Supernus Announces Third Quarter 2014 Results
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The Company raises revenue guidance from approximately
$105 million to a range of$115 million to$118 million for 2014 and reaffirms cash flow break even by end of year. -
Total revenue for the quarter,
$52.5 million , includes$30.0 million in royalty monetization revenue. Net product revenue for the third quarter for Trokendi XR® and Oxtellar XR® was$22.5 million . - Third quarter product prescriptions increased to a total of 57,776, representing a 26% increase over the second quarter of 2014.
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Third quarter net income was
$27.9 million . -
Excluding the
$30 million royalty monetization payment, cash burn for the third quarter was$5 million , as compared to$8 million for the second quarter and$20 million for the first quarter. -
Significant progress on pipeline candidate SPN-810 includes receipt of fast track designation from the
FDA and an end of Phase II meeting scheduled with theFDA in December.
Business Update
Third quarter product prescriptions, as reported by Wolters-Kluwer/Symphony for Trokendi XR and Oxtellar XR, totaled 57,776, increasing by 11,963, or 26%, as compared to second quarter 2014. Trokendi XR prescriptions filled at the pharmacy for the third quarter totaled 39,524, a 28% increase over the 30,840 prescriptions for the second quarter. Oxtellar XR prescriptions for the third quarter totaled 18,252, a 22% increase over the 14,973 prescriptions for the second quarter.
"Our robust prescription growth during the quarter can be attributed to a number of factors," said
Managed care coverage continues to improve for both products. Oxtellar XR now has 180.2 million lives covered and Trokendi XR has 174.0 million lives covered. Roughly 88% of Trokendi XR and 89% of Oxtellar XR national claims are approved by payors.
"Our strong prescription growth will enable us to become cash flow break even by the end of 2014 and drive profitability in 2015," said
Revenue and Gross Margin
Total revenue for the quarter of
Net product revenue, based on shipments to wholesalers, is comprised of
The revenue from royalty agreements for the quarter of
Gross margin for the three and nine months ended
Operating Expenses
Selling, general and administrative expenses for the third quarter 2014 were
Research and development expenses during the third quarter 2014 were
Net Income and Earnings Per Share
The Company reported net income for the third quarter 2014 of
Excluding the
Weighted average diluted common shares outstanding in the third quarter 2014 were approximately 50.8 million, as compared to approximately 30.9 million during the third quarter of 2013.
As of
Capital Resources
As of
Financial Guidance
The Company is raising its 2014 revenue guidance from approximately
Progress of Product Candidates
The Company's product candidates currently in development, SPN-810 for impulsive aggression in patients who have ADHD and SPN-812 for ADHD, continue to progress on schedule. The Company plans to start studies in the second half of 2015 for both products, including a Phase III study for SPN-810 and a pivotal study for SPN-812.
The Company has scheduled an end of Phase II clinical meeting with the
On SPN-812, a novel treatment for ADHD, the Company expects to start the first pivotal trial during the second half of 2015. As previously announced the Company has selected an extended release formulation that will be the basis for the product to be used in the pivotal trials. The Company continues to progress development activities on the active drug substance, conducting further pharmacokinetic studies and preclinical activities that are required for the completion of the new drug application.
Conference Call Details
The Company will hold a conference call hosted by
| Conference dial-in: | (877) 288-1043 |
| International dial-in: | (970) 315-0267 |
| Conference ID: | 26987068 |
| Conference Call Name: |
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Following the live call, a replay will be available on the Company's website, www.supernus.com, under "Investors".
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 achieve 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
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| Condensed Consolidated Balance Sheets | ||
| (in thousands) | ||
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| (unaudited) | ||
| Cash, cash equivalents and marketable securities | $ 72,563 | $ 82,191 |
| Accounts receivable, net | 15,303 | 5,054 |
| Inventories | 11,145 | 7,152 |
| Other current assets | 3,957 | 2,764 |
| Total Current Assets | 102,968 | 97,161 |
| Property and equipment, net | 2,500 | 2,554 |
| Long term marketable securities | 15,763 | 8,756 |
| Deferred financing costs | 599 | 1,005 |
| Other long-term assets | 4,495 | 1,519 |
| Total Assets | $ 126,325 | $ 110,995 |
| Accounts payable and accrued expenses | $ 21,983 | $ 18,314 |
| Deferred product revenue, net | -- | 7,882 |
| Deferred licensing revenue | 143 | 204 |
| Total Current Liabilities | 22,126 | 26,400 |
| Deferred licensing revenue, net of current portion | 1,310 | 1,417 |
| Convertible notes, net of discount | 26,497 | 34,393 |
| Other non-current liabilities | 3,015 | 2,677 |
| Derivative liabilities | 7,258 | 12,644 |
| Total Liabilities | 60,206 | 77,531 |
| Total Stockholders' Equity | 66,119 | 33,464 |
| Total Liabilities & Stockholders Equity | $ 126,325 | $ 110,995 |
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| Consolidated Statements of Operations | ||||
| (in thousands, except share and per share data) | ||||
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Three Months ended |
Nine Months ended |
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| 2014 | 2013 | 2014 | 2013 | |
| (unaudited) | (unaudited) | |||
| Revenue | ||||
| Net product sales | $ 22,452 | $ 1,130 | $ 59,056 | $ 1,283 |
| Revenue from royalty agreement | 30,000 | -- | 30,000 | -- |
| Licensing revenue | 36 | 127 | 2,188 | 401 |
| Total revenue | 52,488 | 1,257 | 91,244 | 1,684 |
| Costs and expenses | ||||
| Cost of product sales | 1,321 | 33 | 3,476 | 37 |
| Research and development | 4,657 | 3,779 | 13,816 | 11,844 |
| Selling, general and administrative | 17,343 | 14,620 | 54,452 | 40,366 |
| Total costs and expenses | 23,321 | 18,432 | 71,744 | 52,247 |
| Operating income (loss) | 29,167 | (17,175) | 19,500 | (50,563) |
| Other income (expense) | ||||
| Interest income and other income | 80 | 102 | 267 | 292 |
| Interest expense | (1,289) | (2,870) | (3,774) | (5,742) |
| Changes in fair value of derivative liabilities | 760 | (4,153) | 2,115 | (12,692) |
| Loss on extinguishment of debt | (860) | -- | (2,592) | (1,162) |
| Total other expense | (1,309) | (6,921) | (3,984) | (19,304) |
| Net income (loss) | $ 27,858 | $ (24,096) | $ 15,516 | $ (69,867) |
| Income (loss) per common share: | ||||
| Basic | $ 0.65 | $ (0.78) | $ 0.37 | $ (2.26) |
| Diluted | $ 0.39 | $ (0.78) | $ 0.13 | $ (2.26) |
| Weighted-average number of common shares: | ||||
| Basic | 42,900,269 | 30,941,404 | 42,035,025 | 30,904,876 |
| Diluted | 50,825,633 | 30,941,404 | 50,378,186 | 30,904,876 |
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| Reconciliation of Non-GAAP Net Income (Loss) | ||||
| (in thousands) | ||||
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Three Months ended |
Nine Months ended |
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| 2014 | 2013 | 2014 | 2013 | |
| (unaudited) | (unaudited) | |||
| Net Income (Loss) - GAAP | $ 27,858 | $ (24,096) | $ 15,516 | $ (69,867) |
| Revenue from royalty agreement | (30,000) | -- | (30,000) | -- |
| Changes in fair value of derivative liabilities | (760) | 4,153 | (2,115) | 12,692 |
| Loss on extinguishment of debt | 860 | -- | 2,592 | 1,162 |
| Subtotal | (29,900) | 4,153 | (29,523) | 13,854 |
| Adjusted Net Income (Loss) - non-GAAP | $ (2,042) | $ (19,943) | $ (14,007) | $ (56,013) |
CONTACT:Jack A. Khattar , President and CEOGregory S. Patrick , Vice President and CFOSupernus Pharmaceuticals, Inc. 301-838-2591 or INVESTOR CONTACT: COCKRELL GROUP 877-889-1972 investorrelations@thecockrellgroup.com cockrellgroup.com
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