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GTHP > SEC Filings for GTHP > Form 10-Q on 14-Aug-2013All Recent SEC Filings

Show all filings for GUIDED THERAPEUTICS INC

Form 10-Q for GUIDED THERAPEUTICS INC


14-Aug-2013

Quarterly Report


ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Statements in this report which express "belief," "anticipation" or "expectation," as well as other statements which are not historical facts, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from historical results or anticipated results, including those set forth under "Risk Factors" below and elsewhere in this report, as well as in our annual report on Form 10-K for the year ended December 31, 2012. Examples of these uncertainties and risks include, but are not limited to:

the dependence on potential strategic partners or outside investors for funding, development assistance, clinical trials, distribution
and marketing of our products; access to sufficient debt or equity capital to meet our operating and financial needs;
the effectiveness and ultimate market acceptance of our products;
whether our products in development will prove safe, feasible and effective;
whether and when we or any potential strategic partners will obtain approval from the U.S FDA and corresponding foreign agencies;
our need to achieve manufacturing scale-up in a timely manner, and our need to provide for the efficient manufacturing of sufficient quantities of our products;
the lack of immediate alternate sources of supply for some critical components of our products;
our patent and intellectual property position; and
the need to fully develop the marketing, distribution, customer service and technical support and other functions critical to the success of our product lines.

The following discussion should be read in conjunction with our financial statements and notes thereto included elsewhere in this report.

OVERVIEW

We are a medical technology company focused on developing innovative medical devices that have the potential to improve healthcare. Our primary focus is the development of our LuViva non-invasive cervical cancer detection device and extension of our cancer detection technology into other cancers, including lung and esophageal. Our technology, including products in research and development, primarily relates to biophotonics technology for the non-invasive detection of cancers.

We are a Delaware corporation, originally incorporated in 1992 under the name "SpectRx, Inc.," and, on February 22, 2008, changed our name to Guided Therapeutics, Inc. At the same time, we renamed our majority owned subsidiary, InterScan, which originally had been incorporated as "Guided Therapeutics."

Since our inception, we have raised capital through the private sale of preferred stock and debt securities, public and private sales of common stock, funding from collaborative arrangements, and grants.

Our prospects must be considered in light of the substantial risks, expenses and difficulties encountered by entrants into the medical device industry. This industry is characterized by an increasing number of participants, intense competition and a high failure rate. We have experienced operating losses since our inception and, as of June 30, 2013, we had an accumulated deficit of about $96.8 million. To date, we have engaged primarily in research and development efforts. We do not have significant experience in manufacturing, marketing or selling our products. Our development efforts may not result in commercially viable products and we may not be successful in introducing our products. Moreover, required regulatory clearances or approvals may not be obtained in a timely manner, or at all. Our products may not ever gain market acceptance and we may not ever generate significant revenues or achieve profitability. The development and commercialization of our products requires substantial development, regulatory, sales and marketing, manufacturing and other expenditures. We expect our operating losses to continue through at least the end of 2013 as we continue to expend substantial resources to introduce LuViva, further the development of our other products, obtain regulatory clearances or approvals, build our marketing, sales, manufacturing and finance organizations and conduct further research and development.

CRITICAL ACCOUNTING POLICIES

Our material accounting policies, which we believe are the most critical to an investors understanding of our financial results and condition, are discussed below. Because we are still early in our enterprise development, the number of these policies requiring explanation is limited. As we begin to generate increased revenue from different sources, we expect that the number of applicable policies and complexity of the judgments required will increase.

Currently, our policies that could require critical management judgment are in the areas of revenue recognition, reserves for accounts receivable and inventory valuation.

Revenue Recognition:We recognize revenue from contracts on a straight line basis, over the terms of the contract. We recognize revenue from grants based on the grant agreement, at the time the expenses are incurred. Revenue from the sale of the Company's products is recognized upon shipment of such products to its customers.

Valuation of Deferred Taxes: We account for income taxes in accordance with the liability method. Under the liability method, we recognize deferred assets and liabilities based upon anticipated future tax consequences attributable to differences between financial statement carrying amounts of assets and liabilities and their respective tax bases. We establish a valuation allowance to the extent that it is more likely than not that deferred tax assets will not be utilized against future taxable income.

Stock Option Plan: We measure the cost of employees services received in exchange for equity awards, including stock options, based on the grant date fair value of the awards. The cost will be recognized as compensation expense over the vesting period of the awards.

Warrants: We have issued warrants, which allow the warrant holder to purchase one share of stock at a specified price for a specified period of time. We record equity instruments, including warrants issued to non-employees, based on the fair value at the date of issue. The fair value of the warrants, at date of issuance, is estimated using the Black-Scholes Model.

Allowance for Inventory Valuation:We estimate losses from obsolete and damaged inventories quarterly and revise our reserves as a result.

Allowance for Accounts Receivable:We estimate losses from the inability of our customers to make required payments and periodically review the payment history of each of our customers, as well as their financial condition, and revise our reserves as a result.

RESULTS OF OPERATIONS

COMPARISON OF THE THREE MONTHS ENDED JUNE 30, 2013 AND 2012

Service Revenue: Service revenue decreased to approximately $222,000 for the quarter ended June 30, 2013, from approximately $915,000, for the same period in 2012. Service revenue was lower for the second quarter 2013 due to the termination of certain collaborative agreements with Konica Minolta.

Sales Revenue, Cost of Sales and Gross Loss from Devices and Disposables: Sales revenue from the sale of LuViva devices and disposables for the three months ended June 30, 2013, was approximately $116,000. Related costs of sales were approximately $119,000, which resulted in a gross loss for the device and disposables of approximately $3,000. For the same period last year, sales revenue from the sale of LuViva devices and disposables for the three months ended June 30, 2012, was approximately $29,000. Related costs of sales were approximately $75,000, which resulted in a gross loss on the device and disposables of approximately $46,000.

On April 17, 2013, we announced that we shipped our first Edition 3 CE marked LuViva devices to our distributor in Turkey. The delivery was the first of approximately 15 units we planned to manufacture and ship to distributors in the second quarter of 2013. Purchase orders for 13 units were received and six units were shipped in the second quarter. Due to a requested software change by our Turkish distributor and a shipping schedule change by our Nigerian distributor, the remaining units are scheduled to be shipped early in the third quarter of 2013. On July 2, 2013, we announced receipt of purchase orders for $3 million in LuViva device and disposable sales to the Turkish Ministry of Health. Shipment of that order is scheduled to begin in the third quarter of 2013 and continue through the end of 2014.

Research and Development Expenses: Research and development expenses decreased to approximately $834,000 for the three months ended June 30, 2013, compared to $898,000 for the same period in 2012. The decrease, of approximately $64,000, was primarily due to a decrease in research and development for our cervical cancer detection product, as we shift resources toward marketing and production.

Sales and Marketing Expenses: Sales and marketing expenses were approximately $195,000 during the three months ended June 30, 2013, compared to $69,000 for the same period in 2012. The increase was primarily due to efforts underway in marketing our cervical cancer detection product.

General and Administrative Expenses: General and administrative expenses decreased to approximately $931,000 during the three months ended June 30, 2013, compared to approximately $1.1 million for the same period in 2012. The decrease of approximately $119,000, or 11%, is primarily related to a decrease in employee compensation recorded for the three months ended June 30, 2013.

Interest Expense: Interest expense decreased to approximately $9,000 for the three months ended June 30, 2013, as compared to approximately $19,000 for the same period in 2012, primarily due to repayment of outstanding notes.

Net loss was approximately $1.8 million during the three months ended June 30, 2013, compared to $1.2 million for the same period in 2012, for the reasons outlined above.

COMPARISON OF THE SIX MONTHS ENDED JUNE 30, 2013 AND 2012

Service Revenue: Service revenue decreased to approximately $389,000 for the six months ended June 30, 2013, from approximately $1.6 million for the same period in 2012. Service revenue, for the six months ended June 30, 2013, was lower than the comparable period in 2012, due the termination of certain agreements with Konica Minolta.

Sales Revenue, Cost of Sales and Gross Loss from Devices and Disposables: Sales revenue from the sale of LuViva devices and disposables for the six months ended June 30, 2013, was approximately $248,000. Related costs of sales were approximately $277,000, which resulted in a gross loss for the device and disposables of approximately $29,000. For the same period last year, sales revenue from the sale of LuViva devices and disposables for the six months ended June 30, 2012, was approximately $29,000. Related costs of sales were approximately $75,000, which resulted in a gross loss on the device and disposables of approximately $46,000.

Research and Development Expenses: Research and development expenses remained unchanged at approximately $1.6 million for the six months ended June 30, 2013 and 2012.

Sales and Marketing Expenses: Sales and marketing expenses were approximately $359,000 during the six months ended June 30, 2013, compared to $139,000 for the same period in 2012. The increase, of approximately $220,000, was primarily due to an increase in expenses relating to marketing efforts for the cervical cancer detection products in development.

General and Administrative Expenses: General and administrative expenses remained unchanged at approximately $2.0 million during the six months ended June 30, 2013 and 2012.

Other Income: Other income was $75,000 for the six months ended June 30, 2013, compared to zero for the same period in 2012. Other income for the six months ended June 30, 2013, was associated with a royalty payment on our licensing agreement and miscellaneous income.

Interest Expense: Interest expense decreased to approximately $24,000 for the six months ended June 30, 2013, as compared to approximately $36,000 for the same period in 2012. The decrease is primarily due to the decrease in interest expense on lower loan balances for the six months ended June 30, 2013.

Net loss was approximately $3.6 million during the six months ended June 30, 2013, compared to $2.2 million for the same period in 2012. The increase of approximately $1.3 million was due to a direct reduction in our service revenue, due to the termination of certain collaborative agreements with Konica Minolta.

LIQUIDITY AND CAPITAL RESOURCES

Since our inception, we have raised capital through the private sale of preferred stock and debt securities, public and private sales of common stock, funding from collaborative arrangements, and grants. At June 30, 2013, we had cash of approximately $2.0 million and working capital of approximately $1.3 million.

Our major cash flows in the quarter ended June 30, 2013, consisted of cash out-flows of approximately $2.8 million from operations, including approximately $3.6 million of net loss, cash outflow of $101,000 from investing activities and a net change from financing activities of $3.8 million, which primarily represents the proceeds received from the issuance of our Series B Preferred Stock, exercise of outstanding warrants and options, offset in part by cash utilized for loan repayment.

On May 24, 2013, we completed a private placement of our Series B Preferred Stock and warrants to purchase shares of our common stock. We issued an aggregate of 2,527 shares of our Series B Preferred Stock at a purchase price of $1,000 per share, subject to the terms of a Securities Purchase Agreement, dated May 21, 2013, between us and certain accredited investors. We also issued warrants, on a pro rata basis to the investors, exercisable to purchase an aggregate of 3,716,177 shares of our common stock. The warrants, which carry a five-year term, were split evenly into two tranches, one of which is subject to a mandatory exercise provision. The warrants are exercisable at any time at an exercise price of $1.08 per share, subject to certain customary adjustments contained in the respective warrants. In connection with the private placement, we entered into a registration rights agreement with the investors pursuant to which we have certain contractual obligations to register the shares of common stock issuable upon conversion of our Series B Preferred Stock and exercise of the warrants.

We will be required to raise additional funds through public or private financing, additional collaborative relationships or other arrangements. We believe our existing and available capital resources will be sufficient to satisfy our funding requirements through the fourth quarter of 2014. We are evaluating various options to further reduce our cash requirements to operate at a reduced rate, as well as options to raise additional funds, including loans.

Substantial capital will be required to develop our products, including completing product testing and clinical trials, obtaining all required U.S. and foreign regulatory approvals and clearances, and commencing and scaling up manufacturing and marketing our products. Any failure to obtain capital would have a material adverse effect on our business, financial condition and results of operations.

Our financial statements have been prepared and presented on a basis assuming we will continue as a going concern. However, we have experienced operating losses since our inception and, as of June 30, 2013, had an accumulated deficit of approximately $96.8 million, working capital of approximately $1.3 million and stockholders' equity of approximately $1.7 million. These factors raise substantial doubt about our ability to continue as a going concern, as more fully discussed in Note 1 to the consolidated financial statements contained herein and in the report of our independent registered public accounting firm accompanying our financial statements contained in our annual report on Form 10-K for the year ended December 31, 2012.

Off-Balance Sheet Arrangements

We have no material off-balance sheet arrangements, no special purpose entities, and no activities that include non-exchange-traded contracts accounted for at fair value.

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