MIRA INFORM REPORT

 

 

 

Report Date :

05.08.2008

 

IDENTIFICATION DETAILS

 

Name :

BIOCON LIMITED

 

 

Registered Office :

20th KM, Hosur Main Road, Electronics City, Bangalore – 560100, Karnataka

 

 

Country :

India

 

 

Financials (as on) :

31.03.2008

 

 

Date of Incorporation :

20.11.1978

 

 

Com. Reg. No.:

08-3417

 

 

CIN No.:

[Company Identification No.]

U00309KA1978PLC003417

 

 

TAN No.:

[Tax Deduction & Collection Account No.]

BLRB00214E

 

 

Legal Form :

Subject is a public limited liability company. The company’s shares are listed on the stock exchanges.

 

 

Line of Business :

Manufacturers, Exporters and Importers of all kinds of Enzymes, Oleoresins, Catalytic Preparations, Organic Chemicals and Organic and Bio-Chemicals, etc.

 

RATING & COMMENTS

 

MIRA’s Rating :

Aa

 

RATING

STATUS

PROPOSED CREDIT LINE

71-85

Aa

Possesses adequate working capital. No caution needed for credit transaction. It has above average (strong) capability for payment of interest and principal sums

Large

 

 

 

 

 

Maximum Credit Limit :

USD 66000000

 

 

Status :

Very Good

 

 

Payment Behaviour :

Regular

 

 

Litigation :

Clear

 

 

Comments :

Subject is a well established company engaged in manufacturing and marketing of Biochemical’s, Enzymes and Pharmaceuticals. The company’s track are fine and is making very good progress in its turnover and profits. It has also plans to expand further.

 

The company’s trade relations are reported as fair. Payments are usually correct and as per commitments.

 

The company can be considered good for normal business dealings.

 

LOCATIONS

 

Registered Office/ Factory :

20th KM, Hosur Main Road, Electronics City, Bangalore – 560100, Karnataka, India

Tel. No.:

91-80-28422169/28523434/ 28082808

Fax No.:

91-80-28422623/25531662/28523423

E-Mail :

info@biocon.com

contact.us@bioconindia.com

contact.us@biocon.com

usha.tn@biocon.com

Website :

http://www.biocon.com

Area :

15000 sq. ft.

Locations :

Owned

 

 

Factory 1 :

Plot No 113/C2, Bommasandra Industrial Area, Bommasandra, Bangalore – 560099, Karnataka, India

 

 

Factory 2 :

Plot No 2,3,4 and 5, Bommasandra – Jigani Link Road, Bangalore - 560099, Karnataka, India

 

 

Overseas office:

1406, Woodbridge, Commons Iselin, NJ   08830, USA

Tel. No.:

91-732 636 2950

Fax No.:

91-732 636 2951

 

 

Branch office :

Located at:-

 

  • 210 A, Gokul Arcade, Sahar Road, Garware Chowk, Vile Parle (E), Mumbai - 400 057, Maharashtra

Tel. No. 91-22-56919760/61/62

 

  • No.15, Narmada Apartments, Alaknanda, New Delhi - 110 019

Tel. No. 91-11-26449819

 

  • No. 49/1, Rastra Guru Avenue, Nagar Bazar, Dum Dum, Kolkata - 700 028, West Bengal

Tel. No. 91-33-25501299

 

DIRECTORS

 

Name :

Mrs. Kiran Mazumdar

Designation :

Chairperson and  Managing Director

Address :

874/1, 7th Cross III Block, Koramangala, Bangalore - 560 034, Karnataka, India

Date of Birth/Age :

20.11.1978

Qualification :

B.Sc. (Hons.), PG Diploma in Malting & Brewing

Date Of Appointment :

01.12.1978

Previous Employment:

Jupiter Breweries, Kolkata, West Bengal (Consultants)

 

 

Name :

Mr. J. M. M. Shaw

Designation :

Whole- time Director

Address :

874/1, 7th Cross III Block, Koramangala, Bangalore - 560 034, Karnataka, India

Date of Birth/Age :

12/04/1949

Date of Appointment :

29/09/1998

 

 

Name :

Dr. Neville Bain

Designation :

Director

Address :

High Trees, Cavendish Road, Waybridge, Surrey KT 13, OJX, UK

Date of Birth/Age :

17/04/1955

Date of Appointment :

08/08/2000

 

 

Name :

Prof. Ravi Mazumdar

Designation :

Director

Address :

706, Carrolton Boulevard, West Lafayeete, IN - 47906, USA

Date of Birth/Age :

14/07/1940

Date of Appointment :

08/08/2000

 

 

Name :

Prof. Charles L. Cooney

Designation :

Director

Address :

14/09/1961

Date of Birth/Age :

35, Chestnut Palace, Brookline MA , USA

Date of Appointment :

27/07/2001

 

 

Name :

Dr. Bala Manian

Designation :

Mr. Catherine Rosenberg

 

 

Name :

Mr. Suresh Talwar

Designation :

Director

 

 

Name :

Prof Catherine Rosenberg

Designation :

Alternate Director

 

 

Name :

Mr. John Shaw

Designation :

Director

 

 

Name :

Mr. Anthony Allison

Designation :

Director

 

KEY EXECUTIVES

 

Name :

Mr. Ajay Bhardwaj

Designation :

President – Group Marketing

Date of Birth/Age :

46 Years

Qualification :

M. S. [Chemical Engineering]

Experience :

22 Years

Date of Appointment :

01.01.1986

Last Employment :

Project Engineer Max India Limited, New Delhi

 

 

Name :

Dr. Chaitanya R. Divgi

Designation :

Chief Executive

 

 

Name :

Mr. J M M Shaw

Designation :

Vice Chairman

Qualification :

M. A [Hons]

Date of Appointment :

01.04.1999

Last Employment :

President – Berghaus International Fashion Group, Holland 

 

 

Name :

Prof. Hans Wigzell

Designation :

Head [Centre for Medical Innovations]

 

 

Name :

Dr. Arun Chandavarkar

Designation :

President (Operations and Technology)

Qualification :

Ph. D. [Chemical Engineering]

Date of Appointment :

08.11.1990

 

 

Name :

Mr. Murali Krishnan

Designation :

President (Finance)

Qualification :

B. Com. CA

Experience :

24 Years

Date of Appointment :

09.11.1981

 

 

Name :

Mr. Rakesh Bamzai

Designation :

Vice President, Marketing

Date of Birth/Age :

45 Years

Qualification :

B. Sc. [Food and Fermentation Tech]

Experience :

17 Years

Date of Appointment :

19.04.1995

Last Employment :

Assistant General Manager – Marketing

Advanced Biochemical’s Limited

 

 

Name :

Mr. Chinappa M. B.

Designation :

Vice President, Finance

Qualification :

B. Com. ACA

Date of Appointment :

12.07.1999

Last Employment :

Finance Manager ITC Limited, Calcutta

 

 

Name :

Mr. Shrikumar Suryanarayan

Designation :

President (Research & Development)

Qualification :

M. Tech [Chemicals Engineering]

Date of Appointment :

02.05.1984

 

 

Name :

Dr. Goutam Das

Designation :

Chief Operating Officer, Syngene

 

 

Name :

Mr. A. S. Arvind

Designation :

Chief Operating Officer, Clinigene

 

 

Name :

Dr. Sambasivam Ganesh

Designation :

Chief Scientific Officer 

 

 

Name :

Dr. Subir Kumar Basak

Designation :

General Manager, Business Development

 

 

Name :

Mr. Ravindra K. C.

Designation :

General Manager, production

 

 

Name :

Dr. Harish V. Iyer

Designation :

General Manager, Research and Development 

 

 

Name :

Dr. Tara Jayaram

Designation :

General Manager, Quality Assurance

 

 

Name :

Mr. Ramalingeswara Rao K.

Designation :

General Manager, Marketing

 

 

Name :

Mr. Akash S. Puranik

Designation :

General Manager, Marketing

 

 

Name :

Mr. Sandeep Rao

Designation :

General Manager, Marketing

Date of Birth/Age :

32 Years

Qualification :

M. Sc. PGDM

Experience :

7 Years

Date of Appointment :

15.06.1999

 

 

Name :

Mr. Gautam Reddy

Designation :

General Manager, Group HR

 

 

Name :

Mr. Sundaresh S. R.

Designation :

General Manager, Commercial

 

 

Name :

Mr. Anindya Sircar

Designation :

General Manager, IPR

 

 

Name :

Mr. Prasad B. S. V.

Designation :

General Manager, Productions

 

MAJOR SHAREHOLDERS / SHAREHOLDING PATTERN

 

(As on 30.06.2008)

Names of Shareholders

No. of Shares

Percentage of Holding

Shareholding of Promoter and Promoter Group

 

 

Indian

 

 

Individuals / Hindu Undivided Family

40440112

40.44

Foreign

 

 

Individuals (Non-Resident individuals / Foreign Individuals)

703779

0.7

Bodies Corporate

19767597

19.77

Public shareholding

 

 

Institutional

 

 

Mutual Funds / Axis

9453627

9.45

Financial Institutions /Banks

48737

0.05

Insurance Companies

804335

0.8

Foreign Institutional Investors

6371601

6.37

Non-institutional

 

 

Bodies Corporate

1931208

1.93

Individuals

 

 

Individual shareholders holding nominal share capital up to Rs 0.100 Million

7815490

7.82

Individual shareholders holding nominal share capital in excess of Rs 0.100 Million

6406200

6.41

Any Other-

 

 

Non resident Indians

506820

0.51

Clearing Members

356445

0.36

Foreign Nationals

71510

0.07

Foreign Bodies

52687

0.05

Trusts

5269852

5.27

Total

100000000

100.00

 

BUSINESS DETAILS

 

Line of Business :

Manufacturers, Exporters and Importers of all kinds of Enzymes, Oleoresins, Catalytic Preparations, Organic Chemicals and Organic and Bio-Chemicals, etc.

 

 

Products :

Products Description

 

ITC Code

Enzymes for Pharmaceutical Use

350790

Organic and Inorganic Chemicals

280000 & 290000

 

  • Biopharmaceuticals
  • Enzymes

 

 

Brand Names :

"BIOCON"

 

 

PRODUCTION STATUS

 

Particulars

Unit

 

 

Actual Production

Enzymes

Kg.

 

 

4576302

Pharmaceuticals

Kg.

 

 

9689578

 

 

GENERAL INFORMATION

 

No. of Employees :

2772

 

 

Bankers :

·         State Bank of India,

Overseas Branch, M. G. Road, Bangalore, Karnataka

 

  • Hongkong Bank,

Manipal Centre, Dickenson Road, Bangalore - 560 042,     Karnataka

Tel. No. 91-80-5585444

Fax No. 91-80-5584411

 

  • Canara Bank,

Vasanthanagar Branch, Bangalore - 560052, Karnataka, India

 

 

Facilities :

Secured Loan

Rs in Millions

31.03.2008

 

 

From banks

Cash credit, packing credit, etc

892.634

 

 

Cash credit, packing credit, etc

 

The Company has rupee and foreign currency denominated fund based working capital facilities with State Bank of India (SBI) .These facilities are repayable on demand, secured by a pari-passu first charge on current assets. As on March 31, 2008 the Company has utilized Rs.443.148 Millions

 

The Company has fund and non fund based working capital facilities with Hongkong and Shanghai Banking Corporation (HSBC). These facilities are repayable on demand, secured by pari-passu first charge on current assets of the Company. As on March 31, 2008 the Company has utilised fund based limits of Rs.242.738 Millions

 

(iii) The Company has working capital facilities with Canara Bank (‘CB’). These facilities are repayable on demand, secured by a paripassu first charge on current assets of the Company .As on March 31, 2008 the Company has utilised Rs.206.748 Millions

 

(iv) The Company has fund and non fund based working capital facility with ABN Amro Bank. These facilities are repayable on demand, secured by a pari passu second charge on the fixed assets of the Company. As on March 31, 2008 the Company has utilised Rs.Nil

 

(v) All the above banks have entered into an inter-se agreement for operational convenience for the above working capital limits effecting the modification of the above charge and creation of a pari passu charge on the current assets of the company in favour of all the above banks.

 

Unsecured loan

Rs in Millions

31.03.2008

 

 

Deferred Paymnt Liability

NMITLI – CSIR Loan

543.039

3.180

546.219

 

Under the Industrial Policy of the Government of Karnataka, the Company on November 18, 2000 obtained an order from the Karnataka Sales Tax Authority for allowing deferment of sales tax (including turnover tax) for a period upto 8 years with respect to sales from its Bommasandra manufacturing facility for an amount not exceeding Rs.24.375 Millions. As at March 31, 2008 the Company has utilized Rs.0.354 Millions

 

Under the Agro Food Processing Industrial Policy of the Government of Karnataka, the Company on November 18, 2000 obtained an order from the Karnataka Sales Tax Authority for allowing deferment of sales tax (including turnover tax) for a period upto 12 years with respect to sales from its Hebbagodi manufacturing facility for an amount not exceeding Rs.648.938 Millions. As at March 31, 2008, the Company has utilised Rs.542.685 Millions

 

On March 31, 2005, the Company entered into an agreement with the Council of Sceintifi c and Industrial Research (‘CSIR’), for an unsecured loan of Rs.3.180 Millions for carrying out part of the research and development project under the New Millenium Indian Technology Leadership Initiative (‘NMITLI’) Scheme. The loans are repayable over 10 annual equal installments starting from October 1, 2008 and carry an interest rate of 3 per cent per annum. The amount of repayment within one year is Rs.0.318 Millions.

 

 

 

Banking Relations :

Satisfactory

 

 

Auditors :

Arthur Anderson

Chartered Accountants

Address :

Bangalore, Karnataka

 

 

Associates:

  • Biocon Group

 

  • Syngene International Private Limited

Syngene International Private Limited is a 99.99% owned subsidiary of Biocon. It was incorporated on Novemvber 18, 1993. By way of a restructuring, 99.9% of the shares in Syngene held by Kiran Mazumdar Shaw, ICICI and a few other scientists were transferred to Biocon in consideration for the issue of shares by Biocon to the shareholders of Syngene on March 31, 2002. The paid-up capital of Syngene is Rs. 28.750 millions.

 

  • Clinigene International Private Limited

Clinigene International Private Limited is a 100% owned subsidiary of Biocon Limited. It was incorporated on August 4, 2000 with an authorised capital of Rs 5.000 millions. The paid-up capital of Clinigene is Rs. 0.500 million.

 

  • Biocon Biopharmaceuticals Private Limited (BBPL)

BBPL is a Joint Venture company of Biocon in collaboration with CIMAB SA, Cuba. The equity participation by Biocon is 51%. The Joint Venture agreement was entered on February 22, 2002. The paid-up capital of BBPL is Rs. 8.800 millions.

 

 

Subsidiaries/ Joint venture:

  • Ciligene International Private Limited
  • Syngene International Private Limited
  • Biocon Biopharmaceuticals Private Limited

 

 

CAPITAL STRUCTURE

 

Authorised Capital :

No. of Shares

Type

Value

Amount

 

 

 

 

120000000

Equity shares

Rs.5/- each

Rs.600.000 millions

 

 

 

 

 

Issued, Subscribed & Paid-up Capital :

No. of Shares

Type

Value

Amount

 

 

 

 

100000000

Equity shares

Rs.5/- each

Rs.500.000 millions

 

 

 

 

 

Note:

 

Of the above equity shares:

(i) 30,800 equity shares of Rs.100 each were allotted as fully paid bonus shares by capitalisation of general reserve in the year ended March 31, 1997.

(ii) 23,471 equity shares of Rs.100 each were allotted as fully paid-up shares in the year ended March 31, 2000 pursuant to a contract for consideration other than cash.

(iii) On March 30, 2002, the Company acquired 99.9 per cent equity in Syngene through the issue of 202,780 equity shares of Rs.10 each. The consideration was determined on the basis of a fair valuation, as approved by the statutory authorities in India. The related securities premium at Rs.403.8 per equity share has been credited to securities premium account.

 

On November 11, 2003, the Company issued 86,324,700 equity shares of Rs.5 each as fully paid up bonus shares by capitalisation of the balance in the profit and loss account of Rs.431.624 Millions.


 

FINANCIAL DATA

[all figures are in Rupees Millions]

 

 

ABRIDGED BALANCE SHEET

 

SOURCES OF FUNDS

 

31.03.2008

31.03.2007

31.03.2006

SHAREHOLDERS FUNDS

 

 

 

1] Share Capital

500.000

500.000

500.000

2] Share Application Money

0.000

0.000

0.000

3] Reserves & Surplus

12781.963

8916.405

7530.435

4] (Accumulated Losses)

0.000

0.000

0.000

NETWORTH

13281.963

9416.405

8030.435

LOAN FUNDS

 

 

 

1] Secured Loans

892.634

587.331

677.549

2] Unsecured Loans

546.219

480.402

372.927

TOTAL BORROWING

1438.853

1067.733

1050.476

DEFERRED TAX LIABILITIES

398.237

397.569

279.738

 

 

 

 

TOTAL

15119.053

10881.707

9360.649

 

 

 

 

APPLICATION OF FUNDS

 

 

 

 

 

 

 

FIXED ASSETS [Net Block]

6518.596

6649.894

2278.123

Capital work-in-progress

646.341

299.048

4564.301

 

 

 

 

INVESTMENT

4772.602

786.000

1390.554

Intangible Assets

276.000

512.000

0.000

 

 

 

 

CURRENT ASSETS, LOANS & ADVANCES

 

 

 

 
Inventories
1677.350
1506.589
712.922
 
Sundry Debtors
2256.629
2748.526
1728.842
 
Cash & Bank Balances
81.244
76.313
34.201
 
Other Current Assets
0.000
0.000
0.000
 
Loans & Advances
1235.457
467.779
362.845
Total Current Assets

5250.680

4799.207

3345.622
Less : CURRENT LIABILITIES & PROVISIONS

 

 

 
 
Current Liabilities
2345.166
1759.431
1818.890
 
Provisions
0.000
405.011
399.061
Total Current Liabilities

2345.166

2164.442

2217.951
Net Current Assets

2905.514

2634.765

1127.671
 

 

 

 

MISCELLANEOUS EXPENSES

0.000

0.000

0.000

 

 

 

 

TOTAL

15119.053

10881.707

9360.649

 


PROFIT & LOSS ACCOUNT

 

PARTICULARS

 

31.03.2008

31.03.2007

31.03.2006

Sales Turnover

8320.839

8237.402

6874.924

Other Income

971.165

393.457

56.911

Total Income

9292.004

8630.859

6931.835

 

 

 

 

Profit/(Loss) Before Tax

2061.975

1710.491

1608.734

Provision for Taxation

106.384

126.989

273.904

Profit/(Loss) After Tax

1955.591

1583.502

1334.830

 

 

 

 

Earnings in Foreign Currency :

 

 

 

 

Export Earnings

NA

4489.161

3577.231

 

Recovery of freight, insurance etc on exports

NA

38.757

1.504

 

Technical Licensing fees

NA

272.352

10.781

Total Earnings

NA

4800.270

3589.516

 

 

 

 

Imports :

 

 

 

 

Raw Materials

NA

2375.579

2481.980

 

Packing Materials

NA

15.051

2.164

 

Capital Goods

NA

188.097

349.095

Total Imports

NA

2578.727

2833.239

 

 

 

 

Expenditures :

 

 

 

 

Manufacturing Expenses, Contract research and other expenses

6511.351

6266.690

5077.718

 

Interest and finance charge

28.698

77.618

16.887

 

Others Expenses

689.980

576.060

228.496

Total Expenditure

7230.029

6920.368

5323.101

 

 

QUARTERLY RESULTS

 

PARTICULARS

 

 

 

30.06.2008

 Type

 

 

 1st Qtr

 Sales Turnover

 

 

2211.800

 Other Income

 

 

162.800

 Total Income

 

 

2374.600

 Total Expenditure

 

 

1858.200

 Operating Profit

 

 

516.400

 Interest

 

 

18.200

 Gross Profit

 

 

498.200

 Depreciation

 

 

176.800

 Tax

 

 

31.500

 Reported PAT

 

 

300.100

 

 

KEY RATIOS

 

PARTICULARS

 

31.03.2008

31.03.2007

31.03.2006

Debt Equity Ratio

0.11

0.12

0.12

Long Term Debt Equity Ratio

0.05

0.05

0.04

Current Ratio

1.52

1.29

0.97

TURNOVER RATIOS

 

 

 

Fixed Assets

1.04

1.51

2.48

Inventory

5.68

6.93

8.21

Debtors

3.61

3.69

3.82

Interest Cover Ratio

67.71

21.94

65.86

Operating Profit Margin (%)

30.79

26.70

25.69

Profit Before Interest and Tax Margin (%)

23.15

20.20

22.54

Cash Profit Margin (%)

26.86

24.34

21.57

Adjusted Net Profit Margin (%)

19.22

17.85

18.42

Return on Capital Employed (%)

16.62

18.34

19.47

Return on Net Worth (%)

15.32

18.18

17.84

  

 

LOCAL AGENCY FURTHER INFORMATION

 

HISTORY

 

Subject is a fully integrated healthcare company was incorporated in the year 1978 as a joint venture between Biocon Biochemicals Limited of Ireland and an Indian entrepreneur, Kiran Mazumdar-Shaw. The Company's business model spans the entire drug value chain, from pre-clinical discovery to clinical development and through to commercialisation and focused on biopharmaceuticals, custom research and clinical research. Company is an ISO 9001, ISO 14001:2004, ISO 9001:2000, ISO 15189:2003 and also OHSAS 18001:1999 certified for various levels. Company have two subsidiary companies for support, namely Syngene International Ltd and Clinigene International Limited. Companyhas rapidly developed a robust drug pipeline, led by monoclonal antibodies and several other molecules at exciting stages in the biopharmaceutical value chain.  

 
Subject manufactured and exported enzymes to USA and Europe during the year 1979, as first of its kind. In 1989, Unilever plc acquired the Biocon Biochemicals Limited in Ireland and merges it with its subsidiary, Quest International. Also in the same year, the company had received US funding for proprietary technologies. After a year, in 1990, Biocon had scaled up its in-house research programme, based on a proprietary solid substrate fermentation technology, from pilot to plant level. Biocon's R&D and manufacturing facilities received ISO 9001 certification from RWTUV, Germany during the period of 1993. In the year 1994, the company had established the Syngene International Private Limited. as a Custom research Company (CRC) to address the growing need for outsourced R&D in the pharmaceutical sector. The commercial success of Biocon's proprietary fermentation plant leads to a 3-fold expansion during the year 1996 and also in the same year, the company had leveraged its technology platform to enter biopharmaceuticals and statins. Biocon had spearheads initiatives in human healthcare in the year 1997 through a dedicated manufacturing facility.  

 
During the year 1998, Unilever inked a deal with ICI to sell its specialty chemicals division of which Quest International is a part. Unilever agreed to sell its shareholding in Biocon to the Indian promoters. Biocon becomes an independent entity in same period. In the year 2000, Biocon had commissioned its first fully automated submerged fermentation plant to produce specialty pharmaceuticals and also in the same year, the company had established Clinigene, India's first Clinical Research Organisation (CRO) to pursue clinical research and development. During the year 2001, Biocon becomes the first Indian company to be approved by US FDA for the manufacture of lovastatin, a cholesterol-lowering molecule. During the same year of 2001, the company's proprietary bioreactor, PlaFractor was granted a US 2001 and worldwide patent. Later on, in 2002, Clinigene's clinical laboratory of the company received CAP accreditation as the first in India. The Company had developed the human insulin on a Pichia expression system in the year 2003. Biocon created a buzz in the stock market in March of the year 2004 with its hugely successful IPO. Day 1 on the bourses closed with a market value of $1.11 billion, making Biocon only the second Indian company to cross the $1 billion mark on the first day of listing. During the same year 2004, the Syngene had established new research centre, launched INSUGEN, the new generation bio-insulin, manufactured in Asia's largest human insulin plant. 

 
Biocon Limited and Vaccinex, Inc, collectively announced a broad strategic partnership to discover and co-develop at least four therapeutic antibody products. Biocon had signed a commercial agreement for supply of insulin API to Asia, Africa and the Middle East during the period of 2005. During the year 2006, the company inaugurated Biocon Park, India's largest integrated biotechnology hub, comprising an integrated cluster of research laboratories and manufacturing facilities spread across 90 acres in KIADB (Karnataka Industrial Areas Development Board) industrial estate and also established Biocon Biopharmaceuticals, India's largest multi-product Biologics facility at Biocon Park. In the same year 2006, Biocon's Syngene and Innate Pharmaceuticals AB, Umea, Sweden conclude a cooperation agreement to jointly develop, manufacture and market virulence blockers to counteract bacterial diarrhoeal disease and also launched India's first anti-cancer drug BIOMAb EGFR.  
 
Abu Dhabi based pharmaceutical company Neopharma had signed an MOU with the company to establish a JV to manufacture and market a range of biopharmaceuticals for the GCC countries (Gulf Cooperation Council) in the year 2007. The Company launched its Nephrology Division and a comprehensive portfolio of renal therapy products. Syngene had entered into a research partnership with Bristol-Myers Squibb and completes the groundbreaking ceremony of new research facility at Biocon Park. During the identical year of 2007, Biocon signed Memorandum of Understanding with Deakin University, Australia to establish Deakin Research Institute in Bangalore. The Company divested its enzymes division for USD 115 million to Novozymes. Biocon and Neopharma signed an MOU in July of the year 2007 to establish Neobiocon, a joint venture company in Dubai's biotechnology and research park, Dubiotech.  

 
As at January 2008, Subject and IATRICa, Inc made a strategic partnership to co-develop an exclusive new class of immunoconjugates for targeted immunotherapy of cancers and infectious diseases. In February of the year 2008, the company had acquired 70% stake in German pharmaceutical company, AxiCorp GmbH for a consideration of? 30 Million. As at June 2008, Biocon launched a Safety Device in the form of pre-filled syringes for two of its life saving products, GCSF (granulocyte-colony stimulating factor) and EPO (Erythropoietin) in collaboration with Safety Syringes Inc.

 

 

BUSINESS

 

Subject is engaged in the business as Manufacturers, Exporters and Importers of all kinds of Enzymes, Oleoresins, Catalytic Preparations, Organic Chemicals and Organic and Bio-Chemicals, etc.

 

Subject is also engaged in to carry on the business of manufacturing, processing, distilling, compounding, formulating, acquiring, buying, selling, importing, exporting and dealing in all enzyme products from animal, microbial, plant sources, products from fish sources, vegetable and herb extracts, agricultural products including cattle feed, and all chemicals heavy or fine, organic, inorganic, biological or any other formulations, derivatives and compounds thereof from mineral origin or from other chemicals or from by-products or waste products of other trades and industries and other branded preparations and compounds, derivatives and formulations thereof and consumers products based thereon, pharmaceutical specialities, surgical specialities, cosmetics, germicides, detergents and acids.

 

The company is in trade terms with:

 

·         Anil Agro Products Private Limited

 

 

 

Results of Operations: 

 

During the year the operations excluding exceptional items reflected 10 percent growth in consolidated revenues while Operating Profits (EBITDA) and Profit after Tax grew by 17 percent and 12 percent respectively. The performance for the year reflects strong focus on operational efficiencies and aggressively defending their market position in the face of strong competition in the generic API space, monetization of some of their research programs by way of licensing and partnering and the divestment of the Enzymes business.

 

 

Business Operations overview and Outlook:

 
Significant volume growth and increased market share in the European and US Markets for Statinshelped to negate the impact of pricing pressures and the weakening US Dollar thereby maintaining Statin sales at previous year’s levels.

 

Sales of Insulin increased significantly in both the domestic and export markets. The Company entered into licensing agreements covering certain markets in Asia and has also progressed its application for registration in the European Union and several countries across Asia, Latin America and Africa. To meet the overall increased projections for Insulin, the Company has commenced an expansion of its capacities and the new facility is near completion and is expected to be commissioned later this year.

 

Immunosuppressant are also expected to offer significant growth opportunities consequent to product patent expiry in key markets of Mycophenolate Mofetil and Tacrolimus in the period 2008-2012.

 

Biocon’s foray into direct marketing of formulations continued to make impressive strides. the Nephrology Division launched ERYPROTM and ERYPROSAFETM, for treatment in renal transplant and dialysis and two Immunosuppresants – RENODAPTTM and TACROGRAFTM. Biocon’s Insugen has been widely prescribed and accepted with impressive gains in market share and BIOMAB EGFRTM has been prescribed to over a 1,000 patients since its launch in August 2006.

 

Company signed two important agreements with Abraxis Biosciences, USA to out- license G-CSF for the North American and European markets and in-license Abraxane® for India and a few markets across Asia and the GCC. These agreements are expected to generate a steady stream of revenues once the products get regulatory approval in the relevant territories.

 

Company also entered into an agreement to acquire a majority stake in AxiCorp GmbH, Germany. This strategic investment will enable Biocon to market and distribute biosimilar insulin and analogs in Europe which together with NeoBiocon, its joint venture in Dubai, thereby expanding Biocon’s global reach.

 

Company continues to invest incrementally to progress its innovation pipeline. While during the year Biocon monetized some of it’s research programs by way of licensing and partnering , it’s rich product pipeline including IN-105, BVX 10, BVX 20 and T1H are expected to contribute significantly to Biocon’s growth in the future years. The year company has completed Phase I studies of IN-105 in India and received approval for commencement of Phase II studies. Company has also initiated Phase I studies for IN 105 in Sweden and Phase II studies for T1H in India.

 


Subsidiaries and Joint Ventures: 

 
Syngene International Limited: 

 

Syngene has strong knowledge base where out of the total strength 907 employees (754 in the previous year) more than 90% employees are scientists. With the focused and collaborative efforts of its employees, Syngene has achieved greater heights during the year and has built a strong international reputation.

 

 

 

 

Clinigene International Limited: 

 

Clinigene International Limited is a wholly owned subsidiary of the Company focused on Clinical Development. For the current financial year, Clinigene earned a profit of Rs.24 million as against Rs.8 million in the previous year. The company registered revenue of 227 million as against Rs.115 million in the previous year.

 

During the year Clinigene has moved into a 65,000 sq. ft. fully functional facility at Semicon Park which houses a complete array of services including human pharmacology, clinical operations, clinical data management, bioanlytical services and a central laboratory supporting early phase to late phase clinical development programs. With demand for outsourced research growing exponentially, Clinigene is well positioned to strengthen its existing relationships and establishing new partnerships with top MNC pharma companies for clinical development requirements.


Biocon Biopharmaceuticals Private Limited: 

 

This is Biocon’s 51:49 JV with CIMAB SA, to manufacture monoclonal antibodies and other Recombinant Therapeutics. BBPL commenced operations during the current year and has primarily been engaged in the manufacture of BIOMAb-EGFR™ for the treatment of Head and Neck cancer.

 

As at March 31, 2008, BBPL had accumulated losses of Rs.325,611. Biocon’s share in the accumulated losses of BBPL aggregates Rs.166.062. Approval of BIOMAb-EGFR™ for new indications and commencement of sales to global markets is expected to help improve profitability in fiscal 2010.

 

 

MANAGEMENT'S DISCUSSION AND ANALYSIS 

  
Industry Structure and Development:

 

The global pharmaceutical sales grew 6 percent at constant exchange rates in 2007, to reach a record USD 712 billion. North America, Europe and Japan continued to account for about 80 percent of the total global pharmaceutical market, with North America experiencing slower growth at 4 percent. Emerging markets in Asia and Latin America continued to outpace global performance with double-digit growth. In terms of regional performance, North America, which accounts for 43 percent of global pharmaceutical sales, grew 4 percent, to USD 305 billion, while Europe buoyed by the appreciating Euro experienced higher growth of 7 percent, to USD 206 billion. Sales in Latin America grew 12 percent to USD 32 billion, while Asia Pacific (outside of Japan) and Africa grew 13 percent to USD 62 billion with China, Korea and India growing by 26 percent, 11 percent, and 13 percent respectively. Sales in Japan reversed the decline experienced in the previous year on account of the biennial price cuts which occurred April, 2006 and grew 4 percent to USD 59 billion.

 

Oncologics grew 16 percent to USD 41 billion and displaced Lipid Regulators as the top selling therapy class for 2007. Patent expiry of Zocor® and declining sales of Lipitor® partially contributed to Lipid Regulators sales declining by 7percent to USD 34 billion. Respiratory Agents with sales of USD 29 billion grew 12 percent and retained its position as the third largest class of therapeutic drugs. Antidiabetics at the 5th position also experienced double digit growth with sales of USD 24 billion.

 

The biopharmaceutical market represented 10 percent of the global pharmaceutical market, having grown 17 percent in 2007 and the double-digit growth of the market is expected to continue to the end of the decade.

 

Generic Pharmaceutical Industry:

 

The generic drugs market refers to regulated markets for drugs whose patents have expired or been invalidated. The expiration or invalidation of product patents typically leads to the entry of generic, or non-branded, formulations in the regulated markets, resulting in increased competition and leading to a decline in price and margin of drugs.

 

Drugs with approximately $20 billion in annual sales will face patent expiry in 2008, similar to levels seen over the past two years. This is expected to drive growth of generics by 14-15 percent next year, to more than $70 billion. In 2008, more than two-thirds of all prescriptions written in the U.S. are expected to be for generics. New government contracting initiatives in Germany, and educational programs in Japan, Spain and Italy, will drive greater generics use in those markets. Also, generics competition within the biotech sector will rise as the biosimilarepoeitinalfa is marketed across Europe. This trend reflects a changing balance between new and old products and a growing ‘genericization’ of many primary care categories. Low cost producers such as India and China are expected to play a key role in the development of the generics industry.


Outlook: 

 

The global pharmaceutical market is expected to grow at a 5-6 percent in 2008, compared with 6 percent in 2007. In the U.S. and the five largest European markets, sales growth in 2008 is expected to range from 4-5 percent and 1-2 percent in Japan. Key factors limiting growth in these markets include: a leveling off of growth from the introduction of the Medicare Part D prescription drug benefit in the U.S.; patent expiration of branded product, and an associated increase in the use of lower-cost generics; increased pressure from payers to control costs and limit access to certain treatments; and heightened safety scrutiny and healthcare legislation that is slowing, and in some cases halting, the introduction of new medicines. The seven “pharmerging” markets of China, Brazil, Mexico, South Korea, India, Turkey and Russia are expected to grow 12-13 percent next year, to $85-90 billion. In these markets, there is signifi cantly greater access both to generic and innovative new medicines as primary care improves and becomes more available in rural areas, and as private health insurance becomes more commonly held. Ongoing economic growth in the developing world will continue to shift the focus away from infectious diseases and toward cardiovascular, diabetes and other chronic illnesses.


Opportunities: 


The surge in generics together with the expected patent expiry of key immunosuppressant drugs provides Biocon with attractive opportunities in the near to medium term. In addition the opening up of bio-similar in US and Europe is seen as a large opportunity in the medium term. Success in Biocon’s Research and Development initiatives into new drug discovery could also yield significant benefits.

 

Bio-pharmaceuticals:

 

In pharma, they focus on the manufacture and marketing of APIs that require fermentation and synthetic chemistry skills. their biopharmaceuticals business contributes towards 94.5 percent & 88.5 percent of theirsales in 2007-08 and 2006-07 respectively.

 

Statins:

Statins are cholesterol-lowering agents used to treat and prevent coronary diseases and are amongst the largest selling drugs worldwide. The Company’s statins portfolio presently comprises lovastatin, simvastatin, pravastatin, atorvastatin besides other statins under development. Biocon is currently exporting simvastatin to the US, Europe, Japan and Canada, lovastatin to the US and pravastatin to the US and European markets. The Company has over the years been facing severe pricing pressure in this segment due to increased competition and changing industry price dynamics.

 

The US patent for Simvastatin and Pravastatin expired during fiscal 2007 and the Company has commenced exports to USA in the 2nd half of fiscal 2007. The Company has also during the year received US FDA qualifi cation for its new facilities at Biocon Park thereby substantially increasing the production capacity to address the Statin global demand.

 

Immunosuppressants:

Immunosuppressants prevent organ and tissue rejection in transplants and require high technology based manufacturing capabilities. Currently Biocon produces mycophenolate mofetil (MMF), sirolimus and tacrolimus. MMF and tacrolimus are sold largely in the domestic market and certain export markets. Biocon will actively promote it’s product in the US, Japanese and European markets. Biocon has filed a DMF for MMF, tacrolimus and sirolimus to address the US markets following patent expiry.

 

Other biopharmaceutical products:

Subject also supplies a range of other Biopharmaceutical products. Biocon markets recombinant human insulin in India under its own brand name INSUGEN and has also registered the Insulin in several export markets. In addition Company has supply arrangements with Pharma Majors and device companies to supply recombinant human insulin for use in their novel insulin formulations. Some of these delivery systems are undergoing clinical trials.

 

Sale of Formulations:

Company has a dedicated marketing team for finished formulations. This segment, though in the nascent stage, has been growing rapidly. With a focus on the anti-diabetic and cardio-vascular market, Biocon’s own insulin brand ‘Insugen’ is also marketed by the formulation team. The formulation segment currently has a team which comprises of field staff spread across the country, with sales registering impressive growth in FY 2008 as compared to FY 2007. During the fiscal year 2008, Subject launched its new Nephrology Division and a comprehensive portfolio of renal therapy products. Biocon’s Nephrology division is committed to finding solutions to kidney disorders using the highest standards of biotherapeutics and will simultaneously strive towards reducing the risks of the disease in the future, through progressive research and innovative therapies. Company also launched BIOMAb-EGFR™, a therapeutic monoclonal antibodybased drug for treating solid tumors of epithelial origin, such as head and neck cancers. BIOMAb-EGFR™ is produced at Biocon’s state-of-the-art manufacturing facility at Biocon Park.

 

Enzymes

Company develops and markets a mix of specialty and industrial enzymes for a broad range of industries including food, beverages, brewing and distilling, textiles and paper. The enzymes business has been sold to M/s. Novozymes South Asia Private Limited during the year. Hence, Enzymes sales are only recorded for the first 6 months during the fiscal 2008.

 

Technical Licensing Fees

These fees represent income received by Biocon towards transfer of proprietary technology in respect of certain bio-generics under long term contracts. They also include fees received by Biocon towards out-licensing it’s proprietary products. During the year, there has been an increase of Rs.176.061 Million in respect of such fees from Rs.272.352 Million in fiscal 2007 to Rs.448.413 Millions in fiscal 2008. Company is committed towards tapping more revenues from this source by scaling up a large number of bio-generics including Insulin, GCSF, ERYPRO, Streptokinase, Retiplase, etc. and advancing their discovery programs including oral insulin and Monoclonal Antibodies against CD6, EGFR, CD 20 & CD 10.

 

Other Income

The Other income has registered a increase of 331.7 percent compared to the previous year. Other income consists primarily of dividend income from investment amounting to Rs.138.746Million as compared to Rs2.922Million in the fiscal 2007. It also includes milestone receipts of Rs.174.997Million and charges billed to group companies for services rendered for support services which have increased from Rs.70.792Million in fiscal 2007 to Rs169.202Million in fiscal 2008.

 

Material costs

Material costs include Biocon’s consumption of raw materials and traded goods and increases or decreases in stock. Materials costs have decreased by 5.9 percent from Rs.4158.125Million to Rs.3914.284Million over the previous year. But as a percentage of sales, the material cost has decreased by 3.5 percent mainly on account of increased manufacturing activity and reduction in sourcing of advanced intermediates.

 

Employee costs

 

Staff cost comprises:

 

• Salaries, wages, allowances and bonuses;

• Contributions to provident fund;

• Contributions to superannuation, gratuity and leave encashment;

• Amortisation of Employees stock compensation expenses, and

• Welfare expenses (including employee insurance schemes and other miscellaneous employee benefits) Staff costs has increased from Rs.603.735Million for the fiscal year 2007 to Rs.696.263Million for the fiscal year 2008. The increase in employee costs is mainly due to increments during the year and addition to employees.

 

 

Operating and other expenses

Operating and other expenses comprises of rent; traveling and conveyance; communication; professional charges; power and fuel; patent fees; consumables; repairs and maintenance; general expenses; freight outwards; sales promotion; commissions; bad debts write off; provisions for bad and doubtful debts; printing and stationary; insurance; rates, taxes and fees; and losses on sales of assets. Operating and other expenses have increased by 26.3 percent from Rs1504.830Million for the year 2007 to Rs.1900.804Million for the year 2008 mainly on account of the following:

 

- 23 percent increase in power and fuel costs from Rs.620.715 Million in fiscal 2007 to Rs.761.171 Million in fiscal 2008 and 26 percent increase in repairs and maintenance costs from Rs.166.500 Million in the previous year to Rs209.925 Million in fiscal 2008 on account of increase in production activity at Biocon Park.

 

- 20 percent increase in research and development expenses from Rs.159.738 Million to 191.169 Million on account of increase in their ongoing research initiatives including the oral insulin project.

 

- 38.8 percent increase in selling expenses from Rs.226.415 Million in FY 2007 to Rs.314.246 Million in FY 2008 due to increased sales of Healthcare products and launch of oncology and nephrology marketing division.

 

 

PERFORMANCE OF SUBSIDIARIES

 

Syngene International Limited

 

Syngene is a 99.99 percent owned subsidiary of Biocon Limited. Syngene was incorporated on November 18, 1993 with an authorized share capital of Rs.5.000 Millions. Syngene works in two main research areas: Synthetic chemistry and molecular biology. Syngene is also involved in custom chemical synthesis.

 

Syngene’s total income primarily consists of net sales from contract research services and sales of compounds. Substantially all Syngene’s contracts are based on time and material management. Revenue from these contracts are recognised as and when services are rendered, in accordance with the terms of the contract. Syngene’s total revenue has increased Rs.1316.928 Millions to Rs1604.283 Millions representing a growth of 22 percent. This growth in revenue is on account of increase in the number of clients. In addition, Syngene’s income from investment of its surplus funds in mutual fund units has decreased from Rs.34.150 Millions in the fiscal 2007 to Rs 23.419 Millions in the fiscal 2008.

 

Syngene’s expenses mainly comprises of raw-material costs and staff costs. Raw material cost consists of lab consumables used for research. The increase in revenue was mainly offset by increase in material cost by 39 percent from Rs.349.060 Millions in fiscal 2007 to Rs.483.715 Millions in fiscal 2008 and staff cost by 40 percent from Rs.261.855 Millions to Rs.366.835 Millions as compared to the previous year. Increase in material cost and staff cost are due to increased business and increase in head count. Other costs increased by 95 percent from Rs.121.387 Millions to Rs.236.438 Millions in fiscal 2008.

 

Clinigene International Limited

 

Clinigene is a 100 percent owned subsidiary of Company. Clinigene was incorporated on August 4, 2000 with an authorised share capital of Rs5.000 Millions. Clinigene was established to undertake clinical and other trials and validation for drugs and pharmaceuticals and to conduct research in the area of medical sciences for development of new and improved drugs.

 

Clinigene’s total income principally consists of income from clinical research fees and also Bio-analytical and Bio-equivalence studies. Clinigene enters either into time and material contracts and/or fixed price arrangements. Revenue from time and material contracts are recognised on a monthly basis as services are rendered in accordance with the terms of the applicable contracts. Revenue from fixed price contracts is recognised based on the percentage completion method. Total revenue of Clinigene increased from Rs115.502 Millions in fiscal 2007 to Rs227.163 Millions in fiscal 2008, primarily on account of increase in clinical research fees.

 

Clinigene’s expenses comprise of research material costs, consultancy fees, staff cost, and other operating expense, interest cost, depreciation and provisions for fringe benefi t tax. Consultancy fees has increased by 20 percent from Rs9.230 Millions to Rs11.075 Millions as compared to 2007, Clinigene’s staff cost has increased by 46.2 percent from Rs32.252 Millions to Rs47.147 Millions as compared to previous year. This is because Clinigene is in the process of developing its clinical research capabilities and is hiring employees. As Clinigene require additional funds to develop its capabilities and become profitable, Company is supporting it in its funding. The interest expenses have increased from Rs9.010 Millions to Rs9.807 Millions on account of borrowings for setting up of its new clinical research facility at Semicon Park. As at March 31, 2008, it had accumulated losses of Rs31.207 Millions. Profit for the year ended March 31, 2008 of Rs23.739 Millions as against Rs7.812 Millions in the previous year, has been consolidated with the profits of the group in the consolidated financial statements.

 

Biocon Biopharamaceuticals Private Limited

 

BBPL is a joint venture company and currently 51 percent of its shares are held by Biocon and the balance 49 percent by CIMAB, Cuba. BBPL was incorporated on June 17, 2002 with an authorised share capital of Rs.500.000 Millions and in the year 2004 increased to Rs.10.000 Millions. In 2007 the authorized share capital was increased from Rs132.000 Millions to Rs.440.000 Millions. BBPL has been established to produce and sell certain biological. BBPL has commenced commercial operations during fiscal 2008. Company holds 8,976,000 equity shares and CIMAB holds 8,624,000 equity shares of Rs.10 each respectively.

 

As at March 31, 2008, BBPL has accumulated losses of Rs325.611 Millions. Biocon’s share in the accumulated losses of BBPL aggregates Rs166.062 Millions.

 

 

Contingent liabilities

Rs in millions

31.03.2008

(a) Taxation matters under appeal

44.336

(b) Corporate guarantees

 

(i) Corporate guarantee given in favour of the CED in respect of certain performance obligations of Syngene. The Company has informed that necessary terms and conditions have been complied with and no liabilities have arisen

217.500

(ii) Corporate guarantee given by Syngene in favour of the CED in respect of certain performance obligations of Biocon.

465.000

(c) Corporate guarantees given in favour of the CED in respect of certain performance obligations of BBPL. The Company has informed that the necessary terms and conditions have been complied with and no liabilities have arisen

131.352

(d) Corporate guarantees given in favour of the CED in respect of certain performance obligations of Clinigene. The Company has informed that the necessary terms and conditions have been complied with and no liabilities have arisen

27.205

e) Corporate guarantees given in favour of State Bank of India (SBI), towards Term loan granted  to BBPL. The Company has informed that the necessary terms and conditions have been complied with and no liabilities have arisen

650.000

(f) Claims against the Company not acknowledged as debts

-

 

Fixed Assets

 

 

 

Milestone

 

Year

Key Events, Milestones and Achievements

 

 

November 1978

Biocon commenced operations as a joint venture between the promoter Ms. Kiran Mazumdar-Shaw and Biocon Biochemical’s Limited, an Ireland based multinational. The company began the manufacture and export of Papain, a plant enzyme, and Isinglass, a marine hydrocolloid, which are key products for the brewing industry

July 1982

BCZ was incorporated to focus on research and development in relation to enzymes.

1984

Biocon began focussing on research and development, to develop novel enzymes for the Biocon group worldwide through solid-state fermentation process technology referred to as "koji technology".

April 1989

HLX was incorporated as a pharmaceutical biotechnology company, which later diversified into pharmaceutical bulk activities.

July 1989

Biocon along with Unit Trust of India/Technology Development and Investment Corporation of India (UTI/TDICI), Biocon Biochemical’s Limited, Ireland and others invested in BCZ.

November 1992

UTI/TDICI transferred their entire shareholding in BCZ to Biocon Limited, Ireland. BCZ commenced operations

January 1993

Bicon received ISO 9001 accreditation from RWTUV, Germany

November 1993

Syngene was incorporated as a CRO to conduct research for third party clients in the area of drug discovery and development. Syngene's skill set in the areas of molecular biology and synthetic chemistry are complementary to their expertise in the areas of fermentation and microbial genetics.

February 1995

Unilever acquired 50% of the shares in BCZ by acquiring the entire shareholding of Biocon Biochemicals Limited, Ireland and Biocon Limited, Ireland.

Unilever also acquired shares in Biocon from Biocon Biochemicals Limited, Ireland and Biocon Limited, Ireland and others

December 1995

BQIL was established with their Company and Unilever acquiring around 50% stake each. BQIL commenced manufacturing operations from August 1996

February 1998

HLX commenced manufacturing operations

June 1999

Glentec International acquired the entire shareholding of Unilever in BCZ, BQIL and the company.

March 2000

The company acquired the entire shareholding of BCZ, BQIL & HLX from Glentec International, Ms. Kiran Mazumdar-Shaw and others in exchange for issue of shares by the  Company.

 

Glentec International acquired a majority stake (approx 64%) in Syngene as part of a fresh issue of shares.

March 2000

ICICI Ventures and its affiliate funds were inducted as shareholders of the company by way of subscription to 15.35% of the share capital of the company.

May 2000

ICICI Ventures, and its affiliate funds also acquired 10% in Syngene from Glentec International.

May 2000

The company’s proprietary bioreactor christened PlafractorTM based on solid matrix fermentation received a U.S. patent

December 2000

Clinigene was incorporated to conduct longitudinal clinical studies in select disease segments as a wholly owned subsidiary of the company.

January 2001

As part of a court based restructuring, BCZ, BQIL and HLX were amalgamated into the company, with effect from April 1, 1999.

The company Lovastatin facility was approved by the US FDA

March 2002

The company acquired 99.99% of Syngene from its other shareholders, including ICICI Venture and its affiliate funds, which divested their entire stake in Syngene in exchange for issue of shares by the company. Syngene was made a 99.99% subsidiary of Biocon Limited.

March 2003

BBPL was incorporated to manufacture and market a select range of biotechnology based life saving drugs as a 51:49 joint venture with CIMAB and the company

May-September 2003

ICICI Ventures along with its affiliate funds divested its shareholder interests in the company in favour of other private equity funds, being AIG AOF, a wholly owned subsidiary of AIG Asian Opportunity Fund L.P. and IVF and also to the Welfare Trust.

March 11, 2004

Biocon goes for an IPO to raise Rs 3000.000 millions to fund its huge capital expansion plans.

March 18, 2004

Biocon's IPO gets oversubscribed 32 times

 

 

Board of Directors

 

Dr. Neville Bain Chairman, Institute of Directors, UK Board Member, Scottish & Newcastle Plc., Provexis Limited Former Group CEO, Coats Viyella Plc. Former Deputy Group Chief Executive and

Finance Director, Cadbury Schweppes Plc. Author of several management books on corporate governance, strategy and people management

 

Prof. Charles L. Cooney Professor, Chemical & Biochemical Engineering, MIT, USA Director, Genzyme Inc. and Bio-Processors Inc. Recipient of prestigious awards, including Gold Medal of the

Institute of Biotechnology Studies and Distinguished Service Award from the American Chemical Society

 

Dr. Bala S. Manian Chairman and Co-founder, Reametrix Inc. Co-founder, Quantum Dot Corporation and Surromed Corporation, USA Expert in the design of electro-optical systems Authored several peer-reviewed scientifi c publications and holder of many patents Recognised through several awards for contributions as educator, inventor and entrepreneur, including Technical Academy Award in Digital Cinematography by Academy of Motion Pictures, Arts and Sciences

 

Prof. Ravi Mazumdar University Research Chair Professor, Department of Electrical and Computer Engineering, University of Waterloo, Canada Fellow of the Institute of Electrical and Electronics Engineers (IEEE) and Fellow of the Royal Statistical Society

 

Dr. Kiran Mazumdar-Shaw Chairman & Managing Director, Biocon First generation entrepreneur with more than 28 years experience in biotechnology and industrial enzymes Master Brewer, Ballarat University, Australia Awarded the Padmabhushan, one of India’s highest civilian awards, for her pioneering efforts in Biotechnology, 2005

 

Prof. Catherine Rosenberg University Research Chair Professor and Chairman, Department of Electrical and Computer Engineering, University of Waterloo, Canada

 

Mr. John Shaw Vice Chaiman, Biocon Served in senior positions in various locations around the world Chairman, Madura Coats Limited between 1991-1998

 

Mr. Suresh Talwar Partner, Crawford Bayley & Company., an Indian law firm of repute. Director, Cadbury India Limited, Birla Sun Life Insurance Company Limited, L&T Limited Area of professional specialisation includes

corporate law and related fields Legal counsel to numerous Indian companies, multinational corporations and Indian/foreign banks

 

Established in 1994 as a subsidiary of Biocon, Syngene is a chemical synthesis-driven Custom Research Company (CRC). They are the first Indian biotechnology CRC to receive special export status by the Government of India.

Lead by their synthetic chemistry division, Syngene specialises in developing high value organic molecules through multi-step synthesis involving diverse and complex chemistries. Extending their expertise to molecular biology, they have also developed an impressive capability to produce biopharmaceuticals through rDNA technology using microbial, yeast and mammalian host systems.

Collaborative work underlines Syngene's work ethos. Their team of highly skilled scientists closely interacts with their global clients to offer them quality services with particular attention to confidentiality, time-lines and cost-effectiveness.

Syngene

 

Syngene is an internationally reputed Custom Research Company (CRC) with multi-disciplinary skills in synthetic chemistry and molecular biology. Leveraging the convergence of information technology and biotechnology, they conduct high value R&D in early stage drug discovery and development for a diverse global clientele.

 

A subsidiary of Biocon, Syngene provides customised R&D services to the pharmaceutical and biotechnology sectors, on a strong platform of confidentiality and intellectual property protection. With state-of-the-art facilities, dedicated connectivity and highly qualified researchers, they offer their customers a powerful value advantage in the field of outsourced research and development

 

 

Press release

 

Biocon launches nano drug...

 

July 19, 2008

Publication: Business Line

 

Expects to clock Rs.100.000 Millions in the first year


Biocon Ltd says it expects its just-launched breast cancer drug Abraxane to become an Rs.1000.000 Millions product over three years.


The nano particle-based drug, unveiled here on Friday, is developed by Abraxis Bioscience Inc and marketed by Biocon within the country and some more regions.


The paclitaxel protein and albumin bound medicine is available as a single-use 100 mg vial for intravenous administration. The drugs controller General of India approved it in October 2007.


Addressing a news conference, Biocons chairwoman and Managing Director, Ms Kiran Mazumdar-Shaw, called it a breakthrough therapy recommended as a safe, `gold standard second line defence for patients for whom combination therapy has failed or the tumour recurs after six months of chemotherapy. One breast cancer cases are detected a year in India and 45,000 women die of it, she said, adding that the medicine would be affordable, easily available and have fewer side effects over certain alternatives.


Mr. Rakesh Bamzai, President Marketing, Biocon said the Rs.1000.000 Millions domestic markets for taxanes was alarmingly heading towards double the size in the next three years. Biocon expected to earn Rs.100.000 Millions in the first year.


We want to build it into a Rs.1000.000 Millions product in the next 3-4 years. We have also made sure it would be affordable. We will look at the other taxanes and price it accordingly. A vial costs $400 (around Rs.17, 200) compared with $1000 in the US (around Rs.43, 000).


Under an August 2007 marketing tie-up, Biocon is licensed to market, Abraxane in India, Pakistan, Bangladesh, Sri Lanka, the UAE, Saudi Arabia, Kuwait and a few more South Asian and Persian Gulf countries.

 

 

 

Biocon and Abraxis BioScience Launch ABRAXANE in India for Treatment of Breast Cancer

 

BANGALORE, India, & LOS ANGELES, Jul 18, 2008 (BUSINESS WIRE) -- Biocon Limited, India's pioneering biotechnology company, and Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated biotechnology company, today announced the launch of ABRAXANE(R) (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in India for the treatment of breast cancer after failure of combination therapy for metastatic disease or relapse within six months of adjuvant chemotherapy. ABRAXANE is now available in India as a single-use 100 mg vial (as a lyophilized powder, to be reconstituted for intravenous administration).

 

In October 2007, ABRAXANE was approved by the Drug Controller General of India. The approval was based on the clinical trial data that was the basis of approval in the United States. The Phase III clinical trial in the U.S. demonstrated that ABRAXANE nearly doubled the response rate, significantly prolonged time to progression, and significantly improved overall survival in the second-line setting versus solvent-based Taxol(R) in the approved indication.

 

In the U.S. pivotal head-to-head trial, the overall response rate of ABRAXANE was 33% vs. 19% compared to Taxol (P = .001), and ABRAXANE achieved a 25% percent improvement in time to tumor progression (23.0 weeks vs. 16.9 weeks; hazard ratio = 0.75; P = .006) when compared to Taxol. Furthermore, patients receiving ABRAXANE in the second-line setting had a significantly prolonged survival by an additional 27% compared to solvent-based Taxol (56.4 weeks vs. 46.7 weeks; P = 0.24). The tolerability with ABRAXANE and Taxol was comparable, despite the 50% greater dose of paclitaxel administered as ABRAXANE.

 

"The launch of ABRAXANE in India represents a major strategic step in our plan to provide safer and more effective cancer treatments on a global scale," said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of Abraxis BioScience. "In addition to India, our marketing agreement with Biocon covers more than ten countries, and we are working closely with national authorities throughout the region to receive regulatory approvals and commence marketing activities as soon as practicable."

 

"This launch provides breakthrough therapeutics to cancer patients in India," said Kiran Mazumdar-Shaw, Chairman & Managing Director of Biocon. "ABRAXANE is a significant advance in taxane therapy for the treatment of breast cancer. This unique product eliminates the need for chemical solvents and allows for higher doses of paclitaxel without compromising safety and tolerability. The launch of ABRAXANE reiterates our belief in strategic licensing partnerships to advance therapeutics in India, and we take great pride in providing oncologists in India with the latest treatment in breast cancer."

 

Ms. Mazumdar-Shaw noted that ABRAXANE is an important addition to Biocon's Oncotherapeutics portfolio, which has already seen the successful launch of its proprietary antibody, BIOMAb EGFR(TM) for the treatment of head and neck cancers.

 

Neil Desai, Ph.D., Vice President of Research and Development at Abraxis BioScience, said, "ABRAXANE is the first nanotechnology based anti-cancer drug that is administered as albumin-bound particles of approximately 130 nanometers and takes advantage of albumin, a natural protein that acts as the body's key transporter of nutrients and other water-insoluble molecules and accumulates in tumor tissues. The drug has demonstrated superiority in progression free survival over both Taxol(R) Injection and Taxotere (R) Injection in recent randomized clinical trials. The initial clinical trials for ABRAXANE were conducted in India and we are very satisfied to be able to bring this drug to the Indian patients through our partner Biocon."

 

Rakesh Bamzai, President - Marketing, Biocon, said, "Presently, more than 100,000 new cases of breast cancer occur in Indian women every year. Breast cancer is the second largest cause of death among women diagnosed with cancer in India. With the launch of ABRAXANE through Biocon's innovation led Oncotherapeutics division and the growing need for this drug in the country, we look forward to attaining market leadership in this segment."

Cancer rates in India are lower than those seen in Western countries, but are rising with increasing migration of rural population to the cities, increasing life expectancy and changing lifestyles. The breast is the second most common site of cancer in women after the cervix uteri. In the metropolitan cities of New Delhi and Mumbai, it is the most common kind of cancer in women. The annual age-adjusted rate (AAR) varies between the urban and rural areas. In the urban areas, the AAR is 21.9 to 28.3 per 100,000, whereas in rural areas, it is 8.6 per 100,000.

In August 2007, Abraxis established a licensing agreement with Biocon for the commercialization of ABRAXANE in India. Under the terms of the agreement, Biocon has the right to market ABRAXANE in India, Pakistan, Bangladesh, Sri Lanka, the United Arab Emirates, Saudi Arabia, Kuwait and certain other South Asian and Persian Gulf countries. Subsequently, Abraxis received approval in October 2007 from India's Drug Control General to market ABRAXANE in India.

 

ABRAXANE is approved for marketing in 35 countries. Abraxis has several pending patent applications in India relating to ABRAXANE.

 

In the Asia-Pacific region, ABRAXANE is approved for marketing in China and Korea in addition to India. ABRAXANE is under regulatory review for the treatment of breast cancer by the Therapeutic Goods Administration (TGA) in Australia, the Federal Authority for Healthcare and Social Development Regulation in Russia, and the Ministry of Health, Labour and Welfare in Japan.

 

About ABRAXANE(R)

 

ABRAXANE(R) is a solvent-free chemotherapy treatment option for metastatic breast cancer. Developed using Abraxis BioScience's proprietary nab(TM) technology platform, ABRAXANE is a protein-bound chemotherapy agent, which combines paclitaxel with albumin, a naturally-occurring human protein, to deliver the drug and eliminate the need for solvents in the administration process. Because solvents are eliminated, ABRAXANE allows for the delivery of a 49% higher dose compared to solvent-based paclitaxel (Taxol(R)) without compromising safety and tolerability. ABRAXANE is administered in 30 minutes (as compared to three hours for solvent-based paclitaxel).

 

ABRAXANE is currently in various stages of investigation for the treatment of the following cancers: first-line metastatic breast, non-small cell lung, malignant melanoma, pancreatic, and gastric. The most serious adverse events associated with ABRAXANE in the randomized metastatic breast cancer study for which FDA approval was based included neutropenia, anemia, infections, sensory neuropathy, nausea, vomiting and myalgia/arthralgia. Other common adverse reactions included anemia, asthenia, diarrhea, ocular/visual disturbances, fluid retention, alopecia, hepatic dysfunction, mucositis and renal dysfunction. For the full prescribing information for ABRAXANE, including Boxed Warning, please visit www.abraxane.com.

ABRAXANE was developed by Abraxis BioScience and is marketed in the United States under a co-promotion agreement between Abraxis and AstraZeneca.

 

About Biocon Limited

 

Biocon Limited is India's pioneer biotechnology enterprise established in 1978. Biocon and its two subsidiaries, Syngene and Clinigene form a fully integrated biotechnology enterprise, with specialized focus on biopharmaceuticals, contract research and clinical research. Strategic international acquisitions, such as acquiring a majority in the German pharmaceutical company, AxiCorp, have given Biocon wider global access and greater market penetration. Many of our products have USFDA and EMEA acceptance.

 

Biocon's proprietary technologies have been used effectively in diabetology, oncology, cardiology, nephrology and other therapeutic treatments. The company's robust drug discovery pipeline offers novel therapies on a platform of affordable innovation. Biocon launched the world's first recombinant human insulin, INSUGEN(R) in November 2004 using Pichia expression and India's first indigenously produced monoclonal antibody BIOMAb-EGFR(TM) in September 2006. Visit the company at www.biocon.com

 

About Abraxis BioScience

 

Abraxis BioScience is a fully integrated global biotechnology company dedicated to the discovery, development and delivery of next-generation therapeutics and core technologies that offer patients safer and more effective treatments for cancer and other critical illnesses. The company's portfolio includes the world's first and only protein-bound chemotherapeutic compound (ABRAXANE), which is based on the company's proprietary tumor targeting technology known as the nab(TM) platform. The first FDA approved product to use this nab(TM) platform, ABRAXANE, was launched in 2005 for the treatment of metastatic breast cancer. Abraxis trades on the NASDAQ Global Market under the symbol ABII. For more information about the company and its products, please visit www.abraxisbio.com.

 

FORWARD-LOOKING STATEMENTS

 

The statements contained in this press release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include statements regarding our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding the launch of ABRAXANE in India. Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, without limitation, unexpected safety, efficacy or manufacturing issues with respect to ABRAXANE; the need for additional data or clinical studies for ABRAXANE; regulatory developments (domestic or foreign) involving the company's manufacturing facilities; the market adoption and demand of ABRAXANE, the costs associated with the ongoing launch of ABRAXANE; the impact of pharmaceutical industry regulation; the impact of competitive products and pricing; the availability and pricing of ingredients used in the manufacture of pharmaceutical products; the ability to successfully manufacture products in a time-sensitive and cost effective manner; the acceptance and demand of new pharmaceutical products; and the impact of patents and other proprietary rights held by competitors and other third parties. Additional relevant information concerning risks can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2007 and in other documents it has filed with the Securities and Exchange Commission.

 

The information contained in this press release is as of the date of this release. Abraxis assumes no obligations to update any forward-looking statements contained in this press release as the result of new information or future events or developments.

 

 

Representative Offices:

 

Human Resources

Phone: 91-80-28082808

Email: human.resources@biocon.com

 

Licensing/ Collaboration Opportunities

 

To submit licensing/collaboration opportunities enquiries:

Mr. Sandeep Rao

General Manager – Business Development

Phone: 91-80-28082070

Email: sandeep.rao@biocon.com

 

Healthcare

For business related and medical professional enquiries regarding our cardiology and diabetology products:

Mr. KRL Rao

General Manager – Healthcare

Phone: 91-80-28082061

Email: krl.rao@biocon.com

 

Oncology

For business related and medical professional enquiries regarding our oncology products:

Mr. Shukrit Chimote

General Manager – Oncotherapeutics

Phone: 91-80-28082161

Email: shukrit.chimote@biocon.com

 

Nephrology

For business related and medical professional enquiries regarding their nephrology products:

Mr. Raghava Vempati

Head – Nephrology

Phone: 91-80-28082152

Email: raghava.vempati@biocon.com

 

Pharmaceuticals

For Domestic and Export enquiries on our Active Pharmaceutical Ingredients (Bulk Drugs):

Ms. Preeti Dharmagoudar

Sr. Manager – Marketing

Phone: 91-80-28082808

Email: preeti.goudar@biocon.com

 

Contract Research

For business related enquiries regarding our contract research services:

Mr. Narendra Kumar R

General Manager – Business Development

Phone: 91-80-28083181

Email: narendra.kumar@syngeneintl.com

 

Clinical Research

For business related enquiries regarding our clinical research services:

Dr. Gaurav Mathur

Manager - Business Strategy & Regulatory Affairs

Phone: 91-80-28082732

Email: gaurav.mathur@clinigeneintl.com

 

Investor Relations

For investor related queries :

Mr. Kiran Kumar

Company Secretary

Phone: 91-80-28082037

Email:investor.relations@biocon.com

 

Corporate Communications

For media related queries:

Ms. Paula Sengupta

Head - Corporate Communications

Phone: 91-80-28082225

Email: corporate.communications@biocon.com


Ms. Sonia Sharma

Branch Head – Brodeur India

Phone: 91-80-40429047

Email: ssharma2@brodeurindia.com

 

 

 

 


 

CMT REPORT (Corruption, Money Laundering & Terrorism]

 

The Public Notice information has been collected from various sources including but not limited to: The Courts, India Prisons Service, Interpol, etc.

 

1]         INFORMATION ON DESIGNATED PARTY

No exist designating subject or any of its beneficial owners, controlling shareholders or senior officers as terrorist or terrorist organization or whom notice had been received that all financial transactions involving their assets have been blocked or convicted, found guilty or against whom a judgement or order had been entered in a proceedings for violating money-laundering, anti-corruption or bribery or international economic or anti-terrorism sanction laws or whose assets were seized, blocked, frozen or ordered forfeited for violation of money laundering or international anti-terrorism laws.

 

2]         Court Declaration :

No records exist to suggest that subject is or was the subject of any formal or informal allegations, prosecutions or other official proceeding for making any prohibited payments or other improper payments to government officials for engaging in prohibited transactions or with designated parties.

 

3]         Asset Declaration :

No records exist to suggest that the property or assets of the subject are derived from criminal conduct or a prohibited transaction.

 

4]         Record on Financial Crime :

            Charges or conviction registered against subject:                                                  None

 

5]         Records on Violation of Anti-Corruption Laws :

            Charges or investigation registered against subject:                                                          None

 

6]         Records on Int’l Anti-Money Laundering Laws/Standards :

            Charges or investigation registered against subject:                                                          None

 

7]         Criminal Records

No available information exist that suggest that subject or any of its principals have been formally charged or convicted by a competent governmental authority for any financial crime or under any formal investigation by a competent government authority for any violation of anti-corruption laws or international anti-money laundering laws or standard.

 

8]         Affiliation with Government :

No record exists to suggest that any director or indirect owners, controlling shareholders, director, officer or employee of the company is a government official or a family member or close business associate of a Government official.

 

9]         Compensation Package :

Our market survey revealed that the amount of compensation sought by the subject is fair and reasonable and comparable to compensation paid to others for similar services.

 

10]        Press Report :

            No press reports / filings exists on the subject.

 

 

CORPORATE GOVERNANCE

 

MIRA INFORM as part of its Due Diligence do provide comments on Corporate Governance to identify management and governance. These factors often have been predictive and in some cases have created vulnerabilities to credit deterioration.

 

Our Governance Assessment focuses principally on the interactions between a company’s management, its Board of Directors, Shareholders and other financial stakeholders.

 

 

CONTRAVENTION

 

Subject is not known to have contravened any existing local laws, regulations or policies that prohibit, restrict or otherwise affect the terms and conditions that could be included in the agreement with the subject.

 

 

FOREIGN EXCHANGE RATES

 

Currency

Unit

Indian Rupees

US Dollar

1

Rs.42.40

UK Pound

1

Rs.83.57

Euro

1

Rs.66.02

 

 

SCORE & RATING EXPLANATIONS

 

SCORE FACTORS

 

RANGE

POINTS

HISTORY

1~10

8

PAID-UP CAPITAL

1~10

8

OPERATING SCALE

1~10

8

FINANCIAL CONDITION

 

 

--BUSINESS SCALE

1~10

9

--PROFITABILIRY

1~10

7

--LIQUIDITY

1~10

8

--LEVERAGE

1~10

8

--RESERVES

1~10

8

--CREDIT LINES

1~10

8

--MARGINS

-5~5

-

DEMERIT POINTS

 

 

--BANK CHARGES

YES/NO

NO

--LITIGATION

YES/NO

NO

--OTHER ADVERSE INFORMATION

YES/NO

NO

MERIT POINTS

 

 

--SOLE DISTRIBUTORSHIP

YES/NO

YES

--EXPORT ACTIVITIES

YES/NO

YES

--AFFILIATION

YES/NO

YES

--LISTED

YES/NO

YES

--OTHER MERIT FACTORS

YES/NO

YES

TOTAL

 

72

 

This score serves as a reference to assess SC’s credit risk and to set the amount of credit to be extended. It is calculated from a composite of weighted scores obtained from each of the major sections of this report. The assessed factors and their relative weights (as indicated through %) are as follows:

 

Financial condition (40%)            Ownership background (20%)                 Payment record (10%)

Credit history (10%)                    Market trend (10%)                                Operational size (10%)

 


 

RATING EXPLANATIONS

 

RATING

STATUS

 

 

PROPOSED CREDIT LINE

>86

Aaa

Possesses an extremely sound financial base with the strongest capability for timely payment of interest and principal sums

 

Unlimited

71-85

Aa

Possesses adequate working capital. No caution needed for credit transaction. It has above average (strong) capability for payment of interest and principal sums

 

Large

56-70

A

Financial & operational base are regarded healthy. General unfavourable factors will not cause fatal effect. Satisfactory capability for payment of interest and principal sums

 

Fairly Large

41-55

Ba

Overall operation is considered normal. Capable to meet normal commitments.

 

Satisfactory

26-40

B

Unfavourable & favourable factors carry similar weight in credit consideration. Capability to overcome financial difficulties seems comparatively below average.

 

Small

11-25

Ca

Adverse factors are apparent. Repayment of interest and principal sums in default or expected to be in default upon maturity

 

Limited with full security

<10

C

Absolute credit risk exists. Caution needed to be exercised

 

 

Credit not recommended

NR

In view of the lack of information, we have no basis upon which to recommend credit dealings

No Rating

 

 

 

PRIVATE & CONFIDENTIAL : This information is provided to you at your request, you having employed MIPL for such purpose. You will use the information as aid only in determining the propriety of giving credit and generally as an aid to your business and for no other purpose. You will hold the information in strict confidence, and shall not reveal it or make it known to the subject persons, firms or corporations or to any other. MIPL does not warrant the correctness of the information as you hold it free of any liability whatsoever. You will be liable to and indemnify MIPL for any loss, damage or expense, occasioned by your breach or non observance of any one, or more of these conditions