Otonomy, Inc. (NASDAQ:OTIC) Files An 8-K Costs Associated with Exit or Disposal ActivitiesItem 2.05
On November27, 2017, Otonomy, Inc. issued a press release announcing plans to focus its resources on its development programs and discontinue commercial support for its OTIPRIO product. A copy of the press release is attached as Exhibit99.1 and incorporated herein by reference.
Otonomy’s management, with the authorization of its Board of Directors, committed to discontinue commercial support for OTIPRIO on November20, 2017. The facts and circumstances leading to this action, the timing of this action and related matters are discussed in the attached press release.
Otonomy expects to incur approximately $4.0million of costs associated with the discontinuation of commercial support for OTIPRIO. These consist of approximately $3.0million in personnel-related termination costs and $1.0million in program contract termination costs. Otonomy expects that most of these costs and related cash expenditures will be incurred in the fourth quarter of 2017 and the first quarter of 2018.
Cautionary Note Regarding Forward Looking Statements
This Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements relate to the planned discontinuation of commercial support for OTIPRIO and the estimated costs of doing so. Estimates are inherently uncertain. Actual results may differ materially from these estimates as a result of, among other things, unexpected delays in implementing these actions, unexpected personnel-related termination costs, and unanticipated difficulties in terminating certain contracts and arrangements associated with OTIPRIO. Information regarding additional risks may be found in the section titled “Risk Factors” in Otonomy’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on November8, 2017. 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.
| Item 2.05 | Financial Statements and Exhibits. |
(d) Exhibits
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Exhibit No. |
Description |
| 99.1 | Press Release dated November27, 2017. |
OTONOMY, INC. ExhibitEX-99.1 2 d461463dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 FOR IMMEDIATE RELEASE Otonomy Announces Plan to Focus Resources on Development Programs Company to focus resources on completing OTIVIDEX clinical development to support U.S. regulatory approval for Ménières disease,…To view the full exhibit click here
About Otonomy, Inc. (NASDAQ:OTIC)
Otonomy, Inc. is a biopharmaceutical company. The Company focuses on the development and commercialization of therapeutics for diseases and disorders of the ear. The Company has developed a technology referred to as sustained-exposure that is designed to deliver drug that is retained in the ear for an extended period of time following a local administration. Its product candidates include OTIPRIO, OTO-104 and OTO-311. The Company’s product candidate, OTIPRIO, is used for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement (TTP) surgery. Its product candidate, OTO-104, is a sustained-exposure formulation of the steroid dexamethasone in development for the treatment of Meniere’s disease and other inner ear conditions. The Company’s product candidate, OTO-311, is a sustained-exposure formulation of the N-Methyl-D-Aspartate (NMDA) receptor antagonist gacyclidine in development for the treatment of tinnitus.