THE WOODLANDS, Texas,
Nov. 8, 2017 /PRNewswire/ -- Lexicon Pharmaceuticals,
Inc. (Nasdaq: LXRX), today reported financial results for the three
months ended September 30, 2017 and
provided an overview of key milestones for the company's commercial
product, XERMELO® (telotristat ethyl), and its pipeline
drug candidates.
"We had a very busy and productive third quarter with strong
operational performance across all aspects of our business,
including the achievement of several important milestones. We made
significant progress in growing our prescriber base and providing
access to XERMELO. This momentum, along with the launch of XERMELO
in the U.K. and Germany, supports
our confidence in the long-term outlook on the commercial
business," said Lonnel Coats,
Lexicon's president and chief executive officer. "XERMELO is a
significant franchise for us, and we are extremely excited about
exploring the use of telotristat ethyl in additional therapeutic
indications where the role of serotonin inhibition has shown
preclinical promise. In parallel, we and Sanofi are making good
progress towards advancing sotagliflozin to market in type 1
diabetes. Lastly, we continue to advance our earlier-stage product
candidates in areas we believe will create substantial long-term
value for the company."
Third Quarter 2017 Product and Pipeline Progress
XERMELO (telotristat ethyl) 250 mg
- In September, Ipsen, Lexicon's collaborator, received marketing
approval from the European Commission for the treatment of
carcinoid syndrome diarrhea in combination with somatostatin analog
therapy, allowing for the marketing of XERMELO for such indication
in all 28 member states of the European Union, Norway and Iceland.
- In September, data from four posters of XERMELO were
highlighted at the European Society of Medical Oncology
(ESMO).
Sotagliflozin
- In July, Lexicon exercised its option under its collaboration
and license agreement with Sanofi to co-promote sotagliflozin for
the treatment of type 1 diabetes in the U.S.
- In August, Sanofi initiated the following Phase 3 sotagliflozin
studies in type 2 diabetes:
-
- Safety and efficacy study of sotagliflozin on glucose control
in patients with type 2 diabetes, moderate impairment of kidney
function, and inadequate blood sugar control (NCT03242252)
- A study to evaluate safety and effects of sotagliflozin dose 1
and dose 2 on glucose control in patients with type 2 diabetes,
severe impairment of kidney function and inadequate blood sugar
control (NCT03242018)
- In September, Sanofi initiated the following Phase 3
sotagliflozin study in type 2 diabetes:
-
- Efficacy and safety of sotagliflozin versus placebo in subjects
with type 2 diabetes mellitus who have inadequate glycemic control
while taking insulin alone or with other oral antidiabetic agents
(NCT03285594)
- In September, Lexicon announced statistically significant
52-week A1C benefit data and achievement of all secondary endpoints
in the pivotal Phase 3 inTandem2 study of sotagliflozin.
- In September, Lexicon reported statistically significant pooled
continuous glucose monitoring (CGM) data from the pivotal Phase 3
inTandem1 and inTandem2 studies of sotagliflozin.
- In September, the New England Journal of Medicine published
data from the Phase 3 inTandem3 study of sotagliflozin in patients
with type 1 diabetes in conjunction with presentation of these data
at the European Association for the Study of Diabetes (EASD)
53rd annual meeting.
LX2761
- Lexicon continued to progress Phase 1 clinical trials of
LX2761, an orally-administered drug candidate targeted to the
inhibition of SGLT1 in the gastrointestinal tract that is being
developed for diabetes.
LX9211
- Lexicon filed an investigational new drug (IND) application and
began a Phase 1 study of LX9211, an orally-administered
selective inhibitor of AAK1 (adapter-associated kinase 1) in
development for neuropathic pain.
Third Quarter 2017 Financial Highlights
Revenues: Revenues for the three months ended
September 30, 2017 decreased to
$26.9 million from $27.7 million for the corresponding period in
2016, primarily due to lower revenues recognized from the
collaboration and license agreement with Sanofi, partially offset
by $5.8 million in net product
revenues. Net product revenues for the three months ended
September 30, 2017 included
$5.3 million and $0.5 million, respectively, from the sale of
XERMELO in the U.S. and sale of bulk tablets of telotristat ethyl
to Ipsen. Revenue from collaborative agreements included a
$5.1 million milestone from Ipsen for
approval of XERMELO in Europe.
Cost of Sales: Lexicon had cost of sales related to sales
of XERMELO of $0.6 million for the
three months ended September 30,
2017, of which $0.4 million
consisted of amortization of intangible assets.
Research and Development Expenses: Research and
development expenses for the three months ended September 30, 2017 decreased 26 percent to
$39.1 million from $52.5 million for the corresponding period in
2016, primarily due to decreases in external clinical development
costs relating to sotagliflozin.
Selling, General and Administrative Expenses: Selling,
general and administrative expenses for the three months ended
September 30, 2017 increased 36
percent to $16.7 million from
$12.3 million for the corresponding
period in 2016, primarily due to increased costs associated with
the commercial launch of XERMELO.
Consolidated Net Loss: Net loss for the three months
ended September 30, 2017 was
$30.7 million, or $0.29 per share, compared to a net loss of
$36.0 million, or $0.35 per share, in the corresponding period in
2016. For the three months ended September
30, 2017, net loss included non-cash, stock-based
compensation expense of $2.6 million. For the three months ended
September 30, 2016, net loss included
non-cash, stock-based compensation expense of $1.9 million.
Cash and Investments: As of September 30, 2017, Lexicon had $196.8 million in cash and investments, as
compared to $346.5 million as of
December 31, 2016.
Anticipated Upcoming Milestones
- 2H 2017 – Initiation of several additional Phase 3
sotagliflozin studies in type 2 diabetes by Sanofi
- 1H 2018 – U.S. and EU regulatory filings for sotagliflozin in
type 1 diabetes by Sanofi
- 1H 2018 – Phase 1b data for LX2761 in patients with type 2
diabetes
- 2018 – Launch of XERMELO in additional European countries
- 2018 – Phase 1 data for LX9211 in neuropathic pain
- 2018 – Life cycle management studies of XERMELO in fibrotic
disease and cancer
Conference Call and Webcast Information
Lexicon management will hold a live conference call and webcast
today at 8:00 am EST / 7:00 am CST to review its financial and operating
results and to provide a general business update. The dial-in
number for the conference call is 888-645-5785 (U.S./Canada) or 970-300-1531 (international). The
conference ID for all callers is 9047069. The live webcast and
replay may be accessed by visiting Lexicon's website at
www.lexpharma.com/investors. An archived version of the webcast
will be available on the website for 14 days.
About XERMELO (telotristat ethyl)
Discovered using Lexicon's unique approach to gene science,
XERMELO (telostristat ethyl) is the first and only approved oral
therapy for carcinoid syndrome diarrhea in combination with
somatostatin analog (SSA) therapy in adults inadequately controlled
by SSAs. XERMELO targets tryptophan hydroxylase, an enzyme that
mediates the excess serotonin production within metastatic
neuroendocrine tumor (mNET) cells. Lexicon has built the in-house
capability and infrastructure to launch and market XERMELO in the
U.S., where it retains all commercialization rights. Lexicon also
retains rights to market XERMELO in Japan. Lexicon has established a license and
collaboration agreement with Ipsen to commercialize XERMELO in
Europe and other countries outside
of U.S. and Japan.
XERMELO was approved by the U.S. Food and Drug Administration on
February 28, 2017 and by the European
Commission on September 19, 2017 for
the treatment of carcinoid syndrome diarrhea in combination with
SSA therapy in adults inadequately controlled by SSA therapy.
Carcinoid syndrome is a rare condition that occurs in patients
living with metastatic NETs (mNETs) and is characterized by
frequent and debilitating diarrhea. XERMELO targets the
overproduction of serotonin inside mNET cells, providing a new
treatment option for patients suffering from carcinoid syndrome
diarrhea.
XERMELO (telotristat ethyl) Important Safety
Information
- Warnings and Precautions: XERMELO may cause
constipation, which can be serious. Monitor for signs and symptoms
of constipation and/or severe, persistent, or worsening abdominal
pain in patients taking XERMELO. Discontinue XERMELO if severe
constipation or severe, persistent, or worsening abdominal pain
develops.
- Adverse Reactions: The most common adverse
reactions (≥5%) include nausea, headache, increased
gamma-glutamyl-transferase, depression, flatulence, decreased
appetite, peripheral edema, and pyrexia.
- Drug Interactions: If necessary, consider
increasing the dose of concomitant CYP3A4 substrates, as XERMELO
may decrease their systemic exposure. If combination treatment with
XERMELO and short-acting octreotide is needed, administer
short-acting octreotide at least 30 minutes after administering
XERMELO.
For more information about XERMELO, see Full Prescribing
Information at www.xermelo.com.
About Lexicon Pharmaceuticals
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 significant
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. In addition to its first commercial product,
XERMELO® (telotristat ethyl) for carcinoid
syndrome diarrhea, Lexicon has a pipeline of promising drug
candidates in clinical and pre-clinical development in diabetes and
metabolism and neuropathic pain. For additional information please
visit www.lexpharma.com.
Safe Harbor Statement
This press release contains "forward-looking statements,"
including statements relating to Lexicon's long-term outlook on its
commercial business, including commercialization of XERMELO
(telotristat ethyl), the clinical development of and regulatory
filings for sotagliflozin, LX2761 and LX9211 and the
potential therapeutic and commercial potential of XERMELO,
sotagliflozin, LX2761 and LX9211. In addition, this press
release also contains forward looking statements relating to
Lexicon's growth and future operating results, discovery,
development and commercialization 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 Lexicon's ability to meet its capital
requirements, successfully commercialize XERMELO, successfully
conduct preclinical and clinical development and obtain necessary
regulatory approvals of sotagliflozin, LX2761 and LX9211 and its
other potential drug candidates on its anticipated timelines,
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. Any of these risks, uncertainties and other factors 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,
2016, 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.
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Selected Financial
Data
|
|
|
|
|
|
|
|
|
|
|
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Consolidated
Statements of Operations Data
|
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Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
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(In thousands,
except per share data)
|
|
2017
|
|
2016
|
|
2017
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2016
|
|
|
|
(unaudited)
|
|
(unaudited)
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
Net product
revenue
|
|
$
5,830
|
|
$
-
|
|
$
10,443
|
|
$
-
|
|
Collaborative
agreements
|
|
21,112
|
|
27,686
|
|
46,781
|
|
60,181
|
|
Subscription and
license fees
|
|
-
|
|
31
|
|
64
|
|
119
|
|
Total
revenues
|
|
26,942
|
|
27,717
|
|
57,288
|
|
60,300
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Cost of sales
(including finite-lived intangible asset amortization)
|
|
599
|
|
-
|
|
1,361
|
|
-
|
|
Research and
development, including stock-based compensation
|
|
39,137
|
|
52,533
|
|
109,653
|
|
137,751
|
|
Increase (decrease)
in fair value of Symphony Icon purchase liability
|
|
-
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|
(2,146)
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|
2,101
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(703)
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|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative, including stock-based compensation
|
|
16,724
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|
12,263
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|
50,069
|
|
29,077
|
|
Total operating
expenses
|
|
56,460
|
|
62,650
|
|
163,184
|
|
166,125
|
|
Loss from
operations
|
|
(29,518)
|
|
(34,933)
|
|
(105,896)
|
|
(105,825)
|
|
Interest
expense
|
|
(1,619)
|
|
(1,646)
|
|
(4,821)
|
|
(4,933)
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Interest and other
income, net
|
|
415
|
|
564
|
|
1,393
|
|
1,748
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Net loss before
income taxes
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|
(30,722)
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|
(36,015)
|
|
(109,324)
|
|
(109,010)
|
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Income tax
benefit
|
|
-
|
|
-
|
|
8,652
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|
-
|
|
Net loss
|
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$ (30,722)
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|
$ (36,015)
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|
$
(100,672)
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|
$
(109,010)
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|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
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Net loss per common
share, basic and diluted
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$
(0.29)
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|
$
(0.35)
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$
(0.96)
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|
$
(1.05)
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|
|
|
|
|
|
|
|
|
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Shares used in
computing net loss per common share, basic and diluted
|
|
105,582
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|
103,885
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|
105,119
|
|
103,799
|
|
|
|
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Consolidated
Balance Sheet Data
|
|
September 30,
2017
|
|
December 31,
2016
|
(In
thousands)
|
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(Unaudited)
|
|
|
|
|
|
|
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Cash and
investments
|
|
$
196,817
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|
$
346,504
|
Property and
equipment, net
|
|
18,167
|
|
19,390
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Goodwill
|
|
44,543
|
|
44,543
|
Other intangible
assets
|
|
52,327
|
|
53,357
|
Total
assets
|
|
329,487
|
|
475,625
|
Deferred
revenue
|
|
75,283
|
|
112,306
|
Current and long-term
debt
|
|
100,145
|
|
101,447
|
Accumulated
deficit
|
|
(1,353,026)
|
|
(1,250,363)
|
Total stockholders'
equity
|
|
78,376
|
|
157,401
|
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SOURCE Lexicon Pharmaceuticals, Inc.