THE WOODLANDS, Texas,
Nov. 5, 2010 /PRNewswire-FirstCall/
-- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a
biopharmaceutical company focused on discovering breakthrough
treatments for human disease, today updated the progress of its
drug development programs and reported financial results for the
three and nine months ended September 30,
2010.
"Having established proof-of-concept for two new mechanisms of
action in irritable bowel syndrome and diabetes, we are now
preparing our drug candidates for the next phase of development,
with a focus on formulation and dose selection in order to optimize
the ultimate commercial product opportunity for these programs,"
said Dr. Arthur T. Sands, president and chief executive officer of
Lexicon. "Over the coming months, we are also looking forward
to two more proof-of-concept results in rheumatoid arthritis and
carcinoid syndrome."
Key Progress in Clinical Pipeline
- Diabetes: Lexicon continues to progress its dual
sodium-glucose cotransporter 1 (SGLT1) and SGLT2 inhibitor, LX4211,
in patients with type 2 diabetes. In preparation for a
12-week Phase 2b study that is anticipated to initiate around
mid-year 2011, a 13-week toxicology study was completed, a
prototype tablet has been formulated, and a
pharmacokinetic/pharmacodynamic study in humans has been initiated
to evaluate the bioequivalence of the solid oral formulation
compared to the liquid formulation that was used in the previous
studies and to further evaluate various measures of glucose control
and GLP-1 signaling.
- Irritable Bowel Syndrome: Reformulation of LX1031
has progressed with the goal of achieving a lower and less frequent
dosing regimen that will provide a similar safety and efficacy
profile to that observed with the original formulation. In
addition, LX1033, a back-up compound that is approximately 10-fold
more potent than LX1031, has completed IND-enabling studies.
It is anticipated that LX1033 will commence Phase 1 testing
in the first quarter of 2011.
- Rheumatoid Arthritis: Lexicon completed dosing in
the expanded Phase 2a clinical trial of its drug candidate for
rheumatoid arthritis, LX2931, an inhibitor of
sphingosine-1-phosphate lyase. Top-line data from the study,
which enrolled 208 patients and was conducted at multiple centers
in the United States and
Eastern Europe, are expected to be
available by the end of the year.
- Carcinoid Syndrome: Enrollment in both
the United States and Europe is continuing in the Phase 2a trials
for LX1032, an inhibitor of tryptophan hydroxylase that reduces
peripheral serotonin production without affecting brain serotonin
levels. Preliminary data from both trials are expected to be
available in the first half of 2011.
Financial Results and Events
On July 30, 2010, Lexicon
exercised a restructured purchase option under its drug development
financing collaboration with Symphony Icon Holdings LLC and
acquired all the equity of Symphony Icon, Inc., thereby reacquiring
all rights to LX1031, LX1032, LX1033 and the other drug programs
subject to the collaboration. Pursuant to the amended terms
of the purchase option, Lexicon paid Symphony Icon Holdings LLC
$10 million and agreed to make up to
$80 million in additional base and
contingent payments.
Revenues: Lexicon's revenues for the three months
ended September 30, 2010 decreased 63
percent to $0.8 million from
$2.1 million for the corresponding
period in 2009. The decrease for the three months ended
September 30, 2010 was primarily
attributable to reduced revenues under Lexicon's alliance
agreements with Taconic Farms and Bristol-Myers Squibb Company.
For the nine months ended September
30, 2010, revenues decreased 61 percent to $3.7 million from $9.3
million for the corresponding period in 2009.
Research and Development Expenses: Research and
development expenses for the three months ended September 30, 2010 increased four percent to
$20.1 million from $19.3 million for the corresponding period in
2009. For the nine months ended September 30, 2010, research and development
expenses decreased two percent to $61.4
million from $62.4 million for
the corresponding period in 2009.
General and Administrative Expenses: General and
administrative expenses for the three months ended September 30, 2010 increased eight percent to
$4.9 million from $4.6 million for the corresponding period in
2009. The increase was primarily attributable to increases in
salary and benefit costs. For the nine months ended
September 30, 2010, general and
administrative expenses increased four percent to $15.5 million from $15.0 million for the corresponding period in
2009.
Net Loss Attributable to Lexicon Pharmaceuticals, Inc.:
Net loss for the three months ended September 30, 2010 was $27.5 million, or $0.08 per share, compared to a net loss of
$19.1 million, or $0.14 per share, in the corresponding period in
2009. Net loss for the nine months ended September 30, 2010 was $78.8 million, or $0.27 per share, compared to a net loss of
$60.8 million, or $0.44 per share, for the corresponding period in
2009. For the three and nine months ended September 30, 2010, net loss included non-cash,
stock-based compensation expense of $1.3
million and $4.0 million,
respectively. 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.
Cash and Investments: As of September 30, 2010, Lexicon had $231.0 million in cash and investments, as
compared to cash and investments, net of its obligations under the
credit line secured by its auction rate securities, of $255.8 million as of June
30, 2010 and $125.1 million as
of December 31, 2009. On
June 30, 2010, Lexicon exercised its
rights to require UBS AG to purchase its remaining auction rate
securities, and UBS purchased the auction rate securities at par
value on July 1, 2010.
Lexicon Conference Call:
Lexicon management will hold a conference call to discuss its
clinical development progress and financial results for the third
quarter of 2010 at 11:00 a.m. Eastern
Time on November 5, 2010.
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 20791091. 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 12, 2010.
About Lexicon
Lexicon is a biopharmaceutical company focused on discovering
breakthrough treatments for human disease. Lexicon currently
has four drug candidates in mid-stage development for diabetes,
irritable bowel syndrome, carcinoid syndrome and rheumatoid
arthritis, 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, LX1033, LX2931, and LX4211, including
characterizations of the results of and projected timing of
clinical trials of such compounds, and the potential therapeutic
and commercial potential of LX1031, LX1032, LX1033, 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, LX1033, 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. Unless specifically indicated otherwise, results
reported as trends were not statistically significant. 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, 2009, 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 of Operations Data
|
|
Three Months
Ended
September
30,
|
|
Nine Months
Ended
September
30,
|
|
(In
thousands, except per share data)
|
|
2010
|
|
2009
|
|
2010
|
|
2009
|
|
|
|
(unaudited)
|
|
(unaudited)
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
Collaborative
research
|
|
$ 632
|
|
$ 1,650
|
|
$ 3,437
|
|
$ 8,042
|
|
Subscription and license
fees
|
|
149
|
|
481
|
|
218
|
|
1,246
|
|
Total
revenues
|
|
781
|
|
2,131
|
|
3,655
|
|
9,288
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
Research and development,
including stock-based compensation
of $751, $733, $2,366 and
$2,328, respectively
|
|
20,086
|
|
19,320
|
|
61,413
|
|
62,404
|
|
General and
administrative, including stock-based compensation
of $582, $547, $1,592 and
$1,750, respectively
|
|
4,948
|
|
4,568
|
|
15,535
|
|
14,993
|
|
Total operating expenses
|
|
25,034
|
|
23,888
|
|
76,948
|
|
77,397
|
|
Loss from operations
|
|
(24,253)
|
|
(21,757)
|
|
(73,293)
|
|
(68,109)
|
|
Gain on investments,
net
|
|
-
|
|
185
|
|
141
|
|
1,008
|
|
Interest income
|
|
51
|
|
103
|
|
468
|
|
669
|
|
Interest expense
|
|
(637)
|
|
(785)
|
|
(2,093)
|
|
(2,180)
|
|
Other expense, net
|
|
(2,700)
|
|
(516)
|
|
(4,025)
|
|
(2,037)
|
|
Consolidated loss before
taxes
|
|
(27,539)
|
|
(22,770)
|
|
(78,802)
|
|
(70,649)
|
|
Income tax benefit
|
|
26
|
|
102
|
|
26
|
|
102
|
|
Consolidated net loss
|
|
(27,513)
|
|
(22,668)
|
|
(78,776)
|
|
(70,547)
|
|
Less: Net loss attributable to
noncontrolling interest in Symphony Icon, Inc.
|
|
-
|
|
3,526
|
|
-
|
|
9,772
|
|
Net loss attributable to Lexicon
Pharmaceuticals, Inc.
|
|
$ (27,513)
|
|
$ (19,142)
|
|
$ (78,776)
|
|
$ (60,775)
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to
Lexicon Pharmaceuticals, Inc. per common share, basic and
diluted
|
|
$ (0.08)
|
|
$ (0.14)
|
|
$ (0.27)
|
|
$ (0.44)
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing net
loss attributable to Lexicon Pharmaceuticals, Inc. per common
share, basic and diluted
|
|
337,404
|
|
137,313
|
|
291,196
|
|
137,240
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated
Balance Sheet Data
|
As of
September 30,
|
|
As of
December 31,
|
|
(In
thousands)
|
2010
|
|
2009
|
|
|
(unaudited)
|
|
|
|
Cash and
investments(1)
|
$ 231,018
|
|
$ 162,513
|
|
Obligations under line of
credit
|
-
|
|
(37,435)
|
|
Cash and investments, net of
obligations under line of credit(1)
|
231,018
|
|
125,078
|
|
|
|
|
|
|
Property and equipment,
net
|
55,404
|
|
58,754
|
|
Goodwill
|
25,798
|
|
25,798
|
|
Other intangible
assets
|
53,557
|
|
-
|
|
Total assets
|
370,873
|
|
257,761
|
|
Deferred revenue
|
15,059
|
|
15,154
|
|
Current and long-term debt,
including line of credit
|
28,754
|
|
66,964
|
|
Noncontrolling interest in
Symphony Icon, Inc.
|
-
|
|
(290)
|
|
Accumulated deficit
|
(650,407)
|
|
(570,175)
|
|
Total Lexicon Pharmaceuticals,
Inc. stockholders' equity
|
268,854
|
|
163,787
|
|
——————
|
|
|
|
|
(1)
Cash and investments at December 31, 2009 included $5.4
million held by Symphony Icon, Inc. As a result of Lexicon's
adoption as of January 1, 2010 of a new accounting
pronouncement regarding variable interest entities, the results of
Symphony Icon were not consolidated in Lexicon's financial
statements for the period from January 1, 2010 through the exercise
of the purchase option on July 30, 2010.
|
|
|
|
|
|
|
|
SOURCE Lexicon Pharmaceuticals, Inc.