Latest news with #SPN-820
Yahoo
07-05-2025
- Business
- Yahoo
Supernus Pharmaceuticals Inc (SUPN) Q1 2025 Earnings Call Highlights: Strong Revenue Growth ...
The company reported a GAAP net loss of $11.8 million for the first quarter of 2025, compared to net earnings in the prior year quarter. Combined net sales of legacy products Trokendi XR and Oxtellar XR were down 46% in the first quarter, with further erosion expected throughout 2025. The company is advancing its CNS pipeline with plans to initiate a Phase 2b trial for SPN-820 in major depressive disorders, indicating a commitment to R&D and future growth. Qelbree prescriptions grew by 22% and net sales increased by 44% in the first quarter, with a record high of 75,277 monthly prescriptions in March. Story Continues Q & A Highlights Q: Could you please remind us of the key growth drivers for Qelbree in 2025? Is it more about volume or price? Also, could you provide more color on your decision to move forward with SPN-820 in major depressive disorder (MDD)? A: The growth for Qelbree will be driven by both volume and a small price increase. We are optimistic about Qelbree's performance, with prescriptions reaching an all-time high in March. Regarding SPN-820, we expect a placebo-adjusted efficacy delta of five to eight points in MDD, which is clinically significant. We aim to start the study by year-end, with data expected in about a year and a half, depending on recruitment speed. Q: How did normal seasonality impact Qelbree's net pricing in Q1, and what should we expect for the rest of the year? Also, can you comment on the infrastructure for ONAPGO and the timing from start forms to patient prescriptions? A: Q1 typically sees pressure on gross-to-net, with gross-to-net in the early 50s. We expect improvement in Q2 and Q3 unless unforeseen issues arise. We are comfortable with the consensus of $290 million for Qelbree. For ONAPGO, the infrastructure is well-established, and we are optimistic about processing patient enrollment forms efficiently, with conversion rates better than industry average. Q: Could you provide more details on reimbursement discussions for ONAPGO and its differentiation from competitors like the [Habsiz Pump]? A: We expect a high percentage of enrollment forms to be fulfilled, supported by our established infrastructure. ONAPGO offers continuous infusion of apomorphine, a potent dopamine agonist, providing a clear differentiation from Levodopa/Carbidopa pumps. It can be used as an add-on, unlike other pumps, which is a potential advantage. Q: What are you hearing about competitive dynamics for ONAPGO versus [ALIV] and [ABBIE] products? Also, could SPN-443 be used for sleep-wake disorders like narcolepsy? A: Initial feedback for ONAPGO is positive, with strong receptivity from physicians. The differentiation lies in its use of apomorphine, which can be an add-on to existing treatments. For SPN-443, we are considering it for ADHD with potential schedule four classification, but other indications, including sleep-wake disorders, are also being evaluated. Q: Do you have a sense of the proportion of naive patients starting Qelbree for ADHD, and has the combination use in adults changed? A: About 32-33% of Qelbree patients are naive, with the rest being switches, mainly from stimulants. Combination use in adults remains around 35-40%, and we are monitoring if this changes as more data becomes available. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
Reuters
18-02-2025
- Business
- Reuters
Supernus' depression treatment fails mid-stage trial, shares plunge
Feb 18 (Reuters) - Supernus Pharmaceuticals (SUPN.O), opens new tab said on Tuesday its depression treatment trial failed to meet the main goal of reduction in depressive symptoms, sending its shares down 22% aftermarket. The company said the drug, SPN-820, did not show a statistically significant change compared to placebo when tested in 250 patients with treatment-resistant depression during a mid-stage trial. The patients were tested with the Montgomery-Asberg Depression Rating Scale, which measures severity of various symptoms of depression such as sadness, inner tension, reduced sleep and inability to feel. "We will continue to analyze these data and discuss the future of the program with our development partner, Navitor Pharmaceuticals," said Supernus CEO Jack Khattar. here.
