Supernus Announces Record Full Year 2017 Financial Results, Exceeding Operating Earnings Guidance
- Fourth quarter 2017 total revenue of
$88.4 million , a 42% increase over 2016, and fourth quarter 2017 net product sales of$86.3 million , a 41% increase over 2016. - Fourth quarter 2017 operating earnings of
$34.3 million , a 110% increase over 2016. - Full year 2017 total revenue of
$302.2 million , a 41% increase over 2016. Full year 2017 net product sales of$294.1 million , a 40% increase over 2016, were at the top end of Company guidance. - Full year 2017 operating earnings of
$99.5 million , an 84% increase over 2016, exceeded Company guidance of$85 million to$90 million . - Full year 2017 GAAP diluted earnings per share of
$1.08 , compared to$1.76 in 2016. Adjusting for one-time impacts in 2017 and 2016, non-GAAP diluted earnings per share in 2017 of$1.26 , compared to$0.68 in 2016, increased by 85%.
(1) See reconciliation of GAAP diluted EPS to non-GAAP diluted EPS in table at the end of this release.
Commercial Update
Fourth quarter 2017 product prescriptions for Trokendi XR® and Oxtellar XR®, as reported by IQVIA (formerly IMS), totaled 198,715, a 47.3% increase over the fourth quarter of 2016. Full year 2017 product prescriptions for Trokendi XR® and Oxtellar XR®, as reported by IQVIA, totaled 672,709, a 33.8% increase over full year 2016.
Prescriptions | ||||||
Q4 2017 | Q4 2016 | Change % | FY 2017 | FY 2016 | Change % | |
Trokendi XR | 162,208 | 101,869 | 59.2% | 533,541 | 378,584 | 40.9% |
Oxtellar XR | 36,507 | 33,081 | 10.4% | 139,168 | 124,270 | 12.0% |
Total | 198,715 | 134,950 | 47.3% | 672,709 | 502,854 | 33.8% |
Source: IQVIA | ||||||
Net product sales for the fourth quarter of 2017 were
Net Product Sales ($millions) | ||||||||||
Q4 2017 | Q4 2016 | Change % | FY 2017 | FY 2016 | Change % | |||||
Trokendi XR | 48.0% | 43.0% | ||||||||
Oxtellar XR | 19.4% | 30.8% | ||||||||
Total | 41.2% | 40.0% | ||||||||
"The strong financial results achieved in the fourth quarter and full year of 2017 reflect the successful launch of Trokendi XR in migraine, as well as continued double digit growth by Oxtellar XR," said
Progress of Product Pipeline
Overall enrollment in the four Phase III trials for SPN-812, a novel non-stimulant for the treatment of ADHD, is approximately 38% complete. The program consists of four three-arm, placebo-controlled trials: two pediatric trials and two adolescent trials. The Company expects to continue enrollment through mid-2018 and to have data from this Phase III program available by the first quarter of 2019.
Enrollment continues in both Phase III trials (P301 and P302) for SPN-810, currently in development for Impulsive Aggression in pediatric patients who have ADHD. Enrollment in P301 and P302 is approximately 80% and 65% complete, respectively, and is expected to continue through mid-2018, with data from the trials anticipated by the first quarter of 2019. In addition, a Phase III trial for SPN-810 treating Impulsive Aggression in adolescents who have ADHD is anticipated to start mid-2018. This adolescent trial is not expected to materially affect the overall timing of the regulatory submission process for SPN-810.
Regarding Oxtellar XR, the investigator-sponsored trial in bipolar disorder is expected to complete enrollment by year end 2018.
"Our strategy in 2018 is to advance SPN-810 and SPN-812 through Phase III clinical development, moving us closer to our goal of delivering from our current pipeline two novel products, both addressing billion-dollar market opportunities," said
Operating Expenses
Research and development expenses in the fourth quarter of 2017
were
Selling, general and administrative expenses in the fourth quarter of 2017 were
Operating Earnings and Earnings Per Share
Operating earnings in the fourth quarter of 2017 were
Net earnings (GAAP) in the fourth quarter of 2017 was
Full year 2017 net earnings would have increased by 90.3% to
Diluted earnings per share (GAAP) were
Weighted-average diluted common shares outstanding were approximately 53.5 million and 53.3 million in the fourth quarter and full year of 2017, respectively, as compared to approximately 52.0 million and 51.7 million in each of the respective prior year periods.
As of
Financial Guidance
For full year 2018, the Company estimates net product sales, research and development expenses, operating earnings, and an effective tax rate as set forth below:
- Net product sales in the range of
$375 million to$400 million . - Research and development expenses of approximately
$80 million . - Operating earnings in the range of
$125 million to$135 million , including approximately$7 million of licensing and non-cash royalty revenue. - Effective tax rate of approximately 23% to 25%.
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 ID: | 9385269 | ||||||
Conference Call Name: | Supernus Pharmaceuticals Fourth Quarter and Full Year 2017 Earnings Conference Call | ||||||
Following the live call, a replay will be available on the Company's website, www.supernus.com, under "Investor Relations".
About
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 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
Non-GAAP Financial Results
Financial results for 2017 and 2016 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with GAAP and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain one-time adjustments that are unusual or unpredictable. Management believes non-GAAP financial measures provide useful information to investors regarding the Company's results of operations and assist management, analysts, and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. For a reconciliation of these non-GAAP financial measures to the most comparable GAAP measures, please refer to the table at the end of this press release.
Consolidated Balance Sheets | |||||||||
(in thousands, except share amounts) | |||||||||
2017 | 2016 | ||||||||
(unaudited) | |||||||||
Assets | |||||||||
Current assets | |||||||||
Cash and cash equivalents | $ | 100,304 | $ | 66,398 | |||||
Marketable securities | 39,736 | 23,723 | |||||||
Accounts receivable, net | 65,586 | 41,527 | |||||||
Inventories, net | 16,304 | 16,801 | |||||||
Prepaid expenses and other current assets | 6,521 | 2,955 | |||||||
Total current assets | 228,451 | 151,404 | |||||||
Long term marketable securities | 133,638 | 75,410 | |||||||
Property and equipment, net | 5,124 | 4,344 | |||||||
Intangible assets, net | 36,019 | 36,350 | |||||||
Other non-current assets | 389 | 331 | |||||||
Deferred income taxes | 20,843 | 41,729 | |||||||
Total assets | $ | 424,464 | $ | 309,568 | |||||
Liabilities and stockholders' equity | |||||||||
Current liabilities | |||||||||
Accounts payable | $ | 6,844 | $ | 8,055 | |||||
Accrued sales deductions | 68,343 | 41,943 | |||||||
Accrued expenses | 27,305 | 27,427 | |||||||
Income taxes payable | 15,938 | 7 | |||||||
Non-recourse liability related to sale of future royalties, current portion | 4,283 | 3,101 | |||||||
Deferred licensing revenue | 287 | 209 | |||||||
Total current liabilities | 123,000 | 80,742 | |||||||
Deferred licensing revenue, net of current portion | 1,149 | 1,501 | |||||||
Convertible notes, net | - | 4,165 | |||||||
Non-recourse liability related to sale of future royalties, long term | 22,258 | 27,289 | |||||||
Other non-current liabilities | 10,577 | 4,002 | |||||||
Derivative liabilities | - | 114 | |||||||
Total liabilities | 156,984 | 117,813 | |||||||
Stockholders' equity | |||||||||
Common stock, | 51 | 50 | |||||||
Additional paid-in capital | 294,999 | 276,127 | |||||||
Accumulated other comprehensive loss, net of tax | (747 | ) | (134 | ) | |||||
Accumulated deficit | (26,823 | ) | (84,288 | ) | |||||
Total stockholders' equity | 267,480 | 191,755 | |||||||
Total liabilities and stockholders' equity | $ | 424,464 | $ | 309,568 | |||||
Consolidated Statements of Earnings | |||||||||||||||
(in thousands, except share and per share data) | |||||||||||||||
Three Months ended | Year ended | ||||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||||
(unaudited) | (unaudited) | ||||||||||||||
Revenue | |||||||||||||||
Net product sales | $ | 86,334 | $ | 61,100 | $ | 294,097 | $ | 210,078 | |||||||
Royalty revenue | 2,029 | 1,222 | 6,367 | 4,686 | |||||||||||
Licensing revenue | 72 | 52 | 1,774 | 239 | |||||||||||
Total revenue | 88,435 | 62,374 | 302,238 | 215,003 | |||||||||||
Costs and expenses | |||||||||||||||
Cost of product sales | 4,154 | 3,771 | 15,215 | 11,986 | |||||||||||
Research and development | 16,173 | 13,252 | 49,577 | 42,791 | |||||||||||
Selling, general and administrative | 33,764 | 29,055 | 137,905 | 106,010 | |||||||||||
Total costs and expenses | 54,091 | 46,078 | 202,697 | 160,787 | |||||||||||
Operating earnings | 34,344 | 16,296 | 99,541 | 54,216 | |||||||||||
Other income (expense) | |||||||||||||||
Interest income | 877 | 396 | 2,864 | 1,467 | |||||||||||
Interest expense | — | 33 | (134 | ) | (543 | ) | |||||||||
Interest expense-nonrecourse liability related to sale of future royalties | (160 | ) | (984 | ) | (1,434 | ) | (4,548 | ) | |||||||
Changes in fair value of derivative liabilities | — | 100 | 76 | 448 | |||||||||||
Loss on extinguishment of debt | — | (289 | ) | (295 | ) | (671 | ) | ||||||||
Total other income (expense) | 717 | (744 | ) | 1,077 | (3,847 | ) | |||||||||
Earnings before income taxes | 35,061 | 15,552 | 100,618 | 50,369 | |||||||||||
Income tax expense (benefit) | 21,403 | 1,232 | 43,334 | (40,852 | ) | ||||||||||
Net earnings | $ | 13,658 | $ | 14,320 | $ | 57,284 | $ | 91,221 | |||||||
Earnings per share | |||||||||||||||
Basic | $ | 0.27 | $ | 0.29 | $ | 1.13 | $ | 1.84 | |||||||
Diluted | $ | 0.26 | $ | 0.26 | $ | 1.08 | $ | 1.76 | |||||||
Weighted-average number of common shares outstanding | |||||||||||||||
Basic | 51,268,465 | 49,702,207 | 50,756,603 | 49,472,434 | |||||||||||
Diluted | 53,534,217 | 52,020,596 | 53,301,150 | 51,708,983 | |||||||||||
Reconciliation of | |||||||||
For the Period Ended | |||||||||
(in thousands, except share and per share data) | |||||||||
Reconciliation of | |||||||||
Year Ended | |||||||||
2017 | 2016 | ||||||||
(unaudited) | |||||||||
As reported Net Earnings (GAAP) | $ | 57,284 | $ | 91,221 | |||||
Specific one-time adjustments: | |||||||||
Release of valuation allowance on deferred tax assets (1) | - | (56,019 | ) | ||||||
Impact of the Tax Cuts and Jobs Act (1) | 9,694 | - | |||||||
Adjusted Net Earnings (Non-GAAP) | $ | 66,978 | $ | 35,202 | |||||
Reconciliation of | |||||||||
Year Ended | |||||||||
2017 | 2016 | ||||||||
(unaudited) | |||||||||
As reported Diluted EPS (GAAP) | $ | 1.08 | $ | 1.76 | |||||
Adjusted for specific one-time adjustments: | |||||||||
Release of valuation allowance on deferred tax assets (1) | - | (1.08 | ) | ||||||
Impact of the Tax Cuts and Jobs Act (1) | 0.18 | - | |||||||
As adjusted Diluted EPS (Non-GAAP) | $ | 1.26 | $ | 0.68 | |||||
Weighted Average Diluted Shares | 53,301,150 | 51,708,983 | |||||||
(1 | ) | Non-GAAP adjustments relate primarily to the income tax adjustment on deferred tax assets and are calculated using the statutory income tax rate in effect at the time the deferred tax assets are expected to reverse. In 2016, the Company eliminated the valuation allowance on deferred tax assets. The Company has no recorded valuation allowance on its deferred tax assets in 2017. In 2017, the Company wrote down its net deferred tax assets to reflect the estimated impact of the decrease in federal statutory rates, as specified in the new tax legislation on the value of the Company's net deferred tax assets. The newly enacted Tax Cuts and Jobs Act lowered the | |||||||
CONTACTS:
Tel: (301) 838-2591
or
INVESTOR CONTACT:
Office: (443) 213-0505
Mobile: (443) 377-4767
Email: peter.vozzo@westwicke.com
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