Array BioPharma Inc. (Nasdaq: ARRY) today reported financial results for the third quarter of fiscal 2010.
“Our recent deals with Novartis and Amgen provide Array with $105 million in initial payments, over $1 billion in potential milestone payments, double digit royalties and commercial co-detailing rights”
Array reported increased revenue of $18.4 million for the third quarter of fiscal 2010, compared to revenue of $6.0 million for the same period in fiscal 2009. Array spent $17.7 million for proprietary research and development during the quarter to advance its wholly-owned drugs in clinical development and discovery programs. This compares to $20.0 million spent for research and development during the third quarter of fiscal 2009. Array's net loss improved to $15.2 million, or ($0.30) per share, for the third quarter, compared to a net loss of $29.6 million, or ($0.62) per share, for the third quarter in fiscal 2009. Array ended the third quarter of fiscal 2010 with $100.3 million in cash, cash equivalents and marketable securities. The March 31, 2010 cash balance does not include initial payments totaling $45 million from Novartis International Pharmaceutical Ltd. to be paid during Array's fourth quarter under a License Agreement signed by Array and Novartis after March 31, 2010.
Array reported revenue of $35.9 million for the nine-month period ended March 31, 2010, compared to revenue of $19.5 million for the same period in fiscal 2009. Net loss for the nine months ended March 31, 2010, was $61.8 million, or ($1.25) per share, compared to a net loss of $101.1 million, or ($2.12) per share, reported in the same nine-month period in fiscal 2009.
"Our recent deals with Novartis and Amgen provide Array with $105 million in initial payments, over $1 billion in potential milestone payments, double digit royalties and commercial co-detailing rights," said Robert E. Conway, Chief Executive Officer. "We now have eight partnered drugs in clinical development and three significant discovery collaborations, with potential upside of $2.5 billion in milestone payments and royalties that reach double digits. Based on our current assumptions, our analysis of the estimated risk-adjusted net present value of this potential income from our partnered drugs alone significantly exceeds the current market capitalization of the Company. This is in addition to what we believe is our most valuable asset: our exciting pipeline of 100% Array-owned drugs."
SUMMARY OF RECENT PROGRESS
Array partners with Novartis in cancer - MEK162 (ARRY-162) - MEK inhibitor:
- Array partnered with Novartis for the worldwide development of the small-molecule MEK inhibitors MEK162 (ARRY-162), currently in a Phase 1 cancer trial, its back-up, MEK300 (ARRY-300), and other MEK inhibitors. Array will initially receive $45 million in the fourth quarter ending June 30, 2010, comprising an upfront and milestone payment, and is eligible to receive an additional $422 million if certain clinical, regulatory and commercial milestones are achieved. In addition, Array plans to co-develop MEK162 in one or more specific indications and fund a portion of development costs. The agreement provides Array with double-digit royalties on sales of approved drugs outside of the U.S., with a significantly higher royalty rate for U.S. sales provided that Array meets its co-funding obligations. Array also has a co-detailing right in the U.S. for approved drugs.
- Array will continue to advance MEK162 into an expansion phase of a Phase 1 trial at the maximum tolerated dose in biliary tract cancer patients at ten clinical sites in North America. The expansion study is designed to evaluate safety, pharmacokinetics and pharmacodynamics of MEK162 in patients with biliary tract cancer.
Partnerships advance with Amgen, Genentech, Celgene and InterMune:
Amgen collaboration AMG 151 / ARRY-403 - GK activator for type 2 diabetes: Array continued a Phase 1 multiple ascending dose clinical trial in patients with type 2 diabetes, with AMG 151 / ARRY-403, a small-molecule glucokinase activator that Array partnered with Amgen Inc. in December 2009. Array also continued a research program, which is being funded by Amgen, to identify and advance second-generation glucokinase activators.
Genentech collaboration: Array received $3.75 million from Genentech during Array's third quarter for achieving milestones on two undisclosed programs.
Celgene Research Programs - c-fms, TYK2, PDGFR: Celgene announced for the first time progress on three Array-partnered research programs during their research and development event on April 8, 2010: c-fms (oncology), TYK2 (inflammation) and PDGFR (inflammation). Celgene reported that all three programs have the possibility of entering clinical development over the next 12 to 24 months. Under the terms of Array's agreement with Celgene, Celgene has the option to select two of the programs and Array would retain rights to the third program.
InterMune announces positive danoprevir (RG7227 and ITMN-191) results:
InterMune, Inc. announced top-line results from a planned week 12 interim analysis of the Phase 2b randomized, partially-blind study evaluating the hepatitis C virus protease inhibitor danoprevir, also known as RG7227 / ITMN-191, which was coinvented by Array and InterMune. Danoprevir was administered for 12 weeks in combination with PEGASYS® (pegylated interferon alfa-2a) and COPEGUS® (ribavirin), compared with placebo for the same duration plus PEGASYS and COPEGUS. InterMune reported that results from the 12-week study indicate danoprevir plus PEGASYS and COPEGUS are capable of achieving complete Early Virologic Response rates as high at 90 percent.
Array advances four clinical programs for the treatment of cancer:
ARRY-520 - KSP inhibitor for AML and MM: Array continued a Phase 1 trial of ARRY-520, a novel KSP inhibitor, in patients with solid tumors and two Phase 1/2 trials in patients with acute myelogenous leukemia and multiple myeloma.
ARRY-614 - p38/Tie-2 Inhibitor for MDS: Array continued dosing patients with myelodysplastic syndrome in a Phase 1 trial with ARRY-614 to determine the safety, maximum tolerated dose, pharmacokinetics and preliminary estimates of efficacy of the compound in this patient population.
ARRY-543 - ErbB family inhibitor for solid tumors: Array achieved the maximum tolerated dose of ARRY-543 in three Phase 1b trials of ARRY-543 in combination with Xeloda® (capecitabine), Taxotere® (docetaxel) and Gemzar® (gemcitabine), respectively. Trial results will be disclosed at an appropriate scientific conference over the next year.
ARRY-380 - HER2 oral, selective inhibitor for cancer: Array continued dose escalation in a Phase 1 trial to evaluate the safety, maximum tolerated dose and pharmacokinetics of ARRY-380 in patients with advanced cancer.