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 September 30, 2000
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.
159,409,011 shares of Common Stock, $.10 par value, outstanding as of October
31, 2000.
IVAX CORPORATION
INDEX
PART I - FINANCIAL INFORMATION PAGE NO.
--------
Item 1 - Financial Statements
Consolidated Balance Sheets as of September 30, 2000
and December 31, 1999 2
Consolidated Statements of Operations
for the three months and nine months ended September 30, 2000 and 1999 3
Consolidated Statements of Cash Flows
for the nine months ended September 30, 2000 and 1999 4
Notes to Consolidated Financial Statements 5
Item 2 - Management's Discussion and Analysis of Financial Condition and
Results of Operations 14
Item 3 - Quantitative and Qualitative Disclosures about Market Risk 20
PART II - OTHER INFORMATION
Item 1 - Legal Proceedings 21
Item 6 - Exhibits and Reports on Form 8-K 22
PART I - FINANCIAL INFORMATION
Item 1 - Financial Statements
IVAX CORPORATION AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(In thousands, except per share data)
September 30, December 31,
2000 1999
--------- ---------
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 262,770 $ 41,408
Accounts receivable, net of allowance for doubtful
accounts of $20,950 ($22,058 in 1999) 108,197 110,472
Inventories 180,747 146,624
Other current assets 45,994 36,265
--------- ---------
Total current assets 597,708 334,769
Property, plant and equipment, net 233,330 226,198
Intangible assets, net 120,417 55,745
Other assets 42,386 17,802
--------- ---------
Total assets $ 993,841 $ 634,514
========= =========
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Loans payable $ 391 $ 746
Current portion of long-term debt 704 763
Accounts payable 42,463 48,675
Accrued income taxes payable 10,918 13,058
Accrued expenses and other current liabilities 137,860 147,154
--------- ---------
Total current liabilities 192,336 210,396
Long-term debt, net of current portion 254,025 47,854
Note payable - related party, net -- 45,619
Other long-term liabilities 13,291 8,672
Minority interest 5,212 9,414
Put options 27,687 20,188
Shareholders' equity:
Common stock, $.10 par value, authorized 350,000 shares,
issued and outstanding 159,447 shares (152,235 in 1999) 15,945 15,224
Capital in excess of par value 388,528 232,318
Retained earnings 158,398 71,689
Accumulated other comprehensive loss (61,581) (26,860)
--------- ---------
Total shareholders' equity 501,290 292,371
--------- ---------
Total liabilities and shareholders' equity $ 993,841 $ 634,514
========= =========
The accompanying Notes to Consolidated Financial Statements are an
integral part of these balance sheets.
2
IVAX CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Period Ended September 30 , Three Months Nine Months
(In thousands, except per share data) 2000 1999 2000 1999
--------- --------- --------- ---------
NET REVENUES $ 182,394 $ 163,310 $ 548,937 $ 465,235
COST OF SALES 91,888 90,512 277,759 263,012
--------- --------- --------- ---------
Gross profit 90,506 72,798 271,178 202,223
--------- --------- --------- ---------
OPERATING EXPENSES:
Selling 26,281 19,280 69,263 55,551
General and administrative 19,600 22,963 62,417 65,439
Research and development 17,016 13,351 49,678 38,129
Amortization of intangible assets 2,653 973 6,408 2,122
Restructuring accrual (reversal) (895) 586 (4,039) 586
--------- --------- --------- ---------
Total operating expenses 64,655 57,153 183,727 161,827
--------- --------- --------- ---------
Income from operations 25,851 15,645 87,451 40,396
OTHER INCOME (EXPENSE):
Interest income 4,708 1,214 9,397 5,381
Interest expense (3,637) (1,024) (10,882) (3,711)
Other income, net 8,186 5,604 13,745 10,201
--------- --------- --------- ---------
Total other income (expense), net 9,257 5,794 12,260 11,871
--------- --------- --------- ---------
Income from continuing operations before
income taxes and minority interest 35,108 21,439 99,711 52,267
PROVISION FOR INCOME TAXES 4,312 4,119 10,498 10,604
--------- --------- --------- ---------
Income from continuing operations
before minority interest 30,796 17,320 89,213 41,663
MINORITY INTEREST (95) (391) (533) (1,897)
--------- --------- --------- ---------
Income from continuing operations 30,701 16,929 88,680 39,766
INCOME FROM DISCONTINUED OPERATIONS -- 5 -- 585
--------- --------- --------- ---------
Income before extraordinary items 30,701 16,934 88,680 40,351
EXTRAORDINARY ITEMS - gain (loss) on
extinguishment of debt, net of taxes in 1999 -- 475 (2,254) 593
--------- --------- --------- ---------
NET INCOME $ 30,701 $ 17,409 $ 86,426 $ 40,944
========= ========= ========= =========
BASIC EARNINGS PER COMMON SHARE:
Continuing operations $ .19 $ .11 $ .56 $ .24
Extraordinary items -- -- (.01) .01
--------- --------- --------- ---------
Net income $ .19 $ .11 $ .55 $ .25
========= ========= ========= =========
DILUTED EARNINGS PER COMMON SHARE:
Continuing operations $ .19 $ .11 $ .54 $ .24
Extraordinary items -- -- (.01) .01
--------- --------- --------- ---------
Net income $ .19 $ .11 $ .53 $ .25
========= ========= ========= =========
WEIGHTED AVERAGE NUMBER OF COMMON
SHARES OUTSTANDING:
Basic 158,762 159,224 156,259 163,607
========= ========= ========= =========
Diluted 165,429 162,264 162,485 166,209
========= ========= ========= =========
The accompanying Notes to Consolidated Financial Statements are an
integral part of these statements.
3
IVAX CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Nine months Ended September 30 , 2000 1999
--------- ---------
(In thousands)
Cash flows from operating activities:
Net income $ 86,426 $ 40,944
Adjustments to reconcile net income to net cash
flows from operating activities:
Restructuring accrual (reversal) (4,039) 586
Depreciation and amortization 23,872 19,627
Deferred tax benefit (14,437) (2,227)
Provision for allowances for doubtful accounts 664 3,850
Minority interest 533 1,897
Equity in earnings of affiliates (556) (225)
Tax benefit from exercise of non-qualified employee stock options 13,549 --
Loss (gain) on extinguishment of debt 2,254 (912)
Gain on sale of product rights (6,074) (7,596)
Net (gain) loss on disposal of assets (480) 762
Income from discontinued operations -- (585)
Changes in assets and liabilities:
Decrease in accounts receivable 7 2,691
Increase in inventories (35,908) (12,709)
(Increase) decrease in other current assets (4,637) 7,072
Increase in other assets (6,569) (678)
Decrease in accounts payable, accrued expenses
and other current liabilities (9,908) (11,269)
Decrease in other long-term liabilities (1,298) (1,199)
Net cash provided from discontinued operations -- 585
--------- ---------
Net cash flows from operating activities 43,399 40,614
--------- ---------
Cash flows from investing activities:
Proceeds from sale of assets 417 907
Proceeds from sale of product rights 6,074 7,596
Capital expenditures (28,627) (23,710)
Acquisitions of patents, trademarks, licenses
and other intangibles (1,516) (344)
Acquisition of businesses and other (14,133) (4,490)
--------- ---------
Net cash flows from investing activities (37,785) (20,041)
--------- ---------
Cash flows from financing activities:
Borrowings on long-term debt and loans payable 251,960 2,554
Payments on long-term debt and loans payable (52,665) (33,835)
Issuance of common stock 33,733 8,320
Repurchases of common stock (13,784) (137,352)
--------- ---------
Net cash flows from financing activities 219,244 (160,313)
--------- ---------
Effect of exchange rate changes on cash (3,494) (850)
--------- ---------
Net increase (decrease) in cash and cash equivalents 221,362 (140,590)
Cash and cash equivalents at the beginning of the year 41,408 208,593
--------- ---------
Cash and cash equivalents at the end of the period $ 262,770 $ 68,003
========= =========
Supplemental disclosures:
Interest paid $ 3,268 $ 3,069
========= =========
Income tax payments, net $ 14,645 $ 6,777
========= =========
See Note 5, Acquisitions, for non-cash portion of acquisitions of Wakefield
Pharmaceuticals, Inc. and Laboratorios Elmor, S.A. and Note 6, Debt, for
information regarding non-cash conversion of 6 1/2% Convertible Subordinated
Notes to equity.
The accompanying Notes to Consolidated Financial Statements are an
integral part of these statements.
4
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 nine months ended September 30, 2000 are not necessarily indicative of
the results of operations and cash flows which may be reported for the remainder
of 2000. 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, 1999.
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:
September 30 , December 31,
2000 1999
-------- --------
Raw materials $ 72,610 $ 62,932
Work-in-process 25,769 10,773
Finished goods 82,368 72,919
-------- --------
Total $180,747 $146,624
======== ========
(3) EARNINGS PER SHARE:
A reconciliation of the denominator of the basic and diluted earnings
per share computation is as follows (in thousands):
Period Ended September 30, Three Months Nine Months
2000 1999 2000 1999
------- ------- ------- -------
Basic weighted average number of shares outstanding 158,762 159,224 156,259 163,607
Effect of dilutive securities - stock options and warrants 6,667 3,040 6,226 2,602
------- ------- ------- -------
Diluted weighted average number of shares outstanding 165,429 162,264 162,485 166,209
======= ======= ======= =======
Not included in the calculation of diluted earnings per
share because their impact is antidilutive:
Stock options outstanding 10 3,182 266 3,368
Convertible Notes/Warrants 6,730 2,063 6,730 2,063
Put options 1,000 2,250 1,000 2,250
(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
5
doubtful accounts" and "Accrued expenses and other current liabilities" in the
accompanying consolidated balance sheets in the amounts of $48,115 and $59,310,
respectively, at September 30, 2000 and $38,065 and $61,241, respectively, at
December 31, 1999.
(5) ACQUISITIONS:
During the first nine months of 2000, IVAX, through its Netherlands
subsidiary IVAX International B.V., purchased 237 additional shares of Galena,
a.s., its majority-owned subsidiary in the Czech Republic. The total cost of the
shares acquired through open market transactions during the first nine months of
2000 was $8,190. The net book value underlying the shares purchased was $5,324
resulting in goodwill of $2,866 being recorded in the accompanying consolidated
balance sheet at September 30, 2000. On September 1, 2000, Galena commenced a
tender offer for 9.26% of all outstanding shares. The tender offer was for a
period of 60 days. During the 3rd quarter, Galena acquired 40 shares of its own
stock at a cost of $1,401 through the tender offer. The book value of shares
repurchased was $1,878, resulting in negative goodwill of $477 being recorded in
the accompanying balance sheet as of September 30, 2000. Prior to these
purchases, IVAX owned 86% of the outstanding shares of Galena, a.s. At September
30, 2000, IVAX owned 96% of the outstanding shares of Galena, a.s.
On June 19, 2000 and August 2, 2000, IVAX acquired, through the
acquisition of three holding companies, Laboratorios Elmor, S.A. ("Elmor"), a
company located in Caracas, Venezuela for $63,911. Elmor manufactures, markets,
and distributes pharmaceutical products in Venezuela. On June 19, 2000, IVAX
issued 1,585 shares of IVAX common stock (valued at $55,000) and paid $5,000 in
cash for two of the holding companies. On August 1, 2000, IVAX acquired certain
other assets utilized in the business of Elmor by the purchase of the third
holding company for additional cash of $3,875 and other costs of $35. The fair
value of net assets acquired was $17,204, resulting in goodwill of $46,706 which
is included in "Intangible assets - net" in the accompanying consolidated
balance sheet at September 30, 2000. The goodwill will be amortized over 20
years. The operating results of Elmor are included in the consolidated financial
statements subsequent to the June 19, 2000 acquisition date.
On September 7, 2000, IVAX acquired Wakefield Pharmaceuticals, Inc.
("Wakefield"), a U.S. pharmaceutical company located in Georgia in exchange for
830 shares of IVAX common stock (valued at $28,273), $3,649 representing the
fair value of stock options granted, $1,365 of cash and $75 of other costs. The
fair value of net assets acquired was $7,701 resulting in goodwill of $25,661
which is included in "Intangible assets - net" in the accompanying consolidated
balance sheet at September 30, 2000. The goodwill will be amortized over 25
years. The operating results of Wakefield are included in the consolidated
financial statements subsequent to the September 7, 2000 acquisition date.
The preliminary allocation of the purchase prices of the three
acquisitions is as follows:
Fair value of assets acquired $ 35,265
Liabilities assumed 10,360
--------
24,905
Reduction of minority interest 7,202
--------
Net assets acquired 32,107
--------
Purchase price:
Cash (including related costs) 19,941
Fair value of stock issued 86,922
--------
106,863
--------
Goodwill $ 74,756
--------
6
Pro-forma information for the above acquisitions as if the purchases
occurred on January 1 of each year are presented below.
Period Ended September 30, Three Months Nine Months
(In thousands) 2000 1999 2000 1999
-------- -------- -------- --------
Revenues $184,050 $174,794 $571,937 $498,332
Net income 30,491 18,539 87,702 44,917
Diluted weighted average shares 165,564 162,399 162,620 166,344
Diluted earnings per share $ 0.18 $ 0.11 $ 0.54 $ 0.27
These proforma 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.
(6) RESTRUCTURING COSTS:
The activity in the restructuring cost accrual, as well as the
remaining reserve balance at September 30, 2000, which is included in "Accrued
expenses and other current liabilities" in the accompanying consolidated balance
sheets, is as follows:
Employee
Termination Plant
Benefits Closures Total
------- ------- -------
Balance at January 1, 2000 $ 1,560 $ 4,423 $ 5,983
Cash payments during 2000 (750) (351) (1,101)
Reversal of restructuring reserve established
in prior years (465) (3,574) (4,039)
Non-cash activity (18) 519 501
------- ------- -------
Balance at September 30, 2000 $ 327 $ 1,017 $ 1,344
======= ======= =======
The reversal, in the second quarter of 2000, of restructuring reserves
established in prior years, occurred as a result of a change in strategy to keep
the Northvale, New Jersey pharmaceutical facility operating as backup capacity
in the event of hurricane damage at the Puerto Rico facility. During the third
quarter of 2000, IVAX was released from a non-cancelable operating lease
associated with its United Kingdom restructuring program. This resulted in the
reversal of the remaining reserve that was previously established for the
present value of future minimum lease payments as of the date of the
restructuring. Also during the third quarter, reserves previously established
for certain severance payments were determined to be unnecessary and were
reversed.
(7) DEBT:
On February 9, 2000, IVAX called the remaining $43,661 balance of its 6
1/2% Convertible Subordinated Notes for redemption. On March 10, 2000, IVAX
redeemed $273 of the 6 1/2% Notes for cash. The remaining balance of the 6 1/2%
Notes were converted into 2,050 shares of IVAX' common stock in accordance with
their terms.
During the first nine months of 2000, IVAX paid $3,074 of interest to
Frost-Nevada, Limited Partnership ("FNLP"), an entity related to IVAX' Chairman
and CEO pursuant to IVAX' outstanding loan from FNLP. The loan was due January
17, 2001 and bore interest at 10%, payable quarterly. In conjunction with the
loan, FNLP was issued a warrant to purchase 750 shares of IVAX' common stock at
an exercise price of $12 per share. The warrant is exercisable through November
2006. During the first six months of 2000, IVAX amortized to interest expense
$2,128 of the value of the warrant issued to FNLP. On
7
June 30, 2000, the $50,000 loan from FNLP was repaid resulting in the write-off
of the remaining $2,254 of debt issue costs as an extraordinary item.
During May 2000, IVAX consummated a private offering of $250,000 of its
5.5% Convertible Senior Subordinated Notes due 2007 pursuant to Rule 144A under
the Securities Act of 1933, as amended (the "Securities Act"), and received net
proceeds of approximately $243,750. The 5.5% 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 5.5% Notes are convertible at any time prior to
maturity, unless previously redeemed, into .0269 shares of IVAX' common stock
per $1 of principal amount of the 5.5% Notes. This ratio results in a conversion
price of approximately $37.15 per share. The 5.5% Notes are redeemable by IVAX
on or after May 29, 2003. The net proceeds from the sale of the 5.5% Notes are
expected to be used primarily to acquire technology, products or other
businesses, to fund the research, development, testing and commercialization of
pharmaceutical products, and for general corporate purposes.
(8) INCOME TAXES:
The provision for income taxes from continuing operations consists of
the following:
Period Ended September 30, Three Months Nine Months
(In thousands) 2000 1999 2000 1999
-------- -------- -------- --------
Current:
United States $ 14,221 $ -- $ 14,471 $ 1,869
Foreign, including Puerto Rico
and U.S. Virgin Islands 1,638 3,322 10,464 10,962
Deferred (11,547) 797 (14,437) (2,227)
-------- -------- -------- --------
Provision for income taxes $ 4,312 $ 4,119 $ 10,498 $ 10,604
======== ======== ======== ========
The $14,471 current domestic tax provision for the nine months ended
September 30, 2000 was favorably impacted by $81,796 utilization of net
operating loss carryforwards, which had been previously reserved. However, the
provision includes $4,509 of alternative minimum tax expense recorded during the
third quarter of 2000. The current tax provision recognized by foreign
operations was favorably impacted by $3,180 as a result of the resolution of an
Inland Revenue audit in the United Kingdom closing tax years 1992 through 1997.
Payment of the current tax provision for the nine months ended September 30,
2000, for domestic and foreign operations will be reduced by $9,812 and $3,737,
respectively, representing the incremental impact of compensation expense
deductions associated with stock option exercises during the current year. These
amounts were credited to capital in excess of par value. During the nine months
ended September 30, 2000, $14,483 ($11,500 during the third quarter) 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. During the second quarter of 2000, IVAX recognized a $45,000 U.S.
taxable gain on the intercompany sale of certain assets. This taxable gain is
not included in book income as it was eliminated in consolidation.
As of September 30, 2000, a domestic net deferred tax asset of $25,842
and a foreign net deferred tax asset of $10,026 are included in "Other current
assets" and "Other assets", respectively, in the accompanying consolidated
balance sheet. The domestic net deferred tax asset includes a valuation
allowance of $66,422, or 72%, of the deferred tax asset balance. Approximately
$16,220 of the valuation allowance relates to the tax benefit of stock options
exercised which has not yet been credited to capital in excess of par value.
Realization of the net deferred tax assets is dependent upon generating
sufficient future domestic and
8
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.
(9) SHAREHOLDERS' EQUITY:
On January 14, 2000, IVAX' Board of Directors approved a 3-for-2 stock
split effective February 22, 2000, in the form of a stock dividend. All weighted
average share, outstanding share, 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 $5,097.
During 1999, IVAX issued 2,250 freestanding put options for IVAX common
stock in connection with its share repurchase program, as approved by the Board
of Directors. These put options generated premiums totaling $2,079 which were
credited to "Capital in excess of par value" in the accompanying consolidated
balance sheet at December 31, 1999. As of September 30, 2000, the put options
expired unexercised.
On August 18, 2000, IVAX issued 1,000 freestanding put options for IVAX
common stock in connection with its share repurchase program. The put options
bear a strike price of $27.69, will mature in November 2000 and February 2001,
and generated premiums totaling $3,876 which were credited to "Capital in excess
of par value" in the accompanying consolidated balance sheet at September 30,
2000. In the event the put options are exercised, IVAX may elect to settle by
one of three methods: physical settlement by payment in exchange for IVAX
shares, net cash settlement or net share settlement. The maximum potential
repurchase obligation of $27,687 for physical settlement has been reclassified
from "Capital in excess of par value" into a temporary equity account - "Put
options" in the accompanying consolidated balance sheet at September 30, 2000.
At IVAX' June 15, 2000 Annual Meeting of Shareholders, an increase in
the number of authorized shares of common stock from 250,000 to 350,000 was
approved.
In 1997, 1998, and 1999, IVAX' Board of Directors approved repurchases
of up to 36,000 shares of its common stock under a share repurchase program.
During the third quarter of 2000, IVAX repurchased 604 shares of IVAX common
stock at a total cost including commissions of $17,660. Cumulatively through
September 30, 2000, IVAX had repurchased 33,501 shares at a total cost,
including commissions, of $304,990.
(10) COMPREHENSIVE INCOME:
The components of IVAX' comprehensive income were as follows:
Period Ended September 30, Three Months Nine Months
(In thousands) 2000 1999 2000 1999
-------- -------- -------- --------
Net income $ 30,701 $ 17,409 $ 86,426 $ 40,944
Unrealized gains (losses) on marketable
securities, net of taxes (95) (51) 89 (26)
Foreign currency translation adjustments (10,455) 12,580 (34,810) (9,548)
-------- -------- -------- --------
Comprehensive income $ 20,151 $ 29,938 $ 51,705 $ 31,370
======== ======== ======== ========
(11) BUSINESS SEGMENT INFORMATION:
IVAX is a holding 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.
9
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 in
the United States and Canada. The Europe region contains subsidiaries located in
Europe. Latin America consists of subsidiaries in South America. 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, were 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.
Revenues by Region
Period Ended September 30, Three Months Nine Months
(In thousands) 2000 1999 2000 1999
--------- --------- --------- ---------
North America
External sales $ 71,087 $ 62,239 $ 213,299 $ 181,817
Intersegment sales 121 178 422 315
Other revenues 274 5,042 20,281 18,542
--------- --------- --------- ---------
Net revenue - North America 71,482 67,459 234,002 200,674
--------- --------- --------- ---------
Europe
External sales 62,202 63,920 205,220 193,925
Intersegment sales 6,786 11,464 22,387 13,294
Other revenues 20,218 5,911 43,904 13,294
--------- --------- --------- ---------
Net Revenue - Europe 89,206 81,295 271,511 220,513
--------- --------- --------- ---------
Latin America
External sales 19,240 8,402 37,531 23,317
Other revenues 378 332 1,188 1,126
--------- --------- --------- ---------
Net revenue - Latin America 19,618 8,734 38,719 24,443
--------- --------- --------- ---------
Corporate & Other
External sales 9,099 17,457 27,605 33,207
Intersegment sales (6,907) (11,642) (22,809) (13,609)
Other revenues (104) 7 (91) 7
--------- --------- --------- ---------
Net revenue - Corporate & other 2,088 5,822 4,705 19,605
--------- --------- --------- ---------
Consolidated net revenues $ 182,394 $ 163,310 $ 548,937 $ 465,235
========= ========= ========= =========
10
Profits by Region
Period Ended September 30, Three Months Nine Months
(In thousands) 2000 1999 2000 1999
-------- -------- -------- --------
Income from continuing operations
before minority interest:
North America $ 9,222 $ 12,346 $ 62,324 $ 26,308
Europe 10,291 5,595 16,979 13,679
Latin America 539 268 1,397 614
Corporate & Other 10,744 (889) 8,513 1,062
-------- -------- -------- --------
Income from continuing operations
before minority interest 30,796 17,320 89,213 41,663
-------- -------- -------- --------
Net Income:
Minority interest (95) (391) (533) (1,897)
Income from discontinued operations -- 5 -- 585
Extraordinary items -- 475 (2,254) 593
-------- -------- -------- --------
Net Income $ 30,701 $ 17,409 $ 86,426 $ 40,944
======== ======== ======== ========
September 30,
Long-Lived Assets: 2000 1999
-------- --------
North America $ 57,279 $ 54,808
Europe 215,706 184,761
Latin America 65,012 7,610
Corporate & Other 36,065 24,241
-------- --------
Total $374,062 $271,420
======== ========
(12) RECENTLY ISSUED ACCOUNTING STANDARDS:
IVAX is required to adopt SFAS No. 133, Accounting for Derivative
Instruments and Hedging Activities, as amended by SFAS 137 and 138, in the first
quarter of 2001. SFAS No. 133, as amended, establishes accounting and reporting
standards for derivative instruments, including certain derivative instruments
embedded in other contracts, and for hedging activities. It requires that an
entity recognize all derivatives as either assets or liabilities in the balance
sheet and measure those instruments at fair value. Management believes that the
adoption of SFAS No. 133, as amended, will not have a material impact on IVAX'
consolidated financial statements.
In December 1999, the SEC issued Staff Accounting Bulletin No. 101,
Revenue Recognition in Financial Statements ("SAB No. 101"), which, as amended,
requires implementation in the fourth quarter of 2000. As a result, IVAX
commenced a review of its revenue recognition policies for conformity with SAB
No. 101. IVAX believes its revenue recognition policies comply with the guidance
provided in SAB No. 101, except with respect to up-front cash payments received
under certain licensing arrangements. SAB No. 101 generally provides that
up-front payments, whether or not they are refundable, should be deferred as
revenue and recognized over the license period. IVAX' accounting policy is to
immediately recognize as revenue such cash payments that are nonrefundable or
where the probability of refund is remote. IVAX believes its accounting policy
is in accordance with generally accepted accounting principles and practice in
the pharmaceutical industry.
SAB No. 101 will require IVAX to change its accounting method for one
such licensing payment. This arrangement will result in a cumulative change in
accounting principle charge of approximately $6,300, net of tax, when SAB No.
101 is implemented in the fourth quarter of 2000. The offsetting impact will
11
result in deferred revenue which will be recognized in income through 2011. In
accordance with generally accepted accounting principles, the cumulative effect
of the change in accounting principle must be retroactively adopted as of the
beginning of the first quarter of 2000.
In May 2000, the EITF reached consensus on Issue No. 00-14, "Accounting
for Coupons, Rebates, and Discounts", which prescribes the accounting for and
classification of sales rebates and discounts. At its July 19-20 meeting the
EITF delayed the transition date to correspond with implementation of SAB No.
101. Implementation of EITF No. 00-14 is not expected to have a significant
impact on IVAX' results of operations.
(13) LEGAL PROCEEDINGS:
On April 20, 2000, the appellate court denied the plaintiffs' motion
for rehearing in the case Alan M. Harris et al. v. IVAX Corporation, Phillip
Frost, et al., previously reported in IVAX' Annual Report on Form 10-K for the
year ended December 31, 1999.
On July 6, 2000, the appellate court affirmed the dismissal of the
complaint in the case Malin, et al. v. IVAX Corporation, Phillip Frost, et al.,
previously reported in IVAX' Annual Report on Form 10-K for the year ended
December 31, 1999.
Zenith Goldline has been named in four additional class action lawsuits
containing allegations similar to those in the Louisiana Wholesale case,
previously reported in IVAX' Annual Report on Form 10-K for the year ended
December 31, 1999.
On November 1, 2000, Eli Lilly and Company voluntarily dismissed its
complaint against Zenith Goldline in the case Eli Lilly and Company v. Roussel
Corp., et al., previously reported in IVAX' Annual Report on Form 10-K for the
year ended December 31, 1999.
Paclitaxel Related Litigation
On March 26, 1998, Bristol Myers Squibb Company ("BMY") filed a
complaint in the United States District Court for the District of New Jersey
styled Bristol Myers Squibb Company v. Zenith Goldline Pharmaceuticals, Inc., et
al. alleging patent infringement of two of its patents relating to Taxol(R).
Zenith Goldline filed various counterclaims based on antitrust and unfair
competition. On March 3, 2000, the court granted Zenith Goldline's motion for
summary judgment of invalidity. On April 17, 2000, BMY filed an appeal which
remains pending. Zenith Goldline's counterclaims have been stayed, pending
appeal.
On August 11, 2000, American BioScience, Inc. ("ABI") filed a complaint
in the United States District Court for the Central District of California in
the case American BioScience, Inc. v. Bristol Myers Squibb Company for a
temporary restraining order and preliminary injunction compelling BMY to list in
the FDA's Orange Book ABI's '331 patent, which purportedly covers BMY's Taxol(R)
product. On August 11, 2000, the '331 patent was listed in the Orange Book
pursuant to a temporary restraining order. On September 7, 2000, the Court
entered an order which dissolved the temporary restraining order, denied ABI's
request for preliminary injunction, declined to approve the settlement between
ABI and BMY and dismissed ABI's complaint and ordered that BMY de-list the `331
patent. ABI appealed and sought a stay of the Order from the Ninth Circuit Court
of Appeals, which was denied on September 13, 2000. The appeal remains pending.
On September 7, 2000, ABI filed a lawsuit for patent infringement styled
American BioScience, Inc. v. Baker Norton Pharmaceuticals, Inc. ("BNP"), Zenith
Goldline Pharmaceuticals, Inc., and IVAX Corporation in the United States
12
District Court for Central District of California alleging infringement of its
`331 patent, which purports to cover paclitaxel. A response to the complaint has
not yet been filed.
On September 20, 2000, ABI filed a complaint in the United States
District Court for the District of Columbia styled American BioScience, Inc. v.
Donna E. Shalala, et al., which sought by temporary restraining order and
preliminary injunction a rescission of BNP's final marketing approval for its
generic paclitaxel product. Both BMY and BNP intervened in the action. On
October 3, 2000, the Court denied ABI's request for preliminary injunctive
relief. Thereafter, ABI sought an emergency injunction pending appeal from the
United States Court of Appeals for the District of Columbia Circuit, which was
also denied on October 13, 2000. ABI's appeal remains pending.
On October 16, 2000, ABI filed a complaint in the United States
District Court for the Central District of California styled American
BioScience, Inc. v. Donna E. Shalala, et al., which recites virtually the same
claims as the action ABI filed in the District of Columbia Court set out above.
BNP has moved to intervene and has opposed ABI's request for preliminary
injunction. This action remains pending.
(14) SUBSEQUENT EVENTS:
On October 12, 2000, IVAX entered into a definitive agreement to
acquire Laboratorios Fustery, S.A. de C.V. ("Fustery"), a company with
headquarters in Mexico City, Mexico, for a combination of cash and IVAX common
stock valued at approximately $117,000. Fustery manufactures, markets, and
distributes a broad range of prescription pharmaceuticals in Mexico. The
transaction is subject to approval from the Mexican government.
During October, 2000, IVAX repurchased 125 shares of IVAX common stock
under its share repurchase program at a total cost, including commissions, of
$5,425.
During October, 2000, IVAX' Czech Republic subsidiary, Galena, a.s.
acquired 31 shares of its own stock from third parties and 91 shares of its
stock from IVAX' Netherlands subsidiary, IVAX International B.V. through a
tender offer that expired on October 31, 2000. The total cost, including
commissions, of these purchases was $4,114. As a result of these transactions,
IVAX, through its Netherlands subsidiary, IVAX International B.V., owns 98% of
Galena, a.s.
13
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, 1999 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.
Except for historical information contained herein, the matters discussed below
are forward looking statements made pursuant to the safe harbor provisions of
the Private Securities Litigation Reform Act of 1995. Such statements involve
risks and uncertainties, including but not limited to economic, competitive,
governmental and technological factors affecting IVAX' operations, markets,
products and prices, the application and use of the proceeds of IVAX' offering
of its 5.5% Notes in a manner that results in the acquisition or development of
businesses or technologies that will contribute to its profitability, and other
factors discussed elsewhere in this report and the documents filed by IVAX with
the Securities and Exchange Commission ("SEC"). These factors may cause IVAX'
results to differ materially from the forward looking statements made in this
report or otherwise made by or on behalf of IVAX.
Certain prior period amounts presented have been reclassified to
conform to the current period's presentation.
Results of Operations
Nine months ended September 30, 2000 compared to the nine months ended September
30, 1999
Net income was $86.4 million, or $.53 per share (diluted), for the nine
months ended September 30, 2000, compared to $40.9 million, or $.25 per share,
for the nine months ended September 30, 1999. Income from continuing operations
was $88.7 million, or $.54 per share (diluted), for the nine months ended
September 30, 2000, compared to $39.8 million, or $.24 per share, for the same
period of the prior year.
Net Revenues and Gross Profit
Net revenues for the nine months ended September 30, 2000 totaled
$548.9 million, an increase of $83.7 million, or 18%, from the $465.2 million
reported in the same period of the prior year. The increase in net revenues was
comprised of an increase of $33.3 million from North American subsidiaries, an
increase of $51 million from European subsidiaries and an increase of $14.3
million from Latin American subsidiaries, offset by a decrease of $14.9 million
from Corporate and Other.
North American subsidiaries' net revenues totaled $234 million for the
nine months ended September 30, 2000, compared to $200.7 million for the same
period of 1999. The $33.3 million, or 16.6%, increase in net revenues is
primarily due to an increase in gross product sales of $93.6 million offset by
an increase in sales returns and allowances of $62 million. Gross product sales
increased due to higher sales volume partially offset by lower prices for
certain pharmaceutical products. The increase in sales returns and allowances is
due primarily to overall increased sales, a higher proportion of new products
leading to increased promotion expense and shelf-stock adjustments as well as
the introduction of a new generic drug by a competitor.
European subsidiaries generated net revenues of $271.5 million for the
nine months ended September 30, 2000 compared to $220.5 million for the same
period of the prior year. The $51 million, or 23.1%, increase in net revenues
from European subsidiaries was primarily due to an increase in license fees,
royalties and product development fees, received primarily from two companies,
and higher sales volume at the United Kingdom and Czech Republic subsidiaries
and was offset by the effect of unfavorable currency exchange rates of the
respective countries against the dollar.
14
Gross profit for the first nine months ended September 30, 2000
increased $69 million, or 34.1%, from the same period of the prior year. Gross
profit was $271.2 million (49.4% of net revenues) for the first nine months of
2000, compared to $202.2 million (43.5% of net revenues) for the first nine
months of 1999. The increase in the gross profit percentage is primarily due to
favorable product mix and increased other revenues partially offset by increased
sales return and allowances.
Operating Expenses
Selling expenses totaled $69.3 million (12.6% of net revenues) for the
nine months ended September 2000, compared to $55.6 million (11.9% of net
revenues) for the same period in 1999, an increase of $13.7 million, or 24.7%.
The increase was primarily attributable to increased sales force at the North
American subsidiaries and increased sales force and promotional expenses at the
European subsidiaries.
General and administrative expenses totaled $62.4 million (11.4% of net
revenues) for the nine months ended September 30, 2000, compared to $65.4
million (14.1% of net revenues) for the same period of 1999, a decrease of $3.0
million, or 4.6%. The decrease is primarily attributable to lower legal fees,
favorable resolution of certain litigation at North American subsidiaries and
lower costs at the Far East subsidiaries.
Research and development expenses totaled $49.7 million (9.1% of net
revenues) for the nine months ended September 30, 2000 compared to $38.1 million
(8.2% of net revenues) for the same period in 1999, an increase of $11.6
million, or 30.4%. 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.
During 1998, IVAX decided to cease manufacturing at its Northvale, New
Jersey plant for an estimated annual pre-tax cost savings of $3.4 million. In
the second quarter of 2000, as a result of a change in strategy to keep the
Northvale, New Jersey pharmaceutical facility operating as back-up capacity in
the event of hurricane damage at the Puerto Rico facility, the related
restructuring reserves were reversed. As a result, the estimated pre-tax cost
savings of $3.4 million will not be achieved.
Other Income (Expense)
Interest income increased $4 million due to higher levels of cash on
hand and interest expense increased $7.2 million due to the issuance of $250
million of 5.5% Convertible Senior Subordinated Notes for the nine months ended
September 30, 2000, as compared to the nine months ended September 30, 1999.
Other income, net, increased $3.5 million for the nine months ended September
30, 2000 as compared to the nine months ended September 30, 1999.
Three months ended September 30, 2000 compared to the three months ended
September 30, 1999
Net income was $30.7 million, or $0.19 per share, for the three months
ended September 30, 2000, compared to $17.4 million, or $0.11 per share, for the
three months ended September 30, 1999. Income from continuing operations was
$30.7 million, or $0.19 per share, for the three months ended September 30,
2000, compared to $16.9 million, or $0.11 per share, for the same period of the
prior year.
Net Revenues and Gross Profit
Net revenues for the three months ended September 30, 2000 totaled
$182.4 million, an increase of $19.1 million, or 11.7%, from the $163.3 million
reported in the same period of the prior year. Net revenues from North American
subsidiaries increased $4 million, Latin American subsidiaries increased $10.8
million, European subsidiaries increased $7.9 million, and Corporate and Other
decreased $3.7 million.
North American subsidiaries' net revenues totaled $71.5 million for the
three months ended September 30, 2000, compared to $67.5 million for the same
period of 1999. The $4 million, or 6%, increase in net revenues if primarily due
to an increase in gross product sales of $32.5 million offset by an increase in
sales returns and allowances of $22.7 million and a decrease in other revenues
of $4.8 million. Gross product sales increased due to higher sales volume
partially offset by lower prices for certain pharmaceutical products. The
increase in sales returns and allowances is due primarily to overall increased
sales, a higher proportion of new products leading to increased promotion
expense and shelf-stock adjustments as well as the introduction of a new generic
drug by a competitor. Other revenues decreased due to payments received in 1999
from a litigation settlement with Abbott which ceased in the first quarter of
2000.
15
European subsidiaries generated net revenues of $89.2 million for the
three months ended September 30, 2000, compared to $81.3 million for the same
period of 1999. The $7.9 million, or 9.7%, increase is due to increased license
fees, royalties and product development fees, received primarily from two
companies, and higher sales volume at the United Kingdom and Czech Republic
subsidiaries.
Gross profit for the three months ended September 30, 2000 increased
$17.7 million, or 24.3%, from the same period in the prior year. Gross profit
was $90.5 million (49.6% of net revenues) for the three months ended September
30, 2000, compared to $72.8 million (44.6% of net revenues) for the three months
ended September 30, 1999. The increase in the gross profit percentage was
primarily due to favorable product mix and increased other revenues, partially
offset by higher sales returns and allowances.
Operating Expenses
Selling expenses totaled $26.3 million (14.4% of net revenues) for the
three months ended September 30, 2000, compared to $19.3 million (11.8% of net
revenues) for the three months ended September 30, 1999, an increase of $7
million, or 36.3%. The increase was primarily attributable to increased sales
force expense at the North American subsidiaries and increased sales force and
promotional expenses at the European subsidiaries.
General and administrative expenses totaled $19.6 million (10.7% of net
revenues) for the three months ended September 30, 2000, compared to $23 million
(14.1% of net revenues) for the three months ended September 30, 1999, a
decrease of $3.4 million, or 14.6%. The decrease was due primarily to lower
legal fees at domestic operations and reduced bad debt provisions at IVAX' Asian
subsidiaries.
Research and development expenses totaled $17 million (9.3% of net
revenues) for the three months ended September 30, 2000 compared to $13.4
million (8.2% of net revenues) for the same period of the prior year, an
increase of $3.6 million, or 27%. 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.
During the third quarter of 2000, IVAX was released from a
non-cancelable operating lease associated with its United Kingdom restructuring
program. This resulted in the reversal of the remaining reserve that was
previously established for the present value of future minimum lease payments as
of the date of the restructuring. Also, during the third quarter, unused
severance reserves associated with the United Kingdom restructuring program were
reversed.
Other Income (Expense)
Interest income increased $3.5 million due to higher levels of cash on
hand and interest expense increased $2.6 million due to the issuance of $250
million of 5.5% Convertible Senior Subordinated Notes for the three months ended
September 30, 2000, as compared to the three months ended September 30, 1999.
Other income, net increased $2.6 million for the nine months ended
September 30, 2000, as compared to the nine months ended September 30, 1999.
Recently Issued Accounting Standards
In December 1999, the SEC issued Staff Accounting Bulletin No. 101,
Revenue Recognition in Financial Statements, ("SAB No. 101") which, as amended,
requires implementation in the fourth quarter of 2000.As a result, IVAX
commenced a review of its revenue recognition policies for conformity with SAB
No. 101. IVAX believes its revenue recognition policies generally comply with
the guidance provided in SAB No. 101, except with respect to up-front cash
payments received under certain licensing arrangements. SAB No. 101 generally
provides that up-front payments, whether or
16
not they are refundable, should be deferred as revenue and recognized over the
license period. IVAX' accounting policy is to immediately recognize as revenue
such cash payments that are nonrefundable or where the probability of refund is
remote. IVAX believes its accounting policy is in accordance with generally
accepted accounting principles and practice in the pharmaceutical industry.
SAB No. 101 will require IVAX to change its accounting method for one
such licensing payment. This arrangement will result in a cumulative change in
accounting principle charge of approximately $6.3 million, net of tax, when SAB
No. 101 is implemented in the fourth quarter of 2000. The offsetting impact will
result in deferred revenue that will be recognized in income through 2011. In
accordance with generally accepted accounting principles, the cumulative effect
of the change in accounting principle must be retroactively adopted as of the
beginning of the first quarter of 2000.
In May 2000, the EITF reached consensus on Issue No. 00-14, "Accounting
for Coupons, Rebates, and Discounts", which prescribes the accounting for and
classification of sales rebates and discounts. At its July 19-20 meeting the
EITF delayed the transition date to correspond with implementation of SAB No.
101. Implementation of EITF No. 00-14 is not expected to have a significant
impact on IVAX' results of operations.
Liquidity and Capital Resources
At September 30, 2000, IVAX' working capital was $405.4 million
compared to $124.4 million at December 31, 1999. Cash and cash equivalents
totaled $262.8 million at September 30, 2000, as compared to $41.4 million at
December 31, 1999.
Net cash of $43.4 million was provided by operating activities during
the first nine months of 2000, compared to $40.6 million during the same period
of the prior year. The increase in cash provided by operating activities was
primarily the result of improved operating earnings offset by increased levels
of inventory and other assets.
Net cash of $37.8 million used for investing activities during the
first nine months of 2000, was primarily attributable to $28.6 million for
capital expenditures, $14.1 million for the acquisitions of additional common
stock of Galena, a.s., the net cash portions of the acquisitions of Wakefield
Pharmaceuticals, Inc. and Laboratorios Elmor, S.A., an investment in a limited
partnership and $1.5 million for the acquisition of patents and licenses. These
uses of funds were offset by $6.1 million proceeds received from the sale of
product rights.
Net cash of $219.2 million provided from financing activities during
the first nine months of 2000, was primarily attributable to $243.8 million net
proceeds from the issuance of convertible debentures and $33.7 million from the
issuance of common stock, offset by the payment of $52.7 million of short-term
loans and $13.8 million to repurchase common stock.
During the second quarter of 2000, IVAX issued approximately 1.6
million shares of common stock to acquire Laboratorios Elmor, S.A. During the
third quarter of 2000, IVAX issued approximately 830,000 shares of common stock
to acquire Wakefield Pharmaceuticals, Inc.
IVAX plans to spend substantial amounts in 2000 to continue the
research and development of pharmaceutical products. Expenditures will depend
on, among other things, IVAX' actual
17
earnings and cash position, 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. In addition, IVAX also anticipates that it will make
significant expenditures to improve and expand its pharmaceutical and other
related facilities.
IVAX' principal sources of short-term liquidity are existing cash and
internally generated funds, which IVAX believes will be sufficient to meet its
operating needs and anticipated capital expenditures over the short term. For
the long term, IVAX intends to utilize the proceeds of the 5.5% Notes issued May
12, 2000 and internally generated funds, which are anticipated to be derived
primarily from the sale of existing pharmaceutical products and pharmaceutical
products currently under development. There can be no assurance that IVAX will
successfully complete the development of products under development, that IVAX
will be able to obtain regulatory approval for any such product, or that any
approved product may be produced in commercial quantities, at reasonable costs,
and be successfully marketed. IVAX may consider issuing additional debt or
equity securities in the future to fund potential acquisitions and growth.
Currency Fluctuations
For the nine months ended September 30, 2000 and 1999, approximately
53.2% and 53.3%, 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 $12.4 million for the nine
months ended September 30, 2000, as compared to the same periods of the prior
year.
Income Taxes
IVAX recognized a $10.5 million tax provision for the nine months ended
September 30, 2000. The $14.5 million current domestic tax provision was
favorably impacted by $81.8 million utilization of net operating loss
carryforwards, which had been previously reserved. The domestic provision
includes $4.5 million of alternative minimum tax. The $10.5 million current tax
provision recognized by foreign operations was favorably impacted by
approximately $3.3 million as a result of the resolution of an Inland Revenue
audit in the United Kingdom closing tax years 1992 through 1997. The current tax
provision for the nine months ended September 30, 2000, for domestic and foreign
operations includes $9.8 million and $3.7 million, respectively, of tax expense
representing the incremental impact on the current tax provision of compensation
expense deductions associated with stock option exercises during the current
year. These amounts were also credited to capital in excess of par value. During
the nine months ended September 30, 2000, $14.5 million ($11.5 million during
the third quarter) 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. During the second quarter of 2000, IVAX
recognized a $45 million U.S. taxable gain on the intercompany sale of certain
assets. This taxable gain is not included in book income as it was eliminated in
consolidation.
As of September 30, 2000, domestic and foreign net deferred tax assets
totaled $25.8 million and $10 million, respectively. The domestic net deferred
tax asset includes a valuation allowance of $66.4 million, or 72%, of the
deferred tax asset balance. Approximately $16.2 million of the valuation
allowance relates to the tax benefit of stock options exercised which has not
yet been credited to capital in
18
excess of par value. 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,
1999.
Sales Returns and Allowances
IVAX' pharmaceutical revenues may be affected by the level of
provisions for estimated returns and inventory credits, as well as other sales
returns and allowances established by IVAX. The custom in the pharmaceutical
industry is generally to grant customers the right to return purchased goods. In
the generic 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 generic pharmaceutical product. 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 are intended to 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 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 believes that actual product
returns and inventory credits 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.
19
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 forward foreign exchange contracts, are initiated primarily
to hedge third-party transactions.
The forward foreign exchange 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 obligation is its 5.5%
Convertible Senior Subordinated Notes, which bear a fixed rate 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.
20
PART II - OTHER INFORMATION
Item 1 - Legal Proceedings
With respect to the case pending in the United States District Court
for the District of New Jersey, styled Eli Lilly and Company v. Roussel Corp.,
et al., previously reported in IVAX' Annual Report on Form 10-K for the year
ended December 31, 1999, on November 1, 2000, Eli Lilly and Company voluntarily
dismissed its complaint against Zenith Goldline.
Paclitaxel Related Litigation
On March 26, 1998, Bristol Myers Squibb Company ("BMY") filed a
complaint in the United States District Court for the District of New Jersey
styled Bristol Myers Squibb Company v. Zenith Goldline Pharmaceuticals, Inc., et
al. alleging patent infringement of two of its patents relating to Taxol(R).
Zenith Goldline filed various counterclaims based on antitrust and unfair
competition. On March 3, 2000, the court granted Zenith Goldline's motion for
summary judgment of invalidity. On April 17, 2000, BMY filed an appeal which
remains pending. Zenith Goldline's counterclaims have been stayed, pending
appeal.
On August 11, 2000, American BioScience, Inc. filed a complaint in the
United States District Court for the Central District of California styled
American BioScience, Inc. v. Bristol Myers Squibb Company for a temporary
restraining order and preliminary injunction compelling BMY to list in the FDA's
Orange Book ABI's '331 patent, which purportedly covers BMY's Taxol(R) product.
On August 11, 2000, the '331 patent was listed in the Orange Book pursuant to a
temporary restraining order. On September 7, 2000, the Court entered an order
which dissolved the temporary restraining order, denied ABI's request for
preliminary injunction, declined to approve the settlement between ABI and BMY
and dismissed ABI's complaint and ordered that BMY de-list the `331 patent. ABI
appealed and sought a stay of the Order from the Ninth Circuit Court of Appeals,
which was denied on September 13, 2000. The appeal remains pending.
On September 7, 2000, ABI filed a lawsuit for patent infringement
styled American BioScience, Inc. v. Baker Norton Pharmaceuticals, Inc., Zenith
Goldline Pharmaceuticals, Inc., and IVAX Corporation in the United States
District Court for Central District of California alleging infringement of its
`331 patent, which purports to cover paclitaxel. A response to the complaint has
not yet been filed.
On September 20, 2000, ABI filed a complaint in the United States
District Court for the District of Columbia styled American BioScience, Inc. v.
Donna E. Shalala, et al., which sought by temporary restraining order and
preliminary injunction a rescission of BNP's final marketing approval for its
generic paclitaxel product. Both BMY and BNP intervened in the action. On
October 3, 2000, the Court denied ABI's request for preliminary injunctive
relief. Thereafter, ABI sought an emergency injunction pending appeal from the
United States Court of Appeals for the District of Columbia Circuit, which was
also denied on October 13, 2000. ABI's appeal remains pending.
On October 16, 2000, ABI filed a complaint in the United States
District Court for the Central District of California styled American
BioScience, Inc. v. Donna E. Shalala, et al., which recites virtually the same
claims as the action ABI filed in the District of Columbia Court set out above.
BNP has moved to intervene and has opposed ABI's request for preliminary
injunction. This action remains pending.
21
Item 6 - Exhibits and Reports on Form 8-K
(a) Exhibits
10.19(a) Agreement and Plan of Merger dated August 3, 2000 among Ivax
Corporation, Wakefield Pharmaceuticals, Inc., the Principal
Stockholders of Wakefield Pharmaceuticals, Inc. and WPI Merger
Corporation. Filed herewith.
10.19(b) Amendment to Agreement and Plan of Merger dated August 14, 2000
among IVAX Corporation, Wakefield Pharmaceuticals, Inc. the
Principal Stockholders of Wakefield Pharmaceuticals, Inc.
and WPI Merger Corporation. Filed herewith.
27 Financial Data Schedule Filed herewith.
(b) Reports on Form 8-K
No reports on Form 8-K were filed by IVAX during the three months ended
September 30, 2000.
22
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: November 7, 2000 By: /s/ Thomas E. Beier
--------------------------------
Thomas E. Beier
Senior Vice President-Finance
Chief Financial Officer
23
EXHIBIT INDEX
EXHIBIT DESCRIPTION
- ------- -----------
10.19(a) Agreement and Plan of Merger dated August 3, 2000 among Ivax
Corporation, Wakefield Pharmaceuticals, Inc., the Principal
Stockholders of Wakefield Pharmaceuticals, Inc. and WPI Merger
Corporation.
10.19(b) Amendment to Agreement and Plan of Merger dated August 14, 2000
among IVAX Corporation, Wakefield Pharmaceuticals, Inc. the
Principal Stockholders of Wakefield Pharmaceuticals, Inc.
and WPI Merger Corporation.
27 Financial Data Schedule
24