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PHARMSTANDARD – LEADING RUSSIAN PHARMACEUTICAL COMPANY
Analyst & Investor DaySeptember 13, 2012
Analyst & Investor Day September 13, 2012
Disclaimer and Confidentiality Requirements
This presentation does not constitute or form part of and should not be construed as, an offer to sell or issue or the solicitation of an offer to buy or acquire securities of OJSC Pharmstandard (the “Company”)or any of its subsidiaries in any jurisdiction or an inducement to enter into investment activity. No part of this presentation, nor the fact of its distribution, should form the basis of, or be relied on in connectionwith, any contract or commitment or investment decision whatsoever.
This presentation has been prepared solely for use in connection with the possible offering of ordinary shares (the “Shares”) and global depositary receipts representing shares (“GDRs” and, together with theShares, the “Securities”) in the Company (the “Offering”). This document is an advertisement and not a prospectus and any purchase of Securities in the Offering should be made solely on the basis ofinformation contained in the prospectus and any supplemental prospectus to be published in respect of the Offering. The information contained in this presentation has not been independently verified. Norepresentation, warranty or undertaking, express or implied, is made as to, and no reliance should be placed on, the fairness, accuracy, completeness or correctness of the information or the opinionscontained herein. None of Augment Investments Limited (the “Selling Shareholder”) or the Company or any of their respective affiliates, advisors or representatives shall have any liability whatsoever (innegligence or otherwise) for any loss howsoever arising from any use of this presentation or its contents or otherwise arising in connection with the presentation.
This presentation is only for persons having professional experience in matters relating to investments and must not be acted or relied on by persons who are not Relevant Persons (as defined below).Solicitations resulting from this presentation will only be responded to if the person concerned is a Relevant Person.
This presentation is not for distribution in, nor does it constitute an offer of securities in the United States, Canada, Australia or Japan. Neither the presentation nor any copy of it may be transmitted into theUnited States, its territories or possessions, or distributed, directly or indirectly, in the United States, its territories or possessions. Any failure to comply with this restriction may constitute a violation of USsecurities laws. The presentation is not an offer of securities for sale in the United States. Securities may not be offered or sold in the United States absent registration or an exemption from registration. TheCompany has not registered and does not intend to register any portion of the Offering in the United States or to conduct a public offering of any securities in the United States.
This presentation is made to and directed only at (i) persons outside the United Kingdom, (ii) qualified investors or investment professionals falling within Article 19(5) and Article 49(2) (a) to (d) of the FinancialServices and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”), and (iii) high net worth individuals, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to(d) of the Order (such persons collectively being referred to as "Relevant Persons").
This presentation and its contents are confidential and must not be distributed, published or reproduced (in whole or in part) or disclosed by recipients to any other person, whether or not such person is aRelevant Person. Failure to comply with this restriction may constitute a violation of applicable securities laws. If you have received this presentation and you are not a Relevant Person you must return itimmediately to the Company. This presentation does not constitute a recommendation regarding the securities of the Company.This presentation is not a public offer or advertisement of Securities in the Russian Federation and is not an invitation to make offers to purchase any Securities in the Russian Federation, and must not bepassed on to third parties or otherwise be made publicly available in Russia. The GDRs have not been and will not be registered in Russia and are not intended for “placement” or “circulation” in Russia.This presentation includes 'forward-looking statements'. These statements contain the words "anticipate", "believe", "intend", "estimate", "expect" and words of similar meaning. All statements other thanstatements of historical facts included in this presentation, including, without limitation, those regarding the Company’s financial position, business strategy, plans and objectives of management for futureoperations (including development plans and objectives relating to the Company's projects and services) are forward-looking statements. Such forward-looking statements involve known and unknown risks,uncertainties and other important factors that could cause the actual results, performance or achievements of the Company to be materially different from results, performance or achievements expressed orimplied by such forward-looking statements. Such forward-looking statements are based on numerous assumptions regarding the Company's present and future business strategies and the environment inwhich the Company will operate in the future. These forward-looking statements speak only as at the date of this presentation. Each of the Company and the Selling Shareholder and their respective agents,employees and advisers, expressly disclaims any obligation or undertaking to update any forward-looking statements contained herein.
The information and opinions contained in this document are provided as at the date of this presentation and are subject to change without notice.All information not separately sourced is from Company data.
2
Today’s Presenting Team Pharmstandard OJSC
3
Dr. Igor KrylovCEOChairman of the Management Board Member of the Board of Directors
Elena Arkhangelskaya
CFO
Dr. Alexander Obuhov,
Medical Director
Analyst & Investor Day September 13, 2012
We are dedicated to the development and manufacture of advanced pharmaceutical products, which meet healthcare requirements and
patients’ expectations.
The company is committed to the following guiding principles:
Innovation – speedy implementation of cutting-edge scientific developments in medicine and pharmacology in close cooperation with Russian and international scientists.
Efficiency – implementation of business process management procedures based on an efficient and balanced combination of technical and scientific innovations with a vast practical experience acquired over the years of extensive involvement in pharmaceutical market.
Responsibility – the use of international administrative and technological standards as part of the company’s responsible consumer policy. Compliance with ecological standards and commitment to the reduction of industrial effect on the environment in the context of the company’s responsibility to future generations.
Dr. Olga Mednikova
Chief Sales and Marketing Officer
Kudlay Dmitry,
Biotechnology sales and marketing director
Vassily IvanovBusiness DevelopmentPHD, MBA
Analyst & Investor Day September 13, 2012 4
Pharmstandard at a glance Key events Mission & strategy Pharmaceutical market
Igor KrylovCEO Pharmstandard OJSC
About Pharmstandard (based on 1H2012 results)
• №1 Company among domestic pharmaceutical companies
• №3 Company overall in Russian pharmaceutical market
• 4 pharmaceutical production sites and 1 medical equipment and disposables plant;
• Capacity – more then 1,7 billion packs per year;
• Russian standards compliant facilities & 6 lines on Kursk are EU GMP compliant;
• More than 250 pharmaceutical products;
• More than 5,600 employees
• 765 units in sales force;
• 6 products in Top 20 best selling domestic brands in Russia
Arbidol® №1, Pentalgin® №3, Complivit® №9 Afobazol® №17, Amixin®№18, Flucostat® №19;
• 2 products in Top 20 best selling brands in Russia
Arbidol® №8, Pentalgin® №14;
• Launched 3 new products: Next®, Cyclovita® , Neosmektine® (powder with new taste).
• Revenue amounted to RUR 16,167.0 million;
• Gross profit amounted to RUR 6,228.0 million or 39% of revenue;
• EBIDTA² amounted to RUR 4,125.8 million or 26% of revenue;
• Net profit amounted to RUR 3,074.6 million or 19% of revenue.
²EBIDTA is defined as earnings before interest, taxes, depreciation and amortization and foreign exchange gain (loss).¹Source CMR «Pharmexpert» Center of Marketing Researches (measured by sales)
5Analyst & Investor Day September 13, 2012
Source: Company data, IFRS FS * – excluding TPP products.
Structure of Sales 1H2012
Analyst & Investor Day September 13, 2012
Pharmaceutical products97.6% of 1H 2012 salesRUR 15,786.4 million
OTC68.7% of organic sales
RUR 5,510.9 million
- 17.4% +24.7% +70.0% - 20.4%
TPP
49.2% of pharmaceutical sales
RUR 7,763.6
Rx28.2% of organic sales
RUR 2,259.6 million
Medical Equipment2.4% of 1H 2012 sales
RUR 380.6 million
Organic sales (Company’s own products)
50.8% of pharmaceutical products salesRUR 8,022.8 million
Total Sales in 1H2012 amounted to RUR 16,167.0 mln
6
API1.6% of organic sales
RUR 252.2 million
Analyst & Investor Day September 13, 2012 7
Pharmstandard Strategy:1.Promote our market-leading brands to drive sales growth and profitability• 6 products in Top 20 best selling domestic brands in Russia • 2 products in Top 20 best selling brands in Russia
2. Launch new products on a regular basis• 10 new products will be launched in 2012 3. Expand sales and marketing effort• Marketing, advertising and promotion expenses amounted to RUR 998. 7 million or 50.2% of the total S&D amount, representing
an increase of RUR 339.6 million or 51.5% vs 1H2011 (RUR 659.1 million).
4. Grow through acquisitions and realize synergies• Acquisition of 50.1% stake in BIGPEARL TRADING LIMITED (Cyprus).
Controlling stake in Biomed named after I.I. Mechnikov OJSC , Pharmapark LLC• FAS allowed "Pharmstandard" acquire 100% stake of pharmaceutical company Lecco LLC.5. Cooperation with leading pharmaceutical companies • 5 new collaborations projects with
Chiesi – distribution of 3 products: Atimos®, Clenil®, Foster®. (Therapeutic Areas -Respiratory pathologies)Celgene - distribution of Vidaza®(for the treatment of all FAB subtypes of MDS)Servier – signed contract for the full cycle production of Eurespal® (for the treatment of the upper and lower respiratory tract)Hoffmann-La Roche - received approval for the full cycle production of Mabthera® (treatment of lymphomas).Johnson & Johnson - signed contract for the full cycle production of Incivo® (for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease ) and Intelence® (for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients).
6. Continue to actively control costs7. Exploit opportunities arising from government funding of healthcare
Sales of TPP (under open auctions) will amount roughly RUR 22 billion by the end 2012
Mission we are dedicated to the development and manufacture of advanced pharmaceutical products, which meet healthcare requirements and patients’ expectations.
Pipeline 2012
Analyst & Investor Day September 13, 2012 8
Name of product: Therapeutical segment \ productstatus:
Sales value(RUR mln)
Scheduled date of production
commencementNext®
(coated tablets)
M01A - ANTI-RHEUMATICS, NON-STEROIDAL
OTC
16, 443 Production launched in March 2012
Maxicold® (coated tablets)
R05A - COLD PREPARATIONS WITHOUT ANTI-INFECTIVES
OTC
15,452September 2012
Akorta® (coated tablets)
C10A -hypolipidemic agent \ Rx
5,835 September 2012
Cyclovita® (coated tablets)
Biologically active food supplement \ OTC 0.380 Production launched in July 2012
Neosmektine® (powder with new taste)
A07B – antidiarrheal agent \ OTC 3,654 Production launched in May 2012
Glimepiride(4 tablets)
А10B - hypoglycemic agent \ Rx 6,297November 2012
Octolipen® (600 tablets)
А16A - metabolic agent \Rx
7.550November 2012
Complivit® Ophtalmo for children(poweder suspension)
Biologically active food supplement \ OTC 1.420
March 2013
Codelac®NEO (drops) R05D- central antitussive agent \ OTC 1.154November 2012
Codelac®NEO (syrup) R05D-central antitussive agent \ OTC 1.154November 2012
Bromgeksin syrup (without alcohol) R05C- expectorate mucolytic agent \OTC 14.453 November 2012
What is going to change for Pharmstandard following Russia’s entry into the WTO?
Analyst & Investor Day September 13, 2012 9
• Starting from the third quarter of 2012, the duties levied by Rospatent (the Federal Service on Intellectual Property, Patents & Trademarks of Russia) on Russian pharmaceutical companies have increased and we have effectively been placed on a par with foreign companies.
• The reduction of customs duties for foreign medicines from 15 – 5% to 6.5 – 5% which will take place during a transitional period. Simultaneously, customs duties for medical equipment and medical substances will undergo reduction at a significant rate (up to 2 – 3%).
• The reduction in prices for substances and APIs (active pharmaceutical ingredients) will bring about an insignificant positive effect for Russian pharmaceutical companies.
• We do not see any pre-conditions for an abolition of the 15% price preference for Russian players
• Data Exclusivity. According to the Federal Law No. 271-FZ, dated 11 October 2010, On Introduction of Changes in the Federal Law ‘On the Circulation of Pharmaceutical Products’, paragraph 6 of article 18 is applied to legal relationships established after the day the Protocol about the Russian Federation joining the WTO came into force. If, following the period of six years from the date of registration of an original pharmaceutical product in the territory of the Russian Federation, the term of its patent protection expires, we have no right to refer to the data regarding the pre-clinical and clinical trials of the original product, while preparing documentation on such trials with respect to a generic product. Thismeans that all such trials should be conducted by us fully and independently. Usually, the term of patent protection exceeds six years from the date of registration of the original product and the work on generics starts after the expiration of such term.
Russian pharmaceutical market structure 1H2012vs1H2011
Analyst & Investor Day September 13, 2012 10
Changes 2012VS2011 Value (RUR, bln)
Retail +48.4 (+22%)
Hospital -3.6 (-4.2%)
FRP -2.2(-5.6%)
Market Share – All SegmentsPHST N3
Pharmstandard market position (based on 1H2012 results and excluding sales of TPP )
Source: CMR “ Pharmexpert”
Market Share – Retail SegmentPHST N 3
Pharmstandard keeps stable leading positions on the market11Analyst & Investor Day September 13, 2012
NOVARTIS6.9% (7.5%) SANOFI-
AVENTIS5.5% (5.4%) PHARMSTANDARD
3.5% (3.8%)
TEVAPHARM. LTD.3.4% (3.3%)
BAYERHEALTHCARE
3.1% (2.9%)
ROCHE3.0% (3.2%)
BERLIN-CH/MENARINI
2.8% (2.8%)
MERCK SHARP& DOHME
2.5% (2.1%)
NYCOMED2.5% (2.6%)
GEDEONRICHTER
2.4% (2.5%)
OTHER IMPORT(442 COMP)
38.9%
OTHER LOCATION(535 COMP)
25.4%
NOVARTIS7.3% (7.1%) SANOFI-
AVENTIS5.2% (5.3%) PHARMSTANDARD
4.5% (5.2%)
BAYERHEALTHCARE
3.6% (3.7%)
BERLIN-CH/MENARINI
3.5% (3.6%)
GEDEONRICHTER
3.0% (3.2%)
NYCOMED2.9% (2.9%)
ABBOTTPRODUCTS2.9% (2.7%)
TEVAPHARM. LTD.2.9% (2.7%)
SERVIER2.8% (2.7%)
OTHER IMPORT(385 COMP)
39.0%
OTHER LOCATION(510 COMP)
22.3%
Russian pharmaceutical market VS PHST dynamics (by value)
Analyst & Investor Day September 13, 2012 12
+29%
+27%
+29%
+10%
+13%
4,426.26,198.0
10,061.811,543.4
18,653.516,167.0
1H2007 1H2008 1H2009 1H2010 1H2011 1H2012
+40%
+62.3%
+14.7%
+61.6% -13.3%
Russian pharmaceutical market
Pharmstandard
Source: CMR “ Pharmexpert”. Retail prices and Pharmstandard sales results
NOVARTIS
SANOFI-AVENTIS
PHARMSTANDARD
TEVAPHARM. LTD.
BAYERHEALTHCARE
BERLIN-CH/MENARINI
MERCK SHARP& DOHME
NYCOMED
GEDEONRICHTER
TotalMarket
0%
+5%
+10%
+15%
+20%
+25%
+30%
+35%
50.0% 55.0% 60.0% 65.0% 70.0% 75.0% 80.0% 85.0% 90.0% 95.0%
TOP-10 companies: factors of growth
Analyst & Investor Day September 13, 2012Source: CMR “ Pharmexpert”. Retail prices
Gro
wth
dyn
amic
s,1H
’11
vs. 1
H’1
0
Retail sales share, IH’12
In IH2012 the main growth factor for TOP-10 companies was a budget segment of market
(FRP, Hospital)
*Organic sales (excluding TPP)
13
Third Party Products
Analyst & Investor Day September 13, 2012 14
Brand name: Status: Company name: Type of collaboration: Value of lot, RUR
mln (excluding VAT) Money will be collected in
Mabthera® RX F.Hoffmann-La Roche Tolling and open auctions 1,502 October 2012Prezista® RX Johnson & Johnson Tolling and open auctions 885.3 October 2012Intelence® RX Johnson & Johnson Tolling and open auctions 294.1 October 2012
Coagil® VII RXLLC Generium,
Lekko Open auctions 156.2 September - October 2012
Diaskintest® RXLLC Generium,
Lekko Open auctions 83.6 September 2012
Pulmozyme® RX Hoffmann-La Roche Open auctions 15.5 October 2012
Others TPP:Tolling\open
auctions\distribution\promotion 24.8 October 2012
Total: 2,961.5 October 2012
RX and OTC
1H2012 TPP sales results amounted to RUR 7,763.6 millionPharmstandard won open auctions for supplying pharmaceutical products in the second half of 2012.
Brand name: Status: Company name: Specification: Value of lot, RUR
mln (excluding VAT) Money will be collected in
Phosphoglive® RXOJSC Pharmstandard-
LeksredstvaManufacturing,
promotion,distribution, open auctions14.5 October 2012
Biosulin®H и P RXOJSC Pharmstandard-
UfaVITAManufacturing,
promotion,distribution, open auctions25.4 October 2012
Rastan® RXOJSC Pharmstandard-
UfaVITAManufacturing,
promotion,distribution, open auctions8 October 2012
Total: 47.9 October 2012
Pharmstandard won open auctions for supplying own pharmaceutical products in the second half of 2012.
Third Party Products
Analyst & Investor Day September 13, 2012 15
Brand name: Status: Company name: Type of collaboration: Value of lot, RUR mln (including VAT)
Money will be collected in
Mabthera® RX F.Hoffmann-La Roche Tolling and open auctions 6,792.0in line with the contract
options in case of we will win this lot
Coagil® VII RXLLC Generium,
Lekko Open auctions 1,306.0in line with the contract
options in case of we will win this lot
Velcade® RX Johnson & Johnson Open auctions 5,737.0in line with the contract
options in case of we will win this lot
Pulmozyme® RX Hoffmann-La Roche Open auctions 1,000.0in line with the contract
options in case of we will win this lot
Others TPP:Tolling\open
auctions\distribution\promotion 0.7
in line with the contract options in case of we will win
this lot Total: 14,835.7
RX and OTC
Open auctions which already were announced and Pharmstandard going to participate, information actual for 29 August 2012.
322.0111.266.745.041.329.928.622.522.420.215.714.312.2
USJapanChina
GermanyFrance
BrazilItaly
SpainCanada
UKRussia
IndiaS.Korea
≈
Market size2011, US$ bln
№ 11
Source: IMS. Whosale prices.
Global trends
Analyst & Investor Day September 13, 2012 16
+3.4%+3.9%+23.5%+4.8%+2.3%+15.6%+4.1%+6.6%+4.4%+4.2%+15.7%+15.4%+9.4%
USJapanChina
GermanyFrance
BrazilItaly
SpainCanada
UKRussia
IndiaS.Korea
≈
CAGR07-11
№ 2
Source: IMS. Whosale prices.
Global trends
Analyst & Investor Day September 13, 2012 17
USJapan
China
Germany
France
Brazil
ItalySpain
CanadaUK
Russia
India
S.Korea
+0%
+5%
+10%
+15%
+20%
+25%
0 100 200 300 400 500 600 700 800 900 1 000 1 100
US$per capita
CAGR07-11
Source: IMS
Global trends
Analyst & Investor Day September 13, 2012 18
Pharmstandard 1H2012 IFSR results
Elena ArkhangelskayaCFOOJSC Pharmstandard
Analyst & Investor Day September 13, 2012 19
1H 2012- 1H 2011Revenue Breakdown, RUR mln
Sales in OTC segment decreased by 17.4%, Rx segment grew by 24.7%
Source: Company data, IFRS FS
Analyst & Investor Day September 13, 2012 20
Gross profit organic 58.5%, total business 38.5%
Source: Company data, IFRS FS
Gross profit
Analyst & Investor Day September 13, 2012 21
General and Administration CostsSelling and Distribution Costs
Pharmstandard SG&A costs 16.3% of Total Sales
Source: Company data, IFRS FS
Competitive Cost Structure
Analyst & Investor Day September 13, 2012 22
Net profit of Total Sales 19.0%, organically 27.4%Effective tax rate in 1h 2012 20.7%
Source: Company data, IFRS FS
Net Profit Dynamic
Analyst & Investor Day September 13, 2012 23
EBITDA
EBITDA organic 37.4%, total business 25.5%)
Source: Company data, IFRS FS
EBITDA
Analyst & Investor Day September 13, 2012 24
EBITDA Decrease Structure
Capital Expenditure (PPE*) mln RURIFRS basis mln RUR
Source: Company data, IFRS FS
Consolidated Balance Sheet and CAPEX
CapEx 2005-2008 totals to 3 127 mln RUR
30 Jun 2012
31 Dec 2011
Non-current assets 13 431 12 261Trade receivables* 12 115 14 247Cash and cash equivalents 4 769 5 383Other assets 12 624 11 725Total assets 42 938 43 617Total equity 32 300 30 294Trade and other payables and accruals 9 616 11 235Long-term borrowings and loans 0 0Short-term borrowings and loans 34 733Other liabilities 989 1 400Total liabilities 10 638 13 323Total equity and liabilities 42 938 43 617
Analyst & Investor Day September 13, 2012 25
Purchase of ordinary shares by its subsidiary
Analyst & Investor Day September 13, 2012 26
The following table provides information about Pharmstandard shares ownership (13.09.2012).
Augment Investments Limited 54.32%(Ordinary shares and GDR) LSE (GDR) 27.56%RTS-MICEX (Ordinary shares) 9.68%Shares hold by OJSC Pharmstandard-Leksredstva 8.44%
Free float - 45,85%Free float treated as treasury shares for IFRS purposes (8,44% hold by OJSC Pharmstandard-Leksredstva) Total shares: 37 792 603 (100%)1 Ordinary share = 4 GDR
The purchase of ordinary shares reflects the confidence of the management in the
fundamental value of OJSC Pharmstandard’s ordinary shares.
In future, the purchased shares may be used by the group of companies
Pharmstandard in merger and acquisition deals in line with the general development
strategy of the group of companies Pharmstandard.
Analyst & Investor Day September 13, 2012 27
Olga Mednikova, Chief Sales & Marketing OfficerPharmstandard OJSC Market Trends & Product Overview
Russian pharmaceutical marketStructure by segments – Retail segment domination
Retail268.271%
FRP50.613%
Hosp59.916%
Rur bln, IH'12
Retail2.3489%
FRP0.052%
Hosp0.239%
Units bln, IH'12
Source: CMR “Pharmexpert”. Retail prices.
Analyst & Investor Day September 13, 2012 28
Retail segment is a main driver of the Russian pharmaceutical market by value and volume
144.2185.5
236.3
304.4336.1
378.7
+29% +27% +29% +10% +13%
IH'07 IH'08 IH'09 IH'10 IH'11 IH'12
Rur bln
Russian pharmaceutical market dynamics (by sales value)
Source: CMR “Pharmexpert”. Retail prices.
Analyst & Investor Day September 13, 2012 29
Russian pharmaceutical market demonstrates sustainable growth
Russian pharmaceutical marketStructure by segments – Retail segment – growth driver
219.8
52.863.5
268.2
50.6 59.9
+22% -4% -6%Retail FRP Hosp
IH'11 IH'12Rur bln
Source: CMR “Pharmexpert”. Retail prices
Analyst & Investor Day September 13, 2012 30
26.2
20.7
13.2 13.011.6 11.5
10.59.5 9.4 9.2
+5% +13% +4%+19% +19% +8% +12%
+33%+8% +10%
NOVARTIS6.9% (7.5%)
SANOFI-AVENTIS
5.5% (5.4%)
PHARMSTANDARD3.5% (3.8%)
TEVAPHARM. LTD.3.4% (3.3%)
BAYERHEALTHCARE
3.1% (2.9%)
ROCHE3.0% (3.2%)
BERLIN-CH/MENARINI2.8% (2.8%)
MERCK SHARP& DOHME
2.5% (2.1%)
NYCOMED2.5% (2.6%)
GEDEONRICHTER
2.4% (2.5%)
I'11 I'12Rur bln
TOP-10 companies growth by value on the total Pharmaceutical market, IH’12 vs. IH’11
Organic sales, excluding third party products *
Source: CMR “Pharmexpert”. Retail prices.
Analyst & Investor Day September 13, 2012 31
26.2
20.7
13.2
10.9
13.011.6 11.5
10.59.5 9.4 9.2
+5% +13% +4% +16% +19% +19% +8% +12%+33%
+8% +10%
NOVARTIS6.9% (7.5% )
SANOFI-AVENTIS
5.5% (5.4% )
PHST3.5% (3.8% )
PHST(excl. Arbidol)
TEVAPHARM. LTD.3.4% (3.3% )
BAYERHEALTHCARE
3.1% (2.9% )
ROCHE3.0% (3.2% )
BERLIN-CH/MENARINI
2.8% (2.8% )
MERCK SHARP& DOHME
2.5% (2.1% )
NYCOMED2.5% (2.6% )
GEDEONRICHTER
2.4% (2.5% )
I'11 I'12Rur bln
**
Source: CMR “Pharmexpert”. Retail prices
Pharmstandardorganic sales
without Arbidol
Pharmstandardtotal organic sales
Product portfolio, excluding Arbidol® demonstratesthe above-market sales growth
Analyst & Investor Day September 13, 2012 32
Source: CMR “Pharmexpert”. Retail prices.
10 49614 030
21 70419 387
23 249
11 228 12 611
3 426
4 886
8 560
7 058
7 082
3 9483 045
+36% +60% -13% +15% +3%2007 2008 2009 2010 2011 I'11 I'12
OTHER PHARMSTANDARD
<< segment growth >>
Rur mlnRur mln ARBIDOL(PHARMSTANDARD)
15%
TERAFLU(NOVARTIS)
11%
KAGOCEL(NIARMEDIC)
8%
ANAFERON(MATERIA MEDICA)
8%
OSCILLOCOCCINUM(BUARON LAB.)
8%ANTIGRIPPIN
(ANTIVIRAL, NATUR PRODUCT)7%
VIFERON(FERON)
6%
COLDREX(GSK)
4%
AMIXIN(PHARMSTANDARD)
4%
FERVEX(BMS)
3%
OTHER 26%
Arbidol® – category leader (by sales value in IH’2012)Anti-cold & flu products
Analyst & Investor Day September 13, 2012 33
Arbidol® – category leader (anti-cold & flu products)Pharmstandard MS 20% (season 2011-2012*)
TERAFLU 10.8% OSCILLOCOCCINUM 8.5% ARBIDOL (PHST) 16.4%COLDREX 4.5% ANAFERON 8.3% KAGOCEL 6.3%ANTIGRIPPIN 4.1% VIFERON 6.0% INGAVIRIN 2.6%FERVEX 3.7% AMIXIN (PHST) 3.5% TAMIFLU 1.0%ANTIGRIPPIN MAX 3.7% GRIPPFERON 3.4% REMANTADIN 0.6%
TOP-5SYMPTOMATIC
TOP-5IMMUNOMODULATING
TOP-5ANTIVIRALS
OTHER (55 TM) 16.5%
Source: CMR “Pharmexpert”. Retail prices.
*season 2011-2012 = sep 2011 – apr 2012
Analyst & Investor Day September 13, 2012 34
0.0
1.0
2.0
3.0
4.0
5.0
6.0
7.0
1.Autu
mn-W
inter
2.Wint
er-S
pring
1.Autu
mn-W
inter
2.Wint
er-S
pring
1.Autu
mn-W
inter
2.Wint
er-S
pring
1.Autu
mn-W
inter
2.Wint
er-S
pring
1.Autu
mn-W
inter
2.Wint
er-S
pring
season 07-08 season 08-09 season 09-10 season 10-11 season 11-12
Symptomatic Immunomodulating Antivirals
12.2Rur bln
Sales dynamic of anti- cold & flu products by seasons
Source: CMR “Pharmexpert”. Retail prices.
• Peak sales growth occurs during a pandemic of A-H1N1 in 2009-2010
• Antivirals shows the maximum increase in sales among other
Analyst & Investor Day September 13, 2012 35
19.918.5
36.735.5
22.8
0.0
5.0
10.0
15.0
20.0
25.0
30.0
35.0
40.0
season 07-08 season 08-09 season 09-10 season 10-11 season 11-12
ARBIDOLTERAFLUANAFERONANTIGRIPPINCOLDREXKAGOCELRINZAOSCILOCOCCINUMVIFERONFERVEXCOLDACTANTIGRIPPIN MAXGRIPPFERONRINICOLDCYCLOFERONRINZASIPREMANTADINIMMUNALDIBAZOLECHINACEAOTHER (60 TM)
Packs mln
Arbidol sales is converted into the packs №10(in 3Q'10 Arbidol №40 was launched)
Arbidol® showed the maximum increase in sales among other (season of 2009-2010)
Analyst & Investor Day September 13, 2012 36
69% 69%75%
62%
70%67% 66% 67% 67% 69%
42%45%
49%
40% 40%45%
40% 39% 37% 38%
19%23% 23% 21% 21%
26%
18% 19%15%
18%
1Q'10 2Q'10 3Q'10 4Q'10 1Q'11 2Q'11 3Q'11 4Q'11 1Q'11 2Q'12
Awereness Usage Loyalty
Arbidol® retains level of marketing consumer indicators
Source: TNS Gallup. All 25-45
Analyst & Investor Day September 13, 2012 37
Arbidol® strong benefits
In spite to the fact, that competitors brands are using “market, created and developed by Arbidol” as a source of business –
Arbidol is still gaining the leading positions in terms of:
- unique clinical profile (wide antiviral activity and indications)- safety profile - evidence-based clinical data (number of patients in clinical trials > 14 000)
Analyst & Investor Day September 13, 2012 38
• 5-6 July 2012 in Annesi (France) WHO experts held a conference on effective therapy of flu and other acute respiratory infections
• Arbidol® report was presented by expert from Russia in the section “Expansion of possibilities to treat virus respiratory infections”
• The report covered data from research results on pre-clinical and clinical studies of Arbidol, its action method and safety
• Discussion of the report stressed the importance and quality of existing data from experimental studies on Arbidol, its action method and therapeutic spectrum, resistance potential and significant amount of acquired clinical data on therapeutic and preventive efficiency of the drug
• Attention of WHO experts was drawn to the beginning of multicentral postmarketing clinical study ARBITR, which is performed in accordance with the Russian regulatory requirements
• Postmarketing clinical study ARBITR on Arbidol becames the first Russian clinical study added to the international database ClinicalTrials.gov
Arbidol® data was presented to WHO experts
Analyst & Investor Day September 13, 2012 39
Key Strategic Points for Arbidol®– is to maintain leadership on the anti-cold & flu market
New communication and media-mix 2012
•The unique antiviral medicine combining 3 advantages
- Wide spectrum of antiviral activity (flu and other viral respiratory diseases)- Strengthens the immune system - Effective treatment and prophylaxis
•Enhanced media mix IIH’2012:
- National TV campaign – started in mid August- Radio campaign- Print campaign- Digital campaign- In-door (Moscow Underground)
Analyst & Investor Day September 13, 2012 40
Key Strategic Points 2012: retail activity & medical detailing
• Increased promotional activities in retail segment
• Increasing of coverage and frequency for medical audiences dedicated to Arbidol:
5 additional Field Force units were involved in Arbidol promotion since 1 August 2012
Analyst & Investor Day September 13, 2012 41
Pentalgin® – category leaderNon-narcotic analgesics and antipyretics
5 3956 455
8 86810 536 11 204
5 542 5 132
1 913
2 567
3 366
3 6343 970
1 885 2 320
+23% +36% +16% +7% +0%2007 2008 2009 2010 2011 I'11 I'12
OTHER PHARMSTANDARD
<< segment growth >>
Rur mlnRur mlnPENTALGIN
(PHARMSTANDARD)25%
NUROFEN(RECKITT
BENCKISER)8%
NUROFEN FOR CHILD.(RECKITT
BENCKISER)8%
TEMPALGIN(SOPHARMA)
6%SEDAL-M
(SOPHARMA)4%
BARALGIN(SOTEX)
4%
SOLPADEINE(GSK)
4%
KATADOLON(TEVA PHARM.
IND. LTD.)3%
SEDALGIN(ACTAVIS)
3%
ALKA-SELTZER(BAYER
HEALTHCARE)2%
OTHER33%
Source: CMR “Pharmexpert”. Retail prices
Analyst & Investor Day September 13, 2012 42
Non-narcotic analgesics and antipyretics segment Growth drivers of the segment are codein-free products
Source: CMR “Pharmexpert”. Retail prices.
0
200
400
600
800
1 000
1 200
1 400
1 600
jan 11 feb 11 mar 11 apr 11 may 11 jun 11 jul 11 aug 11 sep 11 oct 11 nov 11 dec 11 jan 12 feb 12 mar 12 apr 12 may 12 jun 12
Without codeine With codeine Total
Rur mln
Analyst & Investor Day September 13, 2012 43
Pentalgin® codeine-free form demonstrates high level of conversion, up to 77% from total brand sales
Source: CMR “Pharmexpert”. Retail prices.
0
50
100
150
200
250
300
350
400
jan 11 feb 11 mar 11 apr 11 may 11 jun 11 jul 11 aug 11 sep 11 oct 11 nov 11 dec 11 jan 12 feb 12 mar 12 apr 12 may 12 jun 12
Pentalgin without codeine Pentalgin with codeine Pentalgin total
Rur mln
77%
23%
Analyst & Investor Day September 13, 2012 44
NUROFEN (RECKITT BENCK.) - 57%
MIG (BERLIN-CH/MENARINI) - 24%
NOVIGAN (DR.REDDY`S) - 07%IBUCLIN (DR.REDDY S) - 05%
NEXT (PHARMSTANDARD) - 03%
0.0
20.0
40.0
60.0
80.0
100.0
120.0
140.0
160.0
180.0
200.0
jan 12 feb 12 mar 12 apr 12 may 12 jun 12 jul 12
Rur mln
New product NEXT® has launched in 2012 in line with the company growth strategy in analgesics (INN - ibuprofen)
Total category sales (IH’12) = 1.4 Rur blnNEXT has already achived 3% MS
Source: CMR “Pharmexpert”. Retail prices.
Analyst & Investor Day September 13, 2012 45
Codelac®Expectorants & Antitussives
6 3148 158
10 85212 245
14 659
7 591 8 109
1 644
2 508
2 026
2 087
2 431
1 256 928
+34% +21% +11% +19% +2%2007 2008 2009 2010 2011 I'11 I'12
OTHER PHARMSTANDARD
<< segment growth >>
Rur mlnRur mln LASOLVAN(BOEHRINGER
ING.)13%
ACC(NOVARTIS)
12%
PULMOZYME(ROCHE)
10%
ASCORIL(GLENMARKPHARM. LTD.)
6%
AMBROBENE(TEVA PHARM.
IND. LTD.)6%
SINECOD(NOVARTIS)
5%CODELAC(PHARMSTANDARD)
5%
TERPINCOD(PHARMSTANDARD)
4%
DOKTOR MOM(UNIQUE
PHARM. LAB.)4%
BROMHEXINE(BERLIN-CH/MENARINI)
3%
OTHER32%
Codelac Broncho (3 form.)
(codein free)41%
Codelac Phyto4%
Codelac55%
Source: CMR “Pharmexpert”. Retail prices.
Analyst & Investor Day September 13, 2012 46
Complivit®(exl. Complivit Calcium D3, SUPL)Multivitamins with minerals
3 7924 650
5 495 5 730 6 249
3 1863 775
1 037
1 127
1 455 1 4391 534
805
952
+20% +20% +3% +9% +18%2007 2008 2009 2010 2011 I'11 I'12
OTHER PHARMSTANDARD
<< segment growth >>
Rur mlnRur mln
VITRUM(UNIPHARM INC.)
27%
COMPLIVIT CA D3(PHARMSTANDARD)
18%
SUPRADYN(BAYER
HEALTHCARE)12%
MULTI-TABS(FERROSAN)
12%
ELEVIT(BAYER
HEALTHCARE)9%
PANTOVIGAR(MERZ GMBH)
5%
MERZ SPEZIALDRAGEES
(MERZ GMBH)3%
SELMEVIT(PHARMSTANDARD)
2%
BIO-MAX(VALENTA)
2%
PERFECTIL(VITABIOTICS)
2%
OTHER8%
Source: CMR “Pharmexpert”. Retail prices.
Analyst & Investor Day September 13, 2012 47
Complivit®Brand development by new sub-brands
Analyst & Investor Day September 13, 2012 48
Complivit sales structureBrand development by new sub-brands – now 60%
73% 73%68%
54%48%
42%
27%22%
20%
24%
20%
19%
4%
7%
9%
8%
8%
5%
11%
11%
13%
3%
10%14%
3% 3%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2007 2008 2009 2010 2011 2012
Complivit base(3 form.)
Complivit line ext.(4 form.)
Complivit line ext.2008 (4 form.)
Complivit line ext.2009 (6 form.)
Complivit line ext.2010 (7 form.)
Complivit line ext.2011 (3 form.)
Source: CMR “Pharmexpert”. Retail prices.
Analyst & Investor Day September 13, 2012 49
Complivit ® Calcium D3Calcium products
4 years
10+ years
10+ years
1 2081 424
1 6692 015
2 193
1 126 1 211
28
95
153
220
299
150243
+23% +20% +23% +12% +14%2007 2008 2009 2010 2011 I'11 I'12
OTHER PHARMSTANDARD
<< segment growth >>
Rur mlnRur mln
CALCIUM D3(NYCOMED)
44%
CALCEMIN(BAYER
HEALTHCARE)24%
COMPLIVIT CA D3(PHARMSTANDARD)
17%
CALCIUM GLUCONATE(SISHUI)
4%
CALCIUM GLUCONATE(MOSHIMPHARM)
2%
CALCIUM GLUCONATE(PHARMAK)
2% OTHER3%
10+ years
10+ years
5 years
Source: CMR “Pharmexpert”. Retail prices.
Analyst & Investor Day September 13, 2012 50
Complivit ® Calcium D3 (5 years, 3rd position, 16% market share)Calcium products
4 years
10+ years
10+ years
10+ years
10+ years
4 years
18.5
85.5
127.7
202.2
280.6
140.8
222.21.6%
6.0%7.4%
10.1%12.3% 12.4%
16.1%
2007 2008 2009 2010 2011 I H'2011 I H'2012
Rurmln
Marketshare
+362%
+49%
+58%
+39%
+58%
Source: CMR “Pharmexpert”. Retail prices.
Analyst & Investor Day September 13, 2012 51
Flucostat - category leaderSystemic agents for fungal infections
3 0433 538 3 728
4 2694 751
2 330 2 634
744
901926
1 056
1 036
479603
+17% +5% +14% +9% +15%2007 2008 2009 2010 2011 I'11 I'12
OTHER PHARMSTANDARD
<< segment growth >>
Rur mlnRur mln FLUKOSTAT(PHARMSTANDARD)
21%
DIFLUCAN(PFIZER)
19%
IRUNINE(VEROPHARM ZAO)
8%MYCOSYST(GEDEONRICHTER)
6%
LAMISIL(NOVARTIS)
4%
ORUNGAL(JANSSEN-
CILAG)4%
RUMICOZ(VALENTA)
4%
PIMAFUCIN(ASTELLAS
PHARMA INC)3%
SAPHOCID(STADAARZ. AG)
3%
MYCOMAX(SANOFI-AVENTIS)
3%
OTHER25%
MS in retail segment
Source: CMR “Pharmexpert”. Retail prices.
Analyst & Investor Day September 13, 2012 52
Afobazol® – category leaderTranquillizers, hypnotic/sedatives
5 years
10+ years
4 7435 758
7 0987 870 8 519
4 160 4 746
517
839
1 088
1 2751 472
692900
+25% +24% +12% +9% +16%2007 2008 2009 2010 2011 I'11 I'12
OTHER PHARMSTANDARD
<< segment growth >>
Rur mlnRur mln APHOBAZOLUM(PHARMSTANDARD)
10%
NOVO-PASSIT(TEVA
PHARM. IND. LTD.)8%
VALOCORDIN(KREWEL
MEUSELBACH)8%
PERSEN(NOVARTIS)
7%
DONORMIL(BMS)
7%
PHENAZEPAM(VALENTA)
6%CORVALOL(PHARMASTART)
6%
CORVALOL(PHARMSTANDARD)
4%
VALOSERDIN(MOSCOW
PHARM.FACTORY)
4%
GRANDAXIN(EGIS)
4%
OTHER36%
10+ years
6 years
Afobazol® growth rate is two times higher segment growth (+30% vs. +16%)
Analyst & Investor Day September 13, 2012 53
Source: CMR “Pharmexpert”. Retail prices.
Acipol®Antidiarrhoeal micro-organisms
10+ years10+
years3 637
4 6225 234
6 2067 029
3 3094 296
67
150
288
350
422
202
279
+29% +16% +19% +14% +30%2007 2008 2009 2010 2011 I'11 I'12
OTHER PHARMSTANDARD
<< segment growth >>
Rur mlnRur mln
LINEX(NOVARTIS)
46%
BIFIFORM(FERROSAN)
15%
HYLAK FORTE(TEVA PHARM.
IND. LTD.)13%
ACIPOL(PHARMSTANDARD)
6%
BACTISUBTIL(SOTEX)
6%
BIFIDUMBACTERIN(PARTNER
AO)5%
ENTEROL(BIOCODEX)
2%
OTHER3%
Acipol® has changed position from 5 to 4 (+1)
Acipol® growth rate +38% vs. segment growth +30%
10+ years10+
years
Analyst & Investor Day September 13, 2012 54
Source: CMR “Pharmexpert”. Retail prices.
Phosphogliv (2nd position among Rx products)Hepatic protectors, lipotropics
10+ years
10+ years6 years
OTC
OTC
OTC
Rx
Rx4 876
6 2138 029
10 46611 717
5 7047 057
232
494
599
906
1 004
527
581
+31% +29% +32% +12% +23%2007 2008 2009 2010 2011 I'11 I'12
OTHER PHARMSTANDARD
<< segment growth >>
Rur mlnRur mln
ESSENTIALE(SANOFI-AVENTIS)
39%
HEPTRAL(ABBOTT
PRODUCTS)24%
ESSLIVER(STADAARZ. AG)
8%
PHOSPHOGLIV(PHARMSTANDARD)
8%
CARSIL(SOPHARMA)
7%
REZALUT PRO(BERLIN-CH/MENARINI)
4%
HEPA-MERZ(MERZGMBH)
3%
OTHER2%
Phosphogliv® has changed position from 5 to 4 (+1)
10+ years
10+ years
7 yearsRx
Rx
OTC
OTC
Analyst & Investor Day September 13, 2012 55
Source: CMR “Pharmexpert”. Retail prices.
Magnelis® B6 (3 years, 3rd position, 9% market share) Magnesium products
10+ years
10+ years
2 years
684997
1 4511 738
2 009
9641 163
0
0
19
108
182
85
121
+46% +47% +26% +19% +22%2007 2008 2009 2010 2011 I'11 I'12
OTHER PHARMSTANDARD
<< segment growth >>
Rur mlnRur mln
MAGNE B6(SANOFI-AVENTIS)
76%
MAGNEROT(WORWAG
PHARMA GMBH)12%
MAGNELIS B6(PHARMSTANDARD)
9%
Magnelis B6 growth rate is two times higher segment growth (+42% vs. +22%)
10+ years
10+ years
3 years
Analyst & Investor Day September 13, 2012 56
Source: CMR “Pharmexpert”. Retail prices.
Combilipen® (5 years, 2nd position, 19% market share) Vitamin B1 and combinations
4 years
10+ years10+
years1 221
1 760 1 8482 051
2 254
1 118 1 296
20
68226
425
490
236
317
+47% +13% +19% +11% +19%2007 2008 2009 2010 2011 I'11 I'12
OTHER PHARMSTANDARD
<< segment growth >>
Rur mlnRur mln
MILGAMMA(WORWAG
PHARMA GMBH)56%
COMBILIPEN(PHARMSTANDARD)
19%
NEUROMULTIVIT(LANNACHER
HEIMITTEL GMBH)16%
COCARBOXYLASE(MICROGEN NPO)
2%
COMPLIGAMV(SOTEX)
2%
PENTOVIT(ALTAIVITAMINY)
1%OTHER
2%
Combilipen® growth rate is three times higher segment growth (+58% vs.
+19%)
Compilipen has changed position from 3 to 2 (+1)
10+ years5
years
Source: CMR “Pharmexpert”. Retail prices.
Analyst & Investor Day September 13, 2012 57
INN TERBINAFINE
Termicon®(7 years, 2nd position, 20% market share) Antifungals, Dermatological, Systemic agents for fungal infections
6 years
10+ years
10+ years
422461 447 447 470
223263
18
27 35 6285
38
66
+11% -1% +6% +9% +26%2007 2008 2009 2010 2011 I'11 I'12
OTHER PHARMSTANDARD
<< segment growth >>
Rur mlnRur mln
LAMISIL(NOVARTIS)
33%
TERMIKON(PHARMSTANDARD)
20%
EXIFINE(DR.REDDY`S)
20%
TERBINAFINE(BIOCOM ZAO)
6%
TERBIZIL(GEDEONRICHTER)
5%
TERBINAFINE(KANONPHARMA)
4%
OTHER2%
10+ years
7 years
Termicon®growth rate is about three times higher
segment growth (+73% vs. +26%)
Termicon® has changed position from 3 to 2 (+1)
Analyst & Investor Day September 13, 2012 58
Source: CMR “Pharmexpert”. Retail prices.
INN AZITHROMYCIN
Azitrox®Macrolides and similar types
10+ years
1 5621 997
2 6852 989
3 403
1 6772 015
55
84
124
155
220
110
130
+29% +35% +12% +15% +20%2007 2008 2009 2010 2011 I'11 I'12
OTHER PHARMSTANDARD
<< segment growth >>
Rur mlnRur mln
SUMAMED(TEVA
PHARM.IND. LTD.)
65%
AZITROX(PHARMSTANDARD)
6%
HEMOMYCIN(STADA
ARZ. AG)6%
AZITHROMYCIN(VERTEX)
5%
ZITROLID(VALENTA)
4%
ZI-FACTOR(VEROPHARM
ZAO)3%
OTHER3%
10+ years
Azitrox®has changed position from 4
to 2 (+2)
Analyst & Investor Day September 13, 2012 59
Source: CMR “Pharmexpert”. Retail prices.
Dmitry KudlayBiotechnology marketing & sales directorPharmstandard OJSC
Analyst & Investor Day September 13, 2012 60
Biotechnology
Definition
(In Greek “bios” means life, “techne” is art, skills and “logos” is word, learning)discipline which search of possibility of living organisms usage, its systems or itslife activity products for technology aims solution, as well as geneticallyengineered living organisms creation with needed properties
Biotechnology is one of the fasten developing fields in world economy
Biotechnology development connect with global human problems solution such aslack of food, energy and mineral raw materials resources, healthcare improvementand environmental quality.
Analyst & Investor Day September 13, 2012 61
• «Red»- human health provision, gene state correction, drugs manufactory (proteins, enzymes, antibodies)
• «Green»- creation and development of gene modified plants (modern methods of agriculture)
• «White»- manufactory of biofuel, food, chemical, oil processing industry.
• «Gray»- environmental-oriented activity
• «Blue»- see organisms and resource potential usage
«Color» classification of core biotechnology directions ((Electron.J. Biotechnol.v.7.n.3.Valpara.so.dic., 2004).
Analyst & Investor Day September 13, 2012 62
• Market value is 65-85 billions rubles per year, import drugs is close out
• Significant industry sector lag from leading countries (USA, Europe, China, India)
• Intensive growth need in genetically engineered drugs field
• High investment expenditure in original molecules development, that’s why Biosimilar direction is growth fast
• Attractive segment for API producers (growth in two times till 11% from total volume)
«Red» biotechnology in Russia
Analyst & Investor Day September 13, 2012 63
Government Programs in Biotechnology Field
Pharmaceutical business development strategy “Pharma 2020”Federal program “Investigation and development in priority directions of Russian scientifictechnology complex in 2007-2012 years”
Federal program “Scientific and educational resources of Russian innovations 2007-2012years”
Fund commitment programs for small enterprises development in scientific sphereRegional programs (Tatarstan and Chuvashia)Bio 2020 project during 2011-2020
According Government resolution generate technology platforms list such as “Medicine of future”, “Bio industry and bio resources”, “Bio energetics”.
Analyst & Investor Day September 13, 2012 64
Genetically engineered products in the world
Products Sales volume (Mio $) Start of sales, year
Genetically engineered human insulin 5340 1982 (USA)
Somatotropic human enzyme 1760 1985 (USA)
Interferon α 2700 1986 (USA)
Erythropoietin 8800 1989 (USA)
GCSF 2520 1991 (USA+ЕС)
Blood clotting factor VIII 670 1992 (USA)
Interferon β 2200 1993 (USA)
Glucocerebrosidase 740 1994 (USA)
Follicular stimulating enzyme 1000 1995 (ЕС)
Blood clotting factor VIIα 630 1996 (ЕС)
Recombinant therapeutic proteins with sales volume more then 500 Mio $ per year(Rader R.A. // 5-th ed. 2005, Rockwill, MD: BioPlan Associates, Inc.)
Analyst & Investor Day September 13, 2012
Analyst & Investor Day September 13, 2012
OJSC Pharmstandard biotechnology products portfolio
Genetically engineered insulin
Biosulin -2006 Diabetes mellitus
Recombinant tuberculin Diaskintest -2009 Tuberculosis detection
Growth hormone Rastan - 2007 Growth hormone deficiency
Filgrastim Neupomax - 2008 Neutropenia
Blood clotting factor VII Koagil-VII-2010 Hemophilia
Interferon β1β Infibeta- 2011 Multiple sclerosis
Promising Directions. Clinical Trials.
R-84 ( 2015) Targeting therapy in oncology diseases
Blood clotting factor VIII (Octofactor -2012) Hemophilia
Blood clotting factor IX(Innonafactor - 2013)
Hemophilia
PEG filgrastim -2014 Neutropenia
Alteplasa (tissue plasminogen activator) (2014)
Acute ischemic stroke/ myocardial infarction
Analyst & Investor Day September 13, 2012
Biotechnological business results, RUR mln
68
* Products Altevir, Diaskintest, Infibeta and partly Coagil are distributed under consignment agreements with third parties*Pharmstandard dataAnalyst & Investor Day September 13, 2012
Business forecast of Biotech products up to 2015 (Rub bln)
0.5 0.6 0.7 0.91.1 1.31.0 1.2 0.9 0.9
1.2 1.82.6
0.1 0.20.3
0.5
0.8
0.9
0.0
1.0
2.0
3.0
4.0
5.0
6.0
7.0
2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
RastanBiosulinInnonafaktorDiaskintestOktofaktorKoagilInfibeta
Rur bln
*Pharmstandard dataAnalyst & Investor Day September 13, 2012 69
Pharmstandard endocrine portfolio*
*Pharmstandard dataAnalyst & Investor Day September 13, 2012 70
The Russian market of human insulin*, IU
* Pharmexpert data
Novo Nordisk
Eli Lilly
Pharmstandard
Sanofi-Aventis Medsintez
0
500
1 000
1 500
2 000
2 500
3 000
2007 2008 2009 2010 2011
mln.
IU
Analyst & Investor Day September 13, 2012 71
Insulin Biosulin, Pharmstandard* (mln. RUR, sales and forecast)
*Pharmstandard data
120.5
165.5
222.2
401.4
478.8502.8
527.9554.3
582.0
2007 2008 2009 2010 2011 2012 2013 2014 2015
Biosulin total sales, Rur mln
Analyst & Investor Day September 13, 2012 72
BiomatikPen – multidose reusable pen
• Reusable pen BiomatikPen
• Pen developed by cooperation of JSC "Pharmstandard" Russia and "Ipsomed AG», Switzerland
• Compliance with ISO 11608 -1:2000
Analyst & Investor Day September 13, 2012 73
The Russian market of somatropin. Sales and forecast.
120
846
623
412
223 216 222178 183 170
42%
3%
15%
100% 100% 100% 100% 100% 100% 100%
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Somatropin total sales, Rur mln PHST market share
Source:* www.zakupki.gov.ru
Analyst & Investor Day September 13, 2012 74
Marketing clinical trials
Program of scientific cooperation with FBGU "Endocrinology Research Center" (2011-2015)
1)Clinical and metabolic effects of substitution therapy with Rastan ® adult patients with congenital somatotropic deficiency, reaching a socially acceptable growth.
2)Clinical, growth and metabolic effects of the drug Rastan ® in complex hormonal therapy in patients with Turner's syndrome
Analyst & Investor Day September 13, 2012 75
Inhibitor Hemophilia Market, sales and forecast, rubles (without VAT)
1.5
0.5
1.1
1.31.0 1.2
0.9 1.0
0.4 0.440 465
28 90317 741 13 569 13 153 12 647 12 452
2009 2010 2011 2012 2013 2014 2015
Inhibitor Hemophilia Market, Rur bln (without VAT)
NovoSeven(Novo-Nordisk)
Koagil-VII(Pharmstandard)
Feiba(Baxter)
Price, Rur/1mg
* www.zakupki.gov.ruAnalyst & Investor Day September 13, 2012 76
77
DIASKINTEST®
• Fusion protein ESAT6-CFP10 was produced by Escherichia coli DLT 1270 (substrain DH10B, with lacI gen in chromosome);
• Fusion protein construction are covered by patent;
• 06.02.2012 group of scientists has been awarded the Russian Government for the introduction into clinical practice DIASKINTEST®
Analyst & Investor Day September 13, 2012
78
DIASKINTEST®, sales and forecast, RUR, million.*
63.3133.7 155.6 172.5 197.7 204.2
299.1
598.2
2009 2010 2011 2012 2013 2014
Federal Central Program, Rur mln Mass screening (children 8-18 years), Rur mln
* www.zakupki.gov.ru
Analyst & Investor Day September 13, 2012
2 4111 941
1 297
451 445 391 350
516 561 699 854
53% 56%
64%
71%
2009 2010 2011 2012 2013 2014 2015
OTHER IFNβ-1b, Rur mln INFIBETA, Rur mln INFIBETA, MS
Interferon Beta-1b Market (Multiple Sclerosis), sales and forecast, RUR, million.
* www.zakupki.gov.ru
Analyst & Investor Day September 13, 2012 79
• Wide portfolio
• Well established evidence clinical base
• Strong manufactory capacity exist (inside and outside of Russia)
• Strong Federal reimbursement programs
• Well developed marketing programs for screening and disease detection improvement
• Professional marketing team
Biotechnology Dept. Key Success Factors
Analyst & Investor Day September 13, 2012 80
Ivanov VassilyBusiness Development DirectorOncology Business Unit Pharmstandard OJSC
Analyst & Investor Day September 13, 2012 81
Cancer Statistics*
*- WHO Global Stat. Report
Category Russia Finland USA Japan
Men 60,3 76,2 76,3 79Women 73,1 83 81,4 86,2Cardio 797 216,3 205,4 124,3Cancer 285 134,8 157,3 133,3Traffic accidents
21 7,5 14,4 2,1
Murder 14 2,1 6,2 0,4Suicide 27 18,8 11 24,4
Ave. life Expectancy
Number of Deaths by Causes (per 100,000 ppl)
Analyst & Investor Day September 13, 2012 82
Cancer Statistics* II
RUSSIAN FEDERATION Male Female Both sexesPopulation (+000) 65 382 76 011 141 394 Number of new cancer cases (+000) 206,40 226,80 433,20 Age-standardised rate (W) 247,10 178,90 200,50 Risk of getting cancer before age 75 (%) 26,10 18,30 21,10
Number of cancer deaths (+000) 152,90 132,10 285,00 Age-standardised rate (W) 180,70 91,80 124,40 Risk of dying from cancer before age 75 (%) 19,90 10,00 13,90
5-year prevalent cases, adult population (thousands) 401,10 607,30 1 008,50 Proportion (per 100,000) 733,00 922,10 836,30
Lung Breast Lung Colorectum Colorectum Colorectum
Stomach Corpus uteri Breast Prostate Stomach Stomach Bladder Cervix uteri Prostate
5 most frequent cancers
*- International Agency for Research on Cancer, WHO
Analyst & Investor Day September 13, 2012 83
Estimated incidence, mortality and 5-year prevalence: both sexes
Number (%) ASR (W) Number (%) ASR (W) Number (%) Prop. Lip, oral cavity 10 480 2,4 4,8 5 170 1,8 2,4 21 756 2,2 18 Nasopharynx 587 0,1 0,3 374 0,1 0,2 1 382 0,1 1,1 Other pharynx 3 710 0,9 1,8 3 192 1,1 1,5 7 205 0,7 6 Oesophagus 7 158 1,7 3,2 6 397 2,2 2,8 5 188 0,5 4,3 Stomach 40 615 9,4 17,5 36 045 12,6 15,2 49 671 4,9 41,2 Colorectum 55 719 12,9 23,8 37 911 13,3 15,2 132 048 13,1 109,5 Liver 6 476 1,5 2,8 8 319 2,9 3,6 5 429 0,5 4,5 Gallbladder 3 274 0,8 1,3 3 197 1,1 1,3 2 453 0,2 2 Pancreas 14 092 3,3 6,1 14 808 5,2 6,3 7 208 0,7 6 Larynx 6 723 1,6 3,2 4 556 1,6 2,1 19 211 1,9 15,9 Lung 56 767 13,1 25,5 51 364 18 22,7 58 398 5,8 48,4 Melanoma of skin 7 744 1,8 3,7 3 159 1,1 1,5 27 352 2,7 22,7 Breast 52 469 12,1 43,2 22 946 8,1 17,1 197 345 19,6 299,6 Cervix uteri 13 807 3,2 13,3 7 161 2,5 5,9 46 588 4,6 70,7 Corpus uteri 18 789 4,3 15,1 5 250 1,8 3,6 71 749 7,1 108,9 Ovary 12 761 2,9 11 7 551 2,6 5,8 31 661 3,1 48,1 Prostate 22 129 5,1 26,1 9 452 3,3 10,8 68 144 6,8 124,5 Testis 1 303 0,3 1,7 398 0,1 0,5 5 037 0,5 9,2 Kidney 17 563 4,1 8,4 8 616 3 3,8 49 216 4,9 40,8 Bladder 13 002 3 5,6 6 872 2,4 2,7 38 630 3,8 32 Brain, nervous system 6 578 1,5 3,9 6 277 2,2 3,4 8 795 0,9 7,3 Thyroid 8 984 2,1 4,7 1 952 0,7 0,8 35 183 3,5 29,2 Hodgkin lymphoma 3 118 0,7 2 1 139 0,4 0,6 10 752 1,1 8,9 NHL 7 006 1,6 3,6 3 832 1,3 1,8 17 644 1,7 14,6 Multiple myeloma 2 488 0,6 1,2 1 941 0,7 0,9 5 295 0,5 4,4 Leukaemia 11 028 2,5 5,9 7 274 2,6 3,5 22 063 2,2 18,3 All cancers excl, non-melanoma skin cancer 433 196 100 200,5 284 988 100 124,4 1 008 466 100 836,3
CancerIncidence Mortality 5-year prevalence
Cancer Statistics Russia* III
Analyst & Investor Day September 13, 2012 84
Cancer Statistics IV (men)
0 5 000 10 000 15 000 20 000 25 000 30 000 35 000 40 000 45 000 50 000
Nasopharynx
Multiple myeloma
Gallbladder
Testis
Thyroid
Hodgkin lymphoma
Melanoma of skin
Other pharynx
Brain, nervous system
NHL
Liver
Leukaemia
Oesophagus
Larynx
Pancreas
Lip, oral cavity
Kidney
Bladder
Prostate
Stomach
Colorectum
Lung
Mortality
Incidence
Analyst & Investor Day September 13, 2012 85
Cancer Statistics IV (women)
- 10 000 20 000 30 000 40 000 50 000 60 000
Nasopharynx Larynx
Other pharynx Multiple myeloma
Oesophagus Hodgkin lymphoma
Gallbladder Lip, oral cavity
Bladder Liver
Brain, nervous system NHL
Melanoma of skin Leukaemia Pancreas Thyroid Kidney Lung Ovary
Cervix uteri Stomach
Corpus uteri Colorectum
Breast
Mortality
Incidence
Analyst & Investor Day September 13, 2012 86
Options for Cancer Therapy
RadiotherapySurgeryChemotherapyTargeted therapy (monoclonal antibody)Palliative care
Analyst & Investor Day September 13, 2012 87
Oncology Market Russia*
Market Size in 2011 – 41,8 bln Rub4 year CAGR – 7%
*- DSM Group statisticsAnalyst & Investor Day September 13, 2012 88
Oncology Market Russia – Top 10 Products*
*- DSM Group statisticsAnalyst & Investor Day September 13, 2012 89
Top Three Brands v. Market
Analyst & Investor Day September 13, 2012 90
7 Targets in 2013Value of 7 drugs category – 2.1 billion* RUR
Analyst & Investor Day September 13, 2012 91
Oncology Portfolio Plan 2013-2014
Product Dosage form Source Project stage Year of launchVinorelbine inner Ready for delivery 2012Idarubicin inner Ready for delivery 2012Epirubicin inner In registration process 2013Fluorouracil inner Ready for delivery 2013Mitoxantrone inner In registration process 2013Paclitaxel inner In registration process 2013Doxorubicin inner In registration process 2013Anastrazole outsource In registration process 2014Letrozole outsource In registration process 2014Bicalutamide outsource In registration process 2014Fludarabine outsource In registration process 2014Gosereline caps outsource In registration process 2014
Mabthera solution for infusion Roche In development of
manufacturing transfer 2014
Velcade lyophilizate JC In development of manufacturing transfer 2013
Imatinib tabs Generium In development 2014
R-84solution for infusion Generium Phase I 2015/ 2016
solution for infusion
tabs
Analyst & Investor Day September 13, 2012 92
Cancer Patients Complaints
78% 77%
51%43% 41% 39%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Weakness Anxiety Sleepdisturbance
Nausea Hair loss Pain
Patie
nts,
%
Ashbury, 1998
Analyst & Investor Day September 13, 2012 93
Treatment Priority: Pain or Weakness
41%
5%
34%
94%
0% 20% 40% 60% 80% 100%
Patients
Doctors
Pain
Weakness
Vogelzang et al., 1997Analyst & Investor Day September 13, 2012 94
Weakness Therapy Options
70% cancer patients experience weakness often complimented with the feeling of lonelinessSocial activity is reduced for 40% patients
Available therapy options:1. Hemotransfusion2. EPO therapy
Analyst & Investor Day September 13, 2012 95
EPO Market* – Value in Oncology
789; 68%
82; 7% 245; 21%
46; 4%
EPO Sales – 1.16 bln Rub
EPO-alpha SyringesEPO-alpha vialsEPO-beta SyringesEPO-beta vials
*- Pharmexpert 2012, 10 000 IU/syringes
Analyst & Investor Day September 13, 2012 96
Pharmexpert 2012 ** - Now in syringes
INN Product name Manufacturer Dosage formMarket share, Rub %
Eprex JC Syringes 50%Eralfon Sotex, Russia Syringes 16%Epocrine NIIChB Vials 7%Aeprine Tutor Syringes 2%Recormone Roche Syringes 21%Epoetine‐Vero Veropharm Vials 1%Epostim Pharmstandard Vials** 3%Eritrostim Microgen Vials 0,1%
Epo‐ alpha
Epo‐beta
EPO Marketed Products – 2011*
Analyst & Investor Day September 13, 2012 97
Analyst & Investor Day September 13, 2012
EPO Market Dynamics, % (by value)
98
111; 48%
59; 25%
42; 18%
20; 9%
EPO – 231 000 syringes & vials
EPO-alpha SyringesEPO-alpha VialsEPO-beta SyringesEPO-beta Vials
*- Pharmexpert 2012
EPO Market - volume
Analyst & Investor Day September 13, 2012 99
Critical Success Factors
Growing demandStable and reliable supplyOnco portfolio synergyStable oncology budget: federal and regionalDedicated team of CAMs
Analyst & Investor Day September 13, 2012 100
0 2 4 6 8 10 12 14 16 18 20
Lip, oral cavityNasopharynx
Other pharynxOesophagus
StomachColorectum
LiverGallbladder
PancreasLarynx
LungMelanoma of skin
BreastCervix uteri
Corpus uteriOvary
ProstateTestis
KidneyBladder
Brain, nervous systemThyroid
Hodgkin lymphomaNon-Hodgkin lymphoma
Multiple myelomaLeukaemia
Russia
Finland
Mortality rate, %
Cancer Mortality – Russia v. Finland
Analyst & Investor Day September 13, 2012 101
Alexander Obukhov, MD Head of Medical Department Pharmstandard OJSC
Analyst & Investor Day September 13, 2012
Prospective trends of modern medicine
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• INFECTIOUS DISEASES• DERMATOLOGY• BRONCHIAL ASTHMA• CARDIOVASCULAR DISEASE • PREVENTIVE MEDICINE• NEUROLOGY• ONCOLOGY• TUBERCULOSIS
Analyst & Investor Day September 13, 2012 103
Analyst & Investor Day September 13, 2012 104
Analyst&Investor Day Presentation, 13 September 2012
The hepatitis C virus (HCV) is a small, enveloped, single stranded,
positive-sense RNA virus. It is a member of the hepacivirus
in the family flaviviridae
Hepatitis C (HCV) infection causes acutesymptoms in 15% of cases. Symptomsare generally mild and vague, includinga decreased appetite, fatigue, nausea,muscle and/or joint paints. Acute HCVinfection leads to chronic disease in 62-100% cases
105Analyst & Investor Day September 13, 2012
Hepatitis C statistics
Analyst & Investor Day September 13, 2012
170 000 000 people - 3% of the
world’s population has been infected with HCV
4 000 000 people are being
infected with HCV annually
350 000 people die every year due to
HCV related disease ( cirrhosis liver cancer)
WWW.WHO.ORG
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Hepatitis C global prevalence
Analyst & Investor Day September 13, 2012 107
Hepatitis C ways of transmission
Analyst & Investor Day September 13, 2012
•The rate increased from 65 to 113 cases per 100000 from 2002 to 2009 among patients aged 15 to 24 years old
Intravenous drug use
Mother to baby
• In the USA- 8-10% in 1970-80, 5% in 1990-1993, <1% after 1993 The modern impact into incidence in the USA reduced almost to zero
Transfusion –associated HCV infection
•Data is controversial. Hetero- or homosexual activity with multiple partners is a mode of transmission
Sexual
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Analyst & Investor Day September 13, 2012
recipients of previously unscreened blood, blood products and organs (blood transfusion or solid organ transplant before 1992, coagulation factor concentrates before 1987) patients and employees in hemodialysis centers (nosocomial infections) hemophiliacs injecting drug users sharing contaminated needles and/or injection materials people exposed to unsterile medical or dental equipment •occupational exposure to blood people administrating or receiving acupuncture and/or tattooing with unsterile medical devices health care workers •sexual, household and perinatal transmission are possible infants born to infected mothers
Who is susceptible to the HCV infection
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HCV outcomes
Analyst & Investor Day September 13, 2012 110
Analyst & Investor Day September 13, 2012
Currently there is no vaccination against hepatitis C. One reason being that the virus comes in many forms and constantly mutates leading to “swarms” of closely related viral genomic sequences (referred to as
quasi-species).
HCV genotype global prevalence
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HCV treatment goals
Analyst & Investor Day September 13, 2012 112
What Treatment is Available?
Interferon – Given by shot, usually 3 times a week
Pegylated interferon– Long-acting, taken once a week
Combination therapy– Ribavirin is a pill taken twice daily– Interferon (standard or pegylated) taken with ribavirin
Analyst & Investor Day September 13, 2012 113
Analyst & Investor Day September 13, 2012
Interferon-based therapy
114
Patients eligible for treatment
Analyst & Investor Day September 13, 2012
Elevated serum alanine aminotransferase (ALT) levels who meet the following criteria
Age greater than 18 yearsPositive HCV antibody and serum HCV RNA test resultsCompensated liver disease (eg, no hepatic encephalopathy or ascites)Acceptable hematologic and biochemical indices (hemoglobin at least 13 g/dL for men and 12 g/dL for women; neutrophil count >1500/mm3, serum creatinine < 1.5 mg/dL) Willingness to be treated and to adhere to treatment requirementsNo contraindications for treatment
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Mechanism of action
Analyst & Investor Day September 13, 2012
Interferon alfa
HCV
IFN receptors
JAK
STAT
STAT1
IRF9
ISGF3ISRE
ISG mRNA
Viral RNA
PKRADA OAS
HCV replicative complex
Assembly
HCV virions
Adapted from Hoofnagle J. NEJM 2006
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Analyst & Investor Day September 13, 2012
First national PEG-Interferon alfa-2b
PEGALTEVIR®
• 3 years development• 2 years pre-clinical studies• Start clinical study - August 2012
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Study design
II PHASE III PHASE
RANDOMIZED OPEN LABEL COMPARATIVE RESEARCH OF
EFFICACY AND SAFETY OF PEGALTEVIR AND PEGINTRON
IN PATIENTS WITH HCV AS PART OF ANTIVIRAL THERAPY.(The stage is corresponded to ii-iii
phases of clinical trials)
RANDOMIZED OPEN LABEL COMPARATIVE RESEARCH OF
EFFICACY AND SAFETY OF PEGALTEVIR AND PEGINTRON
IN PATIENTS WITH HCV AS PART OF ANTIVIRAL THERAPY.(The stage is corresponded to ii-iii
phases of clinical trials)
STUDY WILL BE PERFORMED IN TWO STAGES:
1. 2.
Analyst & Investor Day September 13, 2012 118
Thank you for your the attention!
Analyst & Investor Day September 13, 2012
JSC PharmstandardLikhachevsky drive, 5 «B» Moscow region,
Dolgoprudny, Russia, 141700.Tel/Fax: (495) 970-0030/32
Ilya Krylov IR manager [email protected]
www.pharmstd.ru
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