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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Synergy Pharmaceuticals, Inc. | NASDAQ:SGYP | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.03 | 0.0488 | 0.049 | 0 | 01:00:00 |
Synergy Pharmaceuticals Inc. (NASDAQ:SGYP), a biopharmaceutical company focused on the development and commercialization of novel gastrointestinal (GI) therapies, today reported its financial results and business update for the three months ended June 30, 2016.
“Our exciting transformation from a purely research and development company into a fully integrated commercial organization continues unabated as we successfully advance and execute against our key strategic priorities,” said Gary S. Jacob, Chairman and Chief Executive Officer of Synergy Pharmaceuticals Inc. “These priorities are guided by our overarching mission to optimize the value of plecanatide and maximize shareholder value.”
“The rest of 2016 promises to be an exciting time as we expect top-line results in our two phase 3 IBS-C trials with plecanatide. We are especially pleased with our ongoing dialogue with the FDA, including the results of our recent mid-cycle review meeting. Building the right commercial strategy and having the ability to successfully execute on the launch plan requires a strong team and we are fortunate to be attracting talented leaders with relevant experience from across our industry. I am very proud of the Synergy organization which is committed to a successful launch of plecanatide and bringing this important new treatment option to patients suffering from CIC and IBS-C,” added Dr. Jacob.
Second Quarter 2016 and Recent Highlights
Research & Development
Plecanatide CIC Development Update
Plecanatide IBS-C Development Update
Dolcanatide UC Development Update
Commercial Planning & Launch Preparation
Our commercial, medical affairs and technical operations teams are continuing to execute on our key strategic imperatives to ensure launch readiness, including the following major initiatives:
Product Readiness
Market/Brand Readiness
Organizational Readiness
Financial Results
About Synergy Pharmaceuticals Inc.
Synergy is a biopharmaceutical company focused on the development and commercialization of novel gastrointestinal (GI) therapies. The company has pioneered discovery, research and development efforts on analogs of uroguanylin, a naturally occurring human GI peptide, for the treatment of functional GI disorders and inflammatory bowel disease. Synergy is developing and retains 100% worldwide rights to its proprietary uroguanylin analog technology platform that includes two lead product candidates - plecanatide and dolcanatide. Plecanatide is Synergy's first uroguanylin analog currently being evaluated for use as a once-daily tablet for the treatment of CIC and IBS-C. Dolcanatide is Synergy's second uroguanylin analog currently 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 Annual Report on Form 10-K for the year ended December 31, 2015 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.
Synergy Pharmaceutical Inc. Condensed Consolidated Balance Sheets ($ in thousands) June 30, 2016(unaudited) December 31, 2015 Assets Cash, cash equivalents and available for sale securities $ 141,219 $ 111,750 Prepaid expenses and other current assets 4,266 3,305 Total Current assets 145,485 115,055 Other assets 1,067 874 Total assets $ 146,552 $ 115,929 Liabilities and Stockholders' Equity/(Deficit) Total Current Liabilities $ 23,127 $ 19,579 Senior Convertible Notes, net 75,818 151,241 Derivative financial instruments – warrants 85 322 Total Liabilities 99,030 171,142 Total Stockholders’ Equity/(Deficit) 47,522 (55,213 ) Total Liabilities and Stockholders' Equity/(Deficit) $ 146,552 $ 115,929Condensed Consolidated Statement of Operations
($ in thousands except share and per share data)
(unaudited)Three Months Ended June 30,
Three Months Ended June 30,
Six Months Ended June 30,
Six Months Ended June 30,
2016 2015 2016 2015 Revenues $ — $ — $ — $ — Costs and Expenses: Research and development 26,611 19,525 47,786 37,723 Selling, general and administrative 10,249 7,394 16,624 12,000 Loss from Operations (36,860 ) (26,919 ) (64,410 ) (49,723 ) Other Loss: Interest and investment expense, net (1,673 ) (5,207 ) (8,709 ) (9,524 ) Debt conversion expense — — (25,615 ) — Change in fair value of financial instruments (23 ) (1,542 ) 237 (1,810 ) Total Other Loss (1,696 ) (6,749 ) (34,087 ) (11,334 ) Net Loss $ (38,556 ) $ (33,668 ) $ (98,497 ) $ (61,057 ) Net Loss per Common Share, Basic and Diluted $ (0.23 ) $ (0.34 ) $ (0.69 ) $ (0.62 ) Weighted Average Common Shares Outstanding 168,127,144 100,343,637 143,017,970 98,523,696
View source version on businesswire.com: http://www.businesswire.com/news/home/20160808006264/en/
Company:Synergy Pharmaceuticals Inc.Gem Hopkins, 212-584-7610VP, Investor Relations and Corporate Communicationsghopkins@synergypharma.com
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