Copenhagen, 2012-03-15 08:30 CET (GLOBE NEWSWIRE) -- Company Announcement No. 7/2012 ? Revenue and other operating income up 94% to DKK 171 (EUR 23) million ? Positive net result of DKK 13 (EUR 2) million ? Cash and securities of DKK 428 (EUR 57) million end 2011 ? Substantial pipeline advances, including regulatory filing by Sanofi for approval of lixisenatide (Lyxumia®1)) in Europe, the first Zealand Pharma invented drug to reach registration phase ? Strengthened position in the diabetes/metabolic field with the signature of a global collaboration agreement with Boehringer Ingelheim ? Financial outlook for 2012: Revenue from milestone payments already received in 2012 of DKK 120 (EUR 16) million with related royalty expenses of DKK 15 (EUR 2) million. No further guidance on milestone based revenue provided Operating expenses of DKK 180-200 (EUR 24-27) million, of which DKK 30 (EUR 4) million is expected to be partner funded Copenhagen, 15 March 2012 – Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL), a Danish biotechnology company dedicated to the innovation and development of peptide drugs, reports substantial growth in revenue and other operational income, a positive net result, cash preservation and important progress in its drug pipeline and business activities for the twelve month period from 1 January to 31 December 2011. 2011 Financial highlights -- Revenue of DKK 142.3 (EUR 19.1) million (2010: DKK 87.4 (EUR 11.7) million), stemming mainly from payments under the agreement with Boehringer Ingelheim. -- Total operating expenses of DKK 161.8 (EUR 21.7) million (2010: DKK 185.6 (EUR 24.9) million). -- Other operating income of DKK 28.4 (EUR 3.8) million (2010: DKK 0.8 (EUR 0.1) million). -- Net profit of DKK 13.4 (EUR 1.8) million (2010: Net loss of DKK 104.6 (EUR 14.0) million). -- Cash and securities amounted to DKK 427.7 (EUR 57.4) million on 31 December 2011 (2010: DKK 433.0 (EUR 58.1) million). -- Revenues, operating income and operating expenses are all in line with the financial guidance provided for 2011 2011 Business highlights -- Consecutively positive top-line results announced in 2011 from several studies under the global Phase III GetGoal program evaluating lixisenatide (Lyxumia®) as a novel treatment for Type 2 diabetes. The results demonstrate the efficacy and safety of lixisenatide in achieving improved glycemic control in adult patients with Type 2 diabetes; as an add-on to existing anti-diabetic treatments, including in combination with basal insulin. -- In June 2011, a global license and collaboration agreement was signed with Boehringer Ingelheim to advance novel dual acting glucagon/GLP-1 agonists, including ZP2929, to treat patients with Type 2 diabetes and obesity. Obese Type 2 diabetes patients constitute one of the fastest growing segments of the diabetes market. Under the agreement, Zealand Pharma is eligible to milestone payments for new drugs developed under the agreement, including potentially up to EUR 376 million relating to ZP2929 alone, as well as to royalties on potential future sales. Boehringer Ingelheim funds all activities under the collaboration. -- During 2011, Zealand Pharma regained full rights to danegaptide, an internally invented small peptide agonist, and identified additional development options for this drug candidate in the field of cardiac protection. Highlights in Q4 2011 -- Sanofi filed before the European Medicines Agency (EMA) a Marketing Authorization Application (MAA) for lixisenatide (Lyxumia®) for the treatment of Type 2 diabetes. Filing with the US Food & Drug Administration (FDA) is expected in Q4 2012. -- A new Clinical and Scientific Advisory Board consisting of internationally renowned scientific and clinical experts was appointed to evaluate and advice on a continuous basis on Zealand Pharma’s pipeline products and projects. -- Positive top-line results reported from a Phase IIIb study, GetGoal Duo 1, showing the efficacy and safety of lixisenatide to achieve improved glycemic control in combination with Lantus®. -- Positive top-line results reported from the GetGoal-M Phase III study, showing that lixisenatide as add-on to metformin, significantly improves glycemic control and is well tolerated in Type 2 diabetes patients inadequately controlled on metformin. -- Milestone payments of DKK 22.3 (EUR 3) million received from Helsinn Healthcare relating to the development of elsiglutide, a novel Zealand Pharma invented GLP-2 agonist, for the prevention of diarrhea in cancer patients receiving chemotherapy. -- Net result of DKK -19.2 (EUR 2.6) million for Q4 2011 in line with expectations. Highlights after the balance sheet date -- Positive top-line results reported from the GetGoal-P Phase III study, showing that lixisenatide significantly reduces blood glucose levels (HbA1c) in patients with Type 2 diabetes. -- Receipt of a milestone payment of DKK 112.5 (USD 20) million from Sanofi following completion of the global GetGoal clinical program for lixisenatide. -- Start of dosing in a Phase IIa study of elsiglutide, conducted by Helsinn, in patients with colon cancer treated with 5-fluorouracil, and Zealand Pharma has received an additional milestone payment of DKK 7.4 (EUR 1) million related to the continuously positive development of elsiglutide. David H. Solomon, President and CEO of Zealand Pharma, commented on the report: “2011 was a very successful year for Zealand Pharma. Our partner Sanofi filed an MAA for lixisenatide in Europe, and we moved an important step closer to our objective of generating sustainable revenue from Zealand Pharma invented drugs on the market. Despite substantial advances in our activities, we managed to preserve our strong cash position as a consequence of our partnerships - and we feel confident about the prospects for meeting our objective of providing value to patients and our shareholders as a profitable next generation biotech company.” Financial outlook for 2012 Revenue from milestone payments already received in 2012 from Sanofi and Helsinn amounts to DKK 120 (EUR 16) with related royalty expenses of DKK 15 (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. Total operating expenses for 2012 are expected in the range of DKK 180-200 (EUR 24-27) million. Hereof, approximately DKK 30 (EUR 4) million is expected to be funded via operating income under partner agreements, corresponding to expected net operating expenses of DKK 150-170 (EUR 20-23) million. Financial calendar for 2012 25 April 2012 Interim report for the 1st quarter 2012 and Annual General Meeting 24 August 2012 Interim report for the 1st half of 2012 13 November 2012 Interim report for 9 month of 2012 The Annual Report 2011 An electronic copy of the 2011 Annual Report can be found on the Company’s website today at http://ir.zealandpharma.com/annuals.cfm. Printed versions of the Annual Report will be distributed in early April and will be available from Zealand Pharma upon request. Conference call Zealand Pharma will host a conference call today, Thursday, 15 March at 14:00 CET/ 9:00 EST. David H. Solomon, President & 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 2011 Annual Report, followed by a Q&A session. The conference call will be conducted in English and the dial-in numbers are: DK +45 3272 9273 UK and international +44 (0) 20 3003 2666 US +1 866 966 5335 A live broadcast of the conference call including a slide presentation will be screened at the following link (http://livecast.se/stockontv/120315/zealandpharma/) and participants are recommended to register approximately 15 minutes ahead of the presentation. # # # For further information, please contact: Zealand Pharma A/S David H. Solomon, President & CEO, Tel: +45 2220 6300 Hanne Leth Hillman, Vice President for IR & Corporate Communication, Tel: +45 5060 3689, email: hlh@zealandpharma.com About Zealand Pharma Zealand Pharma A/S is a public (NASDAQ OMX: ZEAL) biotechnology company based in Copenhagen, Denmark with a mature clinical pipeline of innovative peptide drugs. The company's lead invention is lixisenatide (Lyxumia® 1)), a once-daily GLP-1 agonist licensed to Sanofi for the treatment of Type 2 diabetes. In October, Sanofi submitted a marketing authorization application (MAA) for lixisenatide in Europe and submission for regulatory approval in the United States is expected in Q4 2012. Zealand Pharma also has a collaboration with Boehringer Ingelheim covering dual acting glucagon/GLP-1 agonists, including ZP2929, for the treatment of diabetes and obesity, and a license agreement with Helsinn Healthcare on elsiglutide, a clinical stage GLP-2 drug for the prevention of chemotherapy-induced diarrhea. Zealand Pharma specializes in the discovery, optimization and development of novel peptide drugs, and all drug candidates in its pipeline have been identified through the company's own drug discovery activities. Zealand Pharma's products target 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. Note 1) Lyxumia® is the intended trademark for lixisenatide. Lixisenatide is not currently approved or licensed anywhere in the world.