Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported
financial results and provided a business update for the three
months ended June 30, 2020.
“We achieved 21% growth in XERMELO net sales in
the U.S. for the second quarter of 2020 compared to the prior-year
period, underscoring the importance of our product to patients,”
said Lonnel Coats, Lexicon’s president and chief executive officer.
“In these unprecedented times of the COVID-19 pandemic, I am proud
of the commitment and dedication of our employees to our mission to
pioneer medicines to transform patients’ lives. We continue to make
progress on our pipeline with initiation of screening of patients
in the Phase 2 RELIEF-DPN-1 study for LX9211 in patients with
diabetic peripheral neuropathic pain. We look forward to providing
additional updates later this year.”
Second Quarter Product and Pipeline
Highlights
XERMELO® (telotristat
ethyl)
- XERMELO U.S. net sales were $9.0 million in the second quarter
of 2020.
- Telotristat ethyl’s
antiproliferative effects observed in a preclinical study in
liposarcoma, colon cancer and cholangiocarcinoma cell lines were
published online in conjunction with the American Society of
Clinical Oncology (ASCO) 2020 annual meeting (May 29 - June 2,
2020).
Sotagliflozin
- Six posters for sotagliflozin were
presented at the virtual 80th American Diabetes Association (ADA)
Scientific Sessions (June 12-16, 2020) including additional
efficacy and safety data in patients with type 2 diabetes and
moderate and severe renal impairment.
Second Quarter 2020 Financial
Highlights
Revenues: Revenues for the
three months ended June 30, 2020 decreased to $9.2 million from
$9.7 million for the corresponding period in 2019, primarily due to
a decrease of bulk tablet sales of XERMELO to Ipsen and
collaborative revenues, partially offset by an increase in U.S. net
product revenue. Net product revenues for the three months ended
June 30, 2020 consisted of $9.0 million from net sales of XERMELO
in the U.S., up 21% from the prior year quarter.
Cost of Sales: Cost of sales
related to sales of XERMELO for the three months ended June 30,
2020 and 2019 was $0.7 million and $1.3 million, respectively.
Research and Development (R&D)
Expenses: Research and development expenses for the three
months ended June 30, 2020 increased to $57.3 million from $12.6
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 June 30, 2020 were $14.1
million as compared to $14.3 million for the corresponding period
in 2019.
Net Loss: Net loss for the
three months ended June 30, 2020 was $69.1 million, or $0.65 per
share, as compared to a net loss of $23.0 million, or $0.22 per
share, in the corresponding period in 2019. For the three months
ended June 30, 2020 and 2019, net loss included non-cash,
stock-based compensation expense of $4.3 million and $3.8 million,
respectively.
Cash and Investments: As of
June 30, 2020, Lexicon had $201.9 million in cash and investments,
as compared to $271.7 million as of December 31, 2019.
Anticipated Near-Term
Milestones
- Q3 2020 – Dosing of first patient
in the Phase 2 LX9211 study in diabetic peripheral neuropathic
pain
- Q4 2020 – Initiation of a Phase 2
study for LX9211 in post-herpetic neuralgia
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 4645277. 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.
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Lexicon
Pharmaceuticals, Inc. |
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Selected
Financial Data |
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Consolidated Statements of Operations Data |
|
Three Months Ended June 30, |
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Six Months Ended June 30, |
|
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(In
thousands, except per share data) |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|
|
|
|
(Unaudited) |
|
(Unaudited) |
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Revenues: |
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|
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|
|
|
|
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Net product revenue |
|
$ |
8,985 |
|
|
$ |
8,672 |
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$ |
16,862 |
|
|
$ |
15,412 |
|
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|
Collaborative agreements |
|
|
25 |
|
|
|
860 |
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33 |
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|
|
3,299 |
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Royalties and other revenue |
|
|
153 |
|
|
|
150 |
|
|
|
267 |
|
|
|
187 |
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Total revenues |
|
|
9,163 |
|
|
|
9,682 |
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|
|
17,162 |
|
|
|
18,898 |
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Operating
expenses: |
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Cost of sales (including finite-lived intangible |
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asset amortization) |
|
|
728 |
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|
|
1,327 |
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|
|
1,296 |
|
|
|
1,880 |
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Research and development, including stock-based |
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compensation of $1,949, $1,903, $4,125 and $3,671,
respectively |
|
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57,301 |
|
|
|
12,637 |
|
|
|
112,482 |
|
|
|
24,659 |
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Selling, general and administrative, including stock-based |
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|
|
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compensation of $2,309, $1,863, $4,565 and $3,506,
respectively |
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14,113 |
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|
|
14,263 |
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|
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28,801 |
|
|
|
28,373 |
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Impairment loss on buildings |
|
1,600 |
|
|
|
- |
|
|
|
1,600 |
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- |
|
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Total operating expenses |
|
|
73,742 |
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|
|
28,227 |
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|
|
144,179 |
|
|
|
54,912 |
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|
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Loss from
operations |
|
|
(64,579 |
) |
|
|
(18,545 |
) |
|
|
(127,017 |
) |
|
|
(36,014 |
) |
|
|
Interest
expense |
|
|
(5,125 |
) |
|
|
(5,164 |
) |
|
|
(10,256 |
) |
|
|
(10,281 |
) |
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Interest and
other income, net |
|
|
633 |
|
|
|
691 |
|
|
|
1,591 |
|
|
|
1,480 |
|
|
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Net
loss |
|
$ |
(69,071 |
) |
|
$ |
(23,018 |
) |
|
$ |
(135,682 |
) |
|
$ |
(44,815 |
) |
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|
|
|
|
|
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|
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Net loss per
common share, basic and diluted |
|
$ |
(0.65 |
) |
|
$ |
(0.22 |
) |
|
$ |
(1.27 |
) |
|
$ |
(0.42 |
) |
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Shares used
in computing net loss per common share, basic |
|
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|
|
|
|
|
|
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and diluted |
|
|
107,073 |
|
|
|
106,272 |
|
|
|
106,804 |
|
|
|
106,164 |
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As of |
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As of |
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Consolidated Balance Sheet Data |
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June 30, 2020 |
|
December 31, 2019 |
|
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(In
thousands) |
|
|
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|
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(Unaudited) |
|
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Cash and investments |
|
|
|
$ |
201,866 |
|
|
$ |
271,659 |
|
|
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Property and equipment, net |
|
|
|
|
11,524 |
|
|
|
14,047 |
|
|
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Goodwill |
|
|
|
|
44,543 |
|
|
|
44,543 |
|
|
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Other intangible assets |
|
|
|
|
18,833 |
|
|
|
19,716 |
|
|
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Total assets |
|
|
|
|
322,540 |
|
|
|
417,715 |
|
|
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Current and long-term debt |
|
|
|
|
245,264 |
|
|
|
245,183 |
|
|
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Accumulated deficit |
|
|
|
|
(1,477,126 |
) |
|
|
(1,341,444 |
) |
|
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Total stockholders' equity/(deficit) |
|
|
(10,687 |
) |
|
|
117,101 |
|
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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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