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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 |
In the "Ensuring a Strong Financial Foundation" section, first sentence of fifth bullet point should read: Cash and cash equivalents were approximately $61.2 million at the end of the second quarter (instead of Cash and cash equivalents were approximately $61.2 million at the end of the first quarter).
The corrected release reads:
SYNERGY PHARMACEUTICALS REPORTS SECOND QUARTER 2018 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 three months ended June 30, 2018.
"The Synergy team continues to demonstrate strong execution towards our 2018 key business priorities of optimizing the value of TRULANCE, ensuring a strong financial foundation and continuing to explore all business development opportunities," said Troy Hamilton, Chief Executive Officer of Synergy Pharmaceuticals Inc. "In terms of optimizing TRULANCE, we reported strong quarter-over-quarter growth with net sales increasing 43% in the second quarter. In addition, today we announced a major coverage win with Express Scripts, helping us to enhance and expand our current coverage, improve patient access and support sales growth. Lastly, since the beginning of the year we've successfully executed on two ex-US licensing transactions for TRULANCE as well as a collaboration with the National Cancer Institute (NCI) to advance development of our second pipeline asset, dolcanatide, underscoring our commitment to pursuing a wide variety of value-enhancing strategic and business development opportunities. While we are very pleased with these partnerships, we are still actively assessing other potential opportunities that align with our ultimate objective of maximizing value for Synergy shareholders. We remain committed to being as transparent as possible during this ongoing strategic review and expect to provide another update in the near term. I want to thank the entire Synergy team, our customers and shareholders for their continued support during this dynamic period."
“We were pleased with solid topline growth of over 40% in the second quarter versus the prior quarter, resulting in $20.8 million in total net sales for the six months ended June 30, 2018," said Gary Gemignani, EVP and Chief Financial Officer of Synergy Pharmaceuticals Inc. "As we move into the second half of the year, we will continue to balance our commitment to topline growth with the efficient management of our bottom line, as highlighted by the 44% reduction in total adjusted operating expenses we achieved year-over-year. We are evaluating opportunities to further optimize our operating efficiencies and intend to update our 2018 total adjusted OPEX guidance as part of our ongoing strategic review.”
Second Quarter 2018 and Recent Highlights
Optimizing the Value of TRULANCE
Ensuring a Strong Financial Foundation
Financial Results
Exploring All Strategic and Business Development Opportunities
Collaborations & Partnerships
2018 Financial Guidance / Strategic Review Update
About Synergy Pharmaceuticals
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 around analogs of uroguanylin, a naturally occurring human GI peptide, for the treatment of GI diseases and disorders. Synergy’s proprietary GI platform includes one commercial product TRULANCE® (plecanatide) and a second product candidate - dolcanatide. For more information, please visit www.synergypharma.com.
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 two 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.
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 TRULANCE®
TRULANCE® (plecanatide) is a once-daily tablet approved for adults with CIC or IBS-C. With the exception of a single amino acid substitution for greater binding affinity, TRULANCE is structurally identical to uroguanylin, a naturally occurring and endogenous human GI peptide. Uroguanylin activates GC-C receptors in a pH-sensitive manner primarily in the small intestine, stimulating fluid secretion and maintaining stool consistency necessary for regular bowel function.
Indications and Usage
TRULANCE (plecanatide) 3 mg tablets is indicated in adults for the treatment of Chronic Idiopathic Constipation (CIC) and Irritable Bowel Syndrome with Constipation (IBS-C).
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 also see the full Prescribing Information, including Box Warning, for additional risk information.
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, 2017 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
(unaudited)
($ in thousands) June 30, 2018 December 31, 2017 Assets Cash and cash equivalents $ 61,233 $ 136,986 Accounts receivable 8,511 6,491 Inventories 17,609 17,214 Prepaid expenses and other current assets 7,772 4,469 Total Current Assets 95,125 165,160 Other assets 1,480 1,446 Total Assets $ 96,605 $ 166,606 Liabilities and Stockholders' (Deficit) Total Current Liabilities $ 33,598 $ 38,147 Senior convertible notes, net 17,657 17,302 Long term debt, net 100,327 98,660 Derivative financial instruments – warrants 9,334 17,582 Other long-term liabilities 379 433 Total Liabilities 161,295 172,124 Total Stockholders’ Deficit (64,690 ) (5,518 ) Total Liabilities and Stockholders’ Deficit $ 96,605 $ 166,606Condensed Consolidated Statement of Operations
($ in thousands except share and per share data)
(unaudited)
Three Months Ended June 30, 2018
Three Months Ended June 30, 2017
Six Months Ended June 30, 2018
Six Months Ended June 30, 2017
Net sales $ 12,254 $ 2,314 $ 20,840 $ 2,412 Cost of goods sold 3,885 1,643 7,589 3,279 Gross profit 8,369 671 13,251 (867 ) Costs and Expenses: Research and development 2,844 22,069 6,236 40,470 Selling, general and administrative 34,615 52,185 74,760 94,973 Total Operating Expenses 37,459 74,254 80,996 135,443 Loss from Operations (29,090 ) (73,583 ) (67,745 ) (136,310 ) Other Income/(Expense): Interest expense, net (3,205 ) (345 ) (6,328 ) (1,135 ) State R&D tax credits — — 30 — Debt conversion expense — — — (1,209 ) Change in fair value of derivative instruments - warrants 2,604 39 8,248 161 Total Other Income/(Expense) (601 ) (306 ) 1,950 (2,183 ) Net Loss $ (29,691 ) $ (73,889 ) $ (65,795 ) $ (138,493 ) Net Loss per Common Share, Basic and Diluted $ (0.12 ) $ (0.33 ) $ (0.27 ) $ (0.63 ) Weighted Average Common Shares Outstanding 246,990,080 224,948,622 246,827,974 220,269,223Synergy Pharmaceuticals Inc.
Non-GAAP Financial Measures
Adjusted research and development expenses, adjusted selling, general and administrative expenses, and adjusted total operating expenses are not measures of financial performance under accounting principles generally accepted in the United States (“GAAP”) and should not be construed as substitutes for, or superior to, GAAP research and development expenses, GAAP selling, general and administrative expenses and GAAP total operating expenses as a measure of financial performance. However, management uses both GAAP financial measures and the disclosed non-GAAP financial measures internally to evaluate and manage the Company's operations and to better understand its business. Further, management believes the addition of non-GAAP financial measures provides meaningful supplementary information to, and facilitates analysis by, investors in evaluating the Company's financial performance, results of operations and trends. The Company's calculations of adjusted research and development expenses, adjusted selling, general and administrative expenses and adjusted operating expenses, may not be comparable to similarly designated measures reported by other companies, since companies and investors may differ as to what type of events warrant adjustment.
The following table reconciles reported research and development expenses to adjusted research and development expenses (adjusted R&D):
(Unaudited; $ in thousands)
Three Months Ended June 30, 2018
Three Months Ended June 30, 2017
Research and development expenses $ 2,844 $ 22,069 Adjusted to deduct: Stock based compensation expense 504 (80 ) Adjusted research and development expenses $ 2,340 $ 22,149The following table reconciles reported selling, general and administrative expenses to adjusted selling, general and administrative expenses (adjusted SG&A):
(Unaudited; $ in thousands)
Three Months Ended June 30, 2018
Three Months Ended June 30, 2017
Selling, general and administrative expenses $ 34,615 $ 52,185 Adjusted to deduct: Stock based compensation expense 2,924 13,378 Adjusted selling, general and administrative expenses $ 31,691 $ 38,807The following table reconciles reported total operating expenses to adjusted operating expenses (adjusted OPEX):
(Unaudited; $ in thousands)
Three Months Ended June 30, 2018
Three Months Ended June 30, 2017
Total operating expenses $ 37,459 $ 74,254 Adjusted to deduct: Stock based compensation expense 3,428 13,298 Adjusted operating expenses $ 34,031 $ 60,956
View source version on businesswire.com: https://www.businesswire.com/news/home/20180807005950/en/
Company:Synergy Pharmaceuticals Inc.Gem Hopkins, 212-584-7610VP, Investor Relations and Corporate Communicationsghopkins@synergypharma.com
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