Company announcement - No. 20 / 2018
Zealand Pharma - Interim report for the first half of 2018
Copenhagen, August 16, 2018 - Zealand Pharma A/S ("Zealand") (Company reg. No. 20 04 50 78), a Copenhagen-based biotechnology company focused on the discovery, design and development of innovative peptide-based medicines, today announced its financial results for the first half 2018.
"In this past quarter we took important steps towards Phase 3 initiation with both glepaglutide for short bowel syndrome and dasiglucagon for congenital hyperinsulinism, our two leading rare disease programs. We also received positive feedback from the regulatory authorities and have committed more clinical study sites for both programs across North America and Europe to engage in the trials which will commence in September," said Britt Meelby Jensen, the Company's President and Chief Executive Officer. "We are also pleased to have completed the pivotal Phase 3 trial with the HypoPal® rescue pen for severe hypoglycemia and we expect to receive the final data in September. Finally, I am encouraged by the growth of the royalty revenues."
Financial results for the first half of 2018
- Revenue of DKK 24.9 million / USD 3.9 million1 (DKK 86.7 million / USD 13.3 million2 in first half of 2017).
- Royalty revenue increased by 60% vs first half of 2017.
- There was no milestone revenue in first half of 2018 (DKK 71.3 million / USD 10.9 million2 in first half of 2017 primarily related to EU Suliqua® approval).
- Net operating expenses3 of DKK 236.9 million/USD 37.1 million1 (DKK 174.8 million /USD 26.8 million2 in first half of 2017).
- Net result of DKK -219.5 million/USD -34.3 million1 (DKK -121.5 million DKK/USD -18.6 million2 in first half of 2017).
- Cash and cash equivalents, restricted cash and securities amounted to DKK 467.4 million/USD 73.1 million1 as of June 30, 2018 (December 31, 2017: DKK 669.7 million/USD 107.9 million4).
- A restatement related to royalty revenue and royalty expenses has been incorporated in the interim report for the first half of 2018 with retrospective impact. Refer to Note 1 of the condensed consolidated interim financial statements.
Business highlights from the second quarter of 2018
- Glepaglutide for short bowel syndrome on track for Phase 3 initiation in September 2018:
- Successful End-of-Phase 2 meetings with FDA in the U.S. and CHMP scientific advisory committee in Europe.
- Phase 3 protocol submitted to authorities in U.S., Canada and Europe, including both once- and twice weekly dosing.
- Scientific presentation of PK trial demonstrating an effective half-life of ~50 hours
- Additional Phase 2 results presented at scientific conferences.
- HypoPal® rescue pen Phase 3 completed with results expected in September 2018:
- Immunogenicity Phase 3 trial met its primary objective, confirming dasiglucagon's safety profile with no treatment-induced or treatment-boosted anti-drug antibodies.
- The pivotal Phase 3 efficacy trial was completed in May, with results expected in September 2018.
- Dasiglucagon for treatment of congenital hyperinsulinism (CHI) on track for Phase 3 initiation in September 2018:
- The FDA approved the Investigational New Drug (IND) application for initiation of two Phase 3 clinical trials.
- Collaboration agreement with Roche Diabetes Care to use its Accu-Chek® Combo pump system in the Phase 3 trials.
- Phase 3 trial protocols submitted to authorities in U.S. and Europe.
- Soliqua® 100/33/Suliqua royalty increase:
- 85% increase in Soliqua® 100/33/ Suliqua® royalty revenue from first to second quarter of 2018 and 192% versus second quarter last year.
- Increased formulary coverage in the U.S., both Commercial and Medicare.
Full-year guidance for 2018
Zealand maintains its financial guidance for full-year 2018 as announced in the Company's 2017 Annual Report.
Net operating expenses in 2018 are expected to be within the range of DKK 475-495 million (USD 76-80 million). Most of the spend is related to the increased clinical development costs associated with Phase 3 trials of the Company's glepaglutide and dasiglucagon programs.
The Company expects an increase in royalty from Sanofi for sales of Soliqua® 100/33 and will provide updates as additional information is available from Sanofi. Zealand receives royalty revenue of 10% on Sanofi's net sales of Lyxumia® / Adlyxin® (lixisenatide) in countries with a valid IP protection and potentially up to USD 100 million in future commercial milestones.
Conference call today at 4 pm CET/10 am ET
Zealand's management will be hosting a conference call today at 4:00 p.m. CET/10:00 a.m. ET to present the results for the first half of 2018. Participating in the call will be President and Chief Executive Officer Britt Meelby Jensen, Executive Vice President and Chief Financial Officer Mats Blom and Executive Vice President and Chief Medical and Development Officer Adam Steensberg. The presentation will be followed by a Q&A session.
The conference call will be conducted in English, and the dial-in numbers are:
Denmark........................ +45 35 15 81 21
United Kingdom: ........... +44 (0)330 336 9411
United States: ............... +1 929 477 0324
A live audio webcast of the call, including an accompanying slide presentation, will be available via the following link, https://edge.media-server.com/m6/p/2jzj5h4j, and also will be accessible on the Investor section of Zealand's website (www.zealandpharma.com). Participants are advised to register for the webcast approximately 10 minutes before the scheduled start.
A recording of the event and a transcript will be available on the Investor section of Zealand's website after the call.
For further information, please contact:
Britt Meelby Jensen, President and Chief Executive Officer
Tel.: +45 51 67 61 28, e-mail: firstname.lastname@example.org
Mats Blom, Executive Vice President, Chief Financial Officer
Tel.: +45 31 53 79 73, e-mail: email@example.com
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq Copenhagen and New York: ZEAL) ("Zealand") is a biotechnology company focused on the discovery, design and development of innovative peptide-based medicines. Zealand has a late-stage clinical portfolio of proprietary product candidates focusing on specialty gastrointestinal and metabolic diseases. In addition, it has two marketed products, commercialized by Sanofi, and two product candidates under license collaboration with Boehringer Ingelheim.
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 LinkedIn or Twitter @ZealandPharma.