UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
[ X ] QUARTERLY REPORT PURSUANT
TO SECTION 13 OR 15(d) OF
THE SECURITIES
EXCHANGE ACT OF 1934
For the quarterly period ended
June 30, 1999
OR
[ ] TRANSITION REPORT
PURSUANT TO SECTION 13 OR 15 (d) OF
THE
SECURITIES EXCHANGE ACT OF 1934
For the transition period from
_________ to __________
Commission file number: 005-52501
WARNER CHILCOTT
PUBLIC LIMITED COMPANY
(Exact name of registrant as specified in its charter)
Ireland
(State or other jurisdiction of
incorporation
or organization)
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N/A
(I.R.S. Employer
Identification No.)
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Lincoln House,
Lincoln Place, Dublin 2, Ireland
(Address of principal executive offices)
353 1 662-4962
(Registrant's telephone number, including area code)
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 (or
for such shorter period that the registrant was required to file
such reports), and (2) has been subject to such filing requirements
for the past 90 days.
Yes [ X ] No [
]
Indicate the number of shares outstanding of each of the issuer's
classes of common stock, as of the latest practicable date.
American Depositary Shares,
representing Ordinary Shares, par value $.05 each;
Ordinary Shares, par value $.05 each; 12,366,808 Ordinary Shares
outstanding at June 30, 1999.
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Part I - Financial Information
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Item 1. Financial Statements
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WARNER CHILCOTT PUBLIC LIMITED
COMPANY
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Consolidated Balance Sheets as of
June 30, 1999 and December 31, 1998
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(in thousands of U.S. dollars)
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(UNAUDITED)
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June 30,
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December 31,
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1999
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1998
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ASSETS
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Current Assets:
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Cash and cash equivalents
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$39,243
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$43,133
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Short-term investments
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4,892
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-
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Accounts receivable
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11,768
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18,050
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Inventories
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8,112
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13,099
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Prepaid expense and other assets
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2,750
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7,403
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Total current assets
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66,765
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81,685
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Fixed Assets:
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Equipment, furniture and fixtures
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1,233
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1,076
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Other Assets:
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Intangible assets
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71,569
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74,256
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Total assets
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$139,567
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$157,017
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LIABILITIES
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Current Liabilities:
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Accounts payable
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$3,699
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$8,833
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Accrued liabilities
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4,012
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6,254
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Due to Elan Corporation, plc and subsidiaries
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140
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7,697
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Total current liabilities
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7,851
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22,784
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Other Liabilities:
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Working capital facility
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20,556
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20,393
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Long-term debt
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9,665
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8,897
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Total liabilities
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38,072
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52,074
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SHAREHOLDERS' EQUITY
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Ordinary Shares, par value $.05 per share; 50,000,000
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shares authorized, 12,366,808 shares issued and
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outstanding at June 30, 1999 and December 31, 1998
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618
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618
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Deferred Shares, par value IR£1 per share; 30,000
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shares authorized, 30,000 shares issued and
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outstanding at June 30, 1999 and December 31, 1998
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45
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45
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Additional paid-in capital
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208,991
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208,939
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Accumulated deficit
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(107,387
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(103,578
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Deferred compensation
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(772
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(1,081
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)
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Total shareholders' equity
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101,495
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104,943
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Total liabilities and shareholders' equity
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$139,567
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$157,017
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See accompanying notes to unaudited consolidated
financial statements.
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WARNER CHILCOTT PUBLIC
LIMITED COMPANY
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Consolidated Statements
of Operations for the Three and Six Months Ended June 30, 1999 and
1998
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(in thousands of U.S.
dollars, except per share data)
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(UNAUDITED)
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Three Months Ended June
30,
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Six Months Ended June
30,
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1999
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1998
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1999
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1998
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REVENUES
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Branded product sales
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$7,957
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$4,416
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$16,257
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$7,745
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Generic product sales
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4,271
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8,022
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9,837
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18,560
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Marketing alliances and other revenue
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7,348
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-
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14,530
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-
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Total revenues
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19,576
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12,438
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40,624
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26,305
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OPERATING EXPENSES
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Cost of goods sold
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7,289
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7,819
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15,738
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18,200
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Selling, general and administrative
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11,594
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9,393
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23,705
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18,119
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Depreciation and amortization
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1,420
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1,404
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2,832
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2,808
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Research and development
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788
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721
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1,629
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1,558
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Total operating expenses
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21,091
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19,337
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43,904
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40,685
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OPERATING LOSS BEFORE TAXES
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(1,515)
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(6,899)
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(3,280)
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(14,380)
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OTHER INCOME (EXPENSE)
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Interest income
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508
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679
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1,047
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1,405
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Interest expense
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(805)
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(722)
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(1,576)
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(1,362)
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Total other income (expense)
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(297)
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(43)
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(529)
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43
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NET LOSS BEFORE TAXES
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(1,812)
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(6,942)
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(3,809)
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(14,337)
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Income taxes
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-
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-
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-
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-
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NET LOSS
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$(1,812)
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$(6,942)
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$(3,809)
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$(14,337)
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Net loss per ordinary share
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Basic and Dilutive
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$(0.15)
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$(0.56)
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$(0.31)
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$(1.16)
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Weighted average ordinary shares outstanding
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12,366,808
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12,366,808
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12,366,808
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12,366,808
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See accompanying notes to unaudited consolidated
financial statements.
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WARNER CHILCOTT PUBLIC LIMITED
COMPANY
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Consolidated Statements of Cash
Flows
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(in thousands of U.S. dollars)
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(UNAUDITED)
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Six Months Ended June 30,
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1999
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1998
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CASH FLOWS FROM OPERATING ACTIVITIES:
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Net loss
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$
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(3,809
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$
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(14,337
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Adjustments to reconcile net loss to net cash provided
by
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(used in) operating activities
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Depreciation and amortization
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2,832
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2,808
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Accretion of loan discount
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-
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564
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Stock compensation expense
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309
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309
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Changes in assets and liabilities:
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Decrease in accounts receivable, prepaid expense and
other
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assets
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10,935
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2,430
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Decrease (increase) in inventories
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4,987
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(1,643
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Decrease in accounts payable and accrued liabilities
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(7,376
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(1,144
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)
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(Decrease) increase in due to Elan Corporation, plc and
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subsidiaries
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(7,557
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)
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316
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Net cash provided by (used in) operating activities
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321
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(10,697
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CASH FLOWS FROM INVESTING ACTIVITIES:
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Purchase of tangible fixed assets
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(302
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(75
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Purchase of short-term investment
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(4,892
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-
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Net cash used in investing activities
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(5,194
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(75
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CASH FLOWS FROM FINANCING ACTIVITIES:
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Working capital facility proceeds, net
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163
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5,201
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Senior subordinated notes -- additional notes issued for
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interest payment due April 30, 1999
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768
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-
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Additional paid-in capital -- stock options issued to
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non-employees
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52
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-
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Net cash provided by financing activities
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983
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5,201
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Net decrease in cash and cash equivalents
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(3,890
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)
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(5,571
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)
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Cash and cash equivalents, beginning of period
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43,133
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52,786
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Cash and cash equivalents, end of period
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$
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39,243
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$
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47,215
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See accompanying notes to unaudited consolidated
financial statements.
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WARNER CHILCOTT
PUBLIC LIMITED COMPANY
Notes to the Unaudited Consolidated Financial Statements
June 30, 1999
NOTE 1: BASIS OF
PRESENTATION
The unaudited consolidated financial statements included herein have
been prepared pursuant to the rules and regulations of the
Securities and Exchange Commission for reporting on Form 10-Q.
Certain information and footnote disclosure normally included in the
financial statements prepared in accordance with generally accepted
accounting principles have been condensed or omitted pursuant to
such rules and regulations. The statements should be read in
conjunction with the accounting policies and notes to the
consolidated financial statements included in Warner Chilcott Public
Limited Company's (the "Company" or "Warner Chilcott
") 1998 Annual Report on Form 10-K.
The Company is an Irish public
limited company with operations in Dublin, Ireland and Rockaway, NJ,
USA. The Company's financial statements include the financial
statements for Warner Chilcott Public Limited Company and all of its
subsidiaries and are prepared in U.S. dollars in conformity with
United States generally accepted accounting principles.
In the opinion of management, the
financial statements reflect all adjustments necessary for a fair
statement of the operations for the interim periods presented.
NOTE 2: INVENTORIES
Inventories are valued at the lower of cost or market. Cost is
determined principally on the basis of first-in, first-out or
standards that approximate average cost.
|
June 30, 1999
|
|
December 31, 1998
|
|
(in thousands of U.S.
dollars)
|
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|
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Raw materials
|
$1,079
|
|
$1,897
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Finishing supplies
|
3
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|
3
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Work in process
|
453
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|
932
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Finished goods
|
6,800
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11,597
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8,335
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14,429
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Less: Reserves for obsolesence
|
223
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|
1,330
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Inventories
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$8,112
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|
$13,099
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NOTE 3: SCHERING-PLOUGH AGREEMENT
In July 1998 the Company entered into an agreement under which Warner
Chilcott promotes certain branded pharmaceutical products on behalf
of Schering-Plough. This agreement was amended retroactive to
January 1, 1999 to change the mix of products to be promoted by
Warner Chilcott and the means of calculating royalties earned by
Warner Chilcott based upon the performance of the promoted products.
Revenue from this arrangement is included in the Statement of
Operations under the caption "Marketing alliances and other
revenue".
NOTE 4: ELAN AGREEMENTS
In March 1999 the Company reached a binding agreement with Elan
Corporation, plc under which Elan agreed to acquire Warner
Chilcott's marketing rights to an extended-release nifedipine
product. Under terms of the agreement, as of March 31, 1999, Elan
was obligated to make a non-refundable payment, which was received,
of $3.0 million to Warner Chilcott and such amount was recorded as
revenue in the first quarter of 1999 under the caption "
Marketing alliances and other revenue". In June 1999, the
Company executed the definitive agreement licensing the
extended-release nifedipine product to Elan and received an
additional $4.0 million that was recorded as revenue in the second
quarter of 1999. Under the agreement, additional license fees would
be due to Warner Chilcott upon the completion of certain milestones
including FDA approval of the pending ANDA for the product. Warner
Chilcott would also be entitled to receive royalties based upon
revenues derived from the product.
In March 1999 the Company also
reached a binding agreement with Elan under which Elan re-acquired
the marketing rights to an isosorbide-5-mononitrate product ("
IS5MN-PM") that Elan had been developing for Warner Chilcott.
Under terms of the agreement, as of March 31, 1999, Elan was
obligated to make a payment to Warner Chilcott in an amount equal to
Warner Chilcott's remaining contractual obligation relating to the
development of IS5MN-PM. Such amount had been carried by Warner
Chilcott as an asset in "Prepaid expense and other assets"
and as a liability in "Due to Elan Corporation, plc and
subsidiaries". In concluding this transaction and reducing both
the related asset and liability, Warner Chilcott did not recognize
an income statement effect.
NOTE 5: NET LOSS PER ORDINARY
SHARE
Basic net income per ordinary share has been computed by dividing net
income available to ordinary shareholders by the weighted average
number of ordinary shares outstanding during the period. Diluted net
income per ordinary share is computed by adjusting the weighted
average number of ordinary shares outstanding during the period for
all potentially dilutive ordinary shares outstanding during the
period and adjusting net income for any changes in income or loss
that would result from the conversion of such potential ordinary
shares. Net loss and weighted average shares outstanding used for
computing diluted loss per share were the same as that used for
computing basic loss per share for the three and six months ended
June 30, 1999 and 1998. Stock options and warrants have not been
included in the calculation since the inclusion of such shares would
be antidilutive.
NOTE 6: COMPREHENSIVE INCOME
In June 1997 the Financial Accounting Standards Board (FASB) issued
Statement of Financial Accounting Standards (SFAS) No. 130, "
Reporting Comprehensive Income". Comprehensive income is
defined as the total change in shareholders' equity during the
period other than from transactions with shareholders. For the
Company, comprehensive loss is comprised solely of net loss.
NOTE 7: CONTINGENCIES
The Company is involved in various legal proceedings of a nature
considered normal to its business including patent litigation,
product liability and other matters. In the event of the adverse
outcome of these proceedings, resulting liabilities are either
covered by insurance,
established reserves or, in the opinion of management, would not have
a material adverse effect on the financial condition or results of
operations of the Company.
NOTE 8: UNITED STATES FEDERAL
INCOME TAXES
The Company operates in Ireland
and the United States and is subject to various taxes on income in
both jurisdictions. Warner Chilcott's wholly-owned United States
subsidiary, Warner Chilcott, Inc., is a United States corporation
and, as such, is subject to United States taxation. Ultimate
utilization or availability of net operating losses and certain
deferred tax assets may be limited if a significant change in
ownership occurs, as defined by rules enacted with the United States
Tax Reform Act of 1986. The Company did not accrue any liability for
Federal income taxes in the three or six months ended June 30, 1999
and 1998.
Item 2. Management's
Discussion and Analysis of Financial Condition and Results of
Operations
This report contains
forward-looking statements within the meaning of Section 21E of the
Securities Exchange Act of 1934, as amended, and Section 27A of the
Securities Act of 1933, as amended, and is subject to the safe
harbors created by those sections. These forward-looking statements
are subject to significant risks and uncertainties, including those
identified in the section of this Form 10-Q entitled "Factors
That May Affect Future Operating Results" and in Warner
Chilcott Public Limited Company's (the "Company" or "
Warner Chilcott") 1998 Annual Report on Form 10-K filed with
the Securities and Exchange Commission, which may cause actual
results to differ materially from those discussed in such
forward-looking statements. The forward-looking statements within
this Form 10-Q are identified by words such as "believes",
"anticipates", "expects", "intends",
"may", "will" and other similar expressions.
However, these words are not the exclusive means of identifying such
statements. In addition, any statements that refer to expectations,
projections or other characterizations of future events or
circumstances are forward-looking statements. The Company undertakes
no obligation to release publicly the results of any revisions to
these forward-looking statements that may be made to reflect events
or circumstances occurring subsequent to the filing of this Form
10-Q with the Securities and Exchange Commission. Readers are urged
to review and consider carefully the various disclosures made by the
Company in this report and in the Company's other reports filed with
the Securities and Exchange Commission that attempt to advise
interested parties of the risks and factors that may affect the
Company's business.
Set forth below is the discussion
of the financial condition and results of operations of the Company
for the three and six months ended June 30, 1999 and 1998. This
discussion should be read in conjunction with the consolidated
unaudited financial statements and the related notes, appearing in
Item 1.
Overview
The Company is primarily engaged in the
development, marketing, sale and distribution of prescription
pharmaceutical products in the United States. The Company's current
focus is on branded products targeted for four specialty segments:
women's health care, urology, cardiology and dermatology. All of the
Company's branded products are promoted by the Company's sales force.
The Company currently markets a
portfolio of branded products including: NataFort®, a
prescription prenatal vitamin designed to improve patient compliance
by virtue of its smaller size relative to competing products;
Pyridium® Plus, a urinary tract analgesic and antispasmodic
agent used for irritative bladder conditions; Vectrin®,
an antibiotic used most frequently for the treatment of acne;
Doryx®, a broad spectrum antibiotic; LoCholest®
, a lipid regulator for the reduction of LDL cholesterol levels;
Estrace® vaginal cream, a hormone replacement product;
Ovcon® 35, an oral contraceptive; K-Dur®, a
sustained release potassium supplement; NitroDur®, a
nitroglycerin patch for the treatment of angina; and Lotrisone
®, a corticosteroid / antifungal cream. NataFort®,
Pyridium® Plus, Vectrin®, Doryx® and LoCholest®
are products owned by the Company. Estrace® vaginal cream and
Ovcon® 35 are products owned by Bristol-Myers Squibb and
promoted by the Company under a promotion agreement. K-Dur®,
NitroDur® and Lotrisone® are products owned by
Schering-Plough and promoted by the Company under a promotion
agreement.
The Company plans to add
additional products to its portfolio of branded products through
internal development, co-promotion agreements, in-licensing,
acquisition and development collaborations with other companies.
Revenue from the sale of branded
products accounted for 40.0% and 29.4% of total revenue for the six
months ended June 30, 1999 and 1998, respectively. Revenues from
marketing alliances were first generated in the third quarter of
1998 and accounted for 35.8% of total revenue during the first half
of 1999. Revenue associated with the sale of non-differentiated
generic products in the first half of 1999 accounted for 24.2% of
total revenue, down from 70.5% in the 1998 period.
The foundation for the Company's
future success is its sales and marketing organization. The Company
began to build its sales force in early 1997. During 1998 the
Company's sales force grew from 175 professionals at year-end 1997
to 270 at the end of 1998. Through the second quarter of 1999 the
Company maintained a similar sales force as that at year-end 1998.
The Company's target for its sales force is approximately 295
comprised of 250 representatives in the Company's primary care sales
force, 25 in the dermatology sales force and 20 in sales force
management.
Future revenue growth will be
dependent on the Company increasing the sales of its existing
portfolio of promoted products and adding new products through
acquisition, in-licensing, marketing alliances or self-development.
History
The Company is an Irish public
limited company founded in 1992 as Nalé Laboratories Limited (
"Nalé"). In March 1996 Nalé acquired certain
assets and assumed certain liabilities (the "Acquisition")
of Warner Chilcott Laboratories, a division of the Warner-Lambert
Company (the "Division"). Following the Acquisition, Nal
é changed its name to Warner Chilcott Public Limited Company.
The principal purpose of the
Acquisition was to provide the Company with channels of distribution
in the United States. The Company also gained an established
reputation in the pharmaceutical industry, a portfolio of existing
products, and a functioning organization. The Company's customer
base includes all major national wholesalers and pharmacy chains. In
addition, the Company utilizes the services of an outside
telemarketing organization to cover almost 5,000 independent
pharmacies. The assets and liabilities of the Division acquired in
the Acquisition are now organized in the United States as Warner
Chilcott, Inc., a wholly-owned subsidiary of Warner Chilcott Public
Limited Company.
The Company's revenues are
currently generated in the United States and the U.S. dollar is the
functional currency of the Company. Accordingly, the Company's
exposure to currency fluctuation is limited. Product sourcing from
vendors and research and development agreements are normally
contracted in U.S. dollars. As a company operating in multiple
jurisdictions, the Company will be subject to taxation on its
earnings in the jurisdictions in which it operates. At present, such
jurisdictions include Ireland and the United States.
Results of Operations
Three months ended June 30, 1999 and
1998
In the quarter ended June 30, 1999
the Company generated revenues from three activities: sales of
branded pharmaceutical products, royalties earned under co-marketing
and licensing agreements and sales of non-differentiated generic
products. Total revenue for the quarter increased 57.4% to
$19.6 million from $12.4 million in the prior year. Significant
increases in both branded product sales and marketing alliance
revenue more than offset the decline in sales of generic products.
Sales of branded products
increased by $3.5 million compared with the second quarter of the
prior year. Of the brands promoted during both the current and prior
year, NataFort®, Vectrin® and Doryx® posted gains.
Pyridium® Plus was launched in the first quarter of 1999 and
sales of that product contributed to the increase in comparison with
the prior year. Sales of generic products declined $3.7 million as
the Company continued to reduce its emphasis on generic products in
favor of branded activities.
Marketing alliance and other
revenue totaled $7.3 million in the quarter and included royalties
earned under a co-promotion agreement with Schering-Plough, $4.0
million of fees earned in consideration of Warner Chilcott licensing
its marketing rights to an extended-release nifedipine product to
Elan, and a small amount of royalties earned under a co-promotion
agreement with Apothecon, a unit of Bristol-Myers Squibb. The
Company did not record any revenue from marketing alliances or
license agreements in the second quarter of 1998.
Gross profit on product sales
increased to $4.9 million from $4.6 million in the prior year
despite a reduction in total product sales from $12.4 million to
$12.2 million. The increased gross profit reflects an improvement in
gross margin from 37.1% to 40.4% due to a more favorable mix of
products sold in the 1999 quarter versus the 1998 quarter. In 1999,
higher-margin branded products represented 65.1% of product sales as
compared with 35.5% in the prior year.
Selling, general and
administrative expenses increased by $2.2 million compared with the
prior year. The primary factor driving the increase was the
expansion of the Company's sales force from an average strength of
171 professionals in the year-ago quarter to 268 in the second
quarter of 1999. Also contributing to the increase was a rise in
advertising and promotion costs, mainly due to promotional
activities in support of the recently launched Pyridium® Plus
and increased sampling activity in support of NataFort®.
Research and development costs
for the quarter of $0.8 million were consistent with the first
quarter 1998 reflecting the Company's continuing focus on
development projects with near-term revenue potential and relatively
low funding requirements. These projects include the development of
line extensions for both the Company's own branded products and for
the oral contraceptive Ovcon® 35 under a license agreement with
Bristol-Myers Squibb.
Interest income declined slightly
to $0.5 million from $0.7 million due to the decrease in cash on
hand. Interest expense increased slightly from the second quarter
1998 to $0.8 million from $0.7 million reflecting an increase in the
interest rate associated with the Company's outstanding senior
subordinated notes.
The net result of the factors
outlined above was that the net loss for the quarter decreased to
$1.8 million as compared to a net loss of $6.9 million for the
second quarter of 1998. The increased contribution from sales of the
Company's own branded products, combined with the addition of
substantial revenue from various marketing alliances, more than
offset the increased costs of the Company's expanded sales force and
advertising expenses. The loss per ordinary share for the quarter
decreased to ($0.15) from ($0.56) on an equal number of shares.
Six months ended June
30, 1999 and 1998
Total revenue for the six months
ended June 30, 1999 increased 54.4% to $40.6 million from $26.3
million for the same period in 1998. Significant increases in both
branded product sales and marketing alliance revenue more than
offset the decline in sales of generic products.
Branded product sales in the
six-month period more than doubled, rising to $16.2 million from
$7.7 million in 1998. Of the brands promoted during the current and
prior year periods, NataFort®, Vectrin®, Doryx® and
LoCholest® all posted gains. Pyridium® Plus was launched
in the first quarter of 1999 and sales of that product during the
six-month period contributed to the increase in comparison with the
prior year. Sales of generic products declined 47.0% to $9.8 million
as the Company continued to reduce its emphasis on generic products
in favor of branded activities.
Marketing alliance and other
revenue totaled $14.5 million in the period and included royalties
earned under a co-promotion agreement with Schering-Plough, $7.0
million of fees earned in consideration of Warner Chilcott licensing
its marketing rights to an extended-release nifedipine product to
Elan, royalties earned from Elan under a distribution agreement for
IS5MN, a small amount of royalty revenue earned under a co-promotion
agreement with Apothecon, a unit of Bristol-Myers Squibb, and a
small amount of royalty revenue earned under an agreement with Barr
Laboratories relating to sales of generic minocycline. The Company
did not record any revenue from marketing alliances or license
agreements in the six months ended June 30, 1998.
Gross profit on product sales
increased to $10.3 million from $8.1 million in the prior year
despite a reduction in total product sales from $26.3 million to
$26.1 million. The increased gross profit reflects an improvement in
gross margin from 30.8% to 39.7% due to a more favorable mix of
products sold in the 1999 period versus 1998. In 1999, higher-margin
branded products represented 62.3% of product sales as compared with
29.4% in the prior year.
Selling, general and
administrative expenses increased by $5.6 million compared with the
prior year. The primary factor driving the increase was the
expansion of the Company's sales force from an average strength of
171 professionals in the year-ago period to 263 in 1999. Also
contributing to the increase was a rise in advertising and promotion
costs, mainly due to promotional activities in support of the launch
of Pyridium® Plus in the 1999 period and increased sampling
activity in support of NataFort®. General and administrative
costs increased versus the prior year due to a modest increase in
administrative staff offset somewhat by a reduction in legal fees
related to the extended-release nifedipine product.
Research and development costs of
$1.6 million were consistent with the prior year period. Interest
income decreased $0.4 million to $1.0 million due to a decline in
funds available for investment. Interest expense increased $0.2
million to $1.6 million due to the increased cost of the Company's
senior subordinated debt.
The net loss for the six months
ended June 30, 1999 was $3.8 million compared to $14.3 million for
the prior year period. Revenues from marketing alliances and the
improved gross profit on product sales, offset slightly by the
increased operating costs, were the main factors leading to the
reduced loss. The basic and dilutive loss per ordinary share for the
six months ended June 30, 1999 decreased to ($0.31) per share from
($1.16) per share on the same number of ordinary shares outstanding.
Factors That May
Affect Future Operating Results
Following is a discussion of some of
the risks and historical facts which should be considered when
evaluating the current and future results of the Company. This
discussion is not intended to include all risks and historical facts
that could produce adverse results.
The Company has a history of
operating losses. Operating losses have been posted since the
formation of the Company in 1992. As of June 30, 1999, the Company's
accumulated deficit was $107.4 million. The Company has invested in
the corporate infrastructure and sales organization needed to
support the marketing and product development activities that
management believes necessary for the success of the Company.
However, there can be no assurance that these efforts will be
sufficient and, thus, future profitability is uncertain.
The future capital needs and
additional funding activities of the Company are uncertain. Warner
Chilcott has experienced negative cash flows from operations and has
funded its activities to date from the issuance of equity and debt
securities. The Company has expended, and will continue to be
required to expend, substantial funds for promotional activities for
products, to continue research and development of product
candidates, to in-license and acquire additional products and to
undertake sales and marketing efforts of its current or future
products. Although the Company may seek additional funding through
the public or private capital markets, there can be no assurance
that any such funding will be available to the Company.
Intense competition exists within
the pharmaceutical industry. Many companies, some with greater
financial, marketing and development capabilities than the Company,
are engaged in developing, marketing and selling products that
compete with the products offered by Warner Chilcott. Other products
now in use or under development by others may be more effective or
have fewer side effects than the Company's current or future
products. The industry is characterized by rapid technological
change, and competitors may develop their products more rapidly than
the Company. Competitors may also be able to complete the regulatory
process sooner and, therefore, may begin to market their products in
advance of the Company's products. There can be no assurance that
developments by others will not render any product or technology the
Company produces to be obsolete or otherwise noncompetitive.
The clinical development,
manufacture, marketing and sale of pharmaceutical products is
subject to extensive federal, state and local regulation in the
United States and similar regulation outside the United States. FDA
approval is required before most drug products can be marketed. FDA
filings can be time consuming and expensive without assurance that
the results will be adequate to justify approval. There can be
substantial delays in the process, including the need to provide
additional data. There can be no assurance that approvals for
filings already made by the Company, or to be made in the future,
can be obtained in a timely manner, if at all, or that the
regulatory requirements for any such proposed products can be met.
In addition, new regulations may adversely affect the Company's
operations or competitive position in the future.
The distribution network for
pharmaceutical products has in recent years been subject to
increasing consolidation. As a result, a few large wholesale
distributors control a significant share of the market. In addition,
the number of independent drug stores and small chains has decreased
as retail pharmacy consolidation has occurred. Continued
consolidation of either wholesale distributors or retail pharmacies
may adversely affect the Company's operations.
The Company depends on third
parties for the manufacture of its current and future products.
Currently, the Company does not possess the facilities or resources
needed for these activities. The Company's strategy for development,
commercialization and manufacturing of certain of its
products entails entering into various arrangements with corporate
collaborators, licensors and others. If any of the Company's
corporate collaborators were unable to satisfy their contractual
obligations to the Company, there can be no assurance that the
Company would be able to negotiate similar arrangements with other
third parties.
Many of the principal components
of the Company's products are available only from single source
suppliers. There can be no assurance that the Company will establish
or, if established, maintain good relationships with such suppliers
or that such suppliers will continue to exist or be able to supply
ingredients in conformity with regulatory requirements.
The Company is engaged in the
manufacture and marketing of products that may give rise to the
development of certain legal actions and proceedings. The Company
carries product liability insurance and umbrella liability
insurance. There can be no assurance that this coverage is adequate
to cover potential liability claims or that additional insurance
coverage will be available in the future if the Company manufactures
and markets new products. The Company's financial condition and
results of operations could be materially adversely affected by the
unfavorable outcome of legal actions and proceedings.
Liquidity and Capital
Resources
As of June 30, 1999 the Company had
$44.1 million of cash, cash equivalents and short-term investments
on hand, an increase of $1.0 million as compared with December 31,
1998. The net loss after adding back depreciation and amortization
was $1.0 million compared with $11.5 million for the same period in
the prior year. Generally, the cash used in operations and the
increase in cash and equivalents were funded by a $0.2 million
increase in bank borrowings, a $0.8 million increase in long-term
debt and a $1.0 million decrease in investment in adjusted working
capital (current assets, excluding cash, cash equivalents and
short-term investments, less current liabilities).
The Company's inventory and
accounts receivable balances decreased primarily due to the shift in
mix of products sold to include more branded sales and away from the
more working capital intensive generic product sales. Accounts
receivable at December 31, 1998 included a large amount related to
the Schering-Plough co-promotion agreement. Amounts earned by the
Company under this agreement are paid quarterly in arrears. The
Company's receivable from Schering-Plough at June 30, 1999 decreased
compared with December 31, 1998 consistent with the decline in
revenues earned under the agreement in the first half of 1999.
The reduction in prepaid expenses
and other current assets from December 31, 1998 to June 30, 1999 was
primarily the result of the Company licensing its rights to IS5MN-PM
to Elan during the period. Included in prepaid expenses at December
31, 1998 was $4.5 million that represented the Company's development
commitment to the IS5MN-PM project. A corresponding amount was
included as a liability under the caption "Due to Elan
Corporation, plc and subsidiaries". In connection with the
licensing of the IS5MN-PM rights to Elan, the prepaid amount and the
related liability were eliminated.
Total current liabilities were
substantially reduced between December 31, 1998 and June 30, 1999.
Accounts payable decreased by $5.1 million due to the timing of
certain payments for inventory purchases. Accrued liabilities
decreased by $2.2 million mainly due to the payment during the first
quarter of 1999 of calendar year 1998 incentive compensation
accruals. The amounts due to Elan decreased as payment of amounts
due to Elan, including the remaining development obligation for
IS5MN-PM discussed above, were processed during the period.
On March 30, 1998, the Company
entered into a $30 million working capital credit facility with a
syndicate of banks led by PNC Business Credit to fund a portion of
its investment in inventories and accounts receivable. Credit
availability under the PNC facility is based on the balances of
certain inventory, accounts receivable and other assets of Warner
Chilcott, Inc., the Company's wholly-owned United States operating
subsidiary. As of June 30, 1999, the Company's outstanding balance
under this agreement amounted to $20.6 million and an additional
$5.1 million was available to the Company.
The Company posted a loss for the
six months ended June 30, 1999 and losses may continue throughout
1999 and beyond. In addition, the Company may invest in additional
working capital or make capital expenditures to support its various
business activities. Management believes the combination of the
Company's cash balances and availability under its working capital
credit facility provide Warner Chilcott with access to sufficient
capital to meet its requirements for at least the next two years.
There can be no assurance, however, that such funds will be
sufficient. Beyond such period, and in the absence of the Company
generating cash from operations, the Company would need to raise
additional funds. The Company expects that it would seek additional
funding through public or private equity or debt financings or
through collaborations. To the extent the Company raises additional
capital by issuing equity securities, ownership dilution to existing
shareholders will result and future investors may be granted rights
superior to those of existing shareholders. There can be no
assurance that additional funding will be available on acceptable
terms, or at all.
Inflation
Inflation had no material impact on
Warner Chilcott's operations during the six months ended June 30,
1999.
Year 2000
During 1997 the Company initiated a
plan to identify, assess and remediate "Year 2000" issues.
This plan consists of three phases as follows: Phase I -
identification of all internal business critical systems and
applications, key vendors, and major customers. Although completed
in June 1998, Phase I includes the ongoing assessment of new vendors
and customers as they become associated with the Company's business
activities. Phase II - assessment of Year 2000 compliance for all
systems and activities identified in Phase I. Phase II was completed
by December 31, 1998. Phase III - remediation and/or development of
contingency plans for non-compliant systems and activities. Although
all issues requiring remediation or contingency plans have been
addressed, the Company will continue to review its systems and
contingency plans through the Year 2000 transition.
The Company's primary information
technology systems are used in the finance, administration, billing,
distribution and selling systems operated in the Company's U.S.
operating subsidiary, Warner Chilcott, Inc. Since the Acquisition in
March 1996, the Company has put into place new systems to replace
those systems previously provided by Warner-Lambert Company to the
former Division. As a result, the Company's computer systems and
applications have been recently developed. Year 2000 upgrades of
network software and hardware, and financial software are complete.
All internal business critical systems and applications are also
Year 2000 compliant.
The Company has sent written
inquiries to its key vendors and major customers as to their
progress in identifying and addressing Year 2000 compliance issues.
Those vendors and customers who have responded have reported that
they expect to be Year 2000 compliant well before the critical date.
The Company does not expect the
costs associated with Year 2000 compliance to be material. As of
June 30, 1999, the Company incurred less than $100,000 in the above
mentioned system and application upgrades. These costs were paid
from available funds. The Company does not expect to incur
additional costs of significance and has not deferred information
systems projects in order to address Year 2000 issues.
The Company's most reasonably
likely worst case scenario is an interruption in the supply of
products that the Company markets. Warner Chilcott heavily relies on
five third party vendors to manufacture its portfolio of proprietary
products. In the event that any of these vendors' operations proved
not to be Year 2000 compliant, these vendors may not be able to
supply the Company with a continuous supply of products to sell,
putting the Company's business operations seriously at risk. During
1998 and 1999, the Company has closely monitored these vendors'
efforts to obtain Year 2000 compliance. All five of these vendors
have informed the Company that they are either compliant or will be
compliant before the critical date. In order to ease the possible
impact of an interruption in product manufacture and delivery, the
Company has built up a two-month inventory in accordance with its
Disaster Recovery Plan. The Company believes that this supply would
enable the Company to continue operations while the vendor worked to
resume manufacturing.
The Company's operations also
heavily rely on the ongoing supply of the Schering-Plough products
which the Company promotes, as well as Schering-Plough's continuing
ability to report sales and subsequently compute royalties payable
to Warner Chilcott. Schering-Plough has informed the Company that
they are Year 2000 compliant.
Warner Chilcott utilizes third
party vendors to perform additional functions including, but not
limited to, warehousing, distribution, billing services and market
research. Critical vendors have provided the Company with
written confirmation of their anticipation of Year 2000 compliance.
Based on the Company's assessment
efforts to date, the Company believes that Year 2000 issues will not
be disruptive to its operations, nor have a material adverse effect
on its financial condition or results of operations. The Company's
beliefs and expectations, however, are based on certain assumptions
and expectations that ultimately may prove to be inaccurate. There
can be no assurance that the failure to ensure Year 2000 compliance
by a third party would not have a material adverse effect on the
Company.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
The following discussion about Warner
Chilcott's exposure in market risk of financial instruments contains
forward-looking statements. Actual results may differ materially
from those described.
The Company's holdings of
financial instruments are comprised of U.S. corporate debt, foreign
corporate debt, U.S. and state government debt, foreign
government/agency guaranteed debt, bank deposits and certificates of
deposit, and commercial paper. All such instruments are classified
as securities available for sale. Warner Chilcott does not invest in
portfolio equity securities or commodities or use financial
derivatives for trading purposes. Warner Chilcott's debt security
portfolio represents funds held temporarily pending use in the
Company's business and operations. The Company manages these funds
accordingly. Warner Chilcott seeks reasonable assuredness of the
safety of principal and market liquidity by investing in fixed rate
income securities while at the same time seeking to achieve a
favorable rate of return. Warner Chilcott's market risk exposure
consists principally of exposure to changes in interest rates. The
Company's holdings are also exposed to the risks of changes in the
credit quality of issuers.
Warner Chilcott invests in the shorter-end of the maturity spectrum,
and at June 30, 1999, 100% of such holdings mature in one year
or less.
Part II - Other
Information
Item 1. Legal Proceedings
The Company is involved in litigation
relating to claims arising out of its operations in the normal
course of business, including product liability claims.
On July 1, 1999 the U.S. Court of
Appeals for the Federal Circuit, which has jurisdiction of appeals
in patent cases, affirmed a decision by the U.S. District Court for
the Northern District of Illinois in which the District Court held
invalid Abbott Laboratories' U.S. Patent on anhydrous terazosin
hydrochloride (the " `207 patent"), Abbott Laboratories
v. Geneva Pharmaceuticals, et al., Dkt. Nos. 98-1593, - 1594, -
1595. Although the Company is not a party to that action, it was the
defendant in a separate action in the same District Court, in which
Abbott alleged that the Company had infringed the `207 patent by
filing an application with the Food and Drug Administration ("
F.D.A.") for approval to market anhydrous terazosin chloride.
Abbott Laboratories v. Warner Chilcott. Because that action
was pending, F.D.A. was precluded by law from approving the
Company's application for thirty months. Based on the District
Court's decision in Abbott v. Geneva Pharmaceuticals the
District Court entered summary judgment in favor of the Company in
Abbott v. Warner Chilcott again holding the patent invalid.
The decision by the Court of Appeals affirming the invalidity of the
patent in Abbott v. Geneva thus has the effect of affirming
the invalidity of the patent in Abbott v. Warner Chilcott as
well. Subject to any rights any of the defendants in Abbott v.
Geneva may have under the Hatch-Waxman Act to a 180-day
statutory period of marketing exclusivity, the Court of Appeals'
decision ends the statutory period in which F.D.A. was statutorily
barred from approving the Company's application. Abbott's counsel
have indicated that Abbott intends to ask the Court of Appeals to
reconsider its decision and, if that application is not successful,
Abbott may seek review of the Court of Appeals' decision in the
Supreme Court.
There have been no other
significant developments in the proceedings described in the
Company's 1998 Annual Report on Form 10-K filed with the Securities
and Exchange Commission, and the Company has not become involved in
any additional material proceedings.
Item 4. Submission of Matters to a Vote of Security Holders
(a)
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The Annual General
Meeting of Shareholders of Warner Chilcott, plc was held on June
3, 1999.
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(b)
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All of the
nominees for director were elected by a vote of shares as follows.
Mr. Chefitz and Mr. Pinkerton were re-elected to the board. Mr.
Voydeville is replacing Madame Nicole Bru who retired from the
board by rotation. There were no broker non-votes.
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Name
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For
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Against
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Abstain
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Harold N. Chefitz
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1,821,459
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7,140
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-
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David N. Pinkerton
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1,822,159
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6,440
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-
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Didier Voydeville
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1,823,159
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5,440
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-
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(c)
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The following
matters were brought to vote. There were no broker non-votes.
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i.
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The Financial
Statements for the year ended December 31, 1998 together with the
reports of the directors and auditors thereon were presented to
the shareholders and were approved by a vote of shares as follows:
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For
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Against
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Abstain
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1,823,859
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4,740
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-
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ii.
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The directors were
authorized to fix the remuneration of the auditors by a vote of
shares as follows:
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For
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Against
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Abstain
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1,817,759
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10,840
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-
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iii.
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The Amended
Incentive Share Option Scheme, originally adopted by the Company
on April 3, 1997 was presented to the shareholders and approved by
a vote of shares as follows:
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For
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Against
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Abstain
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1,788,187
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40,412
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-
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iv.
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The ordinary
resolution conferring upon the board of directors the power to
allot shares, grant share subscription rights and rights to
convert loans and other obligations into stock was presented to
the shareholders and approved by a vote of shares as follows:
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For
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Against
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Abstain
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1,794,787
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33,812
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-
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v.
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The special
resolution eliminating pre-emptive rights of existing shareholders
for a five-year period was presented to the shareholders and
approved by a vote of shares as follows:
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For
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Against
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Abstain
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1,798,187
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30,412
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-
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vi.
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The authorization
to transact such other business as may be transacted at an Annual
General Meeting was presented to the shareholders and approved by
a vote of shares as follows:
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For
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Against
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Abstain
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1,814,499
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14,100
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-
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Item 5. Other Information
Pursuant to newly adopted rules of the
Securities and Exchange Commission, any company shareholder who
intends to present a proposal at the Company's Annual General
Meeting of shareholders in 2000 without requesting that the Company
include such proposal in the Company's proxy materials should be
aware that he or she must notify the Company not later than January
25, 2000 of his or her intention to present such proposal.
Otherwise, the Company may exercise discretionary voting with
respect to such shareholder proposal pursuant to authority conferred
on the Company by proxies delivered to the Company in connection
with the meeting.
Item 6. Exhibits and Reports on Form 8-K
a.
Exhibits - The following exhibit is filed with this
document:
Exhibit
No.
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Description
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10.1
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Second Amendment
to Promotion Agreement between Schering Corporation and Warner
Chilcott PLC, dated May 10, 1999
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10.2
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Incentive Share
Option Scheme originally adopted on April 3, 1997, amended on June
3, 1999
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10.3
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Agreement between
Elan Corporation, plc and Warner Chilcott, plc, dated June 24, 1999
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27
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Financial Data
Schedule
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b. Reports on Form 8-K:
No report was filed during the
six months ended June 30, 1999.
Pursuant to the requirements of the Securities Exchange Act of 1934,
this report has been signed below by the following persons on behalf
of the Registrant and in the capacities and on the dates indicated.
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WARNER CHILCOTT
PUBLIC LIMITED COMPANY
(Registrant)
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August 13, 1999
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/s/ Paul S.
Herendeen
Paul S. Herendeen
Executive Vice President & Chief Financial Officer
(Principal Financial Officer)
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August 13, 1999
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/s/ David G.
Kelly
David G. Kelly
Group Vice President, Finance
(Principal Accounting Officer)
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