Copenhagen, 2013-05-15 08:35 CEST (GLOBE NEWSWIRE) --
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Company Announcement No. 14/2013 |
─ Fully in line with expectations, net result for the quarter was DKK -57 (EUR -8) million
─ Cash and securities of DKK 441 (EUR 59) million on 31 March 2013
─ Financial outlook for 2013 retained
─ European approval and launch of Lyxumia® (Type 2 diabetes), the first Zealand invented peptide medicine to be available for patients
─ Through 2013, further European roll-out of Lyxumia® by Sanofi is expected along with regulatory decisions on the product in a range of countries globally
Copenhagen, 15 May 2013 – Zealand Pharma A/S (CVR no. 20 04 50 78) (NASDAQ OMX Copenhagen: ZEAL) (“Zealand”), a Danish biotechnology company dedicated to the discovery and development of novel peptide drugs, today announces its un-audited interim report for the first quarter of 2013.
Financial highlights for the first quarter of 2013
(Comparative figures for the same period 2012 are shown in brackets)
· Revenue of DKK 0.0/EUR 0.0 million (DKK 120.3/EUR 16.2 million).
· Net operating expenses of DKK 57.9/EUR 7.8 million (DKK 39.4/EUR 5.3 million).
· Net result of DKK -57.3/EUR -7.7 million (DKK 65.7/EUR 8.8 million).
· Earnings per share of DKK -2.53/EUR -0.34 (DKK 2.90/EUR 0.39)
· End of period cash and securities of DKK 441.3/EUR 59.2 million (DKK 525.9/EUR 70.6 million).
Pipeline highlights for the first quarter 2013 and the period thereafter
Lyxumia® (lixisenatide) ─ Type 2 diabetes (license partnership with Sanofi)
· In February, Lyxumia® (lixisenatide) was approved in Europe for the treatment of adults with Type 2 diabetes. Later in the first quarter, Sanofi commenced the launch of Lyxumia®, which is now available to patients in the UK, Germany and Scandinavia. Further roll-out in the 27 EU member countries as well as in Norway, Iceland and Liechtenstein is expected through 2013.
· In February, the FDA accepted the New Drug Application filed by Sanofi in December 2012 for lixisenatide in the US. The product is now under regulatory review in a large number of countries globally, including Japan (filed June 2012).
Lantus®/Lyxumia® combination product – Type 2 diabetes (license partnership with Sanofi)
· In February, Sanofi announced that timelines for the start of Phase III studies were being reassessed following a technical issue encountered in the development of the Fix-Flex single combination product. In parallel, the enrolment of up to 323 patients in a Phase IIb study of a Fixed-Ratio combination product was completed.
· After the end of the period, in May, Sanofi announced its decision to prioritize the Fixed-Ratio combination of Lantus®/Lyxumia® for Phase III initiation. Further development timelines will be shared at the time of the American Diabetes Association (ADA) meeting in June.
ZP2929 ─ Type 2 diabetes and/or obesity (partnered with Boehringer Ingelheim)
· ZP2929 (a dual acting glucagon/GLP-1 peptide agonist) is in Phase I development under an IND (Investigational New Drug) application with the U.S. Food and Drug Administration (FDA).
· In March, Zealand announced an adjustment of the expected payments to be received in 2013 under the agreement with Boehringer Ingelheim to EUR 4 million (EUR 14 million) as a result of a revised Phase I development plan for ZP2929.
Danegaptide ─ Cardio-protection (Ischemic reperfusion injury)
· Danegaptide is a small dipeptide invented by Zealand. Zealand retains global rights to the product.
· In March, Zealand announced the decision to advance danegaptide into a Phase IIa clinical Proof-of-Concept study to further profile this promising novel peptide drug in cardio-protection. The study will be conducted at a single clinical site and is expected to start in Q4 2013.
Elsiglutide ─ Chemotherapy induced diarrhea (license partnership with Helsinn)
· Elsiglutide (a GLP-2 peptide agonist) is in Phase II development.
· In February, Helsinn completed the enrolment of up to 138 patients in a Phase IIa study. Study outcome and Helsinn’s decision regarding next step in the development of elsiglutide are expected to be announced later in H1 2013.
ZP1480 (ABT-719) ─ Acute kidney injury (license partnership with AbbVie)
· ZP1480 is a first-in-class, melanocortin (alpha-MSH) peptide analogue, which has shown promising effect in a Phase II study for the prevention of acute kidney injury.
· In a 2013 Pipeline Outlook release from 30 January 2013, AbbVie confirmed plans to start a Phase IIb study of ZP1480 for the prevention of acute kidney injury associated with major cardiac and other surgeries in 2013.
Other events during Q1 2013
· In February, Agneta Svedberg was appointed as new Senior Vice President and Chief Operating Officer and successor to John Hyttel who retired from Executive Management. In March, Christian Grøndahl, Executive Vice President and Chief Scientific Officer left the company to pursue other interests.
Commenting on the report, David H. Solomon, President and CEO of Zealand, said: “With the first marketing approval and the first European launch of a Zealand-invented peptide medicine during the quarter, this period marks the outset for sustained revenues to our company. Our license partner, Sanofi has a very strong position in the diabetes market, and we look forward to the continued roll-out of Lyxumia® through 2013. We are also pleased to have recently announced Sanofi’s confirmed ongoing commitment to the development of the Lantus®/Lyxumia® single combination product.
“In the months ahead, we anticipate continued progress with expected regulatory decisions on Lyxumia® in a number of countries globally, further development timelines to be announced for the Lantus®/Lyxumia® combination product as well as development advances with our other clinical pipeline products.”
Financial outlook for 2013
Zealand retains its financial outlook for 2013 as announced in the Full Year announcement and Annual Report for 2012 on 14 March 2013 (Company Announcement No.8/2013). The company expects revenue from royalties on first sales of Lyxumia® and potential success based milestone payments from collaboration partners. As Sanofi has given no guidance on the expected sales of Lyxumia® and as the timing of milestone based payments is largely outside Zealand’s control, no revenue guidance is provided at this point in time.
Net operating expenses in 2013 are expected at a range of DKK 210-240 (EUR 28-32) million.
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For further information, please contact:
David Solomon, President and Chief Executive Officer
Tel: +45 22 20 63 00
Hanne Leth Hillman, Vice President, Head of Investor Relations & Corporate Communication
Tel: +45 50 60 36 89, email: hlh@zealandpharma.com
About Zealand
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 diabetes/metabolic diseases, and its lead drug invention is lixisenatide, a once-daily GLP-1 agonist, which is licensed to Sanofi for the treatment of Type 2 diabetes. Lixisenatide is approved in Europe (February 2013) under the name of Lyxumia®, and under regulatory review in a large number of other countries globally, including in the US (NDA filed in Dec 2012) and Japan (NDA filed in June 2012).
Zealand 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, Helsinn Healthcare in chemotherapy induced diarrhea and AbbVie in acute kidney injury. For further information: www.zealandpharma.com
