On February 25, 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 fourth quarter and full year 2024 and associated Company developments (Press release, Supernus, FEB 25, 2025, View Source [SID1234650545]).
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"Our 2024 results reflect solid commercial execution across the company, including continued growth of our core products, and strong growth in operating earnings," said Jack Khattar, President and CEO of Supernus. "In 2025, we look forward to continued Qelbree growth; the launch of ONAPGO for the treatment of Parkinson’s disease, planned for the second quarter of 2025; and further advancement of our product pipeline."
Qelbree Highlights
The U.S. Food and Drug Administration (FDA) has approved an update for the label for Qelbree to include new pharmacodynamic data. The updated label highlights Qelbree’s partial agonist activity at the serotonin 5-HT2C receptor and inhibition of the norepinephrine transporter, reinforcing its multimodal pharmacodynamic profile. Additionally, the updated label now includes new lactation data for breastfeeding women with attention-deficit/hyperactivity disorder (ADHD), showing that the transfer of Qelbree into breastmilk is low.
The Company recently presented interim results from an open-label Phase IV trial with Qelbree in 161 adults with ADHD and mood symptoms at the 30th Annual National Psychopharmacology Update conference. The improvements in clinician and patient-rated measures of ADHD, depression and anxiety symptoms in the interim data analysis, analyzed for the first 95 patients who completed the trial, are encouraging and suggest that Qelbree’s effects may extend to adults with complex ADHD. Efficacy and safety outcomes were consistent with the double-blind, pivotal trial of Qelbree in adult ADHD. Topline results from the full Phase IV trial (all 161 adults) are consistent with the interim results and will be presented at the American Psychiatric Association Annual Meeting in May 2025.
Total IQVIA prescriptions(2) for Qelbree were 214,613 and 767,791 for the fourth quarter and full year of 2024, respectively, an increase of 25% for both periods compared to the same periods in the prior year.
The Company received a two-plus year patent term extension from the US Patent and Trademark Office for US Patent number 9,662,338 that covers Qelbree. This extends the original expiration date of the patent to the year 2035.
Product Pipeline Update
ONAPGO (formerly, SPN-830) (apomorphine infusion device) for treatment of Parkinson’s disease (PD)
The Company announced in early February 2025 that the FDA approved ONAPGO (apomorphine hydrochloride), formerly known as SPN-830, as the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced PD. The Company plans to launch ONAPGO in the second quarter of 2025 with a support team of experts, including a robust nurse education program, and access support.
SPN-817 – Novel first-in-class highly selective AChE inhibitor for epilepsy
In November 2024, the Company reported topline results from an open label Phase 2a study in patients with treatment-resistant seizures. The study suggested a differentiated profile, with strong efficacy in focal seizures at the 3mg to 4mg twice daily doses. SPN-817 was safe and had acceptable tolerability with two subjects discontinuing because of treatment related adverse events out of the 26 subjects who entered the maintenance period.
The Company has initiated a Phase 2b randomized, double-blind, placebo-controlled study of 3mg and 4mg twice daily doses 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
In February 2025, the Company reported topline results from a randomized double-blind placebo-controlled Phase 2b study of SPN-820 in adults with treatment-resistant depression (TRD). The study did not demonstrate a statistically significant improvement on the primary and secondary endpoints. The safety profile of SPN-820 was consistent with previous clinical trials, showing few adverse events. The Company will continue to analyze the data and decide on the future of the program.
SPN-443 – Novel stimulant for ADHD/CNS
Supernus 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.
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 December 31, Year Ended
December 31,
2024 2023 Change % 2024 2023 Change %
Net product sales
Qelbree $ 74.4 $ 46.4 60% $ 241.3 $ 140.2 72%
GOCOVRI 36.9 32.0 15% 130.8 119.6 9%
Oxtellar XR 13.2 31.0 (57)% 99.5 113.4 (12)%
APOKYN 20.1 18.7 8% 73.9 75.1 (2)%
Trokendi XR 14.8 19.6 (24)% 63.2 94.3 (33)%
Other(3) 7.0 8.3 (16)% 29.0 31.3 (7)%
Total net product sales $ 166.4 $ 156.0 7% $ 637.7 $ 573.9 11%
Royalty, licensing and other revenues(4) 7.8 8.3 (6)% 24.1 33.6 (28)%
Total revenues $ 174.2 $ 164.3 6% $ 661.8 $ 607.5 9%
Total revenues excluding Trokendi XR and Oxtellar XR net product sales (non-GAAP)(1) $ 146.2 $ 113.7 29% $ 499.1 $ 399.8 25%
Total revenues were $174.2 million and $661.8 million for the three and twelve months ended December 31, 2024, compared to $164.3 million and $607.5 million in the same periods in 2023, respectively.
Total net product sales were $166.4 million and $637.7 million for the three and twelve months ended December 31, 2024, compared to $156.0 million and $573.9 million in the same periods in 2023, respectively. The increase in both periods was primarily due to increases in net sales of Qelbree and GOCOVRI, partially offset by the decline in net product sales of Trokendi XR and Oxtellar XR due to generic erosion.
Total revenues excluding Trokendi XR and Oxtellar XR net product sales (non-GAAP) increased 29% and 25% for the three and twelve months ended December 31, 2024, compared to the same periods in 2023, respectively.
Other Financial Highlights
Operating earnings were $21.4 million and $81.7 million for the three and twelve months ended December 31, 2024, compared to operating loss of $(1.0) million and $(5.3) million for the same periods in 2023, respectively. The positive increase in both periods was primarily due to an increase in total net product sales. Furthermore, the fourth quarter of 2023 included $20.2 million in intangible asset impairment charges, mainly related to XADAGO.
Adjusted operating earnings (non-GAAP) were $48.3 million and $183.7 million for the three and twelve months ended December 31, 2024, compared to $47.1 million and $125.1 million for the same periods in 2023, respectively.
Net earnings and diluted earnings per share were $15.3 million and $0.27 for the three months and $73.9 million and $1.32 for the twelve months ended December 31, 2024, respectively, compared to net earnings and diluted earnings per share of $1.2 million and $0.02 for the three months and $1.3 million and $0.02 for the twelve months ended December 31, 2023, respectively.
At December 31, 2024, cash, cash equivalents, and current and long-term marketable securities were approximately $453.6 million compared to $271.5 million as of December 31, 2023. This increase was primarily due to cash generated from operations.
Full Year 2025 Financial Guidance
For the full year 2025, the Company is providing the financial guidance for total revenues and operating earnings (GAAP and Non-GAAP) 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
Non-GAAP Financial Information
This press release contains financial measures that present financial information which do not comply with United States generally accepted accounting principles (GAAP). The non-GAAP financial measures should be considered in addition to, not as a substitute for or in isolation from, or superior to measures prepared in accordance with GAAP. Non-GAAP adjusted operating earnings on a historical and projected basis adjusts for non-cash share-based compensation expense, depreciation and amortization, intangible asset impairment charges and changes to fair value of contingent consideration, and for factors that are unusual, non-recurring or unpredictable, and excludes those costs, expenses, and other specified items presented in the reconciliation tables in this press release. In addition to non-GAAP adjusted operating earnings, we also present total revenues excluding net product sales of Trokendi XR (GAAP) and Oxtellar XR (GAAP), which is a non-GAAP measure and is calculated as total revenues (GAAP) less net product sales of Trokendi XR (GAAP) and Oxtellar XR (GAAP). Beginning in the year a product loses exclusivity due to generic entrants we generally do not expect net product sales of such products to constitute a significant part of our revenue in the future. We believe that the use of non-GAAP financial measures provides useful supplemental information to management, investors, analysts and others regarding the Company’s revenue and results of operations and assist management, investors, analysts, and others in understanding and evaluating our revenue growth and the performance of the business.
There are limitations associated with the use of non-GAAP financial measures and therefore comparability may be limited. These limitations include: non-GAAP financial measures that may not be entirely comparable to similarly titled measures used by other companies; these may not reflect all items of income and expense, as applicable, that affect our operations; there may be potential differences among calculation methodologies; these may differ from the non-GAAP information used by other companies, including peer companies. We mitigate these limitations by reconciling the non-GAAP financial measure to the most comparable GAAP financial measure. Investors are encouraged to review the reconciliation. The Company’s 2024 financial guidance is also being provided on both a GAAP and a non-GAAP basis.
End Notes
(1) See the section titled "Non-GAAP Financial Information" for information about this non-GAAP financial measure. A reconciliation of each non-GAAP financial measure to the most directly comparable GAAP financial measure is included at the end of this press release.
(2) IQVIA data restatement July 1, 2024.
(3) Includes net product sales of MYOBLOC, XADAGO and Osmolex ER.
(4) Royalty, licensing, and other revenues include royalties on generic Trokendi XR, other licensed products and intellectual property.
(5) Includes net product sales and royalty, licensing, and other revenue.
(6) Reflects continued generic erosion of Trokendi XR and generic erosion of Oxtellar XR beginning in September 2024.
Conference Call Details
Supernus will host a conference call and webcast today, February 25, 2025, at 4:30 p.m. Eastern Time to discuss these results.
A live webcast will be available in the Events & Presentations section of the Company’s Investor Relations website www.supernus.com/investors.
Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.
Following the live call, a replay will be available on the Company’s Investor Relations website www.supernus.com/investors. The webcast will be available on the Company’s website for 60 days following the live call.