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 first quarter ended March
31, 2022 and provided a corporate update.
“We are encouraged by the robust uptake of CAPLYTA in the first
full quarter following our late December 2021 launch in bipolar
depression and are confident in our ability to deliver continued
strong growth and to improve the lives of patients. We continue to
advance our pipeline, including our lumateperone programs in major
depressive disorder (MDD) and mixed features,” said Dr. Sharon
Mates, Chairman and CEO of Intra-Cellular Therapies.
First Quarter Financial Highlights:
- Total revenues were $35.0 million
for the first quarter of 2022, compared to $15.9 million of total
revenues for the first quarter of 2021. Net product revenues of
CAPLYTA were $34.8 million for the first quarter of 2022, compared
to $15.6 million in net product revenues of CAPLYTA for the same
period in 2021, representing a year-over-year increase of 123% and
a 36% increase over the fourth quarter of 2021.
- Cost of product sales were $3.2
million in the first quarter of 2022, compared to $1.5 million for
the first quarter of 2021.
- Research and development (R&D)
expenses for the first quarter of 2022 were $29.0 million,
compared to $15.1 million for the first quarter of 2021.
This increase is due to higher lumateperone clinical trial and
non-clinical related costs and an increase in non-lumateperone
project costs.
- Selling, general and administrative
(SG&A) expenses were $75.5 million for the first quarter of
2022, compared to $52.6 million for the first quarter of 2021. This
increase is primarily due to an increase in commercialization,
marketing and labor related costs.
- Net loss for the quarter ended
March 31, 2022 was $72.1 million, compared to a net loss of $52.7
million for the quarter ended March 31, 2021.
- Cash, cash equivalents, restricted
cash and investment securities totaled $773.2 million at March 31,
2022, compared to $413.7 million at December 31, 2021. On January
7, 2022, we completed a public offering of our common stock in
which we sold approximately 10.95 million shares of common stock
for aggregate gross proceeds of $460.0 million and net proceeds,
after deducting underwriting discounts and commissions and offering
expenses, of approximately $433.7 million.
COMMERCIAL HIGHLIGHTS
- CAPLYTA launched in bipolar
depression immediately following its U.S. Food and Drug
Administration (FDA) approval in late December 2021. CAPLYTA is the
first and only FDA-approved treatment for depressive episodes
associated with bipolar I or II disorder (bipolar depression) in
adults as monotherapy and as adjunctive therapy with lithium or
valproate.
- Significant inflection in both new
and total prescriptions reflecting robust growth following approval
in bipolar depression. First quarter CAPLYTA new and total
prescriptions increased by 63% and 45%, respectively, versus the
fourth quarter of 2021. First quarter CAPLYTA new and total
prescriptions increased by 154% and 134%, respectively, versus the
first quarter of 2021.
- New-to-brand prescriptions,
representing new CAPLYTA patient starts, have increased by
approximately 300% following bipolar depression approval.
New-to-brand prescriptions are considered a key leading indicator
of growth during the launch phase, reflecting early adoption by
prescribers. These encouraging uptake trends have been accompanied
by positive physician receptivity to CAPLYTA.
- CAPLYTA maintained broad
coverage in the Medicare Part D and
Medicaid channels, with greater than 98% of lives covered and
expanded coverage in the commercial channel to over 80% of lives
covered. Our LytaLink patient support program continues to be
very effective in supporting patient access.
CLINICAL HIGHLIGHTS
Lumateperone:
- Received approval by the FDA
for two new dosage strengths of CAPLYTA, 10.5 mg and 21 mg
capsules, to provide dosage recommendations for patients
concomitantly taking strong or moderate CYP3A4 inhibitors, and 21
mg for patients with moderate or severe hepatic impairment
(Child-Pugh class B or C). This strengthens CAPLYTA’s overall
profile even further by expanding the appropriate patient base
within the highly prevalent conditions of bipolar disorder and
schizophrenia.
- Adjunctive MDD program: Patient
enrollment in pivotal studies 501 and 502 is ongoing. These are
Phase 3 double blind, placebo-controlled, 6-week global studies
evaluating lumateperone 42 mg as adjunctive treatment to
anti-depressants. The primary endpoint is change from baseline
versus placebo on the MADRS total score at week 6, and the CGI-S
scale is the key secondary endpoint. We expect to file a
supplemental New Drug Application (sNDA) with the FDA for
lumateperone as an adjunctive therapy to antidepressants for the
treatment of MDD in 2024.
- Mixed Features program: Clinical
conduct is ongoing in Study 403, a global clinical trial evaluating
lumateperone 42 mg in patients with MDD and in patients with
bipolar depression who exhibit mixed features. We expect to
complete clinical conduct in this Study in the second half of
2022.
- Lumateperone Long Acting Injectable
(LLAI) formulation: Initial clinical conduct in our Phase 1 single
ascending study has been completed, and we are encouraged by the
safety and tolerability results we have seen to date. We are
exploring alternate sites of injection with the current formulation
as well as progressing the development of other formulations. The
goal of our program is to develop LLAI formulations that are
effective, safe and well-tolerated with treatment durations of one
month and longer. Together, these Phase 1 studies will assist us in
designing formulation and dosing strategies for our efficacy
studies.
Other Programs:
- ITI-1284-ODT-SL program: ITI-1284
ODT-SL Phase 1 studies are either ongoing or planned, including
food effect and brain-imaging studies. We expect to commence
clinical conduct in our agitation in patients with probable
Alzheimer’s disease program in 2022, followed by additional studies
in dementia-related psychosis and certain depressive disorders in
the elderly. We have previously completed single and multiple
ascending dose studies in healthy young and elderly subjects,
demonstrating rapid absorption and excellent drug exposure,
allowing doses to be selected for our next studies.
- Phosphodiesterase type I inhibitor
(PDE1) program: Lenrispodun (ITI-214) is our lead compound in
this program. We expect to initiate patient enrollment/clinical
conduct in our lenrispodun Phase 2 clinical trial for the
treatment of Parkinson’s disease in the first half of 2022.In
preclinical studies, we have shown that PDE1 inhibitors can inhibit
the recruitment of immune cells such as microglia and macrophages
into tumors, thereby altering the tumor microenvironment. We have
shown that lenrispodun can potentiate the action of PD-1 inhibitors
in various models of colorectal, kidney, breast and glioblastoma
cancers. Recently, at the American Association for Cancer
Research (AACR) Annual Meeting, we presented preclinical data
describing the antitumor effects of PDE1 inhibitors when
administered in conjunction with checkpoint inhibitor immunotherapy
in an animal model of breast cancer. Additional data from this
program will be presented at upcoming conferences this year.
- ITI-333 program in Opioid Use
Disorder: Following the positive results from our Phase 1 single
ascending dose study evaluating the safety, tolerability and
pharmacokinetics of ITI-333 in healthy volunteers, our plan is to
advance the development of ITI-333 with neuroimaging studies,
followed by a multiple ascending dose study.
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. The live webcast
and subsequent replay may be accessed by visiting the Company's
website at www.intracellulartherapies.com. Please connect to
the Company's website at least 5-10 minutes prior to the live
webcast to ensure adequate time for any necessary software
download. Alternatively, please call 1-(844) 835-6563 (U.S.) or
1-(970) 315-3916 (international) to listen to the live conference
call. The conference ID number for the live call is 9526447. Please
dial in approximately 10 minutes prior to the call.
CAPLYTA® (lumateperone) is indicated in adults for the treatment
of schizophrenia and depressive episodes associated with bipolar I
or II disorder (bipolar depression) as monotherapy and as
adjunctive therapy with lithium or valproate. CAPLYTA is available
in 42 mg capsules.
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 anti-depressant-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 (10.5 mg) or moderate CYP3A4
inhibitors (21 mg).
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. Breastfeeding is not recommended. Dose reduction is
recommended for patients with moderate or severe hepatic impairment
(21 mg).
Adverse Reactions: The most common adverse
reactions in clinical trials with CAPLYTA vs. placebo were
somnolence/sedation, dizziness, nausea, and dry mouth.
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
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 expectations regarding the
commercialization of CAPLYTA; our plans to conduct clinical or
nonclinical trials and the timing of 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; 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; the COVID-19
pandemic may negatively impact our commercial plans and sales for
CAPLYTA; the COVID-19 pandemic may negatively impact the conduct
of, and the timing of enrollment, completion and reporting with
respect to, our clinical trials; 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; any other impacts on our business as a
result of or related to the COVID-19 pandemic; challenges
associated with supply and manufacturing activities, which in each
case could limit our sales and the availability of our product;
impacts on our business, including on the commercialization of
CAPLYTA and our clinical trials, as a result of the conflict in
Ukraine; 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; 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.Lisa
Burnscradinovic@burnsmc.com212-213-0006
INTRA-CELLULAR THERAPIES,
INC.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (in thousands except share and per
share amounts) (Unaudited)
|
Three Months Ended March 31, |
|
|
2022 |
|
|
|
2021 |
|
Revenues |
|
|
Product sales, net |
$ |
34,755 |
|
|
$ |
15,579 |
|
Grant revenue |
|
241 |
|
|
|
299 |
|
Total revenues |
|
34,996 |
|
|
|
15,878 |
|
|
|
|
Operating expenses: |
|
|
Cost of product sales |
|
3,155 |
|
|
|
1,455 |
|
Research and development |
|
29,043 |
|
|
|
15,058 |
|
Selling, general and administrative |
|
75,460 |
|
|
|
52,584 |
|
Total operating expenses |
|
107,658 |
|
|
|
69,097 |
|
Loss from operations |
|
(72,662) |
|
|
|
(53,219) |
|
Interest income |
|
548 |
|
|
|
484 |
|
Loss before provision for
income taxes |
|
(72,114) |
|
|
|
(52,735) |
|
Income tax expense |
|
5 |
|
|
|
5 |
|
Net loss |
$ |
(72,119) |
|
|
$ |
(52,740) |
|
Net loss per common share: |
|
|
Basic & Diluted |
$ |
(0.78) |
|
|
$ |
(0.65) |
|
Weighted average number of common
shares: |
|
|
Basic & Diluted |
|
92,604,290 |
|
|
|
80,946,450 |
|
The condensed consolidated statements of operations for the
quarters ended March 31, 2022 and 2021 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)
|
|
|
|
|
|
|
|
March 31,2022 |
|
|
December 31,2021 |
|
|
(Unaudited) |
|
|
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
129,295 |
|
|
$ |
92,365 |
|
Investment securities, available-for-sale |
|
642,553 |
|
|
|
319,969 |
|
Restricted cash |
|
1,400 |
|
|
|
1,400 |
|
Accounts receivable, net |
|
32,832 |
|
|
|
20,156 |
|
Inventory |
|
7,893 |
|
|
|
7,948 |
|
Prepaid expenses and other current assets |
|
34,369 |
|
|
|
25,443 |
|
Total current assets |
|
848,342 |
|
|
|
467,281 |
|
Property and equipment, net |
|
2,185 |
|
|
|
1,791 |
|
Right of use assets, net |
|
17,967 |
|
|
|
20,764 |
|
Other assets |
|
86 |
|
|
|
86 |
|
Total assets |
$ |
868,580 |
|
|
$ |
489,922 |
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
Current liabilities: |
|
|
Accounts payable |
$ |
11,649 |
|
|
$ |
8,691 |
|
Accrued and other current liabilities |
|
12,258 |
|
|
|
11,073 |
|
Accrued customer programs |
|
10,888 |
|
|
|
5,964 |
|
Lease liabilities, short-term |
|
7,636 |
|
|
|
6,732 |
|
Accrued employee benefits |
|
16,643 |
|
|
|
20,897 |
|
Total current liabilities |
|
59,074 |
|
|
|
53,357 |
|
Lease liabilities |
|
16,756 |
|
|
|
18,675 |
|
Total liabilities |
|
75,830 |
|
|
|
72,032 |
|
Stockholders’ equity: |
|
|
Common stock, $0.0001 par value: 175,000,000 shares authorized at
March 31, 2022 and December 31, 2021; 94,020,425 and 81,896,965
shares issued and outstanding at March 31, 2022 and
December 31, 2021, respectively |
|
9 |
|
|
|
8 |
|
Additional paid-in capital |
|
2,089,418 |
|
|
|
1,639,476 |
|
Accumulated deficit |
|
(1,293,349) |
|
|
|
(1,221,230) |
|
Accumulated comprehensive loss |
|
(3,328) |
|
|
|
(364) |
|
Total stockholders’ equity |
|
792,750 |
|
|
|
417,890 |
|
Total liabilities and
stockholders’ equity |
$ |
868,580 |
|
|
$ |
489,922 |
|
|
|
|
The condensed consolidated balance sheets at March 31, 2022 and
December 31, 2021 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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