Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported
financial results for the three months ended September 30th, 2023
and provided an update on key corporate milestones.
“We achieved important milestones this quarter
in commercially launching INPEFA (sotagliflozin) in the U.S. for
the treatment of heart failure while simultaneously advancing
LX9211 into late-stage development for diabetic peripheral
neuropathic pain,” said Lonnel Coats, Lexicon’s chief executive
officer. “We saw increasing prescription demand and clinical
utilization for INPEFA throughout the third quarter notwithstanding
limited access, and are now beginning to see important formulary
wins, with some of the more notable becoming effective on November
1st. With additional formulary wins expected, coupled with
increasing uptake from a broadening base of priority physicians, we
are confident the momentum behind INPEFA will continue to
accelerate as we enter 2024.”
“We remain focused on showcasing the growing
breadth of INPEFA’s clinical evidence and strengthening value
proposition at major medical meetings, further demonstrating its
differentiated profile for heart failure patients.”
“We are also continuing to present data
regarding LX9211, for which we have commenced late-stage
development in diabetic peripheral neuropathic pain, with patient
enrollment expected to begin this quarter in a Phase 2b clinical
trial. We remain excited about the clinical profile of LX9211 and
believe it could become the first new, non-opioid drug for
neuropathic pain in over two decades – an area where new treatment
options are urgently needed. Our continued progress with the launch
of INPEFA coupled with the advancement of LX9211 into late-stage
development are both major milestones in Lexicon’s path to
fulfilling its mission of pioneering medicines that transform
patients’ lives.”
Third Quarter Highlights
INPEFA®
(sotagliflozin)
Launch Progress
- On June 26, Lexicon commenced the
U.S. commercial launch of INPEFA (sotagliflozin) for the treatment
of heart failure, with product made available in pharmacies and
sales representatives deployed across the U.S.
-
On October 9, Lexicon announced that Express Scripts, the pharmacy
benefits management (PBM) business of The Cigna Group's Evernorth,
determined that it would place INPEFA on its Premier Access and
Premier Performance national formularies for Medicare patients on
November 1, 2023. On November 1, Lexicon announced that Express
Scripts had also determined that it would place INPEFA on its Basic
and High Performance formularies for commercially insured patients
on that date. These placements provide access to INPEFA for Express
Scripts Medicare and commercial patients in plans that utilize
these formularies and who meet the parameters of INPEFA’s
FDA-approved indication.
Publications and Data
- On August 8, Lexicon announced that
a post hoc analysis of data from the SOLOIST-WHF Phase 3
outcomes study of sotagliflozin was published by the Journal
of the American College of Cardiology (JACC): Heart Failure. The
main endpoint of the analysis was first occurrence of
cardiovascular death or heart failure-related event
(hospitalizations or urgent care visits for heart failure) within
30 and 90 days after hospital discharge (not randomization) in the
subgroup of patients who began study treatment on or before
discharge. Treatment with sotagliflozin resulted in significant
relative risk reductions of approximately 50% for readmission for
non-fatal heart failure events and for the composite of
cardiovascular death and readmission for heart failure at 30- or
90-days following hospital discharge versus placebo.
-
On August 26, two analyses of clinical study results relating
to sotagliflozin and Lexicon-supported data were presented during
the European Society of Cardiology (ESC) Congress 2023 in
Amsterdam, the Netherlands. Bertram Pitt, M.D., FACC, professor of
medicine emeritus at the University of Michigan, School of
Medicine, Ann Arbor, MI conducted an oral presentation entitled
Mediators of the benefit of sotagliflozin in patients with
worsening heart failure in SOLOIST-WHF. In addition, Marc Bonaca,
M.D., M.P.H., University of Colorado Anschutz Medical Campus,
Aurora, CO presented a moderated ePoster entitled Temporal shift in
heart failure diagnoses among hospitalized patients within a large
US integrated health system.
-
On October 4, Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice
president and chief medical officer, conducted an oral presentation
entitled Temporal shift in heart failure medications prescribed to
hospitalised patients with and without diabetes in a large US
integrated health system at the 59th Annual Meeting of
European Association for the Study of Diabetes (EASD) in Hamburg,
Germany and online.
-
On October 8, Michael J. Davies, Ph.D., Lexicon’s executive
director of clinical development, presented a new analysis of
clinical trial data for sotagliflozin entitled Sotagliflozin
Reduces the Risk of Cardiovascular Events In Patients With Left
Ventricular Hypertrophy Without Hypertension: A Post Hoc Analysis
From SCORED was presented at the Heart Failure Society of America
(HFSA) Annual Scientific Meeting in Cleveland, Ohio.
LX9211
-
In June, Lexicon announced the planned advancement of
AAK1-inhibitor LX9211 into late-stage development in diabetic
peripheral neuropathic pain. During Q3, our teams have continued
the preparations for the Phase 2b dose optimization study, with the
first patient expected to be enrolled in early December 2023.
-
On September 7, Lexicon announced a series of presentations
relating to LX9211 occurring throughout the third and fourth
quarters. Data were or will be shared in four oral presentations
and one poster presentation at various global congresses, including
NeuPSIG 2023 International Congress on Neuropathic Pain, held
September 7-9 in Lisbon, Portugal; 33rd Annual Meeting of the
Diabetic Neuropathy Study Group (NeuroDiab), held September
28-October 1 in Thessaloniki, Greece; 59th Annual Meeting of
the European Association for the Study of Diabetes (EASD), held
October 2-6 in Hamburg, Germany and online; 17th Annual Pain
Therapeutics Summit (Arrowhead Conference), held October 19-20 in
San Diego, California; and 2nd World Brain Disorders and
Neuroscience Summit (BDNS), being held November 9-11 in Singapore
and online.
Third Quarter 2023 Financial
Highlights
Revenues: Revenues for the
third quarter of 2023 were $0.2 million, primarily from the recent
commercial launch of INPEFA. INPEFA net product revenues from
launch (late June) through September 30, 2023 total $0.4
million.
Research and Development (R&D)
Expenses: Research and development expenses for the third
quarter of 2023 increased to $17.6 million from $10.6 million for
the corresponding period in 2022, primarily due to higher
manufacturing costs and higher external research and development
expenses related to the LX9211 program, partially offset by lower
professional and consulting fees.
Selling, General and Administrative
(SG&A) Expenses: Selling, general and administrative
expenses for the third quarter of 2023 increased to $32.2 million
from $12.6 million for the corresponding period in 2022, primarily
due to increases in salaries and benefits, professional and
consulting costs and marketing costs relating to preparations for
the commercial launch of INPEFA.
Net Loss: Net loss for the
third quarter of 2023 was $50.5 million, or $0.21 per share, as
compared to a net loss of $23.4 million, or $0.13 per share, in the
corresponding period in 2022. For the third quarters of 2023 and
2022, net loss included non-cash, stock-based compensation expense
of $3.9 million and $2.6 million, respectively.
Cash and Investments: As of
September 30, 2023, Lexicon had $218.4 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 8:00 am ET / 7:00 am 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 2598226. 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.
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 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, 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 September 30, |
|
Nine Months Ended September 30, |
(In
thousands, except per share data) |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|
|
(Unaudited) |
|
(Unaudited) |
Revenues: |
|
|
|
|
|
|
|
|
Net product revenue |
|
$ |
148 |
|
|
$ |
- |
|
|
$ |
438 |
|
|
$ |
- |
|
Royalties and other revenue |
|
|
14 |
|
|
|
39 |
|
|
|
64 |
|
|
|
111 |
|
Total revenues |
|
|
162 |
|
|
|
39 |
|
|
|
502 |
|
|
|
111 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Cost of Sales |
|
|
7 |
|
|
|
- |
|
|
|
15 |
|
|
|
- |
|
Research and development, including stock-based |
|
|
|
|
|
|
|
|
compensation of $1,337, $939, $3,842
and $3,069, respectively |
|
|
17,558 |
|
|
|
10,557 |
|
|
|
44,125 |
|
|
|
38,839 |
|
Selling, general and administrative, including stock-based |
|
|
|
|
|
|
|
|
compensation of $2,561, $1,709,
$7,286, and $5,183, respectively |
|
|
32,228 |
|
|
|
12,577 |
|
|
|
81,375 |
|
|
|
31,754 |
|
Total operating expenses |
|
|
49,793 |
|
|
|
23,134 |
|
|
|
125,515 |
|
|
|
70,593 |
|
Loss from
operations |
|
|
(49,631 |
) |
|
|
(23,095 |
) |
|
|
(125,013 |
) |
|
|
(70,482 |
) |
Interest
expense |
|
|
(3,899 |
) |
|
|
(864 |
) |
|
|
(7,680 |
) |
|
|
(1,677 |
) |
Interest and
other income, net |
|
|
3,005 |
|
|
|
572 |
|
|
|
5,330 |
|
|
|
709 |
|
Net
loss |
|
$ |
(50,525 |
) |
|
$ |
(23,387 |
) |
|
$ |
(127,363 |
) |
|
$ |
(71,450 |
) |
|
|
|
|
|
|
|
|
|
Net loss per
common share, basic and diluted |
|
$ |
(0.21 |
) |
|
$ |
(0.13 |
) |
|
$ |
(0.60 |
) |
|
$ |
(0.45 |
) |
|
|
|
|
|
|
|
|
|
Shares used
in computing net loss per |
|
|
|
|
|
|
|
|
common share, basic and diluted |
|
|
244,925 |
|
|
|
174,904 |
|
|
|
213,112 |
|
|
|
157,984 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of |
|
As of |
|
|
|
|
Consolidated Balance Sheet Data |
|
September 30, 2023 |
|
December 31, 2022 |
|
|
|
|
(In
thousands) |
|
|
|
|
|
|
|
|
Cash and investments |
|
$ |
218,427 |
|
|
$ |
138,357 |
|
|
|
|
|
Property and equipment, net |
|
|
2,134 |
|
|
|
2,071 |
|
|
|
|
|
Goodwill |
|
|
44,543 |
|
|
|
44,543 |
|
|
|
|
|
Total assets |
|
|
276,479 |
|
|
|
194,299 |
|
|
|
|
|
Long-term debt, net of issuance costs |
|
|
99,265 |
|
|
|
48,579 |
|
|
|
|
|
Accumulated deficit |
|
|
(1,717,083 |
) |
|
|
(1,589,720 |
) |
|
|
|
|
Total stockholders' equity |
|
|
139,510 |
|
|
|
117,124 |
|
|
|
|
|
For Investor Inquiries:
Lexicon Investor RelationsLexicon
Pharmaceuticals, Inc.lexinvest@lexpharma.com
For Media Inquiries:
Alina KolomeyerLexicon Pharmaceuticals,
Inc.akolomeyer@lexpharma.com
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