After U.S. markets closed for trading yesterday, Supernus Pharmaceuticals Inc. (SUPN:NASDAQ), which develops and commercializes products used to treat central nervous system (CNS) diseases, announced financial and operating results for the third quarter of 2020 ended September 30. 2020.
The company's President and CEO Jack Khattar commented, "During the first nine months of 2020, we delivered strong product sales growth, diversified our revenue base and enhanced our long term growth with two corporate transactions...Our employees have been hard at work in anticipation of the launch of SPN-812. Based on the efficacy and safety demonstrated in its clinical program, SPN-812 can potentially offer an important new option in the treatment of ADHD."
Supernus Pharmaceuticals reported that in Q3/20 net product sales increased by 52% to $152.1 million, compared to $100.0 million in Q3/19. The company noted that the bulk of the increase was attributable to the addition of $40.9 million of net product sales from acquired commercial products. Additionally, the firm said that net product sales of Trokendi XR and Oxtellar XR grew by $11.2 million. The company also indicated that royal revenues increased to $3.0 million in Q3/20, compared to $2.1 million in Q3/19.
Supernus stated that TSPN-812, a novel non-stimulant for the treatment of ADHD in children and adults, is on track to be launched commercially in January 2021, if approved by the U.S. Food and Drug Administration (FDA). The firm noted that "the New Drug Application (NDA) Prescription Drug User Fee Act (PDUFA) target action date is November 8, 2020."
The firm listed that a NDA was submitted to the FDA in September 2020 for its SPN-830 (Apomorphine infusion pump), used for continuous treatment of motor fluctuations in Parkinson's disease (PD). The company said it anticipates that it will be ready to launch SPN-830 in Q4/21 if the FDA grants approval.
The company further explained that by the end of next year it hopes to initiate a Phase 2 clinical program for SPN-820, a novel first-in-class activator of mTORC1 for treatment-resistant depression.
The company reported that in Q3/20 it posted GAAP operating earnings of $56.1 million, compared to $39.7 in Q3/19. The firm advised also that it recorded GAAP net earnings of $40.0 million, or $0.74 per diluted share in Q3/20, compared to $28.9 million, or $0.54 per diluted share in Q3/19.
The firm reported that it had cash, cash equivalents and marketable securities of $740.1 million available as of September 30, 2020. The company advised that the balances decreased from $938.8 million on December 31, 2019 due mostly to the cash payments made in the amount of $300 million to acquire the CNS portfolio of US WorldMeds and another $25 million that was paid to Navitor for the development and option agreement for SPN-820.
Supernus Pharmaceuticals indicated that it has revised its FY/20 financial guidance, which includes the impacts from acquiring the CNS portfolio of US WorldMeds in June 2020. The company stated that it now expects FY/20 net product sale of $500-525 million and GAAP operating earnings of $145-160 million. These estimates represent an increase compared with the estimates the firm provided in August 2020 that called for FY/20 net product sales of $460-500 million and GAAP operating earnings of $90-110 million.
Supernus Pharmaceuticals concentrates its efforts on creating and marketing products utilized for treating central nervous system (CNS) diseases. The company noted that at present, "it markets Trokendi XR® (extended-release topiramate) for the prophylaxis of migraine and the treatment of epilepsy; Oxtellar XR® (extended-release oxcarbazepine) for the treatment of epilepsy; APOKYN® (apomorphine hydrochloride injection) for the acute treatment of hypomobility in advanced Parkinson's disease (PD); MYOBLOC® (rimabotulinumtoxinB) for the treatment of cervical dystonia and treatment of chronic sialorrhea in adults; and XADAGO® (safinamide) as an adjunctive treatment to levodopa/carbidopa in PD patients with hypomobility." The firm also noted that it is in the process of developing other candidates to treat CNS indication in several other areas including ADHD, epilepsy, hypomobility in PD, and treatment-resistant depression.
Supernus Pharma started the day with a market capitalization of around $955.9 million with approximately 52.66 million shares outstanding and a short interest of about 9.7%. SUPN shares opened 17.6 % higher today at $21.35 (+$3.20, +17.63%) over yesterday's $18.15 closing price. The stock has traded today between $20.22 and $22.87 per share and is currently trading at $22.00 (+$3.85, +21.21%).[NLINSERT]
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