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|Array BioPharma Reports Financial Results for the First Quarter of Fiscal 2008|
BOULDER, Colo.--(BUSINESS WIRE)--Nov. 5, 2007--Array BioPharma Inc. (NASDAQ: ARRY) today reported financial results for the first quarter of fiscal 2008.
Array reported revenue of $6.6 million for the first quarter of fiscal 2008, compared to revenue of $11.0 million for the same period in fiscal 2007. Array invested $17.6 million in research and development for the quarter to advance its eight wholly-owned development programs as well as its portfolio of discovery programs. This compares to $10.9 million during the same quarter last year. Array reported a net loss of $19.1 million, or ($0.40) per share, for the first quarter, compared to a net loss of $8.2 million, or ($0.21) per share, for the same quarter in fiscal 2007. Array ended the first quarter of fiscal 2008 with $168.2 million in cash, cash equivalents and marketable securities.
"We are pleased that ARRY-543, our ErbB-2 / EGFR inhibitor, produced stable disease in patients with advanced solid tumors in a Phase 1 clinical trial, as presented at the 2007 AACR-NCI-EORTC conference and, as a result, we are advancing the drug into three Phase 1b/2 trials," said Robert E. Conway, Chief Executive Officer, Array BioPharma. "Also during the quarter, we announced the largest deal in our history with Celgene to discover, develop and commercialize targeted therapies to treat cancer and inflammation."
First Quarter and Subsequent Accomplishments: Advancing Proprietary Research Programs -- Presented Phase 1 data on ARRY-543, an ErbB-2 and EGFR dual inhibitor, at the 2007 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. ARRY-543 produced stable disease in refractory patients with advanced solid tumors in the Phase 1 trial. ARRY-543 was well-tolerated up to 300 mg BID (twice daily). Systemic concentrations of ARRY-543 increased with escalating doses at all dose levels tested. In completed cohorts, sixty percent of patients receiving doses of 200 mg BID and higher had prolonged stable disease. Based on these results, the BID regimen has been chosen for Phase 2 studies. -- Planned to begin Phase 1b / 2 clinical trials for ARRY-543 over the next 12 months including: -- Expansion of the Phase 1 trial in 30 to 40 additional patients at the maximum tolerated dose (MTD); half of the patients will have trastuzumab-resistant ErbB2-positive metastatic breast cancer and half of the patients will have other ErbB-family-driven cancers; -- A Phase 1b/2 trial of ARRY-543 in combination with cetuximab in patients with metastatic colorectal cancer; -- A Phase 1b/2 trial of ARRY-543 in combination with capecitabine in patients with metastatic breast cancer; and -- A Phase 1b/2 trial of ARRY-543 in combination with trastuzumab as maintenance therapy for patients with metastatic breast cancer
-- Neared completion of a Phase 1b trial with ARRY-162 added to methotrexate in patients with stable rheumatoid arthritis (RA). Array plans to begin a Phase 2 trial with ARRY-162 in RA patients in early 2008. ARRY-162 is likely to be the first MEK inhibitor to enter Phase 2 studies for the treatment of inflammatory disease. -- Advanced ARRY-797, a novel p38 inhibitor, in a Phase 1 multiple ascending dose (MAD) clinical trial in healthy volunteers, which is nearing completion. Array is initiating a Phase 2 trial with ARRY-797 to treat patients with post-operative dental pain. -- Advanced ARRY-520, a small molecule Kinesin Spindle Protein (KSP) inhibitor, in a Phase 1 dose escalation clinical trial in cancer patients. ARRY-520 caused marked tumor regression in preclinical models of human solid tumors and human leukemias. -- Advanced ARRY-380, an oral, selective ErbB-2 inhibitor for cancer, in a Phase 1 clinical trial. -- Completed regulated safety assessment testing on ARRY-614, a p38 / Tie2 inhibitor. Array is preparing an IND application and plans to file it within the next three months. -- Continued ARRY-886 (AZD6244), a novel MEK inhibitor, in Phase 2 clinical development for the treatment of metastatic melanoma, colorectal, pancreatic and non-small cell lung cancers. These trials are being conducted by our partner AstraZeneca PLC. -- Advanced ARRY-704 (AZD8330), a novel MEK inhibitor being developed by AstraZeneca, into a Phase 1 clinical trial in cancer patients. Partnered Research -- Announced a worldwide strategic collaboration with Celgene Corporation focused on the discovery, development and commercialization of novel therapeutics in cancer and inflammation.
-- Array granted Celgene an option to license worldwide rights to drugs developed under the collaboration that are directed to two of the four mutually selected discovery targets. -- Array will be responsible for all discovery and clinical development through Phase 1 or Phase 2a. For the programs selected by Celgene, Celgene will be responsible for later-stage clinical development and commercialization, except for Array's co-promotion rights in the U.S. -- Under the agreement, Celgene made an upfront payment of $40 million to Array and Array is entitled to receive, for each drug licensed to Celgene, potential milestone payments of approximately $200 million, if certain discovery, development and regulatory milestones are achieved and $300 million if certain commercial milestones are achieved, as well as royalties on net sales. Array will retain all rights to the other programs
Enhancing Leadership -- Appointed Markus Herzig to the newly created position of Vice President, Regulatory Affairs & Clinical Quality Assurance. Mr. Herzig will oversee the Regulatory and Clinical Quality Assurance activities of Array's growing cancer and inflammation pipeline.
Array will hold a conference call on Tuesday, November 6, 2007, at 9:00 a.m. Eastern time to discuss these results. Robert E. Conway, Chief Executive Officer, and Michael Carruthers, Chief Financial Officer, will lead the call.
Conference Call Information Date: Tuesday, November 6, 2007 Time: 9:00 a.m. Eastern time Toll-Free: 877-795-3646 Toll: 719-325-4821 Pass Code: 8474459 Web Cast: www.arraybiopharma.com
A replay of the call will be available as a webcast on www.arraybiopharma.com and by phone for one week by dialing toll-free 888-203-1112 or 719-457-0820. The access code is 8474459.
About Array BioPharma
Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule drugs to treat patients afflicted with cancer and inflammatory diseases. Our proprietary drug development pipeline includes clinical candidates that are designed to regulate therapeutically important target proteins and are aimed at large market opportunities. In addition, leading pharmaceutical and biotechnology companies collaborate with Array to discover and develop drug candidates across a broad range of therapeutic areas. For more information on Array, please go to www.arraybiopharma.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about our future plans for advancing certain of our proprietary drug programs, the potential to earn future milestone payments, license fees or royalty revenue, and the plans of our collaborators to further develop drugs we have out-licensed or on which we are collaborating. These statements involve significant risks and uncertainties, including those discussed in our annual report filed on form 10-K for the year ended June 30, 2007, and in other reports filed by Array with the Securities and Exchange Commission. Because these statements reflect our current expectations concerning future events, our actual results could differ materially from those anticipated in these forward-looking statements as a result of many factors. These factors include, but are not limited to, our ability to continue to fund and successfully progress internal research efforts and to create effective, commercially viable drugs, our ability to achieve and maintain profitability, the extent to which the pharmaceutical and biotechnology industries are willing to in-license drug candidates for their product pipelines and to collaborate with and fund third parties on their drug discovery activities, our ability to out-license our proprietary candidates on favorable terms, risks associated with our dependence on our collaborators for the clinical development and commercialization of our out-licensed drug candidates, the ability of our collaborators and of Array to meet objectives tied to milestones and royalties, and our ability to attract and retain experienced scientists and management. We are providing this information as of November 5, 2007. We undertake no duty to update any forward-looking statements to reflect the occurrence of events or circumstances after the date of such statements or of anticipated or unanticipated events that alter any assumptions underlying such statements.
Array BioPharma Inc. Condensed Statements of Operations (in thousands, except per share amounts) (Unaudited) Three Months Ended September 30, --------------------------- 2007 2006 ------------- ------------- Revenue: Collaboration revenue $5,621 $7,989 License and milestone revenue 972 3,037 ------------- ------------- Total revenue 6,593 11,026 Operating expenses (a) Cost of revenue (1) 5,313 6,267 Research and development for proprietary drug discovery (2) 17,619 10,853 General and administrative expenses (3) 4,377 2,969 ------------- ------------- Total operating expenses 27,309 20,089 ------------- ------------- Loss from operations (20,716) (9,063) Interest income 1,907 1,072 Interest expense (245) (240) ------------- ------------- Net loss $(19,054) $(8,231) ============= ============= Basic and diluted net loss per share $(0.40) $(0.21) ============= ============= Number of shares used to compute per share data 47,109 39,148 ============= ============= (a) Includes stock-based compensation expense (1) Cost of revenue $305 $329 (2) Research and development for proprietary drug discovery 648 370 (3) General and administrative expenses 429 503 ------------- ------------- Total $1,382 $1,202 ============= ============= Summary Balance Sheet Data (in thousands) September 30, June 30, 2007 2007 ------------- ------------- Cash, cash equivalents and marketable securities $168,166 $141,331 Working capital 137,297 120,829 Total assets 202,279 174,974 Long term debt 15,000 15,000 Stockholders' equity 90,492 107,703
CONTACT: Array BioPharma Inc.