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Supernus Announces Second Quarter 2018 Financial Results and Record Quarterly Revenue

  • Total revenue of $99.5 million, a 31% increase over 2017
  • Net product sales of $97.0 million, a 32% increase over 2017
  • Operating earnings of $35.7 million, a 37% increase over 2017
  • Diluted earnings per share (GAAP) of $0.57, a 78% increase over 2017
  • Completed enrollment in the first SPN-812 Phase III trial (P301), with data expected in the fourth quarter of 2018

ROCKVILLE, Md., Aug. 07, 2018 (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 record financial results for the second quarter of 2018 and related Company developments.

Commercial Update
Second quarter 2018 product prescriptions for Trokendi XR® and Oxtellar XR®, as reported by IQVIA, totaled 214,841, a 35.5% increase over the second quarter of 2017.

Prescriptions
 Q2 2018Q2 2017Change %
Trokendi XR177,052 124,08942.7%
Oxtellar XR 37,789 34,4689.6%
Total214,841158,55735.5%

Source:  IQVIA

Net product sales for the second quarter of 2018 were $97.0 million, a 32.3% increase over $73.3 million in the second quarter of 2017.

Net Product Sales ($ in millions)
 Q2 2018Q2 2017Change %
Trokendi XR$76.4$56.036.4%
Oxtellar XR$20.6$17.319.1%
Total$97.0$73.332.3%

“Solid commercial execution has enabled Supernus to generate another strong quarter of growth, setting a new record for both Trokendi XR and Oxtellar XR quarterly net product sales,” said Jack Khattar, President and CEO of Supernus Pharmaceuticals.

Progress of Product Pipeline
SPN-812 – Novel non-stimulant for the treatment of ADHD

  • The program consists of four three-arm, placebo-controlled trials: P301 and P302 trials in patients 6-11 years old, and P303 and P304 trials in adolescent patients.
  • Enrollment is complete in the P301 trial, with data expected in the fourth quarter of 2018.
  • The remaining three trials are at approximately 89% enrollment, with data expected in the first quarter of 2019.
  • Roll-over from the four Phase III trials to the open label extension study is approximately 90%.

SPN-810 – Treatment of Impulsive Aggression in patients with ADHD

  • Enrollment in the Phase III pediatric trials, P301 and P302, is approximately 91% and 77%, respectively.
  • The Company anticipates having data from P301 by the first quarter of 2019 and data from P302 by mid-2019.  
  • Roll-over from the two Phase III trials to the open label extension study continues at approximately 90%.
  • Patient screening has been initiated in the Phase III trial treating adolescents.

Oxtellar XR –Treatment of Bipolar Disorder

  • The Company is planning to initiate pivotal Phase III studies for treatment of bipolar disorder in the second half of 2019.

“As we enter the second half of 2018, we remain focused on the successful completion of our clinical programs and look forward to providing top-line data from the first Phase III trial for SPN-812 in the fourth quarter of 2018,” said Jack Khattar.

Operating Expenses
Research and development expenses in the second quarter of 2018 were $20.0 million, as compared to $10.8 million in the same quarter last year. The increase was due primarily to the initiation of the four Phase III clinical trials for SPN-812 in the second half of 2017 and to a lesser extent, the open-label extension trials for SPN-812 and SPN-810.

Selling, general and administrative expenses in the second quarter of 2018 were $40.1 million, as compared to $35.1 million in the same quarter last year. The increase was due to the expansion of the salesforce by 40 salespeople, which were fully deployed in the fourth quarter of 2017; marketing programs to support the Company’s commercial products; and an increase in share-based compensation.

Operating Earnings and Earnings Per Share
Operating earnings in the second quarter of 2018 were $35.7 million, a 37.0% increase over $26.1 million in the same period the prior year. The improvement in operating earnings was primarily due to increased net product sales, partially offset by increased operating expenses.

GAAP net earnings in the second quarter of 2018 were $30.7 million, as compared to $17.4 million in the same period last year. In addition to higher operating income, GAAP net earnings for the second quarter of 2018 benefited from the reduction in the statutory U.S. federal income tax rate and from stock option exercises.

GAAP diluted earnings per share (EPS) were $0.57 in the second quarter of 2018, compared to $0.32 in the second quarter of 2017. Net interest expense and non-cash deferred financing costs associated with the sale of $402.5 million of convertible senior notes in March 2018 had the effect of reducing GAAP net earnings by approximately $4.3 million, or $0.08 per diluted share, in the second quarter of 2018.

Weighted-average diluted common shares outstanding were approximately 54.2 million in the second quarter of 2018, as compared to approximately 53.2 million in the second quarter of 2017.

As of June 30, 2018, the Company had $677.7 million in cash, cash equivalents, marketable securities and long term marketable securities, as compared to $273.7 million at December 31, 2017. This increase reflects net proceeds of $364.9 million from the issuance of convertible senior notes and warrants, partially offset by purchases of convertible note hedges in March 2018, as well as increased cash from operations in the six months ended June 30, 2018.  

Financial Guidance
For full year 2018, the Company is updating its prior guidance as set forth below:

  • Net product sales in the range of $385 million to $400 million, compared to the previously expected range of $375 million to $400 million.
  • Research and development expenses of approximately $80 million.
  • Operating earnings in the range of $130 million to $140 million, compared to the previously expected range of $125 million to $135 million. The Company continues to expect approximately $7 million of licensing and non-cash royalty revenue.
  • The Company expects an effective tax rate of approximately 23% to 25% for the third and fourth quarters of 2018.

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. Eastern Time, on Wednesday, August 8, 2018. 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: 7484048
Conference Call Name: Supernus Pharmaceuticals Second Quarter 2018 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 specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system 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 psychiatry, including SPN-810 for the treatment of Impulsive Aggression in ADHD patients and SPN-812 for the 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 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.
Consolidated Balance Sheets
(in thousands, except share amounts)
       
  June 30, December 31, 
  2018  2017 
Assets (unaudited)   
Current assets      
Cash and cash equivalents $  35,205  $  100,304 
Marketable securities    139,208     39,736 
Accounts receivable, net    74,842     65,586 
Inventories, net    20,680     16,304 
Prepaid expenses and other current assets    14,581     6,521 
Total current assets    284,516     228,451 
Long term marketable securities    503,312     133,638 
Property and equipment, net    4,897     5,124 
Intangible assets, net    33,794     36,019 
Other non-current assets    752     389 
Deferred income taxes    25,528     20,843 
       
Total assets $  852,799  $  424,464 
       
Liabilities and stockholders' equity      
Current liabilities      
Accounts payable $  2,943  $  6,844 
Accrued sales deductions    70,044     68,343 
Accrued expenses    29,288     27,305 
Income taxes payable    —      15,938 
Non-recourse liability related to sale of future royalties, current portion     1,659     4,283 
Deferred licensing revenue    —      287 
Total current liabilities    103,934     123,000 
Deferred licensing revenue, net of current portion    —      1,149 
Convertible notes, net     321,920     —  
Non-recourse liability related to sale of future royalties, long term    23,867     22,258 
Other non-current liabilities    12,586     10,577 
Total liabilities    462,307     156,984 
       
Stockholders' equity      
Common stock, $0.001 par value, 130,000,000 shares authorized at      
June 30, 2018 and December 31, 2017; 52,179,334 and 51,314,850 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively    52     51 
Additional paid-in capital    361,971     294,999 
Accumulated other comprehensive loss, net of tax     (4,119)    (747)
Retained earnings (accumulated deficit)    32,588     (26,823)
Total stockholders' equity    390,492     267,480 
       
Total liabilities and stockholders' equity $  852,799  $  424,464 
       


            
Supernus Pharmaceuticals, Inc.
Consolidated Statements of Earnings
(in thousands, except share and per share data)
            
 Three Months ended June 30, Six Months ended June 30,
 2018  2017   2018  2017 
                
 (unaudited) (unaudited)
Revenue            
Net product sales$  97,030  $  73,328  $  186,150  $  129,697 
Royalty revenue    1,758     1,179     3,067     2,328 
Licensing revenue   750     1,322     750     1,380 
            
Total revenue   99,538     75,829     189,967     133,405 
            
Costs and expenses           
Cost of product sales   3,683     3,861     6,961     6,809 
Research and development   20,038     10,823     38,946     20,425 
Selling, general and administrative   40,097     35,078     76,946     63,316 
            
Total costs and expenses   63,818     49,762     122,853     90,550 
            
Operating earnings    35,720     26,067     67,114     42,855 
Other income (expense)           
Interest income   3,664     656     4,870     1,187 
Interest expense   (4,324)    (58)    (5,041)    (147)
Interest expense-nonrecourse
  liability related to sale of future royalties
   (1,204)    (160)    (1,905)    (1,119)
Changes in fair value of derivative liabilities   —      23     —      76 
Loss on extinguishment of debt   —      (103)    —      (204)
            
Total other income (expense)   (1,864)    358     (2,076)    (207)
            
Earnings before income taxes   33,856     26,425     65,038     42,648 
            
Income tax expense   3,119     9,057     7,949     14,983 
            
Net earnings $  30,737  $  17,368  $  57,089  $  27,665 
            
Earnings per share:           
Basic$  0.59  $  0.34  $1.10  $0.55 
Diluted$  0.57  $  0.32  $1.06  $0.52 
            
Weighted-average number of common shares outstanding:          
Basic   51,919,894     50,530,968     51,729,243     50,345,830 
Diluted   54,203,308     53,223,714     54,021,941     53,026,323 
            


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

Tuesday, August 7, 2018 - 16:15