|By Marketwired .||
|May 13, 2014 12:23 PM EDT||
MANCHESTER, NH -- (Marketwired) -- 05/13/14 -- Boston Therapeutics, Inc. (OTCQB: BTHE) ("Boston Therapeutics" or "the Company"), a leading developer of compounds that address diabetes using complex carbohydrate chemistry, reports its financial results for the first quarter ended March 31, 2014.
David Platt, Ph.D., Chief Executive Officer, Boston Therapeutics, said, "In the first quarter, we have continued to work toward fulfilling the milestones we outlined in last quarter's year-end corporate update. Since that time, I am pleased to announce that we have continued to disseminate scientific findings regarding BTI-320, and have initiated steps to prepare for its future development. Specifically, we are pleased to be presenting a poster on the mechanism of action of BTI-320 at the AACE Annual Congress in Las Vegas, and look forward to presenting further results on the properties of this compound in the future. Furthermore, our recently signed agreement with Patheon Inc. to manufacture pharmaceutical-grade tablets of BTI-320 positions us well for our upcoming IND filing later this year, and our planned international Phase III trial for BTI-320 in 2015. All of these efforts will allow us to continue to harness our expertise in complex carbohydrate chemistry to design compounds to better manage blood glucose."
Business and Clinical Highlights for the First Quarter 2014 and Recent Months:
- Announced the presentation of a late-breaking poster on the mechanism of action for BTI-320 at the American Association of Clinical Endocrinologists (AACE) 23rd Annual Scientific and Clinical Congress at the Paris Las Vegas Hotel in Las Vegas, Nevada. BTI-320 is a non-systemic chewable complex carbohydrate-based compound designed to reduce post-meal elevation of blood glucose.
- Signed agreement (along with the Company's Hong Kong-based strategic partner Advance Pharmaceutical Company) with pharmaceutical manufacturing company Patheon Inc. to manufacture pharmaceutical-grade tablets of BTI-320, in advance of the Company's anticipated IND filing in late 2014 and its planned international Phase III trial for BTI-320 in 2015.
Financial Results for the First Quarter Ended March 31, 2014:
- Cash and cash equivalents as of March 31, 2014 were $2,512,404 compared with $3,387,428 as of December 31, 2013.
- Revenue for the first quarter ended March 31, 2014 was $43,827, compared with $23,336 in the prior year's first quarter. Revenue for the quarter was generated from the sale of SUGARDOWN®.
- Gross margin for the first quarter ended March 31, 2014 was a deficit of ($10,731), compared with a deficit of ($24,601) in the prior year's first quarter. The gross margin deficit for the first quarter ended March 31, 2014 was primarily related to a one-time material cost charge and continued fixed fulfillment charges. The improvement in gross margin is primarily related to the increase in revenue.
- Research and development expense for the first quarter ended March 31, 2014 was $269,434 compared with $28,661 for the prior year's first quarter. The increase in research and development is primarily the result of expenses associated with Phase II trial activities for BTI-320.
- Sales and marketing expense for the first quarter ended March 31, 2014 was $172,735, compared with $81,226 in the prior year's quarter. The increase is primarily related to the engagement of a healthcare marketing company to market SUGARDOWN® and the hiring of employees to support our sales and marketing initiatives. Subsequent to the quarter ended March 31, 2014, the Company ended the agreement with the healthcare marketing company and is currently pursuing alternative marketing partners.
- General and administrative expense for the first quarter ended March 31, 2014 was $1,105,230, an increase of $577,060 as compared to $528,170 for the first quarter ended March 31, 2013. Approximately $313,000 of the increase is related to non-cash, stock-based compensation primarily related to fully vested options granted during the first quarter ended March 31, 2014. Consulting and professional services increased $132,000 primarily due to our business development, public relations and investor relations activities. Accounting, financial and legal professional fees increased $80,000 primarily due to the indemnification of Dr. Platt's legal costs associated with his arbitration and the engagement of a finance professional to manage its accounting and financial reporting matters. In addition, payroll and payroll related expense increased $62,000 due to salary increases, the institution of an employee medical benefit program and the hiring of two new employees.
- Net loss for the first quarter ended March 31, 2014 was $1,566,423 or $0.04 per share, compared with a net loss of $667,422 or $0.04 per share in the prior year's first quarter. As of March 31, 2014, there were 37,451,156 million weighted average shares outstanding, compared with 18,880,845 million weighted average shares outstanding as of March 31, 2013.
We have incurred recurring operating losses since inception as we have worked to bring our SUGARDOWN® product to market and develop BTI-320 and IPOXYN. IPOXYN is an injectable anti-necrosis drug specifically designed to treat lower limb ischemia associated with diabetes. We expect such operating losses will continue until such time that we receive substantial revenues from SUGARDOWN® or we complete the regulatory and clinical development of BTI-320 or IPOXYN. We anticipate that our cash resources will be sufficient to fund our planned operations into the second half of fiscal 2014. We plan to seek additional capital through private placements and public offerings of the Company's common stock. There can be no assurance that the Company will be successful in accomplishing its objectives. Without such additional capital, the Company may be required to curtail or cease operations.
BTI-320 is a non-systemic chewable complex carbohydrate-based compound designed to reduce post-meal elevation of blood glucose. BTI-320 is a proprietary polysaccharide to be taken before meals and works in the gastrointestinal tract to block the action of carbohydrate-hydrolyzing enzymes that break down complex carbohydrates into simple sugars, reducing the availability of glucose for absorption into the bloodstream.
About Boston Therapeutics, Inc.
Boston Therapeutics, headquartered in Manchester, NH, (OTCQB: BTHE) is an innovator in designing compounds using complex carbohydrate chemistry. The company's product pipeline is focused on developing and commercializing therapeutic molecules that address diabetes and inflammatory diseases, including: BTI-320 (formerly PAZ320), a non-systemic chewable therapeutic compound designed to reduce post-meal glucose elevation, and IPOXYN, an injectable anti-necrosis drug specifically designed to treat lower limb ischemia associated with diabetes. The company also produces and sells SUGARDOWN®, a non-systemic complex carbohydrate-based dietary food supplement designed to support healthy blood glucose. More information is available at www.bostonti.com.
Cautionary Note Regarding Forward Looking Statements
This press release contains, in addition to historical information, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as "may," "estimate," "could," "expect" and others. They are based on our current expectations and are subject to factors and uncertainties which could cause actual results to differ materially from those described in the statements. Factors that could cause our actual performance to differ materially from those discussed in the forward-looking statements include, among others, that our plans, expectations and goals regarding the clinical trials are subject to factors beyond our control and provide no assurance of FDA approval of any of our future drug development plans. Our clinical trials may not produce positive results in a timely fashion, if at all, and any necessary changes during the course of the trial could prove time consuming and costly. We may have difficulty in enrolling candidates for testing, which would affect our estimates regarding timing, and we may not be able to achieve the desired results. Any significant delays or unanticipated costs in any subsequent drug trial could delay obtaining meaningful results from Phase II studies and/or preparing for Phase III studies with the current cash on hand.
Upon receipt of FDA approval, we may face competition with other drugs and treatments that are currently approved or those that are currently in development, which could have an adverse effect on our ability to achieve revenues from our approved products. Plans regarding development, approval and marketing of any of our compounds, including BTI-320, are subject to change at any time based on the changing needs of our company as determined by management and regulatory agencies. We have incurred operating losses since our inception, and our ability to successfully develop and market drugs may be affected by our ability to manage costs and finance our continuing operations. For a discussion of additional risk and other factors affecting our business, see our Annual Report on Form 10-K for the year ended December 31, 2013, and our subsequent filings with the SEC. You should not place undue reliance on forward-looking statements, and actual results may differ materially from the results anticipated in our forward-looking statements. Although subsequent events may cause our views to change, we disclaim any obligation to update forward-looking statements.
Boston Therapeutics, Inc. Statement of Operations (Unaudited) Three Months Ended March 31, -------------------------- 2014 2013 ------------ ------------ Revenue $ 43,827 $ 23,336 Cost of goods sold 54,558 47,937 ------------ ------------ Gross margin (deficit) (10,731) (24,601) Operating expenses: Research and development 269,434 28,661 Sales and marketing 172,735 81,226 General and administrative 1,105,230 528,170 ------------ ------------ Total operating expenses 1,547,399 638,057 Operating loss (1,558,130) (662,658) Interest expense (4,728) (4,764) Other expense (2,940) - Foreign currency loss (625) - ------------ ------------ Net loss $ (1,566,423) $ (667,422) ============ ============ Net loss per share - basic and diluted $ (0.04) $ (0.04) Weighted average shares outstanding basic and diluted 37,451,156 18,880,845 Boston Therapeutics, Inc. Balance Sheet Data March 31, December 31, 2014 2013 ------------- ------------- Cash and cash equivalents $ 2,512,404 $ 3,387,428 Working capital $ 2,384,994 $ 2,859,578 Total assets $ 3,469,725 $ 4,535,032 Total stockholders' equity $ 2,857,279 $ 3,345,270
© Boston Therapeutics, Inc. All rights reserved.
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