novartis ag-sponsored adr (NVS) Key Developments
Novartis AG Reports Unaudited Consolidated Earnings Results for the Second Quarter and First Half Ended June 30, 2015; Reiterates Earnings Guidance for the Full Year 2015
Jul 21 15
Novartis AG reported unaudited consolidated earnings results for the second quarter and first half ended June 30, 2015. For the quarter, the company's net sales from continuing operations were $12,694 million compared with $13,411 million a year ago. Operating income from continuing operations was $2,281 million compared with $3,184 million a year ago. This was mainly due to the amortization of the new oncology assets as well as a commercial settlement gain related to intellectual property in the prior-year period, partly offset by strong operating performance. Income before taxes from continuing operations was $2,156 million compared with $3,147 million a year ago. Net income from continuing operations was $1,856 million or $0.76 per diluted share compared with $2,723 million or $1.09 per diluted share a year ago. Net income attributable to shareholders of the company was $1,836 million or $0.75 per diluted share compared with $2,555 million or $1.03 per diluted share a year ago. Total cash flows from operating activities were $2,910 million compared with $3,341 million a year ago. Purchase of property, plant & equipment was $566 million compared with $644 million a year ago. Purchase of intangible, financial and other non-current assets was $476 million compared with $318 million a year ago. Core operating income from continuing operations was $3,593 million compared with $3,859 million a year ago. Core net income from continuing operations was $3,074 million or $1.27 per share compared with $3,335 million or $1.36 per share a year ago. This was due to the lower number of average outstanding shares. Core net income attributable to shareholders of the company was $3,013 million or $1.25 per share compared with $3,253 million or $1.34 per share a year ago. As on June 30, 2015, the company's net debt was $17,399 million.
For the six months, the company's net sales from continuing operations were $24,655 million compared with $26,243 million a year ago. Operating income from continuing operations was $5,066 million compared with $5,999 million a year ago. This was mainly due to the amortization of the new oncology assets as well as a commercial settlement gain related to intellectual property in the prior-year period, mostly offset by strong operating performance. Income before taxes from continuing operations was $4,834 million compared with $5,984 million a year ago. Net income from continuing operations was $4,162 million or $1.70 per diluted share compared with $5,177 million or $2.07 per diluted share a year ago. Net income attributable to shareholders of the company was $14,841 million or $6.06 per diluted share compared with $5,496 million or $2.22 per diluted share a year ago. Total cash flows from operating activities were $4,614 million compared with $4,681 million a year ago. Purchase of property, plant & equipment was $1,035 million compared with $1,126 million a year ago. Purchase of intangible, financial and other non-current assets was $722 million compared with $444 million a year ago. Core operating income from continuing operations was $7,244 million compared with $7,659 million a year ago. Core net income from continuing operations was $6,273 million or $2.60 per share compared with $6,668 million or $2.71 per share a year ago. This was due to the lower number of average outstanding shares. Core net income attributable to shareholders of the company was $6,129 million or $2.54 per share compared with $6,438 million or $2.64 per share a year ago.
Despite the weaker second-quarter performance, the company reiterated its full-year 2015 guidance. Net sales are still expected to grow in the mid-single digit percentage range at constant exchange rates in the full 2015. Core operating profit is projected to grow ahead of sales at a high-single digit percentage rate at constant exchange rates.
Novartis AG, Q2 2015 Earnings Call, Jul 21, 2015
Jul 14 15
Novartis AG, Q2 2015 Earnings Call, Jul 21, 2015
Novartis Announces That the US Food and Drug Administration Approves Entresto Tablets
Jul 7 15
Novartis announced that the US Food and Drug Administration (FDA) has approved Entresto(TM) (sacubitril/valsartan) tablets, previously known as LCZ696, for the treatment of heart failure with reduced ejection fraction. Entresto will be available on prescription for patients whose condition is classified NYHA class II-IV, indicated to reduce the risk of cardiovascular death and heart failure hospitalization. It is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other angiotensin receptor blocker. The FDA's decision is based on results from the 8,442-patient PARADIGM-HF study which was stopped early when it was shown Entresto significantly reduced the risk of cardiovascular death versus ACE-inhibitor enalapril. At the end of the study, patients with reduced ejection fraction who were given Entresto were more likely to be alive and less likely to have been hospitalized for heart failure than those given enalapril. Analysis of safety data showed that Entresto had a similar tolerability profile to enalapril. Entresto is currently undergoing review by Health Authorities around the world, including in Canada, Switzerland and the EU. Once approved by health authorities around the world, Entresto could achieve estimated peak sales in excess of $5 billion for the reduced ejection fraction indication.
Novartis Announces Publication in the Lancet Showing Sustained Efficacy with Secukinumab over One Year in Psoriatic Arthritis Patients
Jun 30 15
Novartis announced that new one year results from the pivotal Phase III FUTURE 2 study of secukinumab in psoriatic arthritis (PsA) were published in The Lancet following fast-track review. Secukinumab is the first interleukin-17A (IL-17A) inhibitor to demonstrate efficacy in a Phase III study in adult patients with active PsA. PsA is a long-term, debilitating, inflammatory disease associated with joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers, persistent painful tendonitis and irreversible joint damage. The new study results published in The Lancet show improvements observed with subcutaneous secukinumab 300 mg and 150 mg were sustained over one year of treatment in the majority of patients (64% for both doses), as measured by the American College of Rheumatology response criteria (ACR 20). Moreover, ACR 50 response rates were also sustained to one year in secukinumab 300 mg and 150 mg (44% and 39% respectively). Secukinumab met the primary endpoint of the study, which was ACR 20 at Week 24 with response rates significantly higher in the secukinumab 300 mg (54%; p<0.0001) and 150 mg (51%; p<0.0001) groups versus placebo (15%), with clinical improvements observed as early as Week 3. ACR 20 and 50 are standard tools used to assess improvement of PsA signs and symptoms, and represent a 20% and 50% improvement from baseline, respectively. Secukinumab 300 mg and 150 mg also significantly improved a key secondary endpoint which was improvement in psoriasis symptoms, as measured by 90% improvements in Psoriasis Area and Severity Index score (PASI 90). Achieving PASI 90 means that patients can attain clear to almost clear skin. This is important as the majority of people living with PsA have a history of, or concomitant, psoriasis, another long-term condition which is characterized by thick and extensive skin lesions, called plaques, known to cause itching, scaling and pain. Although the secukinumab benefits seen in FUTURE 2 were generally higher in patients without previous treatment with standard of care anti-TNF therapy, clinical benefits were observed in both anti-TNF-na?ve patients and those with an inadequate response to anti-TNFs. This is important as many patients do not respond to, or tolerate these therapies and approximately 40% of people are dissatisfied with current treatments. There is therefore, a high unmet need for patients with PsA. Secukinumab was well tolerated in FUTURE 2, with a safety profile consistent with that observed in the psoriasis clinical trial program involving nearly 5,000 patients. The most common adverse events (AEs) were upper respiratory tract infections and the common cold.
US Seeks Up to USD 3.35 Billion in Novartis AG Kickback Lawsuit
Jun 30 15
The United States says Novartis AG should pay as much as USD 3.35 billion in damages and civil fines because the drugmaker used kickbacks to boost sales of two drugs covered by Medicare and Medicaid. In papers filed in Manhattan federal court, the government said it deserves that sum under the federal False Claims Act over alleged improper reimbursements for Exjade, used by patients who receive blood transfusions, and Myfortic, for patients with kidney transplants. The government is seeking up to USD 1.52 billion in damages, representing triple the sums allegedly reimbursed and tainted by kickbacks between 2004 and 2013. It also wants as much as USD 1.83 billion in fines, equal to USD 5,500 to USD 11,000 for each of the 166,031 allegedly false claims submitted for reimbursement. Novartis continues to dispute the allegations and is continuing to defend itself in this litigation. A jury trial is scheduled to begin on November 2 and could last several weeks, court papers show. The government often settles False Claims Act cases before trial. Novartis is being sued by the federal government, 11 intervening U.S. states, and David Kester, a whistleblower and former Novartis respiratory account manager acting on behalf of 17 other states. The lawsuit accuses Novartis of paying kickbacks, in the form of rebates, to three specialty pharmacies to induce them to recommend refills of Exjade, which is intended to reduce iron levels in patients. It also accuses the drugmaker of offering similar rebates to five other pharmacies to induce them to recommend Myfortic, an immunosuppressant, over rival drugs including Roche Holding AG's CellCept and generic equivalents. The intervening states also alleged state law claims with respect to Exjade.