Reports the Quarter – Lowering PT from $10.00, to $9.00, based on adjustments to both current revenue and trial enrollment timelines. BARDA progress should be a positive event ahead.
Ø Cytori had revenues of just $1.4M, below our reduced expectations, against expenses of $10.5M. The company ended the quarter with $12.8M in cash and $3.6M in receivables. We also note that Cytori entered into a sales agreement with Cowen and Company, under which it may offer and sell shares of common stock having an aggregate offering price of up to $40M, an “ATM” facility.
Ø BARDA Set to Advance. Cytori and BARDA have scheduled an in-process review meeting on June 10, 2014, to consider expanded funding to Cytori under the contract. A favorable review from this meeting may lead to additional contract revenue for a U.S. clinical trial program in thermal burn injury.
Ø We remain focused on fundamentals, highlighted as follows:
o ATHENA is enrolling, now in 10 sites, and the first ATHENA II sites are open. Timelines are pushed back but are now realistic (two to four patients per month); ATHENA I fully enrolls at N=45 patients. Once fully enrolled, the plan will be to transition those sites to ATHENA II sites.
o Achieved all three planned contract milestones related to the BARDA contract, and a review meeting is now set for June 10, 2014. The outcome and funding could be transformative.
2014 Operating Goals
o Complete ATHENA enrollment (2014) and make substantial enrollment progress in ATHENA II (both trials have begun)
o Advance BARDA contract into the next phases, including a U.S. feasibility trial and expanded research and development
o Achieve approval for the Celution System in China
o Grow research product sales in existing and new markets through new partnerships and recent changes in Japanese regenerative medicine law
o Initiate additional “proof-of-concept” studies in additional indications based partly on investigator-sponsored data sets, such as hand manifestations associated with scleroderma
Ø Valuation. Basing the valuation on our assumptions in CMI, we expect 2020 EPS of $9.80, and discounting back at 30% yields a $9.00 price target.
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