Company update. March 2012

Transcription

1 Company update March 2012

2 Oncology-focused biopharmaceutical company Product candidates with strong competitive profiles Integrative approach through combination of therapeutics and diagnostics Transition from R&D to commercially driven business Important clinical and commercial milestones in the next months Development success Phase I II III Significant sales potential Deals & Alliances Products & Technologies REDECTANE REDECTANE ~ $100m RENCAREX RENCAREX ~ $500m MESUPRON MESUPRON ~ $1bn WX-554 Therapeutics (Rx) + Diagnostics (Dx) + Customer Specific Research (Cx) 2

3 Transition from R&D to commercially driven business Positioning in three segments Therapeutics (Rx) Diagnostics (Dx) Customer Specific Research (Cx) Milestones and Royalties : Prometheus, Esteve (RENCAREX) Licensing: MESUPRON, RENCAREX for RoW Revenues: diagnostic tests (WILEX Inc.) Milestones and Royalties: IBA (REDECTANE) Co promotion REDECTANE Revenues: ADC-Licensing Revenues: Preclinical Services WX: Revenues and other income 3

4 Cx Dx Rx Key Achievements 2011 RENCAREX US commercialisation rights to Prometheus Laboratories Inc. Fast track designation from FDA IDMC recommendation MESUPRON WX-554 & WX-037 Patient recruitment Phase II breast cancer trial completed Phase I with oral WX-554 in healthy volunteers started Pre-clinical development (GMP and toxicity studies) for WX-037 REDECTANE Pre-BLA meeting and follow up meeting with FDA In-vitro diagnostics ADC + CSR WILEX Inc. ISO certification US marketing and distribution agreement with ALPCO Integration of Heidelberg Pharma into the Group completed Material Transfer Agreements with third companies for ADC 4

5 Pipeline status 5

6 RENCAREX : registration trial proceeds directly to final analysis (Rx) Therapy for adjuvant treatment of clear cell Renal Cell Carcinoma (ccrcc) No drug approved by FDA / EMA in non-metastatic ccrcc Marketing and co-development deals Esteve for Southern Europe (2004) and Prometheus for the USA (2011) Phase III ARISER trial: 864 renal cancer patients enrolled Double-blind, placebo-controlled study in 142 sites in 14 countries IDMC recommendation in Q Cancel the interim analysis and proceed straight to the final analysis Trial matured, recurrence rate further declined (Currently 358 relapses reported by the local trial centres) Protocol amendment approved by FDA in Q Final analysis results may be expected in Q Possible filing in EU and US in H

7 RENCAREX : New partnership with Prometheus since April 2011 (Rx) WILEX granted exclusive US commercialisation rights for RENCAREX to Prometheus Laboratories Inc. Deal terms $19 million in cash upon signing Option to either draw $15 million in cash six months after signing OR $20 million in cash twelve months after signing OR receive European commercial rights to an undisclosed product Milestone payments Co-funding for the ongoing development of RENCAREX Royalties on US net sales of RENCAREX RCC and potential development in further indications Deal valued up to $145 million in cash for upfront, milestone payments and reimbursed costs plus royalties for US only 7

8 MESUPRON : phase II in breast cancer study expected 2012 (Rx) MESUPRON inhibits the Urokinase-type Plasminogen Activator (upa) system Oral small molecule for novel non-cytotoxic, anti-metastatic approach in cancer therapy To specifically block tumour metastasis in solid cancers Phase II trial in pancreatic cancer with 95 patients successfully completed and data published in June 2010 Combination therapy with Gemcitabine, 3-arm, randomised study One year PFS rate improved by 66%, one year OS rate increased by 49% Median overall survival in months improved by 26% Phase II trial in breast cancer 132 patients in 20 centres in 5 countries (Belgium, Brazil, Germany, Israel and USA) Combination therapy with Capecitabine, double-blind design First line therapy for HER2 receptor negative metastatic breast cancer Completion of patient recruitment in Q Study data (PFS) expected 2012 Worldwide partnership planned 8

9 Early stage small molecule programmes (Rx) WX-554 oral small molecule MEK inhibitor Mitogen-activated protein kinase (MEK) plays a central role in signal transduction MEK signalling pathway is over expressed in more than 30% of cancers, resulting in increased tumour growth and proliferation Phase I trial: orally administered in healthy volunteers, completed in Q Phase I/II trial: orally administered in cancer patients; planned for 2012 WX-037 oral small molecule PI3K inhibitor Phosphatidylinositol-3-kinase/protein kinase (PI3K) signalling pathway sends a growth signal to the nucleus of a tumour cell Development candidate selected and preclinical development underway GMP (good manufacturing practice) synthesis development started First toxicity studies of WX-037 completed Part of the m4 Biotech Cluster Personalised Medicine and Targeted Therapies initiative Funding commitment of up to 2.6 million 9

10 REDECTANE : Discussion of development and approval process with the FDA (Dx) First in class diagnostic imaging agent Antibody Girentuximab radio-labelled with 124I for diagnosis of clear cell renal cell carcinoma (ccrcc) pre surgery Worldwide commercial partnership with IBA US Phase III trial with 226 patients in 14 centres completed in May 2010 REDECTANE with PET/CT proves to be superior to CT Specificity: highly statistical value p<0.001, Sensitivity: statistical significance with p REDECTANE with PET/CT in comparison to an arbitrary value of 75% for specificity and sensitivity Specificity of 87% (p=0.057), Sensitivity of 86% (p 0.002) Pre BLA Meeting with FDA in Q Suggestion for an outcomes based study to provide additional evidence of clinical benefit Type C Meeting with FDA in Q Scheduling of a second trial and the options to conduct an outcomes-based study or a confirmatory study Advisory Committee meeting suggested by FDA REDECTANE PET-CT* 10

11 In vitro diagnostics from WILEX Inc. (Dx) Manufacturing and sale of biomarker tests in oncology Bioanalytical methods designed to select patients for therapy Assessment how patients will respond to a specific medical treatment Monitoring of patient s treatment and outcome FDA-registered in vitro diagnostic tests for patient use HER2/neu ELISA* and CA IX IHC** ELISA assays for Research Use Only CA IX, upa, PAI-1, EGFr, TIMP ISO certifications for WILEX Inc. s production facility in Cambridge (August 2011) Prerequisite to manufacture and distribute biomarker tests Exclusive co-marketing and distribution agreement with ALPCO Diagnostics (October 2011) Commercialisation of the Serum HER2/neu ELISA test in North America (USA and Canada) Walter Carney, Ph.D. joins WILEX Inc. as CSO (February 2012) 20 years at Oncogene Science (OSI Pharmaceuticals, Bayer HealthCare and Siemens Healthcare Diagnostics). * Enzyme-Linked ImmunoSorbent Assay, ** immuno histochemistry, 11

12 Customer Specific Research at Heidelberg Pharma (Cx) ADC technology Combining specificity of an antibody & efficacy of the toxin, that kills the tumour cell ADCs target dividing and quiescent tumour cells Preclinical ADC platform business on a contract basis Optimisation of the various linker structures for antibody and toxin Signing of material transfer agreements with third parties as a preliminary stage for collaboration tumour cell Preclinical contract research business (CSR) Tumour implantation models Bioanalytics, Cell Biology, Pharmacology Molecular biology Service business reported increased sales in

13 WILEX Group s combined offering Focussed on target and indication with various mode of actions for personalised cancer treatment CA IX as an example for an integrative approach through combination of therapeutics and diagnostics RENCAREX (adjuvant) Therapeutics (Rx) Heidelberg Pharma Girentuximab-ADC Target: CA IX Indication: RCC REDECTANE (PET/CT imaging) Diagnostics (Dx) Oncogene Science CA IX IHC/ELISA 13

14 Financials WILEX Group 14

15 Shareholders and Equity Shareholder structure Boards (direct ownership) 2,09% Recent financing 9.9m capital increase 02/2012 Freefloat 31,02% Merlin Funds 3,44% TVM Funds 3,73% UCB 15,71% dievini and affiliated companies* 44,01% Stock Exchange data FSE Prime Standard (Ticker symbol: WL6) 24,814,963 shares registered ( 1.00/per share) Financial calendar 12 April month Financial Report May 2012 Annual General Meeting July 2012 Half-yearly Financial Report October month Financial Report 2012 *dievini Hopp BioTech holding GmbH & Co. KG + Verwaltungsgesellschaft des Golf Club St. Leon-Rot mbh As of 3 February

16 Financial review 2011 million 2011 Guidance 2011 reported Sales revenue & other income Operating expenses Operating result (16.0) (20.0) (13.4) Total funding requirement Funds required per month Sales revenues & other income rose considerably Operating expenses lower than expected Operating result improved Less cash funding required Segment results '000 Rx Dx Cx Sales revenue Other income Operating expenses (16.5) (5.9) (2.9) Net loss for the year (7.4) (5.8) (0.8) WILEX Group financials include Heidelberg Pharma from 17 March

17 Financial guidance 2012 in m Actual 2011 Guidance 2012 Sales revenue and other income Operating expenses Operating result (EBIT) (13.4) (10.0) (14.0) Total funding requirement Funds required per month Guidance comprises WILEX AG, WILEX Inc. and Heidelberg Pharma AG 17

18 Cx Dx Rx News flow 2012 RENCAREX Decision: product or $15m / $20m cash from Prometheus Full study results of final DFS analysis expected in Q MESUPRON Breast cancer Phase II trial PFS data expected 2012 WX-554 & WX-037 Start Phase I with oral WX-554 in cancer patients Preclinical research and development for WX-037 will continue REDECTANE FDA feedback on Advisory Committee Decision on further development and approval process In-vitro diagnostics Increase marketing activities and revenue ADC + CSR Third-party ADC collaborations Increase sales revenue 18

19 Broad portfolio and strong partners Product Technology Indication Research Preclinical Clinical development Market Partner Phase I Phase II Phase III RENCAREX Antibody (therapeutic) non-metast. ccrcc* (Southern Europe) (USA) MESUPRON upa inhibitor Pancreatic cancer Breast cancer WX-554 MEK inhibitor Cancer (ww)** WX-037 PI3K inhibitor Cancer (ww) 2 Antibodies Cancer (ww) REDECTANE Antibody (diagnostic) Renal mass (ww) Diagnostic tests ELISA/IHC HER-2, CAIX, upa, PAI-1, EGFr; VEGF etc. WILEX Group ADC Platform Antibody drug conjugates Cancer WILEX Group *clear cell Renal Cell Carcinoma, non-metastatic, ** worldwide 19

20 Safe harbour Forward looking statements This communication contains certain forward-looking statements, relating to the Company s business, which can be identified by the use of forward-looking terminology such as estimates, believes, expects, may, will should future, potential or similar expressions or by general discussion of strategy, plans or intentions of the Company. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results of operations, financial condition, performance, or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, among others, the following: uncertainties related to results of our clinical trials, the uncertainty of regulatory approval and commercial uncertainty, reimbursement and drug price uncertainty, the absence of sales and marketing experience and limited manufacturing capabilities, attraction and retention of technologically skilled employees, dependence on licenses, patents and proprietary technology, dependence upon collaborators, future capital needs and the uncertainty of additional funding, risks of product liability and limitations of insurance, limitations of supplies, competition from other biopharmaceutical, chemical and pharmaceutical companies, environmental, health and safety matters, availability of licensing arrangements, currency fluctuations, adverse changes in governmental rules and fiscal policies, civil unrest, acts of God, acts of war, and other factors referenced in this communication. Given these uncertainties, prospective investors and partners are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forward-looking statements to reflect future events or developments. This material is not intended as an offer or solicitation for the purchase or sale of shares of WILEX AG. This material may not be distributed within countries where it may violate applicable law. WILEX AG Grillparzerstr Munich, Germany Tel.: +49 (0) Fax: +49 (0) Website: Corporate Communications Katja Arnold (CIRO) investors[at]wilex.com Tel.: +49 (0) ISIN: Symbol: DE WL6 Reuters: WL6G.DE Bloomberg: WL6G.GR 20