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 nine month periods ending September 30, 2007 and September 30, 2006. For the year ending December 31, 2007, we do not expect to have any revenues.
For the three month period ended September 30, 2007, research and development costs increased by $158,493, or 47.7% to $490,788 from $332,295 in the three month period ended September 30, 2006. The increase is primarily attributable to the in licensing costs of the Suponex (pexiganan acetate) product of $314,284, offset in part by a decrease in spending on the EcoNail clinical trial of $143,591 in the three month period ended September 30, 2007 compared with the same period in 2006. There was also a decrease in general research and development costs of approximately $12,200 for the three months ended September 30, 2007.
For the nine month period ended September 30, 2007, research and development costs increased by $558,667, or 114.4%, to $1,047,187 from $488,520 in the nine month period ended September 30, 2006. The increase is primarily attributable to the increase in spending on the EcoNail clinical trial of $173,391 in the nine month period ended September 30, 2007 compared with the same period in 2006, as well as an increase in general research and development consulting costs of approximately $71,000, in addition to costs of $314,284 associated with the in licensing of Suponex (pexiganan acetate). We expect research and development spending to increase for the last quarter from the level seen in the first three quarters of 2007 as we continue the clinical trial for EcoNail and formulation development of Suponex (pexiganan acetate).
For the three month period ended September 30, 2007, marketing, general and administrative costs increased by $23,453, or 2.8% to $851,925 from $828,472 in the three month period ended September 30, 2006. The increase is attributable to increases in legal, audit and patent related costs of $87,335, investor relations of $56,636 and an increase in stock based compensation of $19,333. The increase was partially offset by decreases in salary and related expenses of $32,640, insurance of $10,284, travel and conferences of $39,304, and rent and other office related expenses of $38,888.
For the nine month period ended September 30, 2007, marketing, general and administrative costs decreased by $191,972, or 6.5%, to $2,754,187, from $2,946,159 in the nine month period ended September 30, 2006. The decrease is primarily attributable to the expensing of stock options granted to employees based on the fair value on the date of the grant. The amount expensed for the nine month period ended September 30, 2007 was $456,482 compared to $804,489 for the nine month period ended September 30, 2006, resulting in a decrease in the expense of $348,007. There was also a decrease in salary and related expenses of $54,523, shareholder related expenses of $99,860, travel and conferences of $62,719, office related expenses of $19,806 and insurance costs of $29,150. The decrease was partially offset by increases in legal, audit and patent related costs of $229,088 and consulting and investor relations expenses of $205,061. For the last quarter of 2007, we expect the marketing, general and administrative spending to approximate the same level as seen in the first three quarters of 2007.
Other income and expense decreased by $1,243,012 to a gain of $602,918 in the three month period ended September 30, 2007 from a gain of $1,845,930 in the three month period ended September 30, 2006. The decrease is primarily attributable to a decrease in the gain associated with the change in value of the warrant liability of $1,179,528 for the three month period ended September 30, 2007. Interest income also decreased by $63,484, or 90.8% to $6,445 in the three month period ended September 30, 2007 from $69,929 in the three month period ended September 30, 2006. The decrease in interest expense is due to less cash available for investing purposes during the three month period ended September 30, 2007.
Other income and expense decreased by $7,733,310 to a loss of $1,066,806 in the nine month period ended September 30, 2007 from a gain of $6,538,914 in the nine month period ended September 30, 2006. The decrease is primarily attributable to an increase in the loss associated with the change in value of warrant liability of $7,544,229. Interest income also decreased by $129,491, or 68.5%, to $59,590 in the nine month period ended September 30, 2007 from $189,081 in the nine month period ended September 30, 2006. The decrease in
23
interest income is due to less cash available for investing purposes during the nine month period ended September 30, 2007.
For the reasons described above, the Company’s financial statements reflect a net loss of $739,795 in the three month period ended September 30, 2007 compared with a net gain of $685,163 in the three month period ended September 30, 2006. For the nine month period ended September 30, 2007, the Company’s financial statements reflect a net loss of $4,868,180 compared to a net gain of $3,104,235 in the nine month period ended September 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 nine 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 nine months of 2006, we received gross proceeds of $5,755,000 ($5,186,908 net of cash issuance costs) 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 September 30, 2007, working capital was approximately $1.6 million, compared to $5.5 million at September 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 nine month period ended September 30, 2007, we did not repurchase any shares of common stock. At September 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 nine month periods ended September 30, 2007. Capital expenditures and patent development costs were $40,770 for the nine month period ended September 30, 2006. We anticipate additional capital and patent expenditures will be approximately $25,000 for the remainder of the fiscal year ending December 31, 2007.
As of September 30, 2007, we had $1,762,960 in cash, cash equivalents and short-term investments. We believe that our existing cash, cash equivalents and short-term investments, plus the funds raised on October 10, 2007 will be sufficient to meet our current operating expenses and capital expenditure requirements through the first quarter of 2008. On October 10, 2007 the Company closed a private placement with gross proceeds of $3,535,000. See Footnote 8 – Subsequent Events to the Financial Statements. 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
24
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 September 30, 2007, the Company had no long term commitments. On October 5, 2007 the Company entered into a one year lease for office facilities commencing on February 1, 2008 and expiring on January 31, 2009, for a total commitment of $118,503.
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 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.
25
Item 3. Quantitative and Qualitative Disclosures about Market Risk
Cash, Cash Equivalents and Short-Term Investments
As of September 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 nine months ending September 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 September 30, 2007 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
26
PART II – OTHER INFORMATION
Except as set forth below, 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.
Federal regulatory reforms may create additional burdens that would cause us to incur additional costs and may adversely affect our ability to commercialize our products.
From time to time, legislation is drafted, introduced and passed in Congress that could significantly change the statutory provisions governing the approval, manufacturing and marketing of products regulated by the FDA. For example, on September 27, 2007, the Food and Drug Administration Amendments Act of 2007 (the “FDAAA”) was enacted, giving the FDA enhanced post-market authority, including the authority to require post-market studies and clinical trials, labeling changes based on new safety information, and compliance with a risk evaluation and mitigation strategy approved by the FDA. The FDA’s post-market authority takes effect 180 days after the enactment of the law. Failure to comply with any requirements under the FDAAA may result in significant penalties. The FDAAA also authorizes significant civil money penalties for the dissemination of false or misleading direct-to-consumer advertisements and allows the FDA to require companies to submit direct-to-consumer television drug advertisements for FDA review prior to public dissemination. Additionally, the new law expands the clinical trial registry so that sponsors of all clinical trials, except for Phase I trials, are required to submit certain clinical trial information for inclusion in the clinical trial registry data bank. In addition to the FDAAA, FDA regulations and guidance are often revised or reinterpreted by the agency in ways that may significantly affect our business and our products. It is impossible to predict whether further legislative changes will be enacted, or FDA regulations, guidance or interpretations will change, and what the impact of such changes, if any, may be.
27
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. |
28
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) |
November 13, 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) |
29
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. |
30