(Source: Business Wire)

Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) today reported results
for the quarter ended September 30, 2009.
Third Quarter Highlights:
Net sales of $3.55 billion, up 25% compared to the third quarter of
2008.
Non-GAAP net income of $806 million, up 28% compared with the third
quarter of 2008. GAAP net income totaled $649 million compared with
$631 million in the comparable quarter in 2008.
Non-GAAP diluted EPS of $0.89, up 16% compared with the third quarter
of 2008. GAAP diluted EPS totaled $0.72, compared with $0.77 in the
comparable quarter in 2008.
Non-GAAP operating income of $997 million, up 42% compared to the
third quarter of 2008. GAAP operating income totaled $753 million,
compared with $622 million in the comparable quarter in 2008.
Record global in-market sales of Copaxone® of $776 million,
up 38% compared to the third quarter of 2008. Copaxone®
continues to be the leading MS therapy in the U.S. and globally.
Record quarterly cash flow from operations of $1,025 million.
"This was another very strong quarter for Teva, with record-breaking
financial results across the board," commented Shlomo Yanai,
Teva's President and Chief Executive Officer. "In fact, for the
first time, we crossed the billion dollar mark in quarterly cash flow
from operations. All of our business units and geographies continued to
grow during the quarter, with especially strong sales of Copaxone®,
which continued to strengthen its position as the world's leading
therapy for the treatment of multiple sclerosis, and of ProAir,
the leading Albuterol inhaler in the U.S."
Mr. Yanai continued: "This is the time of year when we develop our
workplan and update our strategy for the next few years. The process
this year is an especially inspiring one, as the more closely we analyze
the opportunities ahead, the more excited we become about Teva's
futurewhich, in both the near and long-term, looks very bright."
Net sales for the quarter increased 25% to $3,550 million,
compared to $2,842 million in the third quarter of 2008. The acquisition
of Barr contributed to the growth in sales in all of Teva's geographies,
particularly in the U.S., Russia, Poland, Germany, and Croatia.
Exchange rate differences negatively impacted sales in the third
quarter of 2009 by approximately $160 million, or 6%, as compared to the
third quarter of 2008. The negative impact on sales resulted primarily
from the strengthening of the U.S. Dollar relative to the Hungarian
Forint, Russian Ruble, Euro, British Pound, Polish Zloty and Israeli
Shekel in the third quarter of 2009 compared with the comparable quarter
in 2008. Foreign currency differences between the third quarter of 2009
and the third quarter of 2008 adversely affected operating profit by
approximately $25 million. The negative impact on operating profit
resulted primarily from the strengthening of the U.S. Dollar relative to
the Russian Ruble, British Pound and Polish Zloty, where we have higher
sales than expenses, partially offset by modest devaluation of the
Israeli Shekel against the U.S. Dollar, where we have higher expenses
than sales.
Non-GAAP net income for the third quarter of 2009 totaled
$806million, an increase of 28%, while non-GAAP diluted earnings
per share were $0.89, an increase of 16% compared to the comparable
quarter in 2008. The share count used for the fully diluted earnings per
share for the third quarter of 2009 increased by approximately 78
million shares compared to that of the third quarter of 2008 due,
primarily, to the shares issued in connection with the acquisition of
Barr. On a U.S. GAAP basis, net income for the third quarter totaled
$649million compared with $631 million in the third quarter of 2008,
while diluted earnings per share were $0.72, compared with $0.77 in the
third quarter of 2008.
Non-GAAP net income and non-GAAP EPS for the third quarter of 2009 are
adjusted to exclude the following items:
Amortization of purchased intangible assets and inventory step up of
$147 million;
Restructuring charges of $47 million;
Impairment of assets of $37 million;
Legal settlements of $13 million; and
A related tax benefit of $87 million.
Teva believes that excluding these items facilitates investors'
understanding of the trends in the Company's underlying business. In the
third quarter of 2008, non-GAAP net income and non-GAAP EPS excluded a
settlement payment from an institution in connection with our auction
rate securities portfolio, offset by amortization of purchased
intangible assets, acquisition of in process R&D, impairment of
financial assets, inventory step-up, and a related tax effect. See the
attached table for a reconciliation of U.S. GAAP reported results to the
adjusted non-GAAP figures.
Non-GAAP operating income (which excludes the amortization of
purchased intangible assets and inventory step up, restructuring
charges, impairment of assets and legal settlements, as detailed above)
increased 42% to $997million, compared with the third quarter of 2008.
On a U.S. GAAP basis, operating income totaled $753 million, up 21%
compared with the third quarter last year.
Pharmaceutical sales in North America for the third quarter
reached $2,164million, accounting for 63% of total pharmaceutical sales
and representing an increase of 34% compared with the third quarter of
last year. Quarterly sales benefited from the launch of generic versions
of Ortho Tri-Cyclen®Lo (norgestimate/ethinyl estradiol) and
Eloxatin® (oxaliplatin) in the quarter, as well as continued
strong sales of generic versions of Lotrel® (amlodipine
benazapril), Adderall XR® (amphetamine salts), Yasmin®
(drospirenone and ethinyl estradiol), and Protonix®
(pantoprazole) launched in previous quarters. The quarter's sales also
reflected continued strong sales of Copaxone® and ProAir.
As of October 23, 2009, Teva had 210 product applications awaiting final
FDA approval, including 40 tentative approvals. Collectively, the brand
products covered by these applications had annual U.S. sales of over
$113billion. Of these applications, 136 were "Paragraph IV"
applications challenging patents of branded products. Teva believes it
is the first to file on 83 of the 136 applications, relating to products
with annual U.S. branded sales exceeding $54 billion.
Pharmaceutical sales in Europe in the third quarter of 2009
totaled $787million, accounting for 23% of total pharmaceutical sales,
and representing an increase of 15% compared with the third quarter of
last year. In local currencies, sales in Europe grew 28% compared with
the third quarter of 2008. The 28% growth in sales in local currencies
was mostly attributable to strong generic sales in Germany, Spain and
Poland.
Since the beginning of the year, Teva has received 880 generic approvals
in Europe relating to 149 compounds in 313 formulations, including 7
EMEA approvals valid in all EU member states. In addition, as of
September 30, 2009, Teva had 3,058 marketing authorization applications
pending approval in 30 European countries, relating to 242 compounds in
508 formulations, including 14 applications pending with the EMEA.
International pharmaceutical sales in the third quarter of 2009
totaled $463 million, accounting for 14% of total
pharmaceutical sales and representing an increase of 17% compared to the
third quarter of 2008. In local currencies, international sales grew 33%
compared with the third quarter of 2008. The 33% sales growth in
international markets in local currencies was driven by increased sales
in Russia, Croatia and Israel as well as in certain countries in Latin
America.
Copaxone® continued to lead as the number one
MS therapy in the U.S. and globally, with approximately 30% market
share. Record in-market sales reached $776million in the third quarter
of 2009, an increase of 38% over the third quarter of 2008. In the U.S.,
in-market sales increased 53% to reach $540 million compared to the
third quarter of 2008. In-market sales outside the U.S. totaled $236
million, up 12% compared to the third quarter of 2008. In local
currencies, in-market sales of Copaxone® outside the U.S.
grew 23%.
Global in-market sales of Azilect® reached $64
million in the quarter, a 39% increase over the comparable period in
2008. In local currencies, global in-market sales of Azilect®
grew 45%. In the third quarter of 2009, Azilect®
continued to increase its market share in the major European markets and
the U.S.
Teva's global respiratory business reached sales of $243 million,
up 37% compared to $177million in the third quarter of 2008. The
increase is attributable primarily to strong ProAir sales in
the U.S. Teva's respiratory sales in the U.S. totaled $166 million, up
66% compared to the comparable quarter in 2008. In the third quarter,
Teva maintained its market leadership position with a 56% market share
in the SABA (short acting beta agonist) market in the U.S.
Teva's women's health business, which was acquired as part of the
Barr acquisition, reached sales of $103 million, an increase of 10% from
$94 million sold by Barr in the comparable quarter in 2008. The increase
in sales is attributable primarily to an increase in the sales of PlanB®.
These sales figures represent proprietary women's health products only
and are different from the figures previously reported by Barr as its
proprietary sales.
API sales to third parties totaled $136 million in the third
quarter, down $12 million compared to the comparable quarter last year.
Non-GAAP gross profit margin reached 58.2% in the third
quarter of 2009, compared to the 54.0% non-GAAP gross profit margin
recorded in the comparable quarter of 2008. The improvement in non-GAAP
gross profit margins reflects higher contributions as a percentage of
sales of innovative and branded products, including Copaxone®,
ProAir, Azilect® and women's health
products, as well as improved gross margins of the U.S. generics base
business. GAAP gross profit margin increased to 54.3% in the third
quarter of 2009, compared with GAAP gross profit of 52.5% in the
comparable quarter of 2008.
Net Research & Development (R&D) expenditures totaled
$195million, or 5.5% of sales, compared to $194million recorded in the
third quarter of 2008, or 6.8% of sales. During the quarter, TL
Biopharmaceuticals AG, Teva's joint venture with Lonza Group Ltd.,
reimbursed Teva $8million for certain R&D expenses. Teva continues to
invest in R&D in accordance with its strategic plan to double generic
R&D output from its 2007 level by 2012, as well as to expand R&D
activity in biogenerics and its innovative and branded franchises.
Selling and Marketing (S&M) expenditures (excluding
amortization of purchased intangible assets) totaled $662million, or
18.6% of sales, for the third quarter, compared to $485 million, or
17.1% of sales, in the comparable quarter of 2008. The increase in S&M
expenses is attributable to two main factors: the addition of Barr's
business which is characterized by higher S&M expenses; and higher
royalty payments resulting from higher Coapxone®
revenues.
General and Administrative (G&A) expenditures totaled $212
million, or 6.0% of sales, for the third quarter, compared with $156
million, or 5.5% of sales, in the comparable quarter of 2008.
The non-GAAP tax expense provided for in the third quarter is
$136 million, compared with $52 million in the third quarter of 2008.
Teva's current estimate of the annual tax rate for 2009 is 16% compared
to a rate of 10% of pre-tax non-GAAP income for 2008. The increase in
tax rate from 2008 to 2009 results primarily from the consolidation of
Barr's results. On a GAAP basis, the annual tax rate is estimated to be
approximately 10%.
Cash flow generated from operating activities during the third
quarter of 2009 was $1,025million, compared to $710 million in the
comparable quarter in 2008. Free cash flow -- excluding net capital
expenditures (of $195 million) and dividends (of $126 million) -- reached
$704 million. Cash and marketable securities as of September 30, 2009
were $2.0 billion. During the quarter, Teva used approximately $800
million to reduce, primarily, short term debt. This amount includes the
remaining balance of the bridge financing incurred in connection with
the acquisition of Barr.
Shareholders equity on September 30, 2009 amounted to $19.3
billion, an increase of $2.9billion compared to $16.4 billion as of
December 31, 2008. The increase in shareholders equity is attributable
to net income of $1.6 billion recorded in the first nine months of 2009,
the conversion of $887 million of convertible debt ($719 million in the
second quarter and an additional $168 million in the current quarter),
and a positive adjustment of $603million recorded in connection with
the translation of non-U.S. Dollar net assets, offset mainly by
dividends paid in the amount of $387million.
For the third quarter of 2009, the weighted average share count
for the fully diluted earnings per share calculation was 915 million
shares on both a GAAP and non-GAAP basis. As of September 30, 2009,
Teva's share count going forward for the fully diluted share calculation
is estimated at 916 million shares, while the share count for
calculating Teva's market capitalization is approximately 886 million
shares.
Dividend
The Board of Directors, at its meeting on November 2, 2009, declared a
cash dividend for the third quarter of 2009 of NIS 0.60 (approximately
15.9cents according to the rate of exchange on November 2, 2009) per
share.
The record date will be November 11, 2009, and the payment date will be
November 26, 2009. Tax will be withheld at a rate of 20%.
Conference Call
Teva will host a conference call to discuss the Company's third quarter
results, on Tuesday, November 3, 2009 at 8:30 a.m. ET. The call will be
webcast and can be accessed through the Company's website at www.tevapharm.com.
Following the conclusion of the call, a replay of the webcast will be
available within 24 hours at the Company's website. A replay of the call
will also be available until November 10, 2009, at 11:59 p.m. ET, by
calling 201-612-7415 outside the United States or 877-660-6853 in the
United States. The pass code to access the replay is: Account # 3055 and
Conference ID# 335185.
About Teva
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among
the top 20 pharmaceutical companies in the world and is the world's
leading generic pharmaceutical company. The Company develops,
manufactures and markets generic and innovative human pharmaceuticals
and active pharmaceutical ingredients, as well as animal health
pharmaceutical products. Over 80 percent of Teva's sales are in North
America and Europe.
Teva's Safe Harbor Statement under the U. S. Private Securities
Litigation Reform Act of 1995:
This release contains forward-looking statements, which express the
current beliefs and expectations of management. Such statements are
based on management's current beliefs and expectations and involve a
number of known and unknown risks and uncertainties that could cause our
future results, performance or achievements to differ significantly from
the results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to: our ability to
successfully develop and commercialize additional pharmaceutical
products, the introduction of competing generic equivalents, the extent
to which we may obtain U.S. market exclusivity for certain of our new
generic products and regulatory changes that may prevent us from
utilizing exclusivity periods, potential liability for sales of generic
products prior to a final resolution of outstanding patent litigation,
including that relating to the generic versions of Neurontin®, Lotrel®,
Protonix® and Eloxatin®, the current economic conditions, competition
from brand-name companies that are under increased pressure to counter
generic products, or competitors that seek to delay the introduction of
generic products, the effects of competition on our innovative products,
especially Copaxone® sales, dependence on the effectiveness of our
patents and other protections for innovative products, the impact of
consolidation of our distributors and customers, the impact of
pharmaceutical industry regulation and pending legislation that could
affect the pharmaceutical industry, our ability to achieve expected
results through our innovative R&D efforts, the difficulty of predicting
U.S. Food and Drug Administration, European Medicines Agency and other
regulatory authority approvals, the uncertainty surrounding the
legislative and regulatory pathway for the registration and approval of
biotechnology-based products, the regulatory environment and changes in
the health policies and structures of various countries, supply
interruptions or delays that could result from the complex manufacturing
of our products and our global supply chain, our ability to successfully
identify, consummate and integrate acquisitions, the potential exposure
to product liability claims to the extent not covered by insurance, our
exposure to fluctuations in currency, exchange and interest rates,
significant operations worldwide that may be adversely affected by
terrorism, political or economical instability or major hostilities, our
ability to enter into patent litigation settlements and the intensified
scrutiny by the U.S. government, the termination or expiration of
governmental programs and tax benefits, impairment of intangible assets
and goodwill, environmental risks, and other factors that are discussed
in this report and in our other filings with the U.S. Securities and
Exchange Commission ("SEC").
Teva Pharmaceutical Industries Limited
Consolidated Statements of Income
(Unaudited, U.S.