Company announcement - No. 43 / 2016
Full year revenue guidance remains unchanged and expected lower net operating expenses
Copenhagen, 9 November 2016 - Zealand Pharma A/S ("Zealand") (CVR no. 20 04 50 78) today reported financial results for the period, 1 January - 30 September 2016. The financial guidance on revenue for 2016 remains unchanged while the guidance on net operating expenses has been reduced.
Financial results for the first nine months of 2016
- Revenue of DKK 54.3 million (164% increase vs. 2015)
- Net operating expenses of DKK 220.9 million (25% increase vs. 2015)
- Net loss of DKK 206.7 million (13% increase vs. 2015)
- The cash position amounted to DKK 381.9 million at 30 September 2016 (30 September 2015: DKK 453.9 million). This excludes DKK 135.5 million in net proceeds raised in new share capital paid on 4 October 2016
Business highlights for Q3 2016:
- Lixisenatide approved by the FDA as Adlyxin(TM) triggering a $5 million milestone
- FDA regulatory decision on iGlarLixi in the U.S. extended to November 2016
- Positive Phase II results for dasiglucagon for treatment of acute, severe hypoglycemia
- Gross proceeds of DKK 143 million / $22 million were raised after a successful private placement of new shares to fund continued development of glepaglutide and dasiglucagon
Britt Meelby Jensen, President and CEO of Zealand, commented on the report:
"During the third quarter, we continued to advance our own clinical programs, with solid progress in patient recruitment for the glepaglutide Phase II trial and notably dasiglucagon with positive Phase II results for rescue treatment of acute severe hypoglycemia. In terms of our partnered programs, we are excited to have the first ever Zealand invented product approved in the U.S, the GLP-1 receptor agonist lixisenatide under the brand name AdlyxinTM. The FDA decision on iGlarLixi, the fixed-dose combination product with basal insulin, was extended by three months, from August to November, so we are close to reach this important milestone."
Out-licensed portfolio highlights
AdlyxinTM/Lyxumia® (lixisenatide, GLP-1 receptor agonist)
Royalty revenue on Sanofi's sales of Lyxumia® amounted to DKK 19.0 million / €2.6 million in the first nine months of 2016. Lyxumia® is approved in more than 60 countries and has been launched by Sanofi in 45 of these.
In July 2016, lixisenatide was approved by FDA under the brand name Adlyxin(TM) which triggered a DKK 33.5 million / $5 million milestone payment from Sanofi.
iGlarLixi (fixed-ratio combination of lixisenatide and Lantus®)
On 19 August 2016, the U.S. FDA extended the PDUFA goal date for Sanofi's New Drug Application (NDA) for iGlarLixi by three months. A U.S. regulatory decision on iGlarLixi is now expected before the end of November 2016. iGlarLixi is also undergoing review by the European Medicines Agency (EMA) with a regulatory decision for Europe expected in Q1 2017.
Glucagon/GLP-1 dual agonist and undisclosed biological drug candidate for diabetes and/or obesity
Zealand has two preclinical peptide programs under license collaborations with Boehringer Ingelheim. One covers glucagon/GLP-1 dual agonists for the treatment of diabetes and/or obesity, and the other covers novel compounds against an undisclosed biological target for the treatment of obesity and/or diabetes.
Under both collaborations a lead candidate is being progressed towards start of clinical Phase I development in 2017.
Elsiglutide (GLP-2 analog for Chemotherapy induced diarrhea)
Results reported from a Phase IIb trial in May 2016 showed that elsiglutide reduced chemotherapy-induced diarrhea (CID) in colorectal cancer patients, however not sufficiently to meet the primary efficacy endpoint for the trial.
After evaluating the Phase IIb results, Helsinn has informed Zealand that in 2017 they will initiate one or more exploratory clinical trials in alternative patient settings with a higher incidence of CID, which, if successful, could lead to further development of elsiglutide.
Proprietary pipeline highlights
Glepaglutide[1] (GLP-2 analog for short bowel syndrome)
The ongoing Phase II Proof-of-Concept trial continues to progress according to plan, with results expected mid-2017.
Dasiglucagon[2] (single dose for acute, severe hypoglycemia)
In August 2016, Zealand announced positive results from a clinical Phase II trial with dasiglucagon, supporting its potential as a ready-to-use rescue pen to treat acute, severe hypoglycemia ("insulin shock") associated with insulin therapy in diabetes.
Zealand is in preparation for submission of the data to FDA with the aim of entering the next development steps in 2017.
Dasiglucagon[2] (multiple dose use in a dual hormone artificial pancreas system)
In June 2016, a non-exclusive collaboration was announced with U.S. based Beta Bionics. The objective is to advance the development of a first-in-class dual-hormone artificial pancreas system to offer diabetes patients on insulin therapy, an easier and better way to control and manage their disease.
Later in 2016, Zealand plans to initiate a clinical trial with Beta Bionics and is also planning a PK/PD trial for multiple dose dasiglucagon.
ZP2929 (glucagon/GLP-1 dual agonist)
Zealand has decided to pause development activities on ZP2929 and does not plan to continue development of this product candidate without a partner. This decision will enable Zealand's development organisation to fully focus on the three mid-to-late phase development programs, glepaglutide and the two dasiglucagon programs, in line with Zealand's strategy.
Revised financial guidance for 2016
Zealand maintains its revenue guidance for the full-year of revenues of up to DKK 200 million in the form of milestone payments from partners and a growing royalty revenue from Sanofi's sales assuming a launch of AdlyxinTM in the U.S. late 2016.
Net operating expenses in 2016 are expected at a range of DKK 320-330 million, 6-8% lower than previously forecasted, and operating loss before royalty income/expenses is therefore expected at a range of DKK 120-130 million. The decrease in expected net operating expenses relates to clinical studies as well as a tight cost control.
Conference call on Wednesday, 9 November 2016 at 2 pm CET / 8 am EDT
On the day of release, Zealand's senior management will host a conference call at 2 pm CET to present the interim report for the first nine months of 2016. Participating in the call will be Britt Meelby Jensen, President and Chief Executive Officer, Mats Blom, SVP and Chief Financial Officer and Adam Steensberg, SVP and Chief Medical and Development Officer. The presentation will be followed by a Q&A session.
The conference call will be conducted in English and the dial-in numbers are:
DK standard access +45 38 32 28 69
UK and international +44 (0) 20 3427 1906
U.S. (free dial-in) +1 646 254 3362
Kindly inform the operator of the following passcode: "Zealand Pharma" or 9968202.
A live audio webcast of the call including an accompanying slide presentation will be available via the following link, http://edge.media-server.com/m/p/spwqjphn accessible also from the company's website (www.zealandpharma.com). Participants are advised to register for the webcast approximately 10 minutes before the start.
A replay of the event will be made available from the Investor section of Zealand's website following the call.
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For further information, please contact:
Britt Meelby Jensen, President and Chief Executive Officer
Tel: +45 51 67 61 28, email: bmj@zealandpharma.com
Mats Blom, Senior Vice President and Chief Financial Officer
Tel: +45 31 53 79 73, email: mabl@zealandpharma.com
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) ("Zealand") is a biotechnology company focused on the discovery, design and development of innovative peptide-based medicines. Zealand has a portfolio of medicines and product candidates under license collaborations with Sanofi, Boehringer Ingelheim and Helsinn and a pipeline of proprietary product candidates, which primarily target specialty diseases with significant unmet needs.
The company's first invented medicine, lixisenatide, a once-daily prandial GLP-1 analog for the treatment of type 2 diabetes, is licensed to Sanofi. Lixisenatide is marketed as Lyxumia® outside the United States and approved as AdlyxinTM in the United States. Lixisenatide has been developed in a fixed-ratio combination with Lantus® (insulin glargine) which product is under regulatory review in the United States and in Europe.
Zealand's proprietary pipeline includes: Dasiglucagon* (ZP4207) as single-dose rescue treatment for acute, severe hypoglycemia (Phase II); Glepaglutide* (ZP1848) for treatment of short bowel syndrome (Phase II); Dasiglucagon* (ZP4207) multiple-dose version intended for use in a dual-hormone artificial pancreas system for better hypoglycemia control and diabetes management (in preparation for Phase II); and other earlier stage clinical and preclinical peptide therapeutics.
Zealand is based in Copenhagen (Glostrup), Denmark. For further information about the company's business and activities, please visit www.zealandpharma.com or follow Zealand on Twitter @ZealandPharma.
* Dasiglucagon and glepaglutide are proposed International Nonproprietary Names (pINN)