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| 8-K - 8-K - SUPERNUS PHARMACEUTICALS, INC. | supn-20210225.htm |
Exhibit 99.1
Supernus Announces Fourth Quarter and Full Year 2020 Financial Results
•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, February 25, 2021 - 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.
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•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.
2) Combined research and development and selling, general and administrative expenses.
3) Operating earnings include amortization of intangible assets and contingent consideration expense.
Conference Call Details
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
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| 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.
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Supernus Pharmaceuticals, Inc.
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 | |||||||
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Supernus Pharmaceuticals, Inc.
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
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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
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