THE WOODLANDS, Texas,
Nov. 6, 2015 /PRNewswire/
-- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today
reported financial results for the third quarter ended September 30, 2015 and provided an overview of
key milestones for the company's lead drug candidates.
Earlier today, Lexicon announced that it entered into a
collaboration and license agreement with Sanofi for the worldwide
development and commercialization of sotagliflozin. Under the
terms of the agreement, Lexicon will receive an upfront payment of
$300 million and is eligible to
receive development, regulatory and sales milestone payments of up
to $1.4 billion. Lexicon is
also entitled to tiered, escalating royalties on net sales of
sotagliflozin. The financial results reported in this press
release are as of September 30, 2015
and do not reflect any impact of this collaboration.
"As anticipated, 2015 has been a transformational year for
Lexicon and our two lead drug candidates, telotristat etiprate and
sotagliflozin," said Lexicon President and Chief Executive Officer
Lonnel Coats. "We announced positive
results from our pivotal Phase 3 TELESTAR study of telotristat
etiprate during the third quarter and earlier today we announced a
strategic collaboration with Sanofi that is designed to unlock the
full potential of sotagliflozin for patients living with
diabetes."
Pipeline Progress
Telotristat etiprate is the first investigational drug in
clinical studies to target tryptophan hydroxylase (TPH), an enzyme
that triggers the excess serotonin production within metastatic
neuroendocrine tumor cells that leads to carcinoid syndrome, a
condition characterized by serious consequences including frequent
and debilitating diarrhea, facial flushing, abdominal pain, and
heart valve damage.
Top-line results from Lexicon's Phase 3 TELESTAR study showed
that patients who added telotristat etiprate to the standard of
care at both the 250 mg and 500 mg doses experienced a
statistically significant reduction from baseline compared to
placebo in the average number of daily bowel movements over the
12-week study period (p<0.001), meeting the study's primary
endpoint.
Patients who received 250 mg of telotristat etiprate experienced
a reduction of 1.71 bowel movements (29%) in the average number of
daily bowel movements during the final week of the study compared
to baseline, and those in the 500 mg arm experienced a reduction of
2.11 bowel movements (35%); the placebo group showed a reduction of
0.87 bowel movements (17%).
A substantially greater proportion of patients on telotristat
etiprate achieved a durable response (44 percent and 42 percent in
the 250 mg and 500 mg arms, respectively), defined as at least a 30
percent reduction in daily bowel movements over at least half the
days of the study period, as compared to 20 percent response on
placebo (p<=0.02).
The mean change in urinary 5-HIAA, the main metabolite of
serotonin, from baseline to week 12 was a reduction of 40 mg/24
hours in the 250 mg arm and 58 mg/24 hours in the 500 mg arm versus
an increase of 11 mg/24 hours in the placebo group (p<0.001).
Baseline urinary 5-HIAA levels were 93 mg/24 hours in the 250 mg
arm, 90 mg/24 hours in the 500 mg arm, and 81 mg/24 hours in the
placebo group.
Patients who received telotristat etiprate also experienced a
lower frequency of flushing episodes and less intense abdominal
pain compared to placebo, though these differences did not reach
statistical significance.
Sotagliflozin is a dual inhibitor of sodium-glucose
transporters 1 and 2 (SGLT1 and SGLT2), which could be a potential
treatment option for people with diabetes. Sotagliflozin is the
first investigational medicine to target both of these two
proteins, each of which modulate glucose regulation.
Lexicon has initiated enrollment in three Phase 3 clinical
trials of sotagliflozin in patients with type 1 diabetes and
expects to have top-line results from its two pivotal Phase 3
clinical trials in the second half of 2016. With the
initiation of the collaboration with Sanofi, sotagliflozin is now
expected to be studied in Phase 3 clinical trials in patients with
type 2 diabetes starting in 2016. Lexicon will continue to be
responsible for clinical development activities relating to type 1
diabetes and Sanofi will be responsible for clinical development
activities relating to type 2 diabetes.
Financial Highlights
Revenues: Lexicon's revenues for the three months ended
September 30, 2015 increased to
$0.6 million from $0.4 million for the corresponding period in
2014, and for the nine months ended September 30, 2015 increased to $2.7 million from $1.4
million for the corresponding period in 2014.
Research and Development Expenses: Research and
development expenses for the three months ended September 30, 2015 decreased four percent to
$23.1 million from $24.1 million for the corresponding period in
2014. For the nine months ended September 30, 2015, research and development
expenses decreased seven percent to $64.7
million from $69.2 million for
the corresponding period in 2014.
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
September 30, 2015, the fair value of
the Symphony Icon purchase liability increased by $3.4 million as compared to a decrease of
$1.1 million in the corresponding
period in 2014. The increase in fair value of the Symphony
Icon purchase liability was $5.1
million and $0.5 million for
the nine months ended September 30,
2015 and 2014, respectively.
General and Administrative Expenses: General and
administrative expenses for the three months ended September 30, 2015 increased 17 percent to
$5.4 million from $4.6 million for the corresponding period in
2014, primarily due to increased costs in preparation for
commercialization of telotristat etiprate. For the nine months
ended September 30, 2015, general and
administrative expenses increased 13 percent to $17.4 million from $15.4
million for the corresponding period in 2014.
Impairment Loss on Buildings: In September 2014, Lexicon determined its buildings
and land should be classified as assets held for sale.
Lexicon recognized non-cash impairment losses on its buildings of
$2.3 million and $13.1 million for the nine months ended
September 30, 2015 and 2014,
respectively, as a result of writing down the buildings to the
estimated net selling price.
Consolidated Net Loss: Net loss for the three months
ended September 30, 2015 was
$35.3 million, or $0.34 per share, compared to a net loss of
$40.5 million, or $0.55 per share, in the corresponding period in
2014. Net loss for the nine months ended September 30, 2015 was $91.4 million, or $0.88 per share, compared to a net loss of
$97.4 million, or $1.32 per share, in the corresponding period in
2014. For the three and nine months ended September 30, 2015, net loss included non-cash,
stock-based compensation expense of $1.7
million and $5.4 million,
respectively. For the three and nine months ended
September 30, 2014, net loss included
non-cash, stock-based compensation expense of $1.5 million and $5.6
million, respectively.
Cash and Investments: As of September 30, 2015, Lexicon had $256.4 million in cash and investments, as
compared to $282.5 million as of
June 30, 2015 and $339.3 million as of December 31, 2014.
Reverse Stock Split: In May
2015, Lexicon completed a one-for-seven reverse stock
split. All references to common shares and per-share data for
all periods presented in this release have been adjusted to give
effect to this reverse stock split.
Lexicon Conference Call
Lexicon management will hold a conference call to discuss its
financial results and the collaboration with Sanofi at 8:00 a.m. Eastern Time on November 6, 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 76906861. 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 December 6, 2015.
About Lexicon
Lexicon is a fully integrated biopharmaceutical company that is
applying a unique approach to gene science, based on Nobel
Prize-winning technology, to discover and develop precise medicines
for patients with serious, chronic conditions. Through its
Genome5000™ program, Lexicon scientists have studied the role and
function of nearly 5,000 genes over the last 20 years and have
identified more than 100 protein targets with therapeutic potential
in a range of diseases. Through the precise targeting of these
proteins, Lexicon is pioneering the discovery and development of
innovative medicines to safely and effectively treat disease.
Lexicon has a pipeline of promising drug candidates in clinical and
pre-clinical development in oncology, diabetes and metabolism. For
additional information please visit. www.lexpharma.com.
Safe Harbor Statement
This press release contains "forward-looking statements,"
including statements relating to Lexicon's clinical development of
telotristat etiprate (LX1032) and sotagliflozin (LX4211) 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, 2014, 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)
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
|
(unaudited)
|
|
(unaudited)
|
Revenues:
|
|
|
|
|
|
|
|
|
Collaborative agreements
|
|
$ 505
|
|
$ 312
|
|
$ 2,635
|
|
$ 1,111
|
Subscription and license fees
|
|
61
|
|
107
|
|
99
|
|
261
|
Total revenues
|
|
566
|
|
419
|
|
2,734
|
|
1,372
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development, including stock-based compensation of $893, $797, $2,865 and $3,195,
respectively
|
|
23,111
|
|
24,108
|
|
64,745
|
|
69,248
|
Increase (decrease) in
fair value of Symphony Icon, Inc. purchase liability
|
|
3,404
|
|
(1,072)
|
|
5,145
|
|
518
|
General and
administrative, including stock-based compensation
of $779, $697, $2,548 and $2,389,
respectively
|
|
5,379
|
|
4,617
|
|
17,387
|
|
15,423
|
Impairment loss on
buildings
|
|
2,349
|
|
13,102
|
|
2,349
|
|
13,102
|
Total operating expenses
|
|
34,243
|
|
40,755
|
|
89,626
|
|
98,291
|
Loss from
operations
|
|
(33,677)
|
|
(40,336)
|
|
(86,892)
|
|
(96,919)
|
Interest
expense
|
|
(1,687)
|
|
(449)
|
|
(5,044)
|
|
(1,361)
|
Interest and other
income, net
|
|
82
|
|
287
|
|
504
|
|
919
|
Consolidated net
loss
|
|
$ (35,282)
|
|
$ (40,498)
|
|
$ (91,432)
|
|
$ (97,361)
|
|
|
|
|
|
|
|
|
|
Consolidated net loss
per common share, basic and diluted
|
|
$ (0.34)
|
|
$ (0.55)
|
|
$ (0.88)
|
|
$ (1.32)
|
|
|
|
|
|
|
|
|
|
Shares used in
computing net loss per common share, basic and diluted
|
|
103,616
|
|
73,542
|
|
103,580
|
|
73,494
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated
Balance Sheet Data
|
As of September
30,
|
|
As of December
31,
|
(In
thousands)
|
2015
|
|
2014
|
|
(unaudited)
|
|
|
Cash and
investments
|
$ 256,422
|
|
$ 339,339
|
Assets held for
sale
|
21,500
|
|
23,849
|
Property and
equipment, net
|
795
|
|
1,080
|
Goodwill
|
44,543
|
|
44,543
|
Other intangible
assets
|
53,357
|
|
53,557
|
Total
assets
|
391,140
|
|
471,376
|
Deferred
revenue
|
13,451
|
|
14,297
|
Current and long-term
debt
|
106,288
|
|
107,667
|
Other long-term
liabilities
|
23,520
|
|
23,535
|
Accumulated
deficit
|
(1,195,684)
|
|
(1,104,252)
|
Total stockholders'
equity
|
197,938
|
|
284,018
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/lexicon-pharmaceuticals-reports-3rd-quarter-financial-results-and-discusses-collaboration-with-sanofi-for-sotagliflozin-300173923.html
SOURCE Lexicon Pharmaceuticals, Inc.