=Novartis (NVS) reported earnings on Tue 25 Oct 2016 (b/o)

Novartis AG beats by $0.06, reports revs in-line; reaffirms FY16 guidance :

• Reports Q3 (Sep) earnings of $1.23 per share, $0.06 better than the Capital IQ Consensus of $1.17; revenues fell 1.1% year/year to $12.13 bln vs the $12.2 bln Capital IQ Consensus.
  • Gilenya ($790 million, +15% cc) continued double-digit growth; Cosentyx ($301 million) on track for blockbuster status in first full year after approval; Oncology growth drivers including Tafinlar + Mekinist ($172 million, +29% cc), Promacta/Revolade ($168 million, +44% cc) and Jakavi ($149 million, +47% cc); Sandoz Biopharmaceuticals ($262 million, +41% cc) delivered strong growth
• Update on regulatory submissions and filings
  • The FDA granted Breakthrough Therapy designation to LEE011 (ribociclib) in combination with letrozole as first-line treatment for women with postmenopausal HR+/HER2- advanced or metastatic breast cancer, based on positive results of the Phase III MONALEESA-2 trial.
  • Tafinlar + Mekinist (dabrafenib + trametinib) combination therapy was filed with the EMA and Swissmedic for the treatment of patients with BRAF V600E mutation-positive non-small cell lung cancer (:NSCLC). The combination has also been submitted to the FDA for the same indication.
  • PKC412 (midostaurin) was filed with the EMA and Swissmedic for the treatment of newly diagnosed FLT3 mutation-positive acute myeloid leukemia and advanced systemic mastocytosis. A rolling submission in the US is ongoing.
• Co reaffirms guidance for FY16, continues to see core operating income broadly in line or decline low single digit; continues to see net sales broadly in line with prior year (cc), or roughly $49.41 bln vs. $48.66 bln Capital IQ Consensus Estimate.
  • The co cautioned that, "If early October exchange rates prevail for the remainder of 2016, the currencyimpact for the year would be negative 1 percentage point on sales and negative3 percentage points on core operating income."
• "We are continuing toinvest for the future, as we manage the Gleevec loss of exclusivity in 2016 and2017."