News & Events
Otonomy Reports Third Quarter 2022 Financial Results and Provides Corporate Update
Otonomy Program and Corporate Activity Updates
- In
August 2022 ,Otonomy announced that OTO-313 demonstrated no clinically meaningful improvement versus placebo for primary and secondary endpoints in a Phase 2 clinical trial in tinnitus patients.
- Based on these results,
Otonomy discontinued development of OTO-313 and implemented other measures to extend its cash runway. These included a reduction of its workforce by approximately 55%, with the majority of the reduction completed by the end of August.
- In
October 2022 ,Otonomy announced that the clinical evaluation of higher doses for OTO-413 in patients with hearing loss demonstrated no clinically meaningful improvement for patients from baseline across multiple speech-in-noise hearing tests.
- Following these results, the company initiated an evaluation of strategic options to realize value from its pipeline including both OTO-413 and OTO-825. Strategic options could include a possible merger, business combination, sale of assets, wind-down, liquidation and dissolution or other strategic transaction. While those evaluations are ongoing,
Otonomy has paused its product development activities and taken other steps to reduce costs in order to preserve its cash resources.
Third Quarter Financial Highlights
- Cash Position: Cash and cash equivalents totaled
$40.1 million as ofSeptember 30, 2022 , compared to$77.4 million as ofDecember 31, 2021 . InOctober 2022 , the term loan withOxford Finance LLC was terminated in connection with the company’s payment of all amounts owed under the agreement totaling approximately$17.0 million .
- Operating Expenses: GAAP operating expenses were
$11.8 million for the third quarter of 2022, compared to$12.5 million for the third quarter of 2021. Non-GAAP operating expenses, which exclude stock-based compensation, were$10.5 million for the third quarter of 2022, compared to$10.7 million for the third quarter of 2021.
- Research and Development Expenses: GAAP research and development (R&D) expenses for the third quarter of 2022 were
$8.4 million , compared to$9.0 million for the third quarter of 2021. The decrease for the quarter was primarily due to lower third-party development costs for Otonomy’s product candidates.
- Selling, General and Administrative Expenses: GAAP selling, general and administrative (SG&A) expenses in the third quarter of 2022 were
$3.4 million , compared to$3.5 million for the second quarter of 2021.
Non-GAAP Operating Expenses
In this press release, Otonomy’s operating expenses are provided in accordance with generally accepted accounting principles (GAAP) in
About
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
Contacts:
Investor Inquiries
ICR Westwicke
Managing Director
858.356.5932
robert.uhl@westwicke.com
Condensed Balance Sheet Data | |||||||
(in thousands) | |||||||
As of |
As of |
||||||
2022 | 2021 | ||||||
(unaudited) | |||||||
Cash and cash equivalents | $ | 40,146 | $ | 77,412 | |||
Right-of-use assets | 11,481 | 12,696 | |||||
Total assets | 57,527 | 95,637 | |||||
Debt, current | 16,130 | - | |||||
Long-term debt, net of current | - | 15,997 | |||||
Leases, net of current | 10,879 | 12,400 | |||||
Total liabilities | 36,130 | 40,730 | |||||
Accumulated deficit | (594,486 | ) | (555,805 | ) | |||
Total stockholders' equity | 21,397 | 54,907 |
Condensed Statements of Operations | |||||||||||||||
(in thousands, except share and per share data) | |||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
(unaudited) | |||||||||||||||
Product sales, net | $ | - | $ | - | $ | - | $ | 125 | |||||||
Costs and operating expenses: | |||||||||||||||
Cost of product sales | - | - | - | 370 | |||||||||||
Research and development | 8,410 | 8,978 | 27,048 | 24,995 | |||||||||||
Selling, general and administrative | 3,431 | 3,501 | 10,702 | 11,213 | |||||||||||
Total costs and operating expenses | 11,841 | 12,479 | 37,750 | 36,578 | |||||||||||
Loss from operations | (11,841 | ) | (12,479 | ) | (37,750 | ) | (36,453 | ) | |||||||
Other expense, net | (207 | ) | (401 | ) | (931 | ) | (1,149 | ) | |||||||
Net loss | $ | (12,048 | ) | $ | (12,880 | ) | $ | (38,681 | ) | $ | (37,602 | ) | |||
Net loss per share, basic and diluted | $ | (0.18 | ) | $ | (0.19 | ) | $ | (0.57 | ) | $ | (0.61 | ) | |||
Weighted-average shares used to compute net loss per share, | |||||||||||||||
basic and diluted | 68,128,113 | 67,792,425 | 68,008,741 | 61,969,780 | |||||||||||
Reconciliation of GAAP to Non-GAAP Operating Expenses | |||||||||||||||
(in thousands) | |||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
(unaudited) | |||||||||||||||
GAAP operating expenses | |||||||||||||||
Research and development | $ | 8,410 | $ | 8,978 | $ | 27,048 | $ | 24,995 | |||||||
Selling, general and administrative | 3,431 | 3,501 | 10,702 | 11,213 | |||||||||||
Total GAAP operating expenses | 11,841 | 12,479 | 37,750 | 36,208 | |||||||||||
Non-GAAP adjustments | |||||||||||||||
R&D stock-based compensation expense | (463 | ) | (823 | ) | (2,241 | ) | (2,443 | ) | |||||||
SG&A stock-based compensation expense | (905 | ) | (943 | ) | (2,815 | ) | (3,097 | ) | |||||||
Total non-GAAP adjustments | (1,368 | ) | (1,766 | ) | (5,056 | ) | (5,540 | ) | |||||||
Non-GAAP operating expenses | $ | 10,473 | $ | 10,713 | $ | 32,694 | $ | 30,668 | |||||||

Source: Otonomy, Inc.