ROCKVILLE, Md., Nov. 08, 2023 (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 2023, and associated Company developments.
“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 Jack Khattar, President and CEO of Supernus. “In addition to our strong commercial execution, during our R&D Day in October 2023, we highlighted our pipeline of first-in-class differentiated CNS product candidates that have the potential to bolster future growth.”
Qelbree Update
(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 October 2023 highlighting clinical and R&D progress and its emerging pipeline of novel CNS product candidates. During the R&D Day the Company provided a product pipeline update as set forth below:
SPN-830 (apomorphine infusion device) for treatment of PD
SPN-820 – Novel first-in-class molecule that increases mTORC1 mediated synaptic function for depression
SPN-817 – Novel first-in-class highly selective AChE inhibitor for epilepsy
SPN-443 – Novel stimulant for ADHD/CNS
Financial Highlights
Total revenues (GAAP and non-GAAP)
For the three months ended September 30, 2023, total revenues and total net product sales (GAAP) were $153.9 million and $149.0 million, respectively, compared to total revenues and total net product sales of $177.4 million and $172.7 million for the same period in 2022. For the nine months ended September 30, 2023, total revenues and total net product sales were $443.2 million and $417.9 million, respectively, compared to total revenues and total net product sales of $499.9 million and $485.6 million for the same period in 2022. The decrease in net product sales in both periods was primarily due to the decline in net product sales of Trokendi XR. This decline in net product sales of Trokendi XR was partially offset by an increase in net product sales of Qelbree, GOCOVRI and APOKYN for the three months ended September 30, 2023, and an increase in net product sales of Qelbree and GOCOVRI for the nine months ended September 30, 2023.
Total revenues excluding Trokendi XR net product sales (non-GAAP) for the three and nine months ended September 30, 2023, increased 24% and 25%, respectively, compared to the same periods in 2022.
The following table provides information regarding total revenues during the three and nine months ended September 30, 2023 and 2022 (unaudited, dollars in millions):
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||
| 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 | % | |||||
___________________________________________
(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 September 30, 2023 and 2022 (unaudited, dollars in millions):
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||
| 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 September 30, 2023, operating earnings (GAAP) was $8.1 million, compared to operating loss (GAAP) of ($1.5) million for the same period in 2022. For the nine months ended September 30, 2023, operating loss (GAAP) was ($4.3) million, compared to operating earnings (GAAP) of $11.8 million for the same period in 2022. The increase in operating earnings (GAAP) in the third quarter of 2023 was due primarily to lower selling and marketing expenses compared to the third quarter of 2022 due to the launch of Qelbree to the adult population and the Qelbree direct-to-consumer campaign, which substantially occurred in the third quarter of 2022. The operating loss (GAAP) in the nine months ended September 30, 2023 was primarily due to a decrease in net product sales of Trokendi XR, partially offset by growth in net product sales of Qelbree and GOCOVRI, and a decrease in operating expenses.
For the three months ended September 30, 2023, adjusted operating earnings (non-GAAP) were $37.3 million, compared to $25.4 million for the same period in 2022. For the nine months ended September 30, 2023, adjusted operating earnings (non-GAAP) were $77.9 million, compared to $91.1 million for the same period in 2022.
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 September 30, | Nine Months Ended September 30, | |||||||||||||
| 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 September 30, 2023, net earnings (loss) (GAAP) and diluted earnings (loss) per share (GAAP) were ($16.0) million and ($0.29), respectively, as compared to $1.7 million and $0.03, in the same period in 2022. For the nine months ended September 30, 2023, net earnings (GAAP) and diluted earnings per share (GAAP) were $0.1 million and $0.00, respectively, as compared to $35.2 million and $0.62 in the same period in 2022.
Balance sheet
At September 30, 2023, the Company's cash, cash equivalents, and current and long-term marketable securities were approximately $225.3 million, compared to $555.2 million as of December 31, 2022. This decrease was primarily due to repayment of the Company's $402.5 million 0.625% Convertible Senior Notes due 2023 (2023 Notes), partially offset by cash generated from operations.
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 November 8, 2023) | Previous (as of August 8, 2023) | ||
| Total revenues(1)(2) | $590 - $610 | $580 - $620 | |
| Combined R&D and SG&A expenses | $420 - $440 | $450 - $480 | |
| Operating loss(3) | ($15) - ($5) | ($30) - ($10) |
___________________________________________
(1) Includes net product sales and royalty revenue, and approximately $90 million of Trokendi XR.
(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 November 8, 2023) | Previous (as of August 8, 2023) | ||||
| Operating loss - GAAP | ($15) - ($5) | ($30) - ($10) | |||
| Adjustments: | |||||
| Amortization of intangible assets | $83 | $83 | |||
| Share-based compensation | $25 - $29 | $20 - $24 | |||
| Contingent consideration | $0 - $1 | $0 - $1 | |||
| Depreciation | $2 | $2 | |||
| Operating earnings - non-GAAP | $95 - $110 | $75 - $100 | |||
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 measure 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 operating earnings adjusts for non-cash share-based compensation expense, depreciation and amortization, and accretion 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 operating earnings, we also present total revenues excluding net product sales of Trokendi XR which is a non-GAAP measure and is calculated as total revenues (GAAP) less net product sales of Trokendi XR (GAAP). With the loss of exclusivity due to generic entrants, we do not expect net product sales of Trokendi XR 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 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 September 30, | Nine Months Ended September 30, | ||||||||||||||||
| 2023 | 2022 | Change % | 2023 | 2022 | Change % | ||||||||||||
| Total revenues (GAAP)(1) | $153.9 | $177.4 | (13 | )% | $443.2 | $499.9 | (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) | $133.3 | $107.8 | 24 | % | $368.5 | $295.9 | 25 | % | |||||||||
___________________________________________
(1) Includes net product sales and royalty revenue.
Conference Call Details
Supernus will host a conference call and webcast today, November 8, 2023, 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 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 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 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. Consolidated Balance Sheets (in thousands, except share data) | |||||||
| September 30, | December 31, | ||||||
| 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 | |||||
| Goodwill | 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, $0.001 par value; 130,000,000 shares authorized; 54,630,758 and 54,253,796 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively | 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 | |||
| Supernus Pharmaceuticals, Inc. Consolidated Statements of Earnings (Loss) (in thousands, except share and per share data) | |||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| 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:
Jack A. Khattar, President and CEO
Timothy C. Dec, Senior Vice President and CFO
Supernus Pharmaceuticals, Inc.
Tel: (301) 838-2591
or
INVESTOR CONTACT:
Peter Vozzo
ICR Westwicke
Office: (443) 213-0505
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
| Last Trade: | US$35.57 |
| Daily Change: | -0.61 -1.69 |
| Daily Volume: | 328,463 |
| Market Cap: | US$1.960B |
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