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 6, 2013
Supernus Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
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(State or other jurisdiction of Incorporation) |
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0-50440 |
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20-2590184 |
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(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 |
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(Address of principal executive offices) |
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(Zip Code) |
Registrant’s telephone number, including area code: (301) 838-2500
Not Applicable
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Item 2.02 Other Events
On August 6, 2013, Supernus issued a press release announcing that it expects to report financial results for the three and six months ending June 30, 2013 after the market closes on August 13, 2013, and will hold a conference call and webcast on that date to review the financial results as well as provide an update on other business matters. A copy of this press release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.
Item 8.01 Other Events
On August 7, 2013, Supernus issued a press release announcing that it initiated litigation against generic drug makers Actavis Inc., Watson Laboratories, Inc. – Florida, Actavis Pharma, Inc., Watson Laboratories, Inc., and Anda, Inc. (collectively “Watson”) for infringement of two patents covering its antiepileptic drug Oxtellar XR™. Both patents do not expire until April 13, 2027. The Complaint—filed in the U.S. District Court for the District of New Jersey—alleges that Watson infringed Supernus’s Oxtellar XR™ patents by submitting to the Food and Drug Administration (“FDA”) an Abbreviated New Drug Application (“ANDA”) seeking to market a generic version of Oxtellar XR™ prior to the expiration of Supernus’s patents. A copy of this press release is furnished as Exhibit 99.2 hereto and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
The following document is furnished as an Exhibit pursuant to Item 2.02 hereof:
Exhibit 99.1 – Press Release dated August 6, 2013 of the Company announcing second quarter 2013 earnings conference call and webcast.
The following document is furnished as an Exhibit pursuant to Item 8.01 hereof:
Exhibit 99.2 – Press Release dated August 7, 2013 of the Company announcing that the Company sued general drug maker Watson for infringement of Oxtellar XR™ patents.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
SUPERNUS PHARMACEUTICALS, INC.
DATED: August 8, 2013 By: /s/ Gregory S. Patrick
Gregory S. Patrick
Vice-President and Chief Financial Officer
EXHIBIT INDEX
Number Description
99.1 Press Release dated August 6, 2013 Attached
99.2 Press Release dated August 7, 2013 Attached
Exhibit 99.1
FOR IMMEDIATE RELEASE
Supernus Announces Second Quarter 2013 Earnings Conference Call and Webcast
Rockville, MD, August 6, 2013 --Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), today announced that the Company expects to report financial results for the quarter ended June 30, 2013 after the market closes on Tuesday August 13, 2013. Supernus will host a conference call at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to review the financial results, as well as provide an update on other business matters of the Company.
A live webcast will be available at www.supernus.com. The webcast will be archived on the Company's website for 30 business days following the live call.
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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 and local). The access code for the live call is 24463288.
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, or CNS, diseases. The Company has one marketed product for epilepsy, Oxtellar XR™ (extended-release oxcarbazepine), and one tentatively approved product for epilepsy, Trokendi XR™ (extended-release topiramate). The Company is also developing several product candidates in psychiatry to address large market opportunities in ADHD, including ADHD patients with impulsive aggression. These product candidates include SPN-810 for impulsive aggression in ADHD and SPN-812 for ADHD.
CONTACTS:
Jack Khattar, President and CEO
Gregory S. Patrick, Vice President and CFO
Supernus Pharmaceuticals, Inc.
Tel: (301) 838-2591
Exhibit 99.2
FOR IMMEDIATE RELEASE
Supernus Sues Watson for Infringement of Oxtellar XR™ Patents
Rockville, MD., August 7, 2013 -- Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN) announced that earlier today it sued generic drug makers Actavis Inc., Watson Laboratories, Inc. – Florida, Actavis Pharma, Inc., Watson Laboratories, Inc., and Anda, Inc. (collectively “Watson”) for infringement of two patents covering its antiepileptic drug Oxtellar XR™. Supernus’s United States Patent Nos. 7,722,898 and 7,910,131 cover once-a-day oxcarbazepine formulations and methods of treating seizures using those formulations. Both patents do not expire until April 13, 2027.
The Complaint—filed in the U.S. District Court for the District of New Jersey—alleges that Watson infringed Supernus’s Oxtellar XR™ patents by submitting to the Food and Drug Administration (“FDA”) an Abbreviated New Drug Application (“ANDA”) seeking to market a generic version of Oxtellar XR™ prior to the expiration of Supernus’s patents. Filing its Complaint within 45 days of receiving Watson’s Paragraph IV certification notice entitles Supernus to an automatic stay preventing the FDA from approving Watson’s ANDA for 30 months.
Supernus President and CEO Jack Khattar confirmed that “Supernus intends to vigorously enforce its patent rights.”
Supernus is represented by attorneys from Frommer Lawrence and Haug LLP and its corporate counsel, Saul Ewing LLP.
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, or CNS, diseases. The Company has one marketed product for epilepsy, Oxtellar XR™ (extended release oxcarbazepine), and one tentatively approved product for epilepsy, Trokendi XR™ (extended release topiramate). The Company is also developing several product candidates in psychiatry to address large market opportunities in ADHD, including ADHD patients with impulsive aggression. These product candidates include SPN-810 for impulsive aggression in ADHD and SPN-812 for ADHD.
Forward Looking Statements
This press release contains forward-looking statements regarding the Company’s ability to defend and enforce its intellectual property rights covering Oxtellar XR™. Actual results may differ materially from those in these forward-looking statements as a result of various factors, including, but not limited to, the ability of Supernus to finance potential litigation and to prevail in any such proceeding to successfully defend its intellectual property rights. For a further description of these and other risks facing the Company, please see the risk factors described in the Company’s Annual Report Form 10-K that was filed with the United States Securities and Exchange Commission on March 15, 2013 under the caption “Risk Factors” and the updates to these risk factors in the Company’s quarterly report form 10-Q filed with the commission on May 15, 2013. Forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to update or revise these statements, except as may be required by law.
CONTACT:
Jack Khattar, President and CEO
Gregory S. Patrick, Vice President and CFO
Supernus Pharmaceuticals, Inc.
Telephone: (301) 838-2591
Tel: (301) 838-2591