Novartis highlights growth prospects driven by significant R&D pipeline progress and the expected increase in blockbuster treatments
(Thomson Reuters ONE) -
Novartis International AG /
Novartis highlights growth prospects driven by significant R&D pipeline progress
and the expected increase in blockbuster treatments
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The issuer is solely responsible for the content of this announcement.
* Novartis takes action to strengthen portfolio and capital allocation, starts
share buyback
* Blood transfusion diagnostics unit divested as part of ongoing portfolio
management
* Reiterates optimal capital structure with a target rating of double-A
* Share buyback of USD 5 billion to start immediately and be executed over
two years
* Pharmaceuticals entering a new growth phase, driven by productive R&D engine
* New business segments being developed in Dermatology, Heart Failure,
Respiratory and Cell Therapy to complement already successful Oncology
business
* AIN457 regulatory application for psoriasis submitted in US and EU
* Oncology business on track to grow year-on-year through Glivec patent expiry
* Innovation focused on targeted and cellular therapies as next frontier
of cancer treatment
* Pipeline includes 24 ongoing pivotal trials exploring 16 new products
and indications
* LEE011 in combination with letrozole advanced to Phase III in breast
cancer
* Alcon expected to deliver above-market growth
* Surgical franchise expected to lead performance, due to new launches
including the next-generation cataract refractive suite
Basel, November 22, 2013 - Novartis today announced the launch of a USD 5
billion share buyback, reflecting the company's confidence in its long-term
growth prospects, as well as its commitment to deliver strong shareholder
returns. The buyback will start immediately and be executed over two years on
the 2nd trading line.[*]
"Novartis has reached an inflection point, having fully integrated Alcon and
reduced debt," said Joseph Jimenez, CEO of Novartis. "We are now further
sharpening the execution of our strategy to strengthen shareholder value through
science-based innovation in high-growth segments of healthcare where we have the
global scale, competitive advantage and the right capabilities to win."
Novartis recently announced a definitive agreement to divest its blood
transfusion diagnostics unit to Grifols for USD 1.7 billion. The sale enables
Novartis to focus more sharply on its strategic businesses and is one result of
the ongoing review of the diversified portfolio.
Novartis continues to focus on delivering shareholder returns in 2014 and 2015
Novartis re-confirms its capital structure aligned with a target rating of
double-A as a reflection of the company's financial strength and discipline.
Within this target rating, Novartis will allocate capital to a strong and
growing dividend, value-creating bolt-on acquisitions and a USD 5 billion share
buyback starting immediately, which reflects confidence in the company's growth
prospects.
Novartis also announces it will continue to pursue an aggressive productivity
agenda, which has offset generic erosion and growth investments over the past
two years. Ongoing initiatives include leveraging scale in Procurement,
consolidating Research sites around the world and optimizing the manufacturing
footprint. These programs are expected to deliver approximately 3-4% of sales in
productivity gains per year through 2015, and contribute to organic margin
leverage.
Pharmaceuticals entering a new growth phase, driven by productive R&D engine
Pharmaceuticals, the largest division in the Novartis portfolio is preparing for
a new growth phase, driven by an expanding blockbuster portfolio and an
industry-leading pipeline. In addition to products with blockbuster status such
as Lucentis, Gilenya, Afinitor and Tasigna, the Galvus group is expected to
reach more than USD 1 billion in net sales by year end and there is the
potential for a total of 14 or more blockbusters by 2018.
Novartis' productive R&D engine is reflected by the expanding blockbuster
portfolio and, additionally, three FDA Breakthrough Therapy designations in
2013. This year, the company is thoroughly reviewing its assets, and has
prioritized its development portfolio and established new platforms in areas
where it sees significant potential for future sales growth - including
Dermatology, Heart Failure, Respiratory and Cell Therapy - to complement the
already successful Oncology business.
In Respiratory, for example, our comprehensive portfolio of products, Onbrez,
Seebri and Ultibro, delivered through the Breezhaler inhalation device has the
potential to address a large COPD population. Ultibro has recently been launched
in Germany, the Netherlands and Japan.
In Dermatology, Pharmaceuticals has promising products under development
including AIN457 (secukinumab). A regulatory application for the use of AIN457
for moderate-to-severe plaque psoriasis was submitted in the US and EU in
October.
Oncology on track to grow every year through Glivec patent expiry
Within Pharmaceuticals, Novartis Oncology has continued to transform and
rejuvenate its portfolio, and is on track to grow every year in the next five
years despite loss of exclusivity for Glivec.
The Oncology pipeline includes an industry-leading 24 ongoing pivotal trials
exploring 16 new products and indications. This acceleration of the development
process is expected to lead to more approvals and sales by 2017 than previously
projected. Expected news flow through 2015 includes results from 11 pivotal
studies, including data on LDK378, an FDA Breakthrough Therapy, in ALK+ non-
small cell lung cancer pre-treated with chemotherapy and crizotinib.
Innovation power focused on targeted and cellular therapies for cancer
Novartis' broad Oncology portfolio places the company at a strategic advantage
in developing targeted and cellular therapies, as it provides access to single
agents and unique proprietary combinations that can target specific tumor
mutations and potentially overcome resistance mechanisms. For example, in 2013,
Novartis initiated multiple combination studies containing LEE011, BKM120,
BYL719, LGX818 or MEK162 including the initiation of a Phase III trial in
December in breast cancer for LEE011 in combination with letrozole.
In addition, Oncology's groundbreaking chimeric antigen receptor technology
(CART) platform, which now has multiple programs in various stages of
development, bridges targeted therapies and immunotherapy with the potential to
revolutionize cancer treatment. CTL019, in particular, has shown promise in
chronic lymphocytic leukemia and acute B-cell lymphocytic leukemia patients, and
is being investigated in additional CARTs.
Alcon expected to deliver above-market growth
Since the merger in 2011, Alcon has been integrated into the Novartis Group and
achieved cost synergies of USD 370 million. The division is now positioned to
deliver above-market growth in the mid to high-single digits in constant
currencies, due to Alcon's broad portfolio of new and innovative products
addressing significant patient need.
Surgical is growing the fastest, and is expected to benefit from the launch of
its next-generation cataract refractive suite including Centurion, which has the
potential to transform refractive outcomes for cataract patients. In Ophthalmic
Pharmaceuticals, loss of exclusivity on some brands is expected to have a near-
term impact, with products such as Jetrea and Simbrinza presenting opportunities
for mid-term growth. Vision Care, with the launch of Dailies Total1, is well-
positioned with a broad innovative portfolio in contact lenses.
A winning strategy for shareholders
Novartis maintains a consistent emphasis on innovation, growth and productivity
across its diversified healthcare portfolio as part of its long-term strategy.
Now, with greater clarity around its capital structure and allocation
priorities, sharpened focus on actively managing the portfolio, and capturing
synergies across divisions, Novartis' strategy is aligned with shareholder
interests.
Disclaimer
This press release contains forward-looking statements that can be identified by
terminology such as "prospects," "pipeline," "expected," "ongoing," "target,"
"to start," "be executed," "entering," "being developed," "on track," "next
frontier," "launches," "exploring," "launch," "confidence," "commitment,"
"will," "strategy," "strategic," "continues," "Breakthrough Therapy,"
"potential," "potentially," "promise," "is being investigated," "positioned,"
"opportunities," or similar expressions, or by express or implied discussions
regarding potential new products, potential new indications for existing
products, or regarding potential future revenues from any such products; the
potential completion of the divestiture of the Novartis blood transfusion
diagnostics unit; potential shareholder returns or credit ratings, the potential
outcome of the share buyback being initiated; or regarding potential future
sales or earnings of the Novartis Group or any of its divisions; or by
discussions of strategy, plans, expectations or intentions. You should not place
undue reliance on these statements. Such forward-looking statements reflect the
current views of the Group regarding future events, and involve known and
unknown risks, uncertainties and other factors that may cause actual results to
be materially different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee that any new
products will be approved for sale in any market, or that any new indications
will be approved for any existing products in any market, or that any approvals
which are obtained will be obtained at any particular time, or that any such
products will achieve any particular revenue levels. Nor can there be any
guarantee that the proposed divestiture of the blood transfusion diagnostics
unit will be completed in the expected form or within the expected time frame or
at all. Nor can there be any guarantee that Novartis will be able to realize any
of the potential strategic benefits, synergies or opportunities as a result of
the divestiture. Neither can there be any guarantee that shareholders will
achieve any particular level of shareholder returns or regarding the potential
outcome of the share buyback being initiated. N0r can there be any guarantee
that the Group, or any of its divisions, will achieve any particular financial
results or any particular credit rating. In particular, management's
expectations could be affected by, among other things, unexpected regulatory
actions or delays or government regulation generally, including an unexpected
failure to obtain necessary government approvals for the transaction, or
unexpected delays in obtaining such approvals; the potential that the potential
strategic benefits, synergies or opportunities expected from the transaction may
not be realized or may take longer to realize than expected; the inherent
uncertainties involved in predicting shareholder returns or credit ratings;
unexpected clinical trial results, including additional analyses of existing
clinical data or unexpected new clinical data; the Group's ability to obtain or
maintain patent or other proprietary intellectual property protection, including
the ultimate extent of the impact on the Group of the loss of patent protection
and exclusivity on key products which commenced last year and will continue this
year; unexpected product manufacturing and quality issues, including the
resolution of the Warning Letter issued to us with respect to three Sandoz
manufacturing facilities, and the completion of efforts to restart production of
certain products formerly produced at the Consumer Health manufacturing facility
at Lincoln, Nebraska, and the restructuring efforts at that site; government,
industry, and general public pricing pressures; uncertainties regarding actual
or potential legal proceedings, including, among others, actual or potential
product liability litigation, litigation and investigations regarding sales and
marketing practices, shareholder litigation, government investigations and
intellectual property disputes; competition in general; uncertainties regarding
the effects of the ongoing global financial and economic crisis, including the
financial troubles in certain Eurozone countries; uncertainties regarding future
global exchange rates; uncertainties regarding future demand for our products;
uncertainties involved in the development of new healthcare products; the impact
that the foregoing factors could have on the values attributed to the Group's
assets and liabilities as recorded in the Group's consolidated balance sheet;
and other risks and factors referred to in Novartis AG's current Form 20-F on
file with the US Securities and Exchange Commission. Should one or more of these
risks or uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those described herein as
anticipated, believed, estimated or expected. Novartis is providing the
information in this press release as of this date and does not undertake any
obligation to update any forward-looking statements as a result of new
information, future events or otherwise.
About Novartis
Novartis provides innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
eye care, cost-saving generic pharmaceuticals, preventive vaccines and
diagnostic tools, over-the-counter and animal health products. Novartis is the
only global company with leading positions in these areas. In 2012, the Group
achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted
to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 133,000
full-time equivalent associates and operate in more than 140 countries around
the world. For more information, please visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis.
# # #
Novartis Media Relations
Central media line : +41 61 324 2200
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Novartis Global Media Relations Novartis Global Media Relations
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Donofrio
e-mail: investor.relations(at)novartis.com e-mail:
investor.relations(at)novartis.com
[*] This will be done on the basis of a decision made by the Annual General
Meeting 2008 for a share buyback program of up to CHF 10 billion, of which CHF
7.6 billion is still available.
Media release (PDF):
http://hugin.info/134323/R/1745088/587308.pdf
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Source: Novartis International AG via Thomson Reuters ONE
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Datum: 22.11.2013 - 07:00 Uhr
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