Supernus Announces First Quarter 2020 Financial Results
- First quarter total revenue of
$95.0 million , an 11% increase over 2019 - First quarter net product sales of
$92.5 million , an 11% increase over 2019 - First quarter operating earnings of
$29.0 million , a 14% increase over 2019 - On track for launch of SPN-812 at the end of 2020, pending FDA approval. PDUFA date of
November 8, 2020 for review of NDA - Acquisition of CNS portfolio of
US WorldMeds expands and strengthens neurology portfolio with established marketed products and late-stage pipeline. Expected to close in second quarter 2020 - Partnership with
Navitor Pharmaceuticals expands psychiatry portfolio with Phase II program for potential treatment of depression
Commercial Update
First quarter 2020 product prescriptions for Trokendi XR® and Oxtellar XR®, as reported by IQVIA, totaled 203,404, a 2% increase over first quarter 2019.
| Prescriptions | ||||||||
| Q1 2020 | Q1 2019 | Change % | ||||||
| Trokendi XR | 160,315 | 160,940 | — | % | ||||
| Oxtellar XR | 43,089 | 38,580 | 12 | % | ||||
| Total | 203,404 | 199,520 | 2 | % | ||||
Source: IQVIA
First quarter 2020 net product sales were
| Net Product Sales ($ in millions) |
||||||||||
| Q1 2020 | Q1 2019 | Change % | ||||||||
| Trokendi XR | $ | 68.6 | $ | 63.7 | 8 | % | ||||
| Oxtellar XR | 23.9 | 19.4 | 23 | % | ||||||
| Total | $ | 92.5 | $ | 83.1 | 11 | % | ||||
Supply of Trokendi XR and Oxtellar XR has not been impacted by COVID-19. The Company has adequate inventory on hand for both products to continue to be available to patients.
Corporate and Product Pipeline Update
SPN-812 - Novel non-stimulant for the treatment of ADHD
- The Company continues to prepare for the commercial launch of SPN-812 at the end of 2020.
- The Company remains engaged with the
U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for SPN-812 for the treatment of ADHD, which has a Prescription Drug User Fee Act (PDUFA) target action date ofNovember 8, 2020 . - The Phase III program in adult patients reached approximately 75% of the targeted enrollment before additional enrollment was put on hold in
March 2020 due to the impact of COVID-19. The Company is employing virtual efforts to ensure that currently enrolled subjects can progress to completion of treatment. This trial was ahead of schedule prior to the COVID-19 pandemic, with a potential data release in the second half of this year. Depending on when the Company can restart enrollment and complete the study, data from the trial may be pushed into 2021.
CNS portfolio of
- As announced last week, Supernus entered into a definitive Sale and Purchase Agreement to acquire the CNS portfolio of
US WorldMeds , a privately-held biopharmaceutical company. The acquisition is expected to close in the second quarter of 2020, subject to certain conditions, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. - US WorldMeds’ CNS portfolio consists of three marketed products with 2019 net sales and operating earnings of approximately
$150 million and$45 million , respectively, and a product candidate with an expected NDA submission in the second half of 2020. - The acquisition expands and strengthens the Company's neurology portfolio, diversifies its revenue and operating cash flow base and enhances long term growth.
- Total consideration consists of an upfront cash payment of
$300 million plus regulatory and commercial milestone cash payments up to$230 million . All cash consideration will be funded through existing balance sheet cash.
SPN-820 (NV-5138) – novel first-in-class activator of mTORC1
Supernus andNavitor Pharmaceuticals, Inc. , a privately-held company, announced a joint Development and Option Agreement for Navitor’s mTORC1 activator, NV-5138.- Supernus and
Navitor will jointly conduct a Phase II clinical program for NV-5138 in treatment-resistant depression. Supernus will pay up to$50 million of the costs of Phase II development, plus certain costs associated with nonclinical development and formulation. - In addition,
Navitor has granted Supernus an exclusive, worldwide (excludingGreater China ) option to license or acquire NV-5138 prior to initiation of a Phase III clinical program. In exchange for the option to license or acquire NV-5138,Navitor will receive an upfront payment of$25 million , composed of a$10 million option fee and a$15 million equity investment. The equity investment represents an approximately 13% ownership inNavitor . Total payments, exclusive of royalty payments on net sales of NV-5138 and development costs under the agreement, have the potential to reach$410 million to$475 million , which includes the upfront payment, an additional license or acquisition fee depending on whether Supernus ultimately licenses or acquires NV-5138, and subsequent clinical, regulatory and sales milestone payments. - Supernus also will have the first right of refusal for any compound with a similar mechanism of action on mTORC1 as NV-5138 in the central nervous system.
SPN-604 - Novel treatment of bipolar disorder
- The Company has reprioritized its research and development (R&D) resources following recent expansion of the product pipeline through mid to late-stage development product candidates. These product candidates include SPN-820 from the
Navitor partnership and Apomorphine Infusion Pump from theUS WorldMeds transaction. As a result, and given other factors including the estimated timing of a potential launch of SPN-604 and the required investment, the Company is terminating development of SPN-604 for the treatment of bipolar disorder.
Sales and marketing infrastructure
- The acquisition of the CNS product portfolio from
US WorldMeds includes a sales force of approximately 46 sales representatives that focuses on serving movement disorder specialists in theU.S. - The Company continues to plan on adding salesforce personnel toward the end of 2020 in anticipation of the launch of SPN-812.
“The two business development transactions that we announced over the last couple of weeks strengthen our product portfolio and late-stage pipeline, diversify our revenue base, enhance our long term growth, and strengthen our leadership position in CNS,” said
Operating Expenses
R&D expenses in the first quarter of 2020 were
SG&A expenses in the first quarter of 2020 were
Operating Earnings and Earnings Per Share
Operating earnings in the first quarter of 2020 were
Net earnings (GAAP) in the first quarter of 2020 were
Weighted-average diluted common shares outstanding were approximately 53.6 million for the first quarter of 2020, as compared to approximately 54.0 million for the prior year period.
Balance Sheet Highlights
As of
Financial Guidance
Given the uncertainty caused by the COVID-19 pandemic, the anticipated second quarter acquisition of the CNS portfolio from
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: | 9899405 |
| Conference Call Name: | Supernus Pharmaceuticals First 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
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 potential impact of COVID-19, 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 successfully incorporate and integrate acquired products and product candidates, technologies, sales force and medical organizations into its current infrastructure; 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 | $ | 225,767 | $ | 181,381 | ||||
| Marketable securities | 175,104 | 165,692 | ||||||
| Accounts receivable, net | 119,195 | 87,332 | ||||||
| Inventories, net | 24,418 | 26,628 | ||||||
| Prepaid expenses and other current assets | 12,564 | 11,611 | ||||||
| Total current assets | 557,048 | 472,644 | ||||||
| Long term marketable securities | 534,712 | 591,773 | ||||||
| Property and equipment, net | 18,011 | 17,068 | ||||||
| Intangible assets, net | 23,579 | 24,840 | ||||||
| Lease assets | 21,911 | 21,279 | ||||||
| Deferred income taxes | 34,067 | 32,063 | ||||||
| Other assets | 538 | 615 | ||||||
| Total assets | $ | 1,189,866 | $ | 1,160,282 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 3,124 | $ | 10,141 | ||||
| Accrued product returns and rebates | 119,453 | 107,629 | ||||||
| Accrued expenses and other current liabilities | 33,003 | 37,130 | ||||||
| Income taxes payable | 9,097 | 2,443 | ||||||
| Nonrecourse liability related to sale of future royalties, current portion | 3,658 | 3,244 | ||||||
| Total current liabilities | 168,335 | 160,587 | ||||||
| Convertible notes, net | 349,232 | 345,170 | ||||||
| Nonrecourse liability related to sale of future royalties, long term | 18,369 | 19,248 | ||||||
| Lease liabilities, long term | 30,804 | 30,440 | ||||||
| Other liabilities | 9,743 | 9,409 | ||||||
| Total liabilities | 576,483 | 564,854 | ||||||
| Stockholders’ equity | ||||||||
| Common stock, |
53 | 53 | ||||||
| Additional paid-in capital | 392,430 | 388,410 | ||||||
| Accumulated other comprehensive earnings (loss), net of tax | (166 | ) | 7,417 | |||||
| Retained earnings | 221,066 | 199,548 | ||||||
| Total stockholders’ equity | 613,383 | 595,428 | ||||||
| Total liabilities and stockholders’ equity | $ | 1,189,866 | $ | 1,160,282 | ||||
Condensed Consolidated Statements of Earnings
(in thousands, except share and per share data)
| Three Months ended |
|||||||||
| 2020 | 2019 | ||||||||
| (unaudited) | |||||||||
| Revenues | |||||||||
| Net product sales | $ | 92,490 | $ | 83,099 | |||||
| Royalty revenues | 2,486 | 2,375 | |||||||
| Total revenues | 94,976 | 85,474 | |||||||
| Costs and expenses | |||||||||
| Cost of goods sold | 4,152 | 3,684 | |||||||
| Research and development | 18,937 | 15,394 | |||||||
| Selling, general and administrative | 42,875 | 40,968 | |||||||
| Total costs and expenses | 65,964 | 60,046 | |||||||
| Operating earnings | 29,012 | 25,428 | |||||||
| Other income (expense) | |||||||||
| Interest expense | (5,755 | ) | (5,870 | ) | |||||
| Interest income, net | 5,777 | 4,681 | |||||||
| Total other income (expense) | 22 | (1,189 | ) | ||||||
| Earnings before income taxes | 29,034 | 24,239 | |||||||
| Income tax expense | 7,516 | 5,899 | |||||||
| Net earnings | $ | 21,518 | $ | 18,340 | |||||
| Earnings per share | |||||||||
| Basic | $ | 0.41 | $ | 0.35 | |||||
| Diluted | $ | 0.40 | $ | 0.34 | |||||
| Weighted-average shares outstanding | |||||||||
| Basic | 52,534,787 | 52,336,443 | |||||||
| Diluted | 53,581,051 | 53,985,385 | |||||||
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.