Cytori Therapeutics (NASDAQ: CYTX) reports its 2012 business and financial results and provides an outlook for 2013. The Company achieved record total revenues for the year and fourth quarter ended December 31, 2012 of $14.5 million and $7.3 million, respectively, compared to $10.0 million and $2.8 million, respectively, for the same periods in 2011.
Cytori’s 2012 and year-to-date milestones include the following:
- Initiated enrollment in the ATHENA U.S. refractory heart failure trial; all six centers are actively screening patients, enrollment is on track to be complete mid-summer
- Awarded contract with BARDA, a division of the U.S. Health and Human Services, worth up to $106 million to develop a novel cell-based treatment of thermal burns combined with radiation injury
- Obtained Class I device clearance in Japan, opening the Japanese market and increasing fourth quarter revenues
- Opened EU vascular market with CE Mark claims for intravascular delivery (Intravase®)
- Expanded CE Mark claims for multiple indications including cryptoglandular fistulae and tissue ischemia
- Amended and resumed enrollment in the ADVANCE European heart attack trial
- Achieved $9.1 million in product and contract revenue, including a record $4.3 million in the fourth quarter
- Grew Celution® and StemSource® System shipments by 46% year-over-year
- Increased patent portfolio year-over-year by 36% with the issuance of 15 patents worldwide, bringing the total number of global patents to 57 with 75 additional applications under review
- Recruited Steven Kesten, M.D., as Executive Vice President and Chief Medical Officer
- Raised $21.4 million in net proceeds from public offering of shares, including $2.8 million in net proceeds in January 2013 from the exercise of the full over-allotment option
“We made substantial progress in 2012 across three key areas of our business: our cardiac pipeline, our recently awarded government contract and our commercial operations,” said Chris Calhoun, Chief Executive Officer of Cytori. “The specific developments include the initiation of the ATHENA trial, a significant contract with the Biomedical Advanced Research Authority (BARDA) related to thermal burns, and growing revenue opportunities through important European and Japanese regulatory approvals, which was reflected in strong fourth quarter sales and which we see significantly contributing to revenue growth in 2013 and beyond.