-----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, NhRtWW6J3oHxr3Wgq44iVqUWIgtf9QdmNKzM06u38aqegdXPks8XaSrqgFP8qZN3 XZ0Qpy40xZbPpdXKBvUhvw== 0000924515-05-000002.txt : 20050330 0000924515-05-000002.hdr.sgml : 20050330 20050330164617 ACCESSION NUMBER: 0000924515-05-000002 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20050330 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050330 DATE AS OF CHANGE: 20050330 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: 05714794 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 sp8k033005.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): March 30, 2005 (March 29, 2005)

SPECTRX, INC.
(Exact Name of Registrant as Specified in Its Charter)

         
Delaware
(State or Other Jurisdiction of Incorporation)
  0-22179
(Commission File Numbers)
  58-2029543
(I.R.S. Employer Identification Nos.)
     

4955 Avalon Ridge Pkwy, Suite 300
Norcross, Georgia

(Address of Principal Executive Offices)

 

30071
(Zip Code)

Registrants' 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 March 29, 2005.
Exhibit 99.2 Conference Call Script, dated March 30, 2005.


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Item 2.02.          Results of Operations and Financial Condition.

     

On March 29, 2005 , the registrant publicly released the registrant's financial results for the fourth quarter of 2004 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 March 30, 2005 is furnished as Exhibit 99.2 hereto and which information is incorporated herein by reference.
 


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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 March 29, 2005
99.2   Conference Call Script, dated March 30, 2005

 


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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/ WILLIAM D. ARTHUR, III

    By:   William D. Arthur, III
        President & Chief Operating Officer
 
         
 
Date: March 30, 2005.        

 


Table of Contents

EXHIBIT INDEX

     
Exhibit No.   Exhibit Description

 
99.1   (Earnings) Press Release, dated March 29, 2005
99.2   Conference Call Script, dated March 30, 2005

 

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SpectRx, Inc. (770) 242-8723

Bill Wells - Media

SpectRx Reports Fourth Quarter and Year-End 2004 Results

Current Highlights:

SimpleChoice® products launched in Europe

SimpleChoice® Q1 2005 revenue expected to double over Q4 2004

Interstitial fluid alcohol sensor contract increased by $739,000

FDA pivotal trial for non-invasive cervical cancer detection device adds third clinical site

Norcross, GA (March 29, 2005) -- SpectRx, Inc. (OTCBB: SPRX) today announced its unaudited operating results for the fourth quarter and year-end 2004.

Revenue for the fourth quarter of 2004 was $675,000, compared to revenue of $450,000 in the fourth quarter of 2003. Revenue for all of 2004 was $1.3 million compared to $1.6 million for all of 2003.

The net loss available to common stockholders for the fourth quarter of 2004 was ($146,000), or ($0.01) per basic and diluted share, compared to net income of $1.4 million, or $0.13 per basic and $0.12 per diluted share, in the comparable quarter of 2003. For the full year, the net loss attributable to common stockholders was ($11.3) million, or ($0.99) per basic and diluted share, compared to a net loss of ($2.9) million, or ($0.26) per basic and diluted share, in 2003. The ($11.3) million loss in 2004 includes a $5.0 million deemed dividend and $871,000 of interest expense related to the warrants issued in conjunction with the bridge loan in the first quarter of 2004.

"We continue to make gains in operating revenue while simultaneously lowering expenses," said Mark A. Samuels, SpectRx, Inc. chairman and chief executive officer. "I am especially excited about the increase in SimpleChoice revenue we have seen so far in 2005, despite our limited product line. I feel confident that once our 90-degree rotating infusion product is on the market, we will be able to make significant progress toward profitability. We are also very excited about the advancements being made in our non-invasive cervical cancer detection development program, which is steadily making progress toward completing the pivotal clinical trials needed to obtain Food and Drug Administration approval."

"We are also pleased to announce today a planned extension and $739,000 increase in funding in our contract with the National Institute on Alcohol Abuse and Alcoholism to develop a continuous alcohol sensor. This contract is part of our efforts to expand the capabilities of our interstitial fluid (ISF) sampling technology platform in a way that is complimentary to glucose monitoring. Meanwhile, efforts to find a partner for our ISF glucose monitoring technology are also continuing, with an increased focus on finding a technology collaborator with appropriate glucose assays," Mr. Samuels said.

Diabetes Business Update -

"We are now shipping our SimpleChoice insulin pump products to European distributors and are pleased with the initial sell through and re-orders so far," said Bill Arthur, SpectRx, Inc. president and chief operating officer.  "Partially as a result of European sales, we expect first quarter 2005 SimpleChoice revenue of approximately $300,000."

"We are currently debugging the assembly line for our new 90-degree rotating infusion set.  If all goes well, we expect that product on the market in the second quarter.  Now that the 90-degree set is close to market, we are beginning to shift R&D resources back to additional new products including the patch," Mr. Arthur said.

Cancer Detection Business Update -

"We now have three clinical sites up and running in the FDA pivotal clinical trial of our non-invasive cervical cancer detection technology," said Mark Faupel, Ph. D., president of Guided Therapeutics, Inc., the SpectRx subsidiary company commercializing the non-invasive cervical cancer device. "To date we have enrolled more than 200 patients out of 1,500 needed to complete the trial. Meanwhile, product commercialization work continues with major internal components identified, tested and priced to meet our production goals."

SpectRx management will hold a conference call to discuss fourth quarter 2004 results on Wednesday, March 30, 2005 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 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 spectrx.com, mysimplechoice.com and guidedtherapeutics.com.

Trademarks are owned by their respective companies.

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 time to time in Sp ectRx'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, 2003 and subsequent quarterly reports.

In Thousands except per share data

SpectRx, Inc. and Subsidiaries

Consolidated Condensed Statement of Operations (Unaudited)

  

Three Months Ended

Year Ended

Dec. 31

Dec. 31

In Thousands except per share data

2004

2003

2004

2003

Revenue

$675

$450

$1,348

$1,586

Expenses

Cost of Sales

234

354

1,109

1,062

Research & Development

779

798

3,618

4,108

Selling, General & Administration

564

693

2,544

2,885

Total Operating Expense

1,577

1,845

7,271

8,055

Operating Loss

(902)

(1,395)

(5,923)

(6,469)

Gain on Sale of BiliChek Product Line, including earnout

815

3,107

815

4,169

Interest & Other Income

10

(213)

(920)

(311)

Net Income (Loss)

(77)

1,499

(6,028)

(2,611)

Preferred Stock Dividends

(69)

(73)

(278)

(299)

Deemed Dividend on Preferred Shares

0

0

(4,970)

0

Net Income (Loss) Available to Common Stockholders

$(146)

$1,426

$(11,276)

$(2,910)

Basic Net Income (Loss) per Share

$0.01

$0.13

$(0.99)

$(0.26)

Diluted Net Income (Loss) per Share

$0.01

$0.12

$(0.99)

$(0.26)

Basic
Weighted Average Shares Outstanding

11,411

11,336

11,393

11,270

Diluted
Weighted Average Shares Outstanding

11,411

11,600

11,393

11,270

Selected Balance Sheet Data (Unaudited)

In Thousands except per share data

December 31, 2004

December 31, 2003

Cash Equivalents

247

389

Working Capital deficiency

(1,978)

(1,959)

Total Assets

6,017

6,714

Accumulated Deficit

(57,315)

(51,010)

Stockholders' Equity (DEFICIT)

(202)

(1,583)

Redeemable Preferred Stock, Long-term Portion

1,711

3,264

###END###

 

EX-99.2 4 spcc033005.htm EXHIBIT 99.2 SPECTRX

 

 

4Q2004 Conference Call Script

 

Opening - Bill Wells

Good morning and thank you for participating in the SpectRx conference call and webcast to discuss fourth quarter and year end 2004 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.

This conference call will consist of a management presentation followed by a question and answer session. 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 ending December 31, 2003, 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 fourth quarter 2004 conference call.

 

I am pleased to report today several recent positive events for the company as we work toward creating a successful business.

We have made considerable progress since our last call toward our near-term goals of expanding our SimpleChoice market opportunities and increasing our product offerings.

We have begun to successfully open up international markets to our SimpleChoice products, and we are close to launching our 90-degree infusion set. As we successfully complete these tasks in the coming weeks, I believe that our sales and revenue will begin to reflect our opportunity in the 360 million dollar insulin pump infusion market.

We are also continuing our partnering efforts and the work to improve our continuous glucose interstitial fluid sampling technology.

We recently received an extension and 739,000-dollar increase in funding in our contract with the National Institute on Alcohol Abuse and Alcoholism to develop a continuous alcohol sensor. This contract is part of our efforts to expand the capabilities of our interstitial fluid sampling platform beyond glucose monitoring.

Also since our last call, we have increased the number of centers involved in our non-invasive cervical cancer detection FDA trials and made progress in the commercialization of the device.

We also continue to watch expenses and dedicate resources where necessary to meet our goals.

 

 

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.

The primary focus of the SimpleChoice insulin delivery business is the successful introduction of our 90 degree set which will significantly expand our market.

A very important milestone for the company is expanding sales to overseas markets.  We have begun to ship our SimpleChoice products to European distributors and are pleased with the initial sell through and re-orders so far.  We believe that the European market will be a successful one for us.  Partially as a result of these European sales, we expect first quarter 2005 SimpleChoice revenue to be approximately $300,000.

The next important milestone for the company is to get our 90-degree infusion set out on the market.  The introduction of this product was scheduled for earlier this year, however, because of its more sophisticated design more time was required to complete vendor deliveries, refine the engineering and move the product into manufacturing. This product should allow us to enter the $250 million plus 90-degree set market with a splash.

We are now in the process of finalizing the pre-production process and are close to commencing full up production. I am wearing one of the new sets now and I am positive that its free-moving design features will make it a hot new product when it arrives on the market.

Now that the 90-degree set is in the final stages of production ramp-up, we are beginning to shift resources to the still very exciting patch product.  We will continue to add more technical resources to work on the patch and other planned products as they become available.

In summary, we are making progress, but not as quickly as Mark or I would like.  We are applying our resources to the areas that will have the most positive impact for the company.  We have been hampered by the fact that we have been delayed in getting a fully competitive product line on the market and without a fully competitive product line, it is difficult to get customers and distributors excited about the benefits of working with SimpleChoice. Also, because our current product offerings are very similar to existing products marketed by our competitors, they are more difficult to sell. For these reasons, we believe that once we get our 90-degree set on the market, we will begin to see significant improvement in sales.

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

 

Thanks Bill.

I'll turn to the unaudited financial results now.

We have had a significant increase in overall revenue driven by an increase in contract and royalty revenue as compared to earlier quarters. From an overall perspective, we are behind where we expected to be at this point following our financing last year primarily due to continued delays in broadening our product line, however SimpleChoice sales did pick up substantially in the first quarter of this year.

During the 4th of 2004 quarter we had a total of $118,000 of Simple Choice sales compared to $174,000 in the third quarter. Much of the decrease in sales was attributable to shipping delays that occurred in the last week of 2004.

The total revenue for the 4th Qtr was $675,000, including $282,000 in revenue from contracts and royalty income of $275,000. The $675,000 of total revenue compares to $450,000 in the fourth quarter of 2003.

Our quarterly operating results illustrate our continuing management of expense versus prior year. We had a decrease of $149,000, or 10%, in overall expenses for the quarter when compared to 2003. Most of that reduction is in G&A expense, which is down by $88,000 and Marketing expense, which is down by $41,000, while R&D is down by $19,000 as compared to 2003.

An important factor in controlling R&D expense is the level of R&D expense reimbursement and overhead coverage being derived from research grants and contracts. We have been very pleased with the level of reimbursement from these sources, which totaled $867,000 in 2004.

Operating loss for the quarter was $902,000, a significant improvement compared to the $1.4 million loss for the same quarter in 2003.

The net loss attributable to stockholders for the 4th quarter of 2004 was $146,000, compared to a net income of $1.4 million in the 4th quarter of the prior year. The 4th quarter 2003 net income included the $3.1 million gain recognized on the sale of the Bilicheck product line. Year to date net loss for 2004 increased to $11.3 million and compares to a loss of $2.9 million in the same period for 2003.

As we have mentioned in previous calls, comparison of net loss in 2004 to 2003 includes a one time gain of $4.2 million in 2003 on the BiliChek asset sale and two significant items related to financing activities in 2004.

The financing related items in 2004 were:

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

and,

The $ 5.0 million deemed dividend recognized in the first quarter of 2004.

Forty-four cents of the 73-cent increase in per share loss for the twelve months, was the result of the deemed dividend and 8 cents of the increase in loss was the result of interest on the warrants.

Cash on hand at the end of the fourth quarter was approximately $247,000. Stockholders' equity rose from a deficit of $1.6 million at the end of 2003 to a deficit of $202,000 - as a result of proceeds from the private placement of $7.3 million in March 2004, offset by losses incurred this year. The income statement recognition of the deemed dividend, which I described above, did not affect the balance of stockholders' equity.

I would now like to briefly discuss expectations. As we said in last quarter's conference call, we believe that the completion of the product line will enable us to grow revenues significantly over the next year. The delays in launching quick, however, and the continued development required for patch will push out the ramp up of revenue run rate from what we had expected.

We are watching cash very carefully. Our cash balance at the end of the fourth quarter was $247,000. However, our Accounts Receivable at the end of December was $1.3 million and vast majority of that was collected in the first two months of 2005.

Our product sales grew substantially in the first quarter which has led to a need for increased working capital to finance inventory and accounts receivable. These pressures are expected to intensify once we achieve the anticipated introduction of our 90-degree infusion set, with the first significant volumes in the second and third quarters of this year. Our immediate plan to deal with these additional needs for capital revolve around securing some level of financing for our growing inventory and accounts receivable. However, even with some level of financing, these requirements for working capital will require some interim financing, or other funding, before the end November of this year. If we are unable to secure appropriate working capital or have additional setbacks and delays, we will have to raise additional funds sooner.

Our expectation is that if we can meet our launch timing and control the related costs, we can generate sufficient growth in these products to get to a level of cash flow breakeven by the first half of next year. We have already taken significant action in regard to internal expenses, and are examining several alternatives for additional funding including both debt and equity based financing.

 

Turning now back to business unit activity.....

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. Our goal is to eventually separate the Guided Therapeutics entity from SpectRx, and fund the new company with venture capital or other outside investment.

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

Thanks Mark.

As mentioned earlier, we continue to have success in the FDA pivotal clinical trial of our non-invasive cervical cancer detection device.

We now have three of six planned clinical sites up and running. They are Parkland hospital in Dallas, Emory University/Grady hospital in Atlanta and the University of Miami.

We plan on bringing the fourth site on line next month and the remaining sites during Q2 and Q3. To date we have enrolled 223 patients out of the approximately 1,500 needed to complete the trial.

Meanwhile, product commercialization work continues with major internal components identified, tested and priced to meet our production goals. In particular, we have received shipments of the commercial version of the device's key component with a successful outcome to its testing. Results of these tests were included in our progress update to NCI last December.

In addition, our Principal Investigators, many of whom are opinion leaders in the Ob-Gyn field, have been putting the final touches on two manuscripts that will be submitted to peer-reviewed journals.

Funding for clinical trials and commercialization is supported by grants from the National Cancer Institute and the Georgia Research Alliance. In particular, total funding from NCI is expected to be approximately $1.6MM for 2005.

As you will 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 1,200 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 single-patient-use calibration disposables. 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.

Although we have been disappointed in the delays, I am very excited about the promise of the new SimpleChoice 90-degree infusion set which appears set to enter the market in the very near future. Customers who have seen the product have great things to say about it and both Bill and I think it should make a significant, positive difference in our revenue picture over the coming quarters. We also continue to be excited about the potential for Patch, however there is additional work to do before we can get this product to the market.

Our strategic plan to spin out the cervical cancer detection program was based on the timeframe for reaching cash flow breakeven with the cervical cancer product and the significant funding required to reach cash flow breakeven as compared to SimpleChoice. We still think this is the correct strategy, however this project has made great strides toward regulatory approval and commercialization over the past two years. In our opinion, its value has increased remarkably and due to the extraordinary efforts of our team, and the support of the NCI, we are more confident than ever that this could be a big value creator for SpectRx shareholders in the future, either as a part of Spectrx or as a stand alone company.

In summary, I believe we have an opportunity to achieve many of the goals that we have been striving for by the end of this year and in 2006. We plan continue to apply resources carefully and maintain our focus on building a successful profitable company.

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

At this time, I would like to turn the call over to the operator for questions.

After Questions

Thank you operator and thank you for participating in our fourth quarter 2004 conference call.

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