Conference call begins at 4:30 p.m. Eastern time today
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today
announced financial results for the three and six months ended June 30,
2008 and provided an update on key programs.
Second Quarter Results
Total revenues from continuing operations for the second quarter of 2008
were $4.8 million, compared with $1.4 million for the second quarter of
2007.
Operating costs and expenses for the second quarter of 2008 were $10.9
million, compared with $16.3 million for the same 2007 period. The loss
from continuing operations for the second quarter of 2008 was $4.9
million, or $0.05 per share, compared with a loss from continuing
operations of $7.7 million, or $0.08 per share, for the second quarter
of 2007. The Company reported a loss from discontinued operations in the
second quarter of 2008 of $1.5 million, or $0.02 per share, compared
with income from discontinued operations of $7.9 million, or $0.08 per
share, in the comparable 2007 quarter.
The total net loss for the second quarter of 2008 was $6.4 million, or
$0.07 per share, compared with net income of $0.2 million, or $0.00 per
share, in the second quarter of 2007.
As of June 30, 2008, Ligand had cash, cash equivalents, short-term
investments and restricted investments of $86.4 million. In addition,
$10.2 million of cash is held in a trust account to support potential
indemnifiable claims on behalf of certain current and former members of
Ligand’s Board of Directors.
“Ligand remains committed to a focused
operating model while we advance the development of our pipeline of
innovative products. We are pleased with our progress during the second
quarter,” said John L. Higgins, President and
Chief Executive Officer of Ligand Pharmaceuticals. “We
have collaborations with leading pharmaceutical companies, including
GlaxoSmithKline, Wyeth and Pfizer. Each of these companies has a New
Drug Application (NDA) pending FDA review for drugs that are expected to
fill important needs in a variety of medical indications. In addition,
we continue to advance our TPO mimetic, LGD-4665, and have made progress
toward filing an IND for our lead SARM candidate.”
Year-to-Date Results
Total revenues for the six months ended June 30, 2008, were $9.7
million, compared with $1.6 million for the first six months of 2007.
Operating costs and expenses for the first six months of 2008 were $28.2
million, compared with $46.0 million for the same period in 2007.
The total net loss for the six months ended June 30, 2008, was $10.4
million, or $0.11 per share, compared with net income of $274.5 million,
or $2.74 per share, for the same period in 2007.
Ligand Pipeline Update
LGD-4665 –
TPO Mimetic:
Ligand is in the process of completing a series of Phase I pharmacology
studies to further define drug activity in healthy volunteers. Ligand
anticipates announcing data from these studies at the American Society
of Hematology Conference in December. In addition, Ligand initiated a
Phase II trial in ITP (immune thrombocytopenia purpura) in April and
anticipates initiating a Phase II trial for treatment-induced
thrombocytopenia in MDS (myelodysplastic syndrome) patients in the third
quarter and is developing plans for a Phase II trial in patients with
hepatitis C.
Selective Androgen Receptor Modulators
(SARM):
Ligand continues to conduct preclinical work on potential SARM
candidates, and expects to file an Investigational New Drug (IND)
application for its lead SARM, LGD-4033, in the fourth quarter of 2008.
EPO Mimetic:
Ligand is optimizing potential lead compounds as small-molecule, oral
erythropoietin (EPO) mimetics. Since the beginning of 2008, Ligand has
made considerable progress toward the discovery of potent orally active
EPO drugs.
Partnered Program Update
GlaxoSmithKline –
TPO Mimetic, Eltrombopag:
The FDA has extended the priority review period for GlaxoSmithKline’s
NDA for PROMACTA® (eltrombopag) for the
short-term treatment of chronic ITP. The original PDUFA date of June 19,
2008 has been extended to September 19, 2008. GSK submitted an NDA for
PROMACTA in December 2007. In March 2008, the FDA granted the drug
Priority Review, and in May 2008, orphan drug designation was also
granted for this indication. On May 30, 2008, the FDA’s
Oncology Drugs Advisory Committee (ODAC) panel unanimously voted (16-0)
that eltrombopag demonstrated a favorable risk-benefit profile for the
short-term treatment of patients with chronic ITP. GSK is currently
conducting two Phase III trials in hepatitis C, a Phase I trial in
sarcoma and Phase II trials in chemotherapy-induced thrombocytopenia,
and expects MAA and NDA submissions for the long-term treatment of ITP
in 2008.
Wyeth –
SERM (selective estrogen receptor modulator), Bazedoxifene:
VIVIANT™ (bazedoxifene): Wyeth received an
approvable letter in May 2008 for the treatment of postmenopausal
osteoporosis. Wyeth expects to file a complete response with the FDA by
year-end to address the Agency’s questions.
In September 2007, an MAA was submitted in Europe for VIVIANT for the
treatment and prevention of osteoporosis.
APRELA™ (bazedoxifene CE): Wyeth met with the
FDA in early 2008 to review the results from the Phase III clinical
trials and discuss the planned NDA filing. The filing still requires
some formulation and other work to be completed before submission of an
NDA.
Pfizer –
SERM, Lasofoxifene:
Ligand’s partner Pfizer submitted an MAA
(European filing) for FABLYN® (lasofoxifene)
for osteoporosis treatment in January 2008. An NDA for FABLYN for
osteoporosis treatment was submitted in the fourth quarter of 2007.
2008 Operating Forecast
Affirming its previous 2008 revenue forecast, Ligand expects to receive
approximately $20 million in royalty revenue for the full year from King
Pharmaceuticals for sales of AVINZA® and
potential milestone payments from existing corporate partners. For the
remaining half of 2008, the Company anticipates total operating costs
will be between $17 and $20 million including stock-based compensation
and $1.0 million of amortization of deferred gain on sale leaseback.
This estimate is consistent with the Company’s
revised 2008 forecast provided on May 1, 2008.
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 participate via telephone
please dial (877) 356-5578 from the U.S. or (706) 679-0565 from outside
the U.S. A replay of the call will be available until August 31, 2008 at
5:30 p.m. Eastern time by dialing (800) 642-1687 from the U.S. or (706)
645-9291 from outside the U.S., and entering passcode 55282270.
Individual investors can access the live and archived Webcast through
Ligand’s web site at www.ligand.com.
About Ligand Pharmaceuticals
Ligand discovers and develops new drugs that address critical unmet
medical needs of patients with thrombocytopenia, hepatitis C,
hormone-related diseases, osteoporosis, inflammatory diseases and
anemia. Ligand's proprietary drug discovery and development programs are
based on its leadership position in gene transcription technology.
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 also may not receive expected royalties on AVINZA®
from King Pharmaceuticals or any other partnered products or from
research and development milestones. In addition, our partners may
change their plans or timetables regarding our partnered products and
expected regulatory actions (e.g., filings, approvals, etc.) may be
delayed or may not occur. Any payments expected from third parties may
not be received by us due to third party intellectual property or
contract restrictions and any amounts received by us may be subject to
third party claims. We may not be able to timely or successfully advance
any product(s) in our pipeline, for example, LGD-4665, LGD-4033 and our
oral EPO drug candidates. In addition, we may have indemnification
obligations to King Pharmaceuticals or Eisai in connection with the
sales of the AVINZA and oncology product lines. In addition, we may not
be able to successfully implement our strategy, and continue the
development of our proprietary programs. The failure to meet
expectations with respect to any of the foregoing matters may reduce our
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.
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LIGAND PHARMACEUTICALS INCORPORATED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except share data)
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Three Months
Ended June 30,
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Six Months
Ended June 30,
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2008
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2007
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2008
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2007
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Revenues:
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|
|
|
|
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Royalties
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$
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4,804
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|
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$
|
1,410
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|
|
$
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9,678
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$
|
1,410
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Collaborative research and development and other revenues
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—
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—
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—
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235
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Total revenues
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4,804
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1,410
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9,678
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|
|
|
1,645
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Operating costs and expenses:
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Research and development
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6,377
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|
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8,751
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13,542
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24,353
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General and administrative
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4,551
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7,516
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14,650
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21,683
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Total operating costs and expenses
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10,928
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16,267
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28,192
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46,036
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Accretion of deferred gain on sale leaseback
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491
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491
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982
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|
982
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Loss from operations
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(5,633
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)
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(14,366
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)
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(17,532
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)
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(43,409
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)
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Other income (expense), net
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(286
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)
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2,455
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|
115
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5,415
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Income tax benefit
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1,030
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|
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4,225
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2,811
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|
|
|
13,419
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Loss from continuing operations
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(4,889
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)
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(7,686
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)
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(14,606
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)
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(24,575
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)
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Discontinued operations, net of taxes
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(1,540
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)
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7,867
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4,244
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|
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299,077
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Net income (loss)
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$
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(6,429
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)
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$
|
181
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$
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(10,362
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)
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$
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274,502
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Basic and diluted per share amounts:
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Loss from continuing operations
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$
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(0.05
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)
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$
|
(0.08
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)
|
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$
|
(0.15
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)
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|
$
|
(0.24
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)
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Discontinued operations
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(0.02
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)
|
|
|
0.08
|
|
|
|
0.04
|
|
|
|
2.98
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Net income (loss)
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|
$
|
(0.07
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)
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|
$
|
0.00
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|
$
|
(0.11
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)
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$
|
2.74
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Weighted average number of common shares
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95,055,718
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99,878,197
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95,051,672
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100,279,949
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LIGAND PHARMACEUTICALS INCORPORATED
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
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June 30, 2008
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December 31, 2007
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Assets
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Current assets:
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Cash, cash equivalents, short-term investments, and restricted cash
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$
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84,996
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$
|
94,408
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Other current assets
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2,434
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|
|
5,068
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Current portion of co-promote termination asset
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8,682
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|
|
10,467
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Total current assets
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96,112
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|
|
109,943
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|
|
|
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Restricted investments
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1,411
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|
|
1,411
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Property and equipment, net
|
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|
2,024
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|
|
2,865
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Long-term portion of co-promote termination asset
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50,298
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|
|
48,989
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Other assets
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10,178
|
|
|
10,070
|
|
|
|
$
|
160,023
|
|
$
|
173,278
|
|
|
|
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Liabilities and Stockholders' Equity
|
|
|
|
|
|
|
|
|
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|
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Accounts payable and accrued liabilities
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|
$
|
32,988
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|
$
|
37,009
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Current portion of deferred gain
|
|
|
1,964
|
|
|
1,964
|
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Current portion of co-promote termination liability
|
|
|
8,682
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|
|
10,467
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Current portion of debt
|
|
|
978
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|
|
1,528
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Total current liabilities
|
|
|
44,612
|
|
|
50,968
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Long-term portion of debt
|
|
|
266
|
|
|
627
|
|
Long-term portion of co-promote termination liability
|
|
|
50,298
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|
|
48,989
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Long-term portion of deferred gain
|
|
|
24,274
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|
|
25,256
|
|
Other long-term liabilities
|
|
|
9,207
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|
|
5,978
|
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Total liabilities
|
|
|
128,657
|
|
|
131,818
|
|
Common stock subject to conditional redemption
|
|
|
12,345
|
|
|
12,345
|
|
Stockholders' equity
|
|
|
19,021
|
|
|
29,115
|
|
|
|
$
|
160,023
|
|
$
|
173,278
|
Ligand Pharmaceuticals Incorporated
John L. Higgins, President and
CEO
Erika Luib, Investor Relations
858-550-7896
or
Lippert/Heilshorn
& Associates
Don Markley
310-691-7100
dmarkley@lhai.com