GlobeNewswire Inc | May 5, 2021 04:01PM EDT

May 05, 2021

-- First quarter 2021 total revenues of $130.9 million, a 38% increase compared to 2020 -- Qelbree approved by FDA for pediatric ADHD and on track for a U.S. launch in Q2 2021 -- Qelbree sNDA submission for adult ADHD anticipated in the third quarter of 2021 -- SPN-830 (apomorphine infusion pump) NDA resubmission anticipated in the second half of 2021 -- SPN-820 (mTORC1) has advanced towards a Phase II clinical program in treatment-resistant depression following successful completion of MAD study

ROCKVILLE, Md., May 05, 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 first quarter of 2021, and associated Company developments.

The approval of Qelbree provides pediatric patients living with ADHD a therapy with proven efficacy and a tolerable safety profile, and that is not a controlled substance, said Jack Khattar, President and CEO of Supernus Pharmaceuticals. Our Qelbree commercial launch activities are ongoing and include engagement with both physicians and patient groups who have expressed great interest in this unique new alternative for the treatment of ADHD.

Net Product Sales

First quarter 2021 net product sales were $128.4 million, 39% higher than the same period in 2020.

Net Product Sales ($ in millions) Q1 2021 Q1 2020 Change %Trokendi XR^ $ 71.8 $ 68.6 5 %Oxtellar XR^ 27.4 23.9 14 %APOKYN^ 21.7 ? ** MYOBLOC^ 4.3 ? ** XADAGO^ 3.2 ? ** Net Product Sales $ 128.4 $ 92.5 39 %

Qelbree Launch Update

-- In April 2021, the U.S. Food and Drug Administration (FDA) approved Qelbree for the treatment of attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age. The Company plans to make Qelbree available in the U.S. during the second quarter of 2021. -- Supernus will conduct post-marketing commitment studies, including a new study of Qelbree in preschool aged children with ADHD, 4 to 5 years of age. The completion of these studies responds to a written request from the FDA and should therefore result in the FDA granting an additional 6 months of market exclusivity.

Product Pipeline Update

Qelbree (viloxazine, extended-release capsules) - Novel non-stimulant for the treatment of ADHD in adults

-- In December 2020, the Company announced positive results from a Phase III trial in adult patients with ADHD and plans to submit a supplemental New Drug Application (sNDA) to the FDA for Qelbree in adults in the third quarter of 2021.

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

-- The company recently met with the FDA to discuss the path forward for resubmission of the SPN-830 NDA. The FDA provided additional clarity related to the contents of the November 2020 Refusal to File (RTF) letter and the requirements for resubmission. The Company now plans to resubmit the SPN-830 NDA in the second half of 2021.

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

-- SPN-820 has advanced to a Phase II clinical program in treatment-resistant depression following the successful completion of a multiple-ascending dose (MAD) study in healthy volunteers. In the MAD study, SPN-820 exhibited a favorable safety and tolerability profile across a broad range of potentially therapeutic doses. -- The Company expects to initiate a randomized Phase II clinical study in treatment-resistant depression by the end of 2021.

Financial Highlights

First quarter 2021 operating earnings were $13.2 million, as compared to $29.0 million in the first quarter 2020. In the first quarter of 2021, the Company recorded non-cash research and development expense of $15million related to the equity investment in Navitor as a result of the accounting impact of the March 2021 Navitor corporate restructuring and non-cash contingent consideration expense of $1 million associated with the 2020 USWM acquisition. Operating earnings for the first quarter of 2021 included amortization of intangible assets expense of $6.0 million, compared to $1.3 million in the first quarter of 2020.

First quarter 2021 net earnings and diluted earnings per share were $5.7 million and $0.11, respectively, as compared to $21.5 million, or $0.40 per diluted share, in the same period last year.

As of March 31, 2021, the Company had $807.7 million in cash, cash equivalents and marketable securities, compared to $772.9 million as of December 31, 2020.

Full Year 2021 Financial Guidance

For full year 2021, the Company reiterates its prior financial guidance and added full year 2021 effective tax rate guidance as set forth below:

Full Year 2021 Guidance ($ in millions)Total revenues^1 $550 - $580Combined R&D and SG&A expenses^2 $380 - $410Operating earnings^3 $65 - $90Amortization of intangible assets $24Effective Tax Rate^4 28% - 31%

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1)Total revenues includes net product sales and royalty revenue. Includes $10million for Qelbreenet 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.4)The full year 2021 effective tax rate guidance of 28% - 31% is above the normally expected range of 26% - 28% due to the effect of discrete tax items in the period.

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, today, May 5, 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) 288-1043International (970) 315-0267dial-in:Conference ID: 9275942Conference Call Supernus Pharmaceuticals First Quarter 2021 ResultsName: 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 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 Parkinsons disease, cervical dystonia and chronic sialorrhea. We are developing a broad range of novel CNS product candidates including new potential treatments for hypomobility in Parkinsons 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. 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 revenue and expenditures; the Companys ability to increase the number of prescriptions written for each of its products; the Companys ability to increase its revenues; the Companys ability to commercialize its products including Qelbree; 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; the Companys ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Companys product candidates including SPN-830 and SPN-812 for adult ADHD patients; 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)

March 31, December 31, 2021 2020 (unaudited) Assets Current assets Cash and cash equivalents $ 255,642 $ 288,640 Marketable securities 135,459 133,893 Accounts receivable, net 127,065 140,877 Inventories, net 50,226 48,325 Prepaid expenses and other current assets 17,631 18,682 Total current assets 586,023 630,417 Long term marketable securities 416,566 350,359 Property and equipment, net 37,950 37,824 Intangible assets, net 358,736 364,342 Goodwill 77,911 77,911 Other assets 30,257 43,249 Total assets $ 1,507,443 $ 1,504,102 Liabilities and stockholders? equity Current liabilities Accounts payable and accrued liabilities $ 70,099 $ 78,934 Accrued product returns and rebates 128,736 126,192 Contingent consideration, current portion 31,520 30,900 Other current liabilities 10,457 9,082 Total current liabilities 240,812 245,108 Convertible notes, net 366,038 361,751 Contingent consideration, long term 46,200 45,800 Operating lease liabilities, long term 28,532 28,579 Deferred income tax liabilities 31,742 35,215 Other liabilities 39,675 42,791 Total liabilities 752,999 759,244 Stockholders? equity Common stock, $0.001 par value; 130,000,000shares authorized; 52,994,137 and 52,868,482 53 53 shares issued and outstanding as of March 31,2021 and December31, 2020, respectivelyAdditional paid-in capital 415,950 409,332 Accumulated other comprehensive earnings, net of 6,249 8,975 taxRetained earnings 332,192 326,498 Total stockholders? equity 754,444 744,858 Total liabilities and stockholders? equity $ 1,507,443 $ 1,504,102

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

Three Months ended March 31, 2021 2020 (unaudited)Revenues Net product sales $ 128,381 $ 92,490 Royalty revenues 2,551 2,486 Total revenues 130,932 94,976 Costs and expenses Cost of goods sold ^(a) 14,954 4,152 Research and development 34,280 18,937 Selling, general and administrative 61,457 41,614 Amortization of intangible assets 6,007 1,261 Contingent consideration expense 1,020 ? Total costs and expenses 117,718 65,964 Operating earnings 13,214 29,012 Other income (expense) Interest expense (6,097 ) (5,755 ) Interest and other income, net 3,812 5,777 Total other income (expense) (2,285 ) 22 Earnings before income taxes 10,929 29,034 Income tax expense 5,235 7,516 Net earnings $ 5,694 $ 21,518 Earnings per share Basic $ 0.11 $ 0.41 Diluted $ 0.11 $ 0.40 Weighted-average shares outstanding Basic 52,927,467 52,534,787 Diluted 54,196,971 53,581,051

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(a) Excludes amortization of acquired intangible assets

CONTACTS:

Jack A. Khattar, President and CEOJim Kelly, Executive Vice President and CFOSupernus Pharmaceuticals, Inc.Tel: (301) 838-2591

or

INVESTOR CONTACT:Peter VozzoWestwicke/ICROffice: (443) 213-0505Mobile: (443) 377-4767Email: peter.vozzo@westwicke.com