SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
Quarterly Report Under Section 13 or 15(d) of the
Securities Exchange Act of 1934
FOR THE QUARTER ENDED MARCH 31, 2000
COMMISSION FILE NUMBER 001-6351
ELI LILLY AND COMPANY
(Exact name of Registrant as specified in its charter)
INDIANA
|
35-0470950
|
(State or other jurisdiction of
|
(I.R.S. Employer
|
incorporation or organization)
|
Identification No.)
|
LILLY CORPORATE CENTER, INDIANAPOLIS, INDIANA 46285
(Address of principal executive offices)
Registrant's telephone number, including area code (317)
276-2000
Indicate by check mark whether the Registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act
of 1934 during the preceding 12 months, and (2) has been subject to such
filing requirements for the past 90 days.
The number of shares of common stock outstanding as of April 30, 2000:
Class
|
Number of Shares
Outstanding
|
Common
|
1,129,353,265
|
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
CONSOLIDATED CONDENSED STATEMENTS OF INCOME
(Unaudited)
Eli Lilly and Company and Subsidiaries
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
2000
|
|
|
|
1999
|
|
|
|
|
|
|
(Dollars in
millions except
per-share data)
|
|
Net sales
|
$
|
2,451.1
|
|
|
$
|
2,255.6
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales
|
|
508.7
|
|
|
|
493.5
|
|
|
Research and development
|
|
458.5
|
|
|
|
413.1
|
|
|
Marketing and administrative
|
|
688.3
|
|
|
|
592.9
|
|
|
Asset impairment and other site charges
|
|
|
|
|
|
61.4
|
|
|
Interest expense
|
|
46.8
|
|
|
|
43.9
|
|
|
Other (income) expense - net
|
|
(273.7
|
) |
|
|
107.3
|
|
|
|
|
|
|
|
1,428.6
|
|
|
|
1,712.1
|
|
|
|
|
|
Income from continuing operations before
income taxes
|
|
1,022.5
|
|
|
|
543.5
|
|
|
Income taxes
|
|
177.0
|
|
|
|
92.1
|
|
|
|
|
|
Income from continuing operations
|
|
845.5
|
|
|
|
451.4
|
|
|
Income from discontinued operations, net
of tax
|
|
|
|
|
|
174.3
|
|
|
|
|
|
Net income
|
$
|
845.5
|
|
|
$
|
625.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EARNINGS PER SHARE - BASIC:
|
|
|
|
|
|
|
|
|
Income from continuing
operations
|
$
|
.78
|
|
|
$
|
.41
|
|
|
Income from discontinued operations
|
|
|
|
|
|
.16
|
|
|
|
|
|
Net income
|
$
|
.78
|
|
|
$
|
.57
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EARNINGS PER SHARE - DILUTED:
|
|
|
|
|
|
|
|
|
Income from continuing operations
|
$
|
.77
|
|
|
$
|
.40
|
|
|
Income from discontinued operations
|
|
|
|
|
|
.16
|
|
|
|
|
|
Net income
|
$
|
.77
|
|
|
$
|
.56
|
|
|
|
|
Dividends paid per share
|
$
|
.26
|
|
|
$
|
.23
|
|
|
|
|
See Notes to Consolidated Condensed
Financial Statements.
CONSOLIDATED CONDENSED BALANCE SHEETS
(Unaudited)
Eli Lilly and Company and Subsidiaries
|
|
|
|
|
|
|
|
|
|
|
March 31, 2000
|
|
|
|
December 31, 1999
|
|
|
(Dollars in millions)
|
ASSETS
|
|
|
|
|
|
|
|
CURRENT ASSETS
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
$
|
3,797.8
|
|
|
$
|
3,700.4
|
|
|
Short-term investments
|
|
37.0
|
|
|
|
135.6
|
|
|
Accounts receivable, net of
allowances for doubtful amounts of $77.9 (2000) and $79.9 (1999) |
|
1,388.0
|
|
|
|
1,443.2
|
|
|
Other receivables
|
|
256.7
|
|
|
|
399.6
|
|
|
Inventories
|
|
899.6
|
|
|
|
899.6
|
|
|
Deferred income taxes
|
|
213.0
|
|
|
|
240.3
|
|
|
Prepaid expenses
|
|
360.7
|
|
|
|
236.8
|
|
|
|
|
|
TOTAL CURRENT ASSETS
|
|
6,952.8
|
|
|
|
7,055.5
|
|
|
|
|
|
|
|
|
|
OTHER ASSETS |
|
|
|
|
|
|
|
|
Prepaid retirement
|
|
743.3
|
|
|
|
741.1
|
|
|
Investments
|
|
291.5
|
|
|
|
180.3
|
|
|
Goodwill and other intangibles, net of
allowances for amortization of $108.3 (2000) and $107.6 (1999) |
|
110.0
|
|
|
|
118.6
|
|
|
Sundry
|
|
650.1
|
|
|
|
748.2
|
|
|
|
|
|
|
1,794.9
|
|
|
|
1,788.2
|
|
|
|
|
|
|
|
|
PROPERTY AND EQUIPMENT |
|
|
|
|
|
|
|
|
Land, buildings, equipment, and
construction-in-progress |
|
7,371.8
|
|
|
|
7,347.3
|
|
|
Less allowances for depreciation |
|
3,425.4
|
|
|
|
3,365.8
|
|
|
|
|
|
|
3,946.4
|
|
|
|
3,981.5
|
|
|
$
|
12,694.1
|
|
|
$
|
12,825.2
|
|
|
|
LIABILITIES AND
SHAREHOLDERS' EQUITY
|
|
|
|
|
|
|
|
CURRENT LIABILITIES
|
|
|
|
|
|
|
|
|
Short-term borrowings
|
$
|
51.8
|
|
|
$
|
241.5
|
|
|
Accounts payable
|
|
395.0
|
|
|
|
445.5
|
|
|
Employee compensation
|
|
273.2
|
|
|
|
489.3
|
|
|
Dividends payable
|
|
|
|
|
|
283.0
|
|
|
Income taxes payable
|
|
1,544.3
|
|
|
|
1,445.3
|
|
|
Other liabilities
|
|
962.0
|
|
|
|
1,030.8
|
|
|
|
|
|
TOTAL CURRENT LIABILITIES
|
|
3,226.3
|
|
|
|
3,935.4
|
|
|
|
|
|
|
|
|
|
LONG-TERM DEBT
|
|
2,783.1
|
|
|
|
2,811.9
|
|
DEFERRED INCOME TAXES
|
|
81.7
|
|
|
|
137.0
|
|
RETIREE MEDICAL BENEFIT OBLIGATION
|
|
111.0
|
|
|
|
115.7
|
|
OTHER NONCURRENT LIABILITIES
|
|
833.6
|
|
|
|
812.2
|
|
|
|
|
|
|
|
3,809.4
|
|
|
|
3,876.8
|
|
|
|
|
|
|
|
|
|
|
COMMITMENTS AND CONTINGENCIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SHAREHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
Common stock
|
|
681.3
|
|
|
|
682.0
|
|
|
Retained earnings
|
|
5,717.5
|
|
|
|
4,985.6
|
|
|
Deferred costs-ESOP
|
|
(139.0
|
)
|
|
|
(139.9
|
)
|
|
Accumulated other comprehensive income
|
|
(494.6
|
)
|
|
|
(406.4
|
)
|
|
|
|
|
5,765.2
|
|
|
|
5,121.3
|
|
Less cost of common stock in
treasury |
|
106.8
|
|
|
|
108.3
|
|
|
|
|
|
5,658.4
|
|
|
|
5,013.0
|
|
|
|
|
$
|
12,694.1
|
|
|
$
|
12,825.2
|
|
|
|
See Notes to Consolidated Condensed Financial Statements.
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
Eli Lilly and Company and Subsidiaries
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
2000
|
|
|
|
1999
|
|
|
|
|
(Dollars in millions)
|
CASH FLOWS FROM OPERATING
ACTIVITIES
|
|
|
|
|
|
|
|
Net income
|
$
|
845.5
|
|
|
$
|
625.7
|
|
Adjustments to Reconcile Net Income to
Cash
|
|
|
|
|
|
|
|
Flows from
Operating Activities:
|
|
|
|
|
|
|
|
Changes in operating assets and liabilities
|
|
(91.8
|
) |
|
|
(710.0
|
)
|
Depreciation and amortization
|
|
116.2
|
|
|
|
112.4
|
|
Change in deferred taxes
|
|
(14.4
|
) |
|
|
(2.1
|
)
|
Gain related to sale of Kinetra, net of tax
|
|
(214.4
|
) |
|
|
|
|
Gain related to sale of PCS, net of tax
|
|
|
|
|
|
(174.3
|
)
|
Asset impairment, net of tax
|
|
|
|
|
|
39.9
|
|
Other, net
|
|
(30.9
|
) |
|
|
(.8
|
)
|
|
|
|
|
|
|
|
|
|
|
NET CASH PROVIDED BY (USED IN)
OPERATING ACTIVITIES
|
|
610.2
|
|
|
|
(109.2
|
)
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING
ACTIVITIES
|
|
|
|
|
|
|
|
Net purchases of property and equipment
|
|
(110.0
|
) |
|
|
(84.7
|
)
|
Purchase of investments
|
|
(139.7
|
) |
|
|
(2.9
|
)
|
Proceeds from sale of investments
|
|
452.2
|
|
|
|
104.2
|
|
Other, net
|
|
(22.9
|
) |
|
|
(55.3
|
)
|
Proceeds from sale of PCS
|
|
|
|
|
|
1,600.0
|
|
|
|
|
|
|
|
|
|
|
|
NET CASH PROVIDED BY INVESTING ACTIVITIES
|
|
179.6
|
|
|
|
1,561.3
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING
ACTIVITIES
|
|
|
|
|
|
|
|
Dividends paid
|
|
(282.2
|
) |
|
|
(251.6
|
)
|
Purchase of common stock and other capital
transactions |
|
(241.8
|
) |
|
|
(399.2
|
)
|
Issuances under stock plans
|
|
44.7
|
|
|
|
149.5
|
|
Net change in short-term borrowings
|
|
(188.4
|
) |
|
|
(21.1
|
)
|
Net repayments of long-term debt
|
|
(6.0
|
) |
|
|
(.2
|
)
|
|
|
|
|
|
|
|
|
|
|
NET CASH USED FOR FINANCING ACTIVITIES
|
|
(673.7
|
) |
|
|
(522.6
|
)
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash and
cash equivalents
|
|
(18.7
|
) |
|
|
(20.8
|
)
|
|
|
|
|
|
|
|
|
|
|
NET INCREASE IN CASH AND CASH EQUIVALENTS
|
|
97.4
|
|
|
|
908.7
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at January 1
|
|
3,700.4
|
|
|
|
1,495.7
|
|
|
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS AT MARCH 31
|
$
|
3,797.8
|
|
|
$
|
2,404.4
|
|
|
|
See Notes to Consolidated Condensed Financial Statements.
CONSOLIDATED CONDENSED STATEMENTS OF COMPREHENSIVE INCOME
(Unaudited)
Eli Lilly and Company and Subsidiaries
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31, |
|
|
2000
|
|
|
|
1999
|
|
|
|
|
(Dollars in millions)
|
|
|
|
|
|
|
|
|
Net income
|
$
|
845.5
|
|
|
$ |
625.7
|
|
|
|
|
|
|
|
|
|
Other comprehensive income
(loss)1
|
|
(88.2
|
) |
|
|
(142.6
|
) |
|
|
|
|
|
|
|
|
|
|
Comprehensive income
|
$
|
757.3
|
|
|
$ |
483.1
|
|
|
|
1
|
|
The significant component of other comprehensive income was a
loss of $69.9 million from foreign currency translation adjustments for
the three months ended March 31, 2000, as compared to a loss of $134.2
million for the three months ended March 31, 1999. |
See Notes to Consolidated Condensed Financial Statements.
SEGMENT INFORMATION
The company operates in one significant business segment - pharmaceutical
products. Operations of the animal health business are not material and
share many of the same economic characteristics as pharmaceutical products.
The company's business segments are distinguished by the ultimate end user
of the product: humans or animals. Performance is evaluated based on profit
or loss from operations before income taxes. Income before income taxes for
the animal health business for the first quarters of 2000 and 1999 was
approximately $45 million and $40 million, respectively.
SALES BY PRODUCT CATEGORY
Worldwide sales by product category for the first quarters of 2000 and 1999
were as follows:
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
2000
|
|
|
1999
|
|
|
|
|
|
|
(Dollars in millions)
|
Net sales - to unaffiliated customers
|
|
|
|
|
|
|
|
Neurosciences
|
$
|
1,104.2
|
|
$
|
1,044.7
|
|
|
Endocrinology
|
|
575.2
|
|
|
393.2
|
|
|
Anti-infectives
|
|
233.0
|
|
|
270.5
|
|
|
Cardiovascular
|
|
158.0
|
|
|
150.6
|
|
|
Animal health
|
|
155.4
|
|
|
146.6
|
|
|
Oncology
|
|
141.3
|
|
|
121.2
|
|
|
Gastrointestinal
|
|
67.9
|
|
|
111.5
|
|
|
Other pharmaceuticals
|
|
16.1
|
|
|
17.3
|
|
|
|
|
Net sales
|
$
|
2,451.1
|
|
$
|
2,255.6
|
|
|
|
NOTES TO CONSOLIDATED CONDENSED
FINANCIAL STATEMENTS
BASIS OF PRESENTATION
The accompanying unaudited consolidated condensed financial statements have
been prepared in accordance with the requirements of Form 10-Q and therefore
do not include all information and footnotes necessary for a fair
presentation of financial position, results of operations, and cash flows in
conformity with generally accepted accounting principles. In the opinion of
management, the financial statements reflect all adjustments, all of which
are of a normal recurring nature, that are necessary for a fair statement of
the results of operations for the periods shown. The preparation of
financial statements in conformity with generally accepted accounting
principles requires management to make estimates and assumptions that affect
the reported amounts of assets, liabilities, revenues, expenses, and related
disclosures at the date of the financial statements and during the reporting
period. Actual results could differ from those estimates.
CONTINGENCIES
Barr Laboratories, Inc. (Barr), and Geneva Pharmaceuticals, Inc. (Geneva),
have each submitted an Abbreviated New Drug Application (ANDA) seeking FDA
approval to market generic forms of Prozac before the expiration of the
company's patents. The ANDAs assert that two U.S. patents held by Lilly
covering Prozac are invalid and unenforceable. The company filed suit
against Barr and Geneva in federal court in Indianapolis seeking a ruling
that Barr's challenge to Lilly's patents is without merit. On January 12,
1999, the trial court granted summary judgment in favor of Lilly on two of
the four claims raised by Barr and Geneva against Lilly's patents. That
decision has been appealed, and oral arguments on the appeal were heard on
March 8, 2000. On January 25, 1999, Barr and Geneva dismissed their other
two claims in exchange for a $4 million payment, which Barr and Geneva will
share with a third defendant.
In late 1998, three additional generic pharmaceutical companies, Zenith
Goldline Pharmaceuticals, Inc.; Teva Pharmaceuticals USA; and Cheminor
Drugs, Ltd., together with one of its subsidiaries, filed ANDAs for generic
forms of Prozac, asserting that the later of the two patents (expiring in
December 2003) is invalid and unenforceable. In early 1999, Novex Pharma, a
division of Apotex, Inc., changed its previously-filed ANDA to assert that
both the 2001 and 2003 patents are invalid and unenforceable. Lilly has
filed suits against the four companies in federal court in Indianapolis. In
November 1999, Lilly filed a lawsuit against Cheminor Drugs and Schein
Pharmaceuticals, Inc., based on their ANDA filing for an additional dosage
form. A trial date of October 30, 2000, has now been set for these cases. In
March 2000, another generic company, Alphapharm Pty., Ltd., filed an ANDA
challenging the company's patents. In April 2000, Barr notified the company
that it filed a second ANDA for an additional dosage form. While the company
believes that the claims of all these generic companies are without merit,
there can be no assurance that the company will prevail. An unfavorable
outcome of this litigation could have a material adverse effect on the
company's consolidated financial position, liquidity, and results of
operations.
The company has been named as a defendant in numerous product liability
lawsuits involving primarily two products, diethylstilbestrol (DES) and
Prozac. The company has accrued for its estimated exposure with respect to
all current product liability claims. In addition, the company has accrued
for claims incurred, but not filed, to the extent the company can formulate
a reasonable estimate of their costs. The company's estimates of these
expenses are based primarily on historical claims experience and data
regarding product usage. The company expects the cash amounts related to the
accruals to be paid out over the next several years. The majority of costs
associated with defending and disposing of these suits are covered by
insurance. The company's estimate of insurance recoverables is based on
existing deductibles, coverage limits, and the existing and projected future
level of insolvencies among its insurance carriers.
Under the Comprehensive Environmental Response, Compensation, and Liability
Act, commonly known as Superfund, the company has been designated as one of
several potentially responsible parties with respect to fewer than 10 sites.
Under Superfund, each responsible party may be jointly and severally liable
for the entire amount of the cleanup. The company also continues remediation
of certain of its own sites. The company has accrued for estimated Superfund
cleanup costs, remediation, and certain other environmental matters, taking
into account, as applicable, available information regarding site
conditions, potential
cleanup methods, estimated costs, and the extent to which other parties can be
expected to contribute to payment of those costs. The company has reached a
settlement with its primary liability insurance carrier providing for
coverage for certain environmental liabilities and has instituted litigation
seeking coverage from certain excess carriers.
The environmental liabilities and litigation accruals have been reflected
in the company's consolidated condensed balance sheet at the gross amount of
approximately $160.9 million at March 31, 2000. Estimated insurance
recoverables of approximately $123.1 million at March 31, 2000, have been
reflected as assets in the consolidated balance sheet.
While it is not possible to predict or determine the outcome of the patent,
product liability, antitrust, or other legal actions brought against the
company or the ultimate cost of environmental matters, the company believes
that, except as noted above, the costs associated with all such matters will
not have a material adverse effect on its consolidated financial position or
liquidity but could possibly be material to the consolidated results of
operations in any one accounting period.
EARNINGS PER SHARE
All per share amounts, unless otherwise noted in the footnotes, are
presented on a diluted basis, that is, based on weighted average number of
outstanding common shares and the effect of all potentially dilutive common
shares (primarily unexercised stock options).
ACCOUNTING CHANGES
In June 1998, Statement of Financial Accounting Standards (SFAS) No. 133,
"Accounting for Derivative Instruments and Hedging Activities,"
was issued. Statement 133 was amended in June 1999 and is now required to be
adopted in years beginning after June 15, 2000. The statement permits early
adoption as of the beginning of any fiscal quarter after its issuance. The
company will adopt Statement 133 on January 1, 2001. The statement will
require the company to recognize all derivatives on the balance sheet at
fair value. Derivatives that are not hedges must be adjusted to fair value
through income. If the derivative is a hedge, depending on the nature of the
hedge, changes in the fair value of derivatives will either be offset
against the change in fair value of the hedged assets, liabilities, or firm
commitments through earnings or recognized in other comprehensive income
until the hedged item is recognized in earnings. Hedge ineffectiveness (the
amount by which the change in the value of a hedge does not exactly offset
the change in the value of the hedged item) will be immediately recognized
in earnings. The company has determined that adopting Statement 133 and
applying it to the company's interest rate derivatives will not have a
material effect on the earnings and financial position of the company based
on the interest rate derivatives owned by the company at December 31, 1999.
The effect of applying Statement 133 to the company's foreign currency
derivative instruments cannot be determined at this time as the company is
still evaluating what changes, if any, should be made to its foreign
currency hedging program in light of the requirements of Statement 133.
DISCONTINUED OPERATIONS
In November 1998, the company signed a definitive agreement for Rite Aid
Corporation to acquire PCS, the company's health-care-management subsidiary,
for $1.60 billion in cash. The transaction closed on January 22, 1999, and
generated a gain of $174.3 million ($.16 per share), net of $8.7 million tax
benefit, in the first quarter of 1999. The results of operations from PCS
prior to the close of the sale were not material, and have been classified
as discontinued operations in the consolidated condensed statements of
income.
UNUSUAL ITEMS
During the first quarter of 2000, the company sold its interest in Kinetra
LLC, a joint venture between the company and EDS, to Healtheon/WebMD
Corporation (Healtheon) in exchange for shares of Healtheon common stock. A
gain of $214.4 million was recognized on the combined effect of the
transaction and the subsequent sale of the majority of those shares of
Healtheon stock. The gain is included in other income (expense) in the
consolidated condensed statement of income.
During the fourth quarter of 1999, the company realized an estimated $91
million of sales as a result of year-2000-related wholesaler buying that
normally would have been realized during the first quarter of 2000.
During the first quarter of 1999, the company recognized a pretax charge of
$150.0 million, which resulted from a contribution made to Eli Lilly and
Company Foundation, the non-profit foundation through which the company
makes charitable contributions. The charge for the contribution has been
included in other income (expense) in the consolidated condensed statement
of income.
During the first quarter of 1999, the company also recognized a pretax
asset impairment charge of $61.4 million to adjust the carrying value of
certain manufacturing assets to fair value. The major portion of the charge
related to the decommissioning of a building previously used for antibiotic
manufacturing, which resulted from the consolidation of certain
manufacturing processes. The company planned to continue ownership of the
vacated building although no planned future uses had been identified. The
fair value of the facility was estimated based upon anticipated future cash
flows, discounted at a rate commensurate with the risk involved.
Item 2. |
|
Management's Discussion and Analysis of Financial Condition
and Results of Operations |
OPERATING RESULTS FROM CONTINUING OPERATIONS
Income from continuing operations was $845.5 million, or $.77 per share,
for the first quarter of 2000, compared with $451.4 million, or $.40 per
share, for the first quarter of 1999. Comparisons between the first quarter
of 2000 and the first quarter of 1999 are made difficult by the impact of
several unusual items that are reflected in the company's operating results
for both periods. Excluding these unusual items, which are discussed further
below, income from continuing operations for the first quarters of 2000 and
1999 would have been $692.3 million, or $.63 per share, and $588.8 million,
or $.53 per share, respectively. This represents increases in earnings and
earnings per share of 18 percent and 19 percent, respectively. Income from
continuing operations was favorably affected by increased sales, improved
gross margins, and increased other income, offset somewhat by higher
marketing and administrative and research and development expenses as a
percent of sales. Earnings per share for the first quarter of 2000 benefited
from a lower number of shares outstanding resulting from the company's share
repurchase programs.
As noted above, several unusual items are reflected in the company's
operating results for the first quarters of 2000 and 1999. These
transactions are summarized as follows (see "Unusual Items" in the
Notes to Consolidated Condensed Financial Statements for additional
information):
|
|
The company recognized a gain of $214.4 million on the sale of
its interest in Kinetra LLC to Healtheon and the subsequent sale of
Healtheon stock, which increased earnings per share by approximately $.20
in the first quarter of 2000. |
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|
The company realized an estimated $91 million of sales as a
result of year-2000-related wholesaler buying during the fourth quarter of
1999 that normally would have been realized in the first quarter of 2000,
which decreased earnings per share by approximately $.06 in the first
quarter of 2000. |
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|
The company recognized a pretax charge of $150.0 million as
the result of a contribution to Eli Lilly and Company Foundation, which
decreased earnings per share by approximately $.09 in the first quarter of
1999. |
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The company recognized a pretax charge of $61.4 million
associated with the impairment of certain manufacturing assets, which
decreased earnings per share by approximately $.04 in the first quarter of
1999. |
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The company recognized a gain on the disposal of PCS of $174.3
million, net of $8.7 million tax benefit, which increased earnings per
share by approximately $.16, net of tax, in the first quarter of 1999. |
The company's reported sales for the first quarter of 2000 increased 9
percent, to $2.45 billion, compared with the first quarter of 1999. Sales
growth was led by diabetes care revenues, Zyprexa, and Evista. Revenue
growth was partially offset by lower sales of Axid and anti-infectives.
Sales in the U.S. increased 11 percent, to $1.51 billion, for the first
quarter of 2000, compared with the first quarter of 1999. International
sales increased 5 percent, to $938.3 million, for the first quarter of 2000,
compared with the first quarter of 1999. Worldwide sales reflected volume
growth of 10 percent, partially offset by an unfavorable exchange rate
impact of 1 percent, while selling prices remained flat.
Worldwide sales of Prozac in the first quarter of 2000 were $596.2 million,
an increase of 1 percent, compared with the first quarter of 1999. Prozac
sales in the U.S. increased 12 percent, to $508.0 million, due to abnormally
low wholesaler buying during the first quarter of 1999. Sales outside the
U.S. decreased 35 percent, to $88.2 million, primarily due to the entrance
of generic competition in the U.K. in the first quarter of 2000. The company
expects slight declines in worldwide Prozac sales in 2000 compared with 1999
primarily due to increased generic competition outside the U.S. Actual sales
levels will depend on the effectiveness of the company's marketing efforts
in offsetting increased competition, the rate of growth of the
antidepressant market, and the stocking patterns of wholesalers, retailers,
and consumers.
In the first quarter of 2000, Zyprexa had worldwide sales of $458.1
million, an increase of 14 percent, compared with the first quarter of 1999.
U.S. sales increased 1 percent, to $299.8 million, and sales outside the
U.S. increased 53 percent, to $158.3 million. Sales comparisons in the U.S.
were negatively affected by wholesaler stocking in the first quarter of
1999. In the first quarter of 2000, Zyprexa was approved by the U.S. Food
and Drug Administration (FDA) for the treatment of acute mania associated
with bipolar disorder. The company expects continued strong sales growth for
Zyprexa in 2000 due, in part, to the new indication.
Worldwide Gemzar sales were $136.0 million in the first quarter of 2000, an
increase of 19 percent, compared with the first quarter of 1999. Sales in
the U.S. increased by $7.7 million, or 11 percent, while sales outside the
U.S. increased by $13.9 million, or 32 percent.
ReoPro sales for the first quarter of 2000 were $110.3 million, which
reflected an increase of 9 percent, compared with the first quarter of 1999.
Growth for ReoPro was principally driven by sales outside the U.S. Due to
increased competition in the U.S., the company now anticipates modest
worldwide sales growth for ReoPro in 2000.
Diabetes care revenues, composed primarily of Humulin, Humalog, and Actos,
increased 53 percent, to $392.0 million, compared with the first quarter of
1999. Diabetes care revenues increased 71 percent in the U.S., to $226.3
million, and increased 33 percent outside the U.S., to $165.7 million.
Worldwide Humulin sales of $273.7 million increased 35 percent. Worldwide
Humalog sales of $72.1 million increased 70 percent. In March 2000, the
company launched Humalog Mix75/25 Pen in the U.S. for the treatment of
diabetes. The company anticipates moderate growth in sales of diabetes care
products, excluding Actos, in 2000. The company received service revenues of
$42.5 million in the first quarter of 2000 relating to sales of Actos, a
portion of which was attributed to the withdrawal of a competitive product
from the market. Actos, an oral agent for the treatment of type 2 diabetes,
was introduced to the U.S. diabetes market in the third quarter of 1999.
Actos is manufactured and sold in the U.S. by Takeda Chemical Industries,
Ltd., and is copromoted by the company. The company anticipates very strong
growth in Actos revenues in 2000.
For the first quarter of 2000, worldwide sales of anti-infectives decreased
14 percent, to $233.0 million, as a result of continuing competitive
pressures. U.S. and international anti-infectives sales declined 11 percent
and 16 percent, respectively. Cefaclor and Lorabid accounted for the
majority of the decline in anti-infective sales.
Evista sales were $100.5 million in the first quarter of 2000, an increase
of 84 percent over the first quarter of 1999 due, in part, to the FDA
approval for the treatment of postmenopausal osteoporosis, which was
received in September of 1999. While most of the sales dollar growth for
Evista occurred in the U.S., international Evista sales reflected strong
percentage growth.
Worldwide sales of Axid decreased 39 percent, to $67.9 million, in the
first quarter of 2000, compared with the first quarter of 1999, due to
continued competitive pressures.
For the first quarter of 2000, gross margins were 79.2 percent, compared
with 78.1 percent for the first quarter of 1999. The improved gross margin
was primarily the result of favorable product mix, and to a lesser extent,
increased volume, and improvements in productivity.
Operating expenses (the aggregate of research and development and marketing
and administrative expenses) increased 14 percent for the first quarter of
2000. Investment in research and development increased 11 percent, to $458.5
million, for the first quarter. Marketing and administrative expenses
increased 16 percent from the first quarter of 1999 due, in part, to
increased spending to support worldwide product launches.
Net other income for the first quarter of 2000 increased $17.6 million, to
$60.3 million, excluding the first quarter 2000 gain on the sale of Kinetra
LLC and the first quarter 1999 charge from funding Eli Lilly and Company
Foundation. The increase was primarily due to an increase in interest
income.
For the first quarter of 2000, the effective tax rate was 17.3 percent
compared with 17.0 percent for the first quarter of 1999. Excluding the
impact of the unusual items discussed previously, the effective tax rate
would have been 22.0 percent for both periods.
FINANCIAL CONDITION
As of March 31, 2000, cash, cash equivalents and short-term investments
totaled $3.83 billion as compared with $3.84 billion at December 31, 1999.
Cash flow from operations of $610.2 million was offset by dividends paid of
$282.2 million, shares repurchased of $241.8 million, a decrease in debt of
$218.5 million, and capital expenditures of $114.0 million. Total debt at
March 31, 2000, was $2.83 billion, a decrease of $218.5 million from
December 31, 1999, primarily due to the repayment of $200 million of euro
bonds in February 2000. In March 2000, the company announced a $3.0 billion
share repurchase program, following successful completion of a $1.5 billion
share repurchase in 1999.
The company believes that cash generated from operations in 2000, along
with available cash and cash equivalents, will be sufficient to fund
essentially all of the 2000 operating needs, including debt service, capital
expenditures, share repurchases, and dividends.
EURO CONVERSION
On January 1, 1999, 11 European nations adopted a common currency, the
euro, and formed the European Economic and Monetary Union (EMU). For a
three-year transition period, both the euro and individual participants'
currencies will remain in circulation. After July 1, 2002, at the latest,
the euro will be the sole legal tender for EMU countries. The adoption of
the euro affects a multitude of financial systems and business applications
as the commerce of these nations will be transacted in the euro and the
existing national currency.
The company has created the capability to transact in both the euro and the
legacy currency and will continue to address euro-related issues and their
impact on information systems, currency exchange rate risk, taxation,
contracts, competition, and pricing. Action plans currently being
implemented are expected to result in compliance with all laws and
regulations; however, there can be no certainty that such plans will be
successfully implemented or that external factors will not have an adverse
effect on the company's operations. Any costs of compliance associated with
the adoption of the euro will be expensed as incurred and the company does
not expect these costs to be material to its results of operations,
financial condition, or liquidity.
PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Under the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995, the company cautions investors that any forward-looking
statements or projections made by the company, including those made in this
document, are based on management's expectations at the time they are made,
but they
are subject to risks and uncertainties that may cause actual results to differ
materially from those projected. Economic, competitive, governmental,
technological and other factors that may affect the company's operations and
prospects are discussed in Exhibit 99 to this Form 10-Q filing.
PART II. OTHER INFORMATION
Item 1. |
|
Legal Proceedings |
PROZAC PATENT LITIGATION
In March 1996 the company was informed by Barr Laboratories, Inc.
("Barr"), a generic pharmaceutical manufacturer, that it had
submitted an abbreviated new drug application ("ANDA") to the U.S.
FDA seeking to market a generic form of Prozac in the United States several
years before the expiration of the company's patents. Barr has alleged that
the company's U.S. patents covering Prozac are invalid and unenforceable.
The compound patent expires in February 2001 and a patent for the method of
use of the compound expires in December 2003. These patents are material to
the company.
On April 11, 1996, the company filed suit in the United States District
Court for the Southern District of Indiana seeking a ruling that Barr's
challenge to the two patents is without merit. In 1997, Geneva
Pharmaceuticals, Inc. ("Geneva"), another generic manufacturer,
submitted a similar ANDA and, like Barr, asserted that the company's U.S.
Prozac patents are invalid and unenforceable. On June 23, 1997, the company
sued Geneva in the same court seeking a similar ruling as in the Barr suit.
The two suits were consolidated. On January 12, 1999, the trial court judge
for the Southern District of Indiana granted partial summary judgment in the
company's favor, dismissing the claims of Barr and Geneva based on the
patent doctrines of "best mode" and "double patenting."
On January 25, 1999, Barr and Geneva agreed to abandon their remaining two
claims (based on the patent doctrines of "anticipation" and
"inequitable conduct") in exchange for a payment of $4 million to
be shared among Barr, Geneva, and a third defendant, Apotex, Inc. Barr,
Geneva, and Apotex appealed the trial court's January 12, 1999 rulings to
the Court of Appeals for the Federal Circuit. The Court of Appeals held oral
arguments on the appeal on March 8, 2000, and a decision is pending.
In late 1998, three additional generic manufacturers, Zenith Goldline
Pharmaceuticals, Inc., Teva Pharmaceuticals USA, and Cheminor Drugs, Ltd.
together with one of its subsidiaries filed ANDAs for generic forms of
Prozac, asserting that the December 2003 patent is invalid and
unenforceable. Also, in January 1999, Novex Pharma, a division of Apotex,
Inc. filed an ANDA asserting that both the 2001 and 2003 patents are invalid
and unenforceable. The company filed lawsuits in the United States District
Court of the Southern District of Indiana seeking rulings that the four
companies' challenges to the patent(s) are without merit. In November 1999,
the company filed a lawsuit in federal court in Indiana against Cheminor
Drugs and Schein Pharmaceuticals, Inc., based on their ANDA filing for an
additional dosage form. A trial date of October 30, 2000, has been set for
the cases involving Zenith, Teva, Cheminor, and Schein. In March 2000, the
company received notice that another generic manufacturer, Alphapharm Pty.,
Ltd., has filed an ANDA for one dosage form, asserting that both the 2001
and 2003 patents are invalid and unenforceable. In April 2000, Barr notified
the company that it filed a second ANDA for an additional dosage form.
The company believes that the claims of all of these generic manufacturers
are without merit and that the company should be successful in this
litigation. However, it is not possible to predict or determine the outcome
of this litigation and accordingly there can be no assurance that the
company will prevail. An unfavorable outcome could have a material adverse
effect on the company's consolidated financial position, liquidity, and
results of operations.
PRICING LITIGATION
Reference is made to the discussion entitled "Pricing Litigation"
in Part I, Item 3 of the company's 1999 annual report on Form 10-K. The
following developments have occurred in that litigation since the time of
filing of the 1999 Form 10-K: The recent settlement with approximately 3,800
of the Federal Individual Action retailer plaintiffs is now final. In
addition, an agreement in principle has been reached to settle the
Mississippi class action case brought by retailers. Finally, with respect to
the consumer class actions pending in various state courts, the pending case
in Alabama has been dismissed by the courts, and the
company has reached an agreement to settle all of the other remaining state
court cases (New Mexico, North Dakota, South Dakota, Tennessee, and West
Virginia), subject in each case to court approval
.
Item 6. |
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Exhibits and Reports on Form 8-K |
(a) |
Exhibits. |
The following documents are filed
as exhibits to this Report: |
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EXHIBIT 10. |
1998 Lilly Stock Plan, as amended |
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EXHIBIT 11. |
Statement re: Computation of Earnings Per
Share |
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EXHIBIT 12. |
Statement re: Computation of Ratio of Earnings
from Continuing Operations to Fixed Charges |
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EXHIBIT 27. |
Financial Data Schedule |
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EXHIBIT 99. |
Cautionary Statement Under Private Securities
Litigation Reform Act of 1995 - "Safe Harbor" for
Forward-Looking Disclosures |
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(b) |
Reports on Form 8-K. |
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The company filed no reports on Form 8-K during the first
quarter of 2000. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this Report to be signed on its behalf by the
undersigned thereunto duly authorized.
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ELI LILLY AND COMPANY |
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(Registrant) |
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Date |
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May 12, 2000 |
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/s/ Alecia A. DeCoudreaux |
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Alecia A. DeCoudreaux |
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Secretary and Deputy General Counsel |
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Date |
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May 12, 2000 |
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/s/ Arnold C. Hanish |
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Arnold C. Hanish |
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Director, Corporate Accounting and |
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Chief Accounting Officer |
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INDEX TO EXHIBITS
The following documents are filed as a part of this Report:
Exhibit |
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10. |
1998 Lilly Stock Plan, as amended*
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11. |
Statement re: Computation of Earnings Per |
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Share
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12. |
Statement re: Computation of Ratio of Earnings |
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from Continuing Operations to Fixed Charges |
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27. |
Financial Data Schedule (EDGAR filing only) |
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99. |
Cautionary Statement Under Private Securities Litigation
Reform Act of 1995 - "Safe Harbor" for Forward-Looking
Disclosures |
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*
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Incorporated by reference from Exhibit A to the Company's
Proxy Statement dated March 3, 2000. |