Lexicon Pharmaceuticals Reports First Quarter 2023 Financial Results and Provides Business Update
May 02 2023 - 4:00PM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported
financial results for the three months ended March 31, 2023 and
provided an update on key corporate milestones.
“Our NDA for sotagliflozin for the treatment of
heart failure is on track for its May 27th PDUFA action date,” said
Lonnel Coats, Lexicon’s chief executive officer. “With both
recently adopted medical treatment guidelines recommending the use
of SGLT inhibitors as a key pillar of heart failure treatment and
the unique data from our SOLOIST-WHF trial, we believe we have a
strong value proposition for clinical differentiation in the heart
failure market. Should we receive regulatory approval, we are
prepared to promptly launch in the United States in the first half
of 2023.”
“As we have previously shared, we continue
preparations to advance LX9211 into late-stage development in
neuropathic pain, supported by data from Phase 2 proof-of-concept
studies in diabetic peripheral neuropathic pain (DPN) and
postherpetic neuralgia (PHN), both completed in 2022, and expect
feedback from our interactions from the FDA in Q2.”
First Quarter Highlights
Sotagliflozin
- On March 4th, new analyses of
results from our SOLOIST-WHF Phase 3 outcomes study of
sotagliflozin were presented at the American College of
Cardiology’s 72nd Annual Scientific Session Together With
World Heart Federation’s World Congress of Cardiology in New
Orleans, Louisiana. The “Time to Clinical Benefit of
Sotagliflozin in People with Worsening Heart Failure in
SOLOIST-WHF” post hoc analysis examined the timing of
clinical benefit of sotagliflozin, defined as the first day post
randomization when the hazard ratio (HR) for risk for the primary
outcome of total number of cardiovascular deaths, hospitalizations
for heart failure, and urgent visits for heart failure was
statistically significant (p<0.05) and remained significant
throughout follow up. A subgroup analysis was also conducted in
patients with left ventricular ejection fraction (LVEF) < 50% or
≥ 50%. The analysis showed a statistically significant reduction in
the risk for the primary outcome on Day 27, or time to clinical
benefit of 27 days, in patients with worsening heart failure (WHF)
treated with sotagliflozin. Furthermore, these findings were
generally consistent across the LVEF range.
First Quarter 2022 Financial
Highlights
Research and Development (R&D)
Expenses: Research and development expenses for the first
quarter of 2023 decreased to $12.1 million from $14.9 million for
the corresponding period in 2022, primarily due to lower external
research development costs and professional and consulting fees in
2023 related to the preparations for the submission of our
application for regulatory approval to market sotagliflozin for
heart failure.
Selling, General and Administrative
(SG&A) Expenses: Selling, general and administrative
expenses for the first quarter of 2023 increased to $19.1 million
from $8.5 million for the corresponding period in 2022, primarily
due to increases in headcount and in professional and consulting
fees relating to preparations for the commercial launch of
sotagliflozin in heart failure.
Net Loss: Net loss for the
first quarter of 2023 was $31.9 million, or $0.17 per share, as
compared to a net loss of $23.5 million, or $0.16 per share, in the
corresponding period in 2022. For the first quarters of 2023 and
2022, net loss included non-cash, stock-based compensation expense
of $3.4 million and $2.8 million, respectively.
Cash and Investments: As of
March 31, 2023, Lexicon had $105.9 million in cash and investments,
as compared to $138.4 million as of December 31, 2022.
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 888-317-6003
and the conference ID for all callers is 2576268. 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 heart failure, neuropathic pain, 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 sotagliflozin, LX9211 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 sotagliflozin, LX9211 and
its other potential drug candidates on its anticipated timelines,
successfully commercialize any products for which it obtains
regulatory approval, 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, 2022, 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) |
2023 |
|
2022 |
|
(Unaudited) |
|
|
Revenues: |
|
|
|
|
|
Royalties and other revenue |
$ |
24 |
|
|
$ |
37 |
|
Operating expenses: |
|
|
|
|
|
Research and development, including stock-based compensation of
$1,203 and $1,032, respectively |
12,026 |
|
|
14,926 |
|
Selling, general and administrative, including stock-based
compensation of $2,212 and $1,740, respectively |
19,140 |
|
|
8,491 |
|
Total operating expenses |
31,166 |
|
|
23,417 |
|
Loss from operations |
(31,142 |
) |
|
(23,380 |
) |
Interest expense |
(1,821 |
) |
|
(110 |
) |
Interest and other income,
net |
1,029 |
|
|
14 |
|
Net loss |
$ |
(31,934 |
) |
|
$ |
(23,476 |
) |
|
|
|
|
|
|
Net loss per common share, basic and diluted |
$ |
(0.17 |
) |
|
$ |
(0.16 |
) |
|
|
|
|
|
|
Shares used in computing net loss per common share, basic and
diluted |
189,014 |
|
|
149,150 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of |
|
As of |
Consolidated Balance
Sheet Data |
March 31, 2023 |
|
December 31, 2022 |
(In thousands) |
|
|
|
|
|
Cash and investments |
$ |
105,937 |
|
|
$ |
138,357 |
|
Property and equipment, net |
2,207 |
|
|
2,071 |
|
Goodwill |
44,543 |
|
|
44,543 |
|
Total assets |
162,716 |
|
|
194,299 |
|
Long-term debt, net of issuance costs |
48,845 |
|
|
48,579 |
|
Accumulated deficit |
(1,621,654 |
) |
|
(1,589,720 |
) |
Total stockholders' equity |
88,046 |
|
|
117,124 |
|
|
|
|
|
|
|
For Investor Inquiries:
Carrie SiragusaLexicon Pharmaceuticals,
Inc.csiragusa@lexpharma.com
For Media Inquiries:
Alina Cocuzza (Kolomeyer)Lexicon
Pharmaceuticals, Inc.akolomeyer@lexpharma.com
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