Lexicon Pharmaceuticals Reports Third Quarter 2022 Financial Results And Provides Business Update
November 09 2022 - 4:01PM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported
financial results for the three months ended September 30, 2022 and
provided an update on key corporate milestones.
“Our mid-cycle review meeting with the FDA was
held this week for our NDA for sotagliflozin for the treatment of
heart failure, which remains on track for its PDUFA action date in
May 2023,” said Lonnel Coats, Lexicon’s chief executive officer.
“This past weekend, important data for sotagliflozin were presented
at two major medical conferences, notably including an oral
presentation at the American Heart Association Scientific Sessions
2022 on reduced cardiovascular mortality and hospital readmissions
for heart failure at 30- and 90-days post discharge in patients
hospitalized for worsening heart failure in the SOLOIST-WHF
trial.”
“This coming Monday, final data from our
successful RELIEF-DPN-1 study of LX9211 in painful diabetic
neuropathy will be presented at the 16th Annual Pain Therapeutics
Summit in Washington, D.C., which we will follow with a conference
call discussing the results and their importance in an area of
significant unmet need,” Mr. Coats continued. “Finally, we
completed enrollment earlier this quarter in our RELIEF-PHN-1 study
of LX9211 in post-herpetic neuralgia, from which we expect to
report top-line data before year-end.”
Third Quarter Highlights
Sotagliflozin
- The U.S. Food and Drug
Administration (FDA) accepted for review and filed Lexicon’s New
Drug Application (NDA) for sotagliflozin for the treatment of heart
failure. The FDA assigned a standard review for the NDA filing with
a Prescription Drug User Fee Act (PDUFA) target action date in May
2023.
- Two posters were presented at the
70th annual European Society of Cardiology Congress, highlighting
protein expression analyses comparing sotagliflozin, a dual SGLT1
and SGLT2 inhibitor, with a selective SGLT2 inhibitor in cell-based
models relative to inflammation and thrombosis.
- The first poster, “Sotagliflozin, a
Dual SGLT1/2 Inhibitor, Reduced Expression of Neutrophil
Degranulation Proteins During Endothelial Dysfunction Compared with
a Selective SGLT2 Inhibitor,” concluded that the favorable effects
of sotagliflozin on mechanisms of inflammation have implications
for ischemic disease, including myocardial infarction and
stroke.
- The second poster, “Sotagliflozin,
a Dual SGLT1/2 Inhibitor, Reduced Expression of Platelet Activators
During Endothelial Dysfunction Compared to Empagliflozin,”
concluded that the effects of dual SGLT1 and SGLT2 inhibition on
platelet activity may have implications for reduced
atherothrombotic risk.
- A manuscript entitled “Metabolic,
Intestinal, and Cardiovascular Effects of Sotagliflozin Compared
with Empagliflozin in Patients with Type 2 Diabetes: A Randomized,
Double-Blind Study” was published in the September issue of the
journal Diabetes Care. Results from the study showed significant
differences between the agents with respect to certain incremental
incretin levels following meals, particularly at breakfast.
Sotagliflozin significantly reduced postprandial glucose, insulin,
and glucose-dependent insulinotropic polypeptide (GIP) and
significantly increased glucagon-like peptide 1 (GLP-1), in each
case relative to empagliflozin and consistent with sotagliflozin’s
inhibition of intestinal SGLT-1. The favorable changes in these
measures were noted in the manuscript as having potential
implications for cardiovascular disease.
LX9211
- A poster was presented and an oral
presentation was given at the PAINWeek 2022 National Conference on
Pain Management. The poster and presentation, each titled “LX9211,
a Novel Therapeutic Approach to Treatment of Neuropathic Pain,”
described the mechanism of action of LX9211’s novel target,
adaptor-associated protein kinase 1 (AAK1), as well as results from
multiple preclinical models of neuropathic pain after treatment
with LX9211.
- A poster was presented at the IASP
World Congress on Pain, titled “Efficacy, Safety, and
Pharmacokinetics of LX9211 in the Treatment of Diabetic Peripheral
Neuropathic Pain (RELIEF-DPN-1),” outlining the study design,
baseline patient characteristics, and positive results of the
primary endpoint of the study.
Public Offering and Concurrent Private
Placement
- Lexicon completed a public offering
and concurrent private placement of common stock, with net proceeds
to the company of $94.3 million.
Third Quarter 2022 Financial
Highlights
Research and Development (R&D)
Expenses: Research and development expenses for the third
quarter of 2022 decreased to $10.6 million from $15.7 million for
the corresponding period in 2021, primarily due to lower clinical
external research expenses and professional and consulting
costs.
Selling, General and Administrative
(SG&A) Expenses: Selling, general and administrative
expenses for the third quarter of 2022 increased to $12.6 million
from $7.3 million for the corresponding period in 2021, primarily
due to increases in salaries and benefits, professional and
consulting costs and marketing costs relating to preparations for
the commercial launch of sotagliflozin.
Net Loss: Net loss for the
third quarter of 2022 was $23.4 million, or $0.13 per share, as
compared to a net loss of $23.1 million, or $0.16 per share, in the
corresponding period in 2021. For the third quarters of 2022 and
2021, net loss included non-cash, stock-based compensation expense
of $2.6 million and $2.7 million, respectively.
Cash and Investments: As of
September 30, 2022, Lexicon had $136.2 million in cash and
investments, as compared to $86.7 million as of December 31,
2021
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
888-886-7786 and the conference ID for all callers is 70766912. 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, 2021, 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 |
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Consolidated Statements of Operations Data |
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
(In thousands, except per share data) |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
(Unaudited) |
|
(Unaudited) |
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Royalties and other revenue |
|
$ |
39 |
|
|
$ |
23 |
|
|
$ |
111 |
|
|
$ |
284 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development, including stock-based compensation of
$939, $1,138, $3,069 and $3,608, respectively |
|
|
10,557 |
|
|
|
15,682 |
|
|
|
38,839 |
|
|
|
38,548 |
|
Selling, general and administrative, including stock-based
compensation of $1,709, $1,574, $5,183 and $4,741,
respectively |
|
|
12,577 |
|
|
|
7,303 |
|
|
|
31,754 |
|
|
|
23,496 |
|
Total operating expenses |
|
|
23,134 |
|
|
|
22,985 |
|
|
|
70,593 |
|
|
|
62,044 |
|
Loss from operations |
|
|
(23,095 |
) |
|
|
(22,962 |
) |
|
|
(70,482 |
) |
|
|
(61,760 |
) |
Interest expense |
|
|
(864 |
) |
|
|
(171 |
) |
|
|
(1,677 |
) |
|
|
(507 |
) |
Interest and other income, net |
|
|
572 |
|
|
|
11 |
|
|
|
709 |
|
|
|
120 |
|
Net loss |
|
$ |
(23,387 |
) |
|
$ |
(23,122 |
) |
|
$ |
(71,450 |
) |
|
$ |
(62,147 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share, basic and diluted |
|
$ |
(0.13 |
) |
|
$ |
(0.16 |
) |
|
$ |
(0.45 |
) |
|
$ |
(0.43 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing net
loss per common share, basic and diluted |
|
|
174,904 |
|
|
|
145,820 |
|
|
|
157,984 |
|
|
|
144,558 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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As of |
As of |
Consolidated Balance Sheet Data |
|
|
|
|
|
|
|
|
|
September 30, 2022 |
|
December 31, 2021 |
(In thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
Cash and investments |
|
|
|
|
|
|
|
|
|
$ |
136,203 |
|
|
$ |
86,743 |
|
Property and equipment, net |
|
|
|
|
|
|
|
|
|
|
932 |
|
|
|
1,176 |
|
Goodwill |
|
|
|
|
|
|
|
|
|
|
44,543 |
|
|
|
44,543 |
|
Total assets |
|
|
|
|
|
|
|
|
|
|
191,685 |
|
|
|
136,909 |
|
Long-term debt, net of issuance costs |
|
|
|
|
|
|
|
|
|
|
23,784 |
|
|
|
- |
|
Accumulated deficit |
|
|
|
|
|
|
|
|
|
|
(1,559,226 |
) |
|
|
(1,487,776 |
) |
Total stockholders' equity |
|
|
|
|
|
|
|
|
|
|
144,018 |
|
|
|
113,595 |
|
|
|
|
|
|
|
|
|
|
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For Inquiries:
Mike KellyLexicon Pharmaceuticals,
Inc.mkelly@lexpharma.com
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