Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported
financial results and provided a business update for the three
months ended March 31, 2019.
“XERMELO net sales grew more than 20% in the
first quarter of 2019 versus the same period in 2018. We advanced
the telotristat ethyl Phase 2 program for biliary tract cancer,
with the first patient dosed, and we continued making progress in
advancing LX9211, a candidate for neuropathic pain,” said Lonnel
Coats, Lexicon’s president and chief executive officer. “We are
pleased with the recent approval of Zynquista in type 1 diabetes in
Europe, which represents the second product originating from our
own laboratories to be approved in a major region in a span of only
26 months. In the U.S., we and our collaborator, Sanofi, will be
working with the FDA to better understand sotagliflozin’s potential
pathway to approval in type 1 diabetes. Lastly, we look forward to
topline results from the first of several Phase 3 studies of
sotagliflozin in type 2 diabetes. We will provide updates on our
progress throughout the year.”
First Quarter Product and Pipeline
Highlights
XERMELO® (telotristat
ethyl)
- XERMELO U.S. net sales were $6.7
million in the first quarter of 2019.
- The first patient was dosed in the
Telotristat Ethyl for
Advanced Biliary Tract
Cancer, or TELE-ABC, study, a Phase 2a clinical
study of telotristat ethyl in patients with biliary tract
cancer.
- Data from a patient-reported survey
demonstrating improvement in carcinoid syndrome symptoms after
initiation of XERMELO therapy in the real world were presented at
the 16th Annual European Neuroendocrine Tumor Society Conference
(ENETS).
Zynquista™ (sotagliflozin)
- The U.S. Food and Drug
Administration (FDA) issued a complete response letter (CRL) for
sotagliflozin for the treatment of adults with type 1 diabetes in
combination with insulin in March. The CRL followed the
Endocrinologic and Metabolic Drugs Advisory Committee’s eight to
eight vote in January on the question of whether the overall
benefits of sotagliflozin outweighed the risks to support
approval.
- In March, the European Medicines
Agency’s Committee for Medicinal Products for Human Use (CHMP)
adopted a positive opinion on the Marketing Authorization of
Zynquista in both a 200-mg and 400-mg dose for use as an adjunct to
insulin therapy to improve blood sugar (glycemic) control in adults
with type 1 diabetes (T1D) mellitus with a body mass index (BMI) ≥
27 kg/m2, who have failed to achieve adequate glycemic control
despite optimal insulin therapy. Subsequent to quarter-end,
Zynquista received formal approval in the European Union in
accordance with the CHMP opinion.
First Quarter 2019 Financial
Highlights
Revenues: Revenues for the
three months ended March 31, 2019 decreased to $9.2 million from
$25.4 million for the corresponding period in 2018, primarily due
to lower revenues recognized from our collaboration and license
agreement with Sanofi, partially offset by a milestone payment from
Ipsen and an increase in net product revenues. Net product
revenues for the three months ended March 31, 2019 included $6.7
million from net sales of XERMELO in the U.S., up 24% from the
corresponding period in 2018.
Cost of Sales: Cost of sales
related to sales of XERMELO for the three months ended March 31,
2019 and 2018 was $0.6 million and $0.5 million, respectively.
Research and Development (R&D)
Expenses: Research and development expenses for the three
months ended March 31, 2019 decreased to $12.0 million from $47.7
million for the corresponding period in 2018, 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 March 31, 2019 decreased to
$14.1 million from $14.9 million for the corresponding period in
2018, primarily due to decreased marketing costs, partially offset
by higher salaries and benefits related to increased headcount.
Net Loss: Net loss for the
three months ended March 31, 2019 was $21.8 million, or $0.21 per
share, compared to a net loss of $41.8 million, or $0.40 per share,
in the corresponding period in 2018. For the three months ended
March 31, 2019 and 2018, net loss included non-cash, stock-based
compensation expense of $3.4 million and $3.1 million,
respectively.
Cash and Investments: As of
March 31, 2019, Lexicon had $133.1 million in cash and investments,
as compared to $160.1 million as of December 31, 2018.
Anticipated Near-Term
Milestones
- June, September 2019 – Presentation
of new analyses from pivotal studies of sotagliflozin in type 1
diabetes at the annual ADA and EASD meetings
- 2H 2019 – Topline Phase 1b data for
LX9211
- 2019 – Topline results from core
Phase 3 studies for sotagliflozin in type 2 diabetes
- 2019 – Completion of patient
enrollment of the initial safety cohort in the Phase 2 study for
telotristat ethyl in biliary tract cancer
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 8663398. 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 Zynquista
(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). Zynquista has been
approved in the European Union for use as an adjunct to insulin
therapy to improve glycemic control in adults with type 1 diabetes
and a body mass index ≥ 27 kg/m2, who could not achieve adequate
glycemic control despite optimal insulin therapy. Sotagliflozin has
not yet been approved for use in any other jurisdiction.
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 telotristat ethyl, 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 telotristat ethyl,
sotagliflozin, 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, 2018, 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) |
2019 |
|
2018 |
|
|
|
|
|
(Unaudited) |
Revenues: |
|
|
|
Net product revenue |
$ |
6,740 |
|
|
$ |
5,460 |
|
Collaborative agreements |
|
2,439 |
|
|
|
19,832 |
|
Royalties
and other revenue |
|
37 |
|
|
|
82 |
|
Total
revenues |
|
9,216 |
|
|
|
25,374 |
|
Operating expenses: |
|
|
|
Cost of
sales (including finite-lived intangible asset amortization) |
|
553 |
|
|
|
533 |
|
Research and
development, including stock-based compensation |
|
|
|
of $1,768
and $1,655, respectively |
|
12,022 |
|
|
|
47,696 |
|
Selling,
general and administrative, including stock-based compensation |
|
|
|
of $1,643
and $1,419, respectively |
|
14,110 |
|
|
|
14,857 |
|
Total
operating expenses |
|
26,685 |
|
|
|
63,086 |
|
Loss from operations |
|
(17,469 |
) |
|
|
(37,712 |
) |
Interest expense |
|
(5,117 |
) |
|
|
(5,113 |
) |
Interest and other
income, net |
|
789 |
|
|
|
1,005 |
|
Net loss |
$ |
(21,797 |
) |
|
$ |
(41,820 |
) |
|
|
|
|
|
|
|
|
Net loss
per common share, basic and diluted |
$ |
(0.21 |
) |
|
$ |
(0.40 |
) |
|
|
|
|
Shares used in computing
net loss per common share, basic and diluted |
|
106,054 |
|
|
|
105,668 |
|
|
|
|
|
|
|
|
|
Consolidated
Balance Sheet Data |
As of March 31, 2019 |
|
As of December 31, 2018 |
(In thousands) |
(Unaudited) |
|
|
|
|
|
|
Cash and
investments |
$ |
133,145 |
|
|
$ |
160,052 |
|
Property and
equipment, net |
|
15,475 |
|
|
|
15,865 |
|
Goodwill |
|
44,543 |
|
|
|
44,543 |
|
Other
intangible assets |
|
49,678 |
|
|
|
50,119 |
|
Total
assets |
|
258,516 |
|
|
|
284,136 |
|
Deferred
revenue |
|
27,055 |
|
|
|
27,046 |
|
Current
and long-term debt |
|
245,027 |
|
|
|
245,002 |
|
Accumulated deficit |
|
(1,493,374 |
) |
|
|
(1,471,577 |
) |
Total
stockholders' equity (deficit) |
|
(45,687 |
) |
|
|
(26,405 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 Aug 2024 to Sep 2024
Lexicon Pharmaceuticals (NASDAQ:LXRX)
Historical Stock Chart
From Sep 2023 to Sep 2024