Supernus Provides Business Update
Third quarter 2016 product prescriptions for Trokendi XR® and Oxtellar XR®, as reported by IMS, totaled 131,408, a 30.4% increase over the third quarter of 2015.
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Net product sales for the third quarter of 2016 were
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"Supernus achieved another quarter of strong growth in product prescriptions and net sales, which reflects the strong underlying demand for our epilepsy products," said
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. As previously discussed, steps were taken this year to improve patient enrollment and retention. Preliminary results indicate that improvement has been made. The Company has partnered with an enrollment and retention agency to facilitate identifying, contacting, and prescreening appropriate patients for the clinical trials, and to assist in scheduling patients for their appointments and follow-up visits. In addition, the patient screening period for the Phase III trials has been lengthened, and increased education has been provided for site coordinators and caregivers about the trial protocol. The Company expects recruitment and retention to continue to improve as these steps become fully implemented. Enrollment is expected to continue into 2017.
Regarding SPN-812, currently in development for patients aged 6 to 12 years with ADHD, the Company announced in October positive topline results from its Phase IIb clinical trial in children with ADHD. The trial met its primary endpoint, demonstrating that SPN-812 at daily doses of 400 mg, 300 mg, and 200 mg achieved a statistically significant improvement in the symptoms of ADHD from baseline to
end of study as measured by the ADHD Rating Scale-IV. All SPN-812 doses tested in the trial were well tolerated. Supernus plans to have an end-of-Phase II meeting with the
"Given all the data generated to date, we expect SPN-812 to be a differentiated ADHD product that is a highly effective non-stimulant with a tolerable side effect profile," said
Research and development expenses in the third quarter of 2016 were
Selling, general and administrative expenses in the third quarter of 2016 were
Recent Form 8-K Filing by Company
As discussed in the Form 8-K filed by the Company on
As set forth in the Company's Form 8-K filed on
- Net product sales in the range of
$205 millionto $210 million, compared to the previously expected range of $200 millionto $210 million.
- R&D expenses in the range of
$40 millionto $44 million, compared to the previously expected range of $50 millionto $55 million.
- Taking into consideration the anticipated effects of the restatement referred to above (approximately
$4 millionto $6 million) for the full year 2016, operating income would range from $46 millionto $51 million. Excluding the anticipated effect of the restatement, operating income would range from $42 millionto $47 million, compared to the previously expected range of $32 millionto $37 million.
Cash generated from operations in the nine months ended
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 identification of additional information relevant to the ongoing accounting review; changes in the scope or focus of the accounting adjustments related to such review; the conclusions of the Audit Committee (and the timing of the conclusions) concerning matters relating to the ongoing accounting review; the timing of the review by, and the conclusions of, the Audit Committee, the Board and the Company's independent public accounting firm regarding the accounting review and the Company's financial statements; the determination of additional adjustments for the periods to be restated; the risk that the
completion and filing of the amended reports will take longer than expected; 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
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 PartnersOffice: (443) 213-0505 Mobile: (443) 377-4767 Email: firstname.lastname@example.org
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