financial result fy20102.sales increased by 30% due to the expanded product lines and strengthened...

25
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. Financial Results for FY 2010 ended March 2011 May 24, 2011 TRANS GENIC INC. For healthy and affluent lives of people around the worldhttp://www.transgenic.co.jp

Upload: others

Post on 03-Jul-2020

0 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Financial result FY20102.Sales increased by 30% due to the expanded product lines and strengthened sales. Unit: Thousand Yen FY2009 FY2010 Change Rate of Change Net Sales 94,439

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.

Financial Results

for FY 2010 ended March 2011

May 24, 2011TRANS GENIC INC.

~For healthy and affluent lives of people around the world~

http://www.transgenic.co.jp

Page 2: Financial result FY20102.Sales increased by 30% due to the expanded product lines and strengthened sales. Unit: Thousand Yen FY2009 FY2010 Change Rate of Change Net Sales 94,439

Copyright© TransGenic Inc. All Rights Reserved.

Table of Contents

Ⅰ. Overview of Financial Results for the Year Ended March 2011

1. 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 2012

1. 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

1

Page 3: Financial result FY20102.Sales increased by 30% due to the expanded product lines and strengthened sales. Unit: Thousand Yen FY2009 FY2010 Change Rate of Change Net Sales 94,439

Copyright© TransGenic Inc. All Rights Reserved. 2

Ⅰ. Overview of Consolidated

Financial Results

for the Year Ended March 2011

Page 4: Financial result FY20102.Sales increased by 30% due to the expanded product lines and strengthened sales. Unit: Thousand Yen FY2009 FY2010 Change Rate of Change Net Sales 94,439

Copyright© TransGenic Inc. All Rights Reserved. 3

Overview of Consolidated Financial Results

Consolidated Financial Results Highlight

Unit:thousand yenFY2009 FY2010 Change FY2010

TG,PRMNet Sales 603,985 509,100 ▲94,885 382,734

Mouse Related Business 232,487 306,519 74,031 232,487Antibody Related Business 55,807 77,750 21,942 55,807

Reagent Agency Business 94,439 124,830 30,391 94,439

Functional Food Business 221,251 - ▲221,251 -

Cost of Sales 373,210 271,666 ▲101,543 187,724Gross Profit on Sales 230,775 237,433 6,658 195,011SG&A Expenses 615,977 370,595 ▲245,381 494,048

R&D Expense 143,287 55,947 ▲87,339 143,266Operating Deficit ▲385,201 ▲133,161 252,039 ▲299,037Ordinary Loss ▲389,603 ▲144,288 245,314 ▲277,080Net Deficit ▲579,034 ▲215,474 363,560 ▲271,769

※Reference

Superficially decreased in revenue, achieved drastic increase in salespractically for 2 consecutive terms, and improved profit and loss

Page 5: Financial result FY20102.Sales increased by 30% due to the expanded product lines and strengthened sales. Unit: Thousand Yen FY2009 FY2010 Change Rate of Change Net Sales 94,439

Copyright© TransGenic Inc. All Rights Reserved. 4

Overview of Consolidated Financial Results

Overview of Business Performance by Categories

Business Performance for FY2009

Business Performance for FY2010Unit:Thousand yen Mouse Antibody Reagent SGA Consolidated

Net Sales 306,519 77,750 124,830 0 509,100Operating Expense 251,562 71,458 101,974 217,266 642,261Operating Profit 54,956 6,291 22,855 ▲217,266 ▲133,161

Increased in Sales and

Profit

Increased in Sales, Turned into the black

Increased in Sales, Turned into the black

Reduced

Unit:Thousand yen Mouse Antibody Reagent Food SGA Consolidated

Net sales 232,487 55,807 94,439 221,251 0 603,985Operating Expense 181,411 151,555 97,182 283,268 275,769 989,187Operating Profit 51,076 ▲95,747 ▲2,743 ▲ 62,017 ▲275,769 ▲385,201※ Since business categories are changed in FY2010, the numbers of FY2009 are recalculated according to the new categories.

Increased in sales and profit in all business segments, ended in the black, reduced further in operating cost

Page 6: Financial result FY20102.Sales increased by 30% due to the expanded product lines and strengthened sales. Unit: Thousand Yen FY2009 FY2010 Change Rate of Change Net Sales 94,439

Copyright© TransGenic Inc. All Rights Reserved. 5

Overview of Business Performance -Mouse Related Business

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.

Sales Growth,Increased in sales and profit for 3 consecutive terms

Unit: Thousand Yen FY2009 FY2010 ChangeRate of Change

Net Sales 232,487 306,519 74,031 31.8%Cost of Sales 130,409 190,179 59,769 45.8%Gross Operating Profit

102,077(43.9%)

116,340(38.0%)

14,262 14.0%

R&D Expense 13,492 19,750 6,258 46.4%SGA Expense 37,509 41,632 4,123 11.0%Operating Profit 51,076 54,956 3,880 7.6%※ Since business categories are changed in FY2010, the numbers of FY2009 are recalculated according to the new categories.

Page 7: Financial result FY20102.Sales increased by 30% due to the expanded product lines and strengthened sales. Unit: Thousand Yen FY2009 FY2010 Change Rate of Change Net Sales 94,439

Copyright© TransGenic Inc. All Rights Reserved. 6

Overview of Business Performance -Antibody Related Business

Sales Growth, Operating profit turned into black

Unit: Thousand Yen FY2009 FY2010 ChangeRate of Change

Net Sales 55,807 77,750 21,942 39.3%Cost of Sales 5,071 24,738 19,666 387.8%Gross Operating Profit

50,735(90.9%)

53,012(68.2%)

2,276 4.5%

R&D Expense 125,295 36,197 ▲89,097 ▲71.1%SGA Expense 21,188 10,523 ▲10,665 ▲50.3%Operating Profit ▲95,747 6,291 102,039 -※ 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 self-development to collaborative research) brought reduction in R & D expenses to achieve a budget surplus.

Page 8: Financial result FY20102.Sales increased by 30% due to the expanded product lines and strengthened sales. Unit: Thousand Yen FY2009 FY2010 Change Rate of Change Net Sales 94,439

Copyright© TransGenic Inc. All Rights Reserved. 7

Overview of Business Performance -Reagent Agency Business

Sales Growth, Operating profit turned into black

※ 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。

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.

Unit: Thousand Yen FY2009 FY2010 ChangeRate of Change

Net Sales 94,439 124,830 30,391 32.2%Cost of Sales 52,242 56,749 4,506 8.6%Gross Operating Profit

42,196(44.7%)

68,081(54.5%)

25,884(64.8%)

61.3%

R&D Expense 4,479 0 ▲4,479 ▲100.0%SGA Expense 40,460 45,225 4,764 11.8%Operating Profit ▲2,743 22,855 25,599 -

Page 9: Financial result FY20102.Sales increased by 30% due to the expanded product lines and strengthened sales. Unit: Thousand Yen FY2009 FY2010 Change Rate of Change Net Sales 94,439

Copyright© TransGenic Inc. All Rights Reserved. 8

Ⅱ. Business Topic

Page 10: Financial result FY20102.Sales increased by 30% due to the expanded product lines and strengthened sales. Unit: Thousand Yen FY2009 FY2010 Change Rate of Change Net Sales 94,439

Copyright© TransGenic Inc. All Rights Reserved. 9

Comprehensive Business Collaboration with Immuno-Biological Laboratories Co., Ltd. (IBL)

TRANS GENIC IBL

Existing business

Antibody related business, Reagent agency business

• GANP® technology• Network with pharmaceutical companies and

public research organization• New cancer markerLaboratory animal related business• Gene-Trapping technology・TG Resource

Bank®・contract service

Research related business• Antibody product, kit product specialized for

Alzheimer disease・cancer/inflammation・metabolism

• 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

• Commercialize existing research technique efficiently

• Utilize IBL’s accumulated sales network

• Develop by using GANP® technology, advance the added value of service

• Innovate and commercialize the promising seeds

• Utilize laboratory animal business for TRANS GENIC

- Combine both strength and synergize the business -

Lisencing-in GANP technology launched on March 11, 2011

Co-development of pancreatic cancer marker launched on April 25, 2011

Though business segments are similar, each has its own characteristic and no overlap or competion

Page 11: Financial result FY20102.Sales increased by 30% due to the expanded product lines and strengthened sales. Unit: Thousand Yen FY2009 FY2010 Change Rate of Change Net Sales 94,439

Copyright© TransGenic Inc. All Rights Reserved. 10

Ⅲ. Basic Strategies and

Consolidated Business Forecast

for the Year Ending March 2012

Page 12: Financial result FY20102.Sales increased by 30% due to the expanded product lines and strengthened sales. Unit: Thousand Yen FY2009 FY2010 Change Rate of Change Net Sales 94,439

Copyright© TransGenic Inc. All Rights Reserved.

Transition of Profit and loss for the past 7 years

11

1.FY2008:Decreased in net sales, improved ordinary loss2.FY2009:Increased sales and reduced cost to go into the black3.FY2010:Established the revenue base to accomplish a surplus in a short period4.FY2011:Strengthening the revenue base to achieve a surplus

Unit:million yen

Ordinary loss

Net sales

449 190

1,343 928 682

FY2004 consolidated

FY2005consolidated

FY2006 consolidated

470

279 384

640

51 435

319

13 332

FY2007 consolidated

659

324

FY2008consolidated

190

324

605

Sales of contract with two pharmaceutical companies

Sales excluding above

FY2009consolidated

299

382

382

Transition of net sales and ordinary loss

509

0

509

FY2010consolidated

144

※The sales of food business in FY2009 is excluded for period comparison.

Page 13: Financial result FY20102.Sales increased by 30% due to the expanded product lines and strengthened sales. Unit: Thousand Yen FY2009 FY2010 Change Rate of Change Net Sales 94,439

Copyright© TransGenic Inc. All Rights Reserved.

Basic Strategies for the Year Ending March 2012

12

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 operationAntibody 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

1. Achieve company-wide surplus by maintaining the growth trend in sales and profit of each division

2. Promote overseas development including Chinese market3. Antibody related business: Develop useful biomarker in collaborative research4. Enhance business operation and streamline R&D by comprehensive business

collaboration with IBL

Overview of the Year Ended March 2011

Basic Strategies for the Year Ending March 2012

Page 14: Financial result FY20102.Sales increased by 30% due to the expanded product lines and strengthened sales. Unit: Thousand Yen FY2009 FY2010 Change Rate of Change Net Sales 94,439

Copyright© TransGenic Inc. All Rights Reserved.

Flowchart of management planning for the next fiscal year

13

FY2009 Segment information

Unit:thousand yen Mouse Antibody Reagent SGA Consolidated

Net Sales 232,487 55,807 94,439 0 382,734

Operating Expense 181,411 151,555 97,182 251,623 681,772

Operating Profit 51,076 ▲95,747 ▲2,743 ▲251,623 ▲299,038

FY2010 Segment information

Unit:thousand yen Mouse Antibody Reagent SGA Consolidated

Net Sales 306,519 77,750 124,830 0 509,100

Operating Expense 251,562 71,458 101,974 217,266 642,261

Operating Profit 54,956 6,291 22,855 ▲217,266 ▲133,161

Management plan for the next fiscal year

Unit:thousand yen Mouse Antibody Reagent SGA Consolidated

Net Sales 407,582 150,515 147,681 0 705,778

Operating Expense 277,352 110,501 106,495 197,381 691,729

Operating Profit 130,230 40,014 41,186 ▲197,381 14,049

Sales increase for the first time in 5 years Drastic cost reduction

Sales and profit increase in all business segmentsConstruction of revenue base

Promote profit increase in all business segmentsAchieve the first surplus after the listing

Page 15: Financial result FY20102.Sales increased by 30% due to the expanded product lines and strengthened sales. Unit: Thousand Yen FY2009 FY2010 Change Rate of Change Net Sales 94,439

Copyright© TransGenic Inc. All Rights Reserved. 14

Consolidated Business Forecast for the Year Ending March 2012

Unit:thousand yenFY2010(result)

FY2011(forecast)

Net sales 509,100 705,778Mouse related business 306,519 407,582Antibody related business 77,750 150,515Reagent agency business 124,830 147,681

Cost of sales 271,666 336,955

Gross profit 237,433 368,823

SGA expence 370,595 354,774

R&D expence 55,947 50,353Operating profit ▲133,161 14,049Ordinary profit ▲144,288 15,612Net profit ▲215,474 10,442

Pass point on the Mid-term plan = A surplus will be achieved as an extension of the past.

Page 16: Financial result FY20102.Sales increased by 30% due to the expanded product lines and strengthened sales. Unit: Thousand Yen FY2009 FY2010 Change Rate of Change Net Sales 94,439

Copyright© TransGenic Inc. All Rights Reserved. 15

Consolidated Business Forecast for the Year Ending March 2012

Unit:million yen

573

401

▲1,343 ▲928 ▲682

47068

75

640

284

435332

▲659 ▲605

66

324

Ord

inary lo

ssN

et sale

s

39

36 65

208

25

33 80

145

67

31

Sustain the trend of expansion and plan all-time profits

Expect to achieve a first surplus

after 10 years of listing

▲299

FY2009 consolidated

55

232

94

Other businessReagent agency businessAntibody related businessKnockout mouse related business

382

15(forecast)

407

150

147

FY2011 consolidated

77

306

124

509

▲144

705(forecast)

※ The sales of food business in FY2009 is excluded for period comparison

FY2010 consolidated

FY2008 consolidated

FY2007 consolidated

FY2006 consolidated

FY2004 consolidated FY2005

Page 17: Financial result FY20102.Sales increased by 30% due to the expanded product lines and strengthened sales. Unit: Thousand Yen FY2009 FY2010 Change Rate of Change Net Sales 94,439

Copyright© TransGenic Inc. All Rights Reserved. 16

Ⅲ. Current Status of

Research and Development

Page 18: Financial result FY20102.Sales increased by 30% due to the expanded product lines and strengthened sales. Unit: Thousand Yen FY2009 FY2010 Change Rate of Change Net Sales 94,439

Copyright© TransGenic Inc. All Rights Reserved. 17

Topics of Research & Development for the year ended March 2011

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

Feb.

License agreement for GANP® mouse technology with Immuno-Biological ResearchMar.

“Assay system for cancer diagnosis using urine sample” was patented in the U.S.

“Exchangeable Gene-trap mouse technology” was patented in China

“Method for producing high-affinity antibody of GANP®mouse technology” was patented in Japan

Business collaboration with GMJ

Apr.

Jun.

Sep.

Joint research agreement with Harbin Medical UniversityOct.

Presented research results at the international convention of 23rd Japanese Association for Animal Cell Technology, 2010Aug.

Nov. “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

Comprehensive business collaboration with Immuno-Biological Research

Page 19: Financial result FY20102.Sales increased by 30% due to the expanded product lines and strengthened sales. Unit: Thousand Yen FY2009 FY2010 Change Rate of Change Net Sales 94,439

Copyright© TransGenic Inc. All Rights Reserved.

Our Intellectual PropertyStatus of the Patents

“JP3816512” Patented in Japan“US7,700,741” Patented in the U.S.“JP4608432” Patented in Japan (diagnosis of early stage cancer)

Jun. 2006Apr. 2010Nov. 2010

“JP4319700” Patented in Japan Jun. 2009

Cancer marker in urine:Assay system for cancer diagnosis using urine sample

Pancreatic cancer marker:Antibody and its diagnosis application

“AU778719” Patented in Australia“US7,312,075” Patented in the U.S.“EP1201759” Patented in Europe“ZL00812904.5” Patented in China“HK1048830B” Patented in Hong Kong“JP4664554” Patented in Japan

Apr. 2005Dec. 2007Mar. 2010Jun. 2010Dec. 2010Feb. 2011

Exchangeable Gene-trap Mouse Technology

“ZL2003801028324” Patented in China“AU2003277620” Patented in Australia“EP1559318” Patented in Europe“JP4426728”, “JP4478577” Patented in Japan“KR941905” Patented in Korea“JP4478577” Patented in Japan“US7,919,674” Patented in the U.S.

Jul. 2008Feb. 2009Apr. 2009

Jan., Apr. 2010Mar. 2010Apr. 2010Apr. 2011

GANP® Mouse Technology

18

Page 20: Financial result FY20102.Sales increased by 30% due to the expanded product lines and strengthened sales. Unit: Thousand Yen FY2009 FY2010 Change Rate of Change Net Sales 94,439

Copyright© TransGenic Inc. All Rights Reserved. 19

Identificationof target

Antibodyproduction

Utilityverification

Assay systemestablishment

Licensing &Clinical

developmentMarket launch

Approx. 3 years Approx. 2 years

Cancer marker in urine

Kyushu University etc.

Pancreatic cancer marker

National CancerCenter

Urinary organ cancer marker

JuntendoUniversity

Bile duct cancer marker

Kumamoto University

Lung cancer marker Kumamoto University

H1N1 influenzaInternational Medical Center of Japan

Development of antibody product

In-license and develop from outside research institute

Mid term

Short term

In progress to launch(diagnostic company)

Negotiating candidate licensee Accumulating additional data

Assay kit on sale

Usability under consideration

Usability under consideration

Established antibodies. Suspended due to the focus of business.

Overview of Research & Development PipelineStatus of the Pipeline

*Collaboration with IBL

*Licensing to Chinese company

Page 21: Financial result FY20102.Sales increased by 30% due to the expanded product lines and strengthened sales. Unit: Thousand Yen FY2009 FY2010 Change Rate of Change Net Sales 94,439

Copyright© TransGenic Inc. All Rights Reserved. 20

Research & Development Pipeline – Tumor Markers for Pancreatic cancersDevelopment Pipeline - Tumor Markers in Urine

DiAcSpm CEA CA19-9Stage 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 CA15-3Stage 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%)

Colon cancer

Breast cancer

Page 22: Financial result FY20102.Sales increased by 30% due to the expanded product lines and strengthened sales. Unit: Thousand Yen FY2009 FY2010 Change Rate of Change Net Sales 94,439

Copyright© TransGenic Inc. All Rights Reserved. 21

Research & Development Pipeline – Tumor Markers for Pancreatic cancersDevelopment 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.

Based on the collaborative development with IBL, optimize kit products for potential out-licensing

Verified by Western blot analysis using clinical samples

Produced antibodies by GANP®mouse technology Completed

CompletedJune 2009

Patented in Japan

Reviewed Competitive ELISA and Sandwich ELISA Completed Utility

evaluation

Accumulating data for diagnostic companyNegotiating candidate licensee

In progress

Future plan

Antibody production

Utilityverification

Assay systemestablishment

Clinical development

Page 23: Financial result FY20102.Sales increased by 30% due to the expanded product lines and strengthened sales. Unit: Thousand Yen FY2009 FY2010 Change Rate of Change Net Sales 94,439

Copyright© TransGenic Inc. All Rights Reserved. 22

Research & Development Pipeline – Tumor Markers for Pancreatic cancersEstablishment of Assay system: Pancreatic cancer marker

◆Establishment of Sandwich ELISA methodEstablished 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

Normal protein

PP P

P-OH P-OH

Pancreatoc cancer patient

Modified protein

 Calibration curve of Sandwich ELISA method usingeach antibodies

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

4.0

4.5

0 100 200 300 400

HP-FGA (ng/mL)

Abs

490nm

14G4

49D2

5B7

Page 24: Financial result FY20102.Sales increased by 30% due to the expanded product lines and strengthened sales. Unit: Thousand Yen FY2009 FY2010 Change Rate of Change Net Sales 94,439

Copyright© TransGenic Inc. All Rights Reserved. 23

Research & Development Pipeline – Tumor Markers for Pancreatic cancersDevelopment Pipeline - ACTININ-4

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.

White arrow P:primary tumor(transplant site)Blue arrow:mesenteric lymph nodes metastases

ACTN4 :actin-binding protein, concerned with bundle of actin

overexpression

Bind with beta-catenin

Inhibit the binding to adhesion molecule cadherin

Accelerate cell motility

Accelerate metastasis

Poor prognosis

Honda et al.

Page 25: Financial result FY20102.Sales increased by 30% due to the expanded product lines and strengthened sales. Unit: Thousand Yen FY2009 FY2010 Change Rate of Change Net Sales 94,439

~ For healthy and affluent lives of people around the world ~

http://www.transgenic.co.jp