Zealand Pharma A/S announces Full Year results and Annual Report for 2011
3/15/2012 3:30 AM EST
Zealand Pharma A/S
Company Announcement
Zealand Pharma A/S announces Full Year results and Annual Report for 2011
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:
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.