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, 2016
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) |
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))
Item 2.02 Results of Operations and Financial Condition.
On August 2, 2016, Supernus Pharmaceuticals, Inc. (Supernus or the Company) issued a press release regarding its financial results for the second quarter ended June 30, 2016. A copy of this release is attached hereto as Exhibit 99.1 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, August 3, 2016, 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 50720151.
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 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, 2015, which the Company filed on March 9, 2016.
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, 2016.
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. | |
|
|
|
DATED: August 2, 2016 |
By: |
/s/ Gregory S. Patrick |
|
|
Gregory S. Patrick |
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Vice-President and Chief Financial Officer |
Exhibit 99.1
Supernus Announces Second Quarter 2016 Financial Results
· Second quarter 2016 product prescriptions totaled 123,758, a 38.9% increase over the second quarter of 2015.
· Net product sales for second quarter 2016 were $50.3 million, a 46.9% increase over the second quarter of 2015.
· Operating income for second quarter 2016 was $10.4 million compared to $3.1 million in the second quarter of 2015.
· Diluted earnings per share in the second quarter were $0.18 compared to $0.03 in the same period last year.
· Enrollment completed in SPN-812 Phase IIb trial. Enrollment for SPN-810 Phase III trials expected to continue into 2017.
Rockville, Md., August 2, 2016 - 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 2016 and associated company developments.
Commercial Update
Second quarter 2016 product prescriptions for Trokendi XR® and Oxtellar XR®, as reported by IMS, totaled 123,758, a 38.9% increase over the second quarter of 2015.
|
|
Prescriptions |
|
|
| ||
|
|
Q2 2016 |
|
Q1 2015 |
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Change % |
|
|
|
|
|
|
|
|
|
Trokendi XR |
|
93,094 |
|
65,552 |
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42.0 |
% |
Oxtellar XR |
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30,664 |
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23,534 |
|
30.3 |
% |
|
|
|
|
|
|
|
|
Total |
|
123,758 |
|
89,086 |
|
38.9 |
% |
Source: IMS
Total revenue for the second quarter of 2016 was $50.4 million, a 43.8% increase over $35.1 million in the same period last year. Total revenue for both periods consisted almost exclusively of net product sales.
|
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Net Product Sales ($mil.) |
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|
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Q2 2016 |
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Q2 2015 |
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Change % |
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|
|
|
|
|
|
| ||
Trokendi XR |
|
$ |
37.6 |
|
$ |
26.3 |
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43.3 |
% |
Oxtellar XR |
|
$ |
12.7 |
|
$ |
8.0 |
|
58.7 |
% |
|
|
|
|
|
|
|
| ||
Total |
|
$ |
50.3 |
|
$ |
34.3 |
|
46.9 |
% |
We are pleased with the growth in prescriptions and net product sales in the second quarter and through the first half of 2016. For the first six months of 2016, net product sales increased approximately 50%, as compared to the same period last year, said Jack Khattar, President and CEO of Supernus Pharmaceuticals. The solid growth in prescriptions behind our products three years post launch reinforces our belief that the combined annual peak sales for Oxtellar XR and Trokendi XR can exceed $500 million.
In June 2016 the Company submitted the revised label for Trokendi XR requesting approval to expand the label to include treatment of migraine in adults. As previously announced, this resubmission was requested by the Food and Drug Administration (FDA) to review the proposed label in a different format. The FDA has set a target date in the third quarter of 2016 to complete its review. We continue to prepare and will be ready to launch the migraine indication soon after receiving full FDA approval.
Progress of Product Pipeline
Enrollment continues for 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. The pace of enrollment is slower than anticipated due to challenges such as those experienced by caregivers in recording patient information on the new electronic diary, and lack of compliance during the screening period regarding washing out of current medications. As a consequence, we have instituted a number of measures to improve patient enrollment and retention. These include lengthening the screening period to provide increased education for site coordinators and caregivers on the electronic diary and to make it easier for caregivers and patients to comply with the trial protocol. Although the pace of recruitment has picked up recently for both Phase III trials, it is likely that enrollment will continue into 2017. The Company continues to expect to launch SPN-810 in 2019. During the third quarter of 2016, patients began enrolling into the open-label extension portion of the Phase III study.
Regarding SPN-812, currently in development for patients aged 6 to 12 years with ADHD, the Phase IIb trial is now fully recruited. The final patient visit was completed during the third quarter of 2016. Eligible patients are now entering the open label extension portion of the study. The Company continues to expect data from the SPN-812 Phase IIb trial to be available by early 2017.
With the SPN-812 Phase IIb trial fully enrolled, we have reached another important clinical milestone as we continue to advance SPN-812 into late-stage development, said Jack Khattar. Regarding SPN-810, we are encouraged by the recent progress in improving recruitment and retention, and we remain focused on the successful execution of the trials.
Mr. Khattar added, We believe the 84% rate of enrollment into the open-label extension of the Phase IIb study for SPN-812 reflects a high level of satisfaction from physicians and patients.
Operating Expenses
Research and development expenses in the second quarter of 2016 were $11.1 million, as compared to $6.9 million in the same quarter last year. This increase is primarily due to the ongoing Phase III testing of SPN-810 and Phase IIb testing of SPN-812, as well as the open-label extension studies associated with both SPN-810 and SPN-812.
Selling, general and administrative expenses in the second quarter of 2016 were $26.1 million, as compared to $23.3 million in the same quarter last year. The increase is primarily due to the efforts in preparing for the launch of the migraine indication for Trokendi XR.
Operating Income and Earnings Per Share
Operating income in the second quarter of 2016 was $10.4 million, as compared to $3.1 million in the same period last year. This improvement in operating income is primarily due to increased net product sales.
Diluted earnings per share were $0.18 in the second quarter of 2016, as compared to $0.03 in the same period last year.
Weighted-average diluted common shares outstanding were approximately 51.7 million in the second quarter of 2016, as compared to approximately 52.3 million in the same period last year.
Capital Resources
As of June 30, 2016, the Company had $128.0 million in cash, cash equivalents, marketable securities, and long term marketable securities, as compared to $117.2 million at December 31, 2015. As of June 30, 2016, approximately $6.6 million of the Companys six year, $90 million notes, bearing interest at 7.5% per annum, remain outstanding.
Financial Guidance
For full year 2016, the Company is reiterating guidance for net product sales and adjusting guidance for R&D expenses and operating income as set forth below:
· Net product sales will remain in the range of $200 million to $210 million.
· R&D expenses in the range of $50 million to $55 million, compared to the previously expected range of $55 million to $65 million.
· Operating income in the range of $32 million to $37 million, compared to the previously expected range of $28 million to $35 million.
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, August 3, 2016. 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: |
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(877) 288-1043 |
International dial-in: |
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(970) 315-0267 |
Conference ID: |
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50720151 |
Conference Call Name: |
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Supernus Pharmaceuticals 2Q 2016 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 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.
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.
Condensed Consolidated Balance Sheets
(in thousands)
|
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June 30, 2016 |
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December 31, 2015 |
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|
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(unaudited) |
|
|
| ||
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|
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|
|
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Cash, cash equivalents and marketable securities |
|
$ |
60,214 |
|
$ |
62,190 |
|
Accounts receivable, net |
|
34,281 |
|
25,908 |
| ||
Inventories, net |
|
16,373 |
|
12,587 |
| ||
Prepaid expenses and other current assets |
|
3,272 |
|
5,261 |
| ||
Total Current Assets |
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114,140 |
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105,946 |
| ||
|
|
|
|
|
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Long term marketable securities |
|
67,809 |
|
55,009 |
| ||
Property and equipment, net |
|
4,193 |
|
3,874 |
| ||
Deferred legal fees |
|
16,901 |
|
22,503 |
| ||
Intangible assets, net |
|
15,270 |
|
976 |
| ||
Other non-current assets |
|
320 |
|
318 |
| ||
Total Assets |
|
$ |
218,633 |
|
$ |
188,626 |
|
|
|
|
|
|
| ||
Accounts payable |
|
$ |
2,243 |
|
$ |
4,314 |
|
Accrued sales deductions |
|
35,019 |
|
26,794 |
| ||
Accrued expenses |
|
28,102 |
|
24,813 |
| ||
Deferred licensing revenue |
|
208 |
|
176 |
| ||
Total Current Liabilities |
|
65,572 |
|
56,097 |
| ||
|
|
|
|
|
| ||
Deferred licensing revenue, net of current portion |
|
1,606 |
|
1,390 |
| ||
Convertible notes, net of discount |
|
5,699 |
|
7,085 |
| ||
Other non-current liabilities |
|
4,322 |
|
4,325 |
| ||
Derivative liabilities |
|
412 |
|
854 |
| ||
Total Liabilities |
|
77,611 |
|
69,751 |
| ||
|
|
|
|
|
| ||
Total Stockholders Equity |
|
141,022 |
|
118,875 |
| ||
Total Liabilities & Stockholders Equity |
|
$ |
218,633 |
|
$ |
188,626 |
|
Supernus Pharmaceuticals, Inc.
Consolidated Statements of Operations
(in thousands, except share and per share data)
|
|
Three Months ended June 30, |
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Six Months ended June 30, |
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2016 |
|
2015 |
|
2016 |
|
2015 |
| ||||
|
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(unaudited) |
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(unaudited) |
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Revenue |
|
|
|
|
|
|
|
|
| ||||
Net product sales |
|
$ |
50,335 |
|
$ |
34,266 |
|
$ |
93,360 |
|
$ |
62,363 |
|
Licensing revenue |
|
86 |
|
786 |
|
135 |
|
822 |
| ||||
|
|
|
|
|
|
|
|
|
| ||||
Total revenue |
|
50,421 |
|
35,052 |
|
93,495 |
|
63,185 |
| ||||
|
|
|
|
|
|
|
|
|
| ||||
Costs and expenses |
|
|
|
|
|
|
|
|
| ||||
Cost of product sales |
|
2,751 |
|
1,762 |
|
4,786 |
|
3,380 |
| ||||
Research and development |
|
11,109 |
|
6,878 |
|
21,671 |
|
10,561 |
| ||||
Selling, general and administrative |
|
26,121 |
|
23,336 |
|
51,281 |
|
42,737 |
| ||||
|
|
|
|
|
|
|
|
|
| ||||
Total costs and expenses |
|
39,981 |
|
31,976 |
|
77,738 |
|
56,678 |
| ||||
|
|
|
|
|
|
|
|
|
| ||||
Operating income |
|
10,440 |
|
3,076 |
|
15,757 |
|
6,507 |
| ||||
Other income (expense) |
|
|
|
|
|
|
|
|
| ||||
Interest income |
|
363 |
|
137 |
|
694 |
|
250 |
| ||||
Interest expense |
|
(196 |
) |
(331 |
) |
(375 |
) |
(712 |
) | ||||
Changes in fair value of derivative liabilities |
|
123 |
|
1 |
|
224 |
|
(48 |
) | ||||
Loss on extinguishment of debt |
|
|
|
(241 |
) |
(382 |
) |
(2,375 |
) | ||||
Other income (expense) |
|
2 |
|
25 |
|
(1 |
) |
25 |
| ||||
|
|
|
|
|
|
|
|
|
| ||||
Total other income (expense) |
|
292 |
|
(409 |
) |
160 |
|
(2,860 |
) | ||||
|
|
|
|
|
|
|
|
|
| ||||
Earnings before income taxes |
|
10,732 |
|
2,667 |
|
15,917 |
|
3,647 |
| ||||
|
|
|
|
|
|
|
|
|
| ||||
Income tax expense |
|
714 |
|
662 |
|
912 |
|
724 |
| ||||
|
|
|
|
|
|
|
|
|
| ||||
Net income |
|
$ |
10,018 |
|
$ |
2,005 |
|
$ |
15,005 |
|
$ |
2,923 |
|
|
|
|
|
|
|
|
|
|
| ||||
Income per common share: |
|
|
|
|
|
|
|
|
| ||||
Basic |
|
$ |
0.20 |
|
$ |
0.04 |
|
$ |
0.30 |
|
$ |
0.06 |
|
Diluted |
|
$ |
0.18 |
|
$ |
0.03 |
|
$ |
0.28 |
|
$ |
0.06 |
|
|
|
|
|
|
|
|
|
|
| ||||
Weighted-average number of common shares: |
|
|
|
|
|
|
|
|
| ||||
Basic |
|
49,427,825 |
|
47,911,932 |
|
49,333,962 |
|
46,246,866 |
| ||||
Diluted |
|
51,745,342 |
|
52,273,549 |
|
51,484,686 |
|
47,687,992 |
|
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