UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 15, 2011
DIADEXUS, INC.
(Exact Name of Registrant as Specified in its Charter)
Delaware | 0-26483 | 94-3236309 | ||
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
343 Oyster Point Boulevard, South San Francisco, California 94080
(Address of Principal Executive Offices) (Zip Code)
Registrants telephone number, including area code: (650) 246-6400
N/A
(Former Name or Former Address, if Changed Since Last Report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions ( see General Instruction A.2. below):
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02. | Results of Operations and Financial Condition. |
On August 15, 2011, diaDexus, Inc. (the Company) issued a press release announcing financial results for the fiscal quarter ended June 30, 2011. A copy of the press release is furnished as Exhibit 99.1 to this report.
The information furnished pursuant to this Item 2.02 of this report, including the exhibit attached hereto, shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Securities Exchange Act of 1934, as amended, regardless of any general incorporation language in any such filing, unless the Company expressly sets forth in such filing that such information is to be considered filed or incorporated by reference therein.
Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
Exhibit No. |
Description | |
99.1 | Press release |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
diaDexus, Inc. | ||||||
(Registrant) | ||||||
Date: August 15, 2011 | ||||||
By: | /s/ James P. Panek | |||||
James P. Panek | ||||||
Interim President and Chief Executive Officer |
EXHIBIT INDEX
Exhibit No. |
Description | |
99.1 | Press release |
Exhibit 99.1
diaDexus, Inc. Reports 45% Year-Over-Year Revenue Growth for 2011 Second
Quarter
SOUTH SAN FRANCISCO, Calif., August 15, 2011 diaDexus, Inc. (OTC Bulletin Board: DDXS.OB), 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 second quarter of 2011.
Total revenues for the quarter ended June 30, 2011 were $3.8 million, representing 45% growth over total revenues of $2.6 million for the second quarter of 2010, and a 15% increase over first quarter 2011 revenues. Total operating costs and expenses for the quarter were $6.3 million as compared to $4.6 million for the 2010 second quarter, with the increase in expenses primarily related to the requirements of public company reporting, costs associated with a building lease entered into by VaxGen, Inc. prior to the July 2010 reverse merger transaction, and severance costs related to the resignation of the companys former CEO. Net cash used in operating activities for the second quarter of 2011 declined to $1.4 million versus $1.8 million for the same period the year prior, and down from $1.9 million in the first quarter of 2011.
As of June 30, 2011, diaDexus had cash, cash equivalents, and investments of $16.8 million, compared to $18.5 million at March 31, 2011.
Commenting on the financial results, Interim Chief Executive Officer James Panek stated, The second quarter results reflect better than expected sales of our PLAC ELISA Test to several laboratory customers, and marks our fourth consecutive quarter of revenue growth. The strength of our sales during the first half of 2011 has largely mitigated the impact of not reintroducing the PLAC TIA product, and we believe that we will achieve full year total revenues at the upper end of our previous guidance for 2011.
Guidance
diaDexus said that it expects 2011 total revenue to be at the upper end of its previous guidance of $12 13 million. This guidance reflects no revenue expectation from the PLAC TIA product in 2011. The company anticipates that its 2011 capital expenditures will be higher than previous estimates, but is not providing updated guidance at this time. The increase is due primarily to costs associated with the consolidation of its operations into one leased building, and equipment purchases associated with increased PLAC ELISA sales and anticipated commercialization of its Lp-PLA2 Activity assay. The company also said it is maintaining its guidance for net cash used in operating activities at $10 12 million, and that it has sufficient cash through at least the middle of 2012, based on its current operating plan. Future financing needs will depend on the companys ability to increase the rate of adoption of the companys products by physicians and laboratories and progress in achieving additional positive coverage decisions from insurers for the PLAC Test.
Webcast
diaDexus said it is hosting a webcast on Monday, August 15 at 1:30 PM PDT (4:30 PM EDT) to discuss the 2011 second quarter financial results. The webcast may be accessed via the companys 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 companys 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 companys website at www.diaDexus.com.
Forward-Looking Statements
This 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 companys plans, objectives, expectations and intentions with respect to future financial results, operations and products and other statements that are not historical in nature, particularly those that use terminology such as will, potential, could, can, believes, 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 maintain regulatory clearance for and successfully commercialize its PLAC Test, including its new automated Lp-PLA2 activity assay and any new diagnostic products; its ability to hire and retain a chief executive officer and chief financial officer, and to attract, retain and motivate other qualified personnel; its relationship with key customers; diaDexus reliance on sole source third party manufacturers to manufacture and supply our main reagent and the PLAC Test; the effects of government regulations and the companys ability to comply with such regulations; 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; third party payors acceptance of and reimbursement for the PLAC Test; diaDexus limited revenue and cash resources; the adequacy of the companys intellectual property rights; and diaDexus significant corporate expenses, including expenses associated with being a public company and real estate liabilities. 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 annual report on Form 10-K, subsequent quarterly reports on Form 10-Q, and other reports filed with the Securities and Exchange Commission, which are available at the SECs 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 June 30, |
Six Months Ended June 30, |
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2011 | 2010 | 2011 | 2010 | |||||||||||||
Revenues: |
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License revenue |
$ | 77 | $ | 77 | $ | 153 | $ | 153 | ||||||||
Royalty revenue |
944 | 866 | 1,949 | 1,745 | ||||||||||||
Product sales |
2,646 | 1,548 | 4,886 | 3,060 | ||||||||||||
Product sales to related party |
160 | 141 | 160 | 340 | ||||||||||||
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Total revenues |
3,827 | 2,632 | 7,148 | 5,298 | ||||||||||||
Operating costs and expenses: |
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Product costs |
1,205 | 1,260 | 2,337 | 2,247 | ||||||||||||
Sales and marketing |
977 | 1,374 | 2,084 | 2,652 | ||||||||||||
Research and development |
1,274 | 1,047 | 2,766 | 1,979 | ||||||||||||
General and administrative |
2,842 | 930 | 4,956 | 1,655 | ||||||||||||
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Total operating costs and expenses |
6,298 | 4,611 | 12,143 | 8,533 | ||||||||||||
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Loss from operations |
(2,471 | ) | (1,979 | ) | (4,995 | ) | (3,235 | ) | ||||||||
Interest income, interest expense and other income (expense), net: |
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Interest income |
15 | 1 | 32 | 4 | ||||||||||||
Interest expense |
| (186 | ) | | (298 | ) | ||||||||||
Other income (expense), net |
| 1 | | 3 | ||||||||||||
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Loss before income tax |
(2,456 | ) | (2,163 | ) | (4,963 | ) | (3,526 | ) | ||||||||
Income tax |
| | (3 | ) | (5 | ) | ||||||||||
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Net loss |
$ | (2,456 | ) | $ | (2,163 | ) | $ | (4,966 | ) | $ | (3,531 | ) | ||||
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Basic and diluted net loss per share: |
$ | (0.05 | ) | $ | (0.11 | ) | $ | (0.09 | ) | $ | (0.19 | ) | ||||
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Weighted average shares used in computing basic and diluted net loss per share |
53,067,057 | 19,059,144 | 53,067,057 | 19,059,144 | ||||||||||||
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DIADEXUS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share data)
June 30, 2011 |
December 31, 2010* |
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(unaudited) | ||||||||
Assets |
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Current assets: |
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Cash and cash equivalents |
$ | 6,083 | $ | 20,394 | ||||
Short-term marketable securities |
9,726 | | ||||||
Accounts receivable |
1,329 | 1,543 | ||||||
Receivable from related party |
| 175 | ||||||
Inventories |
128 | 105 | ||||||
Restricted cash |
400 | | ||||||
Assets held for sale |
308 | 308 | ||||||
Prepaid expenses and other current assets |
1,355 | 1,046 | ||||||
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Total current assets |
19,329 | 23,571 | ||||||
Long-term investments |
1,000 | | ||||||
Restricted cash |
1,400 | 1,800 | ||||||
Property and equipment, net |
465 | 580 | ||||||
Other long-term assets |
35 | 128 | ||||||
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Total assets |
$ | 22,229 | $ | 26,079 | ||||
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Liabilities and Stockholders Equity |
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Current liabilities: |
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Accounts payable |
$ | 503 | $ | 445 | ||||
Deferred revenues, current portion |
322 | 305 | ||||||
Deferred rent, current portion |
42 | 103 | ||||||
Unfavorable lease obligations |
426 | 363 | ||||||
Accrued and other current liabilities |
2,674 | 1,930 | ||||||
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Total current liabilities |
3,967 | 3,146 | ||||||
Long-term deferred rent |
159 | 52 | ||||||
Non-current portion of unfavorable lease obligation |
3,315 | 3,555 | ||||||
Non-current portion of deferred revenue |
683 | 835 | ||||||
Other long term liabilities |
766 | 646 | ||||||
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Total liabilities |
8,890 | 8,234 | ||||||
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Stockholders equity: |
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Preferred stock |
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Common stock |
531 | 531 | ||||||
Additional paid-in capital |
205,236 | 204,774 | ||||||
Accumulated other comprehensive loss |
(2 | ) | | |||||
Accumulated deficit |
(192,426 | ) | (187,460 | ) | ||||
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Total stockholders equity |
13,339 | 17,845 | ||||||
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Total liabilities and stockholders equity |
$ | 22,229 | $ | 26,079 | ||||
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* | The balance sheet at December 31, 2010 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. |