05/10/2021 | Press release | Distributed by Public on 05/10/2021 05:33
CAPLYTA supplemental new drug applications (sNDAs) for the treatment of bipolar depression in adults as both monotherapy and adjunctive treatment with lithium or valproate have been accepted for review by the FDA, with a PDUFA target action date of December 17, 2021.
First quarter CAPLYTA total prescriptions (TRx) increased 23% versus the previous quarter.
Total revenues for the first quarter were $15.9 million. CAPLYTA achieved net product revenues of $15.6 million for the first quarter.
Introduced ITI-1284 ODT-SL, a deuterated form of lumateperone delivered sublingually as an orally disintegrating tablet.
NEW YORK, May 10, 2021 (GLOBE NEWSWIRE) -- 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, 2021 and provided a corporate update.
'The acceptance of our sNDAs by the FDA is an important step towards a potential new treatment option for patients living with bipolar depression, a condition with a limited number of approved treatments. While preparing for this significant opportunity, our team will continue to execute on our commercial objectives for CAPLYTA and advance our robust pipeline,' said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies.
First Quarter Financial Highlights:
COMMERCIAL HIGHLIGHTS
CLINICAL HIGHLIGHTS
Lumateperone - Bipolar Depression Program:
Other Lumateperone Programs
CAPLYTA- Schizophrenia
Other Programs
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 3244409. 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:
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.
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 regarding the sNDAs, including 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; the potential approval by the FDA of the sNDAs for lumateperone for the treatment of bipolar depression; the potential timing of review and action by the FDA with respect to the sNDAs; 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 ITI-333 clinical trial; our development plans for our PDE program, including ITI-214, and the potential benefits of PDE1 inhibition; 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 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; 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 Relations
646-440-9333
Burns McClellan, Inc.Lisa Burns
[email protected]
212-213-0006
MEDIA INQUIRIES:
Ana Fullmer
Corporate Media Relations W2Owcg
[email protected]
202-507-0130
INTRA-CELLULAR THERAPIES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Three Months Ended March 31, | ||||||
2021 |
2020 |
|||||
Revenues | ||||||
Product sales, net | $ | 15,578,905 | $ | 882,516 | ||
Grant revenue | 299,424 | 200,963 | ||||
Total revenues | 15,878,329 | 1,083,479 | ||||
Operating expenses: | ||||||
Cost of product sales | 1,455,215 | 69,311 | ||||
Research and development | 15,058,168 | 16,003,326 | ||||
Selling, general and administrative | 52,583,639 | 34,096,366 | ||||
Total operating expenses | 69,097,022 | 50,169,003 | ||||
Loss from operations | (53,218,693 | ) | (49,085,524 | ) | ||
Interest income | 483,750 | 1,678,203 | ||||
Loss before provision for income taxes | (52,734,943 | ) | (47,407,321 | ) | ||
Income tax expense | 5,000 | 3,281 | ||||
Net loss | $ | (52,739,943 | ) | $ | (47,410,602 | ) |
Net loss per common share: | ||||||
Basic & Diluted | $ | (0.65 | ) | $ | (0.73 | ) |
Weighted average number of common shares: | ||||||
Basic & Diluted | 80,946,450 | 65,106,103 |
(1) The condensed consolidated statements of operations for the quarters ended March 31, 2021 and 2020 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
March 31, 2021 |
December 31, 2020 |
|||||
(Unaudited) | ||||||
Assets | ||||||
Current assets: | ||||||
Cash and cash equivalents | $ | 129,979,888 | $ | 60,045,933 | ||
Investment securities, available-for-sale | 481,984,786 | 597,402,126 | ||||
Restricted cash | 1,400,000 | 1,400,000 | ||||
Accounts receivable, net less allowance of $120,000 at March 31, 2021 and December 31, 2020 | 13,661,992 | 10,764,583 | ||||
Inventory | 7,579,393 | 7,056,385 | ||||
Prepaid expenses and other current assets | 14,494,384 | 14,235,455 | ||||
Total current assets | 649,100,443 | 690,904,482 | ||||
Property and equipment, net | 1,871,338 | 1,998,346 | ||||
Right of use assets, net | 23,430,703 | 24,324,762 | ||||
Other assets | 86,084 | 86,084 | ||||
Total assets | $ | 674,488,568 | $ | 717,313,674 | ||
Liabilities and stockholders' equity | ||||||
Current liabilities: | ||||||
Accounts payable | $ | 8,720,957 | $ | 5,501,825 | ||
Accrued and other current liabilities | 13,491,620 | 10,902,117 | ||||
Lease liabilities, short-term | 5,573,240 | 5,541,802 | ||||
Accrued employee benefits | 11,915,893 | 14,907,479 | ||||
Total current liabilities | 39,701,710 | 36,853,223 | ||||
Lease liabilities | 22,637,100 | 23,600,347 | ||||
Total liabilities | 62,338,810 | 60,453,570 | ||||
Stockholders' equity: | ||||||
Common stock, $0.0001 par value: 100,000,000 shares authorized; 81,133,849 and 80,142,797 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively | 8,113 | 8,046 | ||||
Additional paid-in capital | 1,601,739,075 | 1,593,475,506 | ||||
Accumulated deficit | (989,843,975 | ) | (937,104,032 | ) | ||
Accumulated comprehensive income | 246,545 | 480,584 | ||||
Total stockholders' equity | 612,149,758 | 656,860,104 | ||||
Total liabilities and stockholders' equity | $ | 674,488,568 | $ | 717,313,674 | ||
(1) The condensed consolidated balance sheets at March 31, 2021 and December 31, 2020 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.
Source: Intra-Cellular Therapies Inc.