Market Overview

Supernus Announces Second Quarter 2019 Financial Results

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  • Total revenue of $104.7 million, a 5.2% increase over 2018
  • Net product sales of $102.4 million, a 5.5% increase over 2018
  • Operating earnings of $42.6 million, a 19.3% increase over 2018
  • Submission of New Drug Application for SPN-812 on track for the second half of 2019
  • Revising full year 2019 net product sales guidance range to $400 million - $410 million and full year 2019 operating earnings range to $150 million - $160 million

ROCKVILLE, Md., Aug. 06, 2019 (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 second quarter of 2019 and associated Company developments.

Commercial Update

Second quarter 2019 product prescriptions for Trokendi XR® and Oxtellar XR®, as reported by IQVIA, totaled 209,066, a 7.4% increase over the second quarter of 2018.

Prescriptions
  Q2 2019     Q2 2018   Change %  
Trokendi XR 168,682     158,568   6.4 %
Oxtellar XR 40,384     36,066   12.0 %
Total 209,066     194,634   7.4 %

Source:  IQVIA

Net product sales for the second quarter of 2019 were $102.4 million, a 5.5% increase over $97.0 million in the second quarter of 2018. Net product sales by product are as follows:

Net Product Sales
($ in millions)
  Q2 2019     Q2 2018 Change %
Trokendi XR 78,964     76,474   3.3 %
Oxtellar XR 23,394     20,556   13.8 %
Total 102,358     97,030   5.5 %

"Prescription growth for Trokendi XR improved by 4.8% in the second quarter of 2019 as compared to the first quarter of 2019, but not to the degree we had expected," said Jack Khattar, President and CEO of Supernus. "Following the abnormally large seasonal decline we experienced in the first quarter of 2019, reflecting the impact of high deductible managed care programs, prescription growth for Trokendi XR has been hindered by a moderate contraction in the overall topiramate market. In addition, sales deductions, particularly rebates, have not improved in the second quarter of 2019 relative to the first quarter of 2019 as we had expected, but have remained relatively flat." Mr. Khattar added, "As a result, we are revising full year 2019 guidance for net product sales, and, to a lesser extent, operating earnings."

Progress of Product Pipeline

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

The Company concluded its pre-New Drug Application (NDA) clinical meeting with the U.S. Food and Drug Administration (FDA) in July 2019, and continues to expect to submit an NDA for SPN-812 in the second half of 2019. Pending FDA approval, the Company continues to expect to launch SPN-812 in the second half of 2020.
– The Company has advanced manufacture of SPN-812 to support the NDA submission and in preparation of commercial launch.
– A Phase III program in adult patients is anticipated to start in the fourth quarter of 2019.

SPN-810 - Novel treatment of Impulsive Aggression in patients with ADHD

– Enrollment in the Phase III P301 trial is complete, with data expected in the fourth quarter of 2019.
– Enrollment in the Phase III P302 trial continues, with data now expected in the first quarter of 2020.
– The Company continues to expect to submit an NDA for SPN-810 in the second half of 2020, and to launch SPN-810, pending FDA approval, in the second half of 2021.
– Enrollment in the open label extension (OLE) study continues at 90% or higher. On average, a patient in the OLE study remains on SPN-810 treatment for approximately 10.7 months, which the Company believes is an encouraging sign of the tolerability and efficacy of SPN-810.
– Patient dosing continues in the Phase III trial (P503) in adolescent patients.

SPN-604 - Novel treatment of bipolar disorder

– The Company remains on track to start a pivotal Phase III program for the treatment of bipolar disorder in the fourth quarter of 2019.

Operating Expenses

Research and development (R&D) expenses in the second quarter of 2019 were $17.0 million, as compared to $20.0 million in the same quarter last year. This decrease is primarily due to the completion of the four Phase III clinical trials for SPN-812, three of which were completed in December 2018 and the fourth in March 2019. Decreased expenses were partially offset by costs to manufacture SPN-812 to support the Company's upcoming submission of its NDA.

Selling, general and administrative expenses in the second quarter of 2019 were $41.1 million, essentially equivalent to $40.1 million in the same quarter last year.

Operating Earnings and Earnings Per Share

Operating earnings in the second quarter of 2019 were $42.6 million, a 19.3% increase from $35.7 million in the same quarter last year. Operating earnings increased faster than net product sales, which grew by 5.5%, demonstrating the Company's ability to manage operating expenses and leverage its established infrastructure.

Net earnings (GAAP) in the second quarter of 2019 were $32.7 million, or $0.61 per diluted share, an increase from $30.7 million, or $0.57 per diluted share, in the same period last year. Growth in net earnings was driven primarily from the aforementioned increase in operating earnings, partially offset by the higher effective tax rate in the second quarter of 2019 compared to the year earlier period. The effective tax rate in the second quarter of 2018 benefited from employees exercising stock options.

Weighted-average diluted common shares outstanding were approximately 53.9 million in the second quarter of 2019, as compared to approximately 54.2 million in the prior year period.

Balance Sheet Highlights

As of June 30, 2019, the Company had $852.3 million in cash, cash equivalents, marketable securities and long term marketable securities, compared to $774.8 million at December 31, 2018. This increase primarily reflects cash generated from operations in the first six months of 2019.

Financial Guidance

The Company is revising its full year 2019 guidance for net product sales and operating earnings, and reaffirming expectations for R&D expenses and the effective tax rate as set forth below:

–  Net product sales in the range of $400 million to $410 million, compared to the previously expected range of $435 million to $455 million.
–  R&D expenses in the range of $70 million to $80 million.
–  Operating earnings in the range of $150 million to $160 million, compared to the previously expected range of $160 million to $180 million.
–  Effective tax rate of approximately 23% to 25%.

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, August 7, 2019. 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: 1527779
Conference Call Name: Supernus Pharmaceuticals Second Quarter 2019 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-810 for the treatment of Impulsive Aggression in ADHD patients, SPN-812 for the treatment of ADHD and SPN-604 for the treatment of bipolar disorder.

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.
Condensed Consolidated Balance Sheets
(in thousands, except share amounts)

  June 30,   December 31,
  2019   2018
  (unaudited)    
Assets      
Current assets      
Cash and cash equivalents $ 87,344     $ 192,248  
Marketable securities 171,222     163,770  
Accounts receivable, net 84,564     102,922  
Inventories, net 26,024     25,659  
Prepaid expenses and other current assets 21,757     8,888  
Total current assets 390,911     493,487  
Long term marketable securities 593,754     418,798  
Property and equipment, net 4,028     4,095  
Intangible assets, net 28,787     31,368  
Lease assets 19,639      
Deferred income taxes 25,975     29,683  
Other assets 581     380  
       
Total assets $ 1,063,675     $ 977,811  
       
Liabilities and stockholders' equity      
Current liabilities      
Accounts payable $ 4,081     $ 3,195  
Accrued product returns and rebates 95,934     107,063  
Accrued expenses and other current liabilities 38,614     36,535  
Income taxes payable 2,674     12,377  
Non-recourse liability related to sale of future royalties, current portion 2,668     2,183  
Total current liabilities 143,971     161,353  
Convertible notes, net 337,210     329,462  
Non-recourse liability related to sale of future royalties, long term 21,100     22,575  
Lease liabilities, long term 27,535      
Other liabilities 10,955     11,398  
Total liabilities 540,771     524,788  
       
Stockholders' equity      
Common stock, $0.001 par value, 130,000,000 shares authorized 52,449,036 and 52,316,583 shares
 issued and outstanding as of June 30, 2019 and December 31, 2018, respectively
52     52  
Additional paid-in capital 379,369     369,637  
Accumulated other comprehensive earnings (loss), net of tax 5,924    
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