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, 2020, and provided a corporate update.
“2020 was a transformational year for our company with the
launch of our first product, CAPLYTA. I am proud of the important
progress that our organization has achieved. We navigated
unprecedented and challenging COVID-19 circumstances and still
accomplished key commercial and clinical development milestones,”
said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular
Therapies. “We look forward to continuing our progress as we seek
to expand our CAPLYTA label to include patients with bipolar
depression. We are excited about our late-stage lumateperone
programs in depressive disorders and the advancement of a
long-acting injectable formulation into clinical trials as well as
further expanding our pipeline with ITI-1284.”
YE 2020 Financial Highlights:
- Total revenues were $22.8 million
for the full year 2020. Net product revenues of CAPLYTA were $22.5
million for the full year 2020. No net product revenues were
reported for the comparable periods of 2019.
- Net loss for the year ended
December 31, 2020 was $227.0 million or $3.23 per share (basic and
diluted) compared to a net loss of $147.7 million or $2.68 per
share (basic and diluted) for the year ended December 31,
2019.
- Cost of product sales was
approximately $1.9 million for the year ended December 31, 2020.
Cost of product sales consisted primarily of product royalty fees,
overhead and minimal direct costs.
- Research and development (R&D)
expenses for the year ended December 31, 2020 were $65.8
million, compared to $89.1 million for the year ended
December 31, 2019, representing a decrease of approximately
$23.3 million, or 26%.
- Selling, general and administrative (SG&A) expenses were
$186.4 million for the year ended December 31, 2020, compared to
$64.9 million for the year ended December 31, 2019.
- Selling costs were
$132.5 million for the year ended December 31, 2020 as
compared to pre-commercialization costs of $32.5 million in
the same period in 2019. General and administrative expenses for
the year ended December 31, 2020 were $53.9 million, compared
to $32.4 million for the same period in 2019.
- Cash, cash equivalents, restricted
cash and investment securities totaled $658.8 million at December
31, 2020, compared to $224.0 million at December 31, 2019.
Fourth Quarter Financial Highlights:
- Net product revenues of CAPLYTA
were $12.4 million for the fourth quarter of 2020, compared to $7.4
million in net product revenues in the third quarter of 2020.
- Net loss for the quarter ended
December 31, 2020 was $60.7 million compared to a net loss of $40.6
million for the quarter ended December 31, 2019.
- Research and development (R&D)
expenses for the fourth quarter of 2020 were $14.3 million,
compared to $19.1 million for the fourth quarter of 2019.
This decrease is due primarily to a decrease in manufacturing
expense, and a decrease of lumateperone clinical and non-clinical
expenses.
- Selling, general and administrative
(SG&A) expenses were $58.3 million for the fourth quarter of
2020, compared to $22.8 million for the same period in 2019. This
increase is primarily due to an increase in sales related labor
costs and commercialization costs.
COMMERCIAL HIGHLIGHTS
- CAPLYTA was launched in late March
2020. Our commercial organization has successfully adapted to the
COVID-19 market environment and continues to effectively engage
with our prescribing audience through a hybrid model of virtual
engagements and in-person interactions, enhanced by an expanded
digital marketing initiative.
- Fourth quarter CAPLYTA results
reflect strong commercial execution delivering continued robust
prescription growth, increasing total prescriptions 77% versus the
third quarter.
- Established strong CAPLYTA market
access coverage with greater than 95% of covered lives in both
Medicare Part D and State Medicaid, the major payer channels in
schizophrenia. Our LytaLink program continues to be highly
competitive and effective in supporting prescribing physicians and
eligible patients’ access to CAPLYTA.
2020/2021 CLINICAL HIGHLIGHTS
Lumateperone - Bipolar Depression Program:
- We submitted our sNDAs to the FDA
for lumateperone as monotherapy and as adjunctive treatment with
lithium or valproate for the treatment of depressive episodes
associated with bipolar I or II disorder (bipolar depression) in
adults. We anticipate an FDA target action date in the second half
of 2021.
- We reported positive topline results
from Study ‘402, a global Phase 3 clinical trial evaluating
lumateperone as adjunctive therapy to lithium or valproate in the
treatment of major depressive episodes associated with Bipolar I or
Bipolar II disorder. Lumateperone 42 mg met the primary endpoint
for improvement in depression as measured by change from baseline
versus placebo on the Montgomery–Åsberg Depression Rating Scale
(MADRS) total score. Lumateperone was generally well-tolerated in
the trial.
Other Lumateperone Programs
- Mixed Features program: Study ‘403
is a large global clinical trial evaluating lumateperone 42 mg in
two patient populations: patients with MDD and patients with
bipolar depression who exhibit mixed features. The primary endpoint
is change from baseline on the MADRS total score at week 6 versus
placebo. Results from this study are anticipated in the second half
of 2022.
- Adjunctive MDD program: Commenced a
Phase 3 clinical program evaluating lumateperone 42 mg as an
adjunctive therapy to antidepressants for the treatment of MDD.
Clinical conduct in two studies, Studies ‘501 and ‘502, is
anticipated to begin in 2021.
- Lumateperone Long Acting Injectable
(LLAI) formulation: Commenced Study ITI-007-025, a Phase 1 single
ascending dose study of LLAI, a formulation designed to be
administered subcutaneously and to maintain therapeutic levels of
lumateperone for at least one month. Initial results from this
study are anticipated in the second half of 2021.
CAPLYTA- Schizophrenia
- Recently announced the online
publication of “Safety and tolerability of lumateperone 42 mg: An
open-label antipsychotic switch study in outpatients with stable
schizophrenia" (Correll et al. 2021) in the
journal, Schizophrenia Research.
Other Programs
- ITI-1284 program: We recently
announced our pipeline expansion with ITI-1284 ODT-SL. ITI-1284 is
a deuterated form of lumateperone, a new molecular entity
formulated as an orally disintegrating tablet for sublingual
administration that has recently completed Phase 1 studies. In
these studies, ITI-1284 was generally safe and well-tolerated. We
plan to initiate studies evaluating ITI-1284 for the treatment of
behavioral disturbances in patients with dementia, the treatment of
dementia-related psychosis and the treatment of certain depressive
disorders in the elderly.
- Phosphodiesterase type I inhibitor (PDE1) program: Our PDE1
inhibitor program is focused on diseases in which the PDE1 enzyme
is over-expressed and/or abnormal immune cell function contributes
to disease pathology providing opportunities to pursue innovative
treatments for multiple diseases including Parkinson’s, heart
failure and other diseases. We have previously reported positive
results from Phase 1/2a studies evaluating lenrispodun (ITI-214),
our lead molecule, in patients with Parkinson’s disease and in
patients with chronic systolic heart failure. We plan to advance
lenrispodun into a Phase 2 clinical study in Parkinson’s disease in
2021.
- ITI-333 program in opioid use
disorder: Commenced Study ITI-333-001, a Phase 1 single ascending
dose study evaluating the safety, tolerability and pharmacokinetics
of ITI-333 in healthy volunteers. Results from this study are
anticipated in the second half of 2021.
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 8499868. Please
dial in approximately 10 minutes prior to the call.
CAPLYTA® (lumateperone) is indicated for the treatment of
schizophrenia in adults. CAPLYTA is available in 42 mg
capsules.
Important Safety Information
Boxed Warning: 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.
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.
- Sleepiness and Trouble Concentrating. 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, moderate or strong CYP3A4 inhibitors and UGT
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. Breastfeeding is not recommended. Use of CAPLYTA should
be avoided in patients with moderate or severe liver problems.
Adverse Reactions: The most common adverse
reactions in clinical trials with CAPLYTA vs. placebo were
somnolence/sedation (24% vs. 10%) and dry mouth (6% vs. 2%).Please
click here to see full Prescribing Information
including Boxed Warning.
About CAPLYTA (lumateperone)
CAPLYTA 42mg/day is an oral, once daily atypical antipsychotic
approved for the treatment of schizophrenia of adults. While the
mechanism of action of CAPLYTA in the treatment of schizophrenia 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.
CAPLYTA (lumateperone) is being investigated for the treatment
of bipolar depression, depression and other neuropsychiatric and
neurological disorders. CAPLYTA 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; the anticipated timing of the FDA
target action date for our bipolar depression sNDAs, if accepted by
the FDA, and the adequacy of the data contained in the sNDAs to
serve as the basis for approval of lumateperone for the treatment
of depressive episodes associated with bipolar I or II disorder
both as monotherapy and as adjunctive therapy in adults; our plans
and expected timing to initiate our lumateperone clinical studies
in major depressive disorder; our plans and expected timing for
results from our lumateperone long-acting injectable clinical
trial; our plans and expected timing for results from our from our
ITI-333 clinical trial; our development plans for our PDE program,
including ITI-214; our development plans for our ITI-1284 program;
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: whether the sNDAs for lumateperone will be accepted for
review by the FDA; if accepted, whether the preclinical and
clinical results of the lumateperone studies will meet the
regulatory requirements for approval by the FDA for the
proposed indications; whether the sNDAs will be approved by
the FDA and whether the FDA will complete its review within
its target timelines, including its target action date once
established; whether the FDA will require additional information,
whether we will be able to provide in a timely manner any
additional information that the FDA requests, and whether such
additional information will be satisfactory to the FDA; 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 indication; 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 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; 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 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
Burnsjgrimaldi@burnsmc.com 212-213-0006
MEDIA INQUIRIES:
Ana FullmerCorporate Media Relations
W2Owcgafullmer@wcgworld.com 202-507-0130
INTRA-CELLULAR THERAPIES,
INC.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
|
|
|
|
|
|
|
Three Months Ended December 31, |
Year Ended December 31, |
|
|
2020 |
|
|
2019 |
|
|
2020(1) |
|
|
2019(1) |
|
|
|
|
|
|
|
(Unaudited) |
(Unaudited) |
(Unaudited) |
(Unaudited) |
Revenues |
|
|
|
|
Product sales, net |
$ |
12,403,754 |
|
$ |
— |
|
$ |
22,530,753 |
|
$ |
— |
|
Grant revenue |
|
50,516 |
|
|
60,613 |
|
|
282,226 |
|
|
60,613 |
|
Revenues, net |
|
12,454,270 |
|
|
60,613 |
|
|
22,812,979 |
|
|
60,613 |
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
Cost of product sales |
|
1,141,072 |
|
|
— |
|
|
1,895,029 |
|
|
— |
|
Research and development |
|
14,298,586 |
|
|
19,065,725 |
|
|
65,782,137 |
|
|
89,124,838 |
|
Selling, general and administrative |
|
58,347,948 |
|
|
22,763,547 |
|
|
186,363,444 |
|
|
64,947,625 |
|
Total costs and expenses |
|
73,787,606 |
|
|
41,829,272 |
|
|
254,040,610 |
|
|
154,072,463 |
|
|
|
|
|
|
Loss from operations |
|
(61,333,336 |
) |
|
(41,768,659 |
) |
|
(231,227,631 |
) |
|
(154,011,850 |
) |
Interest income |
|
(644,390 |
) |
|
(1,185,808 |
) |
|
(4,235,481 |
) |
|
(6,291,272 |
) |
Income tax expense |
|
10,232 |
|
|
— |
|
|
13,513 |
|
|
1,600 |
|
Net loss |
$ |
(60,699,178 |
) |
$ |
(40,582,851 |
) |
$ |
(227,005,663 |
) |
$ |
(147,722,178 |
) |
|
|
|
|
|
Net loss per common share: |
|
|
|
|
Basic & Diluted |
$ |
(0.76 |
) |
$ |
(0.74 |
) |
$ |
(3.23 |
) |
$ |
(2.68 |
) |
|
|
|
|
|
Weighted average number of common
shares: |
|
|
|
|
Basic & Diluted |
|
80,293,750 |
|
|
55,276,251 |
|
|
70,364,800 |
|
|
55,186,206 |
|
(1) The condensed consolidated statements of
operations for the years ended December 31, 2020 and 2019 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
|
|
|
|
|
|
|
|
|
|
|
December 31,2020 (1) |
|
|
|
December 31,2019 (1) |
|
|
|
|
Assets |
|
|
Current assets: |
|
|
Cash and cash
equivalents |
$ |
60,045,933 |
|
|
$ |
107,636,849 |
|
Investment securities,
available-for-sale |
|
597,402,126 |
|
|
|
116,373,335 |
|
Restricted
cash |
|
1,400,000 |
|
|
|
— |
|
Accounts receivable, less allowance of $120,000 and $0 at December
31, 2020 and 2019,
respectively |
|
10,764,583 |
|
|
|
— |
|
Inventory |
|
7,056,385 |
|
|
|
— |
|
Prepaid expenses and other current
assets |
|
14,235,455 |
|
|
|
6,313,785 |
|
Total current
assets |
|
690,904,482 |
|
|
|
230,323,969 |
|
Property and equipment,
net |
|
1,998,346 |
|
|
|
2,259,740 |
|
Right of use assets,
net |
|
24,324,762 |
|
|
|
18,252,074 |
|
Deferred tax asset,
net |
|
— |
|
|
|
264,609 |
|
Other assets |
|
86,084 |
|
|
|
86,084 |
|
Total assets |
$ |
717,313,674 |
|
|
$ |
251,186,476 |
|
Liabilities and stockholders’ equity |
|
|
Current liabilities: |
|
|
Accounts
payable |
$ |
5,501,825 |
|
|
$ |
7,425,024 |
|
Accrued and other current
liabilities |
|
10,902,117 |
|
|
|
16,138,909 |
|
Lease liabilities,
short-term |
|
5,541,802 |
|
|
|
3,187,435 |
|
Accrued employee
benefits |
|
14,907,479 |
|
|
|
9,472,651 |
|
Total current
liabilities |
|
36,853,223 |
|
|
|
36,224,019 |
|
Lease
liabilities |
|
23,600,347 |
|
|
|
19,955,186 |
|
Total
liabilities |
|
60,453,570 |
|
|
|
56,179,205 |
|
Stockholders’ equity: |
|
|
Common stock, $0.0001 par value: 100,000,000 shares authorized;
80,463,089 and 55,507,497 shares issued and outstanding at
December 31, 2020 and 2019,
respectively |
|
8,046 |
|
|
|
5,551 |
|
Additional paid-in
capital |
|
1,593,475,506 |
|
|
|
904,971,772 |
|
Accumulated
deficit |
|
(937,104,032 |
) |
|
|
(710,098,369 |
) |
Accumulated comprehensive
income |
|
480,584 |
|
|
|
128,317 |
|
Total stockholders’
equity |
|
656,860,104 |
|
|
|
195,007,271 |
|
Total liabilities and stockholders’
equity |
$ |
717,313,674 |
|
|
$ |
251,186,476 |
|
|
|
|
|
|
|
|
|
|
(1) The condensed consolidated balance sheets
at December 31, 2020 and 2019 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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