- 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
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 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 with commercial insurance.
- The TRULANCE Access Support Services
Program provides healthcare providers and patients additional
assistance for certain managed care plans that require prior
authorizations.
- Medicare Part D and Medicaid
discussions are ongoing and progressing well.
Activating and Supporting the Rx Ready Patient
- Launched consumer media campaigns to
support the product launch and drive awareness of the TRULANCE
brand and the current unmet needs of patients with CIC.
- TRULANCE Branded Campaign:
- Point-of-care promotion: targeting
~20,000 offices.
- Web sponsorships and display
advertisements generated over 36 million impressions, to-date.
- Search engine marketing initiatives
generated over 65,000 clicks, to-date.
- Over 100,000 visits to the Trulance.com
consumer site, to-date.
- “Confront Constipation” Campaign:
- Disease awareness initiative designed
to increase the understanding and improve the dialogue between
patients, prescribers, and other health care providers on managing
CIC.
- Campaign has generated 28 original
media placements and over 300 million media impressions,
to-date.
- Over 60,000 downloads of the Poop Troop
emoji keyboard, to-date.
Financial Results
- As of March 31, 2017, we had
approximately $139.3 million of cash and cash equivalents on hand
as compared to approximately $82.4 million of cash and cash
equivalents as of December 31, 2016.
- Net cash used in operating activities
was $63.5 million in the three months ended March 31, 2017, as
compared to $27.6 million in the three months ended March 31, 2016.
This increase is primarily attributable to the buildout of the
commercial organization and costs related to the launch of
TRULANCE, including the building of inventory.
- We had net deferred revenues of $4.3
million during the three months ended March 31, 2017 as we first
began distributing our product in March of 2017. We expect that
these revenues will be recognized in future periods.
- Net sales in the first quarter of 2017
were approximately $0.1 million as we first began distributing our
product in late March of 2017.
- Cost of goods sold in the first quarter
of 2017 was approximately $1.8 million.
- Research and development expenses in
the first quarter of 2017 were approximately $19.1 million, as
compared to $21.2 million in the first quarter of 2016. This
decrease in research and development expenses was due primarily to
lower spending on CIC clinical studies.
- Selling, general and administrative
expenses were approximately $41.9 million in the first quarter of
2017, as compared to approximately $6.4 million in the first
quarter of 2016. This increase is primarily attributable to the
buildout of the commercial organization and costs related to the
launch of TRULANCE.
- On February 6, 2017, we closed on a
registered direct offering of approximately 20.3 million shares of
our common stock with net proceeds of approximately $121.6
million.
- As of March 31, 2017, the
principal balance on our Notes was $18.6 million as compared to
$23.5 million at December 31, 2016.
- We had 224.9 million and 202.7 million
common shares issued and outstanding at March 31, 2017 and
December 31, 2016, respectively, which reflects primarily an
increase in the issuance of shares from the common stock offering
noted above and the first quarter conversions of the Notes.
- Net loss in the first quarter of 2017
was $64.6 million, as compared to a net loss of $59.9 million
incurred in the first quarter of 2016.
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.
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 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.
Contraindications
- Trulance is contraindicated in patients
less than 6 years of age due to the risk of serious
dehydration.
- Trulance is contraindicated in patients
with known or suspected mechanical gastrointestinal
obstruction.
Warnings and Precautions
Risk of Serious Dehydration in Pediatric Patients
- Trulance is contraindicated in patients
less than 6 years of age. The safety and effectiveness of Trulance
in patients less than 18 years of age have not been established. In
young juvenile mice (human age equivalent of approximately 1 month
to less than 2 years), plecanatide increased fluid secretion as a
consequence of stimulation of guanylate cyclase-C (GC-C), resulting
in mortality in some mice within the first 24 hours, apparently due
to dehydration. Due to increased intestinal expression of GC-C,
patients less than 6 years of age may be more likely than older
patients to develop severe diarrhea and its potentially serious
consequences.
- Use of Trulance should be avoided in
patients 6 years to less than 18 years of age. Although there were
no deaths in older juvenile mice, given the deaths in young mice
and the lack of clinical safety and efficacy data in pediatric
patients, use of Trulance should be avoided in patients 6 years to
less than 18 years of age.
Diarrhea
- Diarrhea was the most common adverse
reaction in the two placebo-controlled clinical trials. Severe
diarrhea was reported in 0.6% of patients.
- If severe diarrhea occurs, the health
care provider should suspend dosing and rehydrate the patient.
Adverse Reactions
- In the two combined CIC clinical
trials, the most common adverse reaction in Trulance-treated
patients (incidence ≥2% and greater than in the placebo group) was
diarrhea (5% vs 1% placebo).
Please click here for Full Prescribing
Information.
Forward-Looking Statement
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)
March 31, 2017(unaudited)
December 31, 2016 Assets Cash and cash equivalents $
139,262 $ 82,387 Accounts receivable 6,319 — Inventories 9,647
5,640 Prepaid expenses and other current assets 8,038 889
Total Current assets 163,266 88,916 Other assets 976 936
Total assets $ 164,242 $ 89,852 Liabilities and
Stockholders' Equity Total Current Liabilities $ 43,489 $ 29,430
Senior Convertible Notes, net 16,771 22,665 Derivative financial
instruments – warrants 94 216 Total Liabilities 60,354
52,311 Total Stockholders’ Equity 103,888 37,541 Total
Liabilities and Stockholders' Equity $ 164,242 $ 89,852
Condensed Consolidated Statement of
Operations
($ in thousands except share and per share
data)
(unaudited)
Three MonthsEnded March
31,
Three MonthsEnded March
31,
2017 2016 Net sales $ 98 $ — Cost of goods sold 1,805
— Gross profit (1,707 ) — Costs and Expenses:
Research and development 19,129 21,175 Selling, general and
administrative 41,891 6,375 Loss from Operations
(62,727 ) (27,550 ) Other Expenses: Interest and investment
expense, net (790 ) (7,036 ) Debt conversion expense (1,209 )
(25,615 ) Change in fair value of derivative financial instruments
- warrants 122 260 Total Other Expenses (1,877 )
(32,391 ) Net Loss $ (64,604 ) $ (59,941 ) Net Loss per
Common Share, Basic and Diluted $ (0.30 ) $ (0.51 ) Weighted
Average Common Shares Outstanding 215,484,670 117,626,669
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170510006636/en/
Synergy Pharmaceuticals Inc.Gem Hopkins, 212-584-7610VP,
Investor Relations and Corporate
Communicationsghopkins@synergypharma.com
Synergy Pharmaceuticals, Inc. (NASDAQ:SGYP)
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