SUPN Supernus Pharmaceuticals Inc.

23.61
-0.36  -2%
Previous Close 23.97
Open 24.21
52 Week Low 13.12
52 Week High 34.11
Market Cap $1,240,437,739
Shares 52,538,659
Float 51,545,569
Enterprise Value $1,241,972,656
Volume 348,731
Av. Daily Volume 533,881
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Upcoming Catalysts

Drug Stage Catalyst Date
SPN-812 (P301)
ADHD
PDUFA
PDUFA
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SPN-812 (adult)
ADHD
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
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. ROCKVILLE, Md., June 26, 2020 (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, announced that earlier today it sued generic drug maker Apotex Inc. and Apotex Corp. (collectively, Apotex) for infringement of nine patents covering its antiepileptic drug Oxtellar XR®. Supernus's United States Patent Nos. 7,722,898, 7,910,131, 8,617,600, 8,821,930, 9,119,791, 9,351,975, 9,370,525, 9,855,278, and 10,220,042 cover once-a-day oxcarbazepine formulations and methods of treating seizures using those formulations. These nine patents do not expire until April 13, 2027.

    The Complaint – filed in the U.S…

    ROCKVILLE, Md., June 26, 2020 (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, announced that earlier today it sued generic drug maker Apotex Inc. and Apotex Corp. (collectively, Apotex) for infringement of nine patents covering its antiepileptic drug Oxtellar XR®. Supernus's United States Patent Nos. 7,722,898, 7,910,131, 8,617,600, 8,821,930, 9,119,791, 9,351,975, 9,370,525, 9,855,278, and 10,220,042 cover once-a-day oxcarbazepine formulations and methods of treating seizures using those formulations. These nine patents do not expire until April 13, 2027.

    The Complaint – filed in the U.S. District Court for the District of New Jersey – alleges that Apotex infringed Supernus's Oxtellar XR patents by submitting to the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) seeking to market a generic version of Oxtellar XR prior to the expiration of Supernus's patents. Filing its Complaint within 45 days of receiving Apotex's Paragraph IV certification notice entitles Supernus to an automatic stay preventing the FDA from approving Apotex's ANDA for 30 months.

    Supernus has previously defended the Oxtellar XR intellectual property rights separately against two earlier generic filers; namely, Actavis and TWi Pharmaceuticals and related entities. In both cases, Supernus prevailed before the District Court as well as on appeal. Oxtellar XR is currently protected by nine patents listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) that expire on April 13, 2027.

    About Supernus Pharmaceuticals, Inc.

    Supernus Pharmaceuticals, Inc. is a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. The Company markets Trokendi XR® (extended-release topiramate) for the prophylaxis of migraine and the treatment of epilepsy, Oxtellar XR® (extended-release oxcarbazepine) for the treatment of epilepsy, Apokyn® (apomorphine hydrochloride injection) for the acute treatment of hypomobility in advanced Parkinson's disease (PD), Myobloc® (rimabotulinumtoxinB) for the treatment of cervical dystonia and treatment of chronic sialorrhea in adults, and Xadago® (safinamide) as an adjunctive treatment to levodopa/carbidopa in PD patients with hypomobility. The Company is also developing several product candidates to address large market opportunities in the CNS market, including SPN-812 for the treatment of ADHD, apomorphine infusion pump for hypomobility in PD, SPN-820 (NV-5138) for treatment-resistant depression, and SPN-817 for the treatment of epilepsy.

    APOKYN Pen and apomorphine infusion pump product candidate are under a license from Britannia Pharmaceuticals Limited

    XADAGO is under a license from Zambon S.p.A

    All trademarks are the property of their respective owners

    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 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.

    CONTACTS:

    Jack A. Khattar, President and CEO

    Gregory S. Patrick, Senior Vice President and CFO

    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

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  2. ROCKVILLE, Md., June 09, 2020 (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 the closing of the acquisition of the CNS portfolio of US WorldMeds, a privately-held biopharmaceutical company. This transaction builds on Supernus' experience in CNS diseases and expands its marketing and development efforts into Parkinson's disease.

    "This acquisition significantly expands our business in CNS and increases and diversifies our revenue and earnings streams, while continuing to maintain a strong balance sheet," said Jack Khattar, President and CEO of Supernus. "We welcome our US…

    ROCKVILLE, Md., June 09, 2020 (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 the closing of the acquisition of the CNS portfolio of US WorldMeds, a privately-held biopharmaceutical company. This transaction builds on Supernus' experience in CNS diseases and expands its marketing and development efforts into Parkinson's disease.

    "This acquisition significantly expands our business in CNS and increases and diversifies our revenue and earnings streams, while continuing to maintain a strong balance sheet," said Jack Khattar, President and CEO of Supernus. "We welcome our US WorldMeds' colleagues who are joining Supernus and look forward to working with them on building our leadership position in CNS across numerous diseases."

    For additional details relating to the acquisition, please see the press release HERE issued by Supernus on April 28, 2020 announcing the acquisition.

    About Supernus Pharmaceuticals, Inc.

    Supernus Pharmaceuticals, Inc. is a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. The Company markets Trokendi XR® (extended-release topiramate) for the prophylaxis of migraine and the treatment of epilepsy, Oxtellar XR® (extended-release oxcarbazepine) for the treatment of epilepsy, Apokyn® (apomorphine hydrochloride injection) for the acute treatment of hypomobility in advanced Parkinson's disease (PD), Myobloc® (rimabotulinumtoxinB) for the treatment of cervical dystonia and treatment of chronic sialorrhea in adults, and Xadago® (safinamide) as an adjunctive treatment to levodopa/carbidopa in PD patients with hypomobility. The Company is also developing several product candidates to address large market opportunities in the CNS market, including SPN-812 for the treatment of ADHD, apomorphine infusion pump for hypomobility in PD, SPN-820 (NV-5138) for treatment-resistant depression, and SPN-817 for the treatment of epilepsy.

    APOKYN Pen and apomorphine infusion pump product candidate are under a license from Britannia Pharmaceuticals Limited

    XADAGO is under a license from Zambon S.p.A

    All trademarks are the property of their respective owners

    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 successfully incorporate and integrate the acquired products and product candidate, technologies, sales force and organization into its current infrastructure, the Company's ability to achieve the anticipated revenues and benefits from the acquired products; 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 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.

    CONTACTS:

    Jack A. Khattar, President and CEO

    Gregory S. Patrick, Senior Vice President and CFO

    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

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  3. ROCKVILLE, Md., May 27, 2020 (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 the Company's management will present an overview and update, as well as host investor meetings, at the Jefferies Virtual Healthcare Conference on Tuesday, June 2, 2020 at 4:00 p.m. ET. 

    Investors interested in arranging a virtual meeting with the Company's management during this conference should contact the conference coordinator.

    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

    ROCKVILLE, Md., May 27, 2020 (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 the Company's management will present an overview and update, as well as host investor meetings, at the Jefferies Virtual Healthcare Conference on Tuesday, June 2, 2020 at 4:00 p.m. ET. 

    Investors interested in arranging a virtual meeting with the Company's management during this conference should contact the conference coordinator.

    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 of this webcast will be available for 60 days on the Company's website after the conference.

    About Supernus Pharmaceuticals, Inc.

    Supernus Pharmaceuticals, Inc. is a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. The Company currently markets Trokendi XR® (extended-release topiramate) for the prophylaxis of migraine and the treatment of epilepsy, and Oxtellar XR® (extended-release oxcarbazepine) for the treatment of epilepsy. The Company is also developing several product candidates to address large market opportunities in the CNS market, including SPN-812 for the treatment of ADHD, SPN-820 (NV-5138) for treatment-resistant depression, and SPN-817 for the treatment of epilepsy.

    CONTACTS:
    Jack A. Khattar, President and CEO

    Gregory S. Patrick, Senior Vice President and CFO

    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

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  4. ROCKVILLE, Md., May 15, 2020 (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 on May 14, 2020 the Company received a Paragraph IV Notice Letter from Apotex Inc.  and Apotex Corp advising Supernus of the submission by Apotex of an Abbreviated New Drug Application to the U.S. Food and Drug Administration (FDA) seeking approval for oxcarbazepine extended-release tablets. Supernus is currently reviewing the details of this Notice Letter and intends to vigorously enforce its intellectual property rights (IPR) relating to Oxtellar XR.

    Supernus has previously defended the Oxtellar…

    ROCKVILLE, Md., May 15, 2020 (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 on May 14, 2020 the Company received a Paragraph IV Notice Letter from Apotex Inc.  and Apotex Corp advising Supernus of the submission by Apotex of an Abbreviated New Drug Application to the U.S. Food and Drug Administration (FDA) seeking approval for oxcarbazepine extended-release tablets. Supernus is currently reviewing the details of this Notice Letter and intends to vigorously enforce its intellectual property rights (IPR) relating to Oxtellar XR.

    Supernus has previously defended the Oxtellar XR IPR against two earlier generic filers; namely, Actavis and Twi Pharmaceuticals and related entities.  In both cases, Supernus prevailed before the district court as well as on appeal.   Oxtellar XR is currently protected by nine patents listed in the FDA's Approved Drugs Product List (Orange Book) that expire no earlier than 2027. 

    About Supernus Pharmaceuticals, Inc.

    Supernus Pharmaceuticals, Inc. is a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. The Company currently markets Trokendi XR® (extended-release topiramate) for the prophylaxis of migraine and the treatment of epilepsy, and Oxtellar XR® (extended-release oxcarbazepine) for the treatment of epilepsy. The Company is also developing several product candidates to address large market opportunities in the CNS market, including SPN-812 for the treatment of ADHD, SPN-820 (NV-5138) for treatment-resistant depression, and SPN-817 for the treatment of epilepsy.

    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 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.

    CONTACTS:
    Jack A. Khattar, President and CEO

    Gregory S. Patrick, Senior Vice President and CFO

    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

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    • First quarter total revenue of $95.0 million, an 11% increase over 2019
    • First quarter net product sales of $92.5 million, an 11% increase over 2019
    • First quarter operating earnings of $29.0 million, a 14% increase over 2019
    • On track for launch of SPN-812 at the end of 2020, pending FDA approval. PDUFA date of November 8, 2020 for review of NDA
    • Acquisition of CNS portfolio of US WorldMeds expands and strengthens neurology portfolio with established marketed products and late-stage pipeline. Expected to close in second quarter 2020
    • Partnership with Navitor Pharmaceuticals expands psychiatry portfolio with Phase II program for potential treatment of depression

    ROCKVILLE, Md., May 05, 2020 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (NASDAQ…

    • First quarter total revenue of $95.0 million, an 11% increase over 2019
    • First quarter net product sales of $92.5 million, an 11% increase over 2019
    • First quarter operating earnings of $29.0 million, a 14% increase over 2019
    • On track for launch of SPN-812 at the end of 2020, pending FDA approval. PDUFA date of November 8, 2020 for review of NDA
    • Acquisition of CNS portfolio of US WorldMeds expands and strengthens neurology portfolio with established marketed products and late-stage pipeline. Expected to close in second quarter 2020
    • Partnership with Navitor Pharmaceuticals expands psychiatry portfolio with Phase II program for potential treatment of depression

    ROCKVILLE, Md., May 05, 2020 (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 reported financial results for the first quarter of 2020 and associated Company developments

    Commercial Update

    First quarter 2020 product prescriptions for Trokendi XR® and Oxtellar XR®, as reported by IQVIA, totaled 203,404, a 2% increase over first quarter 2019.

      Prescriptions    
      Q1 2020   Q1 2019   Change %
    Trokendi XR 160,315     160,940     %
    Oxtellar XR 43,089     38,580     12 %
    Total 203,404     199,520     2 %

    Source: IQVIA

    First quarter 2020 net product sales were $92.5 million, an increase of 11% over $83.1 million in the first quarter of 2019. As previously disclosed, wholesalers, distributors, and pharmacies decreased their inventory levels of the Company's products in the first quarter of 2019. The Company estimates that this caused net product sales in the first quarter of 2019 to be approximately $10 million lower had inventory levels remained constant, thus favorably impacting year over year net product sales growth in the first quarter of 2020.

      Net Product Sales
    ($ in millions)

       
      Q1 2020   Q1 2019   Change %
    Trokendi XR $ 68.6     $ 63.7     8 %
    Oxtellar XR 23.9     19.4     23 %
    Total $ 92.5     $ 83.1     11 %

    Supply of Trokendi XR and Oxtellar XR has not been impacted by COVID-19. The Company has adequate inventory on hand for both products to continue to be available to patients.

    Corporate and Product Pipeline Update

    SPN-812 - Novel non-stimulant for the treatment of ADHD

    • The Company continues to prepare for the commercial launch of SPN-812 at the end of 2020.
    • The Company remains engaged with the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for SPN-812 for the treatment of ADHD, which has a Prescription Drug User Fee Act (PDUFA) target action date of November 8, 2020.
    • The Phase III program in adult patients reached approximately 75% of the targeted enrollment before additional enrollment was put on hold in March 2020 due to the impact of COVID-19. The Company is employing virtual efforts to ensure that currently enrolled subjects can progress to completion of treatment. This trial was ahead of schedule prior to the COVID-19 pandemic, with a potential data release in the second half of this year. Depending on when the Company can restart enrollment and complete the study, data from the trial may be pushed into 2021.

    CNS portfolio of US WorldMeds

    • As announced last week, Supernus entered into a definitive Sale and Purchase Agreement to acquire the CNS portfolio of US WorldMeds, a privately-held biopharmaceutical company. The acquisition is expected to close in the second quarter of 2020, subject to certain conditions, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions.
    • US WorldMeds' CNS portfolio consists of three marketed products with 2019 net sales and operating earnings of approximately $150 million and $45 million, respectively, and a product candidate with an expected NDA submission in the second half of 2020.
    • The acquisition expands and strengthens the Company's neurology portfolio, diversifies its revenue and operating cash flow base and enhances long term growth.
    • Total consideration consists of an upfront cash payment of $300 million plus regulatory and commercial milestone cash payments up to $230 million. All cash consideration will be funded through existing balance sheet cash.

    SPN-820 (NV-5138) – novel first-in-class activator of mTORC1

    • Supernus and Navitor Pharmaceuticals, Inc., a privately-held company, announced a joint Development and Option Agreement for Navitor's mTORC1 activator, NV-5138.
    • Supernus and Navitor will jointly conduct a Phase II clinical program for NV-5138 in treatment-resistant depression. Supernus will pay up to $50 million of the costs of Phase II development, plus certain costs associated with nonclinical development and formulation.
    • In addition, Navitor has granted Supernus an exclusive, worldwide (excluding Greater China) option to license or acquire NV-5138 prior to initiation of a Phase III clinical program. In exchange for the option to license or acquire NV-5138, Navitor will receive an upfront payment of $25 million, composed of a $10 million option fee and a $15 million equity investment. The equity investment represents an approximately 13% ownership in Navitor. Total payments, exclusive of royalty payments on net sales of NV-5138 and development costs under the agreement, have the potential to reach $410 million to $475 million, which includes the upfront payment, an additional license or acquisition fee depending on whether Supernus ultimately licenses or acquires NV-5138, and subsequent clinical, regulatory and sales milestone payments.
    • Supernus also will have the first right of refusal for any compound with a similar mechanism of action on mTORC1 as NV-5138 in the central nervous system.

    SPN-604 - Novel treatment of bipolar disorder

    • The Company has reprioritized its research and development (R&D) resources following recent expansion of the product pipeline through mid to late-stage development product candidates. These product candidates include SPN-820 from the Navitor partnership and Apomorphine Infusion Pump from the US WorldMeds transaction. As a result, and given other factors including the estimated timing of a potential launch of SPN-604 and the required investment, the Company is terminating development of SPN-604 for the treatment of bipolar disorder.

    Sales and marketing infrastructure

    • The acquisition of the CNS product portfolio from US WorldMeds includes a sales force of approximately 46 sales representatives that focuses on serving movement disorder specialists in the U.S.
    • The Company continues to plan on adding salesforce personnel toward the end of 2020 in anticipation of the launch of SPN-812. 

    "The two business development transactions that we announced over the last couple of weeks strengthen our product portfolio and late-stage pipeline, diversify our revenue base, enhance our long term growth, and strengthen our leadership position in CNS," said Jack Khattar, President and CEO of Supernus. "In addition, they expand our commercial and R&D platforms into the biologics, orphan disease and specialty pharmacy areas."

    Operating Expenses

    R&D expenses in the first quarter of 2020 were $18.9 million, compared to $15.4 million in the same quarter last year. This increase was primarily driven by enrollment in the SPN-812 Phase III program for adults, initiated in late 2019.

    SG&A expenses in the first quarter of 2020 were $42.9 million, compared to $41.0 million in the same quarter last year. This increase was primarily driven by pre-launch activities associated with SPN-812, partially offset by a decrease in marketing expenses for commercial products and a decrease in employee-related expenses.

    Operating Earnings and Earnings Per Share

    Operating earnings in the first quarter of 2020 were $29.0 million, compared to $25.4 million in the first quarter of 2019. The increase of $3.6 million was primarily due to increased revenue from our two commercial products.

    Net earnings (GAAP) in the first quarter of 2020 were $21.5 million, or $0.40 per diluted share, an increase of 18% on a diluted share amount, as compared to $18.3 million, or $0.34 per diluted share, in the same period last year.

    Weighted-average diluted common shares outstanding were approximately 53.6 million for the first quarter of 2020, as compared to approximately 54.0 million for the prior year period.

    Balance Sheet Highlights

    As of March 31, 2020, the Company had $935.6 million in cash, cash equivalents, marketable securities and long term marketable securities, compared to $938.8 million at December 31, 2019. This decrease was primarily attributable to unrealized losses on long term marketable securities resultant from market volatility in the first quarter of 2020.

    Financial Guidance

    Given the uncertainty caused by the COVID-19 pandemic, the anticipated second quarter acquisition of the CNS portfolio from US WorldMeds and the impact of the partnership with Navitor Pharmaceuticals, the Company is suspending its previously issued full year 2020 financial guidance. The Company expects to update and reinstate full year 2020 guidance no later than the announcement of second quarter 2020 financial results in August.

    Conference Call Details

    The Company will hold a conference call hosted by Jack Khattar, President and Chief Executive Officer, and Greg Patrick, Senior Vice President and Chief Financial Officer, to discuss these results at 9:00 a.m. Eastern Time, on Wednesday, May 6, 2020.

    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: 9899405
    Conference Call Name: Supernus Pharmaceuticals First Quarter 2020 Earnings 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 pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. The Company currently markets Trokendi XR® (extended-release topiramate) for the prophylaxis of migraine and the treatment of epilepsy, and Oxtellar XR® (extended-release oxcarbazepine) for the treatment of epilepsy. The Company is also developing several product candidates to address large market opportunities in the CNS market, including SPN-812 for the treatment of ADHD, SPN-820 (NV-5138) for treatment-resistant depression and SPN-817 for the treatment of epilepsy.

    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 potential impact of COVID-19, 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 successfully incorporate and integrate acquired products and product candidates, technologies, sales force and medical organizations into its current infrastructure; the Company's ability to increase its net revenue; 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.

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

      March 31,   December 31,
      2020   2019
      (unaudited)    
    Assets      
    Current assets      
    Cash and cash equivalents $ 225,767       $ 181,381  
    Marketable securities 175,104       165,692  
    Accounts receivable, net 119,195       87,332  
    Inventories, net 24,418       26,628  
    Prepaid expenses and other current assets 12,564       11,611  
    Total current assets 557,048       472,644  
    Long term marketable securities 534,712       591,773  
    Property and equipment, net 18,011       17,068  
    Intangible assets, net 23,579       24,840  
    Lease assets 21,911       21,279  
    Deferred income taxes 34,067       32,063  
    Other assets 538       615  
           
    Total assets $ 1,189,866       $ 1,160,282  
           
    Liabilities and stockholders' equity      
    Current liabilities      
    Accounts payable $ 3,124       $ 10,141  
    Accrued product returns and rebates 119,453       107,629  
    Accrued expenses and other current liabilities 33,003       37,130  
    Income taxes payable 9,097       2,443  
    Nonrecourse liability related to sale of future royalties, current portion 3,658       3,244  
    Total current liabilities 168,335       160,587  
    Convertible notes, net 349,232       345,170  
    Nonrecourse liability related to sale of future royalties, long term 18,369       19,248  
    Lease liabilities, long term 30,804       30,440  
    Other liabilities 9,743       9,409  
    Total liabilities 576,483       564,854  
           
    Stockholders' equity      
    Common stock, $0.001 par value; 130,000,000 shares authorized; 52,537,159 and 52,533,348 shares issued and outstanding as of March 31, 2020 and December 31, 2019, respectively 53       53  
    Additional paid-in capital 392,430       388,410  
    Accumulated other comprehensive earnings (loss), net of tax (166 )     7,417  
    Retained earnings 221,066       199,548  
    Total stockholders' equity 613,383       595,428  
           
    Total liabilities and stockholders' equity $ 1,189,866       $ 1,160,282  


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

      Three Months ended March 31,
      2020   2019
      (unaudited)
    Revenues      
    Net product sales $ 92,490       $ 83,099    
    Royalty revenues 2,486       2,375    
    Total revenues 94,976       85,474    
           
    Costs and expenses      
    Cost of goods sold 4,152       3,684    
    Research and development 18,937       15,394    
    Selling, general and administrative 42,875       40,968    
           
    Total costs and expenses 65,964       60,046    
           
    Operating earnings 29,012       25,428    
           
    Other income (expense)      
    Interest expense (5,755 )     (5,870 )  
    Interest income, net 5,777       4,681    
    Total other income (expense) 22       (1,189 )  
           
    Earnings before income taxes 29,034       24,239    
           
    Income tax expense 7,516       5,899    
    Net earnings $ 21,518       $ 18,340    
           
    Earnings per share      
    Basic $ 0.41       $ 0.35    
    Diluted $ 0.40       $ 0.34    
           
    Weighted-average shares outstanding      
    Basic 52,534,787       52,336,443    
    Diluted 53,581,051       53,985,385    


    CONTACTS:

    Jack A. Khattar, President and CEO
    Gregory S. Patrick, Senior Vice President and CFO
    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:

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