What changed in this filing

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Item 1. Business

2025-02-25 compared with 2024-02-27 · 326 added, 329 removed, 1086 unchanged (38% of the section changed)

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(the Company) is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.

Our diverse neuroscience portfolio includes approved treatments for epilepsy, migraine, attention-deficit hyperactivity disorder (ADHD), hypomobility in Parkinson’s Disease (PD), cervical dystonia, chronic sialorrhea, dyskinesia in PD patients receiving levodopa-based therapy, and drug-induced extrapyramidal reactions in adult patients.

The Company is developing a broad range of novel CNS product candidates including new potential treatments for hypomobility in PD, epilepsy, depression, and other CNS disorders.

The Company's diverse neuroscience portfolio includes approved treatments for attention-deficit hyperactivity disorder (ADHD), dyskinesia in Parkinson's Disease (PD) patients receiving levodopa-based therapy, hypomobility in PD, epilepsy, migraine, cervical dystonia, and chronic sialorrhea.

The Company is developing a broad range of novel CNS product candidates including new potential treatments for epilepsy, depression, and other CNS disorders.

The Company was incorporated in Delaware, commenced operations in 2005, became publicly traded in 2012, and is listed on the NASDAQ Stock Exchange under the ticker symbol SUPN.

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• Drive growth and profitability.

Using dedicated sales and marketing resources in the U.S., we will continue to drive the revenue growth of our marketed products.

Using dedicated sales and marketing resources in the U.S., we continue to drive the revenue growth of our key marketed products.

• Advance product candidates toward commercialization.

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• Continue to grow our pipeline.

We will continue to evaluate and develop additional CNS product candidates that we believe have significant commercial potential through our internal research and development efforts.

We continue to evaluate and develop additional CNS product candidates that we believe have significant commercial potential through our internal research and development efforts.

• Target strategic business development opportunities.

We are actively exploring a broad range of strategic opportunities.

This includes in-licensing products and entering into co-promotion and co-development partnerships for our commercial products and product candidates.

We actively explore a broad range of strategic opportunities.

This includes in-licensing products and entering into co-promotion and co-development partnerships for our commercial products and product candidates, as well as acquisitions of businesses with either or both commercial products and product candidates.

Commercial Products

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The Company launched Qelbree for adult patients in May 2022.

In January 2025, the FDA approved an expanded label update for Qelbree to include new data on the pharmacodynamics and use in breastfeeding mothers.

GOCOVRI (amantadine) extended-release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with PD receiving levodopa-based therapy, with or without concomitant dopaminergic medications, and as an adjunctive treatment to levodopa/carbidopa in patients with PD experiencing "OFF" episodes.

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The February 2021 update to the label indication makes GOCOVRI the only medicine clinically proven and approved to reduce both "OFF" episodes and dyskinesia in PD patients taking a levodopa-based medication, resulting in a clinically meaningful increase in good "on" time without the need for a "trade-off' when managing these motor complications.

GOCOVRI has been granted orphan drug exclusivity until August 24, 2024 for the treatment of dyskinesia in patients with PD receiving levodopa-based therapy with or without concomitant dopaminergic medications.

Oxtellar XR ®

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In January 2019, we launched Oxtellar XR for monotherapy treatment of partial onset epilepsy seizures in adults and children 6 to 17 years of age.

The Company has entered into settlement and license agreements with third parties permitting the sale of a generic version of Oxtellar XR beginning in September 2024, or sooner under certain conditions, and entitling the Company to receive royalties on those sales.

For more information, refer to Part I, Item I—Business — Intellectual Property and Exclusivity in this annual Report on Form 10-K.

APOKYN (apomorphine hydrochloride injection) is a product indicated for the acute, intermittent treatment of hypomobility or "OFF" episodes ("end-of-dose wearing off" and unpredictable "on-off" episodes) in patients with advanced PD.

APOKYN's adjustable dose subcutaneous injection pen is designed to quickly and reliably reverse the effects of oral levodopa wearing off in patients with inadequately controlled PD.

Trokendi XR ®

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Trokendi XR is the first once-daily extended-release topiramate product indicated for the treatment of epilepsy and the prophylaxis of migraine headaches in adults and adolescents in the U.S.

The Company entered into settlement agreements with third parties permitting the sale of a generic version of Trokendi XR beginning in January 2023 and entitling the Company to receive royalties on those sales.

For more information, refer to Part I, Item I—Business — Intellectual Property and Exclusivity in this annual Report on Form 10-K.

APOKYN (apomorphine hydrochloride injection) is a product indicated for the acute, intermittent treatment of hypomobility or "off" episodes ("end-of-dose wearing off" and unpredictable "on-off" episodes) in patients with advanced PD.

APOKYN's adjustable dose subcutaneous injection pen is designed to quickly and reliably reverse the effects of oral levodopa wearing off in patients with inadequately controlled PD.

XADAGO (safinamide) is a once-daily product indicated as adjunctive treatment to levodopa/carbidopa in patients with PD who are experiencing "OFF" episodes.

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MYOBLOC was approved by the FDA in August 2019 for the treatment of chronic sialorrhea in adults and in December 2000 for the treatment of adults with cervical dystonia.

Osmolex ER (amantadine) extended-release tablets is for the treatment of PD and drug-induced extrapyramidal reactions in adult patients.

Osmolex ER was approved by the FDA in February 2018.

In December 2023, the Company submitted to the FDA a notification of discontinuance to withdraw Osmolex ER from distribution, stating that manufacturing has been discontinued and distribution of the product will cease by April 1, 2024.

ONAPGO (apomorphine hydrochloride) injection is the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced PD.

ONAPGO was approved by the FDA in February 2025 and received an Orphan Drug Designation.

ONAPGO will be launched in the second quarter of 2025.

Research and Development

We are committed to the development of innovative product candidates in neurology and psychiatry, including the following:

We also engage in a variety of additional research and development efforts including development of a pipeline of novel CNS product candidates for the treatment of various CNS conditions.

We also engage in a variety of research and development efforts including development of a pipeline of novel CNS product candidates for the treatment of various CNS conditions.

We have devoted and continue to devote significant resources to research and development activities.

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and expanding product indications for approved products and our intellectual property portfolio.

Our expectations regarding our research and development programs are subject to the risks described under Item 1A—Risk Factors—Risks Related to Our Industry and Business , which includes the risk that the Company's financial condition and results of operations for fiscal year 2023 and beyond may be materially and adversely affected by delays and failures in the completion of clinical development of our product candidates, which could increase our costs or delay or limit our ability to generate revenues.

SPN-830 (apomorphine infusion device)

SPN-830 is a late-stage drug/device combination product candidate for the continuous treatment of motor fluctuations ("off" episodes) in PD patients that are not adequately controlled with oral levodopa and one or more adjunct PD medications.

If approved, it would be the only continuous infusion of apomorphine available in the U.S.

and an important step for PD patients that would have otherwise been candidates for potentially invasive surgical procedures, such as deep brain stimulation.

Continuous slow infusion may also limit some of the side effects of a bolus injection of apomorphine.

In December 2021, we resubmitted the NDA to the FDA.

In February 2022, we received a notice from the FDA that the resubmission of the NDA for SPN-830 was considered as a Standard Review and was assigned a PDUFA target action date in early October 2022.

In October 2022, the FDA issued a Complete Response Letter (CRL) regarding the NDA for SPN-830.

In February 2023, the FDA granted the Company a Type C meeting request to discuss the CRL with the meeting scheduled in April 2023.

In October 2023, we resubmitted the NDA for SPN-830.

In November 2023, the FDA accepted the resubmission of the NDA for SPN-830.

The resubmission is now considered filed, with a user fee goal date (PDUFA date) of April 5, 2024.

SPN-820 (NV-5138)

SPN-820 is a first-in-class, orally active small molecule that activates the brain mechanistic target of rapamycin complex 1 (mTORC1), a gatekeeper of cellular metabolism and renewal.

SPN-820 binds to and modulates sestrin, which senses amino acid availability in the brain, a potent natural activator of mTORC1.

The mTORC1 activity governs the pace and ability of the cell to synthesize protein and other cellular components.

This complex may be suppressed in people suffering from depression.

In other disease states such as severe depression, inadequate mTORC1 activity contributes to disease pathology by limiting energy utilization and protein synthesis, leading to impaired function.

Multiple preclinical studies have shown that mTORC1 activation is required for the efficacy of many rapid-acting antidepressant compounds, including but not limited to modulators of the N-methyl-D-aspartic-acid (NMDA)-mediated signaling

pathway like ketamine.

A Phase I trial demonstrated early proof of concept in which a single dose of SPN-820 showed a rapid and sustained improvement in core symptoms, with favorable safety and tolerability in patients with treatment resistant depression.

We believe the novel mechanism of action (MOA) in depression may improve symptoms of depression in patients who have failed other agents.

An Investigational New Drug (IND) application was submitted to the FDA in September 2021.

We initiated a Phase II multi-center, randomized double-blind placebo-controlled parallel design study of SPN-820 in adults with treatment resistant depression.

The study will examine the efficacy and safety of SPN-820 over a course of five weeks of treatment in approximately 270 patients.

The primary outcome measure is the change from baseline to end of treatment period on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score, a standard depression rating scale.

Additionally, we initiated a Phase II multi-center open label study in 40 subjects with Major Depressive Disorder (MDD) in the fourth quarter of 2023.

The study will evaluate the efficacy of SPN-820 in MDD, with the change from baseline in the Hamilton Depression Rating scale-6 (HAM-D6) total score as the primary efficacy assessment.

Our expectations regarding our research and development programs are subject to the risks described under Item 1A—Risk Factors—Risks Related to Our Industry and Business .

ONAPGO (formerly SPN-830)

ONAPGO (apomorphine hydrochloride) injection is the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced PD.

ONAPGO was approved by the FDA in February 2025 and received an Orphan Drug Designation.

ONAPGO will be launched in the second quarter of 2025.

The approval of ONAPGO is based on results from a Phase 3, twelve-week, multicenter, parallel-group, double-blind, randomized, placebo-controlled study (N=107) evaluating the efficacy and safety of ONAPGO.

The primary efficacy endpoint was the mean change in total daily "OFF" time assessed from baseline to the end of the twelve-week treatment period based on patient diaries.

The key secondary endpoints were the mean change in daily GOOD ON time, which was defined as ON time without troublesome dyskinesia, and Patient Global Impression of Change (PGIC).

During the Phase 3 study, ONAPGO significantly reduced the amount of daily "OFF" time at twelve weeks from baseline (p=0.0114), with ONAPGO-treated patients (n=53) experiencing a 2.6-hour reduction compared to placebo (n=51) with 0.9 hours.

The reduction in daily "OFF" time was accompanied by a similar significant increase in daily GOOD ON time (2.8 hours for ONAPGO-treated patients compared to 1.1 hours for the placebo group;

In addition, numerically greater improvements in daily "OFF" time and daily GOOD ON time were seen as early as the first week of treatment and were maintained throughout all measured timepoints.

Additionally, ONAPGO-treated patients more frequently reported improvement in their state of general health compared with placebo-treated patients (PGIC:

The most common adverse events (≥10% incidence) were infusion-site nodule, nausea, somnolence, infusion-site erythema, dyskinesia, headache, and insomnia.

SPN-817 (huperzine A)

SPN-817 represents a novel MOA for an anticonvulsant.

SPN-817 is a novel synthetic form of

huperzine A, whose MOA includes potent acetylcholinesterase inhibition, with pharmacological activities in CNS conditions such as epilepsy.

The development will initially focus on the drug's anticonvulsant activity, which has been shown in preclinical models to be effective for the treatment of partial seizures and Dravet Syndrome.

SPN-817 is a novel synthetic form of huperzine A, whose MOA includes potent acetylcholinesterase inhibition, with pharmacological activities in CNS conditions such as epilepsy.

The development will initially focus on the drug's anticonvulsant activity, which has been shown in preclinical models to be effective

for the treatment of partial seizures and Dravet Syndrome.

SPN-817 has received Orphan Drug Designation for both Dravet Syndrome and Lennox-Gastaut Syndrome from the FDA.

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Given the potency of SPN-817 (huperzine A), a novel extended-release oral dosage form is critical to the success of this program because initial studies with the immediate-release formulations of non-synthetic SPN-817 (huperzine A) have shown serious dose-limiting, side effects.

We have commenced an open-label Phase IIa clinical study of SPN-817 in patients with treatment-resistant seizures.

We are conducting an open-label Phase 2a clinical study of SPN-817 in patients with treatment-resistant seizures.

The first part of this study (Stage A) has completed dosing in the titration and maintenance periods.

We have completed enrollment of Stage A and announced in November 2024 the topline data from all subjects with focal seizures who received the 3mg and 4mg twice daily doses, completed the maintenance period (n=10), and enrolled in the post-maintenance extension period (n=6).

• Maintenance period:

◦ 56% median seizure reduction from baseline.

◦ 70% of subjects had 30% or more seizure reduction.

◦ 60% of subjects had 50% or more seizure reduction.

◦ 30% of subjects had 75% or more seizure reduction.

• Post-maintenance extension period:

◦ 66% median seizure reduction from baseline.

◦ 83% of subjects had 30% or more seizure reduction.

◦ 67% of subjects had 50% or more seizure reduction.

◦ 50% of subjects had 75% or more seizure reduction.

• Seizure Freedom:

◦ Maintenance period:

1 out of 10 subjects (10%) who completed a post-baseline seizure diary had at least one four-week seizure free period.

◦ Post-maintenance extension period:

1 out of 6 subjects (17%) had at least one four-week seizure free period.

Assessment by EpiTrack®, a validated cognitive screening tool designed for patients with epilepsy, indicated that 75% of 16 subjects was equally split between those who improved and those who had no change in cognitive function.

SPN-817 was safe and had acceptable tolerability with 2 subjects discontinuing because of treatment related adverse events out of the 26 subjects who entered the maintenance period.

The second part of this study (Stage B) is on-going and includes the use of a concomitant anti-emetic to reduce the cholinergic adverse events observed in the study.

We initiated a Phase 2b randomized, double-blind, placebo-controlled study of 3mg and 4mg twice daily doses in approximately 258 adult patients with treatment resistant focal seizures.

SPN-820 (NV-5138)

SPN-820 is a first-in-class, orally active small molecule that activates the brain mechanistic target of rapamycin complex 1 (mTORC1), a gatekeeper of cellular metabolism and renewal.

SPN-820 binds to and modulates sestrin, which senses amino acid availability in the brain, a potent natural activator of mTORC1.

Depression is associated with synapse loss and reduced synaptic plasticity in key brain regions including the prefrontal cortex and increasing mTORC1-mediated synaptic plasticity is a promising avenue to treat depression and associated symptoms.

SPN-820 selectively binds to intracellular sestrin proteins and subsequently engages a cascade of multi-protein complexes, enhancing mTORC1 signaling.

A single administration of SPN-820 rapidly (on within one hour) and transiently (off within seven hours) enhances intracellular mTORC1 signaling in the prefrontal cortex of animals, restores levels of synaptic proteins, reducing depressive-like behaviors in a brain-derived neurotrophic factor "BDNF"-dependent manner.

The rapid and transient enhancement of mTORC1 signaling in the prefrontal cortex is required for anti-depressant effects in preclinical animal models.

The intracellular mechanism of SPN-820, and the lack of binding to cell surface receptors, suggests the potential for a differentiated safety profile.

A Phase 1 trial demonstrated early proof of concept in which a single dose of SPN-820 showed a rapid and sustained improvement in core symptoms, with favorable safety and tolerability in patients with treatment resistant depression.

We believe the novel mechanism of action (MOA) in depression may improve symptoms of depression in patients who have failed other

We completed a Phase 2a multi-center open label study in 40 subjects with Major Depressive Disorder (MDD) in the fourth quarter of 2024.

The data were based on 40 enrolled subjects, of which 38 completed the ten-day treatment period.

The primary objective of the study was to assess efficacy in MDD, as well as the onset of efficacy.

The Phase 2a study demonstrated rapid and substantial decrease in depressive symptoms, and 80% decrease in suicidal ideation.

SPN-820 was well-tolerated during the study with few adverse events reported by the subjects.

In addition, the data demonstrated a rapid Montgomery–Asberg Depression Rating Scale (MADRS) response rate (≥50% reduction) and remission (MADRS ≤10), reaching 50.0% and 35.0% of subjects, respectively, at 4 hours, with additional improvement to 84.2% and 63.2% of participants by Day 10.

In February 2025, we reported topline results from the Phase 2b study of SPN-820.

The Phase 2b study of SPN-820 in adults with treatment-resistant depression did not demonstrate a statistically significant improvement on the primary endpoint of change from baseline in the MADRS total score to Week 4 (SPN-820 [LS mean ± Standard Error]:

-12.3 ± 0.96 vs.

-11.9 ± 0.96;

p = not significant).

There was no treatment difference between SPN-820 and placebo in the change from baseline to Week 4 for the secondary endpoints.

The safety profile of SPN-820 was consistent with previous clinical trials, showing few adverse events.

The Phase 2b study was a multi-center randomized double-blind placebo-controlled trial of SPN-820 in adults with treatment-resistant depression.

The study examined the efficacy and safety of SPN-820 over a course of four weeks of treatment and then a week of blinded placebo-washout in approximately 250 patients from approximately 40 clinical sites.

The primary outcome measure was the change from baseline to end of treatment period on the MADRS Total Score.

SPN-443 – Novel stimulant for the treatment of ADHD/CNS

We plan to initiate a Phase 1 single dose study in healthy adults in 2024 following submission of an Investigational New Drug Application.

The primary objective of the study is to assess the safety and tolerability.

We completed a Phase 1 single dose study in healthy adults in 2024 following submission of an Investigational New Drug Application.

The study was a first in human, pilot pharmacokinetic study of two oral formulations of SPN-443 in healthy adults.

The primary objective of the study was to assess the safety and tolerability.

This molecule, along with its major metabolites, is an inhibitor of norepinephrine, dopamine and serotonin, also known as a triple reuptake inhibitor.

Both formulations of SPN-443 showed adequate bioavailability and were well tolerated.

Sales and Marketing

We market our products through our own sales forces in the U.S.

We market our key products through our own sales forces in the U.S.

and seek strategic collaborations with other pharmaceutical companies to commercialize our products outside of the U.S.

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to support sales of our commercial products.

We believe our current sales forces are effectively targeting healthcare providers to support and grow our current commercial products.

As a result of the acquisitions in 2021 and 2020, we established our commercial capabilities in the Parkinson's area with a focus on serving movement disorder specialists and other specialized health care providers in the U.S.

With the launches of Qelbree for both pediatric and adult patients, we expanded our sales efforts to market the commercial product to the relevant physician audience of psychiatrists, pediatricians, primary care physicians and allied health professionals.

Our sales representatives who previously supported Trokendi XR and Oxtellar XR now devote their full efforts to the promotion of Qelbree.

We believe our current sales forces in the U.S.

are effectively targeting healthcare providers to support and grow our key commercial products.

One sales force focuses on serving movement disorder specialists and other specialized health care providers in the U.S.

in the Parkinson's area.

The second sales force focuses on serving psychiatrists, pediatricians, primary care physicians and other health professionals in the ADHD area.

The majority of our product sales are to pharmaceutical wholesalers, specialty pharmacies, and distributors who, in turn, sell our products to pharmacies, hospitals, and other customers, including federal and state entities.

The majority of sales of Oxtellar XR, Trokendi XR, Qelbree, and XADAGO are made to wholesalers and distributors.

The majority of sales of Qelbree, Oxtellar XR, Trokendi XR, and XADAGO are made to wholesalers and distributors.

In addition, MYOBLOC is available for direct purchase by physicians and hospitals.

The majority of sales of APOKYN, GOCOVRI, and Osmolex ER are made to specialty pharmacies.

The majority of sales of GOCOVRI and APOKYN, are made to specialty pharmacies.

Each of our three major customers, Cencora, Inc., Cardinal Health, Inc., and McKesson Corporation, individually accounted for more than 20% of our total product revenue in 2024 and collectively accounted for more than 77% of our total product revenue in 2024.

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W e are engaged in segments of the pharmaceutical industry that are highly competitive and rapidly changing.

Many large pharmaceutical and biotechnology companies, academic institutions, governmental agencies, and other public and private research organizations are commercializing or pursuing the development of products for the same molecule, compound, or diseases that we are currently pursuing or may target in the future.

Many large pharmaceutical and biotechnology companies, academic institutions, governmental agencies, and other public and private

research organizations are commercializing or pursuing the development of products for the same molecule, compound, or diseases that we are currently pursuing or may target in the future.

ADHD is a CNS disorder characterized by developmentally inappropriate levels of inattention, hyperactivity, and impul sivity.

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Also, it has a proven safety and tolerability profile, with no evidence of abuse potential in clinical studies.

Qelbree is the first nonstimulant treatment for ADHD approved by the FDA in over a decade.

Qelbree was the first novel nonstimulant treatment for ADHD approved by the FDA since 2011.

Parkinson's Disease

Parkinson's Disease is a progressive neurological disorder that is characterized by a loss of dopamine producing neurons in certain regions of the brain, causing symptoms like tremor, slowness of movement, stiffness, loss of balance, and lack of coordination.

PD is the second most common progressive neurodegenerative disorder, affecting 1-2% of individuals 65 years and older.

Patients with PD can also be affected with psychological symptoms such as anxiety, depression, aggression, and problems with cognition and memory.

As the disease progresses, some patients may lose the ability to independently perform the tasks of daily living.

The most commonly prescribed medicine for PD is levodopa.

PD patients are frequently prescribed levodopa to help replace dopamine, which is reduced in the brain.

However, motor disabilities as a result of levodopa wearing off remain a significant problem for over half of PD patients.

Patients in an "OFF" state, including those whose last dose of oral levodopa has worn off and whose next oral dose has not yet begun to take effect, can suffer from reduced coordination or mobility for several hours per day.

Carbidopa may be used along with levodopa to improve its efficacy and reduce the amount of levodopa needed to control PD symptoms.

There are a number of alternative adjunctive treatment options (FDA-approved and in clinical development) for Parkinson's patients, including various levodopa preparations, dopamine agonists, MAO-B inhibitors, and others.

APOKYN is given as needed as an adjunct to levodopa/carbidopa therapy in PD patients who experience "OFF" episodes.

In well-controlled clinical studies, APOKYN injections were effective in treating "OFF" periods, as measured by the motor function subset of the Unified Parkinson's Disease Rating Scale (UPDRS).

APOKYN, delivered via an injection pen, is for patients for whom oral levodopa will not sufficiently control "OFF" periods.

Patients taking APOKYN saw 95% of "OFF" episodes reversed, with improvement beginning as quickly as 10 minutes post-dosing in clinical studies.

With the alternative of immobility and limited function, we believe the rapid and reliable reduction of "OFF" episode symptoms is of utmost importance to patients.

APOKYN competes with pro re nata therapies such as Inbrija, and other adjunctive therapies, including NOURIANZ.

APOKYN also competes with other products for the treatment of PD, both branded such as VYALEV, and generic, including levodopa products.

For patients who experience significant "OFF" time each day, the Company has developed ONAPGO, formerly known as SPN-830, the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced PD.

The infusion may reduce the variability in motor symptoms of PD and offer improved tolerability versus the acute injection route.

The FDA approved ONAPGO in February 2025, and the Company will launch ONAPGO in the second quarter of 2025.

ONAPGO competes with VYALEV, and with other products for the treatment of PD, both branded and generic, including levodopa products.

For patients not ready to try parenteral therapy, oral MAO-B inhibitors, such as XADAGO, may provide a decrease in "OFF" time of up to one hour per day when combined with appropriate levodopa therapy.

In the XADAGO clinical trials, patients

experienced more beneficial "on" time, a time when Parkinson's symptoms are reduced, without troublesome uncontrolled involuntary movement (dyskinesia), compared to those receiving a placebo.

The increase in "on" time was accompanied by a reduction in "OFF" time and better scores on a measure of motor function assessed during "on" time than before treatment.

XADAGO competes with other MAO-B inhibitors used to treat "OFF" episodes in PD, including rasagiline (AZILECT) and selegiline (Zelapar and EMSAM).

XADAGO also competes with other products for the treatment of PD, both branded and generic, including levodopa products.

It is also the only medicine clinically proven to reduce both dyskinesia and “OFF” periods.

GOCOVRI, taken once daily at bedtime, provides an initial lag and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day.

Additionally, in the clinical trials, the adjunctive use of GOCOVRI did not require changes to dopaminergic therapies.

Epilepsy is a c omplex neurological disorder characterized by the spontaneous recurrence of unprovoked seizures, which are sudden surges of electrical activity in the brain that impair a person's mental and/or physical abilities.

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Trokendi XR competes with all immediate-release and extended-release topiramate products, including Topamax, Qudexy XR, and other generic topiramate products.

Oxtellar XR competes with all immediate-release oxcarbazepine products, including Trileptal and its related generic products.

Oxtellar XR competes with all immediate-release and extended-release oxcarbazepine products, including Trileptal and other generic oxcarbazepine products.

Both Oxtellar XR and Trokendi XR compete with other anti-epileptic products, both branded and generic.

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and amitriptyline.

Parkinson's Disease

PD is the second most common progressive neurodegenerative disorder, affecting 1-2% of individuals 65 years and older.

Patients with PD can also be affected with psychological symptoms such as anxiety, depression, aggression, and problems with cognition and memory.

As the disease progresses, some patients may lose the ability to independently perform the tasks of daily living.

The most commonly prescribed medicine for PD is levodopa.

PD patients are frequently prescribed levodopa to help replace dopamine, which is reduced in the brain.

However, motor disabilities as a result of levodopa wearing off remain a significant problem for over half of PD patients.

Patients in an "off" state, including those whose last dose of oral levodopa has worn off and whose next oral dose has not yet begun to take effect, can suffer from reduced coordination or mobility for several hours per day.

Carbidopa may be used along with levodopa to improve its efficacy and reduce the amount of levodopa needed to control PD symptoms.

APOKYN is given as needed as an adjunct to levodopa/carbidopa therapy in PD patients who experience "off" episodes.

In well-controlled clinical studies, APOKYN injections were effective in treating "off" periods, as measured by the motor function subset of the Unified Parkinson's Disease Rating Scale (UPDRS).

For patients for whom oral levodopa will not sufficiently control "off" periods, the Company has commercialized APOKYN, delivered via an injection pen.

Patients taking APOKYN saw 95% of "off" episodes reversed, with improvement beginning as quickly as 10 minutes post-dosing in clinical studies.

With the alternative of immobility and limited function, we believe the rapid and reliable reduction of "off" episode symptoms is of utmost importance to patients.

APOKYN competes with pro re nata therapies such as Inbrija, and other adjunctive therapies, including NOURIANZ.

APOKYN also competes with other products for the treatment of PD, both branded and generic, including levodopa products.

For patients who experience significant "off" time each day, the Company has developed a product candidate as a continuous infusion device (SPN-830) to deliver apomorphine subcutaneously.

The infusion may reduce the variability in motor symptoms of PD and offer improved tolerability versus the acute injection route.

The NDA for SPN-830 has been resubmitted and accepted for review by the FDA with a PDUFA date in April 2024.

For patients not ready to try parenteral therapy, oral MAO-B inhibitors, such as XADAGO, may provide a decrease in "off" time of up to one hour per day when combined with appropriate levodopa therapy.

In the XADAGO clinical trials, patients experienced more beneficial "on" time, a time when Parkinson's symptoms are reduced, without troublesome uncontrolled involuntary movement (dyskinesia), compared to those receiving a placebo.

The increase in "on" time was accompanied by a reduction in "off" time and better scores on a measure of motor function assessed during "on" time than before treatment.

XADAGO competes with other MAO-B inhibitors used to treat "off" episodes in PD, including rasagiline (AZILECT) and selegiline (Zelapar and EMSAM).

XADAGO also competes with other products for the treatment of PD, both branded and generic, including levodopa products.

It is also the only medicine clinically proven to reduce both dyskinesia and “off” periods.

GOCOVRI, taken once daily at bedtime, provides an

initial lag and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day.

Additionally, in the clinical trials, the adjunctive use of GOCOVRI did not require changes to dopaminergic therapies.

Osmolex ER is an extended-release tablet formulation that contains both immediate-release and extended-release amantadine, that is dosed once daily in the morning.

We believe Osmolex ER’s once-daily morning dose offers a more convenient option by reducing the number of pills a patient must take each day, which may improve patient compliance with treatment regimens.

While Osmolex ER is bioequivalent to immediate-release amantadine, the product provides a consistent delivery of amantadine throughout the day.

Peak serum drug concentration conveniently occurs in the middle portion of a patient’s day when the drug is administered in the morning.

According to their prescribing information, neither GOCOVRI nor Osmolex ER are interchangeable with other amantadine immediate- or extended-release products for their respective approved indications.

Cervical Dystonia

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This encompasses products for commercial use, as well as some products for preclinical and clinical research.

We do not own or operate manufacturing facilities for the production of any of our product candidates beyond that used in Phase II clinical trials, nor do we have plans to develop our own manufacturing operations in the foreseeable future to support Phase III clinical trials or commercial production.

We do not own or operate manufacturing facilities for the production of any of our product candidates beyond that used in Phase 2 clinical trials, nor do we have plans to develop our own manufacturing operations in the foreseeable future to support Phase 3 clinical trials or commercial production.

We currently employ internal resources to manage our manufacturing contractors.

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We rely on third-party CMOs in Asia for the manufacturing of bulk drug substance for Trokendi XR and Oxtellar XR and rely on a third-party CMO in Europe for the raw materials and manufacturing of Qelbree and GOCOVRI.

With respect to GOCOVRI, we have an additional manufacturer of bulk drug substance.

With respect to GOCOVRI and Qelbree, we have an additional manufacturer of bulk drug substance.

These CMOs offer a comprehensive range of contract manufacturing and packaging services.

We purchase APOKYN, MYOBLOC, XADAGO, and Osmolex ER as finished goods.

We purchase APOKYN, ONAPGO, MYOBLOC, and XADAGO, as finished goods.

APOKYN is manufactured and packaged in Europe for the U.S.

market and is supplied to us by our licensing partner, Britannia.

ONAPGO is manufactured in Europe, supplied to us by Britannia, and packaged in the U.S..

Britannia (a subsidiary of Stada Arzneimittel AG) also supplies injectable apomorphine to the European market under the brand name Apo-go.

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XADAGO is manufactured and packaged in Europe by Zambon S.p.A.

Osmolex ER is manufactured and packaged in the U.S.

by Osmotica Pharmaceutical US LLC (Osmotica), which is the sole manufacturer of Osmolex ER and a subsidiary of Osmotica Pharmaceuticals plc.

Refer to Part I, Item 1A — Risk Factors — If we fail to produce our products and product candidates in the volumes that we require on a timely basis or fail to comply with stringent regulations applicable to pharmaceutical drug manufacturers, we may face delays in the development and commercialization of our products and product candidates or be required to withdraw our products from the market for risks associated with manufacturing and supply of our products and product candidates.

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Qelbree, Trokendi XR and Oxtellar XR;

Adderall XR (developed for Shire);

Adderall XR (developed for Shire, which has been acquired by Takeda Pharmaceutical Company);

Intuniv (developed for Shire);

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We, or our subsidiaries, own all the issued patents for Trokendi XR, Oxtellar XR, Qelbree, GOCOVRI, Osmolex ER, as well as the pending U.S.

patent applications for Oxtellar XR, Qelbree, and GOCOVRI.

patent applications for Qelbree and GOCOVRI.

We have a license from Zambon for the U.S.

patents that cover XADAGO.

The Company has ongoing litigations concerning Trokendi XR, Oxtellar XR and XADAGO.

The Company has ongoing patent litigation concerning Trokendi XR.

For more information, refer to Part I, Item 3—Legal Proceedings in this Annual Report on Form 10-K.

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We own all the issued patents and the pending patent applications.

We currently have 10 U.S.

patents that cover Trokendi XR.

We own all the issued patents.

We also own additional foreign patents for extended-release topiramate.

The ten issued U.S.

patents covering Trokendi XR will expire no earlier than 2027.

The Company has entered into settlement agreements with third parties, permitting the sale of a generic version of Trokendi XR beginning in January 2023 and entitling the Company to receive royalties on those sales.

The patent portfolio covering GOCOVRI includes 19 U.S.

We have additional pending applications containing method and composition claims relating to the pharmacokinetic profile and dosing, and formulations of amantadine extended release.

The issued patents expire through 2038.

These patents and patent applications are owned by Adamas Operations and, as of the first quarter of 2022 are licensed to Supernus Pharmaceuticals, Inc.

Prior to our acquisition of Adamas, Adamas entered into settlement agreements with third parties, permitting the sale of a generic version of GOCOVRI (amantadine) extended-release capsules (including for any new indications approved under the GOCOVRI NDA) on or after June 4, 2029.

Our extended-release oxcarbazepine patent portfolio currently includes 14 U.S.

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We also own additional foreign patents for extended-release oxcarbazepine.

The Company has entered into settlement and license agreements with a third parties permitting the sale of a generic version of Oxtellar XR beginning in September 2024, or sooner under certain conditions, and entitling the Company to receive royalties on those sales.

The patent portfolio covering XADAGO has three U.S.

The Company entered into settlement and license agreements with third parties, permitting the sale of a generic version of Oxtellar XR beginning in September 2024.

We currently have 10 U.S.

patents that cover Trokendi XR.

We own all the issued patents.

We also own additional foreign patents for extended-release topiramate.

The ten issued U.S.

patents covering Trokendi XR will expire no earlier than 2027.

The patent portfolio covering XADAGO has 3 U.S.

patents licensed from Zambon.

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The Company has entered into settlement agreements with third parties, permitting the sale of a generic version of XADAGO beginning in December 2027, or earlier under certain circumstances.

The patent portfolio covering GOCOVRI includes 18 U.S.

We have additional pending applications containing method and composition claims relating to the pharmacokinetic profile and dosing, and formulations of amantadine extended release.

The issued patents expire through 2038.

These patents and patent applications are owned by Adamas Operations and, as of the first quarter of 2022 are licensed to Supernus Pharmaceuticals, Inc.

We, through our subsidiary Adamas Operations, own additional foreign patents and patent applications covering amantadine extended release.

Osmolex ER is covered for its FDA-approved indications by 18 issued U.S.

patents and additional applications containing method and composition claims relating to the pharmacokinetic profile and dosing, and formulations of amantadine extended release.

These issued patents expire through 2038.

These patents are wholly owned by Adamas Operations and, as of the first quarter of 2022 are licensed to Supernus Pharmaceuticals, Inc.

Adamas Operations also owns additional foreign patents covering Osmolex ER.

SPN-830 (apomorphine infusion device)

Our SPN-830 development program is potentially eligible to receive the Orphan Drug Designation in the U.S.

The Company plans to file for such designation with the FDA in 2024.

If such designation is granted by the FDA, SPN-830 would receive 7 years of U.S.

exclusivity from the time of approval by the FDA.

In February 2025, ONAPGO received Orphan Drug Designation in the U.S.

from the FDA.

ONAPGO received seven years of U.S exclusivity from the time of approval by the FDA.

SPN-817 (huperzine A)

We have one patent issued in the U.S., and in China and certain other countries relating to extended-release formulations of huperzine.

We have one patent issued in the U.S., and in China, Mexico, and certain other foreign countries relating to extended-release formulations of huperzine.

We additionally have pending patent applications in the U.S.

and certain foreign countries.

SPN-817 has received Orphan Drug designation for both Dravet Syndrome and Lennox-Gastaut Syndrome from the FDA.

SPN-820 (NV-5138)

Under the terms of the April 2020 Development Agreement with Navitor, we have an exclusive option to license or acquire NV-5138 in all world territories, prior to initiation of the Phase III clinical program.

Under the terms of the April 2020 Development Agreement with Navitor Pharmaceuticals, Inc.

(Navitor Inc.), we have an exclusive option to license or acquire NV-5138 in all world territories, prior to initiation of the Phase 3 clinical program.

NV-5138 has multiple patents issued covering composition of matter, various methods of use, etc.

and certain other foreign countries.

The issued patents have expiration dates of 2036-2038 or beyond.

There are additional pending patent applications in the U.S.

and certain foreign countries.

Other Intellectual Property Rights

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intellectual property laws:

"Supernus ® ", "Microtrol ® ", "Solutrol ® ", "Trokendi XR ® ", "Oxtellar XR ® ", "Qelbree ® ", "XADAGO ® ", "MYOBLOC ® ", "APOKYN ® ", "GOCOVRI ® ", "Osmolex ER ® ", "Namzaric ® ", and the registered Supernus Pharmaceuticals logo.

"Supernus ® ", "Microtrol ® ", "Qelbree ® ", "GOCOVRI ® ", "Oxtellar XR ® ", "APOKYN ® ", "Trokendi XR ® ", "XADAGO ® ", "MYOBLOC ® ", "Osmolex ER ® ", "Namzaric ® ", "ONAPGO TM ", and the registered Supernus Pharmaceuticals logo.

From time to time, we, including our subsidiaries, may find it necessary or prudent to obtain licenses from third party IP holders.

Where licenses are readily available at a reasonable cost, such licenses are considered a normal cost of doing business.

In other instances, however, we or our subsidiaries may use the results of freedom-to-operate inquiries and internal analyses to guide our early-stage research away from areas where we are likely to encounter obstacles in the form of third party IP.

In other instances, however, we or our subsidiaries may use the results of freedom-to-operate inquiries and internal analyses to guide

our early-stage research away from areas where we are likely to encounter obstacles in the form of third party IP.

For example, where a third party holds relevant IP and is a direct competitor, a license might not be available on commercially reasonable terms or at all.

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In the U.S., a patent's term may be lengthened via a patent term adjustment (PTA), which compensates a patentee for administrative delays by the USPTO in granting a patent.

Alternatively, a patent's term may be shortened if a patent is terminally disclaimed over another patent.

The mechanism for doing this is the filing by the applicant of a terminal disclaimer in order to overcome an issue of obviousness type double patenting.

Obviousness-type double patenting is a bar to patentability that is present when a patent application is deemed to be an obvious variant of a separate patent also assigned to the applicant.

The filing of a terminal disclaimer overcomes the issue which may allow a patent application to issue or preserve the validity of a patent but disclaims any portion of the second patent that extends beyond the expiration of the first patent and prevents the assertion of either patent against a defendant unless the patents are co-owned.

Because the filing of a terminal disclaimer is within the control of a patent, patent applicants generally avoid filing them when doing so would have a material adverse impact on the applicant’s interests.

A patent’s term can be shortened through a process called a "terminal disclaimer." This process can be undertaken when a patent application is considered too similar to another patent owned by the same applicant.

Without this process an applicant could be barred from obtaining a new related patent because it would be deemed to be an obvious variant of an existing patent.

By filing a terminal disclaimer, a new patent can be issued at the cost of the applicant acknowledging that the new patent cannot extend beyond the expiration of the original patent.

A new patent issued after the filing of a terminal disclaimer cannot be asserted against others unless the owner of the new patent also owns the previously existing patent that was the subject of the terminal disclaimer.

Recent legal decisions have shown that filing a terminal disclaimer can reduce any extra time added to a patent’s term due to delays in the patent approval process.

Patent applicants typically avoid filing terminal disclaimers when doing so would negatively affect their interests.

In evaluating the patentability of a claimed invention, the filing date of a non-provisional patent application is used by the USPTO to determine what information constitutes prior art.

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Similar provisions to extend the term of a patent that covers an approved drug are available in Europe and other foreign jurisdictions.

In the f uture, if and when our pharmaceutical products receive FDA or other regulatory approval, we may be able to apply for PTEs on patents covering those products.

In the f uture, if any of our product candidates receive FDA or other regulatory approval, we may be able to apply for PTEs on patents covering those products.

Depending upon the timing, duration, and specifics of FDA approval and the issuance of a U.S.

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Under these in-licensing agreements, we or our subsidiaries may be required to pay certain amounts upon the achievem ent of defined milestones.

If these products are ultimately commercialized, we or the applicable subsidiary are also obligated to pay royalties to third parties, computed as a percentage of net product sales, for each respective product under a license agreement.

If these products are ultimately commercialized,

we or the applicable subsidiary are also obligated to pay royalties to third parties, computed as a percentage of net product sales, for each respective product under a license agreement.

We, including our subsidiaries, also have entered into out-licensing agreements to license our intellectual property and technology or that of our subsidiaries to third parties.

Under these out-license agreements, we or our subsidiaries may be entitled to receive certain amounts upon the achievement of defined milestones and royalties from third parties, generally computed as a percentage of net product sales, for each respective product under a license agreement.

APOKYN and SPN-830 (apomorphine infusion device)

APOKYN and ONAPGO (apomorphine hydrochloride)

In January 2016, we entered into an Amended and Restated Distribution, Development, Commercialization, and Supply Agreement with Britannia that grants us certain intellectual property and product rights in relation to APOKYN, including the right to use and market APOKYN in the United States (Territory).

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Under the agreement, we are obligated to pay Britannia a royalty based upon U.S.

net sales, adjusted for other product related costs for APOKYN, SPN-830 and any other commercial products jointly developed under the agreement.

net sales, adjusted for other product related costs for APOKYN, ONAPGO (formerly known as SPN-830), and any other commercial products jointly developed under the agreement.

The parties have also agreed to a cost sharing arrangement for the development of new products beyond APOKYN.

Under the agreement, we are obligated to pay more than half of the related costs associated with the development of SPN-830 or other new products that are commercialized solely by the Company in the U.S.

For costs associated with new products that are commercialized both inside and outside the Territory, we are obligated to pay less than half of related costs.

Under the agreement, we are obligated to pay more than half of the related costs associated with the development of ONAPGO (formerly known as SPN-830) or other new products that are commercialized solely by the Company in the U.S.

For costs associated with new products that are commercialized both inside and outside the Territory, we are obligated to pay less than half of the related costs.

We have agreed to use commercially reasonable efforts to develop and commercialize products under the agreement.

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The agreement may not be terminated for convenience.

In June 2023, we terminated the agreement with Elan and Eisai related to the marketing and distribution of NerBloc in Japan by Eisai.

We have a contract manufacturing agreement with Merz Pharma GmbH & Co.

KGaA (Merz) for the manufacture and supply of MYOBLOC and NerBloc (Merz Agreement).

KGaA (Merz) for the manufacture and supply of MYOBLOC (Merz Agreement).

Pursuant to the Merz Agreement, Merz is required to provide a dedicated manufacturing facility including a stand-alone building, dedicated clean room suites, dedicated manufacturing and purification equipment, and filling and packaging production lines (collectively, the manufacturing facility) to manufacture finished products.

The Merz Agreement will expire in July 2027, unless the Company and Merz mutually agree to extend the term.

The Merz Agreement may not be terminated for convenience.

Agreement may not be terminated for convenience.

Under the terms of the Merz Agreement, the Company is required to purchase a minimum quantity of finished products on an annual basis.

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The Company has an annual minimum purchase quantity requirement of finished products.

Our subsidiary Adamas Operations has the global rights to Osmolex ER.

Pursuant to the Asset Purchase Agreement with Osmotica Pharmaceutical US LLC and Vertical Pharmaceuticals LLC (Osmotica) entered into on December 1, 2020 (transaction closed on January 4, 2021).

Osmotica agreed not to engage in the development, manufacture, or sale of any product in the U.S.

that is a generic version of any dosage strength of Osmolex ER for a period of five years from the closing of the Asset Purchase Agreement.

SPN-817 (huperzine A)

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SPN-820 (NV-5138)

In April 2020, we entered into a Development and Option Agreement with Navitor to collaborate on a clinical development program for NV-5138 (SPN-820), Navitor's mTORC1 activator.

Under the terms of the agreement, the Company and Navitor will jointly conduct a Phase II clinical program in TRD.

We will pay the costs of Phase II development up to $50 million, plus certain costs associated with nonclinical development and formulation.

In addition, Navitor has granted the Company an exclusive option to license or acquire NV-5138 in all world territories, prior to initiation of the Phase III clinical program.

We paid Navitor a one time, nonrefundable, and non-creditable fee of $10 million for the option to acquire or license NV-5138 (SPN-820) and made a $15 million equity investment representing approximately 13% ownership in Navitor.

In December 2021, we received a $12.9 million cash distribution pursuant to our ownership position in Navitor LLC following the

sale of one of its subsidiaries.

There are certain additional payment amounts that could be incurred by the Company.

These costs are contingent upon Navitor and the Company achieving defined development milestones.

Total payments, exclusive of royalty payments on net sales of NV-5138 and development costs under the agreement, have the potential to reach $410 million to $475 million, which includes the upfront payment of $25 million paid in 2020, an additional license or acquisition fee depending on whether the Company ultimately licenses or acquires NV-5138, and subsequent clinical, regulatory and sales based milestone payments.

We also will have the first right of refusal for any compound with a similar MOA to NV-5138 on mTORC1 in the central nervous system.

In April 2020, we entered into a development agreement (the Development Agreement) with Navitor Inc.

We can terminate the Development Agreement upon 30 days' notice.

Under the terms of the Development Agreement, the Company and Navitor Inc.

will jointly conduct a Phase 2 clinical program for NV-5138 (SPN-820) for treatment-resistant depression.

We will bear all of the Phase 1 and Phase 2 development costs incurred by either party, up to a maximum of $50 million, which amount could be increased under the terms of the Development Agreement upon Navitor Inc.’s request and the Company’s consent.

In 2020, we paid a one-time, nonrefundable, and non-creditable fee of $10 million for the option to acquire or license NV-5138 (SPN-820) and made a $15 million equity investment representing approximately 13% ownership in Navitor Inc.

There are also certain additional payments which could be incurred by us that are contingent upon Navitor Inc.

achieving defined milestones.

These payments include an additional license or acquisition fee depending on whether we ultimately license or acquire NV-5138 (SPN-820), and subsequent clinical, regulatory and sales milestone payments.

The total payments, exclusive of the royalty payments on net sales of NV-5138 (SPN-820) and development costs paid by us under the agreement, have the potential to reach $410 million to $475 million, which includes an aggregate upfront payment of $25 million paid in 2020 for the option to acquire or license NV-5138 (SPN-820) and the equity investment, an additional license or acquisition fee depending on whether we ultimately license or acquire NV-5138 (SPN-820), and subsequent clinical, regulatory and sales based milestone payments.

We also will have the first right of refusal for any compound with a similar mechanism of action to NV-5138 (SPN-820) on mTORC1 in the central nervous system.

In addition to entering into the Development Agreement in April 2020, as above mentioned, we acquired Series D Preferred Shares of Navitor Inc.

(the Navitor Shares), an equity investment representing an approximately 13% ownership position in Navitor Inc.

As part of a legal restructuring in March 2021, our Navitor Inc.

Shares were exchanged for membership interests in Navitor Pharmaceutics LLC (Navitor LLC), which became the sole shareholder of Navitor Inc.

In the second quarter of 2024, we consented to payment of additional Phase 2 development costs for NV-5138 (SPN-820) as they are incurred, but reserve the right to terminate payment of future development costs at our discretion.

See Part II, Item 8, Financial Statements and Supplementary Data , Note 4 , Investments , in the Notes to the Consolidated Financial Statements.

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Alternatively, the Namzaric ANDA filers with the earliest license date have the option to launch an authorized generic version of Namzaric beginning on January 1, 2026 instead of launching their own generic version of Namzaric on January 1, 2025.

In January 2025, Amneal Pharmaceuticals, Inc.

received approval from the FDA and has launched a generic version of Namzaric.

Adamas expects that it will not receive royalties from sale of Namzaric after the entry of the generic version of Namzaric in January 2025.

Adamas expects that it will not receive royalties on sales of NAMENDA XR because of the entry of multiple generic versions of NAMENDA XR.

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In some cases, we are also entitled to milestone payments.

With respect to Oxtellar XR, Trokendi XR, and Qelbree, we have entered into collaboration and licensing agreements with third parties to commercialize these products outside of the U.S.

With respect to Qelbree, Oxtellar XR, and Trokendi XR, we have entered into collaboration and licensing agreements with third parties to commercialize these products outside of the U.S.

Under certain licensing arrangements, we are eligible to receive royalties based on net product sales as defined in the agreements and in some cases, we are also entitled to milestone payments.

We currently receive royalties from third parties related to agreements for Trokendi XR.

The Company has also entered into settlement and licensing agreements with generic companies to settle patent litigation and to grant non-exclusive licenses to market generic versions of Trokendi XR and Oxtellar XR in the U.S.

Under certain licensing arrangements, the Company is eligible to receive royalties based on net product sales as defined in the and the number of generic equivalent products on the market in the U.S.

We currently receive royalties from third parties related to certain agreements for Trokendi XR.

We currently receive royalties from third parties related to agreements for Trokendi XR and Oxtellar XR.

Under certain licensing arrangements, the Company is eligible to receive royalties based on net product sales as defined in the agreements, and the number of generic equivalent products on the market in the U.S.

We currently receive royalties from third parties related to certain agreements for Trokendi XR and Oxtellar XR.

Confidential Information and Inventions Assignment Agreements

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These agreements provide that all confidential information developed by or made known during the course of the relationship with us or our subsidiaries be kept confidential and not disclosed to third parties, except in specific circumstances.

For example, nothing in any policy or agreement prohibits (i) reporting any possible violations of applicable laws, rules, or regulations to any governmental agency or government entity or (ii) making any other disclosures that are protected under federal, state, or local laws or regulations in the United States.

The agreements provide that all inventions resulting from work performed for us or relating to our business and conceived of or completed by the individual during employment or assignment, as applicable, shall be our exclusive property or the exclusive property of the applicable subsidiary, in each case, to the extent permitted by applicable law.

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While these are generally conducted in three sequential phases, the phases may overlap or be combined.

• Phase I - Involves the first human tests of the drug, in a small number of healthy volunteers or in patients, to assess safety, tolerability, potential dosing, and if possible, early evidence on effectiveness.

• Phase II - Involves trials in a relatively small group of patients to determine the effectiveness of the drug for a particular indication(s);

• Phase 1 - Involves the first human tests of the drug, in a small number of healthy volunteers or in patients, to assess safety, tolerability, potential dosing, and if possible, early evidence on effectiveness.

• Phase 2 - Involves trials in a relatively small group of patients to determine the effectiveness of the drug for a particular indication(s);

dosage tolerance, and optimum dosage;

and to identify common adverse effects and safety risks.

• Phase III - Involves tests confirming favorable results in earlier phases, in a significantly larger patient population, and to further demonstrate efficacy and safety.

Phase III trials include both a control group that receives the standard treatment and a study group that receives the new treatment that is being tested.

• Phase 3 - Involves tests confirming favorable results in earlier phases, in a significantly larger patient population, and to further demonstrate efficacy and safety.

Phase 3 trials include both a control group that receives the standard treatment and a study group that receives the new treatment that is being tested.

Clinical trials must be conducted in compliance with applicable regulations and consistent with acceptable clinical practices, as well as protocols detailing not only the objectives of the trial, but also the parameters to be used in monitoring safety of study participants, and/or the parameters to determine effectiveness.

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There is no guarantee when, or if, a product candidate will receive the regulatory approval required to launch a new drug or new indication of an existing drug.

In addition to the development of new products and new formulations, research and development projects also may include Phase IV trials, sometimes called post-marketing studies.

In addition to the development of new products and new formulations, research and development projects also may include Phase 4 trials, sometimes called post-marketing studies.

For such projects, clinical trials are designed and conducted to collect additional data regarding, among other parameters, the benefits and risks of an approved drug.

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Drug development is an inherently uncertain process with a high risk of failure at every stage of development.

After the completion of the required clinical testing, an NDA or Biological License Application (BLA) (hereinafter "NDA") is prepared and submitted to the FDA.

After the completion of the required clinical testing, an NDA or Biological License Application (hereinafter NDA) is prepared and submitted to the FDA.

FDA approval of the NDA is required before marketing of the product may begin in the U.S.

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During the review period, the FDA will typically inspect one or more clinical sites to assure compliance with good clinical practice regulations.

The FDA may rely on a recent inspection of the facility, or they may decide to inspect the facility(ies) at which the drug is manufactured to ensure compliance with cGMP regulations.

The FDA may rely on a recent inspection of the facility, or they may decide to inspect each facility at which the drug is manufactured to ensure compliance with cGMP regulations.

The FDA may also undertake an audit of nonclinical and clinical sites.

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As a condition of NDA approval, the FDA may require a risk evaluation and mitigating strategy (REMS) to help ensure that the benefits of the drug outweigh the potential risks.

REMS can include medication guides, communication plans for health care professionals, and elements to assure safe use, such as restricted distribution methods, patient registries, and other risk

minimization tools.

REMS can include medication guides, communication plans for health care professionals, and elements to assure safe use, such as restricted distribution methods, patient registries, and other risk minimization tools.

Moreover, as a condition to product approval, the FDA may require substantial post-marketing testing and surveillance to monitor the drug's safety or efficacy in commercial use and may impose other conditions, including distribution and labeling restrictions, which can materially affect the potential addressable market and profitability of the drug.

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This could restrict the commercial value of the product.

Also, the FDA may require that certain contraindications, warnings, or precautions be included in the product labeling, as well as requiring Phase IV testing or post approval marketing of commercial use.

Also, the FDA may require that certain contraindications, warnings, or precautions be included in the product labeling, as well as requiring Phase 4 testing or post approval marketing of commercial use.

New Drug Application

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Notwithstanding the approval of many products by the FDA pursuant to Section 505(b)(2) over the last few years, some pharmace utical companies and others have objected to the FDA's interpretation of Section 505(b)(2).

If the FDA changes its

interpretation of Section 505(b)(2), or if the FDA's interpretation is successfully challenged in court, this could delay or even prevent the FDA from approving any Section 505(b)(2) NDA that we submit.

If the FDA changes its interpretation of Section 505(b)(2), or if the FDA's interpretation is successfully challenged in court, this could delay or even prevent the FDA from approving any Section 505(b)(2) NDA that we submit.

By its very nature, a Section 505(b)(1) NDA submission carries a higher degree of regulatory approval risk than a Section 505(b)(2) NDA submission.

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Under the Pediatric Research Equity Act of 2007 (PREA), NDAs or supplements to NDAs must contain data to assess the safety and effectiveness of the drug for the claimed indication(s) in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the drug is safe and effective.

The intent of the PREA is to compel sponsors whose drugs have pediatric applicability to study those drugs in pediatric populations, rather than ignoring pediatric

indications for adult indications that could be more economically desirable.

The intent of the PREA is to compel sponsors whose drugs have pediatric applicability to study those drugs in pediatric populations, rather than ignoring pediatric indications for adult indications that could be more economically desirable.

The FDA may grant deferrals for submission of data, full waivers, or partial waivers of the data requirements.

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Among the other benefits of an Orphan Drug Designation, are tax credits for certain research expenses and waiver of the NDA application user fee for the orphan indication.

However, a competitor obtaining orphan product exclusivity for a therapeutic agent before we do, could block the approval of one of our products for seven years for the same indication, unless we are able to demonstrate that our product is clinically superior, or the competitor cannot supply sufficient quantities of the product.

However, a competitor obtaining orphan product exclusivity for a therapeutic agent

before we do, could block the approval of one of our products for seven years for the same indication, unless we are able to demonstrate that our product is clinically superior, or the competitor cannot supply sufficient quantities of the product.

Priority Review

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Adverse event reporting and submission of periodic reports is required following marketing approval.

The FDA may also require post-marketing testing, known as Phase IV testing, REMS, and surveillance to monitor the effects of an approved product, or place conditions on an approval that could restrict the distribution and use of the product.

The FDA may also require post-marketing testing, known as Phase 4 testing, REMS, and surveillance to monitor the effects of an approved product, or place conditions on an approval that could restrict the distribution and use of the product.

In addition, quality control, as well as the manufacture, packaging and labeling procedures must continue to conform to cGMPs after approval.

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However, patent term restoration cannot extend the remaining term of a patent beyond a total of 14 years from the product's approval date.

The patent term restoration period is generally 50% of the time between the effective date of an IND and the submission date of an NDA, plus the time between the submission date of an NDA and the approval of that application.

Only one patent applicable to an approved drug is eligible for the extension, and the application for the extension must be submitted prior to the expiration of the patent and within sixty days of approval of the drug.

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Department of Health and Human Services and to have prepared an annual audit by an Independent Review Organization.

The Company submitted its final report during the second quarter of 2024 and currently expects the review of its report for the final Reporting Period to conclude during the first half of 2025.

The CIA sets forth potentially substantial stipulated monetary penalties for non-compliance with the terms of the agreement.

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The Federal Open Payments program requires certain manufacturers, including those that engage in the production, preparation, propagation, compounding, or conversion of drugs, devices, biological, and medical supplies for which payment is available under Medicare, Medicaid, or the Children's Health Insurance Program, with certain exceptions, to report annually to the federal government information related to payments and other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists, and chiropractors) and teaching hospitals, as well as certain ownership and investment interests held by physicians and their immediate family members.

Effective with the 2022 report filing, we are also required to report information regarding payments and other transfers of value provided during the previous year to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists and anesthesiologist assistants, and certified nurse-midwives.

We are also required to report information regarding payments and other transfers of value provided during the previous year to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists and anesthesiologist assistants, and certified nurse-midwives.

Foreign Corrupt Practices Act (FCPA), to which we are also subject, prohibits corporations and individuals from engaging in certain activities to obtain or retain business or influence a person working in an official capacity.

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Failure to comply with such laws and regulations could result in government enforcement actions and create liability for us (including the imposition of significant penalties), private litigation and/or adverse publicity that negatively affects our business.

In addition, healthcare providers who prescribe our products and research institutions we collaborate with are subject to privacy and security requirements under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended

by the Health Information Technology for Economic and Clinical Health Act (HITECH).

HIPAA and its implementing regulations impose certain requirements on covered entities, including certain healthcare providers, health plans, and healthcare clearinghouses as well as their respective business associates (including us) that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity and their subcontractors that use, disclose, access, or otherwise process individually identifiable protected health information, relating to the privacy, security and transmission of individually identifiable health information.

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Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development.

The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, collectively known as the Affordable Care Act (ACA), substantially changed the way healthcare is financed by both governmental

and private insurers and significantly impacted the pharmaceutical industry.

Federal, state, and local governments in the U.S.

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Future legislation could limit payments for pharmaceuticals, such as the product candidates that we are developing.

The Inflation Reduction Act of 2022 (“IRA”) includes measures intended to lower the cost of prescription drugs and related healthcare reforms, such as limits on price increases and subjecting an escalating number of drugs to annual price negotiations with CMS.

Specifically, the IRA authorizes and directs HHS to set drug price caps for certain high-cost Medicare Part B and Part D qualified drugs, with the initial list of drugs announced on August 29, 2023.

The negotiated maximum fair prices for such drugs is scheduled to be announced by September 1, 2024, with the first year of maximum price applicability to begin in calendar year 2026.

The Inflation Reduction Act of 2022 (IRA) includes measures intended to lower the cost of prescription drugs and related healthcare reforms, such as limits on price increases and subjecting an escalating number of drugs to annual price negotiations with Centers for Medicare & Medicaid Services (CMS).

Specifically, the IRA authorizes and directs HHS to set drug price caps for certain high-cost Medicare Part B and Part D qualified drugs, with the initial list of drugs announced in August 2023.

On August 14, 2024, CMS announced that it had selected 10 drugs covered under Medicare Part D for negotiation for initial maximum price applicability for calendar year 2026.

None of the selected drugs were Supernus products.

The IRA also authorizes HHS to penalize pharmaceutical manufacturers that increase the price of certain Medicare Part B and Part D drugs faster than the rate of inflation.

The IRA also creates significant changes to the Medicare Part D benefit design by capping Part D beneficiaries' annual out-of-pocket spending.

The marketability of any drug candidates for which we receive regulatory approval for commercial sale may suffer if the government and third-party payors fail to provide adequate coverage and reimbursement.

The marketability of any product candidates for which we receive regulatory approval for commercial sale may suffer if the government and third-party payors fail to provide adequate coverage and reimbursement.

In addition, emphasis on managed care in the United States has increased, and we expect will continue to increase the pressure on pharmaceutical drug pricing.

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states have passed, or are in the process of passing, new regulations designed to increase pricing transparency associated with pharmaceutical manufacturers.

Many states have determined that it's in their preferred interest to take legislative action in order to curb drug price increases and to decrease their annual pharmaceutical spend.

Many states have determined

that it's in their interest to take legislative action in order to curb drug price increases and to decrease their annual pharmaceutical spending.

This momentum is likely to continue in the years ahead.

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We believe a hazard-free environment is critical for the success of our business.

Throughout our operations, we strive to ensure that all our employees have access to safe

workplaces that allow them to succeed in their jobs.

Throughout our operations, we strive to ensure that all our employees have access to safe workplaces that allow them to succeed in their jobs.

Our experience and continuing focus on workplace safety has enabled us to preserve business continuity without sacrificing our commitment to keeping our colleagues and workplace visitors safe.

Inclusion and Diversity

We place a strong value on collaboration, inclusion, and diversity, and we believe that working together leads to better outcomes for our customers.

We place a strong value on collaboration and we believe that working together leads to better outcomes for our customers.

This extends to the way we treat each other as team members.

We strive to create an environment where innovative ideas can flourish by demonstrating respect for each other and valuing the diverse opinions, backgrounds, and viewpoints of employees.

We believe a diverse and inclusive workplace results in business growth and encourages increased innovation, retention of talent, and a more engaged workforce.

We strive to create an environment where innovative ideas can flourish by demonstrating respect for each other and valuing the opinions,and viewpoints of employees.

We believe a collaborative workplace results in business growth and encourages increased innovation.

In recent years we have been named to a number of best company lists, including the 2021 Forbes Best Small Companies list and the 2020 Best of Rockville – Pharmaceutical Companies list.

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• We are dependent on the commercial success of our products in the U.S.

• If generics or other versions of our products including generics containing oxcarbazepine.

topiramate, apomorphine hydrochloride, amantadine, or viloxazine hydrochloride, are approved and successfully commercialized, our business could be materially harmed.

• If generics or other versions of our products including generics containing one or more of the active pharmaceutical ingredients present in our products are approved and successfully commercialized, our business could be materially harmed.

• We are subject to uncertainty relating to payment or managed care reimbursement policies, which, if not favorable for our products or product candidates, could hinder or prevent our commercial success.

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If we lose any of our significant wholesaler, distributor, or specialty pharmacy accounts, our business could be harmed.

RISK FACTORS.

• Final marketing approval of any of our product candidates or approval of additional indications for existing products by the FDA or other regulatory authorities may be delayed, limited, or denied, any of which would adversely affect our ability to generate operating revenues.

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• Healthcare cost containment legislation and the failure of third-party payors to provide appropriate levels of coverage and reimbursement for the use of products and treatments facilitated by our products could harm our business and prospects.

RISK FACTORS.

• Any failure to comply with healthcare regulations, including implementation of any change in compliance with healthcare regulations and laws could cause us to incur significant compliance expenses and any failure to comply could subject us to substantial penalties and fines.

Our business, operations, and financial condition could be adversely affected.

• We could be involved in lawsuits to protect or enforce our patents, which could be expensive, time consuming, distracting, and ultimately unsuccessful.

• We could be involved in additional lawsuits to protect or enforce our patents, which could be expensive, time consuming, distracting, and ultimately unsuccessful.

• Limitations on our patent rights relating to our products and product candidates may limit our ability to prevent third parties from competing with us.

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• Any impairment in the value of our intangible assets, including goodwill, would negatively affect our operating results and total capitalization.

• Our Credit Line is secured by a portfolio of marketable securities and we may be required to post additional collateral.

RISK FACTORS.

Risks Related to Securities Markets and Investment in Our Stock

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Our major products Qelbree ® , GOCOVRI ® , Oxtellar XR ® , and APOKYN ® , represented approximately 38%, 20%, 16%, and 12% of our total net revenues for the year ended December 31, 2024, respectively.

If any of our major products, including were to become subject to problems, such as changes in prescription growth rates, unexpected side effects, loss of intellectual property protection, supply chain or product supply shortages, regulatory proceedings, changes in labeling, publicity adversely affecting doctor or patient confidence in our product, material product liability litigation, pressure from new or existing competitive products, or adverse changes in coverage under managed care programs, the adverse impact on our revenue and profit could be significant.

As noted in the "Business" section of this report, sales of a generic version of Trokendi XR ® began in January 2023 and those competitive products have significantly impacted the sales of Trokendi XR and have had an adverse impact on our revenue and profit.

If any of our major products were to become subject to problems, such as changes in prescription growth rates, unexpected side effects, loss of intellectual property protection, supply chain or product supply shortages, regulatory proceedings, changes in labeling, publicity adversely affecting doctor or patient confidence in such product, material product liability litigation, pressure from new or existing competitive products, or adverse changes in coverage under managed care programs, the adverse impact on our revenue and profit could be significant.

RISK FACTORS.

the "Business" section of this report, sales of a generic version of Trokendi XR ® and Oxteller XR ® began in January 2023 and September 2024, respectively.

Those competitive products have significantly impacted the sales of Trokendi XR and Oxtellar XR, resulting in an adverse impact on our revenue and profit.

In addition, our revenue and profit could be significantly impacted by the timing and rate of commercial acceptance of key new products.

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• Adequately protect against and effectively respond to any claims by holders of patents and other IP rights alleging that our products infringe their rights;

RISK FACTORS.

• Adequately protect against and effectively respond to any unanticipated adverse effects or unfavorable publicity that develops with respect to our products, as well as respond to the emergence of new or existing competitive products, which may be proven to be more clinically effective and cost-effective.

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cause us to modify how we market our approved products;

subject us to substantial liabilities;

subject us to

RISK FACTORS.

substantial liabilities;

and adversely affect our revenues and financial condition.

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If we are not successful in broadening and/or maintaining the current commercial acceptance of our products, such that we cannot achieve those revenue expectations with respect to such products, this could result in a material adverse impact on our anticipated revenue, earnings, and liquidity.

If generics or other versions of our products including generics containing oxcarbazepine.

topiramate, apomorphine hydrochloride, amantadine, safinamide or viloxazine hydrochloride, are approved and successfully commercialized, our business could be materially harmed.

Third parties have, and in the future may, receive approval to manufacture and market their own versions of extended-release topiramate in the U.S.

If generics or other versions of our products including generics containing one or more of the active pharmaceutical ingredients present in our products are approved and successfully commercialized, our business could be materially harmed.

Third parties have, and in the future may, receive approval to manufacture and market their own versions of products containing one or more of the active pharmaceutical ingredients present in our products in the U.S.

For example, Upsher-Smith launched Qudexy XR (extended-release topiramate) and a branded generic version of Qudexy XR in 2014.

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market with its own therapeutically equivalent generic products to Qudexy XR.

The Company has entered into settlement agreements with third parties permitting the sale of a generic version of Trokendi XR on January 1, 2023.

Sales of generic versions of Trokendi XR ® began in 2023.

The Company has also entered into settlement and license agreements with third parties permitting the sale of the first generic version of Oxtellar XR beginning in September 2024, or sooner under certain conditions, and entitling the Company to receive royalties on those sales.

The Company has entered into settlement and license agreements with third parties, which permit the sale of generic versions of Trokendi XR and Oxtellar XR on January 2023 and September 2024, respectively.

Sales of generic versions of Trokendi XR and Oxtellar XR began in 2023 and 2024, respectively.

The Company has also entered into settlement and license agreements with third parties permitting the sale of the first generic version of XADAGO beginning in December 2027, or sooner under certain conditions.

We have the right to defend our products against third parties who may infringe or are infringing our patents.

Other third parties in the future may receive approval to manufacture and market their own versions of extended-release oxcarbazepine or generics of Oxtellar XR in the U.S.

In addition, we are aware of companies who are marketing modified-release oxcarbazepine products outside of the U.S., such as Apydan, which was developed by Desitin Arzneimittel GmbH and which requires twice-daily administration.

If companies with modified-release oxcarbazepine products outside of the U.S.

pursue or obtain approval of their products within the U.S., such competing products may limit the potential success of Oxtellar XR in the U.S.

Our business and growth prospects could be materially impaired.

RISK FACTORS.

Accordingly, if any third party is successful in obtaining approval to manufacture and market a generic or its own version of extended-release oxcarbazepine or topiramate in the U.S., we may not be able to prospectively realize revenues from Oxtellar XR or Trokendi XR.

In addition, third parties have, and in the future may, receive approval to manufacture and market their own products, including generics containing apomorphine hydrochloride for the treatment of Parkinson’s Disease in the U.S.

For example, Acorda Therapeutics, Inc.

launched Inbrija, an inhalable form of levodopa in 2019 and Sunovion Pharmaceuticals, Inc.'s (Sunovion, a subsidiary of Sumitomo Dainippon Pharma Co.

Ltd) launched KYNMOBI, a sublingual film formulation of apomorphine hydrochloride, in 2020.

In February 2022, the FDA approved the first generic of APOKYN (apomorphine hydrochloride injection) to treat hypomobility "off" episodes ("end-of-dose wearing off" and unpredictable "on/off" episodes) associated with advanced Parkinson's Disease.

This approval is for an application of the drug cartridges only, which are compatible for use with the APOKYN pen, the brand-name pen injector.

Third parties have, and in the future may, receive approval to manufacture and market their own products, including generics containing apomorphine hydrochloride, for the treatment of Parkinson’s Disease in the U.S.

For example, in 2019, Acorda Therapeutics, Inc.

launched Inbrija (acquired by Merz Pharmaceuticals, LLC in July 2024), an inhalable form of levodopa and Sunovion Pharmaceuticals, Inc.

(Sunovion, a subsidiary of Sumitomo Dainippon Pharma Co.

Ltd) launched KYNMOBI, a sublingual film formulation of apomorphine hydrochloride, in 2020 (later withdrawn from the U.S.

in June 2023).

In February 2022, the FDA approved the first generic containing apomorphine hydrochloride to treat hypomobility "OFF" episodes ("end-of-dose wearing off" and unpredictable "ON/OFF" episodes) associated with advanced Parkinson's Disease.

This approval was for the drug cartridges only, which according to the FDA’s press release are to be used with the APOKYN pen, the brand-name pen injector, as the generic manufacturer did not seek approval of its own pen.

Patients treated with generic apomorphine hydrochloride will need to separately obtain the APOKYN pen.

The success of these products and the entry of new products could adversely impact the sales of APOKYN.

If any third party is successful in obtaining approval to manufacture and market a generic or its own version of safinamide in the U.S., we may not be able to prospectively realize revenues from XADAGO.

Third parties in the future may receive approval to manufacture and market their own versions of viloxazine hydrochloride.

Accordingly, if any third party is successful in obtaining approval to manufacture and market its own version of viloxazine hydrochloride, such competing products may limit the potential success of Qelbree in the U.S.

Our business and growth prospects could be materially impaired.

To the extent any third party is successful in obtaining approval to manufacture and market a generic or its own version of a product containing one or more of the active pharmaceutical ingredients present in our products in the U.S., we may not be able to prospectively realize revenues from such products.

Accordingly, our business and growth prospects could be materially impaired.

We are subject to uncertainty relating to payment or managed care reimbursement policies, which, if not favorable for our products or product candidates, could hinder or prevent our commercial success.

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These prices are sometimes characterized as excessive, leading to government investigations and legal proceedings regarding pharmaceutical pricing practices.

Our ability, or our collaborators' ability, to successfully commercialize our products and product candidates, including Qelbree and SPN-830, will depend in part on the coverage and reimbursement levels set by governmental authorities, private health insurers, managed care organizations, and other third-party payors.

Our ability, or our collaborators' ability, to successfully commercialize our products and product candidates, including Qelbree and ONAPGO (formerly known as SPN-830), will depend in part on the coverage and reimbursement levels set by governmental authorities, private health insurers, managed care organizations, and other third-party payors.

As a threshold for coverage and reimbursement, third-party payors require that drug products be approved for marketing by the FDA.

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Government authorities and third-party payors have attempted to control costs, in some instances, by limiting coverage, by limiting the amount of reimbursement for particular medications, or by encouraging the use of lower-cost generic products.

RISK FACTORS.

We cannot be sure that reimbursement will be available for any of the products that we develop and, if reimbursement is available, the level of reimbursement.

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Because each third-party payor individually approves payment or reimbursement, obtaining these approvals can be a time consuming and expensive process, requiring us to provide scientific or clinical support for the use of each of our products or product candidates separately to each third-party payor.

In some cases, it could take months or years before a particular private insurer or managed

RISK FACTORS.

care organization reviews a particular product.

In some cases, it could take months or years before a particular private insurer or managed care organization reviews a particular product.

Prior to that time, reimbursement may be negligible.

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In addition, many managed care organizations negotiate the reimbursement price of products through the use of formularies, which establish reimbursement levels.

Exclusion of a product from a formulary can lead to sharply reduced usage in the managed care organization's patient population because reimbursement is limited and/or negligible.

Exclusion of a product from a formulary, as has occurred in the past, can lead to sharply reduced usage in the managed care organization's patient population because reimbursement is limited and/or negligible.

If our products are not included within an adequate number of managed care formularies or reimbursed at adequate levels, or if those policies increasingly favor generic products, our market share and gross margins could be negatively affected.

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Congressional inquiries and proposed federal and state legislative initiatives designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under the Medicare program, to review the relationship between pricing and manufacturer patient programs, and to reform government reimbursement methodologies for drugs.

For additional information, see "Healthcare cost containment legislation and the failure of third-party payors to provide appropriate levels of coverage and reimbursement for the use of products and treatments facilitated by our products could harm our business and prospects." We expect to experience pricing pressures in connection with the sale of any of our products and product candidates due to the trend toward managed healthcare, the increasing influence of health maintenance organizations, additional cost containment initiatives, and additional legislative changes.

In some foreign jurisdictions, particularly Canada and Europe, the pricing of prescription pharmaceuticals is subject to strict governmental control.

" We expect to experience pricing pressures in connection with the sale of any of our products and product candidates due to the trend toward managed healthcare, the increasing influence of health maintenance organizations, additional cost containment initiatives, and additional legislative changes.

In some foreign jurisdictions, where certain of our products are sold by third parties pursuant to license agreements with us, particularly Canada and Europe, the pricing of prescription pharmaceuticals is subject to strict governmental control.

In these countries, pricing negotiations with governmental authorities can take 6 to 12 months, or longer, after the receipt of regulatory approval and product launch.

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If reimbursement for our products or product candidates is unavailable in any country in which reimbursement is sought or is limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be materially harmed and unprofitable.

As evidenced by the passage of the American Rescue Plan Act of 2021 and IRA of 2022, discussed in greater detail below, we expect these challenges to continue and to potentially intensify in 2024 and following years, as political pressures mount, and healthcare payors, including government-controlled health authorities, insurance companies, and managed care organizations, step up initiatives to reduce the overall cost of healthcare, restrict access to higher-priced new medicines, increase the use of generic products and impose overall price cuts.

As evidenced by the passage of the American Rescue Plan Act of 2021 and Inflation Reduction Act of 2022, discussed in greater detail below, we expect these challenges to continue and to potentially intensify during 2025, as political pressures mount, and healthcare payors, including government-controlled health authorities, insurance companies, and managed care organizations, step up initiatives to reduce the overall cost of healthcare, restrict access to higher-priced new medicines, increase the use of generic products and impose overall price cuts.

Such pressures could have a material adverse impact on our business, financial condition, and results of operations.

RISK FACTORS.

We depend on wholesalers, distributors, and specialty pharmacies for the distribution of our products.

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In addition, MYOBLOC is available for direct purchase by physicians and hospitals.

The majority of sales of APOKYN, GOCOVRI, and Osmolex ER are made to specialty pharmacies.

The majority of sales of GOCOVRI and APOKYN are made to specialty pharmacies.

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As a result, a small number of large wholesale distributors control a significant share of the market.

RISK FACTORS.

Consolidation of drug wholesalers has increased.

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Significant differences between actual and estimated inventory levels may result in excessive stocking, resulting in our holding substantial quantities of unsold inventory, or, alternatively, inadequate supplies of product in the distribution channels.

This could result in our inability to support sales at the retail level.

These changes may cause our revenues to fluctuate significantly from quarter to quarter and, in some cases, may cause our operating results for a particular quarter to be below our expectations, the expectations of securities analysts, and/or the expectations of investors.

This could result in an inability to support sales at the retail level.

These changes may cause our revenues to fluctuate significantly from quarter to quarter and, in some cases, may cause our operating results for a particular quarter to be below expectations.

At times, wholesalers and distributors may increase inventory levels in response to anticipated price increases, resulting in both greater wholesaler purchases prior to the anticipated price increase and in reduced wholesaler purchases in later quarters.

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Satisfaction of regulatory requirements typically takes many years, is dependent upon the type, complexity, and novelty of the product, and requires the expenditure of substantial resources.

We cannot predict whether or when we will obtain regulatory approval to commercialize our product candidates.

We cannot predict whether or when we will obtain regulatory

RISK FACTORS.

approval to commercialize our product candidates.

We cannot, therefore, predict the timing of any future revenues from these product candidates.

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• May find the clinical and other benefits of our product candidates do not outweigh their safety risks;

RISK FACTORS.

• May disagree with our trial design or our interpretation of data from preclinical studies, bioequivalence studies, and/or clinical trials, or may change the requirements for approval even after they have reviewed and commented on the design for our trials;

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If we fail to comply with these regulations, it could have a material adverse effect on our business and financial condition.

We intend to complete the development of an infusion-pump delivery system containing apomorphine (SPN-830).

We have previously submitted the NDA for SPN-830 to the FDA in September 2020 and received a refusal to file letter from the FDA.

We met with the FDA in March 2021 to clarify the steps required for the resubmission of the NDA for SPN-830.

We resubmitted the NDA for SPN-830 in December 2021 and we received FDA acceptance for review of NDA for SPN-830 during February 2022.

In October 2022, we received a Complete Response Letter ("CRL") from the FDA regarding the NDA for SPN-830 requesting additional information and analysis related to the infusion device and drug product across several areas of the NDA.

In October 2023, the Company resubmitted its NDA for SPN-830.

In November 2023, the FDA acknowledged it received the resubmitted NDA for SPN-830 and assigned PDUFA target action date in early April 2024.

RISK FACTORS.

In February 2025, the FDA approved ONAPGO (apomorphine hydrochloride) injection (formerly SPN-830), as the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced PD.

Business for further information.

We rely on and will continue to rely on outsourcing arrangements for certain of our critical activities, including clinical research of our product candidates, manufacture of our compounds and product candidates, and the manufacture of our commercial products.

If we fail to produce our products and product candidates in the volumes that we require on a timely basis or fail to comply with stringent regulations applicable to pharmaceutical drug manufacturers, we may face delays in the development and commercialization of our products and product candidates or be required to withdraw our products from the market.

RISK FACTORS.

We rely on outsourcing arrangements for some of our critical activities, including manufacturing, preclinical and clinical research, data collection and analysis, and electronic submission of regulatory filings.

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If any of these vendors are unable to perform their obligations to us, including due to violations of the FDA's requirements, our ability to meet regulatory requirements, projected timelines, and necessary quality standards for the development or commercialization of products would be adversely affected.

Further, if we were required to change vendors, it could result in substantial delays in our regulatory approval efforts, significantly increase our costs, and delay generation of revenues.

Further, if we were required to change suppliers, it could result in substantial delays in our regulatory approval efforts, significantly increase our costs, and delay generation of revenues.

Accordingly, the loss of any of our current or future third-party manufacturers or suppliers could have a material adverse effect on our business, results of operations, financial condition, and business prospects.

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At this time while we do not know of any geopolitical events impacting our supply chain, we cannot determine the impact of current or future geopolitical events which may ultimately have an impact on our supply chains or may create other unforeseen consequences affecting us or our suppliers.

Any future curtailment in the availability of raw materials or finished goods could result in production or other delays, with consequent adverse business effects.

Any future curtailment in the availability of raw materials or finished goods could result in production or other delays, resulting adverse business effects.

In addition, because regulatory authorities must generally approve raw material sources for pharmaceutical products, changes in raw material suppliers may result in production delays or higher raw material costs.

We may also encounter similar risks with the other products and product candidates where raw materials or finished goods are purchased from suppliers outside the U.S., as is the case for example for SPN-830, Qelbree, APOKYN, XADAGO, and MYOBLOC where various suppliers are based in Europe.

We may also encounter similar risks with the other products and product candidates where raw materials or finished goods are purchased from suppliers outside the U.S., as is the case for example for ONAPGO (formerly known as SPN-830), Qelbree, APOKYN, XADAGO, and MYOBLOC where various suppliers are based in Europe.

The manufacture of pharmaceutical products requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls.

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These problems can adversely affect production costs and yields, quality control, the stability of the product and quality assurance testing, as well as compliance with federal, state, and foreign regulations.

If we are unable to demonstrate stability in accordance with commercial requirements, or if our manufacturers were to encounter difficulties or otherwise fail to comply with their obligations to us, our ability to obtain or maintain FDA approval and to market our products and product candidates, respectively, would be jeopardized.

RISK FACTORS.

or maintain FDA approval and to market our products and product candidates, respectively, would be jeopardized.

In addition, any delay or interruption in producing clinical trial supplies could delay or prohibit the completion of our clinical trials, increase the costs associated with conducting our clinical trials and, depending upon the period of delay, require us to commence new trials at the significant additional expense or to terminate a trial.

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Failure to comply with these requirements may result in fines and civil penalties, suspension of production, suspension or delay in product approval, product seizure or recall, or withdrawal of product approval.

If the safety of any of our products or product candidates is compromised due to failure to adhere to applicable laws or for other reasons, we may not be able to obtain regulatory approval for such product candidates or

RISK FACTORS.

to successfully commercialize such products.

We may be held liable for any injuries sustained as a result.

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Although protection under the Hatch-Waxman Amendments will not prevent the submission or approval of another full NDA, such an NDA applicant would be required to conduct its own preclinical and adequate, well-controlled clinical trials to demonstrate safety and effectiveness.

Currently, the Company has a five-year and seven-year marketing exclusivity period for Qelbree and GOCOVRI, respectively.

Currently, the Company has a five-year marketing exclusivity period for Qelbree.

If we are unable to obtain marketing exclusivity for our subsequent product candidates, then our competitors may obtain approval for competing products more easily than if we had such marketing exclusivity.

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Companies that produce generic equivalents are generally able to offer their products at significantly lower prices.

Thus, regardless of the regulatory approval pathway, after the introduction of a generic competitor, a significant percentage of the sales of any branded product are typically lost to the generic product through both price and volume erosion.

Accordingly, competition from generic equivalents would adversely, materially, and permanently impact our revenues, profitability, and cash flows from those products.

In this eventuality, it would substantially limit our ability to obtain a return on the investments we have made in our products and product candidates.

RISK FACTORS.

both price and volume erosion.

Accordingly, as we have observed with Trokendi XR and Oxtellar XR, competition from generic equivalents adversely, materially, and permanently impact our revenues, profitability, and cash flows from those products and may substantially limit our ability to obtain a return on the investments we have made in our products.

If our competitors develop or market alternatives for the treatment of our target indications, our commercial opportunities will be reduced or eliminated.

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These include large pharmaceutical companies, smaller pharmaceutical companies, biotechnology companies, academic institutions, government agencies, and private and public research institutions.

RISK FACTORS.

The availability of new products or the approval of new indications for existing products may limit the demand for and the price we are able to charge for any of our products.

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In addition to competition for our current commercial products, we anticipate that we will face intense competition when our pipeline product candidates are approved by regulatory authorities and begin their commercialization process.

In particular, we are aware of Serina Therapeutics and AbbVie developing product candidates that may compete with SPN-830.

In particular, we are aware of Serina Therapeutics developing a product candidate that may compete with ONAPGO (formerly SPN-830).

Also, AbbVie has developed and received FDA approval in October 2024 to market a subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of motor fluctuations in adults with advanced Parkinson disease (PD).

New developments, including the development of other drug technologies, may render our products or product candidates obsolete or noncompetitive.

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regulatory approval has been obtained for our products, the FDA may impose significant restrictions on their indicated uses, or may impose restrictions on marketing, or may impose requirements for costly post-approval studies.

For example, certain of our products, including Qelbree, Trokendi XR, Oxtellar XR and MYOBLOC, were approved on the basis of post-approval commitments.

We received approval for Qelbree from the FDA, based on certain post-marketing commitments, including the requirement to conduct a clinical efficacy and six month open label safety extension study for ADHD in pediatric patients 4 to 5 years of age, a lactation study and a descriptive study related to the use of Qelbree during pregnancy, and to assess the risks of adverse events and potential complications.

We are working toward meeting these post-marketing commitments for Qelbree in a timely manner.

We have post-marketing commitments for Trokendi XR, Oxtellar XR, and MYOBLOC.

For example, certain of our products, including Qelbree, ONAPGO, Oxtellar XR, Trokendi XR, and MYOBLOC, were approved on the basis of post-approval commitments.

We have post-marketing commitments for Qelbree including the requirement to conduct a clinical efficacy and six month open label safety extension study for ADHD in pediatric patients 4 to 5 years of age, a lactation study and a descriptive study related to the use of Qelbree during pregnancy, and to assess the risks of adverse events and potential complications.

RISK FACTORS.

working toward meeting these post-marketing commitments for Qelbree in a timely manner.

We also have post-marketing commitment to conduct a new leachable study for ONAPGO, which was approved by the FDA in February 2025.

We also have post-marketing commitments for Oxtellar XR and MYOBLOC.

Although we have initiated work on some of these post-marketing commitments, we have not been able to accomplish them.

We were released from the majority of our post-marketing commitments for Trokendi XR in 2024.

If we do not meet our post-marketing commitments and are unable to show good cause for our inability to adhere to the timetables laid out in the approval letters, the FDA could take enforcement action against us, including withdrawal of approval.

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In addition, manufacturers of drug products and their facilities are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with current good manufacturing practice (cGMP) regulations.

If we, our collaborators, or a regulatory authority discover previously unknown problems with a product, including

RISK FACTORS.

side effects that are unanticipated in severity or frequency, or problems with the facility where the product is manufactured, a regulatory authority may impose restrictions on that product or on the manufacturer, including requiring withdrawal of the product from the market or suspension of manufacturing.

If we, our collaborators, or a regulatory authority discover previously unknown problems with a product, including side effects that are unanticipated in severity or frequency, or problems with the facility where the product is manufactured, a regulatory authority may impose restrictions on that product or on the manufacturer, including requiring withdrawal of the product from the market or suspension of manufacturing.

If we or our collaborators, or our products, product candidates, or our collaborators' products, or the manufacturing facilities for our products, product candidates or our collaborators' products fail to comply with applicable regulatory requirements, a regulatory authority may:

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If we are unable to adapt on a timely basis, or at all, to changes in existing requirements or to adopt new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we have obtained, adversely affecting our business, prospects, and ability to achieve or sustain profitability.

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We depend on collaborators to work with us to develop, manufacture and commercialize their and our products and product candidates.

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These CMOs offer a comprehensive range of contract manufacturing services.

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We have a license agreement with United Therapeutics Corporation to use one of our proprietary technologies in an oral formulation of treprostinil diethanolamine, or treprostinil, for the treatment of pulmonary arterial hypertension and for other indications.

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• Change the focus of their development and commercialization efforts, or may have insufficient resources to effectively develop our product candidates;

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• Pharmaceutical and biotechnology companies historically have re-evaluated their development and commercialization priorities following mergers and consolidations, which have been common in recent years.

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• Breach or terminate their arrangement with us.

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If collaboration partners fail to develop or fail to effectively commercialize our products for any of these reasons, we may not be able to replace the collaboration partner with another partner to develop and commercialize the product under the terms of the collaboration, if at all.

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The product candidates to which we allocate our resources, even if approved, may not be commercially successful.

In addition, because our internal research capabilities are limited, we may be dependent upon pharmaceutical companies, academic scientists, and other researchers to sell or license products or technologies to us.

In addition, because our internal research capabilities are limited, we may be dependent upon pharmaceutical companies, academic scientists, and other researchers to sell or license

RISK FACTORS.

products or technologies to us.

The success of this strategy depends partly upon our ability to identify, select, discover and acquire promising pharmaceutical product candidates and approved products, and to manage our spending as expenses related to undertaking clinical trials can be substantial.

In September 2020, we submitted the NDA for SPN-830 to the FDA.

In November 2020, we received a Refusal to File (RTF) letter from the FDA regarding the NDA in which the FDA determined that the NDA was not sufficiently complete to permit a substantive review.

In the letter, the FDA requested certain documents and reports to be submitted in support of the NDA.

In March 2021, we met with the FDA to discuss the path forward for resubmission of the SPN-830 NDA.

The FDA provided additional clarity related to the contents of the RTF letter and the requirements for resubmission and in December 2021, the Company resubmitted the SPN-830 NDA to the FDA.

In February 2022, the Company received notice from the FDA that the company’s New Drug Application (NDA) resubmission for its apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations ("off" episodes) in Parkinson's Disease is considered a Standard Review thereby assigning a timeline of 10 months for review by the FDA and establishing a Prescription Drug User Fee Act (PDUFA) target action date in early October, 2022.

In October 2022 we received a CRL from the FDA regarding the NDA for SPN-830 requesting additional information and analysis related to the infusion device and drug product across several areas of the NDA.

In October 2023, the Company resubmitted its NDA for SPN-830.

In November 2023, the FDA acknowledged it received the resubmitted NDA for SPN-830 and assigned a PDUFA target action date in early April 2024.

In February 2025, the FDA approved ONAPGO (apomorphine hydrochloride) injection, formerly known as SPN-830, as the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced PD.

We may be unable to acquire product candidates or products.

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Other companies, including some with substantially greater financial, marketing and sales resources, may compete with us for the license, the product candidate, or approved product.

We have limited resources, including

RISK FACTORS.

financial resources, to identify and execute the acquisition or in-licensing of third-party products, businesses, and technologies and integrate them into our current infrastructure.

We have limited resources, including financial resources, to identify and execute the acquisition or in-licensing of third-party products, businesses, and technologies and integrate them into our current infrastructure.

Moreover, we may devote significant resources to potential acquisitions, or in-licensing opportunities wherein those transactions are never consummated, or we may fail to realize the anticipated benefits of such efforts.

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If our product candidates are not shown to be safe and effective, these clinical development programs might be terminated.

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Delays or failures in the completion of clinical development of our product candidates would increase our costs, delay, or limit our ability to generate revenues.

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• Insufficient or inadequate supply of or quantity of a product candidate for use in trials;

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• Challenges recruiting and enrolling patients to participate in clinical trials, for any and all reasons, including competition from other programs for the treatment of similar conditions;

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This could result in the denial of regulatory approval by the FDA or other regulatory authorities and result in potential product liability claims.

Undesirable side effects caused by any of our products could cause regulatory authorities to temporarily or permanently halt product sales, which could have a material adverse effect on our business.

Undesirable side effects caused by any of our products could cause regulatory

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authorities to temporarily or permanently halt product sales, which could have a material adverse effect on our business.

As required by the FDA, the labels for our products include precautions and warnings about side effects, and in certain cases, the need for monitoring patients receiving the product.

If our products cause side effects, or if any of our product candidates receive marketing approval, and we or others later identify undesirable side effects caused by our products or product candidates, a number of potentially significant negative consequences could result, including, among others:

If our products cause side effects, and we or others later identify undesirable side effects caused by our products or product candidates, a number of potentially significant negative consequences could result, including, among others:

• regulatory authorities may withdraw approval of the product or otherwise require us to take the approved product off the market;

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• we may be required to create a medication guide outlining the proper use of the medication and the risks of side effects for distribution to patients;

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• we may be required to modify the product in some way;

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Exceptions are limited, such as showing clinical superiority over the drug with orphan drug exclusivity.

GOCOVRI has been granted orphan drug exclusivity until August 24, 2024 for the treatment of dyskinesia in patients with Parkinson’s Disease receiving levodopa-based therapy with or without concomitant dopaminergic medications.

Although we have been granted FDA orphan drug designation for SPN-817 for the treatment of Dravet Syndrome and Lennox-Gaustaut Syndrome, and we intend to expand our designation for alternative uses where applicable, we may not receive the benefits associated with orphan drug designation.

Although we have been granted FDA Orphan Drug Designation for SPN-817 for the treatment of Dravet Syndrome and Lennox-Gaustaut Syndrome and for ONAPGO for the treatment of motor fluctuations in adults with advanced PD, and we intend to expand our designation for alternative uses where applicable, we may not receive the benefits associated with Orphan Drug Designation.

This may result from a failure to maintain orphan drug status, or it may result from a competing product reaching the market with an orphan designation for the same disease indication.

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We do not know if, when, or how the FDA may change the orphan drug regulations and policies in the future.

It is uncertain how any changes might affect our business.

It is uncertain how

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any changes might affect our business.

Depending on what changes the FDA may make to its orphan drug regulations and policies, our business could be adversely impacted.

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The continuing efforts of third-party payors, including U.S.

federal and state agencies, foreign governments, insurance companies, managed care organizations, employers, and other payors of healthcare services to contain or reduce

RISK FACTORS.

healthcare costs may adversely affect the Company's ability to set prices at launch, increase prices after launch, generate revenues, achieve profitability, and/or maintain profitability.

federal and state agencies, foreign governments, insurance companies, managed care organizations, employers, and other payors of healthcare services to contain or reduce healthcare costs may adversely affect the Company's ability to set prices at launch, increase prices after launch, generate revenues, achieve profitability, and/or maintain profitability.

In addition to healthcare reform initiatives in the U.S.

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These laws and their regulations (collectively "HealthCare Reform Law") have far reaching consequences for pharmaceutical companies like the Company.

Possible revisions to the HealthCare Reform Law are the subject of ongoing legislative debates and litigation.

Possible revisions to the HealthCare Reform Law are the subject of continuing legislative debates and litigation.

The HealthCare Reform Law exerts downward pressure on pharmaceutical pricing, especially under the Medicare and Medicaid programs, and has increased the industry's regulatory burden and operating costs.

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• An increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program;

• Rebates owed by manufacturers under the Medicaid Drug Rebate Program for drugs that are inhaled, infused, instilled, implanted, or injected.

On December 21, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule that makes significant modifications to the Medicaid Drug Rebate Program regulations in several areas, including with respect to the treatment of value-based purchasing arrangements, the definition of key terms, and the price reporting treatment of manufacturer-sponsored patient benefit programs;

• Rebates owed by manufacturers under the Medicaid Drug Rebate Program (MDRP) for drugs that are inhaled, infused, instilled, implanted, or injected.

During 2020, the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule that makes significant modifications to the Medicaid Drug Rebate Program regulations in several areas, including with respect to the treatment of value-based purchasing arrangements, the definition of key terms, and the price reporting treatment of manufacturer-sponsored patient benefit programs.

On May 26, 2023, CMS issued a proposed rule seeking to implement policies in the MDRP related to the new legislative requirements in the Medicaid Services Investment and Accountability Act of 2019 to address, among other things, drug misclassification and drug pricing and product data misreporting by manufacturers

• A Medicare Part D coverage gap discount program, in which manufacturers must agree to offer a substantial point-of-sale discount off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer's outpatient drugs to be covered under Medicare Part D;

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• A requirement to annually report the number of drug samples that manufacturers and distributors provide to physicians;

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• A Patient-Centered Outcomes Research Institute to oversee, identify priorities for, and conduct comparative clinical effectiveness research, and provide funding for such research.

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These rebates function as a discount off the list price and eliminating the cap means that manufacturer discounts paid to Medicaid can increase.

Prior to this change, manufacturers have not been required to pay more than 100% of the Average Manufacturer Price (“AMP”) in rebates to state Medicaid programs for Medicaid-covered drugs.

As a result of this provision, beginning in 2024 it is possible that manufacturers may have to pay state Medicaid programs more in rebates than they receive on sales of particular products.

Prior to this change, manufacturers had not been required to pay more than 100% of the Average Manufacturer Price (“AMP”) in rebates to state Medicaid programs for Medicaid-covered drugs.

As a result of this provision, effective January 1, 2024 manufacturers may have to pay state Medicaid programs more in rebates than they receive on sales of particular products.

This change could present a risk to the Company in the future for drugs that have high Medicaid utilization and rebate exposure that is more than 100% of the AMP.

ARPA may push certain pharmaceutical manufacturers to reconsider pricing strategies and overall business in Medicaid and other federal programs.

RISK FACTORS.

As a result of ARPA certain pharmaceutical manufacturers may reconsider pricing strategies and overall business in Medicaid and other federal programs.

In 2022 the IRA was enacted, which made significant changes to how drugs are covered and paid for under the Medicare program, including the creation of financial penalties for drugs whose prices rise faster than the rate of inflation, redesign of the Medicare Part D program to require manufacturers to bear more of the liability for certain drug benefits, and government price-setting for certain Medicare Part D drugs, starting in 2026, and Medicare Part B drugs starting in 2028.

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Prior to the U.S.

Supreme Court ruling, President Biden issued an executive order instructing certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including, among others, re-examining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create barriers to obtaining access to health insurance coverage through Medicaid or the HealthCare Reform Law.

Supreme Court ruling, then President Biden issued an executive order instructing certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including, among others, re-examining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create barriers to obtaining access to health insurance coverage through Medicaid or the HealthCare Reform Law.

On June 28, 2024, the Supreme Court overruled their landmark 1984 decision in Chevron v.

Natural Resources Defense Council, which gave rise to the doctrine known as the Chevron doctrine.

The Supreme Court’s ruling sharply reduced the power of federal agencies to interpret the laws they administer and ruled that courts should rely on their own interpretation of ambiguous laws.

This ruling could have a significant impact on the health care industry, which is heavily regulated by multiple federal agencies and subject to frequent federal rulemaking regarding such topics as reimbursement, health care operations, patient safety, and patient privacy.

There was enormous growth and visibility for artificial intelligence (AI) systems and tools in 2023, leading to increased calls for regulation and oversight.

On October 30, 2023, the Biden Administration issued an Executive Order on the Safe, Secure, and Trustworthy Development and Use of AI, which addressed the use of AI in health care and the safety and integrity of data stored and generated by AI health care technology systems and directed HHS to establish an AI Task Force that must, within 365 days of its creation, develop policies and specific frameworks addressing the use of AI and AI -enabled technologies in the health sector, including research, drug and device safety, and health care delivery and financing.

Congress may consider other legislation to repeal or replace elements of the HealthCare Reform Law.

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FDA statutes, regulations, and guidance often are revised or reinterpreted by the FDA in ways that may significantly affect the Company's business and products.

The FDA Reauthorization Act of 2017 (FDARA) amended the FDCA to revise and extend the user-fee programs for drugs, medical devices, generic drugs, and biosimilar biological products, and for other programs.

FDARA reauthorized the various user fees to facilitate the FDA's review and oversight relating to prescription drugs, generic drugs, medical devices, and biosimilars.

FDA's authority, including, among others, pediatric study requirements, orphan drug exclusivity, and the approval process for generic drugs.

The FDA also has enhanced its post-marketing authority, including the authority to require post-marketing studies and clinical trials, make labeling changes based on new safety information, or to require compliance with risk evaluation and mitigation strategies.

The 2012 Food and Drug Administration Safety and Innovation Act expanded drug supply chain reporting requirements and strengthened the FDA's response to drug shortages.

The FDA's exercise of its authority could result in delays or increase costs during product development and regulatory review.

It could also result in increased costs to assure compliance with post-approval regulatory requirements and potential restrictions on the sale and/or distribution of any approved product.

It is impossible to predict whether additional legislative changes will be enacted or whether FDA regulations, guidance, or interpretations will be changed, and what the impact of such changes, if any, may be.

Future regulatory changes could make it more difficult for the Company to maintain or attain approval to develop and commercialize its products and technologies.

Healthcare cost containment legislation and the failure of third-party payors to provide appropriate levels of coverage and reimbursement for the use of products and treatments facilitated by our products could harm our business and prospects.

The Company's products are dependent on the coverage decisions and reimbursement policies established by government healthcare programs and private health insurers.

These policies affect which products customers purchase and the prices customers are willing to pay.

Reimbursement varies by country and can significantly impact the acceptance of new products and technologies.

Even if the Company develops a promising new product, there may be limited demand for the product unless appropriate reimbursement approval is obtained from private and governmental third-party payors.

Additional legislative or administrative reforms to the reimbursement systems in the U.S.

and other countries that significantly reduce reimbursement for the Company's products, including price regulation, competitive bidding and tendering, coverage and payment policies,

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