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 second quarter ended June
30, 2020, and provided a corporate update.
“We have completed our first full quarter of commercial
activities, adapting to the unprecedented challenges of the
COVID-19 pandemic, and I am encouraged by CAPLYTA’s week over week
prescription growth and increasing prescriber base,” said
Dr. Sharon Mates, Chairman and CEO of Intra-Cellular
Therapies. “I am pleased with our team’s performance in the
current environment, the positive physician response to CAPLYTA and
the impact we are making in the lives of patients suffering from
schizophrenia. We are also excited about advancements in our
pipeline, including the upcoming announcement of results from our
Phase 3 clinical trial evaluating lumateperone as an adjunctive
treatment in bipolar depression (Study 402) and the continued
progress in our other pipeline programs.”
CORPORATE UPDATE
COMMERCIAL HIGHLIGHTS
- CAPLYTA promotional activities for the treatment of
schizophrenia in adults commenced the week of March 30, 2020. Our
commercial organization quickly adapted to the challenges to the
healthcare industry and patient care brought by COVID-19.
- Following a successful virtual launch, our neuroscience sales
specialists are actively engaging with healthcare providers
educating on CAPLYTA. We have been effectively engaging with our
prescribing audience through a mix of personal and non-personal
promotion including both remote, and more recently, live in-person
interactions with our sales team, peer to peer medical education,
journal advertising, virtual conferences & product theatre
presentations and digital marketing efforts.
- CAPLYTA has now achieved formulary coverage for greater than
95% of covered lives in both Medicare Part D and State Medicaid,
our two largest channels. We continue to see coverage determination
improvements in the commercial payer channel with final coverage
expected to be established by the end of this year.
- We are launching our new consumer campaign called “Real
Progress”. The purpose of the campaign is to educate patients and
caregivers about CAPLYTA and to open the dialogue about optimizing
care and treatment options. “Real Progress” includes a national
direct-to-consumer (or DTC) television advertising campaign and
accompanying social media campaign, as well as a partnership with a
leading telepsychiatry platform.
- Our LYTAlink™ patient access and affordability program is fully
operational and performing as planned. The program offerings
consist of coverage and reimbursement services, out-of-pocket copay
support for commercially insured patients, medication compliance
communications, and patient assistance relief specifically for
eligible patients without insurance.
CLINICAL HIGHLIGHTS
- Lumateperone in Bipolar Depression: Study 402, our Phase 3
study evaluating lumateperone as adjunctive therapy in bipolar
depression, has completed clinical conduct and we anticipate
reporting topline results from this study by mid-September
2020. This global study enrolled patients with major
depressive episodes associated with either Bipolar I or Bipolar II
disorder, who were randomized (1:1:1) to receive lumateperone 42
mg, 28 mg or placebo once daily for six weeks, while being
maintained on lithium or valproate as mood stabilizers. The primary
endpoint is change from baseline on the Montgomery–Åsberg
Depression Rating Scale (MADRS) total score at week 6.Study 403, a
Phase 3 global study evaluating lumateperone 42 mg as monotherapy
in the treatment of depression in patients with Bipolar I or
Bipolar II disorder, is ongoing. We anticipate reporting top-line
results from this study in the second half of 2021.
- ITI-214 in Heart Failure: We reported positive results from our
Phase 1/2 clinical trial of ITI-214, our phosphodiesterase 1 (PDE1)
inhibitor, in patients with chronic systolic heart failure.
This study evaluated the hemodynamic profile and safety of single
ascending doses of ITI-214. In the study, ITI-214 improved cardiac
output both by increasing heart contractility and by decreasing
vascular resistance, that is, ITI-214 functions as an inodilator.
The improvement in cardiac output was not associated with the
development of arrhythmias in patients. Details of these results
will be presented at upcoming medical conferences.
- Other Clinical Programs: We plan to initiate our lumateperone
clinical program in major depressive disorder later this year. In
addition, we expect to initiate human testing of our lumateperone
long-acting injectable program later this year. We also expect to
initiate early stage clinical studies for ITI-333, our novel, oral
modulator of mu opioid and serotonin receptors for the treatment of
opioid and other substance use disorders, pain, and mood
disorders.
Selected Second Quarter 2020 Financial Results
The Company recorded net product sales of CAPLYTA for the second
quarter of 2020 of approximately $1.9 million. No net product sales
were reported for the comparable period of 2019.
The Company reported a net loss of $63.7 million, or $0.96 per
share (basic and diluted), for the second quarter of 2020 compared
to a net loss of $37.4 million, or $0.68 per share (basic and
diluted), for the second quarter of 2019.
Research and development (R&D) expenses for the second
quarter of 2020 were $25.2 million, compared to $23.7 million for
the second quarter of 2019. The $1.5 million increase is
primarily due to an increase of approximately $9.2 million of
lumateperone clinical costs and an increase of approximately $0.6
million in stock compensation expense and overhead expenses and is
offset by a decrease of approximately $5.3 million of manufacturing
costs, and a decrease of approximately $3.0 million for
non-clinical related efforts.
Selling, general and administrative (SG&A) expenses were
$41.4 million for the second quarter of 2020, compared to $15.4
million for the same period in 2019. The increase of $26.0 million
is due to an increase of $20.6 million for selling related costs
and an increase of $5.4 million for general and administrative
costs. The increase in selling related costs is due primarily to
hiring a sales force, resulting in an increase in labor expenses of
$15.0 million and commercialization and marketing costs of $5.0
million. The increase in general and administrative costs is due
primarily to an increase in labor related expenses of $2.3 million,
information technology expenses of $1.5 million, and professional
fees of $1.0 million.
Cash, cash equivalents, restricted cash and investment
securities totaled $409.2 million at June 30, 2020, compared to
$224.0 million at December 31, 2019. In January 2020, the Company
completed a $295.0 million public offering resulting in net
proceeds to the Company of approximately $277.0 million from the
sale of 10 million shares of its common stock, after deducting
underwriting discounts and commissions and offering expenses paid
by the Company.
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 1574586. 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; our expectations about coverage of
CAPLYTA by payors; our plans and the expected timing for the
availability and reporting of data from our ongoing Phase 3 trials
in bipolar depression; our plans and expected timing to initiate
our lumateperone clinical program in major depressive disorder; our
plans and expected timing to initiate human testing of our
lumateperone long-acting injectable program; our plans and expected
timing to initiate early stage clinical studies for ITI-333; our
development plans for our PDE program, including ITI-214; 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
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 Relations 646-440-9333
Burns McClellan, Inc. Lisa Burns jgrimaldi@burnsmc.com
212-213-0006
MEDIA INQUIRIES:
Ana Fullmer Corporate Media Relations W2Owcg
afullmer@wcgworld.com 202-507-0130
INTRA-CELLULAR THERAPIES,
INC.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (Unaudited)
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales, net |
$ |
1,875,889 |
|
|
$ |
— |
|
|
$ |
2,758,405 |
|
|
$ |
— |
|
Grant revenue |
|
30,747 |
|
|
|
— |
|
|
|
231,710 |
|
|
|
— |
|
Total revenues |
|
1,906,636 |
|
|
|
— |
|
|
|
2,990,115 |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
Cost of product sales |
|
128,539 |
|
|
|
— |
|
|
|
197,850 |
|
|
|
— |
|
Research and development |
|
25,204,857 |
|
|
|
23,728,464 |
|
|
|
41,208,183 |
|
|
|
48,719,321 |
|
Selling, general and administrative |
|
41,445,557 |
|
|
|
15,442,650 |
|
|
|
75,541,923 |
|
|
|
27,147,634 |
|
Total operating expenses |
|
66,778,953 |
|
|
|
39,171,114 |
|
|
|
116,947,956 |
|
|
|
75,866,955 |
|
Loss from operations |
|
(64,872,317 |
) |
|
|
(39,171,114 |
) |
|
|
(113,957,841 |
) |
|
|
(75,866,955 |
) |
Interest income |
|
1,160,059 |
|
|
|
1,731,550 |
|
|
|
2,838,262 |
|
|
|
3,591,627 |
|
Loss before provision for income taxes |
|
(63,712,258 |
) |
|
|
(37,439,564 |
) |
|
|
(111,119,579 |
) |
|
|
(72,275,328 |
) |
Income tax expense |
|
— |
|
|
|
1,600 |
|
|
|
3,281 |
|
|
|
1,600 |
|
Net loss |
$ |
(63,712,258 |
) |
|
$ |
(37,441,164 |
) |
|
$ |
(111,122,860 |
) |
|
$ |
(72,276,928 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share: |
|
|
|
|
|
|
|
Basic & Diluted |
$ |
(0.96 |
) |
|
$ |
(0.68 |
) |
|
$ |
(1.69 |
) |
|
$ |
(1.31 |
) |
Weighted average number of common shares: |
|
|
|
|
|
|
|
Basic & Diluted |
|
66,429,371 |
|
|
|
55,145,901 |
|
|
|
65,767,737 |
|
|
|
55,129,654 |
|
(1) The condensed consolidated statements of operations for the
quarters ended June 30, 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
|
|
|
|
|
|
June 30, 2020 |
|
December 31, 2019 |
|
|
|
|
|
|
|
(Unaudited) |
|
|
Assets |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$ |
129,290,445 |
|
$ |
107,636,849 |
|
Investment securities, available-for-sale |
|
278,468,502 |
|
|
116,373,335 |
|
Restricted cash |
|
1,400,000 |
|
|
— |
|
Accounts receivable, net |
|
2,353,255 |
|
|
— |
|
Inventory |
|
2,335,042 |
|
|
— |
|
Prepaid expenses and other current assets |
|
4,726,134 |
|
|
6,313,785 |
|
Total current assets |
|
418,573,378 |
|
|
230,323,969 |
|
Property and equipment, net |
|
2,000,687 |
|
|
2,259,740 |
|
Right of use assets, net |
|
20,270,675 |
|
|
18,252,074 |
|
Deferred tax asset, net |
|
— |
|
|
264,609 |
|
Other assets |
|
86,084 |
|
|
86,084 |
|
Total assets |
$ |
440,930,824 |
|
$ |
251,186,476 |
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
Current liabilities: |
|
|
Accounts payable |
$ |
5,472,987 |
|
$ |
7,425,024 |
|
Accrued and other current liabilities |
|
19,383,111 |
|
|
16,138,909 |
|
Lease liabilities, short-term |
|
3,973,920 |
|
|
3,187,435 |
|
Accrued employee benefits |
|
11,412,697 |
|
|
9,472,651 |
|
Total current liabilities |
|
40,242,715 |
|
|
36,224,019 |
|
Lease liabilities |
|
21,158,241 |
|
|
19,955,186 |
|
|
|
|
|
|
|
|
Total liabilities |
|
61,400,956 |
|
|
56,179,205 |
|
Stockholders’ equity: |
|
|
Common stock, $0.0001 par value: 100,000,000 shares authorized;
66,777,737 and 55,507,497 shares issued and outstanding at June 30,
2020 and December 31, 2019, respectively |
|
6,678 |
|
|
5,551 |
|
Additional paid-in capital |
|
1,199,576,320 |
|
|
904,971,772 |
|
Accumulated deficit |
|
(821,221,229 |
) |
|
(710,098,369 |
) |
Accumulated comprehensive income |
|
1,168,099 |
|
|
128,317 |
|
Total stockholders’ equity |
|
379,529,868 |
|
|
195,007,271 |
|
Total liabilities and
stockholders’ equity |
$ |
440,930,824 |
|
$ |
251,186,476 |
|
|
|
|
|
|
|
|
|
|
|
(1) The condensed consolidated balance sheets at June 30, 2020
and December 31, 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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