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Salaries and Wages
Salaries and wages rose $90,000 (22%) to $493,000 and $300,000 (33%) to $1,219,000 comparing the three and six months ended June 30, 2006, respectively, to the same periods last year.
For the three month period, the increase was primarily due to decreased non-cash equity-based compensation ($37,000) relating to the fair valuation of stock options and additional employees.
For the six month period, the increase was primarily due to increased non-cash equity-based compensation ($203,000) relating to the fair valuation of stock options and additional employees.
Consulting and Related Party Consulting Expenses
Consulting and related party consulting expenses fell $71,000 (60%) to $48,000 and $179,000 (66%) to $94,000 comparing the three and six months ended June 30, 2006, respectively, to the same periods last year.
For the three and six month periods, the decreases were primarily due to $50,000 and $92,000 decreases, respectively, in non-cash equity-based compensation and the overall reduction in the number of outside consultants.
Professional Fees
Professional fees fell $276,000 (69%) to $121,000 and $471,000 (69%) to $209,000 comparing the three and six months ended June 30, 2006, respectively, to the same periods last year. Professional fees consist primarily of legal and accounting services.
For the three and six month periods, the decreases were due to decreases in patent litigation related expenditures ($191,000 and $265,000 respectively) due to the successful completion of several patent infringement actions in 2005, as well as decreases in auditing/accounting fees ($38,000 and $78,000 respectively), and decreases in fees to securities and general counsel attorneys ($41,000 and $122,000 respectively) due primarily to reduced current period activity related to the Company’s listing on the American Stock Exchange.
Clinical Trial Related Expenses
Clinical trial related expenses fell $429,000 (99%) to $4,000 and $895,000 (94%) to $62,000 comparing the three and six months ended June 30, 2006, respectively, to the same periods last year. The Company completed the active phase of the trial in 2005 and in the first two quarters of 2006 incurred only expenses associated with the close out of the trial. The Company does not expect to incur significant future expenditures related to this trial unless additional patient enrollment is requested by the FDA under their review of the Company’s 510(k).
General and Administrative Expenses
General and administrative expenses fell $528,000 (63%) to $311,000 and $518,000 (43%) to $683,000 comparing the three and six months ended June 30, 2006, respectively, to the same periods last year.
For the three month period, the decrease was due primarily due to decreases in equity-based compensation to the board of directors and outside service providers ($322,000) and reduced travel related expenditures ($91,000).
For the six month period, the decrease was due primarily to decreases in equity-based compensation to the board of directors and outside service providers ($261,000), reduced travel related expenditures ($108,000), reduced AMEX filing fees ($55,000), and reduced personnel placement fees ($30,000).
Other Income/Expenses
Other income rose $837,000 (95%) to $1,717,000 and $1,068,000 (158%) to $1,745,000 comparing the three and six months ended June 30, 2006, respectively, to the same periods last year.
For the three month period, the increase in Other income was due to increased interest income as a result of higher interest rates and larger cash balances, and increased patent settlement income related to the Biomet settlement ($1,670,000, net).
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For the six month period, the increase in Other income was due to increased interest income as a result of higher interest rates, a one time charge ($228,000) in 2005 recorded for the issuance of 65,000 shares of the Company’s Common stock in return for a full settlement and release of all claims from a lawsuit brought against the Company relating to its emergence from bankruptcy, and increased patent settlement income related to the Biomet settlement ($1,670,000, net).
Liquidity and Capital Resources
The Company’s operating revenues do not cover the costs of its operations. The cash position of the Company at June 30, 2006 was $5,149,000. The Company believes that it will have adequate cash on hand to fund operations for the next twelve months. However, additional cash may be required if operating revenues do not materialize, the cost of operations increases, or the FDA requires the enrollment of additional patients to supplement the existing data from the clinical trial.
The Company has no material commitments for capital expenditures.
Because the Company was in bankruptcy in 2002, the Company may not be able to obtain debt financing. All working capital required to implement the Company’s business plan will be provided by funds obtained through offerings of its equity securities, and revenues generated by the Company.
Prospects for the Future
Cytomedix’s success is directly dependent on the success of AutoloGelTM, which the Company believes has a very good chance for success in the marketplace.
In capitated environments, which are not sensitive to direct reimbursement for AutoloGelTM (e.g., long-term care, long-term acute care, home healthcare), the weekly use of AutoloGelTM saves much of the labor costs associated with daily and multiple dressing changes, while at the same time increasing the rate of healing as compared to traditional treatments. The Company believes that data from its retrospective studies and current reports from clinicians, and a higher wound healing rate as compared to an enhanced control as evidenced in its recently completed clinical trial, prove greater efficacy than any competing treatment with FDA approval or clearance. The Company expects that both the facility/agency providing the care as well as the wound patient will realize direct benefits from the use of AutoloGelTM. Cytomedix is actively pursuing this market, primarily through its distributor, NWT. The Company may expand its distributor relationships to increase the chances of broad penetration into this market.
In addition, the Company is aggressively addressing the reimbursement market. The Company believes that in order to capture a significant share of this market, it must first obtain a CMS reimbursement code. Obtaining this code may be more likely if FDA clearance is obtained. The Company submitted a 510(k) for marketing clearance to the FDA in January 2006 and is in the process of responding to questions raised by the FDA during the ordinary 510(k) process. The Company cannot predict whether clearance will be granted, but Cytomedix does believe that the high levels of safety and effectiveness indicated by the data from the clinical trial more than meet the level of “reasonable assurance of safety and effectiveness” and demonstrates substantial equivalence to the predicate devices. Furthermore, the Company is completing a pharmaco-economic study which it believes will demonstrate superior clinical safety and efficacy of AutoloGelTM as well as the cost-effectiveness as compared to alternative treatments. However, even if FDA clearance is obtained, there is no guarantee the Company will receive a CMS reimbursement code. If CMS reimbursement is obtained, it is more likely that reimbursement may be obtained from the various commercial third-party insurers as well, which will help facilitate broad penetration into the reimbursement market. The Company refers the reader to a more detailed discussion regarding the clinical trials and reimbursement earlier in this section under the headingReimbursement and Clearance.
Cytomedix has completed its clinical trial which yielded favorable results and submitted a 510(k) Pre-market Notification for marketing clearance to the FDA. Obtainment of FDA clearance would allow the Company to broadly market its product for specific indications as well as enhance its chances of obtaining a national reimbursement code from CMS. Cytomedix believes it has a very strong patent position in the platelet gel arena. The Company remains optimistic that AutoloGelTM offers a patent protected treatment that is superior in several ways to most, if not all, of its competition and furthermore believes that it has achieved several critical milestones that bring it closer to broad commercialization of AutoloGelTM.
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Item 3. Quantitative and Qualitative Disclosures About Market Risk
The Company does not enter into financial instruments for speculation or trading purposes. In accordance with the Company’s investment policy, cash is to be invested in bank and institutional money market funds, or in T-Bills or short-term T-Notes. At June 30, 2006, the Company’s cash balance of approximately $5.1 million was maintained primarily in bank and institutional money market accounts. These accounts are sensitive to changes in the general level of interest rates. Based on the Company’s cash balances at June 30, 2006, a 100 basis point increase or decrease in interest rates would have an approximately $51,000 impact on the Company’s annual interest income and net loss. Actual changes in rates may differ from the hypothetical assumption used in computing this exposure.
Item 4. Controls and Procedures
The Company’s CEO and CFO have reviewed and evaluated the effectiveness of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Securities Exchange Act of 1934). Based on their evaluation, they have concluded that as of June 30, 2006, the Company’s disclosure controls and procedures are not effective to ensure that information required to be disclosed by Cytomedix in its reports filed with the SEC is recorded, processed, summarized, and reported within the governing time periods.
Cytomedix is subject to Section 404 of the Sarbanes Oxley Act (“SOX404”) for the year ending December 31, 2006. The Company has engaged an outside consultant to assist in its compliance with SOX404 and is in the process of making the necessary preparations.
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PART II
OTHER INFORMATION
Item 1. Legal Proceedings
At present, the Company is not engaged in or the subject of any legal proceedings.
Item 1A. Risk Factors
There were no material changes from the risk factors as previously disclosed on the Company’s Form 10-KSB filed with the Securities and Exchange Commission for the year ended December 31, 2005.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
The Company issued 1,616,399 shares of Common stock during the six months ended June 30, 2006. The following table lists the sources of and the proceeds from those issuances:
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Source | | # of Shares | | Proceeds |
Conversion of series A convertible preferred shares | | | 213 | | | $ | — | |
Exercise of class B warrants | | | 22,500 | | | | 33,750 | |
Exercise of series C-1 warrants | | | 542,500 | | | | 813,750 | |
Exercise of series C-2 warrants | | | 6,250 | | | | 9,375 | |
Exercise of unit offering warrants | | | 967,666 | | | | 1,451,500 | |
Exercise of options issued under the Long-Term Incentive Plan(1) | | | 54,200 | | | | 81,300 | |
Exercise of other warrants | | | 23,070 | | | | 23,070 | |
Totals | | | 1,616,399 | | | $ | 2,412,745 | |
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| (1) | The issuance of the shares under the Company’s Long-Term Incentive Plan were registered by the Company’s S-8 filed on November 1, 2004. |
The Company has used the cash proceeds from these issuances for general corporate purposes. All shares were issued in private offerings exempt from registration pursuant to Section 4(2) of the Securities Act, except as described in footnote 1 to the above table.
In May 2006, the Company paid a cash dividend on Series C Convertible Preferred shares at the rate of six percent per annum, amounting to $11,000. The dividends were calculated based on the number of days the shareholder held the Series C Convertible Preferred shares prior to conversion.
No dividends were declared or paid on the Company’s Common Stock in any of the periods discussed in this report. The Company does not anticipate paying cash dividends on its Common Stock in the foreseeable future, but instead will retain any earnings to fund growth. The Company is prohibited from declaring dividends on its Common Stock as long as any shares of Series A, B, or C convertible preferred stock are outstanding unless all accrued dividends on these classes of preferred stock have been paid. Once there are no shares of Series A, B, or C convertible preferred stock outstanding, any decision to pay cash dividends on the Common Stock will depend on the ability to generate earnings, the need for capital, the overall financial condition, and other factors the Board deems relevant.
Item 3. Defaults Upon Senior Securities
N/A
Item 4. Submission of Matters to a Vote of Security Holders
No matter was submitted to a vote of the security holders during the second quarter of 2006.
Item 5. Other Information
N/A
Item 6. Exhibits
The exhibits listed in the accompanying Exhibit Index are furnished as part of this report.
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SIGNATURES
Pursuant to the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
CYTOMEDIX, INC.
| By: | /s/ Kshitij Mohan
Kshitij Mohan, CEO and Chairman of the Board of Directors |
Date: November 14, 2007
In accordance with the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
| By: | /s/ Kshitij Mohan
Kshitij Mohan, CEO and Chairman of the Board of Directors |
Date: November 14, 2007
| By: | /s/ Andrew S. Maslan
Andrew S. Maslan, Chief Financial Officer and Chief Accounting Officer |
Date: November 14, 2007
Signed originals of this written statement have been provided to Cytomedix, Inc. and will be retained by Cytomedix, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.
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EXHIBIT INDEX
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Number | | Exhibit Table |
2.1 | | First Amended Plan of Reorganization with All Technical Amendments (Previously filed on June 28, 2002, on Form 8-K, File No. 000-28443). |
2.2 | | Amended and Restated Official Exhibits to the First Amended Plan of Reorganization of Cytomedix, Inc. with All Technical Amendments (Previously filed on May 10, 2004, on Form 10-QSB for the quarter ended March 31, 2004, File No. 000-28443). |
3.1 | | Restated Certificate of Incorporation of Cytomedix, Inc. (Previously filed on November 7, 2002, on Form 10-QSB for quarter ended June 30, 2001, File No. 000-28443). |
3.2 | | Amendment to Restated Certificate of Incorporation of Cytomedix, Inc. (Previously filed on November 15, 2004, on Form 10-QSB for quarter ended September 30, 2004, File No. 000-28443). |
3.3 | | Restated Bylaws of Cytomedix, Inc. (Previously filed on November 7, 2002, on Form 10-QSB for quarter ended June 30, 2001, File No. 000-28443). |
4.1 | | Amended and Restated Certificate of Designation of the Relative Rights and Preferences of Series A Preferred, Series B Preferred and common stock of Cytomedix, Inc. (Previously filed on March 31, 2004, on Form 10-KSB for year ended December 31, 2003, File No. 000-28443). |
4.2 | | Certificate of Designation of the Relative Rights and Preferences of the Series C Convertible Stock of Cytomedix, Inc. as filed with the Delaware Secretary of State on March 25, 2004 (Previously filed on March 29, 2004 on Form 8-K, File No. 000-28443). |
4.3 | | Form of Class B Warrant issued to New Investors and DIP Lenders (Previously filed on December 5, 2002, on Form 10-QSB for quarter ended September 30, 2001, File No. 000-28443). |
4.4 | | Form of Series C-1 Warrant to Purchase Shares of common stock of Cytomedix, Inc. (Previously filed on March 29, 2004 on Form 8-K, File No. 000-28443.) |
4.5 | | Form of Series C-2 Warrant to Purchase Shares of common stock of Cytomedix, Inc. (Previously filed on March 29, 2004 on Form 8-K, File No. 000-28443). |
4.7 | | Form of warrant issued to investors in the 2004 Unit Offering (Previously filed on May 11, 2004, on Form SB-2, File No. 333-115364). |
4.8 | | Form of D Warrant to Purchase Common Stock of Cytomedix, Inc. (Previously filed on May 2, 2006, on Form 8-K, File No. 001-32518). |
10.1 | | Royalty Agreement, dated as of December 26, 2000, by and between Cytomedix, Inc. and Curative Health Services, Inc. (Previously filed on January 17, 2001, on Form 8-K, File No. 000-28443). |
10.2 | | First Amendment to Royalty Agreement, dated as of April 20, 2001, by and between Cytomedix, Inc. and Curative Health Services, Inc. (Previously filed on May 25, 2001, on SB-2/A, File No. 333-55818). |
10.3 | | Second Amendment to Royalty Agreement, dated as of December 5, 2002, by and between Cytomedix, Inc. and Curative Health Services, Inc. (Previously filed on March 31, 2003, on Form 10-KSB for year ended December 31, 2002, File No. 000-28443). |
10.4 | | Cytomedix, Inc. Long-Term Incentive Plan (Previously filed on November 7, 2002, on Form 10-QSB for quarter ended June 30, 2001, File No. 000-28443). |
10.5 | | License Agreement dated March 21, 2001, by and between Cytomedix, Inc. and DePuy AcroMed, Inc. (Previously filed on April 16, 2001, on Form 10-KSB for year ended December 31, 2000, File No. 000-28443). |
10.6 | | Amendment dated March 3, 2005, to the License Agreement by and between Cytomedix, Inc. and DePuy Spine, Inc. (f/k/a DePuy Acromed, Inc.) (Previously filed on March 31, 2005, on Form 10-KSB for year ended December 31, 2004, File No. 000-28443). |
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Number | | Exhibit Table |
10.7 | | Second License Agreement dated March 3, 2005, to the License Agreement by and between Cytomedix, Inc. and DePuy Spine, Inc. (f/k/a DePuy Acromed, Inc.) (Previously filed on March 31, 2005, on Form 10-KSB for year ended December 31, 2004, File No. 000-28443). |
10.8 | | Settlement and License Agreement dated May 1, 2005 by and between Cytomedix, Inc. and Medtronic, Inc. (Previously filed on May 10, 2005, on Form 8-K, File No. 000-28443). |
10.9 | | Settlement Agreement and License Agreement dated May 23, 2005, by and between Cytomedix, Inc., and Harvest Technologies Corporation (Previously filed on May 27, 2005, on Form 8-K, File No. 000-28443). |
10.10 | | Settlement and License Agreement dated June 26, 2005, by and between Cytomedix, Inc., and Perfusion Partners and Associates Inc. (Previously filed on August 15, 2005, on Form 10-QSB for the quarter ended June 20, 2005, File No. 000-28443). |
10.11 | | License Agreement dated October 7, 2005, by and between Cytomedix, Inc., and COBE Cardiovascular, Inc. (Previously filed on October 11, 2005, on Form 8-K, File No. 000-28443). |
10.12 | | Settlement and License Agreement dated October 12, 2005, by and between Cytomedix, Inc., and SafeBlood Technologies, Inc. (Previously filed on November 9, 2005, on Form 10-QSB, File No. 000-28443). |
10.13 | | Employment Agreement with Ms. Carelyn P. Fylling (Previously filed on December 5, 2002, on Form 10-QSB for quarter ended September 30, 2001, File No. 000-28443). |
10.14 | | Employment Agreement with Kshitij Mohan, Ph.D., dated April 20, 2004 (Previously filed on May 7, 2004, on Form 8-K, File No. 00028443). |
10.15 | | Employment Agreement dated June 3, 2005, by and between Cytomedix, Inc., and Andrew Maslan (Previously filed on June 20, 2005, on Form 8-K, File no. 000-28443). |
10.16 | | Distributor Agreement dated October 31, 2005 by and between Cytomedix, Inc. and National Wound Therapies, LLC. (Previously filed on March 23, 2006, on Form 10-KSB, File No. 001-32518) |
10.17 | | Settlement and License Agreement dated May 19, 2006, by and between Cytomedix, Inc., and Biomet Biologics, Inc. |
20.1 | | Definitive Proxy Statement (Previously filed on September 16, 2005, File No. 000-28443). |
31.1 | | Certification of Chief Executive Officer of Cytomedix, Inc., pursuant to Rule 13a-14(a)/15d-14. |
31.2 | | Certification of Chief Financial Officer of Cytomedix, Inc., pursuant to Rule 13a-14(a)/15d-14. |
32.1 | | Certificate of Chief Executive Officer of Cytomedix, Inc., pursuant to 18 U.S.C.ss.1350. |
32.2 | | Certificate of Chief Financial Officer of Cytomedix, Inc., pursuant to 18 U.S.C.ss.1350. |
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