Exhibit 99.1
FOR IMMEDIATE RELEASE
Otonomy Reports Third Quarter 2022 Financial Results and
Provides Corporate Update
Evaluation of strategic options to realize value from pipeline is ongoing
SAN DIEGO, November 10, 2022 -- Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today reported financial results for the quarter ended September 30, 2022 and provided an update on its product pipeline and corporate activities.
Otonomy Program and Corporate Activity Updates
Third Quarter Financial Highlights
Non-GAAP Operating Expenses
In this press release, Otonomy’s operating expenses are provided in accordance with generally accepted accounting principles (GAAP) in the United States and also on a non-GAAP basis. Non-GAAP operating expenses exclude stock-based compensation. Non-GAAP operating expenses are provided as a complement to operating expenses provided in accordance with GAAP because management believes non-GAAP operating expenses help indicate underlying trends in the company’s business, are important in comparing current results with prior period results and provide additional information regarding the company’s financial position. Management also uses non-GAAP operating expenses to establish budgets and operational goals that are communicated internally and externally and to manage the company’s business and to evaluate its performance. The attached financial information includes a reconciliation of GAAP operating expenses to Non-GAAP operating expenses and a reconciliation of GAAP operating expense guidance to Non-GAAP operating expense guidance.
About Otonomy
Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and has been utilized to develop products addressing important unmet medical needs with a current focus on hearing loss. For additional information please visit www.otonomy.com.
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 Otonomy. Forward-looking statements in this press release include, but are not limited to, statements regarding Otonomy’s evaluation of strategic options to realize value from its pipeline including both OTO-413 and OTO-825. Otonomy’s expectations regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties. Actual results may differ materially from those indicated by these forward-looking statements as a result of these risks and uncertainties, including but not limited to: Otonomy’s ability to successfully identify strategic options and consummate a strategic transaction to realize value from its pipeline; the risk of being delisted from Nasdaq for failure to meet Nasdaq’s continued listing requirements; Otonomy’s ability to obtain additional financing; Otonomy’s ability to implement measures to extend its cash runway and manage operating expenses; delays and disruption resulting from the COVID-19 pandemic and governmental responses to the pandemic, including current and future impacts to Otonomy’s operations; Otonomy’s ability to protect its intellectual property; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in Otonomy’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 10, 2022, and Otonomy’s future reports to be filed with the SEC. The forward-looking statements in this press release are based on information available to Otonomy as of the date hereof. Otonomy disclaims any obligation to update any forward-looking statements, except as required by law.
Contacts:
Investor Inquiries
ICR Westwicke
Robert H. Uhl
Managing Director
858.356.5932
robert.uhl@westwicke.com
###
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As of September 30, |
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As of December 31, |
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||
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2022 |
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2021 |
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||
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|
(unaudited) |
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|
|
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||
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 |
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|
21,397 |
|
|
|
54,907 |
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|
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2022 |
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2021 |
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|
2022 |
|
|
2021 |
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||||
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|
(unaudited) |
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|||||||||||||
Product sales, net |
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$ |
— |
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|
$ |
— |
|
|
$ |
— |
|
|
$ |
125 |
|
Costs and operating expenses: |
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Cost of product sales |
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— |
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|
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— |
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|
|
— |
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|
|
370 |
|
Research and development |
|
|
8,410 |
|
|
|
8,978 |
|
|
|
27,048 |
|
|
|
24,995 |
|
Selling, general and administrative |
|
|
3,431 |
|
|
|
3,501 |
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|
|
10,702 |
|
|
|
11,213 |
|
Total costs and operating expenses |
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|
11,841 |
|
|
|
12,479 |
|
|
|
37,750 |
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|
|
36,578 |
|
Loss from operations |
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|
(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 |
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per share, basic and diluted |
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|
68,128,113 |
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|
|
67,792,425 |
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|
|
68,008,741 |
|
|
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61,969,780 |
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2022 |
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|
2021 |
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|
2022 |
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|
2021 |
|
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|
|
(unaudited) |
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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 |
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|
|
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|
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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 |
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|
(1,368 |
) |
|
|
(1,766 |
) |
|
|
(5,056 |
) |
|
|
(5,540 |
) |
Non-GAAP operating expenses |
|
$ |
10,473 |
|
|
$ |
10,713 |
|
|
$ |
32,694 |
|
|
$ |
30,668 |
|