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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 |
Please replace the release, dated March 1, 2017, with the following corrected version due to multiple revisions in the Financial Results bullets and financial tables.
The corrected release reads:
SYNERGY PHARMACEUTICALS REPORTS FOURTH QUARTER AND FULL YEAR 2016 FINANCIAL RESULTS AND BUSINESS UPDATE
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 full year and the three months ended December 31, 2016.
“The approval of TRULANCE™ (plecanatide) in the United States for the treatment of adults with chronic idiopathic constipation was a tremendous event not just for Synergy, but also for the millions of patients with CIC who have been in need of a new therapeutic option,” said Gary S. Jacob, PhD, Chairman and Chief Executive Officer of Synergy Pharmaceuticals Inc. “I am pleased with the progress our team has made implementing a strong and compelling commercial plan, a robust high quality supply chain, and ensuring that the Synergy organization, healthcare providers and payers, are well prepared for the launch of TRULANCE this month. In addition, we are continuing our efforts to bring TRULANCE to patients with irritable bowel syndrome with constipation, as we remain on-track to file a supplemental new drug application (sNDA) this month.”
“Together with the approval of TRULANCE, the fourth quarter of 2016 and beginning of 2017 were marked by several key accomplishments, including positive top-line results in two Phase 3 trials of TRULANCE in IBS-C which will support the sNDA filing and the recent publication of our Phase 3 CIC data in the American Journal of Gastroenterology. We’ve also strengthened our balance sheet and enhanced our strategic options as we completed a $125 million financing, continued to reduce our convertible debt and successfully eliminated restrictive covenants associated with that debt. These achievements put Synergy in an excellent position for future growth as we begin to commercialize our first product, TRULANCE.”
Fourth Quarter 2016 and Recent Highlights
TRULANCE™ (plecanatide) CIC Update
TRULANCE IBS-C Development Update
TRULANCE Launch Update
We are focused on three key strategic imperatives to achieve our objective of ensuring that TRULANCE is ready for launch this quarter:
Product Readiness
Market and Brand Readiness
Organizational Readiness
Financial Results
Indications and Usage
TRULANCE is a guanylate cyclase-C (GC-C) agonist indicated in adults for the treatment of chronic idiopathic constipation (CIC).
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
Trulance™ is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile mice administration of a single oral dose of plecanatide caused deaths due to dehydration. Use of Trulance should be avoided in patients 6 years to less than 18 years of age. The safety and efficacy of Trulance have not been established in pediatric patients less than 18 years of age.
Contraindications
Warnings and Precautions
Risk of Serious Dehydration in Pediatric Patients
Diarrhea
Adverse Reactions
Please click here for Full Prescribing Information.
About Chronic Idiopathic Constipation (CIC)
CIC affects approximately 14 percent of the global population, disproportionately affecting women and older adults. People with CIC have persistent symptoms of difficult-to-pass and infrequent bowel movements. In addition to physical symptoms including abdominal bloating and discomfort, CIC can adversely affect an individual’s quality of life, including increasing stress levels and anxiety.
About Irritable Bowel Syndrome with Constipation (IBS-C)
Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by recurrent abdominal pain and associated with 2 or more of the following: related to defecation, associated with a change in the frequency of stool, or associated with a change in the form (appearance) of the stool. IBS can be subtyped by the predominant stool form: constipation (IBS-C), diarrhea (IBS-D), or mixed (IBS-M). Those within the IBS-C subtype experience hard or lumpy stools more than 25 percent of the time they defecate, and loose or watery stools less than 25 percent of the time. It is estimated that the prevalence of IBS-C in the U.S. adult population is approximately 4 to 5 percent, although this number may vary as patients often fluctuate between the three subtypes of IBS.
About TRULANCE™
TRULANCE™ (plecanatide) is a once-daily tablet approved for adults with CIC and is being evaluated for IBS-C. With the exception of a single amino acid, TRULANCE is structurally identical to uroguanylin, a naturally occurring and endogenous human GI peptide. Uroguanylin is thought to act in a pH-sensitive manner, targeting GC-C receptors primarily in the small intestine coinciding with areas of fluid secretion.
About Synergy Pharmaceuticals Inc.
Synergy is a biopharmaceutical company focused on the development and commercialization of novel GI therapies. The company has pioneered discovery, research and development efforts on analogs of uroguanylin, a naturally occurring and endogenous human GI peptide, for the treatment of GI diseases and disorders. Synergy’s proprietary uroguanylin analog platform includes one commercial product TRULANCE (plecanatide) and a second lead product candidate - dolcanatide. 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, 2016 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.
Consolidated Balance Sheets
($ in thousands) December 31, 2016 December 31, 2015 AssetsCash, cash equivalents and available-for-sale securities
$ 82,387 $ 111,750 Inventories 5,640 — Prepaid expenses and other current assets 889 3,305 Total Current assets 88,916 115,055 Other assets 936 874 Total assets $ 89,852 $ 115,929 Liabilities and Stockholders' Equity/(Deficit) Total Current Liabilities $ 29,430 $ 19,579Senior convertible notes, net
22,665 151,241 Derivative financial instruments – warrants 216 322 Total Liabilities 52,311 171,142 Total Stockholders’ Equity/(Deficit) 37,541 (55,213 ) Total Liabilities and Stockholders' Equity/(Deficit) $ 89,852 $ 115,929Synergy Pharmaceutical Inc.
Consolidated Statement of Operations
($ in thousands except share and per share data)
Three
Months
Ended
December
31,
2016
Three
Months
Ended
December
31,
2015
Year Ended
December
31,
2016
Year Ended
December
31,
2015
Revenues $ — $ — $ — $ — Costs and Expenses: Research and development 17,166 19,881 89,562 78,028 Selling, general and administrative 25,232 7,066 55,724 21,794 Loss from Operations (42,398 ) (26,947 ) (145,286 ) (99,822 )Other Loss/Income:
Interest and investment expense, net (3,007 ) (3,469 ) (13,390 ) (17,284 ) Debt conversion expense(14,543
)
— (40,158 ) —State R&D tax credits
126
—
121
—
Change in fair value of financial instruments (45 ) (30 ) 106 (394 ) Total Other Loss (17,469 ) (3,499 ) (53,321 ) (17,678 ) Net Loss $ (59,867 ) $ (30,446 ) $ (198,607 ) $ (117,500 ) Net Loss per Common Share, Basic and Diluted $ (0.31 ) $ (0.27 ) $ (1.21 ) $ (1.11 ) Weighted Average Common Shares Outstanding 190,093,786 113,678,306 164,437,548 105,570,960
View source version on businesswire.com: http://www.businesswire.com/news/home/20170301006542/en/
Synergy Pharmaceuticals Inc.Gem Hopkins, 212-584-7610VP, Investor Relations and Corporate Communicationsghopkins@synergypharma.com
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