What changed in this filing

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Item 7. Management’s Discussion and Analysis

2026-03-02 compared with 2025-02-25 · 227 added, 165 removed, 256 unchanged (60% of the section changed)

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rights to market and sell GOCOVRI and Osmolex ER.

Sage Therapeutics, LLC, a wholly-owned indirect subsidiary of Supernus Pharmaceuticals, Inc., has granted Supernus Pharmaceuticals, Inc.

a license to market and sell zuranolone in the United States.

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

Our diverse neuroscience portfolio includes approved treatments for 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.

Our 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.

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

2025 Acquisition of Sage Therapeutics, Inc.

(Sage) and Reorganization

On July 31, 2025, the Company completed its previously announced acquisition of Sage when Saphire, Inc., a Delaware corporation and wholly owned subsidiary of the Company (Purchaser), was merged with and into Sage (the Merger), with Sage continuing as the surviving corporation in the Merger as a wholly owned subsidiary of the Company (the Sage Acquisition).

At the time of the Sage Acquisition, Sage had an established commercial product in its portfolio, ZURZUVAE.

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

was reorganized into Sage Therapeutics, LLC.

We have a portfolio of commercial products and product candidates.

Commercial Products

• Qelbree ® (viloxazine) extended-release capsules is a novel non-stimulant product indicated for the treatment of ADHD in adults and pediatric patients 6 years and older.

• Qelbree ® (viloxazine) extended-release capsules are a novel non-stimulant product indicated for the treatment of ADHD in adults and pediatric patients 6 years and older.

The United States Food and Drug Administration (FDA) approved Qelbree for the treatment of ADHD in pediatric patients 6 to 17 years of age in April 2021, and in adult patients in April 2022.

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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 with PD experiencing "OFF" episodes.

• Oxtellar XR ® (oxcarbazepine) is indicated as therapy for the treatment of partial onset seizures in patients 6 years of age and older.

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

• 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 with PD experiencing "OFF" episodes.

• ONAPGO TM (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.

• ZURZUVAE ® (zuranolone) 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, 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.

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

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It is also indicated for the prophylaxis of migraine headache in adults and adolescents 12 years and older.

• Oxtellar XR ® (oxcarbazepine) is indicated as therapy for the treatment of partial onset seizures in patients 6 years of age and older.

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

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

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It is the only botulinum toxin type B available on the market.

• ONAPGO TM (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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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 and has received Orphan Drug Designation for several epilepsy indications from the FDA.

SPN-817 is in clinical development.

SPN-820 (NV-5138)

SPN-820 is a first-in-class, orally active small molecule that increases the brain mechanistic target of rapamycin complex 1 (mTORC1) mediated synaptic function intracellularly.

SPN-820 does not bind to or modulate any cell surface receptors and therefore is unlikely to have abuse potential given lack of binding to targets implicated in drug abuse.

In addition, unlike leucine, it is not incorporated into proteins during protein synthesis, and therefore, it is more available at the target site in the brain than leucine.

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.

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 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.

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

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

Qelbree Highlights

• The FDA has approved an update for the label for Qelbree to include new pharmacodynamic data.

The updated label highlights Qelbree’s partial agonist activity at the serotonin 5-HT2C receptor and inhibition of the norepinephrine transporter, reinforcing its multimodal pharmacodynamic profile.

Additionally, the updated label now includes new

lactation data for breastfeeding women with attention-deficit/hyperactivity disorder (ADHD), showing that the transfer of Qelbree into breastmilk is low.

• The Company recently presented interim results from an open-label Phase IV trial with Qelbree in 161 adults with ADHD and mood symptoms at the 30th Annual National Psychopharmacology Update™ conference.

The improvements in clinician and patient-rated measures of ADHD, depression and anxiety symptoms in the interim data analysis, analyzed for the first 95 patients who completed the trial, are encouraging and suggest that Qelbree's effects may extend to adults with complex ADHD.

Efficacy and safety outcomes were consistent with the double-blind, pivotal trial of Qelbree in adult ADHD.

Topline results from the full Phase IV trial (all 161 adults) are consistent with the interim results and will be presented at the American Psychiatric Association Annual Meeting in May 2025.

• Total IQVIA prescriptions for Qelbree were 767,791 for full year 2024, an increase of 25% compared to full year 2023.

• The Company received a two-plus year patent term extension from the US Patent and Trademark Office for US Patent number 9,662,338 that covers Qelbree.

This extends the original expiration date of the patent to the year 2035.

The Company 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.

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, zuranolone received Health Canada Authorization in Canada for treatment indicated for adults with PPD.

Also 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.

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

Product Pipeline Update

ONAPGO (formerly SPN-830) (apomorphine infusion device) for treatment of Parkinson's disease (PD)

• The Company announced in early February 2025 that the FDA approved ONAPGO (apomorphine hydrochloride), 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.

ONAPGO will be launched in the second quarter of 2025 with a support team of experts, including a robust nurse education program, and access support.

SPN-817 – Novel first-in-class highly selective AChE inhibitor for epilepsy

• In November 2024, the Company reported topline results from an open label Phase 2a study in patients with treatment-resistant seizures.

The study suggested a differentiated profile, with strong efficacy in focal seizures at the 3mg to 4mg twice daily doses.

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

• The Company has initiated a Phase 2b randomized, double-blind, placebo-controlled study of 3mg and 4mg twice daily doses with a targeted enrollment of approximately 258 adult patients with treatment resistant focal seizures.

• The Phase 2b randomized, double-blind, placebo-controlled study of 3mg and 4mg twice daily doses is ongoing with a targeted enrollment of approximately 258 adult patients with treatment resistant focal seizures.

SPN-820 – Novel first-in-class molecule that increases mTORC1 mediated synaptic function for depression

• 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).

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 Company will continue to analyze the data and decide on the future of the program.

SPN-443 – Novel stimulant for ADHD/CNS

• The Company completed a Phase 1 pharmacokinetic study of two oral formulations in healthy adults.

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

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

SPN-443 – Novel stimulant for attention-deficit/hyperactivity disorder (ADHD)

• The Company expects to initiate a Phase 1 single-ascending/multiple-ascending dose study in adult healthy volunteers in the second half of 2026.

Critical Accounting Policies and the Use of Estimates

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• Revenue recognition;

• Impairment of Indefinite-Lived Intangible Assets;

• Business combination and valuation of acquired assets;

• Valuation of contingent consideration;

• Impairment of definite-lived intangible assets

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Sales of our products are not subject to a general right of return;

however, we will accept return of expired product 6 months prior to, and up to 12 months subsequent to, the product's expiry date for certain products.

however, we will accept return of expired product 6 months prior to, and up to twelve months subsequent to, the product's expiry date for certain products.

Our products have a shelf life of up to 48 months from date of manufacture.

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The Company launched Qelbree in May 2021.

The Company is actively monitoring returns activity in light of the timeline

from the date of sale and the time at which we issue credit for expired products.

We had favorable actual returns in 2024 for

Qelbree and as a result, the Company changed its estimated provision for Qelbree product returns based on the most recent

The Company is actively monitoring returns activity in light of the timeline from the date of sale and the time at which we issue credit for expired products.

We had favorable actual returns in 2024 and 2025 for Qelbree and as a result, the Company changed its estimated provision for Qelbree product returns based on the most recent experience.

The Company has entered into settlement and license agreements with third parties, permitting the sale of a generic version of Trokendi XR beginning in January 2023.

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The entry of a generic competitor may cause our future Trokendi XR and Oxtellar XR product return rates to change from historical trends, and this change could have a material effect on the future provision for product returns.

Historically, we have experienced changes in estimates in return reserve calculations, but those adjustments have not been material to net earnings.

Historically, we have experienced changes in estimates in return reserve calculations, but those adjustments have not been material to net earnings (loss).

Adjustments related to prior year sales for product returns in 2025 and 2024 was less than 4% of net product sales for each respective period and was less than 1% of net product sales in 2023.

However, given the extensive number of inputs and assumptions, described above, future changes in our return reserves could be material.

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We evaluate inventory data reported by wholesalers, available prescription volume information, product pricing, historical experience and other factors in order to determine the adequacy of our accruals.

We regularly monitor our

accruals and record adjustments when rebate trends, rebate programs and contract terms, legislative changes, or other significant events indicate that a change in reserve is appropriate.

Historically, adjustments to rebate accruals have not been material to net earnings.

We regularly monitor our accruals and record adjustments when rebate trends, rebate programs and contract terms, legislative changes, or other significant events indicate that a change in reserve is appropriate.

Historically, adjustments to rebate accruals have not been material to net earnings (loss).

Specifically, a significant portion of rebates we pay are on state Medicaid programs.

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Estimates associated with our participation in state Medicaid programs are particularly susceptible to adjustment given the extensive time lag.

Historically, adjustments to rebate accruals have not been material to net earnings, but there continues to be an extensive time lag related to certain programs that could result in variability in future periods.

Historically, adjustments to rebate accruals have not been material to net earnings (loss), but there continues to be an extensive time lag related to certain programs that could result in variability in future periods.

For a roll-forward of the accrued sales deductions, see the section entitled Results of Operations - Revenues - Sales deductions and related accruals .

Impairment of Indefinite-Lived Intangible Assets

In 2020, t he Company acquired the right to further develop and commercialize SPN-830 (apomorphine infusion device), a late-stage product candidate (IPR&D intangible asset).

The In Process Research and Development (IPR&D) intangible asset represents the estimate of the fair value of acquired technology which has not yet reached technological feasibility.

The primary basis for determining the technological feasibility is obtaining specific regulatory approvals.

IPR&D is accounted for as an indefinite-lived intangible asset until completion or abandonment of the IPR&D project.

Upon completion of the development project, the IPR&D will be amortized over its estimated useful life.

We review intangible assets with indefinite lives f or impairment annually or more often if impairment indicators are identified.

Our annual evaluation is generally based on an assessment of qualitative factors to determine whether it is more likely than not the fair value of the asset is less than its carrying amount.

If the Company is unable to conclude that the indefinite-lived intangible asset is not impaired during its qualitative assessment, the Company will perform a quantitative assessment by estimating the fair value of the indefinite-lived intangible asset and comparing the fair value to the carrying amount.

The significant inputs and assumptions used to estimate the fair value of the IPR&D intangible asset include:

the timing and probability of success of clinical and regulatory approvals for the IPR&D asset, the estimated future cash flows from product sales, and the timing and projection of costs and expenses.

We believe that the timing and probability of success of clinical and regulatory approval for the IPR&D asset is key and directly drives the timing and realization of the estimated future cashflows from product sales and the incurrence of costs and expenses.

The drug regulatory approval process is inherently uncertain, lengthy, and difficult.

The FDA has substantial discretion in the drug approval process, including the ability to delay, limit or deny approval of a product candidate for many reasons.

In addition, the actual review and approval process time required may vary substantially based upon the type, complexity, and novelty of the product or disease.

Any adverse action by the FDA can potentially impact our estimated fair value of the IPR&D intangible asset.

As of December 31, 2024, we considered the positive results of clinical trials, industry benchmarks, available market data, and recent communications with the FDA regarding SPN-830 in determining the probability of technical and regulatory success input and assumption.

The carrying amount of the indefinite-lived intangible asset was $124.0 million as of December 31, 2024.

Although we believe the assumptions, judgments, and estimates we have used in our assessm ents are reasonable and appropriate, a material change in any of our assumptions or external factors could have lead to impairment charges.

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

Business Combinations and Valuation of Acquired Assets

The Company completed the Sage Acquisition on July 31, 2025.

The transaction was accounted for as a business combination.

The acquisition method of accounting requires that we recognize the assets acquired and liabilities assumed at their acquisition date fair values.

Goodwill is measured as the excess of consideration transferred over the acquisition date net fair values of the assets acquired and the liabilities assumed.

The purchase price allocation is a critical accounting policy because the estimation of fair values of acquired assets and assumed liabilities is judgmental and requires various assumptions.

Further, the amounts and useful lives assigned to depreciable and amortizable assets versus amounts assigned to goodwill, which is not amortized, can significantly affect the results of operations in the period of and for periods subsequent to a business combination.

Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction, and therefore represents an exit price.

When identifiable intangible assets, are acquired, we determine the fair values of the assets as of the acquisition date.

An income approach, which generally relies upon projected cash flow models, is used in estimating the fair value of the acquired intangible assets.

These cash flow projections are based on management's estimates of economic and market conditions including:

the estimated future cash flows from revenues of acquired assets;

the timing and projection of costs and expenses, discount rates;

and tax rates.

While we use our best estimates and assumptions as part of the process to value assets acquired and liabilities assumed at the acquisition date, our estimates are inherently uncertain and subject to refinement.

During the measurement period, which occurs before finalization of the purchase price allocation, changes in assumptions and estimates that result in adjustments to the fair values of assets acquired and liabilities assumed, if based on facts and circumstances existing at the acquisition date, are recorded on a retroactive basis as of the acquisition date, with the corresponding offset to goodwill.

Any adjustments not based on facts and circumstances existing at the acquisition date, or if subsequent to the conclusion of the measurement period, will be recorded to our consolidated statements of earnings.

Refer to Note 3, Sage Acquisition , for further information.

Valuation of Contingent Consideration

We record contingent consideration resulting from a business combination at its fair value on the acquisition date.

During the measurement period, if we obtain new information regarding facts and circumstances that existed as of the Sage Acquisition Closing Date that, if known, would have resulted in revised estimates of fair values of acquired assets, assumed liabilities or contingent consideration, the Company will accordingly revise its estimates of fair values and purchase price allocation.

In addition, on a quarterly basis, we will revalue the contingent consideration liability and record increases or decreases in their fair value as an adjustment to operating earnings.

The determination of the initial and subsequent value of the contingent consideration liability requires significant judgment by management.

Changes in any of the inputs not related to facts and circumstances existing as of the acquisition date may result in a significant fair value adjustment, which can impact the results of operations in the period in which the adjustment is made.

As of December 31, 2025 and December 31, 2024 the Company reported contingent consideration liability of $31.3 million and $47.3 million, respectively, in its consolidated balance sheets related to the Sage Acquisition, USWM Acquisition, and Adamas Acquisition.

There was no contingent consideration liability related to the USWM Acquisition and Adamas Acquisition as of December 31, 2025.

The Sage contingent consideration liability was $11.4 million as of the Sage acquisition date, and $31.3 million as of December 31, 2025.

The contingent consideration is primarily associated with the fair value of the regulatory and commercial milestone and the sales-based milestones contingent consideration payments.

The contingent consideration is related to one non-tradable contingent value right (CVR) which represents the contractual right to receive a contingent payment upon the achievement of the applicable regulatory and commercial milestone and sales-based milestones.

The estimated fair value of the contingent consideration was determined using the Monte Carlo simulation.

The key assumptions considered in estimating the fair value includes the estimated probability and timing of milestone achievement, such as the probability and timing of obtaining regulatory approval and first commercial sale in Japan, the estimated amount and timing of projected revenues, volatility, estimated discount rates and risk-free interest rate.

The drug regulatory approval process is inherently uncertain, and any adverse action taken by the Pharmaceuticals and Medical Devices Agency in Japan can potentially impact our estimated fair value of the regulatory and commercial activities milestone.

The possible outcomes for the contingent consideration range from $0 to $234 million on an undiscounted basis.

Refer to Note 3, Sage Acquisition , and Note 7, Contingent Consideration , for further information.

Subsequent to the Sage Acquisition, in December 2025, Shionogi, the Company's collaboration business partner, announced that it obtained manufacturing and marketing approval in Japan for ZURZUVAE ® Capsules 30 mg for the indication of depression and depressive state.

As a result, the Company's contingent consideration liability increased as of December 31, 2025.

Impairment of Definite-Lived Intangible Assets

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The primary inputs and assumptions used in the model included timing and projections of estimated future revenues and cash flows, loss of exclusivity, and discount rate.

If the carrying amount of the asset exceeds its fair value, the Company writes down the asset to its estimated

fair value, and an impairment loss equal to the difference between the assets fair value and carrying value is recognized in the consolidated statement of earnings in the period at which such determination is made.

If the carrying amount of the asset exceeds its fair value, the Company writes down the asset to its estimated fair value, and an impairment loss equal to the difference between the assets fair value and carrying value is recognized in the consolidated statement of earnings (loss) in the period at which such determination is made.

The use of different assumptions could increase or decrease the estimated fair value of assets and could therefore affect any impairment measurement.

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Trokendi XR 42,421 63,201 (20,780) (33) %

ONAPGO 17,254 — 17,254 100 %

26,912 29,008 (2,096) (7) %

Total net product sales $ 626,536 $ 637,696 $ (11,160) (2) %

Collaboration revenue (ZURZUVAE) 52,996 — 52,996 100 %

Royalty, licensing, and other revenues 39,420 24,121 15,299 63 %

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Net Product Sales

Net product sales increased by $63.8 million from $573.9 million in 2023 to $637.7 million in 2024.

The increase was primarily due to increases in net product sales from Qelbree and GOCOVRI partially offset by the decline in net product sales of Trokendi XR and Oxtellar XR due to generic erosion.

Net product sales decreased by $11.2 million from $637.7 million in 2024 to $626.5 million in 2025.

The decrease was primarily due to the decline in net product sales of APOKYN due to lower volume, and decline in net product sales of Oxtellar XR and Trokendi XR due to generic erosion, partially offset by the increases in net product sales from Qelbree and GOCOVRI due to higher volume and higher price, and ONAPGO, which was launched in the second quarter of 2025.

On November 4, 2025, we announced that due to stronger than expected demand for ONAPGO, supplier constraints are impacting our ability to fully meet this demand.

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

by a third-party contract manufacturing organization.

We currently rely on single source suppliers to produce and package final dosage forms for ONAPGO.

On February 24, 2026, we announced that we have made progress in 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.

A change in any of the suppliers would require regulatory approval which could cause a further delay in manufacturing and a possible loss of sales, which could affect future operating results adversely.

Sales Deductions and Related Accruals

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Both amounts are generally affected by changes in gross product sales, changes in the provision for net product sales deductions, and the timing of payments/credits.

The following table provides a summary of activities with respect to accrued product returns and rebates for the years ended December 31, 2024 and 2023 (dollars in thousands):

The following table provides a summary of activities with respect to accrued product returns and rebates and sales discounts for the years ended December 31, 2025 and 2024 (dollars in thousands):

Accrued Product Returns and Rebates

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Balance at December 31, 2024 $ 53,375 $ 115,330 $ 12,347 $ 181,052

Provision for current year sales 17,677 389,842 69,589 477,108

Adjustments relating to prior year sales (11,943) (2,049) (42) (14,034)

Provision related to:

Current year sales 10,563 433,223 72,982 516,768

Prior year sales (20,727) (389) 40 (21,076)

Total provision (10,164) 432,834 73,022 495,692

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Balance at December 31, 2023 $ 57,290 $ 96,984 $ 10,719 $ 164,993

Provision for current year sales 22,928 406,329 65,896 495,153

Adjustments relating to prior year sales (213) 1,672 31 1,490

Provision related to:

Current year sales 17,677 389,842 69,589 477,108

Prior year sales (11,943) (2,049) (42) (14,034)

Total provision 5,734 387,793 69,547 463,074

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The accrued product returns balance decreased from $53.4 million as of December 31, 2024 to $37.8 million as of December 31, 2025.

This decrease was primarily due to $11.9 million of adjustments in the estimated provision for product returns related to prior year sales offset by higher net product sales and timing of related return activity.

The majority of the adjustment is attributable to Qelbree, reflecting favorable actual returns experienced in 2024.

This decrease was primarily due to a decrease of $20.7 million of estimated provision for product returns related to prior year sales.

The majority of the provision for product returns related to prior year sales is attributable to Qelbree, reflecting continued favorable actual returns experienced in 2025.

As a result, the Company changed its estimated provision for product returns based on the most recent experience.

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The provision for product returns decreased from $5.7 million in 2024 to $(10.2) million in 2025.

The decrease was primarily due to the aforementioned $11.9 million of adjustments in the estimated provision for product returns related to prior year sales.

The provision for product rebates decreased from $408.0 million in 2023 to $387.8 million in 2024.

The decrease was primarily attributable to lower Trokendi XR sales and favorability in commercial programs, partially offset by higher Qelbree gross sales.

The decrease was primarily due to the aforementioned $20.7 million of favorable adjustment in the estimated provision for product returns related to prior year sales.

The provision for product rebates increased from $387.8 million in 2024 to $432.8 million in 2025.

The increase was primarily attributable to higher Qelbree sales and unfavorability in government programs as a result of product price increases in the first quarter of 2025.

Sales Discounts

The provision for sales discounts increased from $65.9 million in 2023 to $69.5 million in 2024 primarily attributable to higher net product sales in 2024 compared to 2023.

The provision for sales discounts increased from $69.5 million in 2024 to $73.0 million in 2025 primarily attributable to new product launched in 2025 and higher Qelbree sales in 2025 compared to 2024.

Adjustments related to prior year sales

Adjustments related to prior year sales in 2024 of $14.0 million was less than 3% of both net product sales and total provision for the year ended December 31, 2024.

As aforementioned, the majority of this adjustment is attributable to Qelbree, reflecting favorable actual returns experienced in 2024 for Qelbree.

Adjustments related to prior year sales in 2025 of $21.1 million was approximately 4% of both net product sales and total provision for the year ended December 31, 2025.

Adjustments related to prior year sales in 2024 of $14.0 million was less than 3% of both net product sales and total provision for the year ended December 31, 2024.

As aforementioned, the majority of this adjustment is attributable to Qelbree, reflecting favorable actual returns experienced in 2025 and 2024.

Collaboration Revenue (ZURZUVAE)

Collaboration revenue (ZURZUVAE) was $53.0 million for the year ended December 31, 2025.

The increase was due to the Sage Acquisition in July 2025.

Royalty, Licensing and Other Revenues

Royalty, licensing and other revenues decreased by $9.5 million from $33.6 million in 2023 to $24.1 million in 2024, primarily due to lower royalties on generic Trokendi XR due to the increased number of generic entrants.

Cost of Goods Sold

The following table provides information regarding our cost of goods sold for the years indicated (dollars in thousands):

Royalty, licensing and other revenues increased by $15.3 million from $24.1 million in 2024 to $39.4 million in 2025, primarily due to an increase in licensing revenues related to the achievement of a regulatory milestone under our collaboration agreement with Shionogi.

The royalty term for Orenitram is expected to cease in 2027 which may result in a future decrease to royalty revenues.

Cost of Revenues

The following table provides information regarding our cost of revenues for the years indicated (dollars in thousands):

Year Ended December 31,

2025 2024 Amount Percent

Cost of goods sold $ 77,906 $ 83,779 $ (5,873) (7)%

Cost of goods sold includes the cost of royalties;

Cost of revenues

$ 74,562 $ 77,906 $ (3,344) (4)%

Cost of revenues includes the cost of royalties;

cost of materials, including active pharmaceutical ingredients (API);

and cost to manufacture, including tableting, packaging, personnel, overhead, stability testing, and distribution.

Cost of goods sold decreased from $83.8 million in 2023 to $77.9 million in 2024.

The decrease was primarily driven by manufacturing efficiencies of Qelbree and the decline in net product sales of Trokendi XR and Oxtellar XR due to generic erosion.

Cost of revenues also includes our proportionate share of ZURZUVAE manufacturing costs under the Biogen Collaboration Agreement.

Cost of revenues decreased from $77.9 million in 2024 to $74.6 million in 2025.

The decrease was primarily driven by lower APOKYN royalties due to lower sales and decrease in Oxtellar XR sales due to generic erosion, primarily offset by increases in cost of revenues from Qelbree due to higher sales, increase in cost of revenues from ONAPGO, which was launched in the second quarter of 2025, and increase in manufacturing costs related to ZURZUVAE under the Biogen Collaboration Agreement from the acquisition of Sage in July 2025.

Research and Development Expense

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Research and development $ 106,235 $ 108,796 $ (2,561) (2)%

R&D expenses increased from $91.6 million in 2023 to $108.8 million in 2024.

The increase was primarily due to increased clinical program costs on SPN-817, SPN-820, the open-label study of Qelbree, and increased manufacturing costs of our product candidates.

R&D expenses decreased from $108.8 million in 2024 to $106.2 million in 2025.

The decrease was primarily due to decreased clinical program costs on SPN-820, partially offset by the increase in clinical program costs on SPN-817 and the Company's share of R&D expenses from the collaboration arrangement with Biogen.

The Company acquired a collaboration agreement with Biogen as part of the acquisition of Sage in July 2025.

Selling, General, and Administrative Expense

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Total $ 485,563 $ 321,582 $ 163,981 51%

Selling, general, and administrative expenses decreased from $336.4 million in 2023 to $321.6 million in 2024.

During the year ended December 31, 2024, the Company recorded approximately $14.2 million of insurance recoveries for certain legal costs.

Legal costs were recorded under general and administrative expense as incurred.

Correspondingly, the insurance recoveries were recorded as a reduction to general and administrative expenses.

There were no insurance recoveries recorded in 2023.

Selling and marketing expenses increased from $227.3 million in 2024 to $288.7 million in 2025.

The increase was primarily due to higher professional and consulting expenses, higher employee-related expenses due to an increase in headcount because of the acquisition of Sage, higher marketing expense related to ONAPGO, which was launched in second quarter of 2025, and the Company's share of commercial expenses from the collaboration arrangement with Biogen in 2025.

General and administrative expenses increased from $94.3 million in 2024 to $196.9 million in 2025.

The increase was primarily due to the acquisition-related costs associated with the acquisition of Sage in July 2025.

The one-time acquisition-related costs consist primarily of transaction costs of $10.0 million, post-combination employee-related expenses of $38.3 million, and post-combination share-based compensation expense of $25.0 million associated with the acceleration of the vesting of certain Sage's equity awards under the terms of the Merger Agreement and change in value of contingent value rights of the portion of potential CVR payments to former Sage employees which are considered probable under the employee compensation accounting model as of the fourth quarter of 2025.

Amortization of Intangible Assets

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Amortization of intangible assets $ 89,456 $ 77,977 $ 11,479 15%

Amortization of intangible decreased from $82.4 million in 2023 to $78.0 million in 2024.

The decrease is primarily due to impairment charges on certain acquired intangible assets in the fourth quarter of 2023 which reduced amortization expense in fiscal year 2024, as well as on Oxtellar XR, which was fully amortized as of September 2024 and therefore, no further amortization expense was recognized in the fourth quarter of 2024.

Intangible Asset Impairment Charges

The following table provides information regarding the intangible asset impairment charges during the periods indicated (dollars in thousands):

Year Ended December 31,

2024 2023 Amount Percent

Intangible asset impairment charges $ — $ 20,189 $ (20,189) (100)%

In the fourth quarter of 2023, the Company recognized impairment charges of $20.2 million mainly due to the partial write-off of the carrying value of some of its acquired intangible assets, primarily XADAGO.

The primary factors that led to the impairment determinations were the following:

(1) the performance of the commercial products;

(2) forthcoming loss of exclusivity of XADAGO;

and (3) the change in the Company's future outlook of the brands.

No impairment of intangible assets was recognized during the year ended December 31, 2024.

Contingent Consideration Gain

The following table provides information regarding the contingent consideration gain during the periods indicated (dollars in thousands):

Amortization of intangible assets increased from $78.0 million in 2024 to $89.5 million in 2025.

The increase is primarily due to ONAPGO and ZURZUVAE intangible assets amortization expense in 2025 offset by amortization expense in 2024 for Oxtellar XR and Namzaric intangible assets, which were fully amortized in 2024.

Prior to the FDA approval of ONAPGO in February 2024, ONAPGO was previously accounted for as an indefinite-lived intangible asset not subject to amortization.

ZURZUVAE intangible asset was acquired as part of the Sage Acquisition in July 2025.

Contingent Consideration Loss (Gain)

The following table provides information regarding the Contingent consideration loss (gain) during the periods indicated (dollars in thousands):

Year Ended December 31,

2025 2024 Amount Percent

Contingent consideration gain

Contingent consideration loss (gain)

$ 25,419 $ (6,110) $ 31,529 (516)%

Contingent consideration was a gain for the years ended December 31, 2024 and December 31, 2023 of $6.1 million and $1.5 million, respectively.

The change of $4.6 million was primarily driven by the non achievement of the 2024 sales-based milestone associated with the Adamas Acquisition.

Contingent consideration was a loss of $25.4 million for the year ended December 31, 2025, and a gain of $6.1 million for the year ended December 31, 2024, respectively.

The change was primarily due to an increase in fair value of the Sage contingent consideration associated with the regulatory and commercial milestone with the approval of ZURZUVAE for the treatment of MDD in Japan in December 2025, and the accretion of the USWM contingent consideration liabilities to the full milestone payment amounts with the approval of ONAPGO by the FDA in February 2025.

Other Income (Expense)

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2025 2024 Amount Percent

Interest income & other income, net $ 16,204 $ 10,453 $ 5,751 55%

Interest expense — (1,321) 1,321 (100)%

Noncash interest expense on nonrecourse liability related to sale of future royalties — (562) 562 (100)%

Noncash interest expense on debt — (532) 532 (100)%

Interest and other income, net $ 13,253 $ 16,204 $ (2,951) (18)%

Total $ 13,253 $ 16,204 $ (2,951) (18)%

Other income (expense) was an income of $16.2 million in 2024 compared to an income of $8.0 million in 2023.

The increase was due to higher interest income on marketable securities largely driven by an overall higher investment balance in 2024 and no debt outstanding in 2024.

The interest expense recognized in 2023 was related to the 2023 Notes which were paid off in April 2023.

Income Tax Expense

The following table provides information regarding our income tax expense during the periods indicated (dollars in thousands):

Interest and other income, net decreased to $13.3 million in 2025 from $16.2 million in 2024.

The decrease was due to lower interest income on marketable securities largely driven by sale of marketable securities holdings of which the proceeds were used to partially fund the Sage Acquisition in July 2025.

Income Tax Expense (Benefit)

The following table provides information regarding our income tax expense (benefit) during the periods indicated (dollars in thousands):

Year Ended December 31, Change

2025 2024 Dollar Percent

Income tax expense $ 24,005 $ 1,453 $ 22,552 **

Effective tax rate 25 % 53 %

Income tax expense (benefit)

$ (10,480) $ 24,005 $ (34,485) (144)%

** Indicates calculation result is equal to or greater than 100%

Income tax expense was $24.0 million and $1.5 million for the years ended December 31, 2024 and December 31, 2023, respectively.

The 2024 income tax expense is primarily driven by an increase in pre-tax book income as compared to prior year.

The effective tax rate is impacted by benefits from research and development credits and capital losses that were mostly offset by an increase in the deferred tax asset valuation allowance for net operating losses and investments during the year.

The 2023 income tax expense and effective tax rate was primarily driven by near break even pre-tax book income.

The following table provides information regarding our net earnings during the periods indicated (dollars in thousands):

Effective tax rate 21 % 25 %

Income tax expense (benefit) was a benefit of $10.5 million and expense of $24.0 million for the years ended December 31, 2025 and December 31, 2024, respectively.

The 2025 income tax benefit is primarily driven by pre-tax book loss as compared to prior year.

The effective tax rate is impacted by the favorable effect of state taxes and the research and development credit, which is offset by the effect of expenses related to current and prior year transactions that are not deductible for tax purposes.

Included within transaction costs are payments to former employees of Sage which are not deductible for tax purposes.

Net Earnings (Loss)

The following table provides information regarding our Net earnings (loss) during the periods indicated (dollars in thousands):

Year Ended December 31,

2025 2024 Amount Percent

Net earnings $ 73,865 $ 1,316 $ 72,549 5,513%

The increase in net earnings was primarily due to the higher revenues in 2024 from Qelbree and GOCOVRI and lower total costs and expenses in 2024, as well as no intangible asset impairment charge in fiscal year 2024.

Net earnings (loss) $ (38,550) $ 73,865 $ (112,415) (152)%

The decrease in Net earnings (loss) was primarily due to higher amortization of intangible assets, higher selling, general, and administrative expenses, and higher contingent consideration loss as a result of the acquisition of Sage in 2025, offset by higher revenues.

Financial Condition, Liquidity and Capital Resources

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Financing activities 9,130 12,193 (3,063)

Net change in cash and cash equivalents $ (5,723) $ (18,066) $ 12,343

Net change in cash, cash equivalents, and restricted cash

$ 60,567 $ (5,723) $ 66,290

Operating Activities

Net cash provided by operating activities was $47.3 million in 2025 compared to $172.0 million in 2024.

The increase in cash flows provided by operating activities was primarily due to higher net income for the year ended December 31, 2024 compared to the same period in prior year, and changes in working capital which reflects the timing impacts of cash collections on receivables and settlement of payables.

The decrease in cash flows provided by operating activities was primarily due to the decrease in net earnings for the year ended December 31, 2025 as well as changes in working capital.

The Company reported a net loss of $38.6 million and net earnings of $73.9 million for the years ended December 31, 2025 and December 31, 2024, respectively.

The decline in earnings is principally due to higher costs and expense in 2025 primarily due to the Sage Acquisition in July 2025.

The Company recorded $72.9 million acquisition-related costs in 2025.

Investing Activities

Net cash used in investing activities was $189.9 million in 2024 compared to $268.7 million provided by investing activities in 2023.

The change was primarily due to an increase in cash outflows from purchases of marketable securities, partially offset by higher cash inflows from the maturities of marketable securities.

In 2023, proceeds from the maturities of investments in marketable securities were used to pay off the 2023 Notes.

Net cash provided by investing activities was $4.1 million in 2025 compared to $189.9 million used in investing activities in 2024.

The change was primarily due to the following:

• Net cash inflows from marketable securities activity were higher in 2025 compared to the same period in 2024 due to maturities of the marketable securities, whereby the proceeds were used to fund the Sage Acquisition in 2025 offset by

• Cash outflows related to the Sage Acquisition in 2025 (net of cash acquired) of $293.1 million.

Net cash used in investing activities in 2024 was primarily due to purchases of marketable securities, partially offset by higher cash inflows from the maturities of marketable securities.

Financing Activities

Net cash provided by financing activities was $12.2 million in 2024 compared to $397.9 million used in the same period in 2023.

The change was primarily due to the payment of the total principal amounts and remaining outstanding interest due on

the 0.625% Convertible Senior Notes in April 2023, partially offset by an increase in proceeds from issuance of common stock in 2024.

Cash, Cash Equivalents and Marketable Securities

Cash and cash equivalents, and marketable securities are as follows (dollars in thousands):

Net cash provided by financing activities was $9.1 million in 2025 compared to $12.2 million provided in the same period in 2024.

The change was primarily due to the payment of the USWM contingent consideration milestones, offset by higher proceeds from the issuances of common stock in 2025 due to exercising of stock options.

Cash, Cash Equivalents, Marketable Securities, and Restricted Cash

Cash and cash equivalents, marketable securities, and restricted cash are comprised of the following (dollars in thousands):

December 31, 2025 December 31, 2024

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Marketable securities 180,222 384,281

Long-term marketable securities — 16,617

Restricted cash 1,450 —

Total $ 310,120 $ 453,612

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funding for research and development of our product candidates;

and the additional funding to launch ONAPGO (apomorphine hydrochloride) injection, formerly known as SPN-830, which was approved by the FDA in February 2025.

ONAPGO will be launched in the second quarter of 2025.

the additional funding for the launch of ONAPGO, which was approved by the FDA in February 2025 and launched in April 2025, and the additional funding for the marketing of ZURZUVAE which was acquired as part of the Sage Acquisition in July 2025.

Our marketable securities were lower in 2025 than during 2024 as a portion of the marketable securities we held were sold to fund the Sage Acquisition.

The Company believes its balances of cash, cash equivalents and unrestricted marketable securities, which totaled $308.7 million as of December 31, 2025, along with cash generated from ongoing operations and continued access to debt markets, will be sufficient to satisfy its cash requirements over the next twelve months and beyond.

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Our operating lease commitments include leases of fleet vehicles, leases of certain facilities, including the lease of the current headquarters office and laboratory space.

As of December 31, 2024, we have fixed lease payment obligations of $40.0 million, with $8.2 million payable within twelve months.

As of December 31, 2025, we have fixed lease payment obligations of $47.0

million, with $12.4 million payable within twelve months.

Refer to Note 13, Leases in the Notes to the Consolidated Financial Statements in Part II, Item 8 of this report.

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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 in July 2025 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.

Milestone Payment Obligations from Acquisitions

The Company has contingent consideration milestones payable related to the Adamas Acquisition.

As of December 31, 2024, the remaining Milestone Payment is payable (subject to certain terms and conditions) upon the first occurrence of the

achievement of aggregate worldwide net sales of GOCOVRI in excess of $225 million during any consecutive twelve-month period ending on or before December 31, 2025 (Milestone 2025) and may only be achieved once.

As of December 31, 2024, the possible outcomes for the contingent consideration range, on an undiscounted basis, related to remaining 2025 Milestone is from $0 to $25 million.

We also have contingent consideration milestones payable related to the USWM Acquisition.

On February 18, 2022, the FDA accepted the SPN-830 NDA for review, and we paid the resulting $25 million milestone in the first quarter of 2022.

In addition, there are two other regulatory and developmental contingent consideration milestone payments:

the first is a $25 million milestone due upon the FDA's regulatory approval and $30 million upon commercial launch of SPN-830.

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.

ONAPGO will be launched in the second quarter of 2025.

As such, the Company paid the milestone related to the FDA's approval of the SPN-830 NDA in February 2025.

We expect the remaining regulatory and developmental milestones to become due and be paid in 2025.

As of December 31, 2025, no amounts are due from the contingent consideration milestone payable related to the Adamas Acquisition.

As of December 31, 2024, there was one remaining outstanding milestone, Milestone 2025.

Milestone 2025 (subject to certain terms and conditions and may only be achieved once) is payable upon the first occurrence of the achievement of aggregate worldwide net sales of GOCOVRI in excess of $225 million during any consecutive twelve-month period ending on or before December 31, 2025.

At December 31, 2025, Milestone 2025 was not met in 2025 and therefore is no longer outstanding nor payable.

We also had contingent consideration milestones payable related to the USWM Acquisition.

At December 31, 2024, there were two remaining outstanding milestones, one related to the approval of ONAPGO and the other related to the commercial launch of ONAPGO.

Both milestones were met in 2025 and the liability was accreted to the milestone amounts due resulting in the recognition of $7.7 million change in fair value of contingent consideration during 2025.

In February 2025, the Company paid the $25 million milestone related to the FDA's approval of ONAPGO in February 2025.

ONAPGO was launched in April 2025 and the $30 million milestone payment related to the commercial launch of ONAPGO, subject to certain holdbacks as permitted under the Sale and Purchase Agreement Relating to USWM Enterprises, LLC, dated April 28, 2020, by and between US WorldMeds Partners, LLC and Supernus Pharmaceuticals, Inc., (USWM Sale and Purchase Agreement) became due and payable.

Of the $30 million, the Company paid $2.3 million in the second quarter of 2025 and the remaining amount held was reclassified to Other current liabilities in the consolidated balance sheet as the milestone had been met but payment remains subject to certain holdbacks permitted under the USWM Sale and Purchase Agreement.

The Company paid $1.9 million of the principal amount held back in the third quarter of 2025.

The outstanding liability as of December 31, 2025 is $26.6 million, which included the principal amount held back and the interest.

During the third quarter of 2025, USWorldsMeds Partners, LLC filed a complaint in the Superior Court of the State of Delaware seeking payment for the withheld amount, plus interest, attorney's fees and costs.

See Part I Item 3 Legal Proceedings for further information on this matter .

The Company has contingent consideration milestones payable related to the Sage Acquisition.

As of December 31, 2025, all milestone payments remain outstanding and payable upon achievement.

Subject to the terms of the Sage CVR Agreement, $1.00 per share (equal to aggregate of $66.9 million) would be payable if in any calendar year between closing and end of 2027, annual net sales (as defined in the Sage CVR Agreement) of ZURZUVAE allocable to Supernus or any of its affiliates reach $250 million or more in the U.S., $1.00 per share (equal to aggregate of $66.9 million) would be payable if in any calendar year between closing and end of 2028, annual net sales (as defined in the Sage 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 (equal to aggregate of $66.9 million) would be payable if in any calendar year between closing and end of 2030, annual net sales (as defined in the Sage 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 (equal to aggregate of $33.4 million) 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.

As of December 31, 2025, the possible outcomes for the contingent consideration range, on an undiscounted basis, range from $0 to $234 million.

Further, with the Sage Acquisition in the third quarter of 2025, our investment balance decreased as marketable securities were sold to fund the acquisition of Sage.

Refer to Part II, Item 7 - Management's Discussion and Analysis of Financial Condition and Results of Operations and Management's discussion on Financial Condition, Liquidity and Capital Resources of this Annual Report on Form 10-K for the period ended December 31, 2025, and Note 1, Business Organization , in the Notes to the Consolidated Financial Statements in Part II, Item 8 of this Annual Report.

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

Biogen Collaboration Obligations

Pursuant to the Biogen Collaboration Agreement, we are jointly commercializing ZURZUVAE in the United States with Biogen.

We have a contractual obligation to share equally in all operating profits and losses arising from the sales of ZURZUVAE in the U.S.

Consequently, we are required to fund 50% of the development and commercialization expenses incurred for the U.S.

market, including 50% of the costs associated with non-discretionary FDA post-marketing requirements, such as required studies in adolescent populations.

To the extent that shared commercialization and development expenses exceed net revenues in any given period, we are obligated to make cash payments to fund our share of the operating loss.

While Biogen records net product sales for ZURZUVAE in the U.S., the collaboration necessitates a periodic reconciliation process to ensure the equal sharing of economics, which results in net expense reimbursement payments between the parties.

We may incur obligations to reimburse Biogen for our share of selling, general, and administrative expenses, and research and development expenses, in each case, when Biogen’s incurred costs exceed ours.

We are also currently responsible for the manufacturing supply chain for the collaboration.

This requires us to finance the costs of manufacturing active pharmaceutical ingredients (API) and bulk drug product for commercialization in territories outside of the United States other than Japan, the Republic of Korea and Taiwan (the Biogen Territory).

While Biogen is obligated to reimburse us for the costs of supply related to marketing and sales in the Biogen Territory, we are required to fund the initial cash payments to third-party contract manufacturing organizations prior to receiving reimbursement from Biogen.

These manufacturing activities result in working capital requirements that fluctuate based, in part, on Biogen’s long-term demand forecasts for sales in the Biogen Territory and will continue until such time as Biogen assumes manufacturing responsibilities for the Biogen Territory as permitted under the agreement.

Navitor Development Agreement

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

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.

Royalty Payments

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We have other obligations in which the timing, likelihood and, in some situations, the amount of such payments are not known, which include the following:

• any milestone payments which may become payable to third parties under license agreements or contractual agreements regarding our clinical trials, or those which may become payable upon achieving sales, regulatory, and developmental milestones per contractual agreements.

per contractual agreements.

• liabilities related to uncertain tax positions.

Due to uncertainties in the timing of potential tax audits, the timing and the amounts associated with the resolution of these positions is uncertain.

As such, we are unable to make a reasonably reliable estimate regarding the timing of payments beyond 12 months.

As such, we are unable to make a reasonably reliable estimate regarding the timing of payments beyond twelve months.

Off-Balance Sheet Arrangements

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

What changed 10-K

Item 7. Management’s Discussion and Analysis