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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02. Results of Operations and Financial Condition.
On March 15, 2022, Ovid Therapeutics Inc. (the “Company”) issued a press release announcing Business Update, Fourth Quarter and Full Year 2021 Financial Results. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information provided in this Item 2.02, including Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibit
Exhibit No. |
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Description |
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99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
OVID THERAPEUTICS INC. |
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By: |
/s/ Thomas M. Perone |
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Thomas M. Perone |
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General Counsel & Corporate Secretary |
Dated: March 15, 2022
Exhibit 99.1
Ovid Therapeutics Reports Business Update, Fourth Quarter and Full Year 2021 Financial Results
NEW YORK, March 15, 2022 -- Ovid Therapeutics Inc. (NASDAQ: OVID), a biopharmaceutical company committed to developing medicines that transform the lives of people with epilepsies and seizure-related disorders, today provided a business update and reported financial results for the fourth quarter and full year ended December 31, 2021.
"Ovid is disciplined in our focus to become a leader in epilepsy therapies. We are advancing a pipeline with novel mechanisms of action, which we hope will become medicines for the nearly 20-40% of epilepsy patients who continue to experience seizures on current therapies,” said Jeremy M. Levin, D. Phil, MB BChir, Chairman and Chief Executive Officer of Ovid. “We are on track to initiate a clinical trial this year for OV329, a novel GABA aminotransferase inhibitor for tuberous sclerosis seizures, and we look forward to Takeda presenting pivotal Phase 3 results on soticlestat in Dravet and Lennox-Gastaut syndromes in 2023.”
Dr. Levin added, “We believe the organizational changes announced today ensure that Ovid has a focused team and substantial cash runway to execute on our strategy. We are grateful to our departing colleagues who contributed their expertise to our company, programs and patients. We wish them great success in the future.”
Business Update and Strategy
Pipeline Updates & Anticipated Milestones
Fourth Quarter and Year-End December 31, 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, the following non-recurring and non-cash items: license acquisition costs; wind down of OV101 clinical costs; stock-based compensation. 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 epilepsies and seizure-related disorders. Ovid’s current pipeline programs include: OV329, a small molecule GABA aminotransferase inhibitor for seizures associated with Tuberous Sclerosis Complex and Infantile Spasms; OV350, a direct KCC2 activator for potential treatment of epilepsies; 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 active. 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 of Ovid’s product candidate pipeline and achievement of expected near- and long-term milestones, Ovid's strategic approach and business development intentions and opportunities and ability to execute thereon and realize the desired benefits thereof, the potential therapeutic benefits of Ovid's current or future product candidates, the clinical and regulatory development and potential commercialization of soticlestat, OV329, OV350, or any of Ovid’s other current or future product candidates, Ovid’s eligibility for potential milestone and royalty payments, Ovid’s expectations regarding cost savings related to and the timing of completion of its organizational restructuring, and Ovid’s expectations regarding its cash runway. 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 or its business strategy, 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 any of its collaboration partners’ 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 required by law.
Condensed Consolidated Statements of Operations
Unaudited
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For the Three Months Ended December 31, |
For the Three Months Ended December 31, |
For the Year Ended December 31, |
For the Year Ended December 31, |
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2021 |
2020 |
2021 |
2020 |
Revenue: |
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License and other revenue |
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$ - |
$ 5,703,187 |
$ 12,382,779 |
$ 12,617,221 |
License revenue - related party |
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- |
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196,000,000 |
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Total revenue |
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5,703,187 |
208,382,779 |
12,617,221 |
Operating expenses: |
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Research and development |
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$ 18,089,614 |
$ 16,883,784 |
$ 46,939,583 |
$ 63,417,394 |
General and administrative |
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8,264,050 |
10,410,644 |
37,234,104 |
30,630,804 |
Total operating expenses |
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26,353,664 |
27,294,428 |
84,173,687 |
94,048,198 |
Income (loss) from operations |
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(26,353,664) |
(21,591,241) |
124,209,092 |
(81,430,977) |
Other (expense) income, net |
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3,901 |
(438,260) |
(45,690) |
395,401 |
Income (loss) before provision (benefit) for income taxes |
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(26,349,763) |
(22,029,501) |
124,163,402 |
(81,035,576) |
Provision (benefit) for income taxes |
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(349,714) |
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1,328,818 |
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Net income (loss) |
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$ (26,000,049) |
$ (22,029,501) |
$ 122,834,584 |
$ (81,035,576) |
Net income (loss) per share, basic |
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$ (0.38) |
$ (0.34) |
$ 1.78 |
$ (1.39) |
Net income (loss) per share, diluted |
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$ (0.38) |
$ (0.34) |
$ 1.76 |
$ (1.39) |
Weighted-average common shares outstanding basic |
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68,159,651 |
64,004,719 |
67,479,403 |
58,451,293 |
Weighted-average common shares outstanding diluted |
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68,159,651 |
64,004,719 |
68,067,992 |
58,451,293 |
Select Condensed Balance Sheet Data
Unaudited
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December 31, |
December 31, |
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2021 |
2020 |
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Cash and cash equivalents |
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$ 187,797,532 |
$ 72,033,930 |
Working capital1 |
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175,680,808 |
52,780,426 |
Total assets |
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194,544,757 |
75,925,518 |
Total stockholder's equity |
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179,746,436 |
43,631,656 |
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1Working capital defined as current assets less current liabilities |
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Reconciliation of Non-GAAP Adjusted Operating Expenses to Operating Expenses
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Three Months Ended December 31, |
Year Ended |
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2021 |
2021 |
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Operating expenses |
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$ 26,353,664 |
$ 84,173,687 |
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Non-recurring and non-cash items included therein: |
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License Acquisition Costs expensed to R&D |
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$ 12,300,000 |
$ 12,300,000 |
Stock-based compensation |
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1,315,198 |
5,054,457 |
Legal and professional fees related to License Acquisition |
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$ 745,503 |
$ 745,503 |
Wind-down of OV101 clinical costs |
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345,454 |
6,855,021 |
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Non-GAAP adjusted operating expenses |
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$ 11,647,509 |
$ 59,218,706 |
Contacts
Investors and Media:
Ovid Therapeutics Inc.
Meg Alexander
917-943-6681
OR
Investors:
Argot Partners
Dawn Schottlandt
212-600-1902