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): May 9, 2017
Supernus Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Delaware |
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(State or other jurisdiction of |
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001-35518 |
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20-2590184 |
(Commission File Number) |
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(IRS Employer Identification No.) |
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1550 East Gude Drive, Rockville MD |
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20850 |
(Address of principal executive offices) |
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(Zip Code) |
Registrants 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 May 9, 2017, Supernus Pharmaceuticals, Inc. (Supernus or the Company) issued a press release regarding its financial results for the first quarter ended March 31, 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 Wednesday, May 10, 2017, to present the financial results. A live webcast will be available at www.supernus.com. The webcast will be archived on the Companys 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 9981751.
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 (the Exchange Act) 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, or the Exchange Act, 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 May 9, 2017.
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.
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SUPERNUS PHARMACEUTICALS, INC. | |
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DATED: May 9, 2017 |
By: |
/s/ Gregory S. Patrick |
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Gregory S. Patrick |
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Vice-President and Chief Financial Officer |
Exhibit 99.1
Supernus Announces First Quarter 2017 Financial Results
· Net product sales were $56.4 million, a 31% increase over 2016.
· Operating income was $16.8 million, a 161% increase over 2016.
· Diluted earnings per share were $0.19, increasing by 138% over 2016.
· Early prescription data for Trokendi XR show a strong upward trend following launch in migraine prophylaxis in adults and adolescents.
Rockville, Md., May 9, 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 first quarter 2017 and associated company developments.
Commercial Update
First quarter 2017 product prescriptions for Trokendi XR® and Oxtellar XR®, as reported by IMS, totaled 134,855, a 17.1% increase over the first quarter of 2016.
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Prescriptions |
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Q1 2017 |
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Q1 2016 |
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Change % |
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Trokendi XR |
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101,695 |
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86,227 |
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17.9 |
% |
Oxtellar XR |
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33,160 |
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28,913 |
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14.7 |
% |
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Total |
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134,855 |
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115,140 |
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17.1 |
% |
Source: IMS
Net product sales for the first quarter of 2017 were $56.4 million, a 31.2% increase over $43.0 million in the same period the prior year.
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Net Product Sales ($mil.) |
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Q1 2017 |
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Q1 2016 |
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Change % |
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Trokendi XR |
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$ |
42.0 |
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$ |
32.3 |
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30.0 |
% |
Oxtellar XR |
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$ |
14.4 |
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$ |
10.7 |
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34.6 |
% |
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Total |
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$ |
56.4 |
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$ |
43.0 |
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31.2 |
% |
Consistent with historical patterns, product prescriptions and net product sales for the first quarter of 2017 for Trokendi XR and Oxtellar XR were impacted by the continued shift of patients to high deductible and high co-pay plans. Lower wholesaler and pharmacy inventory levels during the first quarter of 2017, compared to the fourth quarter of 2016, had the effect of reducing net product sales by approximately $5 million in the first quarter of 2017.
Trokendi XR Migraine Launch
After receiving final approval from the Food and Drug Administration (FDA) 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.
While it is still early in the launch, for the first three weeks post launch, IMS prescription data for Trokendi XR show a strong upward trend in total and new prescriptions. During the three week period post launch, total prescriptions were 26,472 compared to 24,109 in the three weeks prior to launch, representing a 10% increase. Similarly, for the same three week period post launch, new prescriptions were 12,978 compared to 10,898 in the three weeks prior to launch, representing a 19% increase. Consistent with these early data, feedback from our sales force indicates that physicians are very receptive to the new indication and appreciate the unique benefits that Trokendi XR brings to migraine patients.
We are excited about the launch of Trokendi XR in migraine, and are very encouraged by the early IMS prescription data. We continue to believe that the migraine indication should allow us to realize the full potential of Trokendi XR, said Jack Khattar, President and CEO of Supernus Pharmaceuticals. Trokendi XR, with its novel formulation, provides full 24 hour coverage for patients with smooth pharmacokinetics compared to immediate-release topiramate products, making it an important new prophylactic treatment option for adult and adolescent patients suffering from migraine headache.
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. Protocol revisions to improve patient retention during the screening period and programs to drive patient enrollment for the Phase III trials are having a positive impact. We expect enrollment to continue through 2017.
Regarding SPN-812, currently in development for patients aged 6 to 12 years with ADHD, the Company continues to plan to initiate Phase III clinical testing during the second half of 2017. The Company is on track to meet with the FDA in the second quarter of 2017 for an end-of-Phase II meeting.
We look forward to discussing further with the FDA our Phase IIb clinical trial results and the design of our Phase III program for SPN-812, said Jack Khattar. We remain focused on advancing SPN-812 as a novel highly effective and well tolerated non-stimulant for the treatment of ADHD.
Operating Expenses
Research and development expenses in the first quarter of 2017 were $9.6 million, as compared to $10.6 million in the same quarter last year. This decrease is primarily due to the completion of enrollment in the Phase IIb trial for SPN-812, which occurred in the third quarter of 2016.
Selling, general and administrative expenses in the first quarter of 2017 were $28.2 million, as compared to $25.2 million in the same quarter last year. The increase is due to marketing
program development, sample production, and other activities related to preparing for the launch of the migraine headache indication for Trokendi XR, which occurred in April 2017.
Operating Income and Earnings Per Share
Operating income in the first quarter of 2017 was $16.8 million, a 160.8% increase over $6.4 million in the same period the prior year. This improvement in operating income is primarily due to increased net product sales.
Diluted earnings per share for the first quarter of 2017 were $0.19 compared to $0.08 in the same period last year, an increase of 138% over the prior year. Diluted earnings per share for the first quarter of 2017 includes an effective tax rate of 36.5%, as compared to an effective tax rate of 4.0% during the first quarter of 2016.
Weighted-average diluted common shares outstanding were approximately 52.8 million in the first quarter of 2017, as compared to approximately 51.2 million in the same period the prior year.
Capital Resources
As of March 31, 2017, the Company had $176.3 million in cash, cash equivalents, marketable securities, and long term marketable securities, as compared to $165.5 million at December 31, 2016. As of May 8, 2017, approximately $1.6 million of the Companys six year, $90 million notes remain outstanding. During the second quarter of 2017, the Company initiated the process of calling the remaining outstanding principal balance of its six year notes and expects that process to be completed in the quarter.
Financial Guidance
For full year 2017, the Company reiterates its expectation for 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. Full year 2017 operating income includes approximately $5 million of non-cash royalty revenue.
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, May 10, 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: |
9981751 |
Conference Call Name: |
Supernus Pharmaceuticals First Quarter 2017 Earnings Conference Call |
Following the live call, a replay will be available on the Companys 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 treatment of migraine and epilepsy and Oxtellar XR® (extended-release oxcarbazepine) for 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 managements 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 Companys ability to sustain and increase its profitability; the Companys ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Companys corporate strategy; the Companys future financial performance and projected expenditures; the Companys ability to increase the number of prescriptions written for each of its products; the Companys ability to increase its net revenue; the Companys ability to enter into future collaborations with pharmaceutical companies and academic institutions or to obtain funding from government agencies; the Companys product research and development activities, including the timing and progress of the Companys clinical trials, and projected expenditures; the Companys ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Companys product candidates; the Companys ability to protect its intellectual property and operate its business without infringing upon the intellectual property rights of others; the Companys expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Companys product candidates; the accuracy of the Companys estimates of the size and characteristics of the markets that may be addressed by its product candidates; the Companys ability to increase its manufacturing capabilities for its products and product candidates; the Companys projected markets and growth in markets; the Companys product formulations and patient needs and potential funding sources; the Companys staffing needs; and other risk factors set forth from time to time in the Companys 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)
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March 31, 2017 |
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December 31, 2016 |
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(unaudited) |
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Cash, cash equivalents and marketable securities |
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$ |
87,132 |
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$ |
90,121 |
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Accounts receivable, net |
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38,885 |
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41,527 |
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Inventories, net |
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19,167 |
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16,801 |
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Prepaid expenses and other current assets |
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4,573 |
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2,955 |
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Total current assets |
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149,757 |
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151,404 |
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Long term marketable securities |
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89,163 |
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75,410 |
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Property and equipment, net |
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4,342 |
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4,344 |
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Deferred legal fees |
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11,331 |
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19,860 |
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Intangible assets, net |
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29,450 |
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16,490 |
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Other non-current assets |
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350 |
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331 |
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Deferred income tax |
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37,863 |
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41,729 |
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Total assets |
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$ |
322,256 |
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$ |
309,568 |
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Accounts payable |
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$ |
5,056 |
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$ |
8,055 |
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Accrued sales deductions |
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43,450 |
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41,943 |
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Accrued expenses |
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26,890 |
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27,427 |
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Accrued income taxes payable |
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1,675 |
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7 |
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Non-recourse liability related to sale of future royalties, current portion |
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4,645 |
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3,101 |
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Deferred licensing revenue |
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287 |
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209 |
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Total current liabilities |
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82,003 |
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80,742 |
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Deferred licensing revenue, net of current portion |
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1,365 |
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1,501 |
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Convertible notes, net |
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3,310 |
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4,165 |
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Non-recourse liability related to sale of future royalties, long term |
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25,555 |
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27,289 |
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Other non-current liabilities |
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3,936 |
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4,002 |
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Derivative liabilities |
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23 |
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114 |
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Total liabilities |
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116,192 |
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117,813 |
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Total stockholders equity |
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206,064 |
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191,755 |
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Total liabilities and stockholders equity |
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$ |
322,256 |
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$ |
309,568 |
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Supernus Pharmaceuticals, Inc.
Consolidated Statements of Operations
(in thousands, except share and per share data)
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Three Months Ended March 31, |
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2017 |
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2016 |
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(unaudited) |
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Revenue |
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Net product sales |
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$ |
56,369 |
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$ |
43,025 |
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Royalty revenue |
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1,149 |
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1,119 |
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Licensing revenue |
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58 |
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50 |
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Total revenue |
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57,576 |
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44,194 |
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Costs and expenses |
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Cost of product sales |
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2,949 |
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2,035 |
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Research and development |
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9,601 |
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10,562 |
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Selling, general and administrative |
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28,238 |
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25,160 |
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Total costs and expenses |
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40,788 |
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37,757 |
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Operating income |
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16,788 |
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6,437 |
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Other income (expense) |
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Interest income |
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531 |
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327 |
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Interest expense |
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(90 |
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(179 |
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Interest expense-nonrecourse liability related to sale of future royalties |
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(959 |
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(1,279 |
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Changes in fair value of derivative liabilities |
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54 |
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101 |
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Loss on extinguishment of debt |
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(101 |
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(382 |
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Total other expense |
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(565 |
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(1,412 |
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Earnings before income taxes |
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16,223 |
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5,025 |
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Income tax expense |
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5,926 |
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200 |
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Net income |
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$ |
10,297 |
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$ |
4,825 |
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Income per common share: |
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Basic |
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$ |
0.21 |
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$ |
0.10 |
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Diluted |
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$ |
0.19 |
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$ |
0.08 |
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Weighted-average number of common shares outstanding: |
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Basic |
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50,158,634 |
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49,240,099 |
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Diluted |
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52,764,442 |
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51,152,072 |
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