Lexicon Pharmaceuticals Reports First Quarter 2021 Financial Results and Provides Clinical Update
May 06 2021 - 4:05PM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported
financial results for the three months ended March 31, 2021 and
provided an update on key milestones.
“We continue to enroll patients in our two
proof-of-concept Phase 2 clinical studies for LX9211 in neuropathic
pain and look forward to results from these studies by the end of
the year,” said Lonnel Coats, Lexicon’s president and chief
executive officer. “We are also very pleased with the regulatory
feedback received from the FDA on sotagliflozin in heart failure
and we are moving expeditiously forward with a planned NDA filing
in that indication this year.”
First Quarter Highlights
LX9211
- Patient enrollment continued in
RELIEF-DPN-1, a Phase 2 clinical study of LX9211 for the treatment
of diabetic peripheral neuropathic pain. Enrollment is expected to
total approximately 300 patients at approximately 40 clinical
sites.
- Patient enrollment continued in
RELIEF-PHN 1, a Phase 2 clinical study of LX9211 for the treatment
of post-herpetic neuralgia. Enrollment is expected to total
approximately 74 patients at approximately 20 clinical sites.
Sotagliflozin
- U.S. Food and Drug Administration
(FDA) provided regulatory feedback that the results of the SOLOIST
and SCORED Phase 3 clinical studies can support a new drug
application (NDA) submission for an indication to reduce the risk
of cardiovascular death, hospitalization for heart failure, and
urgent visits for heart failure in adult patients with type 2
diabetes with either worsening heart failure or additional risk
factors for heart failure.
2021 Anticipated Milestones and
Events
- NDA filing for sotagliflozin in
heart failure.
- Active efforts to secure strategic
alliance for sotagliflozin in heart failure.
- Phase 2 study results from
RELIEF-DPN-1 for LX9211 in diabetic peripheral neuropathic
pain.
- Phase 2 study results from
RELIEF-PHN-1 for LX9211 in post-herpetic neuralgia.
- Additional publications for
sotagliflozin and LX9211.
First Quarter 2021 Financial
Highlights
Revenues: Revenues for the
three months ended March 31, 2021 were negligible as compared to
$8.0 million for the corresponding period in 2020, primarily due to
the absence of product revenues as a result of the sale of XERMELO
during the third quarter of 2020.
Research and Development (R&D)
Expenses: Research and development expenses for the three
months ended March 31, 2021 decreased to $12.6 million from $55.2
million for the corresponding period in 2020, primarily due to
decreases in external clinical development costs related to
sotagliflozin resulting from the completion of clinical
studies.
Selling, General and Administrative
(SG&A) Expenses: Selling, general and administrative
expenses for the three months ended March 31, 2021 decreased to
$8.3 million from $14.7 million for the corresponding period in
2020, primarily due to lower salaries and benefit costs as a result
of reductions in personnel in September 2020 and lower marketing
expenses.
Net Loss: Net loss for the
three months ended March 31, 2021 was $21.0 million, or $0.15 per
share, as compared to a net loss of $66.6 million, or $0.63 per
share, in the corresponding period in 2020. For the three months
ended March 31, 2021 and 2020, net income included non-cash,
stock-based compensation expense of $2.9 million and $4.4 million,
respectively.
Cash and Investments: As of
March 31, 2021, Lexicon had $141.4 million in cash and investments,
as compared to $152.3 million as of December 31, 2020.
Conference Call and Webcast
Information
Lexicon management will hold a live conference
call and webcast today at 5:00 pm ET / 4:00 pm CT 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 8456671. The live webcast and replay may be
accessed by visiting Lexicon’s website at www.lexpharma.com/events.
An archived version of the webcast will be available on the website
for 14 days.
About Lexicon
Pharmaceuticals
Lexicon is a 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. Lexicon advanced
one of these medicines to market and has a pipeline of promising
drug candidates in discovery and clinical and preclinical
development in neuropathic pain, heart failure, diabetes and
metabolism and other indications. For additional information,
please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking
statements,” including statements relating to Lexicon’s financial
position and long-term outlook on its business, including the
clinical development of, regulatory filings for, and potential
therapeutic and commercial potential of LX9211, sotagliflozin and
its other potential drug candidates. In addition, this press
release also contains forward looking statements relating to
Lexicon’s growth and future operating results, discovery and
development 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 conduct preclinical and clinical development and
obtain necessary regulatory approvals of LX9211, sotagliflozin 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, 2020, 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) |
2021 |
|
|
2020 |
|
|
(Unaudited) |
Revenues: |
|
|
|
|
|
Net product revenue |
$ |
- |
|
|
$ |
7,877 |
|
Collaborative agreements |
- |
|
|
8 |
|
Royalties and other revenue |
27 |
|
|
114 |
|
Total revenues |
27 |
|
|
7,999 |
|
Operating expenses: |
|
|
|
|
|
Cost of sales (including finite-lived intangible asset
amortization) |
- |
|
|
568 |
|
Research and development, including stock-based compensation |
|
|
|
|
|
of $1,286 and $2,176, respectively |
12,609 |
|
|
55,181 |
|
Selling, general and administrative, including stock-based
compensation |
|
|
|
|
|
of $1,565 and $2,256, respectively |
8,257 |
|
|
14,688 |
|
Total operating expenses |
20,866 |
|
|
70,437 |
|
Loss from operations |
(20,839 |
) |
|
(62,438 |
) |
Interest expense |
(167 |
) |
|
(5,131 |
) |
Interest and other income,
net |
48 |
|
|
958 |
|
Net loss |
$ |
(20,958 |
) |
|
$ |
(66,611 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share, basic and diluted |
$ |
(0.15 |
) |
|
$ |
(0.63 |
) |
|
|
|
|
|
|
Shares used in computing net
loss per common share, basic and diluted |
143,379 |
|
|
106,536 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated Balance
Sheet Data |
As of March 31, 2021 |
|
|
As of December 31, 2020 |
|
(In thousands) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
Cash and investments |
$ |
141,361 |
|
|
$ |
152,275 |
|
Property and equipment, net |
296 |
|
|
295 |
|
Goodwill |
44,543 |
|
|
44,543 |
|
Total assets |
193,260 |
|
|
203,788 |
|
Current and long-term debt |
11,660 |
|
|
11,646 |
|
Accumulated deficit |
(1,420,976 |
) |
|
(1,400,018 |
) |
Total stockholders' equity |
152,547 |
|
|
156,371 |
|
For Inquiries:
Chas SchultzExecutive Director, Corporate
Communications and Investor RelationsLexicon Pharmaceuticals(281)
863-3421cschultz@lexpharma.com
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