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Editor and Publisher ... Henry enters his twelve (12) year at Scimitar's RegMed Investors which aggregates, curates and creates bottom-line content weeding of regenerative medicine and cell therapy news to provide a customized, vetted selection of relevant and high-impact synthesis. He was VP -... More
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  • Cytomedix (OTC QX: CMXI) Q4/12 And FY12 Results 0 comments
    Mar 19, 2013 9:13 AM

    Net loss of $3.8 M or $0.04 per share

    A net loss of $3.8 M or $0.04 per share compared to a net income of $811 K or $0.02 per share in Q4/11. A net loss of $19.8 M or $0.24 per share in FY12 compared to a net loss of $3.9 M or $0.08 per share in FY11.

    Consolidated revenue of $2.1 M was comprised of product sales of $2 M and $100 K from licensing and royalty fees. This compares with $3 M in consolidated revenue recorded in Q4/11. The difference year over year was due to lower license fees in 2012, partly offset by higher product sales. Cost of sales increased to $1.08 M from $726 K in Q4/11. Gross margin on product sales declined to 47% in 4Q12 from 55% in Q4/11, primarily due to mix shift to lower margin machines and disposables sold to distributors in EU, the Middle East, and Australia. Gross profit on product sales was down to $1.01 M from $2.22 M in Q4/11. Operating expenses in Q4/12 were $4.6 M, a $2.6 M increase from Q4/11, primarily resulting from $1.5 M of legacy Aldagen business operating expense, salary increases (associated with new sales, marketing, operations, and administration positions), additional R&D expenses, stock compensation and general expenses associated with expanded commercial operations. Total R&D expenses were $931 K in compared to $7.9 K in Q4/11. Q4/12 G&A expenses increased to $1.5 M from $723.8 K in Q4/11. Loss from operations was $3.6 M from $291 J in Q4/11. The net loss increased to $3.83 M from $810.9 K. Cash used in operations was $4.2 M in Q4 and $11.4 M for FY12. Shares used to compute the net loss were 92.13 M shares.

    • Cash and cash equivalents of approximately $2.6 M. In 2/13, CMXI received $9.5 M of gross proceeds as part of a financing plan.

    Financing Note: CMXI in 2/13 fulfilled a $27.5 M comprehensive financing which including a tranched $7.5 M senior secured term loan facility, a $5 M equity raise, and a $15 M committed equity facility. Approximately $9.5 M of gross proceeds was received upon closing with commitments for up to an additional $18 M.

    FY12 Results: A net loss of $19.8 M or $0.24 per share in FY12 compared to a net loss of $3.9 M or $0.08 per share in FY11. Consolidated revenue of $10.6 M was comprised of product sales of $7.2 M and $3.3 M from licensing and royalty fees. This represents a 46% increase from the $7.2 M in consolidated revenue recorded in FY11, which was comprised of product sales of $5.9 M and $1.3 M from licensing fees. The $7.2 M in product revenues in 2012 included AutoloGel sales of $600 K and Angel sales of $6.6 M. Product sales growth of 23% over prior year was mainly driven by continuing commercial efforts to increase Angel sales. The 20% growth in Angel sales was driven by 8% growth domestically and 212% internationally. Gross margin on product sales for the year decreased to 46% from 54% in 2011. The decrease was primarily due to shift to lower margin machines and disposables sold to distributors in Europe, the Middle East, and Australia. Total R&D expenses were $3.4 M in 2012, as compared to $100 K in 2011. SG&A were $16.2 M, which included non-cash charges of $2.3 M, compared to $7.9 M in 2011, which included non-cash charges of $500 K. Shares used in computing the net loss were 81.85 M.

    FY12 Highlights:

    • Centers for Medicare & Medicaid Services (NYSE:CMS) has issued coding and reimbursement claims instructions for autologous PRP in non-healing chronic wounds;
    • CMS granted formal approval of the protocols for AutoloGel under Coverage with Evidence Development (CED);
    • A 2013 financing was executed to raise a total of up to $27.5 M including $9.5 M in initial gross proceeds, comprised of a registered equity offering, a senior secured term loan and a committed equity facility;
    • The Angel® Concentrated Platelet Rich Plasma (cPRP) System was approved for marketing in Australia;
    • CE Mark in EU was granted for the Angel cPRP System for processing blood and bone marrow aspirate;
    • The FDA granted approval for Angel for processing bone marrow aspirate. This approval significantly expands the ortho-biologic commercial opportunity for the Angel system, increasing the addressable market to include the 400 K spinal fusion procedures performed each year in the US;
    • A P2 clinical study, in collaboration with the NIH, was announced for ALD-301 (Bright Cells) in patients with an intermittent claudication indication associated with peripheral artery disease.

    The Bottom Line: A net loss of $19.8 M or $0.24 per share in FY12 compared to a net loss of $3.9 M or $0.08 per share in FY11. Product revenue increased $400 k; while consolidated revenue decreased $900 k from Q4/11 but, CMXI has a better cash position based on thee 3 tier financing. In FY12 consolidated revenue jumped $3.4 M while product revenue increased 23% but, the net loss for FY12 increased to $19.8 M or $0.24 per share compared with $3.9 M or $0.08 per share in FY11.

    There was double-digit growth in Angel and AutoloGel sales - having placed more than 500 Angel Systems on a worldwide basis. Nearly 40,000 patients are currently being treated with the Angel System on an annualized basis. This capital infusion provides CMXI with the necessary capital to fund the launch of AutoloGel under CED, sales expansion for the Angel cPRP System, business development and partnering activities, and completion of the RECOVER-Stroke P2 study. "Bright Cell" technology pipeline continues to advance. CMXI is enrolling patients in the RECOVER-Stroke Trial with ALD-401. This clinical trial is currently enrolling at 9 sites and is on track to complete enrollment by the end of the year. CMXI also signed an agreement with NIH to collaborate on a P2 clinical study with ALD-301 in patients with intermittent claudication, caused by peripheral arterial disease (PAD).

    Cytomedix (OTC: CMXI) closed FLAT at $0.53 … with a tight trading range of $0.52 to $0.53 with moderate but, increasing volume of 381.7 K shares on from Monday's closing price of $0.53 and on Friday's moderate 83.2 K share volume. The 50 day moving average is lower at $0.60 as the 200 day average had fallen to $0.75. Visibility is still an issue but the financing got done! 35.78 M shares are held by insiders with a weak institutional following of .1% <but, it is under a dollar>. Ranked a BUY with a 3-6 month target 0f $0.85 to $1.00!

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

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