Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported
financial results for the three months ended March 31, 2024 and
provided an update on key corporate milestones.
“We have made tremendous progress as a company
in the first quarter of 2024, both in our commercial launch and in
our deep and innovative research and development pipeline,” said
Lonnel Coats, Lexicon’s chief executive officer. “Lexicon has never
been stronger, and the company’s future has never been
brighter.”
“We continue to make progress on the INPEFA
heart failure launch, with the expansion of market access we expect
to begin around the middle of this year enabling an inflection in
the second half of the year,” said Jeffrey Wade, Lexicon’s
president and chief financial officer. “The first quarter also saw
significant strides in our product pipeline. We are advancing a
potential near-term, substantial market opportunity with a planned
mid-year resubmission of our New Drug Application (NDA) for
ZYNQUISTA as an adjunct to insulin in people with type 1 diabetes
and chronic kidney disease (CKD). We commenced the start-up of our
Phase 3 study of sotagliflozin in hypertrophic cardiomyopathy
(HCM), an area of high unmet need with very few treatment options,
with enrollment expected to begin around the middle of the year.
And enrollment remains on track in PROGRESS, a Phase 2b study of
LX9211 in diabetic peripheral neuropathic pain (DPNP), with the
potential for LX9211 become the first new, non-opioid drug approved
for neuropathic pain in over two decades.”
“Finally, our Genome5000™ gene knockout drug
discovery engine continues to produce with the selection of our
LX9851 development candidate for obesity and weight management, now
entering IND-enabling studies. We are well capitalized with our
recent successful financing, and we are committed to remaining
financially disciplined as we make targeted investments to execute
on these opportunities for growth and expansion in 2024 and
beyond.”
First Quarter 2024 Pipeline
Highlights
INPEFA (sotagliflozin) for Heart
Failure
- The INPEFA launch in heart failure
continues to progress, with favorable feedback from healthcare
providers and ongoing negotiations with payers regarding expanded
market access. Net sales for the quarter were $1.1 million
reflecting 63 percent growth from the previous quarter. Market
access remains at approximately 40% overall and is expected to
expand in the second half of 2024.
ZYNQUISTA (sotagliflozin) for Type 1
Diabetes
- Following recent feedback from the
FDA, Lexicon is preparing to resubmit its NDA for ZYNQUISTA as an
adjunct to insulin in people with type 1 diabetes and CKD, expected
mid-year 2024. Glycemic control is critical for patients with type
1 diabetes to manage the progression to CKD. It is estimated that
CKD impacts an estimated 20 to 25 percent of people with type 1
diabetes.
Sotagliflozin for HCM
- Lexicon is initiating a Phase 3
study of sotagliflozin in HCM, with an expected study start
mid-year 2024. It is estimated that approximately one million
patients suffer ongoing and persistent symptoms from HCM
that negatively impact their quality of life.
LX9211 for DPNP
- Patient enrollment remains on track
in the PROGRESS Phase 2b dose optimization study. The PROGRESS
study marks initiation of the late-stage development program for
AAK1 inhibitor LX9211, with the potential for LX9211 to become the
first new, non-opioid drug therapy approved in neuropathic pain in
more than 20 years. Topline data from the PROGRESS study is
anticipated in Q2 2025.
LX9851 for Obesity and Weight
Management
- Lexicon selected ACSL5-inhibitor
LX9851, a novel, oral development candidate for obesity and weight
management, and is commencing IND-enabling studies.
Publications and Data
Lexicon had a significant presence at recent
medical meetings including the American Society of Nephrology (ASN)
in January 2024, International Conference on Advanced Technologies
& Treatments for Diabetes in March 2024 and American College of
Cardiology in April 2024:
- Beta-Hydroxybutyrate Levels and
Risk of Diabetic Ketoacidosis in Adults with Type 1 Diabetes
Treated with Sotagliflozin.
- Sotagliflozin and Kidney Outcomes, Kidney Function, and
Albuminuria in T2DM and CKD: A Secondary Analysis of the SCORED
Trial
- Sotagliflozin, A Dual SGLT1 and
SGLT2 Inhibitor, in Patients with Type 1 Diabetes and Chronic
Kidney Disease: A Post-hoc Analysis of the inTandem3 Study.
- Sotagliflozin Reduces Stroke
Outcomes in Patients with Diabetes and Chronic Kidney Disease
- Sotagliflozin, a Dual SGLT 1 and 2
Inhibitor, Modulated Expression of Glucose Transport and
Inflammatory Proteins in Endothelial Cells following Angiotensin II
Stimulation
- Sotagliflozin, a First-in-Class
SGLT1/2 Inhibitor, Inhibits Clotting Potential in the Vessel via
Inhibition of Platelet Activation, Integrin Activation, and
Aggregation in Human Platelets
- Temporal Shift in Heart Failure
Medications Prescribed to Hospitalized Patients According to Sex
and Age. Results from Two Large US Integrated Health System
First Quarter 2024 Financial
Highlights
Revenues: Revenues for the
first quarter of 2024 were $1.1 million, primarily from the
commercialization of INPEFA.
Research and Development (R&D) Expenses:
Research and development expenses for the first quarter of 2024
increased to $14.4 million from $12.0 million for the corresponding
period in 2023, primarily due to higher external research and
development expenses.
Selling, General and Administrative
(SG&A) Expenses: Selling, general and administrative
expenses for the first quarter of 2024 increased to $32.1 million
from $19.1 million for the corresponding period in 2023. The
increase in 2024 reflects the significant investment in the
commercial launch of INPEFA, including salaries and benefits
associated with the addition of the INPEFA sales force and other
increased headcount as well as increased travel and marketing
costs.
Net Loss: Net loss for the
first quarter of 2024 was $48.4 million, or $0.20 per share, as
compared to a net loss of $31.9 million, or $0.17 per share, in the
corresponding period in 2023. For the first quarters of 2024 and
2023, net loss included non-cash, stock-based compensation expense
of $4.3 million and $3.4 million, respectively.
Cash and Investments: As of
March 31, 2024, Lexicon had $355.6 million in cash and
investments, as compared to $170.0 million as of December 31,
2023 reflecting the issuance of convertible preferred stock in
March 2024.
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 5993982. 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 INPEFA®
(sotagliflozin)
Discovered using Lexicon’s unique approach to
gene science, INPEFA® (sotagliflozin) is an oral inhibitor of two
proteins responsible for glucose regulation known as sodium-glucose
cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible
for glucose and sodium reabsorption by the kidney and SGLT1 is
responsible for glucose and sodium absorption in the
gastrointestinal tract. Sotagliflozin has been studied in multiple
patient populations encompassing heart failure, diabetes, and
chronic kidney disease in clinical studies involving approximately
20,000 patients.
INDICATION
INPEFA is indicated to reduce the risk of
cardiovascular death, hospitalization for heart failure, and urgent
heart failure visit in adults with:
- heart failure or
- type 2 diabetes mellitus, chronic
kidney disease, and other cardiovascular risk factors
IMPORTANT SAFETY
INFORMATION
Dosing: Assess renal function
and volume status and, if necessary, correct volume depletion prior
to initiation of INPEFA. INPEFA dosing for patients with
decompensated heart failure may begin when patients are
hemodynamically stable, including when hospitalized or immediately
upon discharge.
Contraindications: INPEFA is
contraindicated in patients with hypersensitivity to INPEFA or any
of its components.
Ketoacidosis: INPEFA increases
the risk of ketoacidosis in patients with type 1 diabetes mellitus
(T1DM). Type 2 diabetes Mellitus (T2DM) and pancreatic disorders
are also risk factors. The risk of ketoacidosis may be greater with
higher doses. There have been postmarketing reports of fatal events
of ketoacidosis in patients with type 2 diabetes using sodium
glucose transporter 2 (SGLT2) inhibitors. Before initiating INPEFA,
assess risk factors for ketoacidosis. Consider ketone monitoring in
patients with T1DM and consider ketone monitoring in others at risk
for ketoacidosis and educate patients on the signs/symptoms of
ketoacidosis. Patients receiving INPEFA may require monitoring and
temporary discontinuation of therapy in clinical situations known
to predispose to ketoacidosis. INPEFA is not indicated for glycemic
control.Assess patients who present with signs and symptoms of
metabolic acidosis or ketoacidosis, regardless of blood glucose
level. If suspected, discontinue INPEFA, evaluate, and treat
promptly. Monitor patients for resolution of ketoacidosis before
restarting INPEFA.
Volume Depletion: INPEFA can
cause intravascular volume depletion which may sometimes manifest
as symptomatic hypotension or acute transient changes in
creatinine. There have been post-marketing reports of acute kidney
injury, some requiring hospitalization and dialysis, in patients
with type 2 diabetes mellitus receiving SGLT2 inhibitors. Patients
with impaired renal function (eGFR < 60 mL/min/1.73 m2), elderly
patients, or patients on loop diuretics may be at increased risk
for volume depletion or hypotension. Before initiating INPEFA in
patients with one or more of these characteristics, assess volume
status and renal function, and monitor for signs and symptoms of
hypotension during therapy.
Urosepsis and Pyelonephritis:
Treatment with SGLT2 inhibitors, including INPEFA, increases the
risk for urinary tract infections. Serious urinary tract infections
including urosepsis and pyelonephritis requiring hospitalization
have been reported. Evaluate patients for signs and symptoms of
urinary tract infections and treat promptly.
Hypoglycemia with Concomitant Use with
Insulin and Insulin Secretagogues: Insulin and insulin
secretagogues are known to cause hypoglycemia. INPEFA may increase
the risk of hypoglycemia when combined with insulin or an insulin
secretagogue. Therefore, a lower dose of insulin or insulin
secretagogue may be required to minimize the risk of hypoglycemia
when used with INPEFA.
Necrotizing Fasciitis of the Perineum
(Fournier’s Gangrene): Reports of Fournier’s Gangrene, a
rare but serious and life-threatening necrotizing infection
requiring urgent surgical intervention, have been identified in
post-marketing surveillance in patients with diabetes mellitus
receiving SGLT2 inhibitors. Assess patients who present with pain,
tenderness, erythema, or swelling in the genital or perineal area,
along with fever or malaise. If suspected, start treatment
immediately with broad-spectrum antibiotics and, if necessary,
surgical debridement. Discontinue INPEFA, closely monitor patient
signs and symptoms, and provide appropriate alternative therapy for
heart failure.
Genital Mycotic Infections:
INPEFA increases the risk of genital mycotic infections. Monitor
and treat as appropriate.
Urinary Glucose Test and
1,5-anhydroglucitol (1,5-AG) Assay: these are not reliable
for patients taking SGLT2 inhibitors. Use alternative testing
methods to monitor glucose levels.
Common Adverse Reactions: the
most commonly reported adverse reactions (incidence ≥ 5%) were
urinary tract infection, volume depletion, diarrhea, and
hypoglycemia.
Drug Interactions:
- Digoxin: Monitor
patients appropriately as there is an increase in the exposure of
digoxin when coadministered with INPEFA 400 mg.
- Uridine
5'-diphospho-glucuronosyltransferase (UGT) Inducer: The
coadministration of rifampicin, an inducer of UGTs, with
sotagliflozin resulted in a decrease in the exposure of
sotagliflozin.
- Lithium:
Concomitant use of an SGLT2 inhibitor with lithium may decrease
serum lithium concentrations. Monitor serum lithium concentration
more frequently during INPEFA initiation and with dosage
changes.
Use in Specific
Populations:
- Pregnancy and
Lactation: INPEFA is not recommended during the second and
third trimesters of pregnancy, nor while breastfeeding.
- Geriatric Use: No
INPEFA dosage change is recommended based on age. No overall
differences in efficacy were detected between these patients and
younger patients, and other reported clinical experience has not
identified differences in responses between the elderly and younger
patients, but greater sensitivity of some older individuals cannot
be ruled out. Elderly patients may be at increased risk for volume
depletion adverse reactions, including hypotension.
- Renal Impairment:
INPEFA was evaluated in patients with chronic kidney disease (eGFR
25 to 60 mL/min/1.73 m2) and in patients with heart failure
with eGFR < 60 mL/min/1.73 m2. The safety profile of
INPEFA across eGFR subgroups in these studies was consistent with
the known safety profile. There was an increase in volume-related
adverse events (e.g., hypotension, dizziness) in patients with eGFR
< 30 mL/min/1.73m2 relative to the overall safety
population. Efficacy and safety studies with INPEFA did not enroll
patients with an eGFR less than 25 mL/min/1.73 m2 or on dialysis.
After starting therapy in the studies, patients were discontinued
if eGFR fell below 15 mL/min/1.73 m2 or were initiated on chronic
dialysis.
- Hepatic
Impairment: INPEFA is not recommended in patients with
moderate or severe hepatic impairment.
Click here for full Prescribing Information.
https://www.lexpharma.com/inpefa-US-PI.pdf
About Lexicon
Pharmaceuticals
Lexicon is a biopharmaceutical company with a
mission of pioneering medicines that transform patients’ lives.
Through the Genome5000™ program, Lexicon’s unique genomics target
discovery platform, 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 has advanced
multiple 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 commercialization
of its approved products and the clinical development of,
regulatory filings for, and potential therapeutic and commercial
potential of its other drug candidates. 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 its approved products,
successfully conduct preclinical and clinical development and
obtain necessary regulatory approvals of its other 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 approved products and other 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, 2023, 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) |
2024 |
|
2023 |
|
(Unaudited) |
Revenues: |
|
|
|
Net product revenue |
$ |
1,093 |
|
$ |
— |
Royalties and other revenue |
37 |
|
24 |
Total revenues |
1,130 |
|
24 |
Operating expenses: |
|
|
|
Cost of sales |
31 |
|
— |
Research and development, including stock-based compensation of
$1,594 and $1,203, respectively |
14,372 |
|
12,026 |
Selling, general and administrative, including stock-based
compensation of $2,708 and $2,212, respectively |
32,060 |
|
19,140 |
Total operating expenses |
46,463 |
|
31,166 |
Loss from operations |
(45,333) |
|
(31,142) |
Interest and other
expense |
(4,948) |
|
(1,821) |
Interest income and other,
net |
1,884 |
|
1,029 |
Net loss |
$ |
(48,397) |
|
$ |
(31,934) |
|
|
|
|
Net loss per common share, basic and diluted |
$ |
(0.20) |
|
$ |
(0.17) |
|
|
|
|
Shares used in computing net loss per common share, basic and
diluted |
245,390 |
|
189,014 |
|
|
|
|
|
|
|
|
|
|
|
|
|
As of |
|
As of |
Consolidated Balance
Sheet Data |
March 31, 2024 |
|
December 31, 2023 |
(In thousands) |
|
|
|
Cash and investments |
$ |
355,598 |
|
$ |
170,026 |
Property and equipment,
net |
1,843 |
|
1,987 |
Goodwill |
44,543 |
|
44,543 |
Total assets |
417,219 |
|
229,429 |
Long-term debt, net |
99,874 |
|
99,508 |
Accumulated deficit |
(1,815,236) |
|
(1,766,839) |
Total stockholders'
equity |
288,867 |
|
93,110 |
|
|
|
|
For Investor Inquiries:Lisa
DeFrancesco Lexicon Pharmaceuticals,
Inc.lexinvest@lexpharma.com
For Media Inquiries:Alina
CocuzzaLexicon Pharmaceuticals, Inc.acocuzza@lexpharma.com
Lexicon Pharmaceuticals (NASDAQ:LXRX)
過去 株価チャート
から 4 2024 まで 5 2024
Lexicon Pharmaceuticals (NASDAQ:LXRX)
過去 株価チャート
から 5 2023 まで 5 2024