Conference call and webcast today at 4:30 p.m. ET
SAN DIEGO, Feb. 27, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today reported financial results for the fourth quarter and year ended December 31, 2019 and provided an update on its product pipeline and corporate activities. The company will host a conference call and webcast today at 4:30 p.m. ET to discuss recent highlights and financial results.
“We have positioned Otonomy for a transformational year in 2020 with three clinical trial readouts including the Phase 3 trial of OTIVIDEX in Ménière’s disease, Phase 2 trial of OTO-313 in tinnitus, and Phase 1/2 trial of OTO-413 in hearing loss,” said David A. Weber, Ph.D., president and CEO of Otonomy. “In addition to these clinical-stage programs that address significant patient populations with high disease burden and no FDA-approved drug treatments, we are also advancing multiple preclinical programs including a gene therapy collaboration targeting congenital hearing loss. I am proud of the progress we have made across our pipeline, which is the broadest in the emerging neurotology field, and look forward to sharing updates during this catalyst rich year.”
Product Pipeline Update
Anticipated Upcoming Milestones
Board of Directors Updates
“I am delighted to welcome Ciara to the board and believe that Otonomy will benefit greatly from her experience in drug development, operations, patient advocacy management and corporate development for biopharmaceutical companies across multiple therapeutic areas,” added Dr. Weber. “I would also like to take this opportunity to express my sincere gratitude and appreciation for the long term service and significant contributions made by Heather. Since joining the board with our first syndicated venture financing, Heather’s active participation and thoughtful guidance to the company and its board throughout have been greatly appreciated.”
Fourth Quarter and Full Year 2019 Financial Highlights
Webcast and Conference Call
Otonomy management will host a webcast and conference call regarding this announcement at 4:30 p.m. ET/1:30 p.m. PT today. The live call may be accessed by dialing (877) 305-6769 for domestic callers and (678) 562-4239 for international callers with conference ID code number: 2048824. A live webcast of the call will be available online in the investor relations section of Otonomy’s website at www.otonomy.com and will be archived there for 30 days.
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 the 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 is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière’s disease, hearing loss, and tinnitus. 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, timing of results, patient recruitment and enrollment plans for, and design and conduct of, the Phase 3 clinical trial for OTIVIDEX, and expectations regarding submission for U.S. registration; timing of results, patient recruitment and enrollment plans for, and design and conduct of, the Phase 1/2 clinical trial for OTO-313; timing of results, patient recruitment and enrollment plans for, and design and conduct of, the Phase 1/2 clinical trial for OTO-413; expectations regarding the status, timing and nature of upcoming milestones; expectations regarding advancement of preclinical programs; the potential benefits of and activity under the collaboration agreement between AGTC and Otonomy, including but not limited to development and commercialization activity; expectations regarding operating expenses for 2020; expectations that current capital is 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, and will support company operations into 2021; and statements by Otonomy’s president and CEO. 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 limited operating history and its expectation that it will incur significant losses for the foreseeable future; Otonomy’s ability to accurately forecast financial results; Otonomy’s ability to obtain additional financing; Otonomy’s dependence on the regulatory success and advancement of its product candidates; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy’s ability to adequately demonstrate the safety and efficacy of its product candidates, the nonclinical and clinical results for its product candidates, which may not support further development, and challenges related to patient enrollment in clinical trials; Otonomy’s ability to obtain regulatory approval for its product candidates; the risks of the occurrence of any event, change or other circumstance that could give rise to the termination of the collaboration agreement between AGTC and Otonomy; the risks of the occurrence of any event, change or other circumstance that could impact Otonomy’s ability to repay or comply with the terms of the loan provided by Oxford Finance LLC; side effects or adverse events associated with Otonomy’s product candidates; Otonomy’s ability to successfully commercialize its product candidates, if approved; competition in the biopharmaceutical industry; Otonomy’s dependence on third parties to conduct nonclinical studies and clinical trials; Otonomy’s dependence on third parties for the manufacture of its product candidates; Otonomy’s dependence on a small number of suppliers for raw materials; Otonomy’s ability to protect its intellectual property related to its product candidates in the United States and throughout the world; expectations regarding potential therapy benefits, market size, opportunity and growth; Otonomy’s ability to manage operating expenses; implementation of Otonomy’s business model and strategic plans for its business, products and technology; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in Otonomy’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on February 27, 2020, 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:
Media Inquiries
Spectrum Science
Chloé-Anne Ramsey
Vice President
404.865.3601
cramsey@spectrumscience.com
Investor Inquiries
Westwicke ICR
Robert H. Uhl
Managing Director
858.356.5932
robert.uhl@westwicke.com
Otonomy, Inc. | |||||||
Condensed Balance Sheet Data | |||||||
(in thousands) | |||||||
As of December 31, | As of December 31, | ||||||
2019 | 2018 | ||||||
Cash and cash equivalents | $ | 25,194 | $ | 33,633 | |||
Short-term investments | 35,476 | 63,651 | |||||
Right-of-use assets | 15,465 | — | |||||
Total assets | 83,018 | 104,992 | |||||
Long-term debt, net | 14,967 | 14,764 | |||||
Leases, net of current | 15,320 | — | |||||
Total liabilities | 42,785 | 25,255 | |||||
Accumulated deficit | (459,893 | ) | (415,218 | ) | |||
Total stockholders’ equity | 40,233 | 79,737 | |||||
Otonomy, Inc. | |||||||||||||||
Condensed Statements of Operations | |||||||||||||||
(in thousands, except share and per share data) | |||||||||||||||
Three Months Ended | Years Ended | ||||||||||||||
December 31, | December 31, | ||||||||||||||
2019 | 2018 | 2019 | 2018 | ||||||||||||
(unaudited) | |||||||||||||||
Product sales, net | $ | 93 | $ | 208 | $ | 600 | $ | 745 | |||||||
Costs and operating expenses: | |||||||||||||||
Cost of product sales | 276 | 271 | 912 | 946 | |||||||||||
Research and development | 7,034 | 9,669 | 32,805 | 31,844 | |||||||||||
Selling, general and administrative | 3,625 | 3,580 | 11,690 | 20,008 | |||||||||||
Total costs and operating expenses | 10,935 | 13,520 | 45,407 | 52,798 | |||||||||||
Loss from operations | (10,842 | ) | (13,312 | ) | (44,807 | ) | (52,053 | ) | |||||||
Other (expense) income, net | (83 | ) | 467 | 132 | 1,685 | ||||||||||
Net loss | $ | (10,925 | ) | $ | (12,845 | ) | $ | (44,675 | ) | $ | (50,368 | ) | |||
Net loss per share, basic and diluted | $ | (0.36 | ) | $ | (0.42 | ) | $ | (1.45 | ) | $ | (1.65 | ) | |||
Weighted-average shares used to compute net loss per share, basic and diluted | 30,768,174 | 30,646,951 | 30,726,786 | 30,610,244 | |||||||||||
Otonomy, Inc. | |||||||||||||||
Reconciliation of GAAP to Non-GAAP Operating Expenses | |||||||||||||||
(in thousands) | |||||||||||||||
Three Months Ended | Years Ended | ||||||||||||||
December 31, | December 31, | ||||||||||||||
2019 | 2018 | 2019 | 2018 | ||||||||||||
GAAP operating expenses | |||||||||||||||
Research and development | $ | 7,034 | $ | 9,669 | $ | 32,805 | $ | 31,844 | |||||||
Selling, general and administrative | 3,625 | 3,580 | 11,690 | 20,008 | |||||||||||
Total GAAP operating expenses | 10,659 | 13,249 | 44,495 | 51,852 | |||||||||||
Non-GAAP adjustments | |||||||||||||||
R&D stock-based compensation expense | 183 | (1,075 | ) | (2,085 | ) | (4,447 | ) | ||||||||
SG&A stock-based compensation expense | (628 | ) | (1,375 | ) | (2,793 | ) | (7,955 | ) | |||||||
Total non-GAAP adjustments | (445 | ) | (2,450 | ) | (4,878 | ) | (12,402 | ) | |||||||
Non-GAAP operating expenses | $ | 10,214 | $ | 10,799 | $ | 39,617 | $ | 39,450 | |||||||
Otonomy, Inc. | |
Reconciliation of 2020 GAAP to Non-GAAP Operating Expense Guidance | |
(in millions) | |
GAAP operating expenses | $45 - $48 |
Non-GAAP adjustments | |
Stock-based compensation expense | $10 |
Non-GAAP operating expenses | $35 - $38 |