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,
2016.
“Our exciting transformation from a purely research and
development company into a fully integrated commercial organization
continues unabated as we successfully advance and execute against
our key strategic priorities,” said Gary S. Jacob, Chairman and
Chief Executive Officer of Synergy Pharmaceuticals Inc. “These
priorities are guided by our overarching mission to optimize the
value of plecanatide and maximize shareholder value.”
“The rest of 2016 promises to be an exciting time as we expect
top-line results in our two phase 3 IBS-C trials with
plecanatide. We are especially pleased with our ongoing
dialogue with the FDA, including the results of our recent
mid-cycle review meeting. Building the right commercial strategy
and having the ability to successfully execute on the launch plan
requires a strong team and we are fortunate to be attracting
talented leaders with relevant experience from across our industry.
I am very proud of the Synergy organization which is committed to a
successful launch of plecanatide and bringing this important new
treatment option to patients suffering from CIC and IBS-C,” added
Dr. Jacob.
Second Quarter 2016 and Recent Highlights
Research & Development
Plecanatide CIC Development Update
- The Food and Drug Administration (FDA)
has completed its mid-cycle review meeting of the plecanatide new
drug application (NDA) in chronic idiopathic constipation (CIC). To
date, no significant issues have been identified. Additionally, the
FDA informed us that at this time there are no plans for an
advisory committee meeting in connection with its review of the
plecanatide NDA in CIC. The plecanatide NDA in CIC is supported by
two double-blind placebo-controlled phase 3 trials and one
open-label long term safety study. Over 3,500 patients were exposed
to plecanatide in the CIC clinical development program. The
Prescription Drug User Fee Act (PDUFA) target action date is
January 29, 2017.
- In May 2016, we presented additional
plecanatide data, including one oral presentation and five posters,
at Digestive Disease Week (DDW) 2016. Data presented at DDW showed
that plecanatide met the primary and secondary endpoints in two
phase 3 CIC clinical trials. In both trials, plecanatide
significantly improved durable overall complete spontaneous bowel
movement (CSBM) responder rates relative to placebo (primary
endpoint). Plecanatide-treated patients also showed immediate and
sustained improvements that were statistically significant in CSBM
and SBM frequency and stool consistency scores compared to placebo.
Furthermore, plecanatide showed statistically significant
improvement in abdominal symptoms, such as straining and bloating,
as well as constipation severity and treatment satisfaction scores
compared to placebo. Most adverse events were mild to moderate in
severity; the most common adverse event was diarrhea (<6.0%
diarrhea rates in both trials). In addition to the plecanatide CIC
clinical data, we presented new in vitro data showing that the
pH-dependent activity of plecanatide replicates that of the body's
naturally occurring GI peptide, uroguanylin.
Plecanatide IBS-C Development Update
- We have completed over 95% of planned
patient enrollment in our two phase 3 irritable bowel syndrome with
constipation (IBS-C) clinical trials with plecanatide and we expect
top-line data in both trials in the fourth quarter of this year.
The two double-blind placebo-controlled trials are designed to
enroll a total of approximately 2,100 IBS-C patients. The primary
endpoint being evaluated in these trials is the percentage of
patients who are Overall Responders during the 12-week treatment
period. An Overall Responder, as defined by the FDA, is a patient
who is a weekly responder (i.e. meets both a 30% abdominal pain
intensity reduction and stool frequency increase criteria in the
same week) for at least 6 of the 12 treatment weeks. Plecanatide
previously met this endpoint in a phase 2b trial with 424 IBS-C
patients that was completed in 2014.
Dolcanatide UC Development Update
- Earlier this year, we announced
positive proof-of-concept in a phase 1b double-blind
placebo-controlled four-week trial evaluating dolcanatide treatment
in 28 patients with mild-to-moderate ulcerative colitis. We intend
to announce next steps for the dolcanatide phase 2 clinical program
in patients with mild-to-moderate ulcerative colitis following
agreement on the development plans with regulators.
Commercial Planning & Launch Preparation
Our commercial, medical affairs and technical operations teams
are continuing to execute on our key strategic imperatives to
ensure launch readiness, including the following major
initiatives:
Product Readiness
- Ensuring a robust supply chain process
for launch and throughout plecanatide's life-cycle
- Building sufficient trade and sample
stock for launch in early 2017
- Implementing our 3PL distribution
network
- Developing and implementing strong
Quality Management Systems
Market/Brand Readiness
- Driving and raising awareness of
Synergy Pharmaceuticals, the unmet medical needs, and burden of
disease
- Initiating KOL engagement &
speakers bureau preparation plans
- Defining our pricing and reimbursement
strategy, as well as initiating field payer activities
- Developing the plecanatide branding,
positioning, messaging and creative launch campaign based on
customer insights & segmentation
Organizational Readiness
- Hiring and onboarding key talent to
support critical functions
- Onboarding and fielding our Market
Access and Medical Liaison Teams
- Ensuring our IT and Compliance systems
needs are defined and implemented
- Continuing to evaluate all potential
sales force options, including a hybrid infrastructure supplemented
by a contract sales organization and/or co-promotion partner
Financial Results
- As of June 30, 2016, we had
approximately $141.2 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 $60.1 million in the six months ended June 30, 2016, as
compared to $49 million in the six months ended June 30, 2015.
- Research and development expenses in
the second quarter of 2016 were approximately $26.6 million, as
compared to $19.5 million in the second quarter of 2015. These
increased expenses were primarily a result of higher spending on
IBS-C studies, the filing of our CIC NDA in January 2016, and
plecanatide API contract manufacturing costs for validation batches
prepared for our anticipated commercial launch next year.
- Selling, general and administrative
expenses were approximately $10.2 million in the second quarter of
2016, as compared to approximately $7.4 million in the second
quarter of 2015. These increased expenses were primarily a result
of higher spending in preparation for our anticipated commercial
launch next year.
- On May 6, 2016, we closed on a
registered direct offering of approximately 30 million shares of
our common stock with gross proceeds of approximately $89.8
million.
- As of June 30, 2016, the principal
balance of our 7.50% Convertible Senior Notes (“Notes”) due 2019
was $79.2 million as compared to $159.0 million at
December 31, 2015.
- We had 179.8 million and 113.7 million
common shares issued and outstanding at June 30, 2016 and
December 31, 2015, respectively, which reflects primarily an
increase in the issuance of shares from the first quarter
conversions of the Notes and the common stock offering noted
above.
- Net loss in the second quarter of 2016
was $38.6 million, as compared to a net loss of $33.7 million
incurred in the second quarter of 2015.
About Synergy Pharmaceuticals Inc.
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 on analogs of uroguanylin, a naturally
occurring human GI peptide, for the treatment of functional GI
disorders and inflammatory bowel disease. Synergy is developing and
retains 100% worldwide rights to its proprietary uroguanylin analog
technology platform that includes two lead product candidates -
plecanatide and dolcanatide. Plecanatide is Synergy's first
uroguanylin analog currently being evaluated for use as a
once-daily tablet for the treatment of CIC and IBS-C. Dolcanatide
is Synergy's second uroguanylin analog currently being explored for
ulcerative colitis. 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, 2015 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 ($ in thousands)
June 30,
2016(unaudited) December 31, 2015 Assets
Cash, cash equivalents and available for sale securities $ 141,219
$ 111,750 Prepaid expenses and other current assets 4,266
3,305 Total Current assets 145,485 115,055 Other assets
1,067 874 Total assets $ 146,552 $ 115,929
Liabilities and Stockholders' Equity/(Deficit) Total
Current Liabilities $ 23,127 $ 19,579 Senior Convertible Notes, net
75,818 151,241 Derivative financial instruments – warrants 85
322 Total Liabilities 99,030 171,142 Total
Stockholders’ Equity/(Deficit) 47,522 (55,213 ) Total
Liabilities and Stockholders' Equity/(Deficit) $ 146,552 $
115,929
Condensed Consolidated Statement of
Operations
($ in thousands except share and per share
data)
(unaudited)
Three Months Ended
June 30,
Three Months Ended
June 30,
Six Months Ended
June 30,
Six Months Ended
June 30,
2016 2015 2016 2015 Revenues $ — $ — $
— $ — Costs and Expenses: Research and development 26,611 19,525
47,786 37,723 Selling, general and administrative 10,249
7,394 16,624 12,000 Loss from Operations
(36,860 ) (26,919 ) (64,410 ) (49,723 ) Other Loss: Interest and
investment expense, net (1,673 ) (5,207 ) (8,709 ) (9,524 ) Debt
conversion expense — — (25,615 ) — Change in fair value of
financial instruments (23 ) (1,542 ) 237 (1,810 ) Total
Other Loss (1,696 ) (6,749 ) (34,087 ) (11,334 )
Net Loss $ (38,556 ) $ (33,668 ) $ (98,497 ) $
(61,057 ) Net Loss per Common Share, Basic and Diluted $
(0.23 ) $ (0.34 ) $ (0.69 ) $ (0.62 ) Weighted Average
Common Shares Outstanding 168,127,144 100,343,637
143,017,970 98,523,696
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version on businesswire.com: http://www.businesswire.com/news/home/20160808006264/en/
Company:Synergy Pharmaceuticals Inc.Gem Hopkins,
212-584-7610VP, Investor Relations and Corporate
Communicationsghopkins@synergypharma.com
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