Completed PAZ320 Phase II Clinical Trial Yields Excellent Results
MANCHESTER, NH -- (Marketwired) -- 04/04/13 -- Boston Therapeutics, Inc. (OTCQB: BTHE) ("Boston Therapeutics" or "the Company"), a developer of complex carbohydrates to treat diabetes and inflammatory diseases, today announced financial results for the full year ended December 31, 2012. These results are included in the Company's Annual Report on Form 10-K, which has been filed with the SEC.
"I am proud of the progress we have made over the past year as we have enhanced the Company's status as a premier carbohydrate-based pharmaceutical company focused on the discovery, development and commercialization of new chemical entities," said David Platt, Ph.D., Chief Executive Officer of Boston Therapeutics. "We brought one product, SUGARDOWN®, to market in 2012 and have begun to make initial sales. We expect our lead pharmaceutical compound PAZ320 to enter a Phase III clinical trial later this year.
"PAZ320 is a non-systemic, non-toxic, chewable drug candidate designed to reduce the elevation of post-prandial glucose (PPG), or after-meal blood sugar. Patients with type 2 diabetes who responded in the Phase II study reported a 40% reduction in PPG and no Serious Adverse Events; an excellent result. Our second compound is IPOXYN™, an injectable prescription drug candidate for prevention of necrosis and treatment of lower limb ischemic conditions which may lead to necrosis. I am enthusiastic about the potential of these products to address unmet medical needs and to position us as an innovative developer of carbohydrate-based pharmaceutical drugs," Dr. Platt stated.
Financial Results for the Full Year 2012
Revenue for the year ended December 31, 2012 increased to $42,254 compared with $4,112 for the prior year, an increase of $38,142 primarily because SUGARDOWN® was sold for a full year. Sales in 2012 included approximately $31,000 of sales to two customers for resale and approximately $11,200 of sales to individual customers through our website. Cost of goods sold for the year ended December 31, 2012 was $56,859 compared with $6,375 in the prior year, an increase of $50,484 primarily due to a full year of cost related to the sales of SUGARDOWN®. The Company's negative gross profit is attributable to cost of goods sold outpacing sales as a result of additional fixed costs related to moving to a new fulfillment operation and manufacturing scale-up from small to production grade equipment.
Research and development expense for the year ended December 31, 2012 was $178,938, compared with $194,276 for the prior year, a decrease of $15,338. Product development expense increased by approximately $10,000 over the year ended December 31, 2011 and direct research and development decreased by approximately $25,000 over the prior year.
Sales and marketing expense were $232,411 for the year ended December 31, 2012, compared with $206,517 for the prior year, an increase of $25,894. The 2012 expense represents costs incurred for advertising and promotion, marketing and stock-based compensation expenses associated with the commercialization of SUGARDOWN®.
General and administrative expense for the year ended December 31, 2012 was $1,036,566 compared with $408,454 for the prior year, an increase of $628,112. The overall increase is primarily the result of increased stock-based compensation expenses, as well as increased consulting and investor relations.
The Company had a net loss of $1,484,115, or ($0.09) per share, for the year ended December 31, 2012 with a net loss of $827,168 or ($0.05) for the prior year. The Company's cash balance at December 31, 2012 was $552,315. In February 2013, the Company raised $250,000 pursuant to our S-1 Registration Statement. The weighted average shares outstanding for the year ended December 31, 2012 were 16,873,903.
About Boston Therapeutics, Inc.
Boston Therapeutics, headquartered in Manchester, NH, (OTCQB: BTHE) is a leader in the field of complex carbohydrate chemistry. The Company's product pipeline is focused on developing and commercializing therapeutic molecules for diabetes, including PAZ320, a non-systemic chewable therapeutic compound designed to reduce the elevation of post-prandial glucose (PPG) or post-meal blood sugar, and IPOXYN™, an injectable anti-necrosis drug specifically designed to treat lower limb ischemia associated with diabetes. More information is available at www.bostonti.com.
Forward Looking Statements
Any statements in this news release about future expectations, plans and prospects for the Company constitute forward-looking statements as defined in the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management's current expectations and are subject to a number of factors and uncertainties, which could cause actual results to differ materially from those described in such statements.
More information about those risks and uncertainties is contained and discussed in the Company's most recent quarterly or annual report and in the Company's other reports filed with the Securities and Exchange Commission. The forward-looking statements represent the Company's views as of the date of this news release and should not be relied upon to represent the Company's views as of a subsequent date. While the Company anticipates that subsequent events may cause the Company's views to change, the Company disclaims any obligation to update such forward-looking statements.