(State or other jurisdiction of incorporation or organization) | (Commission File Number) | (I.R.S. Employer Identification No.) | ||
(Address of Principal Executive Offices) | (Zip Code) |
Title of each class | Trading Symbol | Name of each exchange on which registered |
Number | Description | |||
99.1 | Attached |
SUPERNUS PHARMACEUTICALS, INC. | ||
DATED: August 6, 2019 | By: | /s/ Gregory S. Patrick |
Gregory S. Patrick | ||
Senior Vice-President and Chief Financial Officer |
• | Total revenue of $104.7 million, a 5.2% increase over 2018 |
• | Net product sales of $102.4 million, a 5.5% increase over 2018 |
• | Operating earnings of $42.6 million, a 19.3% increase over 2018 |
• | Submission of New Drug Application for SPN-812 on track for the second half of 2019 |
• | Revising full year 2019 net product sales guidance range to $400 million - $410 million and full year 2019 operating earnings range to $150 million - $160 million |
Prescriptions | ||||||||
Q2 2019 | Q2 2018 | Change % | ||||||
Trokendi XR | 168,682 | 158,568 | 6.4 | % | ||||
Oxtellar XR | 40,384 | 36,066 | 12.0 | % | ||||
Total | 209,066 | 194,634 | 7.4 | % |
Net Product Sales ($ in millions) | ||||||||
Q2 2019 | Q2 2018 | Change % | ||||||
Trokendi XR | 78,964 | 76,474 | 3.3 | % | ||||
Oxtellar XR | 23,394 | 20,556 | 13.8 | % | ||||
Total | 102,358 | 97,030 | 5.5 | % |
• | The Company concluded its pre-New Drug Application (NDA) clinical meeting with the U.S. Food and Drug Administration (FDA) in July 2019, and continues to expect to submit an NDA for SPN-812 in the second half of 2019. Pending FDA approval, the Company continues to expect to launch SPN-812 in the second half of 2020. |
• | The Company has advanced manufacture of SPN-812 to support the NDA submission and in preparation of commercial launch. |
• | A Phase III program in adult patients is anticipated to start in the fourth quarter of 2019. |
• | Enrollment in the Phase III P301 trial is complete, with data expected in the fourth quarter of 2019. |
• | Enrollment in the Phase III P302 trial continues, with data now expected in the first quarter of 2020. |
• | The Company continues to expect to submit an NDA for SPN-810 in the second half of 2020, and to launch SPN-810, pending FDA approval, in the second half of 2021. |
• | Enrollment in the open label extension (OLE) study continues at 90% or higher. On average, a patient in the OLE study remains on SPN-810 treatment for approximately 10.7 months, which the Company believes is an encouraging sign of the tolerability and efficacy of SPN-810. |
• | Patient dosing continues in the Phase III trial (P503) in adolescent patients. |
• | The Company remains on track to start a pivotal Phase III program for the treatment of bipolar disorder in the fourth quarter of 2019. |
• | Net product sales in the range of $400 million to $410 million, compared to the previously expected range of $435 million to $455 million. |
• | R&D expenses in the range of $70 million to $80 million. |
• | Operating earnings in the range of $150 million to $160 million, compared to the previously expected range of $160 million to $180 million. |
• | Effective tax rate of approximately 23% to 25%. |
Conference dial-in: | (877) 288-1043 |
International dial-in: | (970) 315-0267 |
Conference ID: | 1527779 |
Conference Call Name: | Supernus Pharmaceuticals Second Quarter 2019 Earnings Conference Call |
June 30, | December 31, | ||||||
2019 | 2018 | ||||||
(unaudited) | |||||||
Assets | |||||||
Current assets | |||||||
Cash and cash equivalents | $ | 87,344 | $ | 192,248 | |||
Marketable securities | 171,222 | 163,770 | |||||
Accounts receivable, net | 84,564 | 102,922 | |||||
Inventories, net | 26,024 | 25,659 | |||||
Prepaid expenses and other current assets | 21,757 | 8,888 | |||||
Total current assets | 390,911 | 493,487 | |||||
Long term marketable securities | 593,754 | 418,798 | |||||
Property and equipment, net | 4,028 | 4,095 | |||||
Intangible assets, net | 28,787 | 31,368 | |||||
Lease assets | 19,639 | — | |||||
Deferred income taxes | 25,975 | 29,683 | |||||
Other assets | 581 | 380 | |||||
Total assets | $ | 1,063,675 | $ | 977,811 | |||
Liabilities and stockholders’ equity | |||||||
Current liabilities | |||||||
Accounts payable | $ | 4,081 | $ | 3,195 | |||
Accrued product returns and rebates | 95,934 | 107,063 | |||||
Accrued expenses and other current liabilities | 38,614 | 36,535 | |||||
Income taxes payable | 2,674 | 12,377 | |||||
Non-recourse liability related to sale of future royalties, current portion | 2,668 | 2,183 | |||||
Total current liabilities | 143,971 | 161,353 | |||||
Convertible notes, net | 337,210 | 329,462 | |||||
Non-recourse liability related to sale of future royalties, long term | 21,100 | 22,575 | |||||
Lease liabilities, long term | 27,535 | — | |||||
Other liabilities | 10,955 | 11,398 | |||||
Total liabilities | 540,771 | 524,788 | |||||
Stockholders’ equity | |||||||
Common stock, $0.001 par value, 130,000,000 shares authorized 52,449,036 and 52,316,583 shares issued and outstanding as of June 30, 2019 and December 31, 2018, respectively | 52 | 52 | |||||
Additional paid-in capital | 379,369 | 369,637 | |||||
Accumulated other comprehensive earnings (loss), net of tax | 5,924 | (3,158 | ) | ||||
Retained earnings | 137,559 | 86,492 | |||||
Total stockholders’ equity | 522,904 | 453,023 | |||||
Total liabilities and stockholders’ equity | $ | 1,063,675 | $ | 977,811 |
Three Months ended June 30, | Six Months ended June 30, | ||||||||||||||
2019 | 2018 | 2019 | 2018 | ||||||||||||
(unaudited) | (unaudited) | ||||||||||||||
Revenues | |||||||||||||||
Net product sales | $ | 102,358 | $ | 97,030 | $ | 185,457 | $ | 186,150 | |||||||
Royalty revenues | 2,337 | 1,758 | 4,712 | 3,067 | |||||||||||
Licensing revenues | — | 750 | — | 750 | |||||||||||
Total revenues | 104,695 | 99,538 | 190,169 | 189,967 | |||||||||||
Costs and expenses | |||||||||||||||
Cost of product sales | 4,044 | 3,683 | 7,728 | 6,961 | |||||||||||
Research and development | 16,970 | 20,038 | 32,364 | 38,946 | |||||||||||
Selling, general and administrative | 41,083 | 40,097 | 82,051 | 76,946 | |||||||||||
Total costs and expenses | 62,097 | 63,818 | 122,143 | 122,853 | |||||||||||
Operating earnings | 42,598 | 35,720 | 68,026 | 67,114 | |||||||||||
Other income (expenses), net | 148 | (1,864 | ) | (1,041 | ) | (2,076 | ) | ||||||||
Earnings before income taxes | 42,746 | 33,856 | 66,985 | 65,038 | |||||||||||
Income tax expense | 10,019 | 3,119 | 15,918 | 7,949 | |||||||||||
Net earnings | $ | 32,727 | $ | 30,737 | $ | 51,067 | $ | 57,089 | |||||||
Earnings per share | |||||||||||||||
Basic | $ | 0.62 | $ | 0.59 | $ | 0.98 | $ | 1.10 | |||||||
Diluted | $ | 0.61 | $ | 0.57 | $ | 0.95 | $ | 1.06 | |||||||
Weighted-average shares outstanding | |||||||||||||||
Basic | 52,385,590 | 51,919,894 | 52,361,149 | 51,729,243 | |||||||||||
Diluted | 53,912,977 | 54,203,308 | 53,947,834 | 54,021,941 | |||||||||||
Cover Page |
Jul. 23, 2019 |
---|---|
Cover page. | |
Document Type | 8-K |
Document Period End Date | Aug. 06, 2019 |
Entity Registrant Name | Supernus Pharmaceuticals, Inc. |
Entity Incorporation, State or Country Code | DE |
Entity Filer Name | 001-35518 |
Entity Tax Identification Number | 20-2590184 |
Entity Address, Address Line One | 1550 East Gude Drive |
Entity Address, City or Town | Rockville |
Entity Address, State or Province | MD |
Entity Address, Postal Zip Code | 20850 |
City Area Code | 301 |
Local Phone Number | 838-2500 |
Title of 12(b) Security | Common Stock, $0.001 par value per share |
Trading Symbol | SUPN |
Security Exchange Name | NASDAQ |
Written Communications | false |
Soliciting Material | false |
Pre-commencement Tender Offer | false |
Pre-commencement Issuer Tender Offer | false |
Entity Emerging Growth Company | false |
Amendment Flag | false |
Entity Central Index Key | 0001356576 |
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