Synergy Pharmaceuticals Inc fka SGYPQ

[Opti Mist]

Synergy Pharma misses by $0.07
May 10, 2017 5:19 PM ET|About: Synergy Pharmaceuticals, ... (SGYP)|By: Jignesh Mehta, SA News Editor
Synergy Pharma (NASDAQ:SGYP): Q1 EPS of -$0.30 misses by $0.07.
Revenue of $0.1M
Press Release at: https://seekingalpha.com/pr/16829397-synergy-pharmaceuticals-reports-first-quarter-2017-financial-results-business-update

Synergy Pharmaceuticals Reports First Quarter 2017 Financial Results and Business Update
Wed May 10, 2017 4:54 PM|Business Wire|About: SGYP
Received FDA Approval of TRULANCE™ (plecanatide) for the Treatment of Adults with Chronic Idiopathic Constipation (CIC); Initiated Promotional Efforts for TRULANCE in March 2017
Submitted Supplemental New Drug Application (sNDA) for TRULANCE for the Treatment of Adults with Irritable Bowel Syndrome with Constipation (IBS-C)
Extended TRULANCE Exclusivity Protection with the Issuance of Three New Patents
Highlighted New Data for TRULANCE at Digestive Disease Week (DDW) 2017
NEW YORK--(BUSINESS WIRE)-- Synergy Pharmaceuticals Inc. (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 March 31, 2017.
“The first three months of this year have been among the most significant in the company’s history and are highlighted by several important milestones that demonstrate our continued commitment to scientifically driven innovation and providing novel treatment options for patients and healthcare providers,” said Gary S. Jacob, PhD, Chairman and Chief Executive Officer of Synergy Pharmaceuticals Inc. “Following the early FDA approval of TRULANCE for the treatment of adults with CIC in January, our commercial team initiated TRULANCE promotion on March 20th and we are very pleased with the encouraging feedback from patients and key prescribers, as well as the early uptake of TRULANCE after only a few weeks of marketing. In addition, we have made tremendous progress moving conversations forward with payers and will continue all efforts to increase access for patients. While it is still early in the launch, everything we are seeing reinforces the significant opportunity for TRULANCE to treat adults with CIC over the coming years. Looking ahead, we will continue to focus on the TRULANCE launch in CIC, while working with the FDA to broaden the product label with the IBS-C indication. We look forward to updating you on our progress in the coming months.”
Gary Gemignani, Synergy’s newly appointed EVP and Chief Financial Officer added, “I am honored to have joined Synergy at this pivotal juncture where I see significant opportunity to capitalize on the strong foundation we have in place to drive further growth. Synergy controls 100% of the worldwide rights to TRULANCE, a high value asset that is now generating revenues and has secured a long lifespan that we will be able to maximize. We remain focused on having a disciplined approach to capital allocation to support appropriate investments that will ensure the long-term success of TRULANCE. I look forward to working with Gary and the team as we continue to pursue growth, strengthen our balance sheet and drive shareholder value.”
First Quarter 2017 and Recent Highlights
TRULANCE™ (plecanatide) CIC Update
In January 2017, the United States Food and Drug Administration (FDA) approved TRULANCE for the treatment of adults with CIC. In clinical trials, TRULANCE helped improve stool consistency and provide more regular bowel movements. TRULANCE is the only prescription medication for CIC that can be taken once-daily, with or without food, at any time of the day. In addition, TRULANCE is the only prescription medication for CIC available in a unique calendar pack that was preferred by the majority of patients versus a traditional pill bottle.
TRULANCE IBS-C Development Update
In March 2017, we submitted a sNDA for TRULANCE for the treatment of adults with IBS-C. We expect a 10-month review period from the submission date of March 24, 2017. The application is based on data from two of the largest Phase 3 IBS-C clinical trials to date, which evaluated more than 2,100 patients. In both 12-week studies, TRULANCE met the primary endpoint and showed statistical significance in the percentage of patients who were Overall Responders compared to placebo. The FDA has defined an Overall Responder as a patient who achieves ≥ 30% reduction in worst abdominal pain and an increase of ≥ 1 complete spontaneous bowel movement (CSBM) from baseline, in the same week, for at least 50% of the 12 treatment weeks.
TRULANCE IP Update
On April 12, 2017, we announced that the United States Patent and Trademark Office (USPTO) has issued three new patents covering TRULANCE. The first patent relates to the method for manufacturing TRULANCE and will expire March 1, 2032. The two other patents relate to formulations and methods of using TRULANCE for treating chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) at 3mg or 6 mg dose; both of these patents will expire September 15, 2031.
TRULANCE Commercial Launch Update
Driving Awareness of TRULANCE and Stimulating Trial and Adoption
Our sales force of approximately 250 is fully deployed across the U.S. and now educating approximately 27,000 high prescribers about TRULANCE.
The targeted prescriber base includes gastroenterologists, primary care physicians, nurse practitioners and physician assistants that currently account for approximately 70% of the total branded prescriptions, according to QuintilesIMS.
To date, our sales force has reached over 80% of the prescribers in the top three deciles.
According to QuintilesIMS analog research, we are exceeding expectations in terms of penetration and adoption curves with top decile prescribers after one month of launch.
Since launch, approximately 50% of TRULANCE prescriptions are coming from other branded prescription products and 50% are new patients.
Over 300,000 7-day sample packs of TRULANCE have been distributed to the field force, to-date.
Initiated peer-to-peer educational programs with approximately 140 gastroenterologists now educating local gastroenterologists, primary care physicians and other health care professionals on patient, disease and product-specific information to enable appropriate use of TRULANCE.
Launched a comprehensive print and digital media plan to drive awareness of TRULANCE and stimulate trial and adoption among target prescribers.
Presented new TRULANCE data and insights from the BURDEN-CIC study at DDW 2017.
Presented six abstracts, including one late-breaker oral presentation highlighting TRULANCE data from the two Phase 3 IBS-C trials. Two of the abstracts were recognized by the American Gastroenterology Association (AGA) as Posters of Distinction.
Presented new insights from the BURDEN-CIC study that examined patient and physician perceptions and experiences with CIC. The results highlight the condition’s impact and show the need for additional CIC treatment options.
Ensuring Market Access
To-date, approximately 60% of adult CIC patients with commercial insurance have unrestricted access to TRULANCE.
The TRULANCE “Savings-to-Go” program helps to ensure an average copay of $25 per prescription for over 95% of patients .......