XERMELO® (telotristat ethyl)
Quarterly U.S. Net Sales of $5.4 Million
Lexicon Pharmaceuticals, Inc. (Nasdaq:LXRX), today reported
financial results for the three months ended March 31, 2018 and
highlighted progress with the company’s first commercial product,
XERMELO® (telotristat ethyl), its pipeline drug candidates and its
overall business. The company will conduct a conference call and
webcast today at 8:00 am EDT / 7:00 am CDT to discuss the financial
results and to provide a business update.
“Although we are treating more people affected
with carcinoid syndrome diarrhea than ever before, we still have
much work to do,” said Lonnel Coats, Lexicon’s president and chief
executive officer. “We continue to position the company for future
growth and to build long-term sustainable value for shareholders.
As such, we are excited about exploring the investigational use of
telotristat ethyl in oncology indications this year. For
sotagliflozin, we are a step closer to making the therapy available
to people with type 1 diabetes, with the recent regulatory
submissions in the U.S. and in Europe and the European Medicines
Agency’s acceptance of the filing in Europe. Finally, we look
forward to reporting clinical data later this year from our
earlier-stage product candidates, LX2761 and LX9211, in diabetes
and neuropathic pain, respectively, which we believe will create
long-term value for the company.”
First Quarter Product and Pipeline
Highlights
XERMELO (telotristat ethyl) 250
mg
- Data from a poster highlighting time to sustained improvement
in bowel movement frequency with XERMELO were presented at the 2018
American Society of Clinical Oncology Gastrointestinal Cancers
Symposium (ASCO GI; San Francisco) in January.
Sotagliflozin
- Lexicon’s collaborator Sanofi submitted a New Drug Application
(NDA) to the U.S. Food and Drug Administration (FDA) in March for
sotagliflozin, for use in combination with insulin therapy to
improve glycemic control in adults with type 1 diabetes
mellitus.
- Sanofi submitted a Marketing Authorization Application (MAA) to
the European Medicines Agency (EMA) in March for sotagliflozin, for
use in combination with insulin therapy to improve glycemic control
in adults with type 1 diabetes mellitus, and the review of the MAA
under the Centralized Procedure began on March 29.
LX2761
- A Phase 1b clinical trial of LX2761, an orally administered
drug candidate selectively targeted to inhibit SGLT1
(sodium-glucose cotransporter type 1) in the gastrointestinal
tract, remains ongoing in people with type 2 diabetes.
LX9211
- A Phase 1a clinical trial of LX9211, an orally-administered
drug candidate selectively targeted to inhibit AAK1
(adapter-associated kinase 1), remains ongoing in healthy
volunteers.
First Quarter 2018 Financial
Highlights
Revenues: Revenues for the
first quarter of 2018 increased 38% to $25.2 million from $18.3
million for the corresponding period in 2017, primarily due to an
increase in net product revenues recognized from the sale of
XERMELO in the U.S. to $5.4 million from $0.7 million and increased
revenue from collaborative agreements.
Cost of Sales: Cost of sales
related to sales of XERMELO for the first quarter of 2018 increased
137% to $0.5 million from $0.2 million for the corresponding period
in 2017.
Research and Development (R&D)
Expenses: Research and development expenses increased 10%
to $47.8 million for the first quarter of 2018 from $43.6 million
for the corresponding period in 2017, primarily due to higher
external clinical development expenses relating in substantial part
to development of sotagliflozin in type 2 diabetes and professional
and consulting fees related to sotagliflozin NDA preparation.
Selling, General and Administrative
(SG&A) Expenses: Selling, general and administrative
expenses for the first quarter of 2018 were flat year-over-year at
$14.9 million.
Consolidated Net Loss: Net loss
for the first quarter of 2018 was $42.1 million, or $0.40 per
share, compared to a net loss of $34.9 million, or $0.33 per share,
in the corresponding period in 2017. For the first quarter 2018 and
2017, net loss included non-cash, stock-based compensation expense
of $3.1 million and $2.2 million, respectively.
Cash and Investments: As of
March 31, 2018, Lexicon had $262.3 million in cash and investments,
as compared to $310.8 million as of December 31, 2017.
Anticipated Upcoming
Milestones
- 2Q 2018 – Initiation of additional Phase 3 sotagliflozin study
in type 2 diabetes by Sanofi
- 3Q 2018 – Phase 1b data for LX2761 in type 2 diabetes
- June 2018 – Sotagliflozin data presentations at the American
Diabetes Association 78th Scientific Sessions (ADA; June 22-26,
2018; Orlando, FL)
- October 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)
- 2H 2018 – Initiation of clinical studies for telotristat ethyl
in neuroendocrine tumors and biliary tract cancers
- 2H 2018 – Phase 1a data for LX9211 in neuropathic pain
- 2018 – Manuscript publications for XERMELO and
sotagliflozin
- 2018 – 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 3191269. 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 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 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 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 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 March 31, |
(In thousands, except
per share data) |
|
2018 |
|
2017 |
|
|
(Unaudited) |
Revenues: |
|
|
|
|
Net
product revenue |
|
$ |
5,460 |
|
|
$ |
721 |
|
Collaborative agreements |
|
|
19,665 |
|
|
|
17,565 |
|
Royalties
and other revenue |
|
|
82 |
|
|
|
7 |
|
Total
revenues |
|
|
25,207 |
|
|
|
18,293 |
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
Cost of
sales (including finite-lived intangible asset amortization) |
|
|
533 |
|
|
|
225 |
|
|
|
|
|
|
|
|
|
|
Research
and development, including stock-based compensation |
|
|
|
|
of $1,655
and $1,184, respectively |
|
|
47,783 |
|
|
|
43,581 |
|
|
|
|
|
|
|
|
|
|
Increase
in fair value of Symphony Icon purchase liability |
|
|
- |
|
|
|
2,101 |
|
|
|
|
|
|
Selling,
general and administrative, including stock-based compensation |
|
|
|
|
of $1,419
and $1,047, respectively |
|
|
14,857 |
|
|
|
14,871 |
|
Total
operating expenses |
|
|
63,173 |
|
|
|
60,778 |
|
Loss from
operations |
|
|
(37,966 |
) |
|
|
(42,485 |
) |
Interest expense |
|
|
(5,114 |
) |
|
|
(1,588 |
) |
Interest and other
income, net |
|
|
1,005 |
|
|
|
530 |
|
Net loss
before income taxes |
|
|
(42,075 |
) |
|
|
(43,543 |
) |
Income
tax benefit |
|
|
- |
|
|
|
8,652 |
|
Consolidated net
loss |
|
$ |
(42,075 |
) |
|
$ |
(34,891 |
) |
|
|
|
|
|
|
|
|
|
|
Consolidated net loss per common share, basic and diluted |
|
$ |
(0.40 |
) |
|
$ |
(0.33 |
) |
|
|
|
|
|
Shares used in
computing consolidated net loss |
|
|
|
|
per
common share, basic and diluted |
|
|
105,668 |
|
|
|
104,461 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated
Balance Sheet Data |
|
As of March 31,2018 |
|
As of December 31,2017 |
(In thousands) |
|
(Unaudited) |
|
|
|
|
|
|
|
Cash and
investments |
|
$ |
262,272 |
|
|
$ |
310,788 |
|
Property
and equipment, net |
|
|
17,244 |
|
|
|
17,687 |
|
Goodwill |
|
|
44,543 |
|
|
|
44,543 |
|
Other
intangible assets |
|
|
51,444 |
|
|
|
51,885 |
|
Total
assets |
|
|
386,813 |
|
|
|
436,539 |
|
Deferred
revenue |
|
|
29,514 |
|
|
|
62,527 |
|
Current
and long-term debt |
|
|
245,396 |
|
|
|
245,670 |
|
Accumulated deficit |
|
|
(1,409,267 |
) |
|
|
(1,381,404 |
) |
Total
stockholders' equity |
|
|
26,194 |
|
|
|
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
Lexicon Pharmaceuticals (NASDAQ:LXRX)
Historical Stock Chart
From Jun 2024 to Jul 2024
Lexicon Pharmaceuticals (NASDAQ:LXRX)
Historical Stock Chart
From Jul 2023 to Jul 2024