Our discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses. Note 1 to our financial statements included within our Annual Report on Form 10-K for the year ended December 31, 2006, includes a summary of the significant accounting policies and methods we use in the preparation of our financial statements. The following is a brief discussion of the more significant accounting policies and methods that affect the judgments and estimates used in the preparation of our financial statements.
We had no revenues for the three and six month periods ending June 30, 2007 and June 30, 2006. For the year ending December 31, 2007, we do not expect to have any revenues.
For the three month period ended June 30, 2007, research and development costs increased by $167,706, or 185.8% to $257,949 from $90,243 in the three month period ended June 30, 2006. The increase is primarily attributable to the increase in spending on the clinical trial of $153,450 in the three month period ended June 30, 2007 compared with the same period in 2006. There was also an increase in general research and development costs of approximately $20,000 for the three months ended June 30, 2007.
For the six month period ended June 30, 2007, research and development costs increased by $400,173, or 256.2%, to $556,398 from $156,225 in the six month period ended June 30, 2006. The increase is primarily attributable to the increase in spending on the clinical trial of $316,982 in the six month period ended June 30, 2007 compared with the same period in 2006 as well as an increase in general research and development consulting costs of approximately $85,000. For each of the next two quarters, we expect research and development spending to increase from the level seen in the first two quarters of 2007 as we continue the clinical trial for EcoNail.
For the three month period ended June 30, 2007, marketing, general and administrative costs decreased by $78,607, or 8.0% to $897,953 from $976,560 in the three month period ended June 30, 2006. The decrease is attributable to a decrease in salary and related expenses of $90,862, insurance expense of $12,293, conferences and travel of $44,594 and a decrease in stock based compensation of $65,827 for the three month period ended June 30, 2007. The decrease was partially offset by an increase in legal, audit and patent related costs of $100,945 and consulting and investor relations expense of $31,155.
For the six month period ended June 30, 2007, marketing, general and administrative costs decreased by $215,423, or 10.2%, to $1,902,264, from $2,117,687 in the six month period ended June 30, 2006. The decrease is primarily attributable to the Company’s adoption of SFAS No. 123R on January 1, 2006, which requires the expensing of stock options granted to employees based on the fair value on the date of the grant. The amount expensed for the six month period ended June 30, 2007 was $307,255 compared to $674,597 for the six month period ended June 30, 2006, resulting in a decrease in the expense of $367,342. The decrease was partially offset by an increase in salary and related expenses of $20,882 during the six month period ended June 30, 2007. In addition, in the six month period ended June 30, 2007, legal, audit and patent expenses increased by approximately $140,927, and consulting and investor relations expenses increased by $60,103. For each of the next two quarters, we expect marketing, general and administrative spending to approximate the same level as seen in the first two quarters of 2007.
Other income and expense decreased by $6,921,626 to a loss of $1,444,391 in the three month period ended June 30, 2007 from a gain of $5,477,235 in the three month period ended June 30, 2006. The decrease is primarily attributable to an increase in the loss associated with the change in value of the warrant liability of $1,515,006 for the three month period ended June 30, 2007. Interest income also decreased by $54,795, or 74.6% to $18,615 in the three month period ended June 30, 2007 from $73,410 in the three month period ended June 30, 2006. The decrease in interest expense is due to less cash available for investing purposes during the three month period ended June 30, 2007.
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Other income and expense decreased by $6,362,708 to a loss of $1,669,724 in the six month period ended June 30, 2007 from a gain of $4,692,984 in the six month period ended June 30, 2006. The decrease is primarily attributable to an increase in the loss associated with the change in value of warrant liability of $1,790,869. Interest income also decreased by $66,007, or 55.4%, to $53,145 in the six month period ended June 30, 2007 from $119,152 in the six month period ended June 30, 2006. The decrease in interest income is due to less cash available for investing purposes during the six month period ended June 30, 2007.
For the reasons described above, the Company’s financial statements reflect a net loss of $2,600,293 in the three month period ended June 30, 2007 compared with a net gain of $4,410,432 in the three month period ended June 30, 2006. For the six month period ended June 30, 2007, the Company’s financial statements reflect a net loss of $4,128,386 compared to a net gain of $2,419,072 in the six month period ended June 30, 2006.
Liquidity and Capital Resources
Since inception, our primary source of funding for our operations has been the private and public sale of our securities, and, to a lesser extent, the licensing of our proprietary technology and products, research collaborations, feasibility studies, government grants and the limited sales of products and test materials. During the first six months of 2007, we did not receive any proceeds from the exercise of options or warrants or from the sale of our securities. During the first six months of 2006, we received gross proceeds of $5,755,000 ($5,186,908 net of proceeds) as a result of the sale of our Series C Cumulative Convertible Preferred Stock in a private placement financing transaction, but no proceeds from the exercise of options and warrants.
At June 30, 2007, working capital was approximately $2,783,000, compared to $6,500,000 at June 30, 2006. The decrease in our working capital reflects use of funds in operations. Until such time as we obtain agreements with third-party licensees or partners to provide funding for our anticipated business activities, or otherwise generate revenue from the commercialization of our products, we will use our working capital to fund our operating activities.
Pursuant to a plan approved by our Board of Directors in 1998, we are authorized to repurchase 23,809 shares of our common stock to be held as treasury shares for future use. During the six month period ended June 30, 2007, we did not repurchase any shares of common stock. At June 30, 2007, 529 repurchased shares remain available for future use and 16,180 shares remain available for repurchase under the plan.
The Company had no capital expenditures or patent development costs for the three and six month periods ended June 30, 2007. Capital expenditures and patent development costs were $21,256 and $36,169 for the three and six month periods ended June 30, 2006, respectively. We anticipate additional capital and patent expenditures will be approximately $50,000 for the remainder of the fiscal year ending December 31, 2007.
As of June 30, 2007, we had $2,869,826 in cash, cash equivalents and short-term investments. We believe that our existing cash, cash equivalents and short-term investments will
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be sufficient to meet our current operating expenses and capital expenditure requirements into the first quarter of 2008. As described in Note 8 to the Financial Statements, the Company has entered into a 90-day exclusive option to license pexiganan, a novel, topical treatment for diabetic foot infections. If this option is exercised, the Company will require significant additional capital to proceed with the development of this new product. The Company’s continuation as a going concern depends on its ability to obtain additional financing, to consummate a strategic transaction or to make alternative arrangements to fund its operations There can be no assurance that the Company will be able to obtain additional financing, to consummate a strategic transaction, or to make alternative arrangements to fund its operations. Our cash requirements may vary materially from those now planned because of changes in the focus and direction of our research and development programs, identification of additional product candidates and technologies, competitive and technical advances, patent developments or other developments related to the status of fund raising. We will require additional financing to continue operations after we exhaust our current capital resources and to continue our long-term plans for clinical trials and new product development. We expect to continue financing our operations through sales of our securities, strategic alliances or other financing vehicles, if any, that might become available to us on terms that we deem acceptable.
We do not enter into financial instrument transactions for trading or speculative purposes. We do not intend to establish any special purpose entity and do not have any material off balance sheet financing transactions. We do not believe that inflation will have any significant effect on the results of our operations.
At June 30, 2007, the Company had no long-term contractual obligations.
Recent Accounting Pronouncements
In June of 2006, the FASB issued Financial Interpretation (“FIN”) 48, “Accounting for Uncertainty in Income Taxes - an interpretation of FASB Statement No. 109” (“FIN 48”). FIN 48 clarifies the accounting for uncertainty in income taxes recognized in the financial statements in accordance with SFAS 109, “Accounting for Income Taxes”. The interpretation was effective for fiscal years beginning after December 15, 2006. The adoption of this new standard did not have a material impact on our financial position, results of operations or cash flows.
On September 15, 2006, the FASB issued SFAS Statement No. 157, “Fair Value Measurements” (“SFAS 157”). This statement provides enhanced guidance for using fair value to measure assets and liabilities. This statement also responds to investors’ requests for expanded information about the extent to which companies measure assets and liabilities at fair value, the information used to measure fair value and the effect of fair value measurements on earnings. SFAS 157 applies whenever other standards require (or permit) assets or liabilities to be measured at fair value. SFAS 157 does not expand the use of fair value in any new circumstances. This statement is effective for financial statements issued for fiscal years beginning after November 15, 2007. We do not expect our adoption of this new standard to have a material impact on our financial position, results of operations or cash flows.
In February of 2007, the FASB issued SFAS Statement No. 159, “The Fair Value Option for Financial Assets and Financial Liabilities” (“SFAS 159”). SFAS 159 permits entities to
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choose to measure many financial assets and financial liabilities at fair value. Unrealized gains and losses on items for which the fair value option has been elected are reported in earnings. SFAS 159 is effective for fiscal years beginning after November 15, 2007. We are currently assessing the impact of SFAS 159 on our financial results.
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Item 3. Quantitative and Qualitative Disclosures about Market Risk
Cash, Cash Equivalents and Short-Term Investments
As of June 30, 2007, we were exposed to market risks, which relate primarily to changes in U.S. interest rates. Our cash equivalents and short-term investments are subject to interest rate risk and will decline in value if interest rates increase. Due to the short duration of these financial instruments, generally one year or less, changes in interest rates would not have a material effect on our financial position. A hypothetical 10% change in interest rates would not have a material effect on our Statement of Operations or Cash Flows for the six months ending June 30, 2007.
Item 4. Controls and Procedures
As of the end of the period covered by this report, we carried out a review, under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of our disclosure controls and procedures (as defined in the SEC rules promulgated under the Securities Exchange Act of 1934, as amended), which are designed to ensure that information required to be disclosed in our Securities and Exchange Commission reports is properly and timely recorded, processed, summarized and reported. Based upon that review, our Chief Executive Officer and Chief Financial Officer concluded that while our disclosure controls and procedures are effective in timely alerting them to material information required to be included in our periodic filings with the Securities and Exchange Commission, there is a lack of segregation of duties at the Company due to the small number of employees dealing with general administrative and financial matters. This constitutes a significant deficiency in financial reporting. However, at this time management has decided that, considering the employees involved and the control procedures in place, the risks associated with such lack of segregation are insignificant, and the potential benefits of adding additional employees to clearly segregate duties do not justify the expenses associated with such increases. Management will continue to evaluate this segregation of duties.
There were no changes in our internal control over financial reporting that occurred during the quarter ended June 30, 2007 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II – OTHER INFORMATION
There have been no material changes to the risk factors included in Item 1A of Part I of our annual Report on Form 10-K for the year ended December 31, 2006.
Item 4. Submission of Matters to a Vote of Security Holders
The Company’s Annual Meeting of Stockholders was held on May 10, 2007. At the meeting (i) all seven director nominees were elected, (ii) the appointment of Vitale, Caturano & Company, Ltd. as the Company’s independent registered public accounting firm was ratified, and (iii) amendments to the Company’s 2001 Incentive Plan to increase the number of shares of Common Stock authorized for issuance under the Incentive Plan by 1,000,000, were approved.
(i) The following directors were elected for one year terms by the votes indicated: Robert J. DeLuccia, 5,235,555 for, 20,908 against or withheld; John L. Zabriskie, 5,234,887 for, 21,576 against or withheld; Peter G. Martin, 5,235,573 for, 20,890 against or withheld; Jeffrey B. Davis, 5,234,696 for, 21,767 against or withheld; Michael A. Davis, 5,234,691 for, 21,772 against or withheld; Paul S. Echenberg, 5,235,542 for, 20,921 against or withheld; and Mark J. Alvino, 5,235,469 for, 20,994 against or withheld.
(ii) The appointment of Vitale, Caturano & Company, Ltd. was ratified by a vote of 5,239,101 for, 15,336 against and 2,026 abstaining.
(iii) Amendments to the Company’s 2001 Incentive Plan to increase the number of shares of Common Stock authorized for issuance under the Incentive Plan by 1,000,000 were approved by vote of 3,563,622 for, 95,174 against, 706 abstaining and 1,596,961 broker non-votes.
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The following is a list of exhibits to this Quarterly Report on Form 10-Q:
| |
3.1 | Amended and Restated Certificate of Incorporation, incorporated by reference to Exhibit 3.1 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2005 (File No. 0-13634). |
| |
3.2 | Amended and Restated By-Laws of the Company, incorporated by reference to Exhibit 5 to the Company’s Current Report on Form 8-K dated August 13, 1999 (File No. 0-13634). |
| |
31.1 | Certification of Principal Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
| |
31.2 | Certification of Principal Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
| |
32.1 | Certification of Principal Executive Officer Pursuant to Section 1350, Chapter 63 of Title 18, United States Code, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
| |
32.2 | Certification of Principal Financial Officer Pursuant to Section 1350, Chapter 63 of Title 18, United States Code, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| MacroChem Corporation |
| (Registrant) |
August 14, 2007 | /s/ Robert J. DeLuccia |
| Robert J. DeLuccia President and Chief Executive Officer (Principal Executive Officer) |
| /s/ Bernard R. Patriacca |
| Bernard R. Patriacca Vice President, Chief Financial Officer and Treasurer (Principal Financial Officer) |
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EXHIBIT INDEX
The following is a list of exhibits to this Quarterly Report on Form 10-Q:
3.1 | Amended and Restated Certificate of Incorporation, incorporated by reference to Exhibit 3.1 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2005 (File No. 0-13634). |
3.2 | Amended and Restated By-Laws of the Company, incorporated by reference to Exhibit 5 to the Company’s Current Report on Form 8-K dated August 13, 1999 (File No. 0-13634). |
31.1 | Certification of Principal Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
31.2 | Certification of Principal Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
32.1 | Certification of Principal Executive Officer Pursuant to Section 1350, Chapter 63 of Title 18, United States Code, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
32.2 | Certification of Principal Financial Officer Pursuant to Section 1350, Chapter 63 of Title 18, United States Code, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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