Financial Results. for FY 2010 ended March ~For healthy and affluent lives of people around the world~
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1 Financial Results for FY 2010 ended March 2011 ~For healthy and affluent lives of people around the world~ May 24, 2011 TRANS GENIC INC. Note: This material includes forward-looking statements based on assumptions and beliefs in light of the information currently available to management and subject to significant risks and uncertainties. Actual financial results may differ materially depending on a number of factors including adverse economic conditions, delays in new product launch, pricing and product initiatives of competitors, the inability of the company to market existing and new product effectively.
2 Table of Contents Ⅰ. Overview of Financial Results for the Year Ended March Consolidated Financial Results Highlight 2. Overview of Business Performance by Categories Ⅱ. Business Topic 1.Comprehensive Business Collaboration with Immuno-Biological Laboratories Co., Ltd. Ⅲ. Basic Strategies and Consolidated Business Forecast for the Year Ending March Consolidated Business Forecast Ⅳ. Current Status of Research and Development 1. Research and Development Strategies 2. Status of Development Pipeline 3. Development Pipeline Pancreatic Cancer Marker Copyright TransGenic Inc. All Rights Reserved. 1
3 Ⅰ. Overview of Consolidated Financial Results for the Year Ended March 2011 Copyright TransGenic Inc. All Rights Reserved. 2
4 Overview of Consolidated Financial Results Consolidated Financial Results Highlight Superficially decreased in revenue, achieved drastic increase in sales practically for 2 consecutive terms, and improved profit and loss FY2010 FY2009 FY2010 Change Unit:thousand yen TG,PRM Net Sales 603, ,100 94, ,734 Mouse Related Business 232, ,519 74, ,487 Antibody Related Business Reagent Agency Business Functional Food Business Reference 55,807 77,750 21,942 55,807 94, ,830 30,391 94, , ,251 - Cost of Sales 373, , , ,724 Gross Profit on Sales 230, ,433 6, ,011 SG&A Expenses 615, , , ,048 R&D Expense 143,287 55,947 87, ,266 Operating Deficit 385, , , ,037 Ordinary Loss 389, , , ,080 Net Deficit 579, , , ,769 Copyright TransGenic Inc. All Rights Reserved. 3
5 Overview of Consolidated Financial Results Overview of Business Performance by Categories Increased in sales and profit in all business segments, ended in the black, reduced further in operating cost Business Performance for FY2009 Unit:Thousand yen Mouse Antibody Reagent Food SGA Consolidated Net sales 232,487 55,807 94, , ,985 Operating Expense 181, ,555 97, , , ,187 Operating Profit 51,076 95,747 2,743 62, , ,201 Since business categories are changed in FY2010, the numbers of FY2009 are recalculated according to the new categories. Business Performance for FY2010 Unit:Thousand yen Mouse Antibody Reagent SGA Consolidated Net Sales 306,519 77, , ,100 Operating Expense 251,562 71, , , ,261 Operating Profit 54,956 6,291 22, , ,161 Increased in Sales and Profit Increased in Sales, Turned into the black Increased in Sales, Turned into the black Reduced Copyright TransGenic Inc. All Rights Reserved. 4
6 Overview of Business Performance -Mouse Related Business Sales Growth, Increased in sales and profit for 3 consecutive terms Unit: Thousand Yen FY2009 FY2010 Change Rate of Change Net Sales 232, ,519 74, % Cost of Sales 130, ,179 59, % Gross Operating Profit 102,077 (43.9%) 116,340 (38.0%) 14, % R&D Expense 13,492 19,750 6, % SGA Expense 37,509 41,632 4, % Operating Profit 51,076 54,956 3, % Since business categories are changed in FY2010, the numbers of FY2009 are recalculated according to the new categories. 1.Sales of TG Resource Bank and DNA analysis did well 2.Due to the delay of management of contracted knockout mouse production efficiency, gross profit rate decreased, and the increase in operating profit reduced compared to the increasing amount in sales. Copyright TransGenic Inc. All Rights Reserved. 5
7 Overview of Business Performance -Antibody Related Business Sales Growth, Operating profit turned into black Unit: Thousand Yen FY2009 FY2010 Change Rate of Change Net Sales 55,807 77,750 21, % Cost of Sales 5,071 24,738 19, % Gross Operating Profit 50,735 (90.9%) 53,012 (68.2%) 2, % R&D Expense 125,295 36,197 89, % SGA Expense 21,188 10,523 10, % Operating Profit 95,747 6, ,039 - Since business categories are changed in FY2010, the numbers of FY2009 are recalculated according to the new categories. 1.Sales goal of the contracted service was not accomplished, however the sales of original antibody products is in good condition. 2.Promotion of developing efficiency of new antibody product (shifted from selfdevelopment to collaborative research) brought reduction in R & D expenses to achieve a budget surplus. Copyright TransGenic Inc. All Rights Reserved. 6
8 Overview of Business Performance -Reagent Agency Business Sales Growth, Operating profit turned into black Unit: Thousand Yen FY2009 FY2010 Change Rate of Change Net Sales 94, ,830 30, % Cost of Sales 52,242 56,749 4, % Gross Operating Profit 42,196 (44.7%) 68,081 (54.5%) 25,884 (64.8%) 23 年 3 月 期 よりセグメント 区 分 を 変 更 しているため 22 年 3 月 期 の 数 値 は 変 更 後 の 新 セグメント 区 分 により 作 成 し 直 したものであります 61.3% R&D Expense 4, , % SGA Expense 40,460 45,225 4, % Operating Profit 2,743 22,855 25,599-1.Sales of cytokine and PTG products were in steady performance. 2.Sales increased by 30% due to the expanded product lines and strengthened sales. Copyright TransGenic Inc. All Rights Reserved. 7
9 Ⅱ. Business Topic Copyright TransGenic Inc. All Rights Reserved. 8
10 Comprehensive Business Collaboration with Immuno-Biological Laboratories Co., Ltd. (IBL) Existing business Though business segments are similar, each has its own characteristic and no overlap or competion - Combine both strength and synergize the business - TRANS GENIC IBL Antibody related business, Reagent agency business GANP technology Network with pharmaceutical companies and public research organization New cancer marker Laboratory animal related business Gene-Trapping technology TG Resource Bank contract service Research related business Antibody product, kit product specialized for Alzheimer disease cancer/inflammationmetabolism Utilize lab animal-related laboratory with functions and capacity, and disease model mouse Pharmaceutical related business Network with pharmaceutical companies and public research organization Challenges Complement antibody and reagent agency business Maximize the value of intellectual property Expand laboratory animal business Enrich and expand products and services Innovate new technology Review independent business operation by downsizing laboratory animal business Operative examples Reinforce the profit growth of GANP technology Lisencing-in GANP technology launched on March 11, 2011 Develop by using GANP technology, advance the added value of service Commercialize existing research technique Innovate and commercialize the promising seeds efficiently Co-development of pancreatic cancer marker launched on April 25, 2011 Utilize laboratory animal business for TRANS Utilize IBL s accumulated sales network GENIC Copyright TransGenic Inc. All Rights Reserved. 9
11 Ⅲ. Basic Strategies and Consolidated Business Forecast for the Year Ending March 2012 Copyright TransGenic Inc. All Rights Reserved. 10
12 Transition of Profit and loss for the past 7 years 1.FY2008:Decreased in net sales, improved ordinary loss 2.FY2009:Increased sales and reduced cost to go into the black 3.FY2010:Established the revenue base to accomplish a surplus in a short period 4.FY2011:Strengthening the revenue base to achieve a surplus Transition of net sales and ordinary loss Unit:million yen Net sales Sales of contract with two pharmaceutical companies Sales excluding above Ordinary loss 190 FY FY2005 FY2006 1, FY FY FY FY The sales of food business in FY2009 is excluded for period comparison. Copyright TransGenic Inc. All Rights Reserved. 11
13 Basic Strategies for the Year Ending March 2012 Overview of the Year Ended March 2011 Accomplished significant sales increase by concentrating operating resources to the area of specialty Knockout mouse business, reagent agency business: Accomplished sales increase and profitability due to enhanced business operation Antibody related business: Resumed custom-antibody production, but did not achieve a sales target because of the delay in the market recovery project Achieved a surplus in operating profit Basic Strategies for the Year Ending March Achieve company-wide surplus by maintaining the growth trend in sales and profit of each division 2. Promote overseas development including Chinese market 3. Antibody related business: Develop useful biomarker in collaborative research 4. Enhance business operation and streamline R&D by comprehensive business collaboration with IBL Copyright TransGenic Inc. All Rights Reserved. 12
14 Flowchart of management planning for the next fiscal year FY2009 Segment information Sales increase for the first time in 5 years Drastic cost reduction Unit:thousand yen Mouse Antibody Reagent SGA Consolidated Net Sales 232,487 55,807 94, ,734 Operating Expense 181, ,555 97, , ,772 Operating Profit 51,076 95,747 2, , ,038 FY2010 Segment information Sales and profit increase in all business segments Construction of revenue base Unit:thousand yen Mouse Antibody Reagent SGA Consolidated Net Sales 306,519 77, , ,100 Operating Expense 251,562 71, , , ,261 Operating Profit 54,956 6,291 22, , ,161 Management plan for the next fiscal year Promote profit increase in all business segments Achieve the first surplus after the listing Unit:thousand yen Mouse Antibody Reagent SGA Consolidated Net Sales 407, , , ,778 Operating Expense 277, , , , ,729 Operating Profit 130,230 40,014 41, ,381 14,049 Copyright TransGenic Inc. All Rights Reserved. 13
15 Consolidated Business Forecast for the Year Ending March 2012 Pass point on the Mid-term plan = A surplus will be achieved as an extension of the past. Unit:thousand yen FY2010 (result) FY2011 (forecast) Net sales 509, ,778 Mouse related business 306, ,582 Antibody related business 77, ,515 Reagent agency business 124, ,681 Cost of sales 271, ,955 Gross profit 237, ,823 SGA expence 370, ,774 R&D expence 55,947 50,353 Operating profit 133,161 14,049 Ordinary profit 144,288 15,612 Net profit 215,474 10,442 Copyright TransGenic Inc. All Rights Reserved. 14
16 Consolidated Business Forecast for the Year Ending March 2012 Net sales Sustain the trend of expansion and plan all-time profits Knockout mouse related business Antibody related business Reagent agency business Other business Unit:million yen 705 (forecast) Ordinary loss FY2004 FY2005 FY2006 1, FY FY FY FY FY (forecast) Expect to achieve a first surplus after 10 years of listing The sales of food business in FY2009 is excluded for period comparison Copyright TransGenic Inc. All Rights Reserved. 15
17 Ⅲ. Current Status of Research and Development Copyright TransGenic Inc. All Rights Reserved. 16
18 Topics of Research & Development for the year ended March 2011 Apr. Method for producing high-affinity antibody of GANP mouse technology was patented in Japan Assay system for cancer diagnosis using urine sample was patented in the U.S. Jun. Aug. Sep. Oct. Nov. Exchangeable Gene-trap mouse technology was patented in China Presented research results at the international convention of 23 rd Japanese Association for Animal Cell Technology, 2010 Business collaboration with GMJ Joint research agreement with Harbin Medical University Diacetylpermine as early stage cancer marker was patented in Japan Exclusive license agreement with Liaoning MEDI biotechnology Dec. License agreement for tumor marker(actn4)antibody with Abnova Corporation Exchangeable Gene-trap mouse technology was patented in Hong Kong Joint research agreement with Kumamoto University Feb. Joint patent application with Hiroshima University for high level protein expression technology Exchangeable Gene-trap mouse technology was patented in Japan License agreement for GANP mouse technology with GeneScript Mar. License agreement for GANP mouse technology with Immuno-Biological Research Comprehensive business collaboration with Immuno-Biological Research Copyright TransGenic Inc. All Rights Reserved. 17
19 Our Intellectual Property Status of the Patents Exchangeable Gene-trap Mouse Technology AU Patented in Australia US7,312,075 Patented in the U.S. EP Patented in Europe ZL Patented in China HK B Patented in Hong Kong JP Patented in Japan GANP Mouse Technology ZL Patented in China AU Patented in Australia EP Patented in Europe JP , JP Patented in Japan KR Patented in Korea JP Patented in Japan US7,919,674 Patented in the U.S. Apr Dec Mar Jun Dec Feb Jul Feb Apr Jan., Apr Mar Apr Apr Cancer marker in urine:assay system for cancer diagnosis using urine sample JP Patented in Japan US7,700,741 Patented in the U.S. JP Patented in Japan (diagnosis of early stage cancer) Pancreatic cancer marker:antibody and its diagnosis application Jun Apr Nov JP Patented in Japan Jun Copyright TransGenic Inc. All Rights Reserved. 18
20 Overview of Research & Development Pipeline Status of the Pipeline Approx. 3 years Approx. 2 years Identification of target Antibody production Utility verification Assay system establishment Licensing & Clinical development Market launch Short term Mid term Development of antibody product Cancer marker in urine Pancreatic cancer marker Urinary organ cancer marker Kyushu University etc. National Cancer Center Juntendo University In-license and develop from outside research institute *Licensing to Chinese company *Collaboration with IBL In progress to launch (diagnostic company) Negotiating candidate licensee Accumulating additional data Assay kit on sale Bile duct cancer marker Kumamoto University Usability under consideration Lung cancer marker Kumamoto University Usability under consideration H1N1 influenza International Medical Center of Japan Established antibodies. Suspended due to the focus of business. Copyright TransGenic Inc. All Rights Reserved. 19
21 Research & Development Pipeline Tumor Markers for Pancreatic cancers Development Pipeline - Tumor Markers in Urine Colon cancer Breast cancer DiAcSpm CEA CA19-9 Stage 0 13/21 (62%) 2/21 (9.5%) 1/21 (4.8%) Stage I 24/40 (60%) 4/40 (10%) 3/40 (7.5%) Stage II 42/60 (70%) 25/60 (42%) 3/60 (5.0%) Stage III 92/113 (81%) 53/113 (47%) 24/113 (21%) Stage IV 14/16 (88%) 10/16 (63%) 5/16 (30%) DiAcSpm CEA CA15-3 Stage I 3/15 (20%) 0/15 (0%) 0/15 (0%) Stage II 6/17 (35%) 1/17 (6%) 0/17 (0%) Stage III 3/4 (75%) 2/4 (50%) 2/4 (50%) Stage IV 38/47 (81%) 28/47 (60%) 29/47 (62%) Copyright TransGenic Inc. All Rights Reserved. 20
22 Research & Development Pipeline Tumor Markers for Pancreatic cancers Development Pipeline - Pancreatic Tumor marker Outline and progress of research Produced antibodies by GANP mouse technology against new pancreatic tumor marker identified by National Cancer Center, and established a new measuring procedure for pancreatic tumor marker. Antibody production Produced antibodies by GANP mouse technology Completed Utility verification Verified by Western blot analysis using clinical samples Completed June 2009 Patented in Japan Assay system establishment Reviewed Competitive ELISA and Sandwich ELISA Completed Utility evaluation Clinical development Accumulating data for diagnostic company Negotiating candidate licensee In progress Future plan Based on the collaborative development with IBL, optimize kit products for potential out-licensing Copyright TransGenic Inc. All Rights Reserved. 21
23 Research & Development Pipeline Tumor Markers for Pancreatic cancers Establishment of Assay system: Pancreatic cancer marker Establishment of Sandwich ELISA method Established Sandwich ELISA method by using two antibodies, produced with GANP mouse to recognize HP-FGA(the common site of proline-hydroxide modification site and FGA) Normal healthy person P P P Normal protein Pancreatoc cancer patient P-OH P-OH Abs490nm Calibration curve of Sandwich ELISA method using each antibodies G4 49D2 5B7 Modified protein HP-FGA (ng/ml) Copyright TransGenic Inc. All Rights Reserved. 22
24 Research & Development Pipeline Tumor Markers for Pancreatic cancers Development Pipeline - ACTININ-4 ACTN4 :actin-binding protein, concerned with bundle of actin overexpression Bind with beta-catenin White arrow P:primary tumor (transplant site) Blue arrow:mesenteric lymph nodes metastases Inhibit the binding to adhesion molecule cadherin Accelerate cell motility Accelerate metastasis Poor prognosis Overexpression of actinin-4 gene in colon cancer cell line enhances cell motility, and transplanting the cell to ileocecal area of mouse results in metastasis to a regional lymph node of mesenterium. Honda et al. Copyright TransGenic Inc. All Rights Reserved. 23
25 ~ For healthy and affluent lives of people around the world ~
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