Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported
financial results and provided a business update for the three
months ended March 31, 2020.
“We achieved 17% growth in XERMELO net sales for
the first quarter of 2020 compared to the prior-year period, and we
see favorable growth dynamics going forward,” said Lonnel Coats,
Lexicon’s president and chief executive officer. “We have made good
progress on our pipeline, having fully enrolled the first efficacy
cohort of 20 patients in the Phase 2 telotristat ethyl study in
biliary tract cancer from which we expect top-line data later this
year. Importantly, we are steps closer to advancing our next major
innovation, LX9211, into a proof-of-concept study in diabetic
peripheral neuropathic pain, which we expect to initiate mid-year.
Finally, we are making progress on the close-out of the two
sotagliflozin outcome studies, SCORED and SOLOIST, which we expect
to conclude in the near term.”
First Quarter Product and Pipeline
Highlights
XERMELO® (telotristat
ethyl)
- XERMELO U.S. net sales were $7.9 million in the first quarter
of 2020.
- Medical record data on XERMELO’s antiproliferative effects were
presented at the American Society for Clinical Oncology (ASCO) 2020
Symposium in gastrointestinal cancers, showing that, among 200
patients with metastatic neuroendocrine tumors on standard
background therapies, the mean tumor size was 0.59 cm smaller
(p=0.006) in scans obtained after initiation of XERMELO.
- Medical record data on XERMELO’s antiproliferative effects in
patients with carcinoid syndrome presented at the European
Neuroendocrine Tumor Society (ENETS) meeting demonstrated that most
patients with metastatic neuroendocrine tumors on standard
background therapies had no tumor progression at 6, 12 and 18
months following initiation of XERMELO, with a median time to tumor
progression (TTP) of 39.8 months. The majority of patients also
experienced progression-free survival (PFS) in the period following
initiation of XERMELO, with a median PFS of 23.7 months. In
addition, in a subset of 22 patients with recorded biomarker data,
mean serotonin levels decreased significantly in the period
following initiation of XERMELO. Patients also improved on
carcinoid syndrome (CS) symptoms, body weight and performance
status.
- 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,
completed enrollment of 20 patients in the first efficacy
cohort.
Sotagliflozin
- In March, Lexicon announced the early close-out of the two
long-term outcomes studies of sotagliflozin, SCORED and SOLOIST,
that were originally designed to demonstrate benefits in and
support labeling for heart failure and chronic kidney disease.
First Quarter 2020 Financial
Highlights
Revenues: Revenues for the
three months ended March 31, 2020 decreased to $8.0 million from
$9.2 million for the corresponding period in 2019, primarily due to
a decrease of collaborative revenues, partially offset by an
increase in net product revenue. Net product revenues for the three
months ended March 31, 2020 consisted of $7.9 million from net
sales of XERMELO in the U.S., up 17% from the prior year
quarter.
Cost of Sales: Cost of sales
related to sales of XERMELO for each of the three months ended
March 31, 2020 and 2019 was $0.6 million.
Research and Development (R&D)
Expenses: Research and development expenses for the three
months ended March 31, 2020 increased to $55.2 million from $12.0
million for the corresponding period in 2019, primarily due to
increases in external clinical development costs related to
sotagliflozin subsequent to the termination of the alliance with
Sanofi.
Selling, General and Administrative
(SG&A) Expenses: Selling, general and administrative
expenses for the three months ended March 31, 2020 were $14.7
million as compared to $14.1 million for the corresponding period
in 2019.
Net Loss: Net loss for the
three months ended March 31, 2020 was $66.6 million, or $0.63 per
share, as compared to a net loss of $21.8 million, or $0.21 per
share, in the corresponding period in 2019. For the three months
ended March 31, 2020 and 2019, net income included non-cash,
stock-based compensation expense of $4.4 million and $3.4
million, respectively.
Cash and Investments: As of
March 31, 2020, Lexicon had $249.1 million in cash and investments,
as compared to $271.7 million as of December 31, 2019.
Anticipated Near-Term
Milestones
- Mid-2020 – Initiation of the Phase 2 study for LX9211 in
diabetic peripheral neuropathic pain
- Q4 2020 – Data from the first efficacy cohort of the Phase 2
study of telotristat ethyl in biliary tract cancer
- 2020 – Manuscript publications for XERMELO in carcinoid
syndrome diarrhea
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 9403118. 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. XERMELO
targets tryptophan hydroxylase, an enzyme that mediates the excess
serotonin production within metastatic neuroendocrine tumor (mNET)
cells. XERMELO is approved in the United States, the European Union
and certain additional countries for the treatment of carcinoid
syndrome diarrhea in combination with somatostatin analog (SSA)
therapy in adults inadequately controlled by SSA therapy. Carcinoid
syndrome is a rare condition that occurs in patients living with
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.
Lexicon has granted Ipsen an exclusive
royalty-bearing right and license to commercialize XERMELO outside
of the United States and Japan. We are commercializing XERMELO in
the United States and Ipsen is commercializing XERMELO in multiple
countries, including the United Kingdom and Germany.
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 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.
Sotagliflozin is approved in the European Union (EU) for use as an
adjunct to insulin therapy to improve blood sugar (glycemic)
control in adults with type 1 diabetes with a body mass index ≥ 27
kg/m2, who could not achieve adequate glycemic control despite
optimal insulin therapy.
About Lexicon
Pharmaceuticals
Lexicon is a fully integrated biopharmaceutical
company with a mission of pioneering medicines that transform
patients’ lives. Through its Genome5000™ program, Lexicon
scientists studied the role and function of nearly 5,000 genes and
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, Lexicon has a pipeline of promising drug candidates in
clinical and preclinical development in diabetes and metabolism,
oncology 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 clinical development of, the
regulatory filings for, and the potential therapeutic and
commercial potential of XERMELO (telotristat ethyl), sotagliflozin,
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, 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, 2019, 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) |
2020 |
|
2019 |
|
(Unaudited) |
Revenues: |
|
|
|
Net product revenue |
$ |
7,877 |
|
|
$ |
6,740 |
|
Collaborative agreements |
|
8 |
|
|
|
2,439 |
|
Royalties and other revenue |
|
114 |
|
|
|
37 |
|
Total revenues |
|
7,999 |
|
|
|
9,216 |
|
Operating
expenses: |
|
|
|
Cost of sales (including finite-lived intangible asset
amortization) |
|
568 |
|
|
|
553 |
|
Research and development, including stock-based compensation |
|
|
|
|
|
of $2,176 and $1,768, respectively |
|
55,181 |
|
|
|
12,022 |
|
Selling, general and administrative, including stock-based
compensation |
|
|
|
|
|
of $2,256 and $1,643, respectively |
|
14,688 |
|
|
|
14,110 |
|
Total operating expenses |
|
70,437 |
|
|
|
26,685 |
|
Loss from
operations |
|
(62,438 |
) |
|
|
(17,469 |
) |
Interest
expense |
|
(5,131 |
) |
|
|
(5,117 |
) |
Interest and
other income, net |
|
958 |
|
|
|
789 |
|
Net
loss |
$ |
(66,611 |
) |
|
$ |
(21,797 |
) |
|
|
|
|
|
|
|
|
Net loss per
common share, basic and diluted |
$ |
(0.63 |
) |
|
$ |
(0.21 |
) |
|
|
|
|
Shares used
in computing net loss per common share, basic and diluted |
|
106,536 |
|
|
|
106,054 |
|
|
|
|
|
|
|
|
|
Consolidated Balance Sheet Data |
As of March 31, 2020 |
|
As of December 31, 2019 |
(In
thousands) |
(Unaudited) |
|
|
|
|
|
|
Cash and investments |
$ |
249,137 |
|
|
$ |
271,659 |
|
Property and equipment, net |
|
13,582 |
|
|
|
14,047 |
|
Goodwill |
|
44,543 |
|
|
|
44,543 |
|
Intangible assets |
|
19,275 |
|
|
|
19,716 |
|
Total assets |
|
370,567 |
|
|
|
417,715 |
|
Current and long-term debt |
|
245,222 |
|
|
|
245,183 |
|
Accumulated deficit |
|
(1,408,055 |
) |
|
|
(1,341,444 |
) |
Total stockholders' equity |
|
54,777 |
|
|
|
117,101 |
|
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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