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Cytomedix, Inc. Message Board

  • donnyboyko donnyboyko May 10, 2013 7:31 AM Flag

    Great buying opportunity...

    GAITHERSBURG, MD--(Marketwired - May 9, 2013) - Cytomedix, Inc. (OTCQX: CMXI), a leading developer of biologically active regenerative therapies, today reported financial results for the three months ended March 31, 2013.

    First Quarter 2013 Financial Highlights (all comparisons are with the 2012 first quarter)

    Product revenue of $2.3 million compared with $1.7 million in the prior year, an increase of 34%.
    Net loss to common stockholders of $5.3 million, or ($0.05) per share. This compares to a net loss of $4.7 million, or ($0.07) per share in the prior year.
    Cash and cash equivalents of approximately $7.2 million at March 31, 2013. In February 2013, the Company received $9.5 million of gross proceeds at closing as part of a comprehensive financing plan.

    Clinical and Corporate Highlights for the First Quarter and Recent Weeks

    The Centers for Medicare & Medicaid Services (CMS) granted formal approval of the protocols for AutoloGel™ under Coverage with Evidence Development (CED).
    CMS issued coding and reimbursement claims instructions for AutoloGel in non-healing chronic wounds.
    The Angel® Concentrated Platelet Rich Plasma (cPRP) System was approved for marketing in Australia.
    The Company signed a three year agreement with Vibra Healthcare, LLC, an owner and operator of Long Term Acute Care (LTAC) hospitals and Inpatient Rehabilitation Hospitals (IRF). This agreement will facilitate the use of the AutoloGel System for the treatment of wounds at Vibra Healthcare facilities throughout the United States.
    A comprehensive 2013 financing was executed to raise up to a total of $27.5 million, including $9.5 million in initial gross proceeds.
    Steven A. Shallcross, CPA, was appointed as Executive Vice President, Chief Financial Officer, Secretary and Treasurer.

    Management Discussion

    "Product sales continued along a steady growth trend, and we are pleased to report total sales of nearly $2.3 million in the first quarter," said Martin Rosendale, Chief Executive Officer of Cytomedix. "Angel sales of $2.1 million were particularly strong, up 40% year over year. Both Angel and AutoloGel achieved double digit increases sequentially over the prior quarter. We have now placed more than 500 Angel Systems on a worldwide basis. Over 40,000 patients are currently being treated with the Angel System on an annualized basis."

    "We continue to make excellent progress towards reimbursement for AutoloGel which will be covered initially by CMS under the Coverage with Evidence Development (CED) program. We hit another important milestone during the quarter when CMS formally approved the clinical outcomes in the protocols we had submitted in response to the National Coverage Determination (NCD) memo. CMS has also issued coding and reimbursement instructions to its regional contractors. We expect to begin treating Medicare beneficiaries with AutoloGel shortly and will be recording revenues for those AutoloGel treatments soon after the CED implementation date of July 1st, 2013."

    "Our Bright Cell technology pipeline continues to move forward. Our clinical development plan includes completion of enrollment in the RECOVER-Stroke trial with top-line data available in the first half of 2014, and beginning enrollment in the Phase 2 PACE study with ALD-301 in patients with intermittent claudication. The RECOVER-Stroke trial is currently enrolling at 10 sites. The first 30 patients have been enrolled, and we expect to have the planned DSMB review soon."

    "In February 2013, we strengthened our balance sheet by entering into several financing transactions providing access to up to $27.5 million of capital. These included an equity raise, a tranched senior secured term loan facility, and a committed equity facility. We received approximately $9.5 million in initial gross proceeds with commitments for up to an additional $18 million. As such, we believe we will have sufficient cash to sustain the Company at least through 2013," he concluded.

    Financial Results
    Three-Month Period Ended March 31, 2013

    Total revenues were $2.3 million in the three months ended March 31, 2013, a decrease of approximately $0.7 million compared to the same period last year. The decrease was mostly due to license fee revenue of $1.3 million recognized in 2012 with respect to an option agreement with a top 20 global pharmaceutical company. Product sales in the quarter were $2.3 million, an increase of 34% compared with the same period last year.

    Gross margin on product sales decreased to 44% from 50% comparing the three months ended March 31, 2013, to the same period last year. Sales on lower margin products, specifically Angel machines sold to international distributors, made up a more significant portion of the product mix. This, along with the medical device excise tax which took effect in 2013, resulted in a decrease in gross margin on product sales. Overall gross margin decreased to 45% from 72%. The license fee recorded in the first quarter of 2012 had no associated cost of revenue and was the primary reason for the decline in overall gross margin year over year.

    First quarter cash margins on product sales were 52%. Cash margins on disposable products in the quarter were 56%. Cash margin is a non-GAAP financial measure, most directly comparable to the U.S. GAAP measure of gross margin, and should not be considered as an alternative thereto. Cytomedix defines cash margin as gross margin exclusive of patent amortization and depreciation expense, and it is a significant performance metric used by management to indicate cash profitability on product sales.

    Total operating expenses in the quarter were $6.0 million an increase of $1.1 million or 24% compared to the same period in 2012.

    Research & Development expenses were $0.9 million, an increase of $544,000 or 152% year over year. The increase was primarily due to research and development costs related to the ALD-401 Phase II clinical trial. Selling, general and administrative expenses were $5.1 million during the quarter, an increase of 14% over the $4.5 million reported in the same quarter in 2012.

    The Company recorded a net loss of $5.4 million, or ($0.05) per share in the three-month period ended March 31, 2013, compared to a net loss of $4.8 million, or ($0.07) per share in the comparable period in 2012.

    Cash and Liquidity
    Cash and cash equivalents were approximately $7.2 million at March 31, 2013. In February 2013, the Company entered into several financing transactions for up to $27.5 million overall, which included a tranched $7.5 million senior secured term loan facility, a $5 million equity raise, and a $15 million committed equity facility. Approximately $9.5 million of gross proceeds was received upon closing with commitments for up to an additional $18 million.

    Cash used in operating activities during the quarter was $4.2 million. There were approximately 104.3 million shares of common stock issued and outstanding as of March 31, 2013.

    Sentiment: Strong Buy

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CMXI
0.377-0.008(-2.08%)Aug 26 3:59 PMEDT

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