On May 6, 2025 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported financial results for the first quarter 2025 and associated Company developments (Press release, Supernus, MAY 6, 2025, View Source [SID1234652596]).

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"Our first quarter results reflect, once again, double-digit revenue growth from our core products, as well as strong growth in adjusted operating earnings," said Jack Khattar, President and CEO of Supernus. "In addition, we are pleased to be bringing ONAPGO to market, another growth driver for our business. ONAPGO represents a novel approach for adults with Parkinson’s disease who are experiencing motor fluctuations."

Commercial Highlights

Total IQVIA prescriptions(2) for Qelbree were 214,908 for the first quarter 2025, an increase of 22% compared to the same period in the prior year. For March 2025, total monthly prescriptions reached an all-time high of 75,277. Qelbree continues to expand its base of prescribers, with approximately 34,416 prescribers in the first quarter of 2025, up from 27,902 prescribers in the same period last year.

In April 2025, the Company launched ONAPGO, the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson’s disease. Initial physician response is encouraging based on very early activity in the launch.
Product Pipeline Update

SPN-817 – Novel first-in-class highly selective AChE inhibitor for epilepsy

The Phase 2b randomized, double-blind, placebo-controlled study of 3mg and 4mg twice daily doses is ongoing with a targeted enrollment of approximately 258 adult patients with treatment resistant focal seizures.
SPN-820 – Novel first-in-class molecule that increases mTORC1 mediated synaptic function for depression

The Company plans to initiate a follow-on Phase 2b multi-center, randomized, double-blind, placebo-controlled trial in approximately 200 adults with major depressive disorder (MDD). The study will examine the safety and tolerability of SPN-820 2400 mg given intermittently (twice weekly) as an adjunctive treatment to the current baseline antidepressant therapy, as well as assess the rapid onset of improvement in depressive symptoms.
SPN-443 – Novel stimulant for ADHD/CNS

The Company completed a Phase 1 pharmacokinetic study of two oral formulations in healthy adults. Both formulations of SPN-443 showed adequate bioavailability and were well tolerated. The Company expects to disclose a lead indication for the product candidate by the end of 2025.
Financial Highlights

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 Ended
March 31,
2025 2024 Change %
(unaudited)
Net product sales
Qelbree $ 64.7 $ 45.1 44 %
GOCOVRI 30.7 26.5 16 %
APOKYN 15.0 16.7 (10 )%
Trokendi XR 12.8 16.0 (20 )%
Oxtellar XR 10.2 26.9 (62 )%
Other(3) 8.6 7.2 19 %
Total net product sales 142.0 138.4 3 %
Royalty, licensing and other revenues(4) 7.8 5.2 51 %
Total revenues $ 149.8 $ 143.6 4 %

Total revenues excluding Trokendi XR and Oxtellar XR net sales (non-GAAP)(1) $ 126.8 $ 100.7 26 %

Other Financial Highlights

Operating loss was $(10.3) million for the three months ended March 31, 2025, compared to operating loss of $(3.2) million for the same period in 2024. The change was primarily due to higher contingent consideration loss, mainly related to the achievement of ONAPGO-related milestones, and higher selling and marketing expenses.
Adjusted operating earnings (non-GAAP) were $25.9 million for the three months ended March 31, 2025, compared to $22.3 million for the same period in 2024.
Net loss and diluted loss per share were $(11.8) million and $(0.21) for the three months ended March 31, 2025, compared to net earnings and diluted earnings per share of $0.1 million and $0.00 for the three months ended March 31, 2024.
At March 31, 2025, cash, cash equivalents, and current and long-term marketable securities were approximately $463.6 million compared to $453.6 million as of December 31, 2024. This increase was primarily due to cash generated from operations partially offset by the $25.0 million payment of ONAPGO-related milestone in the first quarter of 2025.
Full Year 2025 Financial Guidance

For the full year 2025, the Company reiterates its full year financial guidance as set forth below (dollars in millions):

Current Guidance
(as of February 25, 2025)
Total revenues (includes approximately $65 million – $75 million of Trokendi XR and Oxtellar XR)(5)(6) $600 – $630
Combined R&D and SG&A expenses $435 – $460
Operating earnings (loss) $(15) – $10
Adjusted operating earnings (non-GAAP)(1) $105 – $130