ROCKVILLE, Md., March 29, 2010 (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 12 months ended December 31, 2009.
Financial highlights for the fourth quarter of 2009 include the following (all comparisons are with the fourth quarter of 2008):
- Total revenues of $419,000, down 22%
- Royalty revenue of $352,000, down 31%
- Product sales of $67,000, up 131%
- Gross margin of 75%, up six percentage points
- Net loss to common stockholders of $1.10 million or ($0.03) per share, improved from a net loss of $4.71 million or ($0.14) per share
Other highlights of the fourth quarter and recent weeks include:
- The endorsement of the AutoloGel™ System in "Hair Transplant Forum International," in an article by internationally renowned hair restoration specialist, Robert J. Reese, D.O., who suggested that the application of platelet rich plasma (PRP) containing physiologic concentrations of platelets, such as the AutoloGel System, is most appropriate to speed wound healing and foster hair growth.
- The addition of Craig B. Mendelsohn, M.D., J.D., Vice President and Deputy General Counsel for the American Red Cross, to the Company's Board of Directors, providing significant FDA expertise with a focus on medical device law, legal affairs and regulatory affairs.
- Positive clinical data demonstrating the benefit of the AutoloGel 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.
Financial highlights for the 2009 full year include the following (all comparisons are with the 2008 full year):
- Total revenues of $2.07 million, down 1%
- Royalty revenue of $1.84 million, down 8%
- Product sales of $226,000, up 124%
- Gross margin of 78%, up seven percentage points
- Net loss to common stockholders of $3.45 million or ($0.10) per share, improved from a net loss of $7.68 or ($0.24) per share
Commenting on the financial results, Martin P. Rosendale, Chief Executive Officer of Cytomedix, said, "2009 was a year of transition and accomplishment for Cytomedix. We successfully implemented a new commercial strategy, invested in developing advances to our system's technology, continued to build the body of data in support of the use of and reimbursement for the AutoloGel System in wound healing, broadened our commercial footprint into Asian markets and made inroads toward expanding the AutoloGel System into other clinical indications, such as hair restoration surgery. We also strengthened our financial position with a capital raise that allowed us to fund our strategic growth plans."
Mr. Rosendale added, "We are particularly encouraged by the growth in product sales as they support the strategic shift in our commercial strategy to focus on the clinical and scientific underpinnings of our AutoloGel System to successfully heal previously untreatable and chronic wounds. We expect that our growing product sales and successful clinical outcomes, along with increasing legislative and advocacy group support will combine to provide a compelling submission for reimbursement reconsideration by the Centers for Medicare and Medicaid Services (CMS), which we expect to file later this year."
In an update on the Company's regulatory filing for orthopedic indications, Mr. Rosendale noted, "During the third quarter of 2009, we filed a 510(k) application with the U.S. Food and Drug Administration (FDA) for our Platelet Separation System in orthopedic indications. This new system features several enhancements to our commercial AutoloGel System and streamlines the process to produce PRP gel. Subsequently the FDA requested additional data regarding sterility and stability. In parallel we have made significant strides in developing an even more advanced separation system that further enhances the clinical efficiency and removes exposure to outside air. We intend to move forward with the final development of this more advanced Platelet Separation System and expect to file a 510(k) by year end, which is likely to be only a few months later than the time we would have in-hand the data requested by FDA on our pending submission. As such we are not likely to further support the pending application. Packaging enhancements designed to streamline the preparation of AutoloGel should be available to customers in the second quarter of 2010."
"We look forward to presenting data at the upcoming Symposium on Advanced Wound Care (SAWC) Spring meeting where there will be six poster presentations and one podium presentation on the clinical benefits of the AutoloGel System in managing and healing chronic wounds. This is an important meeting attended by the leading physicians and healthcare administrators who manage and pay for chronic wound care, which now represents nearly $20 billion in the U.S. annually."
"We continue to seek partnerships that will allow us to expand our clinical and commercial footprint for the AutoloGel System, so that over time we will replace royalty revenue lost due to the patent that expired in November 2009," concluded Mr. Rosendale.
Fourth Quarter Results
Total revenues for the fourth quarter of 2009 were $419,000, down 22% from total revenues of $536,000 in the fourth quarter of 2008, reflecting lower royalty revenue offset by higher product sales. Product sales increased 131% to $67,000 during the fourth quarter of 2009 from $29,000 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 $352,000 decreased 31% from $507,000 for the fourth quarter 2008 due to the late November expiration of the patent underlying our royalty agreements.
Gross margin was 75% for the 2009 fourth quarter, up from 69% for the 2008 fourth quarter, primarily driven by a mix shift toward product sales which have historically carried a higher margin than royalty revenues.
Operating expenses in the fourth quarter of 2009 decreased 72% to $1.41 million from $5.10 million in the prior year quarter, due primarily to an impairment charge with respect to goodwill and patents of approximately $3.54 million taken in fourth quarter of 2008, as well as by lower expenses in the fourth quarter of 2009.
The net loss to common stockholders for the fourth quarter of 2009 was $1.10 million or ($0.03) per share, compared with a net loss to common stockholders of $4.71 million or ($0.14) per share reported for the fourth quarter of 2008.
Cash and cash equivalents as of December 31, 2009 were $2.11 million, compared with $4.03 million as of December 31, 2008. The Company used $646,000 in cash to fund operating activities during the fourth quarter of 2009.
Full Year Results
Total revenues for fiscal year ended December 31, 2009 were $2.07 million, down 1% from total revenues of $2.09 million in the 2008 fiscal year, primarily the result of higher product sales offset by lower royalty revenue that ceased in late-November 2009. Product sales of $226,000 increased 124% compared with $101,000 during fiscal 2008, reflecting the positive response to the Company's shift in its commercial strategy beginning in January 2009. Royalty revenue of $1.84 million declined 8% compared with $1.99 million for the same period in 2008, largely due to the expiration of the patent underlying these royalty agreements.
Gross margin for 2009 was 78%, an increase from 71% for 2008, and was primarily driven by a shift within the Company's royalty revenue to higher margin royalty contracts.
Operating expenses for 2009 decreased 46% to $5.06 million from $9.38 million for 2008, due primarily to an impairment charge with respect to goodwill and patents of approximately $3.54 million in the fourth quarter of 2008. Lower operating expenses in 2009 were also the result of lower salaries and bonus expense, lower consulting and professional fees, and lower general and administrative costs somewhat offset by higher trials and studies expense in 2009.
The net loss to common stockholders for 2009 was $3.45 million or ($0.10) per share, compared with a net loss to common stockholders for 2008 of $7.68 million or ($0.24) per share.
For additional information, please refer to the Company's Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 29, 2010.
Conference Call
The Company will conduct a conference call to discuss these results beginning at 10:00 a.m. Eastern time on Tuesday, March 30, 2010. Shareholders and other interested parties may participate in the call by dialing 800-884-5695 (domestic) or 617-786-2960 (international) and entering passcode 18617657. 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 April 6, 2010 by dialing 888-286-8010 (domestic) or 617-801-6888 (international) and entering passcode 64458581. The call also will be archived for 90 days at www.streetevents.com, www.fulldisclosure.com and www.cytomedix.com.
About Cytomedix
Cytomedix is a biotechnology company that develops, sells, and licenses regenerative biological therapies, to primarily address the areas of wound care, inflammation, and angiogenesis. The Company currently markets the AutoloGel™ System, a device for the production of platelet rich plasma ("PRP") gel derived from the patient's own blood. The AutoloGel™ System is cleared by the Food and Drug Administration ("FDA") for use on a variety of exuding wounds. The Company is currently pursuing a multi-faceted strategy to penetrate the chronic wound market with its AutoloGel™ System. We are also pursuing opportunities for the application of AutoloGel™ and PRP technology into other markets such as hair transplantation and orthopedics, as well as actively seeking complementary products for the wound care market. The Company also seeks to monetize other product candidates in its pipeline through strategic partnerships, out-licensing, or sale. Most notably is its anti-inflammatory peptide (designated "CT-112") that has shown promise in pre-clinical 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™ 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 | ||
| December 31, | December 31, | |
| 2009 | 2008 | |
| ASSETS | ||
| Current assets | ||
| Cash | $ 2,107,499 | $ 4,027,026 |
| Short-term investments, restricted | 52,672 | -- |
| Accounts and royalties receivable, net | 180,560 | 390,739 |
| Patent settlements receivable, current portion | -- | 102,618 |
| Prepaid expenses, inventory, and other current assets | 166,731 | 190,720 |
| Total current assets | 2,507,462 | 4,711,103 |
| Property and equipment, net | 84,623 | 87,389 |
| Total assets | $ 2,592,085 | $ 4,798,492 |
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||
| Current liabilities | ||
| Accounts payable and accrued expenses | $ 1,037,894 | $ 1,325,325 |
| Deferred revenues, current portion | -- | 197,344 |
| Dividends payable on Series A and Series B preferred stock | 7,285 | 7,243 |
| Total current liabilities | 1,045,179 | 1,529,912 |
| Other liabilities | -- | 123,241 |
| Total liabilities | 1,045,179 | 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 - 97,663 and 90,217 shares, respectively, liquidation preference of $97,663 and $90,217, respectively |
10 | 9 |
|
Series B Convertible preferred stock; $.0001 par value, authorized 5,000,000 shares; 2009 and 2008 issued and outstanding - 65,784 and 92,300 shares, respectively, liquidation preference of $65,784 and $92,300, respectively |
7 | 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 - 37,273,628 shares; 2008 issued and outstanding -- 33,962,623 shares |
3,727 | 3,396 |
| Additional paid-in capital | 44,074,575 | 42,219,802 |
| Accumulated deficit | (42,531,413) | (39,077,878) |
| Total stockholders' equity | 1,546,906 | 3,145,339 |
| Total liabilities and stockholders' equity | $ 2,592,085 | $ 4,798,492 |
| CYTOMEDIX, INC. | ||||
| STATEMENTS OF OPERATIONS | ||||
| Year Ended | ||||
| December 31, | ||||
| 2009 | 2008 | |||
| Revenues | ||||
| Sales | $ 226,212 | $ 100,983 | ||
| Royalties | 1,839,972 | 1,989,754 | ||
| Total revenues | 2,066,184 | 2,090,737 | ||
| Cost of revenues | ||||
| Cost of sales | 58,690 | 16,764 | ||
| Cost of royalties | 400,115 | 584,256 | ||
| Total cost of revenues | 458,805 | 601,020 | ||
| Gross profit | 1,607,379 | 1,489,717 | ||
| Operating expenses | ||||
| Salaries and wages | 2,183,082 | 2,617,646 | ||
| Consulting expenses | 235,929 | 312,822 | ||
| Professional fees | 709,479 | 834,834 | ||
| Trials and studies | 227,490 | 145,713 | ||
| General and administrative expenses | 1,700,863 | 1,929,551 | ||
| Impairment of goodwill and patents | -- | 3,543,205 | ||
| Total operating expenses | 5,056,843 | 9,383,771 | ||
| Loss from operations | (3,449,464) | (7,894,054) | ||
| Other income | ||||
| Interest income, net | 9,764 | 156,609 | ||
| Other gain | 1,116 | 5,350 | ||
| Patent litigation settlements, net | -- | 71,346 | ||
| Total other income | 10,880 | 233,305 | ||
| Loss before provision for income taxes | (3,438,584) | (7,660,749) | ||
| Income tax provision | -- | -- | ||
| Net loss | (3,438,584) | (7,660,749) | ||
| Preferred dividend on: | ||||
| Series A preferred stock | 7,738 | 7,773 | ||
| Series B preferred stock | 7,213 | 7,174 | ||
| Net loss to common stockholders | $ (3,453,535) | $ (7,675,696) | ||
| Loss per common share -- | ||||
| Basic and diluted | $ (0.10) | $ (0.24) | ||
| Weighted average shares outstanding -- | ||||
| Basic and diluted | 35,116,049 | 32,515,784 | ||