XERMELO® (telotristat ethyl)
2018 U.S. Net Sales Reached $25.0 Million
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported
financial results for the three months and full-year ended December
31, 2018 and provided a business update.
“In 2018, we achieved continued growth in
XERMELO net sales and executed well against our strategic
priorities,” said Lonnel Coats, Lexicon’s president and chief
executive officer. “We made significant progress on our pipeline,
which included Sanofi’s submission of marketing applications for
sotagliflozin in type 1 diabetes in the U.S. and Europe as well as
advancement of our earlier-stage product candidates, LX2761 in
diabetes and LX9211 in neuropathic pain. In 2019, our focus remains
on creating long-term value for the company by executing on our
strategic and financial objectives.”
Fourth Quarter and Full-Year 2018
Product and Pipeline Highlights
XERMELO (telotristat ethyl) 250
mg
- XERMELO U.S. net sales reached $25.0 million in 2018.
- XERMELO received national reimbursement approval in Scotland,
Denmark, Sweden, Greece, Luxemburg, Northern Ireland, Wales,
Germany, Belgium and the Netherlands for the treatment of carcinoid
syndrome diarrhea in combination with somatostatin analog (SSA)
therapy in adults inadequately controlled by SSA therapy.
- Positive analyses on time to sustained improvement in bowel
movement frequency with XERMELO were presented at the American
Society of Clinical Oncology’s Gastrointestinal Cancers Symposium
(ASCO GI) and the European Neuroendocrine Tumor Society Conference
(ENETS).
- Favorable changes in weight in patients on XERMELO with
neuroendocrine tumors (NETs) and carcinoid syndrome who
participated in the TELESTAR study along with biochemical and
metabolic improvements in diarrhea severity and nutritional status
were published in Clinical Therapeutics.
SotagliflozinType 1
Diabetes
- Additional positive 52-week data from the pivotal inTandem1 and
inTandem2 studies for sotagliflozin in type 1 diabetes were
presented at the 78th annual American Diabetes Association
Scientific Sessions (ADA) and the European Association for the
Study of Diabetes (EASD) 54th annual meeting and published in
Diabetes Care.
- Lexicon’s collaborator, Sanofi, submitted a New Drug
Application (NDA) and a Marketing Authorization Application (MAA)
for sotagliflozin in type 1 diabetes and the regulatory filings
were accepted by the Food and Drug Administration (FDA) and
European Medicines Agency (EMA), respectively.
- On January 17, 2019, the FDA Endocrinologic and Metabolic Drugs
Advisory Committee voted eight to eight on the question of whether
the overall benefits of sotagliflozin outweighed the risks to
support approval in type 1 diabetes.
- On February 28, 2019, the EMA Committee for Medicinal Products
for Human Use adopted a positive opinion recommending regulatory
approval of sotagliflozin for use as an adjunct to insulin therapy
to improve glycemic control in adults with type 1 diabetes with a
body mass index of 27 kg/m2 or greater, who have failed to achieve
adequate glycemic control despite optimal insulin therapy.
- A target FDA action date under the Prescription Drug User Fee
Act (PDUFA) is set for March 22, 2019 and a regulatory decision by
the European Commission is expected in Q2 2019.
Type 2 Diabetes
- Patient enrollment continued for eleven Phase 3 sotagliflozin
clinical trials in type 2 diabetes being conducted by Sanofi.
- Patient enrollment was completed in the nine Phase 3 clinical
trials that support the planned filings for regulatory approval of
sotagliflozin in type 2 diabetes.
- Sanofi initiated two additional Phase 3 studies for
sotagliflozin in Chinese patients with type 2 diabetes
(NCT03760965, NCT03761134).
LX2761
- Lexicon announced topline results from Phase 1 clinical studies
of LX2761, an orally-administered, selective sodium-glucose
cotransporter type 1 (SGLT1) inhibitor, in healthy subjects and
patients with type 2 diabetes that confirmed the drug’s unique
preclinical profile as a potent gastrointestinal tract-selective
SGLT1 inhibitor.
LX9211
- Lexicon announced positive topline results from a Phase 1a
clinical study of LX9211, an orally-administered, selective
adapter-associated kinase 1 (AAK1) inhibitor that is being
developed for neuropathic pain. The Phase 1a study met its primary
objectives, identifying a maximum tolerated dose and demonstrating
a safety and tolerability profile in healthy human subjects
supporting progression of the clinical program.
Fourth Quarter and Full-Year 2018
Financial Highlights
Unless otherwise stated, all comparisons are for
the fourth quarter and full year of 2018 compared to the fourth
quarter and full year of 2017.
Revenues: Revenues for the
fourth quarter decreased to $17.1 million from $34.0 million for
the corresponding period in 2017, primarily due to lower revenues
recognized under collaboration and license agreements. Full-year
2018 revenues decreased to $63.2 million from $91.7 million,
primarily due to timing of revenues recognized from clinical trial
activities under the collaboration and license agreements with
Sanofi and decreases in milestone payments from Ipsen, partially
offset by an increase in net product revenue. Net product revenues
for full-year 2018 included $25.0 million and $1.6 million,
respectively, from net sales of XERMELO in the U.S. and the sale of
bulk tablets to Lexicon’s collaborator, Ipsen.
Cost of Sales: Cost of sales
related to sales of XERMELO was $0.6 million and $0.5 million,
respectively, for the fourth quarter of 2018 and 2017. Full-year
2018 and 2017 cost of sales was $2.5 million and $1.9 million,
respectively.
Research and Development (R&D)
Expenses: Research and development expenses for the fourth
quarter decreased to $12.3 million from $46.3 million for the
corresponding period in 2017, primarily due to decreases in our
external clinical development costs relating to sotagliflozin.
Full-year 2018 R&D expenses decreased to $100.2 million from
$152.2 million, primarily due to lower external clinical
development costs relating to sotagliflozin and professional and
consulting fees.
Selling, General and Administrative
(SG&A) Expenses: Selling, general and administrative
expenses for the fourth quarter were $16.6 million compared to
$16.1 million for the same period in 2017. Full-year 2018 SG&A
expenses decreased to $63.8 million from $66.1 million, primarily
due to lower salaries and benefits, and decreased marketing
costs.
Income Tax Benefit: During
2018, there was no income tax benefit. During 2017, Lexicon
recognized an $8.7 million income tax benefit when the intangible
assets relating to XERMELO were reclassified from indefinite-lived
to finite-lived assets. The income tax benefit was remeasured to
$12.7 million for full year 2017.
Net Loss: Net loss for the
fourth quarter was $16.8 million, or $0.16 per share, compared to a
net loss of $26.6 million, or $0.25 per share, in the corresponding
period in 2017. For the fourth quarter 2018, net loss included
non-cash, stock-based compensation expense of $2.8 million.
For the fourth quarter 2017, net loss included non-cash,
stock-based compensation expense of $2.3 million. Net loss for
the full-year 2018 was $120.5 million, or $1.14 per share, compared
to a net loss of $123.0 million, or $1.17 per share, in 2017. For
the full-year 2018, net loss included non-cash, stock-based
compensation expense of $11.7 million. For the full-year 2017,
net loss included non-cash, stock-based compensation expense of
$9.5 million.
Cash and Investments: As of
December 31, 2018, Lexicon had $160.1 million in cash and
investments, as compared to $310.8 million as of December 31,
2017.
Anticipated Upcoming
Milestones
- Q1 2019 – Manuscript publications for XERMELO in carcinoid
syndrome diarrhea
- Q1 2019 – Initiation of a Phase 1b study for LX9211
- March 22, 2019 – PDUFA date for sotagliflozin in type 1
diabetes in the U.S.
- Q2 2019 – European Commission decision on marketing application
for sotagliflozin in type 1 diabetes in the EU
- 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 data from core Phase 3 studies for sotagliflozin
in type 2 diabetes
- 2019 – Patient enrollment in a 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 6598765. 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
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 Marketing Authorization Application for sotagliflozin in type 1
diabetes are currently under review at the U.S. Food and Drug
Administration and European Medicines Agency, respectively. The
product has not yet been approved for use in the U.S., European
Union or 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, 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 December 31, |
|
Year Ended December 31, |
(In thousands, except
per share data) |
|
2018 |
|
2017 |
|
2018 |
|
2017 |
|
|
|
|
(Restated) |
|
|
|
(Restated) |
|
|
(Unaudited) |
|
(Unaudited) |
Revenues: |
|
|
|
|
|
|
|
|
Net product
revenue |
|
$ |
7,521 |
|
|
$ |
5,447 |
|
|
$ |
26,583 |
|
|
$ |
15,890 |
|
Collaborative agreements |
|
|
9,479 |
|
|
|
28,405 |
|
|
|
36,271 |
|
|
|
75,621 |
|
Royalties
and other revenue |
|
|
71 |
|
|
|
114 |
|
|
|
355 |
|
|
|
178 |
|
Total
revenues |
|
|
17,071 |
|
|
|
33,966 |
|
|
|
63,209 |
|
|
|
91,689 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Cost of
sales (including finite-lived intangible asset amortization) |
|
|
569 |
|
|
|
538 |
|
|
|
2,491 |
|
|
|
1,899 |
|
Research
and development, including stock-based compensation |
|
|
|
|
|
|
|
|
of
$1,488, $1,207, $6,010 and $4,905, respectively |
|
|
12,306 |
|
|
|
46,311 |
|
|
|
100,243 |
|
|
|
152,223 |
|
Increase
in fair value of Symphony Icon purchase liability |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
2,101 |
|
Selling,
general and administrative, including stock-based compensation |
|
|
|
|
|
|
|
|
of
$1,359, $1,051, $5,686 and $4,567, respectively |
|
|
16,563 |
|
|
|
16,133 |
|
|
|
63,754 |
|
|
|
66,090 |
|
Total
operating expenses |
|
|
29,438 |
|
|
|
62,982 |
|
|
|
166,488 |
|
|
|
222,313 |
|
Loss from
operations |
|
|
(12,367 |
) |
|
|
(29,016 |
) |
|
|
(103,279 |
) |
|
|
(130,624 |
) |
Interest
expense |
|
|
(5,224 |
) |
|
|
(2,163 |
) |
|
|
(20,777 |
) |
|
|
(6,984 |
) |
Interest and other
income, net |
|
|
810 |
|
|
|
561 |
|
|
|
3,508 |
|
|
|
1,954 |
|
Net loss
before income taxes |
|
|
(16,781 |
) |
|
|
(30,618 |
) |
|
|
(120,548 |
) |
|
|
(135,654 |
) |
Income
tax benefit |
|
|
- |
|
|
|
4,009 |
|
|
|
- |
|
|
|
12,661 |
|
Net
loss |
|
$ |
(16,781 |
) |
|
$ |
(26,609 |
) |
|
$ |
(120,548 |
) |
|
$ |
(122,993 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
per common share, basic and diluted |
|
$ |
(0.16 |
) |
|
$ |
(0.25 |
) |
|
$ |
(1.14 |
) |
|
$ |
(1.17 |
) |
|
|
|
|
|
|
|
|
|
Shares used in
computing net loss per common share, basic and diluted |
|
|
105,920 |
|
|
|
105,588 |
|
|
|
105,830 |
|
|
|
105,237 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated
Balance Sheet Data |
|
|
|
|
|
As of December 31, 2018 |
|
As of December 31, 2017 |
(In thousands) |
|
|
|
|
|
|
|
(Restated) |
|
|
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
Cash and investments |
|
$ |
160,052 |
|
|
$ |
310,788 |
|
Property and equipment, net |
|
|
15,865 |
|
|
|
17,687 |
|
Goodwill |
|
|
44,543 |
|
|
|
44,543 |
|
Other intangible assets |
|
|
50,119 |
|
|
|
51,885 |
|
Total assets |
|
|
284,136 |
|
|
|
436,539 |
|
Deferred revenue |
|
|
27,046 |
|
|
|
65,254 |
|
Current and long-term debt |
|
|
245,002 |
|
|
|
245,670 |
|
Accumulated deficit |
|
|
(1,471,577 |
) |
|
|
(1,365,241 |
) |
Total stockholders' (deficit) equity |
|
|
(26,405 |
) |
|
|
68,265 |
|
|
|
|
|
|
|
|
|
|
Restatement of
Previously Issued Financial Statements: During the
financial close for fiscal year 2018, the Company determined that
the research and development expenses from prior periods were
overstated. The financial information for prior periods has been
restated to reflect these adjustments. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 AdvocacyLexicon Pharmaceuticals(281)
863-3421cschultz@lexpharma.com
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