Financial Data and Key Metrics Changes - Total revenue for Q3 2024 was $175.7 million, up from $153.9 million in Q3 2023, driven by net product sales of $170.3 million and royalty and other revenues of $5.4 million [19] - Operating earnings on a GAAP basis for Q3 2024 were $40.9 million, compared to $8.1 million in the same quarter last year, marking a $32.8 million increase [21] - GAAP net earnings were $38.5 million for Q3 2024, or $0.69 per diluted share, compared to a net loss of $16 million or $0.29 loss per diluted share in Q3 2023 [22] Business Line Data and Key Metrics Changes - Qelbree's net sales increased by 68% in Q3 2024, reaching $62 million, with prescriptions growing by 19% [6][8] - GOCOVRI's net sales increased to $36 million in Q3 2024, representing an 8% growth over the same period in 2023 [8] - Oxtellar XR's net sales were $30 million, flat compared to Q3 2023, while Trokendi XR's net sales decreased by 26% to $15 million [9] Market Data and Key Metrics Changes - Qelbree's prescriptions reached an all-time quarterly high of 194,000, with a 14% growth in September compared to June [6][7] - For the first nine months of 2024, Qelbree's prescriptions grew by 25%, outpacing the ADHD market's growth of 9% [8] Company Strategy and Development Direction - The company is focused on advancing its product pipeline, with several catalysts expected in the near to midterm [11] - The company is actively seeking strategic opportunities for growth, particularly in the CNS sector, while also considering other therapeutic areas [18][54] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the performance of Qelbree and its growth trajectory, indicating strong retention and compliance rates [47] - The company raised its financial guidance for 2024, expecting total revenues to range from $630 million to $650 million [28] Other Important Information - The company had approximately $403.2 million in cash and marketable securities as of September 30, 2024, compared to $271.5 million at the end of 2023, indicating strong financial flexibility [27] - The company expects further erosion in Trokendi XR sales and has raised the target combined net sales for Trokendi XR and Oxtellar XR to approximately $155 million for 2024 [10] Q&A Session Summary Question: Overall seizure reduction for SPN-817 - Management confirmed that the maintenance period showed a 56% seizure reduction, with improvements noted in the post-maintenance period [32][34] Question: Impact of AbbVie's pump approval on the company's pump - Management expressed excitement about the market education that AbbVie's approval could bring and the potential for both products to coexist in the market [36][37] Question: Expectations for SPN-820 in TRD study - Management indicated that while it is difficult to predict, they are hopeful for strong results based on previous data [39][40] Question: Qelbree's growth trajectory and pricing - Management reported strong growth in Qelbree prescriptions and healthy net pricing, with optimism for continued performance into 2025 [41][46] Question: Capital deployment and M&A strategy - The company prioritizes acquiring commercial products for revenue growth, followed by pipeline assets at later stages [52] Question: Competitive landscape for Qelbree - Management acknowledged that competition will arise but emphasized the importance of product profiles and patient demographics in assessing impact [55]

Supernus Pharmaceuticals (SUPN) came out with quarterly earnings of $1.06 per share, beating the Zacks Consensus Estimate of $0.39 per share. This compares to loss of $0.29 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 171.79%. A quarter ago, it was expected that this drugmaker would post earnings of $0.37 per share when it actually produced earnings of $0.36, delivering a surprise of -2.70%.Over the last four quarters, the ...

Core Insights - Supernus Pharmaceuticals presented new data on SPN-820, a novel treatment for major depressive disorder (MDD), at Psych Congress 2024, highlighting its rapid onset and favorable safety profile [1][5][6] Study Results - The Phase 2a study involved 40 subjects with MDD, assessing the efficacy and safety of SPN-820 administered at 2400 mg every three days [7] - Participants showed significant reductions in depressive symptoms, with a decrease of 80% in suicidal ideation from 12.5% at baseline to 2.6% by Day 10 [4] - The Hamilton Depression Rating Scale-6 items (HAM-D6) showed improvements of -6.1 at two hours and -9.6 at Day 10, while the Montgomery Åsberg Depression Rating Scale (MADRS) indicated improvements of -16.6 at four hours and -22.9 at Day 10 [2] Efficacy and Tolerability - Rapid response rates were observed, with 50% of participants achieving a ≥50% reduction in MADRS scores at four hours, increasing to 84.2% by Day 10 [3] - The tolerability profile was favorable, with a low discontinuation rate of 2.5% due to adverse events, which were mostly mild to moderate [4][5] Mechanism of Action - SPN-820 is a first-in-class, orally active small molecule that modulates the mTORC1 pathway, enhancing synaptic function and cellular metabolism in the brain [6] - The compound is designed to provide rapid antidepressant effects without dissociative side effects, with ongoing Phase 2b studies involving approximately 227 patients with treatment-resistant depression [6]

ROCKVILLE, Md., Oct. 21, 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 that the Company expects to report financial and business results for the third quarter of 2024 after the market closes on Monday, November 4, 2024. Jack Khattar, President and CEO, and Tim Dec, Senior Vice President and CFO, will host a conference call to pre ...

Core Insights - Supernus Pharmaceuticals announced positive results from its Phase 2a clinical study of SPN-820, a novel treatment for major depressive disorder, demonstrating a rapid and substantial decrease in depressive symptoms [1][3] - The company plans to host a webcast to discuss the topline data and expects to release results from a Phase 2b study in the first half of 2025 [1][3] Study Results - The Phase 2a study involved 40 subjects, with 38 completing the treatment, showing a clinically meaningful improvement of -6.1 at two hours and -9.6 at Day 10 on the Hamilton Depression Rating Scale-6 Items (HAM-D6) [2][6] - On the Montgomery Åsberg Depression Rating Scale (MADRS), improvements of -16.6 at four hours and -22.9 at Day 10 were observed [2] - Suicidal ideation decreased by 80%, from 12.5% at baseline to 2.6% at Day 10 [2] Safety and Tolerability - SPN-820 was well-tolerated, with a low discontinuation rate of 2.5% due to adverse events [2] - Common adverse events included headache, nausea, somnolence, and dizziness, with additional events such as cognitive disorder and dry mouth reported [2] Product Overview - SPN-820 is a first-in-class, orally active small molecule that enhances synaptic function via mTORC1 modulation, aiming for rapid antidepressant effects without dissociative side effects [5] - The ongoing Phase 2b study will involve approximately 227 adult patients with treatment-resistant depression [5]

ROCKVILLE, Md., Oct. 10, 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 that the Company will hold a webcast and conference call on Thursday, October 17, 2024, at 4:30 p.m. ET to review data from the open-label Phase 2a study of SPN-820 for the treatment of major depressive disorder. A live webcast with presentation slides will be ...

Core Insights - The article highlights the importance of raising awareness about ADHD, particularly in women, and emphasizes the role of Qelbree as a treatment option for managing ADHD symptoms [1][2][3] Company Overview - Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing treatments for central nervous system (CNS) diseases, including ADHD [11] - The company is committed to providing treatment options and education for individuals living with ADHD, as stated by its CEO, Jack A. Khattar [4] Product Information - Qelbree (viloxazine extended-release capsules) is a non-stimulant medication approved for the treatment of ADHD in patients aged 6 years and older, marking the first non-stimulant approved for adults in 20 years [3][5] - Qelbree is designed to be taken once daily and has no evidence of abuse or misuse, allowing for convenient refills without the need for a new prescription each month [3] Market Context - Approximately 10 million adults in the U.S. live with ADHD, and the article emphasizes the challenges they face in managing their symptoms, particularly during transitions like the start of the school year [2] - The article aims to empower individuals, especially women, to seek treatment options and advocate for their health [2][3]

Simon Webb and Duncan Nicholls/OJO Images via Getty Images Investment Overview The last - and also the first - time I covered Supernus Pharmaceuticals (NASDAQ:SUPN) for Seeking Alpha was in November 2023. I gave the company's stock a "strong buy" rating - shares traded at $26 at the time - and at the time of writing they trade at a value of $30 - up ~15%. I own some stock in the company myself. At the end of last week, shares actually traded at $35 per share - up 35% since my note - however the market has b ...

Piper Sandler downgraded Supernus Pharmaceuticals Inc SUPN, saying that the anticipated surge in Qelbree prescriptions during the back-to-school season has not materialized as expected. "That has us rethinking our assumptions regarding the longer-term (LT) sales/volume growth trajectory of the product," the analyst adds. Qelbree (viloxazine) is indicated to treat attention deficit hyperactivity disorder in children and adults. In the second quarter of 2024, net sales of Qelbree increased 92% year over year ...

ROCKVILLE, Md., Aug. 28, 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, announced today that Jack Khattar, President and CEO of Supernus Pharmaceuticals, will participate in a fireside chat at the Wells Fargo Healthcare Conference on Wednesday, September 4, 2024, at 4:30 p.m. ET at the Encore Boston Harbor Hotel in Everett, Massachusetts. Investo ...