We are a development-stage company, have been unprofitable since our inception and expect to incur substantial additional operating losses for at least the foreseeable future as we incur expenditures on research and development, implement commercial operations and allocate significant and increasing resources to sales, marketing and other start-up activities. Accordingly, our activities to date are not as broad in depth or scope as the activities we may undertake in the future, and our historical operations and financial information are not necessarily indicative of the future operating results or financial condition or ability to operate profitably as a commercial enterprise.
We generate revenues by charging fees to licensed healthcare providers for access to our proprietary protocols for use in treating their patients, and for providing administrative management services in connection with such treatments. The administrative services offered by us include provision of an on-site liaison, education and training, patient registration, continuing care information, marketing and sales support, and data collection and aggregation.
From inception through June 30, 2004, we have recognized $147,000 in license fee revenues for a limited number of patients commencing in the third quarter 2003 who have been treated at Little Company of Mary–San Pedro Hospital in Los Angeles using the HANDS Treatment Protocol. In May 2004 we signed our second license agreement with Lake Chelan Community Hospital of Washington, which is not expected to begin treating patients until September 2004. As we implement commercial operations and allocate significant and increasing resources to business development, sales and marketing, we intend to enter into similar agreements with additional hospitals and licensed healthcare providers and increase the number of patients treated.
Our license agreements provide for a combined fee for the licensed technology and related services, set on a per patient basis, and thus our revenues are generally related to the number of patients treated. Key indicators of our financial performance in the future will be the number of facilities and healthcare providers that will contract with us to license our technology and the number of patients that are treated by those providers using the HANDS protocols.
Expenses
We have devoted a substantial portion of our resources to the payment of salaries and benefits, legal and professional and other general and administrative expenses during our start-up period. From February 13, 2003 (inception of Hythiam) to June 30, 2004, we have incurred $4.3 million in salaries and benefits and $4.6 million in other general and administrative costs, including $656,000 in stock-based expense. We did not have any business activity in the first quarter 2003, and only $201,000 in operating expenses were incurred in the three-month period ended June 30, 2003.
Salaries and benefits expenses were $1.4 million and $2.7 million for the three-month and six-month periods ended June 30, 2004, compared to $63,000 for the same three-month and six-month periods in 2003. Other general and administrative expenses were $1.0 million and $2.7 million for the three-month and six-month periods ended June 30, 2004, compared to $138,000 for the same three-month and six-month periods in 2003. Included in the three-month and six-month periods ended June 30, 2004, were non-cash (credits) charges of ($257,000) and $311,000, respectively, related to options, warrants and common stock issued to consultants and directors. The variance in stock-based expense was due primarily to a decrease in the market value of our stock from March 31, 2004, to June 30, 2004. Excluding non-cash charges (credits), other general and administrative expenses for the three-month and six-month periods ended June 30, 2004 were $1.2 million and $2.4 million, respectively, consisting primarily of legal, audit, insurance, rent, investor relations and other professional consulting costs. There were no significant variances in these expenses between the first and second quarters in 2004.
Liquidity and Capital Resources
We have financed our operations since inception primarily through the sale of shares of our stock. In September 2003 we received net proceeds of approximately $21 million from the private placement of equity securities. During 2003 and through June 30, 2004, we used approximately $7 million in operations and approximately $3 million in capital expenditures and acquisition of intellectual property, leaving a balance of approximately $11 million in cash, cash equivalents and marketable securities at June 30, 2004.
Since we are a developing business, our prior operating costs are not representative of our expected on-going costs. In the first quarter of 2004 we focused on completing the hiring of our senior management team and supporting staff, and in the second quarter we began to devote greater resources to marketing and business development. As we implement commercial operations and allocate significant and increasing resources to sales, marketing and other start-up activities, we expect our monthly cash operating expenditures in 2004 to increase to an average of approximately $1 million per month for the remainder of the year, excluding operating costs related to new treatment sites. In addition, we plan to spend up to approximately $1 million in the remainder of 2004 and approximately $2 million in 2005 to sponsor formal scientific studies for our HANDS protocols.
In the first six months of 2004, we expended approximately $300,000 to complete the build-out, furnishing and equipping of our new corporate offices. We plan to spend approximately $250,000 in additional capital expenditures in 2004 as we develop information systems, increase our staff and purchase equipment for new treatment sites opened by licensees. We continue to invest in the infrastructure we believe we will need, both in management as well as systems and equipment, to develop, market and implement our business plan.
Our future capital requirements will depend upon many factors, including progress with marketing our technologies, the time and costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims and other proprietary rights, the necessity of, and time and costs involved in obtaining, regulatory approvals, competing technological and market developments, and our ability to establish collaborative arrangements, effective commercialization, marketing activities and other arrangements. We expect to continue to incur negative cash flows and net losses for at least the next twelve months.
Based upon our current plans, we believe that our existing cash reserves will not be sufficient to meet our operating expenses and capital requirements before we achieve profitability. Accordingly, we intend to raise additional funds through public or private placement of shares of preferred or common stock or through public or private financing. Our ability to meet our cash obligations as they become due and payable will depend on our ability to sell securities, borrow funds, reduce operating costs or some combination thereof. We may not be successful in raising necessary funds on acceptable terms, or at all.
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Off-Balance Sheet Arrangements
As of June 30, 2004 we had no off-balance sheet arrangements.
Critical Accounting Policies and Estimates
The discussion and analysis of our financial condition and results of operations is based upon our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. Generally accepted accounting principles require management to make estimates, judgments and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and the disclosure of contingent assets and liabilities. We base our estimates on experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that may not be readily apparent from other sources. Our actual results may differ from those estimates. We consider our critical accounting policies to be those that involve significant uncertainties, require judgments or estimates that are more difficult for management to determine or that may produce materially different results when using different assumptions. We consider the following accounting policies to be critical:
Revenue recognition
Our revenues are derived from licensing our technology and providing administrative services to hospitals, treatment facilities and other healthcare providers. We recognize revenues as licensing fees are earned, the services are performed and collectibility is reasonably assured. Our licensing fees relate to the use of our proprietary treatment protocols for each patient completing treatment. Under the terms of our current contract, administrative services consists of education services (initial training in the use of the protocols) and data reports (principally pre-registration information, clinical screening data and patient satisfaction reports completed prior to or at the completion of treatment). The technology license, education services and data reports represent multiple service arrangements under the contract, as all of the fees for licensing and provision of services are included in one fee determined on a per patient basis. The per-patient fees have not been allocated to each of the multiple service elements, since substantially all of the licensing fees and other service elements are earned at the time of completion of patient treatment, and we recognize revenues only upon completion of patient treatment.
Stock-based expense
We account for the issuance of options and warrants for services from non-employees in accordance with SFAS 123, “Accounting for Stock-Based Compensation” by estimating the fair value of options and warrants issued using the Black-Scholes pricing model. This model’s calculations include the exercise price, the market price of shares on grant date, the weighted average information for risk-free interest, expected life of the option or warrant, expected volatility of the company’s stock and expected dividends. The amounts recorded in the financial statements for stock-based compensation expense could vary significantly if we were to use different assumptions.
Impairment of intangible assets
We have capitalized significant costs, and plan to capitalize additional costs, for acquiring patents and other intellectual property directly related to our products and services. We will need to evaluate our intangible assets for impairment on an ongoing basis by assessing the future recoverability of such capitalized costs based on estimates of our future revenues less estimated costs. Since we are a development stage company and have not recognized significant revenues to date, our estimates of future revenues may not be realized and the net realizable value of our capitalized costs of intellectual property may become impaired.
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Our accounting policies are more fully described in Note 2 to our audited financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2003.
Recent Accounting Pronouncements
In December 2003, the FASB revised FASB Interpretation No. 46, “Consolidation of Variable Interest Entities” (“FIN 46”), delaying the effective dates for certain entities and making other amendments to clarify application of the guidance. We have reviewed the provisions of FIN 46R and have determined that we have no variable interest entities; consequently, there was no impact on our financial statements.
ITEM 3. Quantitative and Qualitative Disclosures About Market Risk
There have been no material changes in market risks since the filing of our Annual Report on Form 10-K for the year ended December 31, 2003.
ITEM 4. Controls and Procedures
We have evaluated, under the supervision and with the participation of our Chief Executive Officer and our Chief Financial Officer, the effectiveness of our system of disclosure controls and procedures as of the end of the period covered by this report. Based on this evaluation our Chief Executive Officer and our Chief Financial Officer have determined that they are effective in connection with the preparation of this report. During the second quarter, our system of internal controls has evolved consistent with the development of the Company. There are no changes in our internal controls over financial reporting during the quarter ended June 30, 2004 that have materially effected, or are reasonably likely to materially effect, our internal controls over financial reporting.
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PART II - OTHER INFORMATION
ITEM 1. Legal Proceedings
From time to time, we may be involved in litigation relating to claims arising out of our operations in the normal course of business. As of the date of this prospectus, we are not currently involved in any legal proceeding that we believe would have a material adverse effect on our business, financial condition or operating results.
ITEM 2. Changes in Securities
In May 2004 we issued 360,000 shares in connection with the acquisition of certain intellectual property as described in Note 3 to our interim financial statements included in this Quarterly Report on Form 10-Q. Such shares have been pledged and are being held by us to secure the remaining obligations to us and may not be released or sold until such obligations are satisfied.
ITEM 3. Defaults upon Senior Securities
Not Applicable.
ITEM 4. Submission of Matters to a Vote of Security Holders
Our annual meeting of stockholders was held on June 18, 2004. Our stockholders elected all of the board’s nominees for director and also voted in favor of an amendment to increase by 1,000,000 the number of shares issuable under our 2003 Stock Incentive Plan.
(1) Election of Directors (each director received the same number of votes):
| For | 15,961,942 | |
| Withheld | 40,600 | |
(2) Amendment of 2003 Stock Incentive Plan:
| For | 15,188,147 | |
| Against | 99,548 | |
| Abstain | 96,800 | |
ITEM 5. Other Information
CAUTIONARY STATEMENT CONCERNING FORWARD-LOOKING INFORMATION
This report contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 with respect to the financial condition, results of operations, business strategies, operating efficiencies or synergies, competitive positions, growth opportunities for existing products, plans and objectives of management, markets for stock of Hythiam and other matters. Statements in this report that are not historical facts are hereby identified as “forward-looking statements” for the purpose of the safe harbor provided by Section 21E of the Exchange Act and Section 27A of the Securities Act. Such forward-looking statements, including, without limitation, those relating to the future business prospects, revenues and income of Hythiam, wherever they occur, are necessarily estimates reflecting the best judgment of the senior management of Hythiam on the date on which they were made, or if no date is stated, as of the date of this report. These forward-looking statements are subject to risks, uncertainties and assumptions, including those described in the “Risk Factors” in Item 1 of Part I of our most recent Annual Report on Form 10-K filed with the SEC and our Registration Statement on Form S-1 filed with the SEC on June 23, 2004, that may affect the operations, performance, development and results of our business. Because the factors discussed in this report could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements made by us or on our behalf, you should not place undue reliance on any such forward-looking statements. New factors emerge from time to time, and it is not possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.
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You should understand that the following important factors, in addition to those discussed above and in the “Risk Factors” could affect our future results and could cause those results to differ materially from those expressed in such forward-looking statements:
| • | general economic conditions, |
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| • | the effectiveness of our protocols, advertising, marketing and promotional campaigns, |
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| • | healthcare provider and patient acceptance of our products and services, including newly introduced products, |
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| • | competition among addiction treatment centers, |
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| • | anticipated trends and conditions in the industry in which we operate, including regulatory changes, |
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| • | development of new treatment modalities, |
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| • | our future capital needs and our ability to obtain financing, and |
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| • | other risks and uncertainties as may be detailed from time to time in our public announcements and filings with the SEC. |
We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or any other reason. All subsequent forward-looking statements attributable to the Company or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. In light of these risks, uncertainties and assumptions, the forward-looking events discussed in this report may not occur.
ITEM 6.Exhibits and Reports on Form 8-K
(a) Exhibits
| Exhibit 31.1 | Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
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| Exhibit 31.2 | Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
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| Exhibit 32.1 | Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
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| Exhibit 32.2 | Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
(b) Reports on Form 8-K
Current Report on Form 8-K, filed with the SEC on May 11, 2004 (reporting under Item 9)
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SIGNATURES
Pursuant to the requirements of 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.
| | | HYTHIAM, INC. | |
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Date: | August 9, 2004 | By: | /S/ TERREN S. PEIZER | |
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| | | | Terren S. Peizer | |
| | | | President and Chief Executive Officer | |
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Date: | August 9, 2004 | By: | /S/ CHUCK TIMPE | |
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| | | | Chuck Timpe | |
| | | | Chief Financial Officer | |
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