Supernus Announces Third Quarter 2020 Financial Results
- Q3 2020 total revenues of
$155.1 million , including net product sales of$152.1 million and royalty revenues of$3.0 million - Q3 2020 operating earnings of
$56.1 million - On track to initiate commercial launch of SPN-812 in
January 2021 , if approved by the FDA - Topline data from the SPN-812 Phase III trial in adult ADHD patients expected in Q1 2021
- Submitted SPN-830 (Apomorphine infusion pump) NDA to the FDA in
September 2020 - Increased full year 2020 net product sales guidance range of
$500 million to$525 million , and operating earnings guidance range of$145 million to$160 million
“During the first nine months of 2020, we delivered strong product sales growth, diversified our revenue base and enhanced our long term growth with two corporate transactions” said
Commercial Update
Third quarter 2020 net product sales were
| Net Product Sales ($ in millions) |
||||||||
| Q3 2020 | Q3 2019 | Change % | ||||||
| Trokendi XR | $ | 82.9 | $ | 77.3 | 7 % | |||
| Oxtellar XR | 28.3 | 22.7 | 25 % | |||||
| APOKYN | 34.5 | — | NM(1) | |||||
| XADAGO | 2.3 | — | NM(1) | |||||
| MYOBLOC | 4.1 | — | NM(1) | |||||
| Total | $ | 152.1 | $ | 100.0 | 52 % | |||
____________
(1) Fluctuation in terms of percentage change is not meaningful.
Product Pipeline Update
SPN-812 - Novel non-stimulant for the treatment of ADHD in children and adults
- The Company continues to prepare for the commercial launch of SPN-812, which is expected in
January 2021 , if approved by the FDA. The New Drug Application (NDA) Prescription Drug User Fee Act (PDUFA) target action date isNovember 8, 2020 . - The Company completed enrollment in the SPN-812 Phase III trial in adult patients with ADHD. Topline data from the trial is expected in the first quarter of 2021.
SPN-830 (Apomorphine infusion pump) - Continuous treatment of motor fluctuations (“on-off” episodes) in PD
- NDA was submitted to the
U.S. Food and Drug Administration (FDA) inSeptember 2020 for the continuous treatment of "on-off" episodes in adults with Parkinson's disease (PD) whose motor control is unsatisfactory with oral levodopa and at least one other noninvasive PD therapy. - The Company expects to launch SPN-830 in the fourth quarter of 2021, if approved by the FDA.
SPN-820 - Novel first-in-class activator of mTORC1
- Preclinical and development activities are ongoing, with the goal of initiating a Phase II clinical program in treatment-resistant depression by the end of 2021.
Operating Expenses
Research and development (R&D) expenses in the third quarter of 2020 were
Selling, general and administrative (SG&A) expenses in the third quarter of 2020 were
Amortization expense of intangible assets in the third quarter of 2020 were
Operating Earnings and Earnings Per Share
Operating earnings (GAAP) in the third quarter of 2020 were
Balance Sheet Highlights
As of
Financial Guidance
The Company is revising full year 2020 financial guidance, which consists of the following components, inclusive of the impact of acquiring the CNS portfolio of
| ($ in millions) | Current (As of |
Previous (As of |
|
| Net product sales | |||
| Research and development expense | Approximately |
Approximately |
|
| Selling, general and administrative expense | |||
| Amortization of intangible assets | $15 | ||
| Operating earnings (GAAP) |
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: | 1882244 |
| Conference Call Name: | Supernus Pharmaceuticals Third Quarter 2020 Earnings Conference Call |
Following the live call, a replay will be available on the Company's website, www.supernus.com, under “Investor Relations”.
About
See full Prescribing Information for our products here: Trokendi XR, Oxtellar XR, APOKYN, MYOBLOC, and XADAGO
All trademarks are the property of their respective owners.
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
Condensed Consolidated Balance Sheets
(in thousands, except share data)
| 2020 | 2019 | ||||||
| (unaudited) | |||||||
| Assets | |||||||
| Current assets | |||||||
| Cash and cash equivalents | $ | 204,293 | $ | 181,381 | |||
| Marketable securities | 147,657 | 165,692 | |||||
| Accounts receivable, net | 133,107 | 87,332 | |||||
| Inventories, net | 42,465 | 26,628 | |||||
| Prepaid expenses and other current assets | 24,493 | 11,611 | |||||
| Total current assets | 552,015 | 472,644 | |||||
| Long term marketable securities | 388,185 | 591,773 | |||||
| Property and equipment, net | 17,395 | 17,068 | |||||
| Operating lease assets | 21,019 | 21,279 | |||||
| Finance lease asset | 21,676 | — | |||||
| Intangible assets, net | 402,265 | 24,840 | |||||
| 89,143 | — | ||||||
| Deferred income tax assets | — | 32,063 | |||||
| Other assets | 18,324 | 615 | |||||
| Total assets | $ | 1,510,022 | $ | 1,160,282 | |||
| Liabilities and stockholders’ equity | |||||||
| Current liabilities | |||||||
| Accounts payable | $ | 11,193 | $ | 10,141 | |||
| Accrued product returns and rebates | 136,973 | 107,629 | |||||
| Accrued expenses and other current liabilities | 56,289 | 34,305 | |||||
| Contingent consideration, current portion | 82,900 | — | |||||
| Income taxes payable | — | 2,443 | |||||
| Operating lease liabilities, current portion | 3,741 | 2,825 | |||||
| Finance lease liability, current portion | 3,612 | — | |||||
| Nonrecourse liability related to sale of future royalties, current portion | 4,898 | 3,244 | |||||
| Total current liabilities | 299,606 | 160,587 | |||||
| Convertible notes, net | 357,521 | 345,170 | |||||
| Contingent consideration, long term | 33,000 | — | |||||
| Nonrecourse liability related to sale of future royalties, long term | 14,960 | 19,248 | |||||
| Operating lease liabilities, long term | 29,522 | 30,440 | |||||
| Finance lease liability, long term | 19,289 | — | |||||
| Deferred income tax liabilities | 37,941 | — | |||||
| Other liabilities | 9,304 | 9,409 | |||||
| Total liabilities | 801,143 | 564,854 | |||||
| Stockholders’ equity | |||||||
| Common stock, |
53 | 53 | |||||
| Additional paid-in capital | 403,396 | 388,410 | |||||
| Accumulated other comprehensive earnings, net of tax | 9,700 | 7,417 | |||||
| Retained earnings | 295,730 | 199,548 | |||||
| Total stockholders’ equity | 708,879 | 595,428 | |||||
| Total liabilities and stockholders’ equity | $ | 1,510,022 | $ | 1,160,282 | |||
Condensed Consolidated Statements of Earnings
(in thousands, except share and per share data)
| Three Months ended |
Nine Months ended |
||||||||||||||||||
| 2020 | 2019 | 2020 | 2019 | ||||||||||||||||
| (unaudited) | (unaudited) | ||||||||||||||||||
| Revenues | |||||||||||||||||||
| Net product sales | $ | 152,133 | $ | 100,034 | $ | 368,607 | $ | 285,491 | |||||||||||
| Royalty revenues | 3,002 | 2,106 | 8,233 | 6,818 | |||||||||||||||
| Total revenues | 155,135 | 102,140 | 376,840 | 292,309 | |||||||||||||||
| Costs and expenses | |||||||||||||||||||
| Cost of goods sold(a) | 21,388 | 4,819 | 33,926 | 12,547 | |||||||||||||||
| Research and development | 16,839 | 16,943 | 58,023 | 49,307 | |||||||||||||||
| Selling, general and administrative | 54,660 | 39,343 | 144,377 | 118,782 | |||||||||||||||
| Amortization of intangible assets | 6,108 | 1,306 | 9,814 | 3,918 | |||||||||||||||
| Total costs and expenses | 98,995 | 62,411 | 246,140 | 184,554 | |||||||||||||||
| Operating earnings | 56,140 | 39,729 | 130,700 | 107,755 | |||||||||||||||
| Other income (expense) | |||||||||||||||||||
| Interest income | 3,262 | 5,559 | 12,988 | 15,696 | |||||||||||||||
| Interest expense | (6,088 | ) | (5,662 | ) | (17,658 | ) | (16,930 | ) | |||||||||||
| Other income (expense), net | (603 | ) | (36 | ) | 2,925 | 54 | |||||||||||||
| Total other expense | (3,429 | ) | (139 | ) | (1,745 | ) | (1,180 | ) | |||||||||||
| Earnings before income taxes | 52,711 | 39,590 | 128,955 | 106,575 | |||||||||||||||
| Income tax expense | 12,714 | 10,730 | 32,773 | 26,648 | |||||||||||||||
| Net earnings | $ | 39,997 | $ | 28,860 | $ | 96,182 | $ | 79,927 | |||||||||||
| Earnings per share | |||||||||||||||||||
| Basic | $ | 0.76 | $ | 0.55 | $ | 1.83 | $ | 1.53 | |||||||||||
| Diluted | $ | 0.74 | $ | 0.54 | $ | 1.79 | $ | 1.48 | |||||||||||
| Weighted-average shares outstanding | |||||||||||||||||||
| Basic | 52,658,850 | 52,453,384 | 52,583,891 | 52,392,232 | |||||||||||||||
| Diluted | 53,762,642 | 53,805,838 | 53,663,273 | 53,898,486 | |||||||||||||||
___________________________________________
(a) Excludes amortization of acquired intangible assets
CONTACTS:
Tel: (301) 838-2591
or
INVESTOR CONTACT:
Westwicke, an
Office: (443) 213-0505
Mobile: (443) 377-4767
Email: peter.vozzo@westwicke.com
Source: Supernus Pharmaceuticals, Inc.