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Array BioPharma Reports Financial Results for the Fourth Quarter and Full Year of Fiscal 2008
Array reported revenue of $6.1 million for the fourth quarter of fiscal 2008, compared to revenue of $8.0 million for the same period in fiscal 2007. The decrease is due to lower collaboration revenue resulting from executing Array's strategy to advance and expand the company's internal proprietary drug discovery programs. Array invested $28.4 million in proprietary research and development for the quarter to help advance its six wholly-owned development programs as well as its portfolio of discovery programs. This compares to $16.1 million during the same quarter last year. Array reported a net loss of $32.4 million, or ($0.68) per share, for the fourth quarter, compared to a net loss of $17.3 million, or ($0.39) per share, for the same quarter in fiscal 2007. Array ended the fourth quarter of fiscal 2008 with $126 million in cash, cash equivalents and marketable securities.
"Fiscal 2008 was a transforming year for Array as we advanced four proprietary drugs into Phase 2 clinical trials and two additional drugs into Phase 1," said Robert E. Conway, Chief Executive Officer, Array BioPharma. "During the next year, we anticipate obtaining clinical proof-of-concept data on several of these drugs, driving us one step closer towards our goal of becoming a fully integrated, commercial-stage biopharmaceutical company."
Fourth Quarter and Subsequent Accomplishments:
Advancing Proprietary Research Programs
-- Presented positive Phase 2 acute inflammatory pain trial results on ARRY-797, a novel pan-cytokine (p38) inhibitor, at the American Pain Society's Annual Scientific Meeting:
-- ARRY-797 achieved its primary and secondary endpoints for analgesic efficacy in a surgical dental pain study. The analgesic effect of ARRY-797 (400 mg), compared to placebo, was statistically significant based upon the primary endpoint of total pain relief over six hours post dose, and total pain relief over all time points up to 24 hours post dose.
-- Pain intensity three hours post surgery was 31.5 mm lower based on a visual analog scale in the group receiving 400 mg of ARRY-797 as compared to placebo. This group also reported faster time to meaningful pain relief and onset of analgesia.
-- Based on these study results, a second Phase 2 acute inflammatory pain trial is underway in 250 patients evaluating three doses of ARRY-797 with both placebo and with an active comparator, celecoxib.
-- Presented Phase 1 clinical trial results in rheumatoid arthritis (RA) patients with ARRY-162, a novel small molecule MEK inhibitor, at the 2008 Annual European Congress of Rheumatology conference. The drug was well tolerated when dosed in combination with methotrexate, had good pharmacokinetic properties and demonstrated 24-hour suppression of inflammatory cytokines, TNF, IL-1 and IL-6, over the course of this 28-day study.
-- Based on the Phase 1 and other data, we initiated a worldwide, 200-patient, 12-week Phase 2 trial with ARRY-162 added to methotrexate in patients with RA.
-- Continued enrolling patients in a Phase 1b expansion trial for ARRY-543, a pan-ErbB inhibitor; 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.
-- Completed patient enrollment in a Phase 1 dose escalation clinical trial of ARRY-520, a small molecule Kinesin Spindle Protein (KSP) inhibitor, and started the expansion phase to further evaluate safety, tolerability and preliminary efficacy at the MTD.
-- Initiated a Phase 1b/2 trial of ARRY-520 in patients with acute myelogenous leukemia.
-- Continued a Phase 1 clinical trial of ARRY-380, an oral, selective ErbB-2 inhibitor for cancer.
-- Continued a Phase 1 clinical trial with ARRY-614, a p38/Tie2 inhibitor. 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.
Partnered Research and Development
-- Genentech exercised its option to extend the discovery collaboration with Array by two years, and agreed to reduce the number of the Array scientists conducting research under the agreement.
-- AstraZeneca presented Phase 1 clinical trial results at the 2008 American Society of Clinical Oncology (ASCO) annual meeting of a new AZD6244 (ARRY-886) capsule formulation that replaces the mix / drink formulation used in all prior trials to date. The new capsule's maximum tolerated dose was 25 percent lower yet provided on average higher exposure than historical values for the mix / drink formulation. The study also reported a complete response in one of the patients.
-- AstraZeneca also presented Phase 2 clinical trial results of AZD6244 at ASCO:
-- In Phase 2 trial results comparing AZD6244 to Alimta(R) (pemetrexed) in 84 non small cell lung cancer (NSCLC) patients, neither of these drugs demonstrated superior efficacy.
-- Phase 2 results showed no difference between the two treatment arms in the overall population comparing AZD6244 to Temodar(R) (temozolomide) in patients with advanced melanoma. The safety and tolerability profile for AZD6244 was found to be consistent with that reported from the Phase 1 trial.
-- Phase 2 results comparing AZD6244 to Xeloda(R) (capecitabine) in patients with metastatic colorectal cancer showed that AZD6244 was generally well tolerated with neither of these drugs demonstrating superior efficacy.
-- AstraZeneca announced two additional Phase 2 trials of AZD6244 at ASCO. Preclinical data suggest that the potential benefit of AZD6244 may be maximized in some tumors when delivered as combination therapy. The two trials will be exploring combinations in advanced melanoma and NSCLC. Patient enrollment will begin during the first quarter of calendar 2009.
Strengthening Financial Position
-- Received a funding commitment of $80 million in debt that is convertible into Array Common Stock from Deerfield Management, a leading healthcare investment organization. The Company received $40 million of this commitment in June 2008 and anticipates receiving the additional $40 million in December 2008.
Revenue for the fiscal year ended June 30, 2008, was $28.8 million, compared to revenue of $37.0 million for fiscal 2007. The net loss for the fiscal year ended June 30, 2008, was $96.3 million, or ($2.04) per share, compared to a net loss of $55.4 million, or ($1.36) per share, reported in fiscal 2007. Array invested $90.3 million in proprietary research and development for the year, compared to $57.5 million for fiscal 2007.
Array will hold a conference call on Tuesday, August 12, 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, August 12, 2008 Time: 9:00 a.m. eastern time Toll-Free: 877-741-4251 Toll: 719-325-4796 Pass Code: 4792834 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 4792834.
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 diseases and pain. 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 timing and scope of our plans to grow our clinical development and commercialization capabilities, the potential to earn future milestone payments, license fees or royalty revenue, the potential for the results of ongoing preclinical and clinical trials to support regulatory approval or the marketing success of a drug candidate, 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 reports filed on form 10-K, our quarterly reports filed on Form 10-Q, 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 and development efforts and to create effective, commercially viable drugs; our ability to effectively and timely conduct clinical trials in light of increasing costs and difficulties in locating appropriate trial sites and in enrolling patients who meet the criteria for certain clinical trials; risks associated with our dependence on third party service providers to successfully conduct clinical trials within and outside the United States; 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 BioPharma Inc. to meet objectives tied to milestones and royalties; our ability to attract and retain experienced scientists; and management. We are providing this information as of August 11, 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 Fiscal Years Ended June 30, June 30, ------------------- ------------------- 2008 2007 2008 2007 --------- --------- --------- --------- Revenue: Collaboration revenue $4,645 $6,758 $21,513 $30,106 License and milestone revenue 1,441 1,248 7,295 6,864 --------- --------- --------- --------- Total revenue 6,086 8,006 28,808 36,970 Operating expenses (a) Cost of revenue (1) 5,086 6,287 21,364 24,936 Research and development for proprietary drug discovery (2) 28,350 16,088 90,347 57,464 General and administrative (3) 2,647 4,122 15,591 13,644 --------- --------- --------- --------- Total operating expenses 36,083 26,497 127,302 96,044 --------- --------- --------- --------- Loss from operations (29,997) (18,491) (98,494) (59,074) Impairment of marketable securities (1,872) - (1,872) - Interest income 783 1,487 6,064 4,611 Interest expense (1,351) (246) (1,986) (979) --------- --------- --------- --------- Net loss $(32,437) $(17,250) $(96,288) $(55,442) ========= ========= ========= ========= Basic and diluted net loss per share $(0.68) $(0.39) $(2.04) $(1.36) ========= ========= ========= ========= Number of shares used to compute per share data 47,529 44,283 47,309 40,717 ========= ========= ========= ========= (a)Includes stock-based compensation expense (1) Cost of revenue $281 $301 $1,259 $1,127 (2) Research and development for proprietary drug discovery 889 583 3,295 1,748 (3) Selling, general and administrative expenses 370 461 1,605 1,936 --------- --------- --------- --------- Total $1,540 $1,345 $6,159 $4,811 ========= ========= ========= =========
Summary Balance Sheet Data (in thousands) June 30, June 30, 2008 2007 ---------- --------- Cash, cash equivalents and marketable securities $125,531 $141,331 Property, plant and equipment, gross 80,878 72,964 Working capital 66,346 120,829 Total assets 163,077 174,974 Long-term debt 35,355 15,000 Stockholders' equity 38,027 107,703
SOURCE: Array BioPharma Inc.
Array BioPharma Inc.
Tricia Haugeto, 303-386-1193