Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) today announced
financial results for the three and six months ended June 30, 2011 and
provided an update on key programs.
"We are very pleased with the significant developments at Ligand over
the past few months and are building strong operating and financial
momentum as we move into the second half of 2011,” said John Higgins,
President and Chief Executive Officer of Ligand. "Our premier partner
GlaxoSmithKline (GSK) recently announced positive Phase III results for
one of their pivotal trials for Promacta® in patients with
hepatitis C. In addition to recent bullish remarks from GSK’s CEO about
this program, we are also pleased to see a significant 47% increase in
second quarter sales of Promacta as compared to the first quarter.”
Higgins continued, "In addition, during the past quarter we announced
positive data for our SARM and melphalan programs, and we expanded our
Captisol® business by entering into new agreements with Merck
and The Medicines Company. Finally, we had a very solid quarter
financially and are moving into a period of significant news flow
expected for numerous Phase II and Phase III partnered assets over the
next few quarters.”
Second Quarter Results
Total revenues for the three months ended June 30, 2011 were $7.5
million, compared with $5.8 million for the same period in 2010. The
increase in revenue was due primarily to material sales of Captisol,
higher royalties and recognition of non-cash deferred revenue relating
to Fablyn.
Cost of goods sold was $1.6 million for the second quarter of 2011.
Other operating costs and expenses from continuing operations in the
second quarter of 2011 were $7.1 million, compared with $9.9 million in
the second quarter of 2010. Research and development expenses declined
by $3.4 million, primarily due to the termination of research funding
under the Company’s remaining collaboration agreements and the closing
of its New Jersey facility. General and administrative expenses
increased by $0.6 million, primarily due to increases in stock-based
compensation and legal expenses.
The net loss in the second quarter of 2011 was $0.9 million, or $0.05
per share, compared with a net loss of $0.3 million, or $0.01 per share,
in the comparable 2010 quarter. The loss from continuing operations in
the second quarter of 2011 was $0.9 million, or $0.05 per share,
compared with a loss from continuing operations of $0.3 million, or
$0.01 per share, in the comparable 2010 quarter.
As of June 30, 2011, Ligand had cash, cash equivalents, short-term
investments and restricted investments of $14.8 million.
Year-to-Date Results
Total revenues for the six months ended June 30, 2011 were $11.4
million, compared with $11.8 million for the first six months of 2010.
Cost of goods sold was $2.1 million for the first six months of 2011.
Other operating costs and expenses for the first six months of 2011 were
$13.1 million, compared with $20.3 million for the first six months of
2010.
Net income for the first six months of 2011 was $8.6 million, or $0.44
per diluted share, compared with a net loss of $3.0 million, or $0.15
per share, for the first six months of 2010. Income from continuing
operations for the first half of 2011 was $8.6 million, or $0.44 per
diluted share, compared with a loss from continuing operations of $3.0
million, or $0.15 per share, in the comparable 2010 period. Net income
and income from continuing operations for the first half of 2011 include
a $13.6 million income tax benefit.
Join Ligand on Twitter @Ligand_LGND
-
Ligand launched its own Twitter feed and has been posting tweets on
partnership news, links to content published on various Ligand-related
topics and upcoming Ligand events. To become a follower on the Ligand
Twitter feed visit http://www.twitter.com/Ligand_LGND
or contact Erika Luib at (858) 550-7896 or via e-mail at eluib@ligand.com.
Second Quarter and Recent Partner Highlights
-
Ligand partner GlaxoSmithKline announced that it received positive
data from ENABLE-1, the first of two Phase III studies examining
Promacta (eltrombopag) in patients with hepatitis C-related
thrombocytopenia, and that full data will be released at an upcoming
scientific conference.
-
Ligand licensed exclusive worldwide rights to The Medicines Company
for Ligand’s Captisol-enabled® intravenous formulation of
clopidogrel, the active ingredient in the world’s leading antiplatelet
medicine.
-
Ligand partner Baxter International Inc. launched Nexterone®
(amiodarone HCl), Premixed Injection, the first and only ready-to-use
premixed intravenous (IV) bag version of the antiarrhythmic agent
amiodarone in the United States.
-
Ligand partner Onyx Pharmaceuticals presented several studies
evaluating carfilzomib, a selective, next-generation proteasome
inhibitor, at the 16th Congress of the European Hematology Association
(EHA) Annual Meeting in London.
-
Ligand presented a poster of its Phase I multi-dose program on
LGD-4033, a selective androgen receptor modulator (SARM), at the
Endocrine Society Annual Meeting in Boston.
-
Ligand presented interim data from a Phase IIa study with its
Captisol-enabled, propylene glycol-free melphalan program in a poster
presentation at the 2011 American Society of Clinical Oncology (ASCO)
Annual Meeting in Chicago.
-
Ligand entered into a Captisol supply agreement with Merck & Co., Inc.
for an undisclosed program where Ligand will supply clinical and
commercial supplies of Captisol.
-
Ligand announced its strategic decision to internally advance
development of its Captisol-enabled melphalan program with the current
goal to file a New Drug Application (NDA) with the U.S. Food and Drug
Administration (FDA) by mid-2013 if the development is successful.
-
Ligand ranked as one of the top 50 industry innovators by The
Pharmaceuticals Patent Scorecard. The Pharmaceutical Industry
Scorecard is published three times a year on The Wall Street Journal’s
Web site and links a company’s patents to its innovation, technology,
and science strengths.
Operating Forecast and Financial Outlook
Affirming its previous forecast, Ligand expects 2011 total revenues to
be between approximately $22 million and $24 million. Ligand's 2011
operating expenses are now estimated to be between approximately $23
million and $24 million, including approximately $2 million of non-cash
amortization of intangible assets as a result of the CyDex acquisition.
This compares with the previous guidance for operating expenses to be
about $20 million. The increase in operating expenses from previous
guidance is primarily due to increases in stock-based compensation and
patent and legal costs. In addition, Ligand expects an average gross
margin on material sales of approximately 60%. By the end of 2011,
Ligand expects its operations to be profitable and cash-flow positive.
Upcoming Events
Ligand is scheduled to present at the following investment conferences:
-
Stifel Nicolaus 2011 Healthcare Conference, Boston, September 9 at
10:20 a.m. Eastern time (7:20 a.m. Pacific time).
-
Oppenheimer 22nd Annual Healthcare Conference, New York,
December 13-14, presentation date and time to be determined.
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, 2011 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 376512. 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 of
developing or acquiring royalty revenue-generating assets and
technologies and coupling them to a lean corporate cost structure with
the goal of producing sustained profitability. By diversifying the
portfolio of assets across numerous technology types, therapeutic areas,
drug targets and industry partners, we offer an opportunity to invest in
the increasingly complicated and unpredictable pharmaceutical industry.
In comparison to our industry peers, we believe Ligand has assembled one
of the largest and most diversified asset portfolios in the industry
with significant revenue-generating potential. These therapies address
the unmet medical needs of patients for a broad spectrum of diseases
including hepatitis C, muscle wasting, Alzheimer's disease,
dyslipidemia, diabetes, anemia, COPD, asthma, rheumatoid arthritis and
osteoporosis. Ligand has established alliances with several of the
world's leading pharmaceutical companies including GlaxoSmithKline, The
Medicines Company, Pfizer, Bristol-Myers Squibb, Merck and AstraZeneca.
For more information, 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 2011, 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 2011 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
2011 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)
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
|
|
2011
|
|
|
|
2010
|
|
|
|
2011
|
|
|
|
2010
|
|
|
Revenues:
|
|
|
|
|
|
|
Royalties
|
$
|
2,172
|
|
|
$
|
1,601
|
|
|
$
|
4,165
|
|
|
$
|
3,563
|
|
|
Material sales
|
|
2,984
|
|
|
|
0
|
|
|
|
4,034
|
|
|
|
0
|
|
|
Collaborative research and development
and other revenues
|
|
2,307
|
|
|
|
4,237
|
|
|
|
3,160
|
|
|
|
8,233
|
|
|
Total revenues
|
|
7,463
|
|
|
|
5,838
|
|
|
|
11,359
|
|
|
|
11,796
|
|
|
Operating costs and expenses:
|
|
|
|
|
|
|
|
|
Cost of goods sold
|
|
1,623
|
|
|
|
0
|
|
|
|
2,148
|
|
|
|
0
|
|
|
Research and development
|
|
3,237
|
|
|
|
6,602
|
|
|
|
5,223
|
|
|
|
13,963
|
|
|
General and administrative
|
|
3,855
|
|
|
|
3,290
|
|
|
|
8,034
|
|
|
|
6,338
|
|
|
Lease exit and termination costs
|
|
(16
|
)
|
|
|
0
|
|
|
|
(168
|
)
|
|
|
0
|
|
|
Total operating costs and expenses
|
|
8,699
|
|
|
|
9,892
|
|
|
|
15,237
|
|
|
|
20,301
|
|
|
Amortization of deferred gain on sale leaseback
|
|
426
|
|
|
|
426
|
|
|
|
851
|
|
|
|
851
|
|
|
Loss from operations
|
|
(810
|
)
|
|
|
(3,628
|
)
|
|
|
(3,027
|
)
|
|
|
(7,654
|
)
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net
|
|
37
|
|
|
|
3,963
|
|
|
|
(2,038
|
)
|
|
|
5,273
|
|
|
Income tax benefit (expense)
|
|
(141
|
)
|
|
|
(625
|
)
|
|
|
13,637
|
|
|
|
(899
|
)
|
|
Loss from continuing operations
|
|
(914
|
)
|
|
|
(290
|
)
|
|
|
8,572
|
|
|
|
(3,280
|
)
|
|
Discontinued operations, net of taxes
|
|
—
|
|
|
|
7
|
|
|
|
4
|
|
|
|
246
|
|
|
Net loss
|
$
|
(914
|
)
|
|
$
|
(283
|
)
|
|
$
|
8,576
|
|
|
$
|
(3,034
|
)
|
|
Basic and diluted per share amounts:
|
|
|
|
|
|
|
|
|
Loss from continuing operations
|
$
|
(0.05
|
)
|
|
$
|
(0.01
|
)
|
|
$
|
0.44
|
|
|
$
|
(0.16
|
)
|
|
Discontinued operations
|
|
0.00
|
|
|
|
0.00
|
|
|
|
0.00
|
|
|
|
0.01
|
|
|
Net income (loss)
|
$
|
(0.05
|
)
|
|
$
|
(0.01
|
)
|
|
$
|
0.44
|
|
|
$
|
(0.15
|
)
|
|
Weighted average number of common
Shares - basic
|
|
19,650,260
|
|
|
|
19,608,685
|
|
|
|
19,623,249
|
|
|
|
19,595,784
|
|
|
Weighted average number of common
Shares - diluted
|
|
19,650,260
|
|
|
|
19,608,685
|
|
|
|
19,637,983
|
|
|
|
19,595,784
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIGAND PHARMACEUTICALS INCORPORATED
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
|
|
|
|
|
|
|
|
June 30, 2011
|
|
December 31, 2010
|
|
Assets
|
(unaudited)
|
|
|
|
Current assets:
|
|
|
|
|
Cash, cash equivalents and short-term investments
|
$
|
13,441
|
|
$
|
22,697
|
|
|
Accounts receivable, net
|
|
1,038
|
|
|
993
|
|
|
Inventory
|
|
2,594
|
|
|
—
|
|
|
Other current assets
|
|
3,037
|
|
|
5,295
|
|
|
Current portion of co-promote termination asset
|
|
8,029
|
|
|
8,034
|
|
|
Total current assets
|
|
28,139
|
|
|
37,019
|
|
|
|
|
|
|
|
Restricted cash and investments
|
|
1,341
|
|
|
1,341
|
|
|
Property and equipment, net
|
|
679
|
|
|
559
|
|
|
Goodwill and other identifiable intangible assets
|
|
75,157
|
|
|
12,951
|
|
|
Long-term portion of co-promote termination asset
|
|
21,346
|
|
|
22,851
|
|
|
Other assets
|
|
773
|
|
|
838
|
|
|
|
$
|
127,435
|
|
$
|
75,559
|
|
|
|
|
|
|
|
Liabilities and Stockholders' Equity
|
|
|
|
|
Accounts payable and accrued liabilities
|
$
|
23,435
|
|
$
|
24,177
|
|
|
Current portion of deferred gain
|
|
851
|
|
|
1,277
|
|
|
Current portion of co-promote termination liability
|
|
8,029
|
|
|
8,034
|
|
|
Bank line of credit
|
|
10,000
|
|
|
—
|
|
|
Total current liabilities
|
|
42,315
|
|
|
33,488
|
|
|
Long-term portion of co-promote termination liability
|
|
21,346
|
|
|
22,851
|
|
|
Long-term portion of deferred revenue
|
|
1,291
|
|
|
2,546
|
|
|
Long-term debt
|
|
20,114
|
|
|
—
|
|
|
Other long-term liabilities
|
|
28,698
|
|
|
13,179
|
|
|
Total liabilities
|
|
113,764
|
|
|
72,064
|
|
|
Common stock subject to conditional redemption
|
|
8,344
|
|
|
8,344
|
|
|
Stockholders' equity
|
|
5,327
|
|
|
(4,849
|
)
|
|
|
$
|
127,435
|
|
$
|
75,559
|
|
|
|
|
|
|
|
|
|
