|View printer-friendly version|
|Array BioPharma Reports Financial Results for the First Quarter of Fiscal 2009|
BOULDER, Colo.--(BUSINESS WIRE)--Nov. 3, 2008--Array BioPharma Inc. (NASDAQ: ARRY) today reported financial results for the first quarter of fiscal 2009.
Array reported revenue of $5.7 million for the first quarter of fiscal 2009, compared to revenue of $6.6 million for the same period in fiscal 2008. Array invested $24.5 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 $17.6 million during the same quarter last year. Array reported a net loss of $33.7 million, or ($0.71) per share, for the first quarter, which included $0.08 per share loss due to a mark-to-market write down of auction rate securities. This compares to a net loss of $19.1 million, or ($0.40) per share, for the same quarter in fiscal 2008. Array ended the first quarter of fiscal 2009 with $100.6 million in cash, cash equivalents and marketable securities. Array will draw the second tranche of the Deerfield credit facility of $40 million in December 2008.
"ARRY-403, our glucokinase activator for type 2 diabetes, has successfully completed regulated safety testing and we plan to initiate a clinical trial next quarter," said Robert E. Conway, Chief Executive Officer, Array BioPharma. "By the end of calendar 2009, we anticipate obtaining proof-of-concept data on four additional clinical trials. Positive results on any of these trials will add significant value to Array and potential partners."
First Quarter and Subsequent Accomplishments: Advancing Proprietary Research Programs -- ARRY-797, p38 inhibitor -- Announced positive results from a Phase 2 acute inflammatory dental pain study evaluating the analgesic efficacy of ARRY-797 at the 2008 ACR/ARHP Annual Scientific Meeting. -- This Phase 2 randomized study enrolled 253 patients with postsurgical pain. Three doses of ARRY-797 (200 mg, 400 mg and 600 mg) were compared to placebo and celecoxib (400 mg). In the primary efficacy measure of total pain relief over six hours post dose (p less than 0.001), ARRY-797 produced a dose-dependent analgesic response, compared to placebo. ARRY-797 (400 and 600 mg) and celecoxib (400 mg) demonstrated significant analgesic benefit, robust pain relief, and good duration of analgesia. -- Also at the conference, Array presented results from two previous ARRY-797 trials. In the first Phase 2 dental pain study, CRP levels, a biomarker of systemic inflammation and cardiovascular disease, were measured. Compared to placebo, ARRY-797 reduced CRP by 85% on the day following surgery. In a Phase 1 study, ARRY-797 significantly inhibited the inflammatory cytokines TNF and IL-1 and the pain mediator PGE2 out to 24 hours post-dose. -- To view all scientific posters presented at ACR/ARHP go to: http://www.arraybiopharma.com/PatentsPublications/ Default.asp?PBCategoryID=3 (Due to its length, this URL may need to be copied/pasted into your Internet browser's address field. Remove the extra space if one exists.) -- Continued ARRY-797 in a 28-day Phase 1b trial in rheumatoid arthritis patients on stable doses of methotrexate. -- ARRY-162, MEK inhibitor for inflammation -- Continued a worldwide, 200-patient, 12-week Phase 2 trial with ARRY-162 added to methotrexate in patients with rheumatoid arthritis. -- ARRY-403, glucokinase activator for metabolic disease -- Nominated ARRY-403 as a clinical candidate and completed regulated safety assessment testing. We anticipate initiating a Phase 1 clinical trial in the first quarter of 2009. -- ARRY-614, p38 / Tie2 inhibitor -- Completed enrollment of a Phase 1 clinical trial with ARRY-614. The compound is being evaluated in a single and multiple dose escalation study in healthy volunteers for safety, tolerability, exposure and inhibition of mechanism-related biomarkers. -- ARRY-543, ErbB-2 / EGFR inhibitor -- Continued a Phase 1b expansion trial for ARRY-543; half of the patients have trastuzumab-resistant ErbB2-positive metastatic breast cancer and half of the patients have other ErbB-family-driven cancers. -- Continued a Phase 1b/2 trial of ARRY-543 in combination with Xeloda (capecitabine). -- ARRY-520, KSP inhibitor -- Continued a Phase 1 expansion trial of ARRY-520 to evaluate the safety, tolerability and preliminary efficacy at the maximum tolerated dose. -- Continued a Phase 1b/2 trial of ARRY-520 in patients with acute myelogenous leukemia. -- ARRY-380, ErbB-2 inhibitor -- Continued a Phase 1 clinical trial of ARRY-380. Partnered Research -- Genentech added a new program and extended through 2011 our discovery collaboration. This new program provides for a one-time license fee, research funding, and potential milestone and royalty payments. Array and Genentech are currently working on a total of five programs in research and development.
Array will hold a conference call on Tuesday, November 4, 2008, 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 4, 2008 Time: 9:00 a.m. Eastern time Toll-Free: 877-719-9810 Toll: 719-325-4808 Pass Code: 1160404 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 1160404.
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, inflammatory and metabolic diseases. Our proprietary drug development pipeline includes clinical candidates that are designed to regulate therapeutically important target proteins and are aimed at significant unmet medical needs. 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, 2008, 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 3, 2008. 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, --------------------------- 2008 2007 ------------- ------------- Revenue: Collaboration revenue $4,238 $5,621 License and milestone revenue 1,510 972 ------------- ------------- Total revenue 5,748 6,593 Operating expenses Cost of revenue 5,120 5,313 Research and development for proprietary drug discovery 24,509 17,619 General and administrative 4,492 4,377 ------------- ------------- Total operating expenses 34,121 27,309 ------------- ------------- Loss from operations (28,373) (20,716) Impairment of marketable securities (3,910) - Interest income 878 1,907 Interest expense (2,280) (245) ------------- ------------- Net loss $(33,685) $(19,054) ============= ============= Basic and diluted net loss per share $(0.71) $(0.40) ============= ============= Number of shares used to compute per share data 47,573 47,109 ============= ============= Summary Balance Sheet Data (in thousands) September 30, June 30, 2008 2008 ------------- ------------- Cash, cash equivalents and marketable securities $100,589 $125,531 Property, plant and equipment, gross 81,966 80,879 Working capital 39,403 66,346 Total assets 137,369 163,077 Long-term debt 37,063 35,355 Stockholders' equity 8,046 38,027
CONTACT: Array BioPharma Inc.