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 2, 2017

 

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 2, 2017, Supernus Pharmaceuticals, Inc. (“Supernus” or the “Company”) issued a press release regarding its financial results for the second quarter ended June 30, 2017. 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 (6:00 a.m. Pacific Time) on Thursday, August 3, 2017, 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 55235874.

 

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 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, 2016, which the Company filed on March 16, 2017.

 

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 2, 2017.

 

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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 2, 2017

By:

/s/ Gregory S. Patrick

 

 

Gregory S. Patrick

 

 

Vice-President and Chief Financial Officer

 

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EXHIBIT INDEX

 

Number

 

Description

 

 

 

 

 

 

 

99.1

 

Press Release Dated August 2, 2017.

 

Attached

 

4


Exhibit 99.1

 

 

Supernus Announces Record Second Quarter 2017 Financial Results

 

·                  Second quarter net product sales were $73.3 million, a 46% increase over 2016.

 

·                  Strong acceleration in Trokendi XR prescription growth following April launch in migraine prophylaxis in adults and adolescents.

 

·                  Second quarter operating income was $26.1 million, a 124% increase over 2016.

 

·                  Raising full year 2017 financial guidance for net product sales by $15 million and operating income by $7 million.

 

·                  Phase III trials for SPN-812 to start second half 2017, following recent end-of-Phase II meeting with FDA.

 

Rockville, Md., August 2, 2017 - 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 financial results for second quarter 2017 and associated company developments.

 

Commercial Update

 

Second quarter 2017 product prescriptions for Trokendi XR® and Oxtellar XR®, as reported by IMS, totaled 158,752, a 28.1% increase over the second quarter of 2016.

 

 

 

Prescriptions

 

 

 

 

 

Q2 2017

 

Q2 2016

 

Change %

 

Trokendi XR

 

124,229

 

93,223

 

33.3

%

Oxtellar XR

 

34,523

 

30,726

 

12.4

%

Total

 

158,752

 

123,949

 

28.1

%

 

Source:  IMS

 

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Net product sales for the second quarter of 2017 were $73.3 million, a 45.7% increase over $50.3 million in the same period the prior year.

 

 

 

Net Product Sales ($mil.)

 

 

 

 

 

Q2 2017

 

Q2 2016

 

Change %

 

Trokendi XR

 

$

56.0

 

$

37.6

 

48.9

%

Oxtellar XR

 

$

17.3

 

$

12.7

 

36.2

%

Total

 

$

73.3

 

$

50.3

 

45.7

%

 

Trokendi XR Migraine Launch

 

In April 2017, the Company launched Trokendi XR as a new treatment for prophylaxis of migraine headache in adults and adolescents 12 years and older. Since launch, IMS prescription data for Trokendi XR has shown robust acceleration in prescription growth.

 

For the second quarter of 2017, total prescriptions for Trokendi XR increased by 22.2% from the first quarter of 2017. This compares to an increase of 8.1% in the second quarter of 2016 over the first quarter of 2016. Similarly, for the same sequential quarter-to-quarter time periods, new prescriptions for Trokendi XR increased by 31.2% in 2017, compared to 5.8% in 2016.

 

 

 

Prescription Growth Compared to Q1

 

 

 

Q2 2017

 

Q2 2016

 

 

 

Prescriptions

 

Change %

 

Prescriptions

 

Change %

 

Trokendi XR - Total

 

22,534

 

22.2

%

6,996

 

8.1

%

Trokendi XR - New

 

14,594

 

31.2

%

2,352

 

5.8

%

 

Source:  IMS

 

“We are very pleased with the launch of Trokendi XR in migraine prophylaxis, which we believe is a reflection of the positive feedback we have recently received from physicians because of the clinical benefits Trokendi XR offers to patients,” said Jack Khattar, President and CEO of Supernus Pharmaceuticals.

 

“As a result of the continued strong launch and the outstanding performance of our sales organization, we plan to expand our salesforce by approximately 40 sales representatives by the fourth quarter of 2017. The expanded salesforce will consist of more than 200 sales representatives in total and will provide additional support to both Trokendi XR and Oxtellar XR,” said Jack Khattar.

 

Progress of Product Pipeline

 

Enrollment continues in both Phase III trials for SPN-810, currently in development for Impulsive Aggression in patients aged 6 to 12 years who have ADHD. Enrollment into the Phase III trials has shown steady progress as a result of the protocol revisions and programs implemented to improve patient retention and drive patient enrollment. Enrollment is at approximately 60% and 50% of target patient enrollment in the first and second trials, respectively. The Company expects enrollment to continue through mid-2018. The Company is also discussing with the U.S. Food and Drug Administration (FDA) expanding the program to include the adolescent population.

 

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Regarding SPN-812, the Company continues to plan to initiate Phase III clinical testing during the second half of 2017 following a meeting with the FDA in June 2017. The Company is finalizing its protocols that include the pediatric and adolescent patient populations.

 

The Oxtellar XR investigator-sponsored trial in bipolar disorder is also on track to start in the third quarter of 2017.

 

Operating Expenses

 

Research and development expenses in the second quarter of 2017 were $10.8 million, as compared to $11.1 million in the same quarter last year. This decrease is primarily due to the completion of enrollment in 2016 of the Phase IIb trial for SPN-812.

 

Selling, general and administrative expenses in the second quarter of 2017 were $35.1 million, as compared to $26.1 million in the same quarter last year. The increase is primarily due to promotional activities and programs related to the April 2017 launch of the migraine headache indication for Trokendi XR.

 

Operating Income and Earnings Per Share

 

Operating income in the second quarter of 2017 was $26.1 million, a 123.8% increase over $11.6 million in the same period the prior year. This improvement in operating income is primarily due to increased net product sales, partially offset by increased selling, general and administrative expenses.

 

Diluted earnings per share for the second quarter of 2017 were $0.32 compared to $0.18 in the same period last year, an increase of 77.8% over the prior year. Diluted earnings per share for the second quarter of 2017 reflects an effective tax rate of 34.3%, as compared to an effective tax rate of 3.8% during the second quarter of 2016.

 

Weighted-average diluted common shares outstanding were approximately 53.2 million in the second quarter of 2017, as compared to approximately 51.7 million in the same period the prior year.

 

Capital Resources

 

As of June 30, 2017, the Company had $197.6 million in cash, cash equivalents, marketable securities, and long term marketable securities, as compared to $165.5 million at December 31, 2016. As of July 31, 2017, the Company had fully converted all of its outstanding notes.

 

Financial Guidance

 

For full year 2017, the Company is raising its expectations for both net product sales and operating income, and reiterating its expectation for research and development expense as set forth below:

 

·                  Net product sales in the range of $280 million to $290 million, or $15 million higher than the previously expected range of $265 million to $275 million.

 

·                  Research and development expense of approximately $55 million.

 

·                  Operating income in the range of $82 million to $87 million, or $7 million higher than the previously expected range of $75 million to $80 million. The Company continues to expect that full year 2017 operating income will include approximately $5 million of non-cash royalty revenue.

 

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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. ET, on Thursday, August 3, 2017. 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:

 

55235874

Conference Call Name:

 

Supernus Pharmaceuticals Second Quarter 2017 Earnings Conference Call

 

Following the live call, a replay will be available on the Company’s website, www.supernus.com, under ‘Investors’.

 

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 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

 

4



 

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 SEC filings 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.

Consolidated Balance Sheets

(in thousands)

 

 

 

June 30, 2017

 

December 31, 2016

 

 

 

(unaudited)

 

 

 

 

 

 

 

 

 

Cash, cash equivalents and marketable securities

 

$

92,966

 

$

90,121

 

Accounts receivable, net

 

51,157

 

41,527

 

Inventories, net

 

16,623

 

16,801

 

Prepaid expenses and other current assets

 

4,746

 

2,955

 

Total current assets

 

165,492

 

151,404

 

 

 

 

 

 

 

Long term marketable securities

 

104,632

 

75,410

 

Property and equipment, net

 

4,572

 

4,344

 

Deferred legal fees

 

11,887

 

19,860

 

Intangible assets, net

 

28,989

 

16,490

 

Other non-current assets

 

349

 

331

 

Deferred income tax

 

30,449

 

41,729

 

 

 

 

 

 

 

Total assets

 

$

346,370

 

$

309,568

 

 

 

 

 

 

 

Accounts payable

 

$

7,577

 

$

8,055

 

Accrued sales deductions

 

47,621

 

41,943

 

Accrued expenses

 

23,434

 

27,427

 

Accrued income taxes payable

 

1,608

 

7

 

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

 

4,997

 

3,101

 

Deferred licensing revenue

 

287

 

209

 

Total current liabilities

 

85,524

 

80,742

 

 

 

 

 

 

 

Deferred licensing revenue, net of current portion

 

1,293

 

1,501

 

Convertible notes, net

 

1,472

 

4,165

 

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

 

24,184

 

27,289

 

Other non-current liabilities

 

4,500

 

4,002

 

Derivative liabilities

 

 

114

 

Total liabilities

 

116,973

 

117,813

 

 

 

 

 

 

 

Total stockholders’ equity

 

229,397

 

191,755

 

 

 

 

 

 

 

Total liabilities and stockholders’ equity

 

$

346,370

 

$

309,568

 

 

5



 

Supernus Pharmaceuticals, Inc.

Consolidated Statements of Operations

(in thousands, except share and per share data)

 

 

 

Three Months ended June 30,

 

Six Months ended June 30,

 

 

 

2017

 

2016

 

2017

 

2016

 

 

 

(unaudited)

 

(unaudited)

 

Revenue

 

 

 

 

 

 

 

 

 

Net product sales

 

$

73,328

 

$

50,335

 

$

129,697

 

$

93,360

 

Royalty revenue

 

1,179

 

1,205

 

2,328

 

2,324

 

Licensing revenue

 

1,322

 

86

 

1,380

 

135

 

 

 

 

 

 

 

 

 

 

 

Total revenue

 

75,829

 

51,626

 

133,405

 

95,819

 

 

 

 

 

 

 

 

 

 

 

Costs and expenses

 

 

 

 

 

 

 

 

 

Cost of product sales

 

3,861

 

2,751

 

6,809

 

4,786

 

Research and development

 

10,823

 

11,109

 

20,425

 

21,671

 

Selling, general and administrative

 

35,078

 

26,121

 

63,316

 

51,281

 

 

 

 

 

 

 

 

 

 

 

Total costs and expenses

 

49,762

 

39,981

 

90,550

 

77,738

 

 

 

 

 

 

 

 

 

 

 

Operating income

 

26,067

 

11,645

 

42,855

 

18,081

 

 

 

 

 

 

 

 

 

 

 

Other income (expense)

 

 

 

 

 

 

 

 

 

Interest income

 

656

 

365

 

1,187

 

693

 

Interest expense

 

(58

)

(196

)

(147

)

(375

)

Interest expense-nonrecourse liability related to sale of future royalties

 

(160

)

(1,281

)

(1,119

)

(2,560

)

Changes in fair value of derivative liabilities

 

23

 

123

 

76

 

224

 

Loss on extinguishment of debt

 

(103

)

 

(204

)

(382

)

 

 

 

 

 

 

 

 

 

 

Total other income (expense)

 

358

 

(989

)

(207

)

(2,400

)

 

 

 

 

 

 

 

 

 

 

Earnings before income taxes

 

26,425

 

10,656

 

42,648

 

15,681

 

 

 

 

 

 

 

 

 

 

 

Income tax expense

 

9,057

 

405

 

14,983

 

605

 

 

 

 

 

 

 

 

 

 

 

Net income

 

$

17,368

 

$

10,251

 

$

27,665

 

$

15,076

 

 

 

 

 

 

 

 

 

 

 

Income per common share:

 

 

 

 

 

 

 

 

 

Basic

 

$

0.34

 

$

0.21

 

$

0.55

 

$

0.31

 

Diluted

 

$

0.32

 

$

0.18

 

$

0.52

 

$

0.28

 

 

 

 

 

 

 

 

 

 

 

Weighted-average number of common shares:

 

 

 

 

 

 

 

 

 

Basic

 

50,530,968

 

49,427,825

 

50,345,830

 

49,333,962

 

Diluted

 

53,223,714

 

51,745,342

 

53,026,323

 

51,484,686

 

 

6



 

CONTACTS:

 

Jack A. Khattar, President and CEO

Gregory S. Patrick, Vice President and CFO

Supernus Pharmaceuticals, Inc.

Tel: (301) 838-2591

 

or

 

INVESTOR CONTACT:

Peter Vozzo

Westwicke Partners

Office: (443) 213-0505

Mobile: (443) 377-4767

Email: peter.vozzo@westwicke.com

 

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