|By Marketwired .||
|August 8, 2014 10:57 AM EDT||
MANCHESTER, NH -- (Marketwired) -- 08/08/14 -- 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 second quarter and six months ended June 30, 2014.
David Platt, Ph.D., Chief Executive Officer, Boston Therapeutics, said, "During the quarter, we experienced several key milestones, including the initiation of a new Phase IIb study of BTI-320 to augment our ongoing Phase IIb study in France. BTI-320 is a new generation of non-systemic Alpha Glucosidase Inhibitor, to reduce post-meal glucose elevation. We expect to report clinical trial results this year."
"Recently, we took steps to sharpen the focus on our core competency as a research and development organization by strengthening our management team with the appointment of Benjamin Rivnay, Ph.D. as Chief Scientist and Eric Hoberman as Manager Clinical Affairs; increasing our focus on R&D programs by adding clinical and regulatory consultants Elena Chekhova, Ph.D. and Tomasz Zastawny, Ph.D., and expanding our Medical Advisory Board to include several key individuals in the field of diabetes such as Larry Ellingson, B.Sc. Pharmacy, Meng Hee Tan, M.D., Philip Raskin, M.D., and Charles M. Clark, Jr., M.D. The Scientific and Medical Advisory Boards report to Rom Eliaz, Ph.D., a member of the Company's Board of Directors."
"Furthermore, we signed an agreement with Patheon to manufacture pharmaceutical-grade BTI-320 tablets as part of the CMC portion of our expected IND filing with the FDA. We anticipate further progress in the third quarter as we continue to grow the Company and work toward the filing of our IND in 2015. We look forward to keeping our investors informed of these developments as they occur."
Business and Clinical Highlights for the Second Quarter 2014 and Subsequent Developments:
- Signed an agreement with pharmaceutical manufacturing company Patheon Inc. (along with Boston Therapeutics' Hong Kong-based strategic partner Advance Pharmaceutical Company) to manufacture pharmaceutical-grade tablets of the Company's lead product candidate BTI-320.
- Entered into a strategic marketing agreement with Benchworks SD, LLC, a leading branding and marketing agency, with the goals of creating brand awareness of SUGARDOWN®.
- Presented an overview of the Company's recent business developments and growth strategy at the SeeThruEquity Microcap Investor Conference and Marcum Microcap Conference.
- Initiated an additional Phase IIb clinical study to assess the efficacy and safety of SUGARDOWN® in 24 patients with Type 2 diabetes taking metformin. Results from both clinical trials are expected this year.
- Appointed Benjamin Rivnay, Ph.D., to serve as the Company's Chief Scientist, a newly created position in which Dr. Rivnay will be responsible for the development of the Company's science and technology.
Financial Results for the Second Quarter and Six Months Ended June 30, 2014:
- Revenue for the second quarter ended June 30, 2014 was $21,391 compared to revenue of $2,118 for the second quarter ended June 30, 2013. The increase was primarily the result of a shipment of SUGARDOWN® to one customer. Revenue for the six months ended June 30, 2014 was $65,218 compared to revenue of $25,454 for the six months ended June 30, 2013. During the first quarter ended March 31, 2013, a $20,600 marketing incentive was granted to one customer for SUGARDOWN® product resulting in a reduction of revenue.
- The gross margin deficit for the second quarter ended June 30, 2014 was ($595) compared to a gross margin deficit of ($5,853) for the second quarter ended June 30, 2013. For the six months ended June 30, 2014 the gross margin deficit was ($11,326) as compared to a gross margin deficit of ($30,454) in the comparable 2013 period. The gross margin deficit for the six months ended June 30, 2014 was primarily related to material and production cost charges and continued fixed fulfillment charges. The improvement in gross margin for the six months ended June 30, 2014 as compared to 2013 is primarily related to the increase in revenue.
- Research and development expense for the three months and six months ended June 30, 2014 was $412,255 and $681,689, respectively, compared to $19,822 and $48,483 for the three month and six months ended June 30, 2013, respectively. The increase for the three and six months is primarily the result of expenses associated with Phase II clinical trial activities for BTI-320.
- Sales and marketing expense for the second quarter ended June 30, 2014 was $84,821 compared to $67,170 for the second quarter ended June 30, 2013. For the six months ended June 30, 2014 sales and marketing expense was $257,556 compared to $148,396 for the six months ended June 30, 2013. The increase for the three and six months is primarily related to the hiring of employees to support the Company's sales and marketing initiatives and the engagement of a healthcare marketing company to market SUGARDOWN®. The Company ended the marketing agreement during the second quarter ended June 30, 2014.
- General and administrative expense for the second quarter and six months ended June 30, 2014 was $708,436 and $1,813,666, respectively, compared to $421,570 and $949,740 for the second quarter and six months ended June 30, 2013, respectively. The $864,000 increase for the six months ended June 30, 2014 is due to an approximate increase of $248,000 in accounting, financial and legal professional fees related to increased legal services, the indemnification of Dr. Platt's legal costs associated with his arbitration, as well as the engagement of a finance professional to manage its accounting and financial reporting matters. In addition, $223,000 is related to non-cash, stock-based compensation primarily related to fully vested options granted during the first quarter ended March 31, 2014. Payroll and payroll related expense increased approximately $144,000 due to salary increases, the institution of an employee medical benefit program and the hiring of a new employee. Consulting and professional services increased approximately $129,000 primarily due to our business development, public relations and investor relations activities. Lastly, approximately $68,000 of the increase is related to severance costs associated with the resignation of the Company's former President, Kenneth A. Tassey, Jr., effective June 30, 2014.
- Net loss for the second quarter ended June 30, 2014 was $1,211,095 or $0.03 per share, compared with a net loss of $519,238 or $0.03 per share in the prior year's second quarter. As of June 30, 2014, there were 38.4 million weighted average shares outstanding, compared with 19.3 million weighted average shares outstanding as of June 30, 2013. Net loss for the six months ended June 30, 2014 was $2,777,518 or $0.07 cents per share, compared with a net loss of 1,186,660 or $0.06 per share for the six months ended June 30, 2013. For the six months ended June 30, 2014 there were 37.9 million shares outstanding compared with 19.1 million for the six months ended June 30, 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 fourth quarter of 2014. We plan to seek additional capital through private placements and public offerings of the Company's 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 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, Inc., 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 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. Condensed Statements of Operations (Unaudited) Three Months Ended Six Months Ended June 30, June 30, ------------------------ ------------------------ 2014 2013 2014 2013 ----------- ----------- ----------- ----------- Revenue $ 21,391 $ 2,118 $ 65,218 $ 25,454 Cost of goods sold 21,986 7,971 76,544 55,908 ----------- ----------- ----------- ----------- Gross margin (deficit) (595) (5,853) (11,326) (30,454) Operating expenses: Research and development 412,255 19,822 681,689 48,483 Sales and marketing 84,821 67,170 257,556 148,396 General and administrative 708,436 421,570 1,813,666 949,740 ----------- ----------- ----------- ----------- Total operating expenses 1,205,512 508,562 2,752,911 1,146,619 Operating loss (1,206,107) (514,415) (2,764,237) (1,177,073) Interest expense (4,940) (4,823) (9,668) (9,587) Other income (expense) 48 - (2,892) - Foreign currency loss (96) - (721) - ----------- ----------- ----------- ----------- Net loss $(1,211,095) $ (519,238) $(2,777,518) $(1,186,660) =========== =========== =========== =========== Net loss per share - basic and diluted $ (0.03) $ (0.03) $ (0.07) $ (0.06) Weighted average shares outstanding basic and diluted 38,397,142 19,328,286 37,924,149 19,104,565 =========== =========== =========== =========== Boston Therapeutics, Inc. Balance Sheet Data June 30, December 31, 2014 2013 ------------- ------------- Cash and cash equivalents $ 1,508,790 $ 3,387,428 Working capital $ 1,317,107 $ 2,859,578 Total assets $ 2,565,764 $ 4,535,032 Total stockholders' equity $ 1,773,939 $ 3,345,270
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