Generic Version Of Vagifem In U.S. Impacts Novo Nordisk Biopharma Sales

Reported sales were broadly unchanged at $16.9 billion (2 percent growth in local currencies).

Sales within biopharmaceuticals declined by 18 percent to $2.9 billion (16 percent in local currencies), reflecting the impact in the U.S. from the introduction of a generic version of the hormone replacement therapy product Vagifem and a rebate adjustment for growth hormone in Q1 2016. Sales within hemophilia were broadly unchanged (2 percent growth in local currencies).

Sales within International Operations increased by 2 percent in Danish kroner (5 percent in local currencies) driven by sales growth in all business regions measured in local currencies. Sales within North America Operations decreased by 2 percent in Danish kroner and were unchanged in local currencies, reflecting the non-recurring effects in biopharmaceuticals impacting growth negatively by 4 percentage points.

Operating profit increased by 1 percent reported in Danish kroner and by 5 percent in local currencies to $7.4 billion. Net profit increased by 1 percent to $5.8 billion. Diluted earnings per share increased by 3 percent to $2.33.

In December, Novo Nordisk received the U.S. Food and Drug Administration (FDA) approval of Ozempic (semaglutide) for treatment of people with type 2 diabetes and a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) recommending marketing authorization for Ozempic. Ozempic will to be launched in the U.S. next week.

Chairman of the Board of Directors Göran Ando has decided not to seek re-election at the Annual General Meeting in March 2018. The board proposes current member Helge Lund to be elected as chairman.

As of February 15, 2018, Karsten Munk Knudsen, currently senior vice president of Corporate Finance, will succeed Jesper Brandgaard as chief financial officer. Jesper Brandgaard will continue as executive vice president responsible for Biopharm and Legal Affairs.

For 2018, sales growth is expected to be 2-5 percent measured in local currencies and operating profit growth is expected to be 1-5 percent. Sales growth reported in Danish kroner is expected to be 7 percentage points lower than in local currencies, reflecting the significant depreciation of the U.S. dollar and related currencies versus the Danish krone. Likewise, reported operating profit growth is expected to be 10 percentage points lower.

At the Annual General Meeting on March 22, 2018, the board will propose a final dividend of $0.78 for 2017 per share of DKK 0.20. The expected total dividend for 2017 of $1.26 per share, of which $0.48 per share was paid as interim dividend in August 2017, corresponds to an increase of 3 percent compared to 2016. The board furthermore intends to initiate a new 12-month share repurchase program of up to $2.3 billion.

“The approval of Ozempic in the U.S. was the culmination of a year in which we achieved important product approvals and label updates,” Lars Fruergaard Jørgensen, president and CEO, said. “In 2018, we will focus on the global launch of Ozempic and pursue the full value potential of our strong product portfolio in what continues to be a competitive environment.”

(Source: Novo Nordisk A/S)