Supernus Announces Fourth Quarter and Full Year 2020 Financial Results
02/25/2021 - 04:00 PM
Full year 2020 total revenues of $520.4 million , a 32% increase compared to 2019 Full year 2020 operating earnings of $173.7 million , a 17% increase compared to 2019 SPN-812 NDA assigned an early April 2021 PDUFA date Positive results from Phase III study for SPN-812 in adults with ADHD announced in December 2020 Full year 2021 total revenues guidance of $550 million to $580 million ROCKVILLE, Md., Feb. 25, 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 fourth quarter and full year of 2020, and associated Company developments.
“We reported record revenues and operating earnings in 2020 based on the growth of Trokendi XR and Oxtellar XR and the addition of the CNS products acquired during the year,” said Jack Khattar, President and CEO of Supernus Pharmaceuticals. “Looking ahead, we are preparing for the expected launch of SPN-812 in the second quarter of 2021 and are excited to bring a novel non-stimulant treatment option to the millions of children and adolescents across the U.S. with ADHD.”
Commercial Update
Fourth quarter 2020 net product sales were $140.7 million , 44% higher than the same period in 2019, driven by the addition of $39.5 million of net product sales from the commercial products acquired in 2020 and $3.3 million in net product sales growth from Trokendi XR and Oxtellar XR. Full year 2020 net product sales were $509.3 million , 33% higher than full year 2019, driven by the addition of $91.0 million of net product sales from the commercial products acquired in 2020 and $34.9 million in net product sales growth from Trokendi XR and Oxtellar XR.
Net Product Sales ($ in millions) Q4 2020 Q4 2019 Change % FY 2020 FY 2019 Change % Trokendi XR $ 78.5 $ 75.2 4 % $ 319.6 $ 295.2 8 % Oxtellar XR 22.7 22.7 — % 98.7 88.2 12 % APOKYN 31.2 — ** 74.3 — ** MYOBLOC 4.5 — ** 9.8 — ** XADAGO 3.8 — ** 6.9 — ** Net Product Sales $ 140.7 $ 97.9 44 % $ 509.3 $ 383.4 33 %
Product Pipeline Update
SPN-812 - Novel non-stimulant for the treatment of ADHD in children and adults
In February 2021, the Company received notice from the U.S. Food and Drug Administration (FDA) that its New Drug Application (NDA) resubmission for SPN-812 for the treatment of ADHD in pediatric patients is considered a Class I resubmission, thereby assigning a timeline of two months for review by the FDA and establishing a new Prescription Drug User Fee Act (PDUFA) target action date in early April 2021. The Company is preparing for the commercial launch of SPN-812 for the treatment of ADHD in pediatric patients in the second quarter of 2021, if approved by the FDA. In December 2020, the Company announced positive results from a Phase III trial in adult patients with ADHD. Assuming approval for pediatric patients, the Company plans to submit a supplemental NDA (sNDA) to the FDA for SPN-812 in adults in the second half of 2021. SPN-830 (Apomorphine infusion pump) - Continuous treatment of motor fluctuations (“on-off” episodes) in PD
The Company is scheduled to meet with the FDA in March 2021 in a Type A meeting to discuss the contents of the Refusal to File (RTF) letter it received in November 2020 regarding its NDA for SPN-830. In the letter, the FDA requested certain documents and reports to be submitted in support of the application. The Company believes additional testing of the device will be necessary to support the SPN-830 NDA resubmission. Supernus plans to resubmit the SPN-830 NDA after completing discussions with the FDA and the required activities for filing. SPN-820 - Novel first-in-class activator of mTORC1
Development activities are ongoing, including a multiple-ascending dose study in healthy volunteers, with the goal of initiating a Phase II clinical program in treatment-resistant depression by the end of 2021. Financial Highlights
Fourth quarter and full year 2020 operating earnings were $43.0 million and $173.7 million respectively, as compared to $40.8 million and $148.6 million in the fourth quarter 2019.
Fourth quarter 2020 net earnings and diluted earnings per share were $30.8 million and $0.57, respectively, as compared to $33.1 million , or $0.62 per diluted share, in the same period last year.
2020 full year net earnings and diluted earnings per share were $127.0 million and $2.36 per diluted share, respectively, as compared to $113.1 million and $2.10 per diluted share, for full year 2019.
As of December 31, 2020, the Company had $772.9 million in cash, cash equivalents and marketable securities, compared to $938.8 million as of December 31, 2019. During 2020, the Company made cash payments of approximately $300 million related to the acquisition of the CNS portfolio of US WorldMeds and $25 million to Navitor upon executing the development and option agreement for SPN-820.
Full Year 2021 Financial Guidance
The Company expects to achieve the following financial objectives in 2021:
Full Year 2021 Guidance ($ in millions) Total revenues (1) $550 - $580 Combined R&D and SG&A expenses (2) $380 - $410 Operating earnings (3) $65 - $90 Amortization of intangible assets $24
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1) Total revenues include net product sales and royalty revenue. Include $10 million for SPN-812 net product sales.
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, on Thursday, February 25, 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: 2253809 Conference Call Name: Supernus Pharmaceuticals Fourth Quarter and Full Year 2020 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, Inc. 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, 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 attention-deficit hyperactivity disorder (ADHD), 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. These forward-looking statements include expectations regarding the Company’s recent and future interactions and communications with the FDA concerning the NDAs for SPN-812 and SPN-830, any additional FDA requirements to support the SPN-830 NDA resubmissions, the potential approval of the NDAs for SPN-812 and SPN-830, the planned submission of an sNDA to the FDA for SPN-812 in adults and the potential benefits and commercialization of SPN-812 and SPN-830. 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 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 products and 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; 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.
Condensed Consolidated Balance Sheets (in thousands, except share data)
December 31, 2020 December 31, 2019 (unaudited) Assets Current assets Cash and cash equivalents $ 288,640 $ 181,381 Marketable securities 133,893 165,692 Accounts receivable, net 140,877 87,332 Inventories, net 48,325 26,628 Prepaid expenses and other current assets 18,682 11,611 Total current assets 630,417 472,644 Long term marketable securities 350,359 591,773 Property and equipment, net 37,824 17,068 Goodwill and intangible assets, net 442,253 24,840 Deferred income taxes — 32,063 Other assets 43,249 21,894 Total assets $ 1,504,102 $ 1,160,282 Liabilities and stockholders’ equity Current liabilities Accounts payable and accrued liabilities $ 78,934 $ 49,714 Accrued product returns and rebates 126,192 107,629 Contingent consideration, current portion 30,900 — Other current liabilities 9,082 3,244 Total current liabilities 245,108 160,587 Convertible notes, net 361,751 345,170 Contingent consideration, long term 45,800 — Operating lease liabilities, long term 28,579 30,440 Deferred income tax liabilities 35,215 — Other liabilities 42,791 28,657 Total liabilities 759,244 564,854 Stockholders’ equity Common stock, $0.001 par value; 130,000,000 shares authorized; 52,868,482 and 52,533,348 shares issued and outstanding as of December 31, 2020 and December 31, 2019, respectively 53 53 Additional paid-in capital 409,332 388,410 Accumulated other comprehensive earnings, net of tax 8,975 7,417 Retained earnings 326,498 199,548 Total stockholders’ equity 744,858 595,428 Total liabilities and stockholders’ equity $ 1,504,102 $ 1,160,282
Condensed Consolidated Statements of Earnings (in thousands, except share and per share data)
Three Months Ended December 31, Years Ended December 31, 2020 2019 2020 2019 (unaudited) (unaudited) Revenues Net product sales $ 140,743 $ 97,909 $ 509,350 $ 383,400 Royalty revenue 2,814 2,537 11,047 9,355 Total revenues 143,557 100,446 520,397 392,755 Costs and expenses Cost of goods sold (a) 18,533 4,113 52,459 16,660 Research and development 17,938 19,792 75,961 69,099 Selling, general and administrative 56,500 34,464 200,677 153,246 Amortization of intangible assets 5,888 1,261 15,702 5,179 Contingent consideration expense 1,700 — 1,900 — Total costs and expenses 100,559 59,630 346,699 244,184 Operating earnings 42,998 40,816 173,698 148,571 Other income (expense) Interest expense (6,096 ) (5,870 ) (23,754 ) (22,707 ) Interest and other income, net 2,791 5,966 18,704 21,623 Total other expense (3,305 ) 96 (5,050 ) (1,084 ) Earnings before income taxes 39,693 40,912 168,648 147,487 Income tax expense 8,925 7,783 41,698 34,431 Net earnings $ 30,768 $ 33,129 $ 126,950 $ 113,056 Earnings per share Basic $ 0.58 $ 0.63 $ 2.41 $ 2.16 Diluted $ 0.57 $ 0.62 $ 2.36 $ 2.10 Weighted-average shares outstanding Basic 52,708,643 52,471,389 52,615,269 52,412,181 Diluted 53,747,118 53,649,083 53,689,743 53,816,754
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(a) Excludes amortization of acquired intangible assets
Jack A. Khattar, President and Chief Executive Officer
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