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CAPLYTA net product revenues for the third quarter 2022 were $71.9 million, compared to $21.6 million for the same period in 2021, representing a 233% increase over the same period in 2021 and a 30% increase over the second quarter 2022
Third quarter 2022 CAPLYTA total prescriptions increased 220%, versus the same period in 2021 and 26% sequentially versus the second quarter 2022
NEW YORK, Nov. 03, 2022 (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 third quarter ended September 30, 2022 and provided a corporate update.
“The successful launch of CAPLYTA continues with another quarter of strong revenue growth. In addition to our efforts to fuel continued commercial success, we are making investments to broaden CAPLYTA’s indications and advance our pipeline,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies.
THIRD QUARTER FINANCIAL HIGHLIGHTS
COMMERCIAL HIGHLIGHTS
CLINICAL HIGHLIGHTS
Clinical Programs:
Presentations:
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/BIc63e50ba892948f5932b126e73007d48 ). 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 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:
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. 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. Breastfeeding is not recommended. 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.
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; the goals of our development programs; our beliefs about the potential utility of our product candidates; future financial results; 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 Relations
646-440-9333
Burns McClellan, Inc.
Lisa Burns
cradinovic@burnsmc.com
212-213-0006
INTRA-CELLULAR THERAPIES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands except share and per share amounts) (Unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||
| Revenues | ||||||||||||
| Product sales, net | $ | 71,870 | $ | 21,606 | $ | 161,699 | $ | 56,192 | ||||
| Grant revenue | — | 601 | 746 | 1,940 | ||||||||
| Total revenues | 71,870 | 22,207 | 162,445 | 58,132 | ||||||||
| Operating expenses: | ||||||||||||
| Cost of product sales | 5,850 | 2,001 | 13,655 | 5,496 | ||||||||
| Selling, general and administrative | 88,375 | 70,498 | 264,151 | 192,933 | ||||||||
| Research and development | 33,274 | 27,032 | 100,853 | 59,387 | ||||||||
| Total operating expenses | 127,499 | 99,531 | 378,659 | 257,816 | ||||||||
| Loss from operations | (55,629 | ) | (77,324 | ) | (216,214 | ) | (199,684 | ) | ||||
| Interest income | 2,122 | 393 | 3,990 | 1,298 | ||||||||
| Loss before provision for income taxes | (53,507 | ) | (76,931 | ) | (212,224 | ) | (198,386 | ) | ||||
| Income tax (expense) benefit | (1 | ) | 23 | (6 | ) | (6 | ) | |||||
| Net loss | $ | (53,508 | ) | $ | (76,908 | ) | $ | (212,230 | ) | $ | (198,392 | ) |
| Net loss per common share: | ||||||||||||
| Basic & Diluted | $ | (0.57 | ) | $ | (0.95 | ) | $ | (2.26 | ) | $ | (2.44 | ) |
| Weighted average number of common shares: | ||||||||||||
| Basic & Diluted | 94,516,794 | 81,354,724 | 93,809,124 | 81,178,482 | ||||||||
The condensed consolidated statements of operations for the three and nine months ended September 30, 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)
| September 30, 2022 | December 31, 2021 | |||||
| (Unaudited) | ||||||
| Assets | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 135,358 | $ | 92,365 | ||
| Investment securities, available-for-sale | 493,383 | 319,968 | ||||
| Restricted cash | 1,750 | 1,400 | ||||
| Accounts receivable, net | 61,538 | 20,156 | ||||
| Inventory | 23,597 | 7,948 | ||||
| Prepaid expenses and other current assets | 44,130 | 25,444 | ||||
| Total current assets | 759,756 | 467,281 | ||||
| Property and equipment, net | 2,084 | 1,791 | ||||
| Right of use assets, net | 20,073 | 20,764 | ||||
| Other assets | 86 | 86 | ||||
| Total assets | $ | 781,999 | $ | 489,922 | ||
| Liabilities and stockholders’ equity | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 14,219 | $ | 8,691 | ||
| Accrued and other current liabilities | 14,850 | 11,073 | ||||
| Accrued customer programs | 19,946 | 5,964 | ||||
| Accrued employee benefits | 21,150 | 20,897 | ||||
| Lease liabilities, short-term | 7,245 | 6,732 | ||||
| Total current liabilities | 77,410 | 53,357 | ||||
| Lease liabilities | 19,167 | 18,675 | ||||
| Total liabilities | 96,577 | 72,032 | ||||
| Stockholders’ equity: | ||||||
| Common stock, $0.0001 par value: 175,000,000 shares authorized at September 30, 2022 and December 31, 2021, 94,701,662 and 81,886,965 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively | 9 | 8 | ||||
| Additional paid-in capital | 2,124,369 | 1,639,476 | ||||
| Accumulated deficit | (1,433,460 | ) | (1,221,230 | ) | ||
| Accumulated comprehensive loss | (5,496 | ) | (364 | ) | ||
| Total stockholders’ equity | 685,422 | 417,890 | ||||
| Total liabilities and stockholders’ equity | $ | 781,999 | $ | 489,922 | ||
The condensed consolidated balance sheets at September 30, 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.