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FORM 10-Q
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2001
Commission File Number 1-09623
IVAX CORPORATION
FLORIDA 16-1003559
- -------------------------------- -------------------
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
4400 BISCAYNE BOULEVARD, MIAMI, FLORIDA 33137
------------------------------------------------------------------
(Address of principal executive offices) (Zip Code)
(305) 575-6000
----------------------------------------------------
(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.
200,627,525 SHARES OF COMMON STOCK, $.10 PAR VALUE, OUTSTANDING AS OF JULY 31,
2001.
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IVAX CORPORATION
INDEX
PAGE NO.
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PART I - FINANCIAL INFORMATION
Item 1 - Financial Statements
Consolidated Balance Sheets as of June 30, 2001
and December 31, 2000 2
Consolidated Statements of Operations
for the three months and six months ended June 30, 2001 and 2000 3
Consolidated Statements of Cash Flows
for the six months ended June 30, 2001 and 2000 5
Notes to Consolidated Financial Statements 7
Item 2 - Management's Discussion and Analysis of Financial Condition and
Results of Operations 17
Item 3 - Quantitative and Qualitative Disclosures about Market Risk 25
PART II - OTHER INFORMATION
Item 2 - Changes in Securities and Use of Proceeds 28
Item 4 - Submission of Matters to a Vote of Security Holders 28
Item 6 - Exhibits and Reports on Form 8-K 28
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PART I - FINANCIAL INFORMATION
ITEM 1 - FINANCIAL STATEMENTS
IVAX CORPORATION AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(In thousands, except per share data)
JUNE 30, DECEMBER 31,
2001 2000
----------- -----------
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 921,097 $ 251,528
Accounts receivable, net of allowances for doubtful
accounts of $18,523 in 2001 and $19,703 in 2000 197,109 155,685
Inventories 201,396 178,910
Other current assets 84,421 72,991
----------- -----------
Total current assets 1,404,023 659,114
Property, plant and equipment, net 282,168 250,852
Intangible assets, net 246,962 117,171
Other assets 77,198 41,049
----------- -----------
Total assets $ 2,010,351 $ 1,068,186
=========== ===========
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Loans payable $ 24,209 $ 1,877
Current portion of long-term debt 973 934
Accounts payable 53,787 49,951
Accrued income taxes payable 14,956 11,854
Accrued expenses and other current liabilities 164,739 156,008
----------- -----------
Total current liabilities 258,664 220,624
Long-term debt, net of current portion 978,408 253,755
Other long-term liabilities 31,591 23,472
Minority interest 14,583 1,712
Put options -- 84,503
Shareholders' equity:
Common stock, $.10 par value, authorized 437,500 shares,
issued and outstanding 200,374 in 2001 and 198,547 in 2000 20,037 19,855
Capital in excess of par value 437,112 315,039
Put options 7,785 --
Retained earnings 331,201 203,206
Accumulated other comprehensive loss (69,030) (53,980)
----------- -----------
Total shareholders' equity 727,105 484,120
----------- -----------
Total liabilities and shareholders' equity $ 2,010,351 $ 1,068,186
=========== ===========
THE ACCOMPANYING NOTES TO CONSOLIDATED FINANCIAL STATEMENTS ARE AN INTEGRAL
PART OF THESE BALANCE SHEETS.
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IVAX CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
THREE MONTHS SIX MONTHS
PERIOD ENDED JUNE 30, ---------------------------- ----------------------------
(In thousands, except per share data) 2001 2000 2001 2000
--------- --------- --------- ---------
Net revenues $ 301,782 $ 184,827 $ 561,714 $ 368,085
Cost of sales 143,339 95,207 267,063 190,380
--------- --------- --------- ---------
Gross profit 158,443 89,620 294,651 177,705
--------- --------- --------- ---------
Operating expenses:
Selling 30,103 20,637 57,605 38,616
General and administrative 28,906 18,640 52,627 42,815
Research and development 20,020 17,153 38,903 32,609
Amortization of intangible assets 4,229 1,786 7,823 3,755
Reversal of restructuring reserve (220) (3,142) (221) (3,144)
--------- --------- --------- ---------
Total operating expenses 83,038 55,074 156,737 114,651
--------- --------- --------- ---------
Income from operations 75,405 34,546 137,914 63,054
Other income (expense):
Interest income 9,933 3,635 13,741 4,689
Interest expense (10,460) (5,203) (14,819) (7,245)
Other income, net 9,182 886 10,932 5,708
Gain on partial sale of IVAX Diagnostics, Inc. -- -- 10,278 --
--------- --------- --------- ---------
Total other income (expense), net 8,655 (682) 20,132 3,152
--------- --------- --------- ---------
Income from continuing operations before
income taxes and minority interest 84,060 33,864 158,046 66,206
Provision for income taxes 16,211 1,182 29,966 6,622
--------- --------- --------- ---------
Income from continuing operations before
minority interest 67,849 32,682 128,080 59,584
Minority interest 14 (202) (85) (438)
--------- --------- --------- ---------
Income from continuing operations 67,863 32,480 127,995 59,146
Extraordinary item - loss on extinguishment
of debt, net of taxes -- (2,254) -- (2,254)
Cumulative effect of a change in accounting
principle, net of tax benefit of $2,773 in 2000 -- -- -- (6,471)
--------- --------- --------- ---------
Net income $ 67,863 $ 30,226 $ 127,995 $ 50,421
========= ========= ========= =========
(Continued)
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IVAX CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Continuation)
THREE MONTHS SIX MONTHS
PERIOD ENDED JUNE 30, ------------------------------- -------------------------------
(In thousands, except per share data) 2001 2000 2001 2000
----------- ----------- ----------- -----------
BASIC EARNINGS PER COMMON SHARE:
Continuing operations $ 0.34 $ 0.17 $ 0.64 $ 0.30
Extraordinary item -- (0.01) -- (0.01)
Cumulative effect of a change in accounting
principle -- -- -- (0.03)
----------- ----------- ----------- -----------
Net income $ 0.34 $ 0.16 $ 0.64 $ 0.26
=========== =========== =========== ===========
DILUTED EARNINGS PER COMMON SHARE:
Continuing operations $ 0.33 $ 0.16 $ 0.62 $ 0.29
Extraordinary item -- (0.01) -- (0.01)
Cumulative effect of a change in accounting
principle -- -- -- (0.03)
----------- ----------- ----------- -----------
Net income $ 0.33 $ 0.15 $ 0.62 $ 0.25
=========== =========== =========== ===========
WEIGHTED AVERAGE NUMBER OF COMMON
SHARES OUTSTANDING:
Basic 199,876 193,668 199,567 193,873
=========== =========== =========== ===========
Diluted 207,605 203,321 206,979 202,761
=========== =========== =========== ===========
THE ACCOMPANYING NOTES TO CONSOLIDATED FINANCIAL STATEMENTS ARE AN
INTEGRAL PART OF THESE STATEMENTS.
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IVAX CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
SIX MONTHS ENDED JUNE 30, 2001 2000
(In thousands, except per share data) --------- ---------
Cash flows from operating activities:
Net income $ 127,995 $ 50,421
Adjustments to reconcile net income to net cash
flows from operating activities:
Reversal of restructuring reserve established in prior years (221) (3,144)
Depreciation and amortization 22,688 14,904
Deferred tax provision (17,683) (2,452)
Tax effect of stock option exercises 7,751 --
Compensation expense related to partial sale of IVAX Diagnostics 1,041 --
Provision for doubtful accounts 1,033 550
Provision for inventory obsolescence 10,472 3,259
Minority interest 85 438
Equity in earnings of affiliates (619) (377)
Loss on extinguishment of debt -- 2,254
Gain on partial sale of IVAX Diagnostics (10,278) --
Gain on sale of product rights (7,347) (1,813)
Gains on disposal of assets, net (3,495) (841)
Cumulative effect of a change in accounting principle -- 6,471
Changes in operating assets and liabilities:
Accounts receivable (29,665) (3,827)
Inventories (12,906) (28,607)
Other current assets (6,474) 6,496
Other assets 3,482 1,504
Accounts payable, accrued expenses, and other
current liabilities 7,313 (985)
Other long-term liabilities (153) (2,117)
--------- ---------
Net cash flows from operating activities 93,019 42,134
--------- ---------
Cash flows from investing activities:
Proceeds from sale of product rights 3,097 1,813
Capital expenditures (24,071) (19,269)
Proceeds from sales of assets 22,627 29
Proceeds from partial sale of IVAX Diagnostics 22,285 --
Acquisitions of patents, trademarks, licenses and other
intangibles (10,907) (1,476)
Acquisitions of businesses, net of cash acquired (79,809) (5,444)
Investment in affiliated companies (17,913) 913
--------- ---------
Net cash flows from investing activities (84,691) (23,434)
--------- ---------
Cash flows from financing activities:
Borrowings on long-term debt and loans payable 723,785 244,957
Payments on long-term debt and loans payable (17,413) (52,129)
Exercise of stock options and employee stock purchases 11,320 23,481
Repurchases of common stock net of put option premium (58,577) --
--------- ---------
Net cash flows from financing activities 659,115 216,309
--------- ---------
Effect of exchange rate changes on cash and cash equivalents 2,126 (6,714)
--------- ---------
Net increase in cash and cash equivalents 669,569 228,295
Cash and cash equivalents at the beginning of the year 251,528 41,408
--------- ---------
Cash and cash equivalents at the end of the period $ 921,097 $ 269,703
========= =========
(Continued)
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IVAX CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(Continuation)
SIX MONTHS ENDED JUNE 30, 2001 2000
(In thousands, except per share data) --------- --------
Supplemental disclosures:
Interest paid $ 9,135 $ 3,176
========= ========
Income tax payments $ 34,100 $ 8,390
========= ========
Supplemental schedule of non-cash investing and financing activities:
Information related to acquisitions which were accounted for under
the purchase method of accounting is summarized as follows:
Fair value of assets acquired $ 83,886 13,839
Liabilities assumed (56,088) (11,478)
--------- --------
27,798 2,361
Reduction of minority interest -- 5,324
--------- --------
Net assets acquired 27,798 7,685
--------- ========
Purchase price:
Cash, net of cash acquired 79,754 5,444
Acquisition costs 55 --
Fair market value of stock and options issued 77,056 55,000
--------- --------
Total 156,865 60,444
--------- --------
Goodwill $ 129,067 $ 52,759
========= ========
THE ACCOMPANYING NOTES TO CONSOLIDATED FINANCIAL STATEMENTS ARE AN
INTEGRAL PART OF THESE STATEMENTS.
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IVAX CORPORATION AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
(In thousands, except per share data)
(1) GENERAL:
The accompanying unaudited interim consolidated financial statements
have been prepared pursuant to the rules and regulations of the Securities and
Exchange Commission for reporting on Form 10-Q and, therefore, do not include
all information normally included in audited financial statements. However, in
the opinion of management, all adjustments (consisting of only normal recurring
adjustments) necessary to present fairly the results of operations, financial
position and cash flows have been made. The results of operations and cash flows
for the six months ended June 30, 2001, are not necessarily indicative of the
results of operations and cash flows which may be reported for the remainder of
2001. The interim consolidated financial statements should be read in
conjunction with the consolidated financial statements and the notes to
consolidated financial statements included in IVAX' Annual Report on Form 10-K
for the year ended December 31, 2000.
Certain prior period amounts presented in the consolidated financial
statements have been reclassified to conform to the current period's
presentation.
(2) INVENTORIES:
Inventories consist of the following:
JUNE 30, DECEMBER 31,
2001 2000
-------- --------
Raw materials $ 78,377 $ 72,991
Work-in-process 32,259 27,683
Finished goods 90,760 78,236
-------- --------
Total inventories $201,396 $178,910
======== ========
(3) EARNINGS PER SHARE:
On April 20, 2001, IVAX' Board of Directors approved a 5-for-4 stock
split effective May 18, 2001, in the form of a stock dividend for shareholders
of record on May 1, 2001, and a proportional increase in the number of
authorized shares. All share and per share amounts have been retroactively
restated for the split, except where otherwise indicated. A reconciliation of
the denominator of the basic and diluted earnings per share computation for
income from continuing operations is as follows:
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PERIOD ENDED JUNE 30, THREE MONTHS SIX MONTHS
-------------------- --------------------
2001 2000 2001 2000
------- ------- ------- -------
Basic weighted average number of shares outstanding 199,876 193,668 199,567 193,873
Effect of dilutive securities - stock options and
warrants 7,729 9,653 7,412 8,888
------- ------- ------- -------
Diluted weighted average number of shares
outstanding 207,605 203,321 206,979 202,761
======= ======= ======= =======
Not included in the calculation of diluted earnings
per share because their impact is antidilutive:
Stock options outstanding 250 -- 346 --
Convertible debt 26,514 8,412 26,514 8,412
Put options 281 -- 281 --
(4) REVENUES:
Net revenues are comprised of gross revenues less provisions for
expected customer returns, inventory credits, discounts, promotional allowances,
volume rebates, chargebacks and other allowances. The reserve balances related
to these provisions are included in "Accounts receivable, net of allowances for
doubtful accounts" and "Accrued expenses and other current liabilities" in the
accompanying consolidated balance sheets in the amounts of $62,684 and $68,314
respectively, at June 30, 2001, and $51,080 and $63,448, respectively, at
December 31, 2000.
(5) PARTIAL SALE OF IVAX DIAGNOSTICS, INC.:
On March 14, 2001, IVAX' wholly-owned subsidiary, IVAX Diagnostics,
Inc., was merged with b2bstores.com, a non-operating company with a significant
amount of cash, approximately $22,285, resulting in IVAX owning approximately
70% of the newly merged public company. IVAX received 20,000 shares of
b2bstores.com common stock in exchange for all of the outstanding shares of IVAX
Diagnostics, Inc. and b2bstores.com's name was changed to IVAX Diagnostics, Inc.
For accounting purposes, this transaction is treated as a partial sale of IVAX
Diagnostics, Inc. in exchange for cash of b2bstores.com. IVAX elected income
statement recognition as its accounting policy for sales of subsidiary stock and
recorded a gain of $10,278. Deferred taxes have not been recorded related to the
gain as it represents an outside basis difference and IVAX expects it can
recover its investment in IVAX Diagnostics, Inc. tax-free. Also recorded was
$1,041 of nondeductible compensation expense from outstanding options under the
IVAX Diagnostics, Inc. 1999 Stock Option Plan converting to a fair value plan as
a result of the merger. IVAX Diagnostics, Inc. is engaged in the development,
manufacture and marketing of diagnostic test kits, reagents and instruments.
(6) ACQUISITIONS:
On February 9, 2001, IVAX indirectly acquired Laboratorios Fustery,
S.A. de C.V. ("Fustery"), a corporation organized under the laws of Mexico, by
purchasing the outstanding securities of Fustery's parent, Maancirkel Holding
B.V. ("Maancirkel"), a corporation organized under the laws of The Netherlands,
from Morcob CVA, an entity organized under the laws of Belgium pursuant to a
stock purchase agreement entered into among the parties on October 11, 2000.
During the first quarter of 2001, IVAX acquired Maancirkel for 1,656 shares of
IVAX' common stock, valued at $57,000, and $57,210 in cash, net of cash
acquired. During the second quarter of 2001, in accordance with the stock
purchase agreement, IVAX made an additional payment of $16,309 in lieu of
additional shares, representing
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contingent consideration based on the market value of IVAX' common stock. The
preliminary fair value of net assets acquired was $20,212 resulting in goodwill
of $93,998 being recorded. The operating results of Fustery are included in the
consolidated financial statements subsequent to the February 9, 2001,
acquisition date.
On February 26, 2001, IVAX acquired the assets of a research
organization located in the United States for 609 shares of IVAX' common stock,
valued at $18,000, $4,650 in cash, net of cash acquired, and other costs of $28.
The fair value of net assets acquired was $7,085 resulting in goodwill of
$15,593 being recorded. The operating results of this company are included in
the consolidated financial statements subsequent to the February 26, 2001,
acquisition date.
On March 13, 2001, IVAX acquired Netpharma Scandinavia AB
("Netpharma"), a Swedish pharmaceutical company, for 624 shares of IVAX' common
stock, valued at $18,365, other costs of $20 and received cash of $1,000 in
excess of cash paid. In addition, additional shares of IVAX' common stock,
valued at $2,052, will be issued contingent on achievement of earnout targets
for each of the next two years. If the earnout targets are achieved, the number
of additional shares issued will be based on the exchange rate in effect on the
payment dates and the average price of IVAX' common stock just prior to April
30, 2002 and 2003. The preliminary fair value of net assets acquired was $464,
resulting in goodwill of $16,921 being recorded. The operating results of
Netpharma are included in the consolidated financial statements subsequent to
the March 13, 2001, acquisition date.
On April 3, 2001, IVAX acquired the remaining 70% of Indiana Protein
Technologies, Inc. ("Indiana Protein") that it did not already own. Indiana
Protein was previously accounted for as an investment under the equity method of
accounting. This additional interest was acquired for $4,121 in cash, net of
cash acquired, and other costs of $7, of which $2,500 is subject to an earnout
period of 5 years. This acquisition resulted in an increase in net assets of $37
and goodwill of $4,091 being recorded. The operating results of Indiana Protein
are included in the consolidated financial statements subsequent to the April 3,
2001, acquisition date.
Pro-forma information for the above acquisitions as if the purchases
occurred on January 1 of each year are presented below.
PERIOD ENDED JUNE 30, THREE MONTHS SIX MONTHS
---------------------- ----------------------
2001 2000 2001 2000
-------- -------- -------- --------
Revenues $301,801 $218,391 $588,428 $436,254
Net income 67,990 33,170 128,680 57,432
Diluted weighted average shares 207,605 206,211 207,785 205,651
Diluted earnings per share $ 0.33 $ 0.16 $ 0.62 $ 0.28
These pro-forma results of operations are not necessarily indicative of
results that might have been achieved if the acquisitions had actually occurred
on January 1 of the periods presented.
During the first quarter of 2001, IVAX received $1,673 representing a
reduction of purchase price and goodwill of Laboratorios Elmor, S.A. that was
acquired in June 2000. In addition, IVAX paid $137 of other costs, representing
an increase to the purchase price and goodwill of Wakefield Pharmaceuticals,
Inc. that was acquired in September 2000.
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(7) DEBT:
On May 4, 2001, IVAX sold $725,000 of its 4.5% Convertible Senior
Subordinated Notes due 2008 to UBS Warburg LLC (the "Initial Purchaser"). The
Initial Purchaser then sold the 4.5% Notes to Qualified Institutional Buyers
pursuant to Rule 144A of the Securities Act, to institutional "accredited
investors" (as defined in Rule 501 under the Securities Act) in compliance with
Regulation D under the Securities Act and to non-U.S. persons outside the United
States in compliance with Regulation S. IVAX received net proceeds of
approximately $706,150 therefrom. The 4.5% Notes were issued without
registration under the Securities Act and may not be offered or sold in the
United States absent registration or an applicable exemption from the
registration requirements. The 4.5% Notes are convertible at any time prior to
maturity, unless previously redeemed, into 24.96875 shares of IVAX' common stock
per $1 of principal amount of the 4.5% Notes. This ratio results in a conversion
price of approximately $40.05 per share. The 4.5% Notes are redeemable by IVAX
on or after May 29, 2004. The net proceeds from the sale of the 4.5% Notes are
expected to be used primarily to fund the acquisition of businesses and
products, to fund the research, development, testing and commercialization of
IVAX' pharmaceutical products and for general working capital purposes.
(8) INCOME TAXES:
The provision for income taxes from continuing operations consists of
the following:
PERIOD ENDED JUNE 30, THREE MONTHS SIX MONTHS
---------------------- ----------------------
2001 2000 2001 2000
-------- ------- -------- -------
Current:
Domestic $ 29,562 $ -- $ 40,706 $ 493
Foreign 3,217 4,397 6,943 8,581
Deferred (16,568) (3,215) (17,683) (2,452)
-------- ------- -------- -------
Total $ 16,211 $ 1,182 $ 29,966 $ 6,622
======== ======= ======== =======
The domestic current provision for the six months ended June 30, 2001,
was favorably impacted by $13,333 from utilization of previously reserved net
operating loss and tax credit carryforwards and the non-taxable gain on the
partial sale of IVAX Diagnostics, Inc. offset by a $7,600 tax provision
associated with a U.S. taxable gain on the intercompany assignment of a
contract, which was eliminated for financial reporting purposes. Payment of the
current tax liability for the year ended December 31, 2001, for domestic and
foreign operations will be reduced by $5,617 and $2,134, respectively,
representing the incremental impact of compensation expense deductions
associated with non-qualified stock option exercises during the six months ended
June 30, 2001. These amounts were credited to "Capital in excess of par value".
During the second quarter of 2001, $11,216 of the valuation allowance
previously recorded against the domestic net deferred tax asset was reversed due
to management's expectation of increased domestic taxable income in future years
partially offset by $7,390 tax effect of prior years' stock option exercises,
which was credited to "Capital in excess of par value". In addition, during the
second quarter of 2001, domestic deferred tax assets of $13,362 were recognized
relating to originating temporary differences and to reversal, through the
effective rate calculation, of the valuation allowance previously recorded
against the domestic net deferred tax asset based on management's expectation of
increased domestic taxable income in the current year. As of June 30, 2001, a
domestic net deferred tax asset of $66,541 and an aggregate foreign net deferred
tax asset, in jurisdictions with positive net deferred tax assets, of $8,079 are
included in "Other current assets" and "Other assets" in the accompanying
consolidated balance sheet. The domestic net deferred tax asset was
approximately 19% reserved as of June 30, 2001. Realization of the net deferred
tax assets is dependent upon generating sufficient future domestic and foreign
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taxable income. Although realization is not assured, management believes it is
more likely than not that the net deferred tax assets will be realized.
(9) COMPREHENSIVE INCOME:
The components of IVAX' comprehensive income are as follows:
PERIOD ENDED JUNE 30, THREE MONTHS SIX MONTHS
----------------------- ------------------------
2001 2000 2001 2000
-------- -------- --------- --------
Net income $ 67,863 $ 30,226 $ 127,995 $ 50,421
Unrealized gains (losses) on marketable
securities and derivative contracts,
net of taxes 106 (95) 2 184
Foreign currency translation adjustments (299) (17,782) (15,052) (24,163)
-------- -------- --------- --------
Comprehensive income $ 67,670 $ 12,349 $ 112,945 $ 26,442
======== ======== ========= ========
(10) SHAREHOLDERS' EQUITY:
On April 20, 2001, IVAX' Board of Directors approved a 5-for-4 stock
split effective May 18, 2001, in the form of a stock dividend. All weighted
average shares, outstanding shares, per share earnings and price and stock plan
data contained in the accompanying financial statements have been retroactively
adjusted to give effect to the stock split. To reflect the split, common stock
was increased and capital in excess of par value was decreased by $3,993.
During the first six months of 2001, IVAX issued a free-standing put
option for 625 shares, bearing a strike price of $29.80 and collected a premium
of $153. In addition, free-standing put options for 1,581 shares of IVAX common
stock expired unexercised. One put option for 281 shares was exercised by the
holder at a strike price of $27.68. As a result, IVAX elected the physical
settlement method and paid $7,785 in exchange for the underlying shares. Two put
options for 906 shares were exercised by the holder at strike prices ranging
from $27.68 to $29.80. IVAX elected the net share settlement method and issued
62 shares of IVAX' common stock in settlement of the obligation.
(11) BUSINESS SEGMENT INFORMATION:
IVAX is a multinational company with subsidiaries that operate in the
pharmaceutical business and are engaged in the research, development,
manufacture, marketing and sale of pharmaceutical products. Pharmaceutical
products include prescription drugs and over-the-counter products. IVAX reviews
financial information, allocates resources and manages its business by major
operating subsidiary. However, IVAX' pharmaceutical subsidiaries utilize similar
production processes, and sell similar types of products to similar types of
customers under similar regulatory environments using similar methods of
distribution. IVAX also expects these subsidiaries to have similar long-term
financial performance. Since these pharmaceutical subsidiaries meet the
aggregation criteria under paragraph 17 of Statement of Financial Accounting
Standards No. 131, DISCLOSURES ABOUT SEGMENTS OF AN ENTERPRISE AND RELATED
INFORMATION, the pharmaceutical operating subsidiaries are aggregated into one
reportable segment, pharmaceutical, and all other subsidiaries are reported in
Corporate and Other.
To provide additional information, IVAX has disaggregated its
pharmaceutical segment results into the geographic regions in which the
subsidiaries are located. The North America region contains IVAX' subsidiaries
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in the United States and Canada. The Europe region contains subsidiaries located
in Europe. Latin America consists of subsidiaries in South America and Mexico.
Corporate and Other includes the diagnostic subsidiaries, animal health
subsidiary and subsidiaries located in other geographic regions as well as
corporate activities and elimination of intercompany transactions.
The information provided is based on internal reports and was developed
and utilized by management for the sole purpose of tracking trends and changes
in the results of the regions. The information, including the allocations of
expense and overhead, was calculated based on a management approach and may not
reflect the actual economic costs, contributions or results of operations of the
regions as stand alone businesses. If a different basis of presentation or
allocation were utilized, the relative contributions of the regions might differ
but the relative trends would, in management's view, likely not be materially
impacted.
Other revenues included in "Net revenues" in the accompanying
consolidated statements of operations consist of license fees, royalties and
product development fees, received primarily from two companies.
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REVENUES BY REGION
PERIOD ENDED JUNE 30, THREE MONTHS SIX MONTHS
2001 2000 2001 2000
----------- ----------- ----------- -------
North America
External sales $ 162,246 $ 74,505 $ 300,989 $ 142,238
Intersegment sales 77 101 463 301
Other revenues 147 5,161 268 20,007
----------- ----------- ----------- -----------
Net revenues - North America 162,470 79,767 301,720 162,546
----------- ----------- ----------- -----------
Europe
External sales 75,910 66,284 146,198 143,017
Intersegment sales 13,459 8,325 21,200 15,601
Other revenues 13,684 17,593 28,889 25,141
----------- ----------- ----------- -----------
Net revenues - Europe 103,053 92,202 196,287 183,759
----------- ----------- ----------- -----------
Latin America
External sales 38,661 10,529 65,170 18,291
Other revenues 306 336 535 810
----------- ----------- ----------- -----------
Net revenues - Latin America 38,967 10,865 65,705 19,101
----------- ----------- ----------- -----------
Corporate & Other
External sales 9,360 10,422 17,731 18,568
Intersegment sales (13,536) (8,426) (21,663) (15,902)
Other revenues 1,468 (3) 1,934 13
----------- ----------- ----------- -----------
Net revenues - Corporate & Other (2,708) 1,993 (1,998) 2,679
----------- ----------- ----------- -----------
Consolidated net revenues $ 301,782 $ 184,827 $ 561,714 $ 368,085
=========== =========== =========== ===========
PROFITS BY REGION
PERIOD ENDED JUNE 30, THREE MONTHS SIX MONTHS
2001 2000 2001 2000
----------- ----------- ----------- -------
INCOME FROM CONTINUING OPERATIONS
BEFORE MINORITY INTEREST:
North America $ 62,543 $ 37,136 $ 97,629 $ 53,102
Europe (10,382) 8,510 (10,306) 7,855
Latin America 1,783 562 3,088 858
Corporate & Other 13,905 (13,526) 37,669 (2,231)
------------ ----------- ----------- -----------
Income from continuing operations
before minority interest 67,849 32,682 128,080 59,584
------------ ----------- ----------- -----------
NET INCOME:
Minority interest 14 (202) (85) (438)
Extraordinary item -- (2,254) -- (2,254)
Cumulative effect of a change in accounting principle -- -- -- (6,471)
----------- ----------- ----------- -----------
Net income $ 67,863 $ 30,226 $ 127,995 $ 50,421
=========== =========== =========== ===========
JUNE 30,
-------------------------
LONG-LIVED ASSETS: 2001 2000
----------- -----------
North America $ 70,267 $ 53,016
Europe 210,956 233,786
Latin America 175,720 58,988
Corporate & Other 111,572 (2,754)
----------- -----------
Total $ 568,515 $ 343,036
=========== ===========
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(12) RECENTLY ISSUED ACCOUNTING STANDARDS:
Effective January 1, 2001, IVAX adopted SFAS No. 133, which establishes
accounting and reporting standards for derivative instruments, including certain
derivative instruments embedded in other contracts and for hedging activities.
All derivatives, whether designated in hedging relationships or not, are
required to be recorded on the balance sheet at fair value. If the derivative is
designated as a fair value hedge, the changes in the fair value of the
derivative and of the hedged item attributable to the hedged risk are recognized
in earnings. If the derivative is designated as a cash flow hedge, the effective
portions of changes in the fair value of the derivative are recorded in
Accumulated Other Comprehensive Loss ("OCL") and are recognized in the income
statement when the hedged item affects earnings. Ineffective portions of changes
in the fair value of cash flow hedges are recognized in earnings.
Certain forecasted transactions are exposed to foreign currency risk.
The principal currency hedged is the Irish punt against the British pound.
Forward options used to hedge a portion of forecasted international expenses for
up to one year in the future are designated as cash flow hedging instruments.
The adoption of SFAS 133 on January 1, 2001, resulted in an increase to OCL of
$1,613, net of tax of $179. The increase to OCL is mostly attributable to
unrealized gains on cash flow hedges. The net derivative gains included in OCL
as of January 1, 2001, will be reclassified into earnings during the twelve
months ended December 31, 2001.
During the first quarter of 2001, IVAX adopted EITF Issue No. 00-19,
ACCOUNTING FOR DERIVATIVE FINANCIAL INSTRUMENTS INDEXED TO, AND POTENTIALLY
SETTLED IN, A COMPANY'S OWN STOCK, which addresses the classification and
accounting treatment of equity derivative contracts (such as IVAX' put options)
as equity instruments (either temporary or permanent) or assets and liabilities.
As a result, put options were reclassified from temporary equity to permanent
equity. As of June 30, 2001, IVAX had outstanding a freestanding put option for
281 shares of IVAX' common stock that was issued in connection with the share
repurchase program. The put option bore a strike price of $27.68 and expired in
July 2001.
During the first quarter of 2001, IVAX adopted Issue #3 of EITF Issue
No. 00-22, ACCOUNTING FOR POINTS AND CERTAIN OTHER TIME OR VOLUME BASED SALES
INCENTIVE OFFERS AND OFFERS FOR FREE PRODUCTS OR SERVICES TO BE DELIVERED IN THE
FUTURE. Final consensus was reached on the recognition, measurement and income
statement classification of cash rebates or refunds that are time and volume
based. Final consensus has not been reached on four other items under
consideration. EITF 00-22 requires that cash rebates or refunds redeemable if
the customer completes a specified cumulative level of revenue transactions or
remains a customer for a specified time period should be recognized as a
reduction of revenue based on a systematic and rational allocation of the cost
of honoring the rebate or refund earned and claimed to each of the underlying
revenue transactions that result in progress toward earning the rebate or
refund. The effective date of adoption is fiscal quarters ending after February
15, 2001. The impact of adoption was not significant.
Effective July 1, 2001, IVAX adopted SFAS 141, BUSINESS COMBINATIONS,
which addresses the financial accounting and reporting for business
combinations. It supersedes APB Opinion No. 16, BUSINESS COMBINATIONS, and SFAS
38, ACCOUNTING FOR PRE-ACQUISITION CONTINGENCIES OF PURCHASED ENTERPRISES. All
business combinations under the scope of this statement must be accounted for
using the purchase method of accounting. This statement applies to all business
combinations initiated after June 30, 2001. Management believes that adoption of
SFAS 141 will not have a material impact on the company's financial condition or
statement of operations.
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SFAS 142, GOODWILL AND OTHER INTANGIBLE ASSETS, addresses financial
accounting and reporting for acquired goodwill and other intangible assets and
supersedes APB Opinion No. 17, INTANGIBLE ASSETS. It addresses accounting for
intangible assets that are acquired individually or with a group of other assets
(but not those acquired in a business combination) upon acquisition. It also
addresses accounting for goodwill and other intangible assets after they have
been initially recognized in the financial statements. Intangible assets that
have indefinite lives and goodwill will no longer be amortized, but rather they
must be tested at least annually for impairment using fair values. Intangible
assets that have finite useful lives will be amortized over their useful lives.
The statement is effective in fiscal years beginning after December 15, 2001;
except that goodwill and intangible assets acquired after June 30, 2001, will be
subject immediately to the non-amortization and amortization provisions of this
statement. Beginning in 2002, IVAX will reverse the entire balance of negative
goodwill recorded in the balance sheet as of January 1, 2002, of $4,200, through
a cumulative effect of a change in accounting principle; thereby increasing net
income by this amount for the year. In addition, amortization of goodwill
acquired prior to June 30, 2001 will cease. This will increase net income by
approximately $2,700 per quarter, or $10,800 per year. However, management is
unable to estimate the extent of impairment, if any, of intangible assets with
indefinite lives and goodwill, that may need to be recorded in 2002 or future
years.
(13) LEGAL PROCEEDINGS:
With respect to the case styled AMERICAN BIOSCIENCE, INC. V. DONNA E.
SHALALA, ET AL., previously reported in IVAX' Annual Report on Form 10-K for the
year ended December 31, 2000, on March 30, 2001, the appellate court vacated the
district court's decision and remanded the case based on FDA's failure to file
an administrative record in the court below. On April 6, 2001, FDA filed its
administrative record and American BioScience, Inc. ("ABI") renewed its motion
for a temporary restraining order or preliminary injunction. On April 19, 2001,
the district court again denied ABI's motion. ABI has appealed this ruling, and
on May 4, 2001, the appellate court ordered that the appeal be expedited.
With respect to the case styled BRISTOL MYERS SQUIBB COMPANY V. ZENITH
GOLDLINE PHARMACEUTICALS, INC., ET AL., previously reported in IVAX' Annual
Report on Form 10-K for the year ended December 31, 2000, on April 20, 2001, the
appellate court affirmed the district court's grant of summary judgment of
invalidity with respect to all but two of the asserted claims of Bristol's
patents and remanded the remaining claims to the district court for further
proceedings. The Company will now pursue its counterclaims against Bristol.
(14) RESTRUCTURING COSTS:
The components of restructuring costs, spending and other activity, as
well as the remaining reserve balances at June 30, 2001, which are included in
"Accrued expenses and other current liabilities" in the accompanying
consolidated balance sheets, are as follows:
EMPLOYEE TOTAL
TERMINATION PLANT RESTRUCTURING
BENEFITS CLOSURES RESERVES
------------ -------- -------------
Balance at January 1, 2001 $ 110 $ 619 $ 729
Reversals (91) (130) (221)
Cash payments (73) (90) (163)
Non-cash activities 62 (20) 42
------------ ------------- -------------
Balance at June 30, 2001 $ 8 $ 379 $ 387
============ ============== =============
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(15) SUBSEQUENT EVENTS:
On July 5, 2001, IVAX acquired 99.6% of the outstanding shares and
American Depositary Shares of Laboratorio Chile S.A. ("Lab Chile"), a
pharmaceutical company located in Chile, in a tender offer for cash. The tender
offer was initiated on May 31, 2001, and expired on June 29, 2001. The total
cost of the tender offer was $393,807. The total purchase price, including
acquisition costs less cash acquired of $13,368, was $382,835. The fair value of
net assets acquired, based on a balance sheet as of July 5, 2001, was $115,191,
resulting in an amount of cost in excess of fair value of net assets of
$281,012. The excess cost has been allocated on a preliminary basis of $81,000
to identifiable intangible assets with a weighted average 10 year life and
$200,012 to goodwill. This preliminary allocation is consistent with amounts
used in IVAX' analysis of the consideration paid for Lab Chile and is subject to
change based on receipt of final appraised values of assets acquired and
liabilities assumed, which is expected to be received within the allocation
period. Lab Chile was acquired as part of IVAX' strategy of expanding in growing
pharmaceutical markets.
In addition, on July 31, 2001, IVAX commenced a second tender offer,
expiring August 29, 2001, for the remaining outstanding shares of Lab Chile.
Through August 10, 2001, IVAX issued 6 European-style put options on
1,400 shares of IVAX common stock bearing strike prices ranging from $31.00 to
$31.50 and collected total premiums of $3,642. These put options will mature
between November 2001 and March 2002. In the event that the put options are
exercised, IVAX may elect to settle using one of three methods: physical
settlement by payment in exchange for IVAX shares, net share settlement or net
cash settlement.
Through August 9, 2001, IVAX repurchased 275 shares of its common stock
at a total cost, including commissions, of $8,568.
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ITEM 2 - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
The following discussion and analysis should be read in conjunction
with the consolidated financial statements, the related notes to consolidated
financial statements and management's discussion and analysis of financial
condition and results of operations included in IVAX' Annual Report on Form 10-K
for the year ended December 31, 2000, and the unaudited interim consolidated
financial statements and the related notes to unaudited interim consolidated
financial statements included in Item 1 of this Quarterly Report on Form 10-Q.
All per share amounts related to June 30, 2000, have been retroactively restated
to reflect the 5-for-4 stock split paid May 18, 2001, to shareholders of record
on May 1, 2001. Certain prior period amounts presented have been reclassified to
conform to the current period's presentation.
RESULTS OF OPERATIONS
SIX MONTHS ENDED JUNE 30, 2001 COMPARED TO THE SIX MONTHS ENDED JUNE 30, 2000
Net income was $128 million, or $.62 per share (diluted), for the six
months ended June 30, 2001, compared to $50.4 million, or $.25 per share, for
the six months ended June 30, 2000. Income from continuing operations was $128.1
million, or $.62 per share (diluted), for the six months ended June 30, 2001,
compared to $59.1 million, or $.29 per share, for the same period of the prior
year.
NET REVENUES AND GROSS PROFIT
Net revenues for the six months ended June 30, 2001, totaled $561.7
million, an increase of $193.6 million, or 53%, from the $368.1 million reported
in the same period of the prior year. This increase was comprised of increases
of $139 million, $47 million and $13 million in net revenues from North
American, Latin American and European subsidiaries, respectively.
North American subsidiaries net revenues totaled $302 million for the
six months ended June 30, 2001, compared to $163 million for the same period of
2000. The $139 million, or 86%, increase in net revenues was primarily
attributable to increased sales volume, in part due to new product releases,
including net sales of paclitaxel of $127 million, partially offset by higher
sales returns and allowances. North American subsidiaries recorded provisions
for sales returns and allowances that reduced gross sales by $139.2 million and
$82.8 million in 2001 and 2000, respectively. The increase of $56.4 million, or
41%, was primarily due to reduced prices on certain brand-equivalent
pharmaceutical products and increase in sales volume.
European subsidiaries generated net revenue of $196.3 million for the
six months ended June 30, 2001, compared to $183.8 million for the same period
of the prior year. The $12.5 million, or 6.8%, increase in net revenues was
primarily due to higher sales volume of respiratory products and increased
product development fees partially offset by the effect of unfavorable exchange
rates and lower prices for certain brand-equivalent pharmaceutical products.
European subsidiaries recorded provisions for sales returns and allowances that
reduced gross sales by $16.5 million and $12.4 million in 2001 and 2000,
respectively.
Latin American subsidiaries generated net revenues of $65.7 million for
the six months ended June 30, 2001, compared to $19.1 million for the same
period of the prior year. The increase was primarily due to the sales volume of
Laboratorios Elmor, S.A. ("Elmor") and Laboratorios Fustery, S.A. de
C.V.("Fustery"), which were acquired June 19, 2000 and February 9, 2001,
respectively.
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Gross profit for the six months ended June 30, 2001, increased $117
million, or 66%, from the same period of the prior year. Gross profit was $294.7
million (52% of net revenues) for the six months ended June 30, 2001, compared
to $177.7 million (48% of net revenues) for the six months ended June 30, 2000.
The increase in gross profit percentage was primarily attributable to the launch
of paclitaxel in North America and higher margin sales from the operations of
Elmor, Wakefield Pharmaceuticals, Inc. ("Wakefield") and Fustery.
OPERATING EXPENSES
Selling expenses totaled $57.6 million (10% of net revenues) for the
six months ended June 30, 2001, compared to $38.6 million (10.5% of net
revenues) for the six months ended June 30, 2000, an increase of $19 million, or
49%. The increase was due to higher expense from the operations of Elmor,
Fustery and Wakefield and increased sales force and promotional expenses at the
European subsidiaries.
General and administrative expenses totaled $52.6 million (9.4% of net
revenues) for the six months ended June 30, 2001, compared to $42.8 million
(11.6% of net revenues) for the six months ended June 30, 2000, an increase of
$9.8 million, or 22.9%. The increase is due to increased professional fees at
Corporate, additional general and administrative expenses from the operations of
Elmor, Fustery and Wakefield and patent write-offs at the United Kingdom
subsidiary.
Research and development expenses for the six months ended June 30,
2001, increased $6.2 million, or 19%, to a total of $38.9 million (6.9% of net
revenues), compared to $32.6 million (8.9% of net revenues) for the six months
ended June 30, 2000. IVAX' future level of research and development expenditures
will depend on, among other things, the outcome of clinical testing of products
under development, delays or changes in government required testing and approval
procedures, technological and competitive developments, strategic marketing
decisions and liquidity.
Amortization expense for the six months ended June 30, 2001, increased
$4 million, from $3.8 million to $7.8 million, due to the amortization of
goodwill arising from the acquisitions of Elmor and Fustery.
OTHER INCOME (EXPENSE)
Interest income and interest expense increased $9.1 million and $7.6
million, respectively, for the six months ended June 30, 2001, as compared to
the six months ended June 30, 2000. The increases in interest income and expense
are due primarily to additional cash on hand and indebtedness from the issuance
of $725 million of 4.5% Convertible Senior Subordinated Notes in May 2001.
Other income, net increased $5.2 million for the six months ended June
30, 2001, as compared to the six months ended June 30, 2000. The increase is
primarily due to $4.2 million of milestone fees and $3.6 million of investment
gains partially offset by foreign currency losses at various European
subsidiaries. Additionally, IVAX recorded a gain on the partial sale of IVAX
Diagnostics, Inc. of $10.3 million in connection with IVAX Diagnostics, Inc.'s
merger with b2bstores.com, Inc. While IVAX does not currently have plans to sell
additional shares of subsidiaries, such transactions could occur in the future.
THREE MONTHS ENDED JUNE 30, 2001 COMPARED TO THE THREE MONTHS ENDED JUNE 30,
2000
Net income was $67.9 million, or $.33 per share (diluted), for the
three months ended June 30, 2001, compared to $30.2 million, or $.15 per share,
for the three months ended June 30, 2000. Income from continuing operations was
$67.9 million, or $.33 per share (diluted), for the three months ended June 30,
2001, compared to $32.5 million, or $.16 per share, for the same period of the
prior year.
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NET REVENUES AND GROSS PROFIT
Net revenues for the three months ended June 30, 2001, totaled $301.8
million, an increase of $117 million, or 63%, from the $184.8 million reported
in the same period of the prior year. This increase was comprised of increases
of $82.7 million, $28.1 million and $10.8 million in net revenues from North
American, Latin American and European subsidiaries, respectively.
North American subsidiaries net revenues totaled $162.5 million for the
three months ended June 30, 2001, compared to $79.8 million for the same period
of 2000. The $82.7 million, or 104%, increase in net revenues was primarily
attributable to increased sales volume, in part due to new product releases,
including net sales of paclitaxel of $77 million, partially offset by higher
sales returns and allowances. North American subsidiaries recorded provisions
for sales returns and allowances that reduced gross sales by $81.3 million and
$44.8 million in 2001 and 2000, respectively. The increase of $36.5 million, or
81%, was primarily due to reduced prices on certain brand-equivalent
pharmaceutical products and increase in sales volume.
European subsidiaries generated net revenue of $103 million for the
three months ended June 30, 2001, compared to $92.2 million for the same period
of the prior year. The $10.9 million, or 11.8%, increase in net revenues was
primarily due to higher sales volume of respiratory products and increased
product development fees partially offset by the effect of unfavorable exchange
rates, and lower prices for certain brand-equivalent pharmaceutical products.
European subsidiaries recorded provisions for sales returns and allowances that
reduced gross sales by $6.8 million and $6.3 million in 2001 and 2000,
respectively.
Latin American subsidiaries generated net revenues of $39 million for
the three months ended June 30, 2001, compared to $10.9 million for the same
period of the prior year. The increase was primarily due to the sales volume of
Elmor and Fustery, which were acquired June 19, 2000 and February 9, 2001,
respectively.
Gross profit for the three months ended June 30, 2001, increased $68.8
million, or 77%, from the same period of the prior year. Gross profit was $158.4
million (52.5% of net revenues) for the three months ended June 30, 2001,
compared to $89.6 million (48.5% of net revenues) for the three months ended
June 30, 2000. The increase in gross profit percentage is primarily due to the
launch of paclitaxel in North America, higher margin sales from the operations
of Elmor and Fustery offset by increased sales returns and allowances.
OPERATING EXPENSES
Selling expenses totaled $30.1 million (10% of net revenues) for the
three months ended June 30, 2001, compared to $20.6 million (11% of net
revenues) for the three months ended June 30, 2000, an increase of $9.5 million,
or 46%. The increase was due to higher expense from the operations of Elmor,
Wakefield and Fustery, and increased promotional expenses at the European
subsidiaries.
General and administrative expenses totaled $28.9 million (9.6% of net
revenues) for the three months ended June 30, 2001, compared to $18.6 million
(10.1% of net revenues) for the three months ended June 30, 2000, an increase of
$10.3 million, or 55%. The increase is due to higher legal fees at Corporate,
additional general and administrative expenses from the operations of Elmor and
Fustery and patent write-offs at the United Kingdom subsidiary.
Research and development expenses for the three months ended June 30,
2001, increased $2.8 million, or 17%, to a total of $20 million (7% of net
revenues), compared to $17.1 million (9.3% of net revenues) for the three months
ended June 30, 2000. IVAX' future level of research and development expenditures
will depend on, among other things, the outcome of clinical testing of products
under development, delays or changes in government
19
21
required testing and approval procedures, technological and competitive
developments, strategic marketing decisions and liquidity.
OTHER INCOME (EXPENSE)
Interest income increased $6.3 million and interest expense increased
$5.3 million for the three months ended June 30, 2001, as compared to the three
months ended June 30, 2000, as a result of additional cash on hand and
indebtedness from the issuance of $725 million of 4.5% Convertible Senior
Subordinated Notes in May 2001. Other income, net increased $8 million for the
three months ended June 30, 2001, as compared to the three months ended June 30,
2000, as a result primarily of $4.2 million of milestone fees and $3.6 million
of investment gains.
RECENTLY ISSUED ACCOUNTING STANDARDS
Effective January 1, 2001, IVAX adopted SFAS No. 133, which establishes
accounting and reporting standards for derivative instruments, including certain
derivative instruments embedded in other contracts and for hedging activities.
All derivatives, whether designated in hedging relationships or not, are
required to be recorded on the balance sheet at fair value. If the derivative is
designated as a fair value hedge, the changes in the fair value of the
derivative and of the hedged item attributable to the hedged risk are recognized
in earnings. If the derivative is designated as a cash flow hedge, the effective
portions of changes in the fair value of the derivative are recorded in
Accumulated Other Comprehensive Loss ("OCL") and are recognized in the income
statement when the hedged item affects earnings. Ineffective portions of changes
in the fair value of cash flow hedges are recognized in earnings.
Certain forecasted transactions are exposed to foreign currency risk.
The principal currency hedged is the Irish punt against the British pound.
Forward options used to hedge a portion of forecasted international expenses for
up to one year in the future are designated as cash flow hedging instruments.
The adoption of SFAS 133 on January 1, 2001, resulted in an increase to OCL of
$1.6 million, net of tax of $.2 million. The increase to OCL is mostly
attributable to gains on cash flow hedges. The net derivative gains included in
OCL as of January 1, 2001, will be reclassified into earnings during the twelve
months ended December 31, 2001.
During the first quarter of 2001, IVAX adopted EITF Issue No. 00-19,
ACCOUNTING FOR DERIVATIVE FINANCIAL INSTRUMENTS INDEXED TO, AND POTENTIALLY
SETTLED IN, A COMPANY'S OWN STOCK, which addresses the classification and
accounting treatment of equity derivative contracts (such as IVAX' put options)
as equity instruments (either temporary or permanent) or assets and liabilities.
As a result, put options were reclassified from temporary equity to permanent
20
22
equity. As of June 30, 2001, IVAX had outstanding a freestanding put option for
281,000 shares of IVAX' common stock that was issued in connection with the
share repurchase program. The put option bore a strike price of $27.68 and
expired in July 2001.
During the first quarter of 2001, IVAX adopted Issue #3 of EITF Issue
No. 00-22, ACCOUNTING FOR POINTS AND CERTAIN OTHER TIME OR VOLUME BASED SALES
INCENTIVE OFFERS AND OFFERS FOR FREE PRODUCTS OR SERVICES TO BE DELIVERED IN THE
FUTURE. Final consensus was reached on the recognition, measurement and income
statement classification of cash rebates or refunds that are time and volume
based. Final consensus has not been reached on four other items under
consideration. EITF 00-22 requires that cash rebates or refunds redeemable if
the customer completes a specified cumulative level of revenue transactions or
remains a customer for a specified time period should be recognized as a
reduction of revenue based on a systematic and rational allocation of the cost
of honoring the rebate or refund earned and claimed to each of the underlying
revenue transactions that result in progress toward earning the rebate or
refund. The effective date of adoption is fiscal quarters ending after February
15, 2001. The impact of adoption was not significant.
Effective July 1, 2001, IVAX adopted SFAS 141, BUSINESS COMBINATIONS,
which addresses the financial accounting and reporting for business
combinations. It supersedes APB Opinion No. 16, BUSINESS COMBINATIONS, and SFAS
38, ACCOUNTING FOR PRE-ACQUISITION CONTINGENCIES OF PURCHASED ENTERPRISES. All
business combinations under the scope of this statement must be accounted for
using the purchase method of accounting. This statement applies to all business
combinations initiated after June 30, 2001. Management believes that adoption of
SFAS 141 will not have a material impact on the company's financial condition or
statement of operations.
SFAS 142, GOODWILL AND OTHER INTANGIBLE ASSETS, addresses financial
accounting and reporting for acquired goodwill and other intangible assets and
supersedes APB Opinion No. 17, INTANGIBLE ASSETS. It addresses accounting for
intangible assets that are acquired individually or with a group of other assets
(but not those acquired in a business combination) upon acquisition. It also
addresses accounting for goodwill and other intangible assets after they have
been initially recognized in the financial statements. Intangible assets that
have indefinite lives and goodwill will no longer be amortized, but rather they
must be tested at least annually for impairment using fair values. Intangible
assets that have finite useful lives will be amortized over their useful lives.
The statement is effective in fiscal years beginning after December 15, 2001;
except that goodwill and intangible assets acquired after June 30, 2001, will be
subject immediately to the non-amortization and amortization provisions of this
statement. Beginning in 2002, IVAX will reverse the entire balance of negative
goodwill recorded in the balance sheet as of January 1, 2002, of $4.2 million,
through a cumulative effect of a change in accounting principle; thereby
increasing net income by this amount for the year. In addition, amortization of
goodwill acquired prior to June 30, 2001, will cease. This will increase net
income by approximately $2.7 million per quarter, or $10.8 million per year.
However, management is unable to estimate the extent of impairment, if any, of
intangible assets with indefinite lives and goodwill, that may need to be
recorded in 2002 or future years.
LIQUIDITY AND CAPITAL RESOURCES
At June 30, 2001, IVAX' working capital was $1,145 million, compared to
$438.5 million at December 31, 2000. Cash and cash equivalents totaled $921.1
million at June 30, 2001, as compared to $251.5 million at December 31, 2000. On
July 5, 2001, IVAX acquired 99.6% of Laboratorio Chile S.A. ("Lab Chile") for
$382.8 million in cash, net of cash acquired. See Note 15, Subsequent Events, in
the Notes to Consolidated Financial Statements for additional information.
Net cash of $93 million was provided by operating activities during
the first six months of 2001, compared to $42.1 million during the same period
21
23
of 2000. The increase in cash provided by operating activities was primarily the
result of improved operating earnings, partially offset by an increase in
current assets.
Net cash of $84.7 million was used for investing activities during the
first six months of 2001, as compared to $23.4 million during the same period of
the prior year. During the first six months of 2001, $79.8 million was used to
acquire new businesses, consisting of $73.5 million for Fustery and $4.7 million
for the assets of a U.S. research organization, partially offset by $1 million
of net cash provided from the acquisition of Netpharma Scandinavia AB. During
the first six months of 2000, IVAX spent $5.4 million to acquire new businesses,
primarily Elmor. During the first six months of 2001, IVAX spent $10.9 million
to acquire patents and other intangibles, primarily the exclusive rights to
develop and market Talampanel, compared to $1.5 million used to acquire patents
and other intangible assets during the six months ended June 30, 2000. IVAX
spent $24.1 million on capital expenditures during the first six months of 2001
compared to $19.3 million in the same period of the prior year. During 2001,
IVAX purchased American Depositary Shares ("ADS") of Lab Chile for a total of
$18.4 million, which were subsequently sold at a profit of $3.6 million prior to
commencement of the tender offer for Lab Chile in the same period. In addition,
IVAX' wholly owned subsidiary, IVAX Diagnostics, Inc., was merged with
b2bstores.com which provided cash of $22.3 million.
Net cash of $659.1 million was provided by financing activities during
the first six months of 2001, compared to $216.3 million provided during the
same period of the prior year, primarily reflecting the $725 million Convertible
Senior Subordinated Notes sold in May of 2001, as compared to the $250 million
Convertible Senior Subordinated Notes sold in May 2000. The proceeds from the
$725 million Convertible Senior Subordinated Notes were partially offset by the
$58.6 million repurchase of IVAX' Common Stock during the first six months of
2001.
IVAX plans to spend substantial amounts of capital in 2001 to continue
the research and development of pharmaceutical products. Although research and
development expenditures are expected to be between $80 million and $90 million
during 2001, actual expenditures will depend on, among other things, the outcome
of clinical testing or products under development, delays or changes in
government required testing and approval procedures, technological and
competitive developments, strategic marketing decisions and liquidity. In
addition, IVAX plans to spend between $60 million and $70 million in 2001 to
improve and expand its pharmaceutical and other related facilities.
CURRENCY FLUCTUATIONS
For the six months ended June 30, 2001 and 2000, approximately 47% and
55%, respectively, of IVAX' net revenues were attributable to operations which
principally generated revenues in currencies other than the United States
dollar. Fluctuations in the value of foreign currencies relative to the United
States dollar affect the reported results of operations for IVAX. If the United
States dollar weakens relative to the foreign currency, the earnings generated
in the foreign currency will, in effect, increase when converted into United
States dollars and vice versa. Although IVAX does not speculate in the foreign
exchange market, it does, from time to time, manage exposures that arise in the
normal course of business related to fluctuations in foreign currency exchange
rates by entering into offsetting positions through the use of foreign exchange
forward contracts. As a result of exchange rate differences, net revenues
decreased by approximately $13.6 million for the six months ended June 30, 2001,
as compared to the same period of the prior year.
INCOME TAXES
IVAX recognized a $30.0 million tax provision for the six months ended
June 30, 2001, of which $6.5 million related to foreign operations. The $23.5
million tax provision recognized by domestic operations was favorably impacted
by $13.3 million from utilization of previously reserved net operating loss and
tax credit carryforwards and the non-taxable gain on the partial sale of IVAX
Diagnostics, Inc. offset by a $7.6 million tax provision associated with a U.S.
taxable gain on the intercompany assignment of a contract, which was eliminated
for financial reporting purposes. Payment of the current tax liability for the
year ended December 31, 2001, for domestic and foreign operations will be
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reduced by $5.6 million and $2.1 million, respectively, representing the
incremental impact of compensation expense deductions associated with
non-qualified stock option exercises during the six months ended June 30, 2001.
These amounts were credited to "Capital in excess of par value".
During the second quarter of 2001, $11.2 million of the valuation
allowance previously recorded against the domestic net deferred tax asset was
reversed due to management's expectation of increased domestic taxable income in
future years partially offset by $7.4 million tax effect of prior years' stock
option exercises, which was credited to "Capital in excess of par value". In
addition, during the second quarter of 2001, domestic deferred tax assets of
$13.4 million were recognized relating to originating temporary differences and
to reversal, through the effective rate calculation, of the valuation allowance
previously recorded against the domestic net deferred tax asset based on
management's expectation of increased domestic taxable income in the current
year. As of June 30, 2001, a domestic net deferred tax asset of $66.5 million
and an aggregate foreign net deferred tax asset, in jurisdictions with positive
net deferred tax assets, of $8.1 million are included in "Other current assets"
and "Other assets" in the accompanying consolidated balance sheet. The domestic
net deferred tax asset was approximately 19% reserved as of June 30, 2001.
Realization of the net deferred tax assets is dependent upon generating
sufficient future domestic and foreign taxable income. Although realization is
not assured, management believes it is more likely than not that the net
deferred tax assets will be realized. Management's estimates of future taxable
income are subject to revision due to, among other things, regulatory and
competitive factors affecting the pharmaceutical industries in the markets in
which IVAX operates. Such factors are further discussed in management's
discussion and analysis of financial condition and results of operations
included in IVAX' Annual Report on Form 10-K for the year ended December 31,
2000.
SALES RETURNS AND ALLOWANCES
IVAX' pharmaceutical revenues may be affected by the level of
provisions for estimated returns, inventory credits and chargebacks, as well as
other sales allowances established by IVAX. The custom in the pharmaceutical
industry is generally to grant customers the right to return purchased goods. In
the brand-equivalent pharmaceutical industry, this custom has resulted in a
practice of suppliers issuing inventory credits (also known as shelf-stock
adjustments) to customers based on the customers' existing inventory following
decreases in the market price of the related brand-equivalent pharmaceutical
product. Therefore, if new competitors enter the marketplace and significantly
lower the prices of any of our products, we may have to provide additional
credits that could reduce sales and gross margin. The determination to grant a
credit to a customer following a price decrease is generally at the discretion
of IVAX, and generally not pursuant to contractual agreements with customers.
These credits allow customers with established inventories to compete with those
buying product at the current market price, and allow IVAX to maintain shelf
space, market share and customer loyalty.
Provisions for estimated returns, inventory credits, and chargebacks,
as well as other sales allowances are established by IVAX concurrently with the
recognition of revenue. The provisions are established in accordance with
generally accepted accounting principles based upon consideration of a variety
of factors, including actual return and inventory credit experience for products
during the past several years by product type, the number and timing of
regulatory approvals for the product by competitors of IVAX, both historical and
projected, the market for the product, estimated customer inventory levels by
product, changes in net sales prices by product and projected economic
conditions. Actual product returns and inventory credits incurred are, however,
dependent upon future events, including price competition and the level of
customer inventories at the time of any price decreases. IVAX continually
monitors the factors that influence the pricing of its products and customer
inventory levels and makes adjustments to these provisions when management
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believes that actual product returns, inventory credits and other allowances may
differ from established reserves.
RISK OF PRODUCT LIABILITY CLAIMS
Testing, manufacturing and marketing pharmaceutical products subjects
IVAX to the risk of product liability claims. IVAX is a defendant in a number of
product liability cases, none of which IVAX believes will have a material
adverse effect on IVAX' financial condition or results of operations. IVAX
believes that it maintains an adequate amount of product liability insurance,
but there can be no assurance that its insurance will cover all existing and
future claims or that IVAX will be able to maintain existing coverage or obtain
additional coverage at reasonable rates. There can be no assurance that claims
arising under any pending or future product liability cases, whether or not
covered by insurance, will not have a material adverse effect on IVAX' financial
condition or results of operations.
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ITEM 3 - QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Market risk represents the risk of loss that may impact the
consolidated financial position, results of operations or cash flows of IVAX.
IVAX, in the normal course of doing business, is exposed to the risks associated
with foreign currency exchange rates and changes in interest rates.
FOREIGN CURRENCY EXCHANGE RATE RISK - IVAX is exposed to exchange rate
risk when its U.S. and non-U.S. subsidiaries enter into transactions denominated
in currencies other than their functional currency. Certain firmly committed
transactions are hedged with forward foreign exchange contracts. As exchange
rates change, gains and losses on the exposed transactions are partially offset
by gains and losses related to the hedging contracts. Both the exposed
transactions and the hedging contracts are translated at current spot rates,
with gains and losses included in earnings. IVAX' derivative activities, which
primarily consist of foreign exchange forward contracts, are initiated primarily
to hedge third-party transactions.
The foreign exchange forward contracts generally require IVAX to
exchange local currencies for foreign currencies based on pre-established
exchange rates at the contracts' maturity dates. If the counterparties to the
exchange contracts do not fulfill their obligations to deliver the contracted
currencies, IVAX could be at risk for currency related fluctuations. IVAX enters
into these contracts with counterparties that it believes to be credit worthy
and does not enter into any leveraged derivative transactions.
INTEREST RATE RISK - IVAX' only material debt obligations are its 4.5%
and 5.5% Convertible Senior Subordinated Notes, which bear fixed rates of
interest. IVAX believes that its exposure to market risk relating to interest
rate risk is not material.
COMMODITY PRICE RISK - IVAX does not believe it is subject to any
material risk associated with commodity prices.
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DISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS
This quarterly report on Form 10-Q contains "forward-looking
statements" within the meaning of Section 27A of the Securities Act and Section
21E of the Exchange Act. These statements relate to expectations, beliefs,
projections, future plans and strategies, anticipated events or trends and
similar expressions concerning matters that are not historical facts.
Specifically, this Form 10-Q contains forward-looking statements regarding:
o our intention to generate growth through the introductions of new
proprietary drugs, the expanded sale and distribution of our current
products, including paclitaxel, the acquisition of new businesses and
products and strategic collaborations;
o the ability of our research programs to develop improved forms of drugs,
novel compounds and new delivery systems, including the development of
improved formulations of paclitaxel and complementary products;
o our ability to integrate operations and exploit opportunities among our
subsidiaries;
o our ability to market new brand-equivalent biotech drugs and other oncology
products;
o our capability to identify, acquire and successfully integrate new
acquisitions of companies and products;
o anticipated benefits stemming from the acquisition of Laboratorio Chile;
o our ability to develop new formulations and obtain marketing authorizations
which will enable us to launch brand-equivalent products;
o our ability to further develop and market talampanel;
o our capacity to accelerate product development and commercialization by
in-licensing products and by developing new dosage forms or new therapeutic
indications for existing products;
o anticipated trends in the pharmaceutical industry and the effect of
technological advances on competition;
o our estimates regarding the capacity of our facilities;
o our intention to spend substantial amounts of capital in 2001 on research
and development and to improve and expand our pharmaceutical and other
related facilities;
o our intention to fund 2001 capital expenditures from existing cash and
internally generated funds; and
o our ability to use Laboratorio Chile and our other foreign subsidiaries to
launch our proprietary and brand-equivalent pharmaceutical products in Latin
American markets.
These forward-looking statements reflect our current views about future
events and are subject to risks, uncertainties and assumptions. We wish to
caution readers that certain important factors may have affected and could in
the future affect our actual results and could cause actual results to differ
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significantly from those expressed in any forward-looking statement. The most
important factors that could prevent us from achieving our goals, and cause the
assumptions underlying forward-looking statements and the actual results to
differ materially from those expressed in or implied by those forward-looking
statements include, but are not limited to, the following:
o difficulties in product development;
o efficacy or safety concerns with respect to marketed products, whether or
not scientifically justified, leading to recalls, withdrawals or declining
sales;
o our ability to identify potential acquisitions and to successfully acquire
and integrate such operations or products;
o that we may not realize the anticipated benefits of the acquisition of
Laboratorio Chile;
o that risks will arise from the operation of Laboratorio Chile;
o Recently, two competitors received FDA approval for the sale of their
paclitaxel products and others may receive similar approvals. As our
competitors receive regulatory approvals on paclitaxel products, they
may lower the price of such products and could gain market share;
o that our proposed spending on facilities improvement and expansion may not
be as projected;
o the ability of the company to obtain approval from the FDA to market new
pharmaceutical products;
o the acceptance of new products by the medical community as effective as
alternative forms of treatment for indicated conditions;
o the outcome of any pending or future litigation;
o the impact of new regulations or court decisions regarding the protection of
patents and the exclusivity period for the marketing of branded drugs.
We assume no responsibility for updating forward-looking statements contained in
this Form 10-Q.
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PART II - OTHER INFORMATION
ITEM 2 - CHANGES IN SECURITIES AND USE OF PROCEEDS
On May 4, 2001, IVAX sold $725.0 million of its 4.5% Convertible Senior
Subordinated Notes due 2008 to USB Warburg LLC (the "Initial Purchaser"). The
Initial Purchaser then sold the 4.5% Notes to Qualified Institutional Buyers
pursuant to Rule 144A of the Securities Act, to institutional "accredited
investors" (as defined in Rule 501 under the Securities Act) in compliance with
Regulation D under the Securities Act and to non-U.S. persons outside the United
States in compliance with Regulation S. The aggregate offering price of the 4.5%
Notes was $725.0 million and the aggregate underwriting discounts and
commissions were $18.9 million. The 4.5% Notes are convertible at any time prior
to maturity, unless previously redeemed, into 24.96875 shares of IVAX' common
stock per $1,000 of principal amount of the 4.5% Notes. This ratio results in a
conversion price of approximately $40.05 per share. The 4.5% Notes are
redeemable by IVAX on or after May 29, 2004. The net proceeds from the sale of
the 4.5% Notes are expected to be used to fund the acquisition of businesses and
products, to fund the research, development, testing and commercialization of
IVAX' pharmaceutical products, and for general working capital purposes.
ITEM 4 - SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
IVAX' annual meeting of shareholders was held on June 15, 2001. The
following is a summary of the matters voted on at that meeting:
The shareholders elected the entire Board of Directors. The persons
elected to IVAX' Board of Directors and the number of votes cast for and
withheld for each nominee for director were as follows:
DIRECTOR FOR WITHHELD
-------- --- --------
Mark Andrews 142,680,330 2,171,282
Ernst Biekert, Ph.D. 142,645,095 2,206,517
Charles M. Fernandez 133,961,594 10,890,018
Jack Fishman, Ph.D. 134,809,532 10,042,080
Neil Flanzraich 126,818,161 18,033,451
Phillip Frost, M.D. 126,032,562 18,819,050
Jane Hsiao, Ph.D. 118,993,266 25,858,346
Isaac Kaye 126,787,564 18,064,048
ITEM 6 - EXHIBITS AND REPORTS ON FORM 8-K
(a) EXHIBITS
None.
(b) REPORTS ON FORM 8-K
On April 30, 2001, IVAX filed a report dated April 30, 2001
under Item 5 - Other Events and Regulation FD Disclosure on Form 8-K
reporting its results of operations for the first quarter of 2001.
On May 25, 2001, IVAX filed a report dated May 18, 2001 under
Item 5 - Other Events and Regulation FD Disclosure on Form 8-K reporting
it entered into an agreement with Comercial e Inversiones Portfolio
Limitada and Inversiones Portfolio S.A. (collectively "Portfolio") to
make a cash tender offer for all of the common stock of Laboratorio Chile
and that Portfolio had agreed to tender its shares to IVAX in the tender
offer.
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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.
IVAX CORPORATION
Date: August 14, 2001 By: /s/ THOMAS E. BEIER
-------------------------------
Thomas E. Beier
Senior Vice President-Finance
Chief Financial Officer
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