-----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, WrZ4Nwt/ZHUBPcoE3/FDlFj9fEjRqfq8+2qJaNOHFRx2KnmA2b2WrhM/b1nPtvAi 6iG3bEtO4f0AMh6Ca4xNZg== 0000950134-06-008769.txt : 20060504 0000950134-06-008769.hdr.sgml : 20060504 20060504161513 ACCESSION NUMBER: 0000950134-06-008769 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20060504 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060504 DATE AS OF CHANGE: 20060504 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ADEZA BIOMEDICAL CORP CENTRAL INDEX KEY: 0000902482 STANDARD INDUSTRIAL CLASSIFICATION: INSTRUMENTS FOR MEAS & TESTING OF ELECTRICITY & ELEC SIGNALS [3825] IRS NUMBER: 770054952 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-20703 FILM NUMBER: 06808566 BUSINESS ADDRESS: STREET 1: 1240 ELKO DR CITY: SUNNYVALE STATE: CA ZIP: 94089 8-K 1 f20246e8vk.htm FORM 8-K e8vk
Table of Contents

 
 
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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): May 4, 2006
Adeza Biomedical Corporation
(Exact name of registrant as specified in its charter)
000-20703
(Commission File Number)
     
Delaware
  77-0054952
(State or other jurisdiction of
  (I.R.S. Employer Identification No.)
incorporation)
   
1240 Elko Drive
Sunnyvale, California 94089

(Address of principal executive offices, with zip code)
(408) 745-0975
(Registrant’s telephone number, including area code)
(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))
 
 

 


TABLE OF CONTENTS

Item 2.02 Results of Operations and Financial Condition
Item 8.01 Other Events
Item 9.01 Financial Statements and Exhibits
SIGNATURES
EXHIBIT INDEX
EXHIBIT 99.1
EXHIBIT 99.2


Table of Contents

Item 2.02 Results of Operations and Financial Condition
     On May 4, 2006 Adeza Biomedical Corporation (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2006. The press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
Item 8.01 Other Events
     On May 4, 2006, the Company issued a press release announcing the submission to the United States Food and Drug Administration of a new drug application for GestivaTM, its product candidate for the prevention of recurrent preterm birth. The press release is attached hereto as Exhibit 99.2 and incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits
     (c) Exhibits.
         
 
  Exhibit 99.1   Press release dated May 4, 2006
 
       
 
  Exhibit 99.2   Press release dated May 4, 2006

 


Table of Contents

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.
         
    ADEZA BIOMEDICAL CORPORATION
 
       
Date: May 4, 2006
  By:        /s/          Mark D. Fischer Colbrie
 
       
 
      Mark D. Fischer-Colbrie
 
      Vice President, Finance and Administration and Chief
 
      Financial Officer

 


Table of Contents

EXHIBIT INDEX
     
Exhibit    
number   Description
99.1
  Press release dated May 4, 2006
 
   
99.2
  Press release dated May 4, 2006

 

EX-99.1 2 f20246exv99w1.htm EXHIBIT 99.1 exv99w1
 

EXHIBIT 99.1
         
COMPANY CONTACT:
      INVESTOR CONTACTS:
 
       
Mark Fischer-Colbrie
      Jody Cain (jcain@lhai.com)
 
       
Chief Financial Officer
      Bruce Voss (bvoss@lhai.com)
 
       
Adeza Biomedical Corporation
      Lippert/Heilshorn & Associates, Inc.
 
       
(408) 745-0975 ext 520
      (310) 691-7100
 
       
ir@adeza.com
       
For Immediate Release
ADEZA ANNOUNCES 2006 FIRST QUARTER FINANCIAL RESULTS
Company Affirms 2006 Revenue Guidance
Announces Nationwide Availability Through Quest Diagnostics
Conference Call to Discuss Gestiva and First Quarter Financial Results
Begins at 4:30 p.m. Eastern Time Today
SUNNYVALE, Calif. (May 4, 2006) – Adeza (NASDAQ: ADZA) today announced financial results for the three months ended March 31, 2006.
For the first quarter of 2006 Adeza reported product sales of $10.8 million, an increase of 12% from product sales of $9.6 million for the first quarter of 2005. This increase is due to higher sales volume of FullTerm™, The Fetal Fibronectin Test. Sales during the first quarter of 2006 reflect the impact of ordering cycles by Adeza customers and to a lesser extent product pricing.
Net income for the first quarter of 2006 was $6,000, or diluted earnings per share of $0.00. Reported results for the first quarter of 2006 include charges of $915,000, or $0.03 per diluted share after income tax expense, for stock-based compensation due to the adoption of SFAS 123R. Net income for the first quarter of 2005 was $1.5 million, or diluted earnings per share of $0.08.
The gross profit for the 2006 first quarter was $9.0 million, or 83.7%, and includes stock-compensation expense of $46,000. This compares with gross profit of $8.2 million, or 85.2%, for the prior-year first quarter.
Selling and marketing expenses for the 2006 first quarter were $6.0 million including stock-compensation expense of $482,000, up from $4.7 million for the comparable quarter in 2005, reflecting expansion of the company’s direct sales force. General and administrative expenses for the quarter were $2.3 million including stock-compensation expense of $341,000, up from $1.5 million in the comparable quarter of the prior year, due primarily to costs associated with operating as a public company. Research and development expenses were $1.7 million for the first quarter of 2006 including stock-compensation expense of $46,000, compared with $864,000 in the comparable quarter of the prior year, with the increase due mainly to costs related to product development efforts, including costs related to Gestiva™, Adeza’s drug candidate for the prevention of preterm birth in women who have a history of preterm delivery.

 


 

As of March 31, 2006 Adeza had cash and cash equivalents of $90.5 million, compared with $89.7 million as of December 31, 2005. Stockholders’ equity was $98.6 million and working capital was $97.9 million as of March 31, 2006.
“We are extremely pleased to announce our submission of a New Drug Application to the FDA for a major product candidate, Gestiva,” said Emory V. Anderson, president and chief executive officer. “We were able to accomplish this milestone without incurring the expenses typically related to new drug development while maintaining profitability.
“As also announced today, the nationwide availability of FullTerm, The Fetal Fibronectin Test through Quest Diagnostics better positions us to further penetrate the fetal fibronectin test market, particularly for women at risk for preterm birth. Quest, with its extensive network of laboratories, will collect fetal fibronectin test samples directly from physicians’ offices and clinics throughout the United States. We look forward to increasing product sales through this new Quest program which allows for more convenient access to our test by physicians around the country,” he said.
“While we continue to report double-digit year-over-year revenue growth, our first quarter revenue results reflect the fact that customers do order products quarterly or semi-annually, so that the timing of those orders can impact our quarterly results,” he added. “Our first quarter expenses were in line with our expectations, and reflect costs associated with our annual sales meeting and a full quarter’s impact of hiring 10 sales representatives.”
2006 Financial Guidance
Adeza today affirmed guidance for 2006 revenue to be in the range of $54 million to $57 million. It also affirms that gross margin for 2006 is expected to exceed 80%, and that the full-year tax rate will be between 45% and 49%, which is higher than the statutory tax rate primarily as a result of accounting for stock-based compensation expense under SFAS 123R. Adeza expects SFAS 123R compensation expenses for 2006 to be in the range of $2.8 million to $3.2 million, before costs associated with the issuance of new option grants.
Conference Call
Adeza’s management will host an investment-community conference call today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss these results, the Gestiva announcement also made today, and to answer questions.
Individuals interested in participating in the conference call may do so by dialing (888) 463-4383 for domestic callers, or (706) 634-5615 for international callers. A telephone replay will be available for 48 hours following the conclusion of the call by dialing (800) 642-1687 for domestic callers, or (706) 645-9291 for international callers, and entering reservation code 8492565.
The live call also will be available via the Internet on the Investors section of the company’s Web site at www.adeza.com. A webcast replay of the call will be available following the conclusion of the call.
About Adeza
Adeza designs, manufactures and markets innovative products for women’s health. Adeza’s initial focus is on reproductive healthcare, using its proprietary technologies to predict preterm birth and assess infertility. Adeza’s principal product is a patented diagnostic test, FullTerm, The Fetal Fibronectin Test, which utilizes a single-use, disposable cassette and is analyzed on Adeza’s patented TLiIQ® System. This product is approved by the U.S. Food and Drug Administration (FDA) for use in assessing the risk of preterm birth. Adeza also markets and sells the E-tegrity® Test, an infertility-related test to assess receptivity of the uterus to embryo implantation in women with unexplained infertility.

 


 

Adeza cautions you that statements included in this press release that are not a description of historical facts may be forward-looking statements, including, for example, statements relating to Adeza’s future financial results, its sales and marketing strategy, its association with Quest Diagnostics and its product candidate Gestiva. The inclusion of forward-looking statements should not be regarded as a representation by Adeza that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Adeza’s business including, without limitation, risks and uncertainties relating to the expansion of products, markets and offerings and additional product indications, risks associated with the regulatory approval process for product candidates, and risks associated with being in both the diagnostic and therapeutic businesses. Further information about these and other risks is included in the Company’s Annual Report on Form 10-K and other periodic and current reports filed by Adeza with the Securities Exchange Commission, which are available from the SEC’s website (www.sec.gov), and also available on the Investor Relations section of our website. All forward-looking statements are qualified in their entirety by this cautionary statement and Adeza undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.
[Tables to follow]

 


 

Adeza
Condensed Statements of Operations

(in thousands, except share and per share information)
                 
    Three Months Ended  
    March 31,  
    (unaudited)     (unaudited)  
    2006     2005  
 
Product sales
  $ 10,793     $ 9,610  
Cost of product sales
    1,755       1,427  
 
           
Gross profit
    9,038       8,183  
Operating costs and expenses:
               
Selling and marketing
    6,045       4,725  
General and administrative
    2,302       1,537  
Research and development
    1,673       864  
 
           
Total operating costs and expenses
    10,020       7,126  
 
           
Income (loss) from operations
    (982 )     1,057  
Interest income
    994       480  
 
           
Income before income taxes
    12       1,537  
Provision for income taxes
    6       81  
 
           
Net income
  $ 6     $ 1,456  
 
           
Basic net income per share
  $ 0.00     $ 0.09  
 
           
 
Diluted net income per share
  $       $ 0.08  
 
           
 
  $ 0.00          
 
             
Shares used to compute basic net income per share
    17,416,232       16,527,243  
 
           
Shares used to compute diluted net income per share
    18,235,047       17,773,973  
 
           

 


 

Adeza
Condensed Balance Sheets

(in thousands, except share and per share information)
                 
    March 31,     December 31,  
    2006     2005  
 
    (unaudited)          
Assets
               
Current assets:
               
Cash and cash equivalents
  $ 90,511     $ 89,722  
Accounts receivable, net
    8,069       9,182  
Inventories
    932       849  
Prepaid and other current assets
    318       292  
Current deferred tax asset
    4,929       4,929  
 
           
Total current assets
    104,759       104,974  
Property and equipment, net
    387       348  
Noncurrent deferred tax asset
    193       193  
Intangible assets, net
    116       128  
 
           
Total assets
  $ 105,455     $ 105,643  
 
           
 
               
Liabilities and stockholders’ equity
               
Current liabilities:
               
Accounts payable
  $ 2,197     $ 1,994  
Accrued compensation
    1,545       2,216  
Accrued royalties
    671       1,427  
Other accrued liabilities
    1,108       1,246  
Taxes payable
    1,294       1,322  
Deferred revenue
    17       33  
 
           
Total current liabilities
    6,832       8,238  
Commitments Stockholders’ equity:
               
Common stock, $0.001 par value; 100,000,000 shares authorized; 17,446,415 and 17,376,330 shares issued and outstanding at March 31, 2006 and December 31, 2005, respectively
    17       17  
Additional paid-in capital
    131,027       132,432  
Deferred compensation
          (2,604 )
Unrealized Gain on investments
    13        
Accumulated deficit
    (32,434 )     (32,440 )
 
           
Total stockholders’ equity
    98,623       97,405  
 
           
Total liabilities and stockholders’ equity
  $ 105,455     $ 105,643  
 
           
# # #

 

EX-99.2 3 f20246exv99w2.htm EXHIBIT 99.2 exv99w2
 

EXHIBIT 99.2
         
COMPANY CONTACT:
      INVESTOR CONTACTS:
 
       
Mark Fischer-Colbrie
      Jody Cain (jcain@lhai.com)
 
       
Chief Financial Officer
      Bruce Voss (bvoss@lhai.com)
 
       
Adeza Biomedical Corporation Inc.
      Lippert/Heilshorn & Associates,
 
       
(408) 745-0975 ext 520
      (310) 691-7100
 
       
ir@adeza.com
       
For Immediate Release
ADEZA SUBMITS NEW DRUG APPLICATION FOR GESTIVA
TO PREVENT PRETERM BIRTHS
NIH Study Finds 34% Reduction in Preterm Births; Therapy Recommended by ACOG
Conference Call to Discuss Gestiva and First Quarter Financial Results
Begins at 4:30 p.m. Eastern Time Today
SUNNYVALE, Calif. (May 4, 2006) – Adeza (NASDAQ: ADZA) today announced the submission of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Gestiva™, the company’s drug candidate to prevent preterm birth in women with a history of preterm delivery.
Adeza has requested Priority Review for the Gestiva NDA that, if granted, would set a six month goal for review by the FDA. Adeza has also submitted an application to the FDA requesting Orphan Drug designation. Gestiva is a long-acting, naturally occurring form of progesterone. If Gestiva is approved, Adeza will have the only commercially available, NIH-studied, ACOG-recommended and FDA-approved therapeutic for the prevention of recurrent preterm birth.
Preterm birth is defined as delivery before 37 completed weeks of gestation. According to the New England Journal of Medicine, preterm births have historically accounted for up to 85% of all pregnancy-related complications and deaths in the United States. The March of Dimes estimates that more than $18.1 billion in costs were associated with the care of preterm or low-birth-weight infants in 2003. Women with a history of preterm birth represent one of the highest risk groups for a future preterm delivery. Adeza believes that treating women in this group with Gestiva has the potential to significantly reduce preterm birth costs.
“Gestiva represents an ideal strategic fit for Adeza and is consistent with our mission to market and sell a broad array of high-value innovative products addressing women’s healthcare,” said Emory V. Anderson, president and chief executive officer. “If Gestiva is approved, the Adeza 87-person sales force will market Gestiva to the same physicians to whom we market FullTerm™, The Fetal Fibronectin Test, thereby leveraging our direct sales efforts.”

 


 

“OB/GYNs are beginning to use this form of progesterone in women with a history of prior preterm birth based on a 2003 American College of Obstetricians and Gynecologists (ACOG) recommendation that followed an NIH study published in the June 2003 New England Journal of Medicine. Currently, this form of progesterone is prepared solely by compounding pharmacies. Subject to approval, Gestiva will be widely available and manufactured under strict FDA requirements,” said Durlin E. Hickok, MD, vice-president, medical affairs. “Preterm birth is a major health problem and Adeza is excited about the opportunity to help infants and families.”
Background to Gestiva
Adeza’s NDA submission for Gestiva includes data from a clinical study conducted by the National Institute of Child Health and Human Development, one of the institutes of the NIH. The NIH studied a long-acting form of a naturally occurring progesterone, 17 alpha-hydroxyprogesterone caproate (17P), in a multi-center, double-blind, placebo-controlled trial that enrolled 463 women with a prior history of preterm birth. Patients were enrolled at 16 to 21 weeks of gestation and randomly assigned to receive weekly injections of 17P or placebo. Treatment continued until delivery or 37 weeks of gestation, resulting in a reduction in the preterm birth rate of 34% among women treated with 17P. In addition, infants born to women treated with 17P had significantly lower rates of necrotizing enterocolitis, intraventricular hemorrhage, use of supplemental oxygen, and mean number of days of respiratory therapy.
Conference Call
Adeza’s management will host an investment-community conference call today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss Gestiva and first quarter financial results.
Individuals interested in participating in the conference call may do so by dialing (888) 463-4383 for domestic callers, or (706) 634-5615 for international callers. A telephone replay will be available for 48 hours following the conclusion of the call by dialing (800) 642-1687 for domestic callers, or (706) 645-9291 for international callers, and entering reservation code 8492565.
The live call also will be available via the Internet on the Investors section of the company’s Web site at www.adeza.com. A webcast replay of the call will be available following the conclusion of the call.
About Adeza
Adeza designs, manufactures and markets innovative products for women’s health. Adeza’s initial focus is on reproductive healthcare, using its proprietary technologies to predict preterm birth and assess infertility. Adeza’s principal product is a patented diagnostic test, FullTerm, The Fetal Fibronectin Test, which utilizes a single-use, disposable cassette and is analyzed on Adeza’s patented TLiIQ® System. This product is approved by the FDA for use in assessing the risk of preterm birth. Adeza also markets and sells the E-tegrity® Test, an infertility-related test to assess receptivity of the uterus to embryo implantation in women with unexplained infertility. More information is available at www.adeza.com.
Adeza cautions you that statements included in this press release that are not a description of historical facts may be forward-looking statements, including, for example, statements regarding the regulatory path for Gestiva and marketing plans for Gestiva. The inclusion of forward-looking statements should not be regarded as a representation by Adeza that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Adeza’s business including, without limitation, statements about its business and marketing strategy, its business and marketing execution, risks associated with regulatory review, including the timing of regulatory approval, and risks associated with being in both the diagnostic and therapeutic businesses. Further

 


 

information about these and other risks is included Adeza’s Annual Report on Form 10-K and other periodic and current reports filed by Adeza with the Securities Exchange Commission, which are available from the SEC’s website (www.sec.gov), and also available on the Investors section of Adeza’s website. All forward-looking statements are qualified in their entirety by this cautionary statement and Adeza undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.
# # #

 

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