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OTIC

Otonomy

$3.50

0.15 (4.48%)

07:49
09/13/17
09/13
07:49
09/13/17
07:49

Otonomy provides business update, to cut non-commercial workforce by one-third

Otonomy announced a set of immediate actions to preserve capital, extend its cash runway, and build shareholder value following the recent negative AVERTS-1 Phase 3 trial results for OTIVIDEX in Meniere's disease. The immediate steps the company is taking include the following: As previously announced, all development activities for OTIVIDEX have been suspended including termination of ongoing clinical trials and pre-registration support efforts. Data collected from the clinical trials will be reviewed to better understand the AVERTS-1 trial failure, advise any future development efforts in indications other than Meniere's disease, and support potential monetization of the asset; Following the suspension of OTIVIDEX development, the company has implemented a workforce reduction totaling approximately one-third of personnel not involved in OTIPRIO commercial support; Additionally, no clinical trials will be initiated during the remainder of this year. Timing for initiation of a Phase 2 clinical trial of OTO-311 in tinnitus patients and a Phase 3 registration trial for OTIPRIO in pediatric patients with acute otitis media with tympanostomy tubes, or AOMT, will be evaluated as part of the pipeline review and prioritization effort now underway; Cost savings from these actions are expected to total approximately $7M for the remainder of 2017, net of project wind-down expenses and severance payments. Total non-GAAP operating expenses are now expected to total $73M-$78M for 2017, reduced from previous guidance of $80M-85M, while GAAP operating expenses for 2017 are expected to total $95M-$100M, reduced from $103M-$108M; The company expects its cash balance to total $120M-$125M at the end of 2017; The company expects its cash burn to total less than $45 million in 2018, and that its current cash balance will fund the company into 2020. As discussed in the second quarter 2017 financial results news release and conference call, the company has recently completed its commercial reorganization, and efforts are underway to leverage the new sales team's pre-existing ENT relationships and familiarity with the hospital operating room setting to increase OTIPRIO utilization during ear tube surgery. In addition, the company continues to support review of the Supplemental New Drug Application acute otitis externa. The sNDA is currently under review by the FDA with a Prescription Drug User Fee Act action date of March 2, 2018. Preclinical development continues on multiple product candidates for the prevention and/or treatment of sensorineural hearing loss. This set of programs targets key mechanisms involved in the pathophysiology of hearing loss including age-related hearing loss. The company believes that these multiple acute and chronic indications collectively comprise the largest population of patients and market opportunity in the otology field.

OTIC Otonomy
$3.50

0.15 (4.48%)

08/30/17
08/30/17
DOWNGRADE

On The Fly: Top five analyst downgrades
Catch up on today's top five analyst downgrades with this list compiled by The Fly: 1. Otonomy (OTIC) downgraded to Neutral from Overweight at JPMorgan with analyst Anupam Rama citing the company's failed Phase 3 trial of Otividex. The analyst cut his price target for the shares to $8 from $28. 2. Arc Logistics (ARCX) downgraded to Hold from Buy at Stifel and SunTrust. 3. The Advisory Board (ABCO) downgraded to Hold from Buy at Canaccord with analyst Richard Close citing the announced transaction to split the company by selling the Healthcare business to UnitedHealth's (UNH) Optum unit and the Education Business to Vista Equity Partners. 4. CubeSmart (CUBE) downgraded to Market Perform from Outperform at Raymond James with analyst Jonathan Hughes saying he expects CubeSmart's outsized exposure to New York City MSA will be remain a headwind to revenue growth given elevated new supply coming online over the next 12-18 months. 5. Vornado (VNO) downgraded to Hold from Buy at Stifel with analyst John Guinee saying the company's development pipeline "sounds intriguing" but is comprised entirely of 2019 and later deliveries, leaving Vornado lacking near-term catalysts. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
08/30/17
PIPR
08/30/17
DOWNGRADE
PIPR
Neutral
Otonomy downgraded to Neutral from Overweight at Piper Jaffray
08/30/17
08/30/17
DOWNGRADE
Target $8

Neutral
Otonomy downgraded to Neutral after trial failure at Piper Jaffray
As previously reported, Piper Jaffray analyst Charles Duncan downgraded Otonomy to Neutral from Overweight and cut his price target on the stock to $8 from $32 after the company's phase 3 trial of OTIVIDEX in Meniere's missed its primary endpoint and didn't show an impact on any secondary endpoints. Duncan, who sees the news dealing a "clear credibility hit" to Otonomy, added that the "slow-going" launch of OTIPRIO is now perhaps the main value driver of the stock in the near-term.
08/31/17
RHCO
08/31/17
NO CHANGE
RHCO
Otonomy price target lowered to $15 from $45 at SunTrust
SunTrust analyst Edward Nash cut his price target on Otonomy after the company's Meniere's treatment failed to meet its endpoints and the company discontinued the program. Nash says that the stock is undervalued at current levels and he keeps a Buy rating on the shares.

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