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
- On January 19, 2017, the United
States (U.S.) Food and Drug Administration (FDA) approved our first
product, plecanatide, under the trademarked name TRULANCE, for the
treatment of adults with chronic idiopathic constipation (CIC). The
efficacy and safety of TRULANCE was evaluated in the largest Phase
3 CIC clinical trials to date, which included more than 2,600
patients in two randomized, 12-week, double-blind,
placebo-controlled studies of TRULANCE. In an integrated analysis
of both studies, diarrhea was the most common adverse reaction,
reported in 5% of patients treated with TRULANCE compared to 1% of
patients treated with placebo. The recommended adult dosage of
TRULANCE is 3 mg taken orally, once daily, with or without food.
TRULANCE will be available in the U.S. this quarter.
TRULANCE IBS-C Development
Update
- In December 2016, we announced positive
top-line results in the two Phase 3 clinical trials of TRULANCE for
the treatment of adults with IBS-C. In both trials, TRULANCE met
the study’s primary endpoint showing statistical significance in
the percentage of patients who were overall responders compared to
placebo during the 12-week treatment period. An Overall Responder,
as defined by the FDA, is a patient who fulfills both ≥ 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. This is the
current primary endpoint required for FDA approval in IBS-C. In
both studies, the most common adverse event was diarrhea (Study 1 =
3.2% at 3 mg and 3.7% at 6 mg compared to 1.3% at placebo; Study 2
= 5.4% at 3 mg and 4.3% at 6 mg compared to 0.6% at placebo). We
plan to file a new drug application supplement with clinical data
(sNDA) in the first quarter of 2017 and expect a 10-month review
period from submission. We plan to present additional Phase 3 data
from the two IBS-C trials at an appropriate scientific meeting
later this year.
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
Product Readiness
- Established a robust supply chain
process and quality management system.
- Implemented our third party logistics
(3PL) distribution network.
- Trade and sample stock manufactured and
on-track for launch this quarter.
- Launching TRULANCE 3 mg in an
innovative 30-count blister pack.
Market and Brand Readiness
- We are very encouraged by the feedback
we have received from our market research, advisory boards and
field-based customer meetings.
- Completed extensive market research
with more than 2,700 healthcare providers and over 5,300
patients.
- Conducted multiple advisory boards with
national and regional GI key opinion leaders, other healthcare
providers and payers.
- Since January 2016, our market access
team has been meeting with key payer customers that represent over
230 million covered lives in the U.S.
- Initiated pre-launch multimedia and
digital campaigns to drive company awareness and disease education,
focusing on current unmet needs of patients with CIC.
- Finalized TRULANCE core marketing
strategies and launch tactics, including a compliant,
value-optimizing, cost effective promotional mix to reach the
broadest universe of prescribers.
- Co-pay card programs and other patient
assistance programs in place which will help us achieve access in
2017.
- Finalized pricing strategy for TRULANCE
and will launch with a wholesale acquisition cost (WAC) of
$353.48.
Organizational Readiness
- Utilizing a hybrid sales model to reach
key prescribers and influencers at launch.
- Less than 20% of prescribers in the
U.S. currently account for over 70% of the branded constipation
prescription market. These prescribers, which include
gastroenterologists and primary care physicians, will be the focus
of our field force at launch.
- Hired Synergy Regional Business
Directors averaging 11 years of management experience and over 10
years in relevant GI fields.
- Hired Synergy Regional GI Account
Specialists averaging 13 years of pharmaceutical experience and 8.5
years of GI experience.
- Partnered with Publicis Touchpoint
Solutions, Inc. who have hired highly experienced sales
representatives that will be fully dedicated to TRULANCE at launch.
- Our Publicis Touchpoint sales
representatives have an average of 11.5 years of pharmaceutical
experience, and nearly 6 years of GI experience, with over 90%
coming from other peer GI and PCP companies.
- Medical education efforts have been
ongoing since March 2016.
Financial Results
- As of December 31, 2016, we had
approximately $82.4 million of cash and cash equivalents on hand as
compared to approximately $111.8 million cash and cash equivalents
and available for sale securities as of December 31,
2015.
- Net cash used in operating activities
was $129.8 million in the year ended December 31, 2016, as compared
to $101 million in the year ended December 31, 2015.
- Research and development expenses in
the fourth quarter of 2016 were approximately $17.2 million, as
compared to $19.9 million in the fourth quarter of 2015. These
decreased expenses were primarily a result of completion of IBS-C
studies.
- Selling, general and administrative
expenses were approximately $25.2 million in the fourth quarter of
2016, as compared to approximately $7.1 million in the fourth
quarter of 2015. These increased expenses primarily reflect
commercial preparedness and planning expenses to support an
anticipated launch of Trulance during the first quarter of
2017.
- On January 31, 2017, Synergy
entered into an underwriting agreement to issue and sell 20,325,204
shares of common stock of the Company in an underwritten public
offering. The Offering closed on February 6, 2017, yielding net
proceeds of approximately $121.6 million, after deducting
underwriting discounts and commissions and estimated offering
expenses payable by the Company.
- As of December 31, 2016, the
principal balance on our 7.50% Convertible Senior Notes (“Notes”)
due 2019 was $23.5 million as compared to $159 million at
December 31, 2015.
- We had 202.7 million and 113.7 million
common shares issued and outstanding at December 31, 2016 and
December 31, 2015, respectively, which reflects primarily an
increase in the issuance of shares from the conversions of Notes,
equity offering in May 2016 and exercise of warrants.
- Net loss in the fourth quarter of 2016
was $59.9 million, as compared to a net loss of $30.4 million
incurred in the fourth quarter of 2015.
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.
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 Assets
Cash, 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 $ 19,579
Senior 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 $
115,929
Synergy 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
Synergy Pharmaceuticals, Inc. (NASDAQ:SGYP)
Historical Stock Chart
From Aug 2024 to Sep 2024
Synergy Pharmaceuticals, Inc. (NASDAQ:SGYP)
Historical Stock Chart
From Sep 2023 to Sep 2024