n a n o l e k r u s s i a n p h a r m a c u e ... - jefferies · • russia is at par with rest of...

November, 2014

N A N O L E K

-

R U S S I A N

P H A R M A C U E T I C A L

C O M P A N Y

-

O V E R V I E W

S U M M A R Y

NANOLEK aimed to become one of the leading Russian

pharmaceutical companies by 2018

2

NANOLEK is a biopharmaceutical company that sets up a state-of-the-art manufacturing facilities with

portfolio focus on prescription drugs for high disease burden and priority therapeutic areas: vaccines,

oncology, rheumatology, orphan drugs, antiretroviral products

Portfolio structure

Sales pattern, 2018, forecast 2014

Well-balanced portfolio: • Vaccines;

• Biosimilars;

• Orphan drugs;

• ARV and others;

Manufacturing facility

Full compliance with best industry practice in respect to labour and environmental standards

Full EU GMP compliance

Ownership structure The company is 51% owned by Russian private shareholders and 49% - by state investment fund JSC Rusnano.

C O N T E N T

3

Russian market overview

Manufacturing

Portfolio Strategy

Sales & Distribution

Team

Value proposition

M A R K E T

O V E R V I E W

In 2014 Russian pharmaceutical market is about

to reach USD18 bln. level.

Key market drivers: new categories expansion,

demand for modern treatment, governmental

programs.

4

2,3

7,7

14,7

18,0

0,3 0,8

3,3

4,8

5,0 2,7

3,0 22.2

Medicines insurance (2018)

10%

6%

4.8

6.6

Retail

Hospital

segment

DLO/7N

Insurance

28.0

DLO introduction

7N

introduction

2000 2005 DLO 2010 DLO/7N 2016 2020

USD Bln.

4.0 1.7

1.3

13.0

M A R K E T T R E N D S :

L O C A L I Z A T I O N A N D R & D

5 SOURCE: Russia Ministry of Trade and Finance “Strategy for development of pharmaceutical sector

to 2020"

20 50

80 50

100% =

Local

Foreign

2020

100

2010

100 100% =

Originals

Generics

Branded

generics

20201

100

2010

100

LOCAL R&D

• Establish innovative local

pharmaceutical industry

• Support competitiveness

of domestic companies

LOCAL MANUFACTURING

• Reduce share of import

• Develop exports based on

perception of high quality and

effectiveness

Government wants to grow local

manufacturers …

… as well as increase the share

of innovative drugs

15% margin preference + blocking governmental purchases for international

products with domestic competition / 30% in terms of full-cycle production

M A R K E T O V E R V I E W :

S U M M A R Y

• Government will continue investing into healthcare, despite the

financial turbulence

• “PHARMA 2020” localization push will create new Russian

pharmaceutical manufacturing infrastructure

• Federal and private investment into R&D will keep growing

• Government investment in healthcare will go along with cost

control measures

• Standards of production and quality of drugs tend to rise

constantly

• Industry consolidation (production, distribution, retail): future

belongs to large companies.

6

C O N T E N T

7


Manufacturing

Portfolio Strategy


Team

Value proposition

N A N O L E K

S T R A T E G Y

MARKET

OPPORTUNITIES

GOVERNMENT

SUPPORT

WIN-WIN SITUATION

FOR NANOLEK

8

Low share of

Russian products:

imported drugs sales

deliver 70% of the

market value in 2012

Less than 10%

manufacturing facilities

are fully or partially

GMP compliant

Government

purchasing sector

to grow by 2017

up to 40% of

market

Low share of innovative

drugs

Branded generics – 50%

Generics - 25%

Originals – 25%

PHARMA 2020:

Unique GMP

manufacturing

facility in Russia

Focus on government

sector.

NANOLEK Revenue 2017:

government purchase 45%

hospital segment - 43%

retail – 12%

• Increase share of Russian products: 50% in 2020

• Oblige GMP compliance starting Jan 1, 2014

• Increase financing of healthcare programs

• Increase the share of innovative drugs: 50% in

2020

Substantial growth

• Annual vaccine market is Russia is about

100-110 mln doses or 400 USD mln

• Spectacular growth rate: 10-15% per year

versus 5-7 % for pharmaceuticals (WHO,

Worldwide)

• Russia has a large number of locally

produced vaccines, but most of it are being

manufactured not according to GMP

standards

9

421408

389

350

312

2009 2010 2011 2012 2013

+14%

Russia

n v

accin

e m

ark

et,

US

D m

ln

R U S S I A N V A C C I N E

M A R K E T O V E R V I E W

• The Russian vaccine market is expected to

grow 10-12% annually and reach the volume

of 600-700 USD mln by 2017

Russia

Germany USA

• Tuberculosis

• Diphteritis

• Pertussis

• Tetanus

• Measles

• Parotiditis

11

17 15

VACCINES

VACCINES VACCINES

• Pneumococcus

• Meningococcal

• Varicella

• HPV

• Hepatitis A

• Rotavirus

• Flue

• Hepatitis В

• Poliomyelitis

• Haemophilus influenzae

Vaccination Calendar

Substantial growth

• Russia is at par with rest of Europe in terms

of evolution of Specialty medicine, but still is

8%-10% behind by structure;

• The introduction of DLO in 2005 has resulted

in the higher access of expensive specialist

medicine like those for Oncology;

10

$3.6 bln.

2004 2014

$18.3 bln.

R U S S I A N

B I O L O G I C A L S M A R K E T

• In 2008 the introduction of the “Seven

nosologies” program further increased

access of the most expensive specialist

treatment like hemophilia, cystic fibrosis,

Gaucher disease, myeloid leukemia and

multiple sclerosis

88%

73%

12% 27% Specialty

Traditional

SOURCE: IMS Health MIDAS Jun 2014, Rx bound

$3.6 bln.

2004 2014

$18.3 bln.

91% 78%

9% 22% Biologics

None-

Biologics

• Very limited number of producers are trying

to play on the Russian biosimilars market

leaving wide scale of opportunities.

Highly potential drugs in several therapeutic categories

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Vaccines

Biosimilars

Orphan drugs

ARV

CNS & CVS

Therapeutical

category

Total number of

products

7

5

3

5

17

Key drugs in the

category

- HEP B

- IPV

- Cell-based FLUE

- Filgrastim

- Rituximab

- Interferon beta 1A

- Idursulphase

- Tenofovir

- Leviteracetam

- Clopidogrel

- Nebivolol

- Rosuvastatin

- Pregabalin

Launch

year

- Y2015 (MA obtained)

- 4Q2015 (Clinical trials)

- Y2018 (Pre-clinical trials)


- Y2018 (Clinical trials)









P O R T F O L I O

P R O D U C T S

F U T U R E

P O R T F O L I O

D E V E L O P M E N T

Combining R&D and manufacturing potential of Kirov

region

12

Science«core» of cluster

Production «core» of cluster

Biological faculty of

Vyatskiy state university

R&D Institute of Microbiology of

Defense Ministry

Kirovskayamedical

academy

Vyatskaya state agricultural

academy

Biopharmaceuticalcomplex NANOLEK

Biopharmaceutical veterinary complex

«AGROVED»

Production of immuno biology

drugs «PHARM Defense»

Potential members

ALSI Pharma

АВВА RUS

Kirovskiy Bio-Chemical factory

Omutninskaya science-industrial factory

Kirovsky R&D Institute of hematology and blood transfusion

ROSPLAZMA

Research & Development center

C O N T E N T

13


Manufacturing

Portfolio Strategy


Team

Value proposition

P R O D U C T I O N

F A C I L I T Y

S N A P S H O T

Main parameters:

• Location: Russia, Kirov Region (1000

km East of Moscow)

• Total investment: USD 100 MM

• Total land area: 14 hectares

• Total facility area: 28,000 sq.m.

• Number of employees in 2015: 250

Annual output:

• 1 bln. tablets/capsules

• 35 mln. vials;

• 42 mln. prefilled syringe;

14

Localization options:

• Primary & Secondary packaging

• Fill & Finish

• Fermentation synthesis of

biopharmaceutical products

PHARMACEUTICAL

QUALITY SYSTEM

F U L L - C Y C L E

G M P - C O M P L I A N T

F A C I L I T Y

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QUALITY ASSURANCE

QUALITY CONTROL

• Design was made by leading European engineering company GMproject

• All production buildings are already constructed; inner engineering systems are being installed

• Solid dosage forms manufacturing license – 4Q 2014.

• Biologicals manufacturing license – 2Q 2015

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S C H E D U L E O F

I N S T A L L M E N T S

Facilities installment is synchronized with schedule of portfolio

registration, sales growth and state requirements to localization

.

Stage 0:Construction

Stage 2:Full cycle of solid forms

Solid dosage forms

Cytotoxic

Biologicalforms

Site Preparation :

Purchase of groundplot and its formation

Engineering sitepreparation, inclinternal and externalnetworks (canalization,energy)

Construction ofproduction workshops

Construction of none-production workshops

Construction and startof energy generatingunit

Full cycle production line №1

Granulation Tabletizing and

capsule filling Labelling, pre-

packing, packaging

Fill finish Spray freeze drying Filling in flasks Filling in prefilled

syringes Inspection Labelling, filling,

packaging

Full cycle production –line №2 and №3



packing, packaging

Full cycle of solid forms:



packing, packaging

Soft dosage forms

Outsourced manufacturing

Phase 1Solid forms – full cycle

Phase 2Fill finish bilologicals

Stage 1: Set up of production

July 2012 –Dec. 2013

Dec. 2013 -Dec. 2014

2016 -2017

Feb. 2014 -June 2015

Stage 3: Full cycle of biologicals

Full cycle of injection dosage forms

Full cycle –line № 1

2018 -2020

Phase 1 Phase 2

manufacturing of cell-based vaccines manufacturing of recombinant proteins protein purification

Full cycle –line № 2

2020 -2022

Secondary packaging of solid and injection forms

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C O N S T R U C T I O N :

P H O T O U P D A T E

Pension Fund of Russia

3Q2012

3Q2014

1Q2014

A few days before operations. Licence acquisition -

December 2014; mass production Q2 2015

M A N U F A C T U R I N G

F A C I L I T Y F O R S O L I D

F O R M S

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Stages

Q2 2015 Full cycle production Line #1

• Granulation

• Tableting and Capsule filling

• Labeling, Pre-packing, Packing

Capacity: 500 mln tablets and 100 mln capsules

Q3 2016 Full cycle production Line #2 & #3

• Granulation

• Tableting and Capsule filling

• Labeling, Pre-packing, Packing

Full Capacity: 1 bln tablets and 400 mln capsules

M A N U F A C T U R I N G

F A C I L I T Y F O R

B I O L O G I C A L S

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Stages

2Q2015 (Fill-Finish)

• Filling line, 1 ml syringes, in pharmaceutical isolator • Filling line, vials 2R, 6R, 8R, 15R и 30R

• Spray-freeze drying in pharmaceutical isolator

Services: aseptic liquid filling, lyophilization, QC test, label & packaging

2018 (Wall-to-wall, incl. API manufacturing)

• 1st production site: manufacturing of cell-based vaccines • 2nd production site: manufacturing of recombinant proteins (produced in

E. coli and mammalian cells) Full capacity: 42 mln prefilled syringes/ 35 mln vials per year

C O N T E N T

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Manufacturing

Portfolio Strategy


Team

Value proposition

S A L E S C H A N N E L S

21

Focus on public purchases leads to a limited number of

professional sales staff securing their presence in large

cities.

Nanolek Sales Forecast for 2015: USD 50 mln.

Moscow

Saint-Petersburg

Novosibirsk

Ekaterinburg

Rostov

Stavropol

Krasnodar

Nizhniy Novgorod

TumenPerm

Samara

Krasnoyarsk

Irkutsk

Ufa

Saratov

- Regional manager

- Key account manager

15 employees 20 employees 40 employees

12 cities 17 cities 20 cities

Y2014 Y2015 Y2016

Development of sales department

S A L E S A N D

D I S T R I B U T I O N

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Distribution is arranged via largest national and regional wholesalers who participate in public

tenders, provide for with Sales Force team Nanolek’s portfolio presence in pharmacy chains and for

marketing support.

Distributors

F1-A*

Protek

Katren

CIA International

F1-B

Rosta

Alliance Healthcare

F1-C

Biotek

F2-A

Oriola

Pulse

Imperia-Pharma

PharmComplex

BSS

PharmImpeks

Euroservice

ProfitMed

F2-B

Irvine-2

Godovalov

Lekrus

Intermedservice

North-West

Baltimor

F2-С

Medexport

Agroresources

Pharmazevt

Nadezhda-Pharm

F3-A

Pharm-SKD

Zdravservice

Vitta Company

Volgopharm

LipetskFormation

Avikon-Med

Medintorg

F3-B

Medservice-

Region

Bolear

Medical-

Consulting

F2-С

Vostok-Pharm

Donskoy

Hospital

Regional pharmacy chains Delivery to hospitals Delivery to regions

National

pharmacy

chains

А5 Group

Rigla

Pharmacy network

36,6

Implozia

Pharmakor

SoyuzFarma

Alfega Network

PharmaImpeks

Rainbow

Oriola

Classic

Vita

Pharmland

Stolichnaya network

Doctor Stoletov

Samson-Pharma

Opeka

First Aid

Sound of health

Nevis

A.V.E. group

NANOLEK’s COMMERCIAL NETWORK

National Regional Local

Well-known and reliable member of Nanolek group

E P I D B I O M E D - I M P E X

23

Well-established distribution company for

immunobilologicals:

25 mln. USD annual turnover (100% regional

tenders and hospitals)

Fully equipped “cold chain” logistics system

Experienced Import and Client Service team

250 + Loyal customers

Long-terms relationship proved by agreements

with leading manufacturing companies

150+ governmental contacts on purchases have

been performed;

Up to 35% of Pandemic Vaccines market;

15% of Local Flu Vaccines market

Bacteriophage

Pro

bio

tics

Albumines

Chemical Formulations

Other 8%

Serums

Vaccines

Immunoglobulins

16%

14%

33%

6%

8%

11%

4%

Portfolio Structure

http://epidbiomed.ru/

C O N T E N T

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Manufacturing

Portfolio Strategy


Team

Value proposition

T E A M

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Nanolek has a professional team which has not only a significant industry experience, but also

experience in solving similar problems facing the company in the leading Russian and foreign

pharmaceutical companies

Mikhail Nekrasov

General Manager

1997 –founder and Head of «Makiz Pharma».

2002- «Makiz Pharma» - Russia's first pharmaceutical factory,

designed according to GMP standards.

2007- During 5 years led «Makiz Pharma» to Top 5 Russian

drugmakers by revenue and sold it to «STADA CIS» for € 125

million.

2007 - Founder and Head the group of companies

«EPIDBIOMED» - a major distributor and immuno-diagnostic

products and medical consumables.

Svetlana Efimova

Head of TT/ Procurement Department

2004 - 2005 –Procurement manager at "Vedis-Steel».

2005 - 2007 -Procurement Manager at «New Line Fabriк».

2007 - 2010 -Head of procurement department at «Акrihin».

2010 - 2014 - Head of procurement department at «R-

Pharm».

Vladimir Kutyrov

Commercial Director

1998 – 2003 – Regional sales manager at F.Hoffmann-La

Roche

2003 - 2007 – Regional sales manager at «AstraZeneca».

2007 - 2009 – Business Unit Director (Oncology) at OJSC

Verofarm - Russian production company.

2009 - 2014 – Commercial Director at Akrihin.

14 years

10 years

16 years

Doctor of Medical Sciences, Academy of

Natural Sciences

Andrey Belov 18 years

Head of Production Department

1995 - 2007- Electronics Engineer at «Immunopreparat».

2001- 2007- Mechanic at «NPO" Microgen».

2007 - 2011- Deputy of General Manager/ Head of

production department at «Medical and industrial equipment

Factory».

2011 – 2013 - Head of solution & lyophilizate production

area (block) at «R-Pharm».

http://www.akrikhin.ru/

http://www.newline-fabrics.ru/

http://www.microgen.ru/

http://www.akrikhin.ru/

T E A M

Svetlana Gogoleva

Head of Portfolio development

2006-2007 Project manager at

«Nielsen».

2008-2012 гг. – Adviser at «IMS

Consulting Group». 5 years

Eugenie Barinov,

ACCA Financial Director

2004-2007 - Senior adviser at

PricewaterhouseCoopers.

2008-2011 - Audit manager at

KPMG.

2011-2013 - Financial director

Russia&CIS at «RATIONAL

GmbH» 10 years

Maria Pavlova

Head of HR department

2003-2006 - HR manager C&B

department at «Rostelecom».

2006-2010 -Head of recruitment

department at « Actavis».

2010-2012 -Head of HR

department at «Actavis» . 12 years

Ilya Vyazovsky

Medical Director

2004-2007 -Clinical operations

manager at «Servier».

2007-2013 -Clinical operations

manager at «Amgen».

14 years

Vladislav Popov

Head of Legal Development

2004-2005 – law consultant in BRIT

Company.

2005-2014 - Head of business

processes support department in

URALSIB Bank;

10 years

Alfia Gabidova

Head of Regulatory Affairs Department

2001-2013- Senior positions in the

Ministry of Health of the Russian

Federation:

- Drugs certification State quality

control;

- Drugs production State quality

control; 20 years

Svetlana Shabalova

Head of Quality department

2001-2008 гг. – Deputy Head of the

Quality Control Laboratory

«Farmaks».

2008-2011 -Head of Quality

Assurance at «Rosplazma»;

2011-2013 гг. – Head of Quality

department at «R-Pharmм». 14 years

Alexander Fuchizhi

Site Chief / Chief Engineer

1995-1996 – engineer of production

line «Ferein».

1999-2009 -Head of technical

development department

«Bryntsalov- А».

2009-2012 – Deputy of technical

director «Binenergy». 18 years

Pokrovsky Vadim,

PhD Business Development Manager

2012 – 2013 гг. – Senior analyst

«Biofund RVC».

2006 – current time – candidate for

doctor degree in Oncology center

RONC named N.N.Blokhina. 14 лет

26

C O N T E N T

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Manufacturing

Portfolio Strategy


Team

Value proposition

T E C H N O L O G Y

T R A N S F E R : C H A L L E N G E

F O R N A N O L E K

Keen interest in the Russian market

Ability to conduct clinical trials in Russia

Ability to out-license product for Russia and CIS

Past experience and accomplishments of the company

What are we looking for?

Collaboration with companies aimed to win on the Russian market

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M A R K E T A C C E S S : K E Y

C O M P E T I T I V E

A D V A N T A G E

Strategy and vision

Manufacturing capabilities

Regulatory affairs

Market access

What are our value proposition?

Our company has people, facilities, experience and necessary resources to provide market access for the

long term and efficient expansion of the product on the Russian market

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T H A N K Y O U !

n a n o l e k r u s s i a n p h a r m a c u e ... - jefferies · • russia is at par with rest of...

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