Earnings Release • Oct 28, 2014
Preview not available for this file type.
Download Source FileCopenhagen, 2014-10-28 08:03 CET (GLOBE NEWSWIRE) --
-- Lyxumia® 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, 28 October 2014 – Zealand Pharma A/S (“Zealand”) (Nasdaq
Copenhagen: ZEAL) today reports Lyxumia® 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® 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® 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® 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®, David
Solomon, President and CEO of Zealand, said:
“We are very pleased to witness the increasing market uptake of Lyxumia®, a
once-daily prandial GLP-1 agonist with a beneficial effect on weight. Lyxumia®
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® royalty revenue in Q4. However, no
guidance is given on full year royalty revenue, since Sanofi gives no guidance
on Lyxumia® 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®) 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® and to fixed low double-digit percentage royalties on global
full net sales of LixiLan, the single once-daily injection combination of
Lyxumia® with Lantus®, 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 Officer
Tel: +45 2220 6300
Hanne Leth Hillman, Vice President and Head of IR & Corporate Communications
Tel: +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® and in Phase III development as a single-injection combination with
Lantus® (LixiLan), both under a global license agreement with Sanofi. US
regulatory filing for both products is planned for 2015 ? summer for Lyxumia®
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
Building tools?
Free accounts include 100 API calls/year for testing.
Have a question? We'll get back to you promptly.