Copenhagen, 2012-08-24 08:30 CEST (GLOBE NEWSWIRE) -- Company Announcement No. 18/2012 - Positive net results of DKK 89 (EUR 12) million for the period - Revenue from milestone payments of DKK 186 (EUR 25) million - Pipeline progress, including advances for Lyxumia® (lixisenatide) - Cash and securities of DKK 525 (EUR 71) million on 30 June 2012 - Financial guidance for 2012 raised to an expected positive net result at a range of DKK 37-57 (EUR 5-8) million Copenhagen, 24 August 2012 – Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL), a biotech company dedicated to the discovery and development of peptide drugs, reports revenue growth, a net profit and an increase in cash and securities combined with the achievement of several important pipeline milestones for the six month period 1 January to 30 June 2012. Financial Highlights in H1 2012 -- Revenue of DKK 186.2 (EUR 25.1) million consisting of milestone payments from partners, Sanofi and Helsinn Healthcare, and former partner Action Pharma (H1 2011: DKK 119.3 (EUR 16.0) million). -- Royalty expenses of DKK 15.6 (EUR 2.1) million (H1 2011: DKK 0.0 (EUR 0.0) million). -- Net operating expenses of DKK 82.8 (EUR 11.1) million (H1 2011: DKK 70.9 (EUR 9.5) million). -- Net results of DKK 89.4 (EUR 12.0) million (H1 2011: DKK 46.9 (EUR 6.3) million). -- Cash and securities as at 30 June 2012 amounted to DKK 525.0 (EUR 70.7) million (30 June 2011: DKK 445.5 (EUR 59.9) million). Pipeline Highlights in H1 2012 and the period thereafter -- Lyxumia® (lixisenatide) for Type 2 diabetes (partnership with Sanofi): - February – Positive top-line results announced from the GetGoal-P study, triggering a USD 20 (DKK 113) million milestone payment to Zealand Pharma from Sanofi for the completion of the global Phase III program, GetGoal, for lixisenatide. - June – Submission for approval of lixisenatide in Japan. - June – Data from the GetGoal Duo 1 and GetGoal-L studies presented at the American Diabetes Association’s 72th Annual Scientific Sessions (ADA), supporting the efficacy and safety of lixisenatide on top of basal insulin. A total of 17 presentations on lixisenatide were made at ADA. -- ZP2929 for Type 2 diabetes and/or obesity (partnership with Boehringer Ingelheim): - Zealand Pharma has opened an IND on ZP2929 with the FDA. - First Phase I study planned for initiation before the end of Q3 2012. -- Elsiglutide for the prevention of chemotherapy-induced diarrhea (partnership with Helsinn Healthcare): - February – Helsinn Healthcare initiated a Phase IIa study in patients with colorectal cancer, treated with chemotherapy. -- ZP1480 (ABT-719 (formerly AP214)) for the prevention of acute kidney injury (partnership with Abbott): - May – New license agreement signed with Abbott and USD 11 (DKK 66) million in milestone payment from former partner, Action Pharma. -- GLP-1-gastrin dual agonist program: - June – New preclinical data presented at ADA on ZP3022, a novel peptide agonist from Zealand Pharma’s GLP-1-gastrin dual agonist program, showing a significant improvement in glycemic control and an increase in pancreatic beta-cell mass. David Solomon, CEO and President of Zealand Pharma, commented on the report: “We are very pleased with the advances achieved across our pipeline in the first half of 2012 and to report that we continue building upon Zealand Pharma’s strong financial position. Our lead invention, Lyxumia® (lixisenatide) for Type 2 diabetes, completed the global Phase III program, GetGoal, and in addition to the filing in Europe, was submitted for approval in Japan by our partner, Sanofi. Other important milestones for our pipeline in the reported period include the agreement with Abbott on ZP1480 for the prevention of acute kidney injury and the completion of clinical preparations with ZP2929 for the treatment of Type 2 diabetes and/or obesity. “For the rest of 2012, we look forward to the expected start of clinical studies with ZP2929 before end of Q3, to a response on lixisenatide from the European regulatory authorities in Q4 and to an expected NDA filing in the US in December.” Financial guidance raised for 2012 In addition to revenues from milestone payments of DKK 186 (EUR 25) million received in H1 2012, Zealand Pharma expects other payments under an existing partnership agreement. The company therefore raises its revenue guidance for 2012 to DKK 223 (EUR 30) million from previously announced DKK 182 (EUR 24) and with related royalty expenses of DKK 16 (EUR 2) million. The timing of other potential milestone based payments from partners is largely outside the control of Zealand Pharma, and therefore no further revenue guidance is provided for the full year at this point. Guidance on net operating expenses remains unchanged at a range of DKK 150-170 (EUR 20-23) million, and as a result of the raised revenue guidance Zealand Pharma now expects a positive net result for 2012 at a range of DKK 37-57 (EUR 5-8) million. # # # Conference call Zealand Pharma will host a conference call today, at 14:00 CET/ 8:00 EST. David Solomon, President and Chief Executive Officer, Mats Blom, Chief Financial Officer and Hanne Leth Hillman, Vice President for IR and Corporate Communication, will host the call to present the Interim report for H1 2012 which will be followed by a Q&A session. The conference call will be conducted in English and the dial-in numbers are as follows: DK: +45 3272 9273 UK and international: +44 (0) 20 3003 2666 US: +1 212 999 6659 Pass code for all participants: Zealand Pharma A live audio cast of the call including an accompanying slide presentation will be available via the following link: http://livecast.wehay.com/stockontv/120824/zealandpharma/, which can also be accessed from the investor section of the company’s website (www.zealandpharma.com). Participants are advised to register for the audio cast approximately 10 minutes before the start. A replay of the event will also be available on the company’s website following the call. 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 Communication Tel: +45 5060 3689, email: hlh@zealandpharma.com About Zealand Pharma Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL) is a biotechnology company based in Copenhagen, Denmark. Zealand Pharma specializes in the discovery, optimization and development of novel peptide drugs and has a broad and mature pipeline of drug candidates identified through its own drug discovery activities. The company’s focus lies in the field of diabetes/metabolic diseases, and its lead drug invention is lixisenatide (Lyxumia®)1, a once-daily GLP-1 agonist, which is licensed to Sanofi for the treatment of Type 2 diabetes. In November 2011, Sanofi filed for registration of lixisenatide in Europe and regulatory filing in the United States is expected in Q4 2012. Zealand Pharma has a partnering strategy for the development and commercialization of its products and in addition to the collaboration with Sanofi in Type 2 diabetes, the company has partnerships with Boehringer Ingelheim in diabetes/obesity, Abbott in acute kidney injury and Helsinn Healthcare in chemotherapy induced diarrhea. Zealand Pharma focuses its activities in disease areas where existing treatments fail to adequately serve patient needs and where the market potential for improved treatments through the use of peptide drugs is high. For further information: www.zealandpharma.com. 1 Lyxumia is the proprietary name submitted to the EMA for lixisenatide. The proprietary name for lixisenatide in the United States is under consideration. Lixisenatide is not currently approved or licensed anywhere in the world.