Zealand reports Lyxumia(r) royalty revenue for the first 9 months of 2014
Lyxumia(R) royalty revenue to Zealand was DKK 14.1 (EUR 1.9) million for the first 9 months of 2014
Continuously high growth quarter-on-quarter with Q3 2014 royalty revenue up 38% from Q2 2014 to DKK 6.0 (EUR 0.8) million
COPENHAGEN, Denmark, Oct. 28, 2014 (GLOBE NEWSWIRE) -- Zealand Pharma
A/S ("Zealand") (Nasdaq Copenhagen: ZEAL) today reports Lyxumia(R)
royalty revenues of DKK 14.1 (EUR 1.9) million for the first 9 months
of 2014, based on Sanofi's global ex-US sales of the product for the
period. Lyxumia(R) was launched in the first markets by end March 2013.
In Q3 2014, royalty revenue was DKK 6.0 (EUR 0.8) million with 50%
generated from sales in Western Europe, 25% from sales in Emerging
Markets and 25% from sales in the Rest of the World, including Japan.
The main contributing countries were the UK, Spain, Japan and Brazil.
Royalty revenue generated in Q3 2014 was up 38% compared to Q2 2014.
Sanofi has launched Lyxumia(R) in over 20 countries and received
approval for the product in over 50 countries with several launches
planned in Q4 and 2015.
Sanofi plans to resubmit a regulatory filing for Lyxumia(R) in the US
in Summer 2015 following the completion of the ELIXA cardio-vascular
safety study, from which Sanofi expects to present top-line results in
Q2 2015.
In a comment to this royalty revenue report and the status of
Lyxumia(R), David Solomon, President and CEO of Zealand, said:
"We are very pleased to witness the increasing market uptake of
Lyxumia(R), a once-daily prandial GLP-1 agonist with a beneficial
effect on weight. Lyxumia(R) is the first peptide therapeutic from
Zealand's pipeline to be launched, and we believe that the product has
great potential to become an important diabetes medicine as marketed by
Sanofi. We look forward to following Sanofi's continued roll-out and to
the highly important clinical results of ELIXA, leading to the planned
refiling of the product in the US in the Summer of 2015."
Financial outlook for 2014 and terms of the license collaboration with
Sanofi
Zealand's financial outlook for 2014 remains unchanged, including
revenue from milestone payments of DKK 133 (EUR 18) million.
In addition to the DKK 14.1 (EUR 1.9) million for the first 9 months of
the year, Zealand will receive further Lyxumia(R) royalty revenue in
Q4. However, no guidance is given on full year royalty revenue, since
Sanofi gives no guidance on Lyxumia(R) sales.
Zealand's net operating expenses in 2014 are expected at a range of DKK
195-205 (EUR 25-28) million.
Under the license agreement with Sanofi, covering lixisenatide
(Lyxumia(R)) and any combination products which include lixisenatide,
Zealand is eligible to receive remaining milestone payments of up to
USD 160 million. Further, Zealand is entitled to tiered low
double-digit percentage royalties on Sanofi's global sales of
Lyxumia(R) and to fixed low double-digit percentage royalties on global
full net sales of LixiLan, the single once-daily injection combination
of Lyxumia(R) with Lantus(R), currently in Phase III clinical
development and with regulatory filing expected as early as end 2015.
***
For further information, please contact:
David H. Solomon, President and Chief Executive OfficerTel: +45 2220
6300
Hanne Leth Hillman, Vice President and Head of IR & Corporate
CommunicationsTel: +45 5060 3689, email: [email protected]
About Zealand Pharma
Zealand Pharma A/S ("Zealand") (Nasdaq Copenhagen: ZEAL) is a
biotechnology company based in Copenhagen, Denmark. Zealand has leading
expertise in the discovery, design and development of novel peptide
medicines, in-house competences in clinical trial design and management
and a therapeutic focus on cardio-metabolic diseases. The company has a
broad portfolio of therapeutic products - proprietary and partnered.
Zealand's first invented medicine, lixisenatide, a once-daily prandial
GLP-1 agonist for the treatment of Type 2 diabetes, is marketed
world-wide ex-US as Lyxumia(R) and in Phase III development as a
single-injection combination with Lantus(R) (LixiLan), both under a
global license agreement with Sanofi. US regulatory filing for both
products is planned for 2015 ? summer for Lyxumia(R) and as early as
end 2015 for LixiLan.
Zealand is advancing a pipeline of proprietary, next-generation
therapies, including danegaptide (prevention of Ischemic Reperfusion
Injury) in addition to several preclinical programs. Partnering
represents an important component of strategy to share development risk
in large clinical trials, to provide funding and to commercialize the
company's products. Zealand currently has global license agreements and
partnerships with Sanofi, Boehringer Ingelheim, Helsinn Healthcare and
Lilly.
For further information: www.zealandpharma.com Follow us on
Twitter@ZealandPharma