Year Ended March 31, 2014 Results of 2 nd Quarter Settlement of accounts supplementary material (Apr to Sep.30, 2013)

Transcription

1 Year Ended March 31, 2014 Results of 2 nd Quarter Settlement of accounts supplementary material (Apr to Sep.30, 2013) Challenge to global market through the Power of Creation Dec Nichi-Iko Pharmaceutical Co., Ltd. (Code No st section of TSE)

2 Mission statement The 6 th Medium-term Business Plan 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. Copyright 2013 Nichi-Iko Pharmaceutical Co., Ltd. All rights reserved. 2

3 Consolidated fiscal year Income Comparison (Million yen) 2ndQ 2013 / Sales(%) 2ndQ2014 / Sales(%) YTD Net Sales 45,880-49, % Cost of Sales 27, % 30, % 109.2% Gross profit 17, % 19, % 106.0% SG&A Expenses 14, % 15, % 107.2% Labor Expenses 2, % 2, % 102.9% R&D Expenses 1, % 1, % 107.8% Sales Promotion cost 5, % 6, % 114.7% Others 4, % 4, % 99.8% Operating Income 3, % 3, % 101.3% Non-Operating Income % % 96.7% Non-Operating Expenses % % 185.4% Ordinary Income 3, % 3, % 96.9% Exstraordinary Profit 0 0.0% 1 0.0% Exstraordinary Loss % 9 0.0% 5.7% Net Income 2, % 2, % 102.8% Capital Expenditure 4,745 2, % Depreciation Cost 2,257 2, % Copyright 2013 Nichi-Iko Pharmaceutical Co., Ltd. All rights reserved. 3

4 Comparison of Performance by Institutions Institution Total No. of Institutions in Japan 2ndQ ndQ 2014 YOY Sales No. of Sales No. of Ratio composition Clients composition Clients Sales Growth No. of Clients ALL 100% 132, % 134, % 101.4% Hospitals 6, % 6, % 6, % 104.3% 100.0% DPC Hospitals 1, % 1, % 1, % 105.4% 100.3% Hospital Under DPC Preperation % % % 104.7% 100.0% Clinic 103, % 65, % 66, % 106.1% 100.2% Pharmacy 56, % 53, % 54, % 112.4% 102.8% Others - 6.3% 4, % 5, % 104.2% Copyright 2013 Nichi-Iko Pharmaceutical Co., Ltd. All rights reserved. 4

5 Comparison of Performance by Distribute channel (million yen) 60,000 Others 50,000 40,000 3,688 3,960 3,920 4,842 Agencies Wholesalers (million yen) 30,000 Sales by Marketing Channel 2ndQ ndQ 2014 Sales Ratio Sales Ratio Sales Growth YOY 20,000 38,232 40,764 Wholesalers 38, % 40, % 2, % Agencies 3, % 4, % % 10,000 Others 3, % 3, % % 0 2ndQ ndQ 2014 Total 45, % 49, % 3, % Copyright 2013 Nichi-Iko Pharmaceutical Co., Ltd. All rights reserved. 5

6 Comparison of Performance by Wholesalers 2 nd Q Sales Share YOY 6.4% 11.6% 14.4% 18.7% 27.6% 21.3% M S A T Ta Other 2ndQ ndQ 2014 M S A T Ta Other Copyright 2012 Nichi-Iko Pharmaceutical Co., Ltd. All rights reserved. 6

7 Sales Performance by Category of the Products million yen) 60,000 50, ,213 40,000 9,151 (million yen) 30,000 Other LLP 2ndQ ndQ 2014 Sales Growth YOY 20,000 36,383 40,967 GE GE 36,383 40,967 4, % LLP 9,151 8, % 10,000 Other % 0 2ndQ ndQ 2014 Total 45,880 49,526 3, % Copyright 2013 Nichi-Iko Pharmaceutical Co., Ltd. All rights reserved. 7

8 Sales Performance of Generic Products by NHI Drug Price Listed Year million yen) 30,000 25,000 20,000 15,000 10,000 5, ,868 1,682 2,499 2, ,866 2,539 2,341 2,998 2,613 1,082 1,162 1,177 1,290 2,805 2,718 1,878 1,816 Listed in 2013 Listed in 2012 Listed in 2011 Listed in 2010 Listed in 2009 Listed in 2008 Listed in 2007 Listed in 2006 Listed in 2005 Listed in 2004 Listed in 2003 (million yen) 2ndQ ndQ 2014 Sales Growth YOY Listed in Listed in ,866 1, % Listed in ,868 2, % Listed in ,682 2, % Listed in ,499 2, % Listed in ,316 2, % Listed in ,082 1, % Listed in ,177 1, % Listed in ,805 2, % 0 4,513 4,900 Listed in ,878 1, % Listed in ,513 4, % 2ndQ ndQ 2014 Copyright 2013 Nichi-Iko Pharmaceutical Co., Ltd. All rights reserved. 8

9 First auto-generic in Japan 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. Launched on Jun. 2013; Building up sales in time to meet seasonal demand * SANIK is the trade name for the joint venture between Nichi-Iko Pharmaceutical Co., Ltd. and Sanofi K.K. Copyright 2013 Nichi-Iko Pharmaceutical Co., Ltd. All rights reserved. 9

10 Generic drugs to be launched in Jun. and Dec Supplementary Product List Schedule (Supplement plan for the FY ending in Mar to the FY ending in Mar. 2016) Launching Date of Products Mar Mar Mar Mar Number of Products to be launched 21 ingredients 37 product listing 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 Scheduled generic drugs to be launched for FY ingredients 39 standards Launched in Jun ingredients 19 standards Scheduled supplement articles for Dec ingredients 20 standards Besoften oiled based cream 0.3% Valaciclovir tablets 250mg/500 mg Valaciclovir glanule 50% Nateglinide tablets 30 mg / 90 mg Olopatadine Hydrochloride OD Tablets 2.5 mg /5 mg Cilostazol OD Tablets 50 mg / 100 mg Irinotecan Hydrochloride I.V. Infusion 40 mg / 100 mg Copyright 2013 Nichi-Iko Pharmaceutical Co., Ltd. All rights reserved. 10

11 Nichi-Iko acquired Astellas Fuji plant(press Release on Sep. 27, 2013) Acquisition of the Astellas Pharma Tech (manufacturing subsidiary of Astellas Pharma)Fuji plant New subsidiary in Sizuoka Prefecture (scheduled) Scheduled to start operating as a subsidary of Nichi-Iko on April 1, 2014 Outline of Fuji Plant Plant Location:Fuji-city, Shizuoka Site area:95,506m2 Building area:57,789m2 No. of Employee:370 Dosage form:tablet, Capsule, Powder, Granule, Injection Actual annual production:2 billion tablets / year, 5 million injections / year Annual production capacity:3 billion tablets 10 million injections / year Synergy Effect Ensure a stable product supply by increasing production capacity Cost reduction by going ahead with in-house production Cost reduction by transition of large-lot production Succession of high technological skills and high quality control capabilities Strengthening the risk management by decentralization of production bases Copyright 2013 Nichi-Iko Pharmaceutical Co., Ltd. All rights reserved. 11

12 Production Sites & R&D center Toyama(Toyama 1st) Yakuhan Pharmaceutical Pyramid Bldg. Pentagon Bldg. Honeycomb Bldg. Antiseptic Tablet & Capsule Pyramid Bldg. Operation started in April 2013 (Toyama 2nd) Yamagata Plant Powder & Granulation External products Aichi plant New subsidiary in Sizuoka Prefecture (scheduled) Saitama Plant Injection (Lyoiphilization) Operation started in April 2013 Tablet & Injection Oral Jelly Eye drop medicines & Divided Liquid Copyright 2013 Nichi-Iko Pharmaceutical Co., Ltd. All rights reserved. 12

13 Capital tie-up with Binex To accerate biosimilar business through acquisition of 12.6% of Binex shares. Company Profile Headquaters location: 480-2, Jangrimdong, Sahagu, Pusan, Korea Establishment:December 1957 Representative:Myoung-Ho Jeong Capital: billion won(as of June 30, 2013) Turnover:52.49 billion won(period ending on December 31, 2012) Employees:324(December 31, 2012) Main business operations:commissioned manufacture of biologics, manufacture and sales of pharmaceutical Synergy Effects Accumulates know-how for manufacturing of biosimilar preparations and secures a production base. Outstanding technologies boost biosimilar business Steps up overseas expansion of biosimilar business Leads to introduction of Nichi-Iko products in the Korean market. Copyright 2013 Nichi-Iko Pharmaceutical Co., Ltd. All rights reserved. 13

14 Biosimilar Activities Joint Development Contract Manufacture Products scheduled for start of clinical development testing under the 6 th Medium- Term Business Plan Nichi-Iko owned 44.9% share of Aprogen Capital tie-up Nichi-Iko owned 12.6% share of Binex Administration KBCC Korean Biotechnology Commercialization Centre Infliximab(Remicade) Rituximab(Rituxan) Trastuzumab(Herceptin) Darbepoetin α(nesp) Expansion Overseas To overseas C R O Remicade(infliximab) Overseas Domestic Changes in clinical development contract(for infliximab) in Japan Joint development agreement terminated(nichi-iko to be the sole developer) Rituxan (Rituximab) Herceptin (Trastuzumab) Nesp (Darbepoetin α) CRO to be outsourced to Sanofi Copyright 2013 Nichi-Iko Pharmaceutical Co., Ltd. All rights reserved. 14

15 Expansion overseas To accelerate expansion into the Southeast Asia region through a tie-up with BioLab. Company Profile Headquaters location:625, Bangpoo Industrial Estate, Moo 4, Soi 7A, A. Muang, Samutprakarn 10280, Thailand Establishment:1981 Representative:Rachod Thakolski Capital:85 million bahts Employee:Approx.700 Main business:manufacture of pharmaceuticals First of ASEAN countries to receive ISO9001 certification First in Thailand to receive PIC/S GMP certification in 2009; Acquired PIC/S GMP certification for 7dosage forms by August, Areas of collaboration: Support for Nichi-Iko s applications for approval of the products it intends to market in Thailand. Repackaging of Nichi-Iko products for local market. Marketing of BioLab products, which BioLab has been approved to manufacture and sell under the Nichi-Iko brand in the Thai market. Synergy effects Expedites processing of applications for approval Accelerates pace of overseas business expansion Copyright 2013 Nichi-Iko Pharmaceutical Co., Ltd. All rights reserved. 15

16 Postponement of construction of the new head office building Postponement of construction of the new head office building The company has reached the conclusion that the construction of the new head office building, which was scheduled for completion in 2015, is not feasible at this time as the estimated cost exceeds the initial budget(3.5 billion yen) due to rising construction-related costs as well as the Company s need to continue investing in the areas of development and manufacturing. Copyright 2013 Nichi-Iko Pharmaceutical Co., Ltd. All rights reserved. 16

17 Settlement Forecast for the ending Mar (million yen) 2ndQ 2014 / Sales(%) 2H 2014 (Forecast) / Sales(%) FY 2014 (Forecast) / Sales(%) Pyramid Plan 2nd Full Year / Sales(%) YTD Sales 49,526-53, , , % COGs 30, % 31, % 62, % 62, % 99.8% Gross Profit 19, % 21, % 40, % 40, % 100.2% SG&A Expenses 15, % 17, % 32, % 31, % 102.5% Operating Income 3, % 4, % 8, % 9, % 92.2% Ordinary Income 3, % 4, % 8, % 8, % 90.9% Net Income 2, % 2, % 5, % 5, % 94.5% Capital Expenses 2,335 3,065 5,400 3, % R&D Expenses 1,797 3,903 5,700 5, % Depreciation Cost 2,811 3,089 5,900 6, % Copyright 2013 Nichi-Iko Pharmaceutical Co., Ltd. All rights reserved. 17

18 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: ir@nichiiko.co.jp