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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
        -- 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:
           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
-- 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
-- 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:

A replay of the call will be available as a webcast on 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

Forward-Looking Statement

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)

                                               Three Months Ended
                                                  September 30,
                                               2008          2007
                                           ------------- -------------

  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.
Tricia Haugeto, 303-386-1193

SOURCE: Array BioPharma Inc.

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