SUPN Supernus Pharmaceuticals Inc.

28.31
+0.2  (+1%)
Previous Close 28.11
Open 27.99
52 Week Low 17.2
52 Week High 31.99
Market Cap $1,498,253,159
Shares 52,923,107
Float 35,477,775
Enterprise Value $1,479,460,537
Volume 374,546
Av. Daily Volume 552,983
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
SPN-812 (adult)
ADHD
sNDA Filing
sNDA Filing
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.

Drug Pipeline

Drug Stage Notes
SPN-812 (pediatric)
ADHD
Approved
Approved
FDA approval announced April 2, 2021
SPN-820
Treatment-resistant depression
Phase 2
Phase 2
Phase 2 trial to be initiated 2H 2021.
SPN-830
Motor fluctuations in Parkinson’s disease (PD)
NDA Filing
NDA Filing
Refusal to file letter announced November 9, 2020.
SPN-604
Bipolar depression
Phase 3
Phase 3
Phase 3 development has been terminated - May 5, 2020.
SPN-810 (P302)
Attention Deficit Hyperactivity Disorder (ADHD)
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - February 25, 2020.
SPN-810
Impulsive Aggression in ADHD
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - November 5, 2019.
Oxtellar XR
Epilepsy
Approved
Approved
FDA approval announced December 14, 2018 to expand label to include monotherapy treatment.
Trokendi
Migraine
Approved
Approved
Tentative approval August 19 2016, subject to the pediatric exclusivity which expires March 28, 2017. Final approval announced April 6, 2017.
Trokendi
Epilepsy
Approved
Approved
Approved Aug 19, 2013.
Oxtellar
Epilepsy
Approved
Approved
Approved October 22, 2017.

Latest News

  1. Qelbree (viloxazine extended-release capsules) represents the first novel non-stimulant treatment for ADHD in a decade

    Supernus plans to make Qelbree available in the U.S. in 2Q 2021

    ROCKVILLE, Md., April 02, 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 announced that the U.S. Food and Drug Administration (FDA) approved Qelbree (viloxazine extended-release capsules) for the treatment of attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age.

    "Based on the efficacy demonstrated in the clinical program, we believe Qelbree offers a unique…

    Qelbree (viloxazine extended-release capsules) represents the first novel non-stimulant treatment for ADHD in a decade

    Supernus plans to make Qelbree available in the U.S. in 2Q 2021

    ROCKVILLE, Md., April 02, 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 announced that the U.S. Food and Drug Administration (FDA) approved Qelbree (viloxazine extended-release capsules) for the treatment of attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age.

    "Based on the efficacy demonstrated in the clinical program, we believe Qelbree offers a unique new alternative for the treatment of ADHD," said Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. "Qelbree provides prescribing physicians and patients living with ADHD a therapy that is not a controlled substance with proven efficacy and a tolerable safety profile. We are grateful to the patients, families and their care givers who participated in and supported our research."

    "ADHD is one of the most common mental health issues in the U.S.," said Andrew J. Cutler, M.D., Clinical Associate Professor of Psychiatry at SUNY Upstate Medical University, and Chief Medical Officer, Neuroscience Education Institute. "The right treatment is key for children and adolescents, as they grow and navigate school and social relationships. This approval offers a novel once a day sprinkleable non-stimulant that can be a great option for children and adolescents with ADHD."

    The approval of Qelbree is supported by data from an extensive development program consisting of four Phase III clinical trials that studied more than 1000 pediatric patients from the age of 6 to 17 years. 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 to the FDA for Qelbree in adults in the second half of 2021.

    IMPORTANT SAFETY INFORMATION

    Qelbree may increase suicidal thoughts and actions in some children with ADHD, especially within the first few months of treatment or when the dose is changed. Pay close attention to any new or sudden changes in mood, behavior, thoughts, and feelings. Call your child's doctor right away if there are any new or sudden changes, or if there is development of suicidal thoughts or actions.  Qelbree should not be taken by patients that also take certain anti-depression medicines, especially those called a monoamine oxidase inhibitor or MAOI, or certain asthma medicines.

    Please see full Prescribing Information, including Boxed Warning, for Qelbree. 

    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, attention-deficit hyperactivity disorder (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 expenditures; the Company's ability to increase the number of prescriptions written for each of its products; the Company's ability to increase its net revenue; 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, and projected expenditures; the Company's ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company's product candidates; 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.

    CONTACT:

    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:

     



    Primary Logo

    View Full Article Hide Full Article
  2. ROCKVILLE, Md., Feb. 26, 2021 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that Jack Khattar, President and CEO of Supernus Pharmaceuticals, will participate in a fireside chat at the Cowen 41st Annual Health Care Conference on Wednesday, March 3, 2021, at 12:20 p.m. ET.

    A live webcast of the presentation can be accessed by visiting Events & Presentations in the Investor Relations section on the Company's website at www.supernus.com. An archived replay will be available for 60 days on the Company's website following the conference.

    About Supernus Pharmaceuticals

    Supernus…

    ROCKVILLE, Md., Feb. 26, 2021 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that Jack Khattar, President and CEO of Supernus Pharmaceuticals, will participate in a fireside chat at the Cowen 41st Annual Health Care Conference on Wednesday, March 3, 2021, at 12:20 p.m. ET.

    A live webcast of the presentation can be accessed by visiting Events & Presentations in the Investor Relations section on the Company's website at www.supernus.com. An archived replay will be available for 60 days on the Company's website following the conference.

    About Supernus Pharmaceuticals

    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, 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 attention-deficit hyperactivity disorder (ADHD), hypomobility in Parkinson's disease, epilepsy, depression, and rare CNS disorders.

    For more information, please visit www.supernus.com.

    CONTACTS:

    Jack A. Khattar, President and CEO

    Jim Kelly, EVP & Chief Financial Officer

    Supernus Pharmaceuticals, Inc.

    Tel: (301) 838-2591

    or

    INVESTOR CONTACT:

    Peter Vozzo

    Westwicke/ICR

    Office: (443) 213-0505

    Mobile: (443) 377-4767

    Email:



    Primary Logo

    View Full Article Hide Full Article
    • Full year 2020 total revenues of $520.4 million, a 32% increase compared to 2019
    • Full year 2020 operating earnings of $173.7 million, a 17% increase compared to 2019
    • SPN-812 NDA assigned an early April 2021 PDUFA date
    • Positive results from Phase III study for SPN-812 in adults with ADHD announced in December 2020
    • Full year 2021 total revenues guidance of $550 million to $580 million

    ROCKVILLE, Md., Feb. 25, 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 fourth quarter and full year of 2020, and associated Company developments.

    "We reported record…

    • Full year 2020 total revenues of $520.4 million, a 32% increase compared to 2019
    • Full year 2020 operating earnings of $173.7 million, a 17% increase compared to 2019
    • SPN-812 NDA assigned an early April 2021 PDUFA date
    • Positive results from Phase III study for SPN-812 in adults with ADHD announced in December 2020
    • Full year 2021 total revenues guidance of $550 million to $580 million

    ROCKVILLE, Md., Feb. 25, 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 fourth quarter and full year of 2020, and associated Company developments.

    "We reported record revenues and operating earnings in 2020 based on the growth of Trokendi XR and Oxtellar XR and the addition of the CNS products acquired during the year," said Jack Khattar, President and CEO of Supernus Pharmaceuticals. "Looking ahead, we are preparing for the expected launch of SPN-812 in the second quarter of 2021 and are excited to bring a novel non-stimulant treatment option to the millions of children and adolescents across the U.S. with ADHD."

    Commercial Update

    Fourth quarter 2020 net product sales were $140.7 million, 44% higher than the same period in 2019, driven by the addition of $39.5 million of net product sales from the commercial products acquired in 2020 and $3.3 million in net product sales growth from Trokendi XR and Oxtellar XR. Full year 2020 net product sales were $509.3 million, 33% higher than full year 2019, driven by the addition of $91.0 million of net product sales from the commercial products acquired in 2020 and $34.9 million in net product sales growth from Trokendi XR and Oxtellar XR.

    Net Product Sales             
    ($ in millions)Q4 2020 Q4 2019 Change %

     FY 2020 FY 2019 Change %

    Trokendi XR$78.5  $75.2  4% $319.6  $295.2  8%
    Oxtellar XR22.7  22.7  % 98.7  88.2  12%
    APOKYN31.2    **  74.3    ** 
    MYOBLOC4.5    **  9.8    ** 
    XADAGO3.8    **  6.9    ** 
    Net Product Sales$140.7  $97.9  44% $509.3  $383.4  33%

    Product Pipeline Update

    SPN-812 - Novel non-stimulant for the treatment of ADHD in children and adults

    • In February 2021, the Company received notice from the U.S. Food and Drug Administration (FDA) that its New Drug Application (NDA) resubmission for SPN-812 for the treatment of ADHD in pediatric patients is considered a Class I resubmission, thereby assigning a timeline of two months for review by the FDA and establishing a new Prescription Drug User Fee Act (PDUFA) target action date in early April 2021. The Company is preparing for the commercial launch of SPN-812 for the treatment of ADHD in pediatric patients in the second quarter of 2021, if approved by the FDA.
    • In December 2020, the Company announced positive results from a Phase III trial in adult patients with ADHD. Assuming approval for pediatric patients, the Company plans to submit a supplemental NDA (sNDA) to the FDA for SPN-812 in adults in the second half of 2021.

    SPN-830 (Apomorphine infusion pump) - Continuous treatment of motor fluctuations ("on-off" episodes) in PD

    • The Company is scheduled to meet with the FDA in March 2021 in a Type A meeting to discuss the contents of the Refusal to File (RTF) letter it received in November 2020 regarding its NDA for SPN-830. In the letter, the FDA requested certain documents and reports to be submitted in support of the application. The Company believes additional testing of the device will be necessary to support the SPN-830 NDA resubmission. Supernus plans to resubmit the SPN-830 NDA after completing discussions with the FDA and the required activities for filing.

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

    • Development activities are ongoing, including a multiple-ascending dose study in healthy volunteers, with the goal of initiating a Phase II clinical program in treatment-resistant depression by the end of 2021.

    Financial Highlights

    Fourth quarter and full year 2020 operating earnings were $43.0 million and $173.7 million respectively, as compared to $40.8 million and $148.6 million in the fourth quarter 2019.

    Fourth quarter 2020 net earnings and diluted earnings per share were $30.8 million and $0.57, respectively, as compared to $33.1 million, or $0.62 per diluted share, in the same period last year.

    2020 full year net earnings and diluted earnings per share were $127.0 million and $2.36 per diluted share, respectively, as compared to $113.1 million and $2.10 per diluted share, for full year 2019.

    As of December 31, 2020, the Company had $772.9 million in cash, cash equivalents and marketable securities, compared to $938.8 million as of December 31, 2019. During 2020, the Company made cash payments of approximately $300 million related to the acquisition of the CNS portfolio of US WorldMeds and $25 million to Navitor upon executing the development and option agreement for SPN-820.

    Full Year 2021 Financial Guidance

    The Company expects to achieve the following financial objectives in 2021:

     Full Year 2021 Guidance
     ($ in millions)
    Total revenues (1)$550 - $580
    Combined R&D and SG&A expenses (2)$380 - $410
    Operating earnings (3)$65 - $90
    Amortization of intangible assets$24

    ___________________________________________

    1) Total revenues include net product sales and royalty revenue. Include $10 million for SPN-812 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.



    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, on Thursday, February 25, 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:2253809
    Conference Call Name:Supernus Pharmaceuticals Fourth Quarter and Full Year 2020 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, Inc. 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, 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 attention-deficit hyperactivity disorder (ADHD), 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. These forward-looking statements include expectations regarding the Company's recent and future interactions and communications with the FDA concerning the NDAs for SPN-812 and SPN-830, any additional FDA requirements to support the SPN-830 NDA resubmissions, the potential approval of the NDAs for SPN-812 and SPN-830, the planned submission of an sNDA to the FDA for SPN-812 in adults and the potential benefits and commercialization of SPN-812 and SPN-830. 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 expenditures; the Company's product research and development activities, including the timing and progress of the Company's clinical trials, and projected expenditures; the Company's ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company's product candidates; 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 products and 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; 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)

     December 31, 2020 December 31, 2019
     (unaudited)  
    Assets   
    Current assets   
    Cash and cash equivalents$288,640  $181,381 
    Marketable securities133,893  165,692 
    Accounts receivable, net140,877  87,332 
    Inventories, net48,325  26,628 
    Prepaid expenses and other current assets18,682  11,611 
    Total current assets630,417  472,644 
    Long term marketable securities350,359  591,773 
    Property and equipment, net37,824  17,068 
    Goodwill and intangible assets, net442,253  24,840 
    Deferred income taxes  32,063 
    Other assets43,249  21,894 
    Total assets$1,504,102  $1,160,282 
        
    Liabilities and stockholders' equity   
    Current liabilities   
    Accounts payable and accrued liabilities$78,934  $49,714 
    Accrued product returns and rebates126,192  107,629 
    Contingent consideration, current portion30,900   
    Other current liabilities9,082  3,244 
    Total current liabilities245,108  160,587 
    Convertible notes, net361,751  345,170 
    Contingent consideration, long term45,800   
    Operating lease liabilities, long term28,579  30,440 
    Deferred income tax liabilities35,215   
    Other liabilities42,791  28,657 
    Total liabilities759,244  564,854 
        
    Stockholders' equity   
    Common stock, $0.001 par value; 130,000,000 shares authorized; 52,868,482 and 52,533,348 shares issued and outstanding as of December 31, 2020 and December 31, 2019, respectively53  53 
    Additional paid-in capital409,332  388,410 
    Accumulated other comprehensive earnings, net of tax8,975  7,417 
    Retained earnings326,498  199,548 
    Total stockholders' equity744,858  595,428 
    Total liabilities and stockholders' equity$1,504,102  $1,160,282 



    Supernus Pharmaceuticals, Inc.


    Condensed Consolidated Statements of Earnings

    (in thousands, except share and per share data)

     Three Months Ended December 31, Years Ended December 31,
     2020 2019 2020 2019
            
     (unaudited) (unaudited)
    Revenues       
    Net product sales$140,743  $97,909  $509,350  $383,400 
    Royalty revenue2,814  2,537  11,047  9,355 
    Total revenues143,557  100,446  520,397  392,755 
            
    Costs and expenses       
    Cost of goods sold (a)18,533  4,113  52,459  16,660 
    Research and development17,938  19,792  75,961  69,099 
    Selling, general and administrative56,500  34,464  200,677  153,246 
    Amortization of intangible assets5,888  1,261  15,702  5,179 
    Contingent consideration expense1,700    1,900   
    Total costs and expenses100,559  59,630  346,699  244,184 
            
    Operating earnings42,998  40,816  173,698  148,571 
            
    Other income (expense)       
    Interest expense(6,096) (5,870) (23,754) (22,707)
    Interest and other income, net2,791  5,966  18,704  21,623 
    Total other expense(3,305) 96  (5,050) (1,084)
            
    Earnings before income taxes39,693  40,912  168,648  147,487 
            
    Income tax expense8,925  7,783  41,698  34,431 
    Net earnings$30,768  $33,129  $126,950  $113,056 
            
    Earnings per share       
    Basic$0.58  $0.63  $2.41  $2.16 
    Diluted$0.57  $0.62  $2.36  $2.10 
            
    Weighted-average shares outstanding       
    Basic52,708,643  52,471,389  52,615,269  52,412,181 
    Diluted53,747,118  53,649,083  53,689,743  53,816,754 

    ___________________________________________

    (a) Excludes amortization of acquired intangible assets



    CONTACTS:

    Jack A. Khattar, President and Chief Executive Officer

    Jim Kelly, EVP & Chief Financial Officer

    Supernus Pharmaceuticals, Inc.

    Tel: (301) 838-2591

    or

    INVESTOR CONTACT:

    Peter Vozzo

    Westwicke, an ICR Company

    Office: (443) 213-0505

    Mobile: (443) 377-4767

    Email:



    Primary Logo

    View Full Article Hide Full Article
  3. ROCKVILLE, Md., Feb. 23, 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 announced that the Company expects to report business results for the fourth quarter and full year 2020 after the market closes on Thursday, February 25, 2021.

    Jack Khattar, President and CEO, and Jim Kelly, Executive Vice President and Chief Financial Officer, will host a conference call to present the fourth quarter and full year 2020 business and financial results on Thursday, February 25, 2021 at 4:30 p.m. ET. Following management's prepared remarks and discussion of business results, the call will…

    ROCKVILLE, Md., Feb. 23, 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 announced that the Company expects to report business results for the fourth quarter and full year 2020 after the market closes on Thursday, February 25, 2021.

    Jack Khattar, President and CEO, and Jim Kelly, Executive Vice President and Chief Financial Officer, will host a conference call to present the fourth quarter and full year 2020 business and financial results on Thursday, February 25, 2021 at 4:30 p.m. ET. Following management's prepared remarks and discussion of business results, the call will be open for questions.

    A live webcast will be available at www.supernus.com.

    Please refer to the information below for conference call dial-in information. 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:2253809
    Conference Call Name:Supernus Pharmaceuticals Fourth Quarter and Full Year 2020 Results Conference Call

    Following the live call, a replay will be available on the Company's website, www.supernus.com, in the Investor Relations section. The webcast will be available on the Company's website for 60 days following the live call.

    About Supernus Pharmaceuticals, Inc.

    Supernus Pharmaceuticals, Inc. 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, 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 attention-deficit hyperactivity disorder (ADHD), hypomobility in Parkinson's disease, epilepsy, depression, and rare CNS disorders. For more information, please visit www.supernus.com.

    CONTACTS:

    Jack A. Khattar, President and Chief Executive Officer

    Jim Kelly, EVP & Chief Financial Officer

    Supernus Pharmaceuticals, Inc.

    Tel: (301) 838-2591

    or

    INVESTOR CONTACT:

    Peter Vozzo

    Westwicke, an ICR Company

    Office: (443) 213-0505

    Mobile: (443) 377-4767

    Email:



    Primary Logo

    View Full Article Hide Full Article
  4. ROCKVILLE, Md., Feb. 22, 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 announced that it received notice from the U.S. Food and Drug Administration (FDA) that the company's New Drug Application (NDA) resubmission for SPN-812 for the treatment of ADHD in pediatric patients is considered a Class I resubmission thereby assigning a timeline of two months for review by the FDA and establishing a new Prescription Drug User Fee Act (PDUFA) target action date in early April 2021.

    Supernus will continue to work closely with the FDA as it completes its review of the SPN-812 NDA. If…

    ROCKVILLE, Md., Feb. 22, 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 announced that it received notice from the U.S. Food and Drug Administration (FDA) that the company's New Drug Application (NDA) resubmission for SPN-812 for the treatment of ADHD in pediatric patients is considered a Class I resubmission thereby assigning a timeline of two months for review by the FDA and establishing a new Prescription Drug User Fee Act (PDUFA) target action date in early April 2021.

    Supernus will continue to work closely with the FDA as it completes its review of the SPN-812 NDA. If approved by the FDA, the Company is preparing for the commercial launch of SPN-812 for the treatment of ADHD in pediatric patients in the second quarter of 2021.

    In December 2020, Supernus announced positive results from a Phase III study for SPN-812 in adults with ADHD. The Company plans to submit a supplemental NDA (sNDA) to the FDA for SPN-812 for the treatment of ADHD in adult patients in the second half of 2021, assuming approval for pediatric patients.

    About Supernus Pharmaceuticals, Inc.

    Supernus Pharmaceuticals, Inc. 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, 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 attention-deficit hyperactivity disorder (ADHD), 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. These forward-looking statements include expectations regarding the Company's recent and future interactions and communications with the FDA, the potential approval of the NDA for SPN-812 for the treatment of ADHD in pediatric patients, the planned submission of a sNDA to the FDA for SPN-812 for the treatment of ADHD in adult patients and the potential benefits and commercialization of SPN-812. 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 expenditures; the Company's product research and development activities, including the timing and progress of the Company's clinical trials, and projected expenditures; the Company's ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company's product candidates; 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 products and 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; 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.

    CONTACTS:

    Jack A. Khattar, President and Chief Executive Officer

    Jim Kelly, EVP & Chief Financial Officer

    Supernus Pharmaceuticals, Inc.

    Tel: (301) 838-2591

    or

    INVESTOR CONTACT:

    Peter Vozzo

    Westwicke/ICR

    Office: (443) 213-0505

    Mobile: (443) 377-4767

    Email:



    Primary Logo

    View Full Article Hide Full Article
View All Supernus Pharmaceuticals Inc. News