novartis ag-sponsored adr (NVS) Key Developments
Novartis AG Announces Earnings Results from Continuing Operations Results and Group Results for the First Quarter Ended March 31, 2015; Provides Earnings Guidance for Full Year 2015
Apr 23 15
Novartis AG announced earnings results from continuing operations results and group results for the first quarter ended March 31, 2015. For the quarter, from continuing operations the company reported net sales of USD 11,935 million against USD 12,767 million a year ago. Operating income was USD 2,785 million against USD 2,815 million a year ago. Net income was USD 2,306 million or USD 0.96 per share against USD 2,454 million or USD 0.99 per share a year ago. Free cash flow was USD 1,465 million against USD 1,152 million a year ago. Core operating income was USD 3,651 million against USD 3,800 million a year ago. Core net income was USD 3,199 million or USD 1.33 per share against USD 3,333 million or USD 1.35 per share a year ago. Continuing operations net income was growing less than operating income mainly due to a lower contribution from associated companies, partly offset by lower financial expenses. EPS was growing ahead of net income due to the lower number of average outstanding shares. Free cash flow was increased by USD 0.3 billion compared to the prior-year period. This was primarily due to hedging gains and lower net working capital, partially offset by a negative currency impact on operations As of March 31, 2015, the net debt stood at USD 17.8 billion compared to USD 6.5 billion at December 31, 2014. The increase of USD 11.3 billion was driven by the outflows from the acquisition of oncology net assets from GSK of USD 16.0 billion
For the quarter, the company reported total group results that net sales were USD 12,483 million against USD 14,022 million a year ago. Operating income was USD 15,407 million against USD 3,489 million a year ago. Net income was USD 13,005 million or USD 5.40 per share against USD 2,968 million or USD 1.21 per share a year ago. Free cash flow was USD 1,226 million against USD 765 million a year ago. Core operating income was USD 3,549 million against USD 3,657 million a year ago. Core net income was USD 3,116 million or USD 1.29 per share against USD 3,212 million or USD 1.31 per share a year ago.
The company's outlook for full year 2015 remains unchanged. Group net sales in 2015 are expected to grow mid-single digit (cc), after absorbing the impact of generic competition, which is expected to be as much as USD 2.5 billion compared to USD 2.4 billion in 2014. Group core operating income is expected to grow ahead of sales at a high-single digit rate (cc) in 2015.
Novartis Looking For Bolt-On Acquisitions Worth $2-5 Billion
Apr 23 15
Joseph Jimenez, Chief Executive Officer of Novartis AG (SWX:NOVN) announced that the company is on the lookout for bolt-on acquisitions worth $2-5 billion.
Novartis Announces New Analysis from the Phase III Freedoms and Freedoms II Trials
Apr 21 15
Novartis announced new analysis from the phase III FREEDOMS and FREEDOMS II trials presented at the 67th American Academy of Neurology Annual Meeting in Washington, DC, USA. These data showed that previously-treated patients with highly-active relapsing multiple sclerosis (RMS) who were treated with Gilenya (fingolimod) had a six-times greater likelihood of achieving 'no evidence of disease activity' across four key measures of disease activity compared to placebo over two years (odds ratio 6.35; 95% CI 3.02-13.35; p<0.0001). This is referred to as NEDA4 and is achieved when a patient with RMS has no relapses, no new MRI lesions, no MS-related brain shrinkage and no disability progression. This analysis was the first time patients with highly-active RMS who had been treated in the previous year with an inject able therapy were assessed using the NEDA4 definition that includes brain shrinkage. Brain shrinkage is a marker of the widespread inflammatory (diffuse) damage in the central nervous system and is associated with accumulated loss of function. By using this updated NEDA4 definition, physicians are able to get a more complete picture of a patient's disease and response to treatment, which is crucial to identify the optimal therapy to slow short- and long-term disease progression. This is especially important for people with highly-active RMS, who are at a greater risk of relapses and future loss of function, and may therefore require a different treatment approach. Separate analysis from the entire phase III TRANSFORMS study also confirmed that after one year of treatment, RMS patients on Gilenya were twice as likely to achieve NEDA4 compared to patients given Avonex - interferon beta-1a i.m. injections (odds ratio 1.93; 95% CI 1.36-2.73; p=0.0002). The data provide further evidence of how Gilenya helps RMS patients achieve NEDA4 across four key measures of disease activity.
Federal Trade Commission Approves Final Order Preserving Competition in Market for Braf- and Mek-Inhibitor Oncology Drugs
Apr 8 15
Following a public comment period, the Federal Trade Commission has approved a final order settling charges that Novartis AG's $16 billion acquisition of GlaxoSmithKline's portfolio of cancer-treatment drugs likely would be anticompetitive. Under the order, first announced in February 2015, Novartis has agreed to divest all assets related to its BRAF- and MEK-inhibitor drugs, currently in development, to Boulder, Colorado-based Array BioPharma. The Commission vote approving the final order was 5-0.
Novartis AG Announces FDA Approval for Jadenu to Simplify Treatment Administration for Patients with Chronic Iron Overload
Mar 31 15
Novartis announced that the US Food and Drug Administration (FDA) has approved Jadenu (deferasirox) tablets, a new oral formulation of Exjade (deferasirox) tablets for oral suspension, for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older, and chronic iron overload in non-transfusion-dependent thalassemia syndromes (NTDT) in patients 10 years of age and older. Jadenu is the only once-daily oral iron chelator that can be swallowed whole. Many patients with myelodysplastic syndromes, sickle cell disease or thalassemia need repeated blood transfusions and consequently, long-term daily chelation therapy. Jadenu oral tablets can be taken in a single step, with or without a light meal, simplifying administration of treatment for chronic iron overload. Exjade is a dispersible tablet that must be mixed in liquid and taken on an empty stomach. Jadenu is approved under accelerated approval based on a reduction of liver iron concentrations and serum ferritin levels. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Chronic iron overload is a life-threatening cumulative toxicity that results from blood transfusions required to treat sickle cell disease, myelodysplastic syndromes, thalassemia and other conditions. Chronic iron overload also can occur in patients with NTDT due to increased iron absorption in the stomach and intestines. If left untreated, chronic iron overload can damage the liver and heart.