Synergy Pharmaceuticals Reports Third Quarter 2013 Financial Results

  Synergy Pharmaceuticals Reports Third Quarter 2013 Financial Results

Business Wire

NEW YORK -- November 12, 2013

Synergy Pharmaceuticals Inc. (Nasdaq: SGYP), a developer of new drugs to treat
gastrointestinal disorders and diseases, today reported its financial results
and business update for the third quarter ended September 30, 2013.

Recent Developments

  *On August 5, 2013, Synergy announced the results of its End-of-Phase 2
    meeting with the U.S. Food and Drug Administration (FDA) covering its lead
    guanylate cyclase-C (GC-C) agonist, plecanatide, for the treatment of
    chronic idiopathic constipation (CIC). At that meeting, agreement was
    reached with the FDA on design, duration, size and primary and secondary
    endpoints for the plecanatide pivotal phase 3 program, confirming safety
    and efficacy in CIC patients. Synergy plans to initiate the first phase 3
    trial in the fourth quarter of 2013.
  *On August8, 2013, Synergy’s subsidiary, ContraVir Pharmaceuticals,Inc.
    filed a Form10 registration statement with the U.S. Securities and
    Exchange Commission, for a planned spin-off of ContraVir to the Synergy
    common stock holders. ContraVir holds the rights to FV-100 , a drug being
    developed to treat shingles.

  *On October 31, 2013, Synergy initiated a phase 2 study of SP-333, its
    second-generation GC-C agonist and once daily oral drug, in patients with
    Opioid-Induced Constipation.

Financial Update

Synergy's cash, cash equivalents and available-for-sale securities balance as
of  September 30, 2013 was  $82.1 million, as compared to $32.5 million on
December 31, 2012. During the nine months ended September 30, 2013, net cash
provided by financing activities was $89.2 million resulting from its
controlled equity sales of its common stock and underwritten public offering,
as compared to $48.2 million during the nine months ended September 30, 2012.
Net cash used in operating activities during the nine months ended September
30, 2013 and 2012 was $38.7 million and $23.1 million, respectively. Net loss
for the nine months ended September 30, 2013 was $42.3 million or $0.51 per
share, as compared to a net loss of $27.5 million, or $0.46 per share, for the
nine months ended September 30, 2012.

Net loss for the quarter ended September 30, 2013 was $13.5 million or $0.15
per share, as compared to a net loss of $9.9 million, or $0.15 per share, for
the quarter ended September 30, 2012. During the quarter ended September 30,
2013, non-cash expense items, principally the change in fair value of
derivative instruments and stock based compensation expense, totaled $1
million, or $0.01 per share, whereas such items in the three months ended
September 30, 2012 totaled $0.4 million, or $0.01 per share.

Synergy had approximately 90 million common shares issued and outstanding at
September 30, 2013.

About Synergy Pharmaceuticals Inc.

Synergy Pharmaceuticals is a biopharmaceutical company focused on the
development of new drugs to treat patients with gastrointestinal (GI) diseases
and disorders. Synergy is developing proprietary analogs of uroguanylin, a
naturally occurring GI hormone and physiological agonist of the human GC-C
receptor. Synergy’s lead GC-C agonist, plecanatide, and second-generation GC-C
agonist, SP-333, mimic uroguanylin’s natural functions by activating GC-C
receptors in the GI tract, promoting intestinal fluid secretion and other
digestive responses.

Plecanatide has been validated in a phase 2b study evaluating safety and
efficacy in CIC patients and Synergy plans to initiate the pivotal phase 3 CIC
program in the fourth quarter of 2013. Synergy is also developing plecanatide
for irritable bowel syndrome with constipation (IBS-C) and plans to announce
topline data from its ongoing phase 2b IBS-C trial in the first quarter of
2014.

Synergy’s second GC-C agonist, SP-333, is in clinical development to treat
opioid-induced constipation (OIC) and ulcerative colitis (UC). SP-333 has
successfully completed phase 1 single and multiple ascending dose studies in
healthy volunteers and is currently in a phase 2 clinical trial for OIC. More
information is available at 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 Form 10-K for the year
ended December 31, 2012 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.


Condensed Consolidated Balance Sheets ($ in thousands)
                                                         
                                      September 30, 2013     December 31, 2012
                                      (unaudited)
Assets
Cash, cash equivalents and short
term available                        $      82,105          $      32,502
for sale securities
Prepaid expenses and other current          5,244                 1,547
assets
Total Current Assets                         87,349                 34,049
Other Assets                                711                   3,356
Total Assets                          $      88,060          $      37,405
Liabilities and Stockholders'
Equity
Accounts payable                             10,275                 5,255
Accrued expenses                            2,892                 2,060
Total Current Liabilities                    13,167                 7,315
Derivative financial instruments            1,050                 5,258
-warrants
Total Liabilities                            14,217                 12,573
Total Stockholders' Equity                  73,843                24,832
Total Liabilities and Stockholders'   $      88,060          $      37,405
Equity

Condensed Consolidated
Statement of Operations
($ in thousands
except share                        Three Months   Nine Months    Nine Months
and                 Three Months    ended          ended          ended
per share data)   ended          September     September     September
                    September 30,   30,            30,            30,
                   2013            2012           2013           2012

(unaudited)
                                                                  
Revenues            $  --           $ --           $ --           $ --
Costs and
Expenses:
Research and           10,782         8,246          34,181         21,210
development
General and           2,692         1,843         8,773         5,493
administrative
Loss from              (13,474)       (10,089)       (42,954)       (26,703)
Operations
Other income           --             --             --             256
Interest and
investment             14             63             48             150
income
Change in fair
value of
derivative            (77)          140           633           (1,169)
instruments -
warrants
                                                                  
Net Loss            $  (13,537)     $ (9,886)      $ (42,273)     $ (27,466)
                                                                  
Net Loss per
common share,       $  (0.15)       $ (0.15)       $ (0.51)       $ (0.46)
basic and
diluted
Weighted
Average Common        90,182,115    65,806,178    83,548,398    60,194,004
Shares
Outstanding

Contact:

Synergy Pharmaceuticals
Media
Gem Gokmen
Office: 212-584-7610
Mobile: 646-637-3208
ggokmen@synergypharma.com
or
Investor
Bernard Denoyer
Office: 212-297-0020
Mobile: 203-300-8147
bdenoyer@synergypharma.com
 
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