Title: DEVA HOLDING A'S'
1DEVA HOLDING A.S.
2DEVA 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
3DEVA 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
4DEVA HOLDING A.S.
5DEVA HOLDING A.S.
- Business Lines
- Human Pharmaceuticals
- Branded Generics
- Licensed Product
- API
- Veterinary Products
- Consumer Goods
6DEVA HOLDING A.S.
- Breakdown of Consolidated Net Sales 2005
7HUMAN PHARMACEUTICALS
8HUMAN 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
9HUMAN 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
10HUMAN PHARMACEUTICALS
- Pharmaceutical Consumption Breakdown () - 2004
Source Turkish Pharmaceutical
Manufacturers Association
11HUMAN PHARMACEUTICALS
- Competitive Environment 1H06
Top 15 Players - Boxes Sold
Top 15 Players - Revenues
Source IMS
12HUMAN 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
13HUMAN 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
14HUMAN 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
15HUMAN 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.
16HUMAN 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
17DEVA 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
18DEVA HUMAN PHARMA
- Therapeutic Breakdown 2005 Pharma Net Sales
19DEVA HUMAN PHARMA
20DEVA 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
21DEVA 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
22DEVA 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
23DEVA 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
24DEVA 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
25DEVA 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
26DEVA HUMAN PHARMA
- Pipeline Domestic Market Size (US mn)
1999-2005 CAGR 30
Source IMS
27DEVA 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
28API
29API
- 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
30API
- 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
31API
- 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
32VETERINARY PRODUCTS
33VETERINARY 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
34VETERINARY PRODUCTS
- Veterinary Products Market
35OUTLOOK AND STRATEGY
36HUMAN 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
37HUMAN 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
38HUMAN 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)
39STRATEGY- 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
40STRATEGY
- 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
41STRATEGY
- 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
42STRATEGY
- 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.
43DEVA 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
44DEVA HOLDING
- Real Estate Portfolio (I)
Source Ekol Real Estate Valuation and
Consultancy Co.
45CONSOLIDATED FINANCIALS
46DEVA 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
47DEVA 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
48DEVA HOLDING - CONSOLIDATED
49DEVA 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
50DEVA 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