-----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, CP/huw41la3qpo08QcjH+ndaw0eXCezHjKG/b27J7un+Eat/dfCXVp8QNVvs7xNI ohNwW8tpQFM56CdOFVWZlg== 0000924515-05-000017.txt : 20050812 0000924515-05-000017.hdr.sgml : 20050812 20050812155347 ACCESSION NUMBER: 0000924515-05-000017 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20050812 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050812 DATE AS OF CHANGE: 20050812 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: 051021617 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 sp8k0812052.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): August 12, 2005 (August 11, 2005)

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)

 


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 August 11, 2005.
Exhibit 99.2 Conference Call Script, dated August 12, 2005.


Table of Contents

Item 2.02.          Results of Operations and Financial Condition.

     

On August 11, 2005 , the registrant publicly released the registrant's financial results for the second quarter of 2005 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 August 12, 2005 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 August 11, 2005
99.2   Conference Call Script, dated August 12, 2005

 


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: August 12, 2005.        

 


Table of Contents

EXHIBIT INDEX

     
Exhibit No.   Exhibit Description

 
99.1   (Earnings) Press Release, dated August 11, 2005
99.2   Conference Call Script, dated August 12, 2005

 

EX-99.1 2 sppr081105.htm EXHIBIT 99.1 For Immediate Release Contacts: Bill Wells - Media

SpectRx, Inc. (770) 242-8723

Bill Wells - Media

 

 

SpectRx, Inc. Reports Second Quarter 2005 Results

Current Highlights -

SimpleChoice®twist 90-degree insulin pump infusion set begins market introduction this week

FDA grants 510K clearance to SimpleChoice brand Medtronic Paradigm®-compatible insulin pump reservoir

Patient testing one-third complete for non-invasive cervical cancer detection pivotal FDA clinical trial

Norcross, GA (August 11, 2005) -- SpectRx, Inc. (OTCBB: SPRX) today announced operating results for the quarter and six months ended June 30, 2005.

Revenue for the three months ended June 30, 2005, was $269,000, versus $272,000 for the same period last year. The reduction in revenue was primarily due to a short-term limited availability for sale of certain SimpleChoice products.

During the second quarter, the company received a $1.1 million payment against future earn outs from the sale of the BiliChek product line. A $275,000 payment to settle an intellectual property dispute involving the BiliChek was made by Respironics on behalf of SpectRx. The settlement payment is to be off set by future earn outs.

For the six months ended June 30, 2005, revenue was $638,000, versus $397,000 for the same period last year. The increase in revenue for the six months reflects a 71% increase in SimpleChoice revenue.

The net loss available to common stockholders for the second quarter of 2005 was $1.4 million, or $0.12 per share, compared with a net loss available to common stockholders of $1.8 million, or $0.16 per share, in the comparable quarter of 2004. For the first six months of this year, the net loss available to common stockholders was $2.8 million, or $0.24 per share compared with a net loss available to common stockholders of $9.4 million, or $0.82 per share, in the first half of 2004.

"We are very excited about the introduction of our new SimpleChoice twist 90-degree insulin pump infusion set product this week," said Mark A. Samuels, chairman and chief executive officer of SpectRx, Inc. "We believe the addition of this new product will provide us with access to the $300 million 90-degree set market segment and enhance our product line. While we are pleased with the introduction of the new product and recent FDA clearance, we still have significant challenges ahead as we execute on our plans to increase product revenue and raise working capital as we move SimpleChoice forward."

Diabetes Business Update -

"The expansion of our product line with the addition of our 90 degree twist should help remove a significant barrier to the adoption of our products in the marketplace," said Bill Arthur, president and chief operating officer of SpectRx, Inc. "We are looking forward to beginning the twist product introduction with sampling and initial shipments to key distributors this month and then expect to build sales as manufacturing capability increases over the next few months. We are debuting the new product at the American Association of Diabetes Educators meeting this week."

"In diabetes monitoring, we are continuing our efforts to seek a partner for our continuous glucose monitoring product," Mr. Arthur said.

Cancer Detection Business Update -

"To date we have enrolled almost 500 patients at four clinical sites in the ongoing pivotal FDA trial for our non-invasive cervical cancer detection device," said Mark Faupel, president and chief operating officer of Guided Therapeutics, Inc., the SpectRx subsidiary company formed to commercialize the non-invasive cervical cancer device. "A device has been installed and training has begun at a fifth site which we expect to be operational within the next few weeks."

SpectRx management will hold a conference call to discuss second quarter 2005 results on Friday, August 12, 2005 at 11 a.m. EDT. To access the call via telephone, call 800-889-0817 or visit www.ccbn.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 cancer detection technology through subsidiary company Guided Therapeutics, Inc., which SpectRx intends to separately finance with private funds. For more information, visit SpectRx's web sites at www.spectrx.com, www.mysimplechoice.com and www.guidedtherapeutics.com.

Trademarks are owned by their respective companies.

The Guided Therapeutics device is an investigational device and 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 in SpectRx's reports under the heading "Risk Factors" filed with the SEC, including SpectRx's Annual Report on Forms 10-K for the fiscal year ended December 31, 2004 and subsequent quarterly reports.

Financial Tables

SpectRx, Inc & Subsidiaries
Condensed Statement of Operations (Unaudited)
Three Months Ended Six Months Ended

June 30 June 30

In Thousands except per share data

2005

2004

2005

2004

Revenue

$269

$272

$638

$397

Cost of Sales

318

241

711

527

Gross Profit (Loss)

(49)

31

(73)

(130)

Expenses

Research & Development

344

978

1,008

1,917

Selling, General & Administrative

535

788

1,048

1,276

Expense on Sale of BiliChek Product Line

275

0

275

0

Total Operating Expenses

1,154

1,766

2,331

3,193

Operating Loss

(1,203)

(1,735)

(2,404)

(3,323)

Interest & Other Income (Expense)

(44)

(16)

(84)

(919)

Net Loss

(1,247)

(1,751)

(2,488)

(4,242)

Preferred Stock Dividends

(145)

(68)

(288)

(141)

Deemed Dividend on Preferred Stock

0

0

0

(4,970)

Net Loss Attributable to Common Stockholders

$(1,392)

$(1,819)

$(2,776)

$(9,353)

Basic & Diluted Net Loss per Share

($0.12)

($0.16)

($0.24)

($0.82)

Basic & Diluted Weighted Average Shares Outstanding

11,579


11,386

11,568

11,379

Selected Balance Sheet Data (Unaudited)

 

June 30, 2005

December 31, 2004

Cash & Cash Equivalents

$1,020

247

Working Capital

(3,533)

(2,436)

Total Assets

2,444

2,805

Accumulated Deficit

(63,584)

(60,808)

Stockholders' Equity (Deficit)

(6,439)

(3,695)

Redeemable Preferred Stock, Long-term Portion

1,740

1,634

 

 

 

 

 

 

 

###End###

 

EX-99.2 3 spcc081205.htm EXHIBIT 99.2 1Q2003 Conference Call Script

2Q2005 Conference Call Script

August 12, 2005

11 a.m.

Opening - Bill Wells

Good morning and thank you for participating in the SpectRx conference call and webcast to discuss second quarter 2005 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 for the year ending December 31, 2004, 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 second quarter 2005 conference call.

I am pleased to report the market introduction this week of the SimpleChoice twist - our next generation 90-degree insulin pump infusion set with full 360-degree rotation. The launch of the twist opens up the 300 million dollar 90-degree market segment to us, and greatly improves our ability to attract new distributors and customers. We are also pleased to announce the receipt of FDA 510K clearance for our new Medtronic paradigm-compatible insulin reservoir, which will also help increase sales, once it is available.

The launch of the Twist is a major milestone for our company. Although we have been very disappointed with the delays, we believe that our expertise in insulin set design and manufacture has increased substantially over the past year as we have worked to launch this highly innovative infusion set. SimpleChoice has now completed the design and engineering of both a 90-degree and a 30-degree infusion set, launched a reservoir compatible with a leading infusion pump and received FDA clearance for a second reservoir. We still have significant challenges ahead as we establish a profitable business in this highly competitive marketplace, however our expertise is now a platform upon which we believe we can build a strong future with additional planned innovative products.

 

Pause

We are increasingly excited by the progress also being made in the development of our non-invasive cervical cancer detection device. Since the last call, we have significantly increased enrollment, as well as added another clinical site in the ongoing FDA pivotal trial. This opportunity continues to grow and we expect to retain a banker in the near future to help us separately finance this opportunity.

Pause

During the quarter we were pleased to receive a one-point-one million-dollar payment from Respironics as a payment against future earn outs related to the sale of the BiliChek product line. This one point one million in cash is confirmation that the BiliChek product line continues to do well at Respiroincs. Meanwhile, we are continuing manage our cash very carefully, and while we are pleased with the introduction of the new product and recent FDA clearance, we still have a lot of work to do as we execute on our plans to increase product revenue. Expected increases in working capital associated with the introduction of the Twist, the expected growth the other products and our normal operating expenses will require us to raise additional cash as we move SimpleChoice forward. As we have previously indicated, we currently plan to satisfy our SimpleChoice cash needs through the end of the year using asset based financing.

Pause

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.

As Mark mentioned earlier, we are introducing the SimpleChoice twist this week. This launch coincides with the American Association of Diabetes Educators annual meeting, which is an excellent vehicle for introducing products.

The expansion of our product line, due to the addition of our 90-degree twist, should help remove a significant barrier to the adoption of our products in the marketplace. We are looking forward to beginning the twist product introduction with sampling and initial shipments to key distributors this month and then continue to build sales as manufacturing capability increases over the next few months.

Having the twist on the market does several things for us. It provides access to the largest segment of the pump supply market - - the $300 million 90-degree market. It also opens up new distribution channels, previously unavailable because we did not have a 90-degree automatically insertable set.

In pre-launch user studies, patients are most pleased with the comfort of the design. The 360-degree rotation and catheter design should contribute to a more pleasant pump wearing experience. This next-generation product is designed to be more like a part of the body, and less like a part of the pump. We believe that the novel attraction of the rotation will compel people to try the set and the comfort of the catheter will keep them coming back.

The 90-degree set launch combined with the just received 510K clearance granted by the FDA for our Paradigm-compatible insulin reservoir is good news for the company and I am excited about getting into the market and making positive things happen for SimpleChoice.

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

 

Thanks Bill.

To bring us up to date on our financial results, I'll turn the call over to Controller & Principal Accounting Officer Bobby Noorani.

 

Thank you Mark.

In general, we have had a significant decrease in overall expenses, due primarily to an increase in reimbursements from the National Cancer Institute.

SimpleChoice sales for the 2nd quarter totaled $134,000 as compared to $192,000 during the 2nd quarter of 2004 and $326,000 in the 1st quarter of 2005. Year-to-date simple choice sales totaled $460,000 compared to 270,000 for the 2004 period. The decrease in SimpleChoice revenue in the second quarter of 2005 was due to limited product availability in May and June.

The total revenue for the 2nd quarter of 2005 was $269,000, compared to $274,000 in the 2nd quarter of 2004. Total revenue year-to-date for 2005 was $638,000 compared to $397,000 in 2004.

During the quarter we have recognized $275,000 of expense and have deferred the related $1.3 million of gain on the sale of the BiliChek product line, which we expect to recognize as gain in the fourth quarter of 2005.

Our quarterly operating results illustrate our continuing management of expenses versus prior year. Excluding the effect of the expense on the sale of BiliChek we had a decrease of $887,000, or 50%, in overall expenses for the quarter when compared to the same quarter of 2004, primarily due to a reduction in R&D expenses, which are down by $635,000 and also due to a $200,000 reduction in G&A expenses.

Operating loss for the quarter was $1.2 million compared to a loss of $1.7 million for the same quarter in 2004. Year-to-date operating loss was $2.4 million compared to a loss of $3.3 million in 2004.

The net loss attributable to stockholders for the 2nd quarter of 2005 was $1.4 million, compared to $1.8 million in the 2nd quarter of the previous year. Year-to-date the net loss attributable to stockholders for 2005 was $2.8 million compared to $9.4 million in 2004.

Comparison of net loss in 2005 to 2004 includes two significant items related to financing activities in 2004, which were:

$871,000 of non-cash interest expense due to the value of the warrants issued in conjunction with the bridge loans;

and,

the $5 million deemed dividend recognized in the 1st quarter of 2004.

Cash on hand at the end of the 2nd quarter was approximately $1.0 million. Working capital at the end of the 2nd quarter was approximately a negative $3.5 million.

Stockholders' equity decreased from a deficit of $3.7 million at the year-end 2004 to a deficit of $6.4 million at the end of the 2nd quarter of 2005. $3.2 million of this deficit was due to the write off of SimpleChoice intangibles in 2004.

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

Thank you Bobby.

As part of our plan to focus the public company on diabetes management, we have created a separate organization to commercialize our non-invasive cancer detection technology. We are currently financing this organization - - called Guided Therapeutics - through grants and contracts.

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

Thanks Mark.

As mentioned earlier, we are pleased with recent the progress made in the development of our non-invasive cervical cancer detection device.

We have enrolled almost 500 patients in our ongoing FDA pivotal clinical trials. That's out of about 1,500 patients we expect to enroll. Since our last conference call, we have added another clinical site to the trial - - the University of Arkansas in Little Rock, which is in training with the device. The other clinical sites are Parkland hospital in Dallas, Emory University/Grady hospital in Atlanta, the University of Miami and St. Francis Hospital in Hartford, which is affiliated with the University of Connecticut.

Meanwhile, we are moving forward with development of pre-production devices and disposables. These pre-production units and disposables will be used to complete the FDA pivotal clinical trial. We plan to have these beta devices and disposables completed by year's end and in the clinics after the first of the year.

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

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 1,400 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 is immediately reimbursable under existing CPT codes, and that the market opportunity for this product is approximately 1.3 billion dollars.

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

 

Thank you Mark.

Launching the 90-degree twist product, FDA clearance for the new reservoir and the progress being made in the cervical cancer detection program are all significant and positive events for the company. A key part of our plan over the coming months is to significantly increase product revenue and prove that our vision for SimpleChoice is viable.

Our plan for success is as follows:

to launch the 90-degree twist product and build SimpleChoice sales,

to continue to improve our supply chain in order to insure economical sources of high quality component and assemblies,

to complete the financing of our cervical cancer detection technology platform in order to provide a strong financial basis for market introduction,

to add additional products to the SimpleChoice line,

to recapitalize the company in 2006 as our sales model is proven and the value of our equity recovers, and:

to seek a relisting on NASDAQ sometime toward the end of 2006.

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

Thank you operator and thank you for participating in our second quarter 2005 conference call.

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