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8-K - 8-K - SUPERNUS PHARMACEUTICALS, INC.a17-7367_18k.htm
EX-99.2 - EX-99.2 - SUPERNUS PHARMACEUTICALS, INC.a17-7367_1ex99d2.htm

Exhibit 99.1

 

 

Supernus Announces Record Fourth Quarter and Full Year 2016 Financial Results

 

·                  Fourth quarter 2016 net product sales were $61.1 million, a 43% increase over 2015.

 

·                  Fourth quarter operating income was $16.3 million, a 107% increase over 2015.

 

·                  Fourth quarter diluted earnings per share were $0.26, an 86% increase over 2015.

 

·                  Full year 2016 net product sales were $210.1 million, a 46% increase over 2015.

 

·                  Full year 2016 operating income was $54.2 million, a 160% increase over 2015.

 

·                  Full year 2016 diluted earnings per share were $1.76 compared to $0.28 in 2015.

 

Rockville, Md., February 28, 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 fourth quarter and full year 2016 and associated Company developments.

 

Commercial Update

 

Fourth quarter 2016 product prescriptions for Trokendi XR® and Oxtellar XR®, as reported by IMS, totaled 136,145, a 22.0% increase over the fourth quarter of 2015. Full year 2016 product prescriptions for Trokendi XR and Oxtellar XR totaled 506,542, a 33.9% increase over full year 2015.

 

 

 

Prescriptions

 

 

 

Prescriptions

 

 

 

 

 

Q4 2016

 

Q4 2015

 

Change %

 

FY 2016

 

FY 2015

 

Change %

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Trokendi XR

 

102,727

 

83,899

 

22.4

%

381,226

 

279,782

 

36.3

%

Oxtellar XR

 

33,418

 

27,728

 

20.5

%

125,316

 

98,391

 

27.4

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total

 

136,145

 

111,627

 

22.0

%

506,542

 

378,173

 

33.9

%

 

Source:  IMS

 

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Net product sales for the fourth quarter of 2016 were $61.1 million, a 43.4% increase over $42.6 million in the same period the prior year. Net product sales for full year 2016 were $210.1 million, a 46.4% increase over $143.5 million in 2015.

 

 

 

Net Product Sales ($mil.)

 

 

 

Net Product Sales ($mil.)

 

 

 

 

 

Q4 2016

 

Q4 2015

 

Change %

 

FY 2016

 

FY 2015

 

Change %

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Trokendi XR

 

$

46.7

 

$

33.3

 

40.3

%

$

158.4

 

$

110.3

 

43.6

%

Oxtellar XR

 

$

14.4

 

$

9.3

 

54.7

%

$

51.7

 

$

33.2

 

55.7

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total

 

$

61.1

 

$

42.6

 

43.4

%

$

210.1

 

$

143.5

 

46.4

%

 

In August 2016, the Food and Drug Administration (FDA) granted tentative approval to the Company’s Supplemental New Drug Application requesting a label expansion for Trokendi XR to include prophylaxis of migraine headache in adults. The Company plans to launch the migraine indication soon after receiving full FDA approval, which the Company anticipates in the second quarter of 2017.

 

“2016 was another year of strong commercial performance with full year net product sales growth of 46% and an increase in operating income of 160% over full year 2015”, said Jack Khattar, President and CEO of Supernus Pharmaceuticals. “This growth was achieved while we continued to advance our pipeline and prepare for the launch of the migraine indication for Trokendi XR.”

 

Khattar added, “In addition, we continued to vigorously defend our novel products and build upon our strong intellectual property position, as evidenced by the favorable court rulings on Oxtellar XR and the issuance of four U.S. patents for Trokendi XR and Oxtellar XR over the past 12 months. We have established a solid foundation for sustainable growth, and we expect 2017 to be another year of strong net product sales and operating income growth.”

 

Progress of Product Pipeline

 

Enrollment continues in both Phase III trials for SPN-810, which is currently in development for Impulsive Aggression in patients aged 6 to 12 years who have ADHD. Steps taken in the second half of 2016 to facilitate identifying, contacting, and prescreening appropriate patients, as well as educating patient caregivers, have increased patient enrollment. In addition, the Company has received FDA approval for revisions to the Phase III protocol, which are expected to improve patient retention during the screening period and in turn improve patient enrollment. Enrollment is expected to continue through 2017.

 

Regarding SPN-812, currently in development for patients aged 6 to 12 years with ADHD, the Company announced in October 2016 positive topline results from its Phase IIb clinical trial in children with ADHD. Supernus plans to have an end-of-Phase II meeting with the FDA, most likely in the second quarter of 2017, after which it will initiate Phase III clinical testing during the second half of 2017.

 

“We continued to advance our two late-stage clinical products in 2016, including achieving positive results from our Phase IIb clinical trial for SPN-812 and increasing enrollment during the second half of 2016 in the Phase III clinical trials for SPN-810,” said Jack Khattar. “We are also excited about our plan that is underway to initiate in 2017 an exploratory trial investigating Oxtellar XR in patients with bipolar disorder. This would be another step towards realizing the full potential of Oxtellar XR in the treatment of patients with psychiatric and neurological disorders.”

 

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Collaboration Update

 

Shire announced that SHP-465 for the treatment of ADHD is expected to be launched in the second half of 2017 after SHP-465 receives FDA approval, which is expected on or around June 20, 2017. Based on the agreement between Supernus and Shire, Shire will pay to Supernus a single-digit percentage royalty on net sales of the product.

 

Operating Expenses

 

Research and development expenses in the fourth quarter of 2016 were $13.3 million, as compared to $9.4 million in the same quarter last year, and, for the full year, $42.8 million, as compared to $29.1 million for 2015. The increases in both periods are primarily due to increased costs associated with the Phase III trials for SPN-810, which were initiated during the third quarter of 2015; increased costs associated with the Phase IIb trial for SPN-812, which was initiated during the fourth quarter of 2015; and the open-label extension studies associated with both product candidates.

 

Selling, general and administrative expenses in the fourth quarter of 2016 were $29.1 million, as compared to $23.6 million in the same quarter last year, and, for the full year, $106.0 million as compared to $89.1 million in 2015. The increases in both periods are primarily due to work done in anticipation of launching the migraine headache indication for Trokendi XR, including marketing program development and sample production.

 

Operating Income, Cash Flows From Operations, and Earnings Per Share

 

Operating income in the fourth quarter of 2016 was $16.3 million, a 106.8% increase over $7.9 million in the same period the prior year. Operating income in full year 2016 was $54.2 million, a 160.1% increase over $20.8 million for full year 2015. This improvement in operating income for both periods is primarily due to increased net product sales.

 

Diluted earnings per share for the fourth quarter of 2016 were $0.26 compared to $0.14 in the same period last year. Diluted earnings per share were $1.76 in 2016, compared to diluted earnings per share of $0.28 in 2015. Diluted earnings per share in 2016 were favorably impacted by the release of the valuation allowance against deferred tax assets, which resulted in a full year 2016 income tax benefit of $40.9 million.

 

Weighted-average diluted common shares outstanding were approximately 52.0 million and 51.7 million in the fourth quarter and full year of 2016, respectively, as compared to approximately 51.2 million in each of the respective periods the prior year.

 

Cash generated from operations for full year 2016 was $66.8 million, as compared to $34.5 million for full year 2015.

 

Capital Resources

 

As of December 31, 2016, the Company had $165.5 million in cash, cash equivalents, marketable securities, and long term marketable securities, as compared to $117.2 million at December 31, 2015.  As of February 28, 2017, approximately $3.6 million of the Company’s six year, $90 million notes remain outstanding.

 

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Financial Guidance

 

For full year 2017, the Company estimates net product sales, R&D expenses and operating income as set forth below:

 

·                  Net product sales in the range of $265 million to $275 million.

 

·                  Research and development expense of approximately $55 million.

 

·                  Operating income in the range of $75 million to $80 million. This includes approximately $5 million of non-cash royalty revenue.

 

Annual Report on Form 10-K Filing Update

 

In fiscal year 2016, the Company became a large accelerated filer pursuant to the Securities Exchange Act of 1934. Consequently, the Company has a shortened filing deadline of 60 days rather than 75 days, and is unable to timely file its Annual Report on Form 10-K for the fourth quarter and full year ended December 31, 2016.  Accordingly, the Company will timely file a Notification of Late Filing on Form 12b-25. The Company’s delay in filing the Form 10-K is due principally to the need to complete all steps and tasks necessary to finalize the Company’s annual financial statements and other disclosures required to be in the filing, including, for the first time, the requirements as a consequence of becoming subject to Section 404(b) of the Sarbanes-Oxley Act of 2002.

 

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 Wednesday, March 1, 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:

70744734

Conference Call Name:

Supernus Pharmaceuticals Fourth Quarter and Full Year 2016 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 has two marketed products for epilepsy, Oxtellar XR® (extended-release oxcarbazepine) and Trokendi XR® (extended-release topiramate). 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.

 

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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 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.

 

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Supernus Pharmaceuticals, Inc.

Consolidated Balance Sheets

(in thousands)

 

 

 

December 31, 2016

 

December 31, 2015

 

 

 

(unaudited)

 

 

 

 

 

 

 

 

 

Cash, cash equivalents and marketable securities

 

$

90,121

 

$

62,190

 

Accounts receivable, net

 

41,527

 

25,908

 

Inventories, net

 

16,801

 

12,587

 

Prepaid expenses and other current assets

 

2,955

 

5,261

 

Total current assets

 

151,404

 

105,946

 

 

 

 

 

 

 

Long term marketable securities

 

75,410

 

55,009

 

Property and equipment, net

 

4,344

 

3,874

 

Deferred legal fees

 

19,860

 

22,503

 

Intangible assets, net

 

16,490

 

976

 

Other non-current assets

 

331

 

318

 

Deferred income tax

 

41,729

 

 

 

 

 

 

 

 

Total assets

 

$

309,568

 

$

188,626

 

 

 

 

 

 

 

Accounts payable

 

$

8,055

 

$

4,314

 

Accrued sales deductions

 

41,943

 

26,794

 

Accrued expenses

 

27,434

 

25,153

 

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

 

3,101

 

497

 

Deferred licensing revenue

 

209

 

176

 

Total current liabilities

 

80,742

 

56,934

 

 

 

 

 

 

 

Deferred licensing revenue, net of current portion

 

1,501

 

1,390

 

Convertible notes, net

 

4,165

 

7,085

 

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

 

27,289

 

30,031

 

Other non-current liabilities

 

4,002

 

4,325

 

Derivative liabilities

 

114

 

854

 

Total liabilities

 

117,813

 

100,619

 

 

 

 

 

 

 

Total stockholders’ equity

 

191,755

 

88,007

 

 

 

 

 

 

 

Total liabilities and stockholders’ equity

 

$

309,568

 

$

188,626

 

 

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Supernus Pharmaceuticals, Inc.

Consolidated Statements of Operations

(in thousands, except share and per share data)

 

 

 

Three Months Ended December 31,

 

Year Ended December 31,

 

 

 

2016

 

2015

 

2016

 

2015

 

 

 

(unaudited)

 

(unaudited)

 

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenue

 

 

 

 

 

 

 

 

 

Net product sales

 

$

61,100

 

$

42,612

 

$

210,078

 

$

143,526

 

Royalty revenue

 

1,222

 

1,031

 

4,686

 

3,038

 

Licensing revenue

 

52

 

44

 

239

 

901

 

 

 

 

 

 

 

 

 

 

 

Total revenue

 

62,374

 

43,687

 

215,003

 

147,465

 

 

 

 

 

 

 

 

 

 

 

Costs and expenses

 

 

 

 

 

 

 

 

 

Cost of product sales

 

3,771

 

2,795

 

11,986

 

8,423

 

Research and development

 

13,252

 

9,445

 

42,791

 

29,135

 

Selling, general and administrative

 

29,055

 

23,566

 

106,010

 

89,063

 

 

 

 

 

 

 

 

 

 

 

Total costs and expenses

 

46,078

 

35,806

 

160,787

 

126,621

 

 

 

 

 

 

 

 

 

 

 

Operating income

 

16,296

 

7,881

 

54,216

 

20,844

 

Other income (expense)

 

 

 

 

 

 

 

 

 

Interest income

 

409

 

224

 

1,482

 

643

 

Interest expense

 

33

 

(225

)

(543

)

(1,229

)

Interest expense-nonrecourse liability related to sale of future royalties

 

(984

)

(1,011

)

(4,548

)

(3,541

)

Changes in fair value of derivative liabilities

 

100

 

127

 

448

 

193

 

Loss on extinguishment of debt

 

(289

)

62

 

(671

)

(2,338

)

Other (expense) income

 

(13

)

8

 

(15

)

38

 

 

 

 

 

 

 

 

 

 

 

Total other expense

 

(744

)

(815

)

(3,847

)

(6,234

)

 

 

 

 

 

 

 

 

 

 

Earnings before income taxes

 

15,552

 

7,066

 

50,369

 

14,610

 

 

 

 

 

 

 

 

 

 

 

Income tax expense (benefit)

 

1,232

 

213

 

(40,852

)

666

 

 

 

 

 

 

 

 

 

 

 

Net income

 

$

14,320

 

$

6,853

 

$

91,221

 

$

13,944

 

 

 

 

 

 

 

 

 

 

 

Income per common share:

 

 

 

 

 

 

 

 

 

Basic

 

$

0.29

 

$

0.14

 

$

1.84

 

$

0.29

 

Diluted

 

$

0.26

 

$

0.14

 

$

1.76

 

$

0.28

 

 

 

 

 

 

 

 

 

 

 

Weighted-average number of common shares outstanding:

 

 

 

 

 

 

 

 

 

Basic

 

49,702,207

 

48,891,847

 

49,472,434

 

47,485,258

 

Diluted

 

52,020,596

 

49,598,030

 

51,708,983

 

51,160,380

 

 

 

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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