What changed in this filing

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Item 1. Business

2026-02-12 compared with 2025-02-14 · 235 added, 201 removed, 851 unchanged (34% of the section changed)

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We are committed to the use of technologies that support sound science, including genetics and genomics, in drug discovery, clinical trials and the commercial positioning of our products.

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.

Our commercial portfolio is currently comprised of four 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), PONVORY ® for the treatment of relapsing forms of multiple sclerosis (RMS) including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease and NEREUS TM for the prevention of vomiting induced by motion (collectively, our commercial products).

HETLIOZ ® is the first product approved by the United States Food and Drug Administration (FDA) for patients with Non-24 and for patients with SMS.

In addition, we have a number of drugs and/or additional indications for current products in development, including:

• Fanapt ® (iloperidone) long acting injectable (LAI) formulation for the treatment of schizophrenia;

• Bysanti TM (milsaperidone), the active metabolite of Fanapt ® (iloperidone), for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia and major depressive disorder (MDD);

• Fanapt ® (iloperidone) long acting injectable (LAI) formulation for the treatment of schizophrenia and hypertension;

• Bysanti TM (milsaperidone), the active metabolite of Fanapt ® , for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia and major depressive disorder (MDD);

• HETLIOZ ® (tasimelteon) for the treatment of jet lag disorder, insomnia, pediatric insomnia, delayed sleep phase disorder (DSPD) and pediatric Non-24;

• PONVORY ® (ponesimod) for the treatment of psoriasis and ulcerative colitis;

• Tradipitant (VLY-686), a small molecule neurokinin-1 (NK-1) receptor antagonist, for the treatment of gastroparesis, motion sickness and atopic dermatitis;

• NEREUS TM (tradipitant) for the prevention of vomiting induced by GLP-1 receptor agonists, the treatment of gastroparesis and the treatment of atopic dermatitis;

• Imsidolimab, an IL-36R antagonist, for the treatment of generalized pustular psoriasis (GPP);

• VTR-297, a small molecule histone deacetylase (HDAC) inhibitor for the treatment of onychomycosis and hematologic malignancies and with potential use as a treatment for several oncology indications;

• VTR-297, a small molecule histone deacetylase (HDAC) inhibitor for the treatment of hematologic malignancies and onychomycosis and with potential use as a treatment for several oncology indications;

• Portfolio of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) activators and inhibitors, including VSJ-110 for the treatment of dry eye and ocular inflammation and VPO-227 for the treatment of secretory diarrhea disorders, including cholera;

• VQW-765, a small molecule nicotinic acetylcholine receptor partial agonist, for the treatment of social/performance anxiety and psychiatric disorders;

• VQW-765, a small molecule alpha-7 nicotinic acetylcholine receptor partial agonist, for the treatment of social/performance anxiety and psychiatric disorders;

• Antisense oligonucleotide (ASO) molecules, including VCA-894A for the treatment of Charcot-Marie-Tooth Disease, Type 2S (CMT2S), caused by cryptic slice site variants within the IGHMBP2 gene and VGT-1849A for the treatment of polycythemia vera (PV), a form of a rare hematologic malignancy.

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The key elements of our strategy to accomplish this goal are to:

• Maximize the commercial success of Fanapt ® , HETLIOZ ® , and PONVORY ® ;

• Maximize the commercial success of our commercial products;

• Enter into strategic partnerships to supplement our capabilities and to extend our commercial reach;

• Pursue the clinical development and regulatory approval of our products, including tradipitant;

• Pursue the clinical development and regulatory approval of our products;

• Apply our pharmacogenetics and pharmacogenomics expertise to differentiate our products;

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$27.4 United States

Prevention of vomiting induced by motion (capsules)

$— United States

Fanapt ® for schizophrenia (tablets)

Fanapt ® is a product approved for the treatment of schizophrenia.

In May 2009, the FDA granted U.S.

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Atypical antipsychotics are generally regarded as having improved side effect profiles and efficacy relative to typical antipsychotics.

See Competition below for a discussion of commonly prescribed atypical antipsychotics in addition to Fanapt ® .

See Competition below for a discussion of commonly prescribed antipsychotics in addition to Fanapt ® .

Fanapt ® for bipolar I disorder (tablets)

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People with bipolar disorders generally have periods of normal mood as well.

See Competition below for a discussion of commonly prescribed atypical antipsychotics in addition to Fanapt ® .

See Competition below for a discussion of commonly prescribed antipsychotics in addition to Fanapt ® .

HETLIOZ ® for Non-24 (capsules)

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See Competition below for a discussion of commonly prescribed drugs for patients with sleep disorders.

PONVORY ® for relapsing multiple sclerosis (tablets)

PONVORY ® is a product approved for the treatment of relapsing forms of MS (RMS), including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease, in adults.

In December 2023, we purchased the right to market and sell PONVORY ® in the U.S.

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.

In December 2023, we purchased the rights to market and sell PONVORY ® in the U.S.

and Canadian markets from Actelion Pharmaceuticals Ltd.

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Health Canada approved PONVORY ® for the treatment of RMS in April 2021.

MS is a chronic autoimmune inflammatory disease of the central nervous system (CNS) in which immune cells attack myelin (the protective casing that insulates nerve cells), damaging or destroying it and causing inflammation.

Multiple sclerosis (MS) is a chronic autoimmune inflammatory disease of the central nervous system (CNS) in which immune cells attack myelin (the protective casing that insulates nerve cells), damaging or destroying it and causing inflammation.

This affects how the CNS processes information and communicates with the rest of the body, causing the neurologic signs and symptoms of MS.

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PONVORY ® was launched commercially in the U.S.

in April 2021 and in Canada in November 2021 by one of the Johnson & Johnson Companies.

in April 2021 by one of the Johnson & Johnson Companies.

There are a number of drugs approved and prescribed to treat patients with MS.

See Competition below for a discussion of these commonly prescribed drugs.

NEREUS TM for motion sickness (capsules)

In December 2025, NEREUS TM was approved in the U.S.

for the prevention of vomiting induced by motion in adults.

Motion sickness is a disorder that arises often as a response to real or perceived movement, as occurring during vehicular travel.

Vomiting is the most disturbing symptom of motion sickness, although the disorder is often accompanied by a constellation of symptoms that includes nausea, sweating, pallor, headache and anorexia.

Motion sickness is one of the most prevalent episodic disorders in the world, whose prevalence has dramatically increased with world population mobility over the last 100 years.

Approximately 30% of the general population is reported to suffer from motion sickness under ordinary travel conditions that include sea, air and land travel.

See Competition below for a discussion of commonly prescribed drugs in addition to NEREUS TM .

Research and Development

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We initiated a Phase III program for the LAI formulation of Fanapt ® in the fourth quarter of 2024.

Bysanti TM (Milsaperidone)

In 2021, we initiated a bioequivalence study of Fanapt ® and milsaperidone, the active metabolite of iloperidone.

We believe that milsaperidone represents a potential improvement over the clinical profile of Fanapt ® and has the potential to create sustained, long-term value in the treatment of psychiatric disorders, including bipolar I disorder and schizophrenia, the indications already approved for Fanapt ® , as well as new indications such as MDD.

We initiated a Phase III clinical study for milsaperidone for MDD in the fourth quarter of 2024.

The Phase III study is ongoing.

Fanapt ® for hypertension (LAI)

A clinical study of the long acting injectable formulation of Fanapt ® in people with treatment-resistant hypertension is ongoing and enrolling patients.

Bysanti TM for bipolar I disorder and schizophrenia

In 2021, we initiated a bioequivalence study of Fanapt ® and Bysanti TM , the active metabolite of iloperidone.

We believe that Bysanti TM represents a potential improvement over the clinical profile of Fanapt ® and has the potential to create sustained, long-term value in the treatment of psychiatric disorders, including bipolar I disorder and schizophrenia, the indications already approved for Fanapt ® .

The FDA accepted our New Drug Application (NDA) for Bysanti TM for the treatment of bipolar I disorder and schizophrenia for filing in May 2025 and set a PDUFA target action date of February 21, 2026.

Bysanti TM for MDD

We initiated a Phase III clinical study for Bysanti TM as a once-daily adjunctive treatment for MDD in the fourth quarter of 2024, with results expected in 2026.

The Phase III clinical study is enrolling patients.

HETLIOZ ® for jet lag disorder

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The results support the previously reported pivotal JET5 and JET8 Phase III clinical studies, which demonstrated improvements in patients who experienced circadian advances of five and eight hours, respectively.

Additionally, in September 2018, we announced results from a driving study, which demonstrated that tasimelteon did not impair measures of driving performance.

Additionally, in September 2018, we announced results from a driving study, which demonstrated that HETLIOZ ® did not impair measures of driving performance.

The FDA accepted the filing of our sNDA for HETLIOZ ® for the treatment of jet lag disorder in December 2018.

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In January 2025, the DC Circuit held an oral argument on the petition.

Our petition remains pending.

In August 2025, the DC Circuit issued a decision in our favor against the FDA, setting aside the FDA’s refusal to hold a hearing on our sNDA for HETLIOZ ® for the treatment of jet lag disorder and remanding the case back to the FDA.

In October 2025, we announced that we entered into a collaborative framework with the FDA for the resolution of certain of our disputes regarding HETLIOZ ® and NEREUS TM (the FDA Agreement), pursuant to which the FDA agreed to conduct an expedited re-review of the sNDA and we sought a temporary abeyance in these proceedings.

In January 2026, the FDA notified us that, following its re-review of the sNDA, it has determined that the sNDA cannot be approved in its current form.

In January 2026, we requested that the FDA Commissioner resume hearing proceedings.

Jet lag disorder is a common circadian disorder frequently observed in millions of travelers who cross multiple time zones.

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Two studies of transient insomnia induced by phase advance of the sleep-wake cycle were also conducted with five-hour and eight-hour phase advance, which showed a significant effect the first night in improving sleep parameters.

In July 2023, the FDA accepted our sNDA for HETLIOZ ® in insomnia for filing and set a target action date of March 4, 2024 under the Prescription Drug User Fee Act (PDUFA) for its decision.

In July 2023, the FDA accepted our sNDA for HETLIOZ ® in insomnia for filing and set a PDUFA target action date of March 4, 2024 for its decision.

On March 4, 2024, we received a CRL from the FDA.

In June 2024, we received a Notice of Opportunity for a Hearing, and we accepted the opportunity for a hearing in July 2024.

In August 2024, we filed for summary judgment requesting approval or a hearing on approvability of tasimelteon to treat insomnia associated with difficulties with sleep initiation.

In August 2024, we filed for summary judgment requesting approval or a hearing on approvability of HETLIOZ ® to treat insomnia associated with difficulties with sleep initiation.

In October 2024, we received a Proposed Order denying a hearing on approvability for the insomnia sNDA and we submitted a response to the Proposed Order in December 2024.

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DSPD is likely the most prevalent circadian-rhythm sleep disorder, affecting approximately 1% of the population, and there is no FDA approved treatment at this time.

The mechanism of action of PONVORY ® makes it also a potential therapeutic candidate for the treatment of a diverse group of inflammatory/autoimmune disorders including but not limited to ulcerative colitis, psoriasis, Crohn’s disease, atopic dermatitis, eosinophilic esophagitis and alopecia areata.

In a randomized placebo controlled clinical study, PONVORY ® has been shown to reduce the symptoms and signs of psoriasis.

Investigational New Drug (IND) applications for PONVORY ® in the treatments of psoriasis and ulcerative colitis were accepted by the FDA in the fourth quarter of 2024.

HETLIOZ ® for pediatric Non-24

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A pharmacokinetic study of the HETLIOZ ® pediatric liquid formulation was completed in the first quarter of 2018.

Tradipitant for gastroparesis

In December 2018, we announced results from a Phase II randomized clinical study (2301) of tradipitant as a monotherapy in the treatment of gastroparesis.

PONVORY ® for psoriasis

In a randomized placebo controlled clinical study, PONVORY ® has been shown to reduce the symptoms and signs of psoriasis.

The Investigational New Drug (IND) application for PONVORY ® for the treatment of psoriasis was accepted by the FDA in the fourth quarter of 2024.

A Phase III clinical study of PONVORY ® for the treatment of psoriasis is ongoing.

PONVORY ® for ulcerative colitis

The IND application for PONVORY ® in the treatment of ulcerative colitis was accepted by the FDA in the fourth quarter of 2024.

A Phase III clinical study of PONVORY ® for the treatment of ulcerative colitis is ongoing.

NEREUS TM for vomiting induced by GLP-1 receptor agonists

In November 2025, we announced results from a randomized controlled clinical study evaluating NEREUS TM for the prevention of nausea and vomiting induced by GLP-1 receptor agonist Wegovy ® in overweight and obese adults.

This study met its primary and secondary endpoints, demonstrating the ability for NEREUS TM to significantly mitigate GLP-1 induced nausea and vomiting.

This study, which pre-treated patients with either NEREUS TM or placebo before administering a 1 mg injection of Wegovy ® , a dose that normally takes 9 weeks of titration to reach, showed a 50% relative reduction in symptoms among the patients treated with NEREUS TM .

NEREUS TM demonstrated a favorable safety profile consistent with previous studies with no new safety signals observed.

A Phase III program is anticipated to initiate in the first half of 2026, positioning NEREUS TM as a key adjunct to improve outcomes in GLP-1 agonist treatments.

NEREUS TM for gastroparesis

In December 2018, we announced results from a Phase II randomized clinical study (2301) of NEREUS TM as a monotherapy in the treatment of gastroparesis.

Several symptom severity scales were used to assess gastroparesis symptoms, including the Gastroparesis Symptom Index (GCSI), Patients Assessment of Upper Gastrointestinal Disorders-Symptoms (PAGI-SYM), and Patient Global Impression of Change (PGI-C) as well as a Clinician Global Impression of Severity (CGI-S).

Tradipitant met the primary endpoint of the study of change in nausea score as measured by patient daily diaries and also met the related endpoint of improvement in the number of nausea free days.

Tradipitant also showed significant improvement in most of the secondary endpoints studied, including several key scales reflecting overall gastroparesis symptoms, specifically GCSI, PAGI-SYM, CGI-S, and PGI-C.

In February 2022, we announced results from our Phase III clinical study, VP-VLY-686-3301, evaluating the efficacy and safety of tradipitant in treating the symptoms of gastroparesis.

NEREUS TM met the primary endpoint of the study of change in nausea score as measured by patient daily diaries and also met the related endpoint of improvement in the number of nausea free days.

NEREUS TM also showed significant improvement in most of the secondary endpoints studied, including several key scales reflecting overall gastroparesis symptoms, specifically GCSI, PAGI-SYM, CGI-S, and PGI-C.

In February 2022, we announced results from a Phase III clinical study (3301) evaluating the efficacy and safety of NEREUS TM in treating the symptoms of gastroparesis.

The study did not meet its prespecified primary endpoint, which was the difference between drug and placebo on the change of the severity of nausea from baseline at week 12 of treatment.

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When restricting the analysis in the group of patients that used no rescue medications at baseline and adjusting for poor compliance, we identified strong evidence of a drug effect across a number of symptoms and across the duration of the study, including a significant and meaningful effect at the prespecified primary endpoint of nausea change at week 12.

The FDA may not view this data as constituting substantial evidence of efficacy for tradipitant in any indication for the treatment of gastroparesis or its symptoms, for any length of treatment.

On September 18, 2024, the FDA informed us that it did not view this data as constituting substantial evidence of efficacy for NEREUS TM in

any indication for the treatment of gastroparesis or its symptoms, for any length of treatment.

The open-label phase of the study remains open.

We believe that tradipitant has a well-established safety profile, as demonstrated by the results of extensive testing in animals and humans.

We believe that NEREUS TM has a well-established safety profile, as demonstrated by the results of extensive testing in animals and humans.

Despite these results, however, the FDA informed us in December 2018 that in order to treat patients beyond 12 weeks, we would have to conduct a nine-month non-rodent chronic toxicity study.

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The non-rodent study required by the FDA necessitates the sacrifice of dozens of animals and we have disputed the necessity of a nine-month non-rodent chronic toxicity study.

In February 2019, we filed a lawsuit in the U.S.

District Court for the District of Columbia (DC District Court) challenging the FDA’s position, but we ultimately did not prevail.

Despite our disagreement with the FDA, the preclinical package has allowed us to continue to conduct all of the efficacy studies necessary for New Drug Application (NDA) filing.

Moreover, in July 2020, the FDA authorized tradipitant through an expanded access program (EAP) for a single patient.

An EAP allows a patient to request the use of tradipitant, prior to NDA approval, for up to six months with an option to request renewal.

Since then, certain patients who experienced a benefit in tradipitant studies have requested and received expanded access, while others have been denied treatment under the EAP.

In February 2019, we filed a lawsuit in the DC District Court challenging the FDA’s position, but we ultimately did not prevail.

Despite our disagreement with the FDA, the preclinical package has allowed us to continue to conduct all of the efficacy studies necessary for NDA filing.

Moreover, in July 2020, the FDA authorized NEREUS TM through an expanded access program (EAP) for a single patient.

An EAP allows a patient to request the use of NEREUS TM , prior to NDA approval, for up to six months with an option to request renewal.

Since then, certain patients who experienced a benefit in NEREUS TM studies have requested and received expanded access, while others have been denied treatment under the EAP.

The EAP is ongoing and a number of patients have initiated treatment.

Although this EAP is not intended for data collection, we collect safety data from this cohort of expanded access patients and included this data in the NDA that we submitted for tradipitant for patients with gastroparesis.

In December 2023, the FDA accepted our NDA for tradipitant in gastroparesis for filing and set a PDUFA target action date of September 18, 2024.

On September 18, 2024, we received a CRL from the FDA.

In January 2025, we received a Notice of Opportunity for a Hearing, and we have accepted the opportunity for a hearing.

Tradipitant is the first novel drug to be accepted for review by the FDA for gastroparesis in over 30 years and, if approved, will be the first novel drug to be approved by the FDA for the treatment of gastroparesis in over 40 years.

The lack of long-term (i.e., more than 12 weeks in humans) safety data would likely impact the FDA’s willingness to approve tradipitant for a chronic indication.

Although this EAP is not intended for data collection, we collect safety data from this cohort of expanded access patients and included this data in the NDA that we submitted for NEREUS TM for patients with gastroparesis.

The lack of long-term (i.e., more than 12 weeks in humans) safety data would likely impact the FDA’s willingness to approve NEREUS TM for a chronic indication.

However, because long-term safety data is not normally a requirement for short-term indications, and with a preclinical profile that has not precluded clinical development, we believe the package was complete for any NDA filing to treat patients for 12 weeks or less.

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While this short-term indication is not preferred, we would consider accepting this limited indication while continuing to pursue a chronic indication.

However, the FDA may

not deem the safety information sufficient even for a short-term indication.

However, the FDA may not deem the safety information sufficient even for a short-term indication.

Moreover, FDA authorization of an EAP is not a guarantee of or a step towards obtaining full FDA approval of an NDA.

In December 2023, the FDA accepted our NDA for NEREUS TM in gastroparesis for filing and set a PDUFA target action date of September 18, 2024.

On September 18, 2024, we received a CRL from the FDA.

In January 2025, we received a Notice of Opportunity for a Hearing, and we have accepted the opportunity for a hearing.

NEREUS TM is the first novel drug to be accepted for review by the FDA for gastroparesis in over 30 years and, if approved, will be the first novel drug to be approved by the FDA for the treatment of gastroparesis in over 40 years.

Gastroparesis is a serious medical condition characterized by delayed gastric emptying associated with the symptoms of nausea, vomiting, bloating, fullness after meals and abdominal pain, along with significant impairment of social and occupational functioning.

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to be approximately six million patients, many of whom remain undiagnosed.

Tradipitant for motion sickness

In July 2019, we reported tradipitant was effective in treating motion sickness in a randomized double blind placebo controlled Phase II clinical study conducted in the Pacific Ocean.

The study had two primary endpoints:

percentage of participants vomiting, and Motion Sickness Severity Scale (MSSS) Worst score.

In the overall population, a significantly higher percentage of participants experienced vomiting in the placebo arm as compared to the tradipitant arm.

The MSSS Worst score endpoint also favored tradipitant, but the difference did not reach statistical significance.

The protocol for a pivotal Phase III motion sickness study was discussed with the FDA at the end of Phase II meeting, and the FDA agreed with the adequacy of the program design to support an NDA.

In May 2023, we announced positive results from the first Phase III clinical study of tradipitant in motion sickness, confirming the previously reported results demonstrating that tradipitant is effective in the prevention of vomiting associated with motion sickness.

In May 2024, we announced positive results from the second Phase III study of tradipitant in motion sickness, confirming the previously reported results of two efficacy studies demonstrating that tradipitant is effective in the prevention of vomiting associated with motion sickness.

In addition, we submitted an NDA for tradipitant in the prevention of vomiting associated with motion sickness in the fourth quarter of 2024.

Motion sickness is a disorder that arises often as a response to real or perceived movement, as occurring during vehicular travel.

Vomiting is the most disturbing symptom of motion sickness, although the disorder is often accompanied by a constellation of symptoms that includes nausea, sweating, pallor, headache and anorexia.

Motion sickness is one of the most prevalent episodic disorders in the world, whose prevalence has dramatically increased with world population mobility over the last 100 years.

It is reported that approximately 30% of the general population suffers from motion sickness under ordinary travel conditions that include sea, air and land travel.

Tradipitant for atopic dermatitis

We announced results in September 2017 from a randomized Phase II clinical study of tradipitant as a monotherapy in the treatment of patients with atopic dermatitis.

Tradipitant was shown to improve the intensity of the worst itch patients experienced, as well as atopic dermatitis disease severity.

On the pre-specified primary endpoint of Average Itch Visual Analog Scale (VAS), tradipitant showed improvement over placebo, but this improvement was not significant due to high placebo effect and the lack of sensitivity of this measure.

In June 2018, we initiated EPIONE, a Phase III clinical study of tradipitant for pruritus in atopic dermatitis.

In October 2019, we began enrolling patients in EPIONE 2, a second Phase III clinical study of tradipitant in atopic dermatitis.

NEREUS TM for atopic dermatitis

We announced results in September 2017 from a randomized Phase II clinical study of NEREUS TM as a monotherapy in the treatment of patients with atopic dermatitis.

NEREUS TM was shown to improve the intensity of the worst itch patients experienced, as well as atopic dermatitis disease severity.

On the pre-specified primary endpoint of Average Itch Visual Analog Scale, NEREUS TM showed improvement over placebo, but this improvement was not significant due to high placebo effect and the lack of sensitivity of this measure.

In June 2018, we initiated EPIONE, a Phase III clinical study of NEREUS TM for pruritus in atopic dermatitis.

In October 2019, we began enrolling patients in EPIONE 2, a second Phase III clinical study of NEREUS TM in atopic dermatitis.

We announced results of EPIONE in February 2020.

The EPIONE study did not meet its primary endpoint in reduction of pruritus across the overall study population.

However, the antipruritic effect of tradipitant was robust in the mild atopic dermatitis population.

The EPIONE study continued to demonstrate that tradipitant is safe and well-tolerated.

However, the antipruritic effect of NEREUS TM was robust in the mild atopic dermatitis population.

The EPIONE study continued to demonstrate that NEREUS TM is safe and well-tolerated.

The EPIONE 2 study was placed on hold in 2020.

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Imsidolimab has successfully completed two global Phase III clinical studies for the treatment of GPP.

In January 2025, we entered into an exclusive global license agreement with AnaptysBio, Inc.

(Anaptys) under which we acquired the worldwide rights to develop, manufacture, and commercialize imsidolimab, an IL-36R antagonist.

In December 2025, we submitted the Biologics License Application (BLA) for imsidolimab for the treatment of GPP and requested priority review of the BLA.

GPP is a rare, chronic, systemic autoinflammatory disease that is potentially life-threatening, if left untreated.

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Enrollment in the Phase I/II clinical study (1101) of VTR-297 in hematologic malignancies is ongoing.

VTR-297 is a small molecule HDAC inhibitor with potential use as a treatment for several oncology indications.

In January 2024, the FDA approved our Investigational New Drug (IND) application to evaluate VTR-297 for the treatment of onychomycosis, a fungal infection of the nail.

In January 2024, the FDA approved our IND application to evaluate VTR-297 for the treatment of onychomycosis, a fungal infection of the nail.

The Phase I clinical study for VTR-297 for the treatment of onychomycosis was initiated in April 2024.

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In October 2022, VPO-227 was granted orphan drug designation by the FDA for the treatment of cholera.

We have also received approval to proceed in a Phase I study of VPO-227 for the treatment of cholera in Bangladesh, a country where the treatment of cholera remains a significant and unmet need.

We have also received approval to proceed with a Phase I study of VPO-227 for the treatment of cholera in Bangladesh, a country where the treatment of cholera remains a significant and unmet need.

The Phase I study of VPO-27 for the treatment of cholera in Bangladesh is ongoing.

We are evaluating VQW-765 for the treatment of psychiatric disorders.

In December 2022, we announced results from our Phase II clinical study, VP-VQW-765-2201 (Study 2201), of a single-dose treatment to alleviate acute performance anxiety in social situations.

In December 2022, we announced results from a Phase II clinical study (2201) of a single-dose treatment to alleviate acute performance anxiety in social situations.

In the clinical study, 230 volunteers with prior history of performance anxiety were randomized to receive a single dose of VQW-765 or placebo and were challenged with the standardized Trier Social Stress Test (TSST).

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A significant relationship was also seen between exposure to VQW-765 (amount of drug measured in blood) and the clinical response.

VQW-765 is a Phase II alpha-7 nicotinic acetylcholine receptor partial agonist that we licensed from Novartis on December 31, 2014 pursuant to a settlement agreement.

We have initiated a Phase III program and are enrolling patients.

Other products

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OliPass’ unique OliPass Peptide Nucleic Acids technology provides the delivery platform to enable these gene expression modifications.

ASOs may have broad applicability in addressing a number of disorders, from nervous system treatments to systemic treatments.

ASOs may have broad applicability in addressing a number of disorders, from nervous system treatments to systemic treatments, including treatments for CMT2S and Parkinson’s disease.

In June 2023, VCA-894A, an ASO molecule, was granted orphan designation by the FDA for the treatment of a patient with CMT2S, caused by cryptic splice site variants within IGHMBP2.

In January 2024, we announced that the FDA had approved the Investigational New Drug (IND) application to evaluate VCA-894A for the treatment of a patient with CMT2S.

In January 2024, we announced that the FDA had approved the IND application to evaluate VCA-894A for the treatment of a patient with CMT2S.

CMT2S is a rare subtype of Charcot-Marie-Tooth disease (CMT), an inherited peripheral neuropathy for which there is no available treatment.

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The prevalence of CMT2S is estimated to be less than 1 in 1,000,000 worldwide.

In addition, in December 2024, the FDA granted orphan drug designation for VGT-1849A, an ASO-based JAK2 inhibitor for the treatment of polycythemia vera (PV), a form of a rare hematologic malignancy that is estimated to affect 1 in 2,000 Americans.

Parkinson’s disease, characterized by the progressive loss of dopaminergic neurons in the brain, is the fastest-growing and second most common neurodegenerative disorder worldwide.

Multiple genetic forms of Parkinson’s disease have been identified across the PARK gene family, with SNCA (α-synuclein) being the first gene implicated.

The Ala53Thr (p.A53T) missense mutation in SNCA represents one of the most significant risk factors for early-onset Parkinson's and was the first mutation shown to cause autosomal-dominant Parkinson’s disease.

Current ASO approaches broadly target SNCA irrespective of mutation status, raising concerns about excessive α-synuclein depletion.

We are developing an allele-specific strategy that achieves genotype-selective downregulation of the pathogenic A53T allele while preserving wild-type SNCA expression and function.

We believe that if this approach is validated in the A53T variant, the approach could be extended to target several other SNCA variants associated with autosomal-dominant Parkinson’s disease.

For more detailed information regarding our clinical trial results and regulatory activities for our products, please refer to our SEC filings and press releases, which can be found on the SEC EDGAR website and on our website www.vandapharma.com.

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In the event we terminate our license, or if BMS terminates our license due to our breach, all rights licensed and developed by us under this agreement will revert or otherwise be licensed back to BMS on an exclusive basis.

Tradipitant (VLY-686)

In April 2012, we entered into a license agreement with Eli Lilly and Company (Lilly) pursuant to which we acquired an exclusive worldwide license under certain patents and patent applications, and other licenses to intellectual property, to develop and commercialize an NK-1 receptor antagonist, tradipitant, for all human indications.

Lilly is eligible to receive future payments based upon achievement of specified development, regulatory approval and commercialization milestones as well as tiered-royalties on net sales at percentage rates up to the low double digits.

We have paid Lilly $5.0 million in upfront fees and development milestones, including a $2.0 million development milestone paid in December 2023 for the filing of the first

marketing authorization for tradipitant in the U.S.

As of December 31, 2024, remaining milestones include $10.0 million and $5.0 million milestones for the first approval of a marketing authorization for tradipitant in the U.S.

and the E.U., respectively, and up to $80.0 million for sales milestones.

We are obligated to use commercially reasonable efforts to develop and commercialize tradipitant.

We have paid Lilly $5.0 million in upfront fees and development milestones, including a $2.0 million development milestone paid in December 2023 for the filing of the first marketing authorization for NEREUS TM in the U.S.

In the fourth quarter of 2025, our NDA for the prevention of vomiting induced by motion was approved by the FDA and we accrued $10.0 million as a current liability as of December 31, 2025.

As of December 31, 2025, remaining milestones include a $5.0 million milestone for the first approval of a marketing authorization for NEREUS TM in the E.U.

and up to $80.0 million for sales milestones.

We are obligated to use commercially reasonable efforts to develop and commercialize NEREUS TM .

Either party may terminate the agreement under certain circumstances, including a material breach of the agreement by the other.

In the event that we terminate the agreement, or if Lilly terminates the agreement due to our breach or for certain other reasons set forth in the agreement, all rights licensed and developed by us under the agreement will revert or otherwise be licensed back to Lilly on an exclusive basis, subject to payment by Lilly to us of a royalty on net sales of products that contain tradipitant.

In January 2025, we entered into an exclusive global license agreement with Anaptys under which we acquired the worldwide rights to develop, manufacture, and commercialize imsidolimab, an IL-36R antagonist.

In January 2025, we entered into an exclusive global license agreement with AnaptysBio, Inc.

(Anaptys) under which we acquired the worldwide rights to develop, manufacture and commercialize imsidolimab.

The agreement grants us exclusive rights to imsidolimab, which has successfully completed two global Phase III clinical studies for the treatment of GPP.

Under the terms of the agreement, we made an upfront payment of $10 million to Anaptys and an additional $5 million for existing drug supply.

Anaptys is eligible to receive up to $35 million in future regulatory approval and sales milestones.

Additionally, we are obligated to pay Anaptys a 10% royalty on global net sales of imsidolimab.

Under the terms of the agreement, we made an upfront payment of $10.0 million to Anaptys and an additional $5.0 million for drug supply.

Anaptys is eligible to receive future payments based upon achievement of specified regulatory approval and commercialization milestones as well as a 10% royalty on global net sales.

As of December 31, 2025, remaining milestone obligations include up to $35.0 million in future regulatory approval and sales milestones, including $5.0 million each for the first approval of an application for marketing authorization for imsidolimab in the U.S.

and $25.0 million for a sales milestone.

We are obligated to use commercially reasonable efforts to develop and commercialize imsidolimab.

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Termination will not relieve us of our obligation to pay royalties or other payments owed, if any, to UCSF under the terms of the agreement.

In connection with the settlement agreement with Novartis relating to Fanapt ® , we received an exclusive worldwide license under certain patents and patent applications, and other licenses to intellectual property, to develop and commercialize VQW-765, a Phase II alpha-7 nicotinic acetylcholine receptor partial agonist.

Pursuant to the license agreement, we are obligated to use commercially reasonable efforts to develop and commercialize VQW-765 and are responsible for all development costs.

Pursuant to the license agreement, we are obligated to use commercially reasonable efforts to develop and

commercialize VQW-765 and are responsible for all development costs.

We have no milestone obligations, but Novartis is eligible to receive tiered-royalties on net sales at percentage rates up to the mid-teens.

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Accordingly, securing patents, regulatory data package protection, and other proprietary rights are an essential element of our business strategies.

PONVORY ® , tradipitant and VQW-765 are covered by NCE and other patents and patent applications related to their respective medicinal uses.

In addition, NCE patent protection has been sought for VTR-297 and CFTR activators and inhibitors.

PONVORY ® , NEREUS TM and VQW-765 are covered by NCE exclusivity and other patents and patent applications related to their respective medicinal uses.

In addition, NCE patent protection has been sought for Bysanti TM , VTR-297 and CFTR activators and inhibitors.

Patent applications for these active ingredients remain pending.

Although the NCE patents protecting Fanapt ® and HETLIOZ ® have expired, Fanapt ® remains protected by additional patents and HETLIOZ ® and HETLIOZ LQ ® remain protected by additional patents, some of which we have asserted against current generic competitors.

Although NCE exclusivity and the NCE patents protecting Fanapt ® and HETLIOZ ® have expired, Fanapt ® remains protected by additional patents and HETLIOZ ® and HETLIOZ LQ ® also remain protected by additional patents, some of which we have asserted against current generic competitors.

For more on the license and sublicense arrangements related to these active ingredients, see License Agreements above.

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Product Number Type

US 8,586,610* Method of treatment

US 8,652,776 Method of treatment

US 8,999,638 Method of treatment

Method of treatment

US 8,652,776 Method of treatment

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US 9,549,913 Method of treatment

Method of treatment

US 9,855,241 Method of treatment

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US 10,071,977 Drug substance

US 10,149,829* Method of treatment

US 10,179,119 Method of treatment

US 10,149,829

Method of treatment

Product Number Type

US 10,179,119 Method of treatment

US 10,376,487

Method of treatment

US 10,449,176 Method of treatment

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US 10,829,465 Drug substance

Product Number Type

US 10,945,988 Method of treatment

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Drug substance

US 9,539,234 Method of treatment

US 12,201,604

Method of treatment

US 9,539,234 Method of treatment

US 10,071,977 Drug substance

Method of treatment

US 10,071,977*

Drug substance

US 10,149,829* Method of treatment

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Method of treatment

Product Number Type

US 11,918,556*

4 unchanged sentences

Drug substance

US 12,201,604

Method of treatment

US 12,447,141

Method of treatment

Drug substance

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Method of treatment

Product Number Type

New chemical entity

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Method of treatment

US 12,336,980

Method of treatment

US 10,772,880

Method of treatment

US 10,821,099

Method of treatment

US 11,324,735

Method of treatment

US 12,318,375

Method of treatment

The NCE patent for Fanapt ® , which expired in 2016 in the U.S.

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and listed in the Orange Book, with the latest expiration date in December 2031.

We have also filed and plan on filing additional patent applications covering the use of iloperidone (Fanapt ® active ingredient) LAI formulations.

We have also filed and plan on filing additional patent applications covering the use of Fanapt ® LAI formulations.

Patents for the microsphere LAI formulation of Fanapt ® expired in 2022 in some markets in Europe and expired in 2024 in the U.S.

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We have pending patent applications covering the use of iloperidone and plan on filing additional applications based on discoveries made throughout the development plan of this molecule.

We filed several Hatch-Waxman lawsuits in the Delaware District Court against a number of generic company competitors asserting infringement of two of our Fanapt ® patents.

The litigation has been resolved with respect to all but one of these competitors.

See Note 18, Legal Matters, to the consolidated financial statements in Part II, Item 8 of this Annual Report and the risk factor entitled “ We are, have been, and may continue to be, involved in lawsuits to protect or enforce our patents, which could be expensive, time-consuming and unsuccessful, and third parties may challenge the validity or enforceability of our patents and they may be successful ,” in Part I, Item 1A of this Annual Report, each of which is incorporated herein by reference, for additional information.

In Europe, the law provides for 10 years of regulatory exclusivity (with the potential for an additional year if the drug is developed for a significant new indication).

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HETLIOZ ® and HETLOZ LQ ®

Our rights to the NCE patent covering HETLIOZ ® capsules and oral suspension (HETLIOZ LQ ® ) and related intellectual property have been acquired through a license with BMS.

Our rights to the NCE patent covering HETLIOZ ® capsules and HETLIOZ LQ ® and related intellectual property have been acquired through a license with BMS.

HETLIOZ ® and its formulations, genetic markers and uses are the subject of numerous patent filings for which protection has been sought in selected countries worldwide.

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Additionally, the USPTO has issued a drug formulation patent for HETLIOZ LQ ® that will expire in 2040.

We also have other pending patent applications covering methods of treatment and compositions of tasimelteon (HETLIOZ ® active ingredient) oral suspensions.

We also have other pending patent applications covering methods of treatment and compositions of HETLIOZ LQ ® .

We filed several Hatch-Waxman lawsuits in the U.S.

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In January 2022, we entered into a license agreement with MSN and Impax Laboratories LLC resolving the lawsuits against MSN.

The consolidated lawsuits against Teva and Apotex were tried in March 2022.

consolidated lawsuits against Teva and Apotex were tried in March 2022.

In December 2022, the Delaware District Court ruled that Teva and Apotex did not infringe U.S.

RE46,604, and that the asserted claims of U.S.

and 10,376,487 were invalid.

We appealed the decision to the U.S.

Court of Appeals for the Federal Circuit (Federal Circuit) and in May 2023, a three-judge panel of the Federal Circuit affirmed the Delaware District Court’s ruling.

In August 2023, the Federal Circuit denied our request for a rehearing.

In January 2024, we filed a petition for a writ of certiorari with the U.S.

Supreme Court to review the Federal Circuit’s decision.

In April 2024, the U.S.

Supreme Court denied

our petition.

We have also filed Hatch-Waxman lawsuits in U.S.

District Court for the District of New Jersey against each of Teva and Apotex and in the U.S.

District Court for the Southern District of Florida against Apotex, in each case, asserting infringement of U.S.

and 10,376,487 were invalid, which was affirmed by the U.S.

Court of Appeals for the Federal Circuit (Federal Circuit) in May 2023.

Also in December 2022, we filed Hatch-Waxman lawsuits, which are currently pending in the Delaware District Court against each of Teva and Apotex, asserting infringement of U.S.

11,285,129, which is a method of administration patent that was not litigated in the prior litigation.

The New Jersey cases have been transferred to the Delaware District Court, where they remain pending, and the Florida case was voluntarily dismissed.

We have also filed patent infringement lawsuits against each of Teva and Apotex in the Delaware District Court, in each case, asserting infringement of U.S.

We also filed patent infringement lawsuits against each of Teva and Apotex in the Delaware District Court, in each case, asserting infringement of U.S.

11,918,556, another method of administration patent that was not litigated in the prior litigation.

A trial is scheduled to begin in these cases on August 3, 2026.

These lawsuits do not affect the sale of HETLIOZ ® in the E.U.

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with respect to HETLIOZ ® .

Furthermore, this litigation does not relate to the HETLIOZ LQ ® oral suspension formulation.

Furthermore, these lawsuits do not relate to the HETLIOZ LQ ® oral suspension formulation.

In July 2024, we filed a Hatch-Waxman lawsuit against MSN in the Delaware District Court asserting that the U.S.

10,179,119, 11,266,622, 11,285,129, 11,850,229, 10,610,510, 10,980,770, and 11,759,446 will be infringed by MSN’s generic version of HETLIOZ LQ ® for which MSN is seeking FDA approval.

Our lawsuit remains pending, and a trial is scheduled to begin on June 15, 2026.

In June 2025, we filed an amended complaint against MSN, further alleging that U.S.

10,071,977 and 11,566,011 will also be infringed by MSN’s generic version of HETLIOZ LQ ® .

Our lawsuit remains pending, and a trial is scheduled to begin on September 14, 2026.

In Europe, the law provides for 10 years of data exclusivity (with the potential for an additional year if a medicine is developed for a significant new indication).

In addition, Europe provides for 10 years of market exclusivity for orphan indications.

As such, in Europe, data or market exclusivity will provide protection for HETLIOZ ® for at least 10 years from approval.

It is also possible that the protection through a basic patent (i.e., a patent that protects a product as such, a process to obtain a product, or an application of a product) in Europe could be extended for up to five years by the issuance of a supplementary protection certificate (SPC).

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and Canadian derivative patents and patent applications arising from the foregoing patents and pending patent applications.

The NCE protecting PONVORY ® in the U.S.

The FDA-granted NCE exclusivity protecting PONVORY ® in the U.S.

will expire in March 2026.

The NCE patent covering the active ingredient in PONVORY ® (Reissue Patent No.

43,728) expired in November 2024, but an application for patent term extension (PTE) pursuant to the Hatch-Waxman Act was submitted to extend this patent’s term to November 2029.

The PTE application was granted on January 31, 2025.

43,728) is subject to a patent term extension pursuant to the Hatch-Waxman Act and expires in November 2029.

The USPTO has granted additional patents, including a further patent directed to a crystalline form of the active ingredient in PONVORY ® , which will expire in May 2032 as a result of the awarded patent term adjustment.

The USPTO has also issued four method of treatment patents for PONVORY ® , of which one expired in November 2024, and the remaining three will expire between December 2025 and October 2042.

PONVORY ® is also protected by three method of treatment patents which expire between December 2035 and October 2042.

Also, a number of patent applications covering further methods of treatment remain pending at the USPTO.

Because PONVORY ® was granted NCE exclusivity, no generic applications can be filed until one year prior to the expiration of that exclusivity, in March 2025.

In Canada, the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) create a regime analogous to the Hatch-Waxman Act and link the regulatory approval process for generic and biosimilar drugs to the adjudication of innovator patent rights.

To be eligible for protection under the PM(NOC) Regulations, patents must first be listed on the Patent Register in connection with an innovator’s drug submission to Health Canada.

A generic or biosimilar

manufacturer must then provide notice to the innovator of its plans to market a drug that it compared to the innovator’s patented drug in the Health Canada approval process.

A generic or biosimilar manufacturer must then provide notice to the innovator of its plans to market a drug that it compared to the innovator’s patented drug in the Health Canada approval process.

Within 45 days of receiving such a notice of allegation, an innovator drug company may commence patent infringement proceedings against the generic or biosimilar manufacturer.

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Health Canada’s Patent Register lists Canadian Patent Nos.

2740313 and 2968180 for PONVORY ® , which are respectively directed to the crystalline form of ponesimod, the active ingredient in PONVORY ® and methods of treatment.

2740313 and 2968180 for PONVORY ® , which are respectively directed to the crystalline form of PONVORY ® and methods of treatment.

These listed patents will respectively expire in October 2029 and, as a result of the CSP granted for 2968180, in April 2036.

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Canada has no distinct drug submission process for biosimilar or orphan drug products.

Lilly owns the NCE patent as well as patent applications directed to polymorphic forms of, and methods of making tradipitant.

Lilly owns the NCE patent as well as patent applications directed to polymorphic forms of, and methods of making NEREUS TM .

This patent protection was sought in the U.S.

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These patents and patent applications have been licensed to us.

The NCE patent covering tradipitant expired in April 2023, except in the U.S., where it expired in June 2024, subject to any extension that may be received under the Hatch-Waxman Act.

We have filed additional patent applications based on discoveries made during recent studies with tradipitant.

Anaptys owns patents and patent applications covering imsidolimab, an IL-36R antagonist, which have been licensed to us under an exclusive global license agreement.

The NCE patent covering NEREUS TM expired in April 2023, except in the U.S., where it expired in June 2024.

However, NEREUS TM is still subject to NCE exclusivity from the FDA under the Hatch-Waxman Act, which expires December 30, 2030.

We have filed additional patent applications based on discoveries made during recent studies with NEREUS TM , the latest of which expires in 2036.

Anaptys owns patents and patent applications covering imsidolimab, which have been licensed to us under an exclusive global license agreement.

These patents and applications include claims directed to antibodies that inhibit the interleukin-36 receptor, methods of use and formulations.

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and other countries.

In the U.S., the patent protection may be subject to extension under the Biologics Price Competition and Innovation Act (BPCIA), which provides a framework similar to the Hatch-Waxman Act for small molecules, allowing for potential exclusivity extensions for biologics.

In the U.S., the patent protection may be subject to extension under the Biologics Price Competition and Innovation Act, which provides a framework similar to the Hatch-Waxman Act for small molecules, allowing for potential exclusivity extensions for biologics.

The patents protecting imsidolimab are expected to provide exclusivity into the late 2030s.

We are committed to advancing the development of imsidolimab and may file additional patent applications based on discoveries made during its development.

For more on the license and sublicense arrangements related to imsidolimab, see License Agreements above.

VTR-297 is a small molecule HDAC inhibitor with potential use as a treatment for several oncology indications.

We have pending patent applications covering the use of VTR-297 and plan on filing additional applications based on discoveries made throughout the development plan of this molecule.

VTR-297 may be subject to further exclusivities from the FDA under the Hatch-Waxman Act.

Portfolio of CFTR activators and inhibitors

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Novartis owns the NCE patent as well as patent applications directed to methods of using VQW-765, VQW-765 formulations, and combinations of VQW-765 with other active pharmaceutical ingredients.

In connection with the settlement

agreement with Novartis relating to Fanapt ® , we received an exclusive worldwide license under certain patents and patent applications, and other licenses to intellectual property, to develop and commercialize VQW-765, a Phase II alpha-7 nicotinic acetylcholine receptor partial agonist.

The NCE patent expired normally in 2023 in the U.S., Europe and other markets.

VQW-765 may be subject to further exclusivities from the FDA under the Hatch-Waxman Act.

Other patents

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In addition, we have filed numerous other patent applications relating to drugs not presently in clinical studies.

The claims in these various patents and patent applications are directed to compositions of matter, including claims covering other products, pharmaceutical compositions and methods of use.

claims in these various patents and patent applications are directed to compositions of matter, including claims covering other products, pharmaceutical compositions and methods of use.

Proprietary know-how

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for the treatment of Non-24 in totally blind adults in July 2015 and, in August 2016, we commercially launched HETLIOZ ® in Germany.

Given the range of potential indications for HETLIOZ ® , we may pursue one or more partnerships for the development and commercialization of HETLIOZ ® worldwide.

We continue to explore the regulatory path and commercial opportunity for HETLIOZ ® in other regions.

PONVORY ® tablets were approved in the U.S.

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by Janssen in April 2021.

PONVORY ® tablets were approved in Canada for the treatment of RMS in adults in April 2021 and commercially launched in Canada by Janssen in November 2021.

PONVORY ® tablets were approved in Canada for the treatment of RMS in adults in April 2021.

We acquired the U.S.

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operations of PONVORY ® during 2024.

NEREUS TM capsules were approved in the U.S.

for the preventing of vomiting induced by motion in December 2025.

Major Customers

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These developments may render our products or technologies obsolete or noncompetitive.

We believe the competitors for Fanapt ® , HETLIOZ ® and PONVORY ® are as follows:

• For Fanapt ® in the treatment of schizophrenia, the atypical antipsychotics competitors are Risperdal ® (risperidone), including the LAI formulation Risperdal Consta ® , and Invega ® Sustenna ® (paliperidone), each by Johnson & Johnson, the LAI formulation Zyprexa ® Relprevv TM (olanzapine) by Cheplapharm, Abilify ® (aripiprazole) by Otsuka America Pharmaceutical Inc., Abilify Maintena ® (the LAI formulation of Abilify ® ), Abilify Asimtufi ® and Rexulti ® (brexpiprazole), all by Lundbeck/Otsuka America Pharmaceutical Inc., Geodon ® (ziprasidone) by Viatris, Inc., Saphris ® (asenapine) and Vraylar ® (cariprazine), both by AbbVie Inc., Latuda ® (lurasidone) by Sunovion Pharmaceuticals Inc., Aristada ® (aripiprazole lauroxil) extended-release injectable suspension and Lybalvi ® (olanzapine and samidorphan), both by Alkermes, plc, Caplyta ® (lumapteperone) by Intra-Cellular Therapies, Inc., Cobenfy TM (xanomeline/trospium chloride) by BMS, Secuado ® (asenapine) by Noven Pharmaceuticals and generic clozapine and quetiapine, as well as the typical antipsychotics haloperidol, chlorpromazine, thioridazine, and sulpiride (all of which are generic).

For Fanapt ® in the treatment of bipolar I disorder, competitors include Lithobid ® (lithium) by ANI Pharmaceuticals, Depakote ® (divalproex sodium) and Vraylar ® (cariprazine), both by AbbVie Inc., Lamictal ® (lamotrigine by GlaxoSmithKline, Seroquel ® (quetiapine fumarate) by AstraZeneca, Risperdal ® (risperidone), including the LAI formulation Risperdal Consta ® , by Johnson & Johnson, Abilify ® (aripiprazole) by Otsuka America Pharmaceutical Inc., Abilify Maintena ® (the LAI formulation of Abilify ® ) and Abilify Asimtufi ® , both by Lundbeck/Otsuka America Pharmaceutical Inc., Latuda ® (lurasidone) by Sunovion Pharmaceuticals Inc., Zyprexa ® (olanzapine) and Symbyax ® (olanzapine/fluoxetine), both by Lilly, Caplyta ® (lumapteperone) by Intra-Cellular Therapies, Inc., Lybalvi ® (olanzapine and samidorphan) by Alkermes, plc, Geodon ® (ziprasidone) by Viatris, Inc.

and Equetro ® (carbamazepine) by Validus Pharmaceuticals LLC.

We believe the competitors for our commercial products are as follows:

• For Fanapt ® in the treatment of schizophrenia and bipolar, competitors include drugs in the atypical and typical antipsychotics classes .

• For HETLIOZ ® in the treatment of nighttime sleep disturbances in SMS, there are no FDA approved direct competitors.

For HETLIOZ ® in the treatment of Non-24, Teva and Apotex have launched their respective Abbreviated New Drug Application (ANDA) products at risk, and the FDA has also approved the ANDA for MSN.

In addition, sedative-hypnotic treatments for certain sleep-related disorders include, Ambien ® (zolpidem), including Ambien CR ® , by Cosette Pharmaceuticals, Inc., Lunesta ® (eszopiclone) by Woodward Pharma Services LLC, Rozerem ® (ramelteon) by Takeda Pharmaceuticals Company Limited, Silenor ® (doxepin) by Currax Pharmaceuticals LLC, Belsomra ® (suvorexant) by Merck & Co., Inc., Dayvigo ® (lemborexant) by Eisai Inc., generic products such as agomelatine, zaleplon, trazodone and doxepin, and over-the-counter remedies such as Benadryl ® and Tylenol PM ® .

The class of melatonin agonist treatments includes Rozerem ® (ramelteon) by Takeda Pharmaceuticals Company Limited, and the food supplement melatonin.

Shift work and excessive sleepiness disorder treatments include Nuvigil ® (armodafinil) and Provigil ® (modafinil) both by Apotex.

• For PONVORY ® in the treatment of RMS, the competitors include Avonex ® (interferon beta-1a), Tysabri ® (natalizumab), Tecfidera ® (Dimethyl fumarate) and Plegridy ® (peginterferon beta-1a), all by Biogen Inc., Vumerity ® (diroximel fumerate) by Biogen Inc./Alkermes, plc, Betaseron ® (interferon beta-1b) by Bayer Healthcare Pharmaceuticals Inc., Rebif ® (interferon beta-1a) and Mavenclad ® (cladribine), both by Merck KGaA, Extavia ® (interferon beta-1b), Mayzent ® (siponimod), Gilenya ® (fingolimod) and Kesimpta ® (ofatumumab), all by Novartis AG, Lemtrada ® (alemtuzumab) and Aubagio ® (teriflunomide), both by Sanofi, Ocrevus ® (ocrelizumab) by Roche Holding AG/Biogen Inc., Zeposia ® (ozanimod) by BMS, Briumvi ® (ubiltuximab) by TG Therapeutics, Inc., Tyruko ® (natalizumab) by Sandoz Group AG and Copaxone ® (glatiramer acetate) by Teva.

In addition to those direct competitors, drugs that indirectly compete with HETLIOZ ® include sedative-

hypnotic treatments for certain sleep related disorders, over-the-counter remedies such as Benadryl ® and Tylenol PM ® , melatonin agonists, and shift work and excessive sleepiness disorder treatments.

• For PONVORY ® in the treatment of RMS, the competitors include drugs in the sphingosine 1-phosphate (S1P) receptor modulator class and other immune-modulating or immunosuppressive therapies for MS.

• For NEREUS TM in the prevention of vomiting induced by motion, the competitors include drugs in the neurokinin-1 (NK-1) class, antiemetics, scopalamine and other drugs approved for the prevention and treatment of motion sickness.

Our ability to compete successfully will depend, in part, on our ability to utilize our pharmacogenetics and pharmacogenomics and drug development expertise to identify, develop, secure rights to and obtain regulatory approvals for promising pharmaceutical products before others are able to develop competitive products.

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We expect to continue to rely solely on third-party manufacturers to manufacture drug substance and final drug products for both clinical development and commercial sale.

However, there are numerous factors that could cause interruptions in the supply of our products, including regulatory reviews, changes in our sources for manufacturing, disputes with a

manufacturer, or financial instability of manufacturers, all of which could negatively impact our operations and our financial results.

However, there are numerous factors that could cause interruptions in the supply of our products, including regulatory reviews, changes in our sources for manufacturing, disputes with a manufacturer, or financial instability of manufacturers, all of which could negatively impact our operations and our financial results.

We have agreements in place with Patheon Pharmaceuticals Inc.

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The HETLIOZ LQ ® manufacturing agreement has an initial term of five years and automatically renews after the initial term for successive terms of one year each, unless either party gives notice of its intention to terminate the agreement at least 12 months prior to the end of the then current term.

In December 2024, we entered into a non-exclusive manufacturing agreement of PONVORY ® .

In December 2024, we entered into a non-exclusive manufacturing agreement for the manufacture of commercial supplies of PONVORY ® .

The PONVORY ® manufacturing agreement has an initial term of three years and automatically renews after the initial term until the termination or expiration of any outstanding project agreements.

In December 2025, we entered into a non-exclusive product agreement for the manufacture of commercial supplies of NEREUS TM drug product.

The NEREUS TM product agreement has an initial term of five years and automatically renews after the initial term for additional three year periods.

After the initial term, either party may terminate the agreement by giving 36 months’ written notice.

Government Regulation

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at the federal, state and local levels and in other countries extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, recordkeeping, promotion, advertising, distribution, marketing and export and import of pharmaceutical products.

A new drug must be approved by the FDA through the NDA process before it may be legally marketed in the U.S.

A new product must be approved by the FDA through the NDA process (for a drug) or the BLA process (for a biologic product) before it may be legally marketed in the U.S.

The process of obtaining regulatory approvals and the subsequent compliance with applicable federal, state, local and foreign laws and regulations require the expenditure of substantial time and financial resources.

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requirements at any time during the product development process, approval process or post-approval may subject an applicant to administrative or judicial sanctions.

These sanctions could include the FDA’s refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning

letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement and/or civil or criminal penalties.

These sanctions could include the FDA’s refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement and/or civil or criminal penalties.

Any agency or judicial enforcement action could have a material adverse effect on our business.

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The FDA must send a non-compliance letter to any sponsor that fails to submit the required assessment, keep a deferral current or fails to submit a request for approval of a pediatric formulation.

If a pediatric assessment or a request for approval of a pediatric formulation is not submitted by a sponsor in accordance with the statutory requirements, the drug may be considered misbranded because of that failure and subject to relevant enforcement actions.

If a drug receives FDA approval, the approval may be limited to specific diseases and dosages, which could restrict the commercial value of the product.

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The FDA will not approve the NDA without an approved REMS, if required.

A REMS could include medication guides, physician communication plans or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools.

A REMS could include medication guides, physician communication plans or

elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools.

Any of these limitations on approval or marketing could restrict the commercial promotion, distribution, prescribing or dispensing of products.

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Failure to comply with the applicable governmental requirements at any time during the product development process, approval process or after approval, may subject an applicant or manufacturer to administrative or judicial civil or criminal sanctions and adverse publicity.

production or distribution, injunctions, fines, refusals of government contracts, mandated corrective advertising or communications with doctors, debarment, restitution, disgorgement of profits, or civil or criminal penalties, any of which could have a material adverse effect on our business.

FDA sanctions could include refusal to approve pending applications, withdrawal of an approval, clinical holds on post-marketing clinical trials, enforcement letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, mandated corrective advertising or communications with doctors, debarment, restitution, disgorgement of profits, or civil or criminal penalties, any of which could have a material adverse effect on our business.

Orphan drug designation

Under the Orphan Drug Act, the FDA may grant orphan drug designation to drugs intended to treat a rare disease or condition, generally a disease or condition that affects fewer than 200,000 individuals in the U.S or, if it affects more than 200,000 individuals in the U.S., there is no reasonable expectation that sales of the drug will be sufficient to offset the cost of developing and making the drug available in the U.S.

or, if it affects more than 200,000 individuals in the U.S., there is no reasonable expectation that sales of the drug will be sufficient to offset the cost of developing and making the drug available in the U.S.

Orphan drug designation must be requested before submitting an NDA.

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Specifically, new drugs are eligible for fast track designation if they are intended to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition.

With regard to a fast track product, the FDA may consider for review sections of the NDA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the NDA, the FDA agrees to accept sections of the NDA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the NDA.

NDA, the FDA agrees to accept sections of the NDA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the NDA.

Any product submitted to the FDA for approval, including a product with a fast track designation, may also be eligible for other types of FDA programs intended to expedite development and review, such as priority review and accelerated approval.

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As a condition of approval, the FDA may require that a sponsor of a drug receiving accelerated approval perform adequate and well-controlled post-marketing clinical trials.

If the FDA requires such post-marketing studies, it will specify the conditions for such studies, which may include enrollment targets, the study protocol and milestones, including the target date of study completion.

The FDA may also require that a study or studies be underway prior to approval, or within a specified time period after the date of approval.

Drugs receiving accelerated approval may be subject to expedited withdrawal procedures if the sponsor fails to conduct the required post-marketing trials or if such trials fail to verify the predicted clinical benefit.

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The designation includes all of the fast track program features, as well as more intensive FDA interaction and guidance.

The breakthrough therapy designation is a distinct status from

both accelerated approval and priority review, which can also be granted to the same drug if relevant criteria are met.

The breakthrough therapy designation is a distinct status from both accelerated approval and priority review, which can also be granted to the same drug if relevant criteria are met.

If a product is designated as a breakthrough therapy, the FDA will work to expedite the development and review of such drug.

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Three-year exclusivity is available to the holder of an NDA, including a 505(b)(2) NDA, for a particular condition of approval or change to a marketed product, such as a new formulation, route of administration or indication for a previously approved product, if one or more new clinical trials, other than bioavailability or bioequivalence trials, was essential to the approval of the application and was conducted or sponsored by the applicant.

This three-year exclusivity period protects against FDA approval of ANDAs and 505(b)(2) NDAs for the condition of the new drug’s approval.

This three-year

exclusivity period protects against FDA approval of ANDAs and 505(b)(2) NDAs for the condition of the new drug’s approval.

As a general matter, three-year exclusivity granted for a new drug does not prohibit the FDA from approving additional ANDAs or 505(b)(2) NDAs for generic versions of the original, unmodified drug product.

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False Claims Act

The federal False Claims Act prohibits, among other things, knowingly presenting, or causing to be presented false or fraudulent claims for payment of government funds and knowingly making, or causing to be made or used, a false record or

statement to get a false claim paid.

Certain marketing practices may implicate the False Claims Act, including promotion of pharmaceutical products for unapproved uses, providing free product to customers with the expectation that customers would bill federal programs for the product, or inflating prices reported to private price publication services used to set drug reimbursement rates under federal healthcare programs.

Under the False Claims Act, “knowing” is defined the include actual knowledge, deliberate ignorance or reckless disregard.

In addition, the ACA amended the Social Security Act to provide that a claim including items or services resulting from a violation of the Anti-Kickback Statute constitutes a false claim for purposes of the False Claims Act.

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Foreign Corrupt Practices Act

The Foreign Corrupt Practices Act (FCPA), prohibits U.S.

corporations and their representatives and intermediaries from offering, promising, authorizing or making payments to any foreign government official, government staff member, political party or political candidate in an attempt to obtain or retain business abroad.

Foreign Corrupt Practices Act (FCPA), prohibits U.S.

corporations and their representatives and intermediaries from offering, promising, authorizing or giving anything of value to any foreign government official, government staff member, political party or political candidate in an attempt to obtain or retain business abroad or otherwise secure an improper business advantage.

The scope of the FCPA includes interactions with certain healthcare professionals in many countries.

Violation of the FCPA could result in substantial civil and criminal penalties and remedies, including fines, disgorgement, debarment and/or imprisonment.

Other jurisdictions in which we operate or supply products have similar anti-corruption laws and/or regulations.

Analogous state laws

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In addition to requiring reporting transfers of value, some states have imposed price reporting requirements.

These state laws apply to items

and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor.

These state laws apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor.

In addition, a number of states require pharmaceutical companies to report expenses relating to the marketing and promotion of pharmaceutical products and to report gifts and payments to individual physicians in the states.

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For example, the California Consumer Privacy Act (CCPA), which became effective on January 1, 2020, as further amended by the California Privacy Rights Act, along with corresponding regulations, established a new legal framework governing covered businesses’ collection and use of personal information of California residents by, among other things, creating an expanded definition of covered personal information, establishing new privacy rights for California residents, imposing an opt-in standard for certain disclosures of personal information about minors, and creating a new and potentially severe statutory damages framework for businesses subject to certain data breaches resulting from the failure to implement and maintain reasonable security procedures and practices.

While properly collected clinical trial data and all protected health information governed by HIPAA are exempt from the current version of the CCPA, other personal information may be applicable and possible changes to the CCPA may broaden its scope.

While some exceptions apply, such as personal information collected as part of a clinical trial subject to the Federal Policy for the Protection of Human Subjects and protected health information governed by HIPAA are exempt from the current version of the CCPA, other personal information is in scope.

In addition to California, there are over twenty other states with comprehensive consumer or consumer health privacy laws.

Every state maintains a data breach notification law.

Foreign regulation

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drug development and regulation .

However, the foreign equivalent of an IND is not a prerequisite to performing pilot studies or Phase I clinical trials.

However, the foreign equivalent of an IND is not a prerequisite to performing pilot studies.

regulatory systems, a sponsor may submit Marketing Authorization Applications either under a centralized or decentralized procedure.

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Member States.

The centralized procedure is compulsory for some drugs and optional for others.

This authorization is referred to as a marketing authorization approval.

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individuals, or monitoring their behavior within the E.U., regardless of the controller’s or processor’s location.

The GDPR implements stringent operational requirements for controllers and processors of personal data, including, for example, the implementation of transparent information for data subjects regarding the processing of their personal data, appropriate legal basis for the processing of personal data, which may include the obtaining of valid consent in certain circumstances, expanded individual data subject rights, limitations on retention of personal data, increased requirements pertaining to data security and confidentiality, mandatory data breach notification to the competent supervisory authority and higher standards for controllers and processors to demonstrate their compliance with

the GDPR through appropriate documentation.

The GDPR provides that E.U.

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Member States, limit a company’s ability to collect, use and share such personal data or cause their costs to increase, and harm their reputation, business and financial condition.

Further, the U.K.’s exit from the E.U., often referred to as Brexit, has created uncertainty with regard to applicable data protection regulation in the U.K.

While the transition period has now concluded, decisions are still to be made on how to adapt the U.K.

data protection provisions further to Brexit.

Companies are also subject to evolving and strict rules on the transfer of personal data out of the E.U., in particular to the U.S.

Failure to comply with the GDPR may result in fines of up to the higher of €20,000,000 or 4% of total worldwide annual revenue of the preceding financial year, and other administrative penalties.

The GDPR has been implemented in the United Kingdom (U.K.) in the form of the U.K.

General Data Protection Regulation (U.K.

GDPR), as supplemented by the U.K.

Data Protection Act 2018 and amended by the Data Use and Access Act 2025.

GDPR adapts the GDPR for the U.K.

context, and, while recent amendments have created some divergence from the GDPR, the considerations set out above in respect of the GDPR also apply in respect of the U.K.

Pharmaceutical Coverage, Pricing and Reimbursement and Healthcare Reform

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such as Medicare and Medicaid, commercial health insurers and managed care organizations.

The process for determining whether a payor will provide coverage for a product may be separate from the process for setting the price or reimbursement rate that the payor will pay for the product once coverage is approved.

Third-party payors are increasingly challenging the prices charged, examining the medical necessity, and reviewing the cost-effectiveness of medical products and services and imposing controls to manage costs.

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• expanded the types of entities eligible for the 340B drug discount program;

• established the Medicare Part D coverage gap discount program by requiring manufacturers to provide a point‑of‑sale‑discount off the negotiated price of applicable brand drugs to eligible beneficiaries during their coverage gap period as a condition for the manufacturers’ outpatient drugs to be covered under Medicare Part D;

• established a new Patient‑Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;

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Since its enactment, there have been judicial, executive and Congressional challenges to certain aspects of the ACA.

In June 2021, the U.S.

Supreme Court dismissed the most recent judicial challenge to the ACA brought by several states without specifically ruling on the constitutionality of the ACA.

For example, in June 2021, the U.S.

Supreme Court dismissed a judicial challenge to the ACA brought by several states without specifically ruling on the constitutionality of the ACA.

Other legislative changes have been proposed and adopted since the ACA was enacted.

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These new definitions became effective on January 1, 2022.

In September 2024, CMS issued a final rule that implemented regulations to, among other things, reflect the removal of the rebate cap in accordance with the American Rescue Plan Act of 2021.

In September 2024, CMS issued a final rule that

implemented regulations to, among other things, reflect the removal of the rebate cap in accordance with the American Rescue Plan Act of 2021.

Most significantly, in August 2022, President Biden signed the Inflation Reduction Act of 2022 (IRA) into law.

This statute marks the most significant action by Congress with respect to the pharmaceutical industry since adoption of the ACA in 2010.

Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare, with prices that can be negotiated subject to a cap, with the first drug price negotiations effective January 1, 2026;

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The IRA permits the Secretary of the Department of Health and Human Services (HHS) to implement many of these provisions through guidance, as opposed to regulation, for the initial years.

On March 15, 2023 and June 30, 2023, HHS issued guidance regarding implementation of the Medicare drug price negotiation program in initial price applicability year 2026.

More recently, in October 2024, HHS released guidance related to implementation for initial price applicability year 2027.

In August 2024, CMS announced prices for the first ten drugs under the drug price negotiation program, with the new prices going into effect in 2026, and is expected to announce the next fifteen drugs to be selected for the second round of negotiations by February 1, 2025.

HHS has continued to issue guidance as these programs are implemented.

In August 2024, CMS announced prices for the first ten drugs under the drug price negotiation program, with the negotiated prices going into effect in 2026, and, in March 2025, announced the next fifteen drugs for the second round of negotiations, with negotiated prices going into effect in 2027.

Several manufacturers and industry groups have challenged the drug price negotiation program for Medicare Parts B and D in federal court.

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It is unknown whether such litigation or other litigation, if brought, will be successful, or whether there will be future changes to the IRA.

Moreover, the recent change in presidential administrations in the U.S.

may introduce additional unpredictability regarding the future of the IRA.

Moreover, the change in presidential administration in 2025 and associated executive branch policy priorities have introduced additional unpredictability regarding the future implementation of the IRA.

For these and other reasons, it is currently unclear how the IRA will be effectuated, and while the impact of the IRA on the pharmaceutical industry cannot yet be fully determined, it is likely to be significant.

The One Big Beautiful Bill Act (OBBBA), signed into law in the U.S.

in July 2025, imposes significant reductions in Medicaid funding, which is expected to decrease the number of Medicaid beneficiaries and services covered.

The cost of prescription pharmaceuticals in the U.S.

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There have been several Congressional inquiries and proposed and enacted legislation designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, reduce the costs of drugs under Medicare, and reform government program reimbursement methodologies for drug products.

Additionally, the Trump administration is pursuing various strategies to reduce drug costs and otherwise pursuing policies that could negatively impact the pharmaceutical industry.

The likelihood of implementation of these and other reform initiatives is uncertain.

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We expect that healthcare reform measures that may be adopted in the future may result in more rigorous coverage criteria, new payment methodologies and additional downward pressure on the price that we receive for any approved product.

Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors.

The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or commercialize our product candidates.

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provides options for its Member States to restrict the range of drug products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use.

Member States may approve a specific price for a drug product or may instead adopt a system of direct or indirect controls on the profitability of the company placing the drug product on the market.

Member States may

approve a specific price for a drug product or may instead adopt a system of direct or indirect controls on the profitability of the company placing the drug product on the market.

Other Member States allow companies to fix their own prices for drug products but monitor and control company profits.

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To access these documents from the main page of our website, click on “Investors” at the top of the page, then click on “Learn More” under “Corporate Governance” and then click on the desired document.

to satisfy the disclosure requirements under Item 5.05 of Form 8‑K regarding amendments to, or waivers from, provisions of our code of business conduct and ethics by posting such information on the website address and location specified above.

We intend to satisfy the disclosure requirements under Item 5.05 of Form 8‑K regarding amendments to, or waivers from, provisions of our code of business conduct and ethics by posting such information on the website address and location specified above.

None of the information contained on our website or www.sec.gov is incorporated by reference into this Annual Report or any other report or document filed with the SEC unless expressly stated otherwise therein.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business