ITEM 8.01 Other Events.
On March 23, 2020, Intra-Cellular Therapies, Inc. (the "Company") announced that
CAPLYTA (lumateperone) is now available to pharmacies in the U.S. CAPLYTA is an
oral, once daily medicine approved for the treatment of schizophrenia in adults.
The Company's press release announcing the approval is filed as Exhibit 99.1 to
this Current Report on Form 8-K and is incorporated herein by reference.
In addition, the global spread of a novel strain of coronavirus, SARS-CoV-2,
which causes coronavirus disease 2019 (COVID-19), as well as the Company's
actions to protect the health of its employees and the healthcare providers and
patients it serves, and their families and communities, create a number of risks
and uncertainties to the Company's business which could have a material adverse
effect on its business, results of operations and financial condition, described
further below:
The outbreak of the novel strain of coronavirus, SARS-CoV-2, or similar public
health crises, could have a material adverse impact on our business, financial
condition and results of operations, including our commercial operations and
sales, clinical trials and preclinical studies.
Public health crises, such as pandemics or similar outbreaks, could adversely
impact our business. In December 2019, a novel strain of coronavirus,
SARS-CoV-2, which causes coronavirus disease 2019 (COVID-19), surfaced in Wuhan,
China. Since then, SARS-CoV-2 and COVID-19 have spread to multiple countries,
including the United States. The COVID-19 pandemic is evolving, and to date has
led to the implementation of various responses, including government-imposed
quarantines, travel restrictions and other public health safety measures. In
response to the spread of SARS-CoV-2 and COVID-19, we have instructed the
majority of our office-based employees to work from home. In connection with our
commercial launch of CAPLYTA, which is approved by U.S. Food and Drug
Administration for the treatment of schizophrenia in adults, our commercial
organization and sales force and medical organization may have significantly
reduced personal interactions with physicians and customers and increasingly
conduct promotional activities virtually, and we may elect to cease in-person
interactions with physicians and customers entirely for some period of time in
the interest of employee and community safety. As a result of the COVID-19
outbreak, or similar pandemics, we may experience disruptions that could
severely impact our business, including our ability to successfully
commercialize our only commercial product, CAPLYTA, in the U.S., and these
disruptions could negatively impact our sales of CAPLYTA. Business interruptions
from the current or future pandemics may also adversely impact the third parties
we rely on to sufficiently manufacture CAPYLTA and to produce our product
candidates in quantities we require, which may impair the commercialization and
our research and development activities.
We are currently conducting clinical trials for our product candidates in many
countries, including the United States, Europe and Russia and may expand to
other geographies. Timely enrollment of, completion of and reporting on our
clinical trials is dependent upon these global clinical trial sites which are,
or in the future may be, adversely affected by the COVID-19 outbreak or other
pandemics. Some factors from the COVID-19 outbreak that may adversely affect the
timing and conduct of our clinical trials and adversely impact our business
generally, include but are not limited to delays or difficulties in clinical
site initiation, diversion of healthcare resources away from clinical trials to
pandemic concerns, limitations on travel, regulatory delays and supply chain
disruptions.
The COVID-19 outbreak continues to rapidly evolve, and the extent to which the
outbreak impacts our business, including our commercial results, clinical
trials, and preclinical studies will depend on future developments, which are
highly uncertain.
ITEM 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit
Number Description
99.1 Press release dated March 23, 2020
104 Cover Page Interactive Data File (embedded within the Inline XBRL
document)
The press release may contain hypertext links to information on our website. The
information on our website is not incorporated by reference into this Current
Report on Form 8-K and does not constitute a part of this Form 8-K.
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