Nasdaq

Supernus Announces Third Quarter 2024 Financial Results

04-11-2024
  • Net sales of Qelbree® increased 68% in the third quarter of 2024, compared to the same period in 2023.
    • Net sales of Qelbree of $62.4 million and $166.9 million in the third quarter and first nine months of 2024, respectively.
  • Net sales of GOCOVRI® increased 8% in the third quarter of 2024, compared to the same period in 2023.
    • Net sales of GOCOVRI of $35.6 million and $93.9 million in the third quarter and first nine months of 2024, respectively.
  • Total revenues were $175.7 million in the third quarter of 2024, an increase of 14% compared to the same period in 2023.
    • Total revenues excluding Trokendi XR® and Oxtellar XR® net product sales (non-GAAP)(1) increased 26% in the third quarter of 2024, compared to the same period in 2023.
  • Operating earnings of $40.9 million and $60.3 million in the third quarter and first nine months of 2024, respectively, compared to operating earnings (loss) of $8.1 million and $(4.3) million for the same periods in 2023.
  • Adjusted operating earnings (non-GAAP)(1) were $67.7 million and $135.4 million in the third quarter and first nine months of 2024, respectively, compared to $37.3 million and $77.9 million in the same periods in 2023.
  • Raising full year 2024 guidance for total revenues and operating earnings (GAAP and Non-GAAP).

ROCKVILLE, Md., Nov. 04, 2024 (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 announced financial results for the third quarter of 2024 and associated Company developments.

Business Highlights

  • Total IQVIA prescriptions(2) for Qelbree were 194,025 in the third quarter of 2024, an increase of 19% compared to the same period in the prior year.
  • On August 16, 2024, the U.S. Food and Drug Administration acknowledged the resubmission of the Company’s New Drug Application for the apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations ("OFF" episodes) in Parkinson’s disease. The resubmission is considered filed, with a user fee goal date (PDUFA date) of February 1, 2025.

“For the third quarter and first nine months of 2024, strong performance from the Company’s key growth drivers – Qelbree and GOCOVRI – drove significant operating earnings growth,” said Jack Khattar, President and CEO of Supernus. “In addition to strong growth from our key drivers, we continue to advance our product pipeline, announcing positive topline data from our open-label Phase 2a study of SPN-820 in major depressive disorder.”

Product Pipeline Update

SPN-820 – Novel first-in-class molecule that increases mTORC1 mediated synaptic function for depression

  • In October 2024, the Company announced and discussed the data from its exploratory open-label Phase 2a clinical study of SPN-820 in adults with major depressive disorder (MDD). The data were based on 40 enrolled subjects, of which 38 completed the 10-day treatment period. The primary objective of the study was to assess efficacy in MDD, as well as the onset of efficacy. The Phase 2a study demonstrated rapid and substantial decrease in depressive symptoms, and 80% decrease in suicidal ideation. SPN-820 was well-tolerated with few adverse events.
  • In addition, the Company presented new data at the 2024 Psych Congress in October 2024 that demonstrate a rapid Montgomery–Asberg Depression Rating Scale (MADRS) response rate (≥50% reduction) and remission (MADRS ≤10), reaching 50.0% and 35.0% of participants, respectively, at 4 hours, with additional improvement to 84.2% and 63.2% of participants by Day 10.
  • The Company expects to complete enrollment in the ongoing Phase 2b multi-center randomized double-blind placebo-controlled parallel design study of SPN-820 in adults with treatment-resistant depression in November 2024. The study will examine the efficacy and safety of SPN-820 over a course of five weeks of treatment in approximately 236 patients in approximately 50 clinical sites. The primary outcome measure is the change from baseline to end of treatment period on the MADRS Total Score. Topline data from the Phase 2b trial are expected in the first half of 2025.

SPN-817 – Novel first-in-class highly selective AChE inhibitor for epilepsy

  • The Company is conducting an open label Phase 2a study in patients with treatment-resistant seizures. In May 2024, the Company announced data from a planned interim analysis from the initial stage of the study (Stage A). The Company has now completed enrollment of Stage A and is reporting topline data from all subjects with focal seizures who received the 3mg and 4mg twice daily doses, completed the maintenance period (n=10), and enrolled in the post-maintenance extension period (n=6).
  • Maintenance period:
    • 56% median seizure reduction from baseline.
    • 70% of subjects had 30% or more seizure reduction.
    • 60% of subjects had 50% or more seizure reduction.
    • 30% of subjects had 75% or more seizure reduction.
  • Post-maintenance extension period:
    • 66% median seizure reduction from baseline.
    • 83% of subjects had 30% or more seizure reduction.
    • 67% of subjects had 50% or more seizure reduction.
    • 50% of subjects had 75% or more seizure reduction.
  • Seizure Freedom:
    • Maintenance period: 1 out of 10 subjects (10%) who completed a post-baseline seizure diary had at least one four-week seizure free period.
    • Post-maintenance extension period: 1 out of 6 subjects (17%) had at least one four-week seizure free period.
  • Assessment by EpiTrack®, a validated cognitive screening tool designed for patients with epilepsy, indicated that 75% of 16 subjects was equally split between those who improved and those who had no change in cognitive function.
  • SPN-817 was safe and had acceptable tolerability with 2 subjects discontinuing because of treatment related adverse events out of the 26 subjects who entered the maintenance period. Stage B of the study is on-going and includes the concomitant use of an anti-emetic to reduce cholinergic adverse events observed in the study.
  • A Phase 2b randomized, double-blind, placebo-controlled study in patients with treatment resistant focal seizures is expected to start by the end of 2024 studying 3mg and 4mg twice daily doses.

SPN-443 – Novel stimulant for ADHD/CNS

  • The Company initiated a Phase 1 single dose study in healthy adults in the third quarter of 2024. The primary objective of the study is to assess safety and tolerability.

Financial Highlights

This section includes information on non-GAAP financial measures. See “Non-GAAP Financial Information” section for information on non-GAAP financial measures. In addition, a reconciliation of applicable GAAP to non-GAAP financial information is included at the end of this press release.

Revenues

The following table provides information regarding total revenues (dollars in millions):

  Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
    2024     2023   Change %     2024     2023   Change %
Net product sales                      
Qelbree $ 62.4   $ 37.1   68%   $ 166.9   $ 93.8   78%
GOCOVRI   35.6     32.9   8%     93.9     87.7   7%
Oxtellar XR   29.8     29.6   1%     86.3     82.4   5%
APOKYN   19.9     21.5   (8)%     53.8     56.3   (4)%
Trokendi XR   15.3     20.6   (26)%     48.4     74.7   (35)%
Other(3)   7.3     7.3   —%     22.0     23.0   (4)%
Total net product sales $ 170.3   $ 149.0   14%   $ 471.3   $ 417.9   13%
Royalty, licensing and other revenues(4)   5.4     4.9   10%     16.4     25.3   (35)%
Total revenues $ 175.7   $ 153.9   14%   $ 487.7   $ 443.2   10%
                       
Total revenues excluding Trokendi XR and Oxtellar XR net product sales (non-GAAP)(1) $ 130.6   $ 103.7   26%   $ 353.0   $ 286.1   23%
                               
  • Total revenues were $175.7 million and $487.7 million for the three and nine months ended September 30, 2024, compared to $153.9 million and $443.2 million in the same periods in 2023, respectively.
    • Total net product sales were $170.3 million and $471.3 million for the three and nine months ended September 30, 2024, compared to $149.0 million and $417.9 million in the same periods in 2023, respectively. The increase in both periods was primarily due to the increase in net sales of Qelbree and GOCOVRI, partially offset by the decline in net product sales of Trokendi XR due to generic erosion.
    • Total revenues excluding Trokendi XR and Oxtellar XR net product sales (non-GAAP) increased 26% and 23% for the three and nine months ended September 30, 2024, compared to the same periods in 2023, respectively.

Other Financial Highlights

  • Operating earnings were $40.9 million and $60.3 million for the three and nine months ended September 30, 2024, compared to operating earnings (loss) of $8.1 million and $(4.3) million for the same periods in 2023, respectively. The positive increase in both periods was primarily due to an increase in total net product sales and decreases in cost of goods sold and selling, general and administrative expenses.
  • Adjusted operating earnings (non-GAAP) were $67.7 million and $135.4 million for the three and nine months ended September 30, 2024, compared to $37.3 million and $77.9 million for the same periods in 2023, respectively.
  • Net earnings and diluted earnings per share were $38.5 million and $0.69 for the three months and $58.5 million and $1.05 for the nine months ended September 30, 2024, respectively, compared to net earnings (loss) and diluted earnings (loss) per share of $(16.0) million and $(0.29) for the three months and $0.1 million and $0.00 for the nine months ended September 30, 2023, respectively.
  • At September 30, 2024, cash, cash equivalents, and current and long-term marketable securities were approximately $403.2 million compared to $271.5 million as of December 31, 2023. This increase was primarily due to cash generated from operations.

Full Year 2024 Financial Guidance

For the full year 2024, the Company is increasing prior financial guidance for total revenues and operating earnings (GAAP and Non-GAAP) as set forth below (dollars in millions):

  Current Guidance
(as of November 4, 2024)
  Previous Guidance
(as of August 6, 2024)
Total revenues (includes approximately $155 million of Trokendi XR and Oxtellar XR)(5)(6) $630 - $650   $600 - $625
Combined R&D and SG&A expenses $430 - $450   $430 - $460
Operating earnings $50 - $65   $0 - $20
Adjusted operating earnings (non-GAAP)(1) $150 - $170   $100 - $125


Non-GAAP Financial Information

This press release contains financial measures that present financial information which do not comply with United States generally accepted accounting principles (GAAP). The non-GAAP financial measures should be considered in addition to, not as a substitute for or in isolation from, or superior to measures prepared in accordance with GAAP. Non-GAAP adjusted operating earnings on a historical and projected basis adjusts for non-cash share-based compensation expense, depreciation and amortization, intangible asset impairment charges and changes to fair value of contingent consideration, and for factors that are unusual, non-recurring or unpredictable, and excludes those costs, expenses, and other specified items presented in the reconciliation tables in this press release. In addition to non-GAAP adjusted operating earnings, we also present total revenues excluding net product sales of Trokendi XR (GAAP) and Oxtellar XR (GAAP), which is a non-GAAP measure and is calculated as total revenues (GAAP) less net product sales of Trokendi XR (GAAP) and Oxtellar XR (GAAP). Beginning in the year a product loses exclusivity due to generic entrants we generally do not expect net product sales of such products to constitute a significant part of our revenue in the future. We believe that the use of non-GAAP financial measures provides useful supplemental information to management, investors, analysts and others regarding the Company’s revenue and results of operations and assist management, investors, analysts, and others in understanding and evaluating our revenue growth and the performance of the business.

There are limitations associated with the use of non-GAAP financial measures and therefore comparability may be limited. These limitations include: non-GAAP financial measures that may not be entirely comparable to similarly titled measures used by other companies; these may not reflect all items of income and expense, as applicable, that affect our operations; there may be potential differences among calculation methodologies; these may differ from the non-GAAP information used by other companies, including peer companies. We mitigate these limitations by reconciling the non-GAAP financial measure to the most comparable GAAP financial measure. Investors are encouraged to review the reconciliation. The Company’s 2024 financial guidance is also being provided on both a GAAP and a non-GAAP basis.

End Notes    

(1) See the section titled “Non-GAAP Financial Information” for information about this non-GAAP financial measure. A reconciliation of each non-GAAP financial measure to the most directly comparable GAAP financial measure is included at the end of this press release.
(2) IQVIA data restatement July 1, 2024.
(3) Includes net product sales of MYOBLOC®, XADAGO® and Osmolex ER®.
(4) Royalty, licensing, and other revenues include royalties on generic Trokendi XR, other licensed products and intellectual property.
(5) Includes net product sales and royalty, licensing, and other revenue.
(6) Reflects continued generic erosion of Trokendi XR and generic erosion of Oxtellar XR beginning in September 2024.

Conference Call Details

Supernus will host a conference call and webcast today, November 4, 2024, at 4:30 p.m. Eastern Time to discuss these results. A live webcast will be available in the Events & Presentations section of the Company’s Investor Relations website www.supernus.com/Investors.

Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.

Following the live call, a replay will be available on the Company's Investor Relations website www.supernus.com/Investors. The webcast will be available on the Company’s website for 60 days following the live call.

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 (PD), cervical dystonia, chronic sialorrhea, and dyskinesia in PD patients receiving levodopa-based therapy. We are developing a broad range of novel CNS product candidates including new potential treatments for hypomobility in PD, epilepsy, depression, and other 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 and the products of its subsidiaries; the Company’s ability to increase its net revenue from its products and the products of its subsidiaries; the Company’s ability to commercialize its products and the products of its subsidiaries; 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 the intellectual property of its subsidiaries 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,
    2024     2023  
  (unaudited)    
Assets      
Current assets      
Cash and cash equivalents $ 31,673   $ 75,054  
Marketable securities   371,537     179,820  
Accounts receivable, net   145,408     144,155  
Inventories, net   63,981     77,408  
Prepaid expenses and other current assets   27,404     16,676  
Total current assets   640,003     493,113  
Long-term marketable securities       16,617  
Property and equipment, net   11,876     13,530  
Intangible assets, net   540,156     599,889  
Goodwill   117,019     117,019  
Other assets   33,647     37,505  
Total assets $ 1,342,701   $ 1,277,673  
       
Liabilities and stockholders’ equity      
Current liabilities      
Accounts payable and accrued liabilities $ 75,803   $ 79,569  
Accrued product returns and rebates   169,124     154,274  
Contingent consideration, current portion   46,581     52,070  
Other current liabilities       4,283  
Total current liabilities   291,508     290,196  
Contingent consideration, long-term   403     1,380  
Operating lease liabilities, long-term   28,926     33,196  
Deferred income tax liabilities, net   7,364     24,963  
Other liabilities   7,350     6,422  
Total liabilities   335,551     356,157  
       
Stockholders’ equity      
Common stock, $0.001 par value; 130,000,000 shares authorized; 55,219,273 and 54,723,356 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively   55     55  
Additional paid-in capital   465,919     439,493  
Accumulated other comprehensive earnings (loss), net of tax   78     (593 )
Retained earnings   541,098     482,561  
Total stockholders’ equity   1,007,150     921,516  
       
Total liabilities and stockholders’ equity $ 1,342,701   $ 1,277,673  

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

  Three Months Ended
September 30,
  Nine Months Ended
September 30,
    2024       2023       2024       2023  
  (unaudited)   (unaudited)
Revenues              
Net product sales $ 170,302     $ 149,004     $ 471,301     $ 417,915  
Royalty, licensing and other revenues   5,387       4,876       16,357       25,292  
Total revenues   175,689       153,880       487,658       443,207  
               
Costs and expenses              
Cost of goods sold(a)   17,583       19,601       51,808       64,152  
Research and development   29,036       22,655       80,149       68,246  
Selling, general and administrative   69,753       82,700       242,173       255,079  
Amortization of intangible assets   19,488       21,242       59,733       61,316  
Contingent consideration gain   (1,016 )     (456 )     (6,466 )     (1,313 )
Total costs and expenses   134,844       145,742       427,397       447,480  
               
Operating earnings (loss)   40,845       8,138       60,261       (4,273 )
               
Other income (expense)              
Interest and other income, net   4,098       1,751       11,227       8,467  
Interest expense                     (2,415 )
Total other income (expense)   4,098       1,751       11,227       6,052  
               
Earnings before income taxes   44,943       9,889       71,488       1,779  
               
Income tax expense   6,446       25,865       12,951       1,638  
Net earnings (loss) $ 38,497     $ (15,976 )   $ 58,537     $ 141  
               
Earnings (loss) per share              
Basic $ 0.70     $ (0.29 )   $ 1.06     $  
Diluted $ 0.69     $ (0.29 )   $ 1.05     $  
               
Weighted average shares outstanding              
Basic   55,149,760       54,608,963       54,977,199       54,498,687  
Diluted   56,016,350       54,608,963       55,791,185       55,574,922  

_________________
(a) Excludes amortization of intangible assets.

Supernus Pharmaceuticals, Inc.
Reconciliations of GAAP to Non-GAAP Financial Information
(Unaudited)

Reconciliation of GAAP Total revenues to Non-GAAP Total revenues excluding Trokendi XR and Oxtellar XR net product sales

An itemized reconciliation between total revenues on a GAAP basis and Total revenues excluding Trokendi XR and Oxtellar XR net product sales, a non-GAAP measure, is as follows (dollars in millions):

  Three Months Ended
September 30,
      Nine Months Ended
September 30,
   
    2024       2023     Change %     2024       2023     Change %
Total revenues (GAAP)(1) $ 175.7     $ 153.9     14%   $ 487.7     $ 443.2     10%
Adjustments:                      
Trokendi XR net product sales   (15.3 )     (20.6 )   (26)%     (48.4 )     (74.7 )   (35)%
Oxtellar XR net product sales   (29.8 )     (29.6 )   1%     (86.3 )     (82.4 )   5%
Total revenues excluding Trokendi XR and Oxtellar XR net product sales (non-GAAP)(1) $ 130.6     $ 103.7     26%   $ 353.0     $ 286.1     23%

____________
(1) Includes net product sales and royalty, licensing, and other revenues.

Reconciliation of GAAP Operating earnings (loss) to Non-GAAP Adjusted Operating earnings

An itemized reconciliation between operating earnings (loss) on a GAAP basis and adjusted operating earnings on a non-GAAP basis is as follows (dollars in millions):

  Three Months Ended
September 30,
  Nine Months Ended
September 30,
    2024       2023       2024       2023  
Operating earnings (loss) - As Reported (GAAP) $ 40.9     $ 8.1     $ 60.3       (4.3 )
Adjustments:              
Amortization of intangible assets   19.5       21.2       59.7       61.3  
Share-based compensation   7.7       7.9       20.1       20.3  
Contingent consideration gain   (1.0 )     (0.5 )     (6.5 )     (1.3 )
Depreciation   0.6       0.6       1.8       1.9  
Operating earnings - As Adjusted (non-GAAP) $ 67.7     $ 37.3     $ 135.4     $ 77.9  

Non-GAAP adjusted operating earnings adjusts for non-cash items including amortization of intangible assets, share-based compensation expense, change in fair value of contingent consideration, and depreciation.

Reconciliation of Full Year 2024 Financial Guidance - GAAP Operating earnings (loss) to Non-GAAP Adjusted Operating earnings

An itemized reconciliation between projected operating earnings (loss) on a GAAP basis for the full year 2024 and projected adjusted operating earnings on a non-GAAP basis for the full year 2024 is as follows (dollars in millions):

  Current Guidance
(as of November 4, 2024)
  Previous Guidance
(as of August 6, 2024)
Operating earnings (loss) - GAAP $50 - $65   $0 - $20
Adjustments:      
Amortization of intangible assets $78 - $80   $78 - $80
Share-based compensation $27 - $29   $27 - $29
Contingent consideration gain $(7) - $(7)   $(7) - $(7)
Depreciation $2 - $3   $2 - $3
Operating earnings - As Adjusted (non-GAAP) $150 - $170   $100 - $125


CONTACTS:

Jack A. Khattar, President and CEO
Timothy C. Dec, Senior Vice President and CFO
Supernus Pharmaceuticals, Inc.
(301) 838-2591

or

INVESTOR CONTACT:
Peter Vozzo
ICR Westwicke
(443) 213-0505
peter.vozzo@westwicke.com