XERMELO® (telotristat ethyl)
U.S. Net Sales Since March 2017 Launch Reach $15.1 Million
Lexicon Pharmaceuticals, Inc. (Nasdaq:LXRX), today reported
financial results for the three months and full-year ended December
31, 2017 and highlighted progress with the company’s 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 EST / 7:00 am CST to discuss the
financial results and to provide a business update.
“2017 was a historic inflection point for
Lexicon as we became a fully-integrated, commercial-stage
biopharmaceutical company with the launch of our first product,
XERMELO, bringing a novel, oral tryptophan hydroxylase inhibitor to
market,” said Lonnel Coats, Lexicon’s president and chief executive
officer.
Accomplishments in 2017 included:
- The approval and launch of XERMELO in the U.S and Europe,
- Completion of the registrational sotagliflozin clinical program
in type 1 diabetes, encompassing three successful Phase 3 clinical
trials which delivered the largest body of safety and efficacy data
ever for a potential oral adjunct to insulin therapy for type 1
diabetes and the broadest range of adult patients,
- Initiation of Phase 3 studies for sotagliflozin scheduled to
enroll more than 15,000 patients with type 2 diabetes by our
collaborator, Sanofi, including dedicated studies in patients with
stage 3 and 4 chronic kidney disease (SOTA-CKD3 and SOTA-CKD4) and
a 10,500-patient cardiovascular and renal outcomes trial (SCORE),
and
- Advancement of our earlier-stage pipeline, including initiation
of human clinical trials of LX2761 and LX9211 in diabetes and
neuropathic pain, respectively.
“We enter 2018 with a well-defined strategy to
position the company for future growth and to build long-term
sustainable value for shareholders,” continued Mr. Coats. “XERMELO
remains a significant franchise for us, and we are extremely
excited about exploring the use of telotristat ethyl in additional
therapeutic indications where the role of serotonin inhibition has
shown preclinical promise. In parallel, we and Sanofi look forward
to filing for regulatory approval in the U.S. and in Europe for
sotagliflozin in type 1 diabetes in the upcoming weeks. Lastly, we
continue to advance our earlier-stage product candidates in areas
we believe will create long-term value for the company.”
Fourth Quarter and Full-Year 2017
Product and Pipeline Highlights
XERMELO (telotristat ethyl) 250
mg
In 2017, XERMELO was approved and launched in
the U.S. and in the European Union as the first and only oral
treatment for carcinoid syndrome diarrhea in combination with
somatostatin analog (SSA) therapy in adult cancer patients with
metastatic neuroendocrine tumors (NETs) inadequately controlled by
SSA therapy. Within three months of the U.S. launch, XERMELO was
included in NCCN guidelines in oncology.
- The FDA and EMA approved XERMELO 250 mg in the U.S. and in the
European Union in February and September, respectively.
- XERMELO was launched in the U.S. shortly after approval and was
included as a recommended treatment option in the latest National
Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in
Oncology for NET patients with carcinoid syndrome diarrhea. The
NCCN designated XERMELO together with SSA therapy as a category 2A
treatment for adults inadequately controlled by SSA therapy.
XERMELO was also included in the NCCN Drugs & Biologics
Compendium.
- Ipsen, Lexicon’s collaborator, launched XERMELO for the
treatment of carcinoid syndrome diarrhea in combination with SSA
therapy in adults inadequately controlled by SSA therapy in the
United Kingdom, Germany and Austria.
SotagliflozinType 1
Diabetes
In 2017, sotagliflozin achieved favorable
results from the inTandem Phase 3 clinical program in type 1
diabetes, with the publication of inTandem3 results in the
September issue of New England Journal of Medicine, and U.S. and
European Union regulatory filings expected in 1Q 2018.
- Lexicon announced statistically significant 24-week inTandem1
and inTandem2 primary endpoint data and outcomes on secondary
endpoints at 24 weeks (presented at the 77th American Diabetes
Association (ADA) Scientific Sessions and the European Association
for the Study of Diabetes (EASD) 53rd annual meeting), as well as
maintenance of benefit and favorable safety results at 52
weeks.
- Lexicon exercised its option under its collaboration and
license agreement with Sanofi to co-promote sotagliflozin for the
treatment of type 1 diabetes in the U.S.
- Lexicon announced positive pooled continuous glucose monitoring
data from the pivotal Phase 3 inTandem1 and inTandem2 studies of
sotagliflozin.
- The company announced positive top-line inTandem3 results which
were published in the New England Journal of Medicine.
Type 2 Diabetes
Sanofi launched a robust type 2 diabetes
clinical program for sotagliflozin, encompassing more than 15,000
patients and including dedicated studies in patients with stage 3
and 4 chronic kidney disease and a 10,500-patient cardiovascular
and renal impairment outcomes study. Lexicon expects data from core
studies in 2019 followed by regulatory filings in Europe and U.S.
in 2H 2019 and 1H 2020, respectively.
- Sanofi initiated the following Phase 3 sotagliflozin studies in
type 2 diabetes:
- Efficacy and safety of sotagliflozin versus placebo in patients
with type 2 diabetes mellitus on background of sulfonylurea alone
or with metformin (NCT03066830)
- Safety and efficacy study of sotagliflozin on glucose control
in patients with type 2 diabetes, moderate impairment of kidney
function, and inadequate blood sugar control (SOTA-CKD3;
NCT03242252)
- Safety and effects of sotagliflozin dose 1 and dose 2 on
glucose control in patients with type 2 diabetes, severe impairment
of kidney function and inadequate blood sugar control (SOTA-CKD4;
NCT03242018)
- Efficacy and safety of sotagliflozin versus placebo in subjects
with type 2 diabetes mellitus who have inadequate glycemic control
while taking insulin alone or with other oral antidiabetic agents
(SOTA-INS; NCT03285594)
- Effect of sotagliflozin on cardiovascular and renal events in
patients with type 2 diabetes and moderate renal impairment who are
at cardiovascular risk (SCORED study; NCT03315143)
- Efficacy and safety of sotagliflozin versus glimepiride and
placebo in subjects with type 2 diabetes mellitus who are taking
metformin monotherapy (SOTA-GLIM study; NCT03332771)
- Efficacy and safety of sotagliflozin versus placebo and
empagliflozin in subjects with type 2 diabetes mellitus who have
inadequate glycemic control while taking a DPP4 inhibitor alone or
with metformin (SOTA-EMPA; NCT03351478)
- Efficacy and bone safety of sotagliflozin versus placebo in
subjects with type 2 diabetes mellitus who have inadequate glycemic
control (SOTA-BONE; NCT03386344)
LX2761
Lexicon advanced LX2761, an orally-administered
drug candidate targeted to the inhibition of SGLT1 in the
gastrointestinal tract, into human clinical studies for the
treatment of diabetes, with Phase 1b data expected in 1H 2018.
- Lexicon completed a Phase 1a study of LX2761 in healthy
subjects and patients with type 2 diabetes.
- Lexicon initiated a Phase 1b clinical trial of LX2761 in
patients with type 2 diabetes.
LX9211
Lexicon advanced LX9211, a novel therapeutic
approach to treat neuropathic pain, into human clinical studies,
with Phase 1a data expected in 2H 2018.
- Lexicon continued to advance a Phase 1a clinical trial of
LX9211, an orally-administered drug candidate selectively targeted
to the inhibition of AAK1 (adapter-associated kinase 1) that is
being developed for neuropathic pain.
Fourth Quarter and Full-Year 2017
Business Highlights
- Lexicon entered into a definitive term loan agreement with
BioPharma Credit PLC and BioPharma Credit Investments IV Sub LP,
investment funds managed by Pharmakon Advisors, L.P., that provided
Lexicon with up to $200 million of borrowing capacity available in
two tranches, each maturing in December 2022 and bearing interest
at 9.0% per annum. The first $150 million was available immediately
and an additional tranche of $50 million is available for draw by
March 2019 at Lexicon’s option if net XERMELO sales are greater
than $25 million in the preceding quarter.
Fourth Quarter and Full-Year 2017
Financial Highlights
Unless otherwise stated, all comparisons are for
the fourth quarter and full year of 2017 compared to the fourth
quarter and full year of 2016.
Revenues: Revenues for the
fourth quarter increased 43% from the prior-year period to $33.0
million, primarily due to milestone payments from the Ipsen
alliance for the first commercial sale of XERMELO in the United
Kingdom and Germany, and $5.4 million in net product revenues.
Full-year 2017 revenues were $90.3 million, an increase of 8%
year-over-year, primarily due to net product sales and partially
offset by lower revenues recognized from the collaboration and
license agreement with Sanofi. Net product revenues since March
2017 included $15.1 million and $0.8 million, respectively, from
the sale of XERMELO in the U.S. and the sale of bulk tablets of
telotristat ethyl to Ipsen.
Cost of Sales: Lexicon had cost
of sales related to sales of XERMELO of $0.5 million for the fourth
quarter of 2017. Full-year 2017 cost of sales was $1.9 million, of
which $1.5 million consisted of amortization of intangible
assets.
Research and Development (R&D)
Expenses: Research and development expenses increased to
$47.2 million for the fourth quarter from $40.4 million for the
same period in 2016, primarily due to professional and consulting
fees related to sotagliflozin NDA preparation and higher clinical
and preclinical external research and development expenses.
Full-year 2017 R&D expenses decreased 12% to $156.8 million,
primarily due to lower clinical and preclinical external research
and development costs.
Selling, General and Administrative
(SG&A) Expenses: Selling, general and administrative
expenses for the fourth quarter were $16.1 million compared to
$14.0 million for the same period in 2016. The increase was
primarily due to higher legal expenses, professional and consulting
expenses, salaries and benefits expense, charitable contributions
and stock-based compensation. Full-year 2017 SG&A expenses were
$66.2 million for 2017 compared to $43.0 million for 2016. The
full-year 2017 increase in SG&A expenses were primarily due to
increased salaries and benefits expense, travel and entertainment,
charitable contributions, legal expenses and stock-based
compensation.
Income Tax Benefit: During
2017, Lexicon’s valuation allowance for its deferred tax assets
decreased by $8.7 million due to the reclassification of intangible
assets relating to XERMELO from indefinite-lived to finite-lived
assets. This resulted in the related deferred tax liability now
being considered a source of taxable income. Lexicon recorded a
deferred tax benefit with a corresponding reduction in its deferred
tax liability in connection with this reclassification. On December
22, 2017, the Tax Cuts and Jobs Act was enacted and reduced the
U.S. federal corporate tax rate from 35 percent to 21 percent. As a
result, the fourth quarter 2017 income tax benefit of $4.0 million
represents the re-measurement of the deferred tax benefit and
related valuation allowance to the newly enacted U.S. federal
corporate tax rate.
Consolidated Net Loss: Net loss
for the fourth quarter was $28.4 million, or $0.27 per share,
compared to a net loss of $32.4 million, or $0.31 per share, in the
corresponding period in 2016. For the fourth quarter 2017, net loss
included non-cash, stock-based compensation expense of
$2.3 million. For the fourth quarter 2016, net loss included
non-cash, stock-based compensation expense of $1.7 million.
Net loss for the full-year 2017 was $129.1 million, or $1.23,
compared to a net loss of $141.4 million, or $1.36 per share, in
the corresponding period in 2016. For the full-year 2017, net loss
included non-cash, stock-based compensation expense of
$9.5 million. For the full-year 2016, net loss included
non-cash, stock-based compensation expense of
$7.5 million.
Cash and Investments: As of
December 31, 2017, Lexicon had $310.8 million in cash and
investments, as compared to $346.5 million as of December 31,
2016. The cash position as of December 31, 2017 includes net
proceeds of $145.9 million from the loan agreement discussed
above.
Anticipated Upcoming
Milestones
- 1Q 2018 – U.S. and EU regulatory filings for sotagliflozin in
type 1 diabetes by Sanofi
- 1H 2018 – Initiation of additional Phase 3 sotagliflozin
studies in type 2 diabetes by Sanofi
- 1H 2018 – Phase 1b data for LX2761 in patients with type 2
diabetes
- 2H 2018 – Phase 1a data for LX9211 in neuropathic pain
- 2018 – Manuscript publications for XERMELO and
sotagliflozin
- 2018 – Launch of XERMELO in additional European countries
- 2018 – Initiation of clinical studies for telotristat ethyl in
other therapeutic indications
Conference Call and Webcast
Information
Lexicon management will hold a live conference
call and webcast today at 8:00 am EST / 7:00 am CST 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 3395518. 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 a new 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 commercial business, including 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 conduct
preclinical and clinical development and obtain necessary
regulatory approvals of sotagliflozin, LX2761 and 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, 2016, 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) |
|
2017 |
|
2016 |
|
2017 |
|
2016 |
|
|
(Unaudited) |
|
(Unaudited) |
Revenues: |
|
|
|
|
|
|
|
|
Net
product revenue
.................................................................................................... |
|
$ |
5,447 |
|
$ |
- |
|
$ |
15,890 |
|
$ |
- |
Collaborative agreements
............................................................................................ |
|
27,486 |
|
23,001 |
|
74,267 |
|
83,182 |
Royalties
and other revenue
........................................................................................ |
|
114 |
|
36 |
|
178 |
|
155 |
Total
revenues
......................................................................................................... |
|
33,047 |
|
23,037 |
|
90,335 |
|
83,337 |
Operating
expenses: |
|
|
|
|
|
|
|
|
Cost of
sales (including finite-lived intangible |
|
|
|
|
|
|
|
|
asset
amortization)
........................................................................................…….. |
|
538 |
|
- |
|
1,899 |
|
- |
Research
and development, including stock-based compensation |
|
|
|
|
|
|
|
|
of
$1,207, $925, $4,905 and $3,938, respectively
.................................................. |
|
47,160 |
|
40,400 |
|
156,813 |
|
178,151 |
Increase
(decrease) in fair value of Symphony Icon |
|
|
|
|
|
|
|
|
purchase
liability...................................................................................................... |
|
- |
|
- |
|
2,101 |
|
(703) |
Selling,
general and administrative, including stock-based compensation |
|
|
|
|
|
|
|
|
of
$1,051, $805, $4,567 and $3,514,
respectively.................................................. |
|
16,134 |
|
13,967 |
|
66,203 |
|
43,044 |
Total
operating expenses
....................................................................................... |
|
63,832 |
|
54,367 |
|
227,016 |
|
220,492 |
Loss from operations
..................................................................................................... |
|
(30,785) |
|
(31,330) |
|
(136,681) |
|
(137,155) |
Interest expense
............................................................................................................ |
|
(2,163) |
|
(1,634) |
|
(6,984) |
|
(6,567) |
Interest and other
income,
net........................................................................................ |
|
561 |
|
545 |
|
1,954 |
|
2,293 |
Net loss
before income taxes
........................................................................................ |
|
(32,387) |
|
(32,419) |
|
(141,711) |
|
(141,429) |
Income
tax
benefit.......................................................................................................... |
|
4,009 |
|
- |
|
12,661 |
|
- |
Consolidated net
loss..................................................................................................... |
|
$ |
(28,378) |
|
$ |
(32,419) |
|
$ |
(129,050) |
|
$ |
(141,429) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated net loss per common share, basic and
diluted…………………………….. |
|
$ |
(0.27) |
|
$ |
(0.31) |
|
$ |
(1.23) |
|
$ |
(1.36) |
|
|
|
|
|
|
|
|
|
Shares used in
computing consolidated net loss |
|
|
|
|
|
|
|
|
per
common share, basic and diluted…………………………………………………….. |
|
105,588 |
|
104,052 |
|
105,237 |
|
103,863 |
Consolidated Balance Sheet Data |
|
|
|
As ofDecember
31,2017 |
|
As ofDecember
31,2016 |
(In
thousands) |
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
Cash and investments…………………..……………………………………………………… |
|
$ |
310,788 |
|
$ |
346,504 |
Property and equipment, net…………………………………………………………………… |
|
17,687 |
|
19,390 |
Goodwill……………………………………...………………………………………………....... |
|
44,543 |
|
44,543 |
Other intangible assets…………………………………………………..……………………... |
|
51,885 |
|
53,357 |
Total assets…………..………………………………………………………………………….. |
|
436,539 |
|
475,625 |
Deferred
revenue……………………………………………...……………............................ |
|
62,527 |
|
112,306 |
Current and long-term debt……………………………………………………………………. |
|
245,670 |
|
101,447 |
Accumulated deficit…………………………………………………………………………….. |
|
(1,381,404) |
|
(1,250,363) |
Total stockholders'
equity……………...……………………………………………………..... |
|
52,102 |
|
157,401 |
|
|
|
|
|
For Investor Inquiries:
Kimberly Lee, D.O.Head of Investor Relations and
Corporate StrategyLexicon Pharmaceuticals(281)
863-3383klee@lexpharma.com
For Media Inquiries:
Chas SchultzSenior Director, Corporate
Communications and AdvocacyLexicon Pharmaceuticals(281)
863-3421cschultz@lexpharma.com
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