Conference call begins at 4:30 p.m. Eastern time today
Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) (the “Company”
or “Ligand”) today
announced financial results for the three and nine months ended
September 30, 2008 and provided a business update.
Third Quarter Results
Total revenues for the third quarter of 2008 were $5.2 million, compared
with $5.5 million for the third quarter of 2007, which included $0.3
million of milestone revenues.
Operating costs and expenses for the third quarter of 2008 were $12.1
million, compared with $14.7 million for the third quarter of 2007. The
decrease is primarily due to lower headcount related expenses as a
result of our restructuring in the fourth quarter of 2007 and outside
service costs associated with our TPO program, partially offset by
higher legal costs.
The loss from continuing operations for the third quarter of 2008 was
$9.1 million, or $0.10 per share, compared with a loss from continuing
operations of $4.9 million, or $0.05 per share, for the third quarter of
2007. Loss from discontinued operations in the third quarter of 2008 was
$9.0 million, or $0.09 per share, compared with income from discontinued
operations of $6.1 million, or $0.06 per share, in the third quarter of
2007. The loss from discontinued operations for the third quarter of
2008 includes $13.0 million related to the Salk settlement discussed
below, partially offset by changes to product returns and rebate
reserves.
Total net loss for the third quarter of 2008 was $18.1 million, or $0.19
per share, compared with total net income of $1.2 million, or $0.01 per
share, in the third quarter of 2007.
As of September 30, 2008, Ligand had cash, cash equivalents, short-term
investments and restricted investments of $72.5 million. In addition,
approximately $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.
“We are very excited about the pending merger
with Pharmacopeia, which we announced on September 24, 2008. This
business combination represents a unique opportunity for stockholders of
both companies, and will significantly expand our drug candidate
pipeline and drug discovery resources, and increase our potential
royalty streams from partners,” said John L.
Higgins, President and Chief Executive Officer of Ligand
Pharmaceuticals. “We also are pleased with the
progress of partnered programs, which include three drugs for which NDAs
have been filed and may receive approval in the near term. Our recent
results and strategic execution demonstrate Ligand’s
commitment to building shareholder value by advancing a broad array of
royalty assets and pipeline programs, backed by a strong balance sheet
and spending discipline.”
Year-to-Date Results
Total revenues for the nine months ended September 30, 2008 were $14.9
million, compared with $7.1 million for the nine months ended September
30, 2007. Royalty revenues for the first nine months of 2008 were $14.9
million, compared with royalty revenues of $6.6 million for the same
period in 2007.
Operating costs and expenses for the first nine months of 2008 were
$40.3 million, compared with $60.7 million for the same period in 2007.
Operating costs and expenses for the nine months ended September 30,
2008 include $4.3 million of one-time charges related to exit costs as a
result of a facility vacated in the first quarter of 2008. Operating
costs and expenses for the nine months ended September 30, 2007 include
$11.6 million of one-time charges related to severance benefits and
stock compensation expenses associated with a restructuring and an
equitable adjustment of stock options. Excluding these one-time charges,
the decrease in operating costs and expenses was primarily due to lower
headcount related expenses, reduced consulting and occupancy costs and
reduced research costs associated with our TPO program, partially offset
by higher legal costs.
The loss from continuing operations for the first nine months of 2008
was $23.7 million, or $0.25 per share, compared with a loss from
continuing operations of $29.4 million, or $0.30 per share, for the
first nine months of 2007. Loss from discontinued operations for the
first nine months of 2008 was $4.8 million, or $0.05 per share, compared
with income from discontinued operations of $305.2 million, or $3.08 per
share, for the first nine months of 2007.
Total net loss for the nine months ended September 30, 2008 was $28.5
million, or $0.30 per share, compared with total net income of $275.8
million, or $2.78 per share, for the same period in 2007.
Third Quarter Highlights
-
In September 2008, Ligand entered into a definitive merger agreement
to acquire Pharmacopeia (NASDAQ: PCOP). Pharmacopeia is a
Princeton-based biotech company that has a strong combinatorial
chemistry discovery platform and numerous valuable partnerships with
large pharmaceutical companies. Subject to SEC review and a
Pharmacopeia shareholder vote, the deal is expected to close by
January 2009.
-
In September 2008, Ligand and The Salk Institute for Biological
Studies (“SALK”)
entered into a Settlement Agreement and Mutual Release of All Claims (“Settlement
Agreement”). Under the Settlement
Agreement, the parties have resolved all disputes that have arisen
between them including SALK's primary claim in arbitration relating to
the sale of Targretin® to Eisai Inc. in
2006. In addition, the parties have dismissed with prejudice all of
the claims and counterclaims asserted in the arbitration between the
parties.
-
In July 2008, Stephen L. Sabba, M.D. joined Ligand’s
Board of Directors. Dr. Sabba is an analyst and fund manager at the
investment firm Knott Partners Management, and was previously a
partner and director of research at Kilkenny Capital Management.
Earlier, he was a gastroenterologist and internist in private practice
at Phelps Memorial Hospital in Tarrytown, New York.
Key Program Updates
LGD-4665 –
TPO Mimetic: Ligand has completed several Phase I
pharmacology studies to further define drug activity in healthy
volunteers. Ligand is currently conducting a Phase II trial in ITP. The
24 patient, double-blind placebo-controlled trial is designed to
evaluate the safety and efficacy of LGD-4665 in adult patients with
idiopathic thrombocytopenic purpura (ITP) over six weeks of treatment.
Ligand intends to present data from its Phase I studies at the American
Society of Hematology Conference in December 2008, as well as announce
preliminary, interim information from our ongoing Phase II ITP trial.
GlaxoSmithKline –
TPO Mimetic, Eltrombopag: On September 19, 2008 Ligand’s
partner GlaxoSmithKline announced that the U.S. Food and Drug
Administration (“FDA”)
continues to review the New Drug Application (“NDA”)
for PROMACTA® (eltrombopag) beyond the
September 19 action date. PROMACTA is intended for the treatment of
patients with chronic immune (idiopathic) thrombocytopenic purpura (“ITP”),
and if approved, it will be the first oral thrombopoietin (“TPO”)
receptor agonist therapy for the treatment of adult patients with
chronic ITP. GSK also expects MAA and NDA submissions for the long-term
treatment of ITP by year-end.
Pfizer –
SERM, Lasofoxifene: The FDA has extended the review period
for Pfizer’s NDA for FABLYN®
(lasofoxifene) for the treatment of osteoporosis in postmenopausal
women. The original PDUFA date of October 2008 has been extended to
January 2009. On September 8, 2008 an FDA advisory committee recommended
with a 9-3 vote that there is a population of postmenopausal women with
osteoporosis in which the benefit of treatment with lasofoxifene is
likely to outweigh the risks.
Wyeth –
SERM (selective estrogen receptor modulator), Bazedoxifene:
VIVIANT™ (bazedoxifene): In May 2008, Wyeth
received an approvable letter from the FDA with respect to the NDA for
the treatment of postmenopausal osteoporosis. In its letter, the FDA
requested information similar to that outlined in its December 2007
approvable letter for the NDA for the prevention of postmenopausal
osteoporosis. Wyeth expects that an FDA Advisory Committee meeting will
be scheduled following submission of its complete response to the
approvable letters with respect to the prevention and treatment
indications, which Wyeth plans to file in the first half of 2009.
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 and Wyeth expects to
file an initial NDA no earlier than the second half of 2009.
LGD-4033 –
SARM (Selective Androgen Receptor Modulator): Ligand
continues to conduct preclinical work on its lead SARM candidate,
LGD-4033. Ligand’s SARM program is focused on
a novel class of non-steroidal, orally active molecules that selectively
modulate the activity of the androgen receptor in different tissues.
LGD-4033 is a highly selective androgen receptor full agonist in
skeletal muscle, a classic target tissue for androgen action. Ligand
expects to file an Investigational New Drug (“IND”)
application by year-end for LGD-4033.
EPO Mimetic:
Ligand continues to optimize potential lead compounds as small-molecule,
oral erythropoietin (EPO) mimetics. Ligand has made progress toward the
discovery of potent orally active EPO drugs.
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
fourth quarter of 2008, the Company anticipates total operating costs
will be between $9 and $10 million, including stock-based compensation
and $0.5 million of amortization of deferred gain on sale leaseback.
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)
356-5578 from the U.S. or (706) 679-0565 from outside the U.S. A replay
of the call will be available until December 6, 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 68990993. 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, certain
types of cancer, hormone-related diseases, osteoporosis and inflammatory
diseases. 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, Ligand may not receive expected royalties on AVINZA®
from King Pharmaceuticals or any other partnered products or from
research and development milestones. In addition, Ligand’s
partners may change their plans or timetables regarding Ligand’s
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 Ligand due to third party
intellectual property or contract restrictions and any amounts received
by Ligand may be subject to third party claims. Ligand may not be able
to timely or successfully advance any product(s) in our pipeline, for
example, LGD-4665 and LGD-4033. In addition, Ligand may have
indemnification obligations to King Pharmaceuticals in connection with
the sale of AVINZA. Further, Ligand may not be able to successfully or
timely complete its early stage programs or any specific business or
research initiative(s). In addition, Ligand may not be able to
successfully implement its strategy, and continue the development of
Ligand’s proprietary programs. Ligand may
also be unable to successfully integrate the combined businesses
following the consummation of the pending merger with Pharmacopeia. The
anticipated synergies and benefits from the transaction may not be fully
realized or may take longer to realize than expected. Ligand or
Pharmacopeia may not have the ability to satisfy the conditions of the
merger, or the merger may be otherwise delayed and/or ultimately not
consummated. There can be no assurance that any product in Ligand’s,
Pharmacopeia’s or the projected combined
company’s product pipeline will be
successfully developed or manufactured, that final results of clinical
studies will be supportive of regulatory approvals required to market
licensed products, or that any of the forward-looking information
provided herein will be proven accurate. 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,
www.nasdaq.com
as well as in Ligand’s public periodic
filings with the Securities and Exchange Commission at www.sec.gov
including Ligand’s recent filings on Forms
10-K and form 10-Q, or in information disclosed in public conference
calls, the date and time of which are released beforehand. 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.
Additional Information and Where to Find It
On October 20, 2008, Ligand filed with the SEC a Registration Statement
on Form S-4, which included a proxy statement of Pharmacopeia and other
relevant materials in connection with the proposed transaction. The
proxy statement will be mailed to the stockholders of Pharmacopeia.
Investors and security holders of Pharmacopeia are urged to read the
proxy statement and the other relevant materials when they become
available because they will contain important information about Ligand,
Pharmacopeia and the proposed transaction. The proxy statement and other
relevant materials (when they become available), and any other documents
filed by Ligand or Pharmacopeia with the SEC, may be obtained free of
charge at the SEC's web site at www.sec.gov.
In addition, investors and security holders may obtain free copies of
the documents filed with the SEC by Ligand (when they become available)
by going to Ligand’s Investor Relations
website at www.ligand.com.
Investors and security holders may obtain free copies of the documents
filed with the SEC by Pharmacopeia (when they become available) by going
to Pharmacopeia’s Investor Relations page on
its corporate website at www.pharmacopeia.com.
Investors and security holders of Pharmacopeia are urged to read the
proxy statement and the other relevant materials when they become
available before making any voting or investment decision with respect
to the proposed transaction.
Ligand and its respective directors and executive officers may be deemed
to be participants in the solicitation of proxies from the stockholders
of Pharmacopeia in favor of the proposed transaction. Information
concerning Ligand’s directors and executive
officers is set forth in Ligand’s proxy
statement for its 2008 annual meeting of shareholders, which was filed
with the SEC on April 29, 2008, the annual report on Form 10-K filed
with the SEC on March 5, 2008 and the current report on Form 8-K filed
with the SEC on August 4, 2008.
Pharmacopeia and its respective directors and executive officers may be
deemed to be participants in the solicitation of proxies from the
stockholders of Pharmacopeia in favor of the proposed transaction.
Information about Pharmacopeia’s executive
officers and directors and their ownership of Pharmacopeia common stock
is set forth in the proxy statement for the Pharmacopeia’s
2008 annual meeting of shareholders, which was filed with the SEC on
March 24, 2008. Investors and security holders may obtain more detailed
information regarding the direct and indirect interests of Pharmacopeia
and its respective executive officers and directors in the acquisition
by reading the proxy statement of Pharmacopeia, included as a part of
the Registration Statement on Form S-4, filed by Ligand with the SEC on
October 20, 2008.
|
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LIGAND PHARMACEUTICALS INCORPORATED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
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|
|
2008
|
|
2007
|
|
2008
|
|
2007
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
Royalties
|
|
$
|
5,248
|
|
|
$
|
5,229
|
|
|
$
|
14,926
|
|
|
$
|
6,639
|
|
|
Milestone
|
|
|
---
|
|
|
|
250
|
|
|
|
---
|
|
|
|
485
|
|
|
Total revenues
|
|
|
5,248
|
|
|
|
5,479
|
|
|
|
14,926
|
|
|
|
7,124
|
|
|
Operating costs and expenses:
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
6,165
|
|
|
|
9,838
|
|
|
|
19,707
|
|
|
|
34,191
|
|
|
General and administrative
|
|
|
5,929
|
|
|
|
4,856
|
|
|
|
20,579
|
|
|
|
26,539
|
|
|
Total operating costs and expenses
|
|
|
12,094
|
|
|
|
14,694
|
|
|
|
40,286
|
|
|
|
60,730
|
|
|
Accretion of deferred gain on sale leaseback
|
|
|
(491
|
)
|
|
|
(491
|
)
|
|
|
(1,473
|
)
|
|
|
(1,473
|
)
|
|
Loss from operations
|
|
|
(6,355
|
)
|
|
|
(8,724
|
)
|
|
|
(23,887
|
)
|
|
|
(52,133
|
)
|
|
Other income
|
|
|
221
|
|
|
|
1,502
|
|
|
|
336
|
|
|
|
6,917
|
|
|
Loss before income taxes
|
|
|
(6,134
|
)
|
|
|
(7,222
|
)
|
|
|
(23,551
|
)
|
|
|
(45,216
|
)
|
|
Income tax (expense) benefit
|
|
|
(2,990
|
)
|
|
|
2,360
|
|
|
|
(179
|
)
|
|
|
15,779
|
|
|
Loss from continuing operations
|
|
|
(9,124
|
)
|
|
|
(4,862
|
)
|
|
|
(23,730
|
)
|
|
|
(29,437
|
)
|
|
Discontinued operations:
|
|
|
|
|
|
|
|
|
|
Income from discontinued operations before income taxes
|
|
|
--
|
|
|
|
--
|
|
|
|
--
|
|
|
|
5,993
|
|
|
Gain on sale of AVINZA Product Line before income taxes
|
|
|
122
|
|
|
|
6,892
|
|
|
|
7,287
|
|
|
|
317,306
|
|
|
Gain (loss) on sale of Oncology Product Line before income taxes
|
|
|
(12,799
|
)
|
|
|
(2,138
|
)
|
|
|
(12,569
|
)
|
|
|
7,669
|
|
|
Income tax benefit (expense) on discontinued operations
|
|
|
3,676
|
|
|
|
1,356
|
|
|
|
525
|
|
|
|
(25,781
|
)
|
|
Discontinued operations
|
|
|
(9,001
|
)
|
|
|
6,110
|
|
|
|
(4,757
|
)
|
|
|
305,187
|
|
|
Net income (loss)
|
|
$
|
(18,125
|
)
|
|
$
|
1,248
|
|
|
$
|
(28,487
|
)
|
|
$
|
275,750
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted per share amounts:
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations
|
|
$
|
(0.10
|
)
|
|
$
|
(0.05
|
)
|
|
$
|
(0.25
|
)
|
|
$
|
(0.30
|
)
|
|
Discontinued operations
|
|
|
(0.09
|
)
|
|
|
0.06
|
|
|
|
(0.05
|
)
|
|
|
3.08
|
|
|
Net income (loss)
|
|
$
|
(0.19
|
)
|
|
$
|
0.01
|
|
|
$
|
(0.30
|
)
|
|
$
|
2.78
|
|
|
Weighted average number of common shares
|
|
|
95,068,102
|
|
|
|
96,541,752
|
|
|
|
95,059,166
|
|
|
|
99,020,141
|
|
|
|
|
|
|
|
|
LIGAND PHARMACEUTICALS INCORPORATED
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
|
|
|
|
|
|
|
|
|
|
September 30, 2008
|
|
December 31, 2007
|
|
Assets
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
Cash, cash equivalents and short-term investments
|
|
$
|
71,112
|
|
$
|
94,408
|
|
Other current assets
|
|
|
4,029
|
|
|
5,068
|
|
Current portion of co-promote termination payments receivable
|
|
|
10,824
|
|
|
10,467
|
|
Total current assets
|
|
|
85,965
|
|
|
109,943
|
|
|
|
|
|
|
|
Restricted investments
|
|
|
1,411
|
|
|
1,411
|
|
Property and equipment, net
|
|
|
1,687
|
|
|
2,865
|
|
Long-term portion of co-promote termination payments receivable
|
|
|
47,911
|
|
|
48,989
|
|
Restricted cash - indemnity account
|
|
|
10,217
|
|
|
10,070
|
|
Total assets
|
|
$
|
147,191
|
|
$
|
173,278
|
|
|
|
|
|
|
|
Liabilities and Stockholders' Equity
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
Accounts payable and accrued liabilities
|
|
$
|
38,197
|
|
$
|
37,009
|
|
Current portion of deferred gain
|
|
|
1,964
|
|
|
1,964
|
|
Current portion of co-promote termination liability
|
|
|
10,824
|
|
|
10,467
|
|
Note payable
|
|
|
716
|
|
|
1,528
|
|
Total current liabilities
|
|
|
51,701
|
|
|
50,968
|
|
|
|
|
|
|
|
Long-term portion of co-promote termination liability
|
|
|
47,911
|
|
|
48,989
|
|
Long-term portion of deferred gain
|
|
|
23,783
|
|
|
25,256
|
|
Other long-term liabilities
|
|
|
9,497
|
|
|
6,605
|
|
Total liabilities
|
|
|
132,892
|
|
|
131,818
|
|
|
|
|
|
|
|
Common stock subject to conditional redemption
|
|
|
12,345
|
|
|
12,345
|
|
Stockholders' equity
|
|
|
1,954
|
|
|
29,115
|
|
Total liabilities and stockholders' equity
|
|
$
|
147,191
|
|
$
|
173,278
|
Ligand Pharmaceuticals Incorporated
John L. Higgins, President and
CEO
Erika Luib, Investor Relations
(858) 550-7896
or
Lippert/Heilshorn
& Associates
Don Markley
dmarkley@lhai.com
(310)
691-7100