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Synergy Pharmaceuticals Reports Second Quarter and First Half 2014 Financial ResultsNEW YORK --(Business Wire)-- Synergy (News - Alert) Pharmaceuticals Inc. (NASDAQ:SGYP), today reported its financial results and business update for the three and six months ended June 30, 2014. Key Development Highlights:
"We are pleased with the clinical milestones achieved over the last several months along with the positive interactions with the FDA," said Dr. Gary S. Jacob, Chairman and CEO of Synergy. "We remain focused on the successful execution of our clinical programs as we enter the second half of this year and look to start our second registration program with plecanatide in IBS-C and continue to advance the ongoing pivotal phase 3 CIC trials toward our anticipated NDA filing next year." Synergy's cash, cash equivalents and available-for-sale securities balance as of June 30, 2014 was $51.2 million as compared to $68.1 million on December 31, 2013. During the six months ended June 30, 2014, net cash provided by financing activities was $22.2 million, as compared to $89.2 million during the six months ended June 30, 2013. Net cash used in operating activities was $39.5 million during the six months ended June 30, 2014, as compared to $28.6 million during the six months ended June 30, 2013. Net loss for the three months ended June 30, 2014 was $25.9 million or $0.28 per share, as compared to a net loss of $10 million, or $0.11 per share, for the quarter ended June 30, 2013. During the three months ended June 30, 2014, non-cash expense items, principally a change in fair value of derivative instruments and stock based compensation expense, totaled approximately net loss of $0.2 million, whereas such items in the three months ended June 30, 2013 totaled a net gain of $0.9 million, or a net gain of $0.01 per share. Net loss for the six months ended June 30, 2014 was $42.2 million or $0.45 per share, as compared to a net loss of $28.7 million, or $0.36 per share, for the six months ended June 30, 2013. During the six months ended June 30, 2014, non-cash expense items, principally a change in fair value of derivative instruments and stock based compensation expense, totaled approximately net loss $1.3 million or $0.01 per share, whereas such items in the six months ended June 30, 2013 totaled net loss of approximately $1.5 million, or $0.02 per share. Synergy had approximately 94.1 million common shares issued and outstanding at June 30, 2014. About Synergy Pharmaceuticals Inc. Synergy Pharmaceuticals Inc. is a biotechnology company focused on the research and development of novel therapies based on the naturally occurring human hormone, uroguanylin, for the treatment of gastrointestinal (GI) diseases and disorders. Uroguanylin is a natural hormone produced by humans in the small intestine and plays a key role in regulating the normal functioning of the digestive tract through its activity on the guanylate cyclase-C (GC-C) receptor. The GC-C receptor is known to be a primary source for stimulating a variety of beneficial physiological responses. Synergy has created two unique analogs of uroguanylin - plecanatide and SP-333 - designed to mimic the natural hormone's activity on the GC-C receptor and target a variety of GI conditions. Plecanatide is in two pivotal phase 3 clinical trials for chronic idiopathic constipation and has successfully completed a phase 2b study for irritable bowel syndrome with constipation. SP-333 is in phase 2 development for opioid-induced constipation and is also being explored for ulcerative colitis. For more information, please visit www.synergypharma.com. Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "planned," "believe," "forecast," "estimated," "expected," and "intend," among others. These forward-looking statements are based on Synergy's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Synergy's Form 10-K for the year ended December 31, 2013 and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Synergy does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances; and thus you should not unduly rely on these statements.
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