Conference call begins at 4:30 p.m. Eastern time today
SAN DIEGO--(BUSINESS WIRE)--
Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) today announced
financial results for the three and six months ended June 30, 2012 and
provided an update on key programs.
“The strength of our business model and our product pipeline was
demonstrated in the recent announcements by Onyx Pharmaceuticals of the
approval of Captisol-enabled Kyprolis™, and by GlaxoSmithKline regarding
the FDA’s priority review of Promacta® for the treatment of
thrombocytopenia in adult patients with chronic hepatitis C. We look
forward to continued commercial, regulatory and clinical progress by our
partners and our team during the remainder of the year,” said John
Higgins, President and Chief Executive Officer of Ligand. “We are
pleased with the financial performance of the business and believe our
strong growth prospects are coming into focus given the significant
positive events over the past few months.”
Second Quarter Results
Total revenues for the second quarter of 2012 were $5.7 million,
compared with $7.5 million for the same period in 2011. The decrease in
revenues was due primarily to timing of customer purchases of Captisol
this year and recognition of $1.3 million of non-cash deferred revenue
relating to Fablyn in the second quarter 2011. Royalties for the second
quarter of 2012 increased $0.8 million compared with the second quarter
of 2011, primarily due to an increase in Promacta sales.
Total operating costs and expenses for the second quarter of 2012 were
$7.5 million, compared with $8.7 million for the second quarter of 2011.
Cost of goods sold was $0.4 million, compared with $1.6 million for the
second quarter of 2011. Research and development expenses declined by
$0.4 million, primarily due to timing of expenses related to internal
research and development projects. General and administrative expenses
were essentially flat and lease exit and termination expenses increased
$0.2 million, all compared with the same quarter a year ago.
The net loss in the second quarter of 2012 was $2.3 million, or ($0.11)
per share, compared with a net loss of $0.9 million, or ($0.05) per
share, in the second quarter of 2011. The loss from continuing
operations for the second quarter of 2012 was $4.1 million, or ($0.20)
per share, compared with a loss from continuing operations of $0.9
million, or ($0.05) per share for the second quarter of 2011. Income
from discontinued operations for the second quarter of 2012 was $1.8
million, or $0.09 per share.
As of June 30, 2012, Ligand had cash, cash equivalents, short-term
investments and restricted investments of $11.7 million.
Year-to-Date Results
Total revenues for the six months ended June 30, 2012 were $11.4
million, compared with $11.4 million for the first six months of 2011.
Cost of goods sold was $0.6 million for the first six months of 2012,
compared with $2.1 million for the first six months of 2011. Other
operating costs and expenses for the first six months of 2012 were $13.3
million, compared with $12.4 million for the first six months of 2011.
The net loss for the first six months of 2012 was $0.9 million, or
($0.04) per share, compared with net income of $9.1 million, or $0.46
per diluted share, for the first six months of 2011. The net loss from
continuing operations for the first half of 2012 was $4.6 million, or
($0.23) per share, compared with net income from continuing operations
of $9.1 million, or $0.46 per diluted share, for the comparable 2011
period. Net income and income from continuing operations for the first
half of 2011 include a $13.4 million income tax benefit. Net income from
discontinued operations for the first six months of 2012 was $3.7
million, or $0.19 per share.
Second Quarter and Recent Partner Highlights
-
Ligand partner GlaxoSmithKline announced that it has been granted
priority review from the U.S. Food and Drug Administration (FDA) for
the supplemental new drug application for Promacta to treat
thrombocytopenia in adult patients with chronic hepatitis C virus
(HCV) infection.
-
Captisol licensee Onyx Pharmaceuticals received accelerated approval
from the FDA for Kyprolis (carfilzomib) for injection, a proteasome
inhibitor indicated for the treatment of patients with multiple
myeloma who have received at least two prior therapies, including
bortezomib and an immunomodulatory agent, and have demonstrated
disease progression on or within 60 days of completion of the last
therapy.
-
Ligand partner Pfizer announced that the European Medicines Agency
(EMA) accepted for review the Marketing Authorization Application
(MAA) for bazedoxifene/conjugated estrogens, a potential new medicine
for postmenopausal women with a uterus for the treatment of estrogen
deficiency symptoms and treatment of osteoporosis in women at risk of
fracture. Pfizer expects a decision from the EMA in 2013.
-
Ligand entered into a clinical-stage Captisol agreement with Vertex
Pharmaceuticals.
-
Ligand announced positive preclinical data on LGD-6972, a
small-molecule glucagon receptor antagonist for the treatment of
type-2 diabetes, at the American Diabetes Association’s 72nd
Scientific Sessions in June.
2012 Operating Forecast
Affirming its previous forecast, Ligand expects 2012 total revenues to
be approximately $30 million, with revenue in the third quarter of
approximately $8 million and revenue in the fourth quarter of
approximately $11 million. Revenue for the second half of the year may
fluctuate significantly between the third and fourth quarter based on
the timing of license payments and customer purchases of Captisol. The
Company continues to expect combined research and development and
general and administrative expenses of approximately $25 million during
2012, including approximately $6 million of non-cash expense items.
Additionally, the Company continues to expect its operations to be
profitable and cash-flow positive for the year.
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
September 8, 2012 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. The account number
is 361 and the passcode is 396983. Individual investors can access the
Webcast through Ligand’s web site at www.ligand.com.
About Ligand Pharmaceuticals
Ligand is a biopharmaceutical company with a business model that is
based upon the concept of developing or acquiring royalty revenue
generating assets and coupling them to a lean corporate cost structure.
Ligand’s goal is to produce a bottom line that supports a sustainably
profitable business. By diversifying the portfolio of assets across
numerous technology types, therapeutic areas, drug targets, and industry
partners, we offer investors an opportunity to invest in the
increasingly complicated and unpredictable pharmaceutical industry. In
comparison to its peers, we believe Ligand has assembled one of the
largest and most diversified asset portfolios in the industry with the
potential to generate revenue in the future. These therapies address the
unmet medical needs of patients for a broad spectrum of diseases
including diabetes, hepatitis, muscle wasting, thrombocytopenia,
dyslipidemia, anemia, multiple myeloma 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., The Medicines
Company, Curis, Inc. and Rib-X Pharmaceuticals. Please visit www.captisol.com
for more information on Captisol. For more information on Ligand, please
visit www.ligand.com.
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 be profitable or
cash-flow positive before the end of 2012, we may not receive expected
revenue from material sales of Captisol, we may not be able to
effectively integrate CyDex’s business into our current business,
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 2012 or beyond, that Ligand
will deliver strong cash flow over the long-term, that Ligand will
realize the expected benefits of the acquisition of CyDex, that Ligand's
2012 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.
|
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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2012
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2011
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2012
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2011
|
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Revenues:
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|
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|
|
|
|
|
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Royalties
|
$
|
2,983
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|
|
$
|
2,172
|
|
|
$
|
6,043
|
|
|
$
|
4,165
|
|
|
|
Material sales
|
|
1,665
|
|
|
|
2,984
|
|
|
|
2,332
|
|
|
|
4,034
|
|
|
|
Collaborative research and development and other revenues
|
|
1,094
|
|
|
|
2,307
|
|
|
|
3,003
|
|
|
|
3,160
|
|
|
|
Total revenues
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|
5,742
|
|
|
|
7,463
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|
|
|
11,378
|
|
|
|
11,359
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|
|
|
|
|
|
|
|
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Operating costs and expenses:
|
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|
|
|
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|
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Cost of goods sold
|
|
435
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|
|
|
1,623
|
|
|
|
590
|
|
|
|
2,148
|
|
|
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Research and development
|
|
2,850
|
|
|
|
3,237
|
|
|
|
5,668
|
|
|
|
5,223
|
|
|
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General and administrative
|
|
3,940
|
|
|
|
3,855
|
|
|
|
7,442
|
|
|
|
7,299
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Lease exit and termination costs
|
|
247
|
|
|
|
(16
|
)
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|
|
173
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|
|
(168
|
)
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Total operating costs and expenses
|
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7,472
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|
|
|
8,699
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|
|
|
13,873
|
|
|
|
14,502
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Amortization of deferred gain on sale leaseback
|
|
-
|
|
|
|
426
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|
|
|
-
|
|
|
|
851
|
|
|
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Loss from operations
|
|
(1,730
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)
|
|
|
(810
|
)
|
|
|
(2,495
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)
|
|
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(2,292
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)
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Other income (expense), net
|
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(1,998
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)
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|
|
37
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(1,755
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)
|
|
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(2,038
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)
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Income tax (expense) benefit
|
|
(338
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)
|
|
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(141
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)
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(303
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)
|
|
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13,444
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Income (loss) from continuing operations
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(4,066
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)
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(914
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)
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|
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(4,553
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)
|
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|
9,114
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Income from discontinued operations, net of taxes
|
|
1,799
|
|
|
|
-
|
|
|
|
3,670
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|
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|
4
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Net income
|
$
|
(2,267
|
)
|
|
$
|
(914
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)
|
|
$
|
(883
|
)
|
|
$
|
9,118
|
|
|
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Basic and diluted per share amounts:
|
|
|
|
|
|
|
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Income (loss) from continuing operations
|
$
|
(0.20
|
)
|
|
$
|
(0.05
|
)
|
|
$
|
(0.23
|
)
|
|
$
|
0.46
|
|
|
|
Discontinued operations
|
|
0.09
|
|
|
|
-
|
|
|
|
0.19
|
|
|
|
0.00
|
|
|
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Net income
|
$
|
(0.11
|
)
|
|
$
|
(0.05
|
)
|
|
$
|
(0.04
|
)
|
|
$
|
0.46
|
|
|
|
|
|
|
|
|
|
|
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Weighted average number of common shares
|
|
19,749,266
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|
|
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19,650,260
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|
|
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19,728,852
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19,623,249
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|
|
|
|
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LIGAND PHARMACEUTICALS INCORPORATED CONDENSED
CONSOLIDATED BALANCE SHEETS (in thousands)
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|
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June 30, 2012
|
|
December 31, 2011
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Assets
|
(unaudited)
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Current assets:
|
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Cash, cash equivalents and short-term investments
|
$ 10,385
|
|
$ 17,041
|
|
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Accounts receivable
|
817
|
|
6,110
|
|
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Inventory
|
2,698
|
|
1,301
|
|
|
Other current assets
|
2,262
|
|
1,581
|
|
|
Current portion of co-promote termination asset
|
4,934
|
|
6,197
|
|
|
Total current assets
|
21,096
|
|
32,230
|
|
|
|
|
|
|
|
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Restricted cash and investments
|
1,341
|
|
1,341
|
|
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Property and equipment, net
|
644
|
|
455
|
|
|
Goodwill and other identifiable intangible assets
|
71,167
|
|
72,331
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|
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Long-term portion of co-promote termination asset
|
9,822
|
|
15,255
|
|
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Other assets
|
524
|
|
738
|
|
|
Total Assets
|
$ 104,594
|
|
$ 122,350
|
|
|
|
|
|
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|
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Liabilities and Stockholders' Equity
|
|
|
|
|
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Accounts payable and accrued liabilities
|
18,179
|
|
$ 27,446
|
|
|
Current portion of co-promote termination liability
|
4,934
|
|
6,197
|
|
|
Current portion of note payable
|
5,806
|
|
-
|
|
|
Bank line of credit
|
1,500
|
|
10,000
|
|
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Total current liabilities
|
30,419
|
|
43,643
|
|
|
Long-term portion of co-promote termination liability
|
9,822
|
|
15,255
|
|
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Long-term portion of deferred revenue
|
2,722
|
|
3,466
|
|
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Long-term debt
|
22,211
|
|
20,286
|
|
|
Other long-term liabilities
|
20,968
|
|
22,710
|
|
|
Total liabilities
|
86,142
|
|
105,360
|
|
|
Common stock subject to conditional redemption
|
-
|
|
8,344
|
|
|
Stockholders' equity
|
18,452
|
|
8,646
|
|
|
Total liabilities and stockholders' deficit
|
$ 104,594
|
|
$ 122,350
|
|
|
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Source: Ligand Pharmaceuticals