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LED Medical Diagnostics Reports 2012 Third Quarter Results

Wed, 11/14/2012 - 4:45pm
The Associated Press

LED Medical Diagnostics Inc. (TSX VENTURE:LMD) ("LED" or the "Company"), manufacturer of the VELscope Vx® the market-leading early-stage oral cancer detection device, today announced its financial results for the third quarter ended September 30, 2012, reported in Canadian dollars and in accordance with International Financial Reporting Standards ("IFRS"). The Company's results are presented in comparison to the three months ended June 30, 2012 and the three months ended September 30, 2011, also in accordance with IFRS.

The third quarter was characterized by increase of revenues by 181% over the third quarter of 2011. The gains come hard on the heels of a strategic alliance with DenMat Holdings, LLC, the exclusive manager of LED's global distribution strategy.

"Demand for the VELscope Vx is escalating," said LED's founder and CEO, Peter Whitehead. "Our presence at the annual American Dental Association ("ADA") Tradeshow generated 100% more sales than the year before. In addition, LED's Call Centre sales were significantly up for the month of October. We attribute much of our recent success to DenMat's marketing efforts, which are raising LED's profile and building domestic and international demand for our products."

"Dentists across the globe are making a commitment to a new dimension of patient care," said Steven Semmelmayer, DenMat's CEO. "The early detection of lesions and tissue abnormalities is an important part of that commitment, and the VELscope Vx is the original and most effective discovery tool available. DenMat is proud to carry forward the banner of early oral cancer detection to the worldwide dental profession, and pleased to see our efforts translate into gains for LED."

Business Highlights

Notable developments and achievements in the third quarter included the following:


--  To conduct marketing and distribution efforts more profitably, the
    distribution agreement with Henry Schein was amended in September 2012
    in which the Company enabled Henry Schein to continue market its
    products to a limited defined market and agreed to purchase up to a
    maximum of U.S. $1.7 million of VELscope inventory from Henry Schein
    over the period ending December 15, 2013. The Company's VELscope
    products are available through a variety of channels. 

--  An important strategic alliance with DenMat Holdings, LLC was formed to
    raise the VELscope Vx to an entirely new level of name-brand recognition
    and to maximize the VELscope's global presence.

--  With over 12,000 units sold, LED estimates that 25 million oral scans
    have been performed worldwide, making the VELscope Vx by far the leading
    global technology for the early detection of oral disease, including
    oral cancer.

From our leadership position in adjunctive screening for oral cancer, and as per previous comments in our annual report, we are expanding our product offerings of adjunctive screening technology for other cancers. We will continue to update you on these developments and our progress.

Three Month Comparative Results

For the three months ended September 30, 2012, the Company reported revenues of $1.6 million, compared with $1.8 million for the three months ended June 30, 2012 and $556,000 for the three months ended September 30, 2011. The Company reported a loss of $161,000 for the three months ended September 30, 2012 compared to a profit of $43,000 for the three months ended June 30, 2012 and a loss of $1,019,000 for the three months ended September 30, 2011. Gross margin(1) was 63 per cent for the three months ended September 30, 2012 compared with 62 per cent for the three months ended June 30, 2012 and 66 per cent for the three months ended September 30, 2011. The Company's margins vary depending on the mix of equipment versus disposables sales for any given period.

Total expenses (excluding other operating expenses)(2) for the three months ended September 30, 2012 were 3 per cent higher than the three months ended June 30, 2012, but 19 per cent lower than the three months ended September 30, 2011. EBITDA(3) for the three months ended September 30, 2012 was ($118,000) compared to $47,000 for the three months ended June 30, 2012 and ($998,000) for the three months ended September 30, 2011.

Nine Month Comparative Results

For the nine months ended September 30, 2012, the Company reported revenues of $5.2 million, compared with $5.1 million for the nine months ended September 30, 2011. The Company reported a loss of $506,000 compared to a loss of $1,139,000 for the nine months ended September 30, 2011. Gross margin was 61 per cent for the nine months ended September 30, 2012 compared to 57 per cent for the nine months ended September 30, 2011. The Company's margins vary depending on the mix of equipment versus disposables sales for any given period.

(1) Non-IFRS measure that does not have a standard meaning and may not be comparable to a similar measure disclosed by other issuers. Gross Margin referenced here relates to revenues less cost of sales.

(2) Non-IFRS measure that does not have a standard meaning and may not be comparable to a similar measure disclosed by other issuers. Total Expenses excludes other operating expenses.

(3) Non-IFRS measure that does not have a standardized meaning and may not be comparable to a similar measure disclosed by other issuers. This measure does not have a comparable IFRS measure. EBITDA referenced here relates to operating loss less amortization and depreciation. Please refer to the reconciliation of EBITDA to reported financial results attached to this press release.

Total expenses (excluding other operating expenses) for the nine months ended September 30, 2012 were 13 per cent lower than for the nine months ended September 30, 2011. EBITDA for the nine months ended September 30, 2012 was ($423,000) compared to ($1,182,000) for the nine months ended September 30, 2011.

Cash and cash equivalents were $388,000 with net working capital(4) of $92,000 as of September 30, 2012 compared to cash and cash equivalents of $992,000 with net working capital of $570,000 as of December 31, 2011.

The Audit Committee of the Company has reviewed the contents of this news release.

Non-IFRS Measures

The following and preceding discussion of financial results includes reference to Gross Margin, Total Expenses (excluding other operating expenses), EBITDA and Working Capital, which are all non-IFRS financial measures. The measure of gross margin is provided as management believes this is a good indicator in evaluating of the operating performance of the Company. EBITDA is defined as operating loss less other operating expenses. The measure is provided as a proxy for the cash earnings from the operations of the business as operating loss for the Company includes non-cash amortization and depreciation expense. The measure of working capital is provided as management believes this is a good indicator of the operating liquidity available to the Company.

Forward-Looking Statements

This press release contains statements which, to the extent that they are not recitations of historical fact, may constitute forward-looking information under applicable Canadian securities legislation that involve risks and uncertainties. Such forward-looking statements or information may include financial and other projections as well as statements regarding the Company's future plans, objectives, performance, revenues, growth, profits, operating expenses or the company's underlying assumptions. The words "may", "would", "could", "will", "likely", "expect", "anticipate", "intend", "plan", "forecast", "project", "estimate" and "believe" or other similar words and phrases may identify forward-looking statements or information. Persons reading this press release are cautioned that such statements or information are only predictions, and that the Corporation's actual future results or performance may be materially different. Factors that could cause actual events or results to differ materially from those suggested by these forward-looking statements include, but are not limited to: economic conditions; dilution; limited history of profits and operations; operational risk; distributor risks; working capital; potential conflicts of interest; speculative investment; volatility of stock price; intellectual property risks; disruptions in production; reliance on key personnel; seasonality; management's estimates; competitors; regulatory requirements; reliance on few suppliers; reliance on subcontractors; technological milestones; operating cost fluctuations; fluctuations in exchange rates; product liability and medical malpractice claims; access to credit; taxation; potential unknown liabilities; the possibility of development or deployment difficulties or delays; the dependence on its customers' satisfaction; the timing of entering into significant contracts; the performance of the global economy; market acceptance of the Corporation's products and services;

customer and industry analyst perception of the Corporation and its technology vision and future prospects; the success of certain business combinations engaged in by the Corporation or by its competitors; possible disruptive effects of organizational or personnel changes; technological change, new products and standards; risks related to acquisitions and international expansion; reliance on large customers; concentration of sales; international operations and sales; management of growth and expansion; dependence upon key personnel and hiring; reliance on a limited number of suppliers; risks related to the Corporation's competition; the Corporation not adequately protecting its intellectual property; risks related to product defects and product liability; currency exchange rate risk; and including, but not limited to, other factors described in the Corporation's reports filed on SEDAR including its Annual Information Form and financial report for the year ended December 31, 2011. This list is not exhaustive of the factors that may affect the Company's forward-looking information. These and other factors should be considered carefully and readers should not place undue reliance on such forward-looking information. All forward-looking statements made in this press release are qualified by this cautionary statement and there can be no assurance that actual results or developments anticipated by the Company will be realized. The Company disclaims any intention or obligation to update or revise forward-looking information, whether as a result of new information, future events or otherwise, except as required by law.

(4) Non-IFRS measure that does not have a standardized meaning and may not be comparable to a similar measure disclosed by other issuers. This measure does not have a comparable IFRS measure. Working Capital is defined as current assets less current liabilities.

About LED Medical Diagnostics Inc.

LED Medical Diagnostics Inc. was founded in 2003 and is headquartered in Burnaby, British Columbia, Canada. Its wholly-owned subsidiary, LED Dental Inc., is the manufacturer of the Velscope Vx Enhanced Oral Assessment System. Velscope Vx devices, the first to apply tissue fluorescence visualization technology to the oral cavity, are used to conduct more screenings for oral cancer and other oral diseases than any other adjunctive device in the world. To date, the VELscope has sold over 12,000 units, and been used to perform an estimated 20 million exams. For more information, call +1 (604) 434-4614, or visit www.velscope.com.

About DenMat Holdings LLC

DenMat manufactures a broad range of cosmetic, restorative and clinical product solutions, available in the U.S. and over 68 countries worldwide. Ongoing partnerships have been instrumental in positioning DenMat at the forefront of the dental industry. For more information, call 800-433-6628 or visit www.denmat.com.

About the VELscope Vx

The Velscope Vx is a powerful FDA-approved tool used to screen for oral cancer. It saves lives and decreases morbidity by helping clinicians detect early stage oral cancer, pre-cancer, and other abnormalities in the mouth such as viral, fungal and bacterial infections. The Velscope Vx is exclusively distributed worldwide through a partnership with DenMat Holdings, LLC, the U.S. dental company with products in over 68 countries worldwide. For more information please call +1 (604) 434-4614, or visit www.velscope.com.

Please visit www.sedar.com for LED Medical Diagnostics Inc.'s complete annual report. If you require a hard copy please call Investor Relations.

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