FY net sales (0% cc[2]) in line with prior year due to strong Growth Products performance
Cosentyx (USD 1.1 billion) reached blockbuster status
Entresto (USD 170 million) continued to grow steadily, following positive treatment guidelines in US and Europe and ongoing US field force expansion
Gilenya (USD 3.1 billion, +14% cc) delivered double-digit growth
Oncology grew 12% (cc) excluding Gleevec/Glivec, driven by new assets and Jakavi
Sandoz Biopharmaceuticals[1] grew 31% (cc) to reach USD 1.0 billion

FY core[2] operating income down 2% (cc) due to generic erosion and growth investments
Core operating income margin declined 0.7 percentage points (cc)
Core EPS was USD 4.75 (-2% cc)
Free cash flow[2] was USD 9.5 billion (+2% USD)

FY net income up 1% (cc), benefitting from higher income from associated companies
Continued innovation momentum in Q4, including bolt-on deals to further strengthen pipeline
LEE011 granted FDA Priority Review
AMG 334 met primary endpoint in second Phase III episodic migraine study
Exercised right to acquire Selexys following positive SUSTAIN study in sickle cell disease
Acquired Ziarco (atopic dermatitis) and Encore (presbyopia); signed option agreements with Conatus (NASH) and Ionis and Akcea (cardiovascular risk)

Alcon Division continued to make progress toward turnaround; options to maximize shareholder value of the division under consideration
Q4 division sales were flat (cc); contact lenses delivered third consecutive quarter of growth
Supply levels and customer service improved in Surgical, laying foundation for return to growth
Options being considered range from retaining the business to separation via a capital markets transaction; review to take place during the course of 2017

Dividend of CHF 2.75 per share, an increase of 2%, proposed for 2016
Initiating share buyback of up to USD 5.0 billion in 2017 under existing shareholder authority, reinforcing confidence in growth prospects

2017 Outlook
Net sales expected to be broadly in line with the prior year (cc), after absorbing the impact of generic competition
Core operating income expected to be broadly in line with prior year to low single digit decline (cc)

Key figures[2] Continuing operations[3]
Q4 2016 Q4 2015 % change FY 2016 FY 2015 % change
USD m USD m USD cc USD m USD m USD cc
Net sales 12 322 12 520 -2 0 48 518 49 414 -2 0
Operating income 1 455 1 677 -13 -9 8 268 8 977 -8 -3
Net income 936 1 054 -11 0 6 698 7 028 -5 1
EPS (USD) 0.40 0.44 -9 2 2.82 2.92 -3 2
Free cash flow 2 976 2 942 1 9 455 9 259 2
Core
Operating income 3 013 3 057 -1 1 12 987 13 790 -6 -2
Net income 2 658 2 707 -2 1 11 314 12 041 -6 -3
EPS (USD) 1.12 1.14 -2 1 4.75 5.01 -5 -2

[1] Growth Products are defined on page 2. Biopharmaceuticals are defined on page 3.
[2] Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 50 of the Condensed Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year.
[3] Refers to continuing operations, defined on page 41 of the Condensed Financial Report.

On January 25, 2017 Novartis reported solid 2016 performance, with Growth Products[1] absorbing Gleevec US LOE; innovation momentum continued and announced share buyback (Press release, Novartis, JAN 25, 2017, View Source [SID1234517575]).

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Commenting on the results, Joseph Jimenez, CEO of Novartis, said:
"Novartis delivered a solid performance in 2016, absorbing Gleevec US loss of exclusivity while investing in key launches and the Alcon Division turnaround. Cosentyx reached blockbuster status in 2016, and the conditions are now in place for Entresto sales to accelerate in 2017. We made major strides in advancing our pipeline, executing our bolt-on M&A strategy and implementing our new focused organization. Today we are proposing an increase in our dividend and initiating a share buyback of up to USD 5 billion. Additionally, we are reviewing options for the Alcon Division to maximize shareholder value."

GROUP REVIEW

Novartis laid out five priorities for 2016: deliver strong financial results; strengthen innovation; improve Alcon Division performance; capture cross-divisional synergies; and build a higher-performing organization. We are also considering options to maximize shareholder value of the Alcon Division (some additional details on page 8 below).

Financial results

On January 27, 2016, Novartis announced plans to further focus its divisions, integrating businesses that share therapeutic areas to better leverage our development and marketing capabilities. These plans included a new divisional structure. In compliance with International Financial Reporting Standards (IFRS), Novartis updated its segment financials to reflect the new structure, both for the current and prior year, to aid comparability of year-on-year results. As a result, all comparisons of divisional results from 2016 to 2015 reflect the new structure.

In addition, as a result of the portfolio transformation transactions completed in 2015, Novartis reported the Group’s financial results in 2015 as "continuing operations" and "discontinued operations." All comparisons from 2016 to 2015 are versus continuing operations, unless otherwise noted. See page 41 of the Condensed Financial Report for a full explanation.

Fourth quarter

Continuing operations

Net sales were USD 12.3 billion (-2%, 0% cc) in the fourth quarter, as volume growth of 6 percentage points was offset by the negative impact of generic competition (-4 percentage points) and pricing (-2 percentage points). Growth Products[1] contributed USD 4.6 billion or 37% of net sales, up 19% (USD) over the prior-year quarter.

Operating income was USD 1.5 billion (-13%, -9% cc). Core adjustments amounted to USD 1.5 billion (2015: USD 1.4 billion), broadly in line with the prior-year quarter.

Core operating income was USD 3.0 billion (-1%, +1% cc). Core operating income margin in constant currencies increased 0.2 percentage points, as investments behind new launches and the Alcon Division growth plan were more than offset by resource allocation. Currency had a negative impact of 0.1 percentage points, resulting in a net increase of 0.1 percentage points in US dollar terms to 24.5% of net sales.

Net income was USD 0.9 billion (-11%, 0% cc), flat despite the decline in operating income due to higher income from associated companies.

EPS was USD 0.40 (-9%, +2% cc), up more than net income due to a reduction in the average number of shares outstanding.

Core net income was USD 2.7 billion (-2%, +1% cc), broadly in line with core operating income.

Core EPS was USD 1.12 (-2%, +1% cc), in line with core net income.

Free cash flow in the fourth quarter was USD 3.0 billion (+1% USD), broadly in line with the prior-year quarter as lower cash flows from operating activities were offset by lower net investments in property, plant and equipment and intangible assets.

[1] "Growth Products" are an indicator of the rejuvenation of the portfolio, and comprise products launched in a key market (EU, US, Japan) in 2011 or later, or products with exclusivity in key markets until at least 2020 (except Sandoz, which includes only products launched in the last 24 months). They include the acquisition effect of the GSK oncology assets.

Innovative Medicines (formerly named the Pharmaceuticals Division) net sales were USD 8.3 billion (-3%, -1% cc) in the fourth quarter. Volume contributed 6 percentage points to sales growth. Generic competition had a negative impact of 6 percentage points and pricing had a negative impact of 1 percentage point, both largely due to Gleevec/Glivec genericization in the US. Growth Products grew 20% (cc) to USD 4.0 billion, or 48% of division net sales.

Operating income was USD 1.4 billion (-9%, -4% cc), down mainly due to higher impairment charges, which offset underlying operating income growth. Core operating income was USD 2.4 billion (0%, +4% cc). Core operating income margin in constant currencies increased by 1.2 percentage points; currency had a negative impact of 0.5 percentage points, resulting in a net increase of 0.7 percentage points to 29.1% of net sales.

Sandoz net sales were USD 2.6 billion (+2%, +3% cc) in the fourth quarter, as volume growth of 9 percentage points was offset by 6 percentage points of price erosion. Global sales of Biopharmaceuticals[1] grew 28% (cc) to USD 277 million.

Operating income was USD 365 million (+25%, +22% cc), driven by strong operating performance in the quarter and legal provisions in the prior-year quarter. Core operating income was USD 521 million (+5%, +4% cc). Core operating income margin in constant currencies increased by 0.1 percentage points; currency had a positive impact of 0.4 percentage points, resulting in a net increase of 0.5 percentage points to 20.0% of net sales.

Alcon Division net sales were USD 1.4 billion (-2%, 0% cc) in the fourth quarter. Surgical sales (-4% cc) were down, mainly due to lower sales of Cataract and Refractive equipment, as well as competitive pressures in IOLs. Vision Care sales (+5% cc) returned to growth, driven by strong performance of the daily contact lens portfolio, including continued double-digit growth of Dailies Total1 globally.

Operating loss was USD 120 million, compared to an income of USD 29 million in the prior-year quarter. Core operating income was USD 163 million (-38%, -36% cc), impacted by increased investments in M&S and R&D behind the growth plan. Core operating income margin in constant currencies decreased by 6.3 percentage points; currency had a negative impact of 0.4 percentage points, resulting in a net decrease of 6.7 percentage points to 11.3% of net sales.

Total Group

For the total Group, net income amounted to USD 0.9 billion, compared to USD 1.1 billion the prior-year quarter, and basic earnings per share was USD 0.40.

Total Group free cash flow amounted to USD 3.0 billion, in line with the prior-year quarter.

[1] Biopharmaceuticals include biosimilars, biopharmaceutical contract manufacturing and Glatopa.

Full year

Continuing operations

Net sales were USD 48.5 billion (-2%, 0% cc) in the full year, as volume growth of 6 percentage points was offset by the negative impact of generic competition (-4 percentage points) and pricing (-2 percentage points). Growth Products contributed USD 17.1 billion or 35% of net sales, up 20% (USD) over the prior year.

Operating income was USD 8.3 billion (-8%, -3% cc). Core adjustments amounted to USD 4.7 billion (2015: USD 4.8 billion), broadly in line with the prior year.

Core operating income was USD 13.0 billion (-6%, -2% cc). Core operating income margin in constant currencies decreased 0.7 percentage points, mainly due to the loss of exclusivity on Gleevec, as investments behind new launches and the Alcon Division growth plan were partially offset by resource allocation and productivity programs. Currency had a negative impact of 0.4 percentage points, resulting in a net decrease of 1.1 percentage points to 26.8% of net sales.

Net income was USD 6.7 billion (-5%, +1% cc), with the increase relative to the operating income decline due to higher income from associated companies.

EPS was USD 2.82 (-3%, +2% cc), up more than net income due to a reduction in the average number of shares outstanding.

Core net income was USD 11.3 billion (-6%, -3% cc), broadly in line with core operating income.

Core EPS was USD 4.75 (-5%, -2% cc), down less than core net income due to a reduction in the average number of shares outstanding.

Free cash flow was USD 9.5 billion (+2% USD) compared to USD 9.3 billion in 2015. The increase of USD 0.2 billion was mainly driven by lower net investments in property, plant and equipment.

Innovative Medicines net sales were USD 32.6 billion (-2%, 0% cc) for the full year, as volume growth (+7 percentage points) was offset by the impact of generic competition (-6 percentage points) and pricing (-1 percentage point).

Operating income was USD 7.4 billion (-5%, 0% cc). Core operating income was USD 10.4 billion (-5%, -1% cc). Core operating income margin in constant currencies decreased by 0.2 percentage points, mainly due to launch investments for Entresto and Cosentyx, partially offset by resource allocation and productivity improvements; currency had a negative impact of 0.6 percentage points, resulting in a net decrease of 0.8 percentage points to 31.8% of net sales.

Sandoz net sales were USD 10.1 billion (+1%, +2% cc) for the full year, as volume growth of 8 percentage points more than offset 6 percentage points of price erosion. Global sales of Biopharmaceuticals grew 31% (cc) to reach USD 1.0 billion, benefitting from the performance of prior-year launches in the US (Glatopa in June 2015 and Zarxio in September 2015).

Operating income was USD 1.4 billion (+11%, +14% cc). Core operating income was USD 2.1 billion (+1%, +4% cc). Core operating income margin in constant currencies increased by 0.2 percentage points; currency had a negative impact of 0.1 percentage points, resulting in a net increase of 0.1 percentage points to 20.4% of net sales.

Alcon Division net sales were USD 5.8 billion (-3%, -2% cc) for the full year. Surgical sales (-3% cc) reflected lower sales of Cataract and Refractive equipment, as well as competitive pressures in IOLs, partially offset by continued solid growth of cataract consumables. Vision Care sales were flat (0% cc), with growth in contact lenses offsetting a decline in contact lens care.

Operating loss was USD 132 million, compared to an income of USD 281 million in the prior year. Core operating income was USD 850 million (-31%, -27% cc), impacted by increased investments in M&S and R&D behind the growth plan and the decline in sales. Core operating income margin in constant currencies decreased by 5.3 percentage points; currency had a negative impact of 0.7 percentage points, resulting in a net decrease of 6.0 percentage points to 14.6% of net sales.

Total Group

For the total Group, net income amounted to USD 6.7 billion compared to USD 17.8 billion in the prior year, and basic earnings per share decreased to USD 2.82 from USD 7.40. The prior year benefitted from the net income from discontinued operations, which included USD 12.7 billion of exceptional pre-tax divestment gains from the portfolio transformation transactions and USD 0.6 billion of additional pre-tax transaction related expenses.

Total Group free cash flow amounted to USD 9.5 billion in 2016 compared to USD 9.0 billion in 2015. The prior year included a negative free cash flow of approximately USD 0.3 billion from discontinued operations.

Key growth drivers

Underpinning our financial results in the fourth quarter is a continued focus on key growth drivers, including Gilenya, Tasigna, Cosentyx, Tafinlar + Mekinist, Promacta/Revolade, Jakavi and Entresto, as well as Biopharmaceuticals and Emerging Growth Markets.

Growth Products

Growth Products, an indicator of the ongoing rejuvenation of our portfolio, contributed 37% of Group net sales in the fourth quarter, and were up 19% (USD). In Innovative Medicines, Growth Products contributed 48% of division net sales in the quarter, and sales for these products were up 20% (cc).
Gilenya (USD 810 million, +11% cc), a once-daily oral medicine for relapsing forms of multiple sclerosis, continued to grow double-digit.
Tasigna (USD 458 million, +9% cc) showed solid growth in the quarter, despite the entry of multiple generic versions of Gleevec in the US.
Cosentyx (USD 391 million) continued its strong launch trajectory in the fourth quarter. Across its three approved indications, Cosentyx has been used to treat more than 60,000 patients in a post-marketing setting to date.
Tafinlar + Mekinist (USD 178 million, +24% cc) continued to show strong growth, particularly in Europe, as the first approved combination therapy for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.
Promacta/Revolade (USD 178 million, +35% cc) grew at a strong double-digit rate, driven by continued worldwide uptake as well as growth of the thrombopoietin class for chronic immune (idiopathic) thrombocytopenic purpura.
Jakavi (USD 162 million, +40% cc) growth was driven by patient gains in the myelofibrosis indication globally and the launch of the polycythemia vera indication in key markets.
Entresto (USD 68 million) continued to grow steadily with approvals in more than 70 countries to date and continued progress with reimbursement around the world. With positive treatment guidelines, ongoing field force expansion and removal of access restrictions in the US, we are well placed to triple TRx volume for Entresto in the US by Q4 2017.
Sandoz Biopharmaceuticals (USD 277 million, +28% cc), including Glatopa and Zarxio, delivered another quarter of strong growth to reach USD 1.0 billion in sales for the full year.
Emerging Growth Markets

Net sales in Emerging Growth Markets – which comprise all markets except the US, Canada, Western Europe, Japan, Australia and New Zealand – grew 4% (cc) in the fourth quarter, led by China (+9% cc), Russia (+11% cc) and Turkey (+16% cc).
Strengthen innovation

The fourth quarter saw pipeline progress with positive regulatory decisions, significant clinical trial data and business development activity announced. Key developments are included below.

New approvals and regulatory opinions

Lucentis (ranibizumab) received EU approval to treat patients with visual impairment due to rare conditions causing choroidal neovascularization (CNV).
The EC approved Arzerra (ofatumumab) in combination with fludarabine and cyclophosphamide for the treatment of adult patients with relapsed chronic lymphocytic leukemia.
Votubia (everolimus) was recommended by CHMP for approval as an adjunctive treatment for patients aged two years and older whose refractory partial-onset seizures, with or without secondary generalization, are associated with tuberous sclerosis complex (TSC).
The CHMP recommended the approval of Ilaris (canakinumab) to treat three rare and distinct Periodic Fever Syndromes. The Japanese Ministry of Health, Labour and Welfare (MHLW) approved Ilaris for the same indications.
Alcon Division’s AcrySof IQ ReSTOR +3.0D Multifocal Toric IOL was approved in the US.
Alcon Division’s AcrySof IQ PanOptix Toric IOL received EU approval to provide improved near, intermediate and distance vision for cataract patients with astigmatism.
Regulatory submissions and filings

The FDA granted Priority Review to LEE011 (ribociclib) in combination with letrozole as first-line treatment for postmenopausal women with HR+/HER2- advanced or metastatic breast cancer. The EMA also accepted for review our application for LEE011 plus letrozole in the same patient population.
The FDA granted Priority Review to Tafinlar + Mekinist (dabrafenib + trametinib) combination therapy for the treatment of BRAF mutant non-small cell lung cancer (NSCLC).
The FDA granted Priority Review to PKC412 (midostaurin) for the treatment of newly diagnosed FLT3 mutation-positive acute myeloid leukemia and advanced systemic mastocytosis.
Applications were submitted in the US, EU, Japan and other markets to expand the indication for Zykadia (ceritinib) as a first-line treatment for patients with ALK+ NSCLC.
BACE inhibitor CNP520 received FDA Fast Track designation. CNP520 is being co-developed with Amgen.
Results from important clinical trials and other highlights

New data showed that Cosentyx (secukinumab) delivered sustained improvements in the signs and symptoms of psoriatic arthritis over three years.
The Phase III STRIVE study in episodic migraine prevention met its primary endpoint, with AMG 334 (erenumab) demonstrating a statistically significant reduction from baseline in mean monthly migraine days at six months versus placebo. AMG 334 is being co-developed by Novartis and Amgen. Novartis has commercial rights to AMG 334 outside of the US, Canada and Japan.
A post-hoc analysis of PARADIGM-HF data showed that Entresto (sacubitril/valsartan) reduced the risk of first and repeat heart failure hospitalizations as well as cardiovascular deaths by 20-24% compared to enalapril.
Additional analyses from the Phase III MONALEESA-2 study showed that LEE011 plus letrozole significantly prolonged PFS across various pre-planned patient subgroups with HR+/HER2- advanced or metastatic breast cancer, including post-menopausal women diagnosed de novo, those with visceral metastases, and those with bone-only disease.
Two Phase III studies of pegpleranib, sponsored by Ophthotech, did not meet their primary endpoints. The studies showed that the proven efficacy of Lucentis (ranibizumab) monotherapy was not improved by the addition of pegpleranib.
Results from the pivotal global Phase II ELIANA trial of CTL019 in relapsed/refractory pediatric and young adult patients with B-cell acute lymphoblastic leukemia found that 82% of infused patients achieved complete remission or complete remission with incomplete blood count recovery at three months post CTL019 infusion.
Results from the Phase III ASCEND-4 study showed patients with ALK+ NSCLC treated with first-line Zykadia had a median PFS of 16.6 months, compared to 8.1 months in patients treated with standard first-line chemotherapy with maintenance.
Novartis exercised its right to acquire Selexys following the positive Phase II SUSTAIN study, which showed that SEG101 (crizanlizumab) reduced the median annual rate of sickle cell-related pain crises compared to placebo in patients with or without hydroxyurea therapy.
The Global Initiative for Chronic Lung Disease (GOLD) released updated guidelines for the management of COPD, recommending first-line treatment with a LABA/LAMA drug, such as Ultibro Breezhaler (indacaterol/glycopyrronium), for the majority of symptomatic COPD patients regardless of exacerbation risk.
New data from two head-to-head studies showed Utibron Neohaler provided clinically meaningful and comparable bronchodilation to Anoro Ellipta in US patients with COPD, though the primary endpoint of non-inferiority was not met. Novartis out-licensed US commercialization rights for Utibron Neohaler, as well as Seebri Neohaler and Arcapta Neohaler, to Sunovion.
Novartis acquired Ziarco, adding a once-daily oral H4 receptor antagonist in development for atopic dermatitis to our growing dermatology portfolio and pipeline.
Novartis signed an exclusive option, collaboration and license agreement with Conatus, which will allow the companies to jointly develop emricasan for the treatment of non-alcoholic steatohepatitis (NASH) with advanced fibrosis and cirrhosis.
Novartis acquired Encore Vision, adding a first-in-class disease modifying topical treatment for presbyopia to our ophthalmology pipeline.
In January, Novartis entered into an exclusive option agreement with Ionis and Akcea to license two investigational treatments expected to significantly reduce cardiovascular risk in patients living with elevated levels of lipoprotein Lp(a) or ApoCIII. This transaction is subject to customary closing conditions, including regulatory approval.
The ASSIST-FL trial met its primary endpoint, with Sandoz biosimilar rituximab demonstrating equivalent efficacy in addition to safety, pharmacokinetics and pharmacodynamics to the reference product, MabThera.
Data from the EGALITY trial showed that there are no clinically meaningful differences between Sandoz biosimilar etanercept and the reference product Enbrel in safety and efficacy over 52 weeks.
Improve Alcon Division performance

The Alcon Division continued to execute against its growth plan in the fourth quarter, taking actions to accelerate innovation and sales, strengthen customer relationships and improve basic operations.

In Vision Care (Q4 sales growth of 5% cc), the Alcon Division continued investments in DTC advertising behind key brands in Europe and the US, which helped drive growth in contact lenses for the third consecutive quarter.

In Surgical (Q4 sales decline of 4% cc), the Alcon Division continued to strengthen its basic operations and improve supply levels, which led to improved customer service. With its supply issues largely resolved, the division is in a better position to defend against competitive pressure and drive a return to growth. The Alcon Division continued to advance its pipeline in the fourth quarter, with two new approvals for IOLs: the AcrySof IQ ReSTOR +3.0D Multifocal Toric in the US and AcrySof IQ PanOptix Toric in the EU. The division also invested in expanding its new product launches, including CyPass and NGENUITY 3D.

Options to Maximize Shareholder Value of the Alcon Division under Consideration

Novartis is considering options for the Alcon Division. The review will explore all options, ranging from retaining the business to separation via a capital markets transaction (e.g. IPO or spin-off), in order to determine how to best maximize value for our shareholders. The review will be conducted during the course of 2017 and in a manner such that Alcon Division associates can fully focus on the unit’s return to growth.

The Alcon Division comprises leading surgical and vision care (contact lens and lens care solution) businesses, both of which are leaders in their respective segments. Novartis believes that the Alcon Division is a highly attractive business, with a strong customer base and led by a strong management team. Novartis is exploring whether there are additional value-maximizing opportunities for the Alcon Division as an independent company or otherwise.

The ophthalmic pharmaceutical portfolio is now fully integrated into our Innovative Medicines Division and will not be part of the review announced today.

Novartis expects to provide a status update on the review towards the end of 2017.

Capture cross-divisional synergies

We continued to advance our productivity programs in the fourth quarter, helping to support margins for the Group.

Novartis Business Services (NBS), our cross-divisional services organization, continued to leverage the global scale of Novartis to streamline and consolidate our operations. The costs within the scope of NBS decreased compared to the prior year, while the quality of services improved. For example, we initiated the standardization of infrastructure services at selected manufacturing sites and continued to consolidate facilities services from more than 100 suppliers to just three as well as reduce the number of information technology applications we use, among other steps. In addition, NBS continued to optimize its geographical footprint to our five global service centers.
Novartis Technical Operations completed the organizational integration of the six technology platforms, including a more efficient utilization of functional capabilities and resources. A synergy and savings roadmap has been established with a five-year time horizon based on three pillars: optimization of capacity utilization, external spend and operational excellence.
In the fourth quarter of 2016, Novartis completed the creation of its new Global Drug Development (GDD) organization to oversee drug development across the innovative medicines and biosimilars portfolio. The enterprise-wide approach to portfolio management – a core tenet of GDD – has already enabled us to fund several new confirmatory development projects without increasing the total development spend. Additionally, the integration of all global development functions has enabled more flexible use of resources across the portfolio and provided a strong platform for accelerated implementation of major technology projects designed to further improve the quality and efficiency of our development operations.
Build a higher-performing organization

Novartis continues to proactively drive compliance, reliable product quality and sustainable efficiency as part of the quality strategy. A total of 206 global health authority inspections were completed in 2016 (79 in Q4), 26 of which were conducted by the FDA (9 in Q4). All but four out of 206 inspections were deemed good or acceptable. We received the outcome of the fourth inspection not deemed good or acceptable in the fourth quarter. It pertained to an EMA inspection of a Sandoz site in Germany as the sponsor of a clinical trial. Corrective and preventative actions to address all observations have been defined and are being implemented.

Capital structure and net debt

Retaining a good balance between investment in the business, a strong capital structure and attractive shareholder returns remains a priority.

As a sign of confidence in the growth prospects of Novartis, we are initiating a share buyback of up to USD 5.0 billion under the existing authority of the seventh share buyback framework granted by the AGM in February 2016. Novartis aims to execute the buyback during 2017 and plans to finance it through new debt, demonstrating its willingness to actively use its strong balance sheet in the current environment of historically low interest rates.

During 2016, 13.1 million treasury shares were delivered as a result of options exercised and share deliveries related to equity-based participation plans of associates. To offset the dilutive impact of such transactions, 12.9 million Novartis shares were repurchased on the SIX Swiss Exchange second trading line and from employees.

Also, during 2016, Novartis issued two euro denominated bonds for a total amount of USD 2.0 billion. A euro denominated bond issued in 2009 for a total amount of USD 1.7 billion was repaid in the second quarter at maturity.

Net debt decreased to USD 16.0 billion at December 31, 2016 from USD 16.5 billion at December 31, 2015, as the free cash flow of USD 9.5 billion was mainly used for the annual dividend payment of USD 6.5 billion, acquisition and divestments related payments of USD 1.5 billion and net purchases of treasury shares of USD 0.9 billion.

The long-term credit rating for the company continues to be double-A (Moody’s Aa3; Standard & Poor’s AA-; Fitch AA).

2017 Outlook

Barring unforeseen events

Group net sales in 2017 are expected to be broadly in line with the prior year (cc), after absorbing the impact of generic competition, including the continued genericization of Gleevec/Glivec in the US and Europe. The impact of generic competition on sales is expected to be approximately USD 2.5 billion in 2017.

From a divisional perspective, we expect net sales performance (cc) in 2017 to be as follows:

Innovative Medicines: broadly in line with prior year
Sandoz: low single digit growth
Alcon Division: broadly in line with prior year to low single digit growth
Group core operating income in 2017 is expected to be broadly in line with prior year to a low single digit decline (cc).

If mid-January exchange rates prevail for the remainder of 2017, the currency impact for the year would be negative 2 percentage points on sales and negative 3 percentage points on core operating income. The estimated impact of exchange rates on our results is provided monthly on our website.

Annual General Meeting

Dividend proposal
The Novartis Board of Directors proposes a dividend payment of CHF 2.75 per share for 2016, up 2% from CHF 2.70 per share in 2015, representing the 20th consecutive dividend increase since the creation of Novartis in December 1996. Shareholders will vote on this proposal at the 2017 Annual General Meeting of Shareholders to be held on February 28, 2017.

Nomination for election to the Board of Directors
The Novartis Board of Directors announced today that it is nominating Mr. Frans van Houten for election to the Board at the 2017 Annual General Meeting.

Mr. van Houten is CEO and Chairman of the Executive Committee and the Board of Management of health technology leader Royal Philips, a position he took up in 2011. He held multiple senior global leadership positions across Philips on three continents, including co-CEO of the Consumer Electronics division and CEO of the successful Philips spin-off NXP Semiconductors. With his many years as a leader in the IT, consumer health and medical technology industries, Mr. van Houten will deepen the Board’s expertise in digital health solutions.

Re-elections of the Chairman and the members of the Board of Directors
The Novartis Board of Directors proposes the re-election of Joerg Reinhardt, Ph.D. (also as Chairman of the Board of Directors), Nancy C. Andrews, M.D., Ph.D., Dimitri Azar, M.D., MBA, Ton Buechner, Srikant Datar, Ph.D., Elizabeth Doherty, Ann Fudge, Pierre Landolt, Ph.D., Andreas von Planta, Ph.D., Charles L. Sawyers, M.D., Enrico Vanni, Ph.D., and William T. Winters as member of the Board of Directors, each until the 2018 Annual General Meeting.

Re-elections and election to the Compensation Committee
The Novartis Board of Directors proposes the re-election of Srikant Datar, Ph.D., Ann Fudge, Enrico Vanni, Ph.D., and William T. Winters as members of the Compensation Committee, each until the 2018 Annual General Meeting.

Summary Financial Performance
Continuing operations[1] Q4 2016 Q4 2015 % change FY 2016 FY 2015 % change
USD m USD m USD cc USD m USD m USD cc
Net sales 12 322 12 520 -2 0 48 518 49 414 -2 0
Operating income 1 455 1 677 -13 -9 8 268 8 977 -8 -3
As a % of sales 11.8 13.4 17.0 18.2
Core operating income 3 013 3 057 -1 1 12 987 13 790 -6 -2
As a % of sales 24.5 24.4 26.8 27.9
Net income 936 1 054 -11 0 6 698 7 028 -5 1
EPS (USD) 0.40 0.44 -9 2 2.82 2.92 -3 2
Free cash flow 2 976 2 942 1 9 455 9 259 2
Innovative Medicines Q4 2016 Q4 2015[2] % change FY 2016 FY 2015[2] % change
USD m USD m USD cc USD m USD m USD cc
Net sales 8 273 8 498 -3 -1 32 562 33 345 -2 0
Operating income 1 360 1 499 -9 -4 7 426 7 815 -5 0
As a % of sales 16.4 17.6 22.8 23.4
Core operating income 2 407 2 411 0 4 10 354 10 862 -5 -1
As a % of sales 29.1 28.4 31.8 32.6
Sandoz Q4 2016 Q4 2015[2] % change FY 2016 FY 2015[2] % change
USD m USD m USD cc USD m USD m USD cc
Net sales 2 605 2 554 2 3 10 144 10 070 1 2
Operating income 365 291 25 22 1 445 1 300 11 14
As a % of sales 14.0 11.4 14.2 12.9
Core operating income 521 497 5 4 2 071 2 045 1 4
As a % of sales 20.0 19.5 20.4 20.3
Alcon Q4 2016 Q4 2015[2] % change FY 2016 FY 2015[2] % change
USD m USD m USD cc USD m USD m USD cc
Net sales 1 444 1 468 -2 0 5 812 5 999 -3 -2
Operating loss/income -120 29 nm nm -132 281 nm nm
As a % of sales -8.3 2.0 -2.3 4.7
Core operating income 163 264 -38 -36 850 1 235 -31 -27
As a % of sales 11.3 18.0 14.6 20.6
Corporate Q4 2016 Q4 2015 % change FY 2016 FY 2015 % change
USD m USD m USD cc USD m USD m USD cc
Operating loss -150 -142 -6 -14 -471 -419 -12 -25
Core operating loss -78 -115 32 22 -288 -352 18 4
Discontinued operations Q4 2016 Q4 2015 % change FY 2016 FY 2015 % change
USD m USD m USD cc USD m USD m USD cc
Net sales 0 601
Operating loss/income -94 12 477
As a % of sales nm nm
Core operating loss -2 -225
As a % of sales nm nm
Total Group[3] Q4 2016 Q4 2015 % change FY 2016 FYM 2015 % change
USD m USD m USD cc USD m USD m USD cc
Net income 936 1 056 -11 -1 6 698 17 794 -62 -59
EPS (USD) 0.40 0.44 -9 2 2.82 7.40 -62 -59
Free cash flow 2 976 3 002 -1 9 455 9 029 5
nm= not meaningful

[1] Continuing operations include the businesses of Innovative Medicines (formerly named the Pharmaceuticals Division), the Alcon Division, Sandoz and Corporate activities, and starting on March 2, 2015, the results from the new oncology assets acquired from GSK and the 36.5% interest in the GSK Consumer Healthcare Holdings Ltd. (the latter reported as part of income from associated companies). See page 41 of the Condensed Financial Report for full explanation.
[2] In compliance with IFRS, Novartis updated its segment financials to reflect the new divisional structure announced on January 27, 2016, to aid comparability of year-on-year results.
[3] Total Group net income and EPS include in the prior year the impact of the exceptional divestment gains and the operating results of the discontinued operations. Total Group free cash flow comprises the free cash flow from continuing operations and discontinued operations.

A condensed financial report with the information listed in the index below can be found on our website at View Source (link is external).

Novartis Q4 and FY 2016 Condensed Financial Report – Supplementary Data

INDEX Page
GROUP AND DIVISIONAL OPERATING PERFORMANCE Q4 and FY 2016
Group 2
Innovative Medicines 6
Sandoz 15
Alcon 17
CASH FLOW AND GROUP BALANCE SHEET 20
INNOVATION REVIEW 23
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Condensed consolidated income statements 31
Condensed consolidated statements of comprehensive income 33
Condensed consolidated balance sheets 34
Condensed consolidated changes in equity 35
Condensed consolidated cash flow statements 36
Notes to condensed consolidated financial statements, including update on legal proceedings 38
SUPPLEMENTARY INFORMATION 50
CORE RESULTS
Reconciliation from IFRS to core results 52
Group 54
Innovative Medicines 56
Sandoz 58
Alcon 60
Corporate 62
Discontinued operations 64
ADDITIONAL INFORMATION
Condensed consolidated changes in net debt / Share information 65
Free cash flow 66
Net sales of the top 20 Innovative Medicines products 67
Innovative Medicines sales by business franchise 69
Net sales by region 71
Currency translation rates 73
Income from associated companies 74
DISCLAIMER 75

On January 25, 2017 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported the opening of enrollment of a Phase II study of VAL-083 at the University of Texas MD Anderson Cancer Center in Houston, Texas (Press release, DelMar Pharmaceuticals, JAN 25, 2017, View Source [SID1234517555]).

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DelMar Pharmaceuticals Logo (PRNewsFoto/DelMar Pharmaceuticals, Inc.)
The Phase II study of VAL-083 (dianhydrogalactitol) in patients with MGMT-unmethylated, Avastin (bevacizumab)-naïve recurrent glioblastoma will enroll 48 patients in a single-arm design to determine if treatment with VAL-083 improves overall survival, compared to historical control. Further information regarding the clinical trial can be found on DelMar’s website and at clinicaltrials.gov (clinicaltrials.gov identifier: NCT02717962).

"This study is a keystone in our strategy to expand the development of VAL-083 to target MGMT-unmethylated GBM, a significant unmet medical need," said Jeffrey Bacha, chairman & CEO of DelMar Pharmaceuticals. "We are pleased to launch this important trial in collaboration with the University of Texas MD Anderson Cancer Center, one of the world’s most respected medical centers devoted exclusively to cancer patient care, research, education and prevention."

Approximately two-thirds of newly diagnosed GBM patients have tumors with an unmethylated MGMT promoter, which is correlated with high expression of the DNA repair enzyme, MGMT. Published studies have documented that expression of MGMT is an important factor in predicting the outcome of GBM patients treated with alkylating agents such as temozolomide (TMZ), carmustine (BCNU), and lomustine (CCNU).

Patients whose tumors exhibit high expression of MGMT have a poor prognosis and significantly shorter progression free survival (PFS) and overall survival (OS) in comparison to patients with a methylated MGMT promoter and low MGMT expression. In a 2011 study of more than 800 GBM patients, those with tumors carrying the unmethylated MGMT promoter had a median overall survival of 14 months versus 21 months for those with a methylated MGMT promoter. The difference in progression-free survival – the period after treatment during which the cancer does not worsen – was 5.7 and 8.7 months, respectively.

About VAL-083

VAL-083 is a "first-in-class," small-molecule chemotherapeutic that demonstrated clinical activity against a range of cancers including GBM in historical clinical trials sponsored by the U.S. National Cancer Institutes. DelMar has demonstrated that VAL-083’s anti-tumor activity against GBM is unaffected by the expression of MGMT in vitro. Further details can be found at View Source

VAL-083 has received an orphan drug designation in Europe for the treatment of malignant gliomas and the U.S. FDA Office of Orphan Products has granted an orphan designation to VAL-083 for the treatment of glioma, medulloblastoma and ovarian cancer.

DelMar has also announced plans to advance VAL-083 into a pivotal randomized multi-center Phase III clinical trial for the treatment of bevacizumab-failed GBM and into a separate international Phase II trial for newly diagnosed GBM patients with an unmethylated MGMT promoter.

"We believe that data from these upcoming clinical trials, if successful, will form the basis of a new treatment paradigm for the vast majority of GBM patients whose tumors exhibit features that make them unlikely to respond to currently available chemotherapy," added Mr. Bacha.

"Our data demonstrating that VAL-083’s activity against GBM is independent of MGMT expression combined with VAL-083’s established clinical activity against GBM from published NCI-sponsored clinical studies provides confidence to our hope that VAL-083 will give doctors and their patients a new and unique chemotherapy to address this enormous global unmet medical need."

About Glioblastoma Multiforme (GBM)

GBM is the most common and the most lethal form of glioma. Approximately 15,000 new cases of GBM are expected to be diagnosed in the United States during 2017. GBM progresses quickly and patients deteriorate rapidly. Common symptoms include headaches, seizures, nausea, weakness, paralysis and personality or cognitive changes such as loss of speech or difficulty in thinking clearly. The majority of GBM patients do not survive for more than two years following diagnosis, and the median survival in newly diagnosed patients with best available treatments is less than 15 months.

On January 25, 2017 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that a Phase III clinical trial (Study 304) of its in-house discovered and developed anticancer agent Lenvima (lenvatinib mesylate, "lenvatinib") against the comparator sorafenib as a first-line treatment for patients with unresectable hepatocellular carcinoma has achieved its primary endpoint (Press release, Eisai, JAN 25, 2017, View Source [SID1234517544]).

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Study 304 is a multicenter, randomized, open-label, global Phase III study comparing the efficacy and safety of lenvatinib versus sorafenib, a standard treatment for advanced hepatocellular carcinoma, as a first-line treatment for patients with unresectable hepatocellular carcinoma. In the study, 954 patients were randomized in a 1:1 ratio to receive lenvatinib 12 mg or 8 mg once a day, depending on baseline body weight (n= 478) or sorafenib 400 mg twice a day (n= 476). Treatment was continued until disease progression or unacceptable toxicity.
The primary endpoint of the study was overall survival (OS), with the goal of demonstrating non-inferiority. Other factors including progression free survival (PFS), time to progression (TTP) and objective response rate (ORR) were assessed as secondary endpoints.

According to the results of the study, lenvatinib met the statistical criteria for non-inferiority of OS compared to sorafenib, and showed statistically significant and clinically meaningful improvement for PFS, TTP and ORR. In this study, the five most common adverse events observed in the lenvatinib arm were hypertension, diarrhea, decreased appetite, weight loss and fatigue, which is consistent with the known side-effect profile of lenvatinib. Analyses of the remaining secondary endpoints of quality of life and plasma PK parameters as well as safety are ongoing.

Eisai plans to hold discussions with regulatory authorities for submission in Japan, the United States, Europe and Asia, including China. Eisai will also present the details at an upcoming academic conference.

Liver cancer is the second leading cause of cancer related deaths, and is estimated to be responsible for approximately 700,000 deaths per year in the world1. The majority of cases occur in Asia, including China, and Africa. Hepatocellular carcinoma accounts for 85% to 90% of primary liver cancer cases. Early stage hepatocellular carcinoma is treatable by a wide variety of means, including surgery, radiofrequency ablation, ethanol injection, chemoembolization therapy, but treatment opinions for unresectable hepatocellular carcinoma are limited and the prognosis is very poor, meaning that this is an area of high unmet medical need.

Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai remains committed to providing further clinical evidence for lenvatinib aimed at maximizing value of the drug as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.