Zealand Pharma A/s · OMXCOP:ZEAL
Zealand Pharma A/s — H1 2018 Earnings Presentation
16 slides from Zealand Pharma A/s's earnings presentation, Aug 17, 2018
Slide 1: Forward-looking statements
Forward-looking statements This presentation contains information pertaining to Zealand Pharma A/S (“Zealand"). Neither Zealand nor its management, directors, employees or representatives make any representation or warranty, express or implied, as to the accuracy or completeness of any of the inform
Slide 2: Agenda
Agenda Introduction By Britt Meelby Jensen, President & CEO Financial highlights By Mats Blom, EVP & CFO Business highlights and outlook By Britt Meelby Jensen, President & CEO Q&A
Slide 3: Business highlights in Q2 2018
Business highlights in Q2 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, inclu
Slide 4: Two marketed products and an attractive late-stage clinical pipeline
Two marketed products and an attractive late-stage clinical pipeline Marketed products Partnered with Sanofi Soliqua® 100/33 / Suliqua® GLP-1 / Basal insulin fixed-dose combination Lyxumia® / Adlyxin® Once-daily GLP-1 analog Preclinical Phase 1 GLP-1/GLP-2 Dual agonist Phase 2 Phase 3 GIP/GLP-1/ glu
Slide 5: Financial highlights
Financial highlights By Mats Blom, EVP & CFO
Slide 6: In Q2, U.S. Soliqua 100/33 sales grew 85% over the previous quarter
In Q2, U.S. Soliqua® 100/33 sales grew 85% over the previous quarter 1 Managed Markets Insight & Technology, LLC; 2 Global development and commercial rights are owned by Sanofi; 3 IMS data, calculated average based on weekly prescriptions (TRx) Increasing royalties from Sanofi based on Soliqua® 100/
Slide 7: H1 2018 financial results in line with expectations
H1 2018 financial results in line with expectations DKK ‘000 H1 2018 H1 2017 Restated FY 2017 Restated Income statement Revenue (royalties and milestone payments) 24,858 86,710 136,322 Royalty expenses -3.356 -11,481 -14,163 Research and development expenses -216.172 -152,145 -324,667 Administration
Slide 8: Cash position continues to be strong
Cash position continues to be strong DKK ‘000 H1 2018 Statement of financial position Cash and cash equivalents 387,022 Restricted cash 6,074 Securities 74,315 Total assets 522,130 Share capital (‘000 shares) 30,751 Equity 316,237 Equity ratio 0.61 Royalty bond 143,435 Total cash position of DKK 467
Slide 9: Short Bowel Syndrome: glepaglutide once-weekly dosing and Phase 3 ready
Short Bowel Syndrome H1 2018 Phase 2 results presented at scientific conferences in the U.S. underscore the potential for glepaglutide to alleviate the burden of living with SBS Successful End-of-Phase 2 meeting with the FDA and CHMP Advisory meeting Phase 3 protocol submitted to authorities in U.S.
Slide 10: Dasiglucagon HypoPal rescue pen – Phase 3 results ready soon
Dasiglucagon HypoPal® rescue pen – Phase 3 results ready soon Severe hypoglycemia H1 2018 First Phase 3 trial successfully met its primary objective confirming dasiglucagon's safety profile with no treatment-induced or treatment-boosted anti-drug antibodies Pivotal Phase 3 efficacy trial was complet
Slide 11: Dasiglucagon for Congenital Hyperinsulinism – Phase 3 to start in September 2018
Congenital Hyperinsulinism Ultra rare pediatric disease associated with persistent episodes of severe hypoglycemic events Dasiglucagon has potential to transform the life of these children and prevent need for major pancreatic surgery H1 2018 FDA approved IND for initiation of two Phase 3 clinical t
Slide 12: Dasiglucagon for pump – FDA clarity on regulatory path
Dasiglucagon for pump – FDA clarity on regulatory path Dasiglucagon for dual-hormone pump therapy H1 2018 Pump device partner Beta Bionics has received IDE approval from FDA1 New clarity from the FDA on the path towards Phase 3 indicating, considerable less effort than earlier expected Next steps Ph
Slide 13: Summary and outlook
Summary and outlook By Britt Meelby Jensen, President & CEO
Slide 14: Closing remarks: two exciting months ahead
Dasiglucagon HypoPal® rescue pen Pivotal Phase 3 results in September 2018 Initiation of Phase 3 in two rare disease indications: Glepaglutide for short bowel syndrome Dasiglucagon for congenital hyperinsulinism Two exciting months ahead Closing remarks Progress in all four late stage clinical progr
Slide 15: Upcoming investor presentations
Upcoming investor presentations Morgan Stanley Global Healthcare Conference, New York September 12-14, 2018 J.P. Morgan Cazenove Pan-European Small/Mid Cap Conference, London September 11-13, 2018 InvestorDagen, Copenhagen September 18, 2018 Jefferies Healthcare Conference, London November 14-15, 20
Slide 16: Zealand Pharma – Upcoming investor presentations
ZEALAND PHARMA Upcoming investor presentations Morgan Stanley Global Healthcare Conference, New York September 12-14, 2018 J.P. Morgan Cazenove Pan-European Small/Mid Cap Conference, London * September 11-13, 2018 } InyestorDagen, Copenhagen September 18, 2018 a Jefferies Healthcare Conference, Lond