Supernus Announces Third Quarter 2020 Financial Results

November 3, 2020 at 4:30 PM EST
  • Q3 2020 total revenues of $155.1 million, including net product sales of $152.1 million and royalty revenues of $3.0 million
  • Q3 2020 operating earnings of $56.1 million
  • On track to initiate commercial launch of SPN-812 in January 2021, if approved by the FDA
  • Topline data from the SPN-812 Phase III trial in adult ADHD patients expected in Q1 2021
  • Submitted SPN-830 (Apomorphine infusion pump) NDA to the FDA in September 2020
  • Increased full year 2020 net product sales guidance range of $500 million to $525 million, and operating earnings guidance range of $145 million to $160 million

ROCKVILLE, Md., Nov. 03, 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 third quarter of 2020 and associated Company developments.

“During the first nine months of 2020, we delivered strong product sales growth, diversified our revenue base and enhanced our long term growth with two corporate transactions” said Jack Khattar, President and CEO of Supernus. “Our employees have been hard at work in anticipation of the launch of SPN-812. Based on the efficacy and safety demonstrated in its clinical program, SPN-812 can potentially offer an important new option in the treatment of ADHD.”      

Commercial Update

Third quarter 2020 net product sales were $152.1 million, 52% higher than the same period in 2019, driven by the addition of $40.9 million of net product sales from the acquired commercial products and $11.2 million in net product sales growth from Trokendi XR and Oxtellar XR.

Net Product Sales
($ in millions)
  Q3 2020   Q3 2019 Change %
Trokendi XR $ 82.9      $ 77.3    7 %
Oxtellar XR 28.3      22.7    25 %
APOKYN 34.5      —    NM(1)
XADAGO 2.3      —    NM(1)
MYOBLOC 4.1      —    NM(1)
Total $ 152.1      $ 100.0    52 %

____________
(1) Fluctuation in terms of percentage change is not meaningful.

Product Pipeline Update

SPN-812 - Novel non-stimulant for the treatment of ADHD in children and adults

  • The Company continues to prepare for the commercial launch of SPN-812, which is expected in January 2021, if approved by the FDA. The New Drug Application (NDA) Prescription Drug User Fee Act (PDUFA) target action date is November 8, 2020.
  • The Company completed enrollment in the SPN-812 Phase III trial in adult patients with ADHD. Topline data from the trial is expected in the first quarter of 2021.

SPN-830 (Apomorphine infusion pump) - Continuous treatment of motor fluctuations (“on-off” episodes) in PD

  • NDA was submitted to the U.S. Food and Drug Administration (FDA) in September 2020 for the continuous treatment of "on-off" episodes in adults with Parkinson's disease (PD) whose motor control is unsatisfactory with oral levodopa and at least one other noninvasive PD therapy.
  • The Company expects to launch SPN-830 in the fourth quarter of 2021, if approved by the FDA.

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

  • Preclinical and development activities are ongoing, with the goal of initiating a Phase II clinical program in treatment-resistant depression by the end of 2021.   

Operating Expenses

Research and development (R&D) expenses in the third quarter of 2020 were $16.8 million, essentially unchanged from $16.9 million in the same quarter last year.

Selling, general and administrative (SG&A) expenses in the third quarter of 2020 were $54.7 million, compared to $39.3 million in the same quarter last year. This increase was primarily due to costs associated with the new CNS portfolio of commercial products acquired from US WorldMeds (USWM Acquisition) in the second quarter of 2020 and our ongoing preparations for the potential launch of SPN-812. 

Amortization expense of intangible assets in the third quarter of 2020 were $6.1 million, compared to $1.3 million in the same quarter last year. This increase results from the USWM Acquisition.

Operating Earnings and Earnings Per Share

Operating earnings (GAAP) in the third quarter of 2020 were $56.1 million, compared to $39.7 million in the third quarter of 2019. Net earnings (GAAP) in the third quarter of 2020 were $40.0 million, or $0.74 per diluted share, as compared to $28.9 million, or $0.54 per diluted share, in the same period last year.

Balance Sheet Highlights

As of September 30, 2020, the Company had $740.1 million in cash, cash equivalents, marketable securities and long term marketable securities, compared to $938.8 million at December 31, 2019. During the first nine months of 2020, the Company generated $107.5 million of cash from operations, inclusive of net changes in working capital. The Company made cash payments of approximately $300 million for acquisition of the CNS portfolio of US WorldMeds and $25 million paid to Navitor upon executing the development and option agreement for SPN-820.         

Financial Guidance

The Company is revising full year 2020 financial guidance, which consists of the following components, inclusive of the impact of acquiring the CNS portfolio of US WorldMeds as of June 9, 2020:

($ in millions) Current (As of November 3, 2020)   Previous (As of August 18, 2020)
Net product sales $500 - $525   $460 - $500
Research and development expense Approximately $75   Approximately $85
Selling, general and administrative expense $215 - $225   $240 - $250
Amortization of intangible assets $16   $15  
Operating earnings (GAAP) $145 - $160, including amortization of intangible assets   $90 - $110, including amortization of intangible assets

Conference Call Details

The Company will hold a conference call hosted by Jack Khattar, President and Chief Executive Officer and the executive management team to discuss these results at 9:00 a.m. Eastern Time, on Wednesday, November 4, 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: 1882244
Conference Call Name: Supernus Pharmaceuticals Third 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 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 for treatment-resistant depression; and SPN-817 for the treatment of epilepsy.

See full Prescribing Information for our products here: Trokendi XR, Oxtellar XR, APOKYN, MYOBLOC, and XADAGO

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.


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

  September 30,   December 31,
  2020   2019
  (unaudited)    
Assets      
Current assets      
Cash and cash equivalents $ 204,293     $ 181,381  
Marketable securities 147,657     165,692  
Accounts receivable, net 133,107     87,332  
Inventories, net 42,465     26,628  
Prepaid expenses and other current assets 24,493     11,611  
Total current assets 552,015     472,644  
Long term marketable securities 388,185     591,773  
Property and equipment, net 17,395     17,068  
Operating lease assets 21,019     21,279  
Finance lease asset 21,676      
Intangible assets, net 402,265     24,840  
Goodwill 89,143      
Deferred income tax assets     32,063  
Other assets 18,324     615  
Total assets $ 1,510,022     $ 1,160,282  
       
Liabilities and stockholders’ equity      
Current liabilities      
Accounts payable $ 11,193     $ 10,141  
Accrued product returns and rebates 136,973     107,629  
Accrued expenses and other current liabilities 56,289     34,305  
Contingent consideration, current portion 82,900      
Income taxes payable     2,443  
Operating lease liabilities, current portion 3,741     2,825  
Finance lease liability, current portion 3,612      
Nonrecourse liability related to sale of future royalties, current portion 4,898     3,244  
Total current liabilities 299,606     160,587  
Convertible notes, net 357,521     345,170  
Contingent consideration, long term 33,000      
Nonrecourse liability related to sale of future royalties, long term 14,960     19,248  
Operating lease liabilities, long term 29,522     30,440  
Finance lease liability, long term 19,289      
Deferred income tax liabilities 37,941      
Other liabilities 9,304     9,409  
Total liabilities 801,143     564,854  
       
Stockholders’ equity      
Common stock, $0.001 par value; 130,000,000 shares authorized; 52,670,121 and 52,533,348 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively 53     53  
Additional paid-in capital 403,396     388,410  
Accumulated other comprehensive earnings, net of tax 9,700     7,417  
Retained earnings 295,730     199,548  
Total stockholders’ equity 708,879     595,428  
       
Total liabilities and stockholders’ equity $ 1,510,022     $ 1,160,282  



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

  Three Months ended
September 30,
  Nine Months ended
September 30,
  2020   2019   2020   2019
  (unaudited)   (unaudited)
Revenues              
Net product sales $ 152,133       $ 100,034       $ 368,607       $ 285,491    
Royalty revenues 3,002       2,106       8,233       6,818    
Total revenues 155,135       102,140       376,840       292,309    
               
Costs and expenses              
Cost of goods sold(a) 21,388       4,819       33,926       12,547    
Research and development 16,839       16,943       58,023       49,307    
Selling, general and administrative 54,660       39,343       144,377       118,782    
Amortization of intangible assets 6,108       1,306       9,814       3,918    
Total costs and expenses 98,995       62,411       246,140       184,554    
               
Operating earnings 56,140       39,729       130,700       107,755    
               
Other income (expense)              
Interest income 3,262       5,559       12,988       15,696    
Interest expense (6,088 )     (5,662 )     (17,658 )     (16,930 )  
Other income (expense), net (603 )     (36 )     2,925       54    
Total other expense (3,429 )     (139 )     (1,745 )     (1,180 )  
               
Earnings before income taxes 52,711       39,590       128,955       106,575    
               
Income tax expense 12,714       10,730       32,773       26,648    
Net earnings $ 39,997       $ 28,860       $ 96,182       $ 79,927    
               
Earnings per share              
Basic $ 0.76       $ 0.55       $ 1.83       $ 1.53    
Diluted $ 0.74       $ 0.54       $ 1.79       $ 1.48    
               
Weighted-average shares outstanding              
Basic 52,658,850       52,453,384       52,583,891       52,392,232    
Diluted 53,762,642       53,805,838       53,663,273       53,898,486    

___________________________________________

(a) Excludes amortization of acquired intangible assets

CONTACTS:

Jack A. Khattar, President and Chief Executive Officer
Jim Kelly, EVP & Chief Financial Officer
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: peter.vozzo@westwicke.com

 


Supernus Pharmaceuticals, Inc.

Source: Supernus Pharmaceuticals, Inc.