HISTORY OF DEVELOPMENT CURRENT INDICATORS DEVELOPMENT PROSPECTS

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Brook Simon
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1 HISTORY OF DEVELOPMENT CURRENT INDICATORS DEVELOPMENT PROSPECTS

2 1. COMPANY DESCRIPTION Biocad is a Russian full cycle biotechnological company. It deals with development, manufacture and promotion of original and biosimilars. The company has an in-house scientific unit the Engineering Immunology Center, founded on the basis of the scientific building of Engineering Immunology Institute, RAO Biopreperat. Pharmaceuticals are manufactured at the contemporary plant using high-performance equipment, in strict compliance with GMP standards. The Company manufactures all required drug substances in-house. The product promotion is achieved by a professional team of medical representatives and experts. The Company is engaged in large-scale clinical trials, proving the efficiency and safety of pharmaceuticals.

Pharmaceuticals are manufactured at the contemporary plant using high-performance equipment, in strict compliance with GMP standards.

3 2. STAGES OF DEVELOPMENT company foundation, commencement of the plant construction "from a scratch" - foundation of the Engineering Immunology Center - completion of the plant construction - the launch of Genferon, an original medication - development of the first in Russia G-CSF (Leucostim ) - the company occupies 5% of the immunobiology market in Russia - market launch of 2 new oncologic generics - registration of the first in Russia and one of the first in the world Interferon-beta-1b (Ronbetal ) in the original pharmaceutical form - implementation of Monoclonal antibodies project market launch of Genferon Light - a portfolio of oncologic generics has grown up to 7 preparations

immunobiology market in Russia - market launch of 2 new oncologic generics - registration of the first in Russia and one of the first in the world Interferon-beta-1b (Ronbetal ) in

4 3. BUSINESS MODEL Patients Doctors Opinion leaders Ministry of Health Биокад российская биотехнологическая компания полного цикла. MARKET Demand in new medications, Cost reduction for treatment Quality Price Clinical studies Exhibitions Publications Development from gene to finished pharmaceutical form New methods of gene engineering, laboratory equipment Manufacture of pharmaceuticals in compliance with GMP standards Modern equipment High-quality raw materials Promotion of pharmaceuticals BIOCAD INNOVATIONS

MARKET Demand in new medications, Cost reduction for treatment Quality Price Clinical studies Exhibitions Publications

5. SCIENTIFIC BASIS Center of Engineering Immunology: The Center was established as a result of reorientation of the scientists previously employed with Biopreparat, RAO, who were

The developments are based on a design approach (project management system). The Center is equipped for the pilot production.

5 5. SCIENTIFIC BASIS Center of Engineering Immunology: The Center was established as a result of reorientation of the scientists previously employed with Biopreparat, RAO, who were engaged in developments, ordered by the Ministry of Defense in the 80-90th. GLP quality assurance system (Good Laboratory Practice) has been implemented at the Center. The developments are based on a design approach (project management system). The Center is equipped for the pilot production. There is a vivarium and the laboratory analytical equipment for preclinical studies. Currently the Center employs over 50 scientists, including 14 Doctors of Science. The Center is headed by MD L.A. Denisov, the developer of the domestic interferon alfa.

6 6. RECOGNIZED LEADER IN BIOTECHNOLOGIES Interaction with Bio Industry Initiative (the program of the US State Department for conversion of the Russian biotechnologists who were previously employed with the Ministry of Defense of the Russian Federation): Project 2909 "Development of a production technology for trans-mucous and liquid injection pharmaceutical forms of IFN-b and their testing in medical practice Project period: The grants paid amounted to $1.8 mln. US dollars. The project has been successfully completed, the goals achieved. Project 2828 Development of a production technology for the substance, development of samples, pre-clinical trial, structural and functional studies and development of modified forms with enhanced pharmacologic properties of a recombinant L-asparaginase Erwinia carotovora. Project period: The grants paid amounted to $1.1 mln.us dollars. The project is under implementation. Project 901-L The launch of a production line for interferon-alfa2 substance and Genferon preparation. Project period: An interest-free loan for $0.8 mln. US dollars was received (repaid at the end of 2009) The project has been successfully completed, the goals achieved. Interaction with the Governmental authorities of the Russian Federation: In November 2009 owing to Genferon-light Biocad became one of the three suppliers of antiviral pharmaceuticals for the Federal Reserve. At the early 2010 the project of BIOCAD company for production of pharmaceuticals based on monoclonal antibodies was approved by the Committee for Modernization under the RF President. Implementation period:

medical practice Project period: 2004-2009. The grants paid amounted to $1.8 mln. US dollars. The project has been successfully completed, the goals achieved.

7 7. CURRENT PRODUCT PORTFOLIO Segment Product description, basic active substance Application Competitive products (manufacturers) Prices of competitors Gynecology Urology ARVI Genferon (suppositories) Interferon-alfa-2b Genferon light (suppositories) Interferon-alfa-2b Urogenital infections Viferon (Feron) 10-15% lower Urogenital infections, ARVI Viferon (Feron) 10-15% lower Leucostim (solution) Filgrastim Neutropenia after chemotherapy and transplantation Neupogen (Roche) Grasalva (Teva) Neupomax (Farmstandart) 50-60% higher 10-15% higher 5-10% lower Oncology Haematology Taksakad (solution) Paclitaxel Carboplatin (solution) Carboplatin non-small-cell lung cancer Lung cancer, ovarian cancer Abitaxel (Teva) Paclitaxel-ebewe (Ebewe) Paclitaxel-lance ( Lance-farm) Carboplatin-teva (Teva) Carboplatin- ebewe (Ebewe) Carboplatin -lance ( Lance-farm) 40-60% higher % higher 5-10% lower 15-30% higher 60-80% higher 20-30% higher Platicad (lyophilizate) Oxaliplatin Colorectal cancer Eloxatin (Aventis) Oxaliplatin- ebewe (Ebewe) 2.8 times higher 10-15% higher Gemcitare (lyophilizate) Gemcitabine Pancreatic/urinary bladder cancer Gemzare (Ely Lilly) Gemcitabine -pliva (Pliva-Lachema) 30-50% higher 10-15% higher Zolerix (solution) Zoledronic acid Tumor deposit in bones Aclasta/Zometa (Novartis) 2 times higher Neurology Ronbetal (solution) Interferon-beta-1b Multiple sclerosis Betaferon (Bayer Schering) Extavia (Novartis) 2 times higher 1.8 times higher

Leucostim (solution) Filgrastim Neutropenia after chemotherapy and transplantation Neupogen (Roche) Grasalva (Teva) Neupomax (Farmstandart) 50-60% higher 10-15% higher 5-10% lower Oncology

8 8. EFFICIENCY The practices of performance enhancement are widely used by the Company: TQM Minimum supply of raw materials Unification of production processes Control at all stages of production data accounting system 5S GMP+ISO Minimum areas, universal equipment Optimization and safety of work stations Contribution of all employees to the process optimization Continuous training and sharing knowledge Standardization of actions Well-defined functions and powers of all employees Prevention of errors Just in time Product manufacture strictly under the plan/ demand Instant awareness and modern communications Reduction in time loss to waiting

all employees to the process optimization Continuous training and sharing knowledge Standardization of actions Well-defined functions and powers of all employees

9 Indicators, $ 9. RESULTS Return on sales, % Financial indicators of BIOCAD, CJSC Proceeds from sales Net Profit Cost-efficiency % % % % % (forecast) 0% $ Income per 1 manufacturing worker (2009) $ Income per 1 sq.m. of production facilities (2009) $ $ $ $ 5.000$ 0$ Industry average BIOCAD 0$ Industry average BIOCAD

50.000.000 50% 40.000.000 40% 30.000.000 30% 20.000.000 20% 10.000.000 10% 0 2006 2007 2008 2009 2010 (forecast) 0% 400.

10 10. INDUSTRY OUTLOOK I. The Russian market is relatively small and has a significant growth potential Country Size of pharmaceutical market, $bn Pharmaceutical market share to GDP, % Pharmaceutical market per capita $/year USA % 704 Canada % 498 Japan % 622 Germany % 411 France % 459 Spain % 346 Italy % 277 Russia % 82 II. The share of domestic manufacturers is about 20%, and the government makes efforts to increase the share (import substitution) 100% 75% 50% 25% Goals of government-sponsored program «Pharma-2020» Manufacture in Russia Import of pharmaceuticals 0%

Pharmaceutical market per capita $/year USA 216.1 1.52% 704 Canada 16.3 1.24% 498 Japan 79.5 1.57% 622 Germany 34.5 1.07% 411 France 29.1 1.10% 459 Spain 14.9 1.

11 11. PRODUCTS CURRENTLY UNDER DEVELOPMENT Segment Description Application Market access date Net Sales in RF in 2009 Viral infections Peginterferon alfa Hepatitis 2012 $63 mln. Interferron-а2 nasal (Genferon-spray) ARVI 2011 $35 mln. Rituximab Non Hodgkin Lymphoms 2013 $111 mln. Trastuzumab Bevacizumab HER2/neu-positive breast cancer Metastatic colon, lung and breast cancer 2013 $35 mln $42 mln. Oncology Hematology Bortezomib Multiple myeloma 2012 $152 mln. Epoetin Anemia 2012 $120 mln. Docetaxel Breast cancer 2011 $26 mln. Irinotecan Colorectal cancer 2011 $14 mln. Fludarabine Non Hodgkin Lymphoms 2010 $7 mln. Vinorelbine Lung and breast cancer 2011 $10 mln. Granisetron antiemetic 2010 $7 mln.

Trastuzumab Bevacizumab HER2/neu-positive breast cancer Metastatic colon, lung and breast cancer 2013 $35 mln. 2014 $42 mln.

12 12. DEVELOPMENT $ Investments in development of product portfolio and production capacities Rearmament R&D $ $ $ $ New plant of biomedications $ Warehouse Laboratories $ Monoclonal anti-bodies Anti-cancer preparations $ Filgrastim (GKSF) Substance IFN-alfa Substance IFN-beta Pegylated forms 0$

000.000$ 5.000.000$ 4.000.000$ New plant of biomedications 3.000.000$ Warehouse Laboratories 2.000.000$ Monoclonal anti-bodies Anti-cancer preparations 1.

13 Indicators, $ Product quantity 13. FUTURE INCOME Forecast of financial indicators Sales, $ Net Profit, $ Product quantity

MOH Policy for dispensing NEOPLASTIC DISEASES DRUGS

MOH Policy for dispensing NEOPLASTIC DISEASES DRUGS All prescriptions for antineoplastic drugs must be accompanied by the MOH special form. All the attachments mentioned on this form shall be submitted