• Supernus Announces First Quarter 2021 Financial Results

    المصدر: Nasdaq GlobeNewswire / 05 مايو 2021 16:01:00   America/New_York

    • First quarter 2021 total revenues of $130.9 million, a 38% increase compared to 2020
    • Qelbree™ approved by FDA for pediatric ADHD and on track for a U.S. launch in Q2 2021
    • Qelbree sNDA submission for adult ADHD anticipated in the third quarter of 2021
    • SPN-830 (apomorphine infusion pump) NDA resubmission anticipated in the second half of 2021
    • SPN-820 (mTORC1) has advanced towards a Phase II clinical program in treatment-resistant depression following successful completion of MAD study

    ROCKVILLE, Md., May 05, 2021 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today reported financial results for the first quarter of 2021, and associated Company developments.

    “The approval of Qelbree provides pediatric patients living with ADHD a therapy with proven efficacy and a tolerable safety profile, and that is not a controlled substance,” said Jack Khattar, President and CEO of Supernus Pharmaceuticals. “Our Qelbree commercial launch activities are ongoing and include engagement with both physicians and patient groups who have expressed great interest in this unique new alternative for the treatment of ADHD.”

    Net Product Sales

    First quarter 2021 net product sales were $128.4 million, 39% higher than the same period in 2020.

    Net Product Sales     
    ($ in millions)Q1 2021 Q1 2020 Change %
    Trokendi XR®$71.8  $68.6  5%
    Oxtellar XR®27.4  23.9  14%
    APOKYN®21.7  —  ** 
    MYOBLOC®4.3  —  ** 
    XADAGO®3.2  —  ** 
    Net Product Sales$128.4  $92.5  39%

    Qelbree Launch Update

    • In April 2021, the U.S. Food and Drug Administration (FDA) approved Qelbree for the treatment of attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age. The Company plans to make Qelbree available in the U.S. during the second quarter of 2021.
    • Supernus will conduct post-marketing commitment studies, including a new study of Qelbree in preschool aged children with ADHD, 4 to 5 years of age. The completion of these studies responds to a written request from the FDA and should therefore result in the FDA granting an additional 6 months of market exclusivity.

    Product Pipeline Update

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

    • In December 2020, the Company announced positive results from a Phase III trial in adult patients with ADHD and plans to submit a supplemental New Drug Application (sNDA) to the FDA for Qelbree in adults in the third quarter of 2021.

    SPN-830 (apomorphine infusion pump) - Continuous treatment of motor fluctuations (“on-off” episodes) in PD

    • The company recently met with the FDA to discuss the path forward for resubmission of the SPN-830 NDA. The FDA provided additional clarity related to the contents of the November 2020 Refusal to File (RTF) letter and the requirements for resubmission. The Company now plans to resubmit the SPN-830 NDA in the second half of 2021.

    SPN-820 - Novel first-in-class activator of mTORC1

    • SPN-820 has advanced to a Phase II clinical program in treatment-resistant depression following the successful completion of a multiple-ascending dose (MAD) study in healthy volunteers. In the MAD study, SPN-820 exhibited a favorable safety and tolerability profile across a broad range of potentially therapeutic doses.
    • The Company expects to initiate a randomized Phase II clinical study in treatment-resistant depression by the end of 2021.

    Financial Highlights

    First quarter 2021 operating earnings were $13.2 million, as compared to $29.0 million in the first quarter 2020. In the first quarter of 2021, the Company recorded non-cash research and development expense of $15 million related to the equity investment in Navitor as a result of the accounting impact of the March 2021 Navitor corporate restructuring and non-cash contingent consideration expense of $1 million associated with the 2020 USWM acquisition. Operating earnings for the first quarter of 2021 included amortization of intangible assets expense of $6.0 million, compared to $1.3 million in the first quarter of 2020.

    First quarter 2021 net earnings and diluted earnings per share were $5.7 million and $0.11, respectively, as compared to $21.5 million, or $0.40 per diluted share, in the same period last year.

    As of March 31, 2021, the Company had $807.7 million in cash, cash equivalents and 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 and added full year 2021 effective tax rate guidance as set forth below:

     Full Year 2021 Guidance
    ($ in millions)
    Total revenues1$550 - $580
    Combined R&D and SG&A expenses2$380 - $410
    Operating earnings3$65 - $90
    Amortization of intangible assets$24
    Effective Tax Rate428% - 31%

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    1)   Total revenues includes 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.
    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, May 5, 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.

    Conference dial-in:(877) 288-1043
    International dial-in:(970) 315-0267
    Conference ID:9275942
    Conference Call Name:Supernus Pharmaceuticals First Quarter 2021 Results Conference Call

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

    About Supernus Pharmaceuticals, Inc.

    Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.

    Our diverse neuroscience portfolio includes approved treatments for epilepsy, migraine, ADHD, hypomobility in Parkinson’s disease, cervical dystonia and chronic sialorrhea. We are developing a broad range of novel CNS product candidates including new potential treatments for hypomobility in Parkinson’s disease, epilepsy, depression, and rare CNS disorders.

    For more information, please visit www.supernus.com

    Forward-Looking Statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not convey historical information but relate to predicted or potential future events that are based upon management's current expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In addition to the factors mentioned in this press release, such risks and uncertainties include, but are not limited to, the Company’s ability to sustain and increase its profitability; the Company’s ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Company’s corporate strategy; the Company’s future financial performance and projected revenue and expenditures; the Company’s ability to increase the number of prescriptions written for each of its products; the Company’s ability to increase its revenues; the Company’s ability to commercialize its products including Qelbree; the Company’s ability to enter into future collaborations with pharmaceutical companies and academic institutions or to obtain funding from government agencies; the Company’s product research and development activities, including the timing and progress of the Company’s clinical trials; the Company’s ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company’s product candidates including SPN-830 and SPN-812 for adult ADHD patients; the Company’s ability to protect its intellectual property and operate its business without infringing upon the intellectual property rights of others; the Company’s expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Company’s product candidates; the accuracy of the Company’s estimates of the size and characteristics of the markets that may be addressed by its product candidates; the Company’s ability to increase its manufacturing capabilities for its products and product candidates; the Company’s projected markets and growth in markets; the Company’s product formulations and patient needs and potential funding sources; the Company’s staffing needs; and other risk factors set forth from time to time in the Company’s filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. The Company undertakes no obligation to update the information in this press release to reflect events or circumstances after the date hereof or to reflect the occurrence of anticipated or unanticipated events.

    Supernus Pharmaceuticals, Inc.
    Condensed Consolidated Balance Sheets
    (in thousands, except share data)

     March 31,
    2021    		 December 31,
    2020
     (unaudited)  
    Assets   
    Current assets   
    Cash and cash equivalents$255,642  $288,640 
    Marketable securities135,459  133,893 
    Accounts receivable, net127,065  140,877 
    Inventories, net50,226  48,325 
    Prepaid expenses and other current assets17,631  18,682 
    Total current assets586,023  630,417 
    Long term marketable securities416,566  350,359 
    Property and equipment, net37,950  37,824 
    Intangible assets, net358,736  364,342 
    Goodwill77,911  77,911 
    Other assets30,257  43,249 
    Total assets$1,507,443  $1,504,102 
        
    Liabilities and stockholders’ equity   
    Current liabilities   
    Accounts payable and accrued liabilities$70,099  $78,934 
    Accrued product returns and rebates128,736  126,192 
    Contingent consideration, current portion31,520  30,900 
    Other current liabilities10,457  9,082 
    Total current liabilities240,812  245,108 
    Convertible notes, net366,038  361,751 
    Contingent consideration, long term46,200  45,800 
    Operating lease liabilities, long term28,532  28,579 
    Deferred income tax liabilities31,742  35,215 
    Other liabilities39,675  42,791 
    Total liabilities752,999  759,244 
        
    Stockholders’ equity   
    Common stock, $0.001 par value; 130,000,000 shares authorized; 52,994,137 and 52,868,482 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively53  53 
    Additional paid-in capital415,950  409,332 
    Accumulated other comprehensive earnings, net of tax6,249  8,975 
    Retained earnings332,192  326,498 
    Total stockholders’ equity754,444  744,858 
    Total liabilities and stockholders’ equity$1,507,443  $1,504,102 

    Supernus Pharmaceuticals, Inc.
    Condensed Consolidated Statements of Earnings
    (in thousands, except share and per share data)

     Three Months ended 
    March 31,
     2021 2020
     (unaudited)
    Revenues   
    Net product sales$128,381   $92,490  
    Royalty revenues2,551   2,486  
    Total revenues130,932   94,976  
        
    Costs and expenses   
    Cost of goods sold (a)14,954   4,152  
    Research and development34,280   18,937  
    Selling, general and administrative61,457   41,614  
    Amortization of intangible assets6,007   1,261  
    Contingent consideration expense1,020   —  
    Total costs and expenses117,718   65,964  
        
    Operating earnings13,214   29,012  
        
    Other income (expense)   
    Interest expense(6,097)  (5,755) 
    Interest and other income, net3,812   5,777  
    Total other income (expense)(2,285)  22  
        
    Earnings before income taxes10,929   29,034  
        
    Income tax expense5,235   7,516  
    Net earnings$5,694   $21,518  
        
    Earnings per share   
    Basic$0.11   $0.41  
    Diluted$0.11   $0.40  
        
    Weighted-average shares outstanding   
    Basic52,927,467   52,534,787  
    Diluted54,196,971   53,581,051  

    ___________________________________________

    (a) Excludes amortization of acquired intangible assets

    CONTACTS:

    Jack A. Khattar, President and CEO
    Jim Kelly, Executive Vice President and CFO
    Supernus Pharmaceuticals, Inc.
    Tel: (301) 838-2591

    or

    INVESTOR CONTACT:
    Peter Vozzo
    Westwicke/ICR
    Office: (443) 213-0505
    Mobile: (443) 377-4767
    Email: peter.vozzo@westwicke.com


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