Copenhagen, 15 November 2013 – Zealand Pharma A/S (CVR no. 20 04 50 78) (NASDAQ OMX Copenhagen: ZEAL) (“Zealand”) today announced its un-audited interim report for the nine-month period from 1 January to 30 September 2013.
Financial highlights for the first nine months of 2013
(Comparative figures for the same period 2012 are shown in brackets)
• Revenue of DKK 3/EUR 0.5 million (DKK 224/EUR 30 million).
• Net operating expenses of DKK 143/EUR 19 million (DKK 120/EUR 16 million).
• Net result of DKK -139/EUR -19 million (DKK 89/EUR 12 million).
• Earnings per share of DKK -6.1/EUR -0.8 (DKK 3.9/EUR 0.5).
• End of period cash and securities of DKK 358/EUR 48 million (DKK 498/EUR 69 million).
Product and pipeline highlights for the third quarter of 2013 and the period thereafter
Lyxumia® (lixisenatide) - Type 2 diabetes (licensed to Sanofi)
• Sanofi is continuing the progressive commercial roll-out of Lyxumia® globally, including in Japan where the product was launched in October and provides adult Japanese diabetes patients with the first GLP-1 receptor agonist that is approved for use in combination with basal insulin.
• Lyxumia® is now approved in Europe, Japan, Mexico, Australia, Brazil, Colombia, Chile and Euquador and under regulatory review in a number of other countries.
• At the 49th Annual Meeting of EASD in September, a sub-analysis of results from the pivotal GetGoal-L study was presented showing that Lyxumia®, when added to basal insulin, lowered blood sugar (HbA1c) especially when fasting glucose was controlled. These data support the known complementary effects of Lyxumia® as a prandial GLP-1 receptor agonist in combination with basal insulin.
• In September, Sanofi withdrew the New Drug Application (NDA) for lixisenatide in the U.S which included early interim results from the ongoing ELIXA cardiovascular outcome study. The decision was a consequence of discussions with the FDA regarding its proposed process for the review of interim results. Sanofi believes that potential public disclosure of early interim data, even with safeguards, could compromise the integrity of the ongoing ELIXA study. The withdrawal of the NDA was thus not related to safety issues or deficiencies in the NDA and Sanofi will resubmit the NDA for lixisenatide in 2015, after completion on the ELIXA study.
Lantus®/Lyxumia® combination product – Type 2 diabetes (licensed to Sanofi)
• The combination of Lyxumia® and Lantus® (basal insulin), the investigational LixiLan fixed-ratio product, remains on schedule to enter into Phase III in the first half of 2014. The withdrawal of the US NDA for Lyxumia® has not affected these plans.
Danegaptide - Ischemic reperfusion injury
• Zealand has completed preparations for a Phase II Clinical Proof-of-Concept study of danegaptide to evaluate the efficacy and safety of this novel peptide drug as a protective treatment against reperfusion injuries. Dosing of the first patients with a myocardial infarction (heart attack) undergoing percutaneous coronary intervention treatment is expected soon.
• Danegaptide is a Zealand-invented peptide which has the potential to be the first medicinal therapy to protect against tissue damage following reperfusion.
ZP2929 - Type 2 diabetes and/or obesity (partnered with Boehringer Ingelheim)
• Zealand and Boehringer Ingelheim continue to work closely together on the clinical Phase I development of ZP2929, a novel therapeutic approach in diabetes and/or obesity. Current activities include extended preclinical studies to fulfill FDA requirements for additional elucidation of the drug candidate’s therapeutic profile.
• Zealand expects to be able to give a further update on the timelines for the ZP2929 Phase I program in the first quarter of 2014.
Elsiglutide - Chemotherapy induced diarrhea (partnered with Helsinn)
• Helsinn continues preparation for the advancement of elsiglutide into a Phase IIb clinical dose finding study to further evaluate the potential of this promising peptide drug in the prevention of chemotherapy induced diarrhea in colorectal cancer patients.
• The start of Phase IIb is expected in 2014.
ZP3022 – a GLP-1-gastrin dual acting receptor agonist
• At EASD in September, Zealand presented new preclinical data on ZP3022, which support the disease modifying potential of this novel dual-acting peptide. The data demonstrate the ability of ZP3022 to significantly increase beta cell proliferation, reduce beta cell death (apoptosis) and enhance glucose-stimulated insulin secretion in preclinical in-vitro models of Type 2 diabetes.
• Zealand continues to explore the properties of GLP-1-gastrin dual acting receptor agonists as a novel approach for the treatment and potential prevention of disease progression in Type 2 diabetes patients.
New collaboration agreement with Lilly in Type 2 diabetes and obesity
• In August, Zealand signed a collaboration agreement with Lilly to jointly design and develop potentially novel peptide drugs against a novel target relevant for the treatment of Type 2 diabetes and obesity.
• Zealand and Lilly will share funding, risk and reward in this potentially multi-target collaboration which may also be expanded into other disease areas.
Other highlights for the third quarter of 2013 and the period thereafter
Appointment of new Chief Scientific Officer
• In October, Dr Torsten Hoffmann joined Zealand as Chief Scientific Officer from a senior role at Roche where he was Head of Medicinal Chemistry. Torsten Hoffmann brings with him almost two decades of experience from the pharmaceutical industry and a broad scientific track record. At Zealand, he is now responsible for the company’s research and development activities and his focus is on enhancing peptide innovation and strengthening the pipeline of peptide drug candidates as a base for continuous value building, including partnering activities.
In a comment to this interim report, David Solomon, President and CEO of Zealand, said: “In this past period, we have met important operational and strategic goals for Zealand, while beginning slowly to also benefit financially from Sanofi’s sales of Lyxumia®. Sanofi is continuing the commercial roll-out of the product as a new medicinal option for diabetes patients and has confirmed that preparations to start Phase III development of the Lyxumia®/Lantus® combination product in the first half of 2014 are underway.
“In our efforts to advance and grow our proprietary pipeline of unique peptide candidates, we also look forward to soon start dosing of patients in a Phase II study of danegaptide, which represents a promising new treatment for the potential prevention of reperfusion injuries. In support of our longer-term value growth, we have entered into a new partnership collaboration with Lilly, a further validation of Zealand’s competences in peptide drug design and development.
“We were also delighted to welcome Torsten Hoffmann as our new Chief Scientific Officer. Torsten will be instrumental in further leveraging the strong momentum in our R&D organization going forward. With his broad experience and dedicated focus on innovative peptide discovery and development we will continue to grow our pipeline, targeting our next breakthrough peptide therapies.”
Financial outlook for 2013 revised:
Net operating expenses lowered – revenue expectations unchanged
Zealand retains expectation of further revenue from Lyxumia® sales royalties in 2013 beyond what has been reported for the first nine months’ period. As Sanofi has given no guidance on expected sales of Lyxumia®, no more specific revenue guidance can be provided at this point in time.
Expectations for net operating expenses in 2013 have been revised to a range of DKK 195-205 (EUR 26-28) million from DKK 210-240 (EUR 28-32) million.
Conference call
Zealand will host a conference call today, at 2 pm CET/ 8 am EST to present the interim report for the first nine months 2013, which will be followed by a Q&A session. The call will be hosted by David Solomon, President and CEO, Mats Blom, CFO and Hanne Leth Hillman, Vice President for Investor Relations and Corporate Communications.
The call will be conducted in English and the dial-in details to access the call are as follows:
DK: +45 32 72 80 18
US: (FreeCall dial-in) +1 866 682 8490
UK and international: +44 (0) 1452 555131
Conference ID-number: 9974 6033
A live audio cast of the call including an accompanying slide presentation will be available via the following link: http://storm.zoomvisionmamato.com/player/zealand_pharma/objects/8avr91f6/
The audiocast can also be accessed from the investor section of Zealand’s website (www.zealandpharma.com) and participants are advised to register approximately 10 minutes before the call starts. An on-demand version of the audiocast will also be available on the website following the call.
For further information, please contact:
David Solomon, President and Chief Executive Officer
Tel: +45 22 20 63 00
Hanne Leth Hillman, Vice President, Investor Relations & Corporate Communications Tel: +45 50 60 36 89, email: hlh@zealandpharma.com
About Zealand Pharma
Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL) (“Zealand”) is a biotechnology company based in Copenhagen, Denmark. Zealand 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 cardio-metabolic diseases, diabetes and obesity in particular, and its lead drug invention is lixisenatide, a once-daily prandial GLP-1 agonist, which is licensed to Sanofi for the treatment of Type 2 diabetes. Lixisenatide (marketed by Sanofi as Lyxumia®) is approved in several countries, including Europe and Japan, and under regulatory review in a number of other countries globally. In the U.S., an NDA is planned to be submitted in 2015, after completion of the ELIXA CV outcome study.
Zealand has a partnering strategy for the development and commercialization of its products and in addition to the license agreement with Sanofi in Type 2 diabetes, the company has partnerships with Boehringer Ingelheim in diabetes/obesity, Lilly in diabetes and obesity, Helsinn Healthcare in chemotherapy induced diarrhea and AbbVie in acute kidney injury.
For further information: www.zealandpharma.com. @ZealandPharma
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