ROCKVILLE, MD., September 9, 2009 – Cytomedix, Inc. (NYSE Alternext US: GTF) announced today that Chief Executive Officer, Martin Rosendale, issued the following letter to shareholders providing a general corporate update:
To Our Stockholders:
It is with pleasure and a sense of long-term optimism that I report to you on the significant progress made at Cytomedix during the first half of 2009 to expand our presence in the wound healing market. We demonstrated momentum in all areas critical to building a sustainable growth business, namely substantially growing product sales, advancing our regulatory strategy and strengthening our balance sheet.
Sales of our AutoloGel™ System during the second quarter of the year increased 165% over last year’s second quarter and were up 72% compared with the first quarter of 2009. We continued to present and publish clinical data that support our clinician-focused education and marketing efforts. In addition, we advanced our regulatory strategy and recently filed a 510(k) application with the U.S. Food and Drug Administration (FDA) for our Platelet Separation System in orthopedic indications. In tandem, we made progress with our review of the clinical options for CT-112 and are establishing a cogent strategy to advance this product through the regulatory process and into the clinic.
We strengthened our balance sheet with the recently announced $1.5 million registered direct offering, which will help support our plans to build Cytomedix into a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis.
Financial highlights of the second quarter and first half of 2009, compared with the corresponding prior-year period, include:
- Total revenues for the second quarter up 33% to $569,000, for the first half up 5% to $1.11 million
- Royalty revenue for the second quarter up 24% to $496,000, for the first half down 2% to $993,000
- Product sales for the second quarter up 165% to $73,000 (up 72% over the first quarter), for the first half up 147% to $115,000
- Gross margin for the second quarter of 79% up from 75%, for the first half 77% up from 69%
- Net loss attributable to common stockholders for the second quarter of $891,000 or ($0.03) per share, compared with a loss of $1.25 million or ($0.04) per share; for the first half a loss of $1.79 million or ($0.05) per share, compared with a loss of $2.16 million or ($0.07) per share.
While the impressive percentage increases in product sales are off a modest base, the underlying momentum resulting from positive evaluation outcomes at numerous facilities and supportive feedback from well-regarded key opinion leaders in the wound care industry is very encouraging.
Cytomedix had cash and cash equivalents of $2.4 million as of June 30, 2009, which does not include the $1.5 million of incremental capital mentioned above. We used $1.6 million in cash to fund operating activities during the first six months of the year, in keeping with our forecasts.
We believe we have sufficient capital to support our near-term commercialization strategy for the AutoloGel System in wound healing. Driving product sales is doubly important as our base platelet releasate patent loses exclusivity late this year, and consequently, our royalty derived cash flows will cease early next year. Early results from our renewed clinical and scientific commercialization strategy are very encouraging as evidenced by our financial results, and we are confident that our strategy will continue to be successful as we expand its scope and build on its momentum.
The AutoloGel System
As I have discussed previously, during the first quarter of this year we shifted our commercial strategy for the AutoloGel System to emphasize clinical outcomes and scientific data. Customers appear to be receptive to the scientific message and are intensely interested in the actual clinical outcomes.
As our clinical evaluations proceed, we have been collecting outcomes data to share with potential customers, and also intend to use this information in our strategic reimbursement initiatives discussed below. Through June, we have collected and analyzed data on 65 wounds of differing types across 50 patients and 11 facilities. Importantly, the average duration of these wounds before the first treatment with AutoloGel was 48 weeks. The AutoloGel System produced a favorable clinical response in 97% of the wounds treated with a mean reduction in wound volume of 62% in less than three weeks of treatment on average.
As part of this change, we continue to publish and present compelling clinical, scientific and economic data in support of the adoption of the AutoloGel System as an effective wound healing therapy, including the publication in WOUNDS of a paper entitled, “Double impact: Synergism in using Negative Pressure Wound Therapy (NPWT) with alternated applications of Autologous Platelet Derived Growth Factors in treating post acute surgical wounds.” This study demonstrated that the AutoloGel System can be used effectively in combination with other widely used wound care therapies such as NPWT. This finding is important as the ability of the AutoloGel System to be complementary to existing therapies that physicians are comfortable using can help accelerate acceptance.
In addition we presented two clinical posters demonstrating positive outcomes using the AutoloGel System in challenging chronic wound patients at the 22nd Annual Symposium on Advanced Wound Care and Wound Healing Society (SAWC/WHS) Meeting. These results were presented by well-regarded medical professionals who shared encouraging findings from their independent research. These types of presentations are excellent opportunities for us to have our product championed by key opinion leaders to groups of potential users.
Our recent 510(k) submission in orthopedic indications further enhances our existing AutoloGel System and streamlines the process to produce the gel, thereby making the clinical process more efficient. Upon clearance we look forward to bringing these advances to our growing customer base and to potential orthopedic partners who may be interested in licensing this advanced technology.
We are making further progress with our reimbursement initiatives, an area we recognize as being critical to the long-term and widespread adoption of our technology in wound healing. Toward that end we continue to build the body of clinical and scientific data to support a favorable determination from the Centers for Medicare and Medicaid Services (CMS). In the interim, we remain focused on the more than 70% of the market that is either provided in Long Term Acute Care facilities, is part of a capitated payment environment, is covered by private payers or is included in governmental programs such as the Veteran’s Health Administration.
We have initiated a strategy to penetrate these and other capitated programs, and have embarked on a program for patient pre-authorizations with various private insurers. We are encouraged by early responses to these initiatives.
Efforts to reform the U.S. healthcare system include calls for studies to provide comparative data on both the efficacy and the cost-effectiveness of various treatments. We believe that the AutoloGel System can benefit from such initiatives as pharmacoeconomic data published in the December 2008 edition of the peer-reviewed, multidisciplinary scientific journal Advances in Skin and Wound Care presented a cost-effectiveness analysis comparing the AutoloGel System to alternative technologies for managing non-healing diabetic foot ulcers. The author concluded that the use of the AutoloGel System may result in improved quality of life and lower cost of care over a five-year period versus other technologies for non-healing diabetic foot ulcers. These findings suggest that the AutoloGel System may be an attractive means for insurers and healthcare providers to address the cost burden and health effects of a variety of chronic wound conditions.
We continue to use data and publications such as these, along with our legislative, patient and clinician advocacy efforts, as the cornerstone of our strategic initiatives to garner support for favorable reimbursement.
Cytomedix’s long-range goal is to become a leading developer of advanced biological therapies to treat complex clinical problems. Toward that end, we continue to innovate and expand our product pipeline, which includes our lead development candidate CT-112. This compound is an octapeptide sequence derived from human platelet factor 4 (PF4 or CXCL4) that was identified through investigation of α chemokines that affect the movement of inflammatory cells into sites of tissue injury. Initial preclinical data support multiple routes of administration and multiple indications for such a powerful anti-inflammatory.
CT-112 was shown to be potentially useful as a therapeutic for a number of autoimmune diseases, such as rheumatoid arthritis, graft-versus-host disease, chronic obstructive pulmonary disease, reperfusion injury and atherosclerosis. Market assessments found that these fields are crowded with new therapies under investigation, and that the requisite clinical trials are lengthy and involve large numbers of patients .
As I reported in my last letter, we engaged the Frankel Group to conduct a review of potential therapeutic indications for CT-112, which revealed a number of underserved conditions that provide optimal market opportunity along with a well-defined regulatory pathway. These included Pyoderma gangrenosum (PG), coated stents and atopic dermatitis. Based on the findings of this review, our next steps will be to complete additional animal studies to provide proof-of-concept data in support of the utility of CT-112 in coated stents. This will provide us with the platform to engage in dialogue with a number of potential collaborators with an aim toward partnering or licensing CT-112 in this indication.
Once we have secured a partner, we plan to use the proceeds from such an agreement to further develop CT-112 in indications where we believe we can successfully advance the compound on our own. PG is a likely first target as it has potential for orphan status, which provides for extended patent protection and potential funding from FDA’s Office of Orphan Drugs, among other benefits.
The first half of 2009 got off to a strong start and the balance of the year continues to look promising. We substantially increased product sales and raised capital to build on the momentum of our renewed commercial strategy for the AutoloGel System in wound healing. We are optimistic about the near and intermediate term growth opportunities as Cytomedix continues to expand the clinical and scientific body of knowledge in support of the AutoloGel System as an efficacious and cost-effective therapeutic. We are equally enthusiastic about the longer term future for Cytomedix as our success will allow us to advance our pipeline of promising regenerative therapies for wound care, inflammation and angiogenesis.
I extend thanks to our talented and dedicated staff, whose commitment is the cornerstone to maintaining the quality of our products and a high level of innovation, and I thank you, our loyal shareholders, for your continued support and encouragement.
I look forward to keeping you apprised of our progress.
Martin P. Rosendale
Chief Executive Officer
Cytomedix is a biotechnology company that develops, sells, and licenses regenerative biological therapies, including 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. Additional information regarding Cytomedix is available at: http://www.cytomedix.com
SAFE HARBOR STATEMENT
Statements contained in this press release 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, the outcome of development or regulatory review of CT-112, commercial success or acceptance by the medical community, competitive responses, viability and effectiveness of the Company's sales approach and overall marketing strategies, 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.
David Jorden, Executive Board Member
Martin Rosendale, CEO
Lippert/Heilshorn & Associates
Anne Marie Fields