(TRANSLATION FROM THE GERMAN VERSION – FOR CONVENIENCE ONLY / THE SPOKEN WORD IS FINAL)
Chart 1: Annual General Shareholders' Meeting of June 10, 2009
Mr. Chairman,
dear shareholders,
honored guests,
On behalf of the entire Executive Board, I would like to welcome you to
the 2009 Annual General Shareholders' Meeting of STADA Arzneimittel AG.
To begin with, this year, I would like to offer special thanks to Deputy
Chairman of the Supervisory Board and employee representative on the
Supervisory Board, Karl Hertle. After this General Shareholder’s
Meeting, Mr. Hertle will leave the Supervisory Board as, due to age
reasons, he was no longer available for re-election.
Karl Hertle deserves credit for his excellent commitment not only to
social harmony in the company but to STADA as a whole. I would like to
ask you, dear shareholders of this company – particularly also on behalf
of my colleagues on the Executive Board – for a round of respectful
applause for Mr. Hertle and his exemplary constructive exercise of the
rights of co-decision over many years.
The thanks of the Executive Board also go out to employee representative
Mr. Adolf Zissel, who is also leaving the Supervisory Board today.
I would like to congratulate the new or re-elected employee
representatives on the Supervisory Board, Heike Ebert, Karin Schöpper
and Manfred Krüger. On behalf of the Executive Board, I would like to
repeat our promise of constructive cooperation with you.
The thanks of the Executive Board extend also to the entire Supervisory
Board and the Advisory Board for their invariably trustful cooperation
but also in particular to all employees in the Group, whose commitment
and hard work continually contribute to STADA’s success in particularly
difficult times.
Ladies and gentlemen, in fiscal year 2008, STADA achieved operationally
still generally satisfactory business results, even though some of the
expectations held at the beginning of the year could not be met.
When evaluating the fiscal year, the particularly challenging
environment must be taken into account.
For example, in the German domestic market – still the largest national
market for STADA with approximately one third of Group sales – the
statutory health insurance organizations, using the sharpened discount
agreement instruments introduced by the health-care reform, are able to
entice generics suppliers into increasingly intense price and discount
competition – I will go into this in more detail in a moment. This
structural change in the German market meant that despite growth in
sales and particularly market share, the STADA Group had to report
declining generics sales in Germany in 2008.
In several other European countries too, regulatory interventions in
particular relating to price control as well as intensive competition
greatly overshadowed the considerable growth achieved, for example in
Spain, Portugal and the Netherlands.
And finally the current financial and economic crisis has also left its
mark. The operating business of the Group is however quite resilient
with respect to influences of economic trends – health is generally not
the first area where people try to make savings. For example in 2008 and
in the first quarter of 2009, in Russia, a country well-known to have
been particularly badly affected by the economic crisis, we managed to
achieve double-digit percentage growth in sales in local currency.
The financial and economic crisis is however, increasingly affecting
STADA, producing unfavorable currency influences since about the middle
of the fourth quarter of 2008, the important currencies for STADA, the
Russian ruble, Serbian dinar and the pound sterling have recorded a
sudden and massive devaluation against the Group accounting currency of
the euro. Despite operational stability in these countries, this led to
considerable burdens on sales and earnings at the Group level.
Chart 2: Sales
2008: the thirteenth record year in a row
Group sales in 2008, with an increase of 5% to EUR 1.65 billion, reached
a new record level for the 13th year in a row – a satisfactory result in
the view of the Executive Board and also the Supervisory Board,
considering the particularly challenging, regulatory, competitive and
economic environment of financial year 2008.
Even though sales growth of 13% was still achieved after nine months in
2008; sales in the fourth quarter of 2008 were however 14% below sales
in the corresponding quarter of the previous year.
As well as the currency situation I mentioned previously, a very high
base value from the corresponding quarter of the previous year
contributed to this. Because the sale of low-margin non-core activities
in Great Britain generated a decrease of 5 percentage points in the
fourth quarter alone as compared to the previous year as a result of
lost sales.
Additionally, in the fourth quarter of 2008, several one-time special
effects, including a negative patent decision in Germany, had a curbing
effect on sales.
Deducting these special effects and currency influences, the adjusted
decline of Group sales in the fourth quarter of 2008 was no longer at
14% but a moderate 4%.
In the current financial year 2009, the sales situation already
stabilized in the first quarter.
Although for this first quarter, a sales decrease of 6% was reported and
also for the first half of 2009, the Group still expects to report
declining sales. Group sales, however, adjusted for effects from
acquisitions and disposals, sale and discontinuation of business
activities as well as currency effects, grew in the first quarter of
2009 by 4%.
For the full year 2009, based on the expected revival of business in the
second half year, there is still the opportunity to achieve and even
exceed not only the adjusted but even the reported sales level of the
previous year.
Chart 3: Annual
General Shareholders' Meeting of 10 June 2009
The difficult regulatory, competitive and economic business environment
in many national markets was also clearly noticeable in the key earnings
figures of the Group.
In particular, in the German domestic market, STADA was, for the first
time, unable to achieve the Group average operating profitability – a
consequence of the very high level of competition here, which was
triggered by the health care reform from mid 2007.
Because it has opened the door in the German market to the abuse, by way
of discount agreements, of the purchasing power of statutory health
insurance organizations against the generics sector. In these agreements,
the health insurance organizations pressure the generics industry to
reduce their margins, which could take some small market participants on
quite a devastating course and could even do considerable damage to the
big players in the sector.
In any other sector, this mass purchasing power of individual market
participants, in this case the statutory health insurance organizations,
would long ago have attracted the attention of the antitrust authorities
– but this, as we perceive it, buyer trust cannot be legally attacked.
As a result of German health care policy, the health insurance companies
are subject only to a very limited degree to competition law.
At this point, I can only call on German health care policy makers to
swiftly correct the discount agreement instruments after the federal
elections, as otherwise they will systematically drive the production
facilities of the German generics industry out of the country – as,
incidentally, also recently publicly announced by one of our main
competitors. In addition, it will lead to a noticeable deterioration in
patient care within discount agreements.
I find it, for that matter, almost unthinkable that in other countries,
an important and internationally successful industry could be so
systematically damaged by regulatory interventions as continually
happens with the German generics industry, which with STADA, Hexal and
ratiopharm represent or represented three of the TOP 10 generics
companies in the world.
In any case, I am not aware that Teva in Israel, Krka in Slovakia or
Ranbaxy and Dr. Reddy’s in India again and again have been used or are
being used by local politics as preferred targets for cost savings.
Rather the international expansion of the locally grown generic industry
in these countries is regularly strengthened through extensive support
and not continually weakened as in Germany.
To avoid any misunderstandings: Cost containment in the health care
system is necessary. But the question of why, specifically in Germany,
generics suppliers, who by way of their business model already
contribute to cost containment, are continually virtually squeezed out,
while numerous pseudo-innovations generally continue to escape unscathed,
remains a mystery of German health care policy.
I almost fear that in our politicians’ minds, they are still living in
the good old days when the German pharmaceutical research industry was
considered as "the world’s pharmacy” and they have not noticed that the
generics business now makes up the backbone of the German pharmaceutical
supply and also of the German pharmaceutical industry.
In cross-comparison to our internationally active competition, we are
dealing with a serious operative location disadvantage for STADA, the
continuation of which can by the way be found in a tax legislation which
may well question Germany as STADA Group headquarters in the medium
term.
I’m thinking here for example of the so-called interest barrier
introduced by the latest tax legislation, which restricts the tax
deductibility of interest expenses and which added a 5.5 percentage
point burden to STADA’s tax rate in 2008.
But of course, it’s not so easy to just leave our domestic market,
especially when it represents the largest pharmaceutical and also
generics market in Europe at the same time.
For this reason, we have actively taken up the challenge that the German
market currently poses to all generics suppliers and have clearly
directed our strategy towards the target of increased sales and gains in
market share.
This, of course, requires an aggressive price and conditions policy, for
which STADA, thanks to continuous cost optimization, which I will come
to later, is operationally particularly well positioned, also due to,
among other things, considerably lower selling costs in comparison to
competitors as a result of the deliberate elimination of its own doctor
related sales force.
We are convinced that this strategy aimed at gaining market share is the
strategically correct one for every realistic scenario in the German
market at the present time.
Because if the discount agreements remain, size becomes the most
important competitive factor, as only with size is it possible to
withstand the monopoly of the health insurance companies in the medium
term. If, however, discount agreements are removed in the medium term,
the recognition of generics in the market will become more important
again and the market shares achieved will then hopefully be kept with
better margins. STADA is operationally appropriately prepared – as far
as is reasonably possible – for both scenarios.
We are well on the way – the Group's market share in the German generics
market has increased in terms of units sold, quarter by quarter, and
finally in the first quarter of 2009 reached 13.2%. And we have good
reason to expect that this development will also continue in further
quarters.
Because one of our two labels in the German market, STADApharm, since
the beginning of 2009, aims at exactly the growth in units sold we would
like in the current market phase with a revised price strategy,
according to which its products are always to be among the three
cheapest in the market until further notice.
And additionally, we achieved an overall strong result in the AOK
tenders for new discount agreements with our two companies STADApharm
and ALIUD PHARMA, which makes further expansion of our market share in
terms of units sold seem probable.
The two STADA sales companies received, for these Germany-wide AOK
tenders of 63 active ingredients in five regions respectively, that is
of 315 individual lots, a total of 40 awards. These awards, according to
official ex-factory prices at the time of the award in December 2008,
constitute a total of approximately 18% of the annual sales potential
awarded; STADA's previous market share in this part of the portfolio was
below 12%.
For this awarded annual sales potential, the respective SDADA sales
company is the only discount agreement partner of the AOK for the
respective active ingredient in the respective region. Products
prescribed by doctors without discount agreements must be replaced when
dispensed at the pharmacy by the competitive product which is covered by
a discount agreement and contains the same active ingredient if doctors
do not explicitly rule this out in each case by marking it on the
prescription.
After lengthy legal reviews, the agreements have only been in force for
a few days, namely since June 1 of this year.
With the discount agreements gained, the STADA sales companies can now,
in all probability, achieve very significant increases in units sold and
sales, but with considerably reduced margins. However, where the Group
was not awarded any contracts, STADA has to expect, to a large extent, a
decline in demand in prescriptions for AOK-insured persons during the
two-year contract term.
Since the volume gained by STADA exceeds the previous market share of
the Group, the target of further expanding the market position during
the implementation of the new contracts on the market, which is now
beginning, should be reached.
But this should not hide the fact that: We are and we remain opposed to
these discount agreements, even if we have been forced into
participating in their use and we aim as far as is reasonably possible
to be successful with it.
In politics, we will continue to vehemently call for removal of these
agreements, not only with a view to our margins, but particularly also
because of our serious policy objections. And finally, we also find the
product pre-selection caused by discount agreements to be questionable
health care policy, because it means that patient compliance, which is
so important, often falls by the wayside.
Let me summarize my short digression on the German generics market as
follows: In the German generics market, STADA has been and continues to
be operatively able and also strategically prepared to target further
progress in terms of market position and market share by means of an
aggressive price and discount policy. For significant growth in volume
for essential parts of the portfolio we have accepted and will accept
margin reductions in Germany, as long as overall a profitable business
situation is maintained.
The German STADA business will therefore probably continue for some time
to show a below-average operating profitability compared to the Group
average.
And with that, let me come back to STADA’s earnings development.
Ladies and gentlemen, in addition to a difficult regulatory and
competitive environment, STADA’s earnings development in fiscal year
2008 – especially in the fourth quarter – was also burdened by distinct
one-time special effects and non-operational effects from currency
influences and interest rate hedge transactions.
The individual effects are presented in detail in the Annual Report; I
will therefore only go into the three most important now.
Thus, in the German generics market, a surprising decision for STADA by
the Federal Court of Justice (Bundesgerichtshof) of December 17, 2008 in
the patent litigation on the product with the active pharmaceutical
ingredient Olanzapine, which is used for the treatment of mental
illnesses, resulted in significant one-time special effects which
burdened earnings for the Group in the amount of EUR 16 million after
taxes for the reporting year 2008.
In the generics market, as is known, every supplier seeks to have new
product launches take place as soon as possible, as these significantly
determine the long-term market success of generics.
After the Federal Patent Court (Bundespatentgericht), in November 2007
declared the substance patent of the initial supplier for Olanzapine as
null and void, numerous suppliers accordingly immediately introduced
generics with this active ingredient into the German market – thus, also
our two generics labels ALIUD PHARMA und STADApharm.
In December 2008, however, the Federal Court of Justice to our surprise
and that of the entire industry, overrode the decision of the Federal
Patent Court and declared the initial supplier’s patent legally valid
until its normal expiry in 2011.
For generics of all suppliers already on the market, there was therefore
an immediate sales stop.
The related expenses for the STADA Group as well as the provisions to be
made for damage claims from the initial supplier for patent infringement
amounted to the above-mentioned burden on net income in the amount of
EUR 16 million in 2008.
However, with respect to the damages, STADA has since been able to reach
a final settlement with the initial supplier, which is below our
provisions and which therefore led in the first quarter of 2009 to
extraordinary earnings of EUR 3.5 million before taxes.
This patent law development relating to the active ingredient Olanzapine
is an exceptional case as generally in European markets the launch of
generics takes place based not on an invalidity decision but after
regular patent expiry.
But let me say clearly: In the event of situations with the same
available information, i.e. initial invalidity and clearly positive
expectations on the outcome of the patent procedure, we will always take
the same action. As a large generics supplier, STADA cannot spinelessly
stand aside when all other suppliers on the market go ahead and when the
decision of the jurisdiction also indicates with a low risk that this is
possible.
Ladies and gentlemen, a further burdening effect on earnings, which I
would like to briefly explore, originates from the evaluation of
interest rate hedge transactions of a Russian subsidiary in the fourth
quarter of 2008.
At the close of business at the beginning of the fourth quarter of 2008,
we proceeded on the assumption, which was retrospectively proven to be
correct, of an increasing interest rate in Russia, against which, in
view of an existing ruble loan from a previous acquisition financing we
wanted to protect ourselves by carrying out a so-called “swap”, i.e. an
interest rate hedge transaction.
Looking back, the decision to balance the costs of such a hedge by
entering into a so-called “euro-ruble-strike” and not by using a
compensation payment was unfortunately unfavorable. If this had been
done, with a reasonably stable ruble exchange rate, no compensation
payments would have been accrued; not until the ruble sank below a
threshold price would compensation payments, which would admittedly be
higher and uncapped depending on the euro/ruble exchange rate, be
payable at the end of the contract term.
At that time, neither our finance department nor the advisory external
experts expected the possibility of such a rapid and drastic decline in
value of the Russian ruble, as was unfortunately already recorded in the
second half of the fourth quarter.
Without a recovery in the ruble exchange rate – which cannot now be
expected in the current economic crisis – significant compensation
payments will therefore have to be made at the end of the contract term
in 2010, which of course already had to be taken into account in our
balance sheet for December 31, 2008.
Taking into account the ruble-euro forward price for the end of the
business’s contract term – net income in the fourth quarter was thereby
burdened with a net total of EUR 10.1 million.
To be clear: The business decision to enter into the interest rate hedge
transaction was correct, but the decision on which structure to use was
wrong in retrospect – but everything is easier with hindsight.
Because of the drop in the ruble however, the value of the euro in the
existing ruble loan, for which the interest rate hedge transaction was
carried out, is also reduced.
From purely a cash outflow perspective and including later loan
settlement in euro by the Group, this acts as counter trade and thus
leads over time, at least on a Group level, to an almost balanced cash
flow-effect – something which cannot however considerably reduce our or
indeed your anger over the income burden.
After careful consideration, we decided not to terminate the strike and
the associated ongoing currency risk for the moment, which would indeed
be possible by making a significant lump sum payment and thereby further
burdening net income into the millions.
But we would then give up all prospect of extraordinary income and this
prospect is not at all so small, as the ruble forward price in 2010,
which is applied in our books for current business assessment, is
considerably lower than the current ruble-euro exchange rate.
Thus, if the ruble remains relatively stable, then we will be able to
achieve extraordinary income – if the ruble becomes considerably weaker,
then while closely monitoring business, we will have to concern
ourselves with the termination of the strike.
The fact that not every interest rate hedge transaction is always
unfavorable is shown by the third earnings burdening effect in our
income statement, which I would like to look at here in more detail.
In Germany too, we have current interest rate hedge transactions for
existing loans, whose valuation as of the reporting date in accordance
with IFRS resulted in a net burden on Group income of EUR 4.9 million
before taxes in the fourth quarter and of another EUR 3.0 million before
taxes in the first quarter of 2009.
These valuation effects, however, are temporary and purely
accounts-related effects, i.e. valuation effects from an IFRS accounting
treatment with no effect on cash flow, which will automatically be
compensated by exactly the same amount pursuant to these accounting
regulations over the period of business by opposite valuation effects,
i.e. extraordinary income.
With these interest rate hedge transactions we are protecting ourselves
from potential increases in the interest rate level and thus reducing
our interest rate risk, which we believe is appropriate in these times
of high interest rate volatility. We deliberately accept the associated
temporary burden on income, which, as has already been shown, is in the
end nothing more than a postponement of income over time.
Chart 4: Earnings
development 2008 in detail
Ladies and gentlemen, against the backdrop of my remarks on the
operationally challenging environment and the additional burdening
effects it becomes clear that in fiscal year 2008 STADA could not repeat
last year’s record levels in terms of earnings. So in 2008, reported net
income decreased by 27% to EUR 76.2 million.
Pursuant to our longstanding dividend policy, in accordance with which
we distribute approximately 40% of the reported net income, the dividend
proposal of he Executive Board and Supervisory Board also decreases
accordingly, so that we propose to you under item 2 of today’s agenda to
distribute a dividend for fiscal year 2008 of EUR 0.52 per STADA share
and to carry the remaining excess forward.
The decrease in net income, for that matter, leaves its mark on the
Executive Board remuneration as well, the variable component of which
clearly decreased for all members as compared to the previous year – by
an average of approximately 30%.
For evaluating fiscal year 2008, from an operating point of view, the
key earnings figures are to be adjusted for one-time special effects and
non-operational effects from currency influences and interest rate hedge
transactions, the details of which you can find in the Annual Report.
The result is that the accordingly adjusted key earnings figures for
fiscal year 2008 are at the second highest level in STADA’s history.
In 2008, earnings before interest, taxes, depreciation and amortization,
so-called EBITDA, which, from the Executive Board’s perspective is
probably the most appropriate indicator of the operative performance of
a company, reached a figure of EUR 294.3 million and is thus only 7%
below the, for STADA historical record level of the previous year.
In the Executive Board’s and Supervisory Board’s view, STADA thus
achieved a generally still satisfactory operating result in difficult
times in 2008.
And in our outlook on earnings for the current fiscal year 2009 as well,
we of course assume, despite economic conditions that remain challenging,
that the earnings level will continue to be considerable, even if we
fall beneath the figures for the previous year in the first half of
2009.
We have communicated a minimum goal of adjusted EBITDA of EUR 250
million for fiscal year 2009. In view of this target, the adjusted
EBITDA of EUR 67.6 million achieved in the first quarter of 2009 is
already in the upper area of our planning corridor.
With the expected recovery of the business in the second half year, we
therefore definitely deem it possible to reach the earnings level of
2008 again and to even exceed it.
Chart 5: Stable
balance sheet figures
Let us now have a joint at the Group’s financial position together,
which, in the Executive Board’s view, continues to be stable.
As of the balance sheet date 2008, the equity-to-assets ratio amounted
to 34.0%. Thus, it continues to be clearly in a, from the Executive
Board’s perspective, satisfying area of above 30%.
There were clear improvements as compared to the previous year for cash
flow from operating activities in 2008. Operating cash flow adjusted for
significant influences from outside the reporting period reached the
best figure of the company’s history with EUR 151.0 million.
The same applies to free cash flow adjusted analogously with EUR 48.8
million. This clearly positive adjusted free cash flow shows that
STADA’s operating business – without acquisitions – was again financed
through the Group’s self-generated cash flow in 2008.
Net debt amounted to little more than EUR 1 billion at the end of 2008
and is mainly financed via long-term promissory notes from various
international and national banks with maturities in the area of
2010-2015. By the way, in the first quarter of 2009, a slight reduction
of net debt was reached for the third quarter in a row.
The Group’s liquidity was and is guaranteed at all times. Via credit
lines STADA currently has, also for acquisitions, further financial
means in the amount of approximately EUR 500 million at its disposal.
STADA’s stable financial situation is also mirrored by an, as compared
to the previous year, only slightly changed weighted average interest
rate for the Group’s liabilities in the amount of 4.4% in 2008.
From the Executive Board’s perspective, this stability shows that
especially in the current global financial and economic crisis lenders
continue to have a high degree of trust in our Group’s sustainable
economic capacity.
Chart 6:
Irrational share performance
Unfortunately, the capital market, however, has obviously lost this
trust in our sustainable economic capacity, because its reaction to
STADA’s results and outlook was and is disappointing.
Since the second half of 2008, the share price development – also
against the backdrop of the current global financial and economic crisis
– was, as is known, very volatile and strongly decreasing.
Including net debt, today STADA is still only valued at approximately 7
times our adjusted EBITDA from 2008, this figure being markedly low
among all imaginable peers in the generics sector.
What, in our opinion, are the reasons for this? Some things seem to be
rationally explicable, many things, however, appear irrational when
evaluating the reactions of investors to our capital market
communication.
Naturally, the first earnings decrease after 12 years of continuous
growth and the slightly restrained outlook for 2009 results in a loss of
value, but is nearly 80% of share price decrease rationally explicable
with a new sales record and a decrease of adjusted EBITDA of only 7% in
2008?
Naturally, STADA has significant business in Russia, having always
earned, by the way, a lot of praise until halfway through last year. But
is it rational that this regional alignment now obviously burdens our
share price, although we continue to be operatively well on our way
there and it is obvious that this alignment can again be a future
strength of STADA once the economic crisis begins to wind down?
And is it rationally explicable that it is repeatedly speculated –
despite our clear statements to the contrary – whether STADA has a
financing problem, although we are largely financed through long-term
loans and have borrowing facilities in the amount of EUR 500 million at
our disposal?
We consider most of the reasons mentioned for the share price
development to be irrational. In the Executive Board's view, the STADA
share has lost value since the last Annual General Shareholders’ Meeting
to an extent that seems unjustified by the current business development,
as can very forcefully be demonstrated with an indexed comparison of the
development of share price, sales and adjusted EBITDA over recent years.
STADA is just not a company in crisis, rather, will again, also in
fiscal year 2009, that means, at the expected height of the global
financial and economic crisis, which is also strongly shaking up STADA
and those markets relevant for the Group, be clearly profitable. And for
the years to come, from today’s perspective of the Executive Board, more
distinct growth opportunities for STADA can again be seen with the
winding down of the global financial and economic crisis.
Where does this operating confidence come from? I would like to answer
that question with the following remarks.
Chart 7: Health
care market = growth market
First of all, we should call to mind: In the future too, the health care
market will most likely be one of the most important and dynamic growth
markets in the world – and that largely regardless of economic trends.
Global population growth, increasing life expectancy in industrialized
nations as well as medical progress are and will remain the major
drivers in this context.
This is proven by a current survey from the beginning of this year,
according to which the average sales growth rate expected by the
companies themselves for 2009 in the health care sector is the clearly
highest of all industries questioned with above 5%.
Chart 8: Generics
market = growth segment
This continually growing demand is also beneficial for the
pharmaceutical market. Because in the context of a health care economics
comparison with other types of treatments, drugs continue to be deemed
particularly efficient.
The industry’s leading market research institute, IMS Health, estimates
the growth potential of the global pharmaceuticals market for the years
to come to be up to approximately 7% per year in terms of sales – and
that in a study just recently updated and taking the economic crisis
into account.
Within the pharmaceuticals market, especially generics thereby continue
to show high structural growth potentials; the annual sales growth rate
of which is estimated to be at up to approximately 11% according to IMS
Health.
Because generics simply allow for a low-cost medical therapy without
quality cutbacks and as such represent an obvious response to the
continued growing cost pressure.
Therefore, further progress in the penetration of generics is expected
for most markets, which, as is known, currently have widely differing
characteristics.
In addition, the continuous expiration of patents or other commercial
property rights consistently ensures a constant automatic expansion of
market potential available for generic competition.
Chart 9: Growth
driver patent expiry
According to current market research data, the sales volume alone for
active ingredients newly available for generics competition from 2009 to
2013 in the largest European pharmaceutical markets in terms of sales,
Germany, the United Kingdom, France and Italy, amounts to over EUR 18
billion.
And in Germany, we have, after three lean years, now years with major
patent expiries ahead of us, the current sales potential of which will
total more than EUR 4 billion by 2013.
Ladies and gentlemen, if growth continues to be on the table in our
markets, what are then the success factors of a generics company to
successfully turn this market growth into its own growth?
The theoretical answers to this question have not changed over the past
years – and especially STADA can also still give them from a position of
strength.
Chart 10: Strong
product development
Those who orient their business model toward generics and thus toward
taking advantage of patent expiries must be able to timely manage a
continuous flow of new products with its development department – and
that’s exactly the case for STADA.
With the launch of 483 products in individual national markets worldwide,
STADA once again proved the strength of its own product development in
reporting year 2008.
The Group’s development activities are comprehensive and aimed at the
long term; our developers are already today working on new generic
products whose potential launch dates are beyond 2015.
Currently the approval horizon for generics with a Group-wide
significance is usually at least three years.
So products which STADA plans to launch in this period have usually
already been entirely developed today and are in the approval process,
so that they can be available in time for patent expiry.
Thanks to our development strength, our local sales companies were able,
for example, to launch generics with the active pharmaceutical
ingredient Pantoprazole in five European countries at the same time as
patent expiry in the current second quarter of 2009.
Pantoprazole is in terms of sales one of the strongest pharmaceutical
active ingredients in the world for the treatment of gastric and
duodenal ulcers. According to our estimates at ex-factory prices, the
sales volume achieved with this active pharmaceutical ingredient by the
initial supplier in the EU was over EUR 1.1 billion in 2008, thereof
above EUR 200 million in Germany.
For the current fiscal year 2009, STADA already expects Group-wide sales
with Pantoprazole generics in the amount of clear double-digit euro
millions – by the way, this is one of the reasons why we expect a
revival of our business for the second half of 2009.
It is just very important in the generics business to be on the market
as early as possible – and with the launch of Pantoprazole generics in
numerous European countries at the same time as patent expiry, we proved
once again that STADA’s product development meets this essential
market-strategic requirement also on an international level and thus
belongs to the key success factors of the Group.
In the Executive Board’s view, the product pipeline continues to be
well-filled, which, among other things, is visible in the fact that as
of the reporting date December 31, 2008 STADA conducted a total of 1,200
approval procedures for more than 130 active pharmaceutical ingredients
for over 50 countries.
Thus, STADA should also be able to launch numerous new products in the
individual national markets in the future. This applies to generics in
the EU countries in particular. But in addition, the Group will also
conduct further approval activities in markets outside of the EU in
which it has own sales companies or is active in the export business.
In addition to this wide range of successful development projects,
however, STADA’s product development is also seen successes with several
special projects.
Chart 11:
Biosimilars
In fiscal year 2008, the Group’s first biosimilar product with the
active ingredient Epo-zeta was launched. Epo-zeta is used – analogous to
the original biopharmaceutical Erythropoetin – in nephrology for the
treatment of renal anemia with chronic renal insufficiency and in
oncology for the treatment of chemotherapy-induced anemia.
As is known, a biosimilar is a biopharmaceutical product, i.e. a drug
with a protein as a biopharmaceutical active ingredient produced by
genetically modified cell lines which, despite different producing cell
lines, compared to an initial supplier product which is already on the
market, is so similar that the biosimilar has proven therapeutic
equivalence.
The development of biosimilar products is linked with significantly
higher costs and more risks of failure than is the case for classic
generics, so that, as is known, STADA uses a venture capital structure
to finance the project, the BIOCEUTICALS Arzneimittel AG, in which STADA
currently holds 15.86% of the shares and continues to have a so-called
call option on the purchase of all outstanding BIOCEUTICALS shares,
which can be exercised yearly from 2011.
After the successful approval of Epo-zeta for the indications nephrology
and oncology for the EU and for Serbia in the fourth quarter of 2007,
STADA launched Epo-zeta as the Group’s first biosimilar product via the
Group-owned subsidiary cell pharm under the brand name SILAPO®
in Germany and via the Serbian sales company Hemofarm under the brand
name Eqralys® in fiscal year 2008.
Both sales companies hold corresponding semi-exclusive sales licenses
from BIOCEUTICALS for their respective national markets; in the other
EU countries, the US American hospital products company Hospira is the
sales partner of BIOCEUTICALS, as is known.
The market penetration of biosimilars is expected to proceed more slowly
than that of normal generics.
We are right on schedule for our long-communicated goal of EUR 20
million of sales in Germany in the third full marketing year.
While in 2008 only EUR 4.4 million in sales were achieved with SILAPO®,
EUR 3.5 million however in the second quarter, since April this year
monthly sales for this product are already above EUR 1 million. SILAPO®,
too, should be able to help us meet our growth targets for the second
half of 2009 and for the years to come.
For the second biosimilar project Filgrastim, for which cell pharm holds
an exclusive worldwide sales license, first clinical studies, as is
known, have been underway since the second quarter of 2007. Against the
backdrop that first competitors have already received an EU-wide
approval for a Filgrastim biosimilar it will, however, have to be
reviewed in the course of the year in view of these competitors’ market
data which will then be available whether the continuation of the
Filgrastim project by BIOCEUTICALS and the later marketing through cell
pharm remains economically promising.
STADA now has also begun preparatory work for the development of further
biosimilar products from the product category of monoclonal antibodies,
reviewing at the same time various financing models. Because STADA will
not be willing and able to finance these biosimilars, the market
readiness of which would have to be expected for the middle of the
coming decade, via its own cost structure, either.
Chart 12:
Current portfolio expansion: Lemod Solu®, Apo-go®
Another successful special development project comes from our Serbian
development center. Based on the work done there, the Group achieved an
approval of the FDA, i.e. the American approval authority, for the
production and the export to the USA of the product Lemod Solu®
in the fourth quarter of 2008.
Lemod Solu® contains a known and long off-patent active
ingredient from the substance class of corticoids for the emergency
treatment of infectious diseases, namely injectable Methylprednisolone.
The feature of this product is the new application form of a
dual-chamber ampoule which makes for a comfortable, i.e. quicker and
safer application and which, as yet, no other generics supplier
worldwide has in its product portfolio in this form. Against this
backdrop there is the opportunity for the STADA Group to expand export
to the USA by several million euro per year over the next few years.
Another example of a successful special development project finally is
Apo-go®, a product for treatment of otherwise
therapy-resistant forms of Parkinson’s disease with the long-known and
off-patent active ingredient Apomorphin.
In fiscal year 2008, STADA obtained for this branded product, which was
purchased in the context of the acquisition of the British Forum
Bioscience group in 2007, approvals for the first time in six European
countries for the prefilled syringe dosage form.
The international marketing of this branded product which has until now
been primarily sold in the United Kingdom and Ireland thereby gives
important impulses, opening up opportunities for significant additional
sales in the double digit million area with this product in the
following three years.
Chart 13:
International sales structure
As good as a product pipeline may be filled, ladies and gentlemen,
without your own sales infrastructure it is only worth half, as
otherwise you would be dependent on the market success of third parties.
Particularly in Europe, where the individual national markets differ so
widely in their regulations, an important success factor for any
generics supplier is therefore a broad sales presence – and here, too,
STADA continues to put forward a good operative alignment.
Currently, the Group is present in 30 countries with 45 own sales
companies. The focus here continues to be on Europe where STADA
currently operates with 39 sales companies in 25 national markets. In
Asia, we are currently active with our own sales companies in five
selected markets. Additionally, STADA carried out export business in
more than 50 countries without its own local sales company in 2008.
We are therefore represented in terms of sales infrastructure in all the
important EU markets, but also in the most important European non-EU
countries, and are therefore able, particularly here in Europe, to use
the economy of scale effects of an international sales structure for
approval, procurement and production.
We continue to pursue the objective to constantly expand the number and,
if applicable, also the structure of our local sales companies. Thus,
the Group creates an increasingly strong international sales
infrastructure in order to make optimum use of the existing growth
potentials in the individual markets through this on the one hand and to
further reduce dependence from individual national markets on the other
hand.
Because internationalization, which, as is known, we have been
consistently advancing for years and which reduced the German share in
our Group from formerly more than 50% to about one third, is of course
also an important element of our risk diversification.
Chart 14:
Continuing cost optimization
Generics companies pursue a very price-sensitive and thereby also very
cost-sensitive business model – and continuous cost optimization is an
indispensable success factor for everyone in our sector.
In this field, STADA has had proven and continuing instruments for years,
which I already presented to you in past years and which I therefore
would like to only briefly mention today.
As is known, we have pursued a relocation of production capacities from
outsourcing to contract manufacturers – historically and traditionally
very pronounced at STADA – to in-house production particularly at
locations in low-cost countries for several years. And we have achieved
measurable effects with this, as can be recognized from the increasing
share of our in-house production from only 30% in 2005 to 54% in 2008.
Thus, approximately two thirds of the production capacities owned by
STADA are in low-cost countries today, as compared to virtually no
production locations owned by STADA in low-cost countries only five
years ago.
The most recent member of our family of plants is within the framework
of a 50:50 joint venture with a proven local partner the second
pharmaceutical plant in the greater Ho Chi Minh City area, which was
opened in the first quarter of 2008, the first pharmaceuticals plant in
Vietnam with EU certification for marketing of the products manufactured
there.
Also in 2009 and in the years to come, we will continue to consistently
work on the program for production relocation from contract
manufacturers to own plants in low-cost countries and we expect further
significant savings volumes from that.
We also continue to aim, with an increased number of in-house
developments, at achieving a cost reduction for raw material procurement
particularly for strategically important and large products especially
in their initial marketing stage. Because only with such in-house
developments one can avoid long-term supply ties, which are otherwise
almost always connected with the purchase of dossiers or approvals.
Further elements of our continuous cost optimization target the
optimization of procurement, for example with an increasingly global
procurement of our active ingredients and auxiliary materials.
Moreover, growth-related economy of scale effects will also continue to
contribute to cost optimization, and that not only in the field of
procurement and production, but also in sales, because the continuous
expansion of the product portfolio does not at all induce an equally
continuous expansion of the sales infrastructure. In markets
increasingly characterized by tenders, a reduction of sales
infrastructure can also contribute to cost optimization, as we are known
to have already practiced in the German generics market with the
dissolution of our own doctors-related sales force in 2007.
Our cost of marketing and sales ratio has therefore continually
decreased in recent years and we can expect this trend to continue.
The question, of course, arises, how our operating margin will develop
under the offsetting influences from margin pressure and cost
optimization.
Here, we increasingly have to come to a differentiated approach.
Apart from tenders, in which I also include the German discount
agreements, that is in the classic sales-driven Group business, we
continue to target an operating profit margin of at least 15%.
It would be very easy to postulate and meet this margin target
throughout the Group – STADA only had to stay away from tenders. But
that is far away from reality and the market.
Rather, any supplier – including STADA – must ask himself on the
occasion of each single tender, whether the margin target is to be
forced through with the risk of non-consideration or whether, for
specific reasons – for example, the local market strategy – bids are
submitted with lower margins in order to win additional contribution
margins in an absolute perspective.
In other words: In a generics world increasingly driven by tenders,
undifferentiated margin considerations can no longer be used as a
criterion for success. Such a perspective would even strategically
marginalize the companies.
To us, success criteria relevant for generics companies seem to be
market share, adjusted EBITDA and net income and it is in these terms
that we want to measure our success – in good and in difficult times.
Chart 15:
Falling transaction multiples: more opportunities for cautious
acquisition policy
Ladies and gentlemen, let me briefly touch the subject of acquisition
policy. It has always been a part of STADA’s business model to
complement organic growth with added external growth by means of
carefully selected acquisitions.
In the course of 2008 as well as in the current fiscal year 2009 to
date, we have abstained from major acquisitions, buying only, in total
to a very small extent, in the product area, to increase already
existing investments as well as to expand existing businesses in
individual selected national markets.
The reason for that is the decidedly cautious acquisition policy that we
had already begun to pursue early on against the backdrop of the current
global financial and economic crisis.
In reviewing the numerous acquisition opportunities the Executive Board
applied particularly stringent standards in terms of profitability and
appropriateness of the purchase price already in the first half of 2008,
i.e. still before the current global financial and economic crisis fully
erupted.
In 2008, for one transaction in the generics sector an average of more
than 4.5 times the sales and nearly 17 times the EBITDA was paid
according to our data – more than ever before.
And then you will understand and appreciate that at this stage of
overheated markets one simply has to wait until the market has calmed
down, which slowly seems to be the case.
Quite a few objects that we rejected as overpriced one year ago are now
on our desk again with a clearly lower multiple – possibly still
overpriced, but worth a deeper look now. Of course we won’t abandon our
caution – especially in these times we do not want and cannot afford a
mistake with acquisitions.
Chart 16: Item
6: Authorization to acquire and dispose of own shares
Ladies and gentlemen, before I proceed to my closing summary, some brief
comments on item 6 on the agenda.
In recent years, the Annual General Shareholders’ Meeting always adopted
an advance resolution for the acquisition and disposal of own shares. In
2008, too, we did not make use of this advance resolution, because in
the past fiscal year we, exclusively in the context of executing an
employee stock ownership program based on a company agreement in
Germany, purchased 127 of our own shares at an average price of EUR
45.65 and sold 4,819 of our own shares at an average price of EUR 32.90.
Nevertheless, this year once again we would like to have the
authorization to acquire and dispose of own shares extended by a factual
result of approximately one more year, namely until December 10, 2010,
under item 6 of the agenda.
As in the past, this is not the introduction of a share buy-back program,
but an additional strategic option for the Executive Board and
Supervisory Board – and both bodies are of the opinion that in these
times all strategic options should generally be kept open. Without a new
resolution today, this possibility, however, would expire on December 10
of this year.
Chart 17:
STADA’s growth perspectives
Ladies and gentlemen, let me summarize my remarks as follows:
We can assume: The markets on which STADA's business model is focused,
are and remain growth markets.
Of course this – as we described in detail in the risk report of our
latest Annual Report – continues to be inherently linked to a
challenging environment, because long-term growth opportunities attract
intensive competition. In addition, the continuous increase in demand in
the health care and pharmaceutical market leads to constant cost
pressure in many national health care systems, regularly entailing cost
saving state regulation.
And the global financial and economic crisis will possibly bring also
for STADA a number of challenges with it.
But STADA continues to have the known and proven operative strengths:
And with that, it should be possible to cut a significant piece from the
forecast market growth also in the years to come.
Thus, we continue to deem STADA’s operative business model sustainable
and viable for the future and therefore also continue to see, from
today’s perspective, the fundamental chance to achieve again growth in
terms of sales and net income in the years to come regardless of
conditions which remain challenging.
Whether this, also in the environment of the current global financial
and economic crisis, can be achieved in the current fiscal year 2009, is
– as already explained – open. But the possibility is definitely there.
Executive Board, management and all employees will work hard for it and
actively approach the challenges that lay ahead of us.
Ladies and gentlemen, thank you for your attention.
Chart 18: Thank
you very much for your attention!
Chart 19: Annual
General Shareholders’ Meeting June 10, 2009