Otonomy Reports First Quarter 2019 Financial Results and Provides Corporate Update
- OTO-313 Phase 1/2 trial in tinnitus initiated; results expected in first half of 2020
- OTIPRIO® co-promotion agreement completed with Glenmark Therapeutics
- OTIVIDEX™ Phase 3 trial in Ménière’s disease on track for results in first half of 2020
- OTO-413 Phase 1/2 trial in hearing loss expected to start in third quarter of 2019; results expected in second half of 2020
- Current capital funds operations into 2021
Conference call and webcast today at
"This quarterly update highlights the continued execution of our business strategy including the plan to report clinical results from three trials in 2020 -- the Phase 3 trial of OTIVIDEX in Ménière’s disease, the Phase 1/2 clinical trial of OTO-313 in tinnitus and Phase 1/2 trial of OTO-413 in hearing loss," said
Product Pipeline and Corporate Update
- Initiated Patient Enrollment for Phase 1/2 Clinical Trial of OTO-313 in Tinnitus with Results Expected in the First Half of 2020: In April,
Otonomyinitiated enrollment of the first patients in a Phase 1/2 clinical trial for OTO-313, a sustained-exposure formulation of the NMDA receptor antagonist gacyclidine, in tinnitus patients. The randomized, double-blind, placebo-controlled trial includes an initial safety cohort, which has completed enrollment, followed by an exploratory efficacy study that is initiating enrollment of approximately 50 patients with tinnitus.
- Completed OTIPRIO Co-Promotion Agreement with
Glenmark Therapeutics Inc., USA("Glenmark"): In May, Otonomyannounced the signing of a co-promotion agreement that provides Glenmark with an exclusive right to promote OTIPRIO for acute otitis externa (AOE) to ear, nose and throat (ENT) physicians in the United States. Otonomywill receive an annual co-promotion fee and reimbursement of a proportion of product support expenses, and retain a share of adjusted gross profits from the sale of OTIPRIO to Glenmark's accounts.
- Enrollment in OTIVIDEX Phase 3 Clinical Trial in Ménière’s Disease is Ongoing with Results Expected in the First Half of 2020:
Otonomyhas completed one successful Phase 3 trial and is conducting this additional pivotal trial to support a submission for U.S. registration of OTIVIDEX in Ménière’s disease. The company plans to enroll approximately 160 patients in the United Statesand Europe.
- Conducting IND-Enabling Activities to Support Initiation of a Phase 1/2 trial for OTO-413 in Hearing Loss Patients in the Third Quarter of 2019: OTO-413 is a sustained-exposure formulation of brain-derived neurotrophic factor (BDNF) in development for the repair of cochlear synaptopathy, an underlying cause of hearing loss.
Otonomyis conducting nonclinical testing and manufacturing activities to support an Investigational New Drug Application Filing (IND) with the U.S. Food and Drug Administration( FDA). The Phase 1/2 trial will enroll approximately 40 patients with speech-in-noise hearing loss. Results are expected in the second half of 2020.
Anticipated Upcoming Milestones
- In third quarter of 2019, initiate a Phase 1/2 clinical trial of OTO-413 in hearing loss patients.
- In first half of 2020, complete OTO-313 Phase 1/2 clinical trial.
- In first half of 2020, complete Phase 3 trial for OTIVIDEX in Ménière’s disease.
- In second half of 2020, complete OTO-413 Phase 1/2 clinical trial.
First Quarter Financial Highlights
- Cash Position: Cash, cash equivalents, and short-term investments totaled
$86.9 millionas of March 31, 2019, compared to $97.3 millionas of December 31, 2018.
- Operating Expenses: GAAP operating expenses were
$12.1 millionfor the first quarter of 2019, compared to $11.8 millionfor the first quarter of 2018. Non-GAAP operating expenses, which exclude stock-based compensation, were $10.6 millionfor the first quarter of 2019, compared to $9.1 millionfor the first quarter of 2018.
- Research and Development Expenses: GAAP research and development (R&D) expenses for the first quarter of 2019 were
$8.8 million, compared to $5.6 millionfor the first quarter of 2018. The increase was primarily due to expenses related to the OTIVIDEX Phase 3 clinical trial and increased costs for nonclinical and manufacturing activities to support initiation of clinical trials for OTO-313 and OTO-413.
- Selling, General and Administrative Expenses: GAAP selling, general and administrative (SG&A) expenses in the first quarter of 2019 were
$3.3 million, compared to $6.2 millionfor the first quarter of 2018. The decrease was primarily a result of reduced selling expenses due to the discontinuation of promotional support for OTIPRIO.
- Operating Expense Guidance:
Otonomyexpects that GAAP operating expenses will be in the range of $55-$60 million, and that non-GAAP operating expenses will be in the range of $45-$50 million.
Otonomyexpects that operating expenses will be lower than 2019 as multiple clinical trials are completed.
- Cash Runway:
Otonomyexpects that its current cash, cash equivalents, and short term investments will be sufficient to fund the company through completion of the OTIVIDEX Phase 3 trial, OTO-313 Phase 1/2 trial, and OTO-413 Phase 1/2 trial in 2020, and will support company operations into 2021.
Webcast and Conference Call
Non-GAAP Operating Expenses
In this press release, Otonomy’s operating expenses are provided in accordance with generally accepted accounting principles (GAAP) in
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or the future financial or operating performance of
|Condensed Balance Sheet Data|
|As of March 31,||As of December 31,|
|Cash and cash equivalents||$||16,276||$||33,633|
|Long-term debt, net||14,822||14,764|
|Leases, net of current||16,359||—|
|Total stockholders' equity||69,289||79,737|
|Condensed Statements of Operations|
|(in thousands, except share and per share data)|
|Three Months Ended|
|Product sales, net||$||192||$||301|
|Costs and operating expenses:|
|Cost of product sales||213||272|
|Research and development||8,795||5,650|
|Selling, general and administrative||3,278||6,157|
|Total costs and operating expenses||12,286||12,079|
|Loss from operations||(12,094||)||(11,778||)|
|Other income, net||110||354|
|Net loss per share, basic and diluted||$||(0.39||)||$||(0.37||)|
|Weighted-average shares used to compute net loss per share,|
|basic and diluted||30,685,412||30,568,531|
|Reconciliation of GAAP to Non-GAAP Operating Expenses|
|Three Months Ended|
|GAAP operating expenses|
|Research and development||$||8,795||$||5,650|
|Selling, general and administrative||3,278||6,157|
|Total GAAP operating expenses||12,073||11,807|
|R&D stock-based compensation expense||(659||)||(637||)|
|SG&A stock-based compensation expense||(834||)||(2,072||)|
|Total non-GAAP adjustments||(1,493||)||(2,709||)|
|Non-GAAP operating expenses||$||10,580||$||9,098|
|Reconciliation of 2019 GAAP to Non-GAAP Operating Expense Guidance|
|GAAP operating expenses||$55 - $60|
|Stock-based compensation expense||$ 10|
|Non-GAAP operating expenses||$45 - $50|
Source: Otonomy, Inc.