Supernus Announces Second Quarter 2021 Financial Results


  • Second quarter 2021 total revenues of $141.3 million, a 12% increase compared to 2020
  • Qelbree™ launched in the U.S. for pediatric ADHD at the end of May 2021
  • Qelbree sNDA for adult ADHD submitted to the FDA
  • SPN-830 (apomorphine infusion pump) NDA resubmission anticipated in the second half of 2021

ROCKVILLE, Md., Aug. 04, 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 second quarter of 2021, and associated Company developments.

“The approval and commercial launch of Qelbree for pediatric patients with ADHD mark an important milestone for children and families searching for new treatment options for ADHD,” said Jack Khattar, President and CEO of Supernus Pharmaceuticals.   “As a non-controlled substance that has a unique profile of proven efficacy, safety and tolerability, Qelbree provides patients living with ADHD a novel treatment option like no other ADHD medication.”

Net Product Sales

Second quarter 2021 net product sales were $138.6 million, 12% higher than the same period in 2020.

Net Product Sales     
($ in millions)Q2 2021 Q2 2020 (1) Change %
Trokendi XR®$78.8 $89.7 (12)%
Oxtellar XR®25.0 23.7 6 %
APOKYN®27.0 8.6 **
MYOBLOC®4.6 1.2 **
XADAGO®2.9 0.8 **
Qelbree0.3  **
Net Product Sales$138.6 $124.0 12 %

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(1) Net product sales of APOKYN, MYOBLOC and XADAGO from June 9, 2020 to June 30, 2020.

Qelbree Launch Update

  • At the end of May 2021, Supernus launched Qelbree for the treatment of attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age. Net product sales for the second quarter of 2021 were $0.3 million.  
  • The early performance of Qelbree is on track with our expectations. Current trends in prescriptions reflect the heavy sampling programs with patients. Over 25,000 starter kits have been distributed to physicians since the launch and in preparation for the back-to-school season.
  • Early clinical feedback about the performance of Qelbree in patients is positive and in line with the Phase III clinical results.

Product Pipeline Update

Qelbree (viloxazine, extended-release capsules) - Novel non-stimulant for the treatment of ADHD in adults

  • The Company recently submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Qelbree for adult patients with ADHD.

SPN-830 (apomorphine infusion pump) - Continuous treatment of motor fluctuations (“on-off” episodes) in Parkinson's disease (PD)

  • The Company continues to plan to resubmit the SPN-830 NDA in the second half of 2021.  

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

  • A randomized Phase II clinical study of SPN-820 in treatment-resistant depression is expected to start by the end of 2021.

Financial Highlights

Second quarter 2021 operating earnings were $34.1 million, as compared to $45.5 million in the second quarter of 2020.   Operating earnings for the second quarter of 2021 included amortization of intangible assets expense of $5.9 million, compared to $2.4 million in the second quarter of 2020.  

Second quarter 2021 net earnings and diluted earnings per share were $23.7 million and $0.43, respectively, as compared to $34.7 million, or $0.65 per diluted share, in the same period last year.

As of June 30, 2021, the Company had $855.3 million in cash, cash equivalents, current and long-term marketable securities, compared to $772.9 million as of December 31, 2020.    

Full Year 2021 Financial Guidance

For full year 2021, the Company reiterates its prior financial guidance including an increase to the lower end of its operating earnings guidance as set forth below:

 Full Year 2021 Guidance
($ in millions)
Total revenues (1)$550 - $580
Combined R&D and SG&A expenses (2)$380 - $410
Operating earnings (3)$70 - $90
Amortization of intangible assets$24
Effective tax rate(4)28% - 31%

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(1) Total revenues include net product sales and royalty revenue. Includes $10 million for Qelbree 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 (gain). Reflects an increase from the original guidance of $65 - $90 million.
(4) The full year 2021 effective tax rate guidance of 28% - 31% is above the normally expected range of 26% - 28% due to the effect of discrete tax items in the period.

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, today, August 4, 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:1687420
Conference Call Name:Supernus Pharmaceuticals Second Quarter 2021 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 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, 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.

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

 June 30, 2021 December 31, 2020
 (unaudited)  
Assets   
Current assets   
Cash and cash equivalents$223,771   $288,640  
Marketable securities186,070   133,893  
Accounts receivable, net137,275   140,877  
Inventories, net58,391   48,325  
Prepaid expenses and other current assets33,737   18,682  
Total current assets639,244   630,417  
Long term marketable securities445,473   350,359  
Property and equipment, net17,065   37,824  
Intangible assets, net352,628   364,342  
Goodwill77,963   77,911  
Other assets40,687   43,249  
Total assets$1,573,060   $1,504,102  
    
Liabilities and stockholders’ equity   
Current liabilities   
Accounts payable and accrued liabilities$79,993   $78,934  
Accrued product returns and rebates173,598   126,192  
Contingent consideration, current portion23,540   30,900  
Other current liabilities6,316   9,082  
Total current liabilities283,447   245,108  
Convertible notes, net370,383   361,751  
Contingent consideration, long term45,430   45,800  
Operating lease liabilities, long term36,143   28,579  
Deferred income tax liabilities32,986   35,215  
Other liabilities19,092   42,791  
Total liabilities787,481   759,244  
    
Stockholders’ equity   
Common stock, $0.001 par value; 130,000,000 shares authorized; 53,144,759 and 52,868,482 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively53   53  
Additional paid-in capital424,175   409,332  
Accumulated other comprehensive earnings, net of tax5,433   8,975  
Retained earnings355,918   326,498  
Total stockholders’ equity785,579   744,858  
Total liabilities and stockholders’ equity$1,573,060   $1,504,102  

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

 Three Months ended
June 30,
 Six Months ended
June 30,
 2021 2020 2021 2020
 (unaudited) (unaudited)
Revenues       
Net product sales$138,628  $123,984  $267,009  $216,474 
Royalty revenues2,701  2,745  5,252  5,231 
Total revenues141,329  126,729  272,261  221,705 
        
Costs and expenses       
Cost of goods sold (a)25,028  8,386  39,982  12,538 
Research and development15,455  22,247  49,735  41,184 
Selling, general and administrative69,535  48,103  130,992  89,717 
Amortization of intangible assets5,948  2,445  11,955  3,706 
Contingent consideration gain(8,750)   (7,730)  
Total costs and expenses107,216  81,181  224,934  147,145 
        
Operating earnings34,113  45,548  47,327  74,560 
        
Other income (expense)       
Interest expense(5,467) (5,815) (11,564) (11,570)
Interest and other income, net2,589  7,477  6,401  13,254 
Total other income (expense)(2,878) 1,662  (5,163) 1,684 
        
Earnings before income taxes31,235  47,210  42,164  76,244 
        
Income tax expense7,509  12,543  12,744  20,059 
Net earnings$23,726  $34,667  $29,420  $56,185 
        
Earnings per share       
Basic$0.45  $0.66  $0.56  $1.07 
Diluted$0.43  $0.65  $0.54  $1.05 
        
Weighted-average shares outstanding       
Basic53,005,344  52,557,035  52,985,472  52,545,910 
Diluted54,724,146  53,645,828  54,601,533  53,611,418 

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(a) Excludes amortization of acquired intangible assets

CONTACTS:

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: peter.vozzo@westwicke.com