What changed in this filing

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Item 1. Business

2026-03-02 compared with 2025-02-25 · 459 added, 270 removed, 1142 unchanged (39% 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.

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'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, postpartum depression (PPD), epilepsy, migraine, cervical dystonia, and chronic sialorrhea.

The Company is developing a broad range of novel product candidates for 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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then upon our acquisition of substantially all of the assets of Shire Laboratories, Inc.

in 2005, as Supernus Pharmaceuticals.

in 2005, as Supernus Pharmaceuticals, Inc.

Acquisition of Sage Therapeutics, Inc.

and Reorganization

On June 13, 2025, the Company entered into a Merger Agreement to acquire Sage Therapeutics, Inc (Sage).

Under the terms of the Merger Agreement, the Company commenced a tender offer to acquire all outstanding shares of Sage, par value $0.001 per share (the Shares and each, a Share), at an offer price of (i) $8.50 per share in cash, less any applicable withholding taxes and without interest (the Cash Amount;

an aggregate of approximately $561 million paid as of the acquisition date), plus (ii) one contingent value right per Share (the CVR;

an aggregate of approximately $234 million, subject to the achievement of

specific contingencies), which represents the right to receive up to $3.50 and is governed by the terms of a contingent value rights agreement entered into between the Company and the CVR agent (the CVR Agreement).

Any amount payable pursuant to the CVRs is payable, in cash, less any applicable withholding taxes and without interest (the Cash Amount plus the CVR, collectively;

or any higher amount per Share paid pursuant to the Offer, the Offer Price).

Subject to the terms of the CVR Agreement, (1) $1.00 per share would be payable if in any calendar year between closing and end of 2027, annual net sales (as defined in the CVR Agreement) of ZURZUVAE allocable to Supernus or any of its affiliates reach $250 million or more in the U.S., (2) $1.00 per share would be payable if in any calendar year between closing and end of 2028, annual net sales (as defined in the CVR Agreement) of ZURZUVAE allocable to Supernus or any of its affiliates reach $300 million or more in the U.S., (3) $1.00 per share would be payable if in any calendar year between closing and end of 2030, annual net sales (as defined in the CVR Agreement) of ZURZUVAE allocable to Supernus or any of its affiliates reach $375 million or more in the U.S., and (4) $0.50 per share would be payable upon the first commercial sale in Japan to a third-party customer after regulatory approval for ZURZUVAE for the treatment of major depressive disorder (MDD) in Japan by June 30, 2026.

The maximum amount payable with respect to a CVR issued in respect to each Share is $3.50.

The transaction closed and the Company completed the acquisition of Sage on July 31, 2025.

Following the Sage Acquisition, during the third quarter of 2025, Sage Therapeutics, Inc.

was reorganized into Sage Therapeutics, LLC.

Our mission is to improve the lives of patients suffering from CNS diseases.

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• Advance product candidates toward commercialization.

Several product candidates in our pipeline are in early-to-late stage clinical testing, and moving toward being commercially available to patients.

Several product candidates are in various stages of development.

• Continue to grow our pipeline.

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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.

GOCOVRI (amantadine) extended-release capsules are 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.

GOCOVRI was approved by the FDA in August 2017 for treatment of dyskinesia and in February 2021 as an adjunctive treatment for "OFF" episodes.

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.

Oxtellar XR ®

Oxtellar XR is indicated for treatment of partial-onset seizure in adults and children 6 years of age and older.

Oxtellar XR is the first once-daily extended-release oxcarbazepine product indicated for the treatment of epilepsy in the U.S.

In 2013, we launched Oxtellar XR for adjunctive therapy in the treatment of partial-onset seizures in adults and children 6 to 17 years of age.

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 agreements with third parties permitting the sale of a generic version of GOCOVRI beginning in June 2029, or sooner under certain conditions.

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.

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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.

Oxtellar XR ®

Oxtellar XR is indicated for treatment of partial-onset seizure in adults and children 6 years of age and older.

Oxtellar XR is the first once-daily extended-release oxcarbazepine product indicated for the treatment of epilepsy in the U.S.

In 2013, we launched Oxtellar XR for adjunctive therapy in the treatment of partial-onset seizures in adults and children 6 to 17 years of age.

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.

ZURZUVAE ® capsules are the first and only FDA approved oral medicine indicated for the treatment of PPD in adults.

ZURZUVAE is a neuroactive steroid that is a positive allosteric modulator of GABA A receptors, targeting both synaptic and extrasynaptic GABA A receptors, and is the first oral, once-daily, 14-day treatment specifically indicated for adults with PPD.

ZURZUVAE became commercially available in the U.S.

in December 2023 as a treatment option for women with PPD.

We and our collaboration partner, Biogen MA Inc.

(BIMA) and Biogen International GmbH (together with BIMA, Biogen), are jointly commercializing ZURZUVAE in the U.S.

under a collaboration agreement (Biogen Collaboration Agreement).

The Company and Biogen equally share in all operating profits and losses arising from sales of ZURZUVAE in the U.S., with Biogen recording such product sales.

Biogen has the right to commercialize ZURZUVAE outside of the United States, other than in Japan, South Korea, and Taiwan (the Shionogi Territory).

In the third quarter of 2025, Biogen received approval for zuranolone for the treatment of PPD by the European Medicines Agency (EMA) and Medicines Healthcare Regulatory Agency (MHRA) in Europe and the United Kingdom (U.K.) respectively.

In the fourth quarter of 2025, ZURZUVAE received Health Canada Authorization in Canada for treatment indicated for adults with PPD.

Pursuant to a collaboration agreement with Shionogi for the development of products containing zuranolone in the Shionogi Territory.

Shionogi is currently developing a product containing zuranolone for the treatment of patients with major depressive disorder, or MDD, in Japan.

No product containing zuranolone is approved for the treatment of MDD in the United States.

In the third quarter of 2024, Shionogi reported that it submitted a new drug application, or NDA, in Japan for a product containing zuranolone for the treatment of MDD.

In the fourth quarter of 2025, Shionogi received approval from the Pharmaceuticals and Medical Devices Agency for the manufacturing and marketing of a product containing zuranolone in Japan for the treatment of MDD.

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.

ONAPGO was launched in April 2025.

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.

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

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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 represents a novel mechanism of action (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 has received Orphan Drug Designation for both Dravet Syndrome and Lennox-Gastaut Syndrome from the FDA.

We are focused on completing and optimizing the synthesis process of the synthetic drug as well as developing a novel dosage form.

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 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.

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 in clinical development.

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 is a novel, first in class, intracellular enhancer of mechanistic target of rapamycin complex 1 (mTORC1) signaling.

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 potential 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 intracellular mechanism and the lack of binding to cell surface receptors suggests the potential for a differentiated safety profile and is unlikely to have abuse potential.

In February 2025, the Company reported topline results from a randomized double-blind placebo-controlled Phase 2b study of SPN-820 in adults with treatment-resistant depression (TRD) following four weeks of chronic daily dosing.

The study did not demonstrate a statistically significant improvement on the primary and 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.

The Company initiated a follow-on Phase 2b multi-center, randomized, double-blind, placebo-controlled trial in approximately 200 adults with MDD.

The study will examine the safety and tolerability of SPN-820 2400 mg given intermittently (twice weekly) as an adjunctive treatment to the current baseline antidepressant therapy, as well as assess the rapid onset of improvement in depressive symptoms.

For drugs that work through the mTROC1 pathway, emerging data indicate that chronic daily dosing may actively suppress sustained neuroplasticity and antidepressant benefits.

Accordingly, the follow-on Phase 2b study will utilize intermittent dosing consistent with what was used in a Phase 2a open label study that showed a potential clinical effect of SPN-820.

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

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

The Company 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.

The primary objective of the study was to assess 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.

The Company has selected ADHD as the lead indication for SPN-443 and plans to initiate single-ascending dose (SAD) and multiple-ascending dose (MAD) studies in the second half of 2026.

The Company has granted Biogen sole rights to develop and commercialize zuranolone outside the U.S., other than in Japan, Taiwan and South Korea where it has granted those rights to Shionogi & Co., Ltd.

Shionogi is currently developing zuranolone for the treatment of patients with MDD in Japan, and in the third quarter of 2024, Shionogi reported that it submitted a new drug application (NDA) in Japan for zuranolone for the treatment of MDD.

No product containing zuranolone is approved for the treatment of MDD in the United States.

In the fourth quarter of 2025, Biogen received Health Canada Authorization for zuranolone for the treatment of PPD in Canada.

In the fourth quarter of 2025, Shionogi received approval for a product containing zuranolone for the treatment of MDD by the Pharmaceuticals and Medical Devices Agency in Japan.

Sales and Marketing

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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.

One sales force focuses on 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.

Another sales force focuses on psychiatrists, pediatricians, primary care physicians, and advanced practice providers in the ADHD area.

A third sales force focuses on psychiatrists, obstetricians-gynecologists, and other health professionals in the postpartum depression 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 Qelbree, Oxtellar XR, Trokendi XR, and XADAGO are made to wholesalers and distributors.

The majority of sales of Qelbree, Oxtellar XR, Trok endi 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 GOCOVRI and APOKYN, are made to specialty pharmacies.

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

Each of our three major customers, Cencora, Inc., Cardinal Health, Inc., and McKesson Corporation, individually accounted for more than 15% of our total product revenue in 2025 and collectively accounted for more than 76% of our total product revenue in 2025.

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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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Competition in the U.S.

ADHD market has increased with the commercial launch of several branded products in recent years, as well as the launch of generic versions of branded drugs, such as Adderall XR, Concerta, Vyvanse, Intuniv, Kapvay and Strattera.

We expect competition in this market to increase as new products are developed.

For example, in the fourth quarter of 2025, an NDA was filed with the FDA for centanafadine for the treatment of ADHD and was accepted for priority review in Q1 2026.

Treatment options for ADHD in the U.S.

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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.

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.

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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.

APOKYN also competes with other products for the treatment of PD, both branded such as VYALEV and Crexont, and generics, 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.

The FDA approved ONAPGO in February 2025, and the Company launched 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.

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.

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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.

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

Postpartum Depression

Postpartum depression symptoms are some of the most common medical complications during and after pregnancy, and PPD is characterized by depressive symptoms that can begin during pregnancy or within the first four weeks to twelve months following childbirth.

PPD symptoms may include sadness and depressed mood;

anxiety or agitation;

loss of interest in daily activities;

changes in eating and sleeping habits;

feeling overwhelmed;

fatigue and decreased energy;

inability to concentrate;

hypervigilance about the baby or lack of interest in the baby;

and feelings of worthlessness, shame or guilt.

Z URZUVAE is a neuroactive steroid that is a positive allosteric modulator of GABAA receptors, targeting both synaptic and extrasynaptic GABAA receptors, and is the first oral, once-daily, 14-day treatment specifically indicated for adults with PPD.

ZURZUVAE became commercially available in the U.S.

for women with PPD in December 2023.

We and our collaboration partner, Biogen, are jointly commercializing ZURZUVAE in the U.S.

under the Biogen Collaboration Agreement.

We and Biogen equally share in all operating profits and losses arising from sales of ZURZUVAE in the U.S., with Biogen recording such product sales.

ZU RZUVAE received a Schedule IV classification from the Drug Enforcement Administration, or DEA.

The approval of ZURZUVAE to treat PPD in adults was based on two pivotal clinical trials in adult women with PPD.

ZURZUVAE includes a boxed warning that instructs healthcare professionals to advise patients that ZURZUVAE causes driving impairment due to central nervous system depressant effects, and that people who take ZURZUVAE should not drive a motor vehicle or engage in other potentially hazardous activities requiring complete mental alertness until at least 12 hours after ZURZUVAE administration for the duration of the 14-day treatment course.

ZURZUVAE can cause CNS depressant effects.

The most common side effects of ZURZUVAE include sleepiness or drowsiness, dizziness, common cold, diarrhea, feeling tired, weak, or having no energy, and urinary tract infection.

ZURZUVA E currently competes with the current standard of care for PPD, which commonly consists of psychotherapy;

however, patients with moderate or severe PPD are often prescribed antidepressant medications such as SSRIs and SNRIs.

ZURZUVAE may also face competition from drugs currently in development, if successfully developed and approved in the future for the treatment of PPD, including potentially LPCN 1154, an oral formulation of the neuroactive steroid brexanolone under development by Lipocine, Inc.

under the streamlined 505(b)(2) regulatory pathway, which allows for approval of an abbreviated NDA by the FDA, and BRII-296, an intramuscular formulation of brexanolone being developed by Brii Biosciences, and RE104 which is being developed by Reunion Neuroscience.

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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Manufacturing

We currently depend on third-party commercial manufacturing organizations (CMOs) for all manufa cturing operations, including the production of raw materials, dosage form product, and product packaging.

We currently depend on third-party contract manufacturing organizations (CMOs) for all manufa cturing operations, including the production of raw materials, dosage form product, and product packaging.

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

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(a subsidiary of Thermo Fisher Scientific Inc.), Packaging Coordinators, Inc., Aphena Pharma Solutions, and Catalent Pharma Solutions, Europe, and Asia for the manufacturing and packaging of some of our commercial products, including those of our subsidiaries, as well as for our pipeline product candidates.

For Qelbree, Trokendi XR, GOCOVRI, and Oxtellar XR we currently rely on third-party CMOs for the manufacturing and packaging of final commercial products.

For Qelbree, Trokendi XR, GOCOVRI, Oxtellar XR, and ZURZUVAE, we currently rely on third-party CMOs for the manufacturing and packaging of final commercial products.

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 ZURZUVAE, we source raw materials from Asia and manufacture ZURZUVAE in Europe.

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

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MYOBLOC is manufactured and packaged in Europe by Merz GmbH & Co.

Under the contract manufacturing agreement with Merz for the manufacture and supply of MYOBLOC, the Company has an annual minimum purchase requirement of MYOBLOC amounting to an estimated €3.9 million.

In October 2021, we entered into an amendment to the Merz Agreement which increased the price of the annual purchase commitment of MYOBLOC from €3.0 million to approximately €3.9 million.

An amendment to the contract manufacturing agreement with Merz was executed in July 2025.

Amendments to the contract manufacturing agreement included among other things, the removal of the annual minimum purchase requirement of MYOBLOC, and the Company's agreement to pay a nonrefundable annual fee of €3.0 million to cover general maintenance and reservation costs for the manufacturing facilities.

For further discussion on the embedded operating lease related to the Merz Agreement, refer to Note 13, Leases in the Notes to the Consolidated Financial Statements in Part II, Item 8 of this report.

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

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These technologies have been utilized to create novel, customized product profiles designed to enhance efficacy, reduce the frequency of dosing to improve patient adherence and improve tolerability.

Our technologies have been used to create ten commercial products, including our products:

Qelbree, Trokendi XR and Oxtellar XR;

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

Our tec hnologies have been used to create eleven commercial products, including our products:

Qelbree, Trokendi XR, Oxtellar XR, and ONAPGO;

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

Intuniv (developed for Shire);

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We are also engaged in generating and assessing New Chemical Entities (NCEs).

These NCEs are generated by leveraging our expertise in structure function relationships in active molecules.

These NCEs are generated by leveraging our expertise in structure function relationships in active molecules and medicinal chemistry.

Our NCEs are being assessed in preclinical pharmacology models for CNS activity and are advancing towards Investigational New Drug application (IND) enabling toxicology studies to support potential future clinical investigation.

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Patent Portfolio

Our commercial products, including those of our subsidiaries, covered by active patents include Trokendi XR, Oxtellar XR, Qelbree, GOCOVRI, Osmolex ER and XADAGO.

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 Qelbree and GOCOVRI.

Our commercial products, including those of our subsidiaries, covered by active patents include Trokendi XR, Oxtellar XR, Qelbree, GOCOVRI, Osmolex ER, XADAGO, and ZURZUVAE.

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

patent applications for Qelbree.

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

patents that cover XADAGO.

The Company has ongoing patent litigation concerning Trokendi XR.

The Company has ongoing patent litigation concerning Qelbree.

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.

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.

There are 13 U.S.

patents that cover GOCOVRI.

The issued patents expire from 2028 to 2038.

These patents 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.

patents, 11 of which cover Oxtellar XR.

The 11 issued U.S.

patents covering Oxtellar XR will expire no earlier than 2027.

We own all of the issued patents and the pending U.S.

There are 11 U.S.

patents that cover Oxtellar XR.

These patents will expire no earlier than 2027.

We own all the issued patents and the pending U.S.

patent applications.

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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.

There are 10 U.S.

patents that cover Trokendi XR.

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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 XADAGO has 3 U.S.

patents licensed from Zambon.

These patents will expire from 2027 to 2031.

There are 3 U.S.

patents covering XADAGO.

These patents were licensed from Zambon and will expire from 2027 to 2031.

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.

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.

In February 2025, ONAPGO was approved by the FDA, and was launched in April 2025.

There are 5 U.S.

patents covering ZURZUVAE.

These patents will expire from 2034 to 2037, subject to any patent term extensions.

We also have patents issued in Japan and Europe and pending applications in the U.S.

and certain other foreign countries.

These patents are owned by Sage Therapeutics, LLC, and are licensed to Supernus Pharmaceuticals, Inc.

SPN-817 (huperzine A)

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 have two patents 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.

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intellectual property laws:

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

"Supernus ® ", "Microtrol ® ", "Qelbree ® ", "GOCOVRI ® ", "Oxtellar XR ® ", "APOKYN ® ", "Trokendi XR ® ", "XADAGO ® ", "MYOBLOC ® ", "Osmolex ER ® ", "Namzaric ® ", "ONAPGO TM ", "ZURZUVAE ® ", 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.

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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 .

ZURZUVAE (SAGE-217)

In July 2025, we acquired Sage Therapeutics.

Through this acquisition, we obtained a collaboration and licensing agreement with Biogen Inc.

for the development, manufacture and commercialization of ZURZUVAE and additional products containing zuranolone, which, along with ZURZUVAE, we refer to as Licensed Zuranolone Products.

Under the Biogen Collaboration Agreement, we and Biogen agreed that we will jointly develop and commercialize the Licensed Zuranolone Products in the U.S., and that Biogen solely will develop and commercialize the Licensed Zuranolone Products in territories outside the U.S.

other than Japan, the Republic of Korea, and Taiwan (the Biogen Territory).

We and Biogen have agreed to share jointly in the performance of the activities under the Biogen Collaboration Agreement in the U.S.

and to share all operating profits and losses for activities under the Biogen Collaboration Agreement solely for the U.S.

The Biogen Collaboration Agreement provides that Biogen has sole responsibility and decision-making authority with respect to such activities in the Biogen Territory.

Biogen is solely responsible for all costs for activities under the Biogen Collaboration Agreement in the Biogen Territory.

We have an Opt-Out Right (as defined below) in the U.S.

with respect to the Licensed Zuranolone Products.

We have granted to Biogen a non-transferable, sublicensable, except for certain specified exceptions, license to certain of our intellectual property as needed to perform the activities under the Biogen Collaboration Agreement.

Such license is co-exclusive with us in the U.S.

and exclusive, even as to us, in the Biogen Territory, subject to certain retained rights to allow us to exercise our rights and perform our obligations under the Agreement and with respect to the Shionogi Territory.

Our activities for the Licensed Zuranolone Products in the U.S.

are conducted pursuant to joint plans agreed to by us and Biogen, and overseen by a joint steering committee, or the JSC.

The JSC is composed of an equal number of representatives from each of us and Biogen.

For so long as a Licensed Zuranolone Product is being sold in the U.S., we and Biogen will share equally in all operating profits and losses arising from such Licensed Zuranolone Product in the U.S.

The Biogen Collaboration Agreement provides that Biogen will record sales of Licensed Zuranolone Products globally.

Consistent with this provision, Biogen records sales of ZURZUVAE in the U.S.

We have the right to opt out (Opt-Out right) of such profit- and loss-sharing with respect to the Licensed Zuranolone Products in the U.S.

If we elect to exercise our Opt-Out Right with respect to the Licensed Zuranolone Products, we have agreed to transition to Biogen applicable development and commercialization activities for such Licensed Zuranolone Products for the U.S., and Biogen has agreed to assume sole operational and financial responsibility for such activities.

The Biogen Collaboration Agreement provides for aggregate regulatory/commercial milestone payments from Biogen to us for Licensed Zuranolone Products.

Biogen has also agreed to pay us tiered royalties based on net sales of the Licensed Zuranolone Products in the Biogen Territory of high-teens to low-twenties percentages.

If we have exercised our Opt-Out Right in the U.S.

with respect to Licensed Zuranolone Products, Biogen has agreed to pay us specified royalties based on net sales of Licensed Zuranolone Products.

Royalty payments may be reduced in certain specified customary circumstances.

Due to the uncertainty of pharmaceutical development and the high historical failure rates generally associated with drug development, we may never receive additional milestone payments or any royalty payments from Biogen.

During the term of the Biogen Collaboration Agreement, neither us nor Biogen nor any of our respective affiliates is permitted outside of the Biogen Collaboration Agreement to directly or indirectly develop, manufacture, conduct medical affairs activities or commercialize certain products in specified indications, or enter into agreements or arrangements with third parties to perform any of the above activities.

Unless earlier terminated, the Biogen Collaboration Agreement expires on a Licensed Product-by-Licensed Product and country-by-country basis on the later of (i) in the Biogen Territory, the expiration of the royalty term for such Licensed Product in such country or (ii) in the U.S., until the parties agree to permanently stop commercializing such Licensed Product.

terminate the Biogen Collaboration Agreement for convenience in its entirety or on a Product Class-by-Product Class basis, or as to a region by providing advance written notice.

Either us or Biogen may terminate the Biogen Collaboration Agreement (i) in the event of a material breach in whole or in part, by the other party subject to a cure period and (ii) in the event of the insolvency of the other party, in each case subject to specified conditions.

For additional information related to the Biogen Collaboration Agreement, see the Risk Factor captioned The commercial results of ZURZUVAE® (zuranolone) depend, in part, on our ability, with our collaboration partner, Biogen MA Inc., and Biogen International GmbH, or together, Biogen, to successfully continue the commercialization of the product for the treatment of women with postpartum depression, or PPD, in the U.S.

There is no assurance that our commercialization efforts in the U.S.

with respect to ZURZUVAE for the treatment of women with PPD will be successful or that we will be able to generate revenues at the levels or on the timing we expect or at levels or on the timing necessary to support our goals under Part I, Item 1A, Risk Factors of this Annual Report.

Through the Sage Acquisition, we also obtained a collaboration agreement with Shionogi & Co.

Pursuant to this agreement, Shionogi is responsible for all clinical development, regulatory filings and commercialization of products containing zuranolone for the treatment of MDD and potentially other indications in the Shionogi Territory.

Shionogi made an upfront payment of $90.0 million in 2018 (prior to our acquisition of Sage), and we will be eligible to receive additional payments of up to $470.0 million if certain regulatory and commercial milestones are achieved by Shionogi.

Under the terms of the agreement, the potential future milestone payments include up to $40.0 million for the achievement of specified regulatory milestones, up to $30.0 million for the achievement of specified commercialization milestones, and up to $385.0 million for the achievement of specified net sales milestones.

We will receive tiered royalties on sales of zuranolone in the Shionogi Territory, if development efforts are successful, with tiers averaging in the low to mid-twenty percent range, subject to other terms of the agreement.

Due to the uncertainty of pharmaceutical development and the high historical failure rates generally associated with drug development, we may not receive any additional milestone payments or any royalty payments from Shionogi.

Shionogi's exclusive rights to develop and commercialize products containing zuranolone are limited to the Shionogi Territory.

The upfront cash payment and any payments for milestones and royalties are non-refundable and non-creditable.

The agreement with Shionogi will terminate on a licensed product-by-licensed product basis on the date on which the royalty term has expired in each country in the Shionogi Territory for such licensed product and will ultimately expire upon the expiration of the last-to-expire royalty term.

Shionogi may remove South Korea or Taiwan from the covered territories, for any reason or no reason upon 180 days’ prior written notice.

Shionogi may terminate the agreement in its entirety for any reason or no reason upon 180 days’ prior written notice.

Shionogi may also terminate the agreement in the event of a serious adverse event or a clinical failure upon 60 days’ written notice to us.

Either party may terminate this agreement early in the event of an uncured material breach within 180 days’ after notice is delivered to the other party.

APOKYN and ONAPGO (apomorphine hydrochloride)

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and we are prohibited from selling or distributing in the U.S.

certain product that compete with XADAGO.

certain products that compete with XADAGO.

Also, Zambon is eligible to receive up to $30.0 million in future payments upon the achievement of sales-based milestones, which are based upon specified annual net product sales of XADAGO in the U.S.

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

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.

This minimum purchase requirement represents the in-substance fixed contract consideration associated with the dedicated manufacturing facility.

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

The Merz Agreement may not be terminated for convenience.

An amendment to the contract manufacturing agreement with Merz was executed in July 2025.

Amendments to the contract manufacturing agreement included among other things, the removal of an annual minimum purchase requirement of MYOBLOC, and the Company's agreement to pay a nonrefundable annual fee of €3.0 million to cover general maintenance and reservation costs for the manufacturing facilities.

SPN-817 (huperzine A)

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In addition, we will be obligated to pay a low single digit royalty on net sales to the prior Biscayne security holders and any applicable royalties to third parties for the use of in-licensed IP.

The maximum combined royalty we will pay to all parties on net product sales is approximately 12%, depending on the IP covering the commercial product and the applicable tiered sales levels.

On January 22, 2026, the Company entered into an agreement with former Biscayne security holders in which the Company will pay $10.0 million by June 30, 2026, for settlement of certain developmental milestones under the merger agreement entered into in 2018.

SPN-820 (NV-5138)

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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.

On May 5, 2025, the Company entered into a binding memorandum of understanding (MOU) with Navitor Inc.

Under the MOU, the Company agreed to conduct further development activities at its own cost and Navitor Inc.

agreed to waive its right to receive the $100 million Initial Acquisition Fee under the Development Agreement.

In addition, pursuant to the MOU the Company exercised the Purchase Option to purchase all assets of Navitor and its affiliates pursuant to the Development Agreement, subject to, among other things, completion of satisfactory due diligence by the Company, and negotiation and execution of a definitive Purchase Agreement.

On June 24, 2025, October 31, 2025 and December 22, 2025, the Company amended the MOU with Navitor to extend the negotiation period.

See Part II, Item 8, Financial Statements and Supplementary Data , Note 18, Commitments and Contingencies , in the Notes to the Consolidated Financial Statements.

Namzaric (memantine hydrochloride extended release and donepezil hydrochloride) capsules for the treatment of moderate to severe dementia of an Alzheimer's type is currently marketed by Allergan plc under an exclusive license agreement between Adamas Pharmaceuticals and Forest Laboratories Holdings Limited (Forest), an indirect, wholly-owned subsidiary of Allergan plc (collectively, Allergan) in the United States.

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

The royalty term for Orenitram is expected to cease in 2026.

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.

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The False Claims Act provides that any Person who knowingly submits false claims to the government is liable for treble damages as well as additional penalties.

As a consequence of the USWM Acquisition, and under the terms of the CIA, the Company has assumed the extensive obligations of the MDD Subsidiaries concerning the ongoing maintenance of an effective compliance and disclosure program to promote compliance with the statutes, regulations and written directives of Medicare, Medicaid and all other Federal health care programs and with the statutes, regulations and written directives of the FDA.

The CIA has a term of five years, with the final Reporting Period ending in April 2024, and imposes material burdens on the Company, its officers and directors to take actions designed to ensure compliance with applicable healthcare laws, including requirements to maintain specific compliance positions within the Company, to report any non-compliance with the terms of the agreement, to submit annual reports to the Office of Inspector General of the U.S.

As a consequence of the USWM Acquisition, and under the terms of the CIA, the Company assumed the extensive obligations of the MDD Subsidiaries concerning the ongoing maintenance of an effective compliance and disclosure program to promote compliance with the statutes, regulations and written directives of Medicare, Medicaid and all other Federal health care programs and with the statutes, regulations and written directives of the FDA.

The CIA has a term of five years, with the final Reporting Period ending in April 2024, and imposed material burdens on the Company, its officers and directors to take actions designed to ensure compliance with applicable healthcare laws, including requirements to maintain specific compliance positions within the Company, to report any non-compliance with the terms of the agreement, to submit annual reports to the Office of Inspector General of the U.S.

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.

In addition, the Company may be excluded from participation in federally funded healthcare programs for a material breach of the CIA, which would result in substantial losses to the Company.

The Company submitted its final report during the second quarter of 2024 and received an official notification of release from the Office of the Inspector General in April 2025 and thus no longer remains subject to its obligations under the CIA.

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.

Additional changes to the HealthCare Reform Law include The American Taxpayer Relief Act of 2012, which reduced Medicare payments to several types of providers and increased the statute of limitations period for the government to recover overpayments to providers from three years to five years.

has enacted a number of legislative and regulatory proposals to change the healthcare system in ways that could affect our ability to sell our products profitably.

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This is accomplished primarily through the imposition of health insurance mandates on employers and individuals and the expansion of the Medicaid program.

In March 2010, a comprehensive change to the U.S.

healthcare system, known as the Patient Protection and Affordable Care Act of 2010 (ACA) was enacted, as amended by the Health Care and Education Reconciliation Act of 2010.

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

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

Changes in the 2025 CMS marketplace rules include, among other things, the expiration of enhanced premium tax credits, eligibility changes for Deferred Action for Childhood Arrival recipients, the elimination of the Special Enrollment Period for individuals with incomes at or below 150% of the Federal Poverty Level except with a Qualifying Life Event, stricter income verification, and the elimination of the automatic 60-day extension to resolve income inconsistencies (reverting to the standard 90 days).

Reductions in subsidies, such as the expiration of the enhanced premium tax credits, may reduce the number of patients with health insurance, which in turn could reduce patients’ ability to purchase our products.

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.

Among the provisions of the HealthCare Reform Law of importance to the Company's products and product candidates are the following:

• An annual, nondeductible fee payable to the U.S.

federal government by any entity that manufactures or imports specified branded prescription drugs or biologic agents.

This fee is based on each company's market share of prior year total sales of branded products to certain federal healthcare programs;

• 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 (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;

• Extension of manufacturers' Medicaid rebate liability to individuals enrolled in Medicaid managed care organizations;

• Expansion of the eligibility criteria for Medicaid programs in certain states;

• Expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;

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

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

In addition to FDA restrictions on the marketing of pharmaceutical products, several other types of state and federal laws have been applied to restrict certain business and marketing practices in the pharmaceutical industry in recent years.

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and security and transparency statutes and regulations.

Regulations include, but are not limited to:

• The federal healthcare program Anti-Kickback Statute (AKS), which prohibits, among other things, persons from knowingly and willfully soliciting, receiving or providing remuneration, directly or indirectly, to induce either the referral of an individual for an item or service or the purchasing or ordering of a good or service, for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs.

A person or entity does not need to have actual knowledge or specific intent to violate the federal AKS to have committed a violation.

Further, the government may assert that a claim, including items and services resulting from a violation of the federal AKS, constitutes a false or fraudulent claim for purposes of the federal False Claims Act, as discussed below.

On December 2, 2020, additional AKS regulations were finalized and took effect in January 2021, which modified existing AKS safe harbors, created new AKS safe harbors, and created a new CMP law exception.

Safe harbors protect certain arrangements from prosecution if each of the elements of the safe harbor is satisfied;

• The HHS OIG Special Fraud Alert published on November 16, 2020, which addresses the manufacturer Speaker Programs, and signals both a narrower government view of AKS compliance with respect to such programs as well as the potential for increased enforcement in the space by government oversight agencies such as OIG and the Department of Justice;

• Federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things:

individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent;

knowingly making a false statement material to an obligation to pay or transmit money to the federal government;

or knowingly concealing or improperly avoiding or decreasing an obligation to pay money to the federal government;

• Federal physician payment transparency requirements under the ACA, commonly referred to as the Physician Payments Sunshine Act, which requires manufacturers of drugs, devices, biologics, and medical supplies to report to HHS information related to physician payments, and to report other transfers of value, physician ownership, and investment interests;

• Federal price reporting laws, which require the Company to calculate and report complex pricing metrics to government programs, where such reported prices may be used in the calculation of reimbursement and/or discounts on the Company's commercial products;

• The FDCA, which among other things, strictly regulates drug product marketing, prohibits manufacturers from marketing drug products for off-label use, and regulates the distribution of drug samples;

• State law equivalents of each of the above federal laws, such as state anti-kickback laws, physician payment, and drug pricing transparency laws, and false claims laws, which may apply to the Company's business practices, including, but not limited to:

(i) research, distribution, sales and marketing arrangements;

(ii) claims for items or services reimbursed by any third-party payor, including commercial insurers;

(iii) state laws that require pharmaceutical companies to comply with the pharmaceutical industry's voluntary compliance guidelines, and the applicable compliance guidance promulgated by the federal government;

and (iv) state laws that otherwise restrict payments that may be made to healthcare providers.

Many of these state laws differ from one another in significant ways and often are not preempted by federal laws, thus complicating compliance efforts;

• Certain state laws require pharmaceutical companies to comply with voluntary compliance guidelines promulgated by a pharmaceutical industry association and relevant compliance guidance issued by HHS OIG, bar drug manufacturers from offering or providing certain types of payments or gifts to physicians and other healthcare providers, and/or require disclosure of gifts or payments to physicians and other healthcare providers;

• Pricing and rebate programs must comply with the Medicaid rebate requirements of the Omnibus Budget Reconciliation Act of 1990, as amended, and the Veterans Health Care Act of 1992, as amended (VHCA).

If the Company's products are made available to authorized users of the Federal Supply Schedule of the General Services Administration, then additional laws and requirements apply.

Under the VHCA, drug companies are required to offer certain pharmaceutical products at a reduced price to several federal agencies, including the United States Department of Veterans Affairs and United States Department of Defense, the Public Health Service, and certain private Public Health Service—designated entities, in order to participate in other federal funding programs including Medicare and Medicaid.

Recent legislative

changes purport to require that discounted prices be offered for certain United States Department of Defense purchases for its TRICARE program via a rebate system.

Participation under the VHCA requires submission of pricing data and calculation of discounts and rebates pursuant to complex statutory formulas, as well as the entry into government procurement contracts governed by the Federal Acquisition Regulations;

• Similar healthcare laws in the European Union and other jurisdictions, including reporting requirements detailing interactions with and payments to healthcare providers.

• The Federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), which prohibits a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters.

Similar to the federal AKS, a person or entity does not need to have actual knowledge or specific intent to violate HIPAA in order to have committed a violation.

On December 10, 2020, HHS released proposed modifications to the HIPAA Privacy Rule, which, if adopted, would change rules related to patient access to HIPAA protected records, among others.

In 2021 OCR sought feedback on the proposed HIPAA changes.

Publication of the Final Rule has not yet occurred;

• HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (commonly referred to as the HITECH Act), which imposes certain requirements relating to the privacy, security, and transmission of individually identifiable health information;

• Various state and foreign laws also govern the privacy and security of health information in some circumstances, and many of these laws differ from each other in significant ways and often are not preempted by HIPAA.

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.

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HITECH also created four new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys' fees and costs associated with pursuing federal civil actions.

In addition, state laws govern the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

In addition, state

laws govern the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

In order to be eligible to have our products paid for with federal funds under the Medicaid and Medicare Part B programs and purchased by certain federal agencies and grantees, we must comply with the Veterans Health Care Act of 1992 (VHCA).

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

In February 2026, pharmacy benefit manager reform provisions were enacted as part of the Consolidated Appropriations Act of 2026.

These reforms, which are scheduled to be implemented in 2028, require that certain compensation to pharmacy benefit managers under Medicare Part D be structured as bona fide service fees that are fixed dollar amounts, satisfy regulatory requirements for bona fide service fees, and are not determined based on a drug’s price or volume.

The legislation also restricts the use of spread pricing and certain rebate-based renumeration, and imposes additional transparency and reporting obligations.

Although these provisions primarily regulate intermediaries, they may affect coverage of our products and could adversely affect revenues.

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 November 17, 2023, CMS released final program guidance to pharmaceutical manufacturers and Part D plan sponsors for implementing the Medicare Part D Manufacturer Discount Program.

HHS and CMS are continuing to announce drugs for price negotiation, produce draft guidance, and finalize regulations in an effort to implement to IRA.

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.

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

Beginning in 2025, all Medicare prescription drug plans (Medicare Part D plans) — including both standalone Medicare prescription drug plans and Medicare Advantage plans with prescription drug coverage — were required to offer enrollees the option to pay out-of-pocket prescription drug costs in the form of capped monthly installment payments instead of all at once at the pharmacy.

In January 2026, CMS announced the election of 15 additional prescription drugs for negotiation, representing the third round of drugs selected under the program.

Negotiated prices for these drugs, once agreed, will become effective January 1, 2028.

None of the selected drugs were Supernus products.

The Company cannot predict whether additional legislation or rulemaking related to the IRA will be issued or enacted, or what impact, if any, such changes will have on the profitability of any of the Company's products.

There also may be future changes unrelated to the IRA that result in reductions in potential coverage and reimbursement levels for the Company's products, and we cannot predict the scope of any future changes or the impact that those changes may have on its business.

In addition, a Medicare Part D prescription drug $2,000 out-of-pocket limit was implemented.

healthcare cost containment statutes and policy measures include:

• The 2013 Drug Quality and Security Act (DQSA) creates the requirement for companies to trace, verify and identify all products through the entire supply chain, from manufacturer to dispenser.

Title I of the DQSA, the Compounding Quality Act, increased regulation of compounding drugs.

Title II of DQSA, the Drug Supply Chain Security Act (DSCSA) established requirements to facilitate improved tracking of prescription drug products through the supply chain with increased product identification requirements.

DSCSA requires such tracking to be done farther down the distribution chain, including (i) wholesalers' verification and tracking, (ii) pharmacy verification and tracking, and (iii) at the unit level throughout the entire supply chain.

In August 2023, FDA announced final guidance pertaining to Title II, entitled “Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies.” This guidance describes FDA’s compliance policies for enforcement of requirements for the interoperable, electronic, package level product tracing (enhanced drug distribution security requirements) under the Federal Food, Drug, and Cosmetic Act (FDCA), effective November 27, 2023.

Specifically, the guidance described that, until November 27, 2024, the FDA did not intend to take action to enforce requirements for the interoperable, electronic, package level product tracing under section 582(g)(1) of the FDCA Act that went into effect on November 27, 2023.

The FDA issued an additional guidance document in October 2024 noting that companies in the pharmaceutical distribution supply chain who have initiated their systems and processes and established electronic DSCSA data connections with their trading partners may need additional time beyond November 27, 2024 to strengthen capabilities to mitigate data issues associated with electronic DSCSA transaction information and transaction statements to ensure uninterrupted product distribution.

The October 2024 guidance specifies that the FDA is responding to such need by issuing exemptions to accommodate the additional time needed by such trading partners beyond November 27, 2024, but such exemptions apply only to trading partners who have initiated their systems and processes and established electronic DSCSA data connections with their trading partners prior to November 27, 2024.

The guidance also provides that such exemptions will extend beyond November 27, 2024, for different lengths of time depending on the category of the trading partner (i.e., manufacturers and repackagers, wholesale distributors, dispensers with 26 or more full time employees).

The Trump Administration has not made any updates to, or rescinded, the October 2024 guidance document.

• In 2016, the 21st Century Cures Act (Cures Act) was enacted and authorized increased funding for the FDA to spend on innovation projects, amended the Public Health Service Act (PHSA) to reauthorize and expand funding for the National Institutes of Health (NIH), established the NIH Innovation Fund to pay for the cost of development and implementation of a strategic plan, early stage investigations, and research;

and charged the NIH with leading and coordinating expanded pediatric research.

The Cures Act also directed the Centers for Disease Control and Prevention to expand surveillance of neurological diseases.

There often are delays between the enactment of laws and the effective date of regulations for the enforcement of laws, and this was the case for the Cures Act.

Although enacted in 2016, the Department of Health and

Human Services (HHS), Office of Inspector General (OIG) did not publish a final rule amending the civil money penalty (CMP) regulations of HHS OIG until July 3, 2023.

This final rule implements three statutory provisions:

(1) the amendment of the PHSA by the Cures Act authorizing OIG to investigate claims of information blocking;

(2) the amendment of the Civil Monetary Penalties Law (CMPL), authorizing HHS to impose CMPs, assessments, and exclusions upon individual and entities that engage in fraud and other misconduct related to HHS grants, contracts, and other agreements;

and (3) the increase in penalty amounts in the CMPL effected by the Bipartisan Budget Act of 2018.

• The One Big Beautiful Bill Act (OBBBA) was enacted on July 4, 2025.

OBBBA includes provisions that will, among other things, expand the orphan drug exception by allowing products with one or more orphan drug designations and one or more approved indications to remain exempt from price negotiation if each indication is for a rare disease or condition and extend the price negotiation program to be effective on the date of non-orphan indication instead of on the date of first approval or licensing.

These provisions may impact development processes and price analyses.

OBBBA also enacted approximately $1 trillion in Medicaid cuts and imposed additional eligibility requirements.

These measures may eliminate Medicaid coverage for up to 10.5 million people, and reduce so-called “dual eligible” enrollment (i.e., enrollment in both Medicare and Medicaid) by 1.3 million people, with less coverage likely to correlate to fewer prescriptions covered by the program and a greater need for manufacturer discounts and expanded patient assistance programs.

Although OBBBA established a $50 billion Rural Health Transformation Program (RHTP), known as the “Rural Hospital Fund,” to lessen the impact of Medicaid cuts on rural hospitals, there are concerns that the RHTP may be insufficient to cover the gap, and many hospitals may still close or shift resources to the already troubled 340B Drug Pricing Program, which requires drug manufacturers to sell outpatient drugs at discounted prices to eligible healthcare providers that serve many uninsured and low-income patients.

In addition, OBBBA implements a state cost-sharing provision that could place up to 15% of Medicaid costs onto individual states, potentially straining state and local health care budgets and impacting purchasing capabilities.

The full impact of OBBBA’s changes to Medicaid on the Company’s business is not yet known.

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.

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

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 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.

Other Information

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The summary below is not exhaustive and is qualified by reference to the full set of risk factors set forth in this "Risk Factors” section.

RISK FACTORS.

Risks Related to Our Industry and Business

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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.

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Security breaches and other disruptions could compromise our information and expose us to liability which would cause our business and reputation to suffer.

• Compliance with the terms and conditions of our Corporate Integrity Agreement requires significant resources and management time and, if we fail to comply, we could be subject to penalties or, under certain circumstances, excluded from government healthcare programs, which would materially adversely affect our business.

• Ongoing legal actions and proceedings could distract management and could result in substantial costs or large judgments against Supernus or one or more of its subsidiaries.

• Our future business prospects for ZURZUVAE® (zuranolone) depend on our ability, with our collaboration partner, Biogen MA Inc., and Biogen International GmbH, or together, Biogen, to successfully commercialize ZURZUVAE® (zuranolone) for the treatment of women with postpartum depression, or PPD, in the U.S.

There is no assurance that our commercialization efforts in the U.S.

RISK FACTORS.

Risks Related to Our Finances and Capital Requirements

• Tariffs may increase our costs.

• Our operating results may fluctuate significantly.

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A substantial amount of our resources is focused on generating, maintaining and/or expanding the revenue generated by our approved products in the U.S.

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.

Our major products Qelbree ® , GOCOVRI ® , Oxtellar XR ® , APOKYN ® , and ZURZUVAE ® represented approximately 49%, 23%, 6%, and 8% of our total net revenues for the year ended December 31, 2025, respectively.

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.

For example, in November 2025 we announced that supplier constraints were impacting our ability to fully meet demand for ONAPGO and that this required pausing delivery of the product to patients who had not yet started ONAPGO, resulting in an adverse impact on our revenue and profit during the fourth quarter of 2025.

In February 2026, we announced that we have made progress securing additional product supply of ONAPGO from the current supplier and as a result has resumed new patient initiation.

In addition, we are working with a second supplier that is expected to begin supplying ONAPGO in 2027.

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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• Produce, through a validated process, sufficiently large quantities of our products to meet demand;

RISK FACTORS.

• Continue to maintain a wide variety of internal sales, distribution, and marketing capabilities, sufficient to sustain and grow revenue;

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• Obtain approval from the FDA to expand the labeling of our approved products for additional indications;

• Maintain compliance with the Drug Enforcement Administration’s regulation of certain controlled substances, such as ZURZUVAE;

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

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cause us to modify how we market our approved products;

subject us to

RISK FACTORS.

substantial liabilities;

subject us to 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 one or more of the active pharmaceutical ingredients present in our products are approved and successfully commercialized, our business could be materially harmed.

RISK FACTORS.

If other versions of our products, including but not limited to generics containing one or more of the active pharmaceutical ingredients present in our products are approved and successfully commercialized, or if products are developed, approved and successfully commercialized which provide similar benefits of treatment for patients, 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.

Upsher-Smith also entered into a settlement with two generic companies to launch a generic to Qudexy XR in 2020.

In February 2021, one of the generic companies, Glenmark, entered the U.S.

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

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.

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 beginning on January 2023 and September 2024, respectively.

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

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

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.

Third parties have, and in the future may, receive approval to manufacture and market their own products, including but not limited to generics containing apomorphine hydrochloride, for the treatment of Parkinson’s Disease in the U.S.

For example, in 2019, Acorda Therapeutics, Inc.

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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.

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.

Third parties have developed, received FDA approval and successfully commercialized longer-lasting extended relief levodopa/carbidopa products, which are impacting sales of APOKYN because they reduce the number of times per day a given patient may need to use an off-episode product like APOKYN.

Third parties have also developed, received FDA approval and successfully commercialized products that compete with ONAPGO.

For example, in 2024, AbbVie launched Vyalev, a treatment for advanced PD that utilizes a wearable pump to provide a continuous infusion of foscarbidopa and foslevodopa.

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

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

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In addition, these pressures are intensified by increased, adverse publicity about pricing for pharmaceuticals.

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

These prices are sometimes characterized as excessive, leading to government actions, including 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 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.

Third-party payors are increasingly challenging the effectiveness of and prices charged for medical products and services.

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.

Third-party payors are increasingly challenging the effectiveness of and prices charged for medical products and

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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This would have a material adverse effect on our overall business and financial condition.

There has been increasing legislative and enforcement interest in the U.S.

with respect to specialty drug pricing practices.

There has been increasing interest in the U.S.

from both the executive and legislative branches with respect to specialty drug pricing practices.

Specifically, there have been several recent U.S.

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.

Additionally, several Executive Orders have been issued generally aimed at lowering the price of certain pharmaceutical products in the United States.

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.

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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.

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

To obtain favorable reimbursement for the indications sought, or to obtain pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our products or product candidates, if approved, to other available therapies.

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 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.

As evidenced by the passage of the American Rescue Plan Act of 2021 and Inflation Reduction Act of 2022, discussed in greater detail below, and the President's Executive Orders in 2025, we expect these challenges to continue and to potentially intensify during 2026, as political pressures mount, and healthcare payors, including government-controlled health authorities,

RISK FACTORS.

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.

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 GOCOVRI and APOKYN are made to specialty pharmacies.

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

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We may not be able to effectively market and sell our product candidates, if approved, in the U.S.

We plan on expanding our sales and marketing capabilities in the U.S.

to commercialize new product candidates if approved.

This will require investing significant amounts of financial and management resources.

If we are unable to establish and maintain adequate sales and marketing capabilities for new product candidates or do so in a timely manner, we may not be able to generate sufficient product revenues from our product candidates to be profitable.

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Our business depends on successful clinical development i.e., successful completion of clinical trials and completion of requisite manufacturing information.

We are not permitted to market any of our product candidates in the U.S.

until we receive approval of an NDA from the FDA or market in any foreign jurisdiction until we receive approval from the requisite authority.

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

We are not permitted to market a product candidate in the U.S.

RISK FACTORS.

approval to commercialize our product candidates.

receive approval of an NDA from the FDA or market in any foreign jurisdiction until we receive approval from the requisite authority.

Satisfaction of regulatory requirements typically takes many years, is dependent upon the type, complexity, and novelty of the product candidate, 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, therefore, predict the timing of any future revenues from these product candidates.

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Notwithstanding the approval of many products by the FDA pursuant to Sections 505(b)(1) and 505(b)(2), over the last few years, some pharmaceutical 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) application 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, then this could delay or even prevent the FDA from approving any Section 505(b)(2) application that we submit.

Any failure to obtain regulatory approval of our product candidates would eliminate our ability to generate revenues for that candidate.

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The FDA could in the future require additional regulation under the medical device provisions of the FDCA.

We must comply with the QSR, which sets forth the FDA's cGMP, requirements for medical devices, and other applicable government regulations and corresponding foreign standards for drug cGMPs.

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

We must comply with the QSR, which sets forth the FDA's cGMP, requirements for medical devices, and other applicable government

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.

regulations and corresponding foreign standards for drug cGMPs.

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

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.

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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.

We may have limited control over third parties, and we cannot guarantee that they will perform their obligations in an effective, competent, and timely manner.

We have limited control over third parties, and we cannot guarantee that they will perform their obligations in an effective, competent, and timely manner.

For example, in November 2025, we announced that due to stronger than expected demand for ONAPGO, supplier constraints are impacting the Company's ability to fully meet demand.

In February 2026, we announced that we have made progress securing additional product supply of ONAPGO from the current supplier and as a result has resumed new patient initiation.

In addition, we are working with a second supplier that is expected to begin supplying ONAPGO in 2027.

Our reliance on third parties, including third-party Clinical Research Organizations (CROs) and CMOs, entails risks including, but not limited to:

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We do not currently own or operate manufacturing facilities for the commercial production of any of our products or for production of clinical supplies of our product candidates, nor do we have plans to do so in the future.

We currently depend on third-party clinical manufacturing organizations (CMOs), who offer a comprehensive range of contract manufacturing and packaging services, in various countries for the supply of API for our products and product candidates, including raw materials and drug substances for our preclinical research and clinical trials.

We currently depend on third-party CMOs, who offer a comprehensive range of contract manufacturing and packaging services, in various countries for the supply of API for our products and product candidates, including raw materials and drug substances for our preclinical research and clinical trials.

For most of our products and product candidates, we rely on single source suppliers to produce and package final dosage forms for our products and raw materials, including API.

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.

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, product demand, and necessary quality standards for the development or commercialization of products would be adversely affected.

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.

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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 ONAPGO (formerly known as SPN-830), Qelbree, APOKYN, XADAGO, and MYOBLOC where various suppliers are based in Europe.

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

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

Pharmaceutical companies and their suppliers often encounter difficulties in manufacturing, particularly in scaling up the production of their products.

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.

These problems can adversely affect production costs and yields, quality control, the stability of the product and quality assurance testing, as well as compliance

RISK FACTORS.

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

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.

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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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.

In such an event, our future revenues could be reduced materially.

In such an event, our future revenues from such product candidates could be reduced materially.

If the FDA or other applicable regulatory authorities approve generic products that compete with any of our products or product candidates, the sales of our products or the commercial success of our product candidates would be adversely affected.

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These generic equivalents, which must meet the same quality standards as branded pharmaceuticals, would be significantly less costly than ours to bring to market.

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

Companies that produce generic equivalents are generally able to

RISK FACTORS.

both price and volume erosion.

offer their products at significantly lower prices.

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.

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We may be unable to differentiate our products from competitive offerings.

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 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).

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

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

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As a result of these factors, our competitors may obtain regulatory approval of their products more rapidly than we are able to or may obtain patent protection or other intellectual property rights that limit or block us from developing or commercializing our product candidates.

Our competitors may also develop drugs that are more effective, have faster onset to action, better tolerated, subject to fewer or less severe side effects, more widely prescribed or accepted, or less costly than ours.

Our competitors may also develop drugs that are more effective, have faster onset to action, are better tolerated, subject to fewer or less severe side effects, are more widely prescribed or accepted, or are less costly than ours.

They may also be more successful than us in manufacturing and marketing their products.

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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, 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.

For example, certain of our products, including Qelbree, ONAPGO, ZURZUVAE, 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 (i) 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 (ii) 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 also have a post-marketing

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.

commitment to conduct a new leachable study for ONAPGO.

The final protocol was submitted in September 2025.

The final report is expected to be submitted in 2028.

We have post-marketing commitments for ZURZUVAE including the requirement to (i) conduct an embryofetal development study in a second species and (ii) Pediatric Research Equity Act sNDA as an efficacy supplement, including proposed labeling updates, and also plans to include nonclinical labeling and carton/container artwork updates.

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

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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.

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, then the FDA could take enforcement action against us, including withdrawal of approval.

Our products, product candidates, and our collaborators' approved products are subject to ongoing FDA requirements governing the labeling, packaging, storage, advertising, promotion, recordkeeping, and submission of safety and other information.

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 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:

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, then 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.

• Issue warning letters or untitled letters;

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In particular, a product may not be promoted for uses that are not approved by the FDA, as reflected in the product's approved labeling.

Notwithstanding, physicians may nevertheless prescribe products to their patients in a manner that is inconsistent with the approved label, which is known as "off label use".

However, physicians may prescribe products to their patients in a manner that is inconsistent with the approved label, which is known as "off label use".

The FDA and other authorities actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have promoted off-label use may be subject to significant sanctions.

The federal government has levied large civil and criminal fines against companies for alleged improper promotion and has enjoined companies from engaging in off-label promotion.

If we are found to have promoted off-label use, we may be enjoined from such off-label promotion and become subject to significant liability.

If we are found to have promoted off-label use, then we may be enjoined from such off-label promotion and become subject to significant liability.

This could have an adverse effect on our reputation, business, revenues, and profits.

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Additional government regulations may be enacted that could affect our products, or prevent, limit, or delay regulatory approval of our product candidates.

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.

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, then we may lose any marketing approval that we have obtained, adversely affecting our business and prospects, as well as our ability to achieve or sustain profitability.

RISK FACTORS.

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If we fail to comply with our obligations under any of these arrangements, we could lose the benefit of such collaborative relationships, including licenses or intellectual property rights.

Under the Britannia Supply Agreement, we have been granted certain intellectual property and product rights in relation to APOKYN, including the right to use and market APOKYN in the United States.

We rely on third-party collaborators and strategic partners to market and commercialize our products and product candidates outside the U.S.

We are party to and rely on several arrangements with third parties which provide us with rights to intellectual property that are necessary for the development of certain of our product candidates.

We also have agreements with leading CMOs to manufacture other commercial products and the API for such products

Under the Britannia Supply Agreement, we have been granted certain intellectual property and product rights in relation to APOKYN and ONAPGO, including the right to use and market those products in the United States.

Additionally, the Britannia Supply Agreement grants Britannia certain intellectual property and product rights in relation to APOKYN, including the right to use and market APOKYN in the rest of the world, excluding the United States.

Per the Agreement, Britannia has an obligation to supply us with APOKYN for our marketing and sale of the product.

Per the Agreement, Britannia has an obligation to supply us with APOKYN for our marketing and sale of the product, and supplies us with ONAPGO.

Britannia may terminate its obligation to supply APOKYN for cause, or at any time, by giving at least twenty-four months' written notice.

The Britannia Supply Agreement does not provide technology transfer assistance from Britannia to any new suppliers we might engage following termination.

In addition, the Britannia Supply Agreement is silent in providing us with an explicit license grant to any intellectual property, or to access know-how necessary or useful for manufacturing APOKYN.

If we materially breach the Britannia Supply Agreement, or Britannia chooses to terminate the Britannia Supply Agreement for convenience, we could lose the right and resources necessary for the manufacture of APOKYN or could incur significant costs implementing technology transfer assistance.

We also have agreements with leading CMOs to manufacture other commercial products and the API for such products.

These CMOs offer a comprehensive range of contract manufacturing services.

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.

The Company is eligible to receive, and has received royalties under this agreement based on net product sales of United Therapeutics Corporation's product, Orenitram (treprostinil).

We are entitled to receive milestones and royalties for the use of this formulation in indications other than arterial hypertension.

Namzaric (memantine hydrochloride extended release and donepezil hydrochloride) capsules for the treatment of moderate to severe dementia of an Alzheimer's type is currently marketed by Allergan plc under an exclusive license agreement between Adamas Pharmaceuticals, LLC and Forest Laboratories Holdings Limited ("Forest"), an indirect, wholly-owned subsidiary of Allergan plc (collectively, "Allergan") in the United States.

Adamas Pharmaceuticals LLC receives royalties on net sales of Namzaric.

We rely on third-party collaborators and strategic partners to market and commercialize our products and product candidates outside the U.S.

We are party to and rely on several arrangements with third parties which provide us with rights to intellectual property that are necessary for the development of certain of our product candidates.

In addition, the Britannia Supply Agreement is silent in providing us with an explicit license grant to any intellectual property, or to access know-how necessary or useful for manufacturing APOKYN or ONAPGO.

If we materially breach the Britannia Supply Agreement, or Britannia chooses to terminate the Britannia Supply Agreement for convenience, we could lose the right and resources necessary for the manufacture of APOKYN and ONAPGO or could incur significant costs implementing technology transfer assistance.

In addition, we may enter into similar arrangements in the future for other product candidates.

Our current arrangements impose various development, financial and other obligations on us.

If we materially breach these obligations, of if third parties fail to adequately perform their respective obligations, these arrangements could be terminated which could result in our inability to develop, manufacture, market and sell products that are covered by such intellectual properties.

If we materially breach these obligations, of if third parties fail to adequately perform their respective obligations, these arrangements could be terminated.

Certain agreements may be terminated by our third-party collaborators without cause.

The termination of those agreements could result in our inability to develop, manufacture, market and sell products that are covered by such intellectual properties.

We may not have sufficient resources to successfully establish future collaborations or license future arrangements on acceptable terms, if at all.

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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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• Develop and commercialize, either alone or with others, drugs that are similar to or competitive with the product candidates that are the subject of their collaboration with us;

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• Not have necessary and sufficient resources to develop the product candidate through clinical development, marketing approval, and commercialization;

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could materially diminish our revenues and harm our results of operations.

The commercial results of ZURZUVAE® (zuranolone) depend, in part, on our ability, with our collaboration partner, Biogen MA Inc., and Biogen International GmbH, or together, Biogen, to successfully continue the commercialization of the product for the treatment of women with postpartum depression, or PPD, in the U.S.

There is no assurance that our commercialization efforts in the U.S.

The commercial results of ZURZUVAE depend, in part, on our ability, along with our collaboration partner, Biogen, to successfully continue the commercialize of ZURZUVAE in the U.S.

for the treatment of women with PPD.

ZURZUVAE was approved by the United States Food and Drug Administration, or FDA, in August 2023 as a treatment for adults with PPD and became commercially available in the U.S.

in December 2023.

ZURZUVAE is the first oral treatment specifically indicated for adults with PPD.

ZURZUVAE may not achieve, or, even if achieved, maintain, broad market acceptance.

Healthcare professionals may decide not to use ZURZUVAE as a treatment option for their patients with PPD or may only consider prescribing ZURZUVAE for a subset of women with PPD in their practice who they consider to have particularly severe symptoms relative to other patients suffering from this disease.

ZURZUVAE also may not achieve or, even if achieved, maintain broad market acceptance among women with PPD who may decide that they do not want to be treated with ZURZUVAE, including due to concern about the safety and tolerability profile of ZURZUVAE or use of ZURZUVAE while breastfeeding.

The label also includes information about adverse events and other warnings and precautions that may cause a woman with PPD not to consider ZURZUVAE as a treatment option.

ZURZUVAE also may not achieve or, even if achieved, maintain broad market acceptance for the treatment of women with PPD if payors are not willing to cover and provide reimbursement for the treatment or impose significant restrictions on reimbursement.

Payors that currently have favorable coverage for ZURZUVAE for the treatment of women with PPD may decide to change their policies and limit coverage or reimbursement for ZURZUVAE, including by requiring women with PPD to try other treatments prior to ZURZUVAE, requiring a specific showing of symptom severity with the use of measurement scales, requiring prior consultation with a psychiatrist or other specialist, or imposing other onerous prior authorization requirements, or they may deny coverage or reimbursement for other reasons or in all cases.

Some payors currently require that healthcare professionals attest that the women with PPD for whom they have prescribed ZURZUVAE have severe symptoms.

In addition, even if a healthcare professional writes a prescription for ZURZUVAE for the treatment of a woman with PPD, the prescription may not result in product being shipped to the patient and/or the patient taking ZURZUVAE.

The healthcare professional or the patient may, for example, not take the steps necessary to obtain reimbursement or to have the prescription filled at the specialty pharmacy or may find the process of obtaining a prescription through the specialty pharmacy too slow or complicated.

There is no guarantee that the infrastructure, systems, processes, policies, relationships or materials we and Biogen have built for the commercialization of ZURZUVAE for the treatment of women with PPD in the U.S.

will be sufficient for us to achieve or, even if achieved, maintain success.

RISK FACTORS.

Our commercialization of ZURZUVAE in PPD may be negatively impacted by competition from other drugs currently on the market or that may be approved in the future.

The number of women with PPD, the unmet need for additional treatment options for women with PPD, and the potential market for ZURZUVAE may be significantly smaller than we expect, or we and Biogen may encounter other market-related issues in the commercialization of ZURZUVAE for the treatment of women with PPD, including as a result of the price we charge.

We and our collaboration partner, Biogen, may not be applying the optimal resources to the launch of ZURZUVAE or we or Biogen may not be able or willing to scale our resources at the right time or at an effective level.

Even if our product candidates receive regulatory approval in the U.S., we or our collaborators may not receive approval to commercialize our product candidates outside of the U.S.

To market any product outside of the U.S., we must establish and comply with numerous and varying regulatory requirements of other regulatory jurisdictions regarding safety and efficacy.

To market any product outside of the U.S., we or our collaborators must establish and comply with numerous and varying regulatory requirements of other regulatory jurisdictions regarding safety and efficacy.

For example, we are party to a collaboration and license agreement with Shionogi whereby Shionogi is responsible for, among other things, obtaining regulatory approval for zuranolone in MDD and other indications in Japan, the Republic of Korea (South Korea), and Taiwan.

In December 2025, Shionogi announced that it received regulatory approval for zuranolone in MDD in Japan.

Additionally, we are party to an agreement with Knight Therapeutics, Inc.

(Knight) granting Knight the right to commercialize Qelbree in Canada, subject to it obtaining approval by Health Canada.

In November 2025, Knight announced that it experienced regulatory setbacks for Qelbree.

Approval procedures vary among jurisdictions and can involve product testing and administrative review periods different from, and longer than, those in the U.S.

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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

RISK FACTORS.

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 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 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.

Recent Executive Orders May Impact our Financial Results.

During 2025 several Executive Orders were issued by the President of the United States, which generally aim to lower the price paid for certain pharmaceutical products in the United States.

Aspects of these orders direct the Secretary of Health and Human Services to develop implementation plans and to issue related regulations.

We are monitoring these developments and assessing the potential impact.

These Executive Orders may impact our financial results if they result in reduction in the price paid for any of our commercial products.

Certain aspects of the Executive Orders, such as those related to a “Most-Favored-Nation” (MFN) model, could have broader industry-wide effects.

For example, such policies may lead pharmaceutical companies to avoid or delay expanding sales into foreign markets to prevent triggering lower U.S.

price benchmarks, which could, in turn, reduce potential future growth opportunities.

RISK FACTORS.

We may be unable to acquire product candidates or products.

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In addition, future acquisitions may entail numerous operational and financial risks, including:

• Exposure to unknown liabilities;

• Exposure to potential and unknown liabilities;

• Disruption of our business, and diversion of our management's time and attention, to develop acquired products or technologies;

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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.

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

Delays or failures in the completion of clinical trials for our product candidates could significantly raise our product development costs.

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• Difficulties obtaining IRB or ethics committee approval to conduct a trial at a prospective site;

RISK FACTORS.

• Delays in reaching or failure to reach agreement on acceptable terms with prospective trial sites and investigators, the contractual terms of which can be subject to extensive negotiation and may vary significantly from site to site;

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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

RISK FACTORS.

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 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, 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, then 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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• regulatory authorities may require additional warnings or a narrowing of the indication on the product label;

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Any of these events could prevent us from achieving or maintaining the commercial success of our products and product candidates and could substantially increase commercialization costs.

We may not obtain or maintain the benefits associated with Orphan Drug Designation, including market exclusivity.

We may not obtain or maintain the benefits associated with designation as an orphan drug under the Orphan Drug Act, including market exclusivity.

Regulatory authorities in the United States may designate drugs for relatively small patient populations as orphan drugs.

The FDA may grant Orphan Drug Designation to drugs intended to treat a rare disease or condition that affects fewer than 200,000 individuals annually in the U.S.

The FDA may grant Orphan Drug Designation to drugs or biological products intended to prevent, diagnose, or treat a rare disease or condition that affects fewer than 200,000 individuals in the U.S.

Orphan drug designation entitles a party to financial incentives, such as opportunities for grant funding towards clinical trial costs, tax credits for certain research, and user fee waivers under certain circumstances.

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This implies that the FDA may not approve any other firm's application for the same drug for that same indication for a period of seven years.

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

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.

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

Although historically we have been granted orphan drug designation under the Orphan Drug Act for certain drug products and product candidates, 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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for seven years.

Even if we obtain exclusivity, the FDA could subsequently approve an alternative drug for the same condition if the FDA concludes that the second to reach the market is clinically superior in that it is safer, more effective, or makes a major contribution to patient care.

Even if we obtain exclusivity, the FDA could subsequently approve an alternative drug for the same condition if the FDA concludes that the second to reach the market is clinically superior by being safer or more effective, or by it making a major contribution to patient care.

In addition, a competitor may receive approval of different products for the same indication for which our orphan product has exclusivity or may obtain approval for the same product but for a different indication for which the orphan product has exclusivity.

In August 2017, the FDA Reauthorization Act of 2017 (FDARA) was enacted.

FDARA, among other things, codified the FDA's pre-existing regulatory interpretation to require that a drug sponsor demonstrate clinical superiority of an orphan drug that is otherwise the same as a previously approved drug for the same rare disease in order to receive orphan drug exclusivity.

The new legislation reverses prior precedent holding that the Orphan Drug Act unambiguously requires that the FDA recognize the orphan exclusivity period, regardless of showing clinical superiority.

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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

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any changes might affect our business.

It is uncertain how 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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and certain states have shown significant, increased interest in pursuing healthcare reform and changes to the healthcare delivery system.

Numerous major markets outside the US, including the EU, Japan, and China, have widespread governmental involvement in healthcare funding, including with regard to pricing and reimbursement of pharmaceuticals.

Numerous major markets outside the U.S., including the EU, Japan, and China, have widespread governmental involvement in healthcare funding, including with regard to pricing and reimbursement of pharmaceuticals.

RISK FACTORS.

Government-adopted reform measures could adversely impact the pricing of healthcare products and services in the U.S.

or internationally, adversely impacting the level of reimbursement available from governmental agencies and/or commercial third-party payors.

or internationally, adversely impact the level of reimbursement available from governmental agencies and/or commercial third-party payors.

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

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Executive branch, Congress, and state legislatures.

In March 2010, a comprehensive change to the U.S.

healthcare system, known as the Patient Protection and Affordable Care Act of 2010 (ACA) was enacted, as amended by the Health Care and Education Reconciliation Act of 2010.

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