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Note 1 - Significant Accounting Policies:
The significant accounting policies, applied on a consistent basis, are as follows:
A. General:
1) Operations
Teva Pharmaceutical Industries Limited (the
"Company" or "Teva") is an Israeli corporation which,
together with its subsidiaries and associated companies ("Teva Group"
or "the Group"), is engaged in development, production, marketing and
distribution of products in two operating segments, Pharmaceuticals and Active
Pharmaceutical Ingredients.
2) Functional currency
The currency of the primary economic environment
in which the operations of the Company and its subsidiaries in Israel and in the
United States are conducted is the U.S. dollar ("dollar" or
"$"), this in view of the overall trend of increasing dollar sales of
the Company. Operating expenses (including purchase of materials) incurred in
non-Israeli currencies, mainly the dollar, constitute approximately 50% of the
total operating expenses of each of those companies. Most purchases of materials
are also made in non-Israeli currencies (mainly the dollar). Thus, the
functional currency of these companies is the dollar.
The functional currency of the remaining subsidiaries and associated companies,
mainly European and Canadian companies, is their local currency. The financial
statements of those companies are included in the consolidation based on
translation into dollars in accordance with Statement of Financial Accounting
Standards ("FAS") No. 52 of the Financial Accounting Standards Board
of the United States ("FASB"): assets and liabilities are translated
at year end exchange rates, while operating results items are translated at
average exchange rates during the year. Differences resulting from translation
are presented under shareholders' equity, in the item "accumulated other
comprehensive loss".
3)Accounting principles
The consolidated financial statements are
prepared in accordance with accounting principles generally accepted in the
United States.
Use of estimates in the preparation of financial statements
The preparation of financial statements in conformity with generally accepted
accounting principles requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities and disclosure of
contingent assets and liabilities at the dates of the financial statements and
the reported amounts of revenues and expenses during the reporting years. Actual
results could differ from those estimates.
B. Principles of Consolidation:
1) The consolidated financial statements include
the accounts of Teva and all of its subsidiaries. In these financial statements,
"subsidiaries" are companies controlled to the extent of over 50%, the
financial statements of which are consolidated with those of the Company.
"Associated companies" are companies controlled to the extent of 20%
or more but are not subsidiaries, the investment in which is accounted for by
the equity method. Significant intercompany transactions and balances were
eliminated in consolidation; profits from intercompany sales, not yet realized
outside the Group, have also been eliminated.
C. Inventories
These are valued at the lower of cost or market.
Cost is determined as follows:
Raw and packaging materials and purchased products - mainly on the
"first-in, first-out" basis. Finished products and products in
process: raw material and packaging component - mainly on the "first-in,
first-out" basis; labor and overhead - on the average basis over the
production period.
D. Investee companies:
These investments are included among
"Investments and other assets". Investments in associated companies
are accounted for by the equity method. Other investments are carried at cost.
E. Marketable securities:
These securities are included under
"short-term investments" and "investments and other assets"
and are classified as trading securities or available-for-sale securities.
Trading securities are carried at market value, and the changes in value are
carried to the statements of income as other income or expenses.
Available-for-sale securities are carried at market value with unrealized gains
and losses, net of tax, reported as a separate component of "other
comprehensive income (loss)".
At December 31, 2000, the Group's available - for - sale securities consisted of
equity investments. The fair market value, amortized cost and gross unrealized
holding losses at year end were $ 7.0 million, $ 8.1 million and $ 1.1 million,
respectively. The Group did not have available for sale securities at December
31, 1999.
F. Property, plant and equipment:
Property, plant and equipment are carried at
cost, after deduction of the related investment grants ($ 6.1 million and $ 4.7
million at December 31, 2000 and 1999, respectively). Equipment leased under
capital leases is classified as the Group's assets and included at the present
value of lease payments as determined by the lease agreement.
Interest expenses in respect of loans and credit applied to finance the
construction or acquisition of property, plant and equipment, incurred until the
assets are ready for their intended use, are charged to cost of such assets.
Interest capitalized for the years ended December 31, 2000, 1999 and 1998 were $
0.8 million, $ 0.7 million and $ 0.5 million, respectively.
Depreciation is computed using the straight-line method on the basis of the
estimated useful life of the assets, at the following annual rates:
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Buildings
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Mainly 4%
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Machinery and equipment
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8.33%-12.5%
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Machinery and equipment
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Motor vehicles, computer equipment,
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furniture and other assets
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Mainly 15%
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G. Intangible assets:
Intangible assets consists primarily of
goodwill, marketing and product rights and debt issuance costs. Goodwill,
representing the excess of cost of investments in subsidiaries acquired over the
fair value of net assets at acquisition, is amortized in equal annual
installments, mainly over a period of 30 years. Debt issuance costs are
amortized over the period of the debentures (mainly 5 years), using the
straight-line method. Marketing rights, product rights and other intangible
assets are stated at cost and amortized using the straight-line method over
their estimated period of useful life, as follows: marketing rights - 30 years;
product rights - mainly 12 years; other intangible assets - mainly 5-14 years.
H. Impairment in value of long-lived
assets:
The Company adopted FAS No. 121,
"Accounting for the Impairment of Long-Lived Assets and for Long-Lived
assets to be Disposed of". Under the provisions of FAS 121 the Company
reviews its property, plant and equipment and identifiable intangible assets for
impairment on an exception basis whenever events or changes in circumstances
indicate that the carrying amount of the assets may not be recoverable through
undiscounted future cash flows. If it is determined that an impairment loss has
occurred based on expected discounted future cash flows, then the loss will be
recognized in the statements of income.
I. Deferred income taxes :
Deferred taxes are determined utilizing the
asset and liability method based on the estimated future tax effects of
differences between the financial accounting and tax bases of assets and
liabilities under the applicable tax laws. Deferred income tax provisions and
benefits are based on the changes in the deferred tax asset or tax liability
from period to period. Taxes which would apply in the event of disposal of
investments in subsidiaries have not been taken into account in computing
deferred taxes, as it is the Company's intention to hold these investments, not
to realize them.
The Company intends to permanently reinvest the amounts of tax exempt income and
does not intend to cause dividend distribution from such income (see note 10a).
Therefore, no deferred taxes have been provided in respect of such tax-exempt
income.
Teva Group might incur additional taxes, not provided for in these financial
statements, if dividends are distributed out of the income of non-Israeli
companies in the Group. Calculation of the unrecognized deferred tax liability
related to those dividends is not practicable.
J. Company shares held by
subsidiaries:
Company shares held by subsidiaries are
presented as a reduction of "shareholders' equity", at their cost to
the subsidiaries, under "cost of Company shares held by subsidiaries".
Gains and losses on sale of these shares, net of related tax, are carried to
"additional paid-in capital".
K. Revenue recognition:
Revenue from the sale of products is recognized
when title passes to customers. Provisions for rebates, returns and allowances
and other price adjustments are estimated and deducted from gross revenues.
L. Research and development expenses:
Research and development expenses are charged to
income as incurred. Government and other funding of research and development is
recognized as a reduction of research and development expenses as the related
costs are incurred, or as the related milestone is met.
M. Advertising:
The Group expenses the costs of advertising as they
are incurred. Advertising expenses for the years ended December 31, 2000, 1999
and 1998 were $ 10.1 million, $ 10.9 million and
$ 10.3 million, respectively.
N. Concentrations of credit risks -
allowance for doubtful accounts:
Concentrations of credit risks - allowance for
doubtful accounts:
Most of the Group's cash and cash equivalents and short-term investments as of
December 31, 2000 and 1999 were deposited with Israeli, U.S. and European banks.
The Company is of the opinion that the credit risk in respect of these balances
is remote.
Most of the Group's sales are made in North America, Europe and Israel, to a
large number of customers. The sales to each of certain three customers
constitute approximately 6 % of total consolidated sales in the years ended
December 31, 2000 and 1999.
In general, the exposure to the concentration of credit risks relating to trade
receivables is limited, due to the relatively large number of customers and
their wide geographic distribution. The Group performs ongoing credit
evaluations of its debtors and generally does not require collateral. Certain
trade receivables are insured under foreign trade risk insurance. An appropriate
allowance for doubtful accounts is included in the accounts. The allowance in
respect of trade receivables amounts to $ 9.5 million and $ 10.3 million at
December 31, 2000 and 1999, respectively, and has been determined for specific
debts doubtful of collection.
O. Derivatives
Foreign currency derivatives are treated as
hedges in the accounts when: (1) the item the Company intends to hedge exposes
it to a risk, (2) the derivative instrument reduces the exposure to risk and is
inversely correlated to the item it is designated to hedge, and (3) it is
designated as a hedge from the outset.
Gains and losses on derivatives that hedge existing assets or liabilities in
currencies other than the functional currency are recognized in income
commensurate with the results from those assets or liabilities. Balances
receivable or payable in respect of foreign exchange derivatives are included in
the balance sheets among other accounts receivable or payable, as appropriate.
Cash flows from foreign exchange derivatives are recognized in the statements of
cash flows under "cash flows provided by operating activities".
The net premiums paid or received in respect of currency options are presented
in the balance sheets under accounts receivable or payable, as appropriate, and
carried to the statements of income under "financial expenses - net".
Foreign currency derivatives entered to reduce the Group's Foreign currency
exposure with respect to anticipated transactions which do not meet the
requirements for applying hedge accounting, are mark to market at each reporting
period, with gains and losses recognized currently in "financial expenses -
net".
P. Cash and cash equivalents:
The Group considers all highly liquid investments,
which include short-term (up to three months) bank deposits that are not
restricted as to withdrawal or use and short-term debentures, the period to
maturity of which did not exceed three months at time of investment, to be cash
equivalents.
Q. Earnings per American Depository
Receipt ("ADR"): ADR
Basic earnings per ADR are computed by dividing
net income by the weighted average number of ADRs/ordinary and ordinary
"A" shares (including special shares exchangeable into ordinary
shares, note 2a(1)) outstanding during the year, net of Company shares held by
subsidiaries, after giving retroactive effect to the distribution of a 100%
stock dividend in February 2000.
Diluted earnings per ADR are computed by dividing net income by the weighted
average number of ADRs/ordinary and ordinary "A" shares (including
special shares) outstanding during the year, net of Company shares held by
subsidiaries, taking into account the potential dilution that could occur upon
(1) the conversion of the convertible senior debentures, using the if-converted
method; and (2) the exercise of options granted under employee stock option
plans, using the treasury stock method.
R. Comprehensive income:
In addition to net income, other comprehensive
income (loss) includes unrealized gains (losses) on securities
available-for-sale and translation gains (losses) of non-dollar currency
financial statements of subsidiaries and associated companies.
S. Recently issued accounting
pronouncement:
FAS No. 133, "Accounting for Derivative
Instruments and Hedging Activities" introduces a new approach to accounting
treatment of these matters. Under FAS 133, derivative financial instruments are
to be included in the balance sheet at their fair value. Any changes in fair
value are to be reflected as current gains or losses or other comprehensive
gains or losses, depending upon whether the derivative is designated as a hedge
and what type of hedging relationship exists.
The Company adopted FAS 133 as of January 1, 2001. The adoption has no material
effect on the Company's results of operation or on its financial position.
T. Reclassifications:
Certain comparative figures have been reclassified
to conform to the current year presentation.
Note2 - Certain Transactions:
A. Acquisitions :
1) Acquisition of Novopharm Ltd.:
In February 2000, the Company signed an agreement to acquire the total
shareholding and control of Novopharm Ltd. ("Novopharm"), a
Canadian-based generic company which also has operations in the United States
and Hungary. Teva also acquired a shareholders' loan of approximately $74
million granted to Novopharm by the vendor (Dan Family Holdings Ltd.), and other
rights of the vendor. In consideration, the vendor was issued 2.1 million
ordinary shares of Teva and 6.3 million special shares that are exchangeable
into ordinary shares of Teva at his discretion a one-to-one ratio. The ordinary
shares and the special shares entitled the holders, assuming full conversion to
approximately 6.2% of Teva's issued and paid capital at the date of issuance.
The value of the shares was determined to be $ 300 million, allocated as $ 226
million for 100% of the share capital of Novopharm and $ 74 million relating to
the above-mentioned loan.
In addition, through December 31, 2000, the Group acquired shares in a
subsidiary of Novopharm from the minority shareholders in this subsidiary, for a
total amount of
$ 12 million.
This transaction is accounted for by the purchase method. The consideration for
the acquisition was attributed to net assets on the basis of fair value of
assets acquired and liabilities assumed on acquisition date.
An amount of $ 34 million out of the cost of acquisition was attributed to
in-process research and development, that was in various stages of development,
had not reached technological feasibility and has no alternative use. This
amount was expensed upon acquisition, in accordance with generally accepted
accounting principles. The amount attributed to in-process research and
development was based on an independent opinion obtained by management using the
income approach. The income approach reflects the present value of the net
operating cash flows generated by such research and development projects, the
relative risk associated with such projects and an appropriate discount rate.
The excess of cost of acquisition over the fair value of net tangible assets on
acquisition date, not attributable to in-process research and development
amounted to $ 326 million, allocated as $ 252 million to goodwill and $ 74
million to other identifiable intangible assets including marketing rights,
product rights and workforce.
Additional purchase liabilities recorded included $ 13.4 million for severance
pay and related costs associated with the shut-down and consolidation of certain
acquired facilities. At December 31, 2000, purchase liabilities of $ 10.1
million in respect of the above were outstanding. Novopharm had terminated the
employment of 103 of the 200 employees whose employment was to be terminated.
Goodwill is amortized over 30 years, using the straight-line method; other
identifiable intangible assets are amortized over 12-30 years, using the
straight-line method. The amount of goodwill is subject to adjustments, mainly
as a result of completion of the consolidation plan and shut down of activities,
which may involve additional liabilities. In addition, the amount of goodwill
could be influenced by the resolution of contingent liabilities pending as of
the acquisition date.
The acquisition of Novopharm became effective at the beginning of April 2000,
and therefore, the operations of Novopharm were consolidated in the consolidated
financial statements of Teva commencing the second quarter of 2000.
2) Acquisition of Copley Pharmaceutical Inc.:
In September 1999, the wholly-owned subsidiary Teva Pharmaceuticals USA, Inc.
("Teva USA") acquired full control and ownership of Copley
Pharmaceutical, Inc. ("Copley"), a U.S. generic pharmaceutical
company, for $ 220 million. The acquisition of Copley was accounted for by the
purchase method. The consideration for the acquisition was attributed to net
assets, on the basis of fair value of the assets acquired and liabilities
assumed on the acquisition date. The results of operations of Copley have been
included in the consolidated financial statements of Teva commencing October 1,
1999.
An amount of $ 17.7 million out of the acquisition price was attributed to the
acquisition of in-process research and development, that was in various stages
of development, had not reached technological feasibility and has no alternative
use. This amount was expensed upon acquisition, in accordance with generally
accepted accounting principles. The amount attributed to in-process research and
development was based on an independent opinion obtained by management, using
the income approach (see (1) above). The excess of cost of acquisition over the
fair value of net tangible assets on acquisition date, not attributed to
in-process research and development (after adjustment in 2000) - $ 117 million -
is presented as goodwill and is being amortized over 30 years using the
straight-line method.
Additional purchase liabilities recorded included approximately $ 8.4 million
for severance and related costs associated with the shut-down and consolidation
of certain acquired facilities. At December 31, 2000 liabilities of
approximately $ 2.2 million in severance and facility related costs remained on
the balance sheet. The Company had terminated 219 of the 250 employees whose
employment was to be terminated. The Company expects to complete its termination
of employees and consolidation of facilities in 2001.
3) Certain pro forma data
Hereafter are certain unaudited pro forma combined statements of income data for
the years ended December 31, 2000 and 1999, as if the acquisition of Novopharm
and Copley occurred on January 1, 1999, after giving effect to purchase
accounting adjustments, including amortization of goodwill and other
identifiable intangible assets, the elimination of intercompany transactions and
profits not yet realized outside the Group, the effect of additional financing
obtained to complete the Copley acquisition, but excluding non-recurring charges
directly attributable to the acquisitions (acquired in-process research and
development, in the amount of $ 34.4 million and $ 17.7 million, in 2000 and
1999, respectively). The pro forma financial information is not necessarily
indicative of the combined results that would have been attained had the
acquisitions taken place at the beginning of 1999, nor is it necessarily
indicative of future results.
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Year ended December 31
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2000
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1999
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U.S. $ in thousands (Unaudited)
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Sales
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$ 1,830,696
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$ 1,724,909
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Net income
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$ 172,559
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$ 99,897
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Earnings per ADR:
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Basic
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$ 1.32 $
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$ 0.76
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Diluted
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$ 1.30 $
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$ 0.76
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4) Acquisition of the Pharmachemie N.V. group:
On July 1, 1998, the Company acquired full ownership and control of Pharmachemie
N.V., a Dutch generic pharmaceutical company, and companies related thereto
("Pharmachemie") for approximately $ 83 million. The goodwill arising
upon acquisition, (after adjustment in 1999), aggregated $ 89.7 million and is
being amortized over 40 years, using the straight-line method. The acquisition
of Pharmachemie was accounted for by the purchase method. The operations of
Pharmachemie were included in the consolidated financial statements of Teva from
the date of acquisition.
B. Cooperation agreements:
1) With Aventis:
a) Through December 31, 2000, the marketing, sale and distribution of CopaxoneŽ,
an innovative product of the Company for the treatment of multiple scelerosis,
in North America have been carried out pursuant to several agreements entered
into by Teva and Aventis Pharmaceuticals, Inc. ("Aventis"). These
agreements were amended (and in the case of one agreement, terminated) by the
U.S. Restructuring Agreement entered into, subsequent to December 31, 2000, by
Teva and Aventis.
b) Under a separate agreement between the Company and the German parent company of Aventis, Aventis distributes and sells CopaxoneŽ in Europe and certain other countries. In the core European countries, CopaxoneŽ is to be jointly marketed by Teva and Aventis.
Upon receipt of approvals for CopaxoneŽ in certain European countries, as stipulated by the agreement, certain amounts will become due from Aventis.
In 2000, an approval for CopaxoneŽ was granted in the U.K. and, as a result, an amount of $ 5 million became due. Such amount, less the portion due to the relevant research institute, is deducted from research and development expenses under "grants and participations". Upon receipt of additional approvals an amount of up to $ 10 million will become due from Aventis, portion of which will be payable to the relevant research institute.
The above agreement with the German parent of Aventis was also amended by another restructuring agreement entered into by the parties, subsequent to December 31, 2000. Under this restructuring agreement, under certain conditions, Teva has reserved the right to reacquire the marketing and distribution rights in Europe to the injectible formulation of CopaxoneŽ for consideration to be computed based on a certain formula, as stipulated in the agreement.
2) With Lundbeck:
a) In November 1999, the Company entered into a cooperation agreement with a Danish company, H. Lundbeck A/S ("Lundbeck"), for the joint global development and for the marketing, mainly in Europe, of two innovative products of the Company for the treatment of Parkinson's disease. The exclusive marketing rights for the rest of the world will remain in the hands of the Company. Under the agreement, commencing in 1999, Lundbeck participates in the research and development expenses of Teva at varying rates, subject to maximum amounts stipulated in the agreement. The amounts received during 1999 and 2000 are included among "research and development expenses - grants and participations".
b) Teva and Lundbeck have entered into an additional cooperation agreement, for the global development and for the marketing, mainly in Europe, of the oral version of CopaxoneŽ. Under the agreement, Lundbeck is to fund the research and development of the product by Teva, up to a maximum amount stipulated in the agreement. Other provisions of the agreement relate to the additional funding by Lundbeck of certain other development, pre-marketing and marketing activities relating to the product. Such additional funding is to be made under certain conditions and up to a maximum amount, as stipulated in the agreement.
3) With BTG:
Pursuant to an agreement, effective September 30, 1999, between the Company and Bio Technology General Corp. ("BTG") Teva is to make payments of up to $ 20 million to BTG relating to certain biotech products. Through December 31, 2000 an amount of $ 12.5 million was paid, of which $ 10 million relates to certain marketing and distribution rights are to become effective no later than 2003 and is included among intangible assets. The remaining amount of $ 2.5 million represents participation in development expenses of BTG relating to certain products under research and development and was charged in the year ended December 31, 2000, to research and development expenses. The balance is to be paid on fulfillment of certain conditions, as per the agreement.
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