November, 2014 - Jefferies
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
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
November, 2014
SUMMARY
NANOLEK aimed to become one of the leading Russian
pharmaceutical companies by 2018
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 Manufacturing facility
Sales pattern, 2018, forecast 2014 Full compliance with best industry practice in
respect to labour and environmental standards
Full EU GMP compliance
Well-balanced portfolio:
• Vaccines;
• Biosimilars;
• Orphan drugs;
• ARV and others;
Ownership structure The company is 51% owned by Russian private
shareholders and 49% - by state investment fund
JSC Rusnano. 2
CONTENT
Russian market overview
Portfolio Strategy
Manufacturing
Sales & Distribution
Team
Value proposition
3
In 2014 Russian pharmaceutical market is about
MARKET to reach USD18 bln. level.
Key market drivers: new categories expansion,
OVERVIEW demand for modern treatment, governmental
programs.
USD Bln.
Insurance
6%
Medicines 28.0
DLO/7N insurance (2018)
6.6
Hospital
segment 22.2 3,0
Retail 10% 2,7 5,0
7N 4.8
introduction 4,8
13.0
18,0
DLO introduction 3,3
14,7
4.0
1.7 0,8 7,7
0,3 2,3
1.3
2000 2005 DLO 2010 DLO/7N 2016 2020
4
MARKET TRENDS:
LOCALIZATION AND R&D
Government wants to grow local … as well as increase the share
manufacturers … of innovative drugs
100% = 100 100 100% = 100 100
Branded
50 generics
Foreign 80
Generics
50
Local 20 Originals
2010 2020 2010 20201
LOCAL MANUFACTURING LOCAL R&D
• Reduce share of import • Establish innovative local
• Develop exports based on pharmaceutical industry
perception of high quality and • Support competitiveness
effectiveness of domestic companies
15% margin preference + blocking governmental purchases for international
products with domestic competition / 30% in terms of full-cycle production
SOURCE: Russia Ministry of Trade and Finance “Strategy for development of pharmaceutical sector 5
to 2020"
MARKET OVERVIEW:
SUMMARY
• 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
CONTENT
Russian market overview
Portfolio Strategy
Manufacturing
Sales & Distribution
Team
Value proposition
7
NANOLEK
STRATEGY
Low share of Less than 10%
Russian products: manufacturing facilities
imported drugs sales are fully or partially
MARKET deliver 70% of the GMP compliant
market value in 2012
OPPORTUNITIES
Government Low share of innovative
purchasing sector drugs
to grow by 2017 Branded generics – 50%
up to 40% of Generics - 25%
market Originals – 25%
• Increase share of Russian products: 50% in 2020
GOVERNMENT • Oblige GMP compliance starting Jan 1, 2014
PHARMA 2020: • Increase financing of healthcare programs
SUPPORT
• Increase the share of innovative drugs: 50% in
2020
Focus on government Unique GMP
WIN-WIN SITUATION sector. manufacturing
FOR NANOLEK NANOLEK Revenue 2017: facility in Russia
government purchase 45%
hospital segment - 43%
retail – 12%
8
RUSSIAN VACCINE
MARKET OVERVIEW
Substantial growth
• Annual vaccine market is Russia is about • The Russian vaccine market is expected to
100-110 mln doses or 400 USD mln grow 10-12% annually and reach the volume
of 600-700 USD mln by 2017
+14% • Russia has a large number of locally
Russian vaccine market, USD mln
421 produced vaccines, but most of it are being
408
389 manufactured not according to GMP
350 standards
312
Vaccination Calendar
Russia
• Tuberculosis
• Diphteritis
• Pertussis • Flue
•
•
Tetanus
Measles
•
•
Hepatitis В
Poliomyelitis
11
• Parotiditis • Haemophilus influenzae
VACCINES
Germany USA
2009 2010 2011 2012 2013
• Spectacular growth rate: 10-15% per year • Pneumococcus
15 • Hepatitis A 17
• Meningococcal • Rotavirus
versus 5-7 % for pharmaceuticals (WHO, • Varicella
• VACCINES VACCINES
Worldwide) HPV
9
RUSSIAN
BIOLOGICALS MARKET
Substantial growth
• Russia is at par with rest of Europe in terms • In 2008 the introduction of the “Seven
of evolution of Specialty medicine, but still is nosologies” program further increased
8%-10% behind by structure; access of the most expensive specialist
$18.3 bln.
treatment like hemophilia, cystic fibrosis,
$3.6 bln.
Gaucher disease, myeloid leukemia and
12% multiple sclerosis
Specialty 27%
$3.6 bln. $18.3 bln.
9%
Biologics 22%
88%
73%
Traditional
91%
78%
None-
Biologics
2004 2014
• The introduction of DLO in 2005 has resulted 2004 2014
in the higher access of expensive specialist
medicine like those for Oncology; • Very limited number of producers are trying
to play on the Russian biosimilars market
leaving wide scale of opportunities.
SOURCE: IMS Health MIDAS Jun 2014, Rx bound 10PORTFOLIO
PRODUCTS
Highly potential drugs in several therapeutic categories
Therapeutical Key drugs in the Launch Total number of
category category year products
- HEP B - Y2015 (MA obtained)
Vaccines - IPV - 4Q2015 (Clinical trials) 7
- Cell-based FLUE - Y2018 (Pre-clinical trials)
- Filgrastim - Y2015 (MA obtained)
- Rituximab - Y2018 (Clinical trials) 5
Biosimilars - Y2018 (Clinical trials)
- Interferon beta 1A
- Idursulphase - Y2016 (Clinical trials)
Orphan drugs 3
- Tenofovir - Y2016 (Clinical trials)
ARV 5
- Leviteracetam - Y2015 (MA obtained)
- Clopidogrel - Y2015 (MA obtained)
- Nebivolol - Y2015 (MA obtained) 17
CNS & CVS
- Rosuvastatin - Y2015 (MA obtained)
- Pregabalin - Y2015 (MA obtained)
11FUTURE
PORTFOLIO
DEVELOPMENT
Combining R&D and manufacturing potential of Kirov
region
Science Production
«core» of cluster «core» of cluster
Research &
Biological Development center
faculty of
Vyatskiy state Biopharmaceutical
university complex NANOLEK
R&D Institute of
Microbiology of
Defense
Ministry
Biopharmaceutical
veterinary complex
«AGROVED»
Kirovskaya Potential members
medical
academy ALSI Pharma
АВВА RUS
Kirovskiy Bio-Chemical factory Production of
Omutninskaya science-industrial immuno biology
Vyatskaya state drugs
factory
agricultural «PHARM Defense»
academy Kirovsky R&D Institute of
hematology and blood transfusion
ROSPLAZMA
12CONTENT
Russian market overview
Portfolio Strategy
Manufacturing
Sales & Distribution
Team
Value proposition
13PRODUCTION
FACILITY
SNAPSHOT
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;
Localization options:
• Primary & Secondary packaging
• Fill & Finish
• Fermentation synthesis of
biopharmaceutical products
14FULL-CYCLE
GMP-COMPLIANT
FACILITY
• 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
QUALITY
ASSURANCE
QUALITY CONTROL
PHARMACEUTICAL
QUALITY SYSTEM
15SCHEDULE OF
INSTALLMENTS
Facilities installment is synchronized with schedule of portfolio
registration, sales growth and state requirements to localization
.
Stage 3: Full cycle of
Stage 1: Set up of production Stage 2:
Stage 0: biologicals
Full cycle of
Construction Phase 1 Phase 2
Solid forms – full cycle Fill finish bilologicals solid forms Phase 1 Phase 2
July 2012 – Dec. 2013 - Feb. 2014 - 2016 - 2018 - 2020 -
Dec. 2013 Dec. 2014 June 2015 2017 2020 2022
Full cycle production Full cycle production –
line №1 line №2 and №3
Solid Granulation Granulation
dosage Tabletizing and Tabletizing and
Site Preparation :
forms capsule filling capsule filling
Purchase of ground Labelling, pre- Labelling, pre-
plot and its formation packing, packaging packing, packaging
Engineering site
preparation, incl Full cycle of solid
internal and external forms:
networks (canalization, Granulation
Secondary packaging of Full cycle of injection
Cytotoxic energy) Tabletizing and
solid and injection forms dosage forms
capsule filling
Construction of Labelling, pre-
production workshops packing, packaging
Construction of none-
production workshops Fill finish
Spray freeze drying Full cycle – Full cycle –
Construction and start Filling in flasks line № 1 line № 2
Biological of energy generating Filling in prefilled
unit syringes
forms
Inspection manufacturing of cell-based vaccines
Labelling, filling, manufacturing of recombinant proteins
packaging protein purification
Soft 16
dosage Outsourced manufacturing
formsCONSTRUCTION:
PHOTO UPDATE
3Q2012 1Q2014
Pension Fund of Russia
3Q2014
17MANUFACTURING
FACILITY FOR SOLID
FORMS
A few days before operations. Licence acquisition -
December 2014; mass production Q2 2015
Stages
Q2 2015 • Granulation
Full cycle production • Tableting and Capsule filling
Line #1 • Labeling, Pre-packing, Packing
Capacity: 500 mln tablets and 100 mln capsules
Q3 2016 • Granulation
Full cycle production • Tableting and Capsule filling
Line #2 & #3 • Labeling, Pre-packing, Packing
Full Capacity: 1 bln tablets and 400 mln capsules
18MANUFACTURING
FACILITY FOR
BIOLOGICALS
Stages
2Q2015 • Filling line, 1 ml syringes, in pharmaceutical isolator
(Fill-Finish) • 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. • 1st production site: manufacturing of cell-based vaccines
API manufacturing) • 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
19CONTENT
Russian market overview
Portfolio Strategy
Manufacturing
Sales & Distribution
Team
Value proposition
20SALES CHANNELS
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.
Development of sales department
Y2014 Y2015 Y2016
Saint-Petersburg
15 employees 20 employees 40 employees
Moscow
Nizhniy Novgorod
12 cities 17 cities 20 cities
Ufa
Rostov
Krasnodar Saratov
Samara
Ekaterinburg
Stavropol
Tumen
Perm
Novosibirsk
Krasnoyarsk
Irkutsk
- Regional manager
- Key account manager
21SALES AND
DISTRIBUTION
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.
NANOLEK’s COMMERCIAL NETWORK
National Distributors
pharmacy
chains National Regional Local
А5 Group F1-A* F2-A F2-B F3-A F3-B
Rigla
Protek Oriola Irvine-2 Pharm-SKD Medservice-
Pharmacy network
Region
36,6 Katren Pulse Godovalov Zdravservice
Implozia Bolear
CIA International Imperia-Pharma Lekrus Vitta Company
Pharmakor
Medical-
SoyuzFarma F1-B PharmComplex Intermedservice Volgopharm
Consulting
Alfega Network
Rosta BSS North-West LipetskFormation
PharmaImpeks F2-С
Rainbow Alliance Healthcare PharmImpeks Baltimor Avikon-Med
Vostok-Pharm
Oriola F1-C Euroservice F2-С Medintorg
Classic Donskoy
Vita Biotek ProfitMed Medexport Hospital
Pharmland Agroresources
Stolichnaya network
Doctor Stoletov
Pharmazevt
Samson-Pharma Nadezhda-Pharm
Opeka
First Aid
Sound of health
Nevis Regional pharmacy chains Delivery to hospitals Delivery to regions
A.V.E. group
22EPIDBIOMED-IMPEX
Well-known and reliable member of Nanolek group
Well-established distribution company for Portfolio Structure
immunobilologicals:
Vaccines 33%
25 mln. USD annual turnover (100% regional
tenders and hospitals)
Fully equipped “cold chain” logistics system Immunoglobulins 14%
Probiotics
Experienced Import and Client Service team Serums 16%
4%
250 + Loyal customers
Albumines 11%
Bacteriophage
Long-terms relationship proved by agreements 8%
with leading manufacturing companies Chemical Formulations 6%
Other 8%
150+ governmental contacts on purchases have
been performed;
Up to 35% of Pandemic Vaccines market;
15% of Local Flu Vaccines market 23CONTENT
Russian market overview
Portfolio Strategy
Manufacturing
Sales & Distribution
Team
Value proposition
24TEAM
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 14 years Vladimir Kutyrov 16 years
General Manager Commercial Director
1997 –founder and Head of «Makiz Pharma». 1998 – 2003 – Regional sales manager at F.Hoffmann-La
2002- «Makiz Pharma» - Russia's first pharmaceutical factory, Roche
designed according to GMP standards. 2003 - 2007 – Regional sales manager at «AstraZeneca».
2007- During 5 years led «Makiz Pharma» to Top 5 Russian 2007 - 2009 – Business Unit Director (Oncology) at OJSC
drugmakers by revenue and sold it to «STADA CIS» for € 125 Verofarm - Russian production company.
million. 2009 - 2014 – Commercial Director at Akrihin.
2007 - Founder and Head the group of companies
«EPIDBIOMED» - a major distributor and immuno-diagnostic
products and medical consumables.
Doctor of Medical
Sciences, Academy of
Natural Sciences
Svetlana Efimova 10 years Andrey Belov 18 years
Head of Production Department
Head of TT/ Procurement Department
1995 - 2007- Electronics Engineer at «Immunopreparat».
2001- 2007- Mechanic at «NPO" Microgen».
2004 - 2005 –Procurement manager at "Vedis-Steel».
2007 - 2011- Deputy of General Manager/ Head of
2005 - 2007 -Procurement Manager at «New Line Fabriк».
production department at «Medical and industrial equipment
2007 - 2010 -Head of procurement department at «Акrihin».
Factory».
2010 - 2014 - Head of procurement department at «R-
2011 – 2013 - Head of solution & lyophilizate production
Pharm».
area (block) at «R-Pharm».
25TEAM
Eugenie Barinov,
Ilya Vyazovsky Vladislav Popov
ACCA
Medical Director Head of Legal Development Financial Director
2004-2007 -Clinical operations 2004-2005 – law consultant in BRIT 2004-2007 - Senior adviser at
manager at «Servier». Company. PricewaterhouseCoopers.
2007-2013 -Clinical operations 2005-2014 - Head of business 2008-2011 - Audit manager at
manager at «Amgen». processes support department in KPMG.
URALSIB Bank; 2011-2013 - Financial director
Russia&CIS at «RATIONAL
14 years 10 years 10 years GmbH»
Alfia Gabidova Alexander Fuchizhi Maria Pavlova
Head of Regulatory Affairs Department Site Chief / Chief Engineer Head of HR department
2001-2013- Senior positions in the 1995-1996 – engineer of production 2003-2006 - HR manager C&B
Ministry of Health of the Russian line «Ferein». department at «Rostelecom».
Federation: 1999-2009 -Head of technical 2006-2010 -Head of recruitment
- Drugs certification State quality development department department at « Actavis».
control; «Bryntsalov- А». 2010-2012 -Head of HR
- Drugs production State quality 2009-2012 – Deputy of technical department at «Actavis» .
20 years control; 18 years 12 years
director «Binenergy».
Pokrovsky Vadim,
Svetlana Gogoleva Svetlana Shabalova
PhD
Head of Quality department Business Development Manager
Head of Portfolio development
2001-2008 гг. – Deputy Head of the 2012 – 2013 гг. – Senior analyst
Quality Control Laboratory «Biofund RVC».
2006-2007 Project manager at «Farmaks».
«Nielsen». 2006 – current time – candidate for
2008-2011 -Head of Quality
2008-2012 гг. – Adviser at «IMS doctor degree in Oncology center
Assurance at «Rosplazma»;
Consulting Group». RONC named N.N.Blokhina.
5 years 2011-2013 гг. – Head of Quality
14 years 14 лет
department at «R-Pharmм».
26CONTENT
Russian market overview
Portfolio Strategy
Manufacturing
Sales & Distribution
Team
Value proposition
27TECHNOLOGY
TRANSFER: CHALLENGE
FOR NANOLEK
What are we looking for?
Collaboration with companies aimed to win on the Russian market
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
28MARKET ACCESS: KEY
COMPETITIVE
ADVANTAGE
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
Strategy and vision
Manufacturing capabilities
Regulatory affairs
Market access
29T H A N K Y O U !
You can also read
