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): October
27, 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
October 27, 2009, we issued a press release to report our financial results for
the quarter ended September 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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—
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Press
Release of Lexicon Pharmaceuticals, Inc. dated October 27,
2009
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2
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: October
27, 2009
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By:
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Jeffrey
L. Wade
Executive Vice President
and
General
Counsel
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3
Index
to Exhibits
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Exhibit No.
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Description
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99.1
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—
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Press
Release of Lexicon Pharmaceuticals, Inc. dated October 27,
2009
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Exhibit
99.1
LEXICON
PHARMACEUTICALS PROVIDES CLINICAL PIPELINE UPDATE
AND
REPORTS 2009 THIRD QUARTER FINANCIAL RESULTS
Conference
Call and Webcast at 11:00 a.m. Eastern Time
The Woodlands, Texas, October 27,
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 and nine months ended September 30, 2009.
“We
advanced our fourth drug candidate into Phase 2 clinical trials during the third
quarter, as we continue to focus our resources on the research and development
of our most promising programs,” said Dr. Arthur T. Sands,
president and chief executive officer of Lexicon. “We are now looking
forward to reporting Phase 2 clinical results from our four programs in patients
over the next 12 months, including top-line results from LX1031 in November
2009.”
Key
Developments
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§
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Lexicon
completed patient enrollment ahead of schedule in a Phase 2a clinical
trial of its drug candidate for non-constipating irritable bowel
syndrome (IBS), LX1031, an
inhibitor of tryptophan hydroxylase that acts locally in the
gastrointestinal tract. Top-line data from the trial is
expected to be available in November 2009, with detailed results available
in the first quarter of 2010.
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§
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Lexicon
completed Phase 1 studies of its drug candidate for type 2
diabetes, LX4211, an
inhibitor of sodium-glucose cotransporter 2 (SGLT2). The
company also initiated a Phase 2a clinical trial of the drug candidate in
patients with diabetes. In the Phase 1 clinical trial, LX4211
was well tolerated at all dose levels and produced a dose-dependent
increase in urinary glucose excretion. LX4211 also demonstrated a
favorable pharmacokinetic profile supporting the potential for once daily
dosing. The Phase 2 clinical trial is designed as a four-week,
randomized, double-blind, placebo-controlled study to evaluate the safety
and tolerability of LX4211 and its effect on biomarkers associated with
type 2 diabetes. The trial will be conducted in the United
States and is expected to enroll 36 patients with non-insulin dependent
type 2 diabetes. Top-line data from the trial is expected to be
available in the first quarter of
2010.
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§
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Lexicon
advanced LX2931, an
inhibitor of sphingosine-1-phosphate (S1P) lyase, into a Phase 2a study in
patients with rheumatoid
arthritis. The Phase 2 clinical trial is designed as a
12-week, randomized, double-blind, placebo-controlled study to evaluate
the safety and tolerability of LX2931 and its effects on symptoms
associated with rheumatoid arthritis. The study will include up to
120 patients and will be conducted at multiple centers in the United
States and Eastern Europe. Top-line data from the trial is
expected to be available in the third quarter of
2010.
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§
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Lexicon
continues to enroll patients in a Phase 2a study of its drug candidate for
carcinoid
syndrome, LX1032, an
inhibitor of tryptophan hydroxylase that reduces peripheral serotonin
production without affecting brain serotonin levels. 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. Top-line data from the trial is expected to be
available by the third quarter of
2010.
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1
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§
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In
October 2009, Lexicon completed the public offering and sale of 38.3
million shares of its common stock at $1.50 per share. The net
proceeds of the offering were $55.2 million, after deducting
underwriting discounts and offering
expenses.
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Financial
Results
Revenues: Lexicon’s
revenues for the three months ended September 30, 2009 decreased 72 percent to
$2.1 million from $7.5 million for the corresponding period in
2008. The decrease was primarily attributable to reduced revenues
under Lexicon’s alliances with Bristol-Myers Squibb, N.V. Organon and Genentech,
Inc., partially offset by increases in revenue under the company’s collaboration
with Taconic Farms, Inc. For the nine months ended September 30,
2009, revenues decreased 64 percent to $9.3 million from $26.0 million for the
corresponding period in 2008.
Research and Development
Expenses: Research and development expenses for the three
months ended September 30, 2009 decreased 29 percent to $19.3 million from $27.3
million for the corresponding period in 2008. The decrease was
primarily attributable to lower external preclinical research and development
expenses as well as lower salary and benefit costs. For the nine
months ended September 30, 2009, research and development expenses decreased 26
percent to $62.4 million from $84.9 million for the corresponding period in
2008.
General and Administrative
Expenses: General and administrative expenses for the three
months ended September 30, 2009 decreased eight percent to $4.6 million from
$5.0 million for the corresponding period in 2008. The decrease was
primarily attributable to lower consulting expenses. For the nine
months ended September 30, 2009, general and administrative expenses
decreased 10 percent to $15.0 million from $16.7 million for the
corresponding period in 2008.
Net Loss Attributable to Lexicon
Pharmaceuticals, Inc.: Net loss for the three months ended
September 30, 2009 was $19.1 million, or $0.14 per share, compared to a net loss
of $23.5 million, or $0.17 per share, in the corresponding period in
2008. Net loss for the nine months ended September 30, 2009 was $60.8
million, or $0.44 per share, compared to a net loss of $61.4 million, or $0.45
per share, for the corresponding period in 2008. For the three and
nine months ended September 30, 2009, net loss included non-cash, stock-based
compensation expense of $1.3 million and $4.1 million,
respectively. For the three and nine months ended September 30, 2008,
net loss included non-cash, stock-based compensation expense of
$1.4 million and $4.8 million, respectively.
Cash and
Investments: As of September 30, 2009, Lexicon had $87.3
million in cash and investments net of its obligations under the credit line
secured by its auction rate securities, as compared to $106.9 million as of June
30, 2009 and $158.8 million as of December 31, 2008. The $87.3
million in cash and investments as of September 30, 2009 does not include the
$55.2 million in net proceeds the company recently received from its public
offering in October 2009.
Lexicon
Conference Call:
Lexicon
management will hold a conference call to discuss its clinical development
progress and financial results for the third quarter of 2009 at 11:00 a.m.
Eastern Time on October 27, 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
November 2, 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
September
30,
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Nine
Months Ended
September
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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Revenues:
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||||||||||||||||
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Collaborative research
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$ | 1,650 | $ | 7,202 | $ | 8,042 | $ | 22,789 | ||||||||
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Subscription and license fees
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481 | 310 | 1,246 | 3,182 | ||||||||||||
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Total revenues
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2,131 | 7,512 | 9,288 | 25,971 | ||||||||||||
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Operating
expenses:
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||||||||||||||||
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Research
and development, including stock-based compensation
of
$733, $836, $2,328 and $2,913, respectively
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19,320 | 27,344 | 62,404 | 84,868 | ||||||||||||
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General
and administrative, including stock-based compensation
of
$547, $583, $1,750 and $1,868, respectively
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4,568 | 4,990 | 14,993 | 16,749 | ||||||||||||
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Total operating expenses
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23,888 | 32,334 | 77,397 | 101,617 | ||||||||||||
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Loss
from operations
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(21,757 | ) | (24,822 | ) | (68,109 | ) | (75,646 | ) | ||||||||
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Gain
(loss) on investments, net
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185 | (3,322 | ) | 1,008 | (3,322 | ) | ||||||||||
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Interest
income
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103 | 956 | 669 | 5,155 | ||||||||||||
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Interest
expense
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(785 | ) | (675 | ) | (2,180 | ) | (2,020 | ) | ||||||||
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Other
expense, net
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(516 | ) | (535 | ) | (2,037 | ) | (1,621 | ) | ||||||||
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Consolidated
loss before income taxes
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(22,770 | ) | (28,398 | ) | (70,649 | ) | (77,454 | ) | ||||||||
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Income
tax benefit
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102 | — | 102 | — | ||||||||||||
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Consolidated
net loss
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(22,668 | ) | (28,398 | ) | (70,547 | ) | (77,454 | ) | ||||||||
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Loss
attributable to noncontrolling interest in Symphony Icon,
Inc.
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3,526 | 4,939 | 9,772 | 16,011 | ||||||||||||
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Net
loss attributable to Lexicon Pharmaceuticals, Inc.
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$ | (19,142 | ) | $ | (23,459 | ) | $ | (60,775 | ) | $ | (61,443 | ) | ||||
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Net
loss attributable to Lexicon Pharmaceuticals, Inc. per common share, basic
and diluted
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$ | (0.14 | ) | $ | (0.17 | ) | $ | (0.44 | ) | $ | (0.45 | ) | ||||
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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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137,313 | 136,796 | 137,240 | 136,796 | ||||||||||||
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Consolidated
Balance Sheet Data
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As
of September 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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$ | 125,146 | $ | 158,798 | ||||
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Obligations
under line of credit
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(37,835 | ) | — | |||||
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Cash
and investments, net of obligations under line of credit
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87,311 | 158,798 | ||||||
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Property
and equipment, net
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60,090 | 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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223,684 | 261,508 | ||||||
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Deferred
revenue
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15,293 | 19,884 | ||||||
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Current
and long-term debt, including line of credit
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67,614 | 30,492 | ||||||
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Noncontrolling
interest in Symphony Icon, Inc.
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475 | 10,247 | ||||||
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Accumulated
deficit
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(548,170 | ) | (487,395 | ) | ||||
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Total
Lexicon Pharmaceuticals, Inc. stockholders’ equity
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129,424 | 185,580 | ||||||