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Our business is subject to the following principal risks and uncertainties: Risks Related to our Business and Industry We are dependent on the commercial success of Fanapt , HETLIOZ , PONVORY and NEREUS TM (our commercial products).
Future performance of our commercial products may be impacted by a number of factors including competing products or unanticipated safety issues.
The FDA may not approve our New Drug Application (NDA) filing for the use of NEREUS TM for patients with gastroparesis.
We might not obtain regulatory approvals to commercialize any current product candidates, including Bysanti TM and imsidolimab.
Disruptions at the FDA and other government agencies could prevent new or modified products from being developed, approved or commercialized in a timely manner.
Our business may be materially adversely affected by duties, tariffs and other trade barriers and retaliatory countermeasures.
We rely on, and will continue to rely on, outsourcing arrangements for many of our activities, including preclinical and clinical development and supply of our commercial and other products.
We may experience disruptions to our commercial products supply chains.
Our products may cause undesirable side effects or have other properties that could delay, prevent or result in the revocation of their regulatory approval or limit their marketability.
PONVORY for RMS (tablets) PONVORY is a product approved for the treatment of RMS, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease, in adults.
REMOVED
Food and Drug Administration (FDA) for HETLIOZ beyond the currently approved indications; our ability to increase market awareness of Non-24 and SMS and market acceptance of HETLIOZ ; our ability to commercialize PONVORY (ponesimod) tablets for the treatment of adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease in the U.S.
Our business is subject to the following principal risks and uncertainties: Risks Related to our Business and Industry We are dependent on the commercial success of Fanapt , HETLIOZ and PONVORY .
Future performance of Fanapt , HETLIOZ and PONVORY may be impacted by a number of factors including competing products or unanticipated safety issues.
The FDA may not approve our New Drug Application (NDA) filing for the use of tradipitant for patients with gastroparesis or the FDA may determine that our clinical trial results for tradipitant for the treatment of gastroparesis do not demonstrate adequate safety and substantial evidence of efficacy.
The FDA may not accept our NDA filing for the use of tradipitant for patients with motion sickness or the FDA may determine that our clinical trial results for tradipitant for the treatment of motion sickness do not demonstrate adequate safety and substantial evidence of efficacy.
We rely on, and will continue to rely on, outsourcing arrangements for many of our activities, including preclinical and clinical development and supply of Fanapt , HETLIOZ , HETLIOZ LQ , PONVORY and our other products.
We may experience disruptions to our Fanapt , HETLIOZ , HETLIOZ LQ or PONVORY supply chains.
FDA and foreign regulatory approval of our products is uncertain.
Our commercial portfolio is currently comprised of three products: Fanapt for the acute treatment of manic or mixed episodes associated with bipolar I disorder and the treatment of schizophrenia, HETLIOZ for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) and for the treatment of nighttime sleep disturbances in Smith-Magenis syndrome (SMS) and PONVORY for the treatment of relapsing forms of multiple sclerosis (RMS) including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.
Commercialized Products Our commercial product portfolio consists of: Product Indication 2024 Net Sales (in millions) Geography Schizophrenia (tablets) Manic or mixed episodes associated with bipolar I disorder (tablets) $94.3 United States Israel (schizophrenia only) Non-24 (capsules) Nighttime sleep disturbances in SMS (capsules and HETLIOZ LQ oral suspension) $76.7 United States Europe (Non-24 in blind patients only) Relapsing forms of multiple sclerosis (tablets) $27.8 United States Canada Fanapt for schizophrenia (tablets) Fanapt is a product approved for the treatment of schizophrenia.