SOUTH SAN FRANCISCO, Calif., Nov. 15, 2010 /PRNewswire-FirstCall/ -- diaDexus, Inc. (OTC Bulletin Board: DDXS), a diagnostics company focused on the development and commercialization of patent-protected in vitro diagnostic products addressing unmet needs in cardiovascular disease, today announced financial results for the third quarter of 2010. Total revenues for the 2010 third quarter at $3.2 million represented a 26% growth over total revenues of $2.5 million for the third quarter of 2009. Net cash used in operating activities for the third quarter of 2010 was $2.2 million.
Year-to-date revenues for the period ended September 30, 2010 were $8.5 million vs. $8.8 million in the same period a year ago, a decrease primarily attributable to lower product sales due to a related party's reduced clinical trials testing. Revenues were also impacted by the previously disclosed voluntary withdrawal of the PLAC TIA Test in May 2010, one of the two formats of the PLAC Test. Cash and short term investments at September 30, 2010 were $23.2 million compared to $4.8 million at December 31, 2009. The increase is primarily a result of the reverse merger transaction with VaxGen, Inc. completed July 28, 2010, from which diaDexus obtained $23.4 million in cash and equivalents held by VaxGen, partially offset by the repayment of debt and cash used in operating activities.
Commenting on the financial results, Chief Executive Officer Patrick Plewman stated, "We are pleased to report good growth despite the lower related party sales and the voluntary withdrawal of the PLAC TIA product. We believe we have addressed the root cause of the PLAC TIA product performance issue, and a new 510(k) for an enhanced PLAC TIA product was submitted to the FDA on June 30, 2010." Mr. Plewman also commented, "The PLAC test provides valuable information, over and above traditional risk factors, such as smoking, blood pressure, cholesterol, family history and age, to help identify individuals at increased risk of suffering a heart attack or stroke."
diaDexus said it believes that total revenues for 2010 will be approximately $11.2-11.4 million vs. $11.9 million in 2009, a decrease primarily attributable to lower product sales to a related party and the voluntary withdrawal of the PLAC TIA product. diaDexus also provided guidance for 2011, projecting approximately a 10 percent increase in year-over-year total revenues, or $12-13 million for 2011. For the fourth quarter of 2010, the company expects cash used in operations to be approximately $3-3.5 million, reflecting three months of post-reverse merger operating expenses, in contrast to the third quarter of 2010, in which only two months of expenses were included. The company also projected that it has sufficient cash through 2011, based on its current operating plan. Future financing needs will depend on the company's ability to maintain and grow its current product revenues, progress in achieving additional positive coverage decisions from insurers for the PLAC test, the timing of the FDA clearance of the enhanced PLAC TIA product, and the company's ability to manage its obligations under real estate leases and obligations to employees.
diaDexus said it is hosting a webcast on Tuesday, November 16 at 1:30 PM EST (10:30 AM PST) to present a corporate overview and further discuss the 2010 third quarter's financial results as well as its guidance for both the year-end and 2011. The webcast may be accessed via the company's website at www.diadexus.com/webcast.
About diaDexus, Inc.
diaDexus, Inc., based in South San Francisco, California, is focused on the development and commercialization of patent-protected in vitro diagnostic products addressing unmet needs in cardiovascular disease. The company's PLAC ELISA Test for Lp-PLA2 is the only blood test cleared by the FDA to aid in assessing risk for both coronary heart disease and ischemic stroke associated with atherosclerosis. For more information, please visit the company's website at www.diaDexus.com
Forward-Looking StatementsThis news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the company's plans, objectives, expectations and intentions with respect to future operations and products and other statements that are not historical in nature, particularly those that use terminology such as "will," "potential", "could," "can," "believe," "intends," "continue," "plans," "expects," "projects," "estimates" or comparable terminology. Forward-looking statements are based on current expectations and assumptions, and entail various known and unknown risks and uncertainties that could cause actual results to differ materially from those expressed in such forward-looking statements. Important factors known to diaDexus that could cause actual results to differ materially from those expressed in such forward-looking statements include diaDexus' ability to identify the root cause of product performance issues and to obtain and maintain regulatory clearance for our PLAC Test and new diagnostic products, including receiving approval to reintroduce our PLAC TIA product, shipments of which we suspended in May 2010; diaDexus' ability to demonstrate that treatment of individuals based on their Lp-PLA2 levels improves clinical outcomes in prospective clinical studies; the rate of adoption of the PLAC Test by doctors and laboratories; the insurance payer community's acceptance of and reimbursement for the PLAC Test; diaDexus' reliance on sole source third party manufacturers to manufacture and supply our main reagent and the PLAC Test; our ability to retain key employees and to attract, retain and motivate other qualified personnel; diaDexus' limited revenue and cash resources; and diaDexus' significant corporate expenses, including expenses associated with being a public company. Additional factors that could cause diaDexus' results to differ materially from those described in the forward-looking statements can be found in diaDexus' most recent quarterly report on Form 10-Q and other reports filed with the Securities and Exchange Commission, and available at the SEC's web site at www.sec.gov. The information set forth herein speaks only as of the date hereof, and diaDexus disclaims any intention and does not assume any obligation to update or revise any forward looking statement, whether as a result of new information, future events or otherwise. -- Tables to follow –DIADEXUS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except share data)
(unaudited)Three Months Ended September 30,Nine Months Ended September 30,2010200920102009Revenues:License revenue$
236Royalty revenue8829802,6273,194Product sales2,0141,0485,0744,181Product sales to related party1813915211,174Total revenues3,1532,4988,4518,785Operating costs and expenses:Product costs1,1358073,3822,570Sales and marketing1,3841,7474,0365,175Research and development1,6049393,5842,901General and administrative1,8616853,5202,292Total operating costs and expenses5,9844,17814,52212,938Loss from operations(2,831)(1,680)(6,071)(4,153)Other (loss) incomeInterest and other income6210669314Interest and other expense(58)(171)(356)(857)Total other (loss) income4(65)(287)(543)Net loss$
(4,696)Basic and diluted net loss per share:$
(0.25)Weighted average shares used in computing basic and diluted net loss per share43,086,47419,059,14427,156,26619,059,144DIADEXUS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(In thousands, except share data)September 30,
2009(unaudited)AssetsCurrent assets:Cash and cash equivalents$
2,539Short-term investment securities—2,262Accounts receivable 1,2651,637Receivable from related party196295Inventories106221Restricted cash400—Assets held for sale310—Prepaid expenses and other current assets1,155618Total current assets26,6707,572Restricted cash1,400400Property and equipment, net7841,366Other long-term assets3130Total assets$
9,468Liabilities, Convertible Preferred Stock and Stockholders' Equity (Deficit)Current liabilities:Accounts payable$
273Notes payable—3,498Deferred revenues, current portion344318Deferred rent, current portion156194Unfavorable lease obligations383—Accrued and other current liabilities1,7471,922Total current liabilities3,3666,205Long-term deferred rent—103Non-current portion of unfavorable lease obligation3,649—Non-current portion of deferred revenue9121,140Warrant liability—36Other long term liabilities1,058—Total liabilities8,9857,484Commitments and contingenciesConvertible preferred stock—168,242Stockholders' equity (deficit):Common stock53118Additional paid-in capital204,71412,739Accumulated deficit (185,373)(179,015)Total stockholders' equity (deficit)19,872(166,258)Total liabilities, convertible preferred stock and stockholders' equity (deficit)$
The balance sheet at December 31, 2009 has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.
|SOURCE diaDexus, Inc.|
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