CAMBRIDGE, Mass., Mar 07, 2012 (BUSINESS WIRE) –
Zalicus Inc.
/quotes/zigman/120688/quotes/nls/zlcs ZLCS
+6.93%
today reported financial results for the
fourth quarter and year ended December 31, 2011.
“In 2011, we made significant progress in advancing our product
candidates in clinical development, including Synavive, Z160 and Z944,”
commented Mark H.N. Corrigan, MD, President and CEO of Zalicus. “During
2012, we will see the results of those studies and make important
decisions on next steps. This is evident with the successful
reformulation of Z160, in which we have achieved the consistent exposure
levels necessary to evaluate its efficacy in a Phase 2 clinical study
for neuropathic pain later this year.”
Fourth Quarter 2011 and Recent Accomplishments:
Ion Channel Programs:
Significant progress has been made with our Ion channel programs this
quarter.
–
Initiated and successfully completed a Phase 1 clinical trial
evaluating the pharmacokinetics and safety of a new formulation of
Z160, a novel oral N-type calcium channel blocker. Z160 has been
successfully reformulated to achieve substantial bioavailability and
solubility improvements using a novel, proprietary formulation
technology. Based on the data from this study, Zalicus plans to
advance Z160 into Phase 2 clinical development for neuropathic pain in
the second half of 2012.
–
Initiated a Phase 1 clinical trial evaluating the pharmacokinetics and
safety of Z944, a novel oral T-type calcium channel blocker with
demonstrated preclinical potential for the treatment of acute and
inflammatory pain.
–
Published preclinical data in the journal Science Translational
Medicine, describing the activity of Z944 to potently suppress
seizures. This data reinforces the potential biologic activity of
Z944, as it is generally understood that conditions of neuronal
hyper-excitability, such as epilepsy and pain, are mechanistically
linked.
Collaborations:
–
Entered into a collaboration with Hydra Biosciences. The goal of the
collaboration is to advance development of Zalicus’ preclinical Ion
channel modulator product candidates into clinical development for the
treatment of pain. This collaboration brings together the Zalicus
portfolio of novel, preclinical Ion channel product candidates,
representing multiple calcium and sodium channel modulators, with
Hydra’s leadership in Ion channel discovery and preclinical drug
development. Hydra’s strong position in this area was recently
solidified with the progression into the clinic of its novel TRPA1
modulator for acute pain in collaboration with Cubist Pharmaceuticals.
Zalicus’ clinical-stage novel Ion channel modulators currently in
Phase 1 clinical development for pain, including Z-160, an N-type
calcium channel blocker and Z944, a novel T-type calcium channel
blocker, are not included in this collaboration.
2012 Zalicus Pipeline and Business Goals:
Zalicus has set the following goals for 2012, which include internal
research and development programs and collaborations:
–
Synavive(R):
–
Complete Phase 2b SYNERGY rheumatoid arthritis clinical trial and
report top-line data in the third quarter of 2012
–
Ion Channel Programs:
–
Complete Phase 1 PK evaluations of Z160 formulations and initiate
Phase 2 clinical study in 2012
–
Complete Phase 1 evaluation of Z944 and advance into Phase 2
clinical development
–
Identify new sodium channel development candidate or calcium
channel back-up compounds
–
Continue to execute on existing cHTS(TM) collaborations and secure new
partners
–
Target year-end ongoing financial strength
Fourth Quarter and Year-End 2011 Financial Results (Unaudited):
As of December 31, 2011, Zalicus had cash, cash equivalents, restricted
cash and short-term investments of $49.7 million compared to $46.5
million on December 31, 2010.
For the year ended December 31, 2011, revenue was $8.2 million compared
to $46.7 million for 2010. The decrease from the 2010 period was
primarily due to the receipt of a $40.0 million milestone payment from
Covidien in March 2010 related to the FDA approval of Exalgo. Zalicus
recognized $0.8 million in royalty revenue from Covidien based on
Exalgo(TM) sales for the fourth quarter ended December 31, 2011 and a total
of $4.1 million in Exalgo royalty revenue from its commercial launch in
April 2010 through December 31, 2011. We expect revenue for the year
ending December 31, 2012 to be higher than that recorded in the year
ended December 31, 2011, due to higher expected royalties on Covidien’s
net sales of Exalgo.
For the year ended December 31, 2011, net loss was $42.0 million, or
($0.43) per share, compared to a net loss of $35.0 million, or ($0.42)
per share, in the year ended December 31, 2010. Exalgo amortization
expense was $5.1 million for the year ended December 31, 2011 and $18.7
million in 2010. Stock-based compensation expense was $2.2 million and
$2.9 million in the years ended December 31, 2011, and 2010,
respectively. Depreciation expense was $2.1 million and $2.4 million in
the years ended December 31, 2011, and 2010, respectively.
Research and development expenses were $35.3 million in the year ended
December 31, 2011 compared to $23.0 million in the year ended December
31, 2010. The $12.3 million increase from the 2010 period to the 2011
period was primarily due to an increase in clinical development expenses
related to the initiation of Synavive, Z160 and Z944 clinical trials in
2011.
General and administrative expenses were $10.4 million in the year ended
December 31, 2011 compared to $12.1 million in the year ended December
31, 2010. The decrease was due primarily to one-time bonuses being paid
in 2010 related to the FDA approval of Exalgo.
About Zalicus
Zalicus Inc.
/quotes/zigman/120688/quotes/nls/zlcs ZLCS
+6.93%
is a biopharmaceutical company that
discovers and develops novel treatments for patients suffering from pain
and immuno-inflammatory diseases. Zalicus has a portfolio of proprietary
clinical-stage product candidates targeting pain and immuno-inflammatory
diseases and has entered into multiple revenue-generating collaborations
with large pharmaceutical companies relating to other products, product
candidates and drug discovery technologies. Zalicus applies its
expertise in the discovery and development of selective Ion channel
modulators and its combination high throughput screening capabilities to
discover innovative therapeutics for itself and its collaborators in the
areas of pain, inflammation, oncology and infectious disease. To learn
more about Zalicus, please visit
www.zalicus.com .
Forward-Looking Statement
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
concerning Zalicus, its product candidates, their potential and the
plans for their clinical development, the Zalicus selective Ion channel
modulation technology, and related preclinical product candidates,
Zalicus’ combination drug discovery technology, cHTS, and its financial
condition, results of operations, including expected 2012 royalties on
Covidien’s net sales of Exalgo, and other business plans. These
forward-looking statements about future expectations, plans, objectives
and prospects of Zalicus may be identified by words like “believe,”
“expect,” “may,” “will,” “should,” “seek,” “plan” or “could” and similar
expressions and involve significant risks, uncertainties and
assumptions, including risks related to the sale and marketing of Exalgo
by Covidien, risks related to the development and regulatory approval of
Zalicus’ product candidates, including risks relating to formulation and
clinical development of Synavive and Z160, the unproven nature of the
Zalicus drug discovery technologies, the ability of Covidien and Hydra
Biosciences to perform their obligations under their agreements with
Zalicus, the ability of the Company or its collaboration partners to
initiate and successfully complete clinical trials of its product
candidates, the Company’s ability to obtain additional financing or
funding for its research and development and those other risks that can
be found in the “Risk Factors” section of Zalicus’ annual report on Form
10-K on file with the Securities and Exchange Commission and the other
reports that Zalicus periodically files with the Securities and Exchange
Commission. Actual results may differ materially from those Zalicus
contemplated by these forward-looking statements. These forward-looking
statements reflect management’s current views and Zalicus does not
undertake to update any of these forward-looking statements to reflect a
change in its views or events or circumstances that occur after the date
of this release except as required by law.
(c) 2012 Zalicus Inc. All rights reserved.
Zalicus Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(Unaudited)
Three months Twelve months ended
ended December 31, December 31,
—————————– ——————————–
2011 2010 2011 2010
Revenue:
Collaborations and other $ 2,553 $ 1,174 $ 7,595 $ 45,969
Government contracts and grants 84 143 589 772
———- ———- ———- ———-
Total revenue 2,637 1,317 8,184 46,741
———- ———- ———- ———-
Operating expenses:
Research and development 9,616 5,951 35,294 23,011
General and administrative 2,370 2,856 10,400 12,115
Amortization of intangible 1,286 4,684 5,141 18,736
———- ———- ———- ———-
Total operating expenses 13,272 13,491 50,835 53,862
———- ———- ———- ———-
Loss from operations (10,635) (12,174) (42,651) (7,121)
Interest income 36 40 136 132
Interest expense (397) (12) (976) (12)
Loss on revaluation of contingent consideration — — — (29,286)
Other income 18 177 20 32
———- ———- ———- ———-
Net loss before provision for income taxes (10,978) (11,969) (43,471) (36,255)
Benefit for income taxes 211 — 1,428 1,210
———- ———- ———- ———-
Net loss $ (10,767) $ (11,969) $ (42,043) $ (35,045)
=== ========== === ========== === ========== === ========== ===
Net loss per share–basic and diluted $ (0.11) $ (0.13) $ (0.43) $ (0.42)
=== ========== === ========== === ========== === ========== ===
Weighted average number of common shares used in net
loss per
share calculation:
Basic 99,231,443 89,031,018 97,347,193 82,663,645
========== ========== ========== ==========
Diluted 99,231,443 89,031,018 97,347,193 82,663,645
========== ========== ========== ==========
Zalicus Inc.
Condensed Consolidated Balance Sheets
(in thousands, except per share data)
(Unaudited)
Assets
Current assets:
Cash and cash equivalents $ 2,750 $ 2,820
Restricted cash 50 650
Short-term investments 45,124 41,799
Accounts receivable 1,886 1,605
Prepaid expenses and other current assets 1,397 965
-------- --------
Total current assets 51,207 47,839
Property and equipment, net 5,258 6,898
Intangible asset, net 21,546 26,687
Restricted cash and other assets 1,872 1,245
-------- --------
Total assets $ 79,883 $ 82,669
= ======== = ========
Liabilities and stockholders' equity
Current liabilities:
Accounts payable $ 1,743 $ 1,840
Accrued expenses and other current liabilities 6,133 4,269
Deferred revenue 3,349 2,370
Current portion of term loan payable 4,035 273
Current portion of lease incentive obligation 284 284
-------- --------
Total current liabilities 15,544 9,036
Term loan payable, net of current portion 15,099 2,523
Deferred revenue, net of current portion 3,000 3,667
Deferred rent, net of current portion 605 743
Lease incentive obligation, net of current portion 1,159 1,442
Other long-term liabilities 563 2,261
Stockholders' equity:
-- --
Preferred stock, $0.001 par value; 5,000 shares authorized; no
shares issued and
outstanding
99 89
Common stock, $0.001 par value; 200,000 shares authorized; 99,239
and 89,113 shares
issued and outstanding at December 31, 2011
and 2010, respectively
Additional paid-in capital 340,518 317,581
Accumulated other comprehensive loss (8) (20)
Accumulated deficit (296,696) (254,653)
-------- - -------- -
Stockholders' equity 43,913 62,997
-------- --------
Total liabilities and stockholders' equity $ 79,883 $ 82,669
= ======== = ========
SOURCE: Zalicus Inc.
Zalicus Inc.
Justin Renz, 617-301-7575
CFO
JRenz@zalicus.com
or
Gina Nugent, 617-460-3579
gnugent@zalicus.com
Copyright Business Wire 2012
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ZLCS
Zalicus Inc.
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Volume: 1.09M
March 8, 2012 4:00p
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Add ZLCS to portfolio
ZLCS
Zalicus Inc.
$
1.08
+0.07
+6.93%
Volume: 1.09M
March 8, 2012 4:00p