Ontrak, Inc. - Quarter Report: 2005 June (Form 10-Q)
Table of Contents
United States
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
OF THE SECURITIES EXCHANGE ACT OF 1934
For The Quarterly Period Ended June 30, 2005
Commission File Number 001-31932
HYTHIAM, INC.
(Exact name of registrant as specified in its charter)
Delaware | 88-0464853 | |
(State or other jurisdiction of incorporation) | (I.R.S. Employer Identification Number) |
11150 Santa Monica Boulevard, Suite 1500, California 90025
(Address of principal executive offices, including zip code)
(Address of principal executive offices, including zip code)
(310) 444-4300
(Registrants telephone number, including area code)
(Registrants telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes þ No o
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of
the Exchange Act).
Yes o No þ
As of August 4, 2005, there were 30,188,637 shares of registrants common stock, $0.0001 par value,
outstanding.
INDEX
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10 | ||||||||
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14 | ||||||||
II-1 | ||||||||
II-1 | ||||||||
II-1 | ||||||||
II-1 | ||||||||
II-2 | ||||||||
II-2 | ||||||||
II-3 | ||||||||
Exhibit 31.1 | ||||||||
Exhibit 31.2 | ||||||||
Exhibit 32.1 | ||||||||
Exhibit 32.2 |
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ITEM 1. Financial Statements
HYTHIAM, INC. AND SUBSIDIARIES
(a Development Stage Company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(a Development Stage Company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(Dollars in thousands, except share data)
June 30, | December 31, | |||||||
2005 | 2004 | |||||||
ASSETS |
||||||||
Current assets |
||||||||
Cash and cash equivalents |
$ | 1,806 | $ | 4,000 | ||||
Marketable securities |
18,179 | 23,479 | ||||||
Receivables, net |
129 | 168 | ||||||
Prepaids and other current assets |
656 | 446 | ||||||
Total current assets |
20,770 | 28,093 | ||||||
Long-term assets |
||||||||
Property and equipment, net |
2,502 | 2,424 | ||||||
Intellectual property, net |
3,105 | 3,080 | ||||||
Deposits and other assets |
556 | 365 | ||||||
$ | 26,933 | $ | 33,962 | |||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities |
||||||||
Accounts payable |
$ | 1,493 | $ | 609 | ||||
Accrued compensation and benefits |
768 | 826 | ||||||
Other accrued liabilities |
174 | 329 | ||||||
Total current liabilities |
2,435 | 1,764 | ||||||
Long-term liabilities |
||||||||
Deferred rent liability |
410 | 364 | ||||||
Commitments and contingencies |
||||||||
Stockholders equity |
||||||||
Preferred stock, $.0001 par value; 50,000,000 shares authorized; no shares
issued and outstanding |
| | ||||||
Common stock, $.0001 par value; 200,000,000 shares authorized;
30,177,000 and 30,111,000 shares issued and 29,817,000
and 29,751,000 shares outstanding at June 30, 2005 and
December 31, 2004, respectively |
3 | 3 | ||||||
Additional paid-in-capital |
48,499 | 47,234 | ||||||
Deficit accumulated during the development stage |
(24,414 | ) | (15,403 | ) | ||||
24,088 | 31,834 | |||||||
$ | 26,933 | $ | 33,962 | |||||
See accompanying notes to financial statements.
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HYTHIAM, INC. AND SUBSIDIARIES
(a Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(a Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Period from | ||||||||||||||||||||
February 13, | ||||||||||||||||||||
Three Months Ended | Six Months Ended | 2003 | ||||||||||||||||||
June 30, | June 30, | (Inception) to | ||||||||||||||||||
(In thousands, except per share amounts) | 2005 | 2004 | 2005 | 2004 | June 30, 2005 | |||||||||||||||
Revenues |
$ | 230 | $ | 5 | $ | 433 | $ | 72 | $ | 700 | ||||||||||
Operating Expenses |
||||||||||||||||||||
Salaries and benefits |
2,253 | 1,413 | 3,871 | 2,686 | 10,605 | |||||||||||||||
Other operating expenses |
2,635 | 980 | 5,504 | 2,681 | 13,782 | |||||||||||||||
Depreciation and amortization |
208 | 154 | 404 | 297 | 1,149 | |||||||||||||||
Total operating expenses |
5,096 | 2,547 | 9,779 | 5,664 | 25,536 | |||||||||||||||
Loss from operations |
(4,866 | ) | (2,542 | ) | (9,346 | ) | (5,592 | ) | (24,836 | ) | ||||||||||
Interest income |
174 | 37 | 335 | 77 | 547 | |||||||||||||||
Loss before provision for income taxes |
(4,692 | ) | (2,505 | ) | (9,011 | ) | (5,515 | ) | (24,289 | ) | ||||||||||
Provision for income taxes |
| | | 2 | 1 | |||||||||||||||
Net loss |
$ | (4,692 | ) | $ | (2,505 | ) | $ | (9,011 | ) | $ | (5,517 | ) | $ | (24,290 | ) | |||||
Basic and diluted net loss per share |
$ | (0.16 | ) | $ | (0.10 | ) | $ | (0.30 | ) | $ | (0.22 | ) | ||||||||
See accompanying notes to financial statements.
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Hythiam, Inc. and Subsidiaries
(a Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(a Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
Period from | ||||||||||||
February 13, | ||||||||||||
Six Months Ended | 2003 | |||||||||||
June 30, | (Inception) to | |||||||||||
(In thousands) | 2005 | 2004 | June 30, 2005 | |||||||||
Operating activities |
||||||||||||
Net loss |
$ | (9,011 | ) | $ | (5,517 | ) | $ | (24,290 | ) | |||
Adjustments to reconcile net loss to net cash used in operating
activities: |
||||||||||||
Depreciation and amortization |
404 | 297 | 1,149 | |||||||||
Provision for bad debt |
10 | | 10 | |||||||||
Deferred rent liability amortization |
11 | 14 | 58 | |||||||||
Share-based expense |
1,293 | 311 | 2,810 | |||||||||
Changes in current assets and liabilities: |
||||||||||||
Receivables |
63 | 121 | (105 | ) | ||||||||
Prepaids and other current assets |
(380 | ) | (53 | ) | (628 | ) | ||||||
Accounts payable |
746 | (622 | ) | 1,355 | ||||||||
Accrued compensation and benefits |
(58 | ) | 433 | 768 | ||||||||
Other accrued liabilities |
(155 | ) | (193 | ) | 174 | |||||||
Net cash used in operating activities |
(7,077 | ) | (5,209 | ) | (18,699 | ) | ||||||
Investing activities |
||||||||||||
Purchases of marketable securities |
(6,600 | ) | (7,573 | ) | (56,754 | ) | ||||||
Proceeds from sales and maturities of marketable securities |
11,900 | 10,000 | 38,575 | |||||||||
Purchases of property and equipment |
(275 | ) | (296 | ) | (3,224 | ) | ||||||
Deposits made on property and equipment |
(111 | ) | | (111 | ) | |||||||
Reimbursement of tenant improvement costs |
| | 301 | |||||||||
Proceeds from maturity of deposit as collateral for letter of credit |
| | 352 | |||||||||
Cash deposited as collateral for letter of credit |
(92 | ) | | (792 | ) | |||||||
Cost of intellectual property |
(82 | ) | 8 | (746 | ) | |||||||
Net cash provided by (used in) investing activities |
4,740 | 2,139 | (22,399 | ) | ||||||||
Financing activities |
||||||||||||
Net proceeds from sales of common and preferred stock and warrants |
| | 42,694 | |||||||||
Proceeds from exercise of warrants |
143 | | 210 | |||||||||
Net cash provided by financing activities |
143 | | 42,904 | |||||||||
Net (decrease) increase in cash and cash equivalents |
(2,194 | ) | (3,070 | ) | 1,806 | |||||||
Cash and cash equivalents at beginning of period |
4,000 | 3,444 | | |||||||||
Cash and cash equivalents at end of period |
$ | 1,806 | $ | 374 | $ | 1,806 | ||||||
Supplemental disclosure of cash paid |
||||||||||||
Income taxes |
$ | | $ | | $ | 3 | ||||||
Supplemental disclosure of non-cash activity |
||||||||||||
Common stock and warrants issued for intellectual property |
$ | | $ | | $ | 2,635 | ||||||
Common stock, options and warrants issued for outside services |
1,122 | 65 | 2,612 | |||||||||
Common stock and warrants issued as commissions on private placement |
| | 265 |
See accompanying notes to financial statements.
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Hythiam, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
Notes to Condensed Consolidated Financial Statements
Note 1. Basis of Presentation
The accompanying unaudited interim condensed consolidated financial statements for Hythiam,
Inc. and its subsidiaries have been prepared in accordance with the Securities and Exchange
Commission (SEC) rules for interim financial information and do not include all information and
notes required for complete financial statements. In the opinion of management, all adjustments,
consisting of normal recurring accruals, considered necessary for a fair presentation have been
included. Interim results are not necessarily indicative of the results that may be expected for
the entire fiscal year. The accompanying financial information should be read in conjunction with
the financial statements and the notes thereto in our most recent Annual Report on Form 10-K. The
December 31, 2004 balance sheet has been derived from the audited financial statements on Form
10-K. Certain reclassifications have been made to the prior years condensed consolidated
financial statements to conform to classifications used in the current year. All share data has
been restated to reflect stock splits.
We are considered a development stage company since most of our efforts to date have been
devoted to raising capital, recruiting management and developing markets, and revenues earned to
date from operations have not been significant.
Note 2. Acquisition of Intellectual Property
On
June 22, 2005, we and our wholly-owned subsidiary, Hythiam International (Cayman) Ltd.,
entered into an asset purchase agreement with Dr. Jacob Hiller to obtain the worldwide rights to
his trade secret protocols for the treatment of nicotine and drug dependence, in exchange for a
percentage of future net profits from exploitation of the protocols. In addition, as part of our
European expansion strategy, Hythiam International (Cayman) Ltd. purchased the operating assets of
Dr. Hillers clinic in Spain, and its wholly-owned subsidiary, Hythiam International Sàrl, engaged
Dr. Hiller as a consultant and is taking over the clinic operations.
Note 3. Cash Equivalents and Marketable Securities
We invest available cash in short-term commercial paper, certificates of deposit and high
grade variable rate securities. Liquid investments with an original maturity of three months or
less when purchased are considered to be cash equivalents.
Investments, including auction rate securities, with maturity dates greater than three months
when purchased which have readily determined fair values are classified as available-for-sale
investments and reflected in current assets as marketable securities at fair market value. Auction
rate securities are recorded at par value, which equals fair market value, as the rate on such
securities resets generally every 7, 28 or 35 days.
Note 4. Basic and Diluted Loss per Share
In accordance with Statement of Financial Accounting Standards (SFAS) 128, Computation of
Earnings Per Share, basic loss per share is computed by dividing the net loss to common
stockholders for the period by the weighted average number of common shares outstanding during the
period. Diluted loss per share is computed by dividing the net loss for the period by the weighted
average number of common and dilutive common equivalent shares outstanding during the period.
Common equivalent shares, consisting of 6,942,000 and 5,667,000 of incremental common shares
as of June 30, 2005 and 2004, respectively, issuable upon the exercise of stock options and
warrants have been excluded from the diluted earnings per share calculation because their effect is
anti-dilutive.
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A summary of the net loss and shares used to compute net loss per share is as follows (in
thousands, except per share data):
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2005 | 2004 | 2005 | 2004 | |||||||||||||
Net loss |
$ | (4,692 | ) | $ | (2,505 | ) | $ | (9,011 | ) | $ | (5,517 | ) | ||||
Basic and diluted loss per share |
$ | (0.16 | ) | $ | (0.10 | ) | $ | (0.30 | ) | $ | (0.22 | ) | ||||
Weighted average common shares used to
compute basic and diluted loss per share |
29,787 | 24,615 | 29,774 | 24,614 | ||||||||||||
Note 5. Share-Based Compensation
Stock options
Under our 2003 Stock Incentive Plan, we have granted options to employees and directors as
well as to non-employees for outside consulting services.
We account for the issuance of employee stock options using the intrinsic value method under
Accounting Principles Board Opinion No. 25 (APB 25), Accounting for Stock Issued to Employees.
Had we determined compensation cost based on the fair value at the grant date for our employee
stock options under SFAS 123, Accounting for Stock-Based Compensation, the pro forma effect on
net loss and net loss per share would have been as follows (in thousands, except per share data):
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2005 | 2004 | 2005 | 2004 | |||||||||||||
Net loss, as reported |
$ | (4,692 | ) | $ | (2,505 | ) | $ | (9,011 | ) | $ | (5,517 | ) | ||||
Less: Share-based expense determined under
fair value based method |
(221 | ) | (111 | ) | (375 | ) | (222 | ) | ||||||||
Pro forma net loss |
$ | (4,913 | ) | $ | (2,616 | ) | $ | (9,386 | ) | $ | (5,739 | ) | ||||
Net loss per share |
||||||||||||||||
As reported basic and diluted |
$ | (0.16 | ) | $ | (0.10 | ) | $ | (0.30 | ) | $ | (0.22 | ) | ||||
Pro forma basic and diluted |
$ | (0.16 | ) | $ | (0.11 | ) | $ | (0.32 | ) | $ | (0.23 | ) |
The fair value of the options was estimated at the date of grant using the Black-Scholes
pricing model with the following weighted average assumptions for the three and six months ended
June 30, 2005 and 2004:
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2005 | 2004 | 2005 | 2004 | |||||||||||||
Expected volatility |
63 | % | 61 | % | 63 | % | 61 | % | ||||||||
Risk-free interest rate |
4.19 | % | 3.84 | % | 4.18 | % | 3.84 | % | ||||||||
Weighted average
expected lives in years |
10 | 10 | 10 | 10 | ||||||||||||
Expected dividend yield |
0 | % | 0 | % | 0 | % | 0 | % |
During the three and six months ended June 30, 2005 and the six months ended June 30, 2004, we
granted options for 595,000, 920,000 and 568,000 shares, respectively, to employees and directors
at the weighted average per share exercise price of $7.34, $6.77, and $5.86, respectively, the
fair market values at the dates of grant. No options were
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granted during the three months ended
June 30, 2004. Subsequently, in July 2005 we granted 361,000 shares to employees and consultants
at $5.78 per share, the fair market value at date of grant.
As of June 30, 2005, options for 450,000 shares granted to consultants and directors accounted
for under SFAS 123 were outstanding. These options vest over periods ranging from three to four
years and are being charged to expense as services are provided using the variable accounting
method. Non-vested options have an estimated fair value of approximately $1,172,000 as of June 30,
2005, using the Black-Scholes pricing model.
During the three and six months ended June 30, 2005 and 2004, share-based expense (income)
relating to stock options amounted to $122,000, $939,000, ($265,000) and $0, respectively.
Warrants
We account for the issuance of warrants for services from non-employees in accordance with
SFAS 123, by estimating the fair value of warrants issued using the Black-Scholes pricing model.
If warrants issued as compensation to non-employees for services are fully vested and
non-forfeitable at the time of issuance, the estimated value is recorded in equity and expensed
when the services are performed and benefit is received as provided by Financial Accounting
Standards Board Emerging Issues Task Force No. 96-18 . If warrants are issued for consideration in
an acquisition of assets, the value of the warrants are recorded in equity at the time of issuance
and included in the purchase price to be allocated.
During the six months ended June 30, 2005, we issued a warrant to purchase 25,000 shares of
common stock at $5.72 per share to a management advisor for investor relations services. The
warrant vested immediately and expires three years from date of grant. We also issued warrants to
purchase 20,000 shares of common stock to a management consultant, of which a warrant for 10,000
shares was issued at $2.80 per share, with immediate vesting and expires in 2014, and a warrant for
the remaining 10,000 shares was issued at $6.01 per share, with immediate vesting and expires in
2006. The total estimated fair value of warrants issued in the six months ended June 30, 2005 is
approximately $104,000 using the Black-Scholes pricing model.
During the three and six months ended June 30, 2005 and 2004, share-based expense (income)
relating to warrants amounted to $69,000, $288,000, ($24,000) and $248,000, respectively.
Common Stock
In March 2005, we issued 11,700 shares of common stock valued at $65,000 to a consultant
providing investor relation services, which is being amortized to expense on a straight-line basis
over the related six month service period. Share-based expense relating to stock issued for
outside services was $32,000, $65,000, $32,000 and $65,000 for the three and six months ended June
30, 2005 and 2004, respectively. Subsequently, in July 2005 we issued to this consultant an
additional 11,700 shares of common stock valued at $69,000, the fair market value at date of issue,
to be amortized over the related six month service period.
Note 6. Recent Accounting Pronouncements
In December 2004, the Financial Accounting Standards Board (FASB) issued SFAS 123(R),
Share-Based Payment, which addresses the accounting for employee stock options. SFAS 123(R)
revises the disclosure provisions of SFAS 123 and supersedes APB 25. SFAS 123(R) requires that
the cost of all employee stock options, as well as other equity-based compensation arrangements, be
reflected in the financial statements based on the estimated fair value of the awards. In March
2005, the Securities & Exchange Commission (the SEC) issued Staff Accounting Bulletin No. 107,
Share-Based Payment, which summarizes the views of the SEC staff regarding the interaction
between SFAS 123(R) and certain SEC rules and regulations, and is intended to assist in the initial
implementation. SFAS 123(R) is effective for all public companies that file as of the
beginning of the first interim or annual reporting period that begins after June 15, 2005.
However, in April 2005, the SEC announced that it would permit companies to implement this
statement at the beginning of their next fiscal year. We are currently evaluating the provisions
of SFAS
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123(R) and its effect on our financial statements. The effect of adopting this statement
will be to increase our compensation expense in the future.
In December 2004, the FASB issued SFAS 153, Exchanges of Nonmonetary Assets, an amendment of
APB 29, Accounting for Nonmonetary Transactions. This Statements amendments are based on the
principle that exchanges of nonmonetary assets should be measured based on the fair value of the
assets exchanged. Further, SFAS 153 eliminates the narrow exception for nonmonetary exchanges of
similar productive assets and replaces it with a broader exception for exchanges of nonmonetary
assets that do not have commercial substance. Provisions of this statement are effective for fiscal
periods beginning after June 15, 2005. We do not expect the adoption of this statement to have a
material impact on our financial statements.
In March 2005, the FASB issued FASB Interpretation No. 47, Accounting for Conditional Asset
Retirement Obligations (FIN 47), which is an interpretation of SFAS 143, Accounting for Asset
Retirement Obligations. FIN47 clarifies terminology within SFAS 143 and requires an entity to
recognize a liability for the fair value of a conditional asset retirement obligation when incurred
if the liabilitys fair value can be reasonably estimated. FIN 47 is effective for fiscal years
ending after December 15, 2005. We do not expect the adoption of this statement to have a material
impact on our financial statements.
In May 2005, the FASB issued SFAS 154, Accounting Changes and Error Corrections. SFAS 154
replaces APB 20, Accounting Changes and SFAS 3, Reporting Accounting Changes in Interim Financial
Statements and establishes retrospective application as the required method for reporting a change
in accounting principle. SFAS 154 provides guidance for determining whether retrospective
application of a change in accounting principle is impracticable and for reporting a change when
retrospective application is impracticable. The reporting of a correction of an error by restating
previously issued financial statements is also addressed. SFAS 154 is effective for accounting
changes and corrections of errors made in fiscal years beginning after December 15, 2005.
We do not expect the adoption of this statement to have a material impact on our
financial statements.
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ITEM 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
The following discussion of our financial condition and results of operations should be read
in conjunction with our financial statements and the related notes, and the other financial
information included in this report.
Forward-Looking Statements
The forward-looking comments contained in this report involve risks and uncertainties. Our
actual results may differ materially from those discussed here due to factors such as, among
others, limited operating history, difficulty in developing, exploiting and protecting proprietary
technologies, intense competition and substantial regulation in the healthcare industry.
Additional factors that could cause or contribute to such differences can be found in the following
discussion, as well as in the Risks Factors set forth in Item 1 of Part I of our Annual Report on
Form 10-K filed with the Securities and Exchange Commission on March 31, 2005.
Overview
Hythiam, Inc. is a development stage healthcare services management company, focused on
delivering solutions for those suffering from alcoholism and other substance dependencies. We
research, develop, license and commercialize innovative physiological treatment protocols for
substance dependence. Our proprietary Prometa protocols
(formerly HANDS® protocols) are designed for use by healthcare providers
to treat those diagnosed with dependence to alcohol, cocaine and methamphetamine, as well as
combinations of these drugs. The Prometa protocols include medically supervised procedures designed
to target receptor sites in the brain that regulate neurotransmitters implicated in brain processes
of substance dependence. The Prometa protocols also provide for a maintenance program that includes
medications and incentives for patients to continue with their recovery process through
individualized continuing care programs. As a result, our Prometa protocols represent a comprehensive
approach to managing substance dependence that is designed to address both the physiological and
psychological aspects of the disease, thereby offering patients an opportunity to transition into a
healthier lifestyle.
We generate revenues by charging fees to licensed healthcare providers for access to our
proprietary protocols for use in treating their patients. We also provide administrative services
to assist physicians and facilities with staff education, marketing and sales support, and outcomes
tracking for data analysis.
In the first half of 2005, we entered into 11 new licensing agreements, bringing the total
number of licensees to 18 at June 30, 2005. In the same period, 80 patients completed treatment
using our Prometa protocols. We expanded our corporate office space during the second quarter to
accommodate our increasing staff and have leased and are building out
medical office space that will be occupied by a medical group to whom
we have agreed to provide turn-key business management services and a
license to use our protocol beginning in the third quarter of this
year, in exchange for a management and licensing fee.
In the second quarter, we signed two contracts with independent researchers to provide
unrestricted grants for the study of the Prometa protocol: one for a randomized, controlled study
comparing our Prometa protocols to standard medical treatment for alcohol dependence, and the second
for a controlled study to investigate our Prometa protocols for the treatment of methamphetamine
dependence.
We established two wholly-owned foreign subsidiaries for the purpose of licensing our
intellectual property in foreign markets, and entered into an agreement to acquire protocols for
the treatment of nicotine and drug dependence in Europe. Although we have not commenced any
foreign operations to date, we are planning to open several clinics in Europe in the second half of
2005.
On August
4, 2005, we announced the branding of our proprietary protocols. The
new name, Prometa, will replace the HANDS Protocols® as we
enter the marketing pre-launch phase of our business. Our goal was to
create a brand name that would support the positioning of the
protocols and differentiate them from traditional treatment options.
Our protocols provide a medical
treatment intervention, of shorter duration, separate and distinct
from residential treatment and the few chronic anti-craving
pharmaceuticals that exist on the market. We believe Prometa better communicates this treatment protocol.
Results of Operations
We have a limited history of operations, have not yet commenced substantial marketing
activities, and have not generated significant revenues from operations. Our revenues are
generated from fees that we charge to hospitals, healthcare facilities and other healthcare
providers that license our Prometa protocols. Our license agreements provide
for a 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 will be the number of facilities and healthcare providers that contract with
us to license our technology and the number of patients that are treated by
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those providers using
our Prometa protocols. We believe that the number of patients treated by our licensees will increase
over time as our marketing, advertising and branding activities are implemented and clinical
outcomes data from research studies become available.
Revenues
Our revenues for the three and six month periods ended June 30, 2005 were $230,000 and
$433,000, respectively, compared to $5,000 and $72,000 in the comparable periods last year.
The increase in revenues was driven by licensing fees earned from
healthcare sites which completed treatment of a total of 40 patients in
the quarter. By the end of the second quarter of 2005, there were six
operational licensee sites contributing to revenues at some level,
compared to just one operational site in the same period last year.
In the second quarter of 2005, we entered into four new
licensing agreements with hospitals and healthcare providers,
bringing the total number of licensees to 18 at June 30, 2005. During the first half of 2005, 80 patients
completed treatment using our Prometa protocols, compared to 16 patients in the same period last
year. As we look forward to the third quarter, we now have 19 contracted licensees, of
which 8 should be operational and contributing towards revenues. As we deploy
the new brand identity and accelerate local marketing activity, we should see an
increase in patient traffic toward the end of this calendar year and then on a
sequential basis in calendar 2006. However, until each of the licensed treatment centers becomes fully operational and local
marketing programs are in place to increase public awareness, we expect a minimal increase in
patient activity in the third quarter of 2005. Thus far, new sites
have typically started generating revenues after an initial four to
six-month training and start-up period following contract signing.
Pre-operational site initiation activities include the hiring and training of a local site manager,
the education and training of the licensee physicians and staff in
the Prometa protocols, the
development of a local marketing plan and the mutual approval by both parties in the implementation
plan for site launch.
Our license agreements provide for a 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 contract with us to license our proprietary protocols and
the number of patients that are treated by those providers using the
Prometa protocols.
Expenses
We have devoted a substantial portion of our financial resources to the payment of salaries
and benefits, legal and professional services, and other general and administrative expenses during
our start-up period.
Our operating expenses during the three and six month periods ended June 30, 2005 were $5.1
million and $9.8 million, respectively, compared to $2.5 million and $5.7 million, respectively,
for the same periods last year. The increase in operating expenses in 2005 over 2004 reflects the
continued development of our company and the execution of our business plan, including a national
expansion strategy, hiring of key management personnel, investing in clinical research and the
marketing of our Prometa protocols.
Salaries and benefits expenses were $2.3 million and $3.9 million for the three and six month
periods ended
June 30, 2005, compared to $1.4 million and $2.7 million for the same in 2004. The increase for
both periods was due to increased staffing to serve our growing number of licensees as well the
strengthening of our executive management team to implement our business plan.
In the three and six month periods ended June 30, 2005, our other operating expenses were $2.6
million and $5.5 million, respectively, versus $1.0 million and $2.7 million, respectively, last
year, including non-cash charges (credits) of $224,000, $1.3 million, ($257,000) and $311,000,
respectively, relating to share-based expense. Other operating expenses payable in cash for the
three and six months ended June 30, 2005 were $2.4 million and $4.2 million, respectively, compared
to $1.2 million and $2.3 million, respectively, for the same periods last year. Major components of
our other operating expenses include legal, audit, insurance, travel and entertainment, rent,
investor and public relations, clinical research, marketing, and other professional consulting
costs. The increases in 2005 over the comparable periods in 2004 in most expense categories are
generally proportionate to the overall increase in staffing and infrastructure of our company, with
additional spending in 2005 for clinical research studies, legal and consulting costs for
international expansion, accounting and consulting costs for Sarbanes-Oxley compliance and new
marketing and business development activities.
As of June 30, 2005, we have substantially completed the hiring of our senior management team
and a substantial portion of our corporate management and supporting staff. As we enter into new
licensing agreements, we will
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continue to hire additional site managers and supporting operational
staff. Accordingly, our salaries, benefits and travel related expenses will continue to increase
with the growth in our business. Additionally, we are planning to significantly increase our
marketing efforts in the second half of 2005 to provide for local marketing and advertising as well
as brand awareness on both a local and national level. We will also
allocate up to $3 million in the second half of 2005 towards clinical
studies and our patient outcomes registry.
International Operations
In June 2005, we and our international subsidiary Hythiam International (Cayman) Ltd. entered
into an asset purchase agreement to obtain the worldwide rights to certain trade secret protocols
for the treatment of nicotine and drug dependence, in exchange for a percentage of future net
profits from exploitation of the protocols. In addition, as part of our European expansion
strategy, we have incorporated two wholly owned foreign subsidiaries and have engaged consultants
to explore opportunities to start up clinic operations for the treatment of nicotine dependence in
several European countries. As of June 30, 2005, we had not begun any international operations.
Liquidity and Capital Resources
We have financed our operations since inception primarily through the sale of shares of our
stock. At June 30, 2005 we had approximately $20.0 million in cash, cash equivalents and marketable
securities after raising net proceeds of approximately $21.3 million from a private placement of
our stock in December 2004.
Since we are a developing business, both our current and prior operating costs are not
representative of our expected future costs. As we continue to implement commercial operations and
allocate significant and increasing resources to business development, hire additional personnel,
expand our market and engage in other start-up activities, we expect our cash operating expenses in
the second half of 2005 to increase from our current average of
approximately $1.4 million per
month as we enter into additional licensing agreements and increase
our marketing efforts to provide for local marketing and advertising
as well as brand awareness on both a local and national level.
As of June 30, 2005, we have committed approximately $1.4 million to provide funding for
unrestricted grants for research studies for our Prometa protocol. We are currently in the process
of awarding additional grants to investigators to test the efficacy
of the Prometa protocol through
the conduct of studies in special patient populations, open label studies for alcohol and
methamphetamine dependence, and controlled, double-blind studies conducted by leading researchers
in the field of substance dependence, for which we plan to allocate an additional $1.6 million in
funding this year. In addition, we have initiated a patient outcomes registry to be conducted by a
Contract Research Organization to monitor and evaluate outcomes of approximately 750 patients
undergoing treatment using the Prometa protocol at our commercial licensee sites. The combined cost
of the studies and patient registry is estimated at approximately $8 million over the next two
years.
In April 2005, we signed a five year lease for medical office space in Santa Monica,
California, at an initial base rent of $19,000 per month commencing in August 2005. We estimate our
build-out costs for tenant improvements will be approximately $700,000. We plan to sublease this
space to a medical group to whom we have agreed to provide turn-key
business management services and a license to use our protocol
beginning in the third quarter of this year in exchange for a
management and licensing fee.
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 costs associated with the
effectiveness of marketing our protocols, obtaining regulatory approvals and preparing, filing,
prosecuting, maintaining and enforcing patent claims and other proprietary rights. Additionally,
our future expenditures will depend on competing technological and market developments and our
ability to establish collaborative arrangements, effective commercialization, marketing activities
and other arrangements.
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We expect to continue to incur negative cash flows and net losses for at least the next twelve
months. Based upon our current plans and the lack of sales
predictability at this stage of our development, we believe that our
existing cash reserves may not be
sufficient to meet our operating expenses and
capital requirements before we achieve profitability. Accordingly, we
most likely will seek 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. In April 2005, we filed a shelf registration statement on Form S-3 that will enable us to
sell up to an additional $30 million of our common stock from time to time in one or more
offerings. We may not be successful in raising necessary funds on acceptable terms, or at all.
Contractual Obligations and Commercial Commitments
The following table sets forth a pro forma summary of our material minimum contractual
obligations and commercial commitments as of June 30, 2005 (in thousands):
Less than 1 | More than 5 | |||||||||||||||||||
Contractual Obligations | Total | year | 1-3 years | 3-5 years | years | |||||||||||||||
Operating lease obligations(1) |
$ | 4,376 | $ | 742 | $ | 1,612 | $ | 1,708 | $ | 314 | ||||||||||
Contractual
commitments for clinical studies |
1,354 | 729 | 625 | | | |||||||||||||||
$ | 5,730 | $ | 1,471 | $ | 2,237 | $ | 1,708 | $ | 314 | |||||||||||
(1) | Consists of our current lease obligations for our corporate office and a medical office. | |
Off-Balance Sheet Arrangements
As of June 30, 2005 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 treatment protocols and providing administrative
services to hospitals, treatment facilities and other healthcare providers. We determine revenues
earned based on the terms of these contracts, which determination requires the use of judgment,
including the assessment of the collectibility of receivables. Licensing agreements typically
provide for a fixed fee on a per-patient basis, payable to us upon completion of the patients
initial treatment using our protocol. For revenue recognition purposes, we treat the protocol
licensing and related marketing and administrative services as one unit of accounting. We record
the fees owed to us under the terms of the agreements as revenue in the period in which the
patients medically supervised treatment has been completed.
Share-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 models calculations
include the exercise price, the market price of shares on grant date, weighted average assumptions
for risk-free interest rates, expected life of the option or warrant, expected volatility of our
stock and expected dividend yield. The amounts recorded in the financial statements for
share-based 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
continue 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 1 to our audited financial statements
included in our Annual Report on Form 10-K for the year ended December 31, 2004.
Recent Accounting Pronouncements
In December 2004, the Financial Accounting Standards Board (FASB) issued SFAS 123(R),
Share-Based Payment, which addresses the accounting for employee stock options. SFAS 123(R)
revises the disclosure provisions of SFAS 123 and supersedes APB 25. SFAS 123(R) requires that
the cost of all employee stock options, as well as other equity-based compensation arrangements, be
reflected in the financial statements based on the estimated fair value of the awards. In March
2005, the Securities & Exchange Commission (the SEC) issued Staff Accounting Bulletin No. 107,
Share-Based Payment, which summarizes the views of the SEC staff regarding the interaction
between SFAS 123(R) and certain SEC rules and regulations, and is intended to assist in the initial
implementation. SFAS 123(R) is effective for all public companies that file as of the
beginning of the first interim or annual reporting period that begins after June 15, 2005.
However, in April 2005, the SEC announced that it would permit companies to implement this
statement at the beginning of their next fiscal year. We are currently evaluating the provisions
of SFAS 123(R) and its effect on our financial statements. The effect of adopting this statement
will be to increase our compensation expense in the future.
In December 2004, the FASB issued SFAS 153, Exchanges of Nonmonetary Assets, an amendment of
APB 29, Accounting for Nonmonetary Transactions. This Statements amendments are based on the
principle that exchanges of nonmonetary assets should be measured based on the fair value of the
assets exchanged. Further, SFAS 153 eliminates the narrow exception for nonmonetary exchanges of
similar productive assets and replaces it with a broader exception for exchanges of nonmonetary
assets that do not have commercial substance. Provisions of this statement are effective for fiscal
periods beginning after June 15, 2005. We do not expect the adoption of this statement to have a
material impact on our financial statements.
In March 2005, the FASB issued FASB Interpretation No. 47, Accounting for Conditional Asset
Retirement Obligations (FIN 47), which is an interpretation of SFAS 143, Accounting for Asset
Retirement Obligations. FIN 47 clarifies terminology within SFAS 143 and requires an entity to
recognize a liability for the fair value of a conditional asset retirement obligation when incurred
if the liabilitys fair value can be reasonably estimated. FIN 47 is effective for fiscal years
ending after December 15, 2005. We do not expect the adoption of this statement to have a material
impact on our financial statements.
In May 2005, the FASB issued SFAS 154, Accounting Changes and Error Corrections. SFAS 154
replaces
APB 20, Accounting Changes and SFAS 3, Reporting Accounting Changes in Interim Financial
Statements and establishes retrospective application as the required method for reporting a change
in accounting principle. SFAS 154 provides guidance for determining whether retrospective
application of a change in accounting principle is impracticable and for reporting a change when
retrospective application is impracticable. The reporting of a correction of an error by restating
previously issued financial statements is also addressed. SFAS 154 is effective for accounting
changes and corrections of errors made in fiscal years beginning after December 15, 2005.
We do not expect the adoption of this statement to have a material 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, 2004.
ITEM 4. Controls and Procedures
We have evaluated, 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. There were no changes in the internal controls over financial
reporting that occurred during the quarter ended June 30, 2005 that have materially affected, or
are reasonably likely to materially affect, our internal control over financial reporting.
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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 filing, 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. Unregistered Sales of Equity Securities and Use of Proceeds
In January 2005, we issued a three-year warrant to purchase 25,000 shares of common stock at
$5.72 per share to a management advisor for investor relations services. In January 2005, we also
granted warrants to purchase 20,000 shares of common stock to a management consultant, of which a
warrant for 10,000 shares was issued at $2.80 per share and expires in 2014, and a warrant for the
remaining 10,000 shares was issued in May 2005, at $6.01 per share, and expires in 2006. These
securities were issued without registration pursuant to the exemption afforded by Section 4(2) of
the Securities Act of 1933, as transactions by us not involving any public offering.
In March 2005 we issued 11,700 shares of common stock and in July 2005 we issued an additional
11,700 shares of common stock to a consultant providing investor relation services. These
securities were issued without registration pursuant to the exemption afforded by Section 4(2) of
the Securities Act of 1933, as transactions by us not involving any public offering.
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 17, 2005. There
were 24,484,924 shares present in person or by proxy. Our stockholders elected all of
the boards 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: |
For | Withheld | |||||||
Terren S. Peizer |
24,172,562 | 312,362 | ||||||
Anthony M. LaMacchia |
24,168,507 | 316,417 | ||||||
Leslie F. Bell, Esq. |
24,372,477 | 112,447 | ||||||
Herve de Kergrohen, M.D. |
24,375,507 | 109,417 | ||||||
Ivan M. Lieberburg, Ph.D., M.D. |
24,375,522 | 109,402 | ||||||
Richard A. Anderson |
24,169,562 | 315,362 | ||||||
Marc G. Cummins |
24,375,507 | 109,417 |
(2) | Amendment of 2003 Stock Incentive Plan: |
For |
15,773,447 | |||
Against |
1,297,667 | |||
Abstain |
21,401 |
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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, 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.
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, | ||
| the effectiveness of our planned advertising, marketing and promotional campaigns, | ||
| physician and patient acceptance of our products and services, including newly introduced products, | ||
| competition among addiction treatment centers, | ||
| anticipated trends and conditions in the industry in which we operate, including regulatory changes, | ||
| development of new treatment modalities, | ||
| our future capital needs and our ability to obtain financing, and | ||
| 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
Exhibit 31.1 Certification of Chief Executive Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
Exhibit 31.2 Certification of Chief Financial Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
Exhibit 32.1 Certification of Chief Executive Officer pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002
Exhibit 32.2 Certification of Chief Financial Officer pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002
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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. | ||||
Date: August 4, 2005
|
By: | /S/ TERREN S. PEIZER | ||
Terren S. Peizer President and Chief Executive Officer |
||||
Date: August 4, 2005
|
By: | /S/ CHUCK TIMPE | ||
Chuck Timpe Chief Financial Officer |
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