-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, KDwX9fhq8iUSIWd7Ywu5apo1KZAgZQ61nXOSSJAqn6lBpRVXn9JES8kfEvv3BQzG R6VJjPmqZ4y6j2JrDJidcg== 0001140361-10-045759.txt : 20101115 0001140361-10-045759.hdr.sgml : 20101115 20101115170754 ACCESSION NUMBER: 0001140361-10-045759 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20101115 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20101115 DATE AS OF CHANGE: 20101115 FILER: COMPANY DATA: COMPANY CONFORMED NAME: diaDexus, Inc. CENTRAL INDEX KEY: 0001036968 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 943236309 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-26483 FILM NUMBER: 101193735 BUSINESS ADDRESS: STREET 1: 343 OYSTER POINT BOULEVARD CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 BUSINESS PHONE: 650-246-6400 MAIL ADDRESS: STREET 1: 343 OYSTER POINT BOULEVARD CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 FORMER COMPANY: FORMER CONFORMED NAME: VAXGEN INC DATE OF NAME CHANGE: 19990329 8-K 1 form8k.htm DIADEXUS, INC 8-K 11-15-2010 form8k.htm


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): November 15, 2010
 
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)
 
Registrant’s telephone number, including area code: (650) 624-1000

  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):

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o 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 November 15, 2010, diaDexus, Inc. (the “Company”) issued a press release announcing financial results for the quarter ended September 30, 2010.  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: November 15, 2010
   
 
By:
/s/ David J. Foster
   
  David J. Foster
   
  Executive Vice President, Chief Financial Officer
  and Secretary

 
 

 

EXHIBIT INDEX
 
Exhibit No.
 
Description
 
 
 
 
Press release
 
 

EX-99.1 2 ex99_1.htm EXHIBIT 99.1 ex99_1.htm

Exhibit 99.1
 
diaDexus, Inc. Reports 2010 Third Quarter Financial Results
Guidance for Year-End 2010 and 2011 Outlook

 
South San Francisco, CA – November 15, 2010 – diaDexus, Inc. (OTCBB: 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 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 transa ction 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.”
 
Guidance
 
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 t o 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.
 
 
 

 

Webcast
 
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 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 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 u nknown 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 oblig ation 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,
 
 
 
2010
   
2009
   
2010
   
2009
 
Revenues:
 
 
 
 
 
 
 
 
 
 
 
 
License revenue
 
$
76
   
$
79
   
$
229
   
$
236
 
Royalty revenue
   
882
     
980
     
2,627
     
3,194
 
Product sales
   
2,014
     
1,048
     
5,074
     
4,181
 
Product sales to related party
   
181
     
391
     
521
     
1,174
 
Total revenues
   
3,153
     
2,498
     
8,451
     
8,785
 
Operating costs and expenses:
 
 
                           
Product costs
 
 
1,135
     
807
     
3,382
     
2,570
 
Sales and marketing
   
1,384
     
1,747
     
4,036
     
5,175
 
Research and development
   
1,604
     
939
     
3,584
     
2,901
 
General and administrative
 
 
1,861
     
685
     
3,520
     
2,292
 
Total operating costs and expenses
 
 
5,984
     
4,178
     
14,522
     
12,938
 
Loss from operations
 
 
(2,831
)
   
(1,680
)
   
(6,071
)
   
(4,153
)
Other (loss) income
 
 
                         
 
Interest and other income
 
 
62
     
106
     
69
     
314
 
Interest and other expense
 
 
(58)
     
(171
)
   
(356)
     
(857
)
Total other (loss) income
 
 
4
     
(65
)
   
(287)
     
(543
)
Net loss
 
$
(2,827
)
 
$
(1,745
)
 
$
(6,358
)
 
$
(4,696
)
Basic and diluted net loss per share:
 
$
(0.07
)
 
$
(0.09
)
 
$
(0.23
)
 
$
(0.25
)
Weighted average shares used in computing basic and diluted net loss per share
 
 
43,086,474
     
19,059,144
     
27,156,266
     
19,059,144
 

 
 

 

DIADEXUS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share data)
             
 
 
September 30,
2010
   
December 31,
2009
 
 
 
(unaudited)
     
 
Assets
 
     
 
     
Current assets:
 
     
 
     
Cash and cash equivalents
 
$
23,238
   
$
2,539
 
Short-term investment securities
 
 
     
2,262
 
Accounts receivable
 
 
1,265
     
1,637
 
Receivable from related party
 
 
196
     
295
 
Inventories
 
 
106
     
221
 
Restricted cash
   
400
     
 
Assets held for sale
   
310
     
 
Prepaid expenses and other current assets
 
 
1,155
     
618
 
Total current assets
 
 
26,670
     
7,572
 
Restricted cash
 
 
1,400
     
400
 
Property and equipment, net
 
 
784
     
1,366
 
Other long-term assets
 
 
3
     
130
 
Total assets
 
$
28,857
   
$
9,468
 
     
Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit)
 
             
Current liabilities:
 
             
Accounts payable
 
$
736
   
$
273
 
Notes payable
   
     
3,498
 
Deferred revenues, current portion
 
 
344
     
318
 
Deferred rent, current portion
   
156
     
194
 
Unfavorable lease obligations
   
383
     
 
Accrued and other current liabilities
 
 
1,747
     
1,922
 
Total current liabilities
 
 
3,366
     
6,205
 
Long-term deferred rent
   
     
103
 
Non-current portion of unfavorable lease obligation
 
 
3,649
     
 
Non-current portion of deferred revenue
 
 
912
     
1,140
 
Warrant liability
   
     
36
 
Other long term liabilities
   
1,058
     
 
Total liabilities
   
8,985
     
7,484
 
     
Commitments and contingencies
               
                 
Convertible preferred stock
   
     
168,242
 
                 
Stockholders’ equity (deficit):
 
 
         
 
Common stock
 
 
531
     
18
 
Additional paid-in capital
 
 
204,714
     
12,739
 
Accumulated deficit
 
 
(185,373
)
   
(179,015
)
Total stockholders’ equity (deficit)
 
 
19,872
     
(166,258
)
Total liabilities, convertible preferred stock and stockholders’ equity (deficit)
 
$
28,857
   
$
9,468
 

*
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.
 
 

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