On August 4, 2021 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 2021, and associated Company developments (Press release, Supernus, AUG 4, 2021, View Source [SID1234585714]).

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"The approval and commercial launch of Qelbree for pediatric patients with ADHD mark an important milestone for children and families searching for new treatment options for ADHD," said Jack Khattar, President and CEO of Supernus Pharmaceuticals. "As a non-controlled substance that has a unique profile of proven efficacy, safety and tolerability, Qelbree provides patients living with ADHD a novel treatment option like no other ADHD medication."

Net Product Sales

Second quarter 2021 net product sales were $138.6 million, 12% higher than the same period in 2020.

(1) Net product sales of APOKYN, MYOBLOC and XADAGO from June 9, 2020 to June 30, 2020.

Qelbree Launch Update

At the end of May 2021, Supernus launched Qelbree for the treatment of attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age. Net product sales for the second quarter of 2021 were $0.3 million.
The early performance of Qelbree is on track with our expectations. Current trends in prescriptions reflect the heavy sampling programs with patients. Over 25,000 starter kits have been distributed to physicians since the launch and in preparation for the back-to-school season.
Early clinical feedback about the performance of Qelbree in patients is positive and in line with the Phase III clinical results.
Product Pipeline Update

Qelbree (viloxazine, extended-release capsules) – Novel non-stimulant for the treatment of ADHD in adults

The Company recently submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Qelbree for adult patients with ADHD.
SPN-830 (apomorphine infusion pump) – Continuous treatment of motor fluctuations ("on-off" episodes) in Parkinson’s disease (PD)

The Company continues to plan to resubmit the SPN-830 NDA in the second half of 2021.
SPN-820 – Novel first-in-class activator of mTORC1

A randomized Phase II clinical study of SPN-820 in treatment-resistant depression is expected to start by the end of 2021.
Financial Highlights

Second quarter 2021 operating earnings were $34.1 million, as compared to $45.5 million in the second quarter of 2020. Operating earnings for the second quarter of 2021 included amortization of intangible assets expense of $5.9 million, compared to $2.4 million in the second quarter of 2020.

Second quarter 2021 net earnings and diluted earnings per share were $23.7 million and $0.43, respectively, as compared to $34.7 million, or $0.65 per diluted share, in the same period last year.

As of June 30, 2021, the Company had $855.3 million in cash, cash equivalents, current and long-term marketable securities, compared to $772.9 million as of December 31, 2020.

Full Year 2021 Financial Guidance

For full year 2021, the Company reiterates its prior financial guidance including an increase to the lower end of its operating earnings guidance as set forth below:

(1) Total revenues include net product sales and royalty revenue. Includes $10 million for Qelbree net product sales.
(2) Combined research and development and selling, general and administrative expenses.
(3) Operating earnings include amortization of intangible assets and contingent consideration expense (gain). Reflects an increase from the original guidance of $65 – $90 million.
(4) The full year 2021 effective tax rate guidance of 28% – 31% is above the normally expected range of 26% – 28% due to the effect of discrete tax items in the period.

Conference Call Details

The Company will hold a conference call hosted by Jack Khattar, President and Chief Executive Officer and Jim Kelly, Executive Vice President and Chief Financial Officer, to discuss these results at 4:30 p.m. Eastern Time, today, August 4, 2021.

Please refer to the information below for conference call dial-in information and webcast registration. Callers should dial in approximately 10 minutes prior to the start of the call.

Following the live call, a replay will be available on the Company’s website, www.supernus.com, under "Investor Relations".