Monday, June 02, 2014 7:01:44 PM
FDA Approved OMIDRIA for Eye Surgery; Launch Anticipated in H2; Reiterate OUTPERFORM and Increasing PT to $44
• Conference call for OMIDRIA at 4:30pm ET. Dial-in numbers include Domestic Toll-Free (866) 515-2910, International (617) 399-5124, (no code). Replay Domestic (888) 286-8010, International (617) 801-6888, ID# 68733741, webcast: www.omeros.com.
• Omeros announced FDA approval of OMIDRIATM. OMIDRIATM (OMS302) was approved on May 30 for maintaining pupil dilation during intraocular lens replacement surgery and reducing postoperative pain. The package insert is available online at www.omidria.com.
• Omeros has targeted launching OMIDRIATM in late summer/early fall. We previously projected launch in July, but have moved it to September 30 to be in line with guidance. This decreased our 2014 revenue estimate from about $14.9 million to about $7.2 million. We continue to project gross peak annual sales for OMIDRIA to achieve about $500MM in 2019.
• We continue to project full-year profitability in 2016. Omeros ended Q1:2014 with $52.2 MM in cash, which we estimate provides cash runway into Q4:2014. We project breakeven and full-year profitability in 2016 with about $150 million in revenues.
• Next: US launch of OMIDRIA in late summer/early fall and potential EU approval in H2 2014.
• We are maintaining an OUTPERFORM rating and raising our price target to $44 from $37. By increasing our multiple to 9x from 8x for FDA approval of OMIDRIATM (offset by delaying our launch date from July to September) our price target for OMER goes to $44 from $37. We calculate our 12-month price target by projecting our present day fair value by 12 months. Our present day fair value is based on a sum-of-parts with each part’s value calculated using a 30% annual discount from our net peak annual sales estimate to present day for each product and indication in the clinic, then applying a 1-10x multiple depending on stage of development to reflect risk.
Thanks to ariadndndough for this information.
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