News

Printer Friendly Version View printer-friendly version
<< Back
Array BioPharma Reports Financial Results for the Fourth Quarter and Full Year of Fiscal 2009

BOULDER, Colo.--(BUSINESS WIRE)--Aug. 10, 2009-- Array BioPharma Inc. (NASDAQ: ARRY) today reported financial results for the fourth quarter and full year of fiscal 2009.

Array reported revenue of $5.5 million for the fourth quarter of fiscal 2009, compared to revenue of $6.1 million for the same period in fiscal 2008. Array invested $21.3 million in proprietary research and development for the quarter to advance its seven wholly-owned drugs in clinical development and select discovery programs. This compares to $28.4 million invested in research and development during the fourth quarter of fiscal 2008. Array reported a net loss of $26.7 million, or ($0.55) per share, for the fourth quarter, compared to a net loss of $32.4 million, or ($0.68) per share, for the fourth quarter in fiscal 2008. Array ended the fourth quarter of fiscal 2009 with $57.5 million in cash, cash equivalents and marketable securities. In addition, Array received $40.0 million in capital from Deerfield Private Design Fund, L.P. and Deerfield Private Design International, L.P. (collectively the “Deerfield Funds”) on August 5, 2009 under a loan facility agreement dated May 15, 2009.

Array reported revenue of $25.0 million for the fiscal year ended June 30, 2009, compared to revenue of $28.8 million for fiscal 2008. Net loss for the fiscal year ended June 30, 2009, was $127.8 million, or ($2.67) per share, compared to a net loss of $96.3 million, or ($2.04) per share, reported in fiscal 2008. Array invested $89.6 million in proprietary research and development for the year, compared to $90.3 million for fiscal 2008.

“We are pleased to report positive results from our Phase 1 clinical trial of ARRY-403 in patients with Type 2 diabetes,” said Robert E. Conway, Chief Executive Officer. “There are 24 million Type 2 diabetic patients in the U.S. with the incidence of the disease accelerating at an alarming rate. Many of these patients are unable to control their glucose levels with existing therapy and need better approaches to manage their disease. ARRY-403 provides a unique mechanism of action for controlling diabetes with the potential to address this critical unmet medical need. We have initiated an aggressive development program, while also seeking a partner to maximize ARRY-403’s benefit to patients.”

SUMMARY OF RECENT PROGRESS
Clinical trial completed in Type 2 diabetic patients:
ARRY-403GK activator for Type 2 diabetes: Array announced positive top-line data from a Phase 1 clinical trial in patients with Type 2 diabetes with its novel small molecule glucokinase activator (GKA), ARRY-403. The drug met its primary and secondary endpoints of safety, pharmacokinetics and glucose control. Additional data is available from Array BioPharma’s website at www.arraybiopharma.com

Six clinical programs advanced for the treatment of cancer:
ARRY-162 – MEK inhibitor for cancer: Array filed an investigational new drug application with the FDA and is now able to proceed with a Phase 1 clinical trial in cancer patients with its most advanced wholly-owned MEK inhibitor, ARRY-162. Recent publications have shown that the MEK pathway acts as a central axis in the proliferation of different tumors including melanoma, non-small cell lung, colorectal and pancreatic cancers. The Phase 1 dose escalation study is designed to evaluate safety, pharmacokinetics and pharmacodynamics of ARRY-162 following daily oral administration to patients with advanced solid tumors.

ARRY-520 – KSP inhibitor for AML & 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, respectively.

ARRY-614 - p38/Tie-2 Inhibitor for MDS: In March 2009, Array reported data from a Phase 1 clinical trial with ARRY-614 in a single and multiple dose-escalation study in healthy subjects. This study showed that ARRY-614 was well tolerated and exhibited dose-dependent increases in exposure and strong evidence of pharmacodynamic activity. Based on this data and strong biological support for testing a p38 inhibitor in myelodysplastic syndromes (MDS), Array is dosing patients with MDS 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 completed enrollment in a Phase 1b trial with ARRY-543 in patients with ErbB2+ metastatic breast cancer and other ErbB-expressing tumors. Array continued a Phase 1 dose-escalation study with tablet formulation in patients with solid tumors and a Phase 1b trial in combination with Xeloda® (capecitabine) in patients with solid tumors. Array initiated dosing patients in two additional Phase 1b trials, in combination with Taxotere® (docetaxel) and Gemzar® (gemcitabine).

ARRY-380 - ErbB2 selective inhibitor for cancer: Patient recruitment in a Phase 1 trial with ARRY-380, an oral, selective ErbB2 (Her2) inhibitor, remains on track to complete enrollment this year. The trial is designed to evaluate the safety and pharmacokinetics of ARRY-380 in patients with advanced cancer and to establish the maximum tolerated dose.

ARRY-300 – MEK inhibitor: Array completed enrollment in a Phase 1 trial with ARRY-300, a targeted small molecule MEK inhibitor. The Phase 1 trial was a randomized, single-blind, placebo-controlled, single-ascending dose study to evaluate the safety, pharmacokinetics and pharmacodynamics of ARRY-300 in healthy volunteers. ARRY-300 will be a back-up for ARRY-162.

Two clinical program updates for the treatment of chronic inflammatory disease and pain:
ARRY-162 - MEK inhibitor for RA: Array completed a 12 week Phase 2, randomized, double-blind, placebo controlled global proof-of-concept trial with ARRY 162 in patients with active RA who were receiving stable doses of methotrexate for ≥ 6 weeks. Top-line results are expected to be available in September 2009.

ARRY-797 - p38 inhibitor for AS: Array announced top-line results from its Phase 1, seven-day, dose escalation trial up to 1,200 mg daily of ARRY-797 in healthy volunteers. In addition, the top-line results were announced in a second study, where ARRY-797 was evaluated in a 28-day Phase 1b trial in stable RA patients taking methotrexate. A preliminary analysis of both trials indicates that ARRY-797 was well-tolerated with a pharmacokinetic profile consistent with earlier studies. In the 28-day, three-arm RA study with a total of 28 patients, ARRY-797 showed inhibition of CRP levels (marker of inflammation) only during the first three weeks of dosing and a beneficial reduction in NTx levels (marker of bone remodeling) throughout the study. In addition, ARRY-797 showed a trend to improve the patients’ assessment of pain (VAS score) over the course of the study.

Array continues to conduct a full analysis of safety, pharmacokinetics and efficacy data from both studies and anticipates that complete results from the studies will be presented at a medical conference in 2010. Based on these preliminary results, Array has discontinued the enrollment of new patients in its clinical trial of ARRY-797 in ankylosing spondylitis. Array is evaluating alternative development paths in sub-chronic pain and supportive care indications.

Array’s Information Technology Platform recognized by CIO magazine: IDG's CIO magazine announced Array as a recipient of the 2009 CIO 100. The 22nd annual award program recognizes organizations around the world that exemplify the highest level of operational and strategic excellence in information technology.

Array received additional capital: Array received $40.0 million in additional capital from the Deerfield Funds on August 5, 2009 under a loan facility agreement dated May 15, 2009. The outstanding principal under the new loan is due by April 2014 and interest is payable monthly. Principal and interest can be repaid, at Array’s option, at any time with shares of Array common stock.

Array will hold a conference call on Tuesday, August 11, 2009, 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 11, 2009

Time:

9:00 a.m. eastern time

Toll-Free:

888-726-2459

Toll:

913-312-0977

Pass Code:

6778402

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 6778402.

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.

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 August 10, 2009. 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
(Unaudited)
(in thousands, except per share amounts)
     
Three Months Ended June 30, Year Ended June 30,
2009 2008 2009   2008
 
Revenue
Collaboration revenue $ 3,801 $ 4,645 $ 17,228 $ 21,513
License and milestone revenue 1,706   1,441   7,754   7,295  
Total revenue 5,507 6,086 24,982 28,808
 
Operating expenses
Cost of revenue 4,157 5,086 19,855 21,364

Research and development for proprietary
 drug discovery

21,313 28,350

89,560

90,347
General and administrative 4,587   2,647   18,020   15,591  
Total operating expenses 30,057   36,083   127,435   127,302  
 
Loss from operations (24,550 ) (29,997 ) (102,453 ) (98,494 )
 
Other income (expense)
Impairment of marketable securities - (1,872 ) (17,742 ) (1,872 )
Interest income 296 783 2,116 6,064
Interest expense (2,736 ) (1,351 ) (10,024 ) (1,986 )
Total other income (2,440 ) (2,440 ) (25,650 ) 2,206  
 
Loss before income tax benefit (26,990 ) (32,437 ) (128,103 ) (96,288 )
 
Income tax benefit 288   -   288   -  
 
Net loss $ (26,702 ) $ (32,437 ) $ (127,815 ) $ (96,288 )
 
Weighted average shares outstanding -
basic and diluted 48,119   47,529   47,839   47,309  
 
Net loss per share - basic and diluted $ (0.55 ) $ (0.68 ) $ (2.67 ) $ (2.04 )
Summary Balance Sheet Data
(in thousands)
 
          June 30,   June 30,
2009 2008
 
Cash, cash equivalents and marketable securities $ 57,488 $ 125,531
Property, plant and equipment, gross $ 83,683 $ 80,878
Working capital $ (5,378 ) $ 66,346
Total assets $ 95,055 $ 163,077
Long-term debt, net $ 68,170 $ 35,355
Stockholders' equity $ (73,701 ) $ 38,027

Source: Array BioPharma Inc.

Array BioPharma Inc.
Tricia Haugeto, 303-386-1193
thaugeto@arraybiopharma.com