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DEVA HOLDING A'S'

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Title: DEVA HOLDING A'S'


1
DEVA HOLDING A.S.
2
DEVA HOLDING A.S.
  • Group Profile
  • Deva Holding, established in 1958, is one of the
    largest pharmaceutical groups in Turkey with
    activities in pharmaceutical products, API
    manufacturing, and veterinary products
  • Deva Holding is directly engaged in human
    pharmaceuticals business through its production
    facilities and sales organization
  • In addition to the core pharmaceutical business,
    non-core activities include
  • Ampoule manufacturing and cleaning products
    production
  • Marketing sales of cleaning products
  • Catering services insurance brokerage

3
DEVA HOLDING A.S.
  • History
  • 1958 Established by 27 founding shareholders
  • 1960 First manufacturing facility established
  • 1970 Foundation of first API production facility
    in Turkey
  • 1978 Acquisition of Carlo Erba
  • 1991 Foundation of Cerkezköy synthesis plant
  • 1994 Launch of Potassium Clavulanate production
  • 1997 Launch of Cefuroxime Axetil production
  • 2000 Paid in capital was raised to 16 trillion TL
  • 2003 Paid in capital was raised to 48 trillion TL
  • 2004 Amoklavin ranked as best selling drug in
    Turkey

4
DEVA HOLDING A.S.
  • Corporate Structure

5
DEVA HOLDING A.S.
  • Business Lines
  • Human Pharmaceuticals
  • Branded Generics
  • Licensed Product
  • API
  • Veterinary Products
  • Consumer Goods

6
DEVA HOLDING A.S.
  • Breakdown of Consolidated Net Sales 2005

7
HUMAN PHARMACEUTICALS
8
HUMAN PHARMACEUTICALS
  • Market Size
  • Turkish Pharma Market grew at a striking CAGR of
    17.7 between 1999-2005
  • It is expected to reach US 7 billion by the end
    of 2006, based on ex-factory prices
  • Strong growth is likely to continue on the back
    of widening access to healthcare system, rising
    income level and favorable demographics

Turkish Pharmaceutical Market (US million)
1999-2005 CAGR 17.5
Source IMS, Company Estimates
9
HUMAN PHARMACEUTICALS
  • Consumption Per Capita
  • In line with market growth, pharmaceutical
    consumption per capita is increasing as well
  • Consumption per capita reached US 94 in 2005
    (based on IMS Health data) from US 40 in 1999
  • Despite this improvement in recent years, it is
    still far below European countries

Pharmaceutical Consumption Per Capita (2003)
Source EFPIA
10
HUMAN PHARMACEUTICALS
  • Pharmaceutical Consumption Breakdown () - 2004

Source Turkish Pharmaceutical

Manufacturers Association

11
HUMAN PHARMACEUTICALS
  • Competitive Environment 1H06

Top 15 Players - Boxes Sold
Top 15 Players - Revenues
Source IMS
12
HUMAN PHARMACEUTICALS
  • Reference Pricing Mechanism (I)
  • Turkey implemented a reference pricing mechanism
    by the beginning of 2004, replacing the former
    cost-plus system
  • The price ceiling for an original pharmaceutical
    is the lowest ex-factory price found in five
    reference countries France, Greece, Italy,
    Portugal and Spain plus the country of origin
  • If the product is not marketed in any of these
    five countries, any EU country might be taken as
    benchmark
  • Generic product price can be set as high as 80
    of the original product price
  • Price changes in reference countries should be
    communicated to Ministry of Health within three
    months

13
HUMAN PHARMACEUTICALS
  • Exchange Rate Factor
  • EUR / YTL exchange rate is the other key factor
    of pricing in Turkey in addition to reference
    country prices
  • Ministry of Health monitors the exchange rate
    fluctuations on a quarterly basis
  • If the exchange rate fluctuation exceeds 5
    (either way) for 30 days in a row one month
    than Ministry of Health sets the new exchange
    rate level and pharmaceutical prices are adjusted
    accordingly
  • This mechanism provides protection against
    currency risk

14
HUMAN PHARMACEUTICALS
  • Reimbursement Mechanism (I)
  • Three state controlled insurance institutions,
    SSK, Pension Fund and Bag-Kur realigned their
    positive and negative lists
  • Some vitamins, herbals and cosmetics are in the
    Negative List
  • Prescription of certain drugs are limited with
    specialists
  • All other pharmaceuticals are reimbursed, up to a
    certain threshold reimbursement band
  • Reimbursement price ceiling is set as 22 above
    the lowest priced (reference product) in the
    market

15
HUMAN PHARMACEUTICALS
  • Reimbursement Mechanism (II)
  • Reference product should be marketed at least
    five months in the market and should have a
    minimum 1 market share of boxes sold in order to
    be the reference
  • Let it be noted that, original pharmaceuticals
    which exist in the market without generic
    alternatives are not bound with reimbursement
    band. Their full price is reimbursed.

16
HUMAN PHARMACEUTICALS
  • Recent Regulatory Changes
  • Reimbursement price ceiling has been lowered to
    22 on May 1st 2006, from its previous level of
    30
  • 116 products / molecules have been excluded from
    the positive list, such as Gingko Biloba
  • Prescription of some molecules, such as
    Pantoprazole and Atorvastatin, has been limited
    with only a number of specialization areas and /
    or under special conditions
  • Medication period has been limited to 7 days to
    be effective by October 1st. In other words,
    doctors are not allowed to prescribe medication
    for periods longer than 7 days

17
DEVA HUMAN PHARMA
  • Profile
  • Ranks among the top ten players in the overall
    market, Among top 5 in Generics
  • Strong position in the anti-infectives
    (antibiotics) segment with a well established
    portfolio of products and market leading
    positions
  • 75 products in 185 pharmaceutical forms
  • 68 Branded Generic Products, 174 presentation
    forms
  • 7 Licensed Products, 11 presentation forms
  • Strong Sales Force 723 Medical Reps and Sales
    Reps
  • 80 million boxes production capacity

18
DEVA HUMAN PHARMA
  • Therapeutic Breakdown 2005 Pharma Net Sales

19
DEVA HUMAN PHARMA
  • Main Revenue Drivers

20
DEVA HUMAN PHARMA
  • Amoklavin (Potassium Clav.)
  • Amoklavin continues to be the segment leader
  • In 1H06, Amoklavin enjoyed a market share of 23
    in terms of boxes sold
  • Closest competitors Bilim and GSK accounted for
    19 and 17, respectively

1H06 Potassium Clavunate Segment Market Share of
Top 5 Manufacturers ()
Source IMS
21
DEVA HUMAN PHARMA
  • Cefaks (Cefuroxime Axetil)
  • Cefaks posted significant growth in 2005 and
    1H06 became 1 in its segment
  • Segment share of Cefaks climbed to 19 of boxes
    sold for 1H06, from 14 in 2004

1H06 Cefuroxime Axetil Segment Market Share of
Top 5 Manufacturers ()
Source IMS
22
DEVA HUMAN PHARMA
  • Deklarit (Chlarithromycin)
  • Deklarit was 2 of its in 1H06, closely chasing
    the leader
  • It had a market share of 15 of boxes sold

1H06 Chlarithromycin Segment Market Share of Top
5 Manufacturers ()
Source IMS
23
DEVA HUMAN PHARMA
  • Other Key Products
  • Azitro and Dikloron are segment leaders, with
    strong market shares
  • Hitrizin is 2nd in its segment with 26 market
    share
  • Ciflosin is sharing 2nd rank in the segment with
    two other players

Segment Shares of Key Revenue Drivers () 1H06
Source IMS
24
DEVA HUMAN PHARMA
  • New Product Launches in 2006
  • Deva Holding have successfully launched 3 new
    products in 1H06
  • Citrex (Citalopram), anti-depresan
    2005 segment size US 33.8 mn
    2000-2005 CAGR 46.6
  • Devasid (Sulbactam), anti-biotic
    2005 segment size US 110.6 mn
    2000-2005 CAGR 8.7
  • Devalud (Tizanidin), muscle relaxant 2005
    segment size US 5.9 mn 2000-2005
    CAGR 12.9

25
DEVA HUMAN PHARMA
  • New Products
  • Deva lodged license applications for 31 new
    products (molecules) in 105 different
    presentation forms between 2002-2004.
  • 5 of these new products have been licensed and
    successfully launched in 2005
  • Deva has introduced 3 new products in 1H06 and 6
    new products will be launched before the end of
    the year
  • Remaining 17 new molecules will be launched in
    2007 and 2008
  • Total domestic market value of the pipeline (31
    molecules) was US 1,207 million in 2005 IMS
    data

26
DEVA HUMAN PHARMA
  • Pipeline Domestic Market Size (US mn)

1999-2005 CAGR 30
Source IMS
27
DEVA HUMAN PHARMA
  • Competitive Edge
  • Unique and favorable brand equity, being the
    pioneer of many developments in the Turkish
    pharmaceutical industry
  • Strong position in systemic anti-infectives, with
    5 segment leader products
  • Large and aggressive sales organization with
    established contacts to medical doctors,
    pharmacies, hospitals, social security system and
    other major procurement centers
  • Legal and regulatory skills built on 48 years of
    generic drug licensing experience

28
API
29
API
  • Profile
  • One of the first API production in Turkey
  • Currently, two important APIs, Potassium
    Clavulanate and Cefuroxime Axetil, are produced
    within the Group
  • Potassium Clavulanate is the API behind Devas
    top selling drug Amoklavin
  • Cefuroxime Axetil is the API behind Devas second
    best selling drug Cefaks

30
API
  • Potassium Clavulanate
  • Production is located in Izmit Kosekoy Plant
  • One of the six manufacturers worldwide of
    potassium clauvanate, the API in Deva Holdings
    best selling drug Amoklavin
  • The master file of potassium clauvanate is in
    compliance with the regulations of health
    authorities in USA, Canada and Europe
  • Exports to 30 clients in 17 different countries
  • Continuously developing its RD capabilities to
    expand its production line

31
API
  • Cefuroxime Axetil
  • Production is located in Cerkezkoy Fine Chemicals
    Plant
  • In addition to API, finished dosage form of the
    product is also produced within the same facility
  • Cefuroxime Axetil is sold to third parties in
    domestic market and exported as well

32
VETERINARY PRODUCTS
33
VETERINARY PRODUCTS
  • Profile
  • Engaged in the marketing and sale of veterinary
    products
  • Large product portfolio including 60 registered
    products with over 100 presentation forms
  • Markets and sells its products with a total of 32
    personnel working in 5 regions of Turkey and
    distributes them through 30 pharmaceutical
    products wholesalers
  • Second largest player in the market in 2005, with
    a market share of 10 in terms of revenues
  • Veterinary products market size is US 100
    million (2005) and has a stable trend

34
VETERINARY PRODUCTS
  • Veterinary Products Market

35
OUTLOOK AND STRATEGY
36
HUMAN PHARMA
  • Market Trend in January-June
  • Sales volume slowed down in April due to expected
    price adjustments as a result of prospective
    change in reimbursement band
  • Especially generic manufacturers have been
    negatively affected by this slow down
  • In order to protect themselves from a downwards
    price adjustment, pharmacies hesitated to buy in
    large volumes and tried to manage their
    inventories at minimum levels
  • New reimbursement band has been announced in May
    and demand remained weak until mid-June when the
    ambiguity over prices has completely disappeared

37
HUMAN PHARMA
  • Business Outlook (I)
  • Pharmacists are still preferring to operate with
    minimum level of inventories because of three
    main reasons
  • Ambiguity remains over the possible effects of 7
    days medication period limit, that would be
    effective by October 1st, 2006
  • It is still a question mark whether 116 molecules
    that have been excluded from the reimbursement
    list would be substituted by new products
  • Pharmacists are concerned that regulatory changes
    are likely to continue until the end of the year,
    since government aims to remain within the limits
    of the healthcare expenditure budget

38
HUMAN PHARMA
  • Business Outlook (II)
  • However, the demand is expected to surge in
    October and November, since ambiguity over the
    effects of medication limit will disappear once
    it is implemented October 1st
  • Despite these unfavorable conditions in the
    market, there are good news from pricing front
  • Following the mini devaluation in May-June 2006,
    Council of Ministers decided to allow a price
    increase to compensate for the depreciation of
    the local currency
  • Three price increases of 5 have been made in
    July, August and September, and prices have
    recovered in nominal YTL terms to their March
    2006 levels (before the drop of reimbursement
    band)

39
STRATEGY- RESTRUCTURING
  • New Managements Vision
  • Slim and transparent corporate structure
  • Integrated and GMP compliant new manufacturing
    site
  • Fast introduction of new products to domestic
    market
  • Increased level of exports, especially finished
    products
  • Optimized cost and expense structure
  • Enhanced communication with market participants
  • Maximizing value for shareholders

40
STRATEGY
  • Merger of Holding and Subs
  • Deva Holding and its subsidiaries are intended to
    be merged in order to create a slim and
    transparent corporate structure
  • Merger is expected to integrate business lines
    which should ideally have been structured in a
    single entity
  • Post-merger entity is intended to exit from
    non-core businesses such as catering and
    insurance brokerage
  • It is expected that significant cost advantages
    are enjoyed since duplicated departments like
    accounting, finance, HR etc. are intended to be
    eliminated
  • Bottom line New corporate structure is envisaged
    to be easier to understand and easier to value

41
STRATEGY
  • Integration of Production Units
  • Existing production units located in 4 different
    sites will be re-located in an integrated campus
  • Integration is expected to provide improved level
    of communication between production units
    enhanced efficiency and productivity advanced
    and instant management control and supervision
  • Cost cutting consolidated production workforce
    headcount is expected to be lower than current
    figure in existing structure
  • New manufacturing site is expected to get FDA and
    EMEA endorsements, which will provide export
    ability to USA and Western European
    pharmaceutical markets

42
STRATEGY
  • New Markets
  • Expand Export to other countries, as Finished
    Products as well as API
  • Primary target countries are Central Asia,
    Ukraine, Russia
  • After the commissioning of new manufacturing
    facility, Western European countries as well as
    US will be on target.

43
DEVA HOLDING
  • Non-core Asset Divestment Opportunities
  • Existing production units located in 4 different
    sites will be re-located in an integrated campus
  • This consolidation of manufacturing capabilities
    is expected to provide an opportunity to divest
    and / or develop a number of the currently used
    locations
  • According to the evaluation of the management,
    divesting real estate could yield around US 196
    million

44
DEVA HOLDING
  • Real Estate Portfolio (I)

Source Ekol Real Estate Valuation and
Consultancy Co.
45
CONSOLIDATED FINANCIALS
46
DEVA HOLDING - CONSOLIDATED
  • 1H06 Financial Performance
  • Consolidated revenues stood at US 75.1 million
    in 1H06, 16.8 lower compared to US 90.3 mn in
    1H05
  • Main reason behind this drop in sales is the
    weaker than expected human pharma sales during
    April-June period, because of regulatory changes
    that affected market dynamics
  • Gross profitability deteriorated because of the
    loss incurred by API manufacturer subsidiary
    (Depa) and weaker profitability in human pharma
    business
  • Gross margin dropped to 44.7 in 1H06, from 52.3
    in 1H05

47
DEVA HOLDING - CONSOLIDATED
  • 1H06 Financial Performance
  • As a result of drop in sales and decline in gross
    profit, consolidated EBITDA fell to US 6.2
    million in 1H06, from US 21.5 in 1H05
  • Depreciation of YTL during May-June period and
    increases in interest rates up to 400 basis
    points had an adverse effect on financial
    expenses
  • As a result of deteriortion of operational
    profitability and increasing financial expenses,
    Deva posted a negative profit before tax of US
    11.7 million, whereas it recorded a PBT of US
    12.6 mn in the same period of last year

48
DEVA HOLDING - CONSOLIDATED
  • Financial Highlights

49
DEVA HOLDING - CONSOLIDATED
  • Post Balance Sheet Date Events
  • On July 11th, 2006 International Pharma acquired
    18 of Deva Holding shares, from subsidiary
    companies for a price of YTL 8.1 per class C
    share
  • Total cash injection to subsidiaries amounted US
    50 million as a result of the transaction, which
    helped the Group to roll over its short term bank
    loans
  • The Group has used and still using these fund for
    working capital requirements
  • Consequently, consolidated net debt of Deva
    Holding and its subsidiaries dropped by US 50
    million

50
DEVA HOLDING - CONSOLIDATED
  • Financial Outlook
  • Pharma sales is expected to surge beginning with
    September, in line with market trends and
    supported by new marketing and sales strategies
    developed
  • New products will compensate for the retreats
    that some of the established products face as a
    result of increasing competition
  • Financial expenses will decline thanks to
    improved net debt
  • Positive effects of corporate restructuring is
    expected to start to kick in second half of 2007
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