In the first-quarter earnings investor presentation, Novo Nordisk (NVO) has guided for YoY revenue growth of 2% to 5% at CER (constant exchange rate) in fiscal 2019. The company expects its reported revenue to benefit by three percentage points due to favorable foreign exchange fluctuations in fiscal 2019. In the first quarter, the company reported revenues of $4.46 billion, a YoY rise of 0.32%, attributable to the robust demand for the company’s diabetes and obesity products coupled with stable uptake of its biopharma products.
Analysts expect Novo Nordisk’s revenues to rise YoY by 3.14% to $18.26 billion in fiscal 2019, and 5.76% to $19.31 billion in fiscal 2020. Analysts also expect the company’s revenues to change YoY by 1.95% to $4.47 billion in the second quarter, 7.67% to $4.66 billion in the third quarter, and 4.59% to $4.76 billion in the fourth quarter of fiscal 2019. While these forecasts are in dollar terms, Novo Nordisk’s presentation currency is Danish kroner.
Upcoming R&D milestones
On March 20, Novo Nordisk filed an application using a PRV (priority review voucher) and seeking approval for oral semaglutide for glycaemic control in type 2 diabetes patients. Based on standard FDA review timelines, a PRV is expected to reduce the review time for this new drug application to six months. Accordingly, the FDA’s decision is expected by the end of the third quarter.
On April 26, Novo Nordisk filed an application to the European Medicines Agency for oral semaglutide in glycaemic control indication. The company has also filed an application for oral semaglutide in this indication in Canada.
According to the first-quarter earnings call, Novo Nordisk has filed an NDA and an sNDA (supplemental new drug application) seeking approval for oral semaglutide and Ozempic, respectively, in the cardiovascular risk reduction indication. Based on the standard FDA review timeline of ten months from the date of submission, the company expects a regulatory decision for these applications in the first quarter of fiscal 2020.