Full Press Release Details
Ovid Therapeutics Reports Third Quarter 2021 Business Update,
Corporate Highlights and Financial Results
NEW YORK, November 10, 2021 Ovid Therapeutics Inc. (NASDAQ: OVID), a biopharmaceutical company committed to developing
medicines that transform the lives of people with rare neurological diseases, today provided a business update and reported corporate highlights and financial results for the quarter ended September 30, 2021.
Ovid reported its strategic intent to pursue a series of business development opportunities aimed at complementing and enhancing its pipeline of
small-molecule and next-generation medicines. The Company seeks to acquire platform technologies for the purpose of delivering precision therapeutics that act on rare genetic targets in the brain. Additionally, Ovid plans to complement its
early-stage pipeline with precision-medicine and small-molecule assets that align with its demonstrated clinical development competencies. The Company will prioritize potential medicines that can: deliver clear mechanistic targeting, leverage
defined clinical endpoints, and fill significant needs for underserved rare disease communities.
We have the capital, the expert team and the right
strategy in place to unlock value in the rapidly growing field of rare neurology, said Jeremy M. Levin, D.Phil, MB BChir, Chairman and Chief Executive Officer of Ovid Therapeutics. With the perspectives of renowned biotech leaders who
have recently joined our board and advisory team, we believe Ovid has the knowledge and access to pursue differentiated technologies and medicines for the brain. We look forward to providing updates on our business development activities.
Corporate Highlights
Third Quarter 2021 Financial Results
Non-GAAP Financial Measures
This press release presents non-GAAP adjusted operating expenses on a historical and projected basis. For the period
presented, non-GAAP adjusted operating expenses exclude from operating expenses, as calculated and presented in accordance with GAAP, non-recurring and non-cash items: OV101 clinical costs, severance expense, and stock-based compensation, respectively. Non-GAAP adjusted operating expenses is a financial measure that has not
been prepared in accordance with GAAP. Accordingly, investors should consider non-GAAP adjusted operating expenses in addition to, but not as a substitute for, operating expenses that we calculate and present
in accordance with GAAP. Among other things, our management uses non-GAAP adjusted operating expenses to establish budgets and operational goals and to manage our business. Other companies may define or use
this measure in different ways. We believe that the presentation of non-GAAP adjusted operating expenses provides investors and management with helpful supplemental information relating to operating
performance and trends. A table reconciling non-GAAP adjusted operating expenses to operating expenses for all historical periods presented is included below under the heading Reconciliation of Non-GAAP Adjusted Operating Expenses to Operating Expenses. A quantitative reconciliation of projected non-GAAP adjusted operating expenses to operating expenses is not
available without unreasonable effort primarily due to our inability to predict with reasonable certainty the amount of future stock-based compensation expense and non-recurring expenses.
About Ovid Therapeutics
Ovid Therapeutics Inc. is a New York-based biopharmaceutical company using its
BoldMedicine approach to develop medicines that transform the lives of patients with neurological disorders. Ovid seeks to couple deep CNS experience with emerging advances in
genetics and the pathways of the brain to build a leading, next-generation neuroscience pipeline. Ovid s current pipeline programs include: OV329, a small molecule GABA aminotransferase inhibitor for seizures associated with Tuberous
Sclerosis Complex and Infantile Spasms; OV882, a short hairpin RNA therapy approach for Angelman syndrome; OV815, a genetic therapy approach for KIF1A associated neurological disorders; and other research targets.
Additionally, Ovid maintains a significant financial interest in the future regulatory development and potential commercialization of soticlestat, which Takeda is responsible for advancing globally. Two Phase 3 trials for soticlestat in
Dravet syndrome and Lennox-Gastaut syndrome are actively enrolling patients. For more information on Ovid, please visit www.ovidrx.com.
Forward-Looking Statements
This press release includes
certain disclosures that contain forward-looking statements, including, without limitation, statements regarding the development and acceleration of Ovid s product candidate pipeline, Ovid s strategic approach and business
development intentions and opportunities and ability to realize the desired benefits thereof, Ovid s ability to identify acquisition targets, the potential therapeutic benefits of Ovid s current or future product candidates, the clinical
and regulatory development and potential commercialization of soticlestat, OV329 or any of Ovid s other current or future product candidates, Ovid s eligibility for potential milestone and royalty payments and Ovid s non-GAAP operating expense guidance for the fourth quarter of 2021. You can identify forward-looking statements because they contain words such as will, appears, believes and
expects. Forward-looking statements are based on Ovid s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances
that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ
materially from those in the forward-looking statements include, without limitation, uncertainties inherent in the preclinical and clinical development and regulatory approval processes, risks related to Ovid s ability to achieve its financial
objectives, the risk that Ovid may not be able to realize the intended benefits of its technology, risks related to Ovid s ability to identify acquisition targets or strategic partners, to enter into strategic transactions on favorable terms,
or to consummate and realize the benefits of any strategic transactions or acquisitions and risks to Ovid s or Takeda s abilities to meet anticipated deadlines and milestones presented by the ongoing
COVID-19 pandemic. Additional risks that could cause actual results to differ materially from those in the forward-looking statements are set forth under the caption Risk Factors in Ovid s
Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 10, 2021, and in future filings Ovid makes with the SEC. Any forward-looking statements contained in this
press release speak only as of the date hereof, and Ovid assumes no obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise
Condensed Consolidated Statements of Operations
| For The Three Months Ended September 30, 2021 | For The Three Months Ended September 30, 2020 | For The Nine Months Ended September 30, 2021 | For The Nine Months Ended September 30, 2020 | |||||||||||||
| Revenue: | ||||||||||||||||
| License and other revenue | $ | $ | 6,914,034 | $ | 12,382,779 | $ | 6,914,034 | |||||||||
| License revenue - related party | 196,000,000 | |||||||||||||||
| Total revenue | 6,914,034 | 208,382,779 | 6,914,034 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 4,917,393 | $ | 15,875,295 | $ | 28,849,969 | $ | 46,533,610 | ||||||||
| General and administrative | 6,764,341 | 7,442,401 | 28,970,053 | 20,220,160 | ||||||||||||
| Total operating expenses | 11,681,734 | 23,317,696 | 57,820,022 | 66,753,770 | ||||||||||||
| (Loss) income from operations | (11,681,734 | ) | (16,403,662 | ) | 150,562,757 | (59,839,736 | ) | |||||||||
| Other income (expenses), net | 2,657 | (21,127 | ) | (49,593 | ) | 833,661 | ||||||||||
| (Loss) income before (benefit) provision for income taxes | (11,679,077 | ) | (16,424,789 | ) | 150,513,164 | (59,006,075 | ) | |||||||||
| (Benefit) provision for income taxes | (294,829 | ) | 1,678,532 | |||||||||||||
| Net (loss) income | $ | (11,384,248 | ) | $ | (16,424,789 | ) | $ | 148,834,632 | $ | (59,006,075 | ) | |||||
| Net (loss) income per share, basic | $ | (0.17 | ) | $ | (0.28 | ) | $ | 2.15 | $ | (1.04 | ) | |||||
| Net (loss) income per share, diluted | $ | (0.17 | ) | $ | (0.28 | ) | $ | 2.14 | $ | (1.04 | ) | |||||
| Weighted-average common shares outstanding, basic | 67,929,894 | 59,406,215 | 67,282,495 | 56,586,640 | ||||||||||||
| Weighted-average common shares outstanding, diluted | 67,929,894 | 59,406,215 | 67,848,033 | 56,586,640 |
Select Condensed Balance Sheet Data
| (unaudited) | ||||||||
| September 30, 2021 | December 31, 2020 | |||||||
| Cash, cash equivalents and short-term investments | $ | 201,779,567 | $ | 72,033,930 | ||||
| Working capital 1 | 194,991,892 | 52,780,426 | ||||||
| Total assets | 207,086,188 | 75,925,518 | ||||||
| Total stockholder s equity | 197,021,761 | 43,631,656 |
Reconciliation of Non-GAAP Adjusted Operating
Expenses to Operating Expenses
| Quarter Ended September 30, 2021 | ||||
| Operating expenses | $ | 11,681,734 | ||
| Non-recurring and non-cash items included therein: | ||||
| Stock-based compensation | 1,161,911 | |||
| Wind-down of OV101 clinical costs | 1,105,283 | |||
| Severance expense | 106,746 | |||
| Non-GAAP adjusted operating expenses | $ | 9,307,794 |
Ovid Therapeutics Inc.