THE WOODLANDS, Texas,
March 4, 2015 /PRNewswire/
-- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a
biopharmaceutical company focused on developing breakthrough
treatments for human disease, today updated its drug development
progress and reported financial results for the three months and
year ended December 31, 2014.
"We enter 2015 in a strong financial position to develop our two
lead drug candidates, telotristat etiprate and sotagliflozin," said
Lonnel Coats, Lexicon's president and chief executive officer.
"This year will be key for Lexicon as we complete a pivotal Phase 3
trial of telotristat etiprate in patients with carcinoid syndrome
and initiate Phase 3 trials for sotagliflozin in patients with type
1 diabetes."
In October 2014, Lexicon completed
a collaboration agreement with Ipsen Pharma SAS for the
commercialization of telotristat etiprate, with a focus on
carcinoid syndrome, in markets outside the United States, Canada and Japan. Under the agreement,
Lexicon is eligible to receive up to approximately $145 million in aggregate upfront and milestone
payments, including an upfront payment of $23 million. In addition, Lexicon is
entitled to receive royalties on net sales of telotristat etiprate
by Ipsen.
Also in the fourth quarter of 2014, Lexicon completed concurrent
debt and equity financings that resulted in gross proceeds of
$293.4 million. After fees and
offering expenses, the financings resulted in net proceeds of
$286.0 million and are reflected in
the company's financial results as of December 31, 2014. In the aggregate, the
financings consisted of the issuance of approximately 204.9 million
shares of common stock, with gross proceeds of $205.9 million, and $87.5
million in aggregate principal amount of 5.25% convertible
senior notes due 2021.
Progress in Clinical Pipeline
- Telotristat etiprate (LX1032): Lexicon is nearing
completion of enrollment in TELESTAR, its pivotal Phase 3 clinical
trial of telotristat etiprate in carcinoid syndrome, with the last
patient expected to be randomized in March
2015. Telotristat etiprate is an inhibitor of
tryptophan hydroxylase (TPH) that reduces peripheral serotonin
production without affecting brain serotonin levels.
- Sotagliflozin (LX4211): Lexicon continues to progress
with the initiation of Phase 3 clinical trials of sotagliflozin in
type 1 diabetes, with the anticipation that enrollment will
commence in the first half of 2015. Sotagliflozin is a dual
inhibitor of sodium-glucose transporters 1 and 2 (SGLT1 and
SGLT2). In parallel with Phase 3, Lexicon is also progressing
with a Phase 2 clinical trial of sotagliflozin in collaboration
with JDRF, focused in individuals with type 1 diabetes younger than
age 30 with high A1C, representative of a population of
particularly high unmet need.
Financial Results
Revenues: Lexicon's revenues for the three months
ended December 31, 2014 increased to
$21.5 million from $1.4 million for the corresponding period in
2013, primarily due to revenues recognized from the license and
collaboration agreement with Ipsen Pharma SAS. For the year
ended December 31, 2014, revenues
increased to $22.9 million from
$2.2 million for the corresponding
period in 2013.
Research and Development Expenses: Research and
development expenses for the three months ended December 31, 2014 decreased one percent to
$20.0 million from $20.3 million for the corresponding period in
2013. For the year ended December 31,
2014, research and development expenses decreased to
$89.3 million from $89.7 million for the corresponding period in
2013.
Change in Fair Value of Symphony Icon Purchase
Liability: In connection with the acquisition of Symphony
Icon, Lexicon made an initial estimate of the fair value of the
liability for the associated base and contingent payments.
Changes in this liability, based on the development of the
programs and the time until such payments are expected to be made,
are recorded in Lexicon's consolidated statements of operations.
For the three months ended December 31,
2014, the fair value of the Symphony Icon purchase liability
increased by $0.9 million as compared
to a decrease of $5.3 million in the
corresponding period in 2013. For the year ended December 31, 2014, the fair value of the Symphony
Icon purchase liability increased by $1.4
million as compared to a decrease of $2.2 million in the corresponding period in
2013.
General and Administrative Expenses: General and
administrative expenses for the three months ended December 31, 2014 increased 17 percent to
$4.0 million from $3.4 million for the corresponding period in
2013. For the year ended December 31,
2014, general and administrative expenses increased 13
percent to $19.4 million from
$17.1 million for the corresponding
period in 2013.
Impairment Loss on Buildings: In September 2014, Lexicon determined its buildings
and land should be classified as assets held for sale.
Lexicon recognized a non-cash impairment loss on its buildings of
$13.1 million for the year ended
December 31, 2014, as a result of
writing down the buildings to the estimated net selling price.
Consolidated Net Loss: Net loss for the three
months ended December 31, 2014 was
$2.9 million, or $0.00 per share, compared to a net loss of
$17.4 million, or $0.03 per share, in the corresponding period in
2013. Net loss for the year ended December 31, 2014 was $100.3 million, or $0.19 per share, compared to a net loss of
$104.1 million, or $0.20 per share, for the corresponding period in
2013. For the three months and year ended December 31, 2014, net loss included non-cash,
stock-based compensation expense of $1.5
million and $7.1 million,
respectively. For the three months and year ended
December 31, 2013, net loss included
non-cash, stock-based compensation expense of $1.7 million and $7.4
million, respectively.
Cash and Investments: As of December 31, 2014, Lexicon had $339.3 million in cash and investments, as
compared to $57.9 million as of
September 30, 2014 and $129.1 million as of December 31, 2013.
Lexicon Conference Call
Lexicon management will hold a conference call to discuss its
clinical development progress and financial results for 2014 and
financial guidance for 2015 at 10:00 a.m.
Eastern Time on March 4, 2015.
The dial-in number for the conference call is 888-645-5785
(within the US/Canada) or
970-300-1531 (international). The conference ID for all
callers is 98067025. 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 April 4, 2015.
About Lexicon
Lexicon is a biopharmaceutical company focused on developing
breakthrough treatments for human disease. Lexicon has
clinical-stage drug programs for diabetes, carcinoid syndrome, and
other indications, 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.
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
sotagliflozin (LX4211) and telotristat etiprate (LX1032), including
characterizations of the results of and projected timing of
clinical trials and the potential therapeutic and commercial
potential of sotagliflozin and telotristat etiprate. In
addition, 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 meet its capital requirements, successfully conduct clinical
development of sotagliflozin and telotristat etiprate and
preclinical and clinical development of its other potential drug
candidates, 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 "Risk Factors" in
Lexicon's annual report on Form 10-K for the year ended
December 31, 2013, 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
December
31,
|
|
Year
Ended December
31,
|
(In thousands, except
per share data)
|
2014
|
|
2013
|
|
2014
|
|
2013
|
|
(unaudited)
|
|
(unaudited)
|
Revenues:
|
|
|
|
|
|
|
|
Collaborative agreements
|
$ 21,482
|
|
$ 1,376
|
|
$ 22,593
|
|
$ 2,109
|
Subscription and license fees
|
-
|
|
34
|
|
261
|
|
113
|
Total revenues
|
21,482
|
|
1,410
|
|
22,854
|
|
2,222
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development, including stock-based compensation of $825, $997, $4,020 and $4,376,
respectively
|
20,031
|
|
20,263
|
|
89,279
|
|
89,682
|
Increase (decrease) in
fair value of Symphony Icon, Inc. purchase liability
|
910
|
|
(5,289)
|
|
1,428
|
|
(2,210)
|
General and
administrative, including stock-based compensation
of $672, $696, $3,061 and $3,045,
respectively
|
3,988
|
|
3,412
|
|
19,411
|
|
17,121
|
Impairment loss on
buildings
|
-
|
|
-
|
|
13,102
|
|
-
|
Total operating expenses
|
24,929
|
|
18,386
|
|
123,220
|
|
104,593
|
Loss from
operations
|
(3,447)
|
|
(16,976)
|
|
(100,366)
|
|
(102,371)
|
Interest
expense
|
(892)
|
|
(477)
|
|
(2,253)
|
|
(1,971)
|
Interest and other
income, net
|
1,336
|
|
39
|
|
2,255
|
|
216
|
Consolidated net loss
before taxes
|
(3,003)
|
|
(17,414)
|
|
(100,364)
|
|
(104,126)
|
Income tax
benefit
|
70
|
|
-
|
|
70
|
|
-
|
Consolidated net
loss
|
$ (2,933)
|
|
$ (17,414)
|
|
$ (100,294)
|
|
$ (104,126)
|
|
|
|
|
|
|
|
|
Consolidated net loss
per common share, basic and diluted
|
$ 0.00
|
|
$ (0.03)
|
|
$ (0.19)
|
|
$ (0.20)
|
|
|
|
|
|
|
|
|
Shares used in
computing net loss attributable to Lexicon Pharmaceuticals,
Inc. per common share, basic and diluted
|
593,694
|
|
513,523
|
|
534,432
|
|
513,117
|
Consolidated
Balance Sheet Data
|
As of December
31,
|
|
As of December
31,
|
(In
thousands)
|
2014
|
|
2013
|
|
(unaudited)
|
|
|
Cash and
investments
|
$ 339,339
|
|
$ 129,128
|
Assets held for
sale
|
23,849
|
|
-
|
Property and
equipment, net
|
1,080
|
|
41,362
|
Goodwill
|
44,543
|
|
44,543
|
Other intangible
assets
|
53,357
|
|
53,557
|
Total
assets
|
471,376
|
|
274,160
|
Deferred
revenue
|
14,297
|
|
13,600
|
Current and long-term
debt
|
107,667
|
|
21,877
|
Other long-term
liabilities
|
23,535
|
|
32,386
|
Accumulated
deficit
|
(1,104,252)
|
|
(1,003,958)
|
Total stockholders'
equity
|
284,018
|
|
170,163
|
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SOURCE Lexicon Pharmaceuticals, Inc.