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 |
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20-2590184 |
(Commission File Number) |
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(IRS Employer Identification No.) |
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 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 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 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.
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: August 7, 2018 |
By: |
/s/Gregory S. Patrick |
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Gregory S. Patrick |
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Vice-President and Chief Financial Officer |
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 | |||||||
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Q2 2018 |
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Q2 2017 |
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Change % |
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Trokendi XR |
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177,052 |
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124,089 |
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42.7 |
% |
Oxtellar XR |
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37,789 |
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34,468 |
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9.6 |
% |
Total |
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214,841 |
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158,557 |
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35.5 |
% |
Source: IQVIA
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) | |||||||||
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Q2 2018 |
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Q2 2017 |
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Change % |
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Trokendi XR |
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$ |
76.4 |
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$ |
56.0 |
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36.4 |
% |
Oxtellar XR |
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$ |
20.6 |
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$ |
17.3 |
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19.1 |
% |
Total |
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$ |
97.0 |
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$ |
73.3 |
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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.
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 Companys 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.
· 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 Companys 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 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 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.
Consolidated Balance Sheets
(in thousands, except share amounts)
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June 30, |
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December 31, |
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2018 |
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2017 |
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(unaudited) |
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Assets |
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Current assets |
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Cash and cash equivalents |
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$ |
35,205 |
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$ |
100,304 |
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Marketable securities |
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139,208 |
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39,736 |
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Accounts receivable, net |
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74,842 |
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65,586 |
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Inventories, net |
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20,680 |
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16,304 |
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Prepaid expenses and other current assets |
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14,581 |
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6,521 |
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Total current assets |
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284,516 |
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228,451 |
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Long term marketable securities |
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503,312 |
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133,638 |
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Property and equipment, net |
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4,897 |
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5,124 |
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Intangible assets, net |
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33,794 |
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36,019 |
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Other non-current assets |
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752 |
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389 |
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Deferred income taxes |
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25,528 |
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20,843 |
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Total assets |
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$ |
852,799 |
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$ |
424,464 |
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Liabilities and stockholders equity |
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Current liabilities |
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Accounts payable |
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$ |
2,943 |
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$ |
6,844 |
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Accrued sales deductions |
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70,044 |
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68,343 |
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Accrued expenses |
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29,288 |
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27,305 |
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Income taxes payable |
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15,938 |
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Non-recourse liability related to sale of future royalties, current portion |
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1,659 |
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4,283 |
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Deferred licensing revenue |
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287 |
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Total current liabilities |
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103,934 |
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123,000 |
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Deferred licensing revenue, net of current portion |
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1,149 |
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Convertible notes, net |
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321,920 |
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Non-recourse liability related to sale of future royalties, long term |
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23,867 |
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22,258 |
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Other non-current liabilities |
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12,586 |
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10,577 |
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Total liabilities |
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462,307 |
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156,984 |
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Stockholders equity |
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Common stock, $0.001 par value, 130,000,000 shares authorized at June 30, 2018 and December 31, 2017; 52,179,334 and 51,314,850 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively |
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52 |
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51 |
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Additional paid-in capital |
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361,971 |
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294,999 |
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Accumulated other comprehensive loss, net of tax |
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(4,119 |
) |
(747 |
) | ||
Retained earnings (accumulated deficit) |
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32,588 |
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(26,823 |
) | ||
Total stockholders equity |
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390,492 |
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267,480 |
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Total liabilities and stockholders equity |
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$ |
852,799 |
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$ |
424,464 |
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Supernus Pharmaceuticals, Inc.
Consolidated Statements of Earnings
(in thousands, except share and per share data)
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Three Months ended June 30, |
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Six Months ended June 30, |
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2018 |
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2017 |
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2018 |
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2017 |
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(unaudited) |
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(unaudited) |
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Revenue |
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Net product sales |
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$ |
97,030 |
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$ |
73,328 |
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$ |
186,150 |
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$ |
129,697 |
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Royalty revenue |
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1,758 |
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1,179 |
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3,067 |
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2,328 |
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Licensing revenue |
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750 |
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1,322 |
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750 |
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1,380 |
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Total revenue |
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99,538 |
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75,829 |
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189,967 |
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133,405 |
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Costs and expenses |
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Cost of product sales |
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3,683 |
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3,861 |
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6,961 |
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6,809 |
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Research and development |
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20,038 |
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10,823 |
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38,946 |
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20,425 |
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Selling, general and administrative |
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40,097 |
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35,078 |
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76,946 |
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63,316 |
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Total costs and expenses |
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63,818 |
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49,762 |
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122,853 |
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90,550 |
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Operating earnings |
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35,720 |
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26,067 |
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67,114 |
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42,855 |
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Other income (expense) |
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Interest income |
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3,664 |
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656 |
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4,870 |
|
1,187 |
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Interest expense |
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(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 |
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23 |
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76 |
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Loss on extinguishment of debt |
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(103 |
) |
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(204 |
) | ||||
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Total other income (expense) |
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(1,864 |
) |
358 |
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(2,076 |
) |
(207 |
) | ||||
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Earnings before income taxes |
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33,856 |
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26,425 |
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65,038 |
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42,648 |
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Income tax expense |
|
3,119 |
|
9,057 |
|
7,949 |
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14,983 |
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Net earnings |
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$ |
30,737 |
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$ |
17,368 |
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$ |
57,089 |
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$ |
27,665 |
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Earnings per share: |
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Basic |
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$ |
0.59 |
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$ |
0.34 |
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$ |
1.10 |
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$ |
0.55 |
|
Diluted |
|
$ |
0.57 |
|
$ |
0.32 |
|
$ |
1.06 |
|
$ |
0.52 |
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Weighted-average number of common shares outstanding: |
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|
|
|
|
|
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Basic |
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51,919,894 |
|
50,530,968 |
|
51,729,243 |
|
50,345,830 |
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Diluted |
|
54,203,308 |
|
53,223,714 |
|
54,021,941 |
|
53,026,323 |
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CONTACTS:
Jack A. Khattar, President and CEO
Gregory S. Patrick, Vice President and CFO
Supernus Pharmaceuticals, Inc.
Tel: (301) 838-2591
or