Otonomy Announces Third Quarter Earnings and the Selection of OTO-413 Presentation at SFN
Otonomy ($OTIC), a company working to develop a pipeline of products addressing important unmet medical needs including Ménière’s disease, hearing loss, and tinnitus, released their earnings and financial highlights for the third quarter of 2018.
During the quarter, the company reported a loss of $12.5 million with revenue of $113,000, which is a loss of 41 cents per share. Analysts expected ~$246,000 in revenue for the quarter.
Additional Financial Highlights From the Quarter
- Cash Position: Cash, cash equivalents, and short-term investments totaled $92.6 million as of September 30, 2018, compared to $120.0 million as of December 31, 2017.
- Operating Expenses: GAAP operating expenses were $13.1 million for the third quarter of 2018, compared to $21.6 million for the third quarter of 2017. Non-GAAP operating expenses, which exclude stock-based compensation and rent abatement expense, were $10.1 million for the third quarter of 2018, compared to $17.4 million for the third quarter of 2017.
- Research and Development Expenses: GAAP research and development (R&D) expenses for the third quarter of 2018 were $8.3 million, compared to $10.8 million for the third quarter of 2017. The decrease was primarily a result of decreased clinical trial activities for OTIVIDEX versus the prior year period.
- Selling, General and Administrative Expenses: GAAP selling, general and administrative (SG&A) expenses in the third quarter of 2018 were $4.7 million, compared to $10.5 million for the third quarter of 2017. The decrease was primarily a result of reduced selling expenses due to the discontinuation of promotional support for OTIPRIO.
- Financial Guidance: Otonomy reaffirms its expectations that GAAP operating expenses for 2018 will be in the range of $52-$57 million, and that non-GAAP operating expenses for 2018 will be in the range of $40-$45 million.
Additionally, the company announced anticipated upcoming milestones -
- By the end of 2018, select a candidate for clinical development for both OTO-5XX and OTO-6XX hearing loss programs.
- In first half of 2019, initiate a Phase 1/2 clinical trial of OTO-313 in tinnitus patients.
- In first half of 2019, initiate a Phase 1/2 clinical trial of OTO-413 in hearing loss patients.
During the quarter, Otonomy announced multiple presentations related to the company's programs in hearing loss and tinnitus at the Society for Neuroscience Annual Meeting in San Diego. There will be two presentations demonstrating the therapeutic potential of OTO-413, and a single presentation related to OTO-313.
One of the OTO-413 presentations was selected as a Neuroscience 2018 Hot Topic.
“The selection of our OTO-413 presentation as a Hot Topic at the 2018 Society for Neuroscience Annual Meeting and the recent workshop on pediatric CIHL highlight the important unmet medical need addressed by our hearing loss programs,” said David A. Weber, Ph.D., president and CEO of Otonomy. “When taken together with our OTIVIDEX Phase 3 program for Ménière’s disease and OTO-313 program for tinnitus, we have the broadest product pipeline addressing the largest market opportunities in the untapped neurotology field. I look forward to further discussing our pipeline and upcoming milestones with investors in the coming months beginning with our review of the OTO-413 program on today's call."