Supernus Announces Third Quarter 2023 Financial Results
- Raises full year 2023 adjusted operating earnings (non-GAAP)(1) guidance range to
$95 million to$110 million from previous range of$75 million to$100 million - Total revenues (GAAP) of
$153.9 million in the third quarter of 2023; total revenues excluding Trokendi XR® net product sales (non-GAAP)(2), increased by 24% in the third quarter of 2023, compared to the same period in 2022 - Qelbree® net product sales of
$37.1 million in the third quarter of 2023, a 103% increase compared to the third quarter of 2022 and a 20% increase compared to the second quarter of 2023 - GOCOVRI® net product sales of
$32.9 million in the third quarter of 2023, an 18% increase compared to the third quarter of 2022 and a 14% increase compared to the second quarter of 2023 - Operating earnings (GAAP) of
$8.1 million in the third quarter of 2023, compared to an operating loss (GAAP) of($1.5) million in the third quarter of 2022 - Adjusted operating earnings (non-GAAP) of
$37.3 million in the third quarter of 2023, an increase of 47% compared to the third quarter of 2022 - SPN-830 (apomorphine infusion device) NDA resubmission accepted for review by FDA; PDUFA date of
April 5, 2024
“Our third-quarter performance underscores the strength of our growth products, with combined Qelbree and GOCOVRI net product sales increasing 52% in the third quarter of 2023 compared to the same period last year,” said
Qelbree Update
- Total
IQVIA prescriptions were 163,344 in the third quarter of 2023, an increase of 73% compared to the same period last year and 12% compared to the second quarter of 2023. - Qelbree continues to expand its base of prescribers, with approximately 24,189 prescribers in the third quarter of 2023, up from 21,291 prescribers in the second quarter of 2023.
- The Company presented new data at
Psych Congress 2023 in September showing improved efficacy in children ages 6 years and older with attention-deficit hyperactivity disorder (ADHD) when Qelbree is administered with stimulants, as well as in adults with ADHD who undergo long-term treatment with Qelbree.
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(1) Adjusted Operating Earnings is a non-GAAP measure and is calculated as Operating Earnings (Loss) (GAAP) plus amortization of intangible assets, share-based compensation, contingent consideration expense (gain) and depreciation. A reconciliation of the full year 2023 financial guidance for Operating Loss (GAAP) to Adjusted Operating Earnings (non-GAAP) is included under the heading “Full Year 2023 Financial Guidance – GAAP to Non-GAAP Adjustments.”
(2) Total revenues, excluding Trokendi XR net product sales is a non-GAAP measure and is calculated as total revenues (GAAP) less net product sales of Trokendi XR (GAAP). A reconciliation of this measure to Total revenues (GAAP) is included under the heading “Reconciliation of GAAP Total revenues to Non-GAAP Total revenues excluding Trokendi XR net product sales.”
Product Pipeline Update
The Company hosted a successful Research & Development (R&D) Day in
SPN-830 (apomorphine infusion device) for treatment of PD
- In
November 2023 , the FDA accepted the resubmission of the New Drug Application (NDA) for SPN-830 for continuous treatment of motor fluctuations ("off" episodes) in Parkinson's disease (PD). The resubmission is now considered filed, with a user fee goal date (PDUFA date) ofApril 5, 2024 .
SPN-820 – Novel first-in-class molecule that increases mTORC1 mediated synaptic function for depression
- The Phase IIb multi-center randomized double-blind placebo-controlled parallel design study of SPN-820 in adults with treatment-resistant depression is ongoing. The study will examine the efficacy and safety of SPN-820 over a course of five weeks of treatment in approximately 268 patients in up to 50 clinical sites. The primary outcome measure is the change from baseline to end of treatment period on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. Topline data from the Phase IIb trial is expected in 2025.
- The Company plans to initiate a Phase II open-label study in approximately 40 subjects with major depressive disorder (MDD) before year-end 2023. The primary objective of the study is to assess efficacy in MDD, as well as onset of efficacy.
SPN-817 – Novel first-in-class highly selective AChE inhibitor for epilepsy
- An open-label Phase IIa clinical study of SPN-817 for treatment-resistant seizures is ongoing. The study is examining the safety and tolerability of SPN-817 as adjunctive therapy in adult patients with treatment-resistant seizures, as well as assessing efficacy. The Company expects topline results from the Phase IIa study in the first half of 2024.
- The Company expects to initiate a Phase IIb randomized, double-blind, placebo-controlled study in approximately 436 patients with treatment-resistant focal seizures in the first half of 2024. The primary endpoint is change from baseline in focal seizure frequency per 28 days. Topline results from the Phase IIb study are expected in 2026.
SPN-443 – Novel stimulant for ADHD/CNS
- The Company is planning in 2024 to initiate a Phase I single dose study in approximately 24 healthy adults following submission of an Investigational New Drug (IND) application. The primary objective of the study is to assess safety and tolerability.
Financial Highlights
Total revenues (GAAP and non-GAAP)
For the three months ended
Total revenues excluding Trokendi XR net product sales (non-GAAP) for the three and nine months ended
The following table provides information regarding total revenues during the three and nine months ended
| Three Months Ended |
Nine Months Ended |
||||||||||||||||
| 2023 | 2022 | Change % | 2023 | 2022 | Change % | ||||||||||||
| Total net product sales | $ | 149.0 | $ | 172.7 | (14 | )% | $ | 417.9 | $ | 485.6 | (14 | )% | |||||
| Royalty revenues(1) | 4.9 | 4.7 | 4 | % | 25.3 | 14.3 | 77 | % | |||||||||
| Total revenues (GAAP) | $ | 153.9 | $ | 177.4 | (13 | )% | $ | 443.2 | $ | 499.9 | (11 | )% | |||||
| Total revenues excluding Trokendi XR net product sales (non-GAAP) | $ | 133.3 | $ | 107.8 | 24 | % | $ | 368.5 | $ | 295.9 | 25 | % | |||||
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(1) Royalty revenues include royalties on generic Trokendi XR, other licensed products and intellectual property.
The following table provides information regarding total net product sales during the three and nine months ended
| Three Months Ended |
Nine Months Ended |
||||||||||||||||
| 2023 | 2022 | Change % | 2023 | 2022 | Change % | ||||||||||||
| Net product sales | |||||||||||||||||
| Qelbree | $ | 37.1 | $ | 18.3 | 103 | % | $ | 93.8 | $ | 37.7 | 149 | % | |||||
| GOCOVRI | 32.9 | 27.9 | 18 | % | 87.7 | 75.2 | 17 | % | |||||||||
| Oxtellar XR® | 29.6 | 30.5 | (3 | )% | 82.4 | 88.0 | (6 | )% | |||||||||
| Trokendi XR | 20.6 | 69.6 | (70 | )% | 74.7 | 204.0 | (63 | )% | |||||||||
| APOKYN® | 21.5 | 18.3 | 17 | % | 56.3 | 57.2 | (2 | )% | |||||||||
| Other(1) | 7.3 | 8.1 | (10 | )% | 23.0 | 23.5 | (2 | )% | |||||||||
| Total net product sales | $ | 149.0 | $ | 172.7 | (14 | )% | $ | 417.9 | $ | 485.6 | (14 | )% | |||||
___________________________________________
(1) Includes net product sales of MYOBLOC®, XADAGO® and Osmolex ER®.
Operating earnings (loss) (GAAP and non-GAAP)
For the three months ended
For the three months ended
Reconciliation of GAAP Operating earnings (loss) to Non-GAAP Operating earnings
An itemized reconciliation between operating earnings (loss) on a GAAP basis and operating earnings on a non-GAAP basis is as follows (unaudited, dollars in millions):
| Three Months Ended |
Nine Months Ended |
|||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||
| Operating earnings (loss) - As Reported (GAAP) | $ | 8.1 | $ | (1.5 | ) | $ | (4.3 | ) | $ | 11.8 | ||||
| Adjustments: | ||||||||||||||
| Amortization of intangible assets | 21.2 | 20.6 | 61.3 | 61.9 | ||||||||||
| Share-based compensation | 7.9 | 5.0 | 20.3 | 13.3 | ||||||||||
| Contingent consideration expense (gain) | (0.5 | ) | 0.5 | (1.3 | ) | 1.9 | ||||||||
| Depreciation | 0.6 | 0.8 | 1.9 | 2.2 | ||||||||||
| Operating earnings - As Adjusted (non-GAAP) | $ | 37.3 | $ | 25.4 | $ | 77.9 | $ | 91.1 | ||||||
Non-GAAP 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.
Net earnings (loss) (GAAP)
For the three months ended
Balance sheet
At
Full Year 2023 Financial Guidance (GAAP)
The Company is revising its full-year 2023 financial guidance as set forth below (dollars in millions).
| Current (as of |
Previous (as of |
||
| Total revenues(1)(2) | |||
| Combined R&D and SG&A expenses | |||
| Operating loss(3) | ( |
( |
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(1) Includes net product sales and royalty revenue, and approximately
(2) Reflects Trokendi XR generic erosion in 2023.
(3) Includes amortization of intangible assets and contingent consideration expense (gain).
Full Year 2023 Financial Guidance - GAAP to Non-GAAP Adjustments
An itemized reconciliation between projected operating loss on a GAAP basis and projected operating earnings on a non-GAAP basis is as follows (dollars in millions):
| Current (as of |
Previous (as of |
||||
| Operating loss - GAAP | ( |
( |
|||
| Adjustments: | |||||
| Amortization of intangible assets | |||||
| Share-based compensation | |||||
| Contingent consideration | |||||
| Depreciation | |||||
| Operating earnings - non-GAAP | |||||
Non-GAAP Financial Information
This press release contains financial measures that present financial information which do not comply with
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 2023 financial guidance is also being provided on both a reported and a non-GAAP basis.
Reconciliation of GAAP Total revenues to Non-GAAP Total revenues excluding Trokendi XR net product sales
An itemized reconciliation between total revenues on a GAAP basis and Total revenues excluding Trokendi XR net product sales, a non-GAAP measure, is as follows (unaudited, dollars in millions):
| Three Months Ended |
Nine Months Ended |
||||||||||||||||
| 2023 | 2022 | Change % | 2023 | 2022 | Change % | ||||||||||||
| Total revenues (GAAP)(1) | (13 | )% | (11 | )% | |||||||||||||
| Less: Trokendi XR net product sales | 20.6 | 69.6 | (70 | )% | 74.7 | 204.0 | (63 | )% | |||||||||
| Total revenues excluding Trokendi XR net product sales (Non-GAAP) | 24 | % | 25 | % | |||||||||||||
___________________________________________
(1) Includes net product sales and royalty revenue.
Conference Call Details
Supernus will host a conference call and webcast today,
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 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
Our diverse neuroscience portfolio includes approved treatments for epilepsy, migraine, ADHD, hypomobility in PD, cervical dystonia, chronic sialorrhea, dyskinesia in PD patients receiving levodopa-based therapy, and drug-induced extrapyramidal reactions in adult patients. 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; 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; 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; and other risk factors set forth from time to time in the Company’s filings with the
Consolidated Balance Sheets (in thousands, except share data) |
|||||||
| 2023 | 2022 | ||||||
| (unaudited) | |||||||
| Assets | |||||||
| Current assets | |||||||
| Cash and cash equivalents | $ | 94,985 | $ | 93,120 | |||
| Marketable securities | 105,204 | 368,214 | |||||
| Accounts receivable, net | 141,764 | 165,497 | |||||
| Inventories, net | 83,480 | 91,541 | |||||
| Prepaid expenses and other current assets | 23,927 | 15,779 | |||||
| Total current assets | 449,360 | 734,151 | |||||
| Long-term marketable securities | 25,125 | 93,896 | |||||
| Property and equipment, net | 13,688 | 15,173 | |||||
| Intangible assets, net | 641,147 | 702,463 | |||||
| 117,019 | 117,019 | ||||||
| Other assets | 38,821 | 39,806 | |||||
| Total assets | $ | 1,285,160 | $ | 1,702,508 | |||
| Liabilities and stockholders’ equity | |||||||
| Current liabilities | |||||||
| Accounts payable and accrued liabilities | $ | 78,471 | $ | 96,342 | |||
| Accrued product returns and rebates | 162,473 | 151,665 | |||||
| Convertible notes, net | — | 401,968 | |||||
| Contingent consideration, current portion | 45,880 | 21,120 | |||||
| Other current liabilities | 710 | 16,863 | |||||
| Total current liabilities | 287,534 | 687,958 | |||||
| Contingent consideration, long-term | 7,774 | 33,847 | |||||
| Operating lease liabilities, long-term | 33,841 | 35,998 | |||||
| Deferred income tax liabilities, net | 35,224 | 49,809 | |||||
| Other liabilities | 8,596 | 8,692 | |||||
| Total liabilities | 372,969 | 816,304 | |||||
| Stockholders’ equity | |||||||
| Common stock, |
55 | 54 | |||||
| Additional paid-in capital | 431,956 | 408,115 | |||||
| Accumulated other comprehensive loss, net of tax | (1,206 | ) | (3,210 | ) | |||
| Retained earnings | 481,386 | 481,245 | |||||
| Total stockholders’ equity | 912,191 | 886,204 | |||||
| Total liabilities and stockholders’ equity | $ | 1,285,160 | $ | 1,702,508 | |||
Consolidated Statements of Earnings (Loss) (in thousands, except share and per share data) |
|||||||||||||||
| Three Months Ended |
Nine Months Ended |
||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||
| (unaudited) | (unaudited) | ||||||||||||||
| Revenues | |||||||||||||||
| Net product sales | $ | 149,004 | $ | 172,724 | $ | 417,915 | $ | 485,647 | |||||||
| Royalty revenues | 4,876 | 4,629 | 25,292 | 14,263 | |||||||||||
| Total revenues | 153,880 | 177,353 | 443,207 | 499,910 | |||||||||||
| Costs and expenses | |||||||||||||||
| Cost of goods sold | 19,601 | 25,878 | 64,152 | 64,267 | |||||||||||
| Research and development | 22,655 | 19,554 | 68,246 | 56,778 | |||||||||||
| Selling, general and administrative | 82,700 | 112,314 | 255,079 | 303,249 | |||||||||||
| Amortization of intangible assets | 21,242 | 20,644 | 61,316 | 61,932 | |||||||||||
| Contingent consideration expense (gain) | (456 | ) | 486 | (1,313 | ) | 1,894 | |||||||||
| Total costs and expenses | 145,742 | 178,876 | 447,480 | 488,120 | |||||||||||
| Operating earnings (loss) | 8,138 | (1,523 | ) | (4,273 | ) | 11,790 | |||||||||
| Other income (expense) | |||||||||||||||
| Interest expense | — | (1,724 | ) | (2,415 | ) | (5,476 | ) | ||||||||
| Interest and other income, net | 1,751 | 2,803 | 8,467 | 19,289 | |||||||||||
| Total other income (expense) | 1,751 | 1,079 | 6,052 | 13,813 | |||||||||||
| Earnings (loss) before income taxes | 9,889 | (444 | ) | 1,779 | 25,603 | ||||||||||
| Income tax expense (benefit) | 25,865 | (2,193 | ) | 1,638 | (9,627 | ) | |||||||||
| Net earnings (loss) | $ | (15,976 | ) | $ | 1,749 | $ | 141 | $ | 35,230 | ||||||
| Earnings (loss) per share | |||||||||||||||
| Basic | $ | (0.29 | ) | $ | 0.03 | $ | 0.00 | $ | 0.66 | ||||||
| Diluted | $ | (0.29 | ) | $ | 0.03 | $ | 0.00 | $ | 0.62 | ||||||
| Weighted average shares outstanding | |||||||||||||||
| Basic | 54,608,963 | 53,789,674 | 54,498,687 | 53,517,838 | |||||||||||
| Diluted | 54,608,963 | 55,034,838 | 55,574,922 | 61,543,121 | |||||||||||
CONTACTS:
Tel: (301) 838-2591
or
INVESTOR CONTACT:
ICR Westwicke
Office: (443) 213-0505
Email: peter.vozzo@westwicke.com
Source: Supernus Pharmaceuticals, Inc.