Synergy Pharmaceuticals Reports Fourth Quarter and Year-End 2011 Financial
15 Março 2012 - 8:06PM
Synergy Pharmaceuticals, Inc. (Nasdaq:SGYP) (Nasdaq:SGYPU)
(Nasdaq:SGYPW), a developer of new drugs to treat gastrointestinal
disorders and diseases, today reported its financial results for
the fourth quarter and year ended December 31, 2011. Synergy is
developing plecanatide for the treatment of chronic constipation
(CC) and constipation-predominant irritable bowel syndrome (IBS-C).
"2011 was an important year for Synergy. During the year we
raised significant capital and have been delivering on the clinical
development plan for plecanatide, our candidate for the treatment
of chronic constipation and IBS-C," said Gary S. Jacob, Chief
Executive Officer. "2012 will be a transformative year, with
top-line plecanatide data expected by year end and our second GC-C
receptor agonist compound, SP-333, entering the clinic."
2011 and Recent Highlights
- In October 2011, Synergy began the Phase II/III clinical trial
of plecanatide, with top-line data due by year-end 2012.
- In February 2011, Synergy was granted U.S. Patent No.
7,879,802, covering Synergy's novel drug candidate SP-333 to treat
inflammatory bowel disease (IBD).
- During 2011, Synergy raised aggregate gross proceeds of $34.4
million from the sale of its securities.
- On December 1, 2011, Synergy's common stock was listed on The
NASDAQ Capital Market.
Financial Update
Synergy's cash and cash equivalents balance as of December 31,
2011 was $13.2 million, as compared to $1.7 million on December 31,
2010. During the twelve months ended December 31, 2011, net cash
provided by financing activities was $32.6 million net cash used in
operating activities was $21.2 million, including approximately
$13.4 million in Research & Development expenses. Net loss for
the twelve months ended December 31, 2011 was $14.5 million or
$0.30 per share, as compared to a net loss of $15.2 million, or
$0.34 per share, for the twelve months ended December 31,
2010. In 2011, Synergy reported a gain of $5.3 million
resulting from changes in fair value of derivative instruments
(warrants), whereas such gains in 2010 were $0.3 million.
Net loss for the quarter ended December 31, 2011 was $5.6
million, or $0.12 per share, as compared to a net loss of $3.7
million, or $0.08 per share, for the quarter ended December 31,
2010. In 2011, Synergy reported a gain of $1.9 million
resulting from changes in fair value of derivative instruments
(warrants), whereas such gains in 2010 were $0.2 million.
Synergy had approximately 54.3 million common shares outstanding
at March 15, 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 hormone
uroguanylin, and functions by activating the guanylate cyclase C
receptor on epithelial cells of the GI tract. The company completed
a Phase I study of plecanatide in healthy volunteers and a Phase
IIa clinical trial in CIC patients. In October, 2011, Synergy
initiated dosing of patients in a major Phase II/III clinical trial
of plecanatide to treat chronic idiopathic constipation.
Plecanatide is also being developed to treat
constipation-predominant irritable bowel syndrome, with the first
trial in IBS-C patients planned for 2012. Synergy's second GC-C
agonist SP-333 is currently in pre-clinical development to treat
inflammatory bowel diseases. More information is available at
http://www.synergypharma.com.
Disclosure Notice
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," "believe," "forecast,"
"estimated" 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.
Synergy does not undertake an obligation to update or revise any
forward-looking statement. Investors should read the risk factors
set forth in Synergy's Annual Report on Form 10-K for the year
ended December 31, 2011 filed with the Securities and Exchange
Commission on March 15, 2012.
|
Condensed Consolidated
Balance Sheets (in thousands) |
(unaudited) |
|
|
|
December 31, 2011 |
December
31, 2010 |
Assets |
|
|
Cash, cash equivalents |
$13,245 |
$1,707 |
Prepaid expenses and other current
assets |
1,063 |
998 |
Total current assets |
14,308 |
2,705 |
Property and equipment, net |
6 |
8 |
Other assets |
1,556 |
1,688 |
Total assets |
$15,869 |
$4,401 |
|
|
|
Liabilities and Stockholders'
Equity |
|
|
Accounts payable |
$1,416 |
$2,961 |
Accrued expenses |
1,331 |
2,051 |
Total current liabilities |
2,747 |
5,012 |
Derivative financial instruments
-warrants |
3,325 |
3,488 |
Total Liabilities |
6,072 |
8,500 |
Total stockholders' equity |
9,797 |
(4,099) |
Total liabilities and stockholders'
equity |
$15,869 |
$4,401 |
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Statement of
Operations |
|
|
|
|
|
(in thousands except for weighted average
shares) (unaudited) |
Quarter ended December
31, 2011 |
Quarter ended December
31, 2010 |
Year ended December 31,
2011 |
Year ended December 31,
2010 |
|
|
|
|
|
|
|
Revenues |
$ -- |
$ -- |
$ -- |
$ -- |
|
Costs and Expenses: |
|
|
|
|
|
Research and development |
5,703 |
1,686 |
13,419 |
9,559 |
|
General and administrative |
2,222 |
2,724 |
6,746 |
6,562 |
|
|
|
|
|
|
|
Loss from Operations |
(7,925) |
(4,410) |
(20,165) |
(16,121) |
|
Other income |
362 |
494 |
363 |
494 |
|
Interest and investment income |
26 |
25 |
90 |
108 |
|
Interest expense |
-- |
-- |
(12) |
-- |
|
Change in Fair Value of Financial
Instruments |
1,911 |
185 |
5,257 |
297 |
|
|
|
|
|
|
Net Loss |
$(5,626) |
$(3,706) |
$(14,467) |
$(15,222) |
|
|
|
|
|
Net Loss per common share, basic and
diluted |
$(0.12) |
$(0.08) |
$(0.30) |
$(0.34) |
Weighted Average Common Shares Outstanding
(a) |
48,657,013 |
45,986,047 |
47,598,240 |
44,875,356 |
(a) Weighted average shares
outstanding reflects retroactive change of a one for two (1:2)
reverse stock split effective on November 30, 2011 |
CONTACT: Investor Contact Information:
Danielle Spangler
The Trout Groupsynergy@troutgroup.com
(646) 378-2924
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