Ovid Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results, Provides Corporate Update for 2021
March 15 2021 - 8:00AM
Ovid Therapeutics Inc. (NASDAQ: OVID) (“Ovid”), a biopharmaceutical
company committed to developing medicines that transform the lives
of people with rare neurological diseases, today reported financial
results for the fourth quarter and full year ended December 31,
2020 and provided an overview of the Company’s recent progress.
“This new agreement with Takeda strategically
positions Ovid, upon closing, to advance our next generation
neuroscience pipeline, while demonstrating the value we helped to
create for soticlestat by bringing it to the initiation of two
pivotal Phase 3 trials,” said Jeremy M. Levin, DPhil, MB, BChir,
Chairman and Chief Executive Officer of Ovid Therapeutics.
“Importantly, we believe this is a positive outcome for patients,
potentially accelerating soticlestat’s clinical development with
the potential to make this new treatment commercially available in
2024. We are excited for next steps both for this asset and for our
pipeline, as we work to file three INDs over the next three years
and in tandem pursue an active business development
initiative.”
Corporate Update
- In March 2021, Ovid announced that
it entered into an agreement with Takeda Pharmaceutical Company
Limited (“Takeda”) under which Takeda will secure global rights at
closing from Ovid to develop and commercialize the investigational
medicine soticlestat (TAK-935/OV935) for the treatment of
developmental and epileptic encephalopathies (the “transaction”),
including Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS).
On closing, Takeda will assume sole responsibility for further
worldwide development and commercialization, and Ovid will no
longer have any financial obligation to Takeda. Ovid will receive
an upfront payment of $196 million at closing and is eligible to
receive up to an additional $660 million upon achieving
development, regulatory and sales milestones. In addition, if
soticlestat achieves regulatory approval, Ovid will receive tiered
royalties beginning in the low double-digits and up to 20 percent
on net sales of soticlestat, subject to standard reductions in
certain circumstances. The new agreement is expected to close by
end of March 2021 subject to the satisfaction of customary closing
conditions, including review by the appropriate regulatory agencies
under the Hart-Scott-Rodino Act.
- Upon closing of the transaction with Takeda, all of Ovid’s
financial obligations to Takeda and the soticlestat program will be
terminated resulting in an estimated savings of at least $250
million. Ovid will not incur any additional expenditures relating
to the development and commercialization of soticlestat.
- As a result of the transaction with Takeda, Ovid expects to
reduce its cash spend significantly at closing. The Company
anticipates quarterly operating expenses, excluding non-cash
expenses, to be in the range of $8 million to $10 million,
following the closing of the transaction with Takeda.
Pipeline Update
- OV101 (gaboxadol): In December 2020, Ovid
announced that topline results from the Phase 3 NEPTUNE clinical
trial of OV101 (gaboxadol) for the treatment of Angelman syndrome
did not achieve the primary endpoint. Ovid is completing a full
analysis of the study along with the open label extension study
(ELARA), and will discuss these results with the U.S. Food and Drug
Administration (FDA).
- OV935/TAK935 (soticlestat): The two pivotal
Phase 3 studies for both DS and LGS are currently on track to
commence in the second quarter of 2021, and upon closing of the
transaction will be fully operated and funded by Takeda. If
successful, soticlestat could be commercially available as early as
2024.
- Over the past 18 months, Ovid has assembled a robust
early-stage pipeline and plans to submit three IND applications
over the next three years starting next year.
- OV329: A highly selective small molecule GABA
aminotransferase (GABA-AT) inhibitor that will be developed for the
treatment of seizures associated with tuberous sclerosis complex
and infantile spasms. IND-enabling studies are anticipated in 2021
and the Company plans to submit an IND in the first half of
2022.
- OV882: This asset
explores short hairpin RNA and its ability to interfere with UBE3A
antisense that blocks UBE3A gene expression in neurons. In
partnership with the University of Connecticut, Ovid is exploring
the use of OV882 as a noncoding RNA construct that reduces
expression of UBE3a-antisense and restores UBE3A expression via the
paternal gene. Based on encouraging discovery data to date, the
Company expects to select and name a development candidate by the
end of 2021 and enter IND-enabling studies.
- OV815: Currently in target validation, OV815
is a gene-modulation approach focused on the kinesin family of
proteins initially targeting KIF1A. This asset is part of a
collaboration with the Genomics Center at Columbia University.
Fourth Quarter and Year Ended December
31, 2020 Financial Results
- As of December 31, 2020, cash, cash
equivalents and short-term investments totaled $72.0 million,
including the receipt of a $5.0 million milestone payment from
Angelini Pharma Rare Diseases AG (“Angelini”) during the fourth
quarter, for the completion of the technology transfer and compound
delivery of OV101 in Angelman syndrome in accordance with Ovid’s
license agreement with Angelini.
- Revenue of $5.7 million was recognized during the fourth
quarter of 2020, as compared to zero for the same period in 2020.
Revenue of $12.6 million was recognized for the full year 2020, as
compared to zero for the same period in 2020. Revenue recognized
during 2020 was related to Ovid’s license agreement with
Angelini.
- Research and development expenses were $16.9 million and $63.4
million for the fourth quarter and year ended December 31, 2020,
respectively, as compared to $12.1 million and $42.2 million for
the same periods in 2019. The increase for the year ended December
31, 2020, was primarily due to an increase in development
activities related to our OV101 and OV935 development
programs.
- General and administrative expenses were $10.4 million and
$30.6 million for the fourth quarter and year ended December 31,
2020, respectively, as compared to $5.2 million and $19.3 million
for the same periods in 2019. The difference was primarily due to
increases in legal fees, compliance and pre-commercialization
expenses and professional fees.
- The Company reported a net loss of $22.0 million, or basic and
diluted net loss per share attributable to common stockholders of
$0.34, for the fourth quarter of 2020, as compared to a net loss of
$17.0 million, or basic and diluted net loss per share attributable
to common stockholders of $0.35, for the same period in 2019. The
Company reported a net loss of $81.0 million, or basic and diluted
net loss per share attributable to common stockholders of $1.39 for
the year ended December 31, 2020, compared to a net loss of $60.5
million, or basic and diluted net loss per share attributable to
common stockholders of $1.54, for the year ended December 31,
2019.
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 rare neurological disorders. We believe these disorders
represent an attractive area for drug development as the
understanding of the underlying biology has grown meaningfully over
the last few years and today represents a substantial opportunity
medically and commercially. Based on recent scientific advances in
genetics and the biological pathways of the brain, we aim to
identify, discover and acquire novel compounds for the treatment of
rare neurological disorders. We have built a deep knowledge of such
disorders, how to treat them and how to develop the clinically
meaningful endpoints required for development of a compound in
these disorders. As a result of this knowledge, Ovid has developed
a robust pipeline of first-in-class compounds and programs. We
continue to execute on our strategy to build this pipeline by
discovering, in-licensing and collaborating with leading
biopharmaceutical companies and academic institutions. These
pipeline programs include programs targeting rare epilepsies,
Angelman syndrome and Fragile X syndrome, as well as early-stage
programs into other monogenetic disorders. Ovid’s most advanced
pipeline programs include OV935 (soticlestat) in collaboration with
Takeda and OV101 a δ-selective GABAA receptor agonist.
Ovid’s emerging 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
disorder; and other non-disclosed researched targets. 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 potential benefits, clinical
and regulatory development and commercialization of soticlestat and
Ovid’s other programs and potential programs, the closing of the
Royalty, License and Termination Agreement and the potential
value, benefits, and outcome of the collaboration with Takeda. 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 uncertainties in the development and regulatory
approval processes, the fact that initial data from clinical trials
may not be indicative, and are not guarantees, of the final results
of the clinical 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, and
the ability to commercialize soticlestat. 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 Statements of
Operations(Unaudited)
|
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, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Revenue: |
|
|
|
|
|
|
|
License revenue |
$ |
5,703,187 |
|
|
$ |
- |
|
|
$ |
12,617,221 |
|
|
$ |
- |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
16,883,784 |
|
|
$ |
12,105,209 |
|
|
$ |
63,417,394 |
|
|
$ |
42,157,641 |
|
General and administrative |
|
10,410,644 |
|
|
|
5,162,720 |
|
|
|
30,630,804 |
|
|
|
19,251,826 |
|
Total
operating expenses |
|
27,294,428 |
|
|
|
17,267,929 |
|
|
|
94,048,198 |
|
|
|
61,409,467 |
|
Loss from operations |
|
(27,294,428 |
) |
|
|
(17,267,929 |
) |
|
|
(81,430,977 |
) |
|
|
(61,409,467 |
) |
Other (expense) income,
net |
|
(438,260 |
) |
|
|
298,720 |
|
|
|
395,401 |
|
|
|
948,224 |
|
Net loss |
$ |
(22,029,501 |
) |
|
$ |
(16,969,209 |
) |
|
$ |
(81,035,576 |
) |
|
$ |
(60,461,243 |
) |
Net loss attributable to
common stockholders |
$ |
(22,029,501 |
) |
|
$ |
(16,969,209 |
) |
|
$ |
(81,035,576 |
) |
|
$ |
(60,461,243 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
$ |
(0.34 |
) |
|
$ |
(0.35 |
) |
|
$ |
(1.39 |
) |
|
$ |
(1.54 |
) |
Weighted-average common shares
outstanding basic and diluted |
|
64,004,719 |
|
|
|
49,142,504 |
|
|
|
58,451,293 |
|
|
|
39,217,223 |
|
Selected Condensed Balance Sheet
Data (Unaudited)
|
December 31 |
|
December 31, |
|
2020 |
|
2019 |
|
|
|
|
Cash, cash equivalents and short-term investments |
$ |
72,033,930 |
|
$ |
76,739,113 |
Working capital1 |
|
52,780,426 |
|
|
69,279,584 |
Total Assets |
|
75,925,518 |
|
|
80,843,731 |
Total stockholder's
equity |
|
43,631,656 |
|
|
70,023,561 |
1Working capital defined as current assets less
current liabilities.
Contacts
Ovid Investors and MediaOvid
Therapeutics Inc.Investor Relations & Public Relations
irpr@ovidrx.com
Or
Ovid Investors:Argot Partners
Maeve Conneighton/Dawn
Schottlandt212-600-1902Ovid@argotpartners.com
Ovid Media Dan
Budwick1ABdan@1abmedia.com
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