Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported
financial results for the three months ended June 30, 2024 and
provided an update on key corporate milestones.
“This past quarter has resulted in important
progress for the company,” said Mike Exton, Ph.D., Lexicon’s chief
executive officer and director.
“We believe our novel set of commercial and
pipeline opportunities, derived from our unique genomics target
discovery platform Genome5000, have the potential to transform our
company and significantly improve the healthcare treatment
landscape in their respective therapeutic areas. Entering the
second half of 2024, our first and most important priority will be
closely evaluating our business strategy, resources and goals to
ensure we are optimally positioned to promote the long-term success
and growth of Lexicon,” continued Dr. Exton.
Second Quarter 2024 Pipeline
Highlights
INPEFA (sotagliflozin) for Heart
Failure
- The INPEFA launch in heart failure
continues to progress and market access discussions remain ongoing.
Net sales for the quarter were $1.6 million.
ZYNQUISTA (sotagliflozin) for Type 1
Diabetes
- Lexicon resubmitted its NDA for
ZYNQUISTA as an adjunct to insulin in adults with type 1 diabetes
and CKD on June 20, 2024. FDA notified the company that it
considers the resubmission to be a complete response to its 2019
action letter regarding the NDA and provided a PDUFA goal date of
December 20, 2024. Preparations are underway for an early 2025
launch.
Sotagliflozin for HCM
- Lexicon has commenced the SONATA
Phase 3 study of sotagliflozin in HCM, with multiple sites open for
recruitment.
LX9211 for DPNP
- Patient enrollment remains on track
in the PROGRESS Phase 2b dose optimization study of LX9211 in DPNP.
LX9211 has the potential to become the first 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
- Utilizing Lexicon’s unique Genome
5000 targeting program, the company selected ACSL5-inhibitor
LX9851, a novel, oral development candidate for obesity and weight
management, for further preclinical development and is commencing
IND-enabling studies.
Publications and Data
Lexicon had a significant presence at recent
medical meetings including the 84th Scientific Sessions of the
American Diabetes Association (ADA) in June 2024 and the Annual
Congress of the Heart Failure Association of the European Society
of Cardiology (ESC) in May 2024, as well as publications in
Diabetes Care, JACC and Journal of Managed Care + Specialty
Pharmacy (JMCP).
Second Quarter 2024 Financial
Highlights
Revenues: Revenues for the
second quarter of 2024 increased to $1.6 million from $0.3 million
for the corresponding period from 2023, reflecting the continued
commercialization of INPEFA.
Research and Development (R&D)
Expenses: Research and development expenses for the second
quarter of 2024 increased to $17.6 million from $14.5 million for
the corresponding period in 2023 primarily due to higher external
clinical research expense, salaries and benefits.
Selling, General and Administrative
(SG&A) Expenses: Selling, general and administrative
expenses for the second quarter of 2024 increased to $39.2 million
from $30.0 million for the corresponding period in 2023. The
increase in 2024 reflects the significant investment in the
commercial launch of INPEFA, including sales force and related
marketing costs.
Net Loss: Net loss for the
second quarter of 2024 was $53.4 million, or $0.17 per share, as
compared to a net loss of $44.9 million, or $0.22 per share, in the
corresponding period in 2023. For the second quarters of 2024 and
2023, net loss included non-cash, stock-based compensation expense
of $4.9 million and $3.8 million, respectively.
Cash and Investments: As of
June 30, 2024, Lexicon had $310.0 million in cash and investments,
as compared to $170.0 million as of December 31, 2023, reflecting
the company’s March 2024 equity financing.
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 7023126. 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 June 30, |
|
Six Months Ended June 30, |
|
(In thousands, except per share data) |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
| |
|
(Unaudited) |
|
(Unaudited) |
|
Revenues: |
|
|
|
|
|
|
|
|
|
Net product revenue |
|
$ |
1,617 |
|
|
$ |
291 |
|
|
$ |
2,710 |
|
|
$ |
291 |
|
|
Royalties and other revenue |
|
|
30 |
|
|
|
26 |
|
|
|
67 |
|
|
|
49 |
|
| Total
revenues |
|
|
1,647 |
|
|
|
317 |
|
|
|
2,777 |
|
|
|
340 |
|
| Operating
expenses: |
|
|
|
|
|
|
|
|
|
Cost of sales |
|
|
166 |
|
|
|
8 |
|
|
|
197 |
|
|
|
8 |
|
|
Research and development, including stock-based compensation of
$1,679, $1,302, $3,273 and $2,505, respectively |
|
|
17,643 |
|
|
|
14,541 |
|
|
|
32,015 |
|
|
|
26,567 |
|
|
Selling, general and administrative, including stock-based
compensation of $3,180, $2,513, $5,888 and $4,725,
respectively |
|
|
39,192 |
|
|
|
30,008 |
|
|
|
71,252 |
|
|
|
49,147 |
|
|
Total operating expenses |
|
|
57,001 |
|
|
|
44,557 |
|
|
|
103,464 |
|
|
|
75,722 |
|
| Loss from
operations |
|
|
(55,354 |
) |
|
|
(44,240 |
) |
|
|
(100,687 |
) |
|
|
(75,382 |
) |
| Interest and
other expense |
|
|
(2,211 |
) |
|
|
(1,960 |
) |
|
|
(7,159 |
) |
|
|
(3,781 |
) |
| Interest
income and other, net |
|
|
4,136 |
|
|
|
1,296 |
|
|
|
6,020 |
|
|
|
2,325 |
|
| Net
loss |
|
$ |
(53,429 |
) |
|
$ |
(44,904 |
) |
|
$ |
(101,826 |
) |
|
$ |
(76,838 |
) |
| |
|
|
|
|
|
|
|
|
| Net loss per
common share, basic and diluted |
|
$ |
(0.17 |
) |
|
$ |
(0.22 |
) |
|
$ |
(0.37 |
) |
|
$ |
(0.39 |
) |
| |
|
|
|
|
|
|
|
|
| Weighted
average common shares outstanding, basic and diluted |
|
|
310,836 |
|
|
|
204,783 |
|
|
|
278,113 |
|
|
|
196,942 |
|
| |
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
| |
|
As of |
|
As of |
|
|
|
|
|
Consolidated Balance Sheet Data |
|
June 30, 2024 |
|
December 31, 2023 |
|
|
|
|
| (In
thousands) |
|
|
|
|
|
|
|
|
| Cash and
investments |
|
$ |
309,964 |
|
|
$ |
170,026 |
|
|
|
|
|
| Property and
equipment, net |
|
|
1,954 |
|
|
|
1,987 |
|
|
|
|
|
|
Goodwill |
|
|
44,543 |
|
|
|
44,543 |
|
|
|
|
|
| Total
assets |
|
|
373,356 |
|
|
|
229,429 |
|
|
|
|
|
| Long-term
debt, net |
|
|
99,499 |
|
|
|
99,508 |
|
|
|
|
|
| Accumulated
deficit |
|
|
(1,868,665 |
) |
|
|
(1,766,839 |
) |
|
|
|
|
| Total
stockholders' equity |
|
|
239,980 |
|
|
|
93,110 |
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
For Investor and Media Inquiries:Lisa
DeFrancescoLexicon Pharmaceuticals, Inc.lexinvest@lexpharma.com
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