Synergy Pharmaceuticals Reports 2012 Fourth Quarter and Full-Year Financial Results

Synergy Pharmaceuticals Reports 2012 Fourth Quarter and Full-Year Financial
Results

NEW YORK, March 18, 2013 (GLOBE NEWSWIRE) -- 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
fourth quarter and year ended December 31, 2012. Synergy is developing
plecanatide for the treatment of chronic idiopathic constipation (CIC) and
constipation-predominant irritable bowel syndrome (IBS-C).

Recent Developments

  * Plecanatide demonstrated tolerability and met the primary and key
    secondary endpoints in a large multicenter study of CIC patients. Full
    study results will be announced in a late-breaking oral presentation at
    Digestive Disease Week 2013.
  * Commencement of a Phase IIb clinical trial of plecanatide to treat
    patients with IBS-C.
  * Completion of a Phase I single-ascending-dose clinical trial of SP-333, a
    second guanylate cyclase C (GC-C) agonist designed to treat inflammatory
    bowel disease (IBD) including ulcerative colitis (UC).
  * Initiation of a Phase I multiple-ascending-dose clinical trial of SP-333
    in healthy volunteers.
  * The company successfully completed its acquisition of Callisto
    Pharmaceuticals, Inc.

Financial Update

Synergy's cash, cash equivalents and short term available for sale securities
balance as of December 31, 2012 was $32.5 million, as compared to $13.2
million on December 31, 2011. During the year ended December 31, 2012 and 2011
net cash provided by financing activities were $52.1 million and $32.6
million, respectively. Net cash used in operating activities during the year
ended December 31, 2012 and 2011 was $31.1 million and $21.2 million,
respectively. Net loss for the year ended December 31, 2012 was $39.4 million
or $0.64 per share, as compared to a net loss of $14.5 million, or $0.30 per
share, for the year ended December 31, 2011.

Net loss for the quarter ended December 31, 2012 was $12.0 million, or $0.18
per share, as compared to a net loss of $5.6 million, or $0.12 per share, for
the quarter ended December 31, 2011.

Synergy had approximately 67 million common shares outstanding at December 31,
2012.

About Synergy Pharmaceuticals Inc.

Synergy is a biopharmaceutical company focused on the development of new drugs
to treat gastrointestinal disorders and diseases. Synergy's lead proprietary
drug candidate plecanatide is a synthetic analog of the human gastrointestinal
(GI) hormone uroguanylin, and functions by activating the guanylate cyclase C
receptor on epithelial cells of the GI tract. Synergy previously completed a
Phase I study of plecanatide in healthy volunteers, a Phase IIa clinical trial
in CIC patients. On January 2, 2013, Synergy announced positive results in a
large multicenter clinical trial of plecanatide to treat CIC. Plecanatide is
also being developed to treat patients with IBS-C. Synergy's second GC-C
agonist SP-333 is in clinical development to treat inflammatory bowel
diseases, and is presently in a Phase I trial in healthy volunteers. More
information is available at http://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)
                                                              
(unaudited)                                December 31, 2012 December 31, 2011
Assets                                                        
Cash, cash equivalents and short term      $32,502           $13,245
available for sale securities
Prepaid expenses and other current assets  1,547             1,063
Total current assets                       34,049            14,308
Other assets                               3,356             1,562
                                                              
Total assets                               $37,405           $15,870
                                                              
Liabilities and Stockholders' Equity                          
Accounts payable                           5,255             $1,416
Accrued expenses                           2,060             1,331
Total current liabilities                  7,315             2,747
Derivative financial instruments -warrants 5,258             3,325
Total Liabilities                          12,573            6,072
Total stockholders' equity                 24,832            9,798
                                                              
Total liabilities and stockholders' equity $37,405           $15,870

                                                                   
Condensed Consolidated                                             
Statement of Operations
($ in thousands except     Three Months Three Months Year ended   Year Ended
shares, and per share      ended        ended        December 31, December 31,
data)                      December 31, December 31, 2012         2011
                           2012         2011
                                                                   
Revenues                   $  --        $  --        $  --        $  --
Costs and Expenses:                                                
Research and development   9,085        5,703        29,294       13,419
Purchased in-process       --           --           1,000        --
research and development
General and administrative 2,447        2,222        7,941        6,745
Loss from Operations       (11,532)     (7,925)      (38,235)     (20,164)
Other income               250          362          506          362
Interest and investment    68           26           218          90
income
Interest expense           --           --           --           (12)
Change in Fair Value of    (764)        1,911        (1,933)      5,257
Financial Instruments
                                                                   
Net Loss                   $(11,978)    $(5,626)     $(39,444)    $(14,467)
                                                                   
Net Loss per common share, $ (0.18)     $ (0.12)     $ (0.64)     $ (0.30)
basic and diluted
Weighted Average Common    66,194,306   48,657,013   61,702,277   47,598,240
Shares Outstanding (a)

CONTACT: Investor Contact Information:
         Danielle Spangler
         The Trout Group
         synergy@troutgroup.com
         (646) 378-2924