10 February 2011 -- For the full year 2010 Zealand Pharma generated revenue of DKK 87.4 (EUR 11.7) million, compared to DKK 25.3 (EUR 3.4) million in 2009, and recorded a loss before tax of DKK 104.6 (EUR 14.0) million. The revenue stems primarily from milestone payments from sanofi-aventis relating to lixisenatide.
The loss before tax is lower than the previous outlook of DKK 110-120 (EUR 15-16) million mainly as a result of lower costs for incentive programs. As of 31 December 2010 the company’s cash and cash equivalents plus liquid investments in securities amounted to DKK 433.0 (EUR 58.1) million.
In November 2010 Zealand Pharma completed an Initial Public Offering and listed on the NASDAQ OMX in Copenhagen raising DKK 372.9 (EUR 50.0) million (gross).
During the year, Zealand Pharma’s R&D pipeline in the field of peptide drugs made good progress, notably with the lead drug candidate, lixisenatide, but also with Zealand Pharma’s other portfolio programs.
Highlights from 2010
Pipeline achievements
• Zealand Pharma’s partner sanofi-aventis announced positive Phase III top-line results from the first two GetGoal clinical trials with lixisenatide;
o All study endpoints were successfully met in the two trials and lixisenatide was generally well tolerated with no significant adverse events
o As monotherapy, lixisenatide significantly reduced blood sugar levels vs. placebo
o In combination with basal insulin, lixisenatide showed significant improvement in glucose control in patients with type 2 diabetes
• Zealand Pharma received milestone payments from its partner sanofi-aventis relating to lixisenatide of a total of DKK 82.8 (USD 15.0) million.
• The global licensing agreement with sanofi-aventis was amended to provide for the development and commercialization of lixisenatide in combination with Lantus®, sanofi-aventis’ recombinant human long-acting insulin analog.
• Sanofi-aventis announced publically their expected initiation of the lixisenatide + Lantus® combination product Phase III within 12-18 months from September 2010.
• Zealand Pharma achieved positive results from a Phase Ib trial of ZP1848 for the treatment of Crohn’s disease. Business events
• In November Zealand Pharma raised gross DKK 372.9 (EUR 50) million in an Initial Public Offering making it the largest European biotech IPO in 2010. The company issued 4,336,047 new shares and is now listed at the NASDAQ OMX Copenhagen under the ticker symbol ZEAL.
• In March the management team was strengthened with the appointment of three new members. Christian Grøndahl joined as Chief Scientific Officer, Mats Blom joined as Chief Financial Officer and John Hyttel, co-founder of Zealand Pharma, was appointed Senior Vice President for Operations.
Events after the balance sheet date
• In February 2011, Zealand Pharma’s partner sanofi-aventis announced positive data from the GetGoal-X Phase III study of lixisenatide. Lixisenatide achieved its primary endpoint of non-inferiority in HbA1c reduction from baseline, compared with exenatide twice-daily.
Outlook 2011
In 2011, Zealand Pharma expects total operating expenses of approximately DKK 170 (EUR 22.8) million.
Most of Zealand Pharma’s revenue stems from activity triggered milestone payments from its partners. As the timing of such payments is largely outside the control of Zealand Pharma, the company does not provide guidance on future revenue.
David Solomon, President and CEO commented on the report:
“2010 was a transformational year for Zealand Pharma. We achieved an IPO in November and joined NASDAQ OMX Copenhagen having raised DKK 372.9 million (gross). We’re delighted that our lead compound, lixisenatide, showed positive top-line results - three Phase III studies in the GETGOAL clinical trial program have now been announced and all met primary endpoints and confirmed the attractive efficacy and safety profile of lixisenatide. We also look forward to continuing our close cooperation with Helsinn Healthcare on the further development of ZP1846, a novel therapy for the treatment of chemotherapy-induced diarrhoea. We would like to thank all staff for their dedication to Zealand Pharma and our existing and new shareholders for their continued support. We look forward to further pipeline developments and clinical data throughout 2011 and to an exciting future ahead as a listed company.”
Conference call
The company will host a conference call today, Thursday, February 10 at 15:00 CET. David Solomon, President & CEO, and Mats Blom, CFO, will present the year-end results followed by a Q&A session. The conference call will be conducted in English and the dial-in numbers are:
DK +45 32 71 46 07 UK and international +44 (0) 145 255 5566 US +1 866 966 9439 Passcode for all participants: 42824017
An accompanying presentation will be available for download from the company’s website (ir.zealandpharma.com) approximately one hour before the event.
For further information, please contact:
Zealand Pharma A/S David Solomon, President and Chief Executive Officer Tel: +45 4328 1200 M:Communications Mary-Jane Elliott / Emma Thompson / Amber Bielecka / Ulf Martensson Tel: +44 20 7920 2330 / +46 8 407 22 43
