Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) provides its
current outlook for non-GAAP financial performance for the full
year ending December 31, 2014.
In an effort to enhance investor understanding of the business
performance of the company, and to provide more clarity and
transparency regarding its projections for 2014, given the
significant uncertainty concerning possible generic competition to
Copaxone® in the U.S., the Company is providing two alternative
scenarios for its current non-GAAP financial outlook for the
year:
- the "Generic Copaxone" scenario
assumes the launch of at least two AP-rated generic competitors to
Copaxone® in the U.S. on June 1, 2014; and
- the "Exclusive Copaxone"
scenario assumes no generic competition to Copaxone® in the U.S.
during 2014.
Both scenarios assume the launch of Copaxone® 40mg
three-times-a-week in early 2014 and exclusive sales of the generic
version of Pulmicort® in the U.S. throughout 2014. The outlook
provided is organic, and neither alternative includes the potential
impact of any business development activities.
Below is a table summarizing the non-GAAP financial outlook for
the two scenarios:
Generic Exclusive Copaxone
Copaxone Net Revenues ($ b) 19.3-20.3 19.8-20.8 GP (%)
57%-59% 58%-60% R&D ($ b) 1.3-1.45 1.3-1.45 S&M ($ b)
4.0-4.1 4.0-4.1 G&A ($ b) 1.2 1.2 OP ($ b) 4.8-5.1 5.35-5.65
Finance Expenses ($ m) 310-350 310-350 Tax (%) 20%-21%
19%-20% Number of Shares (m) 840-850 840-850
EPS ($)
4.20-4.50 4.80-5.10 Cash Flow from Operations
($ b)
2.7
3.0
Teva estimates that each month of delay in the launch of generic
competitors to Copaxone® in the U.S. will contribute on average
approximately $78 million to net revenues and $0.08 to non-GAAP
diluted earnings per share.
“2014 will be a pivotal year for Teva and a year of major
transitions across the company", stated Eyal Desheh, Acting
President and CEO of Teva. "We will continue to make
significant progress in implementing our strategy. We will focus
our efforts on our generics business and core R&D programs,
including high-value complex generics, promising specialty
medicines and New Therapeutic Entities. In our specialty business,
we anticipate six important launches and the potential submission
of ten additional medicines for approval. At the same time, we are
focused on increasing our organizational effectiveness through our
cost reduction program to ensure Teva’s leadership position, growth
and sustainable profitability.”
Detailed financial outlook:
Generic Exclusive
Copaxone Copaxone U.S. $ in billions Generics
inc. API 9.8 - 10.5 9.8 - 10.5 Specialty: 7.3 - 7.7 7.8 - 8.2 OTC
& Other*: 2.0 - 2.2 2.0 - 2.2 Total Net Revenues 19.3 - 20.3
19.8 - 20.8
*Including OTC, distribution & other
- Net Revenues by
Geographies:
Generic Exclusive
Copaxone Copaxone U.S. $ in billions United
States 9.5-9.9 10.0-10.4 Europe*: 5.7-6.2 5.7-6.2 Rest of the
World: 3.8-4.2 3.8-4.2 Total Net Revenues 19.3 - 20.3 19.8 - 20.8
*All members of the European Union, Switzerland, Norway and
certain South Eastern Europe countries
- Generics (including API) Net
Revenues:
U.S. $ in billions United States 4.1 - 4.5 Europe*:
3.1 - 3.5 Rest of the World: 2.3 - 2.6 Total Generics Net Revenues
9.8 - 10.5
*All members of the European Union, Switzerland, Norway and
certain South Eastern Europe countries
- Key Specialty Medicines Net
Revenues:*All members of the European Union, Switzerland,
Norway and certain South Eastern Europe countries
Generic Exclusive Copaxone
Copaxone U.S. $ in millions Copaxone®
3,100-3,200 3,600-3,700 Treanda® 750 ProAir® 510 Azilect® 390 Qvar®
380 Nuvigil® 350
- Other net revenues of $2.0-$2.2
billion, which include net revenues from Teva's share in PGT
Healthcare, our joint venture with Procter & Gamble, of
$1.0-1.1 billion, and approximately $0.2 billion of OTC contract
manufacturing in the U.S.Overall in-market revenues of PGT
Healthcare will be approximately $1.7 billion. This amount
represents sales of the combined OTC portfolios of Teva and P&G
outside of North America.
Other Generic
Exclusive OTC & Generics
Specialty Copaxone Copaxone
Other Total Revenues ($ b) 9.8-10.5 4.2-4.5 3.1-3.2
3.6-3.7 2.0-2.2 GP (%) 41%-44% 83%-85% 88%-91% 88%-91% 32%-34%
R&D ($ b) 0.45-0.50 0.8-0.9 0.1 0.1 - Total S&M ($ b)
1.7-1.8 1.4 0.6-0.7 0.6-0.7 0.3 OP before G&A ($ b) 2.0-2.3
1.15-1.55 2.0-2.1 2.55-2.65 0.35-0.5 % of Teva Total OP before
G&A* 33% 21% - 39% 7%
* Mid-range compared to "Exclusive Copaxone" scenario
(approximate)
Non-GAAP gross profit margin excludes amortization of intangible
assets of approximately $1.1 billion.
Non-GAAP selling & marketing expenses exclude amortization
of intangible assets.
Non-GAAP total expenses are exclusive of approximately $900
million of restructuring expenses due to cost reduction
programs
- Figures for Cash flow from
operations are after deduction of payments of approximately $2
billion in 2014 for legal settlements and payments related to our
cost reduction program.
Note: items not expressed in
this press release in the form of ranges are approximate and may
vary +/-5%.
These estimates reflect management`s current expectations for
Teva's performance in 2014. Actual results may vary, whether as a
result of FX differences, market conditions or other factors. In
addition, the non-GAAP figures exclude the amortization of
purchased intangible assets, costs related to certain regulatory
actions, inventory step-up, legal settlements and reserves,
impairments and related tax effects. The non-GAAP data presented by
Teva are the results used by Teva's management and board of
directors to evaluate the operational performance of the company,
to compare against the company's work plans and budgets, and
ultimately to evaluate the performance of management. Teva provides
such non-GAAP data to investors as supplemental data and not in
substitution or replacement for GAAP results, because management
believes such data provides useful information to investors.
Conference Call
Teva will host a conference call and live webcast to discuss its
2014 business outlook on Tuesday, December 10, 2013,
at 8:00 a.m. Eastern Daylight Time. The call will be webcast
and can be accessed through the Company's website
at www.tevapharm.com, or by dialing 1-800-510-9691 (U.S.
and Canada) or 1-617-614-3453 (International). The conference
ID is 15601679. Following the conclusion of the call, a replay will
be available within 24 hours at the Company's website
at www.tevapharm.com. A replay will also be available
until December 17, 2013, at 11:59 p.m. ET, by calling
1-888-286-8010 (U.S. and Canada) or 1-617-801-6888
(International). The Conference ID is 73093491#.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading
global pharmaceutical company, committed to increasing access to
high-quality healthcare by developing, producing and marketing
affordable generic drugs as well as innovative and specialty
pharmaceuticals and active pharmaceutical ingredients.
Headquartered in Israel, Teva is the world's leading generic drug
maker, with a global product portfolio of more than 1,000 molecules
and a direct presence in about 60 countries. Teva's branded
businesses focus on CNS, oncology, pain, respiratory and women's
health therapeutic areas as well as biologics. Teva currently
employs approximately 46,000 people around the world and reached
$20.3 billion in net revenues in 2012.
Teva's Safe Harbor Statement under the U. S. Private
Securities Litigation Reform Act of 1995:This document contains
forward-looking statements, which express the current beliefs and
expectations of management. Such statements 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:
the ability to reduce operating expenses to the extent and during
the timeframe intended by our cost restructuring program; our
ability to develop and commercialize additional pharmaceutical
products, including our ability to develop, manufacture, market and
sell biopharmaceutical products, competition for our innovative
medicines, especially COPAXONE® (including competition from
innovative orally-administered alternatives, as well as from
potential purported generic equivalents), competition for our
generic products (including from other pharmaceutical companies and
as a result of increased governmental pricing pressures),
competition for our specialty pharmaceutical businesses, our
ability to achieve expected results through our specialty,
including innovative, R&D efforts, the effectiveness of our
patents and other protections for innovative products, decreasing
opportunities to obtain U.S. market exclusivity for significant new
generic products, our ability to identify, consummate and
successfully integrate acquisitions and license products,
uncertainties relating to the replacement of and transition to a
new President & Chief Executive Officer, the effects of
increased leverage as a result of recent acquisitions, the extent
to which any manufacturing or quality control problems damage our
reputation for high quality production and require costly
remediation, our potential exposure to product liability claims to
the extent not covered by insurance, increased government scrutiny
in both the U.S. and Europe of our settlement agreements with brand
companies and liabilities arising from class action litigation and
other third-party claims relating to such agreements, potential
liability for sales of generic medicines prior to a final
resolution of outstanding patent litigation, our exposure to
currency fluctuations and restrictions as well as credit risks, the
effects of reforms in healthcare regulation and pharmaceutical
pricing and reimbursement, any failures to comply with complex
Medicare and Medicaid reporting and payment obligations,
governmental investigations into sales and marketing practices,
particularly for our specialty medicines (and our ongoing FCPA
investigations and related matters), uncertainties surrounding the
legislative and regulatory pathways for the registration and
approval of biotechnology-based medicines, adverse effects of
political or economical instability, corruption, major hostilities
or acts of terrorism on our significant worldwide operations,
interruptions in our supply chain or problems with our information
technology systems that adversely affect our complex manufacturing
processes, any failure to retain key personnel or to attract
additional executive and managerial talent, the impact of
continuing consolidation of our distributors and customers,
variations in patent laws that may adversely affect our ability to
manufacture our products in the most efficient manner, potentially
significant impairments of intangible assets and goodwill,
potential increases in tax liabilities resulting from challenges to
our intercompany arrangements, the termination or expiration of
governmental programs or tax benefits, environmental risks and
other factors that are discussed in our Annual Report on Form 20-F
for the year ended December 31, 2012 and in our other filings with
the U.S. Securities and Exchange Commission. Forward-looking
statements speak only as of the date on which they are made and the
Company undertakes no obligation to update or revise any forward
looking statement, whether as a result of new information, future
events or otherwise.
Teva Pharmaceutical Industries Ltd.IR:Kevin C. Mannix,
215-591-8912United StatesorRan Meir, 215-591-3033United
StatesorTomer Amitai, 972 (3) 926-7656IsraelorPRIris Beck
Codner, 972 (3) 926-7246IsraelorDenise Bradley,
215-591-8974United States
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