GlobeNewswire Inc | Nov 3, 2020 04:30PM EST

November 03, 2020

-- Q3 2020 total revenues of $155.1 million, including net product sales of $152.1 million and royalty revenues of $3.0 million -- Q3 2020 operating earnings of $56.1 million -- On track to initiate commercial launch of SPN-812 in January 2021, if approved by the FDA -- Topline data from the SPN-812 Phase III trial in adult ADHD patients expected in Q1 2021 -- Submitted SPN-830 (Apomorphine infusion pump) NDA to the FDA in September 2020 -- Increased full year 2020 net product sales guidance range of $500 million to $525 million, and operating earnings guidance range of $145 million to $160 million

ROCKVILLE, Md., Nov. 03, 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 third quarter of 2020 and associated Company developments.

During the first nine months of 2020, we delivered strong product sales growth, diversified our revenue base and enhanced our long term growth with two corporate transactions said Jack Khattar, President and CEO of Supernus. Our employees have been hard at work in anticipation of the launch of SPN-812. Based on the efficacy and safety demonstrated in its clinical program, SPN-812 can potentially offer an important new option in the treatment of ADHD.

Commercial Update

Third quarter 2020 net product sales were $152.1 million, 52% higher than the same period in 2019, driven by the addition of $40.9 million of net product sales from the acquired commercial products and $11.2 million in net product sales growth from Trokendi XR and Oxtellar XR.

Net Product Sales($ in millions) Q3 2020 Q3 2019 Change %Trokendi XR $ 82.9 $ 77.3 7%Oxtellar XR 28.3 22.7 25%APOKYN 34.5 ? NM^(1)XADAGO 2.3 ? NM^(1)MYOBLOC 4.1 ? NM^(1)Total $ 152.1 $ 100.0 52%

____________(1)Fluctuation in terms of percentage change is not meaningful.

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, which is expected in January 2021, if approved by the FDA. The New Drug Application (NDA) Prescription Drug User Fee Act (PDUFA) target action date is November 8, 2020. -- The Company completed enrollment in the SPN-812 Phase III trial in adult patients with ADHD. Topline data from the trial is expected in the first quarter of 2021.

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

-- NDA was submitted to the U.S. Food and Drug Administration (FDA) in September 2020 for the continuous treatment of "on-off" episodes in adults with Parkinson's disease (PD) whose motor control is unsatisfactory with oral levodopa and at least one other noninvasive PD therapy. -- The Company expects to launch SPN-830 in the fourth quarter of 2021, if approved by the FDA.

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

-- Preclinical and development activities are ongoing, with the goal of initiating a Phase II clinical program in treatment-resistant depression by the end of 2021.

Operating Expenses

Research and development (R&D) expenses in the third quarter of 2020 were $16.8 million, essentially unchanged from $16.9 million in the same quarter last year.

Selling, general and administrative (SG&A) expenses in the third quarter of 2020 were $54.7 million, compared to $39.3 million in the same quarter last year. This increase was primarily due to costs associated with the new CNS portfolio of commercial products acquired from US WorldMeds (USWM Acquisition) in the second quarter of 2020 and our ongoing preparations for the potential launch of SPN-812.

Amortization expense of intangible assets in the third quarter of 2020 were $6.1 million, compared to $1.3 million in the same quarter last year. This increase results from the USWM Acquisition.

Operating Earnings and Earnings Per Share

Operating earnings (GAAP) in the third quarter of 2020 were $56.1 million, compared to $39.7 million in the third quarter of 2019. Net earnings (GAAP) in the third quarter of 2020 were $40.0 million, or $0.74 per diluted share, as compared to $28.9 million, or $0.54 per diluted share, in the same period last year.

Balance Sheet Highlights

As of September 30, 2020, the Company had $740.1 million in cash, cash equivalents, marketable securities and long term marketable securities, compared to $938.8 million at December 31, 2019. During the first nine months of 2020, the Company generated $107.5 million of cash from operations, inclusive of net changes in working capital. The Company made cash payments of approximately $300 million for acquisition of the CNS portfolio of US WorldMeds and $25 million paid to Navitor upon executing the development and option agreement for SPN-820.

Financial Guidance

The Company is revising full year 2020 financial guidance, which consists of the following components, inclusive of the impact of acquiring the CNS portfolio of US WorldMeds as of June 9, 2020:

($ in millions) Current (As of November 3, Previous (As of August 18, 2020) 2020)Net product sales $500 - $525 $460 - $500Research and Approximately $75 Approximately $85development expenseSelling, general andadministrative $215 - $225 $240 - $250expenseAmortization of $16 $15intangible assetsOperating earnings $145 - $160, including $90 - $110, including(GAAP) amortization of intangible amortization of intangible assets assets

Conference Call Details

The Company will hold a conference call hosted by Jack Khattar, President and Chief Executive Officer and the executive management team to discuss these results at 9:00 a.m. Eastern Time, on Wednesday, November 4, 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: 1882244Conference Call Supernus Pharmaceuticals Third 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

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)

September 30, December 31, 2020 2019 (unaudited) Assets Current assets Cash and cash equivalents $ 204,293 $ 181,381 Marketable securities 147,657 165,692 Accounts receivable, net 133,107 87,332 Inventories, net 42,465 26,628 Prepaid expenses and other current assets 24,493 11,611 Total current assets 552,015 472,644 Long term marketable securities 388,185 591,773 Property and equipment, net 17,395 17,068 Operating lease assets 21,019 21,279 Finance lease asset 21,676 ? Intangible assets, net 402,265 24,840 Goodwill 89,143 ? Deferred income tax assets ? 32,063 Other assets 18,324 615 Total assets $ 1,510,022 $ 1,160,282 Liabilities and stockholders? equity Current liabilities Accounts payable $ 11,193 $ 10,141 Accrued product returns and rebates 136,973 107,629 Accrued expenses and other current liabilities 56,289 34,305 Contingent consideration, current portion 82,900 ? Income taxes payable ? 2,443 Operating lease liabilities, current portion 3,741 2,825 Finance lease liability, current portion 3,612 ? Nonrecourse liability related to sale of future 4,898 3,244 royalties, current portionTotal current liabilities 299,606 160,587 Convertible notes, net 357,521 345,170 Contingent consideration, long term 33,000 ? Nonrecourse liability related to sale of future 14,960 19,248 royalties, long termOperating lease liabilities, long term 29,522 30,440 Finance lease liability, long term 19,289 ? Deferred income tax liabilities 37,941 ? Other liabilities 9,304 9,409 Total liabilities 801,143 564,854 Stockholders? equity Common stock, $0.001 par value; 130,000,000shares authorized; 52,670,121 and 52,533,348 53 53 shares issued and outstanding as of September 30,2020 and December31, 2019, respectivelyAdditional paid-in capital 403,396 388,410 Accumulated other comprehensive earnings, net of 9,700 7,417 taxRetained earnings 295,730 199,548 Total stockholders? equity 708,879 595,428 Total liabilities and stockholders? equity $ 1,510,022 $ 1,160,282

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

Three Months ended Nine Months ended September 30, September 30, 2020 2019 2020 2019 (unaudited) (unaudited)Revenues Net product $ 152,133 $ 100,034 $ 368,607 $ 285,491 salesRoyalty revenues 3,002 2,106 8,233 6,818 Total revenues 155,135 102,140 376,840 292,309 Costs and expensesCost of goods 21,388 4,819 33,926 12,547 sold^(a)Research and 16,839 16,943 58,023 49,307 developmentSelling, generaland 54,660 39,343 144,377 118,782 administrativeAmortization ofintangible 6,108 1,306 9,814 3,918 assetsTotal costs and 98,995 62,411 246,140 184,554 expenses Operating 56,140 39,729 130,700 107,755 earnings Other income (expense)Interest income 3,262 5,559 12,988 15,696 Interest expense (6,088 ) (5,662 ) (17,658 ) (16,930 ) Other income (603 ) (36 ) 2,925 54 (expense), netTotal other (3,429 ) (139 ) (1,745 ) (1,180 ) expense Earnings before 52,711 39,590 128,955 106,575 income taxes Income tax 12,714 10,730 32,773 26,648 expenseNet earnings $ 39,997 $ 28,860 $ 96,182 $ 79,927 Earnings per shareBasic $ 0.76 $ 0.55 $ 1.83 $ 1.53 Diluted $ 0.74 $ 0.54 $ 1.79 $ 1.48 Weighted-averageshares outstandingBasic 52,658,850 52,453,384 52,583,891 52,392,232 Diluted 53,762,642 53,805,838 53,663,273 53,898,486

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(a) Excludes amortization of acquired intangible assets

CONTACTS:

Jack A. Khattar, President and Chief Executive Officer Jim Kelly, EVP & Chief Financial OfficerSupernus Pharmaceuticals, Inc.Tel: (301) 838-2591

or

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