Novartis delivers strong underlying financial performance in 2011, expects 2012 sales to be in line with 2011
• Fourth quarter sales rose 5% while core[1] operating
income grew 17% in constant currencies (cc); full year sales up 12%
cc and core operating income up 16% cc
o Net sales increased 4% (+5% cc) to USD 14.8 billion; full year up
16% (+12% cc) to USD 58.6 billion
o Core operating income grew 12% (+17% cc) to USD 3.6 billion in
the fourth quarter; full year up 14% (+16% cc) to USD 15.9 billion;
core margin of 24.0% up 2.7 percentage points in cc; full year core
margin of 27.2% up 1.1 percentage points in cc
o Core EPS advanced 8% to USD 1.23 (+13% cc) from USD 1.14 in the
previous-year quarter; full year core EPS up by 8% (+11% cc) to USD
5.57
o Operating income declined 47% (-38% cc) in the quarter and 5%
(+1% cc) for the full year, driven by fourth quarter net
exceptional charges totaling USD 1.5 billion; EPS declined 48%
(-40% cc) in the quarter and 11% (-5% cc) for the full year
o Free cash flow of USD 3.9 billion; full year free cash flow of
USD 12.5 billion
o Dividend of CHF 2.25 per share proposed for 2011; 15th
consecutive increase
• Diversified healthcare portfolio and industry-leading
pipeline expected to enhance our ability to sustain growth through
patent expirations
o Alcon, world leader in eye care, fully integrated as second
largest division in Novartis Group portfolio
o Portfolio rejuvenation continues to gain momentum with Group
recently launched products growing 38% and contributing 25% (USD
14.4 billion) of 2011 net sales
o Strong Pharmaceuticals pipeline results with 15 approvals in the
US, EU and Japan in 2011; worldwide filings underway for Afinitor
in breast cancer
• Outlook 2012: Novartis expects sales to be in line with 2011
despite Diovan patent expiry and Tekturna/Rasilez decline; core
operating income margin (cc) expected to be slightly below
2011
Key figures
Q4 2011 Q4 2010 % change FY 2011 FY 2010 % change
USD m USD m USD cc USD m USD m USD cc
Net sales 14 781 14 199 4 5 58 566 50 624 16 12
Operating income 1 317 2 467 -47 -38 10 998 11 526 -5 1
Net income 1 210 2 265 -47 -37 9 245 9 969 -7 -2
EPS (USD) 0.49 0.95 -48 -40 3.83 4.28 -11 -5
Free cash flow 3 909 4 180 -6 12 503 12 346 1
Core[1]
Operating income 3 550 3 166 12 17 15 909 14 006 14 16
Net income 3 011 2 803 7 12 13 490 12 029 12 15
EPS (USD) 1.23 1.14 8 13 5.57 5.15 8 11
[1] See page 52 for further information and definition of core
results
Basel, January 25, 2012 - Commenting on the results, Joseph
Jimenez, CEO of Novartis, said:
"Novartis achieved solid sales growth and strong operating leverage
in the fourth quarter and for the year as a whole. We maintained
our innovation momentum this year, achieving 15 key approvals and
expanding our already robust pipeline. We also improved core
margins through targeted productivity initiatives. However, we
experienced some disappointments in the fourth quarter, with
Tekturna/Rasilez and with the need to improve our quality standards
at some manufacturing sites. We are committed to ensuring one
single high quality standard across Novartis and will invest the
necessary resources to achieve this goal in all divisions. Novartis
is well positioned as we face the expected patent expirations and
will continue discovering new treatments to improve the health of
patients across the globe."
GROUP REVIEW
Fourth quarter
Strong net sales growth driven by recently launched products
Net sales rose 4% (+5% cc) to USD 14.8 billion in the fourth
quarter. The strengthening of the US dollar against most major
currencies negatively impacted sales by 1 percentage point.
Our portfolio rejuvenation continued to drive overall growth for
the Group, as recently launched products sales grew 30% (USD) over
the previous-year quarter to USD 3.7 billion. These products
contributed 25% (USD) of Group net sales, up from 20% in the
year-ago period.
Pharmaceuticals net sales grew 4% (+5% cc) to USD 8.3 billion,
driven by 10 percentage points of volume growth, partly offset by
generic entries and product divestments, which had a negative
impact of 5 percentage points. Alcon net sales of USD 2.4 billion
rose 6% (+7% cc) on a pro forma basis, while Sandoz net sales
declined 5% (-4% cc) to USD 2.3 billion due to additional
competition to enoxaparin. Vaccines and Diagnostics net sales
expanded 86% (+86% cc) to USD 671 million. Consumer Health - which
comprises OTC and Animal Health - was down 7% (-6% cc) at USD 1.1
billion due to OTC product return provisions, following the
temporary suspension of production at one of the US Consumer Health
sites.
Operating income was down 47% (-38% cc) to USD 1.3 billion.
Exceptional income and expense in the fourth quarter amounted to a
net USD 1.5 billion expense compared to USD 397 million expense in
the prior year. The strengthening of the US dollar, combined with
the already strong Swiss franc, resulted in a negative currency
impact of 9 percentage points.
The net exceptional charge of USD 1.5 billion (2010 USD 397
million) comprised charges of USD 1.7 billion (2010 USD 789
million) offset by exceptional income of USD 186 million (2010 USD
392 million mainly related to the Enablex® divestment).
Exceptional charges included: USD 903 million for Tekturna/Rasilez,
USD 163 million related to the discontinuation of the PRT128
(elinogrel) and SMC021 (oral calcitonin) development programs, a
charge of USD 115 million related to the temporary suspension of
production at one of our US Consumer Health sites, Alcon
integration charges of USD 61 million, and restructuring costs of
USD 288 million. Exceptional income includes a USD 106 million
reduction of a contingent consideration obligation in Sandoz.
Amortization of intangible assets amounted to USD 742 million
compared to USD 302 million in 2010 mainly as a result of the Alcon
acquisition.
Core operating income grew strongly ahead of sales
Core operating income, which excludes the exceptional items
identified above together with amortization of intangible assets,
increased by 12% (+17% cc) to USD 3.6 billion. Core operating
income margin in constant currencies increased by 2.7 percentage
points. However, this improvement was offset by a negative currency
impact of 1.0 percentage point, resulting in a net increase in core
operating income margin of 1.7 percentage points to 24.0% of net
sales.
Net income decreased 47% (-37% cc), in line with the decline in
operating income. EPS declined 48% (-40% cc) at a slightly higher
rate than net income as a result of the increase in issued shares
following the Alcon merger, partially offset by a lower impact from
non-controlling interests.
Core net income grew 7% (+12% cc) below the rate of growth of core
operating income as a result of a higher core tax charge (15%
compared to 10% in the prior year). Core EPS was up by 8% (+13%
cc).
Free cash flow of USD 3.9 billion was 6% lower than in the
previous-year quarter mainly as a result of the Enablex®
divestment proceeds of USD 392 million in the fourth quarter of
2010.
Full year
Double-digit net sales growth
Net sales rose 16% (+12% cc) to USD 58.6 billion, with a positive
currency impact of 4% arising from the weakness of the US dollar
against most major currencies during much of 2011.
Recently launched products sales grew 38% over 2010 (in USD,
excluding the A(H1N1) pandemic flu vaccine and including Alcon on a
pro forma basis for 2010) to USD 14.4 billion. These products
contributed 25% of Group net sales, up from 19% in 2010.
Pharmaceuticals net sales grew 7% (+4% cc) to USD 32.5 billion, and
Alcon net sales of USD 10.0 billion rose 10% (+7% cc) on a pro
forma basis. Sandoz net sales also grew 10% (+7% cc) to USD 9.5
billion. Vaccines and Diagnostics net sales were down 32% (-34% cc)
to USD 2.0 billion, mainly due to USD 1.3 billion of A(H1N1)
pandemic flu vaccine sales in 2010. Net sales of the two Consumer
Health businesses together grew 6% (+3% cc) to USD 4.6
billion.
Operating income was down 5% (+1% cc) to USD 11.0 billion.
Exceptional income and expense in 2011 amounted to a net USD 1.9
billion expense compared to USD 1.3 billion expense in the prior
year. The weakness of the US dollar, combined with the strong Swiss
franc, resulted in a negative currency impact of 6 percentage
points.
The net exceptional charge of USD 1.9 billion (2010 USD 1.3
billion) comprised charges of USD 2.9 billion (2010 USD 2.1
billion) offset by exceptional income of USD 1.0 billion (2010 USD
732 million). Exceptional charges included: charges for
Tekturna/Rasilez (USD 903 million), USD 348 million related to the
discontinuation of the PRT128 (elinogrel), SMC021 (oral
calcitonin), AGO178 (agomelatine), and PTK796 development programs,
a charge of USD 115 million related to the temporary suspension of
production at one of our US Consumer Health sites, other intangible
asset impairment charges of USD 71 million principally relating to
development projects, financial asset impairment charges of USD 192
million, integration charges of USD 250 million (mainly for Alcon),
and restructuring and related costs of USD 492 million. Exceptional
income includes divestment proceeds (USD 480 million) and a USD 106
million reduction of a contingent consideration obligation in
Sandoz. For the full year, amortization of intangible assets
amounted to USD 3.0 billion compared to USD 1.1 billion in 2010 as
a result of a full year of incorporating Alcon.
Constant currency core margin up 1.1 percentage points
As a result, core operating income, which excludes the exceptional
items identified above together with amortization of intangible
assets, increased 14% (+16% cc) to USD 15.9 billion. Core operating
income margin in constant currencies increased by 1.1 percentage
points. However, this improvement was offset by a negative currency
impact of 1.6 percentage points, resulting in a net decrease in
core operating income margin of 0.5 percentage points to 27.2% of
net sales.
Net income decreased 7% (-2% cc) to USD 9.2 billion, more than the
decline in operating income as a result of lower associated company
income, higher financing costs following the Alcon acquisition,
partly offset by a lower tax rate (14.2% compared to 14.8%). EPS
declined 11% (-5% cc), more than the decline in net income, mainly
as a result of the increase in issued shares following the Alcon
merger, partially offset by a lower impact from non-controlling
interests.
Core net income grew 12% (+15% cc) to USD 13.5 billion broadly in
line with core operating income. Core EPS was up by 8% (+11% cc): a
lower rate than net income as a result of a higher number of
outstanding shares in 2011.
Free cash flow reached USD 12.5 billion (2010 USD 12.3 billion), an
increase of 1% over the previous year. Free cash flow in 2010
included substantial cash flows from sales of A(H1N1) amounting to
USD 1.8 billion.
Delivering against strategic priorities of innovation, growth and
productivity
The Novartis strategy for sustained, long-term growth is based on
advancing science to meet global patient needs across the
healthcare spectrum and is underpinned by a consistent focus on
three key priorities: innovation, growth and productivity. On all
of these fronts, Novartis made significant progress in 2011, and
the key developments in the fourth quarter are listed below.
Innovation: Bringing new innovative medicines to patients
Scientific innovation is at the heart of the Novartis strategy. We
plan to maintain our industry-leading commitment to R&D, which
we expect will allow us to discover and develop new targeted
therapies for patients worldwide. Our track record of innovation
excellence, which has produced one of the most productive pipelines
in the global pharmaceutical industry, is expected to help us
maintain growth momentum despite the anticipated loss of revenues
from patent expirations.
Regulatory filings underway for Afinitor in breast cancer
In the fourth quarter, we filed applications worldwide for approval
of Afinitor (everolimus) in advanced ER+/HER2- breast cancer,
potentially representing the first major breakthrough in the
treatment of this disease in 15 years. The filing was based on
updated data from a Phase III trial (BOLERO-2) of everolimus in
combination with exemestane for postmenopausal women with advanced
breast cancer that recurred or progressed despite treatment with
hormonal therapies. If approved, this indication for everolimus -
which is already approved for the treatment of advanced kidney
cancer, advanced pancreatic neuroendocrine tumors and subependymal
giant cell astrocytomas associated with tuberous sclerosis complex,
as well as other non-oncology indications - would further validate
the Novartis research strategy, which is based on understanding the
molecular pathways of diseases.
A separate Phase III study (GRANITE-1) of everolimus in patients
with advanced gastric cancer did not meet its primary endpoint,
with everolimus plus best supportive care (BSC) failing to show a
statistically significant difference over placebo plus BSC in
overall survival.
ACZ885 Phase III study showed promise for treatment of childhood
arthritis
A study of ACZ885 showed that 45% of children with active systemic
juvenile idiopathic arthritis (SJIA) were able to substantially
reduce their use of steroids within 28 weeks of commencing
treatment with ACZ885. The study also showed SJIA patients treated
with ACZ885 were nearly three times less likely to suffer a new
flare versus placebo. A subtype of the more common juvenile
idiopathic arthritis, SJIA is the most serious form of childhood
arthritis, and the positive results of this study represent another
success in the Novartis commitment to finding new treatments
wherever there is patient need.
Two Phase III studies continued to show superiority of Tasigna over
Glivec
Data from two studies (ENESTcmr and ENESTnd) contributed to the
growing body of evidence indicating that adult patients with
Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML)
who are treated with Tasigna have a better response at the
molecular level than those treated with Glivec, the long-time
standard of care.
Updated positive Phase III results of INC424 in myelofibrosis
Two pivotal Phase III trials (COMFORT-I and -II) demonstrated the
significant potential of Janus kinase inhibitor INC424 in treating
patients with myelofibrosis, a life-threatening blood cancer.
COMFORT-II data showed that INC424 provided improvements in
symptoms at each evaluation versus the best available therapy,
underlining the dramatic benefits that INC424 can have on quality
of life for patients suffering from this debilitating disease. In
addition, in the COMFORT-I survival analysis, INC424 demonstrated
an early overall survival advantage over placebo.
Gilenya continued to demonstrate efficacy in large-scale clinical
trials; FDA and EMA review of benefits and risks
Now supported by more than 25,000 patients on drug, Gilenya, our
breakthrough oral multiple sclerosis (MS) treatment, continues to
demonstrate efficacy in Phase III studies. In the fourth quarter,
new data from the FREEDOMS II trial showed patients with
relapsing-remitting multiple sclerosis treated with Gilenya
experienced a 48% reduction in relapse rates compared to placebo.
These results, which are consistent with two previous studies,
underscore the potential that Gilenya holds for patients and the MS
community.
Novartis is working with the European Medicine's Agency (EMA) and
the US Food and Drug Administration (FDA) on their reviews of the
benefits and risks of Gilenya that were initiated following the
report of a patient death that occurred within 24 hours after
receiving the first dose of Gilenya in November 2011. The FDA has
stated that, at this time, it cannot conclude whether the drug
resulted in the November 2011 patient death. According to the EMA,
the cause of that patient death is still unexplained. In addition,
the EMA described 10 other deaths as being of potential interest
but noted that the role of Gilenya in these deaths has not been
established. These other events preceded the November 2011 death,
and were reported to the health authorities per regulations.
During the EMA review process and following the recent consultation
with the Committee for Medicinal Products for Human Use (CHMP),
Novartis is in the process of notifying physicians of new interim
recommendations regarding the initiation of treatment with Gilenya
in the European Union to be effective immediately. This includes
the addition of continuous electrocardiogram (ECG) monitoring
during the six-hour observation period following the first dose.
First dose monitoring is already recommended in the Gilenya label.
In patients who meet certain specified criteria, monitoring should
be extended.
Positive Phase II results for DEB025 in hepatitis C
A study of first-in-class DEB025 showed that it may produce early
viral clearance in previously untreated patients infected with the
hepatitis C virus (HCV) genotypes 2 and 3. Instead of targeting the
virus directly, DEB025 targets host proteins essential for the
replication of all types of HCV. DEB025 has the potential to be an
effective treatment option across HCV genotypes with favorable
tolerability and a high barrier to resistance, a promising
development for the more than 170 million people worldwide who are
infected with HCV.
ALTITUDE trial with Tekturna/Rasilez stopped
In late December, following the seventh interim review of data from
the ALTITUDE study with Tekturna/Rasilez, Novartis announced that
the trial was halted on the recommendation of the independent Data
Monitoring Committee (DMC) overseeing the study. The DMC concluded
that patients were unlikely to benefit from treatment on top of
standard anti-hypertensive medicines, and identified higher adverse
events in patients receiving Tekturna/Rasilez in addition to
standard of care as part of the trial. Following discussions with
health authorities, Novartis has written to healthcare
professionals worldwide recommending that hypertensive patients
with diabetes should not be treated with Tekturna/Rasilez, or
combination products containing aliskiren, if they are also
receiving an angiotensin-converting enzyme (ACE) inhibitor or
angiotensin receptor blocker (ARB). As an additional precautionary
measure, Novartis has ceased promotion of Tekturna/Rasilez-based
products for use in combination with an ACE inhibitor or ARB.
Alcon devices approved in Japan
The EX-PRESS Glaucoma Filtration Device (P50PL and P200PL) and the
WaveLight Allegretto Wave Eye-Q Refractive Laser gained approval in
Japan in the fourth quarter. The EX-PRESS Glaucoma Filtration
Device is the first glaucoma filtration device in Japan and
complements Alcon's pharmaceutical eye drops, such as Travatan Z
and DuoTrav, in physicians' treatment of glaucoma patients. The
filtration device provides an easier path for the physician to
drain aqueous fluid from the anterior chamber of the eye, compared
to the current trabeculectomy procedure, providing a more
consistent surgical procedure and more predictable patient
outcomes. The Eye-Q excimer laser has enhanced pulse frequency of
400 Hz while providing innovative and reliable eye tracking and
improved ergonomics for the physician and patient.
Positive CHMP opinion for Nepafenac
The EMA's Committee for Medicinal Products for Human Use adopted a
positive opinion in the fourth quarter for expanding the label
claim for Nepafenac, an ophthalmic suspension that treats eye pain
and inflammation resulting from cataract surgery, adding an
indication for the reduction in the risk of postoperative macular
edema associated with cataract surgery in diabetic patients.
Macular edema is an important complication that can lead to
permanent loss of vision in patients with diabetes who undergo
cataract surgery.
Alcon's refractive offering expanded through US approval
The WaveLight EX500 Excimer Laser gained approval in the US in the
fourth quarter. The WaveLight EX500 system improves refractive
outcomes while offering additional precision and safety in laser
eye surgery procedures. This approval follows the earlier
certification of the WaveLight FS200 Femtosecond Laser in 2010,
which allows Alcon to offer physicians an integrated Refractive
Suite where the two lasers communicate - saving time and improving
refractive outcomes.
Two additional Phase III studies underline Sandoz leadership in
biosimilars
In January, Sandoz announced two Phase III clinical trials for
daily filgrastim (generic Neupogen®) and once-per-cycle
pegfilgrastim (generic Neulasta®) in breast cancer patients
eligible for myelosuppressive chemotherapy treatment. Filgrastim, a
granulocyte-colony stimulating factor (G-CSF) analog, is used to
prevent or treat neutropenia, a common side effect of chemotherapy
characterized by low white blood cell count. Sandoz's filgrastim
biosimilar is already marketed under the brand name Zarzio in more
than 30 countries outside the US, and this study is expected to
support extension of commercialization to the US. The pegfilgrastim
study represents the next major step in the Sandoz global
biosimilar development program, which aims to create the number one
overall G-CSF franchise worldwide.
Growth: Meeting healthcare needs worldwide
Recently launched products fueled growth
Benefitting from our investment in innovation, Novartis has a
strong platform for growth, with several potential blockbuster
products in our Pharmaceuticals portfolio, including Gilenya,
Tasigna, Lucentis, Galvus, Afinitor, Xolair and Onbrez Breezhaler.
Products launched since 2007 continued to fuel growth, contributing
USD 3.7 billion or 25% of net sales in the fourth quarter and USD
14.4 billion (25% of net sales) for the full year.
Following its launch in the US in October 2010 and in parts of the
EU in March 2011, Gilenya, the first oral treatment for multiple
sclerosis, continued its strong growth trajectory with sales of USD
203 million in the fourth quarter (USD 494 million for the full
year). This once daily treatment represents a major advance in the
treatment of MS, a chronic and debilitating disease, as evidenced
by the more than 25,000 patients currently being treated with
Gilenya globally.
Tasigna (USD 207 million, +65% cc), a next-generation therapy for
chronic myeloid leukemia (CML), also achieved strong growth, as
studies continue to show its superiority even to Glivec in treating
patients with this life-threatening blood cancer. Tasigna now
represents more than 19% of our total CML franchise and achieved
sales of USD 716 million for the full year (+74% cc).
Additionally, Lucentis (USD 550 million, +39% cc), a medicine that
significantly improves vision in patients with wet age-related
macular degeneration, made a very important contribution to
Pharmaceuticals growth. In the first half of 2011, Lucentis was
also approved in the EU and Switzerland for the treatment of visual
impairment due to diabetic macular edema and macular edema
secondary to retinal vein occlusion, which further contributed to
growth. Sales for the full year totaled USD 2.0 billion (+26%
cc).
Accelerated growth in emerging markets
Our long-term growth is supported by our established presence in
emerging markets. Sales in our top six emerging markets - Brazil,
China, India, Russia, South Korea and Turkey - grew 15% in cc in
the fourth quarter resulting in USD 1.5 billion or 10% of Group net
sales. The strong performance was particularly driven by Russia and
China. For the full year, sales from the top six emerging markets
aggregated USD 5.8 billion (10% of Group sales).
Solid performance across divisions
Strong underlying growth in the fourth quarter was driven by
Pharmaceuticals, Alcon and Vaccines and Diagnostics. Despite
headwinds from loss of exclusivity and pricing pressures,
Pharmaceuticals continued to perform strongly, with net sales of
USD 8.3 billion expanding 4% (+5% cc) over the same period last
year, underpinned by 38% (in cc) growth in recently launched
products.
Alcon, which represents a new growth platform for Novartis,
contributed USD 2.4 billion in net sales for the quarter, growing
6% (+7% cc) over the same period last year on a pro forma basis
with particularly strong performances by the Surgical and
Ophthalmic Pharmaceuticals franchises.
Sandoz net sales of USD 2.3 billion were down 5% (-4% cc) in the
fourth quarter, impacted by additional competition to enoxaparin.
Enoxaparin, our first generic blockbuster, achieved sales of USD
1.0 billion in 2011 (USD 225 million in the fourth quarter).
Vaccines and Diagnostics grew 86% (+86% cc) with net sales of USD
671 million for the fourth quarter, underpinned by advances in the
meningococcal disease franchise, particularly Menveo, which
achieved full year net sales of USD 142 million, and the resolution
of shipment delays experienced in prior quarters.
The two Consumer Health businesses, OTC and Animal Health, declined
7% (-6% cc) in the fourth quarter, with net sales of USD 1.1
billion, impacted by a temporary suspension of production at one of
our US Consumer Health sites in December.
Productivity: Improving efficiency and optimizing performance
To free up resources for reinvestment in growth and greater
shareholder returns, Novartis is focused on improving efficiency
and reducing costs across all of our operations. For the full year,
net sales grew 12% (cc) while core operating income increased by
16% (cc). This performance resulted in an improvement in core
operating income margin in constant currencies of 1.1 percentage
points, however currency had a negative impact of 1.6 percentage
points, leading to a net decline in core operating income margin of
0.5 percentage points to 27.2% of net sales. This achievement was
significantly ahead of the expectations we set at the beginning of
the year to "aim to improve core operating income margin in
constant currencies." The improved performance was generated from
both a stronger operating performance as well as a higher delivery
of productivity benefits, which created resources equivalent to
over 4 percentage points of sales.
For the quarter, net sales grew 5% (cc) while core operating income
increased by 17% (cc). This performance resulted in an improvement
in core operating income margin in constant currencies of 2.7
percentage points, however currency had a negative impact of 1.0
percentage points, leading to a net increase in core operating
income margin of 1.7 percentage points to 24.0% of net sales.
Within manufacturing, we have two core aims: to create
Manufacturing Centers of Excellence that can support the global
operations of all six Novartis businesses; and to optimize the cost
structure across divisions and enhance utilization rates at
strategic sites to an industry-leading 80% of capacity. We
announced the exit or partial exit from ten sites in 2011, totaling
fourteen site exits since the program began. This enabled us to
reduce excess capacity and shift strategic production to technology
competence centers.
We recorded charges related to exits, impairment charges and
inventory write-offs of USD 92 million in
the fourth quarter, USD 269 million in full year 2011, and USD 332
million cumulatively since the program began in the fourth quarter
of 2010.
Additional efficiency gains are expected by further optimizing our
Marketing & Sales spend. This is part of a broader effort
within Novartis to continue to reallocate resources geographically
while simplifying processes across the organization. Marketing
& Sales spend decreased as a percentage of net sales from 26.3%
in 2010 to 25.7% in 2011.
Procurement is a major source of savings. By leveraging our scale,
implementing global category management and creating country
Centers of Excellence in key markets, we generated annual savings
of USD 1.3 billion.
With regard to General & Administration expenses, the
streamlining of core processes across Novartis and the
implementation of core service centers for functions such as Human
Resources and Finance is expected to further provide operating
leverage.
Alcon, now fully integrated as the second largest division in the
Novartis Group portfolio, has realized merger-related cost
synergies in line with expectations. In the quarter, Alcon
delivered USD 41 million of post-integration synergies, and in the
full year, realized synergies amounting to USD 75 million.
Free cash flow
The sustainability of our strategy lies with the generation of cash
flow that provides the resources for reinvestment and returns to
shareholders. Cash flow is driven by a continued focus on the cash
conversion cycle and operational cash flow improvements. Free cash
flow was USD 3.9 billion for the fourth quarter, declining 6% from
the previous year mainly as a result of the divestment of
Enablex® in the fourth quarter of 2010 (USD 392 million). For
full year 2011, free cash flow was USD 12.5 billion, an increase of
1% over the previous year. Free cash flow in 2010 included
substantial cash flows from sales of A(H1N1) amounting to USD 1.8
billion.
Capital structure and net debt
Strong cash flows and a sound capital structure have allowed
Novartis to invest in the future of its business through R&D
and acquisitions even in turbulent times while keeping its double-A
rating as a reflection of financial strength. Retaining a good
balance between attractive shareholder returns, investment in the
business and a sound capital structure will remain a priority in
the future.
Free cash flow of USD 12.5 billion was deployed for dividend
payments of USD 5.4 billion and share repurchases of USD 5.9
billion (including USD 2.4 billion repurchased indirectly via
Alcon, Inc. to reduce the dilutive impact of the subsequent merger
of Alcon, Inc. into Novartis AG). In total, dividends and share
repurchases utilized 90% of the Group's 2011 free cash flow.
In the fourth quarter, Novartis purchased 12.2 million of own
shares totaling USD 0.6 billion on the first trading line. These
shares will be kept as treasury shares, mostly to cover future
employee participation programs. For the full year 2011, Novartis
repurchased 59.8 million shares totaling USD 3.5 billion. Of this,
USD 2.4 billion was used to repurchase 39.4 million shares on the
second line to reduce the dilutive impact of the share issue
related to the Alcon merger, and USD 1.1 billion was used to buy
20.4 million shares on the first line to mostly cover future
employee participation programs. The company will continue to
acquire shares opportunistically for this purpose, such that
together with the dividend a majority of free cash flow is expected
to be returned to shareholders.
As of December 31, 2011, net debt stood at USD 15.2 billion. This
represents a net increase of USD 0.3 billion since December 31,
2010. The peak Novartis net debt amount of USD 22.7 billion was
reached at the beginning of the second quarter of 2011. This has
been repaid to the extent of USD 7.5 billion by the year end. The
long-term credit rating for the company continues to be double-A
(Moody's Aa2; Standard & Poor's AA-; Fitch AA).
2012 Group outlook
(Barring unforeseen events)
Group constant currency net sales are expected to be in line with
2011.
Products launched since 2007 are expected to continue to grow
strongly and compensate for the negative impacts of generic
competition, lower Tekturna/Rasilez sales (expected to be less than
half of 2011 sales), anticipated price reductions and the expected
reduction of enoxaparin sales. This expectation assumes a mid-year
start of shipments out of the Lincoln plant.
Group core operating income margin in constant currencies is
expected to be slightly below 2011 core operating income
margin.
While productivity measures and margin improvements on products
launched since 2007 are important contributions to improving
profitability, they are not expected to fully offset the loss of
margin from generic competition, price erosion, new investments
necessary to sustain growth in new products and the impact of a
delayed start-up of Lincoln, should it occur.
Annual General Meeting
Dividend proposal
The Board proposes a dividend payment of CHF 2.25 per share for
2011, up 2% from CHF 2.20 per share in 2010, representing the 15th
consecutive dividend increase since the creation of Novartis in
December 1996. Shareholders will vote on this at the 2011 Annual
General Meeting scheduled for February 23, 2012. The payout ratio
as a percentage of net income increased from 54.8% to 63.2%.
Election of Members to the Novartis Board of Directors
At the Annual General Meeting scheduled for February 23, 2012, the
Novartis Board of Directors also proposes the re-election of
Srikant Datar Ph.D., Andreas von Planta Ph.D. and Dr. Ing. Wendelin
Wiedeking for a three-year term each, and William Brody M.D. Ph.D.
and Rolf M. Zinkernagel M.D. for a two-year term each (due to their
reaching the age limit).
The Board further recommends the election of Dimitri Azar M.D. to
the Novartis Board of Directors for a three-year term. Dr. Azar, a
US citizen, is Dean of the College of Medicine and Professor of
Ophthalmology, Bioengineering, and Pharmacology of the University
of Illinois at Chicago, USA. He holds a medical degree from the
American University of Beirut, Lebanon, an Honorary MA from Harvard
University and an Executive MBA from the University of Chicago,
Booth School of Business. Dr. Azar is an internationally recognized
ophthalmic surgeon and prolific researcher. He has been named one
of The Best Doctors in America and one of the Castle Connolly Top
Doctors in America annually since 1994. He holds multiple committee
positions with the American Academy of Ophthalmology, is a member
of the American Ophthalmological Association, and sits on the Board
of Trustees of the Chicago Ophthalmological Society and the
Association of Research in Vision and Ophthalmology. He has
received multiple leadership awards, including the 2009 Lans
Distinguished Award from the International Society of Refractive
Surgery.
GROUP AND DIVISIONAL OPERATING PERFORMANCE
Group
Q4 2011 Q4 2010 % change FY 2011 FY 2010 % change
USD m USD m USD cc USD m USD m USD cc
Net sales 14 781 14 199 4 5 58 566 50 624 16 12
Operating income 1 317 2 467 -47 -38 10 998 11 526 -5 1
As % of net sales 8.9 17.4 18.8 22.8
Net income 1 210 2 265 -47 -37 9 245 9 969 -7 -2
EPS (USD) 0.49 0.95 -48 -40 3.83 4.28 -11 -5
Free cash flow 3 909 4 180 -6 12 503 12 346 1
Core
Operating income 3 550 3 166 12 17 15 909 14 006 14 16
As % of net sales 24.0 22.3 27.2 27.7
Net income 3 011 2 803 7 12 13 490 12 029 12 15
EPS (USD) 1.23 1.14 8 13 5.57 5.15 8 11
Fourth quarter
Net sales
Net sales rose 4% (+5% cc) to USD 14.8 billion in the fourth
quarter. The strengthening of the US dollar against most major
currencies negatively impacts sales by 1%. Sales were up mainly due
to a strong performance from recently launched products, which
contributed USD 3.7 billion or 25% to total net sales for the Group
and grew 30% (in USD, excluding the impact of A(H1N1) pandemic flu
vaccine) over the previous-year quarter.
Group operating income
Operating income was down 47% (-38% cc) to USD 1.3 billion.
Exceptional income and expense in the fourth quarter amounted to a
net USD 1.5 billion expense compared to USD 397 million expense in
the prior year. The strengthening of the US dollar, combined with
the already strong Swiss franc, resulted in a negative currency
impact of 9 percentage points.
The net exceptional charge of USD 1.5 billion (2010 USD 397
million) comprised charges of USD 1.7 billion (2010 USD 789
million) offset by exceptional income of USD 186 million (2010 USD
392 million mainly related to the Enablex® divestment).
Exceptional charges included: USD 903 million for Tekturna/Rasilez
(comprising USD 250 million intangible asset impairment, USD 314
million property, plant and equipment impairment, and USD 339
million other exceptional charges), USD 163 million related to the
discontinuation of the PRT128 (elinogrel) and SMC021 (oral
calcitonin) development programs (comprising USD 103 million
intangible asset impairment, USD 47 million property, plant and
equipment impairment, and USD 13 million other exceptional
charges), a charge of USD 115 million (USD 10 million of intangible
asset impairment charge and USD 105 million of other exceptional
charges) related to the temporary suspension of production at one
of our US Consumer Health sites, Alcon integration charges of USD
61 million, and restructuring costs of USD 288 million (including
USD 92 million relating to the streamlining of our manufacturing
network, of which USD 53 million in Switzerland, and other
restructuring charges of USD 196 million, of which USD 154 million
in Switzerland). Exceptional income includes a USD 106 million
reduction of a contingent consideration obligation in Sandoz. In
the prior year, there was an exceptional income of USD 392 million.
For the fourth quarter, acquisition-related items amounted to USD
61 million compared to USD 386 million in 2010, mainly related to
Alcon. Amortization of intangible assets amounted to USD 742
million compared to USD 302 million in 2010 mainly as a result of
the Alcon acquisition.
Core operating income, which excludes the exceptional items
identified above together with amortization of intangible assets,
increased by 12% (+17% cc) to USD 3.6 billion. Core operating
income margin in constant currencies increased by 2.7 percentage
points. However, this improvement was offset by a negative currency
impact of 1.0 percentage points, resulting in a net increase in
core operating income margin of 1.7 percentage points to 24.0% of
net sales.
Income from associated companies
Income from associated companies decreased to USD 130 million from
USD 175 million in the year-ago period. The impact of higher
contributions over the prior-year quarter from Roche of USD 75
million to USD 119 million was more than offset by the prior-year
exceptional additional revaluation gain recorded on the initial 25%
interest in Alcon, Inc. of USD 174 million.
Interest expense and other financial income/expense
For the fourth quarter, interest expense decreased by 11% from USD
196 million to USD 174 million. Other financial income/expense was
a net expense of USD 12 million, down from USD 26 million in the
prior-year period mainly due to a less negative currency result,
which overcompensated lower earnings from investments as a result
of the decreased average liquidity.
Taxes
The tax rate (taxes as percentage of pre-tax income) decreased in
the fourth quarter to 4.0% from 6.4% in the prior-year period,
principally due to the tax benefit on the exceptional charges in
high-tax jurisdictions in 2011.
The core tax rate (taxes as a percentage of core pre-tax income)
increased to 15.3% in 2011 from 9.9% in 2010, mainly due to
favorable phasing of R&D tax credits recorded in the fourth
quarter of 2010.
Net income and EPS
Net income decreased 47% (-37% cc), in line with the decline in
operating income. EPS declined 48% (-40% cc) at a slightly higher
rate than net income as a result of the increase in issued shares
following the Alcon merger, partially offset by a lower impact from
non-controlling interests. The average number of shares outstanding
in the fourth quarter 2011 rose by 5% to 2,413 million from 2,290
million in the year ago period as a result of the shares issued for
the Alcon acquisition. A total of 2,407 million shares were
outstanding at December 31, 2011.
Core net income grew 7% (+12% cc), below the rate of growth of core
operating income as a result of a higher core tax charge. Core EPS
was up by 8% (+13% cc).
Full year
Net sales
Net sales rose 16% (+12% cc) to USD 58.6 billion, with a 4% benefit
arising from the weakness of the US dollar against most major
currencies during much of the year. Recently launched products
(excluding the A(H1N1) pandemic flu vaccine and including Alcon on
a pro forma basis for 2010) grew 38% (USD) over the previous-year
period, contributing USD 14.4 billion or 25% to Group total net
sales.
Group operating income
Operating income was down 5% (+1% cc) to USD 11.0 billion.
Exceptional income and expense in 2011 amounted to a net USD 1.9
billion expense compared to USD 1.3 billion expense in the prior
year. The weakness of the US dollar, combined with the strong Swiss
franc, resulted in a negative currency impact of 6 percentage
points.
The net exceptional charge of USD 1.9 billion (2010 USD 1.3
billion) comprised charges of USD 2.9 billion (2010 USD 2.1
billion) offset by exceptional income of USD 1.0 billion (2010 USD
732 million). Exceptional charges included: Tekturna/Rasilez (USD
903 million, comprising USD 250 million intangible asset
impairment, USD 314 million property, plant and equipment
impairment, and USD 339 million other exceptional charges), USD 348
million related to the discontinuation of the PRT128 (elinogrel),
SMC021 (oral calcitonin), AGO178 (agomelatine), and PTK796
development programs (comprising USD 288 million intangible asset
impairment, USD 47 million property, plant and equipment
impairment, and USD 13 million other exceptional charges), a charge
of USD 115 million related to the temporary suspension of
production at one of our US Consumer Health sites (comprising USD
10 million in intangible asset impairment and USD 105 million other
exceptional charges), other intangible asset impairment charges of
USD 71 million, financial asset impairment charges of USD 192
million, integration charges of USD 250 million (USD 243 million
relating to Alcon), and restructuring costs of USD 492 million
(including USD 269 million relating to the streamlining of our
manufacturing network, of which USD 100 million in Switzerland, and
other restructuring charges of USD 223 million, of which USD 154
million in Switzerland). Exceptional income in 2011 of USD 1.0
billion (2010 USD 732 million) included divestment gains of USD 480
million and a USD 106 million reduction in a contingent
consideration obligation in Sandoz. For the full year,
acquisition-related expenses amounted to USD 250 million compared
to USD 600 million in 2010 mainly related to Alcon. Amortization of
intangible assets amounted to USD 3.0 billion compared to USD 1.1
billion in 2010 mainly as a result of the Alcon acquisition.
As a result, core operating income, which excludes the exceptional
items identified above together with amortization of intangible
assets, increased 14% (+16% cc) to USD 15.9 billion. Core operating
income margin in constant currencies increased by 1.1 percentage
points; however, this improvement was offset by a negative currency
impact of 1.6 percentage points, resulting in a net decrease of 0.5
percentage points to 27.2% of net sales.
Income from associated companies
Income from associated companies in 2011 amounted to USD 528
million compared to USD 804 million in the prior-year period. The
income from Roche was USD 499 million compared to USD 380 million.
The prior year included a contribution from Alcon of USD 433
million, which is no longer included since Alcon, Inc. has been
fully consolidated since August 25, 2010.
Interest expense and other financial income/expense
For the full year 2011, interest expense increased by 9% from USD
692 million to USD 751 million. Other financial income/expense was
a net expense of USD 2 million, down from a net income of USD 64
million in the prior year mainly due to lower earnings from
investments as a result of the decreased average liquidity. The
currency result remained stable.
Taxes
The tax rate (taxes as a percentage of pre-tax income) decreased to
14.2% in 2011 from 14.8% in 2010, mainly due to the favorable
impact of fully consolidating Alcon, Inc. and related tax structure
reorganization.
The core tax rate (taxes as a percentage of core pre-tax income)
decreased to 15.3% in 2011 from 16.6% in 2010, mainly due to the
favorable impact of fully consolidating Alcon, Inc. and related tax
structure reorganization.
Net income and EPS
Net income decreased 7% (-2% cc) to USD 9.2 billion, more than the
decline in operating income as a result of lower associated company
income, higher financing costs following the Alcon acquisition,
partly offset by a lower tax rate (14.2% compared to 14.8%). EPS
declined 11% (-5% cc), more than the decline in net income, mainly
as a result of the increase in issued shares following the Alcon
merger, partially offset by a lower impact from non-controlling
interests. The average number of shares outstanding in 2011 rose 4%
to 2,382 million from 2,286 million in the year ago, while a total
of 2,407 million shares were outstanding at December 31,
2011.
Core net income grew 12% (+15% cc) to USD 13.5 billion broadly in
line with core operating income. Core EPS was up by 8% (+11% cc): a
lower rate than net income as a result of a higher number of
outstanding shares in 2011.
Pharmaceuticals
Q4 2011 Q4 2010 % change FY 2011 FY 2010 % change
USD m USD m USD cc USD m USD m USD cc
Net sales 8 313 7 970 4 5 32 508 30 306 7 4
Operating income 825 2 201 -63 -53 8 296 8 471 -2 4
As % of net sales 9.9 27.6 25.5 28.0
Core operating income 2 289 2 187 5 12 10 040 9 586 5 8
As % of net sales 27.5 27.4 30.9 31.6
Fourth quarter
Net sales
Net sales grew 4% (+5% cc) to USD 8.3 billion, driven by 10
percentage points of volume growth and flat pricing, partly offset
by the combined effect of generic entries and product divestments
of 5 percentage points. Products launched since 2007 generated USD
2.5 billion of net sales, growing 38% in constant currencies over
the same period last year. These recently launched products -
Lucentis, Exforge, Exelon Patch, Exjade, Reclast/Aclasta,
Tekturna/Rasilez, Tasigna, Afinitor, Onbrez Breezhaler, Ilaris,
Fanapt and Gilenya - now comprise 30% of division sales, compared
to 23% in the same period last year.
Europe (USD 2.8 billion, 0% cc) maintained strong volume growth of
13 percentage points, offsetting a negative pricing impact of 7
percentage points and the effect of generic entries of 6 percentage
points. Recently launched products continued to grow strongly in
European countries, contributing 38% of net sales for the region.
US sales (USD 2.6 billion, 2% cc) benefitted from strong growth for
Tasigna and Gilenya, which offset the generic competition for
Femara and high-dose Lotrel. Latin America and Canada (USD 0.8
billion, +12% cc) achieved strong growth rates, and Japan's sales
(USD 1.1 billion, +7% cc) improved versus the same period last year
primarily due to new launches. The top six emerging markets (USD
0.8 billion, +12% cc) were led by particularly strong growth in
China, India and Russia.
Most strategic franchises contributed to business expansion.
Oncology (USD 2.7 billion, +2% cc) delivered strong underlying
growth, suppressed by generic competition for Femara(USD 134
million, -62% cc) in the US and Europe. Growth was driven by the
sustained performance of Gleevec/Glivec and Tasigna (combined sales
of USD 1.4 billion, +14% cc), as well as Sandostatin (USD 374
million, +7% cc) and the recently launched Afinitor, which added
USD 133 million (+66% cc). Cardiovascular and Metabolism franchise
performance (USD 1.9 billion, -7% cc) was underpinned by the
continued strong uptake of Galvus (USD 199 million, +63% cc) and
Exforge (USD 323 million, +30% cc); however, results were impacted
by the sales decline in Diovan (USD 1.3 billion, -17% cc) due to
loss of exclusivity in the EU. The Neuroscience and Ophthalmics
franchise (USD 1.3 billion, +41% cc) saw strong growth from Gilenya
(USD 203 million), following successful launches in both the US and
Europe, and from Lucentis (USD 550 million, +39% cc).
Operating income
Operating income decreased 63% (-53% cc) to USD 0.8 billion.
Exceptional items including amortization amounted to a net USD 1.5
billion expense compared to USD 14 million income in the previous
year. Exceptional items include charges for Tekturna/Rasilez of USD
903 million, restructuring charges of USD 274 million mainly
related to the R&D restructuring announced in the third quarter
earnings release and to the streamlining of our manufacturing
network, impairment and other charges of USD 163 million related to
the discontinuation of the PRT128 (elinogrel) and SMC021
development programs. The prior-year period includes Enablex®
divestment income of USD 392 million.
Core operating income increased 5% (+12% cc) to USD 2.3 billion.
Core operating income margin in constant currencies improved by 1.9
percentage points, but this improvement was mostly offset by a
negative currency impact of 1.8 percentage points, resulting in a
net improvement in core operating income margin of 0.1 percentage
points to 27.5% of net sales. Gross margin declined by 1.5
percentage points, before negative currency effects of 0.6
percentage points, due to increased royalties for Lucentis and
Gilenya and unfavorable product mix. R&D expenses decreased by
1.3 percentage points of net sales in constant currencies.
Marketing & Sales and General & Administration expenses
improved margin by 1.3 percentage points (cc), benefiting from
continuing productivity efforts despite significant investments in
new product launches. Other Income & Expense, net, improved
margin by 0.8 percentage points (cc) mainly due to cost phasing in
the same period last year.
Full year
Net sales
Net sales expanded 7% (+4% cc) to USD 32.5 billion driven by 9
percentage points of volume, partly offset by a negative pricing
impact of 1 percentage point and the combined impact of generic
entries and product divestments of an additional 4 percentage
points. Recently launched products contributed USD 9.2 billion of
net sales, growing 35% in constant currencies over the previous
year. These products now represent 28% of division sales compared
to 22% in 2010.
Europe remained the largest region (USD 11.6 billion, +2% cc) for
Pharmaceuticals, particularly benefiting from recently launched
products, which generated 35% of net sales, more than offsetting
health care cost-containment measures and generic erosion. The US
(USD 10.0 billion, 0% cc) contributed 31% of net sales for the
division. Japan's performance (USD 3.9 billion, +7% cc) improved
versus prior year due to new launches. Latin America and Canada
(USD 3.0 billion, +10% cc) achieved strong growth rates. The top
six emerging markets (USD 3.2 billion, +7% cc) were led by
double-digit growth from China and India.
Operating income
Operating income decreased 2% (+4% cc) to USD 8.3 billion.
Exceptional items including amortization amounted to a net USD 1.7
billion expense compared to USD 1.1 billion expense in 2010.
Exceptional items include Tekturna/Rasilez charges of USD 903
million, restructuring charges of USD 420 million and other
intangible asset impairments of USD 302 million (mainly AGO178,
PTK796, PRT128 and SMC021). These were partly offset by higher
prior-year impairment charges, and divestment income from
Elidel® (USD 324 million) and from ophthalmic pharmaceutical
products related to the Alcon acquisition (USD 81 million).
Core operating income grew 5% (+8% cc) to USD 10.0 billion. In
constant currencies, core operating income margin increased by 1.4
percentage points due to continuing productivity efforts. However,
this improvement was offset by a negative currency impact of 2.1
percentage points, resulting in a net decrease in core operating
income margin of 0.7 percentage points to 30.9% of net sales. The
underlying gross margin decreased by 0.6 percentage points (cc)
mainly driven by increased royalties. Functional costs - which
include General & Administration, Marketing & Sales and
R&D expenses - improved by 2.0 percentage points, driven by
productivity gains in Marketing & Sales and R&D despite
significant investments in new product launches. Other Income &
Expense, net, remained flat in constant currencies.
Alcon
Restated Q4 2011 Q4 2010 FY 2011 FY 2010
USD m USD m USD m USD m
Net sales 2 425 2 285 9 958 4 446
Operating income 236 308 1 472 796
As % of net sales 9.7 13.5 14.8 17.9
Core operating income 796 718 3 492 1 350
As % of net sales 32.8 31.4 35.1 30.4
Pro forma Q4 2011 Q4 2010 % change FY 2011 FY 2010 % change
USD m USD m USD cc USD m USD m USD cc
Net sales 2 425 2 277 6 7 9 949 9 031 10 7
Operating income 236 232 2 -8 1 461 1 181 24 14
As % of net sales 9.7 10.2 14.7 13.1
Core operating income 796 717 11 8 3 490 3 095 13 9
As % of net sales 32.8 31.5 35.1 34.3
As the restated net sales figures prior to August 25, 2010 only
include CIBA Vision and Pharmaceuticals Division Ophthalmics
activities, all of the following comments are based on 2010 pro
forma figures.
Fourth quarter
Net sales
Net sales of USD 2.4 billion rose 6% (+7% cc) on a pro forma basis.
This continued strong performance was led by strong global
Ophthalmic Pharmaceuticals product growth of 8% (+9% cc) and
Surgical products growth of 8% (+9% cc).
US sales rose 8%, led by a strong performance of the Ophthalmic
Pharmaceuticals franchise (mainly infection/inflammation, dry eye,
and otic/nasal products), as well as contact lenses. Sales in
non-US markets increased 5% (+6% cc) to USD 1.5 billion driven by
the Ophthalmic Pharmaceuticals and Surgical product categories.
Sales in the top six emerging markets increased 18% (+23% cc), led
by China, South Korea and India.
Operating income
Operating income of USD 236 million rose 2% (-8% cc) on a pro forma
basis. Fourth quarter operating income includes amortization of
intangible assets (USD 477 million) and integration costs (USD 61
million).
Core operating income of USD 796 million increased by 11% (+8% cc)
on a pro forma basis. Alcon delivered strong operating leverage
through productivity gains and the realization of post-integration
synergies (USD 41 million). Core operating income margin in
constant currencies increased by 0.2 percentage points on a pro
forma basis, with a positive currency impact of 1.1 percentage
points, resulting in a net increase in core operating income margin
of 1.3 percentage points to 32.8% of net sales. Gross margin was
74.1% of net sales and broadly in line with the previous-year
period. R&D expenses represented 9.7% of net sales, also in
line with the 2010 period. Marketing & Sales expenses, which
represented 26.7% of net sales, improved by 1.5 percentage points
despite increased investments in emerging markets. General &
Administration expenses declined from 5.8% to 5.1% of net sales in
the 2011 period, as a result of good cost management and
merger-related cost synergies.
Full year
Net sales
Net sales of USD 10.0 billion rose 10% (+7% cc) on a pro forma
basis, driven by strong global Ophthalmic Pharmaceuticals product
growth of 12% (+10% cc), Surgical products growth of 11% (+8% cc),
and by the top six emerging markets, which grew 26% (+22% cc) over
2010.
Operating income
Operating income of USD 1.5 billion rose 24% (+14% cc) on a pro
forma basis. Full year operating income was impacted by the
inclusion of exceptional income from a litigation settlement (USD
183 million), amortization of intangible assets (USD 1.9 billion),
integration costs (USD 221 million), and the impact of
manufacturing optimization (USD 57 million).
Core operating income of USD 3.5 billion increased by 13% (+9% cc)
on a pro forma basis. Core operating income margin in constant
currencies increased by 0.7 percentage points on a pro forma basis;
in addition, there was a positive currency impact of 0.1 percentage
points, resulting in a net increase in core operating income margin
of 0.8 percentage points to 35.1% of net sales.
Sandoz
Q4 2011 Q4 2010 % change FY 2011 FY 2010 % change
USD m USD m USD cc USD m USD m USD cc
Net sales 2 294 2 420 -5 -4 9 473 8 592 10 7
Operating income 394 292 35 33 1 422 1 321 8 10
As % of net sales 17.2 12.1 15.0 15.4
Core operating income 408 419 -3 -4 1 921 1 742 10 11
As % of net sales 17.8 17.3 20.3 20.3
Fourth quarter
Net sales
Sandoz net sales declined 5% (-4% cc) to USD 2.3 billion, with 5
percentage points of volume expansion more than offset by price
erosion of 9 percentage points. The volume increase was driven by
strong performances in Russia, France, Spain, Japan and Italy, as
well as by biosimilars.
US retail generics and biosimilars (USD 727 million, -4% cc)
declined due to additional competition and associated price decline
for enoxaparin (generic Lovenox®) as well as the significant
180-day launches of both Sandoz's gemcitabine and lansoprazole
authorized generics in the prior-year quarter. German sales of
retail generics and biosimilars (USD 343 million, -4% cc) declined
compared to the prior-year quarter, but improved significantly over
performance in the first nine months of 2011, absorbing the price
impact of statutory health insurance tenders as well as new lower
reference prices. Western Europe retail generics and biosimilars
grew significantly (+9% cc), driven by strong performances in
France, Spain and Italy. Emerging markets growth was led by Latin
America (+14% cc) and Asia (+10% cc).
Sandoz strengthened its number one global position in the
biosimilars segment (USD 77 million, +46%, +48% cc), with strong
momentum across all three of its products - Omnitrope (human growth
hormone), Binocrit (epoetin alfa), and Zarzio (filgrastim) - each
of which is now the leading biosimilar in its respective market
segment.
Operating income
Operating income increased by 33% in constant currencies to USD 394
million. The operating income margin improved by 5.1 percentage
points as compared to the fourth quarter of 2010, reaching 17.2% of
net sales. The operating income margin increased by 4.6 percentage
points more than the core operating income margin, primarily as a
result of a USD 106 million reduction of a contingent consideration
obligation, partly offset by provisions for legal cases in the
US.
Core operating income declined 4% in constant currencies to USD 408
million. Core operating income margin increased by 0.5 percentage
points to 17.8% of net sales. Currency had a positive impact of 0.5
percentage points, resulting in a flat core operating income margin
in constant currencies. Gross margin increased by 2.1 percentage
points (cc), driven by favorable sales mix together with
productivity improvements, partly offset by price erosion and
investments into product quality programs. Marketing & Sales
(-1.1 percentage points in cc) increased due to higher investments
into growing businesses in Western Europe and emerging markets.
R&D expenses (-0.2 percentage points in cc) increased due to
investments in the development of differentiated generics such as
biosimilars and respiratory products, partly offset by productivity
savings. General & Administration expenses (-0.4 percentage
points in cc) increased due to declining sales in the quarter.
Other Income & Expense, net, (-0.4 percentage points in cc)
increased mainly due to higher costs of restructuring in 2011
(below the threshold for exclusion from core).
Full year
Net sales
Sandoz achieved strong sales growth in 2011 (USD 9.5 billion, +10%,
+7% cc) versus prior year driven by significant growth in US retail
generics and biosimilars (+22% cc), with sales of over USD 1
billion for enoxaparin. Strong performances in Canada (+13% cc),
Western Europe (+13% cc), Latin America (+12% cc), Asia (+12% cc)
and Central and Eastern Europe (+6% cc) also contributed to growth
in the full year. Germany retail generics and biosimilars declined
(-13% cc) in a market that is estimated to have contracted 17% in
net terms due to the impact of statutory health insurance tenders
and new lower reference prices. Biosimilars grew 37% in constant
currencies to USD 261 million globally. Sales volume expanded 14
percentage points due to new product launches, and Falcon
(transferred from Alcon) contributed 2 additional percentage points
of growth, more than compensating price erosion of 9 percentage
points.
Operating income
Operating income grew 10% in constant currencies over the prior
year to USD 1.4 billion. The operating income margin improved by
0.5 percentage points in constant currencies, offset by a negative
currency impact of 0.9 percentage points, resulting in a net
decrease of 0.4 percentage points to 15.0% of net sales. The
constant currency margin improvement was the result of productivity
improvements, the addition of the Falcon business and income from
reduction of a contingent consideration obligation, partly offset
by charges and provisions for legal cases in the US (USD 204
million) as well as price erosion.
Core operating income rose 11% in constant currencies to USD 1.9
billion, as declining prices were more than offset by additional
sales volume, new product launches and productivity improvements in
all areas. Core operating income mar
Posted: January 2012


