Item 8. Financial Information
Consolidated Financial Statements and Other Financial Information
See Item 18.
Legal Proceedings
Bayer is involved in a number of legal proceedings. As a global company
active in a wide range of life sciences and chemical activities, we may in the
normal course of our business become involved in proceedings relating to such
matters as:
• product liability;
• patent validity and infringement disputes;
• tax assessments;
• competition and antitrust; and
• past waste disposal practices and release of chemicals into the environment.
We cannot predict with certainty the outcome of any proceedings in which
we are or may become involved. An adverse decision in a lawsuit seeking damages
from us, or our decision to settle certain cases, could result in a monetary
award to the plaintiff and, to the extent not covered by our insurance policies,
could significantly harm our business or the result of our operations, financial
positions or cash flows. If we lose a case in which we seek to enforce our
patent rights, we could sustain a loss of future revenue as other manufacturers
begin to market products we developed. In the remainder of this subsection, we
describe what we believe to be the most significant of the proceedings in which
Bayer AG or its subsidiaries are currently involved. The list of cases is not an
exhaustive list of all of the claims that have been made against Bayer AG or its
subsidiaries or of the proceedings in which they are involved, and subsequent
developments in any pending matter, as well as additional claims that may arise
from time to time, including additional claims similar to those described below,
could become significant to Bayer.
Patent validity challenges and infringement proceedings; patent-related
antitrust actions
In the United States, Bayer AG and its U.S. subsidiaries are and have been
plaintiffs or coplaintiffs in a number of patent infringement actions against
generic drug manufacturers. The lawsuits arose because these manufacturers filed
applications in the United States for regulatory approval of generic versions of
products marketed by Bayer or its licensees. Some of these actions have, in
turn, given rise to lawsuits alleging that Bayer AG, Bayer Corporation and other
parties violated federal and state antitrust and similar statutes.
Generic drug manufacturers may receive approval to market formerly
patented products after all applicable patent protections have expired. A
generic drug manufacturer may, however, attempt to avoid a patent prior to its
scheduled expiry by attacking its validity or enforceability. In the United
States, the Federal Food, Drug and Cosmetics Act (the "Act") enables generic
manufacturers wishing to market a bio-equivalent version of another
manufacturer's product to seek regulatory approval by filing an Abbreviated New
Drug Application (ANDA). In its ANDA, the applicant must state the basis on
which it seeks to avoid any applicable patents.
One basis for seeking approval is a claim that the applicant's product
does not infringe existing patent rights or that the patent is invalid or
unenforceable. This claim is commonly known as a "paragraph IV certification" or
"ANDA (IV)". Under the Act, the filing of a paragraph IV certification is deemed
an infringement of patent rights. The Act permits the holder of the patent
rights to file an infringement action against the ANDA applicant within 45 days
of receiving notice of the paragraph IV certification. If the holder of the
patent rights chooses not to file suit within this period, the FDA may approve
the ANDA immediately. The filing of a suit, however, stays
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final FDA approval of the ANDA for a period of 30 months. The court may shorten
or extend this period. If the court rules that the applicant's product will not
infringe the patent or that the patent is invalid or unenforceable, the FDA may
grant approval immediately. If, on the other hand, the court rules that the
product will infringe the patent, the FDA may not grant final approval until the
original patent has expired.
Ciprofloxacin-related actions
Patent-related actions. In January 1997, Bayer AG and Bayer Corporation
settled a patent infringement suit against Barr Laboratories, Inc. This suit
arose when Barr filed an ANDA (IV) seeking regulatory approval of a generic form
of Bayer's ciprofloxacin anti-infective product, which we sell in the United
States under the trademark Cipro. Under the settlement agreement, Barr and Rugby
Laboratories Inc., another generic manufacturer that supported Barr during the
infringement suit, agreed to dismiss the litigation, acknowledging the validity
and enforceability of Bayer's patent rights, and we agreed to pay each company
$24.5 million. The agreement gave us the option, until our patent expired in
2003, to supply Barr and Rugby's then parent company Hoechst Marion Roussel Inc.
with ciprofloxacin products, which they could then market under a license from
Bayer using a single trade name, or alternatively to make quarterly cash
payments. Since concluding the settlement agreement, we have opted to make
payments. As of June 9, 2003, Barr began selling ciprofloxacin hydrochloride
tablets in the United States using licensed product purchased from Bayer. These
purchases are being made pursuant to a separate obligation of Bayer under the
settlement agreement to supply such product to Barr during the six-month period
immediately preceding the December 2003 expiration of the patent protecting the
sale of Cipro in the United States. Bayer has received pediatric exclusivity for
Cipro from the FDA, which will delay the introduction of generic versions of
ciprofloxacin for six months beyond expiration of the patent. The agreement term
has been extended to include the additional six-month pediatric exclusivity
period. Shortly after settling this suit, we applied to the U.S. Patent and
Trademark Office for a re-examination of our patent. The Patent and Trademark
Office reissued the patent in February 1999. See below, - Antitrust actions.
Antitrust actions. Since July 2000, Bayer Corporation has been named as a
defendant in 39 putative class action lawsuits, one individual lawsuit and one
consumer protection group lawsuit filed in a number of state and federal courts
in the United States. Bayer AG has also been named as a defendant in 20 of those
cases, including the individual lawsuit and the consumer protection group
lawsuit; however, to date it has only been served with process in the individual
lawsuit and twelve of the putative class action lawsuits. In addition, Barr
Laboratories, Inc., Aventis S.A., Hoechst Marion Roussel, Inc., Rugby
Laboratories, Inc. and Watson Pharmaceuticals, Inc. have each been named as a
defendant in one or more of these lawsuits. The plaintiffs in these suits allege
that they are direct or indirect purchasers of Cipro who were damaged because
Bayer's settlement of the Barr ANDA (IV) litigation prevented generic
manufacturers from selling a generic version of Cipro. The plaintiffs allege
that the settlement violates various federal antitrust and state business,
antitrust, unfair trade practices and consumer protection statutes, and seek
treble damages and injunctive relief.
The Judicial Panel for Multidistrict Litigation (or MDL Panel) transferred
35 of these cases to the U.S. District Court for the Eastern District of New
York for coordinated pre-trial proceedings. The district court later remanded
nine of those cases to various state courts.
On January 25, 2002, Bayer filed a motion to dismiss all of the cases
pending in the District Court for the Eastern District of New York, and the
plaintiffs filed motions for partial summary judgment that the conduct alleged
in the complaints constitutes an agreement that is unlawful on its face. On
May 20, 2003, the district court denied the plaintiffs' motions for partial
summary judgment, concluding that the alleged conduct was not per se
anticompetitive under U.S. antitrust laws. The district court also denied
Bayer's motion to dismiss, except as to the consumer protection group lawsuit.
Nine cases have been consolidated and are currently pending in a
California state court. The California state court certified a class of certain
indirect purchasers on December 1, 2003 and the defendants appealed that
decision on January 9, 2004. No other court has certified a class. Bayer is also
involved in state court proceedings in Florida, New York, Kansas, Tennessee and
Wisconsin. The New York and Wisconsin cases have been dismissed and plaintiffs
have appealed the dismissal in Wisconsin.
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The Barr settlement is also the subject of an ongoing antitrust
investigation by the U.S. Federal Trade Commission and a number of state
attorneys general.
Because these cases, which may involve joint and several liability among
the defendants, in the aggregate allege substantial unquantified damages and
also seek treble and punitive damages and penalties, it is possible that the
ultimate liability for us could materially adversely affect our results of
operations or cash flows. Although we cannot predict the outcome of these cases
with certainty, we believe that we have meritorious defenses to the antitrust
allegations and intend to defend them vigorously. Additionally, due to the
considerable uncertainty associated with these proceedings, it is currently not
possible to accurately estimate potential liability. Depending on the progress
of the litigation, we will continue to reconsider the need to establish
provisions, which may have a negative effect on our results of operations,
financial position or cash flows.
Moxifloxacin-related actions
In February 2004, Bayer AG and Bayer Corporation received separate ANDA
(IV)s from two generic manufacturers seeking regulatory marketing approval for
allegedly bio-equivalent versions of our respiratory tract anti-infective
product with the brand name Avelox®/Avalox®. Both manufacturers seek the
approval prior to the expiry of the Bayer patents that, among other things,
protect moxifloxacin, the active ingredient of Avelox®. Bayer intends to take
all appropriate legal action to enforce its legal rights.
Nifedipine-related actions
Patent-related actions. Since 1997, Bayer AG and Bayer Corporation have
been involved in a number of patent infringement actions arising from ANDA (IV)s
filed by generic manufacturers seeking regulatory marketing approval for
allegedly bio-equivalent versions of our brand-name product Adalat CC and
Pfizer, Inc.'s brand-name product Procardia XL. The active ingredient of these
products is nifedipine. We own patent rights related to nifedipine drug product
formulations. In addition, because Pfizer markets Procardia XL under a license
from Bayer, Bayer AG and Bayer Corporation became Pfizer's co-plaintiffs in the
infringement actions relating to that product. We have satisfactorily concluded
these cases related to nifedipine with all of the defendants.
Antitrust actions. Biovail filed an antitrust lawsuit against Bayer AG,
Bayer Corporation and Pfizer in the U.S. District Court for the District of
Western Pennsylvania in April 1998. Biovail was seeking a declaratory judgment
that Bayer's nifedipine patents are invalid. Biovail was also seeking damages
under federal and state antitrust statutes alleging, among other things, that
Bayer illegally asserted its patent rights. The district court stayed this
litigation pending resolution of the nifedipine-related patent infringement
actions against Biovail. This suit has been dismissed.
Vardenafil-related actions
On October 22, 2002, a lawsuit (Declaratory Judgment of Infringement of
Pfizer's U.S. Patent number 6,469,012) was filed by Pfizer alleging that Bayer
and GlaxoSmithKline Inc. had and were engaging in activities directed toward
infringement of Pfizer's patent, including seeking FDA approval to market their
co-promoted product, Levitra®. The FDA approved Levitra® for marketing in the
U.S. on August 19, 2003. Bayer and SmithKline Beecham Corporation launched the
product in the U.S. shortly thereafter. On September 22, 2003, Bayer AG and
Bayer Corporation and SmithKline Beecham Corporation were sued by Pfizer Inc.
and certain of its affiliates in the U.S. District Court for the District of
Delaware in conjunction with Pfizer's earlier patent infringement lawsuit
against the same Bayer companies and two different GlaxoSmithKline companies. In
this action, Pfizer alleged that Bayer and GlaxoSmithKline were infringing the
patent by, inter alia, marketing their co-promoted product, Levitra®, for the
treatment of erectile dysfunction. In both, now consolidated, lawsuits, we and
GlaxoSmithKline/ SmithKline Beecham denied the allegations raised by Pfizer and
filed a counterclaim that Pfizer's patent is invalid. We believe that we have
meritorious defenses in these actions and intend to defend them vigorously. In
September 2003, the U.S. Patent and Trademark Office initiated a re-examination
of the Pfizer patent based on questions of patentability in light of prior art.
The litigation has been stayed pending resolution of the re-examination.
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In some other countries further proceedings are pending, in part
infringement actions initiated by Pfizer, in part patent nullity proceedings
initiated by Bayer. In October 2001, the equivalent European Patent held by
Pfizer was revoked by the European Patent Office. Pfizer has appealed against
the decision of the European Patent Office. The proceeding is pending. We do not
expect a final decision before the end of 2004.
Aventis Behring actions
Nattermann & Cie GmbH and Aventis Behring LLC filed a suit on April 11,
2003 against Bayer Corporation and Bayer HealthCare LLC in the U.S. District
Court for the Eastern District of Pennsylvania alleging that Bayer's Kogenate®
FS composition containing recombinant Factor VIII, which is used to treat
hemophilia, infringes upon the U.S. patent owned by either Nattermann & Cie or
Aventis Behring. Bayer counterclaimed, seeking, inter alia, a declaration of
patent invalidity and non-infringement, and asserting that Bayer's use of the
patented process is pursuant to a license. The proceedings are at an early
stage. We believe that we have meritorious defenses in these actions and intend
to defend them vigorously.
Aventis Behring LLC filed a suit on December 4, 2003 against Bayer
Corporation and Bayer HealthCare LLC in the Court of Common Pleas of Montgomery
County, Pennsylvania, alleging that Aventis Behring has been damaged as a result
of Bayer's breach of a contract to supply Aventis Behring with agreed-upon
quantities of recombinant Factor VIII. At the outset, we brought this state
court action to the attention of the federal district court hearing the
Nattermann action described above, arguing this breach of contract claim is a
compulsory counterclaim in the Nattermann action and should be deemed waived
since the deadline for filing such claims in that action has passed, or
alternatively, that Aventis Behring should be required to bring this claim in
the Nattermann action, rather than as an independent action in state court. In
response to federal court directions, the parties have filed briefs on this
issue. We believe we have meritorious defenses and claims in this action and
intend to defend it vigorously. Due to the considerable uncertainty associated
with these proceedings, it is currently not possible to estimate the potential
liability.
Product liability proceedings
HIV/HCV-related actions. During the past decade, Bayer Corporation, as
well as other fractionators of plasma products, have been involved in lawsuits
alleging that hemophiliacs became infected with the human immunodeficiency
virus (HIV), or ultimately developed AIDS, by using clotting factor concentrates
derived from human plasma. Plaintiffs have brought actions on these grounds in
the United States, Ireland, Italy, Taiwan, Argentina, Canada, Japan and Germany.
In the United States, a class action against Bayer Corporation and three
other defendants consolidated the HIV-related claims of more than
6,000 claimants and claimant groups. The parties resolved this class action
through a $600 million settlement. Bayer Corporation's share of this settlement
was approximately $290 million. Bayer Corporation has settled nearly
400 lawsuits by plaintiffs who opted out of the class action. Two suits remain
pending in the United States. Although Bayer Corporation has prevailed in the
majority of cases that have proceeded to trial, plaintiffs were successful in
three cases. The juries in each of these cases awarded damages not exceeding
$2 million. In addition, in 1999, a Louisiana jury awarded a plaintiff damages
of $35 million. However, the trial court set this award aside, and an appellate
court upheld this decision. Bayer Corporation has since settled this matter in
the context of a group settlement of nearly 100 Louisiana cases, of which Bayer
Corporation's share was less than $50 million. Bayer Corporation intends to
defend aggressively the remaining HIV-related lawsuits in various countries. We
have made what we believe to be appropriate provisions should these suits result
in judgments in favor of the plaintiffs.
In June 2003, a U.S. law firm filed a putative class action against Bayer
Corporation and other manufacturers on behalf of non-U.S. residents claiming
compensation for HIV/HCV infections allegedly acquired through blood plasma
products manufactured in the U.S. In September 2003, plaintiffs amended the
complaint to include class action allegations on behalf of U.S. residents
claiming compensation for HCV, hepatitis C virus, infections. The case has been
transferred from the Northern District of California to the U.S. District Court
for the Northern District of Illinois for coordinated discovery and other
pre-trial proceedings. In addition to the June 2003 matter, non-U.S. residents
have filed five and served three additional cases claiming compensation for
HIV/HCV
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infections allegedly acquired through blood plasma products manufactured in the
U.S. Two of these matters have been transferred to the Northern District of
Illinois. These matters are at an early stage. We believe that we have
meritorious defenses to these actions and intend to defend them vigorously. Due
to the considerable uncertainty associated with these proceedings, it is
currently not possible to estimate the potential liability.
Cerivastatin-related actions. In August 2001, Bayer voluntarily ceased
marketing Baycol, the cerivastatin anticholesterol product, in response to
reports of serious side effects in some patients. As of March 5, 2004, 9,948
lawsuits are pending in both federal and state courts, including putative class
actions. The actions in the United States have been based primarily on theories
of product liability, consumer fraud, medical monitoring, predatory pricing and
unjust enrichment. These lawsuits seek remedies including compensatory and
punitive damages, disgorgement of funds received from the marketing and sale of
cerivastatin and the establishment of a trust fund to finance the medical
monitoring of former cerivastatin users. The federal cases were transferred to
the U.S. District Court for the District of Minnesota for coordinated discovery
and other pre-trial proceedings. A motion for certification of nationwide
personal injury, medical monitoring and economic refund classes was denied by
this court on September 17, 2003. Similarly, on December 15, 2003, the Circuit
Court of Cook County, Illinois denied a motion to certify a class action. On
June 16, 2002, the Oklahoma District Court of Pottawatomie County certified a
class of all Oklahoma residents who took cerivastatin and sustained
muscular/skeletal injuries as a result. Bayer appealed this ruling to the
Oklahoma Court of Appeals, which affirmed the lower court's class certification
ruling on June 20, 2003. On November 3, 2003, the Oklahoma Supreme Court denied
Bayer's motion for a writ of certiorari. On March 19, 2004, the Philadelphia
County Court of Common Pleas in Pennsylvania certified a medical monitoring
class of persons in Pennsylvania who took cerivastatin and have not been
diagnosed with the diseases specified in the certification order. We believe
that we have meritorious defenses against class certification and intend to
appeal this ruling. The certification of a class is unrelated to a determination
of our liability. As of March 5, 2004, 93 actions have been initiated against
other companies of the Bayer Group in other countries, including class actions
in Canada. In August 2003, the Supreme Court of British Columbia certified a
class of all persons resident in British Columbia who ingested cerivastatin.
Bayer appealed this ruling and a settlement agreement has been signed in this
matter. Subject to court approval, the settlement agreement provides for a
decertification of the class proceeding for all persons included in the original
class who did not suffer from rhabdomyolysis. Bayer expects additional lawsuits
to be filed in the United States and elsewhere. Three U.S. cases have been tried
to date, all of which resulted in a verdict in our favor.
In negotiations with the insurance companies concerning the cerivastatin
litigation, an agreement was reached with the majority of the insurers. The
insurers had previously proceeded only on a provisional basis under a customary
reservation of rights. The insurers that are parties to this agreement have now
withdrawn the reservations of rights. Thus, Bayer expects the insurance coverage
for cerivastatin to be approximately $1.2 billion. Based on the agreement
reached with the insurers and in consideration of further expected settlements
and further defense costs, the Company has taken accounting measures, which
resulted in a charge to income of €300 million for the fiscal year 2003.
Due to the considerable uncertainty associated with these proceedings, it
is currently not possible to estimate the potential liability and thus no
provisions exceeding the expected insurance coverage and the above referenced
accounting measures already taken have been made. Depending on the progress of
the litigation, Bayer may face payments that exceed our expected insurance
coverage and the above referenced accounting measures and will continue to
reconsider the need to establish additional provisions, which may have a
negative effect on the results of our operations, financial positions or cash
flows. Without acknowledging any liability, we have settled 2,224 cases in the
United States as of March 5, 2004, resulting in settlement payments of
approximately $842 million.
In January and March 2004, Bayer signed settlement agreements with lawyers
representing plaintiffs in Baycol litigation pending in Canada. The agreements
together establish a procedure to settle claims of rhabdomyolysis for all
Canadian residents. To facilitate an efficient implementation of the agreement,
the parties have agreed to a settlement class which is subject to approval by
the courts. Bayer will continue to offer fair compensation to people who
experienced serious side effects while taking cerivastatin on a voluntary basis
and without concession of liability. In cases where an examination of the facts
indicates that Baycol played no part in the patient's medical situation, or
where a settlement is not achieved, Bayer will continue to defend itself
vigorously. Bayer believes it has meritorious defenses in these actions. In some
countries, criminal proceedings
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have been initiated by the relevant authorities. In the United States, Bayer
co-promoted this product with SmithKline Beecham Corporation. SmithKline Beecham
Corporation and Bayer Corporation have signed an allocation agreement under
which SmithKline Beecham has agreed to pay 5 percent of all settlements and
compensatory damage judgments arising out of actions based on the sale or
distribution of cerivastatin in the United States, with each party responsible
for paying its own attorneys' fees.
In January 2004, Bayer Corporation received a subpoena for documents
principally relating to cerivastatin from the Defense Criminal Investigative
Service of the U.S. Department of Defense Inspector General. Prior to the
withdrawal, Bayer had a contract with the Department to provide it with a supply
of cerivastatin. Preliminary conversations with the Justice Department indicate
that this is a joint Department of Defense/Food and Drug Administration
investigation relating to cerivastatin. Bayer is not aware of any charges or
complaints filed in connection with this inquiry. Bayer believes it has acted
responsibly and fulfilled its responsibilities to the U.S. government, and will
work cooperatively to provide the information requested.
Phenylpropanolamine (PPA) actions. In late 2000, Bayer voluntarily
discontinued marketing over-the-counter cough and cold remedies containing PPA
in the United States in response to a recommendation from the FDA that
manufacturers voluntarily discontinue marketing products containing PPA. Bayer
also voluntarily discontinued marketing products containing PPA in Canada and in
various Latin American countries in late 2000 and in Spain in 2001. The FDA
issued this recommendation after one epidemiological study of a small number of
patients suggested a possible association between PPA and hemorrhagic stroke in
women of certain ages. As of March 5, 2004, approximately 1,500 lawsuits are
pending in the United States against Bayer Corporation. Of these, approximately
850 cases name Bayer as the only manufacturing defendant. In the remaining 650
cases, one or more other manufacturers are also defendants. As of March 5, 2004,
Bayer AG has been named as a defendant in 43 of these individual cases; however,
plaintiffs have agreed not to actively pursue their claims against Bayer AG at
this time. The MDL Panel has assigned management of the federal court cases to
the U.S. District Court for the Western District of Washington. Additionally,
two purported class action suits against Bayer Corporation are currently pending
in Pennsylvania and New Jersey. There has been little activity in these cases
since they were filed in 2001. Class certification was denied in a total of
twelve cases. A class certification was denied in an economic injury case
brought in California. Plaintiffs appealed but later voluntarily dismissed their
appeal, which the court approved in September of 2003. In another economic
injury class action case, which was part of the multi-district litigation
proceeding, class certification was denied and that decision affirmed on appeal.
The claims primarily relate to compensation for alleged damage to health
and personal injury, breach of warranty, negligent and reckless
misrepresentation, entitlement to subsequent monitoring and reimbursement of the
purchase price, and conspiracy to defraud and fraudulently conceal. Claims for
punitive damages have also been filed. It is probable that additional actions
will be initiated in the United States or in other jurisdictions where products
containing PPA were marketed. Bayer believes it has meritorious defenses to
these actions and intends to defend them vigorously. Bayer will, at times,
consider the option of settling litigation on a case-by-case basis and, without
acknowledging any liability, has recently settled a number of cases.
Due to the considerable uncertainty associated with these proceedings, it
is currently not possible to estimate potential liability and thus no provisions
for such potential liabilities have yet been made. Depending on the progress of
the litigation, Bayer may face payments that exceed our insurance coverage and
will continue to reconsider the need to establish provisions, which may have a
negative effect on the results of our operations, financial positions or cash
flows.
Thimerosal actions
As of March 12, 2004, Bayer Corporation has been served in 24 lawsuits
filed in various state and U.S. federal courts by or on behalf of persons
alleging injuries from use of Bayer products containing thimerosal or
phenylmercuric acetate, specifically immunoglobulin injectable products and
over-the-counter nasal sprays. Many of these cases involve multiple unrelated
plaintiffs. Numerous manufacturers used mercury-containing compounds as
preservative agents in vaccines and other medical and over-the-counter products.
Plaintiffs allege that use of products containing these compounds has caused
autism, neurodevelopmental disorders and other injuries. They are requesting
various remedies for the alleged resulting injuries including compensatory,
punitive
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and statutory damages and funding for medical monitoring and research.
Additional cases may be filed in the future against Bayer and other companies
that sold products using mercury-containing compounds. The cases against Bayer
are at an early stage, and Bayer is contesting them on both procedural and
substantive grounds. Bayer believes it has meritorious defenses in these actions
and intends to defend them vigorously. Due to the considerable uncertainty
associated with these proceedings, it is currently not possible to estimate the
potential liability.
Everest litigation
The purchaser of Bayer CropScience's global Everest herbicide business,
Arvesta, has filed a lawsuit in California demanding rescission of the asset
purchase agreement in connection with the purchase of Everest and return of the
purchase price or, alternatively, monetary damages. Arvesta alleges that Bayer
CropScience withheld material information concerning the value of certain claims
resulting from Everest use in Idaho and that Bayer CropScience misled Arvesta
about the amount of Everest that had been used in Canada in 2002 and perhaps
other years. Bayer CropScience is currently preparing its responsive pleadings.
Imidacloprid actions
The French registration on Maize of the Bayer CropScience product
containing imidacloprid, Gaucho®, is being challenged by the Union Nationale de
l'Apiculture Francaise (UNAF), a national association of beekeepers in France,
due to alleged bee toxicity. The French Ministry of Agriculture refused to
withdraw the registration in January 2003 and UNAF appealed. An adverse decision
could adversely affect results of operations and cash flows. The French Ministry
of Agriculture has recently requested an additional review of imidacloprid
product registrations, which is currently ongoing. No new adverse findings have
been presented to date.
In the United States, owners of honeybees and honeybee hives have filed a
purported class action against Bayer in federal court in Pennsylvania as well as
a corresponding action in Pennsylvania state court alleging that imidacloprid
caused damage to their honeybees, to the honey as well as to the wax. The
federal court dismissed without prejudice plaintiffs' motion to certify a class.
These proceedings are at various preliminary stages. It is not possible to
estimate potential liability in these cases. Bayer believes it has meritorious
defenses in these actions and intends to defend them vigorously.
BASF Fipronil Claim
BASF has notified Bayer CropScience AG of a claim, which is based on the
allegation that Bayer CropScience AG in connection with the sale of its fipronil
business to BASF willfully misled BASF by not disclosing updated business
developments with respect to fipronil in Brazil and Korea in the third quarter
of 2002 and not disclosing updated business expectations for 2003 and the
following years. Discussions between the parties are ongoing. Bayer believes it
has meritorious defenses in this action and intends to defend it vigorously. Due
to the considerable uncertainty associated with these proceedings, it is
currently not possible to estimate the potential liability.
Average wholesale price manipulation proceedings
Sixteen pending lawsuits allege that a number of pharmaceutical companies,
including Bayer Corporation, manipulated the average wholesale price ("AWP")
and/or Medicaid best price of their products. The suits allege that this
manipulation resulted in overcharges to Medicare beneficiaries, Medicaid
recipients, state governmental health programs, and private health plans. These
suits generally seek damages, treble damages, disgorgement of profits,
restitution and attorneys' fees. Ten of the sixteen actions are private class
actions alleging injury to patients or payors. The remaining six are brought by
government entities. All of the state court actions have been removed to federal
court; two of the cases have been remanded back to state court in Arizona and
Nevada.
The thirteen cases pending in the federal courts have been consolidated in
the U.S. District Court for the District of Massachusetts for coordinated
pre-trial proceedings. One of the federal suits names Bayer AG together with
Bayer Corporation as defendants.
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In June 2003, plaintiffs filed an Amended Master Consolidated Complaint
governing most of the private party class actions pending against Bayer. Bayer,
along with other defendants, moved to dismiss that complaint. On February 24,
2004, the court granted the defendants' motion in part and denied it in part,
dismissing the first count of the ten-count complaint. Bayer anticipates
commencing discovery in the near future.
Due to the considerable uncertainty associated with these proceedings, it
is not possible to estimate potential liability. Depending on the progress of
the proceedings, we will continue to reconsider the need to establish
provisions, which may have a negative effect on the results of our operations,
financial positions or cash flows.
Rubber-related actions
Bayer AG and certain of its subsidiaries are the subjects of criminal and
civil investigations being conducted by the Antitrust Division of the
U.S. Department of Justice ("DOJ"), the Directorate General for Competition of
the European Commission ("EC"), and the Canadian Competition Bureau ("CCB", and,
collectively, the "Competition Authorities"). The Competition Authorities are
investigating potential violations of their respective antitrust or competition
laws involving certain of Bayer's rubber-related lines of business.
Since September 2002, the DOJ has undertaken criminal grand jury
investigations of potential antitrust violations involving Bayer's rubber
chemicals, ethylene propylene diene monomer ("EPDM") synthetic rubber, and
acrylonitrile butadiene rubber ("NBR") synthetic rubber lines of business. The
EC is conducting civil investigations of potential violations of European
competition laws involving Bayer's rubber chemicals, EPDM and NBR lines of
business. The CCB is conducting criminal investigations of potential violations
of Canadian competition laws involving Bayer's rubber chemicals, EPDM and NBR
lines of business.
Bayer and certain of its subsidiaries have been named, among others, as
defendants in multiple putative class action lawsuits in various state courts in
the United States and as defendants in lawsuits pending before various federal
courts in the United States. In each state court action, the plaintiffs have
alleged violations based on the defendants' alleged participation in a
conspiracy to fix prices. The state court plaintiffs seek damages as indirect
purchasers of the allegedly affected products. In the federal court actions, the
plaintiffs allege the defendants' participation in a conspiracy to fix the
prices and/or to allocate markets and customers for the sale of the allegedly
affected products and seek damages as direct purchasers of those products. These
proceedings are at various preliminary stages.
Bayer is aware that its competitors are subject to investigations by the
Competition Authorities involving potential violations of antitrust or
competition laws related to additional rubber-related products. Private civil
lawsuits may arise out of these investigations, which may involve Bayer and its
competitors.
Because these cases, which may involve joint and several liability among
the defendants, in the aggregate allege substantial, unquantified damages and
also seek treble and punitive damages and penalties, it is possible that the
ultimate liability could be materially adverse to our results of operations,
financial position or cash flows in one or more periods. Additionally, due to
the considerable uncertainty associated with these proceedings, it is currently
not possible to estimate potential liability. Depending on the progress of the
litigation, we will continue to reconsider the need to establish or adjust
provisions, which may have a negative effect on the results of our operations,
financial positions or cash flows.
Polyester polyols investigation
Bayer's U.S. subsidiary, Bayer Corporation, is the subject of a criminal
antitrust investigation by the Antitrust Division of the DOJ. The Division is
investigating potential antitrust violations involving certain of Bayer
Corporation's polyester polyols lines of business. This matter is at an early
stage. It is not possible to estimate potential liability in this matter.
Securities litigation
Bayer AG, along with certain of its current and former officers and
members of the Bayer AG Board of Management, and Bayer Corporation have been
named as defendants in a purported class action lawsuit pending in the
U.S. District Court for the Southern District of New York. The class action
alleges violations of the
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U.S. securities laws and asserts that the defendants made false and misleading
statements and omissions with respect to the commercial prospects, safety and
efficacy of our cerivastatin anticholesterol products and with respect to the
extent of the potential product liability exposure following our voluntary
decision to cease marketing and to withdraw these products in August 2001. The
case seeks damages on behalf of class members who allegedly purchased Bayer
securities at inflated prices. The case results from court consolidation on
June 27, 2003 of seven purported class action lawsuits that had been filed on
related grounds. In consolidating the seven cases, the court appointed a lead
plaintiff and lead plaintiff's counsel. On October 31, 2003, the lead plaintiff
filed a consolidated amended complaint seeking unspecified damages on behalf of
a class of all persons who purchased Bayer AG stock (including Bayer AG American
Depository Receipts) between March 6, 1998 and February 21, 2003. Defendants
filed a motion to dismiss the consolidated amended complaint on January 15,
2004. The court has not yet ruled on this motion. Bayer AG, as do the other
defendants, denies liability, believes that it has meritorious defenses to this
action and intends to defend itself vigorously. Due to the considerable
uncertainty associated with these proceedings, it is currently not possible to
estimate the potential liability.
German shareholder lawsuit
In June 2003, a shareholder of Bayer AG filed a lawsuit in the regional
court of Cologne, Germany (Landgericht Köln) challenging certain resolutions
approved by the shareholders' meeting of April 25, 2003, including the financial
statements of Bayer AG (not the consolidated financial statements) and
consequently the distribution of profits. In effect, the plaintiff sought to
prevent the implementation of our planned new corporate structure. The lawsuit
was withdrawn by the shareholder in July 2003.
Asbestos litigation
We are currently involved in asbestos litigation in the United States,
primarily as a premises defendant, predominantly in the states in which Bayer
has industrial sites. The overwhelming majority of cases involving Bayer have
been filed in West Virginia and Texas and involve allegations of exposure at
Bayer's sites. There are also some asbestos cases pending against Bayer in
Indiana and California. Texas law and West Virginia law permit consolidated
asbestos actions in which multiple plaintiffs can sue multiple defendants for
asbestos-related conditions without specifying which plaintiff has a claim
against which defendant. While Bayer may be named as a defendant, each plaintiff
does not have to assert a claim against Bayer.
The allegations as to Bayer and numerous other premises defendants are
that Bayer employed many contractors on our industrial sites, yet failed to warn
them or protect them from the known hazards of asbestos exposure throughout the
1960's, 1970's and 1980's. Since premises owners now form a new group of
targeted corporate defendants in these litigations, these types of actions may
have an adverse impact on our results of operations, financial position or cash
flows.
One of our U.S. subsidiaries, Bayer CropScience, Inc., is the legal
successor to entities that sold asbestos-containing products from the 1940's
until 1976 and is named as a defendant in asbestos-related litigation. Bayer
CropScience is and has been fully indemnified for its costs and exposure in
relation to this litigation by Union Carbide. Union Carbide continues to accept
Bayer CropScience's tender of these cases, and it defends and settles them in
Bayer CropScience's name, in its own name and in the name of the several
predecessor companies to Bayer CropScience.
We believe that we have meritorious defenses in these actions and are
defending them vigorously. Without acknowledging any liability, we have settled
a number of these cases in the past. We may, on a case-by-case basis, settle
additional cases for reasonable amounts when, in our judgment, settlement is
economically feasible given the risks and costs inherent in the litigation. We
have made what we believe to be appropriate provisions should these suits result
in judgments in favor of the plaintiffs.
Plant Genetic Systems litigation
Former shareholders of Plant Genetic Systems NV ("PGS") have initiated
arbitration proceedings in the Netherlands against AgrEvo, now Bayer CropScience
GmbH. Claimants sought damages of up to $400 million based on alleged violations
of a confidentiality agreement in connection with the acquisition of PGS by
AgrEvo
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in 1996, which allegedly prevented claimants from obtaining a higher purchase
price. By judgment of August 1, 2003, the Arbitration Court finally and
completely rejected all claims by former PGS shareholders.
Dividend Policy and Liquidation Proceeds
Our shareholders may declare dividends at an ordinary general
shareholders' meeting, which must be held within the first eight months of each
fiscal year.
Under German law, Bayer AG may pay dividends only from balance sheet
profits reflected in its unconsolidated financial statements (as opposed to the
consolidated financial statements of the Bayer Group), as adopted and approved
by the Board of Management and the Supervisory Board. In determining the balance
sheet profits that may be distributed as dividends, the Board of Management may
under German law and the provisions of our Articles of Association allocate to
other retained earnings (andere Gewinnrücklagen) the net income of Bayer AG for
the fiscal year that remains after deducting amounts to be allocated to legal
and statutory reserves (gesetzliche Rücklagen) and losses carried forward. More
than 50 percent of the net income may be allocated to other retained earnings
only if such retained earnings would then not exceed 50 percent of our capital
stock. The Board of Management may also increase balance sheet profits when
preparing the financial statements with funds withdrawn from retained earnings.
Our shareholders, in their resolution on the appropriation of balance
sheet profits, may carry forward balance sheet profits in part or in full and
may allocate additional amounts to retained earnings. Profits carried forward
will be automatically incorporated in the balance sheet profits of the next
fiscal year and may be used in their entirety to pay dividends in the next
fiscal year. Amounts allocated to the retained earnings are available for
dividends only if and to the extent the retained earnings have been dissolved by
the Board of Management when preparing the financial statements, thereby
increasing the balance sheet profits.
Dividends approved at an ordinary general shareholders' meeting are
payable promptly after the meeting, unless otherwise decided at the meeting.
Because all of Bayer AG's shares are in book-entry form represented by a global
certificate deposited with Clearstream Banking AG in Frankfurt am Main, Germany,
shareholders receive dividends through Clearstream for credit to their deposit
accounts. Additionally, the ordinary general stockholders' meeting may decide to
distribute the balance sheet profit partly or in total to the stockholders by
way of distribution in kind.
We expect to continue to pay dividends, although we can give no assurance
as to the payment of a dividend for any particular year or as to the particular
amounts that we may pay from year to year.
Apart from liquidation as a result of insolvency proceedings, Bayer AG may
be liquidated only with a combined majority of the votes cast and three-quarters
of the share capital present or represented at a shareholders' meeting at which
the vote is taken. In accordance with the German Stock Corporation Act, upon a
liquidation of Bayer AG, any liquidation proceeds remaining after paying off all
of Bayer AG's liabilities would be distributed among the shareholders in
proportion to the total number of shares held by each shareholder.
See also Item 3, Key Information - Dividends.
Significant Changes
Except as discussed elsewhere in this annual report, no significant change
has occurred since the date of the annual financial statements included in this
annual report.
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