-----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, O1IOVSrssqdma06v56O2hRqWQhrjYXJTlIKVpCq2FgqTsuS9lHltornT3yXfHR98 O+jW8clitC2DPWd0cXY3QQ== 0000924515-06-000016.txt : 20060523 0000924515-06-000016.hdr.sgml : 20060523 20060523155442 ACCESSION NUMBER: 0000924515-06-000016 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20060523 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060523 DATE AS OF CHANGE: 20060523 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SPECTRX 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: 06861475 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 8-K 1 sp8k052306.htm CURRENT REPORT SPECTRX, INC.
Table of Contents

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 23, 2006 (May 22, 2006)

SPECTRX, 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.)
     

4955 Avalon Ridge Pkwy, Suite 300
Norcross, Georgia

(Address of Principal Executive Offices)

 

30071
(Zip Code)

Registrant's Telephone Number, Including Area Code:     (770) 242-8723


(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 :

 

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 9.01. FINANCIAL STATEMENTS AND EXHIBITS.
SIGNATURES
EXHIBIT INDEX
Exhibit 99.1 (Earnings) Press Release, dated May 22, 2006.
Exhibit 99.2 Conference Call Script, dated May 23, 2006.


Table of Contents

Item 2.02.          Results of Operations and Financial Condition.

     

On May 22, 2006, the registrant publicly released it's financial results for the first quarter 2006, 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. In addition, the script for the conference call, which was held on May 23, 2006, is furnished as Exhibit 99.2 hereto and which information is incorporated herein by reference.
 


Table of Contents

 

Item 9.01.         Financial Statements and Exhibits.

                    (c)      Exhibits.

     The following exhibits are filed or furnished with this report:

     
Exhibit No.   Exhibit Description

 
99.1   (Earnings) Press Release, dated May 22, 2006
99.2   Conference Call Script, dated May 23, 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 thereunto duly authorized.

         
    SPECTRX, INC.
 
         
 
   
/s/ MARK A. SAMUELS

    By:   Mark A. Samuels
        CEO & CFO
 
         
 
Date: May 23, 2006.        

 


Table of Contents

EXHIBIT INDEX

     
Exhibit No.   Exhibit Description

 
99.1   (Earnings) Press Release, dated May 22, 2006
99.2   Conference Call Script, dated May 23, 2006

 

EX-99.1 2 sp8k052306ex991.htm EXHIBIT 99.1 SpectRx Inc

 

SpectRx, Inc. (770) 242-8723

Bill Wells - Media

 

SpectRx Reports First Quarter 2006 Results

Current Highlights:

  • Pre-production non-invasive cervical cancer detection device, along with single-patient-use disposables, undergoing clinical evaluation at a major hospital
  • Enrollment in FDA pivotal clinical trial of cervical cancer detection device surpasses 1,000 subjects
  • Availability of SimpleChoice® product improving
  • Contract negotiations underway with a potential continuous glucose monitoring partner

Norcross, GA (May 22, 2006) -- SpectRx, Inc. (OTCBB: SPRX) today announced its operating results for the first quarter of 2006.

Revenue for the first quarter of 2006 was $127,000 compared to revenue of $369,000 in the first quarter of 2005. The decrease in revenue was primarily due to an expected decrease in sales of SimpleChoice® products.

The net loss attributable to common stockholders for the first quarter of 2006 was $1.3 million, compared to a loss of $1.4 million in the comparable quarter of 2005. The net loss attributable to common stockholders was $0.11 per share in the first quarter of 2006, compared to a loss of $0.12 per share in the first quarter of 2005.

"We have reached a significant milestone in the FDA pivotal trial for our non-invasive cervical cancer detection device and our first pre-production, cost-reduced prototype is undergoing clinical evaluation," said Mark A. Samuels, SpectRx, Inc. chairman and chief executive officer. "We have also seen improvement in our ability to manufacture SimpleChoice insulin pump products. We plan to build upon these achievements in the coming quarters."

Diabetes Business Update -

"As we announced in our last quarterly results news release, we have undertaken a wide ranging review and rework of our SimpleChoice manufacturing systems and processes, and we are beginning to see a marked improvement in the availability of products," said Bill Arthur, SpectRx, Inc. president and chief operating officer. "We believe that we will begin to see an increase in product sales in the coming quarters now that we have, what we believe to be, a consistent supply of products."

"Our efforts to secure a partner for our continuous glucose monitoring technology continue with our entry into contract negotiations with one potential partner and ongoing discussions with a second," Mr. Arthur said. "We expect to have a preliminary agreement in place soon that would allow for joint research and development aimed at developing glucose monitoring products."

Cancer Detection Business Update -

"Subject enrollment for the pivotal FDA clinical trial of our non-invasive cervical cancer detection device has surpassed 1,000 women," said Mark Faupel, Ph.D., SpectRx chief technical officer and president of Guided Therapeutics, Inc., the SpectRx subsidiary formed to commercialize the non-invasive cervical cancer detection device. "This is an important milestone for the program. We also have put into the clinic our first pre-production cervical cancer detection device with our patented single-use, self calibrating disposable. Feedback from the physicians using the new system has been very positive."

SpectRx management will hold a conference call to discuss first quarter 2006 results on Tuesday, May 23, 2006 at 11 a.m. eastern time. To access the call via telephone, call 800-889-0817 or visit www.ccbn.com or www.fulldisclosure.com for access via the Internet.

About SpectRx, Inc.

SpectRx, Inc. (OTCBB: SPRX) is a diabetes management company developing and providing innovative solutions for insulin delivery and glucose monitoring. SpectRx markets the SimpleChoice® line of innovative diabetes management products, which include insulin pump disposable supplies. SpectRx also plans to develop a consumer device for continuous glucose monitoring. The company is commercializing its non-invasive cervical cancer detection technology through its subsidiary Guided Therapeutics, Inc., which SpectRx intends to separately finance. For more information, visit SpectRx's web sites at spectrx.com, mysimplechoice.com and guidedtherapeutics.com.

 

The Guided Therapeutics device is an investigational device and is limited by federal law to investigational use.

"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 SpectRx's 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 ti me to time under the heading "Risk Factors" in SpectRx's reports filed with the SEC, including SpectRx's Annual Report on Form 10-KSB for the fiscal year ended December 31, 2005, as amended, and subsequent quarterly reports.

 

SpectRx, Inc. and Subsidiaries

Consolidated Condensed Statement of Operations (Unaudited)

 

 

Three Months Ended

March 31

In Thousands except per share data

2006

2005

Revenue

$127

$369

Cost of Sales

198

393

Gross profit (loss)

(71)

(24)

Expenses

Research & Development

523

664

Selling, General & Administration

457

513

Total Operating Expense

980

1,177

Operating Loss

(1,051)

(1,201)

Interest & Other Income (expense)

(141)

(93)

Net Loss

(1,192)

(1,294)

Preferred Stock Dividends

(92)

(90)

Net Loss Attributable to Common Stockholders

($1,284)

($1,384)

Basic and Diluted Net Loss per Share

($0.11)

($0.12)

Basic and Diluted Weighted Average Shares Outstanding

11,738

11,557

Selected Balance Sheet Data (Unaudited)

 

March 31, 2006

December 31, 2005

Cash Equivalents

912

313

Working Capital Deficit

(7,351)

(6,128)

Total Assets

2,254

1,750

Accumulated Deficit

(63,858)

(62,666)

Stockholders' Equity (Deficit)

(7,428)

(6,167)

Redeemable Stock in default

5,227

5,113

###END###

 

EX-99.2 3 sp8k052306ex992.htm EXHIBIT 99.2 1Q2006 Conference Call Script

1Q2006 Conference Call Script

May 22 - 11:00 a.m.

Opening - Bill Wells

Good morning and welcome to the SpectRx conference call and webcast to discuss first quarter 2006 results.

For today's call we have: SpectRx Chairman and CEO Mark Samuels....... President and Chief Operating Officer Bill Arthur....., Dr. Mark Faupel, president and chief operating officer of subsidiary Guided Therapeutics and Bobby Noorani, Controller & Principal Accounting Officer.

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-KSB, as amended, for the year ended December 31, 2005, and any subsequent filings with the Securities and Exchange Commission.

So at this time I will turn the conference call over to Mark Samuels --- please go ahead Mark.

 

Welcome - MAS

Thank you Bill. I want to welcome everyone to our first quarter 2006 conference call.

I am very pleased to announce progress in a number of areas important to the company.

Turning first to our Diabetes business, we made a number of changes in our SimpleChoice operations and manufacturing process in the first quarter that we believe have significantly improved our ability to maintain a reliable supply of SimpleChoice products. I believe that the temporary disruption in manufacturing experienced in the first quarter has led to great improvement in our ability to meet customer demand in the future.

Also in our diabetes business, I am very pleased to announce that we are making substantial progress in our efforts to secure a viable strategic partner for our continuous glucose monitoring technology. We are currently in various stages of contract discussions with two potential partners. We expect to have a preliminary agreement in place soon that could potentially lead to licensing or joint research and development aimed at developing glucose monitoring products. We were also recently granted two additional patents covering various areas using our continuous monitoring technology. These patents further strengthen our intellectual property position in interstitial fluid monitoring.... and brings the total to 17 U.S. patents protecting this area.

In our cancer detection business, we reached a significant milestone in the FDA pivotal trial of our non-invasive cervical cancer detection device and have placed our first pre-production, cost-reduced prototype in a major hospital for testing. This new prototype employs our patented, single-patient use and calibration disposable, a key part of our cancer detection business model.

In order to continue to support our ongoing operations, we secured 1.9 million dollars in debt financing for the company during the quarter. We plan to raise additional debt or asset based financing as needed to cover short term cash needs as we work to rebuild SimpleChoice sales and obtain separate financing for our cancer detection activities. At the appropriate time, we plan to refinance the company.

As you can see we have made considerable progress, while carefully managing our resources.

Now to go into more detail about our SimpleChoice diabetes business, I'll turn the call over to President and COO Bill Arthur, Bill.

Thanks Mark.

To expand on what Mark said, we announced in our last quarterly call that we had undertaken a wide ranging review of our SimpleChoice manufacturing processes. As a result of the review and refinements implemented, we are today seeing a significant improvement in the availability of products. As expected, sales for the first quarter were significantly reduced. However, now that we have a more steady supply of product, we believe that we will begin to see an increase in product sales in the coming quarters.

It is also clear that the insulin pump distribution market place has and is undergoing significant changes. We believe that these market dynamics offer both challenges and opportunities for our SimpleChoice business. The challenges include fewer potential outlets for products. The opportunities include a more favorable potential to form partnerships with these entities. We also believe that this new market paradigm offers an improved opportunity for a strategic partnership that would provide the resources needed to commercialize the SimpleChoice patch and provide new outlets for our products.

I'd now like to turn the call back over to Mark.

Thank you Bill. Now I'd like to turn the call over to our Controller & Principal Accounting Officer Bobby Noorani to update our financials.

Thank you Mark.

Total revenue for the 1st quarter of 2006 was $127,000, compared to $369,000 in the 1st quarter of 2005.

SimpleChoice sales for the quarter totaled $67,000 as compared to $326,000 during the 1st quarter of 2005. The decrease was caused primarily by a temporary disruption in the company's manufacturing as previously discussed.

Our quarterly operating results illustrate our continuing management of expenses versus the prior year. In the first quarter of 2006 we had a decrease of $197,000, or 17 percent, in overall expenses when compared to the same quarter of 2005, primarily due to a reduction in R&D expenses, which were down by $141,000.

Operating income for the quarter was a loss of $1.1 million compared to a loss of $1.2 million for the same quarter in 2005.

The net loss available to stockholders for the 1st quarter of 2006 was $1.3 million, or 11 cents per share, compared to a loss of $1.4 million, or 12 cents per share, in the same quarter of 2005.

Cash on hand at the end of the 1st quarter was approximately $912,000. Working capital at the end of the 1st quarter was approximately a negative $7.4 million. The working capital deficit includes the previously reported 5.2 million dollar default on Abbott redeemable convertible preferred stock.

Stockholders' equity went from a deficit of $62.7 million at the end of the 1st quarter of 2005, compared to a deficit of $63.9 million at the end of the same quarter in 2006. $3.2 million of this deficit was due to the write off of SimpleChoice intangibles in 2004.

In the 1st quarter of 2006, we reported that the company raised 1.9 million dollars in debt financing.

I'll now turn the call back over to Mark Samuels........ Mark.

Thank you Bobby.

As part of our plan to focus SpectRx on diabetes management, we have created Guided Therapeutics, a subsidiary, to commercialize our non-invasive cervical cancer detection technology.

Now here to update you on our non-invasive cervical cancer detection business is Doctor Mark Faupel, president and COO of Guided Therapeutics.

Thanks Mark.

We continue make significant and measurable progress in the development of our non-invasive cervical cancer detection device. On the regulatory side, enrollment in the pivotal FDA clinical trial continues as expected, and we have now tested more than 1,000 women. Also, since our last call, we have successfully installed the first pre-production device in a major hospital clinic and are testing patients. This new prototype features for the first time our patented, single-patient-use disposable element. So far, feedback about the new device and disposables from the doctors has been very positive.

Additionally, two revised manuscripts detailing positive clinical study results of previous devices have been accepted for publication in the Journal of Lower Genital Tract Disease, which is the flagship journal of the American Society of Colposcopy and Cervical Pathology.

Funding for our ongoing clinical trials and commercialization work has been supported in part by grants from the National Cancer Institute and the Georgia Research Alliance.

I want to take a moment now and address the recent news about the human papilloma virus, or HPV, vaccine and its potential affect on the cervical cancer screening and detection market.

Late last week an FDA panel of outside experts recommended that the agency approve the first vaccine for HPV. HPV is believed to be the leading cause of cervical cancer. This is encouraging news and we welcome advances in prevention.

The impact of the vaccine on the cervical cancer market will not begin to be felt perhaps for another 20 to 30 years - - "at least a generation away," according to the American College of Obstetricians and Gynecologists. This new vaccine targets two of the strains of HPV that are believed to cause cervical cancer. Vaccines covering additional strains will be needed before HPV is eliminated as a cause of cervical cancer. Finally, the expected cost of 300 to 500 dollars and a three-shot, six-month dosing regimen are expected to slow adoption.

We believe, along with others, that the vaccine is a good start and very positive, however the need for fast, cost-effective detection of cervical cancer will be with us for the next few, if not several, decades.

As you may recall, our rapid, point-of-care, non-invasive test, unlike Pap smears and HPV testing, does not require a tissue sample or the delay of laboratory analysis. To date more than 2,000 women have been tested with prototype devices, which have consistently provided better results than other tests.

The product is being designed as a low-cost device with a single-patient-use calibration disposable. Additionally, we believe that the test will be immediately reimbursable under existing CPT codes.

I'll now turn the call back over to Mark Samuels......

Thank you Mark.

That is exciting news from our Guided Therapeutics team. We believe that our non-invasive cervical cancer detection device represents a significant opportunity for the company.

We are also pleased with the progress made by our SimpleChoice team in improving the product supply chain. We felt it was important to take a short-term reduction in revenue in order to be better prepared for long-term growth in that business. We have seen a significant improvement in the availability of product, and believe that over the coming quarters, we will begin to see increases in revenue. This process can be accelerated if we are successful in establishing meaningful partnerships with one or more of the major players in the marketplace.

We are also encouraged by the level of interest in our continuous glucose monitoring program. Our approach offers the advantage of not requiring implantation of the sensor under the skin and when compared one to one with a commercially available implantable system, more than half the people tested preferred our device.

In closing, we believe in our prospects for success and are following a plan to increase shareholder value. Our plan for success is:

  • to increase the value of SimpleChoice by building sales and creating partnerships,

  • to separately finance our cervical cancer detection business,

  • to commercialize a product through a new partnership for continuous glucose monitoring

  • to recapitalize the company at the appropriate time, and seek a relisting on NASDAQ

  • We look forward to updating you as we continue to execute on our plans.

    Thank you operator and thank you for participating in our first quarter 2006 conference call.

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    -----END PRIVACY-ENHANCED MESSAGE-----