Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical
company focused on the development and commercialization of
therapeutics for central nervous system (CNS) disorders, today
announced its financial results for the fourth quarter ended
December 31, 2023 and provided a corporate update.
“I am very proud of our accomplishments in 2023, including the
continued strong uptake of CAPLYTA. In the year ahead, we are
focused on continuing CAPLYTA’s momentum and advancing our
pipeline. We look forward to the upcoming CAPLYTA Phase 3 read outs
in adjunctive MDD and the potential to help a growing number of
patients,” said Dr. Sharon Mates, Chairman and CEO of
Intra-Cellular Therapies.
FINANCIAL HIGHLIGHTS:
- Net product sales
of CAPLYTA were $462.2 million for the full year 2023. This
represents an increase of 86% compared to 2022. This growth was
fueled by strong underlying prescription demand which grew 85%
year-over-year in 2023.
- For the fourth quarter 2023, CAPLYTA net product sales reached
$131.5 million representing a 50% increase over the fourth quarter
of 2022.
- Net loss for
the year ended December 31, 2023 was $139.7 million or $1.46
per share (basic and diluted) compared to a net loss of $256.3
million or $2.72 per share (basic and diluted) for the year ended
December 31, 2022. Net loss for the fourth quarter of 2023 was
$28.6 million compared to a net loss of $44.0 million for the same
period in 2022.
- Selling, general and administrative (SG&A) expenses were
$409.9 million for the year ended December 31, 2023, compared
to $358.8 million for the year ended December 31, 2022. This
increase is primarily due to an increase in commercialization,
marketing and advertising costs.
- Research and development (R&D) expenses were $180.1 million
for the year ended December 31, 2023, compared to $134.7
million for the year ended December 31, 2022. This increase is
primarily due to higher lumateperone clinical and non-clinical
project costs, and higher non-lumateperone project costs, including
the ITI-1284, ITI-214, and ITI-333 programs.
- Cash, cash equivalents, restricted cash and investment
securities totaled $499.7 million at December 31, 2023,
compared to $593.7 million at December 31, 2022.
Full Year 2024
Financial Outlook:
- CAPLYTA 2024 net product sales are
expected to be $645 to $675 million.
- SG&A expenses for the full year
2024 are expected to be $450 to $480 million, including
approximately $42.5 million of non-cash, share-based compensation
expense. SG&A guidance reflects our commitment to continue to
effectively and efficiently support CAPLYTA commercialization
through investments in our sales and marketing activities.
- R&D expenses for the full year
2024 are expected to be $215 to $240 million, including
approximately $20 million of non-cash, share-based compensation
expense. Our R&D guidance reflects investments to support our
broad pipeline. In 2024, we anticipate that a large portion of our
total R&D expenditures will be related to our lumateperone
development programs as we continue to explore the use of
lumateperone in additional patient populations.
|
2024 Guidance(in $ millions) |
|
low |
|
high |
CAPLYTA Net Product Sales
(GAAP) |
$645 |
|
$675 |
SG&A expenses (GAAP) |
$450 |
|
$480 |
R&D expenses (GAAP) |
$215 |
|
$240 |
COMMERCIAL HIGHLIGHTS
- Successfully
continued the launch of CAPLYTA for the treatment of bipolar
depression in adults. In 2023, CAPLYTA strong prescription demand
continued with 85% total prescription growth over 2022. In the
fourth quarter, total prescriptions of CAPLYTA increased 55% over
the same period in 2022, and 10% sequentially over the third
quarter of 2023.
- In 2023, we
continued to improve market access for CAPLYTA across all three
major channels. Our market access for CAPLYTA covers approximately
90% of commercially insured lives and greater than 99% of the
Medicare Part D and Medicaid lives.
- Our LytaLink patient and prescriber support program continues
to be very effective in supporting patient access to CAPLYTA.
CLINICAL HIGHLIGHTS
Lumateperone:
- Adjunctive MDD program: Studies 501, 502 and 505 are our global
Phase 3 clinical trials evaluating lumateperone 42 mg as an
adjunctive therapy to antidepressants for the treatment of major
depressive disorder. Study 501 is fully enrolled and most patients
have completed treatment. We allowed the small number of patients
who were in screening when we reached our previously determined
enrollment target to continue and be randomized to the double-blind
treatment phase of the study. As a result, we expect to report
topline results from Study 501 in April of this year. In addition,
we expect to report topline results from Study 502 late in the
second quarter of this year. Subject to those results, we continue
to anticipate filing a supplemental New Drug Application with the
FDA in the second half of 2024.
- Mixed Features program: In 2023, we reported robust positive
results from Study 403, our clinical trial evaluating lumateperone
in patients with major depressive disorder exhibiting mixed
features and patients with bipolar depression exhibiting mixed
features In this study, lumateperone 42 mg was statistically
significant on the primary endpoint of symptom reduction on the
Montgomery Asberg Depression Rating Scale (MADRS) for the combined
mixed features patient population of MDD and bipolar depression and
the individual patient populations of MDD with mixed features and
bipolar depression with mixed features. The robust effect sizes
ranged from 0.64 to 0.67. Lumateperone was generally safe and well
tolerated, with a side effect profile consistent with prior trials.
There were no notable changes in weight, body mass index or waist
circumference and no clinically relevant changes in metabolic
parameters. Last year, we presented results from Study 403 at
several medical conferences including the Psych Congress, the
European College of Neuropsychopharmacology Congress and the
American College of Neuropsychopharmacology annual meeting.
- Lumateperone pediatric program: We have commenced our
lumateperone pediatric program. This program includes an open-label
safety study in schizophrenia and bipolar disorder; a double-blind,
placebo-controlled study in bipolar depression and two
double-blind, placebo-controlled studies in irritability associated
with autism spectrum disorder. The patient enrollment in the
open-label safety study has commenced.
- Lumateperone Long Acting Injectable (LAI) formulation: The goal
of the program is to develop LAI formulations that are effective,
safe, and well-tolerated with treatment durations of one month or
longer. For our first LAI formulation, we have completed the
pre-clinical development and conducted a Phase 1 single ascending
dose study. We expect to initiate a Phase 1 single ascending dose
study with four additional formulations in the first half of
2024.
Other pipeline programs:
- ITI-1284-ODT-SL program: ITI-1284 is a deuterated form of
lumateperone, a new chemical entity formulated as an oral
disintegrating tablet for sublingual administration. In 2023, we
advanced several Phase 1 studies. We have initiated Phase 2
programs evaluating ITI-1284 in generalized anxiety disorder (GAD),
psychosis in Alzheimer’s disease, and agitation in Alzheimer’s
disease and anticipate commencing patient enrollment in the first
half of 2024.
- Phosphodiesterase type I inhibitor (PDE1) program: Our
portfolio of PDE1 inhibitors continues to advance clinical
development. Lenrispodun (ITI-214) Parkinson’s disease (PD)
program: Patient enrollment in our Phase 2 clinical trial is
ongoing. The objective of this study is to evaluate improvements in
motor symptoms in patients with PD. Changes in cognition and
inflammatory biomarkers are also being assessed. We expect to
complete patient enrollment in late 2024 with topline results
anticipated in the first half of 2025. ITI-1020 cancer
immunotherapy program: Our Phase 1 single ascending dose study in
healthy volunteers is progressing. The objective of this study is
to evaluate pharmacokinetics, safety, and tolerability of different
doses of ITI-1020.
- ITI-333 program: ITI-333, a 5-HT2A receptor antagonist and
μ-opioid receptor partial agonist, provides potential utility in
the treatment of opioid use disorder and pain. A multiple ascending
dose study and a positron emission tomography (PET) study are both
ongoing.
- ITI-1500 Non-Hallucinogenic Psychedelic Program: In 2023, we
introduced the ITI-1500 program. This program is focused on the
development of novel non-hallucinogenic psychedelics for the
treatment of mood, anxiety and other neuropsychiatric disorders
without the liabilities of known psychedelics, including the
hallucinogenic potential and risk for cardiac valvular pathologies.
Our lead product candidate in this program, ITI-1549, is advancing
through IND enabling studies and is expected to enter human testing
in late 2024 or early 2025.
Conference Call and Webcast Details
The Company will host a live conference call and webcast today
at 8:30 AM Eastern Time to discuss the Company’s
financial results and provide a corporate update. To attend the
live conference call by phone, please use this registration link
(https://register.vevent.com/register/BI4a916e3aa80448ae8e675216382f1cf2).
All participants must use the link to complete the online
registration process in advance of the conference call.
The live and archived webcast can be accessed under "Events
& Presentations" in the Investors section of the Company's
website at www.intracellulartherapies.com. Please log in
approximately 5-10 minutes prior to the event to register and to
download and install any necessary software.
CAPLYTA® (lumateperone) is indicated in adults for the
treatment of schizophrenia and for the treatment of depressive
episodes associated with bipolar I or II disorder (bipolar
depression) as monotherapy and as adjunctive therapy with lithium
or valproate.
Important Safety Information
Boxed Warnings:
- Elderly patients with dementia-related psychosis
treated with antipsychotic drugs are at an increased risk of death.
CAPLYTA is not approved for the treatment of patients with
dementia-related psychosis.
- Antidepressants increased the risk of suicidal thoughts
and behaviors in pediatric and young adults in short-term studies.
All antidepressant-treated patients should be closely monitored for
clinical worsening, and for emergence of suicidal thoughts and
behaviors. The safety and effectiveness of CAPLYTA have not been
established in pediatric patients.
Contraindications: CAPLYTA is contraindicated
in patients with known hypersensitivity to lumateperone or any
components of CAPLYTA. Reactions have included pruritus, rash
(e.g., allergic dermatitis, papular rash, and generalized rash),
and urticaria.
Warnings & Precautions: Antipsychotic drugs
have been reported to cause:
- Cerebrovascular Adverse Reactions in Elderly Patients
with Dementia-Related Psychosis, including stroke and
transient ischemic attack. See Boxed Warning above.
- Neuroleptic Malignant Syndrome (NMS), which is
a potentially fatal reaction. Signs and symptoms include: high
fever, stiff muscles, confusion, changes in breathing, heart rate,
and blood pressure, elevated creatinine phosphokinase,
myoglobinuria (and/or rhabdomyolysis), and acute renal failure.
Patients who experience signs and symptoms of NMS should
immediately contact their doctor or go to the emergency room.
- Tardive Dyskinesia, a syndrome of uncontrolled
body movements in the face, tongue, or other body parts, which may
increase with duration of treatment and total cumulative dose. TD
may not go away, even if CAPLYTA is discontinued. It can also occur
after CAPLYTA is discontinued.
- Metabolic Changes, including hyperglycemia,
diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in
some cases extreme and associated with ketoacidosis, hyperosmolar
coma or death, has been reported in patients treated with
antipsychotics. Measure weight and assess fasting plasma glucose
and lipids when initiating CAPLYTA and monitor periodically during
long-term treatment.
- Leukopenia, Neutropenia, and Agranulocytosis (including
fatal cases). Complete blood counts should be performed in
patients with pre-existing low white blood cell count (WBC) or
history of leukopenia or neutropenia. CAPLYTA should be
discontinued if clinically significant decline in WBC occurs in
absence of other causative factors.
- Decreased Blood Pressure & Dizziness.
Patients may feel lightheaded, dizzy or faint when they rise too
quickly from a sitting or lying position (orthostatic hypotension).
Heart rate and blood pressure should be monitored and patients
should be warned with known cardiovascular or cerebrovascular
disease. Orthostatic vital signs should be monitored in patients
who are vulnerable to hypotension.
- Falls. CAPLYTA may cause sleepiness or
dizziness and can slow thinking and motor skills, which may lead to
falls and, consequently, fractures and other injuries. Patients
should be assessed for risk when using CAPLYTA.
- Seizures. CAPLYTA should be used cautiously in
patients with a history of seizures or with conditions that lower
seizure threshold.
- Potential for Cognitive and Motor Impairment.
Patients should use caution when operating machinery or motor
vehicles until they know how CAPLYTA affects them.
- Body Temperature Dysregulation. CAPLYTA should
be used with caution in patients who may experience conditions that
may increase core body temperature such as strenuous exercise,
extreme heat, dehydration, or concomitant anticholinergics.
- Dysphagia. CAPLYTA should be used with caution
in patients at risk for aspiration.
Drug Interactions: CAPLYTA should not be used
with CYP3A4 inducers. Dose reduction is recommended for concomitant
use with strong CYP3A4 inhibitors or moderate CYP3A4
inhibitors.
Special Populations: Newborn infants exposed to
antipsychotic drugs during the third trimester of pregnancy are at
risk for extrapyramidal and/or withdrawal symptoms following
delivery. Dose reduction is recommended for patients with moderate
or severe hepatic impairment.
Adverse Reactions: The most common adverse
reactions in clinical trials with CAPLYTA vs. placebo were
somnolence/sedation, dizziness, nausea, and dry mouth.
CAPLYTA is available in 10.5 mg, 21 mg, and 42 mg capsules.
Please click here to see full Prescribing Information
including Boxed Warning.
About CAPLYTA (lumateperone)
CAPLYTA 42 mg is an oral, once daily atypical antipsychotic
approved in adults for the treatment of schizophrenia and the
treatment of depressive episodes associated with bipolar I or II
disorder (bipolar depression) as monotherapy and as adjunctive
therapy with lithium or valproate. While the mechanism of action of
CAPLYTA is unknown, the efficacy of CAPLYTA could be mediated
through a combination of antagonist activity at central serotonin
5-HT2A receptors and postsynaptic antagonist activity at central
dopamine D2 receptors.
Lumateperone is being studied for the treatment of major
depressive disorder, and other neuropsychiatric and neurological
disorders. Lumateperone is not FDA-approved for these
disorders.
About Intra-Cellular Therapies
Intra-Cellular Therapies is a biopharmaceutical company
founded on Nobel prize-winning research that allows us to
understand how therapies affect the inner-workings of cells in the
body. The company leverages this intracellular approach to develop
innovative treatments for people living with complex psychiatric
and neurologic diseases. For more information, please
visit www.intracellulartherapies.com.
Forward-Looking Statements
This news release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of 1995
that involve risks and uncertainties that could cause actual
results to be materially different from historical results or from
any future results expressed or implied by such forward-looking
statements. Such forward-looking statements include statements
regarding, among other things, our financial and operating
performance, including our future revenues and expenses; our
expectations regarding the commercialization of CAPLYTA; our plans
to conduct clinical or non-clinical trials and the timing of
developments with respect to those trials, including enrollment,
initiation or completion of clinical conduct, or the availability
of results; plans to make regulatory submissions to the FDA and the
timing of such submissions; whether clinical trial results will be
predictive of future real-world results; whether CAPLYTA will serve
an unmet need; the goals of our development programs; our beliefs
about the potential utility of our product candidates; and
development efforts and plans under the caption “About
Intra-Cellular Therapies.” All such forward-looking statements are
based on management's present expectations and are subject to
certain factors, risks and uncertainties that may cause actual
results, outcome of events, timing and performance to differ
materially from those expressed or implied by such statements.
These risks and uncertainties include, but are not limited to, the
following: there are no guarantees that CAPLYTA will be
commercially successful; we may encounter issues, delays or other
challenges in commercializing CAPLYTA; whether CAPLYTA receives
adequate reimbursement from third-party payors; the degree to which
CAPLYTA receives acceptance from patients and physicians for its
approved indications; challenges associated with execution of our
sales activities, which in each case could limit the potential of
our product; results achieved in CAPLYTA in the treatment of
schizophrenia and bipolar depression following commercial launch of
the product may be different than observed in clinical trials, and
may vary among patients; challenges associated with supply and
manufacturing activities, which in each case could limit our sales
and the availability of our product; risks associated with our
current and planned clinical trials; we may encounter unexpected
safety or tolerability issues with CAPLYTA following commercial
launch for the treatment of schizophrenia or bipolar depression or
in ongoing or future trials and other development activities; our
other product candidates may not be successful or may take longer
and be more costly than anticipated; product candidates that
appeared promising in earlier research and clinical trials may not
demonstrate safety and/or efficacy in larger-scale or later
clinical trials or in clinical trials for other indications; our
proposals with respect to the regulatory path for our product
candidates may not be acceptable to the FDA; our reliance on
collaborative partners and other third parties for development of
our product candidates; impacts on our business, including on the
commercialization of CAPLYTA and our clinical trials, as a result
of the COVID-19 pandemic, the conflicts in Ukraine and the Middle
East, global economic uncertainty, inflation, higher interest rates
or market disruptions; and the other risk factors detailed in our
public filings with the Securities and Exchange Commission. All
statements contained in this press release are made only as of the
date of this press release, and we do not intend to update this
information unless required by law.
Contact:
Intra-Cellular Therapies, Inc.Juan Sanchez, M.D. Vice President,
Corporate Communications and Investor Relations646-440-9333
Burns McClellan, Inc.Cameron
Radinoviccradinovic@burnsmc.com212-213-0006
INTRA-CELLULAR THERAPIES, INC. |
|
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (in thousands except share and per
share amounts) (Unaudited) (1) |
|
|
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenues |
|
|
|
|
|
|
|
Product sales, net |
$ |
131,506 |
|
|
$ |
87,433 |
|
|
$ |
462,175 |
|
|
$ |
249,132 |
|
Grant revenue |
|
593 |
|
|
|
436 |
|
|
|
2,195 |
|
|
|
1,182 |
|
Total revenues, net |
|
132,099 |
|
|
|
87,869 |
|
|
|
464,370 |
|
|
|
250,314 |
|
Operating expenses: |
|
|
|
|
|
|
|
Cost of product sales |
|
10,702 |
|
|
|
6,788 |
|
|
|
33,745 |
|
|
|
20,443 |
|
Selling, general and administrative |
|
104,720 |
|
|
|
94,631 |
|
|
|
409,864 |
|
|
|
358,782 |
|
Research and development |
|
50,774 |
|
|
|
33,862 |
|
|
|
180,142 |
|
|
|
134,715 |
|
Total operating expenses |
|
166,196 |
|
|
|
135,281 |
|
|
|
623,751 |
|
|
|
513,940 |
|
Loss from operations |
|
(34,097 |
) |
|
|
(47,412 |
) |
|
|
(159,381 |
) |
|
|
(263,626 |
) |
Interest income |
|
5,966 |
|
|
|
3,386 |
|
|
|
20,343 |
|
|
|
7,376 |
|
Loss before provision for
income taxes |
|
(28,131 |
) |
|
|
(44,026 |
) |
|
|
(139,038 |
) |
|
|
(256,250 |
) |
Income tax expense |
|
(448 |
) |
|
|
— |
|
|
|
(636 |
) |
|
|
(6 |
) |
Net loss |
$ |
(28,579 |
) |
|
$ |
(44,026 |
) |
|
$ |
(139,674 |
) |
|
$ |
(256,256 |
) |
Net loss per common
share: |
|
|
|
|
|
|
|
Basic & Diluted |
$ |
(0.30 |
) |
|
$ |
(0.45 |
) |
|
$ |
(1.46 |
) |
|
$ |
(2.72 |
) |
Weighted average number of
common shares: |
|
|
|
|
|
|
|
Basic & Diluted |
|
96,285,558 |
|
|
|
94,516,794 |
|
|
|
95,881,729 |
|
|
|
94,046,670 |
|
(1) The condensed consolidated statements of operations for the
three and twelve months ended December 31, 2023 and 2022 have
been derived from the financial statements but do not include all
of the information and footnotes required by accounting principles
generally accepted in the United States for complete financial
statements.
INTRA-CELLULAR THERAPIES, INC. |
|
CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands
except share and per share amounts) (Unaudited) |
|
December 31,2023 |
|
December 31,2022 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
147,767 |
|
|
$ |
148,615 |
|
Investment securities, available-for-sale |
|
350,174 |
|
|
|
443,290 |
|
Restricted cash |
|
1,750 |
|
|
|
1,750 |
|
Accounts receivable, net |
|
114,018 |
|
|
|
75,189 |
|
Inventory |
|
11,647 |
|
|
|
23,920 |
|
Prepaid expenses and other current assets |
|
42,443 |
|
|
|
45,193 |
|
Total current assets |
|
667,799 |
|
|
|
737,957 |
|
Property and equipment,
net |
|
1,654 |
|
|
|
1,913 |
|
Right of use assets, net |
|
12,928 |
|
|
|
14,824 |
|
Inventory, non-current |
|
38,621 |
|
|
|
— |
|
Other assets |
|
7,293 |
|
|
|
86 |
|
Total assets |
$ |
728,295 |
|
|
$ |
754,780 |
|
Liabilities and
stockholders’ equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
11,452 |
|
|
$ |
10,395 |
|
Accrued and other current liabilities |
|
27,944 |
|
|
|
19,657 |
|
Accrued customer programs |
|
53,173 |
|
|
|
25,621 |
|
Accrued employee benefits |
|
27,364 |
|
|
|
22,996 |
|
Operating lease liabilities |
|
3,612 |
|
|
|
4,567 |
|
Total current liabilities |
|
123,545 |
|
|
|
83,236 |
|
Operating lease liabilities,
non-current |
|
13,326 |
|
|
|
15,474 |
|
Total liabilities |
|
136,871 |
|
|
|
98,710 |
|
Stockholders’ equity: |
|
|
|
Common stock, $0.0001 par value: 175,000,000 shares authorized at
December 31, 2023 and December 31, 2022, respectively; 96,379,811
and 94,829,794 shares issued and outstanding at December 31, 2023
and December 31, 2022, respectively |
|
10 |
|
|
|
9 |
|
Additional paid-in capital |
|
2,208,470 |
|
|
|
2,137,737 |
|
Accumulated deficit |
|
(1,617,160 |
) |
|
|
(1,477,486 |
) |
Accumulated comprehensive income (loss) |
|
104 |
|
|
|
(4,190 |
) |
Total stockholders’
equity |
|
591,424 |
|
|
|
656,070 |
|
Total liabilities and
stockholders’ equity |
$ |
728,295 |
|
|
$ |
754,780 |
|
The condensed consolidated balance sheets at December 31,
2023 and December 31, 2022 have been derived from the
financial statements but do not include all of the information and
footnotes required by accounting principles generally accepted
in the United States for complete financial
statements.
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