Supernus Announces First Quarter 2021 Financial Results

Rhea-AI Summary

Supernus Pharmaceuticals (SUPN) reported Q1 2021 total revenues of $130.9 million, a 38% increase from Q1 2020. Net product sales totaled $128.4 million, up 39% year-over-year, driven by Trokendi XR and Oxtellar XR. The FDA approved Qelbree for pediatric ADHD, with a planned launch in Q2 2021 and an sNDA for adults anticipated in Q3 2021. Operating earnings were $13.2 million, down from $29.0 million in the previous year. The company has $807.7 million in cash and reiterates its full-year revenue guidance of $550 - $580 million.

Positive

• Q1 2021 total revenues increased by 38% year-over-year.
• Net product sales rose to $128.4 million, a 39% increase from Q1 2020.
• FDA approval of Qelbree provides a new treatment option for pediatric ADHD.
• Strong cash position with $807.7 million as of March 31, 2021.
• Full-year revenue guidance set between $550 and $580 million.

Negative

• Operating earnings decreased to $13.2 million from $29.0 million in the previous year.
• Net earnings dropped significantly to $5.7 million compared to $21.5 million in Q1 2020.
• Increased amortization expenses totaling $6.0 million, up from $1.3 million last year.

• 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 $15 million 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 revenues1	$550 - $580
Combined R&D and SG&A expenses2	$380 - $410
Operating earnings3	$65 - $90
Amortization of intangible assets	$24
Effective Tax Rate4	28% - 31%

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1)   Total revenues includes net product sales and royalty revenue. Includes $10 million for Qelbree™ 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.
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) 288-1043
International dial-in:	(970) 315-0267
Conference ID:	9275942
Conference Call Name:	Supernus Pharmaceuticals First Quarter 2021 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 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 Parkinson’s disease, cervical dystonia and chronic sialorrhea. We are developing a broad range of novel CNS product candidates including new potential treatments for 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. 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 revenue and expenditures; the Company’s ability to increase the number of prescriptions written for each of its products; the Company’s ability to increase its revenues; the Company’s ability to commercialize its products including Qelbree; the Company’s ability to enter into future collaborations with pharmaceutical companies and academic institutions or to obtain funding from government agencies; the Company’s product research and development activities, including the timing and progress of the Company’s clinical trials; the Company’s ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company’s product candidates including SPN-830 and SPN-812 for adult ADHD patients; 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 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 and 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.

Supernus Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share data)

	March 31, 2021				December 31, 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; 130,000,000 shares authorized; 52,994,137 and 52,868,482 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively	53				53
Additional paid-in capital	415,950				409,332
Accumulated other comprehensive earnings, net of tax	6,249				8,975
Retained 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 CEO
Jim Kelly, Executive Vice President and CFO
Supernus Pharmaceuticals, Inc.
Tel: (301) 838-2591

or

INVESTOR CONTACT:
Peter Vozzo
Westwicke/ICR
Office: (443) 213-0505
Mobile: (443) 377-4767
Email: peter.vozzo@westwicke.com

FAQ

What were the total revenues for Supernus Pharmaceuticals in Q1 2021?

Supernus Pharmaceuticals reported total revenues of $130.9 million in Q1 2021.

How much did net product sales increase in Q1 2021?

Net product sales increased by 39%, totaling $128.4 million in Q1 2021.

What is the anticipated launch date for Qelbree?

Qelbree is expected to launch in the U.S. during Q2 2021.

What is Supernus's financial guidance for full-year 2021?

Supernus Pharmaceuticals projects total revenues between $550 million and $580 million for full-year 2021.

What were Supernus's operating earnings in Q1 2021?

Operating earnings for Q1 2021 were $13.2 million.