10000

15000

20000

25000

30000

1Q 2Q 3Q 4Q

Sales

Operating Income

The Income Comparison of Consolidated Fiscal Year

Copyright ©2013 Nichi-Iko Pharmaceutical Co., Ltd. All rights reserved. 5 ＊We have changed to March 31 fiscal year-end from November 30 from the year ended March 31, 2012.

（Million yen）FY2011

(Dec.2010-May.2011)/ Sales(%) FY2012 / Sales(%) YTD

Net Sales 77,740 - 93,926 - 120.8%Cost of Sales 46,423 59.7% 57,260 61.0% 123.3%Gross profit 31,304 40.3% 36,645 39.0% 117.1%SG&A Expenses 23,812 30.6% 28,416 30.2% 119.3%

Labor Expenses 4,404 5.7% 4,810 5.1% 109.2%R&D Expenses 2,065 2.7% 3,250 3.5% 157.4%

Sales Promotion cost 10,336 13.3% 12,187 13.0% 117.9%Others 7,007 9.0% 8,168 8.7% 116.6%

Operating Income 7,492 9.6% 8,229 8.8% 109.8%Non-Operating Income 361 0.5% 575 0.6% 159.3%

Non-Operating Expenses 543 0.7% 334 0.4% 61.5%Ordinary Income 7,309 9.4% 8,470 9.0% 115.9%

Exstraordinary Profit 29 0.0% 160 0.2% 549.1%Exstraordinary Loss 753 1.0% 461 0.5% 61.3%

Net Income 3,908 5.0% 5,129 5.5% 131.3%

Capital Expenditure 5,318 10,709 201.4%

Depreciation Cost 4,201 4,592 109.3%

Sales of Performance by Medical Institutions

DPC, Hospitals Undergoing DPC Preparation and Pharmacy have increased sales YOY 123% Copyright ©2013 Nichi-Iko Pharmaceutical Co., Ltd. All rights reserved. 6

Salescomposition

No. of Clients

Salescomposition

No. of Clients

RatioSales

GrowthNo. of Clients

100% 130,268 100% 133,176 113.9% 102.2%

Hospitals 6,990 9.7% 6,841 9.1% 6,845 97.9% 106.9% 100.1%

DPC Hospitals 1,504 12.0% 1,475 11.6% 1,471 97.8% 110.0% 99.7%

Hospitals UnderＤＰＣPreperation

129 0.2% 126 0.2% 127 98.4% 118.1% 100.8%

Clinic 103,375 18.0% 65,123 16.0% 66,064 63.9% 101.3% 101.4%

Pharmacy 55,231 52.9% 51,420 55.8% 53,153 96.2% 120.1% 103.4%

Others - 7.2% 5,283 7.3% 5,516 - 116.4% 104.4%

InstitutionTotal No. ofInstitutions in Japan

FY2011 FY2012 YOY

ALL

Sales Performance by Distribution Channel


（million yen）

（million yen）

66,033 78,126

8,105

8,764 6,335

7,034

0

10,000

20,000

30,000

40,000

50,000

60,000

70,000

80,000

90,000

100,000

FY2011

(Monthky Based)

FY2012

Others

Agencies

Wholesalers

Sales byMarketing Channel

FY2011(Based on monthly

setllement of accounts)FY2012

SalesGrowth

YOY

Wholesalers 66,033 78,126 12,093 118.3%

Agencies 8,105 8,764 659 108.1%

Others 6,335 7,034 699 111.0%

Total 80,474 93,926 13,452 116.7%

Sales Performance by Category of the Products


（million yen）

（million yen）

62,371

75,487

18,004

17,684 99

755

0

10,000

20,000

30,000

40,000

50,000

60,000

70,000

80,000

90,000

100,000

FY2011

（Monthly Based）

FY2012

Other

LLP

ＧＥ

FY2011（Based on monthly

settlement of accounts）FY2012 Sales Growth YOY

ＧＥ 62,371 75,487 13,116 121.0%

LLP 18,004 17,684 -320 98.2%

Other 99 755 656 759.2%

Total 80,474 93,926 13,452 116.7%

Sales have increased in listed products since 2003. (YOY123.5%） Copyright ©2013 Nichi-Iko Pharmaceutical Co., Ltd. All rights reserved. 10

（million yen）

（million yen）

Sales Performance of Generic Products by NHI Drug Price Listed Year

7,764 8,265

3,225 3,350

5,592 5,438

2,375 2,554 2,304 2,565

4,224 4,941

4,354 5,073

2,351

3,689 1,727

4,180 1,814

0

5,000

10,000

15,000

20,000

25,000

30,000

35,000

40,000

45,000

FY2011 FY2012

Listed Iin 2012

Listed Iin 2011

Listed Iin 2010

Listed Iin 2009

Listed Iin 2008

Listed Iin 2007

Listed Iin 2006

Listed Iin 2005

Listed Iin 2004

Listed Iin 2003

FY2011 FY2012 Sales Growth YOY

Listed in 2012 0 1,814 1,814 -

Listed in 2011 1,727 4,180 2,453 242.1%

Listed in 2010 2,351 3,689 1,338 156.9%

Listed in 2009 4,354 5,073 719 116.5%

Listed in 2008 4,224 4,941 718 117.0%

Listed in 2007 2,304 2,565 261 111.3%

Listed in 2006 2,375 2,554 180 107.6%

Listed in 2005 5,592 5,438 -154 97.3%

Listed in 2004 3,225 3,350 125 103.9%

Listed in 2003 7,764 8,265 501 106.5%

Nichi-Iko Group Undertakings

Contents Strengthening of production Generic drugs to be launched in Jun. and Dec. 2013 Auto-generic (Authorized Generic) Strategic alliance with Sanofi Biosimilar Anticancer drugs Overseas expansion 100 billion yen breakthrough! Settlement forecast for the FY ending Mar. 2014 Social contribution / Incentives for directors and other workers Construction of the new headquarters


Strengthening of production (stable supply / cost reduction / in-house production) (1)

Pyramid Bldg. Operation started in Mar. 2013 Capacity: 2-3 billion tablets / year 7-8 billion tablets / year (full capacity operation) with the Pentagon Bldg. Investment amount: approx. 5.8 billion yen (original plan: 4.5 billion yen, acceleration

of budget within the mid-term business plan period: 1.3 billion yen)

Securing production capacity / cost reduction through in-house production for the achievement of the Pyramid plan

Securing future space and create a flexible design that can handle market trend changes

12

(New) Pyramid Bldg. (completed in Mar.

2013)

Pentagon Bldg. (completed in

Feb. 2010)

Honeycomb Bldg. (completed in

Oct. 2011)


Aichi Plant Equipment installation for the production of lyophilization injections Operation started in Apr. 2013 Production capacity: 4million / year Investment amount: approx. 2.7 billion yen

Strengthening drug production techniques for premium quality Establish cost reduction and a stable supply through in-house production

13

Pentagon棟 2010年2月竣工


Production consolidated (disinfectants) with Yakuhan Pharmaceutical Yamagata Plant ⇒ Yakuhan Pharmaceutical …More than 1.6 times of the

production volume of Yakuhan Pharmaceutical Schedule: Production from Dec. 2012 and Shipment from Mar. 2013 Cost reduction due to the improvement of operating ratio

Yamagata Plant

Planning the extension and reconstruction of the administration and quality control buildings

Staring production of topical agent from Dec. 2013 Promoting cost reduction through in-house production


Supplementary Product List Schedule (Supplement plan for the FY ending in Mar. 2013 to the FY ending in Mar. 2016)

Launching Date of Products Mar. 2013 Mar. 2014 Mar. 2015 Mar. 2016

Number of Products to be launched 21 ingredients 37 product listing 39 30 45

Sales for 2011 original drug (hundred million yen: drug price based)

approx. 3,700 approx. 3,400 approx. 3,500 approx. 3,100

Main products Nu-lotan

Paxil Myslee

Livalo Calblock Valtrex

Diovan Blopress

Preminent

Plavix Glivec (Gleevec)

J Zoloft

Generic drugs to be launched in Jun. and Dec. 2013


Scheduled generic drugs to be launched for FY2013 20 ingredients 39 standards Launched in Jun.2013 10 ingredients 19 standards

Scheduled supplement articles for Dec.2013 10 ingredients 20 standards

• Fexofenadine Hydrochloride Tablets 30 mg / 60 mg • Risedronate Tablets 17.5 mg • Pitavastacin calcium Tablet 1mg /2 mg • Tacrolimus Tablet 0.5mg/1mg/5 mg • Azithromycin Tablet 250 mg / 500 mg • Donepezil 10mg products (Tablet, OD Tablet, Jelly )

Biosimilar

State of development progress of Biosimilar infliximab (Remicade) Already concluded a joint development agreement with Sanofi Completed the phase I clinical trial (repeated-dose administration) for patients Planning to apply for approval in the FY ending Mar. 2015 To be launched on FY ending Mar. 2016 The 5th year plan for Biosimilar infliximab (Remicade) after the launch to the

market • Annual sales amount: approx. 100,000 vials (approx. 12% amount based)

• Annual sales (drug price based): approx. 5.0 billion yen


Anticancer drugs - Products planned for the launch on the market in FY ending in Mar. 2016

Product development schedule for products planned for the launch on the market in FY ending in Mar. 2016 and products already on the market.

(Includes the carrying of our products, jointly developed products, and other company products)

Establishment of an oncology group at the sales headquarters (October 1st 2012) Established at the Dept. of the DPC wide area hospital for the purpose of selling anticancer drugs Promotion of sales at DPC / foundation hospital by strengthening sales

Establishment of a cancer-inhibiting drug promotion department (October 1st 2012) Development promotion of generic anticancer drugs

New drugs to be launched on the market Anastrozole Tablets 1 mg * Launched market in Dec. 2012 Irinotecan Hydrochloride I.V. Infusion 40 mg / 100 mg * Scheduled to be listed in Jun. 2013

Anticancer drugs

17

13/3月期 14/3月期 15/3月期 16/3月期

上市規格数（規格）

1品目 4品目 6品目 6品目

Mar. 2013 Mar. 2014 Mar. 2015 Mar. 2016

No. of items to be placed on the market (Items) 1 item 4 items 6 items 6 items

Copyright ©2013 Nichi-Iko Pharmaceutical Co., Ltd. All rights reserved.

各国申請予定品目（第１次選定品目）

既申請品目 13/3月期 14/3月期 15/3月期 16/3月期

香港 5品目 2 品目

マレーシア１品目 6 品目

タイ 1 品目 8品目

Application status in Hong Kong, Malaysia, and Thailand

Apr. 2013 Set up a representative office in Bangkok, Thailand accelerating the speed of overseas business expansion

Jun. 2013 Planning to start the sales of NIKP-GLIMEPIRIDE TABLET 3 mg in Hong Kong

Items planned to be applied for in each country (1st selection items)

Already applied for items Mar. 2013 Mar. 2014 Mar. 2015 Mar. 2016

Hong Kong 5 items 2 items

Malaysia 1 item 6 items

Thailand 1 item 8 items

Expansion overseas


Fexofenadine Hydrochloride Tablets “SANIK” * (original name: Allegra) First auto-generic in Japan Preparation with the same drug substance, additives, and manufacturing method

as the original drug The only drug with permission such as patent rights from the Sanofi Group Manufacturer: Sanofi Nichi-Iko K.K. Distributor: Nichi-Iko Pharmaceutical Co.,

Ltd. To be launched on Jun. 2013

* “SANIK” is the trade name for the joint venture between Nichi-Iko Pharmaceutical Co., Ltd. and Sanofi K.K. “

First auto-generic in Japan


20

(Billion yen)

First domestic generic manufacturer to break 100 billion yen in sales

Copyright ©2013 Nichi-Iko Pharmaceutical Co., Ltd. All rights reserved.

0

20

40

60

80

100

120

Nov.2001

Nov.2002

Nov.2003

Nov.2004

Nov.2005

Nov.2006

Nov.2007

Nov.2008

Nov.2009

Nov.2010

Nov.2011

Mar.2012

Mar.2013

Mar.2014

103

Settlement forecast for the FY ending Mar.2014


（million yen） FY2012 / Sales(%)Forecasts for

FY2013/ Sales(%) YOY

Net Sales 93,926 - 103,000 - 109.7%

Cost of Sales 57,260 61.0% 62,200 60.4% 108.6%

Gross Profit 36,645 39.0% 40,800 39.6% 111.3%

SG&A Expenses 28,416 30.3% 31,800 30.9% 111.9%

Operating Income 8,229 8.8% 9,000 8.7% 109.4%

Ordinary Income 8,470 9.0% 8,800 8.5% 103.9%

Net Income 5,260 5.6% 5,500 5.3% 104.6%

Capital Expenditures 10,709 3,500 32.7%

R&D Expenses 3,250 5,000 153.8%

Depreciation Cost 4,592 6,000 130.7%

Dividend per share　32.00 yen

Interim Dividend 16yenTerm End Dividend 16yen

32.00 yen ＊PlanInterim Dividend 16yen

Term End Dividend 16yen

Construction of the new headquarters


Construction of the new headquarters Scheduled to be completed in Jun. 2015 Investment amount: 3.5 billion yen

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.

Please contact the number below for any related questions: Nichi-Iko Pharmaceutical Co., Ltd. Corporate Planning Office Phone: +81-76-442-7026 E-mail: [email protected]

Documents

Year Ended March 31, 2013nichiiko-ir.irbridge.com/en/Library/Presentation/main/0... · Year Ended March 31, 2013 Results of Full year Settlement of accounts supplementary material