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Athersys (ATHX) Q4/12 And FY12 Results

Net loss Q4/12 was $3.2 M of $0.07 per share

Net loss Q4/12 was $3.2 M or $0.07 compared to $4.3 M or $0.18 for Q4/11. Net loss was $14.7 M or $0.45 per share in FY12 compared to $13.7 M or $0.59 per share in FY11.

Q4/12 revenues were $2.3 M as compared to $2.6 M in the comparable period in Q4/11. The decrease reflects lower contract revenues from the Pfizer (NYSE:PFE) collaboration due to the end of the research performance period in 6/12. Included revenues are approximately $1.9 M related to milestone and technical support payments from the collaboration with RTI Biologics. R&D expenses decreased to $4.9 M in 2012, as compared to $5.6 M in Q4/11, primarily due to reduced clinical development expenses during the period. G&A expenses were $1.3 M compared to $1.2 M in Q4/11. Income from the change in the fair value of warrant liabilities was $1.1 M compared to $100 K in Q4/11. Shares used in computing the net loss ere 46.36 M versus 24.09 M in Q4/11.

At 12/31/12, ATHX had $25.5 M in cash and cash equivalents.

FY12 Results: Revenues decreased to $8.7 M from $10.3 M in FY11, primarily due to reduced revenues from the PFE collaboration. R&D expenses increased to $19.6 M in 2012 from $18.9 M in FY11 due to increased clinical and pre-clinical development costs, personnel costs and research supplies, partially offset by decreased patent legal fees. G&A expenses decreased to $4.8 M in 2012 from $4.9 M in FY11. Income from the change in the fair value of warrant liabilities was $2.4 M in 2012 compared to 800 K in FY11. Net other expenses were $1.2 M in 2012 compared to $900 K in FY11, which consists primarily of the final cash and stock-based milestone payments to former lenders. Cash used in operating activities was $17.7 M compared to $14.5 M in FY11. Shares used in computing the FY12 net loss were 32.55 M compared to 23.23 M in FY11.

Q4/12 and FY12 Highlights:

  • Raised $21.2 M net proceeds in Q4, including the full exercise of underwriters' over-allotment option,
  • Continued P2 clinical study with partner, Pfizer (PFE), involving administration of MultiStem(NYSE:R) cells to patients suffering from ulcerative colitis. This double blind, placebo-controlled trial will include approximately 130 patients with initial results expected in second half of 2013;
  • Advanced P2 clinical study of the administration of the MultiStem cell product to patients who have suffered ischemic stroke into large efficacy cohort of this double blind, placebo-controlled trial of 136 patients;
  • Developed and submitted to FDA a clinical trial plan for conducting a P2-3 study of MultiStem administration intended to both reduce the incidence and severity of graft-versus-host disease, or GvHD, and provide other benefits for patients undergoing hematopoietic stem cell transplantation;
  • Received 10 new patents during 2012 covering aspects of cell therapy technologies, including issuances in the US and other important jurisdictions;
  • Advanced partnering discussions on both the development of novel small molecule therapies to treat obesity and other conditions such as schizophrenia, acting through stimulation of the 5HT2c receptor, and on certain regenerative medicine programs.

The Bottom Line: Recorded revenues of $2.3 M and a net loss of $3.2 M in Q4/12 and for FY12, recorded revenues of $8.7 M and a net loss of $14.7 M. ATHX's Q4 EPS of -$0.07 beat by $0.03 … while revenue of $2.3 M beat by $0.6 M. ATHX is continuing their focus and resources on developing MultiStem to treat neurological conditions, inflammatory and immune disorders, and cardiovascular disease. PFE continues to advance the ongoing P2 clinical trial in inflammatory bowel disease. ATHX also initiated the 3rd and final cohort of a double-blind, placebo-controlled P2 clinical trial to evaluate the administration of MultiStem to patients who have suffered a moderate to moderately severe ischemic stroke following an independent safety monitoring committee review that found that MultiStem was safe and well tolerated in both high and low dosages in the initial patient treatment groups. In a significant extension of the treatment window currently required by standard of care, ATHX is treating patients 1 to 2 days after the stroke has occurred, which is believed to be a clinically practical time frame. In previously published work, ATHX have seen that the administration of a single dose of MultiStem in pre-clinical models even several days after a stroke resulted in significant and durable recovery. A "good cash" position of $25.5 M in cash but, the burn rate <with 1 - 2 years of cash> … should be increasing in FY13 based on … increased R&D and clinical development costs …

ATHX closed -$0.01 or -0.64% to $1.55 on 172.2 share volume. ATHX shares have been trading up since the 3/1 session at $1.51, up 51% from the $1.00 … it was trading on 12/20. Although, the RegMed sector's been slipping down and sideways. ATHX shares has appreciated recently on "speculative and unedited" SeekingAlpha posts. ATHX is UP in the after market $0.10 and $0.06 in the pre-market - +3.87%% to $1.61.

A "Speculative BUY" ranking ATHX … as the positive tone of the conference call resonated …hopefully, validating the "spoken word" re partnering potential. CEO Van Bokkelen wouldn't have been so vocal if he didn't have opportunities <definition - yet to have a valuation agreed to> going on … in several 'advancing partnership discussions" - BUT, ATHX has "cried wolf" before … and the market will "crucify" him if he does not deliver!

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.