Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported
financial results for the three months ended December 31, 2023 and
provided an update on key corporate milestones.
“2023 was a pivotal year for Lexicon,” said
Lonnel Coats, Lexicon’s chief executive officer. “We launched
INPEFA within weeks of receiving U.S. FDA approval with a broad
label for heart failure, while in parallel continuing the
advancement of our innovative research and development
pipeline.”
“In the fourth quarter, we saw continued
progress on the launch of INPEFA and began to see increased
prescriber demand and important formulary wins, which we expect to
accelerate in the first half of 2024. We advanced LX9211 into
late-stage development for diabetic peripheral neuropathic pain
(DPNP), with the potential to become the first new, non-opioid drug
approved for neuropathic pain in over two decades.”
“We are preparing for Phase 3 development of
sotagliflozin in hypertrophic cardiomyopathy (HCM), an area of high
unmet need with very few treatments in development. And following
recent feedback from FDA, we are preparing to resubmit our New Drug
Application (NDA) for sotagliflozin as an adjunct to insulin
therapy in patients with type 1 diabetes and chronic kidney
disease. Our research and development engine also continues to
produce, and we are conducting preclinical development on an oral
small molecule compound for obesity and weight management. With
these opportunities and the support from shareholders in our recent
successful financing, Lexicon is well positioned for growth and
expansion in 2024 and beyond.”
Fourth Quarter Highlights
INPEFA®
(sotagliflozin)
Launch Progress
- INPEFA was placed on the
formularies of multiple important Medicare and commercial plans
during the fourth quarter, including Express Scripts’ Premier
Access and Premier Performance national formularies for Medicare
patients and Basic and High Performance formularies for
commercially insured patients.
Publications and Data
- 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 at the Heart Failure Society of
America (HFSA) Annual Scientific Meeting in Cleveland, Ohio.
- On November 12, 2023, Lexicon had a
significant presence and conducted multiple presentations related
to INPEFA at the American Heart Association Scientific Sessions
2023, including one oral presentation highlighting the early
clinical benefit of INPEFA for heart failure and atherosclerotic
events and another focusing on cost-effectiveness metrics
associated with the use of INPEFA.
LX9211
- In December, patient enrollment
began in the PROGRESS Phase 2b dose optimization study and is
progressing well. The PROGRESS study marks initiation of the
late-stage development program for AAK1 inhibitor LX9211, with
potential 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 2Q 2025.
- Data relating
to LX9211 were shared at various global congresses during the
fourth quarter, including the 33rd Annual Meeting of the
Diabetic Neuropathy Study Group (NeuroDiab), held September
28-October 1 in Thessaloniki, Greece; the 59th Annual Meeting
of the European Association for the Study of Diabetes (EASD), held
October 2-6 in Hamburg, Germany and online; the 17th Annual
Pain Therapeutics Summit (Arrowhead Conference), held October 19-20
in San Diego, California; and the 2nd World Brain Disorders
and Neuroscience Summit (BDNS), held November 9-11 in Singapore and
online.
Additional Pipeline
Opportunities
- Preparations are underway for Phase
3 development of sotagliflozin in HCM.
- Following recent feedback from FDA,
preparations are underway to resubmit Lexicon’s NDA for
sotagliflozin as an adjunct to insulin therapy in patients with
type 1 diabetes and chronic kidney disease.
- As part of Lexicon’s ongoing
discovery efforts, the company is advancing preclinical development
of a novel oral compound for obesity and weight management.
Fourth Quarter 2023 Financial
Highlights
Unless otherwise stated, all comparisons are for
the fourth quarter and full year of 2023 compared to the fourth
quarter and full year of 2022.
Revenues: Revenues for the
fourth quarter and full year of 2023 were $0.7 million and $1.2
million, respectively, primarily from the commercialization of
INPEFA.
Research and Development (R&D)
Expenses: Research and development expenses for the fourth
quarter of 2023 increased to $14.8 million from $14.0 million for
the corresponding period in 2022. Full-year research and
development expenses increased to $58.9 million in 2023 from $52.8
million for the corresponding period in 2022, primarily due to
higher manufacturing costs, partially offset by lower professional
and consulting fees related to the prior year NDA resubmission for
heart failure.
Selling, General and Administrative
(SG&A) Expenses: Selling, general and administrative
expenses for the fourth quarter of 2023 increased to $32.6 million
from $16.3 million in 2022 and for the full-year 2023 increased to
$114.0 million from $48.1 million in 2022. The increase in 2023 is
primarily due to the significant investment in the commercial
launch of INPEFA, including higher salaries and benefits of the new
sales force and other increased headcount, higher travel, and
higher marketing costs.
Net Loss: Net loss for the
fourth quarter of 2023 was $48.2 million, or $0.20 per share, as
compared to a net loss of $30.5 million, or $0.16 per share, in the
corresponding period in 2022. For the fourth quarters of 2023 and
2022, net loss included non-cash, stock-based compensation expense
of $3.2 million and $3.3 million, respectively. Net loss for the
full year was $175.6 million, or $0.79 per share, in 2023 as
compared to a net loss of $101.9 million, or $0.62 per share, in
the corresponding period in 2022. For the full years of 2023 and
2022, net loss included non-cash, stock-based compensation expense
of $14.3 million and $11.5 million, respectively.
Cash and Investments: As of
December 31, 2023, Lexicon had $170.0 million in cash and
investments, as compared to $138.4 million as of December 31,
2022.
Lexicon 2024 Investor Day – April 22, 2024 In
lieu of a year-end earnings conference call, Lexicon plans to hold
an Investor Day on April 22, 2024. The event will be webcast live
on Lexicon’s website at www.lexpharma.com/events. The agenda will
include a business and regulatory update, with participation from
multiple physician experts in the areas of cardiometabolic
disorders, HCM, type 1 diabetes and diabetic peripheral neuropathic
pain.
For Lexicon’s latest investor presentation, please visit
https://www.lexpharma.com/investors.
Planned Participation in Upcoming
Investor Conferences:
- Leerink Partners Global Biopharma
Conference March 12
- Needham 23rd Annual Virtual
Healthcare Conference on April 8-11
- Piper Sandler Virtual
Cardiovascular Day on April 10
- Piper Sandler Spring Biopharma
Symposium on April 16-17
These events will be webcast live on Lexicon’s
website at www.lexpharma.com/events.
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 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 December 31, |
|
Years Ended December 31, |
|
(In thousands, except per share data) |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
(Unaudited) |
|
(Unaudited) |
|
Revenues: |
|
|
|
|
|
|
|
|
|
Net product revenue |
|
$ |
672 |
|
|
$ |
- |
|
|
$ |
1,110 |
|
|
$ |
- |
|
|
Royalties and other revenue |
|
|
30 |
|
|
|
28 |
|
|
|
94 |
|
|
|
139 |
|
|
Total revenues |
|
|
702 |
|
|
|
28 |
|
|
|
1,204 |
|
|
|
139 |
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Cost of
sales |
|
|
70 |
|
|
|
- |
|
|
|
85 |
|
|
|
- |
|
|
Research and development, including stock-based |
|
|
|
|
|
|
|
|
|
compensation of $1,297, $1,184, $5,139 and $4,253,
respectively |
|
|
14,762 |
|
|
|
13,977 |
|
|
|
58,887 |
|
|
|
52,816 |
|
|
Selling, general and administrative, including stock-based |
|
|
|
|
|
|
|
|
|
compensation of $1,915, $2,084, $9,201, and $7,267,
respectively |
|
|
32,607 |
|
|
|
16,329 |
|
|
|
113,982 |
|
|
|
48,083 |
|
|
Total operating expenses |
|
|
47,439 |
|
|
|
30,306 |
|
|
|
172,954 |
|
|
|
100,899 |
|
|
Loss from
operations |
|
|
(46,737 |
) |
|
|
(30,278 |
) |
|
|
(171,750 |
) |
|
|
(100,760 |
) |
|
Interest
expense |
|
|
(3,909 |
) |
|
|
(1,103 |
) |
|
|
(11,589 |
) |
|
|
(2,780 |
) |
|
Interest and
other income, net |
|
|
2,402 |
|
|
|
887 |
|
|
|
7,732 |
|
|
|
1,596 |
|
|
Net
loss |
|
$ |
(48,244 |
) |
|
$ |
(30,494 |
) |
|
$ |
(175,607 |
) |
|
$ |
(101,944 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net loss per
common share, basic and diluted |
|
$ |
(0.20 |
) |
|
$ |
(0.16 |
) |
|
$ |
(0.79 |
) |
|
$ |
(0.62 |
) |
|
|
|
|
|
|
|
|
|
|
|
Shares used
in computing net loss per |
|
|
|
|
|
|
|
|
|
common share, basic and diluted |
|
|
244,925 |
|
|
|
188,726 |
|
|
|
221,130 |
|
|
|
165,733 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of |
|
As of |
|
|
|
|
|
Consolidated Balance Sheet Data |
|
December 31, 2023 |
December 31, 2022 |
|
|
|
|
(In
thousands) |
|
|
|
|
|
|
|
|
|
Cash and
investments |
|
$ |
170,026 |
|
|
$ |
138,357 |
|
|
|
|
|
|
Property and
equipment, net |
|
|
1,987 |
|
|
|
2,071 |
|
|
|
|
|
|
Goodwill |
|
|
44,543 |
|
|
|
44,543 |
|
|
|
|
|
|
Total
assets |
|
|
229,429 |
|
|
|
194,299 |
|
|
|
|
|
|
Long-term
debt, net |
|
|
99,508 |
|
|
|
48,579 |
|
|
|
|
|
|
Accumulated
deficit |
|
|
(1,765,327 |
) |
|
|
(1,589,720 |
) |
|
|
|
|
|
Total
stockholders' equity |
|
|
94,622 |
|
|
|
117,124 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For Investor Inquiries:
Lisa DeFrancesco Lexicon Pharmaceuticals,
Inc.lexinvest@lexpharma.com
For Media Inquiries:Alina
CocuzzaLexicon Pharmaceuticals, Inc.acocuzza@lexpharma.com
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