DGAP-News: Synergy Pharmaceuticals Reports 2012 Fourth Quarter and Full-Year Financial Results
(firmenpresse) - Synergy Pharmaceuticals
18.03.2013 22:00
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NEW YORK, 2013-03-18 22:00 CET (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 LitigationReform 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, December 31,
2012 2011
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Assets
Cash, cash equivalents and short term available $32,502 $13,245
for sale securities
Prepaid expenses and other current assets 1,547 1,063
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Total current assets 34,049 14,308
Other assets 3,356 1,562
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Total assets $37,405 $15,870
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Liabilities and Stockholders' Equity
Accounts payable 5,255 $1,416
Accrued expenses 2,060 1,331
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Total current liabilities 7,315 2,747
Derivative financial instruments -warrants 5,258 3,325
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Total Liabilities12,573 6,072
Total stockholders' equity 24,832 9,798
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Total liabilities and stockholders' equity $37,405 $15,870
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Condensed Consolidated
Statement of Operations
($ in thousands except Three Three Year ended Year Ended
shares, and per share data) Months Months December December
ended ended 31, 2012 31, 2011
December December
31, 2012 31, 2011
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Revenues $ -- $ -- $ -- $ --
Costs and Expenses:
Research and development 9,085 5,703 29,294 13,419
Purchased in-process research -- -- 1,000 --
and development
General and administrative 2,447 2,222 7,941 6,745
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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
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Net Loss $(11,978) $(5,626) $(39,444) $(14,467)
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Net Loss per common share, $ (0.18) $ (0.12) $ (0.64) $ (0.30)
basic and diluted
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Weighted Average Common 66,194,306 48,657,013 61,702,277 47,598,240
Shares Outstanding (a)
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CONTACT: Investor Contact Information:
Danielle Spangler
The Trout Group
synergy(at)troutgroup.com
(646) 378-2924
News Source: NASDAQ OMX
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Language: English
Company: Synergy Pharmaceuticals
United States
Phone:
Fax:
E-mail:
Internet:
ISIN: US8716393082
WKN:
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