Developing & Commercializing Targeted Small Molecule Drugs in Cancer
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1 Developing & Commercializing Targeted Small Molecule Drugs in Cancer
2 SAFE HARBOR STATEMENT 2 Forward-looking statements made in the course of this presentation are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of The audience is cautioned that such forward looking statements involve risks and uncertainties, including those described in our annual report filed on form 10-K for the year ended June 30, 2015, and other filings of the Company with the Securities and Exchange Commission, which may cause the Company's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements.
3 NEW PARTNERSHIP ENHANCES BINIMETINIB & ENCORAFENIB VALUE 3 Broad global clinical program conducted with oncology powerhouse Novartis Three global Phase 3 trials nearing completion Top-line results from NEMO anticipated before the end of 2015 and from COLUMBUS in the first half of 2016 Multiple regulatory submissions planned in exploratory studies, including combinations with novel agents, on-going Trials designed to inform potential life-cycle opportunities Array s Selection Criteria for Strong European Commercial Partner was Met by Pierre Fabre Company with Europe as leading geographic priority with robust emerging market capability to provide scale to the collaboration Company with significant footprint in Oncology Development, Sales & Marketing Company willing to commit significant resources to ensure binimetinib & encorafenib success Company providing robust downstream economics (royalties) for ready-to-file products
4 STRATEGIC COLLABORATION WITH PIERRE FABRE ONCOLOGY: BINIMETINIB & ENCORAFENIB 4 Pierre Fabre Oncology Pierre Fabre Oncology is supported by over 1,000 employees with a strong focus on European markets Focused on the discovery, development and commercialization of proprietary pharmaceuticals Significant commitment and track record in pharmaceutical R&D, developing products for patients afflicted with lung, breast and other solid tumors and hematological cancers 30 years of innovation with cancer therapeutics 2014 oncology sales surpassed $200 million on the strength of Oral Navelbine, Javlor and Busilvex Pierre Fabre Global healthcare company Headquartered in France 10,000 employees 37% international Subsidiaries in 43 countries 2014 global sales reached 2.1 billion across 130 countries Allocated 17% of 2014 pharmaceutical sales to R&D including oncology therapy
5 STRATEGIC COLLABORATION WITH PIERRE FABRE ONCOLOGY: SUMMARY OF DEAL TERMS 5 Benefits to Array $30 million upfront 40% funding for certain future clinical development Up to $425 million in potential development & commercialization milestones Robust, tiered double-digit royalties Commercialization Rights Array retains exclusive rights in: United States Canada Japan Korea Israel Pierre Fabre will have exclusive rights in all other geographies, including Europe, Asia & Latin America The agreement remains subject to European Commission on Competition review and approval.
6 BINIMETINIB & ENCORAFENIB PROGRAMS: SIGNIFICANT VALUE TO ARRAY 6 Novartis Responsibility Continues Conducting and/or substantially funding all ongoing trials Providing ongoing product supply and critical transition support for manufacturing Ensuring the NRAS and BRAF melanoma companion diagnostic program is seamlessly transitioned Providing access to several Novartis pipeline agents for combination studies including CDK 4/6 inhibitor and αpi3k inhibitor Joint Future Development with Pierre Fabre Costs split on a 60:40 basis (Array:Pierre Fabre) Initial funding of 100 million+ committed for new clinical trials in colorectal cancer and melanoma Value of Recent Novartis and Pierre Fabre Deals to Array Net cash impact: $137M ($85M Novartis upfront, $30M Pierre Fabre upfront, $22M Novartis extinguished net liabilities) Potential milestones: $425M (from Pierre Fabre) Royalty: Robust, tiered double-digit (from Pierre Fabre Sales) Wholly-Owned Commercial Rights: United States, Canada, Japan, Korea and Israel
7 PATH TO COMMERCIALIZATION: UPCOMING CATALYSTS FOR BINIMETINIB & ENCORAFENIB 7 *Pivotal trial completed patient enrollment or reached target enrollment.
8 Thank You
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