Synergy Pharmaceuticals Reports First Quarter 2013 Financial Results

Synergy Pharmaceuticals Reports First Quarter 2013 Financial Results

NEW YORK, May 9, 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
first quarter ended March 31, 2013. Synergy is developing plecanatide for the
treatment of chronic idiopathic constipation (CIC) and
constipation-predominant irritable bowel syndrome (IBS-C).

Recent Developments

  *On January 2, 2013, Synergy announced positive results from its large
    multicenter clinical trial of its lead investigational drug plecanatide in
    patients with CIC.
    
  *On January17, 2013, Synergy completed its merger with Callisto
    Pharmaceuticals, Inc.
    
  *On March15, 2013, Synergy announced that the full study results from its
    large multicenter CIC clinical trial would be featured in a late-breaking
    oral presentation session at Digestive Disease Week 2013 in Orlando,
    Florida on Tuesday, May21, 2013.
    
  *On April 16, 2013, Synergy closed a public offering of 16,375,000 shares
    of its common stock at a price of $5.50 per share, less underwriting
    discounts and commissions. The net proceeds to Synergy from this sale was
    approximately $84.4 million, after deducting underwriting discounts and
    commissions and other estimated offering expenses payable by
    Synergy.(Pro-forma Balance Sheets below)

Financial Update

Synergy's cash, cash equivalents and short term available for sale securities
balance as of March 31, 2013 was $21.1 million, as compared to $32.5 million
on December 31, 2012. During the three months ended March 31, 2013 net cash
provided by financing activities was $4.6 million from the controlled equity
sales of its common stock, whereas there was no such financing activity during
the three months ended March 31, 2012. Net cash used in operating activities
during the three months ended March 31, 2013 and 2012 was $15.6 million and
$6.8 million, respectively.

Net loss for the three months ended March 31, 2013 was $18.7 million or $0.26
per share, as compared to a net loss of $7.0 million, or $0.13 per share, for
the three months ended March 31, 2012. During the three months ended March 31,
2012 non-cash expense items, principally the change in fair value of
derivative instruments and share based compensation expense, totaled $2.4
million, or $0.03 per share, whereas such items in the three months ended
March 31, 2012 totaled $.4 million, or $0.01 per share.

Synergy had approximately 73.8 million common shares outstanding at March 31,
2013.

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 and a Phase IIa clinical
trial in CIC patients. On January 2, 2013, Synergy announced positive results
in a Phase II/III 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)
                                                           
                                             March 31, 2013 December 31, 2012
                                             (unaudited)    
Assets                                                      
Cash, cash equivalents and short term         $21,116        $32,502
available for sale securities
Prepaid expenses and other current assets     1,573          1,547
Total Current Assets                          22,689         34,049
Other Assets                                  201            3,356
                                                           
Total Assets                                  $22,890        $37,405
Liabilities and Stockholders' Equity                        
Accounts payable                              5,978          5,255
Accrued expenses                              3,312          2,060
Total Current Liabilities                     9,290          7,315
Derivative financial instruments – warrants   6,351          5,258
Total Liabilities                             15,641         12,573
Total Stockholders' Equity                    7,249          24,832
                                                           
Total Liabilities and Stockholders' Equity    $22,890        $37,405


Condensed Consolidated Statement of Operations
($ in thousands except share and per share data)
(unaudited)                                                
                                        Three Months ended Three Months ended
                                        March 31, 2013     March 31, 2012
                                                          
                                                          
Revenues                                 $ --               $ --
Costs and Expenses:                                        
Research and development                 14,344             5,338
General and administrative               3,278              1,732
Loss from Operations                     (17,622)           (7,070)
Interest and investment income           18                 39
Change in Fair Value of Financial        (1,093)            8
Instruments
                                                          
Net Loss                                 $(18,697)          $(7,023)
                                                          
Net Loss per common share, basic and     $(0.26)            $(0.13)
diluted
Weighted Average Common Shares           72,789,006         54,298,079
Outstanding

Pro-forma Balance Sheets

The following table sets forth the pro-forma effect on the financial position
of the Company had the April 16, 2013 public offering discussed above taken
place as of March 31, 2013:

                                              Effect of       
                                March 31, 2013 April 16, 2013  March 31, 2013
($000's except share amounts)    As Reported    Public Offering Pro-forma
                                                             
                                                             
Cash, cash equivalents and       $21,116        $84,444         $105,560
available for sale securities
Total Assets                     22,890         84,444          107,334
                                                             
Common Stock                     8              2               10
Additional paid-in-capital       134,991        84,442          219,433
(Deficit) accumulated during     (127,750)      --              (127,750)
development stage
Total stockholder's equity       7,249          84,444          91,693
                                                             
Total liabilities and            $22,890        $84,444         $107,334
stockholder's equity
                                                             
Common Shares Outstanding        73,779,680     16,375,000      90,154,680

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