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"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
-- 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.
-- 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.
-- 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.
-- 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.
-- 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.
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.
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.
Lexicon Pharmaceuticals, Inc.
Selected Financial Data
Consolidated Statements Three Months Ended Nine Months Ended
of Operations Data September 30, September 30,
------------- -------------
(In thousands, except per
share data) 2009 2008 2009 2008
---- ---- ---- ----
(unaudited) (unaudited)
Revenues:
Collaborative research $1,650 $7,202 $8,042 $22,789
Subscription and license
fees 481 310 1,246 3,182
--- --- ----- -----
Total revenues 2,131 7,512 9,288 25,971
Operating expenses:
Research and development,
including stock-based
compensation of $733, $836,
$2,328 and $2,913,
respectively 19,320 27,344 62,404 84,868
General and administrative,
including stock-based
compensation of $547,
$583, $1,750 and $1,868,
respectively 4,568 4,990 14,993 16,749
----- ----- ------ ------
Total operating expenses 23,888 32,334 77,397 101,617
------ ------ ------ -------
Loss from operations (21,757) (24,822) (68,109) (75,646)
Gain (loss) on investments,
net 185 (3,322) 1,008 (3,322)
Interest income 103 956 669 5,155
Interest expense (785) (675) (2,180) (2,020)
Other expense, net (516) (535) (2,037) (1,621)
---- ---- ------ ------
Consolidated loss before
income taxes (22,770) (28,398) (70,649) (77,454)
Income tax benefit 102 - 102 -
--- --- --- ---
Consolidated net loss (22,668) (28,398) (70,547) (77,454)
Loss attributable to
noncontrolling interest
in Symphony Icon, Inc. 3,526 4,939 9,772 16,011
----- ----- ----- ------
Net loss attributable to
Lexicon Pharmaceuticals,
Inc. $(19,142) $(23,459) $(60,775) $(61,443)
======== ======== ======== ========
Net loss attributable to
Lexicon Pharmaceuticals,
Inc. per common share,
basic and diluted $(0.14) $(0.17) $(0.44) $(0.45)
====== ====== ====== ======
Shares used in computing
net loss attributable
to Lexicon
Pharmaceuticals, Inc.
per common share, basic
and diluted 137,313 136,796 137,240 136,796
Consolidated Balance Sheet Data As of As of
September 30, December 31,
(In thousands) 2009 2008
---- ----
(unaudited)
Cash and investments, including cash
and investments held by Symphony Icon,
Inc. $125,146 $158,798
Obligations under line of credit (37,835) -
------- ---
Cash and investments, net of
obligations under line of credit 87,311 158,798
Property and equipment, net 60,090 65,087
Goodwill 25,798 25,798
Total assets 223,684 261,508
Deferred revenue 15,293 19,884
Current and long-term debt, including
line of credit 67,614 30,492
Noncontrolling interest in Symphony
Icon, Inc. 475 10,247
Accumulated deficit (548,170) (487,395)
Total Lexicon Pharmaceuticals, Inc.
stockholders' equity 129,424 185,580
SOURCE Lexicon Pharmaceuticals, Inc.
http://www.lexpharma.com
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