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Supernus Announces Second Quarter 2021 Financial Results

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·10-min read
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  • Second quarter 2021 total revenues of $141.3 million, a 12% increase compared to 2020

  • Qelbree™ launched in the U.S. for pediatric ADHD at the end of May 2021

  • Qelbree sNDA for adult ADHD submitted to the FDA

  • SPN-830 (apomorphine infusion pump) NDA resubmission anticipated in the second half of 2021

ROCKVILLE, Md., Aug. 04, 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 second quarter of 2021, and associated Company developments.

“The approval and commercial launch of Qelbree for pediatric patients with ADHD mark an important milestone for children and families searching for new treatment options for ADHD,” said Jack Khattar, President and CEO of Supernus Pharmaceuticals. “As a non-controlled substance that has a unique profile of proven efficacy, safety and tolerability, Qelbree provides patients living with ADHD a novel treatment option like no other ADHD medication.”

Net Product Sales

Second quarter 2021 net product sales were $138.6 million, 12% higher than the same period in 2020.

Net Product Sales

($ in millions)

Q2 2021

Q2 2020 (1)

Change %

Trokendi XR®

$

78.8

$

89.7

(12

)

%

Oxtellar XR®

25.0

23.7

6

%

APOKYN®

27.0

8.6

**

MYOBLOC®

4.6

1.2

**

XADAGO®

2.9

0.8

**

Qelbree

0.3

**

Net Product Sales

$

138.6

$

124.0

12

%

___________________________________________

(1) Net product sales of APOKYN, MYOBLOC and XADAGO from June 9, 2020 to June 30, 2020.

Qelbree Launch Update

  • At the end of May 2021, Supernus launched Qelbree for the treatment of attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age. Net product sales for the second quarter of 2021 were $0.3 million.

  • The early performance of Qelbree is on track with our expectations. Current trends in prescriptions reflect the heavy sampling programs with patients. Over 25,000 starter kits have been distributed to physicians since the launch and in preparation for the back-to-school season.

  • Early clinical feedback about the performance of Qelbree in patients is positive and in line with the Phase III clinical results.

Product Pipeline Update

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

  • The Company recently submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Qelbree for adult patients with ADHD.

SPN-830 (apomorphine infusion pump) - Continuous treatment of motor fluctuations (“on-off” episodes) in Parkinson's disease (PD)

  • The Company continues to plan to resubmit the SPN-830 NDA in the second half of 2021.

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

  • A randomized Phase II clinical study of SPN-820 in treatment-resistant depression is expected to start by the end of 2021.

Financial Highlights

Second quarter 2021 operating earnings were $34.1 million, as compared to $45.5 million in the second quarter of 2020. Operating earnings for the second quarter of 2021 included amortization of intangible assets expense of $5.9 million, compared to $2.4 million in the second quarter of 2020.

Second quarter 2021 net earnings and diluted earnings per share were $23.7 million and $0.43, respectively, as compared to $34.7 million, or $0.65 per diluted share, in the same period last year.

As of June 30, 2021, the Company had $855.3 million in cash, cash equivalents, current and long-term 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 including an increase to the lower end of its operating earnings guidance as set forth below:

Full Year 2021 Guidance
($ in millions)

Total revenues (1)

$550 - $580

Combined R&D and SG&A expenses (2)

$380 - $410

Operating earnings (3)

$70 - $90

Amortization of intangible assets

$24

Effective tax rate(4)

28% - 31%

___________________________________________
(1) Total revenues include 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 (gain). Reflects an increase from the original guidance of $65 - $90 million.
(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, August 4, 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:

1687420

Conference Call Name:

Supernus Pharmaceuticals Second 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 expenditures; the Company’s ability to increase the number of prescriptions written for each of its products; the Company’s ability to increase its net revenue; 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, 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 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)

June 30, 2021

December 31, 2020

(unaudited)

Assets

Current assets

Cash and cash equivalents

$

223,771

$

288,640

Marketable securities

186,070

133,893

Accounts receivable, net

137,275

140,877

Inventories, net

58,391

48,325

Prepaid expenses and other current assets

33,737

18,682

Total current assets

639,244

630,417

Long term marketable securities

445,473

350,359

Property and equipment, net

17,065

37,824

Intangible assets, net

352,628

364,342

Goodwill

77,963

77,911

Other assets

40,687

43,249

Total assets

$

1,573,060

$

1,504,102

Liabilities and stockholders’ equity

Current liabilities

Accounts payable and accrued liabilities

$

79,993

$

78,934

Accrued product returns and rebates

173,598

126,192

Contingent consideration, current portion

23,540

30,900

Other current liabilities

6,316

9,082

Total current liabilities

283,447

245,108

Convertible notes, net

370,383

361,751

Contingent consideration, long term

45,430

45,800

Operating lease liabilities, long term

36,143

28,579

Deferred income tax liabilities

32,986

35,215

Other liabilities

19,092

42,791

Total liabilities

787,481

759,244

Stockholders’ equity

Common stock, $0.001 par value; 130,000,000 shares authorized; 53,144,759 and 52,868,482 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively

53

53

Additional paid-in capital

424,175

409,332

Accumulated other comprehensive earnings, net of tax

5,433

8,975

Retained earnings

355,918

326,498

Total stockholders’ equity

785,579

744,858

Total liabilities and stockholders’ equity

$

1,573,060

$

1,504,102

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

Three Months ended
June 30,

Six Months ended
June 30,

2021

2020

2021

2020

(unaudited)

(unaudited)

Revenues

Net product sales

$

138,628

$

123,984

$

267,009

$

216,474

Royalty revenues

2,701

2,745

5,252

5,231

Total revenues

141,329

126,729

272,261

221,705

Costs and expenses

Cost of goods sold (a)

25,028

8,386

39,982

12,538

Research and development

15,455

22,247

49,735

41,184

Selling, general and administrative

69,535

48,103

130,992

89,717

Amortization of intangible assets

5,948

2,445

11,955

3,706

Contingent consideration gain

(8,750

)

(7,730

)

Total costs and expenses

107,216

81,181

224,934

147,145

Operating earnings

34,113

45,548

47,327

74,560

Other income (expense)

Interest expense

(5,467

)

(5,815

)

(11,564

)

(11,570

)

Interest and other income, net

2,589

7,477

6,401

13,254

Total other income (expense)

(2,878

)

1,662

(5,163

)

1,684

Earnings before income taxes

31,235

47,210

42,164

76,244

Income tax expense

7,509

12,543

12,744

20,059

Net earnings

$

23,726

$

34,667

$

29,420

$

56,185

Earnings per share

Basic

$

0.45

$

0.66

$

0.56

$

1.07

Diluted

$

0.43

$

0.65

$

0.54

$

1.05

Weighted-average shares outstanding

Basic

53,005,344

52,557,035

52,985,472

52,545,910

Diluted

54,724,146

53,645,828

54,601,533

53,611,418

___________________________________________

(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


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