On August 4, 2022 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 second quarter of 2022, and associated Company developments (Press release, Supernus, AUG 4, 2022, View Source [SID1234617529]).

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Qelbree Launch Update

Total IQVIA prescriptions were 62,938 in the second quarter of 2022, an increase of 33% compared to total prescriptions of 47,324 in the first quarter of 2022. In June 2022, the most recent month available, total prescriptions reached 23,403.
Qelbree continues to expand its base of prescribers, with approximately 9,276 prescribers in the second quarter of 2022, up from 6,900 prescribers from the first quarter of 2022.
Continued progress in securing and improving managed care coverage.
Supernus launched Qelbree for adult patients in May 2022.
Product Pipeline Update

SPN-830 (apomorphine infusion device) – Continuous treatment of motor fluctuations ("off" episodes) in Parkinson’s disease (PD)

The Company continues to work closely with the U.S. Food and Drug Administration (FDA) as it reviews the New Drug Application (NDA) resubmission for SPN-830 for the continuous treatment of motor fluctuations ("off" episodes) in Parkinson’s disease. The Company is preparing for the commercial launch of SPN-830 in the first quarter of 2023, assuming timely approval by the FDA. The FDA has established a PDUFA target action date in early October 2022.
SPN-820 – Novel first-in-class activator of mTORC1

The Company continues to enroll patients in a Phase II multi-center, randomized double-blind placebo-controlled parallel design study of SPN-820 in adults with treatment-resistant depression. The study will examine the efficacy and safety of SPN-820 over a course of five weeks of treatment in approximately 270 patients. The primary outcome measure is the change from baseline to end of treatment period on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score, a standard depression rating scale.
SPN-817 – A novel product candidate for the treatment of epilepsy

An open-label Phase II clinical study of SPN-817 in patients with treatment-resistant seizures is expected to start in the fourth quarter of 2022.
Financial Highlights

Net Product Sales

For the three months ended June 30, 2022, net product sales were $165.5 million, a 19% increase over $138.6 million for the same period in 2021. For the six months ended June 30, 2022, net product sales were $312.9 million, a 17% increase over $267.0 million for the same period in 2021. The increases in both periods were primarily due to net product sales of GOCOVRI and growth in net product sales of Qelbree and Oxtellar XR.

The following table provides information regarding our net product sales during the three and six months ended June 30, 2022 and 2021 (dollars in millions):

Operating earnings (GAAP and non-GAAP)

For the three months ended June 30, 2022 operating earnings (GAAP) were $11.3 million, as compared to $34.1 million for the same period in 2021. For the six months ended June 30, 2022 operating earnings (GAAP) were $13.3 million, as compared to $47.3 million for the same period in 2021. The decreases in both periods were primarily due to activities to support the launch of Qelbree, costs associated with GOCOVRI and amortization of acquired intangible assets from the Adamas Acquisition.

For the three months ended June 30, 2022, adjusted operating earnings (non-GAAP) were $37.6 million, compared to $37.4 million in the second quarter of 2021. For the six months ended June 30, 2022, adjusted operating earnings (non-GAAP) was $65.7 million, compared to $62.7 million in the second quarter of 2021.

Reconciliation of GAAP to Non-GAAP Adjustments

An itemized reconciliation between operating earnings on a GAAP basis and operating earnings on a non-GAAP basis is as follows (dollars in millions):

Non-GAAP operating earnings adjusts for non-cash items including amortization of intangible assets, share-based compensation expense, change in fair value of contingent consideration, and depreciation. Included in the amortization of intangible assets for the three and six months period ended June 30, 2022 was amortization of acquired intangible assets from the Adamas Acquisition in November 2021.

Net earnings (GAAP)

For the three months ended June 30, 2022, net earnings (GAAP) and diluted earnings per share (GAAP) were $7.9 million and $0.14, respectively, as compared to $23.7 million, or $0.43 per diluted share, in the same period in 2021.

For the six months ended June 30, 2022, net earnings (GAAP) and diluted earnings per share (GAAP) were $33.5 million and $0.57, respectively, as compared to $29.4 million, or $0.54 per diluted share, in the same period in 2021.

Cash, cash equivalents and marketable securities

At June 30, 2022, the Company’s cash, cash equivalents, current and long-term marketable securities are approximately $508.2 million, compared to $458.8 million as of December 31, 2021. This increase was primarily due to cash generated from operations.

Full Year 2022 Financial Guidance (GAAP)

For full year 2022, the Company reiterates its prior financial guidance as set forth below (dollars in millions):

Full Year 2022 Financial Guidance – GAAP to Non-GAAP Adjustments

An itemized reconciliation between projected operating earnings on a GAAP basis and projected operating earnings on a non-GAAP basis is as follows (dollars in millions):

Non-GAAP Financial Information

This press release contains a financial measure, non-GAAP operating earnings, which does not comply with United States generally accepted accounting principles (GAAP). The non-GAAP financial measure 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 operating earnings adjust for non-cash share-based compensation expense, depreciation and amortization, and accretion of contingent consideration, and for factors that are unusual, non-recurring or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables in this press release. We believe the use of non-GAAP operating earnings is useful supplemental information to investors regarding the Company’s results of operations and assist management, analysts, and investors in evaluating the performance of the business. There are limitations associated with the use of non-GAAP financial measures. Including such measures may not be entirely comparable to similarly titled measures used by other companies, may not reflect all items of income and expense, as applicable, that affect our operations, potential differences among calculation methodologies, may differ from the non-GAAP information used by other companies, including peer companies, and therefore comparability may be limited. 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 2022 financial guidance is also being provided on both a reported and a non-GAAP basis.

Conference Call Details

Supernus will host a conference call and webcast today, August 4, 2022, at 4:30 p.m. Eastern Time to discuss these results.

A live webcast will be available in the Events & Presentation 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.