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| [February 13, 2013] |
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Ligand Reports Fourth Quarter and Full Year 2012 Financial Results
SAN DIEGO --(Business Wire)--
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today
announced financial results for the three and 12 months ended December
31, 2012 and reviewed business highlights for the fourth quarter of 2012
and early 2013. Ligand's 2012 Form 10-K is expected to be filed before
March 12, 2013. Financial information related to contingent value rights
contained in this news release is being finalized and is therefore
subject to adjustment.
"2012 was a transformational year for Ligand. Our operations reached
profitability and positive cash-flow by year-end, and progress made in
our late-stage partnered and unpartnered programs demonstrated the
tremendous potential of our unique business model," commented John
Higgins, President and Chief Executive Officer of Ligand. "We are very
pleased with the continued revenue growth of Promacta®,
partnered with GlaxoSmithKline, and believe the approval of Onyx's drug
Kyprolis® in 2012 is a significant event for Ligand and our
Captisol® business. Today, we have seven drugs generating
royalties, with a potential for six more royalty-bearing products to be
approved in the next three years. We expect to see continued advancement
of our pipeline as well as revenue and net income growth in 2013 and
beyond."
Fourth Quarter Financial Results
Total revenues from continuing operations for the fourth quarter of 2012
were $13.6 million, compared with $12.9 million for the fourth quarter
of 2011. The $0.7 million increase is primarily due to higher royalty
revenues from increased sales of Promacta, partially offset by lower
Captisol sales and license and milestone revenues.
Cost of goods sold was $2.3 million for the fourth quarter of 2012, an
increase of $0.3 million compared with the fourth quarter of 2011. Other
operating costs and expenses from continuing operations for the fourth
quarter of 2012 were $6.9 million, compared with other operating costs
and expenses of $6.5 million for the fourth quarter of 2011. Research
and development expenses of $2.5 million were roughly flat compared with
the fourth quarter of 2011. General and administrative expenses were
$4.3 million, an increase of $0.6 million compared with the fourth
quarter of 2011, primarily due to costs associated with tax consulting
projects.
Net income for the fourth quarter of 2012 was $1.1 million, or $0.05 per
share, compared with net income for the fourth quarter of 2011 of $4.7
million, or $0.24 per share. Excluding an increase in liability for
contingent value rights of $2.8 million, or $0.14 per share, for the
fourth quarter of 2012 and a decrease in liability for contingent value
rights of $0.3 million, or $0.02 per share, for the fourth quarter of
2011, net income for the fourth quarter of 2012 was $3.9 million, or
$0.19 per share, compared with net income for the fourth quarter of 2011
of $4.4 million, or $0.22 per share.
Income from continuing operations for the fourth quarter of 2012 was
$2.6 million, or $0.13 per share, compared with income from continuing
operations for the fourth quarter of 2011 of $4.7 million, or $0.24 per
share. Excluding the increase in liability for contingent value rights
of $2.8 million, or $0.14 per share, for the fourth quarter of 2012 and
a decrease in liability for contingent value rights of $0.3 million, or
$0.02 per share, for the fourth quarter of 2011, income from continuing
operations for the fourth quarter of 2012 was $5.4 million, or $0.27 per
share, compared with income from continuing operations for the fourth
quarter of 2011 of $4.4 million, or $0.22 per share.
As of December 31, 2012, Ligand had cash, cash equivalents, short-term
investments and restricted investments of $15.1 million and accounts
receivable of $4.6 million.
Full-Year Financial Results
Total revenues for 2012 were $31.4 million, compared with $30.0 million
for 2011. Cost of goods sold was $3.6 million for 2012, compared to $4.9
million in 2011. Other operating costs and expenses for 2012 were $27.2
million, including $6.8 million in non-cash expense items, compared with
other operating costs and expenses for 2011 of $27.5 million, including
a $2.3 million write-off of in-process research and development for
discontinued programs.
The net loss for 2012 was $0.5 million, or $0.03 per share, compared
with net income for 2011 of $9.7 million, or $0.49 per share. Net income
for 2011 included a $13.3 million income tax benefit. Excluding the
increase in liability for contingent value rights of $1.7 million, or
$0.08 per share, for 2012 and $1.0 million, or $0.05 per share, for
2011, net income for 2012 was $1.1 million, or $0.06 per share, compared
with net income for 2011 of $10.7 million, or $0.55 per share.
The loss from continuing operations for 2012 was $2.7 million, or $0.13
per share, compared with income from continuing operations for 2011 of
$9.7 million, or $0.49 per share. Excluding the increase in liability
for contingent value rights of $1.7 million, or $0.08 per share, for
2012 and an increase in liability for contingent value rights of $1.0
million, or $0.05 per share, for 2011, the loss from continuing
operations for 2012 was $1.0 million, or $0.05 per share, compared with
income from continuing operations for 2011 of $10.7 million, or $0.55
per share.
2013 Operating Forecast
For 2013 Ligand expects total revenues to be in the range of $41 million
to $44 million and combined research and development and general and
administrative expenses to be approximately $27 million, including
approximately $7 million of non-cash expense items. Net income per share
for 2013 is expected to be in the range of $0.35 to $0.39.
Fourth Quarter and Recent Business Highlights
-
Ligand partner GlaxoSmithKline announced that the FDA approved
Promacta for the treatment of thrombocytopenia (low blood platelet
counts) in patients with chronic hepatitis C to allow them to initiate
and maintain interferon-based therapy. Promacta is the first
supportive care treatment available to patients who are ineligible or
poor candidates for interferon-based therapy due to low blood platelet
counts. Promacta in combination with interferon-based therapy has been
shown to improve a patient's ability to achieve sustained virologic
response or viral cure.
-
GlaxoSmithKline received marketing approval for Promacta for the
treatment of chronic idiopathic thrombocytopenia in Bangladesh.
Promacta is now approved for sale in 92 countries worldwide.
-
Ligand initiated a pivotal trial of Captisol-enabled, propylene
glycol-free (PG-free) high-dose melphalan as a conditioning treatment
prior to autologous stem cell transplant for patients with multiple
myeloma. This multi-center trial will evaluate safety and efficacy in
60 patients, and is intended to confirm the results from an earlier
Phase 2a study demonstrating that the PG-free melphalan intravenous
formulation was safe and well-tolerated, and met the requirements for
establishment of bioequivalence to the current commercial intravenous
formulation of melphalan (sold by GlaxoSmithKline as Alkeran®
for Injection).
-
Ligand partner Pfizer announced that the FDA accepted for review a New
Drug Application (NDA) for bazedoxifene/conjugated estrogens (BZA/CE),
a potential new medicine for non-hysterectomized women for the
treatment of moderate-to-severe vasomotor symptoms and vulvar and
vaginal atrophy associated with menopause, as well as the prevention
of postmenopausal osteoporosis. The FDA Prescription Drug User Fee Act
(PDUFA) date is October 3, 2013.
-
Ligand presented preclinical data on LG-7501 at the 63rd
Annual Meeting of the American Association for the Study of Liver
Diseases. LG-7501 is a small molecule inhibitor of NS5B polymerase for
the treatment of hepatitis C virus infection, which uses Ligand's
HepDirect™ liver-targeting technology platform.
-
Ligand received a milestone payment of 620,000 shares of common stock
in partner Retrophin, Inc., valued at approximately $1.4 million as of
the transaction date and as of December 31, 2012, under the previously
executed license agreement for the development and commercialization
of Retrophin's lead clinical candidate RE-021, formerly known as DARA
(a Dual Acting Receptor Antagonist of Angiotensin and Endothelin
receptors). Receipt of this milestone was triggered by the completion
of Retrophin's merger with Desert Gateway, Inc. and its transition to
a publicly traded company.
-
Investigators reported additional data from Ligand's successfully
completed Phase 2a study of Captisol-enabled, PG-free melphalan, which
will be presented this evening in a poster session at the 2013 BMT
Tandem Meetings Conference in Salt Lake City.
Non-GAAP Financial Measures
The adjusted non-GAAP (U.S. Generally Accepted Accounting Principles)
financial measures discussed above for the quarters and years ended
December 31, 2012 and 2011 exclude expenses related to the increase in
liability for contingent value rights.
Management has presented net income, net income per share, income from
continuing operations and income from continuing operations per share in
accordance with GAAP and on an "adjusted" basis for the quarters and
years ended December 31, 2012 and 2011. Ligand believes that the
presentation of non-GAAP financial measures provides useful
supplementary information to and facilitates additional analysis by
investors. Ligand uses these non-GAAP financial measures in connection
with its own budgeting and financial planning. These non-GAAP financial
measures are in addition to, not a substitute for, or superior to,
measures of financial performance prepared in conformity with GAAP.
Conference Call
Ligand management will host a conference call today beginning at 4:30
p.m. Eastern time (1:30 p.m. Pacific time) to discuss this announcement
and answer questions. To participate via telephone, please dial (877)
407-4019 from the U.S. or (201) 689-8337 from outside the U.S., using
the passcode "Ligand." A replay of the call will be available until
March 12, 2013 at 5:30 p.m. Eastern time by dialing (877) 660-6853 from
the U.S. or (201) 612-7415 from outside the U.S., using passcode is
407649. Individual investors can access the Webcast through Ligand's web
site at www.ligand.com.
About Ligand Pharmaceuticals
Ligand is a biopharmaceutical company that develops and acquires assets
it believes will generate royalty revenues and, under its lean corporate
cost structure, produce sustainable profitability. Ligand has a diverse
asset portfolio addressing the unmet medical needs of patients for a
broad spectrum of diseases including thrombocytopenia, multiple myeloma,
diabetes, hepatitis, muscle wasting, dyslipidemia, anemia and
osteoporosis. Ligand's Captisol platform technology is a
patent-protected, chemically modified cyclodextrin with a structure
designed to optimize the solubility and stability of drugs. Ligand has
established multiple alliances with the world's leading pharmaceutical
companies including GlaxoSmithKline, Merck, Pfizer, Eli Lilly & Company,
Baxter International, Bristol-Myers Squibb, Celgene, Onyx
Pharmaceuticals, Lundbeck Inc. and The Medicines Company, among others.
Please visit www.captisol.com
for more information on Captisol or www.ligand.com
for more information on Ligand.
Follow Ligand on Twitter @Ligand_LGND.
Forward-Looking Statements
This news release contains certain forward-looking statements by Ligand
that involve risks and uncertainties and reflect Ligand's judgment as of
the date of this release. Actual events or results may differ from
Ligand's expectations. For example, we may not receive expected revenue
from material sales of Captisol, expected royalties on partnered
products or from research and development milestones may not be
received, and we and our partners may not be able to timely or
successfully advance any product(s) in Ligand's internal or partnered
pipeline. In addition, there can be no assurance that Ligand will
achieve its guidance for 2013 or beyond, that Ligand will deliver strong
cash flow over the long-term, that Ligand's 2013 revenues will be at the
levels or be broken down as currently anticipated or that Captisol sales
will be sufficiently strong, that Ligand will be able to create future
revenues and cash flows by developing innovative therapeutics, that
results of any clinical study will be timely, favorable or confirmed by
later studies, that products under development by Ligand or its partners
will receive regulatory approval, or that there will be a market for the
product(s) if successfully developed and approved. Also, Ligand and its
partners may experience delays in the commencement, enrollment,
completion or analysis of clinical testing for its product candidates,
or significant issues regarding the adequacy of its clinical trial
designs or the execution of its clinical trials, which could result in
increased costs and delays, or limit Ligand's ability to obtain
regulatory approval. Further, unexpected adverse side effects or
inadequate therapeutic efficacy of Ligand's product(s) could delay or
prevent regulatory approval or commercialization. Ligand may also have
indemnification obligations to King Pharmaceuticals or Eisai in
connection with the sales of the Avinza and oncology product lines. In
addition, Ligand may not be able to successfully implement its strategic
growth plan and continue the development of its proprietary programs.
The failure to meet expectations with respect to any of the foregoing
matters may reduce Ligand's stock price. Additional information
concerning these and other risk factors affecting Ligand's business can
be found in prior press releases available via www.ligand.com
as well as in Ligand's public periodic filings with the Securities and
Exchange Commission at www.sec.gov.
Ligand disclaims any intent or obligation to update these
forward-looking statements beyond the date of this release. This caution
is made under the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995.
[Tables to follow]
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LIGAND PHARMACEUTICALS INCORPORATED
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
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(in thousands, except share data)
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�
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�
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Three Months Ended December 31,
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�
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Twelve Months Ended December 31,
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�
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2012
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�
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�
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�
|
2011
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�
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|
�
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2012
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�
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�
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�
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2011
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�
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(unaudited)
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(unaudited)
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Revenues:
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Royalties
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$
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4,817
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$
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2,616
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$
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14,073
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$
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9,213
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Material sales
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5,282
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|
|
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6,460
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9,432
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12,123
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Collaborative research and development and other revenues
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�
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3,536
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�
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�
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3,861
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�
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�
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7,883
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�
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�
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8,701
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�
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Total revenues
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13,635
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12,937
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31,388
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30,037
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�
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Operating costs and expenses:
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Cost of goods sold
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2,328
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2,059
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3,601
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4,909
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Research and development
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2,476
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2,599
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10,790
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10,291
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General and administrative
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4,283
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3,709
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16,108
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14,977
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Write-off of in-process research and development
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-
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-
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-
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2,282
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Lease exit and termination costs
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�
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156
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�
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�
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147
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�
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�
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315
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�
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�
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(22
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)
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Total operating costs and expenses
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9,243
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8,514
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30,814
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32,437
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Amortization of deferred gain on sale leaseback
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�
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-
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�
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�
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426
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�
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�
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�
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-
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�
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�
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�
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1,702
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�
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Gain (loss) from operations
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4,392
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4,849
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574
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(698
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)
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Other income (expense), net
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(601
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)
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(174
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)
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(2,789
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)
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(1,847
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)
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Decrease (increase) in contingent liabilities
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(2,841
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)
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|
304
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|
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(1,650
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)
|
|
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(1,013
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)
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Income tax (expense) benefit
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|
�
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1,636
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�
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|
�
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(289
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)
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|
�
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1,191
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�
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|
�
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13,270
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�
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|
Income (loss) from continuing operations
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�
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2,586
|
�
|
|
�
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4,690
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�
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|
�
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(2,674
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)
|
|
�
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9,712
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�
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|
Income (loss) from discontinued operations, net of taxes
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|
�
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(1,523
|
)
|
|
�
|
-
|
�
|
|
�
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2,147
|
�
|
|
�
|
3
|
�
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Net income
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$
|
1,063
|
�
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|
$
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4,690
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�
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|
$
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(527
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)
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$
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9,715
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�
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Basic and diluted per share amounts:
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|
|
|
|
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|
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Income (loss) from continuing operations
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$
|
0.13
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|
|
$
|
0.24
|
|
|
$
|
(0.13
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)
|
|
$
|
0.49
|
|
|
Discontinued operations
|
|
�
|
(0.08
|
)
|
|
�
|
-
|
�
|
|
�
|
0.11
|
�
|
|
�
|
-
|
�
|
|
Net income
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|
$
|
0.05
|
�
|
|
$
|
0.24
|
�
|
|
$
|
(0.03
|
)
|
|
$
|
0.49
|
�
|
|
|
|
|
|
|
|
|
|
�
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Weighted average number of common shares-basic
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20,034,558
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19,674,945
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|
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19,853,095
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|
|
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19,655,632
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Weighted average number of common shares-diluted
|
|
|
20,124,331
|
|
|
|
19,738,228
|
|
|
|
19,853,095
|
|
|
|
19,713,320
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