- 50 new VerigeneSP system placements double over prior quarter
- C. difficile assay filed with FDA
- FDA categorizes blood stream gram-positive test as CLIA moderate complexity
NORTHBROOK, Ill., Nov. 7, 2012 (GLOBE NEWSWIRE) -- Nanosphere, Inc. (Nasdaq:NSPH), a leader in the development and commercialization of advanced molecular diagnostics systems, today reported financial results for the third quarter ending September 30, 2012.
"Continuing positive momentum marked the quarter as we shipped 50 VerigeneSP new customer placements, the highest number in any single quarter to date," said William Moffitt, Nanosphere president and chief executive officer. "The acceleration in product placements was driven primarily by FDA clearance of our gram-positive blood culture test at the end of the second quarter. We are very encouraged with the market's response to the introduction of the gram-positive test and are working diligently to get additional content approved for VerigeneSP, including our c. difficile, gram-negative and enteric panels."
Financial Highlights
- 50 new VerigeneSP systems were placed during the quarter, bringing the cumulative number of systems placed to 216.
- Revenues for the third quarter 2012 were $865,000 compared to $556,000 for the same period 2011, driven primarily by increased consumable sales to new customers. Third quarter revenue did not include meaningful blood stream infection gram-positive sales as most new placements have taken approximately 90 days to validate the assay, after which revenue recognition commences.
- R&D expenses decreased to $4.6 million for the quarter from $5.8 million in the same period in 2011 due to reduced spending on clinical trials and reduced patent-related legal expenses.
- SG&A expenses increased in the second quarter to $4.4 million from $3.8 million in the third quarter of 2011 due to increased expenses from the expansion of our sales and customer support teams.
- Total operating expenses were $9.0 million in the quarter, down from $9.7 million in the same period of 2011.
- Net loss for the third quarter of 2012 was $8.7 million, down from $9.5 million for the same period in 2011.
- Cash and cash equivalents as of September 30, 2012 were $41.9 million.
- In July 2012, the company completed a public offering of common stock that added $27 million in net proceeds.
Clinical Highlights
- The FDA categorized Nanosphere's Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) on the Verigene System as a moderate complexity test under the Clinical Laboratory Improvement Amendments (CLIA) program, allowing for expanded decentralization of the Verigene testing platform.
- The Company submitted a 510(k) for its Clostridium difficile assay to the FDA. Initial comments and questions are expected before year end.
Conference Call Details
The company will hold a live conference call and webcast for investors on Wednesday, November 7, 2012 at 5:00 P.M., Eastern Time. The teleconference can be accessed by dialing 888-680-0879 (U.S./Canada) or 617-213-4856 (international), participant code 46512458. 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 14, 2012 by dialing 888-286-8010 or for international calls 617-801-6888, pass code 86076200, or on the company's website.
About Nanosphere, Inc.
Nanosphere develops, manufactures and markets an advanced molecular diagnostics platform, the Verigene® System, for detection of life threatening infections and cardiovascular diseases. 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. Additional information is available at http://www.nanosphere.us.
The Nanosphere, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=4344
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 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 | ||||
| (dollars and shares in thousands except per share data) | ||||
| (Unaudited) | ||||
| Three Month Periods Ended September 30, | Nine Month Periods Ended September 30, | |||
| 2012 | 2011 | 2012 | 2011 | |
| REVENUE: | ||||
| Product sales | $ 865 | $ 556 | $ 3,466 | $ 1,651 |
| Grant and contract revenue | — | — | 43 | 54 |
| Total revenue | 865 | 556 | 3,509 | 1,705 |
| COSTS AND EXPENSES: | ||||
| Cost of sales | 639 | 369 | 2,436 | 1,234 |
| Research and development | 4,584 | 5,828 | 13,735 | 15,157 |
| Sales, general, and administrative | 4,403 | 3,840 | 12,624 | 12,130 |
| Total costs and expenses | 9,626 | 10,037 | 28,795 | 28,521 |
| Loss from operations | (8,761) | (9,481) | (25,286) | (26,816) |
| OTHER INCOME (EXPENSE): | ||||
| Foreign exchange gain (loss) | (3) | (3) | (5) | (14) |
| Interest income | 15 | 11 | 42 | 33 |
| Total other income (expense) | 12 | 8 | 37 | 19 |
| NET LOSS | $ (8,749) | $ (9,473) | $ (25,249) | $ (26,797) |
| Net loss per common share — basic and diluted | $ (0.16) | $ (0.22) | $ (0.54) | $ (0.75) |
| Weighted average number of common shares outstanding — basic and diluted | 53,429 | 43,445 | 46,978 | 35,803 |
| Nanosphere, Inc. | ||
| Condensed Balance Sheets | ||
| (dollars in thousands) | ||
| (Unaudited) | ||
| September 30, | December 31, | |
| 2012 | 2011 | |
| Cash and cash equivalents | $ 41,916 | $ 39,273 |
| Other current assets | 6,700 | 3,434 |
| Total current assets | 48,616 | 42,707 |
| Net property and equipment | 2,781 | 4,522 |
| Intangible Assets - net of accumulated amortization | 2,815 | 3,033 |
| Other Assets | 75 | 75 |
| Total Assets | $ 54,287 | $ 50,337 |
| Total liabilities | $ 5,121 | $ 4,728 |
| Total stockholders' equity | 49,166 | 45,609 |
| Total liabilities and stockholders' equity | $ 54,287 | $ 50,337 |