Supernus Announces Third Quarter 2019 Financial Results and Topline Data from Phase III Study of SPN-810 for Treatment of Impulsive Aggression (IA) in ADHD Patients
- Total revenue of
$102.1 million, compared to $103.0 millionin third quarter 2018
- Net product sales of
$100.0 million, compared to $100.2 millionin third quarter 2018
- Operating earnings of
$39.7 million, compared to $37.5 millionin third quarter 2018
- NDA submission for SPN-812 expected in
- Phase III P301 trial of SPN-810 for the treatment of IA in ADHD patients 6 to 11 years old did not meet its primary endpoint
Third quarter 2019 product prescriptions for Trokendi XR® and Oxtellar XR®, as reported by
|Q3 2019||Q3 2018||Change %|
Net product sales for the third quarter of 2019 were
|Net Product Sales
($ in thousands)
|Q3 2019||Q3 2018||Change %|
“For the quarter and year to date periods, the beneficial impact of volume growth and price increases has been offset by continued pressure on gross-to-net sales deductions,” said
SPN-812 - Novel non-stimulant for the treatment of ADHD
- The Company expects to submit a New Drug Application (NDA) to the
U.S. Food and Drug Administration( FDA) for SPN-812 for the treatment of ADHD in November 2019.
- A Phase III program in adult patients was initiated during the third quarter of 2019.
SPN-810 - Novel treatment of Impulsive Aggression (IA) in patients with ADHD
- Phase III P301 trial in patients 6 to 11 years old did not meet its primary endpoint. The study was a randomized, double-blind, placebo controlled, multicenter, parallel group clinical trial in patients diagnosed with ADHD. Patients receiving SPN-810 36mg showed a median percent reduction of 58.6% in the average weekly frequency of impulsive aggression episodes from baseline that was not statistically significant (p= 0.092) compared to placebo. These results are based on the combined analysis of data from stages 1 and 2 in the study. In stage 1 (interim analysis stage), the median percent reduction was 60%, which was statistically significant (p= 0.029) compared to placebo. However, in stage 2 of the study, post the interim analysis, the increase in variability in the 36mg treatment arm seems to have adversely impacted the results in the combined analysis.
|Percent Change from Baseline (CFB) in the Frequency of IA Behaviors
Treatment Period - Primary Analysis (ITT Population)
|Stage 1 - % CFB||Placebo||SPN-810
|Mean (SD)||-42.9 (35.9)||-45.8 (33.5)||-56.6 (34.1)|
|Stage 2 - % CFB|
|Mean (SD)||-43.8 (36.3)||-44.5 (34.6)||-44.0 (43.5)|
|Stages 1 & 2 Combined - % CFB|
|Mean (SD)||-43.4 (36.0)||-45.5 (33.5)||-48.2 (40.9)|
- The median percent reduction in frequency of IA behavior in this Phase III study is consistent with the range of percent improvement in the retrospective modified aggression scale (58% - 62%) we saw in the two positive treatment arms in the Phase IIb study. The Company will continue its analysis of the results to better understand the reasons behind the increased variability in the 36mg treatment arm in the P301 study.
- Overall, the trial exhibited favorable tolerability and safety profiles with low incidence of adverse events (AEs) across all doses. AEs were mild leading to low discontinuation rates of 0%, 7% and 5% for the 18mg, 36mg and combined treatment arms, respectively.
|Adverse Event (AE)
|Fatigue||1 (0.8)||2 (3.1)||10 (7.3)||12 (5.9)|
|Headache||2 (1.6)||2 (3.1)||7 (5.1)||9 (4.5)|
|Increased Appetite||6 (4.8)||0||9 (6.6)||9 (4.5)|
|Blood Prolactin Increased||1 (0.8)||4 (6.2)||2 (1.5)||6 (3.0)|
|Upper Respiratory Tract Infection||8 (6.3)||2 (3.1)||2 (1.5)||4 (2.0)|
|Discontinuation Rate due to AE’s||4 (3.1)||0 (0)||10 (7.2)||10 (4.9)|
- Enrollment in the Phase III P302 trial in patients 6 to 11 years old is at 98% of the target. The Company will cease enrollment in the P302 trial and analyze the data, which are expected to be available by the end of 2019. In the meantime, enrollment in the P503 Phase III trial (adolescents) is on hold until data from the P302 study are available and a final decision is reached regarding the SPN-810 program in IA. Mr. Khattar added, “We are obviously disappointed with the efficacy results from our Phase III P301 trial with SPN-810. I thank all our employees for working diligently to complete the studies and believing in what we do for our patients. I also thank all our patients, their families, and our investigators for participating in our studies.”
SPN-604 - Novel treatment of bipolar disorder
- The Company initiated a pivotal Phase III monotherapy trial for the treatment of bipolar disorder in the fourth quarter of 2019.
Research and development (R&D) expenses in the third quarter of 2019 were
Selling, general and administrative (SG&A) expenses in the third quarter of 2019 were
Operating Earnings and Earnings Per Share
Operating earnings in the third quarter of 2019 were
Net earnings (GAAP) in the third quarter of 2019 were
Weighted-average diluted common shares outstanding were approximately 53.8 million in the third quarter of 2019, as compared to approximately 54.2 million in the prior year period.
Balance Sheet Highlights
As of September 30, 2019, the Company had
The Company is revising its full year 2019 guidance for net product sales, R&D expenses and operating earnings, and reaffirming expectations for the effective tax rate as set forth below:
- Net product sales in the range of
$390 million to $395 million, compared to the previously expected range of $400 million to $410 million.
- R&D expenses of approximately
$70 million, compared to the previously expected range of $70 million to $80 million.
- Operating earnings in the range of
$150 million to $155 million, compared to the previously expected range of $150 million to $160 million.
- Effective tax rate of approximately 23% to 25%.
Looking forward to 2020, the Company expects that the combined impact of product unit volume growth and price increases will be offset by continued pressure on gross-to-net sales deductions. In addition, the Company expects to launch SPN-812 in the second half of 2020. As such, the Company expects SG&A expenses to exceed
Conference Call Details
The Company will hold a conference call hosted by
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 Call Name:||Supernus Pharmaceuticals Third Quarter 2019 Earnings Conference Call|
Following the live call, a replay will be available on the Company's website, www.supernus.com, under “Investor Relations”.
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 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 filings with the
Condensed Consolidated Balance Sheets
(in thousands, except share data)
|September 30,||December 31,|
|Cash and cash equivalents||$||116,889||$||192,248|
|Accounts receivable, net||86,699||102,922|
|Prepaid expenses and other current assets||18,182||8,888|
|Total current assets||427,082||493,487|
|Long term marketable securities||596,442||418,798|
|Property and equipment, net||9,977||4,095|
|Intangible assets, net||26,101||31,368|
|Deferred income taxes||27,953||29,683|
|Liabilities and stockholders’ equity|
|Accrued product returns and rebates||98,050||107,063|
|Accrued expenses and other current liabilities||40,800||36,535|
|Income taxes payable||4,818||12,377|
|Nonrecourse liability related to sale of future royalties, current portion||2,959||2,183|
|Total current liabilities||149,717||161,353|
|Convertible notes, net||341,163||329,462|
|Nonrecourse liability related to sale of future royalties, long term||20,305||22,575|
|Lease liabilities, long term||27,256||—|
|Common stock, $0.001 par value; 130,000,000 shares authorized; 52,462,936 and 52,316,583 shares issued and outstanding as of September 30, 2019 and December 31, 2018, respectively||52||52|
|Additional paid-in capital||383,525||369,637|
|Accumulated other comprehensive earnings (loss), net of tax||7,261||(3,158||)|
|Total stockholders’ equity||557,257||453,023|
|Total liabilities and stockholders’ equity||$||1,106,909||$||977,811|
Condensed Consolidated Statements of Earnings
(in thousands, except share and per share data)
|Three Months ended
|Nine Months ended
|Net product sales||$||100,034||$||100,227||$||285,491||$||286,377|
|Costs and expenses|
|Cost of goods sold||4,819||4,207||12,547||11,168|
|Research and development||16,943||20,422||49,307||59,368|
|Selling, general and administrative||40,649||40,892||122,700||117,838|
|Total costs and expenses||62,411||65,521||184,554||188,374|
|Other income (expenses), net||(139||)||(1,104||)||(1,180||)||(3,180||)|
|Earnings before income taxes||39,590||36,371||106,575||101,409|
|Income tax expense||10,730||8,360||26,648||16,309|
|Earnings per share|
|Weighted-average shares outstanding|
Tel: (301) 838-2591
Office: (443) 213-0505
Mobile: (443) 377-4767
Source: Supernus Pharmaceuticals, Inc.