1st Quarter 2012 GE Healthcare DiaGenic collaboration: PET imaging and gene signatures
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1 1st Quarter 2012 GE Healthcare DiaGenic collaboration: PET imaging and gene signatures Henrik Lund MD PhD, CEO Magnus Sjögren, MD PhD, CMO Ruben Ekbråten, CFO
2 Disclaimer This document (the Presentation ) has been prepared by DiaGenic ASA (the Company ) exclusively for information purposes. Neither this Presentation nor any copy of it nor the information contained herein is being issued, and nor may this Presentation nor any copy of it nor the information contained herein be distributed directly or indirectly to or into, any jurisdiction in which such distribution would be unlawful or not appropriate. Recipients of the Presentation shall not reproduce, redistribute or pass on, in whole or in part, the Presentation or any of its content to any other person. The Presentation does not constitute, and should not be construed as, an offer to sell or a solicitation of an offer to buy any securities of the Company in any jurisdiction. This Presentation contains certain forward-looking statements relating to the business, financial performance and results of the Company and/or the industry in which it operates. 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Neither the issue nor delivery of this Presentation shall under any circumstance create any implication that the information contained herein is correct as of any time subsequent to the date hereof or that the affairs of the Company have not since changed, and the Company does not intend, and does not assume any obligation, except as required by law, to update or correct any information included in this Presentation. This Presentation is subject to Norwegian law, and any dispute arising in respect of this Presentation is subject to the exclusive jurisdiction of the Norwegian courts. Slide 2
3 Agenda Q presentation DiaGenic - GE Healthcare collaboration overview US licensing activity and Pharma partnering Parkinson`s disease study results Intellectual property CEO recruitment ADtect receives international science award 2012 Financials Outlook and Summary Slide 3
4 DiaGenic GE Healthcare Collaboration DiaGenic and GE Healthcare collaboration March 27 th 2012 R&D agreement to collaborate on Amyloid-PET imaging and gene signatures in Alzheimer s disease first in class study comparing gene signature and brain PET imaging. A target of 300 individuals will be recruited to the study. A majority will undergo GE Healthcare 18F-Flutemetamol amyloid-pet imaging. All subjects will be analyzed with exploratory gene expression analyses. Collaboration with the University of Lund and co-funded by Innovation Norway providing 2 million NOK. Important step change in Alzheimer market with FDA approval of first 18 F-PET ligand (AMYVID ; Eli Lilly) for detecting amyloid in the brain April 4 th. Market expected to hit 1.5 bn USD GE Healthcare has completed a phase 3 program developing 18F Flutemetamol PET ligand and expects a FDA submission in late Slide 4
5 DiaGenic and GE Healthcare to develop blood-based test for mild cognitive impairment (MCI), a disorder associated with risk for Alzheimer s Disease The collaboration is part of a broad portfolio of diagnostic solutions that GE Healthcare is developing in the Alzheimer s field. The project combines PET results with blood based gene expression to develop a diagnostic test to support optimal use of PET GE Healthcare has a global commitment to advancing clinical knowledge and providing innovations that may accelerate diagnosis of neurodegenerative diseases such as Alzheimer s disease and transform patient management The collaboration we are announcing today is part of this effort to understand and identify Alzheimer s disease in its very early stages. Finding a signature that identifies people at risk of developing the disease, may enable physicians to make more informed decisions about patient care. Jonathan Allis, General Manager, MI PET Segment, GE Healthcare Medical Diagnostics Slide 5
6 The future of Alzheimer s diagnosis as viewed by GE Healthcare Slide 6 Source: GE Healthcare presentation at JP Morgan Healthcare Conference by Pascale Witz, President & CEO, Medical Diagnostics, January 10, 2012
7 US out-licensing and Pharma partnering A series of face-to-face meetings between potential partners and DiaGenic supported by transaction Partner Ferghana, has been logged in US in Q1. These partners represent service providers (typically laboratory chains) or technology providers (platform providers). Additional interest from large pharma players with ongoing AD clinical programs. Slide 7
8 DiaGenic aim to develop and commercialize products in collaboration with partners The business model of DiaGenic: Out-license the Company s blood based diagnostic portfolio, technology and related IP to recognized global diagnostic players or laboratory chains Enter into R&D collaborations with Pharma and Imaging companies to develop biomarkers and companion diagnostics Short term revenues are expected to come from co-development agreements in the form of up-front and milestone payments In the medium to long term the goal is to establish sustainable revenue streams from product sales to partners and royalties CNS portfolio R&D collaborations Biomarkers & Companion Diagnostics Pharma Imaging Exclusive license Development of Molecular Diagnostics Global Diagnostic Supplier Laboratory Chains Breast cancer Exclusive license Development of Molecular Diagnostics Global Diagnostic Supplier Laboratory Chains Slide 8
9 Pharma partnering Estimated launch of Alzheimer s drugs (source DiaGenic) PF Bapineuzumab Ro EHT0202? Solanezumab Begacestat Gammagard BMS DISEASE MODIFYING SYMPTOMATIC SB EVP6124 Gantenerumab CERE-110 GSK PBT2 Anticipated loss of exclusivity in US ELND005 ACC-001 CHF-5074 Namenda Exelon TTP-854 Interest for DiaGenic s Alzheimer s products from large pharma Large pharmas developing AD drugs Imaging Diagnostic Company Interest for collaboration to identify progression biomarker for Parkinson s disease Slide 9
10 Nature comments on DiaGenics pharma partnering Nature Reviews / Drug Development, Impact Factor 28,7 which is among the top in the world DiaGenic s technology and biomarkers recognized as innovative solution provider for Pharma in Nature Reviews Slide 10
11 DiaGenic presented high accuracy (88%) in diagnosing Parkinson s disease in European multicenter trial The trial includes 79 PD patients, 109 matched controls was tested utilizing a 700 probes approach. Patients from DiaGenic s biobank of 900 PD patients from Norway, Sweden, Germany and Italy. Dialogues with partners providing imaging diagnostics have been initiated. Imaging in the diagnosis of Parkinson s disease is standard procedure. DiaGenic s gene expression signature is encouraging and may act as a co-diagnostic to imaging. Several million tests performed annually - early diagnosis is however insufficient with existing procedures. To date, there are few alternatives and DiaGenic give priority to provide an innovative improvement to the diagnosis of PD. Slide 11
12 DiaGenic reports completion of data collection and genetic analyses in a unique study on familial Parkinson s disease These individuals will in most cases develop Parkinson s disease at an early age and the study will investigate their blood for gene signatures before the onset of PD. DiaGenic has finalized data collection and database lock of a blinded study in a Norwegian cohort of 80 patients with familial Parkinson s disease (PD). Slide 12
13 Intellectual Property New breast cancer patents move from Notice of Allowance to approval Notice of Allowance US family 3 breast cancer patent USPTO (11/628,300) has now been granted. The claims cover the use of some important gene sequences or the related proteins in blood sample for detection and monitoring of breast cancer in the US. The patent will be valid until The family 2 patent PCT/GB03/ has also been granted by ARIPO (African Regional Intellectual Property Organization) in the quarter. DiaGenic has been granted world-wide trademarks for its key brands ADtect, BCtect, PDtect and MCItect US, EU and ROW Covers a total of 30 countries Slide 13
14 CEO recruitment CEO change April 17 th 2012 Erik Christensen resigned the Chief Executive Officer position April 17 th and will support DiaGenic as a consultant. Henrik Lund appointed interim Chief Executive Officer. Recruitment process for new CEO initiated Slide 14
15 International award for ADtect in JAD DiaGenic receive Journal of Alzheimer s disease 2012 award for best article 2011 on ADtect, May 2nd The DiaGenic scientific article A Novel Blood Test for the Early Detection of Alzheimer s Disease (J Alzheimers Dis 23, , 2011) is awarded by Journal of Alzheimers disease (JAD) as the best publication of the year Price suported by IOS Press and ELAN Pharmaceuticals. Slide 15
16 Slide 16 Journal of Alzheimer s disease 2012 award for best article 2011 on development of ADtect
17 Slide 17 1 st quarter 2012 financials
18 Finance, Income Income (thousand NOK) Operating revenue in Q1 12: Pilot sales of ADtect in Spain NOK 23k Operating revenue in Q1 11: Pharma R&D revenue from milestones achieved, which will vary from quarter to quarter Research grants in Q1 totalled NOK 785k - Q1 11 Q2 11 Q3 11 Q4 11 Q1 12 Operating revenue Grants Innovation Norway granted NOK 2 million to the GE R&D collaboration project Reduction of operating cost over the duration of the project Slide 18
19 Finance, Profit & Loss P&L 1Q (thousand NOK) Operating Cost (thousand NOK) 1Q 12 1Q Q 11 11,231 1Q 12 9,426 Revenue 23 1, Grants Operating Cost net of Grants 9,426 11, Operating loss (9,403) (9,623) Net finance Net income (8,980) (9,046) Q1 11 Q2 11 Q3 11 Q4 11 Q1 12 Cost of sales Salaries and related Depreciation and Write downs Other operating cost Slide 19
20 Finance, Cash position 100,0 90,0 80,0 70,0 60,0 50,0 40,0 30,0 20,0 10,0 Cash and Cash equivalents (million NOK) Cash balance end of March 2012: NOK 48 million No significant changes in cost level expected for 2012 compared with Q1 '11 Q2 '11 Q3 '11 Q4 '11 Q1 '12 Cash 86,7 76,1 66,3 58,9 48,1 Slide 20
21 Slide 21 Outlook & Summary
22 Post quarter outlook CEO recruitment completion Study start of 18F PET study with GE Healthcare and first patient scanned with amyloid PET Partnering discussion with large pharma players with ongoing AD clinical programs US out-licensing activities of DiaGenic s products with Ferghana Partners Results from Parkinson s disease LRRK2 study Slide 22
23 DiaGenic ASA Grenseveien 92, N-0663 Oslo, Norway Tel Mail:
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