0001121781-11-000157.txt : 20110517 0001121781-11-000157.hdr.sgml : 20110517 20110517164918 ACCESSION NUMBER: 0001121781-11-000157 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20110517 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20110517 DATE AS OF CHANGE: 20110517 FILER: COMPANY DATA: COMPANY CONFORMED NAME: GUIDED THERAPEUTICS INC CENTRAL INDEX KEY: 0000924515 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] IRS NUMBER: 582029543 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-22179 FILM NUMBER: 11852139 BUSINESS ADDRESS: STREET 1: 4955 AVALON RIDGE PKWY STREET 2: SUITE 300 CITY: NORCROSS STATE: GA ZIP: 30071 BUSINESS PHONE: 7702428723 MAIL ADDRESS: STREET 1: 4955 AVALON RIDGE PKWY STREET 2: SUITE 300 CITY: NORCROSS STATE: GA ZIP: 30071 FORMER COMPANY: FORMER CONFORMED NAME: SPECTRX INC DATE OF NAME CHANGE: 19970226 8-K 1 gthp8k51711.htm GUIDED THERAPEUTICS, INC. gthp8k51711.htm
 
 
 


 
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) May 17, 2011;  May 16, 2011
 
GUIDED THERAPEUTICS, INC.
 (Exact Name of Registrant as Specified in Its Charter)
 
         
Delaware
(State or Other Jurisdiction of Incorporation)
 
0-22179
(Commission File Number)
 
58-2029543
(IRS Employer Identification No.)

   
5835 Peachtree Corners East, Suite D
Norcross, Georgia
(Address of Principal Executive Offices)
30092
(Zip Code)
 
Registrant's Telephone Number, Including Area Code:     (770) 242-8723
 
 
 
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 :
 
 
 
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))
     
 
 
 
 
 
 

 
 
 
Section 2.02  Results of Operations and Financial Condition
 
 On May 16, 2010, the registrant publicly released its financial results for the first quarter 2011, as more fully described in the press release, a copy of which is furnished as Exhibit 99.1 hereto and which information is incorporated herein by reference.
 
Section 7.01   (Regulation FD Disclosure)
 
 On Mary 17, 2011, the registrant conducted a conference call discussing its financial results for the first quarter 2011 and other matters concerning the operation of the company, as more fully described in the prepared transcript of the call, a copy of which is furnished as Exhibit 99.2 hereto and which information is incorporated herein by reference.
  
Item 9.01  Financial Statements and Exhibits

The following exhibit is furnished with this report:
 
 Exhibit No    Description
99.1  Press Release dated May 16, 2011
99.2  Transcript
 

 
 
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.
 
 
     GUIDED THERAPEUTICS, INC  
       
   By:  /s/ MARK L. FAUPEL  
                                                                                                                                                                                                                  Mark L. Faupel, Ph.D.  
     CEO & President  
 Date:  May 17, 2011      
 
 
 
 
 
 
 
 
 
2

 
 
EX-99.1 2 ex99one.htm PRESS RELEASE DATED MAY 16, 2011 ex99one.htm
 
 

 
 
 
 
5835 Peachtree Corners east, Suite D       
Norcross, GA  30092                      
 
Contacts
Media: Deanne Eagle, Cameron Associates – 917-837-5866
Bill Wells, Guided Therapeutics – 770-242-8723
Investors: Alison Ziegler, Cameron Associates – 212-554-5469
 

 
Guided Therapeutics Reports First Quarter 2011 Results
 
Key Highlights:
 
 
·
Unveiled new LuViva™ branding and product design
 
 
·
April 2011 meeting with FDA sets path for PMA panel review of LuViva
 
 
·
Completed successful FDA inspection of cervical disease pivotal trial records
 
 
·
Extended agreements with Konica Minolta Opto, Inc. for Barrett’s esophagus product

 
Norcross, GA (May 16, 2011) -- Guided Therapeutics, Inc. (OTCBB & OTCQB: GTHP) today announced its operating results for the first quarter ended March 31, 2011.
 
Service revenue for the first quarter of 2011 was $767,000, compared to $821,000 in the first quarter of 2010.  The quarter over quarter variability is primarily due to the timing of the Konica Minolta Opto contract.
 
The net loss available to common stockholders for the first quarter of 2011 was $726,000, or $0.02 per share, compared to a net loss available to common stockholders of $3.2 million, or $0.15 per share, in the comparable quarter of 2010. The loss amount reported for the first quarter of 2010 was due primarily to non-cash interest on debt and preferred stock dividends, both of which were converted to common stock.
 
Cash on hand at March 31, 2011 was approximately $2.3 million as compared to $3.3 million at December 31, 2010.  Subsequent to the quarter end, the company received $750,000 from Konica Minolta Opto to extend the licensing agreement for the Barrett’s esophagus product for one year.  This is in addition to approximately $1.7 million the company expects to receive over the course of the next 12 months for the co-development of the Barrett’s esophagus detection product.  The company also raised approximately $179,000 from the exercise of warrants during the first quarter.
 
“We are pleased with the progress we made on a number of fronts thus far in 2011,” said Mark L. Faupel, Ph.D., Chief Executive Officer and President of Guided Therapeutics.  “In April, we held a productive meeting with the U.S. Food and Drug Administration (FDA) regarding our non-invasive cervical disease technology premarket approval (PMA) application.  Importantly, as a result of that meeting, we believe we have a clearly defined path to a panel review meeting, as well as guidance on answering the questions we received from FDA in March.  We successfully completed an FDA audit of our clinical trial records, bringing to four the number of successfully completed FDA audits in connection with our PMA application.
 
“We also received a very positive response to the new branding and industrial design of our cervical technology unveiled at major U.S. and European gynecological medical conferences over the past two weeks.  The name LuViva resonated with both women and healthcare professionals here and abroad. While we continue make tangible progress with LuViva we also are on track to begin human clinical studies of our Barrett’s Esophagus technology next month,” Dr. Faupel added.
 
###MORE###
 
 
 

 
 
 
Guided Therapeutics – 1Q 2011
May 16, 2011
Page 2
 
 
Dr. Faupel concluded, “Looking ahead, we hope to continue our preparations for the panel meeting with FDA’s guidance for responding to their questions.  Internationally, we continue to have productive discussions with potential distribution partners, and with the final industrial design now unveiled, we can move ahead with getting the CE Mark. We remain optimistic that we can meet our target to launch in late 2011 or early 2012, pending regulatory approvals.”
 
Guided Therapeutics will hold a conference call at 11:00 a.m. EDT Tuesday, May 17, 2011, to discuss its financial results and corporate developments.  Interested parties are invited to listen to the call live over the Internet at http://www.guidedinc.com/investors.htm or http://www.viavid.net.   The live call is also available by dialing (877) 627-6580 or for international callers (913) 312-0940.

A replay of the teleconference will be available on http://www.guidedinc.com/investors.htm.  A replay will also be available until May 24, 2011 by dialing (877) 870-5176 or (858) 384-5517, and using pin number 1687222.

About Guided Therapeutics
Guided Therapeutics, Inc. (OTCBB & OTCQB: GTHP) is developing a rapid and painless testing platform for the early detection of disease based on its patented biophotonic technology that utilizes light to detect disease at the cellular level.  The company’s first planned product is the LuViva™ Advance Cervical Scan, a non-invasive device used to detect cervical disease instantly and at the point of care.  In a multi-center clinical trial, with women at risk for cervical disease, the technology was able to detect cervical cancer up to two years earlier than conventional modalities, according to published reports. Guided Therapeutics has also entered into a partnership with Konica Minolta Opto to develop a non-invasive test for Barrett’s Esophagus using the technology platform. For more information, visit: www.guidedinc.com.
 
The Guided Therapeutics LuViva Advanced Cervical Scan is an investigational device and is limited by federal law to investigational use.
 
The LuViva mark, LuViva and wave logo, and "Early detection, better outcomes" are trademarks owned by Guided Therapeutics, Inc.
 
“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995. A number of the matters and subject areas discussed in this news release that are not historical or current facts deal with potential future circumstances and developments. The discussion of such matters and subject areas is qualified by the inherent risks and uncertainties surrounding future expectations generally and also may materially differ from Guided Therapeutics’ actual future experience involving any of or more of such matters and subject areas. Such risks and uncertainties include: the early stage of products in development, the uncertainty of market acceptance of products, the uncertainty of development or effectiveness of distribution channels, the intense competition in the medical device industry, the uncertainty of capital to develop products, the uncertainty of regulatory approval of products, dependence on licensed intellectual property, as well as those that are more fully described from time to time under the heading “Risk Factors” in Guided Therapeutics’ reports filed with the SEC, including Guided Therapeutics’ Annual Report on Form 10-K for the fiscal year ended December 31, 2010, and subsequent quarterly reports.
 
 
###MORE###
 
 
 

 
 
 
Guided Therapeutics – 1Q 2011
May 16, 2011
Page 3
 

 
GUIDED THERAPEUTICS, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
FOR THE THREE MONTHS ENDED March 31, 2011 AND 2010
(In Thousands, Except Per Share Data)

     
   
 Three Months Ended
March 31,
 
In Thousands except per share data
 
2011
   
2010
 
Revenue
    767       821  
                 
Expenses
               
Research & Development
    696       407  
Sales and Marketing
    49       34  
Selling, General & Administration
    762       570  
Total Operating Expense
    1,507       1,011  
                 
Operating Loss
    (740 )     (190 )
                 
Interest & Other Income (expense)
    14       (1,275 )
Net Loss
    (726 )     (1,465 )
Preferred Stock Dividends
    -       (1,700 )
Net Loss Attributable to Common Stockholders
    (726 )     (3,165 )
                 
Basic and Diluted Net Loss per Share
  $ (0.02 )   $ (0.15 )
 
               
Basic and Diluted
Weighted Average Shares Outstanding
    47,851       21,400  

 
Selected Balance Sheet Data (Unaudited)
 
   
March 31, 2011
   
December 31, 2010
 
Cash & Cash Equivalents
    2,307       3,268  
Working Capital
    167       612  
Total Assets
    3,137       3,919  
Accumulated Deficit
    (79,171 )     (78,515 )
Stockholders’ Equity
    777       1,117  

###END###
 
 
 
 

 
EX-99.2 3 ex99two.htm TRANSCRIPT ex99two.htm
 
 


1
1Q2011 Conference Call Script
May 17 – 11:00 a.m.
 
Opening – Alison Ziegler
 
 
Good morning and welcome to the Guided Therapeutics conference call and webcast to discuss first quarter 2011 results.
 
For today's call we have: Guided Therapeutics CEO and President Dr. Mark L. Faupel and company controller Charles Rufai (Roof-eye) Certified Public Accountant.
 
During this call the Company will be making forward-looking statements.  These statements can obviously differ from actual results, so relying on them is subject to risk. Factors that could cause forward-looking statements in this call to differ materially from actual results are discussed in the company's Form 10-K for the year ended December 31, 2010, and any subsequent filings with the Securities and Exchange Commission.
 
So at this time I will turn the conference call over to Dr. Faupel.
 
 
 
 

 
 
2
Welcome – MLF
 
Thank you, Alison and welcome everyone.
 
Since we last spoke we believe that we have continued toward the goals we outlined on our last call, with the main focus on bringing our cervical disease product to market.
 
We have just wrapped up two major medical conferences, Eurogin in Europe and ACOG in the U.S., where we unveiled our new LuViva branding and the updated cart design for the cervical product.
 
The new design further reduces size and improves upon the form and function.  It does not involve any of the fundamental internal workings of the device.
 
We believe that both the new name and final design were well received by the targeted audiences of physicians both in the US and overseas and by international distributor candidates.  There was a steady stream of doctors and industry representatives at both shows. We held two marketing focus groups with European doctors at EUROGIN. Two of our principal investigators from the FDA clinical trial presented results from the study at each of the two conferences. I personally attended the presentation in Europe where there were about 80 to 100 people in attendance. Good questions were asked after both presentations, indicating to us that there is a growing level of anticipation for the product.
 
The LuViva is based on our biophotonic platform technology that uses light and spectroscopy to scan living tissue for the markers of pre-cancer.
 
As you know, the technology is currently under U.S. Food and Drug Administration premarket approval review.  Just last month, we met with FDA and came away from the meeting with what we believe is a clearly defined path to a panel review meeting and guidance on answering the agency questions regarding our application that we received at the end of March.  We also successfully completed an FDA audit of our clinical trial records, bringing to four the number of successfully completed audits in connection with the PMA application.
 
 
 
 
 

 
 
3
 
We continue to remain comfortable with our forecast of a late 2011 or early 2012 product launch, assuming, of course, we receive regulatory approvals later this year.
 
As a reminder, our business model for the cervical product is for the sale or lease of the device plus a single-use disposable patient interface that has margins in the 90 percent range.  We expect the device itself will be priced at less than 20,000 dollars with the disposable priced around 30 to 40 dollars.  We are planning on a 10 person sales force in the U.S. that will initially focus on early adopters in the larger population centers.  We plan to ramp up our sales force during 2012.  In the U.S. alone 5.5 to 6 million women are called back after a Pap test for follow up and there are about 30,000 potential GYN office and institutional sales sites in the U.S.  The market internationally is expected to be larger than the U.S. and our marketing plan calls for country specific or regional distributors.
 
Pause
 
Now I’d like to discuss our pipeline product for Barrett’s Esophagus, which we are co-developing with Konica Minolta. As we reported earlier this month, Konica Minolta has renewed its option to license the technology for another year. This agreement is expected to bring in about 2.4 million dollars in fees and payments for development work over the course of the year.  950 thousand dollars was received in April.
 
 
 
 

 
 
4
 
 
We recently completed building our new Barrett’s prototype devices and are holding clinical investigator meetings today in anticipation of beginning a human feasibility study  this summer.  The feasibility study is designed to give us information about our current design and some preliminary information on how well the technology identifies diseased tissue.
 
We have two clinics in the Atlanta area where we will conduct the small scale study with 30 to 40 subjects, which should take 60 to 90 days to enroll, depending on availability of qualified subjects. Initial results could be available as early as the 4th quarter.
 
This technology is targeting a U.S. population of about three million people diagnosed with Barrett’s Esophagus who undergo monitoring every one or two years and an additional 30 million people who may be at risk.
 
The business model for the product would be similar to our cervical product with a relatively low cost device as compared to other equipment in a gastroenterologist’s office and single, high margin, patient use disposable.
 
We are also assisting Biofield Corporation, a company that has a non-invasive breast cancer detection technology, with engineering and manufacturing.  We have experience with the technology – which is unrelated to our biophotonic technology - and will use existing engineering and manufacturing resources that might have otherwise been idle waiting for the Barrett’s product to move from R&D and into engineering.  We received an initial payment of 250 thousand dollars and expect to receive additional payments throughout 2011.
 
 
 
 

 
 
5
 
PAUSE
 
Now let’s move on to our financial results. Here is controller Charles Rufai, Charles….
 
Thank you Mark.
 
Total revenue for the 1st quarter of 2011 was about 767 thousand dollars, compared to about 821 thousand dollars in 1st quarter of 2010. The majority of revenue came from our collaboration with Konica Minolta.
 
The net loss available to stockholders for the 1st quarter was about 726 thousand dollars, or 0.02 cents per share, compared to a loss of about 3.2 million dollars, or 0.15 cents per share, in the 1st quarter of the 2010.  In the three months ended March 31, 2010, the Company incurred about $1.2 million in interest expense on Notes Payable, as well as about $1.7 million in dividend expenses on Series A preferred stock. The Notes and the preferred stock were converted into common shares in 2010.
 
Stockholders’ equity at the end of the first quarter of 2011 was 777 thousand dollars compared to about 1.1 million dollars at the end of our fiscal year ended December 31, 2010. The change was mostly due to the net loss of about 726 thousand dollars, offset by an increase of 385 thousand dollars in additional paid in capital, for shares issued within the quarter.
 
 
 
 

 
 
6
 
 
Cash on hand at the end of the 1st quarter was about 2.3 million dollars. Working capital at the end of the 1st quarter was about 167 thousand dollars.
 
Based on where we are today, we expect current cash to carry us through the fourth quarter of 2011.
 
Our current monthly burn is about 400 thousand dollars.  Offsetting this we anticipate about 2.4 million dollars from Konica Minolta, as well as additional federal grants which could bring in an about 750 thousand dollars.  We also have 28.9 million warrants outstanding which are in the money at the conversion price of 65 cents.  So far in 2011 they have brought in an about 179 thousand dollars for a total of about 612 thousand dollars. The warrant pool has the potential to bring in a total of 18.8 million dollars, if all were converted.
 
We do have plans to seek additional financing as we begin to ramp up our marketing and production in advance of what we hope will be a positive decision from the FDA later in the year.
 
I’ll now turn the call back over to Mark
 
PAUSE
 
Thank you Charles.
 
In closing, I want to reiterate our goals for the remainder of 2011:
 
·  
Obtain FDA approval for our LuViva cervical product
 
·  
Finalize the CE mark process for access to the European market
 
 
 
 
 

 
7
 
 
·  
Announce agreements for distribution for major Asian, South American and European countries
 
·  
Set up our manufacturing facility and complete outside vendor selection
 
·  
Move our Barrett’s technology into the clinic and establish feasibility
 
·  
Expand our non-invasive cancer detection pipeline by identifying our third product extension
 
·  
Raise additional capital for expansion and product launch
 
·  
And pave the way to move our shares to a national stock market such as NASDAQ
 
We look forward to successfully meeting these goals and creating additional value for our shareholders, customers and employees.
 
Thank you for your time and I’ll now turn the call over to the operator for your questions.
 
 
 
 
 
 
 
 

 
 
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