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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, 2017. Synergy will host a conference call and webcast at 4:30 p.m. Eastern Time on Thursday, September 7, 2017 to discuss its corporate and financial strategy, and provide a general business update. Further details about this conference call can be found below.
“The first half of 2017 was a truly transformative period for Synergy, as we transitioned into a commercial organization and launched our first product, TRULANCE, in the U.S. for the treatment of adults with chronic idiopathic constipation (CIC),” said Gary S. Jacob, Ph.D., Chairman and CEO of Synergy Pharmaceuticals Inc. “We are pleased with the execution of our commercial strategy, and the strong initial demand for TRULANCE, reinforcing the need for new treatment options for patients suffering from CIC. And we are making significant progress in ensuring broad access to TRULANCE, highlighted by a number of favorable early decisions from key national payers.”
“During the second quarter, we also made significant progress towards broadening the TRULANCE label with the FDA acceptance of our sNDA for the treatment of adults with IBS-C,” continued Dr. Jacob. “These achievements put Synergy on excellent footing as we look to drive further long-term growth and value for the TRULANCE brand.”
Gary Gemignani, Synergy’s EVP and Chief Financial Officer added, “We believe Synergy is well-positioned to efficiently capitalize on the substantial opportunity we have in front of us with our core, high value asset, TRULANCE. We are currently evaluating financing options that will provide flexibility and allow us to continue to execute on our business objectives, which we are confident will ultimately maximize shareholder value. We are pleased with our progress on this front and look forward to providing further updates in the near-term.”
Second Quarter 2017 and Recent Highlights
TRULANCE (plecanatide) Commercial Launch Update
Driving Awareness of TRULANCE and Stimulating Trial and Adoption
Ensuring Market Access
Sales Force Update
TRULANCE IBS-C Development Update
Conference Call on Thursday, September 7, 2017:
Synergy will host a conference call at 4:30 p.m. Eastern Time on Thursday, September 7, 2017 to discuss its corporate and financial strategy, and provide a general business update. The dial-in number to access the call is (877) 407-3987 (U.S. and Canada) or (412) 902-0039 (International). To access the webcast, please visit the Investors section of Synergy's website at www.synergypharma.com.
A taped replay of the conference call will also be available beginning approximately 2 hours after the call's conclusion, and will remain available through September 21, 2017. The replay may be accessed by dialing (877) 660-6853 (U.S. and Canada) or (201) 612-7415 (International) and entering conference ID number 13668774. A replay of the webcast will also be available on the Investors section of Synergy's website at www.synergypharma.com.
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 GI platform includes one commercial product TRULANCE and a second lead product candidate, dolcanatide. For more information, please visit www.synergypharma.com.
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 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.
TRULANCE Important Safety Information
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.
Warnings and Precautions
Risk of Serious Dehydration in Pediatric Patients
Please click here for Full Prescribing Information.
This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Synergy Pharmaceuticals Inc. under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These statements may be identified by the use of forward-looking words such as "anticipate," "planned," "believe," "forecast," "estimated," "expected," and "intend," among others. 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, the development, launch, introduction and commercial potential of TRULANCE; growth and opportunity, including peak sales and the potential demand for TRULANCE, as well as its potential impact on applicable markets; market size; 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; dependence upon third parties; our financial performance and results, including the risk that we are unable to manage our operating expenses or cash use for operations, or are unable to commercialize our products, within the guided ranges or otherwise as expected; 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 most recent periodic reports filed with the Securities and Exchange Commission, including Synergy’s Form 10-K for the year ended December 31, 2016. 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 except as required by law.
Synergy Pharmaceutical Inc.
Condensed Consolidated Balance Sheets
|($ in thousands)||
June 30, 2017
|December 31, 2016|
|Cash and cash equivalents||$||81,960||$||82,387|
|Prepaid expenses and other current assets||8,368||889|
|Total Current assets||103,963||88,916|
|Liabilities and Stockholders' Equity|
|Total Current Liabilities||$||44,581||$||29,430|
|Senior Convertible Notes, net||16,948||22,665|
|Derivative financial instruments – warrants||55||216|
|Total Stockholders’ Equity||43,315||37,541|
|Total Liabilities and Stockholders' Equity||$||104,899||$||89,852|
Condensed Consolidated Statement of Operations
($ in thousands except share and per share data)
|Cost of goods sold||2,890||—||4,695||—|
|Costs and Expenses:|
|Research and development||22,314||26,611||41,443||47,786|
|Selling, general and administrative||50,693||10,249||92,584||16,624|
|Loss from Operations||(73,583||)||(36,860||)||(136,310||)||(64,410||)|
|Interest and investment expense, net||(345||)||(1,673||)||(1,135||)||(8,709||)|
|Debt conversion expense||—||—||(1,209||)||(25,615||)|
|Change in fair value of derivative financial instruments - warrants||39||(23||)||161||237|
|Total Other Expenses||(306||)||(1,696||)||(2,183||)||(34,087||)|
|Net Loss per Common Share, Basic and Diluted||$||(0.33||)||$||(0.23||)||$||(0.63||)||$||(0.69||)|
|Weighted Average Common Shares Outstanding||224,948,622||168,127,144||220,269,223||143,017,970|
Synergy Pharmaceuticals Inc.
Gem Hopkins, 212-584-7610
VP, Investor Relations and Corporate Communications
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