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Zealand presentation q3 2011_interim_tc
1. Q3 2011 Interim report
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2. DISCLAIMER
This presentation does not constitute or form part of and should not be construed as, an offer to sell or issue or the solicitation of an offer to buy or acquire securities
of Zealand Pharma A/S in any jurisdiction or an inducement to enter into investment activity. No part of this presentation, nor the fact of its distribution, should form
the basis of, or be relied on in connection with, any contract or commitment or investment decision whatsoever.
This presentation contains forward-looking statements that reflect management’s current views with respect to certain future events and potential financial
performance. Although Zealand Pharma believes that the expectations reflected in such forward looking statements are reasonable, no assurance can be given that
such expectations will prove to have been correct. Accordingly, results could differ materially from those set out in the forward-looking statements as a result of
various factors many of which are beyond Zealand Pharma's control.
This presentation does not imply that Zealand Pharma has undertaken to revise these forward-looking statements, beyond what is required by applicable law or
applicable stock exchange regulations if and when circumstances arise that will lead to changes compared to the date when these statements were provided.
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3. HIGHLIGHTS OF Q3 2011 AND THE PERIOD THEREAFTER
Main pipeline achievements
Lyxumia® (lixisenatide) – Completing Phase III, now in registration phase in Europe
• October - Sanofi submitted an MAA in Europe for Lyxumia® 1) (lixisenatide) with the intended indication to achieve
glycemic control in adults with type 2 diabetes not adequately controlled on current treatment and as add-on or in
combination with a wide range of therapies, including in combination with basal insulin
• September – Positive results from the sixth consecutive Phase III GetGoal study, GetGoal-F1, presented at the annual
EASD meeting in Lisbon, showing that lixisenatide is effective and safe with a simplified once-daily dosing regimen
• ZP1848 (IBD) and danegaptide (CV) – Preparations advancing for Phase IIa
• Preparations are advancing towards Phase IIa development for both ZP1848 in Inflammatory Bowel Disease and
danegaptide in the area of cardiac protection
• ZP2929 for Type-2 diabetes and obesity, licensed to Boehringer Ingelheim
• Preparations advancing for the start of first clinical study
Other business events
• New Clinical and Scientific Advisory Board established
• Five renowned experts to continuously advice and collaborate closely with Zealand for an optimal pipeline
prioritization
1) Lyxumia® is the intended trademark for lixisenatide 3
4. FIRST 9 MONTH 2011: FINANCIAL OVERVIEW
Consolidated Income Statement
Q1-Q3 2011 Q1-Q3 2010
DKK’000 (IFRS) (IFRS)
Revenue 119,968 83,630
Research and development expenses (89,044) (94,310)
Administrative expenses (25,327) (35,116)
Other operating income 23,587 191
Operating Result 29,184 (45,605)
Net financial items 3,358 3,649
Profit / Loss before tax 32,542 (41,956)
Tax expenses 0 0
Profit for the period 32,542 (41,956)
Cash position
• Zealand Pharma is sufficiently funded to sustained profitability via its cash
reserves and expected payments under its partnership agreements
• End September 2011: Cash position: DKK 441.9m (€59.3m)
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5. FINANCIAL GUIDANCE FOR 2011 RAISED
• Zealand Pharma has raised its 2011 full year financial guidance:
– Expecting DKK 170 (EUR 23) million in revenues and other operational income from
partnership agreements against earlier guidance of DKK 150 (EUR 20) million
– Maintaining expectations for total operating expenses of approximately DKK 170
(EUR 23) million
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6. PIPELINE: FIRST PRODUCT IN REGISTRATION PHASE
PARTNER/
INDICATION DISCOVERY PRECLINICAL PHASE I PHASE II PHASE III REGISTRATION
OWNERSHIP
Type 2 diabetes Lyxumia® (Lixisenatide)
Type 2 diabetes Lixisenatide + Lantus® ( )
*
Diabetes/Obesity ZP2929
Chemotherapy and
Radiotherapy Induced Elsiglutide (ZP1846)
Diarrhea
Inflammatory Bowel
Disease
ZP1848
Atrial Fibrillation Danegaptide
Acute Kidney Injury ZP1480
Metabolic Disorders
Gastrointestinal Disorders
Cardiovascular Disorders
(*) Positive results from two clinical Phase III studies of lixisenatide and Lantus® in “free combination” announced as part of the GETGOAL programme for Lyxumia®.
Sanofi expects to initiate further Phase III studies with the combination in early 2013 based on the pen device intended for commercial use.
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7. EXPECTED KEY NEWS FLOW – NEXT 12 MONTHS
• Lyxumia® (lixisenatide) – New GLP-1 product for Type 2 diabetes (Sanofi)
-- Completion of “free combination” Lyxumia®/Lantus® Phase III study
-- Completion of remaining Phase III GETGOAL studies (Q4 2011 and H1 2012)
-- US filing (Q4 2012)
-- EMA MAA response
• Lixisenatide/Lantus® combination pen – Type 2 diabetes
-- Advance preparations for Phase III with commercial pen device (early ’13)
• ZP2929 – Diabetes and obesity (Boehringer Ingelheim)
-- Progress towards first human dosing
• Elsiglutide (ZP1846) – Chemotherapy induced diarrhea (Helsinn)
-- Phase Ib results and start of a Phase IIa study in colon cancer patients
• ZP1848 in IBD - Danegaptide in CV disease
-- Initiation of Phase IIa studies
• Other expected pipeline news
-- ZP1480 – Decision on next step following positive Phase IIb results
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