Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today reported
financial results for the three and 12 months ended December 31, 2011,
and reviewed business highlights of the fourth quarter of 2011 and early
2012.
"Ligand had a fantastic 2011 closing a series of important deals and
realizing profits and positive cash-flow from operations. We have
significant momentum as we move into 2012,” said John Higgins, President
and Chief Executive Officer of Ligand Pharmaceuticals. "Over the
past few years Ligand has implemented an ambitious business development
strategy, and our success has dramatically expanded our portfolio of
partnered assets. We have a robust calendar of late-stage regulatory
developments for 2012, including anticipated NDA submissions for
Promacta for HCV, the FDA’s decision on Carfilzomib and a projected NDA
filing for Aprela. 2012 looks very promising.”
Fourth Quarter Results
Total revenues from continuing operations for the fourth quarter of 2011
were $12.9 million, compared with $3.9 million for the fourth quarter of
2010. The $9.0 million increase is primarily due to material sales of
Captisol®, higher royalties and an increase in one-time license and
milestone revenues.
Cost of goods sold was $2.1 million for the fourth quarter of 2011.
Other operating costs and expenses from continuing operations for the
fourth quarter of 2011 were $6.5 million; this compares with operating
costs and expenses of $10.3 million for the fourth quarter of 2010
including a $2.8 million write-off of in-process research and
development for a discontinued program. Research and development
expenses were $2.6 million, a decline of $0.6 million compared with the
fourth quarter of 2010, primarily due to lower spending related to
internal research programs. General and administrative expenses were
$3.7 million, an increase of $0.2 million compared with the fourth
quarter of 2010.
Net income for the fourth quarter of 2011 was $4.8 million, or $0.24 per
share, compared with net income for the fourth quarter of 2010 of $4.5
million, or $0.23 per share. Income from continuing operations for the
fourth quarter of 2011 was $4.8 million, or $0.24 per share, compared
with income from continuing operations for the fourth quarter of 2010 of
$2.3 million, or $0.12 per share.
As of December 31, 2011, Ligand had cash, cash equivalents, short-term
investments and restricted investments of $18.4 million and accounts
receivable of $6.1 million.
Full-Year Results
Total revenues for 2011 were $30.0 million, compared with $23.5 million
for 2010. Cost of goods sold was $4.9 million for 2011. Other operating
costs and expenses for 2011 were $27.5 million, including a $2.3 million
write-off of in-process research and development for discontinued
programs; this compares with operating costs and expenses for 2010 of
$54.5 million, including $16.9 million of lease exit and termination
costs and a $2.8 million write-off of in-process research and
development for a discontinued program.
Net income for 2011 was $10.2 million, or $0.52 per share, compared with
a net loss for 2010 of $10.4 million, or $0.53 per share. Net income for
2011 includes a $13.1 million income tax benefit.
Selected Business and Program Highlights
The following is a summary of business and key program highlights in the
fourth quarter of 2011 and early 2012.
Corporate Highlights
-
Ligand Names Nishan de Silva, M.D. Vice President of Corporate
Development.
Partnering Highlights
-
Ligand entered into platform Captisol License and Supply Agreements
with Eli Lilly and Company.
-
Ligand entered into a Captisol License and Supply Agreement with
Hospira Inc.
-
Ligand entered into a platform Captisol License Agreement with SAGE
Therapeutics for the development of central nervous system
therapeutics.
-
Pfizer announced plans to submit NDA for Aprela (bazedoxifene +
PREMARIN®) in 2012.
-
Rib-X Pharmaceuticals completed Phase II trials with Captisol-enabled®
Delafloxacin, a novel, broad spectrum fluoroquinolone for the
treatment of resistant Gram-positive infections, including MRSA, as
well as Gram-negative infections and anaerobic infections. Rib-X plans
to initiate a Phase III in the second half of 2012.
-
Onyx Pharmaceuticals announced it expects an FDA decision on
Captisol-enabled Carfilzomib, a selective next-generation proteasome
inhibitor for the treatment for multiple myeloma in 2012.
-
The Medicines Company announced plans to initiate a pivotal trial in
2012 for MDCO-157 Captisol-enabled Clopidogrel IV and to submit an NDA
in 2013.
-
Ligand entered into a Global Licensing Agreement with Chiva
Pharmaceuticals for Fablyn® for the treatment of osteoporosis.
Development Highlights
-
Ligand announced successful Phase II results for Captisol-enabled
Propylene Glycol-Free Melphalan at the 2012 BMT Tandem Meetings
Conference.
-
Ligand announced data from preclinical studies with LG7455, a
granulocyte colony stimulating factor (GCSF) receptor program featured
in a poster presentation at the 53rd Annual Meeting of the
American Society of Hematology.
-
Ligand announced positive preclinical data on its IRAK4 Program at the
2011 American College of Rheumatology Annual Scientific Meeting.
2012 Financial Outlook
For 2012, Ligand currently estimates total revenues to be approximately
$30 million. Approximately half of 2012 revenue is forecasted to be
derived from royalties, one-quarter from material sales and one-quarter
from licensing payments. Combined research and development and general
and administrative expenses are projected to be approximately $25
million. Included in this expense guidance is approximately $6 million
of non-cash expense items.
Upcoming Conferences
Ligand is scheduled to present at the following conferences in the first
half of 2012:
-
BIO CEO Conference, February 13 at 8:30 a.m. ET, New York
-
Citi 2012 Global Health Care Conference, February 28 at 3:00 p.m. ET,
New York
-
Roth Capital 24th Annual OC Growth Stock Conference, March
11-14, Dana Point, California
-
2012 BofA Merrill Lynch Healthcare Conference, May 15-17, Las Vegas
-
Jefferies 2012 Global Healthcare Conference, June 4-7, New York
Webcast and 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 7, 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 387061. 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. We
believe Ligand has assembled one of the largest and most diversified
asset portfolios in the industry with future revenue-generating
potential. These therapies address the unmet medical needs of patients
for a broad spectrum of diseases including hepatitis, muscle wasting,
dyslipidemia, diabetes, anemia, asthma, rheumatoid arthritis 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 able to effectively
integrate CyDex’s business into our current business, expected royalties
on partnered products or from research and development milestones, and
we and our partners may not be able to timely or successfully advance
any product(s) in Ligand's internal and partnered pipeline. In addition,
there can be no assurance that Ligand will achieve its guidance for
2012, that Ligand will deliver strong cash flow over the long term, that
Ligand's 2012 revenues will be driven by royalty payments related and
Captisol sales, 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 and may be subject to
future tax liabilities which are larger than the provision for income
taxes reflected in Ligand’s 2011 year-end financial statements. 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]
|
LIGAND PHARMACEUTICALS INCORPORATED
|
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
(unaudited)
|
|
(in thousands, except share data)
|
|
|
|
|
|
Three Months Ended December 31,
|
|
Twelve Months Ended December 31,
|
|
|
|
|
2011
|
|
|
|
2010
|
|
|
|
2011
|
|
|
|
2010
|
|
|
Revenues:
|
|
|
|
|
|
|
|
Royalties
|
|
$
|
2,616
|
|
|
$
|
1,942
|
|
|
$
|
9,213
|
|
|
$
|
7,279
|
|
|
Material sales
|
|
|
6,460
|
|
|
|
—
|
|
|
|
12,123
|
|
|
|
—
|
|
|
Collaborative research and development and other revenues
|
|
|
3,861
|
|
|
|
1,998
|
|
|
|
8,701
|
|
|
|
16,259
|
|
|
Total revenues
|
|
|
12,937
|
|
|
|
3,940
|
|
|
|
30,037
|
|
|
|
23,538
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating costs and expenses:
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
|
|
|
2,059
|
|
|
|
—
|
|
|
|
4,909
|
|
|
|
—
|
|
|
Research and development
|
|
|
2,599
|
|
|
|
3,155
|
|
|
|
10,291
|
|
|
|
22,067
|
|
|
General and administrative
|
|
|
3,709
|
|
|
|
3,465
|
|
|
|
14,977
|
|
|
|
12,829
|
|
|
Write-off of in process R&D
|
|
|
—
|
|
|
|
2,754
|
|
|
|
2,282
|
|
|
|
2,754
|
|
|
Lease exit and termination costs
|
|
|
147
|
|
|
|
954
|
|
|
|
(22
|
)
|
|
|
16,894
|
|
|
Total operating costs and expenses
|
|
|
8,514
|
|
|
|
10,328
|
|
|
|
32,437
|
|
|
|
54,544
|
|
|
Amortization of deferred gain on sale leaseback
|
|
|
426
|
|
|
|
426
|
|
|
|
1,702
|
|
|
|
1,702
|
|
|
Gain (loss) from operations
|
|
|
4,849
|
|
|
|
(5,962
|
)
|
|
|
(698
|
)
|
|
|
(29,304
|
)
|
|
Other income (expense), net
|
|
|
272
|
|
|
|
4,374
|
|
|
|
(2,232
|
)
|
|
|
13,901
|
|
|
Income tax benefit (expense)
|
|
|
(311
|
)
|
|
|
3,936
|
|
|
|
13,103
|
|
|
|
2,617
|
|
|
Income (loss) from continuing operations
|
|
|
4,810
|
|
|
|
2,348
|
|
|
|
10,173
|
|
|
|
(12,786
|
)
|
|
Discontinued operations, net of taxes
|
|
|
—
|
|
|
|
2,155
|
|
|
|
3
|
|
|
|
2,413
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
$
|
4,810
|
|
|
$
|
4,503
|
|
|
$
|
10,176
|
|
|
$
|
(10,373
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted per share amounts:
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing operations
|
|
$
|
0.24
|
|
|
$
|
0.12
|
|
|
$
|
0.52
|
|
|
$
|
(0.65
|
)
|
|
Discontinued operations
|
|
|
0.00
|
|
|
|
0.11
|
|
|
|
0.00
|
|
|
|
0.12
|
|
|
Net income (loss)
|
|
$
|
0.24
|
|
|
$
|
0.23
|
|
|
$
|
0.52
|
|
|
$
|
(0.53
|
)
|
|
Weighted average number of common Shares – basic
|
|
|
19,674,945
|
|
|
|
19,630,764
|
|
|
|
19,655,632
|
|
|
|
19,613,201
|
|
|
Weighted average number of common Shares – diluted
|
|
|
19,738,228
|
|
|
|
19,636,359
|
|
|
|
19,713,320
|
|
|
|
19,613,201
|
|
|
|
|
LIGAND PHARMACEUTICALS INCORPORATED
|
|
CONDENSED CONSOLIDATED BALANCE SHEETS
|
|
(in thousands)
|
|
|
|
|
|
December 31, 2011
|
|
December 31, 2010
|
|
Assets
|
|
(unaudited)
|
|
|
|
Current assets:
|
|
|
|
|
|
Cash, cash equivalents and short-term investments
|
|
$
|
17,041
|
|
$
|
22,697
|
|
|
Accounts receivable, net
|
|
|
6,110
|
|
|
993
|
|
|
Inventory
|
|
|
1,301
|
|
|
—
|
|
|
Other current assets
|
|
|
1,581
|
|
|
5,295
|
|
|
Current portion of co-promote termination asset
|
|
|
6,197
|
|
|
8,034
|
|
|
Total current assets
|
|
|
32,230
|
|
|
37,019
|
|
|
|
|
|
|
|
|
Restricted cash and investments
|
|
|
1,341
|
|
|
1,341
|
|
|
Property and equipment, net
|
|
|
455
|
|
|
559
|
|
|
Goodwill and other identifiable intangible assets
|
|
|
72,331
|
|
|
12,951
|
|
|
Long-term portion of co-promote termination asset
|
|
|
15,255
|
|
|
22,851
|
|
|
Other assets
|
|
|
738
|
|
|
838
|
|
|
|
|
$
|
122,350
|
|
$
|
75,559
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders' Equity
|
|
|
|
|
|
Accounts payable and accrued liabilities
|
|
$
|
27,446
|
|
$
|
24,177
|
|
|
Current portion of deferred gain
|
|
|
—
|
|
|
1,277
|
|
|
Current portion of co-promote termination liability
|
|
|
6,197
|
|
|
8,034
|
|
|
Bank line of credit
|
|
|
10,000
|
|
|
—
|
|
|
Total current liabilities
|
|
|
43,643
|
|
|
33,488
|
|
|
Long-term portion of co-promote termination liability
|
|
|
15,255
|
|
|
22,851
|
|
|
Long-term portion of deferred revenue
|
|
|
3,466
|
|
|
2,546
|
|
|
Long-term debt
|
|
|
20,286
|
|
|
—
|
|
|
Other long-term liabilities
|
|
|
22,710
|
|
|
13,179
|
|
|
Total liabilities
|
|
|
105,360
|
|
|
72,064
|
|
|
Common stock subject to conditional redemption
|
|
|
8,344
|
|
|
8,344
|
|
|
Stockholders' equity
|
|
|
8,646
|
|
|
(4,849
|
)
|
|
|
|
$
|
122,350
|
|
$
|
75,559
|
|
