SUPERNUS PHARMACEUTICALS, INC.
For the period ended Mar 31, 2026. Filed May 5, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 5, 2026
SUPN$26.16-2.2%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-06.
0001356576-25-000071
Item 2. Managements Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-05.
0001356576-26-000022
Item 2. Managements Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 150 previous paragraphs and 107 current paragraphs.
60 unchanged; 35 reworded; 11 added; 55 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 6 previous and 6 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (11)
Current report
Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies in the second half of 2026.
Current report
•ONAPGO net product sales were $8.4 million in the first quarter of 2026, reflecting resumption of new patient initiation in February 2026. Since the launch in April 2025, and through the end of April 2026, approximately 2,200 enrollment forms have been submitted by more than 645 prescribers. The Company expects to file a regulatory submission to the FDA for a second supplier for ONAPGO in the third quarter of 2026, with potential FDA approval for the second supplier by mid-year 2027.
Current report
A summary of our significant accounting policies is included in Note 2, Summary of Significant Accounting Policies of our audited consolidated financial statements included in the Annual Report on Form 10-K for the year ended December 31, 2025. There were no significant changes to the disclosures with respect to our critical accounting policies in our Annual Report on Form 10-K for the year ended December 31, 2025.
Current report
The provision for product returns increased to $1.2 million for the three months ended March 31, 2026 from $(2.3) million for the three months ended March 31, 2025. The increase was primarily due to aforementioned change in estimated provision for product returns based on the most recent experience, which was primarily attributable to Qelbree.
Current report
General and administrative expenses were $38.2 million and $26.7 million for the three months ended March 31, 2026 and 2025, respectively. The increase was primarily due to higher professional and consulting expenses, higher operating expenses related to ONAPGO, which was launched in the second quarter of 2025, and the Company's proportionate share of expenses from the collaboration arrangement with Biogen.
Current report
Contingent Consideration Loss
Current report
Other income (expense) was an income of $2.4 million and $4.4 million for the three months ended March 31, 2026 and 2025, respectively. The decrease was due to lower investment in marketable securities and lower market interest rates in 2026 compared to 2025. The cash consideration paid for the Sage acquisition was funded through the Company's cash, cash equivalents and marketable securities holdings.
Current report
Income Tax Expense (Benefit)
Current report
The Company has various potential milestone payments a result of the acquisition of Sage Therapeutics, Inc. On March 19, 2026, Shionogi announced the successful commercial launch of a product containing zuranolone for the treatment of MDD in Japan. As such, a milestone was met and became due and payable at that time. Refer to Note 7, Contingent Consideration, in the Notes to the Consolidated Financial Statements in Part I, Item 1, Unaudited Condensed Consolidated Financial Statements, of this Quarterly Report on Form 10-Q for discussion of contingent consideration associated with the Acquisition of Sage Therapeutics, Inc. for further details.
Current report
On January 22, 2026, the Company entered into a First Amendment (Amendment) to the Agreement and Plan of Merger (Agreement) dated September 12, 2018, with former Biscayne security holders. The Amendment relates to the timing and payment of certain milestones under the Biscayne merger agreement. The Company agreed to pay former Biscayne security holders $10.0 million, one of the milestones specified in the Agreement, by June 30, 2026.
Current report
Additionally, on April 1, 2026, the Company entered into an Asset Purchase Agreement with Navitor and consummated the transactions contemplated therein whereby the Company acquired, among other things, the right, title, materials, and intellectual property of SPN-820. The Company is obligated to effect and complete one Phase 2b study and make several milestone payments of up to $350 million contingent upon the achievement of specified development, regulatory and commercial milestones.
Removed paragraphs (55)
Previous report
2025 Acquisition of Sage Therapeutics, Inc. (Sage) and Reorganization
Previous report
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.
Previous report
Following the Sage Acquisition, during the third quarter of 2025, Sage Therapeutics, Inc. was reorganized into Sage Therapeutics, LLC.
Previous report
The Company plans to initiate a follow-on randomized double-blind placebo-controlled Phase 2b adjunctive trial in adults with major depressive disorder (MDD). For drugs that work through the mTORC1 pathway, emerging data indicates that chronic daily dosing may actively suppress sustained neuroplasticity and antidepressant benefits. Accordingly, the follow-on Phase 2b study will utilize intermittent dosing.
Previous report
•ONAPGO, the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson's disease, generated net product sales of $6.8 million in its first full quarter following U.S. commercial launch in April 2025. More than 1,300 enrollment forms were submitted by over 450 prescribers from launch through September 30, 2025.
Previous report
•Due to stronger than expected demand for ONAPGO, supplier constraints are impacting the Company's ability to fully meet this demand. As a result of this supply imbalance, the Company is prioritizing care for patients currently on ONAPGO. This requires pausing delivery to patients who have not started ONAPGO. The Company is working to build adequate inventory and resume new patient initiation as soon as possible, and will provide timely updates as progress is made in resolving this supply constraint.
Previous report
The significant accounting policies and basis of presentation for our condensed consolidated financial statements are described in Part I, Item 1, Financial Statements, Note 2, Summary of Significant Accounting Policies, in the Notes to the
Previous report
Condensed Consolidated Financial Statements. Our condensed consolidated financial statements are prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP), requiring us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, and expenses, and to disclose material contingent assets and liabilities. Actual results could differ materially from our estimates.
Previous report
We believe the judgments, estimates, and assumptions associated with the following critical accounting policies have the greatest potential impact on our condensed consolidated financial statements:
Previous report
•Revenue recognition;
Previous report
•Business combination and valuation of acquired assets;
Previous report
•Valuation of contingent consideration;
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•Impairment of definite-lived intangible assets
Previous report
Revenue Recognition
Previous report
Our principal source of revenue is product sales. Revenue from product sales is recognized when physical control of our products is transferred to our customers, who are primarily pharmaceutical wholesalers, specialty pharmacies, and distributors. Product sales are recorded net of various forms of variable consideration, including: estimated rebates; sales discounts; and an estimated liability for future product returns (collectively, "sales deductions").
Previous report
The variability in the net transaction price for our products arises primarily from the aforementioned sales deductions. Significant judgment is required in estimating certain sales deductions, including rebates and returns. In making these estimates, we consider: historical experience; product price increases; current contractual arrangements under applicable payor programs; unbilled claims; processing time lags for claims; inventory levels in the wholesale, specialty pharmacy, and retail distribution channel; and product life cycle. We adjust our estimates at the earlier of when the most likely amount of consideration we expect to receive changes, or when the consideration becomes fixed. Variable consideration on product sales is only recognized when it is probable that a significant reversal will not occur. If actual results in the future vary from our estimates, we adjust our estimates in the period identified. These adjustments could materially affect net product sales and earnings in the period in which the adjustment(s) is recorded. Refer to Part I, Item 1— Financial Statements, Note 2, Summary of Significant Accounting Policies, in the Notes to the Condensed Consolidated Financial Statements, for further discussion on each of the different sales deductions. While sales rebates have been relatively predictable based on historical experience such that there have not been material changes in estimates in prior periods, there have been critical estimates associated with rebates and returns that may result in significant variability as further discussed below.
Previous report
Returns
Previous report
We maintain a return policy that allows our customers to return products within a specified period of time. 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. Our products have a shelf life of up to 48 months from date of manufacture. The product return accrual is estimated principally based on historical experience, the level and estimated shelf life of inventory in the distribution channel, changes in the current wholesaler prices, our return policy and expected market events, including generic competition. The time lag from date of sale of our products when we accrue our provision for product
Previous report
returns and the time at which we issue credit for expired product can occur up to several years after the sale of our product. Estimates associated with our provision for product returns are particularly susceptible to adjustment given the extensive time lag. The Company launched Qelbree in May 2021. The Company is actively monitoring returns activity in light of the timeline
Previous report
from the date of sale and the time at which we issue credit for expired products. We had favorable actual returns in 2024 and year to date 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. In addition, 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. The Company is actively monitoring returns activity in light of the loss of exclusivity and actual and possible further future sales decline based on timing of generic entry. 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. However, given the extensive number of inputs and assumptions, described above, future changes in our return reserves could be material.
Previous report
Rebates
Previous report
Rebates are discounts which we pay under either public sector or private sector health care programs. Rebates paid under public sector programs are generally mandated under law, whereas private sector rebates are generally contractually negotiated by us with managed care providers. Both types of rebates vary over time. Rebate amounts are typically based upon the volume of purchases using contractual or statutory prices, which may vary by product and by payer. For each type of rebate, the factors used in the calculations of the accruals for that rebate include the identification of the products subject to the rebate, applicable price terms and estimated lag time between sale and payment of the rebate, which can be significant. In order to establish the rebate
Previous report
accruals, we use both internal and external data to estimate the level of inventory in the distribution channel and the rebate claims processing lag time for each type of rebate. To estimate the rebate percentage or net price, we track sales by product and by customer or payer. 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.
Previous report
Specifically, a significant portion of rebates we pay are on state Medicaid programs. We participate in state Medicaid programs wherein the lag time from the date of sale of our product when we accrue for provision for rebates and the ultimate invoicing by the individual state Medicaid program can occur up to several quarters after the sale of our product. Because of the time lag for Medicaid, in any particular quarter, our adjustments may incorporate revisions of accruals for prior periods. 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
Previous report
lag related to certain programs that could result in variability in future periods.
Previous report
For a roll-forward of the accrued sales deductions, see the section entitled Results of Operations - Revenues - Sales deductions and related accruals.
Previous report
Business Combinations and Valuation of Acquired Assets
Previous report
The Company completed the Sage Acquisition on July 31, 2025. The transaction was accounted for as a business combination. To determine whether the acquisition should be accounted for as a business combination or as an asset
Previous report
acquisition, the Company made certain judgments regarding whether the acquired set of activities and assets met the definition of a business. Judgment is required in assessing whether the acquired processes or activities, along with their inputs, would be substantive to constitute a business, as defined by U.S. GAAP.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
Refer to Note 3, Sage Acquisition, for further information.
Previous report
Valuation of Contingent Consideration
Previous report
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.
Previous report
As of September 30, 2025 and December 31, 2024 the Company reported contingent consideration liability of $11.4 million and $47.0 million, respectively, in its condensed consolidated balance sheets related to the Sage Acquisition, USWM Acquisition, and Adamas Acquisition.
Previous report
The Sage contingent consideration liability was $11.4 million as of September 30, 2025 is primarily associated with the fair value of the regulatory and commercial milestone and sale milestone contingent consideration payments. The key assumptions considered in estimating the fair value include the estimated probability and timing of milestone achievement, such as the probability and timing of obtaining regulatory approval in Japan. 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 these regulatory and commercial activities milestones. 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 milestones and sales-based milestones. The estimated fair value of the contingent consideration was determined using the Monte Carlo simulation. The key assumptions considered include the estimated amount and timing of projected cash flows, volatility, estimated discount rates and risk-free interest rate. 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.
Previous report
Impairment of Definite-Lived Intangible Assets
Previous report
Management assesses the potential impairment of our finite-lived intangibles whenever events or changes in circumstances indicate that the carrying value may not be recoverable. The carrying amount of the definite-lived intangible assets, net was $623.5 million as of September 30, 2025. Changes that could prompt such an assessment may include significant or adverse changes in the legal and regulatory environment, the introduction or advancement of competitive products and product candidates, changes in market demand, declining revenue and/or other events that indicate it is more likely than not that fair value is less than its carrying value. If a review of the definite-lived intangibles indicates that the carrying value of certain of these assets is more than the estimated undiscounted future cash flows, an impairment charge is made, as required, to adjust the carrying value to the estimated fair value. Evaluating for impairment requires judgment, including evaluating current economic and competitive circumstances, estimating future cash flows, future growth rates and future profitability. 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 (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. There were no impairment charges for the three and nine months ended September 30, 2025.
Previous report
The provision for product returns decreased to $(6.6) million for the three months ended September 30, 2025 from $8.3 million for the three months ended September 30, 2024. The decrease was primarily due to the aforementioned reduction of $16.3 million of estimated provision for product returns related to prior year sales.
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Reworded paragraphs (35)
Previous wording
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, 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.
Current wording
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, 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, attention deficit hyperactivity disorder (ADHD) and other CNS disorders.
Previous wording
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 is in clinical development and has received Orphan Drug Designation for several epilepsy indications from the FDA.
Current wording
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 is in clinical development.
Previous wording
•The Company plans to initiate a follow-on Phase 2b multi-center, randomized, double-blind, placebo-controlled trial in approximately 200 adults with major depressive disorder (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. The Company expects to initiate the Phase 2b study by the end of 2025.
Current wording
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.
Previous wording
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 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.
Current wording
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 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 plans to initiate Single
Previous wording
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). 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.
Current wording
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). Shionogi received approval for a product containing zuranolone for the treatment of MDD by the Pharmaceuticals and Medical Devices Agency in Japan in the fourth quarter of 2025, and announced commercial launch in the first quarter of 2026. No product containing zuranolone is approved for the treatment of MDD in the United States and neither the Company or Biogen are currently pursuing such approval for 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, a product containing zuranolone received Health Canada Authorization in Canada for treatment indicated for adults with PPD.
Previous wording
•Collaboration revenue from ZURZUVAE was $20.2 million in the third quarter of 2025, representing approximately two months of collaboration revenue reported by Supernus since the closing of the Sage Acquisition on July 31, 2025. Collaboration revenue (ZURZUVAE) represents 50% of the net revenues for ZURZUVAE recorded by Biogen Inc. Full third quarter 2025 U.S sales of ZURZUVAE, as reported by Biogen Inc., increased approximately 150% compared to the same period in 2024 and approximately 19% compared to the second quarter of 2025.
Current wording
•Collaboration revenue from ZURZUVAE was $27.6 million in the first quarter of 2026. Collaboration revenue represents 50% of the net revenues for ZURZUVAE recorded by Biogen Inc. First quarter 2026 U.S sales of ZURZUVAE, as reported by Biogen Inc., increased approximately 100% compared to the same period in 2025. The total number of prescriptions for ZURZUVAE increased by 82% in the first quarter of 2026 compared to the same period last year.
Previous wording
•Net sales of Qelbree increased 31% to $81.4 million in the third quarter of 2025, compared to the same period in 2024. Total IQVIA prescriptions for Qelbree were 238,770 for the third quarter 2025, representing an increase of 23% compared to the same period in the prior year.
Current wording
•Net sales of Qelbree increased 20% to $77.9 million in the first quarter of 2026, compared to the same period in 2025. Total IQVIA prescriptions for Qelbree were 254,824 for the first quarter 2026, representing an increase of 19% compared to the same period last year. The total number of prescribers reached an all-time high of approximately 43,000 in the first quarter of 2026.
Previous wording
•Net sales of GOCOVRI increased 15% to $40.8 million in the third quarter of 2025, compared to the same period in 2024, driven by growth in prescriptions and number of prescribers.
Current wording
•Net sales of GOCOVRI increased 15% to $35.2 million in the first quarter of 2026, compared to the same period in 2025. Total number of prescriptions grew by 7% in the first quarter of 2026 compared to the same period last year.
Previous wording
•The Company has selected ADHD as the lead indication for SPN-443 and expects to initiate a Phase 1 single-ascending/multiple ascending dose study in adult healthy volunteers in 2026.
Current wording
•The Company expects to initiate a Phase 1 single-ascending/multiple-ascending dose study in adult healthy volunteers in the second half of 2026.
Previous wording
Comparison of the Three and Nine Months ended Months Ended September 30, 2025 and 2024
Current wording
Comparison of the Three Months Ended March 31, 2026 and 2025
Previous wording
Revenues consist primarily of net product sales of our commercial products in the U.S., supplemented by royalty and licensing revenues from our collaborative licensing arrangements. The following table provides information regarding our revenues during the three and nine months ended months ended September 30, 2025 (dollars in thousands):
Current wording
Revenues consist primarily of net product sales of our commercial products in the U.S., supplemented by our collaboration revenue from the Biogen Collaboration Agreement and royalty and licensing revenues from our collaborative licensing arrangements. The following table provides information regarding our revenues during the three months ended March 31, 2026 (dollars in thousands):
Previous wording
(2)Includes the Company's proportionate share of sales of ZURZUVAE.
Current wording
(b)Includes the Company's proportionate share of sales of ZURZUVAE.
Previous wording
Net product sales were $168.5 million and $170.3 million for the three months ended September 30, 2025 and 2024, respectively. Net product sales were $468.5 million and $471.3 million for the nine months ended September 30, 2025 and 2024, respectively. The decrease in both periods 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.
Current wording
Net product sales were $150.8 million and $142.0 million for the three months ended March 31, 2026 and 2025, respectively. The increase was primarily due to 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, partially offset by 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.
Previous wording
Adjustments related to prior year sales for the nine months period ended September 30, 2025 is approximately 4% of net product sales. The majority of the adjustments is attributable to Qelbree, reflecting favorable actual returns experienced in 2025. As a result, the Company changed its estimated provision for product returns based on the most recent experience. Adjustments related to prior year sales for the nine months period ended September 30, 2024 was approximately 2% of net product sales. Refer to discussion Sales Deductions and Related Accruals below.
Current wording
Adjustments related to prior year sales for the three months ended March 31, 2026 were approximately 1% of net product sales. Adjustments related to prior year sales for the three months ended March 31, 2025 were approximately 5% of net product sales. In 2025, the Company had favorable actual returns experience and as a result, the Company changed its estimated provision for product returns based on the most recent experience. Adjustments related to prior year sales for the three months ended March 31, 2025 were primarily attributable to Qelbree. Refer to discussion Sales Deductions and Related Accruals below.
Previous wording
On November 4, 2025, the Company announced that due to stronger than expected demand for ONAPGO, supplier constraints are impacting the Company's 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 CMO. We rely on single source suppliers to produce and package final dosage forms for ONAPGO. A change in supplier would require regulatory approval which could cause a delay in manufacturing and a possible loss of sales, which could affect future operating results adversely.
Current wording
On November 4, 2025, we announced that due to stronger than expected demand for ONAPGO, supplier constraints were 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. In February 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, provided regulatory approval is obtained. Any changes 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.
Previous wording
We record accrued product returns and accrued product rebates as current liabilities in Accrued product returns and rebates, on our condensed consolidated balance sheets. We record sales discounts as a reduction against Accounts receivable, neton the unaudited condensed consolidated balance sheets. 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.
Current wording
We record accrued product returns and accrued product rebates as current liabilities in Accrued product returns and rebates, on our condensed consolidated balance sheets. We record sales discounts as a reduction against Accounts receivable, neton the condensed consolidated balance sheets. 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.
Previous wording
The accrued product returns balance decreased to $43.3 million as of September 30, 2025 from $57.4 million as of September 30, 2024. This decrease was primarily due to the $16.3 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 for Qelbree. As a result, the Company changed its estimated provision for product returns based on the most recent experience.
Current wording
The accrued product returns balance decreased to $37.2 million as of March 31, 2026 from $49.9 million as of March 31, 2025. This decrease was primarily due to favorable returns processed in 2025. During 2025, the Company had favorable actual returns experience. As a result, the Company changed its estimated provision for product returns based on the most recent experience. The provision for product returns related to prior year sales, which was $0.4 million and $7.0 million as of March 31, 2026 and 2025, respectively. The provision for product returns related to prior year sales was primarily attributable to Qelbree, reflecting continued favorable actual returns experienced in 2025.
Previous wording
The accrued product rebates balance increased to $141.2 million as of September 30, 2025 from $111.7 million as of September 30, 2024 primarily due to timing of payments associated with government programs.
Current wording
The accrued product rebates balance increased to $152.5 million as of March 31, 2026 from $120.2 million as of March 31, 2025 primarily due to timing of payments associated with government programs.
Previous wording
The provision for product rebates increased to $295.1 million for nine months ended September 30, 2025 from $293.6 million for the nine months ended September 30, 2024. The increase was primarily attributable to higher Qelbree sales and unfavorability in government programs as a result of product price increases in Q1 2025.
Current wording
The provision for product rebates increased to $124.1 million for the three months ended March 31, 2026 from $105.2 million for the three months ended March 31, 2025. The increase was primarily attributable to higher Qelbree, GOCOVRI, and ONAPGO sales.
Previous wording
Collaboration revenue (ZURZUVAE) was $20.2 million for the three months ended September 30, 2025 and for the nine months ended September 30, 2025. The increase was due to the Sage Acquisition in July 2025.
Current wording
Collaboration revenue (ZURZUVAE) was $27.6 million for the three months ended March 31, 2026. The increase was due to the Sage Acquisition in July 2025.
Previous wording
Royalty, licensing and other revenues were $3.4 million and $5.4 million for the three months ended September 30, 2025 and 2024, respectively. The decrease was primarily due to lower royalty revenues. Royalty, licensing and other revenues were $18.7 million and $16.4 million for the nine months ended September 30, 2025 and 2024, respectively. The increase was primarily due to an increase in licensing revenues related to the achievement of a milestone under a licensing agreement for Qelbree, and an increase in royalty revenues from Oxtellar XR. The Company entered into settlement and license agreements that allowed a third party to enter the Oxtellar XR market in September 2024.
Current wording
Royalty, licensing and other revenues were $29.3 million and $7.8 million for the three months ended March 31, 2026 and 2025, respectively. The increase was primarily due to an increase in licensing revenues related to the achievement of a milestone under the collaboration agreement with Shionogi.
Previous wording
Cost of revenues was $19.0 million and $17.6 million for the three months ended September 30, 2025 and 2024, respectively. The increase was primarily driven by increases in Qelbree due to higher sales and ONAPGO which was launched in the second quarter of 2025 partially offset by lower APOKYN royalties due to lower sales offset. Cost of revenues was $51.6 million and $51.8 million for the nine months ended September 30, 2025 and 2024, respectively. The decrease in was primarily driven by lower APOKYN royalties due to lower sales and decrease in Oxtellar XR sales due to generic erosion, principally offset by increases in Qelbree due to higher sales and ONAPGO, which was launched in the second quarter of 2025.
Current wording
Cost of revenues was $23.4 million and $15.8 million for the three months ended March 31, 2026 and 2025, respectively. The increase was primarily driven by higher costs of Qelbree due to increased sales, ONAPGO, which was launched in the second quarter of 2025, and higher manufacturing costs related to ZURZUVAE. These increases were partially offset by lower APOKYN royalties due to lower sales and lower Trokendi XR and Oxtellar XR costs, primarily due to generic erosion.
Previous wording
Research and Development (R&D) expenses were $29.4 million and $29.0 million for the three months ended September 30, 2025 and 2024, respectively. R&D expenses were $78.4 million and $80.1 million for the nine months ended September 30, 2025 and 2024, respectively. The decrease in the year to date period 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.
Current wording
Research and Development (R&D) expenses were $39.4 million and $26.9 million for the three months ended March 31, 2026 and 2025, respectively. The increase was primarily due to an increase in clinical program costs on SPN-817, which includes the $10.0 million expense to former Biscayne security holders, and the Company's share of R&D expenses from the collaboration arrangement with Biogen which was acquired through the Sage Acquisition in July 2025, partially offset by decreased clinical program costs on SPN-820.
Previous wording
Selling and marketing expenses were $77.1 million and $54.3 million for the three months ended September 30, 2025 and 2024, respectively. Selling and marketing expenses were $205.5 million and $172.7 million for the nine months ended September 30, 2025 and 2024, respectively. The increases in both periods were primarily due to higher professional and consulting expenses, higher employee-related expenses, 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.
Current wording
Selling and marketing expenses were $87.0 million and $63.3 million for the three months ended March 31, 2026 and 2025, respectively. The increase was primarily due to higher professional and consulting expenses, higher employee-related expenses, higher marketing expense related to ONAPGO, which was launched in the second quarter of 2025, and the Company's proportionate share of expenses from the collaboration arrangement with Biogen.
Previous wording
Amortization of intangible assets was $24.3 million and $19.5 million for the three months ended September 30, 2025 and 2024, respectively. Amortization of intangible assets was $64.9 million and $59.7 million for the nine months ended September 30, 2025 and 2024, respectively. The increase was 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. 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.
Current wording
Amortization of intangible assets was $25.6 million and $19.8 million for the three months ended March 31, 2026 and 2025, respectively. The increase was primarily due to ONAPGO and ZURZUVAE intangible assets amortization expense in the first quarter of 2026. ONAPGO was previously accounted for as an indefinite-lived intangible asset not subject to amortization until FDA approval in February 2025. ZURZUVAE intangible asset was acquired as part of the Sage Acquisition in July 2025.
Previous wording
Contingent consideration was a loss of $7.7 million and a gain of $6.5 million for the nine months ended September 30, 2025 and 2024, respectively. The change to loss for the nine months ended September 30, 2025 was primarily driven by 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.
Current wording
Contingent consideration loss was $2.4 million and $7.7 million for the three months ended March 31, 2026 and 2025, respectively. The contingent consideration loss for the first quarter of 2026 was primarily due to the accretion of a Sage CVR to the full milestone payment amount with the achievement of a regulatory milestone with the approval of ZURZUVAE for the treatment of MDD in Japan. For the first quarter of 2025, the loss was due to the accretion to the full milestone payment amount with the achievement of the USWM milestones. ONAPGO was approved by the FDA in February 2025 and was launched in April 2025.
Previous wording
Income tax benefit was $12.8 million (22.2% effective tax rate) and income tax expense was $12.7 million (26.9% effective tax rate) for the three and nine months ended September 30, 2025, as compared to an income tax expense of $6.4 million (14.3% effective tax rate) and $13.0 million (18.1% effective tax rate) for the three and nine months ended September 30, 2024. The change in income tax expense (benefit) in both periods was primarily due to decreased pre-tax book income for the three and nine months ended September 30, 2025, and higher forecasted earnings before taxes, as compared to the same periods in 2024.
Current wording
Income tax expense (benefit) was a benefit of $3.7 million (61.5% effective tax rate) for the three months ended March 31, 2026, as compared to an income tax expense of $6.0 million ((102.8)% effective tax rate) for the three months ended March 31, 2025. The change in income tax expense (benefit) and effective income tax rate was primarily due to an increase in forecasted full year pre-tax earnings (losses) and an increase in non-deductible expenditures for the three months ended March 31, 2026, as compared to the same period in 2025.
Previous wording
The Company's effective income tax rates for the three months ended September 30, 2025 varies from the statutory federal tax rate in the United States (U.S. federal tax rate) of 21% primarily due to state taxes and non-deductible transaction costs, offset by tax benefits related to research and development tax credits. The Company's effective income tax rates for the nine months ended September 30, 2025 varies from the statutory federal tax rate in the United States (U.S. federal tax rate) of 21% primarily due to state taxes and non-deductible transaction costs, offset by tax benefits related to a state tax refund and research and development tax credits. The Company's effective income tax rates for the three and nine months ended September 30, 2024 vary from the statutory U.S. federal tax rate primarily due to state taxes, offset by tax benefits related to research and development tax credits.
Current wording
The Company's effective income tax rate for the three months ended March 31, 2026 varies from the statutory federal tax rate in the United States (U.S. federal tax rate) of 21% primarily due to the effects of non-deductible executive compensation, non-deductible payments related to contingent consideration, and state taxes. The Company's effective income tax rate for the three months ended March 31, 2025 vary from the statutory U.S. federal tax rate primarily due to the impact of recurring permanent differences on a forecast near break-even loss.
Previous wording
The annual forecasted earnings represent the Company's best estimate as of September 30, 2025 and 2024, are subject to change and could have a material impact on the effective tax rate in subsequent periods. Accounting Standard Codification 740, Income Taxes (ASC 740), requires the Company to estimate the annual effective income tax rate for the full year and apply it to pre-tax income (loss) for each interim period, taking into account year-to-date amounts and projected results for the full year.
Current wording
The annual forecasted earnings represent the Company's best estimate as of March 31, 2026 and 2025, are subject to change and could have a material impact on the effective tax rate in subsequent periods. ASC 740, Income Taxes (ASC 740), requires the Company to estimate the annual effective income tax rate for the full year and apply it to pre-tax income (loss) for each interim period, taking into account year-to-date amounts and projected results for the full year.
Previous wording
The Company believes its balances of cash, cash equivalents, and unrestricted marketable securities, which totaled $281.2 million as of September 30, 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 12 months and beyond.
Current wording
The Company believes its balances of cash, cash equivalents, and unrestricted marketable securities, which totaled $384.2 million as of March 31, 2026, 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.
Previous wording
We have financed our operations primarily with cash generated from product sales, supplemented by revenues from royalty and licensing arrangements, as well as proceeds from the sale of equity and debt securities. Continued cash generation is highly dependent on the success of our commercial products, as well as the success of our product candidates if approved by the FDA. While we expect continued profitability in future years, we anticipate there may be significant variability from year to year in the level of our profits particularly due to continued market and payor pressures for our commercial products; the unfavorable impact of the loss of patent exclusivity for Trokendi XR in January 2023 and Oxtellar XR in September 2024; the potential unfavorable impact of the forthcoming loss of exclusivity of XADAGO; funding for research and development of our product candidates; 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. During the third quarter of 2025 our marketable securities were lower than during the third quarter of 2024 as a portion of the marketable securities we held were sold to fund the Sage Acquisition.
Current wording
We have financed our operations primarily with cash generated from product sales, supplemented by revenues from royalty and licensing arrangements, as well as proceeds from the sale of equity and debt securities. Continued cash generation is highly dependent on the success of our commercial products, as well as the success of our product candidates if approved by the FDA. While we expect continued profitability in future years, we anticipate there may be significant variability from year to year in the level of our profits particularly due to continued market and payor pressures for our commercial products; the unfavorable impact of the loss of patent exclusivity for Trokendi XR in January 2023 and Oxtellar XR in September 2024; the potential unfavorable impact of the forthcoming loss of exclusivity of XADAGO; funding for research and development of our product candidates; the additional funding for the launch of ONAPGO, which was approved by the FDA in February 2025 and launched in April 2025, the additional funding for the marketing of ZURZUVAE, and managing the Biogen Collaboration Agreement and obligations under the Biogen Collaboration Agreement which were acquired as part of the Sage Acquisition in July 2025.
Previous wording
Net cash provided by operating activities was $27.5 million compared to $127.5 million for the nine months ended September 30, 2025, and 2024, respectively. The decrease in cash flows provided by operating activities is primarily due to the decrease in net earnings as well as changes in working capital. The Company reported net loss of $34.4 million and net earnings of $58.5 million for the nine months ended September 30, 2025 and and 2024, respectively. The decline in earnings is principally due to $70.9 million acquisition-related costs incurred related to the to the Sage Acquisition in July 2025.
Current wording
Net cash provided by operating activities was $66.5 million compared to $30.6 million for the three months ended March 31, 2026, and 2025, respectively. The increase in cash flows provided by operating activities was primarily due to the decrease in net loss as well as changes in working capital. The Company reported net loss of $2.3 million and $11.8 million for the three months ended March 31, 2026 and 2025, respectively. The decrease in net loss was primarily due to an increase in total revenues due to the addition of revenues from ONAPGO and ZURZUVAE products, as well as licensing revenue from the achievement of a commercial milestone under our collaboration agreement with Shionogi. The Company launched ONAPGO in April 2025 and acquired ZURZUVAE as part of the Sage Therapeutics, Inc. acquisition in July 2025.
Previous wording
Net cash provided by investing activities was $55.4 million for the nine months ended September 30, 2025 compared to net cash used in investing activities of $177.2 million during the same period in 2024. The change was primarily due to the following:
Current wording
Net cash used in investing activities was $19.2 million for the three months ended March 31, 2026 compared to net cash provided by investing activities of $37.3 million during the same period in 2025. The change was primarily due to a decrease in the maturities of marketable securities partially offset by a decrease in the purchases of marketable securities.
Previous wording
Net cash provided by financing activities was $0.6 million for the nine months ended September 30, 2025 compared to $6.3 million provided by during the same period in 2024. The change was primarily due to the payment of USWM contingent consideration milestones, offset by higher proceeds from the issuances of common stock in 2025.
Current wording
Net cash provided by financing activities was $9.1 million for the three months ended March 31, 2026 compared to net cash used in financing activities of $21.4 million during the same period in 2025. The change was primarily due to an increase in proceeds from the issuance of common stock and the payment of USWM contingent consideration milestones in 2025.
Previous wording
Refer to "Part II, Item 7 — Management's Discussion and Analysis of Liquidity and Capital Resources" of our Annual Report on Form 10-K for the year ended December 31, 2024, and Note 17, Commitments and Contingencies, in the Notes to the Condensed Consolidated Financial Statements in Part I, Item 1, Unaudited Condensed Consolidated Financial Statements, of this Quarterly Report on Form 10-Q for the discussion of our contractual obligations.
Current wording
Refer to "Part II, Item 7 — Management's Discussion and Analysis of Liquidity and Capital Resources" of our Annual Report on Form 10-K for the year ended December 31, 2025, and Note 17, Commitments and Contingencies, in the Notes to the Condensed Consolidated Financial Statements in Part I, Item 1, Unaudited Condensed Consolidated Financial Statements, of this Quarterly Report on Form 10-Q for discussion of our other contractual obligations.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
•The 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.