Topiramate

AAN, AES and SMFM Collaborate to Develop Updated Guidance MINNEAPOLIS, May 15, 2024 /PRNewswire/ -- A new guideline has been issued to help neurologists and other clinicians determine the best antiseizure medications for people with epilepsy who may become pregnant. The guideline is published in the May 15, 2024, online issue of Neurology®, the medical journal of the American Academy of Neurology (AAN), and was developed through a collaboration between the AAN, the American Epilepsy Society (AES) and the Society for Maternal-Fetal Medicine (SMFM). It was endorsed by the Child Neurology Society. The guideline partially updates two 2009 AAN and AES guidelines on the management of epilepsy during pregnancy, specifically regarding malformations at birth and the development of children born to people with epilepsy. "Most children born to people with epilepsy are healthy, but there is a small risk of pregnancy-related problems, partly due to seizures and partly due to the effects of antiseizure medications," said author Alison M. Pack, MD, MPH, of Columbia University in New York City, a Fellow of the American Academy of Neurology and a member of the American Epilepsy Society. "This guideline provides recommendations regarding the effects of antiseizure medications and folic acid supplementation on malformations at birth and the development of children during pregnancy so that doctors and people with epilepsy can determine which treatments may be best for them." The guideline recommendations are based on a review of all available evidence on the topic. Risks can include major congenital malformations, or birth defects, fetal growth issues and neurodevelopmental effects such as autism or lower IQ scores. The guideline states when treating people with epilepsy who may become pregnant, doctors should recommend medications and doses that optimize both seizure control and fetal development at the earliest possible opportunity before pregnancy. During pregnancy, it recommends minimizing the occurrence of tonic-clonic seizures, seizures with full body spasms, to minimize risks to the parent and fetus. It also says stopping medications during pregnancy may increase the frequency of seizures, which may harm the parent and fetus. For medications, the guideline recommends using lamotrigine, levetiracetam or oxcarbazepine when appropriate to minimize risk of major birth defects. It recommends avoiding valproic acid, phenobarbital and topiramate when possible. To reduce the risk of poor neurodevelopmental outcomes, including autism spectrum disorder and lower IQ scores, the guideline recommends clinicians avoid prescribing valproic acid, when possible, to people with epilepsy who may become pregnant. The guideline recommends that people with epilepsy who may become pregnant take at least 0.4 milligrams of folic acid daily before and during pregnancy to decrease the risk of neural tube defects and possibly improve neurodevelopmental outcomes. However, it notes further studies are needed to clarify the optimal dose and timing of folic acid supplementation. "People with epilepsy who may become pregnant want to ensure the best health of their child while still managing and minimizing their seizures," said Pack. "This is why it is important to discuss plans for pregnancy with your doctor before becoming pregnant and notify your doctor as soon as possible if you discover you are pregnant. Don't stop or change your medications. Talk with your doctor about any concerns you have about your medications." There are some medications that did not have enough evidence to be evaluated and need more research about their associated risk. The guideline was funded by the American Academy of Neurology. About the American Academy of Neurology The American Academy of Neurology is the world's largest association of neurologists and neuroscience professionals, with over 40,000 members. The AAN's mission is to enhance member career fulfillment and promote brain health for all. A neurologist is a doctor with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as Alzheimer's disease, stroke, concussion, epilepsy, Parkinson's disease, multiple sclerosis, headache and migraine. For more information about the American Academy of Neurology, visit AAN.com or find us on Facebook, Twitter, Instagram, LinkedIn and YouTube. About the American Epilepsy Society Founded in 1936, the American Epilepsy Society is a medical and scientific society whose members are dedicated to advancing research and education for preventing, treating and curing epilepsy. AES is an inclusive global forum where professionals from academia, private practice, not-for-profit, government and industry can learn, share and grow to eradicate epilepsy and its consequences. About the Society for Maternal-Fetal Medicine (SMFM) The Society for Maternal-Fetal Medicine (SMFM), founded in 1977, is the medical professional society for maternal-fetal medicine subspecialists, who are obstetricians with additional training in high-risk pregnancies. SMFM represents more than 7,000 members who care for high-risk pregnant people and provides education, promotes research, and engages in advocacy to advance optimal and equitable perinatal outcomes for all people who desire and experience pregnancy. For more information, visit SMFM.org. SOURCE American Academy of Neurology

Net sales of Qelbree® increased 75% to $45.1 million compared to first quarter 2023.Total revenues were $143.6 million. Total revenues excluding Trokendi XR® and Oxtellar XR® net product sales (non-GAAP)(1) increased 12% to $100.7 million compared to first quarter 2023.Operating loss was $(3.2) million. Adjusted operating earnings (non-GAAP)(1) was $22.3 million.Reiterates full year 2024 financial guidance, including total revenue guidance of $580 million to $620 million, operating loss guidance of $(30) million to $0 million, and adjusted operating earnings (non-GAAP) guidance of $80 million to $110 million. ROCKVILLE, Md., May 08, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced financial results for the first quarter of 2024 and associated Company developments. "We are pleased to announce another strong quarter for Qelbree, which delivered robust growth of 75% in net sales compared to the same quarter in the prior year," said Jack Khattar, President and CEO of Supernus. "We remain focused on driving the Company's long-term growth as we complete the transition from our legacy products to our growth products and as we progress our pipeline of novel product candidates." Business Highlights Qelbree Update Total IQVIA prescriptions were 176,503 for first quarter 2024, an increase of 31% compared to the prior year period.Patient enrollment is ongoing in the Phase IV open-label study to assess the efficacy of Qelbree over the course of 14 weeks of treatment in approximately 500 adults with attention deficit hyperactivity disorder (ADHD) and mood symptoms. The primary outcome measure is change from baseline in the Adult ADHD Investigator Symptom Rating Scale (AISRS). Product Pipeline Update SPN-830 (apomorphine infusion device) for treatment of Parkinson's disease (PD) In April 2024, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) in response to the Company’s New Drug Application (NDA) for SPN-830. The CRL indicates that the review cycle for the application is complete, but that the application is not ready for approval in its present form.The Company will announce the timing for its resubmission after further discussion with the FDA, which is expected to take place in May 2024. SPN-820 – Novel first-in-class molecule that increases mTORC1 mediated synaptic function for depression More than half the number of planned patients have been enrolled in the ongoing Phase IIb multi-center randomized double-blind placebo-controlled parallel design study of SPN-820 in adults with treatment-resistant depression. The study is examining efficacy and safety of SPN-820 over a course of five weeks of treatment in approximately 268 patients in up to 50 clinical sites. The primary outcome measure is the change from baseline to end of treatment period on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. Topline data from the Phase IIb trial is expected in the first half of 2025.The Company has initiated a Phase II open-label study in approximately 40 subjects with major depressive disorder (MDD). The primary objective of the study is to assess efficacy in MDD, as well as onset of efficacy. SPN-817 – Novel first-in-class highly selective AChE inhibitor for epilepsy The Company will hold a conference call on Thursday, May 23, 2024 to report on interim data from approximately 40 patients from the open-label Phase IIa clinical study of SPN-817 for treatment-resistant seizures (webcast details forthcoming). The study is examining the safety and tolerability of SPN-817 as adjunctive therapy in adult patients with treatment-resistant seizures, as well as assessing efficacy. Topline results for the full study are expected in the second half of 2024. SPN-443 – Novel stimulant for ADHD/CNS The Company plans to initiate a Phase I single dose study in healthy adults in 2024 following submission of an Investigational New Drug application. The primary objective of the study is to assess safety and tolerability. First Quarter 2024 Financial Results This section includes information on non-GAAP financial measures. See “Non-GAAP Financial Information” section for information on non-GAAP financial measures. In addition, a reconciliation of applicable GAAP to non-GAAP financial information is included at the end of this press release. Revenues The following table provides information regarding total revenues (dollars in millions): Three Months EndedMarch 31, 2024 2023 Change %Net product sales Qelbree$45.1 $25.8 75%Oxtellar XR 26.9 28.9 (7)%GOCOVRI® 26.5 26.0 2%APOKYN® 16.7 17.2 (3)%Trokendi XR 16.0 34.8 (54)%Other(2) 7.2 7.9 (9)%Total net product sales 138.4 140.6 (2)%Royalty and licensing revenues(3) 5.2 13.2 (61)%Total revenues$143.6 $153.8 (7)% Total revenues excluding Trokendi XR and Oxtellar XR net product sales (non-GAAP)(1)$100.7 $90.1 12% Total revenues were $143.6 million, compared to $153.8 million in the same period in 2023. Total net product sales were $138.4 million, compared to $140.6 million in the same period in 2023. The decrease was primarily due to the decline in net sales of Trokendi XR offset by an increase in net sales of Qelbree.Total revenues excluding Trokendi XR and Oxtellar XR net product sales (non-GAAP) increased 12% compared to the same period in 2023. Other Financial Highlights Operating loss was $(3.2) million compared to operating earnings of $5.2 million in the same period in 2023. The decrease was primarily due to lower royalty revenue.Adjusted operating earnings (non-GAAP) were $22.3 million compared to $30.5 million in the same period in 2023.Net earnings and diluted earnings per share were $0.1 million and $0.00, respectively, compared to $16.9 million and $0.29, respectively, in the same period in 2023.At March 31, 2024, cash, cash equivalents, and current and long-term marketable securities were approximately $309.4 million compared to $271.5 million as of December 31, 2023. This increase was primarily due to cash generated from operations. Full Year 2024 Financial Guidance For the full year 2024, the Company reiterates its full year 2024 financial guidance as set forth below (dollars in millions). Amount(as of February 27, 2024)Total revenues (includes approximately $125 - $135 million of Trokendi XR and Oxtellar XR)(4)(5)$580 - $620Combined R&D and SG&A expenses$430 - $460Operating loss(6)$(30) - $(0)Adjusted operating earnings (non-GAAP)(1)$80 - $110 Non-GAAP Financial Information This press release contains financial measures that present financial information which do not comply with United States generally accepted accounting principles (GAAP). The non-GAAP financial measures should be considered in addition to, not as a substitute for or in isolation from, or superior to measures prepared in accordance with GAAP. Non-GAAP adjusted operating earnings adjusts for non-cash share-based compensation expense, depreciation and amortization, intangible asset impairment charges and changes to fair value of contingent consideration, and for factors that are unusual, non-recurring or unpredictable, and excludes those costs, expenses, and other specified items presented in the reconciliation tables in this press release. In addition to non-GAAP adjusted operating earnings, we also present total revenues excluding net product sales of Trokendi XR (GAAP) and Oxtellar XR (GAAP), which is a non-GAAP measure and is calculated as total revenues (GAAP) less net product sales of Trokendi XR (GAAP) and Oxtellar XR (GAAP). Beginning in the year a product loses exclusivity due to generic entrants we generally do not expect net product sales of such products to constitute a significant part of our revenue in the future. We believe that the use of non-GAAP financial measures provides useful supplemental information to management, investors, analysts and others regarding the Company’s revenue and results of operations and assist management, investors, analysts, and others in understanding and evaluating our revenue growth and the performance of the business. There are limitations associated with the use of non-GAAP financial measures and therefore comparability may be limited. These limitations include: non-GAAP financial measures that may not be entirely comparable to similarly titled measures used by other companies; these may not reflect all items of income and expense, as applicable, that affect our operations; there may be potential differences among calculation methodologies; these may differ from the non-GAAP information used by other companies, including peer companies. We mitigate these limitations by reconciling the non-GAAP financial measure to the most comparable GAAP financial measure. Investors are encouraged to review the reconciliation. The Company’s 2024 financial guidance is also being provided on both a GAAP and a non-GAAP basis. End Notes (1) See the section titled “Non-GAAP Financial Information” for information about this non-GAAP financial measure. A reconciliation of each non-GAAP financial measure to the most directly comparable GAAP financial measure is included at the end of this press release.(2) Includes net product sales of MYOBLOC®, XADAGO® and Osmolex ER®.(3) Royalty and licensing revenues include royalties on generic Trokendi XR, other licensed products and intellectual property.(4) Includes net product sales and royalty and licensing revenue.(5) Reflects continued generic erosion of Trokendi XR and generic erosion of Oxtellar XR beginning in September 2024.(6) Includes amortization of intangible assets and contingent consideration expense (gain). Conference Call Details Supernus will host a conference call and webcast today, May 8, 2024, at 4:30 p.m. Eastern Time to discuss these results. A live webcast will be available in the Events & Presentations section of the Company’s Investor Relations website www.supernus.com/investors. Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time. Following the live call, a replay will be available on the Company's Investor Relations website www.supernus.com/investors. The webcast will be available on the Company’s website for 60 days following the live call. About Supernus Pharmaceuticals, Inc. Supernus Pharmaceuticals is 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 epilepsy, migraine, ADHD, hypomobility in Parkinson's disease (PD), cervical dystonia, chronic sialorrhea, dyskinesia in PD patients receiving levodopa-based therapy, and drug-induced extrapyramidal reactions in adult patients. We are developing a broad range of novel CNS product candidates including new potential treatments for hypomobility in PD, epilepsy, depression, and other CNS disorders. For more information, please visit www.supernus.com. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not convey historical information but relate to predicted or potential future events that are based upon management's current expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In addition to the factors mentioned in this press release, such risks and uncertainties include, but are not limited to, the Company’s ability to sustain and increase its profitability; the Company’s ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Company’s corporate strategy; the Company’s future financial performance and projected expenditures; the Company’s ability to increase the number of prescriptions written for each of its products and the products of its subsidiaries; the Company’s ability to increase its net revenue; the Company’s ability to commercialize its products and the products of its subsidiaries; the Company’s ability to enter into future collaborations with pharmaceutical companies and academic institutions or to obtain funding from government agencies; the Company’s product research and development activities, including the timing and progress of the Company’s clinical trials, and projected expenditures; the Company’s ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company’s product candidates; the Company’s ability to protect its intellectual property and the intellectual property of its subsidiaries and operate its business without infringing upon the intellectual property rights of others; the Company’s expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Company’s product candidates; the accuracy of the Company’s estimates of the size and characteristics of the markets that may be addressed by its product candidates; the Company’s ability to increase its manufacturing capabilities for its products and product candidates; the Company’s projected markets and growth in markets; the Company’s product formulations and patient needs and potential funding sources; the Company’s staffing needs; the Company’s ability to increase the number of prescriptions written for each of its products and the products of its subsidiaries; the Company’s ability to increase its net revenue from its products and the products of its subsidiaries; and other risk factors set forth from time to time in the Company’s filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. The Company undertakes no obligation to update the information in this press release to reflect events or circumstances after the date hereof or to reflect the occurrence of anticipated or unanticipated events. Supernus Pharmaceuticals, Inc.Condensed Consolidated Balance Sheets(in thousands, except share data) March 31, December 31, 2024 2023 (unaudited) Assets Current assets Cash and cash equivalents$63,401 $75,054 Marketable securities 234,335 179,820 Accounts receivable, net 147,734 144,155 Inventories, net 75,079 77,408 Prepaid expenses and other current assets 23,772 16,676 Total current assets 544,321 493,113 Long-term marketable securities 11,662 16,617 Property and equipment, net 12,969 13,530 Intangible assets, net 579,752 599,889 Goodwill 117,019 117,019 Other assets 38,367 37,505 Total assets$1,304,090 $1,277,673 Liabilities and stockholders’ equity Current liabilities Accounts payable and accrued liabilities$86,402 $79,569 Accrued product returns and rebates 167,226 154,274 Contingent consideration, current portion 51,379 52,070 Other current liabilities 9,547 4,283 Total current liabilities 314,554 290,196 Contingent consideration, long term 976 1,380 Operating lease liabilities, long term 32,994 33,196 Deferred income tax liabilities, net 19,501 24,963 Other liabilities 6,899 6,422 Total liabilities 374,924 356,157 Stockholders’ equity Common stock, $0.001 par value; 130,000,000 shares authorized; 54,965,316 and 54,723,356 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively 55 55 Additional paid-in capital 446,960 439,493 Accumulated other comprehensive (loss) earnings, net of tax (534) (593)Retained earnings 482,685 482,561 Total stockholders’ equity 929,166 921,516 Total liabilities and stockholders’ equity$1,304,090 $1,277,673 Supernus Pharmaceuticals, Inc.Condensed Consolidated Statements of Earnings(in thousands, except share and per share data) Three Months EndedMarch 31, 2024 2023 (unaudited)Revenues Net product sales$138,461 $140,575 Royalty and licensing revenues 5,183 13,189 Total revenues 143,644 153,764 Costs and expenses Cost of goods sold(a) 16,309 23,460 Research and development 24,930 21,212 Selling, general and administrative 86,516 85,597 Amortization of intangible assets 20,137 19,966 Contingent consideration gain (1,095) (1,647)Total costs and expenses 146,797 148,588 Operating earnings (loss) (3,153) 5,176 Other income (expense) Interest and other income, net 3,396 5,346 Interest expense — (1,505)Total other income (expense) 3,396 3,841 Earnings before income taxes 243 9,017 Income tax expense (benefit) 119 (7,931)Net earnings$124 $16,948 Earnings per share Basic$0.00 $0.31 Diluted$0.00 $0.29 Weighted average shares outstanding Basic 54,801,748 54,380,947 Diluted 55,626,663 62,454,204 (a) Excludes amortization of intangible assets. Supernus Pharmaceuticals, Inc.Reconciliations of GAAP to Non-GAAP Financial Information(Unaudited) Reconciliation of GAAP Total revenues to Non-GAAP Total revenues excluding Trokendi XR and Oxtellar XR net product sales An itemized reconciliation between total revenues on a GAAP basis and Total revenues excluding Trokendi XR and Oxtellar XR net product sales, a non-GAAP measure, is as follows (unaudited, dollars in millions): Three Months EndedMarch 31, 2024 2023 Change %Total revenues (GAAP)(1)$143.6 $153.8 (7)%Adjustments: Trokendi XR net product sales (16.0) (34.8) (54)%Oxtellar XR net product sales (26.9) (28.9) (7)%Total revenues excluding Trokendi XR and Oxtellar XR net product sales (non-GAAP)(1)$100.7 $90.1 12% (1) Includes net product sales and royalty and licensing revenues. Reconciliation of GAAP Operating earnings (loss) to Non-GAAP Adjusted Operating earnings An itemized reconciliation between operating earnings (loss) on a GAAP basis and adjusted operating earnings on a non-GAAP basis is as follows (dollars in millions): Three Months EndedMarch 31, 2024 2023 Operating earnings (loss) - As Reported (GAAP)$(3.2) $5.2 Adjustments: Amortization of intangible assets 20.1 20.0 Share-based compensation 5.9 6.3 Contingent consideration (1.1) (1.6)Depreciation 0.6 0.6 Operating earnings - As Adjusted (non-GAAP)$22.3 $30.5 Non-GAAP adjusted operating earnings adjusts for non-cash items including amortization of intangible assets, share-based compensation expense, change in fair value of contingent consideration, and depreciation. Reconciliation of Full Year 2024 Financial Guidance - GAAP Operating earnings (loss) to Non-GAAP Adjusted Operating earnings (loss) An itemized reconciliation between projected operating earnings (loss) on a GAAP basis and projected adjusted operating earnings on a non-GAAP basis is as follows (dollars in millions): Amount(as of February 27, 2024)Operating earnings (loss) - GAAP$(30) - $0Adjustments: Amortization of intangible assets$80 - $81Share-based compensation$27 - $29Contingent consideration$1 - $2Depreciation$2 - $3Operating earnings - As Adjusted (non-GAAP)$80 - $110 CONTACTS: Jack A. Khattar, President and CEOTimothy C. Dec, Senior Vice President and CFOSupernus Pharmaceuticals, Inc.(301) 838-2591 or INVESTOR CONTACT:Peter VozzoICR Westwicke(443) 213-0505peter.vozzo@westwicke.com