GlobeNewswire Inc | Aug 18, 2020 06:06PM EDT

August 18, 2020

-- Total revenue of $126.7 million, including net product sales of $89.7 million for Trokendi XR, $23.7 million for Oxtellar XR, and $10.6 million for the acquired Parkinsons disease (PD) products -- Operating earnings of $45.5 million -- Completed acquisition of CNS portfolio of US WorldMeds on June 9, 2020 -- Executed a Development and Option Agreement with Navitor Pharmaceuticals, Inc. on SPN-820 (NV-5138) -- On track to launch SPN-812, if approved by the FDA, with shipments to the trade in December 2020 -- Topline data for the Phase III SPN-812 trial in adult patients expected in first quarter 2021 -- Updated full year 2020 financial guidance, reflecting acquisition of PD products as of June 9, 2020: net product sales ranging from $460 million to $500 million; operating earnings ranging from $90 million to $110 million.

ROCKVILLE, Md., Aug. 18, 2020 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today reported financial results for the second quarter of 2020 and associated Company developments.

Commercial Update

Second quarter 2020 net product sales of $124.0 million, 21% higher than the same period in 2019, driven by higher net product sales of Trokendi XR and Oxtellar XR and the addition of $10.6 million of net product sales from the acquired PD products. Net product sales of Trokendi XR and Oxtellar XR increased 11% compared to the same period in 2019 due to the beneficial impact of lower gross-to-net sales deductions in the second quarter of 2020, coupled with the price increase taken in January 2020. The year over year impact of volume, on an extended units basis (i.e., number of capsules/tablets), was neutral.

Net Product Sales($ in millions) Q2 2020 Q2 2019 Change %Trokendi XR $ 89.7 $ 79.0 14 %Oxtellar XR 23.7 23.4 1 %APOKYN^(1) 8.6 ? 100 %XADAGO^(1) 0.8 ? 100 %MYOBLOC^(1) 1.2 ? 100 %Total $ 124.0 $ 102.4 21 %

1 Net product sales from June 9, 2020 to June 30, 2020

Corporate and Product Pipeline Update

SPN-812 - Novel non-stimulant for the treatment of ADHD in children and adults

-- The Company continues to prepare for the commercial launch of SPN-812, with shipments to the trade in December 2020. The Company remains engaged with the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for the treatment of ADHD. The NDA Prescription Drug User Fee Act (PDUFA) target action date is November 8, 2020. -- Recruitment has resumed in the Phase III program in adult patients, after being put on hold in March 2020 due to the impact of the COVID-19 pandemic. The trial is expected to complete enrollment this year, with topline data expected in the first quarter of 2021.

SPN-830 (Apomorphine infusion pump) - continuous treatment of motor fluctuations (on-off episodes) in PD

-- NDA submission is expected in the fourth quarter of 2020, with launch, if approved by the FDA, in the second half of 2021.

SPN-820 novel first-in-class activator of mTORC1

-- Preclinical and development activities are ongoing, with the initiation of the Phase II clinical program in patients with treatment-resistant depression targeted for the second half of 2021.

Operating Expenses

Second Quarter

Research and development (R&D) expenses in the second quarter of 2020 were $22.2 million, compared to $17.0 million in the same quarter last year. This increase was primarily due to the $10.0 million option fee paid to Navitor as part of the collaboration agreement for SPN-820, coupled with expenses incurred in the SPN-812 Phase III program for adults. Increased expenses were partially offset by reduced spending for the SPN-810 Phase III trials.

Selling, general and administrative (SG&A) expenses in the second quarter of 2020 were $48.1 million, compared to $39.8 million in the same quarter last year. This increase is primarily due to $7.4 million of expense associated with the transaction to acquire the CNS portfolio of US WorldMeds in the second quarter of 2020, partially offset by $3.1 million in PDUFA fee refund from the FDA.

Operating Earnings and Earnings Per Share

Operating earnings (GAAP) in the second quarter of 2020 were $45.5 million, compared to $42.6 million in the second quarter of 2019. The increase was primarily due to increased net product sales, partially offset by the aforementioned option fee paid to Navitor and acquisition-related expenses associated with the acquired PD products.

Net earnings (GAAP) in the second quarter of 2020 were $34.7 million, or $0.65 per diluted share, as compared to $32.7 million, or $0.61 per diluted share, in the same period last year. Net earnings (GAAP) were subject to a higher effective tax rate of 27% in the second quarter of 2020 relative to the second quarter of 2019, due to the aforementioned transaction-related expenses associated with the acquired PD products, which are partially tax deductible, and an increase in the number of states in which the Company pays income tax.

Weighted-average diluted common shares outstanding were approximately 53.6 million for the second quarter of 2020, as compared to approximately 53.9 million for the prior year period.

Balance Sheet Highlights

As of June 30, 2020, the Company had $733.5 million in cash, cash equivalents, marketable securities and long term marketable securities, compared to $938.8 million at December 31, 2019. During the first six months of 2020, inclusive of net changes in working capital, the Company generated $100.9 million of cash from operations. During the second quarter, the Company made cash payments of approximately $300 million for the acquired PD products, as well as the aforementioned $10.0 million fee paid to Navitor as part of the development and option agreement for SPN-820.

Financial Guidance

Guidance was suspended in May 2020 due to several factors: the uncertainty caused by the COVID-19 pandemic; the second quarter 2020 acquisition of the PD products; and the impact of the partnership with Navitor. The Company is now reinstating and updating full year 2020 financial guidance, which consists of the following components, inclusive of the impact of acquiring the PD products as of June 9, 2020:

-- Net product sales to range from $460 million to $500 million, including approximately $80 million from the PD products. -- Gross margins of approximately 90%. -- R&D expenses of approximately $85 million. -- Selling, general and administrative expenses to range from $240 million to $250 million. -- Operating earnings (GAAP) to range from $90 million to $110 million, which includes amortization of intangible assets of approximately $15 million.

Conference Call Details

The Company will hold a conference call hosted by Jack Khattar, President and Chief Executive Officer, and Greg Patrick, Senior Vice President and Chief Financial Officer, to discuss these results at 9:00 a.m. Eastern Time, on Wednesday, August 19, 2020.

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) 288-1043International (970) 315-0267dial-in:Conference ID: 5175177Conference Call Supernus Pharmaceuticals Second Quarter 2020 EarningsName: 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 pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. The Company markets Trokendi XR (extended-release topiramate) for the prophylaxis of migraine and the treatment of epilepsy; Oxtellar XR (extended-release oxcarbazepine) for the treatment of epilepsy; APOKYN (apomorphine hydrochloride injection) for the acute treatment of hypomobility in advanced Parkinsons disease (PD); MYOBLOC (rimabotulinumtoxinB) for the treatment of cervical dystonia and treatment of chronic sialorrhea in adults; and XADAGO (safinamide) as an adjunctive treatment to levodopa/carbidopa in PD patients with hypomobility. The Company is also developing several product candidates to address large market opportunities in the CNS market, including SPN-812 for the treatment of ADHD; apomorphine infusion pump for hypomobility in PD; SPN-820 for treatment-resistant depression; and SPN-817 for the treatment of epilepsy.

See full Prescribing Information for our products here: Trokendi XR, Oxtellar XR, APOKYN, MYOBLOC, and XADAGO.

APOKYN Pen and the apomorphine infusion pump product candidate licensed from Britannia Pharmaceuticals Limited.XADAGO is licensed from Zambon S.p.A.All trademarks are the property of their respective owners.

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 Companys ability to sustain and increase its profitability; the Companys ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Companys corporate strategy; the Companys future financial performance and projected expenditures; the Companys ability to increase the number of prescriptions written for each of its products; the Companys ability to increase its net revenue; the Companys ability to enter into future collaborations with pharmaceutical companies and academic institutions or to obtain funding from government agencies; the Companys product research and development activities, including the timing and progress of the Companys clinical trials, and projected expenditures; the Companys ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Companys product candidates; the Companys ability to protect its intellectual property and operate its business without infringing upon the intellectual property rights of others; the Companys expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Companys product candidates; the accuracy of the Companys estimates of the size and characteristics of the markets that may be addressed by its product candidates; the Companys ability to increase its manufacturing capabilities for its products and product candidates; the Companys projected markets and growth in markets; the Companys product formulations and patient needs and potential funding sources; the Companys staffing needs; and other risk factors set forth from time to time in the Companys 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)

June 30, December 31, 2020 2019 (unaudited) Assets Current assets Cash and cash equivalents $ 210,975 $ 181,381Marketable securities 163,839 165,692Accounts receivable, net 126,559 87,332Inventories, net 35,338 26,628Prepaid expenses and other current assets 20,442 11,611Total current assets 557,153 472,644Long term marketable securities 358,673 591,773Property and equipment, net 17,941 17,068Operating lease assets 21,289 21,279Finance lease asset 22,479 ?Intangible assets, net 408,272 24,840Goodwill 88,095 ?Deferred income tax assets ? 32,063Other assets 17,118 615Total assets $ 1,491,020 $ 1,160,282 Liabilities and stockholders? equity Current liabilities Accounts payable $ 5,515 $ 10,141Accrued product returns and rebates 144,105 107,629Accrued expenses and other current liabilities 58,818 34,305Contingent consideration, current portion 23,500 ?Income taxes payable 25,052 2,443Operating lease liabilities, current portion 3,560 2,825Finance lease liability, current portion 4,201 ?Nonrecourse liability related to sale of future 4,525 3,244royalties, current portionTotal current liabilities 269,276 160,587Convertible notes, net 353,349 345,170Contingent consideration, long term 92,200 ?Nonrecourse liability related to sale of future 16,455 19,248royalties, long termOperating lease liabilities, long term 30,108 30,440Finance lease liability, long term 18,382 ?Deferred income tax liabilities 35,716 ?Other liabilities 9,560 9,409Total liabilities 825,046 564,854 Stockholders? equity Common stock, $0.001 par value; 130,000,000 sharesauthorized; 52,624,084 and 52,533,348 shares issued 53 53and outstanding as of June 30, 2020 and December31,2019, respectivelyAdditional paid-in capital 398,829 388,410Accumulated other comprehensive earnings, net of tax 11,359 7,417Retained earnings 255,733 199,548Total stockholders? equity 665,974 595,428 Total liabilities and stockholders? equity $ 1,491,020 $ 1,160,282

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

Three Months ended Six Months ended June 30, June 30, 2020 2019 2020 2019 (unaudited) (unaudited)Revenues Net product $ 123,984 $ 102,358 $ 216,474 $ 185,457 salesRoyalty revenues 2,745 2,337 5,231 4,712 Total revenues 126,729 104,695 221,705 190,169 Costs and expensesCost of goods 8,386 4,044 12,538 7,728 sold^(a)Research and 22,247 16,970 41,184 32,364 developmentSelling, generaland 48,103 39,777 89,717 79,439 administrativeAmortization ofintangible 2,445 1,306 3,706 2,612 assets Total costs and 81,181 62,097 147,145 122,143 expenses Operating 45,548 42,598 74,560 68,026 earnings Other income (expense)Interest income 4,151 5,448 9,726 10,137 Interest expense (5,815 ) (5,389 ) (11,570 ) (11,268 )Other income, 3,326 89 3,528 90 netTotal other 1,662 148 1,684 (1,041 )income (expense) Earnings before 47,210 42,746 76,244 66,985 income taxes Income tax 12,543 10,019 20,059 15,918 expenseNet earnings $ 34,667 $ 32,727 $ 56,185 $ 51,067 Earnings per shareBasic $ 0.66 $ 0.62 $ 1.07 $ 0.98 Diluted $ 0.65 $ 0.61 $ 1.05 $ 0.95 Weighted-averageshares outstandingBasic 52,557,035 52,385,590 52,545,910 52,361,149 Diluted 53,645,828 53,912,977 53,611,418 53,947,834

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(a) Excludes amortization of acquired intangible assets

CONTACTS:

Jack A. Khattar, President and CEOGregory S. Patrick, Senior Vice President and CFOSupernus Pharmaceuticals, Inc.Tel: (301) 838-2591

or

INVESTOR CONTACT:Peter VozzoWestwicke, an ICR CompanyOffice: (443) 213-0505Mobile: (443) 377-4767Email: peter.vozzo@westwicke.com