Cytomedix Reports Third Quarter Financial Results
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ROCKVILLE, Md., Nov. 11, 2009 (GLOBE NEWSWIRE) -- Cytomedix, Inc. (NYSE Amex: GTF), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, today announced financial results for the three and nine months ended September 30, 2009.
Financial highlights for the third quarter of 2009 include the following (all comparisons are with the third quarter of 2008):
* Total revenues of $538,000, up 8% * Royalty revenue of $494,000, up 4% * Product sales of $44,000, up 72% * Gross margin of 81%, up three percentage points * Net loss to common stockholders of $570,000 or ($0.02) per share, improved from a net loss of $806,000 or ($0.03) per share
Other highlights of the third quarter and recent weeks include:
* Positive clinical data demonstrating the benefit of the
Company's AutoloGel(TM) System to treat chronic wounds was
presented at two industry symposia
-- Clinical Symposia on Advances in Skin and Wound Care held in
San Antonio, Texas from October 22-25, 2009
-- National Association for Long Term Hospitals held in Las
Colinas, Texas from October 21-23, 2009
* Entered into a license and distribution agreement with Millennia
Holdings, Inc. ("Millennia") for the Company's AutoloGel(TM)
System in Japan
* Raised $1.50 million in a registered direct offering of the
Company's securities with qualified institutional investors and
high net worth individuals
* Filed a 510(k) premarket notification with the U.S. Food and
Drug Administration ("FDA") for clearance to market the
AutoloGel(TM) Platelet Separation System for use in orthopedics
Commenting on the quarter's results, Martin P. Rosendale, Chief Executive Officer of Cytomedix, said, "We are pleased with our performance during the third quarter of 2009, which showed progress in a number of critical areas. We continued to build upon our clinical data in support of the use of the AutoloGel(TM) System to treat chronic wounds, expanded our clinical and commercial footprint into the Asian markets with the Millennia agreement, filed for U.S. regulatory clearance with an enhanced kit component to our separation system and raised additional capital to allow us to continue to advance our strategic growth plans."
Mr. Rosendale continued, "While we are especially pleased with the 72% increase in AutoloGel(TM) System sales when compared with 2008 sales, those increases would have been higher were it not for the temporary suspension of sales to one of our largest customers while they formalized the inclusion of AutoloGel(TM) System guidelines for use into their wound care policies and procedures manual. The guidance will standardize AutoloGel(TM) System utilization across their entire network of long term acute care (LTAC) facilities. While this process impacted growth in the short term, it provides a potentially significant opportunity for us to expand sales of our AutoloGel(TM) System into their additional facilities longer term."
"Gaining access to long-term acute care hospital networks is one part of our strategy to penetrate the chronic wound care market. We recognize that widespread adoption of our AutoloGel(TM) System will be accelerated by Medicare coverage in the outpatient setting. We believe that the recently presented clinical studies, combined with the legislative interest and advocacy group support we have developed strongly enhance our currently planned submission for reconsideration of reimbursement with the Centers for Medicare and Medicaid Services, and we look forward to reporting on our continued progress in this area," concluded Mr. Rosendale.
Third Quarter Results
Total revenues for the third quarter of 2009 were $538,000, up 8% from total revenues of $499,000 in the third quarter of 2008, reflecting higher royalty revenue and product sales. Product sales increased 72% to $44,000 during the quarter from $26,000 in the prior year primarily as a result of the Company's revised sales and marketing campaign, which was launched in the first quarter of 2009. Royalty revenue of $494,000 increased 4% from $474,000 for the third quarter 2008.
Gross margin was 81% for the 2009 third quarter, up from 78% for the 2008 third quarter, driven by modest increases in the higher-margin royalty revenue and higher product revenue.
Operating expenses decreased 23% to $1.00 million from $1.29 million in the year-ago quarter. Salaries and wages declined 33% to $349,000 from $524,000 in the prior year, primarily due to lower bonus expense resulting from the reversal of accrued bonuses, partly offset by modestly higher salaries and higher non-cash equity-based compensation.
General and administrative expenses declined 12% to $426,000 from $483,000 in the prior year, primarily due to lower non-cash equity-based compensation and patent amortization as the Company wrote-off the remaining value of its patents in the fourth quarter of 2008, partly offset by increased marketing expenses.
The net loss to common stockholders for the third quarter of 2009 was $570,000 or ($0.02) per share, compared with a net loss to common stockholders of $806,000 or ($0.03) per share reported for the third quarter of 2008.
Cash and cash equivalents as of September 30, 2009 totaled $2.75 million, compared with $4.03 million as of December 31, 2008. The Company used $1.02 million in cash to fund operating activities during the third quarter of 2009.
Nine Month Results
Total revenues for the first nine months of 2009 were $1.65 million, up 6% from total revenues of $1.55 million in the first nine months of 2008, due to higher product sales. Product sales of $159,000 increased 120% compared with $72,000 in the first nine months of 2008. Royalty revenue of $1.49 million was nearly unchanged compared to the same period in 2008.
Gross margin for the first nine months of 2009 improved by six percentage points to 78% from 72% in the same period in 2008, driven by a shift within our royalty revenue to higher margin royalty revenue, partly offset by a shift in product revenue to lower margin reagent kits and a $14,000 write-off of obsolete inventory in the second quarter of 2009.
Operating expenses for the first nine months of 2009 decreased 15% to $3.65 million from $4.29 million for the first nine months of 2008.
The net loss to common stockholders for the 2009 nine-month period was $2.36 million or ($0.07) per share, compared with a net loss to common stockholders for the 2008 nine-month period of $2.96 million or ($0.09) per share.
For additional information, please refer to the Company's Quarterly Report on Form 10-Q which will be filed with the Securities and Exchange Commission.
Conference Call
The Company will conduct a conference call to discuss these results beginning at 10:00 a.m. Eastern time on Thursday, November 12, 2009. Shareholders and other interested parties may participate in the call by dialing 800-299-0433 (domestic) or 617-801-9712 (international) and entering passcode 29310211. The call will also be broadcast live on the Internet at www.streetevents.com, www.fulldisclosure.com and www.cytomedix.com.
A replay of the conference call will be accessible two hours after its completion through November 19, 2009 by dialing 888-286-8010 (domestic) or 617-801-6888 (international) and entering passcode 71771840. The call also will be archived for 90 days at www.streetevents.com, www.fulldisclosure.com and www.cytomedix.com.
About Cytomedix
Cytomedix develops, sells and licenses regenerative biological therapies including the AutoloGel(TM) System, a device for the production of Platelet Rich Plasma ("PRP") gel derived from the patient's own blood. The AutoloGel(TM) System is cleared by the U.S. Food and Drug Administration for use on a variety of exuding wounds. The Company is pursuing a multi-faceted strategy to penetrate the chronic wound market with its AutoloGel(TM) System. The Company is also moving forward with the development of other product candidates in its pipeline. Most notably is its CT-112 product, an anti-inflammatory peptide that has shown promise in preclinical testing. Additional information regarding Cytomedix is available at www.cytomedix.com.
Safe Harbor Statement
Statements contained in this communication not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix's actual results may differ materially due to a number of factors, many of which are beyond Cytomedix's ability to predict or control, including among others, viability and effectiveness of the Company's sales approach and overall marketing strategies, the outcome of development or regulatory review of CT-112, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, its ability to successfully commercialize its product in Japan under the terms of the license agreement, and Cytomedix's ability to execute on its strategy to market the AutoloGel(TM) System as contemplated. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason.
CYTOMEDIX, INC.
BALANCE SHEETS
September 30, December 31,
2009 2008
------------ ------------
(unaudited)
ASSETS
Current assets
Cash $ 2,753,894 $ 4,027,026
Short-term investments, restricted 52,500 --
Accounts and royalties receivable, net 500,991 390,739
Patent settlements receivable -- 102,618
Prepaid expenses, inventory, and other
current assets 236,905 190,720
------------ ------------
Total current assets 3,544,290 4,711,103
Property and equipment, net 93,747 87,389
------------ ------------
Total assets $ 3,638,037 $ 4,798,492
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable and accrued expenses $ 1,026,549 $ 1,325,325
Deferred revenues 35,881 197,344
Dividends payable on Series A and Series B
preferred stock 18,707 7,243
------------ ------------
Total current liabilities 1,081,137 1,529,912
Other liabilities -- 123,241
------------ ------------
Total liabilities 1,081,137 1,653,153
------------ ------------
Commitments and contingencies
Stockholders' equity
Series A Convertible preferred stock;
$.0001 par value, authorized 5,000,000
shares; 2009 and 2008 issued and
outstanding - 90,217 shares, liquidation
preference of $90,217 9 9
Series B Convertible preferred stock;
$.0001 par value, authorized 5,000,000
shares; 2009 and 2008 issued and
outstanding - 92,300 shares, liquidation
preference of $92,300 10 10
Series C Convertible preferred stock;
$.0001 par value, authorized 1,000,000
shares; 2009 and 2008 issued and
outstanding - 0.0 shares -- --
Common stock; $.0001 par value, authorized
65,000,000 shares; 2009 issued and
outstanding - 37,262,302 shares; 2008
issued and outstanding - 33,962,623
shares 3,726 3,396
Additional paid-in capital 43,986,754 42,219,802
Accumulated deficit (41,433,599) (39,077,878)
------------ ------------
Total stockholders' equity 2,556,900 3,145,339
------------ ------------
Total liabilities and stockholders' equity $ 3,638,037 $ 4,798,492
============ ============
CYTOMEDIX, INC.
STATEMENTS OF OPERATIONS
(unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
---------------------- ------------------------
2009 2008 2009 2008
---------- ---------- ----------- -----------
Revenues
Sales $ 43,935 $ 25,507 $ 159,238 $ 72,255
Royalties 494,378 473,864 1,487,518 1,482,424
---------- ---------- ----------- -----------
Total revenues 538,313 499,371 1,646,756 1,554,679
---------- ---------- ----------- -----------
Cost of revenues
Cost of sales 9,052 5,244 43,690 11,009
Cost of royalties 94,469 103,679 310,791 422,675
---------- ---------- ----------- -----------
Total cost of
revenues 103,521 108,923 354,481 433,684
---------- ---------- ----------- -----------
Gross profit 434,792 390,448 1,292,275 1,120,995
---------- ---------- ----------- -----------
Operating expenses
Salaries and wages 348,610 523,800 1,623,688 1,955,107
Consulting expenses 80,203 94,566 132,987 147,214
Professional fees 146,930 164,626 452,954 682,855
Trials and studies 188 28,034 179,304 28,034
General and
administrative
expenses 426,295 483,024 1,258,931 1,473,019
---------- ---------- ----------- -----------
Total operating
expenses 1,002,226 1,294,050 3,647,864 4,286,229
---------- ---------- ----------- -----------
Loss from operations (567,434) (903,602) (2,355,589) (3,165,234)
---------- ---------- ----------- -----------
Other income
(expenses)
Interest income
(expense), net (309) 37,737 10,216 136,428
Other gain 1,116 100 1,116 5,350
Patent litigation
settlements, net -- 62,796 -- 71,357
---------- ---------- ----------- -----------
Total other income 807 100,633 11,332 213,135
---------- ---------- ----------- -----------
Loss before provision
for income taxes (566,627) (802,969) (2,344,257) (2,952,099)
Income tax provision -- -- -- --
---------- ---------- ----------- -----------
Net loss (566,627) (802,969) (2,344,257) (2,952,099)
Preferred dividend
on:
Series A preferred
stock 1,952 1,814 5,745 5,934
Series B preferred
stock 1,846 1,710 5,719 5,294
---------- ---------- ----------- -----------
Net loss to common
stockholders $ (570,425) $ (806,493) $(2,355,721) $(2,963,327)
========== ========== =========== ===========
Loss per common share
-- Basic and
diluted $ (0.02) $ (0.03) $ (0.07) $ (0.09)
========== ========== =========== ===========
Weighted average
shares outstanding
-- Basic and
diluted 35,229,556 32,257,869 34,389,575 32,038,305
========== ========== =========== ===========
CONTACT: Cytomedix, Inc.
David Jorden, Executive Board Member
Martin Rosendale, CEO
(240) 499-2680
Lippert/Heilshorn & Associates
Anne Marie Fields
(212) 838-3777
afields@lhai.com
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