XERMELO® (telotristat ethyl)
Quarterly U.S. Net Sales of $6.0 Million, Up 65% from Prior Year
Quarter and 11% Quarter-Over-Quarter
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported
financial results and provided a business update for the three
months ended June 30, 2018.
“We continue to make progress across our
portfolio while maintaining good financial discipline,” said Lonnel
Coats, Lexicon’s president and chief executive officer. “In the
second quarter, we experienced significant momentum around our
sotagliflozin program with the FDA’s acceptance of our collaborator
Sanofi’s NDA filing for type 1 diabetes and the recent publications
of the pivotal sotagliflozin studies in Diabetes Care. In addition,
Sanofi is making excellent progress in enrolling the Phase 3
studies in the type 2 diabetes program. In the second half of the
year, we anticipate continued advancement of our pipeline, which we
believe will create long-term value for the company.”
Second Quarter Product and Pipeline
Highlights
XERMELO (telotristat ethyl) 250
mg
- Favorable data on body weight from the randomized,
double-blind, placebo-controlled Phase 3 TELESTAR (Telotristat
Etiprate for Somatostatin Analog Not Adequately Controlled
Carcinoid Syndrome) study were published in Clinical Therapeutics
in May.
Sotagliflozin
- In May, the U.S. Food and Drug Administration (FDA) accepted
Lexicon collaborator Sanofi’s New Drug Application (NDA) for
sotagliflozin for use in combination with insulin therapy to
improve glycemic control in adults with type 1 diabetes mellitus
with a PDUFA date of March 22, 2019.
- Positive 52-week inTandem1 and inTandem2 data were presented at
the 78th Scientific Sessions of the American Diabetes Association
(ADA) and published in Diabetes Care in June.
Second Quarter 2018 Financial
Highlights
Revenues: Revenues for the
three months ended June 30, 2018 increased to $13.8 million from
$12.1 million for the corresponding period in 2017, primarily due
to an increase in net product revenues, partially offset by lower
revenues recognized from the collaboration and license agreement
with Sanofi. Net product revenues for the three months ended June
30, 2018 included $6.0 million from net sales of XERMELO in the
U.S., up 65% from the prior year quarter and 11% from the first
quarter of 2018, and $1.3 million from the sale of bulk tablets of
XERMELO to Ipsen.
Cost of Sales: Cost of sales
related to sales of XERMELO for the three months ended June 30,
2018 increased to $0.8 million from $0.5 million for the
corresponding period in 2017.
Research and Development (R&D)
Expenses: Research and development expenses for the three
months ended June 30, 2018 were $26.6 million compared to $26.9
million for the corresponding period in 2017.
Selling, General and Administrative
(SG&A) Expenses: Selling, general and administrative
expenses for three months ended June 30, 2018 decreased to $16.8
million from $18.5 million for the corresponding period in 2017,
primarily due to decreased marketing costs.
Net Loss: Net loss for the
three months ended June 30, 2018 was $34.7 million, or $0.33 per
share, compared to a net loss of $35.1 million, or $0.33 per share,
in the corresponding period in 2017. For the three months ended
June 30, 2018 and 2017, net loss included non-cash, stock-based
compensation expense of $2.9 million and $2.4 million,
respectively.
Cash and Investments: As of
June 30, 2018, Lexicon had $209.7 million in cash and investments,
as compared to $310.8 million as of December 31, 2017.
Anticipated Upcoming Milestones in 2H
2018
- Sotagliflozin data presentations at the 54th Annual Meeting of
the European Association for the Study of Diabetes (EASD; October
1-5, 2018; Berlin, Germany)
- Phase 1b data for LX2761 in type 2 diabetes
- Initiation of clinical development of telotristat ethyl
in oncology
- Phase 1a data for LX9211 (neuropathic pain candidate) in
healthy volunteers
- Manuscript publications for XERMELO and sotagliflozin
- Launch of XERMELO by Ipsen in additional European
countries
Conference Call and Webcast
Information
Lexicon management will hold a live conference
call and webcast today at 8:00 am EDT / 7:00 am CDT 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 8776903. 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 (telotristat 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 an additional 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 Sotagliflozin
Discovered using Lexicon’s unique approach to
gene science, sotagliflozin is an investigational oral dual
inhibitor of two proteins responsible for glucose regulation known
as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2).
SGLT1 is responsible for glucose absorption in the gastrointestinal
tract, and SGLT2 is responsible for glucose reabsorption by the
kidney.
Lexicon entered into a collaboration and license
agreement with Sanofi in November 2015 under which Lexicon granted
Sanofi an exclusive, worldwide (excluding Japan), royalty-bearing
right and license to develop, manufacture and commercialize
sotagliflozin. Lexicon is responsible for all clinical development
activities relating to type 1 diabetes and has exercised an
exclusive option to co-promote and have a significant role, in
collaboration with Sanofi, in the commercialization of
sotagliflozin for the treatment of type 1 diabetes in the U.S.
Sanofi is responsible for all clinical development and
commercialization of sotagliflozin for the treatment of type 2
diabetes worldwide (excluding Japan) and is solely responsible for
the commercialization of sotagliflozin for the treatment of type 1
diabetes outside the U.S. (excluding Japan).
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
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 business, including the commercialization of XERMELO
(telotristat ethyl), the clinical development of, the regulatory
filings for, 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
obtain regulatory approvals of sotagliflozin and successfully
conduct preclinical and clinical development and obtain necessary
regulatory approvals of LX2761, 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, 2017, 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 June 30, |
|
Six Months Ended June 30, |
|
|
(In thousands, except
per share data) |
|
2018 |
|
2017 |
|
2018 |
|
2017 |
|
|
|
|
(Unaudited) |
|
(Unaudited) |
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
Net
product revenue |
|
$ |
7,316 |
|
|
$ |
3,892 |
|
|
$ |
12,776 |
|
|
$ |
4,613 |
|
|
|
Collaborative agreements |
|
|
6,359 |
|
|
|
8,104 |
|
|
|
26,024 |
|
|
|
25,669 |
|
|
|
Royalties
and other revenue |
|
|
78 |
|
|
|
57 |
|
|
|
160 |
|
|
|
64 |
|
|
|
Total
revenues |
|
|
13,753 |
|
|
|
12,053 |
|
|
|
38,960 |
|
|
|
30,346 |
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
Cost of
sales (including finite-lived intangible |
|
|
|
|
|
|
|
|
|
|
asset amortization) |
|
|
838 |
|
|
|
537 |
|
|
|
1,371 |
|
|
|
762 |
|
|
|
Research
and development, including stock-based |
|
|
|
|
|
|
|
|
|
|
compensation of $1,395, $1,169, $3,050 and $2,353,
respectively |
|
|
26,589 |
|
|
|
26,934 |
|
|
|
74,372 |
|
|
|
70,515 |
|
|
|
Increase
in fair value of Symphony Icon purchase liability |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
2,101 |
|
|
|
Selling,
general and administrative, including stock-based |
|
|
|
|
|
|
|
|
|
|
compensation of $1,503, $1,234, $2,922 and $2,281,
respectively |
|
|
16,755 |
|
|
|
18,475 |
|
|
|
31,612 |
|
|
|
33,346 |
|
|
|
Total
operating expenses |
|
|
44,182 |
|
|
|
45,946 |
|
|
|
107,355 |
|
|
|
106,724 |
|
|
|
Loss from
operations |
|
|
(30,429 |
) |
|
|
(33,893 |
) |
|
|
(68,395 |
) |
|
|
(76,378 |
) |
|
|
Interest expense |
|
|
(5,187 |
) |
|
|
(1,614 |
) |
|
|
(10,301 |
) |
|
|
(3,202 |
) |
|
|
Interest and other
income, net |
|
|
910 |
|
|
|
448 |
|
|
|
1,915 |
|
|
|
978 |
|
|
|
Net loss
before income taxes |
|
|
(34,706 |
) |
|
|
(35,059 |
) |
|
|
(76,781 |
) |
|
|
(78,602 |
) |
|
|
Income
tax benefit |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
8,652 |
|
|
|
Net loss |
|
$ |
(34,706 |
) |
|
$ |
(35,059 |
) |
|
$ |
(76,781 |
) |
|
$ |
(69,950 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
per common share, basic and diluted |
|
$ |
(0.33 |
) |
|
$ |
(0.33 |
) |
|
$ |
(0.73 |
) |
|
$ |
(0.67 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in
computing net loss |
|
|
|
|
|
|
|
|
|
|
per
common share, basic and diluted |
|
|
105,848 |
|
|
|
105,300 |
|
|
|
105,758 |
|
|
|
104,883 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As
of |
|
As of |
|
|
Consolidated
Balance Sheet Data |
|
|
|
|
|
June 30, 2018 |
|
December 31,
2017 |
|
|
(In thousands) |
|
|
|
|
|
(Unaudited) |
|
|
|
|
Cash and
investments |
|
|
|
|
|
$ |
209,689 |
|
|
$ |
310,788 |
|
|
|
Property and
equipment, net |
|
|
|
|
|
|
16,772 |
|
|
|
17,687 |
|
|
|
Goodwill |
|
|
|
|
|
|
44,543 |
|
|
|
44,543 |
|
|
|
Other intangible
assets |
|
|
|
|
|
|
51,002 |
|
|
|
51,885 |
|
|
|
Total
assets |
|
|
|
|
|
|
332,937 |
|
|
|
436,539 |
|
|
|
Deferred
revenue |
|
|
|
|
|
|
23,319 |
|
|
|
62,527 |
|
|
|
Current and
long-term debt |
|
|
|
|
|
|
245,094 |
|
|
|
245,670 |
|
|
|
Accumulated
deficit |
|
|
|
|
|
|
(1,443,973 |
) |
|
|
(1,381,404 |
) |
|
|
Total
stockholders' equity |
|
|
|
|
|
|
(5,071 |
) |
|
|
52,102 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For Investor Inquiries:
Kimberly Lee, D.O.Head of Investor Relations and
Corporate StrategyLexicon Pharmaceuticals(281)
863-3383klee@lexpharma.com
For Media Inquiries:
Chas SchultzExecutive Director, Corporate
Communications and Patient AdvocacyLexicon Pharmaceuticals(281)
863-3421cschultz@lexpharma.com
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