Supernus Reports Q1 2024 Financial Results

Supernus Pharmaceuticals reported its financial results for the first quarter of 2024, revealing significant growth and various strategic updates. The key highlight was the impressive 75% increase in net sales of Qelbree®, reaching $45.1 million compared to the first quarter of 2023. Total revenues stood at $143.6 million, with a 12% rise to $100.7 million in revenues excluding net product sales from Trokendi XR® and Oxtellar XR®. However, there was an operating loss of $3.2 million, though adjusted operating earnings were $22.3 million. The company reiterated its full-year 2024 financial guidance, projecting total revenues between $580 million and $620 million, an operating loss ranging from $30 million to break-even, and adjusted operating earnings between $80 million and $110 million.

Supernus Pharmaceuticals, headquartered in Rockville, Maryland, focuses on developing and commercializing treatments for central nervous system diseases. The President and CEO, Jack Khattar, expressed satisfaction with Qelbree's performance, attributing the success to the company's strategic shift from legacy products to new growth products and advancements in their pipeline.

In terms of business developments, Qelbree prescriptions rose by 31% year-over-year, totaling 176,503 in the first quarter of 2024. The drug is currently undergoing a Phase IV open-label study involving around 500 adults with ADHD and mood symptoms, aiming to measure changes in the Adult ADHD Investigator Symptom Rating Scale (AISRS) over 14 weeks.

The company's product pipeline features several key developments:

1. SPN-830 (apomorphine infusion device) for Parkinson's Disease: The FDA issued a Complete Response Letter for the New Drug Application (NDA), indicating that while the review cycle is complete, the application needs revisions before approval. Supernus plans to discuss resubmission timing with the FDA in May 2024.

2. SPN-820 for Treatment-Resistant Depression: Enrolment for the Phase IIb multi-center study has surpassed the halfway mark. This study involves 268 patients across up to 50 sites, focusing on efficacy and safety over a five-week period, with results expected in the first half of 2025. Additionally, a Phase II open-label study has begun in 40 subjects with major depressive disorder (MDD), assessing efficacy and onset of action.

3. SPN-817 for Epilepsy: Interim data from about 40 patients in the open-label Phase IIa study will be discussed in a conference call scheduled for May 23, 2024. This trial evaluates the safety and efficacy of SPN-817 as an additional therapy for adults with treatment-resistant seizures, with full study results anticipated in the second half of 2024.

4. SPN-443 for ADHD/CNS Disorders: A Phase I single-dose study in healthy adults is slated for 2024, aiming to assess safety and tolerability.

Financially, Supernus reported total net product sales of $138.4 million, a slight decline from $140.6 million in the same period last year, primarily due to reduced sales of Trokendi XR. The company also experienced a 61% drop in royalty and licensing revenues. Despite this, cash and marketable securities increased to approximately $309.4 million by March 31, 2024, up from $271.5 million at the end of 2023, thanks to operational cash flow.

In summary, Supernus Pharmaceuticals demonstrated robust growth for Qelbree and made significant progress in its product pipeline, reinforcing its strategic focus on developing innovative treatments for central nervous system diseases. The company's financial performance, though mixed, indicates a solid foundation for future growth and development.

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