Zealand reports lixisenatide (Lyxumia®) royalty revenue for Q4 2015 and highlights three key regulatory events for the product in 2016 as confirmed by Sanofi

• Royalty revenue to Zealand from Sanofi’s sales of lixisenatide (Lyxumia^®) outside the US increased to DKK 8.1 million / EUR 1.1 million in Q4 2015, up 15% over the previous quarter and up 31% over Q4 2014
• For the full year 2015, lixisenatide (Lyxumia^®) royalty revenue amounted to DKK 28.6 million / EUR 3.8 million
• Three regulatory events are expected for lixisenatide in 2016:

1. EU submission of the fixed-ratio combination of lixisenatide and insulin glargine 100 Units/mL (LixiLan) confirmed by Sanofi for Q1
2. US regulatory decision on lixisenatide in Q3 
3. US regulatory decision on the fixed-ratio combination of lixisenatide and insulin glargine 100 Units/mL (LixiLan) in Q3 provided FDA accepts the filing  

Copenhagen, 9 February 2016 – Zealand reports that royalty revenue to the company on Sanofi’s global sales of lixisenatide (Lyxumia^®) for the treatment of Type 2 diabetes outside the US amounted to DKK 8.1 million / EUR 1.1 million for the fourth quarter period from 1 October to 31 December 2015. This corresponds to an increase of 31% over the same period in 2014. Compared to the third quarter of 2015, royalties were up 15%, which is a significant pick-up in the quarterly growth rate.

For the full year 2015, royalty revenue to Zealand thus totaled DKK 28.6 million / EUR 3.8 million, which corresponds to an increase of 41% over 2014.

In a comment to this announcement, Britt Meelby Jensen, President and CEO at Zealand, said: “It is nice to see a relatively strong pick-up in our lixisenatide royalty revenues in Q4 2015. Still, however, the revenue level reflects the fact that the product is not yet available for patients in the US, which represents more than 70% of the world market for this type of medicine. We are therefore excited about the prospects of important regulatory decisions by the US FDA on lixisenatide in Q3 this year and in particular, if the file is accepted, on the combination product of lixisenatide and Lantus^® later in the same quarter. Pending regulatory approvals, US launch of these two products are planned by Sanofi for H2 2016 and could lead to a considerable increase in Zealand’s revenue.”