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| BOL > SEC Filings for BOL > Form 10-K on 7-Feb-2007 | All Recent SEC Filings |
7-Feb-2007
Annual Report
This management's discussion and analysis of financial condition and results of
operations (MD&A) should be read in conjunction with the accompanying financial
statements of Bausch & Lomb Incorporated ("Bausch & Lomb," "we," or "the
Company"). All dollar amounts in this MD&A, except for per share data, are
expressed in millions unless specified otherwise, and earnings per share are
presented on a diluted basis.
The MD&A includes a non-GAAP constant-currency measure which we use as a key
performance metric in assessing organic business growth trends.
Constant-currency results are calculated by translating actual current- and
prior-year local currency revenues and expenses at the same predetermined
exchange rates. The translated results are then used to determine year-over-year
percentage increases or decreases that exclude the impact of currency. Since a
significant portion of our revenues are derived in markets outside the United
States, we monitor constant-currency performance for Bausch & Lomb in total as
well as for each of our business segments. In addition, we use constant-currency
results to assess non-U.S. operations' performance against yearly targets for
the purpose of calculating bonuses for certain regional employees.
All figures and comparisons in this MD&A reflect restatements of our financial
results from 2001 through the second quarter of 2005 that are more fully
described in the Recent Developments section below and in Item 8. Financial
Statements and Supplementary Data under Note 2 - Restatement of this Annual
Report on Form 10-K. The cumulative impact of restatement adjustments increased
prior-2001 net earnings by $34.
As more fully described in the Recent Developments section and in Item 8.
Financial Statements and Supplementary Data under Note 23 - Subsequent Event, of
this Annual Report on Form 10-K following the close of fiscal year 2005, but
prior to the filing of this Annual Report on Form 10-K, we instituted a
worldwide recall of ReNu with MoistureLoc contact lens care solution
(MoistureLoc). Certain charges associated with this recall were recorded as part
of 2005 operating results, while others will be recorded in 2006. In the
discussion of 2005 operating performance which follows, we have quantified the
charges, and in some cases have provided certain information about growth rates
and operating ratios prior to the recording of the charges. We believe this
additional disclosure is useful and relevant because it provides a basis for
understanding underlying business performance independent of this unusual
situation.
Additionally, during the third quarter of 2005 we disposed of our Woehlk contact lens business in Germany, and in the fourth quarter of 2005 we completed the acquisition of Freda, a Chinese ophthalmic pharmaceuticals company. These events impacted the reported growth rates for our regions and product categories. In certain instances in the discussion of 2005 operating performance which follows, we have disclosed growth rates for the total company, Europe and Asia regions, as well as the contact lens and pharmaceuticals product categories, that are calculated by removing incremental revenues associated with Freda from 2005 and revenues associated with Woehlk from both 2005 and 2004. We believe this additional disclosure is useful and relevant because it provides a basis for understanding and assessing underlying performance of those portions of our business which were fully in place for both periods.
Business Overview
Bausch & Lomb is a global eye health company dedicated to perfecting vision and
enhancing life for consumers around the world. We develop, manufacture and sell
contact lenses and lens care products, ophthalmic pharmaceuticals and products
used in ophthalmic surgery. With products available in more than 100 countries,
the Bausch & Lomb name is one of the best known and most respected eye health
brands in the world.
Our fiscal quarter consists of 13 weeks, whereby the first and second months of
each quarter contain four weeks of results and the third month of each quarter
contains five weeks of results. Accordingly, net sales are typically higher in
the third month of any given quarter. In addition, the execution of a broad
portfolio of our customer incentive programs typically has been higher at the
end of each quarter.
We closely monitor and evaluate customer incentives and other customer programs,
such as extended credit terms. Should we determine that certain customer
programs result in excessive levels of inventory in certain channels of trade
(such as retailers, mass merchandisers, wholesalers and distributors) or the
risks and rewards have not transferred to the customer, net sales in conjunction
with the associated programs would be accounted for as consignment sales. Our
revenue recognition policy is further discussed in Item 8. Financial Statements
and Supplementary Data under Note 1 - Significant Accounting Policies of this
Annual Report on Form 10-K.
We manage the business through five business segments. These include three
regional commercial segments (the Americas; Europe, Middle East and Africa
[Europe]; and Asia); and two centralized functions (Global Operations &
Engineering and Research & Development). The Global Operations & Engineering
segment is responsible for manufacturing, distribution, logistics and
engineering activities for all product categories in all geographies. The
Research & Development segment has global responsibility across all product
categories for product research and development, clinical and medical affairs,
and regulatory affairs and quality.
Because our products are sold worldwide (with approximately 60 percent of sales
derived outside the United States), our reported financial results are impacted
by fluctuations in foreign currency exchange rates. At the net sales line, our
greatest translation risk exposures are principally to the euro and the Japanese
yen. At the earnings level, we are somewhat naturally hedged to the euro because
top-line exposures are offset by euro-denominated expenses resulting from
manufacturing, research and sales activities in Europe. In general, we do not
use financial instruments to hedge translation risk, other than occasionally for
the yen. In each of the three years discussed in this MD&A, foreign currency
fluctuations have generally provided positive benefits to reported results as
compared to constant-currency results, although that trend began to reverse in
the second half of 2005.
The eye health market is intensely competitive, characterized by continuous
product development, frequent new product introductions and price competition.
Our goal is to build upon our already strong presence in this market by:
· focusing on research and development programs to yield a robust pipeline;
· expanding the geographic reach of key products, especially in under-penetrated markets;
· enhancing our organizational capabilities by further implementing disciplined business processes in all areas, particularly sales; and
· protecting the equity represented by the Bausch & Lomb brand. In the shorter term, this will include activities to rebuild that equity in certain markets where brand image has suffered following the outbreak of fungal infections among contact lens wearers and the MoistureLoc recall.
We expect drivers of sales and earnings growth over the next several years to include:
· a continued focus on faster growing business segments and the launch of higher-margin new products in each of our product categories;
· favorable demographic trends, such as the aging of the population and an increase in the incidence of myopia and presbyopia; and
· opportunities to further implement Lean manufacturing techniques and other cost improvements to enhance margins, particularly for contact lenses and intraocular lenses.
We remain focused on bringing innovations to the market to sustain and improve
our leading positions and improve overall profitability. Our success and future
growth depend, in part, on whether we can develop, efficiently manufacture and
effectively market products for the treatment of eye conditions that incorporate
the latest technologies.
We devote substantial resources to research and development (R&D). We currently
hold approximately 2,100 patents and have approximately 1,900 pending patent
applications. The R&D process is expensive, prolonged and entails considerable
uncertainty. Because of the complexities and uncertainties associated with
ophthalmic R&D, products currently in development may take years to complete, or
may not complete the development process or obtain the regulatory approvals
required to market them.
Our ability to maintain operating margins (defined as operating income divided
by net sales) may be affected by regulatory actions, particularly for
pharmaceutical and surgical products. Further, managed care organizations and
governments continue to emphasize the delivery of more cost-effective medical
therapies. Many third-party payers for hospital services have substantially
revised their payment methodologies in recent years, resulting in stricter
standards for reimbursement of hospital and outpatient charges.
To offset these developments, we are intensely focused on improving
manufacturing efficiency and controlling costs. We believe the profitability
improvement initiatives in place since mid-2002 yielded an infrastructure
capable of supporting a much higher revenue base than we have historically
experienced. Manufacturing initiatives that incorporate Lean principles and
automation have yielded gross margin improvements. Our goal also is to manage
selling, administrative and general expenses to help support increased levels of
R&D spending. Together, these activities are designed to further increase
operating margins in the future.
Recent Developments
Restatement of Financial Information As previously disclosed in our Notification
of Late Filings on Form 12b-25 with the Securities and Exchange Commission (SEC)
on March 17, 2006, May 11, 2006, August 8, 2006 and November 9, 2006, we were
unable to file this Annual Report on Form 10-K on a timely basis due to ongoing
independent investigations conducted by the Audit Committee of our Board of
Directors; expanded year-end procedures that were not complete; expanded
procedures with respect to the accounting for income taxes that were not
complete; and continued efforts to complete our assessment of our internal
control over financial reporting. Our review and evaluation of internal control
over financial reporting concluded that we did not maintain effective internal
control over financial reporting as of December 31, 2005. For additional
information regarding our assessment of internal controls, see Item 9A. Controls
and Procedures of this Annual Report on Form 10-K.
As a result of the Audit Committee's investigations and the expanded year-end
procedures and expanded procedures with respect to the accounting for income
taxes, we identified errors made in the application of generally accepted
accounting principles (GAAP) that impacted previously reported financial
statements. Consequently, management determined that our previously issued
consolidated financial statements for fiscal years 2003 and 2004 and our
financial information for the years ended 2001 and 2002 (including a cumulative
increase to 2001 beginning retained earnings of $34) and the first and second
quarters of 2005 should be restated to correct for such errors and departures
from GAAP. The restated financial statements contained in this Annual Report on
Form 10-K contain a number of adjustments associated with revenue recognition,
accounting for reserves, accounting for foreign currency adjustments, accounting
for income taxes including income taxes payable, tax reserves, deferred income
tax assets and liabilities, related valuation allowances and income tax expense,
and the accounting for the Company's Long-Term Deferred Compensation Plan. For
further details regarding the Audit Committee investigations and restatement of
financial results, see Item 8. Financial Statements and Supplementary Data under
Note 2 - Restatement and Note 22 - Quarterly Results, Stock Prices and Selected
Financial Data (Unaudited) of this Annual Report on Form 10-K.
Market Withdrawal of MoistureLoc On May 15, 2006, we announced a worldwide
voluntary recall of MoistureLoc. Our decision was made following an
investigation into increased fungal infections among contact lens wearers in the
United States and certain Asian markets. The decision represents a subsequent
event occurring prior to filing this Annual Report on Form 10-K, but related to
product manufactured and sold in 2005. In accordance with GAAP, we have recorded
certain items associated with the recall in our 2005 financial results. The
adjustments were recorded as third-quarter events, because that is the earliest
reporting period for which we have not filed quarterly financial results on a
Quarterly Report on Form 10-Q.
The charges associated with the withdrawal reduced full-year 2005 earnings
before income taxes and minority interest by $39, net income by $27, and
earnings per share by $0.49. Of the pre-tax amount, $17 related to estimated
customer returns and consumer rebates and was recorded as a reduction to net
sales; $14 related to costs associated with returned product and the disposal
and write-off of inventory, which was recorded as cost of products sold; and $8
related to costs associated with the notification to customers and consumers
required in market withdrawal instances, which were recorded as selling,
administrative and general expense. Charges include $2 for settled, unlitigated,
claims; however, we have not recorded any provisions for potential legal actions
related to MoistureLoc because we are not able to predict the outcome of such
actions, if any (see further discussion in Item 3. Legal Proceedings, and in
Item 8. Financial Statements and Supplementary Data under Note 21- Other Matters
of this Annual Report on Form 10-K and the discussion in Legal Matters below).
The decision to withdraw the product will negatively impact 2006 financial
performance, and likely beyond. In addition to provisions for sales returns and
coupon redemptions that we will record in 2006 associated with the MoistureLoc
recall (primarily in Europe), performance will be hampered by the impact from
lost MoistureLoc revenues; lower revenues for other lens care products,
reflecting market share losses caused by trade and consumer uncertainty;
negative collateral effect on our non-lens care product categories, primarily in
Asia; and higher expenses associated with the recall, legal expenses associated
with product liability lawsuits, and increased promotional expense to regain
distribution and brand equity in the lens care category. For an additional
discussion on the market withdrawal of MoistureLoc lens care solution, see Item
8. Financial Statements and Supplementary Data under Note 23 - Subsequent Event
of this Annual Report on Form 10-K.
Legal Matters The Company is involved as a party in a number of material matters in litigation, including general litigation related to the restatement of the Company's financial information and the MoistureLoc withdrawal, material intellectual property litigation, and material tax litigation. The Company intends to vigorously defend itself in all of these matters. At this time, the Company is unable to predict the outcome of, and cannot reasonably estimate the impacts of, any pending litigation matters, matters concerning allegations of non-compliance with laws or regulations, and matters concerning other allegations of other improprieties. The Company has not made any financial provision for potential liability in connection with these matters.
Shareholder Securities Class Actions There is a consolidated securities class
action, entitled In re Bausch & Lomb Incorporated Securities Litigation, Case
Nos. 06-cv-6294 (master file), 06-cv-6295, 06-cv-6296, and 06-cv-6300, pending
in Federal District Court for the Western District of New York, Rochester
Division, against the Company and certain present and former officers and
directors. Initially, four separate shareholder actions were filed between March
and May of 2006 in Federal District Court for the Southern District of New York,
and these were later transferred to the Western District of New York and
consolidated into the above-captioned matter. Plaintiffs in these actions
purport to represent a putative class of shareholders who purchased Company
stock at allegedly artificially inflated levels between January 27, 2005 and May
3, 2006. Among other things, plaintiffs allege that defendants issued materially
false and misleading public statements regarding the Company's financial
condition and operations by failing to disclose negative information relating to
the Company's Brazilian and Korean subsidiaries, internal controls, and problems
with MoistureLoc, thereby inflating the price of Company stock during the class
period. Plaintiffs seek unspecified damages. The cases are currently awaiting
appointment of lead plaintiff and lead plaintiff's counsel in accordance with
the Private Securities Litigation Reform Act. Pursuant to a stipulated schedule
ordered by the Court, the lead plaintiff appointed by the Court must file a
consolidated amended complaint by the earlier of (a) 45 days after the Company
files its Annual Report on Form 10-K for the year ended December 31, 2005, or
(b) 90 days after entry of the Court's order appointing the lead plaintiff,
provided, however, that, at a minimum, the lead plaintiff will have 45 days
after entry of the Court's order appointing the lead plaintiff to file such
consolidated amended complaint.
ERISA-Based Class Actions There is a consolidated ERISA class action, entitled
In re Bausch & Lomb Incorporated ERISA Litigation, Case Nos. 06-cv-6297 (master
file), 06-cv-6315, and 06-cv-6348, pending in the Federal District Court for the
Western District of New York, Rochester Division, against the Company and
certain present and former officers and directors. Initially, three separate
actions were filed between April and May of 2006 in Federal District Court for
the Southern District of New York, and these were later transferred to the
Western District of New York and consolidated into the above-captioned matter.
Plaintiffs in these actions purport to represent a class of participants in our
401(k) Plan for whose individual accounts the plan held an interest in Company
stock between May 25, 2000 and the present. Among other things, plaintiffs
allege that the defendants breached their fiduciary duties to plan participants
by allowing the plan to invest in Company Common stock despite the fact that it
was allegedly artificially inflated due to the failure to disclose negative
information relating to the Company's Brazilian and Korean subsidiaries,
internal controls, and problems with MoistureLoc. Plaintiffs seek unspecified
damages as well as certain declaratory and injunctive relief. On August 28,
2006, the Court entered an order appointing lead plaintiffs and lead plaintiffs'
counsel. Pursuant to a stipulated schedule ordered by the Court, plaintiffs in
the consolidated ERISA action will have until 10 days after a consolidated
amended complaint is filed in the consolidated securities action described
above, to file a consolidated amended complaint.
Shareholder Derivative Actions The shareholder derivative actions, in which a
shareholder seeks to assert the rights of the Company derivatively against
certain present and former officers and directors, fall into two categories: (a)
those asserting allegations relating to accounting issues at the Company's
Brazilian and Korean subsidiaries; and (b) those asserting allegations relating
to the MoistureLoc withdrawal.
There is a consolidated derivative action asserting allegations relating to
accounting issues at the Company's Brazilian and Korean subsidiaries, entitled
In re Bausch & Lomb Incorporated Derivative Litigation, Case Nos. 06-cv-6298
(master file) and 06-cv-6299, pending in Federal District Court for the Western
District of New York, Rochester Division, against certain present and former
officers and directors of the Company, and also naming the Company as nominal
defendant. Initially, two separate derivative actions were filed in April 2006
in Federal District Court for the Southern District of New York, and were later
transferred to the Western District of New York and consolidated. Among other
things, plaintiffs allege that the individual defendants breached their
fiduciary duties to the Company by causing or allowing the Company to issue
materially false and misleading public statements regarding the Company's
financial condition and operations that failed to disclose negative information
about the Company's Brazilian and Korean subsidiaries and internal controls,
thereby inflating the price of Company stock during the relevant time period.
Plaintiffs purport to allege damage to the Company as a result of, among other
things, a decrease in the Company's market capitalization, exposure to liability
in securities fraud actions, and the costs of internal investigations and
financial restatements. Plaintiffs seek unspecified damages as well as certain
declaratory and injunctive relief, including for misappropriation of inside
information for personal benefit by certain of the individual defendants.
Pursuant to a stipulated schedule ordered by the Court, plaintiffs in this
consolidated derivative action will have until 30 days after a consolidated
amended complaint is filed in the consolidated securities action described
above, to file a consolidated amended complaint.
On January 3, 2006, we received a demand letter dated December 28, 2005, from a
law firm not involved in the now consolidated derivative actions described
above, on behalf of a shareholder who also is not involved in the derivative
actions, demanding that the Board of Directors bring claims on behalf of the
Company based on allegations substantially similar to those that were later
alleged in the two derivative actions relating to accounting issues at our
Brazilian and Korean subsidiaries. In response to the demand letter, the Board
of Directors adopted a board resolution establishing an Evaluation Committee
(made up of independent directors) to investigate, review and analyze the facts
and circumstances surrounding the allegations made in the demand letter, but
reserving to the full Board authority and discretion to exercise its business
judgment in respect of the proper disposition of the demand. The Committee has
engaged independent outside counsel to advise it.
There are also two purported derivative actions asserting allegations relating
to the MoistureLoc withdrawal. The first case, entitled Little v. Zarrella, Case
No. 06-cv-6337, was filed in June 2006 in the Federal District Court for the
Southern District of New York and was transferred to the Western District of New
York, Rochester Division, where it is currently pending against certain
directors of the Company, and also naming the Company as nominal defendant. The
second case, entitled Pinchuck v. Zarrella, Case No. 06-6377, was filed in June
2006 in the Supreme Court of the State of New York, County of Monroe, where it
is currently pending against the directors of the Company, and also naming the
Company as nominal defendant. Among other things, plaintiffs in these actions
allege that the individual defendants breached their fiduciary duties to the
Company in connection with the Company's handling of the MoistureLoc withdrawal.
Plaintiffs purport to allege damage to the Company as a result of, among other
things, costs of litigating product liability and personal injury lawsuits,
costs of the product recall, costs of carrying out internal investigations, and
the loss of goodwill and reputation. Plaintiffs seek unspecified damages as well
as certain declaratory and injunctive relief.
Pursuant to a stipulated schedule ordered by the Court, plaintiff in the state-court Pinchuck action served an amended complaint on September 15, 2006 and defendants served a motion to dismiss the amended complaint on November 15, 2006; plaintiff's opposition to the motion was served on January 15, 2007, and defendants' reply is due February 15, 2007. Pursuant to a stipulated schedule ordered by the Court in the federal Little action, plaintiff in that case will have until 60 days after a ruling on a motion to dismiss in the consolidated securities action is entered or, if no such motion is filed, 60 days after defendants' answer to a consolidated amended complaint in the consolidated securities action is filed, to file an amended complaint.
Product Liability Lawsuits As of February 1, 2007, the Company has been served or is aware that it has been named as a defendant in approximately 196 product liability lawsuits pending in various federal and state courts as well as certain other non-U.S. jurisdictions. Of the 196 cases, 117 actions have been filed in U.S. federal courts, 77 cases have been filed in various U.S. state courts and two actions have been filed in non-U.S. jurisdictions. These also include 170 individual actions filed on behalf of individuals who claim they suffered personal injury as a result of using a ReNu solution and 26 putative class actions alleging personal injury as a result of using a ReNu solution and/or violations of one or more state consumer protection statutes. In the personal injury actions, plaintiffs allege liability based on, among other things, negligence, strict product liability, failure to warn and breach of warranty. In the consumer protection actions, plaintiffs seek economic damages, claiming that they were misled to purchase products that were not as safe as advertised. Several lawsuits contain a combination of these allegations. On August 14, 2006, the Judicial Panel on Multidistrict Litigation (JPML) created a coordinated proceeding and transferred an initial set of MoistureLoc product liability lawsuits to the U.S. District Court for the District of South Carolina. The Company has advised the JPML of all federal cases available for transfer and has urged the issuance of conditional transfer orders. As of February 1, 2007, 104 of the 117 federal cases noted above have been transferred to the JPML.
Material Intellectual Property Litigation In October 2005, Rembrandt Vision Technologies, L.P. filed a patent infringement lawsuit against the Company and CIBA Vision Corporation. The action is entitled, Rembrandt Vision Technology, L.P. v. Bausch & Lomb Incorporated and CIBA Vision Corporation, bearing case number 2:05 CV 491, and is pending in the U.S. District Court for the Eastern District of Texas (Marshall Division). Rembrandt asserts that the Company and CIBA have infringed certain of Rembrandt's oxygen permeability and tear-wettability technology that it claims to be protected by a U.S. Patent No. 5,712,327 entitled "Soft Gas Permeable Lens Having Improved Clinical Performance" (the 327 Patent). Rembrandt claims that the Company infringes the 327 Patent by selling soft gas permeable contact lenses that have tear-wettable surfaces in the United States, which would include the Company's PureVision silicone hydrogel lens products. The Company denies, and intends to vigorously defend itself against, Rembrandt's claims. The Court has issued a scheduling order and has set a trial date of November 5, 2007.
Material Tax Litigation As disclosed in Item 8. Financial Statements and Supplementary Data under Note 10 - Provision for Income Taxes of this Annual Report on Form 10-K, on May 12, 2006, the Company received a Notice of Final Partnership Administrative Adjustment from the Internal Revenue Service relating to partnership tax periods ended June 4, 1999 and December 25, 1999, for . . .
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