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Supernus Announces Record Fourth Quarter and Full Year 2015 Financial Results

  • Net product sales for fourth quarter 2015 were $42.6 million, a 39.6% increase over the same quarter of 2014 and a 10.5% increase over third quarter 2015.
     
  • Net product sales for full year 2015 were $143.5 million, a 60.2% increase over full year 2014.
     
  • Operating income for fourth quarter 2015 was $6.8 million, a 44.8% increase over operating income of $4.7 million in the same quarter of 2014.      
     
  • Achieved first full year of profitability from on-going operations in 2015, with operating income of $17.7 million.  Excluding the impact of a onetime $30.0 million royalty monetization payment in the third quarter of 2014, operating loss was $5.8 million for full year 2014.
     
  • Finalized the special protocol assessment (SPA) for the SPN-810 Phase III trial with the FDA in the fourth quarter of 2015. The Company remains on schedule with the Phase III program for SPN-810 for the treatment of Impulsive Aggression in ADHD and the Phase IIb program for SPN-812 for the treatment of ADHD.

ROCKVILLE, Md., March 02, 2016 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today reported financial results for fourth quarter and full year 2015 and associated company developments.

Commercial Update

Fourth quarter 2015 product prescriptions for Trokendi XR® and Oxtellar XR®, as reported by IMS, totaled 111,627, a 61.3% increase over the fourth quarter of 2014 and an increase of 10.8% over the third quarter of 2015. Full year 2015 product prescriptions for Trokendi XR® and Oxtellar XR® totaled 378,173, a 90.6% increase over full year 2014.

    Prescriptions Increase in Prescriptions (%)
    Q4 2015 Q3 2015 Q4 2014  Q4 15 vs. Q3 15
  Q4 15 vs. Q4 14
               
Trokendi XR 83,899 75,104 49,220  11.7         70.5 %
Oxtellar XR 27,728 25,666 19,988  8.0         38.7 %
  Total 111,627 100,770 69,208  10.8         61.3 %
                 
                 
      Prescriptions   Increase in Prescriptions (%)    
    FY 2015 FY 2014 FY 2015 vs. FY 2014    
                 
Trokendi XR 279,782 135,238     106.9 %      
Oxtellar XR 98,391 63,153     55.8 %      
  Total 378,173 198,391     90.6 %      
                     

Source: Product prescriptions as reported by IMS

“2015 was a year of significant achievements, where we delivered on our commercial strategy for Trokendi XR and Oxtellar XR, and progressed our pipeline into late-stage clinical testing,” said Jack Khattar, President and CEO of Supernus Pharmaceuticals. “We met our upwardly revised product sales guidance, with total net product sales reaching $143.5 million in 2015. Based on the strength of our base business, we were able to achieve, for the first time, profitability from on-going operations each quarter and for the full year. We also filed a supplemental new drug application during the year requesting a label expansion for Trokendi XR to include treatment in adults for migraine headache, which was accepted for review by the FDA. Finally, we continue to defend vigorously our novel products and build upon our strong intellectual property position, as evidenced by the recent favorable Federal court ruling on Oxtellar XR and the settlement agreement we entered into with Par Pharmaceuticals in 2015 for Trokendi XR.”   

Progress of Product Pipeline

The Company remains on schedule with its two Phase III trials for SPN-810 and the Phase IIb trial for SPN-812. During the first quarter, we are actively recruiting and screening patients for all trials.  Phase III data for SPN-810 is expected to be available by mid 2017, and data from the SPN-812 Phase IIb trial is expected to be available by early 2017.

During the fourth quarter of 2015, the Company finalized the SPA for SPN-810 with the FDA, conducted an investigator meeting with approximately 50 participating centers covering both Phase III trials, and began site initiation visits.

Regarding SPN-812, during the fourth quarter of 2015 final results were received from a single-ascending dose (SAD) study and a multiple-ascending dose (MAD) study in adult healthy volunteers. These data showed an overwhelmingly favorable adverse event profile for our extended-release formulation at doses that are several multiples of the effective doses used in the immediate release formulation in the Phase IIa study.  

“We are very excited about the emerging clinical profile of SPN-812. Data from our SAD and MAD studies reinforce our belief that SPN-812 has the potential for being dosed at levels high enough to compare favorably with stimulant medications for efficacy, while still showing a favorable tolerability and safety profile,” said Jack Khattar, President and CEO of Supernus Pharmaceuticals.

Revenues and Gross Margin

Net product sales for the fourth quarter of 2015 were $42.6 million, a 39.6% increase over $30.5 million in the same period last year and a 10.5% increase over $38.6 million in the third quarter of 2015. Net product sales for full year 2015 were $143.5 million, a 60.2% increase over $89.6 million in 2014.

      Net Product Sales ($mil.)     Increase in Net Product Sales (%)
    Q4 2015 Q3 2015 Q4 2014   Q4 15 vs. Q3 15 Q4 15 vs. Q4 14
                   
Trokendi XR $ 33.3   $ 29.9   $ 22.9       11.4 %     45.5 %  
Oxtellar XR $ 9.3   $ 8.7   $ 7.6       6.9 %     22.4 %  
                   
  Total $ 42.6   $ 38.6   $ 30.5       10.5 %     39.6 %  
                   
                   
    Net Product Sales ($mil.)
  Increase in Net Product Sales (%)  
    FY 2015 FY 2014     FY 2015 vs. FY 2014   
                   
Trokendi XR $ 110.3   $ 64.9           70.1 %  
Oxtellar XR $ 33.2   $ 24.7           34.4 %  
               
  Total $ 143.5   $ 89.6           60.2 %  
                               

 

Total revenue for full year 2015 was $144.4 million, compared to $122.0 million for full year 2014. Total revenue for 2015 consisted almost exclusively of net product sales while total revenue for 2014 included the impact of a onetime $30.0 million royalty monetization. 

Gross margin was 93.4% and 94.1% for the fourth quarter and full year 2015, respectively, compared to 92.5% and 93.6% for the comparable periods in 2014.

Operating Expenses

Research and development expenses in the fourth quarter of 2015 were $9.4 million, as compared to $5.8 million in the same quarter last year. This increase is primarily due to the initiation of Phase III testing associated with SPN-810 during the third quarter of 2015 and the initiation of Phase IIb testing of SPN-812 during the fourth quarter of 2015. Research and development expenses for full year 2015 were $29.1 million, as compared to $19.6 million in 2014. This increase is primarily due to increased clinical development activities associated with the initiation of our late-stage studies for SPN-810 and SPN-812, including the manufacture of clinical supplies and the screening of clinical trial sites.

Selling, general and administrative expenses in the fourth quarter of 2015 were $23.6 million, as compared to $18.0 million in the same quarter last year. Selling, general and administrative expenses were $89.2 million in 2015, compared to $72.5 million in 2014. The higher expenses in the fourth quarter and the full year 2015, compared to the year earlier periods, reflect increased promotional and marketing activities to support the growth of Trokendi XR and Oxtellar XR, as well as work done in anticipation of launching the migraine headache indication for Trokendi XR in 2016.

Operating Income and Earnings Per Share

For the first time, the Company was profitable from ongoing operations for the full year as well as in each quarter of the year. Operating income in the fourth quarter of 2015 was $6.8 million, an increase of 44.8% over operating income of $4.7 million in the same period last year. Full year 2015 operating income was $17.7 million.  Excluding the impact of a $30.0 million royalty monetization payment, operating loss for 2014 was $5.8 million.  The substantial improvement in operating income for 2015 reflects the strength and growth of the Company’s base business.

Diluted earnings per share were $0.14 in the fourth quarter ended December 31, 2015, compared to $0.10 in the same period last year. Diluted earnings per share were $0.28 in 2015, compared to a loss of $0.24 in 2014, excluding the impact of a $30.0 million royalty monetization.

Weighted-average diluted common shares outstanding were approximately 49.6 million and 51.2 million in the fourth quarter and full year of 2015, respectively, as compared to approximately 43.2 million and 50.6 million in the respective periods the prior year.

Capital Resources

As of December 31, 2015, the Company had $117.2 million in cash, cash equivalents, marketable securities, and long term marketable securities, as compared to $94.2 million at December 31, 2014.   

Financial Guidance

For full year 2016, the Company estimates that net product sales will range from $200 million to $210 million, with operating income ranging from $28 million to $35 million.

The Company expects that research and development expenses in 2016 will range from $55 million to $65 million as the Company progresses late-stage development of SPN-810 and SPN-812.

Conference Call Details

The Company will hold a conference call hosted by Jack Khattar, President and Chief Executive Officer, and Greg Patrick, Vice President and Chief Financial Officer, to discuss these results at 9:00 a.m. ET, on Thursday, March 3, 2016. An accompanying webcast also will be provided.

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:                       47017444
Conference Call Name:          Supernus Pharmaceuticals 4Q and Full Year 2015 Earnings Conference Call

Following the live call, a replay will be available on the Company's website, www.supernus.com, under ‘Investors’.

About Supernus Pharmaceuticals, Inc.

Supernus Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases. The Company has two marketed products for epilepsy, Oxtellar XR® (extended-release oxcarbazepine) and Trokendi XR® (extended-release topiramate). The Company is also developing several product candidates to address large market opportunities in psychiatry, including SPN-810 for the treatment of impulsive aggression in ADHD patients. SPN-812 is being developed for treatment of ADHD.

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 SEC filings 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)
             
      December 31, 2015     December 31, 2014
      (unaudited)      
             
Cash, cash equivalents and marketable securities   $ 62,190   $ 74,336
Accounts receivable, net       25,908       17,270
Inventories, net       12,587       13,441
Prepaid expenses and other current assets       5,292       3,845
Total Current Assets       105,977       108,892
             
Long term marketable securities       55,009       19,816
Property and equipment, net       3,874       2,448
Deferred legal fees       22,503       5,209
Intangible assets, net       976       225
Other non-current assets       391       918
Total Assets   $ 188,730   $ 137,508
             
Accounts payable   $ 4,314   $ 1,863
Accrued sales deduction     26,794     8,461
Accrued expenses     24,813     17,026
Deferred licensing revenue     176       143
Total Current Liabilities       56,097       27,493
             
Deferred licensing revenue, net of current portion       1,390       1,274
Convertible notes, net of discount       7,189       26,947
Other non-current liabilities       4,325       3,876
Derivative liabilities       854       6,564
Total Liabilities       69,855       66,154
             
Total Stockholders' Equity       118,875       71,354
Total Liabilities & Stockholders' Equity $ 188,730   $ 137,508

 

Supernus Pharmaceuticals, Inc.
Consolidated Statements of Operations
(in thousands, except share and per share data)
                       
  Three Months ended December 31,   Year ended December 31,
  2015   2014   2015   2014
                       
  (unaudited)   (unaudited)      
Revenue                       
Net product sales $     42,611     $     30,515     $     143,526     $     89,571  
Revenue from royalty agreement                               30,000  
Licensing revenue       44           286           901           2,474  
                       
Total revenue       42,655           30,801           144,427           122,045  
                       
Costs and expenses                      
Cost of product sales       2,794           2,282           8,423           5,758  
Research and development       9,446           5,772           29,135           19,586  
Selling, general and administrative       23,566           18,018           89,204           72,471  
                       
Total costs and expenses       35,806           26,072           126,762           97,815  
                       
Operating income       6,849           4,729           17,665           24,230  
                       
Other income (expense)                      
Interest income       225           83           643           348  
Interest expense       (225 )         (1,189 )         (1,229 )         (4,963 )
Changes in fair value of derivative liabilities       127           694           193           2,809  
Loss on extinguishment of debt       62                   (2,338 )         (2,592 )
Other income       8           37           38           39  
                       
Total other expense       197           (375 )         (2,693 )         (4,359 )
                       
Earnings before income taxes       7,046           4,354           14,972           19,871  
                       
Income tax expense       174                   956          
                       
Net income  $     6,872      $      4,354     $     14,016      $      19,871  
                       
Income per common share:                      
Basic $     0.14     $     0.10     $     0.30     $     0.47  
Diluted $     0.14     $     0.10     $     0.28     $     0.32  
                       
Weighted-average number of common shares:                      
Basic       48,891,847           42,931,146           47,485,258           42,260,896  
Diluted       49,598,030           43,201,227           51,160,380           50,583,511  

 

Summary of Non-GAAP Adjustments 
(in thousands, except per share data)
      Adjustment  
      Revenue from  
    GAAP Royalty Agreement Non-GAAP
         
Year ended December 31, 2014      
  Total Revenue $   122,045   $   (30,000 ) $   92,045  
  Operating income      24,230       (30,000 )     (5,770 )
  Net income (loss)     19,871       (30,000 )     (10,129 )
         
  Income (loss) per common share-basic     0.47           (0.24 )
  Income (loss) per common share-diluted     0.32           (0.24 )
         
  Weighted-average number of common shares:          
  Basic     42,260,896         42,260,896  
  Diluted     50,583,511         42,260,896  


CONTACTS:

Jack A. Khattar, President and CEO
Gregory S. Patrick, Vice President and CFO
Supernus Pharmaceuticals, Inc.
Tel: (301) 838-2591

or

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

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