Earnings Release • Nov 17, 2011
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Download Source FileCopenhagen, 2011-11-17 12:56 CET (GLOBE NEWSWIRE) -- Company Announcement
No. 18/2011
Zealand Pharma A/S
Interim report for the nine months ending 30 September 2011 (unaudited)
-- Positive net result of DKK 32.5 (EUR 4.4) million with cash and securities
amounting to DKK 441.9 (EUR 59.3) million on 30 September 2011
-- Guidance for revenues and other operating income in 2011 raised to DKK 170
(EUR 22.8) million from DKK 150 (EUR 20) million, expense guidance unchanged at
DKK 170 (EUR 22.8) million
-- After the period, Sanofi submitted a Marketing Authorisation Application
(MAA) for Lyxumia® 1) (lixisenatide) in Europe; first Zealand Pharma drug now in
registration phase
Copenhagen, 17 November 2011 - Zealand Pharma (NASDAQ OMX: ZEAL), a
biopharmaceutical company based in Denmark, reports important progress in its
drug pipeline and business activities and positive financial results for the
nine month period 1 January - 30 September 2011.
First nine months of 2011,
-- Revenues of DKK 120.0 (EUR 16.1) million (9m 2010: DKK 83.6 (EUR 11.2)
million) from payments under the agreement with Boehringer Ingelheim.
-- Total operating expenses amounted to DKK 114.4 (EUR 15.4) million (9m 2010:
DKK 129.4 (EUR 17.4) million), in line with expectations.
-- Other operating income for the period was DKK 23.6 (EUR 3.2) million (9m
2010: DKK 0.2 (EUR 0.0) million).
-- Net profit totaled DKK 32.5 (EUR 4.4) million (9m 2010: DKK -42.0 (EUR
-5.6) million).
-- Cash and securities amounted to DKK 441.9 (EUR 59.3) million on 30
September 2011 (30 Sept 2010: DKK 134.0 (EUR 18.0) million).
-- Important pipeline advance with additional positive Phase III results
announced for Lyxumia® (lixisenatide), now in registration phase as a novel
treatment of Type 2 diabetes.
-- A license and collaboration agreement signed with Boehringer Ingelheim to
advance novel dual acting glucagon/GLP-1 agonists, including ZP2929, to
treat Type 2 diabetes and obesity.
In October 2011, Sanofi submitted before the European Medicines Agency (EMA) a
Marketing Authorisation Application (MAA) for Lyxumia® (lixisenatide) as a
novel treatment for Type 2 diabetes. This is a significant milestone for
Zealand Pharma, as the first of the company's peptide drugs is now in the final
phase of development before market launch.
1) Lyxumia® is the intended trademark of lixisenatide
The MAA includes documentation from the extensive, international Phase III
GetGoal-program, which has provided clinical results to support the intended
use of Lyxumia® (lixisenatide) as a novel treatment for Type 2 diabetes.
Results from the GetGoal-programme demonstrate the efficacy and safety of
Lyxumia® (lixisenatide) in achieving improved glycemic control in patients with
Type 2 diabetes both as monotherapy and as an add-on to existing treatments,
including in combination with basal insulin.
Further results from the GetGoal Phase III program are expected to be presented
at international conferences during late 2011 and 2012. Additional ongoing
studies are expected to complete and report in the same period to further
elucidate the clinical profile of Lyxumia® (lixisenatide).
A regulatory submission for lixisenatide in the United States is planned for Q4
2012.
Under the agreement between Zealand Pharma and Boehringer Ingelheim, signed in
June 2011, preparations for start of clinical development of ZP2929 for the
treatment of diabetes and obesity are progressing well.
David H. Solomon, President and CEO of Zealand Pharma, commented on the report:
“The European submission of lixisenatide, our first peptide drug, represents a
transformational milestone for Zealand Pharma. Lixisenatide has potential as a
monotherapy and as an add-on to existing treatments, including in combination
with basal insulin. Supported by Sanofi's strong position in the diabetes
market and deep understanding of diabetes patients' need, we are confident that
the drug will quickly find an important role in the management of Type 2
diabetes."
Financial guidance for 2011 raised
Zealand Pharma raises its financial guidance for the full year 2011, now
expecting revenues and other operating income under the company's partnership
agreements of DKK 170 (EUR 22.8) million against earlier expectations of DKK
150 (EUR 20) million, while maintaining expectations for total operating
expenses of approximately DKK 170 (EUR 22.8) million.
- # -
Conference call
Zealand Pharma will host a conference call today, Thursday, 17 November at
15:00 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 interim
report for the first nine months of 2011 followed by a Q&A session.
The conference call will be conducted in English and the dial-in numbers are:
DK +45 3272 7625
UK and international +44 (0) 1452 555 566
US +1 631 510 7498
Pass code for all participants: 27101023
An accompanying slide presentation will be available for download from the
company's website (ir.zealandpharma.com) prior to the call.
For further information, please contact:
David H. Solomon, President and Chief Executive Officer
Tel: +45 2220 6360
Hanne Leth Hillman, Vice President for IR & Corporate Communication
Tel: +45 5060 3689
Forward-looking statements
This announcement includes “forward-looking statements” that involve risk,
uncertainties and other factors, many of which are outside of our control that
could cause actual results to differ materially from the results discussed in
the forward-looking statements. Forward-looking statements include statements
concerning our plans, objectives, goals, future events, performance and/or
other information that is not historical information. We undertake no
obligation to publicly update or revise forward-looking statements to reflect
subsequent events or circumstances after the date made, except as required by
law.
About Zealand Pharma
Zealand Pharma A/S is a public (NASDAQ OMX: ZEAL) biopharmaceutical company
based in Copenhagen, Denmark with a mature and growing clinical pipeline of
innovative peptide based drugs. The company's lead product is Lyxumia®
(lixisenatide), a once-daily GLP-1 agonist, discovered by Zealand Pharma and
licensed to Sanofi for the treatment of Type-2 diabetes. In October 2011,
Sanofi submitted an MAA for Lyxumia® (lixisenatide) in Europe and submission
for regulatory approval of lixisenatide in the United States is planned for Q4
2012. Zealand Pharma also has a collaboration with Boehringer Ingelheim
covering glucagon/GLP-1 dual agonists, including ZP2929 for the treatment of
diabetes and obesity, and a licence agreement with Helsinn Healthcare on
elsiglutide, a clinical stage GLP-2 drug for the treatment of chemotherapy- and
radiotherapy- 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.
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