Ovid Therapeutics Reports First Quarter 2021 Financial Results and Provides Corporate Update
- Closed royalty, license and termination agreement with Takeda for soticlestat;
Ovid Therapeuticsreceived an upfront payment of $196.0 millionand is eligible to receive up to $660.0 million in additional milestone payments, plus tiered double-digit royalties, up to 20%, on sales if soticlestat is commercialized
- Ending Q1’21 cash and cash equivalents balance of
$233.1 millionand reduced cash burn supports prioritization of resources to advance robust early-stage neuroscience pipeline and explore full ecosystem of complementary external innovation
- Company is actively pursuing business development opportunities to advance its early-stage neuroscience pipeline and is planning to evaluate clinical stage assets that support its mission to bring innovative therapies to rare neurological disorders
- Appointed MIT Professor
Robert S. Langer, Sc.D. as the new Chair of its Scientific Advisory Board
“During the first quarter of 2021, Ovid strengthened its balance sheet, focused its resources, advanced its current programs, and began to explore assets that will complement this next-generation neurosciences pipeline,” said
- In late March, Ovid announced the closing of the Royalty, License and Termination Agreement under which
Takeda Pharmaceuticalssecured global rights from Ovid to develop and commercialize the investigational medicine soticlestat for the treatment of developmental and epileptic encephalopathies, including Dravet syndrome and Lennox-Gastaut syndrome. At closing, Ovid received an upfront payment of $196.0 million and is eligible to receive up to an additional $660.0 million upon achieving development, regulatory and sales milestones. In addition, Ovid is eligible to receive tiered double-digit royalties, up to 20%, on sales of soticlestat, if approved and commercialized.
March 31, 2021, the license and collaboration agreement between Angelini Pharma and the Company was terminated. As such, the Company has been released from its performance obligations and will not be entitled to any future milestone payments under the license and collaboration agreement.
- Ovid has appointed Professor
Robert S. Langer, Sc.D. as the Chair of its Scientific Advisory Boardto help guide Ovid’s strategy to tackle opportunities and scientific questions underlying disorders in the brain. Dr. Langerwill play a pivotal role as Ovid expands its thought leadership on its Scientific Advisory Boardand develops its pipeline of rare neurology programs and enabling technologies.
- The Company reiterates previous guidance of quarterly operating expenses, excluding non-cash and non-recurring expenses, of between
$8.0 millionand $10.0 millionbeginning in the second quarter of 2021.
- OV101: In April, Ovid provided an update on its OV101 program and the reallocation of resources to prioritize the development of its early-stage pipeline including OV329, OV882, and OV815. As part of the restructuring of resources, Ovid will discontinue development of OV101 (gaboxadol), a delta (δ)-selective GABAA receptor agonist, in Angelman syndrome. Furthermore, Ovid does not plan to initiate further clinical studies of OV101 in Fragile X syndrome.
- Soticlestat: Two pivotal Phase 3 studies for Dravet syndrome and Lennox-Gastaut syndrome, operated and funded by Takeda, are currently expected to commence in mid-2021. If successful, the Company estimates that soticlestat could be commercially available as early as 2024.
First Quarter 2021 Financial Results
- Revenue of
$208.4 millionwas recognized during the first quarter of 2021, as compared to zero for the same period in 2020. Revenue recognition was in relation to the receipt of the one-time upfront payment of $196.0 millionpursuant to Ovid’s agreement with Takeda, and $12.4 millionrecognized in connection with the termination of the license and collaboration agreement with Angelini Pharma.
- Research and development expenses were
$16.2 millionfor the quarter ended March 31, 2021, as compared $14.6 millionfor the same period in 2020. The increase of $1.6 millionincluded a decrease in preclinical and development expenses for the clinical studies of OV101 and an increase in Takeda collaboration expenses related to soticlestat.
- General and administrative expenses were
$15.6 millionfor the quarter ended March 31, 2021, as compared to $5.7 millionfor the same period in 2020. The increase of $9.9 millionwas primarily due to an increase in legal fees and professional fees of $8.8 million, which includes $8.2 millionof one-time fees related to the Takeda License and Termination Agreement.
- Net income was
$176.0 millionfor the quarter ended March 31, 2021resulting in basic net income per share of $2.55and diluted net income per share of $2.53. Net loss was $20.0 millionfor the quarter ended March 31, 2020, resulting in basic and diluted net loss per share of $0.37. Net income for the first quarter ended March 31, 2021was attributable to a one-time upfront payment of $196.0 millionpursuant to Ovid’s agreement with Takeda, and $12.4 millionrecognized in connection with the termination of the license and collaboration agreement with Angelini Pharma.
For more information on Ovid, please visit www.ovidrx.com.
This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, statements regarding the development of Ovid’s pipeline, the clinical and regulatory development and commercialization of soticlestat, the potential value and benefits of the Royalty, License and Termination Agreement with Takeda, Ovid’s expectations regarding its operating expenses, and use of its cash, cash equivalents and short-term investments including to develop the Company’s pipeline. 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, Ovid’s ability to discover and successfully complete preclinical and clinical development of, obtain regulatory approval for, and, if approved, successfully commercialize its current and future drug candidates in a timely manner, Takeda’s ability to successfully complete clinical development of, obtain regulatory approval for and, if approved, successfully commercialize soticlestat, uncertainties in the development and regulatory approval processes, and the fact that initial data from pre-clinical and clinical trials may not be indicative, and are not guarantees, of the final results of the trials and are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and/or more patient data become available. Additional risks that could cause actual results to differ materially from those in the forward-looking statements are set forth in Ovid’s filings with the Securities and Exchange Commission under the caption “Risk Factors.” Such risks may be amplified by the COVID-19 pandemic and its potential impact on Ovid’s business and the global economy. Ovid assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
Condensed Consolidated Statement of Operations
|For The Three Months Ended
||For The Three Months Ended
|License and other revenue||$||12,382,779||$||-|
|License revenue - related party||196,000,000||-|
|Research and development||$||16,248,909||$||14,625,367|
|General and administrative||15,576,554||5,669,019|
|Total operating expenses||31,825,463||20,294,386|
|Income (loss) from operations||176,557,316||(20,294,386||)|
|Other (expenses) income, net||(49,732||)||264,296|
|Income (loss) before provision for income taxes||176,507,584||(20,030,090||)|
|Provision for income taxes||500,277||-|
|Net income (loss)||$||176,007,307||$||(20,030,090||)|
|Net income (loss) per share, basic||$||2.55||$||(0.37||)|
|Net income (loss) per share, diluted||$||2.53||$||(0.37||)|
|Weighted-average common shares outstanding, basic||66,088,592||54,715,610|
|Weighted-average common shares outstanding, diluted||66,578,377||54,715,610|
Selected Condensed Balance Sheet
|Cash, cash equivalents and short-term investments||$||233,051,160||$||72,033,930|
|Total stockholder's equity||221,109,940||43,631,656|
|1Working capital defined as current assets less current liabilities|
Investor Relations & Public Relations
Source: Ovid Therapeutics Inc.