Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported
financial results and provided a business update for the three
months ended September 30, 2018.
“In the third quarter, we and our collaborator,
Sanofi, have been working diligently with regulatory agencies to
make sotagliflozin available for patients with type 1 diabetes as
quickly as possible and we continue to make progress in growing
XERMELO for its current indication,” said Lonnel Coats,
Lexicon’s president and chief executive officer. “Our collaborator,
Ipsen, continues to gain approvals and market authorizations for
XERMELO in Europe. We are making good progress on our pipeline. By
end of year, we expect to start a clinical trial for telotristat
ethyl, the investigational form of XERMELO, in biliary tract cancer
as well as announce data for LX2761 in diabetes and LX9211, a
neuropathic pain candidate, in healthy volunteers.”
Third Quarter Product and Pipeline
Highlights
XERMELO® (telotristat ethyl) 250
mg
- XERMELO was approved in Australia in September for the
treatment of carcinoid syndrome diarrhea in combination with
somatostatin analog (SSA) therapy in adults inadequately controlled
by somatostatin analog (SSA) therapy.
- In the third quarter, Ipsen launched XERMELO in several
European countries including Sweden and Switzerland.
Sotagliflozin
- In September, clinical data for sotagliflozin were presented at
the European Association for the Study of Diabetes (EASD) 54th
annual meeting. Data from patient exit interviews from a
sotagliflozin Phase 3 study were also presented, reporting
meaningful improvements in patient reported outcomes.
Third Quarter 2018 Financial
Highlights
Revenues: Revenues for the
three months ended September 30, 2018 decreased to $6.9 million
from $26.9 million for the corresponding period in 2017, primarily
due to lower revenues recognized from the collaboration and license
agreement with Sanofi, partially offset by an increase in net
product revenues. Net product revenues for the three months ended
September 30, 2018 included $6.3 million from net sales of XERMELO
in the U.S., up 19% from the prior year quarter and 5% from the
second quarter of 2018.
Cost of Sales: Cost of sales
related to sales of XERMELO for each of the three months ended
September 30, 2018 and 2017 was $0.6 million.
Research and Development (R&D)
Expenses: Research and development expenses for the three
months ended September 30, 2018 decreased to $13.8 million from
$39.1 million for the corresponding period in 2017, primarily due
to lower external clinical development costs relating to
sotagliflozin.
Selling, General and Administrative
(SG&A) Expenses: Selling, general and administrative
expenses for the three months ended September 30, 2018 decreased to
$15.6 million from $16.7 million for the corresponding period in
2017, primarily due to decreased marketing costs.
Net Loss: Net loss for the
three months ended September 30, 2018 was $27.5 million, or $0.26
per share, compared to a net loss of $30.7 million, or $0.29 per
share, in the corresponding period in 2017. For the three months
ended September 30, 2018 and 2017, net loss included non-cash,
stock-based compensation expense of $2.9 million and $2.6
million, respectively.
Cash and Investments: As of
September 30, 2018, Lexicon had $187.3 million in cash and
investments, as compared to $310.8 million as of December 31,
2017.
Anticipated Near-Term
Milestones
- 4Q 2018 - Phase 1b data for LX2761 in type 2 diabetes
- 4Q 2018 - Phase 1a data for LX9211 (neuropathic pain candidate)
in healthy volunteers
- 4Q 2018 - Initiation of clinical development of telotristat
ethyl in biliary tract cancer
- March 22, 2019 – PDUFA date for sotagliflozin in type 1
diabetes
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 6394419. 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 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). A New Drug Application
and a Marketing Authorization Application for sotagliflozin are
currently under review at the U.S. Food and Drug Administration and
the European Medicines Agency, respectively, and the product has
not yet been approved for use in the U.S. or in Europe.
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 September 30, |
|
Nine Months Ended September 30, |
(In thousands, except
per share data) |
|
2018 |
|
2017 |
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
(Unaudited) |
Revenues: |
|
|
|
|
|
|
|
|
Net product revenue |
|
$ |
6,286 |
|
|
$ |
5,830 |
|
|
$ |
19,062 |
|
|
$ |
10,443 |
|
Collaborative agreements |
|
|
446 |
|
|
|
21,112 |
|
|
|
26,470 |
|
|
|
46,781 |
|
Royalties
and other revenue |
|
|
124 |
|
|
|
- |
|
|
|
284 |
|
|
|
64 |
|
Total
revenues |
|
|
6,856 |
|
|
|
26,942 |
|
|
|
45,816 |
|
|
|
57,288 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Cost of
sales (including finite-lived intangible |
|
|
|
|
|
|
|
|
asset
amortization) |
|
|
551 |
|
|
|
599 |
|
|
|
1,922 |
|
|
|
1,361 |
|
Research
and development, including stock-based |
|
|
|
|
|
|
|
|
compensation of $1,472, $1,345, $4,522 and $3,698,
respectively |
|
|
13,769 |
|
|
|
39,137 |
|
|
|
88,141 |
|
|
|
109,653 |
|
Increase
in fair value of Symphony Icon purchase liability |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
2,101 |
|
Selling,
general and administrative, including stock-based |
|
|
|
|
|
|
|
|
compensation of $1,405, $1,235, $4,327 and $3,516,
respectively |
|
|
15,579 |
|
|
|
16,724 |
|
|
|
47,191 |
|
|
|
50,069 |
|
Total
operating expenses |
|
|
29,899 |
|
|
|
56,460 |
|
|
|
137,254 |
|
|
|
163,184 |
|
Loss from
operations |
|
|
(23,043 |
) |
|
|
(29,518 |
) |
|
|
(91,438 |
) |
|
|
(105,896 |
) |
Interest expense |
|
|
(5,252 |
) |
|
|
(1,619 |
) |
|
|
(15,553 |
) |
|
|
(4,821 |
) |
Interest and other
income, net |
|
|
783 |
|
|
|
415 |
|
|
|
2,698 |
|
|
|
1,393 |
|
Net loss
before income taxes |
|
|
(27,512 |
) |
|
|
(30,722 |
) |
|
|
(104,293 |
) |
|
|
(109,324 |
) |
Income
tax benefit |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
8,652 |
|
Net loss |
|
$ |
(27,512 |
) |
|
$ |
(30,722 |
) |
|
$ |
(104,293 |
) |
|
$ |
(100,672 |
) |
|
|
|
|
|
|
|
|
|
Net loss
per common share, basic and diluted |
|
$ |
(0.26 |
) |
|
$ |
(0.29 |
) |
|
$ |
(0.99 |
) |
|
$ |
(0.96 |
) |
|
|
|
|
|
|
|
|
|
Shares used in
computing net loss per common share, basic |
|
|
|
|
|
|
|
|
and
diluted |
|
|
105,881 |
|
|
|
105,582 |
|
|
|
105,800 |
|
|
|
105,119 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of |
|
As of |
Consolidated
Balance Sheet Data |
|
|
|
|
|
September 30, 2018 |
|
December 31, 2017 |
(In thousands) |
|
|
|
|
|
(Unaudited) |
|
|
Cash and
investments |
|
|
|
|
|
$ |
187,297 |
|
|
$ |
310,788 |
|
Property
and equipment, net |
|
|
|
|
|
|
16,299 |
|
|
|
17,687 |
|
Goodwill |
|
|
|
|
|
|
44,543 |
|
|
|
44,543 |
|
Other
intangible assets |
|
|
|
|
|
|
50,561 |
|
|
|
51,885 |
|
Total
assets |
|
|
|
|
|
|
310,192 |
|
|
|
436,539 |
|
Deferred
revenue |
|
|
|
|
|
|
23,108 |
|
|
|
62,527 |
|
Current
and long-term debt |
|
|
|
|
|
|
244,945 |
|
|
|
245,670 |
|
Accumulated deficit |
|
|
|
|
|
|
(1,471,485 |
) |
|
|
(1,381,404 |
) |
Total
stockholders' equity |
|
|
|
|
|
|
(29,401 |
) |
|
|
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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