Home > Press > Nanosphere Announces Third Quarter 2008 Results: Files FDA 510(k) Submissions for Two New Assays
Abstract:
Nanosphere, Inc. (Nasdaq:NSPH), a leader in the development and commercialization of advanced molecular diagnostics systems, today reported financial results for the third quarter and nine months ended September 30, 2008 and announced the filing of FDA 510(k) submissions for two new assays.
"We are making good progress toward our 2008 objectives including system placements and product development programs. Although product revenue was up slightly on a sequential basis from the second quarter, we do not expect to see significant revenue growth until we expand our test menu. Toward that end, we have filed FDA 510(k) submissions for two new products, a cystic fibrosis assay and a respiratory assay panel that tests for viruses including influenza A/B and RSV A/B. Moreover, development of additional assays, including our cardiac troponin I test for earlier detection of cardiovascular disease, are on track," said William Moffitt, Nanosphere's president and chief executive officer.
During the third quarter of 2008, revenue from sales of the Verigene System and test cartridges was $210,000 compared to $195,000 in the second quarter and $6,000 for the third quarter of 2007. Revenue was primarily from cartridge sales and rental agreements. Revenue from contracts and government grants during the third quarter of 2008 was $73,000 compared to $193,000 a year ago.
For the nine months ended September 30, 2008, revenue was $1,054,000 compared with $979,000 recorded in the comparable period in 2007. Product revenue increased to $708,000 for the first nine months of 2008 from $60,000 in the same period in 2007. Revenue from contracts and government grants was $346,000 for the nine months ended September 30, 2008 and $919,000 for the nine months ended September 30, 2007.
Research and development expense of $5.7 million for the three months ended September 30, 2008, was essentially unchanged from $5.8 million for the same period in 2007. For the nine months ended September 30, 2008, R&D expense rose to $17.6 million from $16.3 million for the nine months ended September 30, 2007. This increase in spending reflects investment in new products such as our protein assay to detect cardiac troponin I, additional human genetic and infectious disease assays and our Verigene II platform.
Sales, general and administrative expense decreased to $3.4 million for the three months ended September 30, 2008, from $4.4 million for the three months ended September 30, 2007 due primarily to a non-recurring compensation expense of $1.7 million in the prior year. For the nine months ended September 30, 2008, SG&A expense increased to $10.6 million, from $9.7 million for the comparable period a year ago, primarily due to incremental investment in sales personnel and other marketing expenses to support the sales of the Verigene System.
Conference Call Details
The company will hold a live conference call and webcast for investors on Monday, November 10, 2008 at 5:00 P.M., Eastern Daylight Time. The teleconference can be accessed by dialing 888-680-0878 (U.S./Canada) or 617-213-4855 (international), participant code 99658916. The call will also be broadcast live over the Internet and can be accessed by interested parties at the Investor Relations tab on the Nanosphere website: www.nanosphere.us. For interested individuals unable to join the call or webcast, a replay will be available through November 24, 2008, by dialing 888-286-8010 or for international calls, 617-801-6888, pass code 64293975, or on the company's website.
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About Nanosphere, Inc.
Nanosphere develops, manufactures and markets an advanced molecular diagnostics platform, the Verigene(r) System, for direct genomic and ultra-sensitive protein detection. This easy to use and cost effective platform enables simple, low cost and highly sensitive genomic and protein testing on a single platform. Nanosphere is based in Northbrook, IL.
Except for historical information, the matters discussed in this press release are "forward-looking statements" and are subject to risks and uncertainties. Actual results could differ materially from these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, the following: (i) Nanosphere's ability to develop commercially viable products; (ii) Nanosphere's ability to achieve profitability; (iii) Nanosphere's ability to produce and market its products; (iv) Nanosphere's ability to obtain regulatory approval of its products; (v) Nanosphere's ability to protect its intellectual property; (vi) competition and alternative technologies; and (vii) Nanosphere's ability to obtain additional financing, if and when necessary, to support its operations. Additional risks are discussed in the Company's current filings with the Securities and Exchange Commission. Although the Company believes the expectations reflected in such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. The forward-looking statements are made as of the date of this press release, and we undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Nanosphere, Inc. Statements of Operations (Unaudited) Three Month Periods Ended Nine Month Periods Ended September 30, September 30, ------------------------------------------------------ 2008 2007 2008 2007 ------------ ------------ ------------ ------------ (As Adjusted) (As Adjusted) REVENUE: Grant and contract revenue $ 73,459 $ 192,880 $ 346,071 $ 919,383 Product sales 209,772 6,125 707,891 59,795 ------------ ------------ ------------ ------------ Total revenue 283,231 199,005 1,053,962 979,178 COSTS AND EXPENSES: Cost of product sales 246,128 2,844 821,733 21,211 Research and development 5,683,346 5,778,946 17,631,003 16,287,056 Sales, general, and admini- strative 3,376,807 4,429,214 10,563,212 9,685,797 ------------ ------------ ------------ ------------ Total costs and expenses 9,306,281 10,211,004 29,015,948 25,994,064 ------------ ------------ ------------ ------------ Loss from operations (9,023,050) (10,011,999) (27,961,986) (25,014,886) OTHER INCOME (EXPENSE): Change in fair value of convertible derivative liability -- (11,888,721) -- (11,888,721) Change in fair value of preferred stock warrants -- (4,858,974) -- (5,135,586) Foreign exchange (gain) loss 1,347 (27,175) (23,298) (40,945) Interest expense (499,836) (572,772) (1,630,464) (1,396,520) Interest income 495,067 286,654 1,973,984 1,045,087 ------------ ------------ ------------ ------------ Total other income (expense) (3,422) (17,060,988) 320,222 (17,416,685) ------------ ------------ ------------ ------------ NET LOSS (9,026,472) (27,072,987) (27,641,764) (42,431,571) Accumulated convertible preferred stock dividends -- (1,652,493) -- (4,832,822) Convertible preferred stock redemption value adjustment -- -- -- (608,940) ------------ ------------ ------------ ------------ NET LOSS ATTRIBUTABLE TO COMMON STOCK $ (9,026,472) $(28,725,480) $(27,641,764) $(47,873,333) ============ ============ ============ ============ Net loss per common share -- basic and diluted $ (0.41) $ (30.80) $ (1.24) $ (51.33) Weighted average number of common shares outstanding -- basic and diluted 22,228,539 932,646 22,207,843 932,646 Nanosphere, Inc. Condensed Balance Sheets (Unaudited) September 30, December 31, 2008 2007 ------------ ------------ As Adjusted Cash and cash equivalents $ 83,742,196 $114,312,573 Other current assets 2,738,028 2,674,205 ------------ ------------ Total current assets 86,480,224 116,986,778 Net property and equipment 7,924,030 7,033,597 Intangible assets - net of accumulated amortization 1,526,471 1,779,934 Other assets 136,373 163,553 ------------ ------------ Total assets $ 96,067,098 $125,963,862 ============ ============ Current liabilities 8,243,278 9,301,903 Long term liabilities 4,450,313 7,462,237 Total stockholders' equity (deficit) 83,373,507 109,199,722 ------------ ------------ Total liabilities and stockholders' equity $ 96,067,098 $125,963,862 ============ ============
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Contacts:
Nanosphere, Inc.
Investors:
Roger Moody, Chief Financial Officer
847-400-9021
The Torrenzano Group
Media:
Rick Anderson
212-681-1700, Ext. 115
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