Supernus Pharmaceuticals(SUPN) - 2025 Q2 - Quarterly Report

PART I — FINANCIAL INFORMATION Item 1. Unaudited Condensed Consolidated Financial Statements Presents unaudited condensed consolidated financial statements for Q2 and H1 2025, detailing financial position, performance, and cash flows with explanatory notes Condensed Consolidated Balance Sheets Presents the company's financial position, detailing assets, liabilities, and equity as of June 30, 2025, and December 31, 2024 Condensed Consolidated Balance Sheets (in thousands) | Metric | June 30, 2025 (unaudited) | December 31, 2024 | | :-------------------------------- | :------------------------ | :------------------ | | Cash and cash equivalents | $144,711 | $69,331 | | Marketable securities | $377,885 | $384,281 | | Total current assets | $738,866 | $686,070 | | Total assets | $1,382,405 | $1,368,073 | | Total current liabilities | $286,360 | $292,397 | | Total liabilities | $318,505 | $332,340 | | Total stockholders' equity | $1,063,900 | $1,035,733 | - Cash and cash equivalents increased by $75.38 million (108.7%) from December 31, 2024, to June 30, 2025[8] - Total assets increased by $14.33 million (1.05%) from December 31, 2024, to June 30, 2025[8] - Total stockholders' equity increased by $28.167 million (2.72%) from December 31, 2024, to June 30, 2025[8] Condensed Consolidated Statements of Earnings Details the company's financial performance, including revenues, expenses, and net earnings for the three and six months ended June 30, 2025 Condensed Consolidated Statements of Earnings (in thousands, except per share data) | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net product sales | $157,995 | $162,538 | $299,983 | $300,999 | | Total revenues | $165,453 | $168,325 | $315,277 | $311,969 | | Total costs and expenses | $153,312 | $145,756 | $313,392 | $292,553 | | Operating earnings | $12,141 | $22,569 | $1,885 | $19,416 | | Net earnings | $22,499 | $19,916 | $10,672 | $20,040 | | Basic EPS | $0.40 | $0.36 | $0.19 | $0.37 | | Diluted EPS | $0.40 | $0.36 | $0.19 | $0.36 | - Net product sales decreased by 3% for the three months ended June 30, 2025, compared to the same period in 2024, and decreased by less than 1% for the six months ended June 30, 2025[12] - Total revenues decreased by 2% for the three months ended June 30, 2025, but increased by 1% for the six months ended June 30, 2025, compared to the respective prior year periods[12] - Net earnings increased by 13% for the three months ended June 30, 2025, but decreased by 47% for the six months ended June 30, 2025, compared to the respective prior year periods[12] Condensed Consolidated Statements of Comprehensive Earnings Presents the company's comprehensive earnings, including net earnings and other comprehensive income (loss), for Q2 and H1 2025 Condensed Consolidated Statements of Comprehensive Earnings (in thousands) | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net earnings | $22,499 | $19,916 | $10,672 | $20,040 | | Other comprehensive gain (loss) | $(41) | $162 | $(11) | $221 | | Comprehensive earnings | $22,458 | $20,078 | $10,661 | $20,261 | - Comprehensive earnings increased by 11.9% for the three months ended June 30, 2025, but decreased by 47.4% for the six months ended June 30, 2025, compared to the respective prior year periods[16] Condensed Consolidated Statements of Changes in Stockholders' Equity Outlines changes in stockholders' equity, including common stock, additional paid-in capital, and retained earnings, for the six months ended June 30, 2025 Changes in Stockholders' Equity (Six Months Ended June 30, 2025, in thousands) | Metric | Balance, Dec 31, 2024 | Share-based Compensation | Issuance of Common Stock | Net Earnings | Unrealized Loss | Balance, June 30, 2025 | | :------------------------ | :-------------------- | :----------------------- | :----------------------- | :----------- | :-------------- | :--------------------- | | Common Stock (Shares) | 55,743,095 | — | 376,265 | — | — | 56,119,360 | | Common Stock (Amount) | $56 | — | — | — | — | $56 | | Additional Paid-in Capital | $479,440 | $15,575 | $1,931 | — | — | $496,946 | | Accumulated Other Comprehensive Loss | $(189) | — | — | — | $(11) | $(200) | | Retained Earnings | $556,426 | — | — | $10,672 | — | $567,098 | | Total Stockholders' Equity | $1,035,733 | $15,575 | $1,931 | $10,672 | $(11) | $1,063,900 | - Total stockholders' equity increased by $28.167 million from December 31, 2024, to June 30, 2025, primarily driven by net earnings and share-based compensation[19] Condensed Consolidated Statements of Cash Flows Summarizes the company's cash inflows and outflows from operating, investing, and financing activities for the six months ended June 30, 2025 Condensed Consolidated Statements of Cash Flows (Six Months Ended June 30, in thousands) | Cash Flow Activity | 2025 | 2024 | | :----------------- | :---------- | :---------- | | Operating activities | $89,134 | $74,025 | | Investing activities | $6,710 | $(100,218) | | Financing activities | $(20,464) | $3,228 | | Net change in cash and cash equivalents | $75,380 | $(22,965) | | Cash and cash equivalents at end of period | $144,711 | $52,089 | - Net cash provided by operating activities increased by $15.109 million (20.4%) for the six months ended June 30, 2025, compared to the same period in 2024[25] - Net cash from investing activities shifted from a $100.218 million outflow in 2024 to a $6.710 million inflow in 2025, primarily due to lower purchases and higher maturities of marketable securities[25] - Net cash from financing activities shifted from a $3.228 million inflow in 2024 to a $20.464 million outflow in 2025, mainly due to contingent consideration payments for ONAPGO[25] Notes to Condensed Consolidated Financial Statements Provides detailed explanations of significant accounting policies, revenue disaggregation, investments, and other key financial statement items 1. Business Organization Describes Supernus Pharmaceuticals, Inc.'s core business, commercial products, and recent strategic acquisitions - Supernus Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing and commercializing products for central nervous system (CNS) diseases[30] - The company markets eight commercial products: Qelbree, GOCOVRI, Oxtellar XR, Trokendi XR, APOKYN, XADAGO, MYOBLOC, and ONAPGO[31] - ONAPGO (apomorphine hydrochloride) injection was FDA approved in February 2025 and launched in April 2025 for advanced Parkinson's Disease motor fluctuations[31] - On June 13, 2025, Supernus entered into an agreement to acquire Sage Therapeutics, Inc., a commercial-stage pharmaceutical company with ZURZUVAE for postpartum depression, with the acquisition closing on July 31, 2025[31][32] 2. Summary of Significant Accounting Policies Outlines the key accounting principles and policies used in preparing the unaudited condensed consolidated financial statements - The unaudited condensed consolidated financial statements are prepared in accordance with SEC requirements for interim financial information and U.S. GAAP[32] - The Company operates in one operating segment, primarily located in the U.S.[34][82] - Advertising expense was $25.3 million and $51.4 million for the three and six months ended June 30, 2025, respectively, recorded as Selling, general and administrative expenses[42] - The Company adopted ASU 2023-07 on January 1, 2024, and plans to adopt ASU 2023-09 for fiscal year 2025 and ASU 2024-03 for fiscal year 2027[45][46][47] 3. Disaggregated Revenues Provides a detailed breakdown of net product sales by individual product and other revenue streams for the reporting periods Net Product Sales by Product (in thousands) | Product | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :------------ | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Qelbree | $77,547 | $59,395 | $142,292 | $104,499 | | GOCOVRI | $36,660 | $31,703 | $67,349 | $58,265 | | APOKYN | $12,820 | $17,295 | $27,796 | $33,944 | | Trokendi XR | $11,193 | $17,086 | $23,994 | $33,075 | | Oxtellar XR | $11,637 | $29,516 | $21,835 | $56,459 | | ONAPGO | $1,604 | — | $1,604 | — | | Other | $6,534 | $7,543 | $15,113 | $14,757 | | Total Net Product Sales | $157,995 | $162,538 | $299,983 | $300,999 | | Royalty, licensing and other revenues | $7,458 | $5,787 | $15,294 | $10,970 | | Total Revenues | $165,453 | $168,325 | $315,277 | $311,969 | - Qelbree net product sales increased by 31% (3 months) and 36% (6 months) year-over-year[48] - Oxtellar XR net product sales decreased significantly by 61% for both three and six months periods year-over-year, primarily due to generic erosion[48] - ONAPGO generated $1.604 million in net product sales since its launch in April 2025[48] 4. Investments Details the company's marketable securities, including their amortized cost and fair value, as of June 30, 2025 Marketable Securities (in thousands) | Metric | June 30, 2025 (unaudited) | December 31, 2024 | | :---------------- | :------------------------ | :------------------ | | Amortized cost | $378,087 | $384,481 | | Total fair value | $377,885 | $384,281 | - All unrestricted available-for-sale marketable securities as of June 30, 2025, have contractual maturities of one year or less[49] 5. Fair Value of Financial Instruments Presents the fair value measurements of the company's financial assets and liabilities, categorized by valuation levels Fair Value Measurements as of June 30, 2025 (in thousands) | Asset/Liability | Total | Level 1 | Level 2 | Level 3 | | :-------------- | :--------- | :--------- | :--------- | :------ | | Cash | $53,557 | $53,557 | — | — | | Money market funds | $91,154 | $91,154 | — | — | | Corporate debt securities | $367,895 | — | $367,895 | — | | U.S government agency securities | $9,990 | — | $9,990 | — | | Marketable securities - restricted (SERP) | $660 | $24 | $636 | — | | Total assets at fair value | $523,256 | $144,735 | $378,521 | — | | Contingent consideration | — | — | — | — | | Total liabilities at fair value | — | — | — | — | Fair Value Measurements as of December 31, 2024 (in thousands) | Asset/Liability | Total | Level 1 | Level 2 | Level 3 | | :-------------- | :--------- | :--------- | :--------- | :------ | | Cash | $37,830 | $37,830 | — | — | | Money market funds | $31,501 | $31,501 | — | — | | Corporate debt securities | $355,201 | — | $355,201 | — | | U.S. government agency debt securities | $29,080 | — | $29,080 | — | | Marketable securities - restricted (SERP) | $635 | $21 | $614 | — | | Total assets at fair value | $454,247 | $69,352 | $384,895 | — | | Contingent consideration | $47,340 | — | — | $47,340 | | Total liabilities at fair value | $47,340 | — | — | $47,340 | - Contingent consideration liability decreased from $47.340 million at December 31, 2024, to $0 at June 30, 2025, due to milestone payments and reclassification[51] 6. Contingent Consideration Explains the company's contingent consideration liabilities related to acquisitions, including fair value changes and milestone payments - Contingent consideration liabilities are related to the USWM Acquisition (2020) and Adamas Acquisition (2021), measured at fair value using Monte Carlo simulation or income approach, classified as Level 3[54] - For the USWM Acquisition, the Company paid a $25 million milestone for FDA approval of ONAPGO in February 2025 and $2.3 million of a $30 million commercial launch milestone in Q2 2025, with $27.7 million held back and reclassified to Other current liabilities[55] - For the Adamas Acquisition, one CVR remains, payable upon GOCOVRI net sales exceeding $225 million in any consecutive 12-month period ending by December 31, 2025. The probability of achieving this milestone is remote as of June 30, 2025, with a fair value of $0[57][58][59] Change in Fair Value of Contingent Consideration (in thousands) | Metric | USWM Acquisition | Adamas Acquisition | Total | | :-------------------------------------- | :--------------- | :----------------- | :------- | | Balance at December 31, 2024 | $47,340 | — | $47,340 | | Change in fair value recognized in earnings | $7,660 | — | $7,660 | | Milestone payments | $(27,295) | — | $(27,295) | | Reclassification to Other Current Liabilities | $(27,705) | — | $(27,705) | | Balance at June 30, 2025 (unaudited) | — | — | — | 7. Intangible Assets, Net Details the company's intangible assets, including acquired technology and product rights, amortization expense, and patent expiration information Intangible Assets, Net (in thousands) | Asset Category | June 30, 2025 Net | December 31, 2024 Net | | :------------------------------------------- | :---------------- | :-------------------- | | Acquired in-process research and development | — | $124,000 | | Acquired developed technology and product rights | $481,307 | $397,912 | | Capitalized patent defense costs | — | — | | Total intangible assets | $481,307 | $521,912 | - Amortization expense for intangible assets was $20.8 million and $40.6 million for the three and six months ended June 30, 2025, respectively[63] - Upon FDA approval in February 2025, ONAPGO was reclassified from an acquired in-process research and development asset to a definite-life intangible asset subject to 10-year amortization[64] - U.S. patents for Trokendi XR and Oxtellar XR expire no earlier than 2027, with generic entry for Trokendi XR in Jan 2023 and Oxtellar XR in Sep 2024. XADAGO generic entry is expected in Dec 2027 or sooner[65] 8. Debt Describes the company's uncommitted demand secured line of credit and its outstanding debt status as of June 30, 2025 - The Company has an uncommitted demand secured line of credit with UBS for up to $150 million, secured by certain assets including a Collateral Account[66][67] - As of June 30, 2025, and December 31, 2024, there was no outstanding debt under the Credit Line[70] 9. Share-Based Payments Details the company's share-based compensation expense and stock option activity for the three and six months ended June 30, 2025 Share-Based Compensation Expense (in thousands) | Expense Category | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Research and development | $1,479 | $1,231 | $2,891 | $2,596 | | Selling, general and administrative | $6,028 | $5,321 | $12,684 | $9,853 | | Total | $7,507 | $6,552 | $15,575 | $12,449 | - Total share-based compensation expense increased by 14.6% for the three months and 25.1% for the six months ended June 30, 2025, compared to the respective prior year periods[71] Stock Option Activity | Metric | Number of Options (June 30, 2025) | Weighted Average Exercise Price | | :-------------------------- | :-------------------------------- | :------------------------------ | | Outstanding, Dec 31, 2024 | 6,719,073 | $30.44 | | Granted | 1,081,220 | $33.82 | | Exercised | (175,748) | $23.01 | | Forfeited | (97,131) | $34.37 | | Outstanding, June 30, 2025 | 7,527,414 | $31.04 | 10. Earnings per Share Presents the basic and diluted earnings per share calculations for the three and six months ended June 30, 2025 Earnings per Share Calculation | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Net earnings (in thousands) | $22,499 | $19,916 | $10,672 | $20,040 | | Basic EPS | $0.40 | $0.36 | $0.19 | $0.37 | | Diluted EPS | $0.40 | $0.36 | $0.19 | $0.36 | - Basic and diluted EPS increased by $0.04 for the three months ended June 30, 2025, but decreased by $0.18 and $0.17 respectively for the six months ended June 30, 2025, compared to the prior year periods[75] 11. Income Tax Expense (Benefit) Details the company's income tax expense or benefit and effective tax rates for the three and six months ended June 30, 2025 Income Tax Expense (Benefit) (in thousands) | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Income tax expense (benefit) | $(5,830) | $6,386 | $166 | $6,505 | | Effective tax rate | (35.0)% | 24.3% | 1.5% | 24.5% | - The Company recorded an income tax benefit of $5.8 million for the three months ended June 30, 2025, compared to an expense of $6.4 million in the prior year, primarily due to decreased pre-tax book income and a state tax refund[77][78] - The effective tax rate for the three months ended June 30, 2025, was (35.0)%, significantly lower than 24.3% in the prior year, and for the six months, it was 1.5% compared to 24.5% in the prior year[76][78] - The One Big Beautiful Bill Act (OBBBA), signed into law after June 30, 2025, includes changes to U.S. federal tax law, and the Company is evaluating its impact on future financial statements[80] 12. Leases Presents the company's operating lease assets and liabilities, along with cash paid for operating leases, as of June 30, 2025 Operating Lease Assets and Liabilities (in thousands) | Metric | June 30, 2025 (unaudited) | December 31, 2024 | | :------------------------------ | :------------------------ | :------------------ | | Operating lease assets | $21,881 | $24,477 | | Operating lease liabilities, current portion | $7,391 | $6,889 | | Operating lease liabilities, long-term | $24,383 | $27,382 | | Total lease liabilities | $31,774 | $34,271 | - Cash paid for operating leases was $7.290 million for the six months ended June 30, 2025, a decrease from $8.138 million in the prior year[81] 13. Segment Reporting Confirms the company operates in one operating segment, primarily in the U.S., with performance assessed by the CODM based on net earnings - The Company operates in one operating segment, deriving revenue primarily from sales of commercial products in the U.S.[82] - The chief executive officer serves as the chief operating decision maker (CODM), assessing performance and allocating resources based on net earnings[83] Segment Revenue and Significant Expenses (in thousands) | Metric (in thousands) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Total revenues | $165,453 | $168,325 | $315,277 | $311,969 | | Cost of goods sold | $16,827 | $17,916 | $32,590 | $34,225 | | Selling | $44,398 | $39,094 | $87,012 | $78,108 | | Marketing | $20,732 | $19,710 | $41,396 | $40,263 | | General and administrative | $28,421 | $27,100 | $55,087 | $54,049 | | Total research and development expenses | $22,115 | $26,183 | $49,042 | $51,113 | | Net earnings | $22,499 | $19,916 | $10,672 | $20,040 | 14. Composition of Other Balance Sheet Items Provides detailed breakdowns of inventories, accounts payable, accrued liabilities, and product returns and rebates Inventories, Net (in thousands) | Category | June 30, 2025 (unaudited) | December 31, 2024 | | :-------------- | :------------------------ | :------------------ | | Raw materials | $8,419 | $11,127 | | Work in process | $15,650 | $26,725 | | Finished goods | $19,954 | $16,441 | | Total | $44,023 | $54,293 | Accounts Payable and Accrued Liabilities (in thousands) | Category | June 30, 2025 (unaudited) | December 31, 2024 | | :-------------------------------------- | :------------------------ | :------------------ | | Accounts payable | $8,215 | $4,587 | | Accrued compensation, benefits, & related accruals | $20,463 | $21,225 | | Accrued sales & marketing | $15,960 | $11,007 | | Accrued manufacturing expenses | $7,953 | $11,652 | | Accrued R&D expenses | $3,293 | $5,898 | | Operating lease liabilities, current portion | $7,391 | $6,889 | | Accrued royalties | $5,127 | $8,105 | | Other accrued expenses | $9,337 | $6,989 | | Total | $77,739 | $76,352 | Accrued Product Returns and Rebates (in thousands) | Category | June 30, 2025 (unaudited) | December 31, 2024 | | :-------------------- | :------------------------ | :------------------ | | Accrued product rebates | $134,892 | $115,330 | | Accrued product returns | $46,024 | $53,375 | | Total | $180,916 | $168,705 | 15. Commitments and Contingencies Outlines the company's product licenses, development agreements, legal proceedings, and other significant commitments and contingencies - The Company has product licenses requiring milestone payments and royalties on net product sales, including those acquired through the USWM Acquisition (APOKYN, ONAPGO, XADAGO, MYOBLOC)[88][89] - Under the Navitor Development Agreement for SPN-820, the Company agreed to conduct further development activities at its own cost and Navitor Inc. waived its right to receive a $100 million Initial Acquisition Fee. Supernus exercised its option to purchase all Navitor assets[93] - The Company was released from its obligations under the Corporate Integrity Agreement (CIA) in April 2025, which was assumed as part of the USWM Acquisition[97] - The NAMENDA XR/Namzaric Qui Tam Litigation, alleging FCA violations, was dismissed by the District Court, affirmed by the Ninth Circuit on January 29, 2025, and the plaintiff opted not to seek Supreme Court review[100] - The APOKYN Litigation, an antitrust lawsuit, is ongoing with fact depositions mostly completed, and a jury trial scheduled for January 5, 2026. Mediation in April 2025 did not result in settlement[101] 16. Subsequent Event Details the company's acquisition of Sage Therapeutics, Inc., including the purchase price, contingent value rights, and closing date - On June 13, 2025, the Company entered into a Merger Agreement to acquire Sage Therapeutics, Inc. for approximately $561 million in cash plus contingent value rights (CVRs) up to $234 million[104] - The CVRs for the Sage acquisition are tied to ZURZUVAE annual net sales milestones in the U.S. ($250 million by end of 2027, $300 million by end of 2028, $375 million by end of 2030) and first commercial sale in Japan for MDD by June 30, 2026[105] - The acquisition of Sage Therapeutics, Inc. closed on July 31, 2025, making Sage a wholly-owned subsidiary[105] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management's discussion and analysis of the company's financial condition, liquidity, and results of operations for Q2 and H1 2025 Overview Provides a high-level summary of Supernus's business, recent acquisition of Sage Therapeutics, and its expected financial impacts - Supernus is a biopharmaceutical company focused on CNS diseases, with a diverse portfolio including treatments for ADHD, Parkinson's Disease, epilepsy, and migraine[111] - The acquisition of Sage Therapeutics, Inc. closed on July 31, 2025, bringing ZURZUVAE (for postpartum depression) into Supernus's portfolio[112][113][114] - The Sage acquisition is expected to increase net product sales, integration costs, SG&A expenses, and amortization of intangible assets, while reducing other income due to lower marketable securities[115] Commercial Products Highlights key commercial products, including Qelbree and ONAPGO, and their indications for various neurological conditions - Qelbree (viloxazine) extended-release capsules are indicated for ADHD in adults and pediatric patients 6 years and older, with an expanded label update in January 2025[118] - ONAPGO (apomorphine hydrochloride) injection, the first subcutaneous apomorphine infusion device for advanced PD motor fluctuations, was approved by the FDA in February 2025 and launched in April 2025[118] - GOCOVRI, Oxtellar XR, APOKYN, Trokendi XR, XADAGO, and MYOBLOC are other key commercial products addressing various neurological conditions[118] Research and Development Provides updates on the company's R&D pipeline, including SPN-817 for epilepsy, SPN-820 for depression, and SPN-443 for ADHD/CNS - SPN-817 (huperzine A) is a novel anticonvulsant in clinical development for epilepsy, with Orphan Drug Designation for several indications[120] - SPN-820 (NV-5138) is a first-in-class small molecule for depression; a Phase 2b study in TRD did not show statistical significance, but a follow-on Phase 2b trial for MDD is planned to start by end of 2025[121][122][127] - SPN-443, a novel stimulant for ADHD/CNS, completed a Phase 1 pharmacokinetic study in healthy adults, showing adequate bioavailability and good tolerability. A lead indication is expected by end of 2025[123][128] Commercial Highlights Showcases key commercial achievements, including prescription growth for Qelbree and the successful launch of ONAPGO - Qelbree prescriptions increased by 23% to 225,254 for Q2 2025, with approximately 36,000 prescribers, also up 23% year-over-year[124] - ONAPGO, launched in April 2025, is exceeding expectations with over 750 enrollment forms submitted by more than 300 prescribers by the end of Q2 2025[125] Product Pipeline Update Provides the latest updates on clinical trials for SPN-817, SPN-820, and SPN-443, including study progress and future plans - The Phase 2b study for SPN-817 in adult patients with treatment-resistant focal seizures is ongoing, targeting approximately 258 patients[126] - A new Phase 2b trial for SPN-820 in adults with major depressive disorder (MDD) is planned to start by the end of 2025, examining intermittent dosing as an adjunctive treatment[127] - SPN-443 completed a Phase 1 pharmacokinetic study, and the Company expects to disclose a lead indication for this product candidate by the end of 2025[128] Critical Accounting Policies and the Use of Estimates Confirms no significant changes to the company's critical accounting policies since the last Annual Report on Form 10-K - There were no significant changes to the Company's critical accounting policies as disclosed in its Annual Report on Form 10-K for the year ended December 31, 2024[129] Results of Operations Analyzes the company's financial performance, including detailed breakdowns of revenues, expenses, and their contributing factors Revenues Examines the company's net product sales and other revenue streams, highlighting changes and underlying drivers for the periods Revenue Performance (in thousands) | Revenue Category | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change Amount | Change Percent | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change Amount | Change Percent | | :--------------- | :--------------------------- | :--------------------------- | :------------ | :------------- | :--------------------------- | :--------------------------- | :------------ | :------------- | | Net product sales | $157,995 | $162,538 | $(4,543) | (3)% | $299,983 | $300,999 | $(1,016) | —% | | Royalty, licensing and other revenues | $7,458 | $5,787 | $1,671 | 29% | $15,294 | $10,970 | $4,324 | 39% | | Total revenues | $165,453 | $168,325 | $(2,872) | (2)% | $315,277 | $311,969 | $3,308 | 1% | - The decrease in net product sales was primarily due to lower volume of APOKYN and generic erosion for Oxtellar XR and Trokendi XR, partially offset by increases in Qelbree, GOCOVRI, and the launch of ONAPGO[131] - Royalty, licensing and other revenues increased due to a milestone achievement for Qelbree and higher royalty revenues from Oxtellar XR[140] Sales Deductions and Related Accruals Details changes in accrued product returns and rebates, explaining the factors influencing their balances for the reporting periods Accrued Product Returns and Rebates Activity (in thousands) | Metric | Product Returns (Dec 31, 2024) | Product Rebates (Dec 31, 2024) | Sales Discounts (Dec 31, 2024) | Total (Dec 31, 2024) | | :-------------------------- | :----------------------------- | :----------------------------- | :----------------------------- | :------------------- | | Balance at December 31, 2024 | $53,375 | $115,330 | $12,347 | $181,052 | | Total provision | $(5,192) | $207,489 | $34,074 | $236,371 | | Less: Actual payments/credits | $(2,159) | $(187,927) | $(33,656) | $(223,742) | | Balance at June 30, 2025 | $46,024 | $134,892 | $12,765 | $193,681 | - Accrued product returns decreased to $46.0 million as of June 30, 2025, from $58.5 million as of June 30, 2024, primarily due to a $12.5 million reduction in estimated provision for prior year Qelbree returns[136] - Accrued product rebates increased to $134.9 million as of June 30, 2025, from $116.6 million as of June 30, 2024, mainly due to timing of payments for government programs[137] Cost of Goods Sold Analyzes the changes in cost of goods sold, attributing them to product sales mix, royalties, and generic erosion impacts Cost of Goods Sold (in thousands) | Period | 2025 | 2024 | Change Amount | Change Percent | | :-------------------------- | :---------- | :---------- | :------------ | :------------- | | Three Months Ended June 30 | $16,827 | $17,916 | $(1,089) | (6)% | | Six Months Ended June 30 | $32,590 | $34,225 | $(1,635) | (5)% | - The decrease in cost of goods sold was primarily due to lower APOKYN royalties and decreases in MYOBLOC and Oxtellar XR due to generic erosion, partially offset by increases in Qelbree sales and ONAPGO launch[141] Research and Development Expenses Examines the fluctuations in R&D expenses, driven by clinical program costs for SPN-820 and SPN-817, for the reporting periods Research and Development Expenses (in thousands) | Period | 2025 | 2024 | Change Amount | Change Percent | | :-------------------------- | :---------- | :---------- | :------------ | :------------- | | Three Months Ended June 30 | $22,115 | $26,183 | $(4,068) | (16)% | | Six Months Ended June 30 | $49,042 | $51,113 | $(2,071) | (4)% | - The decrease in R&D expenses was primarily due to decreased clinical program costs for SPN-820, partially offset by increased costs for SPN-817[142] Selling, General and Administrative Expenses Analyzes changes in SG&A expenses, including selling, marketing, and general and administrative costs, for the reporting periods Selling, General and Administrative Expenses (in thousands) | Expense Category | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change Amount | Change Percent | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change Amount | Change Percent | | :-------------------------- | :--------------------------- | :--------------------------- | :------------ | :------------- | :--------------------------- | :--------------------------- | :------------ | :------------- | | Selling and marketing | $65,130 | $58,804 | $6,326 | 11% | $128,408 | $118,371 | $10,037 | 8% | | General and administrative | $28,421 | $27,100 | $1,321 | 5% | $55,087 | $54,049 | $1,038 | 2% | | Total SG&A | $93,551 | $85,904 | $7,647 | 9% | $183,495 | $172,420 | $11,075 | 6% | - The increase in selling and marketing expenses was primarily due to higher professional and consulting expenses and employee-related expenses, as well as timing of product sample shipments for the six-month period[143][144] Amortization of Intangible Assets Details the amortization expense for intangible assets, influenced by ONAPGO launch and full amortization of other assets Amortization of Intangible Assets (in thousands) | Period | 2025 | 2024 | Change Amount | Change Percent | | :-------------------------- | :---------- | :---------- | :------------ | :------------- | | Three Months Ended June 30 | $20,819 | $20,108 | $711 | 4% | | Six Months Ended June 30 | $40,605 | $40,245 | $360 | 1% | - The increase was primarily due to ONAPGO amortization expense in 2025, offset by the full amortization of Oxtellar XR and Namzaric intangible assets in 2024[146] Contingent Consideration Loss (Gain) Explains the change in contingent consideration from a gain to a loss, driven by ONAPGO milestone payments Contingent Consideration Loss (Gain) (in thousands) | Period | 2025 | 2024 | Change Amount | | :-------------------------- | :---------- | :---------- | :------------ | | Three Months Ended June 30 | — | $(4,355) | $4,355 | | Six Months Ended June 30 | $7,660 | $(5,450) | $13,110 | - The change to a loss for the six months ended June 30, 2025, was driven by the accretion of USWM contingent consideration liabilities to full milestone payment amounts following ONAPGO's FDA approval[148] Other Income (Expense) Analyzes the increase in other income, primarily due to higher interest income from marketable securities in 2025 Other Income (Expense) (in thousands) | Period | 2025 | 2024 | Change Amount | Change Percent | | :-------------------------- | :---------- | :---------- | :------------ | :------------- | | Three Months Ended June 30 | $4,528 | $3,733 | $795 | 21% | | Six Months Ended June 30 | $8,953 | $7,129 | $1,824 | 26% | - The increase in other income was due to higher interest income on marketable securities, driven by an overall higher investment balance in 2025[150] Income Tax Expense Details the income tax expense or benefit, highlighting the impact of decreased pre-tax income and a state tax refund Income Tax Expense (Benefit) (in thousands) | Period | 2025 | 2024 | Change Amount | | :-------------------------- | :---------- | :---------- | :------------ | | Three Months Ended June 30 | $(5,830) | $6,386 | $(12,216) | | Six Months Ended June 30 | $166 | $6,505 | $(6,339) | - The Company recorded an income tax benefit for the three months and a significantly lower expense for the six months ended June 30, 2025, primarily due to decreased pre-tax book income and a state tax refund[151][152] Financial Condition, Liquidity and Capital Resources Assesses the company's financial health, liquidity position, and capital resources, including cash, investments, and future requirements Cash and Cash Equivalents and Marketable Securities Details the company's cash, cash equivalents, and marketable securities, and their sufficiency for future cash requirements Cash and Marketable Securities (in thousands) | Metric | June 30, 2025 | December 31, 2024 | Change Amount | Change Percent | | :------------------------ | :------------ | :---------------- | :------------ | :------------- | | Cash and cash equivalents | $144,711 | $69,331 | $75,380 | 109% | | Marketable securities | $377,885 | $384,281 | $(6,396) | (2)% | | Total | $522,596 | $453,612 | $68,984 | 15% | - The Company believes its $522.6 million in cash, cash equivalents, and unrestricted marketable securities, along with cash from operations, will be sufficient to meet cash requirements for the next 12 months and beyond[154] - Future cash generation is dependent on commercial product success, R&D funding, and the impact of generic erosion and the Sage acquisition, which is expected to decrease marketable securities as funds were used for the acquisition[155] Cash Flows Summarizes cash flow changes from operating, investing, and financing activities, highlighting key drivers for the periods Cash Flow Summary (Six Months Ended June 30, in thousands) | Cash Flow Activity | 2025 | 2024 | Change Amount | | :----------------- | :---------- | :---------- | :------------ | | Operating activities | $89,134 | $74,025 | $15,109 | | Investing activities | $6,710 | $(100,218) | $106,928 | | Financing activities | $(20,464) | $3,228 | $(23,692) | | Net change in cash and cash equivalents | $75,380 | $(22,965) | $98,345 | - Operating cash flow increased due to working capital changes, while investing cash flow improved significantly due to lower marketable securities purchases and higher maturities[158][159] - Financing cash flow shifted to an outflow primarily due to contingent consideration payments for ONAPGO milestones[160] Material Cash Requirements Discusses the impact of the Sage Therapeutics acquisition on the company's investment balance and future cash requirements - The acquisition of Sage Therapeutics, Inc. in Q3 2025 is expected to decrease the Company's investment balance as marketable securities were sold to fund the acquisition[162] Recently Issued Accounting Pronouncements Refers to Note 2 for a discussion of new accounting pronouncements and their potential impact on the financial statements - For a discussion of new accounting pronouncements, refer to Note 2, Summary of Significant Accounting Policies, in the Notes to the Condensed Consolidated Financial Statements[163] Item 3. Quantitative and Qualitative Disclosures about Market Risk Discusses the company's exposure to market risks, including interest rate, liquidity, and foreign currency risks, and its investment strategy - As of June 30, 2025, the Company held $522.6 million in cash, cash equivalents, and marketable securities, primarily in investment-grade securities with maturities of four years or less[164][166] - The uncommitted demand secured Credit Line exposes the Company to interest rate risk and collateral maintenance requirements, with the lender having the right to terminate the line or demand payment at any time[165] - The Company does not hedge foreign currency exchange rate risk and does not believe inflation had a significant impact on results for the six months ended June 30, 2025, but acknowledges future variability in labor and vendor costs[168][169] Item 4. Controls and Procedures Confirms the effectiveness of the company's disclosure controls and procedures and reports no material changes in internal control over financial reporting - The Company's disclosure controls and procedures were evaluated and concluded to be effective as of June 30, 2025[170] - No material changes occurred in the Company's internal control over financial reporting during the quarter ended June 30, 2025[172] PART II — OTHER INFORMATION Item 1. Legal Proceedings Details various legal proceedings, including patent infringement lawsuits, antitrust litigation, and insurance coverage disputes Qelbree® Litigation Outlines multiple patent infringement lawsuits filed against generic drug manufacturers for Qelbree, triggering an FDA stay - Supernus filed multiple lawsuits against generic drug makers (Appco, Somerset, Apotex, Aurobindo, Zydus, Creekwood, MSN, Zenara) in June and July 2025 for infringing Qelbree Orange Book patents[174][175][176][178][179][180][181][183][184][185][186] - These lawsuits trigger an automatic stay, preventing the FDA from approving the generic Abbreviated New Drug Applications (ANDAs) until October 2, 2028[174][175][176][178][179][180][182][183][184][185][187] - The Qelbree patents generally cover viloxazine formulations and methods of use, with expiration dates ranging from September 4, 2029, to April 2, 2035[174][175][176][178][179][180][181][183][184][185][187] Trokendi XR® Litigation Details the settlement of a lawsuit against Ajanta Pharma and the ongoing appeal in the patent infringement case against Torrent Pharmaceuticals - The lawsuit against Ajanta Pharma Limited regarding Trokendi XR patents was settled, and a stipulation of dismissal without prejudice was entered on April 4, 2023[188] - In the lawsuit against Torrent Pharmaceuticals Ltd., the District Court ruled in Supernus's favor on January 30, 2024, finding patent claims valid and infringed, and issued an injunction[190] - Torrent filed an appeal of the Final Judgment with the U.S. Court of Appeals for the Federal Circuit on March 4, 2024, and the case is pending oral argument[191] APOKYN® Litigation Covers the ongoing antitrust lawsuit concerning APOKYN, including denied motions to dismiss, completed depositions, and a scheduled jury trial - Sage Chemical, Inc. and TruPharma, LLC filed an antitrust lawsuit against Supernus and others in October 2022 concerning APOKYN[192] - Motions to dismiss by defendants were largely denied, and fact depositions are mostly completed, with a jury trial scheduled to begin on January 5, 2026[192] - A mediation held in April 2025 did not result in a settlement for any of the parties[192] Insurance Coverage Litigation Details consolidated declaratory judgment actions against insurance companies to recover benefits related to an underlying legal action - Supernus is involved in consolidated declaratory judgment actions against various insurance companies (Federal Insurance Company, RSUI Indemnity Company, StarStone Specialty Insurance Company, Old Republic Insurance Company) to recover insurance benefits related to an underlying action[193][195] - These cases are in early stages, with discovery not yet commenced in the consolidated action, and a proposed scheduling order for discovery on coverage issues due by August 22, 2025[193][194][195] US WorldMeds Partners, LLC v. Supernus Pharmaceuticals, Inc. Reports a complaint filed by US WorldMeds Partners, LLC seeking payment of a withheld milestone payment from Supernus - US WorldMeds Partners, LLC filed a complaint in Delaware Superior Court seeking payment of $27.7 million withheld by Supernus from a $30.0 million milestone payment, pursuant to a set-off provision[196] Adamas Litigation Details the dismissal and subsequent affirmation of a qui tam complaint alleging false claims acts violations related to NAMENDA XR and Namzaric - A qui tam complaint alleging federal and state false claims acts violations related to NAMENDA XR and Namzaric patents was dismissed by the District Court on March 20, 2023[200][202] - The Ninth Circuit affirmed the District Court's dismissal on January 29, 2025, and the plaintiff's petition for rehearing was denied. The plaintiff opted not to seek review from the U.S. Supreme Court[202] Item 1A. Risk Factors Highlights new or changed risk factors, including potential cost increases from tariffs and impacts from U.S. pharmaceutical pricing policies - Tariffs on imported products and services, including pharmaceutical products, may increase the Company's costs or its vendors' production costs, potentially impacting financial results[206] - Recent U.S. Executive Orders aiming to lower pharmaceutical product prices could impact the Company's financial results if they lead to price reductions for its commercial products[207] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds States that no unregistered sales of equity securities or use of proceeds were reported for the period - No unregistered sales of equity securities were reported[208] Item 3. Defaults Upon Senior Securities Confirms that there were no defaults upon senior securities reported during the current reporting period - No defaults upon senior securities were reported[209] Item 4. Mine Safety Disclosures States that there are no mine safety disclosures to report for the current period - No mine safety disclosures were reported[210] Item 5. Other Information Provides details on insider trading arrangements, specifically a Rule 10b5-1 plan adopted by Bethany Sensenig in Q2 2025 Insider Trading Arrangements Adopted (Q2 2025) | Name and Title of Director or Officer | Rule 10b5-1 Trading Arrangement | Trading Arrangement Adopted or Terminated | Date of Adoption or Termination | Duration of Trading Arrangement | Aggregate Number of Securities to be Sold | | :------------------------------------ | :------------------------------ | :---------------------------------------- | :------------------------------ | :------------------------------ | :---------------------------------------- | | Bethany Sensenig | Yes | Adopted | May 15, 2025 | February 25, 2026 | 9,844 | - The trading arrangement covers the exercise and sale of stock options, with sales limited to cover exercise costs and taxes[211] Item 6. Exhibits Lists all exhibits filed or furnished with the Quarterly Report on Form 10-Q, including certifications and merger agreements - Exhibits include certifications from the CEO and CFO (31.1, 31.2, 32.1, 32.2), the Agreement and Plan of Merger for Sage Therapeutics (2.1†), and financial information in Inline XBRL format (101, 104)[213] SIGNATURES Contains the duly authorized signatures of the company's President, CEO, and Senior Vice-President, CFO, affirming the report filing - The report is signed by Jack A. Khattar, President and Chief Executive Officer, and Timothy C. Dec, Senior Vice-President and Chief Financial Officer, on August 5, 2025[217]