SUPN — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-10-29

• •ONAPGOTM (apomorphine hydrochloride) injection is the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced PD. ONAPGO was approved by the FDA in February 2025. ONAPGO was launched in April 2025. In October 2026, the FDA recognized s…

• indicated for adults with PPD. ZURZUVAE became commercially available in the U.S. in December 2023 as a treatment option for women with PPD. The Company and our collaboration partner, Biogen, are jointly commercializing ZURZUVAE in the U.S. under the Biogen Collaboration Agreement. The Company and B…

• enhancing mTORC1 signaling. The intracellular mechanism and the lack of binding to cell surface receptors suggests the potential for a differentiated safety profile and is unlikely to have abuse potential.

• •ONAPGO net product sales were $17.1 million in the third quarter of 2026. Demand for the product continued to be healthy, with more than 400 enrollment forms submitted in the third quarter. In the third quarter 2026, prescriptions grew by 17% compared to the second quarter 2026. The U.S. Food and D…

• •GOCOVRI grew by approximately 4% in net sales and 4% in prescriptions in the third quarter of 2026, compared to the same period in 2025. Net sales reached an all-time high of $42.6 million in the third quarter of 2026.

Text removed vs the prior filing · source: 10-Q · 2026-08-03

• •ONAPGOTM (apomorphine hydrochloride) injection is the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced PD. ONAPGO was approved by the FDA in February 2025. ONAPGO was launched in April 2025.

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

• Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies in the second half of 2026.

• •ONAPGO net product sales were $13.5 million in the second quarter of 2026. Since the launch in April 2025, and through the end of July 2026, approximately 2,600 enrollment forms have been submitted by approximately 720 prescribers. The Company remains on-track to submit a regulatory filing to the F…

• •Net sales of GOCOVRI increased 2% to $37.6 million in the second quarter of 2026, compared to the same period in 2025. Total number of prescriptions grew by 9% in the second quarter of 2026 compared to the same period last year.

Text added vs the prior filing · source: 10-Q · 2026-10-29

• In October 2026, the Company terminated the Credit Line with UBS and we are no longer subject to interest rate risk associated with the Credit Line.

• As of September 30, 2026, our cash and cash equivalents consist primarily of cash held at banks and investments in highly liquid financial instruments with an original maturity of three months or less. Our marketable securities, which are reported at fair value, generally consist of investments in U…

Text removed vs the prior filing · source: 10-Q · 2026-08-03

• In the future, we may borrow funds under the Credit Line. Variable rate borrowing, which may occur under the Credit Line, exposes us to interest rate risk as increases in interest rates would increase our borrowing costs. Any borrowed funds pursuant to our Credit Line are subject to a collateral mai…

• portfolio of marketable securities, which is primarily comprised of corporate and U.S. government agency and municipal debt securities and may fluctuate in value. The fluctuations may be driven by, among other things, changes in interest rates, economic conditions, and other financial conditions as …

• Our cash and cash equivalents consist primarily of cash held at banks and investments in highly liquid financial instruments with an original maturity of three months or less. Our marketable securities, which are reported at fair value, generally consist of investments in U.S. Treasury bills and not…

Text added vs the prior filing · source: 10-Q · 2026-10-29

• The Company received a Paragraph IV Notice Letter from generic drug makers Aurobindo Pharma Limited and Aurobindo Pharma U.S.A., Inc. (collectively, Aurobindo) dated May 29, 2025, directed to six of its Qelbree® Orange Book patents. Supernus’s U.S. Patent Nos. 9,358,204; 9,603,853; 9,662,338; 11,324…

• The Company received a Paragraph IV Notice Letter from generic drug maker Creekwood Pharmaceuticals, LLC (Creekwood) dated June 4, 2025, directed to six of its Qelbree® Orange Book patents. Supernus’s U.S. Patent Nos. 9,358,204; 9,603,853; 9,662,338; 11,324,753; 11,458,143; and 12,121,523 generally …

• IV certification notice entitles Supernus to an automatic stay preventing the FDA from approving Creekwood’s ANDA until October 2, 2028. On September 19, 2025, Creekwood answered the Complaint and denied the substantive allegations of the Complaint, asserting affirmative defenses that include non-in…

• The Company received a Paragraph IV Notice Letter from generic drug maker Macleods Pharmaceuticals Ltd. (Macleods Ltd.) dated August 1, 2025, directed to six of its Qelbree® Orange Book patents. Supernus’s U.S. Patent Nos. 9,358,204; 9,603,853; 9,662,338; 11,324,753; 11,458,143; and 12,121,523 gener…

• The Company received a Paragraph IV Notice Letter from generic drug maker Zydus Lifesciences Global FZE ("Zydus FZE") dated March 25, 2026 directed to three of its Qelbree® Orange Book patents. Supernus's U.S. Patent Nos. 11 ,324,753; 11,458,143; and 12,121,523 generally cover viloxazine formulation…

Text removed vs the prior filing · source: 10-Q · 2026-08-03

• The Company received a Paragraph IV Notice Letter from generic drug makers Aurobindo Pharma Limited and Aurobindo Pharma U.S.A., Inc. (collectively, Aurobindo) dated May 29, 2025, directed to six of its Qelbree® Orange Book patents. Supernus’s U.S. Patent Nos. 9,358,204; 9,603,853; 9,662,338; 11,324…

• Company filed a lawsuit against Aurobindo alleging infringement of the Company’s Qelbree® Orange Book patents. The Complaint—filed in the U.S. District Court for the District of New Jersey—alleges, inter alia, that Aurobindo infringed the Company’s Qelbree® patents by submitting to the FDA an Abbrev…

• The Company received a Paragraph IV Notice Letter from generic drug maker Creekwood Pharmaceuticals, LLC (Creekwood) dated June 4, 2025, directed to six of its Qelbree® Orange Book patents. Supernus’s U.S. Patent Nos. 9,358,204; 9,603,853; 9,662,338; 11,324,753; 11,458,143; and 12,121,523 generally …

• lawsuits as In re Viloxazine, C.A. No. 25-cv-12183 (MEF)(MAH) (Consolidated), and administratively terminated the C.A. No. 25-cv-13201 (MEF)(MAH) (D.N.J.) action.

• The Company received a Paragraph IV Notice Letter from generic drug maker Macleods Pharmaceuticals Ltd. (Macleods Ltd.) dated August 1, 2025, directed to six of its Qelbree® Orange Book patents. Supernus’s U.S. Patent Nos. 9,358,204; 9,603,853; 9,662,338; 11,324,753; 11,458,143; and 12,121,523 gener…

Text added vs the prior filing · source: 10-Q · 2026-10-29

• The Merger is subject to conditions, some or all of which may not be satisfied, or completed on a timely basis, if at all. Failure to complete the Merger could have material adverse effects on our business.

• The completion of the Merger is subject to a number of conditions set forth in the Merger Agreement, which make the completion and timing of the Merger uncertain. The failure to satisfy all of the required conditions could delay the completion of the Merger for a significant period of time or preven…

• If the Merger is not completed, we may be materially adversely affected and, without realizing any of the benefits of having completed the Merger, will be subject to a number of risks, including the following:

• • we could owe a substantial termination fee to Indivior in specified circumstances;

• • time and resources committed by our management to matters relating to the Merger could otherwise have been devoted to pursuing other beneficial opportunities;

Text added vs the prior filing · source: 10-Q · 2026-10-29

• YesTerminatedAugust 12, 2026First Transaction Date through February 24, 2027—297,500

• YesTerminatedAugust 12, 2026First Transaction Date through June 15, 2027—5,000

• YesTerminatedAugust 12, 2026First Transaction Date through March 12, 2027—44,000