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OVERVIEW PRESENTATION

OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

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Page 1: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

OVERVIEW PRESENTATION

Page 2: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

Our mission

We help people live longer and healthier lives by delivering effective, safe and affordable comprehensive solutions in the life sciences

Our slogan

EXPANDING LIFE'S HORIZONS

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Page 3: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

BIOCAD is an international innovative biotech company specializingin world-class research, modern pharmaceutical production, pre-clinical and clinical studies.

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Page 4: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

> 45Registered products in portfolio

10Of them are biologics

>40Products at various stagesof registration

1500employees, including700 researchers

31laboratories

8international offices

4manufacturing sites

17 YEARSFounded in 2001. A leading Russia’s pharmaceutical company. Ranked First in Russian Rating of High Growth Technology Companies 2017.

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Page 5: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

AWARDS AND ACHIEVEMENTS• Russian Government Award 2016 for Excellence in Quality

of Production & Services and Implementing High-Performance Quality Management

• Winner of Development Award from Vnesheconombank(State Russian Bank of Development and Foreign Trade) as Best Project in Innovations and High Technologies

• Winner of Russian Rating of High Growth Technology Companies 2016

• Best Russia’s Employer 2016, Aon Best Employer

• Best Company in Made in Russia Award 2016 by SNOB Magazine

• Winner of TOP 50 Most Prominent People of Saint Petersburg 2016 (Dmitry Morozov)

• First place in Chemical Industry and ninth place in Russia: Labor Efficiency and Industry Leaders Award 2016

• Winner of Vector of Year (Platinum Ounce Award 2016)

• Winner of the first INDUSTRY Award for MABNEXT in 2014

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Page 6: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

BEGINNING

Before BIOCAD, I used to work in a bank for quite a lot of time, and one day I got bored. What does a banker actually create? Nothing.Money turns into money. And for me, money has never been the aim of work but just its result. In 2001, I set up the biotech company BIOCAD after buying the Immunology Engineering Center in Lyubuchany village. Researchers did not understand what I wanted—they considered business people to be threatsrather than partners. To assure them that I was really committed, I told them what was on my mind. I said,“You know, I have a dream. I want to create not just another company selling medicines. I want BIOCAD to become the best biotech company in Russia.”

Dmitry MorozovPresident of BIOCAD

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Page 7: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

HISTORY OF THE COMPANY

2001

Building a manufacturing site for drug products in Petrovo-Dalneye (Moscow)

2002

Creating an R&D center from the Engineering Immunology Institute in Lyubuchany (Moscow)

2005

Launching Genferon®, an original drug for the combination therapy of urogenital infections

2006

Launching Leucostim® (filgrastim), the first Russian granulocyte colony-stimulating factor

2011

Opening the second R&D center in Strelna (Saint Petersburg)

2012

Implementing the program “Pilot Manufacturing of Drug Substances and Products of Monoclonal Antibodies for Substituting High-Cost Imported Medications”

Page 8: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

HISTORY OF THE COMPANY

2013

Launching Algeron® (cepeginterferonalfa-2b), the first Russian original drug for the treatment of hepatitis C

2014

Launching Acellbia® (rituximab), the first Russian monoclonal antibody

2015

Registering Avegra® BIOCAD (Bevacizumab) and Herticad(trastuzumab), expanding R&D, launching ChemNext, a project to develop innovative chemical drugs

2016

Multiple-vector international expansion of products and technologies to South-East Asia, Middle East & North Africa, Latin America Creating a new R&D complex – Perspective Studies Division

2017

Construction of manufacturing sites in Russia and Finland. Establishment of foreign branch offices in Egypt and Vietnam. Expansion of product portfolio for treatment of autoimmune diseases.

Page 9: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

MANUFACTURING• Modern automated manufacturing

• Four manufacturing sites

• Fifth manufacturing site by 2019

Complying with international standards

Syrian Arab RepublicThe ministry ofHealth

9

• BIOCAD was granted with GMP Certificate from Brazilian regulatory body ANVISA

Page 10: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

MANUFACTURING SITESMOSCOW, PETROVO-DALNEYEBuilding 1

• Manufacturing of biological substances in E. coli

• Manufacturing of substances by chemical synthesis

• Manufacturing of drug products

Capacity:

1 kg/yearSubstances in E. coli

100 kg/yearSubstances by chemical synthesis

9 million vials/yearDrug products

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Page 11: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

MANUFACTURING SITESMOSCOW, PETROVO-DALNEYEBuilding 2

• Manufacturing of drug products

Capacity:

10 million/yearVials

8 million/yearPre-filled syringes

8 million/yearTablets

5 million/yearCapsules

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Page 12: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

MANUFACTURING SITESSAINT PETERSBURG, STRELNA

• Manufacturing of substances of monoclonal antibodies

Capacity:

240 kg/yearSubstances of monoclonal antibodies

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Page 13: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

MANUFACTURING SITESMOSCOW, LYUBUCHANY

• Pilot manufacturing for scale-up and technology transfer

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Page 14: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

R&D Center in Neudorf Special Economic Zone is a unique facility to implement the full life cycle of drugs: from development to full-scale manufacturing and distribution.

Modern manufacturing areas:

• Scale-up and transfer

• Production of biotechnology substances in mammal cells with fed-batch technology

• Production of biotechnology substances in mammal cells with continuous technology

• Production of drug products for injections.

To be launched by 2019.

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Page 15: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

R&D DIVISIONSFROM DEVELOPING GENETICALLY-ENGINEERED BIOTECHNOLOGY PRODUCTS TO CLINICAL STUDIES

BIOCAD has created its own infrastructure to develop innovative drugs: today, over 40 drugs are at various stages of development, of those – 37 biologics and 8 drugs of chemical origin.

31laboratories

650 employeesin R&D

$300 millioninvestments in R&D center

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Page 16: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

CHEMICAL DEPARTMENTMain objectives:

• Developing manufacturing technologies for drug substances

• Developing innovative chemical drug products

• Developing key generics for the Import-Substitution Program

Since 2014, BIOCAD has been implementing a project for creating innovative chemical drug products ChemNext.

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Page 17: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

5 Originaldrugs

• In silico modeling and modification of molecules

• Full development cycle

• High speed of synthesis and in vitro analysis of candidates

• Best-in-class > first-in-class

An innovative project for creating drugs from original chemical substances

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• Medical Department

• Marketing

• R&D

• Computational Biology Department

• Chemical Department

• Biological Studies Laboratory

• Experimental Biology Division

• Preclinical Studies Department

• Chemical Department

• Manufacturing

• Liquid Dosage Forms Department

• Clinical Studies Department

• Regulatory Affairs Division

• Ministry of Health

• Manufacturing

TASK DEVELOPING MOLECULE

PRECLINICAL STUDIES

SCALING UPTarget profile ofmolecule

Molecule for target profile

Efficacy and safety studies in animals

MANUFACTURINGREGISTRATIONCLINICAL STUDIES

Manufacturing technology

Efficacy and safetystudies in humans

Obtaining Marketing

Authorization

Manufacturedproduct SALES

DRUG LIFE CYCLE

Page 19: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

A unique project for creating novel monoclonal antibodies

>15 Original drugsat final stagesof development

• Unique amino acid sequences

• No non-human sequences

• High functional activity

• Pharmacological properties can be further improved by modifying Fc fragments

Page 20: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

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• Medical Department

• Marketing

• R&D

• Computational Biology Department

• Antibodies Development Division

• Biotechnology Processes Development Division

• Biological Studies Laboratory

• Biotechnology Processes Development Division

• Manufacturing

• Experimental Biology Division

• Preclinical Studies Department

• Clinical Studies Department

• Regulatory Affairs Division

• Manufacturing

TASK DEVELOPING MOLECULE

DEVELOPINGMANUFACTURING

TECHNOLOGYPRECLINICAL

STUDIES

Target profile ofmolecule

Molecule for target profile

MANUFACTURINGREGISTRATIONCLINICAL STUDIES

Manufacturing technology

Efficacy and safetystudies in humans

Obtaining Marketing

Authorization

Manufacturedproduct SALES

Efficacy and safety studies in animals

DRUG LIFE CYCLE

Page 21: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

ENRICHING THE LIBRARY WITH POTENTIALLY FUNCTIONAL MOLECULES

SELECTING THE FINAL CANDIDATE

SELECTING AND OPTIMIZATIONOF THE POOL OF CANDIDATE MOLECULES

CHOOSING THE TARGET

DEVELOPMENT UPSTREAM & DOWNSTEAM

PROCESSES

PHARMACEUTICAL DEVELOPMENT

PRECLINICAL STUDIES

CLINICAL STUDIES

PHAGE DISPLAY

HIGH-THROUGHPUT SCREENING

FUNCTIONAL CHARACTERISTICS

ANTI IL-6R

ANTI IL-17

High-throughput platform to maximize efficiency

INFORMATION CLOUDBioinformatic support, in silico methods,

statistical analysis

PRIDUCTIO

NO

FM

ON

OCLO

NAL

CELLLIN

E

CHOOSING THE TARGET PROFILE OF THE MOLECULE, PRODUCING THE TARGET PROTEIN

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TECHNOLOGOCAL PLATFORM TO DEVELOP MONOCLONAL ANTIBODIES

Page 22: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

BIOSIMILAR PIPELINE

Rituximab (Acellbia®)

Bevacizumab

Infliximab

Adalimumab

Interferon beta-1b

Enoxaparin

Development Phase IPreclinical studies

Phase III

Darbepoetin

Marketing Authorization

MONOCLONAL ANTIBODIES

RECOMBINANT PROTEINS

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BIO-BETTER PROJECTS (PEGYLATED DRUGS)

PEG-darbepoetin

PEG-Interferon beta-1a

Development Phase IPreclinical studies

Phase III Marketing Authorization

Phase II

Trastuzumab

Page 23: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

MOLECULAR GENETICSAND CELL BIOLOGY DEPARTMENT

• ANTIBODIES DEVELOPMENT DIVISION

• DIAGNOSTICS STUDIES LABORATORY

• BIOTECHNOLOGY PROCESSES DEVELOPMENT Main objectives of the department: DIVISION

• Developing innovative monoclonal antibodies

• Creating and engineering stable cell lines producing recombinant proteins for pharmaceutical use

• Constructing expression vectors

• Developing cultivation technologies for various types of bioreactors

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Page 24: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

BIOCHEMISTRY DEPARTMENT• IMMUNOCHEMISTRY DIVISION

• BIOCHEMISTRY DIVISION

Main objectives of the department:

• Developing technologies for isolating and purifying recombinant proteins for pharmaceutical use

• Creating pegylated proteins with prolonged effects

• Creating in-house test systems for measuring concentrations of proteins

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Page 25: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

PHARMACEUTICAL DEVELOPMENTAND TECHNOLOGY TRANSFER DEPARTMENT• ANALYTICAL DEVELOPMENT DIVISION

• LIQUID DOSAGE FORMS DIVISION

• SOLID DOSAGE FORMS DIVISION

• TECHNOLOGY TRANSFER DIVISION

• PILOT MANUFACTURE BIOTECHNOLOGY DIVISION

• ENGINEERING DIVISION

Main objectives of the department:

• Developing and validation of analytical and bioanalytical methods

• Analysis of physicochemical characteristics, pharmacokinetics, and pharmacodynamics of drug products and substances

• Developing formulations and manufacturing technologies for drug products

• Scaling up processes of manufacturing biological substances and drug products

• Developing pilot technologies of isolating and purifying substances

• Analytical and technology transfer

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Page 26: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

COMPUTATIONAL BIOLOGY DEPARTMENT

• DATA ANALYSIS DIVISION

• BIOINFORMATICS SOFTWARE DEVELOPMENT DIVISION

• STRUCTURAL BIOINFORMATICS DIVISION

• BIOINFORMATICS DIVISION

Main objectives of the department:

• Structural analysis and design of new molecules

• Mathematical support of laboratory tasks

• Statistical processing of big data volumes

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Page 27: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

PRECLINICAL STUDIESDEPARTMENT•EXPERIMENTAL BIOLOGY DIVISION

•PRECLINICAL STUDIES DIVISION

Main objectives of the department:

• Pharmacokinetics studies

• General toxicity studies (acute, sub-chronic, chronic)

• Specific toxicity studies (allergenic potential, immunotoxicity, reproductive toxicity)

• Pharmacodynamics studies

• Modeling human diseases in animals

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Page 28: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

CLINICAL STUDIES DEPARTMENTMain objectives of the department:

• Organizing and conducting clinical studies of all phases

• Organizing and conducting clinical studies of all phases through Contract Research Organizations (CROs)

BIOCAD is a leader among Russian companies by the number of approvals to conduct clinical studies. In 2017, the company received 18 authorizations to conduct clinical studies, 12 of them being authorizations for originator drugs. 28

Page 29: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

Ukraine

Colombia

RSA

Belarus Russia

India

Thailand

GA ADM PIb PD-1 PDb

ADM PIb PD-1 PDb

ADM

GA

INTERNATIONAL MULTICENTER CLINICAL STUDIES

Clinical studies

Acellbia® (rituximab)in non-Hodgkin lymphoma

Acellbia® (rituximab) in rheumatoid arthritis

TemozolomidCapecitabineFludarabine

Algeron®

Interferon beta-1a Extimia® Infliximab Enoxaparin Herticad®

Monoclonal antibody to IL-17

29

Avegra

Glatiramer acetateGA

AdalimumabADM

PEG-INF-beta1аPIb

PD-1PD-1

PEG – darbepoetin betaPDb

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INTERNATIONAL DEVELOPMENT

Page 31: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

Acellbia®INN: rituximab

Registered in Belarus, Georgia, Kazakhstan, Uzbekistan, Armenia, Bolivia, Honduras, Nicaragua, Morocco, India

Avegra® BIOCADINN: bevacizumab

Registered in Belarus, Morocco, Sri Lanka, Uzbekistan, Kazakhstan

Herticad®INN: trastuzumab

Registered in Belarus, Sri Lanka, Uzbekistan, Bolivia

INTERNATIONAL REGISTRATIONMONOCLONAL ANTIBODY BIOSIMILARS ARE KEY EXPORT PRODUCTS OF BIOCAD

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Page 32: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

PRODUCT PORTFOLIO

1. Leucostim®(INN Filgrastim)

2. Acellbia®(INN Rituximab)

3. Avegra® Biocad(INN Bevacizumab)

4. Herticad®(INN Trastuzumab)

Marketed original drugs:

1. Genferon®2. Genferon® Light3. Algeron®4. Extimia®

Our portfolio includes 45 marketed drugs, over 10 of them are biologics. More than 40 drugs are at various stages of development.

TOP 5 best sellers: Marketed biosimilars:

Awards:

Algeron®Best Novel Drug of Choice in Viral Hepatitis C (Russian Pharma Award 2015) and Best Novel Product (St. Petersburg Government Award).

Genferon Light®Winner in Beauty and Health nomination (Belarus Best Choice Award 2015).

Acellbia®

Herticad®

Taxacad®

Avegra®

Novotax®

5. Teberif®(INN interferon beta-1a)

6. Interferon beta-1b

1

2

3

4

5

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Page 33: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

PRODUCT PORTFOLIODRUG FOR THE TREATMENT OF CANCER AND AUTOIMMUNE DISEASES

Acellbia®INN: rituximab

Acellbia® is Russia’s first monoclonal antibody biosimilar,which is used to treat patients with non-Hodgkinlymphoma, chronic lymphocytic leukemia, rheumatoidarthritis, Wegener's granulomatosis, and microscopicpolyangiitis.

The product was launched in 2014.

358 741

365 233

people are diagnosed with non-Hodgkin lymphoma every year worldwide7715 new cases/year in Russia

people are diagnosed with chronic lymphocytic leukemia every year worldwide3264 new cases/year in Russia

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Page 34: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

PRODUCT PORTFOLIODRUGS FOR THE TREATMENT OF CANCER

Avegra® BIOCADINN: bevacizumab

The first Russian bevacizumab biosimilar.

Indicated in colorectal cancer, breast cancer, lung cancer, kidney cancer, glioblastoma, ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.

Launched in 2016

1 360 000

528 000

people are diagnosed with colorectal cancer every year worldwide60 000 new cases/year in Russia

women are diagnosed with cervical cancer every year worldwide16 000 new cases/year in Russia

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Page 35: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

PRODUCT PORTFOLIODRUGS FOR THE TREATMENT OF CANCER

Herticad®INN: trastuzumab

Herticad® is the first Russian biosimilar of the monoclonal antibody trastuzumab. Indicated in breast cancer and stomach cancer with HER2 overexpression.

Launched in 2016

1 700 000 women are diagnosed with breast cancer every year worldwide62 000 new cases/year in Russia

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Page 36: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

PRODUCT PORTFOLIODRUGS FOR THE TREATMENT OF CANCER

Leucostim® (filgrastim)

The first Russian granulocyte colony-stimulating factor. Indicated for the treatment and prevention of neutropenia associated with chemotherapy and therapy of HIV.

Extimia®INN: empegfilgrastim

The first Russian pegylated granulocyte colony-stimulating factor.Indicated for the prevention of neutropenia, one of the main complication of chemotherapy.

Imatinib

A potent tyrosine-kinase inhibitor usedin chronic myeloid leukemia and acutelymphoblastic leukemia..

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Page 37: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

PRODUCT PORTFOLIODRUGS FOR THE TREATMENT OF CANCER

Taxacad® (paclitaxel)

A chemotherapy agent indicated in lung cancer, breast cancer, and ovarian cancer.

Platicad® (oxaliplatin)

A platinum derivative indicated in colorectalcancer and ovarian cancer.

Novotax® (docetaxel)

A cytostatic from the taxane family. Indicatedin breast cancer, stomach cancer, and non-small cell lung cancer.

Gemcitar® (gemcitabine)

An anti-metabolite indicated in pancreatic cancer, lung cancer, and bladder cancer.

37

Page 38: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

PRODUCT PORTFOLIODRUGS FOR THE TREATMENT OF CANCER

Carboplatin

A platinum derivative indicated in ovarian cancer, lung cancer, cervical cancer, head and neck cancer, and bladder cancer.

Zolerix® (zoledronic acid)

A metabolism corrector from the bisphosphonate family. Indicated in bone metastases and osteoporosis..

Avomit® (granisetron)

An antiemetic, a serotonin receptor antagonist.Indicated for the prevention and treatment of nausea and vomiting associated with chemotherapy and radiation therapy.

38

Page 39: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

PRODUCT PORTFOLIODRUGS FOR THE TREATMENT OF CANCER

Temozolomide

An alkylating cytostatic agent indicated in the treatment of malignant glioma and melanoma.

Flugarda® (fludarabine)

An anti-metabolite indicated in B-cell hematological malignancies.

Cituvin (vinorelbine)

A cytostatic from the alkaloids family. Indicatedin non-small cell lung cancer, breast cancer, andprostate cancer.

39

Page 40: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

PRODUCT PORTFOLIO

Generic glatiramer acetate is indicated for the pathogenetictreatment of multiple sclerosis.

All manufacturing stages (including synthesis of the API) take place in Russia.

Launched in 2016

DRUGS FOR THE TREATMENT OF AUTOIMMUNE DISEASES

BIOCAD is the only company worldwide to produce three disease modifying anti-rheumatic drugs for the treatment of multiple sclerosis.

2 300 000 people in the world have multiple sclerosisPatients in Russia: 70 000

Russia is inside the top ten countriesby the number of patients with multiple sclerosis

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Page 41: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

PRODUCT PORTFOLIODRUGS FOR THE TREATMENT OF AUTOIMMUNE DISEASES

The first Russian biosimilar of interferon beta-1a. A commonly accepted standard in the first-line treatment of multiple sclerosis. Reduces the rate of relapses and slows down the speed of disability progression.

Launched in 2017

2 300 000 people in the world have multiple sclerosisPatients in Russia: 70 000

Russia is inside the top ten countriesby the number of patients with multiple sclerosis

41

Page 42: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

PRODUCT PORTFOLIODRUGS FOR THE TREATMENT OF AUTOIMMUNE DISEASES

Interferon beta-1b

Interferon beta-1b is the first Russian recombinant human interferon beta-1b for the treatment of multiple sclerosis.

Launched in 2009

Provided to Russian patients within the Seven High-Cost Nosologies Program (a state program for providing patients with orphan diseases with high-cost drugs) since 2010.

2 300 000 people in the world have multiple sclerosisPatients in Russia: 70 000

Russia is inside the top ten countriesby the number of patients with multiple sclerosis

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Page 43: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

PRODUCT PORTFOLIODRUGS FOR THE TREATMENT OF INFECTIONS

Genferon® (interferon alfa-2b + taurine + benzocaine)

A combined drug of recombinant interferon for thecombination treatment of urogenital infections.

Genferon® light spray (interferon alfa-2b + taurine)

Interferon in a convenient form for the prevention of acute respiratory viral infections.

Genferon® light (interferon alfa-2b + taurine)

A combined drug of recombinant interferon for the combination treatment of acute viral infections in children and urogenital infections in adolescents and pregnant women.

43

Page 44: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

PRODUCT PORTFOLIODRUGS FOR THE TREATMENT OF INFECTIONS

Algeron®

Algeron® is the first Russian pegylated interferon alfa with an original structure of the molecule.

Indicated in chronic hepatitis C.

Launched in 2013

2 800 000 people are diagnosed with chronic hepatitis C every year worldwidein Russia: 4335 new cases/year

44

Page 45: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

PRODUCT PORTFOLIODRUGS FOR THE TREATMENT OF INFECTIONS

Emtricitabine

A nucleoside reverse transcriptase inhibitor blockingthe enzyme required for HIV replication and used aspart of antiretroviral therapy.

Tenofovir

A nucleoside reverse transcriptase inhibitor blockingthe enzyme required for HIV replication and used aspart of antiretroviral therapy.

Zilacomb®

A fixed-dose combination of two nucleoside reverse transcriptase inhibitors blocking the enzymerequired for HIV replication, reducing viral load, and increasing counts of CD4+ lymphocytes.

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Page 46: OVERVIEW PRESENTATION - BrandBiocad · Launching Genferon®, an original drug for the combination therapy of urogenital infections. 2006 . Launching Leucostim® (filgrastim), the

BIOCADFOR AMBITIOUS AND TALENTED

1500 employeesin 8 countries

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HIGH NEED IN:

• Biotechnologists

• Research Associates

• Analytical Chemists

• Synthetic Chemists

Average age32years

Women/men 59%/41%

Average age33 years

Women/men 65%/35%

Average age35 years

Women/men 69%/31%

Average age32years

Women/men 51%/49%

R&D

40%

Manufacturing and quality

25%

S&M

11%

Supporting units

24%

HR STATISTICS

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HUMAN RESOURCE MANAGEMENT AT BIOCAD• A unique business culture to cultivate success

• Employees with high potential (“for the future”)

• Flexible organizational structure

• Personal responsibility of every employee

• Work with different generations

• Average age: 32 years

• Ability to apply knowledge in various areas

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CUB – Corporate University of BIOCAD

CUB aims in developing knowledge and skills of employees to achieve strategic goals of BIOCAD.

CUB includes:

Welcome center — adaptation and training for new employees Expert center — сteaching specific knowledge

Open center — teaching general knowledge

BIOCAD is a company based on knowledge. Knowledge is the only true source of competitive advantage.

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• BIOCAD Guest Club – meetings with celebrities

• Company Birthday Party

• Wake the Spring Up Party

• Meetings with BIOCAD President

Every year, BIOCAD creates many corporate events for the employees to know each other better and improve the efficiency of work.

• Family Day

• Victory Day

• New Year

• Children’s Day

CORPORATE EVENTS

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NOBEL PRIZE WINNERS VISITING BIOCAD

2014

Zhores AlferovA Nobel Prize laureate in Physics for the

development of semiconductor heterostructures used in high-speed- and optoelectronics

2015

James WatsonA Nobel Prize laureate in Biology for discoveries

concerning the molecular structure of nucleic acids and its significance for information transfer

in living material

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NOBEL PRIZE WINNERS VISITING BIOCAD

2016

Arieh WarshelA Nobel Prize laureate in Chemistry

for the development of multiscale models

for complex chemical systems

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2017

Aaron CiechanoverNobel Prize in Chemistry for characterizing

the method that cells use to degrade and recycle proteins using ubiquitin

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COLLABORATION WITH UNIVERSITIESBIOCAD COLLABORATES WITH 22 LEADING RUSSIAN UNIVERSITIES AND SUPPORTS PROMISING STUDENTS

St. Petersburg State Chemical Pharmaceutical Academy

Kazan State Medical UniversitySt. Petersburg Alferov Academic University

Mendeleev Chemical Technology Universityof Russia

St. Petersburg Pavlov State Medical University

St. Petersburg State University

• St. Petersburg State Technology Institute

• ITMO University, St. Petersburg

• POLITECH, Peter the Great St. Petersburg Polytechnic University

• Irkutsk State Medical University

• Voronezh State Engineering University

• Sechenov First State Medical University

• Skolkovo Science and Technology Institute

Novosibirsk State University

Siberian State Medical University

Moscow State University

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TALENT POOL.EDUCATIONAL PROJECTS• Collaboration with St. Petersburg Chemical Pharmaceutical Academy

• Collaboration with Alferov Academic University

• Collaboration with other universities

• Activities in high schools

• Sirius Educational Project

• BIOCUP.PRO Educational Project

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SINCE 2015

COLLABORATION WITH IOFFE PHYSICS AND TECHNICS HIGH SCHOOLOF RUSSIAN ACADEMY OF SCIENCES

EDUCATIONAL PROJECTS

Leading specialists of BIOCAD give lectures at Biomedical Informatics Course for high school students at the Ioffe Physics and Technics High Schoolof Russian Academy of Sciences. BIOCAD opened a chemistry class, where its specialists give lectures, and students do research in laboratories and present their results in international conferences.

BIOCAD PROMOTES BIOINFORMATICS,AND THE MOST ACTIVE STUDENTS TAKE PART IN REAL PROJECTS

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SINCE 2012

RECOMBINANT PROTEINSTECHNOLOGY DEPARTMENTIN ST. PETERSBURG CHEMICAL PHARMACEUTICAL ACADEMY

Educational projects

BIOCAD participates in preparing high-qualified specialists in technologies for producing recombinant proteins for pharmaceutical use.

Over 100 graduates of Chemical Pharmaceutical Academy work for BIOCAD

Every year, BIOCAD hires10–15 graduates

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SINCE 2018

TRAINING CLASSROOM AT BIOCAD’S FACILITIES

Educational projects

BIOCAD’s leading specialists deliver a special course named “Biomedical Information Science” intended for students from senior classes. Students from Physical Technical School of the Academic University of the Russian Academy of Sciences (PTS), Physical and Mathematical School No. 30 and President’s Physical and Mathematical School No. 239 were the first to subscribe to the course. The course is delivered on a weekly basis in the center of Saint Petersburg at a new training classroom of BIOCAD.

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Department of Molecular and Cell Biotechnology in Pushchino

Образовательные проекты

Engagement and training of your scientists is one of long-term strategic directions for development of BIOCAD’s scientific and technology base. The department in Pushchino State Institute of Natural Sciences is company’s large-scale project pertaining to higher education and postgraduate training.

10 students 14 teachers from the staff

student allowance 7200 rubles

Project budget 1 250 000 per year

Educational projects

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EDUCATIONAL PROJECTSCOLLABORATION WITH ALFEROV ACADEMIC UNIVERSITY

‘COLLABORATION BETWEEN ACADEMIC UNIVERSITY AND BIOCAD IS A GOOD EXAMPLE OF SUCCESSFUL INTERACTION BETWEEN SCIENCE AND BUSINESS’

Zhores Alferov, Nobel Prize Laureate

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BiotechClubScientific development platform: uniting the academic environment and industry.

Building a bridge between the company and scientific organizations for further collaboration: commercializing scientific research institutes’ development projects, using the stock of instruments within the framework of BIOCAD projects, raising the level of graduates’ skills.

300 participants more than 40 OL in oncology, biological information science, genetics

Representatives from the most relevant organizations –Russian National Medical Research University named after Pirogov, National Medical Research Center named after Almazov, Skolkovo, Moscow State University, Novosibirsk State University, Ministry of Defence, Scientific Research Institute of Oncology named after Petrov, Scientific Research Institute of Cytology.

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PARTNER PROJECTS

BIOCAD developed patientsupport programs

Grants for resident physicians

Providing grants for nine resident physicians in oncology

Zhivu Ne Naprasno Fund and SCREEN project

The first individual prophylaxis system in Russia and worldwide

Over 5000 people underwent tests during summer festivals in 2016

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* Foundation for cancer prevention

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SOCIAL PROJECTS

BIOCAD developed patientsupport programs

Mirodin

A social network for patients with chronic hepatitis C. In the future –also for patients with other socially significant diseases

www.mirodin.com

Betalife

A service program to support patientswith multiple sclerosis

Affordable treatment to children

A philanthropic program providingchildren with chronic neutropeniawith Leocostim®

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BIOCAD IS A RELIABLE PARTNER OF THE STATE• Projects of BIOCAD comply with:

Russian Pharmaceutical Industry Development Strategy PHARMA 2020, developed by Ministry of Industry and Trade of Russia

• Government Decree 157 (17 March 2010) “Organizing pilot manufacturing of drug substances and products of monoclonal antibodies to substitute high-cost foreign products” and Government Decree 320 (25 April 2011) “Implementation of the project on organizing pilot manufacturing of drug substances and productsof monoclonal antibodies”

• Products of BIOCAD are of high social significance and are included in Vital and Essential Drug List

• Owing to products of BIOCAD, prices for oncology drugs during electronic tenders were decreased to 85.5%, so 14 thousand more Russian patients will receive therapy at no additional costs for the budget if compared with purchasing foreign products.

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КОМАНДА

Dmitry MorozovPresident

Alexandr GrachevVice-President, Manufacturing

Alexandra GlazkovaVice-President,

HR, PR, Corporate Marketing

Oleg PavlovskyVice-President,

Marketing and Sales

Roman IvanovVice-President, R&D,

International Business Development

Evgeny PochkaevVice-President, Information Technology

and Operational Development

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PEOPLE ABOUT BIOCAD

Dmitry MedvedevThe Chairman of the Government of the Russian Federationwww.government.ru/news/31392/

'On February 15, at the plenary session (during the Russian Investment Forum 2018 in Sochi) Biocad’s Director Dmitry Morozov told how his company would develop and how they would compete. And I specially set a stress on the following: our pharmaceutical industry is growing at the annual rate of 25%. We had never seen such a thing before. What did we do before? We simply bought currency and purchased tablets abroad. In addition, there was a fairly big number of intermediary agents who naturally earned their living on that. But today this is investing in our science (everything is very complicated over there, today the entire pharmacology is a highest-level area of knowledge, applied knowledge, from a point of view of scientific approach), in manufacturing, packaging and, subsequently, sales. And all that is working. I am very glad that we are having more and more such industries in our country.’

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PEOPLE ABOUT BIOCAD

Sergey ThybDeputy Minister of Industry and Trade of the Russian Federationwww.government.ru/news/12433/

‘Several recent years saw the active formation of infrastructure, accompaniedby the modernization process. It brought large investments of private companies to this sector in the last 4 or 5 years. All these funds were allocated to innovative territorial clusters established in the Russian Federation. The Russian Government, in its turn, also contributes to the foundation of centers for the developmentof medicinal products and medical devices, via the State Program for the Pharmaceutical and Medical Industry Development with the help of leading Russian universities.’

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PEOPLE ABOUT BIOCAD

Veronika SkvortsovaMinister of Health of the Russian Federationwww.government.ru/news/12433/

'At the opening of the first Russian R&D center for developing advanced therapies, Veronika Scvortsova said, ‘Most pioneer areas of the modern pharmaceuticals, which allow personalized pharmacogenetics, targeted delivering of drugs without altering the whole body – all this has come true. And the BIOCAD’s laboratories are state-of-the-art in Russia. BIOCAD is the leading Russian pharmaceutical company in development and manufacturing of drugs for most complex diseases. BIOCAD’s R&D is one of the strongest in Russia thanks to its human resources as well.The first two innovative drugs developed by BIOCAD (for the treatment cancer and autoimmune diseases) are now being registered or studied in clinical trials.’

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PEOPLE ABOUT BIOCAD

Arkady DvorkovichDeputy Premier Minister of the Russian Federation, during a meetingof the Presidium of the Presidential Council for Economic Modernisation and Innovations of Russiawww.government.ru/news/12433/

‘If we talk about modern pharmaceutical manufacturing, Russia has some globallycompetitive manufacturing sites. We have Generium, Biocad, KhimRar, and others.They sell their high-quality products both in Russia and worldwide.’

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THANK YOU!