ITEM 3: KEY INFORMATION
Selected Consolidated Financial Data
The selected consolidated financial data as of and for the years
ended December 31, 2001, 2002, 2003, 2004 and 2005 set
forth below are derived from our consolidated financial
statements.
We prepare our consolidated financial statements in accordance
with International Financial Reporting Standards (IFRS). IFRS
differ in certain significant respects from U.S. Generally
Accepted Accounting Principles (U.S. GAAP). For a
description of the significant differences between IFRS and
U.S. GAAP and a reconciliation of net income and
shareholders equity to U.S. GAAP, see Notes 32
and 33 to our consolidated financial statements.
You should read the information below in conjunction with our
consolidated financial statements and the other financial
information that we have included elsewhere in this annual
report. For our consolidated financial statements as of and for
each of the three years ended December 31, 2005, see the
discussion beginning on page F-1.
- 5 -
Selected Consolidated Financial Data as of and for the Five
Years Ended December 31, 2005
The following table presents selected consolidated financial
information as of and for the five years ended December 31,
2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of and for the year ended December 31,(1)
|
|
|
|
|
2001
|
|
|
2002
|
|
|
2003
|
|
|
2004
|
|
|
2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(
in millions, except per share/ADS amounts)
|
|
|
Selected income statement data
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amounts in accordance with IFRS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales
|
|
|
2,308
|
|
|
|
2,609
|
|
|
|
2,735
|
|
|
|
2,963
|
|
|
|
3,272
|
|
|
Gross profit
|
|
|
1,414
|
|
|
|
1,681
|
|
|
|
1,787
|
(2)
|
|
|
1,947
|
(2)
|
|
|
2,184
|
|
|
Research and development expenses
|
|
|
(285
|
)
|
|
|
(369
|
)
|
|
|
(413
|
)(2)
|
|
|
(448
|
)(2)
|
|
|
(465
|
)
|
|
Operating income
|
|
|
520
|
(3)
|
|
|
538
|
|
|
|
558
|
(2)
|
|
|
604
|
(2)
|
|
|
676
|
|
|
Financial income
|
|
|
24
|
|
|
|
(12
|
)
|
|
|
10
|
(2)
|
|
|
7
|
|
|
|
8
|
|
|
Income before taxes
|
|
|
544
|
|
|
|
527
|
|
|
|
568
|
(2)
|
|
|
611
|
(2)
|
|
|
684
|
|
|
Net income
|
|
|
328
|
|
|
|
324
|
|
|
|
333
|
(2)
|
|
|
379
|
(2)
|
|
|
438
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares outstanding during period
(in millions)
|
|
|
137.5
|
|
|
|
136.6
|
|
|
|
136.3
|
|
|
|
135.9
|
|
|
|
135.6
|
|
|
Basic earnings per share/ADS(4)
|
|
|
2.38
|
|
|
|
2.37
|
|
|
|
2.44
|
(2)
|
|
|
2.78
|
(2)
|
|
|
3.23
|
|
|
Diluted earnings per share/ADS(5)
|
|
|
2.37
|
|
|
|
2.36
|
|
|
|
2.44
|
(2)
|
|
|
2.78
|
(2)
|
|
|
3.23
|
|
|
Dividends per share/ADS(6)
|
|
|
0.60
|
(7)
|
|
|
0.75
|
|
|
|
0.83
|
|
|
|
0.95
|
|
|
|
1.10
|
(8)
|
|
Amounts in accordance with U.S. GAAP
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
|
314
|
|
|
|
338
|
|
|
|
337
|
|
|
|
385
|
|
|
|
428
|
|
|
Basic earnings per share/ADS(4)
|
|
|
2.28
|
|
|
|
2.47
|
|
|
|
2.47
|
|
|
|
2.83
|
|
|
|
3.16
|
|
|
Diluted earnings per share/ADS(5)
|
|
|
2.26
|
|
|
|
2.46
|
|
|
|
2.47
|
|
|
|
2.83
|
|
|
|
3.16
|
|
|
Selected balance sheet data
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amounts in accordance with IFRS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property, plant & equipment
|
|
|
579
|
|
|
|
610
|
|
|
|
687
|
|
|
|
763
|
|
|
|
1,048
|
|
|
Cash & cash equivalents and marketable securities
|
|
|
552
|
|
|
|
584
|
|
|
|
580
|
|
|
|
580
|
|
|
|
604
|
|
|
Total assets
|
|
|
2,127
|
|
|
|
2,269
|
|
|
|
2,532
|
(2)
|
|
|
2,706
|
(2)
|
|
|
3,633
|
|
|
Debt
|
|
|
127
|
|
|
|
117
|
|
|
|
96
|
|
|
|
58
|
(2)
|
|
|
389
|
|
|
Total liabilities
|
|
|
426
|
|
|
|
448
|
|
|
|
527
|
|
|
|
471
|
(2)
|
|
|
885
|
|
|
Total provisions
|
|
|
522
|
|
|
|
563
|
|
|
|
553
|
(2)
|
|
|
585
|
(2)
|
|
|
734
|
|
|
Total shareholders equity
|
|
|
1,170
|
|
|
|
1,250
|
|
|
|
1,452
|
(2)
|
|
|
1,650
|
(2)
|
|
|
2,014
|
|
|
Number of shares outstanding at period end (in millions)
|
|
|
137.2
|
|
|
|
136.5
|
|
|
|
136.3
|
|
|
|
135.3
|
|
|
|
135.8
|
|
|
Amounts in accordance with U.S. GAAP
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total shareholders equity
|
|
|
1,159
|
|
|
|
1,261
|
|
|
|
1,470
|
|
|
|
1,683
|
|
|
|
2,048
|
|
|
Selected cash flow statement data
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amounts in accordance with IFRS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash flow provided by operating activities
|
|
|
309
|
|
|
|
442
|
|
|
|
425
|
|
|
|
427
|
|
|
|
645
|
|
|
Net cash flow used in investing activities
|
|
|
(113
|
)
|
|
|
(204
|
)
|
|
|
(298
|
)
|
|
|
(192
|
)
|
|
|
(637
|
)
|
|
Net cash flow used in financing activities
|
|
|
(116
|
)
|
|
|
(154
|
)
|
|
|
(152
|
)
|
|
|
(201
|
)
|
|
|
130
|
|
|
|
|
|
(1)
|
Columns may not add due to rounding.
|
- 6 -
|
|
|
|
(2)
|
2003 and 2004 figures have been adjusted to reflect the
retroactive application of IFRS 2, revised IAS 1, an amendment
to IAS 19 and IAS 39. For further details regarding these
accounting standards see Notes 2 and 32 to our consolidated
financial statements as of and for the year ended
December 31, 2005. No adjustments have been made to our
2001 and 2002 consolidated financial statements.
|
|
|
|
(3)
|
Includes a one-time gain in the amount of
110 million
resulting from the sale of our interest in a joint venture and a
special donation of
15 million to a charitable endowment.
|
|
|
|
(4)
|
Basic earnings per share is computed by dividing net income by
the weighted average number of shares outstanding during the
relevant period. As from December 31, 2003, the weighted
average number of shares includes shares issuable in connection
with the legal proceedings surrounding Deutsch-Atlantische
Telegraphen AG (DAT). See Item 4:
Information on the Company Legal Proceedings
for more information on these proceedings.
|
|
|
|
(5)
|
Diluted earnings per share is computed by dividing net income by
the sum total of the weighted average number of shares
outstanding during the relevant period, adjusted for shares
issuable upon the exercise of options under stock option plans
and, for years ended on or before December 31, 2002, shares
issuable in connection with the DAT litigation.
|
|
|
|
(6)
|
Dividends are presented in the column of the year in respect of
which they are declared. Dividends are paid in the year
following the year in respect of which they are declared.
|
|
|
|
(7)
|
Does not include a one-time bonus dividend in the amount of
0.10 per share.
|
|
|
|
(8)
|
Management proposal to be submitted to our shareholders for
approval at the annual general meeting to be held on May 2,
2006.
|
- 7 -
Dividends
The following table sets forth the dividends per share paid in
respect of each of the five years in the period ended
December 31, 2005 in euro and U.S. dollars. We declare
dividends in euro. For purposes of the table below, we have
converted the amounts paid as dividends into U.S. dollars
using the noon buying rate on the date of the shareholders
meeting at which the relevant dividends were approved. The table
does not reflect the related tax credits that were available to
German taxpayers in respect of dividend payments prior to 2002.
Owners of our shares who are U.S. residents should be aware
that they will be subject to German withholding tax on any
dividends that they receive. See Item 10: Additional
Information Taxation.
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31,
|
|
Dividend per share
|
|
|
|
|
|
|
|
|
|
(
)
|
|
|
($)
|
|
|
2001(1)
|
|
|
0.60
|
|
|
|
0.54
|
|
|
2002
|
|
|
0.75
|
|
|
|
0.85
|
|
|
2003
|
|
|
0.83
|
|
|
|
1.00
|
|
|
2004
|
|
|
0.95
|
|
|
|
1.23
|
|
|
2005
|
|
|
1.10(2
|
)
|
|
|
|
|
|
|
|
|
(1)
|
Does not include a one-time bonus dividend in the amount of
0.10 per share.
|
|
|
|
(2)
|
Management proposal to be submitted to our shareholders for
approval at the annual general meeting to be held on May 2,
2006.
|
Both net income distributable as dividends and net income
subject to German tax are determined on the basis of the
stand-alone unconsolidated financial statements of our holding
company, ALTANA Aktiengesellschaft, prepared in accordance with
German GAAP. German GAAP differ in a number of important
respects from both IFRS and U.S. GAAP. In 2005, our holding
companys net income calculated on an unconsolidated basis
in accordance with German GAAP was
217 million,
compared with
164 million
in 2004 and
276 million in 2003.
Exchange Rate Information
We publish our consolidated financial statements in euro. As
used in this annual report, euro, EUR or
means the single unified currency of the European
Monetary Union. U.S. dollar, USD,
U.S.$ or $ means the lawful currency of
the United States of America. As used in this annual report, the
term noon buying rate refers to the exchange rate
for euro, expressed in U.S. dollars per euro, as announced
by the Federal Reserve Bank of New York for customs purposes as
the rate in the city of New York for cable transfers in foreign
currencies.
To enable you to ascertain how the trends in our financial
results would have appeared had they been expressed in
U.S. dollars, the table below shows the average noon buying
rates for U.S. dollars per euro for the five years ended
December 31, 2005. The averages set forth in the table
below have been computed using the noon buying rate on the last
business day of each month during the periods indicated.
|
|
|
|
|
|
|
Year ended December 31,
|
|
Average
|
|
|
|
|
|
|
|
2001
|
|
|
0.8909
|
|
|
2002
|
|
|
0.9495
|
|
|
2003
|
|
|
1.1411
|
|
|
2004
|
|
|
1.2478
|
|
|
2005
|
|
|
1.2400
|
|
- 8 -
The following table shows the noon buying rates for
U.S. dollars per euro for the six months ended
March 31, 2006:
|
|
|
|
|
|
|
|
|
|
|
Month
|
|
High
|
|
|
Low
|
|
|
|
|
|
|
|
|
|
|
October 2005
|
|
|
1.2148
|
|
|
|
1.1914
|
|
|
November 2005
|
|
|
1.2067
|
|
|
|
1.1667
|
|
|
December 2005
|
|
|
1.2041
|
|
|
|
1.1699
|
|
|
January 2006
|
|
|
1.2287
|
|
|
|
1.1980
|
|
|
February 2006
|
|
|
1.2100
|
|
|
|
1.1860
|
|
On March 20, 2006, the noon buying rate was $1.2168 per
1.00.
Since the beginning of 1999, our shares have traded on the
Frankfurt Stock Exchange in euro. We expect that fluctuations in
the exchange rate between the euro and the U.S. dollar will
affect the U.S. dollar equivalent of the euro price of our
shares on the Frankfurt Stock Exchange and as a result are
likely to affect the market price of our American Depositary
Shares (ADSs) on the New York Stock Exchange. In
addition, you should note that any cash dividends that we may
declare in the future will be denominated in euro. Therefore,
exchange rate fluctuations between the euro and the
U.S. dollar will affect the U.S. dollar amounts that
the holders of our ADSs will receive upon the conversion of any
cash dividends that we may pay out on the shares represented by
these ADSs.
A substantial portion of our assets, liabilities, revenues and
expenses are denominated in currencies other than the euro.
Accordingly, fluctuations in the value of the euro relative to
other currencies have had a significant effect on the
translation into euro of our non-euro assets, liabilities,
revenues and expenses, and may continue to do so in the future.
For further information on the impact of fluctuations in
exchange rates on our operations, see
Risk Factors Risks Related to each
of our Businesses and
Item 11: Quantitative and Qualitative
Disclosures About Market Risk.
Risk Factors
Our business, financial condition and results of operations may
suffer material adverse effects due to any of the following
risks. Additional risks not known to us or that we now consider
immaterial also may adversely affect our business.
Risks Related to each of our Businesses
Because the industries in which we operate are
characterized by constant innovation and technological change,
our success depends upon our continued ability to develop and
market innovative products on a cost-effective basis. If we fail
to do so, we may be unable to capture additional market share or
may lose market share.
We operate in the pharmaceuticals and the specialty chemicals
industries, both of which are highly competitive and are
characterized by intensive research and development efforts and
rapid technological change. Our success is highly dependent on
our ability to discover, develop and manufacture new and
innovative products on a cost-effective basis and to market them
successfully. In doing so, we face and will continue to face
intense competition from a variety of competitors, ranging from
small niche companies to large national and international
conglomerates. Based on total assets and annual revenues, we are
significantly smaller than many of our competitors, which often
have substantially greater financial, R&D and sales and
marketing resources than we do. In addition, we may have fewer
drug candidates in our pipeline than our larger competitors. As
a result, our competitors may succeed in developing and
manufacturing products that are superior to our own products or
that the market perceives to be more attractive. If this
happens, our products may become uncompetitive and we may be
unable to capture additional market share or may lose market
share. In light of the ongoing consolidation of the industries
in which we operate, we expect that the competitive pressures to
which we are subject will increase in the future.
- 9 -
We operate in many different countries around the world.
As a result, fluctuations in the exchange rates between the euro
and other currencies could adversely affect our results of
operations and reduce our ability to price our products
competitively.
Due to the international scope of our operations, our net sales
and net income may be affected by fluctuations in exchange
rates, particularly between the euro and the U.S. dollar.
An increasing portion of our sales is made in markets outside
the euro zone by our local subsidiaries or through distribution
arrangements. As a result, fluctuations between the euro and the
currencies in these markets may cause our reported revenues to
vary significantly from period to period. For example, the
devaluation of the U.S. dollar against the euro that in
2003 and 2004 had a negative impact on our net sales, especially
our reported sales of Pantoprazole, which is currently our most
important product, in the United States. Although the effect of
this devaluation was in part offset by the appreciation of the
U.S. dollar against the euro in the course of 2005, there
can be no assurance that the U.S. dollar will not
depreciate further in the future. At the same time, a
substantial proportion of our operating costs continues to be
linked to the euro. Accordingly, exchange rate fluctuations have
affected our profitability, and they may continue to do so in
the future.
You should note that in the past each of our subsidiaries was
responsible for managing its own foreign exchange rate exposure.
In 2003, we introduced a uniform hedging strategy for our main
currency exposures, especially our exposure to the
U.S. dollar and currencies linked to the U.S. dollar,
by expanding the time frame for our hedging transactions and the
range of instruments that we use in structuring them. We believe
that this revised strategy has assisted us in better forecasting
our operating results and in limiting our exposure to volatile
exchange rates. Nevertheless, fluctuations in the exchange rates
between the euro and other currencies, particularly the
U.S. dollar, may continue to influence our revenues and
profitability.
In addition to influencing our reported net sales and net
income, exchange rate fluctuations may also impact our
competitive position in countries whose currencies fluctuate
against the euro. In 2004, the strengthening of the euro
relative to the U.S. dollar benefited our U.S.-based
competitors, including in respect of their activities in the
euro zone, and reduced our own pricing flexibility, which
adversely affected the reported revenues and profitability of
each of our segments. While the euro weakened relative to the
U.S. dollar in 2005, it remained relatively strong, and any
further strengthening would reinforce this adverse effect on our
revenue and profitability.
Because we depend on key management, scientific and
technical personnel, our ability to compete would suffer if we
were unable to hire and retain qualified employees.
Our success depends upon the continued contributions of our key
management, scientific and technical personnel, many of whom
have substantial experience with our company and would be
difficult to replace. Competition for qualified personnel is
intense in the industries in which we operate, and we may be
unable to attract the highly qualified employees that our
business requires. If we lose the services of our key management
or scientific and technical personnel or do not succeed in
attracting highly qualified personnel in the future, our
business may be hurt by a reduced ability to compete in the
rapidly evolving markets in which we operate.
Our business will suffer if we are unable to obtain and
defend intellectual property rights or if we do not gain access
to, or are accused of infringing, the intellectual property
rights of others.
Our ability to remain competitive and to capture additional
market share, particularly with respect to our pharmaceuticals
segment, depends in part on our ability to obtain and defend
patents, trademarks and other forms of intellectual property
protection for our products, and on our development and
manufacturing processes and our know-how. While we intend to
prosecute patents vigorously, the process of obtaining patents
is lengthy and expensive. There can be no assurance that patents
will be granted in connection with any of our currently pending
or future applications or that such patents will be valid and of
sufficient scope and strength to provide us with meaningful
legal protection or any commercial advantage. In 2004, generic
drug companies filed Abbreviated New Drug Applications
(ANDAs) with the U.S. Food and Drug
Administration (FDA) in the United States
challenging our Pantoprazole substance patent with a view to
- 10 -
manufacturing and distributing generic versions of Pantoprazole.
In response to one of these challenges, we filed a patent
infringement suit in May 2004 in the U.S. District Court
for the District of New Jersey. Several companies have also
filed ANDAs challenging our Pantoprazole oral formulation
patent. Because Pantoprazole enjoys protection in the United
States under our substance patent until 2010 (and our oral
formulation patent is therefore irrelevant for the time being),
we have decided not to take any immediate action with regard to
these ANDAs. However, in 2005, one of the challengers of our
Pantoprazole oral formulation patent, amended its ANDA to
include a paragraph IV certification relating to our
Pantoprazole substance patent and in addition filed an ANDA
regarding our Pantoprazole intravenous (IV)
formulation patent. As a result, we filed complaints in the
U.S. Federal District Court for the District of New Jersey.
In these complaints, we claim that this competitor is infringing
our substance patent, but consistent with our approach to the
other attacks on our oral formulation patents, do not claim that
our IV formulation patent has been infringed. While we believe
that our U.S. patents relating to Pantoprazole are valid
and enforceable and of sufficient scope and strength to prevent
the entities that have made the filings and any other third
party from manufacturing and distributing Pantoprazole-based
generics at this time, there can be no assurance that we will be
successful in defending our patents. For more information, see
Item 4: Information on the Company
Pharmaceuticals Intellectual Property and
Item 4: Information on the Company Legal
Proceedings.
In addition, intellectual property protection may be unavailable
or limited in some of the countries in which we do business.
Furthermore, a substantial portion of our know-how is not
eligible for patent or comparable forms of intellectual property
protection. To protect this type of information against access
by competitors, we rely on trade secret law and frequently enter
into confidentiality agreements with our employees, customers
and partners. These agreements may be unenforceable, however,
and the remedies available to us for breaches may be inadequate.
Likewise, our competitors may gain access to our know-how by
lawful means, for example, by reverse engineering or by
independently developing the same know-how, which would destroy
any advantage that our know-how may afford us.
Our competitive position may also suffer if competitors come up
with products, development or manufacturing processes or
know-how that is protected by patents, trademarks, licenses or
other forms of intellectual property protection. Technologies
over which our competitors hold intellectual property rights may
either be unavailable to us or be available to us only on
unfavorable terms. To gain access to such technologies, we
sometimes enter into licensing arrangements with third parties.
If our licensing partners were to terminate the licenses that we
have obtained from them or if we are unable to obtain licenses
on commercially favorable terms in the future, our ability to
develop, manufacture and market our present and future products
may be impaired.
While we seek to protect our trademarks, which include the names
of many of our key products, by filing for trademark protection
in most of the countries where we sell these products, you
should note that trademark protection consists primarily of a
right to sue against infringing uses of a mark and, in order to
be effective, requires extensive policing. If we fail to detect
instances of infringement or if we do not succeed in defending
our trademarks in court, our reputation with our customers and
our ability to protect our trademarks in the future may be
harmed.
It may become necessary for us to seek to enforce our patents,
trademarks, licenses and other forms of intellectual property
protection and to protect our trade secrets by taking legal
action or to engage in litigation in order to defend ourselves
against claims of alleged infringement of someone elses
intellectual property brought against us by third parties. There
can be no assurance that we will be able to successfully settle
or otherwise resolve claims that may be brought against us by
third parties in the future. If we are unable to successfully
settle future claims on terms acceptable to us, we may be
required to engage in costly and time-consuming litigation and
may be prevented from, or experience substantial delays in,
marketing our existing pharmaceuticals and launching new ones.
Any of these events could require us to divert substantial
financial and management resources that we would otherwise be
able to devote to our business.
- 11 -
Because our operations are subject to numerous
environmental laws and regulations, we could become exposed to
liability and be required to spend substantial amounts in
connection with environmental compliance or remediation
proceedings.
Our operations are subject to numerous environmental laws and
regulations in the jurisdictions in which we operate. These laws
and regulations govern, among other things, air emissions,
wastewater discharges, the use and handling of hazardous
substances, waste disposal and the investigation and remediation
of soil and groundwater contamination. As with other companies
engaged in activities similar to ours, we face a risk of
environmental liability inherent in our current and historical
manufacturing activities. While we do not believe that any
currently anticipated environmental compliance and remediation
requirements are likely to have a material adverse effect on our
business, financial condition or results of operations, we may
be forced to incur substantial expenses in connection with
future environmental compliance or remediation proceedings, in
which case our results of operations and financial condition may
be materially adversely affected.
We may be faced with product liability claims, which could
impair our reputation in the marketplace and hurt our
profitability.
Although we maintain a comprehensive quality assurance program,
there remains a risk that defects may occur in any of our
products. The occurrence of such defects could give rise to
liability for damages, including consequential and punitive
damages, and could, by impairing our reputation, reduce the
markets acceptance of our products. This risk exists in
each of our segments.
To reduce our exposure to the aforementioned risks, we maintain
an insurance policy covering product liability claims. There can
be no assurance, however, that our insurance policy will be
adequate and sufficient to cover all product liability claims
that may be brought against us or that we will be able to obtain
adequate insurance coverage on commercially reasonable terms in
the future. A successful product liability claim in excess of
our coverage could require us to pay substantial amounts in
damages. In addition, our insurance policy does not protect us
against reputational harm that we may suffer if the market
perceives our products as unsafe or ineffective.
Our business may suffer as a result of volatility in
different parts of the world.
We operate on a global basis. Our business is therefore subject
to a variety of risks inherent in conducting international
operations, each of which could adversely affect our business
and results of operations. These risks include:
|
|
|
|
|
|
|
Wars, terrorist attacks and other hostilities;
|
|
|
|
|
|
Instability of foreign governments;
|
|
|
|
|
|
Changes in domestic or foreign laws or policies affecting
international trade and foreign investment; and
|
|
|
|
|
|
Varying practices of the regulatory, tax, judicial and
administrative bodies in the jurisdictions in which we operate.
|
Risks Related to our Pharmaceuticals Business
Because we depend on the sale of a limited number of key
products to generate a substantial portion of our revenues,
factors adversely affecting the sale of these products could
materially harm our revenues and results of operations.
Like other companies in the pharmaceuticals industry, our
pharmaceuticals division depends on sales of certain key
products that account for a substantial portion of its revenues.
For example, in 2005, our net sales of Pantoprazole, a proton
pump inhibitor (PPI) that we offer for the treatment
of ulcers and reflux disease, accounted for 57.6% of the net
sales of our pharmaceuticals division, or 41.6% of our overall
revenues. Pantoprazole has been a key revenue driver of our
pharmaceuticals division for several years, and we expect that
it will continue to account for a substantial portion of our
revenues in future periods. Despite the launch
- 12 -
of Ciclesonide under the brand name
Alvesco
®
in 2005, we expect to continue to depend on a limited number of
key products for the foreseeable future, particularly following
the termination of our collaboration with Pfizer, Inc.
(Pfizer) and the withdrawal of our European
Marketing Authorization Application (MAA) for
Roflumilast, a drug we are continuing to develop and intend to
market under the brand name
Daxas
®
.
As a result of our dependence on key products, particularly
Pantoprazole, factors adversely affecting the sale of any of
these products could materially adversely affect our revenues
and results of operations. These factors include:
|
|
|
|
|
|
|
Competition from other branded pharmaceuticals that may be
equivalent or superior to our own products or that the market
perceives to be more attractive;
|
|
|
|
|
|
Competition from generic versions of branded pharmaceuticals,
irrespective of the way they are marketed, once the term of
patent protection for the original branded pharmaceuticals has
expired;
|
|
|
|
|
|
Technological advances;
|
|
|
|
|
|
The marketing strategies of our competitors;
|
|
|
|
|
|
Supply chain interruptions;
|
|
|
|
|
|
Work stoppages;
|
|
|
|
|
|
Changes in prescription practices;
|
|
|
|
|
|
Changes in the reimbursement policies of third-party payers; and
|
|
|
|
|
|
Product liability claims.
|
Pantoprazole in particular faces competition from various other
branded PPIs. Most notably, these competitors include
AstraZenecas Esomeprazole and Takedas Lansoprazole.
If our competitors continue to invest heavily in marketing these
products, the ability of Pantoprazole to capture market share or
maintain its current market share could be adversely affected.
In addition, Pantoprazole and other branded PPIs face
competition from generic PPIs, in particular generic PPIs based
on a substance called Omeprazole. A variety of companies are
marketing Omeprazole-based generics in Europe and the United
States at prices that tend to be significantly lower than the
price of Pantoprazole and other branded PPIs. Further
competition may result from the launch of generic PPIs based on
substances other than Omeprazole once the relevant patents have
expired. Pantoprazole also competes with over-the-counter
(OTC) PPIs. Unlike Pantoprazole, these PPIs are
available to patients without a prescription. Various
Omeprazole-based OTC PPIs have been launched in the United
States and several European countries and are being marketed
with increasing success. While generic and OTC PPIs have so far
had a limited impact on the market for branded PPIs, including
Pantoprazole, in Europe, we are experiencing stronger pricing
pressure in the U.S. market with respect to Pantoprazole.
From Pantoprazoles introduction in 2000 until the fall of
2004, the drugs market share in the United States grew,
with temporary interruptions. However, in 2005 as a result of
factors including those described above, Pantoprazoles
share of PPI prescriptions stabilized. Given the increasing
competition from generic and OTC PPIs, there can be no assurance
that Pantoprazoles market share, prescription rates and
net sales contribution will remain at their current levels in
future periods.
Following the expiration of our Pantoprazole substance patent in
most European countries, as extended by supplementary protection
certificates, and the United States in 2009 and 2010,
respectively, we expect our Pantoprazole sales to decrease
substantially.
We depend on Wyeth, Inc. (Wyeth) for the
marketing and distribution of Pantoprazole in the United States.
If Wyeth were to devote insufficient resources to the marketing
of Pantoprazole or if we were to lose Wyeth as a partner, our
sales of Pantoprazole would be adversely affected.
Until June 2003, we marketed Pantoprazole in the United States
exclusively through Wyeth Pharmaceuticals, the pharmaceuticals
division of Wyeth. Since July 2003, our own dedicated sales
force for
- 13 -
the U.S. market has been co-promoting Pantoprazole
alongside Wyeth. While this arrangement has afforded us greater
influence with respect to the marketing of Pantoprazole in the
United States, the revenues that we derive from this drug in the
U.S. market continue to materially depend on the resources
that Wyeth devotes to the marketing of this therapeutic. While
our distribution arrangement with Wyeth requires Wyeth to use
commercially reasonable efforts to sell Pantoprazole, there can
be no assurance that Wyeths marketing efforts will
continue to be successful. In addition, Wyeth is entitled to
terminate its distribution agreement with us under certain
circumstances, including when a third party commences legal
action against Wyeth alleging patent infringement, as well as
without cause upon one years prior written notice. If
Wyeth terminates the contract for reasons other than because we
become insolvent or commit a material breach of the agreement,
it is required to transfer all of its rights pertaining to
Pantoprazole and to products based on this substance, including
any regulatory approvals that it has obtained, to us. See
Item 10: Additional Information Material
Contracts for a summary of the terms of our agreement with
Wyeth. If we were to lose Wyeth as a distribution partner, we
would be forced to find a suitable replacement. If we experience
delays in finding such a replacement, our ability to sell
Pantoprazole in the United States, which accounts for a
substantial portion of our Pantoprazole sales worldwide, would
suffer, and, accordingly, our results of operations would be
adversely affected.
Due to the inherent unpredictability of the process
underlying the development of new pharmaceuticals, there can be
no assurance that we will be able to successfully and timely
launch new drugs and other pharmaceutical products.
A critical element of our future success is the successful and
timely commercial launch of new products. To this end, we devote
substantial resources to research and development and have a
number of promising candidates for new therapeutics in our
pipeline, including a potential next-generation drug for
indications similar to those of Pantoprazole and several
candidates for the treatment of asthma and chronic obstructive
pulmonary diseases (COPD). Because of the
complexities and uncertainties associated with pharmaceutical
research, however, we cannot be certain that any of these drug
candidates will survive the development process and ultimately
obtain the regulatory approvals needed in order to be launched
commercially. Even if the initial results of the development of
a drug candidate are positive, adverse or otherwise
unsatisfactory results remain possible at any time. For example,
in the case of Roflumilast we decided in 2005 to withdraw our
MAA after consulting with the European Medicines Agency
(EMEA) because the clinical record we had
established at the time was less compelling than we had expected.
We may be unable to continue our expansion into the
U.S. market, or our expansion may be delayed, each of which
would limit our growth opportunities.
A key element of the growth strategy of our pharmaceuticals
division is our plan to expand into the United States. The
United States is the biggest pharmaceuticals market in the world
and offers the greatest growth opportunities for our business.
We plan to continue our expansion into the U.S. market with
the assistance of experienced co-promotion partners and by
exploiting the launch of Ciclesonide, which is aimed at the
treatment of respiratory indications, to gradually expand our
own sales and marketing organization for innovative therapeutics
in the United States. This sales and marketing organization
operates separately from our existing U.S. operations for
facial topics and certain other types of pharmaceuticals. While
we made progress in this area in 2005, if Ciclesonide fails to
make it to the U.S. market or to generate sufficient demand
in the United States, or if we were to lose our co-promotion
partner for this drug and were unable to find a suitable
replacement or experience delays in finding a replacement, we
may be unable to continue our expansion in the U.S. market
or may experience delays in doing so. For example, in 2002, we
entered into an agreement with Pharmacia Corporation, which
subsequently was acquired by Pfizer, to co-develop and market
Roflumilast in the United States, which would have enabled us to
further expand our U.S. sales and marketing organization.
However, we mutually agreed in 2005 to terminate this agreement
and, accordingly, will not be able to collaborate with Pfizer in
establishing a sales and marketing organization in regard to
this product. If we do not succeed in securing a strategic
position in this or other international markets, the growth of
our business may be adversely affected. In addition, we may be
unable to recover investments that we have already made in these
markets.
- 14 -
Because our business is subject to extensive governmental
regulation, including price controls, our ability to market our
products is subject to administrative constraints over which we
have only limited influence.
The development, manufacture and marketing of pharmaceuticals
are subject to extensive governmental regulation. Regulatory
approval is required in each jurisdiction in which we operate
before any dosage form of any new pharmaceutical, including an
off-patent equivalent of a previously approved pharmaceutical,
may be marketed in that jurisdiction. The process for obtaining
governmental approval to market pharmaceuticals is rigorous,
time-consuming and costly, and it is impossible to predict the
extent to which this process may be affected by legislative and
regulatory developments. We currently have several projects in
various stages of the approval process in the United States, the
European Union and Japan. If we fail to obtain, or experience
delays in obtaining, regulatory clearance to market new
pharmaceuticals or existing pharmaceuticals for new indications
or if we experience any other regulatory impediments, our
results of operations may be adversely affected. Even after a
pharmaceutical has been approved, it may be subject to
regulatory action based on newly discovered facts concerning its
safety or efficacy. Any such regulatory action may adversely
affect the marketing of our pharmaceutical products, require
changes to their labeling or even force us to withdraw them from
the market altogether.
In addition to the need for obtaining regulatory approval to
market new products, we are subject to price controls imposed by
local governments and health care providers and in some markets
need to obtain special approval before patients are entitled to
be reimbursed for purchasing our products. The existence of
price controls can limit the revenues that we earn from our
products and thus could also have an adverse effect on our
results of operations. The way in which price controls operate
varies by country and can cause substantial disparities in the
price levels prevailing in different markets. Many governments
and private medical care providers, such as Health Maintenance
Organizations (HMOs) and social security
organizations, have introduced or are currently in the process
of introducing reimbursement schemes that favor the replacement
of branded pharmaceuticals by cheaper generic pharmaceuticals.
Since January 1, 2003, the pharmaceuticals industry in
Germany has been required to grant the German public health care
insurance companies (which are the main purchasers of drugs in
the German health care market) fixed mandatory rebates
(
Kassenrabatte
) for most ethical therapeutics. These
rebates, which were increased from 6% in 2003 to 16% in 2004
before again being decreased to 6% in 2005, have, especially in
2004, negatively influenced our pharmaceuticals sales in Germany
when compared to a regulatory environment without such mandatory
rebates. At present, it is unclear to what extent proposed new
legislation, which is aimed at a two-year price moratorium for
all drugs paid for by the statutory health care insurance scheme
(
gesetzliche Krankenversicherung
), will impact our sales
in Germany in the future. In addition, in 2004, new legislation
took effect which provides for the possibility to include
patent-protected drugs in the system of statutory fixed
reference prices certain classes of active ingredients. Drugs
included in the statutory fixed reference price system are not
subject to the fixed mandatory rebates. On January 1, 2005,
Pantoprazole was included in the statutory fixed reference price
system. The association of the German health care insurance
providers has included Pantoprazole in a reference price group
along with other branded PPIs and cheaper Omeprazole-based
generics. In our view, this classification ignores the
substantial therapeutic advantages offered by Pantoprazole
compared with Omeprazole (for example, the fact that
Pantoprazole has less clinically relevant potential for
metabolic interaction with other drugs). While we have lowered
our prices for Pantoprazole in Germany to match the statutory
fixed reference price for this drug so that German patients
insured under the statutory health care insurance scheme
(
gesetzliche Krankenversicherung
) and wishing to purchase
Pantoprazole do not have to pay more than the amount covered by
their respective health insurance policies, we have also filed
suit against the associations decision before the Social
Court in Berlin, Germany. However, there can be no assurance
that we will prevail in this lawsuit.
As a result of these developments, we anticipate that German
regulations will continue to have a negative impact on our
business in Germany. We are also subject to further price
regulations in various other countries, particularly in Europe.
In the United States, generic substitution statutes, which aim
to promote the substitution of original ethical drugs by less
expensive generic drugs, have been adopted in virtually all
states. In addition, the reform of the Medicare system, which
was put in place at the end of 2003, has introduced
pharmaceutical coverage for eligible beneficiaries. While demand
for pharmaceuticals in the U.S. market
- 15 -
could therefore increase significantly, the U.S. government
could use its purchasing power to demand discounts from
pharmaceuticals companies, thereby creating
de facto
price controls on prescription drugs. As a result, we expect
that we will continue to experience pricing pressures, which
could adversely affect our revenues and operating results.
As part of our plans to expand our pharmaceuticals
business, we expect to make substantial investments in
therapeutic areas in which we have limited experience, such as
oncology. If we are unable to develop new drugs in these areas,
we may be unable to recoup our investments.
Our medium- to long-term goal is to expand our pharmaceuticals
business by entering markets in which we are currently not
active. One such market that we may enter is the oncology
market, which we expect will grow substantially in the future.
We have commenced basic oncological research and entered into
R&D collaborations with third parties, and we intend to make
further investments related to oncology over the next several
years. In addition, we may decide to enter other therapeutics
markets, which may require us to make similar investments.
Investments of this sort frequently involve significant cash
expenditures, for example in connection with hiring qualified
scientists, conducting R&D projects and making desirable
acquisitions. In addition, you should note that we have limited
experience with respect to therapeutics that we do not currently
offer. As a result, there can be no assurance that we will be
successful in developing, manufacturing and marketing
therapeutics for new markets or integrating them with our
existing portfolio at all or within a time frame that will
enable us to recoup our initial investments. Any of these risks
may ultimately have an adverse impact on our business, financial
condition and results of operations.
Our R&D strategy involves creating and maintaining
alliances and other collaborative arrangements with third
parties, and any inability to find or retain suitable
collaborators may adversely affect our ability to develop new
pharmaceuticals.
Our continued success will in part depend on our ability to
establish new and to maintain existing collaborations, alliances
and licensing arrangements with third parties, especially with
biotech companies. Collaborations with companies and other
entities that have expertise in biotechnology and genetic
research are of particular importance to our plans to supplement
the existing franchises of our pharmaceuticals business with
therapeutics for oncological indications. We may not be able,
however, to establish and maintain such collaborations on terms
that are acceptable to us or at all. For example, in 2005, we
mutually agreed with Pfizer to terminate our collaboration
agreement with regard to Roflumilast. Moreover, in view of the
ongoing consolidation of the biotech industry, we may experience
greater difficulty finding suitable partners in the future, as a
number of smaller companies, which would be candidates for
collaborations, become part of larger conglomerates that compete
with us and that may be unwilling to grant us access to
attractive technologies on commercially favorable terms or at
all. In addition, we have no control over the amount and timing
of resources that our partners devote to our programs. If we are
unable to form or maintain alliances or our partners fail to
assist us with our R&D efforts, our business may be harmed
and our results of operations may be adversely affected.
Risks Related to our Chemicals Business
Demand for our products could suffer as result of periodic
downturns.
Because the specialty chemicals that we offer are used in a wide
variety of downstream industries served directly or indirectly
by us, including the automotive, construction, electrical
appliances and packaging industries, our results are affected by
the business cycles experienced by these industries. While we
seek to reduce our exposure to these cycles by focusing on
complementary geographic and product markets, there is no
assurance that we will be successful in insulating our chemicals
business from downturns experienced by the industries that it
serves. In addition, we are not immune to negative economic
developments affecting more than one of these industries.
Economic downturns can lead to overcapacity, oversupply, price
pressure, reduced growth and lower margins, each of which could
adversely affect our business and results of operations.
- 16 -
Our results may suffer if we are unable to offset
increases in raw material prices or pass them on to our
customers.
Raw material costs account for a significant portion of the cost
of sales of our chemicals business. The prices and availability
of the raw materials that we use in our chemicals business vary
with market conditions and can be highly volatile. If we are
unable to compensate for increasing raw material prices by
achieving cost savings in other areas or to pass such increases
on to our customers, or if the prices for our products decrease
faster than raw material prices, our profitability may be hurt.
Our ability to pass on raw material price increases depends on a
variety of factors, including the degree to which we are able to
distinguish our products from those of our competitors. In 2005,
we continued to experience high raw material prices, especially
for oil and oil-related products. We continue to attempt to
protect ourselves against these developments by streamlining our
production processes, centralizing our procurement efforts and
substituting more expensive raw materials for cheaper ones.
Nevertheless, we have historically not always been successful in
offsetting the impact of rising raw material prices, and there
can be no assurance that we will be in the future. Even if we
manage to pass on increases in raw material costs to our
customers further increases in raw material prices may have an
overcompensating effect. Therefore, you should be aware that any
movements in the level of the raw material prices that we use in
our chemicals business may have a material impact on our
business, results of operations and financial condition.
Our growth depends in part on our ability to acquire and
successfully integrate companies into our existing
organization.
A key element of the growth strategy of our chemicals division
is to supplement our internal growth with strategic acquisitions
of businesses and technologies that we consider capable of
complementing or enhancing our existing products or of providing
us with access to new markets. As a result, if we are unable to
identify suitable acquisition targets, our growth prospects may
suffer. In addition, in pursuing acquisitions, we may face
competition from other companies operating in the specialty
chemicals and related industries. Our ability to make
acquisitions may be limited also by applicable antitrust,
anti-takeover and other regulations in the United States, the
European Union and any of the other jurisdictions in which we do
business. If any of these risks materializes, we may be unable
to make desirable acquisitions or to complete them on terms
attractive to us. If that occurs, our ability to grow in certain
of our business areas may be adversely affected.
To the extent that we are successful in making acquisitions, we
may have to expend substantial amounts of cash, incur debt,
assume loss-making divisions and incur other types of expenses.
We may also face challenges in successfully integrating acquired
companies into our existing organization. For example, in 2005,
we acquired ECKART GmbH & Co. KG (the ECKART
Group). The acquisition of the ECKART Group was
significantly larger than the acquisitions we had made
previously, and accordingly we may not be as successful in
integrating this business as we have been in similar situations
in the past. Each of these risks may have an adverse effect on
our business, financial condition and results of operations.
Risks Related to Investments in our Company
Because we and our directors and officers are located in
Germany, it may be difficult for you to sue these persons in the
United States or to enforce judgments by U.S. courts
against them.
We are a corporation organized under the laws of the Federal
Republic of Germany, and certain of our directors and executive
officers are residents of Germany. In addition, a substantial
portion of the assets owned by us and the aforesaid individuals
is located outside the United States. As a result, it may be
difficult or impossible for you to effect service of process
upon us or any of the aforesaid persons within the United States
with respect to matters arising under the U.S. federal
securities laws or to enforce against us or any of such persons
judgments of U.S. courts predicated upon the civil
liability provisions of the U.S. federal securities laws.
We have been advised by counsel that it is doubtful as to
whether original actions of liabilities predicated on the
U.S. federal securities laws may be enforced in Germany and
that in Germany both recognition and enforcement of court
judgments with respect to the civil liability provisions of the
- 17 -
U.S. federal securities laws are solely governed by the
provisions of the German Civil Procedure Code
(
Zivilprozessordnung
or
ZPO
). In some cases,
especially when the relevant statutory provisions of German law
do not recognize the international jurisdiction of a
U.S. court or the judgment conflicts with certain basic
principles of German law (for example, the prohibition of
punitive damages and limited pre-trial discovery), a
U.S. judgment might not be recognized by a German court.
Service of process in U.S. proceedings on persons in
Germany, however, is regulated by a multilateral treaty
guaranteeing service of writs and other legal documents in civil
cases if the current address of the defendant is known.
- 18 -