UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): August 7, 2018

 

Supernus Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

(State or other jurisdiction of
Incorporation)

 

001-35518

 

20-2590184

(Commission File Number)

 

(IRS Employer Identification No.)

 

1550 East Gude Drive, Rockville MD

 

20850

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code:  (301) 838-2500

 

Not Applicable

(Former name or former address, if changed since last report.)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). o

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

 

 

 



 

Item 2.02              Results of Operations and Financial Condition.

 

On August 7, 2018, Supernus Pharmaceuticals, Inc. (“Supernus” or the “Company”) issued a press release regarding its financial results for the second quarter ended June 30, 2018. A copy of this press release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.

 

As previously announced, Supernus will host a conference call at 9:00 a.m. Eastern Time on Wednesday, August 8, 2018, to present the financial results. A live webcast will be available at www.supernus.com. The webcast will be archived on the Company’s website for 60 days following the live call. Callers should dial in approximately 10 minutes prior to the start of the call. The phone number to join the conference call is +1 (877) 288-1043 (U.S. and Canada) or +1 (970) 315-0267 (international). The access code for the live call is 7484048.

 

The information in this Item 2.02 (including Exhibit 99.1) is being “furnished” and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, whether made before or after the date of this report, except as shall be expressly set forth by specific reference in such filing.

 

This Current Report on Form 8-K contains “forward-looking statements” that do not convey historical information, but relate to predicted or potential future events, such as statements of our plans, strategies and intentions. These statements can often be identified by the use of forward-looking terminology such as “believe,” “expect,” “intend,” “may,” “will,” “should,” or “anticipate” or similar terminology. All statements other than statements of historical facts included in this Current Report on Form 8-K are forward-looking statements. All forward-looking statements speak only as of the date of this Current Report on Form 8-K. Except for Supernus’ ongoing obligations to disclose material information under the federal securities laws, Supernus undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. In addition to the risks and uncertainties of ordinary business operations and conditions in the general economy and the markets in which Supernus competes, the forward-looking statements of Supernus contained in this Current Report on Form 8-K are also subject to various risks and uncertainties, including those set forth in Item 1A, “Risk Factors,” in Supernus’ Annual Report on Form 10-K for the fiscal year ended December 31, 2017, which the Company filed on March 1, 2018 and the Quarterly Report on Form 10-Q for the quarter period ended March 31, 2018, which the Company filed on May 10, 2018.

 

Item 9.01              Financial Statements and Exhibits.

 

(d)           Exhibit

 

The following document is furnished as an Exhibit pursuant to Item 2.02 hereof:

 

Exhibit 99.1 – Press Release Dated August 7, 2018.

 

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EXHIBIT INDEX

 

Number

 

Description

 

 

 

 

 

 

 

99.1

 

Press Release Dated August 7, 2018.

 

Attached

 

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

 

SUPERNUS PHARMACEUTICALS, INC.

 

 

 

 

 

 

DATED: August 7, 2018

By:

/s/Gregory S. Patrick

 

 

Gregory S. Patrick

 

 

Vice-President and Chief Financial Officer

 

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Exhibit 99.1

 

 

Supernus Announces Second Quarter 2018 Financial Results and

Record Quarterly Revenue

 

·                  Total revenue of $99.5 million, a 31% increase over 2017

 

·                  Net product sales of $97.0 million, a 32% increase over 2017

 

·                  Operating earnings of $35.7 million, a 37% increase over 2017

 

·                  Diluted earnings per share (GAAP) of $0.57, a 78% increase over 2017

 

·                  Completed enrollment in the first SPN-812 Phase III trial (P301), with data expected in the fourth quarter of 2018

 

ROCKVILLE, Md., August 7, 2018 - Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today reported record financial results for the second quarter of 2018 and related Company developments.

 

Commercial Update

 

Second quarter 2018 product prescriptions for Trokendi XR® and Oxtellar XR®, as reported by IQVIA, totaled 214,841, a 35.5% increase over the second quarter of 2017.

 

Prescriptions

 

 

 

 

 

 

 

 

 

 

Q2 2018

 

Q2 2017

 

Change %

 

Trokendi XR

 

177,052

 

124,089

 

42.7

%

Oxtellar XR

 

37,789

 

34,468

 

9.6

%

Total

 

214,841

 

158,557

 

35.5

%

 

Source:  IQVIA

 

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Net product sales for the second quarter of 2018 were $97.0 million, a 32.3% increase over $73.3 million in the second quarter of 2017.

 

Net Product Sales ($ in millions)

 

 

 

 

 

 

 

 

 

 

Q2 2018

 

Q2 2017

 

Change %

 

Trokendi XR

 

$

76.4

 

$

56.0

 

36.4

%

Oxtellar XR

 

$

20.6

 

$

17.3

 

19.1

%

Total

 

$

97.0

 

$

73.3

 

32.3

%

 

“Solid commercial execution has enabled Supernus to generate another strong quarter of growth, setting a new record for both Trokendi XR and Oxtellar XR quarterly net product sales,” said Jack Khattar, President and CEO of Supernus Pharmaceuticals.

 

Progress of Product Pipeline

 

SPN-812 — Novel non-stimulant for the treatment of ADHD

 

·                  The program consists of four three-arm, placebo-controlled trials: P301 and P302 trials in patients 6-11 years old, and P303 and P304 trials in adolescent patients.

 

·                  Enrollment is complete in the P301 trial, with data expected in the fourth quarter of 2018.

 

·                  The remaining three trials are at approximately 89% enrollment, with data expected in the first quarter of 2019.

 

·                  Roll-over from the four Phase III trials to the open label extension study is approximately 90%.

 

SPN-810 — Treatment of Impulsive Aggression in patients with ADHD

 

·                  Enrollment in the Phase III pediatric trials, P301 and P302, is approximately 91% and 77%, respectively.

 

·                  The Company anticipates having data from P301 by the first quarter of 2019 and data from P302 by mid-2019.

 

·                  Roll-over from the two Phase III trials to the open label extension study continues at approximately 90%.

 

·                  Patient screening has been initiated in the Phase III trial treating adolescents.

 

Oxtellar XR —Treatment of Bipolar Disorder

 

·                  The Company is planning to initiate pivotal Phase III studies for treatment of bipolar disorder in the second half of 2019.

 

“As we enter the second half of 2018, we remain focused on the successful completion of our clinical programs and look forward to providing top-line data from the first Phase III trial for SPN-812 in the fourth quarter of 2018,” said Jack Khattar.

 

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Operating Expenses

 

Research and development expenses in the second quarter of 2018 were $20.0 million, as compared to $10.8 million in the same quarter last year. The increase was due primarily to the initiation of the four Phase III clinical trials for SPN-812 in the second half of 2017 and to a lesser extent, the open-label extension trials for SPN-812 and SPN-810.

 

Selling, general and administrative expenses in the second quarter of 2018 were $40.1 million, as compared to $35.1 million in the same quarter last year. The increase was due to the expansion of the salesforce by 40 salespeople, which were fully deployed in the fourth quarter of 2017; marketing programs to support the Company’s commercial products; and an increase in share-based compensation.

 

Operating Earnings and Earnings Per Share

 

Operating earnings in the second quarter of 2018 were $35.7 million, a 37.0% increase over $26.1 million in the same period the prior year. The improvement in operating earnings was primarily due to increased net product sales, partially offset by increased operating expenses.

 

GAAP net earnings in the second quarter of 2018 were $30.7 million, as compared to $17.4 million in the same period last year. In addition to higher operating income, GAAP net earnings for the second quarter of 2018 benefited from the reduction in the statutory U.S. federal income tax rate and from stock option exercises.

 

GAAP diluted earnings per share (EPS) were $0.57 in the second quarter of 2018, compared to $0.32 in the second quarter of 2017. Net interest expense and non-cash deferred financing costs associated with the sale of $402.5 million of convertible senior notes in March 2018 had the effect of reducing GAAP net earnings by approximately $4.3 million, or $0.08 per diluted share, in the second quarter of 2018.

 

Weighted-average diluted common shares outstanding were approximately 54.2 million in the second quarter of 2018, as compared to approximately 53.2 million in the second quarter of 2017.

 

As of June 30, 2018, the Company had $677.7 million in cash, cash equivalents, marketable securities and long term marketable securities, as compared to $273.7 million at December 31, 2017. This increase reflects net proceeds of $364.9 million from the issuance of convertible senior notes and warrants, partially offset by purchases of convertible note hedges in March 2018, as well as increased cash from operations in the six months ended June 30, 2018.

 

Financial Guidance

 

For full year 2018, the Company is updating its prior guidance as set forth below:

 

·                  Net product sales in the range of $385 million to $400 million, compared to the previously expected range of $375 million to $400 million.

 

·                  Research and development expenses of approximately $80 million.

 

·                  Operating earnings in the range of $130 million to $140 million, compared to the previously expected range of $125 million to $135 million. The Company continues to expect approximately $7 million of licensing and non-cash royalty revenue.

 

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·                  The Company expects an effective tax rate of approximately 23% to 25% for the third and fourth quarters of 2018.

 

Conference Call Details

 

The Company will hold a conference call hosted by Jack Khattar, President and Chief Executive Officer, and Greg Patrick, Vice President and Chief Financial Officer, to discuss these results at 9:00 a.m. Eastern Time, on Wednesday, August 8, 2018. An accompanying webcast also will be provided.

 

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:

7484048

Conference Call Name:

Supernus Pharmaceuticals Second Quarter 2018 Earnings 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 specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases. The Company currently markets Trokendi XR® (extended-release topiramate) for the prophylaxis of migraine and the treatment of epilepsy, and Oxtellar XR® (extended-release oxcarbazepine) for the treatment of epilepsy. The Company is also developing several product candidates to address large market opportunities in psychiatry, including SPN-810 for the treatment of Impulsive Aggression in ADHD patients and SPN-812 for the treatment of ADHD.

 

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 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

 

4



 

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.

 

5



 

Supernus Pharmaceuticals, Inc.

Consolidated Balance Sheets

(in thousands, except share amounts)

 

 

 

June 30,

 

December 31,

 

 

 

2018

 

2017

 

 

 

(unaudited)

 

 

 

Assets

 

 

 

 

 

Current assets

 

 

 

 

 

Cash and cash equivalents

 

$

35,205

 

$

100,304

 

Marketable securities

 

139,208

 

39,736

 

Accounts receivable, net

 

74,842

 

65,586

 

Inventories, net

 

20,680

 

16,304

 

Prepaid expenses and other current assets

 

14,581

 

6,521

 

Total current assets

 

284,516

 

228,451

 

Long term marketable securities

 

503,312

 

133,638

 

Property and equipment, net

 

4,897

 

5,124

 

Intangible assets, net

 

33,794

 

36,019

 

Other non-current assets

 

752

 

389

 

Deferred income taxes

 

25,528

 

20,843

 

 

 

 

 

 

 

Total assets

 

$

852,799

 

$

424,464

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

 

Current liabilities

 

 

 

 

 

Accounts payable

 

$

2,943

 

$

6,844

 

Accrued sales deductions

 

70,044

 

68,343

 

Accrued expenses

 

29,288

 

27,305

 

Income taxes payable

 

 

15,938

 

Non-recourse liability related to sale of future royalties, current portion   

 

1,659

 

4,283

 

Deferred licensing revenue

 

 

287

 

Total current liabilities

 

103,934

 

123,000

 

Deferred licensing revenue, net of current portion

 

 

1,149

 

Convertible notes, net

 

321,920

 

 

Non-recourse liability related to sale of future royalties, long term

 

23,867

 

22,258

 

Other non-current liabilities

 

12,586

 

10,577

 

Total liabilities

 

462,307

 

156,984

 

 

 

 

 

 

 

Stockholders’ equity

 

 

 

 

 

Common stock, $0.001 par value, 130,000,000 shares authorized at June 30, 2018 and December 31, 2017; 52,179,334 and 51,314,850 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively

 

52

 

51

 

Additional paid-in capital

 

361,971

 

294,999

 

Accumulated other comprehensive loss, net of tax

 

(4,119

)

(747

)

Retained earnings (accumulated deficit)

 

32,588

 

(26,823

)

Total stockholders’ equity

 

390,492

 

267,480

 

 

 

 

 

 

 

Total liabilities and stockholders’ equity

 

$

852,799

 

$

424,464

 

 

6



 

Supernus Pharmaceuticals, Inc.

Consolidated Statements of Earnings

(in thousands, except share and per share data)

 

 

 

Three Months ended June 30,

 

Six Months ended June 30,

 

 

 

2018

 

2017

 

2018

 

2017

 

 

 

(unaudited)

 

(unaudited)

 

Revenue

 

 

 

 

 

 

 

 

 

Net product sales

 

$

97,030

 

$

73,328

 

$

186,150

 

$

129,697

 

Royalty revenue

 

1,758

 

1,179

 

3,067

 

2,328

 

Licensing revenue

 

750

 

1,322

 

750

 

1,380

 

 

 

 

 

 

 

 

 

 

 

Total revenue

 

99,538

 

75,829

 

189,967

 

133,405

 

 

 

 

 

 

 

 

 

 

 

Costs and expenses

 

 

 

 

 

 

 

 

 

Cost of product sales

 

3,683

 

3,861

 

6,961

 

6,809

 

Research and development

 

20,038

 

10,823

 

38,946

 

20,425

 

Selling, general and administrative

 

40,097

 

35,078

 

76,946

 

63,316

 

 

 

 

 

 

 

 

 

 

 

Total costs and expenses

 

63,818

 

49,762

 

122,853

 

90,550

 

 

 

 

 

 

 

 

 

 

 

Operating earnings

 

35,720

 

26,067

 

67,114

 

42,855

 

Other income (expense)

 

 

 

 

 

 

 

 

 

Interest income

 

3,664

 

656

 

4,870

 

1,187

 

Interest expense

 

(4,324

)

(58

)

(5,041

)

(147

)

Interest expense-nonrecourse liability related to sale of future royalties

 

(1,204

)

(160

)

(1,905

)

(1,119

)

Changes in fair value of derivative liabilities

 

 

23

 

 

76

 

Loss on extinguishment of debt

 

 

(103

)

 

(204

)

 

 

 

 

 

 

 

 

 

 

Total other income (expense)

 

(1,864

)

358

 

(2,076

)

(207

)

 

 

 

 

 

 

 

 

 

 

Earnings before income taxes

 

33,856

 

26,425

 

65,038

 

42,648

 

 

 

 

 

 

 

 

 

 

 

Income tax expense

 

3,119

 

9,057

 

7,949

 

14,983

 

 

 

 

 

 

 

 

 

 

 

Net earnings

 

$

30,737

 

$

17,368

 

$

57,089

 

$

27,665

 

 

 

 

 

 

 

 

 

 

 

Earnings per share:

 

 

 

 

 

 

 

 

 

Basic

 

$

0.59

 

$

0.34

 

$

1.10

 

$

0.55

 

Diluted

 

$

0.57

 

$

0.32

 

$

1.06

 

$

0.52

 

 

 

 

 

 

 

 

 

 

 

Weighted-average number of common shares outstanding:

 

 

 

 

 

 

 

 

 

Basic

 

51,919,894

 

50,530,968

 

51,729,243

 

50,345,830

 

Diluted

 

54,203,308

 

53,223,714

 

54,021,941

 

53,026,323

 

 

CONTACTS:

 

Jack A. Khattar, President and CEO

Gregory S. Patrick, Vice President and CFO

Supernus Pharmaceuticals, Inc.

Tel: (301) 838-2591

 

or

 

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INVESTOR CONTACT:

Peter Vozzo

Westwicke Partners

Office: (443) 213-0505

Mobile: (443) 377-4767

Email: peter.vozzo@westwicke.com

 

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