UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
__________________
FORM
8-K
__________________
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event
reported): July
28, 2009
Lexicon
Pharmaceuticals, Inc.
(Exact
name of registrant as specified in its charter)
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Delaware
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000-30111
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76-0474169
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(State
or other jurisdiction of
incorporation
or organization)
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(Commission
File Number)
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(I.R.S.
Employer
Identification
Number)
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8800
Technology Forest Place
The
Woodlands, Texas 77381
(Address
of principal executive offices
and Zip Code)
(281) 863-3000
(Registrant’s
telephone number, including
area code)
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligations of the registrant under any of the following
provisions:
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□
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Written
communications pursuant to Rule 425 under the Securities Act
(17 CFR 230.425)
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□
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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□
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act
(17 CFR 240.14d-2(b))
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□
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act
(17 CFR 240.13e-4(c))
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Item
2.02
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Results
of Operations and Financial
Condition
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On July
28, 2009, we issued a press release to report our financial results for the
quarter ended June 30, 2009. A copy of the press release is attached
to this current report on Form 8-K as Exhibit 99.1.
The
information in this Form 8-K and the Exhibit attached to this Form 8-K shall not
be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of
1934 (the “Exchange Act”) or otherwise subject to the liabilities of that
section, nor shall it be deemed incorporated by reference in any filing under
the Securities Act of 1933 or the Exchange Act, except as expressly set forth by
specific reference in such a filing.
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Item
9.01
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Financial
Statements and Exhibits
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(d) Exhibits
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Exhibit No.
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Description
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99.1
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— Press
Release of Lexicon Pharmaceuticals, Inc. dated July 28,
2009
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Signatures
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
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Lexicon
Pharmaceuticals, Inc.
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/s/
Jeffrey L. Wade
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Date: July
28, 2009
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By:
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Jeffrey
L. Wade
Executive Vice President
and
General
Counsel
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Index
to Exhibits
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Exhibit No.
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Description
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99.1
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— Press
Release of Lexicon Pharmaceuticals, Inc. dated July 28,
2009
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Exhibit
99.1
LEXICON
PHARMACEUTICALS PROVIDES CLINICAL PIPELINE UPDATE AND
REPORTS
2009 SECOND QUARTER FINANCIAL RESULTS
Conference
Call and Webcast at 11:00 a.m. Eastern Time
The Woodlands, Texas, July 28,
2009 – Lexicon Pharmaceuticals, Inc.
(Nasdaq: LXRX), a biopharmaceutical company focused on discovering and
developing breakthrough treatments for human disease, today updated its drug
development progress and reported financial results for the three months and six
months ended June 30, 2009.
“Our
clinical development programs continue to progress, including the recent
initiation of a Phase 2 study of LX1032 in patients with carcinoid syndrome,”
said Dr. Arthur T. Sands, president and chief executive officer of Lexicon. “We
also expect to advance LX2931 for rheumatoid arthritis into a Phase 2 clinical
trial in the very near future.”
Key
Developments
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·
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Lexicon
advanced its LX1032 drug candidate, which has received Fast Track status
from the U.S. Food and Drug Administration (FDA), into a Phase 2a study in
patients with carcinoid syndrome. The Phase 2 clinical trial is designed
as a randomized, double-blind, placebo-controlled study to evaluate the
safety and tolerability of LX1032 and its effects on symptoms associated
with carcinoid syndrome. The study will include up to 28 patients with
carcinoid syndrome who are symptomatic despite treatment with currently
available therapy. In addition, Lexicon presented Phase 1 data for LX1032
at the Digestive Disease Week (DDW) annual meeting on June 1, 2009. Most
recently, Lexicon received orphan drug designation for LX1032 from the
European Medicines Agency.
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·
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Lexicon
completed the multiple ascending-dose portion of a Phase 1 study of its
LX4211 drug candidate to evaluate the safety, tolerability, and
pharmacokinetics of LX4211 in healthy volunteers over a seven-day dosing
period. Top-line results from the Phase 1 clinical trial will be available
later this quarter.
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·
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Lexicon
is preparing to initiate a Phase 2a study of LX2931 in patients with
rheumatoid arthritis. Lexicon has identified the clinical trial sites for
the Phase 2 study, and patient enrollment is expected to begin in the
third quarter of 2009. In addition, Lexicon presented Phase 1 data for
LX2931 at the European League Against Rheumatism (EULAR) annual meeting on
June 13, 2009.
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·
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Lexicon
continues to enroll patients in a Phase 2a clinical trial of its LX1031
drug candidate for non-constipating irritable bowel syndrome (IBS).
Enrollment is on track to be completed by year-end. The trial is designed
as a double-blind, randomized, placebo-controlled study to evaluate the
safety and tolerability of LX1031 and its effects on symptoms associated
with IBS. In addition, Lexicon presented Phase 1 data for LX1031 at the
Digestive Disease Week (DDW) annual meeting on May 31, 2009.
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·
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Ajay
Bansal, formerly of Tercica, Inc., was appointed executive vice president
of corporate development and chief financial officer, responsible for
leading the company’s pharmaceutical partnering and licensing efforts. Mr.
Bansal has more than 20 years of experience in the biotechnology and
pharmaceutical industry in corporate finance, corporate and business
development, strategic planning, and commercial operations.
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1
Financial
Results
Revenues: Lexicon’s revenues
for the three months ended June 30, 2009 decreased 69 percent to $3.0 million
from $9.6 million for the corresponding period in 2008. The decrease for the
three months ended June 30, 2009 was primarily attributable to lower revenue
recognized under Lexicon’s alliance agreements with Bristol-Myers Squibb, N.V.
Organon and Genentech, Inc. For the six months ended June 30, 2009, revenues
decreased 61 percent to $7.2 million from $18.5 million for the corresponding
period in 2008.
Research and Development
Expenses: Research and development expenses for the three months ended
June 30, 2009 decreased 33 percent to $20.2 million from $30.1 million for the
corresponding period in 2008. The decrease was primarily attributable to lower
salary and benefit costs, due to reductions in personnel offset in part by
associated severance costs, as well as lower external preclinical research and
development costs. For the six months ended June 30, 2009, research and
development expenses decreased 25 percent to $43.1 million from $57.5 million
for the corresponding period in 2008.
General and Administrative
Expenses: General and administrative expenses for the three months ended
June 30, 2009 decreased six percent to $5.6 million from $5.9 million for the
corresponding period in 2008. The decrease was primarily attributable to lower
salary and benefit costs. For the six months ended June 30, 2009, general and
administrative expenses decreased 11 percent to $10.4 million from $11.8 million
for the corresponding period in 2008.
Net
Loss Attributable to Lexicon Pharmaceuticals, Inc.: Net loss for the
three months ended June 30, 2009 was $20.1 million, or $0.15 per share, compared
to a net loss of $20.0 million, or $0.15 per share, in the corresponding period
in 2008. Net loss for the six months ended June 30, 2009 was $41.6 million, or
$0.30 per share, compared to a net loss of $38.0 million, or $0.28 per share,
for the corresponding period in 2008. For the three and six months ended June
30, 2009, net loss included non-cash, stock-based compensation expense of $1.4
million and $2.8 million, respectively. For the three and six months ended June
30, 2008, net loss included non-cash, stock-based compensation expense of $1.6
million and $3.4 million, respectively.
Cash and Investments: As of
June 30, 2009, Lexicon had $106.9 million in cash and investments net of its
obligations under the credit line secured by its auction rate securities, as
compared to $130.8 million as of March 31, 2009 and $158.8 million as of
December 31, 2008.
Lexicon
Conference Call:
Lexicon
management will hold a conference call to discuss its clinical development
progress and financial results for the second quarter of 2009 at 11:00 a.m.
Eastern Time on July 28, 2009. The dial-in number for the conference call is
888-220-1244 (within the US/Canada) or 706-679-5615 (international). The
conference ID for all callers is 17788499. Investors can access a live webcast
of the call at www.lexpharma.com. An archived version of the webcast will be
available on the website through August 4, 2009.
About
Lexicon
Lexicon
is a biopharmaceutical company focused on discovering and developing
breakthrough treatments for human disease. Lexicon currently has five drug
candidates in development for autoimmune disease, carcinoid syndrome, diabetes,
glaucoma and irritable bowel syndrome, all of which were discovered by Lexicon’s
research team. Lexicon has used its proprietary gene knockout technology to
identify more than 100 promising drug targets. Lexicon has focused drug
discovery efforts on these biologically-validated targets to create its
extensive pipeline of clinical and preclinical programs. For additional
information about Lexicon and its programs, please visit
www.lexpharma.com.
2
Safe
Harbor Statement
This
press release contains “forward-looking statements,” including statements
relating to Lexicon’s clinical development of LX1031, LX1032, LX2931, and LX4211
and the potential therapeutic and commercial potential of LX1031, LX1032,
LX2931, and LX4211. This press release also contains forward-looking statements
relating to Lexicon’s growth and future operating results, discovery and
development of products, strategic alliances and intellectual property, as well
as other matters that are not historical facts or information. All
forward-looking statements are based on management’s current assumptions and
expectations and involve risks, uncertainties and other important factors,
specifically including those relating to Lexicon’s ability to successfully
conduct clinical development of LX1031, LX1032, LX2931, and LX4211 and
preclinical and clinical development of its other potential drug candidates,
advance additional candidates into preclinical and clinical development, obtain
necessary regulatory approvals, achieve its operational objectives, obtain
patent protection for its discoveries and establish strategic alliances, as well
as additional factors relating to manufacturing, intellectual property rights,
and the therapeutic or commercial value of its drug candidates, that may cause
Lexicon’s actual results to be materially different from any future results
expressed or implied by such forward-looking statements. Information identifying
such important factors is contained under “Factors Affecting Forward-Looking
Statements” and “Risk Factors” in Lexicon’s annual report on Form 10-K for the
year ended December 31, 2008, as filed with the Securities and Exchange
Commission. Lexicon undertakes no obligation to update or revise any such
forward-looking statements, whether as a result of new information, future
events or otherwise.
# #
#
Contact
for Lexicon:
Jason
Ray
Manager,
Corporate Communications and Investor Relations
281/863-3225
jray@lexpharma.com
3
Lexicon
Pharmaceuticals, Inc.
Selected
Financial Data
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Consolidated
Statements of Operations Data
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Three
Months Ended
June
30,
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Six
Months Ended
June
30,
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||||||||||||||
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(In
thousands, except per share data)
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2009
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2008
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2009
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2008
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||||||||||||
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(unaudited)
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(unaudited)
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|||||||||||||||
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Revenues:
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||||||||||||||||
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Collaborative research
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$ | 2,787 | $ | 7,953 | $ | 6,392 | $ | 15,587 | ||||||||
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Subscription and license fees
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202 | 1,613 | 765 | 2,872 | ||||||||||||
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Total revenues
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2,989 | 9,566 | 7,157 | 18,459 | ||||||||||||
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Operating
expenses:
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||||||||||||||||
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Research
and development, including stock-based compensation of
$766, $950, $1,595 and $2,077, respectively
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20,220 | 30,075 | 43,084 | 57,524 | ||||||||||||
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General
and administrative, including stock-based compensation of
$590, $633, $1,203 and $1,285, respectively
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5,551 | 5,877 | 10,425 | 11,759 | ||||||||||||
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Total operating expenses
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25,771 | 35,952 | 53,509 | 69,283 | ||||||||||||
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Loss
from operations
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(22,782 | ) | (26,386 | ) | (46,352 | ) | (50,824 | ) | ||||||||
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Gain
on long-term investments
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306 | — | 823 | — | ||||||||||||
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Interest
income
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239 | 1,418 | 566 | 4,199 | ||||||||||||
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Interest
expense
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(729 | ) | (675 | ) | (1,395 | ) | (1,345 | ) | ||||||||
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Other
expense, net
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(576 | ) | (539 | ) | (1,521 | ) | (1,086 | ) | ||||||||
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Consolidated
net loss
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(23,542 | ) | (26,182 | ) | (47,879 | ) | (49,056 | ) | ||||||||
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Loss
attributable to noncontrolling interest in Symphony Icon,
Inc.
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3,469 | 6,148 | 6,246 | 11,072 | ||||||||||||
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Net
loss attributable to Lexicon Pharmaceuticals, Inc.
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$ | (20,073 | ) | $ | (20,034 | ) | $ | (41,633 | ) | $ | (37,984 | ) | ||||
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Net
loss attributable to Lexicon Pharmaceuticals, Inc. per common share, basic
and diluted
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$ | (0.15 | ) | $ | (0.15 | ) | $ | (0.30 | ) | $ | (0.28 | ) | ||||
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Shares
used in computing net loss attributable to Lexicon Pharmaceuticals, Inc.
per common share, basic and diluted
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137,331 | 136,796 | 137,203 | 136,795 | ||||||||||||
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Consolidated
Balance Sheet Data
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As
of June 30,
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As
of December 31,
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||||||
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(In
thousands)
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2009
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2008
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||||||
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(unaudited)
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||||||||
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Cash
and investments, including cash and investments held by Symphony Icon,
Inc.
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$ | 143,814 | $ | 158,798 | ||||
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Obligations
under line of credit
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(36,957 | ) | — | |||||
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Cash
and investments, net of obligations under line of credit
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106,857 | 158,798 | ||||||
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Property
and equipment, net
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61,526 | 65,087 | ||||||
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Goodwill
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25,798 | 25,798 | ||||||
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Total
assets
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244,333 | 261,508 | ||||||
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Deferred
revenue
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15,486 | 19,884 | ||||||
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Current
and long-term debt, including line of credit
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66,974 | 30,492 | ||||||
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Noncontrolling
interest in Symphony Icon, Inc.
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4,001 | 10,247 | ||||||
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Accumulated
deficit
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(529,028 | ) | (487,395 | ) | ||||
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Total
Lexicon Pharmaceuticals, Inc. stockholders’ equity
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147,109 | 185,580 | ||||||